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WO2021207187A1 - Appareil nébuliseur comprenant un filtre d'exhalation antimicrobien - Google Patents

Appareil nébuliseur comprenant un filtre d'exhalation antimicrobien Download PDF

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Publication number
WO2021207187A1
WO2021207187A1 PCT/US2021/025954 US2021025954W WO2021207187A1 WO 2021207187 A1 WO2021207187 A1 WO 2021207187A1 US 2021025954 W US2021025954 W US 2021025954W WO 2021207187 A1 WO2021207187 A1 WO 2021207187A1
Authority
WO
WIPO (PCT)
Prior art keywords
nebulizer
filter
patient
exhalation
inhalation
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.)
Ceased
Application number
PCT/US2021/025954
Other languages
English (en)
Inventor
Michael Newhouse
Michael Amato
Akanksha HANDE
Rohinton Toddywala
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.)
INSPIRX Inc
Original Assignee
INSPIRX Inc
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 INSPIRX Inc filed Critical INSPIRX Inc
Publication of WO2021207187A1 publication Critical patent/WO2021207187A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61M11/00—Sprayers or atomisers specially adapted for therapeutic purposes
    • A61M11/06—Sprayers or atomisers specially adapted for therapeutic purposes of the injector type
    • A61M11/08—Pocket atomisers 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
    • 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
    • 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
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/201—Controlled valves
    • A61M16/206—Capsule valves, e.g. mushroom, membrane valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/0021—Mouthpieces therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M16/00—Devices for influencing the respiratory system of patients by gas treatment, e.g. ventilators; Tracheal tubes
    • A61M16/20—Valves specially adapted to medical respiratory devices
    • A61M16/208—Non-controlled one-way valves, e.g. exhalation, check, pop-off non-rebreathing valves
    • A61M16/209—Relief valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/0208—Oxygen
    • 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
    • A61M2202/00—Special media to be introduced, removed or treated
    • A61M2202/02—Gases
    • A61M2202/025—Helium

Definitions

  • a nebulizer apparatus having an exhalation filter that prevents the transmission of infectious particles in the exhaled air of a patient using the nebulizer from entering the environment surrounding the patient.
  • This invention addresses the problem of administering aerosolized drugs from a nebulizer to persons who may have an airborne communicable disease, for example influenza or COVID-19, that is transmitted by viral particles in aerosols or droplets in exhaled air.
  • the exhalation air from such infected persons may be dangerous because these aerosols or droplets can remain suspended in the environment surrounding an infected person and can be inhaled by nearby people causing infection and thereby transmitting the disease.
  • This is a particular problem where such persons are in need of an inhaled drug (for example, albuterol/salbutamol) administered with a nebulizer.
  • nebulizers are of particular therapeutic value for these diseases.
  • inhaled drugs can eliminate or reduce the need for more aggressive interventions, such as intubation and ventilators. At the same time, it is not convenient to use conventional interventions (such as masks) to prevent expulsion of infectious agents from infected persons while using a device such as a nebulizer.
  • conventional interventions such as masks
  • This invention addresses the problem of transmission of infectious diseases from persons who may have an infectious disease transmissible by exhaled aerosols, droplets, or particles, wherein such persons are in need of inhaled drugs administered using a nebulizer.
  • This invention employs an exhalation pathway on a nebulizer apparatus having a bacteriostatic and virostatic exhalation filter to trap exhaled aerosols, droplets, or particles so that infectious agents in the exhaled air are not released into the environment surrounding the person using a nebulizer. This may minimize the exposure of nearby persons, such as caregivers, to potentially infectious agents.
  • this invention provides a nebulizer apparatus for the administration of aerosolized drugs to a patient.
  • the apparatus may have a nebulizer body having an inhalation valve that only allows breathing air to enter the nebulizer during an inhalation, a drug solution reservoir, and a compressed air inlet to drive the nebulization of the drug solution to form aerosolized drug.
  • the apparatus may further have a mouthpiece for insertion into the mouth of the patient that conveys aerosolized drug into the mouth of the patient during inhalation, wherein the mouthpiece is in fluid communication with an aerosol outlet on the nebulizer.
  • the nebulizer may have a tee-connector linking the mouthpiece with the aerosol outlet on the nebulizer, wherein a third connection of the tee-connector is to an exhalation filter having a one-way valve that only permits exhaled air to pass to the filter during exhalation, wherein all exhaled air passes through the exhalation filter.
  • the exhalation filter traps droplets of water and other potentially infectious particles to prevent the transmission of exhaled vapor and liquid from transmitting infectious disease to surrounding persons.
  • the nebulizer is a jet nebulizer.
  • the nebulizer may be a breath-enhanced nebulizer.
  • the nebulizer may be a breath -actuated nebulizer.
  • the nebulizer may further comprise a whistle on the nebulizer that makes an audible sound during inhalation, to indicate that an inhalation is occurring at an appropriate rate of air flow entering the nebulizer body.
  • the outlet port on the exhalation filter is at a 90° angle from the inhalation airway from the nebulizer body to the mouthpiece.
  • the exhalation filter may be angled away from the face of the patient.
  • Fig. 1. is a perspective view of an embodiment of the inventive device, showing a nebulizer with an exhalation filter.
  • FIG. 2 is a perspective partial cutaway view of an embodiment of the inventive device, showing a nebulizer with exhalation filter, and showing certain internal features.
  • Fig. 3 is a cross-section view of an embodiment of the inventive device showing the exhalation filter tilted away from the face of the patient, and the internal components.
  • Fig. 4 is an exploded view of an embodiment of the inventive nebulizer apparatus.
  • Fig. 5 is a schematic of the airflow though the apparatus during inhalation.
  • Fig. 6 is a schematic of the airflow through the apparatus during exhalation.
  • FIG. 7 is a perspective view of an embodiment of the inventive device using a breath-actuated nebulizer.
  • Fig. 8 is a cross-section view of the nebulizer of Fig. 8 showing certain internal features.
  • Fig. 9 is a perspective view of a nebulizer with an inhalation mask.
  • a nebulizer apparatus 100 is provided for the administration of aerosolized drugs to a patient.
  • a jet nebulizer is shown in all of the figures, but other nebulizer designs are within the scope of this invention, including other jet nebulizer designs, ultrasonic, and vibrating mesh nebulizers. Any of these designs can be fitted with the inventive exhalation filter.
  • the terms “nebulization” is equivalent to “atomization” and “aerosolization.”
  • the apparatus may include a nebulizer body 202 having a top cap 230 with a one-way inhalation valve 232 in the top cap that only allows breathing air to enter the nebulizer during an inhalation portion of a breathing cycle.
  • the inlet airway may include a whistle 234 to indicate that an inhalation is occurring.
  • the whistle is configured so that the tone is generated at an optimal inhalation rate. If the patient is inhaling too gently or too vigorously, the whistle may make no sound. But at an optimal rate, for example 0.5 L/sec, the whistle makes a sound indicating that the patient is inhaling appropriately.
  • nebulizer 100 has a chimney 220 forming an airway to the Venturi section 212.
  • Compressed gas 211 entering through inlet port 209 on inlet stem 208 drives the nebulization of the drug solution to form aerosolized drug.
  • the compressed gas may be ordinary compressed air, or it can be another suitable breathing gas, such as an oxygen enriched gas flow or a helium-oxygen mixture (“heliox”).
  • nebulization is affected by a Venturi section 212, in which the compressed air (or another breathing gas) 211 from inlet 208 is forced through an orifice to create a jet that creates a localized area of reduced pressure.
  • a capillary tube (or other liquid passageway) adjacent to the Venturi orifice draws a drug solution liquid from drug solution reservoir 240 into Venturi.
  • channel 210 nests over compressed air inlet 208 to form a capillary-like channel allowing the Venturi to draw drug solution into the Venturi section.
  • the liquid is ejected from the liquid passageway into the jet, where the drug solution is aerosolized (i.e.
  • nebulized by shear forces in the Venturi jet.
  • Patent Application WO20108/045263 A1 published Mar. 3, 2018, the contents of which are incorporated by reference.
  • a jet nebulizer is illustrated in the drawings and described here, the inventive concept herein is not limited to jet nebulizers and can be used with other types of nebulizers, for example vibrating mesh and ultrasonic nebulizer styles or other atomizers such as the Boehringer Ingelheim “RESPIMAT®.”.
  • the nebulized drug flow is directed upward through the nebulized aerosol airway 224 in the body of the nebulizer 202 (Fig. 5).
  • One or more baffles 222 may be present in airway 224 to prevent or minimize larger particles and droplets from exiting the nebulizer. Large particles and droplets of the drug solution will tend to stick to the inhalation airway including section 310, section 300, or the mouth and throat of the patient. This all results in wasted drug and potentially adverse effects from oversize particles that enter the mouth of the patient. Baffles 222 catch larger particles and force them back into drug reservoir 240, so they are not wasted.
  • the nebulized drug flow exits the main body of the nebulizer through outlet port 204.
  • the nebulized drug flow is directed to mouthpiece 300 via tee-connector 310.
  • collar 206 that may assist with the seating of an attachment to the outlet port of the nebulizer.
  • a mouthpiece 300 having airway port 302 is provided for insertion into the mouth of the patient that conveys aerosolized drug into the mouth of the patient during inhalation, wherein the mouthpiece is in fluid communication with an aerosol outlet on the nebulizer 204.
  • a breathing mask 304 may be provided rather than mouthpiece 300.
  • Various embodiments of breathing masks are useful for this purpose. Embodiments of a breathing mask are shown in co-pending application
  • a mask 304 useful in this context covers the nose or nose and mouth and has no exhalation port on the mask itself, so that all exhaled air is vented through the exhalation filter 400.
  • a tee-connector 310 links the mouthpiece or breathing mask with the aerosol outlet 204 on the nebulizer, wherein a third connection of the tee-connector forms an exhalation airway leading to an exhalation filter 400 containing filter membrane 402.
  • the airway to filter 400 includes a one-way exhalation valve 430 that only permits exhaled air to pass to the filter during exhalation, and wherein all exhaled air passes through the exhalation filter. Also shown is exhalation valve housing 440. That is, during inhalation, no air can pass from 400 to mouthpiece 300 because that direction of flow is blocked by one-way exhalation valve 430.
  • inhalation valve 232 on the top of nebulizer body 202 is a one-way valve that blocks air flow from exiting the nebulizer body.
  • inhalation valve 232 on the top of nebulizer body 202 is a one-way valve that blocks air flow from exiting the nebulizer body.
  • all of these one-way air valves may be a flap of flexible rubber with a seat so that in the permitted direction, the flap is lifted off the seat to allow air to flow in the desired direction, but in the unpermitted direction, the flap is seated and blocks airflow.
  • the exhalation filter 400 prevents the transmission of infectious disease particles that may be present in the exhaled vapor and liquid from exposing surrounding persons to contagions.
  • Airborne infectious agents include SARS-CoV-2, SARS-CoV-1, Middle East respiratory syndrome- related coronavirus (MERS-CoV), Adenovirus, Influenza A, including subtypes, Influenza B, Parainfluenza viruses, including types 1, 2, 3, and 4, Rhinovirus/Enterovirus, Metapneumovirus, Respiratory Syncytial Virus, including subtypes A and B, varicella zoster virus, Bordetella pertussis, Mycobacterium tuberculosis, Measles morbillivirus, and others.
  • the exhalation filter 400 is a filter such as the ViroMaxTM bacterial-viral filter (available from A-M Systems, LLC, Sequim, WA 98382, or a similar device available from Ventlab-SunMed (filter FH603003), Grand Rapids, Ml 49544, and others, shown as 400 in the figures.
  • a filter is designed to trap aerosolized infectious agents, such as bacteria, viruses, fungi, or prions in exhaled air from a patient.
  • this filter can trap aerosol water droplets that carry infectious agents.
  • These filters have a tubular connector on either side of the filter housing.
  • this filter may be characterized as a “bacterial filter,” this filter can trap exhaled droplets that are believed to convey infectious agent for diseases such as COVID-19.
  • the exhalation valve is removable and replaceable.
  • the bacterial/viral filter is not washable, while the chamber can be washed.
  • the bacterial/viral filter is replaced after known number of treatments to prevent contamination or clogging of the filter. Additionally, if the filter becomes wet it may lose its filtration capacity.
  • the filter inlet channel 410 is connected to the third branch of T-connector 310.
  • a one-way valve exhalation valve 430 is interposed between T-connector 310 and exhalation filter 400.
  • the exhalation one-way valve only permits exhaled air to pass to the filter during exhalation. Because of the one-way inhalation valve 232 in the nebulizer body 202, all exhaled air from the patient passes through the exhalation filter.
  • the exhalation filter prevents the transmission of exhaled vapor and liquid from transmitting infectious disease to surrounding persons.
  • the outlet channel 420 on filter housing 400 has outlet port 422 and is open to ambient air.
  • the branch of T-connector 310 leading to filter 400 is at a right angle, as shown by 312.
  • the branch of T-connector 310 leading to filter 400 is angled away (313), at about a 75° angle with respect to the nebulizer, thereby angling the filter away from the face of the patient.
  • FIG. 5 The operation of the inventive apparatus is illustrated in Figs. 5-7 showing air flows by symbols.
  • the legend of symbols in Fig. 5 applies to Figs. 6 and 7 also.
  • Fig. 5 shows the inhalation portion of a breathing cycle.
  • air from atmosphere 330 enters the nebulizer from the top and passes through one-way inhalation filter 232 and is channeled through chimney 220 (inspiratory airway) to Venturi section 212, where aerosolized drug solution is formed from a solution of the drug in reservoir 240.
  • the aerosol, blended with atmospheric air, is channeled to post-Venturi section 214.
  • the airflow is subjected to a 180° turn in area 214, which helps in returning large droplets to the drug reservoir.
  • the air flow then moves up in channel 224 defined by the exterior of chimney 220 and the interior wall of nebulizer body 202 to nebulizer output port 204.
  • the blend of atmospheric air, aerosol, and compressed gas is channeled to mouthpiece 300 or an inhalation mask (not shown) and exits as flow 320 into the mouth of the patient.
  • the blend of atmospheric air, aerosol, and compressed gas cannot exit to the exhalation filter 400 because one-way exhalation valve 430 blocks airflow to the filter.
  • exhaled air flow 322 from the patient’s mouth enters mouthpiece 300 and is channeled through T-connector branch 312 (313 in the tilted embodiment).
  • the airflow travels through exhalation filter 430, though the filter, and exits at port 422 to the atmosphere.
  • inhalation valve 232 is in fluid communication with the airway, and inhalation valve 232 blocks airflow exiting, all the exhaled air is forced through exhalation filter 400.
  • exhaled infectious agents such as bacteria, viruses, and aerosol droplets and exhaled liquid bearing infectious agents are trapped in exhalation filter 400.
  • the transmission of infectious agents from a patient having a highly infectious disease using the inventive nebulizer with exhalation filter is prevented, thereby providing a safer environment to doctors, nurses, respiratory therapists, and other persons in the vicinity of a patient using the nebulizer.
  • the nebulizer may be a breath-actuated nebulizer, in which nebulization only occurs during the inhalation portion of a breathing cycle. Breath- actuation may be generally useful to avoid nebulizing drugs when the patient is not inhaling, which can cause wasted drug, and this technique may also be important with certain expensive drugs where loss of drug product is a particular concern.
  • Fig. 7 is an exterior perspective view of 102
  • Fig. 8 is a cross section view.
  • the exemplary breath-actuated nebulizer has a body 203 and a selector housing 250 containing a diaphragm 252.
  • a negative pressure occurs in the interior of nebulizer 203 that causes diaphragm 252 to flex inward, and that forces a baffle member 254 to shift position such that the baffle is positioned directly over the Venturi jet 212, thereby creating the Venturi effect that draws the drug solution from the drug reservoir 240 to the Venturi 212 through channel 210, and thereby generate nebulized drug solution.
  • the nebulizer may a breath enhanced nebulizer, which provides an amplification of the Venturi effect to increase the rate of nebulization of the drug. This is discussed in Patent Application WO20108/045263 A1 published Mar. 3, 2018 (cited above). Breath enhanced nebulizers include a constriction in the vicinity of the Venturi that amplifies the Venturi effect and increases the flow of drug solution into the Venturi section and thereby increases the rate at which drug aerosol is formed.
  • the patient is suffering from a contagious infectious disease.
  • Some exemplary drugs that may be useful in this apparatus include the following. This is not meant to be an exhaustive list, and some of these drugs may not be approved for respiratory administration.

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

Abstract

Appareil nébuliseur comprenant un filtre d'exhalation qui empêche la transmission de vapeur exhalée et la transmission, par des aérosols, d'une maladie infectieuse à des personnes se trouvant à proximité. Dans un mode de réalisation, un raccord en té est disposé entre un corps de nébuliseur et l'embout buccal ou le masque d'inhalation, un troisième raccordement du raccord en té conduisant à un filtre bactériostatique et virostatique. Une valve d'inhalation unidirectionnelle et une valve d'exhalation unidirectionnelle sont prévues, de telle sorte que l'intégralité de l'air exhalé est canalisée à travers le filtre d'exhalation.
PCT/US2021/025954 2020-04-07 2021-04-06 Appareil nébuliseur comprenant un filtre d'exhalation antimicrobien Ceased WO2021207187A1 (fr)

Applications Claiming Priority (6)

Application Number Priority Date Filing Date Title
US202063006688P 2020-04-07 2020-04-07
US63/006,688 2020-04-07
US202063020295P 2020-05-05 2020-05-05
US63/020,295 2020-05-05
US202063076446P 2020-09-10 2020-09-10
US63/076,446 2020-09-10

Publications (1)

Publication Number Publication Date
WO2021207187A1 true WO2021207187A1 (fr) 2021-10-14

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Application Number Title Priority Date Filing Date
PCT/US2021/025954 Ceased WO2021207187A1 (fr) 2020-04-07 2021-04-06 Appareil nébuliseur comprenant un filtre d'exhalation antimicrobien

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2954027A (en) * 1958-08-26 1960-09-27 Paul B Marasco Face mask
US4703753A (en) * 1982-04-30 1987-11-03 Cadema Medical Products, Inc. Radioactive aerosol inhalation apparatus
EP0281650B1 (fr) * 1987-03-10 1992-03-04 Brugger, Stephan, Dipl.-Wirt.-Ing. Pulvérisateur d'aérosol
US7418962B1 (en) * 2007-05-25 2008-09-02 Rao C P Inhaler for aerosol medication
WO2020002351A1 (fr) * 2018-06-27 2020-01-02 Breath Therapeutics Gmbh Compositions inhalables comprenant des immunosuppresseurs macrocycliques

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2954027A (en) * 1958-08-26 1960-09-27 Paul B Marasco Face mask
US4703753A (en) * 1982-04-30 1987-11-03 Cadema Medical Products, Inc. Radioactive aerosol inhalation apparatus
EP0281650B1 (fr) * 1987-03-10 1992-03-04 Brugger, Stephan, Dipl.-Wirt.-Ing. Pulvérisateur d'aérosol
US7418962B1 (en) * 2007-05-25 2008-09-02 Rao C P Inhaler for aerosol medication
WO2020002351A1 (fr) * 2018-06-27 2020-01-02 Breath Therapeutics Gmbh Compositions inhalables comprenant des immunosuppresseurs macrocycliques

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