Device for sampling bodily fluids

• US 20060052724A1
• Filed: 04/20/2005
• Published: 03/09/2006
• 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.
• Granted Patent: US 7,645,241 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 5/150358 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 5/15146 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 5/15163 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. Furthermore, multiple lancet assemblies may be provided in a barrel or disk configuration and indexed to the displacing mechanisms for sampling a skin site.

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 and producing a droplet of bodily fluid,

a transport medium sufficiently close to said lancing medium to retain the droplet of bodily fluid therebetween by capillary action,

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 lancing and transport medium to move said droplet of bodily fluid away from said skin site.

2. Apparatus as claimed in claim 1 wherein said lancing and transport mediums are displaceable relative to one another to move said droplet of bodily fluid.

3. Apparatus as claimed in claim 1 wherein said lancing medium is hydrophobic and said transport medium is hydrophilic.

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

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

6. Apparatus as claimed in claim 3 wherein said transport medium is formed from hydrophilic material.

7. Apparatus as claimed in claim 3 wherein said transport medium is coated with hydrophilic material.

8. Apparatus as claimed in claim 2 wherein said transport medium comprises a discrete element displaceable relative to said lancing medium.

9. Apparatus as claimed in claim 8 wherein said lancing medium is circular in cross section and said transport medium discreet element is a half-round element embracing a portion of the circumference around said needle.

10. Apparatus as claimed in claim 8 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.

11. Apparatus as claimed in claim 1 wherein said mechanism displaces said lancing medium and said transport medium away from said skin site.

12. Apparatus as claimed in claim 2 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.

13. Apparatus as claimed in claim 3 wherein said transport medium is coated with polyamide hydrophilic material.

14. Apparatus as claimed in claim 3 wherein said transport medium is formed from polyamide hydrophilic material.

15. 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 and producing a droplet of bodily fluid,

a transport medium sufficiently close to said lancing medium to retain a droplet of bodily fluid there-between 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 and transport means to move said droplet of bodily fluid away from said skin-piercing end.

16. Apparatus as claimed in claim 15 further comprising a test strip positioned away from said skin site and wherein the means for displacing and lancing and transport means moves said droplet to said test strip.

17. A method of sampling bodily fluids comprising the steps of:

making an incision on a skin site to produce a droplet of bodily fluid, positioning said droplet between two elements by capillary action, one of said elements at least having a hydrophobic and the other at least having a hydrophilic surface, and

producing relative displacement between elements to move said droplet therebetween and away from said skin site.

18. A method as claimed in claim 17 wherein one of said elements is a lancing medium making the incision and the other is a transport medium.

19. A method as claimed in claim 17 wherein said lancing medium is hydrophobic and said transport medium is hydrophilic.

20. A method as claimed in claim 17 wherein said lancing and transport mediums are linearly displaceable relative to one another

21. A method as claimed in claim 17 wherein said lancing and transport mediums are pivotally displaceable relative to one another.

22. 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 and producing a droplet of bodily fluid,

an elongated transport medium adjacent said lancing medium, said lancing medium and transport medium having a preferential path there along sufficiently close to retain the droplet of bodily fluid therebetween by capillary action,

whereby a reduced volume droplet of bodily fluid is moved away from said skin piercing end.

23. Apparatus as claimed in claim 22 wherein a raised surface on at least one of said lancing medium and said transport medium defines said preferential path.

24. Apparatus as claimed in claim 23 wherein said raised surface is on said transport medium.

25. Apparatus as claimed in claim 24 wherein said transport medium is annular in form 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 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 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 and producing a droplet of bodily fluid,

a transport medium sufficiently close to said lancing medium to retain a droplet of bodily fluid there-between by capillary action,

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

a device for relatively displacing said lancing and transport means to move said droplet of bodily fluid away from said skin site.

28. Apparatus as claimed in claim 27 wherein said device has a plurality of lancing mediums positioned to displace against a skin site and a transport medium associated with each lancing medium to retain said droplet of bodily fluid, and wherein said apparatus further comprises means for indexing selected lancing and transport mediums to be in line with said relative displacement device to sample said site.

29. Apparatus as claimed in claim 28 wherein said lancing and transport mediums are arranged in a radial array emanating from a central axis.

30. Apparatus as claimed in claim 29 wherein said apparatus has a disk in which said lancing and transport mediums are retained.

31. Apparatus as claimed in claim 30 further comprising at least one test medium positioned adjacent said lancet and transport medium, said displacement device moving said lancet and transport mediums to carry said droplet from the skin site to said test medium.

32. Apparatus as claimed in claim 31 wherein said test medium comprises a plurality of elements adjacent one another, said test mediums being indexable to position a selected test medium adjacent said lancing and transport medium.

33. Apparatus as claimed in claim 32 wherein said test medium is provided on a roll, said roll being indexable to expose a selected portion adjacent said testing and transport medium.

34. Apparatus as claimed in claim 33 wherein said test medium comprises a plurality of elements arranged in a circular array on a disk, said test medium being rotatable to index selected elements to be in line with said transport and lancing medium.

35. Apparatus as claimed in claim 34 wherein said lancing and transport mediums are arranged in a disk in a radial array emanating from a central axis, said lancing and test medium disks, being rotatable, are independent of one another so that said lancing and transport medium can be used to apply droplets on a plurality of test mediums.

36. Apparatus as claimed in claim 35 further comprising a light source arranged to illuminate selected test mediums that have had a droplet applied to them, said light source being aligned with said transport medium and lancet medium to be in line with a selected test medium.

37. Apparatus as claimed in claim 36 wherein said light source remains fixed relative to said relative displacement means so that said test medium and lancet and transport mediums are rotated to be in line with the skin site and said light illuminating source.

38. Apparatus as claimed in claim 36 further comprising a light guide extending from said test medium and a sensor receiving said light for indicating the condition of said sample.