WO2025250985A1

WO2025250985A1 - Catheterization monitor

Info

Publication number: WO2025250985A1
Application number: PCT/US2025/031722
Authority: WO
Inventors: Michael G. Murray; Alexandra MOREHEAD; Derek VALLENCE; Patrick Enda O'DOWD
Original assignee: Hollister Inc
Current assignee: Hollister Inc
Priority date: 2024-05-31
Filing date: 2025-05-30
Publication date: 2025-12-04
Anticipated expiration: 2026-11-30

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

CATHETERIZATION MONITOR

The present application claims the benefit of and priority to U.S. Provisional Application 63/654,327, 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 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 useful 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). The need to manage selfcatheterization and such a disconnect can overwhelm the catheter user.

[0004] Proper catheterization can minimize the risk of 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 keep track of the user’s catheterization. Yet, users may forget to input data regarding catheterizations, forget to carry the product 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 catheterization monitoring device is provided. The portable catheterization monitoring device includes a base unit with an interactive surface, wherein the interactive surface is configured to record catheterization data. Additionally, the device includes an attachment element associated with the base unit. The device also includes a controller associated with the base unit, wherein the controller is configured to receive catheterization data from the interactive surface and to transmit the catheterization data to a computing device.

[0008] In another aspect, a catheterization monitoring system is provided. The system includes a computing device and a portable catheterization monitoring device. The portable catheterization monitoring device includes a base unit with an interactive surface, wherein the interactive surface is configured to record catheterization data. Additionally, the device includes an attachment element. The device also includes a controller associated with the base unit and is configured to receive catheterization data from the interactive surface and transmit the catheterization data to the computing device. The computing device is configured to receive the catheterization data from the portable catheterization monitoring system, to analyze the catheterization data, and to take an action based on the analyzed catheterization data.

[0009] In yet another aspect, a method of monitoring catheterization is provided. The method includes catheterizing and engaging an interactive surface of a portable catheterization monitoring device to record catheterization data.

BRIEF DESCRIPTION OF DRAWINGS

[0010] FIG. 1 is a front perspective view of an example of a catheterization monitoring device of the present disclosure.

[0011] FIG. 2 is a side perspective view of an embodiment of the catheterization monitoring device.

[0012] FIG. 3 is a schematic view of a catheterization monitoring system including a catheterization monitoring device of the present disclosure.

DETAILED DESCRIPTION

[0013] 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. [0014] Turning to FIG. 1 , this figure shows an example of a catheterization monitoring device 10. The catheterization monitoring device 10 is a portable device configured to monitor catheterization. For instance, the catheterization monitoring device 10 can track a variety of catheterization statistics including, but not limited to, the number of catheterizations, volume of fluid drained, and catheter inventory.

[0015] The catheterization monitoring device 10 includes a base unit 12 associated with an attachment element 14. Accordingly, the attachment element 14 can be used to attach the catheterization monitoring device 10 to a user or other object that the user travels with (e.g., an accessory or a personal mobility device). In the illustrated example, the attachment element 14 is a strap. The user can wear the portable catheterization monitoring device 10 via the strap. For instance, a user may wear the catheterization monitoring device 10 on their wrist like a watch. Alternatively, the strap can be used to attach the catheterization monitoring device 10 to an accessory, such as a purse, bag, backpack, or to a personal mobility device, such as a wheelchair, scooter, or crutches. In another example, the attachment element 14 can be any other suitable element configured to attach a device to a user or object, such as, but not limited to, a clip, a band, or a pin. The attachment element 14 may also include two sub-elements that are attachable by a buckle, snap, hook and loop, etc., similar to a watch band.

[0016] The base unit 12 includes an interactive surface 16. Interactive surface 16 is configured to record catheterization data. In an example, interactive surface 16 includes a display, which provides a visual representation of the catheterization data recorded. Turning to FIG. 2, this figure illustrates an example of the data that can be shown on the display of the interactive surface. For instance, the display may show the time, date, action buttons, and catheterization statistics. The display may show other data as well. In particular, FIG. 2 illustrates a display that shows the time, a catheter inventory count, and action buttons (“back” and “reset”). The display can be configured to show a variety of statistics and actions in any arrangement without departing from the scope of the disclosure. Furthermore, a user may toggle between various displays or may even customize the arrangement of the display using the catheterization monitoring device 10 directly or with a computing device 22 associated with the catheterization monitoring device 10.

[0017] Furthermore, base unit 12 is associated with a controller 15. In an example, controller 15 is housed within the base unit 12. Controller 15 can include a processor, a transceiver module, and other suitable components to receive and send data and to operate the portable catheterization monitoring device 10. Controller 15 is configured to receive the recorded catheterization data from the interactive surface 16 and to transmit the catheterization data to a computing device 22. For instance, a user may interact with the interactive surface 16 to record catheterization or input data. The catheterization data is received by controller 15, analyzed, stored, and/or transmitted to an external computing device 22, such as a smartphone, tablet, or computer.

[0018] Base unit 12 also includes a power supply. For instance, base unit 12 can include a rechargeable battery. Base unit 12 can be charged via a wired connection or wirelessly.

[0019] As discussed above, a user can interact with interactive surface 16 to record catheterization data. In one example, interactive surface 16 is a pressable surface. To record catheterization data with a pressable interactive surface 16, for example, a user may press the interactive surface 16 once to record a catheterization. After catheterization and when the user knows the amount of catheterization fluid drained, the pressable interactive surface 16 can then be pressed a second time and held in the pressed configuration to enter the catheterization fluid volume drained. The amount of time the pressable interactive surface 16 is held in the pressed configuration correlates with the volume of fluid drained. For instance, as the interactive surface 16 is held in the pressed configuration, the display on the interactive surface 16 may show an increasing value corresponding to the volume of fluid drained. In other words, the value displayed increases the longer the interactive surface 16 is held in the pressed configuration. The user would release the interactive surface 16 once the desired fluid volume to be entered is displayed. If the incorrect volume is displayed, the interactive surface may include a reset or adjustment function.

[0020] In another alternative, when urine starts to drain from the bladder, the user presses the interactive surface to start a timer and the interactive surface indicates that drainage has started, such as by showing a timer or displaying a symbol. After drainage from the catheter is finished, i.e., no more urine is flowing through the catheter, the user presses the interactive surface a second time to stop the timer and indicate that drainage is finished. The display then shows a calculated catheterization fluid volume drained during catheterization. This calculated fluid volume is based on a correlation between the drainage time and drained fluid volume. For example, the correlation between the time it takes to drain the bladder and the average urine volume drained during that time may be correlated and preprogrammed into the controller. The calculated volume is recorded and stored in the controller 15.

[0021] Optionally, the correlation may be revised. In one alternative, the correlation may be revised based on user input. For example, if the user knows the actual volume of urine drained (e.g., volume drained into a collection bag or a collection container with fluid measurements markers), the user may use the display to revise the recorded actual volume of drained urine/fluid. The controller 15 then adjusts the correlation based on the actual recorded data. This historical data will allow the user and healthcare provider to track flow rate and volume of catheterization fluid trends.

[0022] In another example, the interactive surface 16 can be pressable and rotatable in relation to the base unit 12. To record catheterization data, the interactive surface 16 is pressed once to record a catheterization. To record volume of urine drained, the interactive surface 16 can be rotated. For instance, as the interactive surface 16 is rotated in one direction (e.g., clockwise), the display on the interactive surface 16 shows an increasing value corresponding to the volume of fluid drained. The user can rotate the interactive surface 16 until the volume of urine drained is shown on the display. Additionally, a user can rotate the interactive surface 16 in an opposite direction (e.g., counterclockwise) to decrease the volume of fluid to be recorded.

[0023] In yet another example, the interactive surface 16 is a touch screen. To record a catheterization, a user may tap the interactive surface 16. After catheterization and when the user knows the amount of catheterization fluid drained, the user can enter the drained fluid volume by dragging their finger in a clockwise or counterclockwise direction on the interactive surface 16 to increase the value of the volume of fluid drained and in the opposite direction to decrease the value shown on the display. Alternatively, the user may tap an action button, such as a “+” or sign on the display to increase or decrease the volume of fluid to be recorded. Without departing from the scope of the disclosure, the interactive touchscreen may be configured to display a variety of action buttons with which the user can interact to record, input, or view data.

[0024] In another alternative, when urine starts to drain from the bladder, the user may tap an action button on the touch screen to start a timer and the interactive surface indicates that drainage has started, such as by showing a timer or displaying a symbol. After drainage from the catheter is finished, i.e., no more urine is flowing through the catheter, the user taps the touch screen a second time to stop the timer and indicate that drainage is finished. The display then shows a calculated catheterization fluid volume drained during catheterization. The calculated fluid volume is based on a correlation between the drainage time and drained fluid volume. For example, the correlation between the time it takes to drain the bladder and the average urine volume drained during that time may be correlated and preprogrammed into the controller. The calculated volume is recorded and stored in the controller 15.

[0025] Optionally, the correlation may be revised. In one alternative, the correlation may be revised based on user input. For example, if the user knows the actual volume of urine drained (e.gr, volume drained into a collection bag or a collection container with fluid measurements markers), the user may use the touch screen to revise the recorded actual volume of drained urine/fluid. The controller 15 then adjusts the correlation based on the actual recorded data. This historical data will allow the user and healthcare provider to track flow rate and volume of catheterization fluid trends. [0026] The portable catheterization monitoring device 10 may also include various features to ease the use of the device for people with limited dexterity. For example, the interactive surface 16 of the base unit 12 can be configured to provide haptic feedback to the user. When the user interacts with the interactive surface 16, the interactive surface 16 can simulate the sense of touch through a vibration, force, or other motion. The portable catheterization monitoring device 10 can also be configured to make a sound as the user interacts with the interactive surface 16. For instance, the interactive surface 16 or base unit 12 can be configured to produce an audible click or other noise to notify the user that an action on the interactive surface 16 has occurred (e.g., pressing, rotating, or tapping the interactive surface 16). Additionally, the portable catheterization monitoring device 10 can include a buzzer or a speaker configured to audibly alert the user. For instance, after a particular number of catheterizations have been recorded, the device can alert the user that their catheter inventory is low.

[0027] The catheterization monitoring device 10 is configured to be associated with a health monitoring system, for example, a catheterization monitoring system 20. FIG. 3 illustrates an exemplary catheterization monitoring system 20, which includes the portable catheterization monitoring device 10. Optionally, the system 20 also includes a computing device 22, 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 number of catheterizations, volume of urine drained, and/or inventory of catheters. Other catheterization statistics can be monitored without departing from the scope of the disclosure.

[0028] For the purpose of establishing effective communication between the user (or environment) and the catheterization monitoring system 20, the base unit 12 of catheterization monitoring device 10 houses a controller 15 and one or more interfaces associated with the controller 15. For example, the controller 15 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 catheterization monitoring device 10 and the external computing device 22, and optionally, directly with a server 28 via a network 26 associated with the catheterization monitoring system 20. The first interface can be coupled to the interactive surface 16, whereas the second interface can be coupled to a transceiver module. In an embodiment, the first and second interfaces may be coupled with controller 15, interactive surface 16, and/or the transceiver module with circuitry.

[0029] The catheterization monitoring device 10 is configured for wireless communication via primary connection 24 with the computing device 22. Accordingly, the catheterization data recorded by catheterization monitoring device 10 can be transmitted to computing device 22 via primary connection 24. Additionally, the computing device 22 is configured to communicate with a server 28 of the catheterization monitoring system 20 via a network 26, such as a cloudbased network. The computing device 22 may be wirelessly connected to server 28 via computing device connection 30. The server 28 may be operated and/or controlled by the catheter manufacturer and/or a service center.

[0030] In an embodiment, after a user has entered catheterization data via the interactive surface 16 to the catheterization monitoring device 10, the data may be transmitted to the computing device 22 via primary connection 24. The data may then be accessed by the user on the computing device 22 and/or further transmitted to the server via computing device connection 30 and server connection 33.

[0031] Optionally, after entering catheterization data via the interactive surface 16 to the catheterization monitoring device 10, the data may be transmitted directly to the server 28 via network 26. For instance, the data may be transmitted to the network 26 via a monitoring device connection 31 and may then be further transmitted to the server 28 via server connection 33.

[0032] The controller 15 further includes the hardware and the firmware that, with the support of program memory and random access memory (RAM), communicates with the interactive surface 16, 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 22. The memory may store the processed data until successful transmission of the data to the external computing device 22 is confirmed.

[0033] The transceiver module provides communication between the catheterization monitoring device 10 to the external computing device 22 and/or directly with the server 28. 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 interactive surface 16, records the data in the memory for further processing by the controller 15. The controller 15 then may generate a transmission signal embedded with the catheterization data to be transmitted to the external computing device 22.

[0034] 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 802.1 1 communication principles and/or similar communication principles may also be used. Catheterization monitoring device 10 or the computing device 22 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.

[0035] The external computing device 22 is equipped with an algorithm such as a mobile app to convert the catheterization monitoring data to meaningful information. For example, the computing device 22 can process the catheterization data, reprocess the data, store the data, retrieve analyzed data, and/or generate reports. In particular, computing device 22 can show catheterization data, such as the number of catheterizations, the volume of urine discharged, and how many catheters remain in the user’s inventory. In other examples, catheterization data are transmitted to the server 28. In another example, the transceiver module transmits raw data to a cloud network 26 and/or server 28, or another device.

[0036] Additionally, it should be noted that various methods and operations are described as being executed by the controller 15 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. [0037] In an example, the monitoring device 10/controller 15 is optionally configured to, in accordance with a determination that the primary connection 24 fails to establish, abort transmitting the catheterization data to the computing device 22 and establish a secondary connection to the server 28, wherein the catheterization data is transmitted via the monitoring device connection 31 to network 26, and from network 26 to server 28 via server connection 33. Establishing a secondary connection may comprise activating an idle or inactive secondary connection.

[0038] Catheterization monitoring device 10 or the computing device 22 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 which is accessible at the healthcare provider end.

[0039] The data transmitted to the computing device 22 and/or server 28 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 22 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 34 via a healthcare provider connection 35 to server 28. Additionally, the catheterization data may be accessed from the computing device 22 or server 28 for a healthcare provider 34 to review. In an example, a healthcare provider 34 may be able to access data from either the portable catheterization monitoring device 10 or the computing device 22 to monitor how frequently a user is catheterizing and/or how much urine is drained during each catheterization. In response, the healthcare provider 34 may be able to send a notification to the user’s computing device 22 or catheterization monitoring device 10. Additionally, the portable catheterization monitoring device and/or computing device may be configured to track a user’s catheter inventory. For example, the computing device 22 may include software (or an app may be configured) to receive data regarding a number of catheters in a user’s inventory. This may be provided to the computing device 22 based on manual input by a user or the computing device 22 may be configured to track orders of catheters. Based on the number of catheterizations recorded, portable catheterization monitoring device 10 and/or computing device 22 may track a user’s catheter inventory by subtracting the number of recorded catheterizations from the catheter inventory. In an embodiment, when catheter inventory data reaches a particular pre-determined threshold (such as when the inventory is running low), portable catheterization monitoring device 10 and/or computing device 22 may alert the user. Additionally, in an embodiment, when catheter inventory reaches a particular threshold or a pre-determined number of catheterizations is recorded, portable catheterization monitoring device 10 and/or computing device 22 may be configured to automatically order additional catheters to refill a user’s catheter inventory. For instance, catheterization monitoring device 10 and/or computing device 22 may send an alert via the network 26 to the catheter manufacturer/provider or healthcare provider 34. By tracking catheterizations, volume of urine drained during catheterization, and catheter inventory with system 20, a catheterization routine and urinary tract health can be more easily maintained and managed.

[0040] 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 catheterization monitoring device comprising: a base unit including an interactive surface, wherein the interactive surface is configured to record catheterization data; an attachment element associated with the base unit; and a controller associated with the base unit, wherein the controller is configured to receive catheterization data from the interactive surface and to transmit the catheterization data to a computing device.

2. The device of claim 1 , wherein the interactive surface includes a display.

3. The device of any of claims 1 -2, wherein the interactive surface is pressable.

4. The device of claim 3, wherein the pressable interactive surface is pressed once to record a catheterization.

5. The device of claim 4, wherein the pressable interactive surface is pressed a second time to record fluid volume.

6. The device of any one of claims 1 -5, wherein the interactive surface is rotatable in relation to the base unit.

7. The device of claim 6, wherein the interactive surface is rotated to record fluid volume.

8. The device of any one of claims 1 -7, wherein the interactive surface includes a touch screen.

9. The device of any one of claim 1-8, wherein the interactive surface provides haptic feedback to a user.

10. The device of any one of claims 1 -9, wherein the base unit includes a buzzer and/or a speaker.

1 1 . The device of any one of claims 1 -10, wherein the attachment element is a strap.

12. A catheterization monitoring system comprising: a computing device; a portable catheterization monitoring device, wherein the portable catheterization monitoring device comprises a base unit including an interactive surface, wherein the interactive surface is configured to record catheterization data; an attachment element; and a controller associated with the base unit and configured to receive catheterization data from the interactive surface and to transmit the catheterization data to the computing device; and wherein the computing device is configured to receive the catheterization data from the portable catheterization monitoring system, to analyze the catheterization data, and to take an action based on the analyzed catheterization data.

13. The system of claim 12, wherein the catheterization data includes at least a number of catheterizations and catheterization fluid volume.

14. The system of any one of claims 12-13, wherein the interactive surface includes a display.

15. The system of any of claims 12-14, wherein the interactive surface is pressable.

16. The system of claim 15, wherein the pressable interactive surface is pressed once to record a catheterization.

17. The system of claim 16, wherein the pressable interactive surface is pressed a second time to record catheterization fluid volume.

18. The system of any one of claims 12-17, wherein the interactive surface is rotatable in relation to the base unit.

19. The system of claim 18, wherein the interactive surface is rotated to record fluid volume.

20. The system of any one of claims 12-19, wherein the interactive surface includes a touch screen.

21 . The system of any one of claims 12-20, wherein the interactive surface provides haptic feedback to a user.

22. The system of any one of claims 12-21 , wherein the base unit includes a buzzer and/or a speaker.

23. The system of any one of claims 12-22, wherein the attachment element is a strap.

24. The system of any one of claims 12-23, wherein the controller transmits the catheterization data to the computing device wirelessly.

25. The system of claim 24, wherein the controller transmits the catheterization data to the computing device using Bluetooth, NFC, or Wi-Fi.

26. The system of claim 24, wherein the controller transmits catheterization data to the internet and the computing device receives the catheterization data from the internet.

27. The system of any one of claims 12-26, wherein the computing device includes an app configured to analyze the catheterization data.

28. The system of any one of claims 13-27, wherein the computing device and/or the portable catheterization monitoring device alerts the user based on the catheterization data.

29. The system of any one of claims 13-28, wherein the computing device is configured to automatically order new catheters when a pre-determined number of catheterizations is received from the portable catheterization monitoring device.

30. A method of monitoring catheterization comprising: catheterizing; and engaging an interactive surface of a portable catheterization monitoring device to record catheterization data.

31 . The method of claim 30, wherein the catheterization data is at least a number of catheterizations and/or catheterization fluid volume.

32. The method of claim 31 , further comprising pressing the interactive surface once to record a catheterization.

33. The method of claim 32, further comprising pressing the interactive surface a second time and holding the interactive surface in a pressed configuration to record catheterization fluid volume.

34. The method of any one of claims 31 -33, further comprising rotating the interactive surface to record catheterization fluid volume.

35. The method of any one of claims 30-34, wherein the portable catheterization monitoring device comprises a base unit including the interactive surface; an attachment element associated with the base unit; and a controller associated with the base unit, wherein the controller is configured to receive the catheterization data from the interactive surface and to transmit the catheterization data to a computing device.

36. The method of any one of claims 30-35, wherein the interactive surface includes a display.

37. The method of any one of claims 30-36, wherein the interactive surface includes a touch screen.

38. The method of claim 37, comprising engaging the touch screen to record catheterization data.

39. The method of any one of claims 30-38, wherein the interactive surface provides haptic feedback to a user.

40. The method of any one of claims 35-39, wherein the base unit includes a buzzer and/or a speaker.

41 . The method of any one of claims 35-40, wherein the attachment element is a strap.