Analytical aid

• US 8,007,445 B2
• Filed: 04/24/2006
• Issued: 08/30/2011
• Est. Priority Date: 04/22/2005
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Harttig, Herbert
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): NGUYEN, HUONG Q
• Application Number:
  US11/409,821
• Publication Number:
  US 20060247555A1
• Time in Patent Office: 1,954 Days
• Field of Search: 600/573, 600/576, 600583-584, 606181-183
• US Class Current: 600/583
• 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 5/150412 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 5/150557 Protectors removed by bending
• CPC Class Codes: A61B 5/150618 Integrally moulded protectors, e.g. protectors simultaneously moulded together with a further component, e.g. a hub, of the piercing element
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/150809 by audible feedback
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• 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 5/7207 of noise induced by motion artifacts

Abstract

The present invention relates to an analytical aid comprising a base body, a lancet and a test element. The base body comprises two subsidiary bodies hingedly connected to one another, the first subsidiary body carrying the lancet with lancet tip, and the second subsidiary body carrying the test element with test field and a sample application site. In an unused position of the analytical aid, the subsidiary bodies are arranged substantially in a common plane and the lancet is protected by a seal connected to the first subsidiary body and is separated from the test field of the test element. The two subsidiary bodies are pivotable relative to one another out of the common plane and the seal is openable so that the lancet tip is released for use.

Claims

1. An analytical aid for puncturing a body part and analyzing a body fluid sample, comprising:

first and second bodies hingedly connected to one another, the first body carrying a lancet having a lancet tip and the second body carrying a test element having a test field and a sample application site;

the analytical aid having an unused position in which the first and second bodies are arranged substantially in a common plane and in which the lancet is protected by a seal connected to the first body and is separated from the test field;

the first and second bodies being pivotable relative to one another from the unused position; and

wherein, pivoting the first and second bodies from the unused position causes the seal to open to release the lancet tip for use.

2. The analytical aid of claim 1, further comprising a flexible strip that hingedly connects the first body and the second body.

3. The analytical aid of claim 1, wherein the sample application site is positioned on the second body remote from the position of the connection of the first body and the second body.

4. The analytical aid of claim 1, wherein the lancet tip protrudes beyond the first body in the position of the connection of the first body and the second body.

5. The analytical aid of claim 1, wherein the lancet tip is oriented substantially parallel to the second body in the unused position of the analytical aid.

6. The analytical aid of claim 1, wherein the seal comprises a pocket which at least partially encloses the lancet when the analytical aid is in the unused position.

7. The analytical aid of claim 1, wherein the seal at the lancet tip is fixedly connected to the second body.

8. The analytical aid of claim 1, wherein the first body and the second body are hingedly connected by the seal.

9. The analytical aid of claim 1, wherein the test element comprises means for electrochemical or optical analysis of a sample present on the test field.

10. The analytical aid of claim 1, wherein the first body has a recess configured to engage a guide element of an analysis device.

11. The analytical aid of claim 1, further comprising a cover fixedly connected to the first body and releasably and reconnectably connected to the second body via an adhesion zone.

12. The analytical aid of claim 1, further comprising a means for capillary transport of a fluid sample from the sample application site to the test field.

13. The analytical aid of claim 1, further comprising a magazine which houses the analytical aid.

14. The analytical aid of claim 1, wherein the seal is connected to the second body in the unused position.

15. The analytical aid of claim 1, wherein the first and second bodies are pivotable relative to one another from the unused position to a second position in which the lancet is configured to puncture a body part.

16. An analytical aid for puncturing a body part and analyzing a body fluid sample, comprising:

first and second bodies hingedly connected to one another, the first body carrying a lancet having a lancet tip and the second body carrying a test element having a test field and a sample application site;

the analytical aid having an unused position in which the first and second bodies are arranged substantially in a common plane and in which the lancet is protected by a seal connected to the first and second bodies and is separated from the test field;

the first and second bodies being pivotable relative to one another from the unused position; and

the seal opening to release the lancet tip during pivoting of the first and second bodies relative to one another.

17. The analytical element of claim 16, wherein pivoting the first and second bodies causes the seal to open.

18. The analytical aid of claim 16, wherein the sample application site is positioned on the second body remote from the position of the connection of the first body and the second body.

19. The analytical aid of claim 16, wherein the lancet tip protrudes beyond the first body in the position of the connection of the first body and the second body.

20. The analytical aid of claim 16, wherein the lancet tip is oriented substantially parallel to the second body in the unused position of the analytical aid.

21. The analytical aid of claim 16, wherein the seal comprises a pocket which at least partially encloses the lancet when the analytical aid is in the unused position.

22. The analytical aid of claim 16, wherein the first body and the second body are hingedly connected by the seal.

23. The analytical aid of claim 16, wherein the first body has a recess configured to engage a guide element of an analysis device.

24. The analytical aid of claim 16, further comprising a cover fixedly connected to the first body and releasably and reconnectably connected to the second body via an adhesion zone.

25. The analytical aid of claim 16, wherein the first and second bodies are pivotable relative to one another from the unused position to a second position in which the lancet is configured to puncture a body part.