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

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,

1 . A gas package device for supplying one or more therapeutic gases, comprising:
 a reservoir that is capable of supplying the therapeutic gases;   an interface layer, made of a gas permeable material surrounding the reservoir, that regulates the flow of the therapeutic gases from the reservoir to an environment external to the device; and   an element, covering all or some of the interface layer, that prevents the flow of therapeutic gases to the external environment until the 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.   
     
     
         2 . The gas package device of  claim 1 , wherein the therapeutic gases are selected from the group consisting of gaseous nitric oxide (gNO), oxygen (O 2 ), carbon monoxide (CO), nitrogen (N 2 ), and nitrous oxide (N 2 ). 
     
     
         3 . The gas package device of  claim 2 , wherein the therapeutic gas is gaseous nitric oxide (gNO). 
     
     
         4 . The gas package device of  claim 3 , wherein the device is capable of administering the gaseous nitric oxide (gNO) in dosages up to about 50,000 ppm. 
     
     
         5 . The gas package device of  claim 3 , wherein the device is capable of administering the gaseous nitric oxide (gNO) in substantially pure dosages. 
     
     
         6 . The gas package device of  claim 2 , wherein the therapeutic gas is nitrous oxide (N 2 O) and the device is capable of alleviating or managing pain. 
     
     
         7 . The gas package device of  claim 1 , further comprising an adhesive that is capable of securing the device to an animal or human patient, 
     
     
         8 . The gas package device of  claim 1 , further comprising a wrap that is capable of securing the device to an animal or human patient. 
     
     
         9 . The gas package device of  claim 1 , wherein the device is configured as a fitted garment for application to an appendage or limb of an animal or human patient. 
     
     
         10 . The gas package device of  claim 1 , wherein the device is configured as a wrap so the device is capable of being fitted over irregular shapes, 
     
     
         11 . The gas package device of  claim 1 , wherein the device is configured as a suppository for insertion into the orifices of animal or human bodies. 
     
     
         12 . The gas package device of  claim 1 , wherein the device is housed within a shroud that is capable of enclosing at least a portion of an animal or human patient. 
     
     
         13 . The gas package device of  claim 1 , wherein the device is configured to be inserted into a gas conditioning cartridge used with breathing apparatuses and protective suits. 
     
     
         14 . The gas package device of  claim 1 , wherein the device is incorporated into a gas mask. 
     
     
         15 . The gas package device of  claim 1 , wherein the device is configured as a sterile bandage or wound cover, and the sterile bandage or wound cover is capable of returning to a sterile state if contaminated upon application or use. 
     
     
         16 . The gas package device of  claim 1 , wherein the device is configured as a flow-through element for treating fluids. 
     
     
         17 . The gas package device of  claim 16 , wherein the fluid to be treated is air. 
     
     
         18 . The gas package device of  claim 16 , wherein the fluid to be treated is blood. 
     
     
         19 . The gas package device of  claim 1 , wherein the device is installed in a ventilator circuit. 
     
     
         20 . The gas package device of  claim 1 , wherein the device is configured as part of a durable airtight bag and the device is capable of substantially sterilizing the contents of the bag after activation. 
     
     
         21 . The gas package device of  claim 1 , wherein the device is configured as a wound dressing for application to the situs of a wound and is capable of maintaining or creating a sterile field at the wound situs. 
     
     
         22 . The gas package device of  claim 1 , wherein the interface layers are selected from the group consisting of polymeric materials, densely woven fabrics or mesh, porous solid materials, and thin membrane materials that are capable of passing therapeutic gas by diffusion or another permeating mechanism. 
     
     
         23 . The gas package device of  claim 1 , wherein the reservoir supplies one or more therapeutic gases by the reaction of chemical reagents, and wherein the reaction is initiated by a stimulus selected from the group consisting of electric current and thermal energy. 
     
     
         24 . The gas package device of  claim 1 , wherein the reservoir supplies one or more therapeutic gases by compromising one or more glass ampoules contained within the reservoir. 
     
     
         25 . The gas package device of  claim 1 , further comprising a sealing layer housed within the confines of the interface layer, wherein the sealing layer defines at least some portion of the reservoir. 
     
     
         26 . The gas package device of  claim 1 , wherein the reservoir and interface layer are divided into multiple cells and the cells can be individually activated. 
     
     
         27 . A gas patch for supplying one or more therapeutic gases, comprising:
 an internally pressurized gas-containing reservoir that is capable of supplying the therapeutic gases; and   an interface layer, made of a gas permeable material surrounding the reservoir, that regulates the flow of the therapeutic gases from the reservoir to an environment external to the patch, wherein the interface layer is provided with structural tension members that are capable of maintaining a shape and geometry of the gas patch.   
     
     
         28 . The gas patch of  claim 27 , wherein the geometry of the gas patch is selected from the group consisting of a thin, planar geometry and a cylindrical geometry. 
     
     
         29 . The gas patch of  claim 27 , wherein the structural tension members are selected from the group consisting of ribs, flanges, internal wires, and quilt stitching. 
     
     
         30 . A tension-type bandage for placement over a wound and administration of one or more therapeutic gases to the wound, comprising:
 a reservoir that is capable of supplying the therapeutic gases;   an interface layer, made of a gas permeable material surrounding the reservoir, that regulates the flow of the therapeutic gases from the reservoir to the wound; and   an element, covering all or some of the interface layer, that prevents the flow of therapeutic gases to the wound until the 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,   
       wherein the reservoir, interface layer, and element are incorporated into the body of a tension-type bandage.