Disposable diagnostic article

• US 20100049091A1
• Filed: 09/30/2009
• Published: 02/25/2010
• Est. Priority Date: 04/04/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Haar, Hans-Peter
• Granted Patent: US 8,298,159 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• 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 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/15107 Piercing being assisted by a triggering mechanism
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

A disposable diagnostic article comprising a lancing element that can be pierced into a body part and a collection area formed on the lancing element for body fluid obtained by the puncture is disclosed. The lancing element can comprise at least two bent parts folded towards each other such that the at least two bent parts can partially delimit the collection area.

Claims

1. A disposable diagnostic article for testing an analyte in a body fluid sample obtained from a body part, the article comprising:

a lancing element for puncturing the body part, wherein the lancing element comprises;

at least two bent parts folded towards each other, wherein the at least two bent parts are joined together at their ends to form a lancing member, and

a bending zone shaped by the bending and joining of the at least two bent parts, and

a collection area formed on the lancing element for collecting body fluid obtained by a puncture, wherein the at least two bent parts at least partially delimit the collection area.

2. The disposable diagnostic article according to claim 1, wherein the collection area is a capillary gap between the at least two bent parts

3. The disposable diagnostic article according to claim 1, wherein the collection area is continuously open on one side or continuously open on both sides along its longitudinal borders and pointing crosswise to a lancing direction.

4. The disposable diagnostic article according to the claim 1, wherein the at least two bent parts have opposing limiting surfaces for the collection area.

5. The disposable diagnostic article according claim 1, wherein the bending zone is formed at a proximal end of the lancing element.

6. The disposable diagnostic article according to claims 1, wherein the at least two bent parts are joined together by a welding spot.

7. The disposable diagnostic article according to claim 1, wherein the lancing element is formed by bending a single piece of flat material.

8. The disposable diagnostic article according to claim 7, wherein the single piece of flat material is a sheet-metal blank.

9. The disposable diagnostic article according to claim 1, further comprising, a test element to detect the analyte in the collected body fluid.

10. The disposable diagnostic article according to claim 9, wherein the test element is inserted into the lancing element as a prefabricated insert.

11. The disposable diagnostic article according to claim 9, wherein the lancing element comprises an opening for inserting the test element into the collection area.

12. The disposable diagnostic article according to claim 11, wherein the lancing element comprises an opening area in the proximal bending zone for inserting the test element into the collection area.

13. The disposable diagnostic article according to claim 9, further comprising,

a proximal end of the collection area forms a retainer for the test element.

14. The disposable diagnostic article according to claim 9, wherein the test element comprises a sensor area formed by a reagent layer which responds to the analyte, wherein the sensor area delimits a flow cross-section of the collection area.

15. The disposable diagnostic article according to claim 9, wherein the test element has at least one optical signal conductor, wherein the at least one optical signal conductor is connected to measuring electronics at a proximal contact section of the test element.

16. The disposable diagnostic article according to claim 1, wherein the lancing element is held in a carrier component for a forwards and backwards lancing movement.

17. The disposable diagnostic article according to claim 16, wherein the carrier component comprises,

a holder for inserting the lancing element, and

a coupling part for a drive coupling.

18. A diagnostic system for testing an analyte in body fluid sample obtained from a body part, the system comprising:

a housing,

an actuator located within the housing, and

at least one disposable diagnostic article in communication with the actuator to produce a lancing movement and with the body fluid sample.

19. A method for fabricating a disposable diagnostic article to be used for body fluid analyte testing, the method comprising:

shaping a lancing element to pierce a body part; and

providing a collection area on the lancing element to collect a body fluid obtained by a body part piercing, wherein the collection area is formed between at least two bent parts that are bent towards one another to form the lancing element and wherein the at least two bent parts are joined together at their ends by a joining means to form a bending zone.