Portable device for the measurement and control of analytes in biological fluids

• US 8,273,228 B2
• Filed: 12/06/2007
• Issued: 09/25/2012
• Est. Priority Date: 12/07/2006
• Status: Active Grant

• Current Assignee: A Menarini Industrie Farmaceutiche Riunite SRL
• Original Assignee: A Menarini Industrie Farmaceutiche Riunite SRL
• Inventors: Dall'Oglio, Giorgio, Valgimigli, Francesco
• Primary Examiner(s): Olsen, Kaj K
• Assistant Examiner(s): LEONG, SUSAN DANG
• Application Number:
  US11/999,916
• Publication Number:
  US 20080149478A1
• Time in Patent Office: 1,755 Days
• Field of Search: 435 4- 4052, 4352871-2887, 20440301-40315, 204518-545, 204627-640, 205/777.5, 205/778, 205/792, 600309-367
• US Class Current: 204/403.01
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors

Abstract

Portable device for the measurement and control of analytes in biological fluids, provided with biosensor for measurement and control of biological fluids such as glucose and other analytes characterized by the possibility of using electrolytic cells with two, three or more electrodes, with polarization voltage between a few millivolts and 100 millivolts; the possibility of measuring the fluid temperature at the outlet of the electrolytic cell in high resolution mode for diagnostic purposes, hence it can also be used for performing very accurate thermal compensation of the electrochemical measurement; the possibility of performing optimised correction of both the systematic and random errors in the measurement performed; the possibility of calibrating the sensors used more accurately and efficiently and, lastly, the possibility of performing the measurement with much lower polarization voltages at the electrodes than the equipment in the state of the art with consequent benefits in terms of reduced wear of the electrodes used and reduced susceptibility to electrochemical interferences in the measuring phase.

Claims

1. Portable device for the measurement and control of analytes in biological fluids comprising:

one disposable measuring cell suitable for application to the patient'"'"'s skin, comprising in turn a subcutaneous probe, an enzymatic cell combined with said subcutaneous probe by means of an appropriate hydraulic connection, a thermal sensor combined with a first capillary tube at the outlet of said enzymatic cell and comprising an electro-fluidic wiring adapted to transmit fluids and electrical signals, an element containing a glucose sample for functional verification of the system before insertion of the subcutaneous probe, an air bubble separator;

one measuring unit combined with said measuring cell and one remote control unit combined with said measuring cell and with said measuring unit and suitable for setting, adjusting and monitoring the measurement, wherein said disposable measuring cell is external to said measuring unit connected to said measuring unit by means of said electro-fluidic wiring and adapted to be placed attached to the subcutaneous probe and to the patient'"'"'s skin.

2. Device as claimed in claim 1 wherein said measuring unit comprises:

a first tank combined with a hydraulic unit;

a pressure meter combined with a second capillary tube and suitable for assessing the delivery pressure into said measuring cell;

a second tank suitable for receiving said sample of interstitial liquid from said second capillary tube after the measurement has been performed;

a control module with microprocessor, suitable for managing the sequence of measuring and recording operations and the bidirectional communication of commands, measurements and programmes via radio towards the outside and in particular towards said remote control unit;

a power supply battery.

3. Device as claimed in claim 1 wherein said hydraulic unit comprises pumping means suitable for conveying the solution contained in said first tank into the subcutaneous area of the patient through said measuring cell.

4. Device as claimed in claim 1 wherein said microprocessor control module is connected to said thermal sensor and to an enzymatic cell by means of appropriate electrical connections forming part of said electro-fluidic wiring and to a pressure meter by means of an appropriate electrical connection.

5. Device as claimed in claim 3 wherein said pumping means comprise a pump for example of the mechanical type—

syringe or peristaltic—

or a diaphragm or piezoelectric pump.

6. Device as claimed in claim 1 wherein said enzymatic cell comprises:

a reaction chamber provided with an inlet and an outlet and in turn comprising inside an enzymatic biosensor.

7. Device as claimed in claim 6 wherein said enzymatic biosensor is of the three or two electrode type.

8. Device as claimed in claim 1 wherein said probe comprises an appropriate guide needle.

9. Device as claimed in claim 1 wherein said measuring unit is provided with appropriate means for anchoring to the patient'"'"'s body.

10. Device as claimed in claim 1 wherein said remote unit comprises an appropriate display suitable for displaying the measurements performed in real time in both numerical and graphic form.

11. Device as claimed in claim 1 wherein said air bubble separation device is produced by means of a chamber with two special membranes one of which permits, at the working pressures, passage of the liquid along the fluidic line but separation of the bubbles, while the other permits outflow of the air accumulated in the chamber but not that of the perfusion liquid.