Facial model and product thereof

Abstract

The present application provides a face model and a product thereof. The face model comprises a skin-imitating layer, an intermediate layer and a fascia-imitating layer, and the intermediate layer is arranged between the skin-imitating layer and the fascia-imitating layer; wherein the skin-imitating layer has a Shore hardness greater than 0 HA and less than or equal to 50 HA, the intermediate layer has a penetration greater than 100, and the fascia-imitating layer has a Shore hardness greater than 0 HA and less than or equal to 50 HA. The face model of the present application has similar characteristics to a real face, so that a similar feeling to injecting a real face can be obtained during the process of providing the face model to an operator for injection training, thereby improving the training effect.

Description

Technical Field

[0001] This invention relates to a model and its products, particularly a face model and its products, which can be used for training face injection. Background Technology

[0002] With social development and technological progress, the public's demand for medical care is no longer limited to disease treatment or disability care that may harm physical health, but also includes adjusting and improving appearance and physique to meet personal preferences or public aesthetic standards, thus promoting the booming development of the medical aesthetics (or medical beauty) industry.

[0003] Cosmetic procedures generally include phototherapy (such as laser, ultrasound, or radiofrequency), injectable treatments (such as Botox injections or fillers like hyaluronic acid and collagen), and plastic surgery (such as breast augmentation or liposuction). Phototherapy and injectable treatments, because they do not involve traditional surgery, are collectively referred to as "minimally invasive procedures," and due to their advantages such as small incisions, short treatment and recovery times, and low cost, they have gradually become the main cosmetic procedures. Specifically, phototherapy mainly uses different energy sources (such as lasers, pulsed light, or ultrasound) to act on facial tissues, cells, or proteins through light, heat, or waves with specific frequencies to achieve different cosmetic effects (such as skin tightening, wrinkle reduction, or fading of blemishes). Injectable treatments, on the other hand, involve piercing the facial epidermis with a needle (including sharp and blunt needles) and injecting the substance into the lost tissue to fill, lift, and support the tissue, thereby adjusting facial lines and contours.

[0004] Compared to the more expensive phototherapy, injectable treatments remain the primary consideration for consumers with cosmetic needs. Generally, during injectable treatments, depending on the specific needs and desired effects, the needle needs to pierce the facial epidermis and release the injected material at different depths. However, since facial skin is composed of various parts such as blood vessels, nerves, and connective tissue, and the tissue distribution varies in different areas (such as the outer corner of the eye, cheek, or forehead), minimizing damage to blood vessels and nerve tissue or accidentally injecting the material into blood vessels during needle insertion requires not only a detailed understanding of facial structure and tissue distribution by the operator, but also sufficient proficiency and mastery of injection techniques (such as the needle insertion location, angle, and depth).

[0005] For training in facial injection techniques, facial models simulating human facial structure and contours have been developed to provide operators with opportunities to practice and familiarize themselves with injection techniques. However, current facial models use a single-layer structure to mimic the human face, which is significantly different from the multi-layered structure of a real human face (comprising the epidermis, subcutaneous fat (tissue) layer, and fascia layer, etc.). Therefore, the training effectiveness using existing facial models is still somewhat insufficient.

[0006] Therefore, new facial models that more closely resemble real human faces are still needed to help operators get a feel for actual injections during injection training, thereby contributing to safer injection treatments in clinical practice. Summary of the Invention

[0007] In view of the problems existing in the prior art, the purpose of this invention is to provide a face model that has characteristics similar to a real human face, thereby enabling operators to obtain a similar feel to injecting a real face during injection training, thereby improving the training effect. Furthermore, the distribution of the injected material after injection also affects the treatment effect. The face model of this invention allows operators to instantly confirm the distribution shape of the injected material after injection (e.g., spherical, linear, fan-shaped, or teardrop-shaped) during injection training, thereby effectively training operators' hand gestures and injection techniques when using needles.

[0008] To achieve the aforementioned objectives, the present invention provides a human face model comprising a simulated skin layer, an intermediate layer, and a simulated fascia layer, wherein the intermediate layer is disposed between the simulated skin layer and the simulated fascia layer; wherein the simulated skin layer has a Shore hardness greater than 0 HA and less than or equal to 50 HA, the intermediate layer has a penetration value greater than 100, and the simulated fascia layer has a Shore hardness greater than 0 HA and less than or equal to 50 HA.

[0009] By sequentially arranging the simulated skin layer, the intermediate layer, and the simulated fascia layer, and simultaneously controlling the hardness or needle penetration of each layer within a specific range, the facial model of the present invention can possess characteristics similar to a real human face. For example, the simulated skin layer, the intermediate layer, and the simulated fascia layer can respectively correspond to and simulate the epidermis, subcutaneous fat (tissue) layer, and fascia layer of a real human face. Simultaneously, by controlling the hardness and needle penetration of each layer within a specific range, a blunt needle can be difficult to pierce the simulated skin layer and the simulated fascia layer, but can easily pierce the intermediate layer and release the injected material into it. This simulates the situation where, when injecting into a real human face, the needle is typically inserted into the intermediate subcutaneous fat (tissue) layer to release the injected material. It should be understood that because a blunt needle is difficult to pierce the simulated skin layer, when using the facial model of the present invention for injection training, a sharp needle is usually used first to pierce the simulated skin layer at the desired injection site, and then a blunt needle is used for injection training.

[0010] According to this invention, both the "sharp needle" and the "blunt needle" are needles commonly used in clinical injections in medical or aesthetic settings. A "sharp needle" refers to a needle with a sharp tip, while a "blunt needle" refers to a needle with a rounded tip. Specifically, the commonly used sizes for the sharp needles are 27G (gauge), 0.5 inches (approximately 1.2 cm) or 30G, 0.5 inches, but are not limited to these. The commonly used sizes for the blunt needles are 21G, 22G, 23G, 25G, or 27G, but are not limited to these.

[0011] According to the present invention, the "Shore hardness" is determined by using a type A hardness tester (or Shore A hardness tester) in accordance with the standardized test procedures in ISO 48-4 or ASTM D2240.

[0012] According to this invention, the "penetration" is determined using the standardized test procedure in CNS 10090 K6755. A standard cone is dropped freely into the sample plane at 25°C for 5 seconds, and the depth of insertion is then measured. This depth is the penetration of the sample, expressed in units of 0.1 mm. For example, a penetration of 100 indicates that the standard cone has penetrated the sample to a depth of 10 mm. A higher penetration value indicates a softer sample, i.e., lower viscosity; conversely, a lower penetration value indicates a harder sample, i.e., higher viscosity.

[0013] In some embodiments of the present invention, the penetration of the intermediate layer is greater than 100 and less than or equal to 300. In other embodiments of the present invention, the penetration of the intermediate layer is greater than or equal to 200 and less than or equal to 300.

[0014] In some embodiments of the present invention, the Shore hardness of the skin-like layer is greater than 0 HA and less than or equal to 30 HA. In other embodiments of the present invention, the Shore hardness of the skin-like layer is greater than or equal to 10 HA and less than or equal to 25 HA.

[0015] In some embodiments of the present invention, the Shore hardness of the fascia-like layer is greater than 0 HA and less than or equal to 30 HA. In other embodiments of the present invention, the Shore hardness of the fascia-like layer is greater than or equal to 10 HA and less than or equal to 25 HA.

[0016] In some embodiments of the present invention, the light transmittance of the skin-like layer is greater than 90%. By further increasing the light transmittance of the skin-like layer to greater than 90%, it is possible for operators undergoing injection training to more easily observe and understand the distribution of the injected material after it is released within the intermediate layer.

[0017] In some embodiments of the present invention, the light transmittance of the fascia-like layer is greater than 90%.

[0018] According to the present invention, the method for measuring the "transmittance" is as follows: using a light transmission measuring instrument, after irradiating the sample with a visible light source, the sensor measures the incident light intensity and the light intensity after passing through the sample, respectively. The transmittance is represented by the ratio of the light intensities, which is expressed as a percentage (%).

[0019] In some embodiments of the present invention, the maximum thickness of the simulated skin layer is greater than or equal to 0.1 cm and less than or equal to 0.2 cm. In other embodiments of the present invention, the maximum thickness of the simulated skin layer is greater than or equal to 0.1 cm and less than or equal to 0.15 cm.

[0020] In some embodiments of the present invention, the maximum thickness of the intermediate layer is greater than or equal to 0.3 cm and less than or equal to 1.5 cm. In other embodiments of the present invention, the maximum thickness of the intermediate layer is greater than or equal to 0.3 cm and less than or equal to 1 cm. In still other embodiments of the present invention, the maximum thickness of the intermediate layer is greater than or equal to 0.3 cm and less than or equal to 0.8 cm.

[0021] In some embodiments of the present invention, the maximum thickness of the pseudofascia layer is greater than or equal to 0.3 cm and less than or equal to 1.5 cm. In other embodiments of the present invention, the maximum thickness of the pseudofascia layer is greater than or equal to 0.3 cm and less than or equal to 1 cm.

[0022] In some embodiments of the present invention, the thickness of the area marked on the face model according to the MD Codes system is less than 1.2 cm. The "MD Codes system" refers to a set of multiple specific areas that can be marked on the face during cosmetic injection treatment, where each marked area provides information for improving facial features in that area (e.g., injection depth, injection method, or injection dosage), thereby achieving better overall facial improvement. Specific implementations of the MD Codes system are described in: MD Codes™: A Methodological Approach to Facial Aesthetic Treatment with Injectable Hyaluronic Acid Fillers, de Maio M., Aesth Plast Surg 45, 690-709, 2021.

[0023] According to the present invention, the composition of the simulated skin layer, the intermediate layer, and the simulated fascia layer is not particularly limited. That is, as long as the Shore hardness of the simulated skin layer, the needle penetration of the intermediate layer, and the Shore hardness of the simulated fascia layer are controlled within the aforementioned ranges, the effects of the present invention can be obtained. For example, the components of the simulated skin layer, the intermediate layer, and the simulated fascia layer may each independently include a silicone, a plastic, a rubber, or a combination thereof, but are not limited thereto.

[0024] In some embodiments of the present invention, the silicone may comprise a first siloxane and a second siloxane, wherein the first siloxane is a chain siloxane containing an alkenyl substituent in its chemical structure, and the second siloxane is a chain siloxane containing an alkyl substituent in its chemical structure. Specifically, the alkenyl substituent may be an alkenyl group having 2 to 6 carbon atoms; and the alkyl substituent may be an alkyl group having 1 to 6 carbon atoms.

[0025] In some embodiments of the present invention, the skin-like layer comprises the first siloxane and the second siloxane, and based on the total weight of the skin-like layer, the content of the first siloxane is greater than or equal to 50 weight percent (wt%) and less than 80 wt%, and the content of the second siloxane is greater than 20 wt% and less than or equal to 50 wt%.

[0026] In some embodiments of the present invention, the intermediate layer comprises the first siloxane and the second siloxane, and based on the total weight of the intermediate layer, the content of the first siloxane is greater than 90 wt% and less than or equal to 99 wt%, and the content of the second siloxane is greater than or equal to 1 wt% and less than 10 wt%.

[0027] In some embodiments of the present invention, the composition of the pseudo-fascia layer includes the first siloxane and the second siloxane, and based on the total weight of the pseudo-fascia layer, the content of the first siloxane is greater than or equal to 50 wt% and less than 80 wt%, and the content of the second siloxane is greater than 20 wt% and less than or equal to 50 wt%.

[0028] In some embodiments of the present invention, the silicone also contains a third siloxane, which is a cyclosiloxane.

[0029] In some embodiments of the present invention, the skin-like layer comprises the first siloxane, the second siloxane, and the third siloxane, and based on the total weight of the skin-like layer, the content of the first siloxane is greater than or equal to 50 and less than 80 wt%, the content of the second siloxane is greater than 20 wt% and less than or equal to 50 wt%, and the content of the third siloxane is greater than 0 wt% and less than or equal to 1 wt%.

[0030] In some embodiments of the present invention, the components of the skin-like layer, the intermediate layer, and the fascia-like layer may each independently contain a catalyst for promoting the curing and forming of each layer. Specifically, the catalyst may be a platinum catalyst, but is not limited thereto.

[0031] In some embodiments of the present invention, when the components of the simulated skin layer, the intermediate layer or the simulated fascia layer contain the catalyst, the content of the catalyst is greater than 0.05 wt% and less than 0.1 wt%, based on the total weight of the simulated skin layer, the intermediate layer or the simulated fascia layer.

[0032] In some embodiments of the present invention, the composition of the simulated skin layer may be the same as or different from the composition of the simulated fascia layer; the composition of the intermediate layer may be the same as or different from the composition of the simulated skin layer or the simulated fascia layer.

[0033] In addition, the present invention provides a face model product, which includes a base and a face model as described above, wherein the face model is fitted onto the base. When actually using the face model product, injection training can be performed on the face model fitted onto the base; furthermore, after a single injection training session, the used face model can be removed from the base, and an unused face model can be fitted onto the base to facilitate the next injection training session.

[0034] In this specification, the range represented by "smallest value to largest value" means, unless otherwise specified, that the range is greater than or equal to the smallest value and less than or equal to the largest value. For example, a carbon number of 2 to 6 means that the range of carbon numbers can be "greater than or equal to 2 and less than or equal to 6". Attached Figure Description

[0035] Figure 1 This is a schematic diagram of the appearance of the human face model of the present invention.

[0036] Figure 2 This is a cross-sectional side view of the human face model of the present invention. Detailed Implementation

[0037] The following examples illustrate the implementation of the present invention. Those skilled in the art can easily understand the advantages and effects of the present invention through the following examples. It should be understood that the examples listed in this specification are only for illustrative purposes and are not intended to limit the scope of the present invention. Those skilled in the art can make various modifications and alterations based on their general knowledge without departing from the spirit of the present invention to implement or apply the content of the present invention.

[0038] Example 1: Face Model

[0039] like Figure 1 and Figure 2 As shown, the face model 1 of Embodiment 1 has a three-layer structure, which are respectively a simulated skin layer 11, an intermediate layer 12, and a simulated fascia layer 13, and the intermediate layer 12 is disposed between the simulated skin layer 11 and the simulated fascia layer 13. The preparation process of the face model of Embodiment 1 is as follows.

[0040] First, a male mold and a female mold with a human face shape and contour are provided, and the shapes of the male mold and the female mold correspond to each other and can be pressed together.

[0041] Next, dimethylvinyl and trimethylsiloxane (CAS No.: 68988-89-6), polydimethylsiloxane (CAS No.: 63148-62-9), and platinum catalyst are uniformly mixed to obtain a first mixture. Subsequently, the first mixture is injected into the simulated skin layer master mold, and the simulated skin layer male mold is pressed against the simulated skin layer master mold containing the first mixture. The mixture is then left to stand for approximately 6 hours to allow the first mixture to solidify and form the simulated skin layer 11. Afterward, the simulated skin layer male mold is removed. Based on the total weight of the simulated skin layer 11, the content of dimethylvinyl and trimethylsiloxane is greater than or equal to 50 wt% and less than 80 wt%, the content of polydimethylsiloxane is greater than 20 wt% and less than or equal to 50 wt%, and the content of platinum catalyst is greater than 0.05 wt% and less than 0.1 wt%. The skin-like layer 11 has a Shore hardness of approximately 18 HA and a light transmittance of approximately 94%.

[0042] Next, ethylene polydimethylsiloxane (CAS No.: 68083-19-2), hydrogen-containing polydimethylsiloxane (CAS No.: 68037-59-2), and polydimethylsiloxane (CAS No.: 63148-62-9) are uniformly mixed to obtain a second mixture. Subsequently, the second mixture is injected onto the simulated skin layer 11, and an intermediate layer mold is used to press the injected simulated skin layer 11 against it. The mixture is then left to stand for approximately 12 hours to allow the second mixture to solidify and form the intermediate layer 12. The intermediate layer mold is then removed. Based on the total weight of the intermediate layer 12, the content of ethylene polydimethylsiloxane is greater than 90 wt% and less than or equal to 99 wt%, and the total content of hydrogen-containing polydimethylsiloxane and polydimethylsiloxane is greater than or equal to 1 wt% and less than 10 wt%. The penetration of the intermediate layer 12 is approximately 240°.

[0043] Next, dimethylvinyl and trimethylsiloxane (CAS No.: 68988-89-6), polydimethylsiloxane (CAS No.: 63148-62-9), and platinum catalyst are uniformly mixed to obtain a third mixture. Subsequently, the third mixture is injected onto the intermediate layer 12, and a fascia-like layer mold is pressed onto the intermediate layer 12 containing the third mixture. The mixture is then left to stand for approximately 6 hours to allow the third mixture to solidify and form the fascia-like layer 13. The fascia-like layer mold is then removed. Based on the total weight of the fascia-like layer 13, the content of dimethylvinyl and trimethylsiloxane is greater than or equal to 50 wt% and less than 80 wt%, the content of polydimethylsiloxane is greater than 20 wt% and less than or equal to 50 wt%, and the content of platinum catalyst is greater than 0.05 wt% and less than 0.1 wt%. The simulated fascia layer 13 has a Shore hardness of approximately 18 HA and a light transmittance of approximately 94%.

[0044] Finally, the finished product formed by sequentially stacking the imitation skin layer 11, the intermediate layer 12, and the imitation fascia layer 13 is demolded from the imitation skin layer master mold to obtain the human face model 1 of Example 1.

[0045] Experimental example: Blunt needle puncture test

[0046] This experimental example uses the face model from Example 1 for testing. Specifically, following the standard clinical procedure and techniques for injectable treatment, a 23G blunt needle was used to attempt puncture the simulated skin layer of the face model from Example 1. The test results showed that it was difficult to puncture the simulated skin layer of the face model from Example 1 using a 23G blunt needle, a result similar to that of an actual face. Furthermore, during injection training, a sharp needle (e.g., a 23G or 27G sharp needle) was used to first puncture the simulated skin layer of the face model from Example 1 at the insertion point, and then replaced with a 23G blunt needle to pass through the simulated skin layer. When the 23G blunt needle contacted the middle layer of the face model from Example 1, it could easily puncture the middle layer and allow the needle to enter, subsequently releasing the injected material into the middle layer, similar to the situation of actual face injection. Therefore, it can be concluded that the face model of the present invention can indeed improve the effectiveness of injection training.

[0047] In summary, the facial model provided by this invention, by setting a three-layer structure of a simulated skin layer, an intermediate layer, and a simulated fascia layer, and simultaneously controlling the hardness or needle penetration of each layer, allows the facial model of this invention to have characteristics similar to a real human face. This provides operators with a similar feel to injecting a real face during injection training, thereby helping to make injectable treatments safer in clinical practice.

[0048] The above description is merely a preferred embodiment of the present invention and is not intended to limit the present invention in any way. Although the present invention has been disclosed above with reference to preferred embodiments, it is not intended to limit the present invention. Any person skilled in the art can make some modifications or alterations to the above-disclosed technical content to create equivalent embodiments without departing from the scope of the technical solution of the present invention. Any simple modifications, equivalent changes and alterations made to the above embodiments based on the technical essence of the present invention without departing from the content of the technical solution of the present invention shall still fall within the scope of the technical solution of the present invention.

Claims

1. A human face model comprising a simulated skin layer, an intermediate layer, and a simulated fascia layer, wherein the intermediate layer is disposed between the simulated skin layer and the simulated fascia layer; wherein, The Shore hardness of the skin-like layer is greater than 0 HA and less than or equal to 50 HA, the penetration of the intermediate layer is greater than 100, and the Shore hardness of the fascia-like layer is greater than 0 HA and less than or equal to 50 HA.

2. The face model as described in claim 1, characterized in that, The penetration of the intermediate layer is greater than 100 and less than or equal to 300.

3. The face model as described in claim 2, characterized in that, The penetration of the intermediate layer is greater than 200 and less than or equal to 300.

4. The face model as described in claim 1, characterized in that, The Shore hardness of the skin-like layer is greater than 0 HA and less than or equal to 30 HA.

5. The face model as described in claim 1, characterized in that, The Shore hardness of the fascia-like layer is greater than 0 HA and less than or equal to 30 HA.

6. The face model as described in claim 1, characterized in that, The light transmittance of this skin-like layer is greater than 90%.

7. The face model as described in claim 1, characterized in that, The maximum thickness of the intermediate layer is greater than or equal to 0.3 cm and less than or equal to 1.5 cm.

8. The face model as described in claim 1, characterized in that, The components of the skin-like layer, the intermediate layer, and the fascia-like layer each independently comprise a silicone, a plastic, a rubber, or a combination thereof.

9. A face model product, characterized in that, It includes a base and a face model as described in any one of claims 1 to 8, wherein the face model is fitted onto the base.

Images