System for analyzing urine flowing from an intermittent urinary catheter and / or monitoring catheter-associated urinary tract health

Abstract

A smart drainage member for monitoring catheter-associated urinary tract health and a system thereof are disclosed. The drainage member provides an indentation accommodating a sensor assembly having a power unit activated by inductive coupling with an external transmitting device. The system includes the smart drainage member, an external transmitting device and a computing device. An external analyzing device provides a sensor assembly energized by onboard battery. The system includes the external analyzing device and a computing device. Both systems are configured to provide at least one characteristic of the urine to the computing device for analysis.

Description

Attorney Docket No. 3400-0376.01 (837PCT)System for Analyzing Urine Flowing from an Intermittent Urinary Catheter and / or Monitoring Catheter-Associated Urinary Tract Health The present application claims the benefit of and priority to U.S. Provisional Application 63 / 754,906, filed February 6, 2025, which is hereby incorporated herein by reference.Field of the Disclosure

[0001] The present disclosure generally relates to devices and systems for collecting urinary data during intermittent catheterization. The present disclosure also relates to devices and systems for monitoring catheter-associated urinary tract health. More particularly, the present disclosure relates to a “smart” drainage member associated with a urinary catheter that collects and processes urinary data at catheterization.

[0002] Intermittent catheterization is a procedure that includes periodically inserting a urinary catheter into the bladder to drain urine from the bladder. After the bladder has been drained, the urinary catheter is removed from the bladder. The use of intermittent urinary catheters can be associated with an increased risk of urinary tract infections (UTIs). Despite being a common and effective technique for managing urinary issues, there are factors such as the introduction of bacteria during catheterization, multiplication of contaminant bacteria in the residual urine in the bladder for a prolonged period, and inadequate hygiene practices during catheter insertion and removal, etc. that contribute to increasing the risk of UTIs in individuals using intermittent catheters.

[0003] Thus, there remains a need for devices integrated with control and / or functions that analyze urine during intermittent catheterization, monitor urinary tract health, and / or assist in assessing the potential risk of UTIs.

[0004] There are several aspects of the present subject matter that may be embodied separately or together in the devices and systems described and claimed below. These aspects may be employed alone or in combination with other aspects of the subject matter described herein, and the description of these aspects together is not intended to preclude the use of these aspects separately, or the claiming ofAttorney Docket No. 3400-0376.01 (837PCT)such aspects separately or in different combinations as set forth in the claims appended hereto.

[0005] In one aspect, a drainage member for use with a urinary catheter that has a coupling end to connect with the drainage member. The drainage member includes a housing having a wall with an indentation therein. The housing has a distal end with an outlet opening and a proximal end with an inlet opening. The outlet and inlet are in fluid communication with a channel extending within the drainage member. Furthermore, the drainage member is configured to connect with the catheter, wherein the catheter has a catheter lumen extending therein. The drainage member is connected to the catheter in a cascaded arrangement such that the channel and the catheter lumen are aligned to form a mutual passage, providing fluidic communication and allowing urine to flow through the mutual passage. The drainage member also includes a sensor assembly with a circuitry wiredly connected to at least one sensing module. The sensor assembly further includes a power unit for powering up the circuitry. The indentation in the wall of the housing is sized for accommodating at least the sensor assembly therein and, wherein the at least one sensing module is arranged inside of the wall of the housing. The at least one sensing module senses at least one characteristic of the urine and / or urinary tract and produces a signal associated with the at least one characteristic.

[0006] In another aspect, an external drainage device for use with a drainage member associated with a urinary catheter. The external drainage device includes a housing with a wall with an indentation therein. The housing has a distal end with an outlet opening and a proximal end with an inlet opening. The outlet and inlet are in fluid communication with a conduit extending within the external device. The external device connects with the drainage member, wherein the drainage member has a channel extending therein. The catheter has a catheter lumen extending therein. The catheter lumen, conduit, and channel are in a cascaded arrangement, wherein the conduit, channel, and catheter lumen are aligned to form a mutual passage. The mutual passage provides fluidic communication therethrough, thereby allowing urine to flow therethrough. A sensor assembly includes a circuitry wiredly connected to at least one sensing module, wherein the sensor assembly further includes a power unit having a battery for powering up the circuitry. The indentation of the wall is sized to accommodate the at least the sensor assembly therein. The at least one sensing module is arranged on the inside of the wall and senses at least one characteristic ofAttorney Docket No. 3400-0376.01 (837PCT)the urine and / or urinary tract. The at least one sensing module is configured to produce a signal associated with the at least one characteristic.

[0007] In another aspect, a system for analyzing urine flowing from a urinary catheter includes the catheter and a drainage member associated with the catheter, wherein the drainage member comprises a housing having a housing wall with an indentation therein, the housing having a distal end including an outlet opening and a proximal end including an inlet opening, the outlet opening and inlet opening being in fluid communication with a channel extending within the drainage member; wherein the drainage member is configured to be connected to the catheter in a manner wherein the channel of the drainage member and a catheter lumen of the catheter are in a cascaded arrangement such that the channel and the catheter lumen are aligned to form a mutual passage; a sensor assembly comprising circuitry connected to at least one sensing module, wherein the sensor assembly further comprises a power unit for powering up the circuitry; and wherein the sensing assembly and at least one sensing module are in the indentation of the housing wall and the at least one sensing module is configured to sense at least one characteristic of the urine and / or urinary tract and to produce a signal associated with the at least one characteristic; and the system further comprises an external transmitter comprising transmitter coil, a transmitter power supply and an oscillator circuit; wherein the external transmitter transfers power to the power unit through electromagnetic induction.

[0008] In another aspect, a system for analyzing urine flowing from a urinary catheter, includes an external analyzing device, the catheter, a drainage member associated with the catheter; wherein the external analyzing device comprises a housing having a wall with an indentation therein, the housing having a distal end with an outlet opening and a proximal end with an inlet opening , the outlet opening and the inlet opening being in fluid communication with a conduit extending within the external analyzing device; wherein the external analyzing device is configured to connect with the drainage member having a channel extending therein the conduit, channel and catheter lumen of the catheter being in a cascaded arrangement such that the conduit, channel and the catheter lumen are aligned to form a mutual passage; a sensor assembly comprising circuitry connected to at least one sensing module, wherein the sensor assembly further comprises a power unit for powering up the circuitry; and wherein the sensor assembly and the at least one sensing module are arranged in the indentation, the at least one sensing module configured to senseAttorney Docket No. 3400-0376.01 (837PCT)at least one characteristic of the urine and / or urinary tract, the at least one sensing module being configured to produce a signal associated with the at least one characteristic; and the system further comprises an external transmitter comprises a transmitter coil, a transmitter power supply and an oscillator circuit; wherein the external transmitter transfers power to the power unit through electromagnetic induction.Brief Description of the Drawings

[0009] Fig. 1A is an exemplary system for monitoring a patient’s intermittent catheterization regime.

[0010] Fig. 1B is a perspective view of an intermittent urinary catheter with an exemplary smart drainage member.

[0011] Fig. 2A is an enlarged perspective view of the drainage member shown in Fig. 1B.

[0012] Fig. 2B is an enlarged perspective view of the drainage member shown in Fig. 2A.

[0013] Fig. 20 is a perspective view of the drainage member of Fig. 2A, showing the sensor assembly, sensor, and test pad.

[0014] Fig. 2D is an enlarged perspective view of the drainage member shown in Fig. 2A.

[0015] Fig. 2E is a perspective view of an exemplary circuit of a sensor assembly.

[0016] Fig. 2F is a perspective view showing the circuit positioned within the drainage member.

[0017] Fig. 2G is a schematic block diagram of an exemplary circuit of the power source employed in the smart drainage member.

[0018] Fig. 3A is a perspective view of an exemplary embodiment of a urine analyzing device.

[0019] Fig. 3B is a perspective view of the urine analyzing device of 3A shown before being connected to a drainage member of a urinary catheter.

[0020] Fig.3C is a perspective view of the urine analyzing device of Fig.3A shown without a circuit assembly in the indentation of the device’s wall.

[0021] Fig. 3D illustrates a cross-sectional view of the exemplary urine analyzing device, taken along line A-A in Fig. 3A.Attorney Docket No. 3400-0376.01 (837PCT)

[0022] Fig. 4 is a perspective view of an exemplary circuit assembly in accordance with the present disclosure.

[0023] Fig. 5A is a schematic block diagram of an exemplary circuitry that may be used in a drainage member or analyzing device.

[0024] Fig. 5B is a schematic block diagram of an exemplary circuitry that may be used in a drainage member or analyzing device.

[0025] Fig. 6 is a block diagram illustrating an exemplary external computing device.Description of the Illustrated Embodiments

[0026] The embodiments disclosed herein are for the purpose of providing a description of the present subject matter, and it is understood that the subject matter may be embodied in various other forms and combinations not shown in detail. Therefore, specific embodiments and features disclosed herein are not to be interpreted as limiting the subject matter as defined in the accompanying claims.

[0027] The present application provides a “smart” drainage member and / or analyzing device that may be associated with a urinary catheter. The drainage member and / or analyzing device incorporates a sensor assembly (which also may be referred to as a gauge assembly). The sensor assembly may be powered by and / or include any suitable power source. For example, the sensor may be powered by Transcutaneous Energy Transfer (TET) systems. The sensor assembly can be linked to a smart device and allows tracking of catheter use to aid in determining and diagnosing bladder and urethral health conditions. The smart device may be a phone, tablet, computer, watch, or any other suitable device.

[0028] Devices for analyzing urine and / or monitoring catheter-associated urinary tract health and the system thereof according to the present disclosure and their individual components may be variously configured without departing from the scope of the present disclosure, but in one embodiment, an analyzing / monitoring system is configured as shown in Fig. 1 .

[0029] Fig. 1 illustrates an exemplary urine analyzing system and / or catheter-associated urinary tract health monitoring system 1 , which includes a smart drainage member 10 associated with a urinary catheter 11 and, optionally, a portable computing device 2 (mobile phone, smartphone, tablet, watch, or any other suitable portable computing device). Drainage member 10 may be a funnel, connector that connects toAttorney Docket No. 3400-0376.01 (837PCT)a collection bag, or any external device associated with an intermittent urinary catheter. The urinary catheter may be a disposable single-use catheter or a reusable multiple-use catheter. As exemplified, the drainage member 10 may be a reusable multiple-use funnel.

[0030] (A) Drainage Member

[0031] In one embodiment, drainage member 10 (such as the illustrated funnel) houses circuitry interfacing with a wireless external powering device. The powering device 27 may include, for example, a battery unit 27b, oscillator circuit 27c (such as aa DC-AC amplifier), and RF transmitter antenna 27a (such as a coil). In one alternative embodiment, the portable computing device 2 and external powering device 27 may be the same device, or the powering device 27 may be an accessory that is operatively connected to the portable computing device 2. For example, the powering device 27 may be plugged into a port of the computing device 2. The circuitry housed in drainage member 10 wirelessly receives power from external device 27 at a receiving interface via inductive coupling.

[0032] In another embodiment of an exemplary catheter, the circuitry interfaces with urine flow at a first interface (a receiving interface) configured to provide an input channel to capture urinary data. Optionally, the circuitry interfaces with a portable computing device 2 at a second interface (a transmitting interface) configured to provide an output channel establishing communication between the drainage member 10 and the external computing device 2 within the monitoring system 1.

[0033] In the exemplified drainage member 10, as illustrated in Fig. 1A, the drainage member 10 is configured to wirelessly communicate with the portable computing device 2. Optionally, computing device 2 is configured to communicate with a server of the health monitoring system, e.g., via a network such as a cloud-based network. The server may be operated and / or controlled by the catheter manufacturer, a healthcare facility, and / or a service center. Appliance data (urinary data of any of the urinary tract health monitoring systems disclosed herein) or parametric data based on the appliance data (urinary data in the health monitoring system) are obtained from at least one sensing module assembly included in and / or operatively connected to the circuitry housed in the drainage member 10. Drainage member 10 processes the appliance data and / or parametric data based on the appliance data to determine the sensed data, which will be later transmitted to computing device 2 for storage and / or analysis. In the illustrated catheter-associated urinary tract health monitoring systemAttorney Docket No. 3400-0376.01 (837PCT)1 , computing device 2 is a mobile phone. However, computing device 2 may be embodied as another handheld device, such as a tablet device, or a wearable, such as a watch or other wrist-worn electronic device. Accordingly, drainage member 10 is configured to collect urinary data and transmit the data to the portable computing device 2.

[0034] Fig. 1B illustrates a drainage member 10 associated with an intermittent urinary catheter 11. As shown in the figure, drainage member 10 includes a flexible housing 12 made from any suitable material, such as an elastomeric material. The material may be, for example, a polyolefin. As illustrated in Figs. 2A and 2B, drainage member 10 may be tapered in shape, wherein the surface of the drainage member 10 may have a cross-sectional width that increases along the longitudinal length of the drainage member 10 from a proximal end 17a to a distal end 13a. The proximal end includes an inlet opening 17b, and the distal end includes an outlet opening 13b to drain urine into a toilet. The inlet opening 17b is in fluid communication with a channel 13c (shown in Fig. 2C) extending within the drainage member 10 and a catheter lumen 18 (shown in broken lines) extending within the urinary catheter 11. The urinary catheter may be lubricated and inserted into the urethra.

[0035] The inlet opening 17b in the proximal end 17a of drainage member 10 receives catheter coupling end 15a to attach drainage member 10 to catheter 11. Inlet opening 17b is configured to be in fluid communication with catheter lumen 18 at the catheter coupling end 15a, which has an outlet port 15b. Drainage member 10 connects with catheter 11 in a cascaded arrangement such that channel 13c (best shown in Fig. 2b) and the lumen 18 are aligned to form a mutual passage, providing a fluidic communication therethrough and thereby allowing urine to flow through the mutual passage. As exemplified, engaging catheter 11 to drainage member 10 may be achieved by inserting the coupling end 15a of catheter 11 into the inlet opening 17b at the proximal end 17a of drainage member 10, where the contours of their contacting surfaces are complementary. The drainage member 10 and catheter 11 may be connected by adhesive, melting, welding, or any other suitable connection method. This ensures a tight, leak-proof connection between the two components.

[0036] During catheterization, the user advances catheter 11 through the urethra until its proximal tip 19a enters the bladder. Urine then flows into one or more openings or eyelets 19b adjacent to and / or in the proximal tip 19a and proximally through the catheter lumen 18. The user may hold the coupling end 15a of catheter 11 and / orAttorney Docket No. 3400-0376.01 (837PCT)drainage member 10 to direct urine drainage into a toilet. In an alternative embodiment, drainage member 10 may be connected or sealed to a collection bag (not shown).

[0037] As shown in Figs. 1 B and 2A, drainage member housing 12, and therefore drainage member 10, includes a wall 14 having an indentation 16a. The indentation 16a may be formed when the wall is being shaped or may be carved out from the wall of an already formed drainage member housing. For example, indentation 16a may be cut or carved out of the drainage member wall’s outer surface adjacent to distal end 13a of drainage member 10. The carving of indentation 16a may be performed via laser cutting, lithography, or any other suitable cutting method. In another alternative, when the drainage member housing 12 is made by injection molding, indentation 16a is formed during the molding process.

[0038] In one alternative, drainage member 10 may be a reusable or durable component that releasably connects to catheter 11 . Figs. 1 B and 2A-2D illustrate an exemplary, optional locking mechanism of drainage member 10. As exemplified, the locking mechanism releasably attaches drainage member 10 to catheter 11 , optionally, with the contacting surfaces of drainage member 10 and catheter 11 forming a liquid-tight seal between the two. When present, the seal will prevent urinary fluid leakage during catheterization. As further exemplified, the locking mechanism is moveable between an engaging and disengaging position. In one alternative, the locking mechanism is a bayonet mount or connector. Turning to Figs. 2A, 2B, and 2D in one alternative, the structure of the locking mechanism includes a receptacle 17c (e.g., a slot or hole) defined at the proximal end 17a of the drainage member 10, configured to engage with a latching element 15c (e.g., a pin or protrusion) (Fig. 1B and 2F) at the coupling end 15a of the urinary catheter 11 to secure drainage member 10 and the urinary catheter 11 to enable fluidic communication. The locking mechanism is adapted to mechanically couple or de-couple the drainage member 10 from the catheter 11 . Specifically, the locking mechanism may be transitioned between a latched state at the engaging position configured to restrict the movement of the receptacle 17c relative to the latching element 15c or the movement of latching element 15c relative to receptacle 17c and an unlatched state at the disengaging position configured to allow the movement of the receptacle 17c relative to the latching element 15c or the movement of latching element 15c relative to receptacle 17c. In this alternative, the locking mechanism is a twist / bayonet lock, achieved throughAttorney Docket No. 3400-0376.01 (837PCT)rotational engagement between the receptacle 17c and a corresponding latching element 15c, securing the two components via a twisting motion. The rotational movement results from rotating drainage member 10 and catheter 11 relative to one another. In other alternatives, the locking mechanism may be achieved by push fit lock, snap fit lock, or the like.

[0039] Now turning to sensor assembly 20 and the at least one sensing module 22, as illustrated in Figs. 2D and 2E. Sensor assembly 20 includes a processor 21 , and active components include therewith and / or connected thereto. Active components may include, but are not limited to, at least one sensing module 22 (which may be a plurality of sensing elements), a power unit 26, a signal conditioning unit 25, and / or a transceiver / communication module 23. The at least one sensing module 22 of an exemplary drainage member 10 may include, for example, a colorimeter or color sensor. Any other sensor type that senses urine and / or urinary tract (urethra, bladder, etc.) characteristics may be used for assessing bladder and / or urinary tract health. As shown in the figure, the signal conditioning unit 25 includes an amplifier 25a and signal filter-regulator 25b. The signal conditioning unit 25 conditions the urine signal embedded with urine data captured from the sensing module 22, converts the signal to data to be processed in the processor 21 so that it is ready for transmitting to an external computing device 2.

[0040] In Figs. 2E and 2F, sensor assembly 20 and its subassembly may be embedded with the at least one sensing module 22 on or in the substrate 20a. The sensor assembly 20 and the color sensor 22 may be located in the indentation 16a. Test pad 24 may be located in the drainage member channel 13c. The test pad 24 may be attached to an inner surface of drainage member 10. Specifically, in the exemplary drainage member 10, as illustrated in Figs. 2A-2D, indentation 16a may be sized and shaped to accommodate the sensor assembly 20. Indentation 16a includes a hole 16b sized and shaped to accept color sensor 22. Drainage member 10 may include a second indentation 16c that is sized and shaped to accommodate test pad 24. Sensor assembly 20 and test pad 24 may be affixed in their respective indentations 16a, 16c by any suitable manner. For example, sensor assembly 20 and test pad 24 may be held by friction fit, snap fit, melting of the drainage member housing, or adhesive. The test pad may also be attached to the drainage member's inner surface without using an indentation.

[0041] Optionally, as illustrated in Fig. 2F, drainage member 10 is provided with aAttorney Docket No. 3400-0376.01 (837PCT)sealing element 28 that forms a liquid-tight seal to the sensor assembly 20. As exemplified, the sensor assembly 20 is sealed by being overlaid with the sealing element 28 so that the circuitry provided thereon may be protected from a hydrophilic coating, lubricant applied to the catheter, and / or being wetted by the urine flow. Optionally, the sealing element 28 may be UV-curable epoxy resin.

[0042] Active Components on the Subassembly

[0043] (I) Power Unit - Inductive Coupling Power

[0044] According to an embodiment of drainage member 10, it includes a power unit of inductive coupling, as illustrated in Fig. 2G. The power unit 26 may comprise a receiver antenna 26a, which may be a coil (also receiver coil / secondary coil), as exemplified. The receiver antenna 26a on the sensor assembly circuitry of drainage member 10 captures the magnetic field generated by an external power device 27 (Figs. 1 and 2G), which may be an external transmitter.

[0045] Turning to the active components included in the external power device 27 as illustrated in Figs. 1 and 2G, the external power device 27 includes another coil 27a (also transmitter coil / primary coil), a transmitter power supply 27b, and an oscillator circuit 27c. In an embodiment, an inductive coupling power option may be used to power up drainage member 10. Inductive coupling is a process where electrical energy is transferred between two coils through a shared magnetic field. In Transcutaneous Energy Transfer (TET) systems, power is transmitted from an external device to an implanted medical device without direct physical contact. As illustrated in Fig. 2G, external transmitter 27 with primary coil 27a is placed near the user and powered by an energy source, such as battery 27b. The power source provides DC power, which is converted to an alternating current AC signal by the oscillator circuit 27c, having a DC-AC converter and an amplifier. The AC signal may then be amplified to the necessary power levels by an amplifier. In an example, the AC signal may be associated with a wireless protocol, such as RF energy, induced by the oscillator circuit 27c, passing through the primary / transmitter coil 27a and generating a magnetic field. As exemplified, the oscillator circuit 27c in TET RF transmitters converts DC power into high-frequency AC power, which is used to drive the primary coil 27a of the TET system to produce the electromagnetic fields for wireless energy transfer. The changing magnetic field from the transmitter coil 27a induces a voltage and thereby induces another alternating current (AC) in the receiver coil 26a in drainage member 10 through electromagnetic induction. The another ACAttorney Docket No. 3400-0376.01 (837PCT)induced in the receiver coil 26a is then rectified and regulated by the associated sensing circuit, which includes a rectifier, filter, and regulator, collectively denoted as 26b, to provide the direct current (DC) power required for energizing the components in the drainage member 10. Optionally, a DC-DC booster or amplifier 26c may be annexed to the sensing circuit 26b to amplify the DC signal if needed.

[0046] Fig. 5A illustrates a schematic block diagram of an exemplary subassembly 120 of the sensor assembly and sensing module included in the drainage member 10 featured with an inductive power supply. In this exemplary subassembly 120, the circuitry may be printed or fabricated on a flexible substrate made from materials such as paper, polyamide, PET, or the like that resides in indentation 16a. The subassembly 120 may include processor 121 , such as MCU, and active components connected thereto including but not limited to memory 116 (optional), at least one sensing module 122, transceiver / communication module 123, signal conditioning unit 125 and a (inductive coupling) power unit 126. In this embodiment, subassembly 120 comprises a circuitry with a receiving interface having at least one input port and a transmitting interface having at least one output port communicating with the user. The at least one input port is configured to receive input from the user and power through inductive coupling. On the other hand, the at least one output port is configured to transmit output to the user. As exemplified, the receiving interface is provided with the inductive coupling (such as RF coupler) power unit 126 that wirelessly tunes with an external transmitter (Figs. 1 and 2G) equipped with an RF energy transmitting circuit when the external transmitter is activated via a resonant frequency (i.e., RF in the example). The external transmitter is carried and used by the user to power up the circuitry and the above-said active components of the drainage member 10 via TET. In an exemplified drainage member 10, the TET may be an RF coupler or any other Tuned Energy Transfer. At the time of use, the user switches ON the external transmitter and thereby wirelessly pairs the external transmitter with the drainage member 10 to enable energy transfer from the transmitter to the catheter. The active components affixed to the inductive power unit 26, as well as the power unit 26 itself, as illustrated in Figs. 2E and 2F — i.e., processor 21 , sensor / sensing module 22, transceiver / communication module 23, amplifier 25a, signal filter-regulator 25b included in signal conditioning unit 25, receiver coil 26a, rectifier / filter / regulator (sensing circuit) 26b, and DC-DC amplifier 26c, described herein are correspondingly referenced in Fig. 5A by adding theAttorney Docket No. 3400-0376.01 (837PCT)numeral ‘100’. Details of the general principle of TET technology or energy transfer via inductive coupling have been described above and will not be reiterated here for efficiency.

[0047] (II) Sensor assembly-sensing module subassembly

[0048] Fig. 5A illustrates an exemplary sensor assembly 120 included in drainage member 10. The at least one input port(s) may connect to the at least one sensing module 122 (corresponding to sensor 22 in Fig. 1), such as a color sensor housed with a receiver 122a, which may be a photodiode and a white light source 122b (such as LED) for sensing the color of the urine. The color sensor may be used with or without a test pad 24. If the color sensor is used without the test pad 24, the white light illuminates the urine, and the receiver / photodiode 122a detects the color of the liquid directly by measuring the reflected light corresponding to red, green, and blue (RGB) combination sensed by the photodiode 122a. Typically, but not exclusively, using a color sensor without a test pad to detect urine color is to assess the physical properties of urine, such as hydration levels and other factors related to overall health. In the case of the test pad 24 being used along with the color sensor 122, the sensor can detect nitrites, leucocytes, pH, or other urine analytes of the patient / user while the urine is discharged. When test pad 24 is used, the photodiode 122a scans and captures the color change reflected from test pad 24. In one embodiment, the scanning may take place during and / or after voiding. The resulting or changing color of the test pad may be caused by a chemical reaction from contact with the urine and its components. Therefore, the test pad 24 is placed near the color sensor, such as opposite to the color sensor 22, as illustrated in Fig. 20. In both cases of the color sensor 122 being used with and without the test pad 24, a signal processing unit (not shown) integrated with the color sensor converts the sensed light intensity readings from RGB channels to a color signal (for example, digital output) that can be interpreted by the sensor assembly processor 121 . The digitized color signal is then compared to a predefined color library stored in the memory of processor 121 to find out the corresponding color codes. Processor 121 may be programmed to execute a machine learning algorithm on the acquired signal to determine both the color and intensity of the reflected light from the test pad 24, using the predefined color library to determine the result (e.g., indicating the presence of a substance or the concentration of an analyte). In another embodiment, the at least one input port(s) may connect to the at least one sensing module 122, such as a camera or charge-Attorney Docket No. 3400-0376.01 (837PCT)coupled device (CCD) that takes an image of the test pad 24 wetted by the urine. Acquiring image may take place during and / or after voiding. In these two embodiments, the supervised machine learning algorithm used is a support vector machine (SVM) that classifies the color (or color of the test pad image), referencing a pre-trained color library based on the input color data provided by the color sensor. The algorithm is trained to detect features on the test pad and classify them based on the Red (R), Green (G), and / or Blue (B) values encoded for each color. Table 1 below shows a snippet of an exemplary color library that may be used in the algorithm.Table 1. Color Library Snippet

[0049] The conditioned signal may be further processed by the processor 121 and converted into a format compatible with the communication protocol or bus connecting the assembly components. This protocol includes SPI, UART, I2C, CAN USB, IEEE1394, or the like. The signal conditioning unit 125 includes an amplifier 125a and signal filter-regulator 125b. The signal conditioning unit 125 conditions the urine signal embedded with urine data captured from the sensing module 122, converting the signal to data to be processed in the processor 121 ready for transmission to an external computing device 2 (Fig. 1). The data may also include product identification information associated with the drainage member 10 (denoted as PID) which is preprogrammed in the processor 121 during a specific configuration or calibration stage. Alternatively, PID may be stored in non-volatile memory within the MCU, such as EEPROM, flash memory, or the like. In another embodiment, the PID may further include embedded information, such as product details, manufacturing date, batch information, etc. On the other hand, computing device 2 equipped with a mobile APP may be registered with the user identification information (UID) through the APP, which may be mapped with the PID preprogrammed in processor 121 of drainage member 10.Attorney Docket No. 3400-0376.01 (837PCT)

[0050] Optionally, the mobile application (mobile APP) may be programmed to retrieve the PID from drainage member 10 after pairing computing device 2 with drainage member 10. The mobile APP may also include mapping the product identification information associated with the drainage member 10 (PID) with the user’s identification information (UID). Such mapping may occur as soon as the computing device 2 is brought within a defined range (i.e., pairing up the devices), depending on the type of wireless communication protocol, such as Bluetooth® in the exemplary system, with the authorization provided by the user through the mobile APP.

[0051] (III) Transceiver Module

[0052] Now turning to the at least one output port, which includes wireless transceiver module 123, as illustrated in Fig. 5A. To transmit the urinary data and / or the identification data from drainage member 10 to computing device 2, a connection between drainage member 10 and computing device 2 needs to be established for pairing up via wireless communication protocol, such as Bluetooth® as exemplified. Other communication protocols may be applicable such as Wi-Fi®, Ethernet, NFC, RFID, cellular, infrared or other optical communications, or the like. Alternatively, the connection may be established by wiring the drainage member 10 and the computing device 2 with a physical cable. In various examples, transceiver / communication module 123 may include an antenna 123a, signal processing unit 123b, and memory 123c. The communication module 123 receives the urinary data and / or ID data processed from processor 121 , recording it in memory 123c for further processing in the signal processing unit 123b. The signal processing unit 123b generates a transmission signal embedded with the data to be transmitted to the external computing device 2.

[0053] (B) Urine analyzing Device

[0054] Fig. 3A and 4 illustrate an embodiment of urine analyzing device 30 featured with a sensor assembly 40. The sensor assembly 40 includes processor 41 , sensor element 42, transceiver module 43, signal conditioning unit 45, and power unit 46. Optionally, the urine analyzing device 30 may employ the same sensor assembly 20 used in the drainage member 10. However, the urine analyzing device 30 differs from the drainage member 10 in its structural configuration. As disclosed in the previous sections, drainage member 10 is configured to engage with a urinary catheter. Urine analyzing device 30, on the other hand, is configured to engage with a drainageAttorney Docket No. 3400-0376.01 (837PCT)member / funnel 50, which does not have any integrated control and / or functions, as illustrated in Fig. 3C.

[0055] (I) Coupling Mechanism

[0056] Turning to Fig. 3A, the urine analyzing device 30 may include a flexible tube 32 made from any suitable material, such as an elastomeric material. The material may be, for example a polyolefin. In other embodiments, tube 32 may be a rigid tube made from a rigid material. As illustrated in Figs. 3A and 3B, the analyzing device 30 may have an elongated tube or body 32 with a wall 34 enclosing a conduit 31 extending therethrough. Tube 32, and thus device 30, has an inlet 37 at one end 33 and an outlet 38 at the opposite end 35. Turning now to Fig. 3B, the inlet 37 is configured to be in fluid communication with conduit 31 and channel 53c extending within a drainage member 50. The drainage member 50 is connected to a catheter (not shown).

[0057] When urine analyzing device 30 is in use with the drainage member 50 and the catheter, the analyzing device 30 connects with the drainage member 50 and the catheter in a cascaded arrangement such that the conduit 31 , channel 53c, and catheter lumen (extending within the catheter) are aligned to form a mutual passage, providing a fluidic communication therethrough and thereby allowing urine to flow through the mutual passage. Outlet 38 is configured for draining urine into a toilet or collection bag (not shown).

[0058] The proximal end 30a of analyzing device 30 defines a coupling interface 33. Fig. 3B also illustrates an exemplary coupling mechanism of the analyzing device 30. As exemplified, the coupling mechanism holds analyzing device 30 to drainage member 50 in place, with the contacting surfaces of analyzing device 30 and drainage member 50 forming a liquid-tight seal between the two. The seal will prevent urinary fluid leakage during catheterization. As exemplified, the coupling mechanism is moveable between an engaging and disengaging position. In one alternative, the structure of the locking mechanism includes the coupling interface 33 (e.g., a slot or hole) at the proximal end 30a of the analyzing device 30, configured to engage with a latching interface 53d (e.g., another slot or hole sized and shaped to complementarily accommodate the coupling interface 33) formed at exit port 53b of the funnel 50. Drainage member 50 has a similar structural configuration as drainage member 10 but differs in that a sensor assembly is present in drainage member 10, absent from drainage member 50. The corresponding features among drainage member 10 andAttorney Docket No. 3400-0376.01 (837PCT)drainage member 50 and the structural configuration will not be reiterated here. Engaging the coupling interface 33 with the latching interface 53d secures the analyzing device 30 and the funnel 50 to enable fluidic communication. The coupling mechanism is adapted to mechanically and releasably couple analyzing device 30 with drainage member 50 or de-couple analyzing device 30 from drainage member 50. Specifically, the coupling mechanism may be transitioned between a latched state configured to restrict the movement of the coupling interface 33 relative to the latching interface 53d or the movement of the latching interface 53d relative to the coupling interface 33, and an unlatched state configured to allow the movement of the coupling interface 33 relative to the latching interface 53d or the movement of the latching interface 53d relative to the coupling interface 33. In this alternative, the locking mechanism is a twist lock, achieved through rotational engagement between the coupling interface 33 and a corresponding latching interface 53d, securing the two components via a twisting motion. In other alternatives, the locking mechanism may be achieved by push fit lock, snap fit lock, or the like.

[0059] Fig. 30 illustrates the analyzing device body / tube 32 defined by wall 34 having an indentation 36 thereon. The indentation 36 may be formed when the wall is being shaped or may be carved out from the wall of an already formed drainage member housing. For example, indentation 36 may be cut or carved out of the drainage device wall’s outer surface adjacent to inlet 37. The carving of indentation 36 may be performed via laser cutting, lithography, or any other suitable cutting method. In another alternative, when the drainage device body 32 is made by injection molding, indentation 36 is formed during the molding process.

[0060] Now turning to sensor assembly 40 and the at least one sensing module 42, as illustrated in Fig. 4, the sensor assembly 20 includes a processor 41 , and active components include therewith and / or connected thereto. Active components may include, but are not limited to, at least one sensing module 42 (which may be a plurality of sensing elements), a power unit 46, a signal conditioning unit 45 and / or transceiver / communication module 43. The at least one sensing module 42 may be, for example, a colorimeter or color sensor. Any other sensor type that senses urine and / or urinary tract (urethra, bladder, etc.) characteristics that may be used for assessing bladder and / or urinary tract health.

[0061] In Fig. 4, sensor assembly 40 and its subassembly may be embedded with the at least one sensing module 42 on the substrate 40a. The sensor assembly 40Attorney Docket No. 3400-0376.01 (837PCT)and the color sensor 42 may be located in the indentation 36. Similar to the structural configuration of the drainage member 10, the indentation 36 of the exemplary analyzing device 30, as illustrated in Fig. 3D, may be sized and shaped to complementarily accommodate the sensor assembly 40 and the color sensor 42. A second indentation 36a, in the inner surface of body 32, may be sized and shaped to accommodate test pad 44. Sensor assembly 40 and test pad 44 may be affixed in their respective indentations 36, 36a by any suitable manner. For example, sensor assembly 40 may be held by friction fit, snap fit, melting of the drainage member housing, or adhesive.

[0062] Sensor assembly 40 further includes power unit 46 with a rechargeable battery 46a integrated on substrate 40a. The AC supply from the power terminal is rectified and regulated by the associated sensing circuit, which includes a rectifier, filter, and regulator, collectively denoted as 46b, to provide the direct current (DC) power required for charging the battery 46a. Optionally, a DC-DC booster or amplifier 46c may be annexed to the sensing circuit 46b to amplify the DC signal if needed. As shown in the figure, the sensor assembly 40 also includes a signal conditioning unit 45, which includes an amplifier 45a and signal filter-regulator 45b. The signal conditioning unit 45 conditions the urine signal embedded with urine data captured from the sensing module 42 and converts the signal to data to be processed in the processor 41 so that it is ready for transmission to an external computing device 2.

[0063] Optionally, analyzing device 30 may be provided with a sealing element like drainage member 10 that forms a liquid-tight seal to the sensor assembly 40 subassemblies. As exemplified, the sensor assembly 40 is sealed by being overlaid with the sealing element so that the circuitry provided thereon may be protected from a hydrophilic coating, lubricant applied to the catheter, and / or being wetted by the urine flow. Optionally, the sealing element may be UV-curable epoxy resin.

[0064] (II) Power Unit and User Interface

[0065] Fig. 5B illustrates a schematic block diagram of an exemplary sensor assembly 140 and at least one sensing module 142 included in the urine analyzing device 30 featured with a rechargeable power supply. In this exemplary subassembly 140, the circuitry may be printed or fabricated on a flexible substrate made from materials such as paper, polyamide, PET, or the like that resides in indentation 36. The subassembly 140 may include processor 141 , such as MCU, and active components connected thereto, including but not limited to memory 116 (optional), atAttorney Docket No. 3400-0376.01 (837PCT)least one sensing module 142, transceiver / communication module 143, signal conditioning unit 145, and a power unit 146. In this embodiment, subassembly 140 comprises a circuitry with a receiving interface having at least one input port and a transmitting interface having at least one output port communicating with the user. The at least one input port is configured to receive input from the at least one sensing module 142 and the user through mobile APP on the external computing device 2. On the other hand, the at least one output port is configured to transmit output to the user. As exemplified, the receiving interface is provided with a power unit 146 embedded with a charging circuitry (not shown) for charging and / or powering the device 30 and active components thereof. For example, the charging circuitry is connected to a built-in battery 146a, a power switch 144, a charging terminal 149, a fuse (not shown), and the processor 141. In an exemplary embodiment, the charging circuitry is hardwired, connecting to the charging terminal 149 or communication port (not shown) disposed on the receiving interface for wired charging the battery. The charging terminal 149 may be a terminal port available in the industry, such as C-type USB. Optionally, the power terminal 149 may also be a communication port that acts as a connection to an external power source or wired communication channel. In one embodiment, processor 141 acquires the status information of the battery, and based on the battery status information, processor 141 controls a user interface 148, such as a visual indicator. For example, an LED that blinks at a specific preprogrammed frequency to alert the user that the device is in low power and charging of the battery is required. The active components affixed to the power unit 46, as well as the power unit 46 itself, as illustrated in Fig. 4 — i.e., processor 41 , sensor / sensing module 42, transceiver / communication module 43, amplifier 45a, signal filter-regulator 45b included in signal conditioning unit 45, described herein are correspondingly referenced in Fig. 5B by adding the numeral ‘100’.

[0066] The active components affixed to the sensor assembly 20, 40 and subassembly 120, 140 may be arranged in a waterproof design, allowing the urinary fluid to contact the sensing modules 22, 44 to produce a sensing signal without exposing other active components to moisture as the fluid flows through the channel / conduit 13c, 31 during catheterization.

[0067] Optionally, the mobile app may include an algorithm to transmit the mapped information and / or urine data to the healthcare network to verify the user’s (patient’s) profile and process and store the information. The uniqueness of mapping of FID withAttorney Docket No. 3400-0376.01 (837PCT)UID inherent from the unique nature of both PID and UID ensures integrity and uniqueness of the catheter being used, and ultimately, the uniqueness of mapping PID and UID, to avoid conflicting data or overwriting data unnecessarily. The PID mapped with the UID may be saved and logged in the healthcare system via the mobile app.

[0068] Optionally, data collected by computing device 2 can be integrated with other systems, such as healthcare systems equipped with applications to perform data analysis and provide real-time visibility for healthcare providers. This allows healthcare providers to recognize any potential bladder health issues indicated by the urinary data, enabling the treatment regimen to be revisited and adjusted based on the nature of the health issue uncovered through data analysis.

[0069] The person having such an external computing device 2 and whose catheterization is being managed or monitored is referred to as the user, but it should be understood that the device might be used unchanged in situations where the person catheterizing, the person monitoring, and the person evaluating feedback need not all be the same person. It will be understood that the drainage member 10 and urine analyzing device 30 and the system associated with the drainage member 10 and the urine analyzing device 30 may be used to generally track bladder health based on the urinary data.

[0070] These are the exemplary input / output (I / O) communication ports employed in drainage member 10 and urine analyzing device 30 of the present disclosure. Depending on the nature of the bladder health management designed for a subject, and the principles described herein, the drainage member 10 and the urine analyzing device 30 and / or external powering device 27 may be employed with other I / O communication ports without departing from the scope of the present disclosure.

[0071] Other Active Components

[0072] (A) Processor and its peripheral components

[0073] Processors 121 , 141 include the hardware and the firmware that, with the support of program memory and random-access memory (RAM) communicates with one or more sensors / sensing modules, receives the sensor data, processes the sensor data, stores the processed data in memory, communicates with a transmitter or directly to the database server system via the computing device 2, and manages the power source 126, 146. Memory 116 may store the processed data until successful transmission of the data to the external computing device 2 is confirmed.Attorney Docket No. 3400-0376.01 (837PCT)

[0074] Other devices, systems, or means for connection / communication between drainage member 10, analyzing device 30, and other devices or computers are also possible. For example, drainage member 10 and analyzing device 30 may include a wireless transmitter or transceiver (e.g., Zigbee, etc.) to transmit data wirelessly. In one embodiment, short-range radiofrequency (RF) principles may be used. Some short-range RF protocols that can be used are referred to as “Bluetooth.” Wireless 802.11 communication principles and / or similar communication principles may also be used. Smart drainage member / device 10, 30 or the computing device 2 with which the smart drainage member / device 10, 30 communicates may optionally be connected to a network (e.g., the internet or a local network), and the data may be shared with and / or processed by other devices or computers connected to the network.

[0075] For example, the external computing device 2 is equipped with an algorithm such as a mobile app to convert the monitor data to meaningful information, for example, process the color sensor data to determine the hydration level, nitrites, leucocytes, pH or other urine analytes of the subject while the urine is discharged for each catheterization event, reprocess the data, store the data, retrieve analyzed data, and / or generating reports. In other examples, the above-said data and / or information are transmitted to the server. In another example, the transceiver module 123, 143 transmits raw data to a cloud network and / or server or another device. In another example, the transceiver module 123, 143 transmits filtered data to a server or other device.

[0076] Additionally, it should be noted that various methods and operations are described as being executed by the sensing module 122, 142 and processor 121 , 141 in drainage member / device 10, 30 primarily digitizing analog signal and processing the digitized data to a format which is ready to be transmitted to external computing device 2. Other executions, such as user applications, may be executed in full or in part in the computing device processing element or other processing elements associated with the healthcare provider device. Discussions of a particular processing element are meant as illustrative only.

[0077] (B) Sensors

[0078] The at least one sensing modules 122, 142 are connected to the processors 121 , 141. The sensing module(s) is optionally integrated into an in-stream sensorAttorney Docket No. 3400-0376.01 (837PCT)block, including, but not limited to, a pressure sensor, a force sensor, and / or any sensor detecting urine analytes.

[0079] (C) Communications interfacing within the system

[0080] In an exemplified arrangement, for the purpose of establishing effective communication between the user (or environment) and the drainage member / device 10, 30, the subassembly 120, 140 may include a processor 121 , 141, and one or more interfaces, and at least two interfaces termed as a first interface (appliance interface) and a second interface (transmission interface). The first interface is configured as an appliance interfacing structure which provides an input channel to capture the urinary data and power. The second interface is configured as a transmission interfacing structure which provides an output channel establishing communication between the drainage member / device 10, 30 and the external computing device 2 within the system 1. The first interface includes the at least one sensing module 122, 142 and power unit 126, 146, whereas the second interface includes the transceiver / communication module 123, 143.

[0081] Referring to Figs. 5A and 5B, processors 121, 141 are in communication with the color sensors 122a, 142a to determine the color of the urinary fluid conveyed from the catheter. The memory 116 is used to save color data during use. It is an option that the memory internal to processors 121 , 141 can store data other than pressure and force depending on additional sensors necessary for additional parametric measurements, such as pressure, force, and temperature of the urinary fluid.

[0082] In the exemplary drainage member / device 10, 30, the processor 121, 141 is further configured to control the power unit 126, 146 powering up the smart drainage member / device 10, 30, upon receiving RF signal from the external device 27 (in drainage member 10) or power switch 144 being turned ON (in smart urinary analyzing device 30). In this exemplary drainage member / device, only the case where the RF signal from the external device 27 is described. However, it should be appreciated that the configuration is equally applicable to other triggering mechanisms in energizing the smart drainage member / device 10, 30. The drainage member 10, when not in use, is configured in a low-power mode or idle mode to conserve energy. Upon receiving the RF power signal from external device 27, processor 121 is configured to control power unit 126 to power up the drainage member / device 10, 30. Processor 121 is further configured to receive the pressure and / or force signals fromAttorney Docket No. 3400-0376.01 (837PCT)the pressure and force sensors, respectively. The processor 121 is programmed to convert the sensing signal to data. The processor 121 sends the monitor data MD_1 to the transceiver module 123. The transceiver module 123 in communication with the processor 121 is configured to receive the monitor data MD_1 and establish a connection between the smart drainage member 10 and the computing device 2 upon receiving instruction from the computing device 2 via mobile APP (assume mobile APP is activated). While it is an option that the monitor data can be converted to transmission signal within a controlling unit within the transceiver 123, for simplicity of the design, described herein is the processor 121 being configured to generate an output signal embedded with the monitor data to be transmitted via the transceiver 123. In an exemplary drainage member 10, the transmission between drainage member 10 and computing device 2 is unidirectional from drainage member 10 to computing device 2. The transmission signal (also the output signal generated from the processor 121 ) embedded with the monitor data MD_1 (at this point, the wireless communication port in computing device 2 is assumed opened) will be transmitted via the antenna 123a. The transmission signal is a short-range radiofrequency (RF) protocol described above. In the exemplary embodiments, RF “Bluetooth” is used as the communication protocol between drainage member 10 and computing device 2.

[0083] Processor 121 is optionally configured to, in accordance with a determination that the connection is not successfully established, abort the transmission of monitor data MD to the computing device 2.

[0084] The drainage member 10 is optionally configured to, in accordance with a determination that the connection fails to establish, the processor 121 is configured to abort transmitting the monitor data MD to the computing device 2 and establish another connection to the computing device 2 after a predefined connecting time window. The processor 121 may abort transmitting the monitor data MD to the computing device 121 after a predefined timeout is reached. Processor 121 may be configured to reestablish another connection to computing device 2 within another connecting time window. The cycle may be repeated until the connection is successfully established. In other words, the system handles wireless connection timeout by aborting the current connection and reestablishing it to ensure data integrity during transmission.

[0085] Drainage member 10 or the computing device 2 with which the drainage member 10 communicates may optionally be connected to a network (e.g., theAttorney Docket No. 3400-0376.01 (837PCT)internet or a local network), and the data may be shared with and / or processed by other devices or computers connected to the network which is accessible at the healthcare provider end.

[0086] Fig. 6 is a block diagram illustrating an exemplary external computing device 600 (2) according to the present disclosure. The computing device 600 forms part of a catheter-associated urinary tract health monitoring system and can support the monitoring of the operating state of the drainage member to be used by a user. The computing device 600 comprises a memory 601 ; a processor 602 coupled to the memory 601 ; and an interface 603, coupled to the processor 602.

[0087] Peripheral devices, such as memory 601 and / or interface 603 can be operatively and communicably coupled to the processor 602 via a bus for communicating data. The processor 602 can be a central processing unit (CPU), but other suitable microprocessors are also contemplated.

[0088] The interface 603 is configured to communicate with the catheter 10 of the system 1. The interface 603 may comprise a display 603B as a visual interface to the user. The interface 603 is configured to establish a connection between the drainage member 10 and the computing device 2. The interface 603 is configured to receive monitor data MD from the smart drainage member 10. Optionally, the interface 603 is configured to establish an accessory connection between the computing device 2 and the healthcare provide network via activating the associated mobile APP.

[0089] The computing device 600 / processor 602 is configured to determine whether the connection is established; and in accordance with a determination that the connection is not established, abort to receive the monitor data MD from the smart drainage member 10.

[0090] The data transmitted to the computing device 2, and / or server may be used to record the urinary tract health of the user and / or warn the user of changes or risks with their urinary tract health. For example, computing device 2 may have software (i.e mobile APP) that analyzes the data and provides notifications when certain parameters are detected. Furthermore, these notifications may be provided to a healthcare provider via a connection to server. Additionally, the urine data may be achieved by the computing devices or server for a healthcare provider to review.

[0091] In the foregoing specification, specific embodiments have been described. However, one of ordinary skills in the art appreciates that various modifications and changes can be made without departing from the scope of the invention as set forthAttorney Docket No. 3400-0376.01 (837PCT)in the claims below. Accordingly, the specification and figures are to be regarded in an illustrative rather than a restrictive sense, and all such modifications are intended to be included within the scope of present teachings.

Claims

Attorney Docket No. 3400-0376.01 (837PCT)CLAIMS1 . A drainage member for use with a urinary catheter having a coupling end to connect with the drainage member, comprising:a housing having a housing wall with an indentation therein, the housing having a distal end including an outlet opening and a proximal end including an inlet opening , the outlet opening and inlet opening being in fluid communication with a channel extending within the drainage member , wherein the drainage member is configured to be connected to the catheter in a manner wherein the channel of the drainage member and a catheter lumen of the catheter are in a cascaded arrangement such that the channel and the catheter lumen are aligned to form a mutual passage;a sensor assembly comprising circuitry connected to at least one sensing module, wherein the sensor assembly further comprises a power unit for powering up the circuitry; andwherein the sensing assembly and at least one sensing module are in the indentation of the housing wall and the at least one sending module is configured to sense at least one characteristic of the urine and / or urinary tract and to produce a signal associated with the at least one characteristic.

2. The drainage member according to claim 1 , further comprising a test pad located in the drainage member channel.

3. The drainage member according to claim 1 , further comprising a locking mechanism configured for holding the urinary catheter to the drainage member, the locking mechanism including a receptacle at the proximal end of the housing, the receptable being configured to engage with a latching element at the coupling end of the urinary catheter.

4. The drainage member according to claim 1 , wherein the power unit comprises a receiver coil and is activated by an external transmitter.

5. The drainage member according to claim 4, wherein the external transmitter comprises a transmitter coil, a transmitter power supply and an oscillator circuit, andAttorney Docket No. 3400-0376.01 (837PCT)wherein the external transmitter transfers power from the transmitter coil to the receiver coil through induction coupling.

6. The drainage member according to claim 1 , wherein the circuitry connects to the at least one sensing module by a wiring connection.

7. The drainage member according to claim 6, wherein the wiring connection is an ink printed wire.

8. The drainage member according to claim 7, wherein the sensor assembly and / or wiring connection is sealed, at least in part by a sealing element.

9. The drainage member according to claim 8, wherein the sealing element is UV-curable resin.

10. The drainage member according to claim 1 , wherein the at least one sensing module is a colorimeter.

11. The drainage member according claim 1 , wherein the sensor assembly comprises a flexible substrate further comprising at least one input port, at least one output port, a processor and a transceiver module arranged on the flexible substrate.

12. The drainage member according to claim 11 , wherein the at least one input port interfaces with the at least one sensing module for receiving signal associated with the at least one characteristic of the urine and the power unit for receiving power from the external transmitter.

13. The drainage member according to claim 11 , wherein the at least one output port interfaces with the transceiver module for establishing wireless connection with a computing device.

14. An external analyzing device for use with a drainage member associated with a urinary catheter, comprising:Attorney Docket No. 3400-0376.01 (837PCT)a housing having a wall with an indentation therein, the housing having a distal end with an outlet opening and a proximal end with an inlet opening, the outlet opening and the inlet opening being in fluid communication with a conduit extending within the analyzing device, wherein the analyzing device is configured to connect with the drainage member having a channel extending therein, the conduit, channel and catheter lumen of the catheter being in a cascaded arrangement such that the conduit, channel and the catheter lumen are aligned to form a mutual passage; a sensor assembly comprising circuitry connected to at least one sensing module, wherein the sensor assembly further comprises a power unit having a battery for powering up the circuitry; andwherein the sensor assembly and at least one sensing module are arranged in the indentation, the at least one sensing module configured to sense at least one characteristic of the urine and / or urinary tract, the at least one sensing module being configured to produce a signal associated with the at least one characteristic.

15. The external analyzing device according to claim 14 further comprising a test pad located in the analyzing device conduit.

16. The external analyzing device according to claim 14, wherein the proximal end of the housing comprising a coupling interface configured for releasably couple the analyzing device with the drainage member or de-couple the analyzing device from the drainage member.

17. The external analyzing device according to claim 14, wherein the battery is rechargeable and the external device further comprising a charging terminal for charging the battery to supply power to the external device.

18. The external analyzing device according to claim 14, wherein the sensor assembly is sealed, at least in part by a sealing element.

19. The external analyzing device according to claim 18, wherein the sealing element is UV curable resin.Attorney Docket No. 3400-0376.01 (837PCT)20. The external analyzing device according to claim18, wherein the at least one sensing module is a colorimeter.

21. The external device according claim 14, wherein the sensor assembly is a flexible substrate further comprising at least one input port, at least one output port, a processor and a transceiver module arranged on the circuitry.

22. The external device according to claim 21 , wherein the at least one input port interfaces with the at least one sensing module for receiving signal associated with the at least one characteristic of the urine and the power unit for receiving power from the external transmitter.

23. The external device according to claim 21 , wherein the at least one output port interfaces with the transceiver module for establishing wireless connection with a computing device.

24. A system for analyzing urine flowing from a urinary catheter, comprising: the catheter and a drainage member associated with the catheter,wherein the drainage member comprising:a housing having a housing wall with an indentation therein, the housing having a distal end including an outlet opening and a proximal end including an inlet opening, the outlet opening and inlet opening being in fluid communication with a channel extending within the drainage member; wherein the drainage member is configured to be connected to the catheter in a manner wherein the channel of the drainage member and a catheter lumen of the catheter are in a cascaded arrangement such that the channel and the catheter lumen are aligned to form a mutual passage;a sensor assembly comprising circuitry connected to at least one sensing module, wherein the sensor assembly further comprises a power unit for powering up the circuitry; andwherein the sensing assembly and at least one sensing module are in the indentation of the housing wall and the at least one sensing module is configured to sense at least one characteristic of the urine and / or urinaryAttorney Docket No. 3400-0376.01 (837PCT)tract and to produce a signal associated with the at least one characteristic; andthe system further comprises an external transmitter comprising:transmitter coil, a transmitter power supply and an oscillator circuit; wherein the external transmitter transfers power to the power unit through electromagnetic induction.

25. The drainage member according to claim 1 , further comprising a test pad located in the drainage member channel.

26. A system for analyzing urine flowing from a urinary catheter, comprising: an external analyzing device, the catheter, a drainage member associated with the catheter; wherein the external analyzing device comprising:a housing having a wall with an indentation therein, the housing having a distal end with an outlet opening and a proximal end with an inlet opening, the outlet opening and the inlet opening being in fluid communication with a conduit extending within the external analyzing device; wherein the external analyzing device is configured to connect with the drainage member having a channel extending therein the conduit, channel and catheter lumen of the catheter being in a cascaded arrangement such that the conduit, channel and the catheter lumen are aligned to form a mutual passage;a sensor assembly comprising circuitry connected to at least one sensing module, wherein the sensor assembly further comprises a power unit for powering up the circuitry; andwherein the sensor assembly and the at least one sensing module are arranged in the indentation, the at least one sensing module configured to sense at least one characteristic of the urine and / or urinary tract, the at least one sensing module being configured to produce a signal associated with the at least one characteristic; andthe system further comprises an external transmitter comprising:a transmitter coil, a transmitter power supply and an oscillator circuit; wherein the external transmitter transfers power to the power unit through electromagnetic induction.Attorney Docket No. 3400-0376.01 (837PCT)27. The system according to claim 26, wherein the external analyzing device further comprising a test pad located in the analyzing device conduit.

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