Abstract:
The present invention provides systems and methods for providing dental appliances, particularly orthodontic appliances, to a patient wherein the patient is easily able to determine the order or sequence in which the appliances should be worn. Typically the appliances are to be worn in a particular sequence to provide desired treatment, such as a progressive movement of teeth through a variety of arrangements to a final desired arrangement.

Description:
CROSS-REFERENCES TO RELATED APPLICATIONS  
       [0001]     NOT APPLICABLE  
       STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT  
       [0002]     NOT APPLICABLE  
       REFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAM LISTING APPENDIX SUBMITTED ON A COMPACT DISK  
       [0003]     NOT APPLICABLE  
       BACKGROUND OF THE INVENTION  
       [0004]     1. Field of the Invention  
         [0005]     The present invention is related generally to the field of orthodontics. More particularly, the present invention is related to methods and systems for dispensing a series of orthodontic appliances in a sequence to a patient.  
         [0006]     Repositioning teeth for aesthetic or other reasons is accomplished conventionally by wearing what are commonly referred to as “braces.” Braces comprise a variety of appliances such as brackets, archwires, ligatures, and O-rings. Attaching the appliances to a patient&#39;s teeth is a tedious and time consuming enterprise requiring many meetings with the treating orthodontist. Consequently, conventional orthodontic treatment limits an orthodontist&#39;s patient capacity and makes orthodontic treatment quite expensive. Moreover, from the patient&#39;s perspective, the use of braces is unsightly, uncomfortable, presents a risk of infection, and makes brushing, flossing, and other dental hygiene procedures difficult.  
         [0007]     As a result, alternative methods and systems for repositioning teeth have been developed. For example, repositioning may be 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. Most often, the methods and systems reposition teeth in from ten to twenty-five successive steps, although complex cases involving many of the patient&#39;s teeth may take forty or more steps. The individual appliances are typically comprised of a polymeric shell having the teeth-receiving cavity formed therein, typically by molding. The successive use of a number of such appliances permits each appliance to be configured to move individual teeth in small increments.  
         [0008]     Typically the systems are planned and all individual appliances are fabricated at the outset of treatment. Thus, the appliances may be provided to the patient as a single package or system. The order in which the appliances are to be used can be marked by sequential numbering directly on the appliances or on tags, pouches or other items which are affixed to or which enclose each appliance so that the patient can place the appliances over his or her teeth in an order and at a frequency prescribed by the orthodontist or other treating professional. Successive appliances will be replaced when the teeth either approach (within a preselected tolerance) or have reached the target end arrangement for that stage of treatment, typically being replaced at an interval in the range from 2 days to 20 days, usually at an interval in the range from 5 days to 10 days.  
         [0009]     In general, it is preferable to simplify procedures for the patient to increase patient compliance and reduce patient errors in carrying out the treatment protocol. Therefore, it is desirable to utilize a packaging or ordering system which will provide appliances to a patient in a manner which is clearly discernable to the patient the order of the appliances. In addition, such packaging or ordering system should be amenable to mid-treatment changes to the treatment protocol, possibly adding or eliminating appliances after the initial set of appliances has been produced and packaged. At least some of these objectives will be met by the methods and systems of the present invention described hereinafter.  
         [0010]     2. Description of the Background Art  
         [0011]     Tooth positioners for finishing orthodontic treatment are described by Kesling in the  Am. J. Orthod. Oral. Surg.  31:297-304 (1945) and 32:285-293 (1946). The use of silicone positioners for the comprehensive orthodontic realignment of a patient&#39;s teeth is described in Warunek et al. (1989)  J. Clin. Orthod.  23:694-700. Clear plastic retainers for finishing and maintaining tooth positions are commercially available from R AINTREE  E ssix , I NC ., New Orleans, La. 70125, and T RU -T AIN  P LASTICS , Rochester, Minn. 55902. The manufacture of orthodontic positioners is described in U.S. Pat. Nos. 5,186,623; 5,059,118; 5,055,039; 5,035,613; 4,856,991; 4,798,534; and 4,755,139.  
         [0012]     Other publications describing the fabrication and use of dental positioners include Kleemann and Janssen (1996)  J. Clin. Orthodon.  30:673-680; Cureton (1996)  J. Clin. Orthodon.  30:390-395; Chiappone (1980)  J. Clin. Orthodon.  14:121-133; Shilliday (1971)  Am. J. Orthodontics  59:596-599; Wells (1970)  Am. J. Orthodontics  58:351-366; and Cottingham (1969)  Am. J. Orthodontics  55:23-31.  
       BRIEF SUMMARY OF THE INVENTION  
       [0013]     The present invention provides systems and methods for providing dental appliances, particularly orthodontic appliances, to a patient wherein the patient is easily able to determine the order or sequence in which the appliances should be worn. Typically the appliances are to be worn in a particular sequence to provide desired treatment, such as a progressive movement of teeth through a variety of arrangements to a final desired arrangement.  
         [0014]     In a first aspect of the present invention, a system of dental appliances is provided comprising a plurality of dental appliances wherein at least some of the plurality include a non-numeric indicia designating an order in which each of the at least some of the plurality are to be worn by a patient to provide dental treatment. Typically, each of the plurality of dental appliances comprise a polymeric shell having cavities shaped to receive and resiliently reposition teeth from one arrangement to a successive arrangement. Exemplary embodiments of such dental appliances are described in U.S. Pat. No. 5,975,893, incorporated herein by reference for all purposes. In some embodiments, each of the polymeric shells has at least one terminal tooth cavity and the indicia comprises a terminal tooth cavity of differing length in each of the polymeric shells. In other embodiments, each of the polymeric shell has a height and the indicia comprises a different height in each of the polymeric shells.  
         [0015]     In still other embodiments, the indicia comprises one or more cutouts so that each polymeric shell has a different cutout pattern. Sometimes the cutout comprises a notch in an edge of the appliance.  
         [0016]     In yet other embodiments, the indicia comprises a color wherein each appliance has different color. The color of the appliances may have the same hue and vary by intensity, for example. The color may comprise a dissolvable dye. Or, the system may further comprise a wrapper removably attachable to each of the appliances, wherein each wrapper has the color.  
         [0017]     In another aspect of the present invention, a system of packaged dental appliances is provided comprising a plurality of packages each containing a dental appliance, wherein the plurality of packages are joined in a continuous chain designating an order in which each of the dental appliances are to be worn by a patient to provide dental treatment. In some instances, the packages are each joined by a perforation wherein the packages can be separated by breaking the perforation. In other instances, the packages are joined by, for example, a heat seal. Further, the system may include a marking on a package at an end of the chain indicating the dental appliance to be worn first. Again, each of the plurality of dental appliances may comprise a polymeric shell having cavities shaped to receive and resiliently reposition teeth from one arrangement to a successive arrangement.  
         [0018]     In a further aspect of the present invention, a system of dental appliances is provided comprising a plurality of dental appliances to be worn by a patient to provide dental treatment, and a framework, wherein each of the plurality of dental appliances are removably attached to a portion of the framework. In some embodiments, each of the plurality of dental appliances comprise a polymeric shell having cavities shaped to receive and resiliently reposition teeth from one arrangement to a successive arrangement. Further, the system may comprise at least one marking on the framework indicating the order in which the appliances are to be worn by a patient.  
         [0019]     In still another aspect of the present invention, method of dispensing dental appliances to a patient is provided. The method including the step of providing a plurality of packages wherein each of the packages includes a polymeric shell having cavities shaped to receive and resiliently reposition teeth from one arrangement to a successive arrangement, the plurality of package including a first package containing a first shell to be worn by the patient to reposition the teeth from the one arrangement to the successive arrangement and a second package containing a second shell to be worn by the patient to reposition the teeth from the successive arrangement to another successive arrangement. The method further including the steps of delivering the first package to the patient at a designated time through a remote delivery system, and delivering the second package to the patient at a later designated time through the remote delivery system. In most embodiments, the remote delivery system comprises a mail delivery system.  
         [0020]     In another aspect of the present invention, a method is provided of dispensing dental appliances to a patient including providing a dispenser including a plurality of dental appliances, wherein each of the appliances comprises a polymeric shell having cavities shaped to receive and resiliently reposition teeth from one arrangement to a successive arrangement, the plurality of appliances including a first shell to be worn by the patient to reposition the teeth from the one arrangement to the successive arrangement and a second shell to be worn by the patient to reposition the teeth from the successive arrangement to another successive arrangement, and removing the first shell from the dispenser wherein removal of the first shell dispenses the second shell.  
         [0021]     In a further aspect of the present invention, a method of dispensing dental appliances to a patient is provided including providing a dispenser including a plurality of dental appliances, wherein each of the appliances comprises a polymeric shell having cavities shaped to receive and resiliently reposition teeth from one arrangement to a successive arrangement, the plurality of appliances including a first shell to be worn by the patient to reposition the teeth from the one arrangement to the successive arrangement and a second shell to be worn by the patient to reposition the teeth from the successive arrangement to another successive arrangement. The method further includes removing the first shell from the dispenser, and actuating an actuator that subsequently dispenses the second shell. In most embodiments, the actuator comprises a lever, knob, or button. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0022]      FIG. 1  is a schematic illustration of a series of appliances dispensed in a chain.  
         [0023]      FIG. 2  illustrates a series of appliances disposed on a framework.  
         [0024]      FIG. 3  illustrates a series of appliances provided to a patient in a dispenser.  
         [0025]      FIGS. 4A-4B  illustrate a change in length of a terminal tooth cavity between appliances in a series.  
         [0026]      FIGS. 5A-5B  illustrate a change in height between appliances in a series.  
         [0027]      FIGS. 6A-6B  illustrate the addition of cutouts in each appliance to indicate an order.  
         [0028]      FIGS. 7A-7C  illustrate a change in color to indicate an order.  
         [0029]      FIG. 8  illustrate an embodiment of a method of delivering appliances in a desired order.  
         [0030]      FIG. 9  illustrates an appliance which includes a readable element embedded in the appliance.  
         [0031]      FIG. 10  illustrates a series of packages  12 , each having a label which includes at least one non-numeric indicia.  
         [0032]      FIG. 11  illustrates a package of dental appliances of the present invention. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0033]     It may be appreciated that the orthodontic appliances may be dispensed to the patient in its entirety, in groups or individually. Providing the patient with the entire series at the outset of treatment may be desirable if the treatment plan is relatively short, the patient is particularly compliant, or it is particularly convenient, to name a few. In this case, the series should be ordered so that the patient can easily selected the next appliance in the sequence when needed. Such ordering may be designated through packaging or the appliance itself. In some situations, the patient may receive additional appliances during the treatment protocol for inclusion in the sequence and/or the patient may receive instructions to eliminate some of the original appliances from the treatment protocol. Therefore, such ordering should allow easy incorporation of additional appliances or deletion of appliances.  
         [0034]     Alternatively, the patient may be provided with a subset of the entire series, such as the first ten appliances. In this case, the subset should be ordered so that the patient can easily selected the next appliance in the sequence when needed. Again, such ordering may be designated through packaging or the appliance itself. The patient may receive additional appliances during the use of the subset for inclusion in the sequence and/or the patient may receive instructions to eliminate some of the original appliances from the subset. Alternatively, the next subset of appliances may differ from that which was initial determined at the outset of the treatment protocol. Therefore, such ordering should allow easy incorporation of additional appliances or deletion of appliances within or between subsets.  
         [0035]     Further, the patient may be provided with individual appliances in the order in which they should be used. In this case, the appliances should be ordered so that the patient can easily differentiate the appliance they are receiving from the appliances already received. Again, such ordering may be designated through packaging or the appliance itself. In addition, such ordering should allow the appliances to be stored and distributed to the patient in the correct sequence with minimal attention from the orthodontic practitioner.  
         [0036]     A variety of embodiments of ordering systems and methods will be described. In a first embodiment, a series of appliances are dispensed to the patient in a continuous chain, wherein the appliances are to be used in the sequence of the chain. An example of such a chain is schematically illustrated in  FIG. 1 . Here, each appliance  10  is disposed within a package  12 , wherein the packages  12  are joined together in a continuous chain. In this embodiment, each package  12  is separable at a perforation  14  from the remaining packages  12  in the chain. It may be appreciated that the packages may be joined and/or are separable in any suitable manner including with the use of adhesives, heat sealing, ultrasonic welding, linkages or simply indications where to cut, break or separate, to name a few. To indicate the end of the chain in which it begin use, a marking may be located on the package  12  or on the appliance  10 . For example, a colored marking  16  may be located on an end package  12   a , as shown. This would indicate that a first appliance  10   a  is enclosed. Once the first appliance  10   a  has been removed from the package  12   a  and worn for a given amount of time, the patient may then open a next package  12   b  in the chain and remove a second appliance  10   b  for wearing. This may be repeated throughout the chain.  
         [0037]     In another embodiment, illustrated in  FIG. 2 , a series of appliances  10  are disposed on a framework  20 , such as a sprue. Sprues typically secure objects, such as molded objects, before their first use. The appliances  10  are secured to the framework  20  in any suitable manner. The appliances  10  are then removed from the framework  20  according to a the treatment protocol. For example, the first appliance  10   a  to be used may be disposed at one end of the framework  20 , the second appliance  10   b  disposed next to the first appliance  10   a , the sequence continuing along the framework  20 . Alternatively or in addition, markings may be disposed on the framework  20  or the appliances  10  themselves indicating an ordering of use.  
         [0038]     In another embodiment, illustrated in  FIG. 3 , a series of appliances  10  are provided to a patient in a dispenser  30 . The dispenser  30  dispenses the appliances  10  in the order to be used. Each appliance  10  may be individually dispensed, as shown, or each appliance  10  may be contained in a package wherein the packages are individually dispensed. The dispenser  30  may include an actuator  32 , such as a lever, button, switch, etc, so that actuation of the actuator  32  dispenses the appliance  10  or package containing the appliance  10 . Alternatively, removal of an appliance  10  from the dispenser  30  may actuate dispensing of the next appliance  10 . In this way, the patient is systematically dispensed appliances in a predetermined order of use.  
         [0039]     In some situations it may be desired to specifically mark the appliances themselves. Such markings ensure that ordering of the appliances is distinguishable after removal of the appliances from any packaging and during use. For example, a portion of each appliance may be changed to indicate a sequence or order.  FIGS. 4A-4B  illustrate a change in length of the appliance  10  by changing the length of a terminal tooth cavity  40 . A terminal tooth cavity  40  is one of the last teeth in the appliance.  FIG. 4A  illustrates a first appliance  10   a  wherein a marked terminal tooth cavity  40   a  has a given length.  FIG. 4B  illustrates a second appliance  10   b  wherein a marked terminal tooth cavity  40   b  has a length which differs from the first appliance  10   a . Here, the marked terminal tooth cavity  40   b  has a shorter length. The lengths can continue to differ throughout the sequence of appliances. Alternatively or in addition, the lengths of other terminal teeth may differ.  
         [0040]      FIGS. 5A-5B  illustrate a change in the height of each appliance  10  to indicate a sequence or order. The height of the appliance  10  is the distance from the occlusal surfaces  46  to the edges  48  of the appliance  10 .  FIG. 5A  illustrates a first appliance  10   a  having a given height.  FIG. 5B  illustrates a second appliance  10   b  having a height which differs from the first appliance  10   a . Here, the second appliance  10   b  has a shorter height. The heights can continue to differ throughout the sequence of appliances indicating an order. It may be appreciate that the overall height of the appliance may differ or the height of specific portions of the appliance may differ through the sequence.  
         [0041]      FIGS. 6A-6B  illustrate the addition of notches or cutouts  56  in each appliance  10  to indicate a sequence or order. The cut outs may be of any size, shape, orientation, or number forming any pattern. Further, the cut outs may be located on an edge  48  of the appliance  10  or on any surface, including an occlusal surface  46 .  FIG. 6A  illustrates a first appliance  10   a  having a first cut out  56   a . The first cut out  56   a  has a rectangular shape and is located near an edge  48 .  FIG. 5B  illustrates a second appliance  10   b  having a second cut out  56   b  so that the cut out pattern of the first appliance  10   a  differs from that of the second appliance  10   b . Here, the second cut out  56   b  also has a rectangular shape and is located near the edge  48  adjacent to the first cut out  56   a . The cut out patterns can continue to differ throughout the sequence of appliances indicating an order.  
         [0042]      FIGS. 7A-7C  illustrate a change in color, such as a hue, gradation of hues, shade, tint or intensity, for each appliance  10  to indicate a sequence or order. For example, the appliances  10  may appear darker or lighter in color through the series, such as ranging from dark red to light pink or vice versa. Or, the sequence may follow the color of the rainbow, such as red, orange, yellow, green, etc. Or, the sequence may follow any other prescribed order of colors.  FIG. 7A  illustrates a first appliance  10   a  having a first color  60   a .  FIG. 7B  illustrates a second appliance  10   b  having a second color  60   b  so that the color of the first appliance  10   a  differs from that of the second appliance  10   b . The color changes can continue to differ throughout the sequence of appliances indicating an order. It may be appreciated that the appliances  10   a ,  10   b  may have the color over their entirety, as shown, or the appliances may be colored in some areas and not in others. Or multiple colors may be used on a single appliance, such as in stripes, blocks or various shapes. The color may be embedded in the appliance, such as with the use of a colored plastic rather than the typical clear plastic. Or, the color may be in the form of a dissolvable dye which dissolves in contact with air, such as upon removal from a package, or contact with liquid, such as when rinsed with water or placed in the patient&#39;s mouth. Alternatively, as illustrated in  FIG. 7C , the color may be present in a peel-away wrapper  62 . The colored wrapper  62  may be attached to the appliance  10  by lamination or other methods. In this example, the wrapper  62  covers the occlusal surfaces  46  of the appliance  10 , however any portion of the appliance  10  may be covered. When the appliance  10  is to be used, the wrapper  62  is peeled away, as shown, and removed. In this way, the appliances may be ordered by color but worn in a transparent state.  
         [0043]     Alternatively or in addition, the patient may be provided with individual appliances in the order in which they should be used. To provide such ordering while allowing the appliances to be stored and distributed to the patient in the correct sequence with minimal attention from the orthodontic practitioner, a method may be used in which the appliances are delivered by mail in a specific sequence.  FIG. 8  illustrates an embodiment of such a method. As shown, the appliances  10  are individually packaged so that a first package  80  contains a first appliance, a second package  82  contains a second appliance, a third package  84  contains a third appliance, etc. The packages  80 ,  82 ,  84  are sent through the mail or any delivery system so that they are delivered to the patient P according to a desired schedule. For example, the first package  80  is delivered to the patient P at day 1, the second package  82  is delivered at day 7, the third package  84  is delivered at day 14, etc. It may be appreciated that the individual packages may alternatively be comprises of series of appliances, such as subsets of the entire series of the treatment plan. In such a case, the patient P is delivered a package of appliances  10  at each interval, wherein each package includes a series of appliances. The series may itself also be ordered by any given system, including any of those mentioned above.  
         [0044]      FIG. 9  illustrates one appliance  10  of a series of appliances wherein the appliance  10  includes a readable element  100  embedded in the appliance  10 . Alternatively, the readable element  100  may be affixed to the appliance  10  or to a package enclosing the appliance. The readable element  100  may comprise a chip, a bar code or other element that is computer readable, including identification by wireless means, including radiofrequency (rf) identification. When a reader  102  passes over the element  100 , the reader  102  translates the information into a word, symbol or other identifying feature. When translated into a word, the word may include, “first”, “second”, “third”, or “last” to name a few. Also, the word may be in any language, including English, Spanish, French, German, Japanese, etc. The word or identifying feature may be auditory, such as a recording or generation of a spoken voice, or visual, such as a print display. Alternatively, the feature may be transmitted by tactile means, such as by vibration.  
         [0045]      FIG. 10  illustrates a series of packages  12 , each package  12  including at least one appliance  10 . Affixed to or incorporated in each package  12  is a label  100 . The label  100  includes at least one non-numeric indicia. For example, a first package  102  shows a label  100  having a series of numbers wherein one number is marked, in this case stamped with a colored dot  103 . This indicates which appliance  10  the first package  102  contains in the treatment sequence. It may be appreciated that the number can be marked with any symbol by any method, including removing the number by erasure, punch-out or notching. It may also be appreciated that other symbols may be used other than numbers, wherein one of the symbols is marked. This is illustrated in a second package  104  which shows such a label  100 . A third package  106  shows a label  100  having a series of symbols, such as shapes, in this case, trianglesl 20 . The symbols themselves or the color, number, or arrangement may indicate which appliance  10  the third package  106  contains in the treatment series. It may be appreciated that such symbols may include stripes, as illustrated on a fourth package  108  which shows such a label  100 . The stripes may be human readable or computer readable, such as a barcode.  
         [0046]      FIG. 11  illustrates an embodiment of a package of dental appliances comprising a package  12  including a plurality of dental appliances  10  positioned in an arrangement within the package  12  which indicates an order of usage. In this embodiment, the arrangement comprises stacking of the appliances.  
         [0047]     Although the foregoing invention has been described in some detail by way of illustration and example, for purposes of clarity of understanding, it will be obvious that various alternatives, modifications and equivalents may be used and the above description should not be taken as limiting in scope of the invention which is defined by the appended claims.