Fluid collection and monitoring device

• US 6,679,841 B2
• Filed: 06/15/2001
• Issued: 01/20/2004
• Est. Priority Date: 02/17/1998
• Status: Expired due to Term

• Current Assignee: Abbott Laboratories Incorporated, Spectro Incorporated (Spectro Scientific, Inc.)
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Eppstein, Jonathan A., Henning, Timothy P., Loomis, Neil W., Pope, Mark R., Bojan, Peter M.
• Primary Examiner(s): WINAKUR, ERIC FRANK
• Application Number:
  US09/880,948
• Publication Number:
  US 20020099308A1
• Time in Patent Office: 949 Days
• Field of Search: 600/309, 600/310, 600/344, 600/345, 600/348, 600/362, 600/573, 600/584, 422/68.1, 422/82.01, 422/82.05, 204/403.01, 204/403.02
• US Class Current: 600/309
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 18/20 using laser
• 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
• CPC Class Codes: A61B 2018/1807 using light other than laser radiation
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150343 Collection vessels for collecting blood samples from the skin surface, e.g. test tubes, cuvettes sampling from within body cavities A61B5/150015, A61B5/150045
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/441 Skin evaluation, e.g. for skin disorder diagnosis
• CPC Class Codes: Y10T 436/2575 Volumetric liquid transfer

Abstract

An article capable of both collecting interstitial fluid and detecting an analyte in that fluid and a method for use of that article. Preferably, the article is also capable of measuring the amount of analyte in the interstitial fluid. The article can be used in conjunction with a meter that contains an appropriate detection element for determining the amount of analyte in the interstitial fluid. In one preferred embodiment, the article is a multiple-layer element comprising:

(1) a layer that is capable of being placed in contact with the skin of a patient;

(2) a layer that is coated over the skin-contacting layer;

(3) a layer, substantially coplanar with the overcoat layer, that is capable of transporting interstitial fluid by means of chemically aided wicking;

(4) a layer, overlying the interstitial fluid transporting layer, that is capable of being placed in contact with a meter, said layer having an opening therein through which light can be transmitted;

(5) a layer, disposed on the surface of the meter-contacting layer that faces the skin-contyacting layer, that is capable of detecting the presence of analyte or measuring the amount of analyte in the fluid.

In order to use the multiple-layer element, light from a source of light is transmitted through the opening in the multiple-layer material to be absorbed at a light-absorbing target on the skin-contacting layer. This light transfers energy to the target, and this transferred energy causes an opening to form in the skin-contacting layer and an opening to form in the stratum corneum. Interstitial fluid exudes from the opening in the stratum corneum and contacts the interstitial fluid transporting layer. The interstitial fluid then moves along or through the interstitial fluid transporting layer to the detecting layer.

Claims

1. Method for collecting interstitial fluid and analyzing said fluid for an analyte, said method comprising the steps of:

(a) providing a multiple-layer element comprising;

(1) a layer that is capable of being placed in contact with the skin of a patient;

(2) an overcoat layer that is coated over the skin-contacting layer;

(3) a layer, substantially coplanar with the overcoat layer, that is capable of transporting interstitial fluid by means of chemically aided wicking;

(4) a layer, overlying the interstitial fluid transporting layer, that is capable of being placed in contact with a meter, said layer having an opening therein through which light can be transmitted;

(5) a layer in communication with the interstitial fluid transporting layer, which layer is capable of detecting the presence of analyte or measuring the amount of analyte in the fluid;

(b) placing said element in contact with the skin;

(c) providing a source of light;

(d) transmitting light through said multiple-layer element such that said light causes an opening to be formed in the skin;

(e) collecting interstitial fluid in said fluid transporting layer;

(f) transporting interstitial fluid to said analyte detecting layer;

(g) detecting the presence of an analyte or measuring the amount of analyte in the fluid.

2. The method of claim 1, wherein said skin-contacting layer has a target for said light.

3. The method of claim 2, wherein said target comprises a dye or a pigment.

4. The method of claim 1, wherein said skin-contacting layer bears an adhesive on one major surface thereof.

5. The method of claim 1, wherein said interstitial fluid-transporting layer is transparent to said light.

6. The method of claim 1, wherein said interstitial fluid-transporting layer is a mesh.

7. The method of claim 1, wherein said interstitial fluid transporting layer comprises a surfactant.

8. The method of claim 1, wherein said interstitial fluid-transporting layer has an opening therein.

9. The method of claim 1, wherein said interstitial fluid-transporting layer and said overcoat layer are substantially coplanar.

10. The method of claim 1, wherein said interstitial fluid transporting layer has edges, said edges being embedded in said overcoat layer.

11. The method of claim 1, wherein said analyte-detecting layer detects analyte by means of an electrical measurement.

12. The method of claim 1, wherein said analyte-detecting layer detects analyte by means of an optical measurement.

13. The method of claim 1, wherein said source of light is a laser.

14. The method of claim 1, wherein said source of light is a pulsed high intensity white light.

15. The method of claim 1, wherein the amount of interstitial fluid collected is less than two microliters.

16. The method of claim 1, wherein the amount of interstitial fluid collected is less than one microliter.

17. Article for collecting and analyzing interstitial fluid to detect the presence of an analyte therein comprising:

a multiple-layer element comprising;

(1) a layer that is capable of being placed in contact with the skin of a patient;

(2) an overcoat layer that is coated over the skin-contacting layer;

(3) a layer, substantially coplanar with the overcoat layer, that is capable of transporting interstitial fluid by means of chemically aided wicking;

(4) a layer, overlying the interstitial fluid transporting layer, that is capable of being placed in contact with a meter, said layer having an opening therein through which light can be transmitted;

(5) a layer in communication with the interstitial fluid transporting layer, which layer is capable of detecting the presence of analyte or measuring the amount of analyte in the fluid.

18. The article of claim 17, wherein said skin-contacting layer has a target for light.

19. The article of claim 18, wherein said target comprises a dye or a pigment.

20. The article of claim 18, wherein said skin-contacting layer bears an adhesive on one major surface thereof.

21. The article of claim 17, wherein said interstitial fluid-transporting layer is transparent to light.

22. The article of claim 17, wherein said interstitial fluid-transporting layer is a mesh.

23. The article of claim 17, wherein said interstitial fluid transporting layer comprises a surfactant.

24. The article of claim 17, wherein said interstitial fluid-transporting layer has an opening therein.

25. The article of claim 17, wherein said interstitial fluid-transporting layer and said overcoat layer are substantially coplanar.

26. The article of claim 17, wherein said interstitial fluid-transporting layer has edges, said edges being embedded in said overcoat layer.

27. The article of claim 19, wherein said analyte-detecting layer detects analyte by means of an electrical measurement.

28. The article of claim 17, wherein said analyte-detecting layer detects analyte by means of an optical measurement.

29. The article of claim 18, wherein said light is provided by a laser.

30. The article of claim 18, wherein said light is provided by a pulsed high intensity white light.

31. The article of claim 17, wherein no more than two microliters of interstitial fluid are required for analyte determination.

32. The article of claim 17, wherein no more than one microliter of interstitial fluid is required for analyte determination.