Urinalysis Devices and Related Methods
20210074390 ยท 2021-03-11
Inventors
Cpc classification
G06K7/10297
PHYSICS
G16H50/20
PHYSICS
G16H10/60
PHYSICS
A61B5/0002
HUMAN NECESSITIES
G16H10/40
PHYSICS
International classification
G16H10/40
PHYSICS
G06K7/10
PHYSICS
Abstract
This disclosure relates to method that comprises sensing properties of a urine sample of a patient using a biomarker sensor to generate raw urine data. The method further includes transmitting the raw urine data to a processor, using the processor to generate processed urine data from the raw urine data, and transmitting the processed urine data to a computing device.
Claims
1. A method comprising: sensing properties of a urine sample of a patient using a biomarker sensor to generate raw urine data; transmitting the raw urine data to a processor, using the processor to generate processed urine data from the raw urine data, and transmitting the processed urine data to a computing device.
2. The method according to claim 1, further comprising suggesting one or more adjustments to a treatment plan based on the processed urine data.
3. The method according to claim 2, wherein the treatment plan is at least one of a nutrition plan, a medication prescription, and a blood treatment prescription.
4. The method according to claim 1, wherein the processed urine data comprises a packet of urine data that contains levels and concentrations of the sensed properties in the urine sample.
5. The method according to claim 1, further comprising sensing a patient identification, generating patient identification data, and transmitting the patient identification data to the processor.
6. The method according to claim 5, further comprising comparing the transmitted patient identification data to predetermined patient identification data and determining a patient identification.
7. The method according to claim 6, further comprising linking the processed urine data to the patient identification.
8. The method according to claim 5, further comprising linking the transmitted raw urine data to the transmitted patient identification data.
9. The method according to claim 5, wherein sensing the patient identification comprises sensing a fingerprint using a fingerprint reader.
10. The method according to claim 5, wherein sensing the patient identification comprises sensing an RFID tag using an RFID detector.
11. The method according to claim 1, wherein transmitting the raw urine data to the processor comprises: transmitting the raw urine data using a signal transmitter of a urinalysis device, receiving the raw urine data using a signal receiver of an intermediate device, and transmitting the raw urine data to the processor using a signal transmitter of the intermediate device.
12. The method according to claim 11, wherein the intermediate device is a mobile computing device.
13. The method according to claim 12, wherein the mobile computing device is a mobile phone or a tablet.
14. The method according to claim 1, further comprising using the processor to adjust parameters of a blood treatment prescription based on the processed urine data.
15. The method according to claim 14, further comprising transmitting the blood treatment prescription with the adjusted parameters to a blood treatment machine.
16. The method according to claim 14, wherein the processed urine data comprises at least one of specific gravity, pH, uric acid levels, glucose levels, fat levels, proteins levels, fiber levels, nitrite levels, sodium levels, potassium levels, calcium levels, and phosphate levels.
17. The method according to claim 1, further comprising generating a report based on the processed urine data.
18. The method according to claim 17, wherein the report identifies properties of the urine sample that are outside a predetermined range.
19. The method according to claim 17, further comprising determining a diet of a patient based on the processed urine data, wherein the report identifies the diet of the patient.
20. The method according to claim 17, further comprising transmitting the report to a medical professional.
21. The method according to claim 17, further comprising transmitting the report to a patient.
22. A urinalysis device comprising: a body configured to be connected to a toilet, a biomarker sensor attached to a portion of the body configured to be submerged in water in the toilet when the body is connected to the toilet, the biomarker sensor configured to detect properties of urine and to generate raw urine data comprising the detected properties of the urine, and a signal transmitter configured to transmit the raw urine data to a processing device.
23.-39. (canceled)
30. A system comprising: a urinalysis device comprising: a body configured to be connected to a toilet, a biomarker sensor attached to a portion of the body configured to be submerged in water in the toilet when the body is connected to the toilet, the biomarker sensor configured to detect properties of urine and to generate raw urine data comprising the detected properties of the urine, and a signal transmitter configured to transmit the raw urine data; and a processing device comprising: a signal receiver configured to receive the raw urine data from the signal transmitter of the urinalysis device, a processor configured to process the raw urine data and generate processed urine data from the raw urine data, and a memory for storing the processed urine data.
31.-37. (canceled)
Description
BRIEF DESCRIPTION OF FIGURES
[0050]
[0051]
[0052]
[0053]
[0054]
DETAILED DESCRIPTION
[0055]
[0056]
[0057] The biomarker sensor 117, which is schematically illustrated in
[0058] As shown in
[0059] Referring again to
[0060] Still referring to
[0061] In some implementations, the urinalysis device is calibrated by taking the combined measurements of the water temperature, water volume or level, specific gravity, pH, uric acid levels, glucose levels, fat levels, proteins levels, fiber levels, nitrite levels, sodium levels, potassium levels, calcium levels, and phosphate levels in the water. These measurements can be taken at regular intervals, such as every 30 seconds, 1 minute, 5 minutes, 30 minutes, or 1 hour. This calibration data is used as the baseline or zero measurement for the subsequent sample measurements. When urine is added, concentrations will change.
[0062] The water level sensor 118 can be any of various type of suitable level sensors, including electrodes, mechanical float switches, optical sensors, capacitance sensors, and ultrasonic sensors. The temperature sensor 119 can be any of various suitable sensors capable of detecting water temperature.
[0063] A finger print reader 109, as shown in
[0064] A signal transmitter 107 is attached to the arm 124 of the body 111. The signal transmitter 107 can be any of various commercially available transmitters capable of being electronically connected to the wire 103, the biomarker sensor 117, and the water sensor 118. The signal transmitter 107 can be used to transmit the raw urine data 113 and the raw patient data 115 to the server 104, as schematically illustrated in
[0065] A status light 122 is used to indicate an action or alert. The status light 122 can, for example, be configured to blink green to indicate that the sensor 117 is measuring, to be solidly green to indicate that the device 102 is calibrated, to blink red to indicate that raw urine and patient data 113, 115 is being transmitted, and to be solidly red to indicate that the transmission of the raw urine and patient data 113, 115 is complete.
[0066] Referring again to
[0067] The signal receiver 106 also receives raw patient identification (ID) data 115 from the signal transmitter 107 of the urinalysis device 102. The processor 108, the controller 110, and the memory 112 of the server 104 compare and tag the raw patient ID data 115 with a patient ID stored in the memory 112. The memory 112 includes a data set of predetermined patient ID data. The controller 110 and the processor 108 compare the predetermined patient ID data to the raw patient ID data 115. When the predetermined patient ID data in the memory 112 matches the raw patient ID data 115, the raw patient ID data 115 is tagged with the corresponding predetermined ID data (matched patient ID). When the predetermined ID data in the memory 112 does not match the raw patient ID data 115, the raw patient ID data 115 is tagged as an unknown person (unmatched patient ID).
[0068] The most recent raw urine data 113 received by the server 104 is then tagged with the patient ID now associated with the raw patient ID data 115. At this step, the raw urine data 113 and the raw patient ID data 115 are tagged by the same patient ID. The data 113, 115 is then saved in the memory 112 of the server 104 under a folder associated with the patient ID.
[0069] When the patient ID is an unmatched patient ID, the data 113, 115 is saved with other data 113, 115 tagged as an unknown patient. In some cases, the data 113, 115 tagged as an unknown person is automatically deleted after a predetermined period of time (e.g., one hour, one day, one week, one month, one year, etc.), assuming no valid patient ID associated with that data is saved in the server 104 before that time period expires. In other cases, the data 113, 115 determined to be associated with an unknown person is automatically deleted immediately upon making that determination.
[0070] The processor 108 processes the raw urine data 113 and inputs the most recent levels of components (the processed data) in the urine into a folder associated with the patient ID. This occurs for both matched patient IDs and unmatched patient IDs. To process the raw urine data 113, the processor 108 runs the set of default software scripts, analyzes the raw urine data 113, and identifies key markers or patterns in the raw urine data. The set of default software scripts are initially chosen by the clinician during the program setup in the medical facility. Once the processor 108 analyzes the raw urine data 113 using the set of default scripts, the processor 108 outputs processed urine data.
[0071] The memory 112 of the server 104 saves the processed data under the folder associated with the patient ID. If the patient ID is a matched patient ID, the controller generates a packet of data that includes processed urine data associated with a patient ID data. The controller 110 of the server 104 generates a report from the packet of data related to the levels of components measured in the urine. These reports are transmitted to the patient's computer 130 and/or to the medical professional's computer 132. These reports can be viewed by the patient, physician, and/or nutritionist and used to adjust the patient's treatment plan (e.g., the patient's recommended diet, prescribed medication(s), and/or recommended blood treatment parameters).
[0072] As noted above, if the patient ID is an unmatched patient ID (unknown patient), the processed urine data, the raw urine data, and the raw patient ID data is saved under the finder associated with unknown patients. The controller 110 deletes the data accompanied with an unmatched patient ID after a given period time. Prior to the deletion of this data, a user with access to the server 104 may review the folder containing the unmatched patient IDs and the associated data. If the user determines that the urine data belongs to a known patient, the user can manually retag the data and can move the data to the proper folder of a known patient ID.
[0073] A method of using the system 100 illustrated in
[0074] After installing the urinalysis device 102, the urinalysis device 102 is automatically calibrated on a regular basis to generate baseline data. The urinalysis device 102 can, for example, be calibrated every 30 seconds, one minute, 30 minutes, one hour, etc. As discussed above, the urinalysis device 102 can be calibrated based on the detected level and composition of the water in the toilet 116 prior to introducing urine into the toilet 116. More specifically, the biomarker sensor 117 detects the initial levels of pH and other water properties to create a base line. The water level sensor 118 and the temperature sensor 119 detect the amount of water in the toilet 116 and the temperature of that water. After the calibration process is complete, the status light 122 emits a solid green light to indicate that the device is calibrated and ready to test a urine sample.
[0075]
[0076] Once the measurement is complete, the user places a finger on the fingerprint reader 109 (e.g., to flush the toilet). The finger print reader 109 scans the finger print and generates raw patient ID data. The raw patient ID data 115 is transmitted 144 to the signal receiver 106 of the server 104. The status 122 light blinks red to indicate that the data is being transmitted and is solidly red once the data has been successfully transmitted. Advantageously, the finger print reader 109 can automatically scan the patient's finger print as the patient flushes the toilet such that no additional steps beyond those typically involved with using a toilet are required.
[0077] Flushing of the toilet 116 cleans the biomarker sensor 117. Once fresh water fills the toilet bowl, the urinalysis device 102 recalibrates so it will be ready for a subsequent use.
[0078] The signal transmitter 107 then transmits the raw urine data 113 and the raw patient ID data 115 to the signal receiver 106 of the server 104 (144). Transmission of the data 113, 115 to the server 104 can be triggered by the finger print reader 109 detecting a finger print. Alternatively, transmission the data 113, 115 can be triggered in other ways, such as by the water level sensor 118 detecting a significant drop in the water level indicating that the toilet 116 has been flushed.
[0079] The processor 108, the controller 110, and the memory 112 of the server 104 are then used to analyze the data 113, 115 (146). The processor 108, the controller 110, and the memory 112 of the server 104 process, compare, and tag the raw patient ID data 115 with a patient ID stored in the memory 112. The memory 112 includes a data set of predetermined patient ID data that are each associated with a patient ID. The controller 110 and the processor 108 compare the predetermined patient ID data to the raw patient ID data 115. When the predetermined patient ID data in the memory 112 matches the raw ID data 115, the raw patient ID data 115 is tagged with the patient ID associated with the predetermined patient ID data. The most recent raw urine data 113 received by the server 104 is also tagged with the patient ID associated with the predetermined patient ID data to associate the urine data with the known patient.
[0080] The processor 108 in the server 104 then processes the raw urine data 113 to determine levels and concentrations of components in the urine of the patient which are indicative of patient diet and/or health 146. The raw urine data 113 is processed using the set of default software scripts chosen during the initial setup of the program in the medical facility. The processor 108 in the server 104 generates a packet of processed urine data 148 that contains levels and concentrations of the detected properties in the urine sample. This packet of data is analyzed and a report is generated 150 based on the packet of urine data. The report can identify properties of the urine that are outside a predetermined range. The report can also estimate a diet of the patient based on the packet of data and can thus allow the patient and his or her physician to determine how closely the patient has been adhering to a recommended diet. In some cases, the report includes suggested adjustments to the patient's treatment plan. The report can, for example, recommend adjustments to the patient's diet, recommend adjustments to the patient's medication(s) or medication dosage(s), or recommend adjustments to blood treatment parameters for an upcoming blood treatment.
[0081] The report is transmitted to a medical professional's computer 132 and/or to the patient's computer 130. At a patient's next appointment, the medical professional may review the report and adjust the treatment plan as needed. For example, if uric acid levels are higher than expected, a medical professional may adjust medication dosages. Or if potassium levels are low, a medical professional may recommend increasing potassium-rich foods in the patient's diet like bananas or prescribe potassium supplements.
[0082] For patients who are receiving blood treatments (e.g., dialysis treatments), the report can be used by the medical professional to determine an appropriate blood treatment (e.g., dialysis) prescription. For example, if the patient is determined to be overly hydrated, which can be determined based on the detected specific gravity and/or ion concentration levels, the blood treatment prescription may be adjusted to increase the ultrafiltration volume. The report can also suggest a specific concentration of dialysate to be used for the patient based on the detected properties of the patient's urine (e.g., based on molecular levels of nitrate, sodium, potassium, calcium, and/or phosphate in the patient's urine).
[0083] For patients who are not yet receiving blood treatments (e.g., dialysis treatments), the report can be used by the medical professional to determine when blood treatments may become necessary for those patients.
[0084] Thus, the processed urine data can be used by the patient and his or her physician to improve a number of different aspects of the patient's treatment plan and can be used for patients in various different stages of kidney disease.
[0085]
[0086] While urinalysis devices 102, 160 with fingerprint readers have been previously described, the urinalysis device may instead include a radio-frequency identification (RFID) to confirm patient identification. RFID is a wireless technology that uses radio waves to transfer data from a RFID tag, an electronic tag attached to an object, for the purpose of identifying the object. For example, a RFID tag might be attached to a patient's phone or watch and uniquely identify that patient. When the patient uses the urinalysis devices 102, 160, the RFID tag can be identified and a patient's identity tagged to the urinalysis data detected. Other biometric sensors to confirm the patient ID, such as iris/retina scans, heat signatures, or voice recognition can alternatively or additionally be used.
[0087] In some implementations, a patient ID code is entered into the system by the patient to associate the tested urine with that patient. For example, the urinalysis device may be connected to a keypad that is mounted to the toilet. The system provides the patient with a unique patient ID code, for example 012345, that is entered directly before providing a sample or directly after providing a sample. Alternatively the patient may program a patient ID code when setting up the device for the first time, either on the device or on a website. The patient ID code is linked to a patient profile in a remote server. The patient profile includes urinalysis data taken by the urinalysis device, or any other urinalysis device compatible or connected to the remote server. Other information can also be stored in the patient profile, for example, manually entered urinalysis data, blood treatment prescriptions, treatment history, and other data relevant to blood treatment. Once the urinalysis device has detected and measured the sample, raw urine data is generated. The urinalysis device transmits raw urine data to the remote server if a patient ID code has been entered within a predetermined amount of time of a detected sample, for example within 3 minutes of detecting and measuring a sample. Otherwise the raw urine data is deleted. The transmitted raw urine data is tagged with the manually entered patient ID code. The remote server receives the tagged raw urine ID and sorts the raw urine ID into the patient profile associated with the patient ID code.
[0088] Some urinalysis devices may confirm the patient ID prior to send the raw urine data to the server. In such a case, the patient enters the patient ID code either before or after the sample the provided. The urinalysis device transmits the patient ID code to the server, and the server retrieves the patient name associated with the entered patient ID code. The name of the patient is then transmitted from the server to the urinalysis device and the urinalysis device displays the name on a user interface of the keypad. Once the user confirms that the displayed name is correct, the raw urine data is transmitted to the server.
[0089] While signal transmitters in direct wireless communication with a server have been described, the urinalysis device may instead include a low range signal transmitter, for example Bluetooth, that connects to a second device such as a local network, smart phone, tablet, laptop, or computer. The low range signal transmitter connects to the second device, and the second device wirelessly connects to the server. In this configuration, the low range signal transmitter extends the life of the battery of the urinalysis device. Some urinalysis devices have both a low range transmitter connected to a second device and a long range signal transmitter wirelessly connected to the server. The report generated from the received raw urine data 113 can then be sent to either or both the phone and the server. The signal transmitters may also connect to a router first and then by wire to a server.
[0090] While the server 104 has been described as being in communication with the patient's computer and the physician's computer, in some implementations, the server is in communication with a blood treatment machine to be used to perform a blood treatment on the patient. In such implementations, a packet of processed data related to the levels of detected properties in the patient's urine is be sent to a blood treatment machine. The blood treatment parameters to be programmed into the blood treatment machine for the patient's blood treatment can be adjusted based on the packet of processed data. In some cases, the data sent to the blood treatment machine includes an entire blood treatment prescription that the clinician can accept in one easy step to carry out the treatment using that prescription. Alternatively, the clinician may review the data and then input the desired blood treatment parameters.
[0091] Additionally, to avoid transmitting erroneous patient data, the urinalysis device may transmit the raw urine data 113 only when the patient's ID is detected by the urinalysis device (e.g., by from an NFC/RFID tag carried by the patient, the patient's fingerprint, or any of the various other patient identification mechanisms described herein) and confirmed as the known patient. In such a case, the urinalysis device would include a controller and a memory that contains the predetermined patient ID data. Once the patient's ID was confirmed, the urinalysis device uses the controller of the urinalysis device to tag the raw urine data with the matched patient ID. The signal transmitter then transmits the tagged, raw urine data to the server for processing and analysis. In this configuration, the urinalysis device may discard the urine data of any unmatched patient ID.
[0092] While the status lights have been described as using specific light patterns to indicate different states of the urinalysis devices, the status lights can alternatively or additionally emit different colors to indicate different actions performed by the urinalysis device. For example, the status light can be red when it is calibrating and cannot receive a urine sample, green when it is ready to receive a urine sample, and yellow when the raw urine sample is being transmitted by the signal transmitter of the urinalysis device. The status light could also have different blinking patterns to indicate the status of the urinalysis device.
[0093] In some implementations, the calibration step and be prompted by a controller of the urinalysis device. The controller can, for example, determine when the toilet is flushed using the water level sensor. When the toilet is flushed, the water level of the toilet rises and falls. The controller recognizes the water level movement using the water level sensor and prompts calibration. The controller may also prompt the biomarker sensor to measure the sample when the water level sensor detects an increase in water level (due to the addition of a urine sample).
[0094] While programs that allow access to the server 104 have been described as requiring the user to select a set of default software scripts as a part of the initial setup of the program, some programs may instead require the clinician to choose software scripts during the initial setup of each urinalysis device, so that each patient has a customized set of one or more software scripts analyzing his/her raw urine data. For example, the clinician may assign one patient a software script that analyzes the proteins in the urine detected by the biomarker sensor while the clinician assigns another patient a software script that analyzes the glucose levels and pH detected by the biomarker sensor. In some programs, the program requires the user to select a set of default software scripts during the initial setup of the program and requests that the user select a customized set of software scripts when the urinalysis device is initially setup. The default set of software scripts and/or the customized set of software scripts may be changed using the program.
[0095] While the processing device that connects to the urinalysis device has been described as a server, the processing device may be any device with adequate processing capability, such as a mobile phone, a tablet, a computer, etc. asked
[0096] While the finger print reader 109 has been described as being positioned on the flushing lever of the toilet 116, it could alternatively be positioned at any of various other locations in proximity to the toilet 116.
[0097] In some systems, the structure of the urinalysis devices may vary. Instead of a hook-like structure, the urinalysis device may be clipped onto the toilet or mounted in a different way so that part of the device remains in contact with the toilet water. The urinalysis device may also be in a stick-shape instead and or disposable.
[0098] While the server has been described as being in communication with a patient's computer 130 and a physician's computer 132, the server can alternatively or additionally be in communication with any of various other electronic devices of the patent and the clinician, including mobile phones, tablets, etc.
[0099] While the server 104 has been described as transmitting a report to a patient's computer and/or to a medical professional's computer, the data transmitted need not be in the form of a formal report. Rather, the data can be in any form that is usable by the patient and/or the medical professional.
[0100] While the urinalysis device 102 has been described as being installed in a toilet at the patient's home, it could alternatively be installed in any toilet to be used by the patient. In some cases, for example, the urinalysis device 102 is installed in a toilet at a dialysis clinic. In such cases, the patient may be asked to urinate in that toilet immediately prior to his or her treatment to get the most up to date data prior to the treatment. That data can then be used to modify the planned treatment if desired.
[0101] Other embodiments are within the scope of the following claims.