Integrated Lancet and Blood Glucose Meter System

• US 20080021291A1
• Filed: 07/30/2007
• Published: 01/24/2008
• Est. Priority Date: 07/27/2004
• Status: Active Grant

• Current Assignee: Abbott Diabetes Care Incorporated (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Laboratories Incorporated
• Inventors: Zocchi, Michael
• Granted Patent: US 8,257,258 B2
• Time in Patent Office: Days
• US Class Current: 600/300
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• CPC Class Codes: A61B 5/150213 Venting means
• CPC Class Codes: A61B 5/150358 Strips for collecting blood, e.g. absorbent optical reagent test strips G01N21/8483; chemical reagent test strips G01N33/4875, G01N33/52
• CPC Class Codes: A61B 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 33/4875 Details of handling test elements, e.g. dispensing or storage, not specific to a particular test method test-elements per se B01L, automatic analysers G01N35/00, in-vivo analysis on the human body for medical diagnosis A61B

Abstract

A sensor array designed to be continuously indexed through a compatible blood glucose test monitor for the purpose of conducting multiple consecutive blood glucose measurements. The sensor array can be configured to substantially conform to a non-planar surface. In one embodiment, the sensor array includes first and second test sensors which are hingedly coupled together through a pin and socket interconnection. In another embodiment, the sensor array includes a unitary, non-conductive substrate which is scored to define one or more fold lines, a first set electrodes deposited on the substrate to define a first test sensor, and a second set of electrodes deposited on the substrate to define a second test sensor. In another embodiment, the sensor array includes a first test sensor, a second test sensor spaced apart from said first test sensor, a first spacer mounted on the first test sensor, a second spacer mounted on the second test sensor, and a unitary flexible member disposed across said first and second spacers.

Claims

1. A blood glucose meter adapted to receive a disposable lancet and a plurality of sensors for effectively combining both lancing and measurement processes into a single device, comprising:

(a) a housing having an opening defined therein against which a user is to position a penetration location of his/her skin;

(b) a disposable lancet within the housing;

(c) a lancet holder for mounting the lancet and driving the lancing through the opening to penetrate the skin of the user at the penetration location;

(d) a plurality of sensors mounted within the housing and disposed along a feed track;

(e) mechanical linkages within meter for automatically indexing the sensors along the feed track; and

(f) a power source and electrodes for providing a electrical energy for performing an assay of body fluid drawn from the penetration location and applied to a sensor.

2. The blood glucose meter of claim 1, further comprising a display for showing test results.

3. The blood glucose meter of claim 1, wherein the plurality of sensors comprises

(a) a first test sensor, and

(b) a second test sensor hingedly coupled to said first test sensor.

4. The blood glucose meter of claim 1, wherein the plurality of test sensors comprises

(a) a first test sensor,

(b) a second test sensor spaced apart from said first test sensor, and

(c) a unitary member coupled to said first and second test sensors.

5. The blood glucose meter of claim 1, wherein the plurality of test sensors comprises

(a) a first test sensor, and

(b) a second test sensor separate from said first test sensor,

(c) wherein said first test sensor is sized and shaped to interlock with said second test sensor.

6. The blood glucose meter of claim 5, wherein each of said first and second test sensors comprises:

(a) a unitary, non-conductive substrate, said substrate including a top surface and a bottom surface,

(b) a first set of electrodes deposited on the top surface of said substrate, and

(c) a cover affixed to said substrate over said first set of electrodes.

7. The blood glucose meter of claim 5, wherein each of the test sensors comprise:

(a) a unitary, non-conductive substrate, said substrate including a top surface and a bottom surface, and

(b) a plurality of electrodes deposited on the top surface of said substrate in a spaced apart configuration and defining a reactive area.

8. A diabetes care article, comprising:

(a) a plurality of sensors mounted within a housing and disposed along a feed track for indexing the sensors in defined increments for performing multiple tests without requiring a user to undertake one or more preparatory steps including unwrapping, loading, unloading or discarding individual test sensors, or combinations thereof; and

(b) one or more mechanical linkages within housing for automatically indexing the sensors along the feed track.

9. The article of claim 8, wherein a disposable lancet and lancet holder are also contained within the housing, the lancet holder for mounting the lancet and driving the lancet through the opening to penetrate the skin of the user at a penetration location.

10. The article of claim 8, wherein a power source and electrodes are also contained within the housing for providing electrical energy for performing an assay of body fluid drawn from the penetration location and applied to a sensor.

11. The article of claim 8, further comprising a display outside the housing for showing test results.

12. The blood glucose meter of claim 8, wherein the plurality of sensors comprises

(a) a first test sensor, and

(b) a second test sensor hingedly coupled to said first test sensor.

13. The blood glucose meter of claim 8, wherein the plurality of test sensors comprises

(a) a first test sensor,

(b) a second test sensor spaced apart from said first test sensor, and

(c) a unitary member coupled to said first and second test sensors.

14. The blood glucose meter of claim 8, wherein the plurality of test sensors comprises

(a) a first test sensor, and

(b) a second test sensor separate from said first test sensor,

(c) wherein said first test sensor is sized and shaped to interlock with said second test sensor.

15. The blood glucose meter of claim 14, wherein each of said first and second test sensors comprises:

(a) a unitary, non-conductive substrate, said substrate including a top surface and a bottom surface,

(b) a first set of electrodes deposited on the top surface of said substrate, and

(c) a cover affixed to said substrate over said first set of electrodes.

16. The blood glucose meter of claim 14, wherein each of the test sensors comprise:

(a) a unitary, non-conductive substrate, said substrate including a top surface and a bottom surface, and

(b) a plurality of electrodes deposited on the top surface of said substrate in a spaced apart configuration and defining a reactive area.

17. A method of operating a blood glucose meter which is adapted to receive a disposable lancet and a plurality of sensors, comprising:

(a) providing a meter including a housing having an opening defined therein;

(b) mounting a plurality of sensors within the housing along a feed track;

(c) mounting a lancet to a lancet holder within the housing;

(d) receiving a penetration location of the skin of a user at the opening;

(e) driving a lancet mounted to a lancet holder through the opening and thereby penetrating the skin of the user at the penetration location;

(f) automatically indexing the sensors along the feed track;

(g) applying body fluid drawn from the penetration location to a sensor;

(h) applying electrical power to electrodes for performing an assay of the body fluid; and

(i) displaying the test results.

18. The method of claim 17, wherein the automatic indexing of the sensors includes indexing in defined increments for performing multiple tests without requiring a user to undertake one or more preparatory steps including unwrapping, loading, unloading or discarding individual test sensors, or combinations thereof.

19. The method of claim 17, wherein the automatic indexing of the sensors along the feed track is facilitated by one or more mechanical linkages between sensors.

20. The method of claim 17, wherein the plurality of test sensors comprises

(a) a first test sensor, and

(b) a second test sensor separate from said first test sensor,

(c) wherein said first test sensor is sized and shaped to interlock with said second test sensor, and the mounting of the plurality of sensors includes providing said sensors in an interlocked configuration.