Bladder drainage and irrigation pump

Abstract

A bladder drainage and irrigation pump system includes a pump subsystem, a housing subsystem, an electrical subsystem, and a user interface subsystem. The pump, which may be a peristaltic pump, actuates fluid through a length of flexible tubing in a direction away from a catheter in fluid communication with a catheter-end port, toward a drainage outlet port. A controller of the system terminates a drainage cycle once a pressure sensor detects a change in pressure indicative of the bladder being substantially empty. An irrigation cycle is then initiated during which the direction of the pump is reversed and irrigation fluid is delivered via the catheter to the bladder. The pump then drains the used irrigant out of the bladder. An intuitive user interface is used to separately initiate drainage and irrigation cycles.

Description

BLADDER DRAINAGE AND IRRIGATION PUMPFIELD

[0001] This disclosure relates generally to systems and methods for managing urinary drainage, and more specifically, to a portable and intuitive bladder drainage and irrigation pump to facilitate effective drainage of urine the bladder, introduction of irrigation fluid into the bladder, and drainage of irrigation fluid from the bladder, particularly for patients who require clean intermittent catheterization through an abdominal stoma.BACKGROUND

[0002] Many neurogenic bladder patients depend on clean intermittent catheterization (CIC) through an abdominal stoma to drain their bladder of urine. The typical CIC drainage process is time consuming for both patients and caretakers, with a typical catheter drainage of the bladder taking approximately 20 minutes or more. With neurogenic bladder patients needing to drain their bladder four-to-six times per day, and at least one or two of those bladder drainage procedures requiring irrigation of the bladder involving connection of syringe to the catheter, insertion of saline from the syringe through the catheter, and drainage of the saline and any additional urine, attending to the urostomate’s bladder drainage and irrigation needs can easily take upwards of an hour-and-a-half per day.

[0003] Due to the slow process, urostomates and caregivers may fail to drain the bladder completely, leaving urine and / or saline in the bladder for long periods of time. This can lead to further health complications for the urostomate, including urinary tract infections, ureter obstruction, renal failure, kidney stones, and the like.

[0004] While there have been various attempts to develop solutions for neurogenic patients, such as sacral neuromodulation, which involves the use of electrical pulses to correct bladder function via an invasive device, such approaches do not permit irrigation of the bladder, do not function cooperatively with an abdominal stoma, and are not cleanable. Some of these attempts do not actively drain the bladder.

[0005] There is a need for a bladder drainage and irrigation system for neurogenic bladder patients using CIC that provides an accessible, time-efficient, and portable solution to sufficiently drain and irrigate the bladder in a manner that maintains safe pressure, flow, and urine volume levels while reducing risks of infection and other complications.

[0006] In order to provide an effective flow rate that is atraumatic to the patient’s bladder wall and surrounding anatomy, a bladder drainage and irrigation device should have a flow rate of at least 2.04 mL / s and no greater than 50 mL / s, for viscosities in a range of 0.68-1 .07 cSt, and any created pressures should be in a range of -203.9 cm H2O and 40 cm H2O. Itwould be desirable if a device could be provided to effectively drain the bladder at least twice as fast as conventional CIC, without adverse effects. Following bladder drainage, the residual volume of urine in the bladder should be at most about 2.53% of the bladder’s capacity. An effective volume of saline to achieve suitable irrigation after drainage of urine from the bladder would be between 60-120 mL.SUMMARY

[0007] To address the various shortcomings of conventional CIC bladder drainage and irrigation techniques, a system has been developed that significantly decreases the time and effort required, as compared to manual urinary bladder drainage and irrigation. This system features a portable pump with easy-to-use controls. The system has a principle of operation that accommodates use of a rechargeable power source, such as a rechargeable battery, and achieves reliable performance independently of the level of charge of that power source.

[0008] The system is best understood with reference to each of its four subsystems, which include a pump subsystem, an electrical subsystem, a housing subsystem, and a user interface subsystem. These subsystems cooperate with one another to various degrees to achieve optimal system functionality, capabilities, and performance.

[0009] The pump subsystem features a peristaltic pump that engages, via a plurality of roller elements, the outer wall of a length of flexible tubing that passes through the peristaltic pump, in such a manner as to advance fluid through the tubing without requiring direct fluid communication of the pumping mechanism and fluid traveling through the tubing. The interior conduit of the tubing is in fluid communication with a pressure sensor. A tee connector, a luer-lock, and medical grade thermoplastic tubing are used to interface with a conventional catheter, and facilitate sensing by the pressure sensor of pressure of fluid in the tubing, which is the pressure at the distal tip of the catheter. While this is not actual pressure on the bladder wall of the patient, the pressure at the tip of the catheter is a suitable proxy, as the primary purpose of determining pressure is to avoid applying negative pressure to the interior of the bladder once a sufficient volume of urine has been drained therefrom.

[0010] A significant change in pressure detected by the pressure sensor is presumably indicative of the tip of the catheter no longer receiving urine from the bladder, but rather, the tip of the catheter directly contacting the bladder wall. Since this condition would be indicative of the bladder being sufficiently drained of urine to discontinue pumping, the system is operable such that the controller of the electrical subsystem, upon detection of such a significant pressure change, promptly causes the pump to discontinue operation.

[0011] As the system of the present disclosure is intended for use not only in facilitating drainage of urine from the bladder, but also, introduction of irrigation fluid, namely saline, to the bladder once drained of urine, as well as the subsequent drainage of the irrigation fluid from the bladder, it is desirable for the peristaltic pump to be employed as a pumping mechanism that is effectively bi-directional, in that it can pump fluid both out of and into the bladder. The flexible tubing of the pump subsystem is preferably circuited in such a manner as to enable the peristaltic pump to engage a single length of the flexible tubing and actuate fluid in either direction, namely urine being drained may be advanced through the flexible tubing in a direction away from the bladder and toward a waste receptacle in fluid communication with the length of flexible tubing engaged by the peristaltic pump. Additionally, irrigant may be pumped in a direction from an irrigation fluid supply receptacle toward the bladder, via the same flexible tubing engaged by the peristaltic pump.

[0012] In order to place the single length of flexible tubing engaged by the peristaltic pump in fluid communication with both a waste outlet and an irrigation inlet without contaminating irrigation fluid in the irrigation fluid supply receptacle with urine being drained from the bladder, the pump subsystem of the system of the present disclosure is provided with a bifurcation block. The bifurcation block has a first tubing connector facing a direction toward the peristaltic pump, and on an opposite side, a pair of additional tubing connectors, one serving as a drainage outlet port, for carrying waste or drainage out of the bifurcation block (which receives a length of drainage tubing that carries drainage fluid out of the housing and into a waste collection receptacle), and the other serving as an irrigant inlet port.

[0013] An outlet duckbill valve is provided in fluid communication with the waste outlet port, which ensures one-way flow of fluid from the bifurcation block out the waste outlet port and prevents flow of fluid from the waste outlet port into the bifurcation block. An inlet duckbill valve is provided in fluid communication with the irrigant inlet port, which ensures one-way flow of fluid from the irrigant inlet port into the bifurcation block and prevents flow of fluid from the bifurcation block out through the irrigant inlet port.

[0014] The peristaltic pump is preferably provided with an encoder that outputs data indicative of a rotational speed of operation of the peristaltic pump. This encoder is in electronic communication with the controller, and the controller is in further electronic communication with a drive motor of the peristaltic pump.

[0015] A user interface subsystem preferably includes minimal, intuitive control mechanisms that require little dexterity to operate. For instance, the user interface subsystem may include a pair of depressible buttons, such as may be found on arcade gaming machines, which buttons may selectively illuminate. The user interface subsystempreferably further includes a warning light that is easily visible, which warning light can be illuminated upon an attempt to operate the system in a contraindicated manner, or the system operating in a manner indicative of a condition that may warrant human intervention.

[0016] A housing subsystem may include a bottom or base plate, a rear wall, sidewalls, a top wall, and a removable front lid. A partition may also be provided to help physically isolate the region of the system in which pumping operations are performed from sensitive components of the electrical subsystem and user interface subsystem. The partition may be provided with mounting structure projecting therefrom to secure the bifurcation block of the pump subsystem. The bifurcation block may be secured to the mounting structure by mating ribs and grooves, such as a pair of ribs on each of a top wall and a bottom wall of the bifurcation block that are received in a complementary pair of grooves in each of an upper wall and a lower wall of the mounting structure projecting from the partition.

[0017] The removable front lid is preferably transparent or translucent. The removable front lid may provide a passthrough for respective lengths of tubing to connect to the waste outlet port and the irrigant inlet port associated with the bifurcation block without having to remove the front lid. Another passthrough may be provide in the removable front lid to permit connection of a conventional catheter to a catheter-side port. The housing subsystem is further preferably provided with one or more handles, which may be in the form of rigid handles that are integral with the rest of the housing subsystem. Fluid-tight seals or gaskets, such as silicone seals, may also be provided intermediate the front lid and the partition, to further protect against any potential fluid contamination of sensitive components of the electrical subsystem and user interface subsystem. The housing subsystem may additionally be provided with a grip strip on one or more sides thereof, as well as stabilizing pads on a bottom of the base plate, such as silicone pads.BRIEF DESCRIPTION OF THE DRAWINGS

[0018] FIG. 1 is a front perspective view of a bladder drainage and irrigation pump system of the present disclosure;

[0019] FIG. 2 is a front elevation view of the bladder drainage and irrigation pump system of FIG. 1 ;

[0020] FIG. 3 is a front, right perspective view of the bladder drainage and irrigation pump system of FIG. 1 ;

[0021] FIG. 4 is a front, left perspective view of the bladder drainage and irrigation pump system of FIG. 1 , with a front lid removed;

[0022] FIG. 5a is a left, rear, top perspective view of the bladder drainage and irrigation pump system of FIG. 1 , with the front lid, top wall, sidewalls, and base plate of the housing subsystem removed;

[0023] FIG. 5b is a rear, top perspective view of the bladder drainage and irrigation pump system of FIG. 1 , with the front lid, top wall, sidewalls, and base plate of the housing subsystem removed, illustrating components of an electric subsystem and of a user interface subsystem;

[0024] FIG. 6 is a front, right perspective view of the bladder drainage and irrigation pump system as illustrated in FIG. 5a;

[0025] FIG. 7 is a front, right, top perspective view of a partition of the housing with a peristaltic pump unit, a bifurcation block, and tubing of the bladder drainage and irrigation pump system of the present disclosure;

[0026] FIG. 8 is a rear view of the bladder drainage and irrigation pump system as illustrated in FIG. 4;

[0027] FIG. 9 is a schematic diagram illustrating the interaction of various components of the bladder drainage and irrigation pump system of the present disclosure;

[0028] FIG. 10a illustrates the bladder drainage and irrigation pump system of the present disclosure in use;

[0029] FIG. 10b illustrates the bladder drainage and irrigation pump system of the present disclosure in use, with a simplified anatomical representation that includes the urinary tract region of a urostomate;

[0030] FIG. 11a illustrates the bladder drainage and irrigation pump system of the present disclosure in use during a bladder drainage cycle;

[0031] FIG. 11b is a flow chart summarizing user operation of the bladder drainage and irrigation pump system in preparation for, and during, the bladder drainage cycle of FIG. 11a;

[0032] FIG. 12a illustrates the bladder drainage and irrigation pump system of the present disclosure in use during a bladder drainage and irrigation cycle;

[0033] FIG. 12b is a flow chart summarizing user operation of the bladder drainage and irrigation pump system in preparation for, and during, the bladder drainage and irrigation cycle of FIG. 12a;

[0034] FIG. 13 is a left, top, and rear perspective view of the bladder drainage and irrigation pump system of the present disclosure;

[0035] FIG. 14 is an exploded view of a bifurcation block of the pump subassembly and partition of the housing subassembly of the bladder drainage and irrigation pump system of the present disclosure;

[0036] FIG. 15 is a perspective view of the bifurcation block of the pump subassembly;

[0037] FIG. 16 is a cross-sectional view taken along lines 16, 21 -16, 21 of FIG. 15, but without an irrigant inlet duckbill valve and without a drainage outlet duckbill valve;

[0038] FIG. 17 is a right, top perspective view of a duckbill valve oriented such that, when incorporated in the bifurcation block of FIGs. 15 and 16, the narrow exit-only slit of the duckbill valve face in a direction toward an interior of the bifurcation block, operable in connection with an irrigant inlet port of the bifurcation block, the duckbill valve of FIG. 17 serving as an irrigant inlet duckbill valve;

[0039] FIG. 18 is a left, top perspective view of the irrigant inlet duckbill valve of FIG. 17;

[0040] FIG. 19 is a right, top perspective view of a duckbill valve oriented such that, when incorporated in the bifurcation block of FIGs. 15 and 16, the narrow exit-only slit of the duckbill valve face in a direction away from an interior of the bifurcation block, operable in connection with a drainage outlet port of the bifurcation block, the duckbill valve of FIG. 19 serving as a drainage outlet duckbill valve;

[0041] FIG. 20 is a left, top perspective view of the drainage outlet duckbill valve of FIG. 19;

[0042] FIG. 21 is a cross-sectional view of the bifurcation block of FIG. 15, taken along lines 16, 21-16, 21 of FIG. 15, with both an irrigant inlet duckbill valve and a drainage outlet duckbill valve; and

[0043] FIG. 22 is an exploded view of the housing subassembly of the bladder drainage and irrigation pump system of the present disclosure.DETAILED DESCRIPTION

[0044] The bladder drainage and irrigation pump system of the present disclosure, generally denoted at 10, includes a pump subsystem, an electrical subsystem, a housing subsystem, and a user interface subsystem. The pump subsystem of the bladder drainage and irrigation pump system 10 preferably includes a peristaltic pump 12. The peristaltic pump 12 does not require direct fluid communication with liquids traveling through flexible tubing, such as urine being drained from the bladder, fresh irrigant fluid, such as saline, being delivered to the bladder, or used irrigant being drained from the bladder, thereby reducing the frequency of cleaning or maintenance of the bladder drainage and irrigationpump system 10. Instead of direct fluid communication, a peristaltic pump 12, such as the 15KS DC Gear Peristaltic Pump with Encoder, available from BOXER GmbH, Ottobeuren, Germany, includes a plurality of spinning rollers that selectively engage a length of flexible tubing 14 that passes through the peristaltic pump 12. Avoiding direct exposure of the components of the pump 12 to liquids increases the longevity and reliability of the peristaltic pump 12 as compared to pumps that require direct liquid exposure.

[0045] A pressure sensor 16, such as an absolute pressure transmitter for development boards (McMaster-Carr Product No. 7412N11), is in fluid communication with the flexible tubing 14 that passes through the peristaltic pump 12. The pressure sensor 16 communicates with fluid in the flexible tubing 14 via a tee connector 18, which is in further fluid communication with a catheter-side port 20. The catheter-side port 20 passes through a side of a removable front lid 30, such as through a rearwardly-open slot 32 provided in the side of the removable front lid 30. The removable front lid 30 is preferably transparent or translucent, and may be made, for example, of a clear SLA resin. The removable front lid 30 to a partition 34 may be secured, via a press fit, to a partition 34 separating the pump subsystem from the electrical subsystem and the user interface subsystem, by pushing a perimeter of an open rear end of the removable front lid onto a forwardly-projecting lip 36 that extends from a front side of the partition 34. The partition 34 serves to isolate the sensitive components of the electrical subsystem and the user interface subsystem from potential exposure to liquids traveling through the pump subsystem, whether during bladder drainage, irrigation, irrigant drainage, or cleaning of the device.

[0046] The catheter-side port 20 is configured to sealingly connect, directly or indirectly, to a conventional catheter 40 that leads through a patient’s stoma S and into the bladder B, as illustrated in FIG. 10b. The catheter-side port 20 of the bladder drainage and irrigation pump system 10 is compatible with a wide variety of gages of catheter, such as 6 to 16 French (FR), (2 to 5.3 mm diameter).

[0047] A drainage outlet port 42 and an irrigant inlet port 44 are provided in a manner that pass through a slot on an opposite side of the removable front lid 30 from the slot 32 through which the catheter-side port 20 passes. Prior to commencement of operation of the system 10 to drain the bladder B, a length of drainage tubing 46 is connected to the drainage outlet port 42, and sometime prior to commencement of operation of the system 10 to irrigate the bladder B, a length of irrigation tubing 48 is connected to the irrigant inlet port 44. The drainage tubing 46 is placed such that it opens to a drainage receptacle 50, which can be a collection container or, if not necessary to retain drained urine or other fluid, could open directly into a toilet. The irrigation tubing 48 is placed in an irrigant fluid receptacle 52, which contains a known volume of sterile irrigant fluid, such as saline.

[0048] The drainage outlet port 42 and the irrigant inlet port 44 are both in fluid communication with the flexible tubing 14 that passes through the peristaltic pump 12. However, it is undesirable to have urine or used irrigant pass through the irrigant inlet port 44 and potentially contaminate sterile irrigant in the irrigation fluid receptacle 52. To address this, the pump subsystem of the bladder drainage and irrigation pump system 10 is provided with a bifurcation block 54. The bifurcation block 54, as best illustrated in FIGs. 15, 16, and 21 , includes a first tubing connector 56 disposed in a direction toward the peristaltic pump 12. An interior end of the first tubing connector 56 opens to a bifurcation block chamber 58 on an interior of the bifurcation block 54. On a side of the bifurcation block 54 opposite the first tubing connector 56, also in fluid communication with the bifurcation block chamber 58, are the drainage outlet port 42 (for carrying waste or drainage out of the bifurcation block) and the irrigant inlet port 44 (for accepting irrigation fluid into the bifurcation block 54).

[0049] As illustrated in FIG. 16, bifurcation block 54 includes a first annular recess 60 intermediate the drainage outlet port 42 and the bifurcation block chamber 58. A second annular recess 62 is provided in the bifurcation block 54 intermediate the irrigant inlet port 44 and the bifurcation block chamber 58. The bifurcation block 54 receives a pair of duckbill valves 64, 66 in these respective first and second annular recesses 60, 62. The duckbill valve 64 is a drainage outlet duckbill valve, and is oriented with its narrow slit pointed in a direction facing an exit of the drainage outlet port 42. The duckbill valve 66 is an irrigant inlet duckbill valve and is oriented with its narrow slit pointing in a direction toward the interior of the bifurcation block chamber 58. Because the narrow slits of the first and second duckbill valves 64, 66 restrict the direction of flow through the duckbill valves to a direction toward the narrow slit, the bifurcation block 54 is able to maintain fluid communication between the first tubing connector 56 and the bifurcation block chamber 58 while selectively providing fluid communication with the drainage outlet port 42 during drainage cycles, and selectively providing fluid communication with the irrigant inlet port 44 during an irrigation cycle of the bladder drainage and irrigation pump 10. The positioning of the duckbill valves 64, 66 ensures that waste can only exit the bifurcation block chamber 58 through the drainage outlet port 42 and that irrigation fluid can only enter the bifurcation block chamber 58 through the irrigant inlet port 44.

[0050] The drainage outlet port 42 and the irrigant inlet port 44 may be color coded to help intuitively distinguish them from one another, such as providing the drainage outlet port 42, and / or a drainage tubing connector associated therewith, in a red color, and providing the irrigant inlet port 44, and / or an irrigant fluid tubing connector associated therewith, in a blue color. Alternatively or additionally, a red-colored indicator may be provided on the removable front lid 30 at a position that is adjacent the drainage outlet port 42, when theremovable front lid 30 is secured to the partition 34 of the housing subassembly and a bluecolored indicator may be provided on the removable front lid 30 at a position that is adjacent the irrigant inlet port 44 when the removable front lid 30 is secured to the partition 34 of the housing subassembly.

[0051] A user interface of the bladder drainage and irrigation pump 10 is preferably intuitive, with only a pair of push buttons for a user to selectively initiate operation of drainage or irrigation cycles of the system. For instance, the pushbuttons may include a drainage cycle initiation button DB that may be identified with adjacent indicia such as “Drain” in raised lettering, as well as an irrigation cycle initiation button IB that may be identified with adjacent indicia such as “Irrigate” in raised lettering. The raised lettering is helpful for users who may be visually impaired or to aid identification of the respective pushbuttons when using the system in a dark room. The push buttons DB, IB are preferably arcade game style buttons that are easily depressed and illuminate when the respective cycle is active, and do not lock down after each of the buttons is released. Such push buttons DB, IB also avoid the need to have an idle mode that may be required with the use of alternate types of activation switches. The user interface may further include a warning indicator W, such as a light-emitting diode (LED), covered by a light-transmissive (transparent or translucent) LED cap 68. The warning indicator W can be configured to flash when the bladder drainage and irrigation pump system 10 experiences a fault or unexpected condition, as explained in further detail below. When illuminated, the warning indicator W is preferably visible from a distance of at least 4m, so as to be easily seen by a care provider.

[0052] Turning, for example, to FIGs. 13 and 22, the housing subsystem of the bladder drainage and irrigation pump system 10 may include a base plate 70, a rear wall 72, sidewalls 74, the partition 34, and the removable front lid 30. A top plate 76, which includes apertures for the drainage cycle initiation button DB, the irrigation cycle initiation button IB, and the LED cap 68 covering the warning indicator W, is also provided as part of the housing subsystem. A pair of integral handles 78 preferably extend from one of the sidewalls 74 to the other, which handles 78 may be arch-like in appearance. It should be appreciated that the aesthetic or ornamental aspects, or overall configuration, of the combination of components of the housing subsystem may take other forms and is not dictated by function. The housing subsystem may further include a plurality of pedestals or feet 80 to provide stability. A grip strip may be provided on, for example, one or each of the sidewalls 74 to help provide a secure grip, particularly when holding the bladder drainage and irrigation pump system 10 in one hand. Sound dampening material can be included in the housing subsystem, and / or active noise canceling equipment can be added, to attenuate noise from operation of the peristaltic pump 12.

[0053] As illustrated in FIG. 14, the bifurcation block 54 may be selectively secured to the partition 34 by upper ribs 82 and lower ribs 84 provided on the bifurcation block 54, which are received in complementary upper grooves 86 and lower grooves 88 provided, respectively, in upper and lower bifurcation block support plates 90, 92 that project forwardly of the partition 34. To fortify isolation of sensitive components in a housing cavity defined by the partition 34 from liquid passing through the pump subsystem, the sidewalls 74 the baseplate 70, the top plate 76, and the rear wall 72, a pair of sealing gaskets 90, which may take the form of silicone seals, may be provided, one between the partition 34 and the sidewalls 74 and the other between the rear wall 72 and the sidewalls 74.

[0054] As illustrated in FIGs. 5a, 5b, an electrical subsystem of the bladder drainage and irrigation pump system 10 may include, a controller 94, such as an Arduino Nano board (Arduino S.r.l, Monza e Brianza, Italy), a reversable motor driver 96 that allows the peristaltic pump 12 to operate in a bidirectional manner, a rechargeable battery 98, a voltage stepdown unit 100, to step down voltage from the rechargeable battery from 14.8V to, for example, 12V, and a circuit board 102 to host all internal wiring. The controller may include an input / output port, such as a Mini-B USB port, to facilitate updates to programming logic of the bladder drainage and irrigation pump system 10, perform diagnostic checks, or obtain data to provide to a medical professional concerning the urostomate, such as frequency of use and volume of urine drained during each use.

[0055] When the pressure sensor 16 detects that a change in pressure in a catheter in fluid communication with the catheter-side port 20, or that flow rate through the length of flexible tubing 14, exceeds a certain limit, the controller cuts power to the reversible motor driver 96, thereby causing the peristaltic pump 12 to automatic shut off, preferably within 500 ms. If the controller 94 determines the bladder drainage and irrigation pump system 10 is operated in an unexpected manner, such as an attempt is made to initiate the irrigation cycle (such as by pressing the “Irrigate” button, IB, before the “Drain” button DB has been pressed and the drain cycle completed), the controller will cause the warning indicator W to illuminate and will cut power to the reversible motor driver 96. The controller 94 may be programmed such that upon detection of such an unexpected event or fault, in addition to illumination of the warning indicator W, power to the reversible motor driver 96 is cut, requiring a hard reset, or toggling of an off / on power switch 110, for the device to operate.

[0056] A full bladder B may contain anywhere from 300 to 600 ml of fluid. By providing the pressure sensor 16 in line with fluid flow, the device can measure pressure in the bladder B of a urostomate. When a change in pressure is detected, such as when the open distal end of the catheter tube encounters the bladder wall, that is indicative of the bladder being adequately or substantially drained. The controller 94, which is in electrical communicationwith the pressure sensor 16, can immediately stop the peristaltic pump 12, so as to avoid subjecting an empty bladder to negative pressure unnecessarily.

[0057] While a manual switching from drainage to irrigation is one preferred embodiment of the present disclosure, it is recognized that the controller 94 could be implemented in a manner that provided for automatic switchover from a urine drainage cycle to an irrigation fluid introduction cycle during which irrigant is pumped into the bladder B, and / or from an irrigation fluid introduction cycle to a used irrigant drainage cycle.

[0058] The system does not permit irrigation to commence before a drainage cycle has occurred, so as to avoid over-filling the bladder B. The components of the bladder drainage and irrigation pump system 10 are preferably selected to promote portability. In a preferred embodiment, the entire system weighs 5.1 lbs. and may be packed into a backpack to facilitate transportation.

[0059] Even as the battery charge drains down, the device continues to perform well by virtue of its principle of operation, which involves redefining a reference pressure used by the controller as a baseline each time the device is turned on and used. Using the pressure sensor 16 that is in line with ( / .e., in direct fluid communication with) liquid in the flexible tubing 14 passing through the peristaltic pump 12, the controller 94 collects pressure readings from the pressure sensor 16 for approximately the first 5 seconds the device is on and averages its readings. This average pressure value is defined to be the reference pressure for the specific instance of use as these readings are taken when the bladder B is relatively full. As the device continues to drain the bladder B, the controller 94 is continually collecting pressure readings from the pressure sensor 16. Each pressure reading is normalized to the reference pressure. Once the change in pressure from that reference pressure is below a negative threshold or above a positive threshold, indicative of the catheter encountering the bladder wall, the controller 94 will immediately stop operation of the peristaltic pump 12 by interrupting power to the reversible motor driver 96. The user then makes sure the irrigation tubing 48 is connected to an adequate volume of irrigant in the irrigation fluid reservoir 52 and presses the “Irrigate” button IB to commence the irrigation operation.

[0060] The encoder associated with the peristaltic pump 12 is interrogated by the controller 94 to determine how fast the rollers of the peristaltic pump 12 are spinning. Based on the rate of rotation of the rollers of the peristaltic pump 12, the controller calculates how much time it would take to pump 70 ml of sterile irrigant fluid, such as saline, and that is the duration of time the controller 94 will operate the peristaltic pump 12 during the irrigation operation. Because the calculation is dynamic and calibrates to the current rate of rotationof the rollers of the peristaltic pump 12, variations in the charging level of the rechargeable battery 98 do not affect the ability of the device to complete a successful irrigation cycle by delivering a full 70 ml of saline to the bladder. Alternatively, it is recognized that a flow sensor could be used, which would be more accurate than time to measure the amount of fluid pumped. Instead of a pressure sensor 16 in direct fluid communication with fluid in the length of flexible tubing 14, it is recognized that a suitable proxy sensor that provides data indicative of actual pressure of liquid within the tubing 14 could be used.

[0061] While various features have been described herein, it will be understood that variations may be made thereto that are still considered within the scope of the appended claims.

Claims

CLAIMS\Ne claim:1 . A bladder drainage and irrigation pump system comprising: a pump; a reversible motor in driving communication with the pump; a length of flexible tubing disposed in relation to the pump such that the pump is configured, when in operation, to actuate fluid through the length of flexible tubing; a catheter-side port on one side of the pump; a pressure sensor in fluid communication with the length of flexible tubing and the catheter-side port; a bifurcation block including a first tubing connector, in fluid communication with the flexible tubing, the first tubing connector opening on an interior of the bifurcation block to a bifurcation block chamber; a drainage outlet port having a first end in fluid communication with the bifurcation block chamber and a second end connectable to a length of drainage tubing; and an irrigant inlet port in fluid communication with the bifurcation block chamber and a second end connectable to a length of tubing that is to be placed in fluid communication with a sterile irrigation fluid; a controller in operable communication with the reversible pump motor; and a user interface in operable communication with the controller.

2. The bladder drainage and irrigation pump system of claim 1 , the first tubing connector being on a first side of the bifurcation block chamber and the drainage outlet port and the irrigant inlet port being on a second side of the bifurcation block chamber that is opposite the first side of the bifurcation block chamber.

3. The bladder drainage and irrigation pump system of claim 1 , wherein the user interface includes a first button that, upon activation, signals the controller to initiate a drain cycle during which the pump causes fluid to move in a direction from the catheter-side port, through the length of flexible tubing, into the first tubing connector of the bifurcation block, and exit through the drainage outlet port.

4. The bladder drainage and irrigation pump system of claim 3, wherein the drainage cycle continues until the controller receives a signal from the pressure sensor indicating of a change in pressure in a catheter in fluid communication with the catheter-sideport indicative of the catheter making contact with a bladder wall, indicating a substantially drained condition of the bladder.

5. The bladder drainage and irrigation pump system of claim 3, wherein the user interface further includes a second button that, upon activation, signals the controller to initiate an irrigation cycle during which the pump causes fluid from an irrigant fluid reservoir in fluid communication with the irrigant inlet port of the bifurcation block to enter the bifurcation block through the irrigant inlet port, through the length of flexible tubing, and exit through the catheter-side port.

6. The bladder drainage and irrigation pump system of claim 5, wherein the irrigation cycle continues until the controller determines the pump has operated for a duration substantially equal to the amount of time to move a volume of fluid through the length of flexible tubing that is no greater than a volume of sterile irrigant fluid that, upon initiation of the irrigation cycle, is in an irrigant fluid reservoir in fluid communication with the irrigant inlet port.

7. The bladder drainage and irrigation pump system of claim 1 , wherein the pump is a peristaltic pump.

8. The bladder drainage and irrigation pump system of claim 7, further comprising an encoder in communication with the peristaltic pump and the controller to facilitate determination by the controller of a rate of rotation of one or more rollers of the peristaltic pump.

9. The bladder drainage and irrigation pump system of claim 1 , wherein the controller collects pressure readings from the pressure sensor for an initial time duration after initiation of the drainage cycle, calculates an average of a plurality of readings from the pressure sensor during the initial time duration, which average pressure value is defined to be a reference pressure for a specific instance of use as these readings are taken when the bladder is relatively full, the controller configured to continually collect pressure readings from the pressure sensor during continued operation of the peristaltic pump during the drainage cycle, each pressure reading being normalized to the reference pressure, and the controller being further configured, upon determination that the change in pressure from that reference pressure is below a negative threshold or above a positive threshold, indicative of the catheter encountering the bladder wall, immediately stop operation of the peristaltic pump by interrupting power to the reversible motor driver.

10. The bladder drainage and irrigation pump system of claim 1 , wherein the user interface further includes a warning indicator that provides an indication of a fault.11 . The bladder drainage and irrigation pump system of claim 10, wherein the controller is configured to disable operation of the pump upon detection of the fault.

12. The bladder drainage and irrigation pump system of claim 1 , further comprising a housing including a partition isolating at least the controller and the user interface from the pump, the length of flexible tubing, and the bifurcation block.

13. The bladder drainage and irrigation pump system of claim 12, wherein the partition includes a lower plate and an upper plate spaced from the lower plate a distance that accommodates a height of the bifurcation block between the lower plate and the upper plate.

14. The bladder drainage and irrigation pump system of claim 13, further comprising a pair of sealing gaskets intermediate the partition and adjacent portions of the housing.

15. The bladder drainage and irrigation pump system of claim 13, wherein a top wall of the bifurcation block includes a pair of raised ribs configured to be received in a pair of complementary channels provided in the upper plate, and a bottom wall of the bifurcation block includes a pair of raised ribs configured to be received in complementary channels provided in the lower plate.

16. The bladder drainage and irrigation pump system of claim 12, wherein the housing further comprises a base plate, and a plurality of stabilizing feet on an underside of the baseplate.

17. The bladder drainage and irrigation pump system of claim 1 , further comprising a rechargeable battery in electrical communication with at least the pump motor, the controller, and the user interface.

18. The bladder drainage and irrigation pump system of claim 1 , and the bifurcation block including a first one-way valve disposed intermediate the drainage outlet port and the bifurcation block chamber and positioned to only permit flow in a direction fromof the bifurcation block chamber out through the drainage outlet port, and a second one-way valve disposed intermediate the irrigant inlet port and the bifurcation block chamber and positioned to only permit flow in a direction from the irrigant inlet port into the bifurcation block chamber.

19. The bladder drainage and irrigation pump system of claim 18, wherein each of the one-way valves is a duckbill valve.

20. The bladder drainage and irrigation pump system of claim 19, wherein each of the duckbill valves is received in an annular recess of the bifurcation block between the bifurcation block chamber and the respective drainage outlet port and the irrigant inlet port.

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