Lancet device having capillary action

• US 6,866,675 B2
• Filed: 01/22/2002
• Issued: 03/15/2005
• 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.
• Primary Examiner(s): Reip, David O.
• Assistant Examiner(s): DAVIS, DANIEL J
• Application Number:
  US10/054,270
• Publication Number:
  US 20020103499A1
• Time in Patent Office: 1,148 Days
• Field of Search: 606/181, 606/182, 606/183, 600/583, 604/168.01, 604/158, 604/164.09, 604/164.11, 604/264
• US Class Current: 606/181
• 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 spring in communication with the lancet and the carrier, an annular space disposed within the main body adjacent the lancet, and a testing device for measuring a body fluid. The testing device 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;

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

at least one testing element in communication with said annular space;

wherein said testing element is a test strip; and

wherein said test strip is radially mounted around said lancet.

2. 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;

e) a testing means for testing the body fluid drawn into said annular space; and

a holder holding said testing means in said annular space.

3. The system of claim 2 wherein said testing means comprises at least one test element in communication with said annular space.

4. The system of claim 2 wherein said testing means comprises analysis equipment operable to test the body fluid in said annular space.

5. The system of claim 4 wherein said testing means further comprises electrochemical sensors mounted within said annular space and in communication with said analysis equipment.

6. The system of claim 4 wherein said main body is placed in said analysis equipment after a body fluid sample is collected.

7. The system of claim 6 wherein said testing device tests the body fluid using optical transmittance, reflectance or flourescence.

8. The system of claim 6 wherein said testing device tests the body fluid using electrochemical sensors situated to communicate with said annular space.

9. The system of claim 2, wherein said holder includes an opening defined in said main body.

10. The system of claim 2, further comprising a retraction mechanism configured to retract said lancer.

11. The system of claim 10, wherein said retraction mechanism includes a spring disposed in said annular space.

12. The system of claim 2, wherein said annular space is between 10 and 500 μ

m.

13. The system of claim 2, wherein said annular space is between 20 and 200 μ

m to optimize fill time.

14. The system of claim 2, wherein said lancet is hydrophilic.

15. The system of claim 14, wherein said lancer is coated with a hydrophilic material.

16. The system of claim 2, wherein:

said main body has an interior surface defining said capillary channel; and

said interior surface is hydrophilic.

17. 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 and a lancet disposed in said capillary channel that together define a capillary space adjacent tissue at a desired sample location;

b) advancing the 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 space through capillary action.

18. The method of claim 17 further comprising the step of testing the acquired body fluid while the fluid is contained in said capillary channel.

19. The method of claim 18 further comprising the step of testing the acquired body fluid for a blood glucose level.

20. The method of claim 17 further comprising the step of transferring the fluid from said capillary channel to a testing element and thereafter testing the fluid.

21. The method of claim 17 further comprising the step of testing the acquired body fluid with testing means communicating with said capillary channel.

22. The method of claim 18, wherein said testing the acquired body fluid includes optically testing the acquired body fluid.

23. A body fluid sampling device, comprising:

a body;

a lancet slidably received in the body to lance an incision in skin, wherein the lancet and the body define a capillary space that is sized to draw the body fluid via capillary action; and

a test means disposed in the capillary space to test the body fluid drawn by the capillary space.

24. The device of claim 23, wherein the test means includes a test strip.

25. The device of claim 23, further comprising a holder holding the test means in the capillary space.

26. The device of claim 25, wherein the holder includes an opening defined in the body.

27. The device of claim 23, further comprising a retraction mechanism configured to retract the lancet.

28. The device of claim 27, wherein the retraction mechanism includes a spring surrounding the lancer.

29. The device of claim 23, wherein the capillary space is sized between 10 and 500 μ

m.

30. The device of claim 23, wherein the capillary space is sized between 20 and 200 μ

m.

31. The device of claim 23, wherein the lancet is hydrophilic.

32. The device of claim 31, wherein the lancet is coated with a hydrophilic material.

33. The device of claim 23, wherein the body is hydrophilic.

34. The device of claim 33, wherein the body is coated with a hydrophilic material around the capillary space.

35. The device of claim 23, wherein the body has a generally cylindrical shape.

36. The device of claim 23, wherein the lancet has a generally cylindrical shape.

37. The device of claim 23, wherein the body is made of a bio-compatible plastic.

38. The device of claim 23, wherein the test means is optically reactive.

39. The device of claim 23, wherein at least a portion of the body adjacent the test means is transparent.

40. The device of claim 23, wherein the body is transparent.

41. The device of claim 23, wherein the lancet is adapted to advance from the body a distance between approximately 0.05 mm and 3 mm.

42. The device of claim 23, further comprising a sealing member enclosing an end of the capillary space.

43. The device of claim 42, wherein the sealing member includes a safety cap covering the lancet.

44. The device of claim 23, the test means includes a membrane.

45. The device of claim 23, wherein the test means includes two or more testing elements.

46. The device of claim 23, wherein the test means includes one or more electrochemical sensors disposed within the capillary space.

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

a main body defining a capillary channel;

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

wherein said lancet is selectively advancable and retractable;

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

a testing means for resting the body fluid drawn into said annular space; and

a retraction mechanism configured to retract said lancer, wherein said retraction mechanism includes a spring disposed in said annular space.