Hollow microneedle arrays
Inventors
Gonzalez, Bernard A. • Burton, Scott A. • Hu, Jia • Ng, Chin-Yee • Simmers, Ryan Patrick • Gilbert, Thomas J. • Burke, Sean M. • Harkins, Robert A. • Schleif, Larry A.
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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-11103685-B2
Publication Date
2021-08-31
Expiration Date
Abstract
The present disclosure relates to apparatus, assemblies, combinations, and methods for infusing fluids by hollow microneedles.
Core Innovation
The invention provides an apparatus and method that displaces a microneedle array in a direction perpendicular to a first major surface of an applicator, while the first major surface comprises the microneedle array. The apparatus includes a drug cartridge having an openable end sealed by a septum and a piston in sliding and sealing relationship with interior walls of a tubular member. A first stored energy device is actuatable to apply force to the applicator to accelerate the applicator generally normal to the first major surface to drive the microneedle array into a desired condition of use.
The invention further provides automatic access to the sealed drug cartridge by a second stored energy device that automatically opens the openable end. The second stored energy device establishes fluid communication between the openable end and the microneedle array via a pathway passing through a manifold carrier fixedly attached to the microneedle array. The actuated second stored energy device includes a spring member that moves the piston relative to the housing so that fluid is forced through the openable end, the pathway, and into the microneedle array.
The housing supports the applicator and the drug cartridge and includes an actuator for actuating the first and second stored energy devices. The drug cartridge, the applicator, and the microneedle array are arranged so that the openable end and the pathway are in fluid communication when opened, enabling forcing of fluid from the drug cartridge into the microneedle array without reliance on user-applied force.
Claims Coverage
The independent claim recites a method and an apparatus having a coordinated sequence: (i) accelerating an applicator carrying a microneedle array perpendicular to a major surface, (ii) opening a septum-sealed drug cartridge to establish fluid communication through a pathway and manifold carrier, and (iii) forcing fluid from the cartridge through the openable end and into the microneedle array using a spring-driven piston relative to the housing. The inventive features cover both mechanical actuation and the internal fluid communication/forcing architecture.
Perpendicular microneedle array displacement by a first stored energy device
Displacing a microneedle array in a direction perpendicular to a first major surface of an applicator, where the first major surface comprises the microneedle array, and using a first stored energy device actuatable for applying force to accelerate the applicator generally normal to the first major surface.
Automatic opening of a septum-sealed drug cartridge to establish fluid communication
Opening an openable end of a drug cartridge having the openable end sealed by a septum, and automatically opening the openable end with a second stored energy device such that the openable end and a pathway are in fluid communication.
Manifold carrier pathway between cartridge openable end and microneedle array
Establishing fluid communication between the openable end and the microneedle array through a pathway communicable between the openable end and the microneedle array, where the pathway passes through a manifold carrier fixedly attached to the microneedle array.
Spring-driven piston forces fluid through openable end, pathway, and microneedle array
Using the second stored energy device including a spring member that moves the piston relative to the housing so that, when actuated, the second stored energy device forces the fluid through the openable end, the pathway, and the microneedle array.
Housing actuator coordinates first and second stored energy devices
Including a housing that supports the applicator and the drug cartridge and includes an actuator for actuating the first and second stored energy devices.
Overall, the claim coverage centers on coordinated actuation: perpendicular acceleration of an applicator with a microneedle array, automatic opening of a septum-sealed cartridge to create fluid communication via a manifold carrier pathway, and forcing cartridge fluid through the pathway and into the microneedle array using a spring-member-driven piston relative to the housing.
Stated Advantages
Documented Applications
No documented applications found
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