3D Printing – Leslie Oliver Karpas, Robert William Moore, Rem Sleep Medicine Pc
Abstract for “Customized medical equipment and apparel”
“Systems and methods of making a custom sleep-apnea mask are disclosed. The sleep apnea device comprises a mask for the face, a headband that is integrally connected to it, and at most one air duct to direct the air from the CPAP machine into the nasal tubes. The face mask should have an inner surface that is the same as the user’s facial shape, an upper surface that sits at a predetermined distance between the eyes and the nose, and an outer surface that extends a predetermined distance from this inner surface. The mask’s shape and position are nearly identical for all surfaces. This allows the patient to create a mask that is customized to their needs.
Background for “Customized medical equipment and apparel”
Sleep apnea is a condition that affects millions of people. It occurs when someone’s breathing pattern is disrupted while asleep. This condition can cause people to feel tired during the day and disrupt their sleep patterns at night. Air delivered via continuous positive airway pressure is a common treatment for sleep apnea. The machine delivers air using a mask that fits around the nose, nose, and mouth of the patient. The mask must be worn while the patient sleeps in order to be effective. In order to keep the pressure seal, the mask usually has rubber and plastic components. The current sleep apnea masks can be adjusted to fit a wide range of faces and sizes. Current sleep apnea masks are not designed to fit all patients. They may also be difficult to wear, have weak pressure seals, or may feel uncomfortable. To improve functionality and comfort, a custom-fitted sleep apnea mask is needed. This will increase the likelihood that the patient will be able to receive long-term successful treatment.
The preferred embodiment of the invention features a system for making a wearable article, such as a custom sleep apnea device that can be used with a CPAP machine. The preferred method involves scanning at least one portion of the user’s head; creating a surface model of his face; and identifying a set facial features using the surface model. A first point corresponds to the user?s nose and a second point corresponds to the user?s lips. The surface model generates a first contour based upon the first point. A second contour is generated based the second point. A third contour can be generated at an interposed position between the first contour and the second contours, offset from the user’s nostrils. Method 2 also includes creating an outer surface of a mask that contains the first, second and third contours. The inner surface of a mask is generated by the method between the second and first contours. Combining the inner and outer surfaces can create a 3D volume for a sleep apnea mask that can be printed with one of many 3D printers. Some embodiments combine the surface model for the user’s head with the surface model for a generic head to create a complete data set that can be used to generate a complete head mask.
“Another embodiment of the invention includes a sleep apnea machine that can be used with a CPAP device. The system includes a face mask and a headband connected to it. At least one air duct is also included to direct the air from the CPAP machine into the nasal tubes. The face mask should have an inner surface that is the same as the user’s facial shape, an upper surface that sits at a predetermined distance between the eyes and the nose, and an outer surface that extends a predetermined distance from this inner surface. To attach the CPAP machine to the pliable coupling, and to attach to at least one of the air ducts, a pliable coupling can be used. You can have an internal duct embedded within the headband or an external tube with flexible tubes attached to it.
“In some embodiments, an article custom made by the invention is provided. This involves providing user scan data that corresponds to a user’s face, providing generic data that corresponds to a portion of a head, and providing model data that corresponds to a sleep apnea or other article. The method also includes the creation of a model of the head and face by combining the user scan data with generic model data. The model data for the sleep apnea snoring mask is then fitted to the model of head and face based on user’s nose, mouth, or other anatomical characteristics. The model data of a mask is then matched to the model of the head and face to create a mask that fits the user’s head. This mask model can then be sent to a 3D printer to create the custom mask. The head and face are only two examples of the many body parts that user scan data can be combined with generic model data to create custom medical devices, apparel or other wearable articles.
“Illustrated at FIG. 1. is a functional block diagram for a network that implements one or more embodiments according to the present invention. A Dynamic 3D Printer Design System (DPDS 130) is part of the network that can be used to create medical devices and other custom-fitted parts. The preferred embodiment of the medical device is a sleeping apnea-mask, but the DPDS can also produce other medical and non-medical devices, such as eyewear, goggles and ski masks, scuba and footwear masks, and other apparel. To ensure comfort and superior fit, each mask is custom-made based on 3D scan data. This improves the effectiveness of the treatment and masks. These masks can be made using a variety of manufacturing techniques, such as one or more 3D printers 120-122, or other rapid prototyping or computer-aided manufacturing techniques.
“The data from the patient scans can be obtained using any one of many scanning systems that are available to those who are skilled in this art. Scanners such as the 3D Systems, Inc., Rock Hill, S.C., can be used to collect data points in a Euclidean three-dimensional space. A technician 110 may acquire the scan data from a patient 112 using a scanner 110, which is located in a clinic, pharmacy, hospital, or retail location. Another embodiment allows the user to acquire the scan data using a personal scanner 114. The preferred embodiment of scan data consists of 3D volume data that characterizes the shape, size and contours the head and/or faces of the patient in a three-dimensional coordinate system, such as a Cartesian or polar coordinate system. You can either store the scan data as point clouds or convert it to a surface model using one of the following formats: sub-divisional NURB data, non-uniform rational NURBS (aka sub-dNURBS), and/or a combination of parametric definitions. Common file types for representing scan data include mesh file types: .mud/.mb/.anim/.iff/.cpp/.fxa/.spt/.c4d/.aec/.exr/.mc4d/.3ds/.max/.act/.bip/.cel/.exr/.ztl/.stl/.ply/.amf; NURBS file types: .lxo/.blend/.blend2/.obj/.off/.mdd/.exr/.sdl/.wire/.3dm/.3dx/.ws/.3dc; and parametric file types: .dgn/.dgr/.rdl/.svf/.dwg/.dxf/.adsk/.ies/.rvt/.skp/.easm/.dwf/.dwfx/.iam/.idw/.ipt/.drw/.dxf/.jt/.lay/.prt/.sec/.slp/.stl/.drw/.dxf/.jt/.lay/.prt/.sec/.slp/.3dmap/.3dxml/.c18/.catpart/.catshape/.model/.sldprt/.sldasm/.tso/.xli/.scdoc/.ad_prt.”
“The DPDS 130 processes the patient’s scan data to create a medical device. Depending on the application the DPDS 130 can be located in the same place as the scanner or remote at a different facility via the Internet 102. The preferred embodiment of the DPDS 130 contains a product interface 132 and computational geometry processor 134. Fabric controller 136 is also included. Scan data database 138 is also included. The product interface 132 can be used to select and determine one of several medical devices or components that will be generated using the scan data. The computational geometry processor (CGP134) is used to clean the scan data from artifacts and to fit a generic model to the scan data. It then generates a custom-fit mask for each patient. The fabrication geometry processor FGP 136 converts the data representing the customized mask into one or several?.STL? Files and/or other manufacturing instructions that are specific to the 3D printers 120-122 chosen/used to make the custom mask. The DPDS 130 may also include a biodata interface 140 that allows patients to access their personal physiological or biological data 140 in order to modify the size, shape or functionality of the mask.
“Illustrated at FIG. 2. This is a flowchart showing the process of creating a custom-fit sleeping apnea or medical device. After taking a 3D scan 210 of the patient’s head and face, 212 is chosen from a variety of mask types. A digital model of the mask is created from the selected mask type. The patient’s scan data is used to create a digital model of the mask. This will result in a mask that provides maximum comfort and a reliable seal. The mask model is modified to create 216 data files and computer instructions that are used to build or modify 218 the mask custom-fit for the patient.
“Illustrated at FIG. 3. The product interface according to the preferred embodiment shown in FIG. 1. The mask selection processor 310 is part of the product interface 132. It allows a technician to select a sleep apnea syringe from a variety of options. These include (1) a nasal mask that can attach to and receive continuous positive airway pressure (CPAP), (2) a mask for the mouth and nose with a CPAP attachment and (3) a mask equipped with nasal tubes with CPAP attachment and (3) a mask with tubes and valves. A CPAP attachment masks generally have a coupling and one to several integrated air ducts that connect the sleep apnea device with the pressurized CPAP output. These one or more air conduits may be embedded in the mask, or set of elastic tubes that are routed outside to a mask headband.
The tube selection processor 320 allows you to choose between embedded or external ducting options, if they are available. The technician can choose from a variety of attachment mechanisms to connect directly to the CPAP output tube to the mask using the pneumatic coupling selection 330. There are many attachment mechanisms that can be used to connect the mask and CPAP output tube. They all have different couplings, which correspond to different sizes, shapes, or locations on the patient?s head. The patient fitting processor (340) allows the technician to adjust and fit the mask model to the patient. The preferred embodiment does not require any manual adjustments. However, the interface 132 allows the technician to adjust the size and position of the mask and the headband to suit the patient’s sleeping habits. To avoid interfering with patient’s eyes and ears, the location of the headband can also be changed. The module for attachment selection 350 allows the technician to modify the mask model to include alternative mechanisms to attach the mask to the patient. For example, one or more magnets, or shape-changing alloys, may be placed into the mask to create a force that biases it against the patient’s face. The customization processor 360 allows the modification of the mask model to include stylistic and aesthetic design features such as colors, graphics and embossing.
“In certain embodiments, the product interface also includes a processor (370) for customizing masks based on personal diagnostic measurements (PDM). PDMs can include information about the airflow capacity and anatomy of the patient’s esophagus (determined using magnetic resonance imaging (MRI), scan data, or x-ray scans data, e.g. This data can be used to determine the size and shape optimal for the air ducts of the sleep apnea mask. The air passages of the sleep apnea Mask may be expanded to allow maximum air flow to compensate for difficulty breathing, such as a blocked nose.
“Illustrated at FIG. “Illustrated in FIG. 1. CGP 134 can receive both the mask model and patient scan data from the product interface 132. Before merging the mask model with the scan data, artifacts must be identified and removed using an artifact elimination module 410. Patients’ hair can cause significant artifacts by not scanning well. This results in gaps in the data set and incorrect scan points. CGP 134 also includes a manifold integration processor 420. This is used to convert patient scan data to a surface manifold, if it is not already. It then removes any holes or apertures from the manifold that could prevent or interfere in the production of the mask model, or 3D printing operation.
“Some embodiments of the patient scan data consist of a manifold that represents the face. This generally covers the area from the forehead down to the chin, and the region from ear to toe. The embodiment may require scan data that only represents the face to create a sleep apnea or compliance mask. The CGP 134 has a processor 430 that can combine the face data with a generic head model to create a complete model of the patient’s head. FIGS. 5A-5C show the process of merging and/or otherwise combining head data and face data. 5A-5C. The preferred embodiment shows the face data as a 2D surface in FIG. 5A and FIG. 5B, respectively. 5B. 5B. Transitions between the head model and face data should be smooth, proportionate, and consistent at the borders. The gaps between the head and face manifolds can be filled with any of the many surfacing techniques, such as lofting. As shown in FIG. 5, the result is a single surface, including head and face, that represents each patient’s head. 5C. 5C.
“In some instances, the head data that is to be combined with the face data are selected from a variety of generic head models. To provide a variety of models to represent different body shapes and proportions, a database may contain a number of generic head models. Patients may choose their own head models based on their ancestry, gender and age. The face data can be merged with the best model by testing several candidates. The preferred embodiment of the optimal head model is the one that produces the least geometric error. This means that it is the model that gives maximum tangency between the face data and the head data. Maximal tangency refers to the minimum rate of curvature change at the boundary of the head and face data. This is averaged across the entire boundary.
“The feature identification processor 440 then locates one or several anatomical features (e.g. eyes, nose, mouth and ears) in the model of the patient’s head. These features are used as control points to automatically align, register, fit, shape, and/or design the customized mask model. The control point fitting processor (450) is used to adjust the size, orientation, and/or position of the mask to fit around the nose and mouth. It also allows the operator to adjust straps or other external air ducts, if any, to adjust the position above and below the ears.
“In one preferred embodiment, a model of the mask has been constructed using a technique called “Boolean Volume Subtraction.” FIGS. 6A-6C. The volume subtraction technique involves superimposing a 3D mask model and the 3D volume of a patient’s head and subtracting a portion from the mask model. Particularly, the 3D mask model (510) in FIG. 6A extends or protrudes into the interior space of model 520 of FIG. 6B to ensure that both models overlap in the area of the straps and face. After aligning the mask and patient scan data, a compliance determination process 460 removes the part of the mask model that interferes with the interior of the head model. The mask 530 remains is a custom mask with an inner surface that matches the patient’s face. Each patient is different, so each mask model is also unique. In FIGS, we also discuss other techniques to create a custom-fit mask. 8A-8F and 9A-9D.”
“Illustrated at FIG. FIG. 7 shows the fabrication geometry processor (FGP136) in accordance to the preferred embodiment of DPDS 130. 1. Using the FGP 136, a technician chooses a manufacturing method or system for one or more components. Direct 3D printing one or more components of the mask and/or 3D printing a mold from which some or all of the mask components can be cast may be used. The user has the option to build the mold or portion of the mask using stereolithography (SLA), 720, fused-deposition modeling (FDM), 730, fused filament fabricat (FFF), starch based printing system 740 and selective laser sintering 750. Printing 760 and/ENVISIONTEC? 3D printing. After selecting the manufacturing methods, the FGP136 converts the customized mask model into one or several print files, manufacturing instructions and/or assembly directions specific to the chosen 3D printer. It generally involves the creation of one or more?.STL files. Files from the parametric solids (mesh) or non-uniform rational b-spines data models (NURBS).
“In addition, the?Boolean Volume Subtraction? The custom-fit mask can be made using any of the techniques mentioned above. technique, or (b) a parametric fitting? FIGS. 8A-8F and (c) a “press fit?” FIGS. 9A-9D. 9A-9D. The?NURBS subtraction? technique converts the mesh model of the patient (including the combination data of head and face data) to a nonuniform rational basis spiral (NURBS). The mask model, also known as NURBS, can be superimposed on top of the NURBS patient model. As mentioned above, the mask’s size, position, or proportions can be altered to accommodate anatomical features detected by the feature identification processor (440). Once the head and mask models have been aligned, the compliant version is generated from the intersection of NURBS mask and patient. The NURBS portion of a patient model that is bounded by the mask model are identified. Also, the NURBS portion of a mask model that lies outside of the patient model’s boundary is identified. The NURBS section of the patient-model is the area between the upper and lower edges of masks where patient and patient models intersect. The NURBS section of the mask is the portion of the model that extends outwards from the patient model. The NURBS surface of each portion is combined to form a NURBS volume that represents a compliant mask. The fabrication geometry processor then processes the NURBS volume in the following manner.
“In the?parametric fit? FIGS. FIGS. 8A-8F illustrate the custom-designed mask and its interior volume. This technique is different from other techniques that only the mask’s inner face can be customized for each patient. The present embodiment has three parts: (a) the inner face of the mask; (b) its interior structure and (c) its outer surface. These are custom-designed for each patient to optimize fit and airflow, minimize material consumption, and/or reduce the size of the mask. The parametric fitting process involves measuring or locating points on the user’s face in three dimensions. The mask shape is then determined relative to these points. Parametric fitting ensures that each patient’s mask fits regardless of their height, width, or overall size. This is in spite of differences in age, gender, and ethnicity.
The preferred embodiment of the parametric fitting process for designing the mask starts with the acquisition and recognition of features as well as the 3D head model. After determining the location of the eyes and nose, the mask design system will locate the following anatomical points from the scan data of the patient: (a) The tip of your nose 810; (b) The bridge of your nose 812 between the eyes 814; (c) The uppermost point of your lips 816 closest the nose; (d) The underside of nose 818 closest the upper lip; (e) The width of your face 822, 824 and (f) Center points of the nostrils 820. These points will vary from one patient to the next. The mask design system uses the scan data to determine the best location for the (a) upper edges of masks, (b) shape of upper edges of masks, (c) bottom edges of masks, (d) shape of bottom edge masks, and (e) height of mask off the face across the whole face.
“First, the mask fitting device 450 locates the point approximately half-way between the tip and bridge of your nose. This point is referred to as the mid-nose location 830. This point, in the preferred embodiment, is 60% of distance between tip and bridge measured from the tip. The upper edge of mask is then anchored at the mid-nose point. The mask’s desired shape is then created by fitting a predetermined curve 832 between the mid nose point and the left 822 side of the face. The projections of the curves that span the left and right sides are made in one plane. A contour in 3D space represents the intersection of the projections of the curves with the scan data. The mask’s upper edge is located by the first contour 840.
Third, the mask system finds a point approximately half-way between the nose and lips. This point is referred to as the philtral Dimple Point or simply dimple point 834. This point corresponds to 40% of the distance from the upper tip 816 on the upper lips to the lower end of the nose, measured from the upper mouth. The lower edge of the mask is then anchored by the dimple point 834. A point below the lips can be used to cover both the nose or mouth instead of the 834 dimple point. A fourth predetermined curve 836 that defines the desired mask shape is fitted between the dimple nose tip and the left side 824 and the right side 824. This measurement determines the facial width. The projection of the curves that span the left and right sides are done in one plane. A contour in 3D space represents the intersection of the projections of the curves with the scan data. This second contour 842 marks the lower edge of mask. FIG. 841 illustrates the portion of 3D patient data that lies between the first contour (840) and the second contour (842). 8C.”
“Fifth, a mask offset delineating the forward-most edge is determined using a?tween contour. FIG. 844 8D. The tween contour can be calculated by (1) creating a 2D curve by adding the vertical heights of the upper contours 840.842 to the patient’s head data; (2) projecting the 2D curve onto the patient’s head data to generate a 3D curve; (3) creating an offset curve by taking the 3D curve coinciding in with the scan data, and then adding a fixed offset distance in front of the face; (4) generating final tween contour 844 through smoothing or by filtering the edges. You can adjust the offset distance to match the height of your mask, to a particular wall thickness, or to a distance beyond the tip.
“The foundations of a number of cross section curves are laid on top of the upper and lower contours 842, 840, and 842. The final tween contour 844 is used to create the outer surface of a mask. FIG. 8E shows the cross section curves. 8E shows the general cross section at different points along the length of the mask. A cross section curve, which is a line that intersects the upper, lower, and final tween contours 842 and 840 at each point along the length, can be found at every point along the width. The plane projects roughly at a right angle to the intersection of the upper contour. This creates the outer surface 860 of a mask by including each cross section curve.
“The mask’s outer surface 860 is not the only thing that needs to be determined. The mask’s inner surface can also be determined by the contours of its upper and lower surfaces. The upper and lower contours can be used to segment the relevant sections of patient’s head scan data or face scan data 860 shown in FIG. 8C. 8C.
“In some embodiments, the initial form defined by the outer and inner surfaces acts as a template for other mask features such as nasal tubes, hose connections and clips. The preferred embodiment of nasal tubes is also designed according to anatomical points, such as (a) the centers points of the nostrils, (b) the tip of the nose, and (c), the bridge of the mouth 812. The nasal tubes are concentric around the nostrils’ center points. In particular, the orientation of nasal tubes is parallel with the line connecting the bridge of 812 and tip of 810.
“Another embodiment of the mask uses the “press fit” design technique. FIGS. 9A-9D. The mask is created by adapting or morphing a generic mask onto patient scan data. The mask is created by a generic 3D model. It is then scaled, rotated and vertically aligned at an area in front of the scan data. This position uses the anatomical features as well as various points, including the dimple point 834 and mid-nose point 830. The mask model is placed next to the scan data. This is done by aligning the upper and lower edges of each mask vertically with the mid-nose and dimple points. In FIG. 9B, the mask model 910 is located adjacent to the scan data 930. 9B, and in cross-section in FIG. 9C. Second, the mask model 901, which is located in front of the scan 930, is mathematically pressed onto the face or stretched so that the mask’s inner surface 920 takes on the shape of scan data 930. FIG. 9C shows the generic mask before pressing. 9C, and the custom mask 912 that is created after pressing are shown in FIG. 9D. 9D. For manufacturing, the final mask model can be sent to the printer.
“Illustrated at FIGS. FIGS. 10A-10N show a first embodiment for a sleep apnea machine. It includes a face mask 1000 that is aligned with the patient’s nose and a headband 1010. The mask is secured to the face using air ducts 1020. This allows for the CPAP machine pressurized air to be channeled to the mask. A pair of nasal tubes may be included in the face mask to channel air directly to the nose. There may also be one or more connectors or manifolds 1002 to connect the air ducts and nasal tubes. In the preferred embodiment, the air ducts 1020 are made of vinyl or polycarbonate tubes and run along the back of your head to the face mask. The polycarbonate tubes can diverge from the head, where they connect to a single coupling that detachably attaches to the CPAP machine’s output tube. This multi-tube coupling 1030 is sometimes referred to as a “spider coupling”. FIGS. 17A-17D. 17A-17D. The headband 1010 is usually made from flexible material such as silicone. The headband can be attached to the patient’s back using a fastener such as a clip, button or strap.
“The inner face 1060 and the headband of the mask are designed to fit the patient’s face. The size and spacing of each pair of nasal tubes are tailored to the needs of the patient who will be using the mask. The mask and headband can be customized for each patient based on scan data. There are no two masks that can be identical.
The mask should be sized to fit the patient’s face. It should have a flexible and a rigid section. For example, the flexible portion that comes in contact with patient’s faces may be made of bio-safe rubber or silicone. The rigid portion of the mask could be made of a plastic that can be built layer by layer using one or more rapid prototyping or computer-aided manufacturing methods, such as those discussed herein. FIGS. FIGS. 10J and 10K show the facial portion of the mask, which includes a base plate as well as left and right manifolds 1002, shown in FIGS. 10L to 10N A manifold is an enclosed cavity that contains (1) multiple input holes 1004 to receive the end of each polycarbonate tub 1020 and (2) an outhole 1006 to channel air into one or more of the nasal tubes. Each manifold is designed to fit into the base plate and friction fit onto it.
“Like the mask the inner face 1060 may be made of silicone or another elastomeric material. It is flexible and comfortable for the patient’s skin.
Referring to FIG. 10D. The mask contains nasal tubes 1050, which are designed to reach a small distance into the nose of the patient. FIG. 10F shows the nasal tubes in cross section. 10F, and FIG. 10G. The preferred embodiment of the nasal tubes is made from an elastomeric material. The nasal tubes can expand slightly in the nose when positive air pressure is applied to them. This allows the tubes to better fit the patient’s nose while maintaining the pressure induced from the CPAP machine.
Referring to FIG. “Referring to FIG. Magnets can be embedded outside of the nose or inside the nasal tube to create a gentle pinching force to hold the mask on the patient’s head. The preferred embodiment includes the cavities that can receive magnets or ferrous material in the model of mask, as well as the magnets/ferrous materials that are inserted after production.
“In FIGS. FIGS. 11A to 11F show a second embodiment of the sleep apnea mask. It uses the polycarbonate tube 2020 to attach the mask 2000 to the patient’s forehead without any underlying strap or band. The face mask has a base plate 2060, a conformal inner layer, nasal tubes 1050 and manifolds 2002 that are coupled to the polycarbonate tube. The base plate 2060’s inner surface has a recess that conforms to the patient?s nose. The tubes that make up an air duct are attached to multiple retainers 2040. These retainers have channels into which the tubes can seat. This is different from the previous embodiment. FIG. FIG. 11F receives a number of tubes from the CPAP fitting 2030 and divides them using the guide holes 2046. The tubes are held in place by a second and third set 2040 of retainers 2040. They travel from the patient’s cheek to the face mask using channels 2042. Additional channels 2022 are included in the face mask 2000, into which the tubes can be seated. This is a fourth set. The length of the tubes connecting the face mask to the first retainer determines the location of the mask. The patient can adjust the position of the mask by simply retracting the tubes from the first retentioner or inserting the tubes into the second retainer.
“In FIGS. FIGS. 12A-12B show a third embodiment of the sleep apnea mask 3000. It is substantially the same as the mask 1000 in the first embodiment, but with an enclosure 3004 covering a portion the nose and mouth. The manifold (not illustrated) is used to blow air into the nasal tubes 1050 and the enclosed 3004 covering the mouth. This helps maintain pressure in the patient?s respiratory system. Vent holes 3006 allow air to escape the enclosure if the patient sneezes. The third version of the mask, like the first, includes a headband to secure the mask to the face as well as external air ducts to channel pressurized air from CPAP machine to mask.
“Illustrated at FIGS. FIGS. 13A to 13J show a fourth embodiment for a sleep apnea machine. It includes a face mask 4000 that coincides with the patient’s nose, a 4010 headband, and one or several air ducts 4020 which channel pressurized air from CPAP machine to mask. The coupling 4030 is a tube-shaped device that conducts air from CPAP machine to headband air ducts. FIGS. 17A-17D. 17A-17D. The internal air ducts 4020 are embedded within the headband4010. They run from the back of your head to one or both faces, then on to the nasal tubes 4050 inside the mask. FIG. 13H shows a cross-section of the air ducts. FIG. 13H shows a cross-section of the air ducts, while FIG. 13I shows a cross-section of the cavity and face mask. 13I. 13I. There are a number of panels 4002 that can be snapped in and frictionally fitted to the enclosure. The right and left portions of the 4010 headband include caps or panels 4012 which snap in and frictionally attach to the headband. These panels, or caps 4002 and 4012 allow access to the cavity and air ducts for the purpose of removing any support material that may have been deposited during manufacturing.
“The nasal tubes 4050 could contain a cavity in which a magnet 4052 can be inserted. In close proximity to the nasal tubes 40550, a cavity and a magnet 4052 have been created in the enclosure.
The headband 4010 is usually made from flexible material, where it touches the skin of the patient. The headband can be attached to the patient’s back using a fastener 4014 or clip, strap, magnet, or strap.
“According to the invention, the inner faces 4060 and inner faces of the headband of the face mask are designed to fit the patient’s face. The mask and headband can be adjusted to suit the patient. The mask and headband for sleep apnea devices are customized to the patient’s needs, as they are based on scan data. For example, the inner face of the headband and mask may be made of flexible elastomeric materials such as silicone. The outer part of the headband and mask may be made of plastic that can be built layer by layer using one or more computer-aided production systems, such as those discussed above.
“The preferred embodiment of the mask has elastomeric webbing 470 covering the front and perimeter of the openings for the panels that are located on the sides of its headband. The webbing adds structural integrity to the sleep apnea apparatus in a similar way that tendons and other structural members provide structural support for anatomical or architectural environments. The elastomeric webbing can be built in layers with the rest. You can make the webbing from any one of many thermoset materials, including both hard and soft thermosets.
FIG. “In FIG. 14A through 14H, the fifth embodiment of the sleep apnea 5000 is substantially the same as the fourth. However, an enclosure covering both the mouth and nose has been added. The internal chamber 5052 connects both the nasal tubes 5050 and the air ducts 5020 to this embodiment. This allows for a better distribution of pressure from the CPAP machine into the patient’s respiratory system. The mask and headband 5010 include panels 5012, 5012 which can be removed by friction fitting. This is similar to the fourth embodiment. Similar to the fourth embodiment, the fastener 5014 and the CPAP coupling5030 at the back are found on the headband. The mask’s inner face 5060 and the headband conform to the patient’s faces as determined from the scan data of their face.
“The mask may be designed to cover the nose or mouth and include a sneeze inhibitor mechanism. This prevents injury or discomfort if the mask is worn. The preferred embodiment of the mechanism includes a number of holes, or vias 5006, that expel air from the mask’s front. Other embodiments include a pressure-sensitive valve which releases air from the mask if the pressure exceeds a preset threshold. Elastomeric webbing 5070 may be used to cover the mask’s front.
“Illustrated at FIGS. “Illustrated in FIGS. There is a left and right portion of the mask that attaches to one side each. The mask also includes nasal tubes 6050 that are attached to the patient’s nose using pairs of magnets. Additionally, the mask includes at least one air duct 6020 that is connected to a CPAP machine to distribute air to the mask’s left and right sides. The left and right parts are shown separately, but they can be connected using one or more bridges (not illustrated) that run through the nose of the patient.
“According to the invention, the mask’s inner face is adjusted to the patient using scan data. This results in a mask that is custom-tailored for the patient. For example, the inner face of a mask could be made of flexible material such as silicone. The mask’s outer layer may be made of a plastic that can be built up layer by layer using one or more computer-aided production systems, such as the ones discussed herein.
“In each of six preferred embodiments, the sleep apnea devices connects to a CPAP machine via an elastic coupling. FIGS. 17A-17D show one version of an elastomeric CPAP-coupling. 17A-17D. The preferred embodiment of the coupling is made from three different elastomeric materials. The first elastomeric materials, such as silicone, are designed to flex under pressure. The first elastic material is used to construct the entire coupling between the CPAP output tube and the air ducts. The second elastomeric materials is a structural material which prevents the first material from ripping and tearing. The second elastomeric materials is used to create a shell-like webbing pattern that allows the coupling to flex and still hold pressure. The third elastomeric coupling is semi-rigid and can be used to contact the inner surface the CPAP output tube.
“Illustrated in FIGS. “Illustrated in FIGS. 16A-16G is a seventh embodiment for a sleep apnea system that includes a face mask 7000, nasal tubes 7050, and one or more valves 790 which regulate the flow of air from the nasal tubes. The left and right parts 7002 are fixed to each other by a bridge 7080. This embodiment does not include CPAP or CPAP-coupling. The values 7090 are designed to prevent airflow from the patient’s lungs, thereby maintaining positive pressure without external CPAP input. The preferred embodiment comprises one-way values which allow air to be inhaled while restricting air from leaving the nose during exhalation. This allows the patient to have a greater volume of air in their lungs than if they didn’t have the device. This volume helps keep the patient’s airways open, which in turn reduces the negative effects of sleep apnea.
“According to the invention, the inside face 7060 is designed using patient scan data so that the mask conforms to the patient?s face. You can also make the left and right parts of the mask from two or more materials, including silicone or another material that touches the patient’s skin and a second, more rigid material for the body and nasal tubes.
This embodiment of the one-way valve 7090 includes a retainer 7096 as well as an insert 7092 that is located in a cavity within a nasal tube. The retainer 7096 and inner wall of the nasal tube are where the insert 7092 are held. The insert 7092 can be moved vertically within the cavity. There are a number of apertures in the insert 7092, including a primary aperture 7093 as well as a plurality secondary apertures 7094. Air can flow into and out of the valve through the primary aperture 7093 with equal resistance in both directions. The secondary apertures 7094 provide more resistance to air flowing out of the nostril than it does to air flowing in. The apertures are designed so that the top of each aperture is relatively close to the primary aperture, while the bottom of each aperture is far away from the primary aperture. The insert is forced to the top by air pressure when the patient inhales. This allows air to flow through both the primary aperture and the secondary apertures. The patient exhales and the insert is forced to the bottom by air pressure. This forces air out of the cavity, where secondary apertures come into contact with the retainer. Air is still expelled through primary aperture. However, the primary aperture’s size and shape is designed to resist air escaping from the patient’s lungs.
Referring to FIG. Referring to FIG. 16G, one or several sleep apnea masks may include a plurality magnets 4052 that are designed to apply a biasing force in order to keep the mask in place. Magnets can be embedded in cavities within the nasal tubes 4050 or in cavities of the mask that are close together. The magnets are placed so that they flex the nasal tubes towards the mask, which creates a gentle pinching force around the nose. This pinching force is used to secure the mask to the patient’s head, either in place of or in lieu of a headband. Magnets can also be used to adjust the distance between the nose tubes and/or the face mask to improve the friction fit.
“In all seven of the above embodiments, the sleep-apnea device contacts the patient directly. One or more embodiments may use a pattern on the mask’s inner side and/or the headband that contacts the user to improve the seal. The pattern can be used to improve the seal between mask and face, or to increase friction between mask and face. For example, the pattern could include parallel lines, hashing or an array of dots.
“Illustrated at FIGS. 17A-17B show perspective views of a flexible CPAP coupling that is used in certain embodiments of the sleep apnea masque. The coupling 8000 includes a housing 8110 and an input port 8014 that can be connected to a CPAP machine output tub. The coupling can be attached to the CPAP machine by using a friction fit. The coupling’s outer wall 8010 and the inner wall of its input port 8014 squeeze the output of the CPAP machine into the recess 8012 to keep it in place during sleep. A plurality of output ports 8020 are also included in the coupling. These ports can be used to receive tubes, preferably polycarbonate tubing. To prevent accidental detachment of the polycarbonate tubing during mask use, the output ports have a fixed inner diameter and a wall thickness.
“Illustrated at FIG. 17D shows an exploded view showing the CPAP coupling, including the various components such as the external webbing 8030A and 8030B that are used to maintain its structural integrity. You can make the webbing from a thermoset material with a high tensile strength. The preferred embodiment of the CPAP coupling is made from highly elastic materials, primarily silicones. This allows for a pleasant user experience, whether the patient touches it, leans on it, or rolls against it.
“Some of these sleep apnea and/or face devices are made directly by one or more layerwise construction methods as described above. Other embodiments of the masks and sleep apnea devices are made using an investment molding technique as illustrated in FIG. 18. This embodiment uses one or more..STL? 1810 files are generated, which contain the set of.STL? files that define the dimensions and shapes of the molds and bucks used to cast mask components. The molds can then be 3D printed 1820 using any number of materials, while the bucks can be 3D printed 1830 using a second material capable of being dissolved with a first solvent. The mold, bucks and mask components are assembled 1840. The component’s casting material, which is preferably thermoset, is resistant to the first solvent. The solvent is then used to dissolve the 1860 bucks and to release the 1870 mask. Some embodiments of the mold are made from a soluble material which is different or the same as the material from the bucks. The component can be rinsed in order to get rid of any solvent traces before being used by the patient.
“Illustrated at FIG. 19 is a flowchart showing a second investment molding technique. The fabrication controller 136 generates 1910??? after the mask model has been created using the DPDS 130. Files defining the shape of one, or more, mask components. Negative spaces corresponding with air ducts. Support structures. If applicable. One or more bucks. A plurality of components make up the mask. They correspond to individual layers or pieces in the final mask. The?.STL? files are then created. The files for the negative spaces and mask components are then concurrently 3D printed 1920 with one or more soluble material. The negative spaces are created as a solid structure with a soluble material that can be later removed. The?.STL? The?.STL? files are printed 1930 simultaneously with the mask components, or separately. After the components, the negative mold, supports and bucks have been assembled, a first solvent 1940 is applied to remove one of several mask components. A new void is formed after the solvent has been removed. The new void is filled with a thermoset material. This thermoset material is allowed to cure. Decision block 1960 answers no if there are any soluble materials that may still be mask components. The next soluble material will be dissolved, and the next thermoset material will be injected. This process continues until all components of the mask are manufactured. The material that corresponds to the negative space can then be dissolved 1970 with an additional solvent. Thermoset structures must resist solvents after curing, as one skilled in the arts will know. This is to ensure that they are not accidentally removed. You can separate the mask components from any molds or support structures that were used. The resulting sleep apnea-mask may be made from multiple materials that have been completely bonded together. It may also contain one or more negative spaces.
“In the preferred embodiment, combinations soluble material/solvent include:
“Illustrated at FIGS. The preferred embodiment of 3D printing investment casting is illustrated in FIGS. 20A-20L. The final object is created by creating a series of temporary structures known as ‘patterns. These temporary structures are then removed sequentially and replaced with solvents or thermoset materials. FIG. FIG. 20A is the final object after printing and casting. FIG. FIG. 20B is a partial exploded image of the casting, where the three materials are separated to show the dimensionality and parts.
“According to the preferred embodiment, a multinozzle FDM machine is used to create three distinct patterns, by depositing three different materials. These three materials are referred to as?pattern B,? ?pattern B,? ?pattern B? FIGS. 20C-20E. Each pattern represents a part of the final object. Multiple nozzles can be used to deposit three different pattern materials, and then generate the object layer-wise. FIG. 20F shows the temporary object made from pattern materials. 20F. 20F.
Referring to FIG. “Referring to FIG. 20G, after the patterns have been fully printed, a first solvent, known as?solvent?, is used. Use this solvent to dissolve pattern A. FIG. Referring to FIG. 20H, after solvent has been removed from the part and it has been cleaned, a nozzle injects?material A? In the space left by pattern A, place?material A? Pattern B and C must resist solvent A, as anyone skilled in the art can see.
Referring to FIG. 20I is a second solvent, also known as “solvent B?” After material A has dried, 20I is used to dissolve pattern. Referring to FIG. Referring to FIG. 20J, after solvent B has been removed and the part is cleaned, anozzle injects?material B? In the space left by pattern B, place material A and C. Material A and C must be resistant against solvent B.”
Referring to FIG. 20K is a third solvent, also known as “solvent C?” After material B has dried, 20K is used to dissolve pattern. Refer to FIG. 20L: After solvent C has been removed from the part and cleaned up, a nozzle injects material C. The nozzle injects?material C into the space left by pattern C.
Materials A, B and C in the preferred embodiment are thermoset materials. Preferably, they include a mixture of soft and hard silicone thermoset materials. One skilled in the art will recognize that there are many other materials and 3D printing techniques available to make the investment casting technique described in this invention.
“Illustrated by FIGS. 21A through 21M are a series of diagrammatic illustrations that illustrates the 3D printing investment casting process used to create a CPAP coupling. FIG. FIG. 21B shows the final coupling in cross-section. 21A. 21A. 21C through 21E. 21C through 21E. 21F, and in cross section in FIG. 21G.”
Referring to FIG. 21H After the patterns have been printed fully, a?solvent? 21H, after the patterns are fully printed, a?solvent A? is used to dissolve pattern B. Referring to FIG. Referring to FIG. 21I, after solvent has been removed from the part and it has been cleaned, anozzle pours or injects?material A? In the space left by pattern A, place?material A? Pattern B and C, as one skilled in the art can see, are resistant to solvent A. One or more sprues or gates can be used to inject the material, and then evacuate air as necessary.
“Referring To FIG. 21J, ?solvent B? After material A has dried, 21J is used to dissolve pattern. Referring to FIG. Referring to FIG. 21K, after solvent B has been removed and the part is cleaned, anozzle injects?material B? In the space left by pattern B, place material A and C. Material A and C are both resistant to solvent B.”
“Referring To FIG. 21L, ?solvent C? After material B has dried, 21L (?solvent C?) is used to dissolve the pattern. Referring to FIG. Referring to FIG. 21M, after solvent C has been removed and the part is cleaned, anozzle injects?material C? 21M, after solvent C is removed and the part cleaned, a nozzle injects?material C? A face mask made using the above technique may be used to complete the coupling.
“Illustrated by FIGS. Diagrammatic illustration of investment casting techniques used to create a running shoe. FIG. 2 shows the finished running shoe in perspective. 22A, and FIG. 22B for an exploded view. 22B. FIG. 22C-FIG. 22C-FIG shows each of the five materials that are injected into a mold during assembly. FIG. 22G shows Material A being injected to form the sole of the shoe. 22C, Material B is injected to form sole of shoe in FIG. 22D, the material C was injected to make the shoe?upper’ FIG. 22E, the material D was injected to form FIG. 11F, material D injected to form FIG. 22G. 22G. Although it is not shown, every injection step begins with a step to dissolve a pattern. The final injection is completed. After that, the shoe is taken out of the mold. The investment casting technique can be used to create shoes with a unique structure and composition, as anyone skilled in the art will know.
The five materials are the shoe tread, sole and padding as well as the upper and lace grommets. The preferred embodiment uses thermoset materials for the first four injections, while nylon or another hard plastic is used for the final one.
“Systems and user interfaces according to the invention can be implemented using one or more non-transitory computer-readable media. Each medium may contain data or computer executable directions for manipulating data. Computer executable instructions can include data structures, objects and programs, routines or other program modules that can be accessed by a processor. These may include one associated either with a general-purpose or special-purpose processor, capable of performing many different functions, or one associated only with a specific-purpose computer that can perform a limited number. Computer executable instructions are program code that instruct the processor to perform a specific function or group functions. A particular sequence of executable instructions can be used as an example of corresponding actions that could be used to implement these steps. Computer-readable media can include random-access memory, (?RAM?) ), read-only memories (?ROM) ), read-only memory (??ROM? ), erasable, programmable read only memory (?EPROM) ), Electrically eraseable programmable read only memory (?EEPROM) ), compact disk read only memory (?CDROM? Compact disk read-only memory (?CDROM?) or any other component capable of storing data or executable instructions which can be accessed by a processor. Hard disk drives and magnetic disk drives are just a few examples of mass storage devices that include computer-readable media. Tape drives, optical drives, optical disk drive, solid state memory chips, and tape drives are all examples. As used herein, processor refers to any number of processing devices such as personal computing devices and servers, general purpose computers, specific purpose computers, application-specific circuits (ASIC) and digital/analog circuits containing discrete components.
“As a skilled artist in the art will know, the dimensions of a mask vary from person-to-person because the location and size of each patient’s features dictates the layout of those features.”
“Therefore, the invention was disclosed as an example, not a limitation. Refer to the following claims for further information about the scope of this invention.
Summary for “Customized medical equipment and apparel”
Sleep apnea is a condition that affects millions of people. It occurs when someone’s breathing pattern is disrupted while asleep. This condition can cause people to feel tired during the day and disrupt their sleep patterns at night. Air delivered via continuous positive airway pressure is a common treatment for sleep apnea. The machine delivers air using a mask that fits around the nose, nose, and mouth of the patient. The mask must be worn while the patient sleeps in order to be effective. In order to keep the pressure seal, the mask usually has rubber and plastic components. The current sleep apnea masks can be adjusted to fit a wide range of faces and sizes. Current sleep apnea masks are not designed to fit all patients. They may also be difficult to wear, have weak pressure seals, or may feel uncomfortable. To improve functionality and comfort, a custom-fitted sleep apnea mask is needed. This will increase the likelihood that the patient will be able to receive long-term successful treatment.
The preferred embodiment of the invention features a system for making a wearable article, such as a custom sleep apnea device that can be used with a CPAP machine. The preferred method involves scanning at least one portion of the user’s head; creating a surface model of his face; and identifying a set facial features using the surface model. A first point corresponds to the user?s nose and a second point corresponds to the user?s lips. The surface model generates a first contour based upon the first point. A second contour is generated based the second point. A third contour can be generated at an interposed position between the first contour and the second contours, offset from the user’s nostrils. Method 2 also includes creating an outer surface of a mask that contains the first, second and third contours. The inner surface of a mask is generated by the method between the second and first contours. Combining the inner and outer surfaces can create a 3D volume for a sleep apnea mask that can be printed with one of many 3D printers. Some embodiments combine the surface model for the user’s head with the surface model for a generic head to create a complete data set that can be used to generate a complete head mask.
“Another embodiment of the invention includes a sleep apnea machine that can be used with a CPAP device. The system includes a face mask and a headband connected to it. At least one air duct is also included to direct the air from the CPAP machine into the nasal tubes. The face mask should have an inner surface that is the same as the user’s facial shape, an upper surface that sits at a predetermined distance between the eyes and the nose, and an outer surface that extends a predetermined distance from this inner surface. To attach the CPAP machine to the pliable coupling, and to attach to at least one of the air ducts, a pliable coupling can be used. You can have an internal duct embedded within the headband or an external tube with flexible tubes attached to it.
“In some embodiments, an article custom made by the invention is provided. This involves providing user scan data that corresponds to a user’s face, providing generic data that corresponds to a portion of a head, and providing model data that corresponds to a sleep apnea or other article. The method also includes the creation of a model of the head and face by combining the user scan data with generic model data. The model data for the sleep apnea snoring mask is then fitted to the model of head and face based on user’s nose, mouth, or other anatomical characteristics. The model data of a mask is then matched to the model of the head and face to create a mask that fits the user’s head. This mask model can then be sent to a 3D printer to create the custom mask. The head and face are only two examples of the many body parts that user scan data can be combined with generic model data to create custom medical devices, apparel or other wearable articles.
“Illustrated at FIG. 1. is a functional block diagram for a network that implements one or more embodiments according to the present invention. A Dynamic 3D Printer Design System (DPDS 130) is part of the network that can be used to create medical devices and other custom-fitted parts. The preferred embodiment of the medical device is a sleeping apnea-mask, but the DPDS can also produce other medical and non-medical devices, such as eyewear, goggles and ski masks, scuba and footwear masks, and other apparel. To ensure comfort and superior fit, each mask is custom-made based on 3D scan data. This improves the effectiveness of the treatment and masks. These masks can be made using a variety of manufacturing techniques, such as one or more 3D printers 120-122, or other rapid prototyping or computer-aided manufacturing techniques.
“The data from the patient scans can be obtained using any one of many scanning systems that are available to those who are skilled in this art. Scanners such as the 3D Systems, Inc., Rock Hill, S.C., can be used to collect data points in a Euclidean three-dimensional space. A technician 110 may acquire the scan data from a patient 112 using a scanner 110, which is located in a clinic, pharmacy, hospital, or retail location. Another embodiment allows the user to acquire the scan data using a personal scanner 114. The preferred embodiment of scan data consists of 3D volume data that characterizes the shape, size and contours the head and/or faces of the patient in a three-dimensional coordinate system, such as a Cartesian or polar coordinate system. You can either store the scan data as point clouds or convert it to a surface model using one of the following formats: sub-divisional NURB data, non-uniform rational NURBS (aka sub-dNURBS), and/or a combination of parametric definitions. Common file types for representing scan data include mesh file types: .mud/.mb/.anim/.iff/.cpp/.fxa/.spt/.c4d/.aec/.exr/.mc4d/.3ds/.max/.act/.bip/.cel/.exr/.ztl/.stl/.ply/.amf; NURBS file types: .lxo/.blend/.blend2/.obj/.off/.mdd/.exr/.sdl/.wire/.3dm/.3dx/.ws/.3dc; and parametric file types: .dgn/.dgr/.rdl/.svf/.dwg/.dxf/.adsk/.ies/.rvt/.skp/.easm/.dwf/.dwfx/.iam/.idw/.ipt/.drw/.dxf/.jt/.lay/.prt/.sec/.slp/.stl/.drw/.dxf/.jt/.lay/.prt/.sec/.slp/.3dmap/.3dxml/.c18/.catpart/.catshape/.model/.sldprt/.sldasm/.tso/.xli/.scdoc/.ad_prt.”
“The DPDS 130 processes the patient’s scan data to create a medical device. Depending on the application the DPDS 130 can be located in the same place as the scanner or remote at a different facility via the Internet 102. The preferred embodiment of the DPDS 130 contains a product interface 132 and computational geometry processor 134. Fabric controller 136 is also included. Scan data database 138 is also included. The product interface 132 can be used to select and determine one of several medical devices or components that will be generated using the scan data. The computational geometry processor (CGP134) is used to clean the scan data from artifacts and to fit a generic model to the scan data. It then generates a custom-fit mask for each patient. The fabrication geometry processor FGP 136 converts the data representing the customized mask into one or several?.STL? Files and/or other manufacturing instructions that are specific to the 3D printers 120-122 chosen/used to make the custom mask. The DPDS 130 may also include a biodata interface 140 that allows patients to access their personal physiological or biological data 140 in order to modify the size, shape or functionality of the mask.
“Illustrated at FIG. 2. This is a flowchart showing the process of creating a custom-fit sleeping apnea or medical device. After taking a 3D scan 210 of the patient’s head and face, 212 is chosen from a variety of mask types. A digital model of the mask is created from the selected mask type. The patient’s scan data is used to create a digital model of the mask. This will result in a mask that provides maximum comfort and a reliable seal. The mask model is modified to create 216 data files and computer instructions that are used to build or modify 218 the mask custom-fit for the patient.
“Illustrated at FIG. 3. The product interface according to the preferred embodiment shown in FIG. 1. The mask selection processor 310 is part of the product interface 132. It allows a technician to select a sleep apnea syringe from a variety of options. These include (1) a nasal mask that can attach to and receive continuous positive airway pressure (CPAP), (2) a mask for the mouth and nose with a CPAP attachment and (3) a mask equipped with nasal tubes with CPAP attachment and (3) a mask with tubes and valves. A CPAP attachment masks generally have a coupling and one to several integrated air ducts that connect the sleep apnea device with the pressurized CPAP output. These one or more air conduits may be embedded in the mask, or set of elastic tubes that are routed outside to a mask headband.
The tube selection processor 320 allows you to choose between embedded or external ducting options, if they are available. The technician can choose from a variety of attachment mechanisms to connect directly to the CPAP output tube to the mask using the pneumatic coupling selection 330. There are many attachment mechanisms that can be used to connect the mask and CPAP output tube. They all have different couplings, which correspond to different sizes, shapes, or locations on the patient?s head. The patient fitting processor (340) allows the technician to adjust and fit the mask model to the patient. The preferred embodiment does not require any manual adjustments. However, the interface 132 allows the technician to adjust the size and position of the mask and the headband to suit the patient’s sleeping habits. To avoid interfering with patient’s eyes and ears, the location of the headband can also be changed. The module for attachment selection 350 allows the technician to modify the mask model to include alternative mechanisms to attach the mask to the patient. For example, one or more magnets, or shape-changing alloys, may be placed into the mask to create a force that biases it against the patient’s face. The customization processor 360 allows the modification of the mask model to include stylistic and aesthetic design features such as colors, graphics and embossing.
“In certain embodiments, the product interface also includes a processor (370) for customizing masks based on personal diagnostic measurements (PDM). PDMs can include information about the airflow capacity and anatomy of the patient’s esophagus (determined using magnetic resonance imaging (MRI), scan data, or x-ray scans data, e.g. This data can be used to determine the size and shape optimal for the air ducts of the sleep apnea mask. The air passages of the sleep apnea Mask may be expanded to allow maximum air flow to compensate for difficulty breathing, such as a blocked nose.
“Illustrated at FIG. “Illustrated in FIG. 1. CGP 134 can receive both the mask model and patient scan data from the product interface 132. Before merging the mask model with the scan data, artifacts must be identified and removed using an artifact elimination module 410. Patients’ hair can cause significant artifacts by not scanning well. This results in gaps in the data set and incorrect scan points. CGP 134 also includes a manifold integration processor 420. This is used to convert patient scan data to a surface manifold, if it is not already. It then removes any holes or apertures from the manifold that could prevent or interfere in the production of the mask model, or 3D printing operation.
“Some embodiments of the patient scan data consist of a manifold that represents the face. This generally covers the area from the forehead down to the chin, and the region from ear to toe. The embodiment may require scan data that only represents the face to create a sleep apnea or compliance mask. The CGP 134 has a processor 430 that can combine the face data with a generic head model to create a complete model of the patient’s head. FIGS. 5A-5C show the process of merging and/or otherwise combining head data and face data. 5A-5C. The preferred embodiment shows the face data as a 2D surface in FIG. 5A and FIG. 5B, respectively. 5B. 5B. Transitions between the head model and face data should be smooth, proportionate, and consistent at the borders. The gaps between the head and face manifolds can be filled with any of the many surfacing techniques, such as lofting. As shown in FIG. 5, the result is a single surface, including head and face, that represents each patient’s head. 5C. 5C.
“In some instances, the head data that is to be combined with the face data are selected from a variety of generic head models. To provide a variety of models to represent different body shapes and proportions, a database may contain a number of generic head models. Patients may choose their own head models based on their ancestry, gender and age. The face data can be merged with the best model by testing several candidates. The preferred embodiment of the optimal head model is the one that produces the least geometric error. This means that it is the model that gives maximum tangency between the face data and the head data. Maximal tangency refers to the minimum rate of curvature change at the boundary of the head and face data. This is averaged across the entire boundary.
“The feature identification processor 440 then locates one or several anatomical features (e.g. eyes, nose, mouth and ears) in the model of the patient’s head. These features are used as control points to automatically align, register, fit, shape, and/or design the customized mask model. The control point fitting processor (450) is used to adjust the size, orientation, and/or position of the mask to fit around the nose and mouth. It also allows the operator to adjust straps or other external air ducts, if any, to adjust the position above and below the ears.
“In one preferred embodiment, a model of the mask has been constructed using a technique called “Boolean Volume Subtraction.” FIGS. 6A-6C. The volume subtraction technique involves superimposing a 3D mask model and the 3D volume of a patient’s head and subtracting a portion from the mask model. Particularly, the 3D mask model (510) in FIG. 6A extends or protrudes into the interior space of model 520 of FIG. 6B to ensure that both models overlap in the area of the straps and face. After aligning the mask and patient scan data, a compliance determination process 460 removes the part of the mask model that interferes with the interior of the head model. The mask 530 remains is a custom mask with an inner surface that matches the patient’s face. Each patient is different, so each mask model is also unique. In FIGS, we also discuss other techniques to create a custom-fit mask. 8A-8F and 9A-9D.”
“Illustrated at FIG. FIG. 7 shows the fabrication geometry processor (FGP136) in accordance to the preferred embodiment of DPDS 130. 1. Using the FGP 136, a technician chooses a manufacturing method or system for one or more components. Direct 3D printing one or more components of the mask and/or 3D printing a mold from which some or all of the mask components can be cast may be used. The user has the option to build the mold or portion of the mask using stereolithography (SLA), 720, fused-deposition modeling (FDM), 730, fused filament fabricat (FFF), starch based printing system 740 and selective laser sintering 750. Printing 760 and/ENVISIONTEC? 3D printing. After selecting the manufacturing methods, the FGP136 converts the customized mask model into one or several print files, manufacturing instructions and/or assembly directions specific to the chosen 3D printer. It generally involves the creation of one or more?.STL files. Files from the parametric solids (mesh) or non-uniform rational b-spines data models (NURBS).
“In addition, the?Boolean Volume Subtraction? The custom-fit mask can be made using any of the techniques mentioned above. technique, or (b) a parametric fitting? FIGS. 8A-8F and (c) a “press fit?” FIGS. 9A-9D. 9A-9D. The?NURBS subtraction? technique converts the mesh model of the patient (including the combination data of head and face data) to a nonuniform rational basis spiral (NURBS). The mask model, also known as NURBS, can be superimposed on top of the NURBS patient model. As mentioned above, the mask’s size, position, or proportions can be altered to accommodate anatomical features detected by the feature identification processor (440). Once the head and mask models have been aligned, the compliant version is generated from the intersection of NURBS mask and patient. The NURBS portion of a patient model that is bounded by the mask model are identified. Also, the NURBS portion of a mask model that lies outside of the patient model’s boundary is identified. The NURBS section of the patient-model is the area between the upper and lower edges of masks where patient and patient models intersect. The NURBS section of the mask is the portion of the model that extends outwards from the patient model. The NURBS surface of each portion is combined to form a NURBS volume that represents a compliant mask. The fabrication geometry processor then processes the NURBS volume in the following manner.
“In the?parametric fit? FIGS. FIGS. 8A-8F illustrate the custom-designed mask and its interior volume. This technique is different from other techniques that only the mask’s inner face can be customized for each patient. The present embodiment has three parts: (a) the inner face of the mask; (b) its interior structure and (c) its outer surface. These are custom-designed for each patient to optimize fit and airflow, minimize material consumption, and/or reduce the size of the mask. The parametric fitting process involves measuring or locating points on the user’s face in three dimensions. The mask shape is then determined relative to these points. Parametric fitting ensures that each patient’s mask fits regardless of their height, width, or overall size. This is in spite of differences in age, gender, and ethnicity.
The preferred embodiment of the parametric fitting process for designing the mask starts with the acquisition and recognition of features as well as the 3D head model. After determining the location of the eyes and nose, the mask design system will locate the following anatomical points from the scan data of the patient: (a) The tip of your nose 810; (b) The bridge of your nose 812 between the eyes 814; (c) The uppermost point of your lips 816 closest the nose; (d) The underside of nose 818 closest the upper lip; (e) The width of your face 822, 824 and (f) Center points of the nostrils 820. These points will vary from one patient to the next. The mask design system uses the scan data to determine the best location for the (a) upper edges of masks, (b) shape of upper edges of masks, (c) bottom edges of masks, (d) shape of bottom edge masks, and (e) height of mask off the face across the whole face.
“First, the mask fitting device 450 locates the point approximately half-way between the tip and bridge of your nose. This point is referred to as the mid-nose location 830. This point, in the preferred embodiment, is 60% of distance between tip and bridge measured from the tip. The upper edge of mask is then anchored at the mid-nose point. The mask’s desired shape is then created by fitting a predetermined curve 832 between the mid nose point and the left 822 side of the face. The projections of the curves that span the left and right sides are made in one plane. A contour in 3D space represents the intersection of the projections of the curves with the scan data. The mask’s upper edge is located by the first contour 840.
Third, the mask system finds a point approximately half-way between the nose and lips. This point is referred to as the philtral Dimple Point or simply dimple point 834. This point corresponds to 40% of the distance from the upper tip 816 on the upper lips to the lower end of the nose, measured from the upper mouth. The lower edge of the mask is then anchored by the dimple point 834. A point below the lips can be used to cover both the nose or mouth instead of the 834 dimple point. A fourth predetermined curve 836 that defines the desired mask shape is fitted between the dimple nose tip and the left side 824 and the right side 824. This measurement determines the facial width. The projection of the curves that span the left and right sides are done in one plane. A contour in 3D space represents the intersection of the projections of the curves with the scan data. This second contour 842 marks the lower edge of mask. FIG. 841 illustrates the portion of 3D patient data that lies between the first contour (840) and the second contour (842). 8C.”
“Fifth, a mask offset delineating the forward-most edge is determined using a?tween contour. FIG. 844 8D. The tween contour can be calculated by (1) creating a 2D curve by adding the vertical heights of the upper contours 840.842 to the patient’s head data; (2) projecting the 2D curve onto the patient’s head data to generate a 3D curve; (3) creating an offset curve by taking the 3D curve coinciding in with the scan data, and then adding a fixed offset distance in front of the face; (4) generating final tween contour 844 through smoothing or by filtering the edges. You can adjust the offset distance to match the height of your mask, to a particular wall thickness, or to a distance beyond the tip.
“The foundations of a number of cross section curves are laid on top of the upper and lower contours 842, 840, and 842. The final tween contour 844 is used to create the outer surface of a mask. FIG. 8E shows the cross section curves. 8E shows the general cross section at different points along the length of the mask. A cross section curve, which is a line that intersects the upper, lower, and final tween contours 842 and 840 at each point along the length, can be found at every point along the width. The plane projects roughly at a right angle to the intersection of the upper contour. This creates the outer surface 860 of a mask by including each cross section curve.
“The mask’s outer surface 860 is not the only thing that needs to be determined. The mask’s inner surface can also be determined by the contours of its upper and lower surfaces. The upper and lower contours can be used to segment the relevant sections of patient’s head scan data or face scan data 860 shown in FIG. 8C. 8C.
“In some embodiments, the initial form defined by the outer and inner surfaces acts as a template for other mask features such as nasal tubes, hose connections and clips. The preferred embodiment of nasal tubes is also designed according to anatomical points, such as (a) the centers points of the nostrils, (b) the tip of the nose, and (c), the bridge of the mouth 812. The nasal tubes are concentric around the nostrils’ center points. In particular, the orientation of nasal tubes is parallel with the line connecting the bridge of 812 and tip of 810.
“Another embodiment of the mask uses the “press fit” design technique. FIGS. 9A-9D. The mask is created by adapting or morphing a generic mask onto patient scan data. The mask is created by a generic 3D model. It is then scaled, rotated and vertically aligned at an area in front of the scan data. This position uses the anatomical features as well as various points, including the dimple point 834 and mid-nose point 830. The mask model is placed next to the scan data. This is done by aligning the upper and lower edges of each mask vertically with the mid-nose and dimple points. In FIG. 9B, the mask model 910 is located adjacent to the scan data 930. 9B, and in cross-section in FIG. 9C. Second, the mask model 901, which is located in front of the scan 930, is mathematically pressed onto the face or stretched so that the mask’s inner surface 920 takes on the shape of scan data 930. FIG. 9C shows the generic mask before pressing. 9C, and the custom mask 912 that is created after pressing are shown in FIG. 9D. 9D. For manufacturing, the final mask model can be sent to the printer.
“Illustrated at FIGS. FIGS. 10A-10N show a first embodiment for a sleep apnea machine. It includes a face mask 1000 that is aligned with the patient’s nose and a headband 1010. The mask is secured to the face using air ducts 1020. This allows for the CPAP machine pressurized air to be channeled to the mask. A pair of nasal tubes may be included in the face mask to channel air directly to the nose. There may also be one or more connectors or manifolds 1002 to connect the air ducts and nasal tubes. In the preferred embodiment, the air ducts 1020 are made of vinyl or polycarbonate tubes and run along the back of your head to the face mask. The polycarbonate tubes can diverge from the head, where they connect to a single coupling that detachably attaches to the CPAP machine’s output tube. This multi-tube coupling 1030 is sometimes referred to as a “spider coupling”. FIGS. 17A-17D. 17A-17D. The headband 1010 is usually made from flexible material such as silicone. The headband can be attached to the patient’s back using a fastener such as a clip, button or strap.
“The inner face 1060 and the headband of the mask are designed to fit the patient’s face. The size and spacing of each pair of nasal tubes are tailored to the needs of the patient who will be using the mask. The mask and headband can be customized for each patient based on scan data. There are no two masks that can be identical.
The mask should be sized to fit the patient’s face. It should have a flexible and a rigid section. For example, the flexible portion that comes in contact with patient’s faces may be made of bio-safe rubber or silicone. The rigid portion of the mask could be made of a plastic that can be built layer by layer using one or more rapid prototyping or computer-aided manufacturing methods, such as those discussed herein. FIGS. FIGS. 10J and 10K show the facial portion of the mask, which includes a base plate as well as left and right manifolds 1002, shown in FIGS. 10L to 10N A manifold is an enclosed cavity that contains (1) multiple input holes 1004 to receive the end of each polycarbonate tub 1020 and (2) an outhole 1006 to channel air into one or more of the nasal tubes. Each manifold is designed to fit into the base plate and friction fit onto it.
“Like the mask the inner face 1060 may be made of silicone or another elastomeric material. It is flexible and comfortable for the patient’s skin.
Referring to FIG. 10D. The mask contains nasal tubes 1050, which are designed to reach a small distance into the nose of the patient. FIG. 10F shows the nasal tubes in cross section. 10F, and FIG. 10G. The preferred embodiment of the nasal tubes is made from an elastomeric material. The nasal tubes can expand slightly in the nose when positive air pressure is applied to them. This allows the tubes to better fit the patient’s nose while maintaining the pressure induced from the CPAP machine.
Referring to FIG. “Referring to FIG. Magnets can be embedded outside of the nose or inside the nasal tube to create a gentle pinching force to hold the mask on the patient’s head. The preferred embodiment includes the cavities that can receive magnets or ferrous material in the model of mask, as well as the magnets/ferrous materials that are inserted after production.
“In FIGS. FIGS. 11A to 11F show a second embodiment of the sleep apnea mask. It uses the polycarbonate tube 2020 to attach the mask 2000 to the patient’s forehead without any underlying strap or band. The face mask has a base plate 2060, a conformal inner layer, nasal tubes 1050 and manifolds 2002 that are coupled to the polycarbonate tube. The base plate 2060’s inner surface has a recess that conforms to the patient?s nose. The tubes that make up an air duct are attached to multiple retainers 2040. These retainers have channels into which the tubes can seat. This is different from the previous embodiment. FIG. FIG. 11F receives a number of tubes from the CPAP fitting 2030 and divides them using the guide holes 2046. The tubes are held in place by a second and third set 2040 of retainers 2040. They travel from the patient’s cheek to the face mask using channels 2042. Additional channels 2022 are included in the face mask 2000, into which the tubes can be seated. This is a fourth set. The length of the tubes connecting the face mask to the first retainer determines the location of the mask. The patient can adjust the position of the mask by simply retracting the tubes from the first retentioner or inserting the tubes into the second retainer.
“In FIGS. FIGS. 12A-12B show a third embodiment of the sleep apnea mask 3000. It is substantially the same as the mask 1000 in the first embodiment, but with an enclosure 3004 covering a portion the nose and mouth. The manifold (not illustrated) is used to blow air into the nasal tubes 1050 and the enclosed 3004 covering the mouth. This helps maintain pressure in the patient?s respiratory system. Vent holes 3006 allow air to escape the enclosure if the patient sneezes. The third version of the mask, like the first, includes a headband to secure the mask to the face as well as external air ducts to channel pressurized air from CPAP machine to mask.
“Illustrated at FIGS. FIGS. 13A to 13J show a fourth embodiment for a sleep apnea machine. It includes a face mask 4000 that coincides with the patient’s nose, a 4010 headband, and one or several air ducts 4020 which channel pressurized air from CPAP machine to mask. The coupling 4030 is a tube-shaped device that conducts air from CPAP machine to headband air ducts. FIGS. 17A-17D. 17A-17D. The internal air ducts 4020 are embedded within the headband4010. They run from the back of your head to one or both faces, then on to the nasal tubes 4050 inside the mask. FIG. 13H shows a cross-section of the air ducts. FIG. 13H shows a cross-section of the air ducts, while FIG. 13I shows a cross-section of the cavity and face mask. 13I. 13I. There are a number of panels 4002 that can be snapped in and frictionally fitted to the enclosure. The right and left portions of the 4010 headband include caps or panels 4012 which snap in and frictionally attach to the headband. These panels, or caps 4002 and 4012 allow access to the cavity and air ducts for the purpose of removing any support material that may have been deposited during manufacturing.
“The nasal tubes 4050 could contain a cavity in which a magnet 4052 can be inserted. In close proximity to the nasal tubes 40550, a cavity and a magnet 4052 have been created in the enclosure.
The headband 4010 is usually made from flexible material, where it touches the skin of the patient. The headband can be attached to the patient’s back using a fastener 4014 or clip, strap, magnet, or strap.
“According to the invention, the inner faces 4060 and inner faces of the headband of the face mask are designed to fit the patient’s face. The mask and headband can be adjusted to suit the patient. The mask and headband for sleep apnea devices are customized to the patient’s needs, as they are based on scan data. For example, the inner face of the headband and mask may be made of flexible elastomeric materials such as silicone. The outer part of the headband and mask may be made of plastic that can be built layer by layer using one or more computer-aided production systems, such as those discussed above.
“The preferred embodiment of the mask has elastomeric webbing 470 covering the front and perimeter of the openings for the panels that are located on the sides of its headband. The webbing adds structural integrity to the sleep apnea apparatus in a similar way that tendons and other structural members provide structural support for anatomical or architectural environments. The elastomeric webbing can be built in layers with the rest. You can make the webbing from any one of many thermoset materials, including both hard and soft thermosets.
FIG. “In FIG. 14A through 14H, the fifth embodiment of the sleep apnea 5000 is substantially the same as the fourth. However, an enclosure covering both the mouth and nose has been added. The internal chamber 5052 connects both the nasal tubes 5050 and the air ducts 5020 to this embodiment. This allows for a better distribution of pressure from the CPAP machine into the patient’s respiratory system. The mask and headband 5010 include panels 5012, 5012 which can be removed by friction fitting. This is similar to the fourth embodiment. Similar to the fourth embodiment, the fastener 5014 and the CPAP coupling5030 at the back are found on the headband. The mask’s inner face 5060 and the headband conform to the patient’s faces as determined from the scan data of their face.
“The mask may be designed to cover the nose or mouth and include a sneeze inhibitor mechanism. This prevents injury or discomfort if the mask is worn. The preferred embodiment of the mechanism includes a number of holes, or vias 5006, that expel air from the mask’s front. Other embodiments include a pressure-sensitive valve which releases air from the mask if the pressure exceeds a preset threshold. Elastomeric webbing 5070 may be used to cover the mask’s front.
“Illustrated at FIGS. “Illustrated in FIGS. There is a left and right portion of the mask that attaches to one side each. The mask also includes nasal tubes 6050 that are attached to the patient’s nose using pairs of magnets. Additionally, the mask includes at least one air duct 6020 that is connected to a CPAP machine to distribute air to the mask’s left and right sides. The left and right parts are shown separately, but they can be connected using one or more bridges (not illustrated) that run through the nose of the patient.
“According to the invention, the mask’s inner face is adjusted to the patient using scan data. This results in a mask that is custom-tailored for the patient. For example, the inner face of a mask could be made of flexible material such as silicone. The mask’s outer layer may be made of a plastic that can be built up layer by layer using one or more computer-aided production systems, such as the ones discussed herein.
“In each of six preferred embodiments, the sleep apnea devices connects to a CPAP machine via an elastic coupling. FIGS. 17A-17D show one version of an elastomeric CPAP-coupling. 17A-17D. The preferred embodiment of the coupling is made from three different elastomeric materials. The first elastomeric materials, such as silicone, are designed to flex under pressure. The first elastic material is used to construct the entire coupling between the CPAP output tube and the air ducts. The second elastomeric materials is a structural material which prevents the first material from ripping and tearing. The second elastomeric materials is used to create a shell-like webbing pattern that allows the coupling to flex and still hold pressure. The third elastomeric coupling is semi-rigid and can be used to contact the inner surface the CPAP output tube.
“Illustrated in FIGS. “Illustrated in FIGS. 16A-16G is a seventh embodiment for a sleep apnea system that includes a face mask 7000, nasal tubes 7050, and one or more valves 790 which regulate the flow of air from the nasal tubes. The left and right parts 7002 are fixed to each other by a bridge 7080. This embodiment does not include CPAP or CPAP-coupling. The values 7090 are designed to prevent airflow from the patient’s lungs, thereby maintaining positive pressure without external CPAP input. The preferred embodiment comprises one-way values which allow air to be inhaled while restricting air from leaving the nose during exhalation. This allows the patient to have a greater volume of air in their lungs than if they didn’t have the device. This volume helps keep the patient’s airways open, which in turn reduces the negative effects of sleep apnea.
“According to the invention, the inside face 7060 is designed using patient scan data so that the mask conforms to the patient?s face. You can also make the left and right parts of the mask from two or more materials, including silicone or another material that touches the patient’s skin and a second, more rigid material for the body and nasal tubes.
This embodiment of the one-way valve 7090 includes a retainer 7096 as well as an insert 7092 that is located in a cavity within a nasal tube. The retainer 7096 and inner wall of the nasal tube are where the insert 7092 are held. The insert 7092 can be moved vertically within the cavity. There are a number of apertures in the insert 7092, including a primary aperture 7093 as well as a plurality secondary apertures 7094. Air can flow into and out of the valve through the primary aperture 7093 with equal resistance in both directions. The secondary apertures 7094 provide more resistance to air flowing out of the nostril than it does to air flowing in. The apertures are designed so that the top of each aperture is relatively close to the primary aperture, while the bottom of each aperture is far away from the primary aperture. The insert is forced to the top by air pressure when the patient inhales. This allows air to flow through both the primary aperture and the secondary apertures. The patient exhales and the insert is forced to the bottom by air pressure. This forces air out of the cavity, where secondary apertures come into contact with the retainer. Air is still expelled through primary aperture. However, the primary aperture’s size and shape is designed to resist air escaping from the patient’s lungs.
Referring to FIG. Referring to FIG. 16G, one or several sleep apnea masks may include a plurality magnets 4052 that are designed to apply a biasing force in order to keep the mask in place. Magnets can be embedded in cavities within the nasal tubes 4050 or in cavities of the mask that are close together. The magnets are placed so that they flex the nasal tubes towards the mask, which creates a gentle pinching force around the nose. This pinching force is used to secure the mask to the patient’s head, either in place of or in lieu of a headband. Magnets can also be used to adjust the distance between the nose tubes and/or the face mask to improve the friction fit.
“In all seven of the above embodiments, the sleep-apnea device contacts the patient directly. One or more embodiments may use a pattern on the mask’s inner side and/or the headband that contacts the user to improve the seal. The pattern can be used to improve the seal between mask and face, or to increase friction between mask and face. For example, the pattern could include parallel lines, hashing or an array of dots.
“Illustrated at FIGS. 17A-17B show perspective views of a flexible CPAP coupling that is used in certain embodiments of the sleep apnea masque. The coupling 8000 includes a housing 8110 and an input port 8014 that can be connected to a CPAP machine output tub. The coupling can be attached to the CPAP machine by using a friction fit. The coupling’s outer wall 8010 and the inner wall of its input port 8014 squeeze the output of the CPAP machine into the recess 8012 to keep it in place during sleep. A plurality of output ports 8020 are also included in the coupling. These ports can be used to receive tubes, preferably polycarbonate tubing. To prevent accidental detachment of the polycarbonate tubing during mask use, the output ports have a fixed inner diameter and a wall thickness.
“Illustrated at FIG. 17D shows an exploded view showing the CPAP coupling, including the various components such as the external webbing 8030A and 8030B that are used to maintain its structural integrity. You can make the webbing from a thermoset material with a high tensile strength. The preferred embodiment of the CPAP coupling is made from highly elastic materials, primarily silicones. This allows for a pleasant user experience, whether the patient touches it, leans on it, or rolls against it.
“Some of these sleep apnea and/or face devices are made directly by one or more layerwise construction methods as described above. Other embodiments of the masks and sleep apnea devices are made using an investment molding technique as illustrated in FIG. 18. This embodiment uses one or more..STL? 1810 files are generated, which contain the set of.STL? files that define the dimensions and shapes of the molds and bucks used to cast mask components. The molds can then be 3D printed 1820 using any number of materials, while the bucks can be 3D printed 1830 using a second material capable of being dissolved with a first solvent. The mold, bucks and mask components are assembled 1840. The component’s casting material, which is preferably thermoset, is resistant to the first solvent. The solvent is then used to dissolve the 1860 bucks and to release the 1870 mask. Some embodiments of the mold are made from a soluble material which is different or the same as the material from the bucks. The component can be rinsed in order to get rid of any solvent traces before being used by the patient.
“Illustrated at FIG. 19 is a flowchart showing a second investment molding technique. The fabrication controller 136 generates 1910??? after the mask model has been created using the DPDS 130. Files defining the shape of one, or more, mask components. Negative spaces corresponding with air ducts. Support structures. If applicable. One or more bucks. A plurality of components make up the mask. They correspond to individual layers or pieces in the final mask. The?.STL? files are then created. The files for the negative spaces and mask components are then concurrently 3D printed 1920 with one or more soluble material. The negative spaces are created as a solid structure with a soluble material that can be later removed. The?.STL? The?.STL? files are printed 1930 simultaneously with the mask components, or separately. After the components, the negative mold, supports and bucks have been assembled, a first solvent 1940 is applied to remove one of several mask components. A new void is formed after the solvent has been removed. The new void is filled with a thermoset material. This thermoset material is allowed to cure. Decision block 1960 answers no if there are any soluble materials that may still be mask components. The next soluble material will be dissolved, and the next thermoset material will be injected. This process continues until all components of the mask are manufactured. The material that corresponds to the negative space can then be dissolved 1970 with an additional solvent. Thermoset structures must resist solvents after curing, as one skilled in the arts will know. This is to ensure that they are not accidentally removed. You can separate the mask components from any molds or support structures that were used. The resulting sleep apnea-mask may be made from multiple materials that have been completely bonded together. It may also contain one or more negative spaces.
“In the preferred embodiment, combinations soluble material/solvent include:
“Illustrated at FIGS. The preferred embodiment of 3D printing investment casting is illustrated in FIGS. 20A-20L. The final object is created by creating a series of temporary structures known as ‘patterns. These temporary structures are then removed sequentially and replaced with solvents or thermoset materials. FIG. FIG. 20A is the final object after printing and casting. FIG. FIG. 20B is a partial exploded image of the casting, where the three materials are separated to show the dimensionality and parts.
“According to the preferred embodiment, a multinozzle FDM machine is used to create three distinct patterns, by depositing three different materials. These three materials are referred to as?pattern B,? ?pattern B,? ?pattern B? FIGS. 20C-20E. Each pattern represents a part of the final object. Multiple nozzles can be used to deposit three different pattern materials, and then generate the object layer-wise. FIG. 20F shows the temporary object made from pattern materials. 20F. 20F.
Referring to FIG. “Referring to FIG. 20G, after the patterns have been fully printed, a first solvent, known as?solvent?, is used. Use this solvent to dissolve pattern A. FIG. Referring to FIG. 20H, after solvent has been removed from the part and it has been cleaned, a nozzle injects?material A? In the space left by pattern A, place?material A? Pattern B and C must resist solvent A, as anyone skilled in the art can see.
Referring to FIG. 20I is a second solvent, also known as “solvent B?” After material A has dried, 20I is used to dissolve pattern. Referring to FIG. Referring to FIG. 20J, after solvent B has been removed and the part is cleaned, anozzle injects?material B? In the space left by pattern B, place material A and C. Material A and C must be resistant against solvent B.”
Referring to FIG. 20K is a third solvent, also known as “solvent C?” After material B has dried, 20K is used to dissolve pattern. Refer to FIG. 20L: After solvent C has been removed from the part and cleaned up, a nozzle injects material C. The nozzle injects?material C into the space left by pattern C.
Materials A, B and C in the preferred embodiment are thermoset materials. Preferably, they include a mixture of soft and hard silicone thermoset materials. One skilled in the art will recognize that there are many other materials and 3D printing techniques available to make the investment casting technique described in this invention.
“Illustrated by FIGS. 21A through 21M are a series of diagrammatic illustrations that illustrates the 3D printing investment casting process used to create a CPAP coupling. FIG. FIG. 21B shows the final coupling in cross-section. 21A. 21A. 21C through 21E. 21C through 21E. 21F, and in cross section in FIG. 21G.”
Referring to FIG. 21H After the patterns have been printed fully, a?solvent? 21H, after the patterns are fully printed, a?solvent A? is used to dissolve pattern B. Referring to FIG. Referring to FIG. 21I, after solvent has been removed from the part and it has been cleaned, anozzle pours or injects?material A? In the space left by pattern A, place?material A? Pattern B and C, as one skilled in the art can see, are resistant to solvent A. One or more sprues or gates can be used to inject the material, and then evacuate air as necessary.
“Referring To FIG. 21J, ?solvent B? After material A has dried, 21J is used to dissolve pattern. Referring to FIG. Referring to FIG. 21K, after solvent B has been removed and the part is cleaned, anozzle injects?material B? In the space left by pattern B, place material A and C. Material A and C are both resistant to solvent B.”
“Referring To FIG. 21L, ?solvent C? After material B has dried, 21L (?solvent C?) is used to dissolve the pattern. Referring to FIG. Referring to FIG. 21M, after solvent C has been removed and the part is cleaned, anozzle injects?material C? 21M, after solvent C is removed and the part cleaned, a nozzle injects?material C? A face mask made using the above technique may be used to complete the coupling.
“Illustrated by FIGS. Diagrammatic illustration of investment casting techniques used to create a running shoe. FIG. 2 shows the finished running shoe in perspective. 22A, and FIG. 22B for an exploded view. 22B. FIG. 22C-FIG. 22C-FIG shows each of the five materials that are injected into a mold during assembly. FIG. 22G shows Material A being injected to form the sole of the shoe. 22C, Material B is injected to form sole of shoe in FIG. 22D, the material C was injected to make the shoe?upper’ FIG. 22E, the material D was injected to form FIG. 11F, material D injected to form FIG. 22G. 22G. Although it is not shown, every injection step begins with a step to dissolve a pattern. The final injection is completed. After that, the shoe is taken out of the mold. The investment casting technique can be used to create shoes with a unique structure and composition, as anyone skilled in the art will know.
The five materials are the shoe tread, sole and padding as well as the upper and lace grommets. The preferred embodiment uses thermoset materials for the first four injections, while nylon or another hard plastic is used for the final one.
“Systems and user interfaces according to the invention can be implemented using one or more non-transitory computer-readable media. Each medium may contain data or computer executable directions for manipulating data. Computer executable instructions can include data structures, objects and programs, routines or other program modules that can be accessed by a processor. These may include one associated either with a general-purpose or special-purpose processor, capable of performing many different functions, or one associated only with a specific-purpose computer that can perform a limited number. Computer executable instructions are program code that instruct the processor to perform a specific function or group functions. A particular sequence of executable instructions can be used as an example of corresponding actions that could be used to implement these steps. Computer-readable media can include random-access memory, (?RAM?) ), read-only memories (?ROM) ), read-only memory (??ROM? ), erasable, programmable read only memory (?EPROM) ), Electrically eraseable programmable read only memory (?EEPROM) ), compact disk read only memory (?CDROM? Compact disk read-only memory (?CDROM?) or any other component capable of storing data or executable instructions which can be accessed by a processor. Hard disk drives and magnetic disk drives are just a few examples of mass storage devices that include computer-readable media. Tape drives, optical drives, optical disk drive, solid state memory chips, and tape drives are all examples. As used herein, processor refers to any number of processing devices such as personal computing devices and servers, general purpose computers, specific purpose computers, application-specific circuits (ASIC) and digital/analog circuits containing discrete components.
“As a skilled artist in the art will know, the dimensions of a mask vary from person-to-person because the location and size of each patient’s features dictates the layout of those features.”
“Therefore, the invention was disclosed as an example, not a limitation. Refer to the following claims for further information about the scope of this invention.
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