Measurement of urine production and other urinary parameters

Abstract

The device (129) for use with a conduit (371) configured to carry urine downstream from a subject's bladder (122) includes one or more force imparting elements (22, 350, 352) configured to reversibly couple to the conduit (371) and to apply a force to the conduit (371) when coupled to the conduit (371). The device (129) further includes a controller (125) configured to control the force imparting elements (22, 350, 352) such that the force imparting elements (22, 350, 352) apply a force to the conduit (371), thereby propelling urine in a downstream direction from the conduit (371), and to calculate an amount of urine propelled based on the control of the force imparting elements (22, 350, 352). Other embodiments are also described.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Patent Application No. 63 / 201,125, filed April 14, 2021, the disclosure of which is incorporated herein by reference.

[0002] The present invention relates generally to the field of medical devices, and more particularly to systems and methods for facilitating diagnosis and / or treatment of a subject connected to a urinary catheter. [Background technology]

[0003] U.S. Patent No. 9,752,914, commonly assigned to Levine, describes a method, apparatus, and system for determining the flow rate of a waste stream in a waste collection assembly. In some embodiments, one of the components of the collection assembly includes a sensing module that includes electrical and / or electromechanical components.

[0004] U.S. Patent No. 10,240,590, commonly assigned to Levine, describes a fluid flow meter having a fluid pump configured to move fluid in pumping strokes of one or more pumping stroke types, each of which moves a known volume of fluid. The fluid flow meter further includes a sensor operatively associated with a fluid reservoir and configured to generate a signal indicative of a fluid pumping condition in the fluid reservoir, the fluid reservoir being integral with or operatively associated with the pump, and a circuit configured to trigger a stroke or series of strokes of the pump in response to a signal from the sensor.

[0005] International Patent Application Publication WO / 2019 / 106674 (Patent Document 3) describes a dual active valve positive displacement pump having a housing that holds the pump components and a piston with an internal cavity divided into two fluidly separated volumes by a freely moving diaphragm, one of the two volumes being fluidly connected to a volume between the piston and the housing that contains a driver pressure from a pressure source. The piston is reciprocally movable within the housing under a positive or negative driver pressure. An active inlet valve actuable by the driver pressure is actuated when the driver pressure is greater than a maximum pressure at the pump inlet port. An active outlet valve actuable by the driver pressure is actuated when the driver pressure is less than a minimum pressure at the pump outlet port. The diaphragm separates the pumped fluid from the actuating fluid used to move the diaphragm within the piston cavity and transmits pressure at the inlet port when the inlet valve is open and transmits pressure at the outlet port when the outlet valve is open.

[0006] International Patent Application Publication WO / 2019 / 106675 (Patent Document 4) describes an apparatus for measuring the rate of urine production in a subject, comprising a catheter, a pressure transducer, and a means for measuring the amount of urine produced. Urine flow from the bladder is prevented until a predetermined pressure is reached in the bladder. Urine flow is then allowed and the bladder pressure and the urine deposits leaving the bladder are measured. When the bladder pressure reaches a second, lower, predetermined pressure, urine flow is prevented again. From the pressure measured during urine flow and the amount of urine leaving the bladder, the intraperitoneal pressure and the urine production rate can be measured. [Prior art documents] [Patent documents]

[0007] [Patent Document 1] U.S. Patent No. 9,752,914 [Patent Document 2] U.S. Patent No. 10,240,590 [Patent Document 3] WO2019 / 106674 [Patent Document 4] WO2019 / 106675 Summary of the Invention

[0008] According to some embodiments of the invention, there is provided a device for use with a conduit configured to carry urine downstream from a subject's bladder. The device includes one or more force applying elements configured to reversibly couple to the conduit and to apply a force to the conduit when coupled to the conduit. The device further includes a controller configured to control the force applying elements such that the force applying elements apply a force to the conduit, thereby forcing urine in a downstream direction from the conduit, and to calculate an amount of urine forced based on the control of the force applying elements.

[0009] In some embodiments, the device further comprises a conduit.

[0010] In some embodiments, the force-applying element includes an actuator configured to reversibly couple to the conduit and apply a force to the conduit via fluid in the fluid-filled tube.

[0011] In some embodiments, the apparatus further comprises: coupled to the fluid filled tube to sense the fluid pressure of the fluid; transmitting a signal indicative of the fluid pressure to the controller; a pressure sensor configured to The controller is configured to control the force applying element in response to the signal.

[0012] In some embodiments, the conduit comprises a chamber including a movable wall, and the force applying element is configured to apply a force to the movable wall.

[0013] In some embodiments, the device further includes a case coupled to the force imparting element, the force imparting element configured to reversibly couple to the conduit by the case reversibly coupling to the conduit.

[0014] In some embodiments, the conduit is at least partially contained in the cartridge, and the case is formed to define a slot, and the case is configured to reversibly couple to the conduit via insertion of the cartridge into the slot.

[0015] In some embodiments, the conduit is coupled to one or more latches, and the case is configured to reversibly couple to the conduit by latching the latches to the case.

[0016] In some embodiments, the case includes one or more latches configured to latch to the housing of the conduit, thereby reversibly coupling the case to the conduit.

[0017] In some embodiments, the case comprises: an electrical interface connected to the controller and configured to couple to the cable such that the controller is powered via the cable; and a communications interface connected to the controller and configured to couple to the cable; Including, The controller is configured to communicate the calculated quantities, or parameters derived therefrom, via the communication interface and cable.

[0018] In some embodiments, the force applying element comprises: a pressing element; and an actuator configured to press a pushing element against the conduit to apply a force to the conduit; The controller is configured to control the actuator.

[0019] In some embodiments, the conduit comprises a tube and the pushing element is configured to push against the tube.

[0020] In some embodiments, the pushing element includes a rotor configured to rotate while pushing against the tube.

[0021] In some embodiments, the actuator is further configured to measure a reciprocal force exerted by the conduit on the pushing element, and the controller is configured to control the actuator in response to the reciprocal force.

[0022] In some embodiments, the actuator includes an encoder configured to detect a position of the push element, and the controller is configured to control the actuator in response to the position.

[0023] In some embodiments, the device further includes a sensor configured to transmit a signal to the controller that varies as a function of the amount of urine in the conduit or bladder, the controller being configured to control the force application element in response to the signal.

[0024] In some embodiments, the sensor includes a pressure sensor configured to couple to the conduit to sense pressure within the conduit, the signal being indicative of the pressure.

[0025] In some embodiments, the conduit includes an expandable portion configured to expand as urine flows into the expandable portion; The sensor is configured to sense a degree of expansion of the expandable portion; The signal indicates the degree of expansion.

[0026] In some embodiments, the expandable portion includes a reservoir disposed upstream from the portion of the conduit where the force is applied.

[0027] In some embodiments, the expandable portion includes a movable wall and is configured to expand via movement of the movable wall, and the force applying element is configured to apply a force to the movable wall.

[0028] In some embodiments, the sensor includes a pressure sensor configured to sense a pressure that varies depending on the degree of inflation.

[0029] In some embodiments, the sensor includes an optical sensor configured to sense the degree of expansion by emitting light at the expandable portion.

[0030] In some embodiments, the conduit is coupled to a first electrical interface configured to connect to the sensor and the force imparting element is coupled to a second electrical interface connected to a controller, and is configured to contact the first electrical interface such that when the force imparting element is coupled to the conduit, the sensor communicates a signal to the controller via the first electrical interface and the second electrical interface.

[0031] In some embodiments, the apparatus further includes a pressure transmission tube coupled to the conduit and configured to contain a fluid such that a fluid pressure of the fluid varies with an internal pressure within the conduit; the sensor includes a pressure sensor configured to couple to the pressure transmission tube to sense a fluid pressure; The signal is indicative of the fluid pressure.

[0032] In some embodiments, the device further includes an optical sensor configured to sense a visual parameter of the urine and communicate a signal indicative of the visual parameter to the controller.

[0033] Further, in accordance with some embodiments of the present invention, there is provided a method for use with a conduit configured to convey urine downstream from a subject's bladder, the method including controlling one or more force imparting elements reversibly coupled to the conduit, such that the force imparting elements apply a force to the conduit, thereby urging urine in a downstream direction from the conduit, and calculating an amount of urine urged based on controlling the force imparting elements.

[0034] Further, in accordance with some embodiments of the present invention, there is provided an apparatus for use with one or more force application elements, the apparatus including at least one tube configured to carry urine flowing downstream from a subject's bladder through a urinary catheter catheterizing the subject, the apparatus further including a conduit section coupled to the tube in fluid communication therewith and configured to reversibly couple to the force application element to facilitate the force application element applying a force to the conduit section, thereby urging urine downstream from the conduit section.

[0035] In some embodiments, the at least one tube comprises an upstream tube connected to an upstream end of the conduit section, the apparatus further comprising: a bypass tube connected to the upstream tube; and A valve comprising: preventing urine flow through the bypass tube when pressure in the bypass tube is below a predetermined threshold; allowing urine to bypass the conduit section when the pressure exceeds a threshold; a valve configured to:

[0036] In some embodiments, the at least one tube further comprises a downstream tube connected to a downstream end of the conduit section; The device further includes a connector configured to connect the downstream tube to a urine collection bag; The bypass tube is connected to the connector such that the bypass tube passes between the upstream tube and the connector.

[0037] In some embodiments, the valve is integrated into the connector.

[0038] In some embodiments, the force imparting element is coupled to the case, and the conduit section is configured to reversibly couple to the force imparting element by reversibly coupling to the case.

[0039] In some embodiments, the device further comprises a cartridge containing the conduit section.

[0040] In some embodiments, The case is formed to define a slot; The conduit section is configured to reversibly couple to the case via insertion of the cartridge into the slot.

[0041] In some embodiments, the device further includes one or more latches coupled to the conduit section and configured to latch to the case, thereby reversibly coupling the conduit section to the case.

[0042] In some embodiments, the apparatus further comprises a housing that accommodates the conduit section; the case includes one or more latches configured to latch to the housing; The conduit section is configured to reversibly couple to the case by the latches latching to the housing.

[0043] In some embodiments, the force applying element comprises a pressing element configured to apply a force to the conduit section by pressing against the conduit section.

[0044] In some embodiments, the conduit section includes a peristaltic pump tube, and the conduit section is configured to reversibly couple to a pushing element to facilitate the pushing element pushing against the peristaltic pump tube.

[0045] In some embodiments, the conduit section includes a chamber including a movable wall, and the conduit section is configured to reversibly couple to the force imparting element to facilitate the force imparting element applying a force to the movable wall.

[0046] In some embodiments, the apparatus further comprises a reservoir disposed upstream from the conduit section.

[0047] In some embodiments, the reservoir is configured to expand as urine flows into the reservoir.

[0048] In some embodiments, the device further includes a sensor configured to deliver a signal that varies depending on the amount of urine in the reservoir.

[0049] In some embodiments, the device further comprises a sensor configured to deliver a signal that varies depending on the amount of urine in the conduit section.

[0050] In some embodiments, the device further includes a pressure sensor configured to sense an outlet pressure at the outlet of the urinary catheter and communicate a signal indicative of the outlet pressure.

[0051] In some embodiments, the device further comprises a connection port coupled to the tube or conduit section and configured to couple to a pressure sensor such that the pressure sensor senses the internal pressure within the tube or conduit section.

[0052] In some embodiments, the device further includes a connection port coupled to the tube or conduit section and configured to couple to a pressure-conveying tube containing a fluid such that the fluid pressure in the pressure-conveying tube varies in response to the internal pressure in the tube or conduit section.

[0053] In some embodiments, the apparatus further comprises a pressure transmission tube.

[0054] In some embodiments, the apparatus further includes a first electrical interface coupled to the conduit and configured to connect to the sensor, and the force-imparting element is configured to be coupled to a second electrical interface connected to the controller and configured to contact the first electrical interface such that when the conduit section is coupled to the force-imparting element, the sensor communicates a signal to the controller via the first electrical interface and the second electrical interface.

[0055] Further, in accordance with some embodiments of the present invention, there is provided a system including a pump and a controller configured to control the pump to pump urine from the subject's bladder and to generate an alert indicative of a current or likely upcoming disruption to the pumping.

[0056] In some embodiments, the disruption comprises an inhibited flow of urine downstream from the pump.

[0057] In some embodiments, the controller is configured to generate an alert in response to an increase in the amount of power consumed by the pump.

[0058] In some embodiments, The controller is further configured to calculate a volume of urine pumped by the pump; The controller is configured to pump urine into a collection bag; The controller is configured to generate an alert in response to a difference between the maximum capacity of the collection bag and the amount of urine pumped being less than a predefined threshold.

[0059] In some embodiments, the disruption comprises an inhibited flow of urine upstream from the pump.

[0060] In some embodiments, the controller is configured to pump urine through a conduit connected to a urinary catheter that catheterizes the subject, and the obstructed flow is due to an obstruction in the conduit or urinary catheter upstream from the pump.

[0061] In some embodiments, The conduit includes a reservoir; The blockage is downstream of the reservoir. The controller is configured to generate an alert in response to a signal indicating that the amount of urine flowing from the reservoir is less than the pumping rate of the pump.

[0062] In some embodiments, a pressure sensor coupled to the conduit to sense pressure; The blockage is downstream from the pressure sensor. The controller is configured to generate an alert in response to a change in pressure.

[0063] In some embodiments, The conduit includes a reservoir; The blockage is upstream from the reservoir. The controller is configured to generate an alert in response to a signal indicating an increase in the volume of urine in the reservoir below a predefined threshold.

[0064] In some embodiments, a pressure sensor coupled to the conduit to sense pressure; The blockage is upstream from the pressure sensor. The controller is configured to generate an alert in response to the pressure increase being less than a predefined threshold.

[0065] Further, in accordance with some embodiments of the present invention, a method is provided for controlling a pump to pump urine from a subject's bladder, and for generating an alert indicating a current or upcoming disruption to the pumping.

[0066] Further, in accordance with some embodiments of the present invention, there is provided a system including a pump and a controller configured to continuously receive a signal that varies in response to an amount of urine in the subject's bladder or in a conduit connected to a urinary catheter catheterizing the subject, and in response to the signal, to pump urine using the pump through the conduit to maintain the amount of urine in the bladder within 20 ml.

[0067] In some embodiments, the controller is configured to pump urine through the conduit such that the amount of urine in the bladder remains below 20 ml.

[0068] In some embodiments, the controller is configured to pump urine through the conduit to maintain a pressure within the conduit below atmospheric pressure.

[0069] In some embodiments, the signal is indicative of pressure in the conduit.

[0070] In some embodiments, the signal is indicative of a fluid pressure of a fluid contained within a tube coupled to the conduit.

[0071] In some embodiments, the conduit includes an expandable portion configured to expand as urine flows into the expandable portion, and the signal indicates a degree of expansion of the expandable portion.

[0072] In some embodiments, the controller is configured to activate the pump in response to a signal exceeding a predefined threshold.

[0073] In some embodiments, the controller is configured to activate the pump in response to a signal exceeding a predefined threshold in a first direction, and the controller is further configured to stop the pump in response to a signal exceeding a predefined threshold in a second direction opposite the first direction.

[0074] In some embodiments, the predefined threshold is a first predefined threshold, The controller is configured to stop the pump in response to the signal exceeding a first predefined threshold in the second direction and then exceeding a second predefined threshold in the second direction.

[0075] In some embodiments, the controller is further configured to stop the pump in response to the pump pumping a predefined amount of urine.

[0076] Further, in accordance with some embodiments of the present invention, there is provided a method including continuously receiving a signal that varies in response to the amount of urine in the subject's bladder or in a conduit connected to a urethral catheter catheterizing the subject, and in response to the signal, using a pump to pump urine through the conduit to maintain the amount of urine in the bladder within 20 ml.

[0077] Further, in accordance with some embodiments of the present invention, there is provided a system including a display and a processor configured to obtain a noisy signal representative of a rate of urine production by the kidneys of a subject as a function of time, filter noise from the noisy signal to obtain a clean signal, calculate a representative rate of change of the clean signal over a period of at least 12 hours, and display an output indicative of the representative rate of change on a display.

[0078] In some embodiments, the output includes a graphical output.

[0079] In some embodiments, the processor is further configured to generate an alert in response to a magnitude of the representative rate of change exceeding a predefined threshold.

[0080] Further, in accordance with some embodiments of the present invention, there is provided a method comprising obtaining a noisy signal representative of a rate of urine production by the kidneys of a subject as a function of time, filtering noise from the noisy signal to obtain a clean signal, calculating a representative rate of change of the clean signal over a period of at least 12 hours, and generating an output indicative of the representative rate of change.

[0081] Further, in accordance with some embodiments of the present invention, there is provided a system including a conduit configured to connect to a urinary catheter for catheterizing a subject, and a controller configured to determine that flow of urine downstream from the subject's bladder through the conduit has at least partially ceased, and to increase pressure within the conduit in response to the determination.

[0082] In some embodiments, the controller is configured to increase the pressure by forcing urine to flow upstream towards the bladder.

[0083] In some embodiments, the controller is configured to increase the pressure by pushing on the conduit.

[0084] In some embodiments, the system further includes a plunger, and the controller is configured to push the conduit using the plunger.

[0085] In some embodiments, the controller further comprises: Check that urine flow from the bladder has resumed. Once you have confirmed that urine flow from the bladder has resumed, stop increasing the pressure. It is configured as follows.

[0086] In some embodiments, the system further comprises a pump, and the controller further comprises: A pump is used to pump urine downstream, Upon confirmation, stopping pumping urine downstream; It is configured as follows.

[0087] In some embodiments, the controller is configured to increase the pressure by operating the pump in an upstream pumping direction.

[0088] In some embodiments, the controller is further configured to resume pumping urine downstream in response to determining that urine has resumed flow from the bladder.

[0089] Further, in accordance with some embodiments of the present invention, a method is provided that includes confirming that urine has at least partially stopped flowing downstream from the subject's bladder through a conduit connected to a urinary catheter that catheterizes the subject, and increasing pressure in the conduit in response to the confirmation.

[0090] Further, in accordance with some embodiments of the present invention, there is provided a system including a display and a controller configured to empty a subject's bladder by pumping urine from the bladder, calculate an estimated amount of time required for a predefined amount to flow into the bladder after the bladder has emptied, receive a signal that varies as a function of pressure in the bladder after the estimated time after the bladder has emptied, ascertain the pressure in the bladder based on the signal, and display an output on a display indicating that the pressure in the bladder is the intra-abdominal pressure of the subject.

[0091] In some embodiments, the controller is configured to pump urine through a urinary catheter that catheterizes the subject, and the signal is generated by a pressure sensor coupled to the urinary catheter.

[0092] In some embodiments, the controller is configured to calculate the estimated time based on the amount of urine pumped during the previous period.

[0093] In some embodiments, the controller further comprises: Re-emptying the bladder, and Verifying that the amount of urine pumped from the bladder during re-emptying deviates from a predefined volume by less than a predefined threshold; and further configured to verify that the pressure in the bladder is intraperitoneal pressure by: The controller is configured to display an output in response to the validation.

[0094] Further, in accordance with some embodiments of the present invention, there is provided a method including emptying a subject's bladder by pumping urine from the bladder, calculating an estimated time since the bladder has been emptied that is required for a predetermined volume to flow into the bladder after the estimated time since the bladder has been emptied, receiving a signal that varies as a function of pressure in the bladder based on that signal, ascertaining the pressure in the bladder, and generating an output indicative of the pressure in the bladder being the intra-abdominal pressure of the subject.

[0095] Further, in accordance with some embodiments of the present invention, there is provided a fluid conduit including a first tube configured to transport urine downstream from the subject's bladder, the fluid conduit including one or more flexible walls configured to collapse within the first tube as pressure in the first tube decreases until the first tube is closed, and a second tube coupled to the first tube and configured to transport urine downstream from the first tube.

[0096] In some embodiments, the flexible wall comprises: a first wall including a first surface; and and a second wall including a second surface joined to the first surface at opposing edges of the first surface such that as pressure is reduced, the first wall and the second wall collapse toward each other until the first surface and the second surface are in full contact with each other between the edges.

[0097] In some embodiments, the upstream portion of the flexible wall is more flexible than the downstream portion of the flexible wall.

[0098] Further, in accordance with some embodiments of the present invention, a kit for fluid collection is provided, the kit including a tube having an upstream end for receiving fluid output by a subject and having a downstream end, and a non-spill connector secured to the downstream end of the tube to prevent fluid from flowing out and configured to connect to a mating connector coupled to a fluid collection bag, such that insertion of the mating connector into the non-spill connector opens the non-spill connector, thereby allowing fluid to flow out of the tube through the connector and the mating connector and into the fluid collection bag.

[0099] In some embodiments, the upstream end of the tube is configured to receive urine from a urinary catheter.

[0100] In some embodiments, the non-spill connector includes a plurality of flexible leaves that close together across the non-spill connector.

[0101] In some embodiments, the plurality of flexible leaves comprises a section of a polymer diaphragm that extends across the non-spill connector.

[0102] In some embodiments, the kit further includes a mating connector and a fluid collection bag, the fluid collection bag coupled to the mating connector to receive and store fluid exiting the tube.

[0103] Further, in accordance with some embodiments of the present invention, there is provided a fluid collection device that includes a connector having an upstream end for connecting to a urinary catheter and having a downstream end, a tube coupled to the downstream end of the connector for receiving urine flowing through the catheter, and a temperature sensor configured to estimate a temperature of the urine flowing into the connector.

[0104] In some embodiments, the temperature sensor is operatively associated with the connector.

[0105] In some embodiments, the temperature sensor is configured to output an electrical signal indicative of the temperature of the urine, and the device includes wires connected to the temperature sensor to transmit the electrical signal to the measurement circuitry.

[0106] In some embodiments, the temperature sensor is configured to output a pressure indicative of the temperature of the urine, and the device includes a capillary tube connected to the temperature sensor at an upstream end of the capillary tube and connected at its downstream end to a pressure measuring device that estimates the temperature in response to the pressure in the capillary tube.

[0107] In some embodiments, the device includes a means for controlling the flow of urine.

[0108] In some embodiments, the urine flow is stopped for a predefined period of time and the temperature is estimated at the end of that period.

[0109] In some embodiments, the predetermined time is calculated based on the amount of urine flowing through the connector during a predetermined period of time before stopping the urine flow.

[0110] Further, in accordance with some embodiments of the present invention, there is provided a pump that includes a pumping mechanism configured to propel fluid through a tube, and a release mechanism coupled to receive an indication of an anomaly in a fluid circuit to which the tube is connected, and to release fluid from the tube in response to the indication.

[0111] In some embodiments, the indication of the abnormality includes an increase in pressure in a tube at a location upstream of the pump.

[0112] In some embodiments, a portion of the tube is flexible, the pumping mechanism includes a plurality of rollers configured to roll against and press against the flexible portion of the tube, the pump includes a clamp configured to press the flexible portion of the tube against the pumping mechanism such that the rollers compress the tube, and in response to an instruction, the release mechanism is configured to release the clamp from the flexible portion of the tube.

[0113] In some embodiments, the release mechanism includes a movable rod having a first end in contact with the flexible portion of the tube, such that an indication of the abnormality causes movement of the rod, which releases the clamp.

[0114] In some embodiments, the pump further includes a spring connected to apply compression to the clamp to press the clamp against the flexible portion of the tube, and the release mechanism is configured to release the compression of the spring in response to an instruction.

[0115] In some embodiments, the release mechanism includes an electromechanical element configured to release fluid in response to an electrical signal indicative of the anomaly.

[0116] Further, in accordance with some embodiments of the present invention, there is provided a peristaltic pump that includes a flexible tube configured to receive fluid from a fluid source, a plurality of pushing elements configured to continuously push against a portion of the flexible tube, a clamp configured to push the portion of the flexible tube against the pushing elements such that the pushing elements compress the tube, and one or more springs coupled to apply compression between the pushing elements and the clamp such that the pushing elements apply a force against the portion of the flexible tube such that the force remains substantially constant regardless of variations in mechanical properties of components of the pump.

[0117] In some embodiments, the one or more springs include a linear spring.

[0118] In some embodiments, the one or more springs include a coil spring.

[0119] In some embodiments, the one or more springs are operatively associated with the clamp.

[0120] In some embodiments, one or more springs are coupled to shift the biasing element toward the clamp.

[0121] In some embodiments, the pump further includes a rotor including a rotating drum, the pushing element including a roller attached to the drum, and the one or more springs coupled to move the roller radially outward within the drum.

[0122] In some embodiments, the rollers are attached to respective rods configured to pivot about respective axes on the drum, and one or more springs are coupled to impart a rotational force to the rods about their respective axes.

[0123] In some embodiments, the one or more springs are attached to a rod.

[0124] In some embodiments, the one or more springs are attached to a roller.

[0125] In some embodiments, the rollers are mounted within respective radial slots in the drum such that compression applied by one or more springs causes the rollers to move radially within the radial slots.

[0126] In some embodiments, the rollers include rolling bearings disposed at each end of the rollers and configured to slide radially within the slots.

[0127] In some embodiments, the one or more springs are coupled to urge the rotor towards the clamp.

[0128] In some embodiments, the pump further includes a lock configured to enable one or more springs to drive the pushing element toward the clamp to a position where the pushing element applies a substantially constant force against the flexible tube upon insertion of the flexible tube into the pump, and then lock the pushing element in that position during operation of the pump.

[0129] In some embodiments, the pump further includes a lock configured to enable one or more springs to drive the clamp toward the pushing element to a position where the pushing element applies a substantially constant force against the flexible tube upon insertion of the flexible tube into the pump, and then lock the clamp in that position during operation of the pump.

[0130] Further, in accordance with some embodiments of the present invention, there is provided a fluid collection or delivery device including a hanger configured to hold the fluid bag while the fluid bag receives fluid drained from a subject's body or perfuses fluid into the body such that the fluid bag is suspended from the hanger, and a sensor coupled to the hanger and configured to sense an amount of fluid in the fluid bag.

[0131] In some embodiments, the fluid bag is coupled to receive urine from the urinary catheter.

[0132] In some embodiments, the sensor is configured to measure a weight of fluid in the fluid bag.

[0133] In some embodiments, the sensor is configured to measure the level of fluid in the fluid bag.

[0134] In some embodiments, the device further includes a controller configured to issue an alarm when the amount of fluid reaches a predefined limit.

[0135] In some embodiments, the device further includes a communications link coupled to communicate an indication of the sensed amount of fluid to the receiver.

[0136] In some embodiments, the device further includes a monitoring system configured to receive an indication of the sensed amount and to calculate and display information regarding the output of fluid by or delivery of fluid to the subject over time.

[0137] In some embodiments, the monitoring system is configured to display data regarding one or more additional fluids entering or leaving the subject's body.

[0138] In some embodiments, the monitoring system is configured to display data for multiple subjects simultaneously.

[0139] In some embodiments, the device further comprises a display.

[0140] The present invention will be more fully understood from the following detailed description of the embodiments thereof, taken in conjunction with the drawings. [Brief description of the drawings]

[0141] [Figure 1A] FIG. 1 is a schematic diagram of a peristaltic pump according to some embodiments of the present invention. [Figure 1B] 1 is a schematic diagram of a peristaltic pump tubing according to some embodiments of the present invention. [Figure 1C] 1 is a schematic diagram of a peristaltic pump mechanically coupled to a peristaltic pump tube, according to some embodiments of the present invention. FIG. [Diagram 2] 1 is a plot showing an example of an aging graph for a peristaltic pump tubing. [Figure 3A] 1A-1D are schematic diagrams of a urine reservoir in different states, according to some embodiments of the present invention. [Figure 3B] 1A-1D are schematic diagrams of a urine reservoir in different states, according to some embodiments of the present invention. [Figure 3C] 1A-1D are schematic diagrams of a urine reservoir in different states, according to some embodiments of the present invention. [Figure 4A] FIG. 1 is a schematic diagram of a urinary reservoir according to some embodiments of the present invention. [Figure 4B] FIG. 1 is a schematic diagram of a urinary reservoir according to some embodiments of the present invention. [Figure 4C] FIG. 1 is a schematic diagram of a urinary reservoir according to some embodiments of the present invention. [Figure 5A] 4A-C in different states, according to some embodiments of the present invention. [Figure 5B] 4A-C in different states, according to some embodiments of the present invention. [Figure 5C] 4A-C in different states, according to some embodiments of the present invention. [Figure 6A] 1A-1D are schematic diagrams of longitudinal cross sections through a urinary reservoir in different states according to some embodiments of the present invention. [Figure 6B] 1A-1D are schematic diagrams of longitudinal cross sections through a urinary reservoir in different states according to some embodiments of the present invention. [Figure 6C] 1A-1D are schematic diagrams of longitudinal cross sections through a urinary reservoir in different states according to some embodiments of the present invention. [Figure 7A] 1A-1C are schematic diagrams of an optical sensor operatively coupled to a urine reservoir, according to various different embodiments of the present invention. [Figure 7B] 1A-1C are schematic diagrams of an optical sensor operatively coupled to a urine reservoir, according to various different embodiments of the present invention. [Figure 7C] 1A-1C are schematic diagrams of an optical sensor operatively coupled to a urine reservoir, according to various different embodiments of the present invention. [Figure 8A] 1A-1C are schematic diagrams of an optical sensor operatively coupled to a urine reservoir, according to various different embodiments of the present invention. [Figure 8B]1A-1C are schematic diagrams of an optical sensor operatively coupled to a urine reservoir, according to various different embodiments of the present invention. [Figure 8C] 1A-1C are schematic diagrams of an optical sensor operatively coupled to a urine reservoir, according to various different embodiments of the present invention. [Figure 9] 1A-1C are schematic diagrams of an optical sensor operatively coupled to a urine reservoir, according to various different embodiments of the present invention. [Figure 10A] 1A-1C are schematic diagrams of an optical sensor operatively coupled to a urine reservoir, according to various different embodiments of the present invention. [Figure 10B] 1A-1C are schematic diagrams of an optical sensor operatively coupled to a urine reservoir, according to various different embodiments of the present invention. [Figure 10C] 1A-1C are schematic diagrams of an optical sensor operatively coupled to a urine reservoir, according to various different embodiments of the present invention. [Figure 11A] 1 is a schematic diagram of a contact sensor operably coupled to a urine reservoir, according to some embodiments of the present invention. FIG. [Figure 11B] 1 is a schematic diagram of a contact sensor operably coupled to a urine reservoir, according to some embodiments of the present invention. FIG. [Figure 12A] 1 is a schematic diagram of a disposable kit according to various different embodiments of the present invention. [Figure 12B] 1 is a schematic diagram of a disposable kit according to various different embodiments of the present invention. [Figure 13] 1 is a schematic diagram of a disposable kit according to various different embodiments of the present invention. [Figure 14] 1 is a schematic diagram of a catheter connector, according to some embodiments of the present invention. [Figure 15] FIG. 1 is a schematic diagram of a dual-lumen tube, according to some embodiments of the present invention. [Figure 16] 1 is a schematic diagram of the operation of a urine pumping system according to some embodiments of the present invention. [Figure 17]17 shows a flow diagram for the operation of the urine pumping system according to FIG. 16, according to some embodiments of the present invention. [Figure 18] FIG. 2 illustrates a flow diagram for a control algorithm executed by a controller according to some embodiments of the present invention. [Figure 19] 4 is an exemplary plot of a sensor signal as a function of time according to some embodiments of the present invention. [Figure 20] 1 is a schematic diagram of a urine pumping system, according to some embodiments of the present invention. [Figure 21] 21 is a schematic diagram of a disposable kit according to FIG. 20, according to some embodiments of the present invention. [Figure 22] 1 is a schematic diagram of a urine pumping system, according to some embodiments of the present invention. [Figure 23] 23 is a schematic diagram of a disposable kit according to FIG. 22, according to some embodiments of the present invention. [Figure 24A] 1 is a schematic diagram of a pressure valve, according to some embodiments of the present invention. [Figure 24B] 1 is a schematic diagram of a pressure valve, according to some embodiments of the present invention. [Figure 24C] 1 is a schematic diagram of a pressure valve, according to some embodiments of the present invention. [Figure 24D] 1 is a schematic diagram of a cross section through a prior art tube in an inflated and deflated state. [Figure 24E] 1 is a schematic diagram of a cross section through a pressure valve tube, according to some embodiments of the present invention. [Diagram 25] 1A-1D are schematic diagrams of urine pumping systems according to different respective embodiments of the present invention. [Figure 26] 1A-1D are schematic diagrams of urine pumping systems according to different respective embodiments of the present invention. [Figure 27] 1A-1D are schematic diagrams illustrating exemplary performance of suction relief according to some embodiments of the present invention. [Figure 28] 1 is a schematic diagram of a urine pumping system, according to some embodiments of the present invention. [Figure 29] 1 shows a flow diagram of an algorithm for measuring intra-abdominal pressure according to some embodiments of the present invention. [Diagram 30] 1 is a schematic diagram of a urine pumping system, according to some embodiments of the present invention. [Diagram 31] FIG. 1 illustrates a block diagram of some components of a urine pumping system, according to some embodiments of the present invention. [Diagram 32] 4 illustrates a flow diagram of a control and warning algorithm executed by a controller according to some embodiments of the present invention. [Diagram 33] 13 shows a plot tracking reservoir volume over time according to some embodiments of the present invention. [Figure 34A] 1 is a schematic side view of a replaceable fluid bag with a non-spill connector, according to some embodiments of the present invention. [Figure 34B] FIG. 34B is a schematic detail view of the non-spill connector of FIG. 34A. [Figure 34C] FIG. 34B is a schematic front view of the non-spill connector of FIG. 34A in a closed configuration. [Fig. 34D] FIG. 34B is a schematic front view of the non-spill connector of FIG. 34A in an open configuration. [Diagram 35] 4A-4C are schematic diagrams of example display outputs according to some embodiments of the present invention. [Figure 36A] FIG. 1 is a schematic side view of a peristaltic pump with a spring-loaded safety release in a conventional configuration, according to some embodiments of the present invention. [Figure 36B] FIG. 1 is a schematic side view of a peristaltic pump with a spring-loaded safety release in an released configuration, according to some embodiments of the present invention. [Figure 37] FIG. 1 is a schematic diagram of a disposable kit having a pressure regulating bypass tube, according to some embodiments of the present invention. [Figure 38] 1 is a schematic side view of a spring used to control the pressure applied by a clamp of a peristaltic pump, according to some embodiments of the present invention. [Figure 39A] FIG. 1 is a schematic side view of a peristaltic pump with a spring-loaded pressure clamp, in accordance with an embodiment of the present invention. [Figure 39B] FIG. 2 is a schematic side view of a peristaltic pump with a spring-loaded pressure clamp, in accordance with an embodiment of the present invention. [Figure 39C] FIG. 2 is a schematic side view of a peristaltic pump with a spring-loaded pressure clamp, in accordance with an embodiment of the present invention. [Diagram 40] FIG. 1 is a schematic side view of a catheter tube connector with an integrated temperature sensor, according to some embodiments of the present invention. [Diagram 41] 1 is a schematic side view of a spring-loaded roller of a peristaltic pump, according to some embodiments of the present invention. FIG. [Diagram 42] FIG. 13 is a schematic pictorial representation of a spring-loaded roller of a peristaltic pump according to another embodiment of the present invention. [Diagram 43] FIG. 13 is a schematic side view of a spring-loaded roller of a peristaltic pump in accordance with yet another embodiment of the present invention. [Figure 44A] 1 is a schematic detail view of a roller of a peristaltic pump with spring-loaded rolling bearings, according to some embodiments of the present invention. FIG. [Figure 44B] 1 is a schematic perspective view of a spring-loaded roller of a peristaltic pump according to a further embodiment of the present invention; FIG. [Figure 45A] FIG. 13 is a schematic diagram of a peristaltic pump with spring-loaded rollers according to yet another embodiment of the present invention. [Figure 45B] FIG. 13 is a side view of a peristaltic pump with spring-loaded rollers according to yet another embodiment of the present invention. [Figure 46A] FIG. 1 is a schematic side view of a peristaltic pump with a replaceable cartridge before the cartridge is attached to the pump, according to some embodiments of the present invention. [Figure 46B] 1 is a schematic side view of a peristaltic pump with a replaceable cartridge after the cartridge has been installed in the pump, according to some embodiments of the present invention. [Figure 47A] FIG. 1 is a schematic side view of a urine collection bag hanging scale, according to some embodiments of the present invention. [Figure 47B] FIG. 47B is a schematic detail view of the balance of FIG. 47A. [Figure 47C] FIG. 47B is a schematic detailed view of a controller integrated into the hanging balance of FIG. 47A. [Figure 47D] FIG. 47D is a block diagram that illustrates a schematic of the circuitry within the controller of FIG. 47C. [Figure 48] 1 is a schematic diagram of a display screen illustrating a fluid management dashboard, according to some embodiments of the present invention. [Figure 49] 1 is a schematic diagram of a system for displaying urine production parameters, according to some embodiments of the present invention. [Figure 50] 1 is a schematic diagram of a urine pumping system according to different embodiments of the present invention. [Figure 51] 1 is a schematic diagram of a urine pumping system according to different embodiments of the present invention. [Figure 52A] 2A-2C are schematic diagrams of conduit sections according to different embodiments of the present invention. [Figure 52B] 2A-2C are schematic diagrams of conduit sections according to different embodiments of the present invention. [Diagram 53] 3A-3C are schematic diagrams of a control unit according to different embodiments of the present invention; [Figure 54] 3A-3C are schematic diagrams of a control unit according to different embodiments of the present invention; [Figure 55] FIG. 2 is a schematic diagram of a control unit connected to a power box according to some embodiments of the present invention. [Figure 56] 2 is a schematic diagram of a display output according to some embodiments of the present invention. [Figure 57] FIG. 2 is a schematic diagram of a control unit according to some embodiments of the present invention. [Figure 58] 1 is a schematic diagram of a urine pumping system, according to some embodiments of the present invention. [Figure 59] 3A-3C are schematic diagrams of a control unit according to different embodiments of the present invention; [Figure 60] 3A-3C are schematic diagrams of a control unit according to different embodiments of the present invention; [Figure 61] 1 is a schematic diagram of a urine pumping system, according to some embodiments of the present invention. [Figure 62] FIG. 2 is a schematic diagram of a control unit according to some embodiments of the present invention. [Figure 63A] 1 is a schematic diagram of a reciprocating pump and conduit sections according to various different embodiments of the present invention. [Figure 63B] 1 is a schematic diagram of a reciprocating pump and conduit sections according to various different embodiments of the present invention. [Fig. 64A] 1 is a schematic diagram of a reciprocating pump and conduit sections according to various different embodiments of the present invention. [Fig. 64B] 1 is a schematic diagram of a reciprocating pump and conduit sections according to various different embodiments of the present invention. [Figure 65] 1 is a schematic diagram of a urine pumping system, according to some embodiments of the present invention. [Figure 66A] FIG. 1 is a schematic diagram of a disposable kit for facilitating measurement of urine output and / or production, according to some embodiments of the present invention. [Figure 66B] FIG. 1 is a schematic diagram of a system for measuring urine output and / or production, according to some embodiments of the present invention. [Figure 67] 2 is a schematic diagram of a reciprocating pump and conduit sections according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0142] overview Embodiments of the invention include systems and methods for accurate, real-time measurement of a subject's urine output, i.e., the amount of urine voided from a subject's bladder, and / or urine production, i.e., the amount of urine produced by the subject's kidneys. Embodiments of the invention further include systems and methods for communicating and / or displaying urine output or production, or related parameters derived therefrom, such as the time-varying rate of urine production. Embodiments of the invention further include systems and methods for measuring other parameters, such as intra-abdominal pressure (IAP), core body temperature, and urinary optical parameters such as opacity.

[0143] In some embodiments, the urine pumping system is configured to measure a subject's urine output and / or production. The urine pumping system includes a disposable device, referred to herein as a "kit," and a non-disposable urine pumping device. The disposable kit is for one-time use and includes a urinary conduit configured to connect a urinary catheter (e.g., a Foley catheter) that catheterizes the subject's bladder to a urine collection bag. The urine pumping device includes a controller (i.e., control circuitry) configured to pump urine through the conduit using a positive displacement pump, typically such that the bladder remains substantially free of urine. Based on the pumping, the controller calculates the subject's urine output and / or urine production, and typically the rate of urine production for the subject. Optionally, the controller may display the rate (and / or other related parameters) of urine production and / or communicate the rate (and / or other related parameters) to one or more other devices or systems, such as a patient monitor, a nurse's station monitor, or an electronic medical record (EMR).

[0144] In general, any type of positive displacement pump may be used. Typically, a positive displacement pump includes one or more force applying elements configured to apply force to a conduit, thereby pumping urine through the conduit. At least some of these elements may belong to a non-disposable urine pumping device. In such an embodiment, the non-disposable force applying elements of the pump may be calibrated and the calibration parameters may be stored in a non-volatile memory within the device. Alternatively or additionally, at least some of the pump elements may belong to a disposable kit.

[0145] Typically, the force-imparting element comprises an actuator. In the context of this application, including the claims, the term "actuator" may include any device that uses power (e.g., electrical, mechanical, pneumatic, or hydraulic) supplied to the actuator to cause movement of another element.

[0146] For example, Figures 50-51, 58, and 61 show embodiments in which an actuator reversibly couples to a conduit and exerts a force on the conduit via a fluid (i.e., gas or liquid) contained in the tube. In these embodiments, the actuator converts the supplied power into pneumatic or hydraulic pressure, which in turn causes movement of a movable wall (Figures 50-51) or movement of a shaft (Figures 58 and 61) of the conduit.

[0147] Alternatively, the actuator may be coupled to a pushing element configured to push against the conduit (while in contact with the conduit) when actuated by the actuator, In such an embodiment, the actuator uses the supplied power to move the pushing element.

[0148] For example, in some embodiments, the conduit includes a peristaltic pump tube and the pushing element includes an array of rotors or linear translational elements configured to squeeze urine from the peristaltic pump tube in a desired direction when actuated by the actuator. In some such embodiments, to facilitate more accurate calculation of the urine flow rate, the system has one or more additional components (e.g., springs) that provide a pumping force applied to the peristaltic pump tube independent of manufacturing tolerances and / or wear over time in one or more components of the system. Such components may include the tube, a clamp that clamps the tube to the pushing element, and / or the pushing element.

[0149] As another example, as shown in FIGS. 63A-B and 64A-B, the conduit may have a pump chamber having a movable wall (e.g., a diaphragm or piston), and the pushing element may include a plunger configured to push against the movable wall when actuated by the actuator, thereby forcing urine from the pump chamber in the desired direction.

[0150] In some embodiments, the system further comprises a sensor for facilitating control of the pump. In particular, the sensor is configured to transmit a signal to the controller that varies depending on the amount of urine in the conduit or the subject's bladder, and the controller is configured to control the force application element of the pump in response to the signal. The sensor may include, for example, a pressure sensor, a volume sensor, an optical sensor (FIGS. 7-10), a capacitive sensor, a resistive sensor, an inductive sensor, an ultrasonic sensor, and / or a contact sensor (FIGS. 11A-B). The sensor may sense the displacement of the diaphragm, the expandable reservoir wall, or the wall of the other expandable portion of the conduit. The displacement may be sensed optically, resistively, capacitively, inductively, ultrasonically, contact, magnetically, or in any other suitable manner.

[0151] Capacitive sensors can be implemented in several ways. For example, a wall or diaphragm can be coated with a conductive material that acts as one plate of a capacitor, another plate can be fixed near the first plate, and both plates can be electrically connected to a circuit that measures the capacitance. When the wall or diaphragm is displaced, the distance between the plates and therefore the capacitance changes, making the capacitance an indication of the displacement.

[0152] In some embodiments, the capacitor belongs to an oscillator, so that the frequency of the oscillator depends on the capacitance of the capacitor. By measuring the frequency of the oscillator (e.g., by counting the number of cycles per given period), the capacitance of the capacitor can be ascertained.

[0153] Resistive sensors can also be implemented in several ways. For example, the wall or diaphragm can be coated with a resistive material and electrically connected at two opposite edges to an electrical circuit such that the wall or diaphragm acts as a resistor in the circuit. The resistance of the resistor can be determined in a similar manner as described above for capacitive sensors (e.g., by determining the frequency of an oscillator). When the wall or diaphragm is displaced, the resistance between the two opposite contacts changes because the wall or diaphragm stretches. The change in resistance is therefore indicative of the displacement of the wall or diaphragm.

[0154] Inductive sensors can be implemented in several ways. For example, a wall or diaphragm can be coated with a ferromagnetic material and placed on the back of a coil that can belong to an electric circuit. When the wall or diaphragm is displaced, the inductance of the coil changes, so that the inductance indicates the displacement of the wall or diaphragm. The inductance of the coil can be determined in a similar manner as described above for capacitive sensors (e.g., by determining the frequency of an oscillator).

[0155] In some embodiments, the sensor comprises an ultrasonic transducer placed near a wall or diaphragm, and the round trip delay of the ultrasonic signal (wave) can be measured to determine the distance from the transducer to the wall or diaphragm.

[0156] The magnetic sensor may comprise a magnetometer and the wall or diaphragm may be coated with a metallic material, the displacement of the wall or diaphragm being ascertained from the strength of the magnetic field measured by the magnetometer.

[0157] In some embodiments, the conduit includes an expandable portion configured to expand as urine flows into the expandable portion. The sensor is configured to sense the degree of expansion of the expandable portion and communicate a signal indicative of the degree of expansion to the controller. For example, a pressure sensor may sense pressure from the expandable portion or a portion of the conduit near the expandable portion that varies with the degree of expansion, such as pressure in a fluid-filled tube or chamber separated by a flexible diaphragm. As another example, an optical sensor may sense the amount of light reflected from the expandable portion, which varies with the degree of expansion. In response to the degree of expansion, the controller controls a force application element of the pump.

[0158] In some such embodiments, the expandable portion has a urine reservoir disposed upstream from the portion of the conduit where force is applied by the force-applying element. The reservoir may have at least one moveable (e.g., flexible) wall, the position and / or shape of which changes depending on the amount of urine in the reservoir. Optionally, the reservoir and pump may be manufactured together as part of a single, integrated disposable unit.

[0159] In other such embodiments (e.g., as shown in Figs. 50-51, 52A-B, 63A-B, and 64A-B), the expandable portion has a pump chamber including a movable wall, such as a diaphragm or piston, against which a force is applied by a force applying element, and the pump chamber is configured to expand due to movement of the movable wall as urine flows into the pump chamber.

[0160] Typically, the controller is contained in a control unit that may be conveniently coupled to the subject's bedside. The other components of the urinary pumping device may be housed in the control unit or may be housed remotely therefrom.

[0161] In some embodiments, the control unit also has a pump pushing element. In such embodiments, a portion of the conduit may be coupled (e.g., inserted) into the control unit such that the conduit is coupled to the pushing element. Optionally, the coupled (e.g., inserted) portion of the conduit may have a reservoir, and the control unit may have a sensor configured to monitor the reservoir.

[0162] In other embodiments, the control unit includes an actuator for the pump, but the pushing element is external to the control unit. Alternatively, the pump may lack a pushing element, in that the actuator may pump urine by applying pneumatic or hydraulic pressure to a conduit. In such embodiments, the actuator may be coupled to the pushing element or the conduit via wires and / or tubes.

[0163] For example, a pumping force may be applied to the conduit via a fluid-filled tube. Optionally, the control unit may further comprise a pressure sensor connected to the tube, and the controller may control the pumping force in response to pressure sensed by the pressure sensor when no pumping force is applied. Thus, advantageously, a single tube may be used for both sensing and pumping (alternately).

[0164] In yet other embodiments, the actuators are external to the control unit and are powered via electrical wiring exiting the control unit.

[0165] In general, pumps may be actuated electrically, hydraulically or pneumatically, or by mechanical force. The pump actuator may include, for example, a motor (e.g., an electric, hydraulic, or pneumatic motor), a solenoid, or a hydraulic or pneumatic piston.

[0166] In some embodiments, instead of a reservoir as described above, the conduit has a thin membrane (also referred to herein as a "diaphragm") coupled to the inlet of the pump chamber, which is deflected as urine enters or leaves the pump chamber. In such embodiments, the pressure sensor may measure the fluid pressure, i.e., air pressure or oil pressure, that changes as the membrane deflects. Alternatively, an optical sensor may sense the deflection of the membrane by emitting light at the membrane.

[0167] In some embodiments, the urine pumping device and / or disposable kit further includes a sensor (e.g., a pressure sensor) coupled to the inlet of the pump and / or a sensor (e.g., a pressure sensor) coupled to the outlet of the pump. In such embodiments, the controller may control the pump in response to a signal from either of these sensors.

[0168] In some embodiments, the disposable kit has a machine-readable data storage medium, such as a bar code, a quick response (QR) code, volatile memory, non-volatile memory (e.g., flash memory, read only memory (ROM), or electrically erasable programmable read only memory (EEPROM)), radio frequency identification (RFID) tag, flash memory, and / or machine-readable printing or engraving. The data storage medium may store various parameters, such as pump tubing characteristics, calibration parameters, security parameters, subject-specific parameters (e.g., subject ID), or measurements. Some of these parameters (e.g., pump tubing characteristics) may be stored, printed, or engraved during manufacture of the disposable kit.

[0169] In some embodiments, the controller is configured to generate an alert, for example, as described below with reference to Figure 32. For example, the controller may generate an alert indicating that urine flow upstream or downstream from the pump is obstructed, that the urine collection bag is nearly full, or that the pump has failed.

[0170] In some embodiments, the system includes a suction-relief mechanism configured to relieve the bladder from excessive suction forces that would cause bladder tissue to be sucked into the urinary catheter. In some such embodiments, the suction-relief mechanism includes a pushing element, such as a plunger, configured to squeeze a portion of the conduit upstream from the pump. To facilitate this squeezing, this portion of the conduit may be more flexible than other portions of the conduit, for example, by having a thinner wall.

[0171] In other embodiments, suction relief is accomplished by operating the pump in the reverse (upstream) pumping direction.

[0172] In some embodiments, the urine pumping device includes one or more batteries, which may be rechargeable or non-rechargeable, that may power the control unit when the control unit is disconnected from a main power source, for example, when the subject is moved to another bed or when an internal image is taken.

[0173] For embodiments in which the battery is rechargeable, the system may include a battery charging circuit configured to charge the battery when the control unit is connected to a mains power source. The battery charging circuit may also verify the battery charge level, monitor the battery temperature, and adjust charging accordingly if the temperature is too high. Alternatively or additionally, the battery charger may monitor the condition of the battery and send a signal to the controller when the battery needs replacing.

[0174] Alternatively or additionally, the urine pumping device may have a power source for powering all system components. In some such embodiments, the power source is integral with the control unit. In other such embodiments, the power source is separate from the control unit and connected to the control unit by an electrical cable. For example, the power source may be in a box configured to couple to a wall. Optionally, the power source box may include communication circuitry and / or communication ports, and the cable may include communication wires in addition to the power wires. An advantage of the communication circuitry and / or ports belonging to the power source box rather than the control unit is that it is relatively simple to connect or disconnect the control unit when moving the bed or replacing the control unit, given that only a single cable is connected to the control unit.

[0175] In general, the controller may be configured to perform a variety of tasks. For example, the controller may be configured to communicate with, calibrate, and / or control sensors upstream or downstream of the pump. Alternatively or additionally, the controller may control a pump actuator, a suction relief mechanism, and / or a battery charger. Alternatively or additionally, the controller may control a display, display data on a display, control a touch screen, and / or receive commands from a touch screen. Alternatively or additionally, the controller may communicate with one or more external devices or systems, such as a patient monitor, an EMR, or a device of the subject's physician (e.g., a cell phone or tablet).

[0176] More specifically, in some embodiments, the controller is configured to execute a pumping algorithm according to which the controller determines when to activate the pump and, optionally, how much urine to pump during each activation. The controller is further configured to record the number of strokes pumped during each activation and calculate the amount of urine pumped based on various parameters, such as the number of strokes pumped during the activation, the number of strokes previously pumped into the conduit, the elapsed time between strokes, the total duration of the strokes, the ambient temperature, the temperature of the urine, the pump inlet pressure, the pump outlet pressure, calibration parameters, and / or manufacturing parameters of the conduit. For example, in the case of a rotary peristaltic pump, the pumped volume may be calculated based on the number of rotations (including fractional rotations) of the pump rotor and the respective volume pumped during the rotation. In the case of a linear peristaltic pump, the pumped volume may be calculated based on the number of times a translational element of the pump is pressed against the pump tube. The controller may further calculate the instantaneous urine flow rate (which is generally equal to the instantaneous urine production rate, assuming the volume in the bladder remains relatively constant, i.e., within a relatively small range), by dividing the pumped volume by the time elapsed since the last pump actuation.

[0177] Alternatively, the controller may communicate basic pumping information (e.g., number and / or frequency of strokes performed and / or stroke volume) to another computer processor, which may calculate total urine production, urine production rate, and / or other relevant parameters.

[0178] In some embodiments, the controller activates the pump in response to determining, based on a signal from the sensor, that a pumping threshold has been reached. For example, based on a sensor signal, the controller may determine that a urine volume in the reservoir or a urine pressure in the conduit exceeds a predetermined value.

[0179] Optionally, after actuation of the pump, the controller may stop the pump in response to determining, based on the sensor signal, that a stop threshold has been reached. For example, the controller may determine, based on the sensor signal, that a urine volume or pressure in the reservoir is below a predetermined value. Alternatively, the controller may cause the pump to perform a predetermined number of strokes (the number of strokes may be based, for example, on the time elapsed since the most recent stroke), such that the pump stops after each stroke.

[0180] In yet other embodiments, the controller operates the pump to drive a parameter, such as the volume in the reservoir or the pressure in the conduit, as close as possible to a predetermined value. This may be done, for example, using a proportional-integral-derivative (PID) algorithm. In such embodiments, the pump volume may be calculated based on any of the parameters mentioned above (e.g., the number of strokes and the respective volume of each stroke) or based on the number and speed of rotation of the pump rotor.

[0181] When a series of multiple strokes is performed, the strokes may share the same motion profile; for example, in the case of a peristaltic pump, the rotor may accelerate during each stroke, be maintained at a constant speed, and then decelerate. Alternatively, some strokes may have different respective motion profiles to achieve more continuous pumping; for example, in the case of a peristaltic pump, the rotor may accelerate at the start of the first stroke, rotate at a constant speed (or a variable speed, e.g., according to a PID algorithm), and decelerate at the end of the last stroke.

[0182] In some embodiments, the controller is further configured to execute a suction relief algorithm according to which the controller determines when and how to execute suction relief, and executes suction relief, hi some embodiments, suction relief is executed when a pressure sensor upstream from the pump does not indicate a pressure increase for a predetermined period of time, indicating that urine flow through the catheter is likely blocked, for example, by bladder tissue.

[0183] In some embodiments, the controller is further configured to read data from the disposable kit. In some embodiments, these data include physical parameters of the conduit that the controller may use to calculate the volume of urine flow. For example, the controller may calculate the stroke volume based on the inner and outer diameters and stiffness of the peristaltic pump tubing. Alternatively or additionally, these data may include a disposable kit identifier (e.g., serial number) that the controller may use to associate the disposable kit with a particular subject. Thus, even if the disposable kit is disconnected from the control unit and later reconnected, the controller may identify the subject from whom urine is being pumped. Furthermore, if the control units in the hospital are configured to communicate the associated urine flow data to an EMR or other centralized information management system, the subject may be moved from the first control unit to the second control unit along with the subject's disposable kit, given that the second control unit may use the disposable kit identifier to retrieve the urine flow data calculated by the first control unit from the EMR.

[0184] In some embodiments, the controller is further configured to execute an IAP measurement algorithm, for example as described with reference to FIG.

[0185] In some embodiments, the controller is further configured to execute a filtering algorithm to filter noise from the urinary production signal, thereby generating a clean urine production signal, for example as described with reference to FIG. 49.

[0186] Alternatively or additionally, a sensor may be used to estimate the subject's IAP to facilitate control of pumping. Alternatively or additionally, pressure readings from a pressure sensor upstream of the pump and / or a pressure sensor downstream of the pump may be used to calculate urine flow, taking into account that pressure in the conduit upstream of the pump and / or downstream of the pump may affect pump stroke volume. Alternatively or additionally, sensor readings may be used to identify obstructions to urine flow upstream or downstream of the pump, for example due to blockage of the conduit or urinary catheter, or a full urine collection bag.

[0187] Instead of using a sensor, the pressure downstream of the pump can be estimated by measuring the current drawn by the pump actuator while pumping, as the amount of current increases with downstream pressure.

[0188] In some embodiments, the conduit comprises a tube with a single lumen for the urine flow. In other embodiments, the tube has two lumens, one for the urine flow and one for electrical wires that transmit power and / or signals between the control unit and other components such as pressure sensors, temperature sensors, or pump actuators. Alternatively, the second tube lumen may contain a gas or liquid (e.g., oil) for sensing pressure or temperature and / or for applying pneumatic or hydraulic force. Alternatively, the second tube lumen may contain a wire or thread for applying mechanical force to actuate the pump.

[0189] As another alternative, the tube may have three lumens: one for urine, one for transmitting power and / or signals or applying force (as described above), and a third lumen containing a fluid (i.e., gas or liquid) for pressure or temperature sensing.

[0190] As yet another alternative, the tube may have four lumens: one for urine, one for transmitting power and / or signals, one containing fluid for applying force, and a fourth containing fluid for pressure sensing.

[0191] In some embodiments, the disposable kit further includes any one or more of a urinary catheter, a catheter connector for connecting the urinary catheter to a conduit, a temperature sensor, a urine sampling port, and a urine collection bag. The urine collection bag may have a bottom valve for emptying the bag so that the bag does not need to be replaced. Alternatively or additionally, the collection bag may have an inlet connector that allows the bag to be disconnected from a complementary tubing connector (described immediately below), thereby facilitating replacement of the bag. In some embodiments, the urine collection bag further includes a one-way inlet valve that inhibits spillage of urine from the bag.

[0192] In some embodiments, the disposable kit has a tubing segment through which urine flows to a urine collection bag. The tubing segment may be permanently connected to the urine collection bag. Alternatively, the tubing segment may have a tubing connector at an end thereof, which may be configured to connect with the aforementioned inlet connector of the urine collection bag. In some embodiments, the tubing connector may have a non-spill connector that inhibits spillage of urine when the tubing segment is not connected to a bag.

[0193] It should be noted that in general, the disposable kit may include any of the system components described herein, even those components that do not contact urine. For example, the disposable kit may include the peristaltic pump tubing along with the clamp 26 (FIG. 1A) and / or the tube anchor 34 (FIG. 1B). Alternatively or additionally, parts of the peristaltic pump itself, such as the rotor and / or rollers, may belong to the disposable kit. Alternatively or additionally, for any type of pump, the actuator of the pump may belong to the disposable kit.

[0194] It should be noted that each of the above described features may be implemented in any one of the embodiments described below with reference to the figures.

[0195] In the context of this application, including the claims, a "reversible bond" of two items to one another means any bond that can be undone without the use of any tools (and without destroying any of the items).

[0196] Some advantages of embodiments of the present invention include:

[0197] 1. Given that the urine is pumped, the flow of urine from the bladder is not dependent on gravity. Therefore, the control unit and urine collection bag can be placed at any height. (In contrast, a gravity-based system may require the collection bag to be placed on the floor where it may become contaminated.) For example, the control unit may be coupled to the railing of the subject's bed, which is typically at a convenient height, and the urine collection bag may be elevated off the floor.

[0198] 2. Given the lack of reliance on gravity as discussed above, the conduit may be of any length. (In contrast, a gravity-based system may require limiting the length of the tube draining the bladder.) Thus, for example, the control unit may be located at the back or foot of the subject's bed, and the conduit may be threaded from the urinary catheter to the control unit. In this regard, it is noted that there are several advantages to locating the control unit at the back or foot of the bed. For example, the control unit is less likely to collide with objects (e.g., a doorpost) when the subject's bed is moved. Furthermore, due to the long length of the conduit, the subject may be treated or turned over without the conduit becoming entangled.

[0199] 3. The bladder can be constantly emptied by a pump so that the amount of urine drained from the bladder serves as an accurate surrogate for real-time urine production by the kidneys. In contrast, in gravity-based systems, the bladder may hold a significant amount of urine, averaging ~100 ml of urine, and this amount may vary over time. Thus, in gravity-based systems, urine drainage from the bladder may not serve as an accurate surrogate for real-time urine production by the kidneys. Furthermore, residual urine increases the risk of catheter-associated urinary tract infections.

[0200] 4. The urinary pumping systems described herein may be configured to overcome certain factors that may inhibit the release of urine from the bladder, including obstruction of the duct and / or suction of the bladder into the eyelet of the urinary catheter.

[0201] System Description Reference is first made to Fig. 66A, which is a schematic illustration of a disposable kit 370 for facilitating measurement of urine output and / or urine production, according to some embodiments of the present invention, and Fig. 66B, which is a schematic illustration of a system 96 (herein referred to as a "urinary pumping system") for measuring urine output and / or urine production, according to some embodiments of the present invention.

[0202] The system 96 includes a kit 370 with a non-disposable urine pumping device 129. The kit 370 includes a fluid conduit 371 configured for urine flow therethrough. The conduit 371 includes at least one tube configured to carry urine flowing downstream from a subject's bladder through a urinary catheter (e.g., a Foley catheter) that catheterizes the subject. The conduit 371 further includes a conduit section 31 coupled to the tube in fluid communication with the tube. In some embodiments, the kit 370 further includes a cartridge 374 (which may also be referred to as a "cassette") or another type of housing that includes the conduit section 31.

[0203] The device 129 includes one or more force applying elements configured to reversibly couple to the conduit 371 (particularly to the conduit section 31) and to apply a force to the conduit (particularly to the conduit section 31) when coupled to the conduit. When a force is applied, urine is forced out of the conduit section in a downstream direction, i.e., away from the subject's bladder.

[0204] In some embodiments, the force-applying element of the urinary pumping apparatus includes a pushing element, i.e., an element configured to apply a force to the conduit section 31 by pushing against the conduit section, and an actuator configured to actuate the pushing element. For example, the conduit section 31 may have a peristaltic pump tube 33 and the urinary pumping apparatus may have a peristaltic pump 20 including a rotor or one or more linear translation elements configured to push against the peristaltic pump tube 33. Alternatively, the conduit section 31 may have a pump chamber having a movable wall (e.g., a diaphragm wall or a piston wall) and the urinary pumping apparatus may have a plunger configured to push against the movable wall, e.g., as described below with reference to Figures 63A-B and 64A-B.

[0205] In other embodiments, the force applying element comprises an actuator configured to apply pneumatic or hydraulic force to the conduit section via a fluid filled tube. In such embodiments, the conduit section may have a pump chamber having a movable wall and the force may be applied to the movable wall. For example, as described below with reference to Figures 50-51 and 52A-B, the conduit section may have a diaphragm or piston wall to which the force is applied via a fluid in the tube.

[0206] In some embodiments, as shown in Figure 66A, the conduit 371 has both an upstream tube 28 connected to the upstream end of the conduit section 31, and thus carrying urine to the conduit section, and a downstream tube 29 (hereinafter also referred to as the "outlet tube") connected to the downstream end of the conduit section, and thus carrying urine from the conduit section. (Thus, the conduit 371 may have at least three tubes in fluid communication with each other: the upstream tube 28, the peristaltic pump tube 33, and the outlet tube 29.) The downstream end of the outlet tube 29 is connected to a urine collection bag 78 (e.g., as shown in Figure 65), which may also belong to the kit 370.

[0207] In other embodiments (eg, as shown in FIGS. 50-51 and 65), the conduit 371 does not have an upstream tube 28.

[0208] The device 129 further includes a controller 125 (which may also be referred to as a "processor") configured to control the pumping of urine through the conduit and to perform other functions described herein.

[0209] In some embodiments, the conduit 371 further includes an expandable portion configured to expand as urine flows through the expandable portion. A sensor 50, which may reside in the kit 370 or the urine pumping device, is configured to sense the degree of expansion of the expandable portion and generate a signal indicative of the degree of expansion. The signal is communicated to the controller 125, which pumps urine through the conduit in response to the signal, and optionally in response to other parameters, as described in more detail below in the section entitled "Pump Control."

[0210] For example, the conduit 371 may have an expandable reservoir 40 disposed upstream of the conduit section 31. For example, the reservoir 40 may be coupled to the upstream end of the tube 28 such that urine flows from the reservoir into the tube 28. In such an embodiment, the sensor 50 may be configured to communicate a signal to the controller that varies depending on the amount of urine in the reservoir. Optionally, the reservoir and the sensor may be contained in a housing 74.

[0211] Alternatively, the conduit section 31 itself may be expandable, and the conduit section may include a movable wall that expands outwardly as urine flows into the conduit section. For example, the movable wall may expand outwardly from its default (or "relaxed") position as urine flows into the conduit section, and then collapse back to its default position as urine is pumped out. Alternatively, the movable wall may collapse inwardly from its default position as urine is pumped out, and then expand back to its default position as urine flows in. In such an embodiment, the sensor may be configured to communicate a signal to the controller that varies depending on the amount of urine in the conduit section.

[0212] In other embodiments, the conduit 371 includes a non-expandable reservoir and the sensor 50 senses the amount of urine in the reservoir.

[0213] In some embodiments, as described below with reference to FIG. 30, the kit 370 includes a pressure sensor configured to sense pressure at the outlet of the urinary catheter and transmit a signal indicative of the pressure to the controller. Alternatively, the pressure sensor may be connected to the catheter connector or other portion of the conduit 371 near the catheter or downstream thereof. In such an embodiment, the kit 370 may include a reservoir 40 and a sensor 50, although the kit need not necessarily include these components, given that the controller may control the pumping of urine in response to a signal from the pressure sensor. (In practice, the bladder acts as a reservoir, and the pressure at the outlet of the bladder catheter increases in response to the amount of urine in the bladder.)

[0214] Alternatively, in embodiments in which the amount of urine in the conduit section increases as urine is produced (e.g., in embodiments in which the conduit section has a chamber with a movable wall that expands outward as urine flows into the chamber), the kit 370 may include a sensor (e.g., a pressure sensor) configured to transmit a signal that varies with the amount of urine in the conduit section. Even in such embodiments, the conduit 371 does not necessarily have to include a reservoir 40 or a sensor 50. (In practice, the conduit section functions as a reservoir.) Such an embodiment is described below, for example, with reference to FIG. 67.

[0215] Alternatively, the (non-disposable) urine pumping device, rather than the kit 370, may include a pressure sensor. In such an embodiment, the kit 370 may further include a connection port coupled to the tube 28 or conduit section 31 and configured to couple to a tube containing fluid such that the pressure of the fluid changes in response to the pressure in the tube or conduit section. (Optionally, the kit 370 may further include a fluid-filled tube.) Thus, a pressure sensor residing in the urine pumping device may sense the fluid pressure, and the controller may control the pumping of urine in response to the fluid pressure. Such an embodiment is described below, for example with reference to Figures 58, 61 and 67.

[0216] In some embodiments, the kit 370 further comprises a catheter connector 72 configured to couple at its upstream end to a urinary catheter (optionally via another connector as shown in FIG. 30) so as to establish fluid communication between the urinary lumen of the catheter and the lumen of the connector 72. The downstream end of the catheter connector 72 may couple to the reservoir 40 such that the lumen of the catheter connector is in fluid communication with the reservoir. Alternatively, in embodiments in which the reservoir is omitted or is integral with the catheter connector (e.g., according to FIG. 14), the downstream end of the catheter connector 72 may couple to the tube 28 (as in FIG. 28) or the conduit section 31 (as in FIGS. 50-51 and 65).

[0217] In some embodiments, the catheter connector 72 is formed to define a sampling port 372 through which a urine sample can be extracted from the lumen of the catheter connector. Alternatively, the sampling port 372 may be located in the tube 28 or at any other suitable location along the conduit.

[0218] In other embodiments, the catheter connector 72 is omitted and the urinary catheter is directly coupled to the reservoir 40, tube 28 or conduit section 31.

[0219] In some embodiments, the conduit 371 further includes a urinary catheter and may optionally have a temperature sensor configured to sense the temperature of the urine.

[0220] As discussed above, the controller 125 is configured to control the force application element such that the force application element applies pressure to the conduit, thereby squeezing urine downstream from the conduit. The controller is further configured to calculate the volume of squeezed urine based on the control of the force application element. For example, the rotary peristaltic pump 20 may be configured to pump a known volume of urine for any given revolution or fractional revolution such that the controller can calculate the volume of urine pumped based on the number of revolutions or fractional revolutions performed by the pump and the respective volume pumped during the revolutions or fractional revolutions. More details on such calculations are provided in the "Calculating Volume Pumped" section below.

[0221] In general, in embodiments in which the force applying element resides in a urine pumping device, the conduit 371 (particularly the conduit section 31) and the force applying element may be reversibly coupled to each other via any suitable mechanism.

[0222] For example, the urine pumping device 129 may have a case coupled to a force imparting element, which may be reversibly coupled to the conduit by the case reversibly coupling to the conduit. One example of a case that may be reversibly coupled to a conduit is the control unit 130 that includes the controller 125.

[0223] For example, the conduit (or at least the conduit section 31) may be at least partially contained in a cartridge 374 and the case may be formed to define a slot 376, and the case may be reversibly coupled to the conduit via insertion of the cartridge into the slot. For example, in an embodiment in which the pump 20 has a rotor and the conduit section 31 has a peristaltic pump tube 33, the cartridge 374 may be inserted into the slot 376 such that the rotor contacts the peristaltic pump tube. To separate the conduit from the case (e.g., when transferring the urinary pumping device 129 to another subject), the cartridge may simply be slid out of the slot, optionally after execution of a release mechanism.

[0224] As another example, as further described below with reference to Figures 63A-B and 64A-B, the conduit may be coupled to one or more latches and the case may reversibly couple to the conduit by the latches latching to the case. Alternatively, the case may have one or more latches configured to latch to a housing of the conduit, thereby reversibly coupling the case to the conduit.

[0225] In some embodiments, the control unit has a start / stop button 298. Alternatively or additionally, the control unit may have an insert / remove button 300 that is pressed when coupling the conduit to the case and before uncoupling the conduit from the case. (Pressing the button 300 before uncoupling the cartridge may implement the release mechanism described above.)

[0226] In some embodiments, the control unit 130 may further include a display (or "monitor") 378, typically having a touch screen. In such embodiments, the controller 125 is configured to display relevant output and / or receive relevant input via the display 378. Alternatively or additionally, the controller may be configured to display relevant output and / or receive relevant input via another peripheral device (such as a patient monitor, display, keyboard, mouse, etc.) or another computer connected wired or wirelessly to the control unit.

[0227] In some embodiments, the control unit 130 has a coupling mechanism 380, e.g., having one or more clamps or hooks. Using the coupling mechanism 380, the control unit can be coupled to the railings of the subject's bed or any other suitable structure.

[0228] As described in detail below, many variations of the system 96 are within the scope of the present invention. For example, the pressure sensor, reservoir, and / or pressure regulator may be connected to or integrated with the catheter connector 72, the housing 74, or the catheter itself. (The reservoir may have or function as a pressure relief valve.) Alternatively or additionally, the kit 370 may have a bag connector at the downstream end of the tube 29 configured to connect to a urine collection bag. Alternatively or additionally, the kit may have a urine collection bag. Optionally, the bag may have a drain valve for draining urine therefrom. Alternatively or additionally, the bag may have a one-way valve at the bag inlet. Alternatively or additionally, the kit may have a data storage medium (e.g., a QR code and / or memory) for storing data including, for example, a subject ID number, a serial number, a manufacturing lot number, an expiration date, kit calibration parameters, a security code, a kit type, or measurement parameters associated with the subject. Alternatively or additionally, the kit may have a suction relief tube for increasing the upstream pressure. Alternatively or additionally, the cartridge 374 may include additional components that interface with the pump 20, such as a clamp, as described below.

[0229] In general, the controller 125, in addition to each of the other processors described herein, may be embodied as a single processor or as a set of cooperatively networked or clustered processors. The functionality of the controller 125, and / or the functionality of any of the other processors described herein, may be implemented solely in hardware, e.g., using one or more fixed function or general purpose integrated circuits, application specific integrated circuits (ASICs), and / or field programmable gate arrays (FPGAs). Alternatively, the functionality may be implemented at least in part in software. For example, the controller 125 and / or any of the other processors described herein may be embodied as a programmed processor, including, e.g., a central processing unit (CPU) and / or a graphics processing unit (GPU). Program code and / or data, including software programs, may be loaded for execution and processing by the CPU and / or GPU. The program code and / or data may be downloaded in electronic form to the controller or processor, e.g., over a network. Alternatively or additionally, the program code and / or data may be provided and / or stored in a non-transitory tangible medium, such as a magnetic, optical, or electronic memory. Such program code and / or data, when provided to a controller or processor, produces a machine or special purpose computer configured to perform the tasks described herein.

[0230] Reference is now made to FIG. 65, which is a schematic diagram of a system 96, according to some embodiments of the present invention.

[0231] In some embodiments, the system 96 includes a case 336 coupled to at least some of the force-applying elements (e.g., pump rotors) and separate from the control unit 130. Typically, the case 336 couples to the conduit section 31 upstream from the control unit.

[0232] In such embodiments, the case 336 may be reversibly or irreversibly connected to the control unit 130 (and thus to the controller contained therein) by any suitable connection medium. For example, in embodiments in which a pump actuator is coupled to the case 336, the controller may be connected to the actuator via electrical wiring 366 and may control the actuator by controlling the voltage, current, duty cycle and / or frequency of the electrical power provided via the wiring 366. Alternatively, the controller may be connected to the actuator via optical fiber and may control the actuator by controlling the intensity and / or wavelength of the light provided via the fiber. Alternatively, the controller may be connected to the actuator via a wire or string within a tube and may control the actuator by controlling the mechanical force (linear or radial) provided to the wire or string. Similarly, in embodiments in which the actuator is within the control unit 130, the actuator may actuate an upstream pump component via a wire or string within a tube.

[0233] Alternatively or additionally, in embodiments including pneumatic or hydraulic sensing and / or pump actuation, the control unit may be connected to the case via one or more tubes 368. To control pneumatic or hydraulic actuation, the controller may control the pressure in the appropriate tubes 368, for example, by controlling an air compressor and / or one or more valves. For pneumatic or hydraulic sensing, the control unit may have a pressure sensor configured to sense the pressure in the appropriate tubes 368.

[0234] Similarly, in embodiments where the sensor is coupled to the case 336, the signal from the sensor may be communicated to the control unit via electrical wiring 366, tubing 368, or any other connection medium. The sensor may include, for example, an optical sensor configured to detect deflection of the reservoir wall or diaphragm 430 (FIG. 67) toward or away from the optical sensor.

[0235] In general, the aforementioned connection medium may be permanently connected to the control unit 130 or may be reversibly connected via a matching connector.

[0236] Reference is now made to FIG. 31, which illustrates a block diagram of some components of system 96, according to some embodiments of the present invention.

[0237] In some embodiments, as described further below with reference to FIG. 1A, peristaltic pump 20 has a rotor 22 that includes one or more rollers 24. In some embodiments, rotations of rotor 22 are quantized into fractional rotations, referred to herein as "strokes." Typically, the number of strokes in a 360 degree rotation is equal to the number of rollers 24; for example, with four rollers, each rotation includes four strokes. (More generally, for any type of pump, the term "stroke" is used herein to refer to a single pumping action performed by the pump.)

[0238] Typically, the controller 125 executes a control logic module 184, which controls the pump 20 in response to output from the sensor 50 monitoring the reservoir and / or one or more other sensors (e.g., a pressure sensor), as further described below in the section entitled "Sensors for Reservoir and Pump Control." As the pump operates, the control logic module 184 communicates data regarding the pump's activity (e.g., the time of each stroke and / or the time between successive strokes) to a calculation logic module 186, which is also executed by the controller. Based on these data, the calculation logic module 186 calculates the volume of urine pumped as a function of time, and thus the rate of urine excretion and / or production. In some embodiments, the calculation logic module also filters any noise that may affect the calculations, as further described below in the section entitled "Noise Filtering and Display." Such noise may be due to mechanical or biological factors.

[0239] In addition to the pump activity data described above, the computational logic module may calculate the volume of each stroke based on any other relevant data, such as the number of past strokes elapsed, the elapsed time (e.g., time elapsed since the previous stroke or start of operation), ambient temperature, urine temperature, pump inlet pressure, pump outlet pressure, calibration parameters, or pump speed.

[0240] Typically, the control unit 130 is wired or wirelessly connected to a patient monitor, a dedicated display (e.g., display 378 (FIG. 66B)), a computer network, a gateway, a nurse's station monitor, a cell phone, a tablet, an EMR, another computer, and / or another device (e.g., an intravenous pump). (Typically, any wired connections go through a cable, as described below with reference to FIG. 55.) The controller 125 may further execute a communications logic module 194 that communicates relevant outputs, such as calculated parameters related to urine production, to any of these entities. Optionally, the communications logic module 194 may receive relevant inputs, such as subject data (e.g., subject ID or weight) or alarm thresholds, from any of these entities.

[0241] Typically, the control unit 130 has a program memory (e.g., flash memory) 188 that may store the software code of the aforementioned modules. In some embodiments, the control unit further includes a non-volatile memory (NVM) 190 that may store data such as calibration parameters, measurement data, subject data, or alarm thresholds. Alternatively or additionally, the control unit may have a random access memory (RAM) 192 for executing the above-mentioned modules.

[0242] In some embodiments, the system 96 further comprises a power supply box 314 configured to provide power to components of the system such as the controller, the pump (particularly the pump actuator), and the sensors 50, as further described below with reference to Fig. 55. The system 96 may further comprise one or more batteries 196 configured to provide power to the aforementioned components when the control unit is disconnected from the power supply box or when the power supply box is disconnected from the mains. The batteries 196 are rechargeable and may be charged by the power supply box 314. Alternatively, the system may have the battery 196 without the power supply box 314.

[0243] Reference is now made to FIG. 55, which is a schematic diagram of a control unit 130 connected to a power box 314, according to some embodiments of the present invention.

[0244] In some embodiments, the control unit 130 is connected to a single cable 312 that is used for both power and communications. In such embodiments, even though the control unit is coupled to the subject's bed, it is relatively easy to move the bed given that only a single cable needs to be unplugged.

[0245] In such an embodiment, the control unit 130 has an electrical interface 311 connected to the controller 125 and configured to couple to the cable 312 such that the controller is powered via the cable 312. (One or more other components of the urine pumping device 129, such as a pump actuator and / or a sensor, may also be powered via the cable.) The control unit further has a communications interface 313, such as an Ethernet networking interface, connected to the controller and configured to couple to the cable. (Optionally, the electrical interface 311 and the communications interface 313 may be included in a single unit, such as a Universal Serial Bus (USB) Type C connector, as shown in FIG. 55.)

[0246] The controller is configured to exchange relevant communications via the communication interface and cable. For example, via the communication interface and cable, the controller may output a calculated volume of pumped urine, a parameter derived from said volume (e.g., urine production rate or a representative rate of change of said urine production rate, as described below with reference to FIG. 56), or intra-abdominal pressure (IAP). Alternatively or additionally, via the communication interface and cable, the controller may receive inputs such as operational commands (e.g., start or stop commands), subject ID or weight, or alarm thresholds.

[0247] Typically, the urine pumping device 129 further comprises a power supply box 314 that facilitates the exchange of power and communications. Advantageously, given that the power supply box is stationary, the EMR may locate the subject based on communications from the power supply box.

[0248] The power box 314 has a mains power connector 316 for connecting to a hospital alternating current (AC) wall power source. The power box further has one or more communication ports 318, each of which may be connected to a patient monitor, a hospital network, an EMR, or other suitable device or system. The power box may further have one or more electronic components associated with the communication lines, such as a surge protector, an electromagnetic interference (EMI) filter, a radio frequency interference (RFI) filter, or an isolator. Alternatively or additionally, the power box may have circuitry for mediating communication between the controller and the device or system to which the communication port is connected.

[0249] In some embodiments, the power box further comprises a non-volatile memory configured to store information related to the subject, such as the subject's ID and / or physiological parameters. The advantage of storing these data in the power box is that if the control unit is replaced, the data can be restored from the power box.

[0250] In some embodiments, to further facilitate bed movement of the subject, the control unit includes a separation connector configured to mate with a separation connector at the end of cable 312. The separation connectors are configured to separate from one another when a force pulling the separation connectors apart from one another exceeds a force holding the two connectors together. For example, the separation connectors may be coupled to one another by magnets, springs, friction between the walls of the connectors, or a vacuum force.

[0251] In an alternative embodiment, instead of an external power supply box, the control unit has an integrated power supply and the components of the power supply box 314 described above are integrated into the control unit.

[0252] Various aspects of the system 96 are described in further detail herein.

[0253] pump

[0254] I. Pumps with pressing elements

[0255] (a) Peristaltic pump

[0256] Reference is now made to FIG. 1A, which is a schematic diagram of a peristaltic pump 20, according to some embodiments of the present invention.

[0257] As described above with reference to Figures 66A-B, in some embodiments the force applying element that applies force to the conduit, thereby pushing the urine downstream, comprises a pushing element and an actuator, which is controlled by the controller 125.

[0258] For example, a urine pumping device may include a peristaltic pump 20. In some embodiments, the peristaltic pump includes a rotor 22 having multiple (e.g., four) rollers 24. The rotor 22 is configured to rotate pushing against the peristaltic pump tube 33 (FIG. 66A) in response to torque applied by an actuator, thereby moving urine from the tube in a direction corresponding to the direction of rotation of the rotor. The actuator may include a direct current (DC) motor, a stepper motor, a brushless motor, an air or hydraulic motor, or an air or hydraulic piston.

[0259] Typically, pump 20 further includes a clamp 26 configured to clamp the peristaltic pump tubing to rotor 22 to facilitate this action. In some embodiments, clamp 26 is coupled to a spring that presses the clamp against the rotor, as described below with reference to Figures 36A-B and 39A-C. Alternatively or additionally, one or more springs may be coupled to the rotor, as described below with reference to Figures 41-46.

[0260] Typically, the rotor 22 is mounted on and rotates about an axis 32 that is coupled to a pump base 36. In some embodiments, the pump base 36 is formed to define a pair of sockets 30, the function of which is described immediately below. The pump base 36 may be housed, for example, within a control unit 130 (FIG. 66B).

[0261] Reference is now further made to FIG. 1B, which is a schematic illustration of a peristaltic pump tube 33 according to some embodiments of the present invention, and FIG. 1C, which is a schematic illustration of a pump 20 mechanically coupled to the peristaltic pump tube according to some embodiments of the present invention.

[0262] In some embodiments, a pair of tube anchors 34, which may be U-shaped, secure the peristaltic pump tubing to the base 36 both upstream and downstream of the clamp 26, for example, by being received in the socket 30 such that the tubing is held against the base by the tube anchors. Advantageously, the tube anchors restrain the portion of the tubing 33 between them from being stretched or compressed, thereby facilitating more accurate calculation of the amount of urine moved from the tubing by the pump 20. In such an embodiment, the cartridge 374 (FIG. 66A) may have tube anchors 34 such that the tube anchors fit into the sockets when the cartridge is inserted into the control unit (including the pump base).

[0263] In other embodiments, tube anchors 34 (permanently) secure tubes 33 to the cartridge and sockets 30 are omitted.

[0264] 1C shows clamp 26 pressing tube 33 against rotor 22, thereby mechanically coupling the tube to the rotor. A silhouette 38 of the clamp shows the initial position of the clamp prior to mechanical coupling.

[0265] As described below in the section entitled "Sensors for Reservoir and Pump Control," peristaltic pump 20 can be controlled in response to various types of sensor signals.

[0266] (b) Reciprocating pump

[0267] Reference is made to Figures 63A-B, which are schematic diagrams of a reciprocating pump 20a and conduit section 31 according to some embodiments of the present invention.

[0268] In some embodiments, the urine pumping device 129 (FIG. 66B) includes a reciprocating pump 20a having a plunger 350 (or other type of pushing element) and an actuator 352. In response to a control signal from a controller, the actuator advances and retracts the plunger 350 such that the plunger repeatedly pushes against the conduit section, thereby displacing urine from the conduit section. Typically, the plunger and actuator are coupled to a case 348, which may be coupled to the control unit 130 (FIG. 66B), for example, within the control unit. (As discussed above with reference to FIG. 66B, the control unit itself may also be referred to as the "case.")

[0269] In such an embodiment, the conduit section 31 typically includes a chamber housing 342 that encloses the pump chamber 276. A front wall of the chamber housing 342 facing the pump 20a is formed to define an opening that is filled by a movable wall 343. The conduit section 31 and the pump 20a are configured to mate with one another such that the plunger pushes against the movable wall 343 as the plunger advances.

[0270] The conduit section 31 further includes an inlet port 338 that is separated from the pump chamber 276 by an inlet valve 274. The inlet port 338 is configured to couple to a urinary catheter (optionally via the catheter connector 72 and / or tubing 28 ( FIG. 66A )) such that as urine is produced by the subject's kidneys, urine flows into the pump chamber via the inlet port 338 and the inlet valve 274.

[0271] The conduit section 31 further has an outlet port 340 separated from the pump chamber 276 by an outlet valve 284. The outlet valve 284 may be held closed by a bias spring 286. When the plunger presses on the movable wall 343, the movable wall moves inward such that the volume of the pump chamber decreases and urine is forced through the outlet valve 284 and into the outlet port 340. The outlet port 340 is coupled to the outlet tube 29 (FIG. 66A) or directly to a urine collection bag.

[0272] The conduit section 31 and the pump 20a may be coupled to one another using any suitable mechanism. For example, the conduit section may be housed in a cartridge 374 that may be inserted into the control unit 130 as described above with reference to FIG. 66B. Alternatively, for example, the housing 342 may be coupled to one or more latches 346 that latch to the case 348. For example, the side walls of the case 348 may have respective front projections 354 that project inwardly toward the center of the front opening of the case 348 that faces the conduit section 31. The latches 346 may be inserted through the front opening and between the front projections 354 such that upon passing the front projections, the latches snap outwardly (i.e., sideways) and latch to the front projections, as shown in FIG. 63B. Alternatively, the front projections 354 may face outward and the latches snap inward and latch to the front projections.

[0273] In some embodiments, the movable wall 343 has a diaphragm 344. During each pump stroke, the actuator 352 advances the plunger 350 such that the plunger pushes the diaphragm 344 from its relaxed position 356 into the chamber 276, thereby forcing urine through the outlet valve 284 and the outlet port 340. In some embodiments, the advancement of the plunger is performed at the beginning of the stroke. Following the advancement, the plunger is retracted such that the diaphragm returns to the relaxed position 356 and urine is drawn from the inlet port 338 through the inlet valve 274 and into the chamber. In other embodiments, during each pump stroke, the actuator first retracts the plunger, thereby drawing urine into the chamber, and then advances the plunger, thereby forcing urine out of the chamber.

[0274] The actuator 352 may include an electric actuator, a pneumatic actuator, or a hydraulic actuator. For example, the actuator may include an electric solenoid, a linear motor, a motor with a lead screw, a motor with a ball screw, a motor with a roller screw, or a motor with a moving nut. Alternatively, the actuator may include a DC motor, a stepper motor, a brushless motor, a pneumatic or hydraulic motor, or a pneumatic or hydraulic piston, any of which may be coupled to a camshaft for linear actuation. The actuator is connected to a controller by control lines (not shown).

[0275] Reference is now made to Figures 64A-B, which are schematic diagrams of a reciprocating pump 20a and conduit section 31 according to another embodiment of the present invention.

[0276] In some embodiments, the housing 342 has a cylinder 360 that opens into the chamber (and thus is in fluid communication with the chamber 276). The movable wall 343 has a piston 358 disposed within the cylinder 360. During each pump stroke, the actuator 352 advances the plunger 350 such that the plunger pushes against the piston 358, thereby forcing urine through the outlet valve 284. The plunger may be advanced at the beginning or end of each stroke, as described above with respect to Figures 63A-B.

[0277] In some embodiments, the piston 358 is formed to define a socket 362 that is configured to matingly receive the plunger head 364 of the plunger 350. Thus, when the plunger is retracted, the plunger pulls the piston with it.

[0278] As described below in the section entitled "Sensors for Reservoir and Pump Control," the reciprocating pump 20a may be controlled in response to various types of sensor signals.

[0279] II. A pump with a fluid-filled tube for applying force

[0280] In some embodiments, instead of pressing against the conduit with a pressing element, a pumping force is applied to the conduit via a fluid, i.e., gas or liquid, contained within the tube. As the pressure of the fluid increases, it moves the movable wall of the conduit.

[0281] In this regard, reference is made to FIG. 50, which is a schematic illustration of a system 96 according to some embodiments of the present invention.

[0282] The embodiment of Figure 50 is similar to that of Figures 64A-B in that movement of a piston 358 causes urine to flow through a pump chamber 276. However, in Figure 50, the piston 358 is moved by pneumatic or hydraulic pressure. In particular, a cylinder 360 terminates in a connection port 282 configured (or permanently coupled) to couple to a fluid-filled tube. When an actuator 352, typically located in the control unit 130, changes the pressure of the fluid, the piston 358 advances or retracts against the opposing wall of the pump chamber.

[0283] In some embodiments, the conduit section 31 is coupled to three separate tubes. In particular, the outlet port 340 is coupled to the outlet tube 29 (FIG. 66A), the connection port 282 is coupled to a fluid-filled tube 291 (FIG. 58), and another connection port 86 is coupled to a (fluid-filled) pressure transmission tube 406 (FIG. 58), which is used for sensing as further explained below in the section entitled "Sensors for Reservoir and Pump Control". In such an embodiment, the fluid-filled tubes 291 and 406 may belong to a (non-disposable) urine pumping device. Alternatively, the fluid-filled tubes 291 and 406 may be permanently coupled to the conduit section and therefore belong to a disposable kit.

[0284] In other embodiments, connection port 282 and connection port 86 are coupled to different respective fluid-filled lumens of a single tube such that conduit section 31 is coupled to a total of two tubes, and in such embodiments, the fluid-filled tube may belong to the urine pumping device or disposable kit.

[0285] In yet another embodiment, the outlet port 340 and the two connection ports are coupled to different respective lumens of a multi-lumen tube 294 belonging to a disposable kit. In particular, the connection port 86 is coupled to a pressure measurement lumen 288, the connection port 282 is coupled to a pressure application lumen 290, and the outlet port 340 is coupled to a urinary lumen 292, which leads to a urine collection bag 78.

[0286] The actuator 352 may be reversibly coupled to the conduit section 31 by reversibly coupling the multi-lumen tube 294, or a separate fluid-filled tube, to the connection port 282 and / or the actuator. Any suitable tube connector known in the art may be used for this coupling.

[0287] In some embodiments, the upstream end 262 of the inlet port 338 is coupled to the catheter connector 72 or directly to the urinary catheter 124. In other embodiments, the upstream end 262 is coupled to a tube that carries urine from the urinary catheter.

[0288] Reference is now made to FIG. 52A, which is a schematic illustration of conduit section 31 according to some embodiments of the present invention.

[0289] In Figure 52A, the conduit section 31 is as shown in Figure 50 except that the conduit section 31 includes a diaphragm 344 instead of a piston 358. The edge of the diaphragm 344 is fixed to the wall of a cylinder 360. As the pressure in the cylinder 360 changes, the diaphragm expands towards or away from the opposing wall of the pump chamber.

[0290] Reference is now made to Figures 53 and 59, which are schematic diagrams of a control unit 130 according to different respective embodiments of the present invention.

[0291] In some embodiments, the actuator 352 comprises an actuation component 302, a screw 304 coupled to the actuation component 302, and a piston 306 coupled to an end of the screw 304. The piston 306 is disposed within a chamber 308, the compartment 310 of which is in fluid communication with the pressure application lumen 290 (or a separate fluid-filled tube). In some embodiments, the actuation component 302 comprises a motor, such as a DC motor, a brushless motor, or a stepper motor.

[0292] To increase the pressure in the pressure application lumen 290 (and thus in the cylinder 360 (FIG. 50)), the controller 125 drives the actuation component 302 to rotate the screw such that the piston 306 advances into the compartment 310, thereby compressing the fluid in the pressure application lumen 290. Conversely, to decrease the pressure in the pressure application lumen, the controller drives the actuation component to rotate the screw in the opposite direction. In some embodiments, the controller controls the actuation component in response to a signal from a pressure sensor that senses the pressure in the compartment 310.

[0293] In other embodiments, the screw 304 is omitted and the actuation component 302 includes a linear actuation solenoid coupled directly to the piston 306 .

[0294] As further described below in the section entitled "Sensors for Reservoir and Pump Control," pressure sensor 88 can be coupled to pressure measurement lumen 288 (or a lumen of another fluid-filled tube) and configured to transmit a signal indicative of the pressure within the lumen to the controller.

[0295] In some embodiments, the multi-lumen tube is inserted into the control unit 130 (or a separate fluid-filled tube is inserted) such that the pressure measurement lumen 288 is in fluid communication with the pressure sensor 88 and the pressure application lumen 290 is in fluid communication with the chamber 308, as shown in FIG. 53. In other embodiments, the control unit is connected to the tube(s) via a connector 382, ​​as shown in FIG. 59. (FIG. 59 also shows an output signal 384 from the controller, which may indicate, for example, the amount or rate of urine produced.)

[0296] Reference is now made to FIG. 57, which is a schematic diagram of a control unit 130 according to another embodiment of the present invention.

[0297] In some embodiments, the actuator 352 has a pump 386 configured to pump gas (e.g., air) into the chamber 308 through an inlet valve 388. An outlet valve 390 regulates the flow of gas from the chamber 308 to the pressure application lumen 290 (FIG. 50) or a separate gas-filled tube, and a third valve (not shown) regulates the release of gas from the pressure application lumen. The gas is released to the surrounding environment or another chamber similar to the chamber 308 and maintained at subatmospheric pressure by another pump similar to the pump 386.

[0298] To increase pressure in the pressure application lumen, the controller 125 opens the outlet valve 390. Conversely, to decrease pressure in the pressure application lumen, the controller opens the third valve so that gas is released from the pressure application lumen.

[0299] The controller 125 also controls the pump 386 to keep the chamber 308 filled with a sufficient amount of gas to raise the pressure in the pressure application lumen to the desired target value each time the outlet valve is opened. In some embodiments, the controller controls the pump in response to a signal from a pressure sensor that senses the pressure in the chamber 308.

[0300] Additionally, if gas is released into the other chamber as described above, the controller controls the other pump to keep the pressure in the other chamber low enough so that gas is drawn into the other chamber until a desired target value is reached each time the third valve is opened. In some embodiments, the controller controls the other pump in response to a signal from a pressure sensor that senses the pressure in the other chamber.

[0301] It is emphasized that the embodiments of Figures 53, 57, and 59 are presented here by way of example only, and that any suitable actuator may be used to apply pneumatic or hydraulic force to the conduit section. Such an actuator may have two outputs, one for moving the movable wall in one direction and the other for moving the movable wall in the opposite direction. To accommodate a second output, the multi-lumen tube 294 (Figure 51) may be formed to define an additional fluid-filled lumen.

[0302] Reference is now made to FIG. 58, which is a schematic diagram of a system 96 according to some embodiments of the present invention.

[0303] In some embodiments, the force application element of system 96 has a compound actuator having two components: an actuator 352 that varies the pressure in the fluid-filled tube 291 (e.g., as described above with reference to FIG. 57 or FIG. 59), and another actuator 396 that moves a shaft 398 in response to the pressure. Alternatively, a first actuator may apply a linear or radial force to a cable passing through the tube, and actuator 396 may move a shaft 398 in response to the force.

[0304] In such embodiments, the system 96 may include any suitable positive displacement pump 394. For example, the pump 394 may include a peristaltic pump 20 (FIG. 66B) and the shaft 398 may be coupled to a rotor or linear translation element of the pump. Alternatively, for example, the pump 394 may include a reciprocating pump 20a (FIGS. 63A-B and 64A-B) and the shaft 398 may be coupled to or include a plunger 350.

[0305] 58, fluid filled tube 291 and pressure transmission tube 406 (the function of which will be described in the next section below) may be coupled to connector 382 via respective connectors 400 (FIG. 57), such that fluid filled tube 291 is in fluid communication with the actuator and pressure transmission tube 406 is in fluid communication with pressure sensor 88. Similarly, in embodiments in which a cable carrying tube takes the place of pressure transmission tube 406, the cable carrying tube may be coupled via connector 400 such that an actuator in the control unit can apply a force to the cable.

[0306] Sensors for reservoir and pump control

[0307] Reference is now made to Figures 12A-B, which are schematic illustrations of a disposable kit 370 according to some embodiments of the present invention.

[0308] As described above with reference to FIG. 66A, the conduit 371 of the kit 370 may have a reservoir 40 upstream from the pump. The reservoir 40 may be housed in the housing 74 or catheter connector 72 along with the sensor 50. Typically, the reservoir 40 has an expandable tube 75 configured to expand as urine flows into the tube 75. For example, the expandable tube 75 may expand outwardly from its default (or "relaxed") state as urine flows into the expandable tube, and then collapse back to its default state as urine is pumped out. Alternatively, the expandable tube may collapse inwardly from its default state as urine is pumped out, and then expand again to its default state as urine flows in.

[0309] The sensor 50 is configured to monitor a parameter indicative of the amount of urine in the reservoir and to transmit a signal indicative of the value of the parameter to the controller. In some embodiments, a signal transmission element 76, such as a wire or optical fiber, carries the signal to the controller, e.g., as described below with reference to FIG. 67. (The signal transmission element 76 may extend along or within the lumen of the tube 28.) In other embodiments, the sensor 50 has a wireless transmitter configured to transmit the signal wirelessly.

[0310] 66A and 1B-C, the conduit 371 may further include a peristaltic pump tube 33 connected to a urine collection bag 78 via an outlet tube 29. (As described above with reference to FIG. 1C, the peristaltic pump tube 33 is configured to reversibly couple to the pump base 36, as shown by the dashed lines in FIGS. 12A-B.) Alternatively, the conduit 371 may include a pump chamber 276, and the outlet port 340 may be connected to a urine collection bag 78 via an outlet tube 29, as described above with reference to FIGS. 63A-B and 64A-B, for example.

[0311] (Similarly, just as the reservoir 40 and sensor 50 as shown in FIGS. 12A-B can be combined with any suitable type of conduit section and pump, it should be noted that the embodiments described below with reference to other figures, such as FIG. 13 and FIG. 67, can be combined with any suitable type of conduit section or pump, regardless of the particular conduit section or pump shown in those figures.)

[0312] In some embodiments, as shown in Figure 12A, the reservoir 40 is coupled at its upstream end to a catheter connector 72 (or directly to a urinary catheter) and at its downstream end to the tube 28 (e.g., via a housing 74 and / or an intervening tube). In other embodiments, as shown in Figure 12B, the reservoir 40 is in fluid communication with the tube 28 via a lateral opening 77 in the tube 28.

[0313] An exemplary embodiment of the sensor 50 for Figures 12A-B is described in the "Exemplary Reservoirs and Sensors" section.

[0314] Reference is now made to FIG. 13, which is a schematic illustration of a disposable kit 370 according to some embodiments of the present invention.

[0315] In some embodiments, a pressure transmission tube 82 formed to define a fluid-filled capillary lumen 84 (also referred to herein as a "pressure transmission tube") is coupled at its upstream end to the housing 74 such that the pressure transmission lumen 84 is in fluid communication with the volume 80 of the housing 74 between the inflatable tube 75 and the wall of the housing. (Alternatively, in embodiments in which the catheter connector 72 (FIGS. 12A-B) has a tube 75, the pressure transmission tube 82 may be coupled directly to the catheter connector.) The volume 80 and lumen 84 are filled with air or other gas.

[0316] In such an embodiment, the sensor 50 (which would typically belong to a urine pumping device rather than a disposable kit) includes a pressure sensor 88. The pressure transmission tube 82 is coupled at its downstream end to a connection port 86 that is configured to connect to the pressure sensor 88 such that the pressure sensor senses the internal pressure within the lumen 84 and volume 80. As the reservoir 40 expands (or "inflates") and contracts (or "deflates"), the internal pressure within the lumen 84 and volume 80 changes. The internal pressure is therefore indicative of the amount of urine in the reservoir.

[0317] In some embodiments, kit 370 has a multi-lumen tube formed to define a pressure transmission tube that functions similarly to the lumen of tube 82, and at least one other lumen that may carry urine or serve another function (similar to the lumen of tube 28).

[0318] Reference is now made to FIG. 14, which is a schematic illustration of a catheter connector 72 according to some embodiments of the present invention.

[0319] Figure 14 shows a variation of Figure 13 in which reservoir 40 is disposed within catheter connector 72. In such an embodiment, tube 28 may be coupled to a first port 90a of the catheter connector such that tube 28 is in fluid communication with the interior volume of reservoir 40, and tube 82 may be coupled to a second port 90b of the catheter connector such that capillary lumen 84 is in fluid communication with volume 80. Alternatively, different respective lumens of a multi-lumen tube may be coupled to the first port 90a and the second port 90b.

[0320] Reference is now made to FIG. 15, which is a schematic illustration of a dual lumen tube 92, according to some embodiments of the present invention.

[0321] In some embodiments, the conduit 371 includes a dual lumen tube 92 formed to define two lumens: a wider lumen 27 for carrying urine from the reservoir 40, and a capillary lumen 84 for pressure transmission.

[0322] In such an embodiment, reservoir 40 (e.g., with expandable tube 75) and volume 80 may be integrated into tube 92. In particular, reservoir wall 94, which is thinner (and therefore more flexible) than (i) the outer wall of tube 92 and (ii) the inner wall separating lumen 84 from lumen 27, may pass through the compartment of tube 92 (in effect, in such an embodiment) such that the pressure within compartment volume 80 and lumen 84 changes as wall 94 expands or contracts as a result of changes in pressure inside the reservoir.

[0323] Reference is now made to Fig. 20, which is a schematic illustration of a system 96 according to some embodiments of the present invention. Reference is further made to Fig. 21, which is a schematic illustration of a disposable kit 370 according to Fig. 20, according to some embodiments of the present invention. (In other words, Fig. 21 shows the disposable components of Fig. 20.)

[0324] In some embodiments, the disposable kit 370 is configured to couple to the urinary pumping device 129 such that both the reservoir 40 and the conduit section 31 are disposed within the control unit 130. For example, the reservoir may be disposed downstream of the tube 28, near the conduit section 31, such that the reservoir and the conduit section may both be coupled to the control unit. (For example, the reservoir portion and the conduit section may both be disposed within a cartridge 374, and the cartridge may be inserted into a slot 376 (FIG. 66B) in the control unit.) The upstream end of the tube 28 may be connected (e.g., via a catheter connector 72) to a urinary catheter 124 (e.g., a Foley catheter) that catheterizes the subject's bladder 122.

[0325] In some such embodiments, the control unit 130 has a sensor 50 located near where the reservoir is coupled to the control unit, e.g., near a slot in the control unit. In other such embodiments, the sensor belongs to the kit 370; for example, the sensor may be located near the reservoir, in a cartridge 374 (FIG. 66B). In either case, the controller 125 receives a signal from the sensor 50 and controls the pump 20 in response, as described above with reference to FIGS. 12A-B.

[0326] In embodiments in which the sensor resides in a kit, the signal transmission element 76 may terminate in a first electrical interface, as described below with reference to Figure 67. When the kit is coupled to the urine pumping device (e.g., when the cartridge is inserted into the slot), the first electrical interface may mate with a second electrical interface connected to the controller such that a signal from the sensor reaches the controller.

[0327] The controller 125 may further communicate the output, wired or wirelessly, to another computer processor 127, such as a processor residing in a patient monitor, display 378 (FIG. 66B) and / or an external display (e.g., a display in the doctor's room), an electronic medical record (EMR), and / or a doctor's cell phone or tablet. Optionally, all communications from the controller to other devices may be distributed via a gateway, server, or cloud.

[0328] In some embodiments, the system 96 further includes a drainage valve 126 for draining the urine collection bag 78 into a drainage tube 128 .

[0329] Reference is now made to Fig. 22, which is a schematic illustration of a system 96 according to some embodiments of the present invention. Reference is further made to Fig. 23, which is a schematic illustration of a disposable kit 370 according to Fig. 22 according to some embodiments of the present invention. (In other words, Fig. 23 shows the disposable components of Fig. 22.)

[0330] In contrast to Figure 20, in Figure 22 the reservoir 40 is upstream from the tube 28 (e.g., as in Figures 12A-B). Figure 22 also differs from Figure 20 in that the downstream end of the outlet tube 29 is coupled to a non-spill connector 134 configured to couple to a bag connector 136 connected to the bag 78 via a connecting tube 135. The bag connector 136 is described below in the section entitled "Bag Connector for Replaceable Fluid Bags."

[0331] (Notwithstanding the above, a connector may be used as in FIG. 22, or a drainage valve may be used as in FIG. 20.)

[0332] 23, the signal transmission element 76 may terminate in an electrical and / or optical connector 138 for connection to a controller. The connector 138 may include, for example, the electrical interface 428a (FIG. 67).

[0333] Reference is now made to FIG. 67, which is a schematic illustration of a reciprocating pump 20a with a conduit section 31, according to some embodiments of the present invention.

[0334] FIGURE 67 illustrates several techniques by which a (non-disposable) sensor residing in the urinary pumping device (e.g., by being coupled to case 348) may sense a parameter that varies with the amount of urine in an upstream portion of the conduit, such as a conduit section or reservoir, when the urinary pumping device is coupled to a conduit section. (Typically, only one of these techniques is implemented in a given embodiment.) As discussed above with reference to FIGURES 12A-B, although FIGURE 67 illustrates a reciprocating pump 20a, some of these techniques may be implemented in another type of pump, such as a peristaltic pump.

[0335] According to one such technique, pressure transmission lumen 84 transmits a fluid pressure that varies with the amount of urine in the upstream reservoir, as described above with reference to Figures 13-15. A pressure sensor 88 is connected to pressure transmission tube 406. When the urine pumping device is coupled to the conduit section, tube 406 couples to connection port 86 (e.g., by sliding the connection port), thereby effectively extending pressure transmission tube 84 such that the pressure sensor senses the fluid pressure within lumen 84.

[0336] Alternatively, the pressure sensor may sense fluid pressure via a pressure transmission tube coupled to the conduit section itself.

[0337] For example, pressure measurement tube 410 may be connected to inlet port 338 of chamber 276 (or a downstream portion of tube 28 in the case of a peristaltic or other positive displacement pump). Connection port 86 may be located at the end of pressure measurement tube 410, and diaphragm 430 may be located aft of connection port 86 at any point along the pressure measurement tube (e.g., at the end of the pressure measurement tube, between the pressure measurement tube and the inlet port). When the conduit section is coupled to the urine pumping device, pressure transmission tube 406 is coupled to connection port 86. Thus, changes in pressure in the conduit due to changes in the amount of urine in pump chamber 276, in the upstream reservoir, and / or in the bladder will cause diaphragm 430 to expand towards or away from the tube 406, thereby changing the fluid pressure in tube 406. These changes are sensed by pressure sensor 88.

[0338] Alternatively, the connection port 86 may be coupled to the front wall of the chamber housing 342 (i.e., the wall facing the pump 20a), for example adjacent the diaphragm 344, and the diaphragm 430 may be disposed behind the connection port. Following sliding of the tube 406 through the connection port 86, changes in the amount of urine in the pump chamber cause the diaphragm 430 to expand towards or away from the tube 406, thereby changing the fluid pressure in the tube 406. These changes are sensed by the pressure sensor 88.

[0339] Alternatively, reservoir 40 may be disposed at inlet port 338 (or at a downstream portion of tube 28 in the case of a peristaltic or other positive displacement pump) and sensor 50 may monitor the reservoir, for example, as described below in the section entitled "Exemplary Reservoirs and Sensors."

[0340] As yet another alternative, the actuator 352 may function as a sensor.

[0341] For example, the actuator may measure the force applied by the conduit to a pushing element (e.g., plunger 350), which varies with pressure in the conduit, and the controller may control the actuator in response to the force. For example, in an embodiment in which actuator 352 has a solenoid, the solenoid may sense changes in a magnetic field due to the changing force applied to plunger 350. Alternatively, a small amount of current, not enough to move the plunger, may be applied and the change in current may be measured.

[0342] As another example, the actuator may have an encoder configured to detect the position of a pushing element (e.g., plunger 350), which changes depending on the pressure and / or volume in the conduit, and the controller may control the actuator in response to the position.

[0343] Referring again to Figures 50 and 58.

[0344] 50 and 58, a pressure measurement tube 410 is connected to the inlet of the pump, and a diaphragm 430 is disposed between the pressure measurement tube and the inlet (FIG. 50) or within the pressure measurement tube (FIG. 58), as in one embodiment shown in FIG. 67. A fluid-filled lumen, such as pressure measurement lumen 288 (FIG. 50) or a lumen of pressure transmission tube 406 (FIG. 58), is coupled to connection port 86, and a pressure sensor (e.g., in control unit 130) is coupled to the fluid-filled lumen for sensing the pressure of the fluid as it varies with the internal pressure in the conduit.

[0345] As urine accumulates in the bladder, an increase in pressure at the pump inlet deflects the diaphragm 430 away from the inlet, resulting in an increase in pressure in the pressure measurement lumen 288 or pressure transmission tube 406. The controller detects this increase based on the output signal from the pressure sensor. In response to the pressure reaching a predetermined threshold, the controller may execute one or more pumping strokes.

[0346] Referring now in particular to FIG.

[0347] Each stroke begins with diaphragm 430 in an initial position and pressure measurement tube 410 and pressure measurement lumen 288 at an initial pressure.

[0348] In some embodiments, on each stroke, the controller first drives the actuator 352 to reduce pressure in the cylinder 360 so that the piston 358 is retracted (i.e., the pump chamber expands) and urine is drawn from the bladder into the pump chamber through the inlet valve 274. (In some cases, the bladder is emptied by drawing urine from it.) The controller then drives the actuator to increase pressure so that the piston moves forward. As pressure in the pump chamber increases, the inlet valve 274 closes, the outlet valve 284 opens, and urine flows out the outlet port 340, through the urinary lumen 292, and into the urine collection bag 78.

[0349] The pumping of urine reduces the pressure within the bladder. As a result of this pressure reduction, diaphragm 430 expands from its initial position toward the inlet port, thus increasing the volume within pressure measurement tube 410 and pressure measurement lumen 288. As a result of this volume increase, the pressure within pressure measurement tube 410 and pressure measurement lumen 288 decreases from its initial value.

[0350] Following pumping, the bladder begins to refill with urine produced by the kidneys, causing the pressure at the inlet port 338 to rise, causing the diaphragm 430 to return to its initial position and the pressure measurement tube 410 and pressure measurement lumen 288 to return to the initial pressure. In response to the return to the initial pressure, the controller initiates another set of one or more strokes.

[0351] In other embodiments, on each stroke, the controller first advances the piston, thereby forcing urine out of the pump chamber as described above, and then the controller retracts the piston by reducing the pressure in cylinder 360, thereby drawing more urine into the pump chamber.

[0352] In some embodiments, the number of strokes is predefined, while in other embodiments the controller executes a sequence of one or more strokes until the pressure in the pressure measuring tube 410 and pressure measuring lumen 288 reaches another predefined threshold.

[0353] In some embodiments, the diaphragm 430 is elastic. In such embodiments, following each stroke, the diaphragm advantageously exerts a suction force on the bladder such that urine is drawn from the bladder even when the pump is idle. In other embodiments, the diaphragm 430 is not elastic. However, even in such embodiments, the negative pressure in the pressure measurement tube 410 and pressure measurement lumen 288 advantageously exerts a suction force on the bladder such that urine is drawn from the bladder even when the pump is idle.

[0354] Reference is now made to Fig. 51, which is a schematic illustration of system 96 according to some embodiments of the present invention. Reference is further made to Fig. 52B, which is a schematic illustration of conduit section 31 according to some embodiments of the present invention. Reference is also made to Figs. 54, 60 and 62, which are schematic illustrations of control unit 130 according to the embodiments of Figs. 51 and 52B.

[0355] Figures 51 and 52B are similar to Figures 50 and 52A, respectively, in that the movable wall 343 (including piston 358 or diaphragm 344) is moved by pneumatic or hydraulic force. However, in Figures 51 and 52B, the conduit section 31 does not have a diaphragm 430 or a pressure measurement tube 410. Instead, the pressure sensor 88 is coupled to the same fluid-filled lumen as the pressure application lumen 290 of the tube 294 to which the pneumatic or hydraulic force is supplied. (Thus, the tube 294 may be formed to define only two lumens rather than a three lumen lumen.) The pressure sensor senses the pressure in the fluid-filled lumen (which varies with the internal pressure within the conduit) and communicates a signal indicative of the pressure to the controller. In response, the controller controls the actuator as described above with reference to Figure 50.

[0356] In particular, as urine accumulates in the bladder, an increase in pressure at the inlet port 338 causes the inlet valve 274 to open, resulting in an increase in pressure in the pump chamber 276. This increased pressure pushes the movable wall outward (i.e., expanding the pump chamber), thereby increasing the pressure in the cylinder 360, the connecting port 282 and the lumen 290. This pressure is sensed by the pressure sensor, and in response to the increased pressure, the controller executes one or more pump strokes as described above with reference to FIG. 50. After the final stroke, the cylinder 360 is fixed at the predetermined pressure by actuating the actuator in response to feedback from the sensor until the predetermined pressure is reached. Thereafter, as urine flows into the pump chamber, the pressure in the cylinder, and therefore in the lumen 290, rises from the predetermined pressure, and the magnitude of that rise (measured by the pressure sensor) is indicative of the amount of urine flowing in.

[0357] In some embodiments, the pressure in the pump chamber 276 is below atmospheric pressure both at the beginning (i.e., immediately before) and at the end (i.e., immediately after) of the stroke. Alternatively, the pressure may be above atmospheric pressure at the beginning of the stroke but below atmospheric pressure at the end of the stroke. Alternatively, the pressure may be above atmospheric pressure both at the beginning and at the end of the stroke.

[0358] (FIG. 54 is similar to FIG. 53, FIG. 60 is similar to FIG. 57, and FIG. 62 is similar to FIG. 59, except that pressure sensor 88 and actuator 352 are connected to a single fluid-filled lumen, e.g., via a single connector 382.)

[0359] Alternatively to the exemplary embodiment shown in Figures 50, 51 and 52A-B, system 96 may include any other suitable pneumatically or hydraulically actuated reciprocating pump that receives driving force from actuator 352 via pressure application lumen 290 and / or one or more other lumens.

[0360] Reference is now made to FIG. 61, which is a schematic diagram of a system 96 according to some embodiments of the present invention.

[0361] Figure 61 is similar to Figure 58 in that system 96 has a compound actuator. However, in Figure 61, pressure transmission tube 406 has been omitted and instead connection port 86 is coupled to fluid filled tube 291 via connection tube 402. Fluid filled tube 291 is coupled to both pressure sensor 88 and actuator 352, as shown in Figures 54, 60 or 62, for example. Thus, as the pressure in tube 291 changes due to the internal pressure in the conduit, these changes in pressure are sensed by the pressure sensor.

[0362] In other embodiments, instead of sensing fluid pressure via a fluid-filled lumen, a pressure sensor 88, which is typically disposable, is coupled to the conduit or urinary catheter to sense the internal pressure within the conduit or at the outlet of the urinary catheter. To facilitate this, the connection port 86 may be coupled to any portion of the conduit, such as the conduit or any of the tubing belonging to the conduit section 31, and coupled to the pressure sensor such that the pressure sensor senses the internal pressure of the portion of the conduit. In such an embodiment, the pressure sensor is configured to communicate a signal indicative of the pressure to the controller, and the controller is configured to control the pumping of urine in response to the signal.

[0363] In this regard, reference is made to FIG. 30, which is a schematic illustration of a system 96 according to some embodiments of the present invention.

[0364] In some embodiments, the pressure sensor 88 senses pressure at the outlet of the urinary catheter 124 (e.g., via a T-connector connecting the catheter outlet to a catheter connector, as shown in FIG. 30) and communicates a signal indicative of the pressure to the controller 125. The controller controls the pump (which may include a peristaltic pump 20 or any other type of positive displacement pump) in response to the signal. For example, when a pressure reaches a predetermined threshold due to accumulation of urine in the bladder, the controller may cause the pump to perform one or more strokes. (Effectively, in such an embodiment, the bladder itself serves as the upstream reservoir.)

[0365] In other embodiments, a pressure sensor 88 is coupled to the conduit to sense the pressure within the conduit and transmit a signal indicative of that pressure to the controller 125. For example, a pressure sensor may be coupled to the tube 28, e.g., downstream of the tube 28 within the control unit 130.

[0366] Alternatively to the exemplary embodiment shown in Figures 50-51, 53-54 and 57-62, the system 96 may include any other suitable pneumatic or hydraulic actuator that transmits driving force to the conduit section 31 or via one or more lumens to the actuator 396.

[0367] Referring again to FIG. 67, which also illustrates techniques by which the signal transmission element 76 (FIG. 12A) may be connected to a controller. In particular, in some embodiments, a first electrical interface 428a is connected to a conduit, e.g., conduit section 31, and is configured to connect (via signal transmission element 76) to a sensor, such as an upstream sensor 50 monitoring a reservoir or pressure sensor 88. Force application elements of the urine pumping device, such as plunger 350 and actuator 352, are connected (e.g., via case 348) to a second electrical interface 428b, which is connected to a controller. (Connections to the controller are not shown in FIG. 67.) The second electrical interface 428b is configured to contact the first electrical interface 428a when the conduit section 31 is connected to the force application element, such that the sensor communicates a signal to the controller via the first electrical interface and the second electrical interface. In other words, when the conduit section is connected to the urine pumping device, an electrical connection is established between the electrical interface 428a and the electrical interface 428b such that a sensor signal may be communicated to the controller.

[0368] Interface 428a and / or interface 428b are flexible and / or resilient. In some embodiments, one of the interfaces includes a spring-loaded ("pogo pin") connector and the other interface includes electrical contacts.

[0369] Exemplary Reservoirs and Sensors

[0370] 3A-C, which are schematic illustrations of a reservoir 40 in different states, according to some embodiments of the present invention. A first flow indicator 42a indicates urine flow into the reservoir, and a second flow indicator 42b indicates urine flow out of the reservoir.

[0371] 12A-B, in some embodiments, the reservoir 40 includes an expandable tube 75. In some embodiments, the expandability of the tube 75 results from at least a portion of the tube having greater elasticity relative to other tubes (e.g., tube 28) in the disposable kit. For example, at least a portion of the wall 44 of the tube 75 may be thinner than those of the other tubes.

[0372] Figure 3A shows the tube 75 in a rest state, which assumes that the internal pressure within the tube is equal to atmospheric pressure. Figure 3B shows the tube in an expanded (or "inflated") state, which assumes that the internal pressure within the tube is greater than atmospheric pressure, for example due to urine that has accumulated within the tube. Figure 3C shows the tube in a contracted state, which assumes that the internal pressure within the tube is less than atmospheric pressure.

[0373] Reference is now made to Figures 4A-C, which are schematic illustrations of reservoir 40 according to some embodiments of the present invention.

[0374] In some embodiments, wall 44 does not necessarily have a greater elasticity. Rather, wall 44 is formed to define opening 46 (FIG. 4A), and tube 75 further includes a flexible (elastic) diaphragm 48 (FIG. 4B). Diaphragm 48 is configured to couple to wall 44 through opening 46 (FIG. 4C), such that tube 75 is expandable due to the flexibility of the diaphragm.

[0375] In this regard, reference is made further to FIGS. 5A-C, which are schematic illustrations of reservoir 40 as shown in FIGS. 4A-C in different respective states, according to some embodiments of the present invention.

[0376] Figure 5A shows the reservoir with the diaphragm 48 expanding outwards because the internal pressure is greater than atmospheric pressure. Figure 5B shows the reservoir with the diaphragm in its relaxed state, which the diaphragm assumes when the internal pressure is equal to atmospheric pressure. Figure 5C shows the reservoir with the diaphragm collapsing inwards because the diaphragm is less than atmospheric pressure.

[0377] Reference is now made to Figures 6A-C, which are schematic illustrations of longitudinal cross sections through reservoir 40 in different respective states, according to some embodiments of the present invention.

[0378] In some embodiments, the wall 44 comprises a material 45 such as nylon that is not elastic, but rather is creased, and the tube 75 is expandable by the material 45 .

[0379] In particular, when reservoir 40 contains a small amount of urine, material 45 collapses inward, as shown in Figure 6A. On the other hand, when reservoir 40 contains a large amount of urine, material 45 expands outward, as shown in Figure 6C. When reservoir 40 contains an intermediate amount of urine, material 45 is maximally folded and does not expand inward or outward, as shown in Figure 6B.

[0380] (In the embodiments of FIGS. 3A-C and 4A-C, the reservoir 40 may exert positive and / or negative pressure on the bladder due to the elasticity of the tube wall or diaphragm 48, whereas in the embodiment of FIGS. 6A-C, the reservoir does not exert pressure on the bladder.)

[0381] In embodiments in which the conduit includes an expandable portion, such as an expandable reservoir or pump chamber, the system may have a sensor 50 configured to sense the degree of expansion of the expandable portion, i.e., the degree to which the expandable portion expands relative to its most compressed state. In particular, the sensor senses a parameter that correlates with (and is therefore indicative of) the degree of expansion, such as the position of a wall of the expandable portion.

[0382] In some embodiments, the sensor 50 includes an optical sensor configured to sense the degree of expansion of the inflatable portion by emitting light at the inflatable portion. In this regard, reference is made to Figures 7A-C, 8A-C, 9 and 10A-C. By way of example, each of these figures assumes that an optical sensor is operatively coupled to the reservoir 40 that includes the inflatable tube 75.

[0383] In some embodiments, as shown in Figures 7A-C, the sensor 50 includes a light source 52 configured to emit light 56 ​​at the reservoir 40 such that the light is reflected by the reservoir. (Optionally, as shown in Figures 8A-8C, the sensor 50 may further include at least one optical component 60, such as a lens through which the light 56 ​​is emitted.) The sensor 50 further includes a photodetector 54 configured to detect the reflected light 58 and generate a signal in response thereto.

[0384] The light source 52 and the photodetector 54 are positioned relative to one another such that the amount of reflected light 58 detected by the photodetector changes depending on the extent to which the reservoir expands or collapses. In one such arrangement, the light source 52 surrounds the photodetector 54.

[0385] Thus, when the reservoir is in its relaxed state, as in Figure 7A, a baseline amount of light is detected. When the reservoir is inflated, as in Figure 7B, more light is reflected away from the photodetector due to the convexity of the reservoir. Thus, the amount of light detected is less than the baseline amount. Conversely, when the reservoir is collapsed, as in Figure 7C, more light is reflected towards the photodetector due to the concavity of the reservoir. Thus, the amount of light detected is greater than the baseline amount. Thus, the amount of light detected varies with the amount of urine in the reservoir.

[0386] Similar to Figures 7A-C, Figures 8A-C show an embodiment in which sensor 50 emits light at the reservoir and generates a signal indicative of the amount of light detected. Figures 8A-C differ from Figures 7A-C in that light source 52 and photodetector 54 are positioned on opposite sides of the reservoir such that the photodetector detects light that is not reflected by the reservoir.

[0387] When the reservoir is relaxed, as in Figure 8B, the photodetector detects a baseline amount of light. When the reservoir is expanded, as in Figure 8C, the photodetector detects less than the baseline amount of light. Conversely, when the reservoir is collapsed, as in Figure 8A, the photodetector detects more than the baseline amount of light. Thus, the amount of light detected varies with the amount of urine in the reservoir.

[0388] In another embodiment, as shown in Figure 9, a sensor 50 has an optical fiber core 62 oriented perpendicular to the reservoir 40 such that light 56 ​​emitted through the core 62 by the light source 52 (Figures 8A-C) is partially reflected by the near wall 44a of the reservoir and partially reflected by the far wall 44b of the reservoir. The phase difference dp between the two reflections detected by the photodetector 54 (Figures 8A-C) indicates the extent to which the reservoir is expanding or collapsing and therefore the amount of urine in the reservoir.

[0389] 7A-C, Figures 10A-C show an embodiment in which the light source 52 and the photodetector 54 are located on the same side of the reservoir 40, such that the amount of reflected light detected by the photodetector varies with the amount of urine in the reservoir. However, in Figures 10A-C, the light source and the photodetector are spaced apart from each other and at an angle to the reservoir, such that the overlap 64 between the area illuminated by the light source 52 and the area from which light is reflected to the photodetector 54 varies with the extent to which the reservoir expands.

[0390] In particular, as shown in Figure 10A, overlap 64 is an increasing function of the distance d0 between the sensor 50 and the reservoir, which depends on the extent to which the reservoir expands. Thus, for example, overlap 64a when the reservoir is collapsed (Figure 10B) is greater than overlap 64b when the reservoir is in its rest state (Figure 10C).

[0391] In embodiments in which sensor 50 includes an optical sensor, the optical sensor may be further configured to sense a visual parameter of the urine (e.g., color, opacity, and / or transparency) and communicate a signal indicative of the visual parameter to the controller. Alternatively, a separate optical sensor may sense the visual parameter.

[0392] Reference is now made to Figures 11A-B, which are schematic illustrations of a contact sensor 50 operatively coupled to a reservoir 40 having an expandable tube 75, according to some embodiments of the present invention. (Alternatively, the contact sensor 50 may be operatively coupled to other expandable portions of the conduit.)

[0393] In some embodiments, the sensor 50 has a conductive element 66 coupled to the reservoir 40 and two electrical contacts 68. The conductive element 66 and the electrical contacts 68 function as a binary switch, the state of which indicates whether the reservoir is expanded. In particular, when the reservoir 40 expands, as shown in FIG. 11A, the switch is closed and electrical current can flow between the electrical contacts 68 via the conductive element 66. On the other hand, when the reservoir 40 does not expand, as shown in FIG. 11B, the switch is open. (In view of the above, this embodiment of the sensor 50 is also referred to below as a "switch.")

[0394] In other embodiments, the sensor 50 includes a pressure sensor configured to sense pressure within a fluid-filled volume external to the reservoir, for example according to any of Figures 13-15.

[0395] Alternatively, the sensor 50 may be of any other suitable type, such as ultrasonic, capacitive, inductive, resistive, or electromagnetic.

[0396] Optionally, for any of the embodiments of sensor 50 described above, one or more components of the sensor (eg, the entire sensor) may be disposable.

[0397] Pump Control

[0398] The controller continuously receives a signal that varies with the amount of urine in the subject's bladder or in a conduit connected to a urethral catheter that catheterizes the subject. As noted above, the signal may be received from an optical sensor, a pressure sensor, or any other suitable type of sensor. The signal may be indicative of the pressure in the conduit (or in a fluid-filled tube coupled to the conduit), the degree of expansion of an expandable portion of the conduit, or any other parameter that varies with the amount of urine.

[0399] As further described above, in response to the signal (and optionally in response to one or more other inputs), the controller controls a pump, which typically includes a positive displacement pump (e.g., a peristaltic or reciprocating pump), i.e., uses the pump to pump urine through the conduit. In some embodiments, the controller controls the pump such that pressure in the conduit remains less than atmospheric pressure.

[0400] For example, using a pump, the controller may keep the amount of urine in the bladder relatively constant, e.g., within 20 ml, e.g., within 10 ml. One advantage of keeping the amount of urine relatively constant is that the subject's urine production (i.e., the amount of urine made by the kidneys) can be tracked more closely in real time.

[0401] As a specific example, the controller may pump urine through the conduit such that the amount of urine in the bladder remains below 20 ml, such as below 10 ml. Keeping the bladder relatively empty facilitates measuring the subject's intra-abdominal pressure, as described in more detail in the "Measuring Intra-Abdominal Pressure (IAP)" section below.

[0402] It should be noted that the scope of the present invention includes the use of any pump, not necessarily a positive displacement pump, to keep the volume of urine in the bladder relatively constant. Thus, for example, a pump that is not a positive displacement pump can be used to keep the volume of urine in the bladder relatively constant, and the subject's urine output (which, due to the relatively constant volume in the bladder, may approximate the subject's urine production) can be measured manually, for example, by recording the fill level of a urine collection bag or another container, such as a graduated cylinder.

[0403] In this regard, reference is made to Fig. 16, which is a schematic illustration of the operation of a system 96 according to some embodiments of the present invention. By way of example, Fig. 16 illustrates an embodiment in which the disposable kit includes a reservoir 40 and a binary switch 50, and the urine pumping device includes a peristaltic pump 20. For simplicity and ease of illustration, some components of the system 96 have been omitted from Fig. 16, and instead the system 96 is shown as including an upstream module 98u including the reservoir 40 and the sensor 50, and a downstream module 98d including the pump 20 and the peristaltic pump tubing 33. Urine flows from the upstream module 98u through the tubing 28 to the downstream module 98d (Fig. 66A).

[0404] In stage A of operation, the reservoir 40 is filled with urine. Filling of the reservoir causes the signal from the switch 50, which was previously low (0), to jump to high (1), thus exceeding a predefined threshold (e.g., 0.5). In response to the signal exceeding the predefined threshold, the controller activates the pump.

[0405] For example, in the case of a rotary peristaltic pump, the controller may execute a pumping stroke by rotating rotor 22 (e.g., counterclockwise) such that roller 24a pushes a known amount of urine out of peristaltic pump tube 33 toward a urine collection bag further downstream. (In the illustrated example, pump 20 has four rollers such that the controller executes a quarter rotation of rotor 22.) As urine is pushed out of peristaltic pump tube 33, an equal amount of urine flows downstream from reservoir 40.

[0406] In stage B of operation, the pumping stroke has ended, so the reservoir 40 has collapsed due to urine being pumped out of the reservoir, and the switch 50 is open.

[0407] At stage C, the reservoir 40 begins to fill again due to the flow of urine into the reservoir. Eventually, the switch 50 is closed again and operation returns to stage A.

[0408] Reference is now made to FIG. 17, which illustrates a flow diagram 100 for the operation of the system 96 according to FIG. 16, according to some embodiments of the present invention.

[0409] In a first step 102, the controller activates the pump, i.e., initiates a pumping stroke. In a second step 104, the pump performs a stroke, thereby drawing a known amount of urine from the reservoir. The first step 102 and the second step 104 correspond to stages A and B of FIG.

[0410] In a third step 106, urine flows into the reservoir as described above with reference to stage C of Figure 16. Operation of the system then returns to the first step 102.

[0411] Reference is now made to Figure 18, which illustrates a flow diagram of a control algorithm 108 executed by the controller, according to some embodiments of the present invention. The algorithm 108 generalizes the control principles discussed above with reference to Figures 16-17.

[0412] In a signal sampling step 110, the controller samples the signal received from the sensor. Then, in an evaluation step 112, the controller evaluates whether the signal exceeds a predefined threshold. For example, in the case of a binary switch, as in FIG. 16, the controller may evaluate whether the signal is high or low. In the case of an optical sensor monitoring an expandable reservoir, the controller may evaluate whether the amount of light detected exceeds a threshold. In the case of a pressure sensor, the controller may evaluate whether the sensed pressure exceeds a threshold.

[0413] If not, the controller returns to signal sampling step 110 (optionally following a predefined waiting period). If not, the controller starts the pump in a pump start step 114 so that it begins pumping. Then, in a check step 115, the controller checks whether a predetermined condition for stopping the pump is met, for example as described below with reference to FIG. 19. If not, the controller repeats check step 115. If not, the controller stops the pump and records the elapsed time since the previous stroke in a record step 116. This elapsed time can be used to calculate the pumping volume and / or the subject's urine production rate. (The controller can also record other parameters used in these calculations, as described below in the section entitled "Calculating the Pumping Volume.") The controller then returns to sampling step 110.

[0414] In other embodiments, the controller simply causes the pump to perform a predefined number of strokes (e.g., a single stroke as shown in Figure 16). In such embodiments, in check step 115, the controller may check whether the predefined number of strokes has been performed.

[0415] For further details regarding the operation of system 96, see FIG. 19, which is an exemplary plot of a sensor signal 118 (e.g., indicating the amount of urine in the reservoir or the pressure at the outlet of the urinary catheter) as a function of time in accordance with some embodiments of the present invention.

[0416] A first portion 118a of the signal 118 corresponds to the gradual filling of the bladder or a portion of the conduit (e.g., a reservoir or pump chamber) with urine produced by the subject. When the signal exceeds a first predetermined threshold 120, the controller activates the pump such that it begins pumping urine through the conduit, as indicated by a second portion 118b of the signal.

[0417] In some embodiments, the controller causes the pump to pump a predefined number of strokes, as shown in Figure 19. Following the predefined number of strokes, urine again accumulates until the pump is triggered again.

[0418] In other embodiments, the controller stops the pump in response to a signal exceeding the first threshold 120 in the opposite direction. For example, if the pump was started in response to a signal exceeding the first threshold, the pump may be stopped in response to a signal falling below the first threshold. (In such an embodiment, the signal 118 remains within a narrow range that straddles the first threshold 120.)

[0419] Alternatively, the controller may stop the pump in response to a signal exceeding a second predefined threshold 121 in a second direction after exceeding a first threshold 120 in a second direction. For example, if the pump was started in response to a signal exceeding a first threshold, the pump may be stopped in response to a signal falling below the first threshold 120 and then below the second threshold 121.

[0420] Alternatively, the controller may stop the pump in response to the pump having pumped a predefined amount of urine.

[0421] In some embodiments, the controller dynamically redefines the first threshold 120 and / or the second threshold 121, for example, to balance the objectives of keeping the bladder relatively empty (e.g., less than 20 ml of urine) with the objective of preventing bladder tissue from clogging the urinary catheter. For example, if the controller determines that bladder tissue has been aspirated into the catheter (e.g., as described in the "Pressure and Flow Regulation and Suction Relief" section below), the controller may increase the first threshold 120 and / or the second threshold 121.

[0422] Calculate the pumping volume

[0423] Typically, the pump is pre-calibrated and the results of the calibration are stored, for example, in NVM 190 (FIG. 31). Using these calibration results, the controller can accurately calculate the volume of urine pumped.

[0424] Typically, the calibration results include a function or look-up table that maps one or more parameters to the volume of urine pumped. The parameters may include the "size" of the stroke, such as (i) the angle the rotor of the peristaltic pump has rotated, (ii) the distance the plunger has advanced against the movable wall of the pump chamber, or (iii) the amount of increased air or hydraulic pressure pushing against the movable wall. The parameters may also include one or more of the following: ambient temperature, pressure upstream from the pump, pressure downstream from the pump, time since the previous stroke, urine temperature, urine composition, and urine viscosity.

[0425] Ambient temperature may be determined by a temperature sensor in the control unit. Urine temperature may be determined by a temperature sensor located in the conduit 371 (FIG. 66A), e.g., in the catheter connector of FIG. 40, or fixed to the exterior of the conduit.

[0426] To determine the pressure upstream and / or downstream from the pump, the inlet and / or outlet of the pump may have a thin wall and a strain gauge may measure the deformation of the thin wall as a function of pressure. Alternatively, the deformation may be measured in other ways, for example as described above for various sensors within the scope of the present invention. Alternatively, the downstream pressure may be calculated based on the amount of current consumed by the pump actuator during each pump stroke. (Higher current indicates higher resistance and therefore higher downstream pressure.)

[0427] The time since the previous stroke may be tracked and recorded by the controller during operation.

[0428] Urine composition may be measured by spectroscopy and / or microscopy. Urine viscosity may be measured by processing images of urine taken by a camera upstream from the pump during and after the pump stroke. (Such processing may be performed by the controller or by a separate processor.) In particular, based on the images, a flow profile may be calculated and viscosity may be calculated based on the rate and duration of flow (less viscous fluids flow faster for short times, more viscous fluids flow slower for longer times). Alternatively or additionally, viscosity may be calculated based on the pressure change profile during and immediately after the stroke (less viscous fluids have faster pressure changes, more viscous fluids have slower pressure changes).

[0429] In the case of a peristaltic pump, the parameters may further include the physical dimensions and Shore hardness of the peristaltic pump tubing, the time the tubing has remained squeezed in the pump, and the number of previous strokes the tubing has experienced. The physical dimensions and Shore hardness of the tubing may be determined at the time of manufacture and may be stored in the disposable kit, such as in or on the cartridge 374 (FIG. 66A). The storage medium may include a bar code, a quick response (QR) code, an engraved or printed string of characters, a non-volatile memory (e.g., a read only memory (ROM)), or a radio frequency identification (RFID) tag. The control unit may have a reader configured to read this information from the storage medium. The time the tubing has remained squeezed and the number of previous strokes the tubing has experienced may be tracked and recorded by the controller during operation.

[0430] Similarly, for a reciprocating pump configured to press against a diaphragm (e.g., according to Figs. 63A-B), the parameters may further include the physical dimensions and Shore hardness of the diaphragm, the time the diaphragm has remained pressed, and the number of previous strokes the diaphragm has undergone. These parameters may be determined and stored as described above.

[0431] Refer again to Figure 66B.

[0432] In some embodiments, when a urine sample is required, the nurse (or other user) sends input to the controller (e.g., via the display 378 and / or keyboard) indicating the intended volume of the sample. In response, the controller calculates the amount of time required for the specified volume of urine to accumulate in the bladder based on the current urine production rate. After stopping the pump for this amount of time, the controller notifies the nurse (e.g., via the display 378) that a sample may be taken via the sampling port 372. After the nurse confirms that the specimen has been taken, normal pumping operation resumes. The controller then adds the sample volume to the total pump volume when calculating urine production.

[0433] In other embodiments, the nurse may optionally enter an input indicating the nurse's intent to extract a urine sample, but the nurse need not indicate the intended sample volume. Instead, as urine is extracted, the controller causes the pump to pump urine upstream, thereby compensating for the extracted urine. For example, the controller may initiate upstream pumping in response to the upstream pressure dropping below a predetermined threshold (e.g., threshold 121 (FIG. 19)) and continue upstream pumping to maintain the pressure above the threshold.

[0434] Pressure and flow regulation and suction relief

[0435] Reference is now made to FIG. 25, which is a schematic diagram of a system 96 according to some embodiments of the present invention.

[0436] In some cases, the walls of the bladder 122 may be sucked into the catheter 124, thereby inhibiting urine flow from the bladder until enough urine (and therefore pressure) accumulates in the bladder to separate the bladder walls from the catheter. To address this problem, some embodiments of the present invention provide a pressure valve 142 configured to reduce suction forces on the bladder. The pressure valve 142 is typically coupled to the downstream end of the catheter connector 72, for example, between the catheter connector and the tube 28. Alternatively, the pressure valve may be integral with the catheter connector.

[0437] Note that pressure valve 142 may be implemented whether urine is pumped or drained (via gravity) from the bladder. (When draining urine, the suction pressure in the bladder can be particularly high, e.g., 100 mbar. Thus, suction of the bladder wall onto the catheter can not only impede urine flow, but can also harm the bladder.)

[0438] Reference is now made to additional Figures 24A-C, which are schematic illustrations of a pressure valve 142, according to some embodiments of the present invention.

[0439] In some embodiments, the conduit 371 comprises a first tube 145 configured to carry urine downstream from the subject's bladder and a second tube coupled to the first tube 145 and configured to carry urine downstream from the first tube. For example, as shown in FIG. 25, the second tube may comprise a tube 28 configured to carry urine downstream to a reservoir or pump. Alternatively, in embodiments in which the tube 28 is omitted, the second tube may comprise an outlet tube 29 (or a multi-lumen tube having a urinary lumen) coupled to the first tube (via a pump) and configured to carry urine downstream to a urine collection bag. Similarly, in embodiments in which urine is drained, the second tube may be configured to carry urine downstream to a urine collection bag.

[0440] The first tube 145 functions as a pressure valve 142, with the first tube having one or more flexible walls 148 configured to collapse into the first tube when pressure within the first tube is reduced until the first tube is closed. Closing the first tube separates the upstream side (US) from the downstream side (DS) of the tube, thereby relieving the upstream side from suction pressure (and also stopping the flow of urine through the tube).

[0441] For example, in Figure 24A, the internal pressure within the pressure valve is relatively high (i.e., the bladder suction pressure is relatively low), resulting in the pressure valve being mostly open, while in Figure 24B, the internal pressure is low (i.e., the bladder suction pressure is high), resulting in the pressure valve being closed, thus separating the upstream and downstream sides of the valve.

[0442] In some embodiments, as shown in FIG. 24C, the upstream portion of flexible wall 148 is more flexible than the downstream portion of flexible wall 148, for example, by the flexible wall being thinner upstream than downstream. Thus, even though the valve is closed, a relatively small increase in upstream pressure due to urine production will cause the valve to reopen slightly, thus allowing some urine to flow downstream. Following urine flow downstream, the upstream pressure will decrease, causing the valve to close again. This process can be repeated any number of times until the downstream pressure increases sufficiently to keep the valve open.

[0443] Reference is now made to Figure 24D, which is a schematic illustration of a cross-section through prior art tube 144 in an inflated and deflated state, and Figure 24E, which is a schematic illustration of a cross-section through first tube 145, according to some embodiments of the present invention.

[0444] The right side of Figure 24D shows the prior art tube 144 in an open (relaxed) state at a relatively high internal pressure, while the left side of Figure 24D shows the prior art tube 144 in a collapsed state at a lower internal pressure (higher suction). Even when the tube 144 is collapsed, the side channel 146 remains, making the tube 144 unsuitable for use as a pressure valve.

[0445] On the other hand, the first tube 145 is of a different construction than the prior art tube 144 in that the first tube is configured to collapse without leaving an open side channel 146. For example, in some embodiments, the flexible wall 148 has a first wall 148a having a first surface 149a and a second wall 148b having a second surface 149b. The second surface 149b is coupled to the first surface 149a at opposing edges of the first surface such that when pressure between the first wall 148a and the second wall 148b is reduced, the walls collapse towards each other until the first and second surfaces completely contact each other between the edges, as shown on the left side of FIG. 24E. In this collapsed state, the first tube 145 completely separates the upstream US from the downstream DS.

[0446] In some embodiments, the first tube 145 also functions as a reservoir in that the first tube may expand as urine flows through it. In such embodiments, the sensor 50 may be positioned adjacent to the first tube 145 and the separate reservoir 40 shown in FIG. 25 may be omitted.

[0447] Reference is now made to FIG. 26, which is a schematic diagram of a system 96 according to some embodiments of the present invention.

[0448] In some embodiments, system 96 includes a suction relief mechanism 150 having a suction relief tube 152, a plunger 154, and a counter pressure fixture 156. The suction relief tube 152 may be connected to the downstream end of the tube 28, for example, between the tube 28 and the pump. Typically, the suction relief tube 152 is more flexible than the tube 28, for example, by having a thinner wall. It should be noted that the suction relief mechanism 150 may be implemented regardless of whether urine is pumped or drained (via gravity) from the bladder.

[0449] In some cases, the controller may determine (e.g., based on a signal received from the sensor 50) that urine has at least partially stopped flowing downstream from the bladder 122 through the conduit 371. The cessation of flow may indicate that bladder tissue has been aspirated into the urinary catheter.

[0450] In such an embodiment, the controller may stop pumping urine in response to identifying a cessation of flow. Additionally, whether urine is being pumped from the bladder or simply drained, the controller may increase pressure in the conduit to release the bladder tissue from the catheter.

[0451] For example, the controller may increase pressure by pushing on the conduit. For example, the controller may drive the plunger 154 against the suction relief tube 152 such that the suction relief tube is squeezed between the plunger and the counter pressure fixture 156. When the suction relief tube is squeezed, urine may flow upstream towards the bladder.

[0452] After pushing the tube, the controller determines (e.g., based on a sensor signal) that urine flow from the bladder has resumed. In response, the controller may stop increasing pressure, for example, by stopping advancing the plunger. The controller may then gradually withdraw the plunger, thus allowing the suction relief tube to re-expand. For example, the controller may withdraw the plunger at a rate proportional to the flow rate of urine into the reservoir 40. In embodiments in which urine is pumped, the controller may resume pumping urine downstream, for example, following withdrawal of the plunger, in response to determining that urine has resumed flowing from the bladder.

[0453] In embodiments in which urine is pumped, the controller may increase the pressure in the conduit upstream from the pump by operating the pump in the reverse direction, i.e., the upstream pumping direction, instead of or in addition to using the suction relief mechanism 150. By operating the pump in the reverse direction, the controller may force urine to flow upstream.

[0454] Reference is now made further to FIG. 27, which illustrates a schematic of an exemplary performance of suction relief according to some embodiments of the present invention.

[0455] FIG. 27 shows a lower plot 158 ​​that tracks the reservoir volume over time and an upper plot 160 that tracks the position of the plunger 154 (in embodiments where a plunger is used to increase the pressure in the conduit) or the pump (in embodiments where the pressure is increased by reversing the pump).

[0456] As shown in plot 158, during time period A, the reservoir fills until its volume reaches threshold B. In response to the volume reaching the threshold, the controller causes the pump to pump one or more (forward) strokes until the reservoir returns to its initial volume. Thereafter, as a result of the suction created by the pumping strokes, the bladder tissue blocks the urinary catheter from flowing into the reservoir during time period C. In response to detecting the cessation of flow, the controller drives the plunger in a reverse direction relative to the suction relief tube or pump from time 1 to time 2, thus expanding the reservoir beyond threshold volume B. During this time, the controller registers the reservoir volume as a function of the position of the plunger or pump. In response to the reservoir volume increasing by more than the amount of urine pushed upstream by the plunger or pump, the controller may determine that suction relief was successful.

[0457] In response to determining that suction relief was successful and that the reservoir is no longer expanding shortly after time point 2, the controller holds the plunger or pump in place until time point 3. The controller then begins withdrawing or pumping the plunger forward. Prior to an initial time point 4, the volume of the reservoir remains constant because urine withdrawn from the reservoir is replaced with an equivalent amount from the bladder. At subsequent time point 4, the bladder is empty and so the volume of the reservoir decreases.

[0458] At time 5, bladder tissue is again aspirated into the urinary catheter. As a result, the reservoir volume stops decreasing. In response, at time 6, the controller again begins advancing the plunger or reversing the pump. At time 7, the controller begins withdrawing the plunger or pumping in a forward direction until the plunger or pump reaches its initial position at time 8. The controller then operates the pump normally.

[0459] As shown, at time point 8, reservoir volume D is greater than threshold B. Thus, the pump stroke(s) empty the reservoir to volume E, which is greater than the volume during period C. However, after period F, the volume reaches threshold B, and the pump empties the reservoir until the volume is reduced to the volume of period C.

[0460] Reference is now made to FIG. 37, which is a schematic illustration of a disposable kit 370 having a pressure regulating bypass tube 240 according to some embodiments of the present invention.

[0461] In some embodiments, the disposable kit 370 includes a bypass tube 240. The upstream end of the bypass tube 240 is connected to the tube 28 (upstream of the conduit section 31) at a junction 242. The downstream end of the bypass tube may be connected to a part of the kit downstream from the conduit section, such as the connector 134, the outlet tube 29, or the urine collection bag 78. Alternatively, the downstream end of the bypass tube may be connected to a separate urine collection container.

[0462] In such an embodiment, the disposable kit 370 further includes a pressure relief valve 244 configured to prevent the flow of urine through the bypass tube when the pressure in the bypass tube is below a predetermined threshold and to allow the flow of urine to bypass the conduit section when the pressure exceeds the threshold.

[0463] Thus, as long as the pressure is low enough, valve 244 remains closed so that urine may be pumped through the conduit. On the other hand, if the pump stops pumping urine (e.g., due to mechanical failure of the pump, failure of the controller, or blockage of the conduit downstream from junction 242), the accumulation of urine causes a rise in pressure at the pressure relief valve inlet. When the pressure passes a threshold, the pressure relief valve opens, thereby allowing the downstream flow of urine through bypass tube 240.

[0464] In embodiments in which the bypass tubing is connected to connector 134 such that the bypass tubing passes between tubing 28 and the connector, valve 244 may be integrated into the connector. Alternatively, valve 244 may be coupled to any portion of the bypass tubing, such as the upstream end of the bypass tubing at junction 242, regardless of whether the bypass tubing is connected to connector 134 or not.

[0465] Measure intra-abdominal pressure (IAP)

[0466] Reference is now made to FIG. 28, which is a schematic diagram of a system 96 according to some embodiments of the present invention.

[0467] By way of introduction, it is noted that a subject's IAP can be measured by measuring the subject's intravesical pressure at the end of expiration when the bladder contains a predefined volume of fluid. Typically, this volume depends on the subject's weight; for example, for an adult subject of average weight, the volume is approximately 20-25 ml.

[0468] In some embodiments, the controller 125 is configured to measure the subject's IAP in response to instructions from a user. The instructions may be received via any suitable user interface to which the controller is connected, such as a touch screen associated with the display 378 (FIG. 66B) or a keyboard. The user may instruct the controller to measure the IAP once or periodically at a user-defined rate.

[0469] In such an embodiment, the controller first empties the bladder 122 by pumping urine from the bladder. (The bladder may be emptied prior to receiving the instruction.) For example, the controller may empty the bladder based on a signal from pressure sensor 88 or sensor 50, as described above in the section entitled "Pump Control." The controller further calculates an estimated time from bladder emptying required for a predefined amount of urine to flow from the subject's kidneys into the bladder based on the subject's urine production rate.

[0470] (In practice, it may not be possible to literally empty all the urine from the bladder, so it should be understood that in the context of this application, including the claims, using a pump to "empty" the bladder means pumping as much urine as possible from the bladder, e.g., such that the amount of remaining urine that cannot be pumped from the bladder is less than 20 ml, such as less than 10 ml.)

[0471] After emptying the bladder, the controller refrains from pumping urine for an estimated period of time (hereinafter also referred to as the "wait time"), thereby allowing urine to accumulate in the bladder, and in embodiments in which the conduit 371 includes a reservoir 40, in the reservoir 40.

[0472] After an estimated time has elapsed, the controller receives a signal that varies in response to pressure within the bladder. Based on the signal, the controller ascertains pressure within the bladder.

[0473] For example, pressure sensor 88 may be coupled to a urinary catheter, as described above with reference to Figure 30, such that the pressure sensor senses the pressure at the outlet of the catheter. When the pressure sensor is at a predefined height such that the difference between the outlet pressure and the intravesical pressure is known, the controller may ascertain the pressure in the bladder based on the value of the signal.

[0474] Alternatively, pressure sensor 88 may be coupled to a fluid filled tube in which the pressure varies as a function of the pressure in the bladder, for example according to any of Figures 13, 50-51, 58, 61 and 67. In such an embodiment, the controller may ascertain the pressure in the bladder by applying a function to the value of the sensor signal. The function may be pre-calibrated and stored in a memory, for example, NVM 190 (Figure 31).

[0475] As yet another alternative, the controller may receive a signal from a sensor monitoring the reservoir, for example according to any of Figures 12A-B, 20 and 22. Given that the reservoir expands as a function of pressure in the bladder, the controller may ascertain the pressure in the bladder by applying a function to the value of the sensor signal. The function may be pre-calibrated and stored in a memory, for example NVM 190 (Figure 31).

[0476] After receiving the signal, the controller may generate an output indicating that the pressure in the bladder indicated by the signal is the subject's IAP. The controller may then display the output on display 378 (FIG. 66B) or any other suitable display. Alternatively or additionally, the controller may communicate the IAP to a patient monitor, EMR, gateway, or other device or system, such as a physician's desktop computer, cell phone, or tablet computer.

[0477] For example, the output may include a numerical value of the pressure along with "IAP" or any other suitable descriptive string. If the IAP is measured periodically, the output may include a plot of the IAP over time.

[0478] Typically, the subject's breathing results in fluctuations in intravesical pressure. As described above, the IAP is measured at the end of expiration when the pressure reaches a local minimum. Thus, the controller may sample the signal periodically, for example, at a rate of 10 times per second. (The controller may start sampling the signal even before the waiting time has elapsed.) Based on the sampled pressure values ​​(e.g., based on the frequency spectrum of the samples), the controller may estimate the subject's breathing rate. Based on the estimated breathing rate, the controller may estimate the time t0 at which expiration ends, following the waiting time. The controller may then select the first local minimum of pressure within a predefined period t0 as the IAP.

[0479] Advantageously, this technique for measuring IAP does not require the injection of saline into the bladder, as is required by conventional techniques (note that aside from the hassle and discomfort associated with the saline injection itself, the injection requires waiting 30-60 seconds for the subject's detrusor muscle to relax before measuring IAP).

[0480] Typically, in embodiments in which the controller maintains a relatively empty bladder during normal operation of the pump, the controller calculates the wait time based on the amount of urine pumped during the preceding period. For example, if a volume W of urine was pumped during the preceding period of length T, the controller may calculate the subject's urine production rate as W / T. Denoting the target volume for IAP measurement as V, the controller may calculate the wait time as V*T / W.

[0481] In some embodiments, before generating the output, the controller verifies that the measured pressure is indeed intraperitoneal pressure. The controller generates the output in response to the verification.

[0482] To perform the verification, the controller first uses the pump to re-empty the bladder. The controller then verifies that the amount of urine pumped from the bladder during the re-emptying deviates from a predefined volume V by less than a predefined threshold. In some embodiments, the predefined threshold is a percentage of V.

[0483] In some embodiments, the controller estimates the subject's respiration rate based on the intravesical pressure signal without measuring IAP (as described above). Alternatively or additionally, given that intravesical pressure varies with the subject's cardiac cycle, the controller may estimate the subject's heart rate based on the intravesical pressure samples (e.g., based on a frequency spectrum of the samples). The respiration rate and / or heart rate may be displayed and / or communicated as described above for IAP.

[0484] For further details regarding IAP measurement, refer to FIG. 29, which shows a flow diagram of an algorithm 164 for measuring IAP according to some embodiments of the present invention.

[0485] The algorithm 164 begins with a determine rate step 166, where the controller calculates the rate X of urine production over the preceding period of time, for example in units of ml / h. After emptying the bladder, the controller stops the pump in a stop pump step 168.

[0486] As mentioned above, for IAP measurement, the amount of urine in the bladder must be allowed to reach a predetermined volume V, which, as mentioned above, may be between 20 and 25 ml for some subjects. Thus, the controller waits V / X time during wait step 170 - i.e. keeps the pump stopped. For example, if X is in ml / h and V is in ml, the controller may wait 60*V / X minutes. Then, in pressure measurement step 172, the pressure at the end of expiration of the subject is taken as the IAP.

[0487] Then, in a resume step 174, the operation of the pump is resumed. In another wait step 176, the controller waits for the pump to stop, i.e., the controller waits until all urine has been pumped from the bladder. Then, in a calculation step 178, the controller calculates the amount of urine pumped from the bladder during the wait step 176. Then, in a check step 180, the controller checks whether the calculated amount is between V-α and V+α, where α is, for example, a predefined percentage of V (e.g., 25%). If the calculated amount is within these bounds, the controller displays the IAP in a display step 182. If not, the controller returns to the stop step 168 and repeats the measurement.

[0488] In other embodiments, the controller stops the pump slightly longer than the calculated wait time to allow, for example, an additional 5-15 ml to accumulate in the bladder. The controller then pumps urine from the bladder while measuring the intravesical pressure. After emptying the bladder, the controller identifies a period during which the amount of urine in the bladder was V based on the known amount of urine pumped during each stroke. The controller then identifies the intravesical pressure during this period when the subject was at end-expiration as the IAP.

[0489] In yet another embodiment, rather than waiting for the calculated wait time to elapse, the controller simply stops the pump and samples the intravesical pressure until the pressure stops increasing, In response to determining that the pressure has stopped increasing, the controller identifies the pressure at the next end expiratory event as the IAP.

[0490] In yet another embodiment, after the bladder is emptied, the controller causes the pump to pump a volume V into the bladder. After 30-60 seconds, which is required for the subject's detrusor muscle to relax, the controller identifies the pressure at the next end-expiratory event as the IAP.

[0491] caveat

[0492] As described throughout this application, in some embodiments, the controller is configured to pump urine from the subject's bladder by controlling the pump. In such embodiments, the controller may be configured to generate an alert indicating a current or upcoming interruption to pumping, which may include an obstructed flow of urine upstream or downstream from the pump. The alert may include a visual alert (e.g., a message displayed on a computer monitor and / or delivered to a mobile phone) and / or an audio alert (e.g., a beep).

[0493] For example, the controller may generate an alert in response to an increase in the amount of power consumed by the pump, which indicates an increase in resistance to urine flow downstream from the pump, for example, due to a full collection bag 78 (FIG. 30) or due to an obstruction in the outlet tube 29 (FIG. 30). (In the context of this application, including the claims, an obstruction in a particular conduit may include, for example, a kinked tube or a solid object such as a blood clot or kidney stone lodged in the conduit.)

[0494] In other words, while the pump is running, the controller may monitor the amount of power consumed by the pump (particularly by the pump's actuator), for example, by integrating the current draw over time. The controller may then compare this amount of power to a baseline amount of power. (The baseline may change over time, for example, due to wear in the peristaltic tubing.) If the usage exceeds the baseline, the controller may generate an alert.

[0495] As another example, the controller may generate an alert in response to the collection bag being nearly full, i.e., the difference between the collection bag's maximum capacity C and the amount of urine pumped A (as calculated by the controller) is less than a predefined threshold T. (It is noted that the controller does not necessarily have to explicitly calculate CA and compare this difference to T. Rather, the controller simply compares A with CT and generates an alert if A exceeds CT.)

[0496] In some cases, an obstruction in the conduit upstream of the pump or in the urinary catheter can impede the flow of urine to the pump. Such obstructions can include, for example, kinks or solid objects such as blood clots or kidney stones. As described below, the controller can use various techniques to identify the presence of such obstructions and generate an alert accordingly.

[0497] For example, in embodiments where the pump has a pump chamber (e.g., as in FIG. 67), the controller may monitor the amount of urine flowing into the pump chamber (e.g., based on the position of plunger 350). The controller may further calculate a minimum amount of urine expected to flow into the pump chamber, taking into account the operation of the pump and expected urine production. If the flow rate falls below this estimated amount, the controller may generate an alert.

[0498] Alternatively, if the conduit includes a reservoir (eg, as in FIG. 23), the controller may generate an obstruction warning based on the amount of urine flowing into or out of the reservoir.

[0499] In particular, if the blockage is downstream from the reservoir, the controller may generate an alert in response to a signal indicating that the amount of urine flowing from the reservoir (i.e., the total flow out, which may be greater than the net change in the amount of urine in the reservoir) is less than the pumping volume of the pump, i.e., the amount the pump would have pumped if flow through the conduit was not inhibited. (The pumping volume may be calculated as described in the "Calculating the Pumping Volume" section above.) For example, in embodiments in which the reservoir is expandable and the sensor 50 (FIG. 23) detects the relative expansion or contraction of the reservoir, the controller may calculate the minimum amount that the reservoir is expected to contract, taking into account the operation of the pump and expected urine production. If the signal from the sensor 50 indicates that the reservoir will contract less than this estimated amount, the controller may generate an alert.

[0500] On the other hand, if the blockage is upstream from the reservoir, the controller may generate an alert in response to a signal indicating that the increase in the volume of urine in the reservoir is below a predefined threshold. For example, the controller may calculate a minimum amount that the volume of urine in the reservoir is expected to increase to over a period of time based on the recent rate of urine production. If the increase falls below this estimated amount over a period of time (when the pump is typically idle), the controller may generate an alert.

[0501] Alternatively, if a pressure sensor is coupled to the conduit to sense the pressure in the conduit or a fluid pressure that changes in response to the pressure in the conduit (e.g., as in FIG. 58), the controller may generate an occlusion warning based on the pressure.

[0502] In particular, if an occlusion is downstream of the pressure sensor, the controller may generate an alert in response to a change in pressure. For example, the controller may calculate a minimum amount that the pressure is expected to drop, taking into account the operation of the pump and expected urine production. If the pressure drop falls below this estimated value, the controller may generate an alert.

[0503] On the other hand, if the blockage is upstream of the pressure sensor, the controller may generate an alert in response to the pressure rise falling below a predefined threshold. For example, the controller may calculate the minimum amount that the pressure is expected to rise over a period of time based on the recent urine production rate. If the rise falls below this estimated value over a period of time (during which the pump is typically idle), the controller may generate an alert.

[0504] In this regard, reference is made to Fig. 32, which illustrates a flow diagram of a control and warning algorithm 200 executed by the controller, according to some embodiments of the present invention. The control and warning algorithm 200 includes a sampling step 110, an evaluation step 112, and a pump activation step 114, as described above for the algorithm 108 with reference to Fig. 18. Furthermore, in accordance with the algorithm 200, the controller executes several successive steps in parallel with each other following the pump activation step 114. In particular:

[0505] (i) In a first series of steps, the controller checks for obstructions upstream of the pump and warns the user of any such obstructions.

[0506] First, the controller samples the sensor again in sampling step 110. Then, the controller checks in check step 202 whether the sensor output indicates that the reservoir has responded to the pump stroke, i.e., whether the outflow from the reservoir is within a predefined (small) deviation of the pumping volume of the pump. To estimate the outflow, the controller may estimate the volume of urine produced since the most recent pump activation and subtract from this estimate the net change in reservoir volume (which may be a negative number).

[0507] If the reservoir does not respond to a pump stroke, there is a high probability that there is a kink (or another obstruction) in the tube 28 (FIG. 66A) passing between the reservoir and the pump. The controller therefore displays a tube kink warning (or a more general blockage warning) in a warning step 204. Otherwise, the controller checks in another check step 206 whether the expected amount of urine has flowed into the reservoir. If yes, the controller returns to the initial sampling step 110. If not, it is likely that the urinary catheter (or the conduit upstream from the reservoir) is clogged. The controller therefore displays a catheter blockage warning (or a more general blockage warning) in another warning step 208. Optionally, before generating the warning, the controller may increase the pressure in the conduit upstream from the pump if the cessation of flow is due to suction acting on the bladder, as described above with reference to FIG. 26 for example. If the flow then resumes, the warning may be omitted.

[0508] (ii) In a second series of steps, the controller calculates various flow parameters and also checks whether the urine collection bag is nearly full.

[0509] First, the controller performs a recording step 116, as described above with reference to Figure 18. Then, in a calculation step 210, the controller calculates the volume and flow rate of urine flowing through the pump, as well as the volume of accumulated urine in the collection bag. The controller then displays one or more of these parameters in a display step 212. Furthermore, the controller checks whether the collection bag is nearly full in another check step 214. If yes, the controller displays an appropriate warning in another warning step 216.

[0510] (iii) In a third series of steps, the controller checks the amplitude of the current driving the pump in another check step 218. If the amplitude is higher than a predefined threshold, the urine collection bag is likely full and, as a result, the pump is encountering more resistance. Therefore, the controller displays an appropriate warning in another warning step 220.

[0511] Reference is now made to FIG. 33, which illustrates a plot 222 tracking reservoir volume over time, according to some embodiments of the present invention.

[0512] Plot 222 is similar to the plot of Figure 19 in that it shows the time when the pump stroke begins. However, plot 222 also shows two cases in which a problem may be detected as described above with reference to Figure 32: in the first case, there is a kink in the tubing, so urine is not pumped out of the reservoir and the reservoir continues to fill, and in the second case, the catheter is clogged, so that the reservoir does not refill.

[0513] Noise filtering and display of output

[0514] Reference is now made to FIG. 49, which is a schematic illustration of a system 246 for displaying urine production parameters according to some embodiments of the present invention.

[0515] System 246 includes a urine production measurement system 248 configured to measure the amount of urine produced by the subject over time and calculate the rate at which urine is produced as a function of time. In some embodiments, urine production measurement system 248 includes urinary catheter 124, tubing 28, and connector 72, or is connected to urinary catheter 124 via tubing 28 and connector 72. In some embodiments, urine production measurement system 248 includes one or more components of system 96, such as pump 20 and / or controller 125 (FIG. 66B).

[0516] In general, urine production measurements can be distorted by many factors. Such factors may include, for example, the subject's cardiac and respiratory activity, bowel motility, physical movement, and obstruction of the catheter 124 (e.g., by bladder tissue). Thus, the output of the urine production measurement system 248 is a superposition of a clean signal representing the true rate of urine production as a function of time, and additive noise. In other words, the signal calculated by the urine production measurement system representing the rate of urine production by the subject's kidneys as a function of time is a noisy signal.

[0517] To address this challenge, the system 246 further includes a filtering module 250 configured to receive a noisy output signal from the urine production measurement system and filter noise from the noisy signal to obtain a clean signal. In some embodiments, the implementation of the filtering module 250 includes applying a low pass filter to the noisy signal, given that the noise is generally at a higher frequency than the clean signal. Alternatively or additionally, the filtering module 250 may include a neural network trained to filter the noise.

[0518] In some embodiments, the filtering module is performed by the urine production measurement system, e.g., controller 125 (FIG. 66B). In other embodiments, as shown in FIG. 49 and contemplated below, the filtering module 250 is performed by a processor external to the urine production measurement system 248, such as processor 127 (FIG. 20).

[0519] After filtering the signal, as described below with reference to FIG. 56, the filtering module, or another module executed by the processor, may calculate a representative rate of change of the clean signal over at least 12 hours. The processor may then generate an output, including, for example, a graphical output, showing the representative rate of change. (Typically, the processor displays a plot of the clean signal and marks the representative rate of change on the plot, as described below with reference to FIG. 56.) The processor may then display the output on the patient monitor 252 and / or other display 254 (e.g., display 378 (FIG. 66B)) and / or communicate the output to a device such as the EMR 256, a gateway, a nurse's station monitor, and / or a cell phone or tablet.

[0520] Reference is now made further to FIG. 56, which is a schematic illustration of a display output 320 according to some embodiments of the present invention.

[0521] In general, given that urine production rate may vary due to various factors (e.g., related to drug or fluid administration), it is difficult to manually identify trends in rate. To address this challenge, the filtering module (or another module) may calculate a representative rate of change of rate, for example, by applying linear regression or a trained neural network to the clean signal representing the rate.

[0522] As an example, Figure 56 shows a plot 322 of a subject's urine production rate over several days. From days 4 through 8, there is a trend toward decreased urine production that may be difficult to identify manually. For example, point 326 on day 5 is higher than point 324 on day 4, point 328 on day 6 is approximately the same value as point 324, and point 330 a few hours later is higher than point 324. However, the trend line 332 calculated and displayed by the processor clearly shows a negative representative rate of change of approximately -50 ml / h / day.

[0523] In some embodiments, the processor is further configured to generate an alert in response to a magnitude (i.e., absolute value) of the representative rate of change exceeding a predefined threshold. For example, the processor may generate an alert in response to the representative rate of change being greater than R1 ml / h / h or less than -R2 ml / h / h, where R1 and R2 are positive and, optionally, equal to one another.

[0524] Reference is now made to FIG. 35, which is a schematic diagram of an exemplary output 224 that may be displayed by the controller on a display 378 (FIG. 66B) and / or other display (such as a patient monitor, mobile phone or tablet display) in accordance with some embodiments of the present invention.

[0525] In this example, the bars 226 show the hourly volume of urine production for a previous period, which may be selected by the user by clicking on the appropriate tab 228. (The right-most bar 226r shows the volume produced since the start of the current hour.) For example, selecting the 6-hour (6H) tab allows the user to see the hourly volume for the past 6 hours. Alternatively, the user may select the past 1-hour (1H), 12-hour (12H), 24-hour (24H), or a period from the start of the current shift. In some embodiments, if the past period selected is 1 hour or less, the volume is displayed at a 5-minute resolution; that is, each bar shows the volume of urine production for 5 minutes.

[0526] Optionally, output 224 may further include an indicator of the subject's weight 230, which may be entered, for example, by a nurse. Alternatively or additionally, the display may include an indicator of the subject's core temperature 232, which may be measured, for example, as described below with reference to FIG. 40. Alternatively or additionally, for a selected past period of time, output 224 may include average urine production rate per body weight 234 (e.g., in ml / kg / h), average urine production rate 236, and / or total urine production 238. In some embodiments, output 224 includes total urine production for the past 60 minutes, regardless of the tab selected.

[0527] Bag connector for replaceable fluid bags

[0528] 22, in some embodiments, the outlet tube 29 is connected to a urine collection bag 78 via a connector 134, a bag connector 136, and a connecting tube 135. In such embodiments, when the urine collection bag 78 becomes full, it can be replaced with a new bag without having to replace the entire disposable kit and without having to empty the bag.

[0529] More generally, this type of connection may be used with any replaceable fluid bag, and therefore, hereinafter, the more general terms "fluid bag" or "replaceable fluid bag" will be used instead of "urine collection bag."

[0530] In this regard, reference is made to Fig. 34A, which is a schematic side view of a replaceable fluid bag 78 with a non-spill connector 134, according to some embodiments of the present invention, and Fig. 34B, which is a schematic detailed view of the non-spill connector of Fig. 34A, and Figs. 34C and 34D, which are schematic front views of the non-spill connector 134 in closed and open configurations, respectively.

[0531] The connector 134 in this embodiment is a non-spill female connector secured to the downstream end of the outlet tube 29, which receives fluid output (such as urine) by the subject through its upstream end. The connector 134 has a number of flexible leaves 500 that close together across the connector to prevent fluid from exiting, as shown in FIG. 34C. The leaves 500 have sections (e.g., quadrants) of a polymer diaphragm made from rubber or silicone that extend across the connector 134. The bag connector 136 is a male connector that is inserted into the connector 134, thus opening the flexible leaves by pushing the leaves inwards, as shown in FIG. 34D. Fluid can then flow from the outlet tube 29 through the connecting tube 135 to the fluid bag 78, which is secured to the bag connector 136 (via the connecting tube 135) to receive and store the fluid exiting the outlet tube.

[0532] In other embodiments, connector 134 is male and connector 136 is female.

[0533] In yet other embodiments, connector 134 and connector 136 are genderless. For example, a lock, including, for example, a snap, may lock the connectors together. Optionally, in such embodiments, the connectors may be sealed to one another via an O-ring seal.

[0534] In some embodiments, the connectors are mated together by pushing one connector towards the other, while in other embodiments, the connectors are mated together by rotating one connector relative to the other (e.g., by a quarter turn).

[0535] In another embodiment, the connector 134 is not a non-spill connector.

[0536] Catheter tube connector with temperature sensor

[0537] FIG. 40 is a schematic side view of a catheter connector 72 with an integrated temperature sensor 505, according to some embodiments of the present invention.

[0538] Connector 72 has an upstream end 502 for connection to a urinary catheter. A tube 504 is connected to the downstream end of connector 72 to receive urine flowing through the catheter. (An example of a tube 504 is tube 28 of FIG. 30.) A temperature sensor 505 is operatively associated with connector 72. For example, as shown in FIG. 40, temperature sensor 505 may be integral with the connector. Alternatively, the temperature sensor may be near the connector, for example, by being integral with a sampling port coupled to the connector, or by being located in a separate housing coupled to the connector directly or via a short tube.

[0539] Temperature sensor 505 senses the temperature of the urine flowing into tube 504. In the illustrated embodiment, temperature sensor 505 is housed within connector 72 and includes an electrical sensor, such as a thermocouple, that outputs an electrical signal indicative of the temperature of the urine. Alternatively, other types of temperature sensors may be used and the temperature sensor may be located either within the connector or outside the connector.

[0540] Wires 506 are connected to temperature sensor 505 and extend along tube 504 to transmit electrical signals to measurement circuitry, such as a monitor or other device (not shown in this view) for displaying and / or recording the subject's temperature. Wires 506 may be integral to tube 504, for example, by passing through the wall of the tube or through the lumen of the tube and terminating at the downstream end of the tube.

[0541] The upstream end 502 of the catheter connector 72 plugs into a urinary catheter 124 (FIG. 37), such as a Foley catheter. The connector 72 may have a sampling port 372 for obtaining a urine sample. The sensor 505 may include a thermocouple, as described above, or alternatively a thermistor or other resistance temperature detector (RTD), or other means for measuring temperature.

[0542] In some embodiments of the invention, the end of the tube 504, together with the wires 506, may be connected to a urine production measurement system 248 (FIG. 49) that measures the urine flow. The measurement system may also have circuitry to estimate the temperature sensed by the temperature sensor 505 in the connector 72. The measurement system may display the temperature and / or transmit it to the hospital's electronic medical record (EMR), patient monitor, nurse station monitor, and / or gateway. Since the measurement system knows the urine flow rate at each moment, it may sample the temperature sensor when the flow rate is above a certain rate, and therefore may ensure that the urine leaving the bladder is not cold before it reaches the sensor. If the measurement system is associated with a means to control the flow rate (as in some embodiments of the invention, for example in embodiments where the urine is pumped), when the subject's urine production is very low, the measurement system may briefly stop the flow of urine from the bladder (e.g. by stopping the pump) so that urine accumulates in the bladder, and then allow the urine to flow at a high rate and sample the temperature sensor when the warm urine from the bladder reaches the connector 72.

[0543] In another embodiment, the temperature sensor has a capillary tube that extends along the tube 504 and is connected to a pressure measurement device at the downstream end of the tube. The pressure in the capillary tube varies with temperature; therefore, the pressure measurement device may measure (or "estimate") the temperature indirectly by measuring the pressure in the capillary tube. Thus, temperature may also be measured in a non-electrical manner. This embodiment may be implemented using a dual lumen tube (e.g., as shown in FIG. 15), one lumen for urine and the other lumen for pressure changes caused by temperature changes. The pressure is then measured at the downstream end of the tube and converted to a temperature, which is displayed and / or registered on a monitor and / or other measurement or display device. Pressure-based temperature estimation may be performed, for example, using a sealed bellows or valve with a capillary element filled with a gas or liquid that expands or contracts in response to temperature.

[0544] Spring-loaded safety release for peristaltic pumps

[0545] 36A and 36B are schematic side views of a peristaltic pump 20 with a spring-loaded safety release in normal and released configurations, respectively, according to some embodiments of the present invention. Pump 20 has a pumping mechanism, such as a rotor 22 having rollers 24 that propel fluid through a flexible portion of peristaltic pump tubing 33. (Typically, but not necessarily, the entire length of pump tubing 33 is flexible.) Alternatively, the principles of this embodiment can be applied in combination with other types of pumping mechanisms and tubing configurations.

[0546] 36A and 36B show an example of a mechanism for releasing the grip of pump 20 on pump tube 33. In normal operation, roller 24 rolls and presses against a portion of pump tube 33 while clamp 26 presses a portion of the pump tube against the roller, so that the roller compresses the pump tube. However, if there is some system failure that prevents rotor 22 from rotating (e.g., pump actuator failure, software bug, or power failure), clamp 26 of pump 20 will continue to press pump tube 33 against roller 24 of rotor 22, blocking urine flow. Pump 20 therefore has a release mechanism that receives an indication of a failure in the fluid circuit to which pump tube 33 is connected and in response to that indication will release clamp 26, allowing urine to flow freely through the pump tube.

[0547] In this example, the indication of the fault includes an increase in pressure in a section 518 of the pump tubing 33 at a location upstream of the pump 20. The release mechanism has a moveable rod 516 having one end in contact with the section 518 of the pump tubing 33 such that an increase in pressure expands the tube and moves the rod, releasing the clamp 26. In normal operation, the spring 511 exerts compression against the clamp 26 such that it presses the clamp against the pump tubing 33. The release mechanism releases the compression of the spring 511 in response to the fault indication.

[0548] More specifically, rod 512 pushes against spring 511, which presses clamp 26 against pump tube 33. Rod 512 is normally held in place by rod 513, which pushes against spring 521, which is held in place by rod 516. Rod 516 is held against pump tube 33 by spring 515. Section 518 of pump tube 33 has a thinner wall than the rest of the tube. When a failure occurs, urine backup increases pressure within pump tube 33 and section 518 begins to expand, forcing rod 516 against spring 515 until rod 513 is retracted by spring 521 into notch 522. The retraction of rod 513 releases its hold on rod 512, which is pushed back by the extension of spring 511, thereby causing clamp 26 to release pressure on pump tube 33 and allowing urine to flow freely through the tube.

[0549] Additionally or alternatively, an electromechanical switch such as a solenoid 517 can be used to release clamp 26 in response to an electrical signal indicating a fault. Solenoid 517 can be actuated by software, a manual command, a power outage, or the action of a safety sensor. The plunger of solenoid 517 is out as shown in FIG. 36B unless power is applied to the solenoid as shown in FIG. 36A. During normal operation of pump 20, power is applied to solenoid 517, which pulls the plunger in. If there is a fault, power to the solenoid is removed, which causes the plunger to push rod 516, which then releases rod 512 as described above.

[0550] Pressure control using spring-loaded components in peristaltic pumps

[0551] Figure 2 shows an example of an aging graph of a peristaltic pump tube 33 (Figures 1B-C). The graph shows the change in stroke volume of a peristaltic pump as a function of the number of strokes applied to the pump tube within the pump. As can be seen from the graph, stroke volume tends to increase as the pump tube wears.

[0552] 38A and 38B are schematic side views of springs 526 and 524 used in controlling pressure applied by a clamp in a peristaltic pump (such as clamp 26 in pump 20), according to some embodiments of the present invention. Spring 526 has a spring constant k1 and spring 524 has a spring constant k2. The springs are labeled 526a and 524a, respectively, in a relaxed state (uncompressed) and 526b and 524b when compressed a distance X from a given baseline 527.

[0553] The force exerted by the springs is calculated according to Hooke's Law as F=k*X, where F is the force, k is the spring characteristic (spring constant), and X is the displacement of the edge of the spring. In order for springs 524 and 526, which have different characteristics, to exert the same force when displaced the same distance X, the weaker spring needs to be biased (pre-compressed from a relaxed state). This type of bias state of spring 526 is labeled 526c with a bias offset of D. In this case, F1=k1*(D+X), and F2=k2*X. To satisfy F1=F2, the offsets need to be chosen such that k1*(D+X)=k2*X. This condition is satisfied for k2>>k1 when D>>X.

[0554] When both springs are compressed by an additional distance ΔX from their compressed states 524b and 526b, the additional force exerted by each spring is k*ΔX. For spring 526, the additional force is k1*ΔX, and for spring 524, the additional force is k2*ΔX. Since k1 << k2, the additional force exerted by spring 526 as a result of the additional movement ΔX is much smaller than the additional force exerted by spring 524 as a result of the same additional movement ΔX. In other words, the change in force exerted by a spring with a small k when the spring is compressed by an additional amount is much smaller than the change in force of a spring with a large k compressed by the same additional amount. By using a long spring with a small k, the force exerted by the spring is kept substantially constant for small displacements of the spring.

[0555] Figures 39A, 39B, and 39C are schematic side views of a peristaltic pump 20 with a spring-loaded pressure clamp 26 according to an embodiment of the present invention. Each pump 20 has a rotor 22 having a plurality of pressing elements in the form of rollers (e.g., four rollers), which roll (roll) to press a portion of a flexible pump tube 33 through which fluid flows from a fluid source such as a urethral catheter. One or more springs 524, 526, 528 apply compression (i.e., a compressive force) between the roller 24 and the clamp 26 so that the roller applies a substantially constant force to the pump tube 33 regardless of changes in the hardness or thickness of the tube. (In the context of this embodiment and the claims, the term "substantially constant" means that the force remains within ±5% of its initial value.)

[0556] Specifically, in the embodiment shown in FIGS. 39A-C, springs 524, 526, and 528 are attached to the clamp 26. (Alternatively, in the following embodiments, the springs are coupled to the roller or the rotor.) Springs 524 and 526 are linear springs and, as described above, have high and low spring constants, respectively. Spring 528 is a coil spring, i.e., a helical torsion spring (also called a rotor spring). The advantage of this type of spring is that it can be very long with small outer dimensions.

[0557] According to some embodiments of the invention, pump tube 33 is disposable; for example, the pump tube may belong to a disposable kit 370 (FIG. 66A). Additionally, clamp 26 may be disposable. Thus, the pump is used with multiple different pump tubes and, optionally, multiple different clamps. Because there may be tolerances in the dimensions of these elements during manufacturing, the force exerted by the clamp on the pump tube may differ as the spring is pushed by different amounts due to variations in pump tube and / or clamp dimensions.

[0558] To avoid this force variation, which leads to variations in the pump's stroke volume, the spring must be selected to exert a substantially constant force over a range of displacements. For example, a long spring with a low spring constant, such as spring 526, or a helical spring, such as spring 528, each biased, i.e. significantly compressed, relative to the working displacement, can be used for this purpose. As a result, slight differences in the geometry of the clamp and pump tube do not substantially affect the force applied by the spring, since the variations in spring displacement as a result of these differences are much smaller than the bias displacement (as explained with reference to FIG. 38). Similarly, the force applied by the spring on the pump tube changes very little as the pump tube wears, thus maintaining a uniform stroke volume and extending the life of the pump tube.

[0559] The embodiments described below relate to rotary peristaltic pumps in which rollers 24 push and compress a portion of the flexible pump tube to propel fluid through the pump tube. In these embodiments, one or more springs apply compression between the pushing element, i.e. rotor 22 with rollers 24, and clamp 26, so that the pushing element applies a force against a portion of the flexible pump tube such that the force remains substantially constant regardless of changes in the mechanical properties of the pump's components, e.g. due to wear of the pump tube. Alternatively, the principles of these embodiments may be applied, mutatis mutandis, to other types of peristaltic pumps with other kinds of pushing elements. For example, these principles may be applied in improving the performance of a linear peristaltic pump, where the pushing element has linear translating elements ("fingers") that continuously push against the flexible pump tube.

[0560] 41 and 42 show schematic diagrams of a peristaltic pump rotor 22 having spring-loaded rollers 24, according to an embodiment of the present invention. FIG. 41 is a side view, and FIG. 42 is a pictorial view. In both of these embodiments, the rotor 22 has a rotating drum 530 in which the rollers 24 are mounted. Springs 535 are coupled to move the rollers radially outward within the drum 530, thus maintaining a substantially constant force between the rollers and the pump tube 33 (not shown in these figures). Specifically, the rollers 24 are mounted to respective rods 533 that pivot about respective axes 534 on the drum 530. The springs 535 are attached to the rods 533 and exert a rotational force on the rods about their respective axes.

[0561] In the illustrated example, spring 535 is stretched counterclockwise about axis 534, pushing rod 533 clockwise about the axis, thus pushing roller 24 outward relative to axis 32, at the center of rotor 22. The force exerted by spring 535 causes roller 24 to press pump tube 33 against clamp 26. Spring 535 may be designed to exert a force that increases with displacement according to Hooke's Law, or may be designed to exert a substantially constant force, as described above, to overcome manufacturing tolerances. Alternatively, the spring may have a constant force spring to adjust the force of the Hooke's Law spring to reduce sensitivity to tolerances of pump components (clamp, pump tube, rotor, etc.).

[0562] In FIG. 41, pin 536 acts as a stop to limit the movement of rod 533 when there is no pump tube in the pump and roller 24 is not pressing against the pump tube.

[0563] 42, the rollers 24 are mounted in respective radial slots 537 in drum 530. Tension applied by springs 535 urges the rollers to move radially within the radial slots, but the boundaries of the slot limit the rollers' movement.

[0564] 41 and 42, drum 530 has a diameter that is greater than the diameter of circle 538 on which rollers 24 are disposed. This difference in diameter leaves room on drum 530 for spring 535 and rod 533 to be disposed outside the radius of circle 538.

[0565] Figure 43 is a schematic side view of a peristaltic pump rotor 22 having a spring-loaded roller 24 according to yet another embodiment of the invention. This embodiment is similar to the embodiment of Figures 41 and 42, except that in this embodiment a spring 540 is attached to the roller 24. The roller 24 is attached to the end of a rod 533 as in the previous embodiment, but the spring 540 pushes directly on the roller rather than pushing on the rod. Thus, the rod 533 only serves to hold and guide the roller during movement. This arrangement is advantageous in that less force is required and therefore a smaller spring can be used.

[0566] Reference is now made to Figures 44A and 44B, which show diagrammatically a rotor 22 of a peristaltic pump having spring-loaded rollers 24 according to a further embodiment of the invention. Figure 44A is a diagrammatic detailed view of one of the rollers 24 having a spring-loaded rolling bearing 541, while Figure 44B is a diagrammatic view of the rotor 22 as a whole.

[0567] In this example, the rollers 24 have rolling bearings 541 that are connected to the ends of the rollers and slide radially in radial slots 547 in the drum 542 that limit the movement of the rollers. A spring 545 pushes the rollers radially outward. As in the previous embodiment, the spring 545 may be designed to exert a force that increases with displacement according to Hooke's law, or it may be designed to exert a substantially constant force, or it may have a constant force spring to adjust the force of the Hooke's law spring. The bearings 541 are useful for reducing friction so that the rollers roll smoothly against the pump tube, thus reducing wear on the pump tube. In this example, the diameter of the drum 542 is only slightly larger than the distance between the far ends of the two opposing rollers.

[0568] 45A and 45B are schematic and side views, respectively, of spring-loaded rollers 24 of a peristaltic pump according to yet another embodiment of the invention. As in the previous embodiment, rollers 24 are mounted for radial movement within slots 547. Springs 545 mounted on each axle 548 apply a force that drives the rollers radially outward against the flexible pump tubing. In this embodiment, drum 542 has a larger diameter than the previous embodiment to accommodate the longer springs.

[0569] 46A and 46B are schematic side views of a peristaltic pump with a replaceable (i.e., disposable) cartridge 374 before and after attachment of the cartridge to the pump, according to some embodiments of the present invention. Cartridge 374 includes pump tubing 33, clamp 26, and latch 552 for holding the cartridge in place when the cartridge is inserted into the pump. Springs 557 and 558 are coupled to urge rotor 22 toward clamp 26.

[0570] Because the cartridges 374 are replaceable and have manufacturing tolerances, the pump cannot be pre-calibrated for a particular cartridge, and therefore a mechanism is required that can tolerate these tolerances to achieve a highly accurate pumping volume. Additionally, pump components such as rotors, rollers, bearings and clamps wear during operation and this wear must be accommodated to maintain high accuracy.

[0571] In this example, rotor 22 is attached by struts 556 to spring 557 which pushes the rotor to the right. Spring 557 is pushed by constant force spring 558 via rod 553. When cartridge 374 is first inserted into the pump, rotor 22 rotates to a predefined position (e.g., the position shown in these figures). Cartridge 374 is pushed towards the left, compressing spring 557 until it reaches the force of spring 558. At this point, spring 558 begins to compress and spring 557 does not compress any further given the nearly constant force exerted by spring 558.

[0572] When cartridge 374 is fully inserted (moved to the left), latch 552 snaps into place against stopper 551. In this position, spring 557 is compressed by the constant force of spring 558, and solenoid 554 pushes plunger 559 against rod 553, holding the rod in place against stopper 560. Solenoid 554 and plunger 559 act as a lock, which opens during insertion of cartridge 374 into the pump to allow springs 557 and 558 to drive rotor 22 towards clamp 26 into a position where roller 24 exerts a desired constant force against flexible pump tube 33. Solenoid 554 and plunger 559 lock the end of spring 557 far from the rotor in this position during pump operation. When the pump starts to operate and rotor 22 rotates, spring 557 is secured by rod 553 on its left side, pushing rotor 22 against pump tube 33 against clamp 26 on its right side.

[0573] This mechanism reduces the sensitivity of the pump to dimensional tolerances of the cartridge 374 because upon insertion of the cartridge, the spring 557 is compressed with a force of the spring 558 that is substantially constant, rather than a force that is a function of the thickness of the clamp 26 or pump tubing, as would be the case if the spring 557 were simply fixed to the body of the pump. In an alternative embodiment, a similar spring arrangement could be used to push the cartridge towards the rotor while the rotor is held in a fixed position. In yet another embodiment, the cartridge and rotor are fixed and the rollers of the rotor are pushed by this type of combination of a locking spring.

[0574] In all these embodiments, when the cartridge is inserted into the pump, the rotor or cartridge or roller is brought to a known predefined position. The constant force spring 558 serves to compensate for any tolerances in the dimensions of the cartridge components and clamps while the cartridge is inserted, so that the spring 557 exerts the same force regardless of the cartridge dimensions. Once the cartridge is inserted, the solenoid 554 locks the position of the spring 557 in place. Thus, the spring 557 causes the roller 24 and clamp 26 to exert the same force on the pump tube 33 regardless of dimensional changes in the dimensions of the clamp and cartridge components. Because the spring 557 operates according to Hooke's Law, this arrangement ensures that the initial force on the pump tube 33 is fixed regardless of mechanical tolerances, but will change, for example, as the pump tube wears.

[0575] In another embodiment, spring 557 and solenoid 554 are omitted and only spring 558 exerts a force on rotor 22 or clamp 26. With this arrangement, the force exerted on pump tube 33 is still constant regardless of mechanical tolerances and wear.

[0576] Fluid bag suspension scale

[0577] Reference is now made to Figs. 47A-D, which show generally a hanging scale 561 for a fluid bag for receiving fluid excreted from a subject's body, such as a urine collection bag 78, according to some embodiments of the present invention. Fig. 47A shows a side view of the hanging scale 561 and bag 78, and Fig. 47B shows a detailed view of the scale 561. Fig. 47C shows a detailed view of a controller 564 integrated into the hanging scale 561, and Fig. 47D shows a block diagram schematic of circuitry 566 within the controller 564. The scale 561 has a hanger 562 having a hook 563 from which the urine collection bag 78 is hung. The hanger 562 has a hook for hanging or otherwise attaching the hanging scale 561 to a support such as an IV pole, the subject's bed, an infusion pump, a urine production measurement system 248 (Fig. 49), or a wall. A sensor 572 senses the amount of fluid in the bag 78, which indicates the amount of fluid excreted by the subject.

[0578] 47A-D can be used to suspend and measure the amount of fluid in other types of fluid bags, such as intravenous infusion bags, in which case the sensor 572 is used to sense the amount of fluid being delivered to the subject.

[0579] The hanging balance 561 includes a controller 564 having an electronic circuit 566 that includes a sensor 572 for detecting the fill level of the bag. In some embodiments, the sensor 572 measures the weight of the fluid in the bag 78. For this purpose, the sensor 572 may have, for example, a strain gauge, a load cell, or a spring combined with a detector such as a potentiometer, a photodetector, a variable capacitor, or a variable inductor. Additionally or alternatively, the sensor 572 measures the level of the fluid in the bag 78, for example, using an ultrasonic or photodetector to detect the liquid surface level. As another option, the sensor 572 may detect the expansion and contraction of the bag 78 to determine the amount of fluid in the bag. This approach is advantageous in that it is not affected by tube distortions that may affect the weight of the bag itself and the weight measurement. The controller 564 may measure the amount of fluid in the bag 78 using any of the above methods individually or in combination, as well as other methods that will be apparent to those of skill in the art after reading this description.

[0580] The controller 564 issues an alarm when the amount of fluid in the bag 78 reaches a predefined limit (e.g., when the bag 78 is nearly full or, in some cases, nearly empty). To this end, the controller 564 may include an audible alarm 567 and / or a light 568. The functions of the controller 564 are coordinated by a processor 573 with a memory 574. A battery 577, which may be rechargeable or non-rechargeable, powers these and other elements of the circuit 566. Alternatively or additionally, the circuit 566 may receive power from an electrical outlet. The processor 573 handles functions such as communications, control of calibration and zeroing of the sensor 572, receiving readings from the sensor, calculating and determining if the amount of fluid in the bag has reached a threshold, and activation of the audible and visual alarms. The memory 574 stores, for example, program code, data, configuration data, and historical data.

[0581] In the illustrated embodiment, the controller 564 has a communication link, such as a wireless transmitter or transceiver 569 or a wired link 570, to communicate an indication of the sensed amount of fluid to a receiver. The wireless transmitter or transceiver may operate according to any suitable standard or proprietary protocol, such as, for example, Wi-Fi, Bluetooth, Zigbee, or NFC. The communication link may be used to send an alarm message when the amount of fluid in the bag 78 reaches a predefined limit. The communication link may also be used to configure the controller 564, such as by setting alarm settings and threshold levels. Several threshold levels may be set, with each threshold triggering an alarm of a different severity level. Other configurable parameters may include, for example, the volume, audio type, and visual type (such as blink rate and intensity) of the alarm.

[0582] The communications link may also be used to transmit historical data, either on demand or periodically. Such historical data may include, for example, the number of bags replaced, the time each bag was replaced, the time from alarm to bag replacement, and the fill level when the bag was replaced. Additionally or alternatively, the communications link may be used to warn that the battery 577 is low and needs to be recharged or replaced.

[0583] Data is transmitted from the hanging scale 561 to a receiver such as a gateway, which may also communicate with other hanging scales of this type. Data may be communicated via the gateway or directly from the hanging scale to a monitoring system (including, for example, a patient monitor and / or a nurse's station monitor) and / or an EMR. Alternatively or additionally, data may be transmitted to the urine production measurement system 248 (FIG. 49) to indicate to the system 248 that the fill level of the bag and / or the fill level has reached a threshold. In any of these cases, the gateway, monitoring system or measurement system may receive an indication from the hanging scale 561 that the sensed amount and / or fill level of fluid in the bag 78 has reached a threshold, and may therefore calculate and display information regarding the subject's output of urine over time and / or warn that the bag is nearly full. Alternatively, if the hanging scale is used to hang an infusion bag, the controller 564 may send a signal to the infusion pump, the gateway, the monitoring system and / or the EMR indicating the fill level of the bag and / or that the bag has emptied to a predetermined threshold. Thus, the infusion pump, gateway, monitoring system, and / or EMR can calculate and display information regarding fluid administration to a subject over time.

[0584] The monitoring system may receive data from the hanging balance 561 via either a wired or wireless link. The monitoring system may have means for alerting medical staff by visual and / or audio alarms such as a speaker, buzzer and / or lamp. The monitoring system may also have means for inputting data such as a keyboard to set configuration parameters of the hanging balance 561 such as alarm thresholds. The monitoring system may have means for outputting data such as a display to show historical data such as the number of bags exchanged, the total amount of bags filled (e.g., in the case of intravenous infusion) or emptied (e.g., in the case of urinary output), and real-time information such as bag fluid levels. Thus, the monitoring system can display information regarding both the output of fluid by the subject and the input of fluid into the subject's body over time. These types of data can be displayed simultaneously for multiple subjects.

[0585] The weight of the fluid measured by the hanging balance 561 may not be stable for a number of reasons, including shaking of the bag 78 and distortion of the bag or the tubing connected to the bag. This instability is referred to herein as "noise."

[0586] In some embodiments, the device receiving the indication of fluid volume from the hanging scale may filter out noise (e.g., as described with reference to FIG. 49) to estimate the actual weight. Alternatively, the processor 573 of the hanging scale circuit 566 may filter out the noise. The monitoring system, urine production measurement system, or infusion pump may display the current weight of the bag and / or the current flow rate (i.e., how full or empty the bag is) in real time and may provide warnings if the flow rate is above or below a predetermined limit and / or if the bag fill level reaches a threshold.

[0587] 48 is a schematic diagram of a display screen illustrating a fluid management dashboard 580 according to some embodiments of the present invention. The dashboard 580 is displayed by a receiving device, such as a monitoring system, and presents information regarding a number of bags (including both infusion bags and urine collection bags) connected to each of a number of subjects.

[0588] In this example, dashboard 580 presents information about eight bags connected to three different subjects. Blocks 581, 582, and 583 display information about three bags for subject 1. Blocks 584 and 585 display information about two bags for subject 2. Blocks 586, 587, and 588 display information about three bags for subject 3. Block 581 displays information about an IV saline bag connected to subject 1 and hanging on a hanging scale (as shown in FIGS. 47A-D) near subject 1. According to block 581, a fourth bag was replaced at 7:38 PM and is 60% full. Block 582 displays information about an enteral feeding bag connected to subject 1 and hanging on another hanging scale near subject 1. The first enteral feeding bag was started at 8:00 PM and is 10% full with a warning that the bag is almost empty. Block 583 displays information about the urine bag connected to subject 1 and hanging on a separate hanging scale near subject 1. Block 583 displays the hourly urine output for the past four hours. This list can be scrolled to display more historical data.

[0589] For subject 2, block 584 displays information about the IV saline bags connected to and hanging from a hanging scale near subject 2. According to block 584, the 12th bag was changed at 1:22 PM and is 25% full. Block 585 displays information about the urine bag connected to and hanging from a hanging scale near subject 2. The information displayed includes hourly urine output for the past four hours, and the list can be scrolled to view more historical data.

[0590] For subject 3, block 586 displays information about the IV blood bag connected to subject 3 and hanging from a hanging scale near subject 3. Block 586 shows that the first bag was started at 4:00 PM and is 20% full. Block 587 displays information about the IV saline bag connected to subject 3 and hanging from a hanging scale near subject 3. Block 587 shows that the second bag was changed at 7:00 AM and is empty and displays an alarm to change the empty bag. Block 588 displays information about the urine bag connected to subject 3 and hanging from a hanging scale near subject 3. The information displayed includes hourly urine output for the past four hours and the list can be scrolled to view more historical data.

[0591] Tapping on each of the above blocks will open a window for additional information or configuration. Using the configuration control 589, you can set parameters such as: · Type of bag (urine, saline, blood, etc.). · An empty or full threshold level at which a visual alarm or warning is indicated. Empty or full level with audio alarm or warning. The percentage of fill or empty above or below which a visual alarm or warning will be displayed. Percentage of fill or empty above or below which an audible alarm or warning will sound. · Enable or disable visual or audible alarms. Set the alarm volume, audio type, and visual type.

[0592] Additional information that may be displayed may include historical data such as the time each bag was changed and the time from alarm to bag change. Other information may include the remaining battery charge.

[0593] It will be appreciated by those skilled in the art that the present invention is not limited to what has been particularly shown and described above, but rather, the scope of the present invention includes both combinations and subcombinations of the various features described above, as well as modifications and variations thereof that are not in the prior art and which will occur to those skilled in the art upon reading the above description.

Claims

1. 1. An apparatus for use with a conduit configured to carry urine downstream from a subject's bladder, the apparatus comprising: One or more force applying elements: reversibly binds to the conduit; applying a force to the conduit when coupled to the conduit; one or more force applying elements configured to A controller: controlling the force application element such that the force application element applies a force to the conduit to urge the urine in a downstream direction out of the conduit; calculating the volume of the urine displaced based on control of the force applying element; a controller configured to An apparatus having the above configuration.

2. The conduit further comprises:

2. The apparatus of claim 1.

3. the force application element comprises an actuator configured to reversibly couple to the conduit and apply the force to the conduit via a fluid in a fluid-filled tube.

2. The apparatus of claim 1.

4. a pressure sensor coupled to the fluid filled tube for sensing a fluid pressure of the fluid; transmitting a signal indicative of the fluid pressure to the controller; The pressure sensor further includes a pressure sensor configured as follows: the controller is configured to control the force application element in response to the signal.

4. The apparatus of claim 3.

5. the conduit includes a chamber including a movable wall, the force applying element being configured to apply the force to the movable wall.

2. The apparatus of claim 1.

6. and a case coupled to the force application element, the force application element being configured to reversibly couple to the conduit by the case reversibly coupling to the conduit.

6. Apparatus according to any one of claims 1 to 5.

7. the conduit is at least partially contained within a cartridge, the case being formed to define a slot, the case being configured to reversibly couple to the conduit via insertion of the cartridge into the slot.

7. The apparatus of claim 6.

8. the conduit is coupled to one or more latches, and the case is configured to reversibly couple to the conduit by the latches latching to the case.

7. The apparatus of claim 6.

9. the case includes one or more latches configured to latch to a housing of the conduit, thereby reversibly coupling the case to the conduit; 7. The apparatus of claim 6.

10. The case is: an electrical interface connected to the controller and configured to couple to the cable such that the controller is powered via the cable; and a communications interface connected to the controller and configured to couple to the cable; having the controller is configured to communicate the calculated quantity, or a parameter derived therefrom, via the communication interface and the cable; 7. The apparatus of claim 6.

11. The force application element comprises: A pressing element; and an actuator configured to press the pushing element against the conduit to apply the force to the conduit; The controller is configured to control the actuator.

6. An apparatus according to claim 1, 2 or 5.

12. The conduit includes a tube, and the pushing element is configured to push against the tube.

12. The apparatus of claim 11.

13. The pressing element has a rotor configured to rotate while pressing against the tube.

13. The apparatus of claim 12.

14. the actuator is further configured to measure a reciprocal force exerted by the conduit on the pushing element, and the controller is configured to control the actuator in response to the reciprocal force.

12. The apparatus of claim 11.

15. The actuator has an encoder configured to detect a position of the pressing element, and the controller is configured to control the actuator in response to the position.

12. The apparatus of claim 11.

16. a sensor configured to transmit a signal to the controller that varies in response to an amount of urine in the conduit or the bladder, the controller being configured to control the force application element in response to the signal.

6. Apparatus according to any one of claims 1 to 3 and 5.

17. the sensor includes a pressure sensor configured to couple to the conduit to sense a pressure within the conduit, the signal being indicative of the pressure.

17. The apparatus of claim 16.

18. the conduit includes an expandable portion configured to expand as the urine flows into the expandable portion; the sensor is configured to sense a degree of expansion of the expandable portion; the signal being indicative of the extent of the expansion.

17. The apparatus of claim 16.

19. the expandable portion includes a reservoir disposed upstream from the portion of the conduit where the force is applied.

20. The apparatus of claim 18.

20. the expandable portion includes a movable wall and is configured to expand via movement of the movable wall, and the force applying element is configured to apply the force to the movable wall.

20. The apparatus of claim 18.

21. the sensor includes a pressure sensor configured to sense a pressure that varies in response to the degree of expansion; 20. The apparatus of claim 18.

22. the sensor includes an optical sensor configured to sense the extent of the expansion by emitting light at the expandable portion; 20. The apparatus of claim 18.

23. the conduit is coupled to a first electrical interface configured to connect to the sensor, and the force application element is coupled to a second electrical interface connected to the controller, and when the force application element is coupled to the conduit, the sensor is configured to contact the first electrical interface to communicate the signal to the controller via the first electrical interface and the second electrical interface.

17. The apparatus of claim 16.

24. a pressure transmission tube coupled to the conduit and configured to contain the fluid such that a fluid pressure of the fluid varies with an internal pressure within the conduit; the sensor comprises a pressure sensor configured to couple to the pressure transmission tube to sense the fluid pressure.

17. The apparatus of claim 16.

25. an optical sensor configured to sense a visual parameter of the urine and to communicate a signal indicative of the visual parameter to the controller; 6. Apparatus according to any one of claims 1 to 5.

26. 1. An apparatus for use with one or more force application elements, the apparatus comprising: at least one tube configured to carry urine flowing downstream from the subject's bladder through a urinary catheter that catheterizes the subject; and a conduit section coupled to the tube in fluid communication with the tube and configured to be reversibly coupled to the force application element to facilitate a force application element to the conduit section, thereby urging the urine in a downstream direction out of the conduit section; having Device.

27. The at least one tube comprises an upstream tube connected to an upstream end of the conduit section, the apparatus further comprising: a bypass tube connected to the upstream tube; and A valve comprising: preventing flow of the urine through the bypass tube when pressure in the bypass tube is below a predetermined threshold; allowing the flow of the urine to bypass the conduit section when the pressure exceeds the threshold. a valve configured to 27. The apparatus of claim 26.

28. the at least one tube further comprises a downstream tube connected to a downstream end of the conduit section; The device further comprises a connector configured to connect the downstream tube to a urine collection bag; the bypass tube is connected to the connector such that the bypass tube passes between the upstream tube and the connector; 28. The apparatus of claim 27.

29. The valve is integrated into the connector.

30. The apparatus of claim 28.

30. the force application element is coupled to a case, and the conduit section is configured to reversibly couple to the force application element by reversibly coupling to the case.

30. Apparatus according to any one of claims 26 to 29.

31. further comprising a cartridge housing the conduit section.

31. The apparatus of claim 30.

32. the case is formed to define a slot; the conduit section is configured to reversibly couple to the case via insertion of a cartridge into the slot; 32. The apparatus of claim 31.

33. and further comprising one or more latches coupled to the conduit section and configured to latch to the case, thereby reversibly coupling the conduit section to the case.

31. The apparatus of claim 30.

34. a housing for receiving the conduit section; the case includes one or more latches configured to latch to the housing; the conduit section is configured to reversibly couple to the case by the latch latching to the housing; 31. The apparatus of claim 30.

35. the force application element comprises a pressing element configured to apply the force to the conduit section by pressing against the conduit section; 30. Apparatus according to any one of claims 26 to 29.

36. the conduit section comprises a peristaltic pump tube, the conduit section being configured to reversibly couple to a pushing element to facilitate the pushing element pushing against the peristaltic pump tube; 36. The apparatus of claim 35.

37. the conduit section has a chamber including a movable wall, the conduit section configured to reversibly couple to the force application element to facilitate the force application element applying the force to the movable wall; 30. Apparatus according to any one of claims 26 to 29.

38. a reservoir disposed upstream from the conduit section.

30. Apparatus according to any one of claims 26 to 29.

39. the reservoir is configured to expand as the urine flows into the reservoir; 39. The apparatus of claim 38.

40. a sensor configured to deliver a signal that varies in response to the amount of urine in the reservoir; 39. The apparatus of claim 38.

41. a sensor configured to deliver a signal that varies in response to the amount of urine in the conduit section; 30. Apparatus according to any one of claims 26 to 29.

42. a pressure sensor configured to sense an outlet pressure at the outlet of the urinary catheter and to communicate a signal indicative of the outlet pressure.

30. Apparatus according to any one of claims 26 to 29.

43. a connection port coupled to the tube or conduit section and configured to couple to a pressure sensor such that the pressure sensor senses an internal pressure within the tube or conduit section; 30. Apparatus according to any one of claims 26 to 29.

44. a connection port coupled to the tube or conduit section and configured to couple to the pressure transmission tube containing a fluid such that the fluid pressure in the pressure transmission tube varies in response to the internal pressure in the tube or conduit section.

30. Apparatus according to any one of claims 26 to 29.

45. The pressure transmission tube is further included.

45. The apparatus of claim 44.

46. a first electrical interface coupled to the conduit section and configured to connect to a sensor, the force application element being coupled to a second electrical interface connected to the controller and configured to contact the first electrical interface such that when the conduit section is coupled to the force application element, the sensor communicates a signal to the controller via the first electrical interface and the second electrical interface.

30. Apparatus according to any one of claims 26 to 29.

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