Device for sampling bodily fluids

• US 7,645,241 B2
• Filed: 04/20/2005
• Issued: 01/12/2010
• 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 GERBEN
• Application Number:
  US11/110,593
• Publication Number:
  US 20060052724A1
• Time in Patent Office: 1,728 Days
• Field of Search: 600/583, 600/580, 600/579, 600/576, 600/573, 606/181, 606/182
• US Class Current: 600/583
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157
• 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 and a stop, said skin piercing end adapted to be displaced against a skin site for making an incision and producing a droplet of bodily fluid from the skin site;

a transport medium with a first stepped portion and a second stepped portion, said transport medium being sufficiently close to said lancing medium to retain the droplet of bodily fluid therebetween by capillary action, said stop being adapted to selectably contact one of the stepped portions while making an incision, the distance said skin piercing end extends beyond said transport medium with the stop contacting the first stepped portion being different from the distance said skin piercing end extends beyond said transport medium with the stop contacting the second stepped portion; and

an actuating device connected to said lancing medium and said transport medium, wherein said actuating device displaces said lancing medium and said transport medium away from said skin site to move the droplet of bodily fluid retained by said transport medium and said lancing medium away from said skin site.

2. Apparatus as claimed in claim 1 wherein at least one of said lancing medium and said transport medium is hydrophilic and the other is hydrophobic.

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

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

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

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

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

8. Apparatus as claimed in claim 7 wherein said lancing medium is circular in cross section and said transport medium discrete element is a half-round element embracing a portion of the circumference around said lancing medium.

9. Apparatus as claimed in claim 7 wherein said lancing medium comprises a needle with a circular cross section and said transport medium discrete element comprises an element having an opening there through embracing the circumference of said needle and through which said lancing medium extends.

10. Apparatus as claimed in claim 1, further comprising:

a rotating device connected to said lancing medium, said rotating device adapted to rotate said lancing medium relative to said transport medium to align the stop with different steps of said stepped portion and vary the distance said skin piercing end extends past said transport medium while making an incision.

11. Apparatus as claimed in claim 1, further comprising an actuating device connected to said lancing medium and said transport medium, wherein said actuating device displaces said lancing medium and said transport medium, and wherein said actuating device displaces said lancing medium to contact the skin before the lancing medium.

12. Apparatus for sampling bodily fluid from a skin, comprising:

a lancet with a tip for forming an incision in the skin and a stop;

a sheath adjacent the lancet with a semicircular disk extending toward the lancet, the semicircular disk including a skin contacting surface adapted to contact the skin; and

an actuator connected to the lancet and the sheath, the actuator configured to rotate the sheath and the lancet relative to one another from

a first position wherein the stop restricts the lancet tip from extending beyond the skin contacting surface,

to a second position wherein the stop does not restrict the lancet tip from extending beyond the skin contacting surface.

13. Apparatus as claimed in claim 12, wherein the lancet includes the stop and the sheath includes a stepped portion adapted to contact the stop and limit the distance the lancet extends beyond the sheath while forming the incision.

14. Apparatus as claimed in claim 13, wherein the lancet and the sheath are adapted to rotate with respect to one another and align the stop with different portions of the stepped portion to select one of at least two different distances the lancet extends beyond the sheath while forming the incision.

15. Apparatus as claimed in claim 12, further comprising:

a plurality of the lancets and the sheaths attached to one another and arranged in a disk with the plurality of lancets oriented radially; and

a mechanism for individually indexing the plurality of lancets and sheaths into alignment with a lancet actuator, the lancet actuator configured to move a lancet aligned with the lancet actuator to form an incision in the skin.

16. 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,

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

an actuating device connected to said lancing medium and said transport medium, said actuating device adapted to rotate said lancing medium and said transport medium relative to one another,

wherein a first rotational orientation between said lancing medium and said transport medium aligns a first pair of abutment portions, one abutment portion being on said lancing medium and one abutment portion being on said transport medium, said skin piercing end being displaced a first distance from said skin contacting surface when the first pair of abutment portions abut one another, and

wherein a second rotational orientation between said lancing medium and said transport medium aligns a second pair of abutment portions, one abutment portion being on said lancing medium and one abutment portion being on said transport medium, said skin piercing end being displaced a second distance from said skin contacting surface wl4en the second pair of abutment portions abut one another, said second distance being different from said first distance.

17. Apparatus as claimed in claim 16, wherein the transport medium is adapted to contact the skin site before the lancing medium skin piercing end is displaced against the skin site.

18. Apparatus as claimed in claim 16 wherein said fluid retaining member is a raised surface.

19. Apparatus as claimed in claim 16, wherein the lancing medium includes a stop with a first abutment portion and the transport medium includes a stepped portion with second and third abutment portions, wherein the first pair includes the first and second abutment portions, and wherein the second pair includes the first and third abutment portions.

20. Apparatus as claimed in claim 19, further comprising:

a disk with a plurality of the lancing and transport mediums arranged on the disk in pairs, the plurality of lancing and transport mediums pairs being radially arranged on the disk.

21. Apparatus as claimed in claim 20, further comprising:

a drive member adapted to move a lancing medium and a transport medium aligned with the drive member toward and away from the skin surface; and

an indexing member adapted to index the plurality of lancing medium and transport medium pairs into alignment with the drive member.

22. Apparatus as claims in claim 16, wherein one of said lancing and transport mediums has a hydrophobic surface and the other has a hydrophilic surface.

23. Apparatus as claimed in claim 16, wherein said skin piercing end is retracted from the skin contacting surface and does not penetrate the skin site when said first pair of abutment portions abut one another and said skin contacting surface is in contact with said skin site.

24. Apparatus as claimed in claim 16, wherein said skin piercing end is displaced beyond the skin contacting surface to penetrate the skin site when said second pair of abutment portions abut one another and said skin contacting surface is in contact with said skin site.

25. Apparatus for sampling bodily fluids comprising:

an elongated lancing medium having a skin piercing end and a stop, said skin piercing end adapted to be displaced against a skin site for making an incision and producing a droplet of bodily fluid from the skin site; and

a transport medium with a first stepped portion and a second stepped portion, said transport medium being sufficiently close to said lancing medium to retain the droplet of bodily fluid therebetween by capillary action, said stop being adapted to selectably contact one of the stepped portions while making an incision, the distance said skin piercing end extends beyond said transport medium with the stop contacting the first stepped portion being different from the distance said skin piercing end extends beyond said transport medium with the stop contacting the second stepped portion;

wherein said transport medium comprises a discrete element displaceable relative to said lancing medium; and

wherein said lancing medium is circular in cross section and said transport medium discrete element is a half-round element embracing a portion of the circumference around said lancing medium.

26. Apparatus as claimed in claim 25 wherein at least one of said lancing medium and said transport medium is hydrophilic and the other is hydrophobic.

27. Apparatus as claimed in claim 26 wherein said transport medium is formed from hydrophilic material.

28. Apparatus as claimed in claim 26 wherein said transport medium is coated with hydrophilic material.

29. Apparatus as claimed in claim 26 wherein said transport medium is coated with polyamide hydrophilic material.

30. Apparatus as claimed in claim 26 wherein said transport medium is formed from polyamide hydrophilic material.

31. Apparatus as claimed in claim 25 further comprising an actuating device connected to said lancing medium and said transport medium, wherein said actuating device displaces said lancing medium and said transport medium away from said skin site to move the droplet of bodily fluid retained by said transport medium and said lancing medium away from said skin site.