Sampling module device and method

• US 20030083685A1
• Filed: 04/19/2002
• Published: 05/01/2003
• Est. Priority Date: 06/12/2001
• Status: Active Grant

• Current Assignee: Sanofi-Aventis Deutschland GmbH (Sanofi )
• Original Assignee: Pelikan Technologies, Inc.
• Inventors: Weber, Lutz, Boecker, Dirk, Alden, Don, Freeman, Dominique M., Hartmann, Han Joachim
• Granted Patent: US 7,041,068 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 tissue penetration device and method of using same that may include a lancet module or sampling module. The sampling module may optionally be in a cartridge configuration and include sampling and analyzing functions, which may be integrated.

Claims

1. A lancet module, comprising

a module body portion comprising a lancet channel with a plurality of lancet bearing guides disposed within the lancet channel;

and

a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel and lancet bearing guides with the lancet bearing guides configured to confine a lancet to substantially linear axial movement.

2. The lancet module of claim 1 wherein the module body portion comprises three 3 lancet bearing guides separated spatially along the lancet channel with a lancet bearing guide disposed at either end of the lancet channel.

3. The lancet module of claim 1 wherein a longitudinal axis of the lancet channel is substantially parallel to a longitudinal axis of the module body portion.

4. The lancet module of claim 1 wherein the lancet channel further comprises at least one flow stop chamber disposed within a distal end portion of the lancet channel that has a transverse dimension that is significantly larger than a transverse dimension of a distally adjacent portion of the lancet channel and a rapid transition in transverse dimension that will interrupt capillary action from a distal end of the lancet channel.

5. The lancet module of claim 1 wherein the module body portion is configured to be mechanically registered and secured adjacent a lancet driver.

6. A lancet module, comprising

a module body portion comprising a lancet channel having at least one flow stop chamber disposed within a distal end portion of the lancet channel that has a transverse dimension that is significantly larger than a transverse dimension of a distally adjacent portion of the lancet channel and a rapid transition in transverse dimension that will interrupt capillary action from a distal end of the lancet channel;

and

a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel.

7. The lancet module of claim 6 wherein the lancet channel further comprises at least one lancet bearing guide with the lancet bearing guides configured to confine the lancet to substantially linear axial movement.

8. The lancet module of claim 6 wherein the module body portion comprises three 3 lancet bearing guides separated spatially along the lancet channel with a lancet bearing guide disposed at either end of the lancet channel.

9. The lancet module of claim 6 wherein a longitudinal axis of the lancet channel is substantially parallel to a longitudinal axis of the module body portion.

10. The lancet module of claim 6 wherein the module body portion is configured to be mechanically registered and secured adjacent a lancet driver.

12. The sampling module of claim 10 wherein the module body portion comprises three 3 lancet bearing guides separated spatially along the lancet channel with a lancet bearing guide disposed at either end of the lancet channel.

11. A sampling module, comprising

a module body portion comprising a lancet channel with a plurality of lancet bearing guides disposed within the lancet channel;

a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel and lancet bearing guides with the lancet bearing guides configured to confine a lancet to substantially linear axial movement; and

a sample reservoir in fluid communication with a sample input port of the module body portion.

13. The sampling module of claim 11 wherein a longitudinal axis of the lancet channel is substantially parallel to a longitudinal axis of the module body portion.

14. The sampling module of claim 11 wherein the lancet channel further comprises at least one flow stop chamber disposed within a distal end portion of the lancet channel that has a transverse dimension that is significantly larger than a transverse dimension of a distally adjacent portion of the lancet channel and a rapid transition in transverse dimension that will interrupt capillary action from a distal end of the lancet channel.

15. The sampling module of claim 11 wherein the module body portion is configured to be mechanically registered and secured adjacent a lancet driver.

16. A sampling module, comprising:

a module body portion comprising a lancet channel having at least one flow stop chamber disposed within a distal end portion of the lancet channel that has a transverse dimension that is significantly larger than a transverse dimension of a distally adjacent portion of the lancet channel and a rapid transition in transverse dimension that will interrupt capillary action from a distal end of the lancet channel;

a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel; and

a sample reservoir in fluid communication with a sample input port of the module body portion.

17. The sampling module of claim 16 wherein the lancet channel further comprises at least one lancet bearing guide with the lancet bearing guides configured to confine the lancet to substantially linear axial movement.

18. The sampling module of claim 16 wherein the module body portion comprises three 3 lancet bearing guides separated spatially along the lancet channel with a lancet bearing guide disposed at either end of the lancet channel.

19. The sampling module of claim 16 wherein a longitudinal axis of the lancet channel is substantially parallel to a longitudinal axis of the module body portion.

20. The sampling module of claim 16 wherein the module body portion is configured to be mechanically registered and secured adjacent a lancet driver.

21. A sampling module, comprising:

a module body portion comprising a lancet channel;

a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel of the module body portion;

a sample reservoir having an input end and a terminal end, the sample reservoir being in fluid communication with a sample input port of the module body portion; and

a vent disposed between and in fluid communication with the terminal end of the sample reservoir and the lancet channel.

22. The sampling module of claim 21 wherein a longitudinal axis of the lancet channel is substantially parallel to a longitudinal axis of the module body portion.

23. The sampling module of claim 21 wherein the module body portion is configured to be mechanically registered and secured adjacent a lancet driver.

24. The sampling module of claim 21 wherein the terminal end further comprises a fill detector.

25. The sampling module of claim 24 wherein the fill detector is electrical.

26. The sampling module of claim 24 wherein the fill detector is optical.

27. The sampling module of claim 24 wherein the fill detector is visual.

28. A sampling module comprising:

a module body portion having a sampling site adjacent a lancet exit port where the sharpened distal tip of the lancet exits a distal end of the module body portion that includes a sample cavity in a distal end surface of the module body portion;

a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion and extendable from the lancet exit port; and

a sample reservoir in fluid communication with a sample cavity of the module body portion.

29. The sampling module of claim 28 wherein a transverse dimension of the sampling cavity is about 2 to about 5 times a transverse dimension of the lancet shaft portion and wherein a sample flow channel is disposed between and in fluid communication with the sample reservoir and the sample cavity.

30. The sampling module of claim 28 wherein the module body portion is configured to be mechanically registered and secured adjacent a lancet driver.

31. A sampling module, comprising:

a module body portion configured to be mechanically registered and secured adjacent a lancet driver;

a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the module body portion; and

a sample reservoir in fluid communication with a sample input port of the module body portion that has a fill detector for determining when the sample reservoir is full of a sample.

32. The sampling module of claim 31 wherein the fill detector is electrical.

33. The sampling module of claim 31 wherein the fill detector is optical.

34. The sampling module of claim 31 wherein the fill detector is visual.

35. A sampling module, comprising:

a module body portion comprising a lancet channel;

a lancet comprising a sharpened distal tip and shaft portion which is slidably disposed within the lancet channel of the module body portion;

a first sample reservoir having an input end and a terminal end, the input end of the sample reservoir being in fluid communication with a sample input port of the module body portion; and

a second sample reservoir having an input end in fluid communication with the terminal end of the first sample reservoir and having a cross sectional area that is substantially smaller than a cross sectional area of the first sample reservoir such that a sample flowing from the sample input port into the first sample reservoir will fill the first sample reservoir and then rapidly fill the second sample reservoir by capillary action.

36. The sampling module of claim 35 wherein a terminal end of the second sample reservoir further comprises a fill detector.

37. The sampling module of claim 36 wherein the fill detector is electrical.

38. The sampling module of claim 36 wherein the fill detector is optical.

39. The sampling module of claim 36 wherein the fill detector is visual.