Method and apparatus for a body fluid sampling device using illumination

• US 7,141,058 B2
• Filed: 04/24/2003
• Issued: 11/28/2006
• Est. Priority Date: 04/19/2002
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Freeman, Dominique M., Briggs, Barry Dean
• Primary Examiner(s): Hayes, Michael J.
• Assistant Examiner(s): ANDERSEN, MICHAEL T
• Application Number:
  US10/423,851
• Publication Number:
  US 20040092994A1
• Time in Patent Office: 1,314 Days
• Field of Search: 606/181, 600/583
• 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 body fluid sampling device for extracting bodily fluid from an anatomical feature is provided. The device comprises a penetrating member driver for driving a penetrating member to create a wound to extract bodily fluid; a light source positioned to indicate a point of sampling where the wound will be created, the light source indicating the point of sampling with a beam of light. The light source may be selected from one of the following: an LED, incandescent, fluorescent, or electroluminescent light source.

Claims

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

a penetrating member driver for driving a penetrating member to create a wound to extract said bodily fluid;

a light source positioned to indicate a point of sampling where said wound will be created, said light source indicating said point of sampling with a beam of light and

a sample chamber that includes electrodes, a volume no greater than 1 μ

L and an analyte detecting member, the sample chamber being positioned to receive fluid from a wound created by said penetrating member, and determine a concentration of an analyte in the fluid using a sample of less than 1 μ

L of the fluid, wherein when the penetrating member is removed from the sample chamber, the electrodes remain in the sample chamber and the volume of the sample chamber is less than 1 μ

L;

a position sensor coupled to the penetrating member drive, the position sensor utilizing position information of the penetrating member to determine a depth of penetration through a skin surface, the depth of penetration providing a volume of sample of less than 1 μ

L in the sample chamber.

2. The device of claim 1 wherein said light source is selected from one of the following:

a LED, incandescent, fluorescent, or electroluminescent light source.

3. The device of claim 1 wherein said light source comprises at least a first light source and a second light source.

4. The device of claim 1 wherein said light source comprises at least a first light source projecting a first color and at least a second light source projecting a second color.

5. The device of claim 1 wherein said light source provides a first color and a second color, wherein said second color is used when the device is aimed at a desired position, said first color being used during other conditions.

6. The device of claim 1 wherein said light source provides a first color and a second color when the device is aimed at a desired position, only said first color being used during other conditions.

7. The device of claim 1 further comprising a cartridge having a plurality of penetrating members, said cartridge adapted for use with the penetrating member driver.

8. The device of claim 1 wherein said driver comprises an electromechanical driver.

9. The device of claim 1 further comprising a sensor for receiving scattered light reflected from tissue at the point of sampling.

10. The device of claim 1 further comprising an optical train for directing light from the light source towards the point of sampling.

11. The device of claim 1 wherein said light source is configured to provide a plurality of individual beams or a continuous ring or other shape of light.

12. The device of claim 1 wherein said light source projects a continuous ring or other shape of light.

13. The device of claim 1 further comprising a housing containing said driver wherein a portion of said housing is made of a clear material.

14. The device of claim 1 wherein said light source is also used to provide illumination for analyte measurement.

15. A method comprising:

providing a penetrating member driver;

using a light source to project a beam which indicates a point of sampling of a penetrating member actuated by said driver;

aiming said driver to position said point of sampling at a desired location;

actuating said driver to advance said penetrating member and create a wound in tissue at the point of sampling; and

receiving fluid from the wound at a sample chamber that includes electrodes, a volume no greater than 1 μ

L and an analyte detecting member, wherein when the penetrating member is removed from the sample chamber, the electrodes remain in the sample chamber and the volume of the sample chamber is less than 1 μ

L;

determining a concentration of an analyte in the fluid in the sample chamber using a sample of less than 1 μ

L of the fluid; and

utilizing a position sensor coupled to the penetrating member drive to determine a depth of penetration of the penetrating memberthrough a skin surface, the depth of penetration providing a volume of sample of less than 1 μ

L in the sample chamber.

16. The method of claim 15 wherein said driver comprises an electromechanical driver.

17. The method of claim 15 wherein said light source projects a beam which shows one of the following at the point of sampling:

an X, a cross, a logo, an icon, a circle, a smiley face, a dot, or an arrow.

18. The method of claim 15 wherein said light source projects a beam having one of the following colors:

red, green, blue, gold, yellow, pink, purple or white.

19. The method of claim 15 further comprising using the beam of light to indicate readiness for service to the operator.

20. The method of claim 15 further comprising using the beam of light to indicate proximity of an anatomical structure.