Multilayer dental appliances and related methods and systems

• US 10,052,176 B2
• Filed: 03/31/2017
• Issued: 08/21/2018
• Est. Priority Date: 05/14/2012
• Status: Active Grant

• Current Assignee: Align Technology Incorporated
• Original Assignee: Align Technology Incorporated
• Inventors: Li, Chunhua, Chen, Yan, Pudleiner, Heinz, Meyer, Klaus, Nickel, Joerg, Pehlert, Craig
• Primary Examiner(s): Rodriguez, Cris L
• Assistant Examiner(s): Mai, Hao D
• Application Number:
  US15/476,622
• Publication Number:
  US 20170202640A1
• Time in Patent Office: 508 Days
• CPC Class Codes: A61C 13/00 Dental prostheses; Making same tooth crowns for capping teeth A61C5/70; dental implants A61C8/00
• CPC Class Codes: A61C 19/06 Implements for therapeutic treatment radiation therapy A61N5/00
• CPC Class Codes: A61C 7/00 Orthodontics, i.e. obtaining or maintaining the desired position of teeth, e.g. by straightening, evening, regulating, separating, or by correcting malocclusions
• CPC Class Codes: 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
• CPC Class Codes: A61F 5/56 Devices for preventing snoring by influencing the respiratory system by gas treatment A61M16/00
• CPC Class Codes: A63B 71/085 Mouth or teeth protectors A63B71/081 takes precedence
• CPC Class Codes: B29C 51/14 using multilayered preforms or sheets
• CPC Class Codes: B29K 2067/00 Use of polyesters or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2075/00 Use of PU, i.e. polyureas or polyurethanes or derivatives thereof, as moulding material
• CPC Class Codes: B29K 2995/0026 Transparent
• CPC Class Codes: B29K 2995/007 Hardness
• CPC Class Codes: B29K 2995/0077 Yield strength; Tensile strength
• CPC Class Codes: B29K 2995/0082 Flexural strength; Flexion stiffness
• CPC Class Codes: B29L 2031/753 Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: B32B 2250/03 3 layers
• CPC Class Codes: B32B 2250/24 All layers being polymeric
• CPC Class Codes: B32B 2250/40 Symmetrical or sandwich layers, e.g. ABA, ABCBA, ABCCBA
• CPC Class Codes: B32B 2274/00 Thermoplastic elastomer material thermoplastic elastomer fibres B32B2262/0215, thermoplastic elastomer particles B32B2264/0221, thermoplastic elastomer foam B32B2266/0292
• CPC Class Codes: B32B 2307/40 having particular optical properties light or UV resistant B32B2307/71
• CPC Class Codes: B32B 2307/412 Transparent
• CPC Class Codes: B32B 2307/50 : having particular mechanical properties
• CPC Class Codes: B32B 2307/51 : Elastic
• CPC Class Codes: B32B 2307/536 : Hardness
• CPC Class Codes: B32B 2307/54 : Yield strength; Tensile strength
• CPC Class Codes: B32B 2307/546 : Flexural strength; Flexion stiffness
• CPC Class Codes: B32B 2319/00 : Synthetic rubber natural rubber B32B2317/22
• CPC Class Codes: B32B 2323/00 : Polyalkenes
• CPC Class Codes: B32B 2323/04 : Polyethylene
• CPC Class Codes: B32B 2323/10 : Polypropylene
• CPC Class Codes: B32B 2323/16 : EPDM, i.e. ethylene propylene diene monomer
• CPC Class Codes: B32B 2333/04 : Polymers of esters
• CPC Class Codes: B32B 2367/00 : Polyesters, e.g. PET, i.e. polyethylene terephthalate
• CPC Class Codes: B32B 2371/00 : Polyethers, e.g. PEEK, i.e. polyether-etherketone; PEK, i.e. polyetherketone
• CPC Class Codes: B32B 2375/00 : Polyureas; Polyurethanes
• CPC Class Codes: B32B 2377/00 : Polyamides
• CPC Class Codes: B32B 2383/00 : Polysiloxanes
• CPC Class Codes: B32B 25/08 : of synthetic resin
• CPC Class Codes: B32B 25/14 : comprising synthetic rubber copolymers B32B25/18 and B32B25/20 take precedence
• CPC Class Codes: B32B 25/20 : comprising silicone rubber
• CPC Class Codes: B32B 2535/00 : Medical equipment, e.g. bandage, prostheses, catheter medical patches B32B2556/00
• CPC Class Codes: B32B 2555/00 : Personal care
• CPC Class Codes: B32B 27/08 : of synthetic resin
• CPC Class Codes: B32B 27/281 : comprising polyimides
• CPC Class Codes: B32B 27/283 : comprising polysiloxanes
• CPC Class Codes: B32B 27/285 : comprising polyethers
• CPC Class Codes: B32B 27/286 : comprising polysulphones; polysulfides
• CPC Class Codes: B32B 27/30 : comprising vinyl (co)polymers; comprising acrylic (co)polymers
• CPC Class Codes: B32B 27/302 : comprising aromatic vinyl (co)polymers, e.g. styrenic (co)polymers
• CPC Class Codes: B32B 27/308 : comprising acrylic (co)polymers
• CPC Class Codes: B32B 27/32 : comprising polyolefins comprising vinyl (co)polymers or acrylic (co)polymers B32B27/30
• CPC Class Codes: B32B 27/34 : comprising polyamides
• CPC Class Codes: B32B 27/36 : comprising polyesters
• CPC Class Codes: B32B 27/365 : comprising polycarbonates
• CPC Class Codes: B32B 27/40 : comprising polyurethanes
• CPC Class Codes: B32B 7/022 : Mechanical properties
• CPC Class Codes: Y10T 428/31551 : Of polyamidoester [polyurethane, polyisocyanate, polycarbamate, etc.]
• CPC Class Codes: Y10T 428/31565 : Next to polyester [polyethylene terephthalate, etc.]
• CPC Class Codes: Y10T 428/31786 : Of polyester [e.g., alkyd, etc.]

Abstract

A dental appliance for positioning a patient'"'"'s teeth includes 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 includes a hard polymer layer having a hard polymer layer elastic modulus disposed between a first soft polymer layer having a first soft polymer layer elastic modulus and a second soft polymer layer having a second soft polymer layer elastic modulus. The hard polymer layer elastic modulus is greater than each of the first soft polymer layer elastic modulus and the second soft polymer layer elastic modulus. At least one of the first soft polymer layer and the second soft polymer layer has a flexural modulus of greater than about 35,000 psi.

Claims

1. A removable orthodontic tooth positioning appliance having teeth receiving cavities shaped to directly receive at least some of a patient'"'"'s teeth and apply a resilient positioning force to the patient'"'"'s teeth, the appliance comprising:

a first soft outer polymer layer comprising a first soft polymeric material and a second soft outer polymer layer comprising a second soft polymeric material, each of the first and second soft polymer layers having a flexural modulus of greater than about 35,000 psi, a hardness of about 60 A to about 85 D, and a thickness in a range from 25 μ

m to 100 μ

m; and

a hard inner polymer layer comprising a co-polyester disposed between the first soft outer polymer layer and the second soft outer polymer layer so as to reduce degradation of the resilient positioning force applied to the teeth when the appliance is worn.

2. The appliance of claim 1, wherein:

the first soft polymeric material comprises a material selected from;

a thermoplastic polyurethane elastomer, a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a block copolymer elastomer, a polyolefin blend elastomer, a thermoplastic co-polyester elastomer, a thermoplastic polyamide elastomer, or a combination thereof; and

the second soft polymeric material comprises a material selected from;

a thermoplastic polyurethane elastomer, a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a block copolymer elastomer, a polyolefin blend elastomer, a thermoplastic co-polyester elastomer, a thermoplastic polyamide elastomer, or a combination thereof.

3. The appliance of claim 2, wherein the first soft polymeric material and the second soft polymeric material are the same.

4. The appliance of claim 2, wherein the first soft polymeric material and the second soft polymeric material are different.

5. The appliance of claim 2, wherein the first and second soft polymeric materials each comprises a blend of polymeric materials, each respective blend including two or more materials selected from the group consisting of:

a thermoplastic polyurethane elastomer, a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a block copolymer elastomer, a polyolefin blend elastomer, a thermoplastic co-polyester elastomer, and a thermoplastic polyamide elastomer.

6. The appliance of claim 2, wherein at least one of the first soft outer polymer layer and the second soft outer polymer layer comprises at least two layers.

7. The appliance of claim 1, wherein the hard inner polymer layer comprises a blend of polymeric materials including the co-polyester and one or more of:

a polyester, a thermoplastic polyurethane, a polypropylene, a polyethylene, a polypropylene and polyethylene copolymer, an acrylic, a polyetheretherketone, a polyamide, a polyethylene terephthalate, a polybutylene terephthalate, a polyetherimide, a cyclic block copolymer, a polyethersulfone, a polytrimethylene terephthalate, or a combination thereof.

8. The appliance of claim 1, wherein the hard inner polymer layer comprises at least two layers including a first layer comprising the co-polyester and a second layer comprising one or more of:

a polyester, a co-polyester, a thermoplastic polyurethane, a polypropylene, a polyethylene, an acrylic, a polyetheretherketone, a polyamide, a polyethylene terephthalate, a polybutylene terephthalate, a polyetherimide, a cyclic block copolymer, a polyethersulfone, or a polytrimethylene terephthalate.

9. The appliance of claim 1, wherein the hard inner polymer layer has a thickness in a range from 400 μ

m to 1100 μ

m.

10. The appliance of claim 1, wherein the hard inner polymer layer, the first soft outer polymer layer, and the second soft outer polymer layer combined have a thickness of 500 μ

m to 1200 μ

m.

11. The appliance of claim 1, wherein the hard inner polymer layer comprises at least one of:

a tensile strength at yield of between about 4000 pounds per square inch (psi) and 6500 psi, an elongation at yield of greater than about 4%, an elongation at break of greater than about 70%, a tensile modulus of greater than about 150,000 psi, a flexural modulus greater than about 150,000 psi, a stress relaxation of greater than about 10% at 24 hours testing in a high humidity environment, or a light transmission between 400 nm and 800 nm of greater than about 75%.

12. The appliance of claim 1, wherein the first soft outer polymer layer and the second soft outer polymer layer each independently comprises at least one of:

an ultimate tensile strength of greater than about 5000 psi, an elongation at break of greater than about 200%, a compression set at about 70°

C. of greater than 40% after 24 hours, or a light transmission between 400 nm and 800 nm of greater than about 75%.

13. A plurality of incremental position adjustment appliances having teeth receiving cavities shaped to directly receive at least some of a patient'"'"'s teeth and apply a resilient positioning force to the patient'"'"'s teeth, wherein the appliances are shaped to move teeth from one arrangement to a successive arrangement when successively worn by the patient, and wherein at least one of the appliances comprises:

a first soft outer polymer layer comprising a first soft polymeric material and a second soft outer polymer layer comprising a second soft polymeric material, each of the first and second soft polymer layers having a flexural modulus of greater than about 35,000 psi, a hardness of about 60 A to about 85 D, and a thickness in a range from 25 μ

m to 100 μ

m; and

a hard inner polymer layer comprising a co-polyester disposed between the first soft outer polymer layer and the second soft outer polymer layer so as to reduce degradation of the resilient positioning force applied to the teeth when the appliance is worn.

14. The plurality of appliances of claim 13, wherein

the first soft polymeric material comprises a material selected from:

a thermoplastic polyurethane elastomer, a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a block copolymer elastomer, a polyolefin blend elastomer, a thermoplastic co-polyester elastomer, a thermoplastic polyamide elastomer, or a combination thereof; and

the second soft polymeric material comprises a material selected from;

a thermoplastic polyurethane elastomer, a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a block copolymer elastomer, a polyolefin blend elastomer, a thermoplastic co-polyester elastomer, a thermoplastic polyamide elastomer, or a combination thereof.

15. A method of moving a patient'"'"'s teeth from an initial configuration to a target configuration, the method comprising providing a removable orthodontic tooth positioning appliance having teeth receiving cavities shaped to directly receive at least some of a patient'"'"'s teeth and apply a resilient positioning force to the patient'"'"'s teeth, wherein providing the removable orthodontic tooth positioning appliance comprises placing the removable orthodontic tooth positioning appliance on the teeth of the patient, the appliance comprising:

a first soft outer polymer layer comprising a first soft polymeric material and a second soft outer polymer layer comprising a second soft polymeric material, each of the first and second soft polymer layers having a flexural modulus of greater than about 35,000 psi, a hardness of about 60 A to about 85 D, and a thickness in a range from 25 μ

m to 100 μ

m; and

a hard inner polymer layer comprising a co-polyester disposed between the first soft outer polymer layer and the second soft outer polymer layer so as to reduce degradation of the resilient positioning force applied to the teeth when the appliance is worn.

16. The method of claim 15, wherein providing the removable orthodontic tooth positioning appliance comprises providing a series of incremental position adjustment appliances, said series of incremental position adjustment appliances including the removable orthodontic tooth positioning appliance.

17. The method of claim 16, wherein providing the series of incremental position adjustment appliances comprises placing said series of incremental position adjustment appliances over the patient'"'"'s teeth.

18. The method of claim 15, wherein:

the first soft polymeric material comprises a material-selected from;

a thermoplastic polyurethane elastomer, a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a block copolymer elastomer, a polyolefin blend elastomer, a thermoplastic co-polyester elastomer, a thermoplastic polyamide elastomer, or a combination thereof; and

the second soft polymeric material comprises a material selected from;

a thermoplastic polyurethane elastomer, a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a block copolymer elastomer, a polyolefin blend elastomer, a thermoplastic co-polyester elastomer, a thermoplastic polyamide elastomer, or a combination thereof.

19. The method of claim 18, wherein the first soft polymeric material and the second soft polymeric material are different.

20. The method of claim 18, wherein the first and second soft polymeric materials each comprises a blend of polymeric materials, each respective blend including two or more materials selected from the group consisting of:

a thermoplastic polyurethane elastomer, a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a block copolymer elastomer, a polyolefin blend elastomer, a thermoplastic co-polyester elastomer, and a thermoplastic polyamide elastomer.

21. The method of claim 18, wherein the first and second soft polymeric materials each comprises a thermoplastic polyurethane elastomer.

22. The method of claim 15, wherein the hard inner polymer layer comprises a blend of polymeric materials including the co-polyester and one or more of:

a polyester, a thermoplastic polyurethane, a polypropylene, a polyethylene, a polypropylene and polyethylene copolymer, an acrylic, a polyetheretherketone, a polyamide, a polyethylene terephthalate, a polybutylene terephthalate, a polyetherimide, a cyclic block copolymer, a polyethersulfone, a polytrimethylene terephthalate, or a combination thereof.

23. The method of claim 15, wherein the hard inner polymer layer comprises at least two layers including a first layer comprising the co-polyester and a second layer comprising one or more of:

a polyester, a co-polyester, a thermoplastic polyurethane, a polypropylene, a polyethylene, an acrylic, a polyetheretherketone, a polyamide, a polyethylene terephthalate, a polybutylene terephthalate, a polyetherimide, a cyclic block copolymer, a polyethersulfone, or a polytrimethylene terephthalate.

24. The method of claim 15, wherein the first soft outer polymer layer and the second soft outer polymer layer each independently comprises at least one of:

an ultimate tensile strength of greater than about 5000 psi, an elongation at break of greater than about 200%, a compression set at about 70°

C. of greater than 40% after 24 hours, or a light transmission between 400 nm and 800 nm of greater than about 75%.

25. The method of claim 15, further comprising fabricating the removable orthodontic tooth positioning appliance.

26. A method of moving a patient'"'"'s teeth from an initial configuration towards a target configuration, the method comprising the steps of:

providing a removable orthodontic tooth positioning appliance having teeth receiving cavities shaped to directly receive at least some of a patient'"'"'s teeth;

placing the removable orthodontic tooth positioning appliance on the teeth of the patient to apply a resilient positioning force to the patient'"'"'s teeth and thereby move the teeth towards the target configuration;

wherein the appliance comprises;

a first soft outer polymer layer comprising a first soft polymeric material and a second soft outer polymer layer comprising a second soft polymeric material, each of the first and second soft polymer layers having a hardness of about 60 A to about 85 D, and a thickness in a range from 25 μ

m to 100 μ

m; and

a hard inner polymer layer comprising a co-polyester disposed between the first soft outer polymer layer and the second soft outer polymer layer so as to reduce degradation of the resilient positioning force applied to the teeth when the appliance is worn.

27. The method of claim 26, wherein:

the first soft polymeric material comprises a material selected from;

a thermoplastic polyurethane elastomer, a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a block copolymer elastomer, a polyolefin blend elastomer, a thermoplastic co-polyester elastomer, a thermoplastic polyamide elastomer, or a combination thereof; and

the second soft polymeric material comprises a material selected from;

a thermoplastic polyurethane elastomer, a silicone rubber, an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a block copolymer elastomer, a polyolefin blend elastomer, a thermoplastic co-polyester elastomer, a thermoplastic polyamide elastomer, or a combination thereof.