Patent No. US10946630 (titled "Dual Shell Dental Appliance And Material Constructions") was filed by Bay Materials Llc on Dec 12, 2019.
’630 is related to the field of polymeric sheets, specifically those used in dental appliances like aligners, mouth guards, and splints. These appliances require a balance of flexibility, strength, stain resistance, and the ability to apply controlled forces to teeth. Existing single-layer, bi-layer, or tri-layer materials often suffer from performance deficiencies such as limited elasticity, creep, stress relaxation, staining, and environmental stress cracking.
The underlying idea behind ’630 is to create a multi-layer polymeric sheet with outer layers of a relatively hard thermoplastic and an inner core of a softer elastomer. This combination aims to provide the necessary rigidity for force application while also offering flexibility, improved stain resistance, and resistance to stress cracking. The key insight is that by distributing the mechanical properties across multiple layers, the shortcomings of single-material solutions can be overcome.
The claims of ’630 focus on a polymeric sheet composition comprising at least two outer layers (A and C) and an elastomeric inner layer (B). The outer layers are made of a polyester or co-polyester with a flexural modulus between 1,000 MPa and 2,500 MPa. The inner layer is an elastomeric material with a hardness between A80 and D75 on the Shore scale. The overall sheet composition has a flexural modulus between 750 MPa and 2,000 MPa. Another claim focuses on a sheet with more than two rigid layers, where at least one rigid layer is between two or more elastomeric layers, with specified modulus and hardness ranges.
In practice, the invention involves selecting appropriate materials for the outer and inner layers based on their modulus, hardness, and other properties like glass transition temperature and melting point. The layers are then combined using techniques like lamination or co-extrusion to form a sheet. This sheet can then be thermoformed into a dental appliance. The elastomeric inner layer allows the appliance to deform reversibly and apply controlled forces to the teeth, while the outer layers provide the necessary stiffness and stain resistance.
The invention differentiates itself from prior approaches by using a specific combination of hard outer layers and a softer elastomeric core. Unlike single-material appliances, this multi-layer design provides a balance of properties that are difficult to achieve with a single material. Furthermore, the invention emphasizes the importance of interlayer adhesion to prevent stress cracking and ensure durability. By carefully selecting materials and manufacturing processes, the invention aims to create dental appliances that are more comfortable, effective, and durable than existing solutions.
In the late 2010s when ’630 was filed, multi-layer polymeric sheets were commonly used in various applications, including dental appliances, at a time when achieving a balance between flexibility, strength, and stain resistance in these materials was non-trivial. When designing such sheets, engineers typically considered the modulus, glass transition temperature, and melting point of the constituent polymers to optimize performance. At that time, the ability to create dental appliances that could accurately move teeth while resisting creep, stress relaxation, and staining presented significant engineering challenges.
The examiner approved the application because the prior art of record does not teach or suggest a polymeric sheet composition that includes an elastomeric inner layer with a hardness between A80 and D75, combined with a polymeric sheet composition having a flexural modulus between 750 MPa and 2,000 MPa. Furthermore, the prior art does not teach any motivation or suggestion to modify existing materials to achieve the claimed invention.
This patent includes 18 claims, with claims 1 and 15 being independent. The independent claims are directed to polymeric sheet compositions comprising multiple layers with specific material properties and arrangements. The dependent claims generally elaborate on the composition and characteristics of the polymeric sheet, and also describe dental appliances made from the sheet.
Definitions of key terms used in the patent claims.
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