Methods and devices for the delivery of therapeutic gases including nitric oxide

• US 8,079,998 B2
• Filed: 03/02/2007
• Issued: 12/20/2011
• Est. Priority Date: 10/20/2006
• Status: Active Grant

• Current Assignee: Beyond Air Ltd. (Beyond Air, Inc.)
• Original Assignee: Pulmonox Technologies Corp.
• Inventors: Hole, Douglas R., Figley, Curtis, Lee, Robert E., Hudec, Michael, Rolfson, Robert
• Primary Examiner(s): Mehta, Bhisma
• Application Number:
  US11/713,344
• Publication Number:
  US 20080097282A1
• Time in Patent Office: 1,754 Days
• Field of Search: 604/23, 604/24, 604/26, 604/500, 604/503, 604/505
• US Class Current: 604/500
• CPC Class Codes: A61F 13/0226 characterised by the support layer
• CPC Class Codes: A61F 13/05 specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
• CPC Class Codes: A61F 13/8405 Additives, e.g. for odour, disinfectant or pH control
• CPC Class Codes: A61F 2013/00646 Medication patches, e.g. transcutaneous
• CPC Class Codes: A61F 2013/0091 with disinfecting or anaesthetics means, e.g. anti-mycrobic
• CPC Class Codes: A61J 3/08 into the form of suppositories or sticks
• CPC Class Codes: A61K 33/00 Medicinal preparations containing inorganic active ingredients
• CPC Class Codes: A61K 9/7007 Drug-containing films, membranes or sheets A61K9/0041, A61K9/0043, A61K9/006, A61K9/0063 take precedence
• CPC Class Codes: A61L 15/44 Medicaments
• CPC Class Codes: A61L 2/0094 Gaseous substances
• CPC Class Codes: A61L 2300/114 Nitric oxide, i.e. NO
• CPC Class Codes: A61L 2300/60 characterised by a special physical form
• CPC Class Codes: A61M 16/1055 bacterial
• CPC Class Codes: A61M 16/106 in a path
• CPC Class Codes: A61M 16/12 by mixing different gases
• CPC Class Codes: A61M 16/208 Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
• CPC Class Codes: A61M 2202/0275 Nitric oxide [NO]

Abstract

Gas packages for the delivery of therapeutic gases, and in particular gaseous nitric oxide (gNO) are provided herein. The gas packages comprise one or more of a gas reservoir, interface layer, sealing layer, and holding container. The interface layer regulates discharge of the therapeutic gas from the gas reservoir to the external environment. The sealing layer and/or holding container prevent evolution of the gas until the sealing layer is compromised or the holding container is opened. The gas packages and methods for using them are useful for the treatment, alleviation, and prevention of various disease and non-disease, medical and non-medical, conditions in humans and animals.

Claims

1. A method of administering one or more therapeutic gases to an animal or human patient, comprising:

providing at least one device comprising a reservoir that is capable of supplying the one or more therapeutic gases, an interface layer, made of a gas permeable material surrounding the reservoir, through which the gases must transit in order to reach the patient,

and an element, covering all or some of the interface layer, that prevents the flow of therapeutic gases through the interface layer to the patient until the at least one device is activated, and that is selected from the group consisting of a sealing layer, a holding container, and combinations thereof;

activating the at least one device by compromising the element; and

allowing the one or more therapeutic gases to transit from the reservoir through the interface layer to the patient.

2. The method of claim 1, wherein the one or more therapeutic gases are selected from the group consisting of gaseous nitric oxide (gNO), oxygen (O₂), carbon monoxide (CO), nitrogen (N₂), and nitrous oxide (N₂O).

3. The method of claim 2, wherein the one or more therapeutic gases is gaseous nitric oxide (gNO).

4. The method of claim 1, further comprising selecting the interface layer on the basis of one or more factors selected from the group consisting of the partial pressure of therapeutic gases in the reservoir, the concentration of the one or more therapeutic gases in the reservoir, and a desired delivery rate of the one or more therapeutic gases to the animal or human patient.

5. The method of claim 1, wherein the one or more therapeutic gases are administered to a situs on or in the animal or human patient selected from the group consisting of the mouth, teeth, gums, anus, vagina, nose, ears, eyes, and skin.

6. The method of claim 1, wherein the one or more therapeutic gases are administered into a protective suit and subsequently inhaled by the animal or human patient.

7. The method of claim 1, wherein the one or more therapeutic gases are administered into a protective suit and subsequently absorbed into the animal or human patient'"'"'s skin.

8. The method of claim 1, wherein the one or more therapeutic gases are administered into a breathing apparatus and subsequently inhaled by the animal or human patient.

9. The method of claim 1, wherein the one or more therapeutic gases treat a disease or non-disease state in the animal or human patient selected from the group consisting of:

vasodilatation;

bacterial, viral, and fungal infections;

biofilms;

respiratory conditions;

respiratory, airway, eye, and ear infections;

wound infections;

burns;

cancer;

cosmetic conditions;

topical conditions;

skin and tissue conditions;

blood conditions;

inflamation;

bronchoconstriction;

reversible pulmonary vasoconstriction;

asthma;

pulmonary hypertension;

adult respiratory distress syndrome (ARDS); and

persistent pulmonary hypertension of the newborn (PPHN).

10. The method of claim 1, wherein the one or more therapeutic gases prevent a disease or non-disease state in the animal or human patient selected from the group consisting of vasodilatation;

bacterial, viral, and fungal infections;

biofilms;

respiratory conditions;

respiratory, airway, eye, and ear infections;

wound infections;

burns;

cancer;

cosmetic conditions;

topical conditions;

skin and tissue conditions;

blood conditions;

inflamation;

bronchoconstriction;

reversible pulmonary vasoconstriction;

asthma;

pulmonary hypertension;

adult respiratory distress syndrome (ARDS); and

persistent pulmonary hypertension of the newborn (PPHN).

11. A method of treating or preventing disease and non-disease states in an animal or human patient, comprising administering one or more therapeutic gases to the patient by activating one or more gas package devices, wherein at least one gas package device comprises:

a reservoir that is capable of supplying the one or more therapeutic gases;

an interface layer, made of a gas permeable material surrounding the reservoir, that regulates the flow of the one or more therapeutic gases from the reservoir to an environment external to the at least one device; and

an element, covering all or some of the interface layer, that prevents the flow of therapeutic gases through the interface layer to the external environment until the at least one device is activated by compromising the element, and that is selected from the group consisting of a sealing layer, a holding container, and combinations thereof.

12. The method of claim 11, wherein the disease and non-disease states are selected from the group consisting of:

vasodilatation;

bacterial, viral, and fungal infections;

biofilms;

respiratory conditions;

respiratory, airway, eye, and ear infections;

wound infections;

burns;

cancer;

cosmetic conditions;

topical conditions;

skin and tissue conditions;

blood conditions;

inflammation;

bronchoconstriction;

reversible pulmonary vasoconstriction;

asthma;

pulmonary hypertension;

adult respiratory distress syndrome (ARDS); and

persistent pulmonary hypertension of the newborn (PPHN).

13. The method of claim 11, wherein the one or more therapeutic gases are selected from the group consisting of gaseous nitric oxide (gNO), oxygen (O₂), carbon monoxide (CO), nitrogen (N₂), and nitrous oxide (N₂O).

14. The method of claim 13, wherein the one or more therapeutic gases is gaseous nitric oxide (gNO).

15. The method of claim 11, wherein the one or more therapeutic gases is delivered to a situs on or in the animal or human patient selected from the group consisting of the skin, respiratory airways, upper nasal system, sinuses, eyes, rectum, vagina, face, and mouth.