Disposable diagnostic part and a method for the manufacture thereof

• US 8,858,466 B2
• Filed: 02/15/2010
• Issued: 10/14/2014
• Est. Priority Date: 08/16/2007
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Fuerst, Otto, Haar, Hans-Peter
• Primary Examiner(s): HENSON, DEVIN B
• Application Number:
  US12/705,680
• Publication Number:
  US 20100168617A1
• Time in Patent Office: 1,702 Days
• Field of Search: 600/573, 600/576, 600/577, 600/583, 606/181
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• 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 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• 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 5/150419 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 5/150519 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/15115 Driving means for propelling the piercing element to pierce the skin, e.g. comprising mechanisms based on shape memory alloys, magnetism, solenoids, piezoelectric effect, biased elements, resilient elements, vacuum or compressed fluids
• CPC Class Codes: A61B 5/15142 Devices intended for single use, i.e. disposable
• CPC Class Codes: A61B 5/15153 Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/411 Detecting or monitoring allergy or intolerance reactions to an allergenic agent or substance

Abstract

The invention concerns a disposable diagnostic part comprising a lancing element (14) which is designed for puncturing the skin (26) and has a collecting channel (16) for taking up body fluid, and comprising a detection element (18) which has a test layer (42) provided with reagents for the detection of an analyte in the body fluid and is disposed in the collecting channel (16). In order to ensure an improved stability and biocompatibility it is proposed that the detection element (18) is provided with a sealing layer (20) that is applied to the test layer (42) and covers the reagents.

Claims

1. Disposable diagnostic part comprising a lancing element which is designed for puncturing the skin and has a laterally open collecting channel for taking up body fluid, and comprising a detection element which has a test layer provided with reagents for the detection of an analyte in the body fluid and is disposed in the collecting channel, characterized in that the detection element is provided with a sealing layer which is applied to the test layer and covers the reagents, wherein the sealing layer is distinct from the reagents, wherein the sealing layer is disposed in the collecting channel, wherein the sealing layer seals the reagents from an outside environment and prevents particles of reagent detaching from the test layer, wherein the lancing element has a tip for puncturing the skin, wherein the sealing layer is provided over the test layer and is located between the reagent and the tip.

2. Disposable diagnostic part according to claim 1, characterized in that the sealing layer is dissolvable when the collecting channel is filled by body fluid so that the analyte comes into contact with the reagents.

3. Disposable diagnostic part according to claim 1, characterized in that the time required to dissolve the sealing layer in the body fluid is less than 10 s.

4. Disposable diagnostic part according to claim 3, wherein the time required to dissolve the sealing layer in the body fluid is less than 2 s.

5. Disposable diagnostic part according to claim 1, characterized in that the sealing layer is in the form of a liquid film.

6. Disposable diagnostic part according to claim 1, characterized in that the sealing layer encloses a margin of the detection element which borders the test layer.

7. Disposable diagnostic part according to claim 1, characterized in that the detection element has a support formed from a flat material.

8. Disposable diagnostic part according to claim 1, characterized in that the lancing element consists of metal.

9. Disposable diagnostic part according to claim 1, characterized in that the test layer is provided with a substance that is also present in the sealing layer.

10. Disposable diagnostic part according to claim 8, wherein the metal includes steel.

11. Disposable diagnostic part according to claim 1, characterized in that the detection element is firmly inserted into an end section of the collecting channel and the test layer is aligned in the lancing direction of the lancing element.

12. Disposable diagnostic part according to claim 1, characterized in that the sealing layer is formed from non-ionic surfactants.

13. Disposable diagnostic part according to claim 1, wherein the reagents include enzymes.

14. Disposable diagnostic part according to claim 1, wherein the sealing layer is positioned transverse to a flow direction of the body fluid in the collecting channel.

15. Disposable diagnostic part comprising a lancing element which is designed for puncturing the skin and has a laterally open collecting channel for taking up body fluid, and comprising a detection element which has a test layer provided with reagents for the detection of an analyte in the body fluid, characterized in that the detection element is at least partially provided with a sealing layer formed from non-ionic surfactants, wherein the sealing layer is distinct from the test layer, wherein the sealing layer completely covers the test layer such that a margin surrounding the test layer is covered by the sealing layer to prevent detachment of particles of the reagent, wherein the sealing layer is located so that the body fluid contacts the sealing layer before contacting the test layer, wherein the sealing layer is dissolvable when the collecting channel is filled by body fluid so that the analyte comes into contact with the reagents.

16. Disposable diagnostic part according to claim 15, characterized in that the non-ionic surfactants contain a polysorbate.

17. Disposable diagnostic part according to claim 16, wherein the polysorbate includes polysorbate 20.

18. Disposable diagnostic part according to claim 17, wherein the polysorbate includes polysorbate 80.

19. Disposable diagnostic part according to claim 16, wherein the polysorbate includes polysorbate 80.

20. Disposable diagnostic part according to claim 15, characterized in that the non-ionic surfactants contain poloxamer.

21. Disposable diagnostic part according to claim 20, wherein the poloxamer includes poloxamer 188.

22. Disposable diagnostic part according to claim 15, characterized in that the non-ionic surfactants contain at least one substance selected from the group comprising fatty alcohol polyglycol ethers, glucamides, fatty alcohol ethoxylates, alkyl-polyglycosides, sucrose fatty acid esters.

23. Disposable diagnostic part according to claim 15, characterized in that the sealing layer covers a part of the lancing element which penetrates into the skin.

24. Disposable diagnostic part according to claim 15, characterized in that the sealing layer forms a hydrophilic surface for the uptake of body fluid during skin puncture.

25. Magazine for holding a plurality of disposable diagnostic parts according to claim 15 for use in a hand-held device especially for the determination of blood sugar.

26. System for analysing a body fluid in particular as a hand-held device for determining blood sugar comprising at least one disposable diagnostic part according to claim 15 which is disposed therein or can be inserted therein.

27. Disposable diagnostic part according to claim 15, wherein the reagents include enzymes.

28. Disposable diagnostic part according to claim 15, wherein the sealing layer is positioned transverse to a flow direction of the body fluid in the collecting channel.