Microprotrusion arrays and methods for using same to deliver substances into tissue

• US 7,316,671 B2
• Filed: 08/27/2003
• Issued: 01/08/2008
• 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.
• Primary Examiner(s): Lucchesi; Nicholas
• Assistant Examiner(s): Stigell; Theodore J.
• Application Number:
  US10/649,396
• Publication Number:
  US 20040077994A1
• Time in Patent Office: 1,595 Days
• Field of Search: 604 46- 47, 604/290, 604/500
• US Class Current: 604/290
• 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 delivering a therapeutic substance into skin via an abrader device comprising the steps of:

positioning at least one radial array of abrading frustoconical microprotrusions having at least one scraping edge at a delivery site on the skin of a subject, wherein said at least one radial array is attached to an abrader device comprising an abrader housing and a mechanical rotating means adapted to rotate said radial array;

mechanically rotating the array of microprotrusions against the skin of said subject with sufficient force to disrupt and substantially penetrate the stratum corneum of the subject without piercing said stratum corneum;

applying a liquid therapeutic substance to the skin of said subject at the delivery site prior to or simultaneously with said mechanical rotation of said array

retaining said therapeutic fluid substance within said radial array as the radial array is used, thereby allowing any therapeutic fluid substance which is not immediately delivered into tissue to remain in the radial array; and

removing said abrader device from the delivery site,

wherein said at least one microprotrusion array further comprises at least one platen, said platen comprising a microprotrusion surface having a plurality of microprotrusions attached thereon, and a platen edge having a thickness, wherein said at least one platen includes at least one microchannel comprising at least one portion devoid of microprotrusions radially extending from the center of the platen to the edge of the platen and having a substantially constant width.

2. The method according to claim 1, wherein said abrader housing surrounds the array of microprotrusions, and wherein the abrader housing comprises at least one housing element selected from the group consisting of an upper housing, a lower housing, an inner housing, and an outer housing, and combinations thereof and wherein at least one of said at least one housing element remains stationary during the mechanical rotation of the microprotrusion array, and when said abrader device is positioned against the skin of the subject, said at least one stationary housing component reduces the tendency of the skin at the delivery site to flex during mechanical rotation of the microprotrusion array against the skin at the delivery site.

3. The method according to claim 2, wherein the abrader housing releasably attaches to the skin of the subject at the delivery site and holds said skin taut as said microprotrusion array is mechanically rotated.

4. The method according to claim 1, further comprising the step of applying the abrader device with a predetermined amount of force to the delivery site on the skin of the subject during said mechanical rotation.

5. The method according to claim 1, wherein the microprotrusions are frustoconical protrusions with at least one scraping edge.

6. The method according to claim 1, wherein the substance is applied on the skin of the patient at the delivery site after the abrader device is positioned at the delivery site.