Method and apparatus for penetrating tissue

• US 7,648,469 B2
• Filed: 01/31/2008
• Issued: 01/19/2010
• Est. Priority Date: 04/19/2002
• Status: Expired due to Term

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique M.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): HOEKSTRA, JEFFREY GERBEN
• Application Number:
  US12/023,615
• Publication Number:
  US 20080119761A1
• Time in Patent Office: 719 Days
• Field of Search: 600/583, 600/564, 600/568, 600/573, 600/575, 600/576, 600/577, 600/579, 600/584, 604/318, 604/322, 604/326, 606/181
• US Class Current: 600/583
• CPC Class Codes: A61B 17/32093 for skin incisions
• 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 5/150022 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 5/150427 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 5/150572 Pierceable protectors, e.g. shields, caps, sleeves or films, e.g. for hygienic purposes
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/15123 comprising magnets or solenoids
• 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 5/15153 Multiple piercing elements stocked in a single compartment
• 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 5/15184 : 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 2005/004 : Magazines with multiple needles directly inserted into an injection or infusion device, e.g. revolver-like magazines
• CPC Class Codes: B01L 2200/10 : Integrating sample preparation and analysis in single entity, e.g. lab-on-a-chip concept
• CPC Class Codes: B01L 2300/0663 : Whole sensors
• CPC Class Codes: B01L 2300/18 : Means for temperature control
• CPC Class Codes: B01L 3/5027 : by integrated microfluidic structures, i.e. dimensions of channels and chambers are such that surface tension forces are important, e.g. lab-on-a-chip B01L3/5023 takes precedence; micromixers B01F33/30; microreactors for synthesis B01J19/0093; microcapillary devices in general B81B1/00
• CPC Class Codes: B01L 3/502715 : characterised by interfacing components, e.g. fluidic, electrical, optical or mechanical interfaces
• CPC Class Codes: G01N 33/4905 : Determining clotting time of blood by chemical methods G01N33/86, C12Q1/54
• CPC Class Codes: G01N 33/557 : using kinetic measurement, i.e. time rate of progress of an antigen-antibody interaction

Abstract

These and other objects of the present invention are achieved in a body fluid sampling system for use on a tissue site that includes an electrically powered drive force generator. A penetrating member is operatively coupled to the force generator. The force generator moves the member along a path out of a housing having a penetrating member exit, into the tissue site, stops in the tissue site, and withdraws out of the tissue site. An analyte detecting member is positioned to receive fluid from a wound created by the penetrating member. The detection member is configured to determine a concentration of an analyte in the fluid using a sample of less than 1 μL of the fluid.

Claims

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

an electrically powered drive force generator, wherein the drive force generator is selected from a voice coil drive force generator and a rotary voice coil drive force generator;

a penetrating member operatively coupled to said force generator, said force generator moving said member 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;

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

L of the body fluid;

a programmable processor operatively programmed with software that has control instructions for controlling the drive force generator to provide controlled impact of the penetrating member to and through the tissue site, to provide controlled retraction velocity of the penetrating member from the tissue site, and to provide controlled dwell time of the penetrating member at the tissue site, with the penetrating member being withdrawn from the tissue site at a slower speed than a speed of initial penetration into the tissue site, and to determine a concentration of the analyte in the fluid using less than 1 μ

L of the fluid, wherein the control instructions are selected based on at least one of, penetration depth of the penetrating member and velocity of the penetrating member, the programmable processor providing a tissue dwell time that is related to an amount of skin deformation as the penetrating member tries to puncture a surface of the tissue site.

2. The system of claim 1, further comprising a penetrating position sensor that includes an interference encoder.

3. The system of claim 1, further comprising:

a tissue stabilizer device coupled to the housing.

4. The system of claim 3, wherein the tissue stabilizer device is configured to enhance fluid flow from a target tissue.

5. The system of claim 3, wherein the tissue stabilizer device creates a stretching of a skin surface.

6. The system of claim 3, wherein the tissue stabilizer device includes a plurality of protrusions.

7. The system of claim 3, wherein the tissue stabilizer device creates a vacuum around a target tissue.

8. The system of claim 3, wherein the tissue stabilizer device is configured to apply a force to a target tissue and cause the target tissue to press in an inward direction relative to the housing member.

9. The system of claim 3, wherein the tissue stabilizing device generates a stimulation at a target tissue.

10. The system of claim 1, further comprising:

a seal formed by a fracturable material that seals the penetrating member and positioned at a place of at least one of a distal port or a proximal port.

11. The system of claim 1 further comprising a vacuum source to provide a low pressure environment to draw fluid from a wound created by the penetrating member in the tissue.

12. The system of claim 1, further comprising:

a support structure for receiving the penetrating members.

13. The system of claim 12, wherein the support structure is a drum.