Device for sampling bodily fluids

• US 7,604,604 B2
• Filed: 09/09/2004
• Issued: 10/20/2009
• Est. Priority Date: 09/09/2004
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Roe, Steven N.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Hoekstra; Jeffrey G
• Application Number:
  US10/937,169
• Publication Number:
  US 20060052723A1
• Time in Patent Office: 1,867 Days
• Field of Search: 600/583, 600/573, 600/576, 600/578, 600/579, 600/580, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 10/0045 Devices for taking samples of body liquids devices for taking blood samples A61B5/15
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• CPC Class Codes: A61B 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• 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 5/150412 Pointed piercing elements, e.g. needles, lancets for piercing the skin blade-like piercing elements A61B5/150442
• 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 5/15107 Piercing being assisted by a triggering mechanism
• 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 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15163 Characterized by propelling the piercing element in an axial direction relative to the disc

Abstract

A bodily fluid sampling device comprising a lancet which can be advanced against a skin-piercing site to produce a droplet of bodily fluid. A transport medium is positioned sufficiently close to the lancing medium to retain a droplet of bodily fluid therebetween by capillary action. One of the two mediums has hydrophobic material on its surface and the other hydrophilic. Various mechanisms are provided for relatively displacing the lancing and transport medium to move the droplet of bodily fluid away from the skin-piercing end.

Claims

1. Apparatus for sampling bodily fluids comprising:

an elongated lancing medium having a skin piercing end adapted to be displaced against a skin site for making an incision,

a transport medium separated from said lancing medium and adapted to retain a droplet of bodily fluid from the incision between said transport medium and said elongated lancing medium by capillary action, the retained droplet being held relatively stationary with respect to the transport medium,

one of said lancing and transport mediums having hydrophobic material on its surface and the other having hydrophilic material on its surface, and

a mechanism for displacing said transport medium relative to said lancing medium, said mechanism adapted to move the droplet of bodily fluid retained by said transport medium away from said skin site.

2. Apparatus as claimed in claim 1 wherein said lancing medium has a hydrophobic surface and said transport medium has a hydrophilic surface.

3. Apparatus as claimed in claim 2 wherein said lancing medium has a metallic surface.

4. Apparatus as claimed in claim 3 wherein said lancing medium is a metallic body.

5. Apparatus as claimed in claim 2 wherein said transport medium is formed from hydrophilic material.

6. Apparatus as claimed in claim 2 wherein said transport medium is coated with hydrophilic material.

7. Apparatus as claimed in claim 2 wherein said transport medium is coated with polyamide hydrophilic material.

8. Apparatus as claimed in claim 2 wherein said transport medium is formed from polyamide hydrophilic material.

9. Apparatus as claimed in claim 1 wherein said transport medium comprises a discrete element displaceable relative to said lancing medium.

10. Apparatus as claimed in claim 9 wherein said lancing medium is circular in cross section and said transport medium discreet element is a semicircular element embracing a portion of the circumference around said lancing medium.

11. Apparatus as claimed in claim 9 wherein said lancing medium comprises a needle with a circular cross section and said transport medium discreet element comprises an element having an opening there through embracing the circumference of said needle and through which said needle extends.

12. Apparatus as claimed in claim 1 wherein said mechanism is further adapted to displace said lancing medium relative to said skin site.

13. Apparatus as claimed in claim 1 wherein said transport medium is elongated, said transport medium being pivotal relative to said lancing medium, said pivot point being positioned away from the skin-piercing end of said lancing medium.

14. Apparatus as claimed in claim 1 further comprising a test strip for analyzing bodily fluid from the incision and means for transporting the droplet of bodily fluid retained by said transport medium to said test strip, said means for transporting including said transport medium.

15. Apparatus of claim 14 wherein said mechanism for displacing said transport medium moves the droplet of bodily fluid to the test strip while being retained between said transport medium and said elongated lancing medium.

16. Apparatus as claimed in claim 1 wherein said transport medium is adapted to retain the droplet of bodily fluid with a volume equal to less than one microliter.

17. Apparatus as claimed in claim 1 wherein said transport medium is adapted to retain the droplet of bodily fluid with a volume equal to at least 0.3 microliters and at most 0.7 microliters.

18. Apparatus of claim 1 wherein said mechanism for displacing said transport medium is adapted to move the droplet of bodily fluid retained by said transport medium along said elongated lancing medium.

19. A device for sampling bodily fluids comprising:

an elongated lancing medium having a skin-piercing end adapted to be displaced against a skin site for making an incision,

a transport medium spaced from said lancing medium and adapted to retain a droplet of bodily fluid from the incision therebetween by capillary action,

one of said lancing and transport mediums having hydrophilic material on its surface and the other having hydrophobic material on its surface, and

means for relatively displacing said lancing medium and said transport medium, said means adapted to move the droplet of bodily fluid retained by said transport medium away from said skin-piercing end and along said elongated lancing medium as the transport medium is displaced away from said skin-piercing end.

20. Device as claimed in claim 19 further comprising a test strip positioned away from said skin site, and wherein the means for displacing is adapted to move the droplet of bodily fluid retained by said transport medium to said test strip.

21. Apparatus as claimed in claim 19 wherein said transport medium is adapted to retain the droplet of bodily fluid with a volume equal to less than one microliter.

22. Apparatus as claimed in claim 19 wherein said transport medium is adapted to retain the droplet of bodily fluid with a volume equal to at least 0.3 microliters and at most 0.7 microliters.

23. Apparatus for sampling bodily fluids comprising:

an elongated lancing medium having a length and a skin piercing end, said skin piercing end adapted to be displaced against a skin site for making an incision,

an elongated transport medium with a fluid retaining member adapted to contact bodily fluid from the incision, said fluid retaining member positioned adjacent said lancing medium and spaced to suspend bodily fluid from the incision between said fluid retaining member and said lancing medium by capillary action, and

wherein said elongated transport medium is adapted to separate a droplet of bodily fluid suspended between said fluid retaining member and said lancing medium from said skin piercing end, said droplet having a volume of no more than 1.0 microliters.

24. Apparatus as claimed in claim 23 wherein said fluid retaining member is a raised surface.

25. Apparatus as claimed in claim 24 wherein said transport medium is annular in form at least partially surrounding said lancing medium and said raised surface is in the form of a spiral facing said inward lancing medium.

26. Apparatus as claimed in claim 24 wherein said transport medium is annular in form at least partially surrounding said lancing medium and said raised surface is an elongated rib on said annular transport medium facing inward toward said lancing medium.

27. Apparatus as claimed in claim 23 further comprising means for transporting the droplet of bodily fluid suspended between said fluid retaining member and said lancing medium away from the incision, said means for transporting including said elongated transport medium.

28. Apparatus as claimed in claim 23 wherein said fluid retaining member has a length and said lancing medium has a length, wherein said fluid retaining member length is substantially less than said lancing medium length.

29. Apparatus as claimed in claim 23 wherein each of said elongated lancing medium and said fluid retaining member has a surface, and wherein one of said surfaces is hydrophobic and the other surface is hydrophilic.

30. Apparatus as claimed in claim 23 wherein said elongated transport medium is adapted to separate a droplet of bodily fluid suspended between said fluid retaining member and said lancing medium from said skin piercing end, said droplet having a volume of no more than 0.7 microliters.

31. Apparatus as claimed in claim 23 wherein said elongated transport medium is adapted to hold the droplet of bodily fluid relatively stationary with respect to said elongated transport medium as the droplet is separated from said skin piercing end.

32. Apparatus as claimed in claim 23 further comprising a test medium attached to said lancing medium and said transport medium, said test medium adapted to determine the concentration of an analyte in a droplet of bodily fluid, wherein the elongated transport medium is adapted to move the droplet of bodily fluid to the test medium while being retained between said fluid retaining member and said lancing medium.

33. An apparatus for sampling bodily fluids comprising:

an elongated lancing medium having a skin-piercing end adapted to be displaced against a skin site for making an incision,

a transport medium spaced from said lancing medium adapted to retain a droplet of bodily fluid from the incision therebetween by capillary action,

one of said lancing and transport mediums having hydrophilic material on its surface and the other having hydrophobic material on its surface, and

means for independently actuating said lancing medium and said transport medium, said means adapted to move said droplet of bodily fluid retained by said transport medium away from said skin-piercing end as said transport medium moves away from said skin-piercing end.

34. Apparatus as claimed in claim 33 wherein said lancing medium has a hydrophobic surface and said transport medium has a hydrophilic surface.

35. Apparatus as claimed in claim 33 wherein said transport medium is adapted to retain the droplet of bodily fluid with a volume equal to less than one microliter.

36. Apparatus as claimed in claim 35 wherein said transport medium is adapted to retain the droplet of bodily fluid with a volume equal to at least 0.3 microliters and at most 0.7 microliters.

37. Apparatus as claimed in claim 33 wherein said means is further adapted to separate the droplet of bodily fluid retained by said transport medium from said skin-piercing end.

38. Apparatus for sampling bodily fluids comprising:

an elongated lancing medium having a skin piercing end, said skin piercing end adapted to be displaced against a skin site for making an incision,

a fluid retaining member separated from said lancing medium to define a gap between said fluid retaining member and said elongated lancing medium, wherein said fluid retaining member and said lancing medium are adapted to retain bodily fluid from the incision in the gap by capillary action,

a test medium attached to said lancing medium and said transport medium, said test medium adapted to determine the concentration of an analyte in a droplet of bodily fluid, and

a mechanism for independently activating said lancing medium and said transport medium, said mechanism adapted to move a droplet of bodily fluid away from said skin site and to said test medium while being retained between said fluid retaining member and said elongated lancing medium.

39. Apparatus as claimed in claim 38 wherein said lancing medium surface is hydrophobic and said transport medium surface is hydrophilic.

40. Apparatus as claimed in claim 38 wherein said transport medium is adapted to retain the droplet of bodily fluid with a volume equal to less than one microliter.

41. Apparatus as claimed in claim 38 wherein said transport medium is adapted to retain the droplet of bodily fluid with a volume equal to at least 0.3 microliters and at most 0.7 microliters.

42. Apparatus as claimed in claim 38 wherein said elongated lancing medium has a length, and wherein said fluid retaining member has a length less than said lancing medium length.

43. Apparatus as claimed in claim 38 wherein said fluid retaining member is adapted to retain the droplet of bodily fluid relatively stationary with respect to said fluid retaining member as the droplet is moved away from the skin site.

44. Apparatus for sampling bodily fluid from the skin comprising:

a lancet for forming an incision in the skin;

a test strip for analyzing bodily fluid from the incision;

a sheath adjacent the lancet with a semicircular disk extending toward the lancet, the semicircular disk including

a fluid retention surface facing the lancet, the fluid retention surface adapted to retain a drop of bodily fluid adjacent the fluid retention surface and between the fluid retention surface and the lancet by capillary action, and

a side surface adjacent the fluid retention surface, the side surface adapted to inhibit retention of bodily fluid by capillary action between the side surface and the lancet; and

a sheath actuator configured to displace the fluid retention surface from

a first position adjacent the skin surface, the fluid retention surface being configured in the first position to capture the discrete drop of bodily fluid from the incision between the lancet and the fluid retention surface,

to a second position adjacent the test strip, the fluid retention surface being configured in the second position to retain the drop of fluid away from the incision and place the drop of retained fluid in contact with the test strip.

45. Apparatus as claimed in claim 44 wherein said fluid retention surface is adapted to retain the droplet of bodily fluid with a volume equal to less than one microliter.

46. Apparatus as claimed in claim 44 wherein said fluid retention surface is adapted to retain the droplet of bodily fluid with a volume equal to at least 0.3 microliters and at most 0.7 microliters.

47. Apparatus as claimed in claim 44 wherein said fluid retention surface is formed from hydrophilic material.

48. Apparatus as claimed in claim 44 wherein sheath actuator is configured to move the drop of bodily fluid to the test strip while the fluid retention surface retains the drop between the fluid retention surface and the lancet.

49. Apparatus as claimed in claim 44 wherein the fluid retention surface is adapted to retain the drop of bodily fluid relatively stationary with respect to the fluid retention surface as the fluid retention surface is displaced from the first position to the second position.