Sensor with increased biocompatibility

• US 8,180,423 B2
• Filed: 03/29/2006
• Issued: 05/15/2012
• Est. Priority Date: 09/30/2003
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Buck, Harvey B. Jr., Garrison, Michael D., Mang, Andre, Jernigan, Walter
• Primary Examiner(s): MALLARI, PATRICIA C
• Application Number:
  US11/392,134
• Publication Number:
  US 20070007133A1
• Time in Patent Office: 2,239 Days
• Field of Search: 600/345, 600/347, 600/365, 204/403.01
• US Class Current: 600/345
• CPC Class Codes: A61B 2562/02 Details of sensors specially adapted for in-vivo measurements
• 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: C12Q 1/006 for glucose

Abstract

Sensors and methods for producing them are disclosed. A cavity is created and filled with a reagent that includes a conductive matrix, enzyme, catalyst, and binding agent, in a preferred embodiment. The cavity is substantially enclosed, leaving enough of an opening to allow the sample to enter. A portion of the material surrounding the cavity is preferably permeable to a substance useful for measuring reaction, but not to the reagent or the sample. Cavities that have the shape of a cone, conical frustum, pyramidal frustum, and right circular cylinder are given as examples. Other systems include a membrane that contains the sensor'"'"'s active area and defines an internal volume of fluid, where the membrane or internal volume has a particular geometric relationship to the active area.

Claims

1. An electrochemical sensor, comprising:

a substrate at least partially defining a cavity;

an oxygen-permeable material adjacent the cavity;

a reference electrode; and

a working electrode substantially filling the cavity, the working electrode comprising a catalyst, a porous conducting matrix and an enzyme;

wherein the reference electrode is electrically connectable to the working electrode through a liquid sample,

the cavity having a smaller opening, and a larger opening having an area at least as large as that of the smaller opening, and the smaller opening being open sufficiently to allow analyte to pass into the cavity, wherein the larger opening is adjacent the oxygen-permeable material.

2. The electrochemical sensor of claim 1, wherein the smaller opening is circular.

3. The electrochemical sensor of claim 1, wherein the larger opening is circular.

4. The electrochemical sensor of claim 3, wherein the smaller opening is circular.

5. An electrochemical sensor, comprising:

a substrate at least partially defining a cavity;

a reference electrode; and

a working electrode substantially filling the cavity, the working electrode comprising a catalyst, a porous conducting matrix and an enzyme;

wherein the reference electrode is electrically connectable to the working electrode through a liquid sample and wherein the catalyst comprises manganese dioxide.

6. The electrochemical sensor of claim 5 in which the conducting matrix comprises carbon particles.

7. A strip for testing the concentration or presence of an analyte, comprising:

a first layer having

a top surface and a bottom surface,

a contact end and a sensing end,

a first contact and a second contact at or near the contact end,

a first electrode location at or near the sensing end;

a second electrode location near the first electrode location, and

a cavity within and defined by the first layer at the first electrode location, the cavity having an opening through the top surface;

at least two conductors on the first layer, including

a first conductor electrically connecting the cavity and the first contact, and

a second conductor electrically connecting the second electrode location and the second contact;

a conductive matrix filling at least about 20% of the cavity'"'"'s volume, the matrix comprising a reagent; and

a reference electrode at the second electrode location,

wherein the first conductor extends into the cavity to at least partially define the cavity.

8. An electrochemical sensor, comprising:

a substrate having first and second surfaces and at least partially defining a cavity extending between the first and second surfaces;

a reference electrode;

an oxygen-permeable material adjacent the cavity; and

a working electrode substantially filling the cavity, the working electrode comprising a porous conducting matrix,

wherein the cavity has a smaller opening and a larger opening that has an area at least as large as that of the smaller opening, the smaller opening being open at the first surface of the substrate sufficiently to allow analyte to pass into the cavity, the larger opening being adjacent the oxygen-permeable material;

wherein the reference electrode is electrically connectable to the working electrode through a liquid sample.

9. A strip for testing the concentration or presence of an analyte, comprising:

a first layer having

a top surface and a bottom surface,

a contact end and a sensing end,

a first contact and a second contact at or near the contact end,

a first electrode location at or near the sensing end;

a second electrode location near the first electrode location, and

a cavity within and defined by the first layer at the first electrode location, the cavity having an opening through the top surface, the cavity being substantially surrounded, except at the opening, by one or more materials that are non-permeable by the analyte, at least one of the one or more materials being permeable to a co-reactant to the reagent;

at least two conductors on the first layer, including

a first conductor electrically connecting the cavity and the first contact, and

a second conductor electrically connecting the second electrode location and the second contact;

a conductive matrix filling at least about 20% of the cavity'"'"'s volume, the matrix comprising a reagent; and

a reference electrode at the second electrode location.

10. The strip of claim 9, wherein the conductive matrix fills at least about 80% of the cavity'"'"'s volume.

11. The strip of claim 9, wherein the first conductor extends into the cavity to at least partially define the cavity.

12. The strip of claim 9, wherein the first conductor is disposed along the bottom surface of the first layer.

13. The strip of claim 9, wherein the conductive matrix fills at least about 80% of the cavity'"'"'s volume.

14. The strip of claim 9, wherein the conductive matrix substantially fills the cavity.

15. The strip of claim 9, wherein at least one of the one or more materials is oxygen-permeable.

16. The strip of claim 15, wherein one or more of the at least one oxygen-permeable material has a side disposed adjacent to the bottom surface of the first layer.

17. The strip of claim 15, wherein the material that is oxygen-permeable is adjacent to the bottom surface of the first layer.