Device and method of delivering particles in the upper respiratory tract

• US 10,391,268 B2
• Filed: 10/31/2017
• Issued: 08/27/2019
• Est. Priority Date: 03/24/2016
• Status: Active Grant

• Current Assignee: Services Médicaux Arnold et Joan Zidulka Inc.
• Original Assignee: Services Médicaux Arnold et Joan Zidulka Inc.
• Inventors: Zidulka, Arnold
• Primary Examiner(s): Stanis, Timothy A
• Application Number:
  US15/798,993
• Publication Number:
  US 20180043112A1
• Time in Patent Office: 665 Days
• CPC Class Codes: A61K 31/58 containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin digitoxin A61K31/7048
• CPC Class Codes: A61K 9/0073 Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy; nasal sprays A61K9/0043; inhalation of vapours of volatile or heated drugs, e.g. essential oils or nicotine, A61K9/007; devices A61M
• CPC Class Codes: A61K 9/0075 for inhalation via a dry powder inhaler [DPI], e.g. comprising micronized drug mixed with lactose carrier particles
• CPC Class Codes: A61K 9/0078 for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
• CPC Class Codes: A61M 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 11/008 by squeezing, e.g. using a flexible bottle or a bulb
• CPC Class Codes: A61M 15/0016 located downstream of the dispenser, i.e. traversed by the product
• CPC Class Codes: A61M 15/002 with air flow regulating means
• CPC Class Codes: A61M 15/0021 Mouthpieces therefor
• CPC Class Codes: A61M 15/0086 Inhalation chambers
• CPC Class Codes: A61M 15/009 using medicine packages with incorporated spraying means, e.g. aerosol cans pocket atomiser of the injector type A61M11/08
• CPC Class Codes: A61M 16/0003 Accessories therefor, e.g. sensors, vibrators, negative pressure
• CPC Class Codes: A61M 16/14 by mixing different fluids, one of them being in a liquid phase
• CPC Class Codes: A61M 2202/064 Powder
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2210/0618 Nose
• CPC Class Codes: A61M 2210/065 Throat; Pharynx
• CPC Class Codes: A61M 2210/1028 Larynx
• CPC Class Codes: A61P 11/02 Nasal agents, e.g. decongestants
• CPC Class Codes: A61P 11/14 Antitussive agents
• CPC Class Codes: A61P 37/08 : Antiallergic agents antiasthmatic agents A61P11/06; ophthalmic antiallergics A61P27/14
• CPC Class Codes: G16H 20/10 : relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/13 : delivered from dispensers
• CPC Class Codes: H04L 63/1416 : Event detection, e.g. attack signature detection
• CPC Class Codes: H04L 63/1425 : Traffic logging, e.g. anomaly detection
• CPC Class Codes: H04L 63/1433 : Vulnerability analysis
• CPC Class Codes: H04L 67/02 : based on web technology, e.g. hypertext transfer protocol [HTTP]

Abstract

A method of delivering a substance in aerosol or powder form to the upper respiratory tract is provided. The substance is orally administered into the larynx, through the pharynx, and out from the nose while minimizing inhalation into the lungs, whereby deposition of particles in the upper respiratory tract is achieved with limited deposition in the trachea, lower airways and lungs. Also provided is an oral delivery device having a mouthpiece for oral inhalation of a flow of a substance into the upper respiratory tract and a flow restrictor for enabling arrestment of the flow minimizing inhalation into the trachea, lower airways and lungs, which provides for a deposition of particles in the upper respiratory tract with limited deposition in the trachea, lower airways and lungs. Also provided is an oral delivery device having a mouthpiece for admission of a flow of a substance into the upper respiratory tract and a flow generator for pressuring the substance into travel through the upper respiratory tract.

Claims

1. An oral delivery device for use by a user for delivering a dose of a substance in aerosol or powder form to the upper respiratory tract of the user, said oral delivery device comprising:

a mouthpiece adapted to be received in the mouth of the user for oral admission of a flow of air into the upper respiratory tract of the user;

a substance inlet for admitting said substance so that said flow of air is configured to carry said substance; and

a delivery regulator comprising a flow restrictor for enabling arrestment of oral inhalation before admission by inhalation into the lungs of the user of said substance, whereby nasal exhalation of said flow of air following said arrestment completes a deposition of particles of said substance in the oral, laryngeal, pharyngeal, and nasal cavities of the user with limited deposition of said particles in the trachea, lower airways and lungs of the user, said flow restrictor comprising a chamber in fluid communication with said mouthpiece having a volume effective to allow said flow of air into said mouth and an air inlet for admitting ambient air at a restricted rate upon said inhalation from said mouthpiece that is configured to cause the user to feel discomfort, arrest inhalation effort and to exhale out from the nose, the size of the air inlet being fixed for a duration of said delivering said dose, and said air inlet being dimensioned so that user inhalation produces a negative pressure in said chamber below −

34 cm of water.

2. The oral delivery device of claim 1, wherein said substance is in aerosol form.

3. The oral delivery device of claim 1, wherein said air inlet is sized to restrict the rate of said inhalation so as to enable a person to whom said dose is delivered to arrest said oral inhalation in a timely manner.

4. The oral delivery device of claim 1, wherein said oral delivery device is adapted for retrofitting on an aerosol or powder medication delivery device.

5. In combination, the oral delivery device of claim 1 and a cartridge containing a corticosteroid and configured to deliver a dose of said corticosteroid, said dose of said corticosteroid is a therapeutically effective dose for the treatment of a medical condition selected from the group consisting of an allergic rhinitis, a non-allergic rhinitis, a rhinosinusitis, and an upper airway cough syndrome.

6. The combination of claim 5, wherein said corticosteroid is ciclesonide.

7. A device for delivering a dose of a substance to the upper respiratory tract of a user, said delivery device comprising:

a mouthpiece;

a substance inlet for admitting said substance; and

a delivery regulator comprising a flow restrictor for enabling arrestment of oral inhalation before admission by inhalation into the lungs of the user of said substance, whereby nasal exhalation of a flow following said arrestment completes a deposition of said substance in the oral, laryngeal, pharyngeal, and nasal cavities of the user with limited deposition of said substance in the trachea, lower airways and lungs of the user, said flow restrictor comprising a chamber in fluid communication with said mouthpiece having a volume effective to allow said flow into said mouth and an air inlet for admitting ambient air at a restricted rate upon said inhalation from said mouthpiece that is configured to cause the user to feel discomfort, arrest inhalation effort and to exhale out from the nose, the size of the air inlet being fixed for a duration of said delivering said dose, and said air inlet being dimensioned so that user inhalation produces a negative pressure in said chamber below −

34 cm of water.