Method and apparatus for body fluid sampling with improved sensing

• US 7,297,151 B2
• Filed: 05/02/2003
• Issued: 11/20/2007
• Est. Priority Date: 04/19/2002
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Elikan Technologies Incorporated
• Inventors: Boecker, Dirk, Freeman, Dominique M.
• Primary Examiner(s): Dawson; Glenn K.
• Assistant Examiner(s): SONNETT, KATHLEEN C
• Application Number:
  US10/429,196
• Publication Number:
  US 20040092995A1
• Time in Patent Office: 1,663 Days
• Field of Search: 606181-185, 606/167, 600/583, 436/63, 436/808
• US Class Current: 606/181
• CPC Class Codes: A61B 17/8863 Apparatus for shaping or cutting osteosynthesis equipment by medical personnel
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14551 for measuring blood gases
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150152 by an adequate mechanical impact on the puncturing location
• CPC Class Codes: A61B 5/150167 Adjustable piercing speed of skin piercing element, e.g. blade, needle, lancet or canula, for example with varying spring force or pneumatic drive
• CPC Class Codes: A61B 5/150175 Adjustment of penetration depth
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150358 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 5/150755 Blood sample preparation for further analysis, e.g. by separating blood components or by mixing
• CPC Class Codes: A61B 5/150824 by visual feedback
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc
• CPC Class Codes: A61B 5/15169 Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/15182 : Means for keeping track or checking of the total number of piercing elements already used or the number of piercing elements still remaining in the stocking, e.g. by check window, counter, display
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: Y10S 436/808 : Automated or kit

Abstract

A device is provided for use with a body fluid sampling device for extracting bodily fluid from an anatomical feature. The device comprises a cartridge having a plurality of cavities. The device may include a plurality of penetrating members each at least partially contained in the cavities of the cartridge wherein the penetrating members are slidably movable to extend outward from openings on the cartridge to penetrate tissue. The device may also include a plurality of analyte detecting members and a plurality of chambers. Each chamber may be associated with one of the cavities, the chambers positioned along an outer periphery of the cartridge, wherein at least one of said analyte detecting members forms a portion of one wall of one of said plurality of chambers. In one embodiment, the device may also include a fluid spreader positioned over at least a portion of said analyte detecting member to urge fluid toward one of the detecting members.

Claims

1. A device for use with a body fluid sampling device for extracting bodily fluid from an anatomical feature, said device comprising:

a cartridge having a plurality of cavities;

a plurality of penetrating members, at least one of said plurality of penetrating members being contained in one of said plurality of cavities of the cartridge, the penetrating members being slidably movable to extend outward from openings on said cartridge to penetrate tissue;

a plurality of analyte detecting members;

a plurality of sample chambers, each associated with one of said cavities, said sample chambers being positioned along an outer periphery of said cartridge;

wherein at least one of said analyte detecting members forms a portion of one wall of one of said plurality of sample chambers; and

a position sensor coupled to the plurality of penetrating members, and to a processor;

the position sensor

and processor measuring a distance from an initialization point to a point of contact of a penetrating member to a target tissue surface, the penetrating member being retracted by a drive force generator to the initialization point with a distance to the target tissue being measured and a depth of penetration of the penetrating member determined.

2. The device of claim 1 further comprising a fluid spreader positioned over at least a portion of said analyte detecting member to urge fluid toward one of the detecting members.

3. The device of claim 1 wherein said penetrating members each have a tip, wherein at least one tip has a starting position in one of said plurality of sample chambers.

4. The device of claim 1 wherein said analyte detecting members are electrochemical.

5. The device of claim 1 wherein at least one of said sample chambers includes an opening on one of its surfaces, said opening leading fluid to an analyte detecting member.

6. The device of claim 1 wherein at least one of said sample chambers includes an opening on one of its surfaces, wherein one of said analyte detecting members is contained within said opening.

7. The device of claim 1 wherein at least one of said sample chambers includes an opening on one of its surfaces, wherein one of said analyte detecting members is visible through said opening.

8. The device of claim 1 wherein at least one of said sample chambers includes an opening on one of its surfaces, wherein one of said analyte detecting members is positioned so that the opening opens directly onto the detecting member.

9. The device of claim 1 further comprising a mesh configured fluid spreader positioned over an analyte sensing member.

10. The device of claim 1 further comprising a penetrating member driver.

11. A device for use with a body fluid sampling device for extracting bodily fluid from an anatomical feature, said device comprising:

a cartridge having a plurality of cavities and a plurality of sample chambers;

a plurality of penetrating members, at least one of said plurality of penetrating members being contained in one of said plurality of cavities, the penetrating members being slidably movable to extend outward from openings on said cartridge to penetrate tissue;

a plurality of analyte detecting members positioned in the plurality of sample chambers;

wherein each of a sample chamber is positioned substantially adjacent an outer periphery of said cartridge;

wherein at least one of said analyte detecting members forms a portion of one wall of one of said plurality of sample chambers; and

a position sensor coupled to the plurality of penetrating members, the position sensor measuring a distance from an initialization point to a point of contact of a penetrating member to a target tissue surface, the penetrating member being retracted by a drive force generator to the initialization point with a distance to the target tissue being measured and a depth of penetration of the penetrating member determined.

12. The device of claim 11 further comprising a plurality of ribs, each associated with one of said sample chambers.

13. A device for use with a body fluid sampling device for extracting bodily fluid from an anatomical feature, said device comprising:

a cartridge having a plurality of sample chambers;

a plurality of penetrating members, at least one of said plurality of penetrating members being contained in said cavities each of a penetrating member being slidably movable to extend outward from an opening on said cartridge to penetrate tissue;

a plurality of analyte detecting members;

wherein each of a sample chamber being positioned substantially adjacent an outer periphery of said cartridge;

at least one opening in one of said sample chambers leading fluid along a fluid path towards one of said analyte detecting members; and

a position sensor coupled to the plurality of penetrating members, the position sensor measuring a distance from an initialization point to a point of contact of a penetrating member to a target tissue surface, the penetrating member being retracted by a drive force generator to the initialization point with a distance to the target tissue being measured and a depth of penetration of the penetrating member determined.

14. The device of claim 13 wherein said fluid path contains a channel sized to hold no more than 1 microliter.