Percutaneous biological fluid sampling and analyte measurement devices and methods

• US 6,990,367 B2
• Filed: 02/18/2004
• Issued: 01/24/2006
• Est. Priority Date: 06/12/2001
• Status: Expired due to Term

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Leong, Koon-wah, Kiser, Ernest
• Primary Examiner(s): WOLFE JR, WILLIS RAY
• Application Number:
  US10/782,272
• Publication Number:
  US 20040162474A1
• Time in Patent Office: 706 Days
• Field of Search: 600/345, 600/347, 600/365, 600/372, 600/573, 600/583, 600/584, 204/403.11, 204/403.13, 204/403.14, 204/403.01, 205/775, 205/775.5
• US Class Current: 600/345
• 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

Abstract

A device for sampling a biological fluid and measuring at least one target constituent within the biological fluid. The device has at least one electrochemical cell having an inner electrode and an outer electrode in a concentrically-spaced relationship. In a preferred embodiment, the outer electrode has a cylindrical configuration having an open distal end and the inner electrode has an elongated configuration positioned co-axially within the outer electrode and a distal end configured to penetrate the skin. The spacing between the electrodes exerts a capillary force on biological fluid present at the open distal end of the outer electrode. A system is also provided which includes a control unit in electrical communication with the electrochemical cell for controlling the selection and measurement of the target constituent. Methods of sampling of biological fluids within the skin and measuring the sampled fluids are also provided, as well as kits comprising one or more of the inventive devices and/or systems.

Claims

1. A method for testing a biological fluid within the skin of a patient and for determining the concentration of a target constituent contained therein, the method comprising the steps of:

providing an electrochemical cell comprising concentrically spaced-apart inner and outer electrodes and a reaction chamber therebetween, wherein the positions of the inner and outer electrodes are fixed relative to each other, the outer electrode comprising a blunt distal end and the inner electrode comprising a distal end configured to pierce the skin;

inserting the distal end of the inner electrode into the skin;

contacting the skin and exerting a pressure thereon with the blunt distal end of the outer electrode; and

transferring a sample of biological fluid from the pierced skin into the reaction chamber.

2. The method of claim 1 wherein the transferring of sample biological fluid comprises exerting a capillary force on biological fluid present between the distal end of the inner electrode and the distal end of the outer electrode.

3. The method of claim 1 wherein the exerting a pressure on the skin causes the skin positioned between the inner and outer electrodes to bulge into the reaction chamber.

4. The method of claim 1 further comprising:

providing a first electrical signal to the electrochemical cell; and

receiving a second electrical signal generated by the electrochemical cell, wherein the second electrical signal is representative of the concentration of the constituent in the sample.

5. An electrochemical cell for use in sampling biological fluid and measuring an analyte therein, the cell comprising:

a first electrode comprising a continuous wall configuration having a distal edge defining a pressure ring;

a second electrode comprising an elongated configuration having a length that extends concentrically within the first electrode, wherein the positions of the first and second electrodes are fixed relative to each other, the second electrode having a distal end configured to pierce a skin surface; and

an open space between the distal edge of the first electrode and the distal end of the second electrode.

6. The electrochemical cell of claim 5 further comprising a reaction chamber defined between the first and second electrodes.

7. The electrochemical cell of claim 5 further comprising an insulating material between a proximal portion of the first electrode and a proximal portion of the second electrode.

8. The electrochemical cell of claim 5 wherein the pressure ring is circular.

9. The electrochemical cell of claim 5 wherein the pressure ring is elliptical.

10. The electrochemical cell of claim 5 wherein the pressure ring is oblong.