A tray for taking impressions of infants with cleft lip and palate

Abstract

The utility model provides a kind of cleft lip and palate infant impression taking tray, it is related to impression taking tray technical field, comprising: tray body, tray body includes bottom plate, the middle part of one end of bottom plate is provided with the protruding palatal boss, the both sides of one end of bottom plate are provided with rear edge positioning baffle in palatal boss, the periphery of bottom plate is provided with the side edge support wing connected with two rear edge positioning baffle, the middle part of the other end of bottom plate is provided with the liftable nasolabial sulcus adaptation boss;Pressure sensor, pressure sensor is set on the upside of bottom plate, palatal boss and nasolabial sulcus adaptation boss;Solve the problem that traditional tray is difficult to be applicable to the impression taking of cleft lip and palate infant in prior art.

Description

Technical Field

[0001] This utility model belongs to the field of impression making tray technology, and more specifically, relates to an impression making tray for infants with cleft lip and palate. Background Technology

[0002] Cleft lip and palate is a common congenital craniofacial malformation, presenting as a maxillary cleft, alveolar arch fracture, and nasal alar collapse at birth. To reduce preoperative jawbone tension, guide bone growth, and prevent postoperative recurrence and scar formation, nasopalatine braces are commonly used for early non-surgical intervention in clinical practice. The design and customization of these braces rely on complete impressions of the infant's oral and nasal regions to obtain high-fidelity tissue boundary information, including key areas such as the nasal alar, nasal floor, columella, alveolar bone, and palate.

[0003] However, the impression trays widely used in clinical practice at present are designed based on the jawbone structure of normal infants and lack adaptability to the maxillofacial cleft characteristics of children with cleft lip and palate. Due to congenital maxillary clefts, these children have abnormal jawbone position and increased width, and their nasal tissue structure also differs significantly from normal anatomy. Traditional trays are difficult to effectively cover and fit the structure, especially in the nasal area. The geometry of the front end of the tray cannot cover the spatial structure of the nasal alar and columella, resulting in problems such as incomplete tissue coverage, shape deformation, and even collapse during the impression process.

[0004] Furthermore, due to the low compatibility between the tray and the infant's oral anatomy, the person taking the impression often needs to repeatedly try to adjust the tray position or make manual adjustments during the impression-taking process, and sometimes even a custom-made tray is required for each individual. This not only significantly prolongs the impression-taking time and increases the workload of the medical procedure, but also exacerbates the infant's discomfort and makes cooperation more difficult. Infants are prone to crying, choking, or even aspiration during the impression-taking process, which seriously affects the quality of the impression, increases medical risks, and also brings considerable psychological stress to the child's family.

[0005] More importantly, due to incomplete or deformed impression structures, the resulting nasal and palatal trays often deviate in nasal positioning, leading to poor fit and decreased stability. This necessitates additional adjustments or re-fabrication after the impression is taken, affecting treatment outcomes and prolonging the treatment period. Furthermore, traditional trays are mostly disposable and cannot be sterilized or reused. The need for multiple impression attempts significantly increases medical consumable costs and environmental burden, limiting their widespread application in primary care or high-burden medical institutions. Utility Model Content

[0006] The purpose of this invention is to address the shortcomings of existing technologies by providing a tray for taking impressions of infants with cleft lip and palate, thus solving the problem that traditional trays are not suitable for taking impressions of infants with cleft lip and palate.

[0007] To achieve the above objectives, this utility model provides a tray for taking impressions of infants with cleft lip and palate, comprising: The tray body includes a base plate, a raised palatal protrusion is provided at the center of one end of the base plate, a rear edge positioning baffle is provided on both sides of the palatal protrusion at one end of the base plate, a side edge support wing is provided on the outer periphery of the base plate and connected to the two rear edge positioning baffles, and a liftable nasolabial groove adapter protrusion is provided at the center of the other end of the base plate. A pressure sensor is disposed on the upper side of the base plate, the palatal protrusion, and the nasolabial groove adapter protrusion.

[0008] Optionally, a handle is detachably connected to the other outer end of the base plate.

[0009] Optionally, the palatal protrusion has an arched structure, and the surface of the palatal protrusion is provided with multiple recessed guide portions.

[0010] Optionally, the edge of the side support wing is provided with an outward-curled edge structure, and the outer side of the rolled edge structure is covered with a cushioning pad.

[0011] Optionally, the nasolabial groove adapter protrusion has a wedge-shaped structure, with the end away from the palatal protrusion being higher than the end close to the palatal protrusion, and the side edge support wing is guided and engaged with the end of the nasolabial groove adapter protrusion away from the palatal protrusion.

[0012] Optionally, the upper side of the base plate is provided with a lifting groove that mates with the nasolabial groove adapter boss. Part of the nasolabial groove adapter boss is slidably disposed in the lifting groove. The nasolabial groove adapter boss is connected to the bottom of the lifting groove through an adjusting screw. The adjusting screw is exposed from the lower side of the base plate to form an operating end.

[0013] Optionally, the pressure sensor includes multiple piezoresistive films, which are arranged in an array.

[0014] Optionally, an expansion layer is provided on the upper side of the pressure sensor. The expansion layer is made of polycaprolactone and covers the upper surface of the tray body. An antibacterial coating is provided on the upper side of the expansion layer.

[0015] This utility model provides a tray for taking impressions of infants with cleft lip and palate. Its advantages are as follows: A palatal protrusion is provided at the center of the palatal side of the rear end of the tray body's base plate to support and guide the flow of the impression material. Rear edge positioning baffles are provided on both sides of the palatal protrusion at the rear end of the base plate, connecting with side edge support wings to form a limiting structure, preventing the tray from sliding backward. Side edge support wings are provided at the front end and both sides of the base plate to support the palatal margin and buccal mucosa area, improving the tray's stability. A nasolabial groove fitting protrusion is provided at the center of the cleft side of the front edge of the base plate, covering the nasal alae, nasal floor, and columellar region. This device achieves comprehensive coverage and precise impressions of the nasal alar, nasal floor, columella, alveolar bone, and palate tissues in children with cleft lip and palate, significantly improving the quality of model preparation and optimizing the precision of subsequent orthodontic appliance fabrication. Pressure sensors are installed on the base plate, palatal protrusion, and nasolabial groove fitting protrusion to provide feedback on the pressure distribution during the impression process. The nasolabial groove fitting protrusion is height-adjustable, facilitating the adjustment and optimization of impression quality in key areas based on pressure conditions. The tray for taking impressions of infants with cleft lip and palate is height-matched to the maxillofacial structure of these children, possessing excellent tissue coverage and nasal support characteristics, thereby improving the integrity of the impression and operational efficiency.

[0016] Other features and advantages of this invention will be described in detail in the following detailed description section. Attached Figure Description

[0017] The above and other objects, features and advantages of the present invention will become more apparent from the accompanying drawings, in which like reference numerals generally represent like parts.

[0018] Figure 1 A schematic diagram of a tray for taking impressions of infants with cleft lip and palate according to Embodiment 1 of this utility model is shown.

[0019] Explanation of reference numerals in the attached figures: 1. Handle; 2. Side support wing; 3. Nasolabial groove adapter boss; 4. Base plate; 5. Palatal boss; 6. Rear edge positioning baffle; 7. Pressure sensor. Detailed Implementation

[0020] Preferred embodiments of the present invention will now be described in more detail. While preferred embodiments of the present invention are described below, it should be understood that the present invention can be implemented in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided to make the present invention more thorough and complete, and to fully convey the scope of the present invention to those skilled in the art.

[0021] like Figure 1As shown, this utility model provides a tray for taking impressions of infants with cleft lip and palate, comprising: The tray body includes a base plate 4. A raised palatal protrusion 5 is provided in the middle of one end of the base plate 4. Rear edge positioning baffles 6 are provided on both sides of the palatal protrusion 5 at one end of the base plate 4. Side edge support wings 2 connected to the two rear edge positioning baffles 6 are provided on the outer periphery of the base plate 4. A liftable nasolabial groove adapter protrusion 3 is provided in the middle of the other end of the base plate 4. Pressure sensor 7 is located on the upper side of base plate 4, palatal protrusion 5 and nasolabial groove adapter protrusion 3.

[0022] Specifically, to address the problem that traditional trays are unsuitable for impression taking in infants with cleft lip and palate, this invention provides an impression taking tray for infants with cleft lip and palate. A palatal protrusion 5 is provided at the center of the rear palatal side of the base plate 4 of the tray body to support and guide the flow of the impression material. Rear edge positioning baffles 6 are provided on both sides of the palatal protrusion 5 at the rear end of the base plate 4, connecting with the side edge support wings 2 to form a limiting structure, preventing the tray from sliding backward. Side edge support wings 2 are provided at the front end and both sides of the base plate 4 to support the palatal margin and buccal mucosa area, improving tray stability. A nasolabial groove fitting protrusion 3 is provided at the center of the cleft side of the front edge of the base plate 4, covering the nasal wing, The nasal base and columella area achieve comprehensive coverage and precise impression of the nasal alar, nasal base, columella, alveolar bone, and palate tissues of children with cleft lip and palate, significantly improving the quality of model making and optimizing the precision of subsequent orthodontic appliance fabrication. Pressure sensors 7 are installed on the base plate 4, palatal protrusion 5, and nasolabial groove adapter protrusion 3 to provide feedback on the pressure distribution during the impression process. The nasolabial groove adapter protrusion 3 is height-adjustable, facilitating the adjustment and optimization of the impression quality in key areas based on the pressure conditions at that location. The height of this impression-making tray for cleft lip and palate infants is matched to the maxillofacial structure of cleft lip and palate infants, providing good tissue coverage and nasal support characteristics, which can improve the integrity of the impression and operational efficiency.

[0023] Optionally, a handle 1 is detachably connected to the outer side of the other end of the base plate 4.

[0024] Specifically, the detachable handle 1 is located at the center of the front end of the tray body, facing outwards, and can be vertically connected to its outer surface to guide the placement direction and angle of the tray in the oral cavity, making it easy for the impression taker to quickly position it; the detachable design of the handle 1 allows it to adapt to the operating habits of different medical staff.

[0025] Furthermore, the detachable connection structure can adopt a plug-in structure or a snap-fit ​​structure.

[0026] Optionally, the palatal protrusion 5 has an arched structure, and the surface of the palatal protrusion 5 is provided with multiple recessed guide portions.

[0027] Specifically, the recessed guide portion can be a hole or a groove. The recessed guide portion on the upper surface of the palatal boss 5 can accommodate part of the impression material, guide the impression material into the hole or groove of the palatal boss 5, guide the impression material to flow in multiple directions and prevent collapse or accumulation.

[0028] In this embodiment, the palatal protrusion 5 features a multi-level flow guiding design, with an arched, layered honeycomb structure that can be easily 3D printed. It supports the impression material and guides its flow. The layered holes guide the multi-directional flow of the impression material, preventing collapse and enhancing the integrity and stability of the palatal model structure. It plays a role in guiding, supporting, and dispersing pressure during the injection of the impression material, which helps to obtain a stable, complete, and clear palatal impression. Its width and height are adapted to the space of the cleft palatal cavity, providing a flow guiding path for the impression and preventing collapse.

[0029] Optionally, the edge of the side support wing 2 is provided with an outward-curled edge structure, and the outer side of the rolled edge structure is covered with a cushioning pad.

[0030] Specifically, the edge of the side support wing 2 is provided with a rolled edge structure, and the rolled edge is covered with a silicone cushioning pad with a thickness of 1–2 mm to reduce pressure on the oral mucosa. The rolled edge design makes the edge transition smooth, which is used to improve the oral tolerance of the child and reduce the psychological burden on the family. The cushioning pad reduces pressure on the mucosa, which is used to reduce damage to the oral tissues of the child, improve the quality of the impression, enhance wearing comfort, and reduce the risk of tissue damage.

[0031] Optionally, the nasolabial groove adapter protrusion 3 has a wedge-shaped structure, with the end away from the palate protrusion 5 being higher than the end near the palate protrusion 5, and the side edge support wing 2 is guided and engaged with the end of the nasolabial groove adapter protrusion 3 away from the palate protrusion 5.

[0032] Specifically, the nasolabial groove adapter 3 can be raised and lowered to cover the nasal alar, nasal floor and columella, improve the integrity of nasal tissue impression and the accuracy of orthodontic appliance making, and achieve integrated molding of the nasolabial palate area.

[0033] In this embodiment, the lifting adjustment range of the nasolabial groove adapter boss 3 is 0-3mm.

[0034] Optionally, the upper side of the base plate 4 is provided with a lifting groove that cooperates with the nasolabial groove adapter boss 3. Part of the nasolabial groove adapter boss 3 is slidably disposed in the lifting groove. The nasolabial groove adapter boss 3 is connected to the bottom of the lifting groove through an adjusting screw. The adjusting screw is exposed from the lower side of the base plate 4 to form an operating end.

[0035] Specifically, the lower end of the nasolabial groove adapter boss 3 is inserted into the lifting groove. In this way, during the lifting and adjusting process of the nasolabial groove adapter boss 3, there will be no suspended space between the bottom of the nasolabial groove adapter boss 3 and the base plate 4, so as to avoid affecting the normal flow of the impression material. The operating end of the adjusting screw faces down and the threaded part faces up, passing through the base plate 4 and threadedly connected to the threaded hole of the nasolabial groove adapter boss 3. A limiting part can be set at the neck of the adjusting screw. The axial movement of the adjusting screw is restricted by the limiting part cooperating with the base plate 4. The nasolabial groove adapter boss 3 can be lifted and adjusted by turning the adjusting screw.

[0036] In other embodiments, the nasolabial groove adapter protrusion 3 can be configured as a modular structure and can still be 3D printed. Different heights of the nasolabial groove adapter protrusion 3 can be selected according to the patient's nasal wing structure. The nasolabial groove adapter protrusion 3 can be connected to the tray body through a slot-type connection structure.

[0037] Optionally, the pressure sensor 7 includes multiple piezoresistive films arranged in an array.

[0038] Specifically, multiple piezoresistive films are arranged in an array on the upper side of the tray to detect the force distribution during the impression process, help determine whether the impression is complete, and improve the safety and accuracy of clinical operation. The piezoresistive films are thin-film piezoresistive sensors. Multiple piezoresistive films can be connected to the signal acquisition module and wireless communication module embedded in the base plate 4, which can transmit the detection results to the terminal for observation and analysis.

[0039] In this embodiment, the pressure sensor 7 has a range of 0-50 kPa and an accuracy of ±0.5 kPa. It is a 0.5 mm × 0.5 mm flexible piezoresistive sensor, such as the PolyTac series.

[0040] Optionally, an expansion layer is provided on the upper side of the pressure sensor 7. The expansion layer is made of polycaprolactone and covers the upper surface of the tray body.

[0041] Specifically, the outer surface of the tray is further provided with a responsive polycaprolactone (PCL) expansion layer, which can expand slightly when the impression material is injected to improve the fit; this layer can expand slightly after contacting the impression material, thereby enhancing the fit of the tray surface to the tissue and improving the integrity of the impression.

[0042] Furthermore, the tray uses polylactic acid (PLA) as the base material, with nano-hydroxyapatite (nHA) and silver ion antibacterial agents added to the PLA base material. nHA enhances the mechanical strength and bioactivity of the material, reducing the risk of deformation during repeated use. The silver ion antibacterial agent provides long-lasting antibacterial function, supports a wider range of disinfection methods (such as high-temperature steam sterilization), and avoids cross-infection. This makes the tray biocompatible, sterilizable, and reusable, supporting high-temperature steam sterilization and allowing for multiple uses. The outer surface of the tray is further provided with a responsive polycaprolactone (PCL) expansion layer, with the pressure sensor 7 embedded under the expansion layer. For the palatal protrusions 5 of the arched layered honeycomb structure, the pressure sensor 7 can be distributed around the voids. The pressure sensor 7 is isolated and encapsulated by an ultra-thin medical film.

[0043] In summary, when using the impression collection tray for cleft lip and palate infants provided by this utility model, taking a single clinical impression collection operation as an example: First, under the premise that the child is emotionally stable, conscious, and all preparatory work for impression collection is completed, the pre-made and sterilized impression collection tray for cleft lip and palate infants is visually inspected to confirm that all structures of the tray are intact, without warping, and without foreign matter residue; then, the person taking the impression fills the tray with an appropriate amount of impression material, paying particular attention to ensuring that the material fully covers the palatal protrusion 5, the nasolabial groove matching protrusion 3, and the surface of the side edge support wings 2. Because the tray structure has been heightened according to the individual nasal shape for the nasolabial groove matching protrusion 3, there is no need to separately treat the nasal alar area. During placement, the impression material can automatically flow and fill the nasal base and columella area; then, the person taking the impression uses the handle 1 as a guide... For operators who are not used to using handle 1, handle 1 can be removed. Using the tray base plate 4 as the control point, the tray is gently inserted into the oral cavity along the maxillary direction. The tray body is initially positioned by the curvature of its contact with the palatal surface. Then, accurate positioning is achieved with the limiting support of the side support wings 2 and the rear positioning baffle 6. At this time, the tray forms a closed cavity with multi-point contact and structural stability, which is conducive to the formation of the impression material inside. Afterward, the tray is held in the mouth for tens of seconds to several minutes. After the impression material has initially solidified, it is slowly removed. Due to the rounded edge design and the addition of silicone cushioning pads, the risk of soft tissue traction and damage during the removal process can be effectively reduced. After the impression is completed, a three-dimensional model containing the complete tissue morphology of the nasal alar, nasal floor, columella, alveolar bone and palate can be obtained for the subsequent precision fabrication of the nasopalatine orthodontic appliance.

[0044] During the curing of the impression material, the flexible pressure sensor 7 integrated inside the tray can simultaneously record the pressure distribution between the oral tissue and various areas of the tray, paying particular attention to the contact force between the palatal protrusion 5 and the nasolabial groove fitting protrusion 3. The collected data is transmitted to an external mobile terminal or data processing platform via a wireless communication module, displaying the impression force in real time and facilitating the analysis of fit uniformity. This helps assess the quality of the impression and provides feedback for subsequent tray design. After the impression is taken, the tray can be sterilized by low-temperature plasma, high-temperature high-pressure, or immersion in a neutral disinfectant, exhibiting good reusability.

[0045] This embodiment provides a tray that closely fits the maxillofacial structure of infants with cleft lip and palate, features a unique nasal design, palatal drainage support, is easy to operate, safe, and reusable. It can significantly improve the integrity and efficiency of impression taking and optimize the precision of orthodontic appliance manufacturing, and has important clinical application value and promotion prospects.

[0046] The present invention provides a tray for taking impressions of infants with cleft lip and palate, which can be manufactured using the following method: Multiple three-dimensional craniofacial data were collected from several infants with cleft lip and palate. Multiple craniofacial models were constructed based on the collected data; An average morphological model was obtained based on multiple craniofacial models; The above-mentioned tray for taking impressions of infants with cleft lip and palate was modeled based on the average morphological model. Based on the modeling results, the above-mentioned tray for taking impressions of infants with cleft lip and palate was made.

[0047] Specifically, to ensure the accuracy and universality of the aforementioned tray for taking impressions of infants with cleft lip and palate, this method first involves acquiring multimodal three-dimensional craniofacial data from multiple infants with cleft lip and palate. This acquisition can be achieved through various imaging techniques, including facial 3D scanning, intraoral scanning, and cone-beam computed tomography (CBCT). Each modality provides information on the morphology of the nasal soft tissue, the surface structure of the oral mucosa, and the morphology of the bony cleft. After fusion, a complete and high-precision craniofacial model can be constructed. Then, data registration and fusion are performed, spatially aligning and geometrically fusing craniofacial information from different data sources to construct a high-precision three-dimensional fused model under a unified coordinate system. This results in the construction of multiple craniofacial models, realistically reproducing the maxillary cleft. The complex structural morphology of the cleft lip and palate region is analyzed. Then, artificial intelligence analysis algorithms are used to extract and model structural features from multiple craniofacial models, generating a statistically representative average morphological model of the cleft lip and palate jawbone, providing a fitting basis for subsequent tray design. At this point, the aforementioned tray for taking impressions of infants with cleft lip and palate can be modeled based on the average morphological model, including the anatomical fit design of the tray body, the irregular elevation treatment of the nasolabial fold in the cleft region, and the setting of the guiding structure for the palatal protrusion 5, ensuring a high-precision fit between the tray and the nasolabial-alveolar region. Finally, the aforementioned tray for taking impressions of infants with cleft lip and palate is manufactured based on the modeling results. The completed 3D structure of the tray can be exported as a standard format file, and a physical tray can be formed using 3D printing technology.

[0048] Optionally, it also includes: Clinical validation information was obtained for the trays used to take impressions of infants with cleft lip and palate in clinical practice. The structure of the impression tray for infants with cleft lip and palate was optimized based on clinical validation information.

[0049] Specifically, to further optimize the manufactured physical tray and precisely adjust the height of the nasolabial groove fitting protrusion 3, the manufactured physical tray can be clinically validated. Its performance indicators such as impression integrity, tissue coverage, and wearing stability can be examined. Based on data feedback during use, the tray structural parameters can be optimized and adjusted to improve the adaptability of the tray structure.

[0050] In this embodiment, the clinical verification information includes pressure feedback data from the pressure sensor 7 on the upper side of the palatal protrusion 5 and the upper side of the nasolabial groove adapter protrusion 3, respectively.

[0051] In this embodiment, optimizing the structure of the impression tray for infants with cleft lip and palate based on clinical verification information includes: adjusting the size of multiple recessed guide sections based on pressure feedback data from pressure sensor 7 on the upper side of palatal protrusion 5; and adjusting the height of nasolabial groove adapter protrusion 3 based on pressure feedback data on the upper side of nasolabial groove adapter protrusion 3.

[0052] The various embodiments of the present invention have been described above. These descriptions are exemplary and not exhaustive, nor are they limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments.

Claims

1. A tray for taking impressions of infants with cleft lip and palate, characterized in that, include: The tray body includes a base plate, a raised palatal protrusion is provided at the center of one end of the base plate, a rear edge positioning baffle is provided on both sides of the palatal protrusion at one end of the base plate, a side edge support wing is provided on the outer periphery of the base plate and connected to the two rear edge positioning baffles, and a liftable nasolabial groove adapter protrusion is provided at the center of the other end of the base plate. A pressure sensor is disposed on the upper side of the base plate, the palatal protrusion, and the nasolabial groove adapter protrusion.

2. The tray for taking impressions of infants with cleft lip and palate according to claim 1, characterized in that, A handle is detachably connected to the other side of the base plate.

3. The tray for taking impressions of infants with cleft lip and palate according to claim 1, characterized in that, The palatal protrusion has an arched structure, and the surface of the palatal protrusion is provided with multiple recessed guide portions.

4. The tray for taking impressions of infants with cleft lip and palate according to claim 1, characterized in that, The edge of the side support wing is provided with an outward-curled edge structure, and the outer side of the rolled edge structure is covered with a cushioning pad.

5. The tray for taking impressions of infants with cleft lip and palate according to claim 1, characterized in that, The nasolabial groove adapter protrusion has a wedge-shaped structure, with the end away from the palate protrusion being higher than the end close to the palate protrusion. The side edge support wing is guided and engaged with the end of the nasolabial groove adapter protrusion away from the palate protrusion.

6. The tray for taking impressions of infants with cleft lip and palate according to claim 1, characterized in that, The upper side of the base plate is provided with a lifting groove that mates with the nasolabial groove adapter boss. Part of the nasolabial groove adapter boss is slidably disposed in the lifting groove. The nasolabial groove adapter boss is connected to the bottom of the lifting groove through an adjusting screw. The adjusting screw is exposed from the lower side of the base plate to form an operating end.

7. The tray for taking impressions of infants with cleft lip and palate according to claim 1, characterized in that, The pressure sensor includes multiple piezoresistive films, which are arranged in an array.

8. The tray for taking impressions of infants with cleft lip and palate according to claim 1, characterized in that, An expansion layer is provided on the upper side of the pressure sensor. The expansion layer is made of polycaprolactone and covers the upper surface of the tray body. An antibacterial coating is provided on the upper side of the expansion layer.

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