TAPE TRANSPORT LANCE SAMPLER

• US 20080103415A1
• Filed: 10/13/2006
• Published: 05/01/2008
• Est. Priority Date: 10/13/2006
• 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., Zimmer, Volker, Kraemer, Uwe, Beaty, Terry
• Granted Patent: US 7,955,271 B2
• Time in Patent Office: Days
• US Class Current: 600/583
• 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 5/150213 Venting means
• CPC Class Codes: A61B 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• 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 5/15045 comprising means for capillary action
• CPC Class Codes: A61B 5/150465 Specific design of proximal end
• 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 5/150564 Protectors removed by pulling or pushing
• CPC Class Codes: A61B 5/150702 fully automatically removed, i.e. the removing does not require any action by the user
• CPC Class Codes: A61B 5/15113 Manually triggered, i.e. the triggering requires a deliberate action by the user such as pressing a drive button
• 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 5/15123 comprising magnets or solenoids
• CPC Class Codes: A61B 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15167 Characterized by a folded strip
• CPC Class Codes: A61B 5/15173 Characterized by propelling the piercing element parallel to the direction of movement of the strip
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking
• CPC Class Codes: A61B 5/15178 Stocking means comprising separate compartments or units for new and for used piercing elements separate compartments for used piercing elements in piercing devices A61B5/15184

Abstract

A lancet-sampler system is configured to automatically remove a protective cover from a lancet and automatically unpack a test pad just prior to use. This minimizes the risk of injury and reduces the chance of cross-contamination between the lancet and the test pad. The lancet defines a capillary groove for drawing body fluid from the incision via capillary action and a sample transfer opening for collecting the fluid from the groove. A carrier tape is coupled to the lancet. The carrier tape includes a test pad for analyzing the fluid. The tape is folded around the test pad to form an airtight package. The test pad is located at a position to align with the sample transfer opening when the tape is unfolded. The protective cover covers a portion of the lancet, and when the tape is pulled, the protective cover is automatically pulled from the lancet.

Claims

1. A body fluid sampling device, comprising:

a lancet including a lancet tip configured to lance tissue;

a protective cover covering at least a portion of the lancet tip; and

a tape coupled to the lancet and the protective cover, the tape having a slackened section between the lancet and the protective cover for allowing removal of the protective cover from the lancet tip when the tape is pulled.

2. The device of claim 1, further comprising:

a test pad for analyzing a body fluid sample disposed on the tape at the slackened section;

the tape at the slackened section being folded around the test pad to form a packet for protecting the test pad prior to use; and

the packet being configured to unfold when the tape is pulled.

3. The device of claim 2, wherein:

the lancet includes a capillary groove extending along the lancet tip for drawing the body fluid sample and a sample transfer opening fluidly coupled to the capillary groove; and

the test pad is disposed on the tape at a position to align with the sample transfer opening when the packet is unfolded for transferring fluid from the sample transfer opening to the test pad.

4. The device of claim 3, further comprising a cover foil covering at least a portion of the capillary groove to form a closed capillary channel.

5. The device of claim 4, wherein the sample transfer opening has a vent slot that is left uncovered by the cover foil for venting air as the body fluid sample fills the sample transfer opening.

6. The device of claim 1, further comprising:

a first tape connector coupling the protective cover to the tape; and

a second tape connector coupling the lancet to the tape.

7. The device of claim 1, wherein the lancet defines an actuator engagement opening configured to engage an actuator member of a lancing mechanism to fire the lancet.

8. The device of claim 1, wherein the protective cover includes at least a pair of protective foils between which the lancet tip is sandwiched.

9. A method, comprising:

providing a lancet with a portion of the lancet covered with a protective cover;

forming a slackened section of a tape; and

attaching the lancet and the protective cover to the tape with the slackened section located between where the lancet and the protective cover are attached to the tape.

10. The method of claim 9, further comprising sterilizing the lancet before said attaching the lancet and the protective cover to the tape.

11. The method of claim 9, further comprising:

depositing a test pad on the tape; and

wherein said forming the slackened section includes folding the tape around the test pad to create an airtight packet.

12. The method of claim 11, wherein said attaching the lancet and the protective cover to the tape includes positioning the lancet at a position where the test pad aligns with the lancet when the packet is unfolded.

13. The method of claim 9, further comprising:

attaching a first tape connector to the protective cover;

attaching a second tape connector to the lancet; and

wherein said attaching the lancet and the protective cover to the tape includes attaching the first tape connector and the second tape connector to the tape.

14. The method of claim 9, further comprising:

forming a capillary groove in the lancet.

15. The method of claim 14, further comprising:

covering at least a portion of the capillary groove with a cover foil to form an enclosed capillary channel;

drawing a solution containing a surfactant into the enclosed capillary channel; and

making the enclosed capillary channel hydrophilic by evaporating the solution such that the surfactant remains in the enclosed capillary channel.

16. The method of claim 14, further comprising:

covering at least a portion of the capillary groove with a cover foil to form an enclosed capillary channel.

17. A method, comprising:

providing a tape assembly, wherein the tape assembly includes a tape and a lancet with a protective cover covering at least a portion of the lancet, wherein the lancet and the protective cover are attached to the tape with a slackened section of the tape located between where the lancet and the protective cover are attached to the tape; and

pulling the protective cover from the lancet by applying tension to the tape.

18. The method of claim 17, further comprising:

wherein the slackened section of the tape includes a folded section of the tape that forms a protective packet around a test pad; and

wherein said pulling the protective cover includes pulling the protective packet apart.

19. The method of claim 18, further comprising:

wherein the lancet includes a sample transfer opening where a fluid sample is collected; and

aligning the test pad with the sample transfer opening by pulling the packet apart.

20. The method of claim 19, further comprising:

lancing a tissue with the lancet before said aligning; and

collecting a fluid sample with a capillary groove in the lancet before said aligning.

21. The method of claim 19, further comprising:

lancing a tissue with the lancet after said aligning.

22. The method of claim 17, further comprising:

wherein the tape assembly is disposed in a cassette that includes at least one spool around which the tape assembly is wrapped;

engaging the protective cover with walls of a slot before said pulling; and

wherein said pulling includes rotating the spool.

23. The method of claim 17, further comprising:

wherein the tape assembly is disposed in a cassette that includes at least one spool around which the tape assembly is wrapped;

wherein the cassette includes a clutch that allows the spool to rotate in only one direction;

engaging the lancet with an actuator arm of a firing mechanism; and

wherein said pulling includes moving the lancet with the actuator arm counter to the direction the spool rotates.

24. The method of claim 17, further comprising:

wrapping the tape assembly around a spool with the lancet in a tail first orientation.

25. The method of claim 24, further comprising:

flipping the lancet from a tip first orientation to the tail first orientation before said wrapping.

26. A body fluid sampling device, comprising:

a lancet configured to lance an incision in tissue; and

a carrier tape coupled to the lancet, the carrier tape including a test pad configured to analyze the body fluid, the tape being folded around the test pad, wherein the test pad is located at a position to align with the lancet when the tape is unfolded.

27. The device of claim 26, wherein the lancet defines a capillary groove configured to draw body fluid from the incision via capillary action.

28. The device of claim 27, wherein:

the lancet has a sample transfer opening configured to collect the body fluid from the capillary groove; and

the test pad is located at a position to align with the sample transfer opening when the tape is unfolded.

29. The device of claim 27, further comprising a hydrophilic cover covering at least a portion of the capillary groove to form a closed capillary channel.

30. The device of claim 26, wherein the tape folded around the packet is sealed together to form an airtight packet.

31. The device of claim 30, wherein the packet is sealed with a peelable adhesive for allowing the tape around the test pad to peel apart.

32. The device of claim 26, further comprising a protective cover covering at least a portion of the lancet, the protective cover being attached to the tape at a position configured to pull the protective cover from the lancet when the tape is pulled.

33. A lancet-sampler, comprising:

a lancet having a body and a lancet tip extending from the body configured to cut an incision in tissue, the lancet having opposing first and second sides, the lancet defining a groove in the first side that extends from the lancet tip to the body;

a cover covering at least a portion of the groove over the first side to define a capillary channel configured to draw body fluid via capillary action; and

the groove having at least a segment that extends completely through the lancet from the first side to the second side.

34. The lancet-sampler of claim 33, wherein the segment that extends completely through the lancet extends for the entire length of the capillary groove.

35. The lancet-sampler of claim 34, further comprising:

a second cover covering at least a portion of the groove on the second side to enclose the capillary channel.

36. The lancet-sampler of claim 34, wherein the groove on the second side is uncovered so that the capillary channel is open on the second side.

37. The lancet-sampler of claim 33, wherein the segment that extends completely through the lancet has the same width as the rest of the groove.

38. The lancet-sampler of claim 33, wherein the segment that extends completely through the lancet is wider than the rest of the groove.

39. The lancet-sampler of claim 33, wherein:

the groove has a fully-etched section and a partially etched section;

the lancet defines a sample transfer opening that is wider than the groove for transferring the body fluid to a test pad;

the fully-etched section is fluidly coupled between the partially etched section and the sample transfer opening; and

the fully-etched section has the same width as the partially etched section to provide a gradual transition that allows momentum of the body fluid in the groove to carry the body fluid to the sample transfer opening.

40. A method, comprising:

providing a tape assembly that includes a tape with a folded section that forms a protective package around a test pad and a lancet attached to the tape; and

pulling the protective package apart.

41. The method of claim 40, further comprising:

aligning the test pad with the lancet when the protective package is pulled apart.

42. The method of claim 41, further comprising:

transferring a fluid sample from the lancet to the test pad after said aligning.

43. The method of claim 42, wherein:

the lancet includes a capillary groove; and

said transferring the fluid sample includes drawing the fluid sample from the capillary groove onto the test pad.

44. The method of claim 41, further comprising:

lancing skin with the lancet prior to said transferring the fluid sample.

45. The method of claim 40, further comprising:

indexing a second folded section of the tape that forms a second protective package around a second test pad to a fluid collection position; and

pulling the second protective package apart to expose the second test pad.