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Publication Number
US-11828584-B2
Publication Date
2023-11-28
Expiration Date
Abstract
The present invention relates to devices and methods for detecting the amount (degree, extent) of material coating a medical device or substrate, in particular the present invention relates to devices and methods for detecting the amount of vaccine material coating a microarray patch.
Core Innovation
The invention relates to quality-control for microarray patch microprojections by non-destructively measuring a coating on the microprojections on a microprojection array. It uses electromagnetic radiation, including laser-based reflectance and/or fluorescence, to determine coating amount and spatial distribution. The approach compares signals from coated microprojections to signals associated with reference or uncoated regions to infer coating and transfer efficiency and to reject out-of-specification patches.
A device implementation is described in which a laser diode emits electromagnetic radiation that is shaped and focused onto a microprojection array through an aspheric lens, a beam shaping diffuser, and a focusing lens. Reflected electromagnetic radiation from the microprojection array is collected by a receiver housing including a bi-convex lens and one or more sensors. The optical path and sensor arrangement are configured to preferentially sample different microprojection regions, such as a tip region versus a base region, to support spatially resolved measurements.
The document further describes measurement and analysis concepts that correlate normalized reflectance with transfer efficiency and enable acceptance thresholding, including the use of spatially resolved point scanning. By measuring reflectance at different positions across the microprojection array, the approach generates a heat map representing coating variability. Additional spectroscopic considerations, including fluorescence and FTIR spectral imaging, are discussed as part of determining coating properties such as coating degree, extent, and distribution.
Claims Coverage
The partial content provides one independent claim directed to a device for measuring coating on microprojections on a microprojection array using laser-diode illumination and a receiver that detects reflected electromagnetic radiation with one or more sensors. The described dependent claims add further inventive limitations related to wavelength/detector specification and sensor geometry/orientation.
Laser-diode illumination path for coating measurement on microprojections
A microprojection array housing mounts a microprojection array having a plurality of coated microprojections, and a laser diode housing emits electromagnetic radiation shaped by an aspheric lens, a beam shaping diffuser, and a focusing lens to focus the shaped electromagnetic radiation onto the microprojection array.
Receiver optics and sensor detection of reflected electromagnetic radiation
A receiver housing includes a bi-convex lens that receives reflected electromagnetic radiation from the microprojection array and focuses it onto one or more sensors for detecting the reflected electromagnetic radiation from the microprojection array.
Illumination wavelength range for the laser diode
The device comprises a laser diode configured to emit electromagnetic radiation in a wavelength range of approximately 200 nm to 10000 nm.
Silicon photodiode sensor implementation and detection range
The one or more sensors comprise a silicon photodiode with a detection range of 200 to 1100 nm.
Sensor positioning relative to microprojection rows
The sensors are positioned at approximately a 45-degree downward angle relative to the microprojections and are oriented approximately 45 degrees out of alignment with the rows of microprojections.
Substantially perpendicular illumination orientation
The device is configured so that the laser diode is substantially perpendicular to the microprojection array.
Across the independent and described dependent features, the claim coverage focuses on a device that illuminates coated microprojections using a laser-diode illumination path with specified optical shaping and focusing, then measures coating-related signals by collecting reflected electromagnetic radiation with receiver optics and detecting it with one or more sensors, further refining wavelength/detector characteristics and sensor placement/orientation.
Stated Advantages
Non-destructively determining coating amount and spatial distribution on microprojections on a microprojection array.
Inferring coating/transfer efficiency by comparing signals from coated microprojections and reference or uncoated regions.
Rejecting out-of-specification microarray patch samples based on measured coating-related signals.
Providing spatially resolved quality control through point scanning to generate a heat map of coating variability.
Documented Applications
Quality-control of microarray patches (microarray patch microprojections), including vaccine-related biologic coating and transfer efficiency evaluation.
Spectroscopic and imaging-based coating characterization for coating degree, extent, and distribution, including use of point scanning to produce spatial heat maps.
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