Calibration material delivery devices and methods

• US 8,919,605 B2
• Filed: 11/30/2010
• Issued: 12/30/2014
• Est. Priority Date: 11/30/2009
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Sponsoring Entity: Intuity Medical, Inc.
• Inventors: Lipman, Kelley J., Tomasco, Michael F., Ly, Peter Uy-Vu, Chen, Jennifer Yuh-Jen, Reynolds, Paul D., Larkin, John F., Gaffney, Robin S., Tansey, Kimberly J., Stewart, Christopher L., Escutia, Ral, Bowers, Robert W.
• Primary Examiner(s): Hicks, Robert J
• APPLICATION: US 20110294152A1
• Time in USPTO: 1491 Days
• Field of Search: 220/755, 220/759, 220/756, 220/752, 164/25, 164/22, 164/30, 600/309, 600/316, 206/569, 206/571, 435/29, 435/4
• US Class Current: 220/756
• CPC Class Codes: A61B 2560/0223 : of calibration, e.g. protocols for calibrating sensors
• CPC Class Codes: A61B 2562/08 : Sensors provided with means for identification, e.g. barcodes or memory chips
• CPC Class Codes: A61B 5/14532 : for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1495 : Calibrating or testing of in-vivo probes
• CPC Class Codes: B01L 2200/148 : Specific details about calibrations
• CPC Class Codes: B01L 2300/022 : Transponder chips
• CPC Class Codes: B01L 2300/123 : FlexibleElastomeric
• CPC Class Codes: B01L 2400/0481 : squeezing of channels or chambers
• CPC Class Codes: B01L 2400/0683 : mechanically breaking a wall or membrane within a channel or chamber
• CPC Class Codes: B01L 3/523 : with means for closing or opening
• CPC Class Codes: G01N 21/78 : producing a change of colour
• CPC Class Codes: G01N 2201/12707 : Pre-test of apparatus, e.g. dark test, sensor test
• CPC Class Codes: G01N 2496/80 : Multi-analyte reference solutions containing cholesterol, glucose and the like
• 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 27/3274 : Corrective measures, e.g. error detection, compensation for temperature or hematocrit, calibration coding of calibration information G01N33/48771
• CPC Class Codes: G01N 33/48785 : Electrical and electronic details of measuring devices for physical analysis of liquid biological material not specific to a particular test method, e.g. user interface or power supply
• CPC Class Codes: G01N 33/66 : involving blood sugars, e.g. galactose
• CPC Class Codes: G01N 33/96 : involving blood or serum control standard
• CPC Class Codes: G06F 19/00 : Digital computing or data processing equipment or methods, specially adapted for specific applications specially adapted for specific functions G06F17/00; data processing systems or methods specially adapted for administrative, commercial, financial, managerial, supervisory or forecasting purposes G06Q; healthcare informatics G16H
• CPC Class Codes: G16H 10/40 : for data related to laboratory analysis, e.g. patient specimen analysis
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y10T 436/10 : Composition for standardization, calibration, simulation, stabilization, preparation or preservationprocesses of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/107497 : Preparation composition [e.g., lysing or precipitation, etc.]

Abstract

These are devices and methods of delivering calibration or control information to a device, such as an analyte monitor. The devices may include a first portion configured to be grasped by the hand of the user, and a second portion including a reservoir and a flexible neck. The reservoir may contain a control material that contains a target analyte in a known or predetermined concentration.

Claims

1. A device comprising:

a first portion configured to be grasped by a hand of a user; and

a second portion comprising;

a reservoir containing a first control material, wherein the control material comprises a target analyte of a known or a predetermined concentration; and

a flexible neck configured to permit relative movement between the first portion and the reservoir, wherein the flexible neck comprises a first narrow neck region, a second narrow neck region, and an enlarged neck region between the first and second narrow neck regions.

2. The device of claim 1, further comprising a frangible seal which contains the control material within the reservoir, and shields the control material from exposure to the environment.

3. The device of claim 1, wherein the control material comprises a control liquid or solution.

4. The device of claim 3, wherein the control material comprises an absorbent material upon which the control liquid or solution is absorbed.

5. The device of claim 1, wherein the first portion is in the form of a flattened shape.

6. The device of claim 5, wherein the first portion has a cross-section which is relatively thin at its middle, and relatively wider at its ends.

7. The device of claim 6, further comprising a slippage reducing feature.

8. The device of claim 7, wherein the slippage reducing feature comprises one or more ribs disposed on the first portion.

9. The device of claim 1, wherein the first portion and the second portion are formed as separate components which are joined together.

10. The device of claim 1, wherein the first and second portions are integrally formed.

11. The device of claim 10, wherein the first and second portions are part of a one-piece monolithic structure.

12. The device of claim 2, wherein the frangible seal comprises a pierceable foil.

13. The device of claim 2, wherein the frangible seal comprises a hinge and a cap portion configured to mate with and seal the reservoir.

14. The device of claim 1, further comprising a third portion defining a reservoir containing a second control material.

15. The device of claim 14, wherein the first and second control materials are substantially the same.

16. The device of claim 14, wherein the first and second control materials are different.

17. The device of claim 1, wherein the control material further comprises at least one marker indicative of the presence of the control material.

18. The device of claim 17, wherein the marker is composed to produce a color change possessing a degree of magnitude such that it is indicative of the presence of the control material.

19. The device of claim 18, wherein the marker comprises a dye.

20. The device of claim 17, wherein the marker is composed to produce a temporary color change indicative of the presence of the control material.