CALIBRATION MATERIAL DELIVERY DEVICES AND METHODS

• US 20110294152A1
• Filed: 11/30/2010
• Published: 12/01/2011
• Est. Priority Date: 11/30/2009
• Status: Active Grant

• Current Assignee: Intuity Medical, Inc.
• Original Assignee: Intuity Medical, Inc.
• Inventors: Tomasco, Michael F., Bowers, Robert W., Ly, Peter Uy-Vu, Reynolds, Paul D., Tansey, Kimberly J., Lipman, Kelley J., Larkin, John F., Chen, Jennifer Yuh-Jen, Escutia, Raúl, Gaffney, Robin S., Stewart, Christopher L.
• Granted Patent: US 8,919,605 B2
• Time in Patent Office: Days
• US Class Current: 435/29
• 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 Flexible; Elastomeric
• 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: 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: G16Z 99/00 : Subject matter not provided for in other main groups of this subclass
• CPC Class Codes: Y10T 436/10 : Composition for standardization, calibration, simulation, stabilization, preparation or preservation; processes of use in preparation for chemical testing
• CPC Class Codes: Y10T 436/107497 : Preparation composition [e.g., lysing or precipitation, etc.]

Abstract

A device is described that includes: a first portion configured to be grasped by the hand of the user, and a second portion defining a reservoir containing a control material, wherein the control material contains a target analyte in a known or predetermined concentration. Related arrangements and methods are also described.

Claims

1. A device comprising:

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

a second portion defining a reservoir containing a first control material, wherein the control material comprises a target analyte of a known or predetermined concentration.

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 second portion further comprises a body shaped and configured to mate with an opening disposed in an analyte monitor.

6. The device of claim 5, wherein the second portion further comprises a flange which is configured to limit the depth of insertion of the second portion into the analyte monitor.

7. The device of claim 6, further comprising a gasket arranged to abut the flange.

8. The device of claim 1, wherein the first portion is in the form of a flattened paddle-like shape.

9. The device of claim 8, wherein the first portion has a cross-section which is relatively thin at its middle, and relatively wider at its ends.

10. The device of claim 9, further comprising a slippage reducing feature.

11. The device of claim 10, wherein the slippage reducing feature comprises one or more ribs disposed on the first portion.

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

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

14. The device of claim 13, wherein the first and second portions are part of a one-piece monolithic structure.

15. The device of claim 1, wherein the second portion comprises a flexible neck, the flexible neck permitting relative movement between the first portion and the second portion of the device.

16. The device of claim 1, wherein the first portion comprises a first hollow interior, and the second portion comprises a second hollow interior, wherein the first hollow interior and the second hollow interior are in fluid communication with each other, and wherein the first hollow interior and second hollow interior are in fluid communication with the reservoir.

17. The device of claim 16, wherein the first hollow interior is collapsible, thereby forcing the control material out of the reservoir.

18. The device of claim 1, wherein the reservoir comprises a separable reservoir component.

19. The device of claim 18, wherein the second portion comprises a recess adapted to receive the separable reservoir component.

20. The device of claim 19, wherein the separable reservoir component is frictionally retained within the recess in a releasable manner.

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

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

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

24. The device of claim 23, wherein the first and second control materials are substantially the same.

25. The device of claim 23, wherein the first and second control materials are different.

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

27. The device of claim 26, 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.

28. The device of claim 27, wherein the marker comprises a dye.

29. The device of claim 26, wherein the marker is composed to produce a temporary color change indicative of the presence of the control material.

30. In combination, an integrated meter comprising a housing with an opening formed therein, and the device of any of claim 1, the second portion comprising a body and a flange shaped and configured to be received by the opening in the integrated meter.

31. The combination of claim 30, wherein device further comprises a frangible seal covering the reservoir, and the integrated meter further comprising a hollow piercing element constructed and arranged to pierce the seal and convey the control material toward a location within the meter for analysis.

45. The method of claim 40, wherein the control material is introduced to the single or multi-test cartridge using a device as defined in any of claims 1-19.

32. A method of conveying a control material to an analyte monitor, the method comprising:

(i) providing a dispenser comprising a first portion configured to be grasped by the hand of the user, and a second portion defining a reservoir having a frangible seal thereon, the reservoir containing a control material, wherein the control material comprises a target analyte in a known and/or predetermined concentration;

(ii) breaking the frangible seal; and

(iii) conveying the control material to a location for analysis by the analyte monitor.

33. The method of claim 32, wherein the second portion comprises a body shaped and configured to mate with the analyte monitor.

34. The method of claim 32, the method further comprises piercing the frangible seal, and conveying the control material to the location within the analyte monitor for analysis.

35. The method of claim 32, wherein the control material comprises a control liquid or solution.

36. The method of claim 32, wherein the control material comprises an absorbent material upon which the control liquid or solution is absorbed.

37. The method of claim 32, wherein the second portion further comprises a flange which is configured to limit the depth of insertion of the second portion into an opening disposed in the analyte monitor.

38. The method of claim 32, the method further comprising sensing the presence of the second portion of the dispenser.

39. The method of claim 32, the method further comprising distinguishing between the control material and a body fluid without intervention from the user.

40. A method of verifying the accuracy of the operation of an analyte monitoring device using a control material having a known and/or predetermined concentration of at least one analyte, the method comprising:

providing a single or multi-test cartridge having information associated therewith defining an acceptable range of measured analyte concentration values for the control material;

associating the single or multi-test cartridge with the device;

reading the information off the single or multi-test cartridge;

introducing a control material to the single or multi-test cartridge;

the device automatically determining the presence of a control material;

analyzing the control material to measure the concentration of analyte contained therein; and

comparing the measured concentration with the information to determine if the measured concentration corresponds to the acceptable range of concentration values obtained from the information.

41. The method of claim 40, wherein the at least one analyte comprises glucose.

42. The method of claim 40, wherein the cartridge comprises a multi-test cartridge.

43. The method of claim 40, wherein the information is contained in a bar code or RFID chip associated with a single or multi-test cartridge.

44. The method of claim 40, further comprising storing the information read off the single or multi-test cartridge in a memory of the device.

46. The method of claim 40, wherein the control material was analyzed using a colorimetric technique.

47. The method of claim 40, further comprising providing a pass or fail signal to indicate whether or not the measured concentration falls within the acceptable range of concentration values.