System for withdrawing small amounts of body fluid

• US 7,288,073 B2
• Filed: 08/30/2001
• Issued: 10/30/2007
• Est. Priority Date: 07/20/2001
• Status: Expired due to Term

• 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, Karl-Heinz
• Primary Examiner(s): Hindenburg; Max F.
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US09/943,080
• Publication Number:
  US 20030018282A1
• Time in Patent Office: 2,252 Days
• Field of Search: 600573-584, 604264-278, 604/46, 604/157, 606180-183, 436/180, 436/146, 436/148, 436/169, 436/177, 422 99-101
• US Class Current: 600/584
• 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

The present invention generally relates to a system for withdrawing small amounts if body fluid from an animal or human. The system comprises a holder and a disposable lancing unit attached to the holder. The lancing unit also comprises an open capillary channel for transporting the body fluid and piercing the skin.

Claims

1. A system for withdrawing body fluid, comprising:

a lancing unit configured to couple to a drive unit, the lancing unit including

a detection zone configured to analyze the body fluid, and

a capillary structure having a lancing tip configured to cut an incision in skin, the lancing tip defining a capillary groove for drawing the body fluid from the incision to the detection zone via capillary action, wherein the capillary groove opens longitudinally along the outside of the lancing tip to permit collection of the body fluid along the length of the lancing tip;

wherein the lancing unit includes a holding area in which a portion of the capillary structure is arranged;

wherein the holding area has a distal end from where the lancing tip extends and a top surface;

wherein the capillary groove opens along the top surface of the holding area;

wherein the lancing unit includes a plate capping the holding area;

wherein the plate covers a portion of the capillary groove; and

wherein the plate defines a window over the detection zone.

2. The system of claim 1, further comprising:

the drive unit, wherein the drive unit is coupled to the lancing unit.

3. The system of claim 1, wherein the capillary structure includes a pair of needles joined together.

4. The system of claim 1, wherein the capillary structure includes a solid needle with the capillary groove defined therein.

5. The system of claim 1, wherein the detection zone includes an optical detector for analyzing the body fluid.

6. The system of claim 1, wherein the detection zone includes an electrochemical detector for analyzing the body fluid.

7. The system of claim 1, wherein:

the lancing tip has a distal end that initially contacts the skin during lancing; and

the capillary groove further opens at the distal end of the lancing tip.

8. A system for withdrawing body fluid, comprising:

a lancing unit configured to couple to a drive unit, the lancing unit including

a detection zone configured to analyze the body fluid, and

a capillary structure having a lancing tip configured to cut an incision in skin, the lancing tip defining a capillary groove for drawing the body fluid from the incision to the detection zone via capillary action, wherein the capillary groove opens longitudinally along the outside of the lancing tip to permit collection of the body fluid along the length of the lancing tip; and

wherein the capillary structure includes a stranded wire with the capillary groove formed between adjacent wires.

9. An apparatus, comprising:

a disposable lancing device comprising

a holding area having a surface,

a lancing tip extending from the holding area for piercing skin, the lancing tip having a distal end that initially contacts the skin during piercing of the skin, the holding area and the lancing tip being a monolithic structure,

a detection zone disposed on the holding area for detecting analyte in body fluid, and

the holding area having an open capillary groove, the capillary groove opening along the surface of the holding area from the distal end of the lancing tip to the detection zone for transporting the body fluid via capillary action to the detection zone, the capillary groove being uncovered along the entire length of the lancing tip to permit collection of the body fluid along the entire length of the lancing tip.

10. The apparatus of claim 9, further comprising:

a drive unit coupled to the disposable lancing device for firing the disposable lancing device.

11. The apparatus of claim 9, wherein:

the lancing device includes a plate capping a portion of the capillary groove over the holding area; and

the plate defines a window over the detection zone.

12. The apparatus of claim 9, wherein the detection zone includes a reagent configured for optical detection of the analyte.

13. The apparatus of claim 9, wherein the detection zone includes a reagent configured for electrochemical detection of the analyte.

14. The apparatus of claim 9, wherein the capillary groove further opens at the distal end of the lancing tip.

15. The apparatus of claim 9, wherein the holding area is made from a semiconductor material.