Tissue penetration device

• US 20060195131A1
• Filed: 12/22/2005
• Published: 08/31/2006
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Boecker, Dirk, Alden, Don, Freeman, Dominique, Freeman, Ray, Briggs, Barry Dean, Gogue, George, Leonard, Jon Hewitt
• Granted Patent: US 7,850,622 B2
• 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 moving coil tissue penetration device includes a magnetic source that produces a magnetic field in a magnetically active region. A cylindrical coil is secured to a translation substrate and disposed at least partially within the magnetically active region. A sharpened member is configured to penetrate tissue and mechanically coupled to the translation substrate.

Claims

1. A moving coil tissue penetration device, comprising:

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

b) a cylindrical coil secured to a translation substrate and disposed at least partially within the magnetically active region; and

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

2. The tissue penetration device of claim 1, further comprising a feedback loop having processor which is electrically coupled to an elongate electrical conductor of the cylindrical wire coil and configured to control the magnitude of the force on the translation substrate based on feedback from the position sensor.

3. The tissue penetration device of claim 2, 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.

4. A lancing device for obtaining a blood sample from a patient, comprising:

a) a driver coil pack comprising a proximal end, a distal end, an axial lumen, an inner coil with increased wraps per inch in a distal direction and an outer coil which longitudinally overlaps the inner coil and which has increased wraps per inch in a proximal direction;

b) a magnetic member disposed at least partially within the axial lumen; and

c) a lancet coupled to the magnetic member.

5. A lancing system comprising

a controllable driver having a proximal end and a distal end with a distal end of a coupler shaft disposed at the distal end of the controllable driver;

a ratchet drive mechanism operably disposed at the distal end of the controllable driver; and

a plurality of lancets configured to be sequentially advanced by the ratchet drive mechanism into a coupled configuration with the coupler shaft of the controllable driver.

6. The system of claim 5, wherein the plurality of lancets are disposed within a lancet belt.

7. The system of claim 5, wherein the plurality of lancets are disposed within a lancet module belt.

8. The system of claim 5, wherein the plurality of lancets are disposed within a sampling module belt comprising a plurality of sampling modules interconnected by a flexible belt member.

9. The system of claim 5, wherein the plurality of lancets further comprise a drive head secured to a proximal end of each lancet and configured to be engaged by a drive coupler secured to a distal end of the coupler shaft.

10. The system of claim 9, wherein the drive heads are substantially cylindrical in shape and the drive coupler comprises a T-slot drive coupler.

11. The system of claim 8, wherein the sampling modules of the sampling module belt further comprise an analytical site and sensor contacts and the ratchet drive mechanism further comprises a reader module with contact brushes configured to make electrical contact with the sensor contacts.

12. The system of claim 6, wherein the lancet belt is disposed within a lancet belt cartridge having a supply canister for storage of the unused lancets of the lancet belt and a receptacle canister for acceptance and storage of the used lancets of the lancet belt.

13. The system of claim 7, wherein the lancet module belt is disposed within a lancet module cartridge having supply canister for the unused lancet modules and a receptacle canister for acceptance and storage of used lancet modules.

14. The system of claim 8, wherein the sampling module belt is disposed within a sampling module cartridge having supply canister for the unused sampling modules and a receptacle canister for acceptance and storage of used sampling modules.

15. The system of claim 12, wherein the ratchet drive mechanism comprises:

(a) lancet guide wheel configured to laterally advance a lancet to be used into a coupled arrangement with a drive coupler disposed on a distal end of the elongate coupler shaft;

(b) first and second cog rollers configured to pull tension on a first and second belt tape of the lancet belt and separate the first and second belt tapes away from the lancet to be used; and

(c) an actuation lever mechanically coupled to the lancet guide wheel and first and second cog rollers and configured to advance the lancet guide wheel and first and second cog rollers in a synchronized manner so that as a lancet to be used is freed from the first and second belt tapes the freed lancet is then picked up and advanced into the drive coupler by the lancet guide wheel.

16. The system of claim 15, further comprising a first and second take-up roller configured to take up slack portions of the first and second belt tapes.