EP3912614A1 - Nasal washing device for cleaning the nasal cavities of a user - Google Patents

Nasal washing device for cleaning the nasal cavities of a user Download PDF

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Publication number
EP3912614A1
EP3912614A1 EP20175420.7A EP20175420A EP3912614A1 EP 3912614 A1 EP3912614 A1 EP 3912614A1 EP 20175420 A EP20175420 A EP 20175420A EP 3912614 A1 EP3912614 A1 EP 3912614A1
Authority
EP
European Patent Office
Prior art keywords
nasal
main body
washing device
compressor unit
nasal washing
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP20175420.7A
Other languages
German (de)
French (fr)
Inventor
Alessandra RUOCCO
Luca Alberici
Ottorino BUGATTI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Air Liquide Medical Systems SRL
Original Assignee
Air Liquide Medical Systems SRL
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Air Liquide Medical Systems SRL filed Critical Air Liquide Medical Systems SRL
Priority to EP20175420.7A priority Critical patent/EP3912614A1/en
Publication of EP3912614A1 publication Critical patent/EP3912614A1/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H33/00Bathing devices for special therapeutic or hygienic purposes
    • A61H33/60Components specifically designed for the therapeutic baths of groups A61H33/00
    • A61H33/601Inlet to the bath
    • A61H33/6021Nozzles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H35/00Baths for specific parts of the body
    • A61H35/04Baths for specific parts of the body for the nose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/01Constructive details
    • A61H2201/0119Support for the device
    • A61H2201/0153Support for the device hand-held
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/01Constructive details
    • A61H2201/0165Damping, vibration related features
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/01Constructive details
    • A61H2201/0188Illumination related features
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/12Driving means
    • A61H2201/1207Driving means with electric or magnetic drive
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61HPHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00Devices for specific parts of the body
    • A61H2205/02Head
    • A61H2205/022Face
    • A61H2205/023Nose

Definitions

  • the present invention concerns a nasal washing/cleaning device for delivering a liquid solution jet, e.g. a washing/cleaning solution, such as a saline solution or the like, to the nasal cavities and/or paranasal sinuses of a user or person, especially pediatric users, such as babies, toddlers, infants or the like, thereby washing, cleaning, promoting hydration and fluidification, and allowing removal of mucus and phlegm, or the like, from the nasal areas.
  • a liquid solution jet e.g. a washing/cleaning solution, such as a saline solution or the like
  • Nasal washing devices are used for delivering a nebulized or atomized liquid solution, such as saline solutions or the like, to the nasal cavities of a person.
  • the nebulized solution contributes to the removal of excessive mucus, i.e. catarrh, present in the nasal cavities and/or paranasal sinuses of the person, thereby preparing the nasal cavities and/or paranasal sinuses for, for instance, subsequent administrations of one or several therapeutic agents, drugs or the like.
  • excessive mucus i.e. catarrh
  • the drugs or therapeutic agents that are subsequently intra-nasally administrated cannot act properly as they are stopped by the mucus and hence unable to reach the nasal areas, where they are supposed to act and/or to enter into the blood circulation of the person.
  • Nasal washing devices can be used with persons suffering from various diseases, such as rhinopharyngitis, allergic rhinitis or chronic sinusitis, and subsequently treated by antihistaminic agents, antibiotics or decongestants that are intra-nasally delivered.
  • Examples of nasal washing devices are disclosed by EP-A-2732881 and EP-A-2274033 .
  • EP-A-2732881 dislcoses a nasal washing device comprising a main body, a reservoir for containing a liquid solution to be aerosolized, nebulization means for aerosolizing the liquid solution, and a nasal interface with an exit orifice for delivering the aerosolized solution used for cleaning the nasal cavities of a user.
  • the aerosolization, i.e. atomization, of the liquid solution is obtained thanks to compressed air provided by an external compressor device that is fluidly connected to the nasal washing device by means of a flexible hose, as shown in Figure 1 .
  • EP-A-2274033 proposes a nasal washing device that is similar to the previous one except that it comprises an internal compressor unit and batteries for powering it and generating a flow of compressed air, in lieu of an external compressor device.
  • the air passage that provides ambient air to the compressor unit is located under the device, i.e. in its base, and requires a intake valve.
  • compressed-air leaks also may appear at the exit of the compressor unit that may impact the efficiency of nebulization/atomization of the liquid solution.
  • a solution according to the present invention is a nasal washing device, preferably a portable device, comprising:
  • a nasal washing device can comprise one or several of the following additional features :
  • the invention also concerns an nasal cleaning set or assembly comprising a transport bag containing a nasal washing device according to the present invention, preferably it further comprises instructions for use, such as a user's guide or the like.
  • the invention also concerns the use of a nasal washing assembly according to the invention, e.g. as above described, for washing the nasal cavities and/or paranasal sinuses of a paediatric person, such as a baby, a toddler or an infant, with a non therapeutically-active solution chosen among a saline solution, a hypertonic solution or thermal water.
  • Figure 1 shows a nasal washing device 111 as taught by EP-A-2732881 . It comprises a main body 114, a reservoir (not visible) for containing a liquid solution to be aerosolized, nebulization means (not visible) for aerosolizing the liquid solution, and a nasal interface 112 with an exit orifice 115 for delivering the aerosolized solution for cleaning the nasal cavities of a user.
  • Compressed air is provided by an external compressor device 116, i.e. an independant compressed-air generator, that is fluidly connected to the nasal washing device 111 by means of a flexible hose 117 that is plugged to a connector 113 of the main body 114.
  • Figures 2 and 4 show an embodiment of a nasal washing device 1 according to the present invention, preferably a portable device, that is configured for delivering a jet of aerosolized or nebulized solution, also called mist or aerosol, into the nasal cavities, i.e. nostrils, of a person for washing said nasal cavities and/or paranasal sinuses.
  • a nasal washing device 1 preferably a portable device, that is configured for delivering a jet of aerosolized or nebulized solution, also called mist or aerosol, into the nasal cavities, i.e. nostrils, of a person for washing said nasal cavities and/or paranasal sinuses.
  • the nasal washing device 1 comprises, as shown in Figures 2 and 4 , a main body 4 comprising an electrically-driven compressor unit 5 (cf. Fig. 8 and 9 ) for providing compressed air; a reservoir 3, also called liquid tank member or liquid tank, for containing a liquid solution to be aerosolized, such as a saline solution, that is arranged above and coupled to the main body 4; nebulization means 7 for aerosolizing the liquid solution; and a nasal interface 2 comprising an exit orifice 6 for delivering the aerosolized solution as a jet of liquid washing/cleaning solution particles, such as a saline solution or the like, carried by compressed air.
  • a main body 4 comprising an electrically-driven compressor unit 5 (cf. Fig. 8 and 9 ) for providing compressed air
  • a reservoir 3 also called liquid tank member or liquid tank, for containing a liquid solution to be aerosolized, such as a saline solution, that is arranged above and coupled to the main body 4
  • the jet of aerosolized washing solution i.e. aerosol made of little dropelets of liquid
  • nebulization means 7 i.e. an aerosol-generating system, that blows the liquid solution into fine liquid particles thereby creating the desired jet of fine dropelets of liquid carried by the airflow.
  • nebulization means 7 are well-known as taught by EP-A-2732881 .
  • the nebulization means 7 are hereafter detailled.
  • the main body 4, the reservoir 3, the nebulization means 7 and the nasal interface 2 fit together in a removable or detachable way. In other words, that can be connected or disconnected one from the other upon user's wishes, for instance for cleaning purposes or the like.
  • the main body 4, the reservoir 3 and the nebulization means 7 are preferably made of polymer material, such as polycarbonate (PC) or the like.
  • the nasal washing device 1 of the present invention has an overall axially-elongated shape and projects upwardly. More precisely, it comprises a generally cylindrical or quasi-cylindrical section 42 corresponding to a part of the main body 4, and a tapered section 43 comprising the nasal interface 2 that is arranged above said generally (quasi) cylindrical portion 42, when the nasal washing device 1 is viewed in its upright position as shown in Figure 2 .
  • the (quasi) cylindrical section 42 is designed and sized for being handled in one hand by the user. It is arranged above an enlarged base 41 having a flat bottom 40, i.e. a flat underneath surface, so that the nasal washing device 1 can stand in an upright position when laying on a support, such as a table or the like.
  • the generally (quasi) cylindrical 42 and the enlarged base 41 of the main body 1 are preferably made integral.
  • the main body 4 can be made of two complementary half-shells or half-parts 4a, 4b coupled together as shown in Figure 8 .
  • Each of these half-shells 4a, 4b can be molded in one-piece.
  • the half-shells 4a, 4b are made of polymer material, such as polycarbonate (PC) or the like.
  • the main body 4 further comprises a collar 50 at its upper end.
  • the collar 50 can be part of 4b of the half-shells 4a, 4b as shown in Figure 8 .
  • the collar 50 participates in the fixing of the reservoir 3, as hereater explained.
  • the main body 4 comprises an electrically-driven compressor unit 5 (cf. Fig. 8 and 9 ) driven by electrically-driven compression means that are arranged into a protective casing 13.
  • the compression means comprise an electrically-driven motor,such as a 5V DC motor, cooperating with pumping means, such as a (or several) membrane or diaphragm pump, for compressing ambient air.
  • the motor and the pumping means are arranged into the protective casing 13.
  • the compressor unit 5 provides compressed-air at a maximum pressure of for instance 2 bar, typically of about 1 bar, and at a maximum flowrate of less than 10 L/min, preferably of 5 L/min or less. Compressed-air allows nebulizating the liquid solution in the nebulization means 7.
  • Ambient air to be compressed i.e. sucked by the compressor unit 5 enters into the casing 13 via an air inlet 14 and, once compressed, exits the casing 13 via a compressed-air outlet 15, as shown in Figure 8 .
  • the air inlet 14 and the compressed-air outlet 15, i.e. orifices or the like, are arranged on the top part 13a of the casing 13 of the compressor unit 5.
  • they can be carried by little conducts 140, 150 projecting away from the external upper surface 170 of the top part 13a of the casing 13 as shown in Figure 8 , preferably axially-arranged little conducts 140, 150.
  • These conducts 140, 150 cooperates with a damper member 8 as hereafter explained.
  • the reservoir 3 or liquid tank that contains the liquid solution to be aerosolized, comprises a cylindrical portion 31 arranged above an enlarged base portion 30.
  • the cylindrical portion 31 is made of a transparent material, such as a transparent polymer and comprises volume indicators or markings comprised between 0 and 20 ml, for instance 3 ml, 6 ml, 9 ml, 12 ml and 15 ml, for allowing the user to figure out the amount/quantity of liquid solution stored in the reservoir 3.
  • a transparent material such as a transparent polymer
  • volume indicators or markings comprised between 0 and 20 ml, for instance 3 ml, 6 ml, 9 ml, 12 ml and 15 ml, for allowing the user to figure out the amount/quantity of liquid solution stored in the reservoir 3.
  • the cylindrical portion 31 of the reservoir 3 further comprises an axial hollow conduct 34 arranged at the center of the cylindrical portion 31, that is fluidically connected, by its lower orifice (not shown), to the compressed-air outlet 15 of the casing 13, namely to the conduct 150 comprising said compressed-air outlet, for recovering and conveying compressed-air into its lumen. Compressed-air is subsequently delivered by the upper orifice 35 of said axial hollow conduct 34.
  • the enlarged base portion 30 of the reservoir 4 is configured for being coupled to the main body 4 by means of a suitable coupling system, such as a male/female coupling system.
  • a suitable coupling system such as a male/female coupling system.
  • the enlarged base portion 30 comprises one or several indentations 32 cooperating with protrusions 51 arranged on the collar 50 of the main body 4, or vice versa, so that when the protrusions 51 are lodged into the indentations 32, a firm coupling of the reservoir 3 to the main body 4 is ensured.
  • the reservoir 3 and the main body 4 are, in this embodiment, fitted together.
  • this coupling can achieved by, first, a translation motion T of the reservoir 3 toward the main body 4 until they abut one against the other as the enlarged base portion 30 of the reservoir 4 forms a sleeve around a collar 50 of the main body 4, and, second, a rotation R of the reservoir 3 (or of the main body 4) until the protrusions 51 enter into the indentations 32 thereby ensuring a perfect positioning of these parts.
  • a translation motion T of the reservoir 3 toward the main body 4 until they abut one against the other as the enlarged base portion 30 of the reservoir 4 forms a sleeve around a collar 50 of the main body 4, and, second, a rotation R of the reservoir 3 (or of the main body 4) until the protrusions 51 enter into the indentations 32 thereby ensuring a perfect positioning of these parts.
  • other equivalent coupling systems can be used, such as threaded or bayonet systems.
  • the nebulization means 7 for aerosolizing the liquid solution are mounted in the cylindrical portion 31 of the reservoir 3 as shown in Figures 4 and 7 , and are inserted into the inner hollow volume 24 of the nasal interface 2.
  • the washing liquid solution such as a saline solution, that is sucked out by the flow of pressurized air provided by the compressor unit 5.
  • the nebulization means 7 or aerosol-generating system comprise an elongated hollow element 71 traversed by an axial conduit 73 terminated by an outlet orifice 72 forming an inner nozzle, as shown in Figure 3 .
  • An ejector 74 is arranged in the lumen of the axial conduit 73 of the elongated hollow element 71.
  • the elongated hollow element 71 When the elongated hollow element 71 is positioned in the reservoir 3, the elongated hollow element 71 is co-axially inserted around the axial hollow conduit 34 arranged at the center of the cylindrical portion 31, i.e. forms a sleeve around said axial hollow conduct 34.
  • a suction effect i.e. a Venturi effect
  • a little annular spacing for instance of less than 5 mm, is maintained between the elongated hollow element 71 and the axial hollow conduit 34 that are coaxially-positioned.
  • Compressed-air is delivered by the upper orifice 35 of said axial hollow conduit 34 and travels toward the ejector 74.
  • the ejector 74 can be a flow restriction, such a calibrated orifice arranged in the lumen of the elongated hollow element 71.
  • the little spacing forms a tubular hollow column or gap through which the liquid solution sucked out of the reservoir can circulated toward the ejector 74, due to the suction force caused by the compressed airflow circulating in the axial hollow conduct 34 toward its upper orifice 35.
  • the sucked liquid and the compressed air enter into contact and start to mix together in the region of the lumen 73 located between the upper orifice 35 of the axial hollow conduct 34 and the ejector 74 elongated hollow element 71.
  • the liquid/compressed air mixture traverses the ejector 74, i.e. a flow restriction, which blows the liquid into fine liquid particles thereby creating the desired nebulized stream or mist of nebulized particles of liquid carried by the airflow, i.e. the desired aerosolized jet.
  • the ejector 74 i.e. a flow restriction
  • the thus obtained aerosolized jet then exists the elongated hollow element 71 by its outlet orifice 72 forming an inner nozzle, traverses inner chamber 22 and is subsequently delivered by the exit orifice 6 of the nasal interface 2 as a micronized liquid jet or the like, as explained below.
  • the nasal interface 2 is attached to the reservoir 3, preferably threaded to the reservoir 3.
  • the enlarged base portion 30 of the reservoir 4 also comprises a thread portion 33 that cooperates with a mutual thread portion carried by an inner wall (not visible) of the nasal interface 2.
  • the nasal interface 2 is arranged around the reservoir 4, namely the nasal interface 2 forms a sleeve encompassing and covering the entire cylindrical portion 31 of the reservoir 4 and the thread portion 33 carried by the enlarged base portion 30 of the reservoir 4, as illustrated in Figure 3 .
  • the nasal interface 2 further comprises a tapered portion 21 projecting upwardly, i.e. a conical or quasi-conical portion, and further a hollow inner volume 24, i.e. a lumen, for receiving the nebulization means 7 as shown in Figure 3 .
  • the hollow inner volume 24 further comprises an inner chamber 22 that is traversed by the aerosolized jet generated by the nebulization means 7 before it is delivered by the exit orifice 6 as a micronized liquid jet or the like.
  • the tapered portion 21 of the nasal interface 2 comprises a free end forming a nozzle portion, i.e. a nasal canula or nasal prong, comprising the exit orifice 6 for delivering the jet of nebulized solution.
  • the tapered portion 21 of the nasal interface 2 has a bell-shape. It constitutes a nebulization bell.
  • the inner chamber 22 of nasal interface 2 is located in the tapered portion 21, i.e. in the bell-shaped portion, as shown in Figure 3 .
  • the tapered portion 21, i.e. the bell-shaped section, is configured and sized for being at least partially inserted into a nostril of a paediatric user, such as a baby, toddler, infant or the like, for delivering the jet of saline solution of the like therein, thereby washing the nasal cavity(ies) and/or paranasal sinus(es) of said user.
  • the tapered portion 21 of the nasal interface 2 is made of resilient material, such as silicone or the like.
  • the "cleaning wastes" exiting the nostrils are preferably recovered by a waste-collecting chamber arranged on the nasal interface 2.
  • Said waste-collecting chamber is an outer annular chamber 23 coaxially-arranged as a sleeve or skirt and projecting updwardly around the hollow inner volume 24, i.e. the lumen, of the nasal interface 2, as shown in Figures 3 and 4
  • the outer annular chamber 23 and the hollow inner volume 24 are separated by inner wall 25 as shown in Figure 3 , whereas the waste-collecting chamber 23 comprises an outer annular wall 26.
  • the length of the outer annular wall 26 of the waste-collecting chamber 23 is shorter than the length of the the tapered portion 21 of the nasal interface 2 thereby allowing an easy insertion of the nozzle part of the tapered portion 21 of the nasal interface 2 into a nostril of a user.
  • the cleaning wastes flowing out of the nostril(s) are collected by gravity and stored into the waste-collecting chamber 23 that constitutes an open receptacle for the wastes, during the duration of the washing/cleaning.
  • the main body 4 also comprises a manual actuator 9 actuable by a user, comprising a push- or press-button, for controlling the delivery of electrical power to said compressor unit 5.
  • the manual actuator 9 actuator cooperates, directly or indirectly, with the compressor unit 5 for starting the nebulization of the liquid solution, upon activation of said manual actuator 9 by the user, thereby starting a nasal cleaning operation, or conversely, for stopping the nebulization of the liquid solution, upon release of said manual actuator 9 by the user, thereby stopping the nasal cleaning operation.
  • the manual actuator 9 when actuated by a user, the manual actuator 9 cooperates with a microprocessor and an electrical circuitry for providing electric current to the compressor unit 5,thereby starting the motor of the compressor unit 5 and initiating the nebulization proceedings.
  • the microprocessor is preferably arranged on an electronic board.
  • the electric current is provided by an electrical-power source as detailed hereafter, such as a rechargeable battery.
  • the microprocessor can be also used for controlling the charge of the rechargeable electrical-power source, i.e. managing the level of charge of a rechargeable battery or the like.
  • the main body 4 comprises an air entry 12, namely one or several holes, slots or the like, arranged in its peripheral (i.e. lateral) wall as shown in Figures 9 and 10 , preferably in the upper part of the peripheral wall of the main body 4, namely in the vicinity of the reservoir 3, for prodiving ambient air to the compression unit 5.
  • the air entry 12 does not comprise any valve element, such as an intake valve, i.e. the air entry is permanently in free communication with the ambient atmopshere.
  • the device 1 further comprises a damper member 8 that is arranged in the main body 4 so as to cover the top part 13a of the casing 13 of the compressor unit 5.
  • the damper member 8 is made of resilient material, such as silicone or the like, that is able to absorb at least a part of the vibrations of the compressor unit 5, during air compression. It has a generally cup-like shape, i.e. it comprises a bottom wall 80 having a disk-shape and an annular wall 81 attached to the periphery of the bottom wall 80 and projecting away from said bottom wall 80. Preferably, the disk-shape bottom 80 is flat.
  • the damper member 8 comprises an air passage 10, i.e. one or several conduit(s) or hole(s) traversing in the annular wall 81 of the damper member 8, as visible in Figures 9 and 10 .
  • the air inlet 14 of the casing 13 of the compressor unit 5 is in fluid communication with the air entry 12 of the main body 4, via the air passage 10 of the damper element 8, as detailled in Figure 10 .
  • the compressed-air outlet 15 of the casing 13, namely the conduit 150 comprising said compressed-air outlet 15, is arranged in a compressed-air passage 11 of the damper member 8, thereby improving the gas tightness downstream of the compression unit 5, namely in the region of the compressed-air outlet 15 of the casing 13.
  • the main body 1 further comprises an electrical-power source (not shown) that is electrically-connected to the compressor unit 5 for providing electrical power to said compressor unit 5 for operating it thereby delivering compressed air used for generating the jet of aerosolized liquid.
  • the electrical-power source preferably comprises a (or several) rechargeable battery, such as a rechargeable lithium battery, for instance a Lithium Polymer 3.7V 1650mAh battery, having a duration of at least 30 min, preferably of about 45 min or more, i.e. without being recharged.
  • a micro-USB socket 45 for plugging a micro-USB cable thereto, preferably a micro-USB cable comprising a power adapter for being connected to the electrical mains (e.g. 220 V).
  • the manual actuator 9 i.e. a push- or press-button, is automatically inactivated so that no electric current is provided to the compressor unit 5 for safety reasons.
  • a mobile cap 47 such as a pivotatable cap, is arranged in the vicinity of the micro-USB socket 45 so as to protect it, when not used.
  • the cap 47 is removed, e.g. pivotated, for freeing the micro-USB socket 45 thereby allowing the user to plug the micro-USB cable thereto, when a battery charge has to be done.
  • LEDs 46 such as a row of 3 LEDs emitting a colored light (e.g. blue, red, yellow, orange, green...), for monitoring the state of charge of the battery(ies).
  • a colored light e.g. blue, red, yellow, orange, green
  • the LEDs 47 are off. The charge is partial when only 1 or 2 LEDs 46 are lit. While charging, the LEDs 46 flash.
  • the (micro-)USB socket 45, the mobile cap 47 and the LEDs 46 are arranged in the enlarged base 41 of the main body 4.
  • the nasal washing device 1 of the invention can have a weight of less than 350 g, for instance of about 200 to 280 g, measured when empty, i.e. without liquid solution in the reservoir 3. It can have for instance the following dimensions : 21 cm x 6 cm x 10 cm.
  • the nasal washing device 1 of the invention has been tested with a saline solution of NaCI (0.9%) and measurements have been made according to the European Standard UNI EN 13544-1. The results are given in the following Table.
  • Table Minimum filling volume of the reservoir 3 ml Maximum filling volume of the reservoir 15 ml Aerosol output 13 ml Aerosol output rate 10 ml/min MMAD (*) 49 ⁇ m Air pressure delivered compressor unit 1 bar Air flow delivered compressor unit 5 L/min Noise level 58 dbA Vibrations Very attenuated (*) : MMAD is the median mass aerodynamic diameter of the aerosol droplets.
  • the noise level is low and the vibrations are minimum.
  • a nasal washing device 1 according to the present invention is particularly adapted for washing the nasal cavities and/or paranasal sinuses of a paediatric person, such as a baby, a toddler or an infant.

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  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
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  • Devices For Medical Bathing And Washing (AREA)

Abstract

The present invention concerns a nasal washing device (1) comprising a main body (4) comprising an electrically-driven compressor unit (5), a reservoir (3) for containing a liquid solution to be aerosolized, nebulization means (7) for aerosolizing the liquid solution, and a nasal interface (2) comprising an exit orifice (6) for delivering an aerosolized solution. It is further provided a damper member (8) arranged in the main body (4), said damper member (8) covering at least a part of the compressor unit (5). The damper member (8) is made of resilient material, such as silicone or the like. Thanks to the invention, it is possible to minimize the noise and to attenuate the vibrations resulting from the operation of the compressor unit (5). The invention further concerns a nasal cleaning set comprising a transport bag containing a nasal washing device (1) according to the invention and, preferably instructions for use

Description

  • The present invention concerns a nasal washing/cleaning device for delivering a liquid solution jet, e.g. a washing/cleaning solution, such as a saline solution or the like, to the nasal cavities and/or paranasal sinuses of a user or person, especially pediatric users, such as babies, toddlers, infants or the like, thereby washing, cleaning, promoting hydration and fluidification, and allowing removal of mucus and phlegm, or the like, from the nasal areas.
  • Nasal washing devices are used for delivering a nebulized or atomized liquid solution, such as saline solutions or the like, to the nasal cavities of a person.
  • The nebulized solution contributes to the removal of excessive mucus, i.e. catarrh, present in the nasal cavities and/or paranasal sinuses of the person, thereby preparing the nasal cavities and/or paranasal sinuses for, for instance, subsequent administrations of one or several therapeutic agents, drugs or the like.
  • Without such a "pre"-washing or "pre-"cleaning, the drugs or therapeutic agents that are subsequently intra-nasally administrated, cannot act properly as they are stopped by the mucus and hence unable to reach the nasal areas, where they are supposed to act and/or to enter into the blood circulation of the person.
  • Nasal washing devices can be used with persons suffering from various diseases, such as rhinopharyngitis, allergic rhinitis or chronic sinusitis, and subsequently treated by antihistaminic agents, antibiotics or decongestants that are intra-nasally delivered.
  • Examples of nasal washing devices are disclosed by EP-A-2732881 and EP-A-2274033 .
  • EP-A-2732881 dislcoses a nasal washing device comprising a main body, a reservoir for containing a liquid solution to be aerosolized, nebulization means for aerosolizing the liquid solution, and a nasal interface with an exit orifice for delivering the aerosolized solution used for cleaning the nasal cavities of a user. The aerosolization, i.e. atomization, of the liquid solution is obtained thanks to compressed air provided by an external compressor device that is fluidly connected to the nasal washing device by means of a flexible hose, as shown in Figure 1.
  • EP-A-2274033 proposes a nasal washing device that is similar to the previous one except that it comprises an internal compressor unit and batteries for powering it and generating a flow of compressed air, in lieu of an external compressor device. The air passage that provides ambient air to the compressor unit is located under the device, i.e. in its base, and requires a intake valve.
  • If such a nasal washing device provides a simplier architecture thanks to the incorporation of the compressor unit into the device, the need for an intake valve adds a different element of complexity to it.
  • More generally speaking, with such a device including an internal compressor unit, it has been noticed that some vibrations often appear when the compressor unit works, i.e. generates compressed air, which are unpleasant for the user that has to handle the device, i.e. to hold it in one hand while using it.
  • Further, compressed-air leaks also may appear at the exit of the compressor unit that may impact the efficiency of nebulization/atomization of the liquid solution.
  • Hence, it is an objective of the present invention to try to overcome at least a part of the above problems in providing an improved nasal washing device, especially an nasal washing device wherein the vibrations are eliminated or minimized and/or wherein the gas tightness is improved and/or wherein the air passage does not require any intake valve.
  • A solution according to the present invention is a nasal washing device, preferably a portable device, comprising:
    • a main body, i.e. a housing, comprising an electrically-driven compressor unit,
    • a reservoir for containing a liquid solution to be aerosolized,
    • nebulization means for aerosolizing the liquid solution,
    • a nasal interface comprising an exit orifice for delivering an aerosolized solution, especially a micronized solution jet,
    characterized in that it further comprises a damper member arranged in the main body, said damper member covering at least a part of the compressor unit.
  • A nasal washing device according to the present invention can comprise one or several of the following additional features :
    • the damper member is made of resilient material, such as silicone or the like, that is able to absorb and attenuate vibrations.
    • the damper member has a generally cup-like shape.
    • the damper member has a cup-like shape comprising a bottom wall and an annular wall attached to the periphery of the bottom wall and projecting away from said bottom wall.
    • the damper member has a cup-like shape comprising a bottom wall having a disk-shape, preferably the disk-shape bottom is flat.
    • the damper member comprises an air passage, such as one or several little conducts.
    • the air passage is arranged in the annular wall of the damper member, i.e. the air passage traverses said annular wall.
    • the main body comprises an air entry.
    • the air entry of the main body comprises one or several holes, slots or the like.
    • the air entry is arranged in the peripheral (i.e. lateral) wall of the main body.
    • the air entry is arranged laterally in the upper part of the peripheral wall of said main body, i.e. in the vicinity of the reservoir.
    • the air entry of the main body is in fluid communication with the air passage of the damper member so that ambient air can pass successively through the air entry of the main body and the air passage of the damper member.
    • the air entry does not comprise any valve element, such as an intake valve, i.e. the air entry is permanently in free communication with the ambient atmopshere.
    • the compressor unit comprises a protective casing, i.e. a rigid housing, containing compression means, said casing further comprising an air inlet for providing ambient air (i.e. non-compressed air) and a compressed air-outlet for delivering compressed-air.
    • compression means are configured for compressing ambient air to a pressure above atmospheric pressure, for instance a maximum pressure of one or several bar above atm. pressure.
    • the compressor unit provides compressed-air at a maximum pressure of 2 bar, preferably a maximum pressure of 1.5 bar, typically of about 1 bar.
    • the compressor unit provides compressed-air at a maximum flowrate of less than 10 L/min, preferably 5 L/min or less.
    • compression means comprise an electrically-driven motor, preferably a direct current (DC) motor, for instance a 5 V motor.
    • compression means further comprise pumping means, such as a membrane or diaphragm pump.
    • the electrically-driven motor cooperates with the pumping means for compressing air.
    • the electrically-driven motor and the pumping means are arranged into the casing.
    • the casing is made of a rigid material, such as a polymeric or metallic material.
    • the damper member is arranged only on the top part of the casing of the compressor unit, i.e. it does not cover the whole casing.
    • the damper member is sandwiched between the outer end surface of the top part of the casing of the compressor unit and an inner wall of the main body.
    • the damper member has a cup-like shape comprising an inner shape matching the outer shape of the top part of the casing of the compressor unit, preferably the outer end surface and an adjacent portion of the peripheral wall of the top part of the casing.
    • the air inlet of the casing of the compressor unit is in fluid communication with the air entry of the main body, via the air passage of the damper element.
    • the compressed-air outlet of the casing is arranged in a compressed-air passage of the damper member.
    • the main body further comprises an electrical-power source, arranged in said main body, electrically-connected to the compressor unit for providing electrical power to said compressor unit for operating said compressor unit, namely the compression means, thereby delivering compressed air.
    • the electrical-power source is rechargeable.
    • the electrical-power source comprises one or several batteries or the like, preferaby rechargeable batterie(s).
    • the electrical-power source comprises a rechargeable lithium battery, such as a Lithium Polymer 3.7V 1650mAh battery.
    • the battery has a duration of at least 30 min, preferably of about 45 min or more, i.e. without being recharged.
    • the nebulization means comprise an elongated hollow element traversed by an axial conduct terminated by an outlet orifice forming an inner nozzle.
    • the axial conduct of the elongated hollow element comprises an ejector arranged in its lumen.
    • the main body further comprises a manual actuator actuable by a user for controlling the delivery of electrical power to said compressor unit.
    • the manual actuator comprises a push- or press-button, or the like.
    • the manual actuator cooperates, directly or indirectly, with the compressor unit for starting the nebulization of the liquid solution, upon activation of said manual actuator by a user, thereby starting the nasal cleaning operation.
    • the manual actuator cooperates, directly or indirectly, with the compressor unit for stopping the nebulization of the liquid solution, upon release of said manual actuator by a user, thereby stopping the nasal cleaning operation.
    • the nasal interface comprises an inner chamber traversed by the aerosolized solution generated by nebulization means before it is delivered by the exit orifice as a micronized liquid jet or the like.
    • the nasal interface comprises an outer annular chamber forming a waste-recovering chamber, having an open annular end for recovering the wastes resulting from the nasal cavity washing or cleaning operation, such as liquid/mucus mixtures or the like .
    • the outer annular chamber forms a sleeve or skirt and projects upwardly around the inner volume (i.e. lumen) of the nasal interface.
    • the reservoir, i.e. liquid tank, is attached to the main body.
    • the reservoir contains a washing or cleaning liquid solution, i.e. a non therapeutically-active solution, such as a saline solution, a hypertonic solution or thermal water.
    • the reservoir contains a washing or cleaning liquid solution containing a therapeutically-active compound, i.e. a drug or the like.
    • the reservoir comprises a cylindrical (i.e. tubular) portion arranged above an enlarged base portion.
    • the cylindrical portion of the reservoir is made of a transparent material, such as a transparent polymer.
    • the cylindrical portion of the reservoir comprises volume indicators or markings comprised between 0 and 20 ml, for instance 3 ml, 6 ml, 9 ml, 12 ml and 15 ml.
    • the cylindrical portion of the reservoir comprises an axial hollow conduct arranged at the center of said cylindrical portion.
    • the elongated hollow element is positioned in the reservoir.
    • the elongated hollow element is co-axially inserted, i.e. as a sleeve, around the axial hollow conduct arranged at the center of the cylindrical portion of the reservoir.
    • an annular spacing is provided between the elongated hollow element and the axial hollow conduct when co-axially arranged.
    • the enlarged base portion of the reservoir and the main body comprise a coupling system for attaching the reservoir to the main body, such as a male/female coupling system.
    • the nasal interface is attached to the reservoir.
    • the nasal interface is arranged around the reservoir, i.e. the nasal interface forms a sleeve encompassing (i.e. covering) the reservoir.
    • the nasal interface comprises a tapered portion projecting upwardly.
    • the tapered portion of the the nasal interface comprises a conical or quasi-conical portion.
    • the tapered portion of the the nasal interface is configured and sized for being inserted into a nostril of a user, in particular of a baby, toddler, infant or the like.
    • the tapered portion of the the nasal interface forms a nozzle portion configured and sized for being at least partially inserted into a nostril of a user.
    • the tapered portion of the nasal interface comprises a free end forming a nozzle portion, i.e. a nasal canula or nasal prong, having a bell shape or the like. It is also called a nebulization bell.
    • the nozzle portion having a bell shape, i.e. the nebulization bell, is made of resilient material, such as silicone or the like.
    • the exit orifice is arranged at the free end of the tapered portion of the nasal interface.
    • the nasal washing device has a generally ellongated shape, preferably an axially-ellongated shape.
    • the main body comprises a generally-cylindrical or quasi-cylindrical section designed and sized for being handled in one hand by the user.
    • the main body further comprises an enlarged base having a flat bottom (i.e. an underneath flat surface) so that the nasal washing device can stand in an upright position when laying on a support, such as a table or the like.
    • the generally (quasi) cylindrical section of the main body is arranged, i.e. located, above the enlarged base.
    • the generally (quasi) cylindrical and the enlarged base section of the main body are made integral.
    • the main body is made of two sub-parts, i.e. complementary half shells, coupled together.
    • the main body (i.e. two haf-shells), the reservoir and the nebulization means are made of polymer material, such as polycarbonate (PC) or the like.
    • the main body further comprises a (micro-)USB socket for plugging a (micro-)USB cable thereto useable for recharging the battery(ies), preferably a (micro-)USB cable and a power adapter.
    • the main body further comprises a mobile cap, such as a pivotatable cap, arranged so as to protect the (micro-)USB socket, when not used. The cap is removed (e.g. pivotated) for freeing the micro-)USB socket and allowing the user to plug a (micro-)USB cable thereto, when a battery charge has to be done.
    • the main body further comprises one or several LEDs, such as a row of 3 LEDs emitting a light of a same or of different colors (e.g. blue, red, yellow, orange, green...), for indicating the state of charge of the electrical-power source, e.g. the state of charge of rechargeable battery(ies). When all the LEDs are lit, the battery charge is completed, i.e. battery fully charged. Conversely, when the battery charge is totally discharged, the LEDs are off.
    • the (micro-)USB socket, the mobile cap and the LEDs are arranged in the enlarged base of the main body.
    • the device has a weight of less than 350 g, preferably less than 300 g, for instance of about 200 to 280 g (mesured when empty, i.e. without liquid solution in the reservoir).
    • the device can have for instance the following dimensions 21 cm x 6 cm x 10 cm.
    • when operated, the device exhibits a noise level of less than 60 dbA.
  • The invention also concerns an nasal cleaning set or assembly comprising a transport bag containing a nasal washing device according to the present invention, preferably it further comprises instructions for use, such as a user's guide or the like.
  • According to another aspect, the invention also concerns the use of a nasal washing assembly according to the invention, e.g. as above described, for washing the nasal cavities and/or paranasal sinuses of a paediatric person, such as a baby, a toddler or an infant, with a non therapeutically-active solution chosen among a saline solution, a hypertonic solution or thermal water.
  • The present invention will be explained in more details in the following illustrative description of an embodiment of a nasal washing/cleaning device according to the present invention, which is made in references to the accompanying drawings among them :
    • Figure 1 shows a nasal washing device according to the prior art,
    • Figure 2 is a side view of an embodiment of a nasal washing device according to the present invention,
    • Figure 3 is a sectional view showing the nasal interface and the reservoir of the nasal washing device according to the present invention,
    • Figure 4 is an exploded view of the nasal washing device of Figure 1,
    • Figure 5 illustrates the mounting of the reservoir on the main body of the nasal washing device of Figures 1 and 2,
    • Figure 6 shows the base of the main body of the nasal washing device of Figures 1 and 2,
    • Figure 7 illustrates the mounting of the nebulization means in the reservoir of the nasal washing device of Figures 1 and 2,
    • Figure 8 is an exploded view of the main body of the nasal washing device of Figures 1 and 2,
    • Figure 9 is a sectional view of the main body of the nasal washing device of Figures 1 and 2, and
    • Figure 10 is an enlarged view of the circled part of Figure 9.
  • Figure 1 shows a nasal washing device 111 as taught by EP-A-2732881 . It comprises a main body 114, a reservoir (not visible) for containing a liquid solution to be aerosolized, nebulization means (not visible) for aerosolizing the liquid solution, and a nasal interface 112 with an exit orifice 115 for delivering the aerosolized solution for cleaning the nasal cavities of a user. Compressed air is provided by an external compressor device 116, i.e. an independant compressed-air generator, that is fluidly connected to the nasal washing device 111 by means of a flexible hose 117 that is plugged to a connector 113 of the main body 114.
  • Figures 2 and 4 show an embodiment of a nasal washing device 1 according to the present invention, preferably a portable device, that is configured for delivering a jet of aerosolized or nebulized solution, also called mist or aerosol, into the nasal cavities, i.e. nostrils, of a person for washing said nasal cavities and/or paranasal sinuses.
  • The nasal washing device 1 comprises, as shown in Figures 2 and 4, a main body 4 comprising an electrically-driven compressor unit 5 (cf. Fig. 8 and 9) for providing compressed air; a reservoir 3, also called liquid tank member or liquid tank, for containing a liquid solution to be aerosolized, such as a saline solution, that is arranged above and coupled to the main body 4; nebulization means 7 for aerosolizing the liquid solution; and a nasal interface 2 comprising an exit orifice 6 for delivering the aerosolized solution as a jet of liquid washing/cleaning solution particles, such as a saline solution or the like, carried by compressed air.
  • The jet of aerosolized washing solution, i.e. aerosol made of little dropelets of liquid, is generated in the nasal washing device 1 by nebulization means 7, i.e. an aerosol-generating system, that blows the liquid solution into fine liquid particles thereby creating the desired jet of fine dropelets of liquid carried by the airflow. Such nebulization means are well-known as taught by EP-A-2732881 . The nebulization means 7 are hereafter detailled.
  • The main body 4, the reservoir 3, the nebulization means 7 and the nasal interface 2 fit together in a removable or detachable way. In other words, that can be connected or disconnected one from the other upon user's wishes, for instance for cleaning purposes or the like. The main body 4, the reservoir 3 and the nebulization means 7 are preferably made of polymer material, such as polycarbonate (PC) or the like.
  • As illustrated in Figure 2, the nasal washing device 1 of the present invention has an overall axially-elongated shape and projects upwardly. More precisely, it comprises a generally cylindrical or quasi-cylindrical section 42 corresponding to a part of the main body 4, and a tapered section 43 comprising the nasal interface 2 that is arranged above said generally (quasi) cylindrical portion 42, when the nasal washing device 1 is viewed in its upright position as shown in Figure 2.
  • The (quasi) cylindrical section 42 is designed and sized for being handled in one hand by the user. It is arranged above an enlarged base 41 having a flat bottom 40, i.e. a flat underneath surface, so that the nasal washing device 1 can stand in an upright position when laying on a support, such as a table or the like.
  • The generally (quasi) cylindrical 42 and the enlarged base 41 of the main body 1 are preferably made integral.
  • For instance, the main body 4 can be made of two complementary half-shells or half- parts 4a, 4b coupled together as shown in Figure 8. Each of these half- shells 4a, 4b can be molded in one-piece. Preferably, the half- shells 4a, 4b are made of polymer material, such as polycarbonate (PC) or the like.
  • The main body 4 further comprises a collar 50 at its upper end. The collar 50 can be part of 4b of the half- shells 4a, 4b as shown in Figure 8. The collar 50 participates in the fixing of the reservoir 3, as hereater explained.
  • Further, the main body 4 comprises an electrically-driven compressor unit 5 (cf. Fig. 8 and 9) driven by electrically-driven compression means that are arranged into a protective casing 13. Preferably, the compression means comprise an electrically-driven motor,such as a 5V DC motor, cooperating with pumping means, such as a (or several) membrane or diaphragm pump, for compressing ambient air. The motor and the pumping means are arranged into the protective casing 13.
  • The compressor unit 5 provides compressed-air at a maximum pressure of for instance 2 bar, typically of about 1 bar, and at a maximum flowrate of less than 10 L/min, preferably of 5 L/min or less. Compressed-air allows nebulizating the liquid solution in the nebulization means 7.
  • Ambient air to be compressed, i.e. sucked by the compressor unit 5, enters into the casing 13 via an air inlet 14 and, once compressed, exits the casing 13 via a compressed-air outlet 15, as shown in Figure 8.
  • Preferably, the air inlet 14 and the compressed-air outlet 15, i.e. orifices or the like, are arranged on the top part 13a of the casing 13 of the compressor unit 5. For instance, they can be carried by little conducts 140, 150 projecting away from the external upper surface 170 of the top part 13a of the casing 13 as shown in Figure 8, preferably axially-arranged little conducts 140, 150. These conducts 140, 150 cooperates with a damper member 8 as hereafter explained.
  • As shown in Figure 4, the reservoir 3 or liquid tank, that contains the liquid solution to be aerosolized, comprises a cylindrical portion 31 arranged above an enlarged base portion 30.
  • The cylindrical portion 31 is made of a transparent material, such as a transparent polymer and comprises volume indicators or markings comprised between 0 and 20 ml, for instance 3 ml, 6 ml, 9 ml, 12 ml and 15 ml, for allowing the user to figure out the amount/quantity of liquid solution stored in the reservoir 3.
  • The cylindrical portion 31 of the reservoir 3 further comprises an axial hollow conduct 34 arranged at the center of the cylindrical portion 31, that is fluidically connected, by its lower orifice (not shown), to the compressed-air outlet 15 of the casing 13, namely to the conduct 150 comprising said compressed-air outlet, for recovering and conveying compressed-air into its lumen. Compressed-air is subsequently delivered by the upper orifice 35 of said axial hollow conduct 34.
  • The enlarged base portion 30 of the reservoir 4 is configured for being coupled to the main body 4 by means of a suitable coupling system, such as a male/female coupling system. For instance, the enlarged base portion 30 comprises one or several indentations 32 cooperating with protrusions 51 arranged on the collar 50 of the main body 4, or vice versa, so that when the protrusions 51 are lodged into the indentations 32, a firm coupling of the reservoir 3 to the main body 4 is ensured. In other words, the reservoir 3 and the main body 4 are, in this embodiment, fitted together.
  • As illustrated in Figure 5, this coupling can achieved by, first, a translation motion T of the reservoir 3 toward the main body 4 until they abut one against the other as the enlarged base portion 30 of the reservoir 4 forms a sleeve around a collar 50 of the main body 4, and, second, a rotation R of the reservoir 3 (or of the main body 4) until the protrusions 51 enter into the indentations 32 thereby ensuring a perfect positioning of these parts. Of course, other equivalent coupling systems can be used, such as threaded or bayonet systems.
  • The nebulization means 7 for aerosolizing the liquid solution, are mounted in the cylindrical portion 31 of the reservoir 3 as shown in Figures 4 and 7, and are inserted into the inner hollow volume 24 of the nasal interface 2. The washing liquid solution, such as a saline solution, that is sucked out by the flow of pressurized air provided by the compressor unit 5.
  • More precisely, the nebulization means 7 or aerosol-generating system, comprise an elongated hollow element 71 traversed by an axial conduit 73 terminated by an outlet orifice 72 forming an inner nozzle, as shown in Figure 3.
  • An ejector 74 is arranged in the lumen of the axial conduit 73 of the elongated hollow element 71.
  • When the elongated hollow element 71 is positioned in the reservoir 3, the elongated hollow element 71 is co-axially inserted around the axial hollow conduit 34 arranged at the center of the cylindrical portion 31, i.e. forms a sleeve around said axial hollow conduct 34.
  • In order to obtain a suction effect, i.e. a Venturi effect, allowing the liquid solution present in the reservoir 3 to be sucked out of it and aerosolized, a little annular spacing, for instance of less than 5 mm, is maintained between the elongated hollow element 71 and the axial hollow conduit 34 that are coaxially-positioned.
  • Compressed-air is delivered by the upper orifice 35 of said axial hollow conduit 34 and travels toward the ejector 74. The ejector 74 can be a flow restriction, such a calibrated orifice arranged in the lumen of the elongated hollow element 71.
  • The little spacing forms a tubular hollow column or gap through which the liquid solution sucked out of the reservoir can circulated toward the ejector 74, due to the suction force caused by the compressed airflow circulating in the axial hollow conduct 34 toward its upper orifice 35.
  • Indeed, the pressure of compressed air traversing the upper orifice 35 suddently decreases thereby creating a pressure drop, and said pressure drop produces a suction force, i.e. a depressurization, that sucks the liquid solution out of the reservoir 3, along the annular spacing.
  • The sucked liquid and the compressed air enter into contact and start to mix together in the region of the lumen 73 located between the upper orifice 35 of the axial hollow conduct 34 and the ejector 74 elongated hollow element 71.
  • Then, the liquid/compressed air mixture traverses the ejector 74, i.e. a flow restriction, which blows the liquid into fine liquid particles thereby creating the desired nebulized stream or mist of nebulized particles of liquid carried by the airflow, i.e. the desired aerosolized jet.
  • The thus obtained aerosolized jet then exists the elongated hollow element 71 by its outlet orifice 72 forming an inner nozzle, traverses inner chamber 22 and is subsequently delivered by the exit orifice 6 of the nasal interface 2 as a micronized liquid jet or the like, as explained below.
  • Furthermore, the nasal interface 2 is attached to the reservoir 3, preferably threaded to the reservoir 3. To this end, the enlarged base portion 30 of the reservoir 4 also comprises a thread portion 33 that cooperates with a mutual thread portion carried by an inner wall (not visible) of the nasal interface 2. When coupled, the nasal interface 2 is arranged around the reservoir 4, namely the nasal interface 2 forms a sleeve encompassing and covering the entire cylindrical portion 31 of the reservoir 4 and the thread portion 33 carried by the enlarged base portion 30 of the reservoir 4, as illustrated in Figure 3.
  • The nasal interface 2 further comprises a tapered portion 21 projecting upwardly, i.e. a conical or quasi-conical portion, and further a hollow inner volume 24, i.e. a lumen, for receiving the nebulization means 7 as shown in Figure 3. The hollow inner volume 24 further comprises an inner chamber 22 that is traversed by the aerosolized jet generated by the nebulization means 7 before it is delivered by the exit orifice 6 as a micronized liquid jet or the like.
  • More precisely, the tapered portion 21 of the nasal interface 2 comprises a free end forming a nozzle portion, i.e. a nasal canula or nasal prong, comprising the exit orifice 6 for delivering the jet of nebulized solution. The tapered portion 21 of the nasal interface 2 has a bell-shape. It constitutes a nebulization bell. The inner chamber 22 of nasal interface 2 is located in the tapered portion 21, i.e. in the bell-shaped portion, as shown in Figure 3.
  • The tapered portion 21, i.e. the bell-shaped section, is configured and sized for being at least partially inserted into a nostril of a paediatric user, such as a baby, toddler, infant or the like, for delivering the jet of saline solution of the like therein, thereby washing the nasal cavity(ies) and/or paranasal sinus(es) of said user.
  • Preferably, the tapered portion 21 of the nasal interface 2 is made of resilient material, such as silicone or the like.
  • Further, the "cleaning wastes" exiting the nostrils, e.g. a mixture of mucus and liquid solution, are preferably recovered by a waste-collecting chamber arranged on the nasal interface 2. Said waste-collecting chamber is an outer annular chamber 23 coaxially-arranged as a sleeve or skirt and projecting updwardly around the hollow inner volume 24, i.e. the lumen, of the nasal interface 2, as shown in Figures 3 and 4
  • The outer annular chamber 23 and the hollow inner volume 24 are separated by inner wall 25 as shown in Figure 3, whereas the waste-collecting chamber 23 comprises an outer annular wall 26. The length of the outer annular wall 26 of the waste-collecting chamber 23 is shorter than the length of the the tapered portion 21 of the nasal interface 2 thereby allowing an easy insertion of the nozzle part of the tapered portion 21 of the nasal interface 2 into a nostril of a user.
  • The cleaning wastes flowing out of the nostril(s) are collected by gravity and stored into the waste-collecting chamber 23 that constitutes an open receptacle for the wastes, during the duration of the washing/cleaning.
  • Further, the main body 4 also comprises a manual actuator 9 actuable by a user, comprising a push- or press-button, for controlling the delivery of electrical power to said compressor unit 5. The manual actuator 9 actuator cooperates, directly or indirectly, with the compressor unit 5 for starting the nebulization of the liquid solution, upon activation of said manual actuator 9 by the user, thereby starting a nasal cleaning operation, or conversely, for stopping the nebulization of the liquid solution, upon release of said manual actuator 9 by the user, thereby stopping the nasal cleaning operation.
  • For instance, when actuated by a user, the manual actuator 9 cooperates with a microprocessor and an electrical circuitry for providing electric current to the compressor unit 5,thereby starting the motor of the compressor unit 5 and initiating the nebulization processus. The microprocessor is preferably arranged on an electronic board. The electric current is provided by an electrical-power source as detailed hereafter, such as a rechargeable battery. The microprocessor can be also used for controlling the charge of the rechargeable electrical-power source, i.e. managing the level of charge of a rechargeable battery or the like.
  • Further, the main body 4 comprises an air entry 12, namely one or several holes, slots or the like, arranged in its peripheral (i.e. lateral) wall as shown in Figures 9 and 10, preferably in the upper part of the peripheral wall of the main body 4, namely in the vicinity of the reservoir 3, for prodiving ambient air to the compression unit 5. The air entry 12 does not comprise any valve element, such as an intake valve, i.e. the air entry is permanently in free communication with the ambient atmopshere.
  • According to the present invention, as shown in Figures 8 and 9, the device 1 further comprises a damper member 8 that is arranged in the main body 4 so as to cover the top part 13a of the casing 13 of the compressor unit 5.
  • The damper member 8 is made of resilient material, such as silicone or the like, that is able to absorb at least a part of the vibrations of the compressor unit 5, during air compression. It has a generally cup-like shape, i.e. it comprises a bottom wall 80 having a disk-shape and an annular wall 81 attached to the periphery of the bottom wall 80 and projecting away from said bottom wall 80. Preferably, the disk-shape bottom 80 is flat.
  • Further, the damper member 8 comprises an air passage 10, i.e. one or several conduit(s) or hole(s) traversing in the annular wall 81 of the damper member 8, as visible in Figures 9 and 10.
  • More precisely, the air inlet 14 of the casing 13 of the compressor unit 5 is in fluid communication with the air entry 12 of the main body 4, via the air passage 10 of the damper element 8, as detailled in Figure 10.
  • Further, the compressed-air outlet 15 of the casing 13, namely the conduit 150 comprising said compressed-air outlet 15, is arranged in a compressed-air passage 11 of the damper member 8, thereby improving the gas tightness downstream of the compression unit 5, namely in the region of the compressed-air outlet 15 of the casing 13.
  • Thanks to the arrangement of a damper member 8 in the main body 4 that covers the top 13a of the casing 13 of the compressor unit 5, it is possible to minimize the noise and attenuate the vibrations resulting from the operation of the compressor unit 5 as said compressor unit 5 is better maintained in the main body 4, i.e. in a still position.
  • Further, as already mentioned, the main body 1 further comprises an electrical-power source (not shown) that is electrically-connected to the compressor unit 5 for providing electrical power to said compressor unit 5 for operating it thereby delivering compressed air used for generating the jet of aerosolized liquid. The electrical-power source preferably comprises a (or several) rechargeable battery, such as a rechargeable lithium battery, for instance a Lithium Polymer 3.7V 1650mAh battery, having a duration of at least 30 min, preferably of about 45 min or more, i.e. without being recharged.
  • For charging the battery, it is provided in the main body 4, as shown in Figure 6, a micro-USB socket 45 for plugging a micro-USB cable thereto, preferably a micro-USB cable comprising a power adapter for being connected to the electrical mains (e.g. 220 V).
  • When a micro-USB cable is plugged into the micro-USB socket 45 and a charge is under way, the manual actuator 9, i.e. a push- or press-button, is automatically inactivated so that no electric current is provided to the compressor unit 5 for safety reasons.
  • A mobile cap 47, such as a pivotatable cap, is arranged in the vicinity of the micro-USB socket 45 so as to protect it, when not used. The cap 47 is removed, e.g. pivotated, for freeing the micro-USB socket 45 thereby allowing the user to plug the micro-USB cable thereto, when a battery charge has to be done.
  • It is also provided several LEDs 46, as shown in Figure 6, such as a row of 3 LEDs emitting a colored light (e.g. blue, red, yellow, orange, green...), for monitoring the state of charge of the battery(ies). When all the LEDs 46 are lit, the battery charge is completed, i.e. battery fully charged. Conversely, when the battery charge is totally discharged, the LEDs 47 are off. The charge is partial when only 1 or 2 LEDs 46 are lit. While charging, the LEDs 46 flash.
  • As shown in Figure the (micro-)USB socket 45, the mobile cap 47 and the LEDs 46 are arranged in the enlarged base 41 of the main body 4.
  • As an example, the nasal washing device 1 of the invention can have a weight of less than 350 g, for instance of about 200 to 280 g, measured when empty, i.e. without liquid solution in the reservoir 3. It can have for instance the following dimensions : 21 cm x 6 cm x 10 cm.
  • The nasal washing device 1 of the invention has been tested with a saline solution of NaCI (0.9%) and measurements have been made according to the European Standard UNI EN 13544-1. The results are given in the following Table. Table
    Minimum filling volume of the reservoir 3 ml
    Maximum filling volume of the reservoir 15 ml
    Aerosol output
    13 ml
    Aerosol output rate 10 ml/min
    MMAD (*) 49 µm
    Air pressure delivered compressor unit 1 bar
    Air flow delivered compressor unit 5 L/min
    Noise level 58 dbA
    Vibrations Very attenuated
    (*) : MMAD is the median mass aerodynamic diameter of the aerosol droplets.
  • As one can see, the noise level is low and the vibrations are minimum.
  • A nasal washing device 1 according to the present invention is particularly adapted for washing the nasal cavities and/or paranasal sinuses of a paediatric person, such as a baby, a toddler or an infant.

Claims (15)

  1. Nasal washing device (1) comprising :
    - a main body (4) comprising an electrically-driven compressor unit (5),
    - a reservoir (3) for containing a liquid solution to be aerosolized,
    - nebulization means (7) for aerosolizing the liquid solution, and
    - a nasal interface (2) comprising an exit orifice (6) for delivering an aerosolized solution,
    characterized in that it further comprises a damper member (8) arranged in the main body (4), said damper member (8) covering at least a part of the compressor unit (5).
  2. Nasal washing device according to the preceding claim, characterized in that the damper member (8) is made of resilient material.
  3. Nasal washing device according to the preceding claim, characterized in that the damper member (8) comprises an air passage (10) and the main body (4) comprises an air entry (12), said air entry (12) of the main body (4) being in fluid communication with the air passage (10) of the damper member (8).
  4. Nasal washing device according to the preceding claim, characterized in that the damper member (8) has a cup-like shape comprising a bottom wall (80) and an annular wall (81) attached to the periphery of the bottom wall (8) and projecting away from said bottom wall (8), preferably the bottom wall (80) having a disk-shape.
  5. Nasal washing device according to the preceding claim, characterized in that the damper member (8) comprises an air passage (10) arranged in the annular wall (81).
  6. Nasal washing device according to the preceding claim, characterized in that the compressor unit (5) comprises a casing (13) containing the electrically-driven compression means, said casing (13) further comprising an air inlet (14) and a compressed-air outlet (15).
  7. Nasal washing device according to the preceding claim, characterized in that the air inlet (14) of the casing (13) of the compressor unit (5) is in fluid communication with the air entry (12) of the main body (4), via the air passage (10) of the damper element (8).
  8. Nasal washing device according to the preceding claim, characterized in that the main body (4) comprises an air entry (12) arranged in the peripheral wall of said main body (4).
  9. Nasal washing device according to the preceding claim, characterized in that the compressed-air outlet (15) of the casing (13) of the compressor unit (5) is arranged in a compressed-air passage (11) of the damper member (8).
  10. Nasal washing device according to the preceding claim, characterized in that the damper member (8) is arranged on the top part (13a) of the casing (13) of the compressor unit (5).
  11. Nasal washing device according to the preceding claim, characterized in that the damper member (8) is sandwiched between the top part (13a) of the casing (13) of the compressor unit (5) and an inner wall (400) of the main body (4).
  12. Nasal washing device according to the preceding claim, characterized in that the main body (4) further comprises :
    - an electrical-power source arranged in the main body (4), electrically-connected to the compressor unit (5) for providing electrical power to said compressor unit (5), and
    - a manual actuator (9) actuable by a user for controlling the delivery of electrical power to said compressor unit (5).
  13. Nasal washing device according to the preceding claim, characterized in that the main body (4) further comprises :
    - a (micro-)USB socket (45) for recharging the electrical-power source and
    - one or several LEDs (46) for indicating the state of charge of the electrical-power source.
  14. Nasal washing assembly according to any one of the preceding claims, characterized in that the main body (4) comprises a generally-cylindrical or quasi-cylindrical section (42) designed and seized for being handled in one hand by the user, said generally-cylindrical or quasi-cylindrical section (42) being arranged above an enlarged base (41) having a flat bottom (40) so that the nasal washing device (1) can stand in an upright position when laying on a support.
  15. Nasal cleaning set comprising a transport bag containing a nasal washing device (1) according to any one of the preceding claims, preferably it further comprises instructions for use.
EP20175420.7A 2020-05-19 2020-05-19 Nasal washing device for cleaning the nasal cavities of a user Pending EP3912614A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP20175420.7A EP3912614A1 (en) 2020-05-19 2020-05-19 Nasal washing device for cleaning the nasal cavities of a user

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20175420.7A EP3912614A1 (en) 2020-05-19 2020-05-19 Nasal washing device for cleaning the nasal cavities of a user

Publications (1)

Publication Number Publication Date
EP3912614A1 true EP3912614A1 (en) 2021-11-24

Family

ID=70779490

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20175420.7A Pending EP3912614A1 (en) 2020-05-19 2020-05-19 Nasal washing device for cleaning the nasal cavities of a user

Country Status (1)

Country Link
EP (1) EP3912614A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4206467A1 (en) * 2022-01-04 2023-07-05 Air Liquide Medical Systems S.R.L. Compressor device for providing compressed air to a medical device

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004020029A1 (en) * 2002-08-27 2004-03-11 Pari GmbH Spezialisten für effektive Inhalation Therapeutic aerosol device
WO2009017272A1 (en) * 2007-07-27 2009-02-05 Welbutech Co., Ltd. Breathing relief kit
WO2009128109A1 (en) * 2008-04-15 2009-10-22 Flaem Nuova S.P.A. Device for washing nasal cavities with an incorporated pump
EP2732881A1 (en) 2012-11-14 2014-05-21 Air Liquide Medical Systems S.p.A. Micro nebulizer for nasal cleaning or treatment
US20170028144A1 (en) * 2012-02-24 2017-02-02 Medinvent, Llc Nasal Drug Delivery Device and Method of Making Same
CN210472590U (en) * 2019-05-24 2020-05-08 苏州三昧火医疗器械有限公司 Portable nasal cavity flusher

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004020029A1 (en) * 2002-08-27 2004-03-11 Pari GmbH Spezialisten für effektive Inhalation Therapeutic aerosol device
WO2009017272A1 (en) * 2007-07-27 2009-02-05 Welbutech Co., Ltd. Breathing relief kit
WO2009128109A1 (en) * 2008-04-15 2009-10-22 Flaem Nuova S.P.A. Device for washing nasal cavities with an incorporated pump
EP2274033A1 (en) 2008-04-15 2011-01-19 FLAEM NUOVA S.p.A. Device for washing nasal cavities with an incorporated pump
US20170028144A1 (en) * 2012-02-24 2017-02-02 Medinvent, Llc Nasal Drug Delivery Device and Method of Making Same
EP2732881A1 (en) 2012-11-14 2014-05-21 Air Liquide Medical Systems S.p.A. Micro nebulizer for nasal cleaning or treatment
CN210472590U (en) * 2019-05-24 2020-05-08 苏州三昧火医疗器械有限公司 Portable nasal cavity flusher

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4206467A1 (en) * 2022-01-04 2023-07-05 Air Liquide Medical Systems S.R.L. Compressor device for providing compressed air to a medical device

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