SYSTEMS AND METHODS FOR AUTOMATED ASSESSMENT AND MONITORING OF BODILY FLUIDS

Abstract

Systems and methods for automated assessment and monitoring of bodily fluids are disclosed. In one embodiment, a system for provisioning a treatment composition to a bladder of a patient includes: an irrigation bag that carries the treatment composition; a catheter configured for connecting the irrigation bag to the bladder; a flow regulator configured for controlling a flow of the treatment composition from the irrigation bag to the bladder; and a drainage bag in fluid communication with the bladder through a drainage tubing of the catheter. The drainage tubing is configured for draining urine from the bladder. The system also includes: a first sensor for detecting a first amount of the treatment composition in the irrigation bag; a second sensor for detecting a second amount of urine in the drainage bag; a third sensor for detecting a concentration of particles in the urine carried by the drainage bag; and a controller.

Claims

1. A system for provisioning a treatment composition to a bladder of a patient, the system comprising: an irrigation bag that carries the treatment composition; a catheter configured for connecting the irrigation bag to the bladder; a flow regulator configured for controlling a flow of the treatment composition from the irrigation bag to the bladder; a drainage bag in fluid communication with the bladder through a drainage tubing of the catheter, wherein the drainage tubing is configured for draining urine from the bladder; a first sensor for detecting a first amount of treatment composition in the irrigation bag; a second sensor for detecting a second amount of urine in the drainage bag; a third sensor for detecting a concentration of particles in urine carried by the drainage bag; and a controller configured for: receiving data representative of the first amount of treatment composition in the irrigation bag and the second amount of urine in the drainage bag, receiving data representative of the concentration of particles in the urine carried by the drainage bag, and based on received data, controlling the flow regulator.

2. The system of claim 1, wherein the particles in the urine are blood particles and wherein the treatment composition is configured to dilute hematuria or clot in the bladder.

3. (canceled)

4. The system of claim 1, wherein the first sensor and the second sensor are each a weight sensor, a level sensor or a volume sensor, and wherein the third sensor is a color sensor, a wavelength sensor or an ultrasound sensor.

5-6. (canceled)

7. The system of claim 1, further comprising a hematuria measurement system configured to at least partially carry the third sensor and the drainage tubing of the catheter, wherein the hematuria measurement system holds the drainage tubing in a bent position configured to form a pool of urine within a bend of the drainage tubing.

8. The system of claim 7, wherein the bend of the drainage tubing is U-shaped or W-shaped.

9. The system of claim 7, wherein the third sensor is a color sensor configured to differentiate among shades of the pool of urine within the bend of the drainage tubing.

10. The system of claim 1, wherein the flow regulator comprises: a motorized valve; and a motor configured to operate the motorized valve, wherein the motor is in a data communication with the controller.

11-13. (canceled)

14. A method for delivering a treatment composition to a bladder of a patient, the method comprising: detecting a first amount of treatment composition in an irrigation bag by a first sensor; flowing the treatment composition from the irrigation bag to the bladder through a catheter; controlling a flow of treatment composition by a flow regulator; detecting a second amount of urine in a drainage bag by a second sensor; comparing, by a controller, the first amount of treatment composition in the irrigation bag and the second amount of urine in the drainage bag; determining, by the controller, whether the flow of treatment composition from the irrigation bag is balanced by a flow of urine from the bladder; and sending, by the controller, a control signal to the flow regulator.

15. (canceled)

16. The method of claim 14, further comprising: detecting, by a hematuria measurement system, a concentration of blood in urine carried by the drainage bag; based on detecting by the hematuria measurement system, sending the control signal to the flow regulator by the controller; and setting an alert signal when the concentration of blood in urine carried by the drainage bag exceeds a predetermined threshold.

17. (canceled)

18. The method of claim 16, wherein the hematuria measurement system at least partially holds the catheter in a bent position that enables forming a pool of urine within a bend of the catheter.

19. The method of claim 18, wherein the bend of the drainage tubing is U-shaped or W-shaped.

20. The method of claim 18, wherein the hematuria measurement system comprises a color sensor configured to differentiate among shades of the pool of urine within the bend of the catheter.

21. The method of claim 14, wherein the flow regulator comprises: a motorized valve; and a motor configured to operate the motorized valve, wherein the motor is in a data communication with the controller.

22. The method of claim 14, wherein the treatment composition is configured to dilute hematuria or clot in the bladder.

23. A device for determining a particle concentration in a bodily fluid, the device comprising: a housing; a drainage tubing attached to the housing, wherein the drainage tubing includes at least one bend configured for holding the bodily fluid; and a color sensor configured for detecting the particle concentration in the bodily fluid held in the at least one bend of the drainage tubing.

24. The device of claim 23, further comprising a color sensor control circuit configured to: control the color sensor; and receive data from the color sensor.

25. The device of claim 24, wherein the housing is a clam-shell housing, and wherein the tube holder at least partially surrounds the drainage tubing and the color sensor when the housing is closed, the device further comprising: a tube holder configured to, in operation, at least partially surround the drainage tubing and the color sensor; and a source of light configured to illuminate the at least one bend of the drainage tubing, wherein the source of light is configured inside the tube holder when the housing is closed.

26-28. (canceled)

29. The device of claim 23, further comprising: a weight sensor configured to detect a weight of a drainage bag that is in fluid communication with the drainage tubing; and a weight sensor control circuit configured to receive data from the weight sensor.

30. The device of claim 29, wherein the drainage bag weight sensor and the weight sensor control circuit are configured inside the housing.

31. The device of claim 23, wherein the bodily fluid comprises urine and wherein particles in the bodily fluid comprise blood particles.

32-38. (canceled)

Description

DESCRIPTION OF THE DRAWINGS

[0030] The foregoing aspects and many of the attendant advantages of the inventive technology will become more readily appreciated as the same are understood with reference to the following detailed description, when taken in conjunction with the accompanying drawings, wherein:

[0031] FIG. 1 is a partially schematic view of a continuous bladder irrigation system in accordance with prior art;

[0032] FIG. 2 is an isometric view of a triple-lumen catheter in accordance with prior art;

[0033] FIG. 3 is a partially schematic view of a continuous bladder irrigation system in accordance with an embodiment of the present technology;

[0034] FIG. 4 is a plan view of a hematuria measurement system in accordance with an embodiment of the present technology;

[0035] FIG. 5A is a partially schematic view of hematuria specimens in accordance with embodiments of the present technology;

[0036] FIG. 5B is a schematic view of a urine retention mechanism in accordance with an embodiment of the present technology;

[0037] FIG. 6 is an isometric view of a flow regulator in accordance with embodiments of the present technology;

[0038] FIG. 7 is a flowchart of a control process in accordance with an embodiment of the present technology;

[0039] FIG. 8 is a graph of drip rate, drainage bag weight and irrigation bag obtained in accordance with an embodiment of the present technology; and

[0040] FIG. 9 is a graph of hematuria level obtained in accordance with an embodiment of the present technology.

DETAILED DESCRIPTION

[0041] While several embodiments have been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the claimed subject matter.

[0042] FIG. 3 is a partially schematic view of a continuous bladder irrigation system 1000 in accordance with an embodiment of the present technology. In some embodiments, the irrigation bag 10 may be carried by a weight sensor 110. The illustrated irrigation bag 10 includes saline 11, but in different embodiments the irrigation bag may include other liquids, for example, water mixed with other components like sugar (e.g., Dextrose or Glucose), water mixed with antibiotics, painkillers or other medications. Furthermore, a combination of urine and blood is referred to when describing the inventive technology, however, different combinations of bodily fluids and inorganic or organic particles are also encompassed by the embodiments of the present technology.

[0043] In operation, saline 11 drains through the catheter 30 into the bladder 25. The hematuria and/or blood clots inside the bladder are diluted and flown into a drainage bag 400 as a mixture of urine and blood 45.

[0044] In some embodiments, a weight sensor 120 supports the drainage bag 400. In some embodiments, a controller 350 receives data from the weight sensors 110 and 120. Based on the received data, the controller 350 detects whether weight reduction of the irrigation bag 10 corresponds (or at least approximately corresponds) to weight increase of the drainage bag 400. If, for example, the weight reduction of the irrigation bag 10 exceeds weight increase of the drainage bag 400, an excessive accumulation of the saline 11 in the patient's bladder 25 may occur. In response, the controller 350 may issue a control command to a flow regulator 200 (e.g., a valve or a clamp) to reduce or stop the flow of saline 11 into the bladder 25. Conversely, when the weight reduction of the irrigation bag 10 is smaller than the weight increase of the drainage bag 400, the system may not be providing enough saline to the bladder, and the controller 350 may issue control command to the flow regulator 200 to increase the flow of saline 11. In different embodiments, the control of the flow of saline 11 may be based upon, for example, a flow meter (not shown) configured to measure the flow of saline.

[0045] In some embodiments, a sensor 314 (e.g., a color sensor, a wavelength sensor, an ultrasound sensor) may detect color of urine 45 as it flows through a transparent or semitransparent catheter 30 toward the drainage bag 400. Based on the signal received from the color sensor 314, the controller 350 may regulate the flow of saline through the flow regulator 200 or set an alert signal 105 to, for example, alert the nurse about unusual or dangerous conditions. Some embodiments of the color sensor 314 and the accompanying electrical and mechanical hardware are described with respect to FIG. 4 below.

[0046] FIG. 4 is a plan view of a hematuria measurement system 300 in accordance with an embodiment of the present technology. The illustrated embodiment includes a housing 305 having tube holders 307 that keep the drainage tubing 320 in a shape configured to retain a urine pool 315 inside the bend of the tubing. In some embodiments, the housing 305 may be configured as clamshell housing. When the housing 305 is closed, the tube holders 307 secure the drainage tubing 320 in its prescribed shape.

[0047] In some embodiments, the color sensor 314 is held proximately to the urine pool 315 in a relatively fixed position that facilitates repeatable measurements of the particle concentration in the urine pool. The color sensor 314 may be controlled by a controller 312. In some embodiments, a source of light 316 may illuminate the drainage tubing 320 to facilitate operation of the color sensor 314. In operation, closing of the housing 305 prevents or at least minimizes irradiance of stray light on the color sensor 314.

[0048] In some embodiments, the hematuria measurement system 300 includes the weight sensor 120 that can measure the weight of urine in the drainage bag 400. A controller 310 may control the weight sensor 120. In some embodiments, a power source 325 provides power to the sensors (e.g., light sensor and/or weight sensor) and the controllers 310 and 312 of the hematuria measurement system 300.

[0049] FIG. 5A is a partially schematic view of hematuria specimens in accordance with embodiments of the present technology. The illustrated specimens 315-A to 315-E represent urine (or other bodily fluid) with differing concentrations of blood (or other particles). In operation, a color sensor (not shown) can distinguish between the illustrated concentrations. In many applications, it may be enough for the color sensor to distinguish among several (e.g., 5 or so) differing shades of urine without having to determine the exact numerical concentration of the particles in the bodily fluid. For the controller to, for example, regulate the opening of the control valve, set an alarm signal, or set other actuators or alarms, it may be enough to recognize that the concentration of the particles in the bodily fluid is below or above the level shown by, for example, the specimen 315-C.

[0050] FIG. 5B is a schematic view of a urine retention mechanism in accordance with an embodiment of the present technology. The drainage tubing 320 is shown in three representative shapes. The upper configuration of the drainage tubing 320 is a U-shaped tube. In other embodiments, the drainage tubing 320 may have a W-shaped bend, providing two spaces for retaining the bodily fluid.

[0051] The middle configuration of the drainage tubing 320 in FIG. 5B illustrates a condition for maintaining a pool of bodily fluid with particles. Here, level B is above level A, thus providing for a pool of bodily fluid that extends up to the level B.

[0052] The lower configuration of the drainage tubing 320 illustrates a limiting condition for maintaining a pool of bodily fluid. Under this limiting condition, level A corresponds to level B. In some embodiments, this limiting condition determines a minimum relative height of the level B with respect to the level A that still retains a pool of bodily fluid.

[0053] FIG. 6 is an isometric view of a flow regulator 200 in accordance with embodiments of the present technology. In some embodiments, the flow regulator 200 includes a pinch valve 210 the pinches the drainage tubing 322 to reduce the flow of urine through the tubing. In other embodiments, the valve 210 may be based on a lever arm, a roller clamp, a T-handle, or other mechanisms. In some embodiments, the valve 210 may be driven by a motor 215 that is secured by a mounting flange 220, but other securements of the motor 215 are also possible. In operation, the motor 215 may be controlled by the controller 350, as explained in more detail with respect to FIG. 3 above.

[0054] FIG. 7 is a flowchart of a control process in accordance with an embodiment of the present technology. In some embodiments, the control process includes collecting data from the weight sensors 110, 120 and/or color sensor 310 by the microprocessor 350. Based on this input, the microprocessor 350 may issue visual or audio alerts 400, and may control the flow regulator 200 (e.g., a valve). The microprocessor 350 may include a combination of hardware and software to execute the above tasks. A loop 500 illustrates such senseprocessact control loop.

[0055] FIG. 8 is a graph of drip rate, drainage bag weight and irrigation bag weight obtained in accordance with an embodiment of the present technology. The vertical axis represents normalized units (e.g., flow rate or normalized weight). The horizontal axis represents time in minutes. Dash line denotes weight of the drainage bag and dash-dot line denotes weight of the irrigation bag. Solid line represents a flow rate of the fluid (e.g., saline) out of the irrigation bag. The illustrated results were obtained by the embodiments of the present technology.

[0056] Over the time of about 30 minutes, the irrigation bag loses weight, because it provides saline to the bladder of the patient, while the drainage bag gains weight, because it receives urine from the bladder of the patient. A relatively slow decrease of the weight of the irrigation bag (marked by a relatively gradual slope of the dash-dot line) corresponds to the similarly slow increase of the weight of the drainage bag, whereas a relatively fast decrease of the weight of the irrigation bag (marked by a relatively steep slope of the dash-dot line) corresponds to the similarly fast increase of the weight of the drainage bag. Correspondingly, the periods of relatively high drip rate (solid line) correspond to the periods of the relatively fast decrease of the weight of the irrigation bag, whereas the periods of relatively slow drip rate correspond to the periods of the relatively slow decrease of the weight of the irrigation bag. The above correspondence generally indicates absence of the clot-induced blockage of the urine outflow of the patient. In some embodiments, the scenario shown in FIG. 8 would not trigger an alarm, but would instead be considered an acceptable operational scenario.

[0057] FIG. 9 is a graph of hematuria level obtained in accordance with an embodiment of the present technology. The vertical axis represents normalized units (e.g., flow rate or hematuria level). The horizontal axis represents time in minutes. Solid line represents a hematuria level in the urine that flows out of the patient's bladder through, for example, drainage tubing 320 inside the device 300. Short dash line represents flow rate of the fluid (e.g., saline) out of the irrigation bag. Long dash line represents the color levels corresponding to, for example, samples 315-A to 315-E shown in FIG. 5A. The illustrated results were obtained by the embodiments of the present technology.

[0058] In operation, periods of relatively low drip rates of fluid from the irrigation bag (e.g., a relative flatlining of the drip rates in the range of about 0.1 to about 0.3) are typically followed by an increase in the concentration of blood in the urine, as seen by the hematuria levels trending toward sample A and sample B in the graph. In response, the system increases the drip rates of the fluid from the irrigation bag (see, e.g., relatively high values of the drip rates in the range of about 0.8 to about 1), which in turn dilute the hematuria in blood, therefore driving hematuria level back toward the target zone (e.g., between sample C and sample D). Therefore, over most of the operational time the system autonomously maintains hematuria level between the sample C and sample D levels, which is a safe zone level.

[0059] Many embodiments of the technology described above may take the form of computer- or controller-executable instructions, including routines executed by a programmable computer or controller. Those skilled in the relevant art will appreciate that the technology can be practiced on computer/controller systems other than those shown and described above. The technology can be embodied in a special-purpose computer, controller or data processor that is specifically programmed, configured or constructed to perform one or more of the computer-executable instructions described above. Accordingly, the terms computer and controller as generally used herein refer to any data processor and can include Internet appliances and hand-held devices (including palm-top computers, wearable computers, cellular or mobile phones, multi-processor systems, processor-based or programmable consumer electronics, network computers, mini computers and the like).

[0060] The present application may also reference quantities and numbers. Unless specifically stated, such quantities and numbers are not to be considered restrictive, but exemplary of the possible quantities or numbers associated with the present application. Also in this regard, the present application may use the term plurality to reference a quantity or number. In this regard, the term plurality is meant to be any number that is more than one, for example, two, three, four, five, etc. The terms about, approximately, etc., mean plus or minus 5% of the stated value.

[0061] From the foregoing, it will be appreciated that specific embodiments of the technology have been described herein for purposes of illustration, but that various modifications may be made without deviating from the disclosure. Moreover, while various advantages and features associated with certain embodiments have been described above in the context of those embodiments, other embodiments may also exhibit such advantages and/or features, and not all embodiments need necessarily exhibit such advantages and/or features to fall within the scope of the technology. Accordingly, the disclosure can encompass other embodiments not expressly shown or described herein.