Collapsible, disposable medication inhalation spacer and method

Inventors

Hyde, JoelStrickland, JamesJohnson, Jennifer

Assignees

Thayer Medical Corp

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Publication Number

US-11638792-B2

Patent

Publication Date

2023-05-02

Expiration Date


Abstract

A medication inhalation apparatus preferably formed of a single, unitary sheet of stock, includes an outer housing, movable between collapsed and expanded states, encompassing a first volume. An inner housing within the outer housing encompasses an inner or second volume. An inhaler opening to the first volume is within a wall of the outer housing at a first location. A mouth opening to the inner volume is within a wall of the outer housing and the inner housing at a second location. A one-way inhalation valve connecting the first volume and the inner volume is within a wall of the inner housing. A one-way exhalation valve connecting the inner volume and the exterior of the outer housing is within a wall of the outer housing and inner housing at a third location. The valve preferably includes an elongated spring body formed of a semi-pliant material with a strength and rigidity providing limited flexibility. A first separation is perpendicular to the elongate axis of the spring body, and extends from a first edge of the spring body across at least a portion of a width of the spring body. A second separation perpendicular to the elongate axis of the spring body extends from a second edge of the spring body across at least a portion of the width of the spring body.

Core Innovation

The described invention relates to a disposable, collapsible pop-up medication inhalation spacer/valved holding chamber for use with a metered dose inhaler (MDI). In an expanded state, the apparatus defines a first volume adapted to receive a plume of medication particles ejected by an MDI inhaler and a second volume within the outer housing adapted to be in fluid communication with a user mouth opening. The outer housing and an inner housing are collapsible into a substantially flat configuration and expandable to form the first and second volumes.

The invention provides one-way valving to direct airflow during use, including a one-way inhalation valve connecting the first volume and the second volume and a one-way exhalation valve connecting the second volume to an exterior of the outer housing. The inhalation valve comprises a valve flap with spring return, where the valve flap includes a spring body formed of paperboard material with an elongate axis. The spring body includes separations and a living hinge and an uncut section positioned to prevent the flow of gas through a valve opening.

A further aspect is the use of paperboard-like and other non-plastic valving and sealing implementations, including materials such as paperboard/membranes and an elongated semi-pliant spring body with separations and living hinges and uncut gas-blocking sections, to improve robustness and reduce manufacturing/adhesion complexity versus prior plastic valves. The apparatus is expanded manually by folding and popping along scored lines and includes embodiments with specific inner-flap panel and adhesive attachment patterns, receded corners to reduce backflow, and optional protective or alternate hinge and valve-flap layouts, while remaining collapsible and disposable. Test results described indicate reduced dose loss with incoordination with the subject disposable device versus a non-disposable plastic Aerochamber and comparable performance to the disposable LiteAire, while enabling simpler unitary-sheet valve construction.

Claims Coverage

The partial content includes six independent claims: clm-00001, clm-00006, clm-00008 (method), clm-00009 (method), clm-00010, clm-00012, and one additional method claim clm-00017. Across the independent claims, the coverage is centered on collapsible outer and inner paperboard-like structures that create first and second volumes for medication particle flow from an MDI to a user mouth, combined with one-way inhalation and exhalation valves, and a specific valve flap spring-return construction using separations, a living hinge, and an uncut gas-blocking section.

Collapsible outer and inner volumes with one-way inhalation and exhalation valves

An outer housing collapsible into a substantially flat configuration and expandable to define a first volume adapted to receive a plume of medication particles ejected by an MDI inhaler, and a fully contained inner housing also collapsible into a substantially flat configuration within the outer housing and expandable to define a second volume; a first opening accommodating a mouthpiece of the MDI inhaler and a user mouth opening in fluid communication with the second volume; a one-way inhalation valve connecting the first volume and the second volume comprising a valve flap with spring return; and a one-way exhalation valve connecting the second volume to an exterior of the outer housing, wherein in an expanded state gas is flowable from the MDI inhaler to the first volume, from the first volume to the second volume, and from the second volume to the mouth of a user.

Paperboard spring-body valve flap with living hinge and uncut gas-blocking section

A valve flap with spring return wherein the valve flap includes a spring body formed of a paperboard material with an elongate axis, a first separation perpendicular to the elongate axis extending across at least a portion of a width of the spring body, a second separation perpendicular to the elongate axis extending across at least a portion of a width of the spring body, a living hinge formed in the spring body and located a spaced distance from the first and second separations, and an uncut section located in the spaced distance between the living hinge and the first and second separations, the uncut section positionable to prevent the flow of gas through a valve opening.

Edge affixed inner flap defining second volume and valve placement on inner flap

An inner flap located within the outer housing and expandable to define a second volume within the outer housing wherein an edge panel of the inner flap is affixed to a portion of the outer housing to secure the second volume; a second opening formed through a wall of an outer panel of the inner flap to form a user mouth opening in fluid communication with the second volume; a one-way inhalation valve located within a central panel of the inner flap connecting the first volume and the second volume, wherein the inhalation valve comprises a valve flap with spring return having the paperboard spring-body, separations, living hinge, and uncut section; and a one-way exhalation valve located within an outer panel of the inner flap in a second location and the wall of the outer housing, connecting the second volume and an exterior of the outer housing.

Manually expanding collapsible apparatus to force panels perpendicular and insert MDI mouthpiece

Manually pressing a pair of opposite sidewall panels on the outer housing towards one another, whereby to force the opposite sidewall panels into positions approximately perpendicular to a top and bottom panel of the outer housing; and inserting a mouthpiece of an MDI inhaler into an inhaler opening in the outer housing, in an expansion method for a medication inhalation apparatus having an outer housing and a fully contained inner housing defining first and second volumes and including a one-way inhalation valve comprising a valve flap with spring return having paperboard spring-body separations, living hinge, and an uncut section, and a one-way exhalation valve venting to the exterior.

Collapsed-state airtight outer housing and inner flap with fluid communication and one-way valves

Providing, in the collapsed state, the medication inhalation apparatus having an outer housing and an inner flap substantially airtight when expanded, an inhaler opening at least partially within a first sidewall of the outer housing, a mouth opening within a second sidewall of the outer housing, a one-way inhalation valve positioned within a sidewall of the inner flap, and a one-way exhalation valve positioned within the second sidewall of the outer housing; pressing a pair of opposite sidewall panels on the outer housing; and manually expanding the outer housing and inner flap to create a first volume encompassed by the outer housing and a second volume encompassed by the inner flap and the outer housing, wherein the inhaler opening is in fluid communication with the first volume, the mouth opening is in fluid communication with the second volume, the inhalation valve connects the first volume and the second volume, the exhalation valve connects the second volume and the exterior of the outer housing, and gas is flowable from the inhaler to the first volume, from the first volume to the second volume, and from the second volume to the mouth of a patient.

Paperboard outer housing and inner barrier delineating first and second volumes; unitary-sheet construction

An outer housing formed of paperboard movable between a collapsed state and an expanded state encompassing a first volume; an inner barrier formed of paperboard positioned within the outer housing together with a mouth opening end of the outer housing delineating a second volume; an inhaler opening at least partially within a wall of the outer housing in fluid communication with the first volume with an MDI mouthpiece insertable therein; a mouth opening positioned within the second wall of the outer housing in fluid communication with the second volume; a one-way inhalation valve positioned within a wall of the inner barrier connecting the first volume and the second volume, wherein the inhalation valve is formed from the inner barrier and comprises a valve flap with spring return having a paperboard spring body with first and second separations, a living hinge, and an uncut section positionable to prevent flow of gas through a valve opening; and a one-way exhalation valve positioned within the second wall of the outer housing and the inner barrier connecting the second volume and the exterior of the outer housing, wherein in an expanded state gas is flowable from the metered dose inhaler to the first volume, from the first volume to the second volume, and from the second volume to the mouth of a user, wherein the apparatus is formed from a single, unitary sheet of stock.

Inner flap panels connected along straight scored fold lines

An inner flap located within the outer housing and, together with the outer housing, expandable to define a second volume wherein the inner flap includes panels connected to one another along straight scored fold lines; a first opening through a first wall of the outer housing accommodating a mouthpiece of the MDI inhaler in fluid communication with the first volume; a second opening through the second wall of the outer housing forming a user mouth opening in fluid communication with the second volume; a one-way inhalation valve located within the inner flap connecting the first volume and the second volume, wherein the inhalation valve comprises a valve flap with spring return having a paperboard spring body with first and second separations, a living hinge, and an uncut section positionable to prevent the flow of gas through a valve opening; and a one-way exhalation valve connecting the second volume to an exterior of the outer housing, wherein in an expanded state gas is flowable from a connected MDI inhaler to the first volume, from the first volume to the second volume, and from the second volume to the mouth of a user.

Manual pressing and insertion for scored-fold inner flap expansion method

A method of expanding a medication inhalation apparatus from an initially flat, collapsed state to an expanded state, wherein the apparatus comprises an outer housing collapsible into a substantially flat configuration and expandable to define a first volume, and an inner flap located within the outer housing and expandable with panels connected along straight scored fold lines to define a second volume; a first opening accommodating a mouthpiece of the MDI inhaler in fluid communication with the first volume; a second opening adapted to form a user mouth opening in fluid communication with the second volume; a one-way inhalation valve located within the inner flap connecting the first volume and the second volume, wherein the inhalation valve comprises a valve flap with spring return having a paperboard spring body with first and second separations, a living hinge, and an uncut section positionable to prevent flow of gas through a valve opening; and a one-way exhalation valve connecting the inner volume and an exterior of the outer housing or connecting the second volume and an exterior of the outer housing; and the steps of manually pressing a pair of opposite sidewall panels on the outer housing towards one another to force the opposite sidewall panels into positions approximately perpendicular to a top and bottom panel of the outer housing, and inserting the mouthpiece of the MDI inhaler into the inhaler opening in the outer housing.

Across the independent claims, the document covers an MDI medication inhalation apparatus and expansion methods that use collapsible outer and inner paperboard-like structures defining first and second volumes, fluidly connect those volumes through one-way inhalation and exhalation valves, and implement the inhalation valve as a valve flap with spring return having paperboard spring-body separations, living hinge, and an uncut section positionable to prevent gas flow through a valve opening. Additional independent claim coverage specifies collapsible and airtight expanded operation, manual expansion by pressing opposite sidewall panels into approximately perpendicular positions, insertion of the MDI mouthpiece, and unitary-sheet construction in one apparatus claim.

Stated Advantages

Improves robustness.

Reduces manufacturing/adhesion complexity versus prior plastic valves.

Reduced dose loss with incoordination versus a non-disposable plastic Aerochamber.

Comparable performance to the disposable LiteAire.

Simpler unitary-sheet valve construction.

Documented Applications

Used as a disposable medication inhalation spacer/valved holding chamber for inhalation of medication from an MDI inhaler.

Used to vent exhaled air to the exterior via a one-way exhalation valve.

Evaluated in tests for device efficiency including reduced dose loss with incoordination and measured dose outcomes (total emitted dose, coarse particle dose, fine particle dose).

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