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-12491351-B2
Publication Date
2025-12-09
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 disclosure describes a method for applying a projection array to a biological subject’s skin to deliver vaccine to dermal cells and thereby produce an immunological response. The method applies a preload force to at least partially compress a subcutaneous tissue layer and then applies the projection array to the skin at at least 1 m/sec.
The projection array includes a base and solid, non-porous projections having a length of from 200 µm to 600 µm. Each projection includes an uncoated cylindrical support section transitioning into a coated, convex end section having a tip, and the coating is a non-liquid coating including the vaccine.
The transition forms a flat stepped surface profile with a step offset dimension, located at a defined distance from the tip between the end section and the cylindrical support section, and a discontinuity is positioned closer to the base than the flat stepped surface profile. The cylindrical support section is wider at the transition than the coated end section.
The flat stepped surface profile and the discontinuity interact with tissue to at least partially control penetration of the projections into the tissue, thereby providing a physical adjuvant effect. The aspect ratio of the projections is less than about 6.
Claims Coverage
The independent claim describes a vaccine-delivery method using a projection array with specific projection geometry, speed, and a non-liquid coating, where tissue interaction controls penetration to provide a physical adjuvant effect. Dependent claims further constrain projection spacing and limit the vaccine to cancer vaccines comprising polynucleotides, including RNA and papillomavirus antigens E6/E7 or combinations thereof.
Projection array delivery at at least 1 m/sec with physical adjuvant geometry
Applying a preload force to at least partially compress a subcutaneous tissue layer and then applying a projection array to skin at at least 1 m/sec, where the projection array includes a base and solid, non-porous projections of length 200 µm to 600 µm having an uncoated cylindrical support section transitioning to a coated convex end section with a non-liquid coating including the vaccine, the transition forming a flat stepped surface profile and a discontinuity positioned to interact with tissue to at least partially control penetration into tissue and thereby provide a physical adjuvant effect, with projections having aspect ratio less than about 6.
Projection spacing between 70 µm and 100 µm
The projections are spaced between 70 µm and 100 µm apart.
Cancer vaccine method
The method is further defined as a cancer vaccine method.
Cancer vaccine comprising polynucleotides
The cancer vaccine comprises one or more polynucleotides.
Polynucleotides are RNA
The polynucleotides are RNA.
Papillomavirus antigens E6 or E7 or combinations
The method uses papillomavirus antigens that are E6 or E7, or combinations thereof.
The inventive coverage centers on delivering vaccine to dermal cells using solid, non-porous projections applied at at least 1 m/sec with geometry that includes a flat stepped surface profile and discontinuity to control tissue penetration and provide a physical adjuvant effect. The dependent claims further specify projection spacing between 70 µm and 100 µm and limit the vaccine to cancer vaccines comprising polynucleotides, including RNA and papillomavirus antigens E6/E7 or combinations.
Stated Advantages
Provides a physical adjuvant effect by controlling penetration through tissue interaction via the flat stepped surface profile and discontinuity.
Produces an immunological response within the biological subject.
Documented Applications
Delivering vaccine to dermal cells within a biological subject to produce an immunological response.
Cancer vaccine use, including cancer vaccines comprising polynucleotides.
Use of papillomavirus antigens that are E6 or E7, or combinations thereof.
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