Method and apparatus for obtaining interstitial fluid for diagnostic tests

• US 6,155,992 A
• Filed: 12/02/1997
• Issued: 12/05/2000
• Est. Priority Date: 12/02/1997
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Tarkowski, Brian J., Henning, Timothy P., Shain, Eric B., Young, Douglas F., Cunningham, David D., Hiltibran, Robert G.
• Primary Examiner(s): HINDENBURG, MAX F
• Application Number:
  US08/982,449
• Time in Patent Office: 1,099 Days
• Field of Search: 600/583, 600/573, 606/180-183
• US Class Current: 600/583
• 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 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: 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

A method and apparatus for obtaining a sample of interstitial fluid from a patient for subsequent diagnostic tests, e.g., glucose monitoring. In one aspect of the invention, the method comprises the steps of (a) treating an area of the skin with vacuum or heat or both vacuum and heat to increase the availability of interstitial fluid at that area of the skin; (b) forming an opening in the treated area of the skin; and (c) extracting the sample of interstitial fluid from the opening in the skin, with the aid of vacuum and stretching of the skin. In another aspect of the invention, an apparatus for carrying out the method described previously is provided. Th apparatus comprises (a) a device for forming an unobstructed opening in the area of the skin from which the sample is to be extracted, preferably a lancing assembly; and (b) a vacuum pump. Preferably, the apparatus also includes a housing.

Claims

1. A method for obtaining a sample of interstitial fluid for a diagnostic test, said method comprising the steps of:

(a) treating an area of the skin with vacuum or heat or both vacuum and heat to increase the availability of interstitial fluid at that area of the skin;

(b) forming an unobstructed opening in the treated area of the skin; and

(c) extracting the sample of interstitial fluid from the unobstructed opening in the skin, with the aid of vacuum and stretching of the skin.

2. The method of claim 1, wherein said diagnostic test is a test to determine the concentration of glucose in a biological fluid.

3. The method of claim 1, further comprising the step of increasing the availability of interstitial fluid to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

4. The method of claim 3, wherein a vacuum is used to increase the availability of interstitial fluid to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

5. The method of claim 4, wherein stretching is used to increase the availability of interstitial fluid to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

6. The method of claim 3, wherein heat is used to increase the availability of interstitial fluid to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

7. The method of claim 4, wherein heat is used to increase the availability of interstitial fluid to said area of said skin from which said sample is to be extracted prior to forming said opening in said area of said skin from which said sample is to be extracted.

8. The method of claim 1, wherein said opening in said area of said skin from which the sample is to be extracted is formed by a rotating opening-forming device.

9. The method of claim 8, wherein said rotating opening-forming device is a drill.

10. The method of claim 8, wherein said rotating opening-forming device is a lancet.

11. The method of claim 1, wherein said extracted sample is analyzed by means of a glucose detector.

12. The method of claim 11, wherein said glucose detector employs an optical meter.

13. The method of claim 11, wherein said glucose detector employs an electrochemical meter.

14. The method of claim 8, wherein said rotating drill penetrates said skin to a depth of no more than 1.0 mm.

15. The method of claim 1, wherein said opening in said area of said skin from which the sample is to be extracted is formed by a laser.

16. The method of claim 1, wherein said interstitial fluid is obtained from a part of the body other than a finger.

17. The method of claim 1, wherein said interstitial fluid is obtained at a pain level lower than that experienced when a finger is pierced by a standard finger lancet.

18. An apparatus suitable for obtaining a sample of interstitial fluid for analysis in a diagnostic test, said apparatus comprising:

(a) a device for forming an unobstructed opening in an area of skin from which said sample is to be extracted;

(b) a vacuum pump for extracting said sample from said unobstructed opening in said area of said skin; and

(c) a nosepiece having an end that contacts said area of said skin, said end being equipped with a seal, said seal surrounding an opening in said nosepiece, said opening allowing communication between said area of said skin and an interstitial fluid extraction chamber in said nosepiece, said seal preventing air from leaking into said interstitial fluid extraction chamber, so that said vacuum pump can provide sufficient suction action for increasing availability of interstitial fluid to said area of said skin from which said sample is to be obtained, for stretching said skin, and for extracting said sample of interstitial fluid from said unobstructed opening in said area of said skin.

19. The apparatus of claim 18, further including a housing.

20. The apparatus of claim 19, wherein said device for forming said unobstructed opening comprises a lancing assembly.

21. The apparatus of claim 18, wherein said device for forming said unobstructed opening is a laser.

22. The apparatus of claim 18, wherein said device for forming said unobstructed opening is a lancing assembly.

23. The apparatus of claim 22, wherein said lancing assembly comprises a lancet capable of being rotated.

24. The apparatus of claim 23, wherein said lancet is capable of being retracted after it forms said unobstructed opening in said skin.

25. The apparatus of claim 22, wherein said lancing assembly comprises a drill capable of being rotated.

26. The apparatus of claim 25, wherein said drill is capable of being retracted after it forms said unobstructed opening in said skin.

27. The apparatus of claim 18, further comprising a heating element.

28. The apparatus of claim 18, further comprising a glucose detector.

29. The apparatus of claim 28, wherein said glucose detector can utilize an electrochemical meter.

30. The apparatus of claim 28, wherein said glucose detector can utilize an optical meter.

31. The apparatus of claim 18, wherein said vacuum is applied through said opening in said nosepiece, said opening having an area up to 5 cm².

32. A method for obtaining a sample of interstitial fluid for a diagnostic test, said method comprising the steps of:

(1) first treating an area of the skin with vacuum or heat or both vacuum and heat to increase the availability of interstitial fluid at that area of the skin;

(2) then forming an unobstructed opening in the treated area of the skin; and

(3) then extracting the sample of interstitial fluid from the unobstructed opening in the skin, with the aid of vacuum and stretching of the skin.