Lancet analyte sensors and methods of manufacturing

• US 9,022,953 B2
• Filed: 09/17/2009
• Issued: 05/05/2015
• Est. Priority Date: 09/19/2008
• Status: Expired due to Fees

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Fei, Jiangfeng, Gifford, Raeann, Peteu, Serban, Ripley, Paul M., Sun, Hoi-Cheong Steve, Wu, Mu
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/119,344
• Publication Number:
  US 20110172559A1
• Time in Patent Office: 2,056 Days
• Field of Search: 600/583, 600/352, 600/347, 600/345, 600/573, 600/584, 435/7.1, 257/414, 436/180, 436/148, 436/169, 436/177, 422/504, 738/631.1, 738/631.2, 738/645.2, 738/646.1
• US Class Current: 600/584
• CPC Class Codes: A61B 2562/125 characterised by the manufacture of electrodes
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150396 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150427 Specific tip design, e.g. for improved penetration characteristics
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/150984 Microneedles or microblades
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/15119 comprising shape memory alloys
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/685 Microneedles

Abstract

In some aspects, an analyte sensor is provided for obtaining and detecting an analyte concentration level in a bio-fluid sample. The analyte sensor has a sensor body including a semiconductor material, an active region coupled to the sensor body, and a lancet provided on the analyte sensor. The conductor may include a fiber having a core of a conductive material and a semiconductor cladding surrounding the core. Numerous other aspects are provided.

Claims

1. An analyte sensor, comprising:

a cylindrical sensor body comprised of a semiconductor material;

an active region positioned within and coupled to the cylindrical sensor body, the active region configured to determine an analyte concentration level; and

a cleaved surface on a leading end of the cylindrical sensor body forming a lancet on the analyte sensor;

wherein at least a portion of the cylindrical sensor body is in contact with a fluid electrolyte.

2. The analyte sensor of claim 1, wherein the sensor body comprises a core of a conductive material and a cladding surrounding the core comprised of the semiconductor material.

3. The analyte sensor of claim 2, wherein the conductive material of the core comprises carbon and the semiconductor material of the cladding comprises silicon carbide.

4. The analyte sensor of claim 1, wherein the sensor body includes an end in electrical contact with the active region thereby forming at least a portion of a working electrode.

5. The analyte sensor of claim 1, wherein a cavity is located in the interior of the cylindrical sensor body, the active region being positioned within the cavity.

6. The analyte sensor of claim 1, wherein the lancet is formed on a cladding of the sensor body.

7. The analyte sensor of claim 6, further comprising a channel formed proximate the lancet adapted to direct a bio-fluid into the cavity.

8. The analyte sensor of claim 1, further comprising a reference electrode coupled to the analyte sensor.

9. The analyte sensor of claim 8, wherein the reference electrode is positioned in contact with a fluid electrolyte.

10. The analyte sensor of claim 9, further comprising a sealing material that surrounds at least a portion of the sensor body and that contains the fluid electrolyte.

11. The analyte sensor of claim 1, wherein the analyte sensor is further adapted to extend and retract within a port in a housing.

12. The analyte sensor of claim 1, further comprising an insulating layer surrounding the sensor body.

13. The analyte sensor of claim 1, wherein the lancet is formed on a separate lancet member coupled to the sensor body.

14. The analyte sensor of claim 1, further comprising a reference electrode at least partially surrounding a portion of the sensor body.

15. The analyte sensor of claim 1, wherein the analyte comprises one or more of glucose, lactate, aspartate, and glutamate.

16. The analyte sensor of claim 1, further comprising:

a core comprised of a conductive material;

a cladding comprised of the semiconductor material surrounding the core;

a cavity formed proximate to the core; and

the active region positioned within the cavity.

17. The analyte sensor of claim 1, further comprising:

a fiber comprised of the semiconductor material; and

the active region in contact with the fiber.

18. An analyte sensor comprising:

a cylindrical sensor body comprised of a semiconductor material;

an active region positioned within and coupled to the cylindrical sensor body, the active region configured to determine an analyte concentration level;

a cleaved surface on a leading end of the cylindrical sensor body forming a lancet on the analyte sensor; and

a reference electrode coupled to the analyte sensor;

wherein the reference electrode comprises a coil, foil, or film.

19. An analyte sensor comprising:

a cylindrical sensor body comprised of a semiconductor material;

an active region positioned within and coupled to the cylindrical sensor body, the active region configured to determine an analyte concentration level;

a cleaved surface on a leading end of the cylindrical sensor body forming a lancet on the analyte sensor; and

a cavity proximate to the active region and a reference electrode positioned within the cavity.

20. An analyte sensor comprising:

a cylindrical sensor body comprised of a semiconductor material;

an active region positioned within and coupled to the cylindrical sensor body, the active region configured to determine an analyte concentration level; and

a cleaved surface on a leading end of the cylindrical sensor body forming a lancet on the analyte sensor;

wherein a cavity is formed into a side wall of the cylindrical sensor body.

21. The analyte sensor of claim 20, wherein the cavity includes a pocket formed into a core of the cylindrical sensor body.