Integrated lance and strip for analyte measurement

• US 20060030789A1
• Filed: 10/14/2005
• Published: 02/09/2006
• Est. Priority Date: 03/28/2003
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Lifescan Incorporated (Duv Holding Corporation)
• Inventors: Allen, John J.
• Granted Patent: US 7,473,264 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 17/32093 for skin incisions
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• 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 5/02035 Determining blood viscosity
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/15045 comprising means for capillary action
• CPC Class Codes: A61B 5/150458 Specific blade design, e.g. for improved cutting and penetration characteristics
• CPC Class Codes: A61B 5/150465 Specific design of proximal end
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/15167 Characterized by a folded strip
• CPC Class Codes: A61B 5/6848 Needles

Abstract

The present invention relates, in general, to lancing elements for use in drawing bodily fluids out of a patient and, more particularly, to an improved lancing element including first and second elements positioned relative to each other such that an incision formed by the first element is held open by the second element and bodily fluids are pulled up the lancing element by surface tension on the first and second lancing elements.

Claims

1. A lance comprising:

a lancing element having a sharpened tip;

a separation element having a separation tip, wherein said separation tip is positioned proximal to said sharpened tip;

a connector connecting a proximal portion of said lancing element to a proximal portion of said separation element, said connector forming a fill channel,

wherein said lancing element protects said separation tip from initiating a puncture when launching said lance into a user'"'"'s skin;

2. The lance according to claim 1, wherein said lancing element has a sharpness angle formed by two lancing element sides, wherein said two lancing element sides converge at a vertex coincident with said sharpened tip, said sharpness angle ranging from about 10°

to about 25°

.

3. The lance according to claim 1, wherein said lancing element, said separation element and said fill channel are formed from a single sheet of metal.

4. The lance according to claim 1, wherein said fill channel comprises an upper chamber wall and a lower chamber wall, wherein said upper chamber wall is orientated with respect to said lower chamber wall to form a fold angle, wherein said fold angle ranges from about 10°

to about 30°

.

5. The lance according to claim 1, wherein said fill channel comprises an upper chamber wall and a lower chamber wall,

said upper chamber wall being connected to a proximal portion of said lancing element,

said lower chamber wall being connected to a proximal portion of said separation element;

said lance having a plane approximately parallel to said upper chamber wall and coincident with said sharpened tip,

wherein said separation tip is positioned on a side of said plane closer to said upper chamber.

6. The lance according to claim 1, wherein a space between said lancing element and said separation element forms a gap, said gap increasing in size proximal to said separation tip.

7. The lance in accordance with claim 1, wherein a proximal end of said fill channel is integrated into a sensor strip.

8. A sensor strip comprising:

said lance in accordance with claim 1;

a main body;

wherein said lance and said main body are formed from a single sheet of material, wherein a proximal end of said lance connects to a distal end of said main body, and

a rib, wherein said rib is an embossment of said single sheet of material and said rib is deposed on a portion of said proximal end of said lance and on a portion of said distal end of said main body, whereby said rib strengthens a bending rigidity of said lance with respect to said main body.

9. A method of lancing a user'"'"'s skin using said lance of claim 1, said method comprising the steps of:

launching said lance towards a user'"'"'s skin;

initiating a puncture of said user'"'"'s skin with said sharpened tip to form a wound;

slicing said user'"'"'s skin and enlarging said wound with said lancing element as said lance continues to move into said user'"'"'s skin, wherein said lancing element has two lancing element sides adapted for slicing said user'"'"'s skin;

spreading said wound with said separation element, said separation element adapted for spreading said wound;

enabling bodily fluid to flow from a distal end of said lance to said fill channel and then to a working electrode and a reference electrode used for measuring an analyte.