# US 11,999,141 B2 · Dual shell dental appliance and material constructions

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- Number: US 11,999,141 B2
- Document ID: US11999141B2
- Status: Granted
- Kind: B2
- Application number: 18/061,056
- Filed: 2022-12-02
- Published: 2023-04-06
- Granted: 2024-06-04
- Earliest claimed: 2017-05-31
- Assignees: Bay Materials, LLC
- Applicants: Bay Materials, LLC
- Inventors: Ray F. Stewart; John Lahlouh
- Web page: https://patentgrep.com/patent/US11999141B2

## CPC

- B32B 27/08: of synthetic resin
- A61C 7/08: Mouthpiece-type retainers {or positioners, e.g. for both the lower and upper arch (arch-shaped medicament applicators for teeth or gums A61C19/063; mouthguards for protecting the teeth of sportsmen A63B71/085)}
- B32B 27/302: {comprising aromatic vinyl (co)polymers, e.g. styrenic (co)polymers}
- B32B 27/32: comprising polyolefins {(comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30)}
- B32B 27/34: comprising polyamides
- B32B 27/36: comprising polyesters
- B32B 27/40: comprising polyurethanes
- B32B 2250/24: All layers being polymeric
- B32B 2274/00: Thermoplastic elastomer material
- B32B 2307/536: Hardness
- B32B 2307/54: Yield strength; Tensile strength
- B32B 2307/546: Flexural strength; Flexion stiffness
- B32B 2307/7376: Thickness
- B32B 2535/00: Medical equipment, e.g. bandage, prostheses or catheter
- B32B: LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- A61C: DENTISTRY; APPARATUS OR METHODS FOR ORAL OR DENTAL HYGIENE (non-driven toothbrushes A46B; {tongue scrapers A61B17/24;} preparations for dentistry A61K6/00; preparations for cleaning the teeth or mouth A61K8/00, A61Q11/00)

## Abstract

Improved dental appliances and polymeric sheet compositions are disclosed. The polymeric sheet compositions are useful for making dental appliances having outer layers comprised of a material having a modulus of from about 1,000 MPA to 2,500 MPA (“hard”) and an inner core comprised of elastomeric material or materials having a modulus of from about 50 MPa to 500 MPa (“soft”), which exhibit improved flexibility and strength, and better stain and tear resistance than currently available materials and dental appliances.

## Claims

### Claim 1

A polymeric sheet composition, comprising:
a thermoplastic polymer layer having a flexural modulus of from about 1,000 MPa to 2,500 Mpa; and
an elastomeric layer comprising an elastomeric material having a hardness of from about A 80 to D 75.

### Claim 2 (depends on 1)

The polymeric sheet composition of claim 1, wherein the elastomeric layer comprises an elastomeric material having a hardness of from about A 80 to D 65.

### Claim 3 (depends on 1)

The polymeric sheet composition of claim 1, wherein the elastomeric layer comprises a material having a melting point of from about 90° C. to about 220° C.

### Claim 4 (depends on 1)

The polymeric sheet composition of claim 1, wherein the polymeric sheet composition has a combined thickness of from 250 microns to 2,000 microns.

### Claim 5 (depends on 1)

A reversibly deformable dental appliance conformal to one or more teeth comprising the polymeric sheet composition according to claim 1.

### Claim 6 (depends on 1)

The polymeric sheet composition of claim 1, wherein the thermoplastic polymer layer has a glass transition temperature of from about 100° C. to about 120° C.

### Claim 7 (depends on 1)

The polymeric sheet composition of claim 1, wherein the thermoplastic polymer layer has a glass transition temperature of from about 80° C. to about 180° C.

### Claim 8 (depends on 1)

The polymeric sheet composition of claim 1, wherein the thermoplastic polymer layer has a hardness of from about R100 to about R115.

### Claim 9 (depends on 1)

The polymeric sheet composition of claim 1, wherein the thermoplastic polymer layer comprises a polyester or copolyester.

### Claim 10 (depends on 1)

The polymeric sheet composition of claim 1, wherein the elastomeric layer comprises a polyester or copolyester.

### Claim 11 (depends on 1)

The polymeric sheet composition of claim 1, further comprising a second thermoplastic polymer layer having a flexural modulus of from about 1,000 MPa to 2,500 Mpa, wherein the elastomeric layer is positioned between the thermoplastic polymer layer and the second thermoplastic polymer layer.

### Claim 12 (depends on 11)

The polymeric sheet composition of claim 11, further comprising:
a second elastomeric layer comprising an elastomeric material having a hardness of from about A 60 to D 85; and
a third thermoplastic polymer layer having a flexural modulus of from about 1,000 MPa to 2,500 Mpa.

### Claim 13 (depends on 12)

The polymeric sheet composition of claim 12, wherein the polymeric sheet composition has a combined thickness of from 250 microns to 2,000 microns.

### Claim 14 (depends on 12)

The polymeric sheet composition of claim 12, wherein the thermoplastic polymer layer, the second thermoplastic polymer layer, and the third thermoplastic polymer layer have a combined thickness of from about 100 microns to about 750 microns.

### Claim 15 (depends on 12)

The polymeric sheet composition of claim 12, wherein the elastomeric layer and the second elastomeric layer have a combined thickness of from about 150 microns to about 1,000 microns.

### Claim 16 (depends on 11)

A dental appliance conformal to one or more teeth comprising a polymeric sheet composition according to claim 11.

### Claim 17 (depends on 11)

A dental aligner conformal to one or more teeth comprising a polymeric sheet composition according to claim 11.

### Claim 18 (depends on 1)

The polymeric sheet composition of claim 1, wherein the elastomeric layer comprises a material having a melting point of from about 90° C. to about 220° C., and wherein the thermoplastic polymer layer has a glass transition temperature of from about 80° C. to about 180° C.

### Claim 19 (depends on 1)

The polymeric sheet composition of claim 1, wherein the elastomeric layer comprises a polyester, a polyurethane or a polyether-polyamide.

### Claim 20 (depends on 12)

The polymeric sheet composition of claim 12, wherein the second elastomeric layer comprising an elastomeric material having a hardness of from about A 80 to D 75.