TAPE TRANSPORT LANCE SAMPLER

• US 20110230905A1
• Filed: 06/02/2011
• Published: 09/22/2011
• 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 8,852,124 B2
• Time in Patent Office: Days
• US Class Current: 606/181
• 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 5/1411 by percutaneous method, e.g. by lancet
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• 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 5/150282 for piercing elements, e.g. blade, lancet, canula, needle
• CPC Class Codes: A61B 5/150305 Packages specially adapted for piercing devices or blood sampling devices kits for diabetes A61M5/003; packaging in general B65D
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150435 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 5/15061 by material engagement, e.g. welding, bonding
• 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 5/151 Devices specially adapted for taking samples of capillary blood, e.g. by lancets , needles or blades
• 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 5/15128 comprising 2D- or 3D-shaped elements, e.g. cams, curved guide rails or threads comprising tooth-shaped elements A61B5/15132
• CPC Class Codes: A61B 5/15132 comprising tooth-shaped elements, e.g. toothed wheel or rack and pinion
• CPC Class Codes: A61B 5/15146 : Devices loaded with multiple lancets simultaneously, e.g. for serial firing without reloading, for example by use of stocking means. multiple simultaneous cutting or piercing A61B5/150977
• CPC Class Codes: A61B 5/15153 : Multiple piercing elements stocked in a single compartment
• CPC Class Codes: A61B 5/15167 : Characterized by a folded strip
• CPC Class Codes: A61B 5/15169 : Characterized by a rolled 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 5/15184 : Piercing device comprising a separate compartment or unit for used piercing elements separate compartments for used piercing elements in stocking means A61B5/15178
• CPC Class Codes: A61B 5/157 : Devices characterised by integrated means for measuring characteristics of blood

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 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.

2. The lancet-sampler of claim 1, wherein the segment that extends completely through the lancet extends for the entire length of the groove.

3. The lancet-sampler of claim 2, further comprising:

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

4. The lancet-sampler of claim 2, wherein the groove on the second side is uncovered so that the capillary channel is open on the second side.

5. The lancet-sampler of claim 1, wherein the segment that extends completely through the lancet has the same width as the rest of the groove.

6. The lancet-sampler of claim 1, wherein the segment that extends completely through the lancet is wider than the rest of the groove.

7. The lancet-sampler of claim 1, 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.

8. A method of manufacturing a lancet-sampler, comprising:

forming a lancet having a body and a lancet tip extending from the body configured to cut an incision in tissue, wherein the lancet has opposing first and second sides,

creating a groove in the first side of the lancet that extends from the lancet tip to the body;

wherein the groove has at least a segment that extends completely through the lancet from the first side to the second side; and

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

9. The method of claim 8, wherein the segment that extends completely through the lancet extends for the entire length of the groove.

10. The method of claim 9, further comprising:

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

11. The method of claim 9, wherein the groove on the second side is uncovered so that the capillary channel is open on the second side.

12. The method of claim 8, wherein said creating the groove includes making the segment that extends completely through the lancet with the same width as the rest of the groove.

13. The method of claim 8, wherein said creating the groove includes making the segment that extends completely through the lancet wider than the rest of the groove.

14. The method of claim 8, wherein said creating the groove includes:

etching a fully-etched section of the groove;

etching a partially etched section of the groove;

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

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

wherein 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.

15. The method of claim 8, wherein said covering includes heat sealing the cover via a continuous reel-to-reel process.

16. The method of claim 8, wherein said creating the groove includes etching the groove.

17. The method of claim 8, wherein said creating the groove includes punching the groove.

18. The method of claim 8, further comprising:

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

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