CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This patent application claims priority to U.S. Provisional Patent Application No. 62/521,166, titled "AUTOMATIC DETECTION OF TOOTH TYPE AND ERUPTION

STATUS," filed on June 16, 2017, which is herein incorporated by reference in its entirety.

INCORPORATION BY REFERENCE

[0002] All publications and patent applications mentioned in this specification are incorporated herein by reference in their entirety to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

BACKGROUND

[0003] In pediatric cases, orthodontic aligners are often used before all of the patient's permanent teeth have erupted. Detection of erupting teeth may help prevent the aligner from impinging on or contacting erupting teeth, which can stop eruption of the tooth or injure the patient.

[0004] In many existing techniques, a medical professional manually determines the eruption status and tooth type of a patient's teeth. This may require a physical inspection of the teeth or of images/scans of the teeth, and a judgment by the medical professional as to the eruption status and tooth type, adding time and expense.

SUMMARY OF THE DISCLOSURE

[0005] Implementations address the need to provide an automated tooth detection eruption detection system to automatically, effectively, and accurately predict tooth type and eruption status in dental patients, with a high degree of accuracy. The present application addresses these and other technical problems by providing technical solutions and/or automated agents that automatically detecting tooth type and eruption status in dental patients. Automatic detection of tooth state (e.g., tooth type and/or eruption status) may provide the basis for implementation of automated orthodontic treatment plans, design and/or manufacture of orthodontic aligners (including series of polymeric orthodontic aligners that provide forces to correct malocclusions in patients' teeth).

[0006] In general, example apparatuses (e.g., devices, systems, etc.) and/or methods described herein may receive a representation of a patient's teeth, and in some cases clinical information about the patient, to determine one or more tooth eruption indicators related to a patient's teeth. A "tooth eruption indicator," as used herein, may include an indicator of a tooth related to eruption. Examples of tooth eruption indicators include eruption states of a tooth. Examples of eruption states include eruption statuses (e.g., whether a tooth has fully erupted, partially erupted, or not erupted at all) and eruption permanentness statuses ((e.g., whether a tooth is a primary/baby tooth or a permanent tooth). In some implementations, the eruption status, tooth type (e.g., primary, permanent, etc.), and/or other features related to the patient's teeth may be determined. These apparatuses and/or methods may present the tooth eruption indicators, and may provide or modify a treatment plan, including an orthodontic treatment plan. The apparatuses and/or methods described herein may provide instructions to generate and/or may generate a set or series of aligners, and/or orthodontic treatment plans using orthodontic aligners that incorporate the eruption status and primary/permanent tooth type. The apparatuses and/or methods described herein may provide a visual representation of the patient's teeth including the eruption status and primary/permanent tooth type.

[0007] A "patient," as used herein, may be any subject (e.g., human, non-human, adult, child, etc.) and may be alternatively and equivalently referred to herein as a "patient" or a "subject." A "patient," as used herein, may but need not be a medical patient. A "patient," as used herein, may include a person who receives orthodontic treatment, including orthodontic treatment with a series of orthodontic aligners.

[0008] Any of the apparatuses and/or methods described herein may be part of a distal tooth scanning apparatus or method, or may be configured to work with a digital scanning apparatus or method.

[0009] As will be described in greater detail herein, automatically determining the eruption status and/or primary or permanent tooth type of a target tooth (e.g., for each of a patient's teeth) may include collecting a 3D scan of the patient's teeth. Collecting the 3D scan may include taking the 3D scan, including scanning the patient's dental arch directly (e.g., using an intraoral scanner) or indirectly (e.g., scanning an impression of the patient's teeth), receiving the 3D scan information from a separate device and/or third party, receiving the 3D scan from a memory, or the like.

[0010] Additional information may be collected with the 3D scan, including patient information (e.g., age, gender, etc.).

[0011] The 3D scan information may be standardized and/or normalized. Standardizing the scan may include converting the 3D scan into a standard format (e.g., a tooth surface mesh), and/or expressing the 3D scan as a number of angles (e.g., vector angles) from a center point of each tooth, etc. In some variations, standardizing may include normalizing the 3D scan using another tooth, including stored tooth values.

[0012] The standardized 3D scan information may then be processed to extract one or more features that may be used to automatically determine if a tooth is erupted, partially erupted, or un-erupted and/or the type of tooth; specifically, if the tooth is a primary tooth or a permanent tooth. This information may be used to automatically and accurately label the teeth of the 3D model, e.g., by numbering the teeth in a standard tooth numbering.

[0013] For example, a method of automatically determining the eruption status and primary or permanent tooth type of a target tooth may include: gathering, in a computing device, a three- dimensional (3D) model of the patient's teeth including the target tooth; standardizing the 3D model of the target tooth; applying, in the computing device, a principal component analysis (PCA) of the dental features of the target tooth to obtain PCA features; determining an eruption status and primary or permanent tooth type of the target tooth based on the PCA features; and outputting the eruption status and primary or permanent tooth type of the target tooth.

[0014] Note that although there are examples provided herein using PCA, other eigenvector- based multivariate analyses may be used. PCA is proposed because it may be automatically performed using know techniques including computing PCA using a correlation technique and/or a covariance technique, iterative methods including but not limited to non-linear iterative partial least squares techniques.

[0015] Standardizing may include identifying a predetermined number of angles relative to a center point of the target tooth. Any appropriate method may be used to determine the center of the tooth. For example, the center of the tooth may be determined from a mesh point

representation of each tooth (e.g., from a segmented version of the 3D scan representing a digital model of the patient' s teeth) by determining the geometric center of the mesh points for each tooth, by determining the center of gravity of the segmented tooth, etc. The same method for determining the center of each tooth may be consistently applied between the teeth and any teeth used to form (e.g., train) the systems described herein.

[0016] Standardizing may be distinct from normalizing. As used herein, standardizing may involve regularizing numerical and/or other description(s) of a tooth. For example, standardizing may involve regularizing the order and/or number of angles (from the center of the tooth) used to describe the teeth. The sizes of the teeth from the original 3D scan may be maintained.

[0017] Any of the methods and systems described herein may be determine for each tooth in a dental arch if that tooth is a primary tooth or a permanent tooth and/or if the tooth is erupted, un-erupted or partially erupted. Thus, any of these methods may determining for one or more (e.g., all) of the patient's teeth in the 3D scan of the patient's arch if the tooth is a primary erupted, permanent partially erupted/un-erupted, and/or permanent erupted tooth. In any of these methods and systems, the system may use this information to label a digital model of the patient's teeth with an indicator for each tooth for which the eruption status and/or

primary/permanent description has been determined. For example, the apparatuses and/or methods described herein may output (by display, transmission, etc.) a 3D model of the patient's teeth labeling each tooth as one of: primary erupted (or just "primary"), permanent partially erupted/un-erupted, and/or permanent erupted tooth (or just "permanent").

[0018] The 3D scan of the patient's teeth may be collected in any appropriate manner that permits it to be later manipulated by the method or apparatus for standardization, feature extraction and determining eruption status and/or permanent/primary status. For example, gathering may include taking the 3D model of the patient's teeth directly or indirectly form the patient's teeth. For example, gathering may include receiving a 3D model of the patient's teeth from an intraoral scanner. Gathering may include receiving the 3D model from a scan of a mold of the patient's teeth.

[0019] Any of the apparatuses and/or methods described herein may include gathering patient information about the patient, wherein the patient information includes one or more of: patient age, eruption sequence, measured space available for eruption, and patient gender; further wherein determining an eruption status and primary or permanent tooth type of the target tooth is also based on the patient information. Patient information may be taken directly or indirectly from the patient, including by asking and/or receiving patient questionnaire information, extracting patient information for a patient's electronic records, etc.

[0020] Any appropriate features may be extracted from the prepared (e.g., standardized and/or normalized) teeth. For example, in some variations, features may include a principal component analysis (PCA) for each of the teeth in the dental arch being examined. Additional features (e.g., geometric descriptions of the patient's teeth) may not be necessary (e.g., PCA alone may be used) or it may be used to supplement the PCA of each tooth. PCA may be performed on the standardized teeth automatically using any appropriate technique, as discussed above, including using modules from existing software environments such C++ and C# (e.g., ALGLIB library that implements PCA and truncated PCA, MLPACK), Java (e.g., KNIME, Weka, etc.), Mathematica, MATLAB (e.g., MATLAB Statistics Toolbox, etc.), python (e.g., Matplotlib python library, Scikit-learn, etc.), GNU Octave, etc.

[0021] In any of the methods an apparatuses described herein the eruption status and primary or permanent tooth type may be determined automatically (e.g., using one or more processors) based on information extracted from the standardized 3D scan. Before or as part of the standardizing process, the 3D model of the patient's tooth may be segmented into individual teeth and/or normalized. For example, the 3D scan of the patient's arch may be transmitted to and processed by a segmentation engine that divides the 3D scan into individual teeth and/or gingiva.

[0022] For example, the method and/or apparatus may determine an eruption status and primary or permanent tooth type of the target tooth based on the PCA features by applying machine learning algorithms selected from the group consisting of Decision Tree, Random Forest, Logistic Regression, Support Vector Machine, AdaBOOST, K-Nearest Neighbor (KNN), Quadratic Discriminant Analysis, and Neural Network. For example, machine learning techniques may be used to form and apply a trained network (neural network). Alternatively or additionally, a logistic regression may be used.

[0023] A system (e.g., a system for determining the eruption status and primary or permanent tooth type) may include: one or more processors; memory coupled to the one or more processors, the memory configured to store computer-program instructions, that, when executed by the one or more processors, implement a computer-implemented method, the computer- implemented method comprising: gather a three-dimensional (3D) model of a patient's teeth including a target tooth; standardize the 3D model of the target tooth; apply a principal component analysis (PCA) of the dental features of the target tooth to obtain PCA features; determine an eruption status and primary or permanent tooth type of the target tooth based on the PCA features; and output the eruption status and primary or permanent tooth type of the target tooth. Any of these systems may include a memory for storing the results (e.g., the labeled 3D model of the teeth). Any of these systems may also include an output (e.g., monitor, printer, transmitter, including wireless transmitter), etc.

[0024] The apparatuses and/or methods described herein may also be performed using one or more set of reference teeth for normalization. For example, the methods described herein may include a method of automatically determining the eruption status and primary or permanent tooth type of a target tooth. The method may include: receiving, in a computing device, a three- dimensional (3D) model of the patient's teeth including the target tooth, determining, in the computing device, tooth shape features of the target tooth from the 3D model of the patient's teeth, determining, in the computing device, tooth shape features of one or more reference teeth from the 3D model of the patient's teeth, normalizing, in the computing device, at least some of the tooth shape features of the target tooth using the tooth shape features of the one or more reference teeth, applying the normalized tooth shape features to a classifier of the computing device, and outputting from the computing device the eruption status and primary or permanent tooth type of the target tooth. [0025] In any of the apparatuses and/or methods described herein automatically determining eruption status may be performed using an apparatus (e.g., computing device) without human control or direction, particularly in the steps of receiving, determining tooth shape features, normalizing, etc. Alternatively or additionally, any of these steps may be performed partially automatically (e.g., semi-autonomously) or manually.

[0026] A computing device may receive a three-dimensional (3D) model of the patient's teeth including the target tooth either directly (e.g., as part of a scanning apparatus or system), or indirectly, including transfer from a previously taken model. The computing device may be a dedicated device or part of a dedicated device (e.g., scanner) or it may be wired or wirelessly connected to a scanning device or a memory storing scanning information. Alternatively or additionally, the computing device may receive the 3D model from a remote (e.g., internet, cloud, etc.) source.

[0027] In any of the apparatuses and/or methods described herein a target tooth may be user- selected. Alternatively or additionally, all of the teeth in a 3D model of the teeth may be selected as targets; the apparatus and methods may sequentially or concurrently determine the eruption status and primary or permanent tooth status for each of the plurality of target teeth (including for all of the teeth).

[0028] In any of the apparatuses and/or methods described herein, an output may be provided that includes outputting one of: primary erupted, partially erupted permanent (including permanent un-erupted, referred to generically herein as permanent partially erupted/un-erupted), and permanent erupted. Outputting may include fabricating an orthodontic and/or dental appliance based on the determined tooth status (e.g., primary erupted, permanent partially erupted or un-erupted, and permanent erupted). A predicted spacing may be performed based on the primary erupted, permanent partially erupted or un-erupted, and permanent erupted status determined. This spacing may be determined based on the existing and adjacent tooth models (the 3D model) and/or empirical tooth information from the specific patient or a similar patient population. The eruption status information and/or spacing may be used to determine a model (3D model, including digital and non-digital models, such a physical models) that may be fabricated and/or used in the fabrication of a dental and/or orthodontic device.

[0029] The methods described herein may also include taking the 3D model of the patient's teeth. The 3D model may be received from a three-dimensional scanner. Alternatively or additionally, the 3D model may be received from a mold of the patient's teeth.

[0030] The methods described herein may include getting patient information, wherein the patient information includes one or more of: patient age, eruption sequence, measured space available for eruption, and patient gender; further wherein applying the normalized tooth shape features to the classifier comprises applying the patient information to the classifier with the normalized tooth shape features.

[0031] Determining the tooth shape features of the target tooth may comprise determining one or more of: mesial-distal width, buccal-lingual width, crown height, crown center, and number of cusps. Determining the number of cusps can comprise determining the number of cusps in one or more of the arch direction surfaces including: buccal-mesial, buccal-distal, lingual-mesial, and lingual-distal.

[0032] Determining the tooth shape features of one or more reference teeth may comprise determining the tooth shape features of one reference tooth. The one or more reference teeth may comprise a molar. Determining the tooth shape features of one or more reference teeth may comprise determining the tooth shape features of two reference teeth. Any appropriate tooth shape feature (morphological feature(s)) may be determined. For example, determining the tooth shape features of one or more reference teeth may comprise determining, for each of the one or more reference teeth, one or more of: mesial-distal width, buccal-lingual width and crown center.

[0033] Normalizing at least some of the tooth shape features of the target tooth using the tooth shape features of the one or more reference teeth may comprise normalizing one or more of the mesial-distal width, buccal-lingual width, crown height, and crown center to the one or more reference teeth. Normalizing may further comprise determining a total number of cusps in each of the arch direction surfaces including: buccal-mesial, buccal-distal, lingual-mesial, and lingual- distal.

[0034] Any of these methods may also include applying the normalized tooth shape features to the classifier comprises applying either a first level binary classifier or a first level binary classifier and a second level binary classifier to the normalized tooth shape features. Applying the normalized tooth shape features to the classifier may comprise applying a first level binary classifier to a first subset of the normalized tooth shape features and either indicating the eruption status and primary or permanent tooth type of the target tooth based on the first level binary classifier or applying a second level binary classifier to a second subset of the normalized tooth shape features and indicating the eruption status and primary or permanent tooth type of the target tooth based on the second level binary classifier.

[0035] Any of these methods can further comprise outputting the eruption status comprises outputting an indication of a percentage of eruption.

[0036] Any of the methods of automatically determining the eruption status and primary or permanent tooth type of a target tooth may include: receiving, in a computing device, a three- dimensional (3D) model of the patient's teeth including the target tooth, determining, in the computing device, tooth shape features of the target tooth from the 3D model of the patient's teeth, determining, in the computing device, tooth shape features of one or more reference teeth from the 3D model of the patient's teeth, normalizing, in the computing device, at least some of the tooth shape features of the target tooth using the tooth shape features of the one or more reference teeth, applying the normalized tooth shape features to a classifier of the computing device, wherein applying the normalized tooth shape features to the classifier comprises applying a first level binary classifier and, depending on an output of the first level binary classifier, either outputting the eruption status and primary or permanent tooth type of the target tooth, or applying a second level binary classifier to the normalized tooth shape features and then outputting the eruption status and primary or permanent tooth type of the target tooth.

[0037] A method of automatically determining the eruption status and primary or permanent tooth type of a target tooth may include: receiving a three-dimensional model of the patient's teeth including the target tooth, normalizing at least one dimension of the target tooth based on one or more reference teeth, inputting into a first binary classifier tooth shape features including the at least one dimension to determine if the target tooth is a fully erupted permanent tooth, inputting into a second binary classifier the tooth shape features if the first binary classifier determines that the target tooth is not a fully erupted permanent tooth, to determine if the target tooth is a permanent partially erupted/un-erupted tooth or a primary tooth, and outputting that the target tooth is a fully erupted permanent tooth, a permanent partially erupted/un-erupted tooth, or a primary tooth.

[0038] Also described herein are apparatuses for performing any of the methods described herein (including software, firmware and/or hardware configured to control the apparatus to perform and/or coordinate the performance of these methods). For example, described herein are non-transitory computing device readable medium having instructions stored thereon for determining the status of a patient's target tooth. The instructions may be executable by a processor to cause a computing device to receive a three-dimensional (3D) model of the patient's teeth including the target tooth, determine tooth shape features of the target tooth from the 3D model of the patient' s teeth, determine tooth shape features of one or more reference teeth from the 3D model of the patient's teeth, normalize at least some of the tooth shape features of the target tooth using the tooth shape features of the one or more reference teeth, apply the normalized tooth shape features to a classifier of the computing device; and output the eruption status and primary or permanent tooth type of the target tooth.

[0039] The instructions may be further configured so that the output is one of: primary erupted, permanent partially erupted or un-erupted, and permanent erupted.

[0040] The instructions may be further configured to receive the 3D model from a three- dimensional scanner. The instructions may be configured to get patient information, wherein the patient information includes one or more of: patient age, eruption sequence, measured space available for eruption, and patient gender; further wherein the instructions are configured to include the patient information with the normalized tooth shape features applied to the classifier.

[0041] The instructions may be further configured to determine as part of the tooth shape features one or more of: mesial-distal width, buccal-lingual width, crown height, crown center, and number of cusps.

[0042] In any of these apparatuses, the instructions may be further configured to determine the number of cusps by determining the number of cusps in one or more of the arch direction surfaces including: buccal-mesial, buccal-distal, lingual-mesial, and lingual-distal.

[0043] The instructions may be configured to determine the tooth shape features of the one or more reference teeth from one reference tooth. The one reference tooth may comprise a molar.

[0044] The instructions may be configured to determine the tooth shape features of the one or more reference teeth from two reference teeth.

[0045] The instructions may be further configured to determine the tooth shape features of the one or more reference teeth for one or more of: mesial-distal width, buccal-lingual width and crown center.

[0046] The instructions may be further configured to normalize the at least some of the tooth shape features of the target tooth using the tooth shape features of the one or more reference teeth by normalizing one or more of the mesial-distal width, buccal-lingual width, crown height, and crown center to the one or more reference teeth.

[0047] The instructions may be further configured to normalize the at least some of the tooth shape features of the target tooth by determining a total number of cusps in each of the arch direction surfaces including: buccal-mesial, buccal-distal, lingual-mesial, and lingual-distal.

[0048] The instructions may be further configured to apply the normalized tooth shape features to the classifier by applying either a first level binary classifier or a first level binary classifier and a second level binary classifier to the normalized tooth shape features.

[0049] The instructions may be further configured to apply a first level binary classifier to a first subset of the normalized tooth shape features and either indicate the eruption status and primary or permanent tooth type of the target tooth based on the first level binary classifier or to apply a second level binary classifier to a second subset of the normalized tooth shape features and indicate the eruption status and primary or permanent tooth type of the target tooth based on the second level binary classifier. [0050] In any of the apparatuses described herein, the instructions may be further configured to output an indication of a percentage of eruption. In general, the output may be visual and/or digital and/or printed. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] The novel features of the invention are set forth with particularity in the claims that follow. A better understanding of the features and advantages of the present invention will be obtained by reference to the following detailed description that sets forth illustrative

embodiments, in which the principles of the invention are utilized, and the accompanying drawings of which:

[0052] FIG. 1A is a diagram showing an example of a computing environment configured to digitally scan a dental arch and determine a tooth type and/or eruption status of a target tooth.

[0053] FIG. IB is a diagram showing an example of segmentation engine(s).

[0054] FIG. 1C is a diagram showing an example of a feature extraction engine(s).

[0055] FIG. ID is a diagram showing another example of a feature extraction engine(s).

[0056] FIG. IE is a diagram showing an example of detector engine(s).

[0057] FIG. IF is an example of a method of automatically determining the eruption status and/or tooth type of a target tooth.

[0058] FIG. 2A is an example of a method of automatically determining the eruption status and tooth type of a target tooth.

[0059] FIG. 2B is an example of a method of automatically determining the eruption status and tooth type of a target tooth.

[0060] FIGS. 2C-2D are flowcharts describing a detector that uses first and second binary classifiers to determine an eruption status and tooth type of a target tooth. The detector receives normalized features of a target tooth to determine the eruption status and tooth type.

[0061] FIG. 3A is a flowchart describing a method of extracting and generating data to be passed into a tooth status classification detector.

[0062] FIG. 3B is a flowchart describing a tooth status classification detector used to determine the eruption status and tooth type of a target tooth with the data from the flowchart of FIG. 3A.

[0063] FIG. 3C is a flowchart describing a classifier of the tooth status classification detector that determines an eruption status and tooth type of a target tooth.

[0064] FIG. 4 shows a distribution of mesial-distal width for Tooth 4.

[0065] FIG. 5A shows a distribution of crown height for Tooth 6.

[0066] FIG. 5B shows a distribution of buccal-lingual width for Tooth 6. [0067] FIG. 6 shows a distribution of crown height for Tooth 5.

[0068] FIG. 7 shows examples of tooth shape by detention type and eruption status, including 1) Permanent, Fully Erupted, 2) Permanent, Partially Erupted, and 3) Primary.

[0069] FIG. 8 is a simplified block diagram of a data processing system that may perform methods described herein.

DETAILED DESCRIPTION

[0070] Described herein are apparatuses (e.g., systems, computing device readable media, devices, etc.) and methods for detecting eruption state (e.g., eruption status and tooth type) of a target tooth. Currently, some of the most often heard clinical barriers for teen utilization of orthodontic aligners are the challenges due to un-erupted or erupting teeth. One object of the present disclosure is to use machine learning technology to provide an automatic detector that can distinguish between three tooth type/eruption status for premolars and canines: 1) permanent partially erupted/un-erupted tooth, 2) fully erupted permanent tooth, or 3) fully erupted primary tooth. The detector can make this determination based upon data including patient

demographics, tooth measurements, tooth surface mesh, and historical patient data. These methods and apparatus can use this information to provide output to a patient, physician, dental technician, or the like. These apparatuses and/or methods may be further configured to use the determined tooth type and eruption status in forming one or more orthodontic devices (e.g., one or more, including a set, of aligners), treatment plans, or some combination of these.

[0071] For example, described herein are apparatuses and/or methods, e.g., systems, including systems to automatically implement processes that incorporate an automatic tooth detector. When the system is triggered by a detection request for a certain tooth, the system can retrieve relevant tooth/patient information from a local or remote database, process the information, and convert the information into representative features. The features can then be passed into an eruption status and tooth type detector, which may use machine learning technology (e.g., Decision Tree, Random Forest, Logistic Regression, Support Vector Machine, AdaBOOST, K-Nearest Neighbor (KNN), Quadratic Discriminant Analysis, Neural Network, etc.) to return a target tooth status classification identifying the eruption status and tooth type of the target tooth. The parameters inputted into the eruption status and tooth type detector can be optimized with historic data. The eruption status and tooth detector may be used to determine the eruption status and permanent/primary tooth type identification on a single tooth (e.g., a single target tooth) or one all of the teeth (or a subset of teeth) in a digital representation of the patient's dental arch. The results may be provided on demand and/or may be stored in a memory (e.g., database) for later use. In some variations the results may be used to modify the labels associated with each tooth reflective of the results (e.g., reflecting the eruption status, such as erupted, partially erupted, un-erupted, and/or primary/permanent status of the teeth).

[0072] The apparatuses and/or methods described herein may be useful in planning and fabrication of dental appliances, including elastic polymeric positioning appliances, is described in detail in U.S. Pat. No. 5,975,893, and in published PCT application WO 98/58596, which is herein incorporated by reference for all purposes. Systems of dental appliances employing technology described in U.S. Pat. No. 5,975,893 are commercially available from Align

Technology, Inc., Santa Clara, Calif., under the tradename, Invisalign System.

[0073] Throughout the body of the Description of Embodiments, the use of the terms "orthodontic aligner", "aligner", or "dental aligner" is synonymous with the use of the terms "appliance" and "dental appliance" in terms of dental applications. For purposes of clarity, embodiments are hereinafter described within the context of the use and application of appliances, and more specifically "dental appliances."

[0074] The apparatuses and/or methods (e.g., systems, devices, etc.) described below can be used with and/or integrated into an orthodontic treatment plan. The apparatuses and/or methods described herein may be used to segment a patient's teeth from a two-dimensional image and this segmentation information may be used to simulate, modify and/or choose between various orthodontic treatment plans. Segmenting the patient's teeth can be done automatically (e.g., using a computing device). For example, segmentation can be performed by a computing system automatically by evaluating data (such as three-dimensional scan, or a dental impression) of the patient's teeth or arch.

[0075] As described herein, an intraoral scanner may image a patient's dental arch and generate a virtual three-dimensional model of that dental arch. During an intraoral scan procedure (also referred to as a scan session), a user (e.g., a dental practitioner) of an intraoral scanner may generate multiple different images (also referred to as scans or medical images) of a dental site, model of a dental site, or other object. The images may be discrete images (e.g., point- and- shoot images) or frames from a video (e.g., a continuous scan). The three-dimensional scan can generate a 3D mesh of points representing the patient's arch, including the patient's teeth and gums. Further computer processing can segment or separate the 3D mesh of points into individual teeth and gums.

[0076] An automated tooth detection system, as used herein, may include a system that uses automated agents to identify and/or number individual teeth and/or dental features of virtual representations of teeth, such as teeth represented in a three-dimensional dental mesh model resulting from a digital scan. [0077] The present disclosure presents one or more novel processes for identifying and segmenting a patient's teeth during an identification process. Some implementations herein may solve technical problems related to optimizing and/or increasing the accuracy of digital dental scanning technologies. The tooth detection processes described herein advantageously may: provide fully automatic tooth detection with no human intervention needed; compensate for errors generated by machine learning detectors; quickly and efficiently identify teeth types and/or eruption status; and/or implement any machine learning detectors.

[0078] FIG. 1A is a diagram showing an example of a computing environment 100A configured to facilitate gathering digital scans of a dental arch with teeth therein. The environment 100A includes a computer-readable medium 152, a scanning system 154, a dentition display system 156, and a 3D mesh processing system 158. One or more of the modules in the computing environment 100A may be coupled to one another or to modules not explicitly shown.

[0079] The computer-readable medium 152 and other computer readable media discussed herein are intended to represent a variety of potentially applicable technologies. For example, the computer-readable medium 152 can be used to form a network or part of a network. Where two components are co-located on a device, the computer-readable medium 152 can include a bus or other data conduit or plane. Where a first component is co-located on one device and a second component is located on a different device, the computer-readable medium 152 can include a wireless or wired back-end network or LAN. The computer-readable medium 152 can also encompass a relevant portion of a WAN or other network, if applicable.

[0080] The scanning system 154 may include a computer system configured to scan a patient's dental arch. A "dental arch," as used herein, may include at least a portion of a patient' s dentition formed by the patient' s maxillary and/or mandibular teeth, when viewed from an occlusal perspective. A dental arch may include one or more maxillary or mandibular teeth of a patient, such as all teeth on the maxilla or mandible or a patient. The scanning system 154 may include memory, one or more processors, and/or sensors to detect contours on a patient's dental arch. The scanning system 154 may be implemented as a camera, an intraoral scanner, an x-ray device, an infrared device, etc. The scanning system 154 may include a system configured to provide a virtual representation of a physical mold of patient's dental arch. The scanning system 154 may be used as part of an orthodontic treatment plan. In some implementations, the scanning system 154 is configured to capture a patient's dental arch at a beginning stage, an intermediate stage, etc. of an orthodontic treatment plan.

[0081] The dentition display system 156 may include a computer system configured to display at least a portion of a dentition of a patient. The dentition display system 154 may include memory, one or more processors, and a display device to display the patient's dentition.

The dentition display system 156 may be implemented as part of a computer system, a display of a dedicated intraoral scanner, etc. In some implementations, the dentition display system 156 facilitates display of a patient's dentition using scans that are taken at an earlier date and/or at a remote location. It is noted the dentition display system 156 may facilitate display of scans taken contemporaneously and/or locally to it as well. As noted herein, the dentition display system 156 may be configured to display the intended or actual results of an orthodontic treatment plan applied to a dental arch scanned by the scanning system 154. The results may include 3D virtual representations of the dental arch, 2D images or renditions of the dental arch, etc.

[0082] The 3D mesh processing system 158 may include a computer system configured to process 3D scans or meshes of a patient's dentition taken by the scanning system 154. As noted herein, the 3D mesh processing system 158 may be configured to process scans of teeth in a dental arch. The 3D mesh processing system 158 may include segmentation engine(s) 160, feature extraction engine(s) 162, and detector engine(s) 164. One or more of the modules of the image processing system 158 may be coupled to each other or to modules not shown.

[0083] As used herein, any "engine" may include one or more processors or a portion thereof. A portion of one or more processors can include some portion of hardware less than all of the hardware comprising any given one or more processors, such as a subset of registers, the portion of the processor dedicated to one or more threads of a multi-threaded processor, a time slice during which the processor is wholly or partially dedicated to carrying out part of the engine's functionality, or the like. As such, a first engine and a second engine can have one or more dedicated processors or a first engine and a second engine can share one or more processors with one another or other engines. Depending upon implementation- specific or other considerations, an engine can be centralized or its functionality distributed. An engine can include hardware, firmware, or software embodied in a computer-readable medium for execution by the processor. The processor transforms data into new data using implemented data structures and methods, such as is described with reference to the figures herein.

[0084] The engines described herein, or the engines through which the systems and devices described herein can be implemented, can be cloud-based engines. As used herein, a cloud- based engine is an engine that can run applications and/or functionalities using a cloud-based computing system. All or portions of the applications and/or functionalities can be distributed across multiple computing devices, and need not be restricted to only one computing device. In some embodiments, the cloud-based engines can execute functionalities and/or modules that end users access through a web browser or container application without having the functionalities and/or modules installed locally on the end-users' computing devices. [0085] As used herein, "datastores" may include repositories having any applicable organization of data, including tables, comma- separated values (CSV) files, traditional databases (e.g., SQL), or other applicable known or convenient organizational formats. Datastores can be implemented, for example, as software embodied in a physical computer-readable medium on a specific-purpose machine, in firmware, in hardware, in a combination thereof, or in an applicable known or convenient device or system. Datastore-associated components, such as database interfaces, can be considered "part of" a datastore, part of some other system component, or a combination thereof, though the physical location and other characteristics of datastore- associated components is not critical for an understanding of the techniques described herein.

[0086] Datastores can include data structures. As used herein, a data structure is associated with a particular way of storing and organizing data in a computer so that it can be used efficiently within a given context. Data structures are generally based on the ability of a computer to fetch and store data at any place in its memory, specified by an address, a bit string that can be itself stored in memory and manipulated by the program. Thus, some data structures are based on computing the addresses of data items with arithmetic operations; while other data structures are based on storing addresses of data items within the structure itself. Many data structures use both principles, sometimes combined in non-trivial ways. The implementation of a data structure usually entails writing a set of procedures that create and manipulate instances of that structure. The datastores, described herein, can be cloud-based datastores. A cloud-based datastore is a datastore that is compatible with cloud-based computing systems and engines.

[0087] The segmentation engine(s) 160 may be configured to implement one or more automated agents configured to process tooth scans from the scanning system 154. The segmentation engine(s) 160 may include graphics engines to process images or scans of a dental arch. In some implementations, the segmentation engine(s) 160 format scan data from an scan of a dental arch into a dental mesh model (e.g., a 3D dental mesh model) of the dental arch. The segmentation engine(s) 160 may also be configured to segment the 3D dental mesh model of the dental arch into individual dental components, including segmenting the 3D dental mesh model into 3D mesh models of individual teeth. The 3D dental mesh models of the dental arch and/or the individual teeth may comprise geometric point clouds or polyhedral objects that depict teeth and/or other elements of the dental arch in a format that can be rendered on the dentition display system 156. The segmentation engine(s) 160 may provide 3D dental mesh models and/or other data to other modules of the 3D mesh processing system 158.

[0088] The feature extraction engine(s) 162 may implement one or more automated agents configured to extract dental features. A "dental feature," as used herein, may include data points from the 3D dental mesh model that correlate to edges, contours, vertices, vectors, or surfaces of the patient's teeth. A "dental feature" may be based on patient demographics and/or tooth measurements. A dental feature may be related to "PCA features," e.g., those dental features derived from a principal component analysis of a tooth. In some implementations, the feature extraction engine(s) 162 is configured to analyze 3D dental mesh models from the segmentation engine(s) 160 to extract the dental features. The feature extraction engine(s) 162 may implement principal component analysis (PCA) to obtain the dental features. In one implementation, the 3D dental mesh model of individual teeth comprises a scatter plot of points representing a patient's tooth, and PCA can be applied to the scatter plot to obtain vectors along the biggest distribution of scatter plots. The feature extraction engine(s) can then project from the center of the scatter plot to find vectors that intersect the tooth shape at each angle.

[0089] The detector engine(s) 164 may implement one or more automated agents configured to predict tooth state (e.g., tooth type and/or eruption status) of a target tooth using extracted dental features. In some implementations, the detector engine(s) 164 assign physical and/or geometrical properties to a 3D dental mesh model that are related to physical/geometrical properties of dental arches or teeth. The detector engine(s) 164 may receive dental features from the feature extraction engine(s) 162 and apply machine learning algorithms to predict tooth type and/or eruption status of a target tooth using extracted dental features. In some implementations, the detector engine(s) 164 use a trained convolutional neural network and/or trained classifiers to classify a target tooth into one or more identified categories of teeth type, eruption status, tooth number, etc. Examples of machine learning systems implemented by the detector engine(s) 164 may include Decision Tree, Random Forest, Logistic Regression, Support Vector Machine, AdaBOOST, K-Nearest Neighbor (KNN), Quadratic Discriminant Analysis, Neural Network, etc., to determine a tooth type (e.g., incisor, canine, pre-molar, molar, etc.), eruption status (e.g., permanent, permanent erupting, primary), and/or tooth number of the target tooth. The detector engine(s) 164 can incorporate predicted tooth type and/or eruption status into a final

segmentation result. The detector engine(s) 164 may also output a final segmentation result to other modules, for example, the optional treatment modeling engine(s) 166. As an example, the detector engine(s) 164 may implement one or more automated segmentation agents that assign tooth identifiers (e.g., universal tooth numbers, tooth type, or eruption status) to specific portions of a 3D dental mesh model.

[0090] The optional treatment modeling engine(s) 166 may be configured to store and/or provide instructions to implement orthodontic treatment plans and/or the results of orthodontic treatment plans. The optional treatment modeling engine(s) 166 may provide the results of orthodontic treatment plans on a 3D dental mesh model. The optional treatment modeling engine(s) 166 may model the results of application of orthodontic aligners to the patient's dental arch over the course of an orthodontic treatment plan.

[0091] FIG. IB is a diagram showing an example of the segmentation engine(s) 160a. The segmentation engine(s) 160a may include an arch scanning engine 168 and an individual tooth segmentation datastore 170. One or more of the modules of the segmentation engine(s) 160a may be coupled to each other or to modules not shown.

[0092] The arch scanning engine 168 may implement one or more automated agents configured to scan a 3D dental mesh model for individual tooth segmentation data. "Individual tooth segmentation data," as used herein, may include positions, geometrical properties

(contours, etc.), and/or other data that can form the basis of segmenting individual teeth from 3D dental mesh models of a patient's dental arch. The arch scanning engine 168 may implement automated agents to separate dental mesh data for individual teeth from a 3D dental mesh model of the dental arch. The arch scanning engine 168 may further implement automated agents to number the individual teeth.

[0093] The individual tooth segmentation datastore 170 may be configured to store data related to model dental arches, including model dental arches that have been segmented into individual teeth. The model dental arch data may comprise data related to segmented individual teeth, including tooth identifiers of the individual teeth such as tooth types, tooth numbers, and eruption status(es).

[0094] FIG. 1C is a diagram showing an example of the feature extraction engine(s) 162a. The feature extraction engine(s) 162a may include principal component analysis engine 172, a center projection engine 174, and a tooth feature datastore 170. One or more of the modules of the feature extraction engine(s) 162a may be coupled to each other or to modules not shown.

[0095] The principal component analysis engine 172 may implement one or more automated agents configured to apply PCA to the individual tooth segmentation data. The principal component analysis engine 172 may implement one or more automated agents configured to apply PCA to the individual tooth segmentation data to obtain vectors along the biggest distribution of scatter plots. These vectors may represent a point in 3D space where the vectors intersect the tooth shape. The principal component analysis engine 172 may obtain, for example, a limited or specific number of vectors at known angles in 3D space (e.g., 2500 known angles from the 3D mesh model). The principal component analysis engine 172 can communicate the vector data to the center projection engine 174 and to the tooth feature datastore 176.

[0096] The center projection engine 174 may implement one or more automated agents configured to find the appropriate center of the individual tooth segmentation data. The center projection engine 174 may, for example, apply various techniques such as geometric center, weighted center, etc., to find the center of the individual tooth segmentation data. The center projection engine 174 can store the center data in the tooth feature datastore 176.

[0097] The tooth feature datastore 176 may be configured to store data related to teeth features, including vectors representing the tooth shape and center data representing the center of the individual tooth segmentation data. In some implementations, only a subset of the total tooth features, such as the vectors representing tooth shape, are stored in the tooth feature datastore.

[0098] FIG. ID is a diagram showing an alternative example of a feature extraction engine(s) 162b. The feature extraction engine(s) 162b may include tooth comparison engine 178, normalization engine 180, and a tooth feature datastore 184. One or more of the modules of the feature extraction engine(s) 162a may be coupled to each other or to modules not shown.

[0099] The tooth comparison engine 178 may implement one or more automated agents configured to determine tooth shape features from the individual tooth segmentation data. The tooth shape features may comprise, for example, length and/or width of the target tooth, such as mesial-distal width, buccal-lingual width, and crown height, and may additionally include the crown center of the target tooth or the number of cusps of the target tooth. The tooth comparison engine 178 may implement one or more automated agents configured to compare the tooth shape features to one or more reference teeth. The tooth comparison engine 178 can communicate the tooth shape features and comparison data to the tooth feature datastore 182.

[0100] The normalization engine 180 may implement one or more automated agents configured to normalize the tooth shape features of the individual tooth segmentation data by taking into consideration individual heterogeneity in tooth size. The normalization engine 180 can communicate the normalization data to the tooth feature datastore 182.

[0101] The tooth feature datastore 182 may be configured to store data related to tooth shape features and normalization data from the modules described above.

[0102] FIG. IE is a diagram showing an example of the detector engine(s) 164a. The detector engine(s) 164a may receive teeth features, tooth shape features, or normalization data from either the feature extraction engine(s) 162a or 162b described above. The detector engine(s) 164a may include a machine learning detector engine 184, a tooth type datastore 186, and an eruption status datastore 188.

[0103] The machine learning detector engine 184 may implement one or more automated agents configured to use machine learning techniques to classify a tooth eruption state of a target tooth with extracted dental features associated with the target tooth. In some implementations, the machine learning detector engine 184 may receive dental features such as tooth features, tooth shape features, or normalization data from the feature extraction engine(s) 162a or 162b. Using a trained classifier, the machine learning detector engine 184 may provide an identifier (e.g., a statistical or other score) that associates the target tooth with a specified category of tooth. As examples, the machine learning detector engine 184 may use a classifier trained to correlate various dental features with whether a tooth is a partially erupted permanent tooth, a fully erupted permanent tooth, or a fully erupted primary tooth. The machine learning detector engine 184 may use a classifier trained to correlate various dental features with tooth type(s)

(e.g., incisor, canine, pre-molar, molar, etc.), eruption status(es) (permanent, permanent erupting, primary), and/or tooth number(s). The machine learning detector engine 184 may incorporate one or more machine learning techniques. Examples of such techniques include Decision Tree, Random Forest, Logistic Regression, Support Vector Machine, AdaBOOST, K- Nearest

Neighbor (KNN), Quadratic Discriminant Analysis, Neural Network, etc...

[0104] The tooth type datastore 186 may be configured to store data relating dental features to tooth type(s) (e.g., incisor, canine, pre-molar, molar, etc., and/or a tooth number(s) (e.g., a universal tooth number). In some implementations, the data relating dental features to tooth type(s) and/or tooth number(s) may have been stored by the machine learning detector engine 184 during a training phase. The eruption status datastore 188 may be configured to store data relating dental features eruption status(es) (e.g., permanent, permanent erupting, primary). In some implementations, the data relating dental features to eruption status(es) may have been stored by the machine learning detector engine 184 during a training phase.

[0105] FIG. IF illustrates one example of a method for automatically determining the eruption state (e.g., eruption status and/or primary /permanent tooth type) for one or more teeth of a patient's dental arch. This method may be automatically implemented by a system, such as one or more of the systems in the computing environment 100A, shown in FIG. 1A. At an operation 190, the system may automatically collect a three-dimensional (3D) scan of the patient's dental arch. The 3D scan may be collected directly from the patient (e.g., using an intraoral scanner) or indirectly (e.g., by scanning a mold of the patient's dentition and/or be receiving a digital model of the patient taken by another, etc.). Optionally, at an operation 191, additional information about the patient may be collected (directly or indirectly), such as the patient's age, gender, etc.

[0106] The 3D scan may be prepared for further processing. For example, the 3D scan may be expressed as a digital mesh and/or segmented into individual teeth (and non-teeth elements, such as gingiva, arch, etc.). At an operation 192, the 3D scan may be standardized and/or normalized. For example, in some variations the 3D model may be standardized by expressing each tooth as a set of vectors from a center point of that tooth to a surface point on the tooth. The number and order of the vectors may be preset. For example, over x angles (e.g., over 1000 angles, over 1500 angles, over 2000 angles, over 2500 angles, etc.) may be taken in three dimensional space for each tooth. Alternatively or additionally, as will be described below, the teeth or features extracted from the teeth, may be normalized using database of reference teeth.

[0107] At an operation 193, dental features may be extracted from the

standardized/normalized 3D model of the patient's teeth (and in some variations from additional data about the patient or the patient's teeth), e.g., using a feature extraction engine. For example, in some variations extraction of features may include automatically performing principle component analysis (PCA) on the teeth (e.g., on each segmented tooth) and the resulting first n terms of the PCA may be used as extracted features (e.g., where n is 10 or more, 15 or more, 20 or more, 30 or more, 40 or more, 50 or more, 60 or more, 70 or more, etc.). Although

standardization and normalization are shown together in FIG. IF (see operation 192) and shown before an operation of feature extraction (see operation 193), in some variations, the operation of normalization (e.g., operation 192) may be performed separately and/or concurrently or after extracting tooth features (e.g., operation 193).

[0108] At an operation 194, extracted dental features (e.g., extracted PCA features) may be used exclusively or in combination with any other extracted feature described herein. The extracted dental features may be provided to the detector engine to determine the primary or permanent tooth type and/or eruption status (un-erupted, partially erupted, erupted) for one or more of the patient's teeth 194.

[0109] At an operation 195, the eruption state (e.g., primary/permanent tooth type and/or eruption status) for the one or more teeth of the patient's dental arch may then be output. In some variations this information is used to modify a model (e.g., a 3D digital model) of the patient's teeth (e.g., dental arch). For example, each tooth may be labeled and/or referenced by a name or number (or other alphanumeric) that corresponds to the tooth eruption status and/or primary/permanent tooth type. For example, the tooth may be automatically and accurately labeled using these methods and systems in a numbering standard (e.g., a universal number system or a modified universal numbering system) that further indicates primary/permanent teeth. For example, uppercase letters A through T may be used for primary teeth and the numbers 1 - 32 may be used for permanent teeth, as would be understood by those of skill in the dental/orthodontic art. Alternative standard dental numbering systems may be used (e.g., FDI World Dental Federation notation, Palmer notation, etc.).

[0110] FIG. 2A shows an example of a flowchart describing a method of automatically determining the eruption status and tooth type of a target tooth of a patient with a detection system. At step 200 of the flowchart in FIG. 2A, a three-dimensional (3D) model of the patient's teeth can be collected. The 3D models may include surface features or surface features and internal features. In some embodiments, the 3D model can be generated with an intraoral scanner that can be hand-held by an operator (e.g., dentist, dental hygienist, technician, etc.) and moved over a patient's tooth or teeth to scan both surface and (optionally) internal structures. In general, any appropriate technique may be used to form the 3D models of the tooth including the surface and internal structures from the intraoral scanner. In another embodiment, the 3D model can be generated from a mold of the patient' s teeth.

[0111] At step 202 of the flowchart of FIG. 2A, patient info can be (optionally) acquired, such as the patient's age, gender, eruption sequence, measured space available for eruption, etc.

Age, eruption sequence, and gender can be useful as supporting factors for prediction. For example, if the patient's 1 ^st bicuspid (tooth 4) is erupting earlier than the canine in the upper jaw (tooth 3) or the 2 ^nd bicuspid in the upper jaw (tooth 5), then historical eruption sequence data indicates that both teeth 3 and 5 are likely to be primary teeth. Similarly, if tooth 3 is erupting, tooth 4 is likely to be fully erupted, especially for males. This information, if acquired, can be later used by the detection system to aid in determining the eruption status and tooth type of the target tooth. The eruption sequence is not always the same, however it may provide another factor for consideration as described herein. For example, a typical eruption sequence for the upper teeth may be: 6 - 1 - 2 - 4 - 5 - 3 - 7 - 8, or 6 - 1 - 2 - 4 - 3- 5 - 7 - 8. A typical eruption sequence for the lower teeth may be: 6 - 1 - 2 - 3 - 4 - 5 - 7 - 8.

[0112] At step 204 of the flowchart of FIG. 2A, the 3D model of each tooth may be standardized. The detection system can obtain 3D mesh data for each individual tooth from the patient's arch. In some examples, the detection system can implement automated agents to scan and segment the 3D model data of the patient's arch from step 200 into 3D model data of the individual teeth. The 3D model data of the individual teeth can include surface features or surface features and internal features representing the shape of each tooth.

[0113] At step 206 of the flowchart of FIG. 2A, a PCA of the standardized 3D model for each tooth may be taken in order to obtain PCA features for the tooth. In some implementations, the detection system can receive or determine tooth or dental features for a target tooth of the patient. These tooth or dental features may include data points from the 3D dental mesh model that correlate to edges, contours, vertices, vectors, or surfaces of the patient's teeth. In one embodiment, the tooth or dental features can be received or determined from the 3D model of the patient's teeth or individual teeth, or alternatively from a clinical evaluation of the patient.

[0114] At step 208 of the flowchart of FIG. 2B, the dental features from step 206 to determine the tooth type (e.g., if the target tooth is a primary tooth or a permanent tooth), the tooth number (e.g., the universal tooth number), and/or the eruption status (e.g., if the target tooth is fully erupted or partially erupted). This can be achieved by passing the tooth or dental features and optional patient info (e.g., patient age/gender, eruption sequence, measured space available for eruption) to a machine learning detector. The machine learning detector can apply machine learning algorithms, including Decision Tree, Random Forest, Logistic Regression, Support Vector Machine, AdaBOOST, K-Nearest Neighbor (KNN), Quadratic Discriminant Analysis, Neural Network, etc., to determine a tooth type (e.g., incisor, canine, pre-molar, molar, etc.), eruption status (permanent, permanent erupting, primary), and/or tooth number of the target tooth by comparing the dental or tooth features and optional patient data to reference dental or tooth features (while accounting for optional patient data).

[0115] At step 210 of the flowchart of FIG. 2A, the detection system can receive the tooth type and eruption status , and can output the target tooth type and eruption status. The output can comprise 1) primary tooth type and fully erupted, 2) permanent tooth type and un- erupted/erupting, or 3) permanent tooth type and fully erupted. The output can optionally include the eruption percentage, etc.

[0116] FIG. 2B is a flowchart describing a method of automatically determining the eruption status and tooth type of a target tooth of a patient with a detection system. At step 201 of FIG. 1A, a three-dimensional (3D) model of the patient's teeth can be (optionally) taken. The 3D models may include surface features or surface features and internal features. In some embodiments, the 3D model can be generated with an intraoral scanner that can be hand-held by an operator (e.g., dentist, dental hygienist, technician, etc.) and moved over a patient's tooth or teeth to scan both surface and (optionally) internal structures. In general, any appropriate technique may be used to form the 3D models of the tooth including the surface and internal structures from the intraoral scanner. In another embodiment, the 3D model can be generated from a mold of the patient's teeth.

[0117] At step 203 of FIG. 2B, patient info can be (optionally) acquired, such as the patient's age, gender, eruption sequence, measured space available for eruption, etc. Age, eruption sequence, and gender can be useful as supporting factors for prediction. For example, if the patient's 1 ^st bicuspid (tooth 4) is erupting earlier than the canine in the upper jaw (tooth 3) or the 2 ^nd bicuspid in the upper jaw (tooth 5), then historical eruption sequence data indicates that both teeth 3 and 5 are likely to be primary teeth. Similarly, if tooth 3 is erupting, tooth 4 is likely to be fully erupted, especially for males. This information, if acquired, can be later used by the detection system to aid in determining the eruption status and tooth type of the target tooth. The eruption sequence is not always the same, however it may provide another factor for

consideration as described herein. For example, a typical eruption sequence for the upper teeth may be: 6 - 1 - 2 - 4 - 5 - 3 - 7 - 8, or 6 - 1 - 2 - 4 - 3- 5 - 7 - 8. A typical eruption sequence for the lower teeth may be: 6 - 1 - 2 - 3 - 4 - 5 - 7 - 8. [0118] At step 205 of FIG. 2B, the detection system can receive or determine features of tooth shape for a target tooth of the patient. These tooth shape features can include, for example, length and/or width of the target tooth, such as mesial-distal width, buccal-lingual width, and crown height; crown center of the target tooth; and number of cusps of the target tooth, such as buccal-mesial, buccal-distal, lingual-mesial, and lingual-distal. In one embodiment, the features of tooth shape can be received or determined from the 3D model of the patient's teeth, or alternatively from a clinical evaluation of the patient.

[0119] At step 207 of FIG. 2B, the detection system can receive or determine features of one or more reference tooth/teeth shape from the patient. The reference tooth/teeth shape features can include, for example, length and/or width of the target tooth/teeth, including mesial-distal width and buccal-lingual width, and can also include crown center of the reference tooth or teeth. In one embodiment, the features of the reference tooth/teeth shape can be received or determined from the 3D model of the patient's teeth, or alternatively from a clinical evaluation of the patient.

Table 1

[0120] Table 1 above lists the variables that can be evaluated by the detection system to determine the eruption status and tooth type of a target tooth i. Table 1 also provides the data source for each variable, e.g., whether the data came from a clinical evaluation or from the 3D model. [0121] At step 209 of FIG. 2B, the features of the target tooth can be normalized to take into consideration individual heterogeneity in tooth size. The normalization of features can include any of the steps 211, 213, or 215 of FIG. 2B. In one embodiment, at step 211, the target tooth can be normalized with respect to the width (e.g., buccal-lingual width or mesial-distal width) of a reference tooth or teeth comprising 1 ^st molars in the same jaw as the target tooth. In another embodiment, at step 213, the target tooth can be normalized with respect to the crown center of a reference tooth or teeth comprising 1 ^st molars in the same jaw as the target tooth, or comprising central incisors in the same jaw as the target tooth. The reference tooth or teeth should be either

1 ^st molars or central incisors, which generally erupt at an early age (6-8 years) and therefore widely available in a typical patient. In another embodiment, at step 215, the total number of cusps of the target tooth can be determined.

[0122] Referring back to step 211, for the buccal-lingual width, the normalized value is: [0123] If either of the two 1 ^st molars is missing, the detection system can use the existing 1 ^st molar to do normalization. If both 1 ^st molars are missing, the value of w _{BL i} can be set as "not a number" (NaN). A similar approach applies to normalizing a value for the mesial-distal width.

[0124] Referring back to step 213, the position of the crown center for the target tooth in the Z direction can be computed relative to a reference tooth or teeth with the following formula:

Z _j = Z _j — Z _j - _g -

[0125] For premolars, the reference tooth can be the 1 ^st molar on the same side of the same jaw, i.e.:

zref ^{= Z} SSM

[0126] While for canines, the reference tooth can be the central incisor on the same side of the same jaw, i.e.:

zref ^{= Z} SSI

[0127] If z _ref is missing, the value of z _£ should be set as NaN.

[0128] Referring back to step 215, the total number of cusps of the target tooth can also be used for eruption status/tooth type detection. The total number of cusps can be computed with:

ni ^{= n} BM,i + ⁿ BD,i + ⁿ LM,i + ⁿ LD,i

[0129] If any of n _{BM i} , n _{BD i} , n _{LM i} , n _{LD i} is missing, its value can be imputed as 0, with one exception: if all of them are missing, the value of should be set as NaN. [0130] At step 217 of FIG. 2B, the detection system can use the normalized features from step 209 to determine the tooth type (e.g., if the target tooth is a primary tooth or a permanent tooth) and the eruption status (e.g., if the target tooth is fully erupted or partially erupted). This can be achieved by passing the normalized features and optional patient info (e.g., patient age/gender, eruption sequence, measured space available for eruption) to a detector as further described in FIGS. 2C and 2D.

[0131] Table 2 provides a list of the normalized features and optional patient info that can be used by the detectors of FIGS. 2C and 2D to return the target tooth status classification. As mentioned above, the level- 1 classifier can use a first set of normalized features and the level-2 classifier can use a second set of normalized features.

Table 2 - list of normalized features and patient info used by detector

[0132] The detectors of FIGS. 2C and 2D can determine a target tooth status classification from three groups, shown below in Table 3. The classification includes information both on the tooth type (permanent vs. primary) as well as the eruption status (partially erupted vs. fully erupted).

Table 3 - classification groups

[0133] The detector (either FIG. 2C or FIG. 2D) used at step 217 depends on the tooth type of the target tooth. Thus, one classification structure is used when the target tooth is a 2 ^nd premolar, and another classification structure is used when the target tooth is a 1 ^st premolar or canine. For 2 ^nd premolars, primary teeth differ from permanent teeth significantly in mesial- distal width (see FIG. 4, for example). However, for canines, fully erupted permanent teeth differ from the other two types of teeth significantly in crown height and buccal-lingual width (see FIGS. 5A-4B, for example). A similar pattern can be observed for crown height for 1 ^st premolars (see FIG. 6, for example). Therefore, if the target tooth comprises a 2 ^nd premolar, then the normalized features and patient info are passed to the detector of FIG. 2C. If the target tooth comprises a 1 ^st premolar or canine, then the normalized features and patient info are passed to the detector of FIG . 2D .

[0134] Finally, at step 219 of FIG. 2B, the detection system can receive the tooth type and eruption status from the detector, and can output the target tooth type and eruption status. The output can comprise 1) primary tooth type and fully erupted, 2) permanent tooth type and un- erupted/erupting, or 3) permanent tooth type and fully erupted. The output can optionally include the eruption percentage, etc.

[0135] FIG. 2C is a flowchart describing a detector that uses first and second binary classifiers to determine an eruption status and tooth type of a target tooth. As described above, the detector of FIG. 2C is used when the target tooth comprises a 2 ^nd premolar. The flowchart of FIG. 2C describes the detector from step 217 of FIG. 2B that is used to determine the target tooth type and eruption status.

[0136] The detector of FIG. 2C uses a hierarchical structure to convert multi-class classification problems into a cascading binary classification problem. The detector uses a level- 1 classifier (at step 151 of FIG. 2C) to address a first (and relatively easier) classification task followed by, if necessary, a level-2 classifier (at step 155 of FIG. 2C) to complete the

classification of the target tooth. The level- 1 classifier can use a first set of normalized features, and optionally patient info, to address the first classification task, and the level 2 classifier can use a second set of normalized features, and optionally patient info, to address the second classification task.

[0137] Referring to step 251 of FIG. 2C, the detector uses a first set of normalized features (and, optionally patient info) in a level- 1 classifier to determine a first binary classification of the target tooth comprising a 2 ^nd premolar. The level- 1 classifier of the detector can implement various machine learning algorithms, including Decision Tree, Random Forest, Logistic

Regression, Support Vector Machine, AdaBOOST, K-Nearest Neighbor (KNN), Quadratic Discriminant Analysis, Neural Network, etc. At step 253, the level-1 classifier can determine if the target tooth is a fully erupted primary tooth based on the first set of normalized features and optionally the patient info. If the level-1 classifier at step 253 determines that the target tooth is a fully erupted primary tooth, then the detector can return the target tooth status classification of "fully erupted primary tooth" at step 261.

[0138] However, if the level-1 classifier determines that the target tooth is not a fully erupted primary tooth, then at step 255 of FIG. 2C, the detector uses a second set of normalized features (and, optionally patient info) in a level-2 classifier to determine a second binary classification of the target tooth. The level-2 classifier of the detector can also implement the same various machine learning algorithms as the level- 1 classifier. At step 257, the level-2 classifier can determine if the target tooth is a fully erupted permanent tooth based on the second set of normalized features and optionally the patient info. If the level-2 classifier at step 257 determines that the target tooth is a fully erupted permanent tooth, then the detector can return the target tooth status classification of "fully erupted permanent tooth" at step 261. If the level-2 classifier determines that the target tooth is not a fully erupted permanent tooth at step 257, then the level-2 classifier determines at step 259 that the target tooth is a permanent partially erupted/un-erupted tooth, and the detector can then return the target tooth status classification of "permanent partially erupted/un-erupted tooth" at step 261.

[0139] Table 4 describes the classifier design when the target tooth comprises a 2 ^nd premolar, including the input (normalized) features, and the output options at each stage of the detector. This classifier design is used for the detector of FIG. 2C.

Table 4 - classifier design when target tooth comprises 2 ^nd premolar

[0140] Thus, according to Table 4, when the target tooth is a 2 premolar, the normalized features used by the level-1 classifier include normalized buccal-lingual width, normalized mesial-distal width, crown height, and total number of cusps. The normalized features used by the level-2 classifier include normalized buccal-lingual width, normalized mesial-distal width, crown height, and relative crown center Z. The level-1 classifier can return a positive output of a fully erupted primary tooth, and the level-2 classifier can return a positive output of a fully erupted permanent tooth.

[0141] FIG. 2D is a flowchart describing a detector that uses first and second binary classifiers to determine an eruption status and tooth type of a target tooth. As described above, the detector of FIG. 2D is used when the target tooth comprises a 1 ^st premolar or canine. The detector of FIG. 2D is similar to the detector of FIG. 2C, except the classification determinations are in a slightly different order.

[0142] The flowchart of FIG. 2D describes the detector from step 217 of FIG. 2B that is used to determine the target tooth type and eruption status. Similar to above, the detector of FIG. 2D uses a hierarchical structure to convert multi-class classification problems into a cascading binary classification problem. The detector uses a level- 1 classifier (at step 271 of FIG. 2D) to address a first (and relatively easier) classification task followed by, if necessary, a level-2 classifier (at step 275 of FIG. 2D) to complete the classification of the target tooth. The level- 1 classifier can use a first set of normalized features, and optionally patient info, to address the first classification task, and the level 2 classifier can use a second set of normalized features, and optionally patient info, to address the second classification task.

[0143] Referring to step 271 of FIG. 2D, the detector uses a first set of normalized features (and, optionally patient info) in a level- 1 classifier to determine a first binary classification of the target tooth comprising a 1 ^st premolar or canine. The level- 1 classifier of the detector can implement various machine learning algorithms, including Decision Tree, Random Forest, Logistic Regression, Support Vector Machine, AdaBOOST, K-Nearest Neighbor (KNN), Quadratic Discriminant Analysis, Neural Network, etc. At step 273, the level-1 classifier can determine if the target tooth is a fully erupted permanent tooth based on the first set of normalized features and optionally the patient info. If the level-1 classifier at step 273 determines that the target tooth is a fully erupted permanent tooth, then the detector can return the target tooth status classification of "fully erupted permanent tooth" at step 281.

[0144] However, if the level-1 classifier determines that the target tooth is not a fully erupted permanent tooth, then at step 275 of FIG. 2D, the detector uses a second set of normalized features (and, optionally patient info) in a level-2 classifier to determine a second binary classification of the target tooth. The level-2 classifier of the detector can also implement the same various machine learning algorithms as the level-1 classifier. At step 277, the level-2 classifier can determine if the target tooth is a fully erupted primary tooth based on the second set of normalized features and optionally the patient info. If the level-2 classifier at step 277 determines that the target tooth is a fully erupted primary tooth, then the detector can return the target tooth status classification of "fully erupted primary tooth" at step 281. If the level-2 classifier determines that the target tooth is not a fully erupted primary tooth at step 277, then the level-2 classifier determines at step 279 that the target tooth is a permanent partially erupted/un- erupted tooth, and the detector can then return the target tooth status classification of "permanent partially erupted/un-erupted tooth" at step 281.

[0145] Table 5 describes the classifier design when the target tooth comprises a 1 ^st premolar or canine, including the input (normalized) features, and the output options at each stage of the detector. This classifier design is used for the detector of FIG. 2D. Table 5 - classifier design when target tooth comprises 1 ^st premolar or canine

[0146] Thus, according to Table 5, when the target tooth is a 1 ^st premolar or canine, the normalized features used by the level-1 classifier include normalized buccal-lingual width, normalized mesial-distal width, and crown height. The normalized features used by the level-2 classifier include normalized buccal-lingual width, normalized mesial-distal width, crown height, relative crown center Z, total number of cusps, and optionally patient age. The level-1 classifier can return a positive output of a fully erupted permanent tooth, and the level-2 classifier can return a positive output of a fully erupted primary tooth.

[0147] FIGS. 3A-3C are another set of flowcharts that show the overall detection system described above. FIG. 3A is a flowchart describing a method of extracting and generating data to be passed into a tooth status classification detector. These steps generally correspond to method steps 201-217 of FIG. 2B above.

[0148] At step 300 of FIG. 3A, data can be extracted for use by the detection system. The data can include patient teeth data (e.g., 3D model/scanning of teeth) as well as clinical data about the patient (e.g., patient age, gender, eruption sequence, measured space available for eruption etc.). Next, at step 302 of FIG. 3A, the detection system can generate features from the extracted data. This takes into account variance in the patient' s teeth to normalize the data set, as described above. Finally, at step 304 of FIG. 3A, the normalized features can be passed into the detector of FIG. 3B.

[0149] FIG. 3B is a flowchart describing a tooth status classification detector used to determine the eruption status and tooth type of a target tooth with the data from the flowchart of FIG. 3 A. At step 306 of FIG. 3B, the detector can confirm that the requisite normalized features were passed to the detector. At step 308, if any of the normalized features include a NaN ("not a number") or error message, an alert can be raised at step 310 and the detection process can be ended. If all the normalized features are present, then the normalized features can be passed on to the level-1 classifier at step 312. The level-1 classifier is further illustrated in FIG. 3C.

[0150] If the level-1 classifier at step 312 returns a positive result, then the positive result can be converted to a label at step 314 and output back to the system at step 316. The same labels can be used as described above for the FIG. 2C and 2D detectors. Thus, a positive result at step 312 for a 2 ^nd premolar target tooth can be converted at step 314 to a "fully erupted, primary" label, and a positive result at step 312 for a 1 ^st premolar or canine target tooth can be converted at step 314 to a "fully erupted, permanent" label.

[0151] If the level- 1 classifier at step 312 returns a negative result, then the normalized features are further passed on to the level-2 classifier at step 313. This level-2 classifier is also illustrated in FIG. 3C. The level-2 classifier similarly returns either a positive or negative result. Thus, a positive result at step 313 from the level-2 classifier for a 2 ^nd premolar target tooth can be converted at step 314 to a "fully erupted, permanent" label, and a positive result at step 313 for a 1 ^st premolar or canine target tooth can be converted at step 314 to a "fully erupted, primary" label. A negative result at step 313 from the level-2 classifier for a 2 ^nd premolar target tooth can be converted at step 314 to a "partially erupted, permanent" label, and a negative result at step

313 for a 1 ^st premolar or canine target tooth can be converted at step 214 to a "partially erupted, permanent" label.

[0152] FIG. 3C is a flowchart describing a detector of the detection system that determines an eruption status and tooth type of a target tooth. At step 318, the features are standardized.

Feature standardization is a common pre-processing procedure in machine learning and statistics. Next, at step 320, the detector of FIG. 3C makes a prediction, as described above. The prediction can be based on the set of normalized features passed to the detector. The prediction is binarized at step 322, and the passed back to the detection system for output.

[0153] FIG. 7 shows examples of tooth shape by detention type and eruption status. FIG. 6 shows the different tooth types and eruption status for the upper left 2 ^nd bicuspid, including 1) Permanent, Fully Erupted, 2) Permanent, Partially Erupted, and 3) Primary.

[0154] The methods described herein may be performed by an apparatus, such as a data processing system, which may include hardware, software, and/or firmware for performing many of these steps described above. For example, FIG. 8 is a simplified block diagram of a data processing system 500. Data processing system 500 typically includes at least one processor 502 which communicates with a number of peripheral devices over bus subsystem 504. These peripheral devices typically include a storage subsystem 506 (memory subsystem 508 and file storage subsystem 514), a set of user interface input and output devices 518, and an interface to outside networks 516, including the public switched telephone network. This interface is shown schematically as "Modems and Network Interface" block 516, and is coupled to corresponding interface devices in other data processing systems over communication network interface 524. Data processing system 500 may include a terminal or a low-end personal computer or a high- end personal computer, workstation or mainframe. [0155] The user interface input devices typically include a keyboard and may further include a pointing device and a scanner. The pointing device may be an indirect pointing device such as a mouse, trackball, touchpad, or graphics tablet, or a direct pointing device such as a touchscreen incorporated into the display. Other types of user interface input devices, such as voice recognition systems, may be used.

[0156] User interface output devices may include a printer and a display subsystem, which includes a display controller and a display device coupled to the controller. The display device may be a cathode ray tube (CRT), a flat-panel device such as a liquid crystal display (LCD), or a projection device. The display subsystem may also provide nonvisual display such as audio output.

[0157] Storage subsystem 506 maintains the basic programming and data constructs that provide the functionality of the present invention. The software modules discussed above are typically stored in storage subsystem 506. Storage subsystem 506 typically comprises memory subsystem 508 and file storage subsystem 514.

[0158] Memory subsystem 508 typically includes a number of memories including a main random access memory (RAM) 510 for storage of instructions and data during program execution and a read only memory (ROM) 512 in which fixed instructions are stored. In the case of Macintosh-compatible personal computers the ROM would include portions of the operating system; in the case of IBM-compatible personal computers, this would include the BIOS (basic input/output system).

[0159] File storage subsystem 514 provides persistent (nonvolatile) storage for program and data files, and typically includes at least one hard disk drive and at least one floppy disk drive (with associated removable media). There may also be other devices such as a CD-ROM drive and optical drives (all with their associated removable media). Additionally, the system may include drives of the type with removable media cartridges. The removable media cartridges may, for example be hard disk cartridges, such as those marketed by Syquest and others, and flexible disk cartridges, such as those marketed by Iomega. One or more of the drives may be located at a remote location, such as in a server on a local area network or at a site on the Internet's World Wide Web.

[0160] In this context, the term "bus subsystem" is used generically so as to include any mechanism for letting the various components and subsystems communicate with each other as intended. With the exception of the input devices and the display, the other components need not be at the same physical location. Thus, for example, portions of the file storage system could be connected over various local-area or wide-area network media, including telephone lines. Similarly, the input devices and display need not be at the same location as the processor, although it is anticipated that the present invention will most often be implemented in the context of PCS and workstations.

[0161] Bus subsystem 504 is shown schematically as a single bus, but a typical system has a number of buses such as a local bus and one or more expansion buses (e.g., ADB, SCSI, ISA, EISA, MCA, NuBus, or PCI), as well as serial and parallel ports. Network connections are usually established through a device such as a network adapter on one of these expansion buses or a modem on a serial port. The client computer may be a desktop system or a portable system.

[0162] Scanner 520 is responsible for scanning casts of the patient's teeth obtained either from the patient or from an orthodontist and providing the scanned digital data set information to data processing system 500 for further processing. In a distributed environment, scanner 520 may be located at a remote location and communicate scanned digital data set information to data processing system 500 over network interface 524.

[0163] Fabrication machine 522 fabricates dental appliances based on intermediate and final data set information received from data processing system 500. In a distributed environment, fabrication machine 522 may be located at a remote location and receive data set information from data processing system 500 over network interface 524.

[0164] Various alternatives, modifications, and equivalents may be used in lieu of the above components. Although the final position of the teeth may be determined using computer-aided techniques, a user may move the teeth into their final positions by independently manipulating one or more teeth while satisfying the constraints of the prescription.

[0165] Additionally, the techniques described here may be implemented in hardware or software, or a combination of the two. The techniques may be implemented in computer programs executing on programmable computers that each includes a processor, a storage medium readable by the processor (including volatile and nonvolatile memory and/or storage elements), and suitable input and output devices. Program code is applied to data entered using an input device to perform the functions described and to generate output information. The output information is applied to one or more output devices.

[0166] Each program can be implemented in a high level procedural or object-oriented programming language to operate in conjunction with a computer system. However, the programs can be implemented in assembly or machine language, if desired. In any case, the language may be a compiled or interpreted language.

[0167] Each such computer program can be stored on a storage medium or device (e.g., CD- ROM, hard disk or magnetic diskette) that is readable by a general or special purpose

programmable computer for configuring and operating the computer when the storage medium or device is read by the computer to perform the procedures described. The system also may be implemented as a computer-readable storage medium, configured with a computer program, where the storage medium so configured causes a computer to operate in a specific and predefined manner.

[0168] Thus, any of the methods (including user interfaces) described herein may be implemented as software, hardware or firmware, and may be described as a non-transitory computer-readable storage medium storing a set of instructions capable of being executed by a processor (e.g., computer, tablet, smartphone, etc.), that when executed by the processor causes the processor to control perform any of the steps, including but not limited to: displaying, communicating with the user, analyzing, modifying parameters (including timing, frequency, intensity, etc.), determining, alerting, or the like.

[0169] While preferred embodiments of the present disclosure have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only. Numerous variations, changes, and substitutions will now occur to those skilled in the art without departing from the invention. It should be understood that various alternatives to the embodiments of the invention described herein may be employed in practicing the invention. Numerous different combinations of embodiments described herein are possible, and such combinations are considered part of the present disclosure. In addition, all features discussed in connection with any one embodiment herein can be readily adapted for use in other embodiments herein. It is intended that the following claims define the scope of the invention and that methods and structures within the scope of these claims and their equivalents be covered thereby.

[0170] When a feature or element is herein referred to as being "on" another feature or element, it can be directly on the other feature or element or intervening features and/or elements may also be present. In contrast, when a feature or element is referred to as being "directly on" another feature or element, there are no intervening features or elements present. It will also be understood that, when a feature or element is referred to as being "connected", "attached" or "coupled" to another feature or element, it can be directly connected, attached or coupled to the other feature or element or intervening features or elements may be present. In contrast, when a feature or element is referred to as being "directly connected", "directly attached" or "directly coupled" to another feature or element, there are no intervening features or elements present. Although described or shown with respect to one embodiment, the features and elements so described or shown can apply to other embodiments. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature. [0171] Terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. For example, as used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items and may be abbreviated as "/".

[0172] Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if a device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. The device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

[0173] Although the terms "first" and "second" may be used herein to describe various features/elements (including steps), these features/elements should not be limited by these terms, unless the context indicates otherwise. These terms may be used to distinguish one

feature/element from another feature/element. Thus, a first feature/element discussed below could be termed a second feature/element, and similarly, a second feature/element discussed below could be termed a first feature/element without departing from the teachings of the present invention.

[0174] Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising" means various components can be co-jointly employed in the methods and articles (e.g., compositions and apparatuses including device and methods). For example, the term

"comprising" will be understood to imply the inclusion of any stated elements or steps but not the exclusion of any other elements or steps.

[0175] In general, any of the apparatuses and/or methods described herein should be understood to be inclusive, but all or a sub-set of the components and/or steps may alternatively be exclusive, and may be expressed as "consisting of or alternatively "consisting essentially of the various components, steps, sub-components or sub-steps.

[0176] As used herein in the specification and claims, including as used in the examples and unless otherwise expressly specified, all numbers may be read as if prefaced by the word "about" or "approximately," even if the term does not expressly appear. The phrase "about" or

"approximately" may be used when describing magnitude and/or position to indicate that the value and/or position described is within a reasonable expected range of values and/or positions. For example, a numeric value may have a value that is +/- 0.1% of the stated value (or range of values), +/- 1% of the stated value (or range of values), +/- 2% of the stated value (or range of values), +/- 5% of the stated value (or range of values), +/- 10% of the stated value (or range of values), etc. Any numerical values given herein should also be understood to include about or approximately that value, unless the context indicates otherwise. For example, if the value "10" is disclosed, then "about 10" is also disclosed. Any numerical range recited herein is intended to include all sub-ranges subsumed therein. It is also understood that when a value is disclosed that "less than or equal to" the value, "greater than or equal to the value" and possible ranges between values are also disclosed, as appropriately understood by the skilled artisan. For example, if the value "X" is disclosed the "less than or equal to X" as well as "greater than or equal to X" (e.g., where X is a numerical value) is also disclosed. It is also understood that the throughout the application, data is provided in a number of different formats, and that this data, represents endpoints and starting points, and ranges for any combination of the data points. For example, if a particular data point "10" and a particular data point "15" are disclosed, it is understood that greater than, greater than or equal to, less than, less than or equal to, and equal to 10 and 15 are considered disclosed as well as between 10 and 15. It is also understood that each unit between two particular units are also disclosed. For example, if 10 and 15 are disclosed, then 11, 12, 13, and 14 are also disclosed.

[0177] Although various illustrative embodiments are described above, any of a number of changes may be made to various embodiments without departing from the scope of the invention as described by the claims. For example, the order in which various described method steps are performed may often be changed in alternative embodiments, and in other alternative

embodiments one or more method steps may be skipped altogether. Optional features of various device and system embodiments may be included in some embodiments and not in others.

Therefore, the foregoing description is provided primarily for exemplary purposes and should not be interpreted to limit the scope of the invention as it is set forth in the claims.

[0178] The examples and illustrations included herein show, by way of illustration and not of limitation, specific embodiments in which the patient matter may be practiced. As mentioned, other embodiments may be utilized and derived there from, such that structural and logical substitutions and changes may be made without departing from the scope of this disclosure. Such embodiments of the inventive patient matter may be referred to herein individually or collectively by the term "invention" merely for convenience and without intending to voluntarily limit the scope of this application to any single invention or inventive concept, if more than one is, in fact, disclosed. Thus, although specific embodiments have been illustrated and described herein, any arrangement calculated to achieve the same purpose may be substituted for the specific embodiments shown. This disclosure is intended to cover any and all adaptations or variations of various embodiments. Combinations of the above embodiments, and other embodiments not specifically described herein, will be apparent to those of skill in the art upon reviewing the above description.