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

• US 20080149478A1
• Filed: 12/06/2007
• Published: 06/26/2008
• 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: Valgimigli, Francesco, Dall'Oglio, Giorgio
• Granted Patent: US 8,273,228 B2
• Time in Patent Office: Days
• US Class Current: 204/403.02
• 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 comprising: one disposable measuring cell suitable for application to the patient'"'"'s skin, one measuring unit combined with said measuring cell by means of an electro-fluidic wiring and one remote control unit combined with said measuring cell and with said measuring unit and suitable for setting, adjusting and monitoring the measurement.

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, one measuring unit combined with said measuring cell by means of an electro-fluidic wiring and one remote control unit combined with said measuring cell and with said measuring unit and suitable for setting, adjusting and monitoring the measurement.

2. Device as claimed in claim 1 wherein said measuring cell comprises 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 comprised in said electro-fluidic wiring;

an element containing a glucose sample for functional verification of the system before insertion of the subcutaneous probe;

an air bubble separator.

3. 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.

4. 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.

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

6. Device as claimed in claim 4 wherein said pumping means comprise a pump for example of the mechanical type—

syringe or peristaltic—

or a diaphragm or piezoelectric pump.

7. Device as claimed in claim 2 wherein said enzymatic cell comprises:

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

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

9. Device as claimed in claim 2 wherein said probe comprises an appropriate guide needle.

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

11. 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.

12. Device as claimed in claim 2 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.

13. Device for filtering air bubbles in measuring cells of devices for the measurement and control of analytes in biological fluids, wherein it comprises 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.