Multilayer Polymer Sheets

Patent No. US11648091 (titled "Multilayer Polymer Sheets") was filed by Align Technology Inc on Sep 2, 2022.

What is this patent about?

’091 is related to the field of orthodontics, specifically the design and materials used in removable dental aligners. Traditional aligners, like braces, apply force to teeth to gradually shift them. Newer aligner systems use a series of preformed appliances designed using computer modeling to incrementally reposition teeth. There is a need for aligner materials with improved durability and elastic properties to reduce the number of aligners needed and avoid mid-course corrections.

The underlying idea behind ’091 is to create a multilayer aligner with improved mechanical properties by combining a hard polymer layer between two soft polymer layers. This configuration aims to enhance the aligner's ability to maintain consistent force over time, resist deformation, and withstand wear and tear from insertion, removal, and teeth grinding. The combination of materials is designed to provide both the necessary stiffness for tooth movement and the flexibility for patient comfort and appliance durability.

The claims of ’091 focus on a multilayer sheet incorporated into an orthodontic appliance, where the sheet comprises a first layer of a single co-polyester polymer with specific mechanical properties (high flexural modulus, tensile strength, and elongation), a second layer of a single thermoplastic polyurethane elastomer polymer with its own set of properties (high tensile strength, elongation, and hardness), and a third layer. The key is the specific combination of these materials to achieve a balance of strength and flexibility.

The aligner is fabricated by thermoforming this multilayer sheet over a model of the patient's teeth in a target position. The co-polyester layer provides the necessary stiffness to apply force to the teeth, while the thermoplastic polyurethane elastomer layers offer flexibility and comfort for the patient. This construction allows the aligner to maintain its shape and force over a longer period, reducing the need for frequent aligner changes or mid-course corrections.

Prior aligners often suffered from stress relaxation and deformation, leading to reduced effectiveness over time. The ’091 invention addresses this by using a specific combination of materials that exhibit improved stress relaxation properties and long-term unloading characteristics. Tests show that aligners made with this multilayer sheet maintain their shape and apply force more consistently compared to existing materials, ultimately leading to more efficient and predictable tooth movement.

How does this patent fit in bigger picture?

Technical landscape at the time

In the early 2010s when ’091 was filed, orthodontic aligner systems were gaining traction at a time when treatment planning was typically implemented using computer-based 3D modeling. At that time, aligners commonly relied on single-layer polymer construction rather than multi-layer, and hardware or software constraints made it non-trivial to optimize material properties for continuous force application and durability.

Novelty and Inventive Step

The examiner approved the application because the prior art failed to disclose a multilayer sheet utilized in an orthodontic appliance where the multilayer sheet comprises a first layer containing a single copolyester polymer, a second layer containing a single thermoplastic polyurethane elastomer, and a third layer, where the first and second layers have a difference in elastic modulus. The examiner also stated that prior art failed to disclose a dental aligner containing such a multilayer sheet.

Claims

This patent contains 26 claims, with independent claims numbered 1, 6, 10, and 18. The independent claims are directed to a multilayer sheet and multilayer dental aligners comprising the sheet, where the sheet includes a co-polyester layer and a thermoplastic polyurethane elastomer layer. The dependent claims generally elaborate on the composition and configuration of the multilayer sheet and dental aligner.

Key Claim Terms New

Definitions of key terms used in the patent claims.

Term (Source)Support for SpecificationInterpretation
Co-polyester
(Claim 1, Claim 6, Claim 10, Claim 18)
“In one embodiment, the present invention provides a dental appliance for positioning a patient's teeth. The dental appliance can include a removable orthodontic tooth positioning appliance having teeth receiving cavities shaped to directly receive at least some of the patient's teeth and apply a resilient positioning force to the patient's teeth, the appliance comprising a hard polymer layer disposed between a first soft polymer layer and a second soft polymer layer.”A single polymer used in the first layer of the multilayer sheet, characterized by specific mechanical properties including flexural modulus, elongation at yield, tensile modulus, tensile strength at yield, and elongation at break.
Multilayer Sheet
(Claim 1, Claim 6, Claim 10, Claim 18)
“The presently disclosed appliances, methods, and systems provide means by which such forces can be applied during orthodontic treatment where appliances having teeth receiving cavities are used, such as preformed appliances/aligners available from Align Technology, Inc., San Jose, Calif., under the trade name Invisalign® System. As provided by the present invention, the aligners that include multilayer sheets can, for example, provide increased durability of the aligners so that they can better withstand wear due to aligner reinsertion and removal and other mechanical stresses put on the aligner during treatment.”A sheet composed of multiple layers of different materials, specifically a first layer, a second layer, and a third layer, where the first and second layers are defined by their polymer composition and mechanical properties.
Thermoplastic Polyurethane Elastomer
(Claim 1, Claim 6, Claim 10, Claim 18)
“In one embodiment, the present invention provides a dental appliance for positioning a patient's teeth. The dental appliance can include a removable orthodontic tooth positioning appliance having teeth receiving cavities shaped to directly receive at least some of the patient's teeth and apply a resilient positioning force to the patient's teeth, the appliance comprising a hard polymer layer disposed between a first soft polymer layer and a second soft polymer layer.”A single polymer used in the second layer of the multilayer sheet, characterized by specific mechanical properties including ultimate tensile strength, elongation at break, and hardness.
Tooth-receiving Cavities
(Claim 6, Claim 10, Claim 18)
“The dental appliance can include a removable orthodontic tooth positioning appliance having teeth receiving cavities shaped to directly receive at least some of the patient's teeth and apply a resilient positioning force to the patient's teeth, the appliance comprising a hard polymer layer disposed between a first soft polymer layer and a second soft polymer layer.”Cavities formed by the multilayer sheet that are shaped to directly receive at least some of the patient's teeth and apply a resilient positioning force to the patient's teeth.

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US11648091

ALIGN TECHNOLOGY INC
Application Number
US17902445
Filing Date
Sep 2, 2022
Status
Granted
Expiry Date
May 14, 2032
External Links
Slate, USPTO, Google Patents