Portable catheterization monitoring system

Abstract

A portable urinary catheter monitoring device. More particularly, a portable urinary catheter monitoring device associated with a computing device. Even more particularly, a portable urinary catheter monitoring device configured to detect flow characteristics of urine.

Description

Attorney Docket No. 3400-0338.01 (816PCT)PORTABLE CATHETERIZATION MONITORING SYSTEMThe present application claims the benefit of and priority to U.S. Provisional Application 63 / 691 ,443, filed September 6, 2024, which is hereby incorporated herein by reference.FIELD OF THE INVENTION

[0001] This disclosure generally relates to devices, systems, and methods for monitoring urinary catheterization. In particular, the disclosure relates to a portable urinary catheter monitoring device, system, and method of using the same.BACKGROUND

[0002] Patients with spinal cord injuries (SCI) or other neurogenic bladder conditions typically need to empty their bladders by intermittent urinary catheterization. In some instances, intermittent catheterization is a good option for many users who suffer from various abnormalities of the urinary system. With the advent of intermittent urinary catheters, individuals with problems associated with the urinary system can conveniently self-catheterize to drain the individual’s bladder.

[0003] It is particularly important during the initial weeks of catheterization or a change of catheter usage regime that fluid volume data is collected to assist the user in managing their catheterization properly. Additionally, there is often a disconnect between a clinician (such as a urologist), catheter manufacturers, catheter distributors, and the catheter user (patient) in any catheter usage regime. The need to manage self-catheterization and such a disconnect can overwhelm the catheter user.

[0004] Proper catheterization can minimize the risk for developing infection and other complications. Certain products exist to keep track of a user’s catheterization. A user may share this information with a clinician to monitor or adjust a user’s regime or diagnose a condition. Yet, users may forget to input data regarding catheterizations, forget to share information with the clinician, and / or not see / speak to their clinician for a period of time. This may leave gaps in catheterization data.

[0005] Therefore, there is a need for improved catheterization monitoring products and systems.Attorney Docket No. 3400-0338.01 (816PCT)SUMMARY OF INVENTION

[0006] There are several aspects of the present subject matter which may be embodied separately or together in the subject matter 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 combination as set forth in the claims appended hereto.

[0007] In one aspect, a portable urinary catheter monitoring device is provided. The portable urinary catheter monitoring device includes a base and a barrel connected to the base. The barrel is at least partially circumferentially enclosed and includes a first end and a second end. A channel is defined by the at least partially circumferentially enclosed barrel. The channel extends between the first end and the second end and is configured to receive a portion of an intermittent urinary catheter. The portable urinary catheter monitoring device includes a flow meter assembly located in the channel and a controller associated with the flow meter assembly. The controller is configured to receive data from the flow meter assembly and to transmit the data to a computing device.

[0008] In another aspect, a method of monitoring catheterization is provided. The method includes attaching an intermittent urinary catheter to a portable urinary catheter monitoring device. The intermittent urinary catheter includes a proximal insertion end, a distal drainage end, and a catheter tube extending between the proximal insertion end and the distal drainage end. The portable urinary catheter monitoring device includes a base and a barrel connected to the base. The barrel is at least partially circumferentially enclosed and includes a first end and a second end. A channel is defined by the at least partially circumferentially enclosed barrel. The channel extends between the first end and the second end and is configured to receive a portion of an intermittent urinary catheter. The portable urinary catheter monitoring device includes a flow meter assembly located in the channel and a controller associated with the flow meter assembly. The controller is configured to receive data from the flow meter assembly and to transmit the data to a computing device. The method further includes transmitting the data to a computing device.Attorney Docket No. 3400-0338.01 (816PCT)

[0009] In another aspect, a system for monitoring intermittent urinary catheterization is provided. The system includes an intermittent urinary catheter including a proximal insertion end, a distal drainage end, and a catheter tube extending between the proximal insertion end and the distal drainage end. The system further includes a portable urinary catheter monitoring device. The device includes a base and a barrel connected to the base. The barrel is at least partially circumferentially enclosed and includes a first end and a second end. A channel is defined by the at least partially circumferentially enclosed barrel. The channel extends between the first end and the second end and is configured to receive a portion of an intermittent urinary catheter. The portable urinary catheter monitoring device includes a flow meter assembly located in the channel and a controller associated with the flow meter assembly. The controller is configured to receive data from the flow meter assembly and to transmit the data to a computing device. The system also includes the computing device.

[0010] In another aspect, a portable urinary monitoring device is provided. The device includes a primary path adapted to receive a fluid and extending from a first end to a second end, a shunt path extending from a first opening in the primary path and allowing fluid to flow to a second opening in the primary path, and a fluid monitoring circuit associated with the shunt path. The fluid monitoring circuit monitors the fluid to determine a characteristic of the fluid.

[0011] In another aspect, a portable urinary monitoring device is provided. The device includes a primary path adapted to receive a fluid and extending from a first end to a second end, a shunt path extending from a first opening in the primary path and allowing fluid to a second opening in the primary path, and a capacitor associated with the shunt path. The capacitor monitors the fluid to determine a characteristic of the fluid.

[0012] In another aspect, a method of implementing a portable urinary monitoring device is provided. The method includes providing a primary path adapted to receive a fluid and extending from a first end to a second end, providing a shunt path extending from a first opening in the primary path and allowing fluid to flow to a second opening in the primary path, and coupling a fluid monitoring circuit to the shunt path. The method further includes monitoring, using the fluid monitoring circuit, the fluid to determine a characteristic of the fluid.Attorney Docket No. 3400-0338.01 (816PCT)BRIEF DESCRIPTION OF DRAWINGS

[0013] FIG. 1 is a front perspective view of an example of a portable urinary catheter monitoring device.

[0014] FIG. 2 is a rear view of the portable urinary catheter monitoring device of FIG. 1.

[0015] FIG. 3 is a front perspective view of another example of a portable urinary catheter monitoring device.

[0016] FIG. 4 is a rear view of the portable urinary catheter monitoring device of FIG. 3.

[0017] FIG. 5 is a perspective view of an example of the urinary catheter monitoring device of FIG. 1 including a urinary catheter attached thereto.

[0018] FIG. 6 is a perspective view of an example of the urinary catheter monitoring device of FIG. 3 including a urinary catheter attached thereto.

[0019] FIG. 7 is a perspective view of an example of the urinary catheter monitoring device of FIG. 3 including a urinary catheter attached thereto.

[0020] FIG. 8A is a perspective view of an example of an electromagnetic sensor.

[0021] FIG. 8B is a front perspective view of an example of a core of the electromagnetic sensor of FIG. 8A.

[0022] FIG. 9 is a perspective view of an example of a urinary catheter monitoring device including an electromagnetic sensor.

[0023] FIG. 10A is a cross-sectional plan view of an example of a Hall-effect sensor in the channel of a portable urinary catheter monitoring device of the present disclosure.

[0024] FIG. 10B is a cross-sectional plan view of another example of a Halleffect sensor in the channel of a portable urinary catheter monitoring device of the present disclosure.

[0025] FIG. 1 1 is a cross-sectional plan view of an example of a thermal sensor in the channel of a portable urinary catheter monitoring device of the present disclosure.

[0026] FIG. 12 is a bottom view of an example of a portable urinary catheter monitoring device including a thermal sensor.

[0027] FIG. 13 is a perspective view of an example of an intermittent urinaryAttorney Docket No. 3400-0338.01 (816PCT) catheter.

[0028] FIG. 14 is a perspective view of another example of an intermittent urinary catheter.

[0029] FIG. 15 is a plan view of a catheterization monitoring system including a portable urinary catheter monitoring device of the present disclosure.

[0030] FIG. 16 is a cross-sectional view of a device monitoring urine flow in a catheter.

[0031] FIG. 17 is a perspective view of a portable fluid monitoring device adapted to contain the elements of the device of Fig. 16.

[0032] FIG. 18 is a side plan view of the portable fluid monitoring device of Fig. 17.

[0033] FIG. 19 is a cross-sectional view of the portable fluid monitoring device of Fig. 18 taken at lines 19-19.

[0034] FIG. 20 is a perspective view of the portable fluid monitoring device of Fig. 17 and a funnel device adapted to be attached between the portable device of Fig. 17 and a catheter.

[0035] FIG. 21 is a perspective view of the funnel device of Fig. 20 and a catheter.

[0036] FIG. 22 is perspective view of the funnel device attached to the catheter.

[0037] FIG. 23 is a block diagram of a circuit for a device for monitoring the flow of urine.

[0038] FIG. 24 is a flowchart showing a method of implementing a device of monitoring the flow of a fluid.DETAILED DESCRIPTION

[0039] A more detailed description of the device in accordance with the present disclosure is set forth below. It should be understood that the description of the specific devices below is intended to be exemplary, and not exhaustive of all possible variations or applications. Thus, the scope of the disclosure is not intended to be limiting and should be understood to encompass variations or embodiments that would occur to persons of ordinary skill.

[0040] Turning to FIGS. 1 -4, the figures illustrate examples of a portableAttorney Docket No. 3400-0338.01 (816PCT) urinary catheter monitoring device 10. The monitoring device 10 is a portable, handheld device that is configured to assist with and monitor catheterization. The urinary catheter monitoring device 10 may be associated or operatively in communication with a urinalysis or catheterization monitoring system 12 (shown in FIG. 15), including a urinary catheter 14, such as an intermittent urinary catheter, and a computing device 16. The monitoring device 10 is configured to receive an intermittent urinary catheter 14 and can track a variety of urine flow characteristics including, but not limited to, void volume, void rate, void frequency, and void time. Other catheterization characteristics can be monitored without departing from the scope of the disclosure.

[0041] In general, the monitoring device 10 can include a base 18 including a barrel 20, a flow meter assembly, and a controller 24. Additionally, the base 18, optionally, includes a coupling element 26 configured to receive a portion of an intermittent urinary catheter 14. The flow meter assembly is configured to detect the flow of urine through the barrel 20, either directly ( / .e., urine travels directly through the barrel 20) or indirectly through a portion of a catheter tube 28 that is located within the barrel 20.

[0042] Turning briefly to FIGS. 13 and 14, the figures illustrate examples of intermittent urinary catheters 14 that can be associated with the portable urinary catheter monitoring device 10. The catheters 14 illustrated in FIGS. 13 and 14 may contain similar features. The same reference number will be used to identify similar features in the figures, whereas different features will be identified with a different reference number. In an example, urinary catheter 14 includes a catheter tube 28 having a catheter proximal insertion end 30 and a catheter distal drainage end 32. A lumen extends from the catheter proximal insertion end 30 to the catheter distal drainage end 32. The catheter proximal insertion end 30 includes one or more openings 34 for receiving urine in communication with the lumen. In an example, the one or more openings 34 for receiving urine may be an eyelet. In another example, the one or more openings 34 for receiving urine may be multiple eyelets. The size, shape and location of the one or more openings 34 for receiving urine may vary without departing from the scope of the disclosure.

[0043] The catheter distal drainage end 32 includes a drainage opening for draining urine from the lumen. In an example, the catheter distal drainage end 32Attorney Docket No. 3400-0338.01 (816PCT) includes a drainage member 36. The drainage member 36 may be, for example, but not limited to, a connector or a funnel.

[0044] In some examples, the catheter tube 28 may include a hydrophilic polymer coating on its outer surface. The hydrophilic polymer coating is configured to absorb a hydrating medium to lubricate the catheter tube 28 to aid in insertion into a urethra.

[0045] Optionally, the urinary catheter 14 may include a sleeve 38 and an insertion aid 40 (shown in FIG. 14). The sleeve 38 may be a protective or barrier sleeve. The sleeve 38 has a sleeve proximal end 42 and a sleeve distal end 44. The sleeve 38 may define an internal cavity in which the catheter tube 28 may be located. In an embodiment, the sleeve 38 surrounds at least a portion of the catheter tube 28. In another embodiment, the sleeve 38 extends over and surrounds the length of the catheter tube 28.

[0046] In an example, an insertion aid 40 may be located at the sleeve proximal end 42. When an insertion aid 40 is present, the sleeve proximal end 42 may be attached to a distal portion 41 of the insertion aid 40 by, for example, welding or adhesive. The sleeve distal end 44 may be attached to the drainage member 36 (e.g., connector or funnel) or to a distal portion of the catheter tube 28. The sleeve distal end 44 may be attached to the drainage member 36 or catheter distal drainage end 32 by, for example, welding or adhesive.

[0047] The sleeve 38 may be made of a flexible material which may be vapor permeable or vapor impermeable, depending on the desired use and packaging. The material of the sleeve 38 also may be liquid impermeable or liquid permeable. The sleeve 38 may be formed of any of a variety of thin, flexible polymeric film materials, such as polyethylene, plasticized PVC, or polypropylene, but elastomeric film materials such as polyurethane, and particularly elastomeric hydrogel materials, may be suitable. In some embodiments, the sleeve 38 may contain a hydration medium.

[0048] In some embodiments, the urinary catheter 14 may include a cap 46 (shown in Fig. 14). The cap 46 includes a cavity configured to receive at least a portion of the insertion aid 40. The cap 46 may be attached to the insertion aid 40 via, for example, but not limited to, a friction fit. Additionally, the cap 46 can include a ring 48 configured to be gripped by a user to pull the cap 46 off of theAttorney Docket No. 3400-0338.01 (816PCT) insertion aid 40.

[0049] Turning back to FIGS. 1 -4, as discussed above, the figures show examples of a portable monitoring device 10 with an optional base 18 and a barrel 20. The barrel 20 includes a barrel first end 50 and a barrel second end 52. A channel 54 is defined between the barrel first end 50 and the barrel second end 52. The base 18 can include a top surface 56 and a side wall 58. In an example where a base 18 is included, the bottom of base 18 is associated with the barrel 20. For instance, the bottom of base 18 may be attached to barrel 20 and located on the barrel 20 between the barrel first end 50 and the barrel second end 52.The base 18 can be ergonomically shaped to assist with gripping and handling the device 10. In an example, the base 18 includes an ergonomic gripping portion 60 on the side wall 58. For instance, as shown in FIGS. 1 -4, the gripping portion 60 includes a concave shape. The concave shape of the gripping portion 60 provides a place for a user to hold the portable urinary catheter monitoring device 10 comfortably. A second gripping portion 60 can be located on the opposite portion of the side wall 58. In other examples, the base 18 can include a textured portion on the side wall 58 to assist a user with gripping the base 18. Additionally, the top surface 56 of the base 18 can be flat, allowing a surface on which a user can place their palm when gripping the device 10. Base 18 may also include operation mechanisms or visual indicators, such as buttons, switches, a touchscreen, lights, etc.

[0050] Furthermore, base 18 can house electronic components of the portable urinary catheter monitoring device 10. For example, base 18 can include a power source, such as a replaceable or rechargeable battery. Base 18 can also include the controller 24 as described herein. Additionally, base 18 can, optionally, include portions of the flow meter assembly.

[0051] In an example, as shown in FIGS. 1 -2, the barrel 20 can be partially circumferentially enclosed. For instance, the barrel 20 can be semi-circular or C- shaped. For example, barrel 20 may have a C-shaped cross-section having an opening or space between the barrel’s opposed side walls 61 .

[0052] In another example, as shown in FIGS. 3-4, the barrel 20 can be fully circumferentially enclosed.

[0053] Additionally, the device 10 can include an attachment memberAttorney Docket No. 3400-0338.01 (816PCT) configured to attach the portable urinary catheter monitoring device 10 to a personal mobility device. For instance, the monitoring device 10 can be attached to an armrest or rail of a wheelchair, crutches, a cane, or any other suitable device that assists a user with mobility. In an example, when the barrel 20 is partially circumferentially enclosed, as shown in FIGS. 1 -2, the inner surface 63 of the barrel side wall 61 includes two parallel ridges 62. The ridges 62 are located on opposite locations from one another within the barrel 20 and can extend the entire length of the barrel 20. The barrel side wall 61 extends beyond the ridges 62, forming a “clip-like” structure configured to accept a portion of a personal mobility device. The portions of the barrel side wall 61 extending beyond the ridges 62 can partially surround a portion of a personal mobility device and the ridges 62 define a seat configured to accept a portion of the personal mobility device. Accordingly, the monitoring device 10 can be clipped or slid on to a personal mobility device. For example, the arm or bar of a wheelchair may be received into the opening between barrel side walls 61 , wherein in the tolerances between the wheelchair arm and the side walls 61 are such that side walls releasably attach to the arm by friction or snap fit. In some alternatives, the side walls 61 may have some elasticity and flex to fit over the arm.

[0054] The type of attachment member and its location on the device can vary without departing from the scope of the disclosure. For example, other suitable attachment members can include a clip, a clasp, an adhesive, a clamp, or any other suitable temporary attachment members for attaching the device to a personal mobility device.

[0055] The barrel 20 can optionally include a coupling element 26 located at or near the barrel second end 52. In particular, the coupling element 26 is located within the channel 54 defined by the barrel 20 at or near the barrel second end 52. The coupling element 26 is configured to receive a portion of an intermittent urinary catheter 14. In an example, the coupling element 26 is a clip that is configured to receive a portion of the intermittent urinary catheter 14. For instance, the clip can receive a portion of the urinary catheter tube 28. In another example, the clip can receive a drainage member 36 located at the distal end 32 of the urinary catheter tube 28.

[0056] Additionally, the barrel 20 includes a flow meter assembly configured toAttorney Docket No. 3400-0338.01 (816PCT) detect flow of urine through the channel 54. In particular, the flow meter assembly can include an electromagnetic sensor 70 (shown in FIGS. 8A, 8B, and 9), a Halleffect flowmeter 80 (shown in FIGS. 10A and 10B), or a thermal flow sensor 90 (shown in FIGS. 11 -12). The barrel 20 can include other suitable flow meter assemblies configured to detect flow parameters without departing from the scope of the disclosure.

[0057] FIGS. 5-7, illustrate examples of an intermittent urinary catheter 14 attached to the portable urinary catheter monitoring device 10. In an example, as shown in FIG. 5, the intermittent urinary catheter 14 is attached to a catheter monitoring device 10 including a partially circumferentially enclosed barrel 20. In other words, the barrel side wall 61 includes a gap. In this instance, when the portable urinary catheter monitoring device 10 includes a partially enclosed barrel 20, the device 10 is configured to detect flow of urine through a catheter tube 28. To detect the flow of urine through a catheter tube 28, the channel 54 defined by the barrel 20 is configured to receive a portion of the intermittent urinary catheter 14. In particular, the coupling element 26 within the channel 54 is configured to be coupled to a portion of the intermittent urinary catheter 14. In an example, the coupling element 26 can be coupled at any location of the catheter tube 28 outside of the body. For example, the coupling element 26 can be coupled to the distal end 32 of the catheter tube 28 such that the drainage end of the catheter tube 28 is located near the barrel second end 52 and a portion of the catheter tube 28 extending towards the proximal insertion end 30 is located within the channel 54. Alternatively, the drainage member 36 can be coupled to the coupling element 26 near the barrel second end 52 and a portion of the catheter tube 28 extending towards the proximal insertion end 30 is located within the channel 54. As urine flows through the catheter tube 28 from the proximal insertion end 30, the urine will travel through the portion of the tube within the channel 54, and can be emptied through the distal drainage end located at or near the barrel second end 52. Accordingly, during use, the second end 52 of the device 10 can be tilted or directed towards a suitable waste receptacle (e.g., a toilet, collection bag, etc.) such that urine exits the distal drainage end 32 of the catheter 14 into the receptacle.

[0058] Turning to FIGS. 6 and 7, the figures illustrate examples of a urinaryAttorney Docket No. 3400-0338.01 (816PCT) catheter 14 attached to a catheter monitoring device 10 including a fully circumferentially enclosed barrel portion 20. The fully circumferentially enclosed barrel 20 is configured to receive a portion of the intermittent urinary catheter 14. In particular, the coupling element 26 within the channel 54 is configured to be coupled to a portion of the intermittent urinary catheter 14. In an example, as shown in FIG. 6, the catheter tube 28 can be inserted through the barrel second end 52 and fed through the barrel 20 such that the proximal insertion end 30 of the catheter tube 28 extends beyond the barrel first end 50. The distal end 32 of the catheter tube 28 or the drainage member 36 can be coupled to the coupling element 26. As urine flows through the catheter tube 28 from the proximal insertion end 30, the urine will travel through a portion of the catheter tube 28 located within the channel 54, and can be emptied through the distal drainage end 32 located at or near the barrel second end 52. Accordingly, during use, the second end 52 of the device 10 can be tilted or directed towards a suitable waste receptacle (e.g., a toilet, collection bag, etc.) such that urine exits the distal drainage end 32 of the catheter 14 into the receptacle.

[0059] In another example, as shown in FIG. 7, the monitoring device 10 is configured to detect urine flowing directly within the channel 54. In this instance, the distal drainage end 32 of catheter tube 28 can be inserted into the channel 54 at the barrel second end 52 near the coupling element 26. The distal drainage end 32 of the catheter tube 28 or the drainage member 36 can then be coupled to the coupling element 26. By coupling the distal drainage end 32 or drainage member 36 to the coupling element 26 in this manner, urine flowing from the proximal insertion end 30 of the catheter tube 28 will flow to the distal drainage end 32 and exit the catheter 14 into the channel 54 defined by the fully circumferentially enclosed barrel 20. Urine can then exit the channel 54 through the barrel first end 50. In an example, the barrel 20 can include a leak protector between the barrel second end 52 and a flow meter assembly located within the channel 54 to prevent urine from leaking out of the barrel second end 52 after the urinary catheter 14 has been connected and inserted into a bladder. In particular, a leak protector can be located at the flow meter assembly within the channel 54. For instance, the leak protector can be an O-ring, a polymer diaphragm, or any other suitable leak protector. Accordingly, during use, the barrel first end 50 of theAttorney Docket No. 3400-0338.01 (816PCT) device 10 can be tilted or directed towards a suitable waste receptacle (e.g., a toilet) such that urine exits the channel 54 into the receptacle.

[0060] The catheter 14 can be attached to the device 10 in other ways without departing from the scope of the disclosure. For instance, in another example, the proximal insertion end 30 of the catheter tube 28 can be inserted through the barrel first end 50. The catheter tube 28 can be pushed or pulled through the barrel 20 until the distal drainage end 32 or drainage member 36 reach the coupling element 26 near the barrel second end 52. The distal drainage end 32 or the drainage member 36 can then be coupled to the coupling element 26. Additionally, the catheter distal drainage end 32 or drainage member 36 can be coupled to the device 10 via a push-fit, friction-fit, or other suitable coupling connection.

[0061] In an example, the flow meter assembly of the monitoring device 10 can be an electromagnetic sensor 70 as shown in FIGS. 8A, 8B, and 9. The electromagnetic sensor 70 includes a sensor core 72 including a hole 74 defining a flow path for flow of fluid through the core 72. The sensor core 72 also includes a pair of windings 76 and electrodes 78. In particular, the sensor core 72 includes an electrode 78 located at the top and the bottom of the core 72 and windings 76 located at the right and left sides of the core 72. A copper coil can be wound around the windings 76. As such, the electrodes 78 and windings 76 are located perpendicular to one another such that when the windings 76 have an alternating current flowing through them, a magnetic field across the core hole 74 is produced. For instance, a magnetic field is produced from left to right and from right to left as per the excitation cycle.

[0062] The inner surface of the core 72 can include a shieldi ng / l iner layer to prevent magnetic field interference with electronic circuits. The shielding layer may be made from, for example, PTFE and PFA while the electrodes 78 may be made from SS 304 stainless steel or any other suitable material. As shown in FIG. 8A, the core 72 can be housed within a frame 79 and the frame 79 including the core 72 can be located within the channel 54 of the device 10 (as shown in FIG. 9). In an example, the frame 79 includes the controller 24 and is configured to record flow data and to send the data to a computing device.

[0063] The electromagnetic sensor assembly 70 can be used to detect urineAttorney Docket No. 3400-0338.01 (816PCT) flowing through a portion of the catheter tube 28 located withing the channel 54 of the device 10 or to detect urine flowing directly through the channel 54 (i.e., urine emptied from the catheter 14 into the channel 54). To detect the flow of urine through the catheter 14, the catheter 14 can be attached to device 10 as shown in FIG. 6. In particular, proximal insertion end 30 of the catheter tube 28 can be inserted through the core hole 74 of the electromagnetic sensor 70 within the channel 54 such that the distal end 32 of the catheter tube 28 is located near the coupling element 26 at the barrel second end 52. The proximal insertion end 30 of the catheter tube 28 extends beyond the barrel first end 50. The distal end 32 of the catheter tube 28 or the drainage member 36 can then be attached to the coupling element 26. After coupling the intermittent urinary catheter 14 to the monitoring device 10, the user can insert the proximal insertion end 30 of the catheter tube 28 through the urethra and into their bladder to drain urine therefrom. When urine, an electric conductor, flows through the magnetic field (as it flows through the portion of catheter tube 28 in the core 72), a voltage is generated that is picked up by the electrodes 78 in accordance with Faraday’s law. The voltage produced is proportional to flow rate. The voltage signal can be processed by the controller 24 through signal conditioning algorithms to determine flow parameters such as void volume void rate, void frequency, and void time.

[0064] The catheter 14 can also be attached to the device 10 such that urine exits the catheter 14 and flows directly through the device channel 54, as shown in FIG. 7. In particular, urine can flow directly through the core hole 74 and the electromagnetic sensor assembly 70 is configured to detect urine flow through the core 72. To attach the catheter 14 to the device 10 to flow urine through the channel 54, the distal drainage end 32 of catheter tube 28 is inserted into the channel 54 at the barrel second end 52 near the coupling element 26. The distal drainage end 32 or drainage member 36 can abut the core 72 such that the drainage outlet of the catheter 14 aligns with the core hole 74. The distal drainage end 32 or the drainage member 36 can then be coupled to the coupling element 26. By coupling the distal drainage end 32 or drainage member 36 to the coupling element 26 in this manner, urine flowing from the proximal insertion end 30 will flow to the distal drainage end 32 and into the channel 54 defined by the fully circumferentially enclosed barrel 20. Urine can then exit the channel 54 throughAttorney Docket No. 3400-0338.01 (816PCT) the barrel first end 50. In an example, the barrel 20 can include a leak protector between the barrel second end 52 and core 72 to prevent urine from leaking out of the barrel second end 52 after the urinary catheter 14 has been connected and inserted into a bladder. In particular, a leak protector can be located at the core 72. For instance, the leak protector can be an O-ring, a polymer diaphragm, or any other suitable leak protector.

[0065] In another example, the flow meter assembly can be a Hall-effect flowmeter 80, as illustrated in FIGS. 10A and 10B. In particular, the Hall-effect flowmeter can be used to detect urine flow through a device 10 including a fully circumferentially enclosed barrel portion 20. The Hall-effect flowmeter 80 includes an impeller 82 fitted with a magnet 84 on one of the blades 83 and a sensor 86 configured to detect the magnet 84. In an example, a portion of the impeller 82 is placed within the channel 54 such that as urine flows through the channel 54, the impeller 82 rotates. In particular, as illustrated in FIG. 10A, the impeller 82 extends about halfway into the channel 54. As urine flowing within the channel 54 contacts the blades 83 of the impeller 82, the impeller rotates and the magnet 84 on the impeller 82 triggers the sensor 86 for every rotation.

[0066] Alternatively, the Hall-effect flowmeter 80 can include a turbine 85, as illustrated in FIG. 10B. Turbine 85 is configured to rotate about a central axis 89 extending through the channel 54. Additionally, turbine 85 can be located entirely within channel 54. Similar to the impeller 82 described herein, the turbine 85 includes a magnet on one of the blades 87 and a sensor 86 configured to detect the magnet. As urine flowing within the channel 54 contacts the blades 87 of the turbine 85, the turbine 85 rotates about axis 89 and the magnet on the turbine 85 triggers the sensor 86 for every rotation.

[0067] The Hall-effect flowmeter 80 works on the principle of Faraday’s Law of Electromagnetic Induction. In particular, a changing magnetic flux will induce a voltage opposite to the magnitude of the flux. Accordingly, the voltage produced is proportional to the flow rate. The voltage signal can be processed by the controller 24 through signal conditioning algorithms to determine flow parameters such as void volume, void rate, void frequency and void time.

[0068] Turning to FIGS. 11 -12, in another example, the flow meter assembly of the monitoring device 10 can be a thermal flow sensor 90. The thermal flowAttorney Docket No. 3400-0338.01 (816PCT) sensor 90 includes a first thermocouple 92, a second thermocouple 94, and a heating element 96. As shown in FIGS. 11 -12, the thermal flow sensor 90 is located in the barrel 20. In particular, the first thermocouple 92, the second thermocouple 94, and the heating element 96 are located on the barrel inner surface 63. In an example, the thermal flow sensor 90 can be attached to the barrel inner surface 63. Alternatively, the thermal flow sensor 90 can be incorporated in the barrel 20, for example, the thermal flow sensor 90 can be embedded in the barrel inner surface 63. In an example, the first thermocouple 92 is located closer to the barrel first end 50, the second thermocouple 94 is located closer to the barrel second end 52, and the heating element 96 is located between the first and second thermocouples 92 and 94. Additionally, the first thermocouple 92 and the second thermocouple 94 are located equidistant from the heating element 96.

[0069] The thermal sensor 90 is configured to record flow data by heating urine flowing through the channel 54 and taking temperature readings of the urine. In general, the heating element 96 heats up a local area to heat fluid traveling through the channel 54 and raises its temperature. The first and second thermocouples 92 and 94 can detect pre-heat and post-heat temperatures, respectively. It will be understood that depending on the orientation of the catheter 14 associated with the device 10, in the direction of flow, the upstream thermocouple will be configured to detect a pre-heat temperature and the downstream thermocouple will be configured to detect a post-heat temperature.

[0070] In an example, the thermal sensor 90 can be used to detect urine flow through a portion of the catheter tube 28 located within the channel 54 of device 10. For instance, to detect the flow of urine through a portion of the catheter tube 28, the intermittent urinary catheter 14 can be attached to the device 10, as shown in FIG. 12 (including a partially enclosed barrel portion 20) or to a device 10 including a fully enclosed barrel portion 20. In particular, the catheter 14 can be attached to device 10 as described and shown in FIGS. 5 and 6. For instance, the distal drainage end 32 of the catheter tube 28 or a drainage member 36 can be attached to the coupling element 26 and the proximal insertion end 30 of the catheter tube 28 can extend beyond the barrel first end 50. After coupling the intermittent urinary catheter 14 to the monitoring device 10, the user can insert theAttorney Docket No. 3400-0338.01 (816PCT) proximal insertion end 30 of the catheter tube 28 through the urethra and into their bladder to drain urine therefrom. When urine flows through the catheter 14, the heating element heats the local area of the catheter tube 28 equally around it. The first thermocouple 92 is configured to record a pre-heat temperature of the urine as it flows from the proximal insertion end 30 towards the distal drainage end 32. As the temperature of the urine is raised, the flow of the urine shifts the heating zone towards the second thermocouple 94, which is configured to record a postheat temperature of the urine after it has travelled past the first thermocouple 92 and heating element 96. This shift in temperature zone results in differential temperature reading. In an example, the higher the flow, the lower the temperature differential will be. This differential can be processed by the controller 24 using signal conditioning algorithms to determine flow parameters such as void volume, void rate, void frequency, and void time.

[0071] In another example, the thermal sensor 90 can be used to detect urine flow directly through the channel 54 ( / .e., the device 10 includes a fully circumferentially enclosed barrel portion 20). In this instance, the intermittent urinary catheter 14 can be attached to the device 10 as described and shown in FIG. 7. Due to the orientation of flow from the barrel second end 52 to the barrel first end 50, the second thermocouple 94 is configured to record a pre-heat temperature. As the temperature of the urine is raised, the flow of the urine shifts the heating zone towards the first thermocouple 92, which is configured to record a post-heat temperature of the urine after it has travelled past the second thermocouple 94 and heating element 96. This shift in temperature zone results in differential temperature reading. In an example, the higher the flow, the lower the temperature differential will be. This differential can be processed by the controller 24 through signal conditioning algorithms to determine flow parameters such as void volume, void rate, void frequency, and void time.

[0072] Turning to FIG. 15, the monitoring device 10 is configured to be associated with a health monitoring system, for example, a catheterization monitoring system 12. FIG. 15 illustrates an exemplary monitoring system 12, which includes the portable monitoring device 10. Optionally, the system also includes a computing device 16, such as, but not limited to, a mobile phone, smartphone, tablet, smartwatch, laptop, or computer. The monitoring device 10Attorney Docket No. 3400-0338.01 (816PCT) can be used to monitor data, including, but not limited to flow characteristics such as void volume, void rate, void frequency, and void time. Other catheterization statistics can be monitored without departing from the scope of the disclosure.

[0073] For the purpose of establishing effective communication between the user (or environment) and the monitoring system 12, the base 18 of monitoring device 10 houses a controller 24 and one or more interfaces associated with the controller 24. For example, the controller 24 may include at least two interfaces, a first interface (device interface) and a second interface (transmission interface). The first interface is configured to provide an input channel to capture catheterization data from the user. The second interface is configured to provide an output channel establishing communication between the monitoring device 10 and the external computing device 16, and optionally, directly with a server 100 via a network 102 associated with the monitoring system 12. The first interface can be coupled to the flow meter assembly, whereas the second interface can be coupled to a transceiver module. In an embodiment, the first and second interfaces may be coupled with controller 24, flow meter assembly, and / or the transceiver module with circuitry.

[0074] The monitoring device 10 is configured for wireless communication via primary connection 104 with the computing device 16. Accordingly, the catheterization data recorded by monitoring device 10 can be transmitted to computing device 16 via primary connection 104. Additionally, the computing device 16 is configured to communicate with a server 100 of the monitoring system 12 via a network 102, such as a cloud-based network. The computing device 16 may be wirelessly connected to server 100 via computing device connection 106. The server 100 may be operated and / or controlled by the catheter manufacturer and / or a service center.

[0075] In an example, the data recorded by the flow meter assembly can be pushed automatically, via primary connection 104 without the need for manual intervention to computing device 16. The data may then be accessed by the user on the computing device 16 and / or further transmitted to the server 100 via computing device connection 106 and server connection 108.

[0076] Optionally, the data may be transmitted directly to the server 100 via network 102. For instance, the data may be transmitted to the network 102 via aAttorney Docket No. 3400-0338.01 (816PCT) monitoring device connection 110 and may then be further transmitted to the server 100 via server connection 108.

[0077] The controller 24 further includes the hardware and the firmware that, with the support of program memory and random-access memory (RAM), communicates with the flow meter assembly, receives the catheterization data, processes the catheterization data, stores the processed data in memory, and communicates with a transmitter or directly to the database server system via the computing device 16. The memory may store the processed data until successful transmission of the data to the external computing device 16 is confirmed.

[0078] The transceiver module provides communication between the monitoring device 10 to the external computing device 16 and / or directly with the server 100. The transceiver module may be configured to transmit and receive data via connections such as Wi-Fi®, Ethernet, Bluetooth®, NFC, RFID, fiber optics, cellular, infrared or other optical communications, or the like. In various examples, the transceiver module may be embedded with a memory, a controlling unit, and antenna. In an embodiment, the transceiver module receives the data from the flow meter assembly and records the data in the memory for further processing by the controller 24. The controller 24 then may generate a transmission signal embedded with the catheterization data to be transmitted to the external computing device 16.

[0079] Other devices, systems, or means for connection / communication between monitoring device 10 and other devices or computing devices are also possible. For example, monitoring device 10 may include a USB port, and / or may be tethered to a device or computer through a wired connection. Alternatively, monitoring device 10 may include a wireless transmitter or transceiver (e.g., Zigbee, etc.) to transmit data wirelessly. In one embodiment, short range radiofrequency (RF) principles may be used. Some short range RF protocols that can be used are referred to as “Bluetooth.” Wireless 802.11 communication principles and / or similar communication principles may also be used. Monitoring device 10 or the computing device 16 with which the monitoring device 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 computing devices connected to the network.Attorney Docket No. 3400-0338.01 (816PCT)

[0080] The external computing device 16 is equipped with an algorithm such as a mobile app to convert the catheterization monitoring data to meaningful information. For example, the computing device 16 can process the catheterization data, reprocess the data, store the data, retrieve analyzed data, and / or generate reports. In particular, computing device 16 can show catheterization data, such as the void volume, void rate, void frequency, and / or void time. The app can also receive the recorded data and is configured to generate a digital bladder diary entry after every catheterization. Machine learning algorithms can be used to analyze this bladder diary to generate insights and trends on user’s health. In an example, in addition to accessing data via the app, the user can also access educational content such as instructional videos or other resources to learn more about potential risk factors associated with catheterization and methods to regulate them.

[0081] In other examples, catheterization data are transmitted to the server 100. In another example, the transceiver module transmits raw data to a cloud network 102 and / or server 100, or another device.

[0082] Additionally, it should be noted that various methods and operations are described as being executed by the controller 24 in the monitoring device 10 as primarily executing digitized analog signals and processing the digitized data to a format which is ready to be transmitted to external computing devices. 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 monitoring device 10. Discussions of a particular processing element are meant as illustrative only.

[0083] In an example, the monitoring device 10 / controller 24 is optionally configured to, in accordance with a determination that the primary connection 104 fails to establish, abort transmitting the catheterization data to the computing device 16 and establish a secondary connection to the server 100, wherein the catheterization data is transmitted via the monitoring device connection 1 10 to network 102, and from network 102 to server 100 via server connection 108. Establishing a secondary connection may comprise activating an idle or inactive secondary connection.

[0084] Monitoring device 10 or the computing device 16 with which theAttorney Docket No. 3400-0338.01 (816PCT) monitoring device 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 computing devices connected to the network which is accessible at the healthcare provider end.

[0085] The data transmitted to the computing device 16 and / or server 100 may be used to record flow characteristics, catheterizations, and / or urinary tract health of the user and / or warn the user of changes or risks with their urinary tract health. For example, the computing device 16 may have software that analyzes the data and provides notifications when certain parameters are detected. Furthermore, these notifications may be provided to a healthcare provider 112 via a healthcare provider connection 114 to server 100. Additionally, the data may be accessed from the computing device 16 or server 100 for a healthcare provider 1 12 to review. In an example, a healthcare provider 112 may be able to access data from either the portable monitoring device 10 or the computing device 16 to monitor how frequently a user is catheterizing and / or how much urine is drained during each catheterization. In response, the healthcare provider 112 may be able to send a notification to the user’s computing device 16 or monitoring device 10.

[0086] Figs. 16 through 24 describe devices for monitoring a fluid, such as urine passing through a catheter. Patients who use catheters have no access to information of their urethral / blader health on a day-to-day basis leading. Among other concerns, a person needing to use a catheter may have a fear of consequences of inserting a catheter and trauma in the long term, a lack of control over driving their health outcome, and feeling isolated due to lack of information and an overreliance on their clinician for any information. These three issues are at the core of the problem knowledge deficit and poor understanding of urinary tract infection (UTI) risk factors. Patients may not often keep an up-to-date record of their blader voiding because of poor compliance due to various reasons. This gap in data deems this tracking an unreliable tool in most cases for clinicians. Maintaining a record of every void activity is a cumbersome process, especially for long term users. This perception of maintaining a bladder diary as additional work is one of the biggest reasons for this poor compliance. The circuits and devices described below make it easier for a user to monitor and track conditions, including UTI infections.Attorney Docket No. 3400-0338.01 (816PCT)

[0087] Turning first to Fig. 16, a cross-sectional view of a fluid monitoring device 1601 , which may monitor urine flow in a catheter for example, is shown. More particularly, a primary path 1602 comprises a first portion 1604 extending from a first end 1606 of the primary path to a second end 1608 of a second portion 1610 of the primary path. A portion 1612 of the primary pathway 1602 between the first end 1606 and the second end 1608 is in fluidic communication with a shunt path 1616 extending from a first opening 1614 allowing fluid to flow through a first branch portion 1616 to a fluid monitoring portion 1618. As will be described in more detail below, various circuit elements associated with the fluid monitoring portion allow for the monitoring of characteristics of a fluid, such as urine. The fluid monitoring portion extends to a second branch portion 1620, where the fluid exits at a second opening 1622 back into the primary path.

[0088] The fluid monitoring circuit 1623 associated with the fluid monitoring portion 1618 may comprise a first capacitor plate 1624 on a side of the fluid monitoring portion and a second capacitor plate 1626 on a second side of the fluid monitoring portion as shown in Fig. 16. Although the parallel capacitor plates are shown by way of example, it should be understood that other arrangements of capacitive elements may be implemented, such as an arrangement of coaxial capacitive elements, where a first coaxial capacitive element may be placed inside the test portion and a second coaxial capacitive element may be placed outside of the fluid monitoring portion. The first capacitor plate 1624 and the second capacitor plate 1626 are electrically coupled to a control circuit 1628 by way of wires 1632 and 1634, respectively.

[0089] The design of the shunt path is based upon principles of microfluidics, where a small shunt path is used to wick a flow out from the main flow path. By creating the shunt path, it is possible to reduce turbulence and noise and get a more steady and consistent flow through the test portion. According to some implementations, the diameter d1 may be approximately 3 mm to 7 mm and the diameter d2 may be approximately 1 .2 mm to 1 .5 mm. In an example, the diameter d1 may be any suitable diameter between 3 mm and 7mm, including 3 mm and 7mm, and the diameter d2 may be any suitable diameter between 1 .2 mm and 1 .5 mm, including 1 .2 mm and 1 .5 mm. According to some implementations, the fluid monitoring portion 1618 may extend approximately 7.5Attorney Docket No. 3400-0338.01 (816PCT) mm. In an example, the fluid monitoring portion 1618 may extend 7.5 mm. While the capacitor is associated with the shunt path, it should be understood that the capacitor could be implemented in the primary path.

[0090] A first electrode 1636 and a second electrode 1638 may also be provided within the fluid monitoring device and coupled to the control circuit 1628 by wires 1640 and 1642, respectively. According to some implementations, the electrodes may be provided in the fluid monitoring portion as shown. A tighter gap between the two electrodes, such as by placing them within the fluid monitoring portion 1618 may also reduce the noise in the signal and improve the signal strength. The determination of qualities of the fluid using the capacitor and the electrodes will be described in more detail below.

[0091] According to one implementation, capacitor plates may be used to monitor the flow of urine in the fluid monitoring device. When the capacitor is supplied by a constant voltage source, a current will be generated in the capacitor, where the value of this current is linearly proportional to the volumetric flow rate of fluid flowing inside the capacitor. Energy supplied by the voltage source is equal to the convection of electrical energy according to the following equations:Equation 1Equation 2where I = current, V = voltage applied, c = permittivity of media, d = distance between plates, and Q = volumetric flow rate. Therefore, by measuring the current, the volumetric flow rate inside the capacitor can be determined. Thus, by integrating flow rate over time, void volume, void time, and void / usage frequency can be calculated.

[0092] The first electrode 1636 and the second electrode 1638 enable the detection of characteristics of the fluid such as urine passing through the monitoring portion. One characteristic of the fluid that could be detected by the electrodes is conductivity. Conductivity of the fluid is a non-linear function of electrolyte concentration in the fluid. Conductivity may be used as an indirect method to determine the feasibility of a urine conductivity measurement, and may be directly proportional to different kidney functions. When kidney function isAttorney Docket No. 3400-0338.01 (816PCT) normal, the filtration rate of the glomeruli in the kidneys is higher, resulting in higher conductivity. However, when kidney function is abnormal, the filtration rate is lower, leading to lower conductivity. Conductivity is related to the concentration of electrolytes such as sodium and uric acid. Urine conductivity has a positive correlation with osmolality and specific gravity. Urine osmolality and conductivity levels can also be used to interpret the concentration of uncharged glucose molecules.

[0093] More particularly, osmolality is a measure of amount of solute content in the solution. A higher solute content would mean, higher proportion of solute (out of solution). In other words, this would mean that the solution volume has gone down, indicating dehydration. Higher solute concentration will have higher resistance to the flow of current. Therefore, urine osmolality is used as a way to know the level of hydration. When someone is dehydrated, they will have a higher osmolality and vice versa, as described in Table 1 below.Attorney Docket No. 3400-0338.01 (816PCT)Table 1

[0094] If intermittent catheter users are at risk for complex hydration issues (e.g., those with kidney disease, diabetes, or other medical conditions), urine osmolality is more accurate. It directly measures the solute concentration in the urine, making it a more reliable indicator of true hydration status. Osmolality is particularly useful in a clinical setting where lab facilities are available and precision is necessary. Urine osmolality is useful for more precise or clinical monitoring, especially in cases where more detailed information about solute concentration is needed (e.g., in the presence of kidney disease or other medical conditions).

[0095] According to some implementations, the fluid monitoring device may comprise a smart attachment module equipped with the sensing assembly embedded in the surface around a flow path and adapted to be axially attached to a funnel of a catheter. The fluid monitoring device can be part of a portable device that connects to the catheter during catheterization, as shown for example in Figs. 17-22.

[0096] Turning first to Fig. 17, a perspective view of a portable fluid monitoring device adapted to contain the elements of the device of Fig. 16 is shown is shown. The fluid monitoring device 1701 may include a tube 1702 made from any suitable material, such as an elastomeric material. The material may be, for example a polyolefin. In other embodiments, tube 1702 may be a rigid tube made from a rigid material. The fluid monitoring device 1701 may extend from a proximal end 1704 having a coupling interface 1706 to an outlet 1708. As will be described in more detail below, the proximal end 1704 may be connected to a drainage member and the outlet 1708 may be connected to a collection bag. The tube 1702 comprises a housing portion 1710 for enclosing the shunt path 1616, as will be shown in Fig. 19. The fluid monitoring device may also comprise a userAttorney Docket No. 3400-0338.01 (816PCT) interface 1712, as will be described in more detail in reference to Fig. 23. The features of the portable fluid monitoring device of Fig. 17 are shown in the side plan view of Fig. 18.

[0097] Turning now to Fig. 19, a cross-sectional view of the portable fluid monitoring device of Fig. 18 taken at lines 19-19 is shown. The elements of Fig.16 can be seen in the cross-sectional view of Fig. 19, where the circuits for monitoring the flow of a fluid are shown in the housing portion 1710. The user interface 1712 may be associated with the control circuit 1628 as shown. While the arrangement of the elements of Fig. 16 are shown positioned in the portable fluid monitoring device of Fig. 17 by way of example, it should be understood that the elements of Fig. 16 may be implemented in a different portable device than that shown in Figs. 17-19, or the elements of Fig. 16 may be arranged in a different manner in the portable fluid monitoring device of Figs. 17-19.

[0098] Turning now to Fig. 20, a perspective view of the portable device of Fig.17 and a funnel device 2002 adapted to be attached between the portable device and a catheter, as will be described in more detail in reference to Fig. 22, is shown. According to some implementations, the funnel device attaches to the catheter with either a twist lock, or a push fit assembly, as will be describe in reference to Figs. 21 and 22.

[0099] When portable fluid monitoring device 1701 is in use with the funnel device 2002 and a catheter, the portable fluid monitoring device 1701 connects with the funnel device 2002 and the catheter in a cascaded arrangement such that channels of the portable fluid monitoring device 1701 and the funnel device 2002 are aligned with the catheter lumen extending within the catheter to form a mutual passage, providing a fluidic communication therethrough and thereby allowing urine to flow through the mutual passage. Outlet 1708 is configured for draining urine into a toilet or collection bag.

[0100] The proximal end 1704 of portable fluid monitoring device 1701 defines a coupling interface 1706. As exemplified, the coupling mechanism is adapted to attach portable fluid monitoring device 1701 to funnel device 2002, with the contacting surfaces of the portable fluid monitoring device 1701 and the funnel device 2002 forming a liquid-tight seal between the two. The seal will prevent urinary fluid leakage during catheterization. As exemplified, the couplingAttorney Docket No. 3400-0338.01 (816PCT) mechanism is moveable between an engaging and disengaging position. In one alternative, the structure of the locking mechanism includes the coupling interface 1706 (e.g., a slot or hole) at the proximal end 1704 of the portable fluid monitoring device 1701 , configured to engage with a latching interface 2006 (e.g., another slot or hole sized and shaped to complementarily accommodate the coupling interface 1706) formed at an end 2004 of the funnel device 2002.

[0101] Engaging the coupling interface 1706 with the latching interface 2006 secures the portable fluid monitoring device 1701 and the funnel device 2002 to enable fluidic communication. The coupling mechanism is adapted to mechanically and releasably couple the portable fluid monitoring device 1701 with funnel device 2002 or de-couple the portable fluid monitoring device 1701 from funnel device 2002. Specifically, the coupling mechanism may be transitioned between a latched state configured to restrict the movement of the coupling interface 1706 relative to the latching interface 2006, and an unlatched state configured to allow the movement of the coupling interface 1706 relative to the latching interface 2006. In this alternative, the locking mechanism is a twist lock, achieved through rotational engagement between the coupling interface 1706 and a corresponding latching interface 2006, securing the two components via a twisting motion. In other alternatives, the locking mechanism may be achieved by push fit lock, snap fit lock, or the like.

[0102] Turning now to Fig. 21 , a perspective view of the funnel device 2002 of Fig. 20 and a catheter 2102 having a coupling end 2104 comprising a latching element 2106. The funnel device 2002 includes a wall having an indentation 2008. The indentation 2008 may be formed when the wall is being shaped or may be carved out from the wall of an already formed drainage member housing. For example, indentation 2008 may be cut or carved out of the outer surface of the wall of the proximal end 2010 of the funnel device. The carving of indentation 2008 may be performed via laser cutting, lithography, or any other suitable cutting method. In another alternative, when the funnel device is made by injection molding, indentation 2008 is formed during the molding process.

[0103] The opening in the proximal end 2010 of funnel device 2002 receives catheter coupling end 2104 to attach funnel device 2002 to catheter 2102. Funnel device 2002 connects with catheter 2102 in a cascaded arrangement such that aAttorney Docket No. 3400-0338.01 (816PCT) channel of the funnel device and the lumen of the catheter are aligned to form a mutual passage, providing a fluidic communication therethrough and thereby allowing urine to flow through the mutual passage. As exemplified, engaging catheter 2102 to funnel device 2002 may be achieved by inserting the coupling end 2104 of catheter 2102 into the inlet opening at the proximal end 2010 of funnel device 2002, where the contours of their contacting surfaces are complementary. The funnel device 2002 and catheter 2102 may be connected by adhesive, melting, welding, or any other suitable connection method. This ensures a tight, leak-proof connection between the two components.

[0104] Turning now to Fig. 22, a perspective view of the funnel device 2002 attached to the catheter 2102 is shown. The catheter extends from the funnel device to a proximal end 2204. One or more eyelets 2206 enable the urine to pass through the catheter and the funnel device to the the portable fluid monitoring device 1701 . Funnel device 2002 may be a funnel, connector that connects to a collection bag, or any external device associated with an intermittent urinary catheter. The catheter may be a disposable single-use catheter or a reusable multiple-use catheter. As exemplified, the funnel device 2002 may be a reusable multiple-use funnel. Funnel device 2002 may be a flexible housing made from any suitable material, such as an elastomeric material. The material may be, for example, a polyolefin. During catheterization, the user advances catheter 2102 through the urethra until its proximal end 2204 enters the bladder. Urine then flows into one or more openings or eyelets 2206 adjacent to and / or in the proximal end 2204 and proximally through the catheter lumen.

[0105] It should be noted that the fluid monitoring device 1701 is reusable. As the capacitor plates never makes contact with flowing fluid, the device can be sterilized and reused. The device can be sterilized by cleaning it with running water or lukewarm water. The device may send data automatically to a smartphone or any such device connected with either a Bluetooth or NFC transceiver or to a cloud where it is analyzed to provide the user with insights on void data and bladder health. In the event when a user feels that they have somehow contaminated the catheter and want to use the next one, they can just use another catheter. After the catheterization, the user may access data regarding catheterization via a computing device, such as via an appon aAttorney Docket No. 3400-0338.01 (816PCT) smartphone. For example, when the user / care giver has access to their phone, they may see a prompt on an app with their latest readings.

[0106] Turning now to Fig. 23, a block diagram of a circuit 2301 for a device for monitoring the flow of urine is shown. The circuit comprises a voltage regulator 2302, which may be a step down circuit for example, the operation of which may be controlled by an on / off switch 2304. The voltage regulator 2302 provides a regulated voltage to a plurality of elements including a capacitance sensor 2306 which provides a current value to a signal conditioning circuit 2308. The capacitor plates 1624 and 1626 may be implemented as the capacitance sensor 2306.

[0107] The signal conditioning circuit comprises a current-to-voltage capacitor 2310 adapted to generate a voltage based upon the current value received from the capacitance sensor, the output of which is routed to an amplifier 2312 and a bandpass filter 2314. The output of the bandpass filter is routed to an analog-to- digital converter 2316.

[0108] The signal generated by the signal conditioning circuit is routed to a control circuit 2318, which controls the application of a signal to be transmitted to a remote device or system. The control circuit 2318 may comprise a processor, such as a central processing unit (CPU), a graphics processing unit (GPU), a digital signal processor (DSP), an application-specific integrated circuit (ASIC), a system on a chip, a field programmable device, such as a programmable logic device (PLD) or field programmable gate array (FPGA), or a combination of two or more of these devices .

[0109] The control circuit may also comprise a memory that may also store data that is processed according to a method of managing account transactions and displayed to a user on a display of the communication device. The memory elements may be fixed or removable. Examples of memory elements include random access memory (RAM) and read-only memory (ROM) as is commonly used in mobile devices, and may be implemented using solid state devices (SSDs), flash memory, embedded multimedia cards (eMMCs), or any other type of memory device.

[0110] The wireless communication circuit 2320 may comprises one or more circuits enabling a wireless communication link, such as WIFI, Bluetooth, or NFC for example, or any other suitable communication protocol including a proprietyAttorney Docket No. 3400-0338.01 (816PCT) communication protocol. While wireless communication protocols are shown by way of example, it should be understood that wired communication protocols could also be used, such as by way of a USB connector for example.

[0111] A variety of circuit elements are provided to control power used by a device for monitoring the flow of urine. More particularly, a battery 2322 is provided, and is coupled to a battery system checker 2324 which provides a signal to a battery status indicator 2326, which may be an LED for example. According to some implementations, the LED may be an RGB LED to be able to provide different colors for indicating different states of the battery or provide other status indicators. A battery system management circuit 2328 is coupled between the battery 2322 and a battery charging circuit 2330, where the battery system management circuit controls the application of a charging current to the battery. The battery may be rechargeable using a USB cable for example. A fuse 2332 is also provide to prevent any improper condition associated with the device.

[0112] The elements of Fig. 23 may be implemented in the fluid monitoring device of Figs. 16 and 17 for example or other suitable devices. According to some implementations, some of the elements of the circuit 2301 of Fig. 23 may be implemented in the control circuit 1628 or user interface 1712.

[0113] Turning now to Fig. 24, a flowchart shows a method of implementing the device of Fig. 17. A primary path adapted to receive a fluid and extending from a first end to a second end is provided at a block 2402. A shunt path extending from a first opening in the primary path and allowing fluid to flow to a second opening in the primary path is provided at a block 2402. A fluid monitoring circuit is coupled to the shunt path at a block 2402. The fluid is monitored, using the fluid monitoring circuit, to determine a characteristic of the fluid at a block 2402.

[0114] According to other aspects, the coupling of the fluid monitoring circuit to the shunt path may comprise configuring a capacitor to monitor the flow of urine through a catheter attached to the portable urinary monitoring device, and the capacitor may comprise a pair of capacitor plates positioned on the shunt path. The coupling of the fluid monitoring circuit to the shunt path may comprise configuring electrodes to monitor the flow of urine, wherein the electrodes are adapted to detect a conductivity of the urine. According to further aspects, the shunt path may comprise a test portion comprising a capacitor having a pair ofAttorney Docket No. 3400-0338.01 (816PCT) capacitor plates positioned on the test portion and electrodes positioned within the test portion to detect a conductivity of the urine. A funnel device adapted to be couped to a proximal end of the portable urinary monitoring device may be used, and in addition to a catheter to be attached to the funnel device.

[0115] It will be understood that the embodiments and examples described above are illustrative of some of the applications of the principles of the present subject matter. Numerous modifications may be made by those skilled in the art without departing from the spirit and scope of the claimed subject matter, including those combinations of features that are individually disclosed or claimed herein. For these reasons, the scope hereof is not limited to the above description but is as set forth in the following claims, and it is understood that claims may be directed to the features hereof, including as combinations of features that are individually disclosed or claimed herein.

Claims

Attorney Docket No. 3400-0338.01 (816PCT)What is Claimed:1 . A portable urinary catheter monitoring device comprising: a barrel at least partially circumferentially enclosed and including a first end and a second end; a channel defined by the at least partially circumferentially enclosed barrel, the channel extending between the first end and the second end and configured to receive a portion of an intermittent urinary catheter; a flow meter assembly located in the channel; and a controller associated with the flow meter assembly, wherein the controller is configured to receive data from the flow meter assembly and to transmit the data to a computing device.

2. The device of claim 1 , further including a base, wherein the barrel is associated with the base.

3. The device of any one of claims 1 -2, wherein the barrel is fully circumferentially enclosed.

4. The device of any one of claims 1 -3, wherein the flow meter assembly is an electromagnetic sensor.

5. The device of claim 4, wherein the electromagnetic sensor includes a hole defining a flow path and wherein the electromagnetic sensor is configured to detect urine flow within the hole.

6. The device of claim 5, wherein the electromagnetic sensor includes a pair of windings and electrodes placed perpendicular to each other.

7. The device of claim 3, wherein the flow meter assembly is a Hall-effect flowmeter.

8. The device of claim 7, wherein the Hall-effect flowmeter includes a sensor and an impeller including a magnet.

9. The device of claim 8, wherein the impeller is partially located in the channel.

10. The device of claim 7, wherein the Hall-effect flowmeter includes a sensor and a turbine including a magnet, the turbine being located within the channel.1 1 . The device of any one of claims 1 -3, wherein the flow meter assembly includes a thermal sensor.Attorney Docket No. 3400-0338.01 (816PCT)12. The device of claim 11 , wherein the thermal sensor includes a first thermocouple / thermistor, a heating element, and a second thermocouple / thermistor.

13. The device of any one of claims 11-12, wherein the thermal sensor is embedded on an inner surface of the barrel.

14. The device of any one of claims 1 -13, comprising a coupling element located at the second end, wherein the coupling element is configured to be coupled to a portion of the intermittent urinary catheter.

15. The device of any one of claims 1 -14, wherein the coupling element includes a clip within the channel configured to receive a portion of the intermittent urinary catheter.

16. The device of any one of claims 1 -14, wherein the intermittent urinary catheter includes a catheter tube and the channel is configured to receive a portion of a catheter tube, and wherein the flow meter assembly is configured to detect flow of urine through the catheter tube.

17. The device of any one of claims 3-15, wherein the channel is configured to directly receive urine from the intermittent urinary catheter and the flow meter assembly is configured to detect urine flowing through the channel.

18. The device of claim 17, wherein the intermittent urinary catheter includes a drainage member that is received within the channel.

19. The device of any one of claims 1 -18, wherein the controller is configured to record one or more of void volume, void rate, void frequency, and void time based on information from the flow meter assembly.

20. The device of any one of claims 1 -19, wherein the barrel includes an attachment member configured to attach the device to a personal mobility device.21 . The device of any one of claims 1 -20, wherein the base includes a power source.

22. A method of monitoring catheterization comprising: attaching an intermittent urinary catheter to a portable urinary catheter monitoring device, wherein the intermittent urinary catheter includes a proximal insertion end, a distal drainage end, and a catheter tube extending between the proximal insertion end and the distal drainage end, and wherein the portable urinary catheter monitoring device comprisesAttorney Docket No. 3400-0338.01 (816PCT) a barrel at least partially circumferentially enclosed and including a first end and a second end; a channel defined by the at least partially circumferentially enclosed barrel, the channel extending between the first end and the second end and configured to receive a portion of the intermittent urinary catheter; a flow meter assembly located in the channel; and a controller associated with the flow meter assembly, wherein the controller is configured to receive data from the flow meter assembly and to transmit the data to a computing device; and transmitting the data to a computing device.

23. The method of claim 22, wherein the catheter monitoring device further includes a base, wherein the barrel is associated with the base.

24. The method of any one of claims 22-23, wherein the barrel is fully circumferentially enclosed.

25. The method of any one of claims 22-24, wherein the flow meter assembly is an electromagnetic sensor.

26. The method of claim 25, wherein the electromagnetic sensor includes a hole defining a flow path and the electromagnetic sensor is configured to detect urine flow within the hole.

27. The method of claim 26, wherein the electromagnetic sensor includes a pair of windings and electrodes placed perpendicular to each other.

28. The method of claim 24, wherein the flow meter assembly is a Hall-effect flowmeter.

29. The method of claim 28, wherein the Hall-effect flowmeter includes a sensor and an impeller including a magnet.

30. The method of claim 29, wherein the impeller is partially located in the channel.31 . The method of claim 28, wherein the Hall-effect flowmeter includes a sensor and a turbine including a magnet, the turbine being located within the channel.

32. The method of any one of claims 22-24, wherein the flow meter assembly includes a thermal sensor.Attorney Docket No. 3400-0338.01 (816PCT)33. The method of claim 32, wherein the thermal sensor includes a first thermocouple / thermistor, a heating element, and a second thermocouple / thermistor.

34. The method of any one of claims 28-33, wherein the thermal sensor is embedded on an inner surface of the barrel.

35. The method of any one of claims 22-34, wherein the portable urinary catheter monitoring device comprises a coupling element located at the second end, wherein the coupling element is configured to be coupled to a portion of the intermittent urinary catheter.

36. The method of any one of claims 22-35, wherein the coupling element includes a clip within the channel configured to receive a portion of the intermittent urinary catheter.

37. The method of any one of claims 22-36, wherein the intermittent urinary catheter includes a catheter tube and the channel is configured to receive a portion of the catheter tube, and wherein the flow meter assembly is configured to detect flow of urine through the catheter tube.

38. The method of any one of claims 24-36, wherein the channel is configured to directly receive urine from the intermittent urinary catheter and the flow meter assembly is configured to detect urine flowing through the channel.

39. The method of claim 38, wherein the intermittent urinary catheter includes a drainage member that is received within the channel.

40. The method of any one of claims 22-38, wherein the controller is configured to record one or more of void volume, void rate, void frequency, and void time based on information from the flow meter assembly.41 . The method of any one of claims 22-40, wherein the base includes a power source.

42. The method of any one of claims 22-41 , wherein the barrel includes an attachment member configured to attach the device to a personal mobility device.

43. The method of any one of claims 22-42, comprising inserting the intermittent urinary catheter into a patient by handling the base after attaching the intermittent urinary catheter to the base.Attorney Docket No. 3400-0338.01 (816PCT)44. The method of any one of claims 22-43, comprising directing the distal drainage end of the catheter towards a receptacle and draining urine from the intermittent urinary catheter into the receptacle.

45. A system for monitoring intermittent urinary catheterization comprising: an intermittent urinary catheter including a proximal insertion end, a distal drainage end, and a catheter tube extending between the proximal insertion end and the distal drainage end; a portable urinary catheter monitoring device comprising a base; a barrel connected to the base, wherein the barrel is at least partially circumferentially enclosed and includes a first end and a second end, a channel defined by the at least partially enclosed barrel, the channel extending between the first end and the second end and configured to receive a portion of the intermittent urinary catheter; a flow meter assembly located in the channel; and a controller associated with the flow meter assembly, wherein the controller is configured to receive data from the flow meter assembly and to transmit the data to a computing device; and the computing device.

46. The system of claim 45, wherein the barrel is fully circumferentially enclosed.

47. The system of any one of claims 45-46, wherein the flow meter assembly is an electromagnetic sensor.

48. The system of claim 47, wherein the electromagnetic sensor includes a hole defining a flow path and the electromagnetic sensor is configured to detect urine flow within the hole.

49. The system of claim 48, wherein the electromagnetic sensor includes a pair of windings and electrodes placed perpendicular to each other.

50. The system of claim 46, wherein the flow meter assembly is a Hall-effect flowmeter.51 . The system of claim 50, wherein the Hall-effect flowmeter includes a sensor and an impeller including a magnet.Attorney Docket No. 3400-0338.01 (816PCT)52. The system of claim 51 , wherein the impeller is partially located within the channel.

53. The system of claim 50, wherein the Hall-effect flowmeter includes a sensor and a turbine including a magnet, the turbine being located within the channel.

54. The system of any one of claims 45-46, wherein the flow meter assembly includes a thermal sensor.

55. The system of claim 54, wherein the thermal sensor includes a first thermocouple, a heating element, and a second thermocouple.

56. The system of any one of claims 54-55, wherein the thermal sensor is embedded on an inner surface of the barrel.

57. The system of any one of claims 45-56, wherein the portable urinary catheter monitoring device comprises a coupling element located at the second end, wherein the coupling element is configured to be coupled to a portion of the intermittent urinary catheter.

58. The system of any one of claims 45-57, wherein the coupling element includes a clip within the channel configured to receive a portion of the intermittent urinary catheter.

59. The system of any one of claims 45-58, wherein the channel is configured to receive at least a portion of the catheter tube and the flow meter assembly is configured to detect flow of urine through the catheter tube.

60. The system of any one of claims 46-58, wherein the channel is configured to directly receive urine from the intermittent urinary catheter and the flow meter assembly is configured to detect urine flowing through the channel.61 . The system of claim 60, wherein the distal drainage end of the catheter includes a drainage member that is received within the channel.

62. The system of any one of claims 45-61 , wherein the controller is configured to record one or more of void volume, void rate, void frequency, and void time based on information from the flow meter assembly.

63. The system of any one of claims 45-62, wherein the base includes a power source.

64. The system of any one of claims 45-63, wherein the barrel includes an attachment member configured to attach the base to a personal mobility device.Attorney Docket No. 3400-0338.01 (816PCT)65. The system of any one of claims 45-64, wherein the computing device is a smartphone, smartwatch, laptop, computer, or other smart device.

66. A portable urinary monitoring device comprising: a primary path adapted to receive a fluid and extending from a first end to a second end; a shunt path extending from a first opening in the primary path and allowing fluid to flow to a second opening in the primary path; and a fluid monitoring circuit associated with the shunt path; wherein the fluid monitoring circuit monitors the fluid to determine a characteristic of the fluid.

67. The portable urinary monitoring device of claim 66 wherein the fluid monitoring circuit comprises a capacitor configured to monitor the flow of urine through a catheter attached to the portable urinary monitoring device.

68. The portable urinary monitoring device of claim 67 wherein the capacitor comprises a pair of capacitor plates positioned on the shunt path.

69. The portable urinary monitoring device of any one of claims 66-68 further comprising electrodes positioned to monitor the flow of urine, wherein the electrodes are adapted to detect a conductivity of the urine.

70. The portable urinary monitoring device of any one of claims 66-69 wherein the shunt path comprises a test portion comprising a capacitor having a pair of capacitor plates positioned on the test portion and electrodes positioned within the test portion to detect a conductivity of the urine.71 . The portable urinary monitoring device of any one of claims 66-70 further comprising a funnel device adapted to be couped to a proximal end of the portable urinary monitoring device.

72. The portable urinary monitoring device of any one of claims 66-71 further comprising a catheter adapted to be attached to the funnel device.

73. A portable urinary monitoring device comprising: a primary path adapted to receive a fluid and extending from a first end to a second end; a shunt path extending from a first opening in the primary path and allowing fluid to flow to a second opening in the primary path; and a capacitor associated with the shunt path;Attorney Docket No. 3400-0338.01 (816PCT) wherein the capacitor monitors the fluid to determine a characteristic of the fluid.

74. The portable urinary monitoring device of claim 73 wherein the capacitor comprises a pair of capacitor plates positioned on the shunt path.

75. The portable urinary monitoring device of any one of claims 73-74 further comprising electrodes positioned to monitor the flow of urine, wherein the electrodes are adapted to detect a conductivity of the urine.

76. The portable urinary monitoring device of any one of claims 73-75 wherein the shunt path comprises a test portion comprising a capacitor having a pair of capacitor plates positioned on the test portion and electrodes positioned within the test portion to detect a conductivity of the urine.

77. The portable urinary monitoring device of any one of claims 73-76 further comprising a funnel device adapted to be couped to a proximal end of the portable urinary monitoring device.

78. The portable urinary monitoring device of any one of claims 73-77 further comprising a catheter adapted to be attached to the funnel device.

79. A method of implementing a portable urinary monitoring device, the method comprising: providing a primary path adapted to receive a fluid and extending from a first end to a second end; providing a shunt path extending from a first opening in the primary path and allowing fluid to flow to a second opening in the primary path; and coupling a fluid monitoring circuit to the shunt path; monitoring, using the fluid monitoring circuit, the fluid to determine a characteristic of the fluid.

80. The method of claim 79 wherein coupling the fluid monitoring circuit to the shunt path comprises configuring a capacitor to monitor the flow of urine through a catheter attached to the portable urinary monitoring device.81 . The method of claim 80 wherein the capacitor comprises a pair of capacitor plates positioned on the shunt path.

82. The method of any one of claims 79-81 wherein coupling the fluid monitoring circuit to the shunt path comprises configuring electrodes to monitorAttorney Docket No. 3400-0338.01 (816PCT) the flow of urine, wherein the electrodes are adapted to detect a conductivity of the urine.

83. The method of any one of claims 79-82 wherein the shunt path comprises a test portion comprising a capacitor having a pair of capacitor plates positioned on the test portion and electrodes positioned within the test portion to detect a conductivity of the urine.

84. The method of any one of claims 79-83 further comprising enabling a funnel device to be couped to a proximal end of the portable urinary monitoring device.

85. The method of claim 84 further comprising enabling a catheter to be attached to the funnel device.

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