Patent Publication Number: US-2019192760-A1

Title: System and device for intelligent bladder irrigation and method for using the like

Description:
TECHNICAL FIELD 
     The present disclosure relates generally to bladder irrigation of patients in a hospital or other healthcare setting, more particularly to controlling irrigation rates during continuous bladder irrigation. 
     BACKGROUND 
     In the urological field, blood clot formation in the bladder is of particular concern as the clots may cause blockages that can lead to bladder rupture or other negative outcomes, including death. As such, many conditions and procedures implicating a patient&#39;s bladder require irrigation in order to flush or wash the bladder during treatment or recovery. Specifically, continuous bladder irrigation (CBI) may be used to prevent clot formation in the bladder. CBI may also serve to enhance hemostasis and prevent occlusion of the indwelling catheter. Transurethral resection of the prostate (TURP) is one common type of urological procedure that typically requires continuous bladder irrigation treatment. For example, bladder tumors (of which, approximately 60,000 cases are diagnosed each year) almost always require TURP. Approximately another 90,000 additional procedures are performed each year (together, totaling approximately 150,000 procedures annually) to treat various other conditions as well. Even further, conditions that may cause intractable bleeding of the bladder, such as hemorrhagic cystitis, often necessitates CBI independent of surgical manipulation. 
     While medical technology has advanced rapidly in many areas, continuous bladder irrigation is still typically performed manually. Manual administration of this procedure requires healthcare providers to continuously monitor the patient&#39;s progress by inspecting the irrigation effluent at regular intervals, typically ranging from several minutes to several hours. Typically, the rate at which the irrigating fluid is delivered to the patient must be constantly adjusted in response to these observations. One known strategy involves turning a roller clap that regulates the flow of irrigation fluid (i.e., a Murphy drip). 
     Current procedures have several limitations and provide challenges for healthcare providers as the inflow rate can only be adjusted when the provider is in the room. These limitations can result in either excessive use of irrigating solution, which may require frequent changing of irrigation bags, or insufficient use, which may cause clot formation and possibly require surgical intervention. Further, current procedures are fairly inefficient as they tend to require continuous monitoring, cause inventory to be wasted, and compromise the health of both patients and healthcare providers. 
     One attempt to automate CBI is disclosed in PCT Publication No. WO 2017/112728 to Arun Rai et al. (“Rai”). Rai discloses an autonomous CBI strategy that includes a pressure sensor unit apparently configured to monitor changes in intra-abdominal pressure that may be indicative of a bladder occlusion in some instances. While this and other strategies for autonomous CBI may potentially be effective in detecting a bladder occlusion under optimal conditions, one of skill in the art will appreciate that pressure measurements by the pressure sensor unit described in Rai may be affected by external factors, such as a change in the patient&#39;s body position. As such, strategies for reliable, accurate autonomous CBI administration remain desirable. 
     SUMMARY 
     In one aspect, a bladder irrigation system includes a catheter having an elongate tubular body positionable within a bladder of a patient, and having formed therein an inflow lumen for supplying an irrigant to the patient&#39;s bladder, and an outflow lumen for draining an effluent from the patient&#39;s bladder. The system also includes a sensor structured to sense a property of the effluent drained from the patient&#39;s bladder indicative of an irrigation status, a flow discrepancy mechanism structured to monitor a parameter indicative of a flow discrepancy between a flow of the irrigant to the patient&#39;s bladder and a flow of the effluent from the patient&#39;s bladder, a flow varying mechanism structured to vary a flow of the irrigant to the patient&#39;s bladder, and a control device structured to output a flow varying control signal responsive to at least one of the irrigation status or the parameter indicative of a flow discrepancy to vary a flow control state of the flow varying mechanism. 
     In another aspect, a device for controlling bladder irrigation in a patient includes a flow varying mechanism structured to vary a flow of an irrigant supplied to the patient&#39;s bladder, and a control device coupled with the flow varying mechanism, the control device being structured to determine an irrigation status from a parameter sensed by a sensor, detect an adverse bladder condition from a flow discrepancy observed by a flow discrepancy mechanism, and output a flow varying control signal responsive to at least one of the irrigation status or the adverse bladder condition to adjust a flow control state of the flow control mechanism. 
     In still another aspect, a method for bladder irrigation includes monitoring a first parameter indicative of at least one of a flow of an irrigant supplied to a patient&#39;s bladder or a flow of an effluent drained from the patient&#39;s bladder, monitoring a second parameter indicative of a property of the drained effluent, outputting a flow varying control signal responsive to at least one of the first parameter or the second parameter, and adjusting the flow of the irrigant supplied to the patient&#39;s bladder responsive to the flow varying control signal. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a diagrammatic view of a system for bladder irrigation, according to one embodiment; 
         FIG. 2  is a sectioned diagrammatic view of a catheter, according to one embodiment; and 
         FIG. 3  is a diagrammatic view of a control mechanism, according to one embodiment; 
         FIG. 4  is a diagrammatic view of a control mechanism, according to one embodiment; 
         FIG. 5  is a diagrammatic view of a control mechanism, according to one embodiment; 
         FIG. 6  is a flowchart illustrating example process and control logic, according to one embodiment; 
         FIG. 7  is a flowchart illustrating example process and control logic, according to one embodiment; and 
         FIG. 8  is a flowchart illustrating example process and control logic, according to one embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Referring to  FIG. 1 , an exemplary intelligent bladder irrigation system (“system”)  10  configured to facilitate a continuous bladder irrigation procedure (hereinafter, “procedure”) is shown according to one embodiment. It is contemplated that applications in which continuous bladder irrigation procedures are employed in the medical or hospital setting will particularly benefit from the teachings set forth herein; however, the present disclosure is not strictly limited to any particular setting or application. System  10  may include a fluid conduit  12  structured to supply a liquid irrigant solution (hereinafter, “irrigant”)  14  to a patient&#39;s bladder  16 , and to drain a liquid effluent mixture (hereinafter, “effluent”)  18  therefrom. 
     Fluid conduit  12  may include an irrigant source  20  that contains an amount of irrigant  14 , a catheter  22  having an elongate tubular body positionable within bladder  16 , and an effluent container  24  for collecting effluent  18  drained from bladder  16 . Irrigant source  20  is typically a gravity-fed intravenous (IV) drip bag preferably having a fluid capacity that ranges from about 3000 mL to about 5000 mL, but might be any other type of suitable irrigant container having a different fluid capacity. Irrigant  14  may include solutions consisting of sodium chloride 0.9%, aluminum ammonium sulphate, aluminum potassium sulphate, E -aminocaproic acid, or any other suitable irrigation solution. Fluid conduit  12  may further include one or more tubing lines, such as an inflow line  26  and an outflow line  28 , that fluidly couple the individual components of fluid conduit  12 . For example, inflow line  26  may fluidly couple irrigant source  20  with catheter  22  for supplying irrigant  14  to bladder  16 , and outflow line  28  may fluidly couple catheter  22  with effluent container  24  for draining effluent  18  from bladder  16 . The tubing lines each have formed therein, a lumen structured to allow liquids  14 ,  18  to flow therethrough, and may be formed of one or more clear and/or light -permeable materials suitable for use in the medical context, such as polyvinyl chloride (PVC), polyurethane, or another polymeric material. As seen in  FIG. 1 , irrigant source  20  may include a series of containers of irrigant  14 , with each container being fluidly coupled to inflow line  26  by an adapter  30 . In some embodiments, irrigant source  20  may include any other number of containers of irrigant  14 , and/or may include an IV piggyback (IVPB) bag or other container to supply medicine, a different type of irrigant, or the like to bladder  16 . 
     System  10  is configured such that irrigant  14  is supplied to bladder  16  from catheter  22  at a particular rate (hereinafter, “inflow rate”) that may be inputted, calculated, adjusted, or otherwise determined in a manner consistent with the discussion herein. System  10  may be gravity-assisted such that the relative position of each of the components of fluid conduit  12  may at least partially determine the inflow rate such that the maximum inflow rate may be achieved by allowing irrigant  14  to flow freely through inflow line  26  to catheter  22 . In a normally proceeding procedure, the inflow rate may be expected to correspond with a rate at which effluent  18  is drained from bladder  16  through catheter  22  (hereinafter, “outflow rate”). In other embodiments, the flow of irrigant  14  into bladder  16  may be additionally and/or alternatively facilitated by a pump such as a peristaltic pump, a roller pump, or any other type of pump or other device suitable for use in a medical setting. It will be appreciated that the inflow rate and the outflow rate may be indicative of a flow or an amount of irrigant  14  supplied to bladder  16 , and indicative of a flow or an amount of effluent  18  drained from bladder  16 , respectively. As such, as used herein, “inflow rate” should be understood to include any measurement indicative of the amount of irrigant  14  supplied to bladder  16 , such as a volume, mass, or weight, and “outflow rate” should be understood to include any measurement indicative of the amount of effluent  18  drained from bladder  16 , such as a volume, mass, or weight. 
     Referring now also to  FIG. 2 , a cross section view of catheter  22  is shown. Catheter  22  may be a 3-way Y-shaped transurethral Foley catheter positionable within bladder  16 , and may be formed of a flexible, fluid impermeable material suitable for use in the medical context, such as silicone, latex, PVC, polyurethane, or another polymeric material. Some embodiments of catheter  22  may also include a coating such as a silicon elastomer, hydrogel, or polytetrafluoroethylene (PTFE). In other embodiments, catheter  22  may be a 2-way Y-shaped catheter, a 4-way Y-shaped catheter, or any other type of catheter. Catheter  22  may have a distal end  31  that terminates in bladder  16  and a proximal end  33  structured for coupling catheter  22  with inflow line  26  and outflow line  28 . Catheter  22  has formed therein, an inflow lumen  32  structured to receive irrigant  14  from inflow line  26 , and an outflow lumen  34  structured to drain effluent  18  from bladder  16 , each lumen  32 ,  34  extending between distal and proximal ends  31 ,  33 . Inflow lumen  32  and outflow lumen  34  may terminate at an inflow opening  36  and an outflow opening  40 , respectively, each opening  36 ,  40  being positioned at distal end  31 . Inflow opening  36  fluidly couples inflow lumen  32  with bladder  16  so as to allow irrigant  14  to be discharged from catheter  22  into bladder  16 , where irrigant  14  may mix with one or more bodily fluids  38 , which includes urine (hereinafter, “urine  38 ”), to form effluent  18 . Effluent  18  may evacuate bladder  16  through outflow opening  40 , which fluidly couples bladder  16  to outflow lumen  34  so as to allow effluent  18  to be drained from bladder  16  to outflow line  28 . Outflow line  28  may then carry effluent  18  to effluent container  24  for collection, monitoring, and/or disposal. 
     System  10  further includes one or more components that may be capable of acting in concert to sense or determine system parameters that are indicative of the progress or state of bladder irrigation (hereinafter, “irrigation status”), or system parameters that may be indicative of an adverse bladder condition, such as the presence of a bladder clot or other occlusion, a bladder rupture, or any other negative, unexpected, or otherwise undesirable outcome or condition implicated by the procedure, and adjusting the inflow rate in response. Components may include a flow discrepancy mechanism that has an inflow sensor  42  (illustrated in  FIGS. 3-5 , discussed hereinafter) coupled with inflow line  26  and an outflow sensor  44  coupled with outflow line  28 , an irrigation sensor  46  coupled with outflow line  28 , a control device  48  (illustrated in  FIGS. 3-5 , discussed hereinafter), and a flow varying mechanism  50  (illustrated in  FIGS. 3-5 , discussed hereinafter) coupled with inflow line  26 . 
     In other embodiments, system  10  may include additional and/or alternative components for sensing one or more system parameters that may be indicative of an adverse bladder condition, such as a sensor structured to measure, detect, or monitor a system parameter indicative of system pressure, bladder pressure, effluent mass or volume, or fluid temperature, or for commanding, controlling, or otherwise varying delivery or conveyance of irrigant  14  to bladder  16 , or draining effluent  18  from bladder  16 . As seen in  FIG. 1 , system  10  may include an irrigation control module (ICM)  52  structured, at least in part, to package one or more system components together in a common housing, to allow for manual control of a procedure, or to display or input a system parameter such as, for example, sensor sensitivity, type of irrigant used, irrigant source capacity, effluent container volume, procedure duration, a target value such as a target effluent color or a target volume of irrigant to be supplied, or a predetermined threshold value such as maximum inflow rate or a maximum flow discrepancy. ICM  52  may include a display screen  54 , a control panel  56  having one or more buttons  58  for inputting and/or controlling system parameters, and an alarm for outputting a warning notification or triggering other actions. The alarm may include lights  60  and speakers  62 , and may be structured to warn a medical professional if, for instance, a predetermined threshold value may have been or is expected to be met, for example exceeded, or an occlusion or rupture may have or is expected to form in bladder  16 . In other embodiments, the alarm may be structured to produce a different type of warning notification, such as a wireless signal, or any other form of visual, tactile, audio, or other type of notification. Display screen  54  may be a light-emitting diode (LED) display for displaying a user interface or for viewing system parameters or procedure information that may be of interest, such as, for example, an amount of irrigant  14  delivered to bladder  16 , an amount of irrigant  14  remaining in irrigant source  20 , an inflow rate, an amount of effluent  18  and/or urine  38  drained from bladder  16 , or an outflow rate. In some embodiments, display screen  54  may be, for instance, a touch screen structured to allow a user to input one or more system parameters, or may be any other type of display screen suitable for use in the medical context. In still other embodiments, ICM  52  may include a printer for printing a physical copy of the system parameters and/or procedure information. Buttons  58  may be configured to allow a medical professional to input a system parameter, manually adjust the inflow rate, terminate the procedure, or input or adjust any other parameter or setting. In some embodiments, ICM  52  may include different and/or additional components for controlling or configuring the procedure, or may include additional ports, switches, or jacks. 
     Referring now also to  FIGS. 3-5 , diagrammatic views of an interior of ICM  52  are shown. ICM  52  may include control device  48 , with each of inflow sensor  42 , outflow sensor  44 , and irrigation sensor  46  being coupled thereto in a manner that may allow each to send a signal encoding data indicative of a parameter of interest to control device  48 , or be interrogated by control device  48  to produce the subject data. For instance, sensors  42 ,  44 ,  46  may be coupled with control device  48  by either a wired or a wireless connection. The flow discrepancy mechanism may be structured to monitor and compare the inflow rate and the outflow rate. Inflow sensor  42  may be configured to measure, detect, or monitor the inflow rate, which may be indicative of an amount of irrigant  14  supplied to bladder  16 . For example, inflow sensor  42  may be a thermal mass-flow sensor having a heating element to heat a liquid and at least two temperature sensors to measure the temperature of the heated liquid downstream of the heating element, and may be structured to calculate a flow rate from the temperatures measured by the temperature sensors. In some embodiments, inflow sensor  42  may be structured to sense a different quantitative property indicative of the amount of irrigant  14  supplied to bladder  16 , such as a mass or volume of supplied irrigant  14 . Outflow sensor  44  may also be a thermal flow sensor and may be structured to measure, detect, or monitor the outflow rate, which may be indicative of an amount of effluent  18  drained from bladder  16 . In some embodiments, outflow sensor  44  may be structured to sense a different quantitative property indicative of the amount of effluent  18  drained from bladder  16 , such as a mass or volume of drained effluent  18 . Outflow sensor  44  may be structured to measure, and/or control device  48  may be structured to calculate and/or factor in, a rate at which the patient is producing urine  38 , or an amount of urine  38  the patient has produced during the procedure. In some embodiments, one or both of sensors  42 ,  44  may be a different type of flow meter, such as a variable area flow meter, a spring and piston flow meter, a mass gas flow meter, an ultrasonic flow meter, an optical flow meter, a pressure-based flow meter, a turbine flow meter, or may be any other type of suitable sensor. In other embodiments, one or both of sensors  42 ,  44  may be structured and/or positioned differently to measure, detect, or otherwise monitor a different quantitative property of irrigant  14  and effluent  18 , respectively, such as temperature or weight. It will be appreciated, however, that some embodiments of the flow discrepancy mechanism may just monitor and compare the inflow and the outflow rates without ever calculating or otherwise considering the amounts or other quantities of irrigant  14  and/or effluent  18 . 
     Irrigation sensor  46  may be positioned on or coupled with outflow line  28  and structured to sense a property of effluent  18  that may be indicative of the irrigation status of the procedure, wherein the irrigation status may indicate whether the inflow rate is sufficiently titrated to prevent an adverse bladder condition. In some embodiments, the property of effluent  18  sensed by irrigation sensor  46  may also be used by control device  48  to detect an adverse bladder condition. The sensed property of effluent  18  may include an optical property such as opacity or a color property. Irrigation sensor  46  may be a light-to -voltage converter, light-to-frequency converter, ambient light sensor, linear sensor array, color sensor, reflective light sensor, or any other type of sensor capable of identifying, detecting, or otherwise monitoring the property of interest. In an exemplary embodiment, irrigation sensor  46  includes a chromatic sensor structured to sense a concentration or an intensity of a reddish color indicative of an amount of blood in effluent  18 . The sensitivity of sensors  42 ,  44 ,  46  may be configurable such that sensitivity can be tuned to the relevant system parameters. For example, irrigation sensor  46  may have a variety of sensitivity levels, with each suitable to detect or measure different colors, color intensities, color concentrations, or the like. In some embodiments, irrigation sensor  46  may be structured to sense a different color property, such as the presence of a predetermined color, the shade of a predetermined color, or the rate at which one or more colors permeate effluent  18 . In other embodiments, irrigation sensor  46  may be structured to sense a different property of effluent  18 . In still other embodiments, outflow sensor  44  may be packaged together with irrigation sensor  46  in a common housing, system  10  may instead include a single sensor coupled with outflow line  28  capable of monitoring both a property indicative of an amount of effluent  18  drained from bladder  16  and a property indicative of the irrigation status, or irrigation sensor  46  may be housed within outflow line  28  such that irrigation sensor  46  is replaced when outflow line  28  is replaced. 
     Control device  48  may be structured to output a flow varying control signal to command varying a flow control state of flow varying mechanism  50  based at least in part on data received by one or more of sensors  42 ,  44 ,  46 . Control device  48  may include a memory (not pictured), a control logic  100  (as illustrated in  FIGS. 6-8 , discussed hereinafter), a user interface (not pictured) capable of being displayed on, for example, display screen  54 , and a processor  64 , or a series of processors, structured to perform calculations, execute instructions, communicate with other components of system  10  by, for example, sending or receiving signals, and/or perform other functions designed to facilitate control of system  10 . Processor  64  might include a microprocessor or a field programmable gate array (FPGA), for example. The memory may be communicatively coupled with processor  64  and structured to store data and/or computer-executable instructions. The memory can include RAM, ROM, DRAM, SDRAM, Flash, or still other types of memory. Control device  48  may be a standalone unit structured for and dedicated to monitoring and/or adjusting the inflow rate, though, in other embodiments, control device  48  may be integrally formed with a shared control device structured to monitor or otherwise sense other health-related information of the patient, such as heart rate or blood pressure, or may be structured to perform other functions. 
     Flow varying mechanism  50  may be structured to adjust the inflow rate by selectively restricting a flow of irrigant  14  through inflow line  26 . In some embodiments, flow varying mechanism  50  may additionally and/or alternatively be structured to at least partially adjust the inflow rate by other means. For example, flow varying mechanism  50  may include a pump or vacuum structured to facilitate and/or limit the inflow rate, or may be structured to adjust the height of an IV pole. It will be appreciated that in such embodiments, a flow varying control signal associated with a particular flow control state may be configured to adjust multiple system parameters associated with flow varying mechanism  50 . 
     Flow varying mechanism  50  of  FIGS. 3-5  includes a valve (hereinafter, “valve  50 ”). Valve  50  may include an electrical actuator  66  structured to actuate a pin  68  responsive to a flow varying control signal that may be outputted by control device  48 . The flow varying control signal may energize electrical actuator  66  such that pin  68  is raised or lowered relative to inflow line  26 , thereby blocking or unblocking, inflow line  26 , respectively. In other embodiments, valve  50  may be hydraulically, pneumatically, or magnetically actuated, or may be a different type of valve, such as a cam operated valve, a stepper motor operated valve, a cartridge valve, a needle valve, or any other suitable type of valve structured to vary the inflow rate by any other means, including, for example, pinching, rolling, or the like. Valve  50  may include a plurality of flow control states, with each being associated with a different pin position relative to inflow line  26 . The flow varying control signal may vary an energy state of electrical actuator  66  to change the flow control state of valve  50 , which may correspond with a change in the inflow rate. For example, a third flow control state may be associated with a lower position of pin  68  than a first or a second flow control state, such that a flow varying control signal encoding a command to vary the flow control state to the third flow control state may lower the inflow rate by altering the orientation or position of valve  50  to restrict the flow of irrigant  14  through inflow line  26 . It will be appreciated that, in like embodiments, a particular flow control state may correspond with similar or identical inflow rates across each embodiment. In other embodiments in which one or more components and/or system parameters may differ, like flow control states may correspond with different inflow rates in each embodiment. For example, in one embodiment, a flow control state associated with an inflow rate of 1.1 L/h using a first irrigant may correspond with an inflow rate of 1.2 L/h using a second irrigant where the second irrigant is slightly more viscous than the first irrigant. Similarly, in the present embodiment, a flow control state associated with an inflow rate of 1.1 L/h may be associated with an inflow rate of 1.2 L/h in an embodiment in which, for example, the inflow lumen has a larger diameter than that of inflow lumen  32 . 
     As shown in  FIG. 3 , valve  50  can be seen in the first flow control state, which may be associated with an open configuration in which pin  68  may be raised such that irrigant  14  may be allowed to flow freely through inflow line  26 , unobstructed by valve  50 , which may correspond with a maximum inflow rate in certain embodiments. Referring now also to  FIG. 4 , valve  50  can be seen in the second flow control state, which may be associated with a partially lowered orientation in which pin  68  is lowered such that the flow of irrigant  14  through inflow line  26  may be partially obstructed but not stopped completely. Referring now also to  FIG. 5 , valve  50  is shown in the third flow control state, which may be associated with an orientation of valve  50  in which pin  68  may be fully lowered such that inflow line  26  is completely obstructed, thereby preventing or ceasing the flow of irrigant  14  through inflow line  26 . Varying the flow control state may therefore vary the inflow rate in a manner consistent with the disclosure herein. It will be appreciated that in other embodiments, valve  50  may have a much greater number of flow control states, and that control device  48  may be structured to factor in one or more system parameters when outputting a flow varying control signal such that commanding the varying of the flow control state may adjust the inflow rate towards a target inflow rate. 
     Referring now also to  FIG. 6 , a flowchart illustrating process and control logic flow to determine a flow varying control signal for adjusting the flow control state is shown. Control device  48  may consider data from sensors  42 ,  44 ,  46  and may be configured by way of control logic  100  to adjust the flow control state in response. Control logic  100  may cause, when executed, control device  48  to perform a flow discrepancy process for detecting an adverse bladder condition, and a titration process for determining the irrigation status. Control device  48  may also be configured by way of control logic  100  to determine a flow discrepancy at block  102 . In the flow discrepancy process, control device  48  may monitor data indicative of the inflow rate and data indicative of the outflow rate to detect the presence and/or measure the degree or magnitude of a discrepancy between the flow or amount of irrigant  14  supplied to bladder  16 , and the flow or amount of effluent  18  drained from bladder  16  (hereinafter, “flow discrepancy”). As discussed above, irrigant  14  is typically continuously supplied to bladder  16  during a procedure and, in a normally proceeding procedure, the amount or flow of irrigant  14  supplied to bladder  16  should correspond with the amount or flow of effluent  18  drained from bladder  16 . Control device  48  may also factor in and/or calculate a rate and/or volume of urine production to learn of the flow discrepancy. A flow discrepancy of a certain magnitude may indicate a problem with the procedure that might require assessment and/or action by a medical professional, such as an adverse bladder condition (e.g., a flow discrepancy may indicate a clot or bladder rupture that may result in irrigant  18  spilling into a body cavity), or it may indicate a problem with a system parameter such as, for instance, an empty irrigant source  20  or a full effluent container  24 . 
     Referring now also to  FIG. 7 , a flowchart illustrating process and control logic flow for the flow discrepancy process is shown. Control device  48  may receive data indicative of the inflow rate from inflow sensor  42  at block  110 , and may receive data indicative of the outflow rate from outflow sensor  44  at block  112 . Control device  48  may then determine a flow discrepancy at block  114  by calculating a difference between the inflow rate and the outflow rate. Learning of the presence or magnitude of a flow discrepancy may allow control device  48  to detect an adverse bladder condition, which may include detecting the presence or absence of an adverse bladder condition, or may indicate an adverse bladder condition is likely or expected to occur. As mentioned previously, the inflow rate and the outflow rate may not be perfectly congruous in many instances as the outflow rate may be expected to exceed the inflow rate because urine  38  mixes with irrigant  14  before draining from bladder  16 . As such, in some embodiments, control device  48  may be structured to calculate an expected flow discrepancy that factors in one or more system parameters, or to query an array of expected flow discrepancies programmed in the memory and select an expected flow discrepancy based on one or more system parameters. Control device  48  may be configured to compare the expected flow discrepancy to an observed or calculated flow discrepancy. In some embodiments, control device  48  may be structured to compare the observed or calculated discrepancy with a threshold flow discrepancy that has been inputted by a medical professional. Should control device  48  learn the flow discrepancy is above a threshold level or outside an expected flow discrepancy, or a range of expected flow discrepancies, control device  48  may log a default and determine an adjustment to the flow control state at block  106 . Once the adjustment to the flow control state has been determined, control device  48  may output a flow varying control signal to adjust the flow control state at block  108 . In determining an adjustment to the flow control state, the magnitude of any flow discrepancy may be considered, as well as the amount, intensity, or magnitude of any other parameters of interest. For example, a significant flow discrepancy (e.g., an observed flow discrepancy of 0.5 L/hr when the expected flow discrepancy was 0.1 L/hr) may be indicative of a bladder occlusion, which may result in control device  48  determining the flow control state should be adjusted to a flow control state similar or identical to the third flow control state illustrated in  FIG. 5  in which valve  50  may be configured to cut off the flow of irrigant  14  to bladder  16 . If, for example, control device  48  calculates or observes only a minor flow discrepancy (i.e., a flow discrepancy below a predetermined threshold, or a discrepancy within an expected range), control device  48  may determine no adjustment to the flow control state is necessary, or that a different adjustment should be made. 
     While control device  48  may be configured by way of control logic  100  to determine a flow discrepancy at block  102  and execute the titration process at block  104  in succession or even concurrently, control device  48  may be structured to at least temporarily prioritize the flow discrepancy process over the titration process or any other process that may be responsive to any other monitored parameter. Should control device  48  learn a flow discrepancy is above a threshold value or otherwise outside of an expected or acceptable range (i.e., a significant flow discrepancy), control device  48  may be structured to determine the flow control state at block  106  and output a control signal at block  108  based only on data resulting from the flow discrepancy process that may be indicative of a bladder occlusion or other adverse bladder condition, such as a flow discrepancy, which may need immediate attention by a medical professional, and which may be complicated further by additional amounts of irrigant  14  supplied to bladder  16 . The alarm may be structured to produce an alarm notification responsive to at least one of the irrigation status or an adverse bladder condition. For example, should control device  48  detect an occlusion, the alarm may be configured to produce an alarm notification in response. In some embodiments, the alarm may be structured to produce an alarm notification responsive to an adjustment of the flow control state. In other embodiments, control device  48  may be structured to output an alarm control signal that in conjunction with or independent of a flow varying control signal. If control device  48  does not detect a flow discrepancy, detects a flow discrepancy is within an expected range, or detects a flow discrepancy below an inputted or predetermined threshold level, control device  48  may be configured by way of control logic  100  to execute the titration process at block  104 . It will be appreciated, however, that the relative importance of the measurements or observations of the flow discrepancy and titration processes may depend on the extent to which the flow rates differ, the extent or nature of the color property of effluent  18 , or any other property measured or observed. In some embodiments, data indicative of the inflow rate, the outflow rate, the color property of effluent  18 , or other properties or parameters may be considered together or in any other manner that would prevent the same or other negative outcomes. For example, a bladder spasm may cause urine  38  to be pushed out of bladder  16  past catheter  22 , which may cause disproportionate inflow and outflow rates but would not indicate a blockage or other complication. In other embodiments, control device  48  of the memory is programmed to execute the titration process and the flow discrepancy process in any other order. 
     Referring now also to  FIG. 8 , a flowchart illustrating process and control logic flow for executing the titration process  104  is shown. In the titration process, control device  48  may receive data indicative of a property of effluent  18  at block  116  to enable control device  48  to determine the irrigation status at block  118 , which may indicate that irrigation of bladder  16  is proceeding as expected or if the inflow rate should be adjusted. In the exemplary disclosed embodiment discussed herein, the property of effluent indicative of an amount of blood in effluent  18  is a color property such as a concentration or intensity of a red color. The presence of a red color in effluent  18  may be caused by the presence of blood, which could result from a low inflow rate or excess bleeding. Put differently, the presence of a red color in effluent  18  of a certain concentration or intensity may indicate the bladder  16  is not being sufficiently irrigated, which may cause an amount of blood to drain from bladder  16  with effluent  18 , and which may lead to clots that cause a bladder occlusion or other adverse bladder condition. Conversely, a low intensity or concentration of reddish color in effluent  18  may indicate an undesirably high inflow rate, which may potentially cause bladder  16  to become overfilled, and can lead to wasting irrigant  14 , for instance. Control device  48  may also be configured by way of control logic  100  to determine an adjustment of the flow control state at block  106  by calculating or retrieving the target inflow rate and then adjusting the flow control state to a flow control state that corresponds therewith. The target inflow rate may be the inflow rate, or the range of inflow rates, suitable for titrating effluent  18  to produce a desired color property of effluent  18  consistent with a recommended therapy protocol. For example, effluent  18  having a rose color typically indicates irrigant  14  is being supplied to bladder  16  at a rate suitable to prevent both clotting and overfilling. The amount of any increase or decrease in inflow rate may depend on the concentration or intensity of the of the color property measured by irrigation sensor  46 . Put differently, the inflow rate may be increased or decreased responsive to an intensity or a concentration of the red color sensed in effluent  18  such that the intensity or concentration of the red color increases or decreases to a desired level or range of levels. Control device  48  may be configured by way of control logic  100  to then output a flow varying control signal at block  108  that encodes for the determined adjustment to the flow control state. Some cycles of control logic  100  may not result in the varying of the flow control state and therefore no flow varying control signal may be generated if, for instance, the flow discrepancy process does not indicate a bladder occlusion and the titration process indicates the inflow rate is property titrated. Alternatively, a flow varying control signal could be produced but cause no change in the flow control state. Control device  48  may be programmed to run control logic  100  in a cyclical fashion at a predetermined interval, such as every 15-30 seconds, every minute, every hour, or any other desired interval. In some embodiments, the cycle period may be dependent on or otherwise factor in one or more system parameters, for example, if a bladder occlusion is suspected, an increased risk of bleeding or clot formation, or the patient&#39;s age or weight, control device  48  may be programmed to increase the frequency with which control logic  100  is run. 
     The present description is for illustrative purposes only, and should not be construed to narrow the breadth of the present disclosure in any way. Thus, those skilled in the art will appreciate that various modifications might be made to the presently disclosed embodiments without departing from the full and fair scope and spirit of the present disclosure. It will be appreciated that certain features and/or properties of the present disclosure, such as relative dimensions or angles, may not be shown to scale. As noted above, the teachings set forth herein are applicable to a variety of different procedures and/or conditions having a variety of different medical applications than those specifically described herein. Other aspects, features and advantages will be apparent upon an examination of the attached drawings and appended claims. As used herein, the articles “a” and “an” are intended to include one or more items, and may be used interchangeably with “at least one.” Where only one item is intended, the term “one” or similar language is used. Also, as used herein, the terms “has,” “have,” “having,” or the like are intended to be open-ended terms.