Devices to dilate nasal airways for various applications involving: activities using goggles with a helmet or goggles alone; swimming with goggles, without or with a swim cap; sleep; sleep with a cpap mask; and for physical activities

Abstract

Medical devices are disclosed as providing nasal airway dilation in subjects in need thereof whose nasal airways are partially or completely blocked, such as for sleep; with CPAP masks; for exercise; wearing goggles alone or with helmets; and for swimming. In an aspect, the devices with a group of applications provide nasal dilation to overcome obstruction caused by nasal valve dysfunction. Methods of employing the same to dilate nasal airways are further disclosed.

1 . A reusable, re-adjustable, and re-locatable air leak reducing device or nasal dilator device for a CPAP mask comprising:
 a rigid or semi-rigid housing with an integrated bridge connected thereto said housing located at any single or combination of locations over, above and below a user's nose, mouth, or any combination thereof;   a cushion liner that interfaces said housing of the mask with said user's face,   head retainer strap connected to said housing;   mounds positioned by holding means on both sides of the user's face at a location extending lateral to the user's nose at any location of the user's face to apply lateralizing and stretching forces to enhance approximation and improve seal of said CPAP mask cushion liner with the user's face, wherein said holding means for said mounds support said mounds in place to apply lateralizing and stretching forces;   varying tightening means attached to said housing providing said lateralizing and stretching forces onto said mounds, wherein when said tightening means is said strap and is adjustable to provide said lateralizing and stretching forces implemented onto said mounds, thereby transmitting said lateralizing and stretching forces onto said mounds to improve approximation for seal of said cushion liner with said user's face or to improve nasal patency of said user, and   wherein said housing and said bridge provide means for said forces to maintain said reduction in air leaks between the interface of said CPAP cushion with the user's face or to improve nasal patency to either or both sides of said user's nose.   
     
     
         2 . The device of  claim 1  further comprising a nasal or full face CPAP mask, wherein said nasal CPAP mask surrounds the nose or is positioned below the nose, and said full face CPAP mask is located over, above, or below a user's nose and/or mouth, or any combinations thereof. 
     
     
         3 . (canceled) 
     
     
         4 . The device of  claim 1  comprising said CPAP mask, wherein said head retainer strap attached to said housing provides said holding means for said mound(s) and also provides varying tightening means onto said mound(s) when said mound(s) are positioned and held between said head retainer straps and user's face. 
     
     
         5 . The device of  claim 4  with said holding means and said tightening means for said mounds, wherein said mounds located on said head retainer straps can be moved medially or laterally to contact user's face to enhance approximation and better seal of said CPAP cushion liner onto the user's face and thereby reduce air leaks between said cushion liner with user's face or to open nasal airways of a user. 
     
     
         6 - 7 . (canceled) 
     
     
         8 . The device of  claim 5  comprising said CPAP mask, wherein said mounds provide height to stretch said head retainer strap and thereby create forces onto said cushion liner to enhance approximation and better seal of said CPAP cushion liner onto the user's face and thereby reduce air leaks between said cushion liner with user's face or to open nasal airways of a user. 
     
     
         9 . The device of  claim 1  wherein said mounds are an accessory added onto said CPAP head strap with an attaching means and wherein said mounds can be retained in place with said attaching means and by holding means of said CPAP head strap. 
     
     
         10 . The device of  claim 9  wherein said attaching means is provided by strap of said mounds with means to attach around said CPAP head strap or by sliding said head retainer strap inside slots of said mounds. 
     
     
         11 - 12 . (canceled) 
     
     
         13 . The device of  claim 18  wherein said mound for said sleep or exercise mask can be an accessory or integrated into the manufacture of said sleep or exercise mask. 
     
     
         14 . The device of  claim 18  comprising said hybrid sleep or exercise mask, wherein said head retainer straps provide said holding means for said mound, and further provide varying tightening means forces onto said mound to enhance and maintain nasal passage patency. 
     
     
         15 . The device of  claim 14  further comprising a chin strap or chin cup accessory to reduce mouth opening and thereby improve nasal breathing with reduced oral-pharyngeal vibrations. 
     
     
         16 . The device of  claim 18  comprising said sleep or exercise mask, wherein said head retainer straps comprise a semi-rigid or rigid housing that can be altered in shape or size to configure to a user's size and shape of head, face or nose size, and wherein said bridge of said housing can be elevated from said user's face by increasing thickness of said mound to prevent said bridge from contacting said user's nose. 
     
     
         17 . The device of  claim 1  wherein said mounds can be compressible and be any shape. 
     
     
         18 . A reusable, re-adjustable and re-locatable sleep or exercise nasal dilator device worn on the head and face of a user comprising:
 a rigid or semi-rigid housing with an integrated bridge connected thereto said housing located at any single or combination of locations over, above, or below the user's nose;   mounds positioned by a means of holding on both sides of the user's face at a location extending lateral to the user's nose to apply lateralizing forces to pull the user's skin to open nasal passages, wherein the means of holding for said mounds support said mounds in place to apply lateralizing forces;   varying tightening means attached to said housing providing said lateralizing forces onto said mounds, wherein said tightening means forces are adjustable to provide said lateralizing forces onto said underlying skin of said user to open the user's nasal passages to improve nasal patency of said user, and wherein said housing and said bridge provide means for said forces to maintain said nasal patency to either or both sides of said user's nose.   
     
     
         19 . A method of using a reusable, adjustable, and re-locatable CPAP device to reduce air leaks or to dilate nasal passages in  claim 1 , or using a reusable, adjustable, and re-locatable device to dilate nasal passages for sleep or exercise in  claim 18 , comprising:
 providing the devices of  claims 1  and  18  to a user in need thereof;   attaching said CPAP mask onto the nose, face, or head of said user for air leak reduction or nasal dilation, or attaching said sleep or exercise mask onto nose, face, or head of said user for nasal dilation;   stretching skin of said user by varying tightening means of said devices which applies lateralizing forces onto said mound(s) to open nasal passages to improve air flow with said CPAP device and with said sleep or exercise devices;   applying increased stretching forces to reduce air leaks for said CPAP mask;   re-locating and adjusting said CPAP device and said sleep or exercise devices; and   re-using said CPAP device and said sleep or exercise devices.   
     
     
         20 . The method of  claim 19  further comprising the addition of a chin strap or chin cup to said CPAP device to reduce jaw relaxation and opening. 
     
     
         21 . The device of  claim 1  wherein said mounds can integrate reversibly or irreversibly in the manufacture of said nasal or full face mask. 
     
     
         22 . The device of  claim 1  wherein said mounds can be integrated reversibly or irreversibly located on the outside or inside of said nasal or full face mask, said mounds with increased height to enhance moments of forces by said tightening means applied to said mounds. 
     
     
         23 . The device of  claim 18  wherein the width of said bridge or length of said bridge are adjustable to change either or both dimensions to permit optimal fit for user's facial configuration. 
     
     
         24 . The device in  claim 1  further comprising a chin strap or chin cup to reduce mouth opening when wearing said CPAP mask. 
     
     
         25 . The device in  claim 2  wherein said lateralizing and stretching forces applied onto said mounds of said full face CPAP mask minimize opening of user's mouth that cause lower end of cushion liner to reposition into user's mouth.