Flow governors for use in medicinal inhalers
Inventors
Guion, Romain U. G. • Blatchford, Christopher G. • COTTENDEN, DAVID J. • McDerment, Iain G. • Groombridge, Christopher B. J. • Hodson, Peter D. • BUNTING, JOHN P. • Stuart, Adam J. • CALCUTT, SIMON L. • WILLIS, STEPHANIE • PITSON, STEPHEN
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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-11376378-B2
Publication Date
2022-07-05
Expiration Date
Abstract
A flow governor for use in a medicinal inhaler. The flow governor can include (i) a tubular element that defines at least a portion of an air flow path, the tubular element comprising at least one flexible wall configured to flex inwardly in response to an air flow in the air flow path; and (ii) an internal support structure, located within the tubular element and configured to preserve at least a predetermined cross-sectional area of the air flow path within the tubular element when the at least one flexible wall of the tubular element flexes inwardly.
Core Innovation
The invention relates to a flow governor for use in a medicinal inhaler. The flow governor includes a tubular element that defines at least a portion of an air flow path and has at least one flexible wall configured to flex inwardly in response to air flow in the air flow path.
To preserve a governed airflow characteristic during inward flexing, the flow governor includes an internal support structure located within the tubular element. The internal support structure is configured to preserve at least a predetermined cross-sectional area of the air flow path within the tubular element when the at least one flexible wall flexes inwardly, and the predetermined cross-sectional area includes a cross-sectional area of space between the tubular element and the internal support structure.
The internal support structure includes a hollow pillar defining a lumen. The configurations support dynamic, pressure-drop-dependent variable resistance that is lower at low pressure drop and higher upon collapse, thereby governing an inspiratory flow rate while reducing inter- and intra-patient variability and avoiding bulky spacers.
The disclosure further describes medicinal inhaler arrangements with dedicated air-flow paths and sealing covers or skirt seals, together with flow governor assemblies having a housing, optional constriction or venturi sections, and sensor conduits, as well as pressure sensing and breath-actuation concepts using upstream and downstream pressure sensing and inspiration/exhalation direction discrimination.
Claims Coverage
The document includes one independent claim. The independent claim contains three inventive features centred on a flexible tubular element, an internal support structure that preserves a predetermined cross-sectional area during inward flexing, and a hollow pillar with a lumen.
Flexible tubular element with inwardly flexing wall to define air flow path
A tubular element defines at least a portion of an air flow path and includes at least one flexible wall configured to flex inwardly in response to air flow in the air flow path.
Internal support structure preserving predetermined cross-sectional area during inward flexing
An internal support structure located within the tubular element is configured to preserve at least a predetermined cross-sectional area of the air flow path within the tubular element when the at least one flexible wall of the tubular element flexes inwardly, wherein the predetermined cross-sectional area includes a cross-sectional area of space between the tubular element and the internal support structure.
Hollow pillar internal support with lumen
The internal support structure includes a hollow pillar defining a lumen therein.
Overall, the claim coverage protects a flow governor architecture that combines a flexible tubular element that flexes inwardly with an internal support structure that preserves a predetermined effective cross-sectional area during collapse, explicitly including space between the tubular element and the internal support structure, and a hollow pillar defining a lumen.
Stated Advantages
Creates dynamic, pressure-drop-dependent variable resistance with lower resistance at low pressure drop and higher resistance upon collapse.
Better controls inspiratory flow rate while reducing inter- and intra-patient variability.
Avoids bulky spacers.
Documented Applications
Use in a medicinal inhaler, including a breath-actuated inhaler and a pressurised metered dose inhaler (pMDI) context as described in the disclosure summary.
Flow governor assemblies with housing, optionally including venturi constriction sections and sensor conduits, as part of a medicinal inhaler arrangement as described.
Use of pressure sensing and breath-actuation concepts employing upstream and downstream pressure sensing and inspiration/exhalation direction discrimination as described in the disclosure summary.
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