WO2020095175A1 - Actuator housing for inhaler device - Google Patents

Actuator housing for inhaler device Download PDF

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Publication number
WO2020095175A1
WO2020095175A1 PCT/IB2019/059447 IB2019059447W WO2020095175A1 WO 2020095175 A1 WO2020095175 A1 WO 2020095175A1 IB 2019059447 W IB2019059447 W IB 2019059447W WO 2020095175 A1 WO2020095175 A1 WO 2020095175A1
Authority
WO
WIPO (PCT)
Prior art keywords
actuator
orifice
mouthpiece
housing
mouthpiece portion
Prior art date
Application number
PCT/IB2019/059447
Other languages
French (fr)
Inventor
Philip A. Jinks
Original Assignee
3M Innovative Properties Company
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 3M Innovative Properties Company filed Critical 3M Innovative Properties Company
Publication of WO2020095175A1 publication Critical patent/WO2020095175A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/009Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M15/00Inhalators
    • A61M15/0001Details of inhalators; Constructional features thereof
    • A61M15/0021Mouthpieces therefor
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00Containers or packages with special means for dispensing contents
    • B65D83/14Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
    • B65D83/75Aerosol containers not provided for in groups B65D83/16 - B65D83/74
    • B65D83/753Aerosol containers not provided for in groups B65D83/16 - B65D83/74 characterised by details or accessories associated with outlets
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00Containers or packages with special means for dispensing contents
    • B65D83/14Containers or packages with special means for dispensing contents for delivery of liquid or semi-liquid contents by internal gaseous pressure, i.e. aerosol containers comprising propellant for a product delivered by a propellant
    • B65D83/38Details of the container body
    • B65D83/384Details of the container body comprising an aerosol container disposed in an outer shell or in an external container
    • B65D83/386Details of the container body comprising an aerosol container disposed in an outer shell or in an external container actuation occurring by moving the aerosol container relative to the outer shell or external container

Definitions

  • the present disclosure relates generally to improvements in or relating to medical actuators and is more particularly concerned with actuators for metered dose inhalers.
  • MDI metered dose inhaler
  • actuators or devices for pulmonary delivery whether they be standard“press-and-breathe” designs or designs employing automatic triggering, are designed to deliver an aerosol plume to the oral cavity.
  • the aerosol plume is delivered through an orifice which is in fluid communication with a fluid source such as a canister.
  • the orifice typically has a circular cross-section through which the aerosol plume enters a mouthpiece which may have a non-circular cross-section.
  • a substantial portion of the aerosol plume may get deposited on the inner walls of the mouthpiece, and also on the tongue and in the mouth of the patient before reaching its intended delivery location. Deposition on the inner walls of the mouthpiece as well as buccal and tongue deposition may substantially reduce delivery efficiency of a medicament. As a result, the patient may not receive the full dose due to such deposition. In addition, there is a possibility of the teeth and lips of the patient also providing obstacles for the plume and further locations for deposition if the actuator is not positioned correctly within the mouth of the patient.
  • the present disclosure provides an actuator housing for a metered dose inhaler device.
  • the actuator housing includes a substantially hollow tubular housing portion having a first proximal end and a first distal end.
  • a base portion is formed at the first proximal end of the housing portion.
  • a nozzle block is formed in the base portion.
  • the nozzle block includes an actuator seat and an actuator orifice in fluid communication with the actuator seat.
  • the actuator orifice is operable for dispensing a spray of metered fluid.
  • the actuator orifice further has a non-circular cross-section perpendicular to its axis of flow.
  • the actuator housing further includes a substantially hollow mouthpiece portion joined to the housing portion and the base portion.
  • the mouthpiece portion has a second proximal end and a second distal end.
  • the second proximal end is located adjacent to the first proximal end.
  • the second distal end defines a mouthpiece end.
  • the mouthpiece portion further has a non-circular cross-section perpendicular to its axis of flow that has a non-circular shape matching the cross-sectional shape of the actuator orifice so as to produce a matching aerosol spray pattern into the mouthpiece portion.
  • the present disclosure further provides a metered dose inhaler having a canister containing a fluid formulated with a medicament.
  • the canister includes a metering valve and a hollow valve stem extending from the metering valve.
  • the canister releases a predetermined amount of fluid through the metering valve upon actuation.
  • the metered dose inhaler further includes the actuator housing such that the valve stem is engaged with the actuator seat of the nozzle block.
  • the present disclosure provides an actuator housing for a metered dose inhaler device.
  • the actuator housing includes a substantially hollow tubular housing portion having a first proximal end and a first distal end.
  • a base portion is formed at the first proximal end of the housing portion.
  • a nozzle block is formed in the base portion.
  • the nozzle block includes an actuator seat and an actuator orifice in fluid communication with the actuator seat.
  • the actuator orifice is operable for dispensing a spray of metered fluid.
  • the actuator orifice can further include a frustoconical configuration defining an axis of flow.
  • the actuator orifice has a non-circular cross- section perpendicular to the axis of flow of the actuator orifice.
  • the actuator housing further includes a substantially hollow mouthpiece portion joined to the housing portion and the base portion.
  • the mouthpiece portion has a second proximal end and a second distal end.
  • the second proximal end is located adjacent to the first proximal end.
  • the second distal end defines a mouthpiece end.
  • the mouthpiece portion further has a non-circular cross-section perpendicular to its axis of flow that has a non-circular shape matching the cross-sectional shape of the actuator orifice so as to produce a matching aerosol spray pattern into the mouthpiece portion.
  • the present disclosure provides a metered dose inhaler device.
  • the metered dose inhaler device includes a canister having a fluid formulated with a medicament.
  • the canister includes a metering valve and a hollow valve stem extending from the metering valve.
  • the canister releases a predetermined amount of fluid through the metering valve upon actuation.
  • the metered dose inhaler further includes an actuator housing.
  • the actuator housing includes a substantially hollow tubular housing portion having a first proximal end and a first distal end.
  • a base portion is formed at the first proximal end of the housing portion.
  • a nozzle block is formed in the base portion.
  • the nozzle block includes an actuator seat for engaging with the valve stem and an actuator orifice in fluid communication with the actuator seat.
  • the actuator orifice is operable for dispensing a spray of the predetermined amount of fluid received from the valve stem.
  • the actuator orifice further includes a non-circular cross-section perpendicular to its axis of flow.
  • the actuator housing further includes a substantially hollow mouthpiece portion joined to the housing portion and the base portion.
  • the mouthpiece portion has a second proximal end and a second distal end.
  • the second proximal end is located adjacent to the first proximal end.
  • the second distal end defines a mouthpiece end.
  • the mouthpiece portion further has a non-circular cross-section perpendicular to its axis of flow that has a non-circular shape matching the cross-sectional shape of the actuator orifice so as to produce a matching aerosol spray pattern into the mouthpiece portion.
  • the present disclosure provides a method of treating a pulmonary condition in a human patient. The method includes providing a metered dose inhaler comprising an actuator housing with an actuator orifice and a mouthpiece portion.
  • the actuator orifice has a non-circular cross-section perpendicular to its axis of flow.
  • the mouthpiece portion has a non-circular cross- section perpendicular to its axis of flow that has a non-circular shape matching the cross-sectional shape of the actuator orifice.
  • the method includes placing at least a part of the mouthpiece portion in the mouth of the human patient.
  • the method further includes actuating the metered dose inhaler while inhaling so that an aerosol spray pattern of metered fluid is dispensed from the actuator orifice and ejected through the mouthpiece portion.
  • the aerosol spray pattern has a non-circular shape that matches the non-circular shape of the cross-section of the mouthpiece portion.
  • FIG. 1 is a sectioned side view of a metered dose inhaler (MDI) device according to one embodiment of the present disclosure
  • FIG. 2 is a sectioned side view of the MDI device shown without a canister according to one embodiment of the present disclosure
  • FIG. 3 is a partial front view of the MDI device showing structural details of a mouthpiece portion and an actuator orifice according to one embodiment of the present disclosure
  • FIG. 4 is schematic representation of a spray pattern produced by the MDI device inside the mouthpiece portion according to one embodiment of the present disclosure
  • FIG. 5 is a partial front view of the MDI device showing structural details of a mouthpiece portion and an actuator orifice according to one embodiment of the present disclosure
  • FIG. 6 is schematic representation of a spray pattern produced by the MDI device inside the mouthpiece portion according to one embodiment of the present disclosure.
  • FIG. 7 is a flow chart depicting steps of a method of treating a pulmonary condition in a human patient through the MDI device.
  • the term“similar” used herein to compare two shapes refers to two shapes having proportional dimensions. Dimensions of the two shapes may differ from each other in magnitude, however the dimensions will be relatively proportional to each other. Therefore, the two shapes are identical, and the corresponding dimensions or sides of the two shapes bear a constant ratio to each other. For example, if two elliptical shapes are similar to each other, then the major and minor axes of one elliptical shape are proportional to the major and minor axes of the other elliptical shape.
  • a ratio between the major axes of the two elliptical shapes is substantially equal to a ratio between the minor axes.
  • matching refers to two shapes that are similar to each other.
  • metered dose inhaler (MDI) actuators comprise a canister-retaining or tubular housing portion and a tubular mouthpiece portion, the tubular mouthpiece portion being angled with respect to an axis extending through the tubular housing portion.
  • a nozzle block that comprises a stem socket and an exit orifice or actuator nozzle.
  • a thumb grip is provided at the bottom of the actuator.
  • the tubular mouthpiece portion may have a circular, elliptical or oblong cross-section.
  • an MDI device an MDI actuator housing and a canister of medicament
  • a plume of medicament is produced from the exit orifice or actuator nozzle into the tubular mouthpiece portion and is inhaled by a patient through the tubular mouthpiece portion.
  • FIG. 1 illustrates a side sectional view of a metered dose inhaler (MDI) device 100.
  • the MDI device 100 includes a canister 102 containing a fluid formulated with a medicament.
  • the canister 102 has a generally cylindrical structure.
  • the canister 102 has a metering valve for metering amount of the fluid exiting the canister 102 corresponding to a single spray pattern or spray plume.
  • the canister 102 further includes a valve stem 104 extending from the metering valve.
  • the valve stem 104 has a generally hollow structure.
  • the canister 102 is adapted to release a predetermined amount of the fluid through the metering valve upon actuation.
  • the canister 102 is removably received within an actuator housing 106 of the MDI device 100.
  • the actuator housing 106 has a tubular housing portion 108.
  • the tubular housing portion 108 has a substantially hollow structure.
  • the tubular housing portion 108 has a first proximal end 110 and a first distal end 112.
  • the canister 102 is received within the actuator housing 106 towards the first distal end 112 of the housing portion 108 such that at least some part of the canister 102 extends outwards of the actuator housing 106 from the first distal end 112.
  • FIG. 2 illustrates the actuator housing 106 without the canister 102 inserted therein.
  • the actuator housing 106 includes a base portion 202 formed at the first proximal end 110 of the housing portion 108.
  • the base portion 202 further includes an outer surface 204 of the base portion 202.
  • the outer surface 204 of the base portion 202 defines a grip section 206 on the outer surface 204.
  • the grip section 206 allows a user to grip the MDI device 100 while using the MDI device 100.
  • the grip section 206 may essentially be a set of protrusions, a set of indents, a sleeve providing a better gripping surface compared to the outer surface 204 of the base portion 202, or any other such structural arrangement.
  • the actuator housing 106 includes a nozzle block 208 formed in the base portion 202.
  • the nozzle block 208 has a substantially hollow tubular shape.
  • the hollow tubular shape of the nozzle block 208 helps the nozzle block 208 to receive the valve stem 104 of the canister 102 within the nozzle block 208.
  • the nozzle block 208 extends upwardly from the base portion 202.
  • the nozzle block 208 includes an actuator seat 210 and an actuator orifice 212.
  • the actuator orifice 212 is fluidly coupled with the actuator seat 210.
  • the actuator orifice 212 is operable for dispensing the spray pattern or spray plume of metered fluid.
  • the actuator orifice 212 defines an axis of flow 214 of the actuator orifice 212.
  • the axis of flow 214 defines a general direction in which a spray of metered fluid is dispensed through the actuator orifice 212.
  • the actuator orifice 212 has a non-circular cross-section perpendicular to the axis of flow 214.
  • the non-circular cross-section may include any suitable cross-sectional shape such as a substantially oval shape, a substantially elliptical shape, or a polygonal shape.
  • the present disclosure is not limited by a type of non-circular shape of the cross-section of the actuator orifice 212.
  • the actuator orifice 212 can have a frustoconical configuration defining the axis of flow 214 of the actuator orifice 212.
  • the actuator orifice 212 includes an orifice portion 226 and a spray cone portion 228.
  • the orifice portion 226 has a non-circular cross-sectional shape which is substantially uniform along the axis of flow 214 of the actuator orifice 212.
  • the spray cone portion 228 further includes a non-circular cross-sectional shape which can increase in size along the axis of flow 214 of the actuator orifice 212.
  • the orifice portion 226 and the spray cone portion 228 are disposed adjacent to each other and are in fluid communication with each other.
  • the frustoconical configuration of the actuator orifice 212 aids in improved shaping of the fluid flowing along the axis of flow 214 and guides the fluid to form the desired aerosol spray pattern as the fluid passes through the actuator orifice 212.
  • the actuator orifice 212 may not have an frustoconical configuration, and instead may have a cylindrical configuration.
  • the actuator orifice 212 may only include the orifice portion 226, and the spray cone portion 228 may be absent.
  • the nozzle block 208 further defines a sump region 216.
  • the sump region 216 is in fluid communication with the actuator seat 210 and the actuator orifice 212.
  • the canister 102 allows metered amount of the fluid to flow through the metering valve into the sump region 216.
  • the fluid enters the sump region 216 and leaves the sump region 216 through the actuator orifice 212 to enter a mouthpiece portion 218.
  • the mouthpiece portion 218 is also a part of the actuator housing 106.
  • the mouthpiece portion 218 is joined to the housing portion 108 and the base portion 202.
  • the mouthpiece portion 218 has a substantially hollow structure.
  • the mouthpiece portion 218 has a second proximal end 220 and a second distal end 222.
  • the mouthpiece portion 218 has a length“L” defined along an axis of flow 215 of the mouthpiece portion 218.
  • the axis of flow 215 defines a general direction in which a spray of metered fluid is dispensed through the mouthpiece portion 218.
  • the length“L” of the mouthpiece portion 218 is defined as a distance between the second proximal end 220 and the second distal end 222.
  • the length“L” of the mouthpiece portion 218 is from about 10 mm to about 25 mm.
  • the present disclosure is not limited by any defined dimensional range of the length“L” of the mouthpiece portion 218.
  • the second proximal end 220 is located adjacent to the first proximal end 110 of the housing portion 108.
  • the second distal end 222 defines a mouthpiece end 224.
  • a user or a patient may put at least a part of the mouthpiece end 224 into his mouth for using the MDI device 100.
  • the mouthpiece portion 218 has a non-circular cross-section perpendicular to the axis of flow 215 of the mouthpiece portion 218.
  • the axis of flow 214 of the actuator orifice 212 and the axis of flow 215 of the mouthpiece portion 218 may be coaxial relative to each other.
  • the axis of flow 214 of the actuator orifice 212 and the axis of flow 215 of the mouthpiece portion 218 intersect with each other such that the actuator orifice 212 and the mouthpiece portion 218 are concentric with respect to each other.
  • the non circular cross-section of the actuator orifice 212 and the non-circular cross-section of the mouthpiece portion 218 are substantially concentric.
  • the non-circular cross-section of the mouthpiece portion 218 has a non-circular shape which matches the cross-sectional shape of the actuator orifice 212.
  • the shape of the non-circular cross-section of the actuator orifice 212 is similar to the shape of the non-circular cross-section of the mouthpiece portion 218.
  • the non-circular shape of the mouthpiece portion 218 may include any suitable shape such as a substantially oval shape, a substantially elliptical shape, or a polygonal shape.
  • the present disclosure is not limited by a type of non-circular shape of the cross-section of the mouthpiece portion 218.
  • FIG. 3 shows further structural details of the actuator orifice 212 and the mouthpiece portion 218.
  • the actuator orifice 212 which includes the orifice portion 226 and the spray cone portion 228, has a non-circular cross-sectional shape.
  • the actuator orifice 212 is drawn to show the structural details of the orifice portion 226 and is not drawn to scale. Additionally, in FIG. 3, the actuator orifice 212 is shown as having a substantially oval cross-sectional shape.
  • the orifice portion 226 can have a cross-sectional area substantially similar to that of a circular-shaped actuator orifice with a diameter of between 0.2 mm and 0.3 mm. In an embodiment particularly useful in dispensing suspensions of medicament, the orifice portion 226 can have a cross-sectional area substantially similar to that of a circular-shaped actuator orifice with a diameter of between 0.2 mm and 0.6 mm.
  • the substantially oval cross-sectional shape of the orifice portion 226 may be defined by a maximum width“Wi” and a minimum width“W2”.
  • the maximum width“Wi” may be defined as a horizontal expanse of the oval shape and the minimum width“W2” may be defined as a vertical expanse of the oval shape.
  • the orifice portion 226 has the maximum width“Wi” of about 0.2 mm to about 0.6 mm. However, the present disclosure is not limited by any defined dimensional range of the maximum width“Wi” of the orifice portion 226, and the maximum width“Wi” may vary as per application requirements.
  • the orifice portion 226 has the minimum width“W2”of about 0.2 mm to about 0.6 mm. However, the present disclosure is not limited by any defined dimensional range of the minimum width“W2” of the orifice portion 226, and the minimum width“W2” may vary as per application requirements.
  • the mouthpiece portion 218 has a non-circular cross-sectional shape.
  • the mouthpiece portion 218 is shown as having a substantially oval cross-sectional shape.
  • the mouthpiece portion 218 has the non-circular cross-section perpendicular to the axis of flow 215 that has a non-circular oval shape matching the cross-sectional shape of the actuator orifice 212. Therefore, cross-sectional dimensions of the actuator orifice 212 and the mouthpiece portion 218 are substantially proportional to each other.
  • the non-circular oval cross- sections of the mouthpiece portion 218 and the actuator orifice 212 are concentric with each other.
  • the mouthpiece portion 218 has an inner surface 302 and an outer surface 304. Dimensions of the mouthpiece portion 218 may be defined as per application requirements.
  • the substantially oval cross-sectional shape of the mouthpiece portion 218 may be defined by a maximum inner width“W3” and a minimum inner width“W4”.
  • the maximum inner width“W3” may be defined as a horizontal expanse of the oval shape and the minimum inner width“WV’may be defined as a vertical expanse of the oval shape.
  • the mouthpiece portion 218 has the maximum inner width “W3” of about 20 mm to about 25 mm.
  • the present disclosure is not limited by any defined dimensional range of the maximum inner width“W3”of the mouthpiece portion 218, and the maximum inner width“W3”may vary as per application requirements.
  • the mouthpiece portion 218 has the minimum inner width“W4” of about 7 mm to about 10 mm.
  • the present disclosure is not limited by any defined dimensional range of the minimum inner width “W4” of the mouthpiece portion 218, and the minimum inner width“W4” may vary as per application requirements.
  • a ratio between the maximum width“Wi” and the maximum inner width“W3” is substantially equal to a ratio between the minimum width“W2” and the minimum inner width“W4” due to the similarity of the cross-sectional shapes of the actuator orifice 212 and the mouthpiece portion 218.
  • a thickness“T” of the mouthpiece portion 218 is defined between the inner surface 302 and the outer surface 304.
  • the thickness“T” may therefore correspond to a wall thickness of the mouthpiece portion 218.
  • the thickness“T” of the mouthpiece portion 218 is about 1 mm.
  • the present disclosure is not limited to any defined dimensional range of the thickness“T” of the mouthpiece portion 218, and the thickness“T” may vary as per application requirements.
  • FIG. 4 schematically shows the non-circular oval cross-section of the mouthpiece portion 218 and a matching aerosol spray pattern (i.e. the spray plume) generated through the actuator orifice 212 due to the similarity of cross-sectional shapes of the mouthpiece portion 218 and the actuator orifice 212.
  • Similarity of cross-sectional shapes of the mouthpiece portion 218 and the actuator orifice 212 produces a matching aerosol spray pattern into the mouthpiece portion 218, thus preventing deposition of the fluid on the inner surface 302 of the mouthpiece portion 218 and ensuring a better delivery of the fluid to the user.
  • Such similarity of cross-sectional shapes minimizes occurrences of buccal and tongue deposition. Further, it also reduces possibility of teeth or lips posing as obstacles in path of the fluid being delivered through the actuator orifice 212.
  • An actuator orifice 612 which includes an orifice portion 626 and a spray cone portion 628, is shown as having a substantially elliptical cross-sectional shape. Dimensions of the actuator orifice 612 may be defined as per application requirements.
  • the substantially elliptical cross-sectional shape of the orifice portion 626 may be defined by a maximum width“W5” and a minimum width“We”. In the illustrated embodiment of FIG. 5, the maximum width“W5” may be defined as a horizontal expanse of the elliptical shape or a major axis of the elliptical shape.
  • the minimum width " We " may be defined as a vertical expanse of the elliptical shape or a minor axis of the elliptical shape.
  • the present disclosure is not limited by any defined dimensional range of the maximum width“W5” of the orifice portion 226, and the maximum width“Wg” may vary as per application requirements.
  • the orifice portion 612 has the minimum width Wf of about 0.2 mm to about 0.6 mm and a maximum width“W5” of about 0.2 mm to about 0.6 mm.
  • a mouthpiece portion 604 is shown as having a substantially elliptical cross-sectional shape.
  • the mouthpiece portion 604 has an inner surface 606 and an outer surface 608. Dimensions of the mouthpiece portion 604 may be defined as per application requirements.
  • the substantially elliptical cross-sectional shape of the mouthpiece portion 604 may be defined by a maximum inner width“W7” and a minimum inner width Wx .
  • the maximum inner width“W7” may be defined as a horizontal expanse of the elliptical shape or a major axis of the elliptical shape.
  • the minimum inner width Wx may be defined as a vertical expanse of the elliptical shape or a minor axis of the elliptical shape.
  • the mouthpiece portion 604 has the maximum inner width“W7” of about 20 mm to about 25 mm. In some embodiments, the mouthpiece portion 604 has the minimum inner width“Ws” of about 12 mm to about 20 mm.
  • the elliptical cross-sectional shape of the actuator orifice 612 is similar to the elliptical cross-sectional shape of the mouthpiece portion 604. Therefore, a ratio between the maximum width “W5” and the maximum inner width“W7” is substantially equal to a ratio between the minimum width “We” and the minimum inner width Wx .
  • FIG. 6 schematically shows the non-circular elliptical cross-section of the mouthpiece portion 604 and a matching aerosol spray pattern or spray plume generated through the actuator orifice 612 due to similarity of cross-sectional shapes of the mouthpiece portion 604 and the actuator orifice 612.
  • Similarity of cross-sectional shapes of the mouthpiece portion 604 and the actuator orifice 612 produces the matching aerosol spray pattern or spray plume into the mouthpiece portion 604, thus preventing deposition of the fluid on the inner surface 606 of the mouthpiece portion 604 and ensuring a better delivery of the fluid to the user.
  • Such similarity of cross-sectional shapes minimizes occurrences of buccal and tongue deposition. Further, it also reduces possibility of teeth or lips posing as obstacles in path of the fluid being delivered through the actuator orifice 612.
  • FIG. 7 illustrates another aspect of the present disclosure.
  • a flow chart depicts steps of a method 700 to treat a pulmonary condition in a human patient.
  • the method 700 includes providing the MDI device 100.
  • the MDI device 100 includes the actuator housing 106 with the actuator orifice 212 and the mouthpiece portion 218.
  • the actuator orifice 212 has a non-circular cross- section perpendicular to its axis of flow 214.
  • the mouthpiece portion 218 has a non-circular cross- section perpendicular to its axis of flow 215.
  • the non-circular cross-section of the mouthpiece portion 218 has a non-circular shape which matches the cross-sectional shape of the actuator orifice 212.
  • the method 700 includes placing at least a part of the mouthpiece portion 218 in the mouth of the human patient.
  • the method 700 further includes actuating the MDI device 100 while inhaling so that an aerosol spray pattern or a spray plume of metered fluid is dispensed from the actuator orifice 212 and ejected through the mouthpiece portion 218.
  • the aerosol spray patern has a non-circular shape that matches the non-circular shape of the cross-section of the mouthpiece portion 218.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
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  • Mechanical Engineering (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)

Abstract

An actuator housing for a metered dose inhaler device includes a substantially hollow tubular housing portion having a first proximal end and a first distal end. A base portion is formed at the first proximal end of the housing portion. A nozzle block is formed in the base portion having an actuator seat and an actuator orifice fluidly coupled with the actuator seat. The actuator orifice dispenses a spray of metered fluid. The actuator orifice has a non-circular cross-section perpendicular to its axis of flow. A substantially hollow mouthpiece portion joined to the housing portion and the base portion has a second proximal end and a second distal end. The mouthpiece portion has a non-circular cross-section perpendicular to its axis of flow that has a non-circular shape matching the cross-sectional shape of the actuator orifice to produce a matching aerosol spray pattern into the mouthpiece portion.

Description

ACTUATOR HOUSING FOR INHAUER DEVICE
TECHNICAL FIELD
The present disclosure relates generally to improvements in or relating to medical actuators and is more particularly concerned with actuators for metered dose inhalers.
BACKGROUND
All metered dose inhaler (MDI) actuators or devices for pulmonary delivery, whether they be standard“press-and-breathe” designs or designs employing automatic triggering, are designed to deliver an aerosol plume to the oral cavity. The aerosol plume is delivered through an orifice which is in fluid communication with a fluid source such as a canister. The orifice typically has a circular cross-section through which the aerosol plume enters a mouthpiece which may have a non-circular cross-section.
A substantial portion of the aerosol plume may get deposited on the inner walls of the mouthpiece, and also on the tongue and in the mouth of the patient before reaching its intended delivery location. Deposition on the inner walls of the mouthpiece as well as buccal and tongue deposition may substantially reduce delivery efficiency of a medicament. As a result, the patient may not receive the full dose due to such deposition. In addition, there is a possibility of the teeth and lips of the patient also providing obstacles for the plume and further locations for deposition if the actuator is not positioned correctly within the mouth of the patient.
SUMMARY
In one aspect, the present disclosure provides an actuator housing for a metered dose inhaler device. The actuator housing includes a substantially hollow tubular housing portion having a first proximal end and a first distal end. A base portion is formed at the first proximal end of the housing portion. A nozzle block is formed in the base portion. The nozzle block includes an actuator seat and an actuator orifice in fluid communication with the actuator seat. The actuator orifice is operable for dispensing a spray of metered fluid. The actuator orifice further has a non-circular cross-section perpendicular to its axis of flow. The actuator housing further includes a substantially hollow mouthpiece portion joined to the housing portion and the base portion. The mouthpiece portion has a second proximal end and a second distal end. The second proximal end is located adjacent to the first proximal end. The second distal end defines a mouthpiece end. The mouthpiece portion further has a non-circular cross-section perpendicular to its axis of flow that has a non-circular shape matching the cross-sectional shape of the actuator orifice so as to produce a matching aerosol spray pattern into the mouthpiece portion. In another aspect, the present disclosure further provides a metered dose inhaler having a canister containing a fluid formulated with a medicament. The canister includes a metering valve and a hollow valve stem extending from the metering valve. The canister releases a predetermined amount of fluid through the metering valve upon actuation. The metered dose inhaler further includes the actuator housing such that the valve stem is engaged with the actuator seat of the nozzle block.
In another aspect, the present disclosure provides an actuator housing for a metered dose inhaler device. The actuator housing includes a substantially hollow tubular housing portion having a first proximal end and a first distal end. A base portion is formed at the first proximal end of the housing portion. A nozzle block is formed in the base portion. The nozzle block includes an actuator seat and an actuator orifice in fluid communication with the actuator seat. The actuator orifice is operable for dispensing a spray of metered fluid. The actuator orifice can further include a frustoconical configuration defining an axis of flow. The actuator orifice has a non-circular cross- section perpendicular to the axis of flow of the actuator orifice. The actuator housing further includes a substantially hollow mouthpiece portion joined to the housing portion and the base portion. The mouthpiece portion has a second proximal end and a second distal end. The second proximal end is located adjacent to the first proximal end. The second distal end defines a mouthpiece end. The mouthpiece portion further has a non-circular cross-section perpendicular to its axis of flow that has a non-circular shape matching the cross-sectional shape of the actuator orifice so as to produce a matching aerosol spray pattern into the mouthpiece portion.
In another aspect, the present disclosure provides a metered dose inhaler device. The metered dose inhaler device includes a canister having a fluid formulated with a medicament. The canister includes a metering valve and a hollow valve stem extending from the metering valve. The canister releases a predetermined amount of fluid through the metering valve upon actuation. The metered dose inhaler further includes an actuator housing. The actuator housing includes a substantially hollow tubular housing portion having a first proximal end and a first distal end. A base portion is formed at the first proximal end of the housing portion. A nozzle block is formed in the base portion. The nozzle block includes an actuator seat for engaging with the valve stem and an actuator orifice in fluid communication with the actuator seat. The actuator orifice is operable for dispensing a spray of the predetermined amount of fluid received from the valve stem. The actuator orifice further includes a non-circular cross-section perpendicular to its axis of flow. The actuator housing further includes a substantially hollow mouthpiece portion joined to the housing portion and the base portion. The mouthpiece portion has a second proximal end and a second distal end. The second proximal end is located adjacent to the first proximal end. The second distal end defines a mouthpiece end. The mouthpiece portion further has a non-circular cross-section perpendicular to its axis of flow that has a non-circular shape matching the cross-sectional shape of the actuator orifice so as to produce a matching aerosol spray pattern into the mouthpiece portion. In another aspect, the present disclosure provides a method of treating a pulmonary condition in a human patient. The method includes providing a metered dose inhaler comprising an actuator housing with an actuator orifice and a mouthpiece portion. The actuator orifice has a non-circular cross-section perpendicular to its axis of flow. The mouthpiece portion has a non-circular cross- section perpendicular to its axis of flow that has a non-circular shape matching the cross-sectional shape of the actuator orifice. The method includes placing at least a part of the mouthpiece portion in the mouth of the human patient. The method further includes actuating the metered dose inhaler while inhaling so that an aerosol spray pattern of metered fluid is dispensed from the actuator orifice and ejected through the mouthpiece portion. The aerosol spray pattern has a non-circular shape that matches the non-circular shape of the cross-section of the mouthpiece portion.
BRIEF DESCRIPTION OF THE DRAWINGS
Exemplary embodiments disclosed herein may be more completely understood in consideration of the following detailed description in connection with the following figures. The figures are not necessarily drawn to scale. Like numbers used in the figures refer to like components. However, it will be understood that the use of a number to refer to a component in a given figure is not intended to limit the component in another figure labeled with the same number.
FIG. 1 is a sectioned side view of a metered dose inhaler (MDI) device according to one embodiment of the present disclosure;
FIG. 2 is a sectioned side view of the MDI device shown without a canister according to one embodiment of the present disclosure;
FIG. 3 is a partial front view of the MDI device showing structural details of a mouthpiece portion and an actuator orifice according to one embodiment of the present disclosure;
FIG. 4 is schematic representation of a spray pattern produced by the MDI device inside the mouthpiece portion according to one embodiment of the present disclosure;
FIG. 5 is a partial front view of the MDI device showing structural details of a mouthpiece portion and an actuator orifice according to one embodiment of the present disclosure;
FIG. 6 is schematic representation of a spray pattern produced by the MDI device inside the mouthpiece portion according to one embodiment of the present disclosure; and
FIG. 7 is a flow chart depicting steps of a method of treating a pulmonary condition in a human patient through the MDI device.
DETAILED DESCRIPTION
In the following description, reference is made to the accompanying figures that form a part thereof and in which various embodiments are shown by way of illustration. It is to be understood that other embodiments are contemplated and may be made without departing from the scope or spirit of the present disclosure. The following detailed description, therefore, is not to be taken in a limiting sense.
The present invention will be described with respect to particular embodiments and with reference to certain drawings, but the invention is not limited thereto. The drawings described are only schematic and are non-limiting. In the drawings, the size of some of the elements may for illustrative purposes be exaggerated and not drawn to scale.
It will be understood that the terms“vertical”,“horizontal”,“top”,“bottom”,“above”, “below”,“left”,“right” etc. as used herein refer to particular orientations of the figures and these terms are not limitations to the specific embodiments described herein.
The term“similar” used herein to compare two shapes refers to two shapes having proportional dimensions. Dimensions of the two shapes may differ from each other in magnitude, however the dimensions will be relatively proportional to each other. Therefore, the two shapes are identical, and the corresponding dimensions or sides of the two shapes bear a constant ratio to each other. For example, if two elliptical shapes are similar to each other, then the major and minor axes of one elliptical shape are proportional to the major and minor axes of the other elliptical shape.
Specifically, a ratio between the major axes of the two elliptical shapes is substantially equal to a ratio between the minor axes.
The term“matching”, as used herein, refers to two shapes that are similar to each other.
Typically, metered dose inhaler (MDI) actuators comprise a canister-retaining or tubular housing portion and a tubular mouthpiece portion, the tubular mouthpiece portion being angled with respect to an axis extending through the tubular housing portion. At a closed bottom end of the tubular housing portion sits a nozzle block that comprises a stem socket and an exit orifice or actuator nozzle. At the bottom of the actuator, a thumb grip is provided. The tubular mouthpiece portion may have a circular, elliptical or oblong cross-section.
In normal operation of an MDI device (an MDI actuator housing and a canister of medicament), a plume of medicament is produced from the exit orifice or actuator nozzle into the tubular mouthpiece portion and is inhaled by a patient through the tubular mouthpiece portion.
However, as described above, there tends to be substantial and undesirable deposition of the medicament on the inner walls of the mouthpiece portion and in the buccal cavity when the medicament is dispensed from a conventional device.
Figure 1 illustrates a side sectional view of a metered dose inhaler (MDI) device 100. The MDI device 100 includes a canister 102 containing a fluid formulated with a medicament. The canister 102 has a generally cylindrical structure. The canister 102 has a metering valve for metering amount of the fluid exiting the canister 102 corresponding to a single spray pattern or spray plume. The canister 102 further includes a valve stem 104 extending from the metering valve. The valve stem 104 has a generally hollow structure. The canister 102 is adapted to release a predetermined amount of the fluid through the metering valve upon actuation.
The canister 102 is removably received within an actuator housing 106 of the MDI device 100. The actuator housing 106 has a tubular housing portion 108. The tubular housing portion 108 has a substantially hollow structure. The tubular housing portion 108 has a first proximal end 110 and a first distal end 112. The canister 102 is received within the actuator housing 106 towards the first distal end 112 of the housing portion 108 such that at least some part of the canister 102 extends outwards of the actuator housing 106 from the first distal end 112.
FIG. 2 illustrates the actuator housing 106 without the canister 102 inserted therein. The actuator housing 106 includes a base portion 202 formed at the first proximal end 110 of the housing portion 108. The base portion 202 further includes an outer surface 204 of the base portion 202. The outer surface 204 of the base portion 202 defines a grip section 206 on the outer surface 204. The grip section 206 allows a user to grip the MDI device 100 while using the MDI device 100. The grip section 206 may essentially be a set of protrusions, a set of indents, a sleeve providing a better gripping surface compared to the outer surface 204 of the base portion 202, or any other such structural arrangement.
The actuator housing 106 includes a nozzle block 208 formed in the base portion 202. The nozzle block 208 has a substantially hollow tubular shape. The hollow tubular shape of the nozzle block 208 helps the nozzle block 208 to receive the valve stem 104 of the canister 102 within the nozzle block 208. The nozzle block 208 extends upwardly from the base portion 202. The nozzle block 208 includes an actuator seat 210 and an actuator orifice 212. The actuator orifice 212 is fluidly coupled with the actuator seat 210. The actuator orifice 212 is operable for dispensing the spray pattern or spray plume of metered fluid.
The actuator orifice 212 defines an axis of flow 214 of the actuator orifice 212. The axis of flow 214 defines a general direction in which a spray of metered fluid is dispensed through the actuator orifice 212. The actuator orifice 212 has a non-circular cross-section perpendicular to the axis of flow 214. The non-circular cross-section may include any suitable cross-sectional shape such as a substantially oval shape, a substantially elliptical shape, or a polygonal shape. The present disclosure is not limited by a type of non-circular shape of the cross-section of the actuator orifice 212. The actuator orifice 212 can have a frustoconical configuration defining the axis of flow 214 of the actuator orifice 212. The actuator orifice 212 includes an orifice portion 226 and a spray cone portion 228. The orifice portion 226 has a non-circular cross-sectional shape which is substantially uniform along the axis of flow 214 of the actuator orifice 212. The spray cone portion 228 further includes a non-circular cross-sectional shape which can increase in size along the axis of flow 214 of the actuator orifice 212. The orifice portion 226 and the spray cone portion 228 are disposed adjacent to each other and are in fluid communication with each other. The frustoconical configuration of the actuator orifice 212 aids in improved shaping of the fluid flowing along the axis of flow 214 and guides the fluid to form the desired aerosol spray pattern as the fluid passes through the actuator orifice 212. In one embodiment, the actuator orifice 212 may not have an frustoconical configuration, and instead may have a cylindrical configuration. In an additional embodiment, the actuator orifice 212 may only include the orifice portion 226, and the spray cone portion 228 may be absent.
The nozzle block 208 further defines a sump region 216. The sump region 216 is in fluid communication with the actuator seat 210 and the actuator orifice 212. When actuated, the canister 102 allows metered amount of the fluid to flow through the metering valve into the sump region 216. The fluid enters the sump region 216 and leaves the sump region 216 through the actuator orifice 212 to enter a mouthpiece portion 218.
The mouthpiece portion 218 is also a part of the actuator housing 106. The mouthpiece portion 218 is joined to the housing portion 108 and the base portion 202. The mouthpiece portion 218 has a substantially hollow structure. The mouthpiece portion 218 has a second proximal end 220 and a second distal end 222. The mouthpiece portion 218 has a length“L” defined along an axis of flow 215 of the mouthpiece portion 218. The axis of flow 215 defines a general direction in which a spray of metered fluid is dispensed through the mouthpiece portion 218. Further, the length“L” of the mouthpiece portion 218 is defined as a distance between the second proximal end 220 and the second distal end 222. In some embodiments, the length“L” of the mouthpiece portion 218 is from about 10 mm to about 25 mm. However, the present disclosure is not limited by any defined dimensional range of the length“L” of the mouthpiece portion 218.
As illustrated in FIG. 2, the second proximal end 220 is located adjacent to the first proximal end 110 of the housing portion 108. The second distal end 222 defines a mouthpiece end 224. A user or a patient may put at least a part of the mouthpiece end 224 into his mouth for using the MDI device 100. The mouthpiece portion 218 has a non-circular cross-section perpendicular to the axis of flow 215 of the mouthpiece portion 218. The axis of flow 214 of the actuator orifice 212 and the axis of flow 215 of the mouthpiece portion 218 may be coaxial relative to each other. In the illustrated embodiment, the axis of flow 214 of the actuator orifice 212 and the axis of flow 215 of the mouthpiece portion 218 intersect with each other such that the actuator orifice 212 and the mouthpiece portion 218 are concentric with respect to each other. In one embodiment, the non circular cross-section of the actuator orifice 212 and the non-circular cross-section of the mouthpiece portion 218 are substantially concentric. The non-circular cross-section of the mouthpiece portion 218 has a non-circular shape which matches the cross-sectional shape of the actuator orifice 212. In other words, the shape of the non-circular cross-section of the actuator orifice 212 is similar to the shape of the non-circular cross-section of the mouthpiece portion 218. The non-circular shape of the mouthpiece portion 218 may include any suitable shape such as a substantially oval shape, a substantially elliptical shape, or a polygonal shape. The present disclosure is not limited by a type of non-circular shape of the cross-section of the mouthpiece portion 218.
FIG. 3 shows further structural details of the actuator orifice 212 and the mouthpiece portion 218. The actuator orifice 212, which includes the orifice portion 226 and the spray cone portion 228, has a non-circular cross-sectional shape. In the illustrated embodiment, the actuator orifice 212 is drawn to show the structural details of the orifice portion 226 and is not drawn to scale. Additionally, in FIG. 3, the actuator orifice 212 is shown as having a substantially oval cross-sectional shape.
Dimensions of the actuator orifice 212 may be defined as per application requirements. In an embodiment particularly useful in dispensing homogeneous solutions, the orifice portion 226 can have a cross-sectional area substantially similar to that of a circular-shaped actuator orifice with a diameter of between 0.2 mm and 0.3 mm. In an embodiment particularly useful in dispensing suspensions of medicament, the orifice portion 226 can have a cross-sectional area substantially similar to that of a circular-shaped actuator orifice with a diameter of between 0.2 mm and 0.6 mm. The substantially oval cross-sectional shape of the orifice portion 226 may be defined by a maximum width“Wi” and a minimum width“W2”. The maximum width“Wi” may be defined as a horizontal expanse of the oval shape and the minimum width“W2” may be defined as a vertical expanse of the oval shape. In some embodiments, the orifice portion 226 has the maximum width“Wi” of about 0.2 mm to about 0.6 mm. However, the present disclosure is not limited by any defined dimensional range of the maximum width“Wi” of the orifice portion 226, and the maximum width“Wi” may vary as per application requirements. In some embodiments, the orifice portion 226 has the minimum width“W2”of about 0.2 mm to about 0.6 mm. However, the present disclosure is not limited by any defined dimensional range of the minimum width“W2” of the orifice portion 226, and the minimum width“W2” may vary as per application requirements.
The mouthpiece portion 218 has a non-circular cross-sectional shape. In the illustrated embodiment, the mouthpiece portion 218 is shown as having a substantially oval cross-sectional shape. The mouthpiece portion 218 has the non-circular cross-section perpendicular to the axis of flow 215 that has a non-circular oval shape matching the cross-sectional shape of the actuator orifice 212. Therefore, cross-sectional dimensions of the actuator orifice 212 and the mouthpiece portion 218 are substantially proportional to each other. In some embodiments, the non-circular oval cross- sections of the mouthpiece portion 218 and the actuator orifice 212 are concentric with each other.
The mouthpiece portion 218 has an inner surface 302 and an outer surface 304. Dimensions of the mouthpiece portion 218 may be defined as per application requirements. The substantially oval cross-sectional shape of the mouthpiece portion 218 may be defined by a maximum inner width“W3” and a minimum inner width“W4”. The maximum inner width“W3” may be defined as a horizontal expanse of the oval shape and the minimum inner width“WV’may be defined as a vertical expanse of the oval shape. In some embodiments, the mouthpiece portion 218 has the maximum inner width “W3” of about 20 mm to about 25 mm. However, the present disclosure is not limited by any defined dimensional range of the maximum inner width“W3”of the mouthpiece portion 218, and the maximum inner width“W3”may vary as per application requirements. In some embodiments, the mouthpiece portion 218 has the minimum inner width“W4” of about 7 mm to about 10 mm. However, the present disclosure is not limited by any defined dimensional range of the minimum inner width “W4” of the mouthpiece portion 218, and the minimum inner width“W4” may vary as per application requirements. In an embodiment, a ratio between the maximum width“Wi” and the maximum inner width“W3” is substantially equal to a ratio between the minimum width“W2” and the minimum inner width“W4” due to the similarity of the cross-sectional shapes of the actuator orifice 212 and the mouthpiece portion 218.
A thickness“T” of the mouthpiece portion 218 is defined between the inner surface 302 and the outer surface 304. The thickness“T” may therefore correspond to a wall thickness of the mouthpiece portion 218. In some embodiments, the thickness“T” of the mouthpiece portion 218 is about 1 mm. However, the present disclosure is not limited to any defined dimensional range of the thickness“T” of the mouthpiece portion 218, and the thickness“T” may vary as per application requirements.
FIG. 4 schematically shows the non-circular oval cross-section of the mouthpiece portion 218 and a matching aerosol spray pattern (i.e. the spray plume) generated through the actuator orifice 212 due to the similarity of cross-sectional shapes of the mouthpiece portion 218 and the actuator orifice 212. Similarity of cross-sectional shapes of the mouthpiece portion 218 and the actuator orifice 212 produces a matching aerosol spray pattern into the mouthpiece portion 218, thus preventing deposition of the fluid on the inner surface 302 of the mouthpiece portion 218 and ensuring a better delivery of the fluid to the user. Such similarity of cross-sectional shapes minimizes occurrences of buccal and tongue deposition. Further, it also reduces possibility of teeth or lips posing as obstacles in path of the fluid being delivered through the actuator orifice 212.
Referring to FIG. 5, another embodiment of present disclosure is illustrated. An actuator orifice 612, which includes an orifice portion 626 and a spray cone portion 628, is shown as having a substantially elliptical cross-sectional shape. Dimensions of the actuator orifice 612 may be defined as per application requirements. The substantially elliptical cross-sectional shape of the orifice portion 626 may be defined by a maximum width“W5” and a minimum width“We”. In the illustrated embodiment of FIG. 5, the maximum width“W5” may be defined as a horizontal expanse of the elliptical shape or a major axis of the elliptical shape. Further, the minimum width "We" may be defined as a vertical expanse of the elliptical shape or a minor axis of the elliptical shape. However, the present disclosure is not limited by any defined dimensional range of the maximum width“W5” of the orifice portion 226, and the maximum width“Wg” may vary as per application requirements. In some embodiments, the orifice portion 612 has the minimum width Wf of about 0.2 mm to about 0.6 mm and a maximum width“W5” of about 0.2 mm to about 0.6 mm.
In the illustrated embodiment, a mouthpiece portion 604 is shown as having a substantially elliptical cross-sectional shape. The mouthpiece portion 604 has an inner surface 606 and an outer surface 608. Dimensions of the mouthpiece portion 604 may be defined as per application requirements. The substantially elliptical cross-sectional shape of the mouthpiece portion 604 may be defined by a maximum inner width“W7” and a minimum inner width Wx . The maximum inner width“W7”may be defined as a horizontal expanse of the elliptical shape or a major axis of the elliptical shape. Further, the minimum inner width Wx may be defined as a vertical expanse of the elliptical shape or a minor axis of the elliptical shape. In some embodiments, the mouthpiece portion 604 has the maximum inner width“W7” of about 20 mm to about 25 mm. In some embodiments, the mouthpiece portion 604 has the minimum inner width“Ws” of about 12 mm to about 20 mm. In an embodiment, the elliptical cross-sectional shape of the actuator orifice 612 is similar to the elliptical cross-sectional shape of the mouthpiece portion 604. Therefore, a ratio between the maximum width “W5” and the maximum inner width“W7” is substantially equal to a ratio between the minimum width “We” and the minimum inner width Wx .
FIG. 6 schematically shows the non-circular elliptical cross-section of the mouthpiece portion 604 and a matching aerosol spray pattern or spray plume generated through the actuator orifice 612 due to similarity of cross-sectional shapes of the mouthpiece portion 604 and the actuator orifice 612. Similarity of cross-sectional shapes of the mouthpiece portion 604 and the actuator orifice 612 produces the matching aerosol spray pattern or spray plume into the mouthpiece portion 604, thus preventing deposition of the fluid on the inner surface 606 of the mouthpiece portion 604 and ensuring a better delivery of the fluid to the user. Such similarity of cross-sectional shapes minimizes occurrences of buccal and tongue deposition. Further, it also reduces possibility of teeth or lips posing as obstacles in path of the fluid being delivered through the actuator orifice 612.
FIG. 7 illustrates another aspect of the present disclosure. A flow chart depicts steps of a method 700 to treat a pulmonary condition in a human patient. At step 702, the method 700 includes providing the MDI device 100. The MDI device 100 includes the actuator housing 106 with the actuator orifice 212 and the mouthpiece portion 218. The actuator orifice 212 has a non-circular cross- section perpendicular to its axis of flow 214. The mouthpiece portion 218 has a non-circular cross- section perpendicular to its axis of flow 215. The non-circular cross-section of the mouthpiece portion 218 has a non-circular shape which matches the cross-sectional shape of the actuator orifice 212.
At step 704, the method 700 includes placing at least a part of the mouthpiece portion 218 in the mouth of the human patient. At step 706, the method 700 further includes actuating the MDI device 100 while inhaling so that an aerosol spray pattern or a spray plume of metered fluid is dispensed from the actuator orifice 212 and ejected through the mouthpiece portion 218. The aerosol spray patern has a non-circular shape that matches the non-circular shape of the cross-section of the mouthpiece portion 218.
Unless otherwise indicated, all numbers expressing feature sizes, amounts, and physical properties used in the specification and claims are to be understood as being modified by the term “about”. Accordingly, unless indicated to the contrary, the numerical parameters set forth in the foregoing specification and attached claims are approximations that can vary depending upon the desired properties sought to be obtained by those skilled in the art utilizing the teachings disclosed herein.
Although specific embodiments have been illustrated and described herein, it will be appreciated by those of ordinary skill in the art that a variety of alternate and/or equivalent implementations can be substituted for the specific embodiments shown and described without departing from the scope of the present disclosure. This application is intended to cover any adaptations or variations of the specific embodiments discussed herein. Therefore, it is intended that this disclosure be limited only by the claims and the equivalents thereof.

Claims

CLAIMS:
1. An actuator housing for a metered dose inhaler device, the actuator housing comprising: a substantially hollow tubular housing portion having a first proximal end and a first distal end;
a base portion formed at the first proximal end of the housing portion;
a nozzle block formed in the base portion, the nozzle block comprising an actuator seat and an actuator orifice in fluid communication with the actuator seat, the actuator orifice operable for dispensing a spray of metered fluid, the actuator orifice further having a non-circular cross-section perpendicular to its axis of flow; and
a substantially hollow mouthpiece portion joined to the housing portion and the base portion, the mouthpiece portion having a second proximal end and a second distal end, the second proximal end being located adjacent to the first proximal end and the second distal end defining a mouthpiece end, the mouthpiece portion further having a non-circular cross-section perpendicular to its axis of flow that has a non-circular shape matching the cross-sectional shape of the actuator orifice so as to produce a matching aerosol spray pattern into the mouthpiece portion.
2. The actuator housing of claim 1, wherein the non-circular cross-section of the actuator orifice is substantially oval.
3. The actuator housing of claim 1, wherein the non-circular cross-section of the mouthpiece is substantially oval.
4. The actuator housing of claim 1, wherein the actuator orifice has a frustoconical configuration defining the axis of flow of the actuator orifice.
5. The actuator housing of claim 1, wherein the non-circular cross-section of the actuator orifice and the non-circular cross-section of the mouthpiece portion are substantially concentric.
6. The actuator housing of claim 1, wherein the actuator orifice has a maximum width of about 0.2 mm to about 0.6 mm, and a minimum width of about 0.2 mm to about 0.6 mm.
7. The actuator housing of claim 1, wherein the mouthpiece portion has a maximum inner width of about 20 mm to about 25 mm, and a minimum inner width of about 7 mm to about 25 mm.
8. The actuator housing of claim 1, wherein a thickness of the mouthpiece portion is about 1 mm .
9. The actuator housing of claim 1, wherein a length of the mouthpiece portion is from about 10 mm to about 25 mm.
10. The actuator housing of claim 1, wherein the nozzle block further comprises a sump region in fluid communication with the actuator seat and the actuator orifice.
11. The actuator housing of claim 1, wherein the nozzle block extends upwardly from the base portion.
12. The actuator housing of claim 1, wherein the nozzle block has a substantially hollow tubular shape.
13. The actuator housing of claim 1, wherein the base portion further comprises a grip section disposed on an outer surface of the base portion.
14. A metered dose inhaler device comprising:
a canister containing a fluid formulated with a medicament, the canister comprising a metering valve and a hollow valve stem extending from the metering valve, the canister being adapted to release a predetermined amount of fluid through the metering valve upon actuation; and
an actuator housing comprising:
a substantially hollow tubular housing portion having a first proximal end and a first distal end;
a base portion formed at the first proximal end of the housing portion;
a nozzle block formed in the base portion, the nozzle block comprising an actuator seat for engaging with the valve stem and an actuator orifice in fluid communication with the actuator seat, the actuator orifice operable for dispensing a spray of the predetermined amount of fluid received from the valve stem, the actuator orifice further having a non-circular cross-section perpendicular to its axis of flow; and
a substantially hollow mouthpiece portion joined to the housing portion and the base portion, the mouthpiece portion having a second proximal end and a second distal end, the second proximal end being located adjacent to the first proximal end and the second distal end defining a mouthpiece end, the mouthpiece portion further having a non-circular cross-section perpendicular to its axis of flow that has a non-circular shape matching the cross-sectional shape of the actuator orifice so as to produce a matching aerosol spray pattern into the mouthpiece portion.
15. The metered dose inhaler of claim 14, wherein the non-circular cross-section of the actuator orifice is substantially oval.
16. The metered dose inhaler of claim 14, wherein the non-circular cross-section of the mouthpiece is substantially oval.
17. The metered dose inhaler of claim 14, wherein the actuator orifice has a frustoconical configuration defining the axis of flow of the actuator orifice.
18. The metered dose inhaler of claim 14, wherein the non-circular cross-section of the actuator orifice and non-circular cross-section of the mouthpiece portion are substantially concentric.
19. The metered dose inhaler of claim 14, wherein the actuator orifice has a maximum width of about 0.2 mm to about 0.6 mm, and a minimum width of about 0.2 mm to about 0.6 mm.
20. The metered dose inhaler of claim 14, wherein the mouthpiece portion has a maximum inner width of about 20 mm to about 25 mm, and a minimum inner width of about 7 mm to about 25 mm.
21. The metered dose inhaler of claim 14, wherein a thickness of the mouthpiece portion is about 1 mm.
22. The metered dose inhaler of claim 14, wherein a length of the mouthpiece portion is from about 10 mm to about 25 mm.
23. The metered dose inhaler of claim 14, wherein the nozzle block further comprises a sump region in fluid communication with the actuator seat and the actuator orifice.
24. The metered dose inhaler of claim 14, wherein the nozzle block extends upwardly from the base portion.
25. The metered dose inhaler of claim 14, wherein the nozzle block has a substantially hollow tubular shape.
26. The metered dose inhaler of claim 14, wherein the base portion further comprises a grip section disposed on an outer surface of the base portion.
PCT/IB2019/059447 2018-11-07 2019-11-04 Actuator housing for inhaler device WO2020095175A1 (en)

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US20070175469A1 (en) * 2005-12-02 2007-08-02 Boehringer Ingelheim International Gmbh, Dispensing device
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WO2017087355A1 (en) * 2015-11-16 2017-05-26 3M Innovative Properties Company An actuator housing for a metered dose inhaler device
WO2017118995A1 (en) * 2016-01-07 2017-07-13 Raval Bhupendra Kantilal An inhaler

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GB2276101A (en) * 1993-03-19 1994-09-21 Csb Moulds Ltd Spray nozzles for pharmaceutical inhalers
WO2001058508A2 (en) * 2000-02-09 2001-08-16 Glaxo Group Limited Actuator nozzle for metered dose inhaler
US20070175469A1 (en) * 2005-12-02 2007-08-02 Boehringer Ingelheim International Gmbh, Dispensing device
WO2009015456A1 (en) * 2007-07-30 2009-02-05 Generex Pharmaceuticals Inc. Pharmaceutical formulation in mixed micellar form and dispenser for oral delivery of agents as a spray
WO2017087355A1 (en) * 2015-11-16 2017-05-26 3M Innovative Properties Company An actuator housing for a metered dose inhaler device
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