Inhalation nebulizer

• US 20080299049A1
• Filed: 11/30/2007
• Published: 12/04/2008
• Est. Priority Date: 11/30/2006
• Status: Active Grant

• Current Assignee: PARI Pharma GmbH (PARI MEDICAL HOLDING GmbH)
• Original Assignee: PARI Pharma GmbH (PARI MEDICAL HOLDING GmbH)
• Inventors: Stangl, Roland
• Granted Patent: US 8,387,895 B2
• Time in Patent Office: Days
• US Class Current: 424/45
• CPC Class Codes: A61M 15/0015 located upstream of the dispenser, i.e. not traversed by the product
• CPC Class Codes: A61M 15/0018 with exhalation check valves
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/0086 Inhalation chambers

Abstract

The aerosol generator of an inhalation therapy device according to a preferred embodiment of the invention continuously produces an aerosol at a generation rate of about 0.2 ml/min to about 1.5 ml/min, preferably 0.4 ml/min to about 1.2 ml/min and the mixing chamber has a volume of about 60 ml to about 150 ml, preferably about 80 ml to about 120 ml, and even more preferably about 90 to about 110 ml. While the patient inhales through the inhalation therapy device, the generated aerosol is inhaled by the patient. While the patient exhales into the inhalation therapy device, the generated aerosol is collected in the mixing chamber. Due to the specific size of the mixing chamber, the continuously generated aerosol can accumulate therein without losses even when the exhalation phase is longer than the inhalation phase like in the case of emphysema.

Claims

1. An inhalation therapy device comprising

a liquid storage container into which a liquid can be filled;

an aerosol generator comprising;

a membrane which is arranged with respect to the liquid storage container such that a liquid filled into the liquid storage container comes into contact with one side of the membrane; and

a vibration generator capable of causing the membrane to vibrate such that a liquid filled into the liquid storage container is nebulized and expelled as an aerosol on the other side of the membrane through openings of the membrane at an aerosol generation rate in the range of about 0.2 ml/min to about 1.5 ml/min;

a mixing chamber into which the aerosol generator delivers the aerosol and which has a volume in the range of about 60 ml to about 150 ml;

an inhalation valve that is open to allow an inflow of ambient air into the mixing chamber during an inhalation phase and is closed to prevent escape of the aerosol from the mixing chamber during an exhalation phase; and

an exhalation valve that is open to allow the discharge of the respiratory air of a patient into the surroundings during the exhalation phase and is closed to prevent the inflow of ambient air during the inhalation phase.

2. The inhalation therapy device of claim 1, wherein the aerosol generator is adapted to produce an aerosol having a mass median aerodynamic diameter (MMD) that ranges from about 1 μ

m to about 6 μ

m.

3. The inhalation therapy device of claim 1, wherein the membrane forms a part of the wall of the liquid storage container and partially defines the liquid storage container such that a liquid filled into the liquid storage container directly contacts the membrane.

4. The inhalation therapy device of claim 1, wherein the aerosol generator comprises a ring-shaped disk which is arranged to support the membrane and to which a ring-shaped piezo-electric disk is attached concentrically.

5. The inhalation therapy device of claim 1, wherein the exhalation valve is arranged at a mouthpiece which is removably mounted at the mixing chamber and through which the patient inhales the aerosol from the mixing chamber.

6. The inhalation therapy device of claim 1, wherein the exhalation valve is arranged in a wall of the mixing chamber.

7. The inhalation therapy device of claim 1, wherein the liquid consists of or contains a drug effective against any pulmonary disease such as asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, lung infections, pulmonary and cystic fibrosis, sarcoidosis, bronchiolitis obliterans, hormone or enzyme or neurotransmitter deficiency, pulmonary hypertension and other parenchymatic or non parchenchymatic diseases affecting uptake and exchange of air in the lungs.

8. The inhalation therapy device of claim 7, wherein the drug consists of or comprises alpha anti-trypsine (A1AT)

9. The inhalation therapy device of claim 1, wherein the liquid consists of or contains any drug out of the following drug classes:

antibiotics, antifungals, immunmodulators, beta-agonists, cytostatic drugs, steroids, xanthines, non-steroidal anti-inflammatory drugs, mucolytics, proteins, peptides, genes or other drug compounds or medications suitable for treating pulmonary diseases.

10. The inhalation therapy device of claim 1, wherein the liquid consists of or contains any drug out of the following drug classes:

genes, small and large molecule proteins and peptides, pain-killers, hormones, opiates, anti cancer drugs, canabinoids or other drug compounds or medications suitable for systemic delivery via the lungs.

11. The inhalation therapy device of claim 9, wherein the drug may be formulated as solid (lyophylisates, powders) or liquid drug products, such as solutions, suspensions, emulsions, colloidal systems or liposomes, all for administration as liquid aerosols.

12. The inhalation therapy device of claim 1, wherein the vibration generator is capable of causing the membrane to vibrate such that a liquid filled into the liquid storage container is nebulized and expelled as an aerosol on the other side of the membrane through openings of the membrane at an aerosol generation rate in the range of about 0.4 ml/min to about 1.2 ml/min.

13. The inhalation therapy device of claim 1, wherein the mixing chamber has a volume in the range of about 80 ml to about 120 ml.

14. The inhalation therapy device of claim 1, wherein the mixing chamber has a volume in the range of about 90 ml to about 110 ml.