Low flow rate nasal treatment delivery device for mixed carbon dioxide and saline

• US 10,052,464 B2
• Filed: 04/22/2016
• Issued: 08/21/2018
• Est. Priority Date: 06/04/2012
• Status: Active Grant

• Current Assignee: Clover Hill Healthcare, Inc.
• Original Assignee: Clover Hill Healthcare, Inc.
• Inventors: Glynn, Kenneth P
• Primary Examiner(s): Gilbert, Andrew
• Assistant Examiner(s): Ponton, James D
• Application Number:
  US14/999,292
• Publication Number:
  US 20160325080A1
• Time in Patent Office: 851 Days
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 33/14 Alkali metal chlorides; Alkaline earth metal chlorides
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61K 9/0043 Nose
• 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 11/007 Syringe-type or piston-type sprayers or atomisers
• CPC Class Codes: A61M 11/02 operated by air or other gas pressure applied to the liquid or other product to be sprayed or atomised sprayers for horticulture A01G, A01H; killing insects A01M; air humidifying by nozzles F24F6/14, F24F6/18; cooling by spraying F28B, F28C
• CPC Class Codes: A61M 15/08 Inhaling devices inserted into the nose
• CPC Class Codes: A61M 2202/0007 introduced into the body
• CPC Class Codes: A61M 2202/0225 Carbon oxides, e.g. Carbon dioxide
• CPC Class Codes: A61M 2202/0468 non-physiological
• CPC Class Codes: A61M 2205/3334 Measuring or controlling the flow rate
• CPC Class Codes: A61M 3/005 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 31/00 Devices for introducing or retaining media, e.g. remedies, in cavities of the body A61M25/00 takes precedence ; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008
• CPC Class Codes: A61M 39/24 Check- or non-return valves

Abstract

A method of treatment and a nasal delivery device for dosages containing dissolved gaseous carbon dioxide in saline fluid for treating head ailments includes: a) a main housing having a hollow central area containing the dosage; b) a dosage dispenser head located at the distal end of the main housing, having at least one flow channel for movement of the dosage from the main housing through the dosage dispenser head and externally of the dosage dispenser head; c) a dosage release control component located between the main housing and the dosage dispenser head to permit flow of the dosage through the dosage dispenser head in response to increased pressure against the dosage at a flow rate of less than 1 cc per second; and d) a pressure-changing moveable component located on the main housing.

Claims

1. A releasable nasal treatment delivery device for mixed carbon dioxide and saline for treating head ailments in a patient in need thereof, comprising:

a) a main housing having a proximal and a distal end and having a hollow central area containing a releasable nasal treatment dosage that includes a saline fluid and gaseous carbon dioxide, wherein said gaseous carbon dioxide is dissolved in said saline fluid;

b) a dosage dispenser head located at said distal end of said main housing, said dosage dispenser head having at least one flow channel for movement of said dosage from said main housing through said dosage dispenser head and externally of said dosage dispenser head;

c) a dosage release control component located between said main housing and said dosage dispenser head adapted to permit flow of the dosage comprising said saline fluid and said gaseous carbon dioxide from said main housing and through said dosage dispenser head in response to increased pressure against said dosage release control component wherein said permitted flow has controlled release at a flow rate of less than 1 cubic centimeter per second and wherein said flow rate is a total flow rate of said dosage;

d) a pressure-changing moveable component located on said main housing;

wherein, when said dosage dispenser head of said device is placed in a nasal cavity and said pressure-changing moveable component is activated by movement toward said dosage, said dosage is at least partially forced through said dosage release control component at the permitted flow rate and through said dosage dispenser head for application of said dosage to a nasal cavity wall.

2. The releasable nasal treatment delivery device of claim 1, wherein said dosage release control component is selected from the group consisting of a frangible member, a puncturable member and a one-way valve.

3. The releasable nasal treatment delivery device of claim 1, which further comprises:

a nose guard flange connected to and extending from at least one of said main housing and said dosage dispenser head.

4. The releasable nasal treatment delivery device of claim 1, wherein said main housing is an open ended tube with said dosage release control component and said dosage dispenser head located at said distal end of said main housing and said pressure-changing moveable component is located at said proximal end of said main housing.

5. The releasable nasal treatment delivery device of claim 4, wherein said pressure-changing moveable component is a flexible squeeze member and a seal float.

6. The releasable nasal treatment delivery device of claim 4, wherein said pressure-changing moveable component is a push-up piston.

7. The releasable nasal treatment delivery device of claim 4, wherein at least a portion of said tube is flexible and constitutes said pressure-changing moveable component.

8. The releasable nasal treatment delivery device of claim 1, wherein said flow rate is greater than 0.01 and less than 1 cubic centimeter per second.

9. The releasable nasal treatment delivery device of claim 1, wherein said flow rate is greater than 0.08 and less than 1 cubic centimeter per second.

10. The releasable nasal treatment delivery device of claim 1, wherein said flow rate is greater than 0.1 and less than 1 cubic centimeter per second.

11. A method of treating head ailments in a patient in need thereof utilizing a nasal treatment delivery device containing dissolved carbon dioxide and saline fluid, which comprises:

a) providing the releasable nasal treatment delivery device of claim 1; and

,

b) directing at least a portion of the nasal treatment dosage of the device of claim 1 to at least one nasal cavity of said patient through said dosage dispenser head.

12. The method of claim 11 wherein said dosage release control component of the releasable nasal treatment delivery device of claim 1 is set to deliver a flow rate greater than 0.01 and less than 1 cubic centimeter per second.

13. The method of claim 11, wherein said dosage release control component of the releasable nasal treatment delivery device of claim 1 is set to deliver a flow rate greater than 0.08 and less than 1 cubic centimeter per second.

14. The method of claim 11, wherein said dosage release control component of the releasable nasal treatment delivery device of claim 1 is set to deliver a flow rate greater than 0.1 and less than 1 cubic centimeter per second.