Analyte Sensors, Systems, Testing Apparatus and Manufacturing Methods

• US 20110180405A1
• Filed: 09/18/2009
• Published: 07/28/2011
• Est. Priority Date: 09/19/2008
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Bayer Healthcare LLC (Bayer AG)
• Inventors: Parasnis, Narasinha, Peteu, Serban, Chinnayelka, Swetha, Fei, Jiangfeng, Wang, Yuan
• Granted Patent: US 9,173,597 B2
• Time in Patent Office: Days
• US Class Current: 204/403.15
• CPC Class Codes: A61B 2562/08 Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/150007 Details
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150297 for piercing devices, i.e. devices ready to be used for lancing or piercing for piercing elements A61B5/150282, for driving devices A61B5/15029
• 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 5/150786 Optical identification systems, e.g. bar codes, colour codes
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15159 Piercing elements stocked in or on a disc
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 27/308 : at least partially made of carbon
• CPC Class Codes: G01N 27/3272 : Test elements therefor, i.e. disposable laminated substrates with electrodes, reagent and channels optical biosensors G01N33/52
• CPC Class Codes: G01N 27/3273 : Devices therefor, e.g. test element readers, circuitry details not specific to biochemical electrodes G01N33/4875
• CPC Class Codes: G01N 27/403 : Cells and electrode assemblies
• CPC Class Codes: Y10T 29/49002 : Electrical device making

Abstract

In some aspects, an analyte sensor is provided for detecting an analyte concentration level in a bio-fluid sample. The analyte sensor may include one or more conductors received in a hollow portion of a hollow member. The first conductor may be made, at least in part, of a semiconductor material and an active region may be provided in contact with at least the first conductor. The analyte sensor may, in one aspect, include a lancet and an integrated sensor. Manufacturing methods and apparatus and systems utilizing the analyte sensors are provided, as are numerous other aspects.

Claims

1. An analyte sensor, comprising:

a hollow member including a hollow portion;

a first conductor received in the hollow portion, the first conductor comprised of a semiconductor material; and

an active region in contact with at least the first conductor.

2. The analyte sensor of claim 1, further comprising a second conductor received in the hollow portion.

3. The analyte sensor of claim 2, further comprising a third conductor received in the hollow portion.

4. The analyte sensor of claim 3, wherein the third conductor comprises a fill detection electrode.

5. The analyte sensor of claim 1 further comprising a core of a conductive material and a cladding comprised of the semiconductor material.

6. The analyte sensor of claim 5, wherein the conductive material of the core of the first conductor comprises carbon and the semiconductor material of the cladding comprises silicon carbide.

7. The analyte sensor of claim 1, wherein the active region is included within a cavity formed, at least in part, by the walls of the hollow portion.

8. The analyte sensor of claim 1, further comprising a coded region.

9. The analyte sensor of claim 1, wherein the sensor is adapted to sense an analyte comprising one or more of glucose, lactate, aspartate, glutamate, and alcohol.

10. The analyte sensor of claim 1 further comprising a fill detector.

11. The analyte sensor of claim 1, wherein a second conductor surrounds the first conductor and is also received in the hollow portion.

12. The analyte sensor of claim 1, wherein the first conductor extends out of a second end of the hollow member from an end opposite from an end including a lancet point.

13. The analyte sensor of claim 1, wherein the hollow member comprises a hollow lancet including the hollow portion and a lancet point.

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

a cavity formed at least in part by walls of the hollow portion; and

wherein the active region is positioned within the cavity.

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

a lancet point formed on an end of the hollow member;

the first conductor secured in the hollow portion;

a cavity formed proximate to an end of the first conductor; and

wherein the active region is positioned within the cavity.

16. A testing apparatus, comprising:

a port receiving an analyte sensor, wherein the analyte sensor further comprises;

a hollow member including a hollow portion;

a first conductor received in the hollow portion, the first conductor comprised of a semiconductor material; and

an active region in contact with at least the first conductor.

17. An analyte sensor system, comprising:

a carriage having at least two guides;

an analyte sensor received in each of the at least two guides wherein the analyte sensor includes

a hollow member having a hollow portion and a lancet point, a first conductor received in the hollow portion, and an active region in contact with the first conductor.

18. An analyte sensor system, comprising:

a carriage having at least two guides;

a lancet received in at least one of the guides; and

an analyte sensor received in another of the guides.

19. The analyte sensor system of claim 18 wherein the analyte sensor comprises:

a sleeve including a hollow portion;

a first conductor comprised of a semiconductor material received in the hollow portion; and

an active region positioned in contact with at least the first conductor.

20. A method of manufacturing an analyte sensor, comprising the steps of:

providing a hollow member including a hollow portion; and

receiving and securing a first conductor in the hollow portion wherein the first conductor is comprised of a semiconductor material, and an active region is applied to the first conductor.