Test system for measuring the concentration of an analyte in a body fluid

• US 8,114,029 B2
• Filed: 11/16/2009
• Issued: 02/14/2012
• Est. Priority Date: 05/29/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Haar, Hans-Peter, Meacham, George Bevan Kirby
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): BECKER, CHARLES BARTON
• Application Number:
  US12/619,384
• Publication Number:
  US 20100094172A1
• Time in Patent Office: 820 Days
• Field of Search: 600/583, 600/584, 606/181, 606/182, 606/183, 606/184, 606/185, 606/186, 606/187, 606/188, 606/189
• US Class Current: 600/583
• 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 5/150419 comprising means for capillary action
• CPC Class Codes: A61B 5/150511 Details of construction of shaft
• CPC Class Codes: A61B 5/15107 Piercing being assisted by a triggering mechanism
• 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 5/15146 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 5/15151 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
• CPC Class Codes: A61B 5/15176 Stocking means comprising cap, cover, sheath or protection for aseptic stocking

Abstract

An actuator for driving a test element is disclosed. The test element can comprise a lancet for perforating the skin of a living organism. The actuator can comprise an engaging part for engaging and driving the test element in a lancing motion. The actuator can further comprise a lancing actuator and a lancing spring. The lancing actuator can bias the lancing spring by executing a forward movement and thereby can exert a biasing force on the engaging part. The actuator can further comprise a latch element. The latch element can be a force-sensitive latch element for exerting a retention force to hold back the engaging part. The retention force can counteract the biasing force. The latch element can release the engaging part when the biasing force exerted by the lancing actuator exceeds the retention force exerted by the latch element, thereby allowing the test element to perform the lancing motion.

Claims

1. An actuator for driving a test element, the test element comprises a lancet for perforating a skin portion of a living organism and the actuator comprising:

an engaging part for engaging and driving the test element to perform a lancing motion;

a lancing spring;

a lancing actuator, wherein the lancing actuator biases the lancing spring by executing a forward movement and thereby exerting a spring biasing force on the engaging part; and

a latch element, wherein the latch element is force-sensitive and exerts a magnetic retention force to hold back the engaging part that is parallel to the spring biasing force, wherein the magnetic retention force counteracts the spring biasing force, and wherein the latch element releases the engaging part when the spring biasing force exerted by the lancing actuator exceeds the magnetic retention force exerted by the latch element, thereby allowing the test element to perform the lancing motion.

2. The actuator according to claim 1, wherein the engaging part comprises,

a fast shuttle element, wherein the fast shuttle element engages the test element and is held back by the latch element;

and

a slow shuttle element, wherein the slow shuttle element is engaged by the lancing actuator, and wherein the lancing spring extends between the fast shuttle element and the slow shuttle element.

3. The actuator according to claim 1, wherein the latch element comprises a mechanical detent.

4. The actuator according to claim 1, wherein the latch element comprises a magnetic switch element.

5. The actuator according to claim 4, wherein the magnetic switch element comprises,

a magnetic element exerting an attractive magnetic force on the engaging part, wherein the release of the engaging part is initiated as soon as the lancing force exceeds the attractive magnetic force.

6. The actuator according to claim 1, wherein the position of the latch element in the direction of the lancing force is adjustable allowing for a penetration depth of the lancing motion of the test element to be adjusted.

7. The actuator according to claim 6, further comprising a stroke adjustment screw allowing for adjustment of the position of the latch element.

8. The actuator according to claim 1, wherein the engaging part comprises a gripper for gripping a portion of the test element.

9. The actuator according to claim 8, wherein the gripper comprises

a first gripper element;

and

a second gripper element, wherein the first and second gripper elements are biased by a coupling spring to exert a clamping force, wherein the actuator further comprises an abutment portion, wherein the actuator dislocates the first and second gripper elements by retracting the gripper and pressing one of the grippers against the abutment portion, thereby compressing the coupling spring and opening the gripper.

10. The actuator according to claim 9, wherein the actuator closes the gripper by a forward movement of the lancing actuator.

11. The actuator according to claim 8, wherein the actuator at least partly transforms a linear motion of the lancing actuator into a gripping motion of the gripper.

12. The actuator according to claim 8, wherein the engaging part comprises

a pivotable portion comprising the gripper, and wherein the actuator pivots the gripper into engagement with the test element by a forward movement of the lancing actuator and pivots the gripper out of engagement with the test element by a rearward movement of the lancing actuator.

13. The actuator according to claim 12, wherein the pivotable portion is biased into engagement with the test element by a lift spring.

14. The actuator according to claim 8, wherein the actuator at least partly transforms a first linear motion of the lancing actuator into a second linear motion of the gripper, wherein the second linear motion of the gripper at least contains a directional component perpendicular to the first linear motion.

15. The actuator according to claim 1, wherein the engaging part comprises an electrical connection for electrically contacting the test element.

16. The actuator according to claim 1, wherein the actuator detects if a first lancing motion resulted in acquiring of a body fluid sample from the living organism, wherein the actuator re-iterates the lancing motion with an increased penetration depth if no or insufficient body fluid is acquired.

17. A test system for measuring the concentration of one or more constituents in a body fluid of a living organism, wherein the test system comprises an actuator according to claim 1 and at least one test element, wherein the test element comprises a lancet for perforating a skin portion of a living organism.

18. The test system according to claim 17, wherein the test element further comprises a capillary transport system for acquiring a body fluid sample from the living organism.

19. The test system according to claim 17, wherein the test system further comprises

a magazine comprising at least one test element, at least one compartment comprising a test element and at least one barrier to preserve sterility of the test element and to exclude environmental contaminants;

and

an opening mechanism to open the barrier of the compartment of the test element prior to perforating the skin portion of the living organism.

20. The test system according to claim 19, wherein the opening mechanism is actuated by the lancing actuator.

21. The test system according to claim 19, wherein the opening mechanism opens the barrier in at least one lancing portion allowing for the test element to perform the lancing motion without getting into contact with the shielding.

22. The test system according to claim 21, wherein the opening mechanism further opens the barrier in at least one engagement portion, wherein the engagement portion allows for the engaging part to engage the test element.

23. The test system according to claim 19, wherein the magazine comprises a magazine disk of an substantially round shape, wherein the disk comprises a plurality of test elements in an essentially radial arrangement, such that the lancet of the test elements are pointing towards the outer diameter of the disk.

24. The test system according to claim 23, wherein the test system further comprises

a rotating unit for rotating the magazine disk into a sampling position with respect to a pre-selected test element, wherein in the sampling position the test system drives the actuator in order to perform the lancing motion of the pre-selected test element.

25. The test system according to claim 17, wherein the test element comprises at least one hydrophilic coating.