Non- or minimally invasive monitoring methods

• US 6,602,678 B2
• Filed: 12/17/2001
• Issued: 08/05/2003
• Est. Priority Date: 09/04/1998
• Status: Expired due to Fees

• Current Assignee: Powderject Research Limited (Pfizer Inc.)
• Original Assignee: Powderject Research Limited (Pfizer Inc.)
• Inventors: Burkoth, Terry L., Kwon, Sung Yun
• Primary Examiner(s): Leary, Louise N.
• Application Number:
  US10/022,633
• Publication Number:
  US 20020102625A1
• Time in Patent Office: 596 Days
• Field of Search: 435/14, 435/4, 435/283.1, 435/25
• US Class Current: 435/14
• CPC Class Codes: A61B 17/545 using a stream or spray of abrasive particles
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 2017/00747 Dermatology
• 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 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

An apparatus for sensing an analyte is described, wherein the apparatus includes an interface contact element that is used to establish an interface with a quantity of body fluid. The interface contact element is adapted to facilitate diffusion of a target analyte across the interface essentially free of net mass fluid transport. The quantity of body fluid is exposed to the interface contact element through micro-pathways. The apparatus can also include a sensing material adapted to sense the target analyte with at least one analytical method. Methods for using the apparatus in a non- or minimally invasive monitoring technique are also described.

Claims

1. A sensor for measuring or detecting a target analyte, said sensor comprising an interface contact element that is capable of establishing an interface with a quantity of body fluid containing or suspected of containing the analyte, wherein said interface contact element is adapted to diffusion of the analyte essentially free of net mass fluid transport across said interface, characterized in that said interface contact element comprises an aqueous component that is isosmotic with the body fluid.

2. The sensor of claim 1, wherein said interface contact element further comprises a specific concentration of an inorganic salt also found in the body fluid.

3. The sensor of claim 1 further comprising a sensing material that is capable of specifically detecting the presence, or both the presence and amount of analyte present in the interface contact element.

4. The sensor of claim 1, wherein the interface contact element is adapted for placement upon a target skin surface.

5. A sensor for measuring or detecting a target analyte, said sensor comprising an interface contact element that is capable of establishing an interface with a quantity of body fluid containing or suspected of containing the analyte, wherein said interface contact element is adapted to diffusion of the analyte essentially free of net mass fluid transport across said interface, characterized in that said interface contact element comprises a specific concentration of the target analyte prior to being interfaced with the quantity of body fluid.

6. The sensor of claim 5, wherein the target analyte is glucose.

7. The sensor of claim 6, wherein the interface contact element comprises from 0.05 to 0.5% glucose by weight of said interface contact element.

8. The sensor of claim 7 wherein the interface contact element comprises from 0.08% to 0.3% glucose by weight of said interface contact element.

9. The sensor of claim 7 wherein the interface contact element comprises 0.1% glucose by weight of said interface contact element.

10. The sensor of claim 6, wherein the interface contact element comprises an amount of glucose equivalent to from 60 to 120 mg/dl glucose in blood.

11. The sensor of claim 6, wherein the interface contact element comprises an amount of glucose equivalent to less than 60 mg/dl glucose in blood.

12. The sensor of claim 6, wherein the interface contact element comprises an amount of glucose equivalent to greater than 120 mg/dl glucose in blood.

13. The sensor of claim 5, wherein said interface contact element comprises an aqueous component that is isosmotic with the body fluid.

14. The sensor of claim 13, wherein said interface contact element further comprises a specific concentration of an inorganic salt also found in the body fluid.

15. The sensor of claim 5 further comprising a sensing material that is capable of specifically detecting the presence, or both the presence and amount of analyte present in the interface contact element.

16. The sensor of claim 5, wherein the interface contact element is adapted for placement upon a target skin surface.

17. A method for measuring or detecting a target analyte in a quantity of body fluid containing or suspected of containing the analyte, said method comprising:

(a) exposing a quantity of body fluid through a micro-pathway created in a tissue surface;

(b) providing an interface contact element;

(c) establishing an interface at the tissue surface between the body fluid exposed through the micropathway and the interface contact element;

(d) allowing said analyte to diffuse across said interface into the interface contact element, wherein diffusion of the analyte occurs essentially free of net mass fluid transport across said interface; and

(e) measuring or detecting target analyte that has diffused into the interface contact element.

18. The method of claim 17, wherein diffusion of the target analyte into the interface contact element is sufficient to approach continuous equilibrium of analyte concentration between the interface contact element and the quantity of body fluid.

19. The method of claim 17, wherein the micro-pathway is created in a skin tissue surface.

20. The method of claim 19, wherein the micro-pathway is created through the stratum corneum layer of the skin tissue.

21. The method of claim 17, wherein the micro-pathway is created using a particle injection device.

22. The method of claim 17, wherein the interface contact element is adapted to diffusion of the analyte essentially free of net mass fluid transport across said interface.

23. The method of claim 22, wherein the interface contact element comprises an aqueous component that is isosmotic with the body fluid.

24. The method of claim 22, wherein the interface contact element comprises a specific concentration of the target analyte prior to being interfaced with the quantity of body fluid.

25. The method of claim 17, wherein the concentration of the target analyte in the interface contact element is measured between predetermined time intervals.

26. The method of claim 17, wherein the concentration of the target analyte in the interface contact element is measured continuously.

27. The method of claim 17 wherein the body fluid comprises interstitial fluid.

28. The method of claim 17 wherein the target analyte is glucose.