Control device for a medical test system

Patent metadata

Field	Value
Publication number	US-9289162-B2
Application number	US-201213365404-A
Country	US
Kind code	B2
Filing date	Feb 3, 2012
Priority date	Aug 4, 2009
Publication date	Mar 22, 2016
Grant date	Mar 22, 2016

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.

First claim

What is claimed is:

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.

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 arran

Assignees

• Kuhr Hans-Juergen
• Harttig Herbert
• Haar Hans-Peter
• List Hans
• Roche Diabetes Care Inc

Inventors

• Kuhr Hans-Juergen
• Harttig Herbert
• Haar Hans-Peter
• List Hans

Classifications

• A61B5/1411 Primary

  by percutaneous method, e.g. by lancet · CPC title

• A61B5/14532 Primary

  for measuring glucose, e.g. by tissue impedance measurement · CPC title

• A61B5/157

  {Devices} characterised by integrated means for measuring characteristics of blood · CPC title

• A61B5/15186

  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 title

• A61B5/1459

  invasive, e.g. introduced into the body by a catheter · CPC title