Method for transdermal sampling of analytes

• US 6,383,138 B1
• Filed: 02/26/2001
• Issued: 05/07/2002
• Est. Priority Date: 02/25/2000
• Status: Expired due to Fees

• Current Assignee: Health Research Incorporated
• Original Assignee: Health Research Incorporated
• Inventors: Sen, Arindam, Hui, Sek Wen, Zhao, Ya Li
• Primary Examiner(s): Shaver, Kevin
• Assistant Examiner(s): Marmor, II, Charles
• Application Number:
  US09/793,257
• Time in Patent Office: 435 Days
• Field of Search: 600/345, 600/347, 600/365, 600/372, 600/573, 600/584, 435/14, 204/403, 604/20-22, 604/289, 604/290
• US Class Current: 600/365
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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

Abstract

The present invention discloses a method for transdermal extraction and measurement of analytes in an individual'"'"'s body comprising the steps of permeabilizing the skin by electroporation in the presence of liposomes comprising negatively charged lipids, and extracting the extracellular fluid through the permeabilized skin by using suction. Analytes may be quantitated in the extracted extracellular fluid.

Claims

1. A method for measuring an analyte in an individual'"'"'s body comprising the steps of:

a. contacting a region of the skin from the individual with a liposomal composition comprising negatively charged lipids;

b. applying at least one electric pulse to the region of the skin where the liposomal composition has been contacted;

c. applying suction to said region of the skin where the electric pulse has been applied to extract fluid from the individual;

d. measuring the analyte in the extracted fluid, and

e. correlating the analyte level in the extracted fluid to the level of the analyte in the individuals body.

2. The method of claim 1, wherein the liposomal composition comprises dioleylphosphatidylglycerol.

3. The method of claim 2, wherein the liposomal composition further comprises dioleylphosphatidylcholine.

4. The method of claim 3, wherein the dioleylphosphatidylglycerol and the dioleylphosphatidylcholine are present in about a 1:

1 ratio.

5. The method of claim 1, wherein the analyte is glucose.

6. The method of claim 1, wherein the electric pulse is applied for a duration of about 10 μ

sec to about 10 msec and the voltage drop across each skin passage is about 30V to about 180V.

7. A method for measuring an analyte in an individual'"'"'s body comprising the steps of:

(a) applying at least one electric pulse in the presence of a liposomal composition to a region of the skin of the individual, wherein the liposomal composition comprises negatively charged lipids;

(b) applying suction to said region of the skin to extract fluid from the individual;

(c) measuring the analyte in the extracted fluid; and

(d) correlating the level of the analyte in the extracted fluid to the level in the individual'"'"'s body.

8. The method of claim 7, wherein the liposomal composition comprises dioleylphosphatidylglycerol.

9. The method of claim 8, wherein the liposomal composition further comprises dioleylphosphatidylcholine.

10. The method of claim 9, wherein the dioleylphosphatidylglycerol and the dioleylphosphatidylcholine are present in about a 1:

1 ratio.

11. The method of claim 7, wherein the analyte is glucose.

12. The method of claim 7, wherein the electric pulse is applied for a duration of about 10 μ

sec to about 10 msec and the voltage drop across each skin passage is about 30V to about 180V.

13. A method for extracting extracellular fluid through the skin of an individual comprising the steps of:

(a) placing a negative electrode and appositive electrode on the skin, wherein the negative electrode also contains a reservoir, wherein the reservoir contains a liposomal composition comprising negatively charged lipids;

(b) applying at least one electric pulse through the electrodes;

(c) applying suction to the region of the skin where electric pulse has been applied to collect the extracellular fluid.

14. The method of claim 13, wherein the liposomal composition comprises dioleylphosphatidylglycerol.

15. The method of claim 14, wherein the liposomal composition further comprises dioleylphosphatidylcholine.

16. The method of claim 15, wherein the dioleylphosphatidylglycerol and the dioleylphosphatidylcholine are present in about a 1:

1 ratio.

17. The method of claim 13, wherein the electric pulse is applied for a duration of about 10 μ

sec to about 10 msec and the voltage drop across each skin passage is about 30V to about 180V.

18. A method of detecting the presence of an analyte in an individual'"'"'s body comprising the steps of:

a. contacting a region of the skin from the individual with a liposomal composition comprising negatively charged lipids;

b. applying at least one electric pulse to the region of the skin where the liposomal composition has been contacted;

c. applying suction to said region of the skin where the electric pulse has been applied to extract fluid from the individual;

d. detecting the presence of the analyte in the extracted fluid,

wherein the presence of the analyte in the extracted fluid is an indication of the presence of the analyte in the individual'"'"'s body.

19. The method of claim 18, wherein the liposomal composition comprises dioleylphosphatidylglycerol.

20. The method of claim 19, wherein the liposomomal composition further comprises dioleylphosphatidylcholine.

21. The method of claim 20, wherein the dioleylphosphatidylglycerol and the dioleylphosphatidylcholine are present in about a 1:

1 ratio.

22. The method of claim 18, wherein the electric pulse is applied for a duration of about 10 μ

sec to about 10 msec and the voltage drop across each skin passage is about 30V to about 180V.