Catheter assembly with reusable sensor

Abstract

A portable catheterization monitoring device. More particularly, a portable catheterization associated with a computing device. Even more particularly, a catheterization monitoring device associated with a health and / or catheterization monitoring system.

Description

CATHETER ASSEMBLY WITH REUSABLE SENSORThe present application claims the benefit of and priority to U.S. Provisional Application 63 / 654,414, filed May 31 , 2024, which is hereby incorporated herein by reference.FIELD OF THE INVENTION

[0001] This disclosure generally relates to devices, systems, and methods for monitoring catheterization. In particular, the present disclosure relates to a portable catheterization monitoring device and 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 that 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). The need to manage selfcatheterization 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’scatheterization. A user may share this information with a clinician to keep track of the user’s catheterization. Yet, users may forget to input data regarding catheterizations, forget to carry the device when travelling, and forget to share information with the clinician 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.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 catheterization monitoring device is provided. The urinary catheterization monitoring device includes an intermittent urinary catheter. The urinary catheter includes a catheter proximal insertion end, a catheter distal end, and a lumen extending from the catheter proximal insertion end to the catheter distal end. The urinary catheterization monitoring device also includes a refurbishable sensor unit configured to record catheterization data. The refurbishable sensor unit includes a sensor unit proximal end and a sensor unit distal end and a sensor lumen in fluid communication with the urinary catheter. The sensor lumen extends from the sensor unit proximal end to the sensor unitdistal end. The urinary catheterization monitoring device also includes a case configured to house the refurbishable sensor unit and at least a portion of the urinary catheter. Additionally, the urinary catheterization monitoring device includes a controller associated with the refurbishable sensor unit. The controller is configured to receive catheterization data from the refurbishable sensor unit and to transmit the catheterization data to a computing device.

[0008] In another aspect, a urinary catheterization monitoring system is provided. The system includes a plurality of intermittent urinary catheterization monitoring devices. The urinary catheterization monitoring device includes an intermittent urinary catheter. The urinary catheter includes a catheter proximal insertion end, a catheter distal end, and a lumen extending from the catheter proximal insertion end to the catheter distal end. The urinary catheterization monitoring device also includes a refurbishable sensor unit configured to record catheterization data. The refurbishable sensor unit includes a sensor unit proximal end and a sensor unit distal end and a sensor lumen in fluid communication with the urinary catheter. The sensor lumen extends from the sensor unit proximal end to the sensor unit distal end. The urinary catheterization monitoring device, optionally, also includes a case configured to house the refurbishable sensor unit and at least a portion of the urinary catheter. Additionally, the urinary catheterization monitoring device includes a controller associated with the refurbishable sensor unit. The controller is configured to receive catheterization data from the refurbishable sensor unit and to transmit the catheterization data to a computing device.

[0009] In another aspect, a catheterization monitoring system is provided. Thesystem includes a computing device and a portable intermittent urinary catheter monitoring device. The urinary catheterization monitoring device includes an intermittent urinary catheter. The urinary catheter includes a catheter proximal insertion end, a catheter distal end, and a lumen extending from the catheter proximal insertion end to the catheter distal end. The urinary catheterization monitoring device also includes a refurbishable sensor unit configured to record catheterization data. The refurbishable sensor unit includes a sensor unit proximal end and a sensor unit distal end and a sensor lumen in fluid communication with the urinary catheter. The sensor lumen extends from the sensor unit proximal end to the sensor unit distal end. The urinary catheterization monitoring device also includes a case configured to house the refurbishable sensor unit and at least a portion of the urinary catheter. Additionally, the urinary catheterization monitoring device includes a controller associated with the refurbishable sensor unit. The controller is configured to receive catheterization data from the refurbishable sensor unit and to transmit the catheterization data to a computing device.

[0010] In yet another aspect, a method of monitoring intermittent catheterization is provided. The method includes obtaining a portable intermittent urinary catheterization monitoring device. The portable urinary catheterization monitoring device includes an intermittent urinary catheter, a refurbishable sensor unit, and a case. The method also includes catheterizing using the portable urinary catheterization monitoring device and sending the portable urinary catheterization monitoring device for refurbishing.BRIEF DESCRIPTION OF DRAWINGS

[0011] FIG. 1 is a rear perspective view of an example of a catheterizationmonitoring device of the present disclosure in a disassembled configuration.

[0012] FIG. 2 is a rear perspective view of an example of a catheterization monitoring device with a lid in an open configuration.

[0013] FIG. 3 is a front perspective view of an example of a sensor unit of the catheterization monitoring device in a disassembled configuration.

[0014] FIG. 4 is a rear perspective view of an example of a case of a catheterization monitoring device.

[0015] FIG. 5 is a front view of the example of the case of FIG. 4.

[0016] FIG. 6 is a front perspective view of an example of a catheterization monitoring device with a first cut out portion directly showing the device components in a stored configuration within the case and a second cut out portion cutting through a front panel and showing the device components underneath a back panel.

[0017] FIG. 7 is a bottom plan view of an example of a catheterization monitoring device.

[0018] FIG. 8A is a front view of a catheterization monitoring device with an exemplary embodiment of the front panel in an open configuration and the urinary catheter in a stored configuration.

[0019] FIG. 8B is a front view of the catheterization monitoring device of FIG. 8A with the urinary catheter in a deployed configuration.

[0020] FIG. 9 is a front perspective view of a package containing multiple catheterization monitoring devices of the present disclosure and a catheterization monitoring device removed from the package.

[0021] FIG. 10 is a plan view of a catheterization monitoring system including the catheterization monitoring device of the present disclosure.DETAILED DESCRIPTION

[0022] 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.

[0023] Turning to FIG. 1 , the figure illustrates an example of a catheterization monitoring device 10 including a urinary catheter 12 (such as an intermittent urinary catheter), a refurbishable sensor unit 14, and a case 16. FIG. 2 illustrates the monitoring device 10 in an assembled and open configuration. The catheterization monitoring device 10 is a portable device that is configured to monitor catheterization. The catheterization monitoring device 10 may be associated or operatively in communication with a catheterization monitoring system 90 (shown in FIG. 10), including a computing device 92. The catheterization monitoring device 10 can track a variety of catheterization statistics including, but not limited to, fluid flow, catheterization time, and fluid volume. The catheterization monitoring system 90 may track a variety of catheterization statistics including, but not limited to, fluid flow, catheterization time, fluid volume, urine analysis (sugar, protein, pH, bacteria levels, etc.), and catheterization monitoring device inventory.

[0024] Referring to FIG. 3, additionally, catheterization monitoring device 10 includes a controller 13. In an example, sensor unit 14 of the catheterization monitoring device 10 includes controller 13. Alternatively, controller 13 can be an external controller associated with the sensor unit 14. The controller 13 isconfigured to receive catheterization data collected at the sensor unit 14 and to transmit the catheterization data to a computing device 92. In an example, the controller 13 includes a memory configured to store catheterization data. Additionally, the controller 13 can include a transceiver module configured to receive and send catheterization data via a wireless or wired connection.

[0025] Turning back to FIGS. 1 and 2, as disclosed above, catheterization monitoring device 10 includes a urinary catheter 12. Urinary catheter 12 includes a catheter tube 18 having a catheter proximal insertion end 20 and a catheter distal end 22. A lumen (not shown) extends from the catheter proximal insertion end 20 to the catheter distal end 22. The catheter proximal insertion end 20 includes one or more openings (not shown) for receiving urine in communication with the lumen. In an example, the one or more openings for receiving urine may be an eyelet. In another example, the one or more openings for receiving urine may be multiple eyelets. The size, shape and location of the one or more openings for receiving urine may vary without departing from the scope of the disclosure.

[0026] The catheter distal end 22 includes a drainage opening for draining urine from the lumen. In an example, the catheter distal end 22 includes a connector 24. The connector 24 is configured to be connected to the sensor unit 14. Additionally, the connector 24 may be, for example, but not limited to, a drainage member.

[0027] In some examples, the catheter tube 18 may include a hydrophilic polymer coating on an outer surface of the catheter tube 18. The hydrophilic polymer coating is configured to absorb a hydrating medium to lubricate the catheter to aid in insertion into a urethra.

[0028] Additionally, the catheterization monitoring device 10, as shown in FIG.1 , includes a refurbishable sensor unit 14 configured to sense and record catheterization data. In some embodiments, the refurbishable sensor unit 14 is configured to be returned to a service center (e.g., the catheterization monitoring device manufacturer) for refurbishment. Refurbishment may include cleaning, sterilizing, repairing, and / or any other suitable procedure to prepare the sensor unit 14 for reuse within a new catheterization monitoring device 10.

[0029] In an example, the refurbishable sensor unit 14 includes a sensor housing 26 and a sensor 28. In particular, the sensor housing 26 defines a sensor chamber configured to contain the sensor 28. As shown in FIG. 3, the housing is openable to allow the service center (the catheterization monitoring device manufacturer) to access the sensor 28 for refurbishment. For example, as illustrated in FIG. 3, the sensor housing 26 can be a two-piece housing including a first piece 27a and a second piece 27b. The first piece 27a and second piece 27b of the sensor housing 26 may be attached to one another via a snap-fit or other suitable attachment means. Without departing from the scope of the disclosure, the housing may be differently configured. For instance, the housing may include a base unit with an attachable or openable lid.

[0030] Additionally, as shown in FIG. 1 , the sensor unit 14 includes a sensor unit proximal end 30 with a proximal end aperture (not shown) and a sensor unit distal end 34 with a distal end aperture 36. In an example, when the sensor housing 26 is a two-piece housing, as illustrated in FIG. 3, each of the first piece 27a and second piece 27b can include housing notches 29 at both of the sensor unit proximal end 30 and at the sensor unit distal end 34. When the two-piece housing 26 is assembled, the housing notches 29 define the proximal endaperture and the distal end aperture 36. Alternatively, the proximal end aperture and distal end aperture 36 can be formed in the sensor unit proximal end 30 and sensor unit distal end 34, respectively, by any suitable means.

[0031] As disclosed herein, the urinary catheter 12 is connectable to the sensor unit 14. In particular, the connector 24 of urinary catheter 12 can be connected to the proximal end aperture at the sensor unit proximal end 30. The connector 24 can be connected to the proximal end aperture via a snap-fit, a twist-lock connection, a mechanical fit, a friction fit, or any other suitable fluid-tight connection. In an example, proximal end aperture can include a port 32 and connector 24 can be connected to the port 32.

[0032] By connecting the connector 24 to the proximal end aperture, urinary catheter 12 is placed in fluid communication with the sensor unit 14. Accordingly, as urine is drained from a user’s bladder using the urinary catheter 12, the urine travels through the catheter tube 18 and enters the sensor unit 14. As the urine flows through the sensor unit 14, the sensor 28 can record catheterization data. Urine can exit the sensor unit 14 through the sensor unit distal end aperture 36. After use, the urinary catheter 12 can be detached from the sensor unit 14 and disposed.

[0033] As disclosed herein, the sensor 28 is configured to sense and record catheterization data and can be any suitable sensor to record catheterization data. For instance, the sensor 28 is configured to track a variety of statistics, including, but not limited to fluid flow, catheterization time, fluid volume, urine analysis (sugar, protein, pH, bacteria levels, etc.), and number of catheterizations.

[0034] The sensor 28 can include a sensor lumen 38, as shown in FIG. 3. The sensor lumen 38 can extend from the sensor unit proximal end 30 to the sensorunit distal end 34. Accordingly, when located within the sensor housing 26, sensor lumen 38 is in fluid communication with the proximal end aperture and the distal end aperture 36. In an example, the sensor 28 is a differential-pressure sensor. As urine flows from the urinary catheter 12 and through the sensor lumen 38 of the sensor unit 14, the sensor 28 will record catheterization data. For instance, if the sensor 28 is a pressure-differential sensor, based on the pressure difference at two locations within the sensor lumen 38, the controller 13 associated with the sensor unit 14 can determine flow rate, catheterization time, and volume of fluid drained during catheterization.

[0035] Furthermore, the sensor unit 14 can include a variety of other components without departing from the scope of the disclosure. For instance, sensor unit 14 can include a distal aperture leak-guard 25 (FIG. 2) such as a gasket or an O-ring. The distal aperture leak-guard 25 can be engaged with the case 16 to keep fluid from leaking from the sensor unit 14 when the catheterization monitoring device 10 is in a stored configuration. Additionally, sensor unit 14 can include a power source 33 (FIG. 3). For example, the power source 33 can be a single-use or rechargeable battery located within the sensor housing. The sensor unit 14 can also include a speaker or alert module configured to alert the user. For example, a controller 13 associated with the sensor can operate the device 10 to produce a sound or vibration to alert the user if a predetermined threshold for a particular catheterization property is reached.

[0036] Turning to FIG. 4, the figure illustrates a case 16 configured to hold the urinary catheter 12 and the sensor unit 14. The case includes a base 40 with a base proximal end 41 and a base distal end 43. The base 40 also includes an openable lid 42. The base 40 and lid 42 define a chamber 51 configured to hold atleast a portion of the urinary catheter 12 and the sensor unit 14.

[0037] In particular, the base 40 includes a back panel 44 and walls extending from the perimeter of the back panel 44. In particular, the base 40 includes a proximal wall 46 at the base proximal end 41 , a distal wall 48 at the base distal end 43, a first side wall 50, and a second side wall 52. The first and second side walls 50 and 52 are parallel to one another and extend between the proximal wall 46 and the distal wall 48. In an example, as shown in FIG. 4, the base proximal end 41 can include a tiered proximal wall 46, such that a first proximal wall portion 47a and a second proximal wall portion 47b extend along different, but parallel planes. As illustrated in FIG. 4, the length between the first proximal wall portion 47a and the distal wall 48 is shorter than that of the second proximal wall portion 47b and the distal wall 48.

[0038] Additionally, proximal wall 46 includes a case aperture 54. Case aperture 54 is configured to receive at least a portion of urinary catheter 12. For example, when placing the urinary catheter 12 into the case 16, the catheter distal end 22 can be guided through the case aperture 54 into the case 16 or catheter proximal insertion end 20 can be fed from the inside of the case 16, through the case aperture 54. As shown in FIGS. 1 and 4, case aperture 54 can be located on the first proximal wall portion 47a. Alternatively, the case aperture 54 can be located on any of the walls 46, 48, 50, and 52, including second proximal wall portion 47b, without departing from the scope of the disclosure.

[0039] Case aperture 54 can be configured to retain a protective cap 55 located on the catheter proximal insertion end 20. For example, the protective cap 55 can be placed on the catheter proximal insertion end 20 before or after guiding the catheter tube 18 through the case aperture 54. After covering the catheterproximal insertion end 20 with the cap 55, the cap 55 can be attached to the case aperture 54 via a snap-fit, friction-fit, screw-fit, or any other suitable attachment means.

[0040] Base 40 can also include a partition wall 53 extending between the first and second side walls 50 and 52, dividing the chamber 51 into a first compartment 56 and a second compartment 58. The partition wall 53 can include a partition wall notch 57 configured to receive sensor unit proximal end aperture. For example, when sensor unit proximal end aperture includes a port 32, partition wall notch 57 can receive the port 32 to allow the sensor unit 14 and attached urinary catheter 12 to fit within the case 16 and to hold the sensor unit 14 in place.

[0041] The first compartment 56 is located near the base proximal end 41 and can be sized to contain at least a portion of the urinary catheter 12, including the catheter tube 18. Depending on the length of the catheter tube 18, the catheter tube 18 can be coiled to fit within the first compartment 56, as shown in FIG. 2.

[0042] The second compartment 58 is located near the base distal end 43 and can be sized to contain the sensor unit 14. In an example, the sensor unit 14 and second compartment 58 have corresponding shapes, such that when the sensor unit 14 is placed within the second compartment 58, the sensor unit 14 does not move within the second compartment 58. Additionally, the distal wall 48 of the case 16 includes a distal wall notch 60 configured to align with the sensor unit distal end aperture 36. In the instance the sensor unit 14 includes a distal aperture leak-guard 25, the distal wall notch 60 is also configured to receive the distal aperture leak-guard 25, such that when the sensor unit 14 is placed into the case 16, the distal aperture leak-guard 25 is flush with the distal wall 48 or extends slightly beyond the distal wall 48. By being flush with or slightly extending beyondthe distal wall 48, a front panel 64 of the case 16 can engage with the leak-guard25 to create a liquid-tight seal, preventing fluid from leaking from the sensor unit14 when the catheterization monitoring device 10 is in a stored configuration.

[0043] As disclosed herein, case 16 includes a lid 42. The lid 42 is shaped to correspond with the shape of the base 40 and is openable to allow access into the case 16. The lid 42 can be placed and held in a closed configuration via a snap-fit, friction-fit, or any other suitable means, including, but not limited to a latch. By allowing access to the case 16, a catheterization monitoring device servicer can access the chamber 51 to assemble the catheterization monitoring device 10 or to remove the sensor unit 14 for refurbishment. In an example, the lid 42 can be hingedly attached to either first side wall 50 or second side wall 52 of base 40. In particular, as shown in FIGS. 1 -2 and 4, lid 42 is hingedly attached to the first side wall 50 at an opposed end of the wall 50 from the back panel 44. Alternatively, the lid 42 can be a removeable lid that can be attached to the base 40 in any suitable manner.

[0044] The lid 42 can include retaining members 62. The retaining members 62 are located on a lid inner surface 61 such that when the lid is in a closed position, the retaining member 62 align with the partition wall notch 57 and the distal wall notch 60. Together with the partition wall notch 57 and the distal wall notch 60, the retaining members 62 secure the device components (e.g., the sensor unit 14 and urinary catheter 12) in place within the case 16.

[0045] Additionally, case 16 can include a front panel 64 attached to a side wall 50 or 52 (whichever is opposite the side wall to which the lid 42 is attached). In an example, as shown in FIGS. 1 -2 and 4, the front panel 64 is attached to second side wall 52 at or near the back panel 44. The front panel 64 is hingedlyattached to the case 16 to allow the front panel 64 to be placed in an open configuration and a closed configuration.

[0046] As shown in FIG. 5, front panel 64 can include a generally rectangular shape. For instance, front panel 64 includes a top edge 66, a bottom edge 68, a first side edge 70, and a second side edge 72. As illustrated in FIG. 5, the top edge 66 is located at the base proximal end 41 , the bottom edge 68 is located at the base distal end 43, and the first side edge 70 is attached to the base 40. The front panel 64 also includes a top surface 71 and an opposed bottom surface 74 (shown in FIGS. 8A and 8B) configured to face the back panel 44 when the front panel 64 is placed in a closed configuration. Because the front panel 64 can have a generally rectangular shape, when the front panel 64 is placed in the closed configuration, the catheterization monitoring device 10 includes a generally rectangular profile resembling a wallet. Accordingly, the generally rectangular profile of the device 10 allows a user to conveniently carry the device in a pocket. Additionally, because of the wallet-like profile, the device 10 looks like a wallet if the device 10 is visible when placed in a user’s pocket, providing the user confidence to carry the device 10 on their person.

[0047] Furthermore, the front panel 64 can be used to display instructions to the user. For example, as shown in FIGS. 8A and 8B, instructions on how to use the device 10 and / or other information can be provided on the front panel bottom surface 74 and / or on the back panel 44. The instructions / information can include how to use the device 10, how to return the device 10 for refurbishment, and other information regarding the device 10 and its method of use. The instructions / information can be printed onto the device 10 or can be applied by any other suitable means, for instance, but not limited to, by writing, etching, or byadhering a label / sticker including the instructions / information. As shown in FIGS. 8A and 8B, the instructions / information are visible to a user when the front panel 64 is placed in an open configuration.

[0048] The front panel 64 can also include flaps extending perpendicularly from the edges 66, 68, 70, and / or 72. In particular, the front panel 64 can include a bottom flap 76 and a side flap 78, as shown in FIG 2. The bottom flap 76 extends perpendicularly from the front panel bottom edge 68 and is parallel with the distal wall 48 of the base 40 when the front panel 64 is placed in a closed configuration. Additionally, when the front panel 64 is placed in a closed configuration, the bottom flap 76 can engage with a distal aperture leak-guard 25 (if present) to create a liquid-tight seal at the base distal end 43 of the case 16. Accordingly, the bottom flap 76 and distal aperture leak-guard 25 prevent fluid from leaking from the sensor unit 14 when the front panel 64 is placed in a closed configuration. Furthermore, bottom flap 76 may close and / or protect aperture 36 of sensing unit 14 during distribution and prior to use. In other embodiments, other removable sealing / closing members may be used in addition to or in alternative to bottom flap 76 to cover, close and / or seal aperture 36. These removable members may include, for example, a foil or plastic peelable cover or tab, or a removable plug.

[0049] The side flap 78 can extend perpendicularly from the side edge 72 and is parallel with the first side wall 50 of the base 40 when the front panel 64 is placed in a closed configuration. As shown in FIG. 2, side flap 78 extends along a portion of the second side edge 72. In an example, the side flap 78 extends along the second side edge 72 from the bottom edge 68 to a location aligning with the first proximal wall portion 47a of the base 40. By only extending the side flap 78partially along the second side edge 72, when the front panel 64 is in a closed configuration, a user can easily grip or slip a finger under the front panel 64 near the first proximal wall portion 47a to place the front panel 64 in an open configuration.

[0050] To assemble the catheterization monitoring device 10, the lid 42 can be placed in an open configuration, revealing the chamber 51 of the case 16. The sensor unit 14 and urinary catheter 12 can then be placed within the chamber 51 of the case 16. In an example, the sensor unit 14 can be placed within second compartment 58 such that the distal end aperture 36 is at the base distal end 43 and the proximal aperture is at the partition wall 53. After inserting the sensor unit 14 into the second compartment 58, the catheter distal end 22 can be guided through the case aperture 54 and the catheter tube 18 can be pulled or pushed into the first compartment 56 until the catheter proximal insertion end 20 remains outside of the case 16. The catheter distal end 22 is then attached to the sensor unit 14. In particular, connector 24 of the urinary catheter 12 is attached to the sensor unit proximal aperture or port 32. Alternatively, after inserting the sensor unit 14 into the second compartment 58, the catheter distal end 22 can be attached to the sensor unit 14 and the catheter tube 18 can be placed into the first compartment 56. The catheter proximal insertion end 20 can then be guided through case aperture 54. A protective cap 55 can be placed over the proximal insertion end 20 of the urinary catheter 12. For instance, the cap 55 can be placed over the catheter proximal insertion end 20 before inserting the urinary catheter into the case if the catheter distal end 22 is guided through the case aperture 54.If the catheter distal end 22 is connected to the sensor unit 14 first and the catheter proximal insertion end 20 is guided through the case aperture 54, the cap55 can be placed over the catheter proximal insertion end 20 after guiding it through the case aperture 54.

[0051] Alternatively, the urinary catheter 12 can be attached to the sensor unit 14 before placing the components into the chamber 51 . For example, after attaching the connector 24 to the sensor unit proximal aperture or port 32, the sensor unit 14 can be placed into the second compartment 58 and the urinary catheter 12 can be placed into the first compartment 56. The proximal insertion end 20 of the urinary catheter 12 can then be guided through the case aperture 54 and a cap 55 can be placed over the case aperture 54.

[0052] After arranging the connected sensor unit 14 and urinary catheter 12 within the case 16, the lid 42 can be placed in a closed configuration. If present, the retaining members 62, together with the partition wall notch 57 and distal wall notch 60, secure the sensor unit 14 and urinary catheter 12 within the case 16. Additionally, the front panel 64 is placed in a closed configuration.

[0053] FIGS. 6 and 7 show examples of the catheterization monitoring device 10 in a stored configuration. In the stored configuration, the urinary catheter 12 and sensor unit 14 are located within the case 16 and the lid 42 and front panel 64 are in their closed configurations. For illustrative purposes only, FIG. 6 shows an example of the catheterization device 10 with two cutaway portions. A first cutaway portion 81 shows portions of the front panel 64 and back panel 44 cut away, directly revealing the contents within the case. In particular, the first cutaway portion 81 shows the inside of the second compartment 58 including the sensor unit 14. A second cutaway portion 82 shows a portion of the front panel 64 cut away. As shown in the second cutaway portion 82, the contents of the catheterization monitoring device 10 are covered by the rear panel 44 and areshown in broken lines for illustrative purposes. The second cutaway portion 82 is located over a portion of the first compartment 56 including the catheter 12 and a portion of the second compartment 58 including the sensor unit 14.

[0054] Turning briefly to FIG. 7, the figure shows the bottom of the catheterization monitoring device 10 in a closed configuration. As shown, when the front panel 64 is in a closed configuration, the bottom flap 76 covers the distal end aperture 36. As described above, the distal end aperture 36 can include a leak-guard 25. When the front panel 64 is in a closed configuration, as shown in FIG. 7, the inside surface of the bottom flap 76 can engage with the leak-guard 25 to create a fluid tight seal, preventing fluid from leaking from the distal end aperture 36.

[0055] The catheterization monitoring device 10 can be provided in a multipack packaging 80 as shown in FIG. 9, such as a carton. In other words, a user can receive multiple catheterization monitoring devices 10 in a single package or carton 80. For example, a package 80 can include a plurality of catheterization monitoring devices 10. In a particular example, a package 80 can include five catheterization monitoring devices 10. As shown in FIG. 9, the devices 10 can be stacked on top of one another and can be arranged within a package 80 such that the base proximal end 41 of the case 16 faces an opening near the bottom of the package. The opening can initially be shut and can be created by a user by tearing a perforated portion of the package 80 or by any other suitable manner. This arrangement of devices 10 within the package 80 allows a user to easily grasp the front panel 64 of the case 16 to pull the device 10 from the package. For instance, a user may grasp the portion of the front panel 64 covering the catheter proximal insertion end 20, adjacent to the first proximal wall portion 47a and thesecond proximal wall portion 47b. After pulling the device 10 out, another device 10 (if present) falls into place near the package opening. The package 80 can also include a return bag(s) (not shown). A user can place used catheterization monitoring devices 10 into the return bag(s) and send the used devices 10 within the return bag to a service center for refurbishment.

[0056] To use catheterization monitoring device 10, after removing the device10 from the package 80, a user places the front panel 64 in the open configuration, revealing the cap 55 covering the catheter proximal insertion end 20 and uncovering the distal end aperture 36 of the sensor unit 14. Additionally, by placing the front panel 64 in the open configuration, any instructions / information present on the front panel 64 and / or back panel 44 is revealed. The user can then remove the cap 55, pull the urinary catheter 12 through the case aperture 54, and catheterize. In an example, to prevent the user from needing to handle the case 16 and urinary catheter 12 at the same time, the user can place the open front panel 64 under their leg and then catheterize.

[0057] After insertion of the proximal insertion end 20 of the urinary catheter tube 18 into a user’s bladder, the user can point the base distal end 43 including the sensor unit distal end aperture 36 towards a suitable drainage receptacle such as a toilet. Alternatively, the distal end aperture 36 can be attached to a drainage container (not shown), which can be disposed of after catheterization. During catheterization, urine flows from the catheter proximal insertion end 20, through the catheter tube 18, and into the sensor unit 14. The sensor unit 14 records catheterization information and can transmit the information to a computing device 92 as described herein.

[0058] After catheterization, the user can remove the catheter tube 18 fromtheir bladder and replace the urinary catheter 12 back into the case 16. The cap 55 can be replaced over the catheter proximal insertion end 20 and case aperture 54 to prevent fluid from leaking through the case aperture 54. Additionally, the front panel 64 is placed in a closed configuration to place bottom flap 76 over the distal end aperture 36 of the sensor unit 14, preventing fluid from leaking through the distal end aperture 36.

[0059] The used catheterization monitoring devices 10 can be returned to a service center for refurbishment. For example, the used devices 10 can be placed into a provided return bag to be shipped to a service center. At the service center, the lid 42 is opened and the urinary catheter 12 and sensor unit 14 are disconnected. The urinary catheter 12 is removed from case 16 and can be disposed. In an alternative, the user may disconnect the catheter 12 after use, properly dispose of it, and return the catheterization device 10 without the catheter 12 to the service center. Sensor unit 14 can be refurbished such that the sensor unit 14 or its separate components (e.g., the sensor housing 26 and the sensor 28) can be reused in a new device 10. The sensor housing 26 and sensor can be made of refurbishable material. Refurbishment can include cleaning, sterilizing, repairing, and / or any other suitable procedure. In an example, the sensor housing 26 can be opened, the sensor 28 can be removed from the sensor housing 26, and the sensor housing 26 and / or sensor 28 can be refurbished to be used in a new catheterization monitoring device 10.

[0060] As disclosed above, the catheterization monitoring device 10 is configured to be associated with a health monitoring system, for example, a catheterization monitoring system 90. FIG. 10 illustrates an exemplary catheterization monitoring system 90, which includes the catheterizationmonitoring device 10. Optionally, the system 90 also includes a computing device 92, such as, but not limited to, a mobile phone, smartphone, tablet, smartwatch, or computer. The catheterization monitoring device 10 can be used to monitor catheterization data, including, but not limited to flow, catheterization time, fluid volume, and / or inventory of catheterization monitoring devices 10. Other catheterization statistics can be monitored without departing from the scope of the disclosure.

[0061] For the purpose of establishing effective communication between the user (or environment) and the catheterization monitoring system 90, the sensor unit 14 of catheterization monitoring device 10 houses a controller 13 and one or more interfaces associated with the controller 13. For example, the controller 13 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. The second interface is configured to provide an output channel establishing communication between the catheterization monitoring device 10 and the external computing device 92, and optionally, directly with a server 98 via a network 96 associated with the catheterization monitoring system 90. The first interface can be coupled to sensor 28, whereas the second interface can be coupled to a transceiver module. In an embodiment, the first and second interfaces may be coupled with controller 13, sensor 28, and / or the transceiver module with circuitry.

[0062] The catheterization monitoring device 10 is configured for wireless communication via primary connection 94 with the computing device 92.Accordingly, the catheterization data recorded by catheterization monitoring device 10 can be transmitted to computing device 92 via primary connection 94.Additionally, the computing device 92 is configured to communicate with a server 98 of the catheterization monitoring system 90 via a network 96, such as a cloudbased network. The computing device 92 may be wirelessly connected to server 98 via computing device connection 100. The server 98 may be operated and / or controlled by the catheter manufacturer and / or a service center.

[0063] In an embodiment, after the sensor 28 records catheterization data, the data may be transmitted to the computing device 92 via primary connection 94. The data may then be accessed by the user on the computing device 92 and / or further transmitted to the server via computing device connection 100 and server connection 103.

[0064] Optionally, after the sensor 28 records catheterization data, the data may be transmitted directly to the server 98 via network 96. For instance, the data may be transmitted to the network 96 via a monitoring device connection 101 and may then be further transmitted to the server 98 via server connection 103.

[0065] The controller 13 further includes the hardware and the firmware that, with the support of program memory and random access memory (RAM), communicates with the sensor 28, 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 92. The memory may store the processed data until successful transmission of the data to the external computing device 92 is confirmed.

[0066] The transceiver module provides communication between the catheterization monitoring device 10 to the external computing device 92 and / or directly with the server 98. 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 catheterization monitoring data from the sensor 28, records the data in the memory for further processing by the controller 13. The controller 13 then may generate a transmission signal embedded with the catheterization data to be transmitted to the external computing device 92.

[0067] Other devices, systems, or means for connection / communication between catheterization monitoring device 10 and other devices or computing devices are also possible. For example, catheterization monitoring device 10 may include a USB port, and / or may be tethered to a device or computer through a wired connection. Alternatively, catheterization 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. Catheterization monitoring device 10 or the computing device 92 with which the catheterization 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.

[0068] The external computing device 92 is equipped with an algorithm such as a mobile app to convert the catheterization monitoring data to meaningful information. For example, the computing device 92 can process the catheterization data, reprocess the data, store the data, retrieve analyzed data,and / or generate reports. In particular, computing device 92 can show catheterization data, such as the flow, catheterization time, the volume of urine discharged, and how many catheterization monitoring devices 10 remain in the user’s inventory. In other examples, catheterization data are transmitted to the server 98. In another example, the transceiver module transmits raw data to a cloud network 96 and / or server 98, or another device.

[0069] Additionally, it should be noted that various methods and operations are described as being executed by the controller 13 in the catheterization 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 catheterization monitoring device 10. Discussions of a particular processing element are meant as illustrative only.

[0070] In an example, the monitoring device 10 / controller 13 is optionally configured to, in accordance with a determination that the primary connection 94 fails to establish, abort transmitting the catheterization data to the computing device 92 and establish a secondary connection to the server 98, wherein the catheterization data is transmitted via the monitoring device connection 101 to network 96, and from network 96 to server 98 via server connection 103.Establishing a secondary connection may comprise activating an idle or inactive secondary connection.

[0071] Catheterization monitoring device 10 or the computing device 92 with which the catheterization monitoring device 10 communicates may optionally be connected to a network (e.g., the internet or a local network) and the data may beshared with and / or processed by other devices or computing devices connected to the network which is accessible at the healthcare provider end.

[0072] The data transmitted to the computing device 92 and / or server 98 may be used to record 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 92 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 104 via a healthcare provider connection 105 to server 98. Additionally, the catheterization data may be accessed from the computing device 92 or server 98 for a healthcare provider 104 to review. In an example, a healthcare provider 104 may be able to access data from either the catheterization monitoring device 10 or the computing device 92 to monitor how frequently a user is catheterizing and / or how much urine is drained during each catheterization. In response, the healthcare provider 104 may be able to send a notification to the user’s computing device 92. Additionally, the portable catheterization monitoring device and / or computing device may be configured to track a user’s catheterization monitoring device inventory. For example, the computing device 92 may include software (or an app may be configured) to receive data regarding a number of devices in a user’s inventory. This may be provided to the computing device 92 based on manual input by a user or the computing device 92 may be configured to track orders of catheterization monitoring devices 10. Based on the number of catheterizations recorded, computing device 92 may track a user’s device inventory by subtracting the number of recorded catheterizations from the device inventory. In an embodiment, when device inventory data reaches a particular pre-determinedthreshold (such as when the inventory is running low), computing device 92 may alert the user. Additionally, in an embodiment, when device inventory reaches a particular threshold or a pre-determined number of catheterizations is recorded, computing device 92 may be configured to automatically order additional catheterization monitoring devices 10 to refill a user’s device inventory. For instance, computing device 92 may send an alert via the network 96 to the catheter manufacturer / provider or healthcare provider 104. By tracking catheterizations, volume of urine drained during catheterization, and device inventory with system 90, a catheterization routine and urinary tract health can be more easily maintained and managed.

[0073] 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

What is Claimed:1 . A portable urinary catheterization monitoring device comprising: a urinary catheter, wherein the urinary catheter comprises a catheter proximal insertion end, a catheter distal end, and a lumen extending from the catheter proximal insertion end to the catheter distal end; a refurbishable sensor unit configured to record catheterization data, the refurbishable sensor unit including a sensor unit proximal end and a sensor unit distal end and a sensor lumen in fluid communication with the urinary catheter, the sensor lumen extending from the sensor unit proximal end to the sensor unit distal end; a case configured to house the refurbishable sensor unit and at least a portion of the urinary catheter; and a controller associated with the refurbishable sensor unit, wherein the controller is configured to receive catheterization data from the refurbishable sensor unit and to transmit the catheterization data to a computing device.

2. The device of claim 1 , wherein the refurbishable sensor unit comprises a sensor housing and a sensor located within the housing, wherein the sensor is associated with the sensor lumen.

3. The device of claim 2, wherein the housing includes a proximal end aperture at the sensor unit proximal end and a distal end aperture at the sensor unit distal end.

4. The device of claim 3, wherein the proximal end aperture includes a port.

5. The device of any one of claims 2-3, wherein the distal end aperture includes a leak-guard.

6. The device of any one of claims 2-5, wherein the sensor is a differentialpressure sensor.

7. The device of any one of claims 1 -6, wherein the sensor unit includes a power source.

8. The device of any one of claims 1 -7, wherein the catheter distal end includes a connector.

9. The device of any one of claims 1 -8, wherein the catheter distal end is coupled to the sensor unit proximal end.

10. The device of any one of claims 1 -9, wherein the case comprises a base and a lid defining a chamber.1 1 . The device of claim 10, wherein the chamber comprises a partition wall dividing the case into a first compartment configured to contain at least a portion of the urinary catheter and a second compartment configured to contain the sensor unit.

12. The device of any one of claims 1 -11 , wherein the case comprises a case aperture configured to receive the urinary catheter.

13. The device of any one of claims 1 -12, wherein the case includes a notch in in a distal wall of the case.

14. The device of any one of claims 1 -13, wherein the case comprises an openable front panel, wherein the front panel reveals device instructions and / or information when the front panel is in an open configuration.

15. The device of claim 14, wherein the openable front panel includes a flap extending in a plane perpendicular to the plane of the openable front panel, wherein the flap is configured to cover the sensor unit distal end when theopenable front panel is in a closed configuration.

16. The device of any one of claims 1 -15, wherein the urinary catheter includes a cap.

17. The device of any one of claims 1 -16, wherein the urinary catheter is disposable.

18. A urinary catheterization monitoring system, comprising a plurality of devices as recited in claims 1 -17.

19. The system of claim 18, comprising a package that includes the plurality of monitoring devices.

20. A catheterization monitoring system comprising: a computing device; and a portable urinary catheter monitoring device comprising: a urinary catheter, wherein the urinary catheter comprises a catheter proximal insertion end, a catheter distal end, and a lumen extending from the catheter proximal insertion end to the catheter distal end; a refurbishable sensor unit configured to record catheterization data, the refurbishable sensor unit including a sensor unit proximal end and a sensor unit distal end and a sensor lumen in fluid communication with the urinary catheter, the sensor lumen extending from the sensor unit proximal end to the sensor unit distal end; a case configured to house the refurbishable sensor unit and at least a portion of the urinary catheter; and a controller associated with the refurbishable sensor unit, wherein the controller is configured to receive catheterization data from therefurbishable sensor unit and to transmit the catheterization data to a computing device.21 . The system of claim 20, wherein the refurbishable sensor unit comprises a sensor housing and a sensor located within the housing, wherein the sensor is associated with the sensor lumen.

22. The system of claim 21 , wherein the housing includes a proximal aperture at the sensor unit proximal end and a distal aperture at the sensor unit distal end.

23. The system of claim 22, wherein the proximal aperture includes a port.

24. The system of any one of claims 22-23, wherein the distal aperture includes a leak-guard.

25. The system of any one of claims 20-24, wherein the sensor is a differentialpressure sensor.

26. The system of any one of claims 20-25, wherein the sensor unit includes a power source.

27. The system of any one of claims 20-26, wherein the catheter distal end includes a connector.

28. The system of any one of claims 20-27, wherein the catheter distal end is coupled to the sensor unit proximal end.

29. The system of any of claims 20-28, wherein the case comprises a base and a lid defining a chamber.

30. The system of claim 29, wherein the chamber comprises a partition wall dividing the chamber into a first compartment configured to contain at least a portion of the urinary catheter and a second compartment configured to contain the sensor unit.31 . The system of any one of claims 20-30, wherein the case comprises a case aperture configured to receive the urinary catheter.

32. The device of any one of claims 20-31 , wherein the case includes a notch in in a distal wall of the case.

33. The system of any one of claims 20-32, wherein the case comprises an openable front panel, wherein the front panel reveals device instructions and / or information when the front panel is in an open configuration.

34. The system of claim 33, wherein the openable front panel includes a flap extending in a plane perpendicular to the plane of the openable front panel, wherein the flap is configured to cover the sensor unit distal end when the openable front panel is in a closed configuration.

35. The system of any one of claims 20-34, wherein the urinary catheter includes a cap.

36. The system of any one of claims 20-35, wherein the urinary catheter is disposable.

37. The system of any one of claims 20-36, wherein the computing device is a smart device, smart phone, smart watch, tablet, or computer.

38. A method of monitoring catheterization comprising: obtaining a portable urinary catheterization monitoring device, wherein the portable urinary catheterization monitoring device includes a urinary catheter, a refurbishable sensor unit, and a case; catheterizing using said portable urinary catheterization monitoring device; and sending the portable urinary catheterization monitoring device forrefurbishing.

39. The method of claim 38, wherein the portable urinary catheter monitoring device comprises: the urinary catheter, wherein the urinary catheter comprises a catheter proximal insertion end, a catheter distal end, and a lumen extending from the catheter proximal insertion end to the catheter distal end; the refurbishable sensor unit configured to record catheterization data, the refurbishable sensor unit including a sensor unit proximal end and a sensor unit distal end and a sensor lumen in fluid communication with the urinary catheter, the sensor lumen extending from the sensor unit proximal end to the sensor unit distal end; the case configured to house the refurbishable sensor unit and at least a portion of the urinary catheter; and a controller associated with the refurbishable sensor unit, wherein the controller is configured to receive catheterization data from the refurbishable sensor and to transmit the catheterization data to a computing device.

40. The method of claim 39, wherein the refurbishable sensor unit comprises a sensor housing and a sensor located within the housing, wherein the sensor is associated with the sensor lumen.41 . The method of claim 40, wherein the housing includes a proximal aperture at the sensor unit proximal end and a distal aperture at the sensor unit distal end.

42. The method of claim 41 , wherein the proximal aperture includes a port.

43. The method of any one of claims 41-42, wherein the distal aperture includes a leak-guard.

44. The method of any one of claims 39-43, wherein the sensor is a differentialpressure sensor.

45. The method of any one of claims 39-44, wherein the sensor unit includes a power source.

46. The method of any one of claims 39-45, wherein the catheter distal end includes a connector.

47. The method of any one of claims 39-46, wherein the catheter distal end is coupled to the sensor unit proximal end.

48. The method of any one of claim 39-47, wherein the case comprises a base and a lid defining a chamber.

49. The method of claim 48, wherein the chamber comprises a partition wall dividing the chamber into a first compartment configured to contain at least a portion of the urinary catheter and a second compartment configured to contain the sensor unit.

50. The method of any one of claims 39-49, wherein the case comprises a case aperture configured to receive the urinary catheter.51 . The method of any one of claims 39-50, wherein the case includes a notch in a distal wall of the case.

52. The method of any one of claims 39-51 , wherein the case comprises an openable front panel, wherein the front panel reveals device instructions and / or information when the front panel is in an open configuration.

53. The method of claim 52, wherein the openable front panel includes a flap extending in a plane perpendicular to the plane of the openable front panel, wherein the flap is configured to cover the sensor unit distal end when theopenable front panel is in a closed configuration.

54. The method of any one of claims 39-53, wherein the urinary catheter includes a cap.

55. The method of any one of claims 39-54, wherein the computing device is a smart device, smart phone, smart watch, tablet, or computer.

56. The method of any one of claims 38-55, wherein the step of obtaining the portable urinary catheterization monitoring device comprises obtaining a package including multiple of the portable urinary catheterization monitoring devices.

57. The method of any one of claims 38-56, further comprising disposing the urinary catheter after use.

58. The method of any one of claims 38-57, further comprising refurbishing the sensor unit.

59. The method of claim 58, wherein refurbishing the sensor unit includes cleaning, sterilizing, and / or repairing the sensor unit.

60. The method of any of claims 58-59, comprising using a refurbished sensor unit in a new urinary catheterization monitoring device.61 . The method of any one of claims 58-60, comprising attaching a new urinary catheter to the refurbished urinary catheterization monitoring device.

62. The method of any one of claims 39-61 , comprising accessing catheterization data on a computing device.

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