Electrochemical sensor and method for manufacturing

• US 9,746,440 B2
• Filed: 05/07/2015
• Issued: 08/29/2017
• Est. Priority Date: 08/30/2007
• Status: Active Grant

• Current Assignee: Pepex Biomedical, Inc.
• Original Assignee: Pepex Biomedical, LLC
• Inventors: Say, James L.
• Primary Examiner(s): Van, Luan
• Assistant Examiner(s): Kessel, Maris R
• Application Number:
  US14/706,123
• Publication Number:
  US 20150233863A1
• Time in Patent Office: 845 Days
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• 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: G01N 27/3272 Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52

Abstract

A sensor includes a sheath that is elongated along a longitudinal axis; a spacer positioned within the sheath and defining first and second channels having lengths that extend along the longitudinal axis; a first elongated member positioned within the first channel; and a second elongated member positioned within the second channel. The first elongated member includes an active surface forming a working electrode and the second elongated member including an active surface defining a counter electrode.

Claims

1. A sensor for sensing an analyte in a sample comprising:

an outer member that is elongated along a longitudinal axis, the longitudinal axis extending between a distal end and a proximal end of the outer member, the distal end including an opening for allowing entrance of a test sample into the outer member;

an elongated spacer positioned within the outer member, the elongated spacer having an axial length that extends along the longitudinal axis of the outer member;

a first elongated electrode supported by the elongated spacer, the first elongated electrode defining a working electrode having a sensing layer; and

a second elongated electrode supported by the elongated spacer, the second elongated electrode defining a counter electrode, a reference electrode, or a combined reference and counter electrode;

the first and second elongated electrodes being elongated along axial lengths that extend along the axial length of the elongated spacer;

the elongated spacer being sized and configured to separate the first elongated electrode from the second elongated electrode and to provide open space extending along the longitudinal axis between the outer member and the first and second elongated electrodes through which the test sample can flow, the sensing layer being accessible within the open space and having an axial dimension that extends along the axial length of the elongated spacer, wherein the elongated spacer, the outer member and the sensing layer are configured to enable the sensing layer to be progressively wetted along its axial dimension by the test sample as the test sample moves longitudinally through the open space from the distal end toward the proximal end of the outer member.

2. The sensor of claim 1, wherein the second elongated electrode is a reference electrode, and the sensor also includes a counter electrode.

3. The sensor of claim 1, wherein the second elongated electrode is a counter electrode, and the sensor also includes a reference electrode.

4. The sensor of claim 1, wherein the elongated spacer is constructed of a dielectric material.

5. The sensor of claim 1, wherein the outer member is a sheath.

6. A sensor for sensing an analyte in a sample comprising:

an outer member that is elongated along a longitudinal axis;

a spacer positioned within the outer member, the spacer having an axial length that extends along the longitudinal axis;

an elongated electrode supported by the spacer, the elongated electrode having a length that extends along the axial length of the spacer, the elongated electrode defining a working electrode having a sensing layer;

the spacer being sized and configured to provide open spacing extending along the longitudinal axis between the outer member and the sensing layer of the working electrode through which a test sample can flow, the sensing layer having an axial dimension extending along the axial length of the spacer, and the sensing layer being wetted along its axial dimension by the test sample as the test sample moves longitudinally through the open spacing.

7. The sensor of claim 6, wherein the spacer is constructed of a dielectric material.

8. The sensor of claim 6, wherein the outer member includes an insulating sheath.