Hand-held analysis device

• US 7,964,147 B2
• Filed: 06/23/2006
• Issued: 06/21/2011
• Est. Priority Date: 12/24/2003
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Schulat, Jochen, Müller, Josef, Rasch-Menges, Jürgen, Scherer, Jörg, Jansen, Paul
• Primary Examiner(s): SIEFKE, SAMUEL P
• Application Number:
  US11/474,861
• Publication Number:
  US 20070009381A1
• Time in Patent Office: 1,824 Days
• Field of Search: 422/50, 422/68.1, 422/82.05, 422/99, 422/400, 422/401, 422/403, 422/410
• US Class Current: 422/82.05
• CPC Class Codes: G01N 33/48757 Test elements dispensed from a stack

Abstract

The invention relates to a hand-held analytical device for analyzing a sample, in particular a biological fluid, for a medically significant component, comprising a housing comprising a loading opening for receiving a replaceable cartridge having multiple chambers that may contain analytical consumables, in particular test strips, and each chamber comprising an opening on at least one face of the cartridge and each opening may be sealed by a sealing foil, a removal facility for removing one of the analytical consumables from the cartridge. The removal facility can be used to remove one of the consumables from one of the chambers of the cartridge, in the process of which the opening sealed by the sealing foil is opened. A drive allows the cartridge to be moved in order to position one chamber in a removal position in which a consumable can be removed from the chamber by the removal facility. The invention provides for the hand-held analytical device to comprise a testing facility that can generate a signal containing information regarding whether the opening of one of the chambers is sealed by sealing foil.

Claims

1. A hand-held analytical device for analyzing a sample for a medically significant component, comprising:

an analysis unit;

a display;

a housing comprising a loading opening for receiving a replaceable cartridge that includes multiple chambers configured to contain analytical consumables, at least one chamber comprising an opening which is initially sealed by a sealing foil;

a drive configured to move the cartridge to position one of the chambers in a removal position;

a removal facility configured for removing the analytical consumable from the chamber residing in the removal position, during which the sealing foil sealing the chamber residing in the removal position is opened; and

a testing facility configured to generate a signal indicating whether the opening of one of the chambers is sealed by the sealing foil, the testing facility being connected to the analysis unit for analyzing the signal.

2. The hand-held analytical device of claim 1, wherein the testing facility is configured to test the sealing foil of the chamber residing in the removal position.

3. The hand-held analytical device of claim 1, wherein the analysis unit comprises a memory which stores information regarding whether one or more of the openings of the chambers are sealed.

4. The hand-held analytical device of claim 1, wherein the analysis unit is connected to the removal facility such that the removal facility can be actuated only if the opening of the chamber residing in the removal position that is tested by the testing facility is sealed by the sealing foil.

5. The hand-held analytical device of claim 1, wherein the analysis unit comprises a control unit for controlling the drive, whereby the analysis unit actuates the drive when the opening of the chamber residing in the removal position is not sealed by the sealing foil.

6. The hand-held analytical device of claim 1, wherein the replaceable cartridge is a drum cartridge, and, upon a rotation of the cartridge by 360°

, the testing facility and the analysis unit can determine how many or which of the chambers are sealed by the sealing foil.

7. The hand-held analytical device of claim 6, further comprising a switch, the actuation of which causes the analysis unit to determine how many or which of the chambers are sealed by the sealing foil.

8. The hand-held analytical device of claim 1, wherein the analysis unit is connected to the display and the display displays information obtained by the analysis unit regarding the sealing of one or more chambers of the cartridge.

9. The hand-held analytical device of claim 8, wherein the display is configured to display how many or which of the chambers are sealed by sealing foil.

10. The hand-held analytical device of claim 1, wherein the testing facility comprises a light source and an optical detector.

11. The hand-held analytical device of claim 10, wherein the optical detector and the light source are arranged on a common plate.

12. The hand-held analytical device of claim 10, wherein the testing facility comprises an optical system for guiding light of the light source onto one of the openings or for focusing light reflected by the sealing foil onto the detector.

13. The hand-held analytical device of claim 12, wherein the optical system comprises a first lens for guiding light of the light source onto one of the openings and a second lens for focusing the light reflected by the sealing foil onto the detector.

14. The hand-held analytical device of claim 13, wherein the testing facility comprises an injection molded part in which the first and second lenses are provided.

15. The hand-held analytical device of claim 1, wherein the detector comprises a phototransistor.

16. The hand-held analytical device of claim 1, wherein the testing facility comprises a light source for illuminating one of the openings of the cartridge.

17. The hand-held analytical device of claim 16, wherein the light source comprises an LED.

18. The hand-held analytical device of claim 1, wherein the sealing foil comprises a glossy metallic surface.

19. The hand-held analytical device of claim 1, further comprising position recognition means for determining whether one of the chambers is positioned in the removal position, wherein the testing facility can be actuated by the position recognition means.

20. A hand-held analytical device for analyzing a sample for a medically significant component, comprising:

a housing having a receptacle for removably receiving a cartridge having multiple chambers containing analytical consumables, at least one chamber comprising an opening that is initially sealed by a sealing foil, the sealing foil being opened during removal of the analytical consumable;

a light source and a detector disposed in the housing, the light source configured to illuminate an area of one of the openings of a cartridge positioned in the receptacle and the detector configured to detect light reflected from the area illuminated; and

an analysis unit disposed in the housing and configured to analyze the light detected by the detector to determine whether the one opening being tested is sealed by the sealing foil.

21. The hand-held device of claim 20, wherein the analysis unit comprises a memory which stores information regarding whether one or more of the openings of the chambers are sealed.

22. The hand-held analytical device of claim 20, comprising a removal facility in communication with the analysis unit, the removal facility configured to remove the analytical consumable from a chamber of the cartridge that is positioned in a removal position, wherein the removal facility can be actuated only if the opening of the chamber residing in the removal position is determined to be sealed by the analysis unit.

23. The hand-held analytical device of claim 20, further comprising a switch, the actuation of which causes the analysis unit to determine how many or which of the chambers of a cartridge positioned in the receptacle are sealed.

24. The hand-held analytical device of claim 20, further comprising a display configured to display how many or which of the chambers are sealed by the sealing foil.

25. The hand-held analytical device of claim 20, wherein the detector and the light source are arranged on a common plate.

26. The hand-held analytical device of claim 20, further comprising a first lens for guiding light from the light source and a second lens for focusing light onto the detector.

27. The hand-held analytical device of claim 20, wherein the detector comprises a phototransistor.

28. The hand-held analytical device of claim 20, wherein the light source comprises an LED.

29. The hand-held analytical device of claim 20, further comprising an analytical facility.

30. A system for analyzing a medically significant component of a body fluid, comprising:

a cartridge, comprising;

multiple chambers containing analytical consumables, comprising at least one chamber comprising an opening; and

a sealing foil connected to the cartridge which initially seals one or more of the openings, the sealing foil being opened during removal of the analytical consumable; and

a hand-held analytical instrument, comprising;

a receptacle that removably receives the cartridge;

a light source configured to illuminate an area of the cartridge at which one of the openings is located;

a detector for detecting light reflected from the area illuminated; and

an analysis unit for analyzing the light detected by the detector and determining therefrom whether the opening being tested is sealed by the sealing foil.

31. The system of claim 30, wherein the detector comprises a phototransistor.

32. The system of claim 30, wherein the light source comprises an LED.

33. The system of claim 30, wherein the hand-held instrument comprises a display configured to display information concerning whether the opening being tested is sealed.

34. The system of claim 30, wherein the hand-held instrument further comprises a removal facility for removing the consumables from the cartridge, the removal facility being communicably connected to the analysis unit, wherein the analysis unit is configured to prevent actuation of the removal facility for any chamber of the replaceable cartridge whose opening has been determined by the analysis unit to be unsealed.

35. The system of claim 34, wherein the sealing foil comprises a glossy metallic surface.

36. The system of claim 30, wherein the hand-held instrument comprises an analytical facility wherein the analytical consumables are analyzable by the analytical facility.