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Nasal Nebulizer Nasaler Vernebler Nebuliseur Nasal

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Nasal Nebulizer Nasaler Vernebler Nebuliseur Nasal (19) TZZ_Z_T (11) EP 1 450 885 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: A61M 15/08 (2006.01) A61M 11/00 (2006.01) 22.04.2015 Bulletin 2015/17 A61M 15/00 (2006.01) A61M 16/06 (2006.01) (21) Application number: 02778422.2 (86) International application number: PCT/US2002/031450 (22) Date of filing: 30.09.2002 (87) International publication number: WO 2003/026559 (03.04.2003 Gazette 2003/14) (54) NASAL NEBULIZER NASALER VERNEBLER NEBULISEUR NASAL (84) Designated Contracting States: (56) References cited: AT BE BG CH CY CZ DE DK EE ES FI FR GB GR EP-A- 0 539 674 EP-A- 0 734 719 IE IT LI LU MC NL PT SE SK TR EP-A- 0 747 078 WO-A-01/36033 WO-A-01/49350 WO-A-98/26827 (30) Priority: 28.09.2001 US 325971 P WO-A-99/47273 GB-A- 1 069 048 09.05.2002 US 379428 P US-A- 3 362 405 US-A- 4 299 784 US-A- 4 454 880 US-A- 4 461 425 (43) Date of publication of application: US-A- 4 809 692 US-A- 5 203 323 01.09.2004 Bulletin 2004/36 US-A- 5 309 900 US-A- 5 435 282 US-A- 5 458 135 US-A- 5 485 828 (73) Proprietor: Kurve Technology, Inc. US-A- 5 577 497 US-A- 5 755 218 Lynnwood, WA 98036 (US) US-A- 5 785 049 US-A- 5 855 202 US-A- 5 950 623 US-A- 6 112 746 (72) Inventor: GIROUX, Marc US-B1- 6 202 643 US-B1- 6 240 917 Lynnwood, WA 98036 (US) (74) Representative: EP&C P.O. Box 3241 2280 GE Rijswijk (NL) Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 1 450 885 B1 Printed by Jouve, 75001 PARIS (FR) 1 EP 1 450 885 B1 2 Description [0007] WO-A-99/47273 discloses a medication processing system and method, wherein a vortex cham- BACKGROUND ber is provided, which enables a turbulent flow and which substantially eliminates the formation of liquid orbital [0001] This invention relates to devices for administra- 5 rings on the inner walls put in the vortex chamber. tion of therapeutic agents to the nasal cavity and para- [0008] WO-A-98/26827 discloses a powder inhaler, in nasal sinuses of a patient. which a circulatory section and a cyclone chamber are [0002] In the United States, sixty million people suffer provided for effecting separation of the heavier particles from chronic sinusitis and allergic rhinitis and are treated from lighter particles. The circulating flow is arranged so by means of antihistamines, antibiotics, decongestants, 10 that the air/powder mixture enters the cyclone chamber and pain relievers. Many of these drugs would work more at relatively high speed. effectively in relieving symptoms if they could be directly applied to all of the affected areas. However, the devices SUMMARY OF THE INVENTION utilized thus far to deliver these drugs have proven to be extremely inadequate, if not useless, in reaching all areas 15 [0009] The invention provides a particle dispersion needed especially the deep nasal cavity and paranasal chamber comprising a housing having an external sur- sinuses where it is critical in the treatment of some of face and an internal channel having a user output open- these diseases. There is a need for a more effective de- ing, and a plurality of directional air outputs positioned vice to administer these medicines to all the areas of the along and communicating with the internal channel, the nasal cavity and paranasal sinuses. 20 direction of the air outputs suitable to create a vortical [0003] A current delivery system consists of a pressu- flow of aerosolized particles within the internal channel, rized canister (MDI) that ejects the medicine into the nos- and is characterized in that said internal channel of the trils in short bursts, or streams of atomized liquid in an particle dispersion chamber is configured as vortex con- aqueous nasal spray. The efficacy of medicine adminis- tinuing channel to provide for continuation of the vortical tered in this manner is limited due to difficulties in the 25 flow from the air outputs to and including the user output medicine reaching very little of the nasal mucosa and no openingsuch thatsaid aerosolized particles emerge from part of paranasal sinuses where it needs to be delivered said particle dispersion chamber in said vortex move- to fully treat the condition. In cases of severe congestion ment. or nasal polyps, the medicine often does not proceed beyond the nostril and will not be effectively absorbed 30 BRIEF DESCRIPTION OF THE DRAWINGS into the bloodstream or the necessary area of the nasal cavity and paranasal sinuses. Current systems also do [0010] The foregoing aspects and many of the attend- not allow particle sizes to be small enough to reach high ant advantages will become more readily appreciated as into the nasal cavity and paranasal sinuses. There is a the same become better understood by reference to the need for delivery system alternatives to better deliver 35 following detailed description, when taken in conjunction more of the medicine to the nasal cavity and paranasal with the accompanying drawings, wherein: sinuses and of the sufferers of these diseases, and oth- ers. FIGURE 1 is a top planar view of one embodiment [0004] A nebulizer is, for example, a machine that con- of the nasal nebulizer; verts medicine into a mist, or vapor, of very tiny particles 40 to deliver a drug to the lungs during an attack by breathing FIGURE 2 is a frontal elevational view of the nasal the medicine from a pipe attachment or, in the case of nebulizer; young children, a face mask. The particle size is impor- tant in that it allows passage of the drug through heavily FIGURE 3 is a side elevational view of the nasal congested airways over a period of about 10 minutes 45 nebulizer; which allows for deep penetration. Nebulizers are used by asthmatics in case of an asthma attack. FIGURE 4 is a bottom planar view of the nasal neb- [0005] Nasal nebulizers are currently in use for antibi- ulizer; otics and are ineffectively delivered due to the fact they do not deliver into the paranasal sinuses nor as far into 50 FIGURE 5 is a side cross-sectional view of the nasal the nasal cavity as this device due to the lack of additional nebulizer of Fig. 1 along line A-A showing internal technology enclosed herein. components thereof; [0006] WO-A-01/36033 discloses an internal vortex mechanism for an inhaler device. The vortex mechanism FIGURE 6 is a front view of one embodiment of the is provided to obtain a circumferential-swirling turbulent 55 nasal adapter; boundary layer flow along the inner surface of a chamber in order to limit impaction and sticking of medication to FIGURE 7 is a rear view of the nasal adapter; the inner surface of the chamber. 2 3 EP 1 450 885 B1 4 FIGURE 8 is a side view of the tubing and nasal DETAILED DESCRIPTION OF THE PREFERRED EM- adapter; BODIMENT FIGURE 9 is a side view of another embodiment of [0011] Current drug delivery methods are ineffective the nebulizer showing the cartridge chamber; 5 at penetrating very far into the nasal cavity and not at all into the paranasal sinuses. The nebulizer 25 has the abil- FIGURE 10 is a top view of the nebulizer showing ity to deliver the same drugs presently prescribed for dis- the cartridge chamber; eases as very tiny particle doses of medicine via a nasal adapter 10 that allows more efficacious sinus penetration FIGURE 11 shows one embodiment of the particle 10 for the user. The particle sizes, time of application and dispersion chamber, the tubing, and the nasal adapt- particle dispersion technology allows the medicine to per- er; meate the nasal cavity and most of the paranasal sinus- es. All medicines currently applied by direct action to the FIGURE 12 shows a further embodiment of the nasal nasal cavity and paranasal sinuses could be adapted for adapter, particle dispersion chamber, and tubing; 15 use with the nebulizer 25, and that would include over- the-counter nasal medicines for allergy and colds and flu. FIGURE 13 shows yet another embodiment of the [0012] For the user with the secondary condition of na- nasal adapter, particle dispersion chamber, and tub- sal polyps, this allows far more effective application of ing; the medicine, which is often blocked by the polyp from 20 penetrating even as much as the contemporary systems FIGURE 14a shows another embodiment of the na- can. Corticosteroid-based inhalers are designed to also sal adapter, particle dispersion chamber, and tubing; slow the re-growth of these polyps following their remov- al. Currently, they are largely ineffective at accomplishing FIGURE 14b shows a bottom view of one embodi- this, often not being able to slow the growth at all. The ment of the baffle; 25 apparatus and method described herein will be signifi- cantly more effective in slowing the re-growth of the pol- FIGURE 15 shows yet another embodiment of a na- yps following their removal.
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