Analyte sensors, systems, testing apparatus and manufacturing methods

• US 10,022,080 B2
• Filed: 10/09/2015
• Issued: 07/17/2018
• Est. Priority Date: 09/19/2008
• Status: Active Grant

• Current Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Original Assignee: Ascensia Diabetes Care Holdings AG (PHC Holdings Corporation)
• Inventors: Chinnayelka, Swetha, Fei, Jiangfeng, Parasnis, Narasinha, Peteu, Serban, Wang, Yuan
• Primary Examiner(s): NOGUEROLA, ALEXANDER STEPHAN
• Application Number:
  US14/879,817
• Publication Number:
  US 20160029935A1
• Time in Patent Office: 1,012 Days
• 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 system, comprising:

a carriage having at least two guides;

at least two analyte sensors each respectively received in one of the at least two guides wherein each analyte sensor includes

a member defining a hollow portion,

a sleeve secured in the hollow portion,

a first conductor secured in the sleeve,

a second conductor secured in the sleeve, and

an active region coupled to the first conductor and extending beyond the sleeve.

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

3. The analyte sensor system of claim 2, wherein the third conductor includes a fill detection electrode.

4. The analyte sensor system of claim 1, wherein the active region is within the hollow portion formed, at least in part, by the member and proximate to a first end of the member.

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

6. The analyte sensor system of claim 1, wherein the sensors are each independently adapted to sense an analyte comprising one or more of glucose, lactate, aspartate, glutamate, and alcohol.

7. The analyte sensor system of claim 1, wherein the members of each sensor include a first end and an opposing second end, the first end of each member including a lancet point, and wherein the first conductors extend out of the second end of the members.

8. The analyte sensor system of claim 1, wherein the members each include a hollow lancet including the hollow portion and a lancet point at an end thereof.

9. The analyte sensor system of claim 1, wherein the sensors each further include a cavity defined by an inner wall of the member, an end of the member, and an end of the sleeve secured therein;

and wherein the active region is positioned within the cavity.

10. The analyte sensor system of claim 1, wherein the sensors each further include:

a lancet point formed on an end of the member;

a cavity formed within the hollow portion, proximate to an end of the 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.

14. The analyte sensor system of claim 1, wherein the second conductor surrounds the first conductor.

11. An analyte sensor system, comprising:

a carriage having at least two guides;

at least two analyte sensors each respectively received in one of the at least two guides wherein each analyte sensor includes

a member defining a hollow portion,

a sleeve secured in the hollow portion,

a first conductor secured in the sleeve, and

an active region coupled to the first conductor and extending beyond the sleeve, wherein;

the first conductor includes a core of a conductive material and a cladding of a semiconductor material.

12. The analyte sensor system of claim 11, wherein the conductive material of the core includes carbon and the semiconductor material of the cladding includes silicon carbide.

13. An analyte sensor system, comprising:

a carriage having at least two guides;

at least two analyte sensors each respectively received in one of the at least two guides wherein each analyte sensor includes

a member defining a hollow portion,

a sleeve secured in the hollow portion,

a first conductor secured in the sleeve,

an active region coupled to the first conductor and extending beyond the sleeve, and

a fill detector.

15. An analyte sensor system, comprising:

a carriage having at least two parallel guides;

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

an analyte sensor received in another of the guides;

wherein the analyte sensor comprises;

a member defining a hollow portion,

a sleeve secured in the hollow portion,

a first conductor secured in the sleeve, and

an active region coupled to the first conductor and extending beyond the sleeve.

16. An analyte sensor system, comprising:

a carriage having at least two parallel guides;

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

an analyte sensor received in another of the guides;

wherein the carriage is adapted to rotate the guide including the analyte sensor to a position previously occupied by the guide including the lancet.

17. An analyte sensor system, comprising:

a carriage having at least two parallel guides;

a lancet received in at least one of the guides;

an analyte sensor received in another of the guides; and

an actuator adapted to extend the lancet and the analyte sensor.

18. An analyte sensor system, comprising:

a carriage having a plurality of parallel guides;

an integrated lancet and sensor received in each of the guides; and

an actuator operable to extend the integrated lancet and sensor in a single actuation to concurrently lance and sense analyte concentration,

wherein the integrated lancet and sensor comprises;

a member defining a hollow portion and a lancet point,

a sleeve secured in the hollow portion,

a first conductor secured in the sleeve, and

an active region coupled to the first conductor and extending beyond the sleeve.