Point of care urine analyzer

• US 10,638,966 B2
• Filed: 08/04/2016
• Issued: 05/05/2020
• Est. Priority Date: 08/05/2015
• Status: Active Grant

• Current Assignee: Art Healthcare Ltd.
• Original Assignee: Art Healthcare Ltd.
• Inventors: Elia, Liron, Iddan, Gavriel J.
• Primary Examiner(s): Dougherty, Sean P
• Assistant Examiner(s): Melhus, Benjamin S
• Application Number:
  US15/228,115
• Publication Number:
  US 20170035342A1
• Time in Patent Office: 1,370 Days
• Field of Search: None
• CPC Class Codes: A61B 2562/0295 Strip shaped analyte sensors for apparatus classified in A61B5/145 or A61B5/157 disposable multilayered or laminated electrodes G01N27/307; details of handling chemical test elements G01N33/4875
• 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 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/1468 using chemical or electrochemical methods, e.g. by polarographic means A61B5/1486 takes precedence
• 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 5/743 Displaying an image simultaneously with additional graphical information, e.g. symbols, charts, function plots
• 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: A61B 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61M 25/0017 specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
• CPC Class Codes: G01J 3/28 Investigating the spectrum using colour filters G01J3/51
• CPC Class Codes: G01N 2021/052 Tubular type; cavity type; multireflective
• CPC Class Codes: G01N 2021/8564 Sample as drops

Abstract

There is provided a urine analysis device for bed side monitoring of a patient, comprising: an inlet sized and shaped for fluid communication with a urine collecting tube that receives urine from a patient; a drip chamber through which the urine flows towards an outlet; at least one sensor that analyzes each drop of urine and estimates a respective volume of each drop; a timing element that measures a reference time for each drop; a program store storing code; and at least one processing unit coupled to the program store for implementing the stored code, the code comprising: code to calculate a urine output flow rate of the urine output flowing through the chamber according to the estimated volume of each drop of the urine and the reference time for each drop; and code to output the urine output flow rate.

Claims

1. A urine analysis device for bed side monitoring of a patient, comprising:

an inlet sized and shaped for fluid communication with a urine collecting tube that receives urine from a patient;

a drip chamber through which the urine flows towards an outlet;

at least one illuminating source for illuminating each respective individual drop of a plurality of drops of urine during fall of the respective individual drop through said drip chamber, said illuminating source is adapted to project light in a perpendicular direction to a falling direction of the respective individual drop;

a sensor that captures only a single image of said each respective individual drop of the plurality of drops during fall of the respective individual drop through said drip chamber upon being triggered by a triggering signal indicating a detection of each respective individual drop of the plurality of drops during fall of the respective individual drop through said drip chamber, wherein said sensor comprises a camera positioned on an opposite side of said drop chamber from said illuminating source;

a photo detector disposed above said sensor, said photo detector generates said triggering signal upon said detection of each respective individual drop of the plurality of drops during fall of the respective individual drop through said drip chamber;

a program store storing code; and

a hardware processor coupled to the program store for implementing the stored code, the code comprising;

code to estimate a volume of said each respective individual drop of the plurality of drops during fall of the respective individual drop through said drip chamber by analyzing said only single image to calculate a plurality of cross sectional areas for a plurality of different parts of the respective individual drop;

code to continuously calculate a urine output flow rate of the urine output flowing through the chamber according to the estimated volume of each respective individual drop of the plurality of drops and sum a total volume of the plurality of drops per time interval;

code to continuously calculate and update in real-time, at bedside, a trend in said urine output flow rate by conducting a regression analysis on a plurality of calculated urine output flow rates of said patient;

code to predict a future urine output flow rate based on said continuously calculated trend;

code to output the urine output flow rate, said calculated trend and said predicted future output flow rate to be dynamically displayed in real-time; and

code to calculate instructions to control a feeding rate according to the urine output flow.

2. The urine analysis device of claim 1, further comprising code to identify when said trend in the urine output flow rate is indicative of a decrease or increase in the urine output flow rate and to present an indication of the trend on a graphical user interface (GUI) presented on a display.

3. The urine analysis device of claim 1, further comprising code to identify when said trend in the urine output flow rate is indicative of potential acute kidney injury (AKI) and to present an indication of the detected AKI on a graphical user interface (GUI).

4. The urine analysis device of claim 1, further comprising code to generate an alert when said predicted future urine output flow rate is predictive of a future urine flow rate value falling outside of a predefined tolerance range.

5. The urine analysis device of claim 1, wherein the code includes instructions to calculate an instantaneous urine output flow rate, and present the instantaneous urine output flow rate on a graphical user interface (GUI).

6. The urine analysis device of claim 1, further comprising an interface to a display, and code including instructions for presentation of a graphical user interface (GUI) on the display that includes the measured urine output flow rate and an identified trend in the urine output flow rate.

7. The urine analysis device of claim 1, wherein the sensor analyzes urine flowing within the drip chamber, prior to the flowing urine entering a urine collection bag in fluid communication with the outlet.

8. The urine analysis device of claim 1, wherein the camera is a fast gated camera and is activated by said triggering signal generated by said photo detector.

9. The urine analysis device of claim 1, further comprising code to calculate a liquid content type of the respective individual the drop of the plurality of drops of urine by comparing said only a single image of the respective individual drop to an image of each of a plurality of exemplary drops, wherein each of said image of the respective individual drop and said image of each of said plurality of exemplary drops is formed by combining a plurality of time sequentially ordered calculated values of widths of the respective individual drop or one of the plurality of exemplary drops;

wherein each of the plurality of exemplary drops is made of a different one of a plurality of liquid content types; and

wherein the respective individual drop of the plurality of drops of urine is calculated to be of one of said plurality of the liquid content types according to said comparison.

10. The urine analysis device of claim 1, wherein the drip chamber is transparent, and wherein the sensor comprises an optical sensor for estimating the volume of each respective individual drop of the plurality of drops through the walls of the transparent drip chamber.

11. The urine analysis device of claim 10, wherein the drip chamber is detachable.

12. The urine analysis device of claim 1, further comprising a drip formation element for forming said urine received through said inlet into single sequentially falling drops.

13. The urine analysis device of claim 12, wherein said drip formation element is designed to form said single sequentially falling drops in a rate that matches a urine flow rate of said received urine from said patient.

14. The urine analysis device of claim 1, wherein said regression analysis is conducted using a least square regression analysis and a sliding time window of a predefined number of calculated urine output flow rates.

15. The urine analysis device of claim 1, wherein said sensor estimates said respective volume of each respective individual drop of the plurality of drops by converting said single image of the respective individual drop to a binary image by processing said at least one image using a binary filter.

16. The urine analysis device of claim 1, wherein said estimating the volume of each respective individual drop of the plurality of drops of urine is by summing a plurality of volumes, each volume of a plurality of volumes being one of a plurality of horizontal planar segments of the respective individual drop, wherein each of said plurality of volumes is calculated by measuring an electromagnetic radiation (EMR) captured within said single image, in a restricted horizontal planar area during a sequence of time intervals, wherein when the respective individual drop falls, in each time interval a different horizontal segment of the respective individual drop interferes with a portion of said EMR reaching the restricted horizontal planar area.

17. The urine analysis device of claim 1, wherein the instructions to control the feeding rate of the feeding device according to the estimated urine output flow comprises instructions to increase or decrease the feeding rate.

18. The urine analysis device of claim 1, further comprising code to calculate instructions to control the feeding device according to the estimated urine output flow to treat the patient for preventing deterioration and/or disease progression.

19. The urine analysis device of claim 1, wherein the instructions to control the feeding rate of the feeding device according to the estimated urine output flow comprises instructions to control the feeding rate of at least one member selected from the group consisting of:

diuretic, and fluids.

20. The urine analysis device of claim 1, further comprising code to:

detect each respective individual drop of the plurality of drops of urine during free fall in said drip chamber;

generate a time stamp for each detected respective individual drop;

trigger the sensor for capturing only the single image of each respective individual drop during free fall by the detection of the respective individual drop;

and compute the urine output flow rate and/or trend of said urine output flow rate based on multiple time sequentially ordered calculated values of widths of each respective individual drop.