Apparatus and method for bedside collection of body fluids and automatic volume level monitoring

• US 9,074,920 B2
• Filed: 06/01/2010
• Issued: 07/07/2015
• Est. Priority Date: 06/03/2009
• Status: Active Grant

• Current Assignee: Biometrix, Ltd. (Q Holding Company)
• Original Assignee: Biometrix, Ltd. (Q Holding Company)
• Inventors: Mendels, Yair, Revzin, Ilya, Manny-Aframian, Vered, Rubinstein, Eldad Gabriel
• Primary Examiner(s): Towa, Rene
• Assistant Examiner(s): ABOUELELA, MAY A
• Application Number:
  US13/375,693
• Publication Number:
  US 20120078137A1
• Time in Patent Office: 1,862 Days
• Field of Search: 600/573, 600/574, 600/575, 600/576, 600/579, 600/580, 600/581, 600/582, 600/584
• US Class Current: 1/1
• 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 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/153 Devices specially adapted for taking samples of venous or arterial blood, e.g. with syringes
• CPC Class Codes: A61B 5/155 Devices specially adapted for continuous or multiple sampling, e.g. at predetermined intervals devices loaded with multiple lancets simultaneously A61B5/15146
• CPC Class Codes: A61B 5/157 Devices characterised by integrated means for measuring characteristics of blood
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure
• CPC Class Codes: A61B 5/208 adapted to determine urine quantity, e.g. flow, volume
• CPC Class Codes: G01F 23/18 Indicating, recording or alarm devices actuated electrically
• CPC Class Codes: G01F 23/2921 for discrete levels
• CPC Class Codes: G01F 23/2924 for several discrete levels, e.g. with more than one light-conducting sensing element G01F23/2927 takes precedence
• CPC Class Codes: G01F 23/2927 for several discrete levels, e.g. with more than one light-conducting sensing element
• CPC Class Codes: G01F 23/802 Particular electronic circuits for digital processing equipment
• CPC Class Codes: G01F 23/804 containing circuits handling parameters other than liquid level
• CPC Class Codes: G01F 23/808 containing circuits handling parameters other than liquid level

Abstract

A bedside apparatus and method designed to collect and monitor liquids output from a catheterized patient including an electronic unit and one of a plurality of defined disposable collecting and measuring rigid vessels that may differ in shape and size. Each defined vessel has at least one inlet to connect to a catheter outputting liquid from a patient in order to collect the liquid in the defined vessel. The defined vessel has at least one outlet valve to control draining of liquid from the vessel. An electronic unit has a configuration to receive the defined vessel and to securely mount and hold the defined vessel in a fixed relationship. The electronic unit further has a liquid level sensing device located in juxtaposition to the defined vessel to sense the level of liquid contained in the vessel.

Claims

1. Non-transitory computer readable media having recorded thereon program instructions for controlling a bedside apparatus to collect and measure body liquid issuing from a patient, the bedside apparatus composed of a holder for holding a collecting and measuring rigid vessel in a horizontal orientation, said holder defining a vertically oriented optical segment having opposite sides, a vertical array of spaced LEDs mounted in the holder on one said opposite side of said optical segment, a single vertically oriented photodetector device having an output mounted in said holder on the other opposite side of said optical segment to receive light from said vertical array of spaced LEDs, the light from each said LED overlapping adjacent vertically spaced LEDs, wherein the disposable collecting and measuring rigid vessel having an inlet and a configuration whereby a portion of the vessel fits in said optical segment for light to pass therethrough and wherein the inlet can be connected to a catheter outputting liquid from a patient in order to collect liquid in the vessel;

a disposable rigid collecting and measuring vessel of a preselected set of types having an inlet at its top connectable via an inlet valve to a catheter outputting liquid from a patient and an outlet at its bottom and defining a transparent optical part extending vertically from bottom to top of said measuring vessel that is geometrically configured such that light as it passes through the optical part of the measuring vessel has a predetermined refraction in dependence on whether there is liquid present in the light path, which predetermined refraction causes said light to by-pass the photodetector device;

said apparatus including an identifier capable of differentiating between different types of measuring vessels;

said program instructions including instructions operative (a) for serially and cyclically at defined intervals scanning the LEDs in succession to detect the intensity or luminance of light from each LED detected by the single vertically oriented photodetector device and to output signals correlated to the detected intensity or luminance for each LED, (b) for storing said output signals in memory, (c) for processing said output signals according to the predetermined algorithm to determine the height of collected liquid in the optical part of the measuring vessel, and (d) for storing information about the height of collected liquid in memory;

said program instructions including further instructions for operatively determining via a microprocessor and a preselected algorithm based on the output of the single vertically oriented photodetector device of the level of liquid in said optical segment (e) for calculating and outputting an indication of the volume of liquid in said measuring vessel;

(f) for actuating a valve controller for opening an outlet valve in response to a signal generated by a sensed condition of the liquid volume in the measuring vessel for draining liquid contained in said vessel; and

(q) for outputting the calculated value of liquid volume contained in said vessel at the time of the sensed condition and storing same in memory;

wherein the program instruction include still further instructions for carrying out multiple scans for each defined interval scanning with recording of results in a temporary memory;

analysis of temporary recorded results and correction by removal of artifacts;

averaging of corrected temporary recorded results; and

storing of the remaining averaged results for data processing to control draining of liquid from said vessel according to a sensed condition of one of (i) predetermined time intervals and (ii) predetermined fluid level thus enabling clinical staff to view the measuring vessel with respect to collected liquid characteristics including color, blood in the fluid and sedimentation.

2. Computer readable media according to claim 1 including further program instructions for displaying the calculated value of liquid contained in said vessel.

3. Computer readable media according to claim 1 wherein the sensed condition is one of volume and time.

4. Computer readable media according to claim 1 further including program instructions for monitoring pressure in the body cavity, and outputting a signal indicative of the monitored pressure.

5. Computer readable media according to claim 1 further including program instructions for controlling the inlet to the vessel responsive to the pressure in the body cavity.

6. A bedside apparatus to collect and monitor liquids output from a catheterized patient comprising:

a holder mountable in a horizontal orientation defining a vertically oriented optical segment cavity having opposite sides, a vertically array of spaced LEDs mounted along a height of said optical segment cavity on one side of said optical segment cavity with their optical axes in parallel substantially perpendicular to the height of said optical segment cavity with the LEDs equally space vertically and each directing its diverging light ray toward the other side of said optical segment cavity, said LEDs being configured so that every LED'"'"'s diverging light ray partially overlaps the light rays of its upper and lower neighboring LEDs as it traverses the optical segment cavity, and a single vertically oriented photodetector device mounted in said holder on the opposite side of said optical segment cavity, the photodetector device positioned to receive non-refracted light from each LED of said vertical array of spaced LEDs that passes through the optical segment cavity and to output signals correlated to detected intensity or luminance;

a disposable rigid collecting and measuring vessel of a preselected set of types having an inlet at its top connectable via an inlet valve to a catheter outputting liquid from a patient and an outlet at its bottom and defining a transparent optical part extending vertically from bottom to top of said measuring vessel that is geometrically configured such that light as it passes through the optical part of the measuring vessel has a predetermined refraction in dependence on whether there is liquid present in the light path, which predetermined refraction causes said light to by-pass the photodetector device;

said apparatus including an identifier capable of differentiating between different types of measuring vessels;

said measuring vessel being demountably held on said holder in a fixed position with its optical part positioned vertically in said vertically oriented optical segment cavity so that light from said vertically spaced LEDs is directed through the optical part of said measuring vessel as it traverses said optical segment cavity, with the single vertically oriented photodetector device receiving only unrefracted light;

said holder further includes (i) a memory and (ii) a microprocessor including a program operative (a) for serially and cyclically at defined intervals scanning the LEDs in succession to detect the intensity or luminance of light from each LED detected by the vertically oriented photodetector device and to output signals correlated to the detected intensity or luminance for each LED, (b) for storing said output signals in said memory, (c) for processing said output signals according to a predetermined algorithm to determine the height of collected liquid in the optical part of the measuring vessel, and (d) for storing information about the height of collected liquid in memory, wherein the program is further operative for carrying out multiple scans for each defined interval scanning with recording of results in a temporary memory;

analysis of temporary recorded results and correction by removal of artifacts;

averaging of corrected temporary recorded results; and

storing of the remaining averaged results for data processing to determine the corrected height of collected liquid in the optical part of the measuring vessel;

said apparatus further includes at least one electrical motor having an output drive shaft that operatively engages with an outlet valve mounted on said measuring vessel, wherein operation of the at least one electric motor opens or closes the outlet valve in response to predetermined conditions of operation of the microcontroller thereby controlling draining of liquid from said vessel according to one of (i) predetermined time intervals and (ii) predetermined fluid level thus enabling clinical staff to view collected liquid characteristics including color, blood in the fluid and sedimentation.

7. Bedside apparatus according to claim 6 wherein the holder further includes at least two fixation clamps to fixate, mount and hold said measuring vessel in said fixed relationship.

8. Bedside apparatus according to claim 6 further comprising a pressure monitoring device for monitoring pressure in a draining organ of a catheterized patient and for providing an output signal indicative of the monitored pressure communicated to the microcontroller, and said microcontroller configured for controlling said inlet valve responsive to the received output signal indicative of the monitored pressure.

9. Bedside apparatus according to claim 6 wherein the apparatus further includes a hanging device to hold the apparatus horizontally.

10. The bedside apparatus according to claim 6 further including a tilt sensor for sensing angle from the horizontal of the measuring vessel and for providing an output coupled to the microprocessor to correct for any tilt of the measuring vessel from horizontal.

11. The bedside apparatus according to claim 6 further including a disposable flexible collecting bag having an inlet that is mounted on the measuring vessel with the inlet of the collecting bag coupled to the outlet of the measuring vessel so that liquid content of the measuring vessel can be periodically emptied on the basis of one of time or volume.

12. A method of monitoring a bedside apparatus to collect liquids output from a catheterized patient comprising the steps of:

providing a holder mountable in a horizontal orientation defining a vertically oriented optical segment cavity having opposite sides, a vertically array of spaced LEDs mounted along a height of said optical segment cavity on one side of said optical segment cavity with their optical axes in parallel substantially perpendicular to the height of said optical segment cavity with the LEDs equally space vertically and each directing its diverging light ray toward the other side of said optical segment cavity, said LEDs being configured so that every LED'"'"'s diverging light ray partially overlaps the light rays of its upper and lower neighboring LEDs as it traverses the optical segment cavity, and a single vertically oriented photodetector device mounted in said holder on the opposite side of said optical segment cavity, the photodetector device positioned to receive non-refracted light from each LED of said vertical array of spaced LEDs that passes through the optical segment cavity and outputs signals correlated to detected intensity or luminance;

providing a disposable rigid collecting and measuring vessel of a preselected set of types having an inlet at its top connectable to a catheter outputting liquid from a patient and an outlet at its bottom and defining a transparent optical part extending vertically from bottom to top of said measuring vessel that is configured such that light as it passes through the optical part of the measuring vessel has a predetermined refraction in dependence on whether there is liquid present in the light path;

differentiating between different types of measuring vessels using an identifier;

mounting said measuring vessel on said holder in a fixed position with its optical part positioned in said vertically oriented optical segment cavity so that light from said vertically spaced LEDs is directed through the optical part of said measuring vessel as it traverses said optical segment cavity, with the single vertically oriented photodetector device receiving only light that has not been refracted due to liquid in the light path;

wherein said holder further includes (i) a memory including a program and (ii) a microprocessor responsive to said non-transitory program operative (a) for serially and cyclically at defined intervals scanning the LEDs in succession to detect the intensity or luminance of light from each LED detected by the single vertically oriented photodetector device and to output signals correlated to the detected intensity or luminance for each LED, (b) for storing said output signals in said memory, (c) for processing said output signals according to a predetermined algorithm to determine the height of collected liquid in the optical part of the measuring vessel, and (d) for storing information about the height of collected liquid in memory,

wherein the program is further operative for instructing the microprocessor for carrying out multiple scans for each defined interval scanning with recording of results in a temporary memory;

analysis of temporary recorded results and correction by removal of artifacts;

averaging of corrected temporary recorded results and storing of the remaining averaged results for data processing to determine the corrected height of collected liquid in the optical part of the measuring vessel;

providing further at least one electrical motor having an output drive shaft that operatively engages with an outlet valve mounted on said measuring vessel, wherein operation of the at least one electric motor opens or closes the outlet valve in response to predetermined conditions of operation of the microcontroller thereby controlling draining of liquid from said vessel according to one of (i) predetermined time intervals and (ii) predetermined fluid level thus enabling clinical staff to view collected liquid characteristics including color, blood in the fluid and sedimentation;

scanning the LEDs cyclically at successive defined intervals to detect the intensity or luminance of light of each LED by the single vertically oriented photodetector device and to output signals for each defined interval correlated to the detected intensity or luminance of each LED;

storing said output signals in memory;

carrying out multiple scans for each defined interval scanning with recording of results in a temporary memory;

processing said output signals for each defined interval according to a predetermined algorithm that a. analyzes temporary recorded results and correcting by removal of artifacts;

b. averages corrected temporary recorded results;

c. stores the remaining averaged results; and

d. then data processes the averaged results to determine the corrected height of collected liquid in the optical part of the measuring vessel at each defined interval; and

storing in memory information related to volume of liquid contained in the measuring vessel based on the determined height of collected liquid for each defined interval.

13. Method according to claim 12 further including the step of controlling said inlet.

14. Method according to claim 12 including the further step of optically identifying the type of disposable measuring vessel.

15. Method according to claim 12 including the further step of the operatively controlling an electrical motor having an output drive shaft that operatively engages with a valve in the inlet, and micro-controlling operatively a level sensing device and the electric motor to open or close the valve in response to predetermined conditions.

16. Method according to claim 12 including the further steps of operatively controlling an output valve to control draining of liquid from said vessel according to one of predetermined time intervals and predetermined fluid level of liquid collected in said measuring vessel thus enabling clinical staff to view collected liquid characteristics including color, blood in the fluid and sedimentation.

17. Method according to claim 12 comprising the further step of monitoring pressure in a draining organ of a catheterized patient;

providing an output signal indicative of the monitored pressure; and

controlling the disposable collecting vessel responsive to the output signal indicative of the monitored pressure.

18. Method according to claim 12 including the further steps of inducing pressure by administrating fluid into the draining organ, and adjusting the volume of liquid output by subtracting the additional fluid administrated to induce pressure.

19. Method according to claim 12 including the step of opening the outlet of the measuring vessel in response to receiving a signal indicative of a predetermined volume in said measuring vessel.

20. Method according to claim 12 including the step of opening the outlet of the measuring vessel in response to receiving a signal indicative of a predetermined time.

21. Method according to claim 12 including the further step of hanging the defined vessel horizontally from a bed in which a patient is lying and from whom fluid is being drained.

22. Method according to claim 12 including the further steps of monitoring the vessel for a tilt, outputting a tilt signal responsive to the tilt condition of the vessel, and determining responsive to the tilt output signal the relative horizontal orientation of the vessel.

23. Method according to claim 12 including the further steps of monitoring the measuring vessel for overflowing fluid that rises above a predetermined threshold, and responsive thereto draining the overflowing fluid through a bypass channel provided in an outlet valve.

24. The method according to claim 12 including the further step of one of (i) displaying visually the determined volume of liquid updated for each defined interval, and (ii) transmitting data periodically via a communication port.