Delivery device

• US 9,572,969 B2
• Filed: 10/03/2011
• Issued: 02/21/2017
• Est. Priority Date: 01/30/2004
• Status: Active Grant

• Current Assignee: Vaxxas Pty Ltd.
• Original Assignee: The University of Queensland
• Inventors: Kendall, Mark Anthony Fernance
• Primary Examiner(s): LAM, ANN Y
• Application Number:
  US13/251,891
• Publication Number:
  US 20120083741A1
• Time in Patent Office: 1,968 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B33Y 80/00 Products made by additive manufacturing

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.

Claims

1. A device for delivery of material to a biological subject, the device comprising:

a) a solid base; and

b) solid, non-porous, non-hollow projections extending from the base and at least partially coated with a non-liquid coating including the material, wherein each projection comprises a tip for penetrating a surface of the biological subject, and wherein;

i) the number of projections is at least 500;

ii) each projection has a length of between 200 μ

m and 1000 μ

m;

iii) each projection has a base width of between 5 μ

m and 50 μ

m;

iv) the projections are separated by a spacing of between 10 μ

m and 200 μ

m;

v) the tip is less than 500 nm in diameter; and

vi) the density of the projections is between 10 projections/mm² to 100 projections/mm².

2. A device according to claim 1, wherein the device is used to deliver material to one or more cells within the biological subject.

3. A device according to claim 1, wherein the device is used to deliver material to one or more dermal cells.

4. A device according to claim 1, wherein each projection has a length of between 200 μ

m to 600 μ

m.

5. A device according to claim 1, wherein the projections are arranged in an array.

6. A device according to claim 1, wherein the spacing between the device has a size of less than 15×

15 mm.

7. A device according to claim 1, wherein the projections have varying dimensions.

8. A device according to claim 1, wherein at least part of the one or more of the projections are coated with a bioactive material.

9. A device according to claim 1, wherein at least part of the one or more of the projections are coated with a non-liquid coating including a bioactive material.

10. A device according to claim 1, wherein at least part of the one or more of the projections are coated with two or more different non-liquid coating materials on the same projection.

11. A device according to claim 1, wherein the coating is selected from the group consisting of:

a) nanoparticles;

b) a nucleic acid or protein;

c) an antigen, allergen, or adjuvant;

d) parasites, bacteria, fungi, viruses or virus-like particles;

e) quantum dots, SERS tags, raman tags or other nanobiosensors;

f) metabolites, amino acids, sugars, lipids, saponins or hormones;

g) complex carbohydrates, phospholipids, peptides, polypeptides or peptidominmetics;

h) a pathogenic organism;

i) a vaccine; and

j) mixtures thereof.

12. A device according to claim 1, wherein at least part of one or more of the projections are coated with a vaccine.

13. A device according to claim 12, wherein the vaccine produces an immunological response in the biological subject.

14. A device according to claim 1, wherein one or more of the projections perturb cells within the biological subject in use to thereby induce bystander responses.

15. A device according to claim 1, wherein the tissues of interest comprise the dermis of the biological subject.

16. A device according to claim 1, wherein the length of one or more of the projections is sufficient to penetrate the dermis of the biological subject.

17. A device according to claim 1, wherein the length of at least some of the projections is at least partially determined in accordance with properties of the surface of the biological subject against which the device is to be applied in use.

18. A device according to claim 1, wherein one or more of the projections have a conical shape which tapers gradually from the base to the tip along the length of the projection.

19. A device according to claim 1, wherein one or more of the projections have a shape which varies along its length.

20. A device according to claim 19, wherein one or more of the projections include:

a) a support section extending directly from the base, the support section having a substantially cylindrical shape; and

b) an end section extending from the support section, the end section having a shape which tapers towards the tip.

21. A device for delivery of a vaccine to a biological subject to produce an immune response within the biological subject comprising:

a) a solid base; and

b) a number of solid, non-porous, non-hollow projections extending from the base, wherein the projections are arranged in an array, and wherein each projection comprises a tip for penetrating a surface of the biological subject, and wherein;

i) the number of projections is at least 500;

ii) each projection has a length of between 200 μ

m and 1000 μ

m;

iii) each projection has a base width of between 5 μ

m and 50 μ

m;

iv) the projections are separated by a spacing of between 10 μ

m and 200 μ

m;

v) one or more of the projections are at least partially coated with a non-liquid vaccine;

vi) the tip is less than 500 nm in diameter; and

vii) the density of the projections is between 10 projections/mm² to 100 projections/mm².