Estimated excess fluid based fluid therapy and related systems and methods - Patents.com

Abstract

The present technology includes devices, systems, and methods for managing a patient's urination. In some embodiments, an exemplary method includes receiving an estimate of excess fluid for a patient, obtaining a urination rate for the patient, obtaining a diuretic administration rate for the patient, obtaining (i) a first input corresponding to a percentage of an actual amount of net fluid loss relative to the estimated amount of excess fluid and / or (ii) a second input corresponding to an estimated amount of fluid remaining, and providing an output associated with adjusting fluid therapy based on the first input and / or the second input. Providing the output can include providing a display having instructions for increasing the patient's urination by administering additional diuretic and / or by increasing infusion of rehydration fluid to the patient.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is related to U.S. patent application Ser. No. 17 / 112,925, filed December 4, 2020, and claims priority to U.S. Provisional Patent Application No. 63 / 220,880, filed July 12, 2021, the disclosures of each of which are incorporated herein by reference in their entireties.

[0002] FIELD OF THE DISCLOSURE The present disclosure relates generally to medical devices, and more particularly to systems for providing fluid therapy, and related methods and devices. [Background technology]

[0003] The human physiological system naturally attempts to maintain a balance between fluid intake and fluid excretion. An imbalance in fluid intake and excretion rates can cause the body to retain an excessive amount of fluid, also known as fluid overload. Fluid overload can be caused by acute decompensated heart failure (ADHF), chronic heart failure (CHF), or other diseases in which insufficient fluid is excreted. Patients who exhibit fluid overload can suffer from shortness of breath (dyspnea), edema, high blood pressure, and other undesirable medical conditions. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] U.S. Patent Application Serial No. 17 / 659,393 Summary of the Invention [Problem to be solved by the invention]

[0005] To treat fluid overload, patients are typically administered diuretics that induce and / or increase urine production, i.e., reduce the amount of fluid and sodium in the body. Urination rates may be carefully monitored and / or controlled for safety reasons, e.g., to avoid placing undue stress on the patient's kidneys. Different patients may respond differently to treatment, such that the same diuretic type and / or dosage may result in dramatically different urination rates. However, conventional systems and methods for treating fluid overload may not be able to accurately monitor a patient's urination and / or respond to changes in urination. In addition, conventional treatment systems and devices may not be able to induce high urine production rates. Thus, there is a need for improved fluid therapy systems and methods.

[0006] The features, aspects, and advantages of the presently disclosed technology can be better understood with reference to the following drawings. [Brief description of the drawings]

[0007] [Figure 1A] 1 is a partial schematic diagram of a fluid management system configured in accordance with an embodiment of the present technology; [Figure 1B] 1 is a partial schematic diagram of a fluid management system configured in accordance with an embodiment of the present technology; [Diagram 2] 1 is a flow diagram of a method of treating a patient according to an embodiment of the present technology. [Figure 3A] 1 is a flow diagram for managing a patient's urination based at least in part on a target fluid loss of the patient in accordance with an embodiment of the present technology; [Figure 3B] 1 is a flow diagram for managing a patient's urination based at least in part on a target fluid loss of the patient in accordance with an embodiment of the present technology; [Figure 3C] 1 is a flow diagram for managing a patient's urination based at least in part on a target fluid loss of the patient in accordance with an embodiment of the present technology; [Figure 4]1 is a flow diagram of a method of treating a patient according to an embodiment of the present technology. [Diagram 5] 1 is a flow diagram of another method of treating a patient according to an embodiment of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0008] Those skilled in the art will appreciate that the features shown in the drawings are for illustrative purposes and that variations are possible, including different and / or additional features and arrangements thereof.

[0009] The present technology relates to systems, devices, and / or methods for managing (e.g., increasing or decreasing) a patient's urination based at least in part on the patient's estimated amount of excess fluid, and embodiments of the present technology relate to infusing diuretics and / or rehydration fluids to increase or optimize urination from a patient. While standard treatment protocols can be effective for most patients, some patients may have inherent diseases and / or abnormal responses to standard treatment protocols that prevent or inhibit optimal therapy. As an example, certain patients may not respond to some diuretics and / or may have underlying diseases (e.g., low blood pressure or high blood pressure) that limit their urination rate or make treatment to achieve a maximum urination rate more difficult. For such patients, additional steps or protocols may be required to increase urination and alleviate the fluid overload condition.

[0010] As described herein, embodiments of the present technology can manage a patient's fluid therapy and urination based on (i) a first input corresponding to a percentage of an actual amount of net fluid loss relative to an estimated amount of excess fluid for the patient (e.g., an estimated amount of excess fluid remaining and / or to be removed from the patient), and / or (ii) a second input corresponding to an estimated amount of excess fluid retained by the patient (i.e., remaining in the patient). If the first input is at or above a predetermined percentage threshold (e.g., 60%, 70%, or 80%) or if the second input is at or below a predetermined fluid threshold (e.g., 0.5 liters (L), 1.0 L, 1.5 L, or 2 L), the system can determine that the urination and / or fluid loss for the patient is sufficient and that therapy should be stopped (e.g., automatically stopped) immediately or after a period of time (e.g., 1 hour). Alternatively, if the first input is below a predetermined percentage threshold and the second input is above a predetermined fluid threshold, the system can determine that urination and / or fluid loss is insufficient and can take steps to improve fluid therapy. As a particular example, if less than 80% of the estimated amount of excess fluid has been removed and more than 1 L of fluid remains to be removed from the patient, the system can take steps to augment therapy. In such an embodiment, the system can provide an output or recommendation (e.g., through software, labeling, etc.) to infuse a second diuretic in addition to the first diuretic already being infused and / or to increase the rate of rehydration fluid infusion, both of which steps are configured to increase net fluid loss from the patient or provide other therapy augmentation.

[0011] In some embodiments, the system may simply determine that the patient is urinating lightly and / or trigger an action to increase urination if certain other conditions are also satisfied. For example, the system may determine whether (i) the urination rate over a first time period is below a predetermined urination threshold, and / or (ii) whether the diuretic administration rate over a second time period is above a predetermined diuretic threshold. If both conditions are satisfied, i.e., the urination rate is below the predetermined urination threshold and the diuretic administration rate is above the predetermined diuretic threshold, the system may determine whether to increase the patient's fluid therapy, e.g., based on the first input and the second input.

[0012] In light of the above and as described herein, embodiments of the present technology can beneficially identify whether a patient is under-voiding and take action (e.g., automated action, recommendations, etc.) to improve fluid therapy by augmenting fluid therapy in a manner designed to increase voiding. More broadly, embodiments of the present technology can manage a patient's voiding by ceasing fluid therapy in cases of sufficient fluid loss and improve fluid therapy by increasing voiding in cases of insufficient fluid loss.

[0013] The headings provided herein are for convenience only and are not intended to limit or interpret the scope or spirit of the present technology.

[0014] I. Fluid Management Systems and Methods The present technology generally relates to systems, devices, and associated methods for managing a patient's fluid levels. In some embodiments, the systems, devices, and methods described herein are used to treat a patient for fluid overload. To treat fluid overload, a diuretic that induces and / or increases urine production can be administered to the patient. For example, loop diuretics are diuretics that act on the ascending limb of the loop of Henle in the kidney, and include bumetanide (Bumex®), ethacrynic acid (Edecrin®), furosemide (Lasix®), torsemide (Demadex®), thiazide and thiazide-based diuretics (e.g., chlorothiazide, metolazone), potassium-sparing diuretics (e.g., amiloride, spironolactone), carbonic anhydrase inhibitors (e.g., acetazolamide), and osmotic diuretics (e.g., mannitol). Diuretics can be administered orally as a tablet or as an intravenous (IV) injection. IV diuretics can be used when oral diuretics are no longer effective and / or cannot be absorbed.

[0015] The short-term effect of a diuretic on a patient's urine production can be difficult to predict, especially early in treatment. For example, one patient may produce much less urine than expected for a given diuretic dose, whereas another patient given the same dose may produce a very large amount of urine. Low urine production may prolong treatment time and / or reduce efficacy, whereas high urine production may raise concerns about hypotension, hypovolemia, electrolyte imbalance (e.g., hypokalemia), and / or vital organ damage. High doses of diuretics may also raise concerns about ototoxicity regardless of urinary response. Due to these uncertainties, physicians typically prescribe a conservative (e.g., low) diuretic dosage at first and wait several hours before considering whether to increase the dosage. If the physician determines that a higher diuretic dosage is required, the dosage can be gradually and piecemeal increased until the patient achieves the desired level and / or rate of urination. However, this approach may prolong the time that the patient remains in a fluid overload condition, which may worsen the patient's underlying clinical condition. For example, a conservative treatment procedure may require hours or even days before the patient's urinary output becomes high enough to cause significant fluid loss and alleviate the fluid overload condition. The patient may be hospitalized for several days (e.g., 4-5 days), which can be costly and burdensome. In addition, the long-term therapeutic effect may be limited in duration, and thus, approximately 25% of patients are re-admitted within 30 days for fluid overload.

[0016] The efficacy and safety of fluid therapy may also vary based on patient severity and risk of hypotension. For example, patients may be treated with (i) a single loop diuretic, (ii) a combination of a loop diuretic and a thiazide or thiazide-type diuretic, (iii) a combination of a loop diuretic and one or more thiazide diuretics (e.g., metolazone or amiloride), a potassium-sparing diuretic (e.g., spironolactone, amiloride), a carbonic anhydrase inhibitor (e.g., acetazolamide), and an SGLT2 inhibitor (e.g., empagliflozin), and (iv) ultrafiltration. Without being bound by theory, this list of treatment options is in order of (i) increasing risk of hypotension and other side effects, and (ii) increasing patient severity upper limit for effectiveness; for example, single loop diuretics have only a relatively low risk of hypotension and other side effects, and also only a relatively low severity upper limit for effectiveness (e.g., loop diuretics may have only limited effect in critically ill patients with only very poor renal function), whereas ultrafiltration has a relatively high risk of hypotension and a relatively high patient severity upper limit for effectiveness (e.g., ultrafiltration removes fluid even from patients with no renal function). In light of the desire to minimize risk of hypotension and other side effects in a situation where it is very difficult to accurately access a patient's underlying severity and diuretic responsiveness, it is difficult to determine and provide the most effective therapy.

[0017] To address these and other challenges associated with fluid therapy, the present technology provides systems, devices, and methods for managing a patient's fluid levels while reducing the risk of side effects (e.g., risk of hypotension, etc.). In some embodiments, the present technology can (i) improve the effectiveness, safety, and quality of fluid management treatments, (ii) improve resource management within hospitals and other clinical environments, (iii) rapidly assess whether a patient has diuretic resistance, and / or (iv) increase diuretic efficiency (the amount of urine and / or excreted electrolytes (e.g., sodium) obtained over a given time per mg of intravenously infused diuretic). The embodiments described herein can increase the net removal of fluids and / or electrolytes (e.g., sodium and / or chloride) and can also treat fluid overload conditions in a more efficient manner (e.g., shorter time frames and / or higher net fluid loss). In at least some embodiments, the systems, devices, and methods of the present technology can determine whether a patient's urination rate and / or net fluid loss is as expected and, if not, make adjustments based on predefined guidelines to improve net fluid loss. As an example, embodiments of the present technology can adjust or suggest adjustments to a diuretic (e.g., type of diuretic, combination of diuretics, diuretic administration rate, etc.) and / or a patient's rehydration fluid infusion rate based at least in part on the patient's urination and / or an estimated amount of excess fluid removed from the patient. Administering a second or different diuretic can improve net fluid loss for patients who may be diuretic resistant, thereby alleviating a fluid overload condition. Additionally or alternatively, rehydration fluid can be infused at gradually increasing rates to replace fluid lost by the patient during therapy and reduce or prevent the patient from becoming sodium depleted, diuretic resistant, and / or hypotensive. Thus, embodiments of the present technology can deliver improved fluid therapy by allowing patients to achieve a greater variety of treatment options with less risk of diuretic resistance or hypotension.

[0018] 1A is a partial schematic diagram of a fluid management system ("system 100") for monitoring urination and / or controlling fluid injection into a patient P in accordance with an embodiment of the present technology. System 100 includes a urine collection and monitoring system 110 ("urine system 110"), an automatic hydration fluid injection system 120 ("hydration system 120"), an automatic diuretic injection system 130 ("diuretic system 130"), a controller or control system 140 ("controller 140"), and a display or input / output unit 150 ("display 150"). Controller 140 may be operatively coupled to each of urine system 110, hydration system 120, diuretic system 130, and / or display 150. The system 100 may further include a console or structure 105 ("console 105") that incorporates, houses, and / or otherwise supports all or a portion of the urinary system 110, the hydration system 120, the diuretic system 130, the controller 140, and / or the display 150.

[0019] The urinary system 110 is configured to collect urine from a patient P and / or monitor the patient's urination (e.g., amount and / or rate of urination). The urinary system 110 may include one or more collection containers 112 ("containers 112") configured to hold urine, such as disposable bags or other collection devices. The containers 112 may be fluidly coupled to the patient P through a fluid line 119 (e.g., a tubing line). The fluid line 119 may be connectable to a disposable catheter 118 (e.g., a Foley catheter, a Texas Condom catheter, a PureWick catheter, etc.) placed in or otherwise connected to the patient P's bladder.

[0020] In some embodiments, urine flow through the fluid line 119 is driven by patient urine production, gravity (e.g., patient P's bladder is placed higher than the container 112), and / or a siphon effect between the patient's bladder and the container 112. In other embodiments, the urinary system 110 can include a pump (not shown) operably coupled to the fluid line 119 to actuate urine flow through the fluid line 119 and into the container 112. The pump can be or include any device suitable for pumping fluid, for example, a peristaltic pump. The pump can be used to initiate urine flow from the patient's body at the start of a procedure. The pump can maintain urine flow at a desired flow rate during a treatment procedure, and can be activated continuously and / or periodically (e.g., at a predetermined time period) and / or in response to user input and / or detected problems (e.g., unexpected interruption of urine flow). The pump can be used to clear airlocks and / or other obstructions from the fluid line 119. Additional examples of devices suitable for initially injecting fluid into fluid line 119, pumping urine through fluid line 119, and / or removing an airlock from fluid line 119 are described in U.S. patent application Ser. No. 17 / 659,393, filed April 15, 2022, the entire contents of which are incorporated herein by reference.

[0021] The urinary system 110 may include one or more sensors 114 ("sensors 114") configured to detect the patient's urination (e.g., amount and / or rate of urination). The sensors 114 may be operably coupled to the controller 140 such that the controller 140 may monitor and / or calculate the patient's urination based on data generated by the sensors 114. Urine output may be determined in a number of different ways, such as based on urine flow rate (e.g., through the fluid lines 119 and / or into the container 112), the amount of urine in the container 112 (e.g., based on the weight of the container 112, the level of urine in the container 112, etc.), and / or other properties related to the urine. The sensors 114 may include one or more of a flow sensor, a drip counter, a fluid weight sensor, a fluid level sensor, a float sensor, an optical sensor, an ultrasonic sensor, and / or other sensors known in the art suitable for measuring the amount and / or rate of urination. In the embodiment of FIG. 1A, the sensors 114 are positioned on the console 105. However, in other embodiments, some or all of the sensors 114 may be located at different locations within the system 100, such as on or in the line 119, on or in the container 112, and / or on or in the patient P.

[0022] In some embodiments, the sensor 114 can include at least one sensor configured to measure one or more characteristics of the urine in addition to detecting the patient's urination. For example, the sensor 114 can be configured to measure urine temperature, urine conductivity, urine oxygen saturation, urine specific gravity, and / or the concentration of one or more analytes (e.g., creatinine, sodium, potassium, etc.) in the urine. Such characteristics can, for example, aid in determining the effectiveness of a particular therapy and / or determining whether the patient P is considered to be in or approaching a critical condition. For example, urine conductivity and / or urine electrolytes (e.g., sodium) can indicate whether the patient is responding well to fluid therapy or whether the patient is in a critical condition and fluid therapy should be discontinued. In some embodiments, urine conductivity (alone or in combination with urine specific gravity) is used as a surrogate for measurements of urine sodium and / or other urine electrolytes, e.g., higher urine conductivity can correlate to higher urine sodium concentrations and lower urine conductivity can correlate to lower urine sodium concentrations. As another example, urine temperature measurements (e.g., based on heat loss through fluid line 119) can be used to detect urine flow. Urine temperature can be used as a surrogate for the patient's body temperature, which can then be correlated with the patient's current clinical condition.

[0023] Optionally, the sensors 114 may include at least one sensor configured to monitor the status of the urine collection procedure, e.g., whether urine collection is proceeding normally, whether there is an interruption in urine flow, whether there is an obstruction or leak in the urinary system 110, etc. For example, the sensors 114 may include a leak sensor configured to detect whether there is a leak in the urinary system 110 (e.g., at or near the fluid line 119, the catheter 118, and / or the container 112). A leak may be detected based on a change in urine flow rate, a change in pressure, the presence of moisture, or any other suitable parameter. In some embodiments, the controller 140 is configured to analyze data from the leak sensor and / or other sensors 114 to distinguish between a low urination rate and a leak in the urinary system 110.

[0024] As another example, the sensor 114 can include a pressure sensor configured to measure the fluid pressure in the fluid line 119. The controller 140 can use the pressure measurements to monitor the status of the urine flow and optionally detect whether there is any interruption (e.g., reduction, sudden cessation) or other problem associated with urine collection. In some embodiments, the controller 140 analyzes the pressure measurements to determine whether the interruption is due to low urine flow (e.g., the patient's bladder is empty or nearly empty), an airlock or other obstruction in the fluid line 119, a leak in the urinary system 110, and / or a twist in the fluid line 119 and / or catheter 118. The controller 140 can alert the user when manual intervention is advantageous or required (e.g., to clear the obstruction, repair the leak, remove the twist from the fluid line 119, etc.). In embodiments in which the urinary system 110 includes a pump, the controller 140 can automatically activate the pump and / or increase the pumping speed to clear the obstruction from the fluid line 119.

[0025] The rehydration system 120 may include at least one rehydration fluid source 122 ("fluid source 122", e.g., a bag, bottle, reservoir, etc.) containing a rehydration fluid such as saline (e.g., a premixed saline solution), Ringer's lactate, and / or any other liquid solution suitable for infusion into the patient P. The rehydration fluid may be isotonic, hypertonic, or hypotonic, for example, depending on the patient's condition and / or other treatment requirements. Optionally, the composition of the rehydration fluid (e.g., sodium, chloride, potassium, bicarbonate, etc.) may be altered based on the patient's condition and / or expected or measured electrolyte losses during the treatment procedure.

[0026] The fluid source 122 can be connected to the patient P through at least one fluid line (e.g., an IV line or other tubing), such as a first fluid line 129a and a second fluid line 129b. The fluid source 122 can be operably coupled through the first and second fluid lines 129a-129b to one or more hydration fluid components 124, such as a hydration fluid pump 126 and / or at least one hydration fluid sensor 128 ("fluid sensor 128"), for actuating and / or monitoring the infusion of the hydration fluid. In the illustrated embodiment, the fluid source 122 is fluidly coupled to the hydration fluid pump 126 through the first fluid line 129a, which can pump the hydration fluid into the patient P through the second fluid line 129b. The hydration fluid pump 126 can be or include a peristaltic pump or other pump suitable for infusing fluid into the patient's body (e.g., through an IV route or another route).

[0027] The fluid sensor 128 may be configured to determine the amount and / or rate of rehydration fluid flowing from the fluid source 122 towards the patient P and may include a flow sensor, a pressure sensor, and / or other sensor configured to determine fluid output from the pump 126. Alternatively or in combination, the fluid sensor 128 may monitor the rehydration rate by measuring the pumping speed of the pump 126 (e.g., the revolutions per minute of the pump 126). As discussed elsewhere herein, the controller 140 may be operatively coupled to the rehydration system 120 and may receive sensor data from the fluid sensor 128 to determine the rehydration fluid rate. The controller 140 may control the pumping speed of the pump 126 to control the amount and / or rate of rehydration fluid delivered to the patient P.

[0028] Optionally, the amount of rehydration fluid in fluid source 122 may be monitored based on, for example, weight, volume, fluid level, flow rate, etc. In such embodiments, fluid source 122 may be operatively coupled to additional sensors (not shown) separate from fluid sensor 128, such as a fluid level monitor, a float sensor, a weight sensor, an optical sensor, a drip counter, or a flow measurement sensor. The additional sensors may provide an independent source of measurement data for determining and / or verifying the amount and / or rate of rehydration fluid being delivered to patient P, which may help improve the accuracy of the measurements.

[0029] In some embodiments, the hydration system 120 includes at least one sensor, such as a location sensor, a light sensor, a weight sensor, etc., configured to detect the presence of the fluid source 122. The hydration system 120 can use the sensor data to automatically determine whether the fluid source 122 is present or absent, thereby assessing, for example, whether the system 100 is ready to begin a fluid therapy treatment. Optionally, the sensor data can be used to detect during a treatment procedure whether a user attempts to remove an empty or nearly empty fluid source 122, for example, to switch to a new fluid source 122. In such an embodiment, the system 100 can automatically pause injection of hydration fluid until the fluid source 122 has been replaced. Thus, a user can switch fluid sources 122 without having to notify the system 100 or manually pause the procedure.

[0030] Diuretic system 130 can be configured to automatically deliver a diuretic to patient P. Diuretic system 130 can include a diuretic source 134 (e.g., a syringe, bag, reservoir, etc.) that includes a diuretic, such as bumetanide (Bumex®), ethacrynic acid (Edecrin®), furosemide (Lasix®), torsemide (Demadex®), and / or other diuretics known in the art, each of which can be part of a fluid solution (e.g., a mixture of saline and a diuretic or other medication). In some embodiments, the diuretic identifier and / or concentration can be received by controller 140 by user input (e.g., with display 150) and / or by scanning a bar code on diuretic source 134 or other diuretic container, and / or by any other suitable technique.

[0031] The diuretic source 134 may be connected to the patient P through a fluid line 139 (e.g., an IV line or other tubing). The diuretic source 134 may be operatively coupled to one or more diuretic components 136 for actuating and / or monitoring diuretic delivery through the fluid line 139. For example, the diuretic component 136 may include a diuretic pump configured to pump a diuretic through the fluid line 139 towards the patient P. The diuretic pump may include a peristaltic pump, a syringe pump, a metered dose pump, or other device suitable for delivering a diuretic to the patient P at multiple dosage rates. The diuretic pump may deliver the diuretic according to any suitable delivery profile, for example, at a controlled continuous rate and / or in a controlled bolus delivered at regular intervals through the fluid line 139. Additional details of the diuretic delivery profiles are provided below with respect to FIG. 2.

[0032] In some embodiments, the diuretic pump is or includes a syringe pump having a mechanical syringe or plunger operably coupled to the controller 140 such that the controller 140 causes movement of the syringe to deliver the diuretic to the patient P. The syringe pump can include or be coupled to an actuator that mechanically drives the syringe to control the delivery of the diuretic to the patient P. For example, the actuator can be or include a mechanical actuator such as a nut for turning a screw to drive the syringe. The syringe pump can include or be operably coupled to a sensor for detecting the position of the syringe. Alternatively or in combination, the diuretic pump can include other types of pumps and / or actuators. For example, the diuretic pump can include a motor, a gearbox operably coupled thereto, a sensor (e.g., a tachometer or optical encoder) for measuring the rotation of the motor, and / or a microcontroller configured to control the operation of the motor and monitor the amount of diuretic delivered to the patient P. As another example, the diuretic pump may include an electric motor, e.g., a rotary motor, a linear motor, and / or a series of electrically actuated solenoids, configured to advance liquid from the diuretic source 134 toward the patient P through the line 139.

[0033] In some embodiments, the diuretic component 136 includes one or more diuretic sensors configured to determine the amount and / or rate of diuretic flowing towards the patient P. The one or more diuretic sensors may include, for example, flow sensors, weight sensors, and / or other sensor types configured to determine the amount and / or rate of diuretic delivered from the diuretic source 134. Optionally, the diuretic sensor may measure diuretic delivery based on the output from the diuretic pump, for example, by monitoring the pumping speed (e.g., diuretic pump revolutions per minute, plunger position, etc.). The diuretic component 136 may include additional functional components, for example, an air bubble detector, a pressure sensor, a blood spill sensor (e.g., an ivWatch device), and / or other embedded electronics to provide feedback signals to the controller 140, for example, to ensure accurate diuretic infusion and / or to monitor infusion status.

[0034] The controller 140 is configured to automatically control the infusion of hydration fluid and / or diuretic to facilitate safe and effective diuresis of the patient P (e.g., based at least in part on the patient's urination). The controller 140 may include one or more processors and a tangible, non-transitory memory configured to contain programmable instructions. The controller 140 is operatively coupled to the urinary system 110, the hydration system 120, and / or the diuretic system 130 and may receive data (e.g., sensor data) from and transmit data (e.g., control signals) to various components of these systems. For example, the controller 140 may receive sensor data (e.g., from the sensor 114) from the urinary system 110 to determine and / or monitor the patient's urination. Based on the urination, the controller 140 may determine an appropriate amount and / or rate of diuretic administration to administer to the patient P and may cause the diuretic system 130 to deliver the diuretic accordingly. For example, the controller 140 can determine a pumping rate of the diuretic pump to provide a desired diuretic delivery profile. Similarly, the controller 140 can determine an appropriate hydration fluid infusion rate for the patient P (e.g., based on urine output and / or diuretic administration rates) and cause the hydration system 120 to deliver an appropriate amount and / or rate of hydration fluid. For example, the controller 140 can determine a pumping rate for the hydration fluid pump 126 to achieve a desired hydration fluid infusion rate. The controller 140 can adjust the diuretic administration rate and / or the hydration fluid infusion rate based on an appropriate treatment plan protocol prescribed by a physician and / or administered by the controller 140, for example.

[0035] During the procedure, the controller 140 may receive sensor data from various sensors in the urinary system 110, the hydration system 120, and / or the diuretic system 130 to monitor urination, hydration fluid infusion rates, and / or diuretic administration rates, respectively. The controller 140 may receive sensor data from additional sensors, such as fluid pressure sensors, blood pressure sensors, and air bubble detectors, configured to monitor the patient's status and / or the operational status of the system 100. For example, the controller 140 may be operatively coupled to at least one sensor implanted in, attached to, or otherwise associated with the patient P. The sensors may provide data regarding any of the patient parameters, i.e., pressure levels (e.g., pulmonary artery pressure, left atrial pressure), bioelectrical measurements (e.g., bioimpedance vector analysis (BIVA)), hemoglobin measurements (e.g., non-invasive hemoglobin measurements), urinary oxygen saturation levels, urine composition (e.g., creatinine, sodium, potassium, chloride, etc.), urine temperature, body temperature (e.g., bladder temperature), and oral fluid intake. The controller 140 can use data from any of the sensors described herein to monitor treatment progress (e.g., whether treatment is completed), patient status (e.g., whether the patient is responding well or poorly to treatment), and / or potential safety concerns (e.g., whether diuresis is overly vigorous, whether the patient is experiencing side effects). The controller 140 can adjust rehydration fluid infusion rates and / or diuretic administration rates based on the sensor data. Additionally, the sensor data can provide feedback to the controller 140 to verify or validate the effectiveness of fluid therapy.

[0036] Controller 140 can use other data, such as settings for system 100, user inputs, data indicative of a desired treatment regimen (e.g., a programmed fluid delivery profile of diuretic and / or rehydration fluid over time), and / or other data collected or calculated by controller 140 to monitor and / or control therapy. In some embodiments, the data used by controller 140 includes current and / or historical data regarding patient P, such as the diuretic dose delivered to patient P, the volume or rate of urination, the amount of rehydration fluid infused into patient P, the weight or weight change of patient P at various times during the infusion of diuretic, indicators of the patient's renal function (e.g., estimated glomerular filtration rate (eGFR)), and / or the time that patient P has been treated through system 100.

[0037] Display 150 (e.g., a touch screen, monitor, etc.) may include a user interface configured to receive input from a user and display output to the user. In some embodiments, display 150 is operably coupled to controller 140, such that display 150 may be used to receive user input indicating therapy parameters, such as parameters related to urination, rehydration fluid infusion, and / or diuretic dosage. Treatment parameters may include, for example, a desired fluid balance level (e.g., positive, negative, or neutral fluid balance), a target fluid removal volume (e.g., minimum and / or maximum amount of fluid to be removed), a desired urination level (e.g., total urination volume, maximum, minimum, and / or average target urination rate), treatment duration (e.g., maximum and / or minimum duration of a treatment procedure, projected duration of input balance level and / or urination level), type of rehydration fluid, rehydration fluid infusion rate (e.g., maximum, minimum, and / or average infusion rate), rehydration fluid infusion profile (e.g., a function indicating how the amount and / or rate of rehydration fluid infusion is changed over time), rehydration fluid These can include time limits for infusion (e.g., maximum and / or minimum duration for rehydration fluid infusion), type of diuretic, diuretic dosage (e.g., maximum and / or minimum dosage), diuretic administration rate (e.g., maximum, minimum, and / or average administration rate), diuretic administration profile (e.g., a function indicating how the diuretic dosage and / or administration rate is changed over time), time limits for diuretic delivery (e.g., maximum and / or minimum duration for diuretic delivery), other fluids received by the patient during the procedure (e.g., ingested fluid volume, fluid volumes from other medical agents other than the diuretic and / or rehydration fluid), and / or any suitable combination thereof. Other patient-related inputs may be received by the display 150, including, for example, the patient's gender, weight (e.g., "dry" weight), age, ethnicity, clinical condition (e.g., renal function parameters, electrolyte concentrations such as serum chloride concentration), medical history (e.g., results of previous fluid removal procedures), diagnosis (e.g., ADHF, CHF), medications (e.g., whether the patient is diuretic resistant), dietary factors (e.g., whether the patient is on a high or low salt diet, oral fluid intake), and the like.

[0038] Alternatively or in combination, user input through display 150 can prompt controller 140 to retrieve treatment parameters (e.g., maximum diuretic dose, maximum sustained diuretic dose, and minimum desired urine rate) from tables and / or other data sources. The data sources can be stored within system 100 (e.g., in memory associated with controller 140) and / or can be stored on a separate device (e.g., a remote computing device). In some embodiments, controller 140 retrieves data from a remote database and / or server over a communications network (e.g., a wired network, a wireless network, a cloud-based network, the Internet, and / or any combination thereof). In such embodiments, controller 140 can be operably coupled to a communications device and / or interface configured to transmit and receive data over a communications network.

[0039] The controller 140 can output therapy parameters to the user via the display 150 for review and / or feedback purposes. For example, the display 150 can show recommended therapy parameters for the patient P, such as recommendations regarding diuretic administration rates (e.g., initial, maximum, and / or minimum administration rates), recommendations regarding rehydration fluid infusion rates (e.g., initial, maximum, and / or minimum infusion rates), recommendations regarding urination rates (e.g., maximum and / or minimum excretion rates), recommendations regarding treatment duration (e.g., maximum duration for diuretic and / or rehydration fluid infusion, maximum total treatment duration), and the like. As another example, the display 150 can output one or more predefined therapy programs, so that the user can select an appropriate program for a particular patient P. Optionally, the user can modify any of the displayed therapy parameters as desired.

[0040] During a treatment procedure, the controller 140 can output information regarding the procedure status to the user via the display 150. For example, the controller 140 may display information regarding any of the following: urination (e.g., current urination rate and / or volume, urination rate and / or volume over time, total urination volume to date), rehydration fluid infusion (e.g., current infusion rate and / or volume, infusion rate and / or volume over time, total rehydration fluid volume infused to date), diuretic delivery (e.g., current administration rate and / or volume, administration rate and / or volume over time, total diuretic volume delivered to date), fluid balance (e.g., current fluid balance, fluid balance over time, net fluid removal to date), system status (e.g., amount of rehydration fluid remaining in the fluid source 122, amount of diuretic remaining in the diuretic source 134, remaining storage capacity in the container 112), therapy time (e.g., therapy start time, predicted and / or planned therapy end time, total therapy duration to date), and notifications (e.g., warnings, alarms, error messages). The user can review the displayed information and, if appropriate, provide inputs that instruct the controller 140 to adjust, pause, and / or stop the treatment procedure.

[0041] In some embodiments, the system 100 includes redundancy in the urine system 110, the hydration system 120, and / or the diuretic system 130 to reduce or minimize interruptions in therapy due to, for example, exhausting urine collection volume, exhausting hydration fluid, and / or exhausting diuretic. For example, the system 100 can include redundant components (e.g., the container 112, the fluid source 122, and / or the diuretic source 134) that can be stored in a predetermined location (e.g., on or in the console 105 or another portion of the system 100). The controller 140 can be configured to detect the presence of redundant components and can automatically or semi-automatically switch between these components, so that the therapy procedure can continue uninterrupted or substantially uninterrupted. Alternatively or in combination, the system 100 can adjust the timing of user alerts regarding urine collection volume, rehydration fluid levels, and / or diuretic levels based on the availability of redundant components. For example, if a redundant component is available, the system 100 can automatically switch to using the redundant component, or can issue an alert at a later point in time (e.g., closer in time to when the container 112 is believed to be full, the fluid source 122 is believed to be empty, and / or the diuretic source 134 is believed to be empty) so that this switch can be accomplished quickly using redundant components pre-stored locally on the system 100 rather than the user having to seek out a replacement elsewhere.

[0042] The lack of interruptions in fluid therapy can help ensure the effectiveness of fluid therapy, for example, by safely relieving a patient's fluid overload condition as quickly as possible. In some embodiments, even short interruptions in diuretic delivery and / or rehydration fluid infusion can significantly affect a patient's urination (e.g., slowing urination rate), thereby impeding therapeutic efficacy and lengthening therapy time. In some embodiments of the therapeutic procedures described herein, the concerns discussed above regarding a backup supply of diuretic and / or rehydration fluid can be unique to the present technology due to, for example, the relatively large amounts of diuretic and / or rehydration fluid utilized over an extended period of time. That is, whereas conventional systems and methods may utilize only a single diuretic source and / or a single rehydration fluid source by administering only a relatively small amount of diuretic and / or rehydration fluid, the present technology can benefit from multiple diuretic and / or rehydration fluid sources to ensure continuity of therapy. Similarly, the treatment procedures of the technology of the present invention may produce larger urination volumes and / or higher urination rates in the patient P as compared to conventional procedures, and thus multiple containers 112 may be beneficial in reducing the number of times a user must empty and / or replace the containers 112 during the procedure.

[0043] For example, in some embodiments, the urinary system 110 includes two or more redundant containers 112 to ensure that fluid therapy does not have to be stopped or interrupted due to the containers 112 being full. In such embodiments, the urinary system 110 can include a flow control assembly 116 (e.g., valves and / or other flow control components) operably coupled to the controller 140 and configured to selectively direct urine from the patient P to one or more of the containers 112. The flow control assembly 116 can initially direct urine received from the patient P to a first container 112. Upon detecting or determining (e.g., based on sensor data from the sensor 114) that the first container is full or nearly full, the flow control assembly 116 can redirect urine received from the patient P to a second container 112. While urine is being directed to the second container 112, a user can empty the first container 112 or replace the first container 112 with an empty container 112. The flow control assembly 116 and / or the controller 140 can generate a warning to the user indicating that the first container is full and needs to be replaced or emptied. This process can be repeated to ensure that the fluid management therapy is not inadvertently interrupted due to the container 112 being full and / or the urinary system 110 being unable to accept urine output. In some embodiments, the treatment procedures described herein result in relatively large and / or rapid urination volumes (e.g., compared to conventional therapy), and therefore automatic switching between multiple urine containers is advantageous to minimize interruptions in therapy. Additional details of the urinary system 110 and multiple containers 112, as well as related devices and methods, are described below with reference to U.S. Patent Application No. 17 / 659,393, filed April 15, 2022, the entire contents of which are incorporated herein by reference.

[0044] As another example, hydration system 120 may include multiple redundant hydration fluid sources 122, for example, to ensure that hydration fluid infusion can continue uninterrupted throughout a clinical session and / or to provide additional time windows for switching between multiple hydration fluid sources 122 without interrupting hydration fluid infusion. In such an embodiment, hydration system 120 may include a hydration control assembly (e.g., valves and / or other flow control components, not shown) operably coupled to controller 140 and configured to switch the hydration fluid source from the first fluid source to the second fluid source. In such an embodiment, the hydration control assembly may initially deliver hydration fluid from the first fluid source to patient P. The hydration control assembly may monitor whether the first fluid source is empty or near empty, for example, based on data from fluid sensor 128 and / or other sensors associated with hydration system 120. Upon the hydration control assembly detecting or determining that the first fluid source is empty or nearly empty (e.g., the amount of hydration fluid remaining falls below a predetermined threshold), the hydration control assembly can switch to delivering hydration fluid from the second source. This switching process can be repeated to ensure that fluid therapy is not inadvertently interrupted due to an empty fluid source 122 and / or an inability of the hydration system 120 to deliver hydration fluid.

[0045] The process of switching between hydration fluid sources 122 can be performed automatically, semi-automatically, or manually. In some embodiments, semi-automatic or manual switching between the first and second fluid sources can help ensure that the hydration system 120 does not automatically inject hydration fluid without user confirmation. In such embodiments, the hydration control assembly and / or controller 140 can output an alert that queries the user to confirm that hydration fluid should be switched from the first fluid source to the second fluid source. When switching to the second fluid source, the controller 140 can generate an alert to the user indicating that the first fluid source is empty and needs to be replaced. Optionally, the hydration control assembly and / or controller 140 can implement a pre-authorization procedure that allows the user to allow the hydration system 120 to automatically inject a specified volume of additional hydration fluid. Once that volume has been delivered to the patient P, the user may be required to provide re-authorization before further automatic hydration fluid injection.

[0046] In some embodiments, the different fluid sources 122 of the rehydration system 120 each provide the same type of rehydration fluid. However, in other embodiments, some or all of the fluid sources 122 may provide different types of rehydration fluid. The rehydration fluids may differ from one another with respect to tonicity, composition, electrolyte content, etc. Depending on the patient's response to diuresis, the rehydration system 120 may deliver multiple different rehydration fluids to the patient P, either sequentially or simultaneously. For example, if the patient's urination indicates that the patient P has an electrolyte imbalance (e.g., a positive sodium balance), the rehydration system 120 may switch to delivering a rehydration fluid that is believed to address this imbalance (e.g., a rehydration fluid having a lower sodium content). This switching may be performed using any of the techniques and / or devices described above. That is, the particular fluid or fluids delivered to the patient P may be tailored to the patient's particular clinical condition and / or response to treatment.

[0047] In some embodiments, the diuretic system 130 can include one or more sensors configured to detect whether a backup syringe pump is available for use. In yet another example, the diuretic system 130 can include multiple redundant diuretic sources 134, for example, to ensure that diuretic delivery can continue uninterrupted throughout the clinical session and / or to provide additional time windows for switching diuretic sources 134 without interrupting diuretic delivery. For example, if a first diuretic source 134 (e.g., a first syringe or container) is exhausted, the second diuretic source 134 (e.g., a second syringe or container) can continue to provide diuretic (e.g., without substantial interruption). The second diuretic source 134 can be connected to the console 105 and operably coupled to a sensor (e.g., a location sensor, a light sensor, a weight sensor, etc.) configured to detect the presence of the second diuretic source 134. That is, the diuretic system 130 can switch to the second diuretic source 134 when the first diuretic source 134 is empty or nearly empty and the second diuretic source 134 is present.

[0048] In some embodiments, the diuretic system 130 includes two independent diuretic pumps, each including its own diuretic supply source 134. For example, the diuretic system 130 may include syringe pumps, each fluidly coupled to its own diuretic-filled syringe. In some cases, such syringes may only be filled by a pharmacist or other medical personnel and therefore may not be easily replaced (e.g., in less than a few hours) by a user. When the diuretic system 130 and / or the controller 140 detect that the first diuretic supply source 134 is empty or nearly empty (e.g., falls below a predetermined threshold), the diuretic supply may be switched (e.g., automatically or manually) to the second diuretic supply source 134. The switching process may include stopping the first syringe pump fluidly coupled to the first syringe and starting the second syringe pump fluidly coupled to the second syringe. In other embodiments, the diuretic system 130 includes a single diuretic pump (e.g., a syringe pump) connected to the diuretic source 134. In such embodiments, switching between the first diuretic source 134 and the second diuretic source 134 may include switching the diuretic pump from delivering diuretic from the first diuretic source 134 to delivering diuretic from the second diuretic source 134 using a diuretic control assembly (e.g., valves and / or other flow control components). This switching process may be repeated to ensure that fluid therapy is not inadvertently interrupted due to the diuretic source 134 being empty and / or the diuretic system 130 being unable to provide diuretic.

[0049] The process of switching diuretic sources 134 can be performed automatically, semi-automatically, or manually. In some embodiments, manual or semi-automatic switching between the first diuretic source 134 and the second diuretic source 134 can help ensure that the diuretic system 130 does not automatically inject large amounts of diuretic without user confirmation. In such embodiments, the controller 140 can output a warning that asks the user to confirm that diuretic should be switched from the first diuretic source 134 to the second diuretic source 134. When switching to the second diuretic source 134, the controller 140 can generate a warning to the user indicating that the first diuretic source 134 is empty and needs to be replaced. Optionally, the controller 140 can predict the point and / or time range when the first diuretic source 134 will be depleted (e.g., based on the diuretic administration rate) and can output a notification so that the user can order or otherwise provide a replacement diuretic source 134 before the first diuretic source 134 is depleted. Additionally, the diuretic control assembly and / or controller 140 can implement a pre-authorization procedure that allows the user to allow the diuretic system 130 to automatically deliver a specified additional dose of diuretic. Once that dose has been delivered to the patient P, the user may be required to provide re-authorization before further automatic diuretic delivery.

[0050] In some embodiments, the different diuretic sources 134 of the diuretic system 130 each provide the same type of diuretic. However, in other embodiments, some or all of the diuretic sources 134 may provide different types of diuretics. Depending on the patient's response to diuresis, the diuretic system 130 may deliver multiple different diuretics to the patient P, either sequentially or simultaneously. For example, the diuretic system 130 may initially deliver a first diuretic from the diuretic source 134 to the patient P. If the patient P responds inadequately to the first diuretic (e.g., urination rate does not increase or increases only very slowly), the diuretic system 130 may switch to delivering a second, different diuretic from the second diuretic source 134. The diuretic system 130 can continue to deliver the first diuretic simultaneously with the second diuretic, or can cease delivery of the first diuretic when the second diuretic is delivered. This switching can be performed using any of the techniques and / or devices described above. As another example, the diuretic system 130 can simultaneously administer multiple diuretics to the patient P if the patient P does not respond well to a single diuretic. The ratio of the different diuretics can be changed as needed to induce an appropriate urination rate. However, in other embodiments, rather than automatically administering additional diuretics, the diuretic system 130 can output a notification recommending that the user manually administer a different diuretic to the patient P and / or requesting that the user approve the administration of a different diuretic, which can be beneficial to the patient's safety.

[0051] The system 100 shown in FIG. 1A can include many different methods. For example, the locations of various components of the system 100 can be changed, e.g., the urinary system 110, the hydration system 120, and / or the diuretic system 130 can be in different locations within the console 105. As another example, any one of the urinary system 110, the hydration system 120, or the diuretic system 130 can be part of a separate system or device (e.g., a separate console) or can be omitted entirely. For example, in some embodiments, the urinary system 110 is replaced with a mechanism that is intended to monitor the patient's urination and does not require a catheter 118 and / or urine collection, e.g., an ultrasonic sensor that measures the patient's bladder volume. The ultrasonic sensor can be implemented as a patch or similar device that is coupled to the patient's body. The controller 140 can process the ultrasonic sensor data to detect changes in bladder volume and can determine the corresponding amount and / or rate of urination based on the bladder volume. The use of a non-invasive urine monitoring mechanism, such as an ultrasound sensor, may enable the therapeutic procedures described herein to be performed in an outpatient and / or home environment, and may allow the urine bag to be emptied without interfering with continuous and / or intermittent (e.g., every minute, every two minutes, etc.) measurement of urine flow or volume.

[0052] As another example, in some embodiments, the rehydration system 120 is omitted, and thus diuresis is performed without rehydration fluid infusion, or rehydration fluid is manually infused. Diuresis with rehydration fluid infusion may be more beneficial for patients with low serum chloride concentrations (e.g., patients on a low salt diet), whereas patients with high serum chloride concentrations (e.g., patients on a high salt diet) may tolerate diuresis with little or no rehydration fluid infusion. Optionally, the rehydration fluid infusion rate may be altered based at least in part on the patient's serum chloride concentration, for example, a smaller amount and / or a slower rate of rehydration fluid infusion may be used when the patient's serum chloride concentration is high (e.g., greater than or equal to 105 mmol / L).

[0053] In yet another example, the diuretic system 130 may be omitted, and thus diuresis is not performed or is performed manually. In such an embodiment, the system 100 may provide automatic fluid exchange via the hydration system 120 and / or automatically monitor the patient's urination via the urinary system 110, but the diuretic would be administered manually by a medical practitioner according to techniques known to those skilled in the art.

[0054] FIG. 1B is a partial schematic diagram of another fluid management system 160 ("system 160") for monitoring urination and / or controlling fluid injection into patient P according to an embodiment of the present technology. As shown in FIG. 1B, system 160 can include many of the same features as system 100 (as previously described with reference to FIG. 1A), including a console 165 (e.g., console 105, FIG. 1A) and a container 112 having a drainage valve 113, a catheter 118, a fluid line 119, and a controller 140. System 160 can further include a flow control device 138 (e.g., a pinch valve) and multiple sensors for monitoring urine production, some of which can be redundant sensors. Flow control device 138 can be operably coupled to controller 140 and configured to regulate flow from the patient to container 112. In some embodiments, flow control device 138 includes a pinch valve that regulates flow by externally pinching fluid line 119. 1B, the flow control device 138 is upstream of the first sensor 114a. However, in other embodiments, the flow control device 138 can be downstream of the first sensor 114a.

[0055] The sensors 114 may include (i) a first sensor 114a (e.g., a flow sensor, a thermal flow sensor (e.g., Sensirion SLF3x liquid flow sensor), a mechanical paddle wheel type flow sensor, an ultrasonic flow sensor, etc.) coupled (e.g., fluidly coupled) to the fluid line 119 and the catheter 118 and configured to measure a urine flow rate from the patient P, and (ii) a second sensor 114b (e.g., a weight sensor) coupled to the container 112 and configured to measure a weight of the container 112. The first and second sensors 114a-114b may be operably coupled to the controller 140. In embodiments in which the first sensor 114a includes an ultrasonic flow sensor, the ultrasonic flow sensor may be disposed external to the fluid line 119 and therefore does not contact the fluid within the fluid line 119.

[0056] As disclosed elsewhere herein, signals regarding urine production from the patient can be used by the system to determine, for example, how much diuretic and / or rehydration fluid to administer (e.g., automatically controlled administration of diuretic and / or rehydration fluid). It can therefore be beneficial to obtain an accurate and reliable urination signal. In such an embodiment, a signal from the first or second sensor 114a-114b can be compared to a signal from the other of the first or second sensors 114a-114b to ensure accuracy of the measurement. Signals can be obtained at regular intervals (e.g., every second, every 30 seconds, every minute, every 2 minutes, every 5 minutes, every 10 minutes, etc.) and these signals can be used to provide an average flow rate on a recurring basis or to calculate a total urine volume over a given period of time. For example, based on the signals obtained from the first and second sensors 114a-114b, an average flow rate or patient urination rate can be determined and continuously updated, for example, for the previous minute.

[0057] In some embodiments, the signal from the second sensor 114b can be used as a primary source or input, and the signal from the first sensor 114a can be used as a backup or secondary signal source. Alternatively, the signal from the first sensor 114a can be used as the primary source, and the signal from the second sensor 114b can be used as the secondary signal source. The primary source can switch between the second sensor 114a and the second sensor 114b if (e.g., only if) the current sensor serving as the primary source has failed or is unavailable, or other predetermined conditions are met. For example, in some embodiments, the signal from the second sensor 114b can be used as the primary source unless and / or until (i) the weight of the container 112 is greater than a predetermined threshold, indicating that the container 112 is nearly full and needs to be drained; (ii) the weight of the container 112 is decreasing, indicating that the container 112 is likely being drained, thereby compromising the ability of the second sensor 114b to provide accurate urine flow measurements; (iii) the weight of the container 112 is increasing at a slower rate than expected or is decreasing, indicating that the container 112 is being drained, thereby compromising the ability of the second sensor 114b to provide accurate urine flow measurements; and / or (iv) a difference exists between the signals of the first sensor 114a and the second sensor 114b, indicating that the container 112 is being drained and / or one of the signals is not accurate. If one or more of these conditions are met, the system 160 or controller 140 can be configured to (i) select one of the sensors dominantly over the other, and / or (ii) analyze the signals from both sensors to select the most reliable signal based on other operating conditions (e.g., most recently obtained urination rate, average urination rate, diuretic dosage, rehydration infusion amount, etc.).

[0058] In embodiments where a sensor used as a primary source is deactivated, the sensor may not be reactivated until another condition is satisfied. For example, if the signal from the second sensor 114b is removed from being the primary source due, for example, to a decrease in the weight of the container 112, the signal from the second sensor 114b may not re-engage as the primary source until a predetermined condition (e.g., an increase in the weight of the container 112) occurs or until a certain time (e.g., 30 seconds, 1 minute, 2 minutes, etc.) has elapsed after the predetermined condition. If the predetermined condition (e.g., an increase in the weight of the container) is not satisfied after a pre-specified period of time, a warning may be generated indicating to the user that an unexpected condition has been encountered, for example, an indication that the drain valve 113 was not closed or that urine is leaking.

[0059] In some embodiments, discrepancies determined between the first sensor 114a and the second sensor 114b may identify a potential fault in the system (e.g., a faulty sensor) and cause the system 160 to stop all or part of the fluid therapy and / or warn the user that such discrepancies exist. In some embodiments, depending on which and / or how long the first or second sensor 114a-114b has been offline or determined to be inaccurate, the system 160 or controller 140 may modify other aspects of the therapy administered to the patient. For example, the amount of diuretic and / or rehydration fluid provided to the patient may be maintained or reduced. In some embodiments, the first and second sensors may be tested during preparation of the system 160 for connection to the patient such that if a failure of any of the sensors 114a-114b is detected or if there is a significant discrepancy between the readings of the first sensor 114a and the second sensor 114b, a warning may be issued prior to initiation of therapy to prevent use of the system 160 in a non-functional state.

[0060] In some embodiments, the first sensor 114a (i.e., flow sensor) is omitted and the second sensor 114b (i.e., weight sensor) is relied upon to provide a urinary flow output from the patient. In such embodiments, utilizing sensor data obtained from the second sensor 114b, an average urinary flow rate over a period of time is determined based, for example, on the rate of change of the weight of the container 112. Further, in such embodiments, when the system 160 determines through the second sensor 114b that the weight of the container 112 is decreasing or not increasing at an expected rate, which may indicate that the container 112 is being drained, the system may ignore the signal from the second sensor 114b for a predetermined period of time (e.g., 1 minute, 2 minutes, 5 minutes, etc.) and then again rely on this signal to provide a urinary flow output. During this predetermined period of time, the diuretic and / or rehydration fluid provided to the patient may be maintained and / or reduced.

[0061] Advantageously, the system 160 and other embodiments of the present technology can remain operational and provide therapy even when the container 112 is replaced and / or emptied. For example, the first sensor 114a is upstream of the container 112 and can be a flow sensor that is not dependent on the weight of the container, so that the patient's urination can be monitored while the container is being replaced and / or emptied. Thus, unlike other embodiments that only have a sensor configured to measure the weight of the container 112 and therefore cannot provide accurate urination measurements when the container is being replaced and / or emptied, embodiments of the present technology allow the system 160 to continue to provide therapy uninterruptedly. Additionally or alternatively, embodiments of the present technology allow medical personnel to drain the container 112 (e.g., through the drain valve 113 of the container 112), which may be prohibited and / or may result in inadvertently interrupting the patient's fluid therapy, without (i) being forced to replace the container 112 or remove the container 112 from the system, and (ii) without using an interface of the system.

[0062] Optionally, system 100 may include or be used in combination with additional systems or devices, such as systems or devices configured to perform any of the following functions: administering drugs and / or medications other than diuretics and rehydration fluids (e.g., heart failure medications), monitoring other patient parameters other than urination (e.g., blood pressure, weight, heart rate, blood oxygen saturation, respiratory rate, temperature), and / or performing other types of medical procedures (e.g., dialysis, ultrafiltration) on patient P simultaneously or sequentially with the fluid removal procedure.

[0063] FIG. 2 is a flow diagram of a method 200 of treating a patient according to an embodiment of the present technology. In some embodiments, the method 200 is used to treat a patient for fluid overload by removing fluid from the patient to create a negative fluid balance (net fluid loss). The method 200 (and other methods described herein) includes one or more steps, blocks, phases, acts, portions, processing portions, or operations, etc. The method 200 may be performed by any of the embodiments of the systems and devices described herein, such as the system 100 of FIG. 1A and / or the system 160 of FIG. 1B. In some embodiments, some or all of the steps of the method 200 are performed by a system or device that includes one or more processors and a memory that stores instructions that, when executed by the processor, cause the system or device to perform one or more of the steps described herein. For example, the method 200 may be performed by the controller 140 of the system 100 of FIG. 1A or the system 160 of FIG. 1B. Optionally, some or all of the steps of method 200 may be performed automatically or semi-automatically with little or no human intervention.

[0064] The method 200 may include obtaining a urination rate from a patient (processing portion 202). The urination rate may be obtained from a urine monitor and / or urine collection system connected to the patient, such as the urinary system 110 of FIG. 1A. The system may determine the urination rate based on received input data, such as data from one or more sensors (e.g., sensor 114 of FIG. 1A and / or FIG. 1B). As described above, the sensor may be configured to measure the urination rate based on flow rate, weight (e.g., of the container 112 of FIG. 1A and FIG. 1B), volume, fluid level, and / or any other suitable parameter. The urination rate may be calculated based on the received input, for example, by a controller (e.g., controller 140 of FIG. 1A and / or FIG. 1B) operably coupled to the sensor. The urination rate may be a current rate or an average rate measured over a predetermined period of time (e.g., the last 5 or 10 minutes). The urination rate may be updated on a continuous or recurring basis (e.g., every 30 seconds, every minute, every two minutes, etc.) In some embodiments, the urination rate is obtained simultaneously with some or all of the other processing portions 204, 206, 208 of the method 200 to provide a continuous or substantially continuous urination monitor throughout the method 200.

[0065] The method 200 can include a step of causing a diuretic to be provided to the patient at a dosage rate (processing portion 204). The diuretic can be or include furosemide, bumetanide, ethacrynic acid, torsemide, combinations thereof, and / or other diuretics known in the art. In some embodiments, the diuretic is delivered as part of a solution that includes saline or other rehydration fluid mixed therewith. The diuretic can be delivered automatically or semi-automatically by a diuretic system connected to the patient, such as diuretic system 130 of FIG. 1A. The diuretic system can be operably coupled to a controller (e.g., controller 140 of FIG. 1A and / or FIG. 1B) to cause diuretic delivery according to a scheduled and / or preprogrammed therapeutic regimen.

[0066] In some embodiments, the treatment protocol includes multiple phases, each phase having a different delivery profile for the diuretic. In such an embodiment, the processing portion 204 may execute as part of an initial phase (also known as a "dose determination phase") that determines an appropriate diuretic administration rate to treat the patient. In the dose determination phase, the diuretic is injected at an initial administration rate, and then the administration rate may be gradually increased to induce an increase in the patient's urination rate. The diuretic administration rate may be increased according to a desired function or delivery profile, such as a continuous function, a step function, or a combination thereof. This function may include iteratively increasing the administration rate linearly, exponentially, according to a polynomial function, and / or any other suitable ramp function or profile. In some embodiments, the diuretic is delivered in a manner such that the subsequent administration rate is a predetermined percentage (e.g., at least 5%, 10%, 15%, 25%, etc.) higher than the most recent administration rate. The predetermined percentage may be increased or decreased over time depending, for example, on the desired fluid therapy and / or patient requirements. Optionally, the diuretic may be delivered in a manner that doubles the diuretic administration rate or total diuretic amount over a range of periods (e.g., 10 minutes, 15 minutes, 20 minutes, or a range of 10-20 minutes). However, in other embodiments, the dosage determination phase may include one or more periods during which the diuretic administration rate is not increased and / or is held substantially constant. The dosage determination phase may continue until the patient's urination reaches or exceeds a desired threshold rate and / or a predetermined period of time has elapsed, at which point the diuretic administration rate may be adjusted as described below with respect to processing portion 208.

[0067] The method 200 can include causing (processing portion 206) to provide a rehydration fluid to the patient at a rehydration rate. The rehydration fluid can include saline and / or other fluids having sodium and can be provided automatically or semi-automatically by a rehydration fluid system connected to the patient, such as the rehydration system 120 of FIG. 1A. The rehydration fluid can be provided before, during, and / or after providing a diuretic in the processing portion 204 (e.g., before, during, and / or after a dosing phase). Intravenous infusion of a rehydration fluid containing electrolytes (e.g., sodium and / or chloride) can increase diuretic efficiency and is counterintuitive in that the goal of fluid therapy is net fluid removal. The rehydration fluid can reduce or inhibit intravascular depletion, reduce or inhibit decline in cardiac output, and / or reduce or inhibit decline in renal perfusion, among other benefits.

[0068] In some embodiments, rehydration fluid is provided to the patient based at least in part on a corresponding urination rate, for example, to drive net fluid loss from the patient. For example, the hydration rate can be lower than the urination rate. In some embodiments, the hydration rate is a percentage of the urination rate (e.g., 90%, 80%, 70%, 60%, 50%, 40%, 30%, 20%, or 10% of the urination rate) over a given range of urination rates (e.g., from 0 ml / hr to 1000 ml / hr). Optionally, the percentage can be higher over certain portions of the range (e.g., over the lower end of the range to reduce the likelihood of hypotension) and / or lower over other portions of the range (e.g., over the upper end of the range to increase net fluid loss). As another example, the hydration rate can substantially match the urination rate (e.g., be 100% of the urination rate) over an initial urination volume by the patient (e.g., at least an initial 150 ml, 200 ml, or 250 ml), and / or over an initial period (e.g., the first hour, 2 hours, or 3 hours), and / or until the patient's urination rate reaches a predetermined threshold. Thereafter, the hydration rate can be adjusted to be less than the urination rate. In yet another example, the hydration rate can be determined based on whether the urination rate is higher or lower than one or more different thresholds, where the difference between the urination rate and the hydration fluid rate increases as the urination rate increases. In such an embodiment, the difference between the urination rate and the hydration fluid rate can increase as the urination rate increases (where the urine rate is higher than the hydration fluid rate), and thus the net fluid loss from the patient can increase as the urination rate increases.

[0069] The method 200 can include adjusting at least one of the administration rate of the diuretic or the rehydration rate of the rehydration fluid, thereby causing a net fluid loss from the patient (processing portion 208). For example, (i) the diuretic administration rate can be adjusted, (ii) the rehydration rate can be adjusted, or (iii) both the diuretic administration rate and the rehydration rate can be adjusted. In some embodiments, the diuretic administration rate is adjusted after the dosage determination phase of the treatment procedure is completed. As discussed above with respect to processing portion 204, the dosage determination phase can end when (i) a predetermined amount of time has elapsed since the initial diuretic administration and / or (ii) the urination rate is greater than or equal to or becomes a predetermined threshold rate. The treatment procedure can then switch to a phase (also known as the "continuous delivery phase" or "fluid reduction phase") of adjusting the diuretic administration rate to an administration rate configured to maintain the patient's urination rate at or above a desired excretion rate to cause a net fluid loss.

[0070] The adjusted diuretic administration rate may be an initial administration rate for the fluid reduction phase and may be determined in many different ways. For example, the adjusted diuretic administration rate may be based on the results of the dose determination phase. The adjusted diuretic administration rate may be lower than or equal to the diuretic administration rate at the end of the dose determination phase (e.g., the administration rate at which the patient's urination reaches or is greater than a target threshold). Reducing the diuretic administration rate may reduce the rate of increase in urination rate (e.g., causing the patient's urination to approach a constant or substantially constant rate), but may do so without actually reducing the urination rate itself. Additionally or alternatively, the reduction in the diuretic administration rate may maintain the patient's urination rate at a predetermined rate and / or within a predetermined range (e.g., not more than a 5%, 10%, or 20% change from the predetermined rate).

[0071] In some embodiments, the adjusted diuretic administration rate is a predetermined percentage of the current administration rate (e.g., the administration rate at the end of the dose determination phase) or a predetermined fraction or a predetermined percentage of the cumulative diuretic dose (e.g., the cumulative amount delivered during the dose determination phase). For example, the adjusted administration rate can be a predetermined percentage (e.g., 10%, 15%, 20%, 25%, 30%, or a range of 10-30%) of the value of the total diuretic dose delivered to the patient at that time. For example, if the total delivery is 100 mg and the predetermined percentage is 25%, the adjusted administration rate can be 25 mg / hr. In some embodiments, the percentage used to calculate the adjusted diuretic administration rate is based on the pharmacokinetic properties of the particular diuretic being infused. For example, for furosemide, this percentage may be 20% so that if 50 mg of furosemide is infused within 60 minutes, the adjusted diuretic administration rate may be 10 mg / hr.

[0072] In some embodiments, the processing portion 208 includes delivering the diuretic at the adjusted diuretic administration rate until the fluid reduction phase is complete, e.g., until a predetermined time period has elapsed and / or until an estimated amount of excess fluid has been removed from the patient and / or until the patient's urine rate drops below a predetermined threshold and the total fluid removed from the patient is greater than the estimated amount of excess fluid. During the fluid reduction phase, the diuretic administration rate can be constant or substantially constant (with no more than a 5%, 10%, or 20% change from the initially determined adjusted diuretic administration rate). However, in other embodiments, the processing portion 208 can include making additional adjustments to the diuretic administration rate during the treatment procedure (e.g., increasing and / or decreasing the diuretic administration rate). These adjustments can be based on whether one or more of a set of predetermined conditions are satisfied, such as whether the urination rate is excessively high and / or increasing. This set of conditions can include (i) the average urine rate is greater than a predetermined rate over a period of time, (ii) the average rate of change in urine rate is greater than a predetermined rate, and / or (iii) the diuretic administration rate is greater than a predetermined administration rate. If some (e.g., two) or all of these conditions are met, the diuretic administration rate can be reduced (e.g., by a predetermined amount or a predetermined percentage), also referred to herein as "down-titrating."

[0073] In some embodiments, the downward titration is performed only when all or most of the above conditions are met, thereby avoiding unnecessary reduction of the diuretic administration rate and thus avoiding unnecessary interruption of the treatment procedure while the urination rate remains high. For example, whereas other approaches may interrupt fluid therapy and reduce the diuretic administration rate (e.g., to zero mg / hr) when the urination rate is even slightly too high, the process described herein may only reduce the administration rate (e.g., to a non-zero or zero administration rate) when the urination rate is high and continues to increase with it. In other words, the process herein may prevent unnecessary reduction of the diuretic administration rate when the urination rate is temporarily high (e.g., higher than a predetermined rate) but trending downward. This approach may prevent or inhibit overdiuresis, excessive fluid loss and / or electrolyte loss, and limit the patient's unnecessary exposure to additional diuretics. In addition to this, the diuretic administration rate can be titrated downward rather than stopping the diuretic completely, so that fluid therapy can continue (albeit at a lower voiding rate) without having to fully restart the procedure.

[0074] As another example, further adjustment of the diuretic administration rate in the processing portion 208 may include increasing the diuretic administration rate, which is also referred to herein as "re-ramping" or "up-titrating." In some embodiments, re-ramping is performed if the urination rate, as determined based on a set of conditions, is too low and / or declining. The set of conditions may include (i) the average urine rate being below a predetermined threshold rate for a predetermined period of time, and / or (ii) a deficit of more than a predetermined amount has accumulated for a predetermined period of time. The "deficit" may be defined as the area between the urination rate and a set rate (e.g., 325 ml / hr) on a plot, and may represent how much and for how long the urination rate has fallen below the set rate. If some or all of these conditions are met, re-ramping may be performed by gradually increasing the diuretic administration rate (i) until a predetermined amount of time has elapsed, and / or (ii) until the urination rate is greater than or equal to the predetermined threshold rate. The re-ramp process may be the same as or substantially similar to the dose determination process described above with respect to processing portion 204.

[0075] The re-ramp process can be performed automatically, semi-automatically, or manually. In some embodiments, re-ramp is a semi-automatic or manual process that requires user approval, for example, for regulatory and / or safety reasons. In such embodiments, the system can output a notice to the user (e.g., via the display 150 of FIG. 1A ) instructing the user to confirm that re-ramp is initiated. Optionally, the system can implement a pre-approval procedure that can allow the user to automatically perform re-ramp under certain conditions (e.g., within a certain time period until a pre-defined voided volume and / or voided rate is achieved, such as for a maximum diuretic dose and / or maximum diuretic administration rate). This approach can allow automatic re-ramp under limited circumstances, which can reduce the amount of human involvement during the treatment procedure and improve the responsiveness of the system to the patient's current condition. Once the pre-approval condition has passed, the user may be required to give re-approval before additional automatic re-ramp is allowed.

[0076] In some embodiments, the processing portion 208 further includes adjusting the diuretic administration rate in response to an obstruction detected in the urine collection system (e.g., an airlock, a kink in a fluid line, etc.). For example, an airlock may be any partial or complete obstruction of fluid flow due to gas (e.g., air) trapped in the fluid system. Examples of situations in which an airlock may occur are described in U.S. Patent Application No. 17 / 659,393, filed April 15, 2022, the entire contents of which are incorporated herein by reference. As described elsewhere herein, an airlock may create an unnatural drop in urination rate, which may affect diuretic administration rate determinations (e.g., resulting in an excessively high diuretic administration rate). In some embodiments, the presence of an airlock is detected based on a period of little or no urination (due to the airlock obstructing urine flow) followed by a sudden large bolus of urination (due to built-up pressure in the fluid line that clears the airlock). Upon detecting that an airlock or other obstruction was or is present, the system can compensate by adjusting the diuretic administration rate to the administration rate that would have been used if the airlock or other obstruction had not occurred. The appropriate administration rate can be determined based on historical data (e.g., the diuretic administration rate before the airlock occurred, the diuretic administration rate calculated from the patient's urination rate before the airlock occurred, the urine volume measured when the airlock was cleared, etc.).

[0077] Alternatively or in combination, the processing portion 208 may include adjusting the hydration rate by, for example, increasing or decreasing the hydration rate based on the patient's urination rate to drive net fluid loss from the patient. For example, as described above, the hydration rate may initially match the patient's urination rate for an initial set of conditions (e.g., a predetermined time period, initial urination volume, and / or initial urination rate). Once the initial conditions have passed, the hydration rate may be maintained at a rate lower than the urination rate (e.g., a percentage of the urination rate) such that the patient exhibits net fluid loss during the fluid reduction phase. The hydration rate may be determined in a variety of ways, such as a percentage or fraction of the patient's urination rate, based on whether the urination rate is higher or lower than some different threshold (e.g., the difference between the urination rate and the hydration rate increases as the urination rate increases), and / or any other suitable approach.

[0078] Optionally, the diuretic administration rate and / or the hydration rate can be adjusted based on factors other than the patient's urination rate. For example, the diuretic administration rate and / or the hydration rate can be adjusted based on the patient's blood pressure to avoid putting the patient in a hypotensive state. In some embodiments, if the patient's blood pressure level is too low (e.g., below a threshold or threshold range), the system can avoid increasing the diuretic administration rate and / or reduce the diuretic administration rate for a predetermined period of time. Alternatively or in combination, the system can increase the hydration rate for a predetermined period of time if a low blood pressure level is detected (e.g., up to a maximum allowable hydration rate and / or to provide a desired fluid exchange profile (e.g., 100% match to the patient's urination rate)). The system can output a warning indicating that the patient's blood pressure level is low, so that the user can check the patient's status. Optionally, the system can take into account both blood pressure levels and urination rate, for example the system can generate an alert if the patient's blood pressure is low and the patient's urination rate drops, and / or adjust diuretic administration rates and / or rehydration rates. This approach can improve patient safety and control of the treatment procedure.

[0079] In some embodiments, some or all of the processing portions of method 200 are performed as part of a medical procedure to treat a patient for a fluid overload condition. Method 200 can be used as a primary sole therapy to treat fluid overload, or can be used in combination with other therapies (e.g., as a post-primary therapy to reduce the likelihood of hospital readmission). Method 200 can be performed in any suitable environment, such as an inpatient or outpatient environment. In embodiments in which method 200 is performed as an outpatient therapy, the overall duration of method 200 can be reduced (e.g., to 10 hours, 5 hours, 4 hours, 3 hours, 2 hours, or 1 hour or less).

[0080] Method 200 shown in FIG. 2 can be modified in many different ways. For example, any of the processing portions of method 200, such as processing portion 204 or 206, can be omitted. In some embodiments, processing portion 204 is omitted, and thus method 200 controls rehydration fluid infusion but does not control diuretic delivery or does not include any diuretic delivery at all. Similarly, processing portion 206 can be omitted, and thus method 200 controls diuretic delivery but does not control rehydration fluid infusion or does not include any rehydration fluid infusion at all. As another example, some or all of the processing portions of method 200 (e.g., any of processing portions 202, 204, 206, and / or 208) can be performed in a different order and / or repeated. In yet another example, method 200 can include additional processing portions not shown in FIG. 2 (e.g., causing delivery of additional drugs, obtaining parameters other than urination rate, etc.).

[0081] The present technology can provide many advantages with respect to treating fluid overload and / or managing a patient's fluid levels. For example, embodiments of the present technology have been shown to consistently reduce fluid volume in a patient more quickly and safely than conventional treatment systems and therapies. For example, while conventional methods may typically require at least five days to remove a net fluid volume of 4-5 L, embodiments of the present technology have been shown to remove a net fluid volume of 4-5 liters within 24 hours. In addition to this, embodiments of the present technology have also been shown to remove significant amounts of salt through hypernatremia from the patient. This salt removal can reduce the likelihood of a patient reaccumulating fluid after discharge, which can lead to reduced re-admission rates. Additionally, embodiments of the present technology can automatically and continuously monitor urination, rehydration fluid infusion, and / or diuretic delivery during a treatment procedure to reduce patient safety concerns (e.g., excessive diuresis and / or hypotension).

[0082] Embodiments of the present technology can provide various benefits such as any of the following: (i) optimizing net fluid volume removal, (ii) reducing the time required to provide a desired net fluid removal by allowing physicians to use higher diuretic doses and / or administration rates early in treatment compared to conventional treatments, (iii) avoiding or reducing the risk of adverse events such as overdiuresis, dehydration, and / or intravascular depletion, (iv) quickly assessing whether a patient has diuretic resistance, and (v) providing treatment data recording.Embodiments of the present technology can obtain an average net fluid removal rate (e.g., average urination rate minus average rehydration fluid infusion rate) of at least 225 ml / hr, thereby providing a net fluid volume removal of 3.4 L per day based on oral or IV infusion introduction of 2 L of fluid per day. This rate of fluid removal while replacing sodium can reduce the overall length of hospital stay and / or allow for improved decongestion.

[0083] II. Estimated Excess Fluid Based Fluid Therapy and Related Systems and Methods 3A-3C are flow diagrams of a system 300 for managing a patient's urination based at least in part on a desired and / or estimated amount of excess fluid to be removed from the patient. Features of the embodiments described in FIGS. 3A-3C are suitable for use with the system 100 of FIG. 1A, the system 160 of FIG. 1B, and / or the method 200 of FIG. 2. Any of the features of the embodiments of FIGS. 3A-3C may be combined with each other and / or incorporated into any of the other embodiments of the present technology. Additionally, any actions or processes described as being performed by the system 300 may be performed automatically by the system 300 and / or in response to one or more inputs from a user based at least in part on the output of the system 300.

[0084] As described elsewhere herein, embodiments of the present technology relate to infusing diuretics and / or rehydration fluids to increase or optimize urination and thus net fluid loss from a patient. As discussed above, standard treatment protocols may be ineffective for some patients with specific conditions (e.g., hypotension or hypertension, diuretic resistance) that may limit maximum urination rate and / or may make treatment to achieve maximum urination rate more difficult. For such patients, different steps or protocols may be required in increasing urination and relieving fluid overload conditions.

[0085] The flow diagrams shown and described with reference to Figures 3A-3C include, for example, a protocol for modifying fluid therapy to suit the above-mentioned patients with underlying conditions. As disclosed elsewhere herein, embodiments of the present technology may begin fluid therapy with an initial "dose determination phase" that determines an appropriate diuretic administration rate, followed by a "continuous delivery phase" that includes an administration rate to maintain the patient's urination at or above a desired urination rate. The system 300 of Figures 3A and 3B may accommodate the continuous delivery phase. With joint reference to Figures 3A and 3B, at the start of therapy, a user (e.g., clinician, medical professional, patient, etc.) may be prompted (processing portion 301) to input an estimated amount of excess fluid, thereby establishing a minimum goal for fluid removal during the therapy. Additionally or alternatively, the system 300 may prompt the user for one or more other inputs related to the patient's fluid status. For example, the system 300 may prompt the user to input a urine specimen and / or volume thereof, the volume or percentage of fluid removed, blood pressure, creatinine concentration and / or changes therein, other physiological indicators and / or symptoms related to heart failure, and / or other physiological parameters. Once the estimated amount of excess fluid and / or other physiological parameters have been received by the system (e.g., system 100), fluid therapy may be initiated by administering a diuretic and / or rehydration fluid. In some embodiments, the initiation of fluid therapy corresponds to the "dose discovery phase" described above with reference to Figures 1A and 2. The amount of estimated excess fluid inputted through fluid therapy may be compared to the actual fluid removed from the patient to determine the percentage of the estimated amount of excess fluid achieved and whether or not a goal will and / or is expected to be achieved within a given period of time. As described elsewhere herein, this percentage may be used by the system to determine whether the fluid loss achieved was either sufficient or insufficient. In cases of insufficient fluid loss and / or low voiding conditions, the system may determine one of the more preferred subsequent actions.Such actions may include recommending infusing a second diuretic in addition to the first diuretic and / or increasing the infusion rate of rehydration fluid (e.g., saline). Additionally or alternatively, this percentage may be used by the system to guide the handling of low urination conditions after a high loop diuretic dose is reached. In cases of low urination prior to achieving a large percentage of the estimated excess fluid volume removal, the system may recommend and / or implement an increase in therapy with the goal of increasing urination. In cases of low urination after achieving a large percentage of the estimated excess fluid volume removal, the system may recommend and / or implement a cessation of therapy.

[0086] In some embodiments, the system may request the user to update the estimated excess fluid amount within a predetermined time (e.g., 12 hours, 18 hours, 24 hours, 26 hours, 29 hours, 30 hours, etc.) to have a current estimate of excess fluid removed from the patient. Before the predetermined time for the estimated excess fluid amount has elapsed, the system may issue a warning indicating that the previously entered estimated excess fluid amount is about to expire, and may repeatedly issue the warning (e.g., every hour) until the estimated excess fluid amount is updated. After the predetermined time for the estimated excess fluid amount has elapsed, the system may warn the user that the estimated excess fluid amount is about to be reached. The system may determine whether the predetermined time for the estimated excess fluid amount has elapsed after a period of time (e.g., every 5 minutes, 30 minutes, 1 hour, 2 hours, etc.). Once the estimated excess fluid amount has been updated, a timer for requesting a current estimated excess fluid amount is reset, and the system may continue to wait for the clinician or other user to update the estimated excess fluid amount. Optionally, the patient's history (e.g., medical history, fluid loss history, etc.) may be displayed with the estimated amount of excess fluid updated. These prompts for user input may also apply to one or more other inputs related to the patient's fluid status. For example, the system 300 may prompt the user to automatically measure or update a urine specimen and / or volume thereof, an amount or percentage of fluid removed, blood pressure, creatinine concentration and / or changes therein, other physiological indicators and / or symptoms related to heart failure, and / or other physiological parameters.

[0087] The system 300 may reset (processing portion 302) a low urine rate timer and / or a quantity or indicator of a urinary deficit ("deficiency") and / or update (processing portion 304) any measurements and / or calculations for the system 300 (e.g., after an amount of estimated excess fluid is entered in processing portion 301). As previously recited, the deficit may correspond to an area on a plot between the urination rate and a set rate, and may represent how much and for how long the urination rate is below the set rate. Updating the measurements / calculations may include obtaining the patient's urination rate, diuretic administration rate, rehydration fluid rate, and / or other data as described herein. The system 300 may determine (processing portion 306) whether at least a portion of the patient's therapy is scheduled to be stopped. If the system is scheduled to be stopped ("yes" in processing portion 306), the system 300 may stop the patient's therapy at the scheduled time (processing portion 312). At the scheduled time ("yes" at processing portion 312), system 300 may terminate the continuous infusion phase and / or stop delivery of diuretic to the patient. Additionally or alternatively, the user may provide an input to system 300 to terminate the continuous infusion phase and / or stop delivery of diuretic to the patient. If it is not the scheduled time ("no" at processing portion 312), system 300 may wait a predetermined period of time (e.g., at least 1 minute, 2 minutes, 10 minutes, 15 minutes, etc.) (processing portion 324) and then update any measurements and / or calculations (processing portion 304).

[0088] If the patient's therapy is not scheduled to be stopped ("no" at process portion 306), the system 300 can determine (process portion 308) whether the therapy period is greater than or equal to the low urination test time. The low urination test time can be at least 5 minutes, 10 minutes, 15 minutes, 20 minutes, 30 minutes, 1 hour, or another suitable time. If the treatment period is less than the low urination test time ("no" at processing portion 308), system 300 may compare the time since the reset of the low urine rate timer (e.g., processing portion 302 and / or 340) to a predetermined urine rate test time (e.g., processing portion 316, described in more detail below), and if the treatment period is greater than or equal to the low urination test time ("yes" at processing portion 308), system 300 may determine (processing portion 310) whether urination over the immediately preceding treatment period (e.g., the treatment period prior to the treatment period at processing portion 308) was greater than or equal to the low urination threshold, for example, before comparing the time since the reset of the low urine rate timer to the predetermined urine rate test time (processing portion 316). The low urination threshold may be at least 5 mL, 10 mL, 20 mL, 30 mL, 40 mL, 50 mL, or another suitable urination. If urination during the previous treatment period is less than the low urination threshold (e.g., if urination over the previous 15 minutes of treatment is less than 20 mL), the system 300 may provide a warning (processing portion 314) (e.g., to the user and / or via a status menu or display in the system 100).

[0089] Regardless of whether the urination of the immediately preceding treatment period is less than, more than, or equal to the low urination threshold, the system 300 can compare the time since the reset of the low urine rate timer to a predetermined urine rate test time (processing portion 316). The low urine rate timer can be automatically reset (processing portions 302 and / or 340) or reset by a user. The predetermined urine rate test time can be at least 5 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 6 hours, 12 hours, any amount of time between these amounts of time, or another suitable amount of time. If the time since the reset of the low urine rate time is less than the predetermined urine rate test time ("no" in processing portion 316), the system 300 can determine (processing portion 322) whether the patient meets one or more high urination criteria. The high voiding criteria were: voiding rate stop threshold (e.g., greater than 700 mL / hr, 800 mL / hr, 900 mL / hr, 1000 mL / hr, 1025 mL / hr, 1050 mL / hr, 1100 mL / hr, etc., in the past 3 hours or another period); voiding rate slope threshold (e.g., greater than 5 mL / hr in the past 2 hours or another period); 2 , 10mL / hr 2 , 20mL / hr 2 , 30mL / hr 2 , 40mL / hr 2 , 50mL / hr 2 , 60mL / hr 2 , 70mL / hr 2The high micturition criteria may include a threshold value (e.g., greater than 5 mg / hr, 10 mg / hr, 15 mg / hr, 20 mg / hr, 30 mg / hr, 40 mg / hr, 50 mg / hr, etc.), and / or a diuretic infusion rate threshold (e.g., greater than 5 mg / hr, 10 mg / hr, 15 mg / hr, 20 mg / hr, 30 mg / hr, 40 mg / hr, 50 mg / hr, etc.). If the patient does not meet one or more of the high micturition criteria ("no" at processing portion 322), system 300 may wait a predetermined period of time (processing portion 324), update any of the measurements and / or calculations (processing portion 304), and / or repeat one or more of the processing portions described herein. If the patient meets one or more of the high urination criteria ("Yes" in processing portion 322), the system 300 may set the patient's diuretic infusion rate to a percentage of the continuous infusion rate value (e.g., 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, or up to 99%) (processing portion 330), terminate the continuous infusion, and proceed to a downward titration phase or other processing as described herein above (e.g., with reference to FIG. 2).

[0090] The system 300 can determine the patient's urination rate, e.g., average urination rate over a predetermined time period (e.g., 3 hours) (processing portion 318) if the time since the reset of the low urine rate time is greater than or equal to a predetermined urine rate test time ("yes" in processing portion 316), and can determine whether the diuretic infusion rate is lower than a predetermined threshold ("predetermined urination rate threshold") (e.g., at least 50 mL / hr, 100 mL / hr, 200 mL / hr, 300 mL / hr, 325 mL / hr, 400 mL / hr, etc.) (processing portion 326) if the urination rate falls below a predetermined threshold ("predetermined diuretic rate threshold") (e.g., at least 10 mg / hr, 20 mg / hr, 30 mg / hr, 40 mg / hr, etc.) (processing portion 326). If the first diuretic (e.g., Lasix) is being infused at less than a predetermined rate or maximum rate ("predetermined diuretic rate") (e.g., 30 mg / hr) ("yes" in processing portion 326), system 300 may recommend resuming ramping (e.g., initiating re-ramping) for the patient (processing portion 332) and may wait for a predetermined period of time before repeating one or more processing portions of system 300 (processing portion 324). In some embodiments, resuming ramping for the patient (processing portion 332) may include resuming dose finding by, for example, setting the diuretic administration rate to a ramp corresponding to the continuous diuretic infusion rate, and exiting the continuous infusion phase and proceeding to the dose finding phase. Dose finding may be resumed / restarted in response to input from a user.

[0091] If the first diuretic is being infused at or above the predetermined diuretic rate ("No" in processing portion 326), the system 300 can determine (processing portion 334) what percentage of the current estimated excess fluid volume has actually been removed. If (i) a greater than a predetermined percentage (e.g., 60%, 70%, 80%, or 90%) of the estimated excess fluid volume has been removed (e.g., the actual percentage net fluid loss is greater than the predetermined percentage), or (ii) a volume less than a predetermined volume ("predetermined fluid threshold") (e.g., 0.5 L, 0.8 L, 0.9 L, 1 L, 1.1 L, 1.2 L, or 1.5 L) is predicted to remain in the patient (e.g., the amount of estimated excess fluid remaining or removed is greater than the predetermined fluid threshold) ("yes" in processing portion 334), system 300 may generate a warning (processing portion 342) indicating that therapy will be stopped within a predetermined time (e.g., 1 hour) unless action is taken in advance by the user, wait a predetermined period of time (processing portion 324), and / or repeat one or more steps of system 300. At this point, the user can (i) manually stop the therapy, (ii) decide whether to increase the amount of estimated excess fluid, or (iii) extend the therapy for a period of time (e.g., a predetermined urination rate test time). In some embodiments, the therapy can be extended, for example, if the user believes that the urination measured by the system is incorrect. If the user increases the amount of estimated excess fluid or extends the therapy, timers are reset to determine whether (i) the diuretic has been infused at or above a predetermined rate for a predetermined time, and / or (ii) the urination rate has exceeded a predetermined urination threshold for a predetermined urination rate time.

[0092] If the percentage of the estimated excess fluid amount removed is less than a predetermined percentage (e.g., less than 80%) and a greater than predetermined fluid volume remains (e.g., greater than 1 L) ("no" at process portion 334), system 300 may attempt to improve the patient's urine production in a safe and efficient manner (e.g., as described herein with reference to FIG. 3C). For example, system 300 may determine (process portion 336) whether the estimated excess fluid amount has been updated within a predetermined time (e.g., 24 hours, 30 hours). If the estimated excess fluid amount has not been updated within the predetermined time ("no" at process portion 336), a warning may be generated (process portion 338) indicating that additional input needs to be provided by the user and that the patient is urinating less. System 300 may continue by resetting the low urine rate timer and the urine deficit (process portion 340) and repeating one or more process portions of system 300. If the amount of estimated excess fluid is updated within a predetermined time ("Yes" in processing portion 336), a warning may be generated indicating that the patient is urinating low (processing portion 344), and system 300 may provide one or more outputs including recommendations regarding regulating the patient's urination and / or take one or more actions configured to regulate the patient's urination (processing portion 346, described in more detail with reference to FIG. 3C), reset the low urine rate timer and urinary deficit (processing portion 340), and repeat one or more processing portions of system 300.

[0093] If the urination rate is at or above a predetermined urination rate threshold (e.g., 325 mL / hour) ("no" case in processing portion 318), system 300 can determine (processing portion 320) whether the patient's urination deficit is greater than a predetermined threshold ("urination deficit threshold") (e.g., 150 mL), e.g., whether the patient's urination deficit over a predetermined time period (e.g., 3 hours) is less than the urination deficit threshold. If the patient's urination deficit is less than or equal to the urination deficit threshold ("no" case in processing portion 320), system 300 can determine (processing portion 322) whether the patient meets one or more high urination criteria as described herein above. If the patient's urinary deficit is greater than the urinary deficit threshold ("yes" at process portion 320), system 300 may determine whether the diuretic infusion rate is less than a predetermined diuretic rate (process portion 328), which may be at least substantially similar to or identical to process portion 326 described herein above. If the diuretic infusion rate is less than the predetermined diuretic rate ("yes" at process portion 328), system 300 may recommend resuming ramping (e.g., initiating re-ramping) for the patient (process portion 332) and wait a predetermined period of time before repeating one or more process portions of system 300 (process portion 324). If the diuretic infusion rate is equal to or greater than the predetermined diuretic rate ("no" at process portion 328), system 300 may wait a predetermined period of time before repeating one or more process portions of system 300 (process portion 324).

[0094] 3C is a flow diagram of one or more actions (e.g., performed by system 300) configured to regulate a patient's urination (processing portion 346) in accordance with an embodiment of the present technology. System 300 can determine (processing portion 350) whether a second diuretic (e.g., a thiazide) is currently being administered to the patient in addition to the first diuretic. If the second diuretic is not being administered ("no" at processing portion 350), system 300 can recommend administration, for example, through software or labeling (processing portion 354). If the user consents to administering the second diuretic ("Yes" in processing portion 354), system 300 may administer both diuretics by administering the second diuretic at a second diuretic infusion rate (processing portion 360), clear the low urination alert (processing portion 364), and continue therapy (e.g., automatically and / or in response to user input) by returning to other processing portions of system 300 (e.g., processing portion 340). In some embodiments, system 300 may automatically administer the second diuretic (processing portion 360). Although described as a second diuretic, one skilled in the art will appreciate that processing portion 360 may additionally or alternatively include administering one or more other drugs, medications, and / or compounds to the patient. In at least some embodiments, for example, processing portion 360 includes steps of administering a third diuretic (e.g., different from the first diuretic and / or the second diuretic) at a third administration rate, administering a "nephron bomb" (e.g., loop diuretics, metolazone, spironolactone, acetazolamide, amiloride, and SGLT2i), performing ultrafiltration, performing continuous venovenous hemodialysis (CVVH), and / or performing another appropriate therapeutic intervention.Alternatively, the user may be encouraged to stop treatment and / or therapy may be automatically stopped or may be automatically stopped after a predetermined period of time if the user does not consent to administering a second diuretic ("no" in processing portion 354), for example, because the patient has met other predetermined stopping criteria (e.g., low blood pressure, significant changes in electrolyte or creatinine concentrations, etc.) ("yes" in processing portion 356).

[0095] If the patient is already administered a second diuretic ("yes" in processing portion 350), the system 300 can determine (processing portion 352) whether the patient is on an increased fluid match. If the patient is not on an increased fluid match ("no" in processing portion 352), the system 300 can recommend (processing portion 358) increasing (e.g., temporarily increasing) the infusion of rehydration fluid (e.g., saline) to match a higher percentage of the urination rate (e.g., at least 80%, 90%, or 100%). If the user agrees to the increased rehydration fluid match ("yes" in processing portion 358), the system 300 can continue the therapy with the increased rehydration fluid match (processing portion 362), clear the low urination warning (processing portion 364), and return to the system 300 (e.g., processing portion 340). In some embodiments, the system 300 can automatically continue the therapy with the increased rehydration fluid match (processing portion 362). In these and other embodiments, the increasing hydration fluid match can continue (i) until a predetermined volume (e.g., 500 mL) is met, (ii) until a predetermined amount of time (e.g., 6 hours) has elapsed, or (iii) until the urination measurement is greater than a predetermined threshold (e.g., 525 mL / hour). Additionally or alternatively, the increasing hydration fluid match (processing portion 362) can include one increase or multiple increases. For example, if the patient's urination rate remains low after an initial increase in hydration fluid match (e.g., from 70% to 80%), the system 300 can trigger a second increase in hydration fluid match (e.g., from 80% to 90%). If the user does not agree to the augmented hydration fluid match (processing portion 358, "no"), system 300 can recommend stopping therapy, for example, when the patient meets one or more stopping criteria (processing portion 356, "yes") or if the user feels that low urination is incorrect, or can clear the warning and continue the current therapy (processing portion 358, "no", processing portion 356, "no", and processing portion 364).

[0096] Although in FIG. 3C system 300 is shown as determining whether the patient is on increased fluid matching (processing portion 352) after determining whether the patient is on a second diuretic (processing portion 350), in other embodiments the order of these processing portions can be reversed. For example, system 300 can determine whether the patient is on increased fluid matching (processing portion 352) before determining whether the patient is on a second diuretic (processing portion 350) and attempt to provide increased fluid matching before administering the second diuretic. Additionally or alternatively system 300 can be configured to administer the second diuretic (processing portion 360) and simultaneously and / or independently increase fluid matching (processing portion 362). That is, processing portion 360 can be independent of whether processing portion 362 has altered or had any effect on the patient's urination, or vice versa. Alternatively, processing portion 360 may be executed with some time delay (e.g., at least 1 minute, 5 minutes, 10 minutes, 30 minutes, 1 hour, 2 hours, 3 hours) after executing processing portion 362, or vice versa. For example, system 300 may enhance fluid matching (processing portion 362) and then administer a second diuretic (processing portion 360) 5 minutes later, e.g., without making a decision based on the patient's urination and / or diuretic administration rate.

[0097] 3A-3C, embodiments of the present technology can advantageously manage a patient's urination by ceasing fluid therapy in the event of sufficient fluid loss and increasing urination in the event of insufficient fluid loss. Furthermore, in the event of insufficient fluid loss, the system can recommend actions to increase urination that take into account (i) the amount of estimated excess fluid entered by the user, (ii) the percentage of actual net fluid loss relative to the amount of estimated excess fluid, and (iii) the estimated fluid remaining in the patient, thereby safely and substantially improving fluid therapy.

[0098] 4 is a flow diagram of a method 400 of providing fluid therapy to a patient. At least some aspects of the method 400 may be substantially similar or identical to one or more aspects of the method 200 and / or may be performed by one or both of the systems 100, 300 described herein. The method 400 may include accepting an estimated amount of excess fluid for the patient (processing portion 402) so that a target can be set for fluid removal during the therapy as described above. The estimated amount of excess fluid may be determined automatically (e.g., based on the patient's demographic information, therapy treatment history, current therapy treatment, etc.) and / or may be provided by a user (e.g., a doctor, clinician, nurse, etc.) and may correspond to the amount described with reference to processing portion 301 (FIG. 3A).

[0099] The method 400 can include repeatedly acquiring the patient's urination rate (processing portion 404), e.g., every second, every 5 seconds, every 30 seconds, every minute, every 5 minutes, every 30 minutes, every hour, etc. This processing portion can be at least substantially similar or identical to the processing portion 304 of the system 300. The patient's urination rate can be acquired using the controller 140 and / or the urinary system 110 of the system 100 of FIG. 1A. In some embodiments, other inputs can be acquired and used in addition to or instead of the urination rate. Such inputs can include urine analytes (type, concentration, concentration change, etc.), blood pressure, creatinine (e.g., concentration, concentration change, etc.), impedance measurements, clearance rate of tracer, and / or other physiological symptoms related to heart failure.

[0100] Method 400 can include repeatedly obtaining a patient's diuretic dosing rate every second, every 5 seconds, every 30 seconds, every minute, every 5 minutes, every 30 minutes, and every hour (processing portion 4). This processing portion can be at least substantially similar to or identical to processing portion 304 of system 300. The patient's diuretic dosing rate can be obtained using controller 140 and / or diuretic system 130 of system 100 of FIG. 1A. In some embodiments, the diuretic dosing rate can be relatively constant, such as during a continuous delivery or infusion phase.

[0101] The method 400 may include repeatedly obtaining (processing portion 408) (i) a first input corresponding to a percentage of actual net fluid loss relative to an estimated amount of excess fluid, and / or (ii) a second input corresponding to an estimated amount of fluid remaining, every 1 second, 5 seconds, 30 seconds, 1 minute, 5 minutes, 30 minutes, and 1 hour. This processing portion may be at least substantially similar or identical to processing portion 304 of system 300. The first input and / or second input may be obtained using controller 140 and / or diuretic system 130 of system 100 of FIG. 1A. For example, the first input may be obtained by dividing the actual amount of net fluid loss by the estimated amount of excess fluid, and the second input may be determined based on the difference between the amount of fluid removed and the amount of estimated excess fluid.

[0102] Method 400 may include providing an output associated with adjusting fluid therapy based on the first input and / or the second input (processing portion 410). In at least some embodiments, providing the output includes providing an indication having recommendations or instructions to a user, for example, via a display (e.g., display 150 of FIG. 1A). The recommendations or instructions may be to use a different and / or additional diuretic for the patient and / or to increase rehydration fluid infusion for the patient.

[0103] In some embodiments, providing the output may include triggering one or more actions configured to change the urination rate based at least in part on, for example, the urination rate, the diuretic administration rate, the actual amount of net fluid loss, and / or the estimated remaining fluid volume. For example, the output may be configured to increase the urination rate if the first input falls below a predetermined percentage threshold, if the second input is higher than a predetermined fluid threshold, or if both of these conditions are met. The processing portion 410 may be at least substantially similar or identical to the processing portions 334 and / or 346 of the system 300. Thus, the predetermined percentage threshold may be at least 60%, 70%, 80%, or 90% of the current amount of estimated excess fluid, and the predetermined fluid threshold may be 0.5L, 0.8L, 0.9L, 1L, 1.1L, 1.2L, or 1.5L. When the percentage of the actual amount of net fluid loss relative to the first input or estimated amount of excess fluid is lower than a predetermined percentage threshold and the second input or estimated remaining fluid is higher than a predetermined fluid threshold, the action configured to change the urination rate can include (i) recommending injecting a second diuretic to the patient and / or automatically injecting a second diuretic, and / or (ii) recommending increasing fluid matching and / or automatically injecting additional fluid to the patient. The step of administering the second diuretic can be at least substantially similar to or identical to the processing portion 334, 354, and / or 360 of the system 300. This processing portion can be at least substantially similar to or identical to the processing portion 358 and / or 362 of the system 300. In some embodiments, the step of recommending injecting the second diuretic can occur before the step of recommending increased fluid matching, if appropriate. Alternatively, the step of recommending injecting the second diuretic can occur after the step of recommending increased fluid matching, if appropriate.

[0104] In some embodiments, providing an output (processing portion 410), such as when the first input is at or above a predetermined percentage threshold and / or when the second input is below a predetermined fluid threshold, can include recommending stopping the patient's therapy, scheduling a time when the patient's therapy will be stopped, and / or automatically stopping the patient's therapy. This processing portion can be at least substantially similar to or identical to processing portions 334 and / or 342 of system 300. Additionally or alternatively, the output can include one or more warnings or notifications presented to the user, such as a warning that the patient is low in urine output (processing portion 344), a warning that therapy will be automatically stopped (processing portion 342), and / or a warning requesting user input (processing portion 338), such as when the estimated excess fluid has not been updated at a predetermined update time ("no" in processing portion 336).

[0105] 5 is a flow diagram of a method 500 of providing fluid therapy to a patient. At least some aspects of method 500 may be substantially similar or identical to one or more aspects of one or both of methods 200, 400 and / or may be performed by one or both of systems 100, 300 described herein. For example, method 500 may include processing portions 402, 404, 406, and / or 408 of method 400.

[0106] The method 500 may include determining whether (i) the urination rate over a first time period is lower than a predetermined urination threshold, and / or (ii) the diuretic administration rate over a second time period is equal to or higher than a predetermined diuretic threshold. The determining whether the urination rate over a first time period is lower than a predetermined urination threshold may be at least substantially similar or identical to the processing portion 318 of the system 300. For example, the predetermined urination threshold may be at least 50 mL / hr, 100 mL / hr, 200 mL / hr, 300 mL / hr, 325 mL / hr, 400 mL / hr, and / or the first time period may be the past 1 hour, 2 hours, or 3 hours. The determining whether the diuretic administration rate over a second time period is equal to or higher than a predetermined diuretic threshold may be at least substantially similar or identical to the processing portion 326 of the system 300. For example, the predetermined diuretic threshold may be at least 10 mg / hr, 20 mg / hr, 30 mg / hr, 40 mg / hr, and / or the second period of time may be the past 1 hour, 2 hours, or 3 hours.

[0107] The method 500 may include providing an output associated with adjusting fluid therapy based on the first input and / or the second input after determining whether the urination rate is below a predetermined urination threshold and / or whether the diuretic administration rate is equal to or above a predetermined diuretic threshold (processing portion 507). Providing the output may be at least substantially similar or identical to the processing portion 410 of the system 400. For example, providing the output may include adjusting the patient's urination (processing portion 346), providing one or more warnings (processing portions 344, 338), and / or providing an output related to stopping the patient's therapy (processing portion 342). In some embodiments, providing the output occurs only if and / or when the urination rate is below the predetermined urination threshold and the diuretic administration rate is at or above the predetermined diuretic threshold. In such embodiments, no output may be provided if the urination rate is not below a predetermined urination threshold or if the diuretic administration rate is not equal to or above a predetermined diuretic threshold.

[0108] As outlined in methods 400 and 500 and elsewhere herein, embodiments of the technology of the present invention can determine whether a patient is experiencing insufficient fluid loss and make recommendations and / or take actions to improve fluid therapy. Prior to making such recommendations and / or actions, aspects of the patient's current and past therapy are considered to ensure that any recommendations and / or actions are safe and justified. For example, as described herein, such considerations can include the patient's (i) average urination rate relative to a predetermined voiding threshold, (ii) average diuretic administration rate relative to a predetermined diuretic threshold, (iii) actual net fluid loss as a percentage of the estimated amount of excess fluid, and / or (iv) estimated remaining fluid volume. Advantageously, embodiments of the technology of the present invention can provide fluid therapy while also considering other safety concerns, such as the risk of hypotension to the patient. As discussed above, the risk of hypotension can be directly correlated to therapeutic efficacy and therefore must be considered when therapy adjustments are made or recommended. By taking into account the above conditions (i)-(iv), or more specifically, by recommending certain actions (e.g., administering additional diuretic and / or increasing rehydration fluid infusion rates) only after certain of conditions (i)-(iv) are satisfied, embodiments of the present technology can balance safety (e.g., risk of hypotension) and efficacy throughout treatment, thereby providing a more optimal fluid therapy for the patient.

[0109] III. Conclusion The technology of the present invention is exemplified according to various aspects, for example, as described below. Various examples of aspects of the technology of the present invention are described as numbered examples (1, 2, 3, etc.) for convenience. These examples are provided by way of example and not by way of limitation of the technology of the present invention. It should be noted that any of the dependent examples can be combined in any combination and incorporated into each independent example. Other examples can be presented in a similar manner.

[0110] example. 1. A method of providing fluid therapy comprising: receiving an estimate of fluid excess for a patient; repeatedly obtaining a urination rate for the patient; repeatedly obtaining a diuretic administration rate for the patient; determining whether (i) the urination rate over a first time period is below a predetermined urination threshold and / or (ii) the diuretic administration rate over a second time period is above a predetermined diuretic threshold; repeatedly obtaining (i) a first input corresponding to a percentage of an actual amount of net fluid loss relative to the estimate of fluid excess and / or (ii) a second input corresponding to an estimate of fluid remaining; and providing an output associated with adjusting fluid therapy based on the first input and / or the second input after determining whether the urination rate is below a predetermined urination threshold and / or whether the diuretic administration rate is at or above the predetermined diuretic threshold. 2. The method of Example 1, wherein providing an output includes providing a display having instructions to use a different diuretic and / or instructions to increase the amount of rehydration fluid provided to the patient. 3. The method of Example 1 or Example 2, wherein the diuretic administration rate is for a first diuretic and providing an output includes providing a display having instructions to provide a second diuretic to the patient. 4. The method of Example 3, wherein the first diuretic comprises bumetanide, ethacrynic acid, furosemide, and / or torsemide, and the second diuretic is different from the first diuretic and comprises bumetanide, ethacrynic acid, furosemide, torsemide, a thiazide-type diuretic, chlorothiazide, metolazone, amiloride, or spironolactone. 5. The method of any one of Examples 1-4, further comprising providing hydration fluid to the patient at a first rate, and wherein providing an output comprises recommending providing hydration fluid to the patient at a second rate that is higher than the first rate. 6. Any of the methods of Examples 1-5, wherein when the first input is higher than a predetermined percentage threshold or when the second input is lower than a predetermined fluid threshold, providing an output includes providing an indication having instructions to reduce a diuretic administration rate and / or a rehydration fluid infusion rate. 7. The method of any of Examples 1-6, wherein the first period of time is at least 1 hour and the predetermined voiding threshold is at least 325 milliliters per hour. 8. The method of any of Examples 1-7, wherein the second period of time is at least 1 hour and the predetermined diuretic threshold is at least 30 milligrams / hour. 9. The method of any of Examples 1-8, wherein providing an output occurs only if the first input is below a first threshold and the second input is above a second threshold. 10. A fluid therapy system including a urine measuring device configured to repeatedly measure urine output from a patient at predetermined intervals; a pump configured to provide a diuretic to the patient at a diuretic dosing rate; one or more processors; and a tangible, non-transitory computer readable medium having instructions that, when executed by the one or more processors, cause the fluid therapy system to perform operations including receiving an estimate of excess fluid for the patient, obtaining a urine output rate for the patient, obtaining a diuretic dosing rate for the patient, obtaining (i) a first input corresponding to a percentage of an actual amount of net fluid loss relative to the estimated amount of excess fluid, and / or (ii) a second input corresponding to an estimated amount of fluid remaining, and providing an output associated with adjusting fluid therapy based on the first input and / or the second input. 11. The system of example 10, wherein providing an output includes providing instructions to use a different diuretic and / or instructions to increase the amount of rehydration fluid provided to the patient. 12. The system of Example 10 or Example 11, wherein the diuretic is a first diuretic, and the system further includes a second pump configured to provide a second diuretic different from the first diuretic, and wherein providing an output includes providing instructions to infuse the second diuretic into the patient through the second pump. 13. The system of any of Examples 10-12, wherein the pump is a first pump, and the system further includes a second pump configured to infuse rehydration fluid to the patient at a first rate, and providing an output includes providing instructions to infuse the rehydration fluid to the patient at a second rate that is higher than the first rate. 14. The system of any of Examples 10-13, wherein providing an output includes providing instructions to reduce a diuretic administration rate and / or a rehydration fluid infusion rate when the first input is higher than a predetermined percentage threshold or when the second input is lower than a predetermined fluid threshold. 15. The system of any of Examples 10-14, further comprising the step of determining that the urination rate over a period of time is lower than a predetermined urination threshold, and wherein the step of providing an output occurs after determining that the urination rate is lower than the predetermined urination threshold. 16. The system of example 15, wherein the predetermined voiding threshold is at least 325 milliliters per hour. 17. The system of any of Examples 10-16, further comprising the step of determining that the diuretic administration rate over a period of time is equal to or greater than a predetermined diuretic threshold, and wherein the step of providing an output occurs after determining that the urination rate is less than the predetermined urination threshold. 18. The system of example 17, wherein the predetermined diuretic threshold is at least 30 milligrams / hour. 19. A tangible, non-transitory computer readable medium having instructions that, when executed by one or more processors, cause a fluid therapy system to perform operations including receiving an estimate of excess fluid for a patient; determining whether the patient's urination rate over a first time period is below a predetermined urination threshold; determining whether the patient's diuretic administration rate over a second time period is equal to or above the predetermined diuretic threshold; and providing an output associated with adjusting fluid therapy to the patient when the urination rate is at or below the predetermined urination threshold and the diuretic administration rate is at or above the predetermined diuretic threshold, the output including: (i) instructions to administer additional diuretic to the patient; and / or (ii) instructions to increase infusion of rehydration fluid to the patient. 20. The computer-readable medium of example 19, wherein the operation further includes obtaining an input corresponding to a percentage of an actual amount of net fluid loss relative to an estimated amount of excess fluid, and wherein providing an output is further based on the input. 21. The computer-readable medium of example 19 or example 20, wherein the operation further includes obtaining an input corresponding to an estimated amount of fluid remaining in the patient, and wherein providing an output is further based on the input. 22. The computer-readable medium of any of Examples 19-21, wherein the operation further includes obtaining (i) a first input corresponding to a percentage of the actual amount of net fluid loss relative to the estimated amount of excess fluid, and / or (ii) a second input corresponding to the estimated amount of fluid remaining, and wherein providing an output is further based on the first input and the second input. 23. The computer-readable medium of example 22, wherein providing an output occurs only if the first input is lower than a first threshold and the second input is higher than a second threshold. 24. The computer readable medium of Example 22 or Example 23, wherein the output is a first output and the computer readable medium further comprises providing a second output including instructions for reducing a diuretic administration rate and / or a rehydration fluid infusion rate when the first input is above a predetermined percentage threshold and / or the second input is below a predetermined fluid threshold. 25. The computer-readable medium of any of Examples 19-24, wherein the first period of time is at least one hour and the predetermined voiding threshold is at least 325 milliliters per hour. 26. The computer-readable medium of any of Examples 19-25, wherein the second period of time is at least 1 hour and the predetermined diuretic threshold is at least 30 milligrams / hour. 27. A method for providing fluid therapy comprising: accepting an estimated amount of excess fluid for a patient; repeatedly obtaining a urination rate for the patient; repeatedly obtaining a diuretic administration rate for the patient; repeatedly obtaining a percentage of an actual amount of net fluid loss relative to the estimated amount of excess fluid; and causing an action configured to alter the urination rate, the diuretic administration rate, and at least one of (i) a percentage relative to a predetermined percentage threshold or (ii) an estimated remaining amount of fluid relative to a predetermined fluid threshold. 28. The method of Example 27, wherein the step of repeatedly acquiring the patient's urination rate includes repeatedly acquiring the patient's urination rate at a first predetermined interval, and / or the step of repeatedly acquiring the patient's diuretic administration rate includes repeatedly acquiring the patient's diuretic administration rate at a second predetermined interval. 29. The method of example 28, wherein the first predetermined interval and the second predetermined interval are the same predetermined interval. 30. The method of any of Examples 27-29, wherein the diuretic administration rate is for infusing a first diuretic into the patient and the action includes causing a second diuretic to be infused into the patient when the percentage is lower than a predetermined percentage threshold and the estimated remaining excess fluid volume is higher than a predetermined fluid threshold. 31. The method of example 30, wherein the first diuretic comprises bumetanide, ethacrynic acid, furosemide, torsemide, or a thiazide, and the second diuretic is different from the first diuretic. 32. The method of any of Examples 27-31, further comprising infusing rehydration fluid into the patient at a first rate, and when the percentage is below a predetermined percentage threshold and the estimated remaining excess fluid volume is above a predetermined fluid threshold, an action includes causing the rehydration fluid to be infused at a second rate greater than the first rate. 33. The method of any of Examples 27-32, wherein the percentage is lower than a predetermined percentage threshold, the estimated remaining fluid volume is greater than a predetermined fluid threshold, the diuretic administration rate is for infusing a first diuretic into the patient, and the action includes causing (i) a second diuretic to be infused into the patient, and (ii) an infusion of rehydration fluid to the patient to be increased. 34. The method of any of Examples 27-33, including a step in which an action causes delivery of at least one of a diuretic or rehydration fluid to the patient to be stopped when the percentage is higher than a predetermined percentage threshold or when the estimated remaining fluid volume is lower than a predetermined fluid threshold. 35. The method of any of Examples 27-34, wherein the step of triggering an action is further based on the urination rate being below a predetermined urination threshold. 36. The method of Example 35, wherein comparing the urination rate to a predetermined urination threshold comprises comparing an average urination rate over a predetermined urination rate test time to the predetermined urination threshold. 37. The method of Example 36, wherein the predetermined urine rate testing time is at least 1 hour and the predetermined voiding threshold is at least 325 milliliters / hour. 38. The method of any of Examples 27-37, wherein the step of causing an action is further based on the diuretic administration rate being at or greater than a predetermined diuretic administration rate. 39. The method of Example 38, wherein the step of comparing the diuretic administration rate to a predetermined diuretic rate comprises comparing the diuretic administration rate to the predetermined diuretic administration rate over a predetermined urine rate test time. 40. The method of example 39, wherein the step of causing an action includes the step of causing an action when the diuretic administration rate is at or above a predetermined diuretic administration rate for a predetermined urine rate test time. 41. The method of example 39 or example 40, wherein the predetermined urine rate test time is at least 1 hour and the predetermined diuretic administration rate is at least 30 milligrams / hour. 42. Any of the methods of Examples 27-41, further comprising setting a delivery stop time for at least one of the diuretic or rehydration fluid when (i) the percentage of the actual amount of net fluid loss relative to the target net fluid loss falls below a predetermined percentage, and / or (ii) the estimated amount of fluid removed is below a predetermined fluid threshold. 43. A fluid therapy system including a urine measuring device configured to repeatedly measure urine output from a patient at predetermined intervals; a pump configured to provide a diuretic to the patient at a diuretic administration rate; one or more processors; and a tangible, non-transitory computer readable medium having instructions that, when executed by the one or more processors, cause the fluid therapy system to perform operations including accepting an estimated amount of excess fluid for the patient, obtaining a percentage of an actual amount of net fluid loss relative to the estimated amount of excess fluid, obtaining an estimated remaining fluid volume from the patient, and causing an action configured to alter a urine output rate based on at least one of (i) the percentage relative to a predetermined percentage threshold or (ii) the estimated remaining fluid volume relative to a predetermined fluid threshold. 44. The system of example 43, wherein the diuretic administration rate is for infusing a first diuretic into the patient and the step of causing an action includes the step of causing a second diuretic to be infused into the patient when the percentage is lower than a predetermined percentage threshold and the estimated remaining fluid volume is higher than a predetermined fluid threshold. 45. The system of example 43 or example 44, wherein operation further includes injecting rehydration fluid into the patient. 46. ​​The system of example 45, wherein rehydration fluid is infused into the patient at a first rate, and when the percentage is lower than a predetermined percentage threshold and the estimated remaining fluid volume is higher than a predetermined fluid threshold, the step of causing an action includes causing the rehydration fluid to be infused at a second rate higher than the first rate. 47. The system of any of Examples 43-46, wherein the percentage is lower than a predetermined percentage threshold, the estimated remaining fluid volume is greater than a predetermined fluid threshold, the diuretic is a first diuretic, and the step of causing an action includes the steps of: (i) infusing a second diuretic to the patient; and (ii) increasing the rate of infusion of rehydration fluid to the patient. 48. The system of any of Examples 43-47, wherein the step of causing an action includes a step of causing delivery of at least one of a diuretic or a rehydration fluid to the patient to be stopped when the percentage is higher than a predetermined percentage threshold or when the estimated remaining fluid volume is lower than a predetermined fluid threshold. 49. The system of any of Examples 43-48, wherein the step of triggering an action is further based on the urination rate being below a predetermined urination threshold. 50. The system of example 49, wherein operation further comprises comparing the average urination rate over a predetermined urination rate test time to a predetermined urination threshold. 51. The system of example 50, wherein the predetermined urine rate test time is at least 3 hours and the predetermined urination threshold is at least 325 milliliters / hour. 52. The system of any of Examples 43-51, wherein the step of triggering an action is further based on the diuretic administration rate being at or exceeding a predetermined diuretic administration rate. 53. The system of example 52, wherein operation further comprises comparing the diuretic administration rate to a predetermined diuretic administration rate over a predetermined urine rate test time. 54. The system of example 53, wherein the step of causing an action includes the step of causing an action when the diuretic administration rate is at or above a predetermined diuretic administration rate for a predetermined urine rate test time. 55. The system of example 53 or example 54, wherein the predetermined urine rate test time is 3 hours and the predetermined diuretic administration rate is at least 30 milligrams / hour. 56. A method of providing fluid therapy comprising: receiving a low urination indication for a patient, the receiving step including at least one of determining that a percentage of an actual amount of net fluid loss relative to an estimated amount of excess fluid has exceeded a predetermined percentage or determining that an estimated remaining excess fluid amount has exceeded a predetermined fluid threshold; and causing, based on the received low urination indication, an action to increase the patient's urination by administering a diuretic to the patient at a diuretic infusion rate and / or increasing the infusion of rehydration fluid into the patient. 57. The method of example 56, wherein the step of causing an action includes increasing a rate of rehydration fluid infusion to the patient. 58. The method of Example 56, further comprising administering to the patient a first diuretic, and wherein causing an action comprises administering to the patient a second diuretic. 59. The method of any of Examples 56-58, wherein the predetermined percentage is at least 80% and the predetermined fluid threshold is at least 1 liter. 60. The method of any of Examples 56-59, wherein administering the diuretic includes automatically administering the diuretic to the patient by a fluid therapy system. 61. The method of any of Examples 56-60, wherein increasing the infusion of rehydration fluid includes automatically increasing the infusion of rehydration fluid by the fluid therapy system. 62. A method of providing fluid therapy comprising receiving an estimated amount of excess fluid for a patient, obtaining a percentage of an actual amount of net fluid loss relative to the estimated amount of excess fluid, obtaining an estimate of the amount of excess fluid to be removed, and causing an action to be configured to alter the patient's urination rate based on at least one of (i) the percentage exceeding a predetermined percentage threshold or (ii) the estimated amount of fluid exceeding a predetermined fluid threshold.

[0111] It will be apparent to those skilled in the art that changes may be made to the details of the above-described embodiments without departing from the principles underlying the technology of the present invention. In some cases, known structures and functions have not been shown or described in detail to avoid unnecessarily obscuring the description of the embodiments of the technology of the present invention. Although method steps may be provided in a particular order herein, alternative embodiments may perform these steps in a different order. Similarly, certain aspects of the technology of the present invention that are disclosed in the context of certain embodiments may be combined or eliminated in other embodiments. Furthermore, while advantages associated with certain embodiments of the technology of the present invention may be disclosed in the context of these embodiments, other embodiments may also exhibit such advantages, and not all embodiments necessarily exhibit such advantages or other advantages disclosed herein to fall within the technology of the present invention. Thus, the disclosure of the present invention and related technologies may encompass other embodiments not expressly shown or described herein, and the present invention is not limited except as limited by the scope of the claims.

[0112] Unless the context clearly indicates otherwise throughout this disclosure, the singular forms "a," "an," and "the" include plural referents. Similarly, unless the term "or" is expressly limited in reference to a list of two or more items to mean only a single item without any other items, the use of "or" in such a list shall be interpreted to include (a) any single item in the list, (b) all of the items in the list, or (c) any combination of items in the list. In addition, the terms "comprising," "including," and "having" shall be interpreted to mean the inclusion of at least the recited features, and thus not the exclusion of any greater number of the same features and / or other features of additional types.

[0113] Reference herein to "one embodiment," "embodiments," "some embodiments," or similar statements means that a particular feature, structure, operation, or characteristic described in connection with the embodiment may be included in at least one embodiment of the present technology. Thus, the appearances of such phrases or statements herein are not necessarily all referring to the same embodiment. Furthermore, various particular features, structures, operations, or characteristics may be combined in any suitable manner in one or more embodiments.

[0114] Unless otherwise indicated, all numbers expressing concentration, shear strength, and other numerical values ​​used in the specification and claims should be understood to be modified in all instances by the term "about." Thus, unless indicated to the contrary, the numerical parameters set forth in the specification and claims are approximations that may vary depending on the desired properties sought to be obtained by the technology of the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed by applying ordinary rounding techniques in light of the number of significant digits disclosed. In addition, all ranges disclosed herein should be understood to include any and all subranges subsumed within that range. For example, a range of "1 to 10" includes any and all subranges between (and including) a minimum value of 1 and a maximum value of 10, and therefore any and all subranges having a minimum value equal to or greater than 1 and a maximum value equal to or less than 10, such as 5.5 to 10.

[0115] The disclosure of the invention set forth above should not be interpreted as reflecting an intention that any claim requires more features than are expressly recited in that claim. Instead, as the following claims reflect, inventive aspects lie in combinations of less than all features of any one of the foregoing disclosed embodiments. Accordingly, the claims following the Detailed Description are expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment. The disclosure of the invention includes all permutations of independent claims with their dependent claims. [Explanation of symbols]

[0116] 100 Fluid Management System 110 Urinary System 118 Catheter 120 Water Supply System 130 Diuretic System

Claims

1. A fluid therapy system comprising: a urine measurement device configured to repeatedly measure urine output from a patient at predetermined intervals; a pump configured to provide a diuretic to the patient at a diuretic administration rate; one or more processors; when executed by the one or more processors, receiving an estimate of excess fluid for the patient; obtaining the urine output rate of the patient; obtaining the diuretic administration rate of the patient; obtaining (i) a first input corresponding to a percentage of the actual amount of net fluid loss relative to the estimated amount of excess fluid, and / or (ii) a second input corresponding to the estimated amount of remaining fluid; and providing an output associated with adjusting the fluid therapy based on the first input and / or the second input; a tangible non-transitory computer-readable medium having instructions for causing the fluid therapy system to perform an operation including the above; a system including the above.

2. The system of claim 1, wherein the step of providing the output includes providing instructions for using a different diuretic and / or increasing the amount of rehydration fluid provided to the patient.

3. The diuretic is a first diuretic, and the system further includes a second pump configured to provide a second diuretic different from the first diuretic, wherein the step of providing the output includes providing instructions for injecting the second diuretic into the patient through the second pump. The system of claim 1.

4. The pump is a first pump, and the system further includes a second pump configured to inject rehydration fluid into the patient at a first rate, wherein the step of providing the output includes providing instructions for injecting the rehydration fluid into the patient at a second rate higher than the first rate. The system of claim 1.

5. The system of claim 1, wherein when the first input is higher than a predetermined percentage threshold or the second input is lower than a predetermined fluid threshold, the step of providing the output includes providing instructions for reducing the diuretic administration rate and / or the rehydration fluid injection rate.

6. further comprising determining that the urine output rate over a period is lower than a predetermined urine output threshold, wherein the step of providing the output occurs after determining that the urine output rate is lower than the predetermined urine output threshold. The system according to claim 1.

7. The system according to claim 6, wherein the predetermined urine output threshold is at least 325 milliliters per hour.

8. Further comprising determining that a diuretic administration rate over a period of time is equal to or higher than a predetermined diuretic threshold of at least 30 milligrams per hour, wherein the step of providing the output occurs after determining that the diuretic administration rate is equal to or higher than the predetermined diuretic threshold. The system according to claim 1.

9. When executed by one or more processors, receiving an estimate of excess fluid for a patient; determining whether a urine output rate of the patient over a first period is lower than a predetermined urine output threshold; determining whether a diuretic administration rate of the patient over a second period is equal to or higher than a predetermined diuretic threshold; providing an output associated with adjusting fluid therapy provided to the patient when the urine output rate is at or below the predetermined urine output threshold and the diuretic administration rate is at or above the predetermined diuretic threshold, the output including (i) an instruction to administer additional diuretics to the patient and / or (ii) an instruction to increase the infusion of rehydrating fluid to the patient; A tangible non-transitory computer-readable medium having instructions for causing a fluid therapy system to perform operations including the above.

10. The operations further include obtaining an input corresponding to a percentage of the actual amount of net fluid loss relative to the estimated amount of excess fluid, and the step of providing the output is further based on the input. The computer-readable medium according to claim 9.

11. The operations further include obtaining an input corresponding to an estimated amount of fluid remaining in the patient, and the step of providing the output is further based on the input. The computer-readable medium according to claim 9.

12. The operations further include obtaining (i) a first input corresponding to a percentage of the actual amount of net fluid loss relative to the estimated amount of excess fluid and / or (ii) a second input corresponding to an estimated amount of remaining fluid, and the step of providing the output is further based on the first input and the second input. The computer-readable medium according to claim 9.

13. The step of providing the output occurs only when the first input is lower than a first threshold value and the second input is higher than a second threshold value. The computer-readable medium according to claim 12.

14. The output is a first output, The computer-readable medium further includes a step of providing a second output including instructions for reducing the diuretic administration rate and / or the fluid infusion rate of the rehydration fluid when the first input is higher than a predetermined percentage threshold and / or the second input is lower than a predetermined fluid threshold. The computer-readable medium according to claim 12.

15. The first period is at least one hour, and the predetermined urine output threshold is at least 325 milliliters per hour. The computer-readable medium according to claim 9.

16. The second period is at least one hour, and the predetermined diuretic threshold is at least 30 milligrams per hour. The computer-readable medium according to claim 9.

17. A fluid therapy system, When executed by one or more processors, Obtaining the urine output rate of the patient, Obtaining the diuretic administration rate of the patient, Determining that (i) the urine output rate over a first period of at least one hour is lower than a predetermined urine output threshold and (ii) the diuretic administration rate over a second period of at least one hour is equal to or higher than a predetermined diuretic threshold of at least 5 milligrams per hour, and Providing an output associated with adjusting the fluid therapy provided to the patient based on the urine output rate being lower than the predetermined urine output threshold during the first period and the diuretic administration rate being equal to or higher than the predetermined diuretic threshold during the second period. Including a tangible non-transitory computer-readable medium having instructions for causing the fluid therapy system to perform an operation including The step of providing the output includes (i) adjusting the diuretic administration rate of the diuretic, (ii) injecting a rehydration fluid into the patient, and / or (iii) administering a different diuretic to the patient. A fluid therapy system.

18. Further including a pump configured to inject the rehydration fluid into the patient at a first rate, The step of providing the output includes injecting the rehydration fluid into the patient at a second rate that is higher than the first rate. The fluid therapy system according to claim 17. **Claim 19** The fluid therapy system according to claim 17, wherein the predetermined urine output threshold is at least 325 milliliters per hour. **Claim 20** The fluid therapy system according to claim 17, wherein the predetermined diuretic threshold is at least 30 milligrams per hour.

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