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Assignees
Member
Kindeva Drug DeliveryKindeva Drug Delivery is a contract development and manufacturing organization specializing in advanced drug delivery systems including pulmonary, nasal, injectable, transdermal, and intradermal therapies. Services range from formulation and analytical development to commercial-scale, Annex 1-compliant GMP manufacturing across global facilities. The company brings integrated expertise in regulatory strategy, device engineering, process and technology transfer, and quality assurance, with a focus on sustainable solutions such as low-GWP propellants and microneedle patch platforms. Kindeva supports complex, patient-centric, and environmentally optimized therapies from product conception through commercialization.
Kindeva Drug Delivery is a contract development and manufacturing organization specializing in advanced drug delivery systems including pulmonary, nasal, injectable, transdermal, and intradermal therapies. Services range from formulation and analytical development to commercial-scale, Annex 1-compliant GMP manufacturing across global facilities. The company brings integrated expertise in regulatory strategy, device engineering, process and technology transfer, and quality assurance, with a focus on sustainable solutions such as low-GWP propellants and microneedle patch platforms. Kindeva supports complex, patient-centric, and environmentally optimized therapies from product conception through commercialization.
Publication Number
US-11707584-B2
Publication Date
2023-07-25
Expiration Date
Abstract
An inhaler (60) has a breath actuated trigger mechanism (100) reactive to an inhalation flow to trigger the release of a substance to be inhaled. The inhaler (60) has an inspiration flow which is subject to a higher degree of flow governing post-triggering than pre-triggering. This allows the triggering flow rate to be closer to, or even higher than, the governing flow rate of the inhaler.
Core Innovation
The invention provides an inhaler architecture with a breath actuated trigger mechanism reactive to an inhalation flow to trigger the release of a substance to be inhaled into the inhalation flow. The inhaler includes a first fluid flow path within the inhaler carrying part of the inhalation flow and a flow governor arranged to govern inhalation flow through the first fluid flow path.
The inhaler further includes a second fluid flow path within the inhaler carrying part of the inhalation flow, where the second fluid flow path bypasses the flow governor. Triggering of the trigger mechanism reduces or blocks flow through the second fluid flow path, and the second flow path is at least partially blocked by a part of the trigger mechanism after triggering.
Multiple embodiments are described, including vane-driven toggle release arrangements in which a trigger mechanism and valve-seat closure block the bypass flow path after triggering, and a flow governor configuration described as a collapsible silicone-tube Venturi/Bernoulli-driven flow governor with bistability and residual flow. Other embodiments include a vane actuating a pivoting flow-governor flap to switch governing flow area, and rocker/catch/vane arrangements in which a flap governor is governed only after firing.
Claims Coverage
The independent claim clm-00001 covers an inhaler having five core inventive elements: a breath actuated trigger mechanism for release into an inhalation flow, a first fluid flow path governed by a flow governor, a second fluid flow path bypassing the flow governor, and trigger-driven reduction or blocking of the second path after triggering. The dependent claims refine the independent claim by adding specific actuation-member/valve-seat relationships, structural placement, and inlet/outlet geometry constraints.
Breath actuated trigger release into inhalation flow with post-trigger bypass blocking
A breath actuated trigger mechanism reactive to an inhalation flow triggers release of a substance to be inhaled into the inhalation flow; triggering reduces or blocks flow through a second fluid flow path, and the second flow path is at least partially blocked by a part of the trigger mechanism after triggering.
Flow governor governing through a first fluid flow path
A flow governor is arranged to govern inhalation flow through a first fluid flow path within the inhaler carrying part of the inhalation flow.
Bypassing second fluid flow path reduced by triggering
A second fluid flow path within the inhaler carries part of the inhalation flow and bypasses the flow governor, with triggering causing reduction or blocking of flow through the second fluid flow path.
Actuation member in pre-triggered and post-triggered positions to block the second flow path
A trigger mechanism includes an actuation member holding a canister in a pre-triggered position and, when triggered, moves to a post-triggered position to at least partially block the second flow path.
Valve member and valve seat spaced apart pre-trigger and abutting post-trigger
The actuation member defines a valve member and the inhaler has a valve seat for the second flow path, with the valve member spaced apart in the pre-triggered position and abutting the valve seat in the post-triggered position.
Vane toggle between primed and post-triggered conditions
A toggle mechanism includes a vane positioned in the inhalation flow that moves the toggle between a primed condition maintaining the actuation member in the pre-triggered position and a post-triggered condition permitting movement of the actuation member.
Trigger mechanism positioned downstream of the second flow path
The trigger mechanism is positioned downstream of the second flow path.
First and second flow inlets on opposite sides of the flow outlet
The first and second flow inlets are on opposite sides of the flow outlet.
Across the identified independent and dependent claim coverage, the inventive concept centers on governing flow through a first fluid flow path with a flow governor while a second bypass path is reduced or blocked by the breath-actuated trigger mechanism after triggering. The claim refinements specify particular trigger mechanisms via actuation-member/valve-seat interactions, vane-based toggle primed/post-triggered control, positional relationships of the trigger relative to the second flow path, and inlet/outlet geometry constraints.
Stated Advantages
Enables closer to or greater than GFR triggering reliability by transitioning from bypassed flow to more fully governed airflow after dose release.
Documented Applications
Not explicitly described in patent.
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