Particle dispersion device for nasal delivery

• US 8,122,881 B2
• Filed: 05/09/2003
• Issued: 02/28/2012
• Est. Priority Date: 05/09/2002
• Status: Expired due to Fees

• Current Assignee: Savine Therapeutics Pty
• Original Assignee: Kurve Technology, Inc.
• Inventors: Giroux, Marc
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): Mendoza, Michael
• Application Number:
  US10/435,401
• Publication Number:
  US 20030217748A1
• Time in Patent Office: 3,217 Days
• Field of Search: 128/203.15, 128/203.17, 128/203.26, 128/203.27, 128/203.28, 128/203.12, 128/207.13, 239/338, 239/505, 239/507, 239/513, 239/514, 239/343, 239/366
• US Class Current: 128/203.15
• CPC Class Codes: A61M 11/00 Sprayers or atomisers specially adapted for therapeutic purposes in general B05B; aerosol containers B65D83/14
• CPC Class Codes: A61M 11/001 Particle size control
• CPC Class Codes: A61M 15/0008 rotating by airflow
• CPC Class Codes: A61M 15/0028 using prepacked dosages, one for each application, e.g. capsules to be perforated or broken-up
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 16/06 Respiratory or anaesthetic masks
• CPC Class Codes: A61M 16/0611 with a gusset portion
• CPC Class Codes: A61M 2206/16 Rotating swirling helical flow, e.g. by tangential inflows
• CPC Class Codes: A61M 2210/0618 Nose

Abstract

A nebulizer and a method of breathing using the nebulizer is described. The nebulizer and breathing techniques are capable of delivering medicament into the sinus cavity of a user.

Claims

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

a nasal adapter having an input and an output;

a particle dispersion chamber having a particle entry end and an output opening and an internal channel between the particle input end and the output opening, the output opening in communication with the nasal adapter input, the particle dispersion chamber having directed fluid outputs within and communicating with the internal channel and configured to direct output forward to impart a vortical flow to aerosolized particles exiting the dispersion chamber output opening and entering the nasal adapter, and wherein the internal channel has a substantially continuous cross-sectional area from the particle input end of the housing and including a location of a fluid output within the internal channel to, and including, the output opening;

a nebulizing or aerosolizing chamber in direct communication with the particle dispersion chamber, and in which a medicine is nebulizable or aerosolizable; and

a nebulizing or aerosolizing pressure feed in communication with the nebulizing or aerosolizing chamber, and having a compressor channel to channel compressed fluid.

2. The particle dispersion device for nasal delivery of claim 1, further comprising a nebulizing or aerosolizing pressure release member comprising a pressure release channel having at a first end a pressure release orifice, and at a second end is in communication with the compressor channel of the nebulizing or aerosolizing pressure feed to channel compressed fluid through the pressure release member and orifice and into the nebulizing or aerosolizing chamber, and wherein the pressure release member and pressure release channel extend into the nebulizing or aerosolizing chamber.

3. The particle dispersion device for nasal delivery of claim 2, wherein the pressure release member is integral with the nebulizing or aerosolizing pressure feed.

4. The particle dispersion device for nasal delivery of claim 2, wherein the pressure release member is integral with the nebulizing or aerosolizing chamber, or integral with a substantial portion of the nebulizer or aerosolizing chamber.

5. The particle dispersion device for nasal delivery of claim 2, wherein the pressure release member is integral with both the nebulizing or aerosolizing pressure feed, and the nebulizing or aerosolizing chamber or a substantial portion thereof.

6. The particle dispersion device for nasal delivery of claim 2, wherein the pressure release member is conoid or substantially conical in shape, tapering to a vertex within the nebulizing chamber, and wherein the pressure release orifice is positioned at the vertex or substantially at the vertex.

7. The particle dispersion device for nasal delivery of claim 1, wherein the wall of particle dispersion chamber comprises at least one integral dispersion feed channel suitable to channel compressed fluid into the dispersion chamber to create a vortex, or otherwise affect movement of nebulized particles.

8. The particle dispersion device for nasal delivery of any one of claims 1 and 2, wherein the fluid is air or another suitable compressible gas.

9. The particle dispersion device for nasal delivery of claim 1, wherein the nebulized or aerosolized particles delivered to the nasal adaptor are from about 15 to about 35 microns in diameter.

10. The particle dispersion device for nasal delivery of claim 1, wherein nebulized or aerosolized particles delivered to the nasal adaptor are from about 20 to about 30 microns in diameter.

11. The particle dispersion device for nasal delivery of claim 1, wherein nebulized or aerosolized particles delivered to the nasal adaptor are from about 2 to about 50 microns in diameter.

12. The particle dispersion device for nasal delivery of claim 1, wherein nebulized or aerosolized particles delivered to the nasal adaptor are of a size to facilitate systemic delivery thereof.

13. The particle dispersion device for nasal delivery of claim 1, wherein the nasal adapter has a lip.

14. The particle dispersion device for nasal delivery of claim 13, wherein the lip is about ⅛

inch long and suitable for forming a seal.

15. The particle dispersion device for nasal delivery of claim 1, wherein the nasal adapter has a width of about 1½

inches across a bridge of the nasal adapter and a length of about 1½

inches.

16. The particle dispersion device for nasal delivery of claim 1, wherein the nasal adapter has a plurality of exhaust vents.

17. The particle dispersion device for nasal delivery of claim 1, further comprising a band, the band connected to the nasal adapter, wherein the band is suitable to secure the nasal adapter to the face of a user.

18. The particle dispersion device for nasal delivery of claim 1, further comprising a hose, the hose in communication with the particle dispersion chamber.

19. The particle dispersion device for nasal delivery of claim 18, wherein the hose is an accordion hose.

20. The particle dispersion device for nasal delivery of claim 1, further comprising a shut-off timer.

21. The particle dispersion device for nasal delivery of claim 1, further comprising a pause feature.

22. The particle dispersion device for nasal delivery of claim 1, wherein the nebulizing or aerosolizing chamber comprises a multi-dose compartment.

23. The particle dispersion device for nasal delivery of claim 1, further comprising a medicament cartridge or ampule, having a three-dimensional exterior surface shape and an interior cavity suitable for housing a medicament, wherein the cartridge or ampule is insertible into a complementary receptacle of the nebulizing or aerosolizing chamber and is thereby cooperative with the particle dispersion device to enable dispensing of medicament into the nebulizing or aerosolizing chamber.

24. The particle dispersion device for nasal delivery of claim 23, wherein the medicament cartridge or ampule is substantially comprised of a biodegradable plastic.

25. A method for topical drug delivery to, or systemic drug delivery via, a deep nasal cavity or paranasal sinus, comprising:

providing the particle dispersion device for nasal delivery of claim 1; and

breathing medicament-containing particles therefrom through a nasal cavity, wherein topical drug delivery to, or systemic drug delivery via, a deep nasal cavity or paranasal sinus is afforded.

26. The method of claim 25, wherein the medicament is for treatment or partial treatment of a condition selected from the group consisting of sinusitis, allergies, rhinitis, migraine headache, influenza, the common cold, and combinations thereof.

27. The method of claim 25, wherein the medicament is delivered, at least in part, systemically via a deep nasal cavity or paranasal sinus.

28. The method of claim 25, wherein the medicament comprises an agent selected from the group consisting of synthetic and natural peptides, proteins, antibodies, hormones, vaccines, DNA and RNA, sugars, carbohydrates, lipids, small synthetic organic pharmaceuticals, radiopharmaceuticals, vitamins, homeopathic solutions, any suitably aerosolizable pharmaceutical, and combinations thereof, with or without additional formulation to enhance stability or crossing of the mucosal membrane by the agent.