APPARATUS FOR OBTAINING AND ANALYZING A BLOOD SAMPLE WITH A LANCET COUPLING MECHANISM

• US 20160089069A1
• Filed: 12/10/2015
• Published: 03/31/2016
• Est. Priority Date: 10/13/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: List, Hans, Fluegge, Kai
• Granted Patent: US 10,456,070 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• 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 5/150198 Depth adjustment mechanism at the proximal end of the carrier of the piercing element
• 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 5/150419 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 5/150732 Needle holders, for instance for holding the needle by the hub, used for example with double-ended needle and pre-evacuated tube,
• CPC Class Codes: A61B 5/15111 Semi-automatically triggered, e.g. at the end of the cocking procedure, for instance by biasing the main drive spring or when reaching sufficient contact pressure, the piercing device is automatically triggered without any deliberate action by the user
• 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 5/1513 comprising linear sliding guides 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 5/15151 Each piercing element being stocked in a separate isolated compartment
• CPC Class Codes: A61B 5/15161 Characterized by propelling the piercing element in a radial direction relative to the disc

Abstract

An apparatus for obtaining and analyzing a blood sample is presented. The apparatus comprises an integrated drive unit having a common drive source and a drive force transmission gearing that couples a lancet drive, a device for advancing a magazine, and a sample transfer device to the drive source. A tensioning rotor and a drive rotor are mounted so that they are rotatable coaxially to one another. A first cam control converts the rotation of the drive rotor into a radial forward and reverse movement of a drive rod. A second cam control converts the rotational movement of the tensioning rotor into a linear movement of a link slide. A switching link moved by the link slide rotates the magazine an additional step. A third cam control converts the rotational movement of the tensioning rotor into a linear movement of a pressure tappet perpendicular to the piercing axis.

Claims

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

a housing;

a contact device provided on the housing for pressing against a body part from which the blood sample is to be taken;

a magazine movably mounted on the housing, the magazine comprising a plurality of lancets, wherein each lancet pierces the body part and retracts from the body part to receive the blood sample exiting the pierced body part;

a device for advancing the magazine to bring a lancet into a functional position;

a lancet drive having a drive rod coupled to the lancet located in the functional position, wherein the lancet drive executes a controlled piercing movement along a piercing axis;

test elements assigned to the lancets, wherein each test element receives the blood sample in order to analyze the blood sample; and

an integrated drive unit comprising the lancet drive, the device for advancing the magazine, and a device for generating a sample transfer movement perpendicular to the piercing axis.

2. The apparatus according to claim 1, wherein the integrated drive unit comprises

a common drive source, wherein the common drive source delivers a force for the lancet drive, for advancing the magazine, and for the sample transfer movement;

and

a drive force transmission gearing that couples the lancet drive, the device for advancing the magazine, and the device for generating the sample transfer movement to the drive source.

3. The apparatus according to claim 2, wherein the drive force transmission gearing comprises at least one rotor, wherein the at least one rotor transmits the force of the common drive source selectively to the lancet drive, the device for advancing the magazine, and the device for generating the sample transfer movement as a function of a rotational angle.

4. The apparatus according to claim 2, wherein the force required for piercing, advancing the magazine, and sample transfer is generated from rotational movement around a common axis.

5. The apparatus according to claim 1, wherein the magazine is a circular ring.

6. The apparatus according to claim 1, wherein the magazine comprises a plurality of chambers positioned in a radial direction and wherein each chamber contains one lancet.

7. The apparatus according to claim 1, wherein the integrated drive unit further comprises:

a drive rotor, wherein the drive rotor is rotatable around a rotational axis positioned perpendicularly to the piercing axis in the housing;

a spring, wherein the spring drives the drive rotor;

a tensioning rotor, wherein the tensioning rotor is rotatable coaxially to the drive rotor and is connected to the drive spring so that the drive spring is tensioned by rotating the tensioning rotor in relation to the drive rotor;

a first cam control, wherein the first cam control converts the rotation of the drive rotor into a radial forward and reverse movement of the lancet along the piercing axis;

a stepping switch mechanism having a second cam control, wherein the second cam control converts the rotational movement of the tensioning rotor into a linear movement for advancing the magazine; and

a sample transfer device having a third cam control, wherein the third cam control converts the rotational movement of the tensioning rotor into a linear movement of a pressure tappet essentially perpendicular to the piercing axis.

8. The apparatus according to claim 7, wherein the rotational axis of the magazine is positioned parallel to the rotational axis of the drive rotor.

9. The apparatus according to claim 7, wherein the tensioning rotor is flat circular disk with a central pot-like recess.

10. The apparatus according to claim 9, wherein the drive rotor is seated in the central pot-like recess.

11. The apparatus according to claim 7, wherein the drive rotor has a control groove on a front side, wherein the central groove is traveled by a groove rider, in order to convert the rotational movement of the drive rotor into a radial movement.

12. The apparatus according to claim 11, further comprising:

an one-armed transmission lever pivotally mounted in the housing, wherein the one-armed transmission lever comprises a free end connected to the drive rod; and

the groove rider positioned on the transmission lever between the free end and a lever axis, wherein the lever axis of a transmission ratio extends parallel to the rotational axis of the drive rotor and is displaceable transversely to the piercing axis and wherein the transmission ratio of the lever is settable.

13. The apparatus according to claim 7, wherein the drive rotor and the tensioning rotor are connectable in a rotationally-fixed manner.

14. The apparatus according to claim 7, wherein the stepping switch mechanism comprises:

a switching cam provided on the tensioning rotor, wherein the switching cam actuates a link slide upon being traveled over;

a switching link moved by the link slide; and

switching elements, wherein the switching elements are positioned on an outer side of the magazine and wherein the switching elements engage in the switching mechanism in order to convert a radial movement of the link slide into a limited rotational movement of the magazine.

15. The apparatus according to claim 7, wherein the tensioning rotor has an edge ramp on which a friction element travels down in order to convert the rotational movement of the drive rotor into a movement perpendicular to the piercing axis.

16. A lancet coupling mechanism for an apparatus according to claim 1, the lancing coupling mechanism comprises at least one chamber that extends in the direction of the piercing axis and comprises a lancet, a drive rod that penetrates into the chamber and is coupled to the lancet to execute a controlled forward and reverse movement along the piercing axis, wherein

the lancet is elastically bendable around at least one bending axis extending transversely to the piercing axis;

the chamber comprises a shaft adapted to the cross section of the lancet, wherein the shaft has at least one curvature around an axis transverse to the piercing axis; and

the drive rod is coupled to the lancet when the lancet is in the bent state, wherein the drive rod has a formfitting connection to the lancet when the lancet is in a relaxed state.

17. The lancet coupling mechanism according to claim 16, wherein the lancet has at least one coupling recess.

18. The lancet coupling mechanism according to claim 17, wherein the drive rod has at least one coupling structure on a front end, wherein coupling structure extends perpendicularly to the bending axis of the lancet and engages in a coupling recess of the bent lancet when the lancet moves forward.

19. The lancet coupling mechanism according to claim 17, wherein the lancet is manufactured from a piece of level flat sheet metal.

20. The lancet coupling mechanism according to claim 17, wherein the lancet has at least one eye in the area of a rear end of the lancet.

21. The lancet coupling mechanism according to claim 20, wherein the drive rod has at least one hook on the front end, wherein the at least one hook hooks in the eye of the lancet.