Patent Grant
12102755
Patients with respiratory ailments may be administered supplemental breathing gases, such as oxygen, for example, to aid in respiration. These breathing gases are typically provided from a source of breathing gas, such as an oxygen tank and delivered through a delivery device, such as a nasal cannula, that is coupled to the source of breathing gas and inserted into a patient's nasal passages for delivery of the breathing gas. Separately, some respiratory medications are administered through inhalation, where the medicament or drug is aerosolized by a nebulizer and delivered to the patient's lungs by inhalation.
But delivering nebulized drug therapy though a nasal cannula poses several significant challenges. One significant problem is rain-out. This occurs when the nebulized particles condense and adhere to a surface of the device such as the inner walls of the delivery device and coalesce into large droplets. Such large droplets are usually too large to be respirable. Further, when nebulized particles are contained in a flow, any change in flow direction or turbulence can cause particles to impact a surface. This is exacerbated by high velocity flows where the change in direction is more abrupt. In such situations, the gas is able to change direction, but the inertia of the particles causes them to move toward the outside of any turn in the nasal cannula and impact the wall of the conduit. The rain-out must therefore be collected and disposed of in some way. If the rain-out is instead sent to the patient, the large drops are clinically ineffective and irritating to the patient.
Additionally, the geometric arrangement of common nasal cannulas can contribute to rainout. This can arise particularly in the case of cannulas having small cross sections and one or more directional changes. Rain-out occurs where the gases flow through the cannula at high velocity but collide with the wall at the directional change areas, leading to droplet formation. In some situations, a high percentage of nebulized drug will rain out, in some cases as high as 75% of the nebulized drug.
In many available systems, nebulization of the drug occurs either near a capital unit located away from the patient (machine proximate nebulization) or near the patient (patient proximate nebulization). Each method of nebulization has their challenges.
In machine proximate nebulization, because the capital unit is located away from the patient, the nebulized particles must travel in the gas flow path along the length of the delivery tube before reaching the patient. The longer the nebulized particles travel along the gas flow path, the greater the chance of rain-out occurring in the delivery tube. Further, as the delivery tube essentially comprises an extended lumen with a proximal end and a distal end, the distal end coupled to a cannula connected to the patient, there is no opportunity to collect rain-out that occurs in the delivery tube or the cannula. This can result in the rain-out being delivered to the patient, which is undesirable.
In patient proximate nebulization, the nebulizer is placed on the patient. Any rain-out that is collected must be transported away from the patient. This may involve either emptying a reservoir regularly or providing a conduit to carry the drug away from the patient.
Nebulized drug therapy can also be implemented by using entrainment to introduce the nebulized particles in the gas flow path. Here, the nebulized drug particles are contained in a conduit separate from that containing the flow of breathing gas. These nebulized drug particles are carried by a low velocity gas flow and combine with the nasal cannula at the prongs of the cannula. The low pressure zone created by the high velocity flow of breathing gas draws the nebulized particles into the flow of breathing gas and carries them to the patient via the prongs of the cannula.
Some nebulizers are cumbersome and often involve a multitude of orientation-specific components, such as a reservoir containing the drug and connected to a section of 22 mm diameter respiratory tubing. Owing to the size, shape and required orientation of such nebulizers, generation of nebulized particles at the entrainment site would require the caregiver or patient to hold the nebulizer in a precise location and orientation for an extended period of time during the course of the treatment.
Disclosed herein are approaches for addressing various of the problems and shortcomings of the state of the art, as identified above. More particularly, disclosed herein are systems and methods for providing respiratory therapy to a patient. According to a first embodiment of the present disclosure, there is provided a system comprising a nasal cannula and a nebulizer. The nasal cannula comprises at least at one nasal prong, tubing configured to receive breathing gas from a breathing gas source, and a breathing gas conduit disposed between the nasal prong and the tubing. The nasal prong has a proximal tip configured to be positioned within the patient's nare and a distal end connected to the breathing gas conduit. The breathing gas conduit has an inlet port in fluid communication with the tubing, an outlet port in fluid communication with the distal end of the nasal prong, and a walled flow path connecting the inlet and outlet ports, such that, when in use, the conduit directs the breathing gas from the tubing to the proximal tip of the nasal prong. The walled flow path has a luminal interior, a distal exterior surface and a proximal exterior surface, wherein the proximal exterior surface is positioned between the distal exterior surface and the proximal tip of the nasal prong and is configured to be placed adjacent the patient when in use. The nebulizer is secured to the nasal cannula and is adapted to receive and deliver a medicament. Embodiments of the nebulizer use a vibrating mesh operable to aerosolize the medicament wherein the medicament is transformed from a liquid into an aerosol of medicament particles. The nebulizer (e.g., the vibrating mesh) may be secured to the nasal cannula. The nebulizer (e.g., the vibrating mesh) may be positioned adjacent to the breathing gas conduit and configured such that, during aerosolization, the aerosol is entrained with the breathing gas at an entrainment zone located near the exit port of the nasal prong. In this configuration, liquid medicament to be fed directly to the nebulizer at the point of aerosol generation, thus minimizing rain-out that would have occurred in a delivery tube had the aerosolized medicament been generated elsewhere and transported to the nasal cannula. This increases the efficacy of medicament delivery.
In certain implementations, the nasal cannula may comprise two nasal prongs. The vibrating mesh may be positioned between the two nasal prongs. One nasal prong may be shorter than the other nasal prong. In certain implementations, the cannula may comprise an antechamber between the nasal prongs into which the aerosol is provided.
In some implementations, the vibrating mesh may be positioned distal of the proximal tip of the nasal prong. In further implementations, the vibrating mesh may be positioned between the distal exterior surface and the proximal tip of the nasal prong. In certain implementations, the vibrating mesh may be positioned on top of the breathing gas conduit. In some implementations, the vibrating mesh may be positioned axially between the proximal tip of the nasal prong and the distal end of the nasal prong. In further implementations, the vibrating mesh may be positioned at the distal exterior surface of the breathing gas conduit. In certain implementations, the vibrating mesh may be positioned at the proximal exterior surface of the breathing gas conduit. In some implementations, the vibrating mesh may be adjacent to the distal exterior surface of the breathing gas conduit. In the aforementioned configurations, the position of the aerosol generating mesh of the nebulizer is precisely specified in relation to the geometry of the cannula and nasal prongs. Such a configuration ensures that the initial velocity of the aerosol particles is directed towards an entrainment zone at the tip of the nasal prongs such that the medicament can be drawn into the flow of breathing gas emerging from the nasal prongs slipstream.
In certain implementations, the nebulizer may be secured to the nasal cannula with any one of a clamp, a snap-fit connector, and an I-connector. In some implementations, the inlet port and the outlet port of the breathing gas conduit may be contiguous with the nasal cannula tubing. The inlet port of the breathing gas conduit may be formed in the nasal cannula tubing. In certain implementations, the system may further comprise an outlet tube positioned so as to direct the aerosol to the entrainment zone. The outlet tube may be shorter than the nasal prong.
In further implementations, the nebulizer may be contained in a housing that comprises a reservoir for the medicament. In certain implementations, the nebulizer may further comprise a piezoelectric ring that may be connected to the vibrating mesh. The housing may contain the piezoelectric ring. The housing may comprise electrical contacts extending from the piezoelectric ring to an exterior of the housing. The vibrating mesh may be operable to aerosolize the medicament upon receipt of an electric signal at the electrical contacts. In certain implementations, the housing may contain O-rings to achieve a liquid tight seal between the reservoir and the housing.
The housing enables the nebulizer to be releasably attached to the cannula such that the vibrating mesh that secures the position of the mesh relative to the nasal prongs of the cannula. This ensures entrainment of aerosolized medicament generated by the nebulizer with the flow of breathing gas at the prongs. Such an arrangement also ensures that the efficacy of drug delivery is not compromised when the patient moves as the mesh will stay in position in the cannula housing. The cannula may be provided with a housing that attaches to the cannula tubing, onto which the nebulizer can be releasably attached. This eliminates the need for specially designed cannulas with an integral housing, and thus the above effects can be achieved with any cannula known in the art. The nebulizer may also be provided with a flexible attachment cuff that securely couples to the cannula tubing. This would allow the vibrating mesh nebulizer to be attached to a cannula that is already secured to the patient, thereby enabling the implementation of nebulization therapy without having to interrupt the flow of breathing gas being provided to the patient.
In some implementations, the medicament may be supplied from a supply bag to the reservoir via a feed line comprising microbore tubing. In further implementations, the medicament may be supplied to the reservoir under pressure or action of gravity. In certain implementations, the source of breathing gas may be connected to the nasal cannula via a delivery tube.
In some implementations, the electric signal may be transmitted to the nebulizer via a wire. In certain implementations, one or more of the feed line and the wire may be attached to either the nasal cannula or the delivery tube via any one of: bonding, clips, windings and a protective sheath. In further implementations, one or more of the feed line and the wire may be attached to the delivery tube via any one of: bonding, clips, windings and a protective sheath.
In some implementations, the medicament may comprise at least one of: bronchodilators, surfactants and antibiotics. The medicament may comprise at least one of: Albuterol (Ventolin), Salbutamol (Proventil), Levosalbutamol/Levalbuterol (Xopenex), Curosurf (Chiesi Pharmaceuticals), Alveofact (Boehringer Ingelheim), Survanta (Abbott Laboratories), Exosurf (Glaxo Wellcome), Surfaxin (Discovery Laboratories), macrolides, erythromycin, clarithromycin, azithromycin, glycopeptides, vancomycin, teicoplanin, oxazoldinone, quinupristin/dalfopristen, aminoglycosides, gentamicin, tobramycin, amikacin, streptomycin, netilmicin, quinolones, ciprofloxacin, ofloxacin, levofloxacin, tetracyclines, oxytetracycline, doxycycline, minocycline, cotrimoxazole, colistin, imepinim, and meripenim.
According to a second embodiment of the present disclosure, there is provided a system comprising a nebulizer and a nasal cannula. The nebulizer comprises a vibrating mesh operable to generate an aerosolized medicament. The nasal cannula comprises a nosepiece having at least one nasal prong, the nasal prong having a first end connected to the cannula, and a second end configured to be positioned within the patient's nare, the nasal cannula being in fluid communication with the nosepiece and the nasal prong and configured to provide a flow of breathing gas from a source of breathing gas to the patient via the second end of the nasal prong, the nosepiece having a distal exterior surface and a proximal exterior surface. The nebulizer is operably attached to the nasal cannula such that when the nasal cannula is secured to the patient, the proximal exterior surface of the nosepiece is configured to be adjacent to the patient, and the vibrating mesh is positioned at a nebulizing distance measured from the second end of the nasal prong to the distal exterior surface of the nosepiece. In this configuration, the amount of aerosol coalescing into droplets in the nasal cannula within the nebulizing distance after exiting the vibrating mesh is minimized, thereby enabling the aerosol to be introduced into the flow of breathing gas at an entrainment zone outside the second end of the at least one nasal prong.
In some implementations, the percentage of aerosol that coalesces into droplets is less than any of: about 50%, about 45%, about 40%, about 35%, about 30%, about 25%, about 20%, about 15%, about 10%, about 5%, and about 0%.
In certain implementations, the nasal cannula may comprise two nasal prongs. The vibrating mesh may be positioned between the two nasal prongs. One nasal prong may be shorter than the other nasal prong. In certain implementations, the cannula may comprise an antechamber between the nasal prongs into which the aerosol is provided.
In some implementations, the vibrating mesh may be positioned on top of the breathing gas conduit. In certain implementations, the vibrating mesh may be positioned distal of the proximal tip of the nasal prong. In some implementations, the vibrating mesh may be positioned axially between the proximal tip of the nasal prong and the distal end of the nasal prong. In further implementations, the vibrating mesh may be positioned at the distal exterior surface of the breathing gas conduit. In certain implementations, the vibrating mesh may be positioned at the proximal exterior surface of the breathing gas conduit. In some implementations, the vibrating mesh may be adjacent to the distal exterior surface of the breathing gas conduit. In the aforementioned configurations, the position of the aerosol generating mesh of the nebulizer is precisely specified in relation to the geometry of the cannula and nasal prongs. Such a configuration ensures that the initial velocity of the aerosol particles is directed towards an entrainment zone at the tip of the nasal prongs such that the medicament can be drawn into the flow of breathing gas emerging from the nasal prongs slipstream.
In certain implementations, the nebulizer may be secured to the nasal cannula with any one of a clamp, a snap-fit connector, and an I-connector. In some implementations, the inlet port and the outlet port of the breathing gas conduit may be contiguous with the nasal cannula tubing. The inlet port of the breathing gas conduit may be formed in the nasal cannula tubing. In certain implementations, the system may further comprise an outlet tube positioned so as to direct the aerosol to the entrainment zone. The outlet tube may be shorter than the nasal prong.
In further implementations, the nebulizer may be contained in a housing that comprises a reservoir for the medicament. In certain implementations, the nebulizer may further comprise a piezoelectric ring that may be connected to the vibrating mesh. The housing may contain the piezoelectric ring. The housing may comprise electrical contacts extending from the piezoelectric ring to an exterior of the housing. The vibrating mesh may be operable to aerosolize the medicament upon receipt of an electric signal at the electrical contacts. In certain implementations, the housing may contain O-rings to achieve a liquid tight seal between the reservoir and the housing.
The housing enables the nebulizer to be releasably attached to the cannula such that the vibrating mesh that secures the position of the mesh relative to the nasal prongs of the cannula. This ensures entrainment of aerosolized medicament generated by the nebulizer with the flow of breathing gas at the prongs. Such an arrangement also ensures that the efficacy of drug delivery is not compromised when the patient moves as the mesh will stay in position in the cannula housing. The cannula may be provided with a housing that attaches to the cannula tubing, onto which the nebulizer can be releasably attached. This eliminates the need for specially designed cannulas with an integral housing, and thus the above effects can be achieved with any cannula known in the art. The nebulizer may also be provided with a flexible attachment cuff that securely couples to the cannula tubing. This would allow the vibrating mesh nebulizer to be attached to a cannula that is already secured to the patient, thereby enabling the implementation of nebulization therapy without having to interrupt the flow of breathing gas being provided to the patient.
In some implementations, the medicament may be supplied from a supply bag to the reservoir via a feed line comprising microbore tubing. In further implementations, the medicament may be supplied to the reservoir under pressure or action of gravity. In certain implementations, the source of breathing gas may be connected to the nasal cannula via a delivery tube.
In some implementations, the electric signal may be transmitted to the nebulizer via a wire. In certain implementations, one or more of the feed line and the wire may be attached to either the nasal cannula or the delivery tube via any one of: bonding, clips, windings and a protective sheath. In further implementations, one or more of the feed line and the wire may be attached to the delivery tube via any one of: bonding, clips, windings and a protective sheath.
In some implementations, the medicament may comprise at least one of: bronchodilators, surfactants and antibiotics. The medicament may comprise at least one of: Albuterol (Ventolin), Salbutamol (Proventil), Levosalbutamol/Levalbuterol (Xopenex), Curosurf (Chiesi Pharmaceuticals), Alveofact (Boehringer Ingelheim), Survanta (Abbott Laboratories), Exosurf (Glaxo Wellcome), Surfaxin (Discovery Laboratories), macrolides, erythromycin, clarithromycin, azithromycin, glycopeptides, vancomycin, teicoplanin, oxazoldinone, quinupristin/dalfopristen, aminoglycosides, gentamicin, tobramycin, amikacin, streptomycin, netilmicin, quinolones, ciprofloxacin, ofloxacin, levofloxacin, tetracyclines, oxytetracycline, doxycycline, minocycline, cotrimoxazole, colistin, imepinim, and meripenim.
According to a third embodiment of the present disclosure, there is provided a method for providing respiratory therapy to a patient. The method comprises attaching a source of breathing gas to a cannula comprising at least one nasal prong, the nasal prong being in fluid connection with the cannula such that a flow of breathing gas from the source of breathing gas is provided to a patient when a proximal tip of the nasal prong is positioned within the patient's nare. The method also comprises attaching a nebulizer to the nasal cannula, the nebulizer having a vibrating mesh secured to the nasal cannula and operable to aerosolize a medicament received by the nebulizer such that the aerosol generated by the vibrating mesh passes into the atmosphere. Further, the method comprises entraining the aerosol into the flow of breathing gas at an entrainment zone located at the proximal tip of the nasal prong. In this configuration, the amount of aerosol coalescing into droplets in the nasal cannula within the nebulizing distance after exiting the vibrating mesh is minimized, thereby enabling the aerosol to be introduced into the flow of breathing gas at an entrainment zone outside the second end of the at least one nasal prong.
In some implementations, the nasal cannula may comprise two nasal prongs such that the vibrating mesh may be positioned between the two nasal prongs. In certain implementations, the cannula may comprise an antechamber between the nasal prongs into which the aerosol is provided. In some implementations, the vibrating mesh may be positioned on top of the nasal prong. In certain implementations, the vibrating mesh may be positioned distal of the proximal tip of the nasal prong. In further implementations, the vibrating mesh may be positioned axially between the proximal tip of the nasal prong and the distal end of the nasal prong. In the aforementioned configurations, the position of the aerosol generating mesh of the nebulizer is precisely specified in relation to the geometry of the cannula and nasal prongs. In some implementations, the method further comprises directing the aerosol to the entrainment zone via an outlet tube. Such a configuration ensures that the initial velocity of the aerosol particles is directed towards an entrainment zone at the tip of the nasal prongs such that the medicament can be drawn into the flow of breathing gas emerging from the nasal prongs slipstream.
In certain implementations, the method further comprises providing an electric signal to the vibrating mesh of the nebulizer via a wire to enable aerosolization of the medicament. In some implementations, the method further comprises supplying the medicament to the nebulizer from a supply bag via a feed line comprising microbore tubing. In further implementations, the method additionally comprises connecting the source of breathing gas to the nasal cannula via a delivery tube. In certain implementations, the method comprises attaching one or more of the feed line and the wire to either the nasal cannula or the delivery tube via any one of: bonding, clips, windings and a protective sheath. In other implementations, the method comprises attaching one or more of the feed line, the wire and the nasal cannula to the delivery tube via any one of: bonding, clips, windings and a protective sheath.
In some implementations, the medicament may comprise at least one of: bronchodilators, surfactants and antibiotics. The medicament may comprise at least one of: Albuterol (Ventolin), Salbutamol (Proventil), Levosalbutamol/Levalbuterol (Xopenex), Curosurf (Chiesi Pharmaceuticals), Alveofact (Boehringer Ingelheim), Survanta (Abbott Laboratories), Exosurf (Glaxo Wellcome), Surfaxin (Discovery Laboratories), macrolides, erythromycin, clarithromycin, azithromycin, glycopeptides, vancomycin, teicoplanin, oxazoldinone, quinupristin/dalfopristen, aminoglycosides, gentamicin, tobramycin, amikacin, streptomycin, netilmicin, quinolones, ciprofloxacin, ofloxacin, levofloxacin, tetracyclines, oxytetracycline, doxycycline, minocycline, cotrimoxazole, colistin, imepinim, and meripenim.
According to a fourth embodiment of the present disclosure, there is provided nebulizer for generating a flow of aerosolized medicament for delivery to a patient. The nebulizer comprises a chamber having an inlet, an outlet and a pressure port. The nebulizer also comprises a feed tube coupled to the inlet of the chamber for delivery of a liquid medicament from a remote source to the chamber. Further, the nebulizer comprises an aerosol generator coupled to the outlet of the chamber and operable to aerosolize the liquid medicament, the aerosol generator having an inner surface in fluidic contact with the liquid medicament, and an outer surface from which the aerosolized medicament is released for delivery to the patient. Additionally, the nebulizer comprises a pressure adjustment element in communication with the pressure port and configured to regulate the pressure within the chamber such that the pressure at the inner and outer surfaces of the aerosol generator is substantially the same.
In some implementations, the aerosol generator is a vibrating mesh. In certain implementations, the pressure at the inner and outer surfaces of the aerosol generator is maintained at atmospheric pressure. In other implementations, the liquid medicament is drip fed onto the inner surface of the aerosol generator. In some implementations, the liquid medicament is drip fed onto the inner surface of the aerosol generator at atmospheric pressure under the action of gravity. In certain implementations, the inlet connects to a nozzle within the chamber that enables the liquid medicament to be drip fed onto the inner surface of the aerosol generator. In other implementations, the feed tube extends into the chamber and is configured to deliver the liquid medicament directly onto the inner surface of the aerosol generator such that the liquid medicament leaving the feed tube immediately forms a meniscus on the inner surface of the aerosol generator.
In some implementations, the chamber forms a reservoir that is at least partially filled with the liquid medicament such that the liquid medicament is in constant contact with the inner surface of the aerosol generator. In certain implementations, a space develops between the pressure port and the liquid level of the medicament in the chamber. In other implementations, the pressure adjustment element comprises a permeable membrane. In some implementations, the pressure adjustment element additionally comprises a perforated vent. In certain implementations, the permeable membrane comprises a Gore-Tex material. In other implementations, the liquid medicament completely fills the chamber such that the medicament is in contact with the pressure adjustment element and the inner surface of the aerosol generator.
In certain implementations, the pressure adjustment element comprises a compliant diaphragm that is configured to deform in order to regulate the pressure within the chamber. In some implementations, the pressure port and outlet are vertically positioned such that the pressure port is located at a topmost section of the chamber, and the outlet is located at the bottommost section of the chamber. In other implementations, the nebulizer further comprises a piezoelectric ring that is connected to the aerosol generator. In certain implementations, the aerosol generator is operable to aerosolize the liquid medicament upon receipt of an electric signal via electrical contacts connected to the piezoelectric ring. In some implementations, the nebulizer contains O-rings around the outlet to achieve a liquid tight seal between the chamber and the atmosphere. In other implementations, the liquid medicament comprises at least one of: bronchodilators, surfactants and antibiotics.
In some implementations, the medicament comprises at least one of: Albuterol (Ventolin), Salbutamol (Proventil), Levosalbutamol/Levalbuterol (Xopenex), Curosurf (Chiesi Pharmaceuticals), Alveofact (Boehringer Ingelheim), Survanta (Abbott Laboratories), Exosurf (Glaxo Wellcome), Surfaxin (Discovery Laboratories), macrolides, erythromycin, clarithromycin, azithromycin, glycopeptides, vancomycin, teicoplanin, oxazoldinone, quinupristin/dalfopristen, aminoglycosides, gentamicin, tobramycin, amikacin, streptomycin, netilmicin, quinolones, ciprofloxacin, ofloxacin, levofloxacin, tetracyclines, oxytetracycline, doxycycline, minocycline, cotrimoxazole, colistin, imepinim, and meripenim.
According to a fifth embodiment of the present disclosure, there is provided a system for providing respiratory therapy to a patient. The system comprises a nasal cannula having at least at one nasal prong, tubing configured to receive breathing gas from a breathing gas source, and a breathing gas conduit disposed between the nasal prong and the tubing, the nasal cannula configured to generate a flow of breathing gas from the at least one nasal prong. The system further comprises a nebulizer according to any of the preceding claims, operable to generate a flow of aerosolized medicament. Further, the system comprises a reservoir of liquid medicament located remote from the nebulizer and arranged to supply the nebulizer with the liquid medicament, wherein the nasal cannula is configured to deliver the flow of breathing gas and the flow of aerosolized medicament to the patient for inhalation thereof.
In certain implementations, the nebulizer is coupled to the nasal cannula such that the flow of aerosolized medicament is entrained into the flow of breathing gas within the breathing gas conduit of the nasal cannula and prior to delivery to the patient. In some implementations, the flow of aerosolized medicament is combined with the flow of breathing gas within the breathing gas conduit of the nasal cannula and delivered as a mixed stream to the patient via the nasal prong. In other implementations, the outlet port of the nebulizer is coupled to an opening in the tubing of the nasal cannula. In certain implementations, the outlet port of the nebulizer is in fluid communication with the breathing gas conduit.
In some implementations, the outlet of the nebulizer is coupled to the nasal cannula such that the flow of aerosolized medicament is provided to the patient by entrainment with the flow of breathing gas as the flow of breathing gas exits the at least one nasal prong for inhalation by the patient. In other implementations, the flow of aerosolized medicament is combined with the flow of breathing gas after the flow of breathing gas exits the at least one nasal prong and before inhalation by the patient. In certain implementations, the flow of aerosolized medicament and the flow of breathing gas are maintained as separate flow streams until the breathing gas exits the nasal cannula. In some implementations, the system further comprises a source of breathing gas.
Variations and modifications will occur to those of skill in the art after reviewing this disclosure. The disclosed features may be implemented, in any combination and subcombination (including multiple dependent combinations and subcombinations), with one or more other features described herein. The various features described or illustrated above, including any components thereof, may be combined or integrated in other systems. Moreover, certain features may be omitted or not implemented.
The foregoing and other objects and advantages will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:
To provide an overall understanding of the systems and methods described herein, certain illustrative implementations will be described. Although the implementations and features described herein are specifically described for use in connection with a high flow therapy system, it will be understood that all the components and other features outlined below may be combined with one another in any suitable manner and may be adapted and applied to other types of respiratory therapy and respiratory therapy devices, including low flow oxygen therapy, continuous positive airway pressure therapy (CPAP), mechanical ventilation, oxygen masks, Venturi masks, and Tracheostomy masks. Furthermore, it should be noted that while certain implementations are discussed herein with regards to systems and methods for respiratory therapy, these various implementations may be used in various combinations to increase both the efficacy of treatment and the patient's overall level of comfort during the treatment.
Disclosed herein are systems and methods that provide respiratory therapy to a patient with a nebulizer secured to a nasal cannula having at least one nasal prong. The nebulizer is described below and generates a stream of aerosolized medicament in close proximity to the nasal prongs of the cannula. The nebulizer is provided with a vibrating mesh that enables liquid medicament to be fed directly to the nebulizer at the point of aerosol generation, thus minimizing rain-out that would have occurred in a delivery tube had the aerosolized medicament been generated elsewhere and transported to the nasal cannula. This increases the efficacy of medicament delivery. The position of the aerosol generating mesh of the nebulizer is precisely specified in relation to the geometry of the cannula and nasal prongs. Such a configuration ensures that the initial velocity of the aerosol particles is directed towards an entrainment zone at the tip of the nasal prongs such that the medicament can be drawn into the flow of breathing gas emerging from the nasal prongs slipstream.
The cannula may include a housing integrally formed in the cannula tubing. The housing enables the nebulizer to be releasably attached to the cannula such that the vibrating mesh that secures the position of the mesh relative to the nasal prongs of the cannula. This ensures entrainment of aerosolized medicament generated by the nebulizer with the flow of breathing gas at the prongs. Such an arrangement also ensures that the efficacy of drug delivery is not compromised when the patient moves as the mesh will stay in position in the cannula housing. The cannula may be provided with a housing that attaches to the cannula tubing, onto which the nebulizer can be releasably attached. This eliminates the need for specially designed cannulas with an integral housing, and thus the above effects can be achieved with any cannula known in the art. The nebulizer may also be provided with a flexible attachment cuff that securely couples to the cannula tubing. This would allow the vibrating mesh nebulizer to be attached to a cannula that is already secured to the patient, thereby enabling the implementation of nebulization therapy without having to interrupt the flow of breathing gas being provided to the patient.
As shown in
In some embodiments, the feed line 145 and the connection cable 165 may be secured to the delivery tube 115 with clips positioned along the length of the delivery tube 115. In certain embodiments, the connection cable 165 may be wound around the feed line 145 and the delivery tube 115, thereby securing the feed line 145 to the delivery tube 115. In other embodiments, windings may be used to secure the feed line 145 and connection cable 165 to the delivery tube 115. In some embodiments, a protective sheath may be used to house the delivery tube 115, feed line 145 and the connection cable 165. In certain embodiments, the feed line 145 and the connection wire 165 may be secured to the nasal cannula 120 via any of the methods discussed in the foregoing. In certain embodiments, the connection wire 165 may be attached to the delivery tube 115 while the feed line 145 may be attached to the nasal cannula 120.
The source of breathing gas may be configured to provide, for example, breathing gas at flow rates between 1 and 8 liters per minute (lpm) for infants, between 5 and 20 lpm for pediatric patients, or up to 40 lpm for adults. Suitable sources of heated and humidified gas will be known to one of ordinary skill in the art. For example, the source may be the Vapotherm Flowrest System, Vapotherm Careflow System, Precision Flow unit, or the Vapotherm 2000i, all of which are provided by Vapotherm, Inc. of Exeter, New Hampshire, USA. Other suitable sources of breathing gas will be known to one of ordinary skill in the art from the description herein.
The flow of heated and humidified gas from the capital unit 110 is provided to the patient via nasal cannula 120 connected to the delivery tube 115. In some embodiments, nasal cannula 120 may comprise a first tubing 124 having a first lumen therethrough and a second tubing 126 having a second lumen therethrough, as described in U.S. patent application Ser. Nos. 13/665,100, 15/199,158 and 62/555,945, the contents of which are hereby incorporated by reference in their entirety. In certain embodiments, the first and second lumens of the nasal cannula 120 are separate from each other so as to form separate paths for the provision of the flow of breathing gas to the patient. In other embodiments, the first and second lumens of the nasal cannula 120 are connected to each other so as to form a single path for the provision of the flow of breathing gas to the patient.
In some embodiments, delivery tube 115 may have a single lumen connecting the capital unit 110 to the first and second lumens of the nasal cannula 120 for the flow of heated and humidified breathing gas therethrough. In such implementations, the connection between the single lumen delivery tube 115 and the nasal cannula 120 may be facilitated by a flow splitter to ensure division of breathing gas from the capital unit 110 to the first tubing 124 and the second tubing 126 of the nasal cannula 120. In other implementations, delivery tube 120 may comprise a dual lumen tube, where one lumen of the delivery tube 120 is in fluid communication with the first lumen of the first tubing 124 of the nasal cannula 120 and the other lumen of the delivery tube 120 is in fluid communication with the second lumen of the second tubing 126 of the nasal cannula 120.
In some embodiments, the nasal cannula 120 may further comprise a nosepiece 130 having a first nasal prong 133 and a second nasal prong 136. Nosepiece 130 comprises a first inlet 131, a second inlet 134, a first outlet 132 located on the first nasal prong 133 and a second outlet 135 located on the second nasal prong 136, of which the first inlet 131 is in fluid communication with the first outlet 132, and the second inlet 134 is in fluid communication with the second outlet 135. The nosepiece 130 is arranged such that the first lumen of the first tubing 124 of the nasal cannula is in fluid communication with the first inlet 131 and the first outlet 132 of the first nasal prong 133, and the second lumen of the second tubing 126 of the nasal cannula is in fluid communication with the second inlet 134 and the second outlet 135 of the second nasal prong 135. With such a configuration, when the nosepiece 130 is positioned adjacent the upper lip of the patient, the first nasal prong 133 is positioned in a nare of the patient while the second nasal prong 136 is positioned in the other nare of the patient. This allows the heated and humidified breathing gas generated at the capital unit 110 to be provided to the patient. As shown in
While a nasal cannula 120 comprising two nasal prongs 133, 135 has been described in the foregoing, in certain embodiments of the present disclosure the nasal cannula 120 may instead comprise a single nasal prong through which heated and humidified breathing gas is provided to a patient. Exemplary nasal cannulas include the high flow adult cannula VAPMA1700, the pediatric nasal cannula VAPMP1500, the infant cannula VAPMI1300 and the premature cannula VAPMN1100, all of which are provided by Vapotherm, Inc. of Exeter, New Hampshire, USA.
In some embodiments, nasal cannula 120 may be fabricated in a material comprising polyvinyl chloride (PVC) plastic, plastisol, vinyl, silicone, non-latex rubber, an elastomer, ethylene vinyl acetate (EVA), styrene-butadiene copolymer (SBC), polyether ether ketone (PEEK), a polyether block amide (such as PEBAX), a polyethylene material, a high-density polyethylene (HDPE) material, a medium-density polyethylene (MDPE) material, a low-density polyethylene (LDPE) material, a crack-resistant material, a material with a low coefficient of friction, a material less than 70 Durometer Shore A, or any other suitable material).
In some embodiments the nasal prongs may be integrally formed in the nasal cannula, as illustrated in
Nasal cannula 170 comprises a first breathing gas conduit 180, disposed between the distal end 173a of nasal prong 173 and the first tubing 171, and a second breathing gas conduit 190, disposed between the distal end 174a of nasal prong 174 and the second tubing 172. First breathing gas conduit 180 comprises a first inlet port 181 in fluid communication with the first lumen of the first tubing 171, a first outlet port 182 in fluid communication with the distal end 173a of the first nasal prong 173, and a first walled flow path 183 that connects the first inlet port 181 and the first outlet port 182. The first inlet port 181 and the first outlet port 182 of the first breathing gas conduit 180 are contiguous with the first tubing 171 of the nasal cannula 170. First flow path 183 comprises a first luminal interior surface 184 and a first exterior surface 185. The first exterior surface 185 is divided into a first distal exterior surface 185a and a first proximal exterior surface 185b, as shown in
Similarly, second breathing gas conduit 190 comprises a second inlet port 191 in fluid communication with the second lumen of the second tubing 172, a second outlet port 192 in fluid communication with the distal end 174a of the second nasal prong 174, and a second walled flow path 193 that connects the first inlet port 191 and the first outlet port 192. The second inlet port 191 and the second outlet port 192 of the second breathing gas conduit 190 are contiguous with the second tubing 172 of the nasal cannula 170. Second flow path 193 comprises a second luminal interior surface 194 and a second exterior surface 195. The second exterior surface 195 is divided into a second distal exterior surface 195a and a second proximal exterior surface 195b, also shown in
When the nasal cannula 170 is affixed to a patient, the first nasal prong 173 is positioned in a nare of the patient while the second nasal prong 174 is positioned in the other nare of the patient. In this position, the first proximal exterior surface 185b of the breathing gas conduit 180 is positioned adjacent the patient and between the first distal exterior surface 185a of the breathing gas conduit 180 and the proximal tip 173b of the nasal prong 173. Similarly, when the cannula 170 is attached to the patient, the second proximal exterior surface 195b of the breathing gas conduit 190 is positioned adjacent the patient and between the second distal exterior surface 195a of the breathing gas conduit 190 and the proximal tip 174b of the nasal prong 174. Once the nasal cannula 170 is attached to the patient, the first lumen of the first tubing 171 will be in fluid communication with the first breathing gas conduit 180 and the first nasal prong 173, and the second lumen of the second tubing 172 will be in fluid communication with the second breathing gas conduit 190 and the second nasal prong 174, thereby enabling the heated and humidified breathing gas generated at the capital unit 110 to be provided to the patient.
While the above description of the breathing gas conduits 180 and 190 relates to the nasal cannula 170 in
In some embodiments, an alternating voltage is supplied from a power source contained within the signal generator 160 to the piezoelectric ring 152 via connection cable 165. The alternating voltage causes the piezoelectric ring 152 to periodically contract from a rest state to a radially decreased state and back to the rest state. Due to the circumferential attachment of the mesh 156 to the piezoelectric ring 152, the contraction of the piezoelectric ring 152 to the radially decreased state causes the mesh 156 to distort or bow (as shown in
When the mesh 156 is in the rest state, liquid medicament from the reservoir 153 is not allowed through the hoes in the mesh 156. When the mesh 156 is in the distorted state, liquid medicament from the reservoir 153 is allowed though the holes in the mesh 156. At the first surface 157 of the vibrating mesh 156, the atomized medicament will grow into drops at each hole in the mesh 156 due to the surface tension of the liquid medicament. The drops will increase in size until the expelling forces arising from the movement of the vibrating mesh 156 and the mass of each drop exceeds a holding force determined by the size of the holes in mesh 156 and the surface tension of the liquid medicament. The drops are then expelled from the first surface 157 of the mesh 156 as an aerosol 220 as depicted in
In
Thus, according to the present disclosure, the aerosolized medicament 220 is generated adjacent to the breathing gas conduit 180 into the atmosphere. The aerosolized medicament 220 is then entrained into the flow of heated and humidified breathing gas 230 by the slipstream effect at an entrainment zone located proximal to the proximal tip 173b of the nasal prong 173. The generation of aerosol in such close proximity to the nasal prong removes the possibility of the aerosolized medicament impacting of the inner walls of the meandering nasal tubing if the aerosol was generated at the capital unit 110 or away from the nasal cannula 170. This minimizes rainout from occurring in the nasal cannula 170. According to certain embodiments of the present disclosure, the arrangement of the vibrating mesh nebulizer 150 with respect to the nasal cannula 170 as described in the foregoing results in less than any of: about 50%, about 45%, about 40%, about 35%, about 30%, about 25%, about 20%, about 15%, about 10%, about 5%, and about 0%, of the aerosol coalescing into droplets and rain-out in the nasal cannula 170.
While it has been described in the foregoing that the vibrating mesh 156 of the nebulizer 150 may be located adjacent to the breathing gas conduit 180 of nasal cannula 170 to achieve entrainment of the aerosol 220 in an entrainment zone 210 located at the proximal tip 173b of the nasal prong 173, the vibrating mesh 156 may be located elsewhere relative to the nasal prongs 173, 174 without deviating from the scope of the present disclosure.
For example, and with reference to
The first and second sections 320, 325 of the nebulizer housing may include O-rings 330, 335 to maintain a liquid tight seal between the liquid medicament 154 in the reservoir 153 and the rest of the nebulizer 300. Further, the first and second sections 320, 325 of the nebulizer housing may include electrical contacts 340, 345 that separately extend from a first surface and a second surface of the piezoelectric ring 152 to the exterior of the nebulizer housing 320, 325. Such an arrangement allows electrical signals from the signal generator 160 to be easily fed to the nebulizer 300 using cable 165 (see
In some embodiments, housing 320, 325 of nebulizer 300 may be fabricated in a material comprising polyvinyl chloride (PVC) plastic, plastisol, vinyl, silicone, non-latex rubber, an elastomer, ethylene vinyl acetate (EVA), styrene-butadiene copolymer (SBC), polyether ether ketone (PEEK), a polyether block amide (such as PEBAX), a polyethylene material, a high-density polyethylene (HDPE) material, a medium-density polyethylene (MDPE) material, a low-density polyethylene (LDPE) material, a crack-resistant material, a material with a low coefficient of friction, a material less than 70 Durometer Shore A, or any other suitable material).
The nebulizer in
Cannula 410 may comprise a housing 460 integrally formed in a bridge portion of the cannula between the first nasal prong 440 and the second nasal prong 450. Such integral formation may be achieved by molding the housing 460 with the body of cannula 410 during fabrication. Housing 460 may be a shell that enables the nebulizer 300 to attach to cannula 410. In such a configuration, the first and second lumens are not in fluid communication with each other in the bridge portion of the cannula between the nasal prongs 440, 450. Attachment of the nebulizer 300 to housing 460 may be provided by any arrangement that releasably attaches the nebulizer 300 to the housing 460. For example the attachment between housing 460 and the nebulizer 300 may be a snap fit. Housing 460 may additionally comprise a port 470 positioned at any point between the first nasal prong 440 and the second nasal prong 450. Port 470 defines an opening in the housing 460. Port 470 is positioned such that the opening in the housing 460 is aligned with the first surface 157 of the vibrating mesh 156 of nebulizer 300 so as to expose the first surface 157 to the atmosphere. The diameter of the port 470 may be greater than the diameter of the mesh 156 so as to ensure that all the aerosol 220 generated at the first surface 157 of the vibrating mesh 156 is emitted from the cannula 410 and not caught between the housing 460 and the nebulizer 300. In some embodiments, the housing 460 is positioned between the first nasal prong 440 and the second nasal prong 450. In some embodiments, the nasal prongs 440, 450 may be formed in a nosepiece (similar to nosepiece 130 in
When the nebulizer 300 is coupled to the housing 460, the position of the mesh 156 will be fixed relative to the cannula 410 and the first and second nasal prongs 440, 450. The present disclosure includes variations in the design of the housing 460 and location of the housing 460 on the cannula 410 such that the position of the mesh 156 relative the features of the cannula 410 may be varied as described in the foregoing with respect to
As described in the foregoing with respect to
The integrated housing 460 in cannula 410 enables the nebulizer 300 to easily (and releasably) attach to the cannula 410. This makes for a light and less cumbersome nebulizer cannula that can be easily attached to the patient. As the nebulizer 300 is effectively locked in position within the cannula housing 460, operation of the nebulizer 300 and the direction of flow of the aerosol 220 is less likely to be affected by movement of the patient.
Cannula 510 may comprise a housing 560 that is attached to the bridge of the cannula between the first nasal prong 540 and the second nasal prong 550. Such attachment may be provided by any arrangement that releasably attaches the housing 560 to the nasal cannula 510. For example the housing 560 may have hooks formed therein that clip onto the bridge 505 of the nasal cannula 510. In some embodiments, housing 560 may be separated in multiple sections that snap together around the bridge 505 of the cannula 510 thereby securing the housing 560 to the nasal cannula 510. Housing 560 forms a shell or cage that enables the nebulizer 300 in
When the nebulizer 300 is coupled to the housing 560, the position of the mesh 156 will be fixed relative to the cannula 510 and the first and second nasal prongs 540, 550. The present disclosure includes variations in the design of the housing 560 and point of attachment of the housing 560 to the cannula 510 such that the position of the mesh 156 relative the features of the cannula 510 may be varied as described in the foregoing with respect to
As described in the foregoing with respect to
Housing 560 is a separate entity from nasal cannula 510. This enables the housing 560 to be attached to any nasal cannula, in an adaptor-like manner for the positioning of the vibrating mesh nebulizer 300 so as to generate aerosol proximate to the nasal prongs and to entrain the generated aerosol into the flow of gas at the proximal tip of at least one nasal prong, as described in the foregoing disclosure. In this manner, no specialized cannula design is necessary thus making the embodiment of
Cannula 602 may further comprise a first coupling part 610 and a second coupling part 620. First coupling part 610 may be provided with a first flexible cuff 612 and attachment pins 613-615, and second coupling part 620 may be provided with a second cuff 622. The distal outer surface of the second cuff 622 may have a flat surface that may be attached to the proximal outer surface of a nebulizer, such as the vibrating mesh nebulizer 300 of
When the nebulizer 300 is held in a fixed position with respect to the cannula 602 by the first and second coupling parts 610, 620, the position of the mesh 156 will be fixed relative to the cannula 602 and the first and second nasal prongs 632, 634. With this arrangement, the aerosol generated by the vibrating mesh 156 will be directed to an entrainment zone at the proximal tip of at least one nasal prong 632, 634 similar to the entrainment zone 210 illustrated in
As described in the foregoing with respect to
As with housing 560 in
At step 720, a nebulizer is attached to the nasal cannula. The nebulizer may comprise a mesh having holes such that when the mesh is in a first state, liquid medicament is not permitted through the holes in the mesh, and when the mesh is in a second state, liquid medicament is permitted to pass though the holes in the mesh. The nebulizer may comprise a piezoelectric ring that surrounds the mesh. The piezoelectric ring may be reactive to an input electric signal so as to cause a change of state of the mesh from the first state to the second state (or vice versa). When the electric signal is alternating in nature, such as an alternating voltage signal, for example, the mesh vibrates thereby generating a stream of aerosolized medicament. The nebulizer may be configured in manner similar to nebulizer 300 as described in the foregoing.
At step 730, the vibrating mesh is positioned relative to the nasal prong by attaching the nebulizer to the nasal cannula. The nebulizer can be attached at any point of the nasal cannula that enables the aerosol stream from the nebulizer to be entrained in the flow of breathing gas at an entrainment zone located at the proximal tip of the nasal prong. Preferred positions of the vibrating mesh relative to the nasal prongs of the nasal cannula have been discussed in the foregoing and in relation to
The vibrating mesh 156 is positioned at the outlet 830 of the chamber 810 such that the mesh 156 is in vertical alignment with the nozzle 822 so that the termination of the drug conduit is poisoned directly above the mesh 156. In certain implementations, the outlet 830 may be circular. As described in relation to
The pressure port 840 is vertically oriented with respect to the chamber 810 and comprises an opening that vents the chamber 810 to the atmosphere. In some implementations, the pressure port 840 comprises a gas-permeable membrane 842 that is attached to the opening. In certain implementations, the gas-permeable membrane 842 may comprise a Gore-Tex or other Teflon membrane, for example. In other implementations, the pressure port may additionally have vent cover 844 that may be perforated. The gas-permeable membrane 842 and/or the cover 844 facilitate venting the chamber 810 in contact with the second surface 158 of the mesh 156 to the atmosphere.
In
As the liquid medicament does not completely fill the chamber 1030, it forms a free space 1035 between the pressure port 1040 and the surface of the liquid medicament in the chamber 1030. The free space 1035 is exposed to the atmosphere via pressure port 1040, thereby venting the chamber 1030 to the atmosphere. In some implementations, the pressure port 1040 comprises a gas-permeable membrane 1042 that is attached to the opening to the atmosphere. In certain implementations, the gas-permeable membrane 1042 may comprise a Gore-Tex or other Teflon membrane, for example. It should be noted that for venting to be possible, a volume of free space 1035 (i.e. an air gap) between the pressure port 1040 and the surface of the liquid medicament in the chamber 1030 must always be maintained to prevent the buildup of pressure within the chamber 1030. The air gap in free space 1035 is always maintained as long as the flow of liquid medicament into chamber 1030 is less than the rate at which the vibrating mesh 156 converts the liquid medicament to aerosol. The gas-permeable membrane 1042 allows any buildup of pressure in the chamber 1030 to equalize as long as there is air on both sides of the membrane 1042.
Unlike the nebulizers described in the foregoing, the inlet 1120 in nebulizer 1100 extends into the chamber 1110 such that the drug conduit is positioned very close to the inner surface 158 of the vibrating mesh 156. For example, the end of the inlet 1120 within chamber 1110 may be positioned within about 2 mm of the inner surface 158 of the mesh 156. Due to the proximity of the end of the inlet 1120 within chamber 1110 and the inner surface 158 of the mesh 156, when a droplet 1124 of liquid medicament is formed against the inner surface of the mesh 156, it is held in place by the surface tension of the liquid medicament.
A compliant diaphragm 1245 is attached to the pressure port 1240. The diaphragm 1245 is compliant in that it is able to deform to change the volume of the chamber 1210 so as to equalize the pressure of the chamber 1210 and the pressure of the atmosphere. In certain embodiments the diaphragm 1245 may be permeable to allow any trapped air bubbles in the liquid medicament to escape.
It will be understood that any of the nebulizers in
The foregoing is merely illustrative of the principles of the disclosure, and the apparatuses can be practiced by other than the described implementations, which are presented for purposes of illustration and not of limitation. It is to be understood that the apparatuses disclosed herein, while shown for use in high flow therapy systems, may be applied to systems to be used in other ventilation circuits.
Variations and modifications will occur to those of skill in the art after reviewing this disclosure. For example, in some embodiments, the conduit may be attached to the outlet opening 360 of the nebulizer 300 to direct the generated aerosol to a desired location (e.g. to the proximal tip of a nasal prong such that a greater proportion of aerosol is entrained in the flow of heat and humidified gas. In certain embodiments, the conduit may be attached to the port 470 in
In the foregoing disclosure, it will be understood that the term ‘about’ should be taken to mean within a range of ±20% of the stated value.
It will be understood that respiratory medications such as bronchodilators, surfactants or antibiotics, may be administered, independently or in combination with each other, through inhalation directly to the patient's lungs using any of the embodiments disclosed in the foregoing. Bronchodilators include, but are not limited to, any medication for treating asthma or Chronic Obstructive Pulmonary Disease (“COPD”), such as Albuterol (Ventolin), Salbutamol (Proventil), and Levosalbutamol/Levalbuterol (Xopenex), for example. Surfactants include, but are not limited to, any medication effective for treating diseases that alter the surface active properties of the lung, such as respiratory distress syndrome in premature infants (“iRDS”), acute respiratory distress syndrome (ARDS), asthma, pneumonia, acute lung injury (ALI), and meconium aspiration syndrome (MAS), for example. Surfactants for inhalation include, but are not limited to, Curosurf (Chiesi Pharmaceuticals), Alveofact (Boehringer Ingelheim), Survanta (Abbott Laboratories), Exosurf (Glaxo Wellcome), and Surfaxin (Discovery Laboratories), for example. Antibiotics include, but are not limited to, any antibiotics suitable for inhalation, such as macrolides (e.g., erythromycin, clarithromycin, azithromycin), glycopeptides (e.g. vancomycin and teicoplanin), oxazoldinone, quinupristin/dalfopristen, aminoglycosides (e.g., gentamicin, tobramycin, amikacin, streptomycin, netilmicin), quinolones (e.g., ciprofloxacin, ofloxacin, levofloxacin), tetracyclines (e.g., oxytetracycline, doxycycline, minocycline), cotrimoxazole, colistin, imepinim, and meripenim, for example. In some embodiments, any medication may be administered through inhalation directly to the patient's lungs using any of the embodiments disclosed in the foregoing.
The disclosed features may be implemented, in any combination and subcombination (including multiple dependent combinations and subcombinations), with one or more other features described herein. The various features described or illustrated above, including any components thereof, may be combined or integrated in other systems. Moreover, certain features may be omitted or not implemented.
Examples of changes, substitutions, and alterations are ascertainable by one skilled in the art and could be made without departing from the scope of the information disclosed herein. All references cited herein are incorporated by reference in their entirety and made part of this application.
This application claims priority to U.S. provisional application No. 62/678,882, filed May 31, 2018, and U.S. provisional application No. 62/832,772, filed Apr. 11, 2019, the contents of which are hereby incorporated herein by reference in their entirety.
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