Abstract: A dry powder nicotine formulation suitable for inhalation is described. The formulation includes nicotine particles, wherein the nicotine particles are substantially in the range of about 1-10 micron in size, preferably 2-5 micron in size. The formulation may also include a cough suppressant component having particles in the 5-100 micron size range. The formulation may also include a cough suppressant component having particles in the 10-200 micron size range. The formulation may also include a flavor component having particles in the 10-1000 micron size range.

Abstract: The present invention is directed to a Continuous Positive Airway Pressure Device as an apparatus configured to provide positive airway pressure in a respiratory circuit that comprises a container configured to be filled to a preselected level with liquids; a drop tube assembly comprising a hollow gas tube rotatably mounted in said container having an upper end extending a static distance outwardly of the container and connected to a respiratory circuit downstream of a user, and a hollow drop tube reciprocally movable upwardly and downwardly in the liquid in response to rotational movement of the gas tube. The container is provided with a gas vent and a liquid fill port.

Abstract: A method and corresponding device are described for combating microbes and infections by delivering intermittent high doses of nitric oxide to a mammal for a period of time and which cycles between high and low concentration of nitric oxide gas. The high concentration of nitric oxide is preferably delivered intermittently for brief periods of time that are interspersed with periods of time with either no nitric oxide delivery or lower concentrations of nitric oxide. The method is advantageous because at higher concentration, nitric oxide gas overwhelms the defense mechanism of pathogens that use the mammalian body to replenish their thiol defense system. A lower dose or concentration of nitric oxide gas delivered in between the bursts of high concentration nitric oxide maintains nitrosative stress pressure on the pathogens and also reduces the risk of toxicity of nitric oxide gas.

Abstract: A gas flow regulating device including a housing assembly, an inlet tube assembly, and a biasing device. The housing assembly has a main housing, a valve seat body, and a distal plate forming an outlet orifice. The inlet tube assembly includes a proximal inlet end, a tube forming a lumen, and a flange, and is slidably disposed within the main housing, biased to an open state by the biasing device. The flange separates middle and constant pressure chambers within the housing assembly. The inlet tube assembly is transitionable to a closed state in response to pressure in the constant pressure chamber to generate a relatively constant flow rate of air exiting the device via the outlet orifice.

Abstract: A device for reducing the concentration of a gas from a gas source is described. The device includes a housing having a proximal end, a distal end and a length therebetween that at least partially encloses an interior region, wherein the proximal end has a gas inlet connectable to a gas source, and the distal end has a diluted gas outlet, a nozzle having at least one gas outlet, wherein the nozzle extends within the interior region of the housing, and wherein the nozzle gas outlet is fluidly connected to the housing gas inlet such that gas entering the housing gas inlet exits through the nozzle gas outlet, and at least one opening in the housing length, wherein the opening is adjacent to the at least one nozzle gas outlet and permits air to enter the housing interior region near the nozzle gas outlet. The device is incorporated into a gas delivery assembly, whereby excess gas can be safely purged from the assembly at a diluted concentration via the device.

Abstract: The present invention relates to a system and method of treating a subject with nitric oxide gas and/or nitric oxide releasing solutions. The present invention also relates to compositions and devices useful for treating a subject with nitric oxide gas and/or nitric oxide releasing solutions.

Abstract: The present invention relates to devices, systems, and methods for a safety interlock for a gas cylinder. The interlock device of the present invention can prevent a gas cylinder from being removed from a gas administration device as long as gas remains in the gas cylinder.

Abstract: An adapter assembly including a manifold and a valve assembly. The valve assembly includes a seat and a valve body having a circular base and a wall. The wall extends from a trailing side of the base to form a dome-like shape terminating at an end at which a slit is formed, with the wall defining opposing sealing edges at the slit. The seat has an upper circumferential surface and a lower circumferential surface. The upper surface engages a leading side of the base, whereas the lower surface engages a trailing side. At least one of the upper and lower surfaces forms a segment of increased height. Upon final assembly, the valve body is disposed across a passageway of the manifold, with the slit providing a selectively openable path. A force imparted by the segment of increased height flexes the base and biases the sealing edges into engagement.

Abstract: A system for keeping moisture in a vapor phase and for removing particles from a gas is described. The system includes a filter and a heating chamber. The filter is capable of being heated and includes a mechanical element that effectively regulates the heating of the filter. Heat production of the heating chamber is coupled to the proper insertion of the filter into the chamber, such that the filter closes an electrical switch in the heating chamber to allow for the production of heat. An exemplary use of the system is the keeping moisture in a vapor phase and removing pathogenic particles from the exhalation path of a ventilated subject.

Abstract: A gas flow regulating device including a housing assembly, an inlet tube assembly, and a biasing device. The housing assembly has a main housing, a valve seat body, and a distal plate forming an outlet orifice. The inlet tube assembly includes a proximal inlet end, a tube forming a lumen, and a flange, and is slidably disposed within the main housing, biased to an open state by the biasing device. The flange separates middle and constant pressure chambers within the housing assembly. The inlet tube assembly is transitionable to a closed state in response to pressure in the constant pressure chamber to generate a relatively constant flow rate of air exiting the device via the outlet orifice.

Abstract: The present invention provides a system and method for delivery of nitric oxide to the upper respiratory tract without resulting in nitric oxide delivery to the lungs. In certain embodiments, the invention comprises the use of a flow sensor to sense the exhalation of the subject, and delivering a nitric oxide containing gas upon sensed exhalation.

Abstract: An adapter assembly including a manifold and a valve assembly. The valve assembly includes a seat and a valve body having a circular base and a wall. The wall extends from a trailing side of the base to form a dome-like shape terminating at an end at which a slit is formed, with the wall defining opposing sealing edges at the slit. The seat has an upper circumferential surface and a lower circumferential surface. The upper surface engages a leading side of the base, whereas the lower surface engages a trailing side. At least one of the upper and lower surfaces forms a segment of increased height. Upon final assembly, the valve body is disposed across a passageway of the manifold, with the slit providing a selectively openable path. A force imparted by the segment of increased height flexes the base and biases the sealing edges into engagement.

Abstract: An oral appliance assembly is described. The assembly includes an oral appliance component having an upper teeth tray and a lower teeth tray. The assembly further includes a module releasably connected to the oral appliance. The module includes at least one sensor that is positioned outside of the mouth and underneath the nares of a subject's nose when the oral appliance component is positioned in the subject's mouth. A method of measuring user compliance of an oral appliance is also described. The method includes positioning an oral appliance in the mouth of a subject, measuring at least one parameter of airflow from the subject's nose or mouth, and determining compliance based on the at least one measured parameter. A method of measuring effectiveness of an oral appliance is also described.

Abstract: Topical exposure of nitric oxide gas to wounds such as chronic non-healing wounds may be beneficial in promoting healing of the wound and in preparing the wound bed for further treatment and recovery. Nitric oxide gas may be used, for example, to reduce the microbial infection and burden on these wounds, manage exudate secretion by reducing inflammation, upregulate expression of endogenous collagenase to locally debride the wound, and regulate the formation of collagen. High concentration of nitric oxide ranging from about 160 to 400 ppm may be used without inducing toxicity in the healthy cells around a wound site. Additionally, exposure to the high concentration for a first treatment period reduces the microbial burden and inflammation at the wound site and increase collagenase expression to debride necrotic tissue at the wound site.

Abstract: A metered dose inhaler (MDI) spacer has a body that defines a dose receiving chamber. A proximal end portion coupled between the body and a mouth port through which a metered dose may be inhaled by a user of the MDI spacer. A distal end portion is coupled with the body. A combined one-way and flow rate control valve coupled with the distal end portion is configured for permitting external airflow into and prohibiting internal airflow out of the dose receiving chamber. A collar coupled with the distal end portion is configured for receiving an actuator shaft of a metered dose inhaler and for forming a seal about an aerosol nozzle of the metered dose inhaler such that a metered dose of medication is admissible into the dose receiving chamber via the collar while airflow into and out of the dose receiving chamber via the collar is prohibited.

Abstract: The present invention is directed to a Continuous Positive Airway Pressure Device as an apparatus configured to provide positive airway pressure in a respiratory circuit that comprises a container configured to be filled to a preselected level with liquids; a drop tube assembly comprising a hollow gas tube rotatably mounted in said container having an upper end extending a static distance outwardly of the container and connected to a respiratory circuit downstream of a user, and a hollow drop tube reciprocally movable upwardly and downwardly in the liquid in response to rotational movement of the gas tube. The container is provided with a gas vent and a liquid fill port.

Abstract: A method of measuring a user's adherence to a medication schedule is described. The method includes the steps of tracking the time between medication doses, alerting the user when it is time to take a medication dose, tracking the elapsed time between the alert and when the user takes the medication dose, and comparing the elapsed time to a scoring metric to calculate a score, wherein the score is representative of the user's adherence to the medication schedule. An automated system for measuring a user's adherence to a medication schedule is also described. The system includes a computing device that executes a software application that includes a tracking mechanism that alerts the user when a next medication dose is to be taken and tracks the amount of elapsed time from the alert to the time that the user takes the medication dose, and a scoring mechanism that compares the amount of elapsed time to a scoring metric to determine a medication adherence score.

Abstract: A gas regulator is described. The gas regulator includes a gas inlet having an attachment mechanism for attaching to a gas container, a gas outlet in fluid communication with the gas inlet and further in fluid communication with a gas delivery system, a pressure regulator, a pressure sensor and a NFC sensor. A method of entering at least one information item relating to a gas source to a gas delivery system control unit. The method includes the steps of providing a gas source having a NFC tag that includes at least one information item stored in a memory of the NFC tag, attaching a regulator that includes a NFC sensor, wherein the NFC sensor is positioned to read the NFC tag when attached to the gas source, reading the at least one information item via the NFC sensor, and transmitting the at least one information item read by the NFC sensor to a gas delivery system control unit.

Abstract: A device and method for reducing heat loss in at least one region of a subject's body is described. The device includes a mask component, a heat releasing reservoir, and a conduit connecting the mask component to the heat releasing reservoir and creating an airflow path therethrough, wherein the heat releasing reservoir includes at least one air permeable region that is impermeable to condensed water. Heat loss is reduced by the subject positioning the mask over the mouth and/or nose, positioning the heat releasing reservoir over the region of the subject's body, and passing warmed air exhaled by the subject into the mask through the conduit and into the heat releasing reservoir, such that the warmed air passes through the heat releasing reservoir while retaining condensed water within the heat releasing reservoir, thereby increasing the temperature of the air surrounding the at least one region of the subject's body.

Abstract: The present invention is directed to the administration of aerosolized particles to specific area of the lungs, and in particular to the targeted delivery of aerosolized pharmaceutical formulations to a specific area of the lungs. More specifically, the present invention relates to devices and methods for depositing aerosolized particles to a specific area of the lungs by regulating aerosolizing parameters of the device. The present invention also relates to devices, systems and methods for disease management, where the aerosolizing parameters are adjusted based on monitoring at least one health parameter.