Analytical aid

• US 7,976,479 B2
• Filed: 09/22/2007
• Issued: 07/12/2011
• Est. Priority Date: 03/24/2005
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US11/859,753
• Publication Number:
  US 20080065131A1
• Time in Patent Office: 1,389 Days
• Field of Search: 600/583, 600/573, 606181-183, 606/171
• US Class Current: 600/584
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150435 Specific design of proximal end
• CPC Class Codes: A61B 5/150465 Specific design of proximal end
• 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 5/150557 Protectors removed by bending
• CPC Class Codes: A61B 5/150694 Procedure for removing protection means at the time of piercing
• CPC Class Codes: A61B 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable

Abstract

An analytical aid including a base, a lancet and a test element. The lancet includes a lancet point and a distal end of the lancet can be attached to the base. At least the lancet point is located in a recess in the base and the recess can be closed by a cover as long as the analytical aid is in an unused state. The base includes a predetermined breaking point or position, at which the base is broken into two segments when stress is applied. The predetermined breaking point is arranged such that the lancet point is exposed for use when the base breaks at the predetermined breaking point. A test element is attached to the base.

Claims

1. An analytical aid for analyzing a body fluid, comprising:

a base that is breakable into a first segment and a second segment to produce a broken edge when a bending force is applied to the base, the base having a recess;

a lancet connected to the base and having a lancet point that is located in the recess when the analytical aid is in an unused state, the lancet point becoming exposed for puncturing a body part when the base is broken into the first segment and the second segment;

a test element at which a body fluid is analyzed attached to the base; and

a cover that covers the lancet point when the analytical aid is in the unused state, wherein the lancet ruptures the cover when the base is broken and the analytical aid is moved from the unused state.

2. The analytical aid of claim 1, wherein the recess includes a slit running substantially along a longitudinal direction of the analytical aid.

3. The analytical aid of claim 1, wherein the lancet comprises a first portion that is connected to the base and a second portion that includes the lancet point, the first and second portions being angled relative to one another.

4. The analytical aid of claim 1, wherein at least one of the base and the cover comprises a material made brittle by irradiation.

5. The analytical aid of claim 1, wherein the lancet point ruptures the cover when the base is broken and the analytical aid is moved from the unused state.

6. The analytical aid of claim 1, wherein the base comprises a predetermined breaking position comprising at least one of a notch and a channel formed in the base.

7. The analytical aid of claim 1, wherein the test element includes an application area for applying a sample to be analyzed, the application area facing the base when the analytical aid is in the unused state.

8. The analytical aid of claim 1, further comprising a measuring head, wherein the test element is at least partially flexible and is stretchable over the measuring head during use of the analytical aid.

9. The analytical aid of claim 8, wherein the test element includes at least one loop detachably connected to the base, the loop unfolding when the base is broken and the analytical aid is moved from the unused state.

10. The analytical aid of claim 1, further comprising a bending device that applies the bending force to the base to break the base.

11. An analytical aid for analyzing a body fluid, comprising:

a base that is breakable during use into a first segment and a second segment;

a lancet connected to the base;

a test element attached to the base;

a measuring head configured to analyze an application area of the test element; and

the analytical aid being movable from an unused position to a use position, wherein;

in the unused position a point of the lancet is covered; and

during movement from the unused position to the use position the base is broken into the first and second segments and one of the segments moves relative to the other, the lancet point becomes exposed for puncturing a body part, and the test element is moved to a position in which the test element is stretched over the measuring head.

12. The analytical aid of claim 11, further comprising a cover that covers the lancet point when the analytical aid is positioned in the unused position, wherein the lancet point punctures the cover when the analytical aid is moved from the unused position to the use position.

13. The analytical aid of claim 12, wherein at least one of the base and the cover comprises a material made brittle by irradiation.

14. The analytical aid of claim 11, wherein the base comprises a recess in which at least a portion of the lancet is positioned when the analytical aid is in the unused position.

15. The analytical aid of claim 11, wherein, during movement of the analytical aid from the unused position to the use position, the first segment pivots relative to the second segment.

16. The analytical aid of claim 11, wherein, in the unused position the test element defines a loop, the loop unfolding during movement of the analytical aid from the unused position to the use position.

17. The analytical aid of claim 11, wherein in the unused position the application area of the test element faces the base and in the use position the application area is stretched over and faces away from the measuring head.

18. The analytical aid of claim 11, wherein the base comprises a predetermined breaking position which defines the first and second segments.

19. The analytical aid of claim 18, wherein a first portion of the test element is attached to the first segment and a second portion of the test element is attached to the second segment, the test element having a flexible portion between the first portion and second portion that is stretched over the measuring head when the analytical aid is moved to the use position.

20. An analytical aid for analyzing a body fluid, comprising:

a base that is breakable about a brittle breaking point into a first segment and a second segment when stress is applied to the base, the base having a recess;

a lancet connected to the base and having a lancet point that is located in the recess when the analytical aid is in an unused state, the lancet point becoming exposed for puncturing a body part when the base is broken into the first segment and the second segment;

a test element at which a body fluid is analyzed attached to the base; and

a cover that covers the lancet point when the analytical aid is in the unused state, wherein the lancet ruptures the cover when the base is broken and the analytical aid is moved from the unused state.

21. The analytical aid of claim 20, wherein the recess includes a slit running substantially along a longitudinal direction of the analytical aid.

22. The analytical aid of claim 20, wherein the lancet comprises a first portion that is connected to the base and a second portion that includes the lancet point, the first and second portions being angled relative to one another.

23. The analytical aid of claim 20, wherein at least one of the base and the cover comprises a material made brittle by irradiation.

24. The analytical aid of claim 20, wherein the lancet point ruptures the cover when the base is broken and the analytical aid is moved from the unused state.

25. The analytical aid of claim 20, wherein the base comprises a predetermined breaking position comprising at least one of a notch and a channel formed in the base.

26. The analytical aid of claim 20, wherein the test element includes an application area for applying a sample to be analyzed, the application area facing the base when the analytical aid is in the unused state.

27. The analytical aid of claim 20, further comprising a measuring head, wherein the test element is at least partially flexible and is stretchable over the measuring head during use of the analytical aid.

28. The analytical aid of claim 27, wherein the test element includes at least one loop detachably connected to the base, the loop unfolding when the base is broken and the analytical aid is moved from the unused state.

29. The analytical aid of claim 20, further comprising a bending device that applies a bending force to the base to break the base.