Tissue penetration device

• US 20060195132A1
• 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: Barry Dean Briggs, Dirk Boecher, Dominique Freeman, Don Alden, George Gogue, Jon Hewitt Leonard, Ray Freeman
• Inventors: Alden, Don, Freeman, Dominique, Freeman, Ray, Boecher, Dirk, Briggs, Barry Dean, Gogue, George, Leonard, Jon Hewitt
• Granted Patent: US 7,981,055 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 sampling module includes a module body portion with a lancet channel, a lancet slidably disposed within the lancet channel. A cover sheet is disposed over the lancet and a lancet channel that captures the lancet shaft in the lancet channel, and a sample reservoir for collection of a sample obtained by lancing a patient with the lancet.

Claims

1. A sampling module comprising a module body portion having a lancet channel, a lancet slidably disposed within the lancet channel, a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel, and a sample reservoir for collection of a sample obtained by lancing a patient with the lancet.

2. The sampling module of claim 1, wherein the sharpened distal tip of the lancet exits a distal end of the module body portion at a lancet exit port and the sample reservoir is in fluid communication with the lancet exit port.

3. The sampling module of claim 2, further comprising a sample input cavity in a distal end surface of the module body portion that a transverse dimension that 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 cavity.

4. The sampling module of claim 1, wherein the sample reservoir comprises a analytical region having sample sensors disposed within the analytical region.

5. The sampling module of claim 4, further comprising sensor contacts in electrical communication with the sample sensors disposed within the analytical region.

6. The sampling module of claim 1, wherein a sharpened distal tip of the lancet is covered by the module body portion when the lancet is in a retracted position and the sharpened distal tip extending beyond a distal end of the lancet module when the lancet is in an extended position.

7. The sampling module of claim 1, wherein the module body portion is comprised of a polymer.

8. The sampling module of claim 1, wherein the module body portion has a length of about 13 mm to about 51 mm and a major transverse dimension of about 2.5 to about 13 mm.

9. The sampling module of claim 1, wherein the module body portion is comprised of PMMA.

10. The sampling module of claim 1, wherein the module body portion is substantially rectangular in shape and comprises a recess configured to be engaged by a ratchet drive mechanism.

11. The sampling module of claim 1, wherein the sample reservoir further comprises thermal sensors for detecting the presence of a sample.

12. A sampling module belt comprising a plurality of sampling modules having a module body portion with a lancet channel and a lancet slidably disposed within the lancet channel and a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel with the plurality of sampling modules interconnected in a linear array by a flexible belt member.

13. The sampling module belt of claim 12, wherein the flexible belt member comprises the cover sheet that extends across at least a portion of the front surface of the module body portions.

14. The sampling module belt of claim 12, wherein the belt member comprises a single sheet of cover sheet material.

15. A sampling module cartridge comprising a plurality of sampling modules interconnected in an array and configured for sequential use.

16. The sampling module cartridge of claim 15, wherein at least one of the sampling modules comprises a sample reservoir having an analytical site with sample sensors for sample testing.

17. A sampling module cartridge comprising:

(a) a plurality of sampling modules interconnected in an array by a flexible member; and

(b) a supply canister that is disposed about an unused portion of the sampling module belt.

18. The sampling module cartridge of claim 17, further comprising a receptacle canister that is configured to store a used portion of the sampling module belt.

19. The sampling module cartridge of claim 17, wherein at least one of the sampling modules comprises a sample reservoir having an analytical site with sample sensors for sample testing.

20. A sampling module cartridge comprising:

(a) a sampling module belt comprising a plurality of sampling modules having a module body portion with a lancet channel, a lancet slidably disposed within the lancet channel, a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel, and a sample reservoir for collection of a sample obtained by lancing a patient with the lancet with the plurality of sampling modules interconnected in a linear array by a flexible belt member;

(b) a supply canister that is disposed about an unused portion of the sampling module belt; and

(c) a receptacle canister that is configured to store a used portion of the sampling module belt.

21. A sampling module cartridge comprising a plurality of sampling modules disposed within a cartridge housing and configured for serial use by a lancet driver.

22. The sampling module cartridge of claim 21, wherein at least one of the sampling modules comprises a sample reservoir having an analytical site with sample sensors for sample testing.

23. The sampling module cartridge of claim 21, wherein the plurality of sampling modules comprise a sampling module belt comprising a plurality of sampling modules having a module body portion with a lancet channel and a lancet slidably disposed within the lancet channel and a cover sheet disposed over the lancet and lancet channel capturing the lancet shaft in the lancet channel with the plurality of sampling modules interconnected in a linear array by a belt member.

24. A cartridge for use in sampling , comprising a sampling cartridge body having a plurality of sampling module portions, a lancet cartridge body having a plurality of lancet module portions with the sampling cartridge body and lancet cartridge body being disposed adjacent each other in an operative configuration such that each lancet module portion can be readily aligned in a functional arrangement with each sampling module portion.

25. The cartridge of claim 24, wherein each sampling module portion comprises a sample reservoir, a lancet channel and an input port wherein the lancet channel is disposed between and in fluid communication with the input port and the sample reservoir and may serve as a sample flow channel.

26. The cartridge of claim 24, wherein each lancet module portion comprises a lancet channel with a lancet slidably disposed in the lancet channel.

27. The cartridge of claim 24, wherein each sampling module portion comprises a separate sampling module connected to adjacent sampling module portions by a flexible belt.

28. The cartridge of claim 24, wherein the lancet module portions comprise separate lancet modules connected to adjacent lancet modules by a flexible belt.

29. The cartridge of claim 24, wherein the lancet cartridge body is removably connected to the sampling cartridge body.

30. The cartridge of claim 24, wherein the sampling module portions may be readily aligned in a functional arrangement with the lancet module portions with single degree of freedom motion between the sampling cartridge body and lancet cartridge body.

31. The cartridge of claim 24, further comprising a cartridge housing with the lancet cartridge body and sampling cartridge body being disposed within the cartridge housing and being separately removable from the cartridge housing.

32. The cartridge of claim 24, wherein the sampling cartridge body comprises a solid body with each sampling module portion disposed in fixed relation to the other sampling module portions in the solid body.

33. The cartridge of claim 24, wherein the lancet cartridge body comprises a solid body with each lancet module portion disposed in fixed relation to the other lancet module portions in the solid body.

34. The cartridge of claim 33, wherein the lancet cartridge body is substantially cylindrical in configuration having a longitudinal axis and each lancet module portion comprises a lancet channel that is substantially aligned in parallel with the longitudinal axis of the cartridge body.

35. The cartridge of claim 24, wherein each sampling module portion comprises a sample reservoir having sample sensors for testing a sample disposed therein.

36. The cartridge of claim 35, wherein the sample sensors are in electrical communication with sensor contacts that are configured to make contact with sensor contact brushes of an analytical reader device.

37. The cartridge of claim 24, wherein each sampling module portion comprises a sample reservoir having sample sensors for detecting the presence of a sample disposed therein.

38. The cartridge of claim 24, wherein the sampling module portions comprise sample reservoirs to accept fluid samples.

39. The cartridge of claim 38, wherein the sample reservoirs comprise an optically transmissive cover sheet disposed over the sample reservoirs.

40. The cartridge of claim 39, further comprising an optical sensor configured to transmit an optical signal through the cover sheet disposed over sample reservoirs of the sampling module portions and receive an optical signal from a sample disposed within the sample reservoirs.

41. The cartridge of claim 24, wherein the sampling cartridge body comprises a solid body having a disk-like configuration with each sampling module portion disposed in fixed relation to the other sampling module portions at a fixed radial distance from a longitudinal axis of the sampling cartridge body.

42. The cartridge of claim 41, wherein each sampling module portion further comprises a lancet channel that is substantially aligned in parallel with a longitudinal axis of the sampling cartridge body.

43. The cartridge of claim 42, wherein the lancet channel of the sampling module portions and lancet channels of the lancet module portions of the lancet cartridge body are disposed at the same radial distance from a longitudinal axis of the cartridge so as to be alignable with relative rotational movement between the sampling cartridge body and lancet cartridge body.