Tissue penetration device

• US 8,360,991 B2
• Filed: 12/23/2005
• Issued: 01/29/2013
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique, Boecker, Dirk, Alden, Don, Briggs, Barry Dean, Leonard, Jon Hewitt, Freeman, Ray, Gogue, George
• Primary Examiner(s): NGUYEN, VI X
• Application Number:
  US11/317,913
• Publication Number:
  US 20060195130A1
• Time in Patent Office: 2,594 Days
• Field of Search: 606181-186, 600/573, 600/582, 600/583, 600/575, 128/898
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150061 Means for enhancing collection
• CPC Class Codes: A61B 5/150068 by tissue compression, e.g. with specially designed surface of device contacting the skin area to be pierced
• CPC Class Codes: A61B 5/150099 by negative pressure, other than vacuum extraction into a syringe by pulling on the piston rod or into pre-evacuated tubes
• 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 5/15019 Depth adjustment mechanism using movable stops located inside the piercing device housing and limiting the travel of the drive mechanism mechanisms using distal end caps A61B5/150183, mechanisms at the piercing element carrier proximal end A61B5/150198
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/15113 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 5/15146 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 5/15163 : 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 5/15176 : Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• 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: A61M 5/158 : Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61M 5/46 : having means for controlling depth of insertion
• 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: B01L 3/50273 : characterised by the means or forces applied to move the fluids micropumps F04B19/006, of the membrane type F04B43/043
• CPC Class Codes: B01L 3/502746 : characterised by the means for controlling flow resistance, e.g. flow controllers, baffles B01L3/502738 takes precedence
• 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

A method of lancing the tissue of a patient provides a tissue penetration element with a tip configured to penetrate tissue and a shaft portion. The tissue penetration element is disposed in proximity to the tissue of the patient. The tissue penetration element is driven distally towards the tissue of the patient. Contact is made between the tip and the tissue of the patient. The tip is advanced into the tissue during a penetration stroke to a position of maximum inward displacement. The tissue penetration element is allowed to settle upon reaching the point of maximum inward penetration for at least about 1 millisecond with no driving force imposed on the tissue penetration element. The tissue penetration element is displaced proximally over a withdrawal stroke and the tip is removed from the tissue.

Claims

1. A method of lancing the tissue of a patient comprising:

(a) providing an electromagnetic driver having a tissue penetration element having a tip configured to penetrate tissue and a shaft portion;

(b) disposing the tissue penetration element in proximity to the tissue of the patient;

(c) driving the tissue penetration element distally towards the tissue of the patient;

(d) determining contact between the tip and the tissue of the patient;

(e) advancing the tip into the tissue during a penetration stroke to a position of maximum inward displacement that is determined electronically via a position sensor;

(f) monitoring motion of the tissue penetration element and allowing the tissue penetration element to settle upon reaching the point of maximum inward penetration for at least about 1 millisecond with no driving force imposed on the tissue penetration element until any motion of the tissue penetration element has stopped; and

(g) displacing the tissue penetration element proximally over a withdrawal stroke and removing the tip from the tissue, the allowing the tissue penetration element to settle upon reaching the point of maximum inward penetration for at least about 1 millisecond and displacing the tissue penetration element creating a spontaneous flow of a blood sample without milking.

2. The method of claim 1, further comprising allowing the tissue penetration element to settle upon reaching the point of maximum inward penetration for about 50 to about 2000 milliseconds, wherein no driving force is imposed on the tissue penetration element while settling.

3. The method of claim 1, wherein the average velocity of the tissue penetration element during the penetration stroke from the point of contact with the tissue until the position of maximum inward displacement is about 2 to about 8 meters per second.

4. The method of claim 1, wherein the average velocity of the tissue penetration element during the withdrawal stroke from the position of maximum inward displacement is about 2 to about 10 meters per second.

5. A method of lancing the tissue of a patient comprising:

(a) providing an electromagnetic driver having a tissue penetration element having a tip configured to penetrate tissue and a shaft portion;

(b) disposing the tissue penetration element in proximity to the tissue of the patient;

(c) driving the tissue penetration element distally towards the tissue of the patient;

(d) determining contact between the tip and the tissue of the patient;

(e) advancing the tip into the tissue during a penetration stroke to a position of maximum inward displacement that is determined electronically via a position sensor;

(f) determining and applying right amount of driving force to the tissue penetration element necessary to hold the tissue penetration element substantially stationary and prevent retrograde motion of the tissue penetration element at the point of maximum inward penetration for at least about 1 millisecond; and

(g) displacing the tissue penetration element proximally over a withdrawal stroke and removing the tip from the tissue, the hold the tissue penetration element substantially stationary and prevent retrograde motion of the tissue penetration element the point of maximum inward penetration for at least about 1 millisecond displacing the tissue penetration element creating a spontaneous flow of a blood sample without milking.

6. The method of claim 5, further comprising applying force on the tissue penetration element to hold the tissue penetration element stationary upon reaching the point of maximum inward penetration for about 50 to about 2000 milliseconds.