Delivery Device and Method

Abstract

A nasal delivery device for and method of delivering substance to the middle meatus in a nasal cavity of a subject in the treatment of a condition, in particular an inflammatory or infectious condition, thereof, the delivery device comprising: a nosepiece unit including a nosepiece for fitting to a nostril of a subject and a nozzle through which substance is in use delivered to the respective nasal cavity; and a delivery unit for delivering substance through the nozzle of the nosepiece; wherein the delivery device is configured to provide for deposition of a significant fraction of the delivered dose on, around and in the vicinity of the middle meatus.

1 - 252 . (canceled) 
     
     
         253 . A method of delivering fluticasone to the middle meatus in one, first nasal cavity of a subject in the treatment of rhinosinusitis, the method comprising:
 fitting a first nosepiece unit to one, first nostril of a subject, wherein the first nosepiece unit includes a nosepiece which is inserted into the first nostril, and a nozzle through which fluticasone is delivered to the first nasal cavity from a first substance supply unit;   providing a first mouthpiece unit which includes a mouthpiece, wherein the mouthpiece of the first mouthpiece unit is fluidly connected to the nosepiece of the first nosepiece unit;   the subject exhaling through the mouthpiece of the first mouthpiece unit so as to cause closure of the oropharyngeal velum of the subject and deliver an air flow through the first nostril, around the posterior margin of the nasal septum and out of the other, second nostril of the subject; and   delivering, during exhalation through the mouthpiece of the first mouthpiece unit, a liquid aerosol spray comprising a dose of fluticasone from the first substance supply unit through the nozzle of the first nosepiece unit into the first nasal cavity;   wherein at least 50% of the dose as initially deposited in the nasal airway is deposited in a region of the first nasal cavity which is posterior of the nasal valve and at least 30% of the dose as initially deposited in the nasal airway is deposited in an upper posterior region of the first nasal cavity which is posterior of the nasal valve and above the inferior meatus.   
     
     
         254 . The method  claim 253 , wherein inserting the nosepiece obstructs the nasal valve so as to obstruct a nasal passage anteriorly of the nasal valve. 
     
     
         255 . The method of  claim 253 , wherein inserting the nosepiece closes the nasal valve, preventing deposition of fluticasone anteriorly of the nasal valve. 
     
     
         256 . The method of  claim 253 , wherein the aerosol spray has a cone angle of not more than 50 degrees. 
     
     
         257 . The method of  claim 253 , wherein the aerosol spray has a cone angle of not more than 40 degrees. 
     
     
         258 . The method of claim  1253 , further comprising:
 manually actuating the substance supply unit to release the dose.   
     
     
         259 . The method of  claim 253 , wherein at least 55% of the dose as initially deposited in the nasal airway is deposited in the region posterior of the nasal valve. 
     
     
         260 . The method of  claim 253 , wherein at least 60% of the dose as initially deposited in the nasal airway is deposited in the region posterior of the nasal valve. 
     
     
         261 . The method of  claim 253 , wherein at least 35% of the dose as initially deposited in the nasal airway is deposited in the upper posterior region thereof. 
     
     
         262 . The method of  claim 253 , wherein at least 40% of the dose as initially deposited in the nasal airway is deposited in the upper posterior region thereof. 
     
     
         263 . The method of  claim 253 , wherein at least 45% of the dose as initially deposited in the nasal airway is deposited in the upper posterior region thereof. 
     
     
         264 . The method of  claim 253 , wherein at least 50% of the dose as initially deposited in the nasal airway is deposited in the upper posterior region thereof. 
     
     
         265 . The method of  claim 253 , wherein the nosepiece is inserted into the first nostril such that the nosepiece extends into the nasal valve and provides for expansion of the nasal valve. 
     
     
         266 . The method of  claim 253 , further comprising:
 fitting a second nosepiece unit to the second nostril, wherein the second nosepiece unit includes a nosepiece which is inserted into the second nostril, and a nozzle through which fluticasone is delivered to the second nasal cavity from a second substance supply unit;   providing a second mouthpiece unit which includes a mouthpiece, wherein the mouthpiece of the second mouthpiece unit is fluidly connected to the nosepiece of the second nosepiece unit;   the subject exhaling through the mouthpiece of the second mouthpiece unit so as to cause closure of the oropharyngeal velum of the subject and deliver an air flow through the second nostril, around the posterior margin of the nasal septum and out of the first nostril; and   delivering, during exhalation though the mouthpiece of the second mouthpiece unit, a liquid aerosol spray comprising a dose of fluticasone from the second substance supply unit through the nozzle of the second nosepiece unit into the second nasal cavity;   wherein at least 50% of the dose as initially deposited in the nasal airway is deposited in a region of the second nasal cavity which is posterior of the nasal valve and at least 30% of the dose as initially deposited in the nasal airway is deposited in an upper posterior region of the second nasal cavity which is posterior of the nasal valve and above the inferior meatus.   
     
     
         267 . The method of  claim 266 , wherein a single nosepiece unit is used as the first and second nosepiece units, a single mouthpiece unit is used as the first and second mouthpiece units, and a single substance supply unit is used as the first and second substance supply units. 
     
     
         268 . The method of  claim 267 , wherein the single substance supply unit comprises a multi-dose pump unit for delivery a plurality of metered doses of fluticasone, each dose being delivered in response to a single actuation of the multi-dose pump unit. 
     
     
         269 . The method of  claim 253 , wherein the rhino sinusitis comprises chronic rhinosinusitis. 
     
     
         270 . A method of delivering fluticasone to the middle meatus of each of first and second nasal cavities of a subject in the treatment of rhinosinusitis, the method comprising:
 fitting a nosepiece unit to one, first nostril of a subject, wherein the nosepiece unit includes a nosepiece which is inserted into the first nostril to extend into the nasal valve and expand the nasal valve, and a nozzle through which fluticasone is delivered to the first nasal cavity from a substance supply unit;   providing a mouthpiece unit which includes a mouthpiece, wherein the mouthpiece is fluidly connected to the nosepiece;   the subject exhaling through the mouthpiece so as to cause closure of the oropharyngeal velum of the subject and deliver an air flow through the first nostril, around the posterior margin of the nasal septum and out of the other, second nostril of the subject; and   delivering, during exhalation though the mouthpiece, a liquid aerosol spray comprising a dose of fluticasone from the substance supply unit through the nozzle into the first nasal cavity;   wherein at least 50% of the dose as initially deposited in the nasal airway is deposited in a region of the first nasal cavity which is posterior of the nasal valve and at least 30% of the dose as initially deposited in the nasal airway is deposited in an upper posterior region of the first nasal cavity which is posterior of the nasal valve and above the inferior meatus;   fitting the nosepiece unit to the second nostril, wherein the nosepiece is inserted into the second nostril to extend into the nasal valve and expand the nasal valve;   the subject exhaling through the mouthpiece so as to cause closure of the oropharyngeal velum of the subject and deliver an air flow through the second nostril, around the posterior margin of the nasal septum and out of the first nostril; and   delivering, during exhalation through the mouthpiece, a liquid aerosol spray comprising a dose of fluticasone from the substance supply unit through the nozzle into the second nasal cavity;   wherein at least 50% of the dose as initially deposited in the nasal airway is deposited in a region of the second nasal cavity which is posterior of the nasal valve and at least 30% of the dose as initially deposited in the nasal airway is deposited in an upper posterior region of the second nasal cavity which is posterior of the nasal valve and above the inferior meatus.   
     
     
         271 . A method of delivering fluticasone to the middle meatus in one, first nasal cavity of a subject in the treatment of rhinosinusitis, the method comprising:
 fitting a nosepiece unit to one, first nostril of a subject, wherein the nosepiece unit includes a nosepiece which is inserted into the first nostril to extend into the nasal valve and expand the nasal valve, and a nozzle through which fluticasone is delivered to the first nasal cavity from a multi-dose pump unit;   providing a mouthpiece unit which includes a mouthpiece, wherein the mouthpiece is fluidly connected to the nosepiece;   the subject exhaling through the mouthpiece so as to cause closure of the oropharyngeal velum of the subject and deliver an air flow through the first nostril, around the posterior margin of the nasal septum and out of the other, second nostril of the subject; and   delivering, during exhalation through the mouthpiece, a liquid aerosol spray comprising a metered dose of fluticasone from the multi-dose pump unit through the nozzle of the nosepiece unit into the first nasal cavity;   wherein at least 50% of the dose as initially deposited in the nasal airway is deposited in a region of the first nasal cavity which is posterior of the nasal valve and at least 30% of the dose as initially deposited in the first nasal airway is deposited in an upper posterior region of the first nasal cavity which is posterior of the nasal valve and above the inferior meatus.   
     
     
         272 . The method of  claim 271 , wherein the rhinosinusitis comprises chronic rhinosinusitis.