`
` (10) International Publication Number
`
`WO 2006/096558 A2
`
`(74) Agents: SHOOP, Rick et a1.; MORRISON & FOERSTER
`LLP, 755 Page Mill Road, Palo Alto, California 943047
`1018 (US).
`
`(81) Designated States (unless otherwise indicated, for every
`kind ofnational protection available): AE, AG, AL, AM,
`AT, AU, AZ, BA, BB, BG, BR, BW, BY, BZ, CA, CH, CN,
`CO, CR, CU, CZ, DE, DK, DM, DZ, EC, EE, EG, ES, FI,
`GB, GD, GE, GH, GM, HR, HU, ID, IL, IN, IS, JP, KE,
`KG, KM, KN, KP, KR, KZ, LC, LK, LR, LS, LT, LU, LV,
`LY, MA, MD, MG, MK, MN, MW, MX, MZ, NA, NG, NI,
`NO, NZ, OM, PG, PH, PL, PT, RO, RU, SC, SD, SE, SG,
`SK, SL, SM, SY, TJ, TM, TN, TR, TT, TZ, UA, UG, US,
`UZ, VC, VN, YU, ZA, ZM, ZW.
`
`(84) Designated States (unless otherwise indicated, for every
`kind of regional protection available): ARIPO (BW, GII,
`GM, KE, LS, MW, lVIZ, NA, SD, SL, SZ, TZ, UG, ZM,
`ZW), Eurasian (AlVl, AZ, BY, KG, KZ, MD, RU, TJ, TM),
`European (AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, Fl,
`FR, GB, GR, IIU, IE, IS, IT, LT, LU, LV, MC, NL, PL, PT,
`RO, SE, SI, SK, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA,
`GN, GQ, GW, ML, MR, NE, SN, TD, TG).
`Published:
`
`without international search report and to be republished
`upon receipt of that report
`
`For two—letter codes and other abbreviations, refer to the ”Guid—
`ance Notes on Codes andAbbreviations” appearing at the begin—
`ning of each regular issue of the PCT Gazette.
`
`(19) World Intellectual Property Organization
`International Bureau
`
`(43) International Publication Date
`14 September 2006 (14.09.2006)
`
`(51) International Patent Classification:
`A6IC 3/00 (2006.01)
`
`(21) International Application Number:
`PCT/US2006/0077 14
`
`(22) International Filing Date:
`
`3 March 2006 (03.03.2006)
`
`(25) Filing Language:
`
`(26) Publication Language:
`
`English
`
`English
`
`(30) Priority Data:
`11/074,297
`11/074,298
`11/074,300
`11/074,301
`11/107,584
`60/676,100
`
`7 March 2005 (07032005)
`7 March 2005 (0703.2005)
`7 March 2005 (0703.2005)
`7 March 2005 (07032005)
`15 April 2005 (15042005)
`29 April 2005 (29042005)
`
`US
`US
`US
`US
`US
`US
`
`(71) Applicant (forall designated States except US): ORTHO-
`CLEAR HOLDINGS, INC.; THE MILL MALL, P.O.
`BOX 92, Wickhams Cay 1, Road Town, Tortola (VG).
`
`(72) Inventors; and
`(75) Inventors/Applicants (for US only): WEN, Huafeng
`[US/US]; 2117 Gossamer Avenue, Redwood City, Cali—
`fornia 94065 (US). LIU, Rank [US/US]; 353 St. Martin
`Street, Redwood City, California 94065 (US).
`
`(54) Title: VARIATIONS OF DENTAL ALIGNERS
`
`
`
`6/096558A2|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
`
`6 W
`
`0
`
`(57) Abstract: Dental appliances for producing corrective movement in a subject’s teeth include dental aligners which may be
`c worn on a subject’s teeth, gingiva or other region of the oral cavity. Described herein are dental appliances that include features that
`N enhance the performance and comfort of the appliance, including features for preventing damage or wear on the appliance. Described
`herein are fluid—permeable aligners, wrinkled aligners, modular aligners, aligners of varying thickness, aligners of varying stiffness,
`snap—on aligners, textured aligners, aligners having multiple layers, and lateral correction aligners. Methods of making and using
`such aligners are also described.
`
`
`
`WO 2006/096558
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`PCT/U52006/007714
`
`VARIATIONS OF DENTAL ALIGNERS
`
`Inventors: Huafeng Wen and Frank Zhenhuan Liu
`
`TECHNICAL FIELD
`
`[0001]
`
`This application generally relates to the field of dental care, and more
`
`particularly to the field of orthodontics.
`
`CROSS—REFERENCES TO RELATED INVENTIONS
`
`[0002]
`
`The present invention claims priority to US patent applications: U.S. Patent
`
`Application Serial No. 11/074,301, titled “Dental Aligner for Providing Accurate Dental
`
`Treatrnen ” by Wen et. al.; US. Patent Application Serial No. 11/074,297, titled
`
`“Producing Wrinkled Dental Aligner for Dental Treatment” by Wen et al.; U.S. Patent
`
`Application Serial No. 11/074,300, titled “Fluid Permeable Dental Aligner” by Huafeng
`
`Wen; U.S. Patent Application Serial No. 11/107,584, titled “Dental Aligner Devices
`
`Having Snap-On Connectors” by Wen et a1.; U.S. Patent Application Serial No.
`
`11/074,298, titled “Disposable Dental Ali gner” by Huafeng Wen; and U.S. Provisional
`
`Patent Application Serial No. 60/676,100, titled “Nonuniform Dental Ali gner and
`
`Methods” by Huafeng Wen. Each of these applications is herein incorporated by reference
`
`in its entirety.
`
`[0003]
`
`Refer also to commonly assigned U.S. Patent applications: U.S. Provisional
`
`Patent Application Serial No. 60/676,546, titled “Digitization of Dental Arch Model
`
`Components” by Huafeng Wen; U.S. Provisional Patent Application 60/673,970, titled
`
`“System for Digitizing and Registering a Subj ect’s Upper and Lower Dental Arches” by
`
`Wen et. al.; and U.S. Patent Application 11/205,496, titled “System for Organizing Dental
`
`Aligners” by Huafeng Wen. Each of these applications is herein incorporated by reference
`
`in its entirety.
`
`[0004]
`
`Refer also to US. Patent Application Serial No. 11/074,301, titled “Dental
`
`aligner for providing accurate dental treatment” by Liu et a1, filed 3/7/2005, U.S. Patent
`
`Application Serial No. 11/074,297, titled “Producing wrinkled dental aligner for dental
`
`treatmen ” by Liu et al, filed 3/7/2005, U.S. Patent Application Seiial No. 11/074,300,
`
`
`
`WO 2006/096558
`
`PCT/U52006/007714
`
`titled “Fluid permeable dental aligner” by Huafeng Wen, filed 3/7/2005, U.S. Patent
`
`Application Serial No. 11/074,298, titled “Disposable dental aligner by Huafeng Wen, filed
`
`3/7/2005, and U.S. Patent Application Serial No. 1 1/05 0,051, titled “Storage system for
`
`dental devices” by Huafeng Wen, filed 2/3/2005. Each of these applications is herein
`
`incorporated by reference in its entirety.
`
`[0005]
`
`Refer also to U.S. Patent Application Serial No. 10/979,823, titled “Method
`
`and apparatus for manufacturing and constructing a physical dental arch model” by
`
`Huafeng Wen, filed 11/2/2004, U.S. Patent Application Serial No. 10/979,497, titled
`
`“Method and apparatus for manufacturing and constructing a dental aligner” by Huafeng
`
`Wen, filed 1 1/2/2004, U.S. Patent Application Serial No. 10/979,504, titled “Producing an
`
`adjustable physical dental arch model” by Huafeng Wen, filed 1 1/2/2004, and U.S. Patent
`
`Application Serial No. 10/979,824, titled “Producing a base for physical dental arch model”
`
`by Huafeng Wen, filed 11/2/2004. Each of these applications is herein incorporated by
`
`reference in its entirety.
`
`[0006]
`
`Refer also to U.S. Patent Application Serial No. 11/013,152, titled “A base
`
`for physical dental arch model” by Huafeng Wen, filed 12/14/2004, U.S. Patent
`
`Application Serial No. 11/012,924, titled “Accurately producing a base for physical dental
`
`arch model” by Huafeng Wen, filed 12/14/2004, US. Patent Application Serial No.
`
`11/013,145, titled “Fabricating a base compatible with physical dental tooth models” by
`
`Huafeng Wen, filed 12/14/2004, U.S. Patent Application Serial No. 11/013,156, titled
`
`“Producing non-interfering tooth models on a base” by Huafeng Wen, filed 12/14/2004,
`
`U.S. Patent Application Serial No. 11/013,160, titled “System and methods for casting
`
`physical tooth model” by Huafeng Wen, filed 12/14/2004, U.S. Patent Application Serial
`
`No. 1 1/013,15 9, titled “Producing a base for accurately receiving dental tooth models” by
`
`Huafeng Wen, filed 12/14/2004, U.S. Patent Application Serial No. 11/013,157, titled
`
`“Producing accurate base for dental arch model” by Huafeng Wen, filed 12/ 14/2004. Each
`
`of these applications is herein incorporated by reference in its entirety.
`
`W
`
`[0007]
`
`Orthodontics is the practice of manipulating a subj ect's teeth to provide
`
`better function and appearance. In general, brackets are bonded to a subj ect's teeth and
`
`coupled together with an arched wire. The combination of the brackets and wire provide a
`
`force on the teeth causing them to move. Once the teeth have moved to a desired location
`
`
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`WO 2006/096558
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`PCT/US2006/007714
`
`and are held in a place for a certain period of time, the body adapts bone and tissue to
`
`maintain the teeth in the desired location. To further assist in retaining the teeth in the
`
`desired location, a subject may be fitted with a retainer.
`
`[0008]
`
`To achieve tooth movement, orthodontists utilize their expertise to first
`
`determine a three—dimensional mental image of the subj ect's physical orthodontic structure
`
`and a three~dimensional mental image of a desired physical orthodontic structure for the
`
`subject, which may be assisted through the use of x—rays and/or models. Based on these
`
`mental images, the orthodontist further relies on his/her expertise to place the brackets
`
`and/or bands on the teeth and to manually bend (i.e., shape) Wire, such that a force is
`
`asserted on the teeth to reposition the teeth into the desired physical orthodontic structure.
`
`As the teeth move towards the desired location, the orthodontist makes continual judgments
`
`as to the progress of the treatment, the next step in the treatment (e.g., new bend in the
`
`wire, reposition or replace brackets, is head gear required, etc), and the success of the
`
`previous step.
`
`[0009]
`
`In general, the orthodontist makes manual adjustments to the wire and/or
`
`replaces or repositions brackets based on his or her expert opinion. Unfortunately, in the
`
`oral environment, it is difficult for a human being to accurately develop a visual three—
`
`dimensional image of an orthodontic structure due to the limitations of human sight and the
`
`physical structure of a human mouth. In addition, it is difficult (if not impossible) to
`
`accurately estimate three—dimensional Wire bends (with accuracy within a few degrees) and
`
`to manually apply such bends to a wire. Further, it is difficult (or impossible) to determine
`
`an ideal bracket location to achieve the desired orthodontic structure based on the mental
`
`images. It is also extremely difficult to manually place brackets in What is estimated to be
`
`the ideal location. Accordingly, orthodontic treatment is an iterative process requiring
`
`multiple wire changes, with the success and speed of the process being dependent on the
`
`orthodontist's motor skills and diagnostic expertise. As a result of multiple wire changes,
`
`cost and subject discomfort is increased. The quality of care may also vary greatly from
`
`orthodontist to orthodontist, as does the time to treat a subject.
`
`[0010]
`
`The practice of orthodontic is very much an art, relying on the expert
`
`opinions and judgments of the orthodontist. In an effort to shift the practice of orthodontic
`
`from an art to a science, many innovations have been developed. For example, US. Pat.
`
`No. 5,518,397 issued to Andreiko, et. a1. provides a method of forming an orthodontic
`
`brace. Such a method includes obtaining a model of the teeth of a patient's mouth and a
`
`
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`WO 2006/096558
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`PCT/US2006/007714
`
`prescription of desired positioning of such teeth. The contour of the teeth of the patient's
`
`mouth is determined, from the model. Calculations of the contour and the desired
`
`positioning of the patient's teeth are then made to determine the geometry (e. g, grooves or
`
`slots) to be provided. Custom brackets including a special geometry are then created for
`
`receiving an arch Wire to form an orthodontic brace system. Such geometry is intended to
`
`provide for the disposition of the arched wire on the bracket in a progressive curvature in a
`
`horizontal plane and a substantially linear configuration in a vertical plane. The geometry
`
`of the brackets is altered, (e.g., by cutting grooves into the brackets at individual positions
`
`and angles and with particular depth) in accordance with such calculations of the bracket
`
`geometry. In such a system, the brackets are customized to provide three—dimensional
`
`movement of the teeth, once the wire, which has a two dimensional shape (i.e., linear shape
`
`in the vertical plane and curvature in the horizontal plane), is applied to the brackets.
`
`[001 1]
`
`Other innovations relating to bracket and bracket placements have also been
`
`described. For example, such patent innovations are disclosed in U.S. Pat. No. 5,618,716
`
`entitled "Orthodontic Bracket and Li gature,” which describes a method of ligating arch
`
`Wires to brackets, U.S. Pat. No. 5,011,405 "Entitled Method for Determining Orthodontic
`
`Bracket Placement," U.S. Pat. No. 5,395,238 entitled "Method of Forming Orthodontic
`
`Brace," and U.S. Pat. No. 5,533,895 entitled "Orthodontic Appliance and Group
`
`Standardize Brackets therefore and methods of making, assembling and using appliance to
`
`straighten teet ".
`
`[0012]
`
`Kuroda et a1. (l996)rArn. J. Orthodontics 110:365-369 describes a method
`
`for laser scanning a plaster dental cast to produce a digital image of the cast. See also U.S.
`
`Pat. No. 5,605,459. U.S. Pat. Nos. 5,533,895; 5,474,448; 5,454,717; 5,447,432; 5,431,562;
`
`5,395,23 8; 5,368,478; and 5,139,419, assigned to Ormco Corporation, which describe
`
`methods for manipulating digital images of teeth for designing orthodontic appliances.
`
`[0013]
`
`U.S. Pat. No. 5,011,405 describes a method for digitally imaging a tooth and
`
`determining optimum bracket positioning for orthodontic treatment. Laser seaming of a
`
`molded tooth to produce a three-dimensional model is described in U.S. Pat. No. 5,338,198.
`
`U.S. Pat. No. 5,452,219 describes a method for laser scanning a tooth model and milling a
`
`tooth mold. Digital computer manipulation of tooth contours is described in U.S. Pat. Nos.
`
`5,607,305 and 5,587,912. Computerized digital imaging of the arch is described in U.S.
`
`Pat. Nos. 5,342,202 and 5,340,309.
`
`
`
`WO 2006/096558
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`PCT/US2006/007714
`
`[0014]
`
`Other patents of interest include US. Pat. Nos. 5,549,476; 5,3 82,164;
`
`5,273,429; 4,936,862; 3,860,803; 3,660,900; 5,645,421; 5,055,039; 4,798,534; 4,856,991;
`
`5,035,613; 5,059,118; 5,186,623; and 4,755,139.
`
`Efficiency in treatment and maximum quality in results may depend on a
`[0015]
`realistic simulation of the treatment process. Plaster models of the upper and lower arch
`
`may be made, the model may be cut into single tooth models and these tooth models can be
`
`stuck into a wax bed, in a desired position, to create a “set—up.” This approach allows
`
`modeling of a perfect occlusion without any guessing. The next step is to bond a bracket at
`
`every tooth model. This would tell the orthodontist the geometry of the Wire to run through
`
`the bracket slots to receive exactly this result. Then the bracket position may be transferred
`
`to the original malocclusion model. To make sure that the brackets will be bonded at
`
`exactly this position at the real patient's teeth, small templates for every tooth would have
`
`to be fabricated that fit over the bracket and a relevant part of the tooth and allow for
`
`reliable placement of the bracket on the patient's teeth. To increase efficiency of the
`
`bonding process, another option would be to place each single bracket onto a model of the
`
`malocclusion and then fabricate one single transfer tray per arch that covers all brackets
`
`and relevant portions of every tooth. Using such a transfer tray guarantees a very quick and
`
`yet precise bonding using indirect bonding.
`
`[0016]
`
`US. Pat. No. 5,431,562 to Andreiko et a1. describes a computerized,
`
`appliance—driven approach to orthodontics. In this method, first certain shape information
`
`of teeth is acquired. A uniplanar target archform is calculated from the shape information.
`
`The shape of customized bracket slots, the bracket base, and the shape of the orthodontic
`
`archwire, are calculated in accordance with a mathematically—derived target archform. The
`
`goal of the Andreiko et a1. method is to give more predictability, standardization, and
`
`certainty to orthodontics by replacing the human element in orthodontic appliance design
`with a deterministic, mathematical computation of a target archform and. appliance design.
`
`Hence the '5 62 patent teaches away from an interactive, computer—based system in which
`
`the orthodontist remains fully involved in patient diagnosis, appliance design, and
`
`treatment planning and monitoring.
`
`[0017]
`
`Align Technologies recently began offering transparent, removable aligning
`
`devices as a new treatment modality in orthodontics. In this system, an impression model of
`
`the dentition of the patient is obtained by the orthodontist and shipped to a remote
`
`appliance—manufacturing center, where it is scanned with a CT scanner. A computer model
`
`M
`
`
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`WO 2006/096558
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`PCT/US2006/007714
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`of the dentition in a target situation is generated at the appliance~manufacturing center and
`
`made available for Viewing to the orthodontist over the Internet. The orthodontist indicates
`
`changes they wish to make to individual tooth positions. Later, another virtual model is
`
`provided over the Internet and the orthodontist reviews the revised model, and indicates
`
`any further changes. After several such iterations, the target situation is agreed upon. A
`
`series of removable aligning devices or shells are manufactured and delivered to the
`
`orthodontist. The shells, in theory, Will move the patient's teeth to the desired or target
`
`position.
`
`[0018]
`
`US Patent 6,699,037 by Align Technologies describes an improved methods
`
`and systems for repositioning teeth from an initial tooth arrangement to a final tooth
`
`arrangement. Repositioning is accomplished With a system comprising a series of
`
`appliances configured to receive the teeth in a cavity and incrementally reposition
`
`individual teeth in a series of at least three successive steps, usually including at least four
`
`successive steps, often including at least ten steps, sometimes including at least twenty—five
`
`steps, and occasionally including forty or more steps. Most often, the methods and systems
`
`will reposition teeth in from ten to twenty—five successive steps, although complex cases
`
`involving many ofthe patient's teeth may take forty or more steps. The successive use of a
`
`number of such appliances permits each appliance to be configured to move individual
`
`teeth in small increments, typically less than 2 mm, preferably less than 1 mm, and more
`
`preferably less than 0.5 mm. These limits refer to the maximum linear translation of any
`
`point on a tooth as a result of using a single appliance. The movements provided by
`
`successive appliances, of course, will usually not be the same for any particular tooth.
`
`Thus, one point on a tooth may be moved by a particular distance as a result of the use of
`
`one appliance and thereafter moved by a different distance and/or in a different direction by
`
`a later appliance.
`
`[0019}
`
`The individual appliances will preferably comprise a polymeric shell having
`
`the teeth—receiving cavity formed therein, typically by molding as described below. Each
`
`individual appliance will be configured so that its tooth-receiving cavity has a geometry
`
`corresponding to an intermediate or end tooth arrangement intended for that appliance.
`
`That is, when an appliance is first worn by the patient, some of the teeth will be misaligned
`
`relative to an undeformed geometry of the appliance cavity. The appliance, however, is
`
`sufficiently resilient to accommodate or conform to the misaligned teeth, and will apply
`
`
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`WO 2006/096558
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`PCT/US2006/007714
`
`sufficient resilient force against such misaligned teeth in order to reposition the teeth to the
`
`intennediate or end arrangement desired for that treatment step.
`
`[0020]
`
`The fabrication of aligners by Align Technologies utilizes stereo lithography
`
`process as disclosed in US patents 6471,511 and 6,682,346. Several drawbacks exist
`
`however with the stereo lithography process. The materials used by stereo lithography
`
`process may be toxic and harmful to human health. Stereo lithography process builds the
`
`aligner layer by layer by layer, which may create room to hide germs and bacteria while it
`
`is worn by a patient. Furthermore, stereo lithography process used by Align Technology
`
`also requires a different aligner mold at each stage of the treatment, which produces a lot of
`
`waste and is environmental unfriendly. There is therefore a long felt need for practical,
`
`effective and efficient methods to produce a dental aligner.
`
`[0021]
`
`Another challenge for orthodontic treatment using removable dental aligning
`
`devices is that dental aligners often deform or otherwise loose their shape with age, use
`
`and/or environment. For example, a dental aligner (e.g., a “shell”) may be deformed by
`
`chewing, biting, and hot beverages during wearing by the patient. The deformation can
`
`affect the proper function of the removable dental aligning device, because the ability of
`
`the aligner to effectively move teeth may depend upon the contact that the aligner makes
`
`with the teeth.
`
`[0022]
`
`Furthermore, dental aligners may become relaxed and open up after repeated
`
`usage by a patient, which causes a loss of corrective forces applied by the aligner to the
`
`patient’s teeth. This results in insufficient or inaccurate teeth movement and costly
`
`corrective measures in the orthodontic treatment.
`
`[0023]
`
`Another difficulty with the current removable dental aligning devices is that
`
`the narrow tolerance for the removable dental aligning devices to fit to the patient’s teeth.
`
`The removable dental aligning devices have to be produced very close to the surface
`
`profiles of the patient’s teeth. Mismatch between the removable dental aligning devices and
`
`patient’s teeth often produce discomfort in wearing the removable dental aligning devices.
`
`[0024]
`
`Existing aligner have not adequately addresses these problems. For
`
`example, US. Patent 4,793,803 by Martz discloses separate appliances insertable in and
`
`removable from the upper and lower jaws of the subject to correct minor malocclusions.
`
`Martz describes: (a) a fairly rigid portion which mates with or securely grips the tooth
`
`surface, (b) a rigid portion to provide the base and shape, and (c) an intermediate, flexible
`
`resilient portion interposed between (a) and (b) which biases the teeth into the desired
`
`
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`WO 2006/096558
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`PCT/US2006/007714
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`position. The rigidity of the rigid portion may vary depending on the condition of an
`
`individual case. In some instances the rigid portion need only be somewhat flexible,
`
`thereby performing the function of the intermediate portion as well.
`
`[0025]
`
`US Patent 6,309,215 by Phan et a1. describes systems and methods for
`
`removably attaching a dental positioning appliance to the teeth of a subject during
`
`orthodontic treatment. Such removable dental positioning appliances are often preferred
`
`over conventional braces for tooth repositioning due to comfort, appearance and ease of
`
`use. These appliances apply force to specific surfaces of the teeth to cause directed
`
`movement. However, the type of movement and amount of force applied is usually
`
`dependent on the surface characteristics and positions of connection to the teeth. The
`
`appliances or connection between the appliance and the teeth may not provide sufficient
`
`anchoring to impart a desired force on the teeth to be repositioned. Thus, such systems may
`
`require the use of one or more attachment devices that may be positioned on the teeth to
`
`provide the appropriate physical features. Appliances may attach to a subject’s teeth by
`
`interactions with a pit or dimple on the dental aligning devices are often not secure enough,
`
`especially when large teeth movements are required. Furthermore, over a period of usage
`
`by a subject, an aligner can also become relaxed and open up. Dental aligning devices that
`
`attach to the subject’s teeth by dimples may slip over the attachment, which can result in
`
`inaccurate teeth movement and costly corrective measures in the orthodontic treatment.
`
`However, specific design and location of these attachment devices may provide more
`effective repositioning forces, anchoring ability and appliance retention.
`
`[0026]
`
`Another issue with most commercially available removable aligning devices
`
`(e.g., the devices manufactured by Align Technologies) is that the aligning devices do not
`
`allow oxygen to pass through them. A typical treatment takes about 1 8 to 24 months, and
`
`during this interval the cervical lines of the patient wearing such appliances typically
`
`remain covered for the major part of the day without letting air to pass through them.
`
`Oxygen cannot reach the cells of the cervical lines, and air trapped inside the aligning
`
`appliances cannot readily escape. Anaerobic bacteria such as Fusobacterium and
`
`Actinomyces often thrive in an oxygen—deprived environment and may produce volatile
`
`sulfiir compounds (VSC) as byproducts, which can result in bad breath (halitosis) and
`
`hygiene problems in the patient’s mouth.
`
`[0027]
`
`In addition to the problems identified above, many aligners are also limited
`
`in their ability to effect corrections requiring lateral expansion of the palate. Most
`
`
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`WO 2006/096558
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`PCT/US2006/007714
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`presently available aligners move only the teeth, with only minimal impact on the motion
`
`of the palate. Further, traditional devices for expanding the palate are difficult to
`
`manufacture, and are incapable of correcting the entire upper dental arch. For example, US
`
`Patent application Serial Number 10/636,313 to McSurdy (herein incorporated by reference
`
`in its entirety) describes a palatal expansion device. Thus, it would be desirable to provide
`
`an economical, easily fabricated aligner capable of reforming the entire upper dental arch,
`
`including the palate.
`
`[0028]
`
`The devices, systems, and methods described herein illustrate removable
`
`dental aligners having one or more features addressing at least some of the problems
`
`described above. In particular described herein are variations of dental aligners including
`
`dental aligners having through~holes through which connectors securable to a subject’s
`
`teeth may pass and be secured, dental aligners including controllably deformable regions or
`
`textured surfaces (eg, wrinkled aligners), non—unifonn and/or multilayer dental aligners,
`
`and dental aligners which are fluid and/or gas permeable. Any or all of these features may
`
`be combined to form a dental aligner, as described more fully below.
`
`SUMMARY OF THE INVENTION
`
`[0029]
`
`Described herein are systems, methods and devices to correct or modify the
`
`position of a subj ect’s teeth. Methods of manufacturing such apparatuses are also
`
`described. In particular dental appliances are described. Any of the variations of dental
`
`appliances, as well as methods of designing, fabricating, and using them are illustrated.
`
`Dental appliances may be any appropriate dental device, including dental aligners. The
`
`term dental aligner may also generally refer to any appropriate dental appliance.
`
`[0030]
`
`Any of the features described (e. g., snap—on dental aligners, textured, fluid-
`
`and/or gas~ permeable, wrinkled, modular, or varying thickness, stiffiiess or other
`
`properties) may be incorporated as part of a dental aligner, individually or in any
`
`reasonable combination. For purposes of descriptive convenience only, individual dental
`
`aligners are described or illustrated to emphasize only one or a few features. This
`
`arrangement is not intended to be limiting or to imply that the aligners, system, and
`
`methods of making or using these aligners are restricted to the examples shown or
`
`described.
`
`[0031]
`
`Dental aligners may incorporate features that assist in securing the dental
`
`aligner to a subj ect’s teeth, for helping the aligner maintain its conformation or resisting
`
`
`
`WO 2006/096558
`
`PCT/US2006/007714
`
`wear and relaxation, and for improving the comfort and effectiveness of the aligner. For
`
`example, the dental aligner may be a “snap—on” dental aligner (which may be secured to
`
`connectors on a subj ect’s teeth). The dental aligners may be fluid permeable. The dental
`
`aligners may be non—uniform and/or may be multi—layered dental aligners. The dental
`
`aligners may be textured or shaped to permit a predictable expansion or contraction of the
`
`dental aligner. For example, the dental aligner may be a wrinkled aligner.
`
`[0032]
`
`[0033]
`
`Snap—on dental aligners may include one or more of the following.
`
`Snap—on dental aligners may produce corrective movement in a subject’s
`
`teeth, and may include a dental aligner (or shell) configured to be worn on a subject’s teeth,
`
`and one or more through-holes passing through the device. The aligner device includes a
`
`shell portion having an outer surface and an inner surface, wherein at least a portion of the
`
`inner surface is configured to contact the subject’s tooth. Thus, the thorough—holes extend
`
`firom the outer surface to the inner surface of the shell portion of the dental device. The
`
`through—hole is configured to mate With a connector.
`
`[0034}
`
`A system for producing corrective movement in a subject’s teeth may
`
`includes a dental aligner device having one or more through—holes, configured to be worn
`
`on the subject’s teeth, and one or more connectors that are configured to be fixed to the
`
`subject’s teeth. The connectors are configured to engage with the through—holes when the
`
`dental aligner is worn on the subject’s teeth.
`
`[0035]
`
`A system for producing a snap~on dental aligner for dental treatment may
`
`include a guide to indicate the location where through~holes (corresponding to connectors
`
`on the subject) are to be formed on a dental aligner, and a positioner (a positioning device)
`
`to position a hole—maker with respect to the dental aligner based on the information
`
`provided by the guide. In some variations, the system also includes a hole—maker to
`
`produce through—holes in the dental aligner at the positions indicated by the guide to
`
`produce the snap—on dental aligner.
`
`[003 6]
`
`A method for moving a subj ect’s teeth in a dental treatment may comprise
`
`fabricating a dental a1i gner to be worn on the subj ect’s teeth, producing one or more
`
`through—holes in the dental aligner, fixing one or more connectors on the subj ect’s teeth to
`
`engage the through—holes, and engaging the one or more connectors on the subject’s teeth
`
`with the through—holes of the dental aligner to secure the dental aligner on the subj ect’s
`
`teeth.
`
`10
`
`
`
`WO 2006/096558
`
`PCT/US2006/007714
`
`[0037]
`
`Embodiments described herein may provide practical methods and systems
`
`for making dental aligners (e.g., snap—on dental aligners) and associated receiving
`
`connectors on the subj ect’s teeth. The aligners can be attached onto the subj ect’s teeth and
`
`assure the dental aligner to be in precise registration as designed throughout the period of
`
`wearing by the subject. The aligners may also overcome the aligner relaxation problem due
`
`to repeated uses. which is common in prior art dental aligners. The snap—on dental aligner
`
`therefore can ensure that the aligner produces the correct force to achieve a desirable
`
`movement in the subject’s teeth, which improves the accuracy and effectiveness of the
`
`orthodontic treatment by the aligner.
`
`[0038]
`
`One disclosed mechanisms in the dental aligners described include through—
`
`holes in the dental aligners and connectors fixed on a subject’s teeth to receive the through—
`
`holes. The disclosed mechanisms allow the dental aligners to be effectively locked into
`
`intended positions during wearing by the subject. The registration and holding capability
`
`may thus be significantly enhanced.
`
`[0039]
`
`The snap—on dental aligners may also lengthen the usage lifetime of an
`
`aligner by sustaining corrective forces for a longer period of time. As a result, the number
`
`of Visits to the dentist office may be reduced. The material and manufacture costs of the
`
`aligners for an orthodontic treatment may be decreased. The need for corrective rework due
`
`to aligner deformation may also be significantly reduced, which may further reduce costs of
`
`the orthodontic treatment.
`
`[0040]
`
`Snap—on dental aligners may allow a thinner dental aligner while still
`
`engaging that subject’s teeth and providing sustainable forces to cause teeth movement.
`
`Thinner and lower profiled removable dental aligners are less intrusive to subject’s mouth
`
`and often more comfortable for the subject to wear. Snap—on dental aligners may be
`
`applicable to class II bite corrections in dental treatment.
`
`[0041]
`
`The properties of the snap—on aligners may also be simulated and optimized
`
`in the design process. The performance of the snap—on aligners can be optimized by varying
`
`parameters such as the number, the locations, and the density of the snap—on connectors,
`
`and the sizes and locations of the through—holes in the snap-on mechanisms, etc. The snap—
`
`on dental aligners can

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