Customized Medical Devices and Apparel

Abstract

Systems and methods for making a custom sleep apnea mask or other wearable article are disclosed. The sleep apnea system comprises a face mask, a headband integrally connected to the face mask, and at least one air duct configured to direct air from the CPAP machine to nasal tubes. The face mask preferably comprises: an inner surface having the same shape as the user's face; an upper surface configured to sit at a first predetermined distance between the user's nose and eyes; and an outer surface configured to extend a second predetermined distance from the inner surface. Nearly shape and position of substantially all the surfaces of the mask are configured based on the shape and or location of facial features, resulting in a highly customized mask optimized for each individual patient.

1 - 5 . (canceled) 
     
     
         6 . A method of making a custom-fit article for a user, the method comprising:
 scanning at least a portion of a user's body;   generating a surface model of the portion of the user's body;   identifying a plurality of anatomical features from the surface model;   determining a first contour on the surface model based on a first anatomical feature;   determining a second contour on the surface model based on a second anatomical feature;   generating an outer surface comprising the first and second contours;   generating an inner surface comprising at least a portion of the surface model between the first and second contours; and   combining the outer surface and inner surface to form a three dimensional volume of the custom-fit article.   
     
     
         7 . A sleep apnea system configured to operate with a CPAP machine, the sleep apnea system comprising:
 a face mask comprising:
 a) an inner surface configured to contact a user, wherein the inner surface has a shape of the user's face; 
 b) an upper surface configured to sit at a first predetermined distance between the user's nose and eyes; and 
 c) an outer surface configured to extend a second predetermined distance from the inner surface; 
   a headband integrally connected to the face mask;   at least one air duct configured to direct air from the CPAP machine to the nasal tubes.   
     
     
         8 . The sleep apnea device of  claim 7 , further comprising a pliable coupling configured to:
 detachably attach to the CPAP machine, and attach to the at least one air duct.   
     
     
         9 . The sleep apnea device of  claim 7 , wherein the face mask further comprises a plurality of nasal tubes, the nasal tubes having an orientation determined based on scan data of the user. 
     
     
         10 . The sleep apnea device of  claim 7 , wherein the at least one air duct is an internal duct embedded in the headband. 
     
     
         11 . The sleep apnea device of  claim 7 , wherein the at least one air duct comprises an external duct connected to the headband. 
     
     
         12 . The sleep apnea device of  claim 11 , wherein the external duct comprises a plurality of flexible tubes. 
     
     
         13 . The sleep apnea device of  claim 7 , wherein the headband comprises: a left headband portion;
 a right head and portion; and   at least one fastener configured to detachably attach the left and right headband portions.   
     
     
         14 . The sleep apnea device of  claim 7 , wherein the face mask further includes an enclosure configured to cover a patient's mouth. 
     
     
         15 . The sleep apnea device of  claim 14 , wherein the enclosure is configured to provide a pneumatic seal around the patient's mouth. 
     
     
         16 . A custom article prepared by a process comprising the steps of:
 providing user scan data corresponding to a first body part, the user scan data comprising at least one anatomical feature of a user;   providing generic model data corresponding to a second body part; providing model data corresponding to a first article;   generating a model of the first and second body parts by combining the user scan data of the first body part with the generic model data of the second body part;   fitting the model data of the first article to the model of the first and second body parts using the at least one anatomical feature present in the user scan data of the first body part;   generating a model of a custom article tailored to the first and second body part by conforming the model data of the first article to the model of the first and second body parts; and   manufacturing a custom article from the model of the custom article.   
     
     
         17 . The custom article prepared by the process of  claim 16 , wherein the scan data corresponding to the first body part is scan data of a user face, the generic model data of the second portion of the body part is model data of a head, and the model of the first and second body parts is a substantially complete model of a head with the user face. 
     
     
         18 . The custom article prepared by a process of  claim 17 , wherein the custom article is a sleep apnea mask. 
     
     
         19 . The custom article prepared by the process of  claim 16 , wherein combining the user scan data of the first body part with the generic model data of the second body part comprises:
 aligning the generic model data of the body part with the user scan data of the first body part;   scaling the generic model data of the second body part to match the user scan data of the first body part based on tangency of surfaces represented by the generic model data and the user scan data.   
     
     
         20 . The custom article prepared by the process of  claim 19 , wherein tangency of surfaces is a rate of change of curvature at a boundary between surfaces represented by the generic model data and the user scan data. 
     
     
         21 . The custom article prepared by the process of  claim 16 , wherein fitting the model data of the first article to the model of the first and second body parts comprises:
 vertically positioning the model data of the first article relative to the model of the first and second body parts.   
     
     
         22 . The custom article prepared by the process of  claim 16 , wherein conforming the model data of the first article to the model of the first and second body part comprises:
 Boolean volume subtraction of the model data of the first article from the model of the first and second body parts, whereby the model data of the first article is configured to conform to at least a portion of the first and second body parts.   
     
     
         23 . The custom article prepared by the process of  claim 22 , wherein the model data of the first article comprises a first contour and a second contour; and wherein conforming the model data of the first article to the model of the first and second body parts comprises:
 locating at least one anatomical feature;   locating the first contour on the model of the first and second body parts based on a first one of said anatomical features; and   locating the second contour on the model of the first and second body parts based on a second one of said anatomical features.   
     
     
         24 . The custom article prepared by the process of  claim 16 , wherein conforming the model data of the first article to the model of the first and second body parts further comprises:
 generating an outer surface for the custom article, wherein the outer surface comprises the first and second contours; and   generating an inner surface for the custom article, wherein the inner surface comprises at least a portion of the user scan data between the first and second contours.