Mask for the administration of inhaled drugs

Abstract

A breathing mask for use in administering inhalable medications to a patient in need of an inhaled drug is provided. The mask disclosed herein is particularly useful for use with very young children. The mask is made from a flexible molded plastic silicone or elastomeric material, and has an anthropometrically/anatomically/ergonomically contoured shape to provide a good seal, a comfortable fit, and minimal dead space within the mask. The airway is aligned with nose. There may be an orifice for use with a soother device to calm a child using the mask. Also provided is a visual flow indicator to provide an indication of the quality of the seal of the mask on the face.

1 . A mask for administering an inhalable medication to a patient, comprising:
 a flexible ergonomically shaped molded elastomer face mask body covering the nose and mouth of the patient, comprising a nose section and a mouth section, wherein the edge of the mask in contact with the patient's face is a thin soft lip in contact with the face of the patient;   wherein the edge of the mask in contact with the face is contoured with at least one inflection point of at least approximately 10°;   a drug delivery path aligned with the nose of the patient comprising an opening for receiving an inhalable medication in the nose section of the mask configured to minimize the dead space in the mask; and   an ergonomically contoured mouth section shaped to fit close to the mouth and lips of the patient with minimal dead space in the mouth section.   
     
     
         2 . The mask of  claim 1  wherein the lip is angled outward with respect to the interior of the mask. 
     
     
         3 . A mask for administering an inhalable medication to a patient, comprising:
 a. a flexible ergonomically shaped molded elastomer face mask body covering the nose and mouth of the patient, comprising a nose section and a mouth section, wherein the edge of the mask in contact with the patient's face is a thin soft lip in contact with the face of the patient angled outward from the interior of the mask;   b. wherein the edge of the mask in contact with the face is contoured with at least one inflection point of at least approximately 10°;   c. a drug delivery path aligned with the nose of the patient comprising an opening for receiving an inhalable medication in the nose section of the mask configured to minimize the dead space in the mask; and   d. an ergonomically contoured mouth section shaped to fit close to the mouth and lips of the patient with minimal dead space in the mouth section.   
     
     
         4 . The mask of  claim 1 , wherein said mask is intended for use with children of age newborn to about five years old. 
     
     
         5 . The mask of  claim 1 , wherein said mask is intended for use with children of age newborn to about five years old, further comprising an orifice in the mouth section within which a soother device can be inserted. 
     
     
         6 . The mask of  claim 5  wherein a soother device is inserted 
     
     
         7 . The mask of  claim 1 , wherein said mask is intended for use with children of age newborn to about five years old, further comprising a thin region in the mouth section that can be cut or punctured to create an orifice for a soother device. 
     
     
         8 . The mask of  claim 7 , wherein a soother device is inserted. 
     
     
         9 . A mask for administering inhaled medications to a patient, comprising:
 a. a flexible ergonomically shaped molded elastomer face mask body covering the nose and mouth of the patient, comprising a nose section and a mouth section, wherein the edge of the mask in contact with the patient's face is a thin soft lip;   b. wherein the edge of the mask in contact with the face is contoured with at least one inflection point of at least approximately 10°;   c. a drug delivery path aligned with the nose of the patient comprising an opening for receiving an inhalable medication in the nose section of the mask configured to minimize the dead space in the mask;   d. an ergonomically contoured mouth section shaped to fit close to the mouth and lips of the patient with minimal dead space in the mouth section; and   e. an orifice in the mouth section within which a soother device can be inserted.   
     
     
         10 . The mask of  claim 9  wherein the patient is a person selected from the group consisting of newborn infants up to age about five years. 
     
     
         11 . The mask according to  claim 1 , further comprising a biofeedback system comprising an exhalation valve comprising a flow indicator mounted adjacent to the nostrils of the patient, wherein the flow indicator moves in response to the exhalation by the patient thereby providing a visual indication of the quality of the seal around the face of the patient. 
     
     
         12 . The mask according to  claim 11 , wherein the visual indicator is a colored flap that moves in response to the breathing of the patient during a secured seal. 
     
     
         13 . The mask of  claim 1 , wherein the size of the mask is selected from the group of dimensions comprising about 59 mm wide and about 64 mm high; about 71 mm wide and about 76 mm high; and about 82 mm wide and about 87 mm high. 
     
     
         14 . The mask of  claim 1 , wherein dead space within the mask is minimized by the contour of the mask to the face and the alignment of the airway with the nostrils. 
     
     
         15 . The mask of  claim 9 , wherein the soother device orifice comprises a duck bill-type orifice within a flexible accordion section and is situated on the face of the mouth section of the mask. 
     
     
         16 . The mask of  claim 9 , wherein the soother device orifice is a modified duck bill that effectively seals the opening to prevent leakage of air during inhalation or exhalation when a soother device is inserted into the orifice. 
     
     
         17 . The mask of  claim 9 , wherein the soother device orifice is within a flexible section of the face of the mask, permitting the soother device to shift position relative to the airway of the mask, such that the soother device fits comfortably within the mouth of the patient, and wherein the orifice provides a suitable air seal. 
     
     
         18 . The mask of  claim 9 , wherein the soother device orifice is within a flexible section of the face of the mask, permitting the soother device to shift position relative to the airway of the mask, such that the soother device fits comfortably within the mouth of the patient, without substantially deforming the main body such that the seal of the mask on the face of the patient is breached. 
     
     
         19 . The mask of  claim 1 , wherein the mask is held in position during the administration of medication by a caregiver or by the hand of the patient. 
     
     
         20 . The mask of  claim 1  wherein the edge of the mask in contact with the face is contoured with at least three inflection points of at least approximately 10°. 
     
     
         21 . The mask of  claim 1  wherein the source of the inhalable medication is a metered dose inhaler or a nebulizer. 
     
     
         22 . The mask of  claim 1  wherein the source of the inhalable medication is a metered dose inhaler and a holding chamber is used. 
     
     
         23 . The mask of  claim 1  wherein the inhalable medication is a gas, a vapor, a mist, an aerosol, or a suspended powder. 
     
     
         24 . A method of administering an inhalable medicament to a patient using the mask according to  claims 1 . 
     
     
         25 . A method of administering an inhalable medicament to a patient of age birth to about five years using the mask according to  claims 1 . 
     
     
         26 . A method of administering an inhalable medicament to a person of age birth to five years using the mask according to  claim 9 , wherein a soother device is used.