Face models and their products

Abstract

This invention provides a face model and its product. The face model comprises a simulated skin layer, an intermediate layer, and a simulated fascia layer, with the intermediate layer disposed between the simulated skin layer and the simulated fascia layer. 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 needle penetration greater than 100, and the simulated fascia layer has a Shore hardness greater than 0 HA and less than or equal to 50 HA. The face model of this invention has characteristics similar to a real human face, thereby providing operators with a similar feel to injecting into a real face during injection training, thus improving training effectiveness.

Description

Technical Field

[0001] The present invention relates to a model and a product thereof, in particular to a human face model and a product thereof, which can be used for training of human face injection. Prior Art

[0002] With the development of society and the advancement of science and technology, the public's demand for medical care is no longer limited to the treatment of diseases or disabilities that may endanger physical health, but also covers the adjustment and improvement of appearance and body shape to meet personal preferences or public aesthetic standards, thus promoting the increasingly vigorous development of the medical cosmetology (or medical beauty for short) industry.

[0003] Medical aesthetic projects generally include phototherapy (such as laser, sound wave or radio wave), injection therapy (such as injection of botulinum toxin or injection of fillers such as hyaluronic acid and collagen) and plastic surgery (such as breast augmentation or liposuction). Among them, phototherapy and injection therapy are collectively referred to as "micro-plastic surgery" because they do not involve traditional surgical operations. They have gradually become the main projects of medical aesthetics due to their advantages such as small wounds, short treatment and recovery time and low cost. Specifically, phototherapy mainly uses different energy sources (such as laser, pulsed light or ultrasound) to act on facial tissues, cells or proteins through light, heat or waves with special frequencies to achieve different cosmetic effects (such as skin tightening, anti-wrinkle or light spot, etc.); while injection therapy mainly uses a needle (including sharp needles and blunt needles) to pierce the epidermis of the face and inject the injection into the lost area to fill, lift and support the tissue, thereby achieving the effect of adjusting the facial lines and contours.

[0004] Compared to the more expensive photoelectric treatment, injection treatment is still the primary consideration for consumers with medical aesthetic needs. Generally speaking, during the injection treatment, according to different needs and effects, the needle needs to pierce the facial epidermis and release the injection at different depths. However, since the facial skin is composed of different parts such as blood vessels, nerves and connective tissues, and the tissue distribution in different parts (such as the tail of the eye, cheeks or forehead, etc.) is also different, how to minimize damage to blood vessels and nerve tissues or mistakenly fill the injection into the blood vessels during needle insertion requires not only the operator's detailed understanding of the facial structure and tissue distribution, but also the operator's sufficient proficiency and mastery of injection techniques (such as the location, angle, depth, etc. of the needle).

[0005] For training of facial injection techniques, face models that simulate the structure and contours of the human face have been developed on the market to provide operators with practice and familiarity with the relevant techniques of needle insertion. However, the current face models all use a single-layer structure to imitate the human face, which is obviously different from the multi-layer structure of the real human face (including the epidermis, subcutaneous fat (tissue) layer and fascia layer, etc.), so the training effect of using the existing face models is still insufficient.

[0006] Based on this, there is still a need to develop new face models that are closer to real human faces, so as to help operators get closer to the actual feel of injection during injection training, thereby helping to perform injection treatment more safely in clinical practice. Summary of the invention

[0007] In view of the problems existing in the above-mentioned prior art, the purpose of the present invention is to provide a human face model, which has characteristics similar to a real human face, so that the operator can obtain a hand feeling similar to that when injecting a real human face during the injection training, thereby improving the training effect. In addition, the distribution of the injection after injection will also affect the treatment effect, and the human face model of the present invention can allow the operator to instantly confirm the distribution shape of the injection after injection (such as spherical, linear, fan-shaped or water drop-shaped, etc.) during the injection training process, thereby effectively training the operator to use the needle body injection gestures and injection skills.

[0008] To achieve the aforementioned object, the present invention provides a human face model, which comprises a simulated skin layer, a middle layer and a simulated fascia layer, and the middle layer is arranged between the simulated skin layer and the simulated fascia layer; wherein the Shore hardness of the simulated skin layer is greater than 0 HA and less than or equal to 50 HA, the penetration value of the middle layer is greater than 100, and the Shore hardness of the simulated fascia layer is greater than 0 HA and less than or equal to 50 HA.

[0009] By sequentially arranging the three-layer structure of the simulated skin layer, the middle layer and the simulated fascia layer, and controlling the hardness or needle penetration of the aforementioned layers within a specific range, the face model of the present invention can have characteristics similar to those of a real face. For example, the simulated skin layer, the middle layer and the simulated fascia layer can correspond to and simulate the epidermis, subcutaneous fat (tissue) layer and fascia layer of a real face respectively; at the same time, by controlling the hardness and needle penetration of the aforementioned layers within a specific range, it is possible to make it difficult for a blunt needle to pierce the simulated skin layer and the simulated fascia layer, but it is possible to easily pierce into the middle layer and release the injection into the layer, thereby simulating the situation in which a real face is injected, and the needle body is usually placed in the middle subcutaneous fat (tissue) layer and the injection is released. It should be understood that since it is difficult for a blunt needle to pierce the simulated skin layer, when using the face model of the present invention for injection training, a sharp needle is usually used to pierce the simulated skin layer at the position where the needle is to be inserted, and then a blunt needle is used for injection training.

[0010] According to the present invention, the "sharp needle" and "blunt needle" are both needles commonly used for injections in medical or aesthetic medicine. The "sharp needle" refers to a needle with a sharp tip, and the "blunt needle" refers to a needle with a blunt tip. Specifically, the commonly used size of the sharp needle can be a 27G (gauge), 0.5 inch (about 1.2 cm) sharp needle or a 30G, 0.5 inch sharp needle, but not limited to this. The commonly used size of the blunt needle can be a 21G, 22G, 23G, 25G or 27G blunt needle, but not limited to this.

[0011] According to the present invention, the "Shore hardness" is measured using a type A durometer (or Shore A durometer) according to the standardized test procedures in ISO 48-4 or ASTM D2240.

[0012] According to the present invention, the "needle penetration" is based on the standardized test procedure in CNS 10090 K6755, where a standard cone is freely dropped into the sample plane for 5 seconds at a temperature of 25°C, and then the depth of its insertion is measured, which is the needle penetration of the sample, and its unit is 0.1 mm; for example, when the needle penetration is 100, it means that the depth of the standard cone inserted into the sample is 10 mm. The larger the value of the needle penetration, the softer the sample, that is, the smaller the consistency; conversely, it means that the sample is harder, that is, the greater the consistency.

[0013] In some embodiments of the present invention, the needle penetration of the intermediate layer is greater than 100 and less than or equal to 300. In other embodiments of the present invention, the needle 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 imitation skin 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 imitation skin 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 simulated fascia 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 simulated fascia 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 simulated skin layer is greater than 90%. By further increasing the light transmittance of the simulated skin layer to greater than 90%, operators conducting injection training can more easily observe and understand the distribution of the injected substance after it is released in the middle layer.

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

[0018] According to the present invention, the method for measuring the "light transmittance" is as follows: use a light transmission measuring instrument, and after irradiating the sample with a visible light source, use a sensor to measure the incident light intensity of the light source and the light intensity after passing through the sample, and the ratio of the light intensities represents the light transmittance, 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 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 simulated fascia 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 simulated fascia 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 collection of multiple specific areas that can be marked on the face during medical aesthetic injection treatment, where each marked area can provide information for improving the facial features of the area (such as injection depth, injection method or injection dose, etc.), thereby achieving a better improvement effect on the overall face. The specific implementation of the MD Codes system is recorded in: MD Codes™: A Methodological Approach to Facial Aesthetic Treatment with Injectable Hyaluronic Acid Fillers, de Maio M., Aesth Plast Surg45, 690-709, 2021.

[0023] According to the present invention, the components of the simulated skin layer, the intermediate layer and the simulated fascia layer are 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 specific ranges, the effect of the present invention can be achieved. For example, the components of the simulated skin layer, the intermediate layer and the simulated fascia layer can 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 include 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 composition of the imitation skin layer includes the first silicone and the second silicone, and based on the total weight of the imitation skin layer, the content of the first silicone is greater than or equal to 50 weight percent (wt%) and less than 80 wt%, and the content of the second silicone is greater than 20 wt% and less than or equal to 50 wt%.

[0026] In some embodiments of the present invention, the composition of the intermediate layer includes 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 imitation fascia layer includes the first silicone and the second silicone, and based on the total weight of the imitation fascia layer, the content of the first silicone is greater than or equal to 50 wt% and less than 80 wt%, and the content of the second silicone is greater than 20 wt% and less than or equal to 50 wt%.

[0028] In some embodiments of the present invention, the silicone further comprises a third siloxane, and the third siloxane is a cyclosiloxane.

[0029] In some embodiments of the present invention, the composition of the imitation skin layer includes the first silicone, the second silicone and the third silicone, and based on the total weight of the imitation skin layer, the content of the first silicone is greater than or equal to 50 wt% and less than 80 wt%, the content of the second silicone is greater than 20 wt% and less than or equal to 50 wt%, and the content of the third silicone 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 simulated skin layer, the middle layer and the simulated fascia layer may each independently include a catalyst, which is used to promote 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 catalyst is included in the components of the simulated skin layer, the middle layer or the simulated fascia layer, 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 middle layer or the simulated fascia layer.

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

[0033] In addition, the present invention further provides a human face model product, which includes a base and the human face model of the present invention as described above, and the human face model is mounted on the base. When the human face model product is actually used, the human face model mounted on the base can be used for injection training; in addition, when a single injection training is completed, the used human face model can be removed from the base, and an unused human face model can be mounted on the base to facilitate the next injection training.

[0034] In this specification, if there is no special indication, the range expressed by "a small value to a large value" means that the range is greater than or equal to the small value and less than or equal to the large value. For example, the carbon number is 2 to 6, which means that the range of the carbon number can be "greater than or equal to 2 and less than or equal to 6". Simple diagram description

[0035] FIG. 1 is a schematic diagram showing the appearance of a face model of the present invention. FIG. 2 is a cross-sectional side view of the face model of the present invention. Implementation

[0036] The following examples are given to illustrate the implementation of the present invention. A person with ordinary knowledge in the relevant technical field can easily understand the advantages and effects that can be achieved by the present invention through the contents of the following examples. It should be understood that the examples listed in this specification are only used to illustrate the implementation of the present invention, and are not used to limit the scope of the present invention. A person with ordinary knowledge in the relevant technical field can make various modifications and changes based on their ordinary knowledge without departing from the spirit of the present invention to implement or apply the content of the present invention.

[0037] [Example] [1] [:Face Model] []

[0038] As shown in FIG. 1 and FIG. 2 , the face model 1 of Example 1 has a three-layer structure, which is 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 Example 1 is as follows.

[0039] Firstly, a male mold and a female mold of a simulated skin layer having a human face shape and contour are provided, and the shapes of the male mold and the female mold of the simulated skin layer correspond to each other and can be pressed together.

[0040] Next, dimethyl vinyl and trimethyl silicon dioxide (CAS No.: 68988-89-6), polydimethylsiloxane (CAS No.: 63148-62-9) and platinum catalyst are uniformly mixed to obtain a first mixed solution. Subsequently, the first mixed solution is injected into the imitation skin layer mother mold, and the imitation skin layer male mold is pressed against the imitation skin layer mother mold injected with the first mixed solution, and left to stand for about 6 hours to allow the first mixed solution to solidify to form the imitation skin layer 11, and then the imitation skin layer male mold is removed; wherein, based on the total weight of the imitation skin layer 11, the content of dimethyl vinyl and trimethyl silicon dioxide 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 Shore hardness of the simulated skin layer 11 is about 18 HA, and the light transmittance is about 94%.

[0041] Next, ethylene polydimethylsiloxane (CAS No.: 68083-19-2), hydrogen polydimethylsiloxane (CAS No.: 68037-59-2) and polydimethylsiloxane (CAS No.: 63148-62-9) are uniformly mixed to obtain a second mixed solution. Subsequently, the second mixed solution is injected onto the imitation skin layer 11, and an intermediate layer male mold is pressed on the imitation skin layer 11 injected with the second mixed solution, and the second mixed solution is allowed to stand for about 12 hours to solidify the second mixed solution to form the intermediate layer 12, and then the intermediate layer male mold is removed; wherein, 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 polydimethylsiloxane and polydimethylsiloxane is greater than or equal to 1 wt% and less than 10 wt%. The needle penetration of the intermediate layer 12 is about 240.

[0042] Next, dimethyl vinyl and trimethyl silicon dioxide (CAS No.: 68988-89-6), polydimethylsiloxane (CAS No.: 63148-62-9) and platinum catalyst are uniformly mixed to obtain a third mixed solution. Subsequently, the third mixed solution is injected onto the intermediate layer 12, and a fascia-imitation layer male mold is pressed on the intermediate layer 12 injected with the third mixed solution, and the mixture is left to stand for about 6 hours to allow the third mixed solution to solidify to form the fascia-imitation layer 13, and then the fascia-imitation layer male mold is removed; wherein, based on the total weight of the fascia-imitation layer 13, the content of dimethyl vinyl and trimethyl silicon dioxide 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 Shore hardness of the simulated fascia layer 13 is about 18 HA, and the light transmittance is about 94%.

[0043] Finally, the finished product formed by stacking the simulated skin layer 11, the middle layer 12 and the simulated fascia layer 13 in sequence is demoulded from the simulated skin layer master mold, thus obtaining the human face model 1 of Example 1.

[0044] [Test example: blunt needle puncture test] []

[0045] This test example uses the human face model of Example 1 for testing. Specifically, according to the conventional process and operation method of clinical injection therapy, a blunt needle with a size of 23G is used to contact the simulated skin layer of the human face model of Example 1 and attempt to puncture it. The test result shows that it is difficult to use the blunt needle with a size of 23G to puncture the simulated skin layer of the human face model of Example 1, which is similar to the actual human face situation. In addition, when performing injection training, a sharp needle (for example, a sharp needle with a size of 23G or 27G) can be selected to first puncture the simulated skin layer of the human face model of Example 1 at the needle insertion position, and then replaced with a blunt needle with a size of 23G to pass through the simulated skin layer; when the blunt needle with a size of 23G contacts the middle layer of the human face model of Example 1, it can easily puncture the middle layer and allow the needle body to enter it, and then the injection can be released in the middle layer, which is similar to the actual human face injection situation. Based on this, it can be seen that the face model of the present invention can indeed improve the effect of injection training.

[0046] In summary, the human face model provided by the present invention has a three-layer structure of a simulated skin layer, an intermediate layer and a simulated fascia layer, and controls the hardness or needle penetration of each layer at the same time, so that the human face model of the present invention has characteristics similar to those of a real human face, so as to provide operators with a similar feel as when injecting a real human face during injection training, thereby facilitating safer injection treatment in clinical practice.

[0047] 1: Face model 11: Skin-like layer 12: Middle layer 13: Imitation fascia layer

[0048] none.

Claims

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

2. The face model of claim 1, wherein: The needle penetration of the intermediate layer is greater than 100 and less than or equal to 300.

3. The face model as claimed in claim 2, wherein: The needle penetration of the intermediate layer is greater than 200 and less than or equal to 300.

4. The face model of claim 1, wherein: 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 of claim 1, wherein: The Shore hardness of the simulated fascia layer is greater than 0 HA and less than or equal to 30 HA.

6. The face model of claim 1, wherein: The light transmittance of the skin-like layer is greater than 90%.

7. The face model as claimed in claim 1, wherein: The maximum thickness of the middle layer is greater than or equal to 0.3 cm and less than or equal to 1.5 cm.

8. The face model of claim 1, wherein: The components of the simulated skin layer, the middle layer and the simulated fascia layer independently include silicone, plastic, rubber or a combination thereof.

9. A face model product, comprising a base and the face model as described in any one of claims 1 to 8, wherein the face model is mounted on the base.

Images