Multilayer dental appliances and related methods and systems

• US 9,655,691 B2
• Filed: 05/14/2012
• Issued: 05/23/2017
• Est. Priority Date: 05/14/2012
• Status: Active Grant

• Current Assignee: Align Technology Incorporated
• Original Assignee: Align Technology Incorporated
• Inventors: Li, Chunhua, Chen, Yan, Meyer, Klaus, Pudleiner, Heinz, Pehlert, Craig, Nickel, Joerg
• Primary Examiner(s): Rodriguez, Cris L
• Assistant Examiner(s): Mai, Hao D
• Application Number:
  US13/470,681
• Publication Number:
  US 20130302742A1
• Time in Patent Office: 1,835 Days
• Field of Search: 433 2, 433 6, 433 18, 433 24, 264 16, 264 17, 264 18
• 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 hard inner polymer layer comprising a co-polyester and having a hard polymer layer elastic modulus; and

a first soft outer polymer layer and a second soft outer polymer layer each comprising a thermoplastic polyurethane elastomer and each having a soft polymer elastic modulus less than the hard polymer layer elastic modulus, a flexural modulus of greater than about 35,000 psi, a hardness of about 60A to about 85D, and a thickness in a range from 25 μ

m to 100 μ

m,

wherein the hard inner polymer layer is 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 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 polyethersulfone, a polytrimethylene terephthalate, or a combination thereof.

3. The appliance of claim 1, wherein the hard inner polymer layer comprises a plurality of co-extruded or laminated polymer layers.

4. 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 polyethersulfone, or a polytrimethylene terephthalate.

5. 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.

6. The appliance of claim 1, wherein each of the first soft outer polymer layer and the second soft outer polymer layer comprises a blend of polymeric materials including the thermoplastic polyurethane elastomer and one or more of:

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

7. The appliance of claim 1, wherein each of the first soft outer polymer layer and the second soft outer polymer layer comprises a blend of polymeric materials including the thermoplastic polyurethane elastomer and one or more of:

an elastomeric alloy, a thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a thermoplastic co-polyester elastomer, or a polyester elastomer.

8. The appliance of claim 1, wherein at least one of the first soft outer polymer layer and the second soft outer polymer layer comprises at least two layers including a first layer comprising the thermoplastic polyurethane elastomer and a second layer selected from the group consisting of:

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

9. The appliance of claim 1, wherein the first soft outer polymer layer and the second soft outer polymer layer each have a thickness in a range from 35 μ

m to 80 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 at 24 hours testing in a high humidity environment of greater than about 10%, 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 comprise 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. The appliance of claim 1, wherein the hard inner polymer layer comprises 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 at 24 hours testing in a high humidity environment of greater than about 10%, and a light transmission between 400 nm and 800 nm of greater than about 75%.

14. The appliance of claim 1, wherein the first soft outer polymer layer and the second soft outer polymer layer each comprise 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, and a light transmission between 400 nm and 800 nm of greater than about 75%.

15. The appliance of claim 1, wherein one or more of the first soft outer polymer layer or the second soft outer polymer layer comprise a plurality of polymer layers.

16. The appliance of claim 1, wherein the first soft outer polymer layer comprises a different material than the second soft outer polymer layer.

17. An orthodontic system for positioning a patient'"'"'s teeth, comprising:

a plurality of incremental position adjustment appliances 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, wherein the appliances are successively worn by a patient to move teeth from one arrangement to a successive arrangement, and wherein at least one of the appliances comprises;

a hard inner polymer layer comprising a co-polyester and having a hard polymer layer elastic modulus; and

a first soft outer polymer layer and a second soft outer polymer layer each comprising a thermoplastic polyurethane elastomer and each having a soft polymer elastic modulus less than the hard polymer layer elastic modulus, a flexural modulus of greater than about 35,000 psi, a hardness of about 60A to about 85D, and a thickness in a range from 25 μ

m to 100 μ

m,

wherein the hard inner polymer layer is 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.

18. The orthodontic system of claim 17, 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 polyethersulfone, or a polytrimethylene terephthalate.

19. The orthodontic system of claim 17, wherein the hard inner polymer layer comprises at least two layers including a first layer comprising the co-polyester and a second layer selected from the group consisting 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 polyethersulfone, and a polytrimethylene terephthalate.

20. The orthodontic system of claim 17, wherein each of the first soft outer polymer layer and the second soft outer polymer layer comprises a blend of polymeric materials including the thermoplastic polyurethane elastomer and one or more of:

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

21. The orthodontic system of claim 17, wherein at least one of the first soft outer polymer layer and the second soft outer polymer layer comprises at least two layers including a first layer comprising the thermoplastic polyurethane elastomer and a second layer selected from the group consisting of:

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

22. The orthodontic system of claim 17, wherein the hard inner polymer layer comprises at least one of:

a tensile strength at yield of between about 4000 pounds 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 at 24 hours testing in a high humidity environment greater than about 10%, or a light transmission between 400 nm and 800 nm of greater than about 75%.

23. The orthodontic system of claim 17, wherein the first soft outer polymer layer and the second soft outer polymer layer each independently comprise 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%.

24. The orthodontic system of claim 17, wherein the hard inner polymer layer comprises 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 at 24 hours testing in a high humidity environment of greater than about 10%, and a light transmission between 400 nm and 800 nm of greater than about 75%.

25. The orthodontic system of claim 17, wherein the first soft outer polymer layer and the second soft outer polymer layer each comprise 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, and a light transmission between 400 nm and 800 nm of greater than about 75%.

26. The orthodontic system of claim 17, wherein one or more of the first soft outer polymer layer or the second soft outer polymer layer comprise a plurality of polymer layers.

27. The orthodontic system of claim 17, wherein the first soft outer polymer layer comprises a different material than the second soft outer polymer layer.

28. An orthodontic appliance for repositioning a patient'"'"'s teeth, the appliance comprising:

a shell having a plurality of teeth receiving cavities shaped to apply a repositioning force to the patient'"'"'s teeth, wherein the shell is formed from a multilayer material configured to reduce degradation of the repositioning force over time when the shell is worn on the patient'"'"'s teeth, the multilayer material comprising;

a first soft polymer layer and a second soft polymer layer each having a compression set greater than 40% after 24 hours at 70°

C., wherein the first and second soft polymer layers each comprise a thermoplastic polyurethane elastomer; and

a single hard polymer layer disposed between the first and second soft polymer layers and having a stress relaxation greater than 10% at 24 hour testing between 90% to 100% humidity, wherein the single hard polymer layer comprises a co-polyester.

29. A plurality of orthodontic appliances as in claim 28, wherein the teeth receiving cavities of each of the plurality of orthodontic appliances are configured to move the patient'"'"'s teeth along a path from a starting position to a final position when the plurality of orthodontic appliances is worn in succession, each appliance of the plurality of orthodontic appliances providing an incremental movement along said path.

30. The orthodontic appliance of claim 28, wherein the shell consists essentially of the multilayer material.

31. The orthodontic appliance of claim 30, wherein the first and second soft polymer layers each consists essentially of the thermoplastic polyurethane elastomer, and the single hard polymer layer consists essentially of the co-polyester.