System for withdrawing small amounts of body fluid

• US 20030018282A1
• Filed: 08/30/2001
• Published: 01/23/2003
• Est. Priority Date: 07/20/2001
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Hein, Heinz-Michael, Deck, Frank, Effenhauser, Carlo, Koelker, Harl-Heinz
• Granted Patent: US 7,288,073 B2
• Time in Patent Office: Days
• 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 5/150022 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 5/15045 comprising means for capillary action
• 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 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• CPC Class Codes: A61B 5/15115 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 5/15186 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
• CPC Class Codes: Y10T 29/49826 Assembling or joining

Abstract

System for withdrawing small amounts of body fluid comprising a drive unit which has a holder which is moved from a first into a second position when the drive unit is activated, and a disposable lancing unit which has a holding area that is removably positioned in the holder, the proximal end of an elongate capillary structure comprising at least one capillary channel for transporting body fluid being connected to the holding area and the distal end of the capillary structure being suitable for piercing skin, wherein the distal end of the capillary structure is located outside the skin when the holder is arranged in a first position and in the second position is inserted into the skin up to the puncture depth, characterized in that the at least one capillary channel is open to the outside in an area which comprises at least a part of the longitudinal extension of the capillary structure.

Disposable lancing unit for removing small amounts of body fluid which has a holding area to which the proximal end of an elongate capillary structure is connected to comprising at least one capillary channel to transport body fluid and the distal end of the capillary structure is suitable for piercing skin, characterized in that an area of the at least one capillary channel which comprises at least a part of the longitudinal extension of the capillary structure is open to the outside.

Claims

1. System for withdrawing small amounts of body fluid comprising

a drive unit which has a holder which is moved from a first into a second position when the drive unit is activated, and a disposable lancing unit which has a holding area that is removably positioned in the holder, the proximal end of an elongate capillary structure comprising at least one capillary channel for transporting body fluid being connected to the holding area and the distal end of the capillary structure being suitable for piercing skin,

wherein the distal end of the capillary structure is located outside the skin when the holder is arranged in said first position and in said second position is inserted into the skin up to the puncture depth, wherein

the at least one capillary channel is open to the outside in an area which comprises at least a part of the longitudinal extension of the capillary structure.

2. System as claimed in claim 1, in which the entire length of the capillary structure from the proximal to the distal end is open to the outside.

3. System as claimed in claim 1, in which the holding area has a detection zone for detecting one or several analytes, the detection zone being arranged such that it can take up body fluid from the capillary structure.

4. System as claimed in claim 1, in which the drive unit moves the lancing unit in such a manner that it remains in the second position for a time interval (collection period) and, subsequently, the lancing unit is moved into a position in which the distal end of the capillary structure is outside the skin.

5. System as claimed in claim 1, in which the drive unit moves the lancing device in such a manner that after reaching the second position it is moved back into a collecting position in which a section of the capillary structure located in the skin is shorter than in the second position.

6. System as claimed in claim 1, in which the capillary structure and holding area are integrally connected together.

7. System as claimed in claim 1 or 6, in which the holding area and capillary structure are manufactured from a semiconductor preferably silicon.

8. System as claimed in claim 6 or 7, in which the holding area and capillary structure are integrally manufactured from a single piece of material.

9. System as claimed in claim 1, in which the area of the capillary structure that is open to the outside has a channel shape.

10. System as claimed in claim 9, in which the channel-shaped area has an essentially V-shaped cross-section.

11. System as claimed in claim 1, in which the length of the capillary structure is in the range from 0.3 to 3 mm and the cross-section of the capillary structure is in the range from 0.03 to 0.8 mm.

12. Disposable lancing unit for withdrawing small amounts of body fluid which has a holding area to which the proximal end of an elongate capillary structure is connected, said capillary structure comprising at least one capillary channel to transport body fluid and the distal end of the capillary structure is suitable for piercing skin, wherein

an area of said at least one capillary channel which comprises at least a part of the longitudinal extension of the capillary structure is open to the outside.