Diagnostic methods and systems based on urine analysis

• US 10,362,981 B2
• Filed: 06/30/2014
• Issued: 07/30/2019
• Est. Priority Date: 08/23/2007
• Status: Active Grant

• Current Assignee: Flowsense Ltd.
• Original Assignee: Flowsense Ltd.
• Inventors: Paz, Ilan, Jackson, Martin Clive Henry, Chimes, Stanley
• Primary Examiner(s): Dougherty, Sean P
• Assistant Examiner(s): Kolderman, Nicholas E
• Application Number:
  US14/319,585
• Publication Number:
  US 20140316219A1
• Time in Patent Office: 1,856 Days
• CPC Class Codes: A61B 10/007 for taking urine samples measuring urological functions A61B5/20; genital receptacles A61F5/451; urinals for bed-ridden persons A61G9/006
• CPC Class Codes: A61B 5/14507 specially adapted for measuring characteristics of body fluids other than blood devices for taking samples of body liquids A61B10/0045
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/201 Assessing renal or kidney functions
• CPC Class Codes: A61B 5/208 adapted to determine urine quantity, e.g. flow, volume
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/486 Bio-feedback A61B5/375 takes precedence
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: G01N 33/493 urine

Abstract

A method for diagnosing a body malfunction is provided. At least one change in urinary parameter values, being indicative of the body malfunction, is monitored and detected. A volumetric urinary output of kidneys is monitored using a urine flow monitoring apparatus having a low flow metering device. It is determined whether a change exists in at least one of a volume value of the volumetric urinary output, and a trend of the corresponding urinary parameter value during a predetermined period. Signals are received from a plurality of electrodes, representing the urinary parameter values. The body malfunction is detected based on the determination of the change in at least one of the volume value and the trend.

Claims

1. A computer-implemented method for diagnosing a body malfunction, the method comprising:

monitoring and detecting at least one change in urinary parameter values, the at least one change being indicative of the body malfunction, wherein one of the urinary parameter values comprises an oxygen level in the urine;

monitoring a volumetric urinary output of kidneys using a urine flow monitoring apparatus having a low flow metering device with a microprocessor, wherein the urine flow monitoring device further comprises a negative pressure tube which provides a continuous flow of urine through at least a portion of the urine flow monitoring apparatus;

determining, using the microprocessor, whether a change exists in a volume value of the volumetric urinary output and a trend of the corresponding urinary parameter value during a predetermined period;

receiving signals from a plurality of electrodes connected to the urine flow monitoring apparatus, the signals representing the urinary parameter values;

comparing, using the microprocessor, at least two occurrences of the trend of the received signals at an identical iteration during the predetermined period;

measuring, using the microprocessor, whether the change of the trend in at least two consecutive time periods exceeds a predetermined threshold in the urinary parameter values received from at least one of the plurality of electrodes; and

detecting, using the microprocessor, the body malfunction based on the determination of the change in the volume value of the volumetric urinary output, and the compared trend change of the corresponding urinary parameter value detected by the received signals during the predetermined period,

wherein the oxygen level is detected with an electrode from the plurality of electrodes.

2. The method of claim 1, further comprising evaluating the change in at least one of the volume value and the trend based on predetermined diagnosis information.

3. The method of claim 1, further comprising generating an alarm signal using an alarm device connected to the microprocessor based on the determination of the change in at least one of the volume value and the trend.

4. The method of claim 1, further comprising performing a corrective action based on the determination of the change in at least one of the volume value and the trend.

5. The method of claim 1, further comprising serially inspecting each urinary parameter value until all urinary parameter values are examined.

6. The method of claim 1, further comprising serially inspecting each urinary parameter trend until all urinary parameter trends are examined.

7. The method of claim 1, further comprising:

connecting the urine flow monitoring apparatus between a catheter and a connector; and

connecting the connector between the catheter and a urine collection vessel.

8. The method of claim 1, wherein the low flow metering device incorporates a drop generator and a droplet counter.

9. The method of claim 1, further comprising storing information related to the at least one change in urinary parameter values in memory of a computer system connected to the low flow metering device.

10. The method of claim 1, further comprising comparing the volumetric urinary output at different predetermined times.

11. The method of claim 1, further comprising continuously monitoring at least one of analyte concentrations, analyte quantities, and trends in changes of the analyte concentrations during a predetermined period.

12. The method of claim 1, further comprising taking a reading of the urinary parameter values either at least once a minute or at least once every five minutes.

13. The method of claim 1, further comprising comparing a newly acquired value with a previous value of a corresponding urinary parameter value.

14. The method of claim 1, further comprising logging a trend of the urinary parameter values over a predetermined time interval.

15. The method of claim 1, further comprising displaying a trend of the urinary parameter values over a predetermined time interval using a display screen.