AEROSOL THERAPY DEVICE WITH HIGH FREQUENCY DELIVERY

• US 20110120456A1
• Filed: 02/13/2009
• Published: 05/26/2011
• Est. Priority Date: 02/15/2008
• Status: Active Grant

• Current Assignee: Nasologix, LLC
• Original Assignee: Nasologix, LLC
• Inventors: Immel, Timothy Sean
• Granted Patent: US 8,899,230 B2
• Time in Patent Office: Days
• US Class Current: 128/200.23
• CPC Class Codes: A61M 15/0085 using ultrasonics spraying or atomising liquids using ultrasonic vibrations in general B05B17/06
• CPC Class Codes: A61M 15/0098 Activated by exhalation
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose

Abstract

The present invention relates to an aerosol therapy device, wherein an aerosol is generated in an aerosol generating device and is supplied through a nosepiece to a patient'"'"'s nasal cavities via a single pulsed main aerosol flow.

Claims

1. An aerosol therapy device for delivery of an active agent to the paranasal sinuses comprising:

(a) an aqueous drug reservoir, said aqueous drug reservoir being connected to

(b) an aerosol generator for the generation of aerosol particles, said aerosol generator being connected to

(c) an air-flow supply device, said air-flow supply device producing a single airflow to carry said aerosol particles of (b), wherein said single airflow consists of a pulsating flow of air and comprises a pressure field produced by a pulsed pressure wave, wherein said pulsating airflow pulsates at a frequency greater than 100 Hz; and

(d) a nosepiece to direct said single airflow comprising aerosol particles of (c) into one of the two alae of the nose,

whereby said aerosol therapy device delivers aerosol particles comprising an active agent to the paranasal sinuses.

2. The aerosol therapy device of claim 1, wherein said air-flow supply device of (c) is selected from a mechanical pump, and pneumatic pump or an electric pump.

3. The aerosol therapy device of claim 1, wherein said air-flow supply device of (c) is a mechanical pump.

4. The aerosol therapy device of claim 1, wherein said air-flow supply device of (c) is a pneumatic pump.

5. The aerosol therapy device of claim 1, wherein said air-flow supply device of (c) is an electric pump.

6. The aerosol therapy device of claim 5, wherein said air-flow supply device of (c) is a piezoelectric pump.

7. The aerosol therapy device of claim 1, wherein said aerosol generator of (b) is selected from the group consisting of a pulsating membrane device, a device comprising a vibrating mesh or plate with multiple apertures, a thin-film resistive heater with a diaphragm membrane, or a device comprising a vibration generator.

8. The aerosol therapy device of claim 1, wherein said aerosol particles have a mass-median aerodynamic diameter (MMAD) of from about 0.5 μ

m to about 150.0 μ

m, from about 20 μ

m to about 150.0 μ

m, from about 0.5 μ

m to about 10 μ

m, from 5 μ

m to about 20 μ

m, from about 20 μ

m to about 150 μ

m, from about 20 μ

m to about 50 μ

m, or from about 50 μ

m to about 150 μ

m.

9. The aerosol therapy device of claim 1, wherein said aerosol particles have a mass-median aerodynamic diameter (MMAD) of from about 2.0 μ

m to about 8.0 μ

m.

10. The aerosol therapy device of claim 1, wherein said aerosol particles have a mass-median aerodynamic diameter (MMAD) of from about 3.0 μ

m to about 5.0 μ

m.

11. The aerosol therapy device of claim 1, wherein said pressure field of (c) is an acoustic pressure field.

12. The aerosol therapy device of claim 1, wherein said pulsating airflow pulsates at a frequency from about 150 Hz to about 20 KHz.

13. The aerosol therapy device of claim 1, wherein said pulsating airflow pulsates at a frequency from about 150 Hz to about 10 KHz.

14. The aerosol therapy device of claim 1, wherein said pulsating airflow pulsates at a frequency from about 150 Hz to about 6000 Hz

15. The aerosol therapy device of claim 1, wherein said pulsating airflow pulsates at a frequency from about 300 Hz to about 4000 Hz.

16. The aerosol therapy device of claim 1, wherein said pulsating airflow pulsates at a frequency from about 500 Hz to about 3000 Hz.

17. The aerosol therapy device of claim 1, wherein said pulsating airflow pulsates at a frequency from about 150 Hz to about 1100 Hz.

18. The aerosol therapy device of claim 1, wherein said single airflow consists of a pulsating flow of air comprises a pressure field ranging from about 5 to about 50 mbar.

19. The aerosol therapy device of claim 1, wherein said single airflow consists of a pulsating flow of air comprises a pressure field ranging from about 15 to about 40 mbar.

20. The aerosol therapy device of claim 1, wherein said single airflow consists of a pulsating flow of air comprises a pressure field ranging from about 15 to about 30 mbar.

21. The aerosol therapy device of claim 1, wherein said device has can deliver a therapeutically effective dose of an active agent to the paranasal sinuses in less than about 10 minutes.

22. The aerosol therapy device of claim 1, wherein said device has can deliver a therapeutically effective dose of an active agent to the paranasal sinuses in less than about 5 minutes.

23. The aerosol therapy device of claim 1, wherein said device has can deliver a therapeutically effective dose of an active agent to the paranasal sinuses in less than about 4 minutes.

24. The aerosol therapy device of claim 1, wherein said device has can deliver a therapeutically effective dose of an active agent to the paranasal sinuses in less than about 3 minutes.

25. The aerosol therapy device of claim 1, wherein said device has can deliver a therapeutically effective dose of an active agent to the paranasal sinuses in less than about 2 minutes.

26. The aerosol therapy device of claim 1, wherein said device has can deliver a therapeutically effective dose of an active agent to the paranasal sinuses in less than about 1 minute.

28. The aerosol therapy device of claim 1, wherein said active agent is an aqueous formulation having a volume of less than about 4 mls.

29. The aerosol therapy device of claim 1, wherein said active agent is an aqueous formulation having a volume of less than about 3 mls.

30. The aerosol therapy device of claim 1, wherein said active agent is an aqueous formulation having a volume of less than about 2 mls.

31. The aerosol therapy device of claim 1, which further comprises a breath trigger or a breath actuator.

32. The aerosol therapy device of claim 1, wherein said nose piece of (d) is a twin-port nose piece.

33. The aerosol therapy device of claim 1, wherein said airflow comprising aerosol particles of (c) is directed into one of the two alae of the nose in an alternating fashion.

34. The aerosol therapy device of claim 33, wherein said alternating airflow alternates between said one of the two alae at 30 second intervals.

35. The aerosol therapy device of claim 1, wherein in said device is self-tuning.

36. The aerosol therapy device of claim 1, wherein said device can sweep a range of frequencies to determine the optimum pulsating frequency to obtain delivery of said active agent to the paranasal sinuses.

37. The aerosol therapy device of claim 36, wherein said device sweeps a range of frequencies from about 150 Hz to about 6000 Hz.

38. The aerosol therapy device of claim 36, wherein said device sweeps a range of frequencies from about 150 Hz to about 2500 Hz.

39. The aerosol therapy device of claim 36, wherein said device sweeps a range of frequencies from about 300 Hz to about 4000 Hz.

40. The aerosol therapy device of claim 36, wherein said device sweeps a range of frequencies from about 500 Hz to about 3000 Hz.

41. A method of treating sinusitis using the aerosol therapy device of claim 1, wherein said active agent is selected from the group consisting of anti-inflammatory drugs, glucocorticoids, anti-infective agents, antibiotics, and fungicides.

27. The aerosol therapy device of claim I, wherein said active agent is an aqueous formulation having a volume of less than about 5 mls.

42. An aerosol therapy device for intranasal delivery of an active agent to the central nervous system via the olfactory region of the nasal passages to a patient in need thereof comprising:

(a) an aqueous drug reservoir, said aqueous drug reservoir being connected to

(b) an aerosol generator for the generation of aerosol particles, said aerosol generator being connected to

(c) an air-flow supply device, said air-flow supply device producing a single airflow to carry said aerosol particles of (b), wherein said single airflow consists of a pulsating flow of air and comprises a pressure field produced by a pulsed pressure wave; and

(d) a twin-port nosepiece to simultaneously direct said single airflow comprising aerosol particles of (c) into both alae of the nose,

whereby said aerosol therapy device intranasally delivers aerosol particles comprising an active agent to the olfactory region of the nasal passages.

43. A method of treating a disorder of the central nervous system using the aerosol therapy device of claim 42, wherein said active agent is selected from the group consisting of melanocortin-4 receptor, nerve growth factor, ganglioside, phosphatidylserine, brain-derived neurotrophic factor, fibroblast growth factor, insulin, insulin-like growth factors, ciliary neurotrophic factor glia-derived nexin, cholinergic enhancing factors such as phosphoethanolamine and thyroid hormone T.3, thyrotropin-releasing hormone and analogues, endogenous central nervous system tripeptide, butorphanol tartarate, desmopressin acetate, nafarelin acetate, DHE-45 dihydroergotamine, zolmitriptan, scopolamine hydrobromide, buprenorphine hydrochloride, chlorpheniramine maleate, chlorphenpyridamine maleate, prophenpyridamine maleate, clonazepam, diphenylhydramine hydrochloride, doxylamine succinate, ergotamine tartarate, metoclopramide hydrochloride, midazolam, neostigmine bromide, nicotine, propanolol hydrochloride, sufentil citrate, and vasopressin.

44. An aerosol therapy device for systemic delivery of an active agent to the nasal passages and/or sinuses of a patient in need thereof comprising:

(a) an aqueous drug reservoir, said aqueous drug reservoir being connected to

(b) an aerosol generator for the generation of aerosol particles, said aerosol generator being connected to

(c) an air-flow supply device, said air-flow supply device producing a single airflow to carry said aerosol particles of (b), wherein said single airflow consists of a pulsating flow of air and comprises a pressure field produced by a pulsed pressure wave; and

(d) a nosepiece to direct said single airflow comprising aerosol particles of (c) into one or both alae of the nose,

whereby said aerosol therapy device delivers aerosol particles comprising an active agent to the nasal passages and/or sinuses.

45. A method for the systemic delivery of an active agent for the treatment of a disorder using the aerosol therapy device of claim 44, wherein said disorder is selected from endocrine and metabolic disorders, migraines, sleep disorders, autoimmune diseases, osteoporosis, neurological diseases and disorders, pain, nausea and vomiting, obesity, sexual dysfunctions, cardiovascular diseases and episodes, herpes, sarcoidosis, fibrosis, cancer, or autoimmune reaction.