System And Method For Forming A Custom Medical Mask From A Three-dimensional Electronic Model

Abstract

According to one embodiment, a custom medical mask formed for a particular user from a three-dimensional electronic model includes a body formed from a polymerized photopolymer material. An interior surface of the body is configured to seat on the particular user's face and comprises a physical embodiment of a three-dimensional electronic model corresponding to unique facial features of the particular user. According to another embodiment, a method of creating a three-dimensional electronic model for use in forming a custom medical mask for a particular user includes scanning a portion of the particular user's face using an electronic scanning device, generating a three-dimensional electronic model of the portion of the particular user's face based on the scanning, and transmitting the three-dimensional electronic model of the portion of the particular user's face for use in forming the custom medical mask for the particular user from a photopolymer using a stereolithography apparatus.

Description

RELATED APPLICATION

[0001] This application claims the benefit under 35 U.S.C. .sctn.119(e) of U.S. Provisional Application Ser. No. 60/806,657 filed Jul. 6, 2006.

TECHNICAL FIELD

[0002] This invention relates generally to masks for use in medical and other clinical applications, and more particularly to a system and method for forming a custom medical mask from a three-dimensional electronic model.

BACKGROUND

[0003] Many people experience breathing problems on a recurring basis, which often result in sleep disordered breathing (i.e., difficulty sleeping, snoring, or other more serious conditions such as obstructive sleep apnea). As technology advances, people with such breathing problems demand increased performance and comfort. Previous devices for improving a user's breathing have included face masks, nose masks, or nasal inserts that help deliver air to the user's nose at positive pressure. These devices help force open the user's breathing passage and thereby improve the user's breathing. However, previous devices have often provided an inadequate fit and thus have caused discomfort for users and failed to adequately prevent leakage.

OVERVIEW

[0004] According to one embodiment, a custom medical mask formed for a particular user from a three-dimensional electronic model includes a body formed from a polymerized photopolymer material. An interior surface of the body is configured to seat on the particular user's face and comprises a physical embodiment of a three-dimensional electronic model corresponding to unique facial features of the particular user.

[0005] According to another embodiment, a method of creating a three-dimensional electronic model for use in forming a custom medical mask for a particular user includes scanning at least a portion of the particular user's face using an electronic scanning device, generating a three-dimensional electronic model of the portion of the particular user's face based on the scanning, and transmitting the three-dimensional electronic model of the portion of the particular user's face for use in forming the custom medical mask for the particular user from a photopolymer using a stereolithography apparatus.

[0006] According to another embodiment, a system for forming a custom medical mask for a particular user from a three-dimensional electronic model includes a photopolymer material, a three-dimensional electronic model of a custom medical mask, and a stereolithography apparatus. The three-dimensional electronic model includes a first surface that corresponds to unique facial features of the particular user. The stereolithography apparatus is operable to focus a light source on the photopolymer material in a pattern corresponding to the three-dimensional electronic model to polymerize the photopolymer material to form the custom medical mask for the particular user.

[0007] Certain embodiments may provide one or more technical advantages. For example, certain embodiments may provide a custom medical mask that conforms substantially optimally to a user's unique facial features. Certain embodiments may provide improved fit, increased comfort, reduced leakage, and improved performance, whether for treating sleep disordered breathing, administering anesthesia, or any other suitable purpose for which the custom medical mask is used. In certain embodiments the process of creating the three-dimensional electronic model does not apply any force to the particular user's face that may affect the shape of the model and the resulting custom medical mask. Certain embodiments may allow for the more efficient fabrication of a custom medical mask, which may include more efficient methods for fabricating one or more fittings and or openings for a custom medical mask. Certain embodiments may allow for data communication over the Internet or other network such that acquiring data needed to create the three-dimensional electronic model and fabricating the custom medical mask from the three-dimensional electronic model may be performed in different locations remote from one another. Certain embodiments may provide all, some, or none of these advantages. Certain embodiments may provide one or more other technical advantages, one or more of which may be apparent to those skilled in the art from the figures, descriptions, and claims included herein.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] For a more complete understanding of the present invention and certain of its advantages, reference is now made to the following description, taken in conjunction with the accompanying drawings, in which:

[0009] FIG. 1 illustrates an example method for forming a custom medical mask;

[0010] FIG. 2 illustrates an example system for forming a custom medical mask;

[0011] FIG. 3 illustrates an example module for use with an example processing system;

[0012] FIGS. 4A to 4E illustrate example electronic models for use in forming a custom medical mask;

[0013] FIG. 5 illustrates an example custom medical mask;

[0014] FIGS. 6A and 6B illustrate example electronic models for use in forming a custom medical mask with an oral chamber;

[0015] FIG. 7 illustrates an example custom medical mask with an oral chamber;

[0016] FIGS. 8A and 8B illustrate example electronic models for use in forming a custom medical mask with a receptacle for a coupling device;

[0017] FIG. 9 illustrates an example custom medical mask with a receptacle for a coupling device;

[0018] FIG. 10 illustrates an example electronic model for use in forming a custom medical mask with a fitting for a clinical gas delivery system; and

[0019] FIG. 11 illustrates an example custom medical mask with a fitting for a clinical gas delivery system.

DESCRIPTION OF EXAMPLE EMBODIMENTS

[0020] FIG. 1 illustrates an example method 10 for forming a custom medical mask 18. In certain embodiments, steps of method 10 may include data acquisition 12, data processing 14, and mask fabrication 16 to form custom medical mask 18.

[0021] In certain embodiments, data acquisition 12 may represent a process for collecting three-dimensional coordinate data corresponding to unique facial features of a particular user. In certain embodiments, data acquisition 12 may be performed using surface digitization and/or three-dimensional measurement techniques. For example, data acquisition 12 may utilize optical, acoustical, and/or other scanning techniques, physical probing techniques, and/or any other suitable techniques. In a particular embodiment, data acquisition 12 may utilize one or more optical scanners to acquire three-dimensional coordinate data corresponding to certain features of a particular user's face. The three-dimensional coordinate data collected through data acquisition 12 may be formatted in any suitable manner. For example, the three-dimensional coordinate data may be formatted as a three-dimensional computer aided drafting (CAD) model. In a particular embodiment, the three-dimensional coordinate data may be stored as one or more point-cloud models.

[0022] In certain embodiments, data processing 14 may represent one or more processes for electronically manipulating and/or modifying the coordinate data collected in data acquisition 12. These processes may include screening the coordinate data collected in data acquisition 12, fitting the coordinate data collected in data acquisition 12, converting the coordinate data collected in data acquisition 12 from one format to another, and/or any of a number of well-known data processing techniques known for use with three-dimensional coordinate data. For example, screening the coordinate data (also known as smoothing) may include identification, modification, and/or removal of outlier coordinate data points. As another example, fitting (also known as stitching) may include aligning multiple sets of coordinate data collected in data acquisition 12 such that the multiple sets may be used together to form a single coordinate data set. As another example, the coordinate data collected in data acquisition 12 may be formatted as a point-cloud model and may be converted to a polygon mesh model, Non-Uniform Rational B-Spline (NURBS) model, stereolithography (STL) model, and/or any other appropriate three-dimensional electronic model.

[0023] In certain embodiments, mask fabrication 16 may represent a process for forming custom medical mask 18 as a physical embodiment of a three-dimensional electronic model developed through data acquisition 12 and data processing 14. In particular embodiments, mask fabrication 16 may represent one or more well-known rapid-prototyping techniques such as, for example, three-dimensional printing (3DP), selective laser sintering (SLS), and/or STL. One or more of these processes may be used to form custom medical mask 18 as a physical embodiment of a three-dimensional electronic model, such that custom medical mask 18 is configured to provide a custom fit to unique facial features of a particular user.

[0024] FIG. 2 illustrates an example system 20 for forming a custom medical mask 18 according to certain embodiments of method 10. In the embodiment shown, system 20 includes scanning system 22, processing system 26, and fabrication system 28. In particular embodiments, scanning system 22 may be coupled to processing system 26 through one or more data connections 30, allowing for data communication between scanning system 22 and processing system 26. Similarly, in certain embodiments, processing system 26 may be coupled to fabrication system 28 through the use of one or more data connections 32, allowing for data communication between processing system 26 and fabrication system 28. In certain embodiments, as shown in FIG. 2, processing system 26 and fabrication system 28 may be included in a combination system 24 that provides the functionality of both processing system 26 and fabrication system 28. In alternative embodiments, scanning system 22 and processing system 26 may be included within a combination system that provides the functionality of both scanning system 22 and processing system 26. In addition, in certain embodiments, the functionality of one or more of scanning system 22, processing system 26, and fabrication system 28 may each be distributed among multiple components.

[0025] Each of scanning system 22, processing system 26, and fabrication system 28 may include one or more processing modules. FIG. 3 illustrates an example processing module 34 for use in system 20. Processing module 34 may include one or more processing units 36 coupled to one or more memory units 38 (which will be referred to as "processing unit 36" and "memory unit 38" throughout the remainder of this description). In certain embodiments, operations performed by processing module 34 are collectively performed by processing unit 36 and memory unit 38. Processing unit 36 may include any suitable microprocessor or microcontroller, according to particular needs. Memory unit 38 may take the form of volatile or nonvolatile memory including, without limitation, magnetic media, optical media, random access memory (RAM), read-only memory (ROM), removable media, or any other suitable data storage component.

[0026] Referring back to FIG. 2, scanning system 22 represents a system for collecting three-dimensional coordinate data for one or more surfaces of a physical object. Scanner 22 may utilize one or more of numerous well-known coordinate data collection techniques. In certain embodiments, scanning system 22 represents an optical scanner. In a particular embodiment, scanning system 22 represents a hand-held three-dimensional optical scanner, such as a HANDYSCAN 3D available from AGILE MANUFACTURING INC. of Ontario, Canada.

[0027] Processing system 26 represents an electronic system for use in performing one or more processes associated with data processing 14 on the three-dimensional coordinate data collected by scanning system 22. In certain embodiments, processing system 26 may represent a general purpose computer loaded with one or more software applications on a computer-readable medium. In a particular embodiment, these one or more software applications may include GEOMAGIC STUDIO available from RAINDROP GEOMAGIC, INC. of Research Triangle Park, N.C.

[0028] Fabrication system 28 represents a fully-automated or partially-automated system for forming a physical object from a three-dimensional electronic model. In certain embodiments, fabrication system 28 may represent a 3DP system, an SLS system, and/or an STL apparatus (SLA). In certain embodiments, an SLA operates by "building" parts one layer at a time. In certain embodiments, each layer may be formed by tracing a beam of light across the surface of a photo-reactive liquid, such as a photopolymer. In certain embodiments, the light may be focused on the surface of the photopolymer using one or more lasers each having a wavelength that is selected to interact with the photopolymer to cause the selective polymerization of the photopolymer wherever the laser is focused. In a particular embodiment, fabrication system 28 may be a VIPER SLA system, available from 3D SYSTEMS, INC. of Valencia, Calif. In a particular embodiment, the material used in fabrication system 28 to form custom medical mask 18 may include a photo-reactive epoxy resin, such as the FOTOTEC SL resin available from DREVE OTOPLASTIK, GmbH of Germany.

[0029] Data connections 30 and 32 each may represent one or more data connections providing for data communication between scanning system 22 and processing system 26 and between processing system 26 and fabrication system 28, respectively. Connections 30 and 32 may include wireline, wireless, and/or optical connections. In certain embodiments, one or more of connections 30 and 32 may represent a network such as a local area network (LAN), metropolitan area network (MAN), wide area network (WAN), global communications network such as the Internet, or any other suitable network. In certain embodiments, one or more of connections 30 and 32 may include a single network and/or multiple networks of the same type or different types to couple these components to one another, according to particular needs.

[0030] FIGS. 4A through 4E illustrate example electronic models 40 for use in forming a custom medical mask 18. In certain embodiments, one or more electronic models 40 may be stored in one or more memory units 38 within one or more processing modules 34 of system 20. FIG. 4A illustrates an example point-cloud model 40a that includes a cloud of three-dimensional coordinate data. Point-cloud model 40a represents an example of three-dimensional coordinate data that may be collected through data acquisition 12 and/or through the use of one or more scanning systems 22. For example, point-cloud model 40a may represent a collection of individual coordinate data points corresponding with electronic measurements of facial features of a particular user taken by one or more scanning systems 22. In certain embodiments, point cloud model 40a may represent multiple individual scans of a particular user's face, with each scan fitted or stitched together with other scans to form a single point-cloud model 40a. Point-cloud model 40a may be stored as a text file, as a comma delimited file, as a tab delimited file, and/or in any other appropriate electronic format.

[0031] FIG. 4B illustrates an example polygon mesh model 40b that includes a plurality of polygons interconnected to form a mesh. In certain embodiments, polygon mesh model 40a may be formed from point-cloud model 40a through a process of selectively connecting adjacent pairs of coordinate data points from point-cloud model 40a. In certain embodiments, multiple polygons may be combined and/or merged together to reduce the total number of polygons included in polygon mesh model 40b. In the embodiment shown, each polygon included within polygon mesh model 40b is represented as a triangle. In alternative embodiments, any appropriate polygon or polygons may be used to form polygon mesh model 40b. Polygon mesh model 40b may be stored as a wire frame model, as a surface model, and/or in any other appropriate electronic format.

[0032] FIG. 4C illustrates an example NURBS model 40c. In certain embodiments, NURBS model 40c may represent one or more continuous surfaces mathematically approximating numerous polygons from polygon mesh model 40b. NURBS model 40c may be stored as an Initial Graphics Exchange Specification (IGES) model, as a Standard for the Exchange of Product Model Data (STEP) model, as an STL model, and/or in any other appropriate electronic format.

[0033] FIG. 4D illustrates an example solid model 40d. Solid model 40d may represent an electronic model created by extruding and/or offsetting one or more surfaces from NURBS model 40c and/or polygon mesh model 40b. Solid model 40d may be stored as an IGES model, as a STEP model, as an STL model, and/or in any other appropriate electronic format.

[0034] FIG. 4E illustrates an example trimmed model 40e. Trimmed model 40e may represent a trimmed version of solid model 40d with one or more surfaces limited by one or more trim surfaces 42. Trimmed model 40e may be stored as an IGES model, as a STEP model, as an STL model, and/or in any other appropriate electronic format.

[0035] In operation, according to particular embodiments, scanning system 22 may collect coordinate data from the facial features of a particular user. This coordinate data may be utilized to generate point-cloud model 40a according to data acquisition 12. In certain embodiments, point-cloud model 40a may be communicated via connection 30 or otherwise to processing system 26. Processing system 26 may perform one or more processing steps to manipulate and/or modify the data collected by scanning system 22, according to data processing 14. For example, the data collected by scanning system 22 may be converted from point-cloud model 40a to one or more of polygon mesh model 40b and NURBS model 40c. In certain embodiments, one or more of polygon mesh model 40b and NURBS model 40c may be offset and/or extruded to form solid model 40d. The thickness of the offset and/or extrusion may correspond to a selected thickness for custom medical mask 18. For example, in certain embodiments, the offset and/or extrusion thickness of solid model 40d may be in the range between 0.05 and 0.20 inches. In a particular embodiment, the offset and/or extrusion thickness of solid model 40d may be 0.125 inches. In certain embodiments, the offset and/or extrusion thickness of solid model 40d may vary and may be different for different portions of solid model 40d.

[0036] In certain embodiments, solid model 40d may be trimmed to selectively adjust and/or define a periphery of solid model 40d using one or more trim surfaces 42 to create trimmed model 40e. In certain embodiments, the one or more trim surfaces 42 may be generated and/or utilized to define a periphery to correspond with a selected shape for custom medical mask 18. For example, in a particular embodiment, one or more trim surfaces 42 may be generated and/or utilized to define a periphery around a region corresponding to the particular user's mouth and portions of the particular user's nose. In certain embodiments, the step of trimming one or more surfaces to define a periphery may be performed with one or more of point-cloud model 40a, polygon mesh model 40b, NURBS model 40c, and/or solid model 40d. In certain embodiments, trimmed model 40e may be communicated via connection 32 or otherwise to fabrication system 28. Fabrication system 28 may perform one or more steps to form custom medical mask 18 from trimmed model 40e.

[0037] FIG. 5 illustrates an example custom medical mask 18 that may be formed, at least in part, by fabrication system 28. As shown, custom medical mask 18 may include body 60, one or more openings 62, and/or one or more tabs 64. Body 60 may represent one or more pieces of thin material configured to cover the particular user's nose and/or mouth. The one or more pieces of thin material may be shaped to correspond to the unique facial features of the particular user. The one or more pieces of thin material may include a polymerized photopolymer material. The one or more openings 62 may allow for access through body 60 to the particular user's nostrils and/or mouth, when custom medical mask 18 is positioned over the particular user's face. Tab 64 may operate to couple custom medical mask 18 to one or more straps and/or other devices to couple custom medical mask 18 to the particular user. One or more of openings 62 and/or tabs 64 may be integrally formed with body 60 when custom medical mask 18 is formed with fabrication system 28. In these embodiments, electronic model 40 used with fabrication system 28 to form custom medical mask 18 may include model elements corresponding to the one or more openings 62 and/or tabs 64. In alternative embodiments, one or more of openings 62 and/or tabs 64 may be added to body 60 after custom medical mask 18 is formed with fabrication system 28. For example, one or more openings 62 may be cut, drilled, and/or pressed out of body 60 after body 60 has been formed. Similarly, one or more tabs 64 may be coupled to body 60 through the use of an adhesive or any other appropriate coupling technique.

[0038] In certain embodiments, the periphery of custom medical mask 18 may be defined by trim surface 42 in trimmed model 40e prior to forming custom medical mask 18 with fabrication system 28. In certain embodiments, the periphery of custom medical mask 18 may be further modified and/or trimmed to achieve an improved fit and/or desired shape for custom medical mask 18 after custom medical mask 18 is formed by fabrication system 28.

[0039] FIGS. 6A and 6B illustrate example electronic models 40 for use in forming a custom medical mask 18 with an oral chamber. In certain embodiments, it may be advantageous to form a custom medical mask 18 having a chamber substantially surrounding the mouth or lips of a particular user. Such a chamber may be advantageous to allow the mouth and/or lips of the particular user to move while the particular user is wearing custom medical mask 18. In certain embodiments, electronic model 40 for use in forming custom medical mask 18 having an oral chamber may be generated through the use of chamber model 44. Chamber model 44 may represent an electronic surface and/or solid model corresponding to a selected shape for an oral chamber for custom medical mask 18. In certain embodiments, chamber model 44 may be combined, overlaid, and/or merged with electronic model 40. In certain embodiments, once chamber model 44 has been combined, overlaid, and/or merged with electronic model 40, a trimmed model 40f may be developed such that at least a portion of trimmed model 40f in region 46 does not directly correspond to the facial features of the particular user.

[0040] In an alternative embodiment, rather than using chamber model 44 to generate trimmed model 40f, a physical mold or other structure may be placed on the face of the particular user at the time of data acquisition 12. In these embodiments, the three-dimensional coordinate data collected for the particular user's face may also include three-dimensional coordinate data of the mold or structure. This three-dimensional coordinate data may then be used to generate trimmed model 40f such that at least a portion of trimmed model 40f in region 46 does not directly correspond to the facial features of the particular user.

[0041] FIG. 7 illustrates an example custom medical mask 18, with oral chamber 66, that may be formed, at least in part, by fabrication system 28. As shown, in addition to the features described above in relation to FIG. 5, custom medical mask 18 may include oral chamber 66. Oral chamber 66 may represent a region of body 60 corresponding with an area around the mouth or lips of the particular user that is configured to be offset from the lips or mouth of the particular user when custom medical mask 18 is positioned on the particular user's face. In certain embodiments, custom medical mask 18 may be formed with fabrication system 28 using trimmed model 40f. In certain embodiments, custom medical mask 18 with oral chamber 66 may allow the particular user to move their mouth and/or lips while custom medical mask 18 is positioned on the particular user's face.

[0042] FIGS. 8A and 8B illustrate example electronic models 40 for use in forming a custom medical mask 18 with a receptacle for a coupling device. In certain embodiments, it may be advantageous to form a custom medical mask 18 configured for use with a coupling device 80. Coupling device 80 may represent one or more structures configured to couple custom medical mask 18 to an oral appliance. In a particular embodiment, coupling device 80 may represent a sleeve with an opening 82 configured to receive a post and/or other structure of an oral appliance. In particular embodiments, coupling device 80 may further include one or more openings 84 configured to receive a threaded set screw 86 to retain a post and/or other structure of an oral appliance within coupling device 80. In certain embodiments, an electronic model 40 for use in forming a custom medical mask having a receptacle for a coupling device may be generated through the use of receptacle model 48. Receptacle model 48 may represent an electronic surface and/or solid model corresponding to a selected shape for a receptacle for coupling device 80. In a particular embodiment, receptacle model 48 may represent an electronic surface and/or solid model shaped to substantially surround the outer dimensions of coupling device 80. In certain embodiments, receptacle model 48 may be combined, overlaid, and/or merged with electronic model 40. In certain embodiments, once receptacle model 48 has been combined, overlaid, and/or merged with electronic model 40, a trimmed model 40g may be developed for use in forming a custom medical mask 18 with a receptacle for coupling device 80.

[0043] In an alternative embodiment, rather than using receptacle model 44 to generate trimmed model 40g, a coupling device 80 may be positioned on or near the face of the particular user at the time of data acquisition 12. In these embodiments, the three-dimensional coordinate data collected for the particular user's face may also include three-dimensional coordinate data of coupling device 80. This three-dimensional coordinate data may then be used to generate trimmed model 40g such that trimmed model 40g includes a region shaped to substantially surround the outer dimensions of coupling device 80. Similarly, in certain embodiments, the three-dimensional coordinate data collected for the particular user's face may also include three-dimensional coordinate data of a portion of an oral appliance. In embodiments in which the collected three-dimensional coordinate data includes three-dimensional coordinate data of a portion of an oral appliance, the data may be used to form a custom medical mask that is custom oriented to the oral appliance based on this collected data. In a particular embodiment, coupling device 80 may be precisely positioned relative to the teeth and unique facial features of the particular user at the time of data acquisition 12, such that custom medical mask 18 formed using the data collected in data acquisition 12 may be custom oriented to the particular user's teeth and unique facial features. For example, an oral appliance with a post may be positioned within the particular user's mouth and coupling device 80 may be coupled to a post of the oral appliance positioned within the particular user's mouth at the time of data acquisition 12. An oral appliance positioned within the particular user's mouth may include a bite register, a wax mold, an upper arch, and/or a lower arch.

[0044] FIG. 9 illustrates an example custom medical mask 18 with receptacle 68 for a coupling device 80. Custom medical mask 18 with receptacle 68 may be formed, at least in part, by fabrication system 28. As shown, in addition to the features described above in relation to FIGS. 5 and 7, custom medical mask 18 may include receptacle 68 configured to receive coupling device 80. Receptacle 68 may represent a sleeve or enclosure in body 60 shaped to receive and/or support coupling device 80. As shown, receptacle 68 may include opening 70. Opening 70 may be configured to allow access through body 60 for another structure, such as a post of an oral appliance. One or more of receptacle 68 and/or opening 70 may be integrally formed with body 60 when custom medical mask 18 is formed with fabrication system 28. In these embodiments, electronic model 40 used with fabrication system 28 to form custom medical mask 18 may include model elements corresponding to the one or more of receptacle 68 and/or opening 70. For example, custom medical mask 18 may be formed with fabrication system 28 using trimmed model 40g. In alternative embodiments, one or more of receptacle 68 and/or opening 70 may be added to body 60 after custom medical mask 18 is formed with fabrication system 28. For example, opening 70 may be cut, drilled, and/or pressed out of body 60 after body 60 has been formed. In certain embodiments, custom medical mask 18 with receptacle 68 may cooperate with coupling device 80 to couple custom medical device 18 to an oral appliance to improve the positioning and/or fit of custom medical mask 18 for the particular user.

[0045] FIG. 10 illustrates an example electronic model for use in forming a custom medical mask 18 with a fitting for a clinical gas delivery system. In certain embodiments, it may be advantageous for custom medical mask 18 to couple to a suitable clinical gas delivery system. A suitable clinical gas delivery system may be a Continuous Positive Airway Pressure (CPAP) system, a Bilevel Positive Airway Pressure (BiPAP) system, and/or a system configured to deliver an anesthetic, oxygen, and/or other appropriate clinical gases to a particular user wearing custom medical mask 18. In certain embodiments, an electronic model 40 for use in forming a custom medical mask having a fitting for a clinical gas delivery system may be generated through the use of fitting model 50. In certain embodiments, fitting model 50 may be combined, overlaid, and/or merged with electronic model 40 to generate trimmed model 40h. Fitting model 50 may represent an electronic replica of a fitting configured to couple custom medical mask 18 to a clinical gas delivery system. In certain embodiments, once fitting model 50 has been combined, overlaid, and/or merged with electronic model 40, a trimmed model 40h may be developed for use in forming a custom medical mask 18 with a fitting for a clinical gas delivery system.

[0046] FIG. 11 illustrates an example custom medical mask 18 with fitting 72 for a clinical gas delivery system. Custom medical mask 18 with fitting 72 may be formed, at least in part, by fabrication system 28. As shown, in addition to the features described above in relation to FIGS. 5, 7, and 9, custom medical mask 18 may include fitting 72 configured to couple to a clinical gas delivery system such as a CPAP system or a BiPAP system. Fitting 72 may represent a structure configured to deliver a flow of gas from one or more hoses and/or tubes through an opening in body 60. In a particular embodiment, fitting 72 may represent a tube positioned to deliver a flow of gas to one or more nostrils of the particular user when the custom medical mask is positioned on the particular user's face. Fitting 72 may be integrally formed with body 60 when custom medical mask 18 is formed with fabrication system 28. In these embodiments, electronic model 40 used with fabrication system 28 to form custom medical mask 18 may include model elements corresponding to fitting 72. For example, custom medical mask 18 may be formed with fabrication system 28 using trimmed model 40h. In alternative embodiments, fitting 72 may be added to body 60 after custom medical mask 18 is formed with fabrication system 28. For example, fitting 72 may be coupled to body 60 through the use of an adhesive or any other appropriate coupling technique. In certain embodiments, custom medical mask 18 with fitting 72 may cooperate with a clinical gas delivery system to deliver a clinical gas, such as anesthetic, oxygen, and/or air, to the particular user when the custom medical mask is positioned on the particular user's face.

[0047] Although the present invention has been described in several embodiments, a plenitude of changes, substitutions, variations, transformations, and modifications may be suggested to one skilled in the art, and it is intended that the present invention encompass such changes, substitutions, variations, transformations, and modifications as fall within the scope of the appended claims.

Claims

1-20. (canceled)

21. A method for use in forming a custom medical mask for a particular user, the method comprising: scanning at least a portion of a particular user's face using an electronic scanning device; generating a three-dimensional electronic model of the portion of the particular user's face based on the scanning; processing the three-dimensional electronic model to form an electronic model of a custom medical mask, the processing comprising: merging the three-dimensional electronic model with an electronic fitting model representing a fitting shaped to couple to a clinical gas delivery system; and merging the three-dimensional electronic model with an electronic model selected from the group consisting of: a model of an oral chamber shaped to be offset from the mouth of the particular user when the custom medical mask is positioned on the particular user's face; and a model of a coupling device shaped to couple the custom medical mask to an oral appliance; and transmitting the electronic model of the custom medical mask for use in forming a custom medical mask for the particular user with a rapid prototyping technique.

22. The method of claim 21, wherein the three-dimensional electronic model further comprises extruding a surface of the three-dimensional electronic model in a direction normal to the surface a distance between 0.05 and 0.20 inches.

23. The method of claim 21, wherein the rapid prototyping technique includes a technique selected from the group consisting of three-dimensional printing, selective laser sintering, and stereolithography.

24. A method for use in forming a custom medical mask for a particular user, the method comprising: scanning at least a portion of a particular user's face using an electronic scanning device; generating a three-dimensional electronic model of the portion of the particular user's face based on the scanning; processing the three-dimensional electronic model to form an electronic model of a custom medical mask, the processing comprising: merging the three-dimensional electronic model with an electronic fitting model representing a fitting shaped to couple to a clinical gas delivery system; and merging the three-dimensional electronic model with an electronic model of an oral chamber shaped to be offset from the mouth of the particular user when the custom medical mask is positioned on the particular user's face; and transmitting the electronic model of the custom medical mask for use in forming a custom medical mask for the particular user with a rapid prototyping technique.

25. A method for use in forming a custom medical mask for a particular user, the method comprising: scanning at least a portion of a particular user's face using an electronic scanning device; generating a three-dimensional electronic model of the portion of the particular user's face based on the scanning; processing the three-dimensional electronic model to form an electronic model of a custom medical mask, the processing comprising: merging the three-dimensional electronic model with an electronic fitting model representing a fitting shaped to couple to a clinical gas delivery system; and merging the three-dimensional electronic model with an electronic model of a coupling device shaped to couple the custom medical mask to an oral appliance; and transmitting the electronic model of the custom medical mask for use in forming a custom medical mask for the particular user with a rapid prototyping technique.

26. A custom medical mask formed for a particular user from a three-dimensional electronic model, comprising: a body having an interior surface and an exterior surface, wherein the interior surface of the body is configured to seat on the particular user's face and comprises a physical embodiment of a three-dimensional electronic model corresponding to unique facial features of the particular user; a fitting configured to couple to a clinical gas delivery system, wherein the fitting and the body form one integral piece of material; and at least one selected from the group consisting of: an oral chamber shaped to be offset from the mouth of the particular user when the custom medical mask is positioned on the particular user's face; and a coupling device shaped to couple the custom medical mask to an oral appliance; wherein the three-dimensional electronic model was merged with an electronic fitting model and at least one of a model of an oral chamber and a model of a coupling device.

27. The custom medical mask of claim 26, wherein the exterior surface of the body is offset from the interior surface a distance between 0.05 and 0.20 inches.

28. A custom medical mask formed for a particular user from a three-dimensional electronic model, comprising: a body having an interior surface and an exterior surface, wherein the interior surface of the body is configured to seat on the particular user's face and comprises a physical embodiment of a three-dimensional electronic model corresponding to unique facial features of the particular user; a fitting configured to couple to a clinical gas delivery system, wherein the fitting and the body form one integral piece of material; and an oral chamber shaped to be offset from the mouth of the particular user when the custom medical mask is positioned on the particular user's face; and wherein the three-dimensional electronic model was merged with an electronic fitting model and a model of an oral chamber.

29. A custom medical mask formed for a particular user from a three-dimensional electronic model, comprising: a body having an interior surface and an exterior surface, wherein the interior surface of the body is configured to seat on the particular user's face and comprises a physical embodiment of a three-dimensional electronic model corresponding to unique facial features of the particular user; a fitting configured to couple to a clinical gas delivery system, wherein the fitting and the body form one integral piece of material; and a coupling device shaped to couple the custom medical mask to an oral appliance; wherein the three-dimensional electronic model was merged with an electronic fitting model and a model of a coupling device.

30. A computer-implemented system for use in connection with forming a custom medical mask for a particular user from a three-dimensional electronic model, comprising: one or more memory units storing a three-dimensional electronic model of a custom medical mask, the three-dimensional electronic model suited for use with a rapid prototyping system; and one or more processing units coupled to the one or more memory units and operable to access the three-dimensional electronic model in the one or more memory units for use in connection with forming a custom medical mask for a particular user using the rapid prototyping system; wherein the three-dimensional electronic model of the custom medical mask comprises: a first surface that corresponds to unique facial features of the particular user; a model of a fitting configured to couple to a clinical gas delivery system; a model selected from the group consisting of: a model of an oral chamber shaped to be offset from the mouth of the particular user when the custom medical mask is positioned on the particular user's face; and a model of a coupling device shaped to couple the custom medical mask to an oral appliance; wherein the model of the fitting and the selected model have been merged with the first surface.

31. The system of claim 30, wherein the three-dimensional electronic model further comprises a second surface offset from the first surface a distance between 0.05 and 0.20 inches.

32. The system of claim 30, wherein the one or more processing units are operable to access the three-dimensional electronic model over a network.

33. A computer-implemented system for use in connection with forming a custom medical mask for a particular user from a three-dimensional electronic model, comprising: one or more memory units storing a three-dimensional electronic model of a custom medical mask, the three-dimensional electronic model suited for use with a rapid prototyping system; and one or more processing units coupled to the one or more memory units and operable to access the three-dimensional electronic model in the one or more memory units for use in connection with forming a custom medical mask for a particular user using the rapid prototyping system; wherein the three-dimensional electronic model of the custom medical mask comprises: a first surface that corresponds to unique facial features of the particular user; a model of a fitting configured to couple to a clinical gas delivery system; and a model of an oral chamber shaped to be offset from the mouth of the particular user when the custom medical mask is positioned on the particular user's face; and wherein the model of the fitting and the model of the oral chamber have been merged with the first surface.

34. A computer-implemented system for use in connection with forming a custom medical mask for a particular user from a three-dimensional electronic model, comprising: one or more memory units storing a three-dimensional electronic model of a custom medical mask, the three-dimensional electronic model suited for use with a rapid prototyping system; and one or more processing units coupled to the one or more memory units and operable to access the three-dimensional electronic model in the one or more memory units for use in connection with forming a custom medical mask for a particular user using the rapid prototyping system; wherein the three-dimensional electronic model of the custom medical mask comprises: a first surface that corresponds to unique facial features of the particular user; a model of a fitting configured to couple to a clinical gas delivery system; and a model of a coupling device shaped to couple the custom medical mask to an oral appliance; wherein the model of the fitting and the model of the coupling device have been merged with the first surface.