Intracutaneous microneedle array apparatus

• US 6,931,277 B1
• Filed: 05/26/2000
• Issued: 08/16/2005
• Est. Priority Date: 06/09/1999
• Status: Expired due to Term

• Current Assignee: Corium, Inc.
• Original Assignee: The Procter & Gamble Company
• Inventors: Sherman, Faiz Feisal, Garstein, Vladimir, Owens, Grover David, Yuzhakov, Vadim Vladimirovich
• Primary Examiner(s): Lucchesi, Nicholas D.
• Assistant Examiner(s): DESANTO, MATTHEW F
• Application Number:
  US09/580,819
• Time in Patent Office: 1,908 Days
• Field of Search: 604272-274, 604/22, 604/20, 604/264, 604/21
• US Class Current: 604/21
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/1723 using feedback of body parameters, e.g. blood-sugar, pressure measurement of body parameters A61B5/00
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: B81B 2201/055 Microneedles
• CPC Class Codes: B81C 99/0085 using moulds and master templates, e.g. for hot-embossing

Abstract

Improved microneedle arrays are provided having a sufficiently large separation distance between each of the individual microneedles to ensure penetration of the skin while having a sufficiently small separation distance to provide high transdermal transport rates. A very useful range of separation distances between microneedles is in the range of 100–300 microns, and more preferably in the range of 100–200 microns. The outer diameter and microneedle length is also very important, and in combination with the separation distance will be crucial as to whether or not the microneedles will actually penetrate the stratum corneum of skin. For circular microneedles, a useful outer diameter range is from 20–100 microns, and more preferably in the range of 20–50 microns. For circular microneedles that do not have sharp edges, a useful length for use with interstitial fluids is in the range of 50–200 microns, and more preferably in the range of 100–150 microns; for use with other biological fluids, a useful length is in the range of 200 microns–3 mm, and more preferably in the range of 200–400 microns. For circular microneedles having sharp side edges, a useful length for use with interstitial fluids is in the range of 50–200 microns, and more preferably in the range of 80–150 microns; for use with other biological fluids, a useful length is again in the range of 200 microns–3 mm, and more preferably in the range of 200–400 microns. For solid microneedles having a star-shaped profile with sharp edges for its star-shaped blades, a useful length for use with interstitial fluids is in the range of 50–200 microns, and more preferably in the range of 80–150 microns; for use with other biological fluids, a useful length is again in the range of 200 microns–3 mm, and more preferably in the range of 200–400 microns, while the radius of each of its blades is in the range of 10–50 microns, and more preferably in the range of 10–15 microns.

Claims

1. An integral structure comprising a base element and plurality of microneedles formed thereon, said microneedles suitable for penetrating the stratum corneum layer of skin, wherein said base element has a first side and a second side;

said plurality of microneedles comprising a plurality of projections disposed on said outer surface of said microneedles and which extend from the second side of said base element along longitudinal axes, in a longitudinal direction from a proximal end towards a distal end, and exhibiting at least one angle with respect to said base element; and

said plurality of projections being spaced apart from one another at a substantially predetermined separation distance, and said plurality of projections having a substantially uniform length, wherein;

said substantially predetermined separation distance is within a range of 50–

1000 microns, and said substantially uniform length is within a range of 50–

3000 microns,

wherein said microneedles have at least one elongate sharp edge that enhances penetration of said microneedles through the stratum corneum layer of skin, wherein said elongate sharp edge is oriented in the longitudinal direction and extends entirely from said proximal end of said microneedle to said distal end of said microneedle.