Method of delivering material or stimulus to a biological subject

Inventors

Kendall, Mark Anthony Fernance

Assignees

Vaxxas Pty Ltd

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Publication Number

US-9888932-B2

Patent

Publication Date

2018-02-13

Expiration Date


Abstract

A device for delivery of material or stimulus to targets within a body to produce a desired response, the targets being at least one of cells of interest, cell organelles of interest and cell nuclei of interest. The device includes a number of projections for penetrating a body surface, with the number of projections being selected to produce a desired response, and the number being at least 500. A spacing between projections is also at least partially determined based on an arrangement of the targets within the body.

Core Innovation

The invention describes a device for applying to a biological subject, the device comprising a solid base and solid, non-porous, non-hollow projections extending from the base. Each projection comprises a tip for penetrating a surface of the biological subject, and the device includes a high number of projections with quantitative projection geometry constraints including length, base width, spacing, tip diameter, and projection density, together with the requirement that at least a portion of at least one projection is coated with a non-liquid coating.

The invention further provides that the non-liquid coating is used on the penetrating projections to deliver a material or stimulus. In particular, the invention includes methods for delivering vaccine to produce an immunological response, with projections being at least partially coated with a non-liquid vaccine, and methods where coated projections are used to induce bystander responses by perturbing cells within the biological subject.

The invention is additionally framed as treating a biological subject using a skin penetrating device or a device for delivery of material. The treated subject is engaged by applying the device so that the projections penetrate the surface, while the device remains defined by the same structural constraints on projection count, length range, base width range, spacing range, tip diameter limit, and projection density, together with non-liquid coating on at least a portion of at least one projection.

Claims Coverage

The document provides multiple independent method claims, each defining a delivery device with solid base and solid, non-porous projections extending from the base, and each requiring non-liquid coating on at least a portion of at least one projection. Across the independent claims, the inventive features focus on projection array structure and coating, with additional claim-specific outcomes including vaccine immunological response, cell perturbation leading to bystander responses, and insertion-force application or skin-penetrating treatment framing.

Non-liquid coated solid non-porous non-hollow penetrating projection array device

Applying a device comprising a solid base and solid, non-porous, non-hollow projections extending from the base, each projection having a tip for penetrating a surface, wherein the number of projections is at least 500; each projection has a length of between 200 μm and 1000 μm; each projection has a base width of between 5 μm and 50 μm; the projections are separated by a spacing of between 10 μm and 200 μm; the tip is less than 500 nm in diameter; the density of the projections is between 10 projections/mm^2 to 100 projections/mm^2; and wherein at least a portion of at least one projection is coated with a non-liquid coating.

Insertion force application of non-liquid coated solid non-porous projection array

Applying a device comprising a base and non-porous projections extending from the base, each projection having a tip for penetrating a surface, wherein the number of projections is at least 500; each projection has a length of between 200 μm and 1000 μm; each projection has a base width of between 5 μm and 50 μm; the projections are separated by a spacing of between 10 μm and 200 μm; the tip is less than 500 nm in diameter; the density of the projections is between 10 projections/mm^2 to 100 projections/mm^2; and wherein at least a portion of at least one projection is coated with a non-liquid coating, wherein the method comprises applying the device by inserting at least the tips of the projections into the surface with an insertion force.

Non-liquid vaccine coated penetrating projection device for immunological response

Applying a device comprising a solid base and solid, non-porous projections extending from the base, each projection having a tip for penetrating a surface, wherein the number of projections is at least 500; each projection has a length of between 200 μm and 1000 μm; each projection has a base width of between 5 μm and 50 μm; projections are separated by a spacing of between 10 μm and 200 μm; the tip is less than 500 nm in diameter; the density of the projections is between 10 projections/mm^2 to 100 projections/mm^2; and wherein one or more of the projections are at least partially coated with a non-liquid vaccine, to produce an immunological response.

Non-liquid coated solid non-porous penetrating projection device

Applying a device comprising a solid base and solid, non-porous projections extending from the base, each projection having a tip for penetrating a surface, wherein at least part of at least some of the projections is coated, and wherein the number of projections is at least 500; each projection has a length of between 200 μm and 1000 μm; each projection has a base width of between 5 μm and 50 μm; projections are separated by a spacing of between 10 μm and 200 μm; the tip is less than 500 nm in diameter; and the density of the projections is between 10 projections/mm^2 to 100 projections/mm^2; and wherein at least a portion of at least one projection is coated with a non-liquid coating.

Non-liquid coated penetrating projection device for delivering stimulus

Applying a device comprising a solid base and solid, non-porous projections extending from the base, each projection having a tip for penetrating a surface, wherein the number of projections is at least 500; each projection has a length of between 200 μm and 1000 μm; each projection has a base width of between 5 μm and 50 μm; projections are separated by a spacing of between 10 μm and 200 μm; the tip is less than 500 nm in diameter; and the density of the projections is between 10 projections/mm^2 to 100 projections/mm^2; wherein at least a portion of at least one projection is coated with a non-liquid coating.

Skin penetrating non-porous coated projection array device for treating a biological subject

Applying a skin penetrating device comprising a solid base and a number of solid, non-porous projections extending from the base arranged in an array, each projection having a tip for penetrating a surface of the biological subject, wherein the number of projections is at least 500; each projection has a length of between 200 μm and 1000 μm; each projection has a base width of between 5 μm and 50 μm; projections are separated by a spacing of between 10 μm and 200 μm; the tip is less than 500 nm in diameter; and the density of the projections is between 10 projections/mm^2 to 100 projections/mm^2; and wherein at least a portion of at least one projection is coated with a non-liquid coating.

Non-liquid coated solid non-porous penetration array device for treating a biological subject

Using a device for delivery of material to a biological subject comprising a solid base and solid, non-porous projections extending from the base, each projection having a tip for penetrating a surface, wherein the number of projections is at least 500; each projection has a length of between 200 μm and 1000 μm; each projection has a base width of between 5 μm and 50 μm; projections are separated by a spacing of between 10 μm and 200 μm; the tip is less than 500 nm in diameter; and the density of the projections is between 10 projections/mm^2 to 100 projections/mm^2; wherein at least a portion of at least one projection is coated with a non-liquid coating.

Across the independent claims, the coverage centers on applying a dense array of solid, non-porous (and in one claim non-hollow) penetrating projections with specified geometric and density ranges, combined with non-liquid coating on at least a portion of at least one projection. Claim-specific differences include insertion-force application and specific therapeutic contexts, including delivery of vaccine to produce an immunological response and delivery of stimulus capable of cell perturbation and bystander responses, as well as skin-penetrating treatment framing.

Stated Advantages

Not explicitly described in patent.

Documented Applications

Not explicitly described in patent.

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