Integrated lancing test strip

• US 7,374,546 B2
• Filed: 01/29/2004
• Issued: 05/20/2008
• Est. Priority Date: 01/29/2003
• 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., Roe, Jeffrey N., Zimmer, Volker, Raney, Charles C.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Lloyd; Emily M.
• Application Number:
  US10/767,522
• Publication Number:
  US 20040186394A1
• Time in Patent Office: 1,573 Days
• Field of Search: 600/583, 600/573, 600/576, 600/584, 606/181
• 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 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• CPC Class Codes: A61B 5/150213 Venting means
• 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 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/150824 by visual feedback
• 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

Abstract

An integrated bodily fluid sampling device is used to sample a bodily fluid from an incision in skin. The device includes a lancet for forming the incision in the skin. A housing is coupled to the lancet. The housing defines at least in part a capillary channel with an opening. The capillary channel is sized to draw the bodily fluid from the incision via capillary action. A test strip is positioned along the capillary channel for analyzing the fluid. In one form, a flexible sheet extends from the housing proximal the opening of the capillary channel for drawing the bodily fluid into the opening of the capillary channel. In another form, the lancet is slidably received inside the channel. During lancing, the lancet extends from the housing to form the incision. Fluid from the incision is drawn into the channel and is deposited on the test strip for analysis.

Claims

1. A device for sampling a bodily fluid from an incision in skin, comprising:

a lancet having a lancet tip to form the incision in the skin;

a housing coupled to the lancet, the housing defining at least in part a capillary channel with an opening, the capillary channel being sized to draw the bodily fluid from the incision via capillary action;

the lancet tip extending from the capillary channel opening, the lancet tip being immovable relative to the housing;

a flexible sheet having a sampling end portion extending from the opening of the capillary channel;

the sampling end portion being flexible to bend against the skin as the lancet forms the incision; and

the sampling end portion of the flexible sheet being at least as long as the lancet tip to draw the bodily fluid into the opening of the capillary channel when the lancet tip is retracted from the incision.

2. The device of claim 1, wherein the housing defines a notch at the opening of the capillary channel to minimize dose hesitation of the bodily fluid into the capillary channel.

3. The device of claim 1, wherein the sheet is hydrophilic for enhancing the flow rate of the bodily fluid into the capillary channel.

4. The device of claim 3, wherein the sheet is coated with a hydrophilic coating.

5. The device of claim 4, wherein the hydrophilic coating includes aluminum oxide.

6. The device of claim 1, wherein the sheet is transparent for allowing a user to view the bodily fluid while being drawn into the capillary channel.

7. The device of claim 1, wherein:

the housing has an outside surface; and

the lancet is attached to the outside surface of the housing.

8. The device of claim 7, wherein the lancet is glued to the outside surface of the housing.

9. The device of claim 1, wherein the housing defines a registration opening for positioning the housing.

10. The device of claim 1, wherein:

the housing includes a base and a spacer member attached to the base;

the spacer member defines a slot;

the sheet covers at least a portion of the slot; and

the spacer member is sandwiched between the base and the sheet to form the capillary channel in the slot.

11. The device of claim 10, wherein the housing includes a cover covering the sheet over the slot and a vent member defining a vent opening for exhausting gas from the capillary channel.

12. The device of claim 11, further comprising a test area positioned along the capillary channel in which the bodily fluid is analyzed, wherein the vent opening is defined between the test area and the vent member.

13. The device of claim 12, wherein the test area includes a reagent test strip.

14. The device of claim 10, further comprising a test area positioned along the capillary channel for analyzing the bodily fluid.

15. The device of claim 1, wherein the lancet tip has a triangular shape.

16. The device of claim 1, wherein the lancet tip has a slanted shape.

17. The device of claim 1, wherein the lancet tip defines a slot for drawing the bodily fluid into the capillary channel.

18. The device of claim 1, wherein the sheet extends past the lancet tip in order for the sheet to remain in contact with the skin and draw the bodily fluid when the lancet tip is removed from the skin.

19. The device of claim 1, wherein the housing and the lancet are flat.

20. The device of claim 1, further comprising means for testing the bodily fluid in the capillary channel.

21. The device of claim 20, wherein the means for testing the bodily fluid includes a reagent test strip.

22. The device of claim 1, further comprising a testing system positioned along the capillary channel to analyze the bodily fluid.

23. The device of claim 22, wherein the testing system includes a reagent test strip.

24. The device of claim 22, wherein the testing system includes:

at least two electrodes; and

an electrochemical test strip positioned between the electrodes in the capillary channel.

25. The device of claim 24, wherein the housing includes:

a base made of insulating material, the electrodes extending along the base; and

a spacer made of insulating material, the electrodes being sandwiched between the base and spacer, the spacer defining a slot, wherein said sheet covers the slot to form the capillary channel.

26. The device of claim 22, wherein:

the sheet is hydrophilic; and

the sheet extends along the capillary channel to draw the bodily fluid onto the test system.

27. The device of claim 1, wherein the housing has a skin contact surface that is shaped to maintain the incision open as the housing is pressed against the skin.

28. The device of claim 27, wherein the skin contact surface and the housing are beveled.

29. The device of claim 1, further comprising a second flexible sheet extending from the housing on the opposite side of the capillary channel as the flexible sheet to draw the bodily fluid into the opening of the capillary channel without closing the incision.

30. The device of claim 29, wherein the flexible sheet and the second flexible sheet face each other.

31. The device of claim 1, wherein the lancet tip and the sampling end portion of the flexible sheet extend in a generally parallel manner.

32. The device of claim 1, wherein the flexible sheet is a plastic film.

33. A method of sampling a bodily fluid from an incision in skin, comprising:

providing a device that includes a housing that defines a capillary channel with an opening, a lancet coupled to the housing, and a flexible sheet that extends from the opening of the capillary channel, wherein the lancet includes a lancet tip extending from the opening of the capillary channel;

lancing the incision in the skin with the lancet;

bending the flexible sheet against the skin during said lancing;

retracting the lancet from the skin;

straightening the flexible sheet during said retracting; and

drawing the bodily fluid from the incision into the capillary channel with the flexible sheet.

34. The method of claim 33, further comprising:

wherein the device includes testing means positioned along the capillary channel;

depositing the bodily fluid in the capillary channel onto the testing means; and

analyzing the bodily fluid with the testing means.

35. The method of claim 34, wherein said analyzing includes chemically testing analyte levels in the bodily fluid.

36. The method of claim 34, wherein said analyzing includes electrochemically testing analyte level in the bodily fluid.

37. The method of claim 33, further comprising:

wherein the device includes testing means positioned along the capillary channel;

depositing the bodily fluid in the capillary channel onto the testing means; and

analyzing the bodily fluid with the testing means.

38. An integrated bodily fluid sampling device for sampling a bodily fluid from an incision in skin, comprising:

a housing defining a capillary channel with an opening configured to draw the bodily fluid via capillary action;

a lancet having a lancet tip for forming the incision in the skin, the lancet being attached to the housing with the lancet tip extending from around the opening of the channel, the lancet being immovable with respect to the housing;

means for testing the bodily fluid positioned along the channel;

a sheet of hydrophilic film extending from the opening of the channel, the sheet being flexible to bend as the lancet tip forms the incision; and

the sheet extending past the lancet tip for drawing the bodily fluid into the channel.

39. The device of claim 38, wherein the means for testing the bodily fluid includes a chemical reagent test strip.

40. The device of claim 38, wherein the means for testing the bodily fluid includes at least a pair of electrodes and an electrochemical reagent spanning between the electrodes.

41. The device of claim 38, wherein the lancet has a flat shape.

42. The device of claim 38, wherein the housing includes:

a base;

a cover; and

a spacer sandwiched between the base and the cover to define the channel.

43. The device of claim 42, wherein the lancet, the base, the cover and the lancet have an overall flat shape.

44. The device of claim 38, wherein the housing defines a notch at the opening of the channel for minimizing dose hesitation of the bodily fluid into the opening.

45. An apparatus, comprising:

a body fluid sampling device including

a lancet having a lancet tip for cutting an incision in skin,

a capillary channel opening for collecting body fluid from the incision,

the lancet tip extending in a fixed manner from the capillary channel opening,

a fluid collection sheet having a sampling end portion extending from the capillary channel opening, and

the sampling end portion of the fluid collection sheet being at least as long as the lancet tip for drawing the body fluid from the incision into the capillary channel opening.

46. The apparatus of claim 45, in which the sampling end portion extends past the lancet tip.

47. A method, comprising:

cutting an incision in skin with a lancet of a body fluid sampling device that includes a capillary channel with an opening, wherein the lancet is immovable relative to the body fluid sampling device, wherein the sampling device includes a fluid collection sheet that is flexible;

bending the fluid collection sheet against the skin during said cutting the incision;

retracting the lancet from the incision; and

drawing body fluid from the incision into the opening of the capillary channel with the fluid collection sheet.

48. The method of claim 47, further comprising:

wherein the fluid collection sheet extends past the end of the lancet; and

maintaining contact of the fluid collection sheet against the skin during said drawing the body fluid.