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Publication numberWO2006084079 A2
Publication typeApplication
Application numberPCT/US2006/003753
Publication date10 Aug 2006
Filing date2 Feb 2006
Priority date3 Feb 2005
Also published asWO2006084079A3
Publication numberPCT/2006/3753, PCT/US/2006/003753, PCT/US/2006/03753, PCT/US/6/003753, PCT/US/6/03753, PCT/US2006/003753, PCT/US2006/03753, PCT/US2006003753, PCT/US200603753, PCT/US6/003753, PCT/US6/03753, PCT/US6003753, PCT/US603753, WO 2006/084079 A2, WO 2006084079 A2, WO 2006084079A2, WO-A2-2006084079, WO2006/084079A2, WO2006084079 A2, WO2006084079A2
InventorsHuafeng Wen, Mari Sawtelle, Keith R. Wolf
ApplicantAlign Technology, Inc.
Export CitationBiBTeX, EndNote, RefMan
External Links: Patentscope, Espacenet
Organizing, storing, and tracking dental devices
WO 2006084079 A2
Abstract
Systems, methods, and apparatuses are disclosed for manufacturing, organizing, storing, and tracking dental devices such as removable dental aligners. In some variations, these systems, methods, and apparatuses may enable a patient or doctor to select the proper dental device from a series of dental devices to be worn in an intended sequence even where the dental devices are unmarked with respect to their position in the sequence. For example, the dental devices may be arranged in a manner that leads the patient or doctor to intuitively select and use the dental aligners in the appropriate sequence. This can be accomplished, for example, by presenting the dental devices in the sequence in which they are to be worn or presenting them in a manner that encourages or requires accessing them in that sequence.
Claims  (OCR text may contain errors)
Whafis claihWlS:
1. A method for providing an orthodontic treatment to a patient, the method comprising: providing a plurality of dental aligners to be worn in a particular sequence by the patient to move the patient's teeth according to an orthodontic treatment plan; and arranging the plurality of dental aligners such that each dental aligner is accessible only if the dental aligners in the plurality prior to it in the particular sequence have been accessed.
2. The method of claim 1 , further comprising providing the plurality of dental aligners directly to the patient.
3. The method of claim 1, further comprising providing a structure including the dental aligners, wherein the structure is configured such that each dentar aligner is accessible only if the dental aligners in the plurality prior to it in the particular sequence have been accessed.
4. The method of claim 3, wherein accessing a dental aligner comprises removing it from the structure.
5. The method of claim 3, wherein providing a structure comprises: providing a structure including a plurality of chambers corresponding to different positions in the particular sequence in which the plurality of dental aligners are to be worn, each chamber comprising one or more dental aligners; wherein the structure is configured such that each chamber can be opened only if the chambers corresponding to prior positions in the particular sequence have been opened.
6. The method of claim 5, wherein accessing a dental aligner comprises opening a chamber comprising the dental aligner.
7. The method of claim 3, further comprising fabricating the structure to comprise frangible connectors connecting the dental aligners in the particular sequence in which they are to be worn.
8. The method of claim 7, wherein accessing a dental aligner comprises disconnecting it from the structure.
9. The method of claim 3, wherein providing a structure comprises: providing a structure comprising a plurality of bags removably attached to a support and corresponding to different positions in the particular sequence, each bag comprising at least one dental aligner; wherein each B'ag'niay'be" opened only if the bags corresponding to prior positions in the particular sequence have been removed.
10. The method of claim 3, further comprising providing the structure directly to the patient.
11. The method of claim 1 , further comprising providing a container including the plurality of dental aligners; wherein the container is configured such that each dental aligner is accessible only if the dental aligners in the plurality prior to it in the particular sequence have been accessed.
12. The method of claim 11 , further comprising stacking the plurality of dental aligners in the container in the particular sequence in which they are to be worn.
13. The method of claim 11, wherein accessing a dental aligner comprises removing it from the container.
14. The method of claim 11, wherein accessing_ a dental aligner comprises activating a dispensing mechanism that dispenses an aligner from the container.
15. The method of claim 11 , further comprising providing the container directly to the patient.
16. A structure for storing dental aligners comprising: a plurality of dental aligners to be worn in a particular sequence by a patient to move the patient's teeth according to an orthodontic treatment plan; wherein the structure is configured such that each dental aligner is, accessible only if the dental aligners in the plurality prior to it in the particular sequence have been accessed.
17. ' The structure of claim 16, wherein accessing a dental aligner comprises removing it from the structure.
18. The structure of claim 16, wherein accessing a dental aligner comprises opening a chamber comprising the accessed dental aligner.
19. The structure of claim 16, further comprising: a plurality of chambers corresponding to different positions in the particular sequence, each comprising one or more dental aligners, wherein the structure is configured such that each chamber can be opened only if the chambers corresponding to prior positions in the particular sequence have been opened. . The strac u e a rt er comp s ng: a plurality of bags removably attached to a support and corresponding to different positions in the particular sequence, each chamber comprising at least one dental aligner; wherein each bag may be opened only if the bags corresponding to prior positions in the particular sequence have been removed.
21. The structure of claim 16, further comprising a container including the plurality of dental aligners.
22. The structure of claim 21 , wherein the plurality of dental aligners are stacked in the container in the particular sequence in which they are to be worn.
23. The structure of claim 21, further comprising a dispensing mechanism that dispenses the dental aligners in the particular sequence in which they are to be worn.
24. The structure of claim 23, wherein the dental aligners are dispensed in a first-in-first-out order.
25. The structure of claim 23, wherein the dental aligners are dispensed in a fϊrst-in-last-out order.
26. The structure of claim 16, further comprising frangible connectors connecting the dental aligners, wherein accessing a dental aligner comprises disconnecting it from the structure.
27. The structure of claim 16, further comprising: a cylindrical body having a closed bottom end and an open top end; a lower chamber defined by the closed end and a removable partition positioned between the open and closed ends, the lower chamber comprising at least one dental aligner; and an upper chamber defined by the removable partition and a removable lid covering the open end, the upper chamber comprising at least one dental aligner; wherein the dental aligner or aligners in the upper chamber are to be worn prior to the dental aligner or aligners in the lower chamber.
28. A system for tracking use of a dental device by a patient, the system comprising at least one sensor to detect use of the dental device by the patient.
29. The system of claim 28, wherein the sensor comprises one or more of a timer, a weight sensor, a pressure sensor, an optical sensor, a moisture sensor, a chemical sensor, an RFID sensor, a color sensor, a blood sugar sensor, a pulse sensor, or a temperature sensor. 30. lΕe system of cliiήi 2&;'"ϊurther comprising a timer configurable to alert the patient to begin use of the dental device.
31. The system of claim 28, further comprising at least one recorder to record data collected by the sensor.
32. The system of claim 31, wherein the recorder records times at which use of the dental device by the patient begins and ends.
33. The system of claim 28, further comprising a container for the dental device, wherein the container includes the sensor.
34. The system of claim 33, wherein the sensor detects whether the dental device is present in the container.
35. The system of claim 33, wherein the sensor detects when the container is opened or closed.
36. The system of claim 33, further comprising a recorder that records data collected by the sensor. >
37. The system of claim 36, wherein the recorder records times at which the dental device is removed from and returned to the container.
38. The system of claim 28, wherein the sensor is attached to the dental device.
39. The system of claim 31, wherein the data is downloadable.
40. The system of claim 28, wherein the dental device is one of a dental aligner, a dental retainer, and a denture.
41. A system for organizing dental aligners for a subject, comprising: a plurality of dental aligners configured to move the subject's teeth at different steps of an orthodontic treatment; and one or more frangible connectors configured to connect the plurality of dental aligners so that the dental aligners can be disconnected in the sequence that the dental aligners are to be used at the different steps of the orthodontic treatment.
42. The system of claim 41, wherein at least one of the dental aligners comprises '1.,,I' J....I!Jk.,U I|,,,ll Λ 11..11,,,,,JI jL1 H ,.,,,If c 1 • ~ , • .1 _• • a shell portion having an outer surface, and an inner surface wherein the inner surface is configured to contact a subject's tooth; a bottom portion configured to be placed near the gingiva of the subject's tooth; and a tip portion on the opposite side of the dental aligner from the bottom portion.
43. The system of claim 42, wherein the shell portion comprises a fluid-permeable material that allows fluid to communicate between a subject's tooth and at least a portion of the outer surface.
44. The system of claim 42, wherein the dental aligner comprises one or more wrinkled surfaces over at least a region of the shell portion, the bottom portion or the tip portion.
45. The system of claim 41 , wherein the plurality of dental aligners comprise one or more of: a polymeric material, a plastic, a urethane, an epoxy, a plaster, a stone, a clay, an acrylic, a metal, a wood, a paper, a ceramic, and a porcelain.
46. The system of claim 41 , wherein the plurality of dental aligners are fabricated by vacuum forming using a plurality of dental arch models that correspond to configurations at different steps of the orthodontic treatment.
47. The system of claim 41, wherein the plurality of dental aligners is fabricated by molding or CNC based manufacturing.
48. The system of claim 41, wherein the plurality of dental aligners are configured to be connected by the connectors to form a one-dimensional array or a two-dimensional array.
49. The system of claim 41, further comprising markings to indicate the sequence that the dental aligners are to be used.
50. A method for organizing dental aligners for a subject, comprising: determining a particular sequence that a plurality of dental aligners will be used by the subject in an orthodontic treatment, wherein the dental aligners are configured to move the subject's teeth in a plurality of steps during the orthodontic treatment; and fabricating a connected array of dental aligners, wherein the dental aligners are disposed in the connected array so that they are removable from the connected array in the same sequence as the sequence to be used by the subject in the orthodontic treatment.
51. The method of claim 50, wherein the connected array comprises a one-dimensional array of the dental aligners or a two-dimensional array of the dental aligners. 52. " The nϊetriod of claim'SOr wherein fabricating the connected array of dental aligners comprises: fabricating the dental aligners; and connecting the dental aligners in a connected array.
53. The method of claim 50, further comprising marking the connected array to indicate treatment order.
54. The method of claim 50, wherein fabricating the connected array of dental aligners comprises: fabricating the dental aligners in a sheet of an aligner-making material; and cutting the sheet of the aligner-making material having the fabricated dental aligners to produce the connected array of dental aligners.
55. The method of claim 50, further comprising: fabricating the connected array of dental aligners using a plurality of dental arch models that correspond to configurations at different steps of the orthodontic treatment.
56. The method of claim 55, further comprising: vacuum forming the connected array of dental aligners to from a sheet of aligner-making material using a plurality of dental arch models that correspond to configurations at different steps of the orthodontic treatment.
57. A method for organizing dental aligners for a subject, comprising: determining the sequence for a plurality of dental aligners to be used by the subject in an orthodontic treatment, wherein the dental aligners are configured to be applied in a plurality of steps in the orthodontic treatment to move the subject's teeth; and vacuum forming a connected array of dental aligners using a plurality of dental arch models that correspond to configurations of the dental aligners at different steps of the orthodontic treatment.
58. The method of claim 57, wherein the step of vacuum forming the connected array of dental aligners comprises: fabricating the dental aligners in a sheet of an aligner-making material using the plurality of dental arch models; and cutting the sheet of the aligner-making material having the fabricated dental aligners to produce a connected array of dental aligners. 5"9. " TheHeth'od δfcϊaim"'57T wherein the dental aligners are disposed in the array in the same sequence as the sequence that the plurality of dental aligners is to be used by the subject.
60. The method of claim 58, wherein the dental aligners are disposed in a one-dimensional array or a two-dimensional array.
61. A container for storing dental devices, comprising: a container body adapted to hold the dental devices; and a dispensing mechanism configured to dispense one of the dental devices when the dispensing mechanism is triggered.
62. The container of claim 61, wherein the dispensing mechanism comprises a spring mechanism that is configured to dispense one of the dental devices stored in the container.
63. The container of claim 61 , wherein the dispensing mechanism is triggered by the pressing of a release button.
64. The container of claim 61 , wherein the dispensing mechanism includes a window configured to allow the dispensing of the dental device.
65. The container of claim 61, wherein the dental devices are stored in a fixed order in the container.
66. The container of claim 61, wherein the dental devices stored in the container are dispensed by the dispensing mechanism in a first-in and first-out order.
67. The container of claim 61, wherein the container body can hold three or more dental devices.
68. The container of claim 61, further comprising a container cap that can be locked to the container body and seal the dental devices inside the container body.
69. The container of claim 61, further comprising a slide-able door on one side of the container body.
70. The container of claim 69, wherein the slide-able door is capable of cutting off a portion of the packaging material for a dental device stored in the container body. 71. The container "ofclaim 61 , wherein the dental devices stored in the container body include one or more of dental aligners, dental brackets, dental arch models, tooth models, and bases or base components for tooth models.
72. A container for storing dental devices, comprising: a container body adapted to hold the dental devices; a dispensing mechanism configured to dispense one of the dental devices when the dispensing mechanism is triggered; and a window configured to allow the dispensing of the dental device.
73. The container ofclaim 72, wherein the dispensing mechanism comprises a spring mechanism that is configured to dispense one of the dental devices stored in the container when the dispensing mechanism is triggered by the pressing of a release button.
74. The container ofclaim 72, wherein the dental devices stored in the container are dispensed by the dispensing mechanism in a first-in and first-out order.
75. The container ofclaim 72, further comprising a container cap that can be locked to the container body and seal the dental devices inside the container body.
76. The container ofclaim 72, further comprising a slide-able door on one side of the container body.
77. The container of claim 76, wherein the slide-able door is capable of cutting off a portion of the packaging material for a dental device stored in the container body.
78. The container of claim 72, wherein the dental devices stored in the container body include one or more of dental aligners, dental brackets, dental arch models, tooth models, and bases or base components for tooth models.
79. A container for storing dental devices, comprising: a container body adapted to hold the dental devices; a window configured to allow the dispensing of the dental device; a spring enabled dispensing mechanism configured to dispense one of the dental devices stored in the container in a first-in and first-out order when the spring enabled dispensing mechanism is triggered by the pressing of a release button. 80. The 'container or claim 79, wherein the dental devices stored in the container body include one or more of dental aligners, dental brackets, dental arch models, tooth models, and bases or base components for tooth models.
81. A system for tracking a dental device, comprising: a label storing information about a patient's dental treatment, wherein the label is configured to be attached to the dental device; and a detector configured to extract data from the label to determine the shipping destination of the dental device.
82. The system of claim 81, wherein the information comprises one or more of information about the doctor conducting the dental treatment, the job information for dental treatment, information about the batch of dental devices for a plurality of patients, manufacture information, and treatment schedules.
83. The system of claim 81, wherein the label includes barcodes or RFID tags.
84. The system of claim 81, wherein the label includes one or more of inductively coupled RFID tags and capacitively coupled RFID tags.
85. The system of claim 81, wherein the label is embedded inside a dental device or a package containing one or more dental device.
86. The system of claim 81, wherein the dental devices include one or more of dental aligners, dental brackets, dental arch models, tooth models, and bases or base components for tooth models.
87. The system of claim 81 , further comprising a computer that is configured to interpret the data extracted from the label to determine the shipping destination of the dental device.
88. The system of claim 81 wherein storing information comprises encoding the information.
89. The system of claim 81 wherein storing information comprises encoding a pointer to the information.
90. A system for tracking a dental device, comprising: a label storing information about a patient's dental treatment, wherein the label is configured to be attached to the dental device; a "deϊectό'r coήfigύfed'tb" extract data from the label to determine the shipping destination of the dental device; and a computer that is configured to interpret the data extracted from the label to determine the shipping destination of the dental device.
91. The system of claim 90, wherein the information comprises one or more of information about the doctor conducting the dental treatment, the job information for dental treatment, information about the batch of dental devices for a plurality of patients, manufacture information, and treatment schedules.
92. The system of claim 90, wherein the label includes barcodes or RPID tags.
93. The system of claim 90, wherein the label includes one or more of inductively coupled RFID tags and capacitively coupled RFID tags.
94. The system of claim 90, wherein the label is embedded inside a dental device or a package containing one or more dental devices.
95. The system of claim 90, wherein the dental devices include one or more of dental aligners, dental brackets, dental arch models, tooth models, and bases or base components for tooth models.
96. The system of claim 90, further comprising a computer that is configured to interpret the data extracted from the label to determine the shipping destination of the dental device.
97. The system of claim 90 wherein storing information comprises encoding the information.
98. The system of claim 90 wherein storing information comprises encoding a pointer to the information.
99. A method for tracking dental devices, comprising: creating a data structure comprising information about a patient's dental treatment; storing the data structure in a label; attaching the label to a dental device; and extracting data from the data structure stored in the label to determine the shipping destination of the dental device.
100. The method of claim 99, wherein the data structure comprises one or more of information about the doctor conducting the dental treatment, the job information for dental treatment, devices for a plurality of patients, manufacture information, and treatment schedules.
101. The method of claim 99, wherein the label includes one or more of a barcode, an RFID tag, an inductively coupled RFID tag, and a capacitively coupled RFID tag.
102. The method of claim 99, wherein the label is embedded inside a dental device or a package containing one or more dental devices.
103. The method of claim 99, wherein the dental devices include one or more of dental aligners, dental brackets, dental arch models, tooth models, and bases or base components for tooth models.
104. The method of claim 99, further comprising fabricating the dental component in accordance with the information in the data structure stored in the label.
105. The system of claim 99 wherein storing information comprises encoding the information.
106. The system of claim 99 wherein storing information comprises encoding a pointer to the information.
Description  (OCR text may contain errors)

ORGANIZING, STORING, AND TRACKING DENTAL DEVICES

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] This application is a continuation-in-part of U.S. Patent Application No. 11/205,496, titled "SYSTEM FOR ORGANIZING DENTAL ALIGNERS," filed August 16, 2005, U.S. Patent Application No. 11/050,051, titled "STORAGE SYSTEMS FOR DENTAL DEVICES," filed February 3, 2005, and U.S. Patent Application No. 11/050,050, titled "INTELLIGENT TRACKING OF DENTAL DEVICES," filed February 3, 2005, each of which is incorporated by reference herein in its entirety for all purposes.

[0003] The present invention is also related to U.S. Provisional Patent Application No. 60/675,003, filed April 25, 2005, U.S. Provisional Patent Application No. 60/676,278, filed April 29, 2005, U.S. Provisional Patent Application No. 60/676,100, filed April 29, 2005, U.S. Patent Application No. 11/107,584, titled "DIGITAL ALIGNER DEVICES HAVING SNAP-ON FEATURES," filed April 15, 2005, U.S. Patent Application No. 11/074,297, titled "PRODUCING WRINKLED DENTAL ALIGNER FOR DENTAL TREATMENT," filed March 7, 2005, U.S. Patent Application No. 11/074,300, titled "FLUID PERMEABLE DENTAL ALIGNER," filed 3/7/2005, U.S. Patent Application No. 11/074,298, titled "DISPOSABLE DENTAL ALIGNER," filed 3/7/2005, and International Patent Application No. PCT/US2005/039715, titled "METHODS AND APPARATUSES FOR MANUFACTURING DENTAL ALIGNERS," filed November 2, 2005, each of which is incorporated herein by reference in its entirety for all purposes.

BACKGROUND

[0004] Orthodontics is the practice of manipulating a patient's teeth to provide better function and appearance. Typically, brackets are bonded to a patient'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 and are held in a place for a certain period of time, the body adapts bone and the surrounding soft-tissue to maintain the teeth in the desired location. To further assist in retaining the teeth in the desired location, a patient may be fitted with a retainer. [0005] Tb achieve tooth' movement, orthodontists utilize their expertise to first determine a three-dimensional mental image of the patient's physical orthodontic structure and a three- dimensional mental image of a desired physical orthodontic structure for the patient, 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, plans next steps in the treatment (e.g., determines new bends in the wire, repositions or replaces brackets, decides whether a head gear is required, etc.), and evaluates the success of the previous steps.

[0006] 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 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 hard 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 process success and speed being very much dependent on the orthodontist's motor skills and diagnostic expertise. As a result of multiple wire changes, patient discomfort is increased as well as the cost. As one would expect, the quality of care varies greatly from orthodontist to orthodontist as does the amount of time required to treat a patient.

[0007] Over the years, various methods and devices have been developed to assist dentists with delivery of orthodontic treatments. Examples of these methods and devices are disclosed in U.S. Patent No. 6,699,037 B2 titled "METHOD AND SYSTEM FOR INCREMENTALLY MOVING TEETH" issued to Chishti et al., dated March 2, 2004; U.S. Patent No. 6,682,346 B2 titled "DEFINING TOOTH-MOVING APPLIANCES COMPUTATIONALLY" issued to Chishti et al., dated January 27, 2004; U.S. Patent No. 6,471,511 titled "DEFINING TOOTH- MOVING APPLIANCES COMPUTATIONALLY" issued to Chishti et al., dated October 29, 2002; U.S. Patent No. 5,645,421 titled "ORTHODONTIC APPLIANCE DEBONDER" issued to Slootsky, dated July 8, 1997; U.S. Patent No. 5,618,176 titled "ORTHODONTIC BRACKET AND LIGATURE AND METHOD OF LIGATING ARCHWIRE TO BRACKET" issued to Andreiko et al, aaWApril';8';T997; U.S. Patent No. 5,607,305 titled "PROCESS AND DEVICE FOR PRODUCTION OF THREE-DIMENSIONAL DENTAL BODIES" issued to Andersson et al., dated March 4, 1997; U.S. Patent No. 5,605,459 titled "METHOD OF AND APPARATUS FOR MAKING A DENTAL SET-UP MODEL" issued to Kuroda et al., dated February 25, 1997; U.S. Patent No. 5,587,912 titled "COMPUTER AIDED PROCESSING OF THREE- DIMENSIONAL OBJECT AND APPARATUS THEREFOR" issued to Andersson et al., dated December 24, 1996; U.S. Patent No. 5,549,476 titled "METHOD FOR MAKING DENTAL RESTORATIONS AND THE DENTAL RESTORATION MADE THEREBY" issued to Stern, dated August 27, 1996; U.S. Patent No. 5,533,895 titled "ORTHODONTIC APPLIANCE AND GROUP STANDARDIZED BRACKETS THEREFOR AND METHODS OF MAKING, ASSEMBLING AND USING APPLIANCE TO STRAIGHTEN TEETH" issued to Andreiko et al., dated July 9, 1996; U.S. Patent No. 5,518,397 titled "METHOD OF FORMING AN ORTHODONTIC BRACE" issued to Andreiko et al., dated May 21, 1996; U.S. Patent No. 5,474,448 titled "LOW PROFILE ORTHODONTIC APPLIANCE" issued to Andreiko et al., dated December 12, 1995; U.S. Patent No. 5,454,717 titled "CUSTOM ORTHODONTIC BRACKETS AND BRACKET FORMING METHOD AND APPARATUS" issued to Andreiko et al., dated October 3, 1995; U.S. Patent No. 5,452,219 titled "METHOD OF MAKING A TOOTH MOLD" issued to Dehoff et al., dated September 19, 1995; U.S. Patent No. 5,447,432 titled "CUSTOM ORTHODONTIC ARCHWIRE FORMING METHOD AND APPARATUS" issued to Andreiko et al., dated September 5, 1995; U.S. Patent No. 5,431,562 titled "METHOD AND APPARATUS FOR DESIGNING AND FORMING A CUSTOM ORTHODONTIC APPLIANCE AND FOR STRAIGHTENING OF TEETH THEREWITH" issued to Andreiko et al., dated July 11, 1995; U.S. Patent No. 5,395,238 titled "METHOD OF FORMING ORTHODONTIC BRACE" issued to Andreiko et al., dated March 7, 1995; U.S. Patent No. 5,382,164 titled "METHOD FOR MAKING DENTAL RESTORATIONS AND THE DENTAL RESTORATIONS MADE THEREBY" issued to Stern, dated January 17, 1995; U.S. Patent No. 5,368,478 titled "METHOD FOR FORMING JIGS FOR CUSTOM PLACEMENT OF ORTHODONTIC APPLIANCES ON TEETH" issued to Andreiko et al, dated November 29, 1994; U.S. Patent No. 5,342,202 titled "METHOD FOR MODELING CRANIO-FACIAL ARCHITECTURE" issued to Deshayes, dated August 30, 1994; U.S. Patent No. 5,340,309 titled "APPARATUS AND METHOD FOR RECORDING JAW MOTION" issued to Robertson, dated August 23, 1994; U.S. Patent No. 5,338,198 titled "DENTAL MODELING SIMULATOR" issued to Wu et al., dated August 16, 1994; U.S. Patent No. 5,273,429 titled "METHOD AND APPARATUS FOR MODELING A DENTAL PROSTHESIS" issued to Rekow et al., dated December 28, 1993; U.S. Patent No. 5,186,623 titled "ORTHODONTIC FINISHING P1USITIONER1AM) METHOD OF CONSTRUCTION" issued to Breads et al., dated February 16, 1993; U.S. Patent No. 5,139,419 titled "METHOD OF FORMING AN ORTHODONTIC BRACE" issued to Andreiko et al., dated August 18, 1992; U.S. Patent No. 5,059,118 titled "ORTHODONTIC FINISHING POSITIONER AND METHOD OF CONSTRUCTION" issued to Breads et al., dated October 22, 1991; U.S. Patent No. 5,055,039 titled "ORTHODONTIC POSITIONER AND METHODS OF MAKING AND USING SAME" issued to Abbatte et al., dated October 8, 1991; U.S. Patent No. 5,035,613 titled "ORTHODONTIC FINISHING POSITIONER AND METHOD OF CONSTRUCTION" issued to Breads et al., dated July 30, 1991; U.S. Patent No. 5,011,405 titled "METHOD FOR DETERMINING ORTHODONTIC BRACKET PLACEMENT" issued to Lemchen, dated April 30, 1991; U.S. Patent No. 4,936,862 titled "METHOD OF DESIGNING AND MANUFACTURING A HUMAN JOINT PROSTHESIS" issued to Walker et al., date June 26, 1990; U.S. Patent No. 4,856,991 titled "ORTHODONTIC FINISHING POSITIONER AND METHOD OF CONSTRUCTION" issued to Breades et al., dated August 15, 1989; U.S. Patent No. 4,798,534 titled "METHOD OF MAKING A DENTAL APPLIANCE" issued to Breads, dated January 17, 1989; U.S. Patent No. 4,755,139 titled "ORTHODONTIC ANCHOR APPLIANCE AND METHOD FOR TEETH POSITIONING AND METHOD OF CONSTRUCTING THE APPLIANCE" issued to Abbatte et al., dated July 5, 1988; U.S. Patent No. 3,860,803 titled "AUTOMATIC METHOD AND APPARATUS FOR FABRICATING PROGRESSIVE DIES" issued to Levine, dated January 14, 1975; U.S. Patent No. 3,660,900 titled "METHOD AND APPARATUS FOR IMPROVED ORTHODONTIC BRACKET AND ARCH WIRE TECHNIQUE" issued to Andrews, dated may 9, 1972; each of which is incorporated herein by reference in its entirety for all purposes.

[0008] The practice of orthodontics and other dental treatments including preparation of a denture can benefit from a computer model that is representative of the position of the teeth in a tooth arch. The computer model may be prepared based on an impression model taken from the patient. The computer model may be utilized to assist the dentist in planning an orthodontic treatment regimen by providing visual feedback of possible treatment steps in particular treatment regimen.

[0009] In particular, the computer modeling tool may be useful in designing and manufacturing removable aligning appliances for orthodontic treatment. In some existing systems, an impression model of the dentition of the patient is obtained by the orthodontist and shipped to a remote appliance manufacturing center, where information regarding the patient's teeth is captured by a computer. A computer model of the dentition in a target situation is generated at tne'appiiance manufacturing center and made available for viewing to the orthodontist over the Internet. The orthodontist indicates changes he or she wishes to make to individual tooth positions. Later, another virtual model may be provided over the Internet and the orthodontist reviews the revised model, and indicates any further changes. After one or more of such iterations, the target situation is agreed upon. One or more of the removable aligning appliances (e.g., devices, shells, etc) are manufactured and delivered to the orthodontist. When implemented on a patient's teeth, the appliances move the teeth toward the desired or target positions.

[0010] Repositioning is accomplished with 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 treatment steps, although complex cases involving many of the 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. 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.

[0011] The individual appliances include 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, certain 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 sufficient resilient force against such misaligned teeth in order to reposition the teeth to the intermediate or end arrangement desired for that treatment step.

[0012] Removable dental aligners have been fabricated, for example, from molds created using a stereo lithography process.

[0013] A challenge for orthodontic treatment using removable aligning devices is to accurately and effectively organize, store, and track a sequence of dental devices (e.g., upper and/or lower removable dental aligners) u'Secffor the treatment. For example, an entire sequence of aligners may be determined prior to beginning a treatment. Thus, an entire series of aligners may be fabricated at once. It may be difficult to organize, store, track, and present, or dispense the aligners so that a subject for whom the aligners are intended is able to select and wear them in the proper (e.g., the intended) order. Preparing an entire series of aligners at once may ultimately save in cost, treatment time, and may also enhance user comfort. In addition, it may be difficult to track dental devices such as aligners and brackets, for example, through the various steps of design, manufacture, and distribution to doctors and patients.

SUMMARY

[0014] Examples and variations of systems, methods, and apparatuses for manufacturing, organizing, storing, and tracking dental devices such as removable dental aligners, for example, are described herein. In some variations, these systems, methods, and apparatuses may advantageously enable a patient to easily select the proper dental device from a series of dental devices to be worn in an intended sequence even where the dental devices are unmarked with respect to their position in the sequence. For example, the dental devices may be arranged in a manner that leads the patient or doctor to intuitively select and use the dental aligners in the appropriate sequence. This can be accomplished, for example, by presenting the dental devices in the sequence in which they are to be worn, presenting them in a manner that requires that they be accessed in sequence, or presenting them in a manner that makes it difficult to access them out of, sequence. As a consequence, selection and use of the dental aligners may be less prone to error. I

[0015] In one aspect, methods are disclosed for providing an orthodontic treatment to a patient. In some variations these methods include the steps of providing a plurality of dental aligners to be worn in a particular sequence by the patient to move the patient's teeth according to an orthodontic treatment plan, and arranging the plurality of dental aligners such that each dental aligner is accessible to the patient only if the dental aligners in the plurality that are prior to it in the particular sequence have been accessed. These methods may further include providing the plurality of dental aligners directly to the patient rather than, for example, to a dentist or orthodontist who subsequently provides them to the patient.

[0016] Generally, a dental aligner is accessible if the patient can get at it or reach it to use it. A dental aligner has been accessed if the patient has removed barriers to getting at or reaching it or has otherwise gotten at it or reached it. A dental aligner may be inaccessible, for example, Because access to it is (e.g., Temporarily) blocked by another dental aligner and/or by a part of a structure or container in which i;t is included or housed.

[0017] The plurality of dental aligners provided in the disclosed methods may be a subset of a larger number of dental aligners to be worn by the patient in sequence as part of the orthodontic treatment. One or more sets of dental aligners earlier in the sequence may have been previously provided to the patient or doctor, for example. Also, one or more sets of dental aligners later in the sequence may be subsequently provided or provided at the same time. In the disclosed methods, access to dental aligners in one plurality or set of dental aligners need not be affected by whether or not dental aligners in a separately (e.g., previously) provided plurality or set of dental aligners have been accessed.

[0018] The disclosed methods for providing an orthodontic treatment may comprise providing a structure comprising the dental aligners, wherein the structure is configured such that each dental aligner is accessible to the patient only if the dental aligners in the plurality that are prior to it in the sequence have been accessed. Accessing a dental aligner included in a structure may comprise removing it from the structure, hi one variation, the structure comprises a plurality of chambers corresponding to different positions in the particular sequence in which the dental aligners are to be worn. Each chamber comprises one or more dental aligners. The structure is configured such that each chamber can be opened only if the chambers corresponding to prior positions in the particular sequence have been opened. In this variation, accessing a dental aligner may comprise opening a chamber containing the dental aligner. In another variation, the structure comprises a plurality of bags removably attached to a support and corresponding to different positions in the particular sequence. Each bag comprises at least one dental aligner, and may be opened only if the bags corresponding to prior positions in the sequence have been opened and/or removed. Another variation comprises fabricating the structure to comprise frangible connectors connecting the dental aligners in the sequence in which they are to be worn. In this variation, accessing a dental aligner may comprise disconnecting it from the structure.

[0019] The disclosed methods for providing an orthodontic treatment may comprise providing a container comprising the dental aligners, wherein the container is configured such that each dental aligner is accessible to the patient only if the dental aligners in the plurality that are prior to it in the sequence have been accessed. In one variation, the dental aligners are stacked in the container in the sequence in which they are to be worn. Accessing a dental aligner included in a container may comprise removing it from the container. For example, accessing a dental aligner included in a container may comprise activating a dispensing mechanism that dispenses an aligner from the container. The dental aligners may be dispensed or removed in a first-in-first- out (FIFO) order or in a first-in-last-out (FILO) order, for example.

[0020] In another aspect, structures and containers are disclosed having features as described above. In some variations, these structures and containers and the dental aligners they comprise are provided directly to the patient rather than, for example, indirectly through a dentist or orthodontist.

[0021] In another aspect, systems are disclosed for organizing dental aligners for a subject, including a plurality of dental aligners configured to move the subject's teeth at different steps of an orthodontic treatment, and one or more frangible connectors configured to connect the plurality of dental aligners so that the dental aligners can be disconnected from each other in the sequence that the dental aligners are to be used at the different steps of the orthodontic treatment. The frangible connectors may be made σf substantially the same material as the aligners, or they may be a separate material. In general, the frangible connectors are manually breakable; thus the dental aligners may be separated from each other by the subject without requiring any additional tools. In some variations, the frangible connectors are breakable using a tool. A specific tool may be provided.

[0022] The aligners may include a shell portion having an outer surface, and an inner surface wherein the inner surface is configured to contact a subject's tooth, a bottom portion configured to be placed near the gingiva of the subject's tooth, and a tip portion on the side of the dental aligner opposite from the bottom portion. The shell portion may comprise a fluid-permeable material that allows fluid to communicate between a subject's tooth and at least a portion of the outer surface. The dental aligners linked by the connector(s) may have one or more wrinkled surfaces over at least a region of the shell portion, the bottom portion or the tip portion. Furthermore, the dental aligners may be made of any appropriate material, including one or more of: a polymeric material, a plastic, a urethane, an epoxy, a plaster, a stone, a clay, an acrylic, a metal, a wood, a paper, a ceramic, and a porcelain.

[0023] The manner in which the dental aligners are fabricated may determine the arrangement or nature of the connectors. For example, in some variations, the dental aligners are fabricated by vacuum forming using a plurality of dental arch models that correspond to configurations of the dental arch at different steps of the orthodontic treatment. The dental aligners may be fabricated by molding or CNC-based manufacturing. The dental aligners may be configured to connect to form a one-dimensional array or a two-dimensional array. These arrays may be organized in any appropriate way. For example, in some variations, the arrays of aligners are arranged''so'Mτ"ftie ifighers" are" arranged "on top" of each other. For example, the upper region of one aligner (e.g., a tip portion) may be adjacent to the lower region (e.g., bottom portion) of another aligner. In some variations, the aligners are arranged side-by side.

[0024] A system for organizing dental aligners may also include markings to indicate the sequence that the dental aligners are to be used by a subject. For example, the aligner may be marked, the connector may include markings, or an additional label may be included as part of the system. In some variations, the system may include a dispenser for dispensing the aligners in a predetermined sequence. For example, the dispenser may include interconnected chambers that hold individual (or pairs, such as upper and lower pairs of) aligners. In some variations, the dispenser is a container (e.g., a box, tube, etc.) that only permits the sequential release of a single aligner at a time (or the matching upper and lower aligners).

[0025] In another aspect, methods are disclosed for organizing dental aligners for a subject. In some variations, the methods include the steps of determining a sequence that a subject will use the plurality of dental aligners in an orthodontic treatment (wherein the dental aligners are configured to move the subject's teeth in a plurality of steps during the orthodontic treatment) and fabricating a connected array of dental aligners (wherein the dental aligners are disposed in the connected array so that they may be removed from the connected array in the same sequence as the sequence to be used by the subject in the orthodontic treatment). The connected array comprises a one-dimensional array of the dental aligners or a two-dimensional array of the dental aligners.

[0026] A method for organizing dental aligners may include the step of marking the connected array to indicate treatment order. The method may also include the step of fabricating the connected array of dental aligners using a plurality of dental arch models that correspond to configurations at different steps of the orthodontic treatment. In some variations, the method includes the step of vacuum forming the connected array of dental aligners from a sheet of aligner-making material using a plurality of dental arch models that correspond to configurations at different steps of the orthodontic treatment.

[0027] In some variations, the step of fabricating a connected array of dental aligners comprises the steps of fabricating the dental aligners, and connecting the dental aligners in a connected array. The step of fabricating the connected array of dental aligners may include fabricating the dental aligners in a sheet of an aligner-making material, and cutting the sheet of the aligner-making material having the fabricated dental aligners to produce the connected array of dental aligners. [0028] ΗtfϊfiδM ftietMdsfof organizing dental aligners for a subject may include the steps of determining the sequence for a plurality of dental aligners to be used by the subject in an orthodontic treatment, wherein the dental aligners are configured to be applied in a plurality of steps in the orthodontic treatment to move the subject's teeth, and vacuum forming a connected array of dental aligners using a plurality of dental arch models that correspond to configurations of the dental aligners at different steps of the orthodontic treatment. In some variations, the step of vacuum forming the connected array of dental aligners comprises fabricating the dental aligners in a sheet of an aligner-making material using the plurality of dental arch models, and cutting the sheet of the aligner-making material having the fabricated dental aligners to produce a connected array of dental aligners. The dental aligners may be disposed in the array in the same sequence as the sequence that the plurality of dental aligners is to be used by the subject.

[0029] In some variations, the dental aligners are disposed in a one-dimensional array or a two- dimensional array.

[0030] The disclosed systems, methods, and apparatus for organizing dental aligners may provide convenient ways for a subject to organize and track the dental aligners he or she uses in an orthodontic treatment process. Dental aligners for a subject's treatment can be connected by connectors and disposed in an array. In some variations, the connectors can be broken off manually by a subject, allowing easy disconnection between the adjacent dental aligners.

[0031] ' The dental aligners to be used at different treatment steps can be organized in the same order as the sequence of the treatment steps. This may decrease the chance for errors when using the aligners. The systems and methods may be intuitive to use and inexpensive to produce. The systems and methods can also provide multiple dental aligners at one treatment step.

[0032] The array (or set) of the connected dental aligners provided may also be easily carried and stored. This can reduce or eliminate the need for a dedicated storage system for the dental aligners. Furthermore, these systems and methods may simplify or eliminate the need for labeling for the aligners.

[0033] In another aspect, systems are disclosed for storing and dispensing dental devices such as dental aligners, for example. In one example, a container for storing dental devices includes a container body adapted to hold the dental devices and a dispensing mechanism configured to dispense one of the dental devices when the dispensing mechanism is triggered. The container may further include a window configured to allow the dispensing of the dental device. In some variations, a spring enabled dispensing mechanism may be configured to dispense one of the stored denϊal"'aJ?iό'ef "ϊπ'k'TiM-Α and first-out (FIFO) order when the dispensing mechanism is triggered by the pressing of a release button. The dental devices may be dispensed in the order in which they are to be used.

[0034] Variations of the disclosed storing and dispensing systems may allow dental devices to be securely stored in a container body to protect them from damage, may be convenient, compact and portable, and may maintain a fixed order (e.g., FIFO) of the stored dental devices.

[0035] In yet another aspect, systems are disclosed for tracking dental devices such as dental aligners, for example. In one example, a system for tracking dental devices includes a label configured to be attached to the dental device. The label stores information about a patient's dental treatment. The stored information may include, but is not limited to, diagnostic information, design information, manufacturing information, treatment information, distribution information, and shipping information. For example, the stored information may include the patient's identification, the doctor 'a identification, the position of the dental device in a sequence of devices, and shipping information for the patient and the doctor. In some variations, the information may be stored by encoding it in the label. Stored information may be encoded in compressed form. In other variations, the information may be stored by encoding in the label a pointer that points to a location at which the information is stored or to a record or other data structure in which it is stored. The pointer may be used to access the information in a database, for example.

[0036] The system may further comprise a detector configured to extract data from the label. In one variation, the extracted data includes the shipping destination of the dental device.

[0037] In yet another aspect, methods are disclosed for tracking dental devices such as dental aligners. In one example, a method for tracking dental devices includes creating a data structure comprising information about a patient's dental treatment, storing the data structure in a label, attaching the label to a dental device, and extracting data from the data structure stored in the label. The information may include, but is not limited to, that described above. The data structure may comprise, for example, a record, an array, or any other suitable data structure known to one of ordinary skill in the art.

[0038] Systems and methods for tracking dental devices may utilize labels including, but not limited to, bar codes and radio frequency identification devices (RFID devices).

[0039] In another aspect, a system is disclosed for tracking use of a dental device by a patient. The dental device may be, for example, a dental aligner, a retainer, or a denture. The system comprises at"reast"oή'e' Sδrisoϊ'l!t6:''(detect use of the dental device by the patient. The system may further comprise at least one recorder to record data collected by the sensor. The recorder may record the time and duration of each use of the dental device by the patient, for example. In one variation, the system comprises a timer configurable to alert the patient to begin use of the dental device.

[0040] In some variations, the system further comprises a container in which the dental device may be stored when not in use by the patient. The sensor is included in the container. The sensor may detect whether the dental device is present in the container, and/or when the container is opened and closed, for example. The system may further comprise a recorder included in the container. The recorder may record times at which the dental device is removed from and returned to the container, for example. In other variations, a sensor and, optionally, a recorder may be attached to or embedded in the dental device.

[0041] These and other embodiments, features and advantages of the present invention will become more apparent to those skilled in the art when taken with reference to the following more detailed description of the invention in conjunction with the accompanying drawings that are first briefly described.

BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Figure 1 is a flow chart showing one method of fabricating a set of connected dental aligners for a dental treatment as described herein.

[0043] Figure 2 is a top view of one variation of a linear array of connected dental aligners.

[0044] Figure 3 is a top view of one variation of a two-dimensional array of connected dental aligners.

[0045] Figure 4 shows a table listing dental aligners for a subject's orthodontic treatment.

[0046] Figure 5 illustrates one example of an arrangement for fabricating an array of connected dental aligners for a subject's orthodontic treatment.

[0047] Figure 6 shows an example of a container for storing and dispensing dental devices.

[0048] Figures 7A and 7B show, respectively, cross-sectional and perspective views of portions of an example of a locking mechanism for a container cap at the upper end of the container of Figure 6. [00'49] FϊgureTsKd'WS ftrdMmple of a spring-load mechanism on the underside of a container cap.

[0050] Figure 9 shows an example of a door for a dispensing window in a front portion of a lower end of a dispensing container.

[0051] Figure 10 shows an example of a dispensing mechanism for dispensing dental devices from a container.

[0052] Figure 11 shows an example of a slideable back for a dispensing container.

[0053] Figure 12 shows an example of a structure comprising dental devices enclosed in bags attached in a stack to a support.

[0054] Figures 13A-13C show successive top views of an example of a structure comprising dental devices enclosed in chambers as seals are removed to successively open the chambers.

[0055] Figures 14A-14C are successive side views of the structure shown in Figures 13A-13C.

[0056] Figures 15A and 15B show exploded perspective and cross-sectional views of an example of a container for storing dental devices.

[0057] Figure 16 shows examples of smart labels applicable to tracking dental devices in some variations.

[0058] Figure 17 shows an exemplary data structure that can be stored in smart labels for tracking dental devices.

[0059] Figure 18 shows an example of a dental aligner in a container comprising a sensor that senses use of the dental aligner and a recorder that records data from the sensor.

DETAILED DESCRIPTION

[0060] The following detailed description should be read with reference to the drawings. The drawings, which are not necessarily to scale, depict selective embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention. " "[Oό'όϊ]

invention, it is to be understood that unless otherwise indicated, this invention need not be limited to applications in orthodontic treatments. As one of ordinary skill in the art having the benefit of this disclosure would appreciate, variations of the invention may be utilized in various other dental applications, such as fabrication of and/or treatment planning for dental crowns, dental bridges, and aligners. Moreover, it should be understood that variations of the present invention may be applied in combination with various dental diagnostic and treatment devices to improve the condition of a subject's teeth.

[0062] It must also be noted that, as used in this specification and the appended claims, the singular forms "a," "an" and "the" include plural referents unless the context clearly dictates otherwise. Thus, for example, the term "a tooth" is intended to mean a single tooth or a combination of teeth, "an arch" is intended to mean one or more arches (e.g. both upper and lower dental arches). Furthermore, as used herein, "calculating," and "formulating" may include the process of utilizing manual and/or computer calculations, such as those used to create a numeric representation of an object (e.g. a digital model) or to measure differences in tooth position. For example, a digital representation may comprise a file saved on a computer, wherein the file includes numbers that represent a three-dimensional projection of a tooth arch, hi another variation, a digital representation comprises a data set including parameters that can be utilized by a computer program to recreate a digital model of the desired object.

[0063] As used herein, the term "dental aligner" may refer to a dental device for rendering corrective teeth movement or for correcting malocclusion. One or more dental aligners can be worn on the subject's teeth so that a subject wearing the dental aligners will gradually have his or her teeth repositioned by the dental aligner "pushing" (or pulling) against the teeth, or gums (gingiva). As used herein, a "subject" may include any subject (human or animal) whose dental structure (e.g., teeth, gingiva, etc.) may be modeled by the devices, methods, and systems described herein, including orthodontic patients.

[0064] Examples and variations of systems, methods, and apparatuses for manufacturing, organizing, storing, and tracking dental devices such as removable dental aligners, for example, are described herein. As noted above, in some variations these systems, methods, and apparatuses may advantageously enable a patient to easily select the proper dental device from a series of dental devices to be worn in an intended sequence even where the dental devices are unmarked with respect to their position in the sequence.

[0065] The Detailed Description is separated into two broad sections to streamline its organization and to provide clarity. The first section discloses systems, methods, and app^atuses'tnlFma/t)e:"uied!teϊ organizing, storing, and dispensing dental devices. In some variations, these systems, methods, and apparatuses relate to connected dental aligners and to methods for their manufacture and use. In other variations, these systems, methods, and apparatuses relate to other structures and containers that may be used to store and/or to dispense dental devices such as dental aligners, for example.

[0066] The second section discloses systems, methods, and apparatuses for tracking dental devices such as dental aligners, for example. In some variations these systems, methods, and apparatuses relate to tracking dental devices through, for example, design, manufacturing, and/or distribution processes. In other variations these systems, methods, and apparatuses relate to tracking the use of dental devices by a patient.

[0067] One of ordinary skill in the art having the benefit of this disclosure would appreciate that systems, methods, and apparatuses described in the different sections can be implemented with each other in various combinations. The combinations are not limited to elements disclosed in one specific section. In some variations, the systems, methods, and apparatuses disclosed in the first section may be used in tracking (or tracking the use of) dental devices such as dental aligners. Similarly, in other variations the systems, methods, and apparatuses disclosed in the second section may be used in organizing, storing, and/or dispensing dental devices.

Organizing, Storing, and/or Dispensing Dental Devices

[0068] This section is further divided into several subsections to streamline its. organization and to provide clarity. One of ordinary skill in the art having the benefit of this disclosure would appreciate that systems, methods, and apparatus disclosed in one subsection may be used in combination with those disclosed in another subsection, and that combinations are not limited to elements disclosed in one specific subsection. The use of subsection headings is not intended to limit the disclosure in any way.

Connectors

[0069] One or more dental aligners may be connected by one or more connectors so that they are ordered or organized in a sequence reflecting the order that the dental aligners are to be used at different steps of an orthodontic treatment. In general, this means that two or more dental aligners corresponding to different sequential steps of an orthodontic treatment are fabricated before delivery or use by a subject, and connected so that the user or a practitioner (e.g., an orthodontist, dentist, dental technician, etc.) can separate the dental aligners sequentially in the order that the steps are to be followed. [0'07O]'' "U1He use"'bf a^eϊϊds of two or more dental aligners to treat a subject's teeth is described more fully in the related applications, incorporated by reference above. A set of dental aligners is designed based on the current and predicted position of the subject's teeth, and the aligners may then be fabricated. In some variations, the entire sequence of aligners may be designed and fabricated for use by the subject. In some variations, only a few of the aligners in a treatment series are manufactured at a time. The total number of aligners produced at any time may be ordered and connected as described herein.

[0071] For example, Figure 1 illustrates one method of fabricating and connecting a set of dental aligners for a dental treatment. Any of these steps may be performed manually or with machine (e.g., computer) assistance. In step 110, a practitioner determines a treatment plan for a subject. The treatment plan may specify, for example, the initial configurations, of the subject's teeth and the final configurations for the subject's teeth. In step 120, the number of treatment steps in the treatment plan may be determined. In step 130, the configuration of each tooth is determined at each treatment step. In step 140, one or a number of dental aligners can be specified for the subject to wear at each treatment step. The order of these aligners, as well as the shape of the aligners, may be determined during this process. The dental aligners may be fabricated in step 150. As mentioned, two or more of the dental aligners may be produced simultaneously or sequentially. The fabrication of these aligners is described more fully below. The aligners may be fabricated so that they are connected, or they may be fabricated separately and then connected (in step 160). Once connected, the aligners may be further packaged, or may be delivered as-is.

[0072] Any appropriate connector may be used to connect the plurality of dental aligners. For example, the connectors may be a physical link attached to each aligner (e.g., a frangible or detachable connector). In some variations, the connectors encompass at least a part of the aligners and thereby hold the aligners in the proper sequence or position. Two or more aligners linked by the connector(s) may be referred to as an array of aligners. As described more fully below, an array of aligners may comprise any number of aligners, arranged in any appropriate fashion (e.g., linearly, as a sheet, as a stack, etc.). Individual aligners may be removed from the array by removing the connector(s) linking the aligner to the array.

[0073] In some variations, the connectors are breakable connectors. For example, a connector may comprise a frangible connector. A frangible connector may be a manually breakable connector. A frangible connector may be made of a material that is brittle and can be broken by a person applying force using their hands. A frangible connector may comprise a polymer, ceramic," composite 'MateπaT""eϊc. In some variations, the frangible connector is serrated, scored, or may otherwise provide a fracture line or point that may guide or assist breaking the connector. For example, the frangible connector may have an hourglass (symmetrically tapered) shape, or any other appropriate shape providing a small cross-sectional area that is readily broken or separated.

[0074] The connectors may also be detachable connectors. For example, the connectors may comprise a fastener that can be unfastened, hi some variations, the connectors may include snaps, buttons, clasps, links, etc. Thus, the connectors may be single-use or reusable. The connectors may be attached directly to two or more aligners, or they may be indirectly attached. The connector may be a single piece, or it may be two or more pieces. For example, the connector may have two pieces that mate to connect two or more aligners. Thus, one part of the connector may be linked to one aligner, and another part of the connector may be linked to another aligner. The two aligners are connected when the parts of the connector are joined (e.g., mated, interlocked, or fastened).

[0075] A connector may be part of a larger frame. For example, a series of aligners may be linked to connectors that form a single frame. Thus, the aligners are connected to each other through a frame or framework. The connectors link the aligner to the frame. The frame may be a separate structure from the connectors, or the connectors may be parts of the frame. The frame may keep the aligners organized, and may also provide additional support or structure that may help store the aligners.

[0076] Aligners may be linked to other aligners by a single connector or by multiple connectors. For example, different connectors may link to different portions of an aligner. Two aligners may also be linked by more than one connector (including more than one type of connector).

[0077] As mentioned above, a connector may be directly attached to one or more aligners. For example, the connectors may be formed from the same material as the aligner. The connector may be fabricated at the time that the aligners are fabricated. For example, the connector may be a peg (e.g., a projection) or small piece of material that is left connecting two or more aligners after they have been fabricated. In some variations, the aligners are not fabricated together, but are connected after fabrication and linked to each other by being directly connected to one or more connectors. [0078) '

are directly connected to the connectors, the connectors and aligners may be attached in any appropriate manner. For example, the connectors may be attached via an adhesive (e.g., glue, epoxy, etc). Thus, the connector may include different materials that are connected to the aligner. In some variations, the connectors themselves comprise an adhesive that may be set into position and hardened. In one variation, the connector comprises a dissolvable material (e.g., a starch, etc.) so that the connector may be severed by exposing the connectors to a solvent (e.g., water, alcohol, etc.).

[0079] Connectors may connect to any appropriate region of a dental aligner. In general, it may be desirable for the connector to link to the outer surface of the dental aligner shell. For example, a connector may attach to a region of the dental aligner that does not interact with portions of the subject's mouth, or with other dental aligners, when the subject is wearing the dental aligner. In some variations, the dental aligners are linked to connectors on- the side of the outer region of the shell (e.g., between the tip region and the bottom region). In some variations, the connector connects to the inner portion of an aligner.

[0080] A connector may also be indirectly linked to an aligner and to other connectors. For example, an indirectly attached connector may secure the aligner (keeping the aligners in a predetermined sequence or position) by passing through a hole on the aligner, or may enclose a portion of the aligner. In some variations, the connector surrounds part of the aligner (or the entire aligner). For example, the connectors may be a set of joined chambers. In some variations, a connector comprises a series of chambers into which aligners fit. Each chamber may be closed off (e.g., by a removable cover) to hold the aligner therein. Thus, to remove the aligner, the chamber is opened, releasing the aligner.

[0081] The connectors may be separated manually or with the assistance of a tool or tools. For example, the connector may be manually severable by snapping, breaking, shattering, tearing, ripping, twisting, pulling, or the like, to apply enough force to remove the aligner. In some variations, the aligners themselves interlock, and the connector is a region of the aligner.

[0082] The connector may also be separated by a tool. For example, the connectors may be cut or broken by a blade, or devices having a blade (e.g., scissors, clippers, snips, etc). In some variations, the tools are specially adapted to remove the connector without damaging the aligner. For example, the tool my include a lip or sheath to protect the aligner as the tool cuts the connector. jj

arranged in an array. As described above, an array may be any appropriate arrangement of aligners including one-dimensional (e.g., linear) arrangements, two dimensional arrangements (e.g., a sheet of aligners), and three-dimensional arrangements. The aligners may be ordered within the array so that a subject or practitioner can remove an aligner from the array in the order in which the aligner is to be provided for use, consistent with the treatment of the subject. For example, the aligners may be ordered sequentially so that the aligner at one end of the array is the first aligner (e.g.., for the first week). As treatment progresses, the next aligner to be used is available at the end of the array, so that it can be easily identified and removed from the array for use. Thus, the array of connected aligners may be arranged so that the aligners are dispensed one (or two, e.g., when there are separate upper and lower aligners) at a time. Aligners corresponding to later periods of treatment may be accessed only after removing the aligners intended for earlier in the treatment.

Examples

[0084] Figure 2 shows one variation of an array of dental aligners. A linear array of adjacently connected dental aligners 210 includes a plurality of dental aligners 221-225 that are connected by a plurality of connectors 230. The aligners 221-225 are arranged in the same order as the treatment sequence to be used by the subject. For example, the first dental aligner in the linear series 221 is for the first treatment step; the second dental aligner 222 is intended for the second treatment step, and so on. The subject can break off each of the aligners 221-225 one at a time during the treatment. Thus, the aligners are arranged in the same order as the intended usage, which prevents the dental aligners 221-225 from being used out of the treatment sequence. The array of connected dental aligners may be easy to carry and store. This may also eliminate the need for a dedicated storage system for the dental aligners. Labeling the aligners can also be simplified or eliminated. For example, a label indicating the first aligner may be part of the connector 230, or may be attached to the connector. In one variation, the last aligner in the organized array 225 is connected to a label indicating that this is the last (and not the first) aligner.

[0085] Another variation of a connected array of aligners is shown in Figure 3. As in Figure 1 , the connectors are peg-like connectors that are directly connected to the aligners that they link. Figure 3 shows a top view of a two-dimensional array 300 of connected dental aligners 330 and 340. In this example, the dental aligners 330 and 340 are disposed in two linear arrays 310 and 320, similar to the linear array shown in Figure 1. Adjacent dental aligners 330 and 340 within or between the linear arrays 310 and 320 are connected by connectors 360. Thus, at least some of ''ffie"cbiinectbrs'ϊnclud!e'lMks"ϊo"four different aligners. The layout of a two-dimensional array structure can further help the subject to organize dental aligners. For example, in the example illustrated in Figure 3, a column can correspond to identical or similar dental aligners to be used at a specific treatment step. The subject can break off aligners in a particular column at a treatment step. In one variation, the column may correspond to an upper arch and lower arch aligner of the same treatment step. In some variations, the column may comprise duplicate or alternative aligners for the same treatment step. After the subject moves to the next treatment step, he or she can use the next column of aligners.

[0086] Figure 4 shows a table 400 that summarizes the dental aligners to be used for a subject's orthodontic treatment. The treatment can include a plurality of N steps. Each treatment step may include one or more copies of dental aligners. For example, CIl and C 12 may correspond to dental aligners for the first step, C21 and C22 may correspond to dental aligners for the second step, and so on. A marking, label, or other indicator (such as "CH" and "C 12") can be made on each of the dental aligners to further assist the tracking of the dental aligners for the subject, or the markings may occur on the connectors, or on a separate label connected to the aligner (e.g., via a connector) or to the connector. For example, in variations where the aligners are connected to a frame, the frame may include labels or markings. In general, the dental aligners used at each step can only be used for a short period of time and then are disposed. Details of disposable dental aligners are disclosed, for example, in the above referenced U.S. Patent Application No. 11/074,298, titled "DISPOSABLE DENTAL ALIGNER," filed March 7, 2005.

[0087] The connectors shown in Figures 2 and 3 are all frangible tab-type connectors that may be manually disconnected by breaking the connection between the connector and the aligner. The connector may be broken off so that the surface of the aligner is left smooth where it was attached to the connector. This may prevent the aligner from having a sharp or irritating edge which may decrease the comfort of a subject wearing the aligner. In some variations, the connector has a relatively large structural strength compared to the interface between the connector and the aligner. For example, in Figure 2, the connectors 230 have a central region that is larger than the tapered ends, where the connector links to the aligner. In some variations, the tapered ends of the connectors may also be configured to break in a known (e.g., stereotypical) pattern, such as a pattern that leaves the surface of the aligner relatively smooth. For example, the tapered ends may be creased, serrated, dimpled, perforated, etc.

far' end of the array of aligners shown in Figure 2 has a (partial) connector that is not shown linked to a second aligner 240. As mentioned above, connectors, including partial connectors, may be removed before wearing the aligner. In some variations, the connector may be left behind on the aligner, and the aligner may be used without removing the remaining portion of the connector.

Fabrication of Dental Aligners

[0089] Dental aligners as described herein can be fabricated in any appropriate fashion. For example, a number of processes disclosed in the above-referenced patent applications may be used to fabricate dental aligners, including dental aligners that are fabricated connected to each other as described.

[0090} In one variation, a digital dental aligner model specifies a shell portion including an outer surface and an inner surface to be in contact with the subject's tooth, a bottom portion to be placed near the gingiva of the subject's tooth, and a tip portion on the opposite side of the bottom portion. The digital dental aligner model may also define one or more wrinkles formed over at least one of the outer surface of the shell portion, the inner surface of the shell portion, and the bottom portion. An apparatus produces a physical dental aligner in accordance with the digital dental aligner model.

[0091] In another variation, the dental aligners are formed by a vacuum-forming process. The subject's dental arch model is placed on a base plate of a vacuum former machine. Referring to Figure 5, for example, a sheet 510 of aligner-making material can be made of a uniform distribution of a single material or comprise multiple layers of different materials. The sheet may comprise polymer materials, for example. Sheet 510 of aligner-making material is heated for a specified time to soften it, placed over the dental arch model in the vacuum former machine, and then vacuum formed around the dental arch model. In one example, a vacuum pump removes air at the bottom of the base plate to cause the softened aligner making material to relax and fittingly form around the surface the subject's dental arch model to produce a dental aligner 521 on the sheet 510.

[0092] A plurality of dental arch models can then be provided corresponding to the configurations of different treatment steps for the subject. The vacuum-forming process described above may be repeated using the dental arch models to produce aligners 522-525 on the sheet 510 of the aligner making material. The aligners 522-525 may be used by the subject at different treatment steps. The sheet 510 of the aligner making material is then cut out by a mechanicafMlgrra'lfeBi-tiitϊer? a puncher or a die cut along the gingival lines of each of the aligners 521-525. The cuts leave a plurality of connectors 530 to keep the aligners 521-525 connected in an array.

[0093] Details of making dental arch models for a dental treatment are disclosed, for example, in the above-referenced International Patent Application No. PC17US2005/039715, titled "METHODS AND APPARATUSES FOR MANUFACTURING DENTAL ALIGNERS," filed November 2, 2005.

[0094] In some variations, dental aligners are fabricated using Computer Numerical Control (CNC) based manufacturing such as milling, stereo lithography, and laser machining. A digital arch model is first obtained by scanning a subject's dental impression. A digital aligner model is then developed based on the digital arch model. The digital aligner model can provide input data to the CNC based manufacturing. Aligner components can be fabricated by CNC manufacturing techniques. The aligner components can include features for attaching aligners to each other, including the connectors. The aligner components can be automatically assembled by robotic arms under computer control. The dental aligners may therefore be obtained by assembling the aligner components. Connectors (e.g., frangible connectors) can also be fabricated as part of the aligner components or separately, and may also be robotically assembled, or manually assembled. The connectors may be attached to the aligner components and connect adjacent aligners in the set.

[0095] Dental aligners can also be fabricated by molding. Malleable casting material can be poured into a casting container containing the subject's arch model. The container may then be sealed. Heat, pressure or UV light may be applied to cast the material so that it is solidified. A dental aligner may be formed, and can be detached from the container. Breakable connectors can also be fabricated. The breakable connectors can then be latched or locked to the adjacent aligners in a set of dental aligners for a treatment.

[0096] The dental aligners described herein can be made of a fluid permeable material to allow oxygen and/or a subject's saliva to pass through, which may improve oral hygiene and comfort. The dental aligners can include wrinkled surfaces to eliminate or reduce relaxation problem commonly seen in removable dental aligners. The dental aligner can also comprise surface textures that simulate the cosmetic appearance of teeth or that aid with attachment. Disposable dental aligners can be used for a short period of time. A plurality of disposable aligners can be provided for a subject at a treatment step. The dental aligner (and/or the connector) can be made of plastics, polymers, urethane, epoxy, plaster, stone, clay, acrylic, metals, wood, paper, ceramics, andporcelamT The cterital aligner (and/or the connector) may comprise multiple layers, each comprising the same or different materials.

[0097] Details of making dental aligners using different techniques are disclosed, for example, in the above-referenced patent applications, including International Patent Application No. PCT/US2005/039715, titled "METHODS AND APPARATUSES FOR MANUFACTURING DENTAL ALIGNERS," filed November 2, 2005, U.S. Patent Application No. 11/074,297, titled "PRODUCING WRINKLED DENTAL ALIGNER FOR DENTAL TREATMENT," filed 3/7/2005, and U.S. Patent Application No. 11/074,300, titled "FLUID PERMEABLE DENTAL ALIGNER," filed 3/7/2005.

Use of Connectors and Connected Dental Aligners

[0098] As described above, the aligners may be sequentially arranged, so that they may be accessed and used in the proper order. In operation, the subject receiving an array of aligners may remove an aligner from the array in order to place the aligner against his or her teeth for treatment to straighten or otherwise manipulate the teeth. Removing the aligners releases the aligner from the array, and may require breaking the connector (e.g., frangible connectors), cutting the connector or removing the connecter from around or through the aligner, as described above.

[0099] Once the aligner has been removed, it may be used by the subject immediately, or it may undergo further processing. For example, the aligner may be smoothed, coated, rinsed, etc., in order to prepare the aligner for use.

[00100] The aligners (e.g., an array of aligners) may be part of a dental treatment system that includes additional components. For example, a dental treatment system may include a dispenser for dispensing the aligners in the order in which they should be used. A dispenser may comprise packaging. For example, the dispenser may be a tube or box in which a column of aligners is kept in the desired treatment order. The dispenser may have an opening through which each aligner may be removed, in the order that it is to be used by the subject. For example, the dispenser may be a tube for holding aligners in the desired order. In some variations, the connector comprises a dispenser.

[00101] A dental treatment system may also include instructions for using the aligner. The instructions may also include instructions for removing the aligner from an array of aligners, and/or for preparing the aligner for use. The instructions may also include instructions for inserting and wearing the aligner. These instructions may be in any appropriate form, including written, electronic, recofded"'(e':'g., video, audio, etc.). In some variations, the instructions may be pictographic. The instructions may be written in any appropriate language.

Other Structures and Containers

[00102] Described next are other structures and containers that may be used to store and/or to dispense dental devices such as dental aligners. In some variations, these structures and containers may include or present dental devices in a manner that allows doctors or patients to intuitively select and use the dental devices in an intended order. For example, the dental devices may be dispensed in the order in which they are intended to be used, or access to the dental devices may be restricted in a way that leads to selection and use of the dental devices in the intended order.

[00103] Referring now to Figure 6, one example of a container 600 for storing and dispensing dental devices includes a container body 610, a container cap 620 that can seal the upper end of the container body 610, a dispensing window 630 in the lower front side, and a release button 640. The dispensing container 600 can store dental devices such as, for example, dental aligners, dental brackets, dental arch models, tooth models, and bases or base components for tooth models. The dental devices can stack up on each other inside the container body 610. The dental devices may be dispensed out of the dispensing window 630 by, pushing the release button 640. The dental devices may be dispensed in the order they were stored, that is, "First In, First Out" (FIFO). The container body 610 can be, for example, cylindrically shaped and made of a waterproof material that can withstand rough handling such that the dental devices stored in the container will not be damaged if the container is accidentally dropped on to the floor.

[0100] Details of the fabrication of dental aligners, dental arch models, dental tooth models, and bases for tooth modela that may be stored and/or dispensed in container 600 are disclosed, for example, in the above-referenced International Patent Application No. PCT/US2005/039715, titled "METHODS AND APPARATUSES FOR MANUFACTURING DENTAL ALIGNERS," filed November 2, 2005.

[0101] The container cap 620 may be constructed so that it can snap on to container body 610 to be closed. As shown in Figures 7A and 7b, for example, the upper end 720 of the dispensing container 600 may include a groove 730 around its rim and the inner face of the container cap 620 may include a protrusion 710 that fits the groove 730. When the container cap 620 is pressed down on the upper end 720 of the dispensing body 610, protrusion 710 snaps into the groove 730 to lock container cap 620 to the container body 610. [0102] As srϊowri in Figure K, "the container cap 620 may include a tensile spring 810 fixed to its underside. A pressure plate 820 may be connected to the end of the spring 810. Spring loaded pressure plate 820 pushes the dental devices stored in the container body 610 downward to ensure that the dental devices are tightly packed inside the container body 610. The spring load may also maintain the dental device at the bottom in registry with the dispensing window 630. When uncompressed, the spring 810 can reach the bottom of the container body 610 such that the last dental device in the container body 610 can be dispensed through the dispensing window 630.

[0103] The dispensing window 630 may be closed by a door 920 as shown in Figure 9. The door 920 can be locked by a latch 930 fixed on the door 920 to prevent dental devices, from falling out of the container body 610. Alternatively, the door 920 can also be kept closed by a spring mechanism that automatically closes the dispensing window 630 after each extraction of a dental device.

[0104] Storing and dispensing container 600 includes a dispensing mechanism. As shown in Figure 6, the automatic dispensing mechanism includes a release button 640 located below the dispensing window 630. Figure 10 shows details of an example dispensing mechanism. Referring to Figure IQ, release button 640 is attached to a spring. Two more springs 1020 are attached to the back wall of the container body 610. The ends of the springs 1020 are attached to stoppers 1030 and pushing sticks 1040, 1045 that are hinged at hinges 1050-, 1055.

[0105] When the release button 640 is- pressed,, the spring attached to it is. compressed, the stoppers 1030 move forward causing the pushing sticks 1040, 1045 to move forward. This forward motion moves the bottom most dental device in the container body 600 to partially move out of the dispensing window 630. As soon as the partially popped out dental device is removed, the springs 1020 retract, moving the push sticks 1040, 1045 to the initial positions. The dental devices above are pushed downwards by the spring 810 on the container cap 620. The spring attached to the release button 640 returns to its normal position, pushing the release button 640 outwards. This motion causes the stoppers to return to their respective positions as well. The dispensing container 600 is now ready to dispense another dental device.

[0106] The described arrangement allows only one dental device such as an aligner to be dispensed at a time from container 600. In particular, a patient can dispense one of the stored dental devices only by first dispensing the dental devices ahead of it in the stack of stored dental devices. In some variations, the dental devices are intended to be used by a patient in a particular sequence and are stacked in container 600 such that they are dispensed in that sequence. In such variatioris,' rdeMl'Wieels "accessible to the patient through the dispenser only if the dental devices prior to it in the sequence have been accessed through the dispenser.

[0107] Referring to Figure 11, in another variation a storing and dispensing container 1100 includes a slide-able door 1110 on the back of a container body 1120. The slide-able door 1110 can slide into slots 1130 on the container body 1120. The dental devices 1140 are packed in a stack in FIFO order. The dental devices 1140 can be tagged by tags 1150 that can be barcodes or RFID devices. The tags 1150 may face backward such that they can be read or scanned once the slide-able door 1110 slides open. The tags can also be replaced or changed if the plans for the dental devices are changed.

[0108] In another variation, the lower edge 1160 of the slide-able door 1110 has a sharp edge that can be used to cut off or open packaging material in which the dental devices are packed. The cut-open packages containing the dental devices can be dispensed and then the dental devices may be conveniently taken out of their packages by a user.

[0109] In another example, Figure 12 shows a structure 1210 comprising two or more bags 1215, 1220 each enclosing one or more dental devices (e.g., dental aligners) 1225, 1230. Bags 1215, 1220 are attached in a stack to support 1230. In one variation, support 1230 is a cardboard sheet and bags 1215, 1220 are plastic bags attached to support 1230 by, for example, an adhesive or one or more staples. Structure 1210 may be further enclosed or packaged for shipping in for example, a conventional cardboard shipping box (not shown). Although in Figure 12 only two bags are shown attached in a stack to support 1230, other variations may include more bags and more dental devices. As a consequence of the stacking, the bag currently at the top of the stack (bag 1220 in Figure 12) must be opened and/or detached from support 1230 before the next bag in the stack (bag 1215) maybe easily accessed and/or opened.

[0110] In some variations, the dental devices are intended to be used in a particular sequence, each bag of dental devices corresponds to a different position in the sequence, and the bags are stacked in the sequence of use with the first in the sequence on top. Bags containing multiple dental devices may include duplicates or, for example, upper and lower dental devices such as dental aligners to be used at the same time. In such variations, a dental device is easily accessible to the patient only if the dental devices prior to it in the sequence have been accessed by, for example, removal of their bags from the stack. [Dill] S'ϊractufe l210"Showή"ϊn Figure 12 may also be viewed as an example of connectors

(bags 1215, 1220) connecting dental devices 1225, 1230 in a sequence, as described above in the sections relating to the use of connectors and connected dental aligners.

[0112] Referring to Figures 13A-3C (top views) and Figures 14A-14C (side views), in another example a structure 1310 comprises a plurality of chambers 1315A-1315C each enclosing one or more dental devices (e.g., dental aligners) 1320A-1320C. As shown in the figures, in one variation the chambers are arranged side-by-side in a series and closed by a plurality of partially overlapping covers 1325A-1325C arranged in a stack over the chambers. The covers may be, for example, foil sheets attached to the chambers and to each other by an adhesive, for example. The covers are configured so that removal of each successive cover opens one chamber in the series and removes one layer of the stack of covers from the succeeding chambers in the series. As a consequence of this configuration, a chamber may be opened only if the chambers prior to it in the series have been opened.

[0113] As shown in Figures 13B and 14B, for example, removal of top cover 1325 A (Figure 14A) opens chamber 1320A and removes one layer of covers from chambers 1320B and 1320C. Subsequent removal of cover 1325B opens chamber 1320B and removes another layer of covers from chamber 1320C, as shown in Figures 13C and 14C. Chamber 1325C maybe subsequently opened by removing cover 1325C. Although only three chambers 1320A-1320C and three covers 1325A-1325C are shown in this example, this scheme of successively opening chambers may be extended to include additional chambers.

[0114] In some variations, the dental devices 1320A-1320C are intended to be used in a particular sequence, chambers 1315A-1315C correspond to a different positions in the sequence, and the dental devices are arranged in the chambers in the sequence of use with the earliest in the sequence located in the chamber that opens first (i.e., chamber 1315A). In such variations, a dental device is accessible to the patient only if the dental devices prior to it in the sequence of use have been accessed.

[0115] In another example, dental devices such as dental aligners, for example, are stacked in a container and accessed by the patient through an open (e.g., temporarily uncapped) end of the container. In one variation, the container may be cylindrical or semi-cylindrical and may have a cross-sectional dimension approximately that of the stack of dental devices. The container may be configured (e.g., the cross-sectional dimension may be chosen) such that only one dental device at a time is accessible through the end of the container. In one variation the dental devices stacked" in the WMaϊϊϊBrfnay be separated by removable partitions such as, for example, trays or transparent sheets.

[0116] In some variations, the dental devices are stacked in the container in a sequence in which they are intended to be used and accessed by the patient in that sequence through the open end of the container. In such variations, a dental device is accessible to the patient through the open end of the container only if the dental devices prior to it in the sequence have been accessed (e.g., removed).

[0117] In another variation, Figures 15A and 15B show exploded perspective and cross- sectional views, respectively, of a dental device container 1500. Container 1500 comprises a cylindrical body 1510 having a closed bottom 1520 and an open top 1530 which may be closed by a removable lid 1540. A removable tray 1550 may be positioned in cylindrical body 1510 and supported by supports 1560. When tray 1550 is positioned in cylindrical body 1510 and open top 1530 is closed by removable lid 1540, container 1500 comprises a lower chamber 1570 (defined by tray 1550 and closed bottom 1520) and an upper chamber 1580 defined by tray 1550 and removable lid 1540. One or more dental devices (not shown) may be stored in the upper chamber. Similarly, one or more dental devices may be stored in the lower chamber.

[0118] In one variation, the dental devices stored in the upper chamber are intended to be used prior to the dental devices stored in the lower chamber. In this variation, the dental devices stored in the bottom chamber may be accessed through open top 1530 only after the dental devices stored in the upper chamber 1580 and the tray 1550 have been removed from container 1500.

Tracking Dental Devices

[0119] The design, manufacture, distribution, and use of dental aligners, for example, involves many steps and may involve handling of the dental aligners and related information by several entities. Typically, a dentist or orthodontist examines and diagnoses a patient in the U.S., and then a treatment plan including a series of dental aligners is designed by another entity based on information provided by the dentist or orthodontist. The dental aligners are then fabricated according to the designs by a manufacturer, which may be yet another entity and is often located outside of the U.S. After fabrication, the dental aligners are typically shipped to an operator or a distributor in the U.S., who then ships the dental aligners to the dentist or patient. The dental aligners must then be properly used at the different steps of the orthodontic treatment. [012OJ Denfarmϊgn'έϊs'fόr τriaiϊy different patients, prescribed by many different dentists and orthodontists, may be at the various steps of design, manufacturing, distribution, and use at any given time. The large number of parties and locations involved, the number of dental aligners, and the requirement that the dental aligners be used in a particular treatment sequence make tracking the dental aligners through design, manufacturing, distribution, and use difficult but important.

[0121] This section discloses systems, methods, and apparatuses that may be used to track dental devices such as dental aligners, for example, through design, manufacturing, and distribution processes and/or to track the use of the dental devices by patients. In some variations, these systems, methods, and apparatuses may help ensure that a patient receives the correct set of dental devices and then properly uses them.

[0122] In some variations, dental devices such as dental aligners, for example, are tracked using labels storing information about the patient's dental treatment and detectors configured to extract information from the labels. A computer may be configured to interpret the extracted information.

[0123] The stored information may include, but is not limited to, diagnostic information, design information, manufacturing information, treatment information, distribution information, and shipping information. In some variations, the information stored in the labels may be altered, erased, updated, or added to. Information may be stored in a label by encoding it in the label, for example. Stored information may be encoded in compressed form. Information may also be stored in a label by encoding in the label a pointer that points to a location at which the information is stored or to a record or other data structure in which it is stored. The pointer may be used to access the stored information in a database, for example.

[0124] The labels may be attached to or embedded in the dental device, attached to a package or container containing the dental device, and/or attached to papers, files, or other objects related to the dental device or to the patient's treatment plan, for example. The labels may comprise, for example, bar codes (e.g., UPC bar codes) 1610 and smart labels such as radio frequency identification (RFID) tags 1620, 1630 as shown in Figure 16.

[0125] In one exemplary process, a dentist or orthodontist examines a patient and then submits the patient's case for treatment with dental aligners. Typically, the doctor will complete a prescription form and submit it to the designers. A label uniquely identifying the case is then generated in response. The label may include (or include a pointer to) information including, but nόf limitedfόT'tlϊe-patiέϊft's identification, the doctor's identification, shipping information for the patient and the doctor, and information from fields in the prescription form. If the doctor submits the prescription form over the internet, for example, the doctor may receive a copy of the label at the time the case is submitted. Typically, the doctor will also submit a copy of the prescription form, including the case label, with upper and lower impressions of the patient's tooth arches, a wax bite, x-rays, and a photo of the patient's face and smile. The case label may used to identify and track this material.

[0126] As the patient's case proceeds through design, manufacturing, and distribution, the case label may be used to track where the case is at any given time. In one variation., the tracking is accomplished using enterprise resource planning (ERP) software. For example, if an individual such as a designer, manufacturer, or shipper needs to work on or with the case, that individual reads (e.g., scans) the case label and then reads (e.g., scans) a personal identification to assign the case to himself or herself. This event is recorded by ERP software. The status of the case can then be determined by consulting the ERP system.

[0127] After submission of the case and generation of the case label, a treatment plan and a corresponding series of dental aligners are designed for the patient. In some variations, this treatment plan is verified by the patient's dentist or orthodontist. The case is then transferred to manufacturing.

[0128] After the dental aligners have been manufactured and disinfected, they are packaged and sorted according to their shipment dates. The dental aligners may be sorted for shipment in batches that include dental aligners for multiple patients and that include dental aligners prescribed by different dentists and orthodontists. A case label may be attached to each dental aligner and/or to each dental aligner package. At this stage, case labels associated with individual dental aligners may include the case information described above as well as the stage of the treatment process to which the dental aligner corresponds and the shipment batch to which it belongs. In some variations, the patient, dentist, or orthodontist may be able to access a web site to verify the accuracy of the dental aligners before they are shipped.

[0129] Next, the dental aligners are shipped to a distributor for further distribution to patients and/or dentists and orthodontists. When the dental aligners are shipped, the case labels are read (e.g., scanned) to confirm shipping and to record the event in the ERP database. In some variations, the patient, dentist, or orthodontist may be able to access this database to review the shipping information. Reports regarding these shipments, including the number of jobs/cases shipped during a given time period, may also be generated from the database. [0130] Upon receiving a' baϊcl of dental aligners from manufacturing, the distributor reads

(e.g., scans) the case label for each dental aligner. This reading (e.g., scanning) results in the generation of events in the ERP database which indicate that all the dental aligners of this batch shipment have been received by the distributor. In some variations, if a manager in manufacturing wants to know if a particular dental aligner made it to the distributor, for example, the manager can generate a report with the ERP software and determine the location of the particular dental aligner. The reading (e.g., scanning) also extracts the final shipping destination for each dental aligner.

[0131] The distributor next ships the dental aligners according to the shipping destinations extracted from the case labels. In some variations, the first dental aligner in each treatment sequence is shipped to the patient's dentist or orthodontist, and subsequent dental aligners are shipped directly to the patient. All dental aligners, to be shipped to a particular doctor may be assembled into a single package. In some variations, a tracking number will be assigned to each of these shipments by the shipping company. This shipping company tracking number may be stored in the ERP database in association with the case labels and, in some variations, accessed by the patient, dentist, or orthodontist.

[0132] In some variations the case labels comprise bar codes such as, for example, UPC (Universal Product Code) bar codes. In other variations, the case labels comprise smart labels such as RFID tags. RFID tags are minute programmable read and write labels. Common types of RFID tags include inductively coupled RFID tags and capacitively coupled RFID tags.

[0133] An inductively coupled RFID tag includes three main components: a microprocessor that can be in varying sizes, a metal coil, and an encapsulation that wraps around the chip and coil. The encapsulation is typically made of glass or polymer materials. The metal coil normally includes copper or aluminum wires that are wound around a transponder. The metal coil serves as the tag's antenna. The tag transmits signals to a reader, with read distance determined by the size of the coil antenna. These coil antennas can operate at 13.56 MHz. Inductive RFID tags are inductively powered by the magnetic field generated by the reader. The tag's antenna picks up the magnetic energy. The tag communicates with the reader by modulating the magnetic field to retrieve data from the reader and transmit data back to the reader.

[0134] Capacitively coupled RFID tags do not comprise a metal coil and use a small amount of silicon comparing to the inductively coupled RFID tags. A capacitively coupled tag includes three main components: a microprocessor, conductive ink, and a paper substrate. The microprocessor can be, for example a silicon chip 3 mm2 that can store 96 bits of data which allows tn'e storage 'of tftfl!ϊόnS'lof:!inique product numbers. The conductive ink can be a carbon- based ink that is printed in an image pattern on the paper substrate. The patterned conductive ink acts as the antenna for the capacitively coupled RFDD tag.

[0135] Capacitively coupled RFED tags are more flexible and of lower cost than inductively coupled RFID tags. The cost of capacitively coupled tags can currently be as low as 50 cents, and is expected to trend lower in the future. Capacitively coupled RFID tags are powered by electric fields generated by a reader rather than magnetic energy as in the case of inductively coupled RFID tags. The detection range for capacitively coupled tags is more limited than for inductive tags.

[0136] In some variations, the use of RFID tags allow case labels to be read while the dental devices are stacked up, which is more convenient and provides higher throughput than barcode scanners. The RFID tags can also be recycled by removing them from the used dental devices and reprogramming them for a new batch of dental devices. The multiple uses also lower the effective costs of the RFID tags.

[0137] In some variations, case labels comprising RFID tags can be embedded inside the dental devices or inside a package containing the dental devices. Such case labels do not have to be visible from outside of the dental device or the package. For example, the components of a tooth model, different tooth models of a physical dental arch model, a base or different base components can all be labeled by embedded case labels so that they can be tracked.

[0138] One example of a data structure that may be stored in case labels and used in the tracking methods disclosed herein is shown in Figure 17. The data structure includes a batch box 1700 that can comprise a doctor box 1710, a job box 1720, and patient boxes 1730. The doctors and their individual patients are identified^ respectively, in the doctor boxes 1710 and the patient boxes 1730. The jobs/cases with which first-step aligners are associated are specified in job boxes 1720.

[0139] The use of dental devices such as dental aligners, for example, may also be tracked. In some variations a system for tracking use of a dental device comprises a sensor that detects the identity (e.g., sequence position) of the dental device, detects use of the dental device, detects changes in the dental device that result from use or passage of time, and/or detects changes in the dental device's environment (e.g., in the patient's mouth.) The system may also comprise a recorder that records data collected by the sensor. This data may be downloadable to a computer, for example, ϊbf "analysis'. " THe "system may also comprise a transmitter that maybe used, for example, to transmit the data or to transmit other signals relating to the data to other devices.

[0140] The sensor may comprise, for example, one or more of a timer, a weight sensor, a pressure sensor, an optical sensor, a moisture sensor, a chemical sensor, an RFID sensor, a color sensor, a blood sugar sensor, a temperature sensor, or a pulse sensor. Color sensors may be used, for example, to detect color changes in the dental device over time. Pressure sensors may be used, for example, to detect changes in forces applied by or to the dental device over time and/or to detect corresponding changes in the shape of the dental device. Moisture sensors and chemical sensors may be used, for example, to detect, and to detect changes in, moisture and chemicals in the patient's mouth.

[0141] The recorder may comprise for example, a memory chip. In some variations, the recorder comprises a communications port enabling recorded data to be downloaded.

[0142] In one variation, one or more sensors detect, and a recorder records, the identity of a dental device and the time and duration of each use of the dental device by the patient. The sensor may determine the identity of the dental device by reading an RFH> tag attached to the dental device, for example. Other types of data, including but not limited to those listed above, may also be sensed and recorded. The recorded data may be subsequently downloaded for analysis.

[0143] In one variation, the tracking system comprises a timer configurable to alert the patient to begin using the dental device. The system may further comprise a transmitter that transmits a signal to the patient to alert the patient to begin using the dental device. The transmitter may transmit the signal to the patient's cell phone, for example.

[0144] Methods for tracking use of the dental device comprise using the tracking system to collect and, optionally, to record data relating to the use of the dental device.

[0145] Referring to Figure 18, in some variations the system further comprises a container 1805 in which a dental device 1810 may be stored when not in use by the patient. Container 1805 comprises a sensor 1815 and, optionally, a recorder 1820. The sensor may detect, for example, the identity of the dental device, whether the dental device is present in the container, and/or when the container is opened and closed, for example. The presence of the dental device in the container may be determined for example, by detecting the weight of the dental device, pressure applied by the dental device, moisture associated with the dental device, or an RFID tag embedded in or attached to the dental device. The presence of the dental device may also be detected optically, tor example"."" The recorder may record times at which the dental device is removed from and returned to the container, for example.

[0146] In some variations the sensor and (optional) recorder are embedded in or attached to the dental device, or attached to the patient's teeth.

[0147] In another variation, the tracking system further comprises embedded software that can detect whether a patient's use of the dental device complies with a treatment schedule. Non- compliance may result in an alarm being triggered, for example. In another variation, drugs such as emergency drugs, for example, may be embedded in the dental device and their release may be regulated based on data detected by the sensor. In another variation, the tracking system can recognize the existence of an emergency and contact help (e.g., dial 911) based on data detected by the sensor.

[0148] This invention has been described and specific examples of the invention have been portrayed. While the invention has been described in terms of particular variations and illustrative figures, those of ordinary skill in the art will recognize that the invention is not limited to the variations or figures described. In addition, where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art will recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. Therefore, to the extent there are variations of the invention, which are within the spirit of the disclosure or equivalent to the inventions found in the claims, it is the intent that this patent will cover those variations as well. Finally, all publications and patent applications cited in this specification are herein incorporated by reference in their entirety as if each individual publication or patent application were specifically and individually put forth herein.

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Classifications
International ClassificationA61C8/00, A61C3/00
Cooperative ClassificationA61C19/02, A61C7/08
European ClassificationA61C7/00
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