Disposable protective sleeve for preventing physical injury of oral cavity

Abstract

The invention discloses a disposable protective sleeve for preventing physical injury of an oral cavity, and belongs to the technical field of oral cavity protective articles. The protective sleeve (100) is in an ellipsoid shell shape, and a hollow containing cavity (400) inside the protective sleeve (100) is used for containing hard food to prevent the oral mucosa from making contact with the hard food; the circumferential main body wall thickness of the protective sleeve (100) is uniform, and the end part can be selectively thickened; the occlusal surface and the cheek-tongue surface are provided with symmetrically distributed through type hollow grooves (200), and the porosity is 5%-60% to balance ventilation and structure stability; the cheek side or the tongue side is provided with a through type storage groove (300), and the two ends of the through type storage groove are far away from the axial end of the protective sleeve to prevent food displacement. And the packaging bag is made of degradable TPE, medical grade soft resin or medical silica gel, meets the food contact safety standard, and is naturally degraded 30-60 days after being used. The protective sleeve is suitable for dentitions of more than 95% of people, effectively reduces the risk of oral mucosa injury, and is comfortable to wear and high in production feasibility.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of oral cavity protection products, and specifically relates to a disposable protective sleeve. The protective sleeve is specially used for blocking the direct contact between hard objects such as nuts, hard candies, and dried meats and oral mucosa when people chew the hard objects, thereby effectively preventing the oral mucosa from being scratched or poked. BACKGROUND

[0002] In the daily diet process, the oral mucosa (covering the buccal mucosa, the tongue mucosa, the gum, and the like) is damaged due to the direct contact with hard food. This problem is particularly prominent for specific groups of people, such as people with sensitive oral mucosa (including children, the elderly, patients with oral ulcer, and the like) and teenagers. Such damage to the oral mucosa is easy to cause inflammation and produce a painful and uncomfortable feeling, and even seriously affects the normal eating function.

[0003] The existing oral cavity protection products on the market have many obvious defects, specifically in the following four aspects: first, poor adaptability. Most products are designed only for a single dentition form or a single size of food, and cannot be compatible with the oral structures of different groups of people, nor can they meet the protection needs of various hard foods. Second, insufficient air permeability. Most products adopt a closed or semi-closed structure, which easily causes saliva to accumulate in the protection area, bringing discomfort to the wearer. Third, the safety of the material cannot be guaranteed. Some products use high-molecular materials that have safety risks such as excessive heavy metals and harmful leachables, and there is currently no clear standard to limit the material safety of such products. Fourth, insufficient structural stability. During chewing, the food is easy to shift axially in the protective sleeve, thereby causing the protection function to fail, and the user still faces the risk of damage to the oral mucosa caused by the contact with hard food.

[0004] Based on the above problems existing in the existing oral cavity protection products, there is an urgent need to develop a disposable oral cavity protection sleeve with wide adaptability, comfortable air permeability, safe material, and anti-shifting function, so as to fill the gap in the existing technical field. SUMMARY

[0005] (I) Invention purpose The core purpose of the present application is to provide a disposable protective sleeve for protecting the oral cavity from physical damage, specifically to achieve the following objectives: Adapt to the dentition lateral form of more than 95% of the population, and be compatible with hard foods of different sizes; Effectively block the unnecessary physical contact between food and oral mucosa, prevent the axial shift of food in the sleeve, and further reduce the risk of damage to the oral mucosa; Optimize the air permeability structure design of the product, avoid the accumulation of saliva, and improve the comfort during wearing; Clear material safety standards are established to ensure that the product is non-toxic when in contact with the mouth and can naturally degrade after use, thus balancing environmental protection and hygiene.

[0006] (II) Technical Solution To achieve the above-mentioned objectives, the technical solution adopted by this invention is as follows: A disposable protective sleeve for protecting against physical damage to the oral cavity, the core component of which is a protective sleeve (100). The protective sleeve (100) is a single integral structure, with an overall ellipsoidal shell shape, adapted to the outer curvature of the human dentition, and has a hollow internal structure for accommodating hard objects to be chewed, preventing the objects from directly contacting the oral mucosa. The circumferential wall thickness of the protective sleeve (100) is uniform, and the ends near the front and rear ends of the dentition can be thickened compared to the circumferential wall thickness, or they can be left unthickened. On the occlusal surface and buccal / lingual surface of the protective sleeve (100), there are symmetrically distributed through-hole grooves (200) along the central axis of the protective sleeve; on the buccal or lingual side of the protective sleeve (100), and below the through-hole grooves (200), there is a through-hole storage slot (300); the hollow part of the protective sleeve (100) is a hollow receiving cavity (400).

[0007] Through-hole groove (200): The through-hole groove (200) connects the inside and outside of the protective sleeve (100), allowing saliva to enter and exit the protective sleeve (100) while reducing the feeling of foreign objects during wear and improving overall wearing comfort. In terms of distribution, the through-hole groove (200) is symmetrically distributed in at least one set around the circumference of the protective sleeve (100) shell (one set of symmetrical distribution means that two grooves are mirror-symmetrical along the central axis of the protective sleeve), and arranged in at least two layers along the length of the protective sleeve in the axial direction. The through-hole grooves (200) in the same layer are evenly spaced around the circumference to ensure that the grooves are evenly distributed in the axial direction, taking into account both chewing comfort and saliva flow efficiency. The porosity of the through-hole groove (200) is 5%-60%, which is designed to balance the structural stability of the protective sleeve and the normal flow of saliva in the mouth. The porosity is calculated as the percentage of the total volume of all through-hole grooves to the solid volume of the protective sleeve, where the solid volume of the sleeve is the difference between the volume of the outer ellipsoid of the protective sleeve and the volume of the inner hollow functional cavity.

[0008] Through-type storage slot (300): The through-type storage slot (300) is a through-type structure, and its through-direction is consistent with the buccal and lingual direction of the protective sleeve (100). The two ends of the storage slot are far away from the axial ends of the protective sleeve (100). It is mainly used to put the chewed object, while avoiding axial displacement of the chewed object within the protective sleeve (100), thereby preventing additional oral contact injury caused by displacement. It should be noted that the size of the chewed object must not exceed the capacity of the protective sleeve (100).

[0009] Material Selection: The protective case (100) can be made of low-strength biodegradable thermoplastic elastomer (TPE), medical-grade soft resin (preferred), or medical-grade silicone. The TPE material must meet the following requirements: It must be made of food-contact grade TPE raw material, with heavy metal (lead, cadmium, etc.) content meeting the limits for food-contact plastics in GB 4806.7-2016 "National Food Safety Standard for Plastic Materials and Products for Food Contact," and must show no harmful leaching after immersion in simulated saliva (pH 6.8, 72 hours); its Shore A hardness must be suitable for the softness and structural support requirements of different usage scenarios; it must be able to prevent unnecessary physical contact between the chewed item and the oral mucosa and gums, retaining only the necessary occlusal contact between the item and the teeth, thereby reducing contact damage. All materials must comply with the requirements of GB 4806.7-2016 "National Food Safety Standard for Plastic Materials and Products for Food Contact" to ensure that they are non-toxic when in contact with the oral cavity and can be naturally degraded within 30-60 days after single use; and the inherent toughness of the material must ensure that it breaks in a tearing shape with no sharp edges on the fragments to avoid scratching the oral mucosa.

[0010] Adaptability design: The internal hollow structure of the protective cover (100) is designed to fit the outer shape of the dental arch of more than 95% of people, ensuring a good fit when worn, while providing ample space for chewing items of different sizes. Its internal space is the hollow cavity (400).

[0011] (III) Beneficial Effects Ultimate protection reliability: The ellipsoidal shell-shaped protective sleeve (100) and the through-type storage slot (300) with both ends away from the axial end form a double protection structure. This ensures that the food is always inside the protective sleeve, preventing it from contacting the oral mucosa. The axial limiting design of the through-type storage slot (300) also prevents the food from shifting, completely eliminating the problem of protection failure caused by shifting. This reduces the risk of oral mucosa damage by more than 95%. The thickened end structure further enhances the product's resistance to breakage and can adapt to the stress scenarios of long-term chewing.

[0012] Wide range of compatibility: The hollow cavity (400) and ellipsoidal shape design accurately fit the outer curvature of the teeth of more than 95% of people, without distinguishing between adults and teenagers (only the material hardness needs to be adjusted for sensitive people); the through-type storage slot (300) covers the width of common hard foods from 5-45mm, and is compatible with a variety of hard foods such as nuts, hard candy, dried meat, freeze-dried fruit, etc., without the need for special designs.

[0013] Comfortable and breathable to wear: The through-hole groove (200) with a porosity of 5%-60% enables rapid saliva circulation, completely avoiding the dampness, odor and stickiness caused by saliva accumulation; the low-hardness biodegradable material conforms to the soft tissue of the mouth and will not produce a stiff foreign body feeling. The comfort of wearing it for a single time can last for 2-4 hours, which can meet the wearing needs of eating meals or snacks.

[0014] Safe, environmentally friendly and hygienic: All materials strictly comply with food contact safety standards, and heavy metals and harmful leaching substances are controlled within the national standard limits, with no risk of oral irritation; adopting a single-use mode, it completely avoids cross-infection problems, and can be completely degraded in the natural environment in 30-60 days after use, without leaving plastic pollution, taking into account both hygiene and environmental protection.

[0015] High production feasibility: The product is a single integral component without complex splicing structure. The through-hole groove (200) and through-storage groove (300) and the main body can be integrated into one injection molding through a set of molds. The production efficiency is high (daily output of ≥1200 pieces per mold) and the manufacturing cost is low (cost per piece ≤0.45 yuan). It is suitable for large-scale mass production and market launch. Attached Figure Description

[0016] Figure 1: Schematic diagram of the three-dimensional structure of a disposable oral protective sleeve. It shows the ellipsoidal shell shape of the protective sleeve (100), the symmetrical distribution of the through-hole groove (200), the opening direction of the through-hole storage groove (300) (including the distance between the two ends and the axial end of the protective sleeve), and the spatial range of the hollow receiving cavity (400).

[0017] Figure 2: Schematic diagram of a partial structure of a disposable oral protective sleeve. Includes a magnified view A (10:1 magnification), which clearly shows the layered arrangement details of the through-hole groove (200), the groove size, and the end limiting structure of the through-hole storage groove (300).

[0018] Figure 3: Another perspective structural diagram of the disposable oral protective sleeve. It shows the fitting shape of the protective sleeve (100) to the outer side of the human dentition, the installation position of the through-hole (300) on the buccal or lingual side, and its relative relationship with the through-hole (200).

[0019] Figure 4: Side view of the disposable oral protective sleeve. It shows the uniform circumferential wall thickness of the protective sleeve (100), the thickness difference of the end thickened area (if any), and the distance between the through-hole storage slot (300) and the axial end of the protective sleeve.

[0020] Figure 5: Schematic diagram of the structure of a disposable oral protective sleeve. Includes a partial enlarged view of section BB (2:1 magnification) and a partial enlarged view of area C (8:1 magnification). Section BB shows the dimensional ratio of the internal hollow receiving cavity (400) to the shell body, while area C shows the through structure of the through-type storage slot (300) and the end limiting details.

[0021] The corresponding structures for each number in the diagram are as follows: 100 - protective sleeve; 200 - through-hole groove; 300 - through-hole storage groove; 400 - hollow receiving cavity. Detailed Implementation

[0022] The protective sleeve in this embodiment adopts an integrated injection molding process. The core structure includes a protective sleeve (100), a through-hole groove (200), and a through-storage groove (300). The connection relationship and functional implementation logic of each component are as follows. Unless otherwise specified, the size parameters are based on the design benchmark that adapts to the dentition morphology of 95% of the population.

[0023] (I) Overall Structure and Assembly Logic As shown in Figure 1, this protective sleeve is a single integral component without any splicing structure. The protective sleeve (100) is ellipsoidal in shape, with its outer contour strictly conforming to the outer curvature of the human dental arch. The internal hollow cavity (400) is the core housing space. The through-type hollow groove (200) is integrally formed on the occlusal surface and buccal-lingual surface of the protective sleeve (100), and is symmetrically distributed along the midline axis. The through-type storage slot (300) is opened on the buccal or lingual side, located below the through-type hollow groove (200) and penetrating through the main shell. Its two ends maintain a reasonable distance from the axial end of the protective sleeve (100). During the production process, all structures can be processed synchronously using only one set of precision injection molds, ensuring the dimensional accuracy and structural stability of each component, without the need for subsequent assembly processes.

[0024] (II) Detailed Explanation of Component Design and Correspondence with Drawings Protective sleeve (100): Wall thickness design and end reinforcement: The circumferential wall thickness of the protective sleeve (100) is uniform and consistent, ranging from 0.5 to 2.5 mm. Taking the size that fits the normal adult posterior teeth as an example, its external long axis is 45 mm and short axis is 28 mm, and the internal hollow cavity (400) has a long axis of 43 mm and a short axis of 26 mm. The main body wall thickness is 1.0 mm. This thickness can withstand biting forces of up to 70 N (covering the normal force range of adults chewing nuts), while ensuring that it is lightweight and burden-free to wear. To address the concentrated force characteristics at the anterior (incisor) and posterior (molar) ends of the dentition, the ends can be selectively thickened. As shown in Figure 4, the thickness of the thickened area at the ends is 1.5-2 times the thickness of the main body wall (1.6mm in the example). The thickened area extends 6-8mm from the ends towards the middle of the main body, forming a gradually reinforced structure to prevent end breakage during occlusion in the molar area. If used for children or individuals with extremely sensitive oral mucosa, the ends can be left unthickened, and the overall wall thickness of the main body can remain uniform (0.5-0.8mm) to reduce the risk of mucosal irritation.

[0025] Through-type hollow groove (200): Distribution logic and structural parameters: As shown in Figure 2 and partial enlarged view A (enlargement ratio 10:1), the through-type hollow groove (200) is a fully through-type structure with smooth and burr-free groove walls, ensuring unobstructed saliva flow without scratching oral tissues. Its arrangement strictly follows the principle of "axial layering and circumferential equidistant spacing": 2-15 layers are set along the length of the protective sleeve axially, and the circumferential spacing between adjacent hollow grooves in the same layer is 5-10mm; the groove width is 1.0-3.5mm, which ensures air permeability without weakening the shell strength. As shown in the enlarged view of the BB section in Figure 5 (enlargement scale 2:1), the opening direction of the through-type hollow groove (200) is perpendicular to the protective sleeve shell. The porosity of all the hollow grooves is 5%-60%. The calculation basis is "total volume of hollow grooves ÷ solid volume of protective sleeve shell" (solid volume of shell = volume of outer ellipsoid of protective sleeve - volume of inner hollow cavity). This range can achieve the optimal balance between saliva flow rate and structural stability.

[0026] Through-type storage slot (300): Anti-displacement design and dimensional parameters: As shown in the enlarged view of area C in Figures 3 and 5 (enlargement ratio 8:1), the through-type storage slot (300) is a through-type structure, with the through direction consistent with the cheek and tongue direction of the protective sleeve (100). The slot width is 0.2-3mm, and the slot depth is the shell thickness of the protective sleeve (100) because the slot is through-type. The slot length is 10-25mm, which can accommodate hard foods of different sizes. Its core design highlight is that "both ends are far away from the axial end of the protective sleeve": the axial length of the through-type storage slot (300) is 40%-60% of the axial length of the main body of the protective sleeve, and the distance between the two ends and the axial end of the protective sleeve is 5-12mm, forming an axial limiting structure, which effectively prevents the food from shifting back and forth in the hollow cavity (400) during chewing, and completely eliminates mucosal contact damage caused by displacement.

[0027] (III) Function Implementation and Usage Scenarios The protective and anti-displacement functions are achieved synergistically: During use, hard foods (such as nuts with a diameter of 8mm or hard candies with a length of 30mm) are placed into the hollow receiving cavity (400) and positioned through the through-hole storage slot (300). The food is constrained by the end limiting structure of the through-hole storage slot (300) and cannot move along the axial direction of the protective sleeve; at the same time, the ellipsoidal shell shape of the protective sleeve (100) fits the outer side of the dentition, forming a closed protective space. The food can only contact the teeth for chewing and does not come into physical contact with the buccal mucosa, lingual mucosa, or gums, reducing the risk of injury by more than 95%. Even during vigorous chewing, the wall thickness design of the main body of the protective sleeve and the end reinforcement structure can prevent deformation and ensure the stability of the protective space.

[0028] Breathability adapts to different usage needs: The porosity of the through-hole groove (200) can be flexibly adjusted according to the usage scenario. For people with excessive saliva secretion (such as children, when eating spicy food), a high porosity of 40%-60% is selected, with 5 layers of hollow grooves in the axial direction and a circumferential spacing of 5-7mm, so that the saliva flow rate can reach 8-10mL / min, completely avoiding stagnation; for people with dry or sensitive mouths, a low porosity of 5%-20% is selected, with 3 layers of hollow grooves in the axial direction and a circumferential spacing of 8-10mm, which improves structural stability while ensuring basic breathability and reducing airflow irritation to the mucous membrane.

[0029] (iv) Variations and Optimization Directions The core structure of this invention can be slightly adjusted according to the usage scenario, but it still falls within the scope of protection: Material replacement: Under the premise of complying with GB 4806.7-2016 standard, medical grade soft resin can be replaced with food contact grade TPE or medical silicone of the same hardness. Only the injection temperature and pressure parameters of the corresponding material need to be adapted, without changing the structural dimensions.

[0030] Hollowed-out groove arrangement: The axial "parallel layering" can be adjusted to "staggered layering", with adjacent grooves being staggered and not overlapping, further improving the shell strength.

[0031] The location of the through-hole storage slot (300) can be selectively opened on the cheek side or the tongue side according to usage habits. For children's models, the cheek side is preferred to avoid irritating the tongue mucosa.

[0032] Size adjustment: Without deviating from the core parameter range, the axial length of the protective sleeve and the spacing of the through-type storage slot (300) can be adjusted within ±10% to adapt to special dental arch morphology (such as orthodontic patients).

[0033] (v) Correlation between material selection and safety verification The material of this protective case must meet three requirements: food contact safety, biodegradability, and adaptability. For typical adult applications: Medical-grade soft resin (Shore A hardness 45-70 degrees) is preferred. It is easy to process and mold, has a degradation cycle of 35-50 days, and has a significant cost advantage, making it suitable for large-scale mass production.

[0034] For sensitive individuals / infants: Choose medical-grade silicone (Shore A, hardness 35-45 degrees), which has the best biocompatibility, no risk of mucosal irritation, and a degradation period of 40-60 days.

[0035] For economical scenarios: Choose low-strength biodegradable TPE (Shore A hardness 30-70 degrees). Sensitive people should choose 30-45 degrees, and general people should choose 45-70 degrees. The elongation at break should be ≥100%, and the degradation period should be 30-60 days.

[0036] All materials must pass rigorous safety verification: heavy metal testing (lead ≤1.0mg / kg, cadmium ≤0.1mg / kg), simulated saliva immersion test (pH 6.8, no harmful leaching after 72 hours), and mucosal irritation test (no redness, swelling, or itching reaction) to ensure absolute safety for oral contact.

[0037] Those skilled in the art should understand that the above embodiments are merely illustrative examples, and any minor adjustments to the structural dimensions or optimizations to the processing technology without departing from the technical principles of this invention are within the scope of protection of this invention.

Claims

1. A disposable protective sleeve for protecting against physical injuries to the oral cavity, characterized in that, Includes a protective sleeve (100); the protective sleeve (100) is a single integral component, and the whole is ellipsoidal shell shape adapted to the outer curvature of the human dentition. The interior is hollow and is used to accommodate hard objects to be chewed, so as to prevent them from directly contacting the oral mucosa; the circumferential wall thickness of the protective sleeve (100) is uniform, and the ends near the front and rear ends of the dentition are thickened compared to the circumferential wall thickness, or the thickness can be left unadded; the occlusal surface and buccal and lingual surfaces of the protective sleeve (100) are symmetrically distributed with through-hole grooves (200) along the central axis of the protective sleeve; a through-hole storage slot (300) is provided on the buccal or lingual side of the protective sleeve (100) and below the through-hole groove (200); the hollow part of the protective sleeve (100) is a hollow receiving cavity (400).

2. The protective sleeve according to claim 1, characterized in that, The through-hole groove (200) enables communication between the inside and outside of the protective cover (100), allowing oral saliva to enter and exit the protective cover (100), while reducing the feeling of foreign objects when wearing it and improving the overall wearing comfort.

3. The protective sleeve according to claims 1-2, characterized in that, The through-hole grooves (200) are symmetrically distributed in at least one set around the protective sleeve (100) shell. A set of symmetrical distribution means that two grooves are mirror-symmetrical along the central axis of the protective sleeve and are arranged in at least two layers along the length of the protective sleeve in the axial direction. The through-hole grooves (200) in the same layer are evenly distributed in the circumferential direction to ensure that the grooves are evenly distributed in the axial direction, taking into account both chewing comfort and saliva flow efficiency.

4. The protective sleeve according to claims 1-3, characterized in that, The porosity of the through-hole groove (200) is 5%-60%, which is designed to balance the structural stability of the protective sleeve with the normal flow of saliva in the mouth. The porosity is calculated as the percentage of the total volume of all through-hole grooves to the volume of the protective sleeve shell, wherein the volume of the shell shell is the difference between the volume of the outer ellipsoid of the protective sleeve and the volume of the inner hollow functional cavity.

5. The protective sleeve according to claims 1-4, characterized in that, The protective sleeve (100) is made of low-strength biodegradable thermoplastic elastomer (TPE), medical-grade soft resin (preferred), or medical-grade silicone. The TPE material must meet the following requirements: food-contact grade TPE raw materials must be used, and the content of heavy metals (lead, cadmium, etc.) must comply with the limits for food-contact plastics in GB 4806.7-2016 "National Food Safety Standard for Plastic Materials and Products for Food Contact," and there must be no harmful leaching after simulating saliva immersion (pH 6.8, 72 hours); the Shore A hardness must be adapted to the softness and structural support requirements of different usage scenarios; it must be able to block unnecessary physical contact between the chewed item and the oral mucosa and gums, retaining only the necessary occlusal contact between the item and the teeth, thereby reducing contact damage; and all materials must comply with GB... The National Food Safety Standard 4806.7-2016, "Plastic Materials and Products for Food Contact," requires that the materials be non-toxic to the oral cavity and degrade naturally within 30-60 days after single use. The inherent toughness of the material ensures that it breaks in a tearing shape with no sharp edges on the fragments, thus avoiding scratching the oral mucosa.

6. The protective sleeve according to claims 1-5, characterized in that, The two ends of the through-type storage groove (300) are far from the axial ends of the protective sleeve (100) to prevent the chewed object from shifting axially.

7. The protective sleeve according to claims 1-6, characterized in that, The internal hollow structure of the protective sleeve (100) is designed to fit the outer shape of the dental arches of more than 95% of the population, ensuring a good fit when worn, while providing ample space for chewing items of different sizes.

8. The protective sleeve according to claims 1-7, characterized in that, The hollow cavity (400) is the internal accommodating space of the protective sleeve (100).

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