Urinary catheter system and method

Abstract

The present disclosure describes a urinary catheter attachment with a sensor and microcontroller that monitors bladder parameters, such as pressure or volume, and determines when the bladder is full and should be voided. In various embodiments, the disclosed system enables individuals who are unable to know, feel, or remember when their bladder should be voided to use a catheter accessory, such as a catheter valve. According to various embodiments, the system calculates bladder fullness through an algorithm and triggers an alert system when a bladder fill threshold is exceeded. In various embodiments, the alert system includes, but is not limited to, notifications via a smartphone or smart device, wearable technology, and patient management system. The alert system may be replaced with an electronically actuated catheter valve. The alert system may be replaced with an electronically actuated catheter valve.

Description

[Technical field]

[0001] This application relates to a urinary catheter system and method. This application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 067,689, filed August 19, 2020, entitled "Catheter Accessory System and Method for Monitoring, Detecting, and Notifying Bladder Fullness for Controlled Voiding," which is incorporated herein by reference in its entirety. [Background technology]

[0002] Urinary incontinence, a condition resulting from affected bladder sphincter control, is often managed using a urinary catheter to assist with bladder voiding. Urethral catheters drain urine from the bladder when an individual is unable to void urine on their own, such as after surgery or the onset of disease. These catheters can be classified as either intermittent catheters, where the catheter is removed after bladder voiding is complete, or indwelling catheters, where the catheter remains in place between bladder voiding.

[0003] The two most common types of indwelling urinary catheters are suprapubic and urethral catheters. Both consist of a hollow flexible tube. Suprapubic catheters are inserted into the bladder through a stoma, whereas urethral catheters, commonly called Foley catheters, are inserted into the bladder through the urethra. Both indwelling catheter types have a balloon at one end that is inserted into the bladder and expanded to secure the catheter therein. The end of the balloon also has one or more eyelets, or openings, at the tip of the catheter that allow for urination. The outer (distal) end of the catheter is connected to a collection bag, a valve, or similar device that can be opened and / or closed or removed and / or replaced to allow drainage, or to another catheter drainage device.

[0004] Several studies have shown that the incidence of catheter-associated UTI (CAUTI) is higher in users of urine collection bags compared to users of catheter valves. CAUTI is a significant medical problem that has a significant impact on health care costs and quality of life for patients. CAUTI is an infection of the urinary tract caused by catheter use. Some of these studies hypothesize that the benefit of using a valve, plug, or cap instead of a drainage bag is related to increased urinary flow when the valve is periodically opened at naturally occurring intervals. These studies are inherently limited because many indwelling catheter users are unable to use catheter valves due to limited bladder sensation or dexterity. This prevents patients from testing the effects of such techniques, as they cannot know when to open the valve to drain the bladder.

[0005] In the subset of patients who can choose between a collection bag and a catheter valve with an indwelling catheter, nearly three-quarters of patients prefer to use the valve. The valve is less noticeable, provides greater mobility, and improves the patient's overall quality of life. In addition, the valve prevents further bladder compromise and contraction that can typically occur while using a collection bag. While the small, unnoticeable valve profile is an immediate benefit to the patient, maintaining the physiological process of bladder filling and emptying is a major physiological benefit.

[0006] Intermittent catheterization is an alternative to indwelling catheterization. The patient or caregiver inserts an intermittent catheter at specific time intervals when the patient's bladder is full or has insufficient sensation to empty the bladder. This alternative has become popular due to its ability to reduce catheter-associated UTIs. Intermittent catheterization can be difficult for individuals with mobility or dexterity issues. A prospective study offered a system that included an indwelling catheter and a catheter valve as an alternative to intermittent catheterization for periods up to 8 hours per day. The study showed preliminary data that using an indwelling catheter with a valve for a period of time each day may improve quality of life without substantially increasing CAUTI risk compared to intermittent catheterization. The study also showed that more than half of the individuals in the study preferred an indwelling catheter with a valve.

[0007] Emptying the bladder at specified intervals fails to account for fluctuations in fluid intake or output, such as those caused by drinking water or sweating during exercise, which can result in the bladder being emptied more or less frequently than desired.

[0008] Thus, there exists a long-felt unmet need for a system or method that allows patients with limited bladder sensation to empty their bladders at appropriate intervals using a catheter valve, plug, cap, or similar device and receive the same benefits as individuals with bladder sensation. Summary of the Invention

[0009] Briefly, according to one embodiment, aspects of the present disclosure generally relate to systems and methods for detecting bladder fullness in a patient using a catheter system. In at least one embodiment, the system includes a urinary catheter attachment that can be used in-line with indwelling urinary catheters, such as urinary catheters and suprapubic catheters, and urinary catheter accessories, including catheter valves and catheter drainage valves. In certain embodiments, the system of the present disclosure can detect when a user's bladder is at capacity and then alert the user or caregiver to empty their bladder. In at least one embodiment, the system of the present disclosure includes a component that allows connection to an existing catheter tube end, a component that allows connection to an existing catheter accessory device, one or more components that can detect and analyze bladder signals, and a component that generates and delivers alerts based on those signals.

[0010] The technology may be beneficial for patients who experience other problems such as compliance or mobility. For example, it may be particularly beneficial for indwelling catheter users who cannot accurately remember when to empty their bladder. The system may also benefit intermittent catheter users who struggle to travel to the bathroom or have memory problems regarding the bladder voiding cycle. The proposed technology may also be useful for clinicians who need consistent and reliable data on their patients' bladder dynamics to monitor and improve treatment. The system and approach outlined herein may have future applications to the field of ambulatory urodynamics.

[0011] According to a first aspect, a urinary catheter system includes A) a rear element for receiving a catheter, the rear element defining 1) a rear opening having a first diameter, 2) a mating end opening having a second diameter, and 3) a core opening within a hollow interior, the core opening having the second diameter, the rear element having i) the hollow interior extending from the rear opening to the mating end opening, ii) an outer surface, and iii) a mating end extending from the outer surface proximate the mating end opening; and B) a front element defining a front opening and an inner opening, coupled to the rear element proximate the inner opening, the front opening and the inner opening defining 1) a front hollow interior between the front opening and the inner opening. 2) the front element having a port between the front opening and the inner opening, the port being located at least 2 centimeters from the front opening, for receiving a measurement housing component, and 3) a constant diameter between the inner opening and the port; and C) the measurement housing component operably connected to the front element, the measurement housing component having: 1) one or more transducers for measuring hydrostatic pressure data within the front hollow interior, and 2) at least one transmitter for transmitting the hydrostatic pressure data to a computing system for calculating bladder fill level.

[0012] According to a further aspect, in the urinary catheter system of the first aspect or any other aspect, A) the joint end has a joint end outer surface, and B) a diameter of the joint end at the joint end outer surface is greater than the constant diameter of the front hollow interior.

[0013] According to a further aspect, in the urinary catheter system of the first aspect or any other aspect, the measurement housing component extends through an outer wall of the front element into the front hollow interior via the port.

[0014] According to a further aspect, in the urinary catheter system of the first aspect or any other aspect, the one or more transducers measure the hydrostatic pressure of urine within the front hollow interior.

[0015] According to a further aspect, in the urinary catheter system of the first aspect or any other aspect, the bladder filling level is calculated by comparing the hydrostatic pressure data to a threshold value.

[0016] According to a further aspect, in the urinary catheter system of the first aspect or any other aspect, the bladder fill level is calculated based on filtered hydrostatic pressure data.

[0017] According to a further aspect, in the urinary catheter system of the first aspect or any other aspect, the computing system is configured to send an alert to a user device when it determines that the bladder fill level has reached a certain threshold.

[0018] According to a further aspect, in the urinary catheter system of the first aspect or any other aspect, the constant diameter of the front hollow interior is greater than or equal to the second diameter of the joint end opening.

[0019] According to a further aspect, in the urinary catheter system of the first aspect or any other aspect, the second diameter is greater than the first diameter. According to a further aspect, in the urinary catheter system of the first aspect or any other aspect, A) the second diameter is equal to the first diameter, and B) the outer diameter of the rear element is tapered toward the rear opening.

[0020] According to a second aspect, a method comprises: A) receiving, in one or more processors, hydrostatic pressure data associated with a volume of urine in a urinary catheter system derived from one or more transducers via a port through an outer wall of a catheter mounting component; B) calculating a bladder fill level based on the hydrostatic pressure data; C) comparing the bladder fill level to a predetermined threshold; and D) sending an alert to a user device upon determining that the bladder fill level exceeds the predetermined threshold.

[0021] According to a further aspect, in the method of the second aspect or any other aspect, the predetermined threshold is user specific. According to a further aspect, in the method of the second aspect or any other aspect, calculating the bladder fill level includes filtering the hydrostatic pressure data.

[0022] According to a further aspect, in the method of the second aspect or any other aspect, A) the hydrostatic pressure data includes a hydrostatic pressure parameter, and B) calculating the bladder fill level includes comparing the hydrostatic pressure parameter to historical hydrostatic pressure data associated with various bladder fill levels.

[0023] According to a further aspect, in the method of the second aspect or any other aspect, the one or more transducers are contained within a measurement housing component operably connected to the catheter mounting component via the port.

[0024] According to a further aspect, in the method of the second aspect or any other aspect, A) the catheter mounting component comprises a rear element and a front element, B) the front element includes a port, and C) the measurement housing component is operably connected to the front element via the port.

[0025] According to a further aspect, in the method of the second aspect or any other aspect, the rear element and the front element are integrally formed. According to a further aspect, in the method of the second aspect or any other aspect, the rear element has at least two different inner diameters.

[0026] According to a further aspect, in the method of the second aspect or any other aspect, the rear element is configured for at least partial insertion into a urinary catheter. According to a further aspect, in the method of the second aspect or any other aspect, the leading element is configured for operative connection to a catheter end accessory.

[0027] These and other aspects, features and advantages of the claimed invention will become apparent from the following detailed description of the preferred embodiments and aspects taken in conjunction with the following drawings, although variations and modifications thereto may be made without departing from the spirit and scope of the novel concepts of the present disclosure. [Brief description of the drawings]

[0028] [Figure 1] FIG. 1 is a perspective view of a bladder fullness detection system according to one embodiment of the present disclosure. [Diagram 2] FIG. 2 is a perspective view of a bladder fullness detection system according to one embodiment of the present disclosure. [Figure 3A] FIG. 3A is a first side view of a bladder fullness detection system according to one embodiment of the present disclosure. [Figure 3B] FIG. 3B is a second side view of a bladder fullness detection system according to one embodiment of the present disclosure. [Figure 4A] FIG. 4A is a top view of a bladder fullness detection system according to one embodiment of the present disclosure. [Figure 4B] FIG. 4B is a bottom view of a bladder fullness detection system according to one embodiment of the present disclosure. [Diagram 5] FIG. 5 is an exploded view of a bladder fullness detection system according to one embodiment of the present disclosure. [Figure 6]FIG. 6 illustrates a system architecture of a measurement device of a bladder fullness detection system according to one embodiment of the present disclosure. [Figure 7A] FIG. 7A is an anatomical diagram illustrating a bladder fullness detection system inserted into the bladder, according to one embodiment of the present disclosure. [Figure 7B] FIG. 7B is an anatomical diagram illustrating a bladder fullness detection system inserted into the bladder, according to one embodiment of the present disclosure. [Figure 8] FIG. 8 illustrates a flowchart of a use case of the bladder fullness detection system, according to one embodiment of the present disclosure. [Figure 9] FIG. 9 illustrates a flowchart of a method of a bladder fullness detection system according to one embodiment of the present disclosure. [Figure 10] FIG. 10 is a diagram illustrating a measurement device pairing environment according to one embodiment of the present disclosure. [Figure 11] FIG. 11 is a diagram illustrating a user customizable notification editor according to one embodiment of the present disclosure. [Figure 12] FIG. 12 illustrates a notification interval editor according to one embodiment of the present disclosure. [Figure 13] FIG. 13 illustrates an exemplary dashboard for a user to interface with device data, according to one embodiment of the disclosure. [Figure 14] FIG. 14 is a diagram illustrating a notification on a client device according to one embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] The accompanying drawings illustrate one or more embodiments and / or aspects of the present disclosure and, together with the detailed description of the invention, serve to explain the principles of the present disclosure. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or similar elements of the embodiments. Whether or not a term is capitalized is not to be construed as determining or limiting the meaning of the term. Capitalized terms, as used herein, shall have the same meaning as non-capitalized terms, unless the context of their use specifically indicates that a more limiting meaning is intended for the capitalized term. However, capitalized terms in the remainder of this specification are not necessarily intended to be limiting, unless the context clearly indicates that such a limitation is intended.

[0030] In order to promote the understanding of the principles of the present disclosure, the following will refer to the embodiments shown in the drawings and use specific language to describe the embodiments. However, it can be understood that the scope of the present disclosure is not limited by the embodiments. Any changes and further modifications of the embodiments described below or shown in the drawings, and any further applications of the principles of the present disclosure shown in the drawings are contemplated as would normally occur to a person skilled in the art to which the present disclosure pertains. All limitations of scope should be determined according to the claims and as set forth in the claims.

[0031] [overview] Aspects of the present disclosure generally relate to systems and methods for determining a patient's bladder fullness using a catheter system. In at least one embodiment, the system of the present disclosure includes a urinary catheter attachment that can be used in-line with urinary catheters, such as urinary catheters and suprapubic catheters, and urinary catheter accessories, including catheter valves and catheter drainage valves. In certain embodiments, the system of the present disclosure can detect when a user's bladder is at capacity and then alerts the user or caregiver to empty their bladder. In at least one embodiment, the system of the present disclosure includes a component that allows connection to an existing catheter tube end, a component that allows connection to an existing catheter accessory device, one or more components that can detect, record, and analyze bladder signals, a component that generates and delivers alerts based on those signals, and a component that allows the user and others identified by the user to view and interact with the bladder signals and analysis results reports.

[0032] In certain embodiments, the system of the present disclosure includes a single sensor (e.g., a pressure sensor) or an array of sensors (e.g., a pressure array, a flow array, and a conductance sensor) that measure physiological characteristics of urine and bladder dynamics. In some embodiments, data from the sensors is used in an algorithm to determine when to empty the individual's bladder. In certain embodiments, the algorithm type includes simple thresholds or more complex data processing models (e.g., regression models, machine learning, or artificial intelligence). In various embodiments, data processing occurs on a measurement device, a client device, a dedicated computing environment, and / or a combination of previous computing sources. In at least one embodiment, data collected by the system of the present disclosure is monitored, recorded, and transmitted to an appropriate data storage component. In various embodiments, the data storage component can be resident within the measurement device, the client device, and / or the dedicated computing environment. In one or more embodiments, data generated by the system of the present disclosure is analyzed by those involved in the user's medical care (e.g., the user, the user's caregivers, or the user's medical team). In some embodiments, the system of the present disclosure analyzes the stored data to construct clinically relevant reports, such as a bladder diary detailing how often and how much the patient voids the bladder, plots of changes in bladder pressure or compliance over short or long term, and / or any other relevant reports. In one or more embodiments, the system of the present disclosure connects to a catheter and performs its functions non-invasively to the user.

[0033] In various embodiments, the data processing system, notification system, data storage system, or combination of these systems are located on one or a combination of a measurement device, a wearable device, a client device (e.g., a phone or tablet), a local computing environment, and / or a cloud computing environment. In some embodiments, the system of the present disclosure may provide multiple notifications to ensure that the user empties the bladder at the appropriate time. In various embodiments, the system of the present disclosure provides early notifications to ensure that the user has enough time to find a suitable place to empty the bladder. In certain embodiments, the system of the present disclosure provides early notifications to help users who need more time to find a suitable urination location due to a condition such as a mobility disorder. In at least one embodiment, the system of the present disclosure is programmed to "train" the bladder by gradually increasing the duration or bladder fullness between urination intervals, potentially expanding the bladder. In one or more embodiments, the expansion of the bladder, the increase in the time interval between urinations, and / or the increase in bladder fullness increases bladder capacity over time. In various embodiments, the disclosed system takes into account user-specific parameters measured or manually entered via an interface to optimize the system for a particular user. In at least one embodiment, the disclosed system includes a step of considering artifacts in the collected data. In one or more embodiments, the step for artifact recognition may include the use of high-pass or low-pass filters or other models to reduce the data to its relevant information.

[0034] Exemplary embodiments Reference is now made to the drawings. To illustrate and describe the basic processes and components of the systems and methods of the present disclosure, reference is made to FIG. 1, which shows a perspective view of a catheter system 100. As can be understood and appreciated, the exemplary catheter system 100 shown in FIG. 1 represents only one approach or embodiment of the system, and other aspects are used according to various embodiments of the system. In some embodiments, the exemplary catheter system 100 includes a catheter tube 101, a balloon 103, a balloon port 104, a catheter valve 102, and a bladder fullness detection system 200. In one or more embodiments, the catheter tube 101 includes various lumens (not shown) that are specific channels for liquid flow. For example, there may be a lumen dedicated to urine flow and a separate lumen for saline flow to the balloon 103.

[0035] As can be understood from the description herein, the system can include any suitable catheter end accessory. The catheter end accessory can be any device, system, and / or component that is conventionally operatively disposed at the end of a catheter. In at least one embodiment, the catheter end accessory can be a drainage bag, a catheter valve 102, a plug, or other catheter drainage accessory.

[0036] In various embodiments, the balloon 103 is anchored to the bladder by filling and expanding with saline solution. In some embodiments, anchoring the balloon 103 prevents the catheter tube 101 from slipping out of the body. In certain embodiments, the catheter tube 101 is inserted into the bladder before inflating the balloon 103. In various embodiments, the balloon 103 is inflated when a syringe inputs fluid through a balloon port 104 that connects to the balloon 103 through a lumen. In some embodiments, following insertion of the catheter tube 101 into the bladder and balloon inflation, another lumen of the catheter tube 101 connects to a bladder fullness detection system 200. In one or more embodiments, the lumen uses an externally visible interface at the mating end 111 to connect with the bladder fullness detection system 200.

[0037] In certain embodiments, the mating end 111 is a physical protuberance on the bladder fullness detection system 200. In one or more embodiments, the mating end 111 acts as a stop, preventing the bladder fullness detection system 200 from going any further inside the catheter tube 101 during installation or use. The catheter tube 101 can be connected to the bladder fullness detection system 200 by sliding the two components together until the catheter tube 101 contacts the mating end 111. In certain embodiments, once the catheter tube 101 is connected to the bladder fullness detection system 200, the catheter valve 102 connects to the bladder fullness detection system 200.

[0038] In some embodiments, the components are connected by first connecting the bladder fullness detection system 200 to the catheter valve 102. Continuing with this embodiment, the bladder fullness detection system 200 is attached to the catheter tube 101 once the catheter tube 101 has been inserted into the bladder and secured using the catheter balloon 103.

[0039] In some embodiments, the bladder fullness detection system 200 operates outside of the bladder. In various embodiments, the bladder fullness detection system 200 is separate from the system that measures and operates within the bladder.

[0040] In certain embodiments, the catheter valve 102 is manually or automatically opened and closed to allow urine to drain and stop urine from flowing out. In one or more embodiments, when the catheter valve 102 is in an open state, the catheter valve 102 drains urine. In some embodiments, the catheter valve 102 closes to prevent urine from flowing out when the bladder is emptied. In various embodiments, the catheter valve 102 is mechanically controlled by a measurement device 606 (see FIG. 6 ) to automatically drain urine or prevent urine from flowing out.

[0041] In certain embodiments, when the catheter valve 102 is closed, a hydrostatic pressure column is generated. In at least one embodiment, the hydrostatic pressure column is continuous through the catheter valve 102, the bladder fullness detection system 200, the catheter tube 101, and the user's bladder. In certain embodiments, the hydrostatic pressure column does not have any discontinuities throughout the components described herein. In one or more embodiments, a continuous hydrostatic pressure column throughout the catheter system 100 facilitates detection or calculation of a parameter such as the height of fluid above a measurement point. In various embodiments, when the height of fluid above a measurement point is known, the bladder fullness detection system 200 can determine the height of fluid in the bladder. In certain embodiments, the bladder fullness detection system 200 electronically detects the hydrostatic pressure and calculates the height of fluid above it to determine the bladder fill level. In various embodiments, the sensor array may measure other relevant parameters when the catheter valve 102 is opened or closed (e.g., urine flow rate, electrolyte concentration, presence of bacteria, whether the catheter valve is open or closed, etc.).

[0042] In some embodiments, bladder fullness detection system 200 measures and analyzes relevant parameters within bladder fullness detection system 200 and / or on system architecture 600. In one or more embodiments, bladder fullness detection system 200 may be disposable or reusable, or may include components that are a combination of reusable and disposable.

[0043] 2, a perspective view of a bladder fullness detection system 200 is shown. In one or more embodiments, the bladder fullness detection system 200 includes a rear hollow element 202, a front hollow element 201, and a measurement component housing 203. In various embodiments, the rear hollow element 202, the front hollow element 201, and the measurement component housing 203 are made from similar materials.

[0044] In some embodiments, the rear hollow element 202, the front hollow element 201, and the measurement component housing 203 are made of different materials. The bladder fullness detection system may include, but is not limited to, latex, silicone, polypropylene, polyethylene, and polycarbonate. In certain embodiments, the components of the bladder fullness detection system are manufactured using 3D printing, rotational molding, injection molding, casting molding, thermoforming, and / or any other suitable manufacturing process. In various embodiments, any combination of components is manufactured as one component or multiple components. In at least one embodiment, the rear hollow element 202 and the front hollow element 201 are a single piece (e.g., integrally formed).

[0045] In some embodiments, the rear hollow element 202 is inserted into the distal end of the catheter tube 101 (e.g., receives the catheter tube 101). In at least one embodiment, the rear hollow element 202 and the catheter tube 101 have substantially the same diameter. In certain embodiments, having substantially the same diameter between the rear hollow element 202 and the catheter tube 101 promotes proper sealing. In some embodiments, the rear hollow element 202 has a larger diameter than the catheter tube 101. In various embodiments, the rear hollow element 202 is made of a high friction material to promote sealing between the rear hollow element 202 and the catheter tube 101. According to certain embodiments, the surface of the rear hollow element 202 includes one or more ridges, spines, or other surface features to promote friction between the rear hollow element 202 and the catheter tube 101 (when the catheter tube 101 is operably connected to the rear hollow element 202).

[0046] In one or more embodiments, the rear hollow element 202 includes a rear end 222 and a rear opening 212. In at least one embodiment, the rear opening 212 serves as an opening for the inflow of urine from the catheter 101.

[0047] In some embodiments, the front hollow element 201 connects to the catheter valve 102 and / or a particular catheter mounting system. In various embodiments, the front hollow element 201 has a diameter similar to the diameter of the distal end of the catheter valve 102. The mechanical seal between the front hollow element 201 and the catheter valve 102 can be substantially similar to the mechanical seal between the rear hollow element 202 and the catheter tube 101.

[0048] In some embodiments, the mechanical seal between the leading hollow element 201 and the catheter valve 102 may include clamping, gluing, chemical sealing, friction-based sealing, threaded sealing, and / or any other suitable sealing technique. In at least one embodiment, the leading hollow element 201 and the catheter valve 102 may be integrally formed. As can be understood from the description herein, the leading hollow element 201 may be integrally formed with the catheter end accessory (including the catheter valve 102 or other accessory) and / or the trailing element 202.

[0049] In some embodiments, the rear hollow element 202 includes a mating end 111. In various embodiments, the mating end 111 has a larger diameter than the rear hollow element 202 that is equal to the inner or outer diameter of the catheter tube 101. In at least one embodiment, the mating end 111 functions as a stop to ensure that the rear hollow element 202 is inserted a sufficient amount into the catheter tube 101. In certain embodiments, the mating end 111 provides a surface area for mating various components during manufacturing and assembly. The front hollow element 201 and the rear hollow element 202 may have a similar inner diameter as the catheter tube 101 to promote similar drainage rates throughout the system.

[0050] In one or more embodiments, the front hollow element 201 includes a front end 221 and a front opening 211. The front opening 211 of the front hollow element 201 receives the catheter valve 102. In certain embodiments, the front end 221 remains outside of the catheter valve 102 or similar device inserted into the front hollow element 201. In some embodiments, the rear end 222 remains inside the catheter tube 101 when the rear hollow element 202 and the catheter tube 101 are connected.

[0051] In one or more embodiments, the measuring component housing 203 includes a single or multiple transducers (e.g., pressure, light, conductance) that protrude from the measuring component housing 203 and connect through a port 501 (see FIG. 5) on the side of the front hollow element 201. In some embodiments, the measuring component housing 203 further includes a transmitter for relaying information between components of the system architecture 600 (see FIG. 6). In various embodiments, the measuring component housing can be located at least about 2.0 cm, 3.0 cm, 2.0-5.0 cm, 3.0-4.0 cm, 4.0-5.0 cm, or less than about 5.0 cm from the front opening 211, as indicated by the length 231. As can be understood from the description herein, the length 231 can extend from the front opening 211 to a central portion of the measuring component housing and / or port 501 (shown in FIG. 5). In various embodiments, the length 231 allows for full insertion of the drainage accessory without covering the insertion port. In some embodiments, the measuring component housing 203 is removable and reusable with new bladder fullness detection system 200 components. The measuring component 203 may also include a microcontroller, a battery, and a Bluetooth transmitter and / or other wireless transmitter.

[0052] 3A, a first side view of a bladder fullness detection system 200 is shown in accordance with one embodiment of the present disclosure. In at least one embodiment, the bladder fullness detection system 200 includes a rear hollow element 202 that begins at a small diameter and gradually increases in diameter to its maximum diameter approximately halfway between the rear end 222 and the mating end 111. In certain embodiments, the first diameter 311A ​​can be at least about 2.0 mm, 2.0-5.0 mm, 2.0-3.0 mm, 3.0 mm, 3.0-4.0 mm, 4.0-5.0 mm, or less than about 5.0 mm. In some embodiments, the second diameter 312A can be at least about 5.0 mm, 5.0-9.0 mm, 5.0-6.0 mm, 6.0 mm, 6.0-7.0 mm, 7.0-8.0 mm, 8.0-9.0 mm, or less than about 9.0 mm. In various embodiments, the third diameter 313A can be at least about 8.0 mm, 8.0-13.0 mm, 8.0-9.0 mm, 9.0-10.0 mm, 10.0-11.0 mm, 11.0-12.0 mm, 12.0 mm, 12.0-13.0 mm, or less than about 13.0 mm. In one or more embodiments, the second diameter 312A is located approximately midway between the first diameter 311A ​​and the third diameter 313A. In some embodiments, the second diameter 312A has a diameter larger than the first diameter 311A ​​but smaller than the third diameter 313A. In various embodiments, the rear half of the rear hollow element 202 includes a fourth diameter 314A. In certain embodiments, the size of the fourth diameter 314A is substantially the same as the size of the third diameter 313A. In one or more embodiments, the rear hollow element 202 increases in diameter from a first diameter 311A ​​to a third diameter 313A to form a seal between the rear hollow element 202 and the catheter tube 101. The rear hollow element 202 may have an outer silicone or latex layer to promote a greater seal with the catheter tube 101.

[0053] In some embodiments, the length 316A is at least about 8.0 cm, 8.0-12.0 cm, 8.0-10.0 cm, 10.0 cm, 10.0-12.0 cm, or less than about 12.0 cm. In one or more embodiments, the length 316A may vary but be substantially sufficient to facilitate measurement by the measuring device 606 (see FIG. 6 ) when the catheter valve 102 (or other catheter end accessory) and catheter tube 101 are attached.

[0054] In some embodiments, the front element diameter 315A can be at least about 10.0 mm, 10.0-11.0 mm, 10.0-10.5 mm, 10.5-11.0 mm, or less than about 11.0 mm. In various embodiments, the front element diameter 315A fits standard urinary catheter end accessories. The front hollow element 201 can have an internal silicone or latex layer to promote a greater seal with the urinary catheter end accessory. In at least one embodiment, the front hollow element 201 has one or more internal diameters that are tapered to allow for a secure fit with the urinary catheter end accessory.

[0055] The measuring component housing 203 can include housing edges 321A and housing corners 322A. In one or more embodiments, the housing corners 322A and the housing edges 321A are rounded to prevent snagging on clothing or accessories and to prevent irritation. In various embodiments, the measuring component housing 203 is manufactured in multiple pieces, for example, with seams between the component housing body, the housing edges 321A, and the housing corners 322A. In some embodiments, the measuring component housing 203 is manufactured as one complete piece.

[0056] 3B, a second side view of a bladder fullness detection system 200 according to one embodiment of the present disclosure is shown. In certain embodiments, the device has a rear hollow element 202 that couples and fits to an exposed portion of a urinary catheter. In various embodiments, the front hollow element 201 can be glued or attached to the rear hollow element 202. In some embodiments, the rear hollow element 202 and the front hollow element 201 are made using a combination of elastic material (e.g., rubber or latex) and rigid material (e.g., plastic). In at least one embodiment, the front hollow element 201, the rear hollow element 202, and the mating end 111 are manufactured as a single piece (e.g., integrally formed). In one or more embodiments, the measuring component housing 203 is attached to the front hollow element 201.

[0057] In certain embodiments, the rear hollow element 202 of the bladder fullness measurement system 200 has two portions. In some embodiments, the first hollow element half 301B gradually increases in diameter from the rear end 222 to the rear hollow element junction 321B. In certain embodiments, the rear hollow element junction 321B has substantially the same diameter as the fourth diameter 314A (see FIG. 3A). In some embodiments, the first hollow element half 301B is attached to the second hollow element half 302B. In various embodiments, the first hollow element half 301B extends from the first diameter 311A ​​to a third diameter 313A. In at least one embodiment, the third diameter 313A transitions to the fourth diameter 314A of the second hollow element half 302B. In one or more embodiments, the second hollow element half 302B has a consistent diameter equal to the fourth diameter 314A.

[0058] In some embodiments, the gradually increasing taper of the first hollow element half 301B facilitates connection between the rear hollow element 202 and the catheter tube 101. In various embodiments, the rear hollow element 202 has a length 312B of at least about 3.0 cm, between 3.0 and 4.0 cm, or less than about 4.0 cm. In certain embodiments, the length 312B varies to improve fit with different types of catheters. The first diameter 311A, the second diameter 312A, the third diameter 313A, and the fourth diameter 314A may vary to improve fit with a selected catheter.

[0059] The mating end 111 may function as a stop to prevent over-insertion of the bladder fullness detection system 200 into the catheter tube 101. The mating end diameter 311B may be larger than the fourth diameter 314A of the rear hollow element 202 by at least an amount approximately equal to the thickness of the catheter tube 101. In certain embodiments, the mating end diameter 311B is larger than the inner diameter of the catheter tube 101 but smaller than the outer diameter of the catheter tube 101.

[0060] In some embodiments, the connection between the first hollow element half 301B and the second hollow element half 302B is defined as the rear hollow element joint 321B. In certain embodiments, the rear hollow element 202 is manufactured as one component or multiple components that are then joined at the rear hollow element joint 321B. In some embodiments, the rear hollow element 202 is manufactured as one complete component. In various embodiments, the diameter of the rear hollow element joint 321B is substantially the same as the fourth diameter 314A of the rear hollow element 202. In at least one embodiment, the rear hollow element joint 321B is smooth and unobtrusive, except to accentuate the transition area from the first hollow element half 301B to the second hollow element half 302B.

[0061] 4A, a top view of the bladder fullness detection system 200 is shown according to one embodiment of the present disclosure. In various embodiments, the measurement component housing 203 has an outer shell 401A made of a soft medical grade material that protects the internal measurement device 606 (see FIG. 6) and provides comfort to the wearer. The rear inner diameter 411A is defined as the difference between the first diameter 311A ​​and the material thickness of the rear hollow element 202. In some embodiments, the rear inner diameter 411A is at least about 2.0 mm, 2.0-8.0 mm, 2.0-4.0 mm, 4.0-6.0 mm, 6.0-8.0 mm, or less than about 8.0 mm.

[0062] 4B, a bottom view of the bladder fullness detection system 200 is shown according to one embodiment of the present disclosure. In at least one embodiment, the measurement component housing 203 is attached to a connection tube 402B that protrudes perpendicularly to the front hollow element 201. In one or more embodiments, the connection tube 402B facilitates a continuous connection to a fluid column. In certain embodiments, the measurement device 606 (see FIG. 6) measures the pressure present within the connection tube 402B. In some embodiments, the anchor element 401B fits into the front inner diameter 412B of the front hollow element 201. In various embodiments, the inner diameter 411B is substantially the same as the fourth diameter 314A of the rear hollow element 202. The front inner diameter 412B can be the difference between the front hollow element diameter 315A and the material thickness of the front hollow element 201. The front inner diameter 412B can be at least about 10.0 mm, between 10.0 and 11.0 mm, or less than about 11.0 mm to accommodate the majority of catheter valves or other catheter end accessories.

[0063] The connecting tube 402B for the measuring component housing 203 may have a diameter of at least about 0.5 mm, 0.5-5.0 mm, 0.5-2.5 mm, 2.5-5.0 mm, or less than about 5.0 mm. In various embodiments, the diameter of the connecting tube 402B is comparable to the size of the transducer it contains. In at least one embodiment, the diameter of the connecting tube 402B is determined to improve accessibility for a user to handle the measuring component housing 203. In at least one embodiment, the anchor element 401B may have a diameter of at least about 5.0 mm, 5.0-6.0 mm, or less than about 6.0 mm. In various embodiments, the diameter of the anchor element 401B is selected to facilitate fixation of the measuring component housing 203 to the front hollow element 201 without exceeding the inner diameter 412B.

[0064] 5, an exploded perspective view of a bladder fullness detection system 200 is shown according to one embodiment of the present disclosure. In various embodiments, the rear hollow element 202 has a rear opening 212 that allows fluid to flow from the urinary catheter. In some embodiments, the rear hollow element 202 has a draft beveled tip 521 that allows easy insertion into the distal hollow end of the urinary catheter. The rear hollow element 202 may have a joint end 111 at its base to prevent the catheter tube 101 from advancing any further. In some embodiments, the joint end 111 and its joint end diameter 311B (see FIG. 3B) have different dimensions to accommodate different catheters. In certain embodiments, the front hollow element 201 meets the rear hollow element 202 at the joint end 111. In various embodiments, the front hollow element 201 has a port 501 to which the measurement component housing 203 is secured. In at least one embodiment, the measuring component housing 203 includes an anchor element 401B that keeps the measuring component housing 203 fixed to the front hollow element 201. In some embodiments, the anchor element 401B is removable from the front hollow element 201. In one example, fluid enters the device through the rear opening 212 of the rear hollow element 202 and exits through the front opening 211 of the front hollow element 201. In certain embodiments, the end of the front opening 211 has an inner diameter 412B (see FIG. 4B) that is compatible with standard catheter end accessories.

[0065] In various embodiments, the front element inner surface 522 is tapered to allow for easy insertion of a catheter end accessory. In one or more embodiments, the front element inner surface 522 increases in diameter from the front opening 211 to the front element inner opening 513, or from the front opening 211 to another location, such as the port 501. For example, the diameter of the front opening 211 is smaller than the diameter of the front element inner opening 513. In some embodiments, the front element inner surface 522 decreases in diameter from the front opening 211 to the front element inner opening 513 (or port 501). For example, the diameter of the inner portion of the front opening 211 is larger than the diameter of the inner portion of the front element inner opening 513. In at least one embodiment, the front element inner surface 522 has a constant diameter. In certain embodiments, the diameter of the front element outer surface 532 has a constant diameter. In various embodiments, the front element inner surface 522 employs a combination of constant and / or tapered dimensions. In one or more embodiments, the leading element outer surface 532 is substantially similar to the leading element inner surface 522 and has any of the dimensions described herein. In various embodiments, the leading element outer surface 532 does not have the same dimensions as the leading element inner surface 522. With respect to the above description, it is understood that the rear hollow element 202 and all of its subcomponents can have similar dimensions and / or similar structural features as the leading hollow element 201 (e.g., tapered inner and / or outer surfaces, constant inner and / or outer surfaces, combinations of tapered and constant surfaces on both). In various embodiments, the rear element outer surface 531 is gradually tapered to allow easier insertion of the catheter tube 101 and compatibility with various diameters of the catheter tube 101. In certain embodiments, the core opening 512 represents a transition region from a gradually increasing inner diameter to a constant inner diameter. In some embodiments, the tapered inner diameter does not significantly affect the hydrostatic pressure measurement during use. In various embodiments, the mating end opening 511 can have the same diameter as the inner diameter 411 A. In some embodiments, the inner diameter can be constant throughout the rear hollow element.

[0066] The front element inner opening 513, the front element inner surface 522, and the front opening 211 may have the same diameter as the inner diameter 412B. The front element outer surface 532 may have the same diameter as the front hollow element diameter 315A. In various embodiments, the mating end 111 has an outer surface 502 that is affixed or otherwise connected to the front hollow element 201. In certain embodiments, the front hollow element 201 is affixed to the outer surface 502 of the mating end 111 using adhesives, heat, chemical welding, and / or any suitable affixing process.

[0067] 6, a system architecture 600 of the bladder fullness detection system 200 according to one embodiment of the present disclosure is shown. In various embodiments, the system architecture 600 includes a computing environment 602, a measurement device 606, and a client device 608, which communicate with each other via a network 604. The network 604 may include, for example, the Internet, an intranet, an extranet, a wide area network (WAN), a local area network (LAN), a wired network, a wireless network, or other suitable network, or any combination of two or more such networks. For example, such networks may include a satellite network, a cable network, an Ethernet network, a Bluetooth network, a Wi-Fi network, an NFC network, and other types of networks.

[0068] In various embodiments, the computing environment 602 includes, for example, a server computer or any other system that provides computing power. In one embodiment, the computing environment 602 employs two or more computing devices that may be arranged, for example, in one or more server or computer banks, or other configurations. Such computing devices may be located in a single facility or distributed across many different geographic locations. For example, the computing environment 602 may include one or more computing devices that may together comprise host computing resources, grid computing resources, and / or any other distributed computing configuration. In certain embodiments, the computing environment 602 may correspond to elastic computing resources, where the capacity of allocated processing, network, storage, or other computing-related resources may change over time.

[0069] Various applications and / or other functions may be executed in the computing environment 602 according to various embodiments. In some embodiments, various data is stored in a data store 612 accessible to the computing environment 602. The data store 612 may represent one or more of multiple data stores 612 as may be understood. Data stored in the data store 612 may be associated with the operation of the various applications and / or functional entities described below, for example.

[0070] Components executing on the computing environment 602 include, for example, the list of applications, as well as other applications, services, processes, systems, engines, or functions described in further detail herein. In some embodiments, the management services 614 include a data management console 640 and a data processing console 642. In at least one embodiment, the data management console 640 distributes data to the data stores 612, the measurement devices 606, the client devices 608, and / or any other devices that request data for a particular function. In various embodiments, the data processing console 642 manages data processing for the system of the present disclosure.

[0071] According to an embodiment of the present disclosure, the data processing console 642 processes the data collected by the computing environment 602. In certain embodiments, the data processing console 642 receives recorded data related to an individual's bladder dynamics and emptying patterns to provide improved diagnosis and treatment monitoring to the medical professional. For example, the data processing console 642 may generate and send to the medical professional a statistical analysis report of the patient's bladder emptying patterns. In one or more embodiments, the data processing console 642 removes certain artifacts by filtering the data to its relevant variables. An artifact may be defined as an inconsistency in the data. For example, the processing console 642 may set a low pass filter and / or a high pass filter to remove noise and various other errors in the data. In some embodiments, the data processing console 642 performs various averaging methods on the data collected by the measurement device 606. For example, the data processing system 642 may calculate a moving average of the bladder pressure data to determine historical or periodic trends. In at least one embodiment, the data processing console 642 performs machine learning methods to create a predictive model of the user's bladder habits. For example, the data processing console 642 uses machine learning techniques to determine the likelihood that an individual will use the toilet after a rehabilitation session.

[0072] The data store 612 of the computing environment 602 may include user data 632, health data 634, device data 636, managed device data 635, and / or any other data store associated with the system. In some embodiments, the data store 612 is local to all components of the system architecture 600. In various embodiments, the data store 612 is stored remotely and accessible via the network 604. In one or more embodiments, the data store 612 is remotely accessible via the network 604.

[0073] In various embodiments, user data 632 includes all data related to a user. In particular embodiments, user data 632 includes name, age, date of birth, caregiver information, emergency contact information, home address, email, password, and / or any other relevant data for a user. In at least one embodiment, user data 632 serves as a heading for a list of related data, and all information related to a user references that particular user data 632. For example, device data 636 or a particular user connects to the user data 632 for a user.

[0074] In some embodiments, health data 634 includes all health-related information for a particular user. Health data 634 may include, but is not limited to, bladder threshold data, medical history, medical data, size, weight, and health care provider information. In various embodiments, health data 634 stores data related to an individual's bladder threshold. In some embodiments, client device 608 requests and receives bladder threshold data from a user or its corresponding medical professional. In one or more embodiments, data processing console 642 measures bladder fullness against the individual's bladder threshold data.

[0075] In at least one embodiment, device data 636 includes all data transmitted, collected, generated, or stored on the measurement device 606 and / or client device 608. Device data 636 may include, but is not limited to, system health data, system diagnostics, hydrostatic pressure data, and bladder health data.

[0076] In some embodiments, the measuring device 606 records and processes measured data from the bladder fullness detection system 200. In various embodiments, the measuring device 606 is housed within the measuring components housing 203 (see FIG. 2). In certain embodiments, the measuring device 606 includes a data store 616, a measurement module 618, a data distribution module 620, and a transducer 622. In various embodiments, the measuring device 606 is rechargeable, either wirelessly or by wire. In an alternative embodiment, the measuring device 606 is disposable and has a finite battery life.

[0077] In some embodiments, data store 616 of measurement device 606 stores and maintains certain data for processing and distribution. In various embodiments, data store 616 and data store 612 are substantially similar and share the same information. In some embodiments, data store 612 and data store 616 maintain separate data. In at least one embodiment, data store 612 includes, but is not limited to, script data 644 and measurement data 646.

[0078] In various embodiments, the script data 644 includes all programs used to power and function the measurement device 606. In certain embodiments, the script data 644 includes calculation scripts, data acquisition scripts, data transmission scripts, power sequence scripts, and / or any other code used to maintain the functionality of the measurement device 606.

[0079] In certain embodiments, the measurement data 646 includes all measurement data from the measurement device 606. In one or more embodiments, the measurement data includes hydrostatic pressure data, bacterial data, pressure versus time data, and / or any other measurable data. In various embodiments, the data delivery module 620 accesses the measurement data 646 and shares the data over the network 604. For example, the data delivery module transmits bladder pressure data to the computing environment 602.

[0080] The measurement module 618 can measure and transmit measurement data to the data store 616. In certain embodiments, the measurement module 618 uses a measurement script to activate and control a particular transducer 622. For example, the measurement module 618 can execute a particular recording script to record bladder fullness data from 9 p.m. to 7 a.m. to monitor the user's bladder while sleeping. In some embodiments, the measurement module 618 can perform substantially similar operations as the data processing module 642.

[0081] The data distribution module 620 can perform data distribution among the components of the system architecture 600. In certain embodiments, the data distribution module 620 can transfer data from the measurement device 606 to the computing environment 602 and the client device 608. In various embodiments, the data distribution module 620 can transfer data internally to a particular location. For example, the data distribution module 620 can transfer data from the transducer 622 to the measurement module 618 and from the measurement module 618 to the data store 616.

[0082] In one or more embodiments, the transducer 622 measures variations in the physical environment and generates electrically readable output data based on these variations. The transducer may include, but is not limited to, a pressure sensor, a pH sensor, a bacterial sensor, a flow sensor, a conductance sensor, and a transmitter. For example, the pressure sensor records the pressure of the liquid in the user's bladder (although the pressure sensor is located outside the user's bladder in at least one embodiment). Continuing with this example, the pressure sensor records the information and stores the data in the data store 616. Continuing with this example, the data delivery module 620 uses a transmitter to communicate and transfer the recorded information to the client device 608 and / or the computing environment 602.

[0083] In certain embodiments, the processing and functionality of the computing environment 602 is similarly performed by the client device 608 and / or the measurement device 606. Repeated subcomponents of the computing environment 602 may also reside on the client device 608 and / or the measurement device 606. For example, the data processing console 642 or the data store 612 may reside on the measurement device 606 to perform operations such as filtering data, smoothing data, determining bladder fullness, or determining how the bladder fullness compares to a user's fullness threshold. In another example, the data processing console 642 may reside on the client device 608 and perform operations similar to those described herein. In one or more embodiments, the data management console 640 may reside anywhere the data processing console 642 resides to facilitate operations performed by the data processing console 642. In at least one embodiment, the data management console 640 may reside on the measurement device 606, on the client device 608, and / or elsewhere alone, such as at a remote location. In certain embodiments, data management console 640 may manage data and interface with data store 612 and data store 616. In one or more embodiments, data management console 640 is responsible for the transfer of data between data store 612 and data store 616.

[0084] Data store 612 and data store 616 may partially overlap, completely overlap, or may be mutually exclusive. In various embodiments, data stored in data store 612, data store 616, in the cloud, and / or in some other remote or local storage may be accessed, modified, transferred, or deleted by requests sent from management service 614 or data distribution module 620. In one or more embodiments, data may reside temporarily in measurement module 618 before being stored in data store 616, before being stored in data store 612, before being processed by data processing console 642, before being sent via data distribution module 620, or before being discarded.

[0085] The client device 608 can receive communications over the network 604 from the computing environment 602 or the measurement device 606. In some embodiments, the client device 608 includes any mobile computing device used to display notifications, change user preferences, and retrieve related information from the bladder fullness detection system 200. In various embodiments, the client device 608 is a smart watch, a mobile phone, a laptop, or any mobile computing system. In one or more embodiments, the client device 608 controls a screen, an input system, data delivery, and / or any standard function of a mobile computing system. In certain embodiments, the client device 608 receives notifications from the computing environment 602 and / or the measurement device 606. For example, the measurement device 606 sends a notification to the client device 608 that it is time to empty the user's bladder. Continuing with the example, the notification is displayed on the client device 608. In certain embodiments, the client device 608 performs similar functions as the computing environment 602. In various embodiments, the client device 608 can send information to the computing environment 602 and / or the measurement device 606. For example, the client device 608 may update personal information and transmit this data to the computing environment 602 .

[0086] As can be appreciated, the system may perform the functions described above (and elsewhere herein) at any location or more than one location. For example, the system may be configured to process all data or only a portion of data at the computing environment 602, the measurement device 606, or the client device 608.

[0087] 7A and 7B, an anatomical view of the bladder fullness detection system 200 inserted into the bladder is shown according to one embodiment of the present disclosure. In some embodiments, the small bladder 703A is empty and / or substantially empty. In certain embodiments, the large bladder 703B is full and / or substantially full. In various embodiments, the measurement device 606 calculates the pressure using the hydrostatic principle. In one or more embodiments, the hydrostatic principle is defined as a method for calculating the pressure at a given point by multiplying the density, gravity, and height of the column for a hydrostatic system. In some embodiments, the bladder expands with some elasticity when filled, increasing the vertical fluid level of urine. In at least one embodiment, when the individual's bladder is located above the end of the catheter, the increased fluid level generates an increase in hydrostatic pressure that is sensed by the measurement device 606. In various embodiments, the measurement device 606 includes a data processing step to separate bladder fullness from artifacts. In certain embodiments, artifacts include, but are not limited to, bladder spasms and pressure changes in other body compartments, such as intra-abdominal or rectal pressure. In at least one embodiment, the measurement device 606 approximates the actual "fullness" of the bladder based on adjustments caused by certain artifacts.

[0088] In certain embodiments, the small bladder 703A is empty or nearly empty and serves as a baseline state for bladder fullness measurements. In at least one embodiment, the large bladder 703B is full or ready to void as defined by a medical professional and serves as a baseline state for threshold comparison. In one or more embodiments, the small bladder 703A and the large bladder 703B are the same bladder but in different states of fullness. In some embodiments, the small bladder 703A is nearly empty because the catheter eyelet is located above the catheter balloon 103. In various embodiments, having the catheter eyelet above the catheter balloon 103 creates a small pocket where urine can accumulate and remain when the bladder empties. As the bladder fills, urine can accumulate and begin to fill the catheter tube 101. In at least one embodiment, the bladder fullness detection system 200 can measure the initial urine height 702A by subtracting the known catheter tube 101 length from the measured total pressure column height. In various embodiments, the smaller bladder 703A expands as more urine is produced. The bladder fullness detection system may continually measure the hydrostatic column height. In one or more embodiments, the measured bladder fullness may result in a larger urine height 702B in the larger bladder 703B, indicating that the bladder has reached a fullness threshold 701B. The measurement device 606 and / or computing environment 602 may notify the client device 608 when the fullness threshold 701B is filled, stating to empty the user's bladder. In certain embodiments, the measurement device 608 may send a notification based on the percentage of the fullness threshold 701B that has been reached. For example, the measurement device 606 and / or computing environment 602 may notify the client device that the user's bladder has filled 75% of the fullness threshold 701B. In some embodiments, the percentage may be displayed by the client device 608 at all times, as shown in FIG. 13.

[0089] 8, a flow chart of a method 800 according to one embodiment of the present disclosure is shown. In certain embodiments, referring to steps 802-806, a bladder manager (e.g., a user, a caregiver, a medical team, or a combination of these persons) initiates the method 800. In certain embodiments, in step 802, the bladder manager introduces a urinary catheter into the user and secures the catheter in place. In various embodiments, in steps 804 and 806, the bladder manager connects the bladder fullness detection system 200 to the distal end of the catheter tube 101 and connects the catheter valve 102 to the front hollow element 201 of the bladder fullness detection system 200. In one or more embodiments, in steps 808 and 810, the bladder fullness detection system 200 collects and transmits bladder fullness information and compares the signal to a threshold. In certain embodiments, if the signal is less than the threshold, the method 800 returns to step 808. In one embodiment, if the signal is above the threshold in steps 816, 818, the measurement device 606 sends an alert to the client device 608 to empty the user's bladder. In some embodiments, in steps 820, 822, the measurement device 606 or the user can electronically or manually open the catheter valve 102, respectively. Once the user has emptied their bladder and closed the valve in step 822, the method 800 may return to step 808.

[0090] In at least one embodiment, during catheter introduction in step 802, the bladder manager inserts the catheter through the urethral meatus or stoma for urethral or suprapubic catheters, respectively. In various embodiments, once the catheter is inserted, the catheter balloon 103 is inflated using saline to anchor the catheter in place. Once the catheter is secured in place by the catheter balloon 103, method 800 may proceed to step 804.

[0091] In certain embodiments, step 804 begins with connecting the bladder fullness detection system 200 to the catheter tube 101 up to the mating end 111 . In step 806, a catheter accessory (eg, a catheter valve) connects to the first hollow element 201 of the bladder fullness detection system 200. In some embodiments, the catheter valve 102 is fixed in place.

[0092] In various embodiments, at step 808, the measuring device 606 collects raw signal data. In one or more embodiments, the signal may then be passed through an algorithm to filter artifacts to determine a "bladder fullness" metric. In certain embodiments, the measuring device 606 also includes the ability to predict future bladder fullness information.

[0093] In step 810, the measurement device 606 and / or computing environment 602 compares the bladder fullness measurement to a desired fullness threshold, according to one embodiment of the present disclosure. In various embodiments, the bladder fullness threshold is either pre-programmed for all users or customized for a particular user by a bladder manager.

[0094] In at least one embodiment, if the measured bladder fullness is less than the threshold value, the method returns to step 808. In certain embodiments, when the bladder fullness is greater than or equal to the threshold value, the method proceeds to step 816.

[0095] In step 816, the measurement device 606 sends an alert to the client device 608 to notify the user. In various embodiments, the bladder fullness detection system 200 sends the alert to the user via a light emitting diode or an audible alarm.

[0096] In step 818, the bladder manager receives notifications from the measurement device 606, according to some embodiments of the present disclosure. These notifications may be repeated if the alert in step 818 goes unacknowledged and the bladder fullness remains above the fullness threshold.

[0097] In step 820, the bladder manager obtains an appropriate container for urine disposal and, in accordance with one embodiment of the present disclosure, opens the catheter valve 102 to allow urine flow and empty the user's bladder. The bladder manager can then determine when the bladder is sufficiently emptied.

[0098] In step 822, the bladder manager may close the catheter valve to prevent further urine flow and allow the user to perform other activities. In some embodiments, method 800 proceeds from step 822 to step 808.

[0099] 9, a flow chart of a method 900 according to one embodiment of the present disclosure is shown. In a particular embodiment, the method 900 relates to the function of the measurement device 606 of the bladder fullness detection system 200.

[0100] According to one embodiment of the present disclosure, the measuring device 606 is powered up in step 902. In various embodiments, starting the measuring device 606 includes turning on the device and pairing the device with the client device 608. In some embodiments, once the measuring device 606 is powered up, the device will only be turned off by loss of power and other events.

[0101] In step 904, the measuring device 606 begins measuring relevant data according to one embodiment of the present disclosure. In some embodiments, the measuring device 606 measures a parameter such as hydrostatic pressure and applies a filtering or smoothing algorithm to the data. In one or more embodiments, the measuring device 606 uses a conversion algorithm to determine the fullness from the filtered or raw signal.

[0102] In step 906, the measuring device 606 determines whether the fullness threshold has been met, according to one embodiment of the present disclosure. In various embodiments, the measuring device 606 compares the fullness data to a bladder fullness threshold. In at least one embodiment, if the fullness threshold has not been met, the device returns to step 904. In some embodiments, if the fullness threshold has been met, the device enters step 908.

[0103] In step 908, the measurement device 606 sends a notification to the client device 608. In at least one embodiment, the notification is sent to the client device 608 over the network 604. After sending the notification, the device may wait for a set period of time to avoid sending notifications too frequently. In certain embodiments, the method 900 returns to step 904.

[0104] 10, a measurement device 606 pairing environment is shown according to one embodiment of the disclosure. In at least one embodiment, a client device 608 includes software that connects to the bladder fullness detection system 200 over a network 604. The software may include an illustration of a button on the bladder fullness detection system 200, specifically a pairing button that may cause the device to connect over a Bluetooth network. In one or more embodiments, a user interface shows the bladder fullness detection system 200 with a pairing button and a power button. In some embodiments, a user presses the pairing button to connect the bladder fullness detection system 200 to the client device 608.

[0105] 11, a possible setup screen for selecting or configuring notifications via a client device 608 is shown, according to one embodiment of the present disclosure. In some embodiments, the bladder fullness detection system 200 sends notifications and / or data regarding the fullness of the user's bladder to the client device 608. In at least one embodiment, these notifications are sent over the network 604 using software installed on the client device 608. In various embodiments, notifications are sent anywhere within a range of about 5-60 minutes prior to the predicted bladder voiding time. In certain embodiments, the user selects how early they would like to receive the first notification. In at least one embodiment, a notification is sent when complete bladder fullness is detected.

[0106] 12, a follow-up notification setting is shown according to one embodiment of the present disclosure. In at least one embodiment, the user selects the frequency of notifications regarding their bladder fullness. The device may stop sending notifications to the user once the user voids their bladder. Also, in certain embodiments, the device increases the notification frequency if the user's bladder is filled beyond a safe level indicated by a medical professional. In various embodiments, the user may select to receive additional notifications approximately every 1-30 minutes following the initial notification until the user empties the bladder. For example, the user specifies a 5 minute time interval for follow-up notifications in the event that the bladder has not been voided after the initial notification. Continuing with the example, after the client device 608 receives the initial notification and the bladder has not been voided, the measurement device 606 and / or computing environment 602 sends follow-up notifications to the client device 608 every 5 minutes. Continuing with the example, the measurement device 606 and / or computing environment 602 stop sending notifications once the bladder is voided.

[0107] 13, an exemplary dashboard is shown according to one embodiment of the present disclosure. In some embodiments, the client device 608 displays the approximate bladder fullness detected by the bladder fullness detection system 200. In certain embodiments, the client device 608 displays the next approximate urination time determined by the data processing console 642 in the computing environment 602. In at least one embodiment, the user interface includes elements that allow the user to change the notification timing and frequency. In at least one embodiment, the screen may further include elements that allow the user to access a list of past urination times and volumes.

[0108] 14, a notification is shown sent to a client device 608 according to one embodiment of the present disclosure. In certain embodiments, the notification includes information about when the next predicted urination event will occur. In at least one embodiment, the notification includes information indicating that the notification is a bladder fullness warning.

[0109] Further exemplary features: In certain embodiments, the bladder fullness detection system 200 manages the effects of overflow incontinence. In some embodiments, a typical urinary incontinence control system includes a urinary catheter that is inserted into the patient's urinary tract. The urinary catheter insert may reach the bladder on one end and connect to a drainage device on the other end. In various embodiments, the urinary incontinence control system is connected to the bladder fullness detection system 200 in-line between the catheter and the drainage device, where the drainage device is a catheter valve.

[0110] In at least one embodiment, feedback from the bladder fullness detection system 200 periodically sends a maximum bladder volume alert to the patient or caregiver. In an alternative embodiment, the bladder fullness detection system 200 is configured not to send a maximum bladder volume alert to the user and / or caregiver, but instead to open the connected urinary catheter valve 102 for drainage upon a signal from the bladder fullness detection system 200.

[0111] In some embodiments, the bladder fullness detection system 200 functions in a diagnostic or monitoring capacity for personal, medical, or research purposes. In various embodiments, when the bladder fullness detection system 200 functions as a diagnostic tool, it transmits raw signals or threshold occurrences to the patient or other facilitator, but the signals are not explicitly used for the relief of overflow incontinence symptoms. These data may be valuable for urodynamic studies (e.g., urodynamics, gait kinematics, voiding diaries).

[0112] In certain embodiments, a gyroscope or inertial measurement unit can be added to the bladder fullness detection system 200 to allow for broader data collection, such as measuring the angle or position of the catheter relative to the body to account for changes in measured pressure. In certain embodiments, the measured pressure changes are potentially due to posture changes between standing and sitting. The bladder fullness detection system 200 may be integrated with an internal valve to replace the catheter valve 102 or other catheter end accessories. In some embodiments, the bladder fullness detection system 200 is integrated with a catheter to replace a conventional catheter.

[0113] In some embodiments, the bladder fullness detection system 200 is integrated with the catheter system and catheter valve 102 such that it is a single device and the device can be reusable or disposable.

[0114] In certain embodiments, the bladder fullness detection system 200 may include a safety valve to prevent the bladder from reaching potentially destructive high pressures, or an indicator (e.g., an alarm or light) to notify the user in the event of a system failure.

[0115] The technical ideas contained in the present disclosure are described below. (Appendix 1) 1. A urinary catheter system comprising: a rear element for receiving a catheter, the rear element defining a rear opening having a first diameter, a mating end opening having a second diameter, and a core opening within a hollow interior, the core opening having the second diameter; the hollow interior extending from the rear opening to the joint end opening; The exterior and a mating end extending from the outer surface adjacent the mating end opening; the rear element having a front element defining a front opening and an inner opening and coupled to the rear element adjacent the inner opening, a front hollow interior between said front opening and said inner opening; a port between the front opening and the inner opening, the port being located at least 2 centimeters from the front opening for receiving a measurement housing component; a constant diameter between the inner opening and the port; said front element having The measurement housing component operably connected to the front element, one or more transducers for measuring hydrostatic pressure data within the front hollow interior; at least one transmitter for transmitting said hydrostatic pressure data to a computing system for calculating bladder fill level; the measurement housing component having A urinary catheter system comprising: (Appendix 2) The joint end has an outer joint end surface, 2. The urinary catheter system of claim 1, wherein the diameter of the joint end at the outer surface of the joint end is larger than the constant diameter of the front hollow interior. (Appendix 3) 3. The urinary catheter system of claim 2, wherein the measurement housing component extends through the outer wall of the front element to the front hollow interior via the port. (Appendix 4) 4. The urinary catheter system of claim 3, wherein the one or more transducers measure the hydrostatic pressure of urine within the front hollow interior. (Appendix 5) 5. The urinary catheter system of claim 4, wherein the bladder filling level is calculated by comparing the hydrostatic pressure data to a threshold value. (Appendix 6) 5. The urinary catheter system of claim 4, wherein the bladder filling level is calculated based on filtered hydrostatic pressure data. (Appendix 7) 5. The urinary catheter system of claim 4, wherein the computing system is configured to send an alert to a user device when it determines that the bladder fill level has reached a certain threshold. (Appendix 8) 2. The urinary catheter system of claim 1, wherein the constant diameter of the front hollow interior is greater than or equal to the second diameter of the joint end opening. (Appendix 9) 9. The urinary catheter system of claim 8, wherein the second diameter is larger than the first diameter. (Appendix 10) the second diameter is equal to the first diameter; 9. The urinary catheter system of claim 8, wherein an outer diameter of the rear element tapers toward the rear opening. (Appendix 11) 1. A method comprising: receiving, in the one or more processors, via a port through an outer wall of the catheter mounting component, hydrostatic pressure data derived from the one or more transducers associated with a volume of urine in the urinary catheter system; calculating a bladder fill level based on said hydrostatic pressure data; comparing said bladder fullness level to a predetermined threshold; sending an alert to a user device upon determining that the bladder fill level exceeds the predetermined threshold; A method for providing the above. (Appendix 12) 12. The method of claim 11, wherein the predetermined threshold is user-specific. (Appendix 13) 12. The method of claim 11, wherein calculating the bladder fill level includes filtering the hydrostatic pressure data. (Appendix 14) the hydrostatic pressure data includes a hydrostatic pressure parameter; 14. The method of claim 13, wherein calculating the bladder fill level includes comparing the hydrostatic pressure parameter to historical hydrostatic pressure data associated with a plurality of bladder fill levels. (Appendix 15) 14. The method of claim 13, wherein the one or more transducers are contained within a measurement housing component operably connected to the catheter mounting component via the port. (Appendix 16) the catheter mounting component comprises a rear element and a front element; the front element includes the port; 16. The method of claim 15, wherein the measurement housing component is operably connected to the front element via the port. (Appendix 17) 17. The method of claim 16, wherein the rear element and the front element are integrally formed. (Appendix 18) 18. The method of claim 17, wherein the rear element has at least two different inner diameters. (Appendix 19) 19. The method of claim 18, wherein the rear element is configured for at least partial insertion into a urinary catheter. (Appendix 20) 20. The method of claim 19, wherein the leading element is configured for operative connection to a catheter end accessory. [Conclusion] The embodiments have been chosen and described to explain the principles of the systems and methods in the claims and their practical application, so as to enable others skilled in the art to utilize the various embodiments with various modifications suited to the particular use contemplated. Alternative embodiments will be apparent to those skilled in the art to which the systems and methods pertain without departing from their spirit and scope. Thus, the scope of the claimed invention is defined by the claims rather than the foregoing description and exemplary embodiments described herein.

Claims

1. 1. A method comprising: receiving, in the one or more processors, via a port through an outer wall of the catheter mounting component, hydrostatic pressure data derived from the one or more transducers, the hydrostatic pressure data being associated with a volume of urine in the urinary catheter system; calculating a bladder fill level based on said hydrostatic pressure data; comparing said bladder fullness level to a predetermined threshold; sending an alert to a user device upon determining that the bladder fill level exceeds the predetermined threshold; Equipped with Calculating the bladder fill level includes filtering the hydrostatic pressure data; the hydrostatic pressure data includes a hydrostatic column height parameter; The method, wherein calculating the bladder fill level includes using the hydrostatic pressure column height to measure a urine height in the bladder associated with the bladder fill level.

2. The method of claim 1 , wherein the predetermined threshold is user specific.

3. The method of claim 1 , wherein the one or more transducers are contained within a measurement housing component operably connected to the catheter mounting component via the port.

4. the catheter mounting component comprises a rear element and a front element; the front element includes the port; The method of claim 3 , wherein the measurement housing component is operatively connected to the front element via the port.

5. The method of claim 4 , wherein said rear element and said front element are integrally formed.

6. The method of claim 5 , wherein the rear element has at least two different inner diameters.

7. The method of claim 6 , wherein the rear element is configured for at least partial insertion into a urinary catheter.

8. The method of claim 7 , wherein the leading element is configured for operative connection to a catheter end accessory.

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