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

Abstract

A smart catheter for monitoring catheter-associated urinary tract health and a system thereof are disclosed. The catheter 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 catheter, an external transmitting device and a computing device. Another smart catheter provides a sensor assembly energized by urine activated power. The system includes the another smart catheter 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. 3400-0365.02 (834PCT)System For Analyzing Urine Flowing From An Intermittent Urinary Catheter And / Or Monitoring Catheter-Associated Urinary Tract HealthField 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” 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. In addition, discomfort from intermittent catheterization, for example, when the users insert the catheter to the urethra, may discourage users from adhering to their catheterization regimen, leading to non-compliance.

[0003] In the currently available art, a portable monitoring device external to the urinary catheter may be used to engage with the urinary catheter to collect urinary data necessary for tracking catheterization history and intervene if there were signs of non-compliance. Often, the user forgets to bring such portable devices, which disrupts consistent health monitoring, leading to data gaps, suboptimal treatment, increased health risks, and overall poorer patient outcomes. Thus, there remains a need for “smart” catheters with capabilities that could help users insert the catheter correctly, and a way to power “smart catheters.”Attorney Docket No. 3400-0365.02 (834PCT)Summary

[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 of such aspects separately or in different combinations as set forth in the claims appended hereto.

[0005] In one aspect, a urinary catheter, comprises a) a flexible catheter tube having a tube wall with an indentation therein; the flexible catheter tube having a distal end leading to an outlet and a proximal end with one or more openings in fluid communication an internal lumen extending within the catheter tube and allowing for urine to flow therethrough; b) a sensor assembly comprising a circuitry wiredly connected to at least one sensing module, wherein the sensor assembly further comprises a power unit for powering up the circuitry; and wherein the indentation is sized for accommodating at least the sensor assembly therein and wherein the at least one sensing module is associated with the tube wall and senses 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.

[0006] In another aspect, a urinary catheter, comprises a) a flexible catheter tube having a tube wall, a distal end leading to an outlet and a proximal end with one or more openings opposite to the distal end leading to an internal lumen that within the flexible catheter tube and allows for urine flowing therethrough; b) a sensor assembly comprising a circuitry wiredly connected to at least one sensing module and a power unit for powering up the circuitry and the at least one sensing module associated with the circuitry, wherein the at least one sensing module associated with the tube wall and sensing at least one characteristic of the urine and / or the urinary tract, the at least one sensing unit being configured to produce signal associated with the at least one characteristic; and wherein the sensor assembly, the at least one sensing module and the power unit are positionedAttorney Docket No. 3400-0365.02 (834PCT) inside of the tube wall, and wherein the power unit is exposed to the urine flowing through the internal lumen to generate power.

[0007] In another aspect, a system for analyzing urine flowing from a urinary catheter, comprises the urinary catheter comprising a) a flexible catheter tube having a tube wall with an indentation therein, the flexible catheter tube having a distal end leading to an outlet and a proximal end with one or more openings opposite to the distal end leading to an internal lumen that extends within the flexible catheter tube and allows for urine flowing therethrough; b) a sensor assembly comprising a circuitry wiredly connected to at least one sensing module, wherein the sensor assembly further comprises a power unit for powering up the circuitry and the at least one sensing module associated with the circuitry; wherein the indentation is sized for accommodating at least the sensor assembly therein and wherein the at least one sensing module is located on the tube wall and sensing at least one characteristic of the urine and / or the urinary tract, the at least one sensing module being configured to produce signal associated with the at least one characteristic; and 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, comprises the urinary catheter comprising: a) a flexible catheter tube having a tube wall, a distal end leading to an outlet and a proximal end with one or more openings opposite to the distal end leading to an internal lumen that extends within the flexible catheter tube and allows for urine flowing therethrough; b) a sensor assembly comprising a circuitry wiredly connected to the at least one sensing module and a power unit for powering up the circuitry and the at least one sensing module associated with the circuitry; wherein the at least one sensing module is associated with the tube wall and sensing at least one characteristic to the urine and / or the urinary tract, the at least on sensing module is configured to produce signal associated with the at least one characteristic, wherein the sensor assembly further comprising a transceiver module for establishing wireless connection with a computing device; and wherein the sensor assembly, the at least one sensing module and the power unit are located on the inside of the tubeAttorney Docket No. 3400-0365.02 (834PCT) wall; and wherein the power unit exposed to the urine to generate power; and the computing device is configured to wireless communicate with the urinary catheter in receiving the at least one characteristic of the urine for analysis.Brief Description of the Drawings

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

[0010] Fig. 2A is a perspective view of an exemplary smart catheter.

[0011] Fig. 2B is an enlarged perspective view of an exemplary segment of a catheter tube with an indentation.

[0012] Fig. 2C is a perspective view of an exemplary circuit of a sensor assembly.

[0013] Fig. 2D is a detailed view of a portion of one exemplary assembly of a smart catheter showing a circuitry subassembly connected to one embodiment of a power source.

[0014] Fig. 2E is a top view of the exemplary assembly of the smart catheter of Fig. 2D showing the circuitry subassembly connected to the power source.

[0015] Fig. 2F is a schematic block diagram of an exemplary circuit employed in the power source.

[0016] Fig. 3 is a partial perspective, cross-sectional view of another exemplary smart catheter with a circuitry subassembly connected to a second embodiment of a power source.

[0017] Fig. 4 is a perspective view of an exemplary circuit assembly of the second embodiment of the power source employed in another exemplary smart catheter.

[0018] Fig. 5A is a schematic block diagram of an exemplary circuitry included in a smart catheter having the first embodiment of the power source.

[0019] Fig. 5B is a schematic block diagram of an exemplary circuitry included in a smart catheter having the second embodiment of the power source.

[0020] Fig. 6 is a block diagram illustrating an exemplary external computing device.Attorney Docket No. 3400-0365.02 (834PCT)Description of the Illustrated Embodiments

[0021] 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.

[0022] The present application provides a “smart” urinary catheter that 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 (i) Transcutaneous Energy Transfer (TET) systems, or (II) a urine activated battery. The sensory 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.

[0023] 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 .

[0024] Fig. 1 illustrates an exemplary urine analyzing system and / or catheter- associated urinary tract health monitoring system 1 , which includes a smart urinary catheter 10 and, optionally, a portable computing device 2 (mobile phone, smartphone, tablet, watch, or any other suitable portable computing device). Urinary catheter 10 may be an intermittent urinary catheter, which may be a disposable single-use catheter or a reusable multiple-use catheter.

[0025] In one embodiment, the smart catheter 10 houses circuitry interfacing with a wireless external powering device 4. 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 theAttorney Docket No. 3400-0365.02 (834PCT) 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 the catheter 10 wirelessly receives power from the external device 27 at a receiving interface via inductive coupling.

[0026] In another embodiment of an exemplary catheter, the circuitry interfaces the urine flow at a first interface (a receiving interface) configured to provide an input channel to capture urinary data and power from urine flowing in the urinary catheter 10. In all embodiment disclosed herein, 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 smart catheter 10 and the external computing device 2 within the monitoring system 1 .

[0027] In the exemplified smart catheter 10 as illustrated in Fig. 2A, the catheter is configured to wirelessly communicate with the portable computing device 2. Optionally, the computing device 2 is configured to communicate with a server of the health monitoring system e.g., via network such as 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 in the shown urinary tract health monitoring system) or parametric data based on the appliance data (urinary data in the shown health monitoring system) are obtained from a sensing module(s) assembly included in and / or operatively connected to the circuitry housed in the smart catheter 10. The catheter 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 the computing device 2 for storage and / or analysis. In the illustrated catheter- associated urinary tract health monitoring system 1 , the computing device 2 is a mobile phone, however the 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, the smart catheter 10 is configured to collect urinary data and transmit the data to the portable computing device 2.

[0028] Fig. 2A is an illustration of a smart catheter 10. As shown in the figure,Attorney Docket No. 3400-0365.02 (834PCT) the intermittent urinary catheter 10 comprises a flexible a catheter tube 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, smart catheter 10 may have a rounded proximal tip 17 that may be lubricated and inserted into the urethra, wherein the user advances the catheter tube 12 until the proximal tip 17 enters the bladder. Urine then flows into one or more openings or eyelets 19 adjacent to and or in the proximal tip 17 and proximally through the lumen / conduit 18 of the catheter tube 12. The distal end 15 of catheter tube 12 defines an outlet in fluid communication with a catheter drainage member 13, such as a funnel or port, associated with distal end 15. The user may hold the distal end 15 of the catheter tube 12 and / or drainage member 13 to direct urine drainage into a toilet. In an alternative embodiment, the drainage member 13 may be sealed within a collection bag (not shown).

[0029] Catheter tube 12, and therefore smart catheter 10, includes a tube wall 14 having an indentation 16. The indentation 16 may be formed when the catheter tube is being shaped or may be carved out of an already formed catheter tube. For example, indentation 16 may be cut or carved out of the catheter wall’s outer surface adjacent to the proximal tip 17. The carving of indentation 16 may be performed via laser cutting, lithography, or any other suitable cutting method. In another alternative, when the catheter tube 12 is made by injection molding, indentation 16 is formed during the molding process.

[0030] Now turning to sensor assembly 20, subassembly, and the at least one sensing module 22 as illustrated in Fig. 2C, the 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 modules), a power unit 26, a signal conditioning unit 25 and / or transceiver / communication module 23. The at least one sensing module 22 of an exemplary catheter 10 as illustrated in Fig. 1 may include pressure sensor 22a, force sensor 22b, motion sensors such as gyroscopic senor 22c and accelerometer 22d or any 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.Attorney Docket No. 3400-0365.02 (834PCT)

[0031] In Fig. 2C, sensor assembly 20 and its subassembly may be wiredly connected with the at least one sensing module 22 via wiring connection 24. The sensor assembly 20, the at least one sensing module 22, and the wiring connection 24 therebetween may be located in the indentation 16. Specifically, in an exemplary catheter as illustrated in Figs. 2B, 2D and 2E, indentation 16 may be sized and shaped into three sections, denoted as 16a-16c, to complementarily accommodate the sensor assembly 20, wiring connection 24, and sensing module 22, respectively. The wiring connection 24 may be stranded wire, solid wire, or as exemplified in the present disclosure, printed wire printed by, for example, black carbon ink. In another embodiment as illustrated in Fig. 3 (urine energized power option), the sensor assembly 40 along with a urine activated power unit 46 may be located inside a lumen or conduit 38 of a catheter tube 32, such as adjacent to eyelets 39, which will be discussed in more detail below. Sensor assembly 20 may be affixed in indentation 16 by any suitable manner. For example, sensor assembly 20 may be held by friction fit, snap fit, melting of the catheter tube, or adhesive.

[0032] Optionally, as illustrated in Fig. 2D and 2E, catheter 10 is provided with a sealing element 28 that forms a liquid-tight seal to the sensor assembly 20 subassembly. As exemplified, the sensor assembly 20, subassembly, and wiring connection 24 are at least partly 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.

[0033] Active Components on the Subassembly

[0034] (A) Power Unit - Inductive Coupling Power

[0035] According to an embodiment of a first alternative power option of inductive coupling, as illustrated in Fig. 2C, 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 the smart catheter 12 indwelling inside the user’s body, such as bladder, captures the magnetic field generated by an external power device 27 (Fig. 1 ), which may be an external transmitter.Attorney Docket No. 3400-0365.02 (834PCT)

[0036] Turning to the active components included in the external power device 27 as illustrated in Figs. 1 and 2F, 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, a power option of inductive coupling may be used to power up the smart catheter 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. 2F, the external transmitter 27 having primary coil 27a is placed on or near the skin and is 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, for example RF energy, induced by the oscillator circuit 27c passes through the primary / transmitter coil 27a and generates 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 required 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 catheter 10 through electromagnetic induction. The another AC induced in the receiver coil 26a is then rectified and regulated by the associated sensing circuit which includes rectifier, filter, and regulator, collectively denoted as 26b, to provide the direct current (DC) power required for energizing the components in the smart catheter 10. Optionally a DC-DC booster or amplifier 26c may be annexed to the sensing circuit 26b to amplify the DC signal if needed.

[0037] (B) Power Unit - Urine Activated Power

[0038] According to another embodiment of the smart catheter having a second alternative power design, a urine activated cell is used as illustrated in Figs. 3 and 4. In this embodiment, the power unit 26 may include a urine activated battery or urine microfluidic cell 46, such as pPAD. The urine activatedAttorney Docket No. 3400-0365.02 (834PCT) cell is a small microfluidic chip comprising a substrate made from flexible material, such as paper, polydimethyl siloxane (PDMS), polymethyl methacrylate (PMMA) or polyamide (PA) doped with electrolytes such as an alkali. The cell is fabricated via either wax printing, screen printing or lithography. Similar to the wire connection as exemplified in the inductive power option, the at least one sensing module 42a-42d may be wiredly connected to the sensor assembly 40 with printed wire 44. The same printed wire 44 may also be used to connect the urine microfluidic cell 46 to the sensor assembly 40 as shown in Fig. 3. Fig. 4 illustrates an exemplified urine microfluidic cell 46 which consists of cell body 46a, electrodes, i.e. , anode 46b and cathode 46c, and a urine flow channel 46d. The electrodes 46b, 46c are disposed on the sides of the flow channel 46d. The anode 46b is typically coated with microorganisms or enzymes that catalyze the oxidation of urine components, whereas the cathode 46c is positioned to receive electrons from the external circuit, often coated with materials that facilitate reduction reactions. Urine itself acts as the electrolyte, providing ions and organic compounds necessary for the redox biochemical reactions. When urine flows through the urine channel 46d and the cell body 46a, it induces charges on the electrodes 46b, 46c. Ions in the urine move through the microfluidic channels or paper substrate (i.e. urine channel 46d and cell body 46a), balancing the charge as electrons flow through the external circuit (i.e. the sensor assembly 40 and the at least one sensing module 42a-42d). Specifically, oxidation takes place in the anode 46b on which the microorganisms or enzymes catalyze the oxidation of organic compounds in urine. This process releases electrons and protons and thereby flow through the external circuit to the cathode 46c. At cathode 46c, these electrons participate in reduction reactions, typically combining with protons and oxygen to form water or other products.

[0039] The difference in electrochemical potential between anode 46b and cathode 46c creates a voltage, or potential difference, across the electrodes. This potential difference drives the flow of electrons through the external circuit, generating electric current, which can be harvested and used to power up the smart catheter 10 of the present disclosure.

[0040] Urine microfluidic cells harness the chemical energy in urine to produceAttorney Docket No. 3400-0365.02 (834PCT) electrical energy through electrochemical reaction, microbial metabolism, and similar processes. This bioelectricity can then be used to power low-energy medical devices, offering a sustainable and self-sufficient energy solution. In addition, the materials such as paper, ink printed material used in fabricating the sensor assembly substrate are significantly cheaper than traditional materials used in microfluidics, such as glass, silicon, or polymers. The “smart” catheter as disclosed herein is a single-use catheter with an integrated sensor assembly which may be made from degradable materials, ensuring compliance with universal disposal standards.

[0041] In both inductive power and urine activated power options, active components affixed to the sensor assembly and subassembly may be arranged in a waterproof design, allowing the urinary fluid to contact the sensing modules 22, 42 to produce a sensing signal without exposing other active components to moisture as the fluid flows through the conduits 18, 38 during catheterization.

[0042] (C) Sensor assembly-sensing module subassembly

[0043] Fig. 5A illustrates a schematic block diagram of an exemplary subassembly 120 of sensor assembly and sensing module included in the smart catheter 10 featured with 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 16. 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 (inducive 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, inductive coupling (such as RF coupler) power unit 126 that wirelessly tunes with an external transmitter (Figs.1 and 2F) equipped with an RF energy transmitting circuit when the externalAttorney Docket No. 3400-0365.02 (834PCT) 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 smart catheter 10 via TET. In an exemplified catheter 10, the TET may be RF coupler or any other like Tuned Energy Transfer. At the time of use, the user switches ON the external transmitter and thereby wirelessly pairs the external transmitter with the smart catheter 10 to enable energy transfer from the transmitter to the catheter. The components affixed to the inductive power unit, as illustrated in Figs. 2C and 2F — i.e., receiver coil 26a, rectif ier / f ilter / regulator (sensing circuit) 26b, and DC-DC amplifier 26c — are correspondingly referenced in Fig. 5A by adding the numeral ‘100’. Details of the general principle of TET technology or energy transfer via inductive coupling have been described in the above and will not be reiterated here to conserve page size.

[0044] In this exemplary catheter 10, the at least one input port(s) may connect to the at least one sensing module 122 such as pressure sensor 122a as exemplified and optionally force sensor 122b (corresponding to sensors, 22a and 22b of Fig. 1 ). In another exemplified catheter 10, the at least one sensing module 122, optionally, may include gyroscope 122c and accelerometer 122d (corresponding to 22c and 22d in Fig. 1). The sensors 122a-122d generate sensed signal characterizing the urine fluid which is sent to signal conditioning unit 125 for conditioning. The conditioned signal is then sent to processor 121 for processing and converting to a format compatible with the communication protocol / bus running between the 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, converts the signal to data to be processed in the processor 121 ready for transmitting to an external computing device 2 (Fig. 1). The data may also include identification information associated with the catheter 10 (denoted as CID) which is pre-programmed in the processor 121 during a specific configuration or calibration stage. Alternatively, CID may be stored in non-volatile memory within the MCU, such as EEPROM, flash memory,Attorney Docket No. 3400-0365.02 (834PCT) or the like. In another embodiment, the CID may further include embedded information, such as product details, manufacturing date and 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 CID pre-programmed in processor 121 of smart catheter 10.

[0045] Optionally, the mobile application (mobile APP) may be programmed to retrieve the CID from the catheter 12 after pairing the computing device 2 with the catheter 10. The mobile APP may also include mapping the identification information associated with the catheter (CID) 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.

[0046] 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 the catheter 10 to the computing device 2, connection between the catheter 10 and the 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 catheter 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 the 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.

[0047] Fig. 5B illustrates a schematic block diagram of another exemplary subassembly 140 of sensor assembly and sensing module included in the smartAttorney Docket No. 3400-0365.02 (834PCT) catheter 30 featured with urine activated 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 on the inside of the catheter 10. The subassembly 140 may include processor 141 , such as MCU, and active components connected thereto including but not limited to memory 116 (optional), at least one sensing module 142, transceiver / communication module 143 and a (urine activated) power unit 146. In this embodiment, the sensor assembly 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 user and power from the urine activated power supply. 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, urine activated microfluidic cell power unit 146 and the at least one sensing module 142. At the time of use, the catheter 30 is energized by the urinary flow during catheterization. Details of the general principle of urine activated power design have been described in the above and will not be reiterated here to conserve page size. The components affixed to the urine activated microfluidic cell power unit, as illustrated in Fig. 4 — i.e., cell body 46a, anode 46b, cathode 46c and urine flow channel 46d — are correspondingly referenced in Fig. 5B by adding the numeral ‘100’. Details of the general principle of urine activated power design have been described in the above and will not be reiterated here to conserve page size.

[0048] In this exemplary catheter 30, the at least one input port(s) may connect to the at least one sensing module 142 such as pressure sensor 142a as exemplified and optionally force sensor 142b (corresponding to 42a and 42b in Fig. 3). In another exemplified catheter 30, the at least one sensing module 142, optionally, may include gyroscope 142c and accelerometer 142d (corresponding to 42c and 42d in Fig. 3). The sensors 142a-142d generate sensed signal characterizing the urine fluid which is sent to signal conditioning unit 145 for conditioning. The conditioned signal is then sent to processor 141 for processing and converting to a format compatible with the communication protocol / busAttorney Docket No. 3400-0365.02 (834PCT) running between the components. This protocol includes SPI, UART, I2C, CAN USB, IEEE1394 or the like. The signal conditioning unit 145 includes an amplifier 145a and signal filter-regulator 145b. The signal conditioning unit 145 conditions the sensed signal embedded with urine data captured from the sensing module 142, converts the signal to data to be processed in the processor 141 ready for transmitting to an external computing device 2. The data may also include identification information associated with the catheter 30 (denoted as CID) which is pre-programmed in the processor 141 during a specific configuration or calibration stage. Alternatively, CID may be stored in non-volatile memory within the MCU, such as EEPROM, flash memory, or the like. In another embodiment, the CID may further include embedded information, such as product details, manufacturing date and batch information etc. On the other hand, computing device 2 may be registered with the user identification information (UID) through a mobile APP, which may be mapped with the CID pre-programmed in processor 141 of smart catheter 30.

[0049] Optionally, the mobile APP may be programmed to retrieve the CID from the catheter 30 after pairing the computing device 2 with the catheter 30. The mobile APP may also include mapping the identification information associated with the catheter (CID) 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.

[0050] Now turning to the at least one output port, which includes wireless transceiver module 143, as illustrated in Fig. 5B. To transmit the urinary data and / or the identification data from the catheter 30 to the computing device 2, connection between the catheter 30 and the 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 catheter 30 and the computing device 2 with a physical cable. InAttorney Docket No. 3400-0365.02 (834PCT) various examples, transceiver / communication module 143 may include an antenna 143a, signal processing unit 143b and memory 143c. The transceiver / communication module 143 receives the urinary data and / or ID data processed from the processor 141 , recording it in memory 143c for further processing in the signal processing unit 143b. The signal processing unit 143b generates a transmission signal embedded with the data to be transmitted to the external computing device 2.

[0051] Optionally, the mobile app may include algorithm to transmit the mapped information and / or urine data to the healthcare network for verifying the user’s (patient’s) profile, processing and storing the information. The uniqueness of mapping of CID with UID inherent from the unique nature in both CID and UID ensure integrity and uniqueness of the catheter being used, and ultimately the uniqueness of mapping CID and UID, to avoid conflicting data or overwriting data unnecessarily. The CID mapped with the UID may be saved and logged in the healthcare system via the mobile app.

[0052] Optionally, data collected by the computing device 2 can be integrated with other systems, such as healthcare systems equipped with applications to perform data analysis, to provide real-time visibility for healthcare providers. This allows them 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.

[0053] The person having such an external 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 smart catheter 10, 30 and the system associated with the catheter 10, 30 may be used to generally track the bladder health based on the urinary data.

[0054] These are the exemplary input / output (I / O) communication ports employed in the smart catheter 10 of the present disclosure. Depending on the nature of the bladder health management designed for a subject, and the principles described herein, the catheter 10 and / or external powering device 27Attorney Docket No. 3400-0365.02 (834PCT) may be employed with other I / O communication ports without departing from the scope of the present disclosure.

[0055] Other Active Components

[0056] (A) Processor and its peripheral components

[0057] The processor 121 , 141 includes 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. The memory 1 16 may store the processed data until successful transmission of the data to the external computing device 2 is confirmed.

[0058] Other devices, systems, or means for connection / communication between smart catheter 10, 30 and other devices or computers are also possible. For example, smart catheter 10, 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 802.1 1 communication principles and / or similar communication principles may also be used. Smart catheter 10, 30 or the computing device 2 with which the smart catheter 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.

[0059] For example, the external computing device 2 is equipped with algorithm such as mobile app to convert the monitor data to meaningful information, for example, process the pressure sensor data to determine the volume and stress inside the subject’s bladder 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 anotherAttorney Docket No. 3400-0365.02 (834PCT) device. In another example, the transceiver module 123, 143 transmits filtered data to a server, or other device.

[0060] 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 smart catheter 10, 30 is primarily executing digitized 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 application 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.

[0061] (B) Sensors

[0062] The at least one sensing module 122, 142 are connected to the processor 121 , 141 . The sensing module(s) is optionally integrated into an in- stream sensor block which may include but is not limited to, a pressure sensor 22a, 42a a force sensor 22b, 42b, and optional motion sensors, such as a gyroscopic sensor 22c, 42c and accelerometer 22d, 42d, for example, as shown in Fig. 1 .

[0063] In one alternative, the pressure sensor 22a, 42a is of strain gauge type being placed in proximity to the eyelets 19 of the conduit 18. In measuring the pressure inside the bladder as it accumulates urine fluid, as the urinary fluid flows through the conduit 18, it produces a strain in the material of the sensor 22a, 42a resulting in a deformation of the sensor. The electrical resistance of the sensor thereby changes as it is deformed by the pressure, translating mechanical pressure into an electrical signal. This electrical signal is then processed and converted into a readable pressure data representing the pressure inside the bladder induced by the urine fluid. With the pressure being obtained, the healthcare clinicians may assess how pressure changes as the bladder fills to determine its capacity and whether it is functioning within normal limits. In regard to bladder compliance, pressure data may indicate how well the bladder can expand and hold urine without causing discomfort or damage.

[0064] In another embodiment, the strain gauge type of urine force senor 22b, 42b may be employed. Similar to the strain gauge type of urine pressure sensor,Attorney Docket No. 3400-0365.02 (834PCT) the force sensor 22b, 42b measures deformation or strain caused by force. The strain gauge changes the sensor electrical resistance as it deforms under the force exerted by the urine, converting this into an electrical signal. By measuring the force exerted as the bladder fills, healthcare clinicians can determine its functional capacity, which is the volume of urine the bladder can hold before the person feels the urge to urinate. Abnormally low or high capacities can indicate dysfunction. In regard to bladder compliance, the force data helps assess whether the bladder’s ability to store urine is compromised, which could lead to symptoms like urinary frequency or retention.

[0065] In yet another embodiment, motion sensors such as gyroscope sensor 22c, 42c may also, optionally, be employed. The gyroscope sensor detects the angular position and rotation in three-dimensional space, allowing it to detect tilt and orientational changes as the catheter is inserted into the urethra. By detecting the orientational changes, the gyroscopic sensor can monitor whether the catheter is aligned properly with the insertion pathway. If the catheter deviates from the recommended angle, the gyroscope detects this and can prompt the device to alert the user to adjust their angle.

[0066] In a still further embodiment, accelerometer 22d, 42d may also be included. The accelerometer 22d, 42d measures the linear acceleration, which in turns measures the speed of catheter insertion, and assists in monitoring the speed and directional displacement of the catheter. By detecting any sudden changes in insertion speed, the accelerometer can indicate whether the user is moving too quickly or too slowly. If the insertion speed exceeds the optimal range, the device can notify the user to slow down to prevent discomfort or potential injury.

[0067] In another exemplified catheter, the combination of gyroscopic sensor and accelerometer provides comprehensive detection on both angle and speed during inserting. The dual-sensor approach enhances the guidance system, providing users with a more intuitive and controlled insertion experience, reducing discomfort, and improving confidence and adherence to the correct technique.

[0068] Oftentimes, catheter users have limited dexterity and difficulty manipulating intermittent catheters during use. This can result in urineAttorney Docket No. 3400-0365.02 (834PCT) spillage / leakage during catheterization. The smart catheter system including catheters 10, 30 and the computing device 2 associated with the catheter 10, 30 disclosed herein reduces the risk of urine leakage / spillage given that the handheld, portable computing device 2 does not need to contact the urine or the catheter for analysis. Additionally, the portable device does not require cleaning after use, which is advantageous to users with limited dexterity.

[0069] Alert Triggering

[0070] Upon detecting abnormality of any one of the pressure, force, angular position, and / or speed of the catheter 10, 30, periodic (optionally multiple) alerts may be sent to the user, guiding them to follow the correct path of insertion. Based on the data provided from the gyroscope 22c, 42c and / or accelerometer 22d, 42d, the catheter 10, 30 can provide real-time feedback to the user about the catheter's force, angle, trajectory, and speed of insertion. If the catheter deviates from the optimal path, the device catheter 10, 30 alert the user indicating the need for adjustment. Typically, these alerts may be in the form of visual, audio or haptic / vibration or a combination thereof. In the exemplified catheter 10, 30, an alerting member may be incorporated into sensor assembly 20. The alerting member may produce haptic vibration feedback through a vibration actuator such as vibrating member or buzzer 127, 147. The choice of alert type or combination depends on various factors such as user preferences, the context of use, and accessibility consideration. For example, haptic vibration alert is used for users who may need to be discreet or when neither visual nor audible alert is suitable. In some variations, visual alert, such as LED (not shown), may be included to notify the user the operation status, and wireless communication status.

[0071] In this exemplification haptic vibration alert is triggered when the gyroscope 22c, 42c and / or accelerometer 22d, 42d detect catheter 10, 30 (i) optimal speed of insertion, (ii) deviation from the optimal path of insertion, (iii) optimal reach to the bladder and (iv) start of urination, e.g. from detecting sphincter muscle relaxation and contraction responses.

[0072] Optimal speed of insertionAttorney Docket No. 3400-0365.02 (834PCT)

[0073] The algorithm may include calculating the insertion rate based on the accelerometer’s linear acceleration data. It would compare this rate to preset optimal speed thresholds, triggering alerts if the speed is too high or too low.

[0074] Deviation from the optimal path of insertion

[0075] The algorithm may include defining ideal path thresholds such as angular parameter for an acceptable tilt or rotation, allowable speed range to ensure steady insertion, and resistance threshold that would be encountered along an ideal path. The system monitors changes in orientation from gyroscope data and changes in speed and direction from accelerometer data. Sudden changes in orientation, speed, and direction (such as spike or dips) indicating the catheter deviates from the expected insertion profile may trigger the corresponding haptic feedback to the user. The feedback may assist in prompting the user to adjust the catheter’s orientation or movement to re-align with the ideal insertion path.

[0076] Optimal reach to the bladder

[0077] The algorithm may include detecting the optimal reach to the bladder using a combination of gyroscope, accelerometer and pressure or force sensors which involves monitoring specific changes in position, movement patterns and pressure dynamics that indicate the catheter has reached the bladder. The algorithm may have a set of predefined thresholds in parameters such as pressure / force, angle of orientation and acceleration. These thresholds will be used, based on the measured parameters, to determine if there are any changes in the insertion profile. For example, in an unobstructed environment, when the catheter enters the bladder, resistance often decreases because the catheter is no longer encountering the restrictive forces of the urethra or sphincter. The bladder typically allows for more stable or unrestricted catheter orientation, with less forced bending. Once the bladder is reached, there is usually a stabilization in speed and movement since forward force decreases. Therefore, the exemplified algorithm is threshold-based which flags changes like pressure drop below the predefined threshold, indicating the open environment of the bladder, low rate of angular change indicating orientation stability, constant acceleration data identifying consistent linear movement of the catheter. These determinationsAttorney Docket No. 3400-0365.02 (834PCT) collectively confirm that the catheter is optimally positioned in the bladder and thereby another haptic (real-time) feedback corresponding to the optimal reach to the bladder may be triggered to inform the user that the catheter is in the optimal position.

[0078] Start of urination

[0079] The algorithm may include detecting the start of urination by identifying changes when encountering and passing through the sphincter. Under normal circumstances, urination does not start when the sphincter contracts. During the time the sphincter contracts, pressure / force sensor will detect increased resistance, gyroscope and accelerometer will detect sphincter engagement altering the catheter’s orientation or restricting forward movement. As soon as the sphincter relaxes causing a sudden release in resistance and a noticeable drop in resistance is detected by pressure sensor, another further haptic feedback is triggered to inform the user that urination starts.

[0080] The above said algorithm may be in modular base. In another exemplified algorithm in detecting the characteristics of urination, baseline sensor value may be measured by each sensor at the beginning of an operation, such as during the first stages of catheter insertion. The baseline reflects the typical or expected readings in a normal state (e.g., initial pressure, orientation, or speed) before specific events, like reaching the bladder, occur.

[0081] Communications interfacing within the system

[0082] In an exemplified arrangement, for purpose of establishing effective communication between the user (or environment) and the smart catheter 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 smart catheter 10, 30 and the external computing device 2 within the system 1 . The first interface includes the at least one sensingAttorney Docket No. 3400-0365.02 (834PCT) module 122, 142 and power unit 126, 146, whereas the second interface includes the transceiver / communication module 123, 143.

[0083] Referring to Figs. 5A and 5B, processor 121 , 141 is in communication with the pressure sensor 122a, 142a and the force sensor 122b, 142b to determine pressure and force exerted in the bladder filled with urinary fluid conveyed from the catheter 10, 30. As shown in the figures, processor 121 , 141 is also in communication with the gyroscopic sensor 122c, 142c and the accelerometer 122d, 142d to track the catheter’s angular position, rotation and linear acceleration during insertion. The memory 116 is used to save pressure and / or force data during use. It is an option that the memory internal to processor 121 , 141 can store data other than pressure and force depending on additional sensor necessary for additional parametric measurement, such as temperature of the urinary fluid.

[0084] The processor 121 , 141 is further configured to control the power unit 126, 146 powering up the catheter 10, 30 upon receiving RF signal from the external device 27 or urine flow. In this exemplary catheter, 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 catheter. The smart catheter 10, when it not in use, is configured in a low power mode or idle mode to conserve energy. Upon receiving the RF power signal from the external device 27, the processor 121 is configured to control the power unit 126 to power up the catheter 10. The processor 121 is further configured to receive the pressure signal and / or the force signal from the pressure sensor and the force sensor, 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 catheter 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, describedAttorney Docket No. 3400-0365.02 (834PCT) 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 catheter 10, the transmission between the catheter 10 and the computing device 2 is unidirectional from the catheter 10 to the 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 the computing device 2 is assumed opened) will be transmitted via the antenna 123a. The transmission signal is a short-range radiofrequency (RF) protocol as described in the above. In the exemplary, RF “Bluetooth” is used as communication protocol between the smart catheter 10 and the computing device 2.

[0085] The 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.

[0086] The smart catheter 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. The processor 121 may be configured to re-establish another connection to the 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.

[0087] Smart catheter 10 or the computing device 2 with which the smart catheter 10 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 which is accessible at the healthcare provider end.

[0088] Fig. 6 is a block diagram illustrating an exemplary external computing device 600 (2) according to the present disclosure. The computing device 600Attorney Docket No. 3400-0365.02 (834PCT) forms part of a catheter-associated urinary tract health monitoring system and can support the monitoring of the operating state of the catheter to be inserted into a user’s bladder. 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.

[0089] 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.

[0090] 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 catheter 10 and the computing device 2. The interface 603 is configured to receive monitor data MD from the smart catheter 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.

[0091] 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 catheter 10.

[0092] 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 archived in the computing devices or server 2 for a healthcare provider to review.

[0093] 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 theAttorney Docket No. 3400-0365.02 (834PCT) invention as set forth 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. 3400-0365.02 (834PCT)CLAIMS1 . A urinary catheter, comprising: a) a flexible catheter tube having a tube wall with an indentation therein, the flexible catheter tube having a distal end leading to an outlet and a proximal end with one or more openings in fluid communication an internal lumen extending within the catheter tube and allowing for urine to flow therethrough; b) a sensor assembly comprising a circuitry wiredly connected to at least one sensing module, wherein the sensor assembly further comprises a power unit for powering up the circuitry; and wherein the indentation is sized for accommodating at least the sensor assembly therein and wherein the at least one sensing module is associated with the tube wall and senses 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.

2. The urinary catheter according to claim 1 , wherein the circuitry connects to the at least one sensing module by a wiring connection.

3. The urinary catheter according to claim 2, wherein the wiring connection is ink printed wire.

4. The urinary catheter according to claim 2, wherein the sensor assembly and / or wiring connection is sealed, at least in part by a sealing element.

5. The urinary catheter according to claim 4, wherein the sealing element is UV curable resin.

6. The urinary catheter according to any one of claims 1 -5, wherein the sensor assembly is at or near the proximal end of the catheter.

7. The urinary catheter according to claim 6, wherein the power unit comprises a receiver coil and is activated by an external transmitter.

8. The urinary catheter according to any one of claims 1 -7, wherein the at least one sensing module is a pressure sensor.

9. The urinary catheter according to any one of claims 1 -8, wherein the at least one sensing module is a force sensor.

10. The urinary catheter according to claim 7, wherein the external transmitter comprises a transmitter coil, a transmitter power supply and an oscillator circuit;Attorney Docket No. 3400-0365.02 (834PCT) wherein the external transmitter transfers power from the transmitter coil to the receiver coil through induction coupling.1 1 . The urinary catheter according any one of claims 1 -10, 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.

12. The urinary catheter according to claim 11 , wherein the at least one input port interfacing 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 urinary catheter according to claim 12, wherein the at least one output port interfacing with the transceiver module for establishing wireless connection with a computing device.

14. A urinary catheter, comprising: a) a flexible catheter tube having a tube wall, a distal end leading to an outlet and a proximal end with one or more openings opposite to the distal end leading to an internal lumen that within the flexible catheter tube and allows for urine flowing therethrough; b) a sensor assembly comprising a circuitry wiredly connected to at least one sensing module and a power unit for powering up the circuitry and the at least one sensing module associated with the circuitry, wherein the at least one sensing module associated with the tube wall and sensing at least one characteristic of the urine and / or the urinary tract, the at least one sensing unit being configured to produce signal associated with the at least one characteristic; and wherein the sensor assembly, the at least one sensing module and the power unit are positioned inside of the tube wall, and wherein the power unit is exposed to the urine flowing through the internal lumen to generate power.

15. The urinary catheter according to claim 14, wherein the circuitry connects to the at least one sensing module and the power unit by a wiring connection.

16. The urinary catheter according to claim 15, wherein the wiring connection is ink printed wire.

17. The urinary catheter according to any one of claims 14-16, wherein the sensor assembly is a flexible substrate further comprising at least one input port,Attorney Docket No. 3400-0365.02 (834PCT) at least one output port, a processor and a transceiver module arranged on the circuitry.

18. The urinary catheter according to any one of claims 14-17, wherein the power unit is a microfluidic cell activated by the urine flow.

19. The urinary catheter according to claim 18, wherein the at least one input port interfacing 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 urine flow.

20. The urinary catheter according to claim 19, wherein the at least one output port interfacing with the transceiver module for establishing wireless connection with a computing device.21 . The urinary catheter according to claim 15, wherein the sensor assembly and wiring connection are sealed, at least in part by a sealing element.

22. The urinary catheter according to claim 21 , wherein the sealing element is UV curable resin.

23. The urinary catheter of according to any one of claims 14-22, wherein the at least one sensing module is a pressure sensor.

24. The urinary catheter according to any one of claims 14-23, wherein the at least one sensing module is a force sensor.

25. A system for analyzing urine flowing from a urinary catheter, comprising: the urinary catheter comprising: a) a flexible catheter tube having a tube wall with an indentation therein, the flexible catheter tube having a distal end leading to an outlet and a proximal end with one or more openings opposite to the distal end leading to an internal lumen that extends within the flexible catheter tube and allows for urine flowing therethrough; b) a sensor assembly comprising a circuitry wiredly connected to at least one sensing module wherein the sensor assembly further comprises a power unit for powering up the circuitry and the at least one sensing module associated with the circuitry; wherein the indentation is sized for accommodating at least the sensor assembly therein and wherein the at least one sensing module isAttorney Docket No. 3400-0365.02 (834PCT) located on the tube wall and sensing at least one characteristic of the urine and / or the urinary tract, the at least one sensing module being configured to produce signal associated with the at least one characteristic; and 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.

26. The system according to claim 25, wherein the sensor assembly further comprising a transceiver module to establish wireless connection with a computing device; wherein the computing device is configured to communicate with the sensor assembly in receiving the at least one characteristic of the urine for analysis.

27. A system for analyzing urine flowing from a urinary catheter, comprising: the urinary catheter comprising: a) a flexible catheter tube having a tube wall, a distal end leading to an outlet and a proximal end with one or more openings opposite to the distal end leading to an internal lumen that extends within the flexible catheter tube and allows for urine flowing therethrough; b) a sensor assembly comprising a circuitry wiredly connected to the at least one sensing module and a power unit for powering up the circuitry and the at least one sensing module associated with the circuitry; wherein the at least one sensing module is associated with the tube wall and sensing at least one characteristic to the urine and / or the urinary tract, the at least one sensing module is configured to produce signal associated with the at least one characteristic, wherein the sensor assembly further comprising a transceiver module for establishing wireless connection with a computing device; and wherein the sensor assembly, the at least one sensing module and the power unit are located on the inside of the tube wall;Attorney Docket No. 3400-0365.02 (834PCT) and wherein the power unit exposed to the urine to generate power; and the computing device is configured to wireless communicate with the urinary catheter in receiving the at least one characteristic of the urine for analysis.

28. The system according to claim 27, wherein the at least one sensing module comprising one or more of a pressure sensor, a force sensor, a gyroscope and accelerometer; and wherein the sensor assembly is configured to receive any one of a pressure signal, a force signal, an orientation signal and a speed of movement signal.

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