Patent No. US10870263 (titled "Dual shell dental appliance and material constructions") on Dec 18, 2019. The application was issued on Dec 22, 2020.
’263 is related to the field of dental appliances and polymeric sheet compositions used for orthodontic treatments. Specifically, it addresses the material science challenges of creating dental aligners, retainers, and mouth guards that must balance the conflicting requirements of high structural rigidity for precise tooth movement and high elasticity for patient comfort and durability. The background context involves the limitations of traditional single-layer or simple multi-layer plastics, which often suffer from rapid force decay, stress cracking, and susceptibility to staining from food and beverages.
The underlying idea behind ’263 is a “dual shell” architecture that sandwiches a soft, elastomeric core between two or more relatively rigid outer layers. By utilizing a high-modulus outer material for tooth contact and a low-modulus elastomer for the internal volume, the invention allows the rigid shells to move independently and reversibly relative to one another. This mechanical decoupling enables the appliance to exert a sustained orthodontic force over a wider range of movement than a solid plastic part, effectively reducing the frequency of appliance changes while mitigating the initial “pressure spikes” that cause patient discomfort.
The claims of ’263 focus on a multi-layer polymeric sheet where the outer layers possess a flexural modulus between 1,000 MPa and 2,500 MPa, while the internal elastomeric layer has a hardness ranging from Shore A 60 to D 85. The independent claims specifically protect various configurations of this stack, including three-layer ABC structures, five-layer stacks with additional rigid internal cores, and asymmetric designs where the outermost layers have different thicknesses. Furthermore, the claims specify that the total composite thickness remains between 250 and 2,000 microns, maintaining a total flexural modulus of 500 MPa to 1,500 MPa.
In practice, the invention works by leveraging the interlayer peel strength—which must exceed 50 N per 2.5 cm—to ensure that the rigid and soft layers act as a cohesive unit without delaminating. This high bond strength is critical because it allows the elastomeric core to absorb and redistribute the mechanical stresses that typically cause amorphous polyesters to crack. When the appliance is deformed over a patient's teeth, the elastomer acts as a stress-relief reservoir, allowing the rigid outer shells to maintain their precise geometry and stain resistance while providing a gentle, spring-like restoring force.
This approach differs from prior solutions that placed soft elastomers on the outside of the appliance, which often resulted in poor tooth-tracking accuracy and significant staining. By moving the elastomer to the center and utilizing specific materials like anhydride-functionalized styrenic elastomers or aromatic polyether polyurethanes with low compression sets, the invention achieves superior environmental stress cracking resistance. The result is a dental appliance that is more durable in the presence of saliva and mouthwash while providing more predictable and comfortable tooth movement than traditional monolayer aligners.
In the late 2010s when ’263 was filed, dental appliances such as orthodontic aligners and mouth guards were typically implemented using single-layer, bi-layer, or tri-layer polymeric sheets. At a time when these systems commonly relied on monolithic rigid plastics or simple laminates to apply force to teeth, engineering constraints made it non-trivial to balance the high modulus required for precise tooth movement with the elasticity needed to prevent rapid stress relaxation and patient discomfort. Furthermore, when hardware and material constraints forced a trade-off between mechanical durability and aesthetic requirements, such as stain resistance and transparency, practitioners often had to choose between materials that were effective at moving teeth but prone to environmental stress cracking or those that were comfortable but lacked the structural integrity to maintain accurate translational forces.
The disclosed invention represents a meaningful technical advancement through an architectural shift in multi-layer polymeric sheet construction, specifically integrating high-modulus outer layers with a lower-modulus elastomeric core. This structural solution addresses the technical problem of limited elastic range and rapid force decay inherent in traditional rigid aligner materials. By utilizing outer layers with a modulus between 1,000 MPa and 2,500 MPa and an inner elastomeric layer between 50 MPa and 500 MPa, the invention enables a capability for the outer shells to be reversibly displaced relative to one another. This configuration achieves the technical effect of maintaining a nearly constant lateral restoring force over a greater range of movement while simultaneously overcoming the constraint of environmental stress cracking. The resulting integration provides a dental appliance that combines the precise force application of rigid materials with the durability and stain resistance required for long-term clinical use.
This patent contains 34 claims, with claims 1, 11, 19, 30, 31, 32, 33, and 34 serving as the independent claims. The independent claims focus on a multi-layered polymeric sheet composition featuring at least one elastomeric inner layer and two or more outer layers, characterized by specific flexural modulus ranges for the rigid layers and hardness values for the elastomeric components, with some claims further specifying chemical compositions like co-polyesters or polyurethanes and physical properties such as peel strength and compression set. The dependent claims serve to further define the material selections, layer thicknesses, thermal properties, and specific applications of the composition, such as its use in dental appliances.
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