Method and apparatus for a multi-use body fluid sampling device with analyte sensing

• US 8,574,168 B2
• Filed: 03/26/2007
• Issued: 11/05/2013
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique, Boecker, Dirk
• Primary Examiner(s): Towa, Rene
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US11/691,306
• Publication Number:
  US 20070219574A1
• Time in Patent Office: 2,416 Days
• Field of Search: 600/573, 600/583, 600/584, 606/185, 606181-182
• US Class Current: 600/583
• CPC Class Codes: A61B 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/1427 Multiple blood sampling, e.g. at periodic or pre-established intervals
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• 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 5/150221 Valves
• 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 5/150427 Specific tip design, e.g. for improved penetration characteristics
• 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 5/150519 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 5/151 : Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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 5/15153 : Multiple piercing elements stocked in a single 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 5/15178 : Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184
• 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 5/15184 : Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• 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: A61M 37/0015 : by using microneedles

Abstract

A device for use with a penetrating member driver to penetrate tissue is provided. A plurality of penetrating members are coupled to a single cartridge and are operatively couplable to the penetrating member driver. The penetrating members are movable to extend radially outward from the cartridge to penetrate tissue. A plurality of analyte sensors are coupled to the single cartridge and are positioned on the cartridge to receive body fluid from a wound in the tissue created by the penetrating member.

Claims

1. A tissue penetration device, comprising:

an electronic penetrating member driver;

a disposable;

a plurality of penetrating members on a support and positioned in the disposable, each of the penetrating members coupled to the penetrating member driver when advanced along a path into a tissue target, wherein the support has a plurality of openings, each associated with a penetrating member for the penetrating member to exit;

a fracturable sterility barrier disposed on an outer surface of the support covering the plurality of openings without contacting the penetrating member; and

a device that breaks a portion of the fraturable sterility barrier covering the opening associated with the penetrating member during launch of the penetrating member so that the penetrating member exits the opening without contacting the sterility barrier; and

a plurality of analyte sensors each in a sample chamber, each of a sample chamber being associated with a the penetrating member, each of a sample chamber being positioned in the disposable to receive body fluid from a wound in the tissue created by the penetrating member and having a volume of no greater than 1 microliter.

2. A tissue penetration device, comprising:

an electronic penetrating member driver;

a disposable;

a plurality of penetrating members on a support and positioned in the disposable, each of a penetrating member coupled to the penetrating member driver when advanced along a path into a tissue target, wherein the support has a plurality of openings, each associated with a penetrating member for the penetrating member to exit;

a plurality of analyte sensors each in a sample chamber, each of a sample chamber being associated with a penetrating member, each of a sample chamber being positioned on the disposable to receive body fluid from a wound in the tissue created by the penetrating member and having a volume of no greater than 1 microliter;

a fracturable sterility barrier disposed on an outer surface of the support covering the plurality of openings without contacting the penetrating member; and

wherein the support has a plurality of openings, each of an opening associated with a penetrating member, wherein the tip of the penetrating member configured to move that portion of the fracturable sterility barrier covering the opening associated with the penetrating member out of the way of the penetrating member before launch of the penetrating member.

3. A tissue penetration device, comprising:

an electronic penetrating member driver;

a disposable;

a plurality of penetrating members on a support and positioned in the disposable, each of a penetrating member coupled to the penetrating member driver when advanced along a path into a tissue target, wherein the support has a plurality of openings, each associated with a penetrating member for the penetrating member to exit;

a plurality of analyte sensors each in a sample chamber, each of a sample chamber being associated with a penetrating member, each of a sample chamber being positioned in the disposable to receive body fluid from a wound in the tissue created by the penetrating member and having a volume of no greater than 1 microliter;

a fracturable sterility barrier disposed on an outer surface of the support covering the plurality of openings without contacting the penetrating member;

the support having a plurality of openings, each of an opening associated with a penetrating member, a device configured to move the fracturable sterility barrier covering opening associated with the penetrating member out of the way of the penetrating member before launch of the penetrating member.

4. A tissue penetration device, comprising:

an electronic penetrating member driver;

a disposable;

a plurality of penetrating members on a support and positioned in the disposable, each of a penetrating member coupled to the penetrating member driver when advanced along a path into a tissue target wherein the support has a plurality of openings, each associated with a penetrating member for the penetrating member to exit;

a plurality of analyte sensors each in a sample chamber, each of a sample chamber being associated with a penetrating member, each of a sample chamber being positioned in the disposable to receive body fluid from a wound in the tissue created by the penetrating member and having a volume of no greater than 1 microliter;

the support having a plurality of openings, each of an opening associated with a penetrating member, wherein tips of the penetrating members reside in a fracturable sterility barrier without contacting the sterility barrier; and

a device that breaks a portion of the sterility barrier associated with one of the penetrating members during launch of the penetrating member so that the penetrating member exits the opening without contacting the sterility barrier.