Wearable edema-damage composite skin simulation teaching model and preparation method thereof

Abstract

The invention provides a wearable edema-damage composite skin simulation teaching model and a preparation method thereof. The wearable edema-damage composite skin simulation teaching model is composed of a high-elastic silica gel skin substrate, an edema simulation layer, a lesion module, a protection layer and a fixing assembly. The multifunctional simulation skin device can be directly worn on the thighs, the shanks or the trunk, can present common clinical wounds such as edema, laceration, cutting wounds and puncture wounds of different degrees on site, and is used for skill training and examination such as puncture, debridement, suture and bandaging of nursing, surgery, emergency treatment and battlefield rescue.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of medical teaching models, and in particular relates to a wearable edema-broken composite skin simulation teaching model and a preparation method thereof. BACKGROUND

[0002] Existing skin teaching models are mostly single-layer silicone structures, which have significant defects in structural fidelity, functional diversity and operational efficiency, severely restricting the skill acquisition of students in complex and dynamic clinical situations. Traditional solutions are usually limited to simulations on disposable silicone plates, and these models cannot conform to the human body surface, resulting in a serious lack of realism and difficulty in operating practice on real limbs or trunks. In addition, traditional models cannot simultaneously present "edema + broken" composite injuries, so students cannot intuitively experience the changes in tissue tension and the differences in exudation during training. Since the model is usually fixed on the desktop, it cannot simulate the important rescue operations such as body position transfer, limb elevation or compression hemostasis. Most importantly, existing models lack quick structure replacement, resulting in the need for overall scrapping after a single training, which greatly increases the teaching cost and rotation efficiency. SUMMARY

[0003] The present application aims to overcome the technical defects of existing skin teaching models and provide a lightweight, wearable, modular high-fidelity skin device to meet the teaching needs of composite wound assessment and treatment in dynamic environments. Specifically, a multifunctional simulation skin device that can be directly worn on the thigh, calf or trunk can present different degrees of edema, laceration, incised wound, puncture wound and other clinically common wounds, and is used for skill training and assessment of puncture, debridement, suture, bandaging and other skills in nursing, surgery, emergency and field rescue.

[0004] To achieve the above-mentioned purpose, the technical solutions of the present application are as follows:

[0005] I. Structure

[0006] The wearable edema-broken composite skin simulation teaching model provided by the present application is composed of a high-elasticity silicone skin base, an edema simulation layer, a lesion module, a protective layer and a fixing assembly. The preferred technical solutions of each component are as follows:

[0007] (1) High-elasticity silicone skin base

[0008] The high-elasticity silicone skin base is used as a support, and fluid pipelines and a quick-plug installation window are pre-set inside. A micro peristaltic pump and a liquid storage bag are externally hung on the base and connected with the free ends of the fluid pipelines, which can output simulated blood or clear exudate at a set flow rate, realize full-process training such as puncture and liquid extraction, incision and pressure reduction, hemostasis and suture, and the same base can be recycled and worn on multiple sites to meet the high-simulation and high-efficiency requirements of clinical rescue and nursing teaching. The quick-plug installation window is used for quick installation of a dynamic edema simulation layer and / or a lesion module.

[0009] Further, in order to realize support and repeated use, the high-elasticity silicone skin base is constructed by a secondary molding process. First, a transparent base layer is formed by layer-by-layer pouring of silicone, and then a skin-color silicone layer is superimposed thereon, and non-woven fabric material is used for reinforcement to enhance the ductility and strength of the skin base.

[0010] Further, a quick-plug interface and a magnetic attraction array are arranged on the quick-plug installation window. The quick-plug interface is used for docking with the liquid inlet of the dynamic edema simulation layer and the lesion module, and the flow of simulated blood or tissue fluid is realized under the control of the control pump; and the magnetic attraction array is used for magnetic attraction and fixation of the dynamic edema simulation layer and the lesion module.

[0011] (2) Edema simulation layer

[0012] The edema simulation layer is located below the high-elasticity silicone skin base and includes static and dynamic edema simulation layers, which are specifically as follows:

[0013] (i) The static edema simulation layer includes an edema layer and an exudate layer. The edema layer is obtained by reacting components in the following proportions: 1 part of a base silicone polymer, 3 parts of a viscosity / touch feeling adjuster, and 4 to 9 parts of a porosity / density adjuster, which can be varied. Further preferably, the base silicone polymer is selected from Platsil 10 silicone, the viscosity / touch feeling adjuster is selected from PDMS silicone oil, peanut oil or IPM, and the porosity / density adjuster is selected from hollow microspheres or fumed silica.

[0014] With the increase of the proportion of component 3, the density and mechanical resistance (Shore hardness) of the tissue increase, and the rebound speed after pressure significantly slows down. This change accurately simulates the physical properties of the transition from acute, watery edema (low proportion, fast rebound) to chronic, fibrotic, tough edema (high proportion, slow rebound, i.e. IV degree or more severe edema) in clinical practice. This enables baseline presetting of the degree of edema at the manufacturing stage by simply adjusting the proportion of the formula.

[0015] The exudate layer is a foaming material, using polyurethane as the core reaction raw material, stannous octoate as the catalyst, to generate a basic foaming material structure with a pore size range of 50-300 microns, then after the foaming material structure is formed and solidified, saturated adsorption is completed by immersing in an oily liquid with a viscosity of 1000 mPa·s.

[0016] Further preferably, the mass ratio between the polyurethane stock solution and the catalyst stannous octoate is 1:2.3.

[0017] According to the training needs, the infiltrating oily liquid can simulate different clinical body fluids by dyeing: for example, immersion in a yellow liquid can simulate serum or tissue exudate; immersion in a red liquid can simulate blood.

[0018] (ii) The dynamic edema simulation layer includes porous tissue and an adjustable pressure water sac. The porous tissue is obtained by fusion reaction of the following components in parts by weight: 1 part of basic silica gel polymer, 3 parts of viscosity / touch feeling adjuster; preferably, the basic silica gel polymer is selected from Plastone No. 10 silica gel, the viscosity / touch feeling adjuster is selected from PDMS silicone oil, peanut oil or IPM, and the porosity / density adjuster is selected from hollow microspheres or fumed silica, to achieve simulation of subcutaneous fat soft tissue.

[0019] The adjustable pressure water sac is installed in the quick plug installation window and connected to an externally hung micro peristaltic pump and liquid storage bag system, the sac wall is made of high-elasticity and high-durability film material, can withstand continuous pressure cycling and puncture operation, and is provided with a pressure monitoring system.

[0020] Further preferably, the sac wall of the adjustable pressure water sac is made of Plastone No. 10 silica gel, the interface between the liquid inlet and the quick plug installation window is sealed and connected by a sealing gasket, and a magnet is further arranged on the sac wall; this arrangement not only enables the water sac to withstand pressure cycling and puncture operation, but also enables the water sac to be fixedly connected with the high-elasticity silica gel skin substrate, and prevents leakage of simulated tissue fluid during pressure adjustment.

[0021] The pressure monitoring system includes a pressure sensor or a pressure detector, which monitors the operating pressure of 5 mmHg to 35 mmHg. This pressure range can achieve comprehensive simulation of 0-IV degree edema, covering complete edema and high tissue tension states encountered in clinical practice.

[0022] (3) Lesion module

[0023] The lesion module includes cutting, puncturing, avulsion, and complex edema-broken configurations, and is internally embedded with microvessels / exudate tubes, which can be disassembled and assembled within 10 seconds through the quick plug interface and the standard window on the surface of the substrate.

[0024] Further, the size of the lesion module ranges from 10×10 cm to 40×40 cm to meet the size requirements of different simulated skin parts.

[0025] (4) Protective layer and fixing components

[0026] The protective layer is located below the edema simulation layer and the lesion module, serving as a protective barrier to prevent leakage of fluid from the adjustable pressure water bag and the lesion module from the bottom.

[0027] Preferably, the protective layer is a simulated muscle layer, prepared from a platinum vulcanized silicone rubber thermosetting material or by adding an appropriate amount of color powder; the high-elastic silicone skin base and the protective layer are fixedly connected by an adhesive method.

[0028] The fastening components are used to enable the model to be worn, including flexible straps or vest-style fasteners. Flexible straps are used for wearing skin models of the arms or legs, with two corresponding flexible straps on the left and right sides symmetrically equipped with Velcro snaps; vest-style fasteners are used for wearing skin models of the torso.

[0029] II. Preparation Method

[0030] (1) Substrate preparation and mold forming

[0031] During the substrate preparation and mold forming stages, a level operating platform calibrated with a spirit level is selected, and raw materials and tools are placed in an orderly manner to ensure the stability of the entire operation. Depending on the requirements of the vest or strap structure, a frame is constructed using sheet material or a mold frame. A transparent base layer is formed by pouring silicone layer by layer, and a skin-colored silicone layer is then layered on top, reinforced with non-woven fabric to enhance the elasticity and strength of the skin base. Subsequently, a foam structure is added below the base layer to form a soft tissue layer with slow rebound properties. This layer effectively simulates the pressure cushioning effect of edema tissue in the human body, making the overall feel closer to real clinical manifestations.

[0032] The first component, silicone (a transparent base layer), is poured and partially cured. During this stage, the fluid lines connecting the water bladder and the quick-connect installation window are precisely embedded, ensuring the lines are accurately positioned at the pre-drilled interface locations. On top of the cured base layer, skin-colored silicone is used for secondary molding, forming an outer skin layer with high toughness and fine texture. During the skin layer curing process, non-woven fabric is layered inside the silicone for reinforcement, significantly improving the skin base's elongation and tear resistance, ensuring the substrate's cycle life.

[0033] Preferably, the base silicone polymer (Puston No. 10 silicone), curing agent (fumed silica) and silicone oil are fully blended at a mass ratio of 10:1:10, poured into a cleaned mold and partially cured, precisely embedding the fluid pipeline and quick-connect installation window; then, skin-colored silicone is used for secondary molding on the cured base layer.

[0034] (2) Edema simulation and functional construction

[0035] In terms of edema simulation and functional construction, it is divided into two parts: static edema simulation and dynamic edema simulation, as detailed below:

[0036] (i) Construction of static edema simulation layer

[0037] One part of base silicone polymer (Puston No. 10 silicone), three parts of viscosity / touch modifier (PDMS silicone oil, peanut oil or IPM), and four to nine parts of porosity / density modifier (hollow microspheres or fumed silica) are fully fused together and placed on the inner side of the substrate layer to cure naturally, forming a soft tissue edema simulation layer of different degrees.

[0038] Subsequently, using the aforementioned polyurethane as the core reaction raw material and stannous octoate as the catalyst, a basic foam material structure with a pore size range of 50-300 micrometers is generated. After the foam material structure is formed and cured, it is saturated and adsorbed by wetting an oily liquid with a viscosity of 1000 mPa·s to serve as an exudate layer. This layer is then attached to or placed within the soft tissue edema simulation layer to simulate different clinical body fluid exudations.

[0039] (ii) Construction of dynamic edema simulation layer

[0040] This invention features a standard window pre-drilled on the substrate surface, connected to an internal adjustable pressure water bladder. This bladder uses an external micro-peristaltic pump and reservoir bag for fluid injection and tension adjustment, dynamically representing different grades of pitting edema from 0 to IV. Trainees can intuitively feel the differences in tissue tension and rebound through palpation or pressure during operation, further enhancing the clinical realism of the teaching. A porous soft tissue layer with slow rebound characteristics is formed through a foaming process. By adjusting the proportions, baseline presets for tissue stiffness and edema degree are achieved. Specifically: One part of the base silicone polymer (Puston No. 10 silicone), three parts of viscosity / touch modifier (PDMS silicone oil, peanut oil, or IPM), and a porosity / density modifier (hollow microspheres or fumed silica) are fully blended to simulate subcutaneous fat soft tissue. The adjustable pressure water bag is then installed in the quick-connect installation window and connected to the external miniature peristaltic pump and reservoir bag system. The bag wall is made of a highly elastic and durable thin film material, which can withstand continuous pressure cycles and puncture operations, and is equipped with a pressure monitoring system.

[0041] (3) Pathogen module design and quick-assembly structure

[0042] The design of the lesion modules combines magnetic fixation with quick-connect interfaces, enabling modules to be assembled and disassembled within 10 seconds, making the replacement process highly efficient and convenient. The modules come in various forms, including modules for lacerations, punctures, avulsions, and complex edema-rupture injuries, all of which embed microvessels and exudation channels, allowing connection to a fluid storage system to simulate bleeding or tissue exudation. In this way, trainees can not only perform procedures such as puncture and aspiration, incision and decompression, hemostasis and suturing, and pressure bandaging, but also conduct comprehensive training on complex trauma cases based on different module combinations.

[0043] The outer shell of the lesion module can be manufactured using 3D printing technology to ensure high dimensional accuracy and structural stability to support magnetic fixation and alignment of the fluid interface. 3D printing can produce a robust and dimensionally accurate module shell, ensuring the reliability of the interface during repeated use and rapid replacement (within 10 seconds), while also facilitating the embedding of magnetic elements at the module edges.

[0044] The module incorporates embedded microvascular / exudation channels connected to quick-connect interfaces. These channels can be pre-programmed according to the type of trauma (cutting, puncture, etc.). The microfluidic channel is also fabricated using 3D printing technology: complex and precise microvascular channels, especially those simulating different types of trauma pathways, can be directly integrated into the module using high-resolution 3D printing technology, ensuring accurate fluid control.

[0045] (4) Wearable structure and safety design

[0046] To ensure wearability and adaptability to various body parts, this invention incorporates two base forms: flexible straps and a vest. The thigh or calf straps utilize a Velcro structure approximately 70 cm long, suitable for leg circumferences of 35–65 cm, ensuring a secure and snug fit during training. The vest features symmetrical windows at the chest, shoulder blades, and sides, supporting multi-point or symmetrical training to improve teaching efficiency. Furthermore, all straps are equipped with emergency quick-release buckles, allowing the device to be quickly released within one second in emergencies, significantly enhancing safety during training.

[0047] (5) Demolding and Inspection

[0048] During the demolding and inspection phase, the frame is removed after each layer of the structure has cured, resulting in a complete wearable training module. Subsequently, the smoothness of the skin base, the elasticity of the foam layer, the sealing of the water bladder, and the magnetic adhesion of the disease module are confirmed through visual inspection, structural pull test, liquid injection test, and actual wearing experience.

[0049] The beneficial protections and technical effects of this invention are as follows:

[0050] Through the above technical solution, the present invention achieves the following four objectives and overcomes many defects of the current single-layer silicone simulated skin structure, as detailed below:

[0051] High-fidelity edema simulation: Enables dynamic simulation of grade 0 to grade IV pitting edema and tension blisters in clinical practice, and supports a full range of procedures such as puncture and aspiration, and incision and decompression.

[0052] Complex wound support: It can simulate various single or complex wounds such as lacerations, tears, avulsions, and punctures, and supports the complete training process from hemostasis and debridement to suturing and bandaging.

[0053] Highly efficient modular structure: Through innovative design, the lesion module can be quickly replaced within 10 seconds, greatly improving the efficiency of teaching rotation and ensuring that the skin base is washable and reusable.

[0054] Multi-body wear adaptability: The device is designed to fit multiple body parts such as the thigh, calf, upper arm and torso, with adjustable tightness, and can be worn close to the body. It supports training in dynamic and non-fixed environments, and is especially suitable for emergency and battlefield medical scenarios that require high durability and rapid response. Attached Figure Description

[0055] Figure 1 The image shows a physical diagram of the wearable edema-damaged composite skin simulation teaching model of the present invention;

[0056] Figure 2 The image shows the wearable edema-damaged composite skin simulation teaching model of the present invention on the lower leg;

[0057] Figure 3 A physical image of the exudate layer in the edema simulation layer of the present invention is shown. Detailed Implementation

[0058] The following embodiments further illustrate the present invention and should not be construed as limiting the invention. The embodiments do not include a detailed description of conventional methods, which are well known to those skilled in the art and described in numerous publications.

[0059] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as are familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention, and the preferred embodiments and materials described in the specific implementation are for illustrative purposes only.

[0060] Unless otherwise specified, the experimental methods described in the following examples are generally performed under standard conditions or as recommended by the manufacturer.

[0061] Example 1: Construction of a Wearable Edema-Damaged Composite Skin Simulation Teaching Model

[0062] 1. Adjustable formulation multilayer composite material system

[0063] The core technology of this invention lies in its multilayer composite material system, especially in achieving high simulation of tissue tension and resilience characteristics through precise formulation adjustment.

[0064] 1.1 Matrix Structure and Construction

[0065] (i) Structural layering and function

[0066] Skin layer (epidermis): Provides a realistic visual and tactile experience. This invention employs a two-stage molding process to create the outer skin layer. This not only improves the precision of the simulation, but more importantly, the two-stage molding process enhances the density and toughness of the skin layer, enabling it to provide robust protection for the underlying edema layer and porous structure, thus extending the lifespan of the device.

[0067] Reinforcing layer: A non-woven fabric material is layered on top of the silicone base layer for reinforcement, significantly improving the extensibility and tear resistance of the skin base. This structural design is key to enabling the reusability of the same base layer, ensuring that the base layer will not be damaged by tissue pulling during repeated punctures, sutures, and other procedures.

[0068] Muscle Layer / Protective Layer: According to the invention concept, the underlying muscle layer is designed to be relatively thin, and its main function is to act as the last protective barrier for the edema layer, preventing leakage of fluid sacs or exudate from the bottom. This layer is required to be highly flexible and have excellent puncture resistance.

[0069] (ii) Construction method

[0070] Silicone base layer and reinforcing layer fusion: The base silicone polymer (Puston No. 10 silicone), curing agent (fumed silica), and silicone oil are fully fused at a mass ratio of 10:1:10, then poured into a cleaned mold and partially cured. During this stage, the fluid lines connecting the water bladder and the quick-connect installation window are precisely embedded, ensuring the pipe ports are accurately positioned at the pre-reserved interface locations. On top of the cured base layer, skin-colored silicone is used for secondary molding to form an outer skin layer with high toughness and fine texture. During the skin layer curing process, non-woven fabric is layered inside the silicone for reinforcement, significantly improving the extensibility and tear resistance of the skin base and ensuring the cyclic service life of the substrate.

[0071] Muscle layer / protective layer: The protective layer is a simulated muscle layer, prepared from platinum vulcanized silicone rubber thermosetting material or with the addition of 1% color powder; the high-elastic silicone skin base is fixedly connected to the protective layer by an adhesive method.

[0072] 1.2 Static Edema Simulation Layer: Foaming Materials and Infiltration Mechanism

[0073] The core of edema layer simulation lies in the use of a foamed gel structure to form a soft tissue layer with slow rebound properties. This slow rebound property is the physical basis for simulating clinical pitting edema, effectively mimicking the cushioning effect of real edema tissue slowly recovering after pressure. Specifically:

[0074] (i) Porous structure and liquid wetting:

[0075] To simulate the exudation of tissue fluid and blood, the foamed material needs to possess high and interconnected porosity (preferably with a pore size range of 50-300 micrometers). This porous structure, after molding and curing, is saturated by impregnation with an oily liquid with a viscosity of 1000 mPa·s. The oily liquid (such as a high-viscosity silicone oil mixture) is chosen as the matrix for simulating body fluids because its non-volatile and controllable viscosity ensures the stability of the simulated body fluids within the pores and allows for controlled-rate exudation when the structure is cut or punctured. Depending on training requirements, the impregnation liquid can be stained to simulate different clinical body fluids: for example, impregnation with a yellow liquid simulates serum or tissue exudate; impregnation with a red liquid simulates blood. See the physical image. Figure 3 .

[0076] Specifically, the foam material uses polyurethane as the core reactant, generating its basic structure through a chemical reaction. Simultaneously, stannous octoate is used as a catalyst, which on one hand promotes molecular chain growth, ensuring the formation of a stable polymer skeleton; on the other hand, the large amount of CO2 gas generated during the reaction naturally forms a porous structure within the material, ultimately resulting in a highly elastic foam material. This composition and preparation system is the core of achieving both "slow rebound characteristics" and "porous liquid permeation function," simultaneously meeting the needs of tactile simulation and training operations.

[0077] The outer skin layer (achieved through secondary molding) plays a crucial sealing role in this mechanism, preventing the liquid matrix from leaking out of the gaps when not in operation, thereby maintaining the cleanliness and functionality of the equipment.

[0078] (ii) Static edema simulation

[0079] A key innovation of this invention lies in the adjustable parameters of the edema layer formulation, particularly the use of various mixed silicone materials, which allows for the preparation of simulated tissues with different mechanical properties to mimic edema of varying degrees and causes. The application of different ratios, ranging from 1:3:4 to 1:3:9, is not merely a matter of simple process parameters, but rather a precise control over the material's density, stiffness, and rebound rate.

[0080] The formula can be broken down into three key ingredients:

[0081] Component 1 (1 part, fixed): Silicone base polymer (Puston No. 10 silicone).

[0082] Component 2 (3 parts, fixed): viscosity / touch modifier (e.g., PDMS silicone oil or softener) to control the overall softness of the material and mimic the feel of the subcutaneous fat layer.

[0083] Component 3 (4 to 9 parts, variable): Porosity / density modifier (hollow microspheres or fumed silica), which directly controls the pore volume, density and stiffness of the material, and thus determines its slow rebound behavior.

[0084] As the proportion of component 3 increases (from 4 parts to 9 parts), the density and mechanical resistance (Shore hardness) of the tissue increase accordingly, and the rebound speed after compression decreases significantly. This change precisely simulates the physical characteristics of the clinical transition from acute, edematous edema (low proportion, fast rebound) to chronic, fibrotic, tough edema (high proportion, slow rebound, i.e., grade IV or more severe edema). This allows for baseline pre-setting of the degree of edema during the manufacturing process simply by adjusting the formulation proportions.

[0085] 1.3 Dynamic Edema Control System

[0086] Another key innovation of this invention lies in its dynamic control system, which can elevate edema simulation from static material properties to a precisely adjustable dynamic function with clinically quantifiable standards.

[0087] (i) Adjustable pressure water bladder design and pressure feedback mechanism

[0088] The device integrates an adjustable pressure water bladder, which is connected to an external miniature peristaltic pump and a reservoir bag system. By precisely controlling the injection and extraction of liquid, the system can dynamically adjust the hydraulic tension inside the water bladder, thereby applying pressure to the multi-layered simulated skin structure above, simulating real tissue tension changes.

[0089] The water-filled bladder must be made of a highly elastic and durable thin-film material (Puston 10 silicone) and placed beneath the composite silicone / porous tissue layer. Its design must be able to withstand continuous pressure cycles and puncture procedures, which is crucial for enabling the recycling of the basal structure.

[0090] Clinical stress calibration:

[0091] To achieve accurate medical teaching, the system correlates measurable internal pressure (mmHg) with clinical edema grading. For example, the device can be set to a pressure of 20 mmHg. This pressure level is used to simulate the initial pressure reading for severe pitting edema (Grade III / IV) or potential compartment syndrome. When combined with an integrated pressure sensor, objective, quantifiable, and clinically calibrated training feedback can be provided, resulting in training effectiveness far superior to models relying solely on qualitative tactile sensation. This invention enables comprehensive simulation of edema from grade 0–IV, typically corresponding to an operating pressure range of 5 mmHg to 35 mmHg, to cover complete edema and tissue hypertension conditions encountered clinically.

[0092] (ii) Construction

[0093] The composite silicone / porous tissue layer comprises the skin layer and subcutaneous adipose tissue layer. One part of the base silicone polymer (Puston 10 silicone), three parts of viscosity / touch modifier (PDMS silicone oil, peanut oil, or IPM), and a porosity / density modifier (hollow microspheres or fumed silica) are fully blended to simulate subcutaneous adipose tissue. An adjustable pressure water bag is then installed within a quick-connect window and connected to an external micro-peristaltic pump and reservoir system. The bag wall is made of a highly elastic and durable thin film material, capable of withstanding continuous pressure cycles and puncture procedures, and is equipped with a pressure monitoring system.

[0094] 1.4 Composite Trauma Module and Microfluidic Interface

[0095] The advantage of this invention lies in its integration of dynamic hydraulic pressure (edema) with a pathological module (wound). The pressure applied by the water bladder increases the stiffness and resistance of the underlying porous tissue, simulating the increased hydrostatic pressure in edematous tissue.

[0096] Microfluidic system integration: Microvessels or exudative channels are embedded within the lesion module. These channels connect to standard windows on the substrate surface via quick-connect interfaces, thereby communicating with external peristaltic pumps and reservoir systems.

[0097] Bleeding simulation: The peristaltic pump can output simulated blood at a set flow rate (e.g., 1 mL / min) to achieve dynamic bleeding, requiring trainees to perform compression hemostasis and suturing operations.

[0098] Puncture / Aspiration: The water-filled balloon itself serves as a reservoir for fluid storage during puncture and aspiration. After puncture, the trainee can observe fluid backflow. After aspirating 5-20 mL of fluid, the pressure in the water-filled balloon decreases, and the recovery of tissue depression can be observed, simulating the entire process of incision decompression or puncture drainage.

[0099] 2. Packaging and sealing technology

[0100] In quick-change structures, airtightness is crucial for ensuring the integrity of the system's fluid flow. Because the internal water bladder generates localized pressures up to 20 mmHg when simulating severe edema, the connection between the module and the skin substrate must be reliably sealed. Precision sealing gaskets (such as silicone O-rings) are selected at the standard window on the substrate surface. When the lesion module is secured in place by magnetic attraction, sufficient compressive force must be provided to tighten the sealing ring, ensuring that the quick-connect fluid interface does not leak under pressure.

[0101] 3. Modular and wearable architecture

[0102] The present invention emphasizes modularity, quick replacement and ergonomic adaptability in structural design to meet the needs of efficient teaching and dynamic training.

[0103] 3.1 Quick-release lesion module structure and magnetic design

[0104] The lesion module adopts a structure combining magnetic fixation and quick-connect interface. This design aims to enable the module to be disassembled and replaced within 10 seconds, greatly shortening the preparation time between training rounds and effectively solving the problem of low efficiency in traditional models.

[0105] Magnetic attraction systems (e.g., using neodymium magnet arrays) must have self-alignment capabilities to ensure accurate docking of the microfluidic quick-connect interface during rapid module placement, while simultaneously providing sufficient attraction to maintain module stability and compress the sealing gasket. Modules are available in various forms, covering laceration, puncture, avulsion, and complex edema-rupture modules, each with an independently embedded microfluidic pathway.

[0106] The modules are highly flexible and customizable in size, ranging from 10×10 cm to 40×40 cm, and can be cut or installed in different positions on the body as needed.

[0107] 3.2 Wearable substrate and multi-site adaptability

[0108] To support the entire rescue process, including dynamic operations such as elevation, compression, and transfer, the wearability of the equipment is placed at the core.

[0109] Matrix form and adaptability:

[0110] Flexible straps: Suitable for the thighs and calves, featuring an approximately 70cm long Velcro structure with adjustable tightness to fit leg circumferences of 35–65cm. Ensures a secure fit during training and prevents shifting. See details. Figure 2 .

[0111] Vest base: Suitable for the torso, with symmetrical windows at the chest, shoulder blades and sides to support multi-point or symmetrical training and improve teaching efficiency.

[0112] Surface adaptability: The skin base uses high-elastic silicone and non-woven fabric reinforcement layers to ensure the flexibility and extensibility of the material, so that it is not limited to regular shapes, but can fit any curved surface, overcoming the defect of traditional models that cannot fit the curved surface of the human body.

[0113] Safety design: All straps are equipped with emergency quick-release buckles to ensure that the device can be quickly released within 1 second in an emergency, which significantly improves safety during training, especially when simulating high-pressure emergency rescue scenarios.

[0114] 3.3 Application of 3D Printing Technology in Modularization

[0115] This invention employs a hybrid manufacturing strategy, combining traditional silicone casting with advanced 3D printing technology to improve the precision and customization capabilities of the modules.

[0116] 3D printing technology is key to achieving modularity and surface adaptability:

[0117] Custom molds and surface molding: 3D printing can be used to quickly create precise molds for non-standard anatomical parts (such as body curves) and guide the layer-by-layer pouring of silicone.

[0118] Rigid Modular Housing: The housing of modular components requires high dimensional precision and structural stability to support magnetic attachment and alignment of fluid interfaces. 3D printing can produce robust and dimensionally accurate modular housings, ensuring interface reliability during repeated use and rapid replacement (within 10 seconds).

[0119] Microfluidic channel fabrication: Complex and precise microvascular channels, especially those used to simulate different types of trauma, can be directly integrated into the module using high-resolution 3D printing technology, ensuring the accuracy of fluid control.

[0120] Application Example 1: Simulation of Combined Wound Incision and Decompression with Fluid Exudation

[0121] This embodiment focuses on demonstrating the porous structure and layered liquid exudation function of the foamed material.

[0122] Material preparation: The prefabricated module uses a slow rebound foamed silicone (simulating moderately edematous fibrotic tissue) formulated with a silicone base polymer, viscosity / touch modifier, and porosity / density modifier in a 1:3:6 ratio. This foamed layer has been infiltrated with a saturated yellow oily liquid (simulating tissue exudate).

[0123] Operating procedure: The trainee cuts open and decompresses a module containing the foam layer. When the trainee cuts open the superficial layer of skin and foam layer, a yellow oily liquid can be seen slowly seeping out from the cut edges and wound surface, simulating the leakage of tissue fluid after edema is cut. Figure 3 ).

[0124] Deep cutting simulates blood: Trainees then perform deep debridement. A red fluid line connected to a peristaltic pump is pre-embedded beneath this module. When the cut reaches a preset deep "blood vessel" area, the peristaltic pump activates, and red fluid (simulated blood) begins to flow dynamically at a set rate (e.g., 0.5 mL / min), requiring trainees to immediately perform hemostasis and suturing. Figure 3 This embodiment verifies the ability of porous structures to dynamically simulate controlled fluid exudation and layered trauma.

[0125] Application Example 2: Suturing Training for Cuts with Bleeding

[0126] This embodiment verifies the rapid module replacement and active bleeding simulation functions.

[0127] Setup and Startup: Embed a pre-fabricated 6 cm long full-thickness laceration module. Connect to the reservoir via the quick-connect interface, start the peristaltic pump, and set the simulated bleeding flow rate to 1 mL / min.

[0128] First aid procedures: Trainees must complete the first aid according to the standard procedure: apply pressure to the bleeding point to stop the bleeding; clean the wound; suture in layers; apply pressure bandage.

[0129] Teaching efficiency: After the operation is completed, the trainee only needs to lift the edge of the module with their thumb, and the magnetic structure will immediately detach. The new disease module can be in place within 10 seconds, achieving extremely high teaching turnover efficiency.

[0130] Application Example 3: Application of 3D Printed Custom Surface Modules in Shoulder Joint Trauma Training

[0131] This embodiment demonstrates the adaptability of the invention to complex anatomical sites (curved surfaces) and its modular manufacturing capabilities.

[0132] Customized design and manufacturing: For complex curved surfaces such as the shoulder and elbow joints, the design is first obtained through 3D scanning.

[0133] Obtain the surface data of the target area. Use 3D printing technology to precisely manufacture a module shell and silicone casting mold that perfectly fit the surface. The module size is customized to an irregular curved surface of 15×20 cm.

[0134] Installation and Wearing: The customized module is attached to the shoulder window of the wearable vest base via a magnetic quick-release structure. The curved design of the module ensures a close fit between the model and the body during student movement or operation, avoiding the unrealistic feel of traditional flat models on curved surfaces and meeting the requirements of various body parts.

[0135] Training Application: Trainees perform debridement and suturing of avulsion injuries on the shoulder module in dynamic states (such as simulated patient transfer). The stability of the module and the conformity of the curved surface ensure the authenticity and effectiveness of the operation, enabling training on any regular shape and curved surface.

[0136] The undescribed parts of this invention are the same as or implemented using existing technology. The applicant declares that this invention is illustrated through the above embodiments, but the invention is not limited to the above detailed methods, i.e., it does not mean that the invention must rely on the above detailed methods to be implemented. Those skilled in the art should understand that any improvements to this invention, equivalent substitutions of raw materials for the product of this invention, additions of auxiliary components, and selection of specific methods all fall within the protection and disclosure scope of this invention.

Claims

1. A wearable edema-damaged composite skin simulation teaching model, characterized in that, This includes a highly elastic silicone skin base, an edema simulation layer, a lesion module, a protective layer, and fixation components. The high-elastic silicone skin base is pre-installed with fluid conduits and quick-connect installation windows. The free end of the fluid conduits is connected to a control pump outside the model. The quick-connect installation windows are used to quickly install dynamic edema simulation layers and / or lesion modules. The edema simulation layer is located below the high-elasticity silicone skin base and includes two forms: a static edema simulation layer and a dynamic edema simulation layer. The lesion module includes a cutting, puncture, avulsion, and complex edema-rupture configuration, with embedded microvessels and exudation tubes; The protective layer is located below the edema simulation layer and the lesion module, serving as a protective barrier; The fixing component is used to make the model wearable.

2. The wearable edema-damage composite skin simulation teaching model according to claim 1, characterized in that, The high-elastic silicone skin base is constructed using a two-stage molding process. First, a transparent base layer is formed by pouring silicone layer by layer. Then, a skin-colored silicone layer is layered on top of this base and reinforced with non-woven fabric to enhance the elasticity and strength of the skin base. The quick-connect installation window is equipped with a magnetic array.

3. The wearable edema-damage composite skin simulation teaching model according to claim 1, characterized in that, The static edema simulation layer includes an edema layer and an exudate layer. The edema layer is obtained by fusing and reacting the following components in parts by weight: 1 part base silicone polymer, 3 parts viscosity / touch modifier, and 4 to 9 parts porosity / density modifier (variable). The permeation layer is a foamed material, using polyurethane as the core reaction raw material and stannous octoate as the catalyst to generate a basic foamed material structure with a pore size range of 50-300 micrometers. After the foamed material structure is formed and cured, it is saturated by wetting an oily liquid with a viscosity of 1000 mPa·s.

4. The wearable edema-damage composite skin simulation teaching model according to claim 1, characterized in that, in, The dynamic edema simulation layer includes a porous tissue and an adjustable pressure water bladder. The porous tissue is obtained by fusing the following components in parts by weight: 1 part of basic silicone polymer and 3 parts of viscosity / touch modifier. The adjustable pressure water bladder is installed in the quick-connect installation window and connected to the external micro peristaltic pump and liquid storage bag system. The bladder wall is made of a highly elastic and durable thin film material and is equipped with a pressure monitoring system.

5. The wearable edema-damage composite skin simulation teaching model according to claim 3, characterized in that, in, The base silicone polymer is selected from Priston No. 10 silicone, the viscosity / touch modifier is selected from PDMS silicone oil, peanut oil or IPM, and the porosity / density modifier is selected from hollow microspheres or fumed silica. The mass ratio between the polyurethane stock solution and the catalyst stannous octoate is 1:2.3; The oily liquid contains added color.

6. The wearable edema-damage composite skin simulation teaching model according to claim 4, characterized in that, in, The adjustable pressure water bladder has a wall made of Putston No. 10 silicone. The interface between the liquid inlet and the quick-connect installation window is sealed by a sealing gasket. Magnets are also provided on the bladder wall. The pressure monitoring system includes a pressure sensor or pressure detector that monitors operating pressures from 5 mmHg to 35 mmHg.

7. The wearable edema-damage composite skin simulation teaching model according to claim 1, characterized in that, in, The lesion module is made using 3D printing technology and has microvessels or exudation channels embedded inside. These channels are connected to the quick-connect installation window via quick-connect interfaces, and magnets that can be magnetically connected to the quick-connect installation window are provided on the outside of the wall. The size of the lesion module ranges from 10×10 cm to 40×40 cm.

8. The wearable edema-damage composite skin simulation teaching model according to claim 1, characterized in that, in, The protective layer is a simulated muscle layer, which is prepared from platinum vulcanized silicone rubber thermosetting material or by adding an appropriate amount of color powder; The high-elastic silicone skin base and the protective layer are fixedly connected by an adhesive method; The fixing component includes flexible straps or a vest-like form, with two corresponding flexible straps on the left and right sides symmetrically equipped with Velcro snaps.

9. The method for preparing the wearable edema-damage composite skin simulation teaching model according to any one of claims 1 to 8, characterized in that, Includes the following steps: (1) Based on the requirements of the vest or strap structure, use boards or mold frames to build the enclosure and clean it; (2) Preparation of high elastic silicone skin base: After fully mixing the base silicone polymer, curing agent and silicone oil in a mass ratio of 10:1:10, pour it into the cleaned mold and partially cure it, and accurately embed the fluid pipeline and quick-connect installation window. Then, on the cured base layer, skin-colored silicone is used for secondary molding to form an outer skin layer with high toughness and fine texture. During the curing process, non-woven fabric material is superimposed into the silicone for reinforcement. (3) After melting the edema layer or porous tissue according to the formula, attach it to the underside of the high elastic silicone skin base and solidify it, and then install the exudate layer or adjustable pressure water bag; (4) After mixing the platinum vulcanized silicone rubber thermosetting material or adding an appropriate amount of color powder evenly, let it be laid flat naturally and left to stand in a horizontal state until it is completely cured, and then fix it to the high elastic silicone skin base.

10. The preparation method according to claim 7, characterized in that, In step (1), the cleaning method of the mold is as follows: use alcohol to thoroughly wipe the frame and surface mold to remove surface dust and grease and ensure that no impurities remain; then place the mold on a flat workbench that has been calibrated with a level to ensure that each layer of material remains uniform and stable during the molding process; In step (2), the base silicone polymer is selected from Preston No. 10 silicone, and the curing agent is selected from silica. In step (4), the amount of pigment added is 1% of the platinum vulcanized silicone rubber thermosetting material.

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