DELIVERY DEVICES AND METHODS FOR SKIN AUGMENTATION

• US 20150209563A1
• Filed: 06/13/2013
• Published: 07/30/2015
• Est. Priority Date: 09/13/2012
• Status: Active Grant

• Current Assignee: Avraham Amir
• Original Assignee: Avraham Amir
• Inventors: Amir, Avraham
• Granted Patent: US 10,420,921 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2800/87 Application Devices; Containers; Packaging
• CPC Class Codes: A61K 2800/91 Injection
• CPC Class Codes: A61K 8/02 characterised by special physical form
• CPC Class Codes: A61K 8/23 Sulfur; Selenium; Tellurium; Compounds thereof
• CPC Class Codes: A61K 8/24 Phosphorous; Compounds thereof
• CPC Class Codes: A61K 8/86 Polyethers
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 2210/04 Skin
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin
• CPC Class Codes: A61Q 19/08 Anti-ageing preparations
• CPC Class Codes: B65B 3/003 Filling medical containers such as ampoules, vials, syringes or the like

Abstract

The present invention provides, inter-alia, applicators comprising an array of microneedles for administration of a composition comprising a biocompatible ceramic material effective in augmentation of skin. In particular, the applicators and methods of the present invention are aimed at filling the undesired lines, wrinkles, depressed scars and folds of a subject'"'"'s skin and restoring youthful fullness to the skin.

Claims

1-67. -67. (canceled)

68. An applicator configured for administration of a skin augmentation composition to a skin and/or sub cutis of a subject, said applicator comprising:

a substrate, wherein said substrate has a generally flattened structure having two opposing surfaces, wherein one surface is intended for being placed proximal to the skin of the subject and the other surface facing away from the skin of said subject; and

an array of microneedles, wherein the array of microneedles is located on the surface proximal to the skin of said subject, said array comprising a plurality of microneedles, wherein each of the microneedles comprises;

a skeleton made of a rigid material, the skeleton comprising;

a sharp tip section located on one end of said skeleton, the sharp tip section being configured to penetrate the skin of said subject;

a base on the opposing end of said skeleton; and

a middle section connecting between said sharp tip section and the base; and

a skin augmentation composition comprising at least one biocompatible ceramic material, wherein the augmentation composition at least partly surrounds the middle section, such that the diameter of said sharp tip section is larger than the diameter of said augmentation composition.

69. The applicator of claim 68, wherein the length of said base is equal or higher than the thickness of the epidermis at a treated area.

70. The applicator of claim 68, wherein said sharp tip section, said base and said middle section are integrally formed.

71. The applicator of claim 68, wherein said skeleton further comprises a leakage stopper;

wherein the leakage stopper is situated between said sharp tip section and said middle section; and

wherein said leakage stopper is configured to prevent leakage of said augmentation composition from the skin of said subject following extraction of said microneedle from the skin of said subject.

72. The applicator of claim 71, wherein said leakage stopper is integrally formed with said sharp tip.

73. The applicator of claim 68, wherein said base has a shape selected from the group consisting of:

a cylinder, a rectangular box, a cuboid, a triangular box and a polygonal box.

74. The applicator of claim 68, wherein said middle section is a longitudinal core extending substantially from the center of said sharp tip section to the center of said base.

75. The applicator of claim 68, wherein said biocompatible ceramic material is in the form of particles.

76. The applicator of claim 68, wherein said augmentation composition further comprises at least one type of skin augmentation material selected from the group consisting of:

a biodegradable natural substance, a biodegradable synthetic polymer, a non-biodegradable synthetic polymer, a non-biodegradable natural substance and combinations thereof.

77. The applicator of claim 68, wherein said augmentation composition comprises a biodegradable carrier.

78. The applicator of claim 68, wherein said augmentation composition further comprises a biologically active agent selected from a group consisting of:

an enzyme, a drug, a toxin and a combination thereof.

79. The applicator of claim 68, wherein said skeleton is attached to said surface of the substrate intended for being placed proximal to the skin of a subject.

80. The applicator of claim 68, wherein said skeleton is integrally formed with said surface of the substrate intended for being placed proximal to the skin of a subject.

81. The applicator of claim 68, wherein said skeleton is at least partly inserted into said substrate.

82. The applicator of claim 69, wherein at least part of the surface that is intended for being placed proximal to the skin of the subject is an adhesive surface.

83. A method for filling an undesired fold, wrinkle, line or depressed area in the skin and/or sub-cutis of a subject, comprising placing at the site of said fold, wrinkle, line or depressed area an applicator according to claim 68.

84. A microneedle for administration of a skin augmentation composition to a skin and/or sub-cutis of a subject, the microneedle comprising:

a skeleton made of a rigid material, the skeleton comprising;

a sharp tip section located on one end of said skeleton, the sharp tip section being configured to penetrate the skin of the subject;

a base on the opposing end of said skeleton; and

a middle section connecting between said sharp tip section and the base; and

a skin augmentation composition comprising at least one biocompatible ceramic material, wherein the augmentation composition at least partly surrounds the middle section, such that the diameter of said sharp tip section is larger than the diameter of said augmentation composition.

85. A method for manufacturing a microneedle for administration of a skin augmentation composition to a skin and/or sub-cutis of a subject, the method comprises:

a. producing a microneedle skeleton of a rigid material, the skeleton comprising;

a sharp tip section located on one end of said skeleton, the sharp tip section being configured to penetrate the skin of the subject;

a base on the opposing end of said skeleton; and

a middle section connecting between said sharp tip section and the base; and

b. depositing a skin augmentation composition on said skeleton such that the augmentation composition at least partly surrounds the middle section and the diameter of said sharp tip section is larger than the diameter of said augmentation composition;

wherein said augmentation composition comprises at least one biocompatible ceramic material.

86. The method of claim 85, wherein depositing the skin augmentation composition comprises preventing deposition of said skin augmentation composition around the base and sharp tip section.

87. The method of claim 85, further comprising placing said microneedle skeleton in a mold prior to depositing the skin augmentation composition, wherein the mold is configured to shape said skin augmentation composition around at least part of said middle section.

88. The method of claim 87, wherein said mold is further configured to prevent deposition of the skin augmentation composition around the base and sharp tip section.