Abstract: A fluid flow control apparatus used in medical fluid sampling. The apparatus includes a valve assembly, first and second ports, and a cap. The valve assembly comprises a body rotatably assembled to a housing and defining a passageway and at least two recesses defined by an interior surface of the housing and the body which is formed separate from the passageway. The ports extend from the housing and are configured for connection to medical devices. The valve assembly is operable to interchangeably align the passageway and the recesses with the ports. Finally, the cap is connected to the housing, and forms an opening for coupling to a specimen container.

Abstract: A bruxism guard is described. The bruxism guard includes a first U shaped tray having a top surface and a bottom surface, the top surface including a trough with a dental insert positioned therein, wherein the dental insert substantially conforms to a full arch of a subject's teeth, and a second U shaped tray having a top surface and a bottom surface, the top surface including a trough with a dental insert positioned therein, wherein the dental insert substantially conforms to a only a partial arch of the subject's teeth, wherein the bottom surfaces of the first and second trays oppose each other when positioned within the subject's mouth. Also described is a bruxism guard having a removable T-Bar that permits the bruxism guard to be interlocked in at least four different configurations.

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: The present invention relates to systems and methods for administering high concentrations of nitric oxide (NO) gas to a patient without the need to provide supplemental oxygen to the patient. The systems and methods can be used to administer high therapeutic amounts of NO gas, for example a gas comprising 160 ppm NO, while forming little or no residual nitrogen dioxide (NO2). The method is based on using a NO gas source with a relatively high NO concentration, for example 5,000 ppm, while rapidly mixing the gas from the NO gas source with air immediately prior to administering the gas to a patient.

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 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: 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 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: A retainer clip configured to engage a tubing member includes a base portion and a clamp portion which may be formed as a unitary structure. The base portion is generally disc-shaped and has a front side and a back side. The clamp portion is disposed on the base portion and extends upwardly from the front side and includes a spaced pair of clamp fingers which collectively define a slot that opens into a channel. The channel is adapted to frictionally engage the tubing member. The back side includes a layer of adhesive for adhering the retainer clip to the patient such as to the patient's skin. An interface assembly for delivering gas from a gas source to a patient includes a user interface, at least one tubing member extending from the user interface, and at least one of the retainer clips configured to anchor the tubing member to the patient.

Abstract: An integrated nasal mask is adapted for delivering gas to a patient and comprises a mask body and a pair of elongate nostril-engaging stems. The mask body is generally triangularly shaped and includes a nasal opening sized and configured to substantially envelope a patient's nose. The nasal opening opens to a nasal cavity. The nostril-engaging stems extend outwardly from the nasal cavity. Each one of the stems defines a fluid passageway for delivering gas to the patient's nose and for allowing discharge of exhalation gasses during the exhalation phase of the breathing cycle.

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.