Analytical device with integrated lancet

• US 20020052618A1
• Filed: 10/31/2001
• Published: 05/02/2002
• Est. Priority Date: 10/31/2000
• Status: Abandoned Application

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: List, Hans, Haar, Hans-Peter
• Application Number:
  US09/999,683
• Publication Number:
  US 20020052618A1
• Time in Patent Office: Days
• US Class Current: 606/181
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/15029 for driving devices, i.e. means for driving the piercing element
• 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 5/15107 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads 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 5/15155 Piercing elements which are specially shaped or are provided with fittings or attachments to facilitate nesting, stacking or joining together end-to-end or side-by-side
• CPC Class Codes: A61B 5/15174 Piercing elements stocked in the form of a stack or pile

Abstract

The invention describes an analytical device (1) which is suitable for collecting and examining body fluids and in particular blood. The analytical device (1) contains a test element (2) and a lancet (3) whereby the test element (2) contains the following components: 1.) a frame element (7), and 2.) at least one detection element (6) which can also be multilayered and can contain among others an erythrocyte separation layer, a spreading layer and an optical barrier layer which is directly or indirectly connected to the frame element (7) and the lancet (3) contains the following components: 1.) a needle (11) with a tip (23) and 2.) a lancet body (10) which at least partially surrounds the needle (11). The inventive device (1) is characterized in that the lancet body (10) is movably connected to the frame element (7) of the test element (2) i.e. it can be folded or swung out such that the lancet (3) can adopt a storage position and a lancing position, the needle (11) being aligned in the storage position essentially parallel to the plane of the test element (2) and aligned in the lancing position essentially orthogonal to the plane of the test element (2).

Claims

1. An analytical device for collecting and examining a body fluid comprising:

a test element including a frame element defining a plane and a detection element connected to the frame element, and a lancet including a needle having a tip and a lancet body at least partially surrounding the needle, the lancet body being movably connected to the frame element such that the lancet can adopt a storage position wherein the needle is aligned essentially parallel to the plane of the test element and a lancing position wherein the needle is aligned essentially orthogonal to the plane of the test element.

2. The analytical device as claimed in claim 1, wherein the test element contains a separate zone of absorbent material, which is suitable for taking up excess sample liquid, in the immediate vicinity of the detection element.

3. The analytical device as claimed in claim 2, further comprising a common support layer supporting the detection element and the zone of absorbent material.

4. The analytical device as claimed in claim 1, further comprising a hinge connecting the lancet body to the frame element.

5. The analytical device as claimed claim 1, wherein the frame element and the lancet body are injection molded.

6. The analytical device as claimed in claim 1, wherein the test element includes an opening for receiving the lancet needle.

7. The analytical device as claimed in claim 6, wherein the opening is in the area of the detection element.

8. The analytical device as claimed in claim 1 further comprising a return spring situated in the lancet body for the lancet needle.

9. The analytical device as claimed in claim 1 further comprising a guide sleeve for the lancet needle in the lancet body.

10. The analytical device as claimed in claim 1, further comprising guide plates containing guide profiles on two opposing parallel sides of the frame element.

11. The analytical device as claimed in claim 1, wherein the lancet body includes a pair of external cams.

13. The system as claimed in claim 12, wherein the magazine contains complementary guide profiles for receiving the frame element of one of the analytical devices.

14. The system as claimed in claim 12, wherein the lancet body includes cams for causing movement of the lancet body relative to the frame element, and the magazine contains guide grooves for engaging the cams of the lancet body of one of the analytical devices.

16. The system as claimed in claim 15, wherein the measuring instrument contains complementary parallel guide profiles for guiding the frame element of the analytical device during movement relative to the measuring instrument.

17. The system as claimed in claim 15, wherein the lancet body includes cams for causing movement of the lancet body relative to the frame element, and the measuring instrument contains guide grooves for receiving the cams of the lancet body.

18. The system as claimed in claim 15, wherein the measuring instrument comprises a lancet plunger for driving the lancet of the analytical device when the lancet is in said lancing position.

20. The test element as claimed in claim 19 wherein the frame element includes a detection element, an opening in the area of the detection element for receiving the lancet needle, a separate zone of absorbent material, which is suitable for taking up excess sample liquid, in the immediate vicinity of the detection element, and a common support layer supporting the detection element and the zone of absorbent material.

21. The test element as claimed in claim 20 wherein the lancet body includes a guide sleeve for guiding movement of the lancet needle relative to the lancet body, and a return spring for returning the lancet needle to an initial position from any displaced position.

22. The test element as claimed in claim 21, further comprising a hinge connecting the lancet body to the frame element, the lancet body including a pair of external cams for causing movement of the lancet body relative to the frame element.

12. A system for storing analytical devices comprising a magazine and a store of analytical devices, each analytical device having a test element including a frame element defining a plane and a detection element connected to the frame element, and a lancet including a needle having a tip and a lancet body at least partially surrounding the needle, the lancet body being movably connected to the frame element such that the lancet can adopt a storage position wherein the needle is aligned essentially parallel to the plane of the test element and a lancing position wherein the needle is aligned essentially orthogonal to the plane of the test element.

15. A system for determining the presence or the content of an analyte in blood comprising:

a measuring instrument for measuring a change of a characteristic property of a test element which correlates with the analyte and a magazine suitable for holding a plurality of analytical devices, each analytical device having a test element including a frame element defining a plane and a detection element connected to the frame element, and a lancet including a needle having a tip and a lancet body at least partially surrounding the needle, the lancet body being movably connected to the frame element such that the lancet can adopt a storage position wherein the needle is aligned essentially parallel to the plane of the test element and a lancing position wherein the needle is aligned essentially orthogonal to the plane of the test element.

19. A test element comprising:

a frame element defining a plane and a lancet, the lancet containing a needle with a tip and a lancet body at least partially surrounding the lancet needle, the lancet body being movably connected to the frame element such that the lancet can adopt a storage position wherein the lancet needle is aligned essentially parallel to the plane of the frame element and a lancing position wherein the lancet needle is aligned essentially orthogonal to the plane of the frame element.