Gingival protecting device for invisible orthodontics and medical instrument thereof

Abstract

A gingiva protecting device for invisible orthodontics comprises a fixed seat, an assembly part and an isolation part. The fixed seat is connected with the invisible orthodontic appliance, and the assembly part is movably assembled with the fixed seat. One end of the isolation piece is arranged on the assembly piece, and the other end extends towards the gingiva to establish an isolation space or is shortened away from the gingiva to remove the isolation space. According to the gingiva protecting device, the telescopic adjustable and detachable gingiva protecting accessory is adopted, and the traction component (such as a rubber band) is prevented from being in direct contact with the gingiva through a physical isolation structure, so that the gingiva is prevented from being pressed and damaged fundamentally, meanwhile, the oral cavity cleaning convenience is improved, food residue accumulation and bacterial plaque breeding are reduced, and the treatment comfort and oral cavity health are guaranteed. As a medical instrument, the device is matched with an oral appliance to be used, gingival compression complications in invisible orthodontics are avoided, gingival health is kept, and treatment experience is improved.

Description

Technical Field

[0001] This invention relates to a dental instrument, and more particularly to a device for protecting the gums during orthodontic treatment, and the same as a medical device. Background Technology

[0002] Invisible aligners are personalized orthodontic devices made from medical-grade transparent polymer materials. The corrective force they generate often requires the assistance of traction components such as elastic bands to guide the teeth gradually and achieve the desired alignment. Gingival compression is a relatively common complication of invisible orthodontics, especially under intramaxillary traction. Traction elastic bands and other such devices may directly contact the gum tissue, and the continuous mechanical pressure can easily lead to adverse reactions such as redness, swelling, pain, or erosion of the gums. At the same time, oral hygiene is more difficult during orthodontic treatment. If the aligner attachments are fixed and not easily removable, food debris can easily accumulate, increasing the risk of plaque growth and further affecting gum health and the treatment experience.

[0003] Because the traction position of rubber bands is flexible, the contact area between them and the gums dynamically changes with the adjustment of the traction position. In practice, rubber bands often end up directly adhering to the gum surface. Furthermore, existing orthodontic appliances lack dedicated gum protection design in their traction attachments, and most are fixed, non-removable structures. This neither fundamentally solves the problem of direct contact between the rubber band and the gums nor allows for flexible assembly and disassembly according to clinical treatment needs. During treatment, when cleaning the attachments, the fixed structure easily traps food debris, increasing the difficulty of oral hygiene. Moreover, the fixed position and shape of the attachments prevent flexible adjustment of the relative distance to the gums based on individual patient differences in gum morphology and dynamic positional changes during tooth movement, making it difficult to provide targeted gum protection. Summary of the Invention

[0004] One object of the present invention is to provide a gingival protection device for invisible orthodontics, which establishes an isolation zone to prevent the gingiva from being compressed by traction components (such as rubber bands) during invisible orthodontics, thus preventing gingival compression complications.

[0005] Another object of the present invention is to provide a gingival protection device for invisible orthodontics, which is used in conjunction with invisible aligners to improve the flexibility of orthodontic treatment in protecting the gums.

[0006] Another objective of this invention is to provide a gum protection device for invisible orthodontics that is easy to assemble and disassemble, avoids discomfort to oral tissues, and improves the safety of invisible orthodontics.

[0007] A gum protection device for invisible orthodontics, including

[0008] The mounting bracket, which connects to the clear aligner, such as by adhesive;

[0009] An assembly component that is movably assembled with a fixed base;

[0010] An isolator is attached to the assembly at one end and extends toward the gum line to create an isolation space, or shortens away from the gum line to remove the isolation space.

[0011] Another type of gum protection device used for invisible orthodontics includes

[0012] The fixing base includes a first end and a second end, the first end being connected to the clear aligner, such as by bonding, and the second end floating on the surface of the clear aligner.

[0013] An assembly component that is movably assembled with a fixed base;

[0014] An isolator is attached to the assembly at one end and extends toward the gum line to create an isolation space, or shortens away from the gum line to remove the isolation space.

[0015] After the isolation space is established, the traction component (such as a rubber band) applies force to the isolation element, eliminating the pressure on the gums.

[0016] Depending on the orthodontic treatment, when the traction component (such as a rubber band) releases the force applied to the isolator, the space away from the gum shortens and the isolator is removed, restoring the original appearance of the environment of each tissue in the oral cavity.

[0017] An assembly is placed between the first and second ends to facilitate the assembly of the fixation base and the assembly, reduce the height of the fixation base to avoid irritating the surrounding mucosa, and reduce the patient's foreign body sensation.

[0018] The gingival protection device for invisible orthodontics provided by this invention is a medical device used in conjunction with oral appliances to avoid gingival compression complications during invisible orthodontics, maintain gingival health, and improve the treatment experience.

[0019] The gingival protection device for invisible orthodontics provided by this invention adopts a telescopic and detachable gingival protection attachment. Through a physical isolation structure, it prevents traction components (such as rubber bands) from directly contacting the gums, thereby avoiding gum pressure damage from the root cause. At the same time, it improves the convenience of oral cleaning, reduces the accumulation of food debris and plaque growth, and ensures treatment comfort and oral health.

[0020] The precise adjustment of the telescopic height of the gingival protection device and its self-locking fixation meet the dynamic adaptation needs of different patients' oral anatomy and tooth movement processes. It is also compatible with individuals with narrow oral vestibules and can be flexibly installed or removed according to the clinical treatment stage (e.g., enhanced protection is needed during the critical period of tooth movement, and the structure can be simplified during the maintenance period), thus improving its clinical applicability.

[0021] The gingival protection device is compact in structure and streamlined in overall size, avoiding irritation to surrounding oral tissues. The option to equip it with an isolator can be flexibly selected based on treatment needs. When the isolator is not needed, the remaining fixation seat also does not irritate oral tissues, balancing gingival protection, clinical flexibility, and functional practicality. Attached Figure Description

[0022] Figure 1 This is a schematic diagram of the structure of an embodiment of the gum protection device of the present invention;

[0023] Figure 2 This is an enlarged structural schematic diagram of the fixing seat of the gum protection device of the present invention at one angle;

[0024] Figure 3 This is a schematic diagram of the structure of the gingival protection device of the present invention fixed at one angle to the orthodontic appliance;

[0025] Figure 4 This is a partially enlarged schematic diagram of the fixing base and assembly of the gum protection device of the present invention at an angle before assembly;

[0026] Figure 5 This is a schematic diagram of an embodiment of the gingival protection device of the present invention, which blocks the traction component. Detailed Implementation

[0027] The technical solution of the present invention will be described in detail below with reference to the accompanying drawings. The embodiments of the present invention are only used to illustrate the technical solution of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solution of the invention without departing from the spirit and scope of the technical solution of the present invention, and all such modifications and substitutions should be covered within the scope of the claims of the present invention.

[0028] Figure 1 This is a schematic diagram of the structure of an embodiment of the gum protection device of the present invention. Figure 2 This is an enlarged structural schematic diagram of the fixing base of the gum protection device of the present invention at one angle. Figure 3 This is a schematic diagram showing the structure of the gingival protection device of the present invention fixed at one angle to the orthodontic appliance. (See diagram below.) Figure 1 , Figure 2 and Figure 3 As shown, the gum protection device 10 of this embodiment includes a fixing base 100, an assembly 200, and an isolating member 300. The fixing base 100 is fixed to the invisible aligner 20, and the isolating member 300 is disposed on the assembly 200. After the assembly 200 is assembled to the fixing base 100, a force is applied to the isolating member 300 (e.g., ...). Figure 1 The upper end of the angle shown causes the separator 300 to extend toward the gingiva 40 to create an isolation space 30.

[0029] The fixing base 100 includes a first end 110 and a second end 120. The first end 110 is connected to the clear aligner by means of bonding, fastening, threading or plugging, so that the fixing base is fixed to the clear aligner. At the same time, when viewed from the outside, the second end can be seen floating on the surface of the clear aligner.

[0030] The first end 110 does not have a real volume; for example, it is merely a surface on the fixation base, the geometric surface where it connects to the clear aligner. The second end is arranged opposite to the first end in space and is also the main part that constitutes the fixation base.

[0031] The fixation base 100 is injection molded (or 3D printed in one piece) from medical-grade TPU material and is movably assembled with the assembly 200 using methods such as bonding, snap-fitting, threading, or plugging. This allows the assembly to be easily and securely mounted on the fixation base, for example, precisely fitting to achieve circumferential limiting and prevent rotational displacement. Furthermore, it facilitates easy disassembly and separation from the fixation base, improving the flexibility of the device and allowing for the application of the device and its required quantity and arrangement according to the actual needs of the traction components in invisible orthodontics.

[0032] An assembly, such as threads, adhesive, or mounting groove, is provided between the first end 110 and the second end 120. This not only makes the assembly of the fixation base and the assembly more secure but also helps to reduce the height of the second end floating on the surface of the clear aligner and the volume of the second end 120, reducing discomfort to oral tissues and improving the safety of clear orthodontics. With the mounting groove between the first and second ends, the second end is observed to float above the surface of the clear aligner.

[0033] Figure 4 This is a partially enlarged schematic diagram of the fixing base and assembly of the gum protection device of the present invention at an angle before assembly. See also... Figure 1 and Figure 2 ,like Figure 4As shown, the assembly groove 130 is located on the outer edge between the first end 110 and the second end 120. Its shape is annular or arc-shaped, with a depth of 1.2 mm. Along the longitudinal direction of the groove, it includes a guide area 131 and a fastening area 132. The fastening area is near the bottom of the groove, and the guide area is located at the groove opening (width: 0.45 mm). From the groove opening, the width of the guide area gradually narrows, resembling a trumpet, until it enters the fastening area, where the width no longer changes, and the groove cross-section presents a "Y" layout. The inner cavity width of the fastening area is 0.2 mm, which mates with the assembly edge 220 of the assembly component (gap ≤ 0.05 mm), achieving precise fitting, circumferential limiting, increasing the assembly's firmness, and ensuring the total height of the fixing seat is 2 mm ± 0.03 mm, avoiding excessive occupation of oral space and reducing irritation to the surrounding mucosa. During disassembly, a slight pull along the axial direction of the assembly edge will disengage the protruding edge from the groove, separating the component from the base. The operation is convenient, and patients can perform daily disassembly and cleaning themselves.

[0034] The assembly also includes an assembly eaves 210, with an assembly ridge 220 disposed at the eaves end of the assembly eaves 210. The assembly eaves 210 bends to enclose one end (e.g., the second end) of the fixing seat. During this process, the assembly ridge is first placed in the fastening area via the guide area and then assembled with the assembly groove. During disassembly, a slight pull on the assembly ridge (e.g., axially) will disengage the assembly ridge from the assembly groove, thus separating the assembly from the fixing seat. The operation is convenient, and patients may be able to perform daily disassembly and cleaning themselves.

[0035] The isolator is made of medical-grade PPSU material, featuring a retractable, hollow, flat structure with three nested sleeves (each sleeve has a width of 3mm, 2mm, and 1mm from the outside in, corresponding to thicknesses of 2mm, 1.5mm, and 1mm respectively). Its compact size minimizes irritation to oral tissues. One end of the sleeve is integrally injection-molded with the assembly or inserted into it. The inner wall of the isolator has evenly distributed slots at 1mm intervals (each slot is 0.3mm deep) along the axial direction, covering a complete adjustment range of 0-6mm. This allows for precise adaptation to different traction heights and the position of the oral vestibule, ensuring targeted protection of the gums and preventing direct pressure from the rubber band on the mucosa during traction. Furthermore, its detachable design allows patients to remove the component during eating and cleaning, thoroughly cleaning the base and interdental spaces, reducing food debris accumulation and the risk of plaque growth.

[0036] In application, the first end is first connected to the clear aligner, fixing the retainer to the aligner, while the second end floats on the surface of the clear aligner. Several retainers are distributed on the outer side of the crown (i.e., the side in contact with the inner labial or intrafacial mucosa), for example, distributed in different positions on the same crown, or one retainer for each crown, or partial crown placement, etc. Then, the assembly is fitted onto the retainers. The assembly may have a pre-installed or fitted isolator, or one end of the isolator may be attached to the assembly after it has been fitted onto the retainer. Applying a force (e.g., tension) to the other end of the isolator causes it to elongate towards the gum line, creating an isolation space around the gum line (e.g., 1-3 mm between the gum line and the outer edge of the isolator), preventing the traction component from touching the gum line at that point. Alternatively, applying a force shortens the isolator around the gum line, moving it away from the gum line, thus removing the isolation space and restoring the proper tissue environment, positional relationship, and contact relationship around the gum line.

[0037] Figure 5 This is a schematic diagram of an embodiment of the blocking and traction component of the gum protection device of the present invention. (In conjunction with...) Figure 1 ,like Figure 5 As shown, the telescopic adjustment function of the isolator 300 allows the traction component 50, located at different positions or heights, to directly contact the isolator 300, maintaining a safe distance of 1-3mm between the gums and effectively avoiding the risk of the traction component directly compressing the gums. Simultaneously, the detachable design allows for quick separation of the components from the base, enabling patients to directly clean the tooth surfaces and gaps around the base during cleaning, reducing food debris residue, effectively reducing plaque growth, and lowering the incidence of gingivitis, thus balancing gum protection and oral hygiene needs. Therefore, the device in this embodiment achieves dual protection of oral health: "safe gum protection" and "convenient cleaning."

[0038] The mounting base and assembly components are assembled using a slot-type design, allowing for height adjustment with a precision of 1mm. This accommodates oral anatomical differences in vestibule depth (1-6mm) and dynamically responds to positional changes during tooth movement. It also supports flexible installation or removal based on clinical treatment stages—assembling the component during critical tooth movement phases to enhance gingival protection, and removing it during treatment maintenance to simplify intraoral structure, thus balancing usage needs and patient experience at different stages. This achieves the dual goals of "precise adjustment" and "flexible assembly / disassembly," adapting to dynamic clinical requirements.

[0039] The device in this embodiment features a simple and compact overall structure (total weight of accessories ≤ 0.5g), with few components, preserving the transparent and aesthetically pleasing nature of the appliance. The small size of the fixation base (total height 2mm) avoids irritating the surrounding mucosa, reducing the patient's foreign body sensation. Assembly and disassembly require no tools, only slight manual force, and cleaning after disassembly is convenient. Furthermore, when gingival protection is not needed, only the fixation base is retained, reducing the structural load on the oral cavity and allowing the patient to maintain a comfortable wearing position even when not under protection, balancing functional needs and patient experience. Therefore, the device in this embodiment also features "simplified design" and "user-friendly operation," effectively improving the treatment experience.

Claims

1. A gum protection device for invisible orthodontics, characterized in that... include A fixed base that connects to the invisible aligner; An assembly that is movably assembled with the aforementioned fixed base; An isolator is attached to the assembly at one end and extends toward the gum line to create an isolation space, or shortens away from the gum line to remove the isolation space.

2. The gingival protection device for invisible orthodontics according to claim 1, characterized in that... The fixing base includes a first end and a second end, the first end being connected to the clear aligner, and the second end floating on the surface of the clear aligner.

3. The gingival protection device for invisible orthodontics according to claim 2, characterized in that... An assembly is placed between the first and second ends and connected to the assembly component.

4. The gingival protection device for invisible orthodontics according to claim 2, characterized in that... An assembly groove is provided between the first end and the second end. The assembly groove is arranged on the outer edge between the first end and the second end and includes a guide area and a fastening area along the depth direction of the groove. The fastening area is close to the bottom surface of the groove, and the guide area is located at the opening of the groove.

5. The gingival protection device for invisible orthodontics according to claim 4, characterized in that... From the opening of the groove, the width of the guide area gradually converges, resembling a trumpet mouth, until it enters the fastening area, where the width no longer changes, and the groove cross-section presents a "Y" layout.

6. The gingival protection device for invisible orthodontics according to claim 4, characterized in that... The groove width of the fastening area is 0.2 mm.

7. The gingival protection device for invisible orthodontics according to claim 4, characterized in that... The depth of the assembly groove is 1.2 mm.

8. The gingival protection device for invisible orthodontics according to claim 1, characterized in that... The assembly also includes an assembly eaves, which are curved to wrap around one end of the fixing seat, and an assembly ridge is provided at the eaves end of the assembly eaves.

9. The gingival protection device for invisible orthodontics according to claim 8, characterized in that... The total height of the fixing base is 2mm ± 0.03mm, including a first end and a second end. The first end is connected to the clear aligner, and the second end floats on the surface of the clear aligner. An assembly groove is provided between the first end and the second end. The assembly groove is arranged on the outer edge between the first end and the second end, and includes a guide area and a fastening area along the longitudinal direction of the groove. The fastening area is close to the bottom surface of the groove, and the guide area is located at the opening of the groove. The assembly ridge is assembled to the fastening area.

10. A medical device, characterized in that... Includes the gingival protection device for invisible orthodontics as described in claim 1.

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