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EP4587740A1 - Soupape de régulation de débit de rétroaction haptique - Google Patents

Soupape de régulation de débit de rétroaction haptique

Info

Publication number
EP4587740A1
EP4587740A1 EP23864198.9A EP23864198A EP4587740A1 EP 4587740 A1 EP4587740 A1 EP 4587740A1 EP 23864198 A EP23864198 A EP 23864198A EP 4587740 A1 EP4587740 A1 EP 4587740A1
Authority
EP
European Patent Office
Prior art keywords
flow rate
control valve
rate control
flexible closure
flexible
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP23864198.9A
Other languages
German (de)
English (en)
Inventor
David Mark Douglas HODGSON
Sara FEDULLO
Brandon Alexander BEACH
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.)
Hollo Medical Inc
Original Assignee
Hollo Medical 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 Hollo Medical Inc filed Critical Hollo Medical Inc
Publication of EP4587740A1 publication Critical patent/EP4587740A1/fr
Pending 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
    • A61M15/00—Inhalators
    • A61M15/0001—Details of inhalators; Constructional features thereof
    • A61M15/002—Details of inhalators; Constructional features thereof with air flow regulating means
    • 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
    • A61M15/0013—Details of inhalators; Constructional features thereof with inhalation check valves
    • A61M15/0015—Details of inhalators; Constructional features thereof with inhalation check valves located upstream of the dispenser, i.e. not traversed by the product
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
    • F16K15/00—Check valves
    • F16K15/14—Check valves with flexible valve members
    • F16K15/1401—Check valves with flexible valve members having a plurality of independent valve members
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
    • F16K15/00—Check valves
    • F16K15/14—Check valves with flexible valve members
    • F16K15/16—Check valves with flexible valve members with tongue-shaped laminae
    • F—MECHANICAL ENGINEERING; LIGHTING; HEATING; WEAPONS; BLASTING
    • F16—ENGINEERING ELEMENTS AND UNITS; GENERAL MEASURES FOR PRODUCING AND MAINTAINING EFFECTIVE FUNCTIONING OF MACHINES OR INSTALLATIONS; THERMAL INSULATION IN GENERAL
    • F16K—VALVES; TAPS; COCKS; ACTUATING-FLOATS; DEVICES FOR VENTING OR AERATING
    • F16K37/00—Special means in or on valves or other cut-off apparatus for indicating or recording operation thereof, or for enabling an alarm to be given
    • F16K37/0008—Mechanical means
    • 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
    • A61M15/0018—Details of inhalators; Constructional features thereof with exhalation check 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
    • A61M15/0086—Inhalation chambers
    • A61M15/0088—Inhalation chambers with variable volume
    • 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
    • A61M15/009—Inhalators using medicine packages with incorporated spraying means, e.g. aerosol cans
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/582—Means for facilitating use, e.g. by people with impaired vision by tactile feedback

Definitions

  • the present invention relates to flow rate control valves and more specifically to flow rate control valves with a haptic feedback mechanism.
  • An example inhaler may comprise, for example, a plastic holder forming an inlet for a drug canister and a mouthpiece.
  • the drug canister may comprise, for example a propellant with a drug suspension, and a metering valve that is connected to a nozzle for expelling the aerosol drug from the cannister.
  • the cannister may be inserted into the inlet of the plastic holder such that the nozzle of the cannister aligns with the mouthpiece of the plastic holder.
  • a flow rate control valve may be used to encourage users inhale at a desired flow rate or within a range of desired flow rates.
  • a desirable inspiratory flow rate for an inhaler may be less than about 60 LPM, less than about 30LPM, or less than about 15LPM.
  • a flow rate above a desirable threshold may reduce distal lung dose delivery by about 150% to about 300%, and may cause the dose to impact areas other than the lungs, for example the mouth and throat.
  • a flow rate control valve may achieve flow control to a desired range through conversion of flow energy into a flexible closure resonant vibration.
  • the flow rate control valve may be used in connection with a spacer and/or an inhaler to prompt a user to adjust their inhalation flow rate to within an optimal range.
  • a flow rate control valve according to the present disclosure may be used in connection with a spacer or inhaler to provide haptic feedback to users to control flow rate.
  • the haptic feedback or vibration may provide a warning signal that the user’s inspiration flow rate is too high and may prompt the user to correct their inhalation flow rate to within a range where the vibration ceases.
  • the present disclosure provides a housing defining a cross- sectional area for fluid flow, and, a flap connected to the housing and comprising a spring constant of from about 25 N/m to about 650 N/m.
  • a fluid flow rate from about 15 LPM to about 60 LPM is sufficient to induce the flap to vibrate.
  • Figures 1A and 1 B illustrate perspective views of example flow rate control valves according to embodiments of this disclosure.
  • Figure 2 illustrate a front view of an example flow rate control valve according to embodiments of this disclosure.
  • Figure 3A illustrates a flow rate control valve with a flexible closure in an open position according to embodiments of this disclosure.
  • Figure 3B illustrates a flow rate control valve with a flexible closure in a vibration position according to embodiments of this disclosure.
  • Figure 8C illustrates the exemplary holding chamber in a collapsed position, where the chamber is collapsed parallel to the airflow.
  • Figure 9B illustrates a top half of a device as disclosed herein comprising a chamber with expanded bellows.
  • Figure 10A illustrates an open inhaler port on an expandable bellow chamber, in the expanded position, according to embodiments described herein.
  • Figure 11 illustrates a cross-sectional side view of an inhaler port with and without an inhaler, wherein the port is on a device with expandable bellows as described in this disclosure.
  • Figure 14B illustrates an example flow rate control valve connected to an inhaler according to embodiments of this disclosure.
  • Figures 15 illustrate a perspective and cross-sectional view of an example flow rate control valve according to embodiments of this disclosure.
  • the present disclosure provides a flow rate control valve that includes a housing defining a cross-sectional area for fluid flow, and a flexible closure that includes a first end connected to the housing and a second end biased in an open position and moveable between i) the open position, and ii) a vibration position. Fluid flowing through the housing moves the second end from the open position to the vibration position when the fluid flow rate is at a vibration-inducing flow rate.
  • fluid as discussed herein comprises gaseous fluid, for example gases and aerosols.
  • the flexible closure may be integrally formed with a housing or formed separately and attached to a housing at one end.
  • the flexible closure may be made of a flexible material, such as for example plastic or silicone.
  • the flexible closure may be made of a rigid material but constructed such that it is thin enough to provide the desired flexibility and vibration.
  • the flexible closure may comprise a rigid plate, a conventional hinge, and an externally attached spring tuned to achieve the desired vibration.
  • the flexible closure may function similar to a spring.
  • the flexible closure may be sized and shaped to have a spring constant of from about 25 N/m to about 650 N/m, for example about 50N/m to about 500N/m, or from about 100 N/m to about 300 N/m, for example from about 150 N/m to 250 N/m, or from about 160N/m to about 200 N/m.
  • the spring constant k of the flexible closure may be determined for example by the thickness, length and elastic modulus of the material of the flexible closure.
  • the spring constant may be used to dictate the balance of forces needed between the inspiratory pressure and the balancing force of the flexible closure such that the flexible closure resonates in phase with the pressure forces acting against it.
  • the orifice plate may be formed in a single piece with a cut-out or hole defining a narrowed cross- sectional area wherein when the flexible closure is in a closed position, the open area for fluid flow is substantially sealed.
  • multiple contact surfaces may be connected to one another to form an orifice plate with an open area for fluid flow that is substantially sealed when the flexible closure is in a closed position.
  • each of the flexible closures When more than one flexible closure is sealed, the closed position of each of the flexible closures may allow for a gap for fluid to flow between the side edges of the flexible closures and the vertical contact surfaces of the orifice plate.
  • a gap 110b may be formed between the side edges of each of the flexible closures and the middle column of the orifice plate.
  • the orifice plate may be formed in a single piece with cut-out or holes defining narrowed cross-sectional areas wherein when the flexible closures are in a closed position, the open area for fluid flow is substantially sealed other than the small gaps formed between the vertical contact surfaces and the edges of the flexible closures.
  • the 3D printed chambers represented a holding chamber in an un-collapsed open position (Figure 8A), and two chambers collapsed to 50% volume of the non-collapsed chamber. The latter were created as follows: the first represented a chamber collapsed perpendicular to airflow ( Figure 8B), and the second represented a chamber collapsed parallel to airflow (Figure 8C).
  • Each chamber was placed on top of an aluminum- based deposition sheet, intended to collect the aerosolized particles at impaction.
  • the aerosolized deodorant was sprayed through the three chambers and at completion, each element of the experimental set up was weighed to determine the total mass that had been collected inside the chambers versus the spray that impacted the deposition sheet. Summary results of the experiment are shown below in Table 2 below. Table 2: Summary table of results from dry particle deposition testing
  • Figures 9A and 9B illustrate an example of expandable bellows that expand in a direction that is perpendicular to the fluid flow path.
  • Figure 9A illustrates the expandable bellows 950 in a closed or non-expanded position 952.
  • Figure 9B illustrates a top half of the device with the bellows 950 in the expanded position 954 (bottom half omitted but may be symmetrically expanded or asymmetrical expanded).
  • a truncated cone or funnel shape of the expanded expandable bellows in a direction perpendicular to the flow of fluid, for example as shown in Figure 9B, may further provide central dilation to enable particle expansion, and a slow funneling of particles into the mouthpiece.
  • the bellows comprise angled ringed portions connected by living hinges to form the chamber.
  • the angled rings can rotate approximately 90 degrees from a folded or collapsed position to an open or expanded position and function to reduce the size of the whole device by a factor of 5, in this example, when folded compared to when open.
  • a rigid center structure is also provided to produce an outward force to prevent unfolding.
  • the port in the active or open position may be open with rib-like projections to allow the insertion and retention of an aerosol generating device, and in the closed position, may be entirely sealed through the collapse of the device’s volume expanding bellows.
  • the collapse of opposing bellows is configured to cause the edge of the bellows to rotate about 90 degrees and form a seal with the edge of an opposing below such as to help prevent dirt from entering the port when in the closed position.
  • the port is simultaneously open as the bellow edges move away from the port hole.
  • the port seals to help prevent debris from collecting and contaminating the chamber, for example, when not in use.
  • FIG. 11 illustrates a cross-sectional side view of an inhaler port with and without an inhaler, wherein the port is on a device with expandable bellows as described in this disclosure. Additional mechanisms, such as fins shown in Figure 11 for example, can be added to the expandable bellows adjacent to the inhaler port. By placing, for example, 4 additional fins 1144 (2 top, 2 bottom shown in Figure 11), it may be possible to cradle the inhaler when it is in its functional position.
  • More or less fins or other retention means may be used in other examples and with any flow rate control valve as described in this disclosure.
  • the inhaler retention features as disclosed herein may enable more robust accommodation and retention of a variety of inhalers with differing mouthpiece profiles. Further, it may also be feasible for the inhaler cradle fins to serve as the inhaler port closure mechanism to prevent dirt and debris from entering the device.
  • the inhaler port may replace the base of a conventional inhaler “boot” or housing which enables the canister to be actuated directly into the chamber without needing the inhaler housing.
  • boot or housing which enables the canister to be actuated directly into the chamber without needing the inhaler housing.
  • the benefit of this may be particularly seen in hospital settings where the sharing of the same canister across multiple devices/patients may be beneficial. For example, a canister with 120 doses, and an inpatient that only requires acute administration of 8-12 doses, may be able to share the same canister. In the outpatient setting, the canister could feasibly be stored alongside the chamber when not in use, via a standard c-shaped clip.
  • the flow rate control valve according to any of the embodiments disclosed herein may be constructed with the addition of a nasal occlusion face mask.
  • Presently available holding chamber facemasks known in the prior art rely on a design which forms a triangular seal from the bridge of the nose to the lateral edges of the chin. This is known to be variably effective due to the unpredictable facial anatomy that needs to be accommodated, for being intrusive and frightening to some patients, for increasing the dead space, or air that first needs to be inhaled into the lungs prior to the active drug, resulting in lower efficacy with smaller tidal volumes, and resulting in facial discoloration due to exposure of inhaled corticosteroids to the skin unnecessarily.
  • the nasal occlusion facemask according this disclosure may accommodate all facial anatomies with a single design, utilize only the optimal route of drug inhalation, and may minimize the material wasted as these parts are used in extremely high volumes. There is further the opportunity to use the nasal occlusion design as disclosed herein to customize accommodations for unique facial geometries such as facial deformities, or those with additional medical equipment use (for example, with nasal cannulas in place).
  • Figure 12A depicts an example nasal occlusion face mask according to this disclosure which may be used with any flow rate control valve or feature as previously discussed in this disclosure.
  • Figure 12B depicts an example nasal occlusion face mask associated with a flow rate control valve 1210 and collapsible bellows chamber 1230.
  • the nasal occlusion face mask comprises an over the lip mask 1250, which utilizes the lips as a gasket to create an airtight seal, along with a contoured surface 1252 designed to bilaterally occlude the narus.
  • the mouth portion of the mask may accommodate for example, the 95%ile of mouths, and any variation in height from the mouth to the tip of the nose can be accommodated through an adjustable height, for example ratchet style, of the nasal occlusion surface.
  • This ratchet style adjustment 1254 shown in Figure 12A is further depicted in Figure 13 in its various heights.
  • the ratchet style adjustment can be used either manually using height adjustment nuts disposed thereon, or during device use when a seal is formed on the face via a cam-sliding mechanism.
  • a single device with a ratcheting nasal occlusion plate can supplant the need for various different sizes of facemasks, which require substantial pressure to form a seal over a large surface area that is not involved with gas exchange at all, nor anatomically reliable for a universal fit.
  • the nasal occlusion face mask may be adapted to accommodate atypical facial geometries, for example due to deformity (i.e. cleft lip), or obstructions for example the use of nasal cannulas by way of hospital oxygenation.
  • atypical facial geometries for example due to deformity (i.e. cleft lip), or obstructions for example the use of nasal cannulas by way of hospital oxygenation.
  • the use of facial scanning, and personalized 3D printed nasal occlusion masks may also be created. This may enable the ability to not only adapt the nasal occlusion plate, but to enhance the mouth mask fit for those with deformities or obstructions around the mouth.

Landscapes

  • Engineering & Computer Science (AREA)
  • General Engineering & Computer Science (AREA)
  • Health & Medical Sciences (AREA)
  • Mechanical Engineering (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pulmonology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)

Abstract

L'invention concerne une soupape de régulation de débit comprenant une fermeture souple. La fermeture souple étant mobile entre une position ouverte et une position de vibration. La position de vibration fournissant une rétroaction haptique à un utilisateur pour signaler un débit inspiratoire supérieur à un débit souhaité. La soupape de régulation de débit peut être utilisée en liaison avec un inhalateur ou une entretoise de dose mesurée sous pression pour fournir, par exemple, une inspiration plus longue, plus lente et constamment contrôlée par restriction d'écoulement et conversion de puissance d'écoulement en un mouvement vibratoire.
EP23864198.9A 2022-09-12 2023-09-08 Soupape de régulation de débit de rétroaction haptique Pending EP4587740A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202263405551P 2022-09-12 2022-09-12
PCT/CA2023/051198 WO2024055101A1 (fr) 2022-09-12 2023-09-08 Soupape de régulation de débit de rétroaction haptique

Publications (1)

Publication Number Publication Date
EP4587740A1 true EP4587740A1 (fr) 2025-07-23

Family

ID=90273998

Family Applications (1)

Application Number Title Priority Date Filing Date
EP23864198.9A Pending EP4587740A1 (fr) 2022-09-12 2023-09-08 Soupape de régulation de débit de rétroaction haptique

Country Status (3)

Country Link
EP (1) EP4587740A1 (fr)
CA (1) CA3263867A1 (fr)
WO (1) WO2024055101A1 (fr)

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5042467A (en) * 1990-03-28 1991-08-27 Trudell Medical Medication inhaler with fitting having a sonic signalling device
US5483954A (en) * 1994-06-10 1996-01-16 Mecikalski; Mark B. Inhaler and medicated package
US20110232636A1 (en) * 2008-12-18 2011-09-29 Koninklijke Philips Electronics, N.V. Valved holding chamber and mask therefor
CA3096365C (fr) * 2011-06-06 2022-04-19 Trudell Medical International Dispositif a pression expiratoire positive oscillante
WO2017199215A1 (fr) * 2016-05-19 2017-11-23 Trudell Medical International Chambre de retenue à valve intelligente
JP7093353B2 (ja) * 2016-12-09 2022-06-29 トゥルーデル メディカル インターナショナル スマートネブライザ

Also Published As

Publication number Publication date
CA3263867A1 (fr) 2024-03-21
WO2024055101A1 (fr) 2024-03-21

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