MICROPROTRUSION ARRAYS AND METHODS FOR USING SAME TO DELIVER SUBSTANCES INTO TISSUE

• US 20090270792A1
• Filed: 06/18/2009
• Published: 10/29/2009
• Est. Priority Date: 08/29/2002
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Martin, Frank E., Haider, M. Ishaq, Alarcon, Jason B., Mikszta, John A., Lastovich, Alexander G., Dekker, John P. III, O'Connor, Scott A.
• Granted Patent: US 8,075,826 B2
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61M 2037/0007 having means for enhancing the permeation of substances through the epidermis, e.g. using suction or depression, electric or magnetic fields, sound waves or chemical agents
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

Improved microprotrusion abrasion devices having fluid retaining or directing patterns, and specific design parameters and method for delivery of substances into the skin. Various configurations of such devices are disclosed, including domed, channeled, patterned and stepped.

Claims

1. A method for forming a lenticular micro protrusion array comprising:

providing a substantially planar microprotrusion array comprising a plurality of microprotrusions each protrusion comprising a frustoconical protrusion with at least one scraping edge attached to a planar substrate;

providing a fixture having a top block and a bottom block wherein the fixture is adapted to hold the planar microprotrusion array, and the top block further comprises a lenticular forming mandrel adapted to deform the planar microprotrusion array;

removably affixing the planar microprotrusion array into the bottom block with the plurality of microprotrusions facing away from the top block;

heating the microprotrusion array to a temperature such that microprotrusion array may be plastically deformed;

lowering the forming mandrel onto the microprotrusion array;

cooling the microprotrusion array to such a temperature that the geometry of the forming mandrel is substantially maintained.

2. The method of claim 1 further comprising deforming the planar array approximately 0.040″

to 0.10 inches in total height from the center of microprotrusion array to an edge of microprotrusion array.

3. The method of claim 1, wherein the plurality of microprotrusions are substantially unchanged in shape

4. The method of claim 1, wherein the lenticular micro protrusion has a pattern of attached microprotrusions adapted to direct said substance comprises areas of differing microprotrusion densities.

5. The method of claim 1 wherein said microprotrusion array is comprised of a thermoplastic material.

6. The method of claim 1 wherein the lenticular microprotrusion array is a substantially a converging meniscus.

7. The method of claim 1 wherein the lenticular microprotrusion array is a substantially a diverging meniscus.

8. The method of claim 1 wherein the lenticular microprotrusion array is a substantially a cylindrical bend.