Test device in particular for blood sugar tests

• US 8,574,169 B2
• Filed: 09/16/2011
• Issued: 11/05/2013
• Est. Priority Date: 03/17/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hoenes, Joachim
• Primary Examiner(s): DOUGHERTY, SEAN PATRICK
• Application Number:
  US13/235,027
• Publication Number:
  US 20120071791A1
• Time in Patent Office: 781 Days
• Field of Search: 600/573, 600/583, 606181-186
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150435 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable

Abstract

The invention concerns a test device, in particular for blood sugar tests, comprising a lancing element which is provided with a lancing component for producing a skin puncture, and a protecting element shielding the lancing element at least in the area of the lancing component. According to the invention it is proposed that the lancing element has a collecting structure for collecting body fluid from the skin puncture and that the protecting element comprises a protecting foil to cover the collecting structure and a holding body for holding the protecting foil on the lancing element.

Claims

1. A test device for blood sugar tests, comprising a lancing element which is provided with a lancing component for producing a skin puncture, and a protecting element shielding the lancing element at least in a region of the lancing component, wherein the lancing element has a collecting structure for collecting body fluid from the skin puncture and the protecting element has a protecting foil to cover the collecting structure, wherein the protecting element has an injection molded holding body directly molded onto the lancing element and configured for holding the protecting foil.

2. The test device according to claim 1, wherein the collecting structure is formed by a recess in the lancing component that can be filled with body fluid and is in a form of a groove that is open on one side or a cut-out that is open on both sides, and that the recess is covered by the protecting foil when the lancing element is in an unused state.

3. The test device according to claim 1, wherein the lancing element has a hydrophilic coating which is covered by the protecting foil at least in some areas.

4. The test device according to claim 1, wherein the protecting foil and the holding body are in a common movable arrangement on the lancing element or capable of being jointly removed from the lancing element, so that the lancing component and the collecting structure are exposed when the lancing element is in use.

5. The test device according to claim 1, wherein the lancing component can be inserted into the skin while piercing the holding body or the protecting foil.

6. The test device according to claim 1, wherein the protecting element forms a stop against the skin or against an abutment when the skin puncture is produced.

7. The test device according to claim 1, wherein the protecting foil forms a two-layered foil envelope or a single-layered foil cover.

8. The test device according to claim 1, wherein the protecting foil rests loosely on the lancing component or is releasably adhesively connected to the lancing component.

9. The test device according to claim 1, wherein the holding body forms a permanent composite with the protecting foil, wherein the holding body completely encloses the protecting foil or encloses the protecting foil at one end section.

10. The test device according to claim 1, wherein the holding body is made of an elastomer material.

11. The test device according to claim 1, wherein the holding body is molded to the lancing element adjacent an edge part reaching over the protecting foil in a germ-tight manner.

12. The test device according to claim 1, wherein the protecting element is designed to maintain a sterility of at least the lancing component in an unused state or to enable at least the lancing component to be hygienically disposed of in a used state.

13. The test device according to claim 1, wherein the collecting structure to which body fluid is applied can be brought into contact with an analytical test element that reacts to an analyte in the body fluid by means of a transfer movement so that body fluid is transferred from the collecting structure onto the test element.

14. The test device according to claim 1, wherein the holding body forms a guide member to control any movement of the lancing element.

15. A method for the production of a test device, comprising:

providing a lancing element having a lancing component for producing a skin puncture and a collecting structure for collecting body fluid from the skin puncture,

covering the lancing element with a protecting element comprising a protecting foil at least in the area of the collecting structure,

providing an injection molded holding body directly molded onto the lancing element, configured for holding the protecting foil onto the lancing element, and

incorporating the lancing element in the test device.