Ultrasonic imaging silicone material for simulating organs and method for preparing the same

Abstract

The application provides an ultrasonic imaging silicone material suitable for a simulator organ and a preparation method thereof. The preparation raw material of the ultrasonic imaging silicone material comprises liquid silicone, oil liquid and solid powder. The preparation method of the ultrasonic imaging silicone material comprises the following steps: S01, adding the oil liquid and the solid powder into the liquid silicone respectively, uniformly mixing and then performing defoaming treatment to obtain a silicone mixture; S02, preparing a perfusion mold, and pouring the silicone mixture into the perfusion mold; S03, allowing the silicone mixture to be cured and formed in the perfusion mold to obtain the ultrasonic imaging silicone material; and S04, removing the perfusion mold, cleaning and performing surface treatment on the ultrasonic imaging silicone material, so as to complete the preparation of the ultrasonic imaging silicone material. The ultrasonic imaging silicone material is simple to process, does not need toxic cross-linking agents, can be stably stored for a long time and has high biological safety, and has important significance for promoting the standardization development of ultrasonic medical training and equipment quality control.

Description

Technical Field

[0001] This application relates to the field of medical device simulation materials technology, and in particular to an ultrasound-enhanced silicone material suitable for simulating organs and its preparation method. Background Technology

[0002] In medical clinical training, ultrasound equipment research and development, calibration, and production quality control, suitable simulated tissues are needed to mimic the acoustics, dimensions, and internal characteristics of the human body. Currently, hydrogel materials and thermoplastic elastomers (TPEs) are the mainstream material choices for preparing ultrasound membranes. Commonly used hydrogel systems include polyvinyl alcohol, hydrogel, gelatin, chitosan, agarose, and polyacrylamide gel. Human tissues prepared using these materials can be used to achieve ultrasound. However, ultrasound membranes prepared from hydrogel materials often suffer from inconvenient storage and are prone to mold growth.

[0003] If thermoplastic elastomers (TPEs) are used to prepare ultrasonic membranes, the high-temperature melting required for their processing easily generates a large amount of white smoke. Controlling the injection molding temperature of thermoplastic elastomer granules at 170~240℃ produces pollutants such as non-methane hydrocarbons, styrene, and odorous gases, which are harmful to human health and cause environmental pollution. Furthermore, thermoplastic elastomers are difficult to use for preparing complex or delicate ultrasonic membrane structures. The preparation of thermoplastic elastomers also requires the fabrication of high-temperature resistant metal molds, increasing material processing costs and presenting disadvantages such as easily limited processing conditions and high processing risks.

[0004] Therefore, for those skilled in the art, how to design an ultrasonic imaging material that is simple to process, stable in performance, and environmentally friendly, in order to effectively solve the defects of existing materials such as complex processing, easy environmental pollution, and unstable performance, is a technical problem that urgently needs to be solved. Summary of the Invention

[0005] This invention provides an ultrasound-detectable silicone material suitable for simulating organs and its preparation method. The ultrasound-detectable silicone material is simple to process, requires no toxic cross-linking agent, can be stored stably for a long time, and has high biosafety. It is of great significance for promoting the standardization of ultrasound medical training and equipment quality control.

[0006] To achieve the above objectives, this application provides an ultrasound-detectable silicone material suitable for simulating organs, wherein the raw materials for preparing the ultrasound-detectable silicone material include: liquid silicone, oil-based liquids, and solid powders.

[0007] Optionally, the oily liquid includes at least one of white mineral oil and dimethyl silicone oil;

[0008] The solid powder includes at least one of cellulose powder, calcium carbonate powder, calcium oxalate powder, talc powder, or gypsum powder.

[0009] Optionally, the mass ratio of the oil liquid to the liquid silica gel is 0.5:1 to 3:1 by weight.

[0010] Optionally, the amount of solid powder added is 0.2% to 2% based on the total mass of the oil liquid and the liquid silica gel.

[0011] Optionally, the kinematic viscosity of the oil-based liquid is 5~100 mm. 2 / s.

[0012] To achieve the above objectives, this application also provides a method for preparing an ultrasound-detectable silicone material suitable for simulating organs, applicable to any of the ultrasound-detectable silicone materials for simulating organs described in the previous application. The preparation method includes the following steps:

[0013] S01: Add oil-based liquids and solid powders to liquid silica gel, mix them evenly, and then degas to obtain a silica gel mixture;

[0014] S02: Prepare a casting mold and inject the silicone mixture into the casting mold;

[0015] S03: The silicone mixture is cured and molded in the injection mold to obtain an ultrasonic imaging silicone material;

[0016] S04: Remove the injection mold, clean and surface-treat the ultrasonic imaging silicone material to complete the preparation of the ultrasonic imaging silicone material.

[0017] Optionally, in S01, the step of adding the solid powder to the liquid silica gel includes: pulverizing the solid material, then finely grinding the solid material, and obtaining the solid powder through a flotation process.

[0018] Optionally, in S01, the step of adding the oil liquid and the solid powder to the liquid silica gel respectively includes:

[0019] First, the solid powder is added to the oil-based liquid and stirred until homogeneous. Then, the oil-based liquid containing the solid powder is added to the liquid silica gel.

[0020] Alternatively, the oil-based liquid can be added to the liquid silica gel and stirred until homogeneous, and then the solid powder can be added to the mixture of the oil-based liquid and the liquid silica gel.

[0021] Optionally, in S02, the step of preparing the injection mold includes:

[0022] The casting mold is prepared using a photocurable material and 3D printing technology. The casting mold is then cleaned and cured by secondary heating. A protective layer is then coated on the surface of the casting mold.

[0023] Optionally, in S02, the step of injecting the silicone mixture into the injection mold includes:

[0024] The silica gel mixture is injected into the injection mold under pressure, and then degassing is performed under vacuum.

[0025] Optionally, in S03, the step of curing the silicone mixture in the injection mold to obtain the ultrasonic imaging silicone material includes:

[0026] The silicone mixture is cured and shaped at low temperature using a stepped heating method to obtain the ultrasonic imaging silicone material.

[0027] This application provides an ultrasound-detectable silicone material suitable for simulating organs and its preparation method. The ultrasound-detectable silicone material uses liquid silicone as the raw material, and oil-based liquids are added to the liquid silicone to modify it, solving the problem of low penetration depth of silicone under ultrasound imaging. Simultaneously, this application also adds solid powder to the liquid silicone, which can improve the brightness of the liquid silicone under ultrasound imaging, achieving comprehensive optimization of the ultrasound imaging characteristics of the silicone material.

[0028] This silicone material is simple to process, has good dimensional stability, is easy to store, has excellent mechanical properties, stable chemical properties, can withstand high temperatures and is not easily corroded, can maintain long-term stability, has high biosafety and is environmentally friendly, and can significantly extend the service life of ultrasound imaging materials. It is of great significance for promoting the standardization of ultrasound medical training and equipment quality control. Attached Figure Description

[0029] Figure 1 This is a flowchart of a method for preparing ultrasonically developable silicone material in one embodiment of this application.

[0030] Figure 2 The images shown are ultrasonic imaging effect diagrams of two different ultrasonic imaging silicone materials in one embodiment of this application; wherein, Figure a represents the ultrasonic imaging silicone material without white mineral oil modification, and Figure b represents the ultrasonic imaging silicone material modified with white mineral oil.

[0031] Figure 3 This is a flowchart of a method for preparing an ultrasonically developable silicone material according to another embodiment of this application.

[0032] Figure 4 The image shows the ultrasonic imaging effect of nine groups of ultrasonic imaging silicone materials with different proportions of talc added, as described in one embodiment of this application. Detailed Implementation

[0033] The present application will be further described in detail below with reference to the accompanying drawings and specific embodiments. The advantages and features of the present application will become clearer from the following description. It should be noted that the drawings are all in a very simplified form and use non-precise proportions, and are only used to facilitate and clarify the illustration of the embodiments of the present application.

[0034] The terms “center,” “longitudinal,” “lateral,” “length,” “width,” “thickness,” “upper,” “lower,” “front,” “rear,” “left,” “right,” “vertical,” “horizontal,” “top,” “bottom,” “inner,” “outer,” “clockwise,” “counterclockwise,” “axial,” “radial,” and “circumferential” indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this application and simplifying the description, and do not indicate or imply that the mechanism or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this application.

[0035] It should be understood that the terms "comprising," "including," or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such a process, method, article, or apparatus. Without further limitation, an element defined by the phrase "comprising one..." does not exclude the presence of other identical elements in the process, method, article, or apparatus that includes said element.

[0036] In this application, unless otherwise expressly specified and limited, the terms "installation," "connection," "fixation," etc., should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral part; they can refer to a mechanical connection, an electrical connection, or a connection that allows communication between the components; they can refer to a direct connection or a connection through an intermediate medium; they can refer to the internal communication of two components or the interaction between two components, unless otherwise expressly limited. Those skilled in the art can understand the specific meaning of the above terms in this application according to the specific circumstances.

[0037] Traditional hydrogels are prone to losing flexibility, hardening, and even cracking due to moisture evaporation in room temperature or dry environments. Almost all hydrogels exposed to dry environments inevitably dehydrate due to moisture evaporation, leading to reduced flexibility and functionality. For example, pure water-based hydrogels rapidly lose water after being stored at room temperature for 5 days, eventually transforming into dry, blocky polymers, resulting in the failure of various properties. Furthermore, the processing of hydrogel materials is complex, and their low strength severely limits their application scenarios. Existing hydrogel-based ultrasonic membrane materials also pose varying degrees of biosafety risks. Specifically, residual monomers of polyacrylamide are potential carcinogens. Chemical crosslinking of polyvinyl alcohol (PVA) requires the use of highly toxic glutaraldehyde or epichlorohydrin.

[0038] This invention addresses the problems of existing hydrogel-type ultrasound phantoms, such as difficulty in preservation and poor dimensional stability, as well as the complex preparation process of thermoplastic elastomers and the generation of harmful gases, and the inability of traditional silicone to meet ultrasound requirements. It provides an ultrasound-developable silicone material that is simple to process, has excellent dimensional stability, requires no toxic crosslinking agents, is safe and non-toxic, can be stably preserved for a long time, has high biocompatibility, is environmentally friendly, can be industrially applied to the preparation of simulated organs, and can comprehensively optimize the ultrasound development performance of silicone materials.

[0039] The present application will now be described in detail with reference to the accompanying drawings and embodiments. Unless otherwise specified, the following embodiments and features can complement or combine with each other.

[0040] like Figures 1-3 As shown, one embodiment of this application provides an ultrasound-detectable silicone material suitable for simulating organs. The raw materials for preparing the ultrasound-detectable silicone material include: liquid silicone (e.g., PDMS polydimethylsiloxane), oil-based liquids, and solid powders.

[0041] Traditional silicone has a wide range of applications due to its excellent mechanical properties, mature processing technology, simple preparation, strong operability, good dimensional stability and stable chemical properties. It is also frequently used in the field of medical device technology. However, due to the disadvantages of traditional silicone such as low penetration depth and dark color under ultrasound imaging, traditional silicone cannot be directly used to prepare ultrasound membrane materials.

[0042] Because oil-based liquids have low attenuation, they are beneficial for sound transmission. Meanwhile, solid materials are high-density or high-modulus materials. When these materials are introduced into liquid silicone, the silicone surface can have a significant acoustic impedance mismatch interface, which can generate strong reflection and backscattering signals on the material surface, making the material exhibit obvious brightness during ultrasound.

[0043] This application uses liquid silica gel as the matrix material and introduces oil-based liquids into it to perform composite modification. This allows for the construction of a multiphase dispersion system within the silica gel material, enhancing its penetration depth under ultrasonic imaging. Simultaneously, this application adds high-density or high-modulus solid powders to the liquid silica gel, improving its brightness under ultrasonic imaging and enhancing the imaging effect of simulated tissues prepared using this ultrasonically imaging silica gel material. The oil-based liquid and solid powder fillers in this application work synergistically, utilizing a multiphase interface scattering mechanism to significantly improve the ultrasonic imaging depth while simultaneously enhancing imaging brightness, achieving comprehensive optimization of the ultrasonic imaging performance of the ultrasonically imaging silica gel material.

[0044] This silicone material is simple to process, has good dimensional stability, is easy to store, has excellent mechanical properties, stable chemical properties, can withstand high temperatures and is not easily corroded, can maintain long-term stability, has high biosafety and is environmentally friendly, and can significantly extend the service life of ultrasound imaging materials. It is of great significance for promoting the standardization of ultrasound medical training and equipment quality control.

[0045] Preferably, the oily liquid includes at least one of white mineral oil and dimethyl silicone oil. The solid powder includes at least one of cellulose powder, calcium carbonate powder, calcium oxalate powder, talc powder, or gypsum powder.

[0046] Traditional silicone has a loose, porous internal structure. This invention modifies silicone by adding medical-grade, food-grade oils such as white mineral oil and / or dimethyl silicone oil to liquid silicone. The oils have a dual effect on the ultrasonic imaging performance of silicone materials. On the one hand, the oils can reduce acoustic impedance, exacerbating the acoustic matching problem of ultrasonically imaging silicone materials; on the other hand, the oils can form microdroplets to fill the microporous structure of silicone, thereby introducing new sound propagation channels into the silicone material, reducing the acoustic attenuation coefficient, and improving the penetration depth of silicone materials under ultrasonic imaging.

[0047] More specifically, the white mineral oil and / or dimethyl silicone oil in liquid silicone can alter and regulate the material structure through three mechanisms: reducing crosslinking density, introducing microscopic phase separation structures, and changing viscoelastic properties. This forms oil droplets that fill the microporous structure of the silicone material. On one hand, liquid oil molecules interspersed between silicone molecular chains weaken the interactions between them, making the crosslinked network structure of the silicone material more porous. This reduces the overall stiffness and internal friction loss of the silicone material, and decreases energy dissipation during the propagation of ultrasound within the silicone material. On the other hand, the oil can form microscopic phase separation structures within the silicone material. Due to the limited compatibility between oil and the silicone matrix, microscopic phase separation occurs during the curing process of liquid silicone, forming uniformly dispersed droplets. These droplets fill and replace the original dense microporous structure of the silicone, changing the microstructure and pore characteristics of the silicone material. The introduction of these droplets effectively reduces the overall acoustic impedance of the material and constructs new low acoustic impedance propagation channels within the silicone matrix. This reduces the reflection loss and scattering attenuation of sound waves within the material, lowering the acoustic impedance and attenuation, and significantly improving the detection depth of the ultrasonic imaging material.

[0048] Meanwhile, to improve the brightness of liquid silicone under ultrasonic development, this invention introduces solid powder into the liquid silicone. These solid powders, as high-density or high-modulus fillers, can form a significant acoustic impedance mismatch interface in a low-density and low-acoustic impedance silicone matrix, thereby generating strong reflection and backscattering signals within the liquid silicone. This effectively overcomes the dull ultrasonic development defect caused by the "acoustic transparency" of pure silicone, and significantly improves the poor development effect of liquid silicone under ultrasonic development equipment.

[0049] Furthermore, by adjusting the proportion of solid powder added to the liquid silicone, the brightness of the ultrasonic imaging silicone material can be adjusted. By adjusting the brightness of the silicone material, the operator can highly simulate the imaging effect of different human tissues under ultrasonic imaging.

[0050] More preferably, the mass ratio of the oil liquid to the liquid silicone is 0.5:1 to 3:1, which ensures that the silicone material has sufficient penetration depth after the oil liquid is added to the liquid silicone.

[0051] Furthermore, based on the total mass of the oil-based liquid and liquid silica gel, the amount of solid powder added is 0.2% to 2%. This is because as the mass fraction of talc in the silica gel material increases, the developing ability of the modified silica gel gradually improves. However, when talc is added to a certain proportion, the increase in brightness of the silica gel material gradually plateaus and eventually reaches saturation as the amount of talc added continues to increase. Therefore, limiting the amount of solid powder added to the range of 0.2% to 2% can reduce the amount of talc added while ensuring the developing ability of the silica gel material, thereby reducing the preparation cost.

[0052] To ensure uniform dispersion of oil-based liquids in liquid silica gel, the kinematic viscosity of the oil-based liquid is preferably 5~100 mm. 2 / s.

[0053] like Figures 1-4 As shown, one embodiment of this application provides a method for preparing an ultrasound-detectable silicone material suitable for simulating organs. The method includes the following steps:

[0054] S01: Add oil-based liquids and solid powders to liquid silica gel, mix them evenly, and then defoam to obtain a mixed silica gel solution.

[0055] S02: Prepare the injection mold and inject the mixed silicone liquid into the injection mold.

[0056] S03: The silicone mixture is cured and molded in a casting mold to obtain an ultrasonic imaging silicone material.

[0057] S04: Remove the injection mold, clean and surface-treat the ultrasonic imaging silicone material to complete the preparation of the ultrasonic imaging silicone material.

[0058] This application provides a method for preparing an ultrasound-enhanced silicone material suitable for simulating organs. This preparation method is simple to process, can reduce material processing costs, and the entire preparation process does not pollute the environment, thus having high economic benefits.

[0059] When solid powder is added to liquid silica gel, due to the varying densities of the particles, larger particles tend to precipitate significantly. To address this issue, a particle size sorting process is needed to treat the solid powder added to the liquid silica gel, thereby increasing the uniformity of its dispersion and reducing precipitation.

[0060] Preferably, in S01, the steps before adding the solid powder to the liquid silica gel include: crushing the solid material (e.g., coarse crushing pretreatment), then finely grinding the solid material, and obtaining solid powder through a flotation process.

[0061] This invention employs a flotation process in the preparation of liquid silica gel. The flotation process has a significant effect on screening solid powders. By adjusting the flotation time of the solid powder, large-diameter particles in the solid powder can be screened out, improving the uniformity of the solid powder particle size, significantly improving the dispersion effect of functional particles in liquid silica gel, reducing the precipitation phenomenon of solid powder in liquid silica gel, and ensuring the imaging effect of ultrasonic materials.

[0062] In some embodiments, the solid material can be pulverized in a pulverizer. Then, a ball mill is used to ball-mill the solid material to obtain solid powder. The particle size of the ball-milled solid powder is then determined using a single-cell flotation machine to obtain small-particle solid powder. Specifically, the solid powder can be dissolved in deionized water, stirred until homogeneous, allowed to stand, and the supernatant can be extracted and dried to obtain solid powder with a smaller particle size (e.g., ultrafine talc functional mineral particles).

[0063] To ensure the uniform dispersion of solid powder particles added to liquid silicone and reduce sedimentation, thereby guaranteeing the ultrasonic development effect of the silicone material, it is preferable to remove large-diameter particles from the solid powder and improve the particle size uniformity. The above solution refines and screens the solid powder through crushing, grinding, and screening processes, thereby removing larger-diameter particles. This reduces the particle diameter of the solid powder, decreases the sedimentation ratio of solid powder in liquid silicone, optimizes the dispersion performance of solid powder in liquid silicone, and helps improve the development effect of ultrasonically developable silicone materials under ultrasonic development equipment.

[0064] Furthermore, the uniformity of the silica gel mixture is an important factor affecting the material's performance under ultrasonic imaging during preparation.

[0065] To improve the uniformity of particle dispersion in liquid silica gel and ensure the ultrasonic imaging effect of the silica gel material, as an optional solution, in step S01, the steps of adding the oil-based liquid and solid powder to the liquid silica gel separately include:

[0066] First, add the solid powder to the oil and stir until evenly mixed. Then, add the oil containing the solid powder to the liquid silica gel.

[0067] In a specific example, to achieve uniform dispersion of solid powder in liquid silicone, the base adhesive and curing agent are first mixed uniformly according to a preset ratio to obtain liquid silicone. Then, finely processed talc particles are pre-dispersed in white mineral oil. Next, the talc-containing white mineral oil liquid is added to the liquid silicone and mixed thoroughly. The resulting silicone mixture needs to undergo degassing treatment to eliminate macroscopic and microscopic bubbles. After degassing, the prepared silicone mixture is refrigerated for later use. This low-temperature static setting stabilizes the silicone mixture and slows down its curing rate, meeting subsequent pouring requirements.

[0068] For example, the defoaming treatment of the silica gel mixture can be achieved by vacuum pump suction and ultrasonic cleaning in sequence. This method can completely eliminate the bubbles in the silica gel mixture by combining negative pressure expansion and ultrasonic cavitation, and has a good defoaming effect.

[0069] As an alternative, in S01, the steps of adding the oil liquid and solid powder to the liquid silica gel separately include:

[0070] First, add the oil-based liquid to the liquid silica gel and stir until homogeneous. Then, add the solid powder to the mixture of oil-based liquid and liquid silica gel.

[0071] Furthermore, in S02, the step of preparing the injection mold includes:

[0072] The casting mold is prepared using photocurable materials through 3D printing technology. The casting mold is then cleaned and cured by secondary heating. Finally, a protective layer is coated on the surface of the casting mold.

[0073] More specifically, the present invention designs and prints the required shape of the injection mold using 3D printing technology to meet the complex and specific shape requirements of the injection mold.

[0074] Meanwhile, in order to solve the problem of catalytic deactivation caused by liquid silicone contacting the surface of the injection mold during the molding process, it is also necessary to modify the surface of the printed injection mold to form a dense protective layer on the surface of the injection mold. The protective layer can completely isolate the potentially toxic substances on the surface of the injection mold from the silicone material, ensuring that the silicone material maintains its catalytic activity during the subsequent curing process.

[0075] More specifically, this is to eliminate the inhibitory effect of residual photoinitiators (TPO, Irgacure type), unreacted monomers, and additives (amines, thiols) in the injection mold prepared by photocuring on the subsequent curing of silicone.

[0076] In one alternative example, the 3D-printed casting mold is first subjected to a combination of high-concentration alcohol immersion and ultrasonic cleaning to remove uncured material from its surface. Then, a heat treatment (i.e., secondary heat curing) promotes deep cross-linking of the resin. Following this, a specialized paint is sprayed onto the casting mold surface and air-dried at a predetermined temperature to form a continuous, dense protective coating. This protective layer physically isolates residual toxic agents, thus completely preventing the silicone material from contacting the casting mold and causing curing failure.

[0077] To ensure the smooth curing of the silicone mixture and guarantee the quality of the cured molding, a secondary degassing treatment is required for both the poured silicone mixture and the pouring mold.

[0078] As an optional embodiment, in S02, the step of injecting the silicone mixture into the injection mold includes:

[0079] The silica gel mixture is injected into the injection mold under pressure, and then degassing is performed in a vacuum environment (i.e., secondary degassing).

[0080] Because silicone generates heat during the curing process, the curing temperature must be precisely controlled to ensure the final curing effect.

[0081] In a preferred example, in step S03, the step of curing the silicone mixture within the injection mold to obtain the ultrasonic imaging silicone material includes:

[0082] The silicone mixture was cured and shaped at low temperature using a stepped heating method on the entire injection mold to obtain ultrasonically developable silicone material.

[0083] More specifically, to achieve stable and reliable curing of the silicone mixture, the prepared silicone mixture is first injected into a casting mold using a pressurized injection method. Subsequently, air bubbles inside the silicone mixture are eliminated again using vacuuming or vibration. Finally, the silicone mixture is cured in an oven using a stepped heating method. This heating method effectively avoids localized overheating and air bubbles caused by heat accumulation during the curing reaction, ensuring that the silicone material has excellent curing and molding performance.

[0084] Furthermore, after the ultrasonic imaging silicone material is cured and formed in the injection mold, the injection mold can be selectively removed by physical or chemical means. Subsequently, the ultrasonic imaging silicone material is subjected to post-processing steps such as cleaning, drying and surface modification to finally obtain a stable ultrasonic imaging silicone material.

[0085] For example, the injection mold can be physically removed or soaked in high-concentration ethanol for a long time until it softens or becomes brittle. Then, excess ultrasonically recognizable silicone material is trimmed, rinsed with alcohol, and dried in an oven to obtain ultrasonically recognizable silicone material with better ultrasonic imaging performance.

[0086] Figure 2 The images show the ultrasonic imaging effects of two different ultrasonically modifiable silicone materials. Image a represents the ultrasonically modifiable silicone material without white mineral oil modification, and image b represents the ultrasonically modifiable silicone material with white mineral oil modification.

[0087] Reference Figure 1 As shown in a, the penetration depth of unmodified silicone material under ultrasonic imaging equipment is 1-2 cm. (Refer to...) Figure 1 As shown in b, the silicone material modified with white mineral oil completely penetrates the entire ultrasonic field of view during scanning with an ultrasonic imaging device. This demonstrates that adding white mineral oil to silicone materials can significantly improve the penetration depth of the material under ultrasonic imaging.

[0088] Figure 3 This is a flowchart of a method for preparing an ultrasonically developable silicone material according to another embodiment of this application.

[0089] Reference Figure 3 As shown, in a non-limiting embodiment, the preparation process of the silicone material includes the following steps:

[0090] 1) Preparation of functional particles (ultrafine talc)

[0091] Natural talc raw materials are placed in a crushing device for coarse crushing pretreatment, and then transferred to a ball mill jar for fine grinding. The ball mill process parameters are set as follows: the mass ratio of material to grinding media is controlled between 1:1 and 1:10 (for example, it can be controlled at 1:6), the jar rotation speed is set to 200~300 r / min, and the grinding duration can be set to 48h.

[0092] 2) Screening of functional particles

[0093] After ball milling, a single-cell flotation device is used to separate and purify the talc particles. Deionized water is used as the dispersion medium in the flotation process, and the medium volume can be set according to the total amount of talc powder (e.g., 1L). A turbine-type impeller is used to stir the deionized water containing talc powder at a speed of 2000-3000 r / min for a predetermined time to ensure thorough dispersion. Afterward, the mixture is allowed to settle, allowing the talc particles to separate and settle according to their particle size differences in the deionized water. Once the system stabilizes, the suspension is precisely removed from the upper layer of the deionized water and transferred to a drying device for constant temperature drying at 80-100℃ for 48 hours. The dried product is repeatedly ground, dispersed, and screened for extraction to finally obtain functional talc mineral powder with ultrafine particle size.

[0094] 3) Preparation of ultrasonic silica gel mixture

[0095] White mineral oil and liquid silica gel were mixed at a mass ratio of 2:1 and stirred until homogeneous. Several control groups were also set up, in which ultrafine talc powder was added to the mixture of white mineral oil and liquid silica gel at addition ratios of 0.2%, 0.4%, 0.6%, 0.8%, 1.0%, 2.0%, 3.0%, 4.0%, and 5.0%, respectively, and stirred until homogeneous.

[0096] The mixed ultrasonic silica gel solution undergoes a dual process of vacuum defoaming and ultrasonic defoaming. Specifically, negative pressure is first applied in a vacuum dryer, utilizing the decompression expansion mechanism to increase the volume of air bubbles in the solution until they float and escape. The ultrasonic silica gel solution is then transferred to an ultrasonic cleaner for secondary defoaming via ultrasound to ensure the homogeneity of the mixture.

[0097] Then, the ultrasonic silicone mixture is sealed and placed in a -1 to -10°C environment for refrigeration and static storage. By reducing the molecular thermal motion rate and the activation energy of the cross-linking reaction, the pre-curing process of the mixture is effectively inhibited, the viscosity and thixotropic properties are stabilized, thereby extending the operating window period and ensuring the rheological controllability and structural integrity of the subsequent injection molding process.

[0098] 4) Injection curing process

[0099] According to requirements, a photopolymer material is used to print a casting mold using 3D printing technology. After the casting mold is formed, it is immersed in an ethanol solution and left to stand to dissolve and remove unpolymerized liquid resin from the surface of the casting mold. Then, residual impurities on the surface of the casting mold are removed, and then the casting mold is placed in an ultrasonic cleaning device for ultrasonic cleaning to ensure that there are no residual impurities on the surface of the casting mold.

[0100] The casting mold is then placed in an electric heating drying oven and continuously heated to achieve secondary heating and curing of the casting mold. This drives the residual active monomers to complete deep cross-linking, completely consuming the unreacted components in the casting mold and avoiding the poisoning effect on the platinum-based catalytic system on the surface of the casting mold during the subsequent silicone mixture casting stage, thus ensuring that the curing process of the silicone mixture is not disturbed.

[0101] After the casting mold undergoes secondary curing, the supporting structure of the casting mold is removed, and then it is rinsed with deionized water and placed in a ventilated place to dry. To enhance the density of the casting mold surface and improve its release properties, a protective varnish is uniformly coated on the outer surface of the casting mold. After standing treatment until the varnish film is fully cross-linked and cured, it is sealed in a container for later use.

[0102] The prepared ultrasonic silicone mixture was injected into a pre-prepared casting mold using a pressurized injection method. The casting mold was then placed in an ultrasonic device for ultrasonic vibration to degas the mixture and remove any residual air bubbles. The casting mold was then transferred to an oven and subjected to low-temperature thermosetting of the silicone mixture at 30-45°C using a stepped heating method with a temperature increase of 5°C every hour.

[0103] 5) Removal and post-processing of the injection mold

[0104] Remove the external injection mold from the cured ultrasonic imaging silicone material, trim the ultrasonic imaging silicone material, and then clean it with alcohol to obtain the finished product.

[0105] Figure 4 Ultrasonic imaging results of nine groups of ultrasonically developable silicone materials with different proportions of talc added. Figure 4 The number 1 in the image represents the ultrasonic imaging results of silicone material without added talc (left) and modified silicone with added 0.2% by mass of talc. Figure 4The number 2 in the image represents the ultrasonic imaging results of silicone material without talc (left) and modified silicone with 0.4% talc by mass. Figure 4 The number 3 in the image represents the ultrasonic imaging results of silicone material without talc (left) and modified silicone with 0.6% talc by mass. Figure 4 The number 4 in the image represents the ultrasonic imaging results of silicone material without talc (left) and modified silicone with 0.8% talc by mass. Figure 4 The number 5 in the image represents the ultrasonic imaging results of silicone material without talc (left) and modified silicone with 1% talc by mass. Figure 4 The number 6 in the image represents the ultrasonic imaging results of silicone material without talc (left) and modified silicone with 2% talc by mass. Figure 4 The number 7 in the image represents the ultrasonic imaging results of silicone material without talc (left) and modified silicone with 3% talc by mass. Figure 4 The number 8 in the image represents the ultrasonic imaging results of silicone material without talc (left) and modified silicone with 4% talc by mass. Figure 4 The number 9 in the image represents the ultrasonic imaging results of silicone material without talc (left) and modified silicone with 5% talc by mass.

[0106] Reference Figure 4 As shown, within the range of low talc addition (e.g., 0.2%~2%), the grayscale value of modified silicone under ultrasonic imaging increases with the increase of talc mass fraction in the silicone material. The introduction of the acoustic impedance mismatch interface of the silicone material has the most significant effect on the backscatter signal, resulting in the largest increase in the brightness of the ultrasonic image after the addition of talc. This indicates that the higher the talc mass fraction, the stronger the backscatter signal of the silicone material.

[0107] When the amount of talc added is further increased (e.g., 2%~5%), the increase in brightness of the silica gel material shows a significant marginal decrease with the increase in the mass fraction of talc. This is because as the mass fraction of talc in the silica gel material increases, the spacing between solid particles within the silica gel material gradually decreases, which enhances the acoustic interference effect between adjacent scatterers, leading to a decrease in the coherent superposition effect of the scattered signals. At the same time, the tendency of particle aggregation at high concentrations also weakens the effective scattering area of ​​the newly added interfaces. Therefore, the increase in brightness of the silica gel material gradually tends to level off and eventually tends to saturate.

[0108] In summary, this application provides an ultrasound-detectable silicone material suitable for simulating organs and its preparation method. This ultrasound-detectable silicone material uses liquid silicone as the raw material and adds oil-based liquids to the liquid silicone to modify it, thus solving the problem of low penetration depth of silicone under ultrasound imaging. Simultaneously, this application also adds solid powder to the liquid silicone, which can improve the brightness of the liquid silicone under ultrasound imaging, achieving comprehensive optimization of the ultrasound imaging characteristics of the silicone material.

[0109] This silicone material is simple to process, has good dimensional stability, is easy to store, has excellent mechanical properties, stable chemical properties, can withstand high temperatures and is not easily corroded, can maintain long-term stability, has high biosafety and is environmentally friendly, and can significantly extend the service life of ultrasound imaging materials. It is of great significance for promoting the standardization of ultrasound medical training and equipment quality control.

[0110] The above description is only a description of the preferred embodiments of this application and is not intended to limit the scope of this application in any way. Any changes or modifications made by those skilled in the art based on the above disclosure shall fall within the protection scope of this application.

Claims

1. A silicone material suitable for ultrasound imaging of simulated organs, characterized in that, The raw materials for preparing the ultrasonic imaging silicone material include: liquid silicone, oil-based liquids, and solid powders.

2. The ultrasound-enhanced silicone material suitable for simulating organs as described in claim 1, characterized in that, The oily liquid includes at least one of white mineral oil and dimethyl silicone oil; The solid powder includes at least one of cellulose powder, calcium carbonate powder, calcium oxalate powder, talc powder, or gypsum powder.

3. The ultrasound-enhanced silicone material suitable for simulating organs as described in claim 1, characterized in that, The mass ratio of the oil liquid to the liquid silica gel is 0.5:1 to 3:1 by weight.

4. The ultrasound-enhanced silicone material suitable for simulating organs as described in claim 3, characterized in that, Based on the total mass of the oil and the liquid silica gel, the amount of solid powder added is 0.2% to 2%.

5. The ultrasound-enhanced silicone material suitable for simulating organs as described in claim 1, characterized in that, The kinematic viscosity of the oil-based liquid is 5~100 mm. 2 / s.

6. A method for preparing an ultrasound-enhanced silicone material suitable for simulating organs, characterized in that, The method for preparing a silicone material suitable for ultrasound imaging of simulated organs as described in any one of claims 1 to 5 includes the following steps: S01: Add oil-based liquids and solid powders to liquid silica gel, mix them evenly, and then degas to obtain a silica gel mixture; S02: Prepare a casting mold and inject the silicone mixture into the casting mold; S03: The silicone mixture is cured and molded in the injection mold to obtain an ultrasonic imaging silicone material; S04: Remove the injection mold, clean and surface-treat the ultrasonic imaging silicone material to complete the preparation of the ultrasonic imaging silicone material.

7. The method for preparing ultrasound-enhanced silicone material suitable for simulating organs as described in claim 6, characterized in that, In S01, the step of adding the solid powder to the liquid silica gel includes: pulverizing the solid material, then finely grinding the solid material, and obtaining the solid powder through a flotation process.

8. The method for preparing ultrasound-enhanced silicone material suitable for simulating organs as described in claim 6, characterized in that, In step S01, the step of adding the oil liquid and the solid powder to the liquid silica gel respectively includes: First, the solid powder is added to the oil-based liquid and stirred until homogeneous. Then, the oil-based liquid containing the solid powder is added to the liquid silica gel. Alternatively, the oil-based liquid can be added to the liquid silica gel and stirred until homogeneous, and then the solid powder can be added to the mixture of the oil-based liquid and the liquid silica gel.

9. The method for preparing ultrasound-enhanced silicone material suitable for simulating organs as described in claim 6, characterized in that, In S02, the steps for preparing the injection mold include: The casting mold is prepared using a photocurable material and 3D printing technology. The casting mold is then cleaned and cured by secondary heating. A protective layer is then coated on the surface of the casting mold.

10. The method for preparing ultrasound-enhanced silicone material suitable for simulating organs as described in claim 6, characterized in that, In step S02, the step of injecting the silicone mixture into the injection mold includes: The silica gel mixture is injected into the injection mold under pressure, and then degassing is performed under vacuum.

11. The method for preparing ultrasound-enhanced silicone material suitable for simulating organs as described in claim 6, characterized in that, In step S03, the step of curing the silicone mixture in the injection mold to obtain the ultrasonic imaging silicone material includes: The silicone mixture is cured and shaped at low temperature using a stepped heating method to obtain the ultrasonic imaging silicone material.

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