Analyte sensors, systems, testing apparatus and manufacturing methods

• US 9,173,597 B2
• Filed: 09/18/2009
• Issued: 11/03/2015
• 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: Chinnayelka, Swetha, Fei, Jiangfeng, Parasnis, Narasinha, Peteu, Serban, Wang, Yuan
• Primary Examiner(s): DINH, BACH T
• Application Number:
  US13/119,222
• Publication Number:
  US 20110180405A1
• Time in Patent Office: 2,237 Days
• Field of Search: 20440301-40315, 205/781, 2057835-785, 205/787
• US Class Current: 1/1
• 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 cylindrical member including an inner wall defining a hollow portion;

a hollow sleeve secured in the hollow portion;

a first conductor secured in the hollow sleeve, the first conductor comprised of a semiconductor material; and

an active region in contact with and electrically coupled to an end of the first conductor that extends beyond an end of the hollow sleeve.

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

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

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

5. The analyte sensor of claim 1, wherein the first conductor comprises 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 inner wall of the hollow cylindrical member, proximate to a first end of the hollow cylindrical member.

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, further comprising a second conductor secured in the hollow sleeve and surrounding the first conductor.

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

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

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

a cavity defined by the inner wall of the hollow cylindrical member, an end of the hollow cylindrical member, and an end of the hollow sleeve secured therein; 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 cylindrical member;

a cavity formed within the hollow portion, proximate to an end of the hollow sleeve secured in the hollow portion and 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 comprises;

a hollow cylindrical member including a hollow portion;

a hollow sleeve secured in the hollow portion;

a first conductor secured in the hollow sleeve, the first conductor comprised of a semiconductor material;

an active region in contact with and electrically coupled to an end of the first conductor that extends beyond an end of the hollow sleeve.

17. The method of manufacturing an analyte sensor, comprising:

providing a first conductor comprised of a semiconductor material;

applying and electrically coupling an active region to an end of the first conductor;

receiving and securing the first conductor in a hollow sleeve, wherein the end of the first conductor extends beyond an end of the hollow sleeve; and

receiving and securing the hollow sleeve in the hollow cylindrical member.

18. An analyte sensor, comprising:

a hollow cylindrical member including a first end and a second end and an inner wall defining a hollow portion extending between the first end and the second end,

the first end of the hollow cylindrical member defining an opening and including a lancet point formed thereon;

a hollow sleeve having a first end secured in the hollow portion proximate the first end of the hollow cylindrical member;

a first conductor and a second conductor secured in the hollow sleeve are electrically insulated from each other, each of the first and second conductors comprising a semiconductor fiber having;

a first end extending beyond the first end of the hollow sleeve proximate the first end of the hollow cylindrical member; and

a second end extending out of the second end of the hollow cylindrical member;

an active region in contact with and electrically coupled to the first ends of the semiconductor fibers of the first and second conductors;

wherein at least one of the second ends of the semiconductor fibers of the first and second conductors includes a coded region.