Method and apparatus for body fluid sampling and analyte sensing

• US 7,892,185 B2
• Filed: 09/30/2008
• Issued: 02/22/2011
• Est. Priority Date: 04/19/2002
• Status: Expired due to Fees

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Alden, Don, Freeman, Dominique
• Primary Examiner(s): Hoekstra; Jeffrey G
• Application Number:
  US12/241,564
• Publication Number:
  US 20090054813A1
• Time in Patent Office: 875 Days
• Field of Search: 600/573, 600/576, 600/577, 600/578, 600/579, 600/583, 600/584, 601/171, 601/172, 601/180, 601/181, 601/182, 601/183, 601/184, 601/185, 601/186
• US Class Current: 600/583
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150358 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 5/150519 Details of construction of hub, i.e. element used to attach the single-ended needle to a piercing device or sampling device
• CPC Class Codes: A61B 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/150664 Pivotable protective sleeves, i.e. sleeves connected to, or integrated in, the piercing or driving device, and which are pivoted for covering or uncovering the piercing element
• CPC Class Codes: A61B 5/150824 by visual feedback
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• CPC Class Codes: A61B 5/150916 by blocking components, e.g. piston, driving device or fluid passageway
• 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 5/15117 comprising biased elements, resilient elements or a spring, e.g. a helical spring, leaf spring, or elastic strap
• CPC Class Codes: A61B 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/1513 comprising linear sliding guides comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15146 Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• 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 5/15163 Characterized by propelling the piercing element in an axial 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 5/15182 : 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

Abstract

A body fluid sampling system is provided for use on a tissue site. In one embodiment, the system comprises a cartridge; a penetrating member driver; a plurality of penetrating members arranged in a radial configuration on the cartridge wherein sharpened distal tips of the penetrating members point radially outward; wherein an active one of the penetrating members may be operatively coupled to the penetrating member driver, the penetrating member driver moving the active one along a path out of a housing having a penetrating member exit, into the tissue site, stopping in the tissue site, and withdrawing out of the tissue site; and a plurality of analyte detecting members, wherein at least one of the analyte detecting members is positioned to receive fluid from a wound created by the active one of the penetrating members, wherein the detecting members are not pierced by the active one of the penetrating members.

Claims

1. A body fluid sampling system for use on a tissue site, the system comprising:

a cartridge;

a penetrating member driver;

a plurality of penetrating members arranged in a radial configuration in an interior of the cartridge wherein sharpened distal tips of the penetrating members point radially outward;

wherein an active one of said penetrating members is configured to be operatively coupled to said penetrating member driver, said penetrating member driver moving said active one along a path out of a housing having a penetrating member exit, into said tissue site, stopping in said tissue site, and withdrawing out of said tissue site;

a plurality of analyte detecting members positioned in the interior of the cartridge, wherein at least one of said analyte detecting members is positioned to receive the body fluid from a wound created by said active one of said penetrating members, wherein said analyte detecting members are not pierced by the active one of the penetrating members, and wherein said analyte detecting members are sized to receive no more than about 1.0 μ

L of the body fluid;

a processor coupled to the penetrating member driver for controlling the penetrating member velocity into the tissue site; and

a position sensor coupled to the processor and the penetrating member driver, the position sensor positioned to provide an indication of a position of the penetrating member during actuation, the position sensor coupled to a detection algorithm configured to provide feedback velocity information to the processor, wherein the processor modulates the penetrating member driver to control penetrating member velocity based on the feedback velocity information.