Urine collection systems and associated methods and device
The fluid management system addresses inefficiencies in conventional fluid overload treatment by using sensors and flow control to automate diuretic and rehydration fluid administration, ensuring continuous therapy and reducing hospitalization through precise urine monitoring and multiple container redundancy.
Patent Information
- Application Number
- JP2024191751
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2021-07-12
- Filing Date
- 2024-10-31
- Publication Date
- 2025-01-24
- Estimated Expiration
- Not applicable · inactive patent
AI Technical Summary
Conventional systems for managing fluid overload in patients, such as those with acute or chronic heart failure, lack accurate monitoring and control of urine production, leading to inefficient treatment and increased hospitalization times due to uncertainties in diuretic response, and require frequent manual intervention to prevent overflow.
A fluid management system with integrated sensors and flow control assemblies that monitor urine production and automatically adjust diuretic and rehydration fluid administration, using multiple containers and redundant sources to maintain continuous therapy without interruption.
The system enables precise monitoring and control of urine output, reducing treatment time, minimizing hospital stays, and improving patient safety by ensuring consistent fluid removal and electrolyte balance.
Smart Images

Figure 2025013414000001_ABST
Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is related to U.S. Patent Application No. 17 / 112,925, filed December 4, 2020, and claims priority to U.S. Provisional Patent Application No. 63 / 220,873, filed July 12, 2021, and U.S. Provisional Patent Application No. 63 / 175,380, filed April 15, 2021, the disclosures of each of which are incorporated by reference herein in their entirety.
[0002] The present disclosure relates generally to medical devices, and more particularly to systems and related methods and devices for urine collection. [Background technology]
[0003] The human physiological system naturally seeks to maintain a balance between fluid intake and fluid excretion. An imbalance between the rates of fluid intake and excretion 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 conditions in which insufficient fluid is excreted. Patients with fluid overload can suffer from shortness of breath (dyspnea), edema, hypertension, and other undesirable conditions.
[0004] To treat fluid overload, patients are typically administered diuretics that induce and / or increase urine production, thereby reducing the amount of fluid and sodium in the body. For safety reasons, e.g., to avoid placing undue stress on the patient's kidneys, urination rates can be carefully monitored and / or controlled. Different patients may respond differently to treatment, and thus the same diuretic type and / or dosage may result in significantly different urination rates. However, conventional systems and methods for treating fluid overload may not have the ability to accurately monitor a patient's urination and / or respond to changes in urination. In addition to this, conventional treatment systems and devices may not have the ability to accommodate high urine production rates, and thus may require a nurse or other medical personnel to empty and / or replace urine collection bags multiple times during a treatment procedure. Conventional systems and devices may also be susceptible to air locks and / or interruptions to urine flow. Summary of the Invention
[0005] The features, aspects, and advantages of the techniques of the present disclosure may be better understood in conjunction with the following drawings. [Brief description of the drawings]
[0006] [Figure 1A] 1 is a partial schematic diagram of a fluid management system in accordance with an embodiment of the present technology; [Figure 1B] 1 is a partial schematic diagram of a fluid management system in accordance with an embodiment of the present technology; [Figure 1C] 1 is a partial schematic diagram of a fluid management system in accordance with an embodiment of the present technology; [Figure 1D] 1 is a partial schematic diagram of a fluid management system 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. [Diagram 3] 1 is a schematic diagram of a urine collection system in accordance with an embodiment of the present technology; [Figure 4A]FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 4B] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 4C] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 4D] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 4E] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 4F] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 4G] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 4H] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 4I] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 4J] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Diagram 5] 1 is a flow diagram illustrating a method for collecting urine from a patient in accordance with an embodiment of the present technology. [Figure 6A] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 6B] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 6C] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 6D] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 6E] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 6F] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 6G]FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 6H] FIG. 1 shows a representation of a urine collection system in accordance with an embodiment of the present technology. [Figure 7] 1 illustrates an example urine cartridge of a urine collection system in accordance with an embodiment of the present technology. [Figure 8] 1 is a flow diagram of a method for collecting urine from a patient in accordance with an embodiment of the present technology. [Figure 9A] FIG. 13 illustrates an example of an air lock in a urine collection system in accordance with an embodiment of the present technology. [Figure 9B] FIG. 13 illustrates another example of an air lock in a urine collection system in accordance with an embodiment of the present technology. [Figure 10] 1 is a schematic diagram of a urine collection system including a pumping device in accordance with an embodiment of the present technology. [Figure 11] FIG. 1 is a perspective view of a priming valve in accordance with an embodiment of the present technology. [Figure 12] FIG. 1 shows an example of a schematic urine collection system in accordance with an embodiment of the present technology. [Figure 13] FIG. 1 shows an example of a schematic urine collection system in accordance with an embodiment of the present technology. [Figure 14A] FIG. 1 shows an example of a schematic urine collection system in accordance with an embodiment of the present technology. [Figure 14B] FIG. 1 shows an example of a schematic urine collection system in accordance with an embodiment of the present technology. [Figure 15A] FIG. 1 is a perspective view of a priming assembly in accordance with an embodiment of the present technology. [Figure 15B] 1 is a cross-sectional view of a priming assembly in accordance with an embodiment of the present technology. [Figure 15C] 15A and 15B are cross-sectional views of a portion of a priming assembly. [Figure 15D] 15A and 15B are cross-sectional views of a portion of a priming assembly.
[0007] Those skilled in the art will appreciate that the features shown in the drawings are for illustrative purposes only and that variations are possible, including different and / or additional features and arrangements thereof. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0008] The present technology relates to systems and related methods and devices for collecting and / or monitoring a patient's urine output. In some embodiments, a urine collection system includes a first container and a second container configured to hold urine from a patient. The system can further include at least one sensor configured to generate sensor data indicative of the amount of urine in the first and / or second containers. The system can further include a flow control assembly configured to direct a urine flow from the patient into the first container or the second container based on the sensor data. For example, the flow control assembly can include a set of valves and / or other fluid control elements for selectively directing the urine flow into the first container and / or the second container. If the flow control assembly detects that one of the containers is full or nearly full, it can automatically redirect the urine flow into the other container. This approach can be advantageous for medical procedures in which a patient produces large amounts of urine, such as procedures for treating a patient by administering a diuretic for fluid overload. For example, the present technology can reduce the number of times a user (e.g., a nurse or other medical personnel) is required to inspect and / or empty the containers. The technology of the present invention allows the user to easily remove and empty the urine container, thereby reducing the possibility of leakage or spillage.
[0009] In some embodiments, the fluid therapy system and / or urine collection system includes a container, a flow control assembly configured to direct urine flow from a patient to the container, and a urine measurement device or system including a first sensor and a second sensor. The first sensor is configured to generate first sensor data based on the weight of the container, and the second sensor is configured to generate second sensor data based on urine flow from the patient to the container. The first and second sensor data can be used to generate first and second patient urinations, respectively (e.g., average urine flow rate and / or urine volume over a period of time). The system can utilize each of the first and second patient urinations as a primary information source to determine the amount of diuretic and / or rehydration fluid to be provided to the patient. For example, in some embodiments, the first patient urination (e.g., based on the weight change of the container) is used as the primary information source unless the system detects that the weight of the container is decreasing, thereby potentially indicating that the container is being drained. When the system detects that the weight of the container is decreasing, the second patient urination (based on the flow of the container) can be used as the primary information source. As described herein, this approach allows for accurate and reliable determination of urination rate even when the container is being drained. Thus, embodiments of the present technology allow for continuous fluid therapy with limited risk of interruption. Additionally or alternatively, embodiments of the present technology may allow medical personnel (e.g., nursing assistants) who are permitted to interact with the container but not operate the medical device to drain the container without using the system's user interface.
[0010] The present technology further provides devices and associated methods suitable for use in combination with a urine collection system. In some embodiments, for example, a device for collecting urine from a patient includes a first fluid line configured to be coupled to the patient's body, a second fluid line configured to be coupled to a urine container, and a hollow member (e.g., a flexible valve) fluidly coupling the first and second fluid lines. The hollow member can have a first end portion coupled to the first fluid line, a second end portion coupled to the second fluid line, and a flexible body portion fluidly coupling the first and second end portions. Each of the first and second end portions can include a respective check valve that allows fluid flow from the patient's body to the urine container while preventing fluid flow in the opposite direction. In some embodiments, the flexible body portion is configured to be repeatedly actuated (e.g., compressed) to draw fluid from the patient's body into one or both of the first or second fluid lines. Actuation of the flexible body portion can prime the fluid line with fluid (e.g., saline and / or urine) and / or remove air from the fluid line (e.g., by displacing air into the urine container). Thus, the device can maintain a nearly continuous flow of urine from the patient's body to the urine container, which can be advantageous with respect to fluid removal procedures and / or accurate monitoring of the patient's urinary output. Similarly, the device can provide a simple method for priming the urine flow and / or removing obstructions (e.g., air locks) from the fluid line while maintaining sterility, thereby reducing the likelihood of urinary tract infections and / or other complications.
[0011] The headings provided herein are for convenience only and are not intended to limit or interpret the scope or meaning of the present technology.
[0012] 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 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.
[0013] The short-term effect of a diuretic on a patient's urine production can be difficult to predict, especially early in the course of treatment. For example, one patient may produce much less urine than would be expected for a given diuretic dose, whereas another patient administered the same dose may produce a very large amount of urine. Low urine production may prolong the treatment time and / or reduce the efficacy of treatment, 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's urination reaches a desired level and / or rate. However, this approach may prolong the time the patient remains in a fluid overload state, which may worsen the patient's underlying clinical condition. For example, conservative treatment procedures may result in significant fluid loss and may require hours or even days before the patient's urinary output becomes high enough to alleviate the fluid overload state. The patient may be hospitalized for several days (e.g., 4-5 days), which may be costly and burdensome. In addition, the long-term efficacy of treatment may be limited, such that approximately 25% of patients are re-admitted within 30 days for fluid overload.
[0014] To address these and other challenges, the present technology provides systems and related devices and methods for managing a patient's fluid levels. In some embodiments, the present technology can (i) improve the efficacy, safety, and quality of fluid management therapy, (ii) improve resource management in hospitals and other clinical settings, (iii) rapidly assess whether a patient has diuretic resistance, and / or (iv) improve diuretic efficiency (the amount of urine and / or excreted electrolytes (e.g., sodium) obtained by intravenous infusion of 1 mg of diuretic over a given time). The embodiments described herein can improve the net removal of fluid and / or electrolytes (e.g., sodium and / or chloride) and can treat fluid overload conditions more efficiently (e.g., with a shorter time frame and / or higher net fluid loss).
[0015] 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.
[0016] The urinary system 110 is configured to collect urine from a patient P and / or monitor the patient's urination (e.g., urination volume and / or urination rate). 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 (such as, for example, a Foley catheter, a Texas Condom catheter, a PureWick catheter, etc.) disposed in or otherwise connected to the bladder of the patient P.
[0017] In some embodiments, urine flow through the fluid line 119 is driven by patient urine production, gravity (e.g., the patient P's bladder is positioned 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 initiate 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 a desired flow rate during a treatment procedure and can operate continuously and / or periodically (e.g., at a predetermined time period) and / or in response to user input and / or detected problems (e.g., an unexpected interruption in urine flow). The pump can be used to clear air locks and / or other obstructions from the fluid line 119. Additional examples of devices suitable for priming fluid line 119 with fluid, pumping urine through fluid line 119, and / or removing air locks from fluid line 119 are described in further detail below with reference to Figures 10, 11, and 15A-15D.
[0018] 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 (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, a contact sensor (e.g., a paddle wheel sensor), and / or other sensors known in the art suitable for measuring the amount and / or rate of urination. 1A, the sensor 114 is located on the console 105. However, in other embodiments, some or all of the sensor 114 may be located in different locations within the system 100, such as on or in the line 119, the vessel 112, and / or the patient P.
[0019] In some embodiments, the sensor 114 may 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 may be configured to measure urine temperature, urine conductivity, urine oxygen saturation, urine specific gravity, and / or the concentration of one or more analytes (such as, for example, creatinine, sodium, potassium) in the urine. Such characteristics may be advantageous, for example, 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) may indicate whether the patient is responding well to a 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) may be used as a surrogate for the measurement of urine sodium and / or other urine electrolytes, e.g., higher urine conductivity may correlate to higher urine sodium concentration and lower urine conductivity may correlate to lower urine sodium concentration. As another example, urine temperature measurements can be used to detect urine flow (e.g., based on heat loss through fluid line 119). Urine temperature can be used as a surrogate for the patient's body temperature, in which case the urine temperature may correlate to the patient's current clinical condition.
[0020] 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 a blockage 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, catheter 118, and / or container 112). A leak may be detected based on a urine flow rate change, a pressure change, 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.
[0021] 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 air lock or other obstruction in the fluid line 119, a leak in the urinary system 110, and / or a kink 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 kink 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.
[0022] The rehydration system 120 may include at least one rehydration fluid source 122 ("fluid source 122", such as a bag, bottle, reservoir) 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) may be altered based on the patient's condition and / or expected or measured electrolyte losses during the treatment procedure.
[0023] 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).
[0024] 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 sensors 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., 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 infusion 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.
[0025] 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 be advantageous to improve accuracy of the measurements.
[0026] 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 evaluating, for example, whether the system 100 is ready to begin a fluid therapy treatment. Optionally, the sensor data can be used to detect whether a user attempts to remove an empty or nearly empty fluid source 122 during a treatment procedure, for example, to switch an empty or nearly empty fluid source 122 with 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 notifying the system 100 or manually pausing the procedure.
[0027] 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's identifier and / or concentration can be received by controller 140 by user input (e.g., with display 150), by scanning a bar code on diuretic source 134 or other diuretic container, and / or by any other suitable technique.
[0028] 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 diuretic through the fluid line 139 towards the patient P. The diuretic pump may include a peristaltic pump, a syringe pump, a metering pump, or other device suitable for delivering diuretic at multiple dosage rates to the patient P. The diuretic pump may deliver the diuretic according to any suitable delivery profile, for example, at a controlled continuous rate and / or in controlled boluses delivered at regular intervals through the fluid line 139. Additional details of the diuretic delivery profiles are provided below with respect to FIG. 2.
[0029] In some embodiments, the diuretic pump includes a mechanical syringe or plunger that is 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 connected 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 fluid from the diuretic source 134 toward the patient P through the line 139.
[0030] 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, a flow sensor, a weight sensor, 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 pumping speed (e.g., diuretic pump revolutions per minute, plunger position, etc.). The diuretic component 136 may include additional functional components, such as, for example, an air bubble detector, a pressure sensor, a blood spill sensor (e.g., an ivWatch device), and / or other implanted electronics to provide feedback signals to the controller 140 to ensure accurate diuretic infusion and / or monitor infusion status.
[0031] The controller 140 is configured to automatically control the infusion of hydration fluid and / or diuretic agent (e.g., based at least in part on the patient's urination) to facilitate safe and effective diuresis of the patient P. The controller 140 may include one or more processors and a tangible, non-transitory memory configured to store 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 generate 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 rate) 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.
[0032] 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 following patient parameters: 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 (such as, for example, creatine, sodium, potassium, chloride), 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.
[0033] To monitor and / or control this therapy, 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. 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 by system 100.
[0034] Display 150 (e.g., a touch screen, monitor, etc.) may include a user interface configured to accept 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. The 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 infusion rate (e.g., maximum, minimum, and / or average infusion rate), and / or average rehydration fluid infusion rate (e.g., maximum, minimum, and / or average infusion rate). The diuretic administration profile may include a diuretic administration time limit (e.g., maximum and / or minimum duration for diuretic delivery), 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 varied over time), a diuretic delivery time limit (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.
[0035] Alternatively or in combination, user input through the display 150 can prompt the controller 140 to retrieve treatment parameters (e.g., maximum diuretic dose, maximum continuous diuretic dose, and minimum desired urine rate) from tables and / or other data sources. The data sources can be stored within the system 100 (e.g., in a memory associated with the controller 140) and / or can be stored on a separate device (e.g., a remote computing device). In some embodiments, the 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, the controller 140 can be operably coupled to a communications device and / or interface configured to transmit and receive data over a communications network.
[0036] The controller 140 can output therapy parameters to the user through 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 for diuretic administration rates (e.g., initial, maximum, and / or minimum administration rates), rehydration fluid infusion rates (e.g., initial, maximum, and / or minimum infusion rates), urination rates (e.g., maximum and / or minimum excretion rates), and therapy duration (e.g., maximum duration for diuretic and / or rehydration fluid infusion, maximum total therapy 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.
[0037] 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, amount of rehydration fluid infused to date), diuretic delivery (e.g., current administration rate and / or volume, administration rate and / or volume over time, total amount of diuretic delivered to date), fluid residual (e.g., current fluid residual, fluid residual 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, reservoir volume remaining 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). A user can review the displayed information and provide inputs that instruct the controller 140 to adjust, pause, and / or stop the treatment procedure, if appropriate.
[0038] 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 a warning 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 in the system 100 rather than the user having to seek out a replacement elsewhere.
[0039] 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 treatment 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 induce a patient P to urinate larger volumes and / or higher rates of urination compared to conventional procedures, and therefore multiple containers 112 may be advantageous in reducing the number of times a user must empty and / or replace the containers 112 during the procedure.
[0040] 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 may issue a warning to the user indicating that the first container is full and needs to be replaced or emptied. This process may be repeated to ensure that 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 devices and methods relating thereto, are described below with reference to FIGS. 3-11.
[0041] As another example, the 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 hydration fluid sources 122 without interrupting hydration fluid infusion. In such an embodiment, the hydration system 120 may include a hydration control assembly (e.g., valves and / or other flow control components, not shown) operably coupled to the controller 140 and configured to switch the hydration fluid source from the first fluid source 122 to the second fluid source 122. In such an embodiment, the hydration control assembly may initially deliver hydration fluid from the first fluid source 122 to the patient P. The hydration control assembly may monitor whether the first fluid source 122 is empty or near empty, for example, based on data from the fluid sensor 128 and / or other sensors associated with the hydration system 120. When the hydration control assembly detects or determines that the first fluid source 122 is empty or nearly empty (e.g., the amount of hydration fluid remaining is less than a predetermined threshold), it can switch to delivering hydration fluid from the second source 122. This switching process can be repeated to prevent inadvertent interruption of fluid therapy due to an empty fluid source 122 and / or an inability of the hydration system 120 to provide hydration fluid.
[0042] 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 122 can be advantageous to 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 asking the user a question to confirm that hydration fluid should be switched from the first fluid source 122 to the second fluid source 122. When switching to the second fluid source 122, the controller 140 can issue an alert to the user indicating that the first fluid source 122 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.
[0043] 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 deemed to take into account 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.
[0044] 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 a medical 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 depleted, diuretic can continue to be provided (e.g., without substantial interruption) by a second diuretic source 134 (e.g., a second syringe or container). 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.
[0045] In some embodiments, the diuretic system 130 includes two independent diuretic pumps, each including its own diuretic 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 source 134 is empty or nearly empty (e.g., less than a predetermined threshold), the diuretic supply may be switched (e.g., automatically or manually) to the second diuretic source 134. In some embodiments, the diuretic system 130 may include one or more sensors configured to detect whether a backup syringe pump is available for use. The switching process can include stopping a first syringe pump fluidly coupled to the first syringe and starting a 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 a diuretic source 134. In such embodiments, case switching between the first diuretic source 134 and the second diuretic source 134 can 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 can 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.
[0046] The process of switching the diuretic source 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 be advantageous to 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 asking the user a question 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 issue 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 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, it may be necessary for the user to provide re-authorization before further automatic diuretic delivery.
[0047] In some embodiments, the different diuretic sources 134 of the diuretic system 130 may each provide the same type of diuretic. However, in other embodiments, some or all of the diuretic sources 134 may provide different types of diuretic. Depending on the patient's response to the diuretic, 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 poorly to the first diuretic (e.g., urination rate does not increase or increases 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 a notification requesting that the user approve the administration of a different diuretic, which may be advantageous with respect to patient safety.
[0048] The system 100 shown in FIG. 1A can have several configurations, including, for example, additional and / or fewer components. By way of example, FIG. 1B is a partial schematic diagram of another fluid management system 160 for monitoring urination and / or controlling fluid injection into a patient P according to an embodiment of the present technology. As shown in FIG. 1B, the system 160 can include a console 165 (e.g., console 105, FIG. 1A) and many of the same features as the system 100 (as previously described with reference to FIG. 1A), including a container 112 having a drainage valve 113, a catheter 118, a fluid line 119, and a controller 140. The 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. The flow control device 138 can be operably coupled to the controller 140 and configured to control flow from the patient to the container 112. In some embodiments, the flow control device 138 includes a pinch valve that controls flow by externally pinching the fluid line 119. As shown in FIG. 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.
[0049] The sensors 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 positioned external to the fluid line 119 and therefore does not contact the fluid within the fluid line 119.
[0050] 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 advantageous 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 with 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 derive average flow rates piecewise or to calculate 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.
[0051] In some embodiments, the signal from the second sensor 114b may be used as a primary information source or input, and the signal from the first sensor 114a may be used as a backup or secondary signal source. Alternatively, the signal from the first sensor 114a may be used as a primary information source, and the signal from the second sensor 114b may be used as a secondary signal source. The primary information source may be switched between the second sensor 114a and the second sensor 114b if (e.g., only if) the current sensor serving as the primary information source has failed or is unavailable, or other predetermined conditions are met. For example, in some embodiments, the signal from the second sensor 114b may be used as the primary information source unless and / or until (i) the weight of the container 112 is not greater than a predetermined threshold, indicating that the container 112 is nearly full and in need of draining, (ii) the weight of the container 112 is decreasing, indicating that the container 112 is likely drained, thereby reducing 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 the weight is decreasing, indicating that the container 112 is drained, thereby reducing 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 drained and / or one of the signals is inaccurate. If one or more of these conditions are met, the system 160 or controller 140 can (i) be configured to 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.).
[0052] In embodiments where a sensor used as a primary information 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 information 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 information 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 has not been closed or that urine is leaking.
[0053] In some embodiments, the difference 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 may cause the system 160 to stop all or part of the fluid therapy and / or warn the user that such a difference exists. In some embodiments, depending on whether and / or how long the first or second sensor 114a-114b has been determined to be offline or inaccurate, the system 160 or controller 140 may modify other phases 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, if a failure of any of the sensors 114a-114b is detected or if there is a large difference between the readings of the first sensor 114a and the second sensor 114b, a warning may be issued prior to the start of therapy to prevent use of the system in a non-functional state.
[0054] In some embodiments, the first sensor 114a (i.e., a flow sensor) is omitted and the second sensor 114b (i.e., a weight sensor) is relied upon to provide urine flow from the patient. In such embodiments, sensor data obtained from the second sensor 114b is utilized to determine an average urine flow rate over a period of time based, for example, on the rate of change of the weight of the container 112. Furthermore, 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 rely again on the signal to provide urine flow. During this predetermined period of time, the diuretic and / or rehydration fluid provided to the patient may be maintained and / or reduced.
[0055] Advantageously, system 160 and other embodiments of the present technology can remain operational and provide therapy even when container 112 is replaced and / or emptied. For example, first sensor 114a is upstream of 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 as the container is being replaced and / or emptied. Thus, unlike other embodiments that only have a sensor configured to measure the weight of container 112 and therefore cannot provide accurate urination measurements as the container is being replaced and / or emptied, embodiments of the present technology allow system 160 to continue to administer therapy uninterruptedly. Additionally or alternatively, embodiments of the present technology allow medical personnel to drain container 112 (e.g., through drain valve 113 of container 112), which may be prohibited and / or may result in inadvertently interrupting the patient's fluid therapy, without (i) being forced to replace container 112 or remove container 112 from the system, and (ii) using an interface of the system.
[0056] 1C is a partial schematic diagram of another fluid management system 170 for monitoring urination and / or controlling fluid injection into a patient P in accordance with an embodiment of the present technology. System 170 can include a console 175 (e.g., console 105, FIG. 1A) and many of the same features as system 100 and / or system 160. As shown in FIG. 1C, system 170 can further include an access door 176 that allows access to container 112 and a door-activated valve 178 (e.g., pinch valve) coupled (e.g., fluidly coupled) to and disposed between catheter 118 and container 112. Door 176 and valve 178 can be operably coupled to controller 140 such that controller 140 can determine whether each of door 176 and valve 178 is in an open or closed state and actuate valve 178 based on the position of door 176. Additionally or alternatively, valve 178 can be mechanically actuated by movement of door 176. For example, opening door 176 can mechanically close valve 178, and closing door 176 can open valve 178.
[0057] In operation, the valve 178 may be actuated, for example, by the controller 140 to close (i) when the door 176 is determined to be open or not closed, and (ii) when the door 176 is determined to be closed or not open. Thus, when the door 176 is opened to empty or replace the container 112, the controller may close the valve 178 to prevent urine from flowing out of the system 170 while urine accumulates in the patient's bladder. When the container 112 is emptied or replaced with a new empty container 112 and the door 176 is closed, the controller 140 may open the valve 178 to allow flow into the new container 112. At such time, it is contemplated that the volume of urine excreted while the door 176 was open and / or the valve 178 was closed may be measured by the second sensor 114b and / or the first sensor 114a.
[0058] 1D is a partial schematic diagram of another fluid management system 180 for monitoring urination and / or controlling fluid injection into a patient P in accordance with an embodiment of the present technology. The system 180 can include a console 185 (e.g., console 105, FIG. 1A) and many of the same features as the systems 100, 160, and / or 170. As shown in FIG. 1D, the system 180 can further include a reservoir 182 fluidly coupled to and disposed between the catheter 118 and the container 112. The reservoir 182 can be an expandable reservoir and / or configured to store a volume of fluid provided by the patient P. As shown in FIG. 1D, the reservoir 182 can be positioned between the first sensor 114a and the valve 178.
[0059] In operation, when the door 176 is opened to empty or replace the container 112, the valve 178 is actuated to a closed position and urine from the patient begins to accumulate in the reservoir 182. As described above, the valve 178 can be actuated by the controller 140 and / or mechanically actuated by the opening and closing of the door 176. Advantageously, because the reservoir 182 is located downstream of the first sensor 114a, the system 180 can remain online and does not have to pause or cease fluid therapy (e.g., infusion of diuretic and / or rehydration fluid) until the container 112 is replaced and / or the valve 178 is opened. Once the container 112 is emptied or replaced, flow to the container 112 can continue and the reservoir 182 can be drained.
[0060] In some embodiments, the system 180 may include other configurations that provide the same or similar functionality as those described above. For example, in some embodiments, the access door 176 is omitted, and the valve 178 is actuated based on a signal from the second sensor 114b. For example, in such an embodiment, the valve 178 is closed when the second sensor 114b detects a weight below a predetermined threshold, and the valve 178 is opened when the second sensor 114b detects a weight at or above the predetermined threshold. Alternatively, the system may include, for example, an optical or proximity sensor to detect when a user reaches into the area to empty the container 112, and close the valve 178 accordingly.
[0061] The systems 100, 160, 170, 180 shown in FIGS. 1A-1D can have several configurations. 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 various 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 for monitoring 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 using an outpatient environment, and it is believed that the urine bag can be emptied at any time without interrupting the continuous measurement of urine flow or volume.
[0062] 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. A diuretic with rehydration fluid infusion may be more advantageous 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 a diuretic 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 lower 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).
[0063] 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 professional according to techniques known to those skilled in the art.
[0064] Optionally, systems 100, 160, 170, 180 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.
[0065] 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 residual (net fluid loss). The method 200 (and other methods described herein) includes one or more steps, blocks, phases, acts, 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. In some embodiments, some or all of the stages 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 thereby, cause the system or device to perform one or more of the stages described herein. For example, the method 200 may be performed by the controller 140 of the system 100 of FIG. 1A. Optionally, some or all of the stages of the method 200 may be performed automatically or semi-automatically with little or no human involvement.
[0066] The method 200 may begin at stage 202 by obtaining a urination rate from a patient. 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). 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), volume, fluid level, and / or any other suitable parameter. The urination rate may be calculated based on the received input by a controller (e.g., controller 140 of FIG. 1A) operably coupled to the sensor. The urination rate may be the current rate or an average rate of rates measured over a predetermined period of time (e.g., the last 5 or 10 minutes). The urination rate may be updated continuously or repeatedly (e.g., every 30 seconds, every minute, every 2 minutes, etc.). In some embodiments, the processing of stage 202 is performed simultaneously with some or all of the other stages of method 200 (e.g., stages 204, 206, and / or 208) to provide continuous or substantially continuous urination monitoring throughout method 200.
[0067] At stage 204, the method 200 continues with delivering a diuretic to the patient at a dosage rate. The diuretic may 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 may be delivered automatically or semi-automatically by a diuretic system connected to the patient, such as the diuretic system 130 of FIG. 1A. The diuretic system may be operably coupled to a controller (e.g., the controller 140 of FIG. 1A) to cause diuretic delivery according to a planned and / or preprogrammed therapy regimen.
[0068] In some embodiments, the treatment procedure includes multiple phases, each phase associated with a different delivery profile for the diuretic. In such embodiments, stage 204 may be performed as part of an initial phase (also known as a "dose determination phase") that determines an appropriate diuretic administration rate for treating 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 steps of iteratively increasing the administration rate linearly, exponentially, according to a polynomial function and / or any other suitable rise function or rise profile. In some embodiments, the diuretic is delivered in a manner such that the subsequent administration rate is a predetermined percentage (such as, for example, at least 5%, 10%, 15%, 25%) greater 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 the patient's 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 in stage 208.
[0069] At stage 206, method 200 may optionally include providing a rehydration fluid to the patient at a rehydration rate. The rehydration fluid may include saline and / or other fluids having sodium and may 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 may be provided before, during, and / or after providing the diuretic at stage 204 (e.g., before, during, and / or after the titration phase). Intravenous infusion of a rehydration fluid containing electrolytes (e.g., sodium and / or chloride) may increase diuretic efficiency and is counterintuitive in that the goal of fluid therapy is net fluid removal. The rehydration fluid may reduce or inhibit intravascular depletion, reduce or inhibit the decline in cardiac output, and / or reduce or inhibit renal perfusion, among other benefits.
[0070] In some embodiments, rehydration fluid is provided to the patient based at least in part on a corresponding urination rate 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., 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 greater than or less 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.
[0071] At stage 208, 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 fluid loss from the patient. 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 at stage 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 a "continuous delivery phase" or a "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 elimination rate to cause a net fluid loss.
[0072] 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., bring the patient's urination closer to a constant or substantially constant rate), but 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).
[0073] 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.
[0074] In some embodiments, stage 208 includes delivering 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 a target net fluid loss volume is reached. During the fluid reduction phase, the diuretic administration rate may 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, stage 208 may include making additional adjustments to the diuretic administration rate (e.g., increasing and / or decreasing the diuretic administration rate) during the treatment procedure. These adjustments may be based on whether one or more of a set of predefined conditions are satisfied, such as whether the urination rate is excessively high. The set of conditions may include (i) the average urine rate is higher than a predefined rate over a period of time, (ii) the average rate of change in urine rate is greater than a predefined rate, and / or (iii) the diuretic administration rate is higher than a predefined 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."
[0075] In some embodiments, the downward titration is performed only when all or most of the above conditions are met, thereby avoiding unnecessary reductions in the diuretic administration rate and thus avoiding unnecessary interruptions in the treatment procedure while the urination rate remains high. For example, whereas other methods 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 processes 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 processes herein may prevent unnecessary reductions in the diuretic administration rate when the urination rate is temporarily high (e.g., greater than a predetermined rate) but trending downward. This method may prevent or reduce excessive diuresis, excessive fluid loss, and / or electrolyte loss, and further limit the patient's unnecessary exposure to additional diuretic. Additionally, rather than stopping the diuretic completely, the diuretic administration rate can be titrated down so that fluid therapy can continue (albeit at a lower voiding rate) without having to restart the procedure entirely.
[0076] As another example, further adjustment of the diuretic administration rate at stage 208 may include increasing the diuretic administration rate, also referred to herein as "re-start" or "up-titration." In some embodiments, re-start is performed if the urination rate is too low, as determined based on a set of conditions. The set of conditions may include (i) the average urination rate being less than a predetermined threshold rate for a predetermined period of time, and / or (ii) a debt greater than a predetermined amount accumulating for a predetermined period of time. The "debt" 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 of and how long the urination rate was below the set rate. If some or all of these conditions are met, re-start may be performed by gradually increasing the diuretic administration rate until (i) a predetermined amount of time has elapsed, and / or (ii) the urination rate is greater than or equal to the predetermined threshold rate. The restart process, at stage 204, may be the same as or substantially similar to the dosage determination process described above.
[0077] The reactivation process can be performed automatically, semi-automatically, or manually. In some embodiments, reactivation is a semi-automatic or manual process that requires user approval, for example for calibration and / or safety reasons. In such embodiments, the system can output a notice to the user (e.g., through the FIG. 1A display 150) instructing the user to confirm that reactivation is to be initiated. Optionally, the system can perform a pre-approval procedure that can enable the user to automatically perform reactivation under certain conditions (e.g., within a certain period of time until a pre-defined voiding volume and / or voiding rate is reached, such as for a maximum diuretic amount and / or maximum diuretic administration rate). This method can enable automatic reactivation under limited circumstances, which can reduce the amount of human involvement during the treatment procedure and improve the responsiveness of the system to address the patient's current condition. Once the pre-approval condition has passed, the user may need to give re-approval before additional automatic reactivation is allowed.
[0078] In some embodiments, stage 208 further includes adjusting the diuretic administration rate in response to an obstruction (e.g., an air lock, kink, etc.) detected in the urine collection system. For example, an air lock may be any partial or complete obstruction of fluid flow due to gas (e.g., air) trapped in the fluid system. Examples of conditions under which an air lock may occur are described in more detail below with respect to FIGS. 6A and 6B. As described elsewhere herein, an air lock may cause an unnatural drop in urination rate, which may affect diuretic administration rate determinations (e.g., causing an excessively high diuretic administration rate). In some embodiments, the presence of an air lock is detected based on a period of little or no urination (due to the air lock obstructing urine flow) followed by a sudden, large bolus of urination (due to built-up pressure in the fluid line that clears the air lock). When the system detects that an air lock 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 air lock 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 air lock occurred, the diuretic administration rate calculated from the patient's urination rate before the air lock occurred, etc.).
[0079] Alternatively or in combination, stage 208 may include adjusting the hydration rate, for example, by increasing or decreasing the patient's urination rate to drive net fluid loss from the patient. For example, as described above, initially the hydration rate may correspond to 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 experiences 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 greater than or less 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 manner.
[0080] 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 (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)) for a predetermined period of time if a low blood pressure level is detected. 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 issue an alert and / or adjust diuretic administration rate and / or rehydration rate if the patient's blood pressure is low and the patient's urination rate drops. This method can improve patient safety and control of the treatment procedure.
[0081] In some embodiments, some or all of the stages 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 using 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).
[0082] The method 200 shown in FIG. 2 can be modified in many different ways. For example, any of the stages of the method 200, such as stage 204 or 206, can be omitted. In some embodiments, stage 204 is omitted, and thus the method 200 controls rehydration fluid infusion but does not control diuretic delivery or does not include any diuretic delivery at all. Similarly, stage 206 can be omitted, and thus the 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 stages 200 of the method 200 can be performed in a different order and / or repeated (e.g., any of 202, 204, 206, and / or 208). In yet another example, the method 200 can include additional stages not shown in FIG. 2 (e.g., causing delivery of additional drugs, obtaining parameters other than urination rate, etc.).
[0083] 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 a patient's fluid volume more quickly and safely than conventional treatment systems and therapies. For example, while conventional methods may generally 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 in less than 24 hours. In addition to this, embodiments of the present technology have also been shown to remove a sufficient amount of salt through hypernatremia from the patient. This salt removal can reduce the likelihood of a patient reaccumulating fluid after discharge, thereby causing a reduction in 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).
[0084] Embodiments of the present technology can provide various advantages, such as: (i) optimizing net fluid volume removal; (ii) reducing the time required to cause a desired net fluid removal by allowing physicians to use higher diuretic doses and / or administration rates early in treatment compared to conventional treatment; (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.
[0085] II. URINE COLLECTION SYSTEMS AND RELATED DEVICES AND METHODS Figures 3-8 and the associated discussion provide various examples of urine collection systems and related devices and methods suitable for use with the fluid management system 100 of Figure 1A and / or the method 200 of Figure 2. Any of the features of the embodiments of Figures 3-8 may be combined with one another and / or incorporated into any of the other embodiments of the present technology. For example, any of the embodiments of Figures 3-8 may be combined with and / or incorporated into the urine system 110 of Figure 1A.
[0086] A. Systems, Devices, and Methods Using Multiple Urine Collection Containers Figures 3-4J illustrate various examples of urine collection systems configured in accordance with embodiments of the present technology. Specifically, Figure 3 provides an overview of the components of a urine collection system, and Figures 4A-4J provide representative examples of urine collection systems. Any of the features of the embodiments of Figures 3-4J can be combined with each other and / or with any of the other systems and devices described herein (e.g., system 100 of Figure 1A).
[0087] 3 is a schematic diagram of a urine collection system 300 configured in accordance with an embodiment of the present technology. System 300 may be used to collect urine from a patient during a medical procedure where the patient is expected to produce a large total volume of urine (e.g., at least 2L, 5L, 10L, 15L, or 20L of urine in a 24 hour period) and / or exhibit a high urination rate (e.g., at least 0.5L / hr, 1L / hr, 1.5L / hr, 2L / hr, or 2.5L / hr). However, in other embodiments, system 300 may be used in any procedure involving collecting urine from a patient and / or monitoring the patient's urination.
[0088] The system 300 includes a flow control assembly 302 operably coupled to a plurality of urine collection containers. In the illustrated embodiment, for example, the system 300 includes a first collection container 304a and a second collection container 304b for receiving urine or other bodily fluids. However, in other embodiments, the system 300 can include a different number of containers 304a-304b, such as three, four, five, six or more containers 304a-304b. The containers 304a-304b can be any flexible or rigid container suitable for holding urine from a patient, such as a bag, bottle, can, vial, or the like. Each of the containers 304a-304b can have an internal volume of at least 0.5L, 1L, 1.5L, 2L, or 5L.
[0089] The flow control assembly 302 is configured to direct urine from the patient into one or more of the containers 304a-304b. As shown in FIG. 3, the system 300 receives urine from the patient through an intake fluid line 306, which may be coupled to the patient's body through a catheter (e.g., a Foley catheter, a Texas Condom catheter, a PureWick catheter, etc.). The intake fluid line 306 may be connected to multiple fluid lines (e.g., a first fluid line 308a and a second fluid line 308b), each of which connects to one of the containers 304a-304b. In the illustrated embodiment, for example, the first fluid line 308a connects the first container 304a to the intake fluid line 306, and the second fluid line 308b connects the second container 304b to the intake fluid line 306. In other embodiments, the system 300 may include a different number of fluid lines depending on the number of containers 304a-304b used.
[0090] In some embodiments, the flow control assembly 302 includes a first subassembly 310a and a second subassembly 310b configured to control fluid flow from the patient to the first and second containers 304a-304b, respectively. The first subassembly 310a can be operably coupled to the first container 304b and / or the first fluid line 308a, and the second subassembly 310b can be operably coupled to the second container 304b and / or the second fluid line 308b. Each of the subassemblies 310a-310b can include various components for controlling and / or monitoring urine output into the respective containers 304a-304b, such as one or more sensors, valves, and / or retainers, as described in more detail below. The flow control assembly 302 can further include a controller 312 (e.g., a microprocessor) operably coupled to the subassemblies 310a-310b to control the operation of these subassemblies. Controller 312 can receive and process data from subassemblies 310a-b, send control signals to subassemblies 310a-b, and / or send data to a separate device (e.g., a user device such as a smart phone, such as controller 140 of FIG. 1A). Additional details of the operation of controller 312 are provided below.
[0091] The sensors (e.g., the first sensor 314a and the second sensor 314b) may be or include any device configured to measure the amount of urine in the corresponding receptacles 304a-304b and / or the rate of urine flow to those receptacles. For example, the sensors 314a-314b may include weight sensors, flow rate sensors, fluid level sensors, float sensors, optical sensors, drip counters, etc. The sensors 314a-314b may be included in or coupled to the receptacles 304a-304b, the fluid lines 308a-308b, and / or any other suitable portion of the system 300. The controller 312 may receive and process the sensor data generated by the sensors 314a-314b to determine the amount of urine in each receptacle 304a-304b and / or the rate of urine flow to each receptacle 304a-304b. Based on these calculations, the controller 312 can evaluate the status of each container 304a-304b (e.g., full, partially full, empty) and determine whether the container 304a-304b is available to hold urine, needs to be emptied, etc.
[0092] The valves (e.g., the first valve 316a and the second valve 316b) may be or include any device configured to control fluid flow to the respective container 304, such as, for example, pinch valves, ball valves, butterfly valves, diaphragm valves, check valves, and the like. Each valve 316a-316b may be coupled to an actuator (e.g., a servo motor, not shown in FIG. 3) that actuates the valve 316a-316b between an open configuration that allows fluid flow and a closed configuration that prevents fluid flow. A controller 312 may be operably coupled to the actuator to control whether the corresponding valve 316a-316b is in an open or closed state. Thus, by selectively opening and closing the valves 316a-316b, the controller 312 may direct urine flow from the patient to a particular container 304a-304b and / or prevent urine from flowing into a particular container 304a-304b.
[0093] The retainers (e.g., first retainer 318a and second retainer 318b) may be or include any device, e.g., latches, fasteners, etc., configured to secure the corresponding container 304a-304b to the flow control assembly 302. The retainers 318a-318b may prevent the container 304a-304b from inadvertently becoming dislodged or detached during a procedure, thus reducing the possibility of spillage or leakage. Each retainer 318a-318b may be coupled to an actuator (not shown in FIG. 3) that actuates the retainer 318a-318b between an unlocked configuration and a locked configuration. For example, a controller 312 may be operably coupled to the actuator to control whether the corresponding retainer 318a-318b is in a locked or unlocked state. The controller 312 may coordinate the state of each retainer 318a-318b with the corresponding valve 316a-316b. For example, when the first valve 316a is in an open state, and thus urine is flowing into the first container 304a, the controller 312 can lock the first holder 318a, and thus the first container 304a cannot be removed. As another example, when the second valve 316b is in a closed state, and thus urine is not flowing into the second container 304b, the controller 312 can unlock the second holder 318b, and thus allow the second container 304b to be removed (e.g., to empty the second container 304b). Alternatively or in combination, the first and second holders 318a-318b can be manually activated by a user (e.g., in response to a notification or alarm, such as a light, sound, message, etc.). However, in other embodiments, the first and second holders 318a-318b are optional and can be omitted.
[0094] The system 300 of FIG. 3 can include many different approaches. For example, while the illustrated embodiment shows two separate subassemblies 310a-b, in other embodiments, the subassemblies 310a-b can be combined into a single component. In addition, while FIG. 3 shows a single controller 312, in other embodiments, the controller 312 can be implemented as multiple individual controllers (e.g., one controller for each subassembly 310). Optionally, the controller 312 can be located partially or completely outside of the flow control assembly 302 (e.g., as part of a console for a larger patient fluid management system). For example, the controller 312 can be the controller 140 of the system 100 of FIG. 1A. The locations of the various components shown in FIG. 3 can be changed as desired. For example, the sensors 314a-b can be in or on any of the containers 304a-b, in or on any of the fluid lines 308a-b, or in any other suitable location within the system 300. Additionally, the system 300 can include a varying number of vessels 304a-b, subassemblies 310a-b, sensors 314a-b, valves 316a-b, and / or retainers 318a-b.
[0095] Figures 4A-4J illustrate examples of urine collection systems 400 constructed in accordance with embodiments of the present technology. More specifically, Figure 4A is a perspective view of system 400, and Figures 4B-4J are various views of a flow control assembly 402 of system 400.
[0096] Referring initially to FIG. 4A, system 400 includes a flow control assembly 402 operably coupled to a first container 404a and a second container 404b. Flow control assembly 402 can monitor and / or control urine flow from a patient into containers 404a-404b as described in more detail below. System 400 can include additional functional components, such as any of the components for monitoring and / or managing fluid levels described above with reference to FIG. 1A. In the illustrated embodiment, for example, system 400 is configured as a console 406 including flow control assembly 402, a hydration system for delivering fluid (e.g., saline solution) from a fluid source 408, a diuretic system for delivering a diuretic from a diuretic source 410, a computer or controller 412 (shown only diagrammatically), and a user input / output device (e.g., a touch screen or display 414). 4A, the containers 404a-404b can be located on a lower portion of the console 406 and / or relatively close to the floor. This arrangement can create a stronger siphon vacuum in the fluid lines connected to the patient, which can improve urine collection by reducing fluid pooling in the bladder and / or by avoiding large boluses of urine when the patient moves, and / or by removing small air bubbles in the fluid lines, reducing the possibility of air locks. However, in other embodiments, components of the console 406 can be positioned differently or omitted.
[0097] 4B is a perspective view of flow control assembly 402 with receptacles 404a-404b. Flow control assembly 402 can include a frame 420 configured to connect receptacles 404a-404b to console 406 (FIG. 4A). Receptacles 404a-404b can each be a flexible bag, a rigid bottle, or any other structure suitable for holding urine (e.g., as described above with reference to FIG. 3). In the illustrated embodiment, frame 420 is configured as a generally rectangular support structure having openings 422 for receiving first and second subassemblies 424a-424b. The first subassembly 424a can be coupled to the first container 404a to control urine flow through the first fluid line 426a into the first container 404a, and the second subassembly 424b can be coupled to the second container 404b to control urine flow through the second fluid line 426b into the second container 404b. The first and second fluid lines 426a-426b can be fluidly coupled to an intake fluid line (not shown) through fittings (e.g., Y fittings), manifolds, or other suitable connectors. The subassemblies 424a-424b can include sensors, valves, retainers, etc. for monitoring and / or controlling urine flow into the respective containers 404a-404b as discussed above with reference to FIG.
[0098] 4C-4J are various views of the individual vessels 404 and subassemblies 424 of the flow control assembly 402. Any of the features of the vessels 404 may be incorporated into the first vessel 404a and / or second vessel 404b of Figures 4A and 4B, and any of the features of the subassembly 424 may be incorporated into the first and / or second subassemblies 424a-b of Figures 4A and 4B.
[0099] Referring first to FIG. 4C, which is a perspective view of the vessel 404 with a subassembly 424, the subassembly 424 is configured to connect the vessel 404 to the rest of the flow control assembly 402. The subassembly 424 can monitor and / or control fluid flow into the vessel 404 through a fluid line 426. As shown in FIG. 4C, the subassembly 424 can include an upper section 428 and a lower section 430. Although the upper and lower sections 428, 430 are shown as having a generally rectangular shape, in other embodiments, the upper and / or lower sections 428, 430 can have different shapes (e.g., square, oval, etc.). The upper section 428 can be a mounting plate for mounting to the frame 420 (FIG. 4B) of the flow control assembly 402, while the lower section 430 can be a nest or receptacle for receiving and supporting the vessel 404. The lower section 430 may be connected to any suitable portion of the vessel 404, such as a cap 432 on an upper portion of the vessel 404. In the illustrated embodiment, the cap 432 is coupled to an interface cartridge 434, which fits within an opening 436 in the lower section 430 of the subassembly 424.
[0100] FIG 4D is a left perspective view of the interface cartridge 434 attached to the container 404, and FIG 4E is a right exploded perspective view of the interface cartridge 434 and container 404. Referring initially to FIG 4D, the interface cartridge 434 is configured to be removably coupled to the container 404 through a cap 432, which can be a rigid structure connected to or integrally formed with an upper end of the container 404. Optionally, the cap 432 can include a handle 438 having ergonomic features (e.g., texture, ridges, etc.) such that a user can grasp the handle 438 to insert, remove, and / or otherwise manipulate the container 404.
[0101] 4E, the cap 432 includes an opening 440 that allows for fluid flow into the vessel 404. The interface cartridge 434 can fit at least partially into the opening 440 in the cap 432 to provide a fluid-tight seal. In the illustrated embodiment, the opening 440 has an elongated shape, and the interface cartridge 434 includes a corresponding elongated bottom section 442 that fits into the opening 440. The cap 432 and / or the interface cartridge 434 can be secured together by any suitable technique, such as an interference fit, snaps, latches, fasteners, magnetic elements, and the like. The coupling between the cap 432 and the interface cartridge 434 can be a temporary releasable connection such that a user can separate the cap 432 and vessel 404 from the interface cartridge 434 by pulling a handle 438 of the cap 432. The cap 432 may further include at least one slot or recess 444 configured to secure the cap 432 and container 404 to the subassembly 424, as described in more detail below with respect to Figures 4G-4J.
[0102] The interface cartridge 434 can fluidly couple the fluid line 426 to the container 404. In the illustrated embodiment, the interface cartridge 434 includes a receptacle 446 that receives a proximal portion 448 of the fluid line 426. The receptacle 446 can be a hollow structure or housing positioned on a top surface 450 of the interface cartridge 434. To allow fluid to flow from the proximal portion 448 of the fluid line 426 into the container 404, the interface cartridge 434 can include a channel or hole 447 (shown in FIG. 4J) that extends from the receptacle 446 through the elongated bottom section 442. Thus, when the interface cartridge 434 is assembled onto the cap 432 (shown in FIG. 4D), fluid in the fluid line 426 can flow through the channel 447 of the interface cartridge 434 and into the opening 440 of the container 404.
[0103] 4D, in some embodiments, the receptacle 446 includes a window 452 (e.g., an opening, a notch, etc.) that exposes a section 454 of the proximal portion 448 of the fluid line 426. The exposed section 454 of the fluid line 426 can interface with a corresponding valve in the subassembly 424 (FIG. 4C) to control fluid flow into the container 404, as described in more detail below with reference to FIGS. 4G-4J.
[0104] FIG. 4F is a top perspective view of the subassembly 424, FIGS. 4G-4I are bottom perspective views of the subassembly 424, and FIG. 4J is a bottom perspective view of the subassembly 424 connected to the cap 432 and the interface cartridge 434. Referring initially to FIG. 4F, the lower section 430 of the subassembly 424 can include a front surface 456 having an opening 436 for receiving at least a portion of the interface cartridge 434. The shape of the opening 436 can be complementary to the shape of the interface cartridge 434. For example, in FIG. 4F, the opening 436 includes an upper portion 458 configured to include the receptacles 446 and / or fluid lines 426 of the interface cartridge 434 and a lower portion 460 configured to include at least a portion of the top surface 450 and bottom section 442 of the interface cartridge 434. As shown in FIG. 4G, the opening 436 can be connected to a cavity 462 in the bottom surface 464 of the lower section 430. The cavity 462 can have an elongated shape similar to the shape of the interface cartridge 434 such that the interface cartridge 434 can fit at least partially within the cavity 462 .
[0105] 4J, the lower section 430 of the subassembly 424 can engage an interface cartridge 434 and a cap 432 to secure the container 404 to the subassembly 424 (the container 404 is omitted from FIG. 4J for simplicity). To connect the container 404 to the subassembly 424, a user can slide the interface cartridge 434 and the cap 432 along a bottom surface 464 of the lower section 430 (e.g., along a direction D1) such that the interface cartridge 434 at least partially enters the cavity 462 through the opening 436.
[0106] The lower section 430 may additionally include at least one sensor configured to detect whether the container 404 (connected to the lower section 430) is present. The sensor may be or include any of a mechanical sensor (e.g., a switch), an optical sensor, a sensor (e.g., an RFID reader) configured to detect signals from tags on the container 404, the cap 432, and / or the interface cartridge 434, or any suitable combination thereof. In the illustrated embodiment, for example, the lower section 430 includes a first sensor 466 configured to detect the presence of the interface cartridge 434 and a second sensor 468 configured to detect the presence of the cap 432 (which may serve as a surrogate for the presence of the container 404). The first sensor 466 may be a first mechanical sensor (e.g., a first microswitch) that is activated (e.g., depressed) when the interface cartridge 434 is in the cavity 462 (e.g., fully inserted into the cavity 462). Similarly, the second sensor 468 can be a second mechanical sensor (e.g., a second microswitch) that is activated (e.g., depressed) when the cap 432 is positioned adjacent or near the bottom surface 464 of the lower section 430. The first sensor 466 and the second sensor 468 can be independently activated, such that the flow control assembly 402 can determine whether the interface cartridge 434, the container 404, or both have been removed from the subassembly 424. Each of the first and second sensors 466, 468 can be at or near the end of the cavity 462 remote from the opening 436 such that the sensors 466, 468 are activated only when the interface cartridge 434 and cap 432 are properly engaged with the cavity 462. In other embodiments, the first and / or second sensors 466, 468 may be in a different location on the lower section 430 (e.g., a different location relative to the cavity 462), or may be positioned on the upper section 428 rather than the lower section 430, or may be excluded entirely.
[0107] Referring again to FIG. 4F, the subassembly 424 may further include at least one sensor configured to monitor the amount of fluid in the container 404 and / or the rate of fluid flow into the container 404. The sensor may be or include any of the sensors discussed above with reference to FIG. 3, such as a weight sensor, a flow sensor, a fluid level sensor, a float sensor, an optical sensor, or a drip counter. In the illustrated embodiment, for example, the upper section 428 includes a weight sensor 470 (e.g., a load cell) configured to measure the weight of the container 404 when the container 404 is coupled to the lower section 430. The lower section 430 may be connected to the upper section 428 by a slidable connection such that the lower section 430 may translate upwardly and / or downwardly (e.g., along a vertical axis D2) relative to the upper section 428. 4F, the lower section 430 may include one or more pins 472 (shown in dashed lines) that slidably fit into corresponding holes 474 in the upper section 428. Thus, when the container 404 is attached to the lower section 430, the weight of the container 404 may displace the lower section 430 downward. A weight sensor 470 may be coupled to the lower section 430 such that the downward displacement of the lower section 430 applies a force to the weight sensor 470, which may output a sensor signal indicative of the weight of the container 404 in response to the applied force.
[0108] The fit between the upper section 428 and the lower section 430 is tight enough to facilitate removal and insertion of the container 404 and / or the interface cartridge 434, while at the same time being loose enough to provide accurate weight measurements. For example, if the fluid distribution in the container 404 is eccentric, an overly tight fit between the upper section 428 and the lower section 430 may cause uneven loading and / or drag on the pin 472, which may interfere with measurements generated by the weight sensor 470. Thus, the subassembly 424 may optionally include an adjustment mechanism that can alter the fit between the upper section 428 and the lower section 430. In some embodiments, when the container 404 and / or the interface cartridge 432 are being removed from and / or inserted into the subassembly 424, the adjustment mechanism provides a tight fit between the upper section 428 and the lower section 430 to facilitate removal and / or insertion. Once the container 404 and / or interface cartridge 432 are connected to the subassembly 424, the adjustment mechanism can loosen the fit between the upper section 428 and the lower section 430 such that the lower section 430 hangs freely with little or no contact with the pin 472 from the weight sensor 470. Optionally, the adjustment mechanism can automatically lock the container 404 and / or interface cartridge 432 to the subassembly 424 while the upper and lower sections 428, 430 are loosely engaged. The adjustment mechanism can include any suitable combination of actuators, latches, and the like, and can be actuated manually by a user, automatically by a controller, or any suitable combination thereof.
[0109] Referring again to FIG. 4G, subassembly 424 further includes at least one valve for controlling fluid flow to container 404. The valve may be or include any of the embodiments discussed with reference to FIG. 3 above, such as a pinch valve, a ball valve, a butterfly valve, a diaphragm valve, a check valve, etc. In the FIG. 4G embodiment, lower section 430 includes a cam unit 476 having an elongated arm 478 that acts as a pinch valve. Cam unit 476 may be positioned near cavity 462 and / or near an access slot 480 connected thereto such that rotation of cam unit 476 moves elongated arm 478 through access slot 480 and thus into and / or out of cavity 462. For example, cam unit 476 can rotate clockwise (e.g., along direction D3) to move elongated arm 478 into cavity 462 and can rotate counterclockwise (e.g., along direction D4) to move elongated arm 478 out of cavity 462. Subassembly 424 can further include an actuator 482 (e.g., a servo motor, FIG. 4F) operably coupled to cam unit 476 to actuate rotation of cam unit 476. Actuator 482 can be present in upper section 428, lower section 430, or any other suitable location within subassembly 424.
[0110] In some embodiments, the cam unit 476 is configured to rotate between a number of different positions to control fluid flow into the container 404. For example, the cam unit 476 can rotate between a first position that allows fluid flow into the container 404 and a second position that blocks fluid flow into the container 404. When the cam unit 476 is in the second position (e.g., as shown in FIG. 4G ), the elongated arm 478 can extend into the cavity 462 and engage (e.g., press against) the exposed section 454 of the fluid line 426 carried by the interface cartridge 434 ( FIGS. 4D and 4E ), thereby occluding fluid flow into the container 404. Conversely, when the cam unit 476 is in a first position (e.g., as shown in FIG. 4H ), the elongated arm 478 (hidden in FIG. 4H ) can be moved away from the cavity 462 such that the elongated arm 478 disconnects from the exposed section 454 of the fluid line 426 and allows fluid to flow unobstructed or substantially unobstructed into the container 404.
[0111] Optionally, the subassembly 424 further includes at least one retainer (e.g., a latch, fastener, etc.) configured to engage a portion of the container 404 (e.g., the cap 432) to secure the container 404 to the subassembly 424. For example, the cam unit 476 can include a protrusion 484 that acts as a retainer. The protrusion 484 can fit into a portion of the container 404 to prevent the container 404 from being removed from the subassembly 424. In the illustrated embodiment, for example, the protrusion 484 has a geometry (e.g., size, shape) similar to the geometry of the slot 444 in the cap 432. Thus, when the interface cartridge 434 and the cap 432 are connected to the bottom section 430 of the subassembly 424 (e.g., as shown in FIG. 4J), the protrusion 484 can at least partially fit into the slot 444 to latch the cap 432 (and thus the container 404) to the subassembly 424.
[0112] In some embodiments, the retainer (e.g., protrusion 484) cooperates with and / or is operably coupled to a valve (e.g., elongated arm 478) such that the container 404 cannot be removed from the subassembly 424 when fluid is flowing into the container 404. In the illustrated embodiment, the protrusion 484 and the elongated arm 478 are both connected to the cam unit 476 such that the cam unit 476 controls the position of both the protrusion 484 and the elongated arm 478. The protrusion 484 can be rotationally offset from the elongated arm 478 to be disconnected from the container 404 when the elongated arm 478 attempts to engage the fluid line 426 and to engage the container 404 when the elongated arm 478 is disconnected from the fluid line 426. For example, when the cam unit 476 is in the second position (e.g., as shown in FIG. 4G), the protrusion 484 can be spaced from the cavity 462 and can be disconnected from the slot 444 of the cap 432. When cam unit 476 is in a first position (e.g., as shown in FIG. 4H ), protrusion 484 can reside in or near cavity 462 and can also at least partially fit into slot 444, thereby locking cap 432 (and thus container 404) to subassembly 424. However, in other embodiments, subassembly 424 can include a retainer that operates independently of the valve (e.g., a retainer that is not positioned on and / or coupled to cam unit 476).
[0113] 4D , the interface cartridge 434 can optionally include a second retainer for locking the interface cartridge 434 to the subassembly 424 such that the container 404 can be removed from the subassembly 424 independently of the interface cartridge 434. In the illustrated embodiment, for example, the second retainer is configured as a latch 486 (e.g., a ramp, protrusion, etc.) extending from a top surface 450 of the interface cartridge 434. When the interface cartridge 434 is inserted into the opening 436 of the subassembly 424, the latch 486 can engage a corresponding notch or recess 488 ( FIG. 4G ) near the opening 436. Contact between the latch 486 and the notch 488 can prevent the cartridge 434 from being removed from the subassembly 424. Thus, such as when a user desires to remove the container 404 without removing the interface cartridge 434 (e.g., to empty and / or replace the container 404 during a treatment procedure), the interface cartridge 434 can remain secured to the subassembly 424 (e.g., within the cavity 462 of the lower section 430), while the cap 432 can be separated from the interface cartridge 434. Thus, a user can remove the container 404 from the subassembly 424 with little or no disruption to the fluid lines 426 connected to the patient, thereby reducing the chance of infection and / or contamination. Optionally, the interface cartridge 434 can include a movable flap, seal, barrier, or the like, that temporarily seals off the exposed ends of the fluid lines 426 (e.g., by covering the channel 447 (FIG. 4J)) to maintain sterility of the fluid lines 426 until the container 404 is reconnected.
[0114] 4I, in some embodiments, the cam unit 476 is rotatable to a third position that allows both the interface cartridge 434 and the container 404 to be removed from the subassembly 424. For example, as shown in FIG. 4I, when the cam unit 476 is in the third position, the protrusion 484 and the elongated arm 478 (hidden in FIG. 4I) can be oriented such that they are spaced apart from the cavity 462 and disconnected from the cap 432 and the fluid line 426, respectively. The cam unit 476 can be positioned in the third position when a user initially connects the interface cartridge 434 and the container 404 to the subassembly 424 (e.g., during a setup procedure). The cam unit 476 can also be in the third position when a user seeks to remove the interface cartridge 434 and the container 404 from the subassembly 424 (e.g., after a treatment procedure is completed).
[0115] 4C and 4D together, to remove the interface cartridge 434 from the subassembly 424, a user can depress a trigger 490 on the interface cartridge 434. The trigger 490 can be an elongated lever that remains disposed outside of the opening 436 when the interface cartridge 434 is coupled to the subassembly 424. The trigger 490 can be adjacent to or otherwise connected to the latch 486 such that when a user depresses the trigger 490, the latch 486 is disengaged from a notch 488 ( FIG. 4F ) in the subassembly 424, thereby allowing the interface cartridge 434 to slide out of the opening 436.
[0116] The mechanism for securing the container 404 and / or the interface cartridge 434 can include many different approaches. In other embodiments, for example, the container 404 can be locked to the interface cartridge 434 in addition to or instead of being locked to the subassembly 424. This method can be used for situations where the interface cartridge 434 is removed only once per treatment procedure (e.g., after the procedure is completed). Locking the container 404 to the interface cartridge 434 can reduce the possibility of the container 404 being inadvertently disengaged when it is not receiving any urine (and thus is not locked to the subassembly 424 by the cam unit 476). This can be advantageous when the console 406 is moved, for example, to allow the patient to move around during treatment. In such an embodiment, the retainer for locking and unlocking the interface cartridge 434 can be controlled by the subassembly 424 (or other components of the console 406) rather than the trigger 490. Alternatively, the trigger 490 can be used to disengage the container 404 from the interface cartridge 434 when the container 404 is not receiving fluid (e.g., the cam unit 476 has not locked the container 404 to the subassembly 424). Alternatively, the subassembly 424 can include a separate electromagnetic latch or other retainer for locking and unlocking the container 404 to and from the cartridge 434 that can be actuated by releasing a button on the console 406, by entering a command through the touch screen 414, or by any other suitable technique.
[0117] Optionally, subassembly 424 may include or be operatively coupled to at least one notification device configured to output status notifications that may inform a user of any of the following statuses: container 404 is present, container 404 is not present, container 404 is empty, container 404 is partially full, container 404 is completely full, an amount of fluid in container 404 is greater than or equal to a threshold, an amount of fluid in container 404 is less than or equal to a threshold, container 404 is currently in a locked state, container 404 is currently in an unlocked state, interface cartridge 434 is currently in a locked state, interface cartridge 434 is currently in an unlocked state, a system error exists, and the like.
[0118] Referring again to FIG. 4F, the notification device can include a set of indicator lights 492 (e.g., LED lights). Although FIG. 4F shows two indicator lights 492 positioned on the upper section 428 of the subassembly 424, in other embodiments, some or all of the indicator lights 492 can be positioned on different portions of the subassembly 424 (e.g., the lower section 430), different portions of the flow control assembly 402, and / or different portions of the system 400. Each indicator light 492 can turn on, turn off, blink, change color, etc. to indicate the status of the subassembly 424 and / or the vessel 404. Alternatively or in combination, the notification device can be configured to output other types of notifications, such as sounds or messages. The notification messages can be displayed on the touch screen 414 of FIG. 4A and / or can be sent to a separate device (e.g., the user's mobile device, pager, computer, etc.).
[0119] The subassembly 424 may include or be operatively coupled to a controller (e.g., a microprocessor, not shown) configured to control the various functional components described herein (e.g., location sensors 466, 468, weight sensor 470, cam unit 476, actuator 482, and / or indicator light 492). For example, the controller may receive and process sensor data from the location sensors 466, 468 to detect whether the interface cartridge 434 and the vessel 404 are coupled to the subassembly 424, respectively. The controller may receive and process sensor data from the weight sensor 470 to measure the amount of fluid in the vessel 404. Optionally, the actuator 482 and / or the cam unit 476 may include a position sensor (e.g., a potentiometer), and the controller may use data from the position sensor to determine a current state of the actuator 482 and / or the cam unit 476 (e.g., whether the cam unit 476 is in the first, second, or third position).
[0120] Based on the received sensor data, the controller can adjust the position of the cam unit 476 to control fluid flow into the container 404. For example, if the controller determines that the container 404 is more than full (e.g., the amount of fluid in the container 404 is above a threshold level), the controller can actuate the cam unit 476 to the second position, such that the elongated arm 478 blocks fluid flow into the container 404. Conversely, if the controller determines that the container 404 still has available space (e.g., the amount of fluid in the container 404 is below a threshold level), the controller can maintain the cam unit 476 in the first position, such that fluid can continue to flow into the container 404. The controller can adjust the status of the indicator light 492 to reflect the current status of the subassembly 424.
[0121] Referring again to FIG. 4B, in some embodiments, each subassembly 424a-424b includes a respective individual controller. In such embodiments, each controller may reside in any suitable location within the corresponding subassembly 424a-424b (e.g., within the upper section 428 or the lower section 430). However, in other embodiments, both subassemblies 424a-424b are operably coupled to a single controller. In such embodiments, the controller may reside in any suitable location within the flow control assembly 402 (e.g., mounted on or otherwise coupled to the frame 420). Alternatively, the controller may be remote from the flow control assembly 402, such as in the console 406 of the system 400 of FIG. 4A. Optionally, the controller may be the same as the controller 412 of the system 400 of FIG. 4A.
[0122] FIG. 5 is a flow diagram illustrating a method 500 of collecting urine from a patient according to an embodiment of the present technology. Method 500 may be performed by any of the embodiments of the systems and devices described herein, such as system 300 of FIG. 3 or system 400 of FIGS. 4A-4J. In some embodiments, some or all of the stages of method 500 are performed by a system or device including one or more processors and a memory storing instructions that, when executed by the processor, cause the system or device to perform one or more of the stages described herein. For example, method 500 may be performed by a flow control assembly (e.g., flow control assembly 302 of FIG. 3 or flow control assembly 402 of FIGS. 4A-4J) including or operably coupled to a controller (e.g., controller 312 of FIG. 3 or controller 412 of FIGS. 4A-4J). Optionally, some or all of the stages of method 500 may be performed automatically or semi-automatically by a suitable system or device with little or no human intervention.
[0123] Method 500 begins with detecting whether a first container is present at stage 505. The first container can be any container suitable for holding urine from a patient (first container 404a of system 400 of FIGS. 4A-4J). In some embodiments, stage 505 includes determining whether the first container is present and / or properly connected to the system based on sensor data. The sensor data can be generated by at least one sensor suitable for detecting the presence (e.g., location, proximity) of the first container, such as a location sensor (e.g., sensors 466 and / or 468 of system 400), an optical sensor, and an RFID sensor. The sensor can be part of and / or operably coupled to a flow control assembly for the first container, such as flow control assembly 402 of system 400. In some embodiments, the sensor is part of and / or operably coupled to an individual subassembly for the first container, such as first subassembly 424 of system 400.
[0124] Optionally, stage 505 may include detecting whether at least one second container is present (e.g., second container 404b of system 400 of FIGS. 4A-4J). Techniques for detecting the additional container may be the same or substantially similar to the techniques for detecting the first container. In addition, stage 505 may include additional processing to prepare the system for operation, such as priming one or more fluid lines connected to the containers. Example devices and techniques for priming fluid lines are described in more detail below with respect to FIGS. 7 and 8.
[0125] At stage 510, the method 500 continues with directing the urine flow into the first container. Stage 510 may include actuating a first valve operably coupled to the first container, so that urine and / or other fluids can flow into the first container. For example, the first container and the first valve may be connected to a first fluid line for receiving urine from a patient, and the first valve may be actuated to an open configuration to allow fluid to flow through the first fluid line. In some embodiments, stage 510 further includes locking the first container with a first retainer, so that the first container cannot be removed from the flow control assembly. This may advantageously prevent spillage or leakage caused by inadvertent removal of the first container during operation. The first valve and the first retainer may be or include any of the embodiments described above with reference to Figures 3-4J.
[0126] Optionally, stage 510 may include inhibiting urine flow into the second container, such as by actuating a second valve operably coupled to the second container to prevent fluid from flowing into the second container. For example, the second container and the second valve may be connected to a second fluid line for receiving urine from the patient, and the second valve may be actuated to a closed configuration to prevent fluid from flowing through the second fluid line. In such an embodiment, stage 510 may further include unlocking the second container from the second retainer, so that the second container may be removed from the flow control assembly. The second valve and the second retainer may be or include any of the embodiments described above with reference to Figures 3-4J.
[0127] At stage 520, method 500 includes measuring the amount of urine in the first container. The amount of urine may be quantified based on weight, volume, fluid level, and / or any other suitable parameter. Alternatively or in combination, stage 520 may include measuring the urine flow rate into the first container. The amount and / or flow rate of urine may be determined based on sensor data from any suitable sensor, such as any of the sensors described herein with reference to Figures 3-4J. In some embodiments, the amount and / or flow rate of urine is measured every second, every 5 seconds, every 10 seconds, every 30 seconds, every minute, every 2 minutes, every 5 minutes, every 10 minutes, or any other suitable period of time.
[0128] At stage 530, the method 500 continues with determining whether the amount of urine in the first container exceeds a threshold based on the measurements from stage 520. The threshold can be a value or range indicative of the first container being partially full or completely full. The threshold can correspond to a parameter (e.g., volume, weight, fluid level, etc.) of the first container when the first container is at least 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% full. For example, the threshold can be a weight value corresponding to 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% of the maximum weight of the first container (e.g., the weight of the first container when completely full). As another example, the threshold value may be a volume value corresponding to 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% of the maximum volume of fluid that the first container can hold. Optionally, the threshold value may vary based on the urine flow rate, for example, a lower threshold value for a higher urine flow rate and a higher threshold value for a lower urine flow rate.
[0129] If the amount of urine is less than or equal to the threshold, method 500 may return to stage 510 to continue the flow of urine into the first container. If the amount of urine exceeds the threshold, method 500 may proceed to stage 540 to determine whether a second container is available. For example, stage 540 may include detecting whether a second container is present using any of the techniques described above with respect to stage 505. Additionally, stage 540 may include measuring the amount of urine in the second container and determining whether the second container has space to hold urine based on sensor data from at least one sensor described above with respect to stage 520. For example, the second container may be considered "available" if the amount of urine therein is less than or equal to a threshold (e.g., a threshold corresponding to the volume, weight, and / or fluid level of the second container when the second container is at least 50%, 60%, 70%, 75%, 80%, 85%, 90%, 95%, 99%, or 100% full). In such embodiments, the threshold for the second container can be the same as the threshold for the first container, or can be a different threshold (e.g., a higher or lower threshold). As another example, the second container can be considered available if the amount of urine therein is less than the amount of urine in the first container. In yet another example, the second container can be considered available if it is not as full as the first container.
[0130] If a second container is available at stage 540, the method 500 can proceed to stage 550 and direct the urine flow into the second container. Stage 550 can include activating a second valve to open a second fluid line and allow fluid to flow into the second container. Optionally, stage 550 can include locking the second container with a second retainer so that the second container cannot be removed from the flow control assembly. The method 500 can then return to stage 510 as described above, except that it now includes monitoring the amount of urine in the second container instead of the first container.
[0131] In some embodiments, stage 550 further includes directing urine flow away from the first container, such as by activating a first valve to close the first fluid line and prevent fluid from entering the first container. The first container can be unlocked from the flow assembly by activating a first retainer, thereby allowing a user to remove, emptie, and / or replace the first container. Stage 550 can simultaneously or subsequently include alerting a user (e.g., by a light, sound, message, and / or other notification) that the first container is being emptied and / or replaced.
[0132] If at stage 540 the second container is unavailable (e.g., not present or too full), the method 500 may instead proceed to stage 560 and output a notification alerting the user that the first container is full or nearly full and that the user should either insert a second container into the system (if the second container is not present) or empty the second container (if the second container is present but too full). The notification may include any of the embodiments described herein, such as a light, a sound, a message displayed on a user interface, a message sent to a user device, or a suitable combination thereof. The method 500 may then return to stage 510 and proceed with directing the urine flow into the first container until the second container is available.
[0133] In some embodiments, some or all of the stages of method 500 are performed as part of a medical procedure on a patient. The medical procedure may be or include any diagnostic or treatment plan that includes monitoring the patient's urination. For example, the medical procedure may include treating the patient for a fluid overload condition (e.g., as described above with respect to FIGS. 1A and 2). Method 500 may be performed multiple times during a medical procedure to provide continuous or substantially continuous urination monitoring and / or collection. Thus, method 500 may advantageously reduce the number of times a medical professional must check the status of the container and / or empty the container during a medical procedure.
[0134] In some embodiments, the medical procedure is performed by a semi-automated or fully automated fluid management system (e.g., system 100 of FIG. 1A) and method 500 is performed by a flow control assembly included in or otherwise operably coupled to the system (e.g., flow control assembly 302 of FIG. 3 or flow control assembly 402 of FIGS. 4A-4J). In such embodiments, operation of the system can be coordinated with operation of the flow control assembly. For example, when the flow control assembly detects that one or both containers are present and ready for use (e.g., as described above at stage 505), the flow control assembly can send a signal to the system indicating that the medical procedure can begin (e.g., injecting a diuretic and / or rehydration fluid into the patient to induce urination). As another example, once the medical procedure is completed (e.g., the patient exhibits a desired amount of net fluid loss and / or a predetermined period of time has elapsed and / or the patient is disconnected from the urine collection system), the system can send a signal to the flow control assembly, which can automatically shut off fluid flow to both containers and optionally unlock both containers for removal.
[0135] Although method 500 has been described with respect to two containers, in other embodiments, method 500 can be modified to include a different number of containers (e.g., three, four, five, six or more containers). In such embodiments, method 500 can include directing the urine flow into one container at a time and switching to the next container when the previous container becomes full. Alternatively, method 500 can include directing the urine flow into multiple containers simultaneously and then individually shutting off the flow to each container when it becomes full.
[0136] 6A-6F illustrate a representative example of another urine collection system 600 ("system 600") configured in accordance with embodiments of the present technology. More specifically, FIG. 6A is a perspective view of system 600, and FIGS. 6B-6F are various views of a urine system 602 of system 600. System 600 may include at least some aspects substantially similar or identical in structure and / or function to one or more of the embodiments described herein (e.g., systems 100, 160, 170, 180 of FIGS. 1A-1D, system 300 of FIG. 3, and / or system 400 of FIG. 4A-4J), such as one or more of the components for monitoring and / or managing fluid levels described above with reference to FIG. 1A. Additionally or alternatively, any of the features of the embodiments of FIGS. 6A-6F may be combined with each other and / or with any of the other systems and devices described herein (e.g., system 100 of FIG. 1A and / or system 300 of FIG. 3).
[0137] 6A, system 600 includes a urine collection and monitoring system 602 ("urine system 602"), an automatic hydration fluid injection system 604 ("hydration system 604"), an automatic diuretic injection system 606 ("diuretic system 606"), a controller or control system 608 ("controller 608"), and a display or input / output unit 610 ("display 610"). Controller 608 may be operatively coupled to each of urine system 602, hydration system 604, diuretic system 606, and / or display 610. System 600 may further include a console or structure 605 ("console 605") that incorporates, contains, and / or otherwise supports all or a portion of urine system 602, hydration system 604, diuretic system 606, controller 608, and / or display 610. Similar to the embodiments described above, the urinary system 602 collects and monitors urine from the patient while the automatic rehydration fluid injection system 604 automatically delivers fluid to the patient and / or the automatic diuretic injection system 606 automatically delivers diuretic to the patient based in part on data obtained from the urinary system 602. For example, as described herein, the amount of diuretic and / or rehydration fluid provided to the patient is based on urine output from the patient as measured by the urinary system 602.
[0138] 6B and 6C are perspective views of a urinary system 602. The urinary system 602 can include a urinary cartridge 620 (FIG. 6B) and a urinary flow assembly 630. The urinary cartridge 620 and the urinary flow assembly may be referred to together as a flow control assembly. The urinary flow assembly 630 can include a container mounting component 632 ("mounting component 632"). In the illustrated embodiment, the mounting component 632 includes a connector (e.g., a hook) from which a container (e.g., container 112, FIGS. 1B-1D) can be suspended or supported. The mounting component 632 is movable between a first, unpressurized position and a second, pressurized position when the mounting component 632 supports a weight of the container. Thus, when in the second position but not in the first position, the mounting component 632 can indicate the presence of a container thereon. When in the second position, the mounting component 632 can engage components of the urinary flow assembly 630, for example, by activating one or more sensors to monitor and / or determine the patient's urination rate. 6B and 6C, the urine cartridge 620 and / or urine flow assembly 630 can be positioned at least partially within a chamber or recessed area 607 defined in part by the console 605. For example, the mounting component 632 and a receptacle (not shown) hanging therefrom can reside in the recessed area 607, which can reside behind a door to limit the possibility of physically disturbing the receptacle and / or mounting component 632.
[0139] The urine cartridge 620 can be releasably coupled to the system 602. For example, the urine system 602 can include one or more receiving features 609 (shown with reference numbers 609a and 609b) configured to receive the urine cartridge 620. In the illustrated embodiment, the urine system 602 includes a pivot receiving feature 609a and a slot receiving feature 609b that together can couple the urine cartridge 620 to the urine system 602. As shown in FIG. 6B, with the urine cartridge 620 omitted for illustrative purposes, the pivot receiving feature 609a can pivotally engage the urine cartridge 620 such that the urine cartridge 620 can pivot toward and / or at least partially into the slot receiving feature 609b. As described elsewhere herein (e.g., with reference to FIGS. 6D-6F), the urine cartridge 620 can include tubing configured to direct urine from the patient to a container, and when coupled to the system 602, the urine cartridge 620 can position and direct the tubing relative to the phase of the urine flow assembly 630 to enable urine flow measurements and provide urination (e.g., average urination rate). In some embodiments, the tubing is coupled (e.g., glued) to the urine cartridge 620 before the urine cartridge 620 is attached to the console 605 at the receiving feature 609.
[0140] FIG 6D is a partial schematic cross-sectional perspective view of the urinary system 602 taken along line 6D-6D in FIG 6C. As shown in FIG 6D, fluid F (e.g., urine) from a patient P can flow through a portion of the urinary system 602 through one or more fluid lines (fluid line 119, FIG 1B-1D) and into a container 612 (e.g., container 112, FIG 1B-1D). The urinary flow assembly 630 can include one or more fluid sensors operable to measure and / or determine the flow of the fluid F through the urinary system 602. As shown in FIG 6D, the urinary flow assembly 630 includes a first fluid sensor 634 (e.g., second sensor 114b, FIG 1B) and a second fluid sensor 636 (e.g., first sensor 114a, FIG 1B). The first sensor 634 may include a load cell and be configured to measure or generate (e.g., continuously) first sensor data including the weight of the container 612 when coupled to the mounting component 632. The first sensor data (e.g., the weight of the container 612 and / or changes therein) may be used to generate a first patient output (e.g., an average volumetric flow rate). The second sensor 636 may include a flow sensor and be configured to measure or generate (e.g., continuously) second sensor data including the flow of fluid F through the fluid line. The second sensor data may be used to generate a second patient output (e.g., an average volumetric flow rate).
[0141] The urinary system 602 may further include one or more flow control devices 638 (e.g., flow control device 138 of FIG. 1B). The flow control device 638 may include a pinch clamp or pinch valve configured to fully or at least partially regulate the fluid flow through the system 602, such as when priming one or more of the fluid lines. The flow control device 638 may be used to control the flow based on first sensor data from the first sensor 634 or by user input when the system 602 determines that the weight of the container 612 is decreasing. In such an embodiment, the flow control device 638 may only control the flow when the second sensor 636 is disabled or inactive and only the first sensor 634 is active. While the flow control device 638 is closed and there is no flow to the container 612, patient output is not measured. However, in such an embodiment, the rate and / or volume of urination may be calculated or estimated based on the time of no flow and flow measurements obtained when flow resumes. The flow control device 638 can regulate fluid flow by externally constricting the fluid line without contacting the fluid. Alternatively, the flow control device 638 can be a gate, needle, or other type of valve that can regulate fluid flow by contacting the fluid. Priming of the fluid lines is discussed in more detail herein, for example, with reference to Figures 9A-14B. In the illustrated embodiment, the flow control device 638 is located upstream of the flow sensor 636. In other embodiments, the flow control device 638 can be positioned downstream of the flow sensor 636 and / or have any other suitable location.
[0142] 6E and 6F are partial schematic cross-sectional side views of the urine system 602, with FIG. 6E showing where an upper portion 622a of the urine cartridge 620 engages the console 605, and FIG. 6F showing where an upper portion 622a and a lower portion 622b of the urine cartridge 620 engage the console 605. As described in more detail with reference to FIG. 6H, the lower portion 622b can be fixedly attached to the console 605, for example, by snapping into a corresponding feature of the console 605. For illustrative purposes, the fluid line (e.g., fluid line 619 in FIGS. 6G and 6H) has been omitted from FIGS. 6E and 6F, but as described herein, the fluid line 619 can extend through the urine cartridge 620 and a portion of the flow control device 638 such that it is positioned adjacent to the second sensor 636.
[0143] As shown in Figures 6E and 6F, the system 602 may further include one or more detection sensors 635. In some embodiments, the one or more sensors 635 are optical blocking sensors including an emitter that emits an infrared beam and a receiver positioned to receive the beam. When the urine cartridge 620 is properly coupled to the console 605, the beam is blocked and not received by the receiver. Thus, the system 602 or controller may generate a signal indicating that the urine cartridge 620 is present and / or properly positioned, and thus, that the fluid line is properly positioned relative to the second sensor 636. As shown in Figures 6D and 6E, the one or more sensors 635 are positioned adjacent (e.g., below) the second sensor 636, although in other embodiments, the one or more sensors 635 may be positioned elsewhere on the console 605 or the system 602. In some embodiments, the one or more sensors 635 may be a mechanical switch movable between a first position and a second position that indicates the presence and / or correct positioning of the urine cartridge 620.
[0144] FIG. 6G is a perspective view of a urine cartridge 620 and a urine flow assembly 630. The urine cartridge 620 can be configured to receive a fluid line 619 (e.g., fluid line 119, FIGS. 1B-1D). The fluid line 619 can fluidly couple a patient P (FIG. 6D) with a container 612 (FIG. 6D) through a catheter (e.g., catheter 118, FIG. 1B). As shown in FIG. 6G, the flow sensor 636 can include a groove 637 (e.g., a U-shaped groove) that at least partially defines a slot or channel 640 ("slot 640") that receives the fluid line 619. Further, the slot 640 is defined by a portion of the urine cartridge 620 on an opposing side. When the urine cartridge 620 is coupled to the system 602 and / or console 605 (FIGS. 6B and 6C), the urine cartridge 620 and the flow sensor 636 can position and / or orient the fluid line 619 within the slot 640 to ensure accurate and reliable flow measurements. In the illustrated embodiment, for example, the urine cartridge 620 can be configured to press and / or hold the fluid line 601 against the flow sensor 636, which can improve the accuracy of urination measured by the flow sensor 636.
[0145] As shown in FIG. 6G, the flow control device 638 can include a slot or groove 639 configured to receive the fluid line 619. The slot 639 can allow the fluid line 619 to be coupled to the urine cartridge 620 before the urine cartridge 620 is coupled to the console 605 (FIG. 6E) or to the remainder of the system 602. The fluid line 619 can be coupled (e.g., glued) to a portion of the urine cartridge 620 (FIGS. 6B and 6C) that can be removably attached to the console 605 as described above. In making this coupling, the position and orientation of the fluid line 619 in the slot 640 can be set (e.g., without the involvement of a user or medical personnel) before the urine cartridge 620 is coupled to the console 605, for example, to ensure a more accurate flow measurement by the flow sensor 636. Additionally or alternatively, in making this setting, the length of the fluid line 619 extending from the urine cartridge to the container 612 (FIG. 6D) can be set to an appropriate length that can also ensure a more accurate flow measurement by the flow sensor 636. In other words, if the fluid line 619 is not properly set in the slot 640 or if the length of the fluid line 619 extending from the urine cartridge 620 to the container 612 is improper (e.g., too short), it may cause the flow measurement by the flow sensor 636 to be less accurate and / or less consistent between measurements. For example, if the fluid line 619 extending from the urine cartridge 620 to the container 612 is too short, the container 612 may apply additional pressure against the urine cartridge and / or physically dislodge the urine cartridge, which may affect the flow measurement by the flow sensor 636. Furthermore, if the fluid line 619 extending from the urine cartridge 620 to the container 612 is too short, the container 612 may be pulled by the tubing 619, which may alter the weight reading of the container 612 by the first sensor 634, resulting in an inaccurate measurement of the rate or volume of fluid flow into the container 612.
[0146] The operation of the urinary system 602 may be substantially similar to the operation of other systems described herein, such as the FIG. 1B fluid management system 160. As fluid F flows through the system 602 and into the container 612, the weight of the container 612 increases. Thus, the weight sensor 634 measures the amount of fluid F accumulated in the container 612 by measuring the weight of the container 612, from which a urine output rate from the patient can be generated. At any point when the container 612 is full or greater than a predetermined threshold, the fluid F can be drained or otherwise removed from the container 612 (e.g., through the drain valve 113 of FIG. 1B). When the container 612 is being drained, the weight of the container 612 is expected to decrease or increase at a slower rate than expected as the container 612 is still picking up fluid F during drainage. Additionally or alternatively, the container 612 can be replaced with another container.
[0147] The weight sensor 634 may not provide as accurate urination measurements when the container 612 is being replaced and / or emptied. However, during these times, the flow sensor 636, which may operate independently of the weight and / or presence of the container 612, may continue to measure the patient's urination, and thus the system 600 (FIG. 6A) may continue to administer therapy while the container 612 is being replaced and / or emptied. In some embodiments, for example, the urinary system 602 may detect a decrease in the weight of the container 612 associated with replacing and / or emptying the container 612, and switch accordingly to measuring the patient's urination using the flow sensor 636. The urinary system 602 may revert to using the weight sensor 634 upon detecting an increase in weight associated with fluid collection into the container 612 or replacement of the container 612. Additionally or alternatively, the urinary system 602 may use both the weight sensor 634 and the flow sensor 636 to measure the patient's urination before, during, and / or after the container 612 is emptied and / or replaced, and / or may compare the measurements of both sensors 634, 636 as described in detail above with reference to Figure 1B to ensure accuracy. In some embodiments, either the weight sensor 632 or the flow sensor 636 may be omitted.
[0148] FIG. 6H is a perspective view of a urine cartridge 620. The urine cartridge 620 can include a body 622 having a first end or top portion 622a and an opposing second end or bottom portion 622b. The first end portion 622a can include a first urine system coupling feature 624a ("first coupling feature 624a") and the second end portion 622b can include a second urine system coupling feature 624b ("second coupling feature 624b"). The first coupling feature 624a and the second coupling feature 624b can ensure precise alignment of the fluid line 619 relative to the flow sensor 636 (FIG. 6G). In the illustrated embodiment, the first mating feature 624a can be pivoted to be received by the pivoting receiving feature 609a (FIGS. 6B and 6C), and the second mating feature 624b can be inserted into a correspondingly shaped recess (not shown) in the console 605 (FIGS. 6B and 6C). The second mating feature 624b can include a tab having a flared, enlarged end or other shape. For example, in some embodiments as shown in FIG. 7, the urine cartridge 620 can include a mating feature 624b having a plurality of vertically aligned tabs or any other suitable configuration.
[0149] Referring again to FIG. 6H, the urine cartridge 620 may further include one or more ports or openings 626a-626c (together referred to as "ports 626") into which the fluid line 619 is inserted. In other words, the ports 626 define a path for the fluid F to flow from the patient to the container. The urine cartridge 620 may include a sensing region 629 that at least partially defines a slot 640 (FIGS. 6D and 6G), and a fluid line engagement feature 628 ("engagement feature 628") configured to engage or abut the fluid line with the urine flow assembly 630. As described above (e.g., with reference to FIG. 6G), the urine cartridge 620 may partially position and / or orient the fluid line 619 within the slot 640 to ensure accurate and consistent flow measurements. In the illustrated embodiment, the engagement feature 628 includes a protrusion or tab extending from the body 622 to limit bending or undesired orientation of the fluid line 619 at the sensing region 629. In some embodiments, engagement feature 628 may have different configurations and structures and / or may be positioned between openings 626b and 626c.
[0150] FIG. 8 is a flow diagram illustrating a method 800 of collecting urine from a patient according to an embodiment of the present technology. Method 800 may be performed by embodiments of systems and devices described herein, such as system 160 of FIG. 1B or system 600 of FIGS. 6A-7. In some embodiments, some or all of the stages of method 800 are performed by a system or device including one or more processors and a memory storing instructions that, when executed by the processor, cause the system or device to perform one or more of the stages described herein. For example, method 800 may be performed by a urine system (e.g., system 602 of FIGS. 6A-6G) including or operably coupled to a controller (e.g., controller 608 of FIG. 6A). Optionally, some or all of the stages of method 800 may be performed automatically or semi-automatically by a suitable system or device with little or no human intervention. At least some stages of method 800 may be substantially similar or identical to one or more stages of method 200 of FIG. 2 and / or method 500 of FIG. 5.
[0151] The method 800 begins at stage 810 with measuring first sensor data including a weight of a container (e.g., container 112 of FIG. 1B or container 612 of FIG. 6D) by a first sensor (e.g., second sensor 114b of FIG. 1B or weight sensor 634 of FIG. 6D-6G). The first sensor measurement may be performed continuously at a specific interval (e.g., every 1 second, every 10 seconds, every 30 seconds, every minute, etc.). In some embodiments, the method 800 may include detecting the presence of the container (e.g., by the first sensor) before measuring the weight of the container. In some embodiments, the method 800 may further include directing urine from the patient to the container through a flow control assembly. The flow control assembly may correspond to the system 602 (FIGS. 6A-6G) or aspects thereof, such as the fluid line 619, the urine cartridge 620, the flow control device 638.
[0152] The method 800 further includes generating a first patient output via a first sensor at stage 820. The first patient output may be an average urine flow rate (e.g., volumetric flow rate) over the last 30 seconds, 1 minute, 2 minutes, or more interval and may be updated on a recurring basis. The first patient output may be based on a change in weight of the container. As described herein (e.g., with reference to FIGS. 1B and 6A-6H), the first patient output may be used as a primary input or source of information used to deliver therapy to the patient. For example, the first patient output may be used to at least partially determine the amount of diuretic and / or rehydration fluid delivered to the patient.
[0153] The method 800 further includes a stage 830 of determining that the weight of the container is decreasing. As described herein (e.g., with reference to FIG. 1B and FIG. 6A-6H), the container can be drained through a drain valve (e.g., drain valve 113, FIG. 1B) while remaining fluidly coupled to the patient and / or without being removed from the corresponding system or console. In such an embodiment, draining the container may reduce the weight of the container or increase at a slower rate than expected since the container 612 is still collecting fluid during draining. A decreasing weight of the container or a slower rate of increase may, for example, discontinue using the first urination as a primary source of information for determining the amount of diuretic and / or rehydration fluid delivered to the patient. In some embodiments, a decreasing container weight or a slower rate of increase may maintain or reduce the current amount of diuretic and / or rehydration fluid delivered to the patient.
[0154] The method 800 further includes measuring second sensor data by a second sensor (e.g., the first sensor 114a of FIG. 1B or the flow sensor 636 of FIGS. 6D-6G) including a second patient urination. The second sensor measurements may be taken continuously at a particular interval (e.g., every second, every 10 seconds, every 30 seconds, every minute, etc.). The second patient urination may be an average urine flow rate (e.g., volumetric flow rate) over the last 30 seconds, 1 minute, 2 minutes, or more, and may be updated on a recurring basis.
[0155] The step of measuring the second sensor data may occur at all times, including before, during, and after the step of determining that the weight of the container is decreasing. As described herein (e.g., with reference to FIG. 1B and FIG. 6A-6H), in some embodiments, the first patient urination determined through the first sensor data may be used as a primary input or information source used to deliver therapy to the patient, but may be inaccurate at times, for example, when the container is being drained. In such embodiments, the second patient urination determined through the second sensor data may be utilized as the primary information source. Additionally or alternatively, the second patient urination may be used if the difference between the first patient urination and the second patient urination is at or greater than a predetermined threshold (e.g., a difference of 5%, 10%, 20%, or 30%). The second patient urination may remain as the primary information source until another condition is satisfied or an event occurs. Such conditions or events may include determining an increase in the weight of the container, which may indicate that the container is no longer draining, or may include an elapsed time (e.g., 10 seconds, 30 seconds, or 1 minute) after determining that the weight of the container is increasing.
[0156] In some embodiments, some or all of the stages of method 800 are performed as part of a medical procedure on a patient. For example, the medical procedure may include treating a patient for a fluid overload condition (e.g., as described above with respect to FIGS. 1A and 2). Method 800 may be performed multiple times during a medical procedure to provide continuous or substantially continuous urine output monitoring and / or collection. Thus, method 800 may advantageously reduce the number of times a medical professional must check the status of the container and / or empty the container during a medical procedure.
[0157] In some embodiments, the medical procedure is performed by a semi-automated or fully automated fluid management system (e.g., system 100 of FIG. 1A) and method 800 is performed by a urine collection and monitoring system (e.g., system 602 of FIGS. 6A-6G) included in or otherwise operably coupled to the system. In such embodiments, the operation of the system and the urinary system may be coordinated. For example, when the urinary system detects that a container is present and ready for use (e.g., as described above in stage 810), the urinary system may send a signal to the system indicating that the medical procedure may begin (e.g., injecting a diuretic and / or rehydration fluid into the patient to induce urination). As another example, when the urinary system detects that urine is being drained from the container (stage 850), the system may send a signal to the urinary system to cause the urinary system to switch to a second sensor (stage 860). As an additional example, once the medical procedure is completed (e.g., the patient exhibits a desired amount of net fluid loss and / or a predetermined period of time has elapsed and / or the patient is disconnected from the urine collection system), the system can send a signal to the urinary system, which can automatically shut off fluid flow to the container.
[0158] While method 800 has been described with respect to one container and two sensors, in other embodiments, method 800 can be modified to accommodate a different number of containers (e.g., 2, 3, 4, 5, or more than 6 containers) and / or sensors (e.g., 3, 4, 5, or more than 6 sensors). In such embodiments, method 800 can include directing the urine flow into one container at a time and switching to the next container when the previous container is full. Alternatively, method 800 can include directing the urine flow into multiple containers simultaneously and then individually shutting off the flow to each container when each container is full. In these and other embodiments, method 800 can include selectively activating and / or deactivating one or more individual sensors when urine is detected flowing out of the container.
[0159] B. Devices for priming and / or removing obstructions In some embodiments, the urine collection systems and devices described herein use relatively small fluid lines in receiving urine from the patient. For example, any of the fluid lines described herein can have an inner diameter less than or equal to 0.5 inches, 0.375 inches, 0.25 inches, 0.125 inches, or 0.1 inches. Smaller fluid lines can be advantageous in maintaining a continuous or substantially continuous fluid column or volume of urine from the patient's body to the urine container (e.g., a fluid column or volume of urine with few or no gaps, air bubbles, etc. between the bladder and the container). This method can improve the accuracy of the urination monitor by ensuring that weight and / or volume changes in the container closely track the patient's actual urine production.
[0160] However, smaller fluid lines may be susceptible to air locks and / or other blockages that impede or otherwise block urine flow. Air locks may also occur if air is introduced into the flow line before and / or during a urine collection procedure. For example, the fluid line may first be primed with saline or another fluid before being connected to the patient's body. If the user does not fasten the fluid line when connecting it to the patient's body (e.g., through the catheter), saline may flow prematurely into the container, thereby introducing air into the fluid line. As another example, if the catheter is not primed with fluid when connected into the patient's body, air within the lumen of the catheter may flow into the fluid line. The presence of air in the fluid line may result in an air lock that partially or completely impedes urine flow from the patient's body into the container. The obstructed urine flow may result in a drop in the measured urination rate that does not accurately reflect the patient's actual urination rate. In addition, when the obstruction is removed, urine that has accumulated in the patient's bladder and / or fluid lines may be released in a large bolus, resulting in an artificially high measured urination rate. These scenarios may interfere with monitoring urination and / or managing fluid levels in accordance with the processes of the inventive techniques described herein.
[0161] FIG. 9A illustrates an example of an air lock in a conventional urine collection system 900. The system 900 is coupled to a catheter 902 (e.g., a Foley catheter) that is connected to a patient's body (not shown). The system 900 includes a fluid line 904 coupled to the catheter 902 and a container 906 (e.g., a bag) coupled thereto. In the illustrated embodiment, urine 908 from the patient is present within the catheter 902 and a portion of the fluid line 904 (shown hatched in FIG. 9A). The fluid line 904 includes a high region 912 between the catheter 902 and the container 906 that blocks urine flow beyond it until there is sufficient internal pressure in the fluid line 904 to push the urine 908 beyond it, so that the remainder of the fluid line 904 is filled with air 910. As the urine 908 passes the high region 912, this region creates a siphon that continues to draw fluid from the patient's body.
[0162] FIG 9B illustrates another example of an air lock in a urine collection system 900. In FIG 9B, the fluid line 904 includes a loop 914 between the catheter 902 and the container 906. A volume of urine 908 at the bottom of the loop 914 is trapped, and the remainder of the loop is filled with air 910. This means that the urine 908 cannot flow into the container 906 until there is enough internal pressure in the fluid line 904 to push the air 910 and the trapped urine 908 out of the loop 914. The pressure required may cause discomfort to the patient and / or cause urine to leak around the catheter 902.
[0163] To address these and / or other challenges, the urine collection systems described herein may include a device (also referred to herein as a "pumping device" or "priming device") for removing air locks from the fluid lines and / or priming the fluid lines with fluid (e.g., urine or saline). In some embodiments, the pumping device is placed in-line with the fluid line rather than being a separate component attached to the fluid line. This method may reduce the risk of infection by allowing the pumping device to be sterilized along with the fluid line and / or other urine collection components (e.g., catheter, container, etc.).
[0164] 10 is a schematic diagram of a urine collection system 1000 including a pumping device 1002 configured in accordance with an embodiment of the present technology. The system 1000 is configured to be coupled to a catheter 1004 (e.g., a Foley catheter) that can be connected to a patient's body (not shown). The system 1000 includes a container 1006 (e.g., a bag), a first fluid line 1008a that fluidly couples the catheter 1004 to the pumping device 1002, and a second fluid line 1006b that fluidly couples the pumping device 1002 to the container 1008. The pumping device 1002 is disposed in series with the first and second fluid lines 1008a, 1008b and is between the catheter 1004 and the container 1006. In some embodiments, the pumping device 1002 is positioned closer towards the container 1006 than the catheter 1004, which may reduce the likelihood that the pumping device 1002 may catch on the patient's clothing and / or body and apply forces to the catheter 1004 that may cut the catheter 1004 and / or cause patient discomfort. For example, the length of the second fluid line 1008b between the pumping device 1002 and the container 1006 may be less than or equal to 100 cm, 50 cm, 40 cm, 30 cm, 20 cm, 10 cm, or 5 cm.
[0165] The pumping device 1002 may be a hollow structure or member including a lumen suitable for fluid flow (such as, for example, urine, saline, air). In the illustrated embodiment, the pumping device 1002 includes a first end portion 1010a connected to a first fluid line 1008a, a second end portion 1010b connected to a second fluid line 1008b, and a flexible body portion 1012 between the first end portion 1010a and the second end portion 1010b. The flexible body portion 1012 may be a deformable valve, balloon, chamber, etc. made of a resilient material (e.g., a polymeric material and / or an elastomeric material). The flexible body portion 1012 may be actuable between a relaxed and / or unloaded configuration and a loaded configuration. In some embodiments, the flexible body portion 1012 is actuated multiple times to gradually pump fluid from the first fluid line 1008a through the pumping device 1002 and into the second fluid line 1008b. For example, the flexible body portion 1012 can be manually compressed by a user (e.g., by squeezing with a hand), compressed by an actuator 1013 (e.g., a servo motor or other electromechanical device), or a suitable combination thereof.
[0166] In some embodiments, the pumping device 1002 is configured to allow fluid flow in a single direction, for example, from the first fluid line 1008a into the first end portion 1010a and from the second end portion 1010b into the second fluid line 1008b, as shown in Fig. 10 in the direction D5. The pumping device 1002 can inhibit fluid flow in the opposite direction, for example, from the second fluid line 1008b into the second end portion 1010b and / or from the first end portion 1010a into the first fluid line 1008a. This unidirectional flow can reduce or prevent backflow of fluid toward the patient's body, protecting the patient from infection.
[0167] For example, in the FIG. 10 embodiment, a first end portion 1010a of the pumping device 1002 includes a first (e.g., proximal) valve 1014a, and a second end portion 1010b of the pumping device 1002 includes a second valve 1014b. The first valve 1014a can permit fluid flow from the first fluid line 1008a into the flexible body portion 1012, while inhibiting fluid flow from the flexible body portion 1012 into the first fluid line 1008a. Similarly, the second valve 1014b can permit fluid flow from the flexible body portion 1012 into the second fluid line 1008b, and inhibit fluid flow from the second fluid line 1008b into the flexible body portion 1012. Each of the first and second valves 1014a-1014b can be or include a check valve or other one-way flow mechanism. Examples of check valves include, but are not limited to, ball check valves (e.g., ball cage check valves), swing check valves, diaphragm check valves, lift check valves, duckbill check valves, and the like. In some embodiments, the first and second valves 1014a-1014b have little or no "crack pressure" (pressure to open the valves in the forward flow direction), and thus urine and / or other fluids can flow freely through the pumping device 1002 along direction D5 when the pumping device 1002 is not actuated. This can avoid problems associated with fluid accumulation in the bladder due to insufficient fluid pressure to open the valves.
[0168] When the flexible body portion 1012 is compressed, pressure within the flexible body portion 1012 increases, which can cause the first valve 1014a to close and the second valve 1014b to open. Thus, fluid (such as, for example, air, urine, saline) can be pushed forward from the flexible body portion 1012 into the second fluid line 1008b and / or from the second fluid line 1008b into the container 1006. In the illustrated embodiment, the second end portion 1010b is higher than the first end portion 1010a, so any air within the flexible body portion 1012 will rise to the top and therefore be the first to be displaced when the flexible body portion 1012 is compressed. When the flexible body portion 1012 is released, the resiliency of the flexible body portion 1012 can cause the flexible body portion 1012 to return towards its relaxed configuration, thereby reducing the pressure within the flexible body portion 1012. The pressure drop can cause the second valve 1014b to close and the first valve 1014a to open. This pressure drop can create a vacuum that draws fluid from the first fluid line 1008a up through the first end portion 1010a and into the flexible body portion 1012. In some embodiments, little or no air outside the patient's body is drawn into the first and second fluid lines 1008a-1008b, the pumping device 1002, the container 1006, and / or the catheter 1004 throughout the actuation process, thus allowing the system 1000 to remain in a closed state, reducing the risk of infection.
[0169] The actuation process described herein can be repeated multiple times to gradually pump fluid through the first and second fluid lines 1008a-b toward the container 1006. For example, the actuation process can be performed at the beginning of a medical procedure to prime the system 1000 by drawing urine from the patient's bladder into the container 1006, thereby generating a continuous column or volume of urine from the patient's body to the container 1006. The continuous column of urine can generate a siphon that actively draws urine from the patient's body, thereby reducing or eliminating any wasted volume in the bladder. The siphon can ensure that there is little or no delay between when urine is produced in the patient's body and when the urine reaches the container 1006, thereby improving the accuracy of the urine monitor technology described herein. Optionally, the flexible body portion 1012 can remain in a compressed configuration due to its compliant nature when the patient's bladder is empty or substantially empty after the flexible body portion 1012 is crushed. This can reduce or minimize the sustained vacuum against the patient's bladder, thereby reducing the possibility of aspiration trauma caused by the catheter entrance sucking against the bladder wall.
[0170] As another example, the actuation process can be performed to clear air locks and / or other obstructions from the first and / or second fluid lines 1008a-1008b during a medical procedure. In some embodiments, repeated actuation of the pumping device 1002 can push trapped air from the first and / or second fluid lines 1008a-1008b into the container 1006. Similar to the priming process described above, repeated actuation can draw urine from the patient's bladder through the first and / or second fluid lines 1008a-1008b to generate a continuous column of urine throughout the system 1000.
[0171] In yet another example, the pumping device 1002 can be used to diagnose potential problems within the system 1000. For example, if the flexible body portion 1012 collapses but does not automatically re-expand and fill with urine, this can indicate one or more of the following conditions: (1) one or more components inside or outside the patient's body (e.g., the catheter 1004, the first fluid line 1008a, the second fluid line 1008b) are kinked, (2) the catheter 1004 is against the bladder wall or is otherwise unable to draw fluid from the bladder, (3) there is a clog in the catheter 1004, the first fluid line 1008a, and / or the second fluid line 1008b, and / or (4) the patient's bladder is empty.
[0172] In some embodiments, a user (e.g., a nurse or other medical personnel) manually activates the pumping device 1002 to prime the system 1000 with fluid and / or to clear an air lock from the system 1000. However, in other embodiments, activation can be performed automatically or semi-automatically by an actuator 1013 coupled to the pumping device 1002. The actuator 1013 can be operably coupled to a controller 1015 (e.g., controller 140 of the system 100 of FIG. 1A) and / or a urine collection system (e.g., system 300 of FIG. 3, system 400 of FIGS. 4A-4J, and / or system 600 of FIGS. 6A-6G). For example, during a set-up process for a medical procedure (e.g., a procedure to treat fluid overload), the controller 1015 can actuate the actuator 1013 to operate the pumping device 1002 to prime the first and second fluid lines 1008a-1008b with fluid. Priming can be performed in response to an appropriate signal, such as a user input indicating that the first and second fluid lines 1008a-b are connected to the patient's body through the catheter 1004. As another example, during a medical procedure, the controller 1015 can detect whether an air lock or other obstruction is present (e.g., based on sensor data indicating an unexpected drop in urination rate and / or other appropriate indicators) and can operate the pumping device 1002 until the air lock is cleared (e.g., based on sensor data indicating urinary output has resumed). Additionally, the controller 1015 can operate the pumping device 1002 to maintain urine flow through the first and second fluid lines 1008a-b during the procedure.
[0173] FIG. 11 is a perspective view of a priming valve 1102 configured in accordance with an embodiment of the present technology. The priming valve 1102 can serve as a pumping device 1002 in the FIG. 10 system 1000. As shown in FIG. 11, the priming valve 1102 includes a first end portion 1110a including a first check valve (not shown), a second end portion 1110b including a second check valve (not shown), and a flexible body portion 1112 between the first end portion 1110a and the second end portion 1110b. The flexible body portion 1112 can have a round shape suitable for being crushed by hand and / or an actuator. Optionally, the flexible body portion 1112 can be transparent or translucent to allow a user to visualize the amount of fluid therein. In some embodiments, the size of the priming valve 1102 is large enough so that the priming valve 1102 can pump fluid with a relatively small number of compressions (e.g., less than 10, 5, 4, 3, or 2 compressions), but not so large that an excessive amount of force is required to compress the priming valve 1102. For example, the internal volume of the priming valve 1102 can be in the range of 10 ml to 50 ml, or in the range of 20 ml to 30 ml.
[0174] Referring again to FIG. 10, alternatively or additionally, the system 1000 can use other types of pumping devices, such as peristaltic pumps and syringe pumps, to prime the first and second fluid lines 1008a-b and / or to remove air locks. For example, in other embodiments, it is contemplated that a T-fitting can be installed between the first and second fluid lines 1008a-b with a check valve between each end of the T-fitting and the corresponding fluid line. The check valve can be oriented to allow fluid flow from the patient's body to the container 1006 while restricting fluid flow in the opposite direction (e.g., similar to the first and second valves 1014a-b). A syringe mechanism can be connected to the third leg of the T-fitting. The syringe mechanism can be retracted to generate a vacuum that draws fluid from the bladder into the first fluid line 1008a and / or the syringe body. The syringe mechanism can then be pushed to force fluid from the syringe body and / or second fluid line 1008b into the container 1006. This process can be repeated to remove air locks and / or generate a urine cast for proper flow. Optionally, the syringe mechanism can then be disconnected from the T-fitting and the third leg of the T-fitting can be occluded with a stopcock or other sealing element. Alternatively, the third leg can include a needleless luer connector or other element that automatically seals when the syringe mechanism is removed.
[0175] In some embodiments, catheters supplied by manufacturers are pre-connected to a urine drainage line and container, which may make priming the entire plumbing system associated with the catheter more difficult. Some embodiments of the present technology include systems, devices, and methods for priming such systems. FIG. 12, for example, shows a schematic urine collection system 1200 in accordance with an embodiment of the present technology. As shown in FIG. 12, system 1200 can include a device 1205 (e.g., a cartridge) configured to be fluidly coupled to a fluid source 122 through fluid line 129 (described above with reference to FIG. 1A ) and to a catheter 118 through fluid line 119 (described above with reference to FIG. 1A ). The device 1205 can include (i) a coupler 1210 (e.g., a T-fitting), (ii) a first supply line 1220 fluidly coupled to a first inlet of the coupler 1210, the first supply line 1220 including a valve 1222 disposed between the coupler 1210 and the catheter 118 and configured to regulate fluid from the catheter 118, and (iii) a second supply line 1230 fluidly coupled to a second inlet of the coupler 1210, the second supply line 1230 including a port 1232 (e.g., a luer connector or a needleless luer connector) configured to be fluidly coupled to a fluid source 122 and optionally including a valve 1234 (e.g., a check valve) disposed between the port 1232 and the coupler 1210. The port 1232 can be configured to prevent any fluid outflow from the second supply line 1230 when disconnected from the fluid line 129 and / or the fluid source 122. The valve 1234 can be configured to prevent any backflow of fluid into the fluid line 129 and / or the fluid source 122. The device 1205 can further include an outlet line 1240 fluidly coupled to an outlet of the coupler 1210. The outlet line 1240 can include a connector 1242 having a first end fluidly coupled to a valve 1246 and a first container 1250 downstream thereof, and a second end fluidly coupled to a valve 1248 and a second container 1252 downstream thereof.System 1200 and / or device 1205 may further include a controller 1260 operably coupled to at least valves 1222, 1246, 1248 and thus configured to regulate fluid flow through device 1205. Controller 1260 may be the same as or similar to controller 140 described elsewhere herein.
[0176] The system 1200 can be used to prime the device 1205 with fluid (e.g., saline) from the fluid source 122, thereby removing air from the system 1200. By doing so, the system 1200 maintains a continuous or substantially continuous fluid column or volume of urine from the patient's body to the container 1250, 1252 (e.g., a fluid column or volume with few or no gaps, air bubbles, etc. between the bladder and the container). As discussed above, this method can improve the accuracy of the urination monitor by ensuring that the weight and / or volume changes in the container 1250, 1252 closely track the patient's actual urine production. In addition to this, when the catheter 118 is connected to the patient, the fluid column created by priming can induce a vacuum or negative pressure (e.g., less than or equal to 0.5 psi) in the bladder. This vacuum or negative pressure can improve the removal of urine from the bladder and / or stimulate additional urine production.
[0177] In operation, fluid from the fluid source 122 can be pumped into the device 905 to remove air in the first supply line 1220, the second supply line 1230, and the outlet line 1240. For example, one method of priming the system 1200 can include closing the valves 1222, 1246, 1248, and fluidly coupling the fluid source 122 to the coupler 910 through the fluid line 129, the port 932, and the valve 1234. The valves 1246, 1248, and 1250 can then be individually opened and closed to allow fluid flow through the valves to purge the air. For example, after injecting fluid from a fluid source through port 1232 and valve 1234, (i) valve 1246 can be opened and then closed after the line between connector 1242 and container 1250 is filled with fluid, (ii) valve 1248 can be opened and then closed after the line between connector 1242 and container 1252 is filled with fluid, and (iii) valve 1222 can be opened to allow fluid to flow from coupler 1210 through valve 1222 and fluid line 119 to catheter 118 and then closed after the line between valve 1222 and catheter 118 is filled with fluid. The above-described method can be performed manually by a user or automatically by controller 1260. Once priming is complete, catheter 118 can be inserted into the patient. Advantageously, by priming the system 1200 prior to connecting the catheter 118 to the patient, embodiments of the present technology can reduce the likelihood of catheter-associated urinary tract infections (CAUTIs) compared to systems that do not or cannot be primed in the manner described herein.
[0178] 13 illustrates another example of a schematic urine collection system 1300 in accordance with an embodiment of the present technology. System 1300 includes a device 1305 that has many of the same features and functions as device 1205, but includes only a single container rather than multiple containers. As shown in FIG. 13, device 1205 includes an outlet line 1340 fluidly coupled to the outlet of coupler 1210, where outlet line 1240 includes a valve 1342 and a downstream container 1344. Priming of system 1300 is substantially similar to the method of priming system 1000 described herein.
[0179] As mentioned above, some catheters supplied by manufacturers are not pre-connected to a urine drainage line and container. For such catheters, alternative systems, devices, and methods different from those described in Figures 12 and 13 can be used to present such catheters and associated devices for use. Figures 14A and 14B, for example, show a schematic urine collection system 1400 in accordance with an embodiment of the present technology. As shown in Figure 14A, the system 1400 can include a fluid source 122 and a port 1232 (previously described in Figures 12 and 13), as well as an adapter 1402 (e.g., an adapter including an outlet luer fitting) coupled to and downstream of the port 1232, a connector 1404 coupled to and downstream of the adapter 1402, and an outlet line 1240 coupled to and downstream of the connector 1404 (previously described in Figures 12 and 13). The outlet line 1240 may include a connector 1242 having a first end fluidly coupled to a valve 1246 and a first container 1250 downstream thereof, and a second end fluidly coupled to a valve 1248 and a second container 1252 downstream thereof. In some embodiments, the outlet line 1240 may include only a single container.
[0180] In operation, the system 1400 can be primed by injecting fluid from the fluid source 122 through the port 1232, the adapter 1402, the connector 1404, and the outlet line 1240. As described above, the valves 1246, 1248 can be individually opened and closed until fluid fills the corresponding lines. Once the system 1400 is primed and the valves 1246, 1248 are closed, the fluid source 122 can be disconnected from the connector 1404. Next, with reference to FIG. 14B, the catheter 118 can be coupled to the connector 1404 and then inserted into the patient for use.
[0181] 15A and 15B are perspective and cross-sectional views, respectively, of another pumping and / or priming assembly 1500 ("assembly 1500") configured in accordance with an embodiment of the present technology. The assembly 1500 can include an elongated adapter body 1502 having a first end portion 1502a and an opposing second end portion 1502b. The body 1502 can include a priming element 1506 at least partially enclosed within a priming portion 1504. In the illustrated embodiment, the priming portion 1504 has a cylindrical shape and extends radially outward from the body 1502 in a direction generally perpendicular to a longitudinal axis of the body 1502. In other embodiments, the priming portion 1504 can have any other shape and / or configuration. For example, the priming element 1506 can be generally flexible and configured to curve or bend within the priming portion 1054 to drive fluid flow through the assembly 1500 to prime the assembly 1500 and / or one or more components connected thereto. In some embodiments, the priming element 1506 can include an air filter, such as an X5008 hydrophobic air filter commercially available from Qosina Corp., headquartered in Ronkonkoma, New York, or any other suitable air filter.
[0182] The body 1502 can be configured to receive one or more components. In the illustrated embodiment, for example, a first end portion 1502a of the body 1502 is configured to receive a first line coupling component 1510 ("first component 1510") and a second line coupling component 1520 ("second component 1520"). The first component 1510 can include a fitting 1514 configured to couple to a fluid line (e.g., fluid line 119, FIG. 1A) or another appropriate part of a fluid management system. The second component 1520 can include a port 1524 configured to couple to a Foley catheter (e.g., Foley catheter 118, FIG. 1B). Each of the body 1502, the first component 1510, and the second component 1520 can be hollow and define a general lumen 1508 extending through the assembly 1500. In some embodiments, first component 1510 includes a barbed fitting, such as the 61764 barbed fitting commercially available from Qosina Corp. or any other suitable barbed fitting. In some embodiments, second component 1520 includes a Foley catheter adapter, such as the 09-875-7104 sample port connector manufactured by Denmark-based Carmo A / S or any other suitable Foley catheter adapter.
[0183] 15C and 15D are enlarged cross-sectional views of a priming portion 1504 in accordance with an embodiment of the present technology. With reference to FIG. 15C, in some embodiments, a priming element 1506 can be press-fit into the priming portion 1504. With reference to FIG. 15D, in some embodiments, the priming portion 1504 can include an annular lip or rim 1505, and the priming element 1506 can be positioned below the rim 1505.
[0184] 15A-15D together, priming of assembly 1500 is substantially similar to the method of priming system 1000 described herein. For example, priming element 1506 can be repeatedly depressed in a radially inward direction to remove air from one or more fluid lines and / or other components of a fluid management system coupled to assembly 1500.
[0185] Any of the pumping devices and / or priming devices described herein can be incorporated into any of the other systems and devices described herein. For example, pumping device 1002 of FIG. 10 can be incorporated into any fluid line that receives urine from a patient, such as fluid line 119 of FIG. 1A and fluid lines 426a and / or 426b of FIG. 4A-4J. Similarly, the processes described herein for priming and / or clearing obstructions from a fluid line can be performed before and / or during any of the treatment procedures of the present technology.
[0186] III. Conclusion The technology of the present invention is exemplified according to various aspects, for example, as described below. Various examples of the aspects of the technology of the present invention are described as numbered examples (such as 1, 2, 3) for convenience. These examples do not limit 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.
[0187] Working Example 1. A system for collecting urine from a patient comprising a first container, a second container, at least one sensor configured to generate sensor data indicative of an amount of urine in the first and second containers, and a flow control assembly configured to direct a flow of urine from the patient into the first container or the second container based on the sensor data. 2. The system of example 1, wherein the at least one sensor comprises one or more of a weight sensor, a flow sensor, or a fluid level sensor. 3. The system of example 1 or example 2, wherein the sensor data includes first sensor data indicative of a first volume of urine in the first container and first sensor data indicative of a second volume of urine in the second container. 4. The system of example 3, wherein the flow control assembly is configured to direct urine flow away from the first container and into the second container when the first sensor data indicates that the first urine volume exceeds a threshold value. 5. The system of Example 4, further comprising at least one second sensor configured to detect the presence of a second container, and wherein the flow control assembly is configured to direct the urine flow into the second container when the first urine volume is greater than a threshold and the second container is present. 6. The system of example 4 or example 5, further comprising a notification device configured to output a notification when the first urine volume exceeds a threshold value. 7. The system of example 6, wherein the notification includes one or more of a light, a sound, a message displayed on the system's user interface, or a message sent to a separate device. 8. The system of any one of Examples 1 to 7, wherein the flow control assembly includes a first valve coupled to the first container, a second valve coupled to the second container, and at least one actuator configured to actuate the first and second valves to control fluid flow into the first and second containers, respectively. 9. The system of example 8, wherein each of the first and second valves includes a rotatable cam unit. 10. The system of any one of Examples 1 to 9, further comprising a first retainer configured to secure the first container to the flow control assembly, and a second retainer configured to secure the second container to the flow control assembly. 11. The system of example 10, wherein the flow control assembly is configured to lock the first retainer and unlock the second retainer when the urine flow is directed into the first container, and to lock the second retainer and unlock the first retainer when the urine flow is directed into the second container. 12. The system of any one of Examples 1 to 11, wherein the flow control assembly is coupled to a catheter on or within the patient's body. 13. A method of collecting urine from a patient comprising the steps of directing a flow of urine from the patient into a first container through a flow control assembly, measuring a volume of urine in the first container with at least one sensor, detecting with the at least one sensor that the volume of urine in the first container exceeds a threshold value, and actuating the flow control assembly to direct the urine flow into the second container instead of the first container. 14. The method of example 13, further comprising measuring the volume of urine in the second container with at least one second sensor. 15. The method of example 14, wherein the urine flow is directed away from the first container and into the second container when (1) the urine volume in the first container is greater than a threshold value and (2) the urine volume in the second container is less than a threshold value. 16. The method of example 15, further comprising detecting using at least one sensor that the volume of urine in the first container is less than a threshold value, detecting using at least one second sensor that the volume of urine in the second container exceeds a threshold value, and actuating a flow control assembly to direct the flow of urine away from the second container and into the first container. 17. The method of any one of Examples 13 to 16, further comprising detecting whether the second container is present with at least one third sensor. 18. The method of example 17, wherein the urine flow is directed away from the first container and into the second container when (1) the urine volume in the first container is greater than a threshold value and (2) the second container is present. 19. The method of any one of Examples 13 to 18, further comprising the steps of locking the first container to the flow control assembly when the urine flow is directed into the first container, and unlocking the first container from the flow control assembly when the urine flow is directed into the second container. 20. The method of any one of Examples 13 to 19, further comprising outputting a notification indicating that the amount of urine in the first container has exceeded a threshold value. 21. The method of any one of Examples 13 to 20, further comprising the steps of detecting whether one or both of the first or second containers are present using at least one fourth sensor, and outputting a first signal indicating that a medical procedure on the patient can begin. 22. The method of example 21, wherein the medical procedure comprises treating a patient for a fluid overload condition. 23. The method of example 21 or example 22, wherein the medical procedure comprises monitoring the patient's urination. 24. The method of any one of Examples 21 to 23, further comprising the steps of receiving a second signal indicating that the medical procedure is completed, and unlocking one or both of the first or second containers from the flow control assembly. 25. A device for collecting urine from a patient comprising: a first fluid line configured to be coupled to a patient's body; a second fluid line configured to be coupled to a urine container; a hollow member including a first end portion coupled to the first fluid line and comprising a first check valve, a second end portion coupled to the second fluid line and comprising a second check valve, and a flexible body portion fluidly coupling the first end portion and the second end portion to allow fluid flow from the patient's body to the urine container. 26. A device according to example 25, wherein a first check valve is configured to inhibit fluid flow from the hollow member into the first fluid line, and a second check valve is configured to inhibit fluid flow from the second fluid line into the hollow member. 27. The device of example 25 or example 26, wherein the flexible body portion is actuable between a relaxed configuration and a compressed configuration. 28. The device of Example 27, wherein the flexible body portion is configured to be repeatedly actuated to move air from one or both of the first or second fluid lines into the container. 29. A device of Example 27 or Example 28, wherein the flexible body portion is configured to be repeatedly actuated to draw fluid from the patient's body into one or both of the first or second fluid lines. 30. The device of any one of examples 27 to 29, wherein the flexible body portion is configured to be manually actuated. 31. The device of any one of examples 27 to 30, wherein the flexible body portion is configured to be actuated by an automatic mechanism. 32. The device of any one of examples 25 to 31, wherein in use the hollow member is oriented with the second end portion above the first end portion. 33. The device of any one of examples 25 to 32, wherein one or both of the first or second fluid lines have an inner diameter less than or equal to 1 / 8 inch. 34. The device of any one of Examples 25 to 33, further comprising a catheter configured to couple the first fluid line to a patient's body. 35. A method of collecting urine from a patient comprising the steps of connecting a urine container to the patient's body through at least one fluid line fluidly coupled to a pumping device between the patient's body and the urine container, actuating a flexible body portion of the pumping device to move fluid through the at least one fluid line toward the urine container, and restricting fluid flow out of the urine container with at least one valve of the pumping device. 36. The method of example 35, wherein the actuating step comprises compressing the flexible body portion one or more times. 37. The method of example 35 or example 36, further comprising the step of detecting an air lock in at least one fluid line, and wherein the actuating step is performed to remove the air lock. 38. The method of any one of Examples 35 to 37, wherein the actuating step is performed to draw urine from the patient's body into at least one fluid line. 39. The method of any one of Examples 35 to 38, wherein the actuating step is performed to treat a patient for fluid overload during a medical procedure. 40. The method of any one of embodiments 35 to 39, wherein the at least one valve comprises at least one check valve. 41. The method of any one of examples 35 to 40, wherein the at least one fluid line includes a first fluid line connected to the patient's body and a second fluid line connected to a urine container, and the pumping device fluidly couples the first fluid line to the second fluid line. 42. A system configured to collect urine from a patient comprising: a coupler including a first inlet, a second inlet, and an outlet; a first line coupled to the first inlet of the coupler and configured to be fluidly coupled to a fluid source; a second line coupled to the second inlet of the coupler, including a first valve and configured to be fluidly coupled to a catheter or a patient; and a third line coupled to the outlet of the coupler and including a second valve and a container downstream thereof. 43. The system of example 42, wherein the first line includes a port configured to be fluidly coupled to a fluid source, and a check valve between the port and the coupler. 44. The system of example 43, wherein the port is a needleless luer connector. 45. The system of any one of Examples 42 to 44, further comprising a controller operably coupled to the first valve and the second valve and configured to regulate the valves. 46. The system of any one of Examples 42 to 45, further comprising a fluid source comprising saline. 47. The system of any one of Examples 42 to 46, further comprising a catheter that is a Foley catheter. 48. The system of any one of Examples 42 to 47, wherein the container is a first container, and the third line further comprises a connector having a first end fluidly coupled to the second valve and the first container, and a second end fluidly coupled to the third valve and a second container downstream thereof. 49. A method of priming a system configured to collect urine from a patient, comprising the steps of providing the system of any one of Examples 42 to 47, injecting fluid from a fluid source through a first valve by adjusting one valve, and injecting fluid from the fluid source into a container by adjusting a second valve. 50. A method of priming a system configured to collect urine from a patient, comprising the steps of providing the system of Example 48, injecting fluid from a fluid source through a first valve by adjusting one valve, injecting fluid from the fluid source to a first container by adjusting a second valve, and injecting fluid from the fluid source to a second container by adjusting a third valve. 51. A system for collecting urine from a patient comprising: a container configured to collect urine, a first sensor configured to obtain a weight of the container, a supply line fluidly coupled to the container and configured to receive urine from the patient, a second sensor configured to obtain a flow rate of urine in the supply line, and a controller operably coupled to the first sensor and the second sensor. 52. The system of Example 51, further comprising a valve operably coupled to the controller and disposed on the supply line between the second sensor and the container, the controller configured to actuate and close the valve when the weight of the container is less than a predetermined threshold. 53. The system of Example 52, further comprising a reservoir disposed on the supply line between the second sensor and the valve. 54. A patient treatment system comprising the system of any one of the embodiments herein and the device of any one of the embodiments herein. 55. A system for collecting urine from a patient comprising: a container configured to collect urine; a first sensor configured to generate first sensor data indicative of the amount of urine in the container; a second sensor configured to generate second sensor data indicative of the amount of urine in the container; one or more processors; and one or more non-transitory computer-readable media having instructions that, when executed by the one or more processors, cause the system to determine urination of the patient based at least in part on the first sensor data, detect when urine is withdrawn from the container, and determine urination of the patient based at least in part on the second sensor data while at least urine is withdrawn from the container. 56. The system of example 55, wherein the first sensor includes a weight sensor and the second sensor includes a flow sensor. 57. The system of any one of examples 55 to 56, wherein the first sensor data includes a weight of the container and the second sensor data includes a urine flow rate. 58. The system of any one of Examples 55 to 57, further comprising a container mounting component operably coupled to the first sensor and configured to releasably hold the container. 59. The system of example 58, wherein the container mounting component includes a hook configured to suspend the container while the container is in operative engagement with the first sensor. 60. The system of any one of examples 57 to 59, wherein the instructions for detecting when urine is drawn from the container include instructions for detecting when urine is drawn from the container based at least in part on a decrease in weight of the container. 61. The system of example 60, wherein the instructions further include instructions for detecting when urine is no longer being drawn from the container. 62. The system of example 61, wherein the instructions for detecting when urine is no longer being drawn from the container include instructions for detecting when urine is no longer being drawn from the container based at least in part on an increase in weight of the container. 63. The system of any one of Examples 55 to 62, further comprising a urine supply line fluidly coupling the patient and the container, and a urine cartridge configured to operably engage at least a portion of the urine supply line with the second sensor. 64. The system of Example 63, wherein the urine cartridge includes one or more openings configured to receive at least a portion of the urine supply line. 65. The system of example 63 or example 64, wherein the urine cartridge includes a tab configured to engage a portion of the urine supply line toward at least one of the first sensor or the second sensor. 66. A method of collecting urine from a patient comprising the steps of directing a flow of urine from the patient into a container through a flow control assembly, measuring the amount of urine in the container with a first sensor, detecting when urine is withdrawn from the container with the first sensor, and measuring urination of the patient at least when urine is being discharged with a second sensor. 67. The method of example 66, wherein the first sensor includes a weight sensor, and the step of measuring the amount of urine in the container includes the step of measuring the weight of the container using the weight sensor. 68. The method of any one of examples 66 to 67, wherein the second sensor includes a flow sensor, and measuring the patient's urination includes measuring a urine flow rate using the second sensor. 69. The method of any one of examples 66 to 68, wherein detecting when urine is drawn from the container comprises detecting when urine is drawn from the container based at least in part on a decrease in weight of the container. 70. The method of any one of Examples 66 to 69, further comprising detecting when urine is no longer being drawn from the container. 71. The method of example 70, wherein detecting when urine is no longer being withdrawn from the container includes detecting when urine is no longer being withdrawn from the container based at least in part on the first sensor. 72. The method of any one of Examples 70 to 71, wherein the step of detecting when urine is no longer being drawn from the container comprises detecting when urine is no longer being drawn from the container based at least in part on an increase in weight of the container. 73. A urine collection system comprising: a first sensor configured to generate first sensor data based on a weight of a container positioned to collect urine from a patient; a second sensor configured to generate second sensor data based on urine flow from the patient to the container; one or more processors; and one or more non-transitory computer-readable media having instructions that, when executed by the one or more processors, cause the system to perform operations comprising determining a first patient urination based on the first sensor data; and determining a second patient urination based on the second sensor data. 74. The system of Example 73, wherein operation further comprises determining through first sensor data that a weight of the container is decreasing, and utilizing a second patient output as a primary input after determining that a weight of the container is decreasing, wherein the first patient output and the second patient output are average volumetric flow rates over a period of time. 75. The system of example 74, wherein operation further comprises utilizing a first patient urination as a primary input prior to the step of determining that the weight of the container is decreasing. 76. The system of Example 74, wherein the operation further comprises the steps of determining that the weight of the container is increasing after the step of determining that the weight of the container is decreasing, and utilizing a first patient urination as a primary input after the step of determining that the weight of the container is increasing. 77. The system of any one of Examples 73 to 76, wherein operation further comprises utilizing the first patient urination as the primary input if the difference between the first patient urination and the second patient urination is less than a predetermined threshold, and utilizing the second patient urination as the primary input if the difference between the first patient urination and the second patient urination is not less than the predetermined threshold. 78. The system of any one of Examples 73 to 77, further comprising a mounting component operably coupled to the first sensor, the mounting component configured to support a container positioned to collect urine, wherein the weight of the container is transmitted to the first sensor through the mounting component. 79. The system of Example 78, further comprising a container including a drainage valve, the container being configured to be drained while supported by the mounting component. 80. The system of Example 78, further comprising a console (i) enclosing the first sensor and the second sensor, and (ii) at least partially defining an indentation area, wherein the mounting component is positioned in the indentation area, and the first sensor and the second sensor are above the indentation area. 81. The system of any one of Examples 73 to 80, further comprising: (i) a console including a receiving area and (ii) a second sensor disposed in the receiving area; and a urine flow assembly removably coupled to the console at the receiving area such that a portion of the second sensor and a portion of the urine flow assembly together define a slot configured to receive tubing configured to direct urine from the patient to a container. 82. The system of any one of Examples 73 to 81, further comprising: (i) a console including a receiving area and (ii) a second sensor disposed in the receiving area; and a urine flow assembly removably attached to the console and having a plurality of ports defining a tubing path for directing urine from the patient to a container. 83. The system of any one of Examples 73 to 82, further comprising a pinch valve upstream of the container, the pinch valve positioned to receive tubing configured to direct urine flow from the patient to the container, the pinch valve configured to regulate urine flow without contacting the urine. 84. A method of collecting urine from a patient comprising: measuring first sensor data via a first sensor comprising a weight of a container configured to receive a urine flow from the patient; generating a first patient urination via the first sensor data; determining that a weight of the container is decreasing; and after determining that a weight of the container is decreasing, measuring second sensor data via a second sensor comprising a second patient urination. 85. The method of example 84, further comprising utilizing the first patient urination if a difference between the first patient urination and the second patient urination is less than a predetermined threshold, and utilizing the second patient urination if a difference between the first patient urination and the second patient urination is not less than the predetermined threshold. 86. The method of any one of Examples 84 to 85, further comprising the steps of: utilizing a first patient urination as a primary input prior to the step of determining that the weight of the container is decreasing; and utilizing a second patient urination as a primary input after the step of determining that the weight of the container is decreasing. 87. The method of example 86, further comprising the steps of determining that the weight of the container is increasing after the step of determining that the weight of the container is decreasing, and utilizing a first patient urination as a primary input after the step of determining that the weight of the container is increasing. 88. The method of any one of Examples 84 to 87, wherein determining that the weight of the container is decreasing comprises detecting via a first sensor that the weight of the container is decreasing. 89. The method of any one of Examples 84 to 88, further comprising directing urine from the patient through a flow control assembly to a container. 90. The method of example 89, further comprising the step of detecting the presence of the container via the first sensor prior to the step of directing urine from the patient to the container. 91. The method of example 89, wherein the flow control assembly includes a plurality of ports and tubing extending through the ports to the container, and wherein directing urine from the patient to the container comprises directing a urine flow from the patient through the tubing toward the container, and wherein measuring a second patient output comprises measuring the urine flow directed through the tubing to the container. 92. A fluid therapy system comprising a first pump configured to provide a diuretic to the patient, a second pump configured to provide a rehydration fluid to the patient, and a urinary system including a urine collection device, a flow control assembly configured to direct urine flow from the patient to the urine collection device, and a urine measurement device including a first sensor configured to generate first sensor data based on a weight of the container and a second sensor configured to generate second sensor data based on urine flow from the patient to the container. 93. The system of Example 92, further comprising one or more processors and one or more non-transitory computer readable media having instructions that, when executed by the one or more processors, cause the system to perform operations comprising determining a first patient urination based on the first sensor data, and determining a second patient urination based on the second sensor data. 94. The system of example 93, wherein the operation further comprises determining an amount of diuretic to be provided to the patient based on the first patient urination. 95. The system of example 94, wherein operation further comprises determining that a weight of the urine collection device is decreasing and, after determining that a weight of the container is decreasing, determining an amount of diuretic to be provided to the patient based on a second patient urination. 96. The system of example 95, wherein the operation further comprises, after the step of determining that the weight of the urine collection device is decreasing, determining that the weight of the urine collection device is increasing, and, after the step of determining that the weight of the container is increasing, determining an amount of diuretic to be provided to the patient based on the first patient urination. 97. The system of any one of Examples 92 to 97, wherein operation further comprises utilizing the first patient urination as the primary input if a difference between the first patient urination and the second patient urination is less than a predetermined threshold, and utilizing the second patient urination as the primary input if a difference between the first patient urination and the second patient urination is not less than the predetermined threshold.
[0188] 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 present technology. 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 present technology. Although stages of the method may be provided in a particular order herein, alternative embodiments may perform these stages in a different order. Similarly, certain aspects of the present technology disclosed in the context of certain embodiments may be combined or eliminated in other embodiments. Furthermore, although advantages associated with certain embodiments of the present technology may be disclosed in the context of these embodiments, other embodiments may exhibit such advantages, and not all embodiments necessarily exhibit such advantages or other advantages disclosed herein to fall within the present technology. Thus, the present disclosure and related technology 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.
[0189] The singular forms "a," "an," and "the" include plural referents unless the context clearly indicates otherwise throughout this disclosure. Reference herein to "one embodiment," "embodiments," "some embodiments," or similar phrases means that a particular feature, structure, operation, or characteristic described in connection with that embodiment can be included in at least one embodiment of the present technology. Thus, appearances of such a phrase or phrases herein are not necessarily all referring to the same embodiment. Furthermore, various particular features, structures, operations, or characteristics can be combined in any suitable manner in one or more embodiments.
[0190] Unless otherwise indicated, all numbers expressing volumes, flow rates, 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. The term "about" refers to values ranging from ±10% of the stated value when used. 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 at least the number of significant digits disclosed and by applying ordinary rounding techniques. In addition, all ranges disclosed herein should be understood to encompass any and all subranges contained 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.
[0191] 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.
[0192] Additional Notes (Appendix 1) 1. A urine collection system comprising: a first sensor configured to generate first sensor data based on a weight of a container positioned to collect urine from the patient; a second sensor configured to generate second sensor data based on urine flow into the container; one or more processors; When executed by the one or more processors, determining a first patient urination based on the first sensor data; determining a second patient urination based on the second sensor data; determining a rate of change of the weight of the container via the first sensor data; and designating the second patient urination as a primary input after determining whether the rate of change is less than a predetermined threshold rate; One or more non-transitory computer-readable media having instructions for causing a system to perform operations comprising: A system comprising: (Appendix 2) 2. The system of claim 1, wherein the operation further comprises a step of designating the first patient urination as the primary input before determining whether the rate of change is less than the predetermined threshold rate. (Appendix 3) The operation is determining whether the weight of the container has increased and / or whether the rate of change is greater than or equal to the predetermined threshold rate after determining whether the rate of change is less than the predetermined threshold rate; designating the first patient urination as the primary input after determining whether the weight of the container is increasing and / or whether the rate of change is greater than or equal to the predetermined threshold rate; Further comprising: 2. The system of claim 1, (Appendix 4) a mounting component operably coupled to the first sensor, the mounting component configured to support the container positioned to collect urine; the weight of the container is communicated to the first sensor through the mounting component; 2. The system of claim 1, (Appendix 5) the container includes a drain valve; the container is configured to be drained while supported by the mounting component; 5. The system of claim 4. (Appendix 6) a console that (i) encases the first sensor and the second sensor, and (ii) at least partially defines a recessed area; the mounting component is positioned in the recessed area; the first sensor and the second sensor are above the invaginated area; 5. The system of claim 4. (Appendix 7) 1. A urine collection system comprising: a first sensor configured to generate first sensor data based on a weight of a container positioned to collect urine from the patient; a fluid line configured to direct urine from the patient to the container; a second sensor configured to generate second sensor data based on urine flow through the fluid line to the container; a console including a receiving area, the second sensor being positioned within the console on a first side of the receiving area; a urine cartridge configured to receive the fluid line, the urine cartridge being removably coupled to the console on a second side of the receiving area, the urine cartridge being configured such that when the urine cartridge is coupled to the console, a portion of the second sensor and a portion of the urine cartridge together define a slot that directly receives the fluid line; one or more processors; When executed by the one or more processors, determining a first patient urination based on the first sensor data; and determining a second patient urination based on the second sensor data; One or more non-transitory computer-readable media having instructions for causing a system to perform operations comprising: A system comprising: (Appendix 8) a console including a receiving area, the second sensor being positioned within the console at the receiving area; a urine cartridge removably attached to the console, the urine cartridge including a plurality of ports defining a path for directing urine from the patient to the container; 2. The system of claim 1, further comprising: (Appendix 9) and a flow control device upstream of the container, the flow control device positioned to receive a fluid line configured to direct urine flow from the patient to the container. The flow control device is configured to regulate the flow of urine without contacting the urine. 2. The system of claim 1, (Appendix 10) a urine cartridge and a fluid line coupled to the urine cartridge; The urine cartridge is removably attached to a console that houses the first sensor and the second sensor. 2. The system of claim 1, (Appendix 11) a console housing the second sensor; a fluid line configured to direct urine from the patient to the container; a urine cartridge including a plurality of ports configured to receive the fluid line, the urine cartridge removably attached to the console such that a portion of the fluid line is positioned adjacent to the second sensor; 2. The system of claim 1, further comprising: (Appendix 12) a third sensor on the console; the third sensor is configured to detect whether the urine cartridge is coupled to the console; 12. The system of claim 11, (Appendix 13) 1. A method for collecting urine from a patient, comprising: measuring first sensor data via a first sensor, the first sensor data including a weight of a container configured to receive a urine flow from the patient; generating a first patient urination event via the first sensor data; designating the first patient urination as a primary input; determining a rate of change of the weight of the container via the first sensor data; measuring second sensor data via a second sensor, the second sensor data including a second patient urination event; designating the second patient urination as the primary input based on one or more of: the weight of the container being greater than a predetermined threshold, the rate of change of the weight of the container being less than a predetermined threshold rate, or a discrepancy between the first sensor data and the second sensor data being greater than a predetermined discrepancy threshold; 23. A method comprising: (Appendix 14) 14. The method of claim 13, further comprising directing urine flow from the patient through a flow control assembly to the container. (Appendix 15) 15. The method of claim 14, further comprising detecting the presence of a container via the first sensor prior to directing the urine flow from the patient to the container. (Appendix 16) the flow control assembly includes a plurality of ports and fluid lines extending through the ports to the container; directing the flow of urine from the patient to the container comprises directing the flow of urine from the patient to the container through the fluid line; measuring the second patient output comprises measuring the urine flow directed through the fluid line to the container. 15. The method according to claim 14, (Appendix 17) the second sensor is housed in a console, and the flow control assembly includes a urine cartridge including a fluid line configured to direct the urine flow from the patient to the container; The method further comprising: coupling the urine cartridge to the console prior to the step of directing the urine flow from the patient to the container; Further comprising: 15. The method according to claim 14, (Appendix 18) 8. The system of claim 7, wherein a portion of the fluid line extending through the slot is oriented vertically. (Appendix 19) The urine cartridge further comprises an engagement feature; when the urine cartridge is coupled to the console, the engagement feature is on the second side of the receiving area and extends from the urine cartridge toward the fluid line. 8. The system of claim 7, (Appendix 20) The urine cartridge further comprises an engagement feature; When the urine cartridge is coupled to the console, the engagement feature contacts the fluid line. 8. The system of claim 7, (Appendix 21) 8. The system of claim 7, wherein the second side is opposite the first side. (Appendix 22) 2. The system of claim 1, wherein the predetermined threshold rate is a value less than zero. [Explanation of symbols]
[0193] 600 Urine Collection System 602 Urinary System 604 Automatic rehydration fluid injection system 606 Automatic Diuretic Injection System 608 Controller
Claims
1. 1. A urine collection system comprising: a first sensor configured to generate first sensor data based on a weight of a container positioned to collect urine from a patient; a second sensor configured to generate second sensor data based on urine flow into the container; one or more processors; When executed by the one or more processors, determining a first patient urination based on the first sensor data; and determining a second patient urination based on the second sensor data; One or more non-transitory computer-readable media having instructions for causing a system to perform operations comprising: A system comprising:
2. The operation is determining through the first sensor data that the weight of the container is decreasing; utilizing the second patient output as a primary input after determining that the weight of the container is decreasing; Further comprising: the first patient output and the second patient output are average volumetric flow rates over a period of time; 2. The system of claim 1 .
3. 3. The system of claim 2, wherein said operation further comprises utilizing said first patient output as said primary input prior to the step of determining that said weight of said container is decreasing.
4. The operation is determining that the weight of the container is increasing after the step of determining that the weight of the container is decreasing; utilizing the first patient output as the primary input after determining that the weight of the container is increasing; Further comprising:
3. The system of claim 2.
5. The operation is utilizing the first patient urination as a primary input if a difference between the first patient urination and the second patient urination is less than a predetermined threshold; utilizing the second patient urination as the primary input if the difference between the first patient urination and the second patient urination is not less than the predetermined threshold; Further comprising:
2. The system of claim 1 .
6. a mounting component operably coupled to the first sensor, the mounting component configured to support the container positioned to collect urine; the weight of the container is communicated to the first sensor through the mounting component; 2. The system of claim 1 .
7. the container further comprising a drain valve; the container is configured to be drained while supported by the mounting component; 7. The system of claim 6.
8. (i) a console encasing the first sensor and the second sensor, and (ii) at least partially defining an invagination area; the mounting component is positioned in the recessed area; the first sensor and the second sensor are above the invaginated area.
7. The system of claim 6.
9. a fluid line configured to direct urine from the patient to the container; a console including a receiving area, the second sensor being positioned within the console on a first side of the receiving area; a urine cartridge removably coupled to the console on a second side of the receiving area, the urine cartridge such that a portion of the second sensor and a portion of the urine cartridge together define a slot configured to receive the fluid line; 2. The system of claim 1, further comprising:
10. a console including a receiving area, the second sensor being positioned within the console at the receiving area; a urine cartridge removably attached to the console, the urine cartridge including a plurality of ports defining a path for directing urine from the patient to the container; 2. The system of claim 1, further comprising:
11. and a flow control device upstream of the container, the flow control device positioned to receive a fluid line configured to direct urine flow from the patient to the container. The flow control device is configured to regulate the flow of urine without contacting the urine.
2. The system of claim 1 .
12. a urine cartridge and a fluid line coupled to the urine cartridge; the urine cartridge is removably attached to a console housing the first sensor and the second sensor; 2. The system of claim 1 .
13. a console housing the second sensor; a fluid line configured to direct urine from the patient to the container; a urine cartridge including a plurality of ports configured to receive the fluid line, the urine cartridge removably attached to the console such that a portion of the fluid line is positioned adjacent to the second sensor; 2. The system of claim 1, further comprising:
14. a third sensor on the console; the third sensor is configured to detect whether the urine cartridge is coupled to the console; 14. The system of claim 13.
15. 1. A method for collecting urine from a patient, comprising: measuring first sensor data via a first sensor, the first sensor data including a weight of a container configured to receive a urine flow from a patient; generating a first patient output via the first sensor data; determining that the weight of the container is decreasing; measuring second sensor data via a second sensor including a second patient output after determining that the weight of the container is decreasing; 23. A method comprising:
16. utilizing the first patient output if a difference between the first patient output and the second patient output is less than a predetermined threshold; utilizing the second patient output if the difference between the first patient output and the second patient output is not less than the predetermined threshold; 20. The method of claim 15 further comprising:
17. utilizing the first patient output as a primary input prior to determining that the weight of the container is decreasing; utilizing the second patient output as the primary input after determining that the weight of the container is decreasing; 20. The method of claim 15 further comprising:
18. determining that the weight of the container is increasing after the step of determining that the weight of the container is decreasing; utilizing the first patient output as the primary input after determining that the weight of the container is increasing; 20. The method of claim 17 further comprising:
19. 16. The method of claim 15, wherein determining that the weight of the container is decreasing comprises detecting via the first sensor that the weight of the container is decreasing.
20. 16. The method of claim 15, further comprising directing urine flow from the patient through a flow control assembly to the container.
21. 21. The method of claim 20, further comprising the step of detecting the presence of the container via the first sensor prior to the step of directing the urine flow from the patient to the container.
22. the flow control assembly includes a plurality of ports and fluid lines extending through the ports to the container; directing the flow of urine from the patient to the container comprises directing the flow of urine from the patient through the fluid line to the container; measuring the second patient output comprises measuring the urine flow directed through the fluid line to the container.
21. The method of claim 20.
23. the second sensor is housed in a console, and the flow control assembly includes a urine cartridge including a fluid line configured to direct the urine flow from the patient to the container; The method further comprising: coupling the urine cartridge to the console prior to the step of directing the urine flow from the patient to the container; Further comprising:
21. The method of claim 20.
24. a first pump configured to provide a diuretic to the patient; a second pump configured to provide rehydration fluid to the patient; A urinary system, The urinary system comprises: A urine collection device; a flow control assembly configured to direct urine flow towards the urine collection device; a urine measuring device including a first sensor configured to generate first sensor data based on a weight of a container and a second sensor configured to generate second sensor data based on the urine flow from the patient to the container; 16. A fluid therapy system comprising:
25. one or more processors; When executed by the one or more processors, determining a first patient urination based on the first sensor data; and determining a second patient urination based on the second sensor data; One or more non-transitory computer-readable media having instructions for causing a system to perform operations comprising:
25. The system of claim 24, further comprising:
26. 26. The system of claim 25, wherein the operation further comprises determining an amount of the diuretic to be provided to the patient based on the first patient output.
27. The operation is determining that the weight of the urine collection device is decreasing; determining, after the step of determining that the weight of the container has decreased, the amount of the diuretic to be provided to the patient based on the second patient output; Further comprising:
27. The system of claim 26.
28. The operation is determining, after the step of determining that the weight of the urine collection device is decreasing, that the weight of the urine collection device is increasing; determining, after the step of determining that the weight of the container has increased, the amount of the diuretic to be provided to the patient based on the first patient urination; Further comprising:
28. The system of claim 27.
29. The operation is utilizing the first patient urination as a primary input if a difference between the first patient urination and the second patient urination is less than a predetermined threshold; utilizing the second patient urination as the primary input if the difference between the first patient urination and the second patient urination is not less than the predetermined threshold; Further comprising:
26. The system of claim 25.
30. The urine measurement device includes a console that houses the second sensor, and the flow control assembly includes: a fluid line configured to direct the urine flow from the patient to the urine collection device; a urine cartridge configured to receive the fluid line and removably attached to the console such that a portion of the fluid line is positioned adjacent to the second sensor; 25. The system of claim 24, comprising: