Apparatus and method for the collection of interstitial fluids

• US 6,786,874 B2
• Filed: 09/13/2002
• Issued: 09/07/2004
• Est. Priority Date: 01/26/2001
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Lowery, Michael G., Kotlarik, John J., Schmidt, Daniel P., Schapira, Thomas G., Bojan, Pete M., Cunningham, David Dean, Huang, Tung-Ming, Hiltibran, Robert G., Wong, Sie Ting, Noonan, Kristin M., Grace, John P., Tarkowski, Brian Joseph, Loomis, Neil W., Pope, Mark R.
• Primary Examiner(s): Jones, Mary Beth
• Assistant Examiner(s): Szmal, Brian
• Application Number:
  US10/243,584
• Publication Number:
  US 20030114774A1
• Time in Patent Office: 725 Days
• Field of Search: 600/573, 600/583, 600/578, 600/574-577, 600/579-582, 604/317, 606/180, 606/181, 606/182
• US Class Current: 600/573
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2017/00765 Decreasing the barrier function of skin tissue by radiated energy, e.g. using ultrasound, using laser for skin perforation

Abstract

The present invention involves apparatus and methods for use in collecting bodily fluids, such as interstitial fluids, from the epidermal layer of an animal. A preferred apparatus includes a pressure head and, optionally, a holder therefor for supplying a positive pressure to the head. The methods include the application of a positive pressure to the area surrounding an epidermal site from which stratum corneum has been breached, such as by laser ablation, to cause bodily fluids, such as interstitial fluids, to exude from the site and collecting the fluids exuding therefrom.

Claims

1. An apparatus for the collection of interstitial fluids from the body of an animal, comprising:

a pressure head having a top portion and a bottom portion, with an exterior wall and an interior wall extending therebetween, said top portion having the major dimension thereof at least as great as the major dimension of said bottom portion;

an aperture extending through said bottom portion and in fluid communication with a reservoir;

said aperture having an area less than the area of said bottom portion, said aperture having a major dimension of from about 2.5 mm to about 3.0 mm.

2. The apparatus of claim 1, further including a holder for mating engagement with said pressure head, said holder including a drive connectable with said pressure head, said drive adapted to supply a force to said pressure head in a direction from said top portion toward said bottom portion.

3. The apparatus of claim 1, wherein the top portion of said pressure head comprises a threaded end.

4. A method for the collection of interstitial fluids from the body of an animal, comprising the steps of:

forming a breach through the stratum corneum of the animal, said breach extending at least into the epidermal layer of the skin of the animal;

placing the pressure head of claim 1 adjacent to said breach;

exerting a positive pressure on said head in a direction generally toward the skin of the animal; and

collecting fluids from said breach.

5. The method of claim 4, wherein the step of forming a breach comprises forming at least one micropore through said stratum corneum.

6. The method of claim 4, wherein the pressure head applies a force ranging from about 1 to about 11 pounds.

7. A method for the collection of interstitial fluids from the body of an animal, comprising the steps of:

placing the pressure head of claim 1 against the skin of the animal;

forming a breach through the stratum corneum of the animal, said breach extending at least into the epidermal layer of the skin of the animal, said breach adjacent to said pressure head;

exerting a positive pressure on said head in a direction generally toward the skin of the animal; and

collecting fluids from said breach.

8. The method of claim 7, wherein the step of forming a breach comprises forming at least one micropore through said stratum corneum.

9. The method of claim 7, wherein the pressure head applies a force ranging from about 1 to about 11 pounds.

10. The method of claim 7, wherein said pressure head applies a force prior to the formation of said breach.

11. A method for the collection of interstitial fluids from the body of an animal, comprising the steps of:

forming a breach through the stratum corneum of the animal, said breach extending at least into the epidermal layer of the skin of the animal;

exerting a positive pressure adjacent to said breach in a direction generally toward the skin of the animal, said positive pressure being exerted by means of the pressure head of claim 1; and

collecting fluids from said breach.

12. The method of claim 11, wherein the step of forming a breach comprises forming at least one micropore through said stratum corneum.

13. The method of claim 12, wherein the positive pressure exerted involves a force ranging from about 1 to about 11 pounds.