Device for sample of substances using alternating polarity

• US 6,687,522 B2
• Filed: 06/28/2001
• Issued: 02/03/2004
• Est. Priority Date: 06/24/1994
• Status: Expired due to Fees

• Current Assignee: Animas Technologies LLC (Johnson & Johnson)
• Original Assignee: Cygnus, Inc. (Johnson & Johnson)
• Inventors: Tamada, Janet
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/893,916
• Publication Number:
  US 20020002328A1
• Time in Patent Office: 950 Days
• Field of Search: 600/309, 600/345, 600/347, 600/348, 600/354, 600/355, 600/357, 600/372, 600/382, 600/384, 600/356, 600/397, 604/20, 204/153.12
• US Class Current: 600/347
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/6833 Adhesive patches

Abstract

A method for sampling of a substance from a subject is provided, which comprises placing one or more sampling chambers on a collection site on a tissue surface on the subject; conducting electric current through the tissue to extract a substance from the subject in a first direction in one or more sampling chambers that functions alternatively as both an anode and cathode during the course of the method; reversing the polarity to cause direct current to flow in second direction opposite the first direction; and analyzing the sampling chamber or chambers for the concentration of a substance or a substance metabolite. There is also provided a device for sampling of a substance from an organism on continuously or intermittently using alternating polarity method based on the application of low intensity electric fields of alternating polarity across the skin (iontophoresis) to enhance the transport of a substance (such as glucose, lactic acid, pyruvic acid, and the like) from body tissues to a sampling chamber. The device comprises an electrical power supply; a transdermal system that contains one or more sampling chambers that function as both anode and cathode during the course of sampling; a means to alternates or reverses the polarity during the iontophoretic sampling; and means for analyzing for the concentration of a substance or a substance metabolite.

Claims

1. A substance monitoring device comprising

a transdermal sampling system comprising (i) a first sampling chamber for receiving a sample comprising said substance or substance metabolite, wherein the first sampling chamber comprises a first electrode that is connectable with an electrical power supply, and (ii) a second electrode that is connectable with said power supply;

means for reversing polarity between the first electrode and the second electrode, wherein the first electrode functions as both an anode and a cathode during iontophoretic sampling;

means for analyzing a concentration or amount of the substance or substance metabolite received in the first sampling chamber, and

a programed processor for correlating said concentration or amount with a blood substance level.

2. The device of claim 1, wherein said second electrode comprises an indifferent counter electrode that also alternates polarity.

3. The device of claim 1, wherein said transdermal system further comprises a second sampling chamber, said second sampling chamber comprising said second electrode, wherein said second electrode alternates function as both an anode and a cathode during iontophoretic sampling.

4. The device of claim 3, further comprising

means for analyzing a concentration or amount of a substance or a substance metabolite received in the second sampling chamber.

5. The device of claim 4, wherein said programmed processor provides correlation data between a substance level, in said first sampling chamber and said second sampling chamber, and blood substance levels.

6. The device of claim 3, wherein each sampling chamber comprises an Ag/AgCl electrode.

7. The device of claim 6, wherein each sampling chamber comprises a collection medium.

8. The device of claim 1, wherein said reversing of polarity is performed at a frequency comprising about 1 cycle per 20 seconds to about 1 cycle per 4 hours.

9. The device of claim 1, wherein said reversing of polarity is performed at a frequency comprising about 1 cycle per 20 seconds to about 1 cycle per 2 hours.

10. The device of claim 1, wherein said reversing of polarity is performed at a frequency comprising about I cycle per minute to about 1 cycle per2 hours.

11. The device of claim 1, wherein said reversing of polarity is preformed at a frequency comprising about 1 cycle per 10 minutes to about 1 cycle per hour.

12. The device of claim 1, wherein said reversing of polarity is performed at a frequency comprising about 1 cycle per half hour.

13. The device of claim 1, wherein the first sampling chamber comprises an Ag/AgCl electrode.

14. The device of claim 13, wherein the first sampling chamber comprises a collection medium.

15. The device of claim 1, wherein said means for reversing polarity comprises a switch.

16. The device of claim 1, further comprising an electrical power supply.

17. The device of claim 1, wherein said sample comprises glucose.

18. The device of claim 1, wherein said sample comprises more than one substance.

19. A substance sampling device, comprising

first and second substance sampling chambers for receiving a sample comprising said substance or a substance metabolite, each sampling chamber comprising an electrically conductive collection medium;

a switch (i) connectable to a power supply positive connector and a power supply negative connector, and (ii) connected to the collection medium in said first sampling chamber by a first conductor, and connected to the collection medium in said second sampling chamber by a second conductor, wherein the switch comprises a first position such that when the first sampling chamber is electrically connected to the positive connector, the second sampling chamber is electrically connected to the negative connector, and a second position such that when the second sampling chamber is electrically connected to the positive connector, the first sampling chamber is electrically connected to the negative connector, and

means for analyzing a concentration or amount of a substance or a substance metabolite received in said first sampling chamber.

20. The substance sampling device of claim 19, wherein (i) the first sampling chamber further comprises an electrode in contact with the collection medium and said first conductor, and (ii) the second sampling chamber further comprises an electrode in contact with the collection medium and said second conductor.

21. The substance sampling device of claim 20, wherein each sampling chamber comprises an Ag/AgCl electrode.

22. The substance sampling device of claim 19, wherein the electrically conductive collection medium is selected from the group consisting of saline solutions, buffer solutions, and polyols.

23. The substance sampling device of claim 19, further comprising

means for analyzing a concentration or amount of a substance or a substance metabolite received in said second sampling chamber.

24. The substance sampling device of claim 23, further comprising a programmed processor for providing correlation data between sampling chamber substance level and blood substance levels.

25. The substance sampling device of claim 19, wherein switching from said first position to said second position is performed at a frequency comprising about 1 cycle per 20 seconds to about 1 cycle per 4 hours.

26. The substance sampling device of claim 19, wherein switching from said first position to said second position is performed at frequency comprising about 1 cycle per 20 seconds to about 1 cycle per 2 hours.

27. The substance sampling device of claim 19, wherein switching from said first position to said second position is performed at a frequency comprising about 1 cycle per minute to about 1 cycle per 2 hours.

28. The substance sampling device of claim 19, wherein switching from said first position to said second position is performed at a frequency comprising about 1 cycle per 10 minutes to about 1 cycle per hour.

29. The substance sampling device of claim 19, wherein switching from said first position to said second position is performed at a frequency comprising about 1 cycle per half hour.

30. The substance sampling device of claim 19, further comprising an electrical power supply.

31. The substance sampling device of claim 19, wherein said sample comprises glucose.

32. The substance sampling device of claim 19, wherein said sample comprises more than one substance.