Lancet device having capillary action

• US 20020103499A1
• Filed: 01/22/2002
• Published: 08/01/2002
• Est. Priority Date: 01/22/2001
• 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., Perez, Edward P.
• Granted Patent: US 6,866,675 B2
• Time in Patent Office: Days
• US Class Current: 606/182
• CPC Class Codes: A61B 2010/008 Interstitial fluid
• 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 5/14514 using means for aiding extraction of interstitial fluid, e.g. microneedles or suction
• 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 5/150175 Adjustment of penetration depth
• 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 5/150389 Hollow piercing elements, e.g. canulas, needles, for piercing the skin
• CPC Class Codes: A61B 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/15087 short range, e.g. between console and disposable using implanted devices A61B5/150877
• 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 5/15144 comprising driving means, e.g. a spring, for retracting the piercing unit into the housing
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: G01N 35/1079 with means for piercing stoppers or septums

Abstract

A device for sampling body fluid, the device comprising, a main body, a lancet disposed within the main body, a carrier disposed within the main body fixedly attached to the lancet, a biasing means in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a means for measuring a body fluid. Wherein the means for measuring the body fluid may include micro-porous test strips, an electronic testing device, an optical/reflectance testing measuring device, or a visual inspection.

Claims

1. A device for sampling body fluid, comprising:

a) a main body defining a capillary channel;

b) a lancet disposed within said capillary channel and defining an annular space between said lancet and said main body;

c) wherein said lancet is selectively advancable and retractable; and

,

d) wherein said capillary channel is dimensioned to draw a body fluid into said annular space through capillary action.

2. The device of claim 1 further comprising at least one testing element in communication with said annular space.

3. The device of claim 2 wherein said testing element is a test strip.

4. The device of claim 3 wherein said test strip is a membrane.

5. The device of claim 3 wherein said test strip is radially mounted around said lancet.

6. The device of claim 3 wherein said test strip is mounted in a groove defined in said lancet.

7. The device of claim 3 wherein said test strip is mounted in a groove defined in said main body.

8. The device of claim 2 further comprising two or more testing elements in communication with said annular space.

9. The device of claim 2 wherein said testing element comprises electrochemical sensors within said annular space.

10. The device of claim 2 further comprising biasing means to selectively retract said lancet.

11. The device of claim 10 further comprising biasing means to selectively advance said lancet.

12. The device of claim 10 wherein said biasing means is a spring operable to provide relative movement between said lancet and said main body.

13. The device of claim 12 wherein said spring is mounted within said capillary channel between a bearing surface on said main body and a bearing surface on said lancet.

14. The device of claim 13 wherein said spring comprises a bio-compatible material.

15. The device of claim 2 wherein said main body has a generally cylindrical shape.

16. The device of claim 15 wherein said main body comprises a bio-compatible plastic.

17. The device of claim 3 wherein said test strip is optically reactive.

18. The device of claim 17 wherein at least a portion of said main body adjacent said test strip is transparent.

19. The device of claim 17 wherein said main body is transparent.

20. The device of claim 2 wherein said main body defines a distal opening to said capillary channel and wherein said device further comprises a tip covering said opening and penetrable by said lancet.

21. The device of claim 2 wherein said lancet advances from said main body a distance between approximately 0.05 mm and 3 mm.

22. A system for sampling and testing a body fluid, comprising:

a) a main body defining a capillary channel;

b) a lancet disposed within said capillary channel and defining an annular space between said lancet and said main body;

c) wherein said lancet is selectively advancable and retractable;

d) wherein said capillary channel is dimensioned to draw a body fluid into said annular space through capillary action; and

,

e) a testing means for testing the body fluid drawn into said capillary channel.

23. The system of claim 22 wherein said testing means comprises at least one test element in communication with said annular space.

24. The system of claim 22 wherein said testing means comprises analysis equipment operable to test the body fluid in said annular space.

25. The system of claim 25 wherein said testing means further comprises electrochemical sensors mounted within said annular space and in communication with said analysis equipment.

26. The system of claim 24 wherein said main body is placed in said analysis equipment after a body fluid sample is collected.

27. The system of claim 26 wherein said testing device tests the body fluid using optical transmittance, reflectance or flourescence.

28. The system of claim 26 wherein said testing device tests the body fluid using electrochemical sensors situated to communicate with said annular space.

30. The device of claim 29 further comprising testing means in communication with said annular space for analyzing the body fluid.

31. The device of claim 30 wherein said testing means comprises electrochemical measuring equipment associated with said base unit.

29. A device for sampling body fluid, comprising:

a) a base unit;

b) a disposable main body mountable to said base unit and defining a capillary channel;

c) a lancet disposed within said capillary channel and defining an annular space between said lancet and said main body;

d) injection means associated with said base unit and releasably coupleable to said lancet, wherein said injection means is operable to selectively advance and retract said lancet; and

,

e) wherein said capillary channel is dimensioned to draw a body fluid into said annular space through capillary action.

32. A method of obtaining a fluid sample from the body of a person, comprising the steps of:

a) placing an apparatus having a defined capillary channel adjacent tissue at a desired sample location;

b) advancing a lancet disposed within said capillary channel so that said lancet incises tissue at an incision point in the desired sample location;

c) retracting said lancet into said capillary channel; and

,

d) acquiring body fluid expressed from the body at the incision point into said capillary channel through capillary action.

33. The method of claim 32 further comprising the step of testing the acquired body fluid while the fluid is contained in said capillary channel.

34. The method of claim 32 further comprising the step of transferring the fluid from said capillary channel to a testing element and thereafter testing the fluid.

35. The method of claim 32 further comprising the step of testing the acquired body fluid with testing means communicating with said capillary channel.

36. The method of claim 33 further comprising the step of testing the acquired body fluid for a blood glucose level.

38. The device of claim 37, wherein said means for testing blood glucose levels comprises an electronic meter disposed adjacent said proximal end of said main body and having sensors in communication with said annular space.

42. The method according to claim 39 in which said lancet is movable relative to said main body.

43. The method according to claim 39 in which said lancet is fixed in position relative to said main body.

37. A device for measuring blood glucose levels, the device comprising:

a) a main body having a generally cylindrical shape, a proximal end and a distal end;

b) a lancet disposed within said main body, wherein an annular space is disposed about said lancet and defined by said main body, and said lancet protrudes beyond said distal end of said main body; and

,

c) a means for testing blood glucose levels in communication with said annular space.

39. A method for sampling a body fluid, comprising the steps of:

a) providing a testing apparatus with a main body defining a capillary channel, and a lancet disposed within said capillary channel and defining an annular space between said lancet and said main body;

b) placing the testing apparatus over a site to be lanced;

c) advancing said lancet into the site thereby creating an incision; and

,

d) withdrawing a body fluid into said annular space through capillary action.

40. The method according to 39 further including the step of withdrawing said lancet from said incision prior to withdrawing the body fluid.

41. The method according to claim 40 wherein said lancet is withdrawn to between 0 and 2 mm from said site.