METHOD OF DELIVERING MATERIAL OR STIMULUS TO A BIOLOGICAL SUBJECT

• US 20120083762A1
• Filed: 10/03/2011
• Published: 04/05/2012
• Est. Priority Date: 01/30/2004
• Status: Active Grant

• Current Assignee: Vaxxas Pty Ltd.
• Original Assignee: Vaxxas Pty Ltd.
• Inventors: Kendall, Mark Anthony Fernance
• Granted Patent: US 9,888,932 B2
• Time in Patent Office: Days
• US Class Current: 604/506
• 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

1-45. -45. (canceled)

46. A method of delivering material or stimulus to a biological subject, the method comprising applying a device to the biological subject, the device comprising:

a) a base; and

b) projections extending from the base, 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; and

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

m and 200 μ

m.

47. A method according to claim 46, wherein the device is used to deliver material or stimulus to one or more cells within the biological subject.

48. A method according to claim 47, wherein the device is used to deliver material or stimulus to one or more dermal cells.

49. A method according to claim 46, wherein the tips of the projections penetrate the surface of the biological subject to thereby deliver material or stimulus to the biological subject.

50. A method according to claim 49, wherein at least the tips of one or more of the projections penetrate the dermis of the biological subject to thereby deliver material or stimulus to dermal cells within the biological subject.

51. A method according to claim 46, wherein the method comprises providing a coating on at least part of one or more of the projections, and wherein the device is used to deliver at least some of the coating to the biological subject.

52. A method according to claim 51, wherein the coating is a bioactive material for delivery to the biological subject.

53. A method according to claim 51, wherein the coating is a non-liquid coating including a material for delivery to the biological subject.

54. A method according to claim 51, 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, viruses, or virus-like particles;

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

f) metals or metallic compounds;

g) molecules, elements or compounds; and

h) mixtures thereof.

55. A method according to claim 51, wherein the coating comprises a vaccine for delivery to the biological subject to thereby produce an immunological response within the biological subject.

56. A method according to claim 51, wherein the coating comprises one or more antigens for delivery to the biological subject to thereby produce a tolerogenic response within the biological subject.

57. A method according to claim 46, wherein one or more of the projections perturb cells within the biological subject to thereby induce bystander responses.

58. A method according to claim 46, wherein the device includes one or more uncoated projections which stimulate or perturb cells within the biological subject upon penetrating the surface of the biological subject.

59. A method according to claim 46, wherein at least part of one or more of the projections at least partially dissolves upon penetrating the surface of the biological subject.

60. A method according to claim 59, wherein a bioactive material is incorporated into the projections, and wherein the bioactive material is delivered to cells within the biological subject as the at least part of one of more of the projections dissolve.

61. A method according to claim 46, wherein the method comprises applying the device to the biological subject by inserting at least the tips of the projections into the surface with an insertion force.

62. A method according to claim 61, wherein the device is applied using an applicator having an actuator for providing the insertion force.

63. A method according to claim 61, wherein the insertion force is determined at least in part based on mechanical properties of tissues of the biological subject to be penetrated.

64. A method according to claim 61, wherein the insertion force is less than 1 N.

65. A method according to claim 46, wherein the method comprises:

a) inserting the projections through the surface of the biological subject and into tissues of interest within the biological subject;

b) holding the device in place for a sufficient time to produce a desired response within the biological subject; and

c) retracting the device from the biological subject.

66. A method according to claim 65, wherein the tissues of interest comprise the dermis of the biological subject.

67. A method according to claim 65, wherein the projections are coated with a vaccine, and wherein the desired response is an immunological response.

68. A method of delivering vaccine to a biological subject to produce an immunological response, the method comprising applying a device to the biological subject, the device comprising:

a) a base; and

b) projections extending from the base, 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) projections are separated by a spacing of between 10 μ

m and 200 μ

m; and

v) one or more of the projections are at least partially coated with a vaccine.

69. A method according to claim 68, wherein the tips of the projections penetrate the surface of the biological subject to thereby deliver the vaccine to the biological subject.

70. A method according to claim 68, wherein at least part of one or more of the projections partially or fully dissolve upon penetrating the surface of the biological subject, thereby delivering the vaccine to biological subject.

71. A method for delivering material to a biological subject, the method comprising applying a device to the biological subject, the device comprising:

a) a base; and

b) projections extending from the base, wherein each projection comprises a tip for penetrating a surface of the biological subject, and wherein at least part of at least some of the projections is coated, 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; and

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

m and 200 μ

m.

72. A method according to claim 71, wherein the coating is a non-liquid coating including a bioactive material.

73. A method according to claim 71, wherein the device is used to deliver material to cells within the biological subject.

74. A method for delivering stimulus to a biological subject, the method comprising applying a device to the biological subject, the device comprising:

a) a base; and

b) projections extending from the base, wherein each projection comprises a tip for penetrating a surface of the biological surface, 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; and

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

m and 200 μ

m.

75. A device according to claim 74, wherein at least some of the projections perturb cells within the biological subject to thereby induce bystander responses.

76. A method of treating a biological subject, the method comprising applying a skin penetrating device to a biological subject, the device comprising:

a) a base; and

b) a number of 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; and

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

m and 200 μ

m.

77. A method of treating a biological subject, the method comprising using a device for delivery of material or stimulus biological subject, the device comprising:

a) a base; and

b) projections extending from the base, 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; and

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

m and 200 μ

m.

78. A method of treating a subject, the method comprising using a device for delivery of material or stimulus to targets within the subject'"'"'s 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 comprising a number of projections for penetrating a body surface, and wherein:

a) the number of projections is selected to produce a desired response, the number being at least 500; and

,

b) a spacing between projections is at least partially determined based on an arrangement of the targets within the body.