WSGRDocket No. 22773-826.303
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`PATENT APPLICATION
`
`MULTILAYER DENTAL APPLIANCES AND RELATED METHODS AND SYSTEMS
`
`Inventors:
`
`Assignee:
`
`ChunhuaLI,
`Citizen of US, Residing at
`Cupertino, CA
`
`Yan CHEN,
`Citizen of US, Residing at
`Cupertino, CA
`
`Heinz PUDLEINER,
`Citizen of DE, Residing at
`Krefeld, DE
`
`Klaus MEYER,
`Citizen of DE, Residing at
`Dormagen, DE
`
`Joerg NICKEL,
`Citizen of DE, Residing at
`Dormagen, DE
`
`Craig PEHLERT,
`Citizen of US, Residing at
`Lenox, MA
`
`Align Technology,Inc.
`2820 Orchard Parkway
`San Jose, CA 95134
`
`a Delaware Corporation
`
`Entity:
`
`Large business concern
`
`Wilson Sonsini Goodrich & Rosati
`PROPESSIONAL CORPORATION
`
`650 Page Mill Road
`Palo Alto, CA 94304
`(650) 493-9300 (Main)
`(650) 493-6811 (Facsimile)
`
`Filed Electronically on: July 23, 2018
`
`10067626_1.docx
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`WSGRDocket No. 22773-826.303
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`MULTILAYER DENTAL APPLIANCES AND RELATED METHODS AND SYSTEMS
`
`CROSS-REFERENCE
`
`[0001] This application is a continuation of U.S. Patent Application No. 15/476,622, filed March 31,
`
`2017, which is a continuation of U.S. Patent Application No. 13/470,681, filed May 14, 2012, now
`
`U.S. Patent No. 9,655,691, issued May 23, 2017, the entire contents of each are incorporated herein
`
`by reference.
`
`BACKGROUNDOF THE INVENTION
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`[0002] The present invention generally relates to the field of orthodontics, and more particularly to
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`the design of multilayer dental positioning appliances.
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`[0003] An objective of orthodontics is to move a patient's teeth to positions where function and/or
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`aesthetics are optimized. Traditionally, appliances such as braces are applied to a patient's teeth by a
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`treating practitioner and the set of braces exerts continual force on the teeth and gradually urges
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`them toward their intended positions. Over time and withaseries of clinical visits and reactive
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`adjustments to the braces by the practitioner, the appliances to movethe teeth towardtheirfinal
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`destination.
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`[0004] Morerecently, alternatives to conventional orthodontic treatment with traditional affixed
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`appliances (e.g., braces) have becomeavailable. For example, systems including a series of
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`preformed appliances/aligners have become commercially available from Align Technology,Inc.,
`
`San Jose, CA, underthe trade name Invisalign® System. The Invisalign® System is described in
`
`numerouspatents and patent applications assigned to Align Technology,Inc. including, for example
`
`in U.S. Pat. Nos. 6,450,807, and 5,975,893, as well as on the company's website, which is accessible
`
`on the World Wide Web(see,e.g., the url invisalign.com"). The Invisalign® System includes
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`designing and/or fabricating multiple, and sometimesall, of the aligners to be worn by the patient
`
`before the aligners are administered to the patient and used to reposition the teeth (e.g., at the outset
`
`of treatment). Often, designing and planning a customized treatment for a patient makes use of
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`computer-based 3-dimensional planning/design tools, such as Treat™ software from Align
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`Technology, Inc. The design of the aligners relies on computer modeling ofthe patient’s teeth in a
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`series of planned successive tooth arrangements, and the individual aligners are designed to be worn
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`overthe teeth, such that each aligner exerts force on the teeth and elastically repositions the teeth to
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`each of the planned tooth arrangements.
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`[0005] While recently developed orthodontic treatment technologies, such as those described above,
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`represent a considerable advancementin the field of orthodontics, additional advancements remain
`
`of interest. For example, in some instances it may be advantageous to develop materials that
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`improve properties of the appliances/aligners used for orthodontic treatment. As such, there is a
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`need for shell aligners that can, for example, produce more continuousforce and better bring a
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`patient’s teeth into a desired occlusion.
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`BRIEF SUMMARYOF THE INVENTION
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`[0006] The present invention provides multilayer orthodontic positioning appliances, as well as
`
`related methods and systems. The disclosed multilayer appliances include a removable orthodontic
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`tooth positioning appliance having teeth receiving cavities shapedto directly receive at least some of
`
`the patient’s teeth and apply a resilient positioning force to the patient's teeth. The multilayer
`
`appliances can include a hard polymerlayer disposed between twosoft polymer layers. The
`
`multilayer dental appliances of the present invention, among manyaspects, provide, for example,
`
`improved material performance,stress relaxation properties and longer working range. In addition,
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`the mechanical properties of the materials and appliances described herein can improve orthodontic
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`treatments by, for example, reducing the need for midcourse corrections during treatment and the
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`numberofaligners used for a given treatment.
`
`[0007] The disclosed methods include methods for making multilayer dental appliances. The
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`disclosed systems including a plurality of appliances having teeth receiving cavities shaped to
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`directly receive at least some of the patient’s teeth and apply a resilient positioning force to the
`
`patient's teeth. The appliances can be successively worn by a patient to move teeth from one
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`arrangementto a successive arrangement. At least one of the appliances in the system can include a
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`hard polymerlayer disposed between two soft polymerlayers.
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`[0008] Fora fuller understanding of the nature and advantages of the present invention, reference
`
`should be madeto the ensuing detailed description and accompanying drawings. Other aspects,
`
`objects and advantages of the invention will be apparent from the drawings and detailed description
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`that follows.
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`BRIEF DESCRIPTION OF THE DRAWINGS
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`[0009] Figure 1 illustrates a jaw and an incremental positioning appliance for the jaw, in accordance
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`with an embodimentof the present invention.
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`[0010] Figure 2 shows an arrangementof polymerlayers in a sheet having a hard polymerlayer
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`disposed between two soft polymerlayers, in accordance with an embodimentof the present
`
`invention.
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`[0011] Figure 3 depicts a method of making a multilayer dental appliance, in accordance with an
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`embodimentof the present invention.
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`[0012] Figure 4 is a simplified block diagram illustrating a method for fabricating a dental
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`appliance, in accordance with an embodimentofthe present invention.
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`[0013] Figure 5 provides a stress relaxation comparison for dental appliances, in accordance with an
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`embodimentof the present invention.
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`[0014] Figure 6 provides anotherstress relaxation comparison for dental appliances, in accordance
`
`with an embodimentof the present invention.
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`[0015] Figure 7 showsa long-term unloading comparison for dental appliances, in accordance with
`
`an embodimentof the present invention.
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`[0016] Figure 8 provides a long-term movement comparison for dental appliances, in accordance
`
`with an embodimentof the present invention.
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`DETAILED DESCRIPTION OF THE INVENTION
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`[0017] In the following description, various embodiments of the present invention will be described.
`
`For purposes of explanation, specific configurations and details are set forth in order to provide a
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`thorough understanding of the embodiments. However,it will also be apparent to oneskilled in the
`
`art that the present invention may be practiced without the specific details. Furthermore, well-
`
`knownfeatures may be omitted or simplified in order not to obscure the embodimentbeing
`
`described.
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`[0018] Multilayer orthodontic positioning appliances are provided, as well as related methods and
`
`systems. During orthodontic treatment, it may be necessary to apply forces to a tooth to generate
`
`movementof the tooth to, for example, bring the patient’s teeth into a better occlusion in a mesial or
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`distal direction. The presently disclosed appliances, methods, and systems provide means by which
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`such forces can be applied during orthodontic treatment where appliances having teeth receiving
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`cavities are used, such as preformed appliances/aligners available from Align Technology, Inc., San
`
`Jose, CA, 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 dueto aligner reinsertion and removal and other mechanical
`
`stresses put on the aligner during treatment. In addition, the aligners have improvedelastic
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`properties that allow for less degradation in the shape of the teeth receiving cavities during a stage of
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`treatment. For example, during a multistage orthodontic treatment, the force exerted by an aligner to
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`perform defined tooth movement can degrade and may causethe treatment to include more aligners
`
`to reach a final ideal arrangementand/or result in a mid-course correction that could be prevented by
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`using aligners with improved physical properties, such as those provided herein.
`
`[0019] 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 someof the patient’s
`
`teeth and apply a resilient positioning force to the patient's teeth, the appliance comprising a hard
`
`polymerlayer disposed betweena first soft polymer layer and a second soft polymerlayer.
`
`[0020] In another embodiment, the present invention provides an orthodontic system for positioning
`
`a patient’s teeth. The orthodontic system can include a plurality of incremental position adjustment
`
`appliances having teeth receiving cavities shaped to directly receive at least some ofthe patient’s
`
`teeth and apply a resilient positioning force to the patient's teeth, wherein the appliances are
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`successively worn by a patient to move teeth from one arrangementto a successive arrangement, and
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`wherein at least one of the appliances comprises a hard polymerlayer disposed betweena first soft
`
`polymerlayer and a second soft polymerlayer.
`
`[0021] In yet another embodiment, the present invention provides a method of making a dental
`
`appliance for positioning a patient’s teeth. The method can include providing a sheet comprising a
`
`hard polymerlayer of polymeric material disposed betweena first soft polymer layer and a second
`
`soft polymerlayer, providing a positive model of the patient’s teeth in a target position; and
`
`fabricating an appliance as a negative of the positive model comprising thermoformingthe sheet
`
`overthe positive model.
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`[0022] Referring now to the drawings, in which like reference numerals representlike parts
`
`throughout the several views, Figure 1 provides an appropriate starting point in a detailed discussion
`
`of various embodiments of the present invention with respect to tooth repositioning appliances
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`designed to apply repositioning forces to teeth. A tooth repositioning appliance 10 can be worn by a
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`patient in order to achieve an incremental repositioning of individual teeth in the jaw 12. The
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`appliance can include a shell (e.g., a polymeric shell) having teeth-receiving cavities that receive and
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`resiliently reposition the teeth. In many embodiments, a polymeric appliance can be formed from a
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`sheet of suitable layers of polymeric material. An appliance can fit over all teeth present in an upper
`
`or lowerjaw,or less than all of the teeth. In some cases, only certain teeth received by an appliance
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`will be repositioned by the appliance while other teeth can provide a base or anchor region for
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`holding the appliance in placeas it applies force against the tooth or teeth targeted for repositioning.
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`In some cases, many or most, and evenall, of the teeth will be repositioned at some point during
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`treatment. Teeth that are moved can also serve as a base or anchorfor holding the applianceasit is
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`worn by the patient. Typically, no wires or other means will be provided for holding an appliance in
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`place over the teeth. In some cases, however, it may be desirable or necessary to provide individual
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`anchors on teeth with corresponding receptacles or apertures in the applianceso that the appliance
`
`can apply a selected force on the tooth. Exemplary appliances, including those utilized in the
`
`Invisalign® System, are described in numerous patents and patent applications assigned to Align
`
`Technology,Inc. including, for example, in U.S. Pat. Nos. 6,450,807, and 5,975,893, as well as on
`
`the company's website, which is accessible on the World Wide Web(see, e.g., the url
`
`invisalign.com").
`
`[0023] An appliance can be designed and/or providedas part of a set of a plurality of appliances. In
`
`such an embodiment, each appliance may be configured so a tooth-receiving cavity has a geometry
`
`corresponding to an intermediate or final tooth arrangement intended for the appliance. Thepatient's
`
`teeth can be progressively repositioned from aninitial tooth arrangementto a target tooth
`
`arrangementby placing a series of incremental position adjustment appliances overthe patient's
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`teeth. A target tooth arrangement can be a planned final tooth arrangement selected for the patient's
`
`teeth at the end ofall planned orthodontic treatment. Alternatively, a target arrangement can be one
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`of many intermediate arrangementsfor the patient's teeth during the course of orthodontic treatment,
`
`which may include where surgery is recommended, where inter-proximal reduction (IPR)is
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`appropriate, where a progress check is scheduled, where anchor placementis best, where palatal
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`expansion is desirable, etc. As such, it is understood that a target tooth arrangement can be any
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`planned resulting arrangementfor the patient's teeth that follows one or more incremental
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`repositioning stages. Likewise, an initial tooth arrangement can be anyinitial arrangementfor the
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`patient's teeth that is followed by one or more incremental repositioning stages. The adjustment
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`appliances can be generatedall at the same stageorin sets or batches, e.g., at the beginning of a
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`stage of the treatment, and the patient wears each appliance until the pressure of each appliance on
`
`the teeth can no longerbe felt or has resulted in the maximum amountof expressed tooth movement
`
`for that given stage. A plurality of different appliances(e.g., set) can be designed and even
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`fabricated prior to the patient wearing any appliance of the plurality. After wearing an appliance for
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`an appropriate period of time, the patient replaces the current appliance with the next appliance in
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`the series until no more appliances remain. The appliances are generally not affixed to the teeth and
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`the patient may place and replace the appliances at any time during the procedure(e.g., patient-
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`removable appliances). The final appliance or several appliances in the series may have a geometry
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`or geometries selected to overcorrect the tooth arrangement, i.e., have a geometry which would (if
`
`fully achieved) move individual teeth beyond the tooth arrangement which has beenselected as the
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`"final." Such over-correction may be desirable in orderto offset potential relapse after the
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`repositioning method has been terminated,i.e., to permit movement of individual teeth back toward
`
`their pre-corrected positions. Over-correction may also be beneficial to speed the rate of correction,
`
`i.e., by having an appliance with a geometry that is positioned beyonda desired intermediate orfinal
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`position, the individual teeth will be shifted toward the position at a greater rate. In such cases, the
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`use of an appliance can be terminated before the teeth reach the positions defined by the appliance.
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`[0024] In general, structures, methods and systems of the present invention utilize a multilayer sheet
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`for use in orthodontic appliances. The multilayer sheet can include three layers, in which a hard
`
`polymerlayer is disposed between two soft polymer layers. The multilayer sheets used in the
`
`present invention can be used in making dental aligners having improved durability for use, e.g., to
`
`the elastic properties of the multilayer sheet when formedinto an aligner. In addition, the bonding
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`strength between the layers further improves the durability of the aligners, for example, by
`
`withstanding teeth grinding by a patient.
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`[0025] Figure 2 showsa multilayer structure according to the present invention. As shown, a
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`multilayer sheet 20 can include a three layer structure: a hard polymer layer 24 and two soft polymer
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`layers 22, 26. The hard polymerlayer can be disposed betweena first soft polymer layer and a
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`second soft polymer layer. In some embodiments, the hard polymerlayer can be thicker than either
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`of the soft polymer layers. The soft polymer layers can have the sameor different thicknesses. For
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`example, the hard polymerlayer can range from a thickness of about 550 um to about 750 um. The
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`soft polymer layers can range from a thickness of about 25 um to about 100 um. Multilayer sheets
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`used for making appliances having a hard polymerlayer disposed between twosoft polymerlayers
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`can range from a thickness of about 600 Lum to about 1000 um. In some embodiments, the
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`thicknesses of the various layers can be tailored for a particular stage of treatment for the patient.
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`[0026] Suitable polymeric materials for the hard polymerlayer can include a polyester, a co-
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`polyester, a polycarbonate, a thermoplastic polyurethane, a polypropylene, a polyethylene, a
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`polypropylene and polyethylene copolymer, an acrylic, a cyclic block copolymer, a
`
`polyetheretherketone, a polyamide, a polyethylene terephthalate, a polybutylene terephthalate, a
`
`polyetherimide, a polyethersulfone, a polytrimethylene terephthalate or a combination thereof(e.g., a
`
`blend of at least two of the listed hard polymeric materials). In some embodiments, the hard
`
`polymerlayer of the appliances can include polymeric materials, such as a polycarbonate, a co-
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`polyester, a polyester, and a thermoplastic polyurethane. In some embodiments, the hard layer can
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`be composed of multiple hard layers, e.g., two or three hard polymer layers 24-1, 24-2, 24-N co-
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`extruded to form one hard layer.
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`[0027] The hard polymerlayer of the appliances of the present invention can have a variety of
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`physical properties that can, e.g., improve treatment options for a practitioner. For example,
`
`physical properties such astensile strength, elongation at yield, elongation at break, tensile modulus,
`
`flexural modulus, stress relaxation over time, and light transmission can each be specifically tailored
`
`for a particular application. In some embodiments, the hard polymerlayer of the appliances can
`
`have a physical property of 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
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`break of greater than about 70%, a tensile modulusof greater than about 150,000 psi, a flexural
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`modulus greater than about 150,000 psi, a stress relaxation at 24 hours testing in a wet environment
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`(e.g., between about 90%-100% relative humidity) is greater than 10%, and a light transmission
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`between 400 nm and 800 nm ofgreater than about 75%.
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`[0028] Suitable polymeric materials for the soft polymerlayers of the appliance can include a
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`styrenic block copolymer (SBC), a silicone rubber, an elastomeric alloy, a thermoplastic elastomer
`
`(TPE), a thermoplastic vulcanizate (TPV) elastomer, a polyurethane elastomer, a block copolymer
`
`elastomer, a polyolefin blend elastomer, a thermoplastic co-polyester elastomer, a thermoplastic
`
`polyamide elastomer, or a combination thereof(e.g., a blend of at least two ofthe listed soft
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`polymeric materials). The soft polymer layers can be the same material or a different material. In
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`certain embodiments,the first soft polymer layer and the second soft polymerlayer are the same
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`polymeric material.
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`[0029] The soft polymerlayers of the appliances can havea variety of physical properties. For
`
`example, physical properties such as hardness, ultimate tensile strength, elongation at break, tensile
`
`modulus, compressionset, flexural modulus, and light transmission can each be specifically tailored
`
`for a particular application. In some embodiments, the soft polymerlayers of the appliances can
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`independently have a physical property of at least one of a hardness of about 60A to about 85D, an
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`ultimate tensile strength of greater than about 5000 psi, an elongation at break of greater than about
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`200 %, a compression set at about 70°C of greater than 40% after 24 hours, a flexural modulus of
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`greater than about 35,000 psi, and a light transmission between 400 nm and 800 nmofgreater than
`
`about 75%.
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`[0030] As described herein, the layers of the appliances can include a hard polymerlayer disposed
`
`between two soft polymer layers. In one embodiment, the multilayer appliances can include a hard
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`polymerlayer of one type of material (e.g., a co-polyester), and two soft polymerlayers of other
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`types of material that can be the sameor different (e.g., two soft polymer layers of thermoplastic
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`polyurethane elastomer). In some embodiments, the multilayer appliances can also include a hard
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`polymerlayer of at least two layers of polymer material. For example, the hard polymer layer can
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`include several polymer layers laminated together to form the hard polymerlayer. The laminated
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`hard polymerlayer can includeat least two layers of any combination of the following polymer
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`materials: a polyester, a co-polyester, a polycarbonate, a thermoplastic polyurethane, a
`
`polypropylene, a polyethylene, a polypropylene and polyethylene copolymer, an acrylic, a cyclic
`
`block copolymer, a polyetheretherketone, a polyamide, a polyethylene terephthalate, a polybutylene
`
`terephthalate, a polyetherimide, a polyethersulfone, and a polytrimethylene terephthalate. Similarly,
`
`in some embodiments, the multilayer appliances can include a soft polymerlayer of at least two
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`layers of polymer material. For example, the soft polymer layers 22, 26 can include a layer of
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`several polymer layers 22-1, 22-2, 22-N and 26-1, 26-2, 26-N, respectively, laminated together. The
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`laminated soft polymer layers can includeat least two layers of any combination of the following
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`polymer materials: a styrenic block copolymer (SBC), a silicone rubber, an elastomeric alloy, a
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`thermoplastic elastomer (TPE), a thermoplastic vulcanizate (TPV) elastomer, a polyurethane
`
`elastomer, a block copolymerelastomer, a polyolefin blend elastomer, a thermoplastic co-polyester
`
`elastomer, and a thermoplastic polyamide elastomer.
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`[0031] The tooth positioning appliances can be fabricated using a variety of methods. For example,
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`methods for making the appliances can include thermoforming a multilayer sheet into an aligner by
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`heating the sheet and then molding the sheet to a particular configuration. Exemplary methodsfor
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`fabricating the appliances, including those utilized in the Invisalign® System, are described in
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`numerous patents and patent applications assigned to Align Technology,Inc. including, for example,
`
`in U.S. Appl. No. 13/186,374 as well as on the company's website, which is accessible on the World
`
`Wide Web(see,e.g., the url invisalign.com").
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`[0032] Figure 3 depicts an example embodimentof a process 30 for forming a multilayer tooth
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`positioning appliance, in accordance with an embodimentof the present invention. As shown, a
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`multilayer sheet 32 can be formed into a tooth positioning appliance 36. The multilayer sheet 32, as
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`depicted, can include three layers: a hard polymer layer disposed between twosoft polymerlayers.
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`In this example process, the tooth positioning appliance 36 can be produced with the use of a
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`physical tooth model, or mold, 34. The tooth positioning appliance 36 can be producedby heating
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`the thermoformable multilayer sheet 32 and then vacuum or pressure forming the sheet over the
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`teeth in the physical tooth model 34. The tooth positioning appliance 36 is a direct representation of
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`the physical tooth model. Excess material from the sheet can be trimmed to form a final tooth
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`positioning appliance that can be used for orthodontic treatmentof a patient.
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`[0033] One ora series of physical tooth models, such as the model described above, may be used in
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`the generation of elastic repositioning appliances for orthodontic treatment. Similar to the process
`
`above, each of the appliances can be generated by thermoforming a multilayer polymeric material
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`over a mold of a desired tooth arrangement to form a dental appliance. The tooth positioning
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`appliance of the desired tooth arrangement generally conforms to a patient's teeth butis slightly out
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`of alignment with the initial tooth configuration. Placementof the elastic positioner over the teeth
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`applies controlled forces in specific locations to gradually movethe teeth into the desired
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`configuration. Repetition of this process with successive appliances comprising new configurations
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`eventually moves the teeth through a series of intermediate configurations to a final desired
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`configuration.
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`[0034] The present invention includes a variety of methodsfor fabricating dental appliances. Figure
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`4 showsa simple schematic for a method 40 of fabricating a removable orthodontic tooth positioning
`
`appliance having teeth receiving cavities shaped to directly receive at least someof the patient’s
`
`teeth and apply a resilient positioning force to the patient's teeth, in accordance with an embodiment
`
`of the present invention. The method can include providing a multilayer sheet having a hard
`
`polymerlayer disposed between twosoft polymerlayers (Step 42). The method can further include
`
`providing a positive physical model of a patient’s teeth (Step 44). The tooth positioning appliance
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`can be fabricated by thermoforming the multilayer sheet over the positive physical model (Step 46),
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`in which the tooth positioning appliance is a negative of the positive model. As described above, the
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`methodsof fabrication can further include trimming or cutting portions of the sheet to renderafinal,
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`usable appliance for orthodontic treatment.
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`[0035] Multilayer sheets of the present invention were analyzed and determinedto provide a variety
`
`of improved properties for aligners used in orthodontic treatment. As further described herein, the
`
`multilayer sheets formedinto aligners can, for example, provide increased durability of the aligners
`
`so that they can better withstand wear dueto teeth grinding and other mechanical stresses put on the
`
`aligner during treatment. In addition, the aligners have improvedelastic properties that allow for
`
`less degradation in the shape of the teeth receiving cavities during a stage of treatment. For
`
`example, during a multistage orthodontic treatment, the capability of an aligner to force tooth
`
`movement can degrade and may cause the treatment to include morealigners to reacha final ideal
`
`arrangement and/or result in a mid-course correction that could be prevented by using aligners with
`
`improved physical properties, such as those provided herein.
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`[0036] Figures 5-8 provide example test results that compare various physical properties of the
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`multilayer sheet appliances of the present invention with other already existing aligner materials
`
`(Material 1). Samples of varied thicknesses were tested. For example, multilayer sheets were tested
`
`having a hard polymer layer with thicknesses ranging from about 580 um to about 715 um thick. In
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`some examples, the hard layer was a co-polyester hard polymer layer. The soft layers tested ranged
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`between about 50 um to about 100 um.
`
`In some examples, the hard polymer layer was disposed
`
`between thermoplastic polyurethane elastomer soft polymer layers. As shown in Figures 5 and 6,
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`one example of the multilayer sheet material (Material 2) showed improvedstress relaxation
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`properties as comparedto anotheralready existing material (Material 1) at room temperature and 37
`
`°C. In addition, Figure 7 shows improved long-term unloading characteristics of the multilayer
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`sheet Material 2 versus the already existing Material 1. The multilayer sheet showedless deflection
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`underforce loads. Figure 8 also shows improved long-term movement data for the multilayer sheet
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`Material 2 versus Material 1.
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`[0037] The use of the terms “a” and “an” and “the” and similar referents in the context of describing
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`embodiments (especially in the context of the following claims) are to be construed to cover both the
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`singular and the plural, unless otherwise indicated herein or clearly contradicted by context. The
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`terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended
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`terms(1.e., meaning “including, but not limited to,”) unless otherwise noted. The term “connected”
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`is to be construed as partly or wholly contained within, attached to, or joined together, even if there
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`is something intervening. Recitation of ranges of values herein are merely intendedto serve as a
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`shorthand method ofreferring individually to each separate value falling within the range, unless
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`otherwise indicated herein, and each separate value is incorporated into the specification as if it were
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`individually recited herein. All methods described herein can be performed in any suitable order
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`unless otherwise indicated herein or otherwise clearly contradicted by context. The use of any and
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`all examples, or exemplary language (e.g., “such as”) provided herein, is intended merely to better
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`illuminate embodiments and does not pose a limitation on the scope unless otherwise claimed. No
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`languagein the specification should be construed as indicating any non-claimed elementas essential
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`to the practice of at least one embodiment.
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`[0038] Variations of the embodiments described herein may becomeapparentto those of ordinary
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`skill in the art upon reading the foregoing description. The inventors expect skilled artisans to
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`employ such variations as appropriate, and the inventors intend for embodiments to be constructed
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`otherwise than as specifically described herein. Accordingly, suitable embodiments include all
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`modifications and equivalents of the subject matter recited in the claims appendedhereto as
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`permitted by applicable law. Moreover, any combination of the above-described elementsin all
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`possible variations thereof is contemplated as being incorporated into some suitable embodiment
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`unless otherwise indicated herein or otherwise clearly contradicted by context. The scope of the
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`invention should, therefore, be determined not with reference to the above description, but instead
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`should be determined with reference to the pending claims along with their full scope or equivalents.
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`WSGRDocket No. 22773-826.303
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