Disposable lancet combined with a reagent carrying strip and a system for extracting and analysing blood in the body utilizing such a disposable lancet

• US 20010027277A1
• Filed: 03/14/2001
• Published: 10/04/2001
• Est. Priority Date: 03/24/2000
• Status: Active Grant

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Novo Nordisk A/S
• Inventors: Klitmose, Lars Peter
• Granted Patent: US 6,620,112 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 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150519 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 33/528 Atypical element structures, e.g. gloves, rods, tampons, toilet paper
• CPC Class Codes: G01N 33/66 involving blood sugars, e.g. galactose

Abstract

A disposable lancet combined with a reagent carrying strip which carries a reagent that indicates the concentration of a blood component in a blood sample placed in contact with the strip. The lancet has one end, which is sharpened for piercing the skin of a user and has the reagent carrying strip connected to the lancet e.g. by moulding. The strip is sheet-like and has a first side and a second side, which sides are both accessible for the user, such that the reagent carrying strip can be inserted into a blood glucose meter without having to disconnect the strip from the lancet. It is however possible to disconnect the strip from the lancet if so wanted.

Claims

1. A disposable lancet (1,10) combined with a reagent carrying strip (3), comprising a lancet (1,10), with a distal end (2), which is sharpened for piercing the skin of a user, and a reagent carrying strip (3), which carries a reagent that indicates the concentration of a blood component in a blood sample placed in contact therewith, characterized in that said reagent carrying strip (3) is a sheet-like strip (3) having a first side (4) and a second side (5), which sides (4,5) are both accessible for said user, and that said lancet (1,10) is connected to said reagent carrying strip (3).

2. A disposable lancet (1,10) combined with a reagent carrying strip (3) according to

claim 1

, characterized in that said lancet (1,10) is made from a moldable polymeric material, and that said reagent carrying strip (3) is attached to said lancet (1,10).

3. A disposable lancet (1,10) combined with a reagent carrying strip (3) according to

claim 1

or

2

characterized in that said reagent carrying strip (3,9) is made from a moldable polymeric material, which is moulded around said lancet (1,10).

4. A disposable lancet (1,10) combined with a reagent carrying strip (3) according to anyone of the claims 1 or 3, characterized in that said reagent carrying strip (3) has a number of edges between said first side (4) and said second side (5), and that said lancet (1,10) is attached to said reagent carrying strip (3) at one of these edges.

5. A disposable lancet (1,10) combined with a reagent carrying strip (3) according to

claim 4

, characterized in that said lancet (1,10) is connected to a frame (8), which frame (8) is attached to one or more of the edges of said reagent carrying strip (3).

6. A disposable lancet (1,10) combined with a reagent carrying strip (3) according to anyone of the preceding claims, characterized in that an arm (6) is connecting said lancet (1,10) to said reagent carrying strip (3) or to said frame (8).

7. A disposable lancet (1,10) combined with a reagent carrying strip (3) according to anyone of the preceding claims, characterized in that the connecting point (7) between the reagent carrying strip (3) or the frame (8) and the disposable lancet (1,10) or the arm (6) has a weakened tear line.

8. A disposable lancet (1,10) combined with a reagent carrying strip (3) according to anyone of the preceding claims, characterized in that said reagent carrying strip (3) is rectangular

9. A system (11) for extracting and analyzing blood in a body utilizing a disposable lancet (1,10) combined with a reagent carrying strip (3) according to anyone of the preceding claims, which system (11) comprises:

a housing (15) including a spring (16) actuated hammer (14), into which housing (15) said disposable lancet (1,10) combined with a reagent carrying strip (3) is placed in a guided position,

a button (13) which released said spring (16) actuated hammer (14), which then pushes forward said disposable lancet (1,10) combined with a reagent carrying strip (3), means for guiding said disposable lancet (1,10) combined with a reagent carrying strip (3) from a retracted position to a deployed position where the tip of said disposable lancet (1,10) combined with a reagent carrying strip (3) penetrates the skin of the user,

a sensor which senses the changes in the reagent placed on said reagent carrying strip (3),

a display (12) for showing a visual readout representing the changes in the reagent

characterized in that said sensor is situated in a position in said housing (15) where it can sense the changes in the reagent without manually moving said disposable lancet (1,10) combined with a reagent carrying strip (3).