Device for sampling bodily fluids

• US 8,419,657 B2
• Filed: 11/23/2009
• Issued: 04/16/2013
• 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 F
• Application Number:
  US12/624,060
• Publication Number:
  US 20100069793A1
• Time in Patent Office: 1,240 Days
• Field of Search: 600/573, 600/576, 600/583, 606181-183, 422/58
• 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:

a plurality of elongated lancing mediums, each having a skin-piercing end adapted to be displaced against a skin site to make an incision and produce a droplet of bodily fluid;

a plurality of transport mediums, each transport medium oriented sufficiently close to a respective lancing medium to retain a droplet of bodily fluid between the transport medium and the respective lancing medium by capillary action;

a mechanism adapted to index said lancing and transport mediums into alignment with said displacement device; and

a displacement device adapted to relatively displace a lancing medium and a respective transport medium aligned with said displacement device to move the droplet of bodily fluid away from said skin site.

2. Apparatus as claimed in claim 1 wherein said lancing and transport mediums are arranged in a radial array emanating from a central axis.

3. Apparatus as claimed in claim 2 wherein said apparatus has a disk in which said lancing and transport mediums are retained.

4. Apparatus as claimed in claim 1 further comprising at least one test medium positioned adjacent at least one said lancing medium and respective transport medium, said displacement device being adapted to displace said lancing medium and said respective transport medium to move the droplet of bodily fluid away from said skin site and to said test medium.

5. Apparatus as claimed in claim 4 further comprising an indexing device adapted to index said test medium and position a selected test medium element adjacent said at least one lancing medium and respective transport medium, wherein said test medium comprises a plurality of test medium elements adjacent one another.

6. Apparatus as claimed in claim 5 wherein said test medium comprises a plurality of test medium elements arranged in a roll.

7. Apparatus as claimed in claim 5 wherein said test medium comprises a plurality of test elements arranged in a circular array, said test medium being rotatable to index selected test medium elements to be adjacent said at least transport and respective lancing medium.

8. Apparatus as claimed in claim 5 wherein said plurality of lancing mediums and said plurality of transport mediums are arranged in a radial array emanating from a central axis, wherein said plurality of test medium elements are arranged in a circular array, wherein said radial array of lancing and transport mediums and said circular array of test medium elements are adjacent to and independently rotatable of one another, and wherein said lancing and transport mediums are positioned to apply droplets of bodily fluid to said test medium elements.

9. Apparatus as claimed in claim 8 further comprising a light source arranged to illuminate selected test medium elements to which a droplet of bodily fluid has been applied.

10. Apparatus as claimed in claim 9 wherein said plurality of test medium elements rotate to individually align with said light source.

11. Apparatus as claimed in claim 9 further comprising a light guide extending from said test medium and a sensor receiving said light for indicating the condition of said sample.

12. Apparatus as claimed in claim 1, wherein one of said lancing medium and a respective transport medium has hydrophilic material on its surface and the other has hydrophobic material on its surface.

13. Apparatus as claimed in claim 1, wherein said displacement device is adapted to advance a transport medium aligned with said displacement device to contact the skin surface before said respective lancing medium aligned with said displacement device is displaced against the skin site to make an incision.

14. An apparatus for obtaining a sample of bodily fluid, comprising:

a housing with individual compartments;

a plurality of lancing medium and transport medium pairs, wherein a first lancing medium and transport medium pair is contained in a first compartment and a second lancing medium and transport medium pair is contained in a second compartment, wherein the first and second compartments are adapted to maintain separate sterile environments, and wherein the lancing medium and the transport medium in a pair are individually extendable to lance the skin and move a droplet of bodily fluid away from the skin surface.

15. The apparatus of claim 14 further comprising:

an actuating device adapted to extend the lancing medium and the transport medium of a pair; and

a mechanism adapted to index the housing to sequentially align the plurality of lancing and transport medium pairs with the actuating device.

16. The apparatus of claim 15, wherein the actuating device extends the lancing medium of a pair independently of the transport medium of the pair.

17. The apparatus of claim 14, wherein one of the lancing and transport mediums of a pair includes at least two abutment portions stepped in relation to one another, and wherein the other of the lancing and transport mediums of the pair includes a stop adapted to contact the at least two abutment portions and limit the extension of the lancing medium beyond the transport medium.

18. The apparatus of claim 17, further comprising a mechanism to rotate a lancing and transport mediums of a pair relative to one another to selectively align the stop with an abutment portion and adjust the distance the lancing medium extends beyond the transport medium.

19. The apparatus of claim 14, further comprising a plurality of test elements, the plurality of test elements adapted to position at least one test element adjacent a lancing and transport medium pair to receive a sample of bodily fluid held by the lancing and transport medium pair and to test the sample for an analyte.

20. The apparatus of claim 14, wherein the lancing medium and the transport medium of a pair are positioned adjacent one another to retain a droplet of bodily fluid therebetween by capillary action.

21. A method, comprising:

aligning a first lancing medium and a first transport medium with an actuating device, the first lancing medium and the first transport medium being adjacent one another in a first compartment;

moving the first lancing medium with the actuating device to penetrate a skin surface at a penetration site;

moving a first body fluid sample from the penetration site away from the penetration site with the first transport medium;

applying the first body fluid sample moved with the first transport medium to a first test element;

testing the first body fluid sample for an analyte with the first test element;

positioning the first lancing medium, first transport medium and first compartment away from alignment with the actuating device; and

aligning a second lancing medium and a second transport medium with the actuating device, the second lancing medium and the second transport medium being adjacent one another in a second compartment adapted to maintain a separate sterile environment from the first compartment.

22. The method of claim 21, further comprising

moving the first transport medium independently from said first lancing medium.

23. The method of claim 21, further comprising

stopping the moving of the first lancing medium by contacting one of at least two abutment portions with a stop, wherein one of the first lancing medium and the first transport medium includes the stop and the other of the first lancing medium and the first transport medium includes the at least two abutment portions, the at least two abutment portions being stepped in relation to one another.

24. The method of claim 21, further comprising

contacting the skin surface with the transport medium before said moving the first lancing medium to penetrate the skin surface.

25. The method of claim 21, further comprising

moving the second lancing medium with the actuating device to penetrate a skin surface at a second penetration site;

moving a second body fluid sample from the second penetration site away from the second penetration site with the second transport medium;

applying the second body fluid sample moved with the second transport medium to a second test element;

testing the second body fluid sample for an analyte with the second test element.