Apparatus and method for the collection of interstitial fluids

• US 20030114774A1
• Filed: 09/13/2002
• Published: 06/19/2003
• Est. Priority Date: 01/26/2001
• Status: Active Grant

• Current Assignee: Brian Joseph Tarkowski, Daniel P. Schmidt, David Dean Cunningham, John J. Kotlarik, John P. Grace, Jon G. Hiltibran, Kristin M. Noonan, Mark R. Pope, Michael G. Lowery, Neil W. Loomis, Pete M. Bojan, Robert G. Hiltibran, Sie Ting Wong, Thomas G. Schapira, Tung-Ming Huang
• Original Assignee: Brian Joseph Tarkowski, Daniel P. Schmidt, David Dean Cunningham, John J. Kotlarik, John P. Grace, Jon G. Hiltibran, Kristin M. Noonan, Mark R. Pope, Michael G. Lowery, Neil W. Loomis, Pete M. Bojan, Robert G. Hiltibran, Sie Ting Wong, Thomas G. Schapira, Tung-Ming Huang
• Inventors: Schmidt, Daniel P., Loomis, Neil W., Pope, Mark R., Bojan, Pete M., Cunningham, David Dean, Huang, Tung-Ming, Hiltibran, Robert G., Wong, Sie Ting, Noonan, Kristin M., Grace, John P., Tarkowski, Brian Joseph, Hiltibran, Jon G., Lowery, Michael G., Kotlarik, John J., Schapira, Thomas G.
• Granted Patent: US 6,786,874 B2
• Time in Patent Office: Days
• 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. 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 a pressure head 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.

2. The method of claim 1, wherein the step of forming a breach comprises forming at least one micropore through said stratum corneum.

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

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

placing a pressure head 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.

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. The method of claim 4, wherein said pressure head applies a force prior to the formation of said breach.

20. The method of claim 4, wherein said pressure head applies a force prior to the formation of said breach.

8. 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;

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.

9. The apparatus of claim 8, 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.

10. 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; and

collecting fluids from said breach.

11. The method of claim 10, wherein the step of forming a breach comprises forming at least one micropore through said stratum corneum.

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

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

a cylinder;

a piston capable of traveling upwardly and downwardly in said cylinder, said piston having an upper surface and a pressure head, said pressure head having an aperture extending therethrough and in fluid communication with a reservoir, said aperture having an area less than the area of said pressure head;

a means for evacuating air from said cylinder, so that said piston can be forced to move downwardly by means of atmospheric pressure acting on said upper surface of said piston, whereby said piston is capable of exerting a positive pressure on a surface.

14. 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 apparatus of claim 13 adjacent to said breach in said stratum corneum in such a manner that said aperture of said pressure head of said apparatus is in register with said breach;

evacuating air from said cylinder of said apparatus of claim 13, whereby atmospheric pressure exerts a positive pressure adjacent to said breach in a direction generally toward the skin of the animal; and

collecting fluids from said breach.

15. The method of claim 14, wherein the step of forming a breach comprises forming at least one micropore through said stratum corneum.

16. The method of claim 14, wherein the positive pressure exerted involves a force ranging from about 1 to about 11 pounds.

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

placing the apparatus of claim 13 against the skin of said 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 being in register with said aperture of said pressure head of said apparatus;

evacuating air from said cylinder of said apparatus of claim 13, whereby atmospheric pressure exerts a positive pressure adjacent to said breach in a direction generally toward the skin of the animal; and

collecting fluids from said breach.

18. The method of claim 14, wherein the step of forming a breach comprises forming at least one micropore through said stratum corneum.

19. The method of claim 14, wherein the positive pressure exerted involves a force ranging from about 1 to about 11 pounds.

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

(a) a band that can be placed around a body part;

(b) a pressure head;

(c) a means for securing the pressure head to said band.

22. The apparatus of claim 21, further comprising means for increasing the tightness of said band when said band is placed around said body part.

23. The apparatus of claim 22, wherein said means comprises a bladder located on said band.

24. 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 a body part of the animal, said breach extending at least into the epidermal layer of the skin of the animal;

placing the apparatus of claim 21 around the body part of the animal so that said pressure head is adjacent to said breach;

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

collecting fluids from said breach.

25. The method of claim 24, wherein the step of forming a breach comprises forming at least one micropore through said stratum corneum.

26. The method of claim 24, wherein the pressure head applies a force ranging from about 1 to about 11 pounds.

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

placing the apparatus of claim 21 around the body part of an 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;

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

collecting fluids from said breach.

28. The method of claim 27, wherein the step of forming a breach comprises forming at least one micropore through said stratum corneum.

29. The method of claim 27, wherein the positive pressure exerted involves a force ranging from about 1 to about 11 pounds.

30. The method of claim 27, wherein said pressure head applies a force prior to the formation of said breach.