Simulation method and system of needleless injector, computer equipment and storage medium

Abstract

The invention relates to the field of needleless injectors, in particular to a simulation method and system of a needleless injector, computer equipment and a storage medium. The method comprises the following steps: acquiring drug administration parameters in a to-be-simulated needle-free injection scene, performing dynamic simulation operation, and generating power output parameters and motion control parameters required by a jet flow to penetrate through skin; carrying out electromagnetic simulation operation according to the power output parameters, and generating and outputting structural parameters and electrical parameters of the power driving module; performing structure simulation operation according to the power output parameters and the motion control parameters to generate container structure parameters of the medicine container module; based on a preset skin mechanical model, fluid mechanical simulation is conducted according to the motion control parameters and the container structure parameters, and the drug diffusion state is simulated; when the medicament diffusion state meets a preset diffusion state, outputting corresponding container structure parameters; based on this, design parameters of the needleless injector are determined. The simulation accuracy and effectiveness are improved, and the innovative development of the needleless injector is promoted.

Description

Technical Field

[0001] The present invention relates to the field of needle-free injectors, and in particular to a simulation method and system for a needle-free injector, a computer device and a storage medium. Background Art

[0002] In the field of needle-free syringes, spring-powered needle-free syringes have undergone years of research and development and market verification, and have formed a relatively mature design and manufacturing process, and have occupied a certain share in the market. However, with the advancement of medical technology and the improvement of patients' requirements for treatment experience, this traditional technology has gradually revealed its limitations. For example, the power output of spring drive is limited, and it is difficult to achieve precise control, which may affect the efficiency and accuracy of drug delivery. In contrast, as a new generation of technology, electromagnetic-powered needle-free syringes have shown great potential and development prospects due to their high efficiency, precision and adjustability. This type of syringe uses electromagnetic force to push the liquid medicine, which can generate a strong thrust in a very short time, thereby ensuring that the drug can penetrate the skin at a very high speed, reach deeper tissues, and improve drug absorption rate.

[0003] At present, the development process of most needle-free syringes is still highly dependent on the professional knowledge and personal experience of R&D personnel. R&D personnel often design new products based on previous successful cases and intuitive judgments, and test and adjust them by repeatedly making physical prototypes. Although this method is simple and direct, it has many shortcomings: on the one hand, it is time-consuming and labor-intensive and increases material costs. It is difficult to accurately predict the actual performance of the product, resulting in a long R&D cycle and low efficiency; on the other hand, over-reliance on experience and trial and error methods limits the innovative thinking space of R&D personnel, easily causing products to fall into homogeneous competition and making it difficult to achieve real technological innovation. Especially in the face of emerging electromagnetic-powered needle-free syringes, in order to give full play to the advantages of electromagnetic drive, such as optimizing the magnetic field distribution to achieve the best thrust curve, ensuring the uniformity and consistency of the liquid during high-speed injection, etc., it is necessary to integrate complex expertise in multiple fields such as electromagnetics, fluid mechanics, and materials science, requiring R&D personnel to have multidisciplinary knowledge and technical integration capabilities. At the same time, experience and trial and error alone cannot overcome a series of complex engineering problems in electromagnetic drive, further increasing the cost and difficulty of innovation.

[0004] The field of needle-free syringes is facing a critical period of transition from traditional spring-powered technology to more advanced electromagnetic-powered technology. However, the R&D and innovation of needle-free syringes is costly, difficult, and inefficient, which has become a bottleneck restricting the further development of the industry and limiting the sustainable development of needle-free injections. Summary of the invention

[0005] The main purpose of the present invention is to provide a simulation method and system for a needle-free syringe, a computer device and a storage medium. In order to solve the above-mentioned technical problems, the present invention specifically adopts the following technical solutions: The first aspect of the present invention is to provide a simulation method for a needle-free syringe, wherein the needle-free syringe comprises a power driving module, a motion execution module, and a medicine container module, wherein the power driving module outputs power so that the motion execution module pushes the medicine in the medicine container module to form a jet flow to penetrate the skin to complete the injection operation, and the method comprises: S101 obtains medication parameters in a needle-free injection scenario to be simulated, wherein the medication parameters include at least one of an injection object type, an injection drug type, and an injection drug dose; S102 performs a dynamic simulation operation based on the drug administration parameters to generate power output parameters and motion control parameters required for the jet to penetrate the skin; S103 performs electromagnetic simulation calculation according to the power output parameters to generate and output at least one set of structural parameters and electrical parameters of the power drive module; S104 performs structural simulation calculation according to the power output parameters and motion control parameters to generate at least one set of container structural parameters of the drug container module, and executes step S105; S105: obtaining a preset skin mechanics model corresponding to the drug administration parameters; based on the preset skin mechanics model, performing fluid mechanics simulation according to the motion control parameters and the container structure parameters to simulate the drug diffusion state during the injection process; when at least one drug diffusion state satisfies the preset diffusion state, outputting the corresponding container structure parameters and executing step S106; otherwise, executing step S104 to update the container structure parameters; S106 determines the design parameters of the needle-free syringe according to the output structural parameters, electrical parameters, and container structural parameters.

[0006] In some embodiments, the method also includes: obtaining the manufacturing process limitations and user usage requirements of the needle-free syringe, and setting parameter boundary thresholds for the parameters generated by each simulation operation based on the manufacturing process limitations and the user usage requirements, and the parameter boundary thresholds include the minimum and / or maximum values ​​of the parameters; when any parameter is identified as exceeding the corresponding parameter boundary threshold, the parameter exceeding the parameter boundary threshold is removed, and / or the corresponding simulation operation is performed to update the parameters exceeding the parameter boundary threshold.

[0007] In some embodiments, the parameter boundary threshold includes a first preset size; S103 includes: determining the expected size of each group of the corresponding power drive module according to each group of the structural parameters and the electrical parameters; if there is at least one group of expected sizes smaller than the first preset size, output the corresponding structural parameters and the electrical parameters, and execute step S104; otherwise, execute step S102 to update the power output parameters and the motion control parameters.

[0008] In some embodiments, the parameter boundary threshold includes a preset displacement, the motion control parameter includes a displacement parameter, and S102 includes: when the displacement parameter is less than the preset displacement, re-execute step S102 to update the power output parameter and the motion control parameter; and / or, the parameter boundary threshold includes a second preset size, and the container structure parameter includes a liquid inlet size parameter; S104 includes: if at least one of the liquid inlet size parameters is less than the second preset size, output the corresponding container structure parameter and execute step S105; otherwise, re-execute step S104 to update the container structure parameters.

[0009] In some embodiments, before S106, it also includes: when there is only one set of the structural parameters, the electrical parameters, and the container structural parameters, the structural parameters are used as the target structural parameters, the electrical parameters are used as the target electrical parameters, and the container structural parameters are used as the target container structural parameters; when there are at least two sets of the structural parameters and the electrical parameters, and / or when there are at least two sets of the container structural parameters, the target structural parameters, the target electrical parameters, and the target container structural parameters are determined according to a parameter preferred threshold, wherein the parameter preferred threshold includes a preferred value range of the parameter.

[0010] In some embodiments, the design parameters of the needle-free syringe include: a first design parameter, a second design parameter, and a third design parameter; the S106 includes: generating the first design parameter of the power drive module according to the target structural parameters and the target electrical parameters; generating the second design parameter of the drug container module according to the target container structural parameters; generating the third design parameter of the remaining modules of the needle-free syringe based on the first design parameter and the second design parameter.

[0011] In some embodiments, the S102 also includes: calculating the stagnation pressure threshold of the drug jet penetrating the skin based on a preset pressure calculation formula according to the injection drug type, the injection drug dosage, and the injection object type; performing dynamic simulation calculations according to the stagnation pressure threshold, and outputting the required power output parameters and the motion control parameters.

[0012] The second aspect of the present invention is to provide a simulation system for a needle-free syringe, wherein the needle-free syringe comprises a power drive module, a motion execution module, and a medicine container module, wherein the power drive module outputs power so that the motion execution module pushes the medicine in the medicine container module to form a jet flow to penetrate the skin to complete the injection operation, and the system comprises: An operation parameter module, used to obtain drug administration parameters in a needle-free injection scenario to be simulated, wherein the drug administration parameters include at least one of an injection object type, an injection drug type, and an injection drug dose; A dynamics simulation module, used for performing dynamics simulation calculation based on the drug administration parameters to generate power output parameters and motion control parameters required for the jet to penetrate the skin; An electromagnetic simulation module, used for performing electromagnetic simulation calculation according to the power output parameters, generating and outputting at least one set of structural parameters and electrical parameters of the power drive module; A structural simulation module, used for performing structural simulation calculation according to the power output parameters and motion control parameters to generate at least one set of container structural parameters of the drug container module; A fluid mechanics simulation module, used for obtaining a preset skin mechanics model corresponding to the drug administration parameters; based on the preset skin mechanics model, performing fluid mechanics simulation according to the motion control parameters and the container structure parameters to simulate the drug diffusion state during the injection process; when at least one drug diffusion state satisfies the preset diffusion state, outputting the corresponding container structure parameters; otherwise, updating the container structure parameters; The design parameter module is used to determine the design parameters of the needle-free syringe according to the output structural parameters, electrical parameters and container structural parameters.

[0013] A third aspect of the present invention is to provide a computer device, the computer device comprising a memory and a processor; The memory is used to store computer programs; The processor is used to execute the computer program and implement the steps of the needle-free injector simulation method provided in any embodiment of the present invention when executing the computer program.

[0014] According to a fourth aspect of the present invention, a computer-readable storage medium is provided, wherein the computer-readable storage medium stores a computer program, and when the computer program is executed by a processor, the processor performs the steps of the method for simulating a needle-free syringe as provided in any embodiment of the present invention.

[0015] Beneficial technical effects: The present invention proposes a modular simulation process, which aims to achieve interdisciplinary composite operation splitting through multi-level simulation of dynamics, electromagnetism, structural science and fluid mechanics. Appropriate interface parameters are selected between different levels as a bridge for information transmission, so that multiple simulation operations can interact with each other at different levels, and finally merge into an overall design scheme for needle-free syringes, breaking down disciplinary barriers, realizing collaborative simulation between different fields, simplifying the simulation process and the difficulty of simulation operations, improving the efficiency and accuracy of simulation, and further reducing the difficulty of research and development and the cost of innovation. At the same time, the hierarchical arrangement and parameter screening mechanism of multi-level simulation are optimized, and the simulated needle-free syringe can ensure that the drug can effectively penetrate the skin and achieve the expected therapeutic effect, while combining actual manufacturing considerations and user experience requirements, taking into account the cost and production process feasibility, ensuring that the product has good market competitiveness and promotion potential, further improving the practicality and effectiveness of simulation, and promoting the innovative development of needle-free syringes. The details are as follows: 1. Multi-level simulation task decomposition Complex simulation tasks are broken down into multiple levels, each of which focuses on specific behaviors or parameters. Lower-level simulations focus on macroscopic or overall behaviors. For example, dynamic simulations are used to determine the power output parameters and motion control parameters that control needle-free injection operations. These initial parameters ensure that the drug can effectively penetrate the skin from a macroscopic perspective. Higher-level simulations (such as electromagnetic simulations and structural simulations) go deeper into local or microscopic behaviors based on overall behaviors, and perform more detailed parameter simulations on the core components of needle-free syringes, the power drive module and the drug container module, for example, the electrical and structural parameters of the power drive module and the container structure parameters of the drug container module. Higher-level simulations (such as fluid mechanics simulations) verify the validity of the generated simulation data, and fine-tune the structural simulation results to find parameter configurations that are closer to the optimal value, to ensure that the drug can effectively penetrate the skin and achieve the expected therapeutic effect.

[0016] Among them, power output parameters and motion control parameters were selected as interfaces between different levels, which simplified the simulation architecture while maintaining sufficient descriptive capabilities so that simulations in other fields can directly use these two key parameters for interaction, simplifying the simulation process and the difficulty of simulation operations and improving simulation efficiency.

[0017] 2. Optimize simulation hierarchy arrangement In order to improve the practicality and efficiency of the simulation, the order of multi-level simulation is optimized, and the simulation priority of the power drive module is set to take precedence over the drug container module. The power drive module determines the weight and volume of the product and is crucial for market promotion. Through pre-electromagnetic simulation, the key parameters of the power drive module can be determined as early as possible to avoid repeated simulation work caused by updating the power output parameters.

[0018] 3. Parameter screening mechanism Each simulation operation sets up a two-level parameter screening mechanism based on multiple dimensions such as cost control, process difficulty, volume weight, and energy conversion rate, further eliminating the possibility that the data range is too wide and the values ​​are not accurate enough due to simulation based on only two initial parameters, and realizing the restriction and optimization of the design parameters of the needle-free syringe, ensuring that all parameters are within a reasonable range and close to the optimal values, and improving the reliability of the simulation results. On the one hand, strict boundary threshold limits are imposed on all parameters through parameter boundary thresholds to ensure the feasibility of the simulation results. For example, the size of the power drive module is limited by the first preset size, and the parameters with too large size are removed or regenerated. On the other hand, the parameter optimization threshold is used to secondary screen the parameters that are closer to the optimal value among the multiple sets of parameters that meet the performance, further improving the performance and reliability of the product.

[0019] Moreover, the entire simulation process only makes necessary parameter restrictions on some parameters of the core module from the perspective of the performance and scalability of the needle-free syringe, which provides sufficient freedom for the design of the entire needle-free syringe and promotes the research and development innovation of the needle-free syringe. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings required for use in the embodiments or the prior art descriptions are briefly introduced below. In all the drawings, similar elements or parts are generally identified by similar reference numerals. In the drawings, each element or part is not necessarily drawn according to the actual scale. Obviously, the drawings described below are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can also be obtained based on these drawings without paying creative labor.

[0021] Figure 1 is a schematic flow chart of a simulation method for a needle-free injector provided in an embodiment of the present invention; Figure 2 is a schematic flow chart of another simulation method for a needle-free injector provided in an embodiment of the present invention; Figure 3 is a schematic block diagram of a simulation system for a needle-free injector provided in an embodiment of the present invention; Figure 4 It is a schematic block diagram of the structure of a computer device provided by an embodiment of the present invention. DETAILED DESCRIPTION

[0022] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of the present invention.

[0023] Herein, suffixes such as "module", "component" or "unit" used to represent elements are only used to facilitate the description of the present invention, and have no specific meanings by themselves. Therefore, "module", "component" or "unit" can be used mixedly.

[0024] In this document, the terms "upper", "lower", "inner", "outer", "front", "back", "one end", "the other end" and the like indicate positions or positional relationships based on the positions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed and operate in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first" and "second" are used for descriptive purposes only and cannot be understood as indicating or implying relative importance.

[0025] In this document, unless otherwise clearly specified and limited, the terms "installed", "provided with", "connected", etc. should be understood in a broad sense. For example, "connected" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection, a direct connection, or an indirect connection through an intermediate medium, or it can be the internal communication of two components. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0026] Herein "and / or" includes any and all combinations of one or more of the associated listed items.

[0027] Herein, "plurality" means two or more than two, ie, it includes two, three, four, five, etc.

[0028] It should be noted that, in this article, the terms "include", "comprises" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, an element defined by the sentence "comprises a ..." does not exclude the existence of other identical elements in the process, method, article or device including the element.

[0029] Although traditional spring-powered needle-free syringes have occupied an important position in the market, their technical limitations are gradually emerging. The power output of the spring drive is limited, and it is difficult to achieve precise control, which may lead to inefficient drug delivery and insufficient accuracy. In addition, as the number of uses increases, the spring is prone to fatigue and loss, affecting the long-term stability and reliability of the device. These factors limit its applicability in certain high-demand application scenarios, such as treatment plans that require frequent injections or have strict requirements on dosage accuracy. With the advancement of medical technology and the enhancement of health awareness, patients' requirements for treatment experience are also constantly increasing. They expect safer, more comfortable and efficient injection methods to reduce pain, fear and potential infection risks. Electromagnetic-powered needle-free syringes can provide a smoother, faster and almost painless injection experience, while reducing the risk of cross-infection, meeting patients' needs for higher-quality medical services.

[0030] Globally, the medical device industry is experiencing rapid technological innovation. As a cutting-edge technology, electromagnetic powered needle-free injectors are in line with the general trend of industry development and urgently need to use innovative technologies to promote the transformation of the entire industry to electromagnetic power. However, the R&D and innovation costs in the industry are high, difficult, and inefficient, which has become a bottleneck restricting the further development of the industry and limiting the sustainable development of needle-free injection.

[0031] Based on this, the present invention proposes a modular simulation process, which aims to realize interdisciplinary composite operation splitting through multi-level simulation of dynamics, electromagnetism, structural science and fluid mechanics. Appropriate interface parameters are selected between different levels as a bridge for information transmission, so that multiple simulation operations can interact with each other at different levels, and finally merge into an overall design scheme for needle-free syringes, breaking down disciplinary barriers, realizing collaborative simulation between different fields, simplifying the simulation process and the difficulty of simulation operations, improving the efficiency and accuracy of simulation, and further reducing the difficulty of research and development and the cost of innovation. At the same time, the hierarchical arrangement and parameter screening mechanism of multi-level simulation are optimized, and the simulated needle-free syringe can ensure that the drug can effectively penetrate the skin and achieve the expected therapeutic effect, while combining actual manufacturing considerations and user experience requirements, taking into account the cost and production process feasibility, ensuring that the product has good market competitiveness and promotion potential, further improving the practicality and effectiveness of simulation, and promoting the innovative development of needle-free syringes.

[0032] For example, a needle-free injector is a medical device that uses a non-invasive method to deliver drugs directly into the subcutaneous tissue or muscle tissue of the human body. The needle-free injector includes a power drive module, a motion execution module, and a drug container module. The power drive module outputs power so that the motion execution module pushes the drug in the drug container module to form a high-speed jet flow to penetrate the skin to complete the injection operation.

[0033] Among them, the power drive module is used to provide the necessary energy to drive the entire injection process. For example, the needle-free syringe with electromagnetic drive technology has an electromagnetic motor as its power drive module.

[0034] The motion execution module is used to convert the energy generated by the power drive module into mechanical motion, that is, to push the medicine in the medicine container module to form a jet flow. The motion execution module can be a push rod, a piston, a plunger or other forms of propulsion mechanism, and a seal can be set at the contact part between the propulsion mechanism and the inner wall of the medicine container to ensure that the medicine will not leak from the side under high pressure environment.

[0035] The drug container module is used to store the medicine to be injected, and the drug container module can be an ampoule or other forms of storage mechanism. In the design of the drug container module of the needle-free syringe, two key openings or ports are usually involved, namely, the liquid inlet for loading the drug into the drug container and the ejection port for ejecting the drug from the container at high speed.

[0036] It should be understood that in the design of needle-free syringes, the seal is used to ensure good sealing between the propulsion mechanism and the inner wall of the drug container, prevent drug leakage and maintain internal pressure. In order to achieve the best sealing effect, the cross-sectional area of ​​the seal must be highly related to the cross-sectional area of ​​the drug container module. Exemplarily, the outer diameter (cross-sectional area) of the seal must precisely match the inner diameter (cross-sectional area) of the drug container to ensure close contact between the two. If the seal is too large, it will cause installation difficulties and unnecessary friction; if the seal is too small, it will not provide sufficient sealing effect.

[0037] Specifically, when the needle-free injector is started, the power drive module generates power (such as electromagnetic force) and converts this power into mechanical motion through the motion execution module to push the medicine in the drug container module. Under the action of high pressure, the medicine quickly forms a small and high-speed jet stream, penetrates the skin and enters the subcutaneous or muscle tissue, completing the needle-free injection process.

[0038] Some embodiments of the present invention are described in detail below in conjunction with the accompanying drawings. The following embodiments and features of the embodiments can be combined with each other without conflict. Figure 1 , Figure 1 is a schematic flow chart of a simulation method for a needle-free syringe provided by an embodiment of the present invention, such as Figure 1 As shown, the method includes steps S101 to S106.

[0039] S101 obtains medication parameters in a needle-free injection scenario to be simulated, where the medication parameters include at least one of an injection object type, an injection drug type, and an injection drug dose.

[0040] Specifically, the drug administration parameters in the needle-free injection scenario to be simulated are determined through experimental research, clinical trial data, etc. Among them, the drug administration parameters are a collection of a series of key parameters involved in the needle-free injection process, such as the type of injection object, the type of injection agent, the injection agent dosage, the injection depth, the injection diffusion, etc. These parameters affect the behavior of the agent in the needle-free injection process. Through the drug administration parameters, accurate simulation can be achieved to meet the needs of different needle-free injection scenarios, ensuring that the drug solution can properly penetrate and reach the target level.

[0041] The injection drug type is used to determine the characteristics of the drug in the simulated needle-free injection scenario, such as the viscosity of the drug solution, which directly affects the fluidity of the drug solution. Drugs with high viscosity require higher pressure to overcome internal friction and injection resistance; for example, the density of the drug solution determines the required thrust, and heavier drugs may require greater force to push; for example, the cohesive force between drug molecules, which affects the dispersion and penetration efficiency during injection, thereby indirectly affecting the required pressure. The injection object type is used to determine the characteristics of the skin and tissue in the simulated needle-free injection scenario, such as skin thickness, which affects the diffusion of the drug solution after entering the tissue, and harder tissues may require higher pressure to ensure the effective distribution of the drug; for example, the hydration state of the skin, and the appropriate moisture level will optimize the absorption and diffusion of the drug solution. It should be understood that the characteristics of the skin and tissues are different between different organisms (such as humans, dogs, pigs, cows, etc.), and the skin thickness of the same organism will also vary in different parts of the body (such as arms, thighs, abdomen, etc.). The injection dose is used to determine the injection volume of the drug in the simulated needle-free injection scenario. The amount of drug injected each time can determine the injection speed, which directly affects the speed and pressure of the jet flow.

[0042] S102 performs a dynamic simulation operation based on the drug administration parameters to generate power output parameters and motion control parameters required for the jet to penetrate the skin.

[0043] Specifically, based on dynamic simulation, the interaction between the jet and the skin in the simulation scenario corresponding to the injection object type, injection drug type, injection drug dosage and other parameters in the drug administration parameters is simulated, and the optimal power output parameters and motion control parameters required to penetrate the skin are determined.

[0044] Among them, the power output parameter is used to characterize the parameters required by the motor to provide mechanical power, including but not limited to the output value of the electromagnetic motor, such as thrust or power. The power output parameter determines the maximum thrust, acceleration and continuous driving ability that the propulsion mechanism can obtain, determines the propulsion pressure during the injection process, and thus determines whether the drug solution can penetrate the skin at a sufficient speed and reach the target tissue layer.

[0045] Among them, motion control parameters are used to characterize the key motion-related parameters of the propulsion mechanism during the entire injection process, including speed, acceleration, displacement, etc. Motion control parameters determine the speed and duration of drug injection, and ideal motion control parameters can accelerate the drug to an appropriate speed in the shortest time and maintain a stable injection process.

[0046] It should be understood that the power output parameter provides the energy source required to move the propulsion mechanism, but it does not directly determine the specific motion behavior of the propulsion mechanism. Instead, it affects the speed of the propulsion mechanism by providing different thrust levels. Correspondingly, the motion control parameter depends on the thrust provided by the power output characteristics, but its core lies in how to accurately control the motion behavior of the push rod. In other words, the power output parameters and motion control parameters are closely linked. The former provides the necessary energy basis for the latter, and the latter uses this energy to achieve precise motion control. Together, they determine the speed, accuracy and consistency of the drug injection. The power output characteristics focus on the mechanical power provided by the motor and its conversion efficiency, emphasizing the source and quality of energy; while the motion control parameters pay more attention to the actual motion behavior of the push rod, emphasizing how to efficiently and accurately use this energy to complete the drug delivery task.

[0047] In the multi-level simulation, power output parameters and motion control parameters are selected as interfaces. They are directly related to the movement of the core propulsion mechanism in the needle-free injection process. The propulsion pressure ensures that the drug solution can overcome the skin barrier and reach the predetermined depth, while the injection speed ensures that the drug can be evenly diffused in a short time to avoid excessive concentration or insufficient dispersion, which in turn has a significant impact on the overall behavior of the needle-free injection process. Only two key parameters are selected to represent as much information as possible. The subsequent series of simulations will be based on these two parameters, which simplifies the entire simulation architecture and can effectively improve the speed and accuracy of the entire simulation process, as well as the reliability of the simulation results.

[0048] In some embodiments, the S102 also includes: calculating the stagnation pressure threshold of the drug jet penetrating the skin based on a preset pressure calculation formula according to the injection drug type, the injection drug dosage, and the injection object type; performing dynamic simulation calculations according to the stagnation pressure threshold, and outputting the required power output parameters and the motion control parameters.

[0049] The stagnation pressure threshold refers to the initial resistance generated when the jet encounters the skin surface, and the additional resistance encountered as the drug enters the tissue. The preset pressure calculation formula is used to estimate the stagnation pressure threshold required for the drug jet to penetrate the skin during needle-free injection. This formula needs to consider multiple factors including drug properties, skin and tissue properties of the injected object, injection dose, etc. The preset pressure calculation formula can be constructed based on these factors, and is not limited here.

[0050] Specifically, based on the preset pressure calculation formula, the stagnation pressure threshold required for the drug jet to penetrate the skin is first calculated according to the type of injected drug, dosage and type of injection object. For example, the stagnation pressure threshold for humans can be 15MPa, and the stagnation pressure threshold for pigs can be 20MPa. Then, the stagnation pressure threshold is used for dynamic simulation calculations. By simulating the physical phenomena of drug flow, tissue reaction and injection process, the power output parameters and motion control parameters that can reach the critical point of skin breaking are optimized and output, so that the drug can safely and effectively penetrate the skin during needle-free injection.

[0051] It should be understood that dynamic simulation is a one-dimensional simulation, which is a lower-level simulation in the multi-level simulation of the embodiment of the present invention. It focuses on the basic key issues in the macroscopic or overall behavior, that is, whether the needle-free injector has the ability to effectively penetrate the skin. The output power output parameters and motion control parameters ensure that the power in the injection operation meets the injection standards.

[0052] S103 performs electromagnetic simulation calculation according to the power output parameters to generate and output at least one set of structural parameters and electrical parameters of the power drive module.

[0053] Specifically, electromagnetic simulation operation simulates the behavior of the power drive module (such as electromagnetic motor) under different conditions through a computer to output at least one set of structural parameters and electrical parameters that meet the power output parameters. Among them, the structural parameters are design parameters related to the physical structure and mechanical properties of the power drive module, including the geometric dimensions of the power drive module such as outer diameter, inner diameter, length, etc.; and the specific dimensions of internal components, such as the dimensions of the stator and rotor, the dimensions of the magnetic steel, the dimensions of the winding wire, etc. The electrical parameters are the behavioral characteristics of the power drive module during the power conversion process, including but not limited to the voltage, current, resistance, inductance, power, etc. of the power drive module.

[0054] It should be understood that due to user requirements, the total weight of needle-free syringes is generally limited. By optimizing the structural parameters and electrical parameters simultaneously, the overall volume and weight of the motor can be accurately controlled in the early stages of the design, which not only meets the high performance requirements but also maintains a lightweight design, thereby improving the user experience. In addition, the re-simulation of the power drive module requires the update of the power output parameters. The pre-processing can effectively avoid the repeated re-simulation of other simulation processes due to the update of the power output parameters, improve the accuracy and practicality of the simulation, save R&D time and resources, and effectively improve the efficiency and quality of the simulation.

[0055] S104 performs structural simulation calculation according to the power output parameters and motion control parameters to generate at least one set of container structural parameters of the drug container module, and executes step S105.

[0056] Specifically, the scenario of injection operation under power output parameters and motion control parameters is simulated, and structural simulation calculation is performed in this scenario. On the one hand, the basic structural parameters of the container (such as wall thickness, shape, material selection) are designed, and through multiple iterations of optimization, the key performance indicators of the container, such as strength, stiffness, durability and safety, are evaluated to ensure that the drug container will not explode due to high pressure; on the other hand, the structural parameters of the liquid inlet and injection port of the container are designed to ensure that the drug can effectively penetrate the skin and achieve the expected therapeutic effect. Based on this, at least one set of container structural parameters is output.

[0057] S105 obtains a preset skin mechanics model corresponding to the drug administration parameters; based on the preset skin mechanics model, performs fluid mechanics simulation according to the motion control parameters and the container structure parameters to simulate the drug diffusion state during the injection process; when at least one of the drug diffusion states satisfies the preset diffusion state, outputs the corresponding container structure parameters and executes step S106; otherwise, executes step S104 to update the container structure parameters.

[0058] Among them, the preset skin mechanics model is a mathematical model pre-constructed based on biomechanical properties (such as elastic modulus, viscoelastic behavior and tissue structure) to simulate and predict the response behavior of the skin during drug injection, such as the diffusion state. The preset diffusion state is a parameter value of the diffusion state that is pre-set to meet the requirements of treatment effect, patient comfort, etc., which can be determined according to the actual injection scenario and is not limited here.

[0059] Specifically, a suitable preset skin mechanics model is selected or constructed according to the drug administration parameters. This model should be able to accurately reflect the biomechanical properties of the target injection area, including but not limited to the elastic modulus, viscoelastic behavior, tissue hierarchy and vascular distribution of the skin. Then, the selected skin mechanics model is used, combined with motion control parameters (such as injection speed, acceleration, etc.) and container structure parameters (such as container shape, wall thickness, material properties, etc.), through fluid mechanics simulation calculations, to simulate the subcutaneous flow and diffusion behavior of the drug during injection, such as depth, diffusion, uniformity, penetration rate, etc. When there is at least one set of fluid mechanics simulation results showing that the drug diffusion state meets the preset diffusion state, the corresponding container structure parameters are output and the subsequent steps are continued. If the fluid mechanics simulation results fail to reach the preset diffusion state, it is necessary to return to the simulation stage of the container structure parameters to adjust and optimize the design, such as changing the size or structure of the injection port. Different sizes or structures of the injection port will affect the injection form of the drug solution, such as linear and spray, and then affect the diffusion state such as the depth and diffusion of the jet flow into the skin.

[0060] It should be understood that structural simulation operations are performed based on the power output parameters and motion control parameters to generate the container structure parameters of the drug container module, and the skin mechanics model is used to verify whether the requirements and reliability are met to ensure that the drug can effectively penetrate the skin and achieve the expected therapeutic effect. On the basis of the two initial parameter simulations, the structural simulation results are fine-tuned to find parameter configurations that are closer to the optimal values.

[0061] In some embodiments, injectable oily vaccines are all non-Newtonian fluids, and their viscosity coefficients will increase with the increase of force. During the fluid mechanics simulation calculation process, the fluid parameters are set according to the type of injected medicine, or a viscosity and force curve corresponding to the type of injected medicine is input to improve the accuracy and effectiveness of the simulation.

[0062] S106 determines the design parameters of the needle-free syringe according to the output structural parameters, electrical parameters, and container structural parameters.

[0063] Specifically, the output structural parameters and electrical parameters may exist in one or more groups, and the container structural parameters may also exist in one or more groups. At least one group of core parameters is obtained by arbitrarily combining these parameters, wherein each group of core parameters includes target structural parameters, target electrical parameters, and target container structural parameters. At least one group of design parameters of the needle-free syringe in the simulation scenario is determined based on these core parameters.

[0064] Among them, design parameters refer to the specific parameter values ​​in the design of needle-free syringes, such as the size, shape and arrangement of the magnetic steel and the number of turns of the coil corresponding to the target structural parameters; the control board specifications and control circuit design corresponding to the target electrical parameters; and the structure and size of the injection port corresponding to the target container structural parameters. It further includes the specific parameter values ​​of other key components of the needle-free syringe, such as the structural dimensions of the propulsion mechanism and its seals. Determining other design parameters based on these core parameters can ensure the efficient coordination of various components to achieve efficient and safe drug delivery. It should be understood that the design parameters are not completely equivalent to the parameters of the simulation output. For example, electrical parameters are current, voltage, etc., and the design parameters corresponding to the electrical parameters are control board specifications and control circuit design.

[0065] In some embodiments, the design parameter package of the needle-free syringe; a first design parameter, a second design parameter, and a third design parameter; the S106 includes: generating the first design parameter of the power drive module according to the target structural parameters and the target electrical parameters; generating the second design parameter of the drug container module according to the target container structural parameters; generating the third design parameter of the remaining modules of the needle-free syringe based on the first design parameter and the second design parameter.

[0066] Specifically, the first design parameters are determined based on the target structural parameters and the target electrical parameters. This part of the design parameters is used to produce the power drive module, including the core design parameters of the power drive module that have been determined by the two, and other design parameters of the power drive module generated based on these core design parameters, thereby generating sufficient pressure to push the drug through a tiny opening to form a high-speed jet stream. The second design parameters are determined based on the target container structural parameters. This part of the design parameters is used to produce the drug container module, including the core design parameters of the drug container module that have been determined by the target container structural parameters, and other design parameters of the drug container module generated based on these core design parameters, thereby ensuring that the drug is effectively and safely stored and injected. The third design parameters are generated based on the first design parameters and the second design parameters, and are used to define the design of other components of the needle-free syringe, such as the design of the propulsion mechanism and the seal.

[0067] It should be understood that the actual product design is very complex. Through simulation, some key parameters of the core power drive module and drug container module in the needle-free syringe can be quickly determined, and other design parameters of the needle-free syringe can be flexibly generated based on these key parameters. Among them, the specific method of generating parameters can use a pre-generated model, or it can be designed by R&D personnel based on market demand, professional knowledge, and personal experience. On the one hand, it simplifies the simulation process and the difficulty of simulation calculations, and improves the simulation efficiency. On the other hand, on the basis of ensuring the effectiveness of research and development, it provides sufficient freedom for the design of the entire needle-free syringe, broadens the innovative thinking space of R&D personnel, and promotes the research and development innovation of needle-free syringes.

[0068] It should be noted that, in the embodiment of the present invention, the simulation operation used in each step is flexibly set according to specific goals and requirements. Different simulation stages are intended to solve specific problems or simulate specific phenomena, so specific simulation goals are set for each stage, such as verifying theoretical assumptions, optimizing design parameters, or predicting system behavior. Exemplarily, the goal and requirement of the dynamic simulation operation is to determine the optimal power output parameters and motion control parameters required to penetrate the skin. The goal and requirement of the electromagnetic simulation operation is to determine the design parameters of the power drive module to ensure that it can provide enough energy to achieve the required injection speed and pressure according to the power output parameters. The goal and requirement of the structural simulation operation is to consider the geometric structure, material properties, external loads and possible operating environment of the drug container module through the power output parameters and motion control parameters, and then comprehensively evaluate the performance and safety of the drug container module under different conditions, and output the container structure parameters. The goal and requirement of the fluid mechanics simulation is to evaluate the injection effect according to the motion control parameters and the container structure parameters to further optimize the container structure parameters.

[0069] In order to achieve these goals, the simulation process is based on the physical principles of Newtonian mechanics, fluid mechanics, electromagnetism, mechanical engineering and materials science, and the most appropriate mathematical model is selected for modeling. According to the characteristics of the problem, the appropriate numerical method is selected to accurately set the boundary conditions (such as fixed ends, free ends, periodic boundaries) and initial conditions (such as displacement, velocity, temperature) of the simulation operation to ensure that the simulation process can be started reasonably and reflect the actual situation. The specific simulation algorithm can be flexibly designed according to the actual situation and is not limited here. For example, dynamic simulation may rely on Newtonian mechanics to determine the power output and motion control parameters of the needle-free injection operation; electromagnetic simulation will use Maxwell's equations to analyze the electrical characteristics of the power drive module; structural simulation uses solid mechanics to evaluate the structural integrity of the drug container module; and fluid mechanics simulation uses the Navier-Stokes equations to ensure the effectiveness and safety of drug delivery.

[0070] The selection of mathematical models for each step of the simulation is tailored to the phenomenon to be simulated in order to improve the accuracy of the simulation and promote collaborative work between different disciplines, providing a scientific basis and technical support for the design of needle-free syringes.

[0071] In some embodiments, the design of the needle-free syringe needs to follow strict medical device design and manufacturing standards, and the boundary conditions in each simulation operation can be set based on this. At the same time, the design of the needle-free syringe also needs to be extensively tested to ensure safety and effectiveness, especially when there are multiple sets of design parameters, all or part of the design parameters can be selected to make physical prototypes for physical testing, and screen out design parameters that perform better in the test and are easier to promote production.

[0072] During the simulation process, adjusting parameters seems to be just modifying the values ​​in the software, but in actual engineering applications, fine-tuning of certain parameters may significantly affect the cost and manufacturing difficulty. Therefore, when conducting preliminary simulations, it is necessary to consider the actual engineering problems at the same time, and set the corresponding boundary conditions and screening mechanisms for the parameters of the simulation operations according to these actual problems to ensure the feasibility and manufacturability of the design, which helps to avoid unnecessary design changes and cost overruns in the later stage, and ensure that the product meets the performance requirements and can be efficiently produced within a reasonable budget. By comprehensively considering the overall simulation results and engineering reality, the design scheme can be optimized, performance and cost can be balanced, and the effectiveness and reliability of the needle-free syringe simulation can be ensured.

[0073] Based on this, each simulation operation sets up a two-level parameter screening mechanism based on multiple dimensions such as cost control, process difficulty, volume weight, and energy conversion rate, further eliminating the possibility that the data range is too wide and the values ​​are not accurate enough due to simulation based on only two initial parameters, thereby limiting and optimizing the design parameters of needle-free syringes, ensuring that all parameters are within a reasonable range, and improving the reliability of the overall simulation results.

[0074] In some embodiments, the method also includes: obtaining the manufacturing process limitations and user usage requirements of the needle-free syringe, and setting parameter boundary thresholds for the parameters generated by each simulation operation based on the manufacturing process limitations and the user usage requirements, and the parameter boundary thresholds include the minimum and / or maximum values ​​of the parameters.

[0075] Among them, manufacturing process limitations refer to the capabilities and limitations of current manufacturing technology, as well as the manufacturing process selection determined by manufacturing costs. Manufacturing process limitations are directly related to the structural design, dimensional tolerances and other physical properties of needle-free syringes. For example, when selecting materials, it is necessary to take into account both availability and cost-effectiveness, the processing accuracy requirements of key components such as nozzles and magnetic steels, the complexity of the assembly process and the control of the number of components, as well as the difficulty of implementing the overall process, etc., which are not limited here.

[0076] Among them, user usage requirements are the specific expectations of the target user group for the functional characteristics and user experience of needle-free syringes, including but not limited to volume and weight, energy conversion rate, safety and reliability, ease of use, and ease of cleaning and maintenance. Specifically, information on the needs of the target user group can be collected through market research, user feedback and clinical testing, which is not limited here.

[0077] Specifically, based on the manufacturing process limitations of needle-free syringes and user requirements, reasonable boundary thresholds, i.e., the lowest and / or highest values ​​of the parameters, are set for each key parameter generated by the simulation operation. These thresholds should satisfy both the feasibility of the manufacturing process and the actual usage requirements of the user.

[0078] For example, market research found that current manufacturing technology has limitations in the manufacture of ampoule spray nozzles. When the drug container module is an ampoule, spray nozzles larger than 0.02 mm are easier to manufacture and have a longer mold life; however, the difficulty of mold opening for spray nozzles with a diameter of more than 0.1 mm is significantly increased, the mold is more vulnerable, and the corresponding service life is shortened. Therefore, the larger the diameter of the spray nozzle, the stronger the machinability. Selecting a moderate spray nozzle diameter helps to balance manufacturing feasibility and cost-effectiveness. At the same time, the structure and size of the spray nozzle must ensure that the drug can be sprayed at the correct speed and angle. Therefore, for the spray nozzle diameter parameter generated by the structural simulation operation, the parameter boundary threshold can be set to a maximum value of 0.14 mm, so that the diameter of the spray nozzle meets the cost-effectiveness and process feasibility requirements, and / or a minimum value of 0.02 mm, so that the diameter of the spray nozzle meets the performance requirements of needle-free injection and ensures the injection effect.

[0079] In some embodiments, the parameter boundary threshold can be built-in as a boundary condition in the simulation algorithm, and can also be externally set as a parameter output condition after the simulation operation. For example, when the injection performance of the needle-free syringe is considered as the main factor and the volume weight is secondary, the diameter parameter of the injection port is used as the built-in boundary condition of the simulation operation, and the magnetic steel size parameter is used as the external parameter output condition. For another example, when the injection performance of the needle-free syringe is considered as the main factor and the cost-effectiveness is secondary, for the diameter parameter of the injection port, the lowest value of 0.02mm is used as the built-in boundary condition of the simulation operation, and the highest value of 0.14mm is used as the external parameter output condition, that is, the lowest value of the parameter boundary threshold is used as the built-in boundary condition of the simulation operation, and the highest value of the parameter boundary threshold is used as the external parameter output condition.

[0080] In some embodiments, when any parameter is identified to exceed the corresponding parameter boundary threshold, the parameter exceeding the parameter boundary threshold is removed to eliminate the interference of invalid parameters and improve the validity and reliability of the simulation results. Alternatively, when any parameter is identified to exceed the corresponding parameter boundary threshold, the corresponding simulation operation is performed to update the parameter exceeding the parameter boundary threshold to ensure that the number of valid parameters generated meets the design requirements and provides a sufficient data basis for subsequent parameter screening.

[0081] In some embodiments, different processing strategies can be selected for different parameters of different modules, and diversified simulation results with different preferences can be output for R&D personnel to choose, thereby improving the practicality and flexibility of the simulation. It can be flexibly applied according to actual needs and is not limited here. Exemplarily, for the parameters of some modules, when it is identified that any parameter exceeds the corresponding parameter boundary threshold, the parameters exceeding the parameter boundary threshold are removed. Correspondingly, for the parameters of some other modules, when it is identified that any parameter exceeds the corresponding parameter boundary threshold, the corresponding simulation operation is performed to update the parameters exceeding the parameter boundary threshold.

[0082] In some embodiments, since a higher-level simulation operation can generate at least one set of parameters (such as structural parameters and electrical parameters, container structure parameters), at least one set of parameters can be screened by a parameter boundary threshold. When there is at least one set of parameters that meets the parameter boundary threshold, the corresponding parameters are output as simulation results. Otherwise, the corresponding simulation operation is performed again to update the corresponding parameters. It should be noted that the aforementioned parameter boundary threshold is built-in as a boundary condition in the simulation algorithm and / or externally set as a parameter output condition after the simulation operation.

[0083] Exemplarily, the parameter boundary threshold includes a first preset size; S103 includes: determining the expected size of each group of the power drive module corresponding to each group of the structural parameters and the electrical parameters; if there is at least one group of expected sizes smaller than the first preset size, outputting the corresponding structural parameters and the electrical parameters, and executing step S104; otherwise, executing step S102 to update the power output parameters and the motion control parameters.

[0084] Among them, the first preset size is used to limit the volume and weight of the power drive module, which is determined based on the manufacturing process limitations of the needle-free syringe and user usage requirements. The specific value can be flexibly set according to the actual survey situation and is not limited here.

[0085] Specifically, based on each set of structural parameters and electrical parameters, the expected size (such as volume, weight) of the power drive module designed based on the structural parameters and electrical parameters is estimated. If the expected size of the power drive module corresponding to at least one set of structural parameters and electrical parameters is less than the preset first size threshold, the set of parameters is considered to be valid parameters, at least one set of valid parameters is output, and the simulation proceeds to the next step; if none of them meet the first preset size requirement, it indicates that the current combination of structural parameters and electrical parameters is not suitable for practical application, and no valid structural parameters and electrical parameters will be output, but the previous simulation step will be returned, that is, the dynamic simulation calculation will be re-performed based on the drug administration parameters (such as drug dosage, injection speed, etc.), and the power output parameters and motion control parameters required for the jet to penetrate the skin will be re-generated.

[0086] It should be understood that if at least one set of structural parameters and electrical parameters obtained by the simulation operation fails to meet the first preset size requirement, there are two paths to choose from: one is to re-execute the current step S103 and re-perform the electromagnetic simulation to generate new structural parameters and electrical parameters; the other is to directly return to step S102 and re-perform the dynamic simulation operation to directly generate new power output parameters and motion control parameters.

[0087] Preferably, step S102 is executed, and the regenerated power output parameters and motion control parameters will be used to update the existing design, thereby starting a new round of iteration process. Through this feedback mechanism, the structural parameters and electrical parameters can be continuously adjusted and optimized until a set of optimal solutions that meet both performance indicators and manufacturing constraints are found.

[0088] In the first round of electromagnetic simulation, multiple sets of simulation results have been output, and the needle-free syringe has limitations such as manufacturing process, user requirements, and medical equipment design and manufacturing standards. The design flexibility of the power drive module is actually quite limited. In contrast, in the lower-level dynamic simulation, we only need to focus on the macro and overall behavior of the needle-free injection operation, and ensure that the drug can effectively penetrate the skin from a macro perspective. In order to control the amount of calculation for subsequent simulations, only a set of initial power output parameters and motion control parameters are output. Directly executing step S102 has higher feasibility and effectiveness, reduces the number of iterations, and improves simulation efficiency.

[0089] Furthermore, based on this optimization, the hierarchical arrangement of the multi-level simulation is set to give the power drive module a simulation priority over the drug container module. The power drive module is a key determinant of the weight and volume of the syringe. By placing the electromagnetic simulation in advance, the structural parameters and electrical parameters of the power drive module are determined first, and then the weight and volume of the power drive module are determined. On the basis of improving the marketability and scalability of the product, the efficiency and practicality of the simulation are effectively improved. In addition, the re-simulation of the power drive module requires the update of the power output parameters. The pre-processing can effectively avoid the repeated re-simulation of other simulation processes due to the update of the power output parameters.

[0090] In the design of needle-free syringes, reducing the cross-sectional area of ​​the seal can significantly increase the stagnation pressure, but this will increase the complexity of seal selection and may even require customizing non-standard parts and opening molds, which will significantly increase time and procurement costs. Therefore, in both dynamic simulation and structural simulation, a two-level parameter screening mechanism needs to be set based on the seal cross-sectional area.

[0091] Exemplarily, the parameter boundary threshold includes a preset displacement, the motion control parameter includes a displacement parameter, and S102 includes: when the displacement parameter is less than the preset displacement, re-executing step S102 to update the power output parameter and the motion control parameter; and / or, the parameter boundary threshold includes a second preset size, and the container structure parameter includes a liquid inlet size parameter; S104 includes: if at least one of the liquid inlet size parameters is less than the second preset size, outputting the corresponding container structure parameter and executing step S105; otherwise, re-executing step S104 to update the container structure parameters.

[0092] Among them, the preset displacement is used to limit the displacement of the propulsion mechanism during the needle-free injection process, and the second preset size is used to limit the size of the diameter, cross-sectional area and other dimensional parameters of the liquid inlet. Both are determined based on the manufacturing process limitations of the needle-free syringe and the user's use requirements, and the specific size of the seal cross-sectional area also needs to be determined according to the application scenario. The specific value can be flexibly set according to the actual survey situation and is not limited here.

[0093] It should be understood that the volume of the injected drug dose is equal to the product of the cross-sectional area of ​​the seal and the stroke of the propulsion mechanism, and the cross-sectional area of ​​the seal must be highly correlated with the cross-sectional area of ​​the drug container module. Therefore, the cross-sectional area of ​​the seal in the simulation results can be effectively limited according to the above parameter settings.

[0094] Specifically, in step S102, when the displacement parameter is less than the preset displacement, step S102 will be re-executed to perform dynamic simulation calculation to update the power output parameter and motion control parameter. And / or, in step S104, if there is at least one liquid inlet size parameter less than the second preset size, the corresponding container structure parameter will be output, and the next step S105 will be executed to perform fluid mechanics simulation. If all liquid inlet size parameters do not meet the second preset size requirements, step S104 will be re-executed to perform structural simulation calculation to update the container structure parameters.

[0095] In some embodiments, before S106, it also includes: when there is only one set of the structural parameters, the electrical parameters, and the container structural parameters, the structural parameters are used as the target structural parameters, the electrical parameters are used as the target electrical parameters, and the container structural parameters are used as the target container structural parameters; when there are at least two sets of the structural parameters and the electrical parameters, and / or when there are at least two sets of the container structural parameters, the target structural parameters, the target electrical parameters, and the target container structural parameters are determined according to a parameter preferred threshold, wherein the parameter preferred threshold includes a preferred value range of the parameter.

[0096] The parameter optimization threshold is the preferred value range of each parameter defined according to manufacturing process restrictions, user requirements and medical device design standards, and is used to screen out the parameter combination that best meets the design standards and user requirements. For example, structural parameters such as magnet size and number of coil turns, electrical parameters such as current and voltage, and container structural parameters such as injection port and liquid inlet size can all be set with clear preferred ranges.

[0097] When the number of outputs during the simulation process is a single set of parameters, this set of parameters will be directly designated as the target structural parameters, target electrical parameters, and target container structural parameters without further screening or comparison, because there is only one set of available parameter combinations that can meet the current design requirements. When the number of outputs during the simulation process is multiple sets of parameters, that is, at least two sets of structural parameters and electrical parameters, or when there are at least two sets of container structural parameters, it is necessary to introduce parameter optimization thresholds to determine the optimal target parameters. All possible parameter combinations are evaluated, and those parameters that fall within the optimization threshold are selected as candidate target parameters. At least one set of core parameters will be obtained from any combination of these qualified candidate parameters, and the target structural parameters, target electrical parameters, and target container structural parameters will be finally determined.

[0098] Through the optimization mechanism based on parameter optimization thresholds, the optimal configuration can be found among multiple potential solutions, which improves the effectiveness and reliability of the simulation, thereby improving design efficiency and reducing development risks, ensuring that needle-free syringes can be successfully implemented in actual production.

[0099] For example, by selecting a combination of structural parameters and electrical parameters with lower current and voltage, the energy conversion rate of the needle-free syringe can be higher. The efficient energy conversion mechanism can ensure that the drug can be ejected at an appropriate pressure and speed, while minimizing energy consumption and extending battery life. For example, assuming that the total weight of the handheld terminal is required to be no more than 1,000 grams in the livestock and animal husbandry scenario, and the handheld terminal is required to be no more than 200 grams in the medical beauty scenario, a more matching weight can be selected according to the different usage scenarios of the needle-free syringe. For example, parameters with lower manufacturing costs and process difficulties can be selected, the cost-effectiveness ratio of different design schemes can be evaluated, and the design can be optimized to reduce costs without sacrificing quality or function.

[0100] It should be understood that, on the one hand, strict boundary threshold limits are imposed on all parameters through parameter boundary thresholds to ensure the feasibility of simulation results. On the other hand, the parameter optimization threshold is used to secondary screen parameters closer to the optimal value among multiple groups of parameters that meet the performance, further improving the performance and reliability of the product.

[0101] See also Figure 2 , Figure 2 FIG. 1 is a schematic flow chart of another simulation method for a needle-free injector provided in an embodiment of the present invention. Figure 2 As shown, the embodiment of the present invention decomposes a complex simulation task into multiple levels and refines the parameters layer by layer.

[0102] First, a lower-level simulation (such as one-dimensional dynamics simulation) is performed to focus on the macroscopic or overall behavior, and the control parameters of the needle-free injection operation are simulated. Two initial power output parameters and motion control parameters are output according to the drug administration parameters to ensure that the drug can effectively penetrate the skin from a macroscopic perspective. Then, from the two perspectives of power output and power control, subsequent higher-level simulations (such as one-dimensional electromagnetic simulation and structural simulation) are carried out, and power output parameters and motion control parameters are selected as interfaces. On the basis of the overall behavior simulation, local or microscopic behaviors are continued to be captured, and the core modules of the needle-free injector are simulated to output more refined parameters.

[0103] Next, by putting electromagnetic simulation in the front, the structural parameters and electrical parameters of the power drive module are determined first, and strict boundary threshold limits are imposed on the parameters through parameter boundary thresholds (such as expected size). For example, the expected size is compared with the first preset size. When the expected size is smaller than the first preset size, the corresponding structural parameters and electrical parameters are output as simulation results to ensure the feasibility of the simulation results. When the expected size is larger than the first preset size, the dynamic simulation is performed again to update the power output parameters and motion control parameters, and this cycle is repeated until the simulation obtains structural parameters and electrical parameters with expected sizes smaller than the first preset size.

[0104] It can be seen that the re-simulation of the power drive module requires updating the power output parameters, optimizing the hierarchical arrangement of the multi-level simulation, and setting the simulation priority of the power drive module over the drug container module, which can effectively avoid the repeated re-simulation of other simulation processes due to the update of the power output parameters.

[0105] Finally, the structural simulation operation is performed according to the power output parameters and motion control parameters to generate the container structural parameters of the drug container module, and the three-dimensional fluid mechanics simulation is performed through the skin mechanics model to simulate the drug diffusion state and compare the drug diffusion state with the preset diffusion state. When the drug diffusion state meets the preset diffusion state, the corresponding container structural parameters are output as the simulation result to ensure that the drug can effectively penetrate the skin and achieve the expected therapeutic effect. When the drug diffusion state does not meet the preset diffusion state, the structural simulation operation is performed again to update the container structural parameters, and this cycle is repeated until the simulation obtains the container structural parameters whose drug diffusion state meets the preset diffusion state. Among them, verifying whether the requirements and reliability are met through the skin mechanics model is also part of the two-level parameter screening mechanism.

[0106] Therefore, by introducing a multi-level, modular simulation process, the present invention not only breaks through the traditional R&D model that relies on experience and trial and error, but also successfully breaks the academic barriers between disciplines in the design of electromagnetic powered needle-free syringes. R&D personnel can focus on optimizing the corresponding simulation algorithms in their respective areas of expertise without having to fully master multidisciplinary knowledge, thereby greatly reducing the R&D threshold and the human cost of companies starting needle-free syringe projects. This interdisciplinary collaborative simulation method simplifies the development of needle-free syringes, improves R&D efficiency, and promotes the innovation of needle-free injection technology.

[0107] See also Figure 3 , Figure 3 A schematic block diagram of a simulation system for a needle-free injector provided in an embodiment of the present invention. The simulation system for a needle-free injector may be configured in a server to execute the simulation method for a needle-free injector described above.

[0108] like Figure 3As shown, the embodiment of the present invention further provides a simulation system 200 for a needle-free syringe, the needle-free syringe comprises a power driving module, a motion execution module, and a medicine container module, the power driving module outputs power so that the motion execution module pushes the medicine in the medicine container module to form a jet flow to penetrate the skin to complete the injection operation, the system comprises: An operation parameter module 201 is used to obtain drug administration parameters in a needle-free injection scenario to be simulated, wherein the drug administration parameters include at least one of an injection object type, an injection drug type, and an injection drug dose; A dynamics simulation module 202, for performing a dynamics simulation operation based on the drug administration parameters to generate power output parameters and motion control parameters required for the jet to penetrate the skin; The electromagnetic simulation module 203 is used to perform electromagnetic simulation calculation according to the power output parameters, generate and output at least one set of structural parameters and electrical parameters of the power drive module; A structure simulation module 204, used to perform structure simulation calculation according to the power output parameters and motion control parameters to generate at least one set of container structure parameters of the drug container module; The fluid mechanics simulation module 205 is used to obtain a preset skin mechanics model corresponding to the drug administration parameters; based on the preset skin mechanics model, perform fluid mechanics simulation according to the motion control parameters and the container structure parameters to simulate the drug diffusion state during the injection process; when at least one drug diffusion state satisfies the preset diffusion state, output the corresponding container structure parameters; otherwise, update the container structure parameters; The design parameter module 206 is used to determine the design parameters of the needle-free syringe according to the outputted structural parameters, electrical parameters and container structural parameters.

[0109] Exemplarily, the simulation system 200 for the needle-free injector further includes: a parameter boundary threshold module and a parameter removal and updating module.

[0110] A parameter boundary threshold module, used to obtain the manufacturing process restrictions and user usage requirements of the needle-free syringe, and set parameter boundary thresholds for the parameters generated by each simulation operation based on the manufacturing process restrictions and the user usage requirements, wherein the parameter boundary thresholds include the minimum and / or maximum values ​​of the parameters; The parameter removal and update module is used to remove the parameter exceeding the parameter boundary threshold when it is identified that any parameter exceeds the corresponding parameter boundary threshold, and / or to perform corresponding simulation operations to update the parameter exceeding the parameter boundary threshold.

[0111] Exemplarily, the parameter boundary threshold includes a first preset size; the electromagnetic simulation module 203 also includes: an expected size submodule and a size comparison submodule.

[0112] An expected size submodule, used to determine the expected size of each group of the corresponding power drive modules according to each group of the structural parameters and the electrical parameters; The size comparison submodule is used to output the corresponding structural parameters and electrical parameters and execute step S104 if there is at least one group of expected sizes smaller than the first preset size; otherwise, execute step S102 to update the power output parameters and the motion control parameters.

[0113] Exemplarily, the parameter boundary threshold includes a preset displacement, and the motion control parameter includes a displacement parameter; the dynamics simulation module 202 also includes: a preset displacement submodule, which is used to re-execute step S102 when the displacement parameter is less than the preset displacement to update the power output parameter and the motion control parameter.

[0114] Exemplarily, the parameter boundary threshold includes a second preset size, and the container structure parameter includes a liquid inlet size parameter; the structure simulation module 204 also includes: a liquid inlet size submodule, which is used to output the corresponding container structure parameter and execute step S105 if at least one of the liquid inlet size parameters is smaller than the second preset size; otherwise, re-execute step S104 to update the container structure parameters.

[0115] Exemplarily, the simulation system 200 for the needle-free injector further includes: a single simulation parameter module and multiple groups of simulation parameter modules.

[0116] a singular simulation parameter module, for taking the structural parameters as target structural parameters, the electrical parameters as target electrical parameters, and the container structural parameters as target container structural parameters when there is only one set of the structural parameters, the electrical parameters, and the container structural parameters; A plurality of simulation parameter modules are used to determine target structural parameters, target electrical parameters, and target container structural parameters according to parameter preferred thresholds when there are at least two sets of the structural parameters and the electrical parameters, and / or when there are at least two sets of the container structural parameters, wherein the parameter preferred thresholds include preferred value ranges of the parameters.

[0117] Exemplarily, the design parameters of the needle-free syringe include: a first design parameter, a second design parameter, and a third design parameter; the design parameter module 206 includes: a first design parameter submodule, a second design parameter submodule, and a third design parameter submodule.

[0118] A first design parameter submodule, configured to generate the first design parameter of the power drive module according to the target structural parameter and the target electrical parameter; A second design parameter submodule, used for generating the second design parameter of the drug container module according to the target container structure parameter; The third design parameter submodule is used to generate the third design parameters of the remaining modules of the needle-free injector based on the first design parameters and the second design parameters.

[0119] Exemplarily, the dynamics simulation module 202 further includes: a stagnation pressure submodule and a pressure penetration submodule.

[0120] A stagnation pressure submodule, for calculating the stagnation pressure threshold of the drug jet flow penetrating the skin based on a preset pressure calculation formula, according to the type of the injected drug, the dose of the injected drug, and the type of the injected object; The pressure penetration submodule is used to perform dynamic simulation calculation according to the stagnation pressure threshold and output the required power output parameters and motion control parameters.

[0121] Exemplarily, the above method and system may be implemented in the form of a computer program. The computer program may be implemented in the form of a computer program. Figure 4 Runs on the computer device shown.

[0122] See also Figure 4 , Figure 4 1 is a schematic block diagram of a computer device provided by an embodiment of the present invention. The computer device may be a terminal device or a server.

[0123] Exemplarily, the above method and system may be implemented in the form of a computer program. The computer program may be implemented in Figure 4 Runs on the computer device shown.

[0124] like Figure 4 As shown, the computer device includes a processor, a memory, and a network interface connected via a system bus, wherein the memory may include a non-volatile storage medium and an internal memory.

[0125] The non-volatile storage medium can store an operating system and a computer program. The computer program includes program instructions, and when the program instructions are executed, the processor can execute any needle-free injector simulation method.

[0126] The processor is used to provide computing and control capabilities and support the operation of the entire computer equipment.

[0127] The internal memory provides an environment for the operation of the computer program in the non-volatile storage medium. When the computer program is executed by the processor, the processor can execute any simulation method of the needle-free injector.

[0128] The network interface is used for network communication, such as sending assigned tasks, etc. Those skilled in the art will understand that Figure 4 The structure shown in the figure is only a block diagram of a part of the structure related to the solution of the present invention, and does not constitute a limitation on the computer device to which the solution of the present invention is applied. The specific computer device may include more or fewer components than those shown in the figure, or combine certain components, or have a different arrangement of components.

[0129] It should be understood that the processor may be a central processing unit (CPU), and the processor may also be other general-purpose processors, digital signal processors (DSP), application-specific integrated circuits (ASIC), field-programmable gate arrays (FPGA) or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. Among them, the general-purpose processor may be a microprocessor or the processor may also be any conventional processor, etc.

[0130] In one embodiment, the processor is used to run a computer program stored in the memory to implement the following steps: S101 obtains medication parameters in a needle-free injection scenario to be simulated, wherein the medication parameters include at least one of an injection object type, an injection drug type, and an injection drug dose; S102 performs a dynamic simulation operation based on the drug administration parameters to generate power output parameters and motion control parameters required for the jet to penetrate the skin; S103: performing electromagnetic simulation calculation according to the power output parameters to generate and output at least one set of structural parameters and electrical parameters of the power drive module; S104 performs structural simulation calculation according to the power output parameters and motion control parameters to generate at least one set of container structural parameters of the drug container module, and executes step S105; S105: obtaining a preset skin mechanics model corresponding to the drug administration parameters; based on the preset skin mechanics model, performing fluid mechanics simulation according to the motion control parameters and the container structure parameters to simulate the drug diffusion state during the injection process; when at least one drug diffusion state satisfies the preset diffusion state, outputting the corresponding container structure parameters and executing step S106; otherwise, executing step S104 to update the container structure parameters; S106 determines the design parameters of the needle-free syringe according to the output structural parameters, electrical parameters, and container structural parameters.

[0131] Exemplarily, the processor is used to run a computer program stored in the memory, and is also used to implement the steps of the needle-free injector simulation method provided in any embodiment of the present invention, which will not be described in detail here.

[0132] A computer-readable storage medium is also provided in an embodiment of the present invention, wherein the computer-readable storage medium stores a computer program, wherein the computer program includes program instructions, and the processor executes the program instructions to implement any one of the needle-free syringe simulation methods provided in the embodiments of the present invention.

[0133] The computer-readable storage medium may be an internal storage unit of the computer device described in the foregoing embodiment, such as a hard disk or memory of the computer device. The computer-readable storage medium may also be an external storage device of the computer device, such as a plug-in hard disk, a smart memory card (SmartMedia Card, SMC), a secure digital (Secure Digital, SD) card, a flash card (Flash Card), etc., equipped on the computer device.

[0134] The above is only a specific embodiment of the present invention, but the protection scope of the present invention is not limited thereto. Any technician familiar with the technical field can easily think of various equivalent modifications or replacements within the technical scope disclosed by the present invention, and these modifications or replacements should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be based on the protection scope of the claims.

Claims

1. A simulation method for a needle-free syringe, characterized in that: The needle-free injector comprises a power drive module, a motion execution module, and a drug container module. The power drive module outputs power so that the motion execution module pushes the medicine in the drug container module to form a jet flow to penetrate the skin to complete the injection operation. The method comprises: S101 obtains medication parameters in a needle-free injection scenario to be simulated, wherein the medication parameters include at least one of an injection object type, an injection drug type, and an injection drug dose; S102 performs a dynamic simulation operation based on the drug administration parameters to generate power output parameters and motion control parameters required for the jet to penetrate the skin; S103: performing electromagnetic simulation calculation according to the power output parameters to generate and output at least one set of structural parameters and electrical parameters of the power drive module; S104 performs structural simulation calculation according to the power output parameters and motion control parameters to generate at least one set of container structural parameters of the drug container module, and executes step S105; S105: obtaining a preset skin mechanics model corresponding to the drug administration parameters; based on the preset skin mechanics model, performing fluid mechanics simulation according to the motion control parameters and the container structure parameters to simulate the drug diffusion state during the injection process; when at least one drug diffusion state satisfies the preset diffusion state, outputting the corresponding container structure parameters and executing step S106; otherwise, executing step S104 to update the container structure parameters; S106 determines the design parameters of the needle-free syringe according to the output structural parameters, electrical parameters, and container structural parameters.

2. The method according to claim 1, characterized in that The method further comprises: Obtaining manufacturing process restrictions and user usage requirements of the needle-free syringe, and setting parameter boundary thresholds for parameters generated by each simulation operation based on the manufacturing process restrictions and the user usage requirements, wherein the parameter boundary thresholds include the lowest and / or highest values ​​of the parameters; When it is identified that any parameter exceeds the corresponding parameter boundary threshold, the parameter exceeding the parameter boundary threshold is removed, and / or a corresponding simulation operation is performed to update the parameter exceeding the parameter boundary threshold.

3. The method according to claim 2, characterized in that The parameter boundary threshold includes a first preset size; S103 includes: Determine the expected size of each group of the power drive module corresponding to each group according to each group of the structural parameters and the electrical parameters; If there is at least one group of expected sizes smaller than the first preset size, the corresponding structural parameters and electrical parameters are output, and step S104 is executed; otherwise, step S102 is executed to update the power output parameters and the motion control parameters.

4. The method according to claim 2, characterized in that: The parameter boundary threshold includes a preset displacement, the motion control parameter includes a displacement parameter, and S102 includes: When the displacement parameter is less than the preset displacement, re-execute step S102 to update the power output parameter and the motion control parameter; and / or, The parameter boundary threshold includes a second preset size, and the container structure parameter includes a liquid inlet size parameter; S104 includes: If at least one of the liquid inlet size parameters is smaller than the second preset size, the corresponding container structure parameters are output and step S105 is executed; otherwise, step S104 is re-executed to update the container structure parameters.

5. The method according to claim 1, characterized in that: The step S106 and above also includes: When there is only one set of the structural parameters, the electrical parameters, and the container structural parameters, the structural parameters are used as target structural parameters, the electrical parameters are used as target electrical parameters, and the container structural parameters are used as target container structural parameters; When there are at least two groups of the structural parameters and the electrical parameters, and / or when there are at least two groups of the container structural parameters, the target structural parameters, target electrical parameters, and target container structural parameters are determined according to the parameter preferred threshold, wherein the parameter preferred threshold includes the preferred value range of the parameter.

6. The method according to claim 5, characterized in that The design parameters of the needle-free syringe include: a first design parameter, a second design parameter, and a third design parameter; S106 includes: Generate the first design parameter of the power drive module according to the target structural parameter and the target electrical parameter; generating the second design parameters of the drug container module according to the target container structure parameters; The third design parameters of the remaining modules of the needle-free injector are generated based on the first design parameters and the second design parameters.

7. The method according to claim 1, characterized in that The S102 further includes: Based on a preset pressure calculation formula, the stagnation pressure threshold of the injection jet flow penetrating the skin is calculated according to the injection drug type, the injection drug dosage, and the injection object type; A dynamic simulation operation is performed according to the stagnation pressure threshold, and the required power output parameters and motion control parameters are output.

8. A simulation system for a needle-free syringe, characterized in that: The needle-free injector comprises a power drive module, a motion execution module, and a drug container module. The power drive module outputs power so that the motion execution module pushes the medicine in the drug container module to form a jet flow to penetrate the skin to complete the injection operation. The system comprises: An operation parameter module, used to obtain drug administration parameters in a needle-free injection scenario to be simulated, wherein the drug administration parameters include at least one of an injection object type, an injection drug type, and an injection drug dose; A dynamics simulation module, used for performing dynamics simulation calculation based on the drug administration parameters to generate power output parameters and motion control parameters required for the jet to penetrate the skin; An electromagnetic simulation module, used for performing electromagnetic simulation calculation according to the power output parameters, generating and outputting at least one set of structural parameters and electrical parameters of the power drive module; A structural simulation module, used for performing structural simulation calculation according to the power output parameters and motion control parameters to generate at least one set of container structural parameters of the drug container module; A fluid mechanics simulation module, used for obtaining a preset skin mechanics model corresponding to the drug administration parameters; based on the preset skin mechanics model, performing fluid mechanics simulation according to the motion control parameters and the container structure parameters to simulate the drug diffusion state during the injection process; when at least one drug diffusion state satisfies the preset diffusion state, outputting the corresponding container structure parameters; otherwise, updating the container structure parameters; The design parameter module is used to determine the design parameters of the needle-free syringe according to the output structural parameters, electrical parameters and container structural parameters.

9. A computer device, characterized in that: The computer device includes a memory and a processor; The memory is used to store computer programs; The processor is used to execute the computer program and implement the simulation method of the needle-free injector according to any one of claims 1 to 7 when executing the computer program.

10. A computer-readable storage medium, characterized in that: The computer-readable storage medium stores a computer program, and when the computer program is executed by a processor, the processor implements the simulation method of the needle-free injector according to any one of claims 1 to 7.

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