Method for transdermal nucleic acid sampling

• US 6,749,575 B2
• Filed: 08/20/2001
• Issued: 06/15/2004
• Est. Priority Date: 08/20/2001
• Status: Expired due to Term

• Current Assignee: ALZA Corporation (Johnson & Johnson)
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Cormier, Michel J. N., Matriano, James A.
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): FOREMAN, JONATHAN M
• Application Number:
  US09/933,647
• Publication Number:
  US 20030036710A1
• Time in Patent Office: 1,030 Days
• Field of Search: 600/562, 600/564, 600/565, 600/569, 600/570, 600/571, 600/572, 600/573, 600/583, 600/575, 600/576
• US Class Current: 600/564
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61B 2010/008 Interstitial fluid

Abstract

A minimally invasive transdermal nucleic acid sampling method comprises piercing through the outermost layer of the skin and into the underlying epidermis with a plurality of microprojections. Living skin cells in the underlying epidermis are disrupted, causing them to release their contents including their nucleic acids (i.e., DNA, RNA, fragments thereof or other polynucleic acid material found in the nucleii and/or mitochondria of cells). The nucleic acid is collected on the surfaces of the microprojections and/or in a separate nucleic acid collection reservoir. The collected nucleic acid is then analyzed using standard polymerase chain reaction (PCR) techniques. Optionally a suction device applies a partial vacuum through openings in the microprojection member to the microcuts in the skin for enhanced efflux of intracellular and extracellular (i.e., body) fluids containing the nucleic acid.

Claims

1. A method of transdermally sampling nucleic acid comprising:

piercing through the stratum corneum layer of skin into at least an underlying epidermis layer with a skin-piercing microprojection, disrupting or dislodging skin cells containing nucleic acid;

collecting the nucleic acid from the disrupted or dislodged skin cells by allowing the microprojection to become at least partially coated with nucleic acid-containing body fluid, withdrawing from the skin the microprojection and the nucleic acid-containing body fluid coated thereon;

removing at least some of the nucleic acid from the microprojection and analyzing the nucleic acid removed from the withdrawn microprojection.

7. The method of any of claims 1 or 2-6, wherein the step of analyzing the nucleic acid comprises the polymerase chain reaction assay.

8. The method of any of claims 1 to 2 or 5-9, wherein the skin is the skin of a human.

9. The method of any of claims 1 or 2-6, wherein the nucleic acid is selected from the group consisting of DNA, DNA fragments, RNA, RNA fragments, genes, chromosomes, and polynucleic acid sequences.

2. A method of transdermally sampling nucleic acid comprising:

piercing through the stratum corneum layer of skin into at least an underlying epidermis layer to a depth of less than about 500 μ

m with a skin-piercing microprojection, disrupting or dislodging skin cells containing nucleic acid, collecting the nucleic acid from the disrupted or dislodged skin cells by allowing the microprojection to become at least partially coated with nucleic acid-containing body fluid, withdrawing from the skin the microprojection and the nucleic acid-containing body fluid coated thereon;

removing at least some of the nucleic acid from the microprojection; and

analyzing the nucleic acid removed from the withdrawn microprojection.

3. A method of transdermally sampling nucleic acid comprising:

piercing through the stratum corneum layer of skin into at least an underlying epidermis layer with a plurality of skin-piercing microprojections and disrupting or dislodging skin cells containing nucleic acid;

collecting the nucleic acid from the disrupted or dislodged skin cells by allowing at least one of the microprojections to become at least partially coated with nucleic acid-containing body fluid;

withdrawing from the skin the microprojections and the nucleic acid-containing body fluid coated thereon;

removing at least some of the nucleic acid from the microprojection; and

analyzing the nucleic acid removed from the withdrawn microprojections.

4. A method of transdermally sampling nucleic acid comprising:

piercing through the stratum corneum layer of skin into at least an underlying epidermis layer with a multiplicity of skin-piercing microprojections and disrupting or dislodging skin cells containing nucleic acid;

collecting the nucleic acid from the disrupted or dislodged skin cells by allowing at least one of the microprojections to become at least partially coated with nucleic acid-containing body fluid;

withdrawing from the skin the microprojections and the nucleic acid-containing body fluid coated thereon;

removing at least some of the nucleic acid from the microprojections; and

analyzing the nucleic acid removed from the withdrawn microprojections.

5. A method of transdermally sampling nucleic acid comprising:

piercing through the stratum corneum layer of skin to a depth of at least about 25 μ

m and into at least an underlying epidermis layer with a skin-piercing microprojection, disrupting or dislodging skin cells containing nucleic acid;

collecting the nucleic acid from the disrupted or dislodged skin cells by allowing the microprojection to become at least partially coated with nucleic acid-containing body fluid;

withdrawing from the skin the microprojection and the nucleic acid-containing body fluid coated thereon;

removing the nucleic acid from the microprojection; and

analyzing the nucleic acid removed from the withdrawn microprojection.

6. A method of transdermally sampling nucleic acid comprising:

piercing through the stratum corneum layer of skin into at least an underlying epidermis layer with an array of skin-piercing microprojections, the array having a microprojection density of at least about 10 microprojections/cm², disrupting or dislodging skin cells containing nucleic acid;

collecting the nucleic acid from the disrupted or dislodged skin cells by allowing the array of microprojections to become at least partially coated with nucleic acid-containing body fluid;

withdrawing from the skin the array of microprojections and the nucleic acid-containing body fluid coated thereon;

removing the nucleic acid from the microprojections; and

analyzing the nucleic acid removed from the withdrawn microprojection array.