Tape transport lance sampler

• US 7,955,271 B2
• Filed: 10/13/2006
• Issued: 06/07/2011
• Est. Priority Date: 10/13/2006
• Status: Expired due to Fees

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Beaty, Terry, Roe, Steven N., Zimmer, Volker, Kraemer, Uwe
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): SZMAL, BRIAN SCOTT
• Application Number:
  US11/549,302
• Publication Number:
  US 20080103415A1
• Time in Patent Office: 1,698 Days
• Field of Search: 600/573, 600/575, 600583-585, 606181-183, 297/41, 297/42, 297/48, 297/49, 298/27
• 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, wherein the slackened section is longer than the distance between where the tape is coupled to the lancet and where the tape is coupled to the protective cover.

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 3, further comprising:

the capillary groove being partially etched;

the sample transfer opening being fully etched;

the sample transfer opening being wider than the capillary groove; and

the lancet having a fully etched section having the same width as the capillary groove, the fully etched section being located between the capillary groove and the sample transfer opening to provide a gradual transition between the capillary groove and the sample transfer opening to allow momentum of the body fluid sample to carry the body fluid sample to the sample transfer opening.

7. 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.

8. 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.

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

10. The device of claim 1, wherein the slackened section includes a section of the tape that is folded.

11. The device of claim 10, wherein the section of the tape that is folded is folded in a fanfold manner.

12. The device of claim 1, wherein the slackened section is at least long enough for the protective cover to clear the lancet tip.

13. The device of claim 1, further comprising:

the lancet including a body located opposite the lancet tip;

the tape being attached to the body of the lancet;

the tape being attached to the protective cover at the lancet tip; and

the slackened section of the tape being located between the body and the lancet tip.

14. The device of claim 13, wherein the slackened section includes a section of the tape that is folded.

15. The device of claim 1, wherein the tape and the protective cover are separate components.

16. The device of claim 1, further comprising:

a spool around which the tape is wrapped.

17. The device of claim 1, wherein the tape is longer than the lancet.

18. The device of claim 1, further comprising:

a cassette in which the lancet, the protective cover, and the tape is stored, the cassette including

a storage compartment in which an unused section of the tape is stored, the tape being folded in a fanfold manner inside the storage compartment, and

a spool around which the tape is wrapped for indexing the tape.

19. The device of claim 18, further comprising:

the lancet being stored in a tip first orientation when within the storage compartment and a tail first orientation when wrapped around the spool; and

the cassette further including

a guide pin upon which the tape rides between the storage compartment and the spool,

the storage compartment, the guide pin, and the spool being oriented in a triangular relationship in which the tape extends at an acute angle relative to the guide pin, and

a flip wall defining a lancet opening through which the lancet extends during lancing, the flip wall being located between the guide pin and the spool to flip the lancet from the tip first orientation to the tail first orientation when the lancet is indexed from the storage compartment to the spool.

20. The device of claim 19, further comprising:

the lancet having an engagement hole; and

a firing engaging the engagement hole to hold the lancet in place when the protective cover is pulled from the lancet.

21. A body fluid sampling device, comprising:

a lancet configured to lance an incision in tissue; and

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

22. The device of claim 21, wherein the lancet defines a capillary groove configured to draw body fluid from the incision via capillary action.

23. The device of claim 22, 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.

24. The device of claim 22, further comprising a hydrophilic cover covering at least a portion of the capillary groove to form a closed capillary channel.

25. The device of claim 21, wherein the tape folded around the test pad is sealed together to form an airtight packet.

26. The device of claim 25, wherein the packet is sealed with a peelable adhesive for allowing the tape around the test pad to peel apart.

27. The device of claim 21, 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.

28. A body fluid sampling device, comprising:

a lancet including

a lancet tip configured to lance tissue,

a body located opposite the lancet tip, and

the lancet defining

a sample transfer opening that extends through opposing sides of the body, and

a capillary groove that extends from the sample transfer opening to the lancet tip for transferring body fluid from the tissue to the sample transfer opening;

a protective cover covering at least a portion of the lancet tip that lances the tissue;

a test pad configured to analyze the body fluid;

a tape having an intermediate section folded around the test pad to form a sealed packet that seals the test pad from exposure to the lancet and the outside environment, the tape being attached to the body of the lancet and the protective cover with the intermediate section having the sealed packet being located in between;

the sealed packet being configured to unfolded when tension is applied to the tape;

the intermediate section being longer that than the distance between the body and the lancet tip when the sealed packet is unfolded to allow the protective cover to pull away from the lancet tip; and

the test pad being positioned on the intermediate section of the tape to align with the sample transfer opening when the sealed packet is unfolded for transferring the body fluid from the sample transfer opening onto the test pad.

29. The device of claim 28, further comprising:

the tape having a first configuration where the test pad is sealed inside the sealed packet and the test pad is out of contact with the sample transfer opening, wherein when in the first configuration the test pad is unable to receive the body fluid from the sample transfer opening;

the tape having a second configuration where the sealed packet is unfolded and the test pad is aligned with the sample transfer opening, wherein when in the second configuration the test pad is able to receive the body fluid from the sample transfer opening; and

the tape being configured to move from the first configuration to the second configuration when the tension is applied to the tape.

30. The device of claim 28, wherein the tape has a plurality of the lancets and test pads.