WO2000015282A1 - Nebuliseur - Google Patents

Nebuliseur Download PDF

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Publication number
WO2000015282A1
WO2000015282A1 PCT/IL1999/000492 IL9900492W WO0015282A1 WO 2000015282 A1 WO2000015282 A1 WO 2000015282A1 IL 9900492 W IL9900492 W IL 9900492W WO 0015282 A1 WO0015282 A1 WO 0015282A1
Authority
WO
WIPO (PCT)
Prior art keywords
aerosol
flow
droplets
vortex
nebulizer
Prior art date
Application number
PCT/IL1999/000492
Other languages
English (en)
Inventor
Nitzan Eliyahu
Alexander Arenshtam
Original Assignee
Aerotron Medical Instrumentation Ltd.
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 Aerotron Medical Instrumentation Ltd. filed Critical Aerotron Medical Instrumentation Ltd.
Priority to AU56464/99A priority Critical patent/AU5646499A/en
Publication of WO2000015282A1 publication Critical patent/WO2000015282A1/fr

Links

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
    • A61M15/00—Inhalators
    • A61M15/0086—Inhalation chambers
    • 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
    • A61M11/001—Particle size control
    • A61M11/002—Particle size control by flow deviation causing inertial separation of transported particles
    • 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
    • A61M11/005—Sprayers or atomisers specially adapted for therapeutic purposes using ultrasonics
    • 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
    • A61M15/00—Inhalators
    • A61M15/0085—Inhalators using ultrasonics
    • 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
    • A61M2206/00—Characteristics of a physical parameter; associated device therefor
    • A61M2206/10—Flow characteristics
    • A61M2206/16—Rotating swirling helical flow, e.g. by tangential inflows

Definitions

  • the present invention relates to the generation of very fine aerosols for medical and other applications.
  • Aerosols gaseous suspensions of fine droplets or particles
  • inhalation therapy medical substances are introduced to the body via the lungs. Absorption of inhaled medical substances into the blood primarily occurs in the alveoli of the lungs. Measurements have shown that only the smallest air suspended particles or droplets can normally reach the alveoli. Droplets of about 50 microns in diameter reach the trachea; to penetrate the bronchial tubes requires diameters in the range 10-30 microns; while only droplets 1-3 microns or smaller normally can reach the alveoli. Most efficient dosage is thus generally obtained by increasing the number of smaller droplets in an aerosol for inhalation. This is a particular concern as medications become more expensive. Another related concern is to synchronize aerosol generation to a patient's breathing so as to provide the medicine only during inhalation.
  • Nebulizers devices for fine aerosol generation, include compressed air or jet nebulizers, mechanical or filter nebulizers, or ultrasound nebulizers.
  • Most currently known devices have the disadvantages of producing aerosols with a significant proportion of large droplets, typically 3-10 microns, and limited or no capability to synchronize their operation with patient breathing.
  • a further disadvantage is that they require a relatively large amount of liquid, i.e., the medicine, relative to the amount of aerosol generated.
  • U.S. Patent 5,170,782 discloses an improved aerosol chamber for an ultrasonic nebulizer employing an annular space to create a cyclone effect in the aerosol flow with a baffle to deflect larger droplets from the flow.
  • U.S. Patent 5,335,860 discloses a rotary spray chamber for conditioning aerosols which imparts a rotary motion to the aerosol in the chamber and employs an impact member extending from the chamber wall into the flow to remove large droplets from the flow. Both of these cannot make smaller droplets than those in the original aerosol and do not use the liquid or medicament removed from the flow.
  • the present invention seeks to provide a nebulizer and a method for generating very fine aerosols with a large proportion of droplets with a diameter one micron or less with more efficient use of the input liquid than is achieved in known art.
  • a nebulizer for producing a fine aerosol of droplets of a predetermined range of sizes, which includes an antechamber with a gas inlet, arranged for receiving a pressurized gas flow thereby and for containing a pressurized gas therein; a vortex chamber arranged to receive a pressurized gas flow from the antechamber and configured to produce a vortex-like flow of the pressurized gas; a mixing chamber for receiving the vortex-like flow from the vortex chamber; a preliminary aerosol generator having a predetermined fluid capacity and operative to produce, from a preselected fluid provided thereto, a coarse aerosol of droplets of a predetermined range of sizes and to provide the coarse aerosol to the mixing chamber to combine it with the vortex-like flow of the pressurized gas therein thereby to provide a mixed flow; a processing chamber for receiving the mixed flow from the mixing chamber and further configured to change the flow characteristics thereof in a predetermined manner,
  • the preliminary aerosol generator includes a dosage device operative to provide a predetermined measure of a preselected fluid thereto.
  • the preliminary aerosol generator may be a jet aerosol generator or an ultrasonic aerosol generator, which includes a piezoelectric disk assembly, a fluid container in association therewith, and an ultrasound frequency generator to drive the piezoelectric disk assembly.
  • the fluid container may be a double fluid container including a first container containing water and a second container containing the preselected fluid from which it is desired to produce an aerosol.
  • the ultrasonic aerosol generator may further include a reflector element configured to reflect back into the fluid container a substantially greater number of larger-sized droplets than smaller-sized droplets from a preliminary aerosol, thereby providing a coarse aerosol having a droplet size distribution containing a substantially greater number of smaller-sized droplets than that of the preliminary aerosol.
  • the nebulizer further includes a pressurized gas source which communicates with the gas inlet of the antechamber and which includes a microcompressor.
  • a controller for controlling the pressurized gas source and the preliminary aerosol generator, and an electric power supply therefor.
  • a protrusion extending inwardly from an outer wall of the processing chamber and located to partially obstruct the mixed flow and operative to further change the flow characteristics and to shatter droplets thereof, wherein the mixed flow upstream from the at least one protrusion is an intermediate aerosol having a droplet size distribution containing a substantially greater number of smaller-sized droplets than that of the coarse aerosol, and wherein the mixed flow downstream from the at least one protrusion is a fine aerosol having a droplet size distribution containing a greater number of smaller-sized droplets than that of the intermediate aerosol.
  • the controller is operative to run in a duty cycle so that the nebulizer produces a predetermined quantity of the fine aerosol during no more than a predetermined time interval.
  • the preliminary aerosol generator is activated for a time interval greater than 10% but no more than 50% of the duty cycle.
  • a method for producing a fine aerosol including the steps of producing a pressurized gas flow, changing the gas flow to a vortex-like flow, producing a coarse aerosol, mixing the coarse aerosol with the vortex-like gas flow, and changing the flow characteristics of the mixed flow in a manner operative to shatter and select out larger-sized aerosol droplets to produce a finer aerosol.
  • the step of changing the flow characteristics is changing the mixed flow to turbulent flow. Further in accordance with the method of the invention, there is provided the step of adding a turbulent disturbance in the mixed flow in a manner operative to shatter and select out larger-sized aerosol droplets to produce a still finer aerosol.
  • the step of producing a coarse aerosol includes the substeps of producing a preliminary aerosol and selecting out larger-sized aerosol droplets to produce a coarse aerosol.
  • Figure 1 is a longitudinal sectional view of a nebulizer constructed and operative in accordance with a preferred embodiment of the present invention
  • Figure 2 is a cross-sectional view of the nebulizer of Figure 1 , taken along line A- A therein;
  • Figure 3 is a longitudinal sectional view of a dosage device
  • Figure 4 is a longitudinal sectional view of the nebulizer of Figure 1 , with the dosage device of Figure 3 installed thereon;
  • Figure 5 is a longitudinal sectional view of a nebulizer with a dosage device installed thereon constructed and operative in accordance with an alternative embodiment of the present invention
  • Figure 6 is a block diagram of a nebulizer constructed and operative in accordance with the present invention.
  • Figure 7 is a graphical representation of the aerosol droplet size distribution produced by the present invention.
  • Figure 8a is a schematic graphical representation of a duty cycle of the present invention
  • Figure 8b is a schematic graphical representation of an alternative duty cycle of the present invention.
  • Figure 9 is a longitudinal sectional view of a nebulizer constructed and operative in accordance with an alternative preferred embodiment of the present invention.
  • Nebulizer 100 for producing a fine aerosol, constructed and operative in accordance with the present invention.
  • Nebulizer 100 includes a metal base 3 supporting a rubber roller cage 2 in which is mounted a piezoelectric disk 1.
  • piezoelectric disk 1 When activated by an ultrasound frequency generator 40 (Fig. 6), piezoelectric disk 1 generates, from a preselected fluid thereto introduced via fluid inlet 6, a preliminary or coarse aerosol.
  • Nebulizer 100 has a series of chambers defined by base 3, together with a typically plastic cap 4 and a central tube structure 7, wherein a fine aerosol is produced from the coarse aerosol produced by operation of piezoelectric disk 1.
  • a generally annular antechamber, referenced 11 receives pressurized gas, typically, but not necessarily, compressed air, via an inlet conduit 21.
  • a membrane microcompressor 42 (Fig. 6), operated by a suitable controller 44 (fig. 6), supplies compressed air, but any suitable source of compressed gas may be used.
  • a suitable controller 44 (fig. 6)
  • Fig. 6 may include another external gas source 46 (Fig. 6), or a manual compressor 48 (Fig. 6), for example.
  • a vortex chamber 10 receives pressurized gas from antechamber 11 via typically two tangential ducts 22.
  • the orientation of ducts 22 creates a rapid, circular or vortex-like, flow of the gas in vortex chamber 10.
  • the vortex-like flow passes largely unimpeded from vortex chamber 10 via an annular gap 23, which is formed about a lower portion 7a of central tube structure 7, to mixing chamber 12, wherein it mixes with the coarse aerosol produced by piezoelectric disk 1.
  • Mixing chamber 12 feeds the mixed vortex-like flow into processing chamber 9 via lower portion 7a of central tube structure 7.
  • the conical-like shape of lower portion 7a of central tube structure 7 accelerates the mixed vortex-like flow by reducing the vortex radius to that of processing chamber 9; thereby changing the flow characteristics of the mixed vortex-like flow to shatter and select out larger-sized aerosol droplets to produce a finer aerosol having a droplet size distribution containing a substantially greater number of smaller-sized droplets than that of the coarse aerosol.
  • the flow in processing chamber 9 is changed into turbulent flow to accomplish this change in the aerosol.
  • a pin-like protrusion 8 is embedded in the wall of processing chamber 9 located to partially obstruct the mixed vortex-like flow therein.
  • Protrusion 8 which typically extends inward no more than one fourth the radius of processing chamber 9, serves to introduce an additional turbulent disturbance to the mixed vortex-like flow to enhance the shattering of the larger aerosol droplets to produce a still finer aerosol.
  • FIG. 7 there is shown a graphical representation of measurements of the aerosol droplet size distribution produced by the nebulizer of the present invention.
  • the graphs readily show a high concentration of smaller droplets ("particles") produced by the nebulizer of the present invention.
  • the pressurized gas entering antechamber 11 serves to drive the gas and aerosol through the sequence of chambers of nebulizer 100 and finally out thereof via a delivery tube 5.
  • delivery tube 5 is formed so as to receive onto an end 5a thereof, a mouthpiece 5b.
  • the preliminary or coarse aerosol is produced by piezoelectric disk 1 when it is activated by an ultrasound frequency generator, operating in the present embodiment at a frequency of 2.4 MHz, in the presence of a preselected fluid, introduced via fluid inlet 6.
  • an ultrasound frequency generator operating in the present embodiment at a frequency of 2.4 MHz
  • aerosols produced ultrasonically have droplets largely in the size range from 3 to 10 microns.
  • different ultrasound frequencies or piezoelectric geometries could be used to generate the preliminary or coarse aerosol.
  • Nebulizer 200 for producing a fine aerosol, constructed and operative in accordance with an alternative preferred embodiment of the present invention.
  • Nebulizer 200 is generally similar to nebulizer 100, shown and described above in conjunction with Figs. 1 and 2, and nebulizer 200 is thus described herein specifically only with regard to differences between it and nebulizer 100.
  • portions of nebulizer 200 having counterpart portions in nebulizer 100 are identified by similar reference numerals, but having a prefix "2.”
  • the coarse aerosol generator, referenced generally 220 is contained in a removable housing 213, which may be made of plastic, containing piezoelectric disk 201 and a double fluid container.
  • the double fluid container includes a first container 214 in contact with piezoelectric disk 201 and containing water or a suitable fluid for transmitting ultrasonic energy, and a second, removable container 215 in contact with first container 214 and containing a measured amount of fluid medicament or other fluid from which it is desired to produce a fine aerosol.
  • Nebulizer 200 further includes drop reflector 216, which serves to reflect large aerosol droplets back into second container 215, thereby making the coarse aerosol produced by coarse aerosol generator 220 finer than that initially emitted from second container 215.
  • the preliminary aerosol generator may not include drop reflector 216, or a similar drop reflector element may be included in an embodiment such as that shown in Figure 1 , with an annular opening for fluid introduction via fluid inlet 6.
  • preliminary aerosol generator 40 may be a jet or compressed air aerosol generator, although it produces somewhat larger droplets than ultrasound aerosol generators.
  • preliminary aerosol generator 40 may be a standard aerosol generator, even though an aerosol so generated is still coarser.
  • nebulizer 100 is run with a duty cycle wherein piezoelectric disk 1 , referred to as "generator” in the graphs of Figures 8a and 8b, is activated for only very short periods.
  • Alternative duty cycles are illustrated in Figs. 8a and 8b, and are not further described herein.
  • piezoelectric disk 1 may be activated 10-50% of the time. This is consistent with the objective of synchronizing nebulizer operation with the patient's breathing, which requires a controller (not shown) to control activation of the components of nebulizer 100 (Fig. 1) or 200 (Fig. 9).
  • a dosage device and its usage with nebulizer 100 for dispensing a measured amount of medicament into nebulizer 100.
  • the medicament can be introduced into nebulizer 100 from the top, as shown in Figure 4, or from the side as in Figure 5.
  • Reservoir 35 contains medicament for one series of treatments, which pass one dose at a time into dosing container 36 via canal 37.
  • Piston 33 is driven down to close canal 37 and drive the dose through outlet capillary 38 into nebulizer 100. Closure of canal 37 provides a measured dose with each cycle of piston 33, which is returned to its ready position by spring 34.
  • Dosage device 300, or at least reservoir 35 is made of a transparent material to facilitate monitoring of the quantity of medicament they contain.
  • a dosage will be 0.1 ml of fluid and reservoir 35 has a capacity of 2 ml, allowing 20 dosage cycles on one filling by dosage device 300.

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

Abstract

L'invention concerne un nébuliseur (100) est destiné à la production d'un aérosol fin fait de gouttelettes d'une plage définie de calibres. Ce nébuliseur se compose d'une antichambre (11), d'une chambre de turbulence, d'une chambre de mélange, d'un générateur d'aérosol préliminaire, d'une chambre de traitement, et d'un tube d'administration. L'antichambre, qui comporte une entrée de gaz (21), est agencée de façon à recevoir un courant de gaz pressurisé et à contenir un gaz pressurisé. La chambre de turbulence (10), qui est agencée de façon à recevoir un courant de gaz pressurisé en provenance l'antichambre, est configurée de façon à produire un courant tourbillonnaire de gaz pressurisé. La chambre de mélange (12) a pour objet de recevoir le courant tourbillonnaire en provenance de la chambre de turbulence. Le générateur d'aérosol préliminaire, qui possède une capacité de fluide définie, a pour fonction, d'une part de produire, à partir du fluide présélectionné qui y a été apporté, un aérosol grossier de gouttelettes d'une plage définie de calibres, et d'autre part de fournir dans la chambre de mélange l'aérosol grossier de gouttelettes d'une plage définie de calibres pour qu'il se combine avec le courant tourbillonnaire de gaz pressurisé de façon à constituer un courant mélangé. La chambre de traitement (9), qui sert à recevoir le courant mélangé depuis la chambre de mélange, présente une configuration servant à modifier les caractéristiques du courant d'une façon définie. On réalise ainsi un aérosol fin dont la distribution des calibres des gouttelettes fait apparaître une quantité sensiblement supérieure de gouttelettes de petits calibres que dans l'aérosol grossier. Le tube d'administration (5) sert à transférer hors du nébuliseur l'aérosol fin provenant de la chambre de traitement.
PCT/IL1999/000492 1998-09-14 1999-09-09 Nebuliseur WO2000015282A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU56464/99A AU5646499A (en) 1998-09-14 1999-09-09 Nebulizer

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL126200 1998-09-14
IL12620098A IL126200A0 (en) 1998-09-14 1998-09-14 Nebulizer

Publications (1)

Publication Number Publication Date
WO2000015282A1 true WO2000015282A1 (fr) 2000-03-23

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ID=11071962

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL1999/000492 WO2000015282A1 (fr) 1998-09-14 1999-09-09 Nebuliseur

Country Status (3)

Country Link
AU (1) AU5646499A (fr)
IL (1) IL126200A0 (fr)
WO (1) WO2000015282A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1509259A2 (fr) * 2002-05-20 2005-03-02 AeroGen, Inc. Appareil de realisation d'aerosol pour traitement medical et procedes correspondants
EP3524302A1 (fr) * 2018-02-08 2019-08-14 Nli GmbH Générateur d'aérosol
DE102018005016A1 (de) * 2018-06-18 2019-12-19 Albert Dietrich Wirbelrohr und Inhalationshilfe mit einem solchen

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4228795A (en) * 1977-03-08 1980-10-21 Babington Robert S Apparatus for producing finely divided liquid spray
US4429835A (en) * 1980-11-17 1984-02-07 Inge Brugger Spray-diffuser
EP0504459A1 (fr) * 1991-03-21 1992-09-23 PAUL RITZAU PARI-WERK GmbH Nébuliseur, en particulier à usage dans des appareils pour la thérapie inhalatrice
US5458135A (en) * 1991-07-02 1995-10-17 Inhale Therapeutic Systems Method and device for delivering aerosolized medicaments
US5596982A (en) * 1994-05-19 1997-01-28 Paul Ritzau Pari-Werk Gmbh Apparatus for drying and buffering aerosols

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4228795A (en) * 1977-03-08 1980-10-21 Babington Robert S Apparatus for producing finely divided liquid spray
US4429835A (en) * 1980-11-17 1984-02-07 Inge Brugger Spray-diffuser
EP0504459A1 (fr) * 1991-03-21 1992-09-23 PAUL RITZAU PARI-WERK GmbH Nébuliseur, en particulier à usage dans des appareils pour la thérapie inhalatrice
US5458135A (en) * 1991-07-02 1995-10-17 Inhale Therapeutic Systems Method and device for delivering aerosolized medicaments
US5596982A (en) * 1994-05-19 1997-01-28 Paul Ritzau Pari-Werk Gmbh Apparatus for drying and buffering aerosols

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1509259A2 (fr) * 2002-05-20 2005-03-02 AeroGen, Inc. Appareil de realisation d'aerosol pour traitement medical et procedes correspondants
EP1509259A4 (fr) * 2002-05-20 2007-03-28 Aerogen Inc Appareil de realisation d'aerosol pour traitement medical et procedes correspondants
EP3524302A1 (fr) * 2018-02-08 2019-08-14 Nli GmbH Générateur d'aérosol
US11648358B2 (en) * 2018-02-08 2023-05-16 Nli Gmbh Aerosol generator with offset inlet
DE102018005016A1 (de) * 2018-06-18 2019-12-19 Albert Dietrich Wirbelrohr und Inhalationshilfe mit einem solchen

Also Published As

Publication number Publication date
IL126200A0 (en) 1999-05-09
AU5646499A (en) 2000-04-03

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