Test element with elastically mounted lancet

• US 20070182051A1
• Filed: 02/09/2007
• Published: 08/09/2007
• Est. Priority Date: 02/09/2006
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Harttig, Herbert
• Granted Patent: US 8,062,232 B2
• Time in Patent Office: Days
• US Class Current: 264/138
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/150442 Blade-like piercing elements, e.g. blades, cutters, knives, for cutting the skin
• CPC Class Codes: A61B 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15173 Characterized by propelling the piercing element parallel to the direction of movement of the strip

Abstract

This invention generally relates to a method for producing an analytical system, and to a analytical system for detecting an analyte in a body fluid. The analytical system comprises a test element and a lancet which is movable relative to the test element and which is received on the test element. The lancet is connected to the test element via an elastomer spring.

Claims

1. An analytical system for detecting an analyte in a body fluid, the system comprising:

a test element; and

a lancet movable relative to the test elements and received on the test element, wherein the lancet is connected elastically to the test element via an elastomer spring.

2. The system according to claim 1, wherein the lancet is oriented parallel to the longitudinal axis of the test element.

3. The system according to claim 1, wherein the elastomer spring has at least one resilient area that extends on both sides of the lancet.

4. The system according to claim 3, wherein the at least one resilient area extends, in relation to the longitudinal axis of the test element, in an arrow shape toward the front edge of the test element.

5. The system according to claim 3, wherein the at least one resilient area is designed in the form of a cord, or a thread or a strip.

6. The system according to claim 3, wherein the at least one resilient area of the elastomer spring is defined by incisions, punches or cuttings made in the elastomer material.

7. The system according to claim 3, wherein the elastomer spring is made of a rubber elastic material.

8. The system according to claim 3, wherein the elastomer spring, in the at least one resilient area, has a reduced thickness of less than 200 μ

m.

9. The system according to claim 3, wherein the at least one resilient area extends from the lancet body of the lancet to a first longitudinal side and to a second longitudinal side of the test element.

10. The system according to claim 9, wherein on the first longitudinal side and on the second longitudinal side of the test element, there are first and second widened areas, respectively, which serve as spring abutments of the elastomer spring.

11. The system according to claim 10, wherein the first and second widened areas are designed in a thickness which corresponds to ¼

to 5/4 of the thickness of the lancet.

12. The system according to claim 10, wherein the first and second widened areas of the test element, on the first and second longitudinal sides of the test element, are offset, with respect to the longitudinal axis of the test element, in relation to a plastic sheath of the lancet.

13. The system according to claim 1, wherein the lancet has a lancet tip that is flush with a capillary which extends on a front face or on a rear face of the test element and which opens out on a front edge of the lancet system.

14. The system according to claim 1, wherein the lancet is sealed in a sterile manner by a film pouch made from a sterile protective band of film.

15. The system according to claim 14, wherein the film pouch is connected to the test element along a peripheral edge thereof.

16. The system according to claim 14, wherein the film pouch is provided, on the front edge of the lancet system, with a fold.

17. The system according to claim 1, wherein a recess contour is created in a surface of the test element, inside which receiving recess a blunt end of the lancet can be exposed.

18. The system according to claim 1, wherein the lancet is designed in the form of a needle with a circular cross section or is designed as a flat lancet which has a substantially rectangular cross section.

19. The system according to claim 1, wherein the length of the lancet is shorter than the longitudinal extent of the test element to which the lancet is elastically connected.

20. A method for producing an analytical system, for detection of an analyte in a body fluid, the method comprising:

a) forming a continuous band of a large number of spaced-apart lancets from a hot-melt elastomer;

b) producing at least one resilient area of an elastomer spring in the continuous band;

c) applying to the continuous band a sterile protective band of film;

d) creating a film pouch from the application of the sterile protective band of film that keeps the lancet system sterile; and

e) joining the sealed lancet system to a spacer layer which forms the test element and in which the capillary extends and a measurement area is formed for determining an analyte in a body fluid.

21. The method according to claim 20, wherein the at least one resilient area of an elastomer spring is produced by means of incisions, cuttings or punches.

22. The method according to claim 20, wherein the lancets are spaced apart from one another by the width of one test element.

23. The method according to claim 20, wherein the lancets are covered with a plastic sheath that extends by a length which is at least 1/20 of the length of the lancet body.

24. The method according to claim 20, wherein, in the continuous band between two lancets, first and second widened areas are formed in a width which is at least 1/20 and at most 1/4 of the width of the test element.

25. The method according to claim 24, wherein between the lancet and the first and second widened areas of the continuous band, the second widened is formed in a reduced thickness of less than 200 μ

m.

26. The method according to claim 20, wherein the system is applied to the sterile protective band of film whose width corresponds to at least twice the length of the lancet.

27. The method according to claim 26, wherein the continuous band and the sterile protective band of film are joined together by heat.

28. The method according to claim 20, wherein the continuous band is thermally sealed in the film pouch and is then subjected to a sterilization process.

29. The method according to claim 28, wherein the continuous band is thermally sealed in the film pouch and sterilized by radiation.

30. The method according to claim 20, wherein the system is produced as a layered structure comprising a cover film, a spacer layer with capillaries formed therein, a support band, an adhesive layer, and the continuous band sealed in a film pouch.