Method and apparatus for disruption of the epidermis

• US 5,879,326 A
• Filed: 04/25/1997
• Issued: 03/09/1999
• Est. Priority Date: 05/22/1995
• Status: Expired due to Term

• Current Assignee: Massachusetts General Hospital (Mass General Brigham, Inc.), Silicon Microdevices, Inc.
• Original Assignee: Massachusetts General Hospital (Mass General Brigham, Inc.)
• Inventors: Anderson, R. Rox, Godshall, Ned Allen
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Blyveis, Deborah
• Application Number:
  US08/845,627
• Time in Patent Office: 683 Days
• Field of Search: 604/46, 604/47, 604/48, 604/49, 604/51, 604/117, 604/181, 604/289, 604/290, 604/890.1
• US Class Current: 604/506
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 2017/00761 Removing layer of skin tissue, e.g. wrinkles, scars or cancerous tissue
• 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 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

A method and apparatus for mechanically disrupting a layer of skin having a known thickness without substantially disrupting underlying dermis layers below the layer of skin in question so as to facilitate the delivery of compounds across the disrupted layer. The apparatus includes a cutter having a plurality of microprotrusions having a height chosen with respect to the layer of skin that is to be disrupted and a stop for preventing the apparatus from penetrating the skin beyond a predetermined distance. In the preferred embodiment of the present invention, the microprotrusions include blades that generate cuts in the layer of skin. The cuts are generated by moving the apparatus parallel to the surface of the skin either at the time of application, during the normal movements of the individual wearing the apparatus, or both. In the preferred embodiment of the present invention, the appropriate length of blade is determined for each individual and delivery site on that individual.

Claims

1. A method for transdermal delivery of a compound to an animal at a site on that animal'"'"'s skin, said skin comprising a stratum corneum layer, an epidermis under said stratum corneum, and a dermis layer under said epidermis, said method comprising the steps of:

determining a depth of a cut that will extend through the stratum corneum of that animal at said delivery site but not penetrate the dermis of that animal at said delivery site; and

applying an apparatus at said delivery site to generate a cut extending through said stratum corneum layer, said cut extending into said epidermis but not into said dermis layer, said apparatus comprising;

a plurality of microprotrusions for disrupting the skin at said delivery site, said mircoprotrusions having a length determined by said determined depth;

stop means for preventing said apparatus from penetrating said layer of skin beyond a predetermined distance; and

applying said compound to said delivery site.

2. The method of claim 1, wherein at least one of said microprotrusions is a blade having an elongated cross-section, said blade being positioned so as to cut said layer of skin when said apparatus is moved relative to said layer of skin, and wherein said step of applying said apparatus comprises moving said apparatus across said layer of skin so as to induce a microcut in said layer skin.

3. The method of claim 1 wherein said step of determining depth comprises the steps of:

moving an apparatus having a microprotrusion of a fixed length and a stop means for preventing said microprotrusion from penetrating the animal to a depth greater than said fixed length, said moving of said apparatus inducing a microcut in said skin; and

determining if said microcut extends into the epidermis of that animal at said delivery site.

4. The method of claim 3 wherein said step of determining if said microcut extends into the epidermis of said animal comprises applying a compound to said microcut;

and determining if said compound has entered the epidermis of said animal.

5. The method of claim 1 wherein said microprotrusions comprise molded polymer or metal microprotrusions.

6. The method of claim 1 wherein the step of applying a compound to said delivery site comprises dispensing said compound through a channel in one of said microprotrusions.

7. A method for transdermal delivery of a compound to an animal at a site on that animal'"'"'s skin, said skin comprising a stratum corneum layer, an epidermis under said stratum corneum, and a dermis layer under said epidermis, said method comprising the steps of:

determining a depth of a cut that will extend through the stratum corneum of that animal at said delivery site but not penetrate the dermis of that animal at said delivery site; and

applying an apparatus at said delivery site to generate a cut extending through said stratum corneum layer, said cut extending into said epidermis but not into said dermis layer, said apparatus comprising;

a plurality of microprotrusions for disrupting the skin at said delivery site, said mircoprotrusions having a length determined by said determined depth;

stop means for preventing said apparatus from penetrating said layer of skin beyond a predetermined distance; and

applying said compound to said delivery site,

wherein said step of determining if said microcut extends into the epidermis of said animal comprising applying a compound to said microcut; and

determining if said compound has entered the epidermis of said animal, and

wherein said compound comprises a dye.

8. The method of claim 7 wherein said dye is Coomassie Blue.