LANCET HAVING CAPILLARY CHANNEL AND STERILE PROTECTION ELEMENT AND METHOD FOR PRODUCING SUCH A LANCET

• US 20120022345A1
• Filed: 07/21/2011
• Published: 01/26/2012
• Est. Priority Date: 01/21/2009
• 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 8,608,669 B2
• Time in Patent Office: Days
• US Class Current: 600/309
• 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 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150557 Protectors removed by bending
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150717 manually removed
• CPC Class Codes: A61B 5/15105 Purely manual piercing, i.e. the user pierces the skin without the assistance of any driving means or driving devices
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

Lancets comprising a piercing element for puncturing the skin of a patient, a test region containing detection reagents for determining an analyte concentration of a body fluid sample, a capillary structure arranged in the piercing element for transporting a body fluid sample to the test region, and a sterile protection element, which encloses the tip of the piercing element. The capillary structure is blocked in a section surrounded by the sterile protection element. Also provided are methods for producing a lancet, comprising: producing a piercing element, which on the upper side has an upwardly open capillary structure; covering a section of the upper side of the piercing element and blocking the capillary channel in this section using a first material; covering a section of the underside using a second material; sterilizing the piercing element; and attaching a test region containing detection reagents to the piercing element.

Claims

1-15. -15. (canceled)

16. A lancet, comprising:

a piercing element for puncturing the skin of a patient;

a test region containing detection reagents for determining an analyte concentration of a body fluid sample;

a capillary channel arranged in the piercing element for transporting a body fluid sample to the test region, wherein the capillary channel is a groove or a continuous slot; and

a sterile protection element, which encloses the tip of the piercing element, the sterile protection element comprising a first component covering a section of an upper side of the piercing element and filling in the capillary channel in the covered section, and a second component covering a section of an underside of the piercing element;

wherein the capillary channel is blocked in a section surrounded by the sterile protection element.

17. The lancet according to claim 16, wherein the capillary channel is blocked by the sterile protection element filling in the capillary channel at least over a part of the length.

18. The lancet according to claim 16, wherein the lancet protrudes from the sterile protection element.

19. The lancet according to claim 16, wherein at least one of the two components is a film.

20. The lancet according to claim 16, wherein the first component is porous.

21. The lancet according to claim 20, wherein the first component is a polymer foam.

22. The lancet according to claim 16, wherein a film is glued to the side the first component facing away from the piercing element.

23. The lancet according to claim 22, wherein the film glued to the first component is also glued to a part of the lancet that protrudes from the sterile protection element.

24. The lancet according to claim 16, wherein the first component is thicker than the second component.

25. The lancet according to claim 24, wherein the first component is at least ten times as thick as the second component.

26. The lancet according to claim 16, wherein the piercing element is fastened to a carrier body, which carries the test region.

27. A carrier strip comprising a plurality of lancets according to claim 16, arranged thereon.

28. A method for producing a lancet, comprising:

a) producing a piercing element, which on the upper side comprises an upwardly open capillary channel;

b) covering a section of the upper side of the piercing element with a first material;

c) covering a section of the underside using a second material;

d) sterilizing the piercing element; and

e) attaching a test region containing detection reagents to the piercing element;

wherein the capillary channel is filled in the covered section with the first material.

29. The method according to claim 28, wherein the first material is pressed into the capillary channel.