IL305008A

IL305008A - A diagnostic controllable catheter system

Info

Publication number: IL305008A
Application number: IL305008A
Authority: IL
Inventors: Avraham Segev
Original assignee: Avraham Segev
Priority date: 2023-08-07
Filing date: 2023-08-07
Publication date: 2024-08-01

Description

SEGEV-001 IL A DIAGNOSTIC CONTROLLABLE CATHETER SYSTEM Inventor: Avi Segev FIELD OF THE INVENTION [001] The present invention relates in general to apparatuses for bladder management, specifically to diagnostic controllable catheter systems for diagnosing various bladder and urine conditions and for controlling the emptying of the bladder.

BACKGROUND [002] A bladder walls consist of muscles that contract according to conscious commands received from the nervous system. The bladder is sealed by a sphincter muscle, which is a ring-like muscle that surrounds the urethral tube and can contract and close the urethral tube to thereby control the retention and release of urine from the bladder through the urethral tube thus preventing undesired leakage of urine. Under certain neurological/physical conditions, the function of the urethral sphincter muscle is impaired, thereby causing undesired and uncontrolled urinary leakage, i.e., urinary incontinence. [003] Urinary incontinence in women is a common phenomenon that many women over the age of forty suffer from due to various reasons. Urinary incontinence manifests in an involuntary leakage of urine that causes discomfort and embarrassment. [004] The most common and simple solution for urinary incontinence has been the use of a diaper or other absorbing pad. Such diapers or pads collect the leaked urine and prevent it from staining the pants. However, they are uncomfortable, cause intertrigo and are a source of embarrassment on their own. [005] Another solution is a urinary catheter connected to a collection bag. This solution was invented ages ago and is still in wide routine use. Notwithstanding its prolonged use, urinary catheters are prone to cause urinary infections. Furthermore, the connected carrying, and routine handling is cumbersome and may cause discomfort and embarrassment to the user. Moreover, this solution does not give the user any sense of control and merely provides external containment for the uncontrolled urine flow.

SEGEV-001 IL SUMMARY [006] In a first aspect, the present invention provides a diagnostic controllable catheter device (100) suitable for use within a user urethra and bladder, comprising: (a) a biocompatible tubular body that comprises: (i) a first end (110) intended to be positioned (iii) a tubular shaft (130) extending between said first and second ends; and (iv) an inlet aperture (111) and one or more outlet apertures (121) for enabling urine flow through said biocompatible tubular body; (b) one or more circumferential sealing arrangements (132) for sealing the surrounding between said tubular body and the urethra cavity, thereby preventing undesired urine flow around the inserted device (100); (c) one or more flow control valves (131) installed within said biocompatible tubular body for controlling the flow of urine therethrough; (d) a communication module that enables communicating with one or more remote control and computing devices; (e) a power supply module suitable for providing sufficient power to power consuming components of said diagnostic controllable catheter device (100); (f) one or more sensors (133, 134) suitable for collecting in vivo data, and transfer same to a control module; and (g) a control module (135) configured to receive and process in vivo data collected by said one or more sensors (133, 134) and to operate said one or more flow control valves (131), one or more sensors (133, 134), one or more circumferential sealing arrangements (132), and communication module, according to preconfigured modes of operation, while considering operational instructions received from predetermined one or more external computing devices and said in vivo data, wherein said device (100) is designed to enable the user to prevent urinary incontinence while providing diagnostic data of the bladder, urine and urethra. [007] In a second aspect, the present invention provides a bladder and urine diagnostic controllable catheter kit , comprising: (a) one or more diagnostic controllable catheter devices (100) of the invention; (b) an insertion device (200) for insertion of said diagnostic controllable catheter device (100) into a user urethra; and (c) a pamphlet containing operating instructions of said diagnostic controllable catheter device (100), and optionally with prognosis determination according to in vivo data collected by the one or more sensors of said device (100). [008] In a third aspect, the present invention provides a diagnostic controllable catheter system, comprising: (a) the diagnostic controllable catheter device (100) of the invention; (b) SEGEV-001 IL an insertion device (200) for insertion of said diagnostic controllable catheter device (100) into a user urethra; and (c) one or more computing devices configured to communicate with said diagnostic controllable catheter device (100). [009] In a fourth aspect, the present invention provides a bladder and urine diagnostic method, comprising the steps of: (a) installing a diagnostic controllable catheter device (100) of the invention (b) preventing encompassing flow through the urethra cavity surrounding the installed diagnostic controllable catheter device, by sealing the urethra cavity that surrounds the installed catheter device with circumferential sealing arrangements thereof; and (c) controlling the urine flow through the installed catheter device, according to preconfigured modes of operation, while considering operational instructions received from one or more predetermined external computing devices and in vivo data collected by the one or more sensors.

BRIEF DESCRIPTION OF THE DRAWINGS [010] For a better understanding of various embodiments of the invention and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which: [011] Figs. 1A-1D illustrate exemplary configurations of a diagnostic controllable catheter device according to an embodiment of the invention; [012] Fig. 1E is a photo of an exemplary configuration of the device of Fig. 1A , in which the external edge of the device that is designed to protrude from the urethra is obscured by a cover; [013] Fig. 1F illustrates the device of Fig. 1E within a urethra and bladder; [014] Fig. 2 illustrates an insertion device according to an embodiment of the invention; [015] Fig. 3is a system diagram that illustrates an exemplary configuration of a diagnostic controllable catheter system according to an embodiment of the invention; and [016] Fig. 4 illustrates an exemplary dashboard display of a designated mobile application running on one or more smartphones according to certain embodiments of the present invention. [017] Structural details of the invention are shown to provide a fundamental understanding of the invention. The description, taken with the drawings, making apparent to those skilled in the art how the several forms of the invention may be embodied in practice.

SEGEV-001 IL DETAILED DESCRIPTION [018] Urinary incontinence, also known as overactive bladder, means the loss of bladder control, and is a common and often embarrassing problem that causes people to avoid their normal activities. The severity ranges from occasionally leaking urine when you cough or sneeze to having an urge to urinate that s so sudden and strong you don t get to a toilet in time. While urinary incontinence can happen to anyone, it is more common in older people and women. [019] The present invention relates to a diagnostic controllable catheter device, which is designed to be inserted into a user urethra and bladder and provide the user with control over urine flow therethrough, thus, treating and preventing the symptoms of urinary incontinence. Furthermore, the diagnostic controllable catheter device disclosed herein leverages its post-insertion positioning for providing in vivo data related to the condition and contents of the user urethra and bladder, as well as various details of the urine itself. This in vivo data may be significant or even critical for diagnosing the present condition of the user using the device as will be explained in detail hereinafter. [020] Accordingly, in a first aspect, the present invention provides a diagnostic controllable comprising: (a) a biocompatible tubular body that comprises: (i) a first end (110) intended to be positioned (iii) a tubular shaft (130) extending between said first and second ends; and (iv) one or more inlet apertures (111) and an outlet aperture (121) for enabling urine flow through said biocompatible tubular body; (b) one or more circumferential sealing arrangements (132) for sealing the surrounding between said tubular body and the urethra cavity, thereby preventing undesired urine flow around the inserted device (100); (c) one or more flow control valves (131) installed within said biocompatible tubular body for controlling the flow of urine therethrough; (d) a communication module that enables communicating with one or more remote control and computing devices; (e) a power supply module suitable for providing sufficient power to power-consuming components of said diagnostic controllable catheter device (100); (f) one or more sensors (133, 134) suitable for collecting in vivo data, and transferring same to a control module; and (g) a control module (135) configured to receive and process in vivo data collected by said one or more sensors (133, 134) and to operate said one or more flow control valves (131), one or more sensors (133, 134), one or more SEGEV-001 IL circumferential sealing arrangements (132), and communication module, according to preconfigured modes of operation, while considering operational instructions received from predetermined one or more external computing devices and said in vivo data, wherein said device (100) is designed to enable the user to prevent urinary incontinence while providing diagnostic data of the bladder, urine, and urethra. [021] and as used herein throughout the application refer to various features in non-limiting embodiments of the present invention described herein for illustration purposes. Various combinations of the described embodiments and/or of specific features thereof are also possible. [022] The catheter device of the invention is designed with compact dimensions and low circumferential friction for enabling independent insertion thereof by any user- without the need for a professional, as well as a convenient and comfortable prolonged presence in the without the risk of contamination and irritation. [023] In certain embodiments of the device (100) of the invention, the tubular body further comprises any one of: (i) at its second end (120) one or more extraction anchors (122) for cover (123) mounted on the second end (120), such that when the device is placed inside the urethra, the second end (120) that protrudes outside the urethra is concealed by said cover, outlet area, and said cover is wider than the urethra outlet; (iii) a light-emitting module designed to emit pathogen-inactivating light (iv) an active agent designed to be released therefrom upon insertion into the urethra, said active agent may be an anti-bacterial, anti-fungal, and/or anti-viral agent, and may be designed for slow-release or immediate-release, for inhibiting or preventing biofilm or pathogens growth/formation thereon. [024] Different users have different physiology and different urethra lengths. Accordingly, the device (100) according to any of the embodiments above may be manufactured in different sizes and fixed lengths, or alternatively may be adjustable, in which case, the tubular body is extendable. In such cases, the device (100) may further include a locking mechanism designed to affix the length of the tubular body after its extension or shortening and prior to its insertion

[025] Notably, the length of the tubular shaft is predetermined (either during manufacture or by adjusting the tubular body so that the second end (120) of the diagnostic SEGEV-001 IL controllable catheter device (100) protrudes outside the urethra outlet, while the first end (110) resides within the bladder. [026] In certain embodiments of the device (100) according to any of the embodiments above, the control module is configured to submit operational and in vivo data collected by the one or more sensors to one or more remote computing devices through the communication module. [027] In certain embodiments of the device (100) according to any of the embodiments above, the one or more extraction anchors (122) are selected from: one or more pullout protrusions, one or more pullout wire connections, and any combination thereof. [028] In certain embodiments of the device (100) according to any of the embodiments above, the one or more circumferential sealing arrangements (132) are configured to be positioned at (i) , or (ii) the urethra, or both. Such circumferential sealing arrangements (132) may comprise a loaded spring sealing arrangement configured to exert a expanding it to seal its surrounding urethra cavity. Alternatively, such circumferential sealing arrangements (132) may comprise an inflatable annular bag, of which expansion seals its surrounding urethra cavity. [029] In certain embodiments of the device (100) according to any of the embodiments above, the one or more sensors are selected from the group consisting of: piezoelectric sensors, nanomaterial-based sensors, nano biosensors, image acquisition sensors (such as a camera that may allow diagnosis in identifying the spectrum of the urine, ultrasonic sensors, spectrally encoded endoscopes, and any combination thereof. [030] As explained above, the device (100) of the invention is designed, among others, to prevent unintentional release of urine by creating a physical blockage. However, failure to release accumulated urine in the bladder is dangerous. Accordingly, to prevent such urine accumulation in the bladder, the flow control valve(s) (131) of the device (100) according to any of the embodiments above, may be mechanically configured to be forced open (automatically) under a predefined load/pressure applied thereon when the bladder pressure reaches a predefined threshold, thereby preventing undesired urine accumulation. [031] In certain embodiments of the device (100) according to any of the embodiments above, the pathogen-inactivating light is of a wavelength of about 405 nm, and is: (i) emitted outwardly, i.e., towards a wall of the biocompatible tubular body facing the urethra cavity; (ii) SEGEV-001 IL emitted inwardly, i.e., into the tubular shaft (130); or (iii) emitted both inwardly and outwardly. [032] In specific embodiments, the present invention provides a diagnostic controllable biocompatible and optionally extendable, tubular body that comprises: (i) a first end (110) and having one or more extraction anchors (122) for retrieving said diagnostic controllable catheter device from the user ,; (iii) a tubular shaft (130) extending between said first and second ends; and (iv) one or more inlet apertures (111) and an outlet aperture (121) for enabling urine flow through said biocompatible tubular body; (b) one or more circumferential sealing arrangements (132) for sealing the surrounding between said tubular body and the urethra cavity, thereby preventing undesired urine flow around the inserted device (100); (c) one or more flow control valves (131) installed within said biocompatible tubular body for controlling the flow of urine therethrough; (d) a communication module that enables communicating with one or more remote control and computing devices; (e) a power supply module suitable for providing sufficient power to power-consuming components of said diagnostic controllable catheter device (100); (f) one or more sensors (133, 134) suitable for collecting in vivo data, and transferring same to a control module; (g) a control module (135) configured to receive and process in vivo data collected by said one or more sensors (133, 134) and to operate said one or more flow control valves (131), one or more sensors (133, 134), one or more circumferential sealing arrangements (132), and communication module, according to preconfigured modes of operation, while considering operational instructions received from predetermined one or more external computing devices (through said communication module) and said in vivo data; (h) optionally a concealing cover (123) mounted on the second end (120), such that when the device is placed inside the urethra, the second end (120) that protrudes outside the urethra is concealed by said cover, wherein said cover (123) has a texture similar to that of the skin surface at the urethra outlet area, and said cover is wider than the urethra outlet; and (i) optionally a light emitting module designed to emit pathogen-inactivating light (outwardly, inwardly, or both), wherein said device (100) is designed to enable the user to prevent urinary incontinence while providing diagnostic data of the bladder, urine, and urethra.

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[033] In specific embodiments, the above device (100) further comprises an active agent designed to be released therefrom upon insertion into the urethra.

[034] In certain embodiments of the device (100) according to any of the embodiments above is used for treating symptoms of urinary incontinence. [035] In certain embodiments, the present invention provides a method for treating symptoms of urinary incontinence, the method comprising the steps of providing the device (100) according to adder and urethra, thereby providing the user with control and obviating all urinary incontinence associated symptoms.

[036] In a second aspect, the present invention provides a diagnostic controllable catheter kit, comprising: (a) one or more diagnostic controllable catheter devices (100) according to any of the embodiments above; (b) one or more insertion devices (200) for (semi-automatic) (c) one or more pamphlets containing operating instructions of said one or more diagnostic controllable catheter device (100) and said one or more insertion devices (200), and optional prognosis determination instructions according to in vivo data collected by the one or more sensors (133,134) of said device (100). [037] In certain embodiments, the present invention provides a bladder, urethra, and urine diagnostic method, the method is based on using the device (100) according to any of the embodiments above, and receiving data obtained from its sensors, while preventing encompassing flow through the urethra cavity surrounding the installed diagnostic controllable catheter device (100) by sealing the urethra cavity that surrounds the installed catheter device with one or more circumferential sealing arrangements (132) thereof, and while controlling the urine flow through the installed catheter device, according to preconfigured modes of operation, while considering operational instructions received from one or more predetermined external computing devices (301, 302, 303) and in vivo data collected by the one or more sensors (133,134). [038] Accordingly, in a third aspect, the present invention provides a bladder, urethra, and urine diagnostic method, comprising the steps of (a) installing a diagnostic controllable catheter device (100) as hereinabove described (b) obtaining SEGEV-001 IL or collecting operational and in vivo data from the sensors (133, 134) and transmitting same to one or more external computing devices (301, 302, 303); (c) analyzing the transmitted results; and (d) providing analysis therefor, e.g., to the user or the medical caregiver, thereby providing diagnostics and optionally prognosis for each user based on the collected data. [039] In certain embodiments, the above method further comprises a step of collecting mass in vivo data submitted by multiple units of said diagnostic controllable catheter device (100) and producing a training dataset for an AI diagnostic tool(s). [040] In specific embodiments of any of the above-mentioned methods, the considered operational instructions received from one or more external computing devices (301, 302, 303) are provided by an AI diagnostic tool. [041] In certain embodiments of the method according to any of the embodiments above, outlet is carried out using an insertion device (200).

[042] In a fourth aspect, the present invention provides a diagnostic controllable catheter system , comprising (a) one or more diagnostic controllable catheter devices (100) according to any of the embodiments above; and (b) one or more computing devices (301, 302, 303) configured to communicate with said one or more diagnostic controllable catheter devices (100). [043] In certain embodiments of the above system, the computing devices (301, 302, 303) are configured to: (i) submit operational instructions to the diagnostic controllable catheter device (100); and/or (ii) receive and process in vivo data received from said diagnostic controllable catheter device (100), and to correspondingly execute one or more pre-configured actions. In specific embodiments thereof, the pre-configured actions are selected from the group consisting of: producing a user alert, producing a clinical alert, submitting operational commands to said diagnostic controllable catheter device (100), and storing and processing mass in vivo data collected by the one or more sensors for generating a training dataset of AI diagnostic tool(s).

[044] The invention will now be illustrated by reference to the accompanying drawings which are to be considered only as representative examples of possible embodiments of the devices, systems, and methods of the invention.

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[045] Fig. 1A illustrates an exemplary configuration of a diagnostic controllable catheter device (100) according to an embodiment of the present invention. The device (100) comprises a biocompatible tubular body (i.e., made-of or coated-with a biocompatible material) having a first end (110) intended to be positioned withend (120) to be positioned at the user urethra outlet, and a tubular shaft (130) extending therebetween. The first end (110) comprises one or more urine inlet apertures (111); the second end (120) comprises a urine outlet aperture (121); and the tubular shaft (130) comprises one or more flow control valves (131), such as a butterfly valve, or any other suitably sized flow valve, for controlling the urine flow therethrough. [046] The one or more flow control valve(s) (131) may be positioned at a predetermined position along the tubular shaft (130), such as shown in Figs. 1A-1E . The tubular shaft (130) further comprises one or more circumferential sealing arrangements, such as an inflatable annular bag (132) (a section view thereof is illustrated in Figs. 1A-1D ), for sealing the surrounding cavity between the tubular body and the encompassing urethra cavity, thereby preventing undesired urine flow around the catheter device (100). The position of such circumferential sealing arrangements may vary according to need, desire and personal physiology. Various filling substances (e.g., compressed gases, gels, liquids such as saline solution, compressed foamed agents) and filling methods may be used for inflating the inflatable annular bag (132) or any other inflatable sealing arrangement(s) used in different embodiments. [047] According to certain embodiments of the invention, the tubular shaft (130) comprises one or more transmission tubes in fluid communication with the inflatable annular bag (132) and with a corresponding filling inlet installed in the second end (120) through which filling substance is externally injected to fill, thus, to inflate the inflatable annular bag (132) following the insertion of catheter device (100) operation, the inlet is tightly closed by a suitable lid to retain the filling pressure, thus, maintaining the sealing provided by the inflated annular bag(s) (132). In an opposite manner, the inflatable annular bag (132) may be emptied/deflated prior to retrieving the catheter device (100) from the urethra. [048] In specific embodiments, biocompatible filling substances are used for avoiding discomfort or irritation even in unexpected breakage/leakage from the bag(s) (132). In certain embodiments, durable biocompatible materials (e.g., such as polyurethanes used in medical SEGEV-001 IL balloons) are used for manufacturing the inflatable annular bag (132), or any other inflatable sealing arrangement(s), to ensure its structural integrity. [049] Alternate locations of the circumferential sealing arrangement(s) (132) may be selected in accordance with alternate applications of the device (100) physiology. For instance, at the bladder outlet (see illustrated in Fig. 1A ), at the urethra (see illustrated in Fig. 1C ), anywhere along the device, or using two sealing arrangements at two locations (see illustrated in Fig. 1D ). [050] Furthermore, alternate types of sealing arrangement(s) (132) may be selected (i.e., alternative to inflatable bag (132)), a loaded spring arrangement installed within the wall of the shaft (130), or inner plungers configured to exert radial force on a predetermined portion thereof (i.e., when triggered or released), thus, to laterally expand that portion of the shaft (130) and seal its surrounding urethra cavity. [051] The device (100) according to any of the embodiments above may be made-of or coated-with a biocompatible material. A biocompatible coating may be applied on the external and/or internal surfaces of the device (100) in any suitable way during manufacturing. One non-limiting example of such a biocompatible coating material is Perylene C, which is known to be chemically resistant, a good electrical insulator, and stable for oxidation, as well as characterized with a low coefficient of friction, thus providing a smooth insertion of the device (100) through the urethra, and preventing bacterial adhesion and biofilm formation therein and thereon. The biocompatible coatings of the catheter device (100) may further comprise an active agent (e.g., anti-bacterial, anti-fungal, etc.), which is either a slow- or immediate-release medication(s) that suppresses and/or inhibit biofilm growth/formation while the catheter device (100) is in the urethra, thereby prolonging the activity/use span of the device (100) before replacing. [052] According to an embodiment of the present invention, light-emitting elements such as a blue light emitter (e.g., 405nm LED) are integrated within the catheter device (100) for irradiating its surrounding and/or its internal space and components with pathogen-inactivating light, thereby preventing biofilm formation/growth and enabling a prolonged presence of the device (100) . Plastic fibers/channels may be utilized for routing such inactivating light beam(s) to desired locations within and/or around the catheter device (100).

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[053] Further shown in Figs. 1A-1D are two extraction anchors (122) positioned, e.g., at the second end (120), which provide a grasping or connecting points for the retrieval of the device (100) its use or when needed to be replaced with another. Alternate shapes and dimensions of protruding or depressed extraction anchors (122) may be selected for providing a suitable grasp or anchorage corresponding to specifically desired applications of the device. [054] In certain embodiments, the tubular body of the device (100), according to any of the embodiments above, may be extended at least at a portion thereof to enable fitting thereof to different urethra lengths (i.e., where in its post-insertion position, the first end (110) is positioned within the and the second end (120) outlet as illustrated in Fig. 1F ). For example, the tubular shaft (130) may comprise an extension arrangement (e.g., telescopic arrangement). [055] To facilitate a real-time indication as to proper insertion and final positioning of a catheter device (100) of the invention, and as illustrated in Fig. 1F , an integrated sensor (133), such as a liquid-detection sensor, may be installed in a suitable location of the tubular shaft (130). In Fig. 1A , a sensor (133) is shown extending below the urine inlet apertures (111), so as to sense contact with urine therein, thereby providing an indication as to the extent to which the first end (110) is inserted, and particularly, to confirm that the first end (110) has reached the bladder, for instance by detecting a significant contact with urine, or to indicate its first contact with urine, thereby the user can infer that the catheter device is properly inserted, or that a further insertion (or extension) of the catheter device (100) is required. [056] In certain embodiments, the overall length of the catheter device (100) of the invention is predetermined, and a user selects a device with an appropriate length, determined, e.g., by preliminary evaluation, such as by ultrasound or other imaging scan, thereby enabling a custom-made device of appropriate length to individual users. In alternative embodiments, when the device is extendable, i.e., having at least a portion thereof that is extendable, the overall length of the catheter device (100) may be predetermined and fixed prior to the insertion thereof to the urethra, according to such preliminary evaluation. [057] Furthermore, the catheter device (100) may be selected or extended to a length so that a portion of or the entire second end (120) protrudes outside the urethra outlet, while the first end (110) resides within the bladder. Such configuration enables easier access to the second end (120), such as for grasping the extraction anchors (122) and retrieving the device (100).

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[058] Fig. 1E is a photo of an exemplary configuration of a device (100) according to certain embodiments, in which the external protrusion of the second end (120) is obscured by a cover (123) that may be designed with a texture that resembles outlet area, to thereby conceal the presence of the protruding second end (120). In certain embodiments, the cover (123) is wider than the urethra outlet and is firmly secured to the second end (120), e.g., by threading, bayonet arrangement, or any other connection with the second end (120) such as to the extraction anchors (122), thereby preventing unintentional sliding of the device (100) further dipper into the user urethra and bladder. [059] Some of the components of the device (100), such as the communication and power supply modules, may require periodical wired connectivity with external devices, e.g., for firmware updates, battery recharge, and the like. In corresponding embodiments, those components are installed at/near the second end (120) of the device (100), while the cover (123) also provides a liquid-tight and thermally/electrically isolated concealment for such wire connection ports. [060] Sensors (133, 134), shown e.g., in Figs. 1Aand 1E , may also be utilized to collect, in vivo, data such as data urine, urethra, and bladder. The collected data is then transmitted to, and processed by an integrated control module (135), e.g., integrated within a double partitioned wall of the device (100). [061] The collected in vivo data may either be locally processed by the integrated control module (135) and directly affect the operation of the catheter device (100), e.g., according to preconfigured modes of operation associated with the received in vivo data, preconfigured in a memory device of the control module (135), and/or be transmitted to a predetermined external computing device(s), optionally along with operational information (e.g., the state of the valve(s) (131)) such as for storage and/or further processing. Such external computing device(s) (e.g., computers 302 and smartphone 303 illustrated in Fig. 3 ) may be used by medical personnel for monitoring users of the catheter device (100) and receiving clinical alerts in predefined abnormal conditions. In such conditions, the medical personnel may contact the user following an alert from the catheter device (100) and/or submit an operational command to the catheter device (100), such as to trigger the integrated control module (135) to immediately open the valve(s) (131). Additionally, external computing device(s) may collect in vivo data submitted by multiple units of the catheter device (100), for research and/or for generating and improving training datasets for Artificial Intelligence (AI) diagnostic tools.

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[062] The abovementioned AI diagnostic tools may be subsequently utilized for real-time diagnosis of clinical conditions, based on newly received in vivo data of users of the catheter device (100). Accordingly, the AI diagnostic tools may submit operational instructions to the relevant catheter device(s) (100). [063] In certain embodiments, the control module (135) is configured to receive and process in vivo data collected by said one or more sensors (133, 134), and to operate at least one, some, or all of said: one or more flow control valves (131), sensors (133, 134), circumferential sealing arrangement (132) (e.g., expansion thereof upon insertion of the device (100) into the bladder), and a communication module (e.g., a Wi-Fi module, Bluetooth module, Near Field Communications (NFC), or any other (individual or a combination of) communication modules suitable for integration in the catheter device (100)), according to preconfigured modes of operation, while considering both (i) operational instructions received from a predefined remote computing device (e.g., an AI diagnostic system), an associated in-charge physician, etc.), and (ii) said in vivodata detected by the sensors (133, 134). For instance, an arbitrary opening of the valve(s) (131) can be scheduled upon detection of overpressure in the bladder accompanied by an alert to the user to enable sufficient time to reach the toilet. [064] The sensors (133, 134) used in the device (100) can vary according to need and desire and are intended to cover a wide range of tasks. For instance, they may comprise sensors suitable for detecting and/or measuring physiological, chemical, and biological parameters, such as any one or more of: various parameters of the bladder such as pressure, size, and temperature; various parameters of the urine such as pH, salts, and contaminants; and parameters related to the overall urinary tract functioning, such as flow capacity. Such parameters may be detected and measured by commonly known sensors (e.g., piezoelectric sensors) that are available in small dimensions for suitable integration within the catheter device (100). [065] According to certain embodiments of the device (100) according to any of the embodiment above, the sensors (133, 134) (or additional sensors that are integrated with the device (100)) comprise nanomaterial-based sensors such as electrochemical and optical biosensors suitable for detecting and measuring various such as urine acidity (pH) and opacity, and to detect the presence and/or concentration of various chemical and biological substances, such as glucose, ketones (e.g., acetone), proteins, SEGEV-001 IL red blood cells, white blood cells, specific gravity of urine, nitrites, bilirubin, urobilinogen, aptamer-based sensors, biological enzymes, LH hormone, microalbumin, nitride, beta-human chorionic gonadotropin, casts pathogens, tumor markers, and other chemical/biological related to various medical conditions. Other sensors may also measure Beta human chorionic gonadotropin, Casts, and Pulse in the bladder. [066] The sensors (133, 134) may also comprise ultrasonic and/or image acquisition sensors (e.g., Spectrally Encoded endoscope) for providing visual data related to the physical state of the bladder tissue and/or urethra tissue, or to unexpected changes thereof or foreign objects therein, thereby providing, for instance, an early detection of bladder infections, crystals, or tumors. Such visual data may also provide important clinical information such as that related to insufficient urine discharge capacity, or incomplete bladder void conditions. For example, the collected in vivo data may include pressure levels within the bladder detected by a pressure sensor (e.g., installed, at the first end (110) of the catheter device (100), which is positioned within the bladder). In certain embodiments, the detected pressure levels are monitored continuously and processed by the abovementioned integrated control module (135) with respect to a predefined pressure level that is indicative of a full bladder, and thereby the bladder fullness state and filling pace can be inferred. The integrated control module (135)may submit (i.e., through the abovementioned communication module) the inferred information to, e.g., a smartphone (e.g., carried by the user of the device (100)), or to any other computing device paired with the catheter device (100), as further explained hereinafter. Thereby, users of the catheter device (100) according to any of the embodiments above can be constantly updated by their smartphone as to their bladder fullness state and when it should be emptied. [067] Furthermore, even those users with a totally impaired sense of bladder, e.g., due to neurological and other physiological conditions, can regain control over their evacuation timing and their daily routine by using the device (100) of the invention. Moreover, users with weak pelvic muscles (i.e., who may not be able to hold any quantity of urine in their bladder)can avoid undesired urine leaks as well as being capable to empty their bladder in the toilet rather than using an externally carried collection bag. [068] Another example is an integration of in vivo data collected by two different types of sensors, for instance, visual detection of a foreign or suspicious object within the bladder, by an ultrasound sensor and chemical detection of a predefined tumor marker by a biosensor, by SEGEV-001 IL which the control module (135) is configured to infer and submit the detected in vivo data within an immediate-attention-required alert to a predefined remote computing device being monitored by medical personnel, such as a computer or smartphone. [069] While a valve (131) of the catheter device (100) according to any of the embodiments above may be controlled by a user who receives a bladder full alert, reaches a toilet, and a smartphone application (i.e., followed by which the control module (135) triggers the valve (131) to open), the control module (135) may also be configured to open the valve (131) upon detecting a bladder pressure rise above a predefined threshold, for preventing dangerous overpressure within the bladder. [070] According to certain embodiments, the valve (131) is mechanically configured to be forced open (optionally automatically) under a predefined load applied thereon when the bladder pressure reaches a predefined threshold, thereby preventing dangerous pressure levels within the bladder. For example, the valve(s) (131) may comprise a spring-loaded hinged membrane (not shown), where the spring, that resists rotation of the membrane hinge, is preselected with a desired spring factor that corresponds to the predefined threshold bladder pressure, that shall arbitrarily open the valve(s) (131). [071] The aforesaid overpressure controlled/mechanically forced protection enables the users of the device (100) according to any of the embodiment above, to voluntarily reach a toilet, retract (put pressure on) their bladder, thus increasing the bladder pressure and trigger the control module (135) to open the valve(s) (131), or if the latter fails, to force the aforesaid hinged membrane to open. [072] In some cases, the user(s) of the catheter device (100) may not be able to retract their bladder, thus, to completely empty their bladder. Such a condition may be uncomfortable since it may require more frequent visits to the toilet. Accordingly, in certain embodiments, the catheter device (100) according to any of the embodiment above further comprises an internal auxiliary pump (not shown), which may be operated by the control module (135), in considering pressure, visual, or liquid-contact input received from the sensor(s) (133,134)). [073] The sensors (133,134) provide continuous or periodic monitoring of a urine, urethra, and bladder, by the abovementioned and by any other commercially available sensors that are used for diagnostic purposes.

SEGEV-001 IL

[074] One skilled in the art will readily realize various communication modules and power supply modules that are suitable for integration within the catheter device (100) of the invention. Such modules are not shown in the figures for the sake of illustration simplicity and are understood to be sized and shaped to be suitably integrated within the device (100). The power supply module is designed to supply power to the different sensors (133, 134) in the device, to the communication module, and to any other power-consuming component within the device (100). [075] Fig. 1F illustrates an embodiment of a catheter device (100) of the invention installed within a user urethra (140) and bladder (150), where the catheter is positioned within the (150), the second end (120) extends outside the urethraoutlet, with the protruding portion thereof concealed by a cover (123).

[076] Fig. 2illustrates a semi-automatic insertion device (200) for a device (100) according to any of the embodiments above. As illustrated, the insertion device (200) comprises a main body (210) and a spring-loaded arrangement comprising a slidable base (221) supported by one or more springs (222). For example, the spring(s) (222) may be enclosed in one or more cavities (211) defined by one or more partitions (212) at the periphery of the main body (210), and the slidable base (221) may comprise lateral extension(s) (221a) being in closed relationship with springs (222) (e.g., lateral extension(s) (221a) may extend through corresponding groove(s) in the partition(s) (212) and above the spring(s) (222)), thereby the catheter device (100) may be stored in the insertion device (200) supported on top the slidable base (221) while the lateral extension(s) (221a) compresses the spring(s) (222) downwardly. [077] Optionally, a latching mechanism (not shown) having, e.g., an internal protrusion above the lateral extension(s) (221a) and an external protrusion (e.g., on the external wall of the insertion device (200)), is used as a trigger that restricts and holds the slidable base (221) at its lowest position, while the spring(s) (222) are compressed there under, whereas when the latching mechanism is shifted by the user, its protrusion above the lateral extension(s) (221a) is shifted aside, thus releasing the slidable base (221) and the spring(s) (222). [078] Upon release of the spring(s) (222), the slidable base (221) is pushed upwardly (in the illustrated orientation of Fig. 2 ), forcing the catheter device (100) to exit the main body (210). A user may hold the insertion device (200) with the first end (110) at the urethra outlet and then release the springs (222), e.g., by pressing a corresponding knob, thereby forcing the SEGEV-001 IL device (100) into the urethra. Notably, the springs (222) are selected with a spring factor that derives an insertion load of the device (100) which is convenient to the user thereof. [079] Alternatively, the insertion device (200) may comprise a pneumatic or an electric plunger to drive the device (100) according to any one of the embodiments above into the urethra. This may provide a more controllable and slow insertion of the device (100) into the urethra. [080] Many alterations and modifications may be made by those having ordinary skill in the art without departing from the spirit and scope of the invention. Therefore, it must be understood that the illustrated embodiment has been set forth only for the purposes of example and that it should not be taken as limiting the invention as defined by the following invention and its various embodiments and/or by the following claims. [081] Fig. 3 is a system diagram that illustrates an exemplary configuration of a diagnostic controllable catheter system (300), according to an embodiment of the present invention. In Fig. 3 , the system (300) comprises a catheter device (100) installed athat is running a designated mobile application, and therethrough, with remote computers (302), to which in vivo data collected by the sensors (133,134) may be submitted for storage and further analysis. Further shown in Fig. 3 is a smartphone (303)caregiver, physician, or other predefined contact person. [082] For example, when the sensors (133, 134) detect a high urine concentration (i.e., over a preconfigured threshold), the control module smartphone (301), urging the user to drink water. In another example, when the sensors (133, 134) detect a very high urine concentration combined with a high body temperature (e.g., of over 40ºand according to specific embodiments, to a preconfigured contact phones associated to emergency medical assistance services. The remote computers (302) may also be used by a diagnostic system that may analyze further parameters detected and/or measured by the sensors (133, 134), and thereby may diagnose a more complex condition associated with the , for instance, high bilirubin concentration that may imply on jaundice disease. [083] Fig. 4 illustrates an exemplary dashboard (400) display of a designated mobile application running on a smartphone (301, 303), according to certain embodiments. The SEGEV-001 IL dashboard (400) may include indications as to the: (i) by a thermal sensor) showing two exemplary temperature indicators (401), urine acidity (402) (i.e., measured by a pH sensor), and urine color index (403) (e.g., detected by a Spectrally Encoded endoscope). As illustrated in Fig. 4 , the pointer (arrow 403a) of the urine color index (403) indicates red urine is detected. In such a case, the designated mobile application may further initiate an the smartphones (301,303) (e.g., audial/visual alert, urgent SMS message). [084] The designated mobile application running on smartphones (301,303) may differ by presenting different dashboards (400) for users/medical personnel. For example, the may be configured to include further indicators corresponding to specific medical conditions experienced by specific users. Furthermore, in the specific case of red urine, as indicated by the indicator (403) in Fig. 4 , the instance, to enable the physician to submit operational commands to the catheter device (100) such as to operate further sensors (133,134) thereby to enable broader diagnosis. [085] According to an embodiment of the present invention, a diagnostic controllable catheter kit is provided, comprising: (i) one or more units of the catheter device (100) according to any of the embodiments above, (ii) one or more insertion devices (200) for semi- as described hereinabove; and (iii) one or more pamphlets containing operating instructions for the catheter devices (100) and the insertion devices (200), and optional prognosis determination according to in vivo data collected by the sensors (133, 134) of the catheter device (100).

Claims

SEGEV-001 IL 305008 / CLAIMS

1. A diagnostic controllable catheter device (100) suitable for use within a user’s urethra and bladder, comprising: a) a biocompatible tubular body that comprises: i) a first end (110) intended to be positioned within a user’s bladder; ii) a second end (120) to be positioned at the user’s urethra outlet; iii) a tubular shaft (130) extending between said first and second ends; and iv) one or more inlet apertures (111) and an outlet aperture (121) for enabling urine flow through said biocompatible tubular body; b) one or more circumferential sealing arrangements (132) for sealing the surrounding between said tubular body and the urethra cavity, thereby preventing undesired urine flow around the inserted device (100); c) one or more flow control valves (131) installed within said biocompatible tubular body for controlling the flow of urine therethrough; d) a communication module that enables communicating with one or more remote computing devices; e) a power supply module suitable for providing sufficient power to power-consuming components of said diagnostic controllable catheter device (100); f) one or more sensors (133, 134) suitable for collecting in vivo data, and transferring same to a control module; and g) an integrated control module (135) configured to receive and process in vivo data collected by said one or more sensors (133, 134) and to operate said one or more flow control valves (131), one or more sensors (133, 134), one or more circumferential sealing arrangements (132), and communication module, according to preconfigured modes of operation, and said in vivo data, wherein said device (100) is designed to enable the user to prevent urinary incontinence.

2. The device (100) according to claim 1, wherein the control module (135) is further configured to receive operational instructions from predetermined one or more external computing devices, and accordingly, to operate one or more of said one or more flow control SEGEV-001 IL 305008 / valves (131), one or more sensors (133, 134), one or more circumferential sealing arrangements (132), and communication module.

3. The device (100) according to claim 1, wherein said tubular body further comprises at its second end (120) one or more extraction anchors (122) for retrieving said diagnostic controllable catheter device from the user’s urethra.

4. The device (100) according to claim 1-3, wherein said tubular body is extendable.

5. The device (100) according to any one of claims 1-4, wherein said control module is configured to submit operational and in vivo data collected by the one or more sensors to one or more remote computing devices through said communication module.

6. The device (100) according to claim 3, wherein said one or more extraction anchors (122) are selected from: one or more pullout protrusions, one or more pullout wire connections, and any combination thereof.

7. The device (100) according to any one of claims 1-6, wherein the length of the tubular shaft is predetermined so that the second end (120) of the diagnostic controllable catheter device (100) protrudes outside the urethra outlet, while the first end (110) resides within the bladder.

8. The device (100) according to any one of claims 1-7, further comprising a concealing cover (123) mounted on the second end (120), such that when the device is placed inside the urethra, the second end (120) that protrudes outside the urethra is concealed by said cover, wherein said cover (123) has a texture similar to that of the user’s skin surface at the urethra outlet area, and said cover is wider than the urethra outlet.

9. The device (100) according to any one of claims 1-8, wherein the one or more circumferential sealing arrangements (132) are configured to be positioned at the bladder’s outlet.

10. The device (100) according to any one of claims 1-9, wherein the one or more circumferential sealing arrangements (132) are configured to be positioned at the urethra. SEGEV-001 IL 305008 /

11. The device (100) according to any one of claims 1-10, wherein said one or more circumferential sealing arrangements (132) are configured to be positioned at both the bladder’s outlet and the urethra.

12. The device (100) according to any one of claims 1-11, wherein said one or more circumferential sealing arrangements (132) comprise a loaded spring sealing arrangement configured to exert a radial force on a portion of the tubular body’s wall, thus, to laterally expand it to seal its surrounding urethra cavity.

13. The device (100) according to any one of claims 1-12, wherein said one or more circumferential sealing arrangements (132) comprise an inflatable annular bag, of which expansion seals its surrounding urethra cavity.

14. The device (100) according to any one of claims 1-13, wherein said one or more sensors are selected from the group consisting of: piezoelectric sensors, nanomaterial-based sensors, image acquisition sensors, ultrasonic sensors, spectrally encoded endoscopes, and any combination thereof.

15. The device (100) according to any one of claims 1-14, wherein at least one of the one or more flow control valves (131) is mechanically configured to be forced open under a predefined load applied thereon when the bladder pressure reaches a predefined threshold.

16. The device (100) according to any one of claims 1-15, wherein said device (100) further comprises a light emitting module designed to emit pathogen-inactivating light.

17. The device (100) according to claim 16, wherein said pathogen-inactivating light is of a wavelength of about 405nm.

18. The device (100) according to claim 16 or 17, wherein said pathogen-inactivating light is emitted outwardly, i.e., towards a wall of the biocompatible tubular body facing the urethra cavity.

19. The device (100) according to claim 16 or 17, wherein said pathogen-inactivating light is emitted inwardly, i.e., into the tubular shaft (130).

20. The device (100) according to claim 16 or 17, wherein said pathogen-inactivating light is emitted both inwardly and outwardly. SEGEV-001 IL 305008 /

21. The device (100) according to any one of claims 1-20, wherein said device (100) further comprises an active agent designed to be released therefrom upon insertion into the urethra.

22. The device (100) according to claim 21, wherein said active agent is an anti-bacterial, anti-fungal, and/or anti-viral agent.

23. The device (100) according to claim 21 or 22, wherein said active agent is designed for slow-release or immediate-release, for inhibiting or preventing biofilm or pathogens growth/formation thereon.

24. The device (100) according to any one of claims 1-23, for treating symptoms of urinary incontinence.

25. A diagnostic controllable catheter kit, comprising: a) one or more diagnostic controllable catheter devices (100) of any one of claims 1-22; b) one or more insertion devices (200) for (semi-automatic) insertion of said diagnostic controllable catheter device (100) into a user’s urethra; and c) one or more pamphlets containing operating instructions of said one or more diagnostic controllable catheter device (100) and said one or more insertion devices (200), and optional prognosis determination instructions according to in vivo data collected by the one or more sensors (133,134) of said device (100).

26. A diagnostic controllable catheter system, comprising: a) one or more diagnostic controllable catheter devices (100) of any one of claims 1-22; and b) one or more computing devices (301, 302, 303) configured to communicate with said one or more diagnostic controllable catheter devices (100).

27. The system according to claim 26, wherein said one or more computing devices (301, 302, 303) are configured to submit operational instructions to said diagnostic controllable catheter device (100).

28. The system according to claim 26 or 27, wherein said one or more computing devices (301, 302, 303) are configured to receive and process in vivo data received from said diagnostic controllable catheter device (100), and to correspondingly execute one or more preconfigured actions. SEGEV-001 IL 305008 /

29. The system according to claim 28, wherein said preconfigured actions are selected from the group consisting of: producing a user alert, producing a clinical alert, submitting operational commands to said diagnostic controllable catheter device (100), and storing and processing mass in vivo data collected by the one or more sensors for generating a training dataset of AI diagnostic tool(s).

30. A bladder, urethra, and urine diagnostic method, comprising the steps of: a) installing a diagnostic controllable catheter device (100) of any one of claims 1-through a user’s urethra outlet; b) collecting operational and in vivo data from the sensors (133, 134) and transmitting same to one or more external computing devices (301, 302, 303) for analysis; and c) providing analysis results.

31. The diagnostic method of claim 30, further comprising a step of collecting mass in vivo data submitted by multiple units of said diagnostic controllable catheter device (100) and producing a training dataset for an AI diagnostic tool(s).

32. The diagnostic method of claim 30 or 31, wherein said considered operational instructions received from one or more external computing devices (301, 302, 303) are provided by an AI diagnostic tool.

33. The diagnostic method of any one of claims 30-32, wherein step (a) of installing a diagnostic controllable catheter device (100) through a user’s urethra outlet is carried out using an insertion device (200).