Tissue penetration device

• US 7,025,774 B2
• Filed: 04/19/2002
• Issued: 04/11/2006
• Est. Priority Date: 06/12/2001
• 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., Freeman, Ray, Briggs, Barry Dean, Gogue, George, Leonard, Jon Hewitt
• Primary Examiner(s): Woo, Julian W.
• Assistant Examiner(s): NGUYEN, VI X
• Application Number:
  US10/127,395
• Publication Number:
  US 20030083686A1
• Time in Patent Office: 1,453 Days
• Field of Search: 606/181, 606/182, 606/185, 606/186, 606/156, 606/165, 604/46, 604/197, 604/198, 600/557, 600/573, 600/583, 128/898
• 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 and method of using same. The tissue penetration device may optionally include sampling and analyzing functions, which may be integrated. An embodiment provides control of a lancet used for sampling blood. Electric field coils or solenoids may drive the lancet using electromagnetic force. Advancement and retraction of a lancet may be controlled by a feedback loop monitoring the position and velocity of the lancet embodiments of the lancet driver can be configured to follow a predetermined tissue lancing profile. Embodiments of the invention include a lancet and method for using a lancet to maintain the patency of the wound tract once the lancet has cut into the skin.

Claims

1. A method of lancing the skin of a patient to bring a blood sample to a tissue surface, the method comprising:

(a) providing a tissue penetration element having a tip configured to penetrate tissue;

(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) making 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;

(f) displacing the tissue penetration element proximally over a withdrawal stroke at an average velocity that is substantially lower than an average velocity of the tissue penetration element during the penetration stroke, wherein the average velocity of the tissue penetration element during the penetration stroke is about 100 to about 1000 times greater than the average velocity of the tissue penetration member during the withdrawal stroke; and

(g) withdrawing the tissue penetration element during a withdrawal stroke at a maximum velocity of up to about 0.02 meters per second.

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 1 to about 2000 milliseconds, wherein no driving force is imposed on the tissue penetration element while settling.

3. The method of claim 1 further comprising allowing the tissue penetration element to settle upon reaching the point of maximum inward penetration for about 8 to about 200 milliseconds, wherein no driving force is imposed on the tissue penetration element while settling.

4. 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.

5. 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 200 milliseconds, wherein no driving force is imposed on the tissue penetration element while settling.

6. The method of claim 1 wherein the average velocity of the tissue penetration element during the withdrawal stroke during which the tissue penetration element is moving proximally relative to tissue in contact with the tissue penetration element is about 0.001 to about 0.01 meters per second.

7. 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 4 meters per second and wherein the average velocity of the tissue penetration element during the withdrawal stroke during which the tissue penetration element is moving proximally relative to tissue in contact with the tissue penetration element is about 0.001 to about 0.01 meters per second.

8. The method of claim 1 wherein the tissue comprises the skin of a human patient and the tip penetrates the skin to at the position of maximum inward displacement to a depth of about 0.5 to about 3.0 mm from an outer surface of the skin.

9. The method of claim 1 further comprising selecting a desired lancing velocity profile from a set of alternative lancing velocity profiles having characteristic phases for tissue penetration element advancement and retraction.

10. The method of claim 1 further comprising providing a lancing device having a position feedback loop far monitoring longitudinal displacement of said tissue penetration element and for modulating a controllable driver to provide a predetermined tissue lancing profile having characteristic phases for tissue penetration element advancement and retraction.

11. The method of claim 1 further comprising acquiring tissue data based on an interaction between the tissue penetration element and the tissue during at least a portion of the lancing cycle.

12. The method of claim 1 further comprising withdrawing the tissue penetration element from the skin of the patient at a velocity sufficiently slow to allow blood flowing from severed blood vessels to flow into a channel in the patient tissue created by the tip of the penetration member to follow the tip out of the wound channel and flow to a surface of the tissue.

13. The method of claim 1 wherein an electromagnetic force generating member is used to drive the tissue penetration member.

14. The method of claim 13 further comprising using a permanent magnet disposed at a proximal end of a magnetically active region of the electromagnetic force generating member for zeroing the position of a magnetic member disposed at least partially in the magnetically active region while the tissue penetration device is inactive.

15. The method of claim 13 further comprising using a position sensor disposed adjacent a driver coil pack in the force generating member, said position sensor comprising an optical reader and an optical flag secured to a proximal section of a coupler shaft of the force generating member, 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.

16. The method of claim 1 further comprising using a feedback loop position sensor configured to measure the position and control the velocity of the tissue penetration element.

17. The method of claim 1 further comprising using a feedback loop that includes a light detecting sensor and a light emitter for monitoring the relative position of the tissue penetration element comprising a reflective surface on a proximal end such that the light emitter emits light that is reflected from the reflective surface to the sensor.

18. The method of claim 1 further comprising:

measuring a velocity of a moving tissue penetration element at a known position;

comparing the measured velocity of the tissue penetration element with an appropriate velocity for the tissue penetration element at the known position; and

applying a force to the tissue penetration element to adjust the velocity of the tissue penetration element.

19. The method of claim 1 further comprising:

monitoring position and speed of the tissue penetration element as the tissue penetration element moves in a first direction;

adjusting the application of force to the tissue penetration element as the tissue penetration element moves in the first direction to achieve a desired speed of the tissue penetration element;

adjusting the application of force to the tissue penetration element when the tissue penetration element contacts the tissue so that the tissue penetration element penetrates the tissue within a desired range of speed.

20. The method of claim 1 further comprising:

applying a braking force to the tissue penetration element to decelerate the tissue penetration element as the tissue penetration element moves in the first direction toward the tissue such that the tip of the tissue penetration element penetrates the tissue to a desired depth.

21. A method of lancing the skin of a patient to bring a blood sample to a tissue surface, the method comprising:

(a) providing a tissue penetration element having a tip configured to penetrate tissue;

(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) making 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;

(f) displacing the tissue penetration element proximally over a withdrawal stroke at an average velocity that is substantially lower than an average velocity of the tissue penetration element during the penetration stroke;

(g) withdrawing the tissue penetration element during a withdrawal stroke at a maximum velocity of up to about 0.02 meters per second; and

using a position sensor disposed adjacent a driver coil pack in the force generating member, said position sensor comprising an optical reader and an optical flag secured to a proximal section of a coupler shaft of the force generating member, 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.

22. A method of lancing the skin of a patient to bring a blood sample to a tissue surface, the method comprising:

(a) providing a tissue penetration element having a tip configured to penetrate tissue;

(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) making 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;

(f) displacing the tissue penetration element proximally over a withdrawal stroke at an average velocity that is substantially lower than an average velocity of the tissue penetration element during the penetration stroke;

(g) withdrawing the tissue penetration element during a withdrawal stroke at a maximum velocity of up to about 0.02 meters per second; and

using a feedback loop that includes a light detecting sensor and a light emitter for monitoring the relative position of the tissue penetration element comprising a reflective surface on a proximal end such that the light emitter emits light that is reflected from the reflective surface to the sensor.