Inhalation therapy device for use in premature babies and infants

Abstract

For use in premature babies and infants, in particular for administering surfactant to the lungs, the inhalation therapy device described herein comprises an aerosol generating device 1 , a respiratory air flow generating means 3 and a nebulising chamber 5 into which the generated liquid droplets 2 and the respiratory air flow 4 are supplied. The nebulising chamber 5 comprises a tapering area 52 which ends in a tubular intubation means 6 . The intubation means 6 is designed such that the intubation end 6 b can be positioned in such a manner that the liquid droplet/respiratory air mixture conveyed via the intubation means is released behind those areas of the respiratory tract that filter out to a great extent the liquid droplets from the mixture.

1 . Inhalation therapy device comprising:
 an aerosol generating device having a membrane and a piezo-oscillator that causes the membrane to oscillate for nebulising a fluid and providing liquid droplets;   a nebulising chamber having a respiratory air supply opening to which a respiratory air flow is to be supplied and an area comprising a connecting piece to discharge a liquid droplet/respiratory air mixture formed by supplying liquid droplets and the respiratory air flow to the nebulising chamber, wherein   the inhalation therapy device is configured to alternately switch the aerosol generating device on/off by means of an activation signal to the piezo-oscillator and to adjust the on/off switching phases, whereby the output rate of the aerosol generating device is adjustable.   
     
     
         2 . Inhalation therapy device according to  claim 1 , wherein the inhalation therapy device is configured to adjust the on/off switching phases so that a phase with an increased output rate precedes a phase with a reduced output rate. 
     
     
         3 . Inhalation therapy device according to  claim 1 , wherein the aerosol generating device is disposed in the nebulizing chamber and aligned relative to said area so that the liquid droplets are supplied directly to the nebulizing chamber in a direction towards said area, wherein respiratory air flow flows around the aerosol generating device, whereby a sheath-like respiratory air flow surrounds the generated liquid droplets and the liquid droplets and the respiratory air flow mix forming the liquid droplet/respiratory air mixture. 
     
     
         4 . Inhalation therapy device according to  claim 1 , wherein the aerosol generating device comprises a controller configured to control the aerosol generation of said aerosol generating device. 
     
     
         5 . Inhalation therapy device according to  claim 4 , wherein the controller is connected to the piezo-oscillator and the controller is configured to perform a pulsed operation in which aerosol generating phases and resting phases alternate by switching the piezo-oscillator on/off. 
     
     
         6 . Inhalation therapy device according to  claim 4 , wherein the controller is configured to alternately switch the aerosol generating device on/off by means of the activation signal to the piezo-oscillator and to adjust the on/off switching phases. 
     
     
         7 . Inhalation therapy device according to  claim 4 , wherein the controller is configured to adjust the on/off switching phases so that a phase with an increased output rate precedes a phase with a reduced output rate. 
     
     
         8 . Method of administering a substance, preferably a medicament, using an inhalation therapy device according to  claim 1 , wherein an administration strategy is used. 
     
     
         9 . Method according to  claim 8 , wherein the administration strategy comprises a first phase in which the aerosol generator is operated with a first output rate and a second phase in which the aerosol generator is operated with a second output rate, the first output rate being greater than the second output rate. 
     
     
         10 . Method according to  claim 9 , wherein the first output rate is designed for the greatest possible deposition rate of aerosol in the lungs and the second output rate is designed to optimise delivery efficiency of the active substance. 
     
     
         11 . Method according to  claim 9 , wherein the first and second output rates can be applied and combined as desired in order to optimise each expedient/required administration strategy. 
     
     
         12 . Method according to  claim 8 , wherein a medicament selected from the group consisting of lung surfactant, antibiotics, anti-inflammatory agents including steroids and non-steroids, betamimetics and endogenous substances including alpha 1-antitrypsin, interferons and insulin. 
     
     
         13 . Method according to  claim 8 , wherein a medicament of a volume of 0.3 ml to 10 ml is nebulized. 
     
     
         14 . Method according to  claim 8 , wherein a medicament of a volume of 0.5 ml to 5 ml is nebulized. 
     
     
         15 . Method according to  claim 8 , wherein an aerosol formed by the liquid droplets has a mass median diameter (MMD) of less than 5 μm. 
     
     
         16 . Method according to  claim 8 , wherein an aerosol formed by the liquid droplets has a mass median diameter (MMD) of less than 3.5 μm. 
     
     
         17 . Method according to  claim 8 , wherein an aerosol formed by the liquid droplets with a narrowband droplet distribution is generated, which is distinguished by a geometric standard deviation of less than 2. 
     
     
         18 . Method according to  claim 8 , wherein an aerosol formed by the liquid droplets with a narrowband droplet distribution is generated, which is distinguished by a geometric standard deviation of less than 1.6.