Integrated nebulizer and particle dispersion chamber for nasal delivery of medicament to deep nasal cavity and paranasal sinuses

• US 20070131224A1
• Filed: 09/03/2004
• Published: 06/14/2007
• Est. Priority Date: 09/05/2003
• Status: Active Grant

• Current Assignee: Savine Therapeutics Pty
• Original Assignee: Kurve Technology, Inc.
• Inventors: Giroux, Marc
• Granted Patent: US 8,001,963 B2
• Time in Patent Office: Days
• US Class Current: 128/200.210
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2206/14 Static flow deviators in tubes disturbing laminar flow in tubes, e.g. archimedes screws

Abstract

Particular aspects provide a novel integrated nebulizer and particle dispersion chamber (12), and novel methods of using same. Preferably, the particle dispersion chamber (12) provides for delivery of a vortical flow of nebulized particles to the notrils. The inventive integrated nebulizer, delivery methods and breathing techniques allow for delivering medicament into the deep nasal cavity and paranasal sinuses of a user. Significantly, the inventive devices and methods allow for systemic and topical delivery of medicaments via the membranes of the nasal cavity and paranasal sinuses. Additional preferred embodiments provide complementary cartridge docking system that allows for user-specific nebulized drug delivery.

Claims

1. A nebulizer suitable for topical drug delivery to, or systemic drug delivery via, a deep nasal cavity or paranasal sinus, comprising:

a nasal adapter having nasal proximal and nasal distal ends, and having at least one adapter channel communicating between an aperture in the nasal-proximal end and an aperture in the nasal-distal end;

a particle dispersion chamber, integral or in direct communication with the nasal adapter, and comprising;

a dispersion chamber wall having an external and an internal surface, the internal surface defining at least one internal dispersion channel, the internal dispersion channel comprising the nasal adapter channel; and

a compressed fluid output channel in communication with the internal dispersion channel;

a nebulizing chamber, integral or in direct communication with the particle dispersion chamber, and comprising;

a nebulizing chamber wall; and

nebulizing means with at least one pressure release orifice suitable to produce a nebulized particle stream;

a nebulizing pressure feed having a compressor channel in communication with the pressure release orifice of the nebulizing chamber; and

a dispersion feed channel communicating between the nebulizing pressure feed and the fluid output channel of the particle dispersion chamber, the nebulizer suitable to deliver a dispersed flow of nebulized particles to a nasal orifice.

2. The nebulizer of claim 1, wherein the compressed fluid output channel is integral with the dispersion chamber wall.

3. The nebulizer of claim 1, wherein the compressed fluid output channel communicates with the nasal adaptor portion of the internal dispersion channel.

4. The nebulizer of claim 1, comprising a plurality of compressed fluid output channels in communication with at least one dispersion feed channel.

5. The nebulizer of claim 1, wherein the dispersion feed channel is integral with at least one of the nebulization chamber wall and the dispersion chamber wall.

6. The nebulizer of claim 1, wherein dispersed particle flow of nebulized particles comprises vortical particle flow thereof.

7. The nebulizer of claim 1, comprising:

a single nebulizer pressure release orifice; and

dual internal dispersion channels comprising corresponding dual nasal adapter channels.

8. The nebulizer of claim 1, comprising:

dual nebulizer pressure release orifices; and

dual internal dispersion channels comprising corresponding dual nasal adapter channels.

9. The nebulizer of any one of claims 8 or 9, wherein the dispersion chamber is suitable to provide for independent vortical flow patterns within each of the dual internal dispersion channels.

11. The nebulizer of claim 1, comprising jet nebulization means.

12. The nebulizer of claim 1, comprising linear nebulization means.

13. The nebulizer of claim 1, further comprising a supplementary inhalation channel integral to or in direct communication with the nasal adapter, the channel at one end in communication with ambient air, the other end being positioned adjacent to and in communication with the perimeter of the nasal-proximal aperture of the adapter channel.

16. The nebulizer of claim 1, further comprising a supplementary inhalation channel integral to or in direct communication with the nasal adapter, the channel at one end in communication with ambient air, the other end being annularly positioned at the nasal distal end of the adapter channel to direct supplementary air flow in an annual curtain adjacent to the internal wall of the adapter channel.

17. The nebulizer of claim 1, wherein the substantial mean diameter of the particle size is selected from the group consisting of about 2 to about 50 μ

m, about 5 to about 50 μ

m, about 5 to about 40 μ

m, about 5 to about 35 μ

m, about 5 to about 30 μ

m, about 5 to about 20 μ

m, about 5 to about 17 μ

m, about 5 to about 15 μ

m, about 8 to about 30 μ

m, about 8 to about 25 μ

m, about 8 to about 20 μ

m, about 10 to about 30 μ

m, about 10 to about 25 μ

m, about 10 to about 20 μ

m, about 10 to about 17 μ

m, about 10 to about 15 μ

m, about 11 to about 40 μ

m, about 11 to about 30 μ

m, about 11 to about 20 μ

m, about 11 to about 15 μ

m, about 12 to about 17 μ

m, about 15 to about 25 μ

m, about 15 to about 20 μ

m, and about 17 to about 23 μ

m.

21. The nebulizer of claim 1, further comprising:

an adapter cartridge receiving portion in communication with the nebulizing means;

an adapter cartridge, and a medicament ampoule functionally complementary to the adapter cartridge.

23. The method of claim 23, wherein nebulization is according to claim 21.

24. The method of claim 23, wherein the intended use is of a plurality of particular medicaments, and the user is provided with a corresponding plurality of adapter cartridges.

33. The method of any one of claims 28-33, comprising use of the nebulizer of claim 1.

34. A method of drug delivery to a deep nasal cavity or paranasal sinus, comprising:

producing dispersed nebulized particles using an integrated nebulizer according to claim 1;

and

delivering same to a nasal aperture.

10. The nebulizer of claim 10, wherein the dispersion chamber is suitable to provide for dual vortical flow patterns that spiral in opposite directions.

14. The nebulizer of claim 14, wherein the nasal-proximal end of the inhalation channel is annular, positioned adjacent to and surrounding the perimeter of the nasal-proximal aperture of the adapter channel, and is suitable to provide for a supplementary air curtain substantially adjacent to and surrounding the dispersed flow of delivered nebulized particles.

15. The nebulizer of claim 15, wherein the nebulized particles are delivered in a vortical flow, and wherein, upon supplemental inhalation, the air curtain provides sufficient convective draft to stretch and increase the vorticity of the vortical flow.

18. The nebulizer of claim 18, wherein the substantial mean diameter of the particle size is selected from the group consisting of about 5 to about 30 μ

m, about 8 to about 25 μ

m, about 10 to about 20 μ

m, about 10 to about 17 μ

m, about 10 to about 15 μ

m, and about 12 to about 17 μ

m.

19. The nebulizer of claim 19, wherein the substantial mean diameter of the particle size is selected from the group consisting of about 8 to about 25 μ

m, about 10 to about 15 μ

m, or about 12 to about 15 μ

m.

20. The nebulizer of claim 20, wherein the substantial mean diameter of the particle size is about 8 to about 25 μ

m.

22. A method for providing user-specific nebulized drug delivery using medicament ampoules, comprising:

identifying an intended user of a desired nebulizable medicament;

providing, to the user, a base nebulizer having an adapter cartridge receiving portion, wherein any one of a plurality of adapter cartridge types is receivable by the receiving portion, wherein each adapter cartridge type is designed to be functionally complementary to a corresponding distinctive medicament ampoule design, and wherein each medicament ampoule of a particular distinctive ampoule design comprises a particular nebulizable medicament or dosage thereof assigned to that design; and

providing to the user an adapter cartridge type corresponding to the desired medicament, whereby user-specific nebulized drug delivery is afforded.

25. The method of any one of claims 22 or 23, wherein functionally complementary between the adapter cartridge and the medicament ampoule is based, at least in part, on the external surface or shape of the medicament ampoule.

26. The method of any one of claims 22 or 23, wherein functional complementarity is based on functional design of an otherwise receivable medicament ampoule.

27. A method of drug delivery to a deep nasal cavity or paranasal sinus, comprising:

producing nebulized particles substantially having a uniform mean diameter selected from the group consisting of about 5 to about 30 μ

m, about 8 to about 25 μ

m, about 10 to about 20 μ

m, about 10 to about 17 μ

m, about 10 to about 15 μ

m, and about 12 to about 17 μ

m, wherein; and

passing the nebulized particles, prior to delivery, through a particle dispersion chamber suitable to provide for vortical particle flow.

28. The method of claim 28, wherein the nebulized particles substantially have a uniform mean diameter of about 8 to about 25 μ

m.

29. The method of claim 28, wherein at least 60%, at least 70%, at least 80%, at least 90% or at least 95% of the nebulized particles are of the preferred particle diameter range.

31. The method of claim 28, wherein the particle dispersion chamber comprises dual dispersion channels and provides for dual vortical particle flow patterns targeted to corresponding nostril apertures.

30. The method of claim 30, wherein at least 70%, at least 80%, at least 90% or at least 95% of the nebulized particles are of the preferred particle diameter range.

32. The method of claim 32, wherein the dual vortical particle flow patterns are in opposite directions.