Tape transport lance sampler

• US 8,328,736 B2
• Filed: 06/02/2011
• Issued: 12/11/2012
• 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., Beaty, Terry A., Kraemer, Uwe, Zimmer, Volker
• Primary Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US13/151,818
• Publication Number:
  US 20110238100A1
• Time in Patent Office: 558 Days
• Field of Search: 600/573, 600583-584, 600/575, 606181-183, 297/41, 297/42, 297/48, 297/49, 298/27, 435/4
• 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 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.

2. The method of claim 1, further comprising:

depositing a test pad on the tape; and

sterilizing the lancet before said attaching the lancet and the protective cover to the tape.

3. The method of claim 1, 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.

4. The method of claim 3, 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.

5. The method of claim 1, 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.

6. The method of claim 1, further comprising:

forming a capillary groove in the lancet.

7. The method of claim 6, 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.

8. The method of claim 6, further comprising:

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

9. The method of claim 1, wherein said forming the slackened section includes folding the tape in a fanfold manner.

10. The method of claim 1, further comprising:

wherein the lancet includes a body and lancet tip extending from the body;

wherein the body is wider than the lancet tip;

wherein the protective cover covers at least a portion the lancet tip; and

wherein said attaching includes

attaching the tape to the body of the lancet, and

attaching the tape to the protective cover at the lancet tip.

11. The method of claim 1, wherein the slackened section of the tape is longer than the distance between where the tape is attached to the lancet and where the tape is attached to the protective cover.

12. 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.

13. The method of claim 12, 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.

14. The method of claim 13, 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.

15. The method of claim 14, 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.

16. The method of claim 14, further comprising:

lancing a tissue with the lancet after said aligning.

17. The method of claim 12, 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.

18. The method of claim 12, 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.

19. The method of claim 12, further comprising:

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

20. The method of claim 19, further comprising:

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

21. The method of claim 12, further comprising:

wherein the tape has a first section that extends away from where the tape is attached to the protective cover;

wherein the tape has a second section that extends away from where the tape is attached to the lancet;

wherein the slackened section is located between the first section and the second section; and

wherein said pulling the protective cover from the lancet includes applying tension to the first and second sections of the tape.

22. The method of claim 12, wherein the slackened section is longer than the distance between where the tape is attached to the lancet and where the tape is attached to the protective cover.

23. 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.

24. The method of claim 23, further comprising:

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

25. The method of claim 24, further comprising:

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

26. The method of claim 25, 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.

27. The method of claim 25, further comprising:

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

28. The method of claim 23, 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.

29. The method of claim 23, further comprising:

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

wherein the folded section of the tape is longer than the distance between where the tape is attached to the lancet and where the tape is attached to the protective cover; and

wherein said pulling the protective package apart includes pulling the protective cover from the lancet by applying tension to the tape.