Detection, tracking, and analysis of urinary events.

Abstract

To provide a system and method for processing and managing data generated from a uroflowmeter.SOLUTION: A method for generating a urination profile relating to a urinary event of a user includes: receiving by a processing element, a plurality of outputs from a fluid level sensor corresponding to a plurality of levels of fluid flowing through a urination device during a flow event; determining by the processing element, a start time and an end time of the fluid flow into the urination device during the flow event; analyzing the plurality of outputs of the fluid level sensor over a time interval defined by the start time and end time of the fluid flow to determine at least one of fluid flow rate data and cumulative flow rate data relating to the fluid flowing through the urination device; and storing the fluid flow rate data and the cumulative flow rate data in a memory.SELECTED DRAWING: Figure 4

Description

Technical Field

[0001] (Cross - Reference to Related Applications) This application claims priority from U.S. Provisional Patent Application No. 62 / 679,582, filed on June 1, 2018, entitled "UROFLOWMETER", the entire content of which is incorporated herein by reference for any purpose.

[0002] This application relates to U.S. Patent Application No. _____ (Attorney Docket No. P275160.US.01), filed on March 8, 2019, entitled "TESTING DEVICE FOR A UROFLOMETER", and to _____, filed on March 8, 2019, entitled "UROFLOWMETER" (Attorney Docket No. P275159.US.02), the entire content of which is incorporated herein by reference for any purpose.

[0003] The technology described herein generally relates to systems and methods for processing and managing data generated from a uroflowmeter.

Background Art

[0004] Uroflowmeters are used to monitor and diagnose the health of a patient's urinary tract. A uroflowmeter measures data related to a urination event or the urine flow during urination. A healthcare provider can use the data to diagnose urinary tract obstructions and other conditions before treatment and to track the progress and effectiveness of treatment.

[0005] Traditionally, uroflowmeters have been bulky, expensive, and inportable devices kept in the doctor's office. These devices are inconvenient and cannot accurately record all aspects of a patient's urination. This is because patients are placed in unnatural situations and cannot remain in the doctor's office near the uroflowmeter for a predetermined period exceeding two to three hours, and because patients may alter their behavior to use the uroflowmeter, leading to inaccurate results.

[0006] Regarding conventional in-office uroflowmeters, patients may be asked to keep handwritten records or written logs of their fluid intake and urination information such as urgency, frequency, or volume, or to keep a voiding (or urine) diary detailing voiding events over a specified period. Patients can record urine volume by urinating into a voiding bowl placed above the toilet. However, the bowl is large and indivisible, making it inconvenient for patients to carry both the voiding bowl and the paper diary. Due to the lack of portability, urinations are often missed from the diary. In addition, there is often a delay between when patients finish urinating and when they write in their diary, resulting in incorrect or missing information. Ultimately, there may be delays in submitting the paper voiding diary to the office for transcription into an electronic form. Handwritten text may be illegible, or worse, all diaries may be lost. These drawbacks lead to delays in patient care and a decline in the quality of patient care. [Overview of the project]

[0007] This disclosure generally relates to a system and method for processing and managing data generated from a urine flow meter.

[0008] A method for generating a urinary flow profile relating to a user's flow event is disclosed. The method includes: having a processing element receive multiple outputs from a liquid level sensor corresponding to multiple liquid level levels of the liquid flowing through a urination device during a flow event; having the processing element determine the start and end times of the fluid flow entering the urination device during a flow event; analyzing the multiple outputs from the liquid level sensor over a time interval defined by the start and end times of the fluid flow to determine at least one of fluid flow data and accumulated volume data relating to the flow through the urination device; and storing the fluid flow data and accumulated flow volume data in memory.

[0009] A method for authenticating flow events detected by a urination device as corresponding to urine events is disclosed. The method involves authenticating flow events detected by a urination device as corresponding to urine events, and includes: receiving flow characteristics of the fluid flow through the urination device from a fluid sensor and a verification sensor during a flow event; determining that the flow event corresponds to a urine event; sending unanalyzed data regarding the urine event to a server; and outputting a urination profile corresponding to the flow event.

[0010] A method for generating a urine diary for presentation on a user device is disclosed. The method includes determining, by a processing element, that a urine event has occurred; accessing urination profile characteristics corresponding to the urine event, the urination profile characteristics being detected by a urination device communicating electronically with a server; receiving urination data entered by the user via the user device; determining a time slot for the diary corresponding to the urine event and the user's urination data; and associating the urination event with the urination profile characteristics to create a correlation between the urination data entered by the user and the urination profile characteristics.

[0011] A method for correlating a urination device with a patient is disclosed. The method includes: receiving patient data corresponding to a patient using a processing element; generating a patient identifier corresponding to the patient data using the processing element; generating a first device identifier corresponding to a first part of the urination device using the processing element; generating a second device identifier corresponding to a second part of the urination device using the processing element; associating the first part of the urination device with the second part of the urination device; generating a link between the patient identifier and the first device identifier using the processing element in order to associate the patient data with the urination device; and outputting a confirmation screen to a display using the processing element to confirm the link between the patient identifier and the device identifier.

[0012] A method for evaluating the effectiveness of urological treatment is disclosed. The method includes receiving pre-treatment voiding diary data corresponding to the patient's urinary history during a first time interval, the pre-treatment voiding diary data including voiding characteristics detected by a voiding device during voiding events by the patient during the first time interval; receiving a treatment plan prescribed to the patient by a healthcare provider; receiving post-treatment voiding diary data corresponding to the patient's urinary history during a second time interval, the post-treatment voiding diary data including voiding characteristics detected by a voiding device during voiding events by the patient during the second time interval; analyzing the pre-treatment and post-treatment voiding diary data using the processing element to determine the effectiveness of the treatment; and outputting an evaluation of the effectiveness to a display using the processing element.

[0013] A system for evaluating the urinary health status of a patient is disclosed. The system includes a handheld urination device comprising a flow sensor, a device processing element and a flow chamber, which receives urine from a patient and, via the device processing element, receives multiple outputs of a flow sensor corresponding to multiple fluid level levels of the fluid flowing through the handheld urination device during a flow event; a server communicating with the handheld urination device, which receives flow event data from the urination device, analyzes the flow event data via the server processing element to authenticate urination events, determines parameters associated with the authenticated urination event data, associates the parameters with a urination diary stored in memory, and outputs a report on the urinary health status; and a healthcare provider device communicating with the server, which receives the report on the urinary health status from the server.

[0014] A method for processing data from a uroflowmeter is disclosed. The method includes providing a uroflowmeter that communicates with a voiding diary system, detecting flow event data by the uroflowmeter, transmitting the flow event data to the voiding diary system, analyzing the flow events by the voiding diary system to determine voiding events, analyzing urine level and duration data to determine voiding characteristics, and generating a graphic output of uroflow, duration, urine volume and timestamp data to create a treatment plan. [Brief explanation of the drawing]

[0015] [Figure 1] This is a simplified schematic diagram of an information management system for a urination device. [Figure 2A] This is a perspective view of an example of a urination device. [Figure 2B] This is a partially disassembled perspective view of an example of a urinary apparatus. [Figure 2C] This is a cross-sectional view of an example of a urination device along line 2C-2C in Figure 2A. [Figure 2D] Figure 2C is a cross-sectional view of an example of a urination device along line 2D-2D. [Figure 2E]Fig. 2A of the urinary device of the first configuration is shown. [Figure 2F] Fig. 2A of the urinary device of the second configuration is shown. [Figure 2G] Fig. 2A of the urinary device of the third configuration is shown. [Figure 2H] It is a perspective view of another example of the urinary device. [Figure 2I] It is a partial exploded perspective view of an example of the urinary device of Fig. 2H. [Figure 2J] It is a cross-sectional view of an example of the urinary device along line 2J-2J of Fig. 2H. [Figure 2K] It is a partial exploded perspective view of an example of the urinary device. [Figure 2L] It is a cross-sectional view of an example of the urinary device along line 2L-2L of Fig. 2K. [Figure 2M] It is an exploded three-dimensional view of an alternative urine flow meter according to various examples of the present disclosure. [Figure 2N] It is a cross-sectional view of the urine flow meter of Fig. 2M along line 2N-2N according to various examples of the present disclosure. [Figure 2O] It is a partial three-dimensional exploded view of the urine flow meter of Fig. 2M according to various examples of the present disclosure, and illustrates a method of separating the flow chamber and the handle of the urine flow meter. [Figure 2P] It is a partial detailed perspective view of an example of the attachment of the flow chamber and the handle of the urine flow meter of Fig. 2M. [Figure 3A] It is a simplified block diagram of the electronic device in an example of the urinary device. [Figure 3B] It is a simplified block diagram of the electronic device in an example of the server. [Figure 4] It is a flowchart illustrating a method of acquiring flow event data by the urinary device of Fig. 2A. [Figure 5] It is a flowchart illustrating a method of authenticating the acquired flow event data as corresponding to urination. [Figure 6A] It is an example of a urinary flow profile authenticated using the method of Fig. 5. [Figure 6B]This is an example of a cumulative urination volume profile authenticated using the method shown in Figure 5. [Figure 7] This is a flowchart illustrating a method for determining the urination characteristics of detected urination. [Figure 8] This flowchart illustrates how to obtain urination diary information corresponding to detected urination. [Figure 9] This is a flowchart illustrating how to associate urination information with selected patients. [Figure 10] Figure 2A is a flowchart illustrating how to determine the effectiveness of treatment using the urination device. [Figure 11] An example of a report generated by the method shown in Figure 8 is illustrated. [Figure 12] The change in acceleration detected by the urination device in use is illustrated. [Figure 13] The positioning error detected by the urination device in use is illustrated. [Figure 14] To authenticate detected urination, the relationship between the acceleration change and positioning error of the urination device in use is illustrated. [Figure 15] Figure 2A is a flowchart illustrating the method for activating, using, and transferring data using the urination device. [Figure 16A] This is a flowchart illustrating some implementation forms of the method shown in Figure 8. [Figure 16B] This is a flowchart illustrating some implementation forms of the method shown in Figure 8. [Figure 16C] This is a flowchart illustrating some implementation forms of the method shown in Figure 8. [Figure 16D] This is a flowchart illustrating some implementation forms of the method shown in Figure 8. [Figure 16E] This is a flowchart illustrating some implementation forms of the method shown in Figure 8. [Figure 17A] This is a flowchart illustrating some implementation forms of the method shown in Figure 9. [Figure 17B] This is a flowchart illustrating some implementation forms of the method shown in Figure 9. [Figure 17C]This is a flowchart illustrating some implementation forms of the method shown in Figure 9. [Figure 17D] This is a flowchart illustrating some implementation forms of the method shown in Figure 9. [Figure 17E] This is a flowchart showing a specific implementation of the method in Figure 9. [Figure 18] Figure 1 is a schematic diagram illustrating an example implementation of a part of the information management system. [Figure 19] This is an example of a uroflowmetry report for a patient's urination events. [Figure 20] This is an example of a patient's voiding diary report, illustrating voiding data over consecutive days. [Figure 21] This is an example of a comparative report of patient urinary flow data over several months. [Figure 22] This is an example of a comparative report of patient voiding diary data over several months. [Modes for carrying out the invention]

[0016] This disclosure generally relates to a system and method for analyzing and managing data generated from a urine flow meter, and to a urination device for improving accuracy to support patient diagnosis and treatment. In one example, a urination device communicating with another electronic device (e.g., a user's smartphone, tablet computer, laptop, server, cloud network, etc.) is disclosed. The urination device includes position and flow sensors that detect urination data, such as flow rate and time metadata, in response to a urination event or usage event. Examples of sensors in the urination device include a buoyant float coupled to a displacement sensor, a temperature sensor, a conductivity sensor, an opacity sensor, a clock, or a timer. Subsequently, the urination data detected by the sensors is validated to determine whether it corresponds to a urination event or to another urine / non-urination event, such as the patient cleaning the urination device after use. This validation not only reduces data transfer within the system but also helps prevent inappropriate data from being stored in the patient's urination profile information, improves the accuracy of the recorded urination profile, and enhances the effectiveness of treatment.

[0017] In one example, the system compares sensor data to validity criteria to determine whether the data is related to a urination event or to some other type of event, such as rinsing the urination device. In a specific example, the system uses the data to determine whether the float is oriented correctly, for example, whether it is upside down, sideways, or in another direction inconsistent with urination. If the float's orientation matches a user cleaning the device rather than a user urinating into it (e.g., the float is sideways), the detected data, such as flow rate, may be discarded as it corresponds to an event other than urination.

[0018] As another example, the system may also use detected flow characteristics such as peak flow rate, flow duration, or total flow volume to determine whether the collected data corresponds to urination. Specifically, if the peak flow rate is too high, the flow duration is too long, or the flow volume is too large, the system may discard the data, determining that such data corresponds to another event or contains an error, or associate the data with an event that is not urination. In another example, the system may determine that the temperature of the fluid flowing through the urination device is within a range that is expected to correspond to urination. In this system, one or more sensors can be used to validate the data in order to authenticate the detected data as corresponding to a urination event. Using multiple sensors introduces redundancy into the system, which helps prevent the inadvertent discarding of actual urination data. On the other hand, reducing the number of sensors can improve the processing speed at which data can be validated. Therefore, the number and types of flow information used to validate flow events for a particular user can be changed as needed.

[0019] If the voiding data actually corresponds to a patient's urinary flow event, the system uses the detected flow information to determine the voided urine volume, average urine flow rate, maximum flow rate, voiding duration, voiding flow time, time to maximum urine flow, and other detected voiding profile characteristics. These voiding profile characteristics may be generated in real time or after a series of urinations have been collected. The voiding characteristics or voiding data may be transmitted to the patient's personal electronic device or another electronic device, directly from the voiding device (e.g., via Bluetooth®), or via a network, for example, from a cloud server to the user's device. Similarly, the voiding characteristics can be transmitted directly or indirectly to healthcare providers and / or third-party insurance companies to help determine treatment and payment. The urination profile characteristics can be automatically transferred to the user's device and / or to the devices of third parties or healthcare providers. Since the urination profile characteristics are acquired in real time each time the user urinates, the data is accurate and can be used more effectively to evaluate treatment.

[0020] In addition, this disclosure includes a method for creating a more complete and holistic voiding diary, which was not possible with conventional devices, by associating detected voiding characteristics with user behavior, fluid intake, urine input, etc. For example, an application or other program running on the user device may receive user input regarding the user's fluid intake, urine events, leakage, etc., and the user is provided with questions or other interfaces tailored to the detected voiding profile characteristics. A urine event is any event involving the flow of urine from the user's urinary tract. By using user input and voiding characteristics, the system can generate a user voiding profile for a selected period of use. Because there is dual input (user input and detected data), it is possible to determine a one-to-one correspondence between urination and user behavior, thereby improving the accuracy of diagnoses by healthcare providers.

[0021] In connection with this, urination device information and user information may be transmitted to the healthcare provider's device. For example, a urination device may be assigned by the healthcare provider to a specific patient or user. The urination device may also be given a device identifier corresponding to a patient identifier, and these two may be associated or linked together. The user then inputs information into their mobile device. The urination data collected by the urination device may be received, processed, and transmitted directly to the healthcare provider's device so that the healthcare provider can receive urination profile data associated with a specific patient, user intake data, etc. After the period of use, for example, after an observation or examination period, or when treatment is completed, the user may return the urination device to the healthcare provider. At this point, the healthcare provider may unassociate the current user with the device, remove the disposable parts of the urination device (discarding the disposable parts and cleaning / disinfecting the durable parts), recharge the device, and return the durable parts of the urination device to service for assignment or association with another user. Furthermore, unassociating the urination device 200 may include recharging the battery 272, erasing stored information, and / or testing the device for preparation. In another example, a healthcare provider's office may have one or more urination devices in a charging unit, which may be made available for the patient to use while in the healthcare provider's office. The charging unit may be connected to the urination devices either wirelessly or via a wire (e.g., Universal Serial Bus “USB”), and may transmit and receive data from the urination devices. The charging device may subsequently transmit the received data to a server for storage, processing, analysis and reporting, or, if desired, may analyze the data itself.

[0022] The urination devices and methods described herein may also be used to evaluate the effectiveness of treatment, subsequently to modify treatment, and to generate a settlement framework for insurance companies or other third parties. For example, the system may receive pre-treatment urination diary data of a user, including urination characteristics detected by the urination device and user input information, and compare the pre-treatment urination diary data with post-treatment urination diary data created after the user has completed a predetermined treatment plan. By subsequently comparing these results with urination characteristics, experienced professionals can help determine the effectiveness of treatment and thresholds (e.g., time to maximum urine flow, number of urination events) that can be used to score and rank the effectiveness of various treatment plans. This scoring can be used to provide feedback to healthcare providers based on effectiveness, generate improved treatment plans, and provide payment plans. In addition, if a treatment plan is not effective for a particular patient, the healthcare provider or insurance company may use the pre-treatment and post-treatment urination diary data to determine the need to prescribe a different treatment plan for those patients.

[0023] Referring to Figure 1, a system 100 is disclosed for analyzing and managing data generated from a urine flow meter to support patient diagnosis and treatment and improve accuracy. The system may include a network 102, one or more urination devices 200 for measuring data relating to urination events or urine events, a user mobile device 108, a healthcare provider device 109, a reporting device 110, a charging station 114, and / or a third-party device 103. Any combination of the urination devices 200, the user mobile device 108, the healthcare provider device 109, the reporting device 110, the charging station 114, and / or the third-party device 103 can communicate electronically with each other via the network 102, or optionally directly (e.g., via a wired connection). The urination device 200 may communicate directly with the server 112 via the network 102. For example, the user mobile device 108 may communicate with the network 102 and / or the urination device 200 via the network 102, or directly without using the network 102. The urination device 200 may communicate directly with the charging station 114.

[0024] In one way the system is used, a healthcare provider, such as a physician, nurse, or other assistant, associates a handheld urination device 200 with a patient whose urinary tract health is being investigated. The patient can request treatment, receive treatment, or evaluate changes in their urinary tract health after treatment. The patient releases urine from their bladder into or onto the handheld urination device 200 (i.e., urinates). The urination device 200 collects data on various characteristics of the flow event as the liquid flows through the device, such as liquid level, flow rate, and cumulative volume. The urination device 200 then determines whether the flow event is urination and authenticates this data as urination data. If the flow event does not match a urination event, for example, if it is determined to match a rinsing event, or if the movement or other characteristics of the flow event are deemed to be unhelpful data, the urination device 200 discards the detected flow data. The urination device 200 can first perform a verification process of whether or not urination has occurred, and can discard invalid or useless data, so that only actual data for analysis can be stored, thus limiting the memory capacity of the device 200.

[0025] If the urination device 200 authenticates flow event data as potentially representing a urination event, the urination device 200 transmits the collected, unanalyzed data to the server 112 via a network 102, such as a cellular telephone network. The server processing element 152 then analyzes this potentially urination event data, verifies whether the data is related to a urination event, and subsequently determines various characteristics of urination, such as peak flow rate, urination volume, mean urine flow rate, time to reach maximum urine flow, flow time, urination time, or other desired characteristics. The server processing element 152 may be associated with the server 112, the healthcare provider device 109, the reporting device 110, the third-party device 103, the user mobile device 108, or another device. The server 112 may then record the urination profile characteristics in the patient's urination diary or urine event record. Alternatively, the patient may keep a urination diary by entering information into a user device hosting a diary application. Specifically, the urination diary may reside on a user mobile device 108, such as a mobile phone, but the urination diary may also be recorded manually. Server 112 may combine the data from the urination device 200 with user input data, as well as any other reports or surveys entered by the healthcare provider, insurance company, caregiver, or patient. The healthcare provider may then access the combined data to manage and monitor the patient's urinary health. When the patient has completed the urinary health survey, the urination device 200 may be returned to the healthcare provider for whole or partially reuse and for association with a new user.

[0026] In an example where a server processing element 152 analyzes urination data, the device processing element 252 of the urination device 200 can be manufactured more cheaply (and possibly disposable) and have more modest power requirements. This extends battery life compared to an example where the urination device analyzes data onboard. Furthermore, the server processing element(s) 152 is generally more powerful than an onboard microprocessor and is therefore capable of providing more robust analysis than the device processing element 252 within the urination device 200, allowing for faster data analysis. One or more servers 112 (e.g., a distributed cloud network or cloud computing) can process data from multiple urination devices 200, potentially further reducing costs. In addition, the server 112 can be more easily updated with new software and hardware compared to attempts to push updates to numerous urination devices 200 located in various locations, such as people's homes or doctors' offices. Furthermore, utilizing server 112 for analysis can support scalability, allowing system operators to purchase server time or processing power on virtual servers when deemed necessary due to increased demand, and to scale down the servers during other times of lower demand. Virtual servers 112 may be used instead of, or in addition to, physical servers 112. Security is crucial when handling patient medical data, so having server 112 analyze urination data is advantageous because, compared to numerous urination devices 200, server 112 offers more robust security and can keep several servers 112 safe.

[0027] Network 102 may be any system in which two or more processing elements communicate with each other. For example, Network 102 may be a private cellular telephone network, a local area network, radio transmission, a public network, or the Internet. Communication may occur on Network 102 by any suitable means, such as wired, wireless, or optical means. For example, Network 102 may include communication via Ethernet®, Wi-Fi®, Bluetooth®, near-field communication, wireless auto-identification, infrared, and other communication components such as Universal Serial Bus ("USB") cables or receptacles, or similar physical connections using conductive wires or fiber optic cables. It will be understood that Network 102 may have multiple networks. The urination device 200 may communicate directly with Network 102. For example, the urination device 200 may communicate via a cellular telephone network. Alternatively, the urination device may communicate with the user mobile device 108 via Bluetooth®, and the user mobile device 108 may then communicate with a server via the Internet.

[0028] The user mobile device 108 may be substantially any type of electronic or computer device and may be connected to one or more computer networks 102. For example, the user mobile device 108 may be a smartphone, tablet, laptop, or other portable computing device. The connection between the user mobile device 108 and the computer network 102 may be continuous or intermittent.

[0029] The healthcare provider device 109 may be substantially any type of electronic or computer device used by the healthcare provider in conjunction with the urination device 200. In one example, the healthcare provider device 109 may be a smartphone, tablet, or other portable computer. In another example, the healthcare provider device 109 may be a desktop computer, laptop, or server.

[0030] The reporting device 110 may be similar to the healthcare provider device 109, but is used in conjunction with the urination device 200 by the insurer. In one example, the reporting device 110 may be a smartphone, tablet, or portable computer. In another example, the reporting device 110 may be a desktop computer, laptop, or server.

[0031] The third-party device 103 is similar to the healthcare provider device 109 and / or reporting device 110 and is typically associated with a party other than the patient or healthcare provider, such as people or groups involved in the care of the user of the urination device 200. For example, the third party may be a caregiver, such as a family member, who is not a healthcare professional. In one example, the third-party device 103 may be a smartphone, tablet, or other portable computer. In another example, the third-party device 103 may be a desktop computer, laptop, or server.

[0032] The charging station 114 houses and charges the urination device 200 so that it is charged and ready for use. The charging station 114 charges the urination device by, for example, by using the induction coils of the charging station 114 and the urination device 200 in cooperation, or by interacting with the urination device 200 via a wired connection. The charging station 114 also interacts with the urination device 200 by analyzing and / or transmitting high-frequency data between the urination device 200 and the charging station 114. The transmitted data includes information about a specific urination device 200, such as a device identifier, device status, patient-related information, and battery charge status. The transmitted data may also include other information, such as patient flow data or urination data, and the transmitted data can be transmitted bidirectionally between the charging station 114 and the urination device 200. The transmitted data may further include software or firmware updates for the device processing element 252 of the urination device 200, which are stored in the memory 254. In various examples, high-frequency data is transmitted via Near Field Communication ("NFC"), Wi-Fi®, Bluetooth®, cellular telephone network technology, or other wireless technologies.

[0033] The urination device 200 acquires data corresponding to the user's urine flow events or urination events and determines urination data corresponding to these events. In one example, the urination device 200 is handheld, and the user can hold the urination device 200 over a toilet or other container when urinating and taking in the urine flow. In another example, the urination device 200 may be attached to a toilet seat to receive the user's urine in the event of a urination event. The urination device 200 may have one or more openings of a predetermined size and shape from which urine can flow out of the urination device 200. Examples of the urination device 200 are disclosed in U.S. Patent Application No. 62 / 679,582, filed June 1, 2018, and titled “UROFLOWMETER”, and U.S. Patent Application No. 29 / 649,761, filed June 1, 2018, and titled “UROFLOWMETER”.

[0034] In various examples, data can be transmitted in multiple ways between the urination device 200, the server 112, and associated user devices (e.g., user mobile device 108, healthcare provider device 109, reporting device 110, third-party device 103, etc.). Figure 18 illustrates a specific implementation of the information management system 100 of Figure 1. The implementation includes one or more patients who may have a user mobile device 108. The implementation includes two networks 102a and 102b. Network 102a is the internet or cloud. Network 102b is a private cellular provider network. There are two servers 112a and 112b. Server 112a is a server provided by the implementer of the information management system 100. Server 112a can run a web application for the implementer's staff to manage clinic settings, inventory, and distribution functions. Server 112b can run a web application for the implementer's staff to manage SIM card allocation, billing, system access, and higher-level corporate management functions. There is a USB-based radio frequency identification ("RFID") reader 118. There is a web portal 120 with multiple custom user interfaces ("UIs"). There are multiple service application program interfaces ("APIs") 116. In its simplest form, an API is a set of computer executable instructions that enable two devices or two software programs to communicate with each other. There are multiple urination devices 200. Some of the urination devices 200 are located in an inductive charging station 114 when not in use. In this implementation, there are two healthcare provider devices 109a and 109b. Healthcare provider device 109a is a tablet computer accessible to clinicians such as physicians and clinical assistants, and / or administrative staff. Healthcare provider device 109b is a desktop personal computer accessible to clinicians and / or clinical assistants.

[0035] The urination device 200 communicates with a service API 116 via the cellular network 102b. The service API 116 enables communication between the cloud 102a and the urination device 200. The urination device 200 also communicates with the healthcare provider device 109a via NFC. The NFC data transmitted between the urination device 200 and the healthcare provider device 109a may include the same data as that transmitted between the charging station 114 and the urination device 200. The healthcare provider device 109a may use NFC to associate or disassociate the urination device 200 with a patient. The healthcare provider device 109a communicates with the service API 116 via the cellular network 102b. The healthcare provider device 109a may communicate with the urination device 200 using cellular communication instead of NFC, or in addition to NFC. The healthcare provider device 109a may also include an RFID communication device to communicate with the urination device 200. Server 112a provides services to a web portal 120 with multiple custom UIs. Server 112a communicates with a USB-based RFID reader 118 that can add new urination devices 200, manage existing urination devices 200, and / or remove damaged, lost, used, or expired urination devices 200 from the information management system 100. Healthcare provider device 109a communicates with the web portal UI 120 via the cellular network 102b and communicates with server 112a and other devices in the information management system 100. Healthcare provider device 109b communicates with the web portal UI 120 via wired or wireless communication technologies such as Wi-Fi®, or Ethernet®, and communicates with server 112a and other devices in the information management system 100. User mobile device 108 communicates with the service API 116 via the cellular network 102b or via Wi-Fi®. The user mobile device 108 also communicates with the web portal 120. The server 112b communicates with the cloud 102a and the cellular network 102b, and provides a user interface between networks 102a and 102b.

[0036] In the exemplary use case of the information management system 100 implementation shown in Figure 18, the patient is requesting treatment from a clinician. The clinician or staff associates the urination device 200 with the patient using the healthcare provider device 109a or 109b. The patient uses the urination device 200 to record flow information from urination events. The urination device 200 transmits the flow data to the server 112a via the service API 116 for analysis and verification. The patient records information related to urination events by accessing a custom UI supplied by the web portal 120 or by using a user mobile device 108 with a custom application installed on the user mobile device 108. The server 112a combines the data from the user mobile device 108 with the data from the urination device 200 to create a comprehensive urination diary that can be accessed by the clinician via the healthcare provider device 109a or 109b and used to diagnose, treat, and evaluate the patient's condition.

[0037] Figure 2A shows a perspective view of an exemplary urination device 200. Figure 2B shows an exploded stereoscopic view of the urination device 200 of Figure 2A. The urination device 200 includes a flow chamber 204 for temporarily collecting and measuring the flow of urine or other fluid while the user is urinating. The flow chamber 204 includes an inlet 204a and an outlet 204b. The flow chamber 204 includes a funnel 206 which, if desired, creates a smooth urine flow into the flow chamber. The funnel 206 may define a contour that directs or guides the urine flow into the flow chamber 204. The contour of the funnel 206 can facilitate the reduction of turbulence of urine within the flow chamber 204. This can create a smooth or steady urine flow for the patient within the flow chamber 204. In some cases, the funnel 206 can form a steady laminar flow of urine. The funnel 206 may include a mechanism for aligning or positioning the anatomical structure of a male patient with respect to the urination device 200 in order to facilitate directing or guiding the male patient's urine to the inlet 204a of the flow chamber 204. The inlet 204a receives the user's urine during use, and the outlet 204b allows the collected urine to be discharged from the urination device 200 to a toilet or other disposal site. The inlet 204a may be defined along the top of the urination device 200 to facilitate urine collection. The outlet 204b may be defined along the side of the urination device 200 (e.g., the front wall as shown in Figures 2A and 2B) to facilitate urine disposal and allow the user to easily direct and discharge the urine into a suitable container. The urination device 200 generally includes a handle 202 for the patient to grasp. The handle 202 extends rearward from the flow chamber 204 and may be elongated to provide an ergonomic grip for the patient's hand, and may also be relatively elongated. In some embodiments, a light-emitting diode ("LED") is incorporated into this extended handle. The LED may indicate the directional value of the urination device 200, corresponding to a target condition such as a target direction value.

[0038] The urination device 200 may include various sensors for detecting urination data corresponding to urination events. The urination device 200 may also include various types of sensors for measuring urine flow rate and urine volume. In many examples, the urination device 200 includes one or more flow sensors or liquid level sensors 262. One or more liquid level sensors 262 may be substantially any type of electronic device or multi-device capable of detecting the liquid level in the flow chamber 204 of the urination device 200. The liquid level sensors 262 may output an electrical or optical signal corresponding to the liquid level in the flow chamber 204. The output of the liquid level sensors 262 may correspond to the position of the liquid level sensors 262 during a time interval. The liquid level sensors 262 may include one or more image sensors or optical sensors (e.g., time-of-flight sensor systems), inductive sensors, magnetic sensors and / or other sensors. In various examples, the liquid level sensors 262 measure the liquid level in the flow chamber 204 using detection of the magnetic Hall effect. The liquid level sensor 262 may also include a magnetic displacement sensor 222, such as a rotating Hall effect sensor, which measures the rotation angle of a nearby magnet 226.

[0039] It should be noted that the displacement sensor 222 can measure either the linear or angular displacement of the float. In another example, the liquid level sensor 262 is an accelerometer attached to a flexible float. For example, as the float rises and falls in accordance with the liquid level, the accelerometer records the change in the position of the accelerometer, and therefore the change in the liquid level. In yet another example, the liquid level sensor 262 is a plurality of corresponding pairs of wetted electrodes placed at various positions within the flow chamber 204. As the fluid in the flow chamber 204 rises, the fluid bridges the corresponding pairs of electrodes, allowing current to flow between the electrodes, thereby enabling the detection of the liquid level. In yet another example, the liquid level sensor 262 is a plurality of temperature sensors, such as thermistors, thermocouples, or resistance temperature devices, placed at various positions within the flow chamber 204. As the fluid in the flow chamber 204 rises, temperature changes occur in the various temperature sensors, thereby enabling the detection of the liquid level. In yet another example, the liquid level sensor 262 is a resistive strip that undergoes a change in electrical resistance when exposed to a conductive fluid such as urine. In another example, the liquid level sensor 262 is a photodetector, such as a camera, or a light emitter and light receiver, that measures the liquid level in the flow chamber 204 by comparing it to a scale line in the flow chamber 204 (for example, a line indicating the volume of fluid at a given point). In yet another example, the liquid level sensor 262 is a light emitter and light receiver that measures changes in optical transmission force through an optical fiber element when the optical fiber element is subjected to fluctuations in the liquid level in the flow chamber 204. In yet another example, the liquid level sensor 262 is a strain gauge, such as a Wheatstone bridge, coupled to a buoyant element. As the float moves, the strain gauge measures the strain on the float, for example, corresponding to various levels of fluid in the flow chamber 204.

[0040] The urination device 200 may have one or more verification sensors 260, the device processing element 252 of the urination device 200 capable of analyzing one or more authentication characteristics and verifying whether the collected data corresponds to an authenticated urination event. These verification sensors 260 may determine the authentication characteristics of the urination device 200 and / or the authentication characteristics of the environment of the urination device 200, and subsequently compare this with representative urination authentication characteristics and / or urination environment to determine whether the event is a urination event and whether the data is usable urination (e.g., whether it is too noisy or prone to errors). In one example, the verification sensors 260 include one or more direction sensors. In one example, the direction sensor is an accelerometer. In one example, the direction sensor is a gyroscope. In one example, the verification sensors 260 detect user gripping. In one example, the gripping sensor is a capacitive or resistive sensor having an output corresponding to user gripping. In another example, the verification sensor 260 is a button, switch, etc., that indicates that the user has activated the device and that the urination device 200 is about to receive urine. In yet another example, the verification sensor 260 is a proximity sensor that detects the proximity of the urination device 200 to the user's hand, body, or genitals and indicates to the urination device 200 that it is about to receive urine.

[0041] The liquid level sensor 262 measures the liquid level in the flow chamber 204. In one example, the liquid level sensor 262 includes a buoyant float 230 coupled to a displacement sensor 222, and the displacement sensor 222 in combination with such float 230 can be used to measure the liquid level in the urination device 200, or changes to the liquid level, over time. The displacement sensor 222 is coupled to the flow chamber 204 and liquid-sealed from the annular space 216. For example, the flow chamber 204 defines a housing 224 to which the displacement sensor 222 is sealed. The housing 224 liquid-seals the displacement sensor 222 from the fluid in the flow chamber 204, while the displacement sensor 222 is able to detect the liquid level in the flow chamber 204.

[0042] As illustrated in Figures 2A to 2D, and especially in Figures 2E to 2G, for example, as the liquid level of urine or other fluid in the flow chamber 204 increases, the float 230 rises within the flow chamber 204. Similarly, as the liquid level of urine in the flow chamber 204 decreases, the float 230 descends within the flow chamber 204. As the float 230 rises and falls, the magnet 226 rotates around the pivot axis 232 via the first and second arms 234a, 234b in correspondence with the displacement sensor 222. The displacement sensor 222 detects the angular position Φ of the magnet 226 using the magnetic flux of the magnet 226, and the liquid level in the flow chamber 204 can be determined from the angular position data of the magnet 226 by using a lookup table that correlates the angular position of the magnet 226 with the position of the float 230, and therefore the liquid level in the flow chamber 204.

[0043] Figures 2E to 2G illustrate the previously mentioned point, using the reference direction A s A displacement sensor 222 having a reference direction A m The diagram shows a magnet 226 having the following characteristics. For illustrative purposes, the angular position Φ of the magnet 226 is relative to the reference direction A. s and reference direction A m It can be defined as the angle enclosed by the curve. As the filling level of the flow chamber 204 rises, the magnet 226 rotates, and therefore, the reference direction A m Reference direction A s It is shown that the magnet 226 moves relative to this, and as a result, its angular position Φ changes.

[0044] Figures 2E to 2G show a displacement sensor 222 that detects different magnetic properties T for different angular positions of the magnet 226. For example, in the first configuration of Figure 2E, the displacement sensor 222 can detect a magnetic property T1 that may correspond to the magnetic flux exhibited by the magnet 226 when positioned at angular position Φ1. Angular position Φ1 may correspond to the position of the float 230 at the bottom of the flow chamber 204, such as when the flow chamber 204 is empty.

[0045] Generally, as the flow chamber 204 is filled with fluid (e.g., urine) from the flow path F1, the float 230 rises, causing the magnet 226 to rotate, allowing the magnet 226 to exhibit different magnetic properties detectable by the displacement sensor 222. Referring to Figure 2F for illustration, the urination device 200 is shown in a second configuration in which the flow chamber 204 contains urine 201 at a filling level 203a. In Figure 2F, the float 230 is shown in a higher position than the float in Figure 2E, and this position coincides with the filling level 203a of urine 201. The position of the float 230 at the raised filling level 203a causes the magnet 226 to rotate to an angular position Φ2. At angular position Φ2, the magnet 226 may exhibit magnetic properties T2 detectable by the displacement sensor 222. In this regard, the displacement sensor 222 detects the magnetic property T2, which the urination device 200 (or server, or related system or device) may then use to determine that the filling level of the flow chamber 204 is the filling level 203a shown in Figure 2F.

[0046] Generally, as the flow chamber 204 continues to fill with fluid, such as from the flow path F1, the float 230 continues to rise, which in turn causes the magnet 226 to rotate further, allowing the magnet 226 to exhibit different magnetic properties detectable by the displacement sensor 222. Referring to Figure 2G for illustrative purposes, the urination device 200 is shown in a third configuration in which the flow chamber 204 contains urine 201 at a subsequent filling level 203b. In Figure 2G, the float 230 is shown in a higher position than the float in Figure 2F, and this position coincides with the subsequent filling level 203b of the urine 201. The raised position of the float 230 at the subsequent filling level 203b causes the magnet 226 to rotate to an angular position Φ3. At angular position Φ3, the magnet 226 may exhibit magnetic properties T3 detectable by the displacement sensor 222. In this regard, the displacement sensor 222 detects the magnetic property T3, which the urination device 200 (or related system or device) may then use to determine that the filling level of the flow chamber 204 is the subsequent filling level 203b shown in Figure 2G.

[0047] The patient's urine flow rate can be measured using liquid level information (for example, by calculating the change in liquid level based on a predetermined outflow rate from the flow chamber 204, such as the outflow rate of the flow along the flow path F2). The liquid level can also be converted to the total urine volume collected by the urination device 200, i.e., the total volume of urine excreted or urinated by the patient (for example, by integrating the flow curve over the total time the patient used it). In addition to the pitch and / or roll values, the liquid level detected by the verification sensor 260 is used as input to a multidimensional lookup table to determine the retained volume and outflow rate. For example, the calculation / processing may be (pitch, roll (optional), liquid level) → [lookup table] → (retained volume, outflow rate).

[0048] Figures 2H–2J illustrate another example of the urination device 1100, including an energy dissipation mechanism 1128. The energy dissipation mechanism 1128 is shown substantially located within the flow chamber 1104. At least a portion of the energy dissipation mechanism 1128 may be concealed by the funnel 1106, and at least another portion of the energy dissipation mechanism 1128 may be visible along or within the inlet 1104a. The energy dissipation mechanism 1128 can broadly define a physical obstruction or blockage to the urine flow entering the flow chamber 1104 through the inlet 1104a. The energy dissipation mechanism 1128 may have a size, shape and contour that dissipates energy from the urine flow, such as kinetic energy. Many shapes are possible, but in the example in Figures 2H–2J, the energy dissipation mechanism is shown as a group of elongated cylinders. These elongated cylinders may generally extend from the bottom of the flow chamber 1104 toward the inlet 1104a. While the elongated cylinders may generally be fixed to the bottom of the flow chamber 1104, near the inlet 1104a, each elongated cylinder may have a free end that allows for deformation, bending, vibration, etc. The elongated cylinders are separated from each other, thereby allowing flow between a group of cylinders. In some cases, the elongated cylinders may have a tapered or other contour that changes with the height of the cylinder.

[0049] The energy dissipation mechanism 1128 can facilitate the detection of urine level and urine flow. For example, the energy dissipation mechanism 1128 can help reduce turbulence in the flow chamber 1104, such as that which may be caused by the steady fluid volume and the fluid flow. In some cases, the energy dissipation mechanism 1128 can also help reduce the amount of fluid discharged through the inlet 1104a. For example, the energy dissipation mechanism 1128 can reduce the kinetic energy of the urine flow in a way that suppresses spillage flowing out of the urination device 1100 through the inlet 1104a, thereby facilitating the smooth and continuous operation of the float 1130 and its associated components.

[0050] Referring to Figures 2K to 2L, another urination device 1400 is shown. Figure 2K is an exploded view of the urination device 1400, and Figure 2L is a cross-sectional view of the urination device 1400 along line 2L-2L in Figure 2K.

[0051] As illustrated in Figures 2K to 2L, the urination device 1400 includes a handle 1402, a bowl or flow chamber 1404, and a funnel 1406. The funnel 1406 includes one or more funnel inlets that allow fluid to pass from the funnel 1406 to the flow chamber 1404. The funnel inlets may be of any preferred shape and number to allow fluid to flow smoothly from the funnel 1406 to the flow chamber 1404. The funnel inlets may be a single configuration for male patients or different configurations for female patients. In one example, the funnel 1406 has a first funnel inlet 1406b. In another example, the funnel 1406 includes one or more second inlets 1406c.

[0052] The urination device 1400 generally includes the same or similar components as the urination device 200 and the urination device 1100, and operates in the same or similar manner as the urination device 200 and the urination device 1100. Therefore, the description of the urination device 200 and / or the urination device 1100 can be applied to the urination device 1400. In this regard, the urination device 1400 shown in Figures 2K to 2L, which is substantially similar to the example of the urination device 1100 described above, includes a proximal part 1402a, a distal part 1402b, an upper shell 1403, an inlet 1404a, an outlet 1404b, a lower shell 1405, a handle groove 1409a, a handle projection 1409b, a flow chamber projection, a flow chamber groove 1410b, a sensor 1422, a sensor receiving mechanism 1423, an energy dissipation mechanism 1428, a magnet 1426, a float 1430, and a structural part. The structural member 1430a, buoyancy member 1430b, ventilation hole 1440, electronic equipment 1450, first printed circuit board 1452, second printed circuit board 1454, flexible connector 1456, RFID mechanism 1460, SIM mechanism 1462, battery 1464, antenna 1466, NFC mechanism 1467, proximity sensor 1468, charging coil 1470, vent disk 1472, and other electrical / mechanical components 1474 are further included, but for clarity, redundant descriptions are omitted here. The structural member 1430a may be configured to maintain accurate readings from the sensor 1422 during periods of high fluid flow.

[0053] Referring to Figures 2M to 2P, the urine flow meter 1700 is shown. Figure 2M is an exploded view of the urine flow meter 1700, and Figure 2N is a cross-sectional view of the urine flow meter 1700 along line 37-37 in Figure 2M. Figure 2O is a partial exploded view of the urine flow meter 1700 in Figure 2M. Figure 2P is a partial detail view of the connection mechanism between the flow chamber 1704 and the handle 1702 of the urine flow meter 1700.

[0054] As illustrated in Figures 2M to 2P, the urine flowmeter 1700 includes a handle 1702, a bowl or flow chamber 1704, and a funnel 1706. The funnel 1706 includes one or more funnel outlets that allow fluid to pass from the funnel 1706 to the flow chamber 1704. The funnel outlets may be of any preferred shape and number to allow fluid to flow smoothly from the funnel 1706 to the flow chamber 1704. The funnel outlets may be a single configuration for male patients or different configurations for female patients. In one example, the funnel 1706 has a first funnel outlet 1706b. In another example, the funnel 1706 includes one or more second outlets 1706c. In one example, the funnel includes five second outlets.

[0055] The urine flow meter 1700 generally contains the same or similar components as the urine flow meters 200, 1100, and 1400, and operates in the same or similar manner as the urine flow meters 200 and 1100. Therefore, the descriptions of the urine flow meter 200, urine flow meter 1100, and / or urine flow meter 1400 can be applied to the urine flow meter 1700. In this regard, the urine flow meter 1700 shown in Figures 2M-2P, which is substantially similar to the examples of urine flow meters 200, 1100, and 1400 described above, consists of a proximal part 1702a, a distal part 1702b, an upper shell 1703, an inlet 1704a, an outlet 1704b, a lower shell 1705, a handle groove 1709a, a handle projection 1709b, a flow chamber projection, a flow chamber groove 1710b, a sensor 1722, a sensor receiving mechanism 1723, an energy dissipation mechanism 1728, a magnet 1726, and a float 1730. The system further includes structural member 1730a, buoyancy member 1730b, ventilation hole 1740, electronic equipment 1750, first printed circuit board 1752, second printed circuit board 1754, flexible connector 1756, RFID mechanism 1760, SIM mechanism 1762, battery 1764, antenna 1766, NFC mechanism 1767, proximity sensor 1768, charging coil 1770, vent disk 1772, and other electrical / mechanical components 1774, but for clarity, redundant descriptions are omitted here. Structural member 1730a may be configured to maintain accurate readings from sensor 1722 during periods of high fluid flow.

[0056] Figure 2O illustrates the urination device of Figure 2M, in which the flow chamber 1704 of the urine flowmeter 1700 is detachably attached to the handle 1702, thereby allowing the flow chamber 1704 to be discarded after use by the patient. In various examples, the urine flowmeter 1700 does not include a disposable funnel. As illustrated in Figures 2O to 2P, the flow chamber 1704 may have one or more gripping mechanisms 1778a, 1778b that grip the cooperative mechanism of the handle 1702. In one example, the gripping mechanisms 1778a, 1778b are springs including a cantilever 1784 separated from the body of the flow chamber 1704 by a gap 1788. In this example, the gripping mechanisms 1778a, 1778b include a projection 1786. When the gripping mechanisms 1778a, 1778b are in the relaxed position, the projection 1786 grips the corresponding mechanism of the handle, preventing the user from separating the flow chamber 1704 from the handle 1702. The flow chamber 1704 and the handle 1702 can be separated using the key 1776. The key can be used by a medical professional but not by the user. The key 1776 may include a handle 1792 connected to a shaft 1790, a pivot recess 1782 defined at one end of the shaft 1790, and one or more decouplers 1780a, 1780b arranged radially around the pivot recess 1782. One or more decouplers 1780a, 1780b, in cooperation with one or more gripping mechanisms 1778a, 1778b, allow a healthcare worker to separate the flow chamber 1704 of the urine flow meter 1700 from the handle 1702. In one example, a healthcare worker inserts a key 1776 into the urine flow meter 1700 so that a pivot recess 1782 cooperates with a pin on the urine flow meter 1700. By rotating or twisting the key 1776, the healthcare worker presses one or more decouplers 1780a, 1780b against one or more gripping mechanisms 1778a, 1778b, flexing the cantilever 1784 and disengaging the projection 1786 from the handle 1702. Subsequently, the healthcare worker may slide the flow chamber 1704 away from the handle 1702. The healthcare worker may then discard the flow chamber 1704, or disinfect and dispose of it for reuse.The medical professional may then reprocess the handle 1702 for reuse, as previously stated. The key 1776 and associated mechanisms of the handle 1702 that prevent the user from detaching the handle 1702 from the flow chamber 1704 are shown for illustrative and illustrative purposes in Figures 2M to 2O with respect to an example of a urination device 1700. The key, and these or similar mechanisms, are equally applicable to and may be included in any urination device, including the urination devices 200, 1100, 1400 and / or 1700 disclosed herein.

[0057] Figure 3A is a simplified block diagram of further components incorporated into or coupled to the urination device 200. These components may be enclosed within the handle 202 or in other locations within the device housing. Referring to Figure 3A, the urination device 200 may include one or more device processing elements 252, one or more memory components 254, a power supply 256, an input / output (I / O) interface 258, one or more verification sensors 260, and one or more liquid level sensors 262. The device processing elements 252 may include a clock. The urination device 200 may also include other components typically found in computing systems, such as a communication interface and other sensors in particular. For example, the urination device 200 may include a cellular telephone network modem that can communicate directly over a cellular network. Each element of the urination device 200 may communicate with each of the other elements of the urination device 200 wirelessly or otherwise via one or more system buses 266. The urination device 200 can transfer data to various computing devices (e.g., user mobile device 108, healthcare provider device 109, reporting device 110, third-party device 103 and / or server 112).

[0058] At least some of the components or elements of the urination device 200 may be housed within the urination device 200. For example, one or more of the device processing element 252, memory component 254, power supply 256, input / output (I / O) interface 258, verification sensor 260, and liquid level sensor 262 may be located within or received within the urination device 200. For example, one or more of the device processing element 252, memory component 254, power supply 256, input / output (I / O) interface 258, liquid level sensor 262, and verification sensor 260 may be housed within or received within the handle 202, and the magnet 226 may be received within the flow chamber 204. The device processing element 252 may be associated with a printed circuit board 270, which may be received within the handle 202 of the urination device 200, for example, as shown in Figure 2C.

[0059] Another example of the urination device 1100 is illustrated in Figures 2H to 2J. The urination device 1100 may include electronic components 1150. While many different components may be used to implement the operation of the urination device as described herein, Figures 2I and 2J illustrate an example of the structure of components defining or associated with the electronic components 1150. Broadly speaking, the electronic components 1150 may include a first printed circuit board 1152 and a second printed circuit board 1154. The first printed circuit board 1152 and the second printed circuit board 1154 may be connected to each other by a flexible connector 1156. In the example of Figures 2I and 2J, the first printed circuit board 1152 may be located in the handle 1102 near the proximal portion 1102a, and the second printed circuit board 1154 may be located in the handle 1102 near the distal portion 1102b.

[0060] This dual circuit board structure makes it easy to position components at different locations on the handle 1102 based on the desired function. For example, the first printed circuit board 1152 may be positioned away from the flow chamber 1104 and associated with battery operation, charging, etc., while the second circuit board 1154 may be positioned near the flow chamber 1104 and associated with the flow chamber 1104's sensors and operation. In the example in Figures 2H to 2J, the first printed circuit board 1152 and the second printed circuit board 1154 are shown as separate circuit boards connected by a flexible connector 1156, but other configurations are possible in other examples. For example, the first printed circuit board 1152 and the second printed circuit board 1154 may be part of a single circuit board, such as a hybrid rigid / flexible circuit assembly having rigid and flexible parts. This approach using a single component or assembly can improve reliability by reducing connections and / or reduce manufacturing costs.

[0061] In the examples of Figures 2H to 2J, the first printed circuit board 1152 may be associated with at least an RFID element 1160, a battery 1164, an antenna 1166, a proximity sensor 1168, a charging coil 1170, a vent disk 1172, and / or other electromechanical components 1174. Furthermore, the second printed circuit board 1154 may be associated with at least a sensor 1122 and a SIM ("Subscriber Identification Module") mechanism 1162. In other examples, the arrangement of other components will be considered to perform the functions of the urine flow meter described herein.

[0062] In some cases, an RFID element 1160 or a near-field radio wave transmitting device, an identification beacon, etc., can be used to facilitate the reprocessing and tracking of the handle 1102. For example, the RFID element 1160 may contain identification information for the handle 1102, such as an identification number or data. This identification information may be used to associate the handle 1102 with a specific patient or specific use of the urination device 1100. The identification information may also be used to track the handle 1102 throughout the reprocessing process, which includes tracking the handle 1102 throughout the disinfection process. The identification information may also facilitate real-time updates of inventory, such as being used to determine which units are ready for use with new patients, for example, whether a unit has been reset to factory standards, sterilized, or processed as desired. Thus, it may be easier to maintain inventory levels, including dynamically adjusting and initiating replenishment of handles or other components when inventory falls below a threshold. Handle replenishment can be performed automatically. For example, by periodically or irregularly polling the supply of handles using an RFID scanner, the supply level and category of the handles (e.g., awaiting processing, processed, etc.) can be easily determined using responses from RFID or other elements.

[0063] Reprocessing can be facilitated by the Global Positioning System ("GPS") localization of the handle 1102. In some examples, the handle 1102 may include a GPS assembly or other position sensors or elements to facilitate the determination of the coordinates and / or relative position of the handle 1102. As described herein, the handle 1102 may be communicably connected to various remote computing systems. Thus, the GPS assembly of the handle 1102 can determine information corresponding to the position of the handle 1102, which is transmitted wirelessly and sequentially to the remote computing system. The remote computing system may track the position of the handle 1102 and determine that the handle 1102 is located at the reprocessing location, the patient, the healthcare provider, or one or more other locations. The GPS assembly can be used to dynamically and automatically provide location information to a server both during patient use and after processing is complete. This allows for the automatic input of data into a patient log or other relevant application used by the patient, which can then be associated with additional metadata stored, such as patient urination. The GPS assembly may communicate with the U.S. Global Positioning System, the Russian GLONASS system, or other satellite positioning systems. The handle may also determine coordinates and / or relative positions using cellular network triangulation.

[0064] Referring to Figure 3A, one or more device processing elements 252 are substantially any kind of electronic device capable of processing, receiving, and / or transmitting instructions. For example, a device processing element 252 may be a microprocessor or a microcontroller. In addition, a first device processing element 252 may control selected components of the urination device 200, and a second device processing element 252 may control other components, but it should be noted that the first and second device processing elements 252 may or may not communicate with each other. In addition or instead, one device processing element 252 may perform a step or process for processing selected data, and different device processing elements 252 may perform other data processing steps, but the different device processing elements 252 may or may not communicate with each other.

[0065] One or more memory components 254 may store electronic data used by the urination device 200, for example, to store data collected by the liquid level sensor 262, as well as instructions for the device processing element 252. In some examples, one or more memory components 254 may be one or more magnetic hard disk drives, solid-state drives, magneto-optical memory, flash memory, electrically erasable programmable read-only memory ("EEPROM"), erasable programmable read-only memory ("EPROM"), ferromagnetic RAM, holographic memory, printed ferromagnetic memory, or non-volatile memory. In other examples, memory 254 may be any volatile computer-readable media device that requires power to maintain its memory state. In one example, memory 254 is random access memory ("RAM"). Other examples may include dynamic RAM and static RAM, or combinations of one or more types of memory components.

[0066] The power supply 256 provides power to the selected components of the urination device 200. Depending on the specific application, the power supply 256 may be a battery (e.g., a battery 272 housed within the handle 202 of the urination device 200, as illustrated in Figure 2C), a power cord, or other element that transmits electrical power to the components 250 of the urination device 200. As illustrated in Figure 2C, the battery 272 is accessible via a removable cover 276 which may be located on the underside of the handle 202. The cover 276 may be attached to the handle 202 by one or more fasteners 278. Alternatively, as illustrated in Figures 2I-2J, for example, the handle 1102 of the example urination device 1100 may include an upper 1103 and lower 1105 integrated shell housing an inaccessible battery 1164. The battery 272 or 1164 may be rechargeable by a power cord or an inductive charging station 114, as shown in Figure 18, for example. The device processing element 252 may determine the status of the handheld urination device, receive information from the charging station via the input / output interface 258, and indicate through an indicator, such as an LED, that it is ready for continuous use.

[0067] A clock is any device that can record time or measure time or date data. In one example, a clock is a piezoelectric quartz oscillator. In another example, a clock is an atomic clock, a radio receiver that communicates with standard time, or any other electrical or mechanical device that outputs time or date data. In yet another example, a clock is incorporated into device processing element 252.

[0068] The urination device 200 has a measurable outflow rate. For example, the outflow rate of the urination device 200 at a given time can be determined based on the urine level in the flow chamber 204. As shown in Figure 2A, in one example, the outlet 204b is formed as a vertically extending slot. In various examples, the width of the outlet 204b increases as it extends upward from the bottom wall 218 of the flow chamber 204 toward the edge 210 (for example, forming a triangular opening). This slot allows the outflow rate of the urination device 200 to increase as the liquid level rises in the flow chamber 204, preventing urine from overflowing from the flow chamber 204. To improve the system's "low flow" sensitivity, the outlet 204b restricts urine outflow at low flow rates and increases outflow at higher flow rates to prevent overflow or backflow (i.e., not very high sensitivity is required here).

[0069] Figures 2H–2J illustrate another example of the urination device 1100. The outlet of the urination device 1100 can be defined by a T-shaped slot. Furthermore, the example of the urination device 1100 in Figures 2H–2J shows a urination device 1100 having an outlet 1104b. The outlet 1104b is generally defined by a T-shaped slot that penetrates the outer wall of the flow chamber 1104. The outlet 1104b generally increases the volume range within the flow chamber 1104, allowing for highly accurate flow measurements over this range. For example, the outlet 1104b generally restricts fluid from flowing out of the flow chamber 1104 when the flow chamber 1104 contains a relatively small amount of fluid. The structural member 1130a may be configured to maintain accurate readings from the sensor 1122 during periods of high fluid flow. In another example, the float 1130b generally restricts fluid outflow from the flow chamber 1104 when the flow chamber 1104 contains a relatively small amount of fluid. This allows for smaller urine flow rates and thus helps to enhance or improve the sensitivity of the relevant flow measurement in this configuration by restricting the outflow of fluid from the flow chamber 1104. As the volume of fluid in the flow chamber 1104 increases, the outlet 1104b can reduce its fluid restriction and allow an increasing amount of fluid to flow out. Alternatively, as the volume of fluid in the flow chamber 1104 increases, the float 1130b rises, thereby allowing the increased fluid to be discharged through the outlet 1104b. This allows for higher urine flow rates where a less sensitive flow measurement may be required. The outlet 1104b also includes an elongated opening positioned above and connected to a triangular opening. This elongated opening can reduce overflow or backflow conditions by allowing excess fluid to be released, for example, when the flow chamber 1104 approaches its maximum capacity. It should be understood that the shape and configuration of outlet 1104b are illustrative for illustrative purposes only. In other examples, other shapes and configurations of the outlet are possible to facilitate the various functions of the urination device 1100 described herein.

[0070] The urination device 200 measures one or more parameters of the patient's urine urination. For example, the flow chamber 204 collects urine and one or more sensors can measure the parameters of the urine. In one example, the urination device 200 measures the date and time of urination, the volume of urine, the average void flow rate, the duration of urination, the flow time, the maximum urine flow rate, and the time to reach the maximum urine flow rate.

[0071] The input / output interface 258 provides communication to and from the urination device 200 to external devices and / or the user. The input / output interface 258 may include one or more input buttons, communication interfaces (such as Wi-Fi®, Ethernet®, Bluetooth®, NFC, RFID, cellular, infrared, or other optical communication), and communication components (such as a Universal Serial Bus (USB) port / cable). In various examples, the input / output interface 258 transmits sensor data from the urination device 200 to a remote computing device such as a remote server 112. The input / output interface may also transmit data to a healthcare provider device 109, a reporting device 110, a third-party device 103, a user mobile device 108, or a charging station 114.

[0072] One or more verification sensors 260 may be substantially any type of electronic device capable of measuring the orientation of the urination device 200. One or more verification sensors 260 may be orientation sensors such as a gyroscope or accelerometer for measuring the orientation of the urination device 200. In addition or alternatively, one or more verification sensors 260 may be a capacitive sensor (or electrostatic sensor) or resistive sensor for proximity detection. For example, a capacitive sensor on the handle may determine that the handle is being held in the user's hand and measure the proximity between the human body and the device. In another example, the device processing element 252 may detect that a user is gripping the device using a verification sensor 260 such as a capacitive sensor and estimate the orientation of the urination device 200 from the user's grip.

[0073] The verification sensor 260 may work in conjunction to automatically turn the device's power on / off. In various examples, both the accelerometer and the capacitive sensor are used to automatically activate the urination device 200 (for example, the device is activated when the accelerometer detects motion and the capacitive sensor detects a user grip). For example, when the urination device 200 is otherwise idle, it may power the accelerometer. When the accelerometer detects motion, this may power the proximity sensor, enabling it to detect user contact. If both the accelerometer and the proximity sensor detect motion corresponding to an impending urination, such as the user gripping the handle and orienting the device to a specific position, the urination device 200 may power the device processing element 252 to prepare the urination device 200 for receiving flow data. In other cases, it may be sufficient for either the accelerometer or the proximity sensor to detect a value exceeding a certain threshold or within a selected range to activate the urination device 200.

[0074] One or more verification sensors 260 may measure the orientation of the urination device 200, and this orientation data may be stored in memory 254. In various examples, the urination device 200 is automatically turned on depending on its orientation, for example, by a capacitive sensor. For example, if the urination device 200 is positioned in a suitable orientation for use, as detected by one or more verification sensors 260, one or more device processing elements 252 may supply power to the urination device 200 via battery 272, thereby turning on the urination device 200 for use. Powering on the device when it is in the appropriate orientation may occur automatically or may be easily done via a power button. For example, the urination device 200 may include a power button 279 (see, for example, Figures 2A and 2B) that allows the user to manually turn the urination device 200 on or off.

[0075] In other examples of the urination device 200, an LED light may illuminate when the device is in the correct, desired, or optimal position relative to the patient's body. In addition or instead, the urination device 200 may include a display, such as an LED display. The LED display may be integrated into the handle of the urination device 200 and may be coupled to one or more verification sensors 260 and / or other sensors. The display may indicate the current or instantaneous orientation of the urination device 200, including pitch and / or roll states or values. As described herein, the urination device 200 may have a target state or target orientation associated with the optimal operation of one or more components of the urination device 200, such as a displacement sensor 222. In this regard, the display may indicate the current orientation of the urination device 200 relative to the target state or target orientation. If the current orientation coincides with and / or is within the acceptable range of the target, the urination device 200 may be in a state to accept the patient's urine flow.

[0076] Figure 3B is a simplified block diagram of additional components within or associated with server 112. Server 112 may include one or more server processing elements 152, a power supply 156, memory 154, and one or more input / output interfaces 158. Each element of server 112 may be connected via one or more system buses 166.

[0077] Referring to Figure 3B, one or more server processing elements 152 are substantially any kind of electronic device capable of processing, receiving, and / or transmitting instructions. For example, a server processing element 152 may be a microprocessor or a microcontroller. In addition, a first server processing element 152 may control selected components of the server 112, and second or subsequent server processing elements 152 may control other components, but it should be noted that the first and second server processing elements 152 may or may not communicate with each other. In addition or instead, one server processing element 152 may perform a step or process for processing selected data, and different server processing elements 152 may perform a step for processing other data, but the different server processing elements 152 may or may not communicate with each other. In addition, a certain data processing step or process may be executed by one or more device processing elements 252, and other data processing steps or processes may be executed by one or more server processing elements 152, but each processing element may or may not communicate with one another.

[0078] One or more memory components 154 may store electronic data used by the server processing element 152, and similarly, they may store data collected by, for example, the urination device 200, the user mobile device 108, the healthcare provider device 109, the reporting device 110, and / or third-party device 103. The exemplary memory device 254 described for the urination device 200 may also function as an exemplary memory device 154. The memory device 154 may be the same type of device as the memory 254 of the urination device 200, or it may be different.

[0079] The power supply 156 provides power to the selected components of the server 112. Depending on the specific application, the power supply 156 may be a power cord, a rectifier that converts AC to DC, a transformer, or any other element that transmits electrical power to the server 112. The power supply 156 may include a backup battery to continue supplying power to the server in the event of a power grid failure.

[0080] The input / output interface 158 provides communication to the server 112 and communication from the server 112 to external devices and the network 102. The input / output interface 158 may include communication interfaces (such as Wi-Fi®, Ethernet®, Bluetooth®, NFC, RFID, fiber optic, cellular, infrared, or other optical communication), communication components (such as a Universal Serial Bus (USB) port / cable), and human interface components (such as a keyboard, mouse, stylus, monitor, touchscreen, microphone, and speaker). In various examples, the input / output interface 158 receives sensor data from the urination device 200 and records the data in memory 154 for further processing by the server processing element 152. For example, the server processing element 152 may verify whether the data is related to urination, process the sensor data to calculate the urine flow rate and total urine volume urinated for each urination event, reprocess the data and store the data, read out the analysis data, and / or generate a report. In other examples, an approximate flow rate calculation is sent to the server. In another example, the input / output interface 158 sends raw data to server 112 or another device. In yet another example, the input / output interface sends filtered data to server 112 or another device.

[0081] In addition, although it is described that various methods and operations are performed by the device processing element 252 of the urination device 200, it should be noted that some operations may be performed entirely or partially by external processing elements such as the server processing element 152, or the server 112 which has other processing elements associated with the healthcare provider device 109, the third-party device 103, the user mobile device 108, the reporting device 110, or other devices. The descriptions of specific processing elements are for illustrative purposes only.

[0082] Figure 4 discloses a flowchart of Method 400 for determining flow events detected by the urination device 200 and associated parameters. This method may be performed while a flow event is occurring, or after the urination device 200 has detected that a flow event has occurred and has sent the unanalyzed data for processing to the server 112 or other device via the network. In some cases, a device processing element 252 may perform some analysis on the data while a server processing element 152 performs other analysis on the data. In some cases, activation of Method 400 may be determined based on the urination device 200 being "activated," such as when a user puts the urination device 200 into an active state, when a proximity sensor detects a user gripping the device, and / or when a liquid level sensor detects an increase in the liquid level of the urination device 200, or when the urination device 200 detects that a flow event is about to occur.

[0083] The method can begin with operation 402, in which a device processing element 252 or a server processing element 152 receives or records the initial liquid level in the flow chamber 204. In one example, the liquid level corresponds to the angular position Φ of the float 230 of the urination device 200. For example, if the flow chamber 204 is not substantially filled with fluid, as shown in Figure 2E, each processing element receives the position of the float 230, such as indicated by the angular position Φ1. The float 230 may also be at a lower limit position indicating that the flow chamber 204 is empty, and this position is provided to each processing element. In another example, the position of the float 230 is detected with an initial value before use, or read from memory 254 as a default initial value. In one example, the position of the float 230 is an angular displacement or angular position value Φ received from a displacement sensor 222, such as a Hall effect sensor. In another example, the position of the float 230 is a linear displacement or linear position value received from a displacement sensor 222. In another example, the liquid level corresponds to the capacitance value of a capacitance sensor.

[0084] In operation 402, the device processing element 252 or the server processing element 152 receives or records the initial position or orientation of the urination device 200 in three-dimensional space, indicating the initial pitch value of the urination device 200 and optionally the initial roll value, as detected by the verification sensor 260. In one example, the verification sensor 260 indicates that the urination device 200 is pitching in a range where the flow chamber 204 rotates downward relative to the handle 202 around an axis parallel to the pivot axis 232. In another example, the verification sensor 260 indicates that the urination device 200 is pitching in a range where the flow chamber 204 rotates upward relative to the handle 202 around an axis parallel to the pivot axis 232. In yet another example, the verification sensor 260 indicates that the urination device 200 rolls asymmetrically in either direction around an axis perpendicular to the pivot axis 232. The verification sensor 260 may indicate the position of the urination device 200 in any combination of pitch and / or roll in any direction around any axis. The verification sensor 260 may also indicate the position of the urination device 200 with respect to any three orthogonal axes, or with respect to a plane and axes orthogonal to that plane. The position may be detected when the urination device 200 is enabled, or during a short time window after activation (e.g., 3-5 seconds) that gives the user time to turn on the urination device 200 and subsequently begin urination. Alternatively, the initial directional position may be retrieved from memory corresponding to a typical position of the urination device 200 during urination, depending on the patient's gender. For example, a male patient may have a directional or pitch and / or roll set to the initial value corresponding to most use cases. Similarly, a female patient may have a directional or pitch and / or roll value at the time of the first discharge, corresponding to most use cases. Method 400 may read these values ​​upon activation, or dynamically update the values ​​based on the current actual position at activation or the first flow.

[0085] In operation 404, simultaneously with or after the initial float position is received and one or both of the pitch and / or roll are determined, the device processing element 252 or server processing element 152 receives a timestamp corresponding to the initial activation, or the flow rate first detected by the urination device 200. For example, the device processing element 252 may receive time and / or date information from a clock that forms the timestamp. In another example, the timestamp is a date or time, e.g., "October 8, 2018, 6:51:00 PM". The timestamp may be in any format, such as formatted for 12-hour and AM / PM information as described above, or formatted for 24-hour information, such as "October 8, 2018, 6:51:00 PM". In another example, the clock generates elapsed time between multiple flow events. For example, the clock includes a timer that resets to zero once a urination event is authenticated (as described later with respect to Figures 6A and 6B) and begins counting the elapsed time until the next authenticated urination event. The clock may take into account the time zone difference between the healthcare provider and the patient. For example, the timestamp may be recorded in Greenwich Mean Time ("GMT"). Alternatively, memory 254 may store time zone information for the patient's location and adjust the timestamp accordingly. The clock may take into account the start or end of daylight saving time and periodic variations in time, such as leap years. For example, if daylight saving time begins between urination events, the clock will adjust the time of the urination events accordingly. For example, if the urination device 200 records a urination event at 9 p.m. on Saturday, March 9, 2018, followed by the start of daylight saving time at 2 a.m. on Sunday, March 10, 2018, and then the urination device 200 detects another urination event at 6 a.m. on Sunday, March 10, 2018, the timestamp will indicate that there is no information regarding daylight saving time, so the clock will adjust the time between the two urination events to be 8 hours instead of 9 hours. In another example, the clock may record the time interval between the first detected flow or activation and the end of the flow or deactivation, for example, 20 seconds.

[0086] The method may proceed to operation 406, in which the device processing element 252 or the server processing element 152 monitors the liquid level of the flow chamber 204 over time by periodically receiving the output from the liquid level sensor 262 over a series of sampling intervals. Each processing element of the device also monitors the orientation of the urination device 200 over time by periodically receiving the output from the verification sensor 260, such as multiple orientation values. In one example, the device processing element 252 executes a command to receive electronic signals at a sampling rate of 1 sample per second, i.e., 1 Hz. In this example, the device processing element 252 reads the analog electrical signals from the liquid level sensor 262 and / or the verification sensor 260, and converts those analog signals into digital signals by a digital-to-analog converter (DAC) circuit, thereby generating values ​​from multiple liquid level sensors, values ​​from multiple verification sensors, values ​​from both, or orientation values. The DAC circuit has a specific digital resolution used to divide the analog signals into high-precision discrete digital values. For example, the DAC divides the analog signals into 2 12The DAC may have a 12-bit digital resolution, that is, it divides the data into 4,096 discrete digital pieces of information. The DAC may have a lower or higher resolution, such as 8 bits, 10 bits, 16 bits, 32 bits, or other values. In addition, the DAC may have a lower or higher sampling frequency, which defines the number of sampling intervals per given period. For example, the DAC may have sampling frequencies such as 0.1 Hz, 10 Hz, or 100 Hz, which define a sampling interval of one sampling every 10 seconds, 10 sampling intervals per second, or 100 sampling intervals per second, respectively. The sampling frequency may be varied based on the desired sensitivity, expected flow rate, etc. The device processing element 252 may read these digital pieces of information to monitor the position of the displacement sensor 222, further process or refine the digital pieces of information, and store and read some or all of it in the memory 254. In another example, the device processing element 252 simply records input values, such as those received directly or indirectly from the sensor, in the memory 254.

[0087] Continuing operation 406, the device processing element 252 or the server processing element 152 monitors several parameters relating to the liquid level in the flow chamber 204 to determine several different outputs. In one example, the device processing element 252 monitors the position of the float 230. In one example, the device processing element 252 monitors the angular position Φ of the float 230 over time and records that the float initially rises as the fluid flow increases. In one example, as shown in Figure 2E, the float 230 starts from a lower position indicated by Φ1, where the float 230 is stationary on the inner surface of the bottom wall 218 of the flow chamber 204. As fluid flows into the flow chamber 204, the angular position Φ of the float 230 can move to a higher value, for example, Φ2, as shown in Figure 2F. For example, as shown in Figure 2G, when the fluid flow reaches its peak value, the angular position of the float 230 can reach the peak value Φ3. During a flow event, as fluctuations occur in the flow rate entering or leaving the flow chamber 204, the angular position Φ of the float 230 can move up and down. As the fluid flow decreases, the angular position Φ of the float 230 may decrease over time, eventually returning substantially to the float's initial position Φ1. These fluctuations are captured by the device processing element 252 at desired intervals over the time frame of the flow event and, if desired, stored in memory 254 or transferred to another device, such as a server processing element 152. In another example, the device processing element 252 monitors the capacitance value of a capacitance level sensor corresponding to the liquid level in the flow chamber 204.

[0088] In operation 406, the device processing element 252 or the server processing element 152 monitors the orientation of the urination device 200 by receiving a signal from the verification sensor 260. The verification sensor 260 monitors the pitch and / or roll of the urination device 200 in three-dimensional space. The orientation of the urination device 200 in three-dimensional space can affect the outflow rate from the outlet 204b. For example, if the urination device 200 pitches with the outlet 204b in a substantially downward position relative to the handle 202, the outflow rate of fluid can be increased compared to a position where the urination device 200 is held in a near-horizontal direction. For example, the verification sensor 260 indicates the number of angles from the horizontal plane to which the urination device 200 is pitching. The verification sensor 260 may also indicate the direction of pitch, such as downward or upward, and this direction is defined relative to the handle or other predetermined point of the device 200. In another example, the verification sensor 260 indicates the degree and direction of roll from the horizontal plane, for example, 20° to the left. In another example, the urination device 200 is symmetrical with respect to an axis perpendicular to the pivot axis 232, and the verification sensor 260 shows a non-directional roll. In yet another example, the verification sensor 260 shows the urination device 200 with an offset degree and direction relative to each of the three orthogonal axes, for example, 10° from the z axis, -20° from the y axis, and 5° from the x axis.

[0089] This method may proceed to operation 408, in which the device processing element 252 or the server processing element 152 receives information that the liquid level in the flow chamber 204 is at a limit position. For example, the liquid level sensor 262 may indicate that the flow chamber 204 is empty. In one example, the device processing element 252 receives information that the float 230 is at a limit position, indicating that the corresponding liquid level is at a limit position. For example, as shown in Figure 2E, the float 230 may be stationary with its back to the inner surface of the bottom wall 218 of the urination device 200 when measured at angular position Φ1. In another example, as shown in Figure 2F, the float 230 may be at another position, such as angular position Φ2 as shown in Figure 2F. The device processing element 252 may use the movement of the liquid level from the lower limit position Φ1 and then back to substantially the same lower limit position Φ1 to detect the start and end of a flow event. For example, as the flow of fluid into the flow chamber 204 decreases, the float 230 may move to a lower position as the fluid continues to flow out of the outlet 204b. The float 230 may also move to a higher position over the course of urination due to changes in flow rate, changes in the position of the urination device 200, and changes in shaking or other vibrations. Over time, the liquid level position should tilt downward as the flow decreases and stops. Finally, when the fluid flow stops and the remaining fluid in the flow chamber 204 flows out, the liquid level reaches a lower limit position indicating the end of the flow event. For example, the float 230 may reach the end of its movement path, such as a mechanical stop position. One example of a mechanical stop position is the float 230 in contact with the inner surface of the bottom wall 218 of the flow chamber 204. Another example of a mechanical stop position may be a mechanical limit incorporated into one or both of the accelerators 236a, 236b. In another example, the lower limit position of the float 230 may be an electrical limit position or a sensor limit position. For example, the displacement sensor 222 senses the rotational position within a certain limit, but if it exceeds that limit, it senses the maximum or minimum value of the rotation as needed.The lower limit may be detectable by a verification sensor 260 and / or separate limit sensors that output a signal when the float 230 reaches its limit, for example, when the arms 234a and 234b come to rest relative to a mechanical stop position including proximity sensors. During a flow event, an end timestamp indicating the end of the interval may be recorded. In another example, the capacitance value of a capacitive level sensor indicates the limit position of the liquid level in the flow chamber 204.

[0090] Once the liquid level reaches the lower limit, the flow event is considered to have ended, i.e., it is presumed that there is no fluid remaining in the compartment. There may be a waiting period after the liquid level reaches its lower limit to capture any possible secondary flows that may occur. Once the flow event is considered to have ended, the method may proceed to operation 410, in which the processing element determines the flow data corresponding to the flow event. In one example, the device processing element 252 of the urination device 200 transmits the unanalyzed liquid level and the position information of the urination device 200 to the server 112 via the cellular network. The server processing element 152 analyzes the liquid level in the flow chamber 204 over the flow interval time. In one example, the device processing element 252 or the server processing element 152 uses the verification sensor 260 to analyze the angular position Φ of the float 230 (e.g., Φ1, Φ2, Φ3, and the positions in between, as illustrated in Figures 2E-2G) and the direction of the urination device 200 (e.g., pitch and / or roll) over the time interval of the flow event. The server processing element 152 uses time data, angular position data, and position data in three-dimensional space to determine the input flow rate and / or accumulated flow volume. For example, the flow rate can be determined by using the angular position Φ of the float, predetermined characteristics of the urination device 200 with respect to the orientation of the urination device 200, and detection data. The predetermined characteristics may be stored in the memory 254 of the urination device 200, or in the memory of the server 112 or another device.

[0091] In one example, the device processing element 252 or the server processing element 152 interpolates or transforms the input flow rate from predetermined characteristics in the form of a lookup table or other relational structure, using liquid level data and / or directional values, such as the position of a liquid level sensor. In one example, the device processing element 252 or the server processing element 152 interpolates the input flow rate from predetermined characteristics in the form of a lookup table, using the angular position Φ of the float and the orientation of the urination device 200 (e.g., pitch and / or roll). To increase the sensitivity of flow measurement, the urination device 200 has an outlet 204b which may be shaped so that the outlet flow is less when the corresponding inlet flow is less. The outlet 204b may also have a larger outlet flow when the corresponding inlet flow is larger, in order to prevent urine from overflowing from the flow chamber 204. The shapes of the flow chamber 204 and the outlet 204b of the urination device may also differ between male and female devices to increase sensitivity in the effective range of the target urine flow. In other words, the flow chamber and outlet can be configured to optimize high-precision collection, direction, and / or user comfort according to the user's anatomical structure and typical urination position. This helps ensure that the fluid is properly taken up and accurately measured during the urination event, while allowing the user to comfortably handle the urination device during the event.

[0092] The urination device 200 may have outlets 204b having different outlet flow characteristics at different orientations of the urination device 200, for example, different pitches, rolls, and / or positions of the liquid level sensor 262, and by detecting changes in these characteristics, the flow characteristics (e.g., flow rate, volume, time, duration, peak, start, and / or end) can be determined. Tables 1A, 1B, and 1C below show exemplary relationships between these values.

[0093] [Table 1A]

[0094] [Table 1B]

[0095] [Table 1C]

[0096] Referring to Tables 1A, 1B, and 1C above, in one example, at a specific point in time or snapshot (such as a specific sampling interval) during a flow event, the urination device 200 has a flow chamber 204 at a downward angle relative to the handle 202, a pitch of 30° from the horizontal on an axis parallel to the pivot axis 232, a roll of 12° from the horizontal on an axis perpendicular to the pivot axis 232, and the angular position Φ of the float 230 is 18°. Continuing the above example, the memory 154 of the server 112 includes the following predetermined output flow rate characteristics at an angular position of 10° for the float 230. See Table 1A. The memory includes an outlet flow rate of 12 mL / sec corresponding to a pitch of 20° and a roll of 10°. Memory 154 includes a predetermined output flow rate of 25 mL / sec at a 40° pitch and 10° roll, a predetermined output flow rate of 17 mL / sec at a 20° pitch and 20° roll, and a predetermined output flow rate of 32 mL / sec at a 40° pitch and 20° roll. As illustrated, at the angular position of the float 230 at 20°, the memory includes the following predetermined output flow rate characteristics, an outlet flow rate of 17 mL / sec corresponding to a 20° pitch and 10° roll, and memory 154 includes a predetermined output flow rate of 35 mL / sec at a 40° pitch and 10° roll. Furthermore, memory 154 includes a predetermined output flow rate of 23 mL / sec at a 20° pitch and 20° roll, and a predetermined output flow rate of 45 mL / sec at a 40° pitch and 20° roll.

[0097] The server processing element 152 or the device processing element 252 uses interpolation, for example, bilinear interpolation, to determine that the outlet flow rate is 19.7 under the conditions in Table 1A and 27.6 mL / sec under the conditions in Table 1B. Subsequently, each processing element interpolates from Tables 1A and 1B between the outlet flow rate value at a predetermined floating angle position φ of 10° and the outlet flow rate value at a predetermined floating angle position φ of 20°, given that the actual float position Φ is 18°. Each processing element determines that the outlet flow rate is 23.65 mL / sec. See Table 1C. Each processing element may use other types of interpolation, such as linear interpolation, cubic interpolation, bicubic interpolation, one-dimensional nearest neighbor interpolation, or two-dimensional nearest neighbor interpolation. In various examples, the server processing element 152 determines the outlet flow rate using one of the pitch, roll, or liquid level sensor 162 position inputs, or any two of any combination of these inputs.

[0098] Next, the server processing element 152 or the device processing element 252 determines the inlet flow rate using the angular position Φ of the float 230 and the interpolated outlet flow rate. For example, the inlet flow rate is determined by adding the change in volume held in the flow chamber 104 since the last sampling interval to the output flow rate. If the liquid level sensor 262 rises from one sampling interval to the next, then more fluid volume is held in the flow chamber 204 at the current sampling compared to the previous sampling, and accordingly the input flow rate is higher than the outlet flow rate. Similarly, if the liquid level sensor 262 falls at the current sampling interval compared to the previous sampling interval, then the outlet flow rate is higher than the inlet flow rate. This held volume is determined from a lookup table using a similar method and input (e.g., pitch, roll, and position of the liquid level sensor 262) as the outlet flow rate exemplified in Tables 1A, 1B, and 1C.

[0099] In another example, the predetermined characteristics take the form of a mathematical relationship where the angular position φ, pitch, and optionally roll of the float 130 are inputs, and the input flow rate is output. In one example, the server processing element 152 determines the urine flow rate by analyzing the outflow flow rate using data on the angular position Φ of the float 230 and / or the directional data of the urination device 200. Specifically, the server processing element 152 (or device processing element 252) uses the position of the float 230 over the detection period, taking into account the known discharge volume of the flow chamber 204, to determine, for example, the velocity of the flow entering the flow chamber 204 from the user. The above is merely illustrative, and the flow rate input to the urination device 200 can be determined by other means.

[0100] This method may proceed to operation 412, in which the device processing element 252 or server processing element 152 determines the total fluid flow volume for the event. For example, the server processing element 152 may numerically integrate the fluid input signal over time, as determined from the liquid level data and the position information of the urination device 200, as determined in operation 410. In one example of a method for numerically integrating the urine flow rate, the server processing element 152 uses a left end-point rectangular approximation to obtain an estimate of the fluid flow accumulated over time. Each processing element may use flow data, such as the data determined in operation 410, to estimate the accumulated amount of fluid over a time step and store the result in memory 254. For example, if the device processing element 252 or server processing element 152 samples the fluid flow rate at a sampling interval of 0.1 seconds, the accumulated amount at any given sampling interval can be obtained by multiplying the sampled value of the flow rate by the time step (e.g., 0.1 seconds). Next, for example, if the device processing element 252 or the server processing element 152 samples the fluid flow rate 5.0 seconds after the start of the fluid flow, the fluid flow rate may be 7 milliliters per second (mL / sec). Each processing element multiplies 7 mL / sec by 0.1 seconds to obtain an accumulated fluid volume of 0.7 mL in a time step of 5.0 to 5.1 seconds. Next, each processing element adds 0.7 mL to the accumulated fluid volume from the previous time step and stores the result in memory 254. In other examples, each processing element may use left-end approximation, right-end approximation, trapezoidal approximation, midpoint approximation, Simpson's method approximation, parabolic approximation, or other approximations to determine the accumulated fluid volume. Operation 412 may obtain a vector of data points for the accumulated fluid volume, or a corresponding vector for the associated time. The device processing element 252 may store these vectors in memory 254, or the server processing element 152 may store these vectors in memory 154.Similarly, other types of calculations incorporating the characteristics of the urination device 200 and flow rate data can be performed to determine the cumulative flow rate.

[0101] This method may proceed to operation 414, in which the server processing element 152 or the device processing element 252 stores the flow event data in memory storage such as the device itself in memory 254, or the server 112 in memory 154. In various examples, the flow event data is raw data or filtered data. In one example, the device processing element 252 transmits the flow event data to the server 112 via a network 102 such as a cellular network, and the server 112 stores the flow event data in the server 112's memory. Alternatively, the device processing element 252 transmits the flow event data to a healthcare provider device 109, a reporting device 110, a third-party device 103, or any combination thereof. Alternatively, the device processing element 252 of the urination device 200 transmits the flow event data to the server 112 via a network 102 which may be a private network such as a cellular network, a public network such as the Internet, or a combination thereof.

[0102] In many cases, the urination device 200 does not correspond to actual urination, but instead may detect flow events in which the user is rinsing or washing the urination device 200. Figure 5 is a flowchart illustrating a method 500 for verifying that flow event data is related to a urination event. By authenticating the data as being linked to an actual urination event rather than another event (e.g., the user washing the urination device 200, an unintended sensor detection, etc.), the system can avoid analyzing and transmitting irrelevant data, which can help improve the accuracy and efficiency of the device. For example, the device processing element 252 may analyze one or more authentication characteristics detected by various verification sensors 260 within the urination device 200. In particular, the server processing element 152 or the device processing element 252 may analyze authentication characteristics such as the acceleration of the urination device during a flow event, the orientation of the urination device during a flow event, the orientation of the user's hand on the urination device during a flow event, the temperature of the fluid flowing through the urination device during a flow event, or the total amount of fluid flowing through the urination device during a flow event. Specifically, the device processing element 252 can verify the detected flow event data to determine whether the flow event data is related to a urination event, or to some other type of event, such as cleaning the urination device 200 or accidentally dropping the urination device 200 into the toilet.

[0103] The device processing element 252 can perform method 500 to determine that the flow event data is potentially valid urination data. A server processing element 152 with superior processing capabilities may receive the authenticated urination data and perform method 500 again on data with different thresholds to double-check the validity of the data or to perform analysis to more accurately determine the validity of the data. Alternatively, the operation or part of the operation of method 500 may be performed on the device processing element 252, and other operations may be performed on the server processing element 152, or on other processing elements associated with the healthcare provider device 109, third-party device 103, user mobile device 108, or reporting device 110. Method 500 may be performed while a flow event occurs, or after a flow event has occurred and the urination device 200 has detected that it has sent the data via the network 102 to an onboard processor, server 112, or other device for analysis and / or filtering.

[0104] This method may begin in operation 502, in which the server processing element 152 or device processing element 252 receives flow event data, such as data detected in method 400 and / or data from a storage location (e.g., memory 154 on the server, healthcare provider device 109, reporting device 110, user mobile device 108, or third-party device 103), from the location of memory 254 in the urination device 200 or via the network 102. In another example, the server processing element 152 receives unanalyzed flow event data from the urination device 200 via the network 102. In another example, the processing element corresponds to the healthcare provider device 109 and receives flow event data either directly from the urination device 200 or indirectly via the network 102. In another example, the processing element is located in the reporting device 110 and receives flow event data either directly from the urination device 200 or indirectly via the network 102. In yet another example, the processing element is located within a third-party device 103 and receives flow event data directly from the urination device 200 or indirectly via the network 102.

[0105] After receiving flow event data, the server processing element 152 or device processing element 252 may then analyze the data for various sensors, authentication characteristics, and characteristic thresholds to determine whether the data is valid. This method may proceed to operation 504, in which each processing element determines whether the orientation of the float 230 and / or the orientation of the urination device 200 itself is correct for the detected flow event. The orientation can be determined based on the position of the displacement sensor 222 and the three-dimensional position / orientation of the urination device 200. For example, if flow is detected through the outlet 204b when the float 230 is in an abnormal position, such as at its upper limit, each processing element may determine that a rinse event has occurred. As another example, if the verification sensor 260 detects a high acceleration value over the event time, each processing element may determine that the user was lightly tapping the urination device 200 during the rinse event. For example, each processing element may determine that the float 230 reached its upper limit position during the flow event and thereby clip the flow event data. This condition may indicate a large-volume flow, similar to that from a faucet, when the user rinses the urination device 200.

[0106] In another example, the float 230 may be detected in an intermediate position after a flow event has ended, indicating that the flow chamber 204 contains some fluid or, in some cases, that the float 230 has stopped moving. In one example, each processing element receives the position of the float 230 over time to determine whether the float 230 did not move, for example, whether it was stable, not swaying, or not moving irregularly. For example, if the float 230 was at the lower limit position or a specific other initial starting position and did not move from that position or was near it for a given period of time, each processing element may determine that the urination device 200 was stable enough to make accurate measurements. In another example, if the initial position of the float 230 fluctuates irregularly over time, each processing element may determine that the urination device 200 was not stable enough to make accurate readings. In one example, each processing element monitors the position of the float 230 to determine whether the position of the float 230 contains signal noise or other changes unrelated to the urination event. In one example, the device processing element 252 (or server processing element 152, or another device) detects the orientation of the urination device 200 based on input from the verification sensor 260 and / or the liquid level sensor 262, compares the position of the urination device 200 with the position of the urine event, and determines that the detected orientation is valid. The position of the urine event may be predetermined and stored in the memory 254 of the urination device 200 or in the memory of another device.

[0107] The location of urinary events may vary among different patients depending on various factors. For example, the location of urinary events may depend on the patient's sex (e.g., the location of urinary events corresponds to a seated position in female patients and a standing or seated position in male patients). On the other hand, if, for example, the patient is unable to walk and uses a wheelchair or other assistive devices, the location of urinary events will correspond to different patient positions. Figure 12 illustrates the output from the validation sensor 260, showing the change in acceleration of the urination device 200 associated with different events such as placing the urination device 200, urinating, and rinsing. Large changes in acceleration may indicate an unstable state in which the urination device 200 cannot make accurate readings. Various sensors and / or thresholds can be analyzed simultaneously, independently, or sequentially, depending on the desired processing speed and robustness of the urination device 200. Therefore, it should be understood that the following description of operations should be performed in any order or timing, and various operations may be omitted or skipped as needed.

[0108] In addition, the server processing element 152 or the device processing element 252 may analyze the directional output to determine whether the urination device 200 was in a suitable position to collect urine event data. For example, if the verification sensor 260 indicates that the urination device 200 was not in a position where the substantially correct side was facing upward (e.g., upside down with the opening of the flow chamber 204 facing the ground, sideways, tilted too far up or down perpendicular to an axis parallel to the pivot axis 232, and / or tilted too far left or right perpendicular to an axis perpendicular to the pivot axis 232), the respective processing element will determine that the urination device 200 was not in a suitable position to collect urine event data. However, if the values ​​of the verification sensor 260 over time indicate that the urination device 200 was in a suitable position to receive urine event data, method 500 may proceed to operation 506. An example of the output from the verification sensor 260 is illustrated in Figure 12. Figure 12 shows acceleration change data 1200, such as the angle of the urination device 200 from an upright position, for different actions such as placing 1202, urinating 1204, and rinsing 1206. Figure 14 illustrates the superposition of acceleration changes like those in Figure 12, positioning errors like those in Figure 13, and different events, showing, for example, how urination and rinsing can be distinguished from each other.

[0109] Figures 12 to 14 illustrate various thresholds for different events. For example, Figure 12 shows that the acceleration does not change much in the region 1202 when the urination device 200 is placed, or in the region 1204 during urination, but changes significantly during rinsing 1206. Figure 13 shows positioning error data 1300. As in Figure 12, Figure 13 shows that the positioning error data 1300 does not change by approximately 120 degrees when the urination device 200 is placed 1302, the positioning error is approximately 0 degrees during urination 1304, and the positioning error fluctuates irregularly during rinsing 1306. Figure 14 shows a combination 1600 of positioning error data 1300 and acceleration data 1200, which can be used to distinguish between placing the urination device 200 1602, the urination event 1604, and the rinsing event 1606. For example, each processing element may determine that urination has occurred if both conditions are met, such as when the device movement falls below a threshold, as in region 1204 of Figure 12, and when the positioning error is within a specific threshold, as in region 1304 of Figure 13. The device processing element 252 and the server processing element 152 may use different thresholds or criteria to determine the validity of the urination event. Each processing element may use acceleration change data 1200 and positioning error data 1300 individually or in any combination to distinguish between different types of events. However, by superimposing the acceleration change data 1200 and positioning error data 1300 onto the combined data 1600, each processing element may be able to distinguish between different types of events more accurately than with a single dataset.

[0110] In operation 506, the server processing element 152 or the device processing element 252 determines whether the fluid flow data associated with a flow event is within a specific limit for urine flow by comparing the flow data with various thresholds. The thresholds may be predetermined, learned by each processing element from the history of a given patient, learned from typical data of patients with similar age, sex, ethnicity, height, weight, and medical condition or medical history, or a combination of such thresholds. For example, each processing element may compare the detected fluid flow rate to the flow rate of a characteristic urine event. The flow rate of a characteristic urine event may be determined based on values ​​typical for patients with similar demographics (e.g., sex, age, or ethnicity) to the current patient, or may be learned over time for a specific patient. For example, the fluid flow rate may be too high or too low compared to a human-specific, typical, or possible urine flow threshold. In another example, the total cumulative fluid volume may be too high or too low compared to a human-specific, typical, or possible urine volume threshold. For example, a total cumulative fluid volume of urine for any single urination event of 3 gallons would be too high for any individual. In another example, the peak flow rate may be too high or too low compared to a typical or possible value for a person. For example, a peak fluid flow rate of 100 gallons per minute of urine would be too high for any individual. In yet another example, the duration of a flow event might be too long, e.g., 5 minutes. In other examples, any of these thresholds above may be compared to a typical value for the population to which the patient belonged. For example, if the patient is a 65-year-old Asian male with a history of hypertension and smoking, each processing element would compare its flow value to a urine flow value typical for a person with similar characteristics.

[0111] In operation 508, the server processing element 152 or the device processing element 252 determines whether the fluid temperature detected in the flow chamber 204 associated with the flow event is too high or too low compared to the threshold temperature value for urine. Operation 508 may be optional. For example, each processing element may compare the detected temperature to a characteristic urine temperature, i.e., a temperature corresponding to urination, such as gradually increasing over time and stabilizing at body temperature. The detected fluid temperature may be measured by a sensor in contact with the fluid in the flow chamber 204, or it may be estimated from a temperature sensor located elsewhere in the urination device 200 that does not directly contact the fluid, for example, a temperature sensor inside the handle 202. For example, if either processing element determines from the temperature sensor that the fluid in the flow chamber 204 was above 50°C, each processing element determines that this temperature is too high for fluid discharged from a human, and that the fluid was not urine discharged from a patient, but rather from rinsing the urination device 200. In another example, a processing element compares the fluid temperature in the flow chamber 204 to a typical body temperature of approximately 37°C and determines that the fluid is not urine if it deviates significantly above or below this typical temperature. The temperature value may be within a small window, and the temperature is only validated if it is neither too cold nor too warm. This range may be within 10°C to 15°C, which is typically the temperature range in which human urine is expected. In another example, fluid temperature data is recorded from a temperature sensor that is close to the urine flow but not in contact with the fluid. For example, a magnetic levitation sensor 262 may have a temperature sensor inside it. Such temperature data may tend towards body temperature (from ambient temperature) during the course of a flow event. The processing element may use this data as a signal that this event is indeed a urine event or urination event.

[0112] In operation 510, the server processing element 152 or the device processing element 252 determines whether the fluid flow data associated with a flow event falls within a specific boundary of urine by comparing the flow data with other thresholds. Operation 510 may be optional. In one example, each processing element compares the conductivity of the fluid in the flow chamber 204 with a urine threshold. For example, if the fluid has low conductivity, it may be distilled water or deionized water. In another example, if the fluid has very high conductivity, it may be saline. In yet another example, each processing element compares the opacity of the fluid in the flow chamber 204 with a urine threshold.

[0113] If the server processing element 152 or the device processing element 252 determines in one or more of operations 504, 506, 508, or 510 that the flow data associated with the flow event is not urination data, the method may proceed to operation 514, in which operation 514 the respective processing element discards the flow event data.

[0114] However, if the server processing element 152 or the device processing element 252 determines in one or more of operations 504, 506, 508, or 510 that the flow data is urination data (i.e., corresponds to a human urination event), the method may proceed to operation 512, in which each processing element determines that the flow event data is valid urination data and determines a valid urination profile 600. The method may terminate in operation 516.

[0115] Once the flow event data is authenticated, a processing element (in any of the urination device 200, server 112, user mobile device 108, healthcare provider device 109, reporting device 110, or third-party device 103) generates a urination profile. For example, the method 400 in Figure 4 may be applied to generate a urination profile and determine the relevant characteristics. Figures 6A and 6B illustrate examples of urination profiles 600. Each processing element may create a urination profile using the inlet flow of urine over time and the total urine volume accumulated over time. Examples of urination profiles can be seen in Figures 6A and 6B. Figure 6A illustrates an example of urine flow over time. Figure 6B illustrates an example of urine flow accumulated over time. As illustrated in Figure 6A, the urination profile 600 may have points and regions that can be detected by each processing element. For example, a point may be a single point in time. A region may span between two or more point in time. The urination profile is generated by plotting the flow rate measured over a time frame of the flow event for each processing element. In addition, the relationship between the measured volume and time may be plotted. The timestamps detected in method 400 can be used along with the measured values.

[0116] For example, a server processing element 152 or a device processing element 252 may detect the onset of urination 601 by, for example, detecting a change in the signal from a sensor. In one example, the device processing element 252 detects an increase in the output of a liquid level sensor 262, such as the displacement of a float 230, using a Hall effect sensor 222. In another example, the device processing element 252 detects a change in a conductivity sensor. For example, it detects an increase in conductivity between a pair of electrodes, which corresponds to the presence of a conductive fluid such as urine. In yet another example, the device processing element 252 detects a change in an opacity sensor. For example, it detects an increase in opacity, which corresponds to the presence of a liquid, or a decrease in transmitted light between a light transmitter and a light receiver. In yet another example, the device processing element 252 detects a change in the position of an incident ray on a photodetector, which results from a refractive index difference between air and water, urine, or some other liquid. For example, the light transmitter may be a light source such as a light-emitting diode, and the light receiver may be a light sensor such as a phototransistor or a cadmium sulfide photodetector, or other photodetector.

[0117] Generally, the voiding profile 600 may further have regions where urine flow increases. For example, the voiding profile 600 may have a region 602 where urine flow increases from a starting point 601 to a maximum value at point 603. Urine flow may decrease at point 603, but urine flow will vary depending on the specific patient.

[0118] The voiding profile 600 may further include regions where the urine flow decreases slowly. For example, the voiding profile 600 may include a region 604 where the urine flow decreases slightly over time from a maximum point 603, or where the urine flow remains substantially constant over time. The urine flow may be sustained within region 604 up to point 605, which is the beginning of the voiding termination region. At point 605, the rate of change of urine flow over time may begin to decrease in region 606 compared to region 604. In region 606, the urine flow may decrease up to point 607, where the urine flow substantially stops. Following the point where voiding stops, for example at point 607, the voiding profile 600 may include a further region 608. Region 608 may represent a delay while the voiding device 200 waits to determine whether voiding can be started again. Some urinary health problems involve intermittent voiding, in which the urine flow starts and stops multiple times within a single voiding event. Region 608 of the urination profile 600 will help the urination device 200 acquire urination data that matches such a problem. As described in operation 412 of method 400, the server processing element 152 or the device processing element 252 can numerically integrate the urine flow rate over time to create an accumulated urine profile, for example, profile 620.

[0119] Figure 7 is a flowchart illustrating a method 700 for determining a urination profile 600 and associated parameters. This method may be executed after a flow event has been authenticated as a valid urination event by a processing element in any of the following: the server 112, the urination device 200, the user mobile device 108, etc. In one example, a device processing element 252 sends valid or filtered urination data to the server 112 via the network 102, such as authenticated by method 500. Subsequently, the server processing element 152 executes method 700 to determine a urination profile 600 and associated parameters. Alternatively, in another example, the device processing element 252 of the urination device 200 executes part of method 700, and the server processing element 152 executes the rest. Various operations of method 700 may be executed by processing elements in any order in any combination of devices, including the urination device 200, the healthcare provider device 109, the server 112, the reporting device 110, the user mobile device 108, and / or the third-party device 103.

[0120] This method can be initiated from operation 702 when the server processing element 152 or the device processing element 252 receives authenticated urination data. The authenticated urination data corresponds to data collected by the urination device 200 (e.g., fluid level data, pitch and / or roll), which is authenticated by method 500 and corresponds to a urination event, rather than another type of flow event. The authenticated urination data may be received from the urination device 200, the server 112, the healthcare provider device 109, the third-party device 103, the user mobile device 108, the reporting device 110, or another device. The authenticated urination data may be received directly by the server processing element 152 from one or more of the other devices, or it may be received via the network 102. In one example, the authenticated urination data is a vector of data points of urine flow rate and a corresponding vector of associated time, stored in memory 154 by the server processing element 152. The server processing element 152 may repeatedly read and store the entire set of urination data or individual data points at various addresses in memory 154. In another example, the urination data also includes a vector of data points representing accumulated urine volume, related to a corresponding vector of time in relation to the relevant period. An abbreviated example of urination data for a particular urination event is shown in Table 2. Table 2 is not an example of all urination profiles, but is included as a means to illustrate the operation of method 700. A data point occupies a position within a data vector. The data vector has a start point at position 1 and an end point.

[0121] [Table 2]

[0122] It should be noted that although the operations of Method 700 are shown in a specific order, they can be performed in parallel, separately, and in any order as needed. In operation 704, the server processing element 152 or the device processing element 252 determines the peak urine flow rate. For example, the peak urine flow rate is point 603 in Figure 5. In one example, each processing element determines the peak urine flow rate by stepping through the data points of the authenticated urination data vector two at a time from the start to the end point and comparing them to determine which is larger. If the larger value is at the beginning of the vector, the positions of the two data points remain unchanged. However, if the smaller value is at the beginning, the positions of the two data points are swapped. This process is continued through the vector, and then repeated until the vector of data points is in descending order and the largest value is at the beginning. In another example, each time the data points themselves are swapped, the position of the data point and the associated time are swapped. This example yields a vector of data points sorted in descending order and a time vector containing the associated time sorted according to the corresponding data points.

[0123] In another example, the server processing element 152 steps through the data points of the authenticated urination data vector one at a time. The server processing element 152 copies the first data point to a buffer location in memory 154. The value in the buffer location may be referred to as the buffered flow value. The server processing element 152 may also store the time value associated with the buffered value in a second buffer location in memory 154. The value in the second buffer location may be referred to as the buffered time value. The server processing element 152 may then continue stepping through the second and subsequent values ​​of the authenticated urination data vector. The server processing element 152 compares the second value of the authenticated urination data vector with the buffered flow value. If the second value of the authenticated urination data vector is greater than the buffered flow value, the server processing element 152 copies the second value to the buffer in memory 154, overwriting the buffered flow value. The server processing element 152 may also store the time value associated with the newly buffered flow value in the second buffer location. However, if the second value is equal to or less than the buffered value, the buffered flow rate value and / or buffered time value are left unchanged. The server processing element 152 repeats this process over the authenticated urination data vector of flow rate data. Subsequently, the server processing element 152 retrieves the current buffered value, determines it to be the peak urine flow rate, and the operation ends. In the example in Table 2, the server processing element 152 determines the peak value of urine flow rate to be 2 mL / sec at position 4. Similar comparisons of other magnitudes can be performed using various methodologies, and the server processing element 152 analyzes the data to determine the peak.

[0124] In operation 708, the server processing element 152 or the device processing element 252 determines the cumulative urination volume. In one example, the authenticated urination data includes a vector of accumulated urine flow volumes (such as those determined in operation 412 of method 400 and authenticated by method 500), and the server processing element 152 performs the steps of operation 704 on the cumulative urine volume vector, rather than on the urine flow data as in operation 704. For example, the server processing element 152 sorts the cumulative urine volume data in descending order and determines that the first value in this sorted vector is the cumulative urine volume. In another example, the server processing element 152 steps through the cumulative urine volume data using a buffered value approach, as detailed in another example of operation 704, and determines that the buffered value at the end of the operation is the total cumulative urine volume. In the example in Table 2, the server processing element 152 determines that the cumulative urination volume is 26.516 mL produced in 8 seconds.

[0125] In operation 710, the server processing element 152 or the device processing element 252 determines the average urine flow rate. In one example, the server processing element 152 deletes or ignores data points in the authenticated urination data vector that are close to or equal to zero. In the example in Table 2, the server processing element 152 would ignore data points at positions 1, 7, and 8. The server processing element 152 then adds up the sum of all remaining data points for the urine flow rate of the authenticated urination data vector. The server processing element 152 then counts the number of remaining data points in the authenticated urination data vector. The server processing element 152 then divides the sum of the urine flow rate data by the number of data points. For example in Table 2, the server processing element 152 can determine that the sum of the remaining data points for the urine flow rate is 1 + 1 + 2 + 1.5 + 1 = 6.5 mL / sec. The number of data points in the urine flow rate vector is 5 (e.g., including data points 2-6). The server processing element 152 then determines that the average urine flow rate is 6.5 mL / sec / 5 = 1.3 mL / sec.

[0126] In another example of operation 710, the server processing element 152 determines the overall average urine flow rate without ignoring or discarding data points in the authenticated urination data vector that are close to or equal to zero. In the example in Table 2, the sum of all urine flow rate values ​​is 6.602 mL / sec. The number of points is 8. In that case, the average is 6.602 mL / sec / 8 = 0.825 mL / sec.

[0127] In operation 712, the server processing element 152 or the device processing element 252 determines the time to reach the maximum urine flow. In one example, the server processing element 152 determines the peak urine flow rate according to operation 704. While performing method 700, the server processing element 152 sorts the time values ​​associated with the urine flow rate while finding the peak urine flow rate. In this example, the server processing element 152 takes the first value of the sorted time vector and determines this to be the time to reach the peak urine flow rate. In another example, the server processing element 152 reads the buffered time values ​​from operation 704 and determines this to be the time to reach the peak urine flow rate. In the example in Table 2, the server processing element 152 determines the time to reach the peak urine flow rate to be 4 seconds, associated with a peak urine flow rate of 2 mL / second.

[0128] In operation 714, the server processing element 152 or the device processing element 252 determines the flow time or duration data of a flow event. For example, the server processing element 152 determines the first non-zero point in the authenticated urination data flow vector (for example, this is the point at position 2 in Table 2). The server processing element 152 then records the first non-zero flow and the associated time value in a first location in memory 154. The server processing element 152 then steps through the data points of the authenticated urination data flow vector one at a time to find the data point with the first zero value that follows the first non-zero data point. For example, the server processing element 152 compares the data points to determine whether they have decreased to zero or close to zero. If the server processing element 152 determines that a data point is zero or close to zero, the server processing element 152 may determine that this data point is the data point with the first zero value. The server processing element 152 then writes the data point with the first zero value and the associated time value to a second location in memory 154. Upon completion of the operation, the server processing element 152 determines the flow time by subtracting the time value of the second memory location from the time value of the first memory location. In another example, the server processing element 152 may apply filtering or other algorithms to prevent misidentification of either the first non-zero flow data point and / or the first zero value data point that follows the first non-zero flow data point. In the example in Table 2, the first non-zero flow data point is the point at location 2, with an associated time of 2 seconds. The data point that follows the first non-zero flow data point and has an associated time of 7 seconds. The difference between these associated times, i.e., the flow time, is 7 seconds - 2 seconds = 5 seconds.

[0129] In operation 716, the server processing element 152 or the device processing element 252 determines the urination time. In one example, the server processing element 152 reads the last time value from the time vector of authenticated urination data in memory 254 and determines that this is the urination time. In the example in Table 2, the urination time is 8 seconds. In another example, the server processing element 152 reads a flow time value, such as the result from operation 714, from memory 254, and determines the urination time by adding a predetermined time or a variable time to this flow time. For example, as in Table 2, if the flow time obtained from operation 714 is 7 seconds, the server processing element 152 may add a fixed time, for example 1 second, to the flow time and determine the urination time to be 8 seconds. Alternatively, the server processing element 152 may determine the timestamp of the last outflow value and determine that this is the end time.

[0130] This method can be terminated in operation 720, at which point the server processing element 152 or device processing element 252 records the urination profile characteristics in the urination log. The urination log may include information collected by the urination device 200, as well as information collected and manually recorded by the patient, healthcare provider, insurer, and / or third party. The urination log may reside in the memory storage of the urination device 200, the user mobile device 108, the server 112, the healthcare provider device 109, the reporting device 110, the third party device 103, or another device. In one example, the urination log may take the form of a database, for example, a relational database in which urination data, such as that determined by method 700, is stored as fields in various tables. As illustrated in Figure 11, in another example, the voiding diary provides an overview of data collected about the patient's urinary tract health, including information collected by the voiding device 200 (e.g., number of urinations, total and average voiding volume, maximum bladder capacity, minimum voiding volume, and percentage of daytime and nighttime urine output, including classification by whether they occurred during the day or at night). Also, as illustrated in Figure 11, the voiding diary includes information collected by the patient. For example, the voiding diary includes information about the patient, namely fluid intake, the number of times urinary incontinence ("UI") occurred, urinary urgency, behaviors preceding or related to UI (e.g., laughing, coughing, sneezing, sexual intercourse, lifting objects, or running), the amount of urine leakage, and the use of absorbent pads. In another example, the voiding diary inputs data to provide additional diagnostic and treatment response or performance information that provides the healthcare provider's skills and is considered and used in the analysis of the effectiveness of diagnosis or treatment. The data entered into the urination device may be sent back to server 112, for example from healthcare provider device 109, for recording, analysis, and reporting. Figure 20 shows another example of a urination diary over a three-day period. In the example of a urination diary illustrated in Figure 20, the diary is divided into day and night, and includes information such as total fluid intake, the amount of urine urinated over a 24-hour cycle, maximum, average, and minimum urination volumes, onset of incontinence, leakage, and pad use.Alternatively, in operation 720, each processing element may create a uroflow survey for a single voiding event, an example of which is illustrated in Figure 19. The survey may include information representing the data in Figures 6A and 6B, and may include voiding time, patient position (e.g., sitting, standing), urine volume, voiding time, flow time, time to reach maximum uroflow, mean uroflow rate, and an overall score for the voiding event. In one example, the survey may show an American Urological Association Symptom Index (AUA-SI) score to determine the overall severity of the patient's urological symptoms.

[0131] Figure 8 discloses a method 800 by which a processing element of a user mobile device 108 collects voiding diary data from a server 112 and / or from the patient. This method may be initiated in operation 802 when the patient launches an application on the user mobile device 108. The application may be any form of structured computer-executable code that can be executed by the processing element, or it may be interpreted code.

[0132] This method may proceed to operation 804, in which the processing element determines the type of urine event that has occurred, for example, through input from the user via the input / output interface of the user mobile device 108, through the application. A urine event can be any type of event related to the production or excretion of urine. In one example, the application asks the patient to choose from two types of urine events: urinating or drinking a beverage. In another example, the application asks the patient to choose from three types of urine events: urinating, drinking a beverage, or having a leak associated with the onset of a UI.

[0133] This method may then proceed to operation 806, in which the processing element determines whether the user indicated that the urine event was urination. In one example, the user mobile device 108 presents the user with a user interface, and the user then selects an event corresponding to a urination event. Urination is a urine event in which the user intentionally expels urine from their bladder. Leakage, on the other hand, is when urine is expelled from the user's bladder unintentionally, uncontrollably, or unconsciously. If the user indicates that the event was urination, the method may proceed to operation 808. If the event was not urination but rather the onset of a UI or fluid intake, the method may proceed to operation 818 or operation 820 in any order.

[0134] If the event is urination, the method may proceed to operation 808, in which the processing element scans server 112 for urination data, or requests or reads urination data from server 112. In another example, user mobile device 108 sends a data request to server 112, and server 112 then sends the requested data to user mobile device 108. Alternatively, the processing element requests or reads the relevant urination data from urination device 200. For example, server 112 or user mobile device 108 may connect directly to urination device 200 via either wireless or wired technology, and send queries to urination device 200 to determine whether it contains urination data. In some examples, the processing element of user mobile device 108 communicates with urination device 200 via Bluetooth®, Wi-Fi®, or short-range wireless communication. In other examples, the processing element communicates with urination device 200 via USB or other wired communication method. In yet another example, the processing element communicates with the urination device 200 via the network 102 using any combination of wired and wireless technologies.

[0135] If flow event data is available, the method may proceed to operation 810, in which the processing element receives urination profile characteristics or other urination data. In one example, the processing element receives urination profile characteristics from server 112. In another example, the processing element receives urination profile characteristics from the urination device 200 itself. The processing element may identify the urination profile characteristics and determine whether these urination profile characteristics are correct data derived from recent urination and not old data remaining in the memory 254 of the urination device 200. For example, the processing element may determine whether the urination data is recent by comparing one or more timestamps of the urination data with the current time. The processing element may identify the urination data using other methods, such as a serial number of the urination data, which may be unique. The processing element may receive the urination profile characteristics by any of the methods or techniques described above with respect to the urination device 200. Simultaneously with or after receiving the urination data, the processing element may store the urination data in memory storage 254. The method may then proceed to operations 812 or 814 in any order.

[0136] In operation 812, the application receives user-input urination data from the user regarding the urination event, for example via the user mobile device 108. For example, the application may display a screen for asking the patient why they chose to urinate and provide options or text inputs that the user can use to enter information. In one example, the application asks the patient whether the urination was due to convenience or urinary urgency. If the patient indicates that they urinated due to urinary urgency, the operation may proceed and the application may ask the patient about the severity of the urinary urgency. In one example, the application asks the patient to rate the urinary urgency as mild, moderate, or severe. The operation may proceed and the application asks the patient about any leakage associated with the urination event. In one example, the application asks the patient to rate the amount of leakage in the UI as none, dripping, wet, or soaked. The operation may proceed and the application asks the patient whether they themselves changed their leakage protection as a result of urination. In one example, the application asks the patient whether they made any changes themselves, or whether they changed their panty liners, light pads, heavy pads, or briefs.

[0137] This method may then proceed to operation 814, in which the application determines a time slot in the log for urination events. In one example, the application asks the patient if they have just woken up that day, and if the user answers yes, associates the urination data with the wake-up time. In another example, the application asks the user if they are going to bed for the night, and if the user answers yes, associates the urination data with the bedtime. In yet another example, the application asks the user if they woke up at night due to urinary urgency.

[0138] The process may then proceed to operation 816, in which the processing element associates the log data with the user's urination log. The processing element may upload the log data to a urination log stored in the memory of the urination device 200, the user mobile device 108, the server 112, the healthcare provider device 109, the third-party device 103, or another device. The processing element may perform this upload using any combination of the communication methods and technologies already disclosed for connecting these devices. Furthermore, the processing element associates the log data collected from both the user and the urination device 200 with a specific log associated with that user. The processing element may display the urination log or urination data from the urination device 200, the user mobile device 108, the server 112, the healthcare provider device 109, the third-party device 103, or another device.

[0139] If in operation 806 it is determined that the event is not a urination event, or if the user indicates in operation 806 that the urine event was not urination but rather the onset of a UI or fluid intake, the method may proceed to operation 818.

[0140] The method may proceed to operation 818, in which the processing element receives information about the user's fluid intake via the application. In one example, the application presents the user with a series of graphical representations of beverages of various sizes (e.g., a cup (small), a can (medium), or a bottle (large)). The application may prompt the user to input the volume of fluid they have consumed. In one example, the application may prompt the user to input the number of fluid ounces they have consumed.

[0141] This method may optionally proceed to operation 820, in which the processing element, via the application, questions the user about urinary leakage. In various examples, the application questions the user about the number of times the user has experienced urinary leakage, urinary urgency, actions preceding or related to the urinary leakage (e.g., laughing, coughing, sneezing, sexual intercourse, lifting an object, or running), the amount of urinary leakage, and the use or modification of an absorbent pad.

[0142] Figures 16A to 16E are flowcharts illustrating specific implementations of the method in Figure 8. Figures 16A to 16E are examples of specific implementations and are not intended to limit the method 800 in any way. As illustrated in Figure 16A, the user mobile device 108 runs an application that starts with a splash screen welcoming the user. The application then proceeds to screens to ask the user about specific urination events such as beverage intake, suppressed urination events, and UI events or leaks. If the user selects "I drank a beverage," the application then asks about the size of the beverage. Figure 16E illustrates a sample of user interface graphics regarding beverage intake. If the user selects "I went to the toilet," the application prompts the user to scan the server 112 for authenticated urination data. If authenticated urination data is found, the application proceeds to node B, as illustrated in Figure 16C, where it asks the user why they urinated, for example, the level of urinary urgency, whether it was due to convenience, the level of leakage in the UI, and any changes to their leakage protection. The application also asks the user whether they are getting up that day or whether they went to the toilet at night due to urinary urgency, as illustrated in node A of Figure 16A. If the user selects "I had an incontinence," the application proceeds to node D of Figure 16D, where the user is asked about the extent of the incontinence, such as actions associated with the incontinence, such as running, lifting objects, laughing, or sexual intercourse, and any changes to their leakage protection. The application may also display a help screen, as illustrated in Figure 16B.

[0143] As described above, the urination device 200 and the urination data can be used to collect and analyze therapeutic urinary data. Figure 9 discloses a method 900 for analyzing data on a patient's urinary tract health using the urination device 200. This method may be performed in one or more of the following devices: healthcare provider device 109, reporting device 110, server 112, third-party device 103, user mobile device 108, or other preferred devices.

[0144] This method may begin with operation 902, in which the processing element receives patient data from one or more of the following: urination device 200, server 112, healthcare provider device 109, reporting device 110, or third-party device 103. The processing element may reside within the urination device 200, reporting device 110, healthcare provider device 109, third-party device 103, server 112, or another device. Each processing element may receive patient data from another device via network 102, or from manual input, during or after the patient examination or interview. In one example, a physician or other healthcare provider manually enters patient information into a healthcare provider device 109, such as a computer, tablet, mobile phone, or other computing device. The patient data may include height, weight, age, name, or other patient identifiers, or similar data corresponding to the patient. The types of patient data may be changed as needed, but are generally intended to identify a particular patient from among multiple patients.

[0145] This method may proceed to operation 904, in which the healthcare provider assigns a urination device 200 to a patient for use and associates a specific urination device 200 with a specific patient, or creates a link between them. The urination device 200 may have a device identifier, which may be unique. Optionally, different parts of the urination device 200 may have different device identifiers. For example, the handle 202 may have one device identifier, and the flow chamber 204 may have another. The device identifier may associate the handle 202 with the flow chamber 204, as well as with a patient. In one example, the unique device identifier may be a serial number, barcode, image, etc., and the urination device 200 can be tracked to determine which patient it is associated with, and can be unassociated from one patient and associated with another. In one example, the device identifier may be associated with a detachable, disposable flow chamber 204 attached to the handle 202. A new disposable flow chamber 204 may be associated with the handle 202 for each patient using the urination device 200. The flow chamber 204 may include an RFID element that stores a device identifier. To ensure that the flow chamber 204 is used for only one patient, the device identifier stored in the RFID element may be read.

[0146] Furthermore, a patient may have a unique patient identifier. In one example, the unique patient identifier may be a patient number or the patient's name and date of birth. In one example, to associate the urination device 200 with a patient, the healthcare provider causes a processing element in the healthcare provider device 109 to create a record in memory linking the patient's unique identifier to the unique identifier of the urination device 200. This record may be transmitted to the server 112 or other devices in the information management system 100. In another example, each processing element generates a confirmation screen to verify the link between the patient identifier and the device identifier.

[0147] This method may proceed to operation 906, in which case the voiding diary is activated or associated with a specific patient. In one example, the healthcare provider device 109 associates the voiding device 200 with a patient. In one example, the voiding diary is a database stored in the memory of the healthcare provider device 109, the user mobile device 108, and / or the server 112, and contains records of the patient's urinary health status. The voiding diary contains records of associations between the patient and the voiding device 200, such as results from operation 904.

[0148] This method may proceed to operation 908, in which each processing element receives voiding diary data corresponding to a user's urination or urine event, such as input from method 800 in Figure 8. Each processing element may receive diary data via network 102 from one or more of the following: voiding device 200, reporting device 110, healthcare provider device 109, third-party device 103, server 112, or another device. Alternatively, each processing element may receive voiding diary data directly from one of the above devices. In one example, healthcare provider device 109 is a tablet or other portable computer that communicates with user mobile device 108 via network 102. User mobile device 108, such as a smartphone, may communicate with both healthcare provider device 109 and voiding device 200. In one example, user mobile device 108 transmits voiding diary data to healthcare provider device 109 via a Wi-Fi® network connection. In another example, voiding device 200 transmits voiding diary data via a private cellular network. In one example, the user mobile device 108 sends urination diary data to the server 112, which is communicating with the healthcare provider device 109, and thereby receives the urination diary data from the server 112.

[0149] As illustrated in Figure 8, the voiding diary data corresponds to urine and urination events, as well as patient input information such as the patient's emotions and intake. This method may proceed to operation 910, in which each processing element may select and access a specific voiding diary. In one example, each processing element displays a user interface on a tablet computer, and after the physician provides security authentication, selects and accesses one diary from a variety of available voiding diaries. In another example, each processing element sends an alert to the physician informing them that new voiding diary information is available and provides links, such as hyperlinks, for the physician to follow, enabling access to the voiding diaries.

[0150] This method may proceed to operation 912, in which each processing element outputs voiding diary data or a urinary health report, including information collected by the voiding device 200 and / or information collected by the patient, relating to the patient's urinary health. Figure 11 illustrates an example of a voiding diary report. The voiding diary report may be displayed on a user mobile device 108, a healthcare provider device 109, or other device. In this example, voiding data for one patient over three days, day and night, is displayed. The voiding data shown in this example includes daily data for urination frequency, urine volume, fluid intake, and number of UI events, as well as daily average values ​​for urine output, fluid intake, maximum bladder capacity, voiding frequency, average urine volume, minimum urine volume, and the number of UI events per day and night. This example also shows data on UI events, such as urinary urgency, behaviors that trigger UI events, amount of urine leakage, and use of absorbent pads. The urination log includes user inputs received by the user from the input / output of the user mobile device 108, inputs received from the healthcare provider device 109, and urination data collected from the urination device 200. For example, the log in Figure 11 includes not only urination data from the urination device 200 such as urine volume, frequency of urination, and maximum bladder capacity, but also user emotions such as urinary urgency.

[0151] The method may proceed to operation 914, in which each processing element waits for a specified time for the patient to use the voiding device 200 and / or to keep a voiding diary. During this operation, additional voiding diary data may be accumulated, and the method may return to any of operations 902-910 as needed.

[0152] This method may proceed to operation 916, in which each processing element may cause a healthcare provider or another person to disassociate the urination device 200 with a particular patient, thereby severing, discarding, or deactivating the association that was established between the patient and the urination device 200 in operation 904. After the association is deactivated, the server 112 may maintain a record of the patient who used the particular urination device 200, and / or the urination device 200 associated with the particular patient. Disassociating may also trigger the generation of a report by the processing elements of one or more devices. Subsequently, all or part of the urination device 200 may be returned to the healthcare provider. The healthcare provider or medical device service provider cleans, disinfects, and recharges the device for further use by another patient. The healthcare provider may use a custom tool or key to detach part of the device (e.g., as shown in Figures 20 and 2P), discard part of the device, and preserve durable parts for reuse. In one example, the healthcare provider discards the flow chamber 204 and stores the handle 202 of the urination device 200 for further use. In one example, a device identifier may be read from an RFID element in the flow chamber 204 to ensure that a particular device identifier is no longer associated with a patient and that the flow chamber 204 is used by only one patient and not reassigned to any new patient. The flow chamber 204 is detached from the handle 202 and discarded. A new flow chamber 204 with a new device identifier may be associated with the handle 202. The new device identifier may be stored in an RFID element in the flow chamber 204. This method may end in operation 920.

[0153] Figures 17A–17E are flowcharts illustrating specific implementations of the method of Figure 9, which may be implemented as applications on a tablet or other computer. Figures 17A–17E are examples of specific implementations and are not intended to limit the scope of Method 900. As illustrated in Figure 17A, the application starts with a splash screen and proceeds to node A, where the user is given options to start a new patient survey, view an existing test report, return the device to unassociate it with the patient, or access the settings menu. The application includes provisions for the user to authenticate themselves. Node B in Figure 17A illustrates various screens in the application where the user can input information about the new survey, including patient information, the type of survey to be completed, and whether the patient has a smartphone. As illustrated in Figure 17B, the screen progresses so that the user can associate the flow chamber 204 with the handle 202, scan the assembled device, and associate this assembled urination device 200 with the patient. If the association between the urination device 200 and the patient is successful, the application proceeds to node B8 in Figure 17C to complete the setup of the new study. If the user chooses to view the report from the start screen, the application proceeds to node C in Figure 17D, then to node C1 in Figure 17E, where the user authenticates themselves and can then view the urination diary report for the patient. If the user chooses to return the device from the start screen, the application proceeds to node D in Figure 17D and node D1 in Figure 17E. Here, the user is prompted to scan the device to be returned and receives a notification if the scan is successful. If the user chooses to enter the settings screen from the start screen, the user may enter the settings screen as shown, for example, in Figure 17D.

[0154] Figure 10 discloses a method 1000 in which a processing element receives pre-treatment and post-treatment voiding diary information in order to evaluate the effectiveness of treatment and the payment of treatment. The processing element may be located in a voiding device 200, a reporting device 110, a healthcare provider device 109, a third-party device 103, a server 112, or another device. The ability to compare information may help healthcare providers select the best course of action for treatment and may also establish criteria for symptoms that insurance companies and / or healthcare providers can use to evaluate the effectiveness of treatment. Examples of reports generated by the disclosed system are illustrated in Figures 21 and 22, which show patient uroflowmetry and voiding diary information over several months.

[0155] This method may be initiated in operation 1002, in which pre-treatment voiding diary information is received by the respective processing elements of the reporting device 110 or the healthcare provider device 109. The voiding diary information may be collected by the method and by the devices described above. In one example, a healthcare provider prescribes a voiding device 200 to a patient seeking treatment for UI symptoms and asks the patient to keep a voiding diary using the voiding device 200 before any treatment is initiated. The patient then collects voiding diary information as disclosed. The server 112 may make the report or voiding diary available to the reporting device 110 and / or the healthcare provider device 109. In one example, the server may provide a link to the report or voiding diary. In another example, the server 112 may send a copy of the report or voiding diary. In one example, a pre-treatment voiding diary 2200 is illustrated in Figure 22. Alternatively, a pre-treatment uroflowmetry 2100, illustrated in Figure 21, for example, may be received.

[0156] This method may proceed to operation 1004, in which the patient receives treatment for UI symptoms and / or causes and collects post-treatment voiding diary information received by the respective processing elements. In one example, the patient collects voiding diary information using a voiding device 200 and a user mobile device 108. The patient transmits the post-treatment voiding diary information to a server 112, a healthcare provider device 109, a reporting device 110, or other device according to the disclosed method. For example, the patient may use a voiding device 200 as disclosed, and the voiding device 200 may transmit the voiding diary information to a server 112, a healthcare provider device 109, a reporting device 110, or other device. In various examples, post-treatment uroflowmetries 2102, 2104 and post-treatment voiding diaries 2202, 2204 may be generated, as illustrated in Figures 21 and 22.

[0157] This method may proceed to operation 1006, in which each processing element analyzes pre- and post-treatment voiding diaries and / or uroflowmetries to provide comparative information for determining the effectiveness of the treatment. In one example, each processing element produces a report, e.g., Figure 21 or Figure 22, showing changes in the number of UI occurrences, changes in leakage volume, urinary urgency, urine volume, uroflowmetry, and other data related to post-treatment health status, enabling healthcare providers and insurance companies to make decisions about the effectiveness of the treatment.

[0158] This method may proceed to operation 1008, in which each processing element ranks the effectiveness of different treatments based on the improvement of UI symptoms after treatment. For example, each processing element aggregates anonymized patient data, including post-treatment outcomes. Each processing element further categorizes the outcomes according to patient demographic data such as weight, age, sex, and ethnicity, and further categorizes the data according to the treatment used. Each processing element may then rank the most effective treatment for the entire population of patient records, or provide a ranking for a subset of the population. For example, each processing element may determine that treatment with drug "A" is most effective for women aged 50 and over, while treatment with drug "B" is most effective for men aged 50 and over. This method terminates in operation 1010.

[0159] Figure 15 illustrates an example of a typical use 1500 of the urination device 200. This method may begin in operation 1502 when the patient picks up the urination device 200. In operation 1504, the urination device 200 senses movement, for example, by the verification sensor 260, or senses the patient's grasp by the power button 279 and / or touch sensor. In operation 1504, the urination device 200 begins recording sensor data such as data from the verification sensor 260, liquid level data, and / or temperature, conductivity, opacity, or other data. In operation 1506, the patient urinates into the urination device 200. In operation 1508, the patient puts down the urination device 200. In operation 1510, the urination device 200 stops recording sensor data. In operation 1512, the urination device 200 communicates with the server 112 and transmits flow event data. In operation 1514, the server 112 either authenticates the flow data as authenticated urination data, or discards the flow data if it is not authenticated urination data.

[0160] The above specification, examples, and data provide a complete description of the structure and use of exemplary embodiments of the present invention as defined in the claims. While various embodiments of this disclosure have been described above with some degree of specificity, or by reference to one or more embodiments, those skilled in the art will be able to make numerous modifications to the disclosed embodiments without departing from the spirit or scope of the claimed invention. Therefore, other embodiments are also to be considered. All matters included in the above description and shown in the accompanying drawings are intended to be interpreted as merely illustrative of particular embodiments and not limiting. Modifications of detail or structure may be made without departing from the fundamental elements of the invention as defined in the following claims.

[0161] All relative and directional references (including up, down, upward, downward, left, right, leftward, rightward, top, bottom, side, top, bottom, front, center, rear, vertical, horizontal, correct up and down, up and down, sideways, etc.) are provided as examples to aid the reader's understanding of the specific examples described herein. They should not be read as requirements or limitations, particularly regarding position, direction, or use, unless otherwise stated in the claims. References to connections (e.g., attached, joined, connected, linked, etc.) should be interpreted broadly, and connections between elements may include intermediate members and may include relative movement between elements. Thus, references to connections do not necessarily mean that two elements are directly connected or in a fixed relationship with one another, unless otherwise stated in the claims.

Claims

1. A method for authenticating flow events detected by a handheld urination device as equivalent to urine events, Computers During the aforementioned flow event, the flow characteristics of the fluid flow through the urination device are received from the liquid level sensor and the verification sensor. Based on the received flow characteristics, it is determined that the flow event corresponds to a urine event. Send unanalyzed data regarding the aforementioned urinary events to the server, and Outputting a urination profile corresponding to the aforementioned flow event, This includes performing the following: The liquid level sensor includes a float, a magnet, and a displacement sensor for detecting changes in the position of the magnet, wherein the magnet is rotatably coupled to the float via an arm, the float is positionable according to a plurality of liquid levels, the float and the arm rotate around a pivot axis according to the plurality of liquid levels, and the magnet connected to the arm rotates around the pivot axis. Computer implementation method.

2. Analyzing one or more detected characteristics is The direction of the detected liquid level sensor is compared with the location of the urine event, and it is determined that the detected direction is valid. The detected fluid flow rate is compared with the flow rate of a characteristic urine event, and it is determined that the detected flow rate is effective. The detected temperature is compared with a characteristic urine temperature to determine that the detected temperature is valid. The method according to claim 1, comprising at least one of the following.

3. The direction value of the urination device is received from the verification sensor, and Based on the aforementioned directional value, it is determined that the flow event corresponds to a urine event. The method according to claim 1, further comprising:

4. A system for evaluating the urinary tract health status of patients, A handheld urination device comprising a liquid level sensor, a float, a magnet, and a displacement sensor for detecting changes in the position of the magnet, wherein the magnet is rotatably coupled to the float via an arm, a device processing element, and a flow chamber, which receives patient urine, and the device processing element receives multiple outputs of the liquid level sensor corresponding to multiple liquid level levels of fluid flowing through the device during a flow event, the float is positionable according to the multiple liquid level levels, the float and the arm rotate around a pivot axis according to the multiple liquid level levels, and the magnet connected to the arm rotates around the pivot axis, A server that communicates with the aforementioned handheld urination device, receives flow event data from the urination device, analyzes the flow event data using a server processing element to authenticate the urination event, determines parameters related to the authenticated urination event, associates the parameters with a urination diary stored in memory, and outputs a report on the health status of the urinary tract. A healthcare provider device that communicates with the server, and the healthcare provider device that receives a report from the server regarding the health status of the urinary tract, A system that includes this.

5. The system according to claim 4, further comprising a charging station that communicates with the interface of the urination device.

6. The system according to claim 5, wherein the device processing element receives firmware via the interface.

7. The system according to claim 5, wherein the device processing element determines the state of the handheld urination device, receives information from the charging station via the interface, and indicates through an indicator that it is ready for continuous use.

8. The system according to claim 4, wherein the handheld urination device further includes a GPS assembly that communicates with the device processing element, the device processing element determining the relative position of the urination device.

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