Biological fluid constituent sampling and measurement devices

• US 7,361,307 B2
• Filed: 07/07/2004
• Issued: 04/22/2008
• Est. Priority Date: 06/12/2001
• Status: Expired due to Fees

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Shartle, Robert, Kiser, Ernest J., Leong, Koon-wah
• Primary Examiner(s): ALEXANDER, LYLE
• Application Number:
  US10/886,789
• Publication Number:
  US 20040249310A1
• Time in Patent Office: 1,385 Days
• Field of Search: None
• US Class Current: 422/82.01
• 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 5/14532 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: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: Y10T 436/144444 Glucose

Abstract

A device for accessing biological fluid, sampling biological fluid constituents and determining the concentration of at least one target constituent within the accessed biological fluid is provided. The device has at least one micro-piercing member used to penetrate the skin to a selected depth and to access biological fluid, a constituent sampling means and a constituent measuring means. The constituent sampling means comprises a constituent transfer medium, such as a hydrophilic gel material, by which sampled constituents are transferred from the micro-piercing member to the measuring means. The measuring means includes an electrochemical cell having at least one porous electrode through which at least one sampled constituent is caused to enter into the electrochemical cell. Methods of sampling constituents within the skin and measuring the sampled constituents, as well as kits for practicing the invention are provided.

Claims

1. A biological fluid constituent sampling and concentration measurement device, said device comprising:

(a) an array of micro-needles, each micro-needle having an access opening;

(b) a layer of hydrophilic gel material over the array;

(c) a first layer of conductive material over the layer of hydrophilic gel material, wherein the first layer of conductive material is porous and further wherein the access openings, the layer of hydrophilic gel material and the first layer of conductive material provide a constituent transfer pathway;

(d) a second layer of conductive material, wherein the first layer of conductive material and the second layer of conductive material are spaced-apart, wherein biological fluid present at the access opening is caused to be transferred to the space between the first and second layers of conductive material; and

(e) a control unit to calculate the concentration of an analyte in the biological fluid transferred between the first layer and the second layers of conductive material.

2. The device of claim 1 further comprising a layer of insulating material over the second layer of conductive material.

3. The device of claim 1 wherein the array of micro-needles comprises an insulating material.

4. The device of claim 1 further comprising a layer of at least one reagent material between the first and second layers of conductive material, wherein at least one biological fluid constituent present in the space between the first and second layers of conductive material chemically reacts with the at least one reagent material.

5. The device of claim 4 wherein the layer of at least one reagent material contacts either the first layer of conductive material, the second layer of conductive material or both.

6. The device of claim 1 wherein the second layer of conductive material is porous.

7. The device of claim 6 further comprising an insulating layer over the second layer of porous conductive material, wherein the insulating layer has a venting hole there through.

8. The device of claim 1 wherein the biological fluid being accessed is interstitial fluid and the constituent being measured is glucose.

9. The device of claim 8 wherein the reagent comprises a glucose oxidizing enzyme and a mediator.

10. The device of claim 9 wherein the enzyme is selected from a group consisting of glucose oxidase and glucose dehydrogenase.

11. The device of claim 10 wherein the mediator is ferricyanide.

12. The device of claim 1 wherein the micro-needles of the array of micro-needles have varying lengths.