Control device for a medical test system

• US 9,289,162 B2
• Filed: 02/03/2012
• Issued: 03/22/2016
• Est. Priority Date: 08/04/2009
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Kuhr, Hans-Juergen, Harttig, Herbert, List, Hans, Haar, Hans-Peter
• Primary Examiner(s): Dougherty, Sean
• Assistant Examiner(s): CERIONI, DANIEL LEE
• Application Number:
  US13/365,404
• Publication Number:
  US 20120165698A1
• Time in Patent Office: 1,509 Days
• Field of Search: 600/573, 600/583
• US Class Current: 1/1
• 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 5/1459 invasive, e.g. introduced into the body by a catheter A61B5/1464 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 5/150419 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 5/150946 Means for varying, regulating, indicating or limiting the speed or time of blood collection
• 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 5/1513 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 5/15186 Devices loaded with a single lancet, i.e. a single lancet with or without a casing is loaded into a reusable drive device and then discarded after use; drive devices reloadable for multiple use
• CPC Class Codes: A61B 5/1519 comprising driving means, e.g. a spring, for propelling the piercing unit
• CPC Class Codes: A61B 5/15194 fully automatically retracted, i.e. the retraction does not require a deliberate action by the user, e.g. by terminating the contact with the patient's skin
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood

Abstract

The invention concerns a control device for a medical test system which has a lancing element that can be inserted into body tissue to collect body fluid and a lancing drive for the lancing element. A sensor element for body fluid is arranged on the lancing element and a control unit is coupled to the sensor element for detecting a fault when collecting body fluid. In order to improve the success rate, the control unit actuates the lancing drive for an automatic puncture repetition in less than 1 second when a fault, e.g., inadequate wetting of a detection field, occurs.

Claims

1. A medical test system, comprising:

a lancing element that can be inserted into body tissue to collect body fluid;

a lancing drive for the lancing element;

a sensor element for body fluid, the sensor element being arranged on the lancing element and generating a control signal responsive to the presence of body fluid wherein the control signal indicates whether body fluid is present or absent; and

a control unit coupled to the sensor element, the control unit configured for detecting the control signal, the control unit further programmed to determine whether a sufficient amount of body fluid has been collected or a fault in the collection of body fluid has occurred;

wherein, when a fault in the collection of body fluid is determined to have occurred by the control unit after a first reciprocating lancing movement, the control unit actuates the lancing drive in an automatic second reciprocating lancing movement, the first and second reciprocating lancing movements having a repetition interval of less than 1 second, and wherein the repetition interval defines a non-zero time period beginning with initiation of the first reciprocating lancing movement and concluding with initiation of the second reciprocating lancing movement;

when the control unit determines that a sufficient amount of body fluid has been collected after the first reciprocating lancing movement, the body fluid is evaluated by the control unit without conducting a second reciprocating lancing movement; and

when the control unit actuates the lancing drive in an automatic second reciprocating lancing movement, the control unit makes a second determination whether a sufficient amount of body fluid has been collected or a fault in the collection of body fluid has occurred after the passage of a second non-zero time period following the second reciprocating lancing movement and wherein the control unit evaluates the body fluid if the second determination finds that a sufficient amount of body fluid has been collected after the second reciprocating lancing movement and wherein the control unit generates an error message if the second determination finds that a fault in the collection of body fluid has occurred after the second reciprocating lancing movement.

2. The medical test system of claim 1, wherein the repetition interval is less than 700 ms.

3. The medical test system of claim 1, wherein the repetition interval is less than 500 ms.

4. The medical test system of claim 1, wherein the sensor element is fluidly connected to a section of a collecting channel for body fluid formed on the lancing element.

5. The medical test system of claim 1, wherein the control signal changes discontinuously in reflectance when the sensor element is wetted with body fluid.

6. The medical test system of claim 5, wherein the discontinuous change in reflectance comprises a step-change.

7. The medical test system of claim 1, wherein the sensor element is connected to the control unit by at least one signal conductor during the lancing movement of the lancing element.

8. The medical test system of claim 7, wherein the at least one signal conductor comprises a light guide.

9. The medical test system of claim 1, wherein the sensor element has two or more detection areas arranged spaced apart from one another to detect a two-dimensional load of body fluid.

10. The medical test system of claim 1, wherein the fault comprises the control unit determining an absence of wetting or an inadequate wetting of the sensor element with body fluid.

11. The medical test system of claim 1, further comprising a switch which can be used by a user to deactivate the control unit.

12. The medical test system of claim 1, wherein the control unit has a control loop which automatically adapts lancing parameters for the second lancing movement.

13. The medical test system of claim 1, wherein the lancing drive has an energy store dimensioned for multiple punctures.

14. The medical test system of claim 1, wherein the lancing drive has several energy stores each individually dimensioned for a respective single puncture.

15. The medical test system of claim 1, wherein the lancing drive has a brushless direct current motor that can be temporarily subjected to an overcurrent.

16. The medical test system of claim 1, wherein the sensor element has a detection field for a component of the body fluid, and wherein the component as well as the wetting state of the detection field with body fluid can be detected by a unitary measuring unit.

17. The medical test system of claim 1, wherein the lancing element has a collecting volume of less than 100 nl.

18. The medical test system of claim 1, wherein the lancing element has a capillary collecting channel to transfer the body fluid onto the sensor element in a transfer time of less than 0.3 s after skin puncture.

26. The medical test system of claim 1, wherein the first reciprocating lancing movement is adapted to puncture the body tissue.

19. A method of using a test system of the type having a lancing element that can be inserted into body tissue to collect body fluid and a lancing drive for driving the lancing element in a reciprocating puncture movement, the method comprising:

driving the lancet in an initial reciprocating puncture movement with the lancing drive to puncture the body tissue;

collecting body fluid with the lancet after the initial reciprocating puncture movement;

using a sensor of the lancet to detect body fluid that has been collected with the lancet after the initial reciprocating puncture movement;

using a control unit that is connected to the sensor to determine whether a sufficient amount of body fluid has been collected or a fault in collecting body fluid has occurred after the initial reciprocating puncture movement;

wherein, when a fault is determined to have occurred after the initial reciprocating puncture movement by the control unit, driving the lancet in a second reciprocating puncture movement, the initial and second reciprocating puncture movements having a repetition interval of less than 1 second, and wherein the repetition interval defines a non-zero time period beginning with initiation of the initial reciprocating puncture movement and concluding with initiation of the second reciprocating puncture movement;

when the control unit determines that a sufficient amount of body fluid has been collected after the initial reciprocating puncture movement, the body fluid is evaluated by the control unit without conducting a second reciprocating puncture movement; and

when the lancet is driven in a second reciprocating puncture movement, the control unit determines whether a sufficient amount of body fluid has been collected or a fault in collecting the body fluid has occurred after the second reciprocating puncture movement and, when the control unit determines that a sufficient amount of body fluid has been collected after the second reciprocating puncture movement, the body fluid is evaluated by the control unit and, when the control unit determines that a fault has occurred after the second reciprocating puncture movement, the control unit generates an error message.

20. The method of claim 19, wherein the repetition interval is less than 700 ms.

21. The method of claim 19, wherein the repetition interval is less than 500 ms.

22. The method of claim 19, further comprising generating a control signal that changes discontinuously in reflectance when a detection field of the sensor is wetted with body fluid.

23. The method of claim 19, further comprising arranging two or more detection fields spaced apart from one another to detect a two-dimensional load of body fluid.

24. The method of claim 19, further comprising, before the second reciprocating puncture movement, automatically adapting lancing parameters for the second reciprocating puncture movement.

25. The method of claim 19, wherein the step of determining a fault comprises determining inadequate wetting of a detection field of the sensor.

27. The method of claim 19, wherein, when the sensor detects an insufficient collection of body fluid, the control unit determines that a fault has occurred.