Delivery device
Inventors
Kendall, Mark Anthony Fernance • Meliga, Stefano • Depelsenaire, Alexandra Christina Isabelle • Crichton, Michael Lawrence • Flaim, Christopher
Assignees
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Publication Number
US-11179553-B2
Publication Date
2021-11-23
Expiration Date
Abstract
A device for delivery of material to a biological subject, the device including a base and a number of projections extending from the base, each projection including a tip for penetrating tissue of the biological subject, at least a portion of at least one of the projections being coated with a non-liquid coating including the material. At least the tip of at least one of the coated projections may have a convex effective profile. The device may be for delivery of material to a dermal layer of the biological subject. In another aspect an applicator for applying the device to the biological subject applies a preload force to the tissue such that the force at least partially compresses a subcutaneous tissue layer of the biological subject prior to application of the device, and applies the device with a predetermined velocity, wherein tissue stiffness is maintained and/or the projections penetrate the tissue to a predetermined depth.
Core Innovation
The invention relates to a device for delivery of a biochemical compound to a biological subject, using a base and multiple solid, non-porous projections extending from the base. Each projection includes a cylindrical support section transitioning into a coated, convex end section having a tip, with the transition forming a flat stepped surface profile between the end section and the cylindrical support section. The cylindrical support section is wider at the transition than the coated end section, and a discontinuity is closer to the base than the flat stepped surface profile, so that the flat stepped surface profile and the discontinuity interact with tissue to at least partially control penetration of the projections into the tissue and provide a physical adjuvant effect when the projections penetrate the tissue.
The cone angle measured from a centerline of each projection to an edge of the coated, convex end section varies along the length of at least one projection. The cone angle increases along the length of the end section, and the cone angle is between 1° and 10° at the tip. This varying cone angle is part of how the device controls penetration and the resulting physical adjuvant effect.
The document describes tissue-level performance characterization linking projection-mediated tissue stress and cell death to enhanced immunogenicity relative to intradermal injection. It also states that antigen co-localizes with cell death, and that neutrophil infiltration in mouse skin is characterized over time after Fluvax-coated projection patches.
Claims Coverage
The independent claim coverage is provided by one independent claim. The main inventive features are the projection geometry that physically controls penetration and generates a physical adjuvant effect, combined with a cone-angle profile that increases along the end section and is between 1° and 10° at the tip.
Stepped transition projection geometry providing physical adjuvant effect
A device having solid, non-porous projections extending from a base, where each projection comprises a cylindrical support section transitioning into a coated, convex end section with a tip, the transition forming a flat stepped surface profile between the end section and the cylindrical support section, the cylindrical support section being wider at the transition than the coated end section, and a discontinuity positioned closer to the base than the flat stepped surface profile, so that the flat stepped surface profile and the discontinuity interact with tissue to at least partially control penetration and provide a physical adjuvant effect when the device is applied to penetrate tissue.
Increasing cone angle along coated convex end section tip limitation
The cone angle measured from a centerline of each projection to an edge of the coated, convex end section having a tip varies along a length of at least one projection and increases along the length of the end section, wherein the cone angle is between 1° and 10° at the tip.
Overall, the claims emphasize projection geometry features with a flat stepped transition and discontinuity for penetration control and a coated convex end section with a cone angle that increases along the end section and is constrained to 1°–10° at the tip, to provide a physical adjuvant effect when the projections penetrate tissue.
Stated Advantages
Provides a physical adjuvant effect by controlling penetration of the projections into tissue via the flat stepped surface profile and discontinuity.
Documented Applications
Delivery of a biochemical compound to a biological subject, including vaccine, allergen, antigen, and adjuvant.
Delivery of vaccine-coated projection patches to skin, with characterization of neutrophil infiltration and tissue stress/cell death after application of Fluvax-coated projection patches.
Comparison of enhanced immunogenicity after antigen co-localization with cell death versus intradermal injection.
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