Tissue penetration device

• US 20060195133A1
• Filed: 12/22/2005
• Published: 08/31/2006
• Est. Priority Date: 06/12/2001
• Status: Abandoned Application

• Current Assignee: Pelikan Technologies, Inc.
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Freeman, Dominique, Alden, Don, Freeman, Ray, Briggs, Barry Dean, Gogue, George, Leonard, Jon Hewitt
• Application Number:
  US11/318,334
• Publication Number:
  US 20060195133A1
• Time in Patent Office: Days
• US Class Current: 606/181
• 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 tissue penetration device includes a magnetic source that produces a controllable magnetic field in a magnetically active region adjacent the magnetic source. A magnetic member is disposed at least partially in the magnetically active region. A permanent magnet is disposed at a proximal end of the magnetically active region for zeroing the position of the magnetic member while the tissue penetration device is inactive.

Claims

1. A tissue penetration device, comprising:

a) a magnetic source that produces a controllable magnetic field in a magnetically active region adjacent the magnetic source;

b) a magnetic member disposed at least partially in the magnetically active region;

c) a permanent magnet disposed at a proximal end of the magnetically active region for zeroing the position of the magnetic member while the tissue penetration device is inactive.

2. The tissue penetration device of claim 1, wherein the permanent magnet comprises a bar magnet.

3. The tissue penetration device of claim 1, wherein the magnetic source comprises at least one coiled electrical conductor and the permanent magnet comprises a cylindrical magnet having an aperture disposed about the proximal end of the magnetically active region.

4. The tissue penetration device of claim 3, wherein the permanent magnet is spaced proximally from a proximal end of the at least one coiled electrical conductor.

5. A controllable electromagnetic driver for driving a lancet and obtaining a sample of blood from a patient, comprising:

a) a driver coil pack having a proximal end and a distal end comprising a plurality of adjacent electric coils with each coil being comprised of an electrical conductor wound about an axial lumen of each coil with the axial lumens of the coils in a coaxial configuration;

b) an elongate coupler shaft having a proximal end and a distal end disposed within an axial lumen of the driver coil pack;

c) a magnetic member secured to a distal portion of the elongate coupler shaft and configured to slide axially within the axial lumen of the driver coil pack;

d) a position sensor disposed at adjacent the driver coil pack, comprising an optical reader and an optical flag secured to a proximal section of the coupler shaft with the optical flag configured to slide axially adjacent the optical reader and to measure the position of the coupler shaft relative to the position sensor and driver coil pack;

e) a processor which is electrically coupled to the electrical conductors of the plurality of adjacent electric coils and position sensor and which is configured to control a magnitude of a magnetic field in the axial lumen of the driver coil pack by controlling the amount of electrical current flowing through the electrical conductor of each coil based on closed loop feedback position data from the position sensor; and

f) a lancet coupler secured to the distal end of the coupler shaft and configured to be coupled to a lancet.

7. The tissue penetration device of claim 5, wherein the translation substrate is configured to pivot about an axis.

8. The tissue penetration device of claim 5, wherein the translation substrate is configured to move linearly.

9. The flat coil tissue penetration device of claim 5, further comprising a feedback loop having processor which is electrically coupled to elongate electrical conductors of the flat coil and configured to control the magnitude of the force on the translation substrate based on feedback from a position sensor that provides position data of the translation substrate to the processor.

10. The tissue penetration device of claim 9, wherein the processor is configured to control the magnetic force on the translation substrate so as to have the translation substrate and tissue sharpened member follow a predetermined tissue penetration profile.

6. A flat coil tissue penetration device, comprising:

a) a magnetic source that produces a first magnetic field in a first magnetically active region and a second magnetic field in a second magnetically active region;

b) a flat coil secured to a translation substrate and having a leading segment disposed at least partially within the first magnetically active region and. a trailing segment disposed at least partially within the second magnetically active region; and

c) a sharpened member configured to penetrate tissue and mechanically coupled to the translation substrate.