Apparatus for acquiring and analyzing a blood sample

• US 8,496,602 B2
• Filed: 04/02/2010
• Issued: 07/30/2013
• Est. Priority Date: 04/03/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Harttig, Herbert, Braun, Jrgen
• Primary Examiner(s): Szmal, Brian
• Assistant Examiner(s): SMITH, FANGEMONIQUE A
• Application Number:
  US12/753,454
• Publication Number:
  US 20100256526A1
• Time in Patent Office: 1,215 Days
• Field of Search: 600/585, 600/584, 600/583, 606/181, 606/182
• US Class Current: 600/584
• 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 5/150022 for capillary blood or interstitial fluid
• CPC Class Codes: A61B 5/150183 Depth adjustment mechanism using end caps mounted at the distal end of the sampling device, i.e. the end-caps are adjustably positioned relative to the piercing device housing for example by rotating or screwing
• 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 5/150503 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 5/15113 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 5/15146 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 5/15169 Characterized by a rolled strip
• CPC Class Codes: A61B 5/15171 Characterized by propelling the piercing element perpendicular to the direction of movement of the strip
• 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
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

An automatic apparatus for obtaining and analyzing a blood sample contains a supply of lancets and test strips, which are located alternately on a carrier band. A lancet or alternatively a test strip may be clamped on a holder, which is mounted so it is movable. The movement controller of the holder comprises a three-dimensional control curve and a guide element, which engages at different depths in the control curve as a function of its relative position. The control curve comprises two guide paths, which run on different parallel planes. The contour of the first guide path determines the movement path of the lancet and the contour of the second guide path determines the movement path of the test strip. The test strip executes a transverse offset perpendicular to the puncture axis of the lancet.

Claims

1. An apparatus for obtaining and analyzing a blood sample,

comprising:

a housing;

a fixing device provided on the housing configured for contacting a body part from which a blood sample is to be taken;

at least one lancet configured for piercing the skin of the body part and being retracted;

at least one analysis element configured to be guided to the body part to take up a blood sample exiting the puncture wound;

a movably mounted holder to which the lancet and the analysis element can be coupled;

a piercing drive configured to drive the holder to execute the movements of the at least one lancet and the at least one analysis element;

a movement controller configured to guide the holder on a first movement path during which one of the at least one lancet performs a puncture movement along a puncture axis and a second movement path during which one of the at least one analysis element makes an offset movement transverse to the puncture axis;

the movement controller comprising a three-dimensional guide slot having first and second guide paths which have different depths, the contour of the first guide path determining the first movement path and the contour of the second guide path determining the second movement path; and

at least one guide element which travels along the guide slot.

2. The apparatus of claim 1, wherein the first guide path has a linear contour.

3. The apparatus of claim 1, wherein the second guide path has a curved contour, the curved contour causing the offset movement of the analysis element.

4. The apparatus of claim 1, wherein the guide slot comprises at least one ramp which connects the first guide path and the second guide path.

5. The apparatus of claim 1, wherein the guide slot is permanently connected to the holder and the guide element is fixed to the housing.

6. The apparatus of claim 1, wherein the at least one guide element is maintained in engagement with the guide slot by a spring force.

7. The apparatus of claim 6, wherein the at least one guide element comprises a guide cylinder which is mounted to allow axial displacement thereof.

8. The apparatus of claim 7, further comprising a spring which acts in the axial direction on the guide cylinder.

9. The apparatus of claim 1, wherein the holder comprises a rectangular cuboid which extends parallel to the puncture axis and the guide slot is disposed in a long side wall of the holder.

10. The apparatus of claim 1, wherein the at least one guide element extends transversely to the puncture axis.

11. The apparatus of claim 10, wherein the guide slot comprises two mirror-image guide slots provided on two opposite side walls of the holder and the at least one guide element comprises two guide elements, each of the two mirror-image guide slots being engaged by a respective one of the two guide elements, the holder being mounted between the two guide elements.

12. The apparatus of claim 11, wherein the two mirror-image guide slots are located diametrically opposite to one another.

13. The apparatus of claim 10, wherein the holder is connected to the piercing drive via an articulated coupling, thereby permitting a tilting movement of the holder around an axis perpendicular to the puncture axis.

14. The apparatus of claim 13, wherein the holder comprises a plug receptacle for a coupling pin of the piercing drive.

15. The apparatus of claim 14, further comprising a leaf spring, which presses from the side against the coupling pin and is seated in the plug receptacle.

16. The apparatus of claim 11, wherein the two mirror-image guide slots and the two guide elements are located offset to one another in the direction of the puncture axis.

17. The apparatus of claim 1, wherein the holder carries a clamping device on a front end thereof, the clamping device being configured to clamp on a lancet or a test strip.

18. The apparatus of claim 1, further comprising a replaceable cassette removably inserted in the housing and containing a supply of lancet and analysis elements.

19. The apparatus of claim 18, wherein the replaceable cassette contains a supply coil in which lancets and test strips are located on a carrier band, and a winding coil to take up used lancets and test strips.

20. The apparatus of claim 18, wherein the holder is mounted on the replaceable cassette.

21. The apparatus of claim 20, wherein the holder is located between the supply coil and the winding coil, whereby the carrier band is transported transversely to the puncture direction.