Tissue penetration device

• US 20090137930A1
• Filed: 12/16/2008
• Published: 05/28/2009
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Alden, Don, Freeman, Dominique
• Granted Patent: US 9,937,298 B2
• Time in Patent Office: Days
• 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 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 for generating a piercing wound in a skin surface to obtain body fluid, comprising:

a penetrating member guide configured to hold a penetrating member;

a penetrating member drive for generating a drive force to move the penetrating member guide along a piercing path in a piercing direction;

a retention mechanism for generating a magnetic retention force for retaining the penetrating member guide in a tensioned position;

a trigger configured to provide on actuation a reduction in a force to provide that a drive force accelerates the penetrating member guide in a piercing direction; and

a control device which controls the reduction in retention force and regulates piercing depth of the penetrating member.

2. The tissue penetration device of claim 1, wherein the penetrating member guide advances freely in the piercing direction up to an oscillation reversal point, wherein piercing depth is not affected by a mechanical piercing depth stop.

3. The tissue penetration device of claim 1, wherein the penetrating member drive includes a plate positioned on the penetrating member guide, the plate being formed from magnetic material.

4. The tissue penetration device of claim 1, further comprising:

an electromagnetic actuator driven by the control device, the electromagnetic actuator regulating at least one of, piercing depth by adjustable thrust and adjustable braking.

5. The tissue penetration device of claim 4, wherein the electromagnetic actuator generates a magnetic field which counters the retention force.

6. The tissue penetration device of claim 5 wherein the control device is configured to drive the actuator to accelerate the penetrating member guide in a retraction movement opposite the piercing movement after performing a piercing such that the penetrating member guide returns to a tensioned position in which it is retained by the magnetic retention force.

7. A method for operating a tissue penetration device having a penetrating member guide that holds a penetrating member and a penetrating member drive for generating a drive force to move the penetrating member guide along a piercing path in a piercing direction, the method comprising:

positioning the penetrating member drive in a tensioned position;

retaining the penetrating member drive in the tensioned position with a magnetic force;

selecting a desired piercing depth; and

selectively varying the magnetic force to release the penetrating member drive from the tensioned position and to cause the penetrating member to advance to and reverse direction at the desired piercing depth.

8. The method of claim 7, wherein the step of selectively varying the magnetic force includes reducing the magnetic force, wherein a force acting on the penetrating member by the penetrating member drive overcomes the magnetic force, the force acting on the penetrating member advancing the penetrating member in the piercing direction.

9. The method of claim 8, wherein the step of selectively varying the magnetic force comprises repelling the penetrating member in the piercing direction.

10. The method of claim 7, wherein the step of selectively varying the magnetic force includes selecting a speed at which to reduce the magnetic force.

11. The method of claim 7, wherein the step of selectively varying the magnetic force includes accelerating the penetrating member in a retraction movement opposite the piercing movement to return the penetrating member drive to the tensioned position.

12. A tissue penetration device for generating a piercing wound in a skin surface, comprising:

a penetrating member guide configured to hold a penetrating member;

a penetrating member drive for generating a drive force to move the penetrating member guide along a piercing path in a piercing direction;

a magnet associated with the penetrating member drive;

an electromagnet releasably coupled to the magnet when the penetrating member drive is in a tensioned position; and

a control device operably connected to the electromagnet, the control device configured to selectively vary a magnetic force between the electromagnet and the magnet as a function of desired piercing depth, wherein the penetrating member guide advances freely in a piercing direction up to an oscillation reversal point.

13. The tissue penetration device of claim 12, wherein the magnet is attached to the penetrating member guide.

14. The tissue penetration device of claim 13, wherein the magnet includes a plate formed from magnetic material.

15. The tissue penetration device of claim 12, wherein, after a piercing movement of the penetrating member guide, the control device varies the magnetic force to accelerate the penetrating member guide in a retraction movement opposite the piercing movement to return the penetrating member drive to the tensioned position.