Customized Face Masks Made Using Additive Manufacturing

Abstract

A face mask including a base model of a mask body having a front side and a back side and defining an interior portion, the back side including a face opening into which a portion of a user's face, including the nose and mouth, can be inserted and encased, the face opening being defined by a perimeter and modified to substantially correspond to the contours of the user's face based on a scan of the user's topographical facial shape.

Description

[Technical field]

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 003,806, filed March 31, 2020, the contents of which are incorporated by reference in their entirety herein.

[0002] The present invention relates generally to face masks. More particularly, the present invention relates to 3D printed face masks. [Background technology]

[0003] Face masks, such as surgical face masks, are often worn by healthcare workers to protect themselves and their patients. Face masks can capture bacterial and viral particles that are dispersed from the wearer's mouth and nose during exhalation. The human face presents a challenge to forming a seal between the face mask and the face. The human face is deeply contoured, and the size and proportion of these contours vary greatly from one human face to another. However, face masks generally fit loosely, which allows bacterial and viral particles present in exhaled air to flow around the perimeter of the face mask, such as around the lower edges of the wearer's cheeks and chin.

[0004] Due to the more rigid nature of traditional 3D printed materials, traditional 3D printed face masks also fail to properly seal with the wearer's face. Additionally, the more flexible 3D printed materials available are less able to stretch, which puts them at risk of failing to seal when the wearer is talking, moving, experiencing temperature changes, or even changes in body moisture. [Prior art documents] [Patent documents]

[0005] [Patent Document 1] U.S. Patent No. 10,259,041 [Patent Document 2] U.S. Patent No. 7,188,622 [Patent Document 3] U.S. Patent No. 4,873,972 [Patent Document 4] U.S. Patent No. 5,509,436 Summary of the Invention [Means for solving the problem]

[0006] The present invention generally relates to a 3D printed mask for a respirator, customized to the user's face using a method to ensure a high quality seal. The mask may further be fabricated from a material that allows for cleaning and sterilization to make it reusable. The method captures a facial scan from a portable computing device, such as a mobile phone with a camera, a table, etc. The facial scan is converted into a facial model. The facial model is assessed for facial shape that allows for the creation of a custom contoured facial mask from a set of standard facial mask patterns. The patterns are selected and scaled to fit the user's face. The sealing contours of the mask are aligned and matched to the contours of the user's face to ensure a good seal. Alternatively, the facial scan is used to create a generative facial mask design that starts from the facial scan and builds a full custom facial mask model outwards. The present invention provides a better seal and improved comfort for the wearer compared to current designs.

[0007] In one embodiment, the invention generally includes a method for making a custom contoured facial mask, the method including scanning a wearer's face for facial scan data, evaluating the facial scan data, selecting a standard facial mask design from a library of patterns, scaling the selected pattern to a face size, aligning the selected pattern to the facial scan, merging the selected pattern to the face, and creating a contour corresponding to the face at a sealing edge of the selected pattern.

[0008] In one embodiment, the method further includes making modifications to the final custom contoured facial mask, such as, for example, providing a different contour profile, moving or otherwise repositioning anchor points on the facial mask, adjusting various insert features, such as, for example, a one-way exhalation valve, to relieve pressure on a user while breathing through the sealed mask, adjusting a filter cartridge design, or other features as may be desired, etc. The method may also further include exporting a 3D printable file that is usable by a 3D printer, enabling printing on the 3D printer with a set of build instructions for the printer, such as, for example, scanning procedures, part placement, etc., and printing the 3D printable file on the 3D printer.

[0009] In another embodiment, the invention generally includes a computer-implemented method for handling data collection, data conversion, data privacy, and data deployment, and matching scans with available printer capacity to enable distributed production of face masks quickly and efficiently.

[0010] In another embodiment, the invention includes a face mask comprising a generally cup or egg shaped mask body having one or more airflow openings. One side of the face mask is open and shaped to receive the mouth and nose shape of a human face. That side has a peripheral edge shaped to generally follow the contour of a human face extending around the mouth and nose area. The shape of the peripheral edge is most advantageously customized to the unique facial shape of the user. However, face masks can also be made with a variety of standardized facial shapes / contours that can be selected to best fit.

[0011] While it is contemplated that a face mask according to one aspect of the invention may not require any type of separate gasket-like element for sealing against the user's face, in one embodiment a flexible or otherwise pliable seal is bonded to, for example, the peripheral edge, which may extend around the entire peripheral edge or at least a portion thereof to allow for the necessary comfort and seal.

[0012] In one embodiment, the airflow openings include a filter material. One or more valves may be incorporated, such as at least one exhalation valve disposed in the mask body and having at least one orifice that allows exhaled air to pass through the mask body to the surrounding air. In one embodiment, at least one inhalation valve is disposed in the mask body and has at least one orifice that allows inhaled air to pass through the mask body for the user to breathe.

[0013] For purposes of facilitating an understanding of the subject matter sought to be protected, there are illustrated in the accompanying drawings, examples of which are set forth and by examining them and considering them in conjunction with the following description, the subject matter sought to be protected, its construction and operation, and many of its advantages, will be readily understood and appreciated. [Brief description of the drawings]

[0014] [Figure 1]FIG. 1 is an exploded perspective view of an exemplary face mask incorporating one embodiment of the present invention. [Diagram 2] FIG. 1 is an assembled perspective view of an exemplary face mask incorporating one embodiment of the present invention. [Diagram 3] FIG. 1 is a perspective view of an exemplary face mask incorporating another embodiment of the present invention. [Figure 4] FIG. 13 is a detailed perspective view of an exemplary face mask having user identification indicia incorporating another embodiment of the present invention. [Diagram 5] Figure 1 shows multiple face masks produced in a single build on an additive manufacturing (AM) machine. [Figure 6] FIG. 4 is a detailed perspective view of the face mask shown in FIG. [Figure 7] FIG. 4 is another perspective view of the face mask shown in Figure 3. [Figure 8] FIG. 4 is another perspective view of the face mask shown in Figure 3. [Figure 9] FIG. 13 is a perspective view of an exemplary filter compartment cap incorporating another embodiment of the present invention. [Figure 10] 1 is a flow chart illustrating an exemplary method of 3D printing a face mask incorporating an embodiment of the present invention. [Figure 11] 1 is a flow chart illustrating an exemplary method of customizing a face mask incorporating an embodiment of the present invention. [Figure 12] FIG. 1 is a functional schematic diagram of computer hardware for implementing aspects of at least some of the presently disclosed embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] While the present invention is susceptible of embodiment in many different forms, embodiments of the present invention, including preferred embodiments, are shown in the drawings and described in detail herein, with the understanding that the present disclosure should be considered as an exemplification of the principles of the invention and is not intended to limit the broad aspects of the invention to any one or more embodiments shown herein. In this specification, the term "the present invention" is not intended to limit the scope of the invention as claimed, but rather is used merely for illustrative purposes to discuss exemplary embodiments of the invention.

[0016] The present invention generally relates to face masks, such as face masks that can be used in surgical applications, but the invention is not limited to such uses. The face mask includes a custom-fit reusable mask body, one or more filtered openings, which may further include a valve, and an adjustable and removable strap system. Most preferably, the face mask invention is manufactured using additive manufacturing (AM) techniques, such as selective laser melting (SLS), fused deposition modeling (FDM), stereolithography (SLA), and the like. Another embodiment of the present invention is a method of capturing and using facial data to customize a face mask.

[0017] Additive manufacturing (AM) is well known as a general subject. See, for example, US Patent No. 10,259,041, the contents and teachings of which are incorporated herein in their entirety. With regard to the AM process and system of powder bed fusion, this relates to a manufacturing method for producing three-dimensional (3D) objects by depositing and selectively solidifying a build material, preferably a powder, layer by layer, comprising depositing a layer of build material in a build zone using a recoater, selectively solidifying the deposited layer of build material using a solidification device at points corresponding to the cross-section of the object to be produced, and repeating the depositing and solidifying steps until the three-dimensional object is completed. However, as described throughout this specification, the present invention applies beyond just powder bed fusion processes and may be implemented using any type of similar layer-by-layer manufacturing technique. Furthermore, it will be understood that the application of aspects of the present invention may be practiced outside of 3D printing.

[0018] 1-8, an exemplary face mask 10 incorporating one embodiment of the present invention is shown. The face mask includes a filter compartment 12 configured to receive a standard type filter element. A cap 14 is configured to close the filter compartment 12 and hold the filter element. The filter element may include a fabric layer 16, a perforated filter holder 18, and a main filter medium 20, as is well known in the art. The cap 14 includes a cap opening 22 configured to allow air to pass through the face mask 10. In one embodiment, the filter element includes a filter that may be certified as an N95 filter, an N99 filter, or any other NIOSH standard, such as, for example, a P100 or OV-100.

[0019] As described below, the face mask 10 includes a body 24 that is extruded based on a facial scan to create a contour 26 that conforms to the user's face. The body 24 includes a filter compartment 12, a cap 14, and a filter element. The contour 26 may be further profiled to create various edge shapes. For example, the contour 26 may be thinned to create a knife edge configured to be inserted into a seal 30 to provide additional resistance and cushioning to the contact area between the face mask 10 and the user's face. With reference to Figures 3 and 6-8, an exemplary contour 26 is shown inserted into a seal 30 that is not 3D printed. The seal 30 is constructed of a softer material than the body 24, such as a rubber or silicone seal 30.

[0020] In one embodiment, the seal 30 is comprised of an elastomeric material, such as a thermoplastic elastomer (TPE), a foam comprised of polyurethane, a combination of materials, such as a combination of TPE and ethylene-vinyl acetate (EVA) and / or polyurethane (PU), or any material suitable for forming an airtight seal between the user's face and the face mask 10. In another embodiment, the outer seal foam comprises polyurethane. Various contours 26 can be designed in the 3D printed face mask 10 to accommodate various types of seals 30. In another embodiment, the contours 26 are designed such that no intermediate material (i.e., the seals 30) is required. In one embodiment, the seals 30 are provided in only a portion of the contour 26, such as an area adjacent the bridge of the user's nose, and then tapered to contact the user's cheek below the nose area. The design of the contours 26 and the use of the seals 30 are a matter of facial geometry and comfort.

[0021] In one embodiment, the contour 26 is rounded into a teardrop shape, dumbbell shape, or other suitable shape that directly interfaces with the face and provides a softer impact against the skin while still allowing some movement (i.e., rolling, sliding) of the face mask 10 while still maintaining a seal. The contour 26 may have an "S-shape" that is processed using an AM printing process and a suitable polymer build material, such as PA2200, which is a standard polymer material in AM processes. The build material may have a wall thickness of about 0.4 mm and a suitable curvature that creates a biasing effect at the interface with the face, allowing the mask to move and flex to maintain a seal when the wearer moves their face or when the facial contour changes slightly due to blood pressure, skin moisture, temperature, etc. Additionally, this also reduces the pressure that the mask must be pulled to the face with an attachment mechanism, such as a strap. Variations in facial features may necessitate the need for different base shapes to fit a given population. The basic design may vary in areas such as flaring in the nose area to create space between the nose and the wearer depending on the contours of the face to allow for comfort and sealing of the mask. In another embodiment, the contour 26 may be a 3D lattice structure that also provides the biasing effect described above at the interface between the contour 26 of the mask and the face. Such a lattice structure is made from an elastic polymer material produced by AM, such as the Digital Foam line by EOS GmbH Electro Optical Systems.

[0022] The face mask 10 can be made from many different materials. Preferably, the material is selected to allow for a reusable mask shell, and therefore the material should have some properties that allow it to be washed and / or sterilized on some periodic basis. For example, PA2200 is a prime candidate for this application. PA2200 is a nylon-12 material that is well known in the additive industry for its qualities regarding high lot-to-lot uniformity from suppliers, as well as a good balance of physical strength, surface detail, and ease of processing in a 3D printer. Additionally, PA2200 has been evaluated for exposure to various pathogens, is sterilizable, can handle temperatures of 100°C to 140°C (the normal autoclave temperature range) without significant degradation, and is currently used in various medical device applications, including surgical cutting guides, with associated FDA approval, where it can be washed with soap and water. Additionally, PA2200 is easy to handle curves and other generally challenging physical profiles that can be produced with 3D printing. Thin, curved surfaces are particularly advantageous in that they give the mask some ability to flex when bent, as compared to sharp angles and corners, while at the same time making it easier for the wearer to clean.

[0023] In one embodiment (best shown in FIG. 8 ), a slight ridge or bead 36 is formed in the filter cap 14 or filter compartment 12 to allow for the use of alternative filter material. The bead 36 creates a shoulder that captures a tie-down element for attaching a filter element over the filter compartment 12. For example, the bead 36 allows for the use of a filter threaded into the mask, under the cap 14, or providing filter material over the opening of the compartment 12 and securing it with a fastener under the bead 36. This is particularly useful when filter material is in short supply when an alternative is needed. For example, an existing N95 cloth mask can be cut and the stub placed over the cap opening, then secured by a strap around and under the ridge or bead 36.

[0024] Referring to FIG. 9, the filter cap 14 includes a raised portion or bar 40 formed on the outside of the cap 14 for a user to manipulate to allow the user to remove the filter cap 14 while reducing the amount of contact the user must have with the remainder of the surface of the face mask 10. This feature is particularly useful in infectious disease environments where viral particles are present on surfaces. Thus, the raised portion 40 allows for easy removal and insertion. The cap 14 includes a threaded portion 38 configured to threadably mate with a corresponding thread in the filter compartment 12. The cap 14 may be fabricated simultaneously with the body 24 of the face mask 10 in an AM process.

[0025] 4, the face mask 10 includes a unique identifier 44 printed on the face mask 10. For example, the initials, name, and / or mask identification number of the user (e.g., doctor, nurse, clinician, etc.) that can enable cleaning, reuse, and tracking in a clinical environment, thereby reducing the risk of using someone else's mask, or even allow different mask numbers to be used only in certain patient environments, such as only for Patient A's room.

[0026] In another embodiment, the face mask 10 includes an exhalation valve, such as a one-way valve. The exhalation valve allows the exhaled air to bypass the filter by providing lower flow resistance, thereby providing greater comfort and reducing fogging caused by vapor. Examples of such devices include, for example, U.S. Patent No. 7,188,622, U.S. Patent No. 4,873,972, and U.S. Patent No. 5,509,436. Preferably, the one-way valve design will be applicable to operating room environments where exhaled products are filtered.

[0027] A 3D printer, such as those built and sold by EOS GmbH Electro Optical Systems as selective laser sintering (solidification) printers, has a certain amount of build volume available into which the part is placed for printing. The printer must also have instructions on how to build the desired part, such as how thick or thin each layer should be, how much laser power should be used, how the laser should scan the part (e.g., in what direction, how many passes, in what pattern, etc.), what temperature, recoating techniques, and various other general settings required to ensure the success of the resulting part. The operation of such printers is well known in the art and a detailed description thereof is not necessary herein.

[0028] The configuration of parts within a build, such as their placement, orientation, location next to each other, etc., can affect the quality of the final part in terms of feature fineness, part properties (mechanical and other surface qualities) and dimensions, as well as how fast or how many parts can be placed per run of the 3D printer.

[0029] Therefore, another aspect of the present invention is a build instruction kit created for a 3D printer to optimally print a face mask 10. This would include a build setup that can be automated, such a process including selecting the desired parts to be printed, importing the parts into a 3D printer CAD software environment, such as Magics® by Materialise®, and then allowing the software to automatically place and align the parts in an optimal manner following the rules and conditions set by the 3D printer operator or process developer. A possible outcome of such a setup is shown in FIG. 5. Having an automated process reduces the time required by the 3D printer operator to prepare the machine to print the part, thereby increasing productivity and improving the quality of the final part.

[0030] Referring to FIG. 10, a flow chart of a method 200 for handling data from a facial scan and 3D printing is shown. As shown in step 202, facial scan data is captured using a computing device such as a phone, tablet, computer, etc., via a software application such as bellus3D (www.bellus3D.com). The facial scan data includes a person's topographical facial features. As shown in step 204, the facial scan data is converted into a 3D object file and transferred for data exchange, such as via email.

[0031] The 3D object file is stored and / or converted into a printable face mask file. The facial scan data may include 3D model data such as a point cloud. Examples of file formats include, but are not limited to, STL, OBJ, FBX, COLLADA, 3DS, IGES, STEP, and VRML / X3D. Several elements of additional data (e.g., metadata) may also need to be transferred with the 3D object file. For example, user information (e.g., name, desired mask label, etc.), purchaser information, privacy acknowledgements and exchange rights to store the information or associated restrictions on its use, desired shipping information, and timing.

[0032] As shown in step 206, a facial mask design including a person's topographical facial features is created from the facial scan data. Additional calculations may be performed from the facial scan, such as comparing the face to a reference set of faces to understand symmetry and sizing that may affect the selection and design of the final customized facial mask. The facial mask design may be created using a computer aided design (CAD) application. CAD applications are well known in the art and will not be described in detail herein.

[0033] Then, finally, as shown in step 208, a printable file based on the facial mask design will be made available on the data exchange. As shown in step 210, the printable file may be made available to a purchaser, a user whose face has been scanned, and / or published on a marketplace for 3D printer owners to select and fulfill (print, verify quality, deliver) orders via a computing device capable of electronically communicating with the data exchange using known methods. Various order status information may also be handled by this data exchange platform. Although this embodiment is described with respect to face masks, the invention is not so limited and may be used to 3D print an array of other personalized products, such as, for example, gloves, glasses, helmets, prosthetics, clothing, etc.

[0034] Referring to FIG. 11, an exemplary method 300 for customizing a face mask incorporating an embodiment of the present invention is shown. One aspect of the method 300 is the capture and subsequent use of facial data to customize a face mask 10 or respirator. As shown in step 302, the method 300 includes capturing a topographical facial shape of a person in a facial scan using a computing device such as a phone, tablet, computer, etc., via a software application such as bellus3D (www.bellus3D.com). As shown in step 304, a facial mask pattern is selected from a database. As shown in step 306, the selected pattern is scaled to fit the size of the scanned face. The step of scaling the selected pattern may be accomplished by a user manually selecting a topographical facial shape using a user interface in a well-known manner. As shown in step 308, the selected pattern is aligned to the facial scan in a CAD environment. The selected topographical facial shape is used to align the selected pattern to the facial scan. The selected pattern is then merged with the scanned face, as shown in step 310. As shown in step 312, a custom facial mask file is created having a contour at the sealing edge of the mask that substantially corresponds to the topographical facial shape of the scanned face. The custom facial mask file may be modified, for example, by providing a different contour profile, moving or repositioning the selected topographical facial shape, adjusting various feature inserts, such as a one-way exhalation valve, adjusting the design of the filter cartridge or any other features as may be desired. As shown in step 314, the custom facial mask file is exported to a 3D printable custom contoured facial mask file that can be used (printed) by a 3D printer.Printing on a 3D printer is enabled by a set of build instructions (e.g., scanning procedures, part placement) for the printer in a well-known manner, as shown in step 316. The 3D printable custom contoured facial mask file is then printed by the 3D printer using AM techniques in accordance with the build instructions, as shown in step 318.

[0035] Similarly, the same basic methodology as the custom contoured facial mask described above can be used for what is called a generatable type of face mask. In this application, a facial scan is used to create an all-over generatable design. Thus, instead of selecting a facial mask pattern from a database as shown in step 304, this method uses a facial scan to provide a starting surface (plane) from which a software algorithm then develops a facial mask for that face, thereby creating an all-over custom facial mask design specific to the individual's face.

[0036] Such generatable facial mask designs can also incorporate "standard elements" such as filter cartridge holders, preferably in standard sizes, allowing for rapid mass production and efficient production of reusable elements such as filter materials, such as consumable cartridges that are replaced after a set number of uses. While generatable designs are known, current technology does not customize or personalize the final design to an individual's facial features. Rather, typical generatable designs are used for part manufacturing, custom product design, and even floor plan design.

[0037] By enabling digital build models and sets of instructions for 3D printers, distributed production models can be rapidly deployed and scaled up. For example, once a face mask print file is created and a set of instructions to run the printer is created, such data can be made digitally available (such as via the internet) to the physical location where the 3D printer is located. In this way, new models and designs can be rapidly deployed to production points. This is particularly useful in scenarios such as natural disasters or epidemics where supply chains and traditional logistics may be highly disrupted. For example, if digital build information can be deployed to an area along with a 3D printer, an item that may not otherwise be obtainable can be built locally, avoiding traditional supply chain hurdles. This type of additive manufacturing (AM) also enables the ability to modify designs very quickly, essentially in real time, to adapt to evolving needs.

[0038] For example, in the event of an infectious disease outbreak, digital build kits could be deployed to locations in outbreak hotspots, along with 3D printers and stockpiles of the appropriate raw materials, which could then be converted into the goods most needed.

[0039] Referring to FIG. 12, an example computing device 500 is shown in which an embodiment of the present invention may be implemented. It should be understood that the example computing device 500 is merely one example of a suitable computing environment in which an embodiment of the present invention may be implemented. Optionally, the computing device 500 may be any well-known computing system, including but not limited to a personal computer, a server, a handheld or laptop device, a multiprocessor system, a microprocessor-based system, a networked personal computer (PC), a minicomputer, a mainframe computer, an embedded system, and / or a distributed computing environment including any of a plurality of the above systems or devices. A distributed computing environment enables remote computing devices coupled to a communications network or other data transmission medium to perform various tasks. In a distributed computing environment, program modules, applications, and other data may be stored in local and / or remote computer storage media.

[0040] In its most basic configuration, a computing device 500 typically includes at least one processing unit 506 and a system memory 504. Depending on the exact configuration and type of computing device, the system memory 504 may be volatile (such as random access memory (RAM)), non-volatile (such as read only memory (ROM), flash memory, etc.), or some combination of the two. This most basic configuration is illustrated in the diagram below by dashed line 502. The processing unit 506 may be a standard programmable processor that performs the arithmetic and logical operations necessary for the operation of the computing device 500. The computing device 500 may also include a bus or other communication mechanism for communicating information between the various components of the computing device 500.

[0041] Computing device 500 may have additional features / functionality. For example, computing device 500 may include additional storage devices such as removable storage 508 and non-removable storage 510, including but not limited to magnetic or optical disks or tapes. Computing device 500 may also include network connections 516 that allow the device to communicate with other devices. Computing device 500 may also have user input devices 514, such as a keyboard, mouse, touch screen, etc. Output devices 512, such as a display, speakers, printer, etc. may also be included. Additional devices may be connected to the bus to facilitate communication of data between components of computing device 500. All of these devices are well known in the art and need not be discussed at length here.

[0042] The processing unit 506 may be configured to execute program code encoded in a tangible computer readable medium. Tangible computer readable medium refers to any medium that can provide data that causes the computing device 500 (i.e., machine) to operate in a specific manner. A variety of computer readable media may be utilized to provide instructions to the processing unit 506 for execution. Example tangible computer readable media may be implemented in any manner or technology and include, but are not limited to, volatile, non-volatile, removable and non-removable media for storing information such as computer readable instructions, data structures, program modules, or other data. The system memory 504, the removable storage 508, and the non-removable storage 510 are all examples of tangible computer storage media. Example tangible computer-readable recording media include, but are not limited to, integrated circuits (e.g., field programmable gate arrays or application specific ICs), hard disks, optical disks, magneto-optical disks, floppy disks, magnetic tape, holographic storage media, solid state devices, RAM, ROM, electrically erasable program read-only memory (EEPROM), flash memory, or other memory technologies, CD-ROM, digital versatile disk (DVD), or other optical storage devices, magnetic cassettes, magnetic tapes, magnetic disk storage devices, or other magnetic storage devices.

[0043] In one example implementation, the processing unit 506 can execute program code stored in the system memory 504. For example, a bus can carry data to the system memory 504, from which the processing unit 506 receives and executes instructions. Data received by the system memory 504 may optionally be stored on a removable storage device 508 or a non-removable storage device 510 before or after execution by the processing unit 506.

[0044] It should be understood that the various techniques described herein may be implemented in connection with hardware or software, or combinations thereof, where appropriate. Thus, the methods and apparatus of the presently disclosed subject matter, or certain aspects or portions thereof, may take the form of program code (i.e., instructions) embodied in a tangible medium, such as a floppy diskette, CD-ROM, hard drive, or any other machine-readable storage medium, which when loaded into and executed by a machine, such as a computing device, makes the machine an apparatus for practicing the presently disclosed subject matter. In the case of executing program code on a programmable computer, the computing device generally includes a processor, a processor-readable storage medium (including volatile and non-volatile memory, and / or storage elements), at least one input device, and at least one output device. One or more programs may implement or utilize the processes described in connection with the presently disclosed subject matter, for example, through the use of application programming interfaces (APIs), reusable controls, or the like. Such programs may be implemented in a high level procedural or object oriented programming language to interact with a computer system. However, the programs may also be implemented in assembly or machine language, if desired. In any case, the language may be a compiled or interpreted language, and combined with hardware implementations.

[0045] The matter set forth in the foregoing description and accompanying drawings is offered by way of illustration and not by way of limitation. While particular embodiments have been shown and described, it will be apparent to those skilled in the art that changes and modifications may be made therein without departing from the broader aspects of the inventors' contribution. The actual scope of protection sought is intended to be defined in the following claims when the appended claims are viewed in their proper light based on the prior art.

[0046] Those skilled in the art will understand that the terms used in this specification in general, and in the appended claims in particular (e.g., features of the appended claims), are generally intended as "open" terms (e.g., the term "including" should be interpreted as "including, but not limited to," the term "having" should be interpreted as "having at least," the term "include" should be interpreted as "including, but not limited to," etc.). Furthermore, those skilled in the art will understand that where a specific number of introduced claim recitations are intended, such intent will be expressly set forth in the claim, and in the absence of such recitation, no such intent exists. For example, as an aid to understanding, the following appended claims may include the use of the introductory phrases "at least one" and "one or more" to introduce claim recitations. However, even when the same claim includes the introductory phrase "one or more" or "at least one" and an indefinite article such as "a" or "an," the use of such phrases should not be interpreted as suggesting that the introduction of a claim statement by the indefinite article "a" or "an" limits any particular claim that includes the claim statement so introduced to embodiments that include only one such statement (e.g., "a" and / or "an" should normally be interpreted to mean "at least one" or "one or more"). The same applies when a definite article is used to introduce a claim statement. In addition, those skilled in the art will recognize that even when a specific number of introduced claim statements is explicitly recited, such a recitation should normally be interpreted to mean at least the recited number (e.g., the recitation "two statements" alone, without any other qualifier, normally means at least two statements, or more than two statements).Furthermore, when a notation similar to "at least one of A, B, and C, etc." is used, such a structure is generally intended in the sense that a person skilled in the art would understand the notation (e.g., "a system having at least one of A, B, and C" would include, but is not limited to, a system having only A, a system having only B, a system having only C, a system having both A and B, a system having both A and C, a system having both B and C, and / or a system having both A, B, and C, etc.). When a notation similar to "at least one of A, B, or C, etc." is used, such a structure is generally intended in the sense that a person skilled in the art would understand the notation (e.g., "a system having at least one of A, B, or C" would include, but is not limited to, a system having only A, a system having only B, a system having only C, a system having both A and B, a system having both A and C, a system having both B and C, and / or a system having both A, B, and C, etc.). Moreover, those skilled in the art will understand that virtually any disjunctive word and / or disjunctive phrase presenting two or more alternative terms, whether present in the specification, claims, or drawings, should be understood to contemplate the possibility of including one of those terms, either of those terms, or both terms. For example, the phrase "A or B" will be understood to include the possibilities of "A" or "B," or "A and B."

[0047] It is to be understood that the logical operations described herein with respect to the various figures may be implemented (1) as a series of computer-implemented acts or program modules (i.e., software) executing on a computing device (e.g., the computing devices described in the figures below); (2) as interconnected machine logic circuits or circuit modules (i.e., hardware) within a computing device; and / or (3) as a combination of software and hardware in a computing device. Thus, the logical operations discussed herein are not limited to any particular combination of hardware and software. The implementation is a matter of choice that depends on the performance and other requirements of the computing device. Thus, the logical operations described herein are variously referred to as operations, structural devices, acts, or modules. These operations, structural devices, acts, and modules may be implemented in software, firmware, special purpose digital logic, and any combination thereof. It is also to be understood that more or fewer operations may be implemented than shown in the figures and described herein. These operations may also be performed in a different order than described herein.

Claims

1. A method of making a face mask, comprising: capturing topographical facial features of a face during facial scanning using a portable handheld device; exporting the facial scan to a processing center; selecting a facial mask pattern from a database maintained by the processing center based on demographic characteristics of the person using the face mask; scaling the selected facial mask pattern to a size of the face; aligning the selected facial mask pattern to the face; merging the selected facial mask pattern with the face; creating a custom facial mask file for the face mask having a contour at a sealing edge of the face mask that corresponds to the topographical facial shape of the face and covers the person's nose and mouth; exporting the custom facial mask file into a 3D printable custom contoured facial mask file usable by a 3D printer; A method comprising:

2. The method of claim 1 , further comprising the step of modifying the custom facial mask file.

3. 10. The method of claim 1, further comprising inputting the 3D printable custom contoured facial mask file into an operating system of an additive manufacturing system and operating the system to producibly build the face mask.

4. The method of claim 3 , wherein the additive manufacturing system is a powder bed fusion 3D printing process.

5. The method of claim 1 , further comprising providing a flexible seal configured to receive a portion of the contour.

6. 1. A computer-implemented method for making a face mask, comprising: receiving a topographical facial shape of a face captured in a facial scan using a portable handheld device; exporting the facial scan to a processing center; selecting a facial mask pattern from a database maintained by the processing center based on demographic characteristics of the person using the face mask; scaling the selected facial mask pattern to a size of the face; using the scaled selected facial mask pattern to create a custom facial mask file for the face mask having a contour at a sealing edge of the face mask that corresponds to the topographical facial shape of the face; exporting the custom facial mask file into a 3D printable custom contoured facial mask file usable by a 3D printer; 4. A computer-implemented method comprising:

7. The method of claim 6 , further comprising providing a flexible seal configured to receive a portion of the contour.

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