Percutaneous biological fluid constituent sampling and measurement devices and methods

• US 6,793,632 B2
• Filed: 06/12/2001
• Issued: 09/21/2004
• 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: Sohrab, Borzu
• Primary Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/878,742
• Publication Number:
  US 20020188221A1
• Time in Patent Office: 1,197 Days
• Field of Search: 600/573, 600/584, 600/575, 600/576, 600/345-358, 600/365, 600/366, 600/372, 600/373, 600/393, 606/185, 606/186, 422/68.1, 422/82-1-, 435/14, 436/149, 436/150, 204/400, 204/403.01
• US Class Current: 600/573
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/150282 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150503 Single-ended needles hollow piercing element tip design A61B5/150396, needle sets for catheters A61M25/06, needles for bringing media into the body A61M5/32
• 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 5/15186 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: A61B 5/685 Microneedles

Abstract

A device for sampling at least one biological fluid constituent and measuring at least one target constituent within the biological fluid. The device has at least one micro-needle having an open distal end used to penetrate the skin to a depth where pain and bleeding are minimized. The device further includes a hydrophilic gel within the micro-needle for sampling the biological fluid constituents and an electrochemical cell for measuring the concentration of targeted constituents within the sampled biological fluid constituents. In certain embodiments, the electrochemical cell is integrated within the micro-needle whereby the steps of sampling and measuring are performed completely in-situ. In other embodiments, the electrochemical cell is located external to the micro-needle at its proximal end. Constituent sampling and measurement systems, methods and kits are also provided.

Claims

1. A system for sampling biological fluid constituents from the skin of a patient and measuring a target constituent within the biological fluid, the system comprising:

(a) a micro-needle at least a portion of which is hollow and having an open distal end for accessing the biological fluid;

(b) an electrochemical cell associated with the micro-needle, the cell comprising an outer electrode and an inner electrode wherein the electrodes each have a cylindrical configuration and are spaced from each other in a co-axial relationship, the micro-needle formed at least partially by the outer electrode;

(c) a water-absorbent gel matrix at least partially contained within the hollow portion of the micro-needle and the space between the electrodes; and

(d) a control unit in electrical communication with the electrochemical cell for measuring the concentration of the target constituent of the biological fluid.

2. The system according to claim 1 further comprising a display unit in electrical communication with the control unit for displaying information related to the measuring of the target constituent.

3. The system according to claim 1 further comprising a housing and a support means wherein the control unit is housed within the housing and the micro-needle is mounted to the support means.

4. The system of claim 1 wherein the gel matrix comprises a natural gel.

5. The system of claim 4 wherein the natural gel is selected from the group comprising agarose, gelatin, mucopolysaccharide and starch.

6. The system of claim 1 wherein the gel matrix comprises a synthetic gel.

7. The system of claim 6 wherein the synthetic gel comprises a neutral water-soluble polymer.

8. The system of claim 1 wherein the electrochemical cell is adjacent to a proximal end of the micro-needle.

9. The system of claim 1 comprising an array of micro-needles.

10. The system of claim 1 wherein the outer electrode is a reference electrode and the inner electrode is a working electrode, and further wherein the control unit comprises:

means for sending an electrical reference signal to the reference electrode and for receiving an electrical output signal from the working electrode; and

means for automatically determining the concentration of the target constituent in the biological fluid upon receipt of the electrical output signal.

11. The system of claim 1 wherein the outer electrode and the inner electrode have substantially the same length.

12. The system of claim 1 wherein the outer electrode is longer than the inner electrode.