Tissue penetration device

• US 20060241667A1
• Filed: 03/24/2006
• Published: 10/26/2006
• Est. Priority Date: 04/19/2002
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Inventors: Freeman, Dominique
• Granted Patent: US 8,337,420 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 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• 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 5/150099 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 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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: 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: 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 body fluid sampling system is provided for use on a tissue site. A container has at least one guide chamber and a driver. A plurality of penetrating members are included. At least one sample receiving unit is configured to be coupled to the driver and advanced out of the guide chamber of the container and receiving body fluid at a receiving site. A penetrating member is integrated with the sample receiving unit to carry out a lancing movement towards a body part containing the body fluid.

Claims

1. A body fluid sampling system for use on a tissue site, the system comprising:

a container with at least one guide chamber;

a driver;

a plurality of penetrating members, at least one sample receiving unit configured to be coupled to the driver and advanced out of the guide chamber of the container and receiving body fluid at a receiving site, wherein a penetrating member is integrated with the sample receiving unit to carry out a lancing movement towards a body part containing the body fluid.

2. The device of claim 1, wherein the penetrating member is configured to be can be displaced in a guide of the sample receiving unit in its direction of movement.

3. Device according to claim 1, wherein the penetrating member can puncture the body part at a predetermined distance to a free front area of the sample receiving unit.

4. The device of claim 1, wherein the penetrating device can be coupled in a form-fitting manner to the drive by an associated engaging member for a reciprocating lancing movement.

5. The device of claim 1, wherein the drive has a control device to control a sequence of movements of the sample receiving unit and/or the penetrating member.

6. The device of claim 1, wherein the sample receiving unit has an analytical test element to examine the body fluid.

7. The device of claim 1, wherein the sample receiving unit has a capillary active transport channel for the body fluid.

8. The device of claim 7, wherein the transport channel is formed by a ring gap between the penetrating member and a wall area of the sample receiving unit surrounding the penetrating member.

9. The device of claim 7, wherein the transport channel ends on an analytical test field via a lateral outlet in the transport area.

10. The device of claim 7, wherein the transport channel ends at an analytical test sleeve via an axial outlet opening pointing in the direction of the channel.

11. The device of claim 1, wherein the guide chamber is closed by a sealing foil at least in the area of an ejection opening and that the sample receiving unit has a free end area facing the direction of advance to pierce the sealing foil.

12. The device of claim 1, wherein the sample receiving unit is constructed as a test strip.

13. The device of claim 12, wherein the sample receiving unit is constructed as an injection molded test body for examining blood.

14. The device of claim 1, wherein the sample receiving unit is formed by a hollow needle to suck in the sample fluid.

15. The device of claim 14, wherein the hollow needle serves as a guide for the penetrating member.

16. The device of claim 1, wherein the container is a drum with a plurality of guide chambers running axially each for of a sample receiving unit that are distributed in a circumferential direction relative to the drum.

17. The device of claim 1, wherein the container as a disk has a plurality of radial guide chambers each for one sample receiving unit that are arranged radially.

18. The device of claim 1, wherein the device is a transportable hand device for medical diagnostics.

19. The device of claim 1, wherein the body fluid is collected by a puncturing movement of the penetrating member that is moved in the sample receiving unit in an area of the receiving site.