WO2018127591A1 - Distributeur d'aérosol à jet - Google Patents

Distributeur d'aérosol à jet Download PDF

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Publication number
WO2018127591A1
WO2018127591A1 PCT/EP2018/050377 EP2018050377W WO2018127591A1 WO 2018127591 A1 WO2018127591 A1 WO 2018127591A1 EP 2018050377 W EP2018050377 W EP 2018050377W WO 2018127591 A1 WO2018127591 A1 WO 2018127591A1
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WO
WIPO (PCT)
Prior art keywords
aerosol
jet
gas
aerosol dispenser
nasal cannula
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PCT/EP2018/050377
Other languages
English (en)
Inventor
Laurent VECELLIO NONE
Francois REMINIAC
Stephan EHRMANN
Original Assignee
INSERM (Institut National de la Santé et de la Recherche Médicale)
Universite De Tours
Centre Hospitalier Regional Universitaire De Tours
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Application filed by INSERM (Institut National de la Santé et de la Recherche Médicale), Universite De Tours, Centre Hospitalier Regional Universitaire De Tours filed Critical INSERM (Institut National de la Santé et de la Recherche Médicale)
Publication of WO2018127591A1 publication Critical patent/WO2018127591A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/06—Sprayers or atomisers specially adapted for therapeutic purposes of the injector type
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/06—Respiratory or anaesthetic masks
    • A61M16/0666—Nasal cannulas or tubing
    • A61M16/0672—Nasal cannula assemblies for oxygen therapy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/08—Bellows; Connecting tubes ; Water traps; Patient circuits
    • A61M16/0875—Connecting tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1075—Preparation of respiratory gases or vapours by influencing the temperature
    • A61M16/1085—Preparation of respiratory gases or vapours by influencing the temperature after being humidified or mixed with a beneficial agent
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/1075—Preparation of respiratory gases or vapours by influencing the temperature
    • A61M16/1095—Preparation of respiratory gases or vapours by influencing the temperature in the connecting tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/10—Preparation of respiratory gases or vapours
    • A61M16/14—Preparation of respiratory gases or vapours by mixing different fluids, one of them being in a liquid phase
    • A61M16/16—Devices to humidify the respiration air
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. mouth-to-mouth respiration; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2209/00—Ancillary equipment
    • A61M2209/08—Supports for equipment
    • A61M2209/088—Supports for equipment on the body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2240/00—Specially adapted for neonatal use

Definitions

  • the present invention relates to the field of jet aerosol delivery circuit and jet aerosol delivery apparatus adapted for administering drug.
  • the present invention relates to jet aerosol dispensers for administering drug to a patient.
  • An aerosol is defined as a mixture of particles suspended in gas. These particles can have a size between a few nanometers and tens of micrometers.
  • the aerosol dispensers in the medical field aim at transforming a liquid drug into an aerosol that can be inhaled by the patient.
  • aerosol dispensers are composed of a chamber enclosing a reservoir filled with liquid drug, a nebulizer, an inlet pipe and an outlet pipe.
  • the aerosol is delivered to the lungs of a patient through a front-end device connected to the outlet pipe.
  • the front-end device enables the patient to inhale the aerosol.
  • the nebulizer enables the formation of an aerosol.
  • the liquid drug contained in the reservoir of the aerosol dispenser passes through the nebulizer, which separates the liquid drug into a plurality of microscopic droplets to form an aerosol.
  • the first type is the mesh nebulizer.
  • the mesh nebulizer comprises a vibrating electrical piezo component that causes a mesh to vibrate.
  • the liquid drug passes through the holes of the mesh, which separates it into a plurality of microscopic droplets to form an aerosol.
  • the second type is the jet nebulizer.
  • the jet nebulizers are much cheaper than the mesh nebulizers (thirty times cheaper). They are widely used in hospitals.
  • a jet nebulizer is commonly made of plastic. Jet nebulization was the first technical operation developed for aerosol production. It uses gas flow either from a compressor or from a central gas supply. The gas passes through a small aperture in the nebulizer in order to pick up and atomize the liquid drug.
  • the aerosol generated by atomization contains large and small droplets, and is driven to a baffle. Large droplets are impacted by the baffle and forced onto the side of the nebulizer to be recycled in liquid form in a reservoir. More than 90% of the droplets produced by atomization are selected and recirculate in the nebulizer to be recycled in the liquid-drug reservoir. Small droplets are transported out of the nebulizer by the gas to be inhaled by the patient.
  • the drug mass loaded in the nebulizer is greater than that delivered as an aerosol to the patient. Part of the drug mass is trapped in the nebulizer as residual mass and another significant part is lost in the form of aerosol particles in the ambient air during exhalation as leakage (Vecellio L, 2006, breathe).
  • the nebulizer delivers aerosol with a high flow rate of 8 liters per minutes.
  • a mouthpiece is recommended to deposit the drug directly into the lungs with minimum nose deposition.
  • the nose is a more effective filter than the mouth.
  • inhalation through the mouth is the preferred route for aerosol delivery to the lungs (Eur Respir J. 201 1 Jun;37(6):1308-31. doi: 10.1 183/09031936.00166410. Epub 201 1 Feb 10. What the pulmonary specialist should know about the new inhalation therapies.
  • a facemask involves three main problems. First, it can be complicated for a child to wear a facemask during the nebulization time. Indeed, during inhalation, children are frequently crying or being distressed, which leads to a low level of pulmonary deposition (J Aerosol Med. 2007;20 Suppl 1 :S78-83; Facemasks and aerosol delivery in vivo. Erzinger S1 , Schueepp KG, Brooks-Wildhaber J, Devadason SG, Wildhaber JH; Arch Dis Child. 1999 Aug;81 (2):163-5. Crying significantly reduces absorption of aerosolised drug in infants, lies R1 , Lister P, Edmunds AT.).
  • the aerosol delivered by the facemask can deposit on the face of the child. More particularly, the aerosol can deposit close to the eyes of the patient, which can lead to a cataract or glaucoma, depending on the delivered drug.
  • the facemasks are most effective when the patient inhales with his mouth.
  • a young child naturally inhales by his nose and he is not able to inhale with his mouth only.
  • the upper respiratory tracts of young children are very small. Because of these three facts, a facemask does not permit to a great amount of drug to be delivered to the lungs of a young child. In fact, only a small amount of drug passes the nose and pharynx of the patient if the patient is a child.
  • nasal cannula Another device for delivering product in inhalation therapy is a nasal cannula.
  • the nasal cannula is generally not recommended in aerosol therapy to cure lung illnesses. Indeed, the biggest particles are mainly deposited in the upper airway when using nasal cannula. It comes from the fact that, when entering the nostrils at a high speed, the biggest particles crash against the turbinate, for example. It follows that nasal cannula is preferable for targeting the nasal cavities (Escabasse et al, 2014).
  • the invention relates to a jet aerosol dispenser comprising a jet nebulizer, a gas inlet pipe and an aerosol outlet pipe, the gas inlet pipe and the aerosol outlet pipe being connected to the jet nebulizer, wherein the jet nebulizer comprises a baffle, a gas injector and a liquid injector, the gas injector having a diameter smaller than the liquid injector diameter and being arranged to enable expulsion of the gas coming from the gas inlet pipe and a liquid drug present in the jet nebulizer through the baffle to provide the aerosol, the gas injector having an outlet of a diameter between 0.2 mm and 0.5 mm, preferably between 0.25 mm and 0.4 mm,
  • jet aerosol dispenser further comprises a control system configured to control injection of gas in the gas inlet pipe at a flow rate less than 4L/min,
  • the present invention proposes a jet aerosol dispenser with a nasal cannula termination that allows an amount of drug deposit in the patient's lung as satisfactory as the amount deposited by using a facemask, despite large particles produced by the jet nebulizer.
  • a nasal cannula solves the problems caused by the use of facemasks.
  • the nasal cannula is well tolerated by young children, and there is no deposition of the aerosol on the face of the patient.
  • the low flow rate of 4 L/min of the outgoing aerosol reduces the aerosol deposition in the nose by impaction.
  • it reduces aerosol losses in ambient air and increases the amount of drug deposition into the lungs of the young patient.
  • the nebulizer performance is related to the gas flow rate and the gas pressure.
  • the small diameter of the gas injector enables the aerosol generation at low flow rates (2 L/min for example).
  • Using a standard jet nebulizer (with a standard gas injector diameter larger than 0.5 mm) at low flow rate (2 L/min for example) does not permit aerosol generation or it generates a too low aerosol output and a high particle size and consequently a higher duration of nebulization time not compatible with standard drug treatment (from 1 mL to 5 mL of liquid drug filled in the nebulizer reservoir).
  • the diameter of the end of the nasal cannula has an impact on the aerosol velocity and thus on the aerosol deposition in the nasal cavities.
  • Using a nasal cannula with an internal diameter as large as possible will improve the lung deposition. This diameter depends on the anatomy nostrils of the patient.
  • the nasal cannula may then extend to a free end having an internal diameter between 1 mm and 7 mm, preferably between 2 mm and 4 mm.
  • control system is a gas cylinder adjusting valve, a compressor, or a terminal unit for medical gases valve.
  • the jet nebulizer is filled with a liquid drug.
  • the gas inlet pipe is connected to the gas injector.
  • the aerosol outlet pipe is connected to an aerosol exit port of the jet nebulizer. In another aspect, the aerosol outlet pipe has a length between 30 cm and 400 cm.
  • the length of the aerosol outlet pipe leads to the deposition of the biggest particles along the pipe. Thereby, there is less particles impaction in the patient's nose, which enables a greater amount of drug deposition in the lungs of a patient.
  • the aerosol outlet pipe has a diameter between 1 mm and 20 mm.
  • the jet aerosol dispenser further comprises a support element arranged on the aerosol outlet pipe to define an insertion orientation of the nasal cannula.
  • the support element may have a contact surface intended to contact the face of the patient between the nostrils and the superior lip of the patient in an utilization position, the nasal cannula forming an angle between 45° and 90°, preferably between 70° and 90°, with a plan in which the contact surface of the support element extends when the nasal cannula is in the utilization position.
  • an outlet at the free end of the nasal cannula has a central axis forming an angle between 45° and 90°, preferably between 70° and 90°, with a plan in which the contact surface of the support element extends.
  • the nasal cannula directs the aerosol flow into the patient respiratory tracts.
  • the angle of the insertion can lead to a great amount of aerosol deposition in the patient's nose, or a great amount of aerosol deposition in the patient's lungs.
  • the aerosol flow is directed towards the lower part of the nasal cavities (under the turbinates), which enhances the amount of aerosol deposition in the lungs.
  • an expiratory one way valve is placed between the nasal cannula and the aerosol outlet pipe, allowing a fluid exhaust.
  • the nasal cannula has a nostril shape, allowing an airtight engagement with nostrils.
  • the jet aerosol dispenser comprises a humidifier connected to a heated wire.
  • the humidifier is placed between the aerosol exit port of the jet nebulizer and the nasal cannula.
  • the heated wire is placed inside the aerosol outlet pipe, at the exit port of the humidifier.
  • FIG. 1 is a schematic view representing an aerosol dispenser according to a first embodiment
  • Figure 2 is a schematic view representing an aerosol dispenser according to a second embodiment
  • Figure 3 is a schematic view representing an aerosol dispenser according to a third embodiment
  • Figures 4 - 10 illustrate some tests results.
  • FIG. 1 shows a jet aerosol dispenser 1 according to an exemplary embodiment of the invention.
  • the jet aerosol dispenser comprises a jet nebulizer 2 and a gas source 22.
  • the gas source 22 is represented by a gas bottle as an example.
  • the jet nebulizer 2 is connected to the gas source via a gas inlet pipe 3.
  • the jet aerosol dispenser also comprises a patient interface such as a nasal cannula 4.
  • the nasal cannula 4 is connected to the jet nebulizer 2 via an aerosol outlet pipe 5.
  • the nasal cannula 4 extends from an end portion of the aerosol outlet pipe 5 to a free end provided with an outlet.
  • the jet nebulizer 2 contains liquid drug 21 intended for nebulization.
  • the jet nebulizer 2 may have a variety of different shapes and sizes.
  • the jet nebulizer 2 may have a pseudo hexagonal shape in cross sectional section. In top-down view, the jet nebulizer 2 may be cylindrical.
  • the jet nebulizer 2 can be decomposed in two parts.
  • the first part is a reservoir 7 and the second part is a lid 8.
  • the jet nebulizer 2 once filled with liquid drug 21 and in position, has a lower portion characterized by the reservoir 7, and an upper portion characterized by the lid 8. It also presents a substantially vertical main axis AA, relative to which the terms lower, upper, side, horizontal and vertical are applied to the jet aerosol dispenser as a whole. Due to gravity, the liquid drug 21 will be located in the reservoir 7.
  • the connections between the jet nebulizer 2 and the gas inlet pipe 3 and between the jet nebulizer 2 and the aerosol outlet pipe 5 are placed respectively at the bottom and at the top of the jet nebulizer 2, on the central axis AA.
  • the gas inlet pipe 3 is inserted in the reservoir 7 to assure the sealing.
  • the lower part of the reservoir 7 surrounds the inserted termination of the gas inlet pipe 3 and it rises inside the reservoir 7 to form a tube inside the jet nebulizer 2.
  • This tube forms the gas injector 9.
  • the gas injector 9 has substantially the same diameter as the gas inlet pipe 3.
  • the outlet 16 of the gas injector 9 extends radially towards the central axis AA, so as to have a diameter smaller than the diameter of the entire gas injector 9.
  • a liquid injector 10 surrounds the gas injector 9 inside the reservoir 7.
  • the liquid injector 10 extends radially towards the central axis AA.
  • the diameter of the liquid injector 10 is larger than the diameter of the gas injector 9 with a small space 1 1 between the liquid and gas injectors allowing the sucking of the liquid drug.
  • the diameter of the outlet 19 of the liquid injector 10 is substantially larger than the outlet 16 of the gas injector 9.
  • the gas inlet pipe 3 receives compressed gas from the gas source at a 2L/min flow rate.
  • the compressed gas comes from a gas source.
  • the gas source is a gas cylinder, a gas terminal unit or coming from a compressor.
  • the flow rate of the compressed gas is regulated by a control system 6.
  • the control system 6 can be a valve comprised in the gas source to regulate the gas flow rate, or it can be a compressor with a constant gas flow rate.
  • the gas can for example be compressed air or oxygen.
  • the gas injector 9 pressurizes the gas. At this point, the compressed gas increases in velocity. It creates an underpressure and the liquid drug 21 is sucked up to the space 1 1 between the gas injector 9 and the liquid injector 10 and then is ejected through the outlet 19.
  • the liquid drug 21 is carried away with gas stream towards the baffle 12.
  • the liquid drug 21 is cut-off in a plurality of droplets by the impaction on the impingement surface 17 of the baffle 12. Larger particles are impacted on the reservoir 7 surface to be recycled in a liquid drug 21 , and then nebulized again.
  • the smallest droplets then arrive to the aerosol exit port 13 of the jet nebulizer 2 in aerosol form.
  • a humidifier 14 is placed between the aerosol exit port 13 and the aerosol outlet pipe 5.
  • the humidifier comprises a tank 27 filled with water, an entry port 25 and an exit port 26.
  • the entry port 25 is connected to the aerosol exit port 13 by a connection 23.
  • the exit port 26 is connected to the aerosol outlet pipe 5.
  • the humidifier is connected to a heated wire 15, which is inserted in the aerosol outlet pipe 5. The aerosol passes through the humidifier 14 and around the heated wire 15 before entering the aerosol outlet pipe 5.
  • the jet aerosol dispenser 1 comprises a support element 20.
  • the support element 20 is placed on the aerosol outlet pipe 5, just before the nasal cannula 4.
  • the support element 20 can be an insert piece of plastic, substantially thin.
  • the support element 20 indicates the suitable direction for the insertion of the nasal cannula 4 in the nostrils of the patient. In utilization position, the support element 20 has a contact surface laying on the face of the patient between the nostrils and the superior lip of the patient.
  • the nasal cannula forms an angle between 45° and 90°, preferably between 70° and 90°, with a plan BB in which the contact surface of the support element 20 extends, as shown on figure 8. More specifically, the outlet at the free end of the nasal cannula 4 has a central axis forming an angle between 45° and 90°, preferably between 70° and 90°, with the plan BB. With such configuration, the aerosol is directed towards the bottom of the nasal cavities. The bottom of the nasal cavities is relatively flat, what permits to reduce nasal deposition and increase the aerosol deposition into the patient lungs.
  • the Applicant realized a plurality of tests, illustrated in reference with the figure 4.
  • the tests have been made with the aerosol dispenser of the invention, but with different types of nasal cannula.
  • Three insertion angles for the nasal cannula have been tested: 0°, 45° and 90°.
  • the abscissa corresponds to the insertion angle of the nasal cannula in degree (DEG); the ordinates are the percentage of aerosol deposition in the lungs of a patient (DEP PUL). It appears that much more aerosol is deposited in the lungs when the nasal cannula is inserted with an angle between 45° and 90° in the patient's nostrils.
  • the nasal cannula 4 has a nostril shape to avoid the aerosol loss when the nasal cannula 4 is inserted in the patient's nostrils.
  • the nasal cannula 4 is nostril shaped to enhance the airtight of the nasal cannula 4 when it is inserted into the nostrils of the patient. Theoretically, such shape enhances the amount of aerosol deposition into the patient's lungs because patient inhale by the mouth when the inspiratory flowrate is higher than the nebulizer gas flowrate.
  • the jet aerosol dispenser 1 comprises a valve 18 to control the aerosol flow passage in the aerosol outlet pipe 5. More precisely, the valve 18 is open when a positive pressure is applied in the nasal cannula, for example during the patient expiratory phase by the nose or by the mouth for an older child or an adult, to permit aerosol exhaust. It avoids over pressure in nasal cavities if the nasal cannula is in airtight contact with the nostrils, in addition with the closing soft palate.
  • the valve 18 may be disposed at any location between the aerosol outlet pipe 5 and the nasal cannula 4.
  • the valve 18 can be made in soft plastic material with a shape memory form.
  • the valve is close when the patient inhales by the mouth or by the nose, and the valve is open when the patient exhales by the nose or by the mouth (for older children and adults).
  • the present invention proposes a jet aerosol dispenser designed to enable a massive deposition of the particles contained in the aerosol generated by a jet nebulizer into the lungs of an infant or toddler, and also for older children or adults.
  • the 2L/min flow rate induces two major advantages in the aerosol delivery for infants and toddlers.
  • a low flow rate, such as 2L/min reduces the nasal impaction phenomena.
  • the nasal impaction phenomena happens when particles enters the nostrils of a patient at a high flow rate.
  • the particles cannot follow the airstream because of their velocity and the curvatures of the nasal cavities. So the particles crash against the nasal cavities and deposit in the respiratory upper tracts, such as turbinate, ethmoids, or larynx.
  • the second advantage resides in the fact that toddlers and infants have an instantaneous respiratory flow greater than 2L/min.
  • the patient when inhaling, reduces the velocity of the aerosol coming into his nasal cavities, which reduces the deposit in nasal cavities.
  • a flow rate between 1.5 and 2.5L/min presents the same advantages as those exposed above.
  • the aerosol output and particle size are directly correlated to the gas flow rate. A lower flow rate does not allow the nebulization process or it increases the nebulization time with a non-relevant inhalation duration.
  • the above array shows the interest of choosing a flow rate between 1.5 and 2.5L/min.
  • the first column indicates the flow rate
  • the second column indicates the size of the particles
  • the third column indicates the output drug flow rate
  • the fourth column indicates the requisite duration of the nebulization to be efficient.
  • the Applicant also did some tests whose results corroborate the chosen gas flow rate values. As illustrated on the graphic figure 6, with the gas flow rate as abscissa DEB and the percentage of aerosol deposit as ordinates DEP (expressed in term of nebulizer charge), with the high flow rate (typically 8L/min), there is much more deposit on the patient nose and much less deposit in the lungs PUL comparatively to the use of a jet aerosol dispenser of the present invention delivering an aerosol at a less flow rate. More precisely, there is, on average, only 1 % of aerosol deposit in the lungs for an 8L/min gas flow rate. In contrary, for a gas flow rate between 0.5 and 2L/min, the amount of aerosol deposited in the patient lungs is on average equal to 3%.
  • the diameter of the outlet 16 of the gas injector 9 is between 0.2 and 0.5 millimeters, preferably between
  • the length and the diameter of the aerosol outlet pipe 5 are chosen so as to enable the entering of the smallest particles into the patient's nostrils.
  • the length is between 30 cm and 400 cm and the diameter is between 1 and 20 mm. Due to these values, the biggest particles deposit in the aerosol outlet pipe 5 and spread among the surface of the aerosol outlet pipe 5.
  • the liquid drug 21 thus deposited is not expulsed through the nasal cannula 4, which avoids their deposition in the nasal cannula 4. Only the smallest particles enter the patient nostrils, which leads to a great amount of deposition into the patient lungs.
  • the Applicant also drove some tests concerning the length of the aerosol outlet pipe 5.
  • the amount of aerosol deposit in the patient's lungs reaches 1 % for a length of 1 m50. With such length, the amount of aerosol deposit in the lungs is higher than the amount of aerosol deposit in the ORL system of the patient.
  • the Applicant made a comparison between the aerosol dispenser of the present invention and some aerosol dispensers already present in the market.
  • the second one is the "Hudson” (commercialized by Teleflex Medical, Le Faget, France) jet nebulizer with a child face mask.
  • the aerosol dispenser used for the comparison is an aerosol dispenser of the present invention, which presents the following characteristics:
  • Aerosol outlet pipe length 1.50m
  • the aerosol dispensers have been tested on two different "monkey groups" referenced as (1 ) and (2). Different drugs have also been tested.
  • the jet aerosol dispenser of the type of the third embodiment of the present invention has been tested.
  • the average amount of aerosol deposit in the lungs of the monkey patient (1 ) is equal to 0.85%, while the amount of deposit in the ORL system of the patient is on average equal to 3.73%.
  • Concerning the Cirrus 2 aerosol dispenser the amount of aerosol deposit in the lungs of the monkey patient (1 ) is equal to 0.71 %, while the amount of deposit in the ORL system of the patient is on average equal to 7.37%.
  • amount of aerosol deposit in the lungs of the monkey patient (2) is equal to 0.74%, while the amount of deposit in the ORL system of the patient is on average equal to 1.22%.
  • the jet aerosol dispenser has been tested without a humidifier and the amount of aerosol deposit in the lungs of the monkey patient (2) is equal to 1.27%, while the amount of deposit in the ORL system of the patient is on average equal to 0.94%.
  • the last line presents some scintigraphic images of aerosol deposit in the patient body.
  • the upper part is the ORL system of the patient, while the lower part is the patient's lungs.
  • the white large stain in the upper part of the scintigraphic image of the Cirrus 2 nebulizer corresponds to the 7.37% of aerosol deposition in the ORL system.
  • the results strictly show that the characteristics of the jet aerosol dispenser of the present invention enable a higher amount of aerosol deposit in the lungs, while the amount of aerosol deposition on the ORL system is reduced in term of quantity and in term of surface deposition (no facial deposition).
  • a jet aerosol dispenser as described above, is provided.
  • the reservoir of the jet aerosol dispenser has to be filled with liquid drug 21.
  • liquid drug 21 can be corticoids or any other drugs prescribed for lung diseases.
  • the nasal cannula is inserted into the patient's nostrils, according to the orientation as defined using the support element.
  • a compressed gas must be provided, for example from a gas cylinder or from terminal units in hospitals.
  • the injected gas flow rate is controled. It can be controlled by an adjusting valve, comprised on a gas bottle for example, that has to be set so as to inject compressed gas at a flow rate less or equal to 2L/min.
  • the compressed gas enters the gas inlet pipe.
  • the small aperture of the outlet of the gas injector induces an underpressure.
  • the underpressure enables the suction of the liquid drug 21 into the gas injector. This is called a Venturi effect.
  • the liquid drug 21 is then carried by the flow stream of the compressed gas through the impingement surface of the baffle, placed just above the gas injector.
  • the liquid drug 21 is separated in a plurality of microscopic and submicronic droplets. The smallest particles are carried by the air stream to the exit port of the jet nebulizer, whereas the biggest particles are recycled into the reservoir.
  • the small diameter of the gas injector encourages the creation of small particles and the aerosol output.
  • the aerosol is transported in the aerosol outlet pipe of the jet nebulizer and is delivered to the patient through a nasal cannula.
  • the length and the diameter of the aerosol outlet pipe enable the deposition of the biggest particles along the inner surface of the aerosol outlet pipe. Then, the patient only inhales the smallest particles that can be carried away by the airstream into his lungs.
  • the inspiratory flow can be limited by airtight nasal cannulas in the nostril.
  • a one-way expiratory valve is then added to permit the patient expiratory phase by his nose or his mouth.
  • the jet aerosol dispenser 1 can be mobile to be used in the patient's house.
  • Aerosol outlet pipe 5 Heated wire 15 50 Entry port 25

Landscapes

  • Health & Medical Sciences (AREA)
  • Pulmonology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Emergency Medicine (AREA)
  • Otolaryngology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un distributeur d'aérosol à jet (1) comprenant un nébuliseur à jet (2), un tuyau d'entrée de gaz (3) et un tuyau de sortie d'aérosol (5), le tuyau d'entrée de gaz (3) et le tuyau de sortie d'aérosol (5) étant reliés au nébuliseur à jet (2), le nébuliseur à jet (2) comprenant un déflecteur (12), un injecteur de gaz (9) et un injecteur de liquide (10), l'injecteur de gaz (9) possédant un diamètre plus petit que le diamètre de l'injecteur de liquide (10) et étant conçu pour permettre l'expulsion du gaz provenant du tuyau d'entrée de gaz (3) et d'un médicament liquide (21) présent dans le nébuliseur à jet (2) à travers le déflecteur (12) en vue de produire l'aérosol, l'injecteur de gaz (9) possédant une sortie (16) d'un diamètre entre 0,2 mm et 0,5 mm, le distributeur d'aérosol à jet (1) comprenant en outre un système de commande (6) configuré pour commander l'injection de gaz dans le tuyau d'entrée de gaz (3) à un débit inférieur à 4 L/min, et le tuyau de sortie d'aérosol (5) se terminant par une canule nasale (4).
PCT/EP2018/050377 2017-01-06 2018-01-08 Distributeur d'aérosol à jet WO2018127591A1 (fr)

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EP17305015.4 2017-01-06

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024064290A3 (fr) * 2022-09-21 2024-07-11 Oxfo Corporation Canule nasale

Citations (9)

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FR2267799A1 (en) * 1974-04-17 1975-11-14 Fenis Pierre De Respiratory device for aerosol mist or oxygen - with admixture of carbon dioxide to stimulate respiratory system
US5287847A (en) * 1992-07-24 1994-02-22 Vortran Medical Technology, Inc. Universal nebulizer
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WO2003066145A1 (fr) * 2002-02-04 2003-08-14 Fisher & Paykel Healthcare Limited Dispositif d'assistance respiratoire
WO2009117422A2 (fr) * 2008-03-17 2009-09-24 Discovery Laboratories, Inc. Adaptateur de circuit de ventilation et système de distribution d’aérosol proximal
WO2012025496A1 (fr) * 2010-08-23 2012-03-01 Nycomed Gmbh Particules humidifiées comprenant une substance thérapeutiquement active
US20140158127A1 (en) * 2012-12-07 2014-06-12 Parion Sciences, Inc. Nasal cannula for delivery of aerosolized medicaments
US20150224278A1 (en) * 2014-02-10 2015-08-13 Pneumoflex Systems, Llc Nebulized ventilation system
WO2017004404A1 (fr) * 2015-06-30 2017-01-05 Vapotherm, Inc. Canule nasale pour l'administration simultanée et continue d'un médicament sous forme d'aérosol et d'une thérapie à flux élevé

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FR2267799A1 (en) * 1974-04-17 1975-11-14 Fenis Pierre De Respiratory device for aerosol mist or oxygen - with admixture of carbon dioxide to stimulate respiratory system
US5287847A (en) * 1992-07-24 1994-02-22 Vortran Medical Technology, Inc. Universal nebulizer
US6338443B1 (en) * 1999-06-18 2002-01-15 Mercury Enterprises, Inc. High efficiency medical nebulizer
WO2003066145A1 (fr) * 2002-02-04 2003-08-14 Fisher & Paykel Healthcare Limited Dispositif d'assistance respiratoire
WO2009117422A2 (fr) * 2008-03-17 2009-09-24 Discovery Laboratories, Inc. Adaptateur de circuit de ventilation et système de distribution d’aérosol proximal
WO2012025496A1 (fr) * 2010-08-23 2012-03-01 Nycomed Gmbh Particules humidifiées comprenant une substance thérapeutiquement active
US20140158127A1 (en) * 2012-12-07 2014-06-12 Parion Sciences, Inc. Nasal cannula for delivery of aerosolized medicaments
US20150224278A1 (en) * 2014-02-10 2015-08-13 Pneumoflex Systems, Llc Nebulized ventilation system
WO2017004404A1 (fr) * 2015-06-30 2017-01-05 Vapotherm, Inc. Canule nasale pour l'administration simultanée et continue d'un médicament sous forme d'aérosol et d'une thérapie à flux élevé

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ERZINGER S1; SCHUEEPP KG; BROOKS-WILDHABER J; DEVADASON SG; WILDHABER JH, PEDIATR PULMONOL., vol. 37, no. 5, May 2004 (2004-05-01), pages 447 - 52
EUR RESPIR J., vol. 37, no. 6, June 2011 (2011-06-01), pages 1308 - 31
J AEROSOL MED., vol. 20, no. 1, 2007, pages 78 - 83

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024064290A3 (fr) * 2022-09-21 2024-07-11 Oxfo Corporation Canule nasale

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