Hifu phantom gel material and preparation method and application thereof

Abstract

The application provides a HIFU phantom gel material and a preparation method and application thereof, relates to the technical field of medical functional materials, and the raw material of the HIFU phantom gel material comprises butadiene rubber and dicumyl peroxide (DCP); the amount of dicumyl peroxide is 1%-3% of the mass of butadiene rubber. The HIFU phantom gel material is prepared by using butadiene rubber and a specific amount of dicumyl peroxide crosslinking agent, does not need additional additives, is non-toxic and harmless, has good biocompatibility, and is precisely matched with human soft tissue in mechanical properties and ultrasonic characteristics (sound velocity, acoustic impedance and ultrasonic absorption coefficient), so that the HIFU ablation process and effect can be precisely simulated, and there is no dehydration, shrinkage or mildew phenomenon in long-term use, and the technical problems of the existing HIFU phantom gel material, such as complex components, many additives, complicated process, mismatched ultrasonic characteristics and mechanical properties and poor ablation simulation effect, are solved.

Description

Technical Field

[0001] This invention relates to the technical field of medical functional materials, and in particular to a HIFU phantom gel material, its preparation method, and its application. Background Technology

[0002] High-intensity focused ultrasound (HIFU) technology, as a non-invasive treatment method, is widely used in the treatment of diseases such as tumors. The precision of its treatment effect and the quality control of the equipment both depend on high-performance HIFU phantoms. HIFU phantoms must meet the following core requirements: mechanical properties matching human soft tissue, ultrasound velocity and acoustic impedance adapted to HIFU focusing characteristics, ability to simulate morphological changes after ultrasound ablation, long-term stability, safety, non-toxicity, and the ability to be mass-produced to provide a reliable carrier for HIFU equipment calibration, treatment parameter optimization, and clinical operation training.

[0003] Most existing HIFU phantom gel materials employ multi-component compound systems, which generally suffer from the following technical drawbacks: First, the composition is complex, requiring the addition of various additives such as silicone oil, reinforcing agents, ultrasound modifiers, and antibacterial agents. This not only increases preparation costs but also easily leads to uneven component dispersion, affecting ultrasound transmission characteristics and ablation simulation effects, while also being prone to delamination and cracking. Second, some additives pose potential toxicity risks, failing to meet medical-grade requirements and thus unable to meet the stringent demands of HIFU clinical training and equipment calibration. Third, the synergistic effect of multiple components is difficult to control, resulting in significant ultrasound parameter drift and an inability to accurately simulate the absorption and reflection characteristics of HIFU by human soft tissue. Fourth, the preparation process is cumbersome, with difficult multi-component mixing, hindering mass molding production and making it difficult to meet the needs of large-scale HIFU phantom applications. Furthermore, traditional single-rubber HIFU phantom materials either have excessively high hardness and poor mechanical properties that match human soft tissue, or they suffer from insufficient cross-linking and unstable ultrasound characteristics.

[0004] Therefore, developing a HIFU phantom gel with simple components (only two components), no unnecessary additives, mechanical and ultrasonic properties adapted to HIFU, and capable of mass molding is an urgent need in the current HIFU technology field and a key to solving the current technological bottlenecks.

[0005] In view of this, the present invention is hereby proposed. Summary of the Invention

[0006] One of the objectives of this invention is to provide a HIFU phantom gel material that can accurately display the focal position, focal zone shape and size under focused ultrasound energy, thereby changing the reversible nature of its original gel energy form and making it suitable for scenarios such as HIFU equipment calibration and clinical training.

[0007] The second objective of this invention is to provide a method for preparing HIFU phantom gel material that is simple and convenient to operate, highly practical, and conducive to mass production.

[0008] The third objective of this invention is to provide an application of HIFU phantom gel material.

[0009] In order to achieve the above-mentioned objectives of the present invention, the following technical solution is adopted: In a first aspect, a HIFU body mold gel material, wherein the raw materials of the HIFU body mold gel material include butadiene rubber and dicumyl peroxide; The amount of dicumyl peroxide used is 1%-3% of the mass of butadiene rubber.

[0010] Furthermore, the sound velocity of the HIFU phantom gel material is 1520 m / s.

[0011] Furthermore, the light transmittance of the HIFU phantom gel material is ≥80%.

[0012] Furthermore, the surface hardness of the HIFU phantom gel material is Shore A 30-40 degrees.

[0013] Secondly, a method for preparing the HIFU phantom gel material according to any one of the above claims includes the following steps: Dicumyl peroxide was added to butadiene rubber for mixing and molding to obtain the HIFU body mold gel material.

[0014] Furthermore, the compression molding process includes the steps of mold opening and venting, mold filling, and timed vulcanization.

[0015] Furthermore, the molding temperature is 150℃-180℃.

[0016] Furthermore, the compression molding pressure is 10MPa-25MPa.

[0017] Thirdly, the application of any of the above-mentioned HIFU phantom gel materials in simulating the HIFU ablation process and effect.

[0018] Compared with the prior art, the present invention has at least the following beneficial effects: The HIFU phantom gel material provided by this invention is an irreversible phantom that can display focused ultrasound energy. It is made of butadiene rubber with a specific amount of dicumyl peroxide (DCP) crosslinking agent. It not only requires no additional additives, is non-toxic and harmless, and has good biocompatibility, but also precisely matches the mechanical properties and ultrasonic characteristics (sound velocity, acoustic impedance, and ultrasonic absorption coefficient) of human soft tissue. It can accurately simulate the HIFU ablation process and effect. It does not dehydrate, shrink, or mold even after long-term use. It solves the technical problems of existing HIFU phantom gel materials, such as complex composition, many additives, complicated processes, mismatch between ultrasonic characteristics and mechanical properties, and poor ablation simulation effect. The HIFU phantom gel material of this invention can accurately display the focal position, focal zone morphology and size under focused ultrasound energy, changing the reversible characteristic of its original gel energy form, and is suitable for HIFU equipment calibration, clinical training and other scenarios.

[0019] The method for preparing HIFU phantom gel material provided by this invention is simple and convenient to operate, highly practical, and can be mass-produced through compression molding. The resulting material has the original energy conduction characteristics of cis-butadiene rubber and maintains the initial high-permeability morphology of cis-butadiene rubber. Attached Figure Description

[0020] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained from these drawings without creative effort.

[0021] Figure 1 This is a diagram demonstrating the effectiveness of the HIFU phantom gel material of this invention. Figure 2 The image shows a physical model of a transparent hydrogel phantom (PVA) material for comparison. Figure 3 This is a physical image of the material used to simulate the ultrasonic thermal effect of the liver, serving as a comparative example. Detailed Implementation

[0022] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0023] According to a first aspect of the present invention, a HIFU phantom gel material is provided, the raw materials of which include butadiene rubber and dicumyl peroxide; The amount of dicumyl peroxide used is 1%-3% of the mass of butadiene rubber.

[0024] In this invention, the HIFU phantom gel material is made of butadiene rubber with a specific amount of dicumyl peroxide (DCP) crosslinking agent. It not only requires no additional additives, is non-toxic and harmless, and has good biocompatibility, but also has mechanical properties and ultrasonic characteristics (sound velocity, acoustic impedance, and ultrasonic absorption coefficient) that are precisely matched to human soft tissue. It can accurately simulate the HIFU ablation process and effect. Even after long-term use, there is no dehydration, shrinkage, or mold growth. This invention solves the technical problems of existing HIFU phantom gel materials, such as complex composition, many additives, complicated processes, mismatch between ultrasonic characteristics and mechanical properties, and poor ablation simulation effect.

[0025] In a preferred embodiment, the sound velocity of the HIFU phantom gel material can be 1520 m / s, possessing the original energy conduction characteristics of butadiene rubber while maintaining the initial high transparency of cis-butadiene rubber. Under ultrasonic focusing energy, it can accurately display the focal position, focal zone shape, and size.

[0026] In a preferred embodiment, the light transmittance of the HIFU phantom gel material is ≥80%.

[0027] In a preferred embodiment, the surface hardness of the HIFU phantom gel material is Shore A 30-40. Its mechanical properties and ultrasonic characteristics (sound velocity, acoustic impedance, ultrasonic absorption coefficient) are precisely matched to human soft tissue, allowing for accurate simulation of the HIFU ablation process and effects.

[0028] The HIFU phantom gel material of this invention records the shape, size, and location of the ultrasonic focal zone through visual observation or an image acquisition system, see [link / documentation]. Figure 1 The focusing performance and expected therapeutic effect of the ultrasound transducer were verified. It is evident that the HIFU phantom gel material of this invention is well-suited for ultrasound-guided devices, and the HIFU-treated area is clearly visible in the ultrasound images.

[0029] In summary, the HIFU phantom gel material of this invention can accurately simulate the HIFU ablation process and effect, and does not exhibit dehydration, shrinkage, or mold growth even after long-term use, making it suitable for scenarios such as HIFU equipment calibration and clinical training.

[0030] According to a second aspect of the present invention, a method for preparing the HIFU phantom gel material according to any one of the above claims is provided, comprising the following steps: Dicumyl peroxide was added to butadiene rubber for mixing and molding to obtain HIFU body mold gel material.

[0031] The preparation method of this invention is simple and convenient to operate, highly practical, and can be mass-produced through compression molding. The resulting material has the original energy conduction characteristics of cis-butadiene rubber and maintains the initial high transparency of cis-butadiene rubber.

[0032] In a preferred embodiment, compression molding includes, but is not limited to, steps of mold opening and venting, mold filling, and timed vulcanization.

[0033] A typical method for preparing a HIFU phantom gel material includes the following steps: (1) Put the raw butadiene rubber into the open mill, ensure that the roller temperature and the mixing chamber temperature are <45℃, mix and soften it; (2) Add dicumyl peroxide to the material in step (1) and refining until homogeneous; The amount of dicumyl peroxide added is 1%-3% of the mass of butadiene rubber; (3) After the mixing in step (2) is completed, the sheet is cooled to room temperature to obtain the semi-finished material; (4) Install the mold onto the flat vulcanizing machine (providing mold closing pressure, heating, and pressure holding) for preheating; (5) Weigh the semi-finished material from step (3) according to the volume of the mold cavity. The amount of material should be slightly larger than the volume of the mold cavity to ensure filling and avoid insufficient glue. Place the rubber material into the mold cavity, centering it to avoid uneven loading; (6) After the material loading in step (5) is completed, close the mold under low pressure and vent the air (open the mold to release the air instantly) to remove air and volatiles and prevent air bubbles; (7) Increase the pressure to the preset pressure, compact the material, fill the mold, eliminate air bubbles, and improve density; Timed vulcanization; (8) After vulcanization is completed, release the pressure and open the mold, take out the product, trim and deburr it, inspect and put it into storage to obtain the finished HIFU body mold gel material.

[0034] In a preferred embodiment, the molding temperature can be 150℃-180℃, which is more conducive to further improving the molding effect.

[0035] In a preferred embodiment, the compression molding pressure can be 10MPa-25MPa, which is more conducive to further improving the molding effect.

[0036] According to a third aspect of the present invention, an application of the HIFU phantom gel material described in any of the above claims in simulating the HIFU ablation process and effect is provided.

[0037] The present invention will be further illustrated by the following examples. Unless otherwise specified, the materials in the examples are prepared according to existing methods or purchased directly from the market.

[0038] Example 1 A method for preparing a HIFU phantom gel material includes the following steps: (1) Put the raw butadiene rubber (grade BR900) into the open mill, ensure that the roller temperature and the mixing chamber temperature are <45℃, and mix for 1min-3min to soften it; (2) Add dicumyl peroxide to the material in step (1), and refining until uniform, repeating 5-10 times to improve the dispersion uniformity; The amount of dicumyl peroxide added is 2% of the mass of butadiene rubber; (3) After the mixing in step (2) is completed, the sheet is cooled to room temperature to obtain the semi-finished material; (4) Install the mold onto the flat vulcanizing machine (which provides mold closing pressure, heating, and pressure holding) and preheat it to 150℃-180℃, maintaining a constant temperature; (5) Weigh the semi-finished material from step (3) according to the volume of the mold cavity, and the amount of material should be slightly larger than the volume of the mold cavity (greater than 3%-5%) to ensure filling the mold and avoid insufficient glue; Place the rubber material into the mold cavity, centering it to avoid uneven loading; (6) After the material loading in step (5) is completed, close the mold under low pressure and vent the air 2-3 times (open the mold to release air instantly) to remove air and volatiles and prevent air bubbles; (7) Increase the pressure to 18MPa, compact the material, fill the mold, eliminate air bubbles, and improve density; Vulcanization for 8 minutes at set time; (8) After vulcanization is completed, release the pressure and open the mold, take out the product, trim and deburr it, inspect and put it into storage to obtain the finished HIFU body mold gel material.

[0039] Example 2 The only difference between this embodiment and Embodiment 1 is that, in step (2), the amount of dicumyl peroxide added is 1% of the mass of butadiene rubber; The rest were the same as in Example 1, and HIFU phantom gel material was obtained.

[0040] Example 3 The only difference between this embodiment and Example 1 is that, in step (2), the amount of dicumyl peroxide added is 3% of the mass of butadiene rubber; The rest were the same as in Example 1, and HIFU phantom gel material was obtained.

[0041] Example 4 The only difference between this embodiment and embodiment 1 is that, in step (7), the pressure is increased to 10 MPa; The rest were the same as in Example 1, and HIFU phantom gel material was obtained.

[0042] Example 5 The only difference between this embodiment and Embodiment 1 is that, in step (7), the pressure is increased to 25 MPa; The rest were the same as in Example 1, and HIFU phantom gel material was obtained.

[0043] Comparative Example 1 The only difference between this comparative example and Example 1 is that, in step (1), butadiene rubber is replaced with silicone. The rest were the same as in Example 1, and HIFU phantom gel material was obtained.

[0044] Compared with Example 1, the drawback of this comparative example is that it does not have the characteristics of a human model.

[0045] Comparative Example 2 The only difference between this comparative example and Example 1 is that, in step (2), dicumyl peroxide is replaced with platinum catalyst SC-PTC-300; The rest were the same as in Example 1, and HIFU phantom gel material was obtained.

[0046] Compared with Example 1, the drawback of this comparative example is that it lacks light transmittance.

[0047] Comparative Example 3 The only difference between this comparative example and Example 1 is that, in step (2), the amount of dicumyl peroxide added is 0.5% of the mass of butadiene rubber; The rest were the same as in Example 1, and HIFU phantom gel material was obtained.

[0048] Compared with Example 1, the drawback of this comparative example is that the phantom cannot be cross-linked and molded, and a phantom with a normal shape cannot be obtained.

[0049] Comparative Example 4 The only difference between this comparative example and Example 1 is that, in step (2), the amount of dicumyl peroxide added is 3.5% of the mass of butadiene rubber; The rest were the same as in Example 1, and HIFU phantom gel material was obtained.

[0050] Compared with Example 1, the drawback of this comparative example is that the phantom is brittle and cannot be obtained in a normal shape.

[0051] Comparative Example 5 This comparative example provides a transparent hydrogel phantom (PVA) material, see [link / reference]. Figure 2 It possesses a unique thermochromic capability; once the temperature exceeds a set threshold, the material changes from transparent to white. This thermochromic process is completely reversible. When the ultrasonic energy is removed and the phantom temperature gradually drops below the threshold, the discolored area slowly returns to its initial transparent state.

[0052] Compared with the HIFU phantom gel material of Example 1, the transparent hydrogel phantom (PVA) material of this comparative example is not only complicated to prepare and has a long cycle, but also inconvenient to store, easy to dehydrate, and the ultrasonic energy points will fade.

[0053] Comparative Example 6 This comparative example provides a phantom material that mimics the ultrasonic thermal effect of the liver. Figure 3 It mimics the acoustic properties and heat-induced color change of beef liver. When the temperature in the focal area within the phantom reaches approximately 60°C, the material stably turns yellow; when the temperature further rises to approximately 80°C, the area turns white. This color change is irreversible.

[0054] Compared with the HIFU phantom gel material of Example 1, the liver-mimicking ultrasound thermal effect phantom material of this comparative example is not only complicated to prepare and has a long cycle, but also inconvenient to store, easy to dehydrate, and the ultrasound energy points need to be cut open for observation.

[0055] Test case The performance of the HIFU phantom gel materials of the examples and comparative examples was tested, and the results are shown in Table 1.

[0056] Table 1

[0057] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them; although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features; and these modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A HIFU phantom gel material, characterized in that, The raw materials of the HIFU phantom gel material include butadiene rubber and dicumyl peroxide; The amount of dicumyl peroxide used is 1%-3% of the mass of butadiene rubber.

2. The HIFU phantom gel material according to claim 1, characterized in that, The sound velocity of the HIFU phantom gel material is 1520 m / s.

3. The HIFU phantom gel material according to claim 1, characterized in that, The light transmittance of the HIFU phantom gel material is ≥80%.

4. The HIFU phantom gel material according to any one of claims 1-3, characterized in that, The surface hardness of the HIFU phantom gel material is Shore A 30-40.

5. A method for preparing the HIFU phantom gel material according to any one of claims 1-4, characterized in that, Includes the following steps: Dicumyl peroxide was added to butadiene rubber for mixing and molding to obtain the HIFU body mold gel material.

6. The preparation method according to claim 5, characterized in that, The compression molding process includes steps such as mold opening and venting, mold filling, and timed vulcanization.

7. The preparation method according to claim 5, characterized in that, The molding temperature is 150℃-180℃.

8. The preparation method according to claim 7, characterized in that, The compression molding pressure is 10MPa-25MPa.

9. The application of the HIFU phantom gel material according to any one of claims 1-4 in simulating the HIFU ablation process and effect.

Images