MEDICAL DEVICES
20200178906 ยท 2020-06-11
Inventors
Cpc classification
A61B2562/06
HUMAN NECESSITIES
A61B5/7282
HUMAN NECESSITIES
A61B5/208
HUMAN NECESSITIES
A61B5/6887
HUMAN NECESSITIES
A61B2562/04
HUMAN NECESSITIES
A61B5/02055
HUMAN NECESSITIES
A61B5/145
HUMAN NECESSITIES
A61B5/02438
HUMAN NECESSITIES
A61B2562/164
HUMAN NECESSITIES
A61B5/1032
HUMAN NECESSITIES
A61B5/7275
HUMAN NECESSITIES
A61B2562/0219
HUMAN NECESSITIES
A61B5/01
HUMAN NECESSITIES
International classification
A61B5/00
HUMAN NECESSITIES
A61B5/0205
HUMAN NECESSITIES
A61B5/103
HUMAN NECESSITIES
Abstract
An infection sensing system includes a sensor device configured to be fastened onto the skin, the sensor device including multiple sensors and a processor coupled to the sensors. The sensors include at least a temperature sensor to read skin temperature as a proxy for body temperature and a heart rate sensor. The processor inputs data from the sensors, determines data representing body temperature and heart rate, and identifies a combination of: (i) a greater than threshold temperature fluctuation in the body temperature, and (ii) a greater than threshold heart rate, where (i) and (ii) are present for greater than a threshold time duration. Responsive to this identification the system outputs data indicating infection.
Claims
1-38. (canceled)
39. An infection sensing system, the system comprising: a sensor device configured to be fastened onto the skin, the sensor device comprising a plurality of sensors; and a processor coupled to the sensors; wherein the sensors comprise at least: a temperature sensor to read skin temperature as a proxy for body temperature; and a heart rate sensor; and wherein the processor is configured to: input data from said sensors and determine data representing body temperature and heart rate; and identify a combination of: (i) a greater than threshold temperature fluctuation in said body temperature, and (ii) a greater than threshold heart rate, and wherein (i) and (ii) are present for greater than a threshold time duration; and responsive to said identification, store and/or output data indicating infection.
40. The infection sensing system as claimed in claim 39, wherein said sensors further comprise a skin moisture sensor to sense a level of moisture on the surface of the skin, and wherein said processor is configured to identify that a combination of (i) and (ii) and (iii) a greater than threshold skin moisture level, are present for a duration greater than said threshold time duration.
41. The infection sensing system as claimed in claim 39, wherein said sensors further comprise one or more of a chemical sensor or a gas sensor, and wherein said processor is configured to identify that a combination of (i), (ii), optionally (iii), and (iv) a greater than threshold concentration of chemical indicative of a medical condition, are present for a duration greater than said threshold time duration.
42. The infection sensing system as claimed in claim 39, wherein said sensors further comprise an accelerometer, and wherein said processor is further configured to identify, in combination with (i), (ii), optionally (iii), and optionally (iv), a rest state of said body.
43. The infection sensing system as claimed in claim 39, wherein said sensor device comprises an enclosure with a sensing surface comprising a reduced thickness face or membrane to touch the skin, the device comprising two temperature sensors, a first temperature sensor against said sensing surface to measure the body temperature and second temperature sensor on an external face of said enclosure opposite said sensing surface to measure an environment temperature; wherein said enclosure includes sensing system electronic circuitry mounted on said external face and thermally insulated from said sensing surface; and wherein said processor is configured to compensate a sensed body temperature for said environment temperature.
44. The infection sensing system as claimed in claim 39, wherein said processor is configured to: identify a first combination (i) and (ii) with a first threshold heart rate and a first threshold time duration and a second combination (i) and (ii) with a second threshold heart rate and a second threshold time duration; wherein said second threshold heart rate higher than said first threshold heart rate and wherein said second threshold time duration is shorter than said first threshold time duration; and categorise an infection into one of at least first and second categories responsive to respective identification of said first and second combinations; wherein said data indicating infection indicates said category of infection.
45. The infection sensing system as claimed in claim 39, wherein said sensor device comprises an enclosure with a sensing surface comprising a reduced thickness face or membrane to touch the skin and an external face opposite said sensing surface, wherein said enclosure includes sensing system electronic circuitry; and wherein the sensor device further comprises an electrical power supply comprising a thermoelectric power generating device thermally coupled between said sensing surface and said external face to generate electrical power for said electronic circuitry from a temperature difference between the skin and the environment.
46. The infection sensing system as claimed in claim 39, wherein said sensor device comprises a flexible circuit board with an adhesive layer or region to attach the circuit board to the skin, in particular wherein the sensor device is in the form of a plaster.
47. A method of sensing infection using the infection sensing system of claim 39, the method comprising: measuring body temperature and/or heart rate and skin moisture level; and identifying a combination of: (i) a greater than threshold temperature fluctuation and/or a combination of: (ii) a greater than threshold heart rate, and (iii) optionally a greater than threshold skin moisture level; wherein (i), (ii), and optionally (iii), are present for greater than a threshold time duration; and responsive to said identification storing and/or outputting data indicating infection.
48. A non-transitory data carrier carrying processor control code to implement the method of claim 47.
49. A urine-flow based diagnostic system, the system comprising: a sensor device for use in a toilet bowl or urinal so as to intersect a stream of urine, the sensor device comprising a urine stream flow sensor; and a processor coupled to said urine stream flow sensor; and wherein the processor is configured to: determine, from said urine stream flow sensor, a flow rate parameter dependent on a sensed urine flow; and responsive to said flow rate parameter, store and/or output data indicating presence of a potential medical condition.
50. The system as claimed in claim 49, wherein said processor is further configured to identify, from said flow rate parameter, when a flow of said stream of urine is intermittent to identify presence of said potential medical condition.
51. The system as claimed in claim 50, wherein said processor is configured to identify the presence of a plurality of peaks in said flow rate to identify presence of said potential medical condition.
52. The system as claimed in claim 51, wherein said processor is configured to distinguish between the presence of a prostate condition and an infection dependent upon one or both of a number of said detected peaks and a flow rate of said stream of urine.
53. The system as claimed in claim 51, wherein said processor is configured to characterise a timing of said peaks to identify presence of potential infection.
54. The system as claimed in claim 53, wherein characterisation of said timing comprises one or more of: determining a time duration, T1, between one or more of said peaks; determining a time duration, T2, of a period of reduced or substantially zero flow between one or more of said peaks; determining a time duration, T3, of one or more of said peaks; determining a ratio between T2 and T3.
55. The system as claimed in claim 54, wherein said characterisation comprises identifying presence of potential infection by identifying when T2 is increased or above a threshold value and/or T3 is reduced or below a threshold value.
56. The system as claimed in claim 49, wherein said processor is configured to identify when a peak flow rate is less than a threshold to identify presence of said potential medical condition, in particular identify the potential presence of a prostate condition dependent upon a flow rate range of said stream of urine.
57. The system as claimed in claim 49, wherein said sensor device further comprises a urine stream colour sensor; and wherein said processor is further configured to identify presence of the potential medical condition responsive to a detected degree of colouration of said urine.
58. The system as claimed in claim 49, wherein: said sensor device further comprises a chemical sensor, and said processor is further configured to identify presence of the potential medical condition responsive to a detected concentration of a chemical indicative of a medical condition within said urine; and/or said sensor device further comprises a gas sensor and said processor is further configured to identify presence of the potential medical condition responsive to a detected concentration of a chemical indicative of a medical condition in gas deriving from said urine.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0071] These and other aspects of the invention will now be further described, by way of example only, with reference to the accompanying figures, in which:
[0072]
[0073]
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[0075]
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[0078]
DETAILED DESCRIPTION OF PREFERRED EMBODIMENT
[0079] Referring to
[0080] The gas sensor 125 may be a chemical gas sensor and/or an electrochemical nose (e-nose). An example of a gas sensor is the Figaro TGS2602-B00 Air Contaminants Gas Sensor. The gas sensor 125 may be configured to detect the concentration of one or more chemicals in gas in or around the toilet bowl or urinal. The chemical sensor 123 may be configured to detect the concentration of one or more chemicals within the urine. This may be through one or more receptors configured to interact with one or more chemicals to detect the one or more chemicals and measure the associated concentration.
[0081]
[0082]
[0083] Referring next to
[0084] The procedure also collects data from the temperature sensors and humidity sensor (S208) and processes the temperature sensor data to determine an estimated body temperature, and processes the humidity sensor data to determine an estimated skin moisture level (S210); at this point the procedure also has the heart rate data. In embodiments, the raw and/or processed sensor data may optionally be logged for later interrogation. The procedure then applies criteria to the heart rate, temperature and moisture levels to determine whether or not there is a potential infection (S212).
[0085] In further embodiments, chemical concentration data (such as from a chemical or gas sensor) may also be input at step S208 and compared to a respective threshold in step S212 to determine whether there is a potential infection.
[0086] If no potential infection is identified the procedure loops back to re-check the sensor data; if there is a potential infection the procedure logs the potential infection and loops back (S214) to repeat the test at intervals, for example, every few hours.
[0087] At step S212 embodiments of the procedure identify the combination of a temperature fluctuation between high and low temperature values in combination with a raised heart rate, where the elevated heart rate may be determined with respect to an absolute threshold in beats per minute (bpm) or with respect to a heart rate dependent upon an individual or category of individual, for example an age-dependent heart rate. Optionally multiple combinations of heart rate and temperature fluctuations may be identified. For example, a first set of conditions may comprise detecting, during a 3 hour period, that the heart rate goes above 71 bpm on at least one occasion and that there is at least one high-low temperature fluctuation (whilst the body is in its rest state). Such a condition may determine infection with a first probability, for example 75%. A second set of conditions may, for example, define that during a period of 1 hour the heart rate at some point exceeds 75 bpm and there is a high-low temperature fluctuation, again whilst the body is in its rest state; this may define a higher probability of infection, for example 88%. A requirement for an increased skin moisture level may also be included. A third example condition may detect an increased heart rate and an increased moisture level whilst the body temperature is approximately normal; a fourth type of condition may identify a temperature fluctuation without requiring an increased heart rate or increased skin moisture level. One or more of these types of condition may be employed; preferably all are determined when the body is in its rest state.
[0088] Once infection data has been determined this data is stored and at some convenient time output on a wired or wireless connection (S216). The infection data may comprise a single bit defining whether or not an infection has been identified, and/or it may include information identifying a level and/or probability of infection and/or it may include data identifying a type of infection or set of conditions identified (as described above), and/or the data may include raw or processed sensor data, for example so that a medical practitioner may review the historically measured heart rate and/or temperature and/or moisture data.
[0089] Optionally (un)supervised machine learning may be applied to the raw and/or processed data and/or output data (S218) to provide a more robust indication of potential infection. The machine learning may be implemented on the device of
[0090] Whilst the above embodiments discuss infection sensing, alternative embodiments may be configured to detect a medical condition. For instance, an increase in glucose measured by a chemical sensor may indicate diabetes. Equally, the processor may be configured to detect other medical conditions, such as cancer, through the detection of associated chemicals (e.g. one or more expressions of genes associated with cancer).
[0091] The infection sensing system may be configured to reset measurements after use. This allows the system to be used with a different user. The reset ensures that measurements from a previous user are not erroneously associated with a new user. The reset may be in response to the system being removed from the skin of a user (identified by changes in the detected skin moisture, temperature and pressure). Alternatively, the reset may be via using a magnetic wave from a magnetic tag, and RFID signal from an RFID tag, from a wireless signal (e.g. a Bluetooth signal or a command from a wireless base station), or from a reset input such as a button.
[0092] Various different alternative sensing arrangements and combinations of conditions are contemplated within the scope of the invention. For example, in one aspect the invention may include just a temperature sensor and may detect a greater than threshold variation in temperature over a period of time. Alternatively the invention may include sense heart rate and moisture sensors but omit a temperature sensor, and may detect a combination of increased heart rate and increased moisture over a period of time. As previously stated, the moisture sensor is optional but preferable.
[0093] As previously described, the device itself may provide a signal or may communicate by means of a wired or wireless connection with a base unit or base station, for example a mobile phone, desktop computer or the like. The skilled person will appreciate that, in the various different aspects of the invention, the infection data may be provided via a network such as a mobile phone network or the internet, for example to alert a carer. Additionally or alternatively, an alarm may be triggered should an infection level greater than the threshold and/or a persistent infection be detected.
[0094] Urine-Based Sensing
[0095]
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[0097]
[0098] Once flow has been detected the procedure begins gathering data from the accelerometer and/or turns on the acoustic sensor (microphone), S404. Data is then collected from the accelerometer and/or acoustic sensor (S406) and, in embodiments, also from the pressure sensor (S408). These data are used to determine the urine flow rate (S410), for example by integrating the X, Y and Z-axis accelerometer signals to determine a direction-insensitive flow rate and then optionally combining this, for example by weighted average, with a flow rate from the pressure sensor, to determine time series flow rate data.
[0099] Optionally the accelerometer data may also be provided to a routine S412 which estimates the gender, for example from the standard deviation of the X-, Y- and Z-accelerometer signal components (greater for males than for females). This information may provide information to the flow-end detection procedure S402 as the male and female end of flow behaviour differs. In broad terms, therefore, embodiments of the device may estimate the user's gender, and then adapt the operation of the device in response to the user's gender, in particular to increase the accuracy of the data obtained. Although in embodiments this information is applied to end of flow detection a skilled person will appreciate that knowledge of gender may be used in other ways to improve the accuracy of the measurements.
[0100] Once flow rate has been determined, the procedure identifies the absolute flow rate as a low flow rate, for example less than 10 ml/s, can indicate infection (S412). Additionally or alternatively the procedure identifies flow fluctuations. In some preferred embodiments the procedure identifies when the flow falls to substantially zero, and preferably also determines a duration or an average duration between such intervals and/or counts a number of such intervals. In particular, the duration between points at which the flow approaches zero is useful for identifying a potential infection. More particularly, where an infection is present there may be an extended period of time for which the flow is close to zero (below a threshold level). Thus there may be short intervals of flow punctuated by relatively long delays. In embodiments, therefore, the device may time the duration of one or more of such delays between intervals of flow and determine a delay or an average delay. In broad terms, the longer the delay between intervals of flow the greater the likelihood of infection and/or greater the degree of infection. The skilled person will appreciate that there are many ways to define a threshold level of flow in order to count or time durations of low flow or intervals between duration periods of flow.
[0101] In further embodiments, a gas and/or chemical sensor is/are turned on at step S404 and measure chemical concentration at step S406. This concentration data is input in step S410 to determine whether there is a potential infection.
[0102] At step 414 the procedure determines and stores/outputs infection data. As previously, this may be a simple binary bit indicating the presence or absence of potential infection. However more information may be provided, for example information indicating a degree of infection, a probability of infection, a type of potential infection, infection characterising data, raw and/or processed sensor data, and so forth. In particular, the device may include an optical sensor to provide colourimetric data (S416) and/or a temperature sensor to provide temperature data (S418).
[0103] Referring now to
[0104] The device may further include a chemical sensor and/or a gas sensor (not shown). The chemical/gas sensors may be at least partially exposed through the casing.
[0105] The sensor device shown in
[0106] The sensor device for use in position C may be mounted on a pivoting mechanism and may include a motor to move the enclosure 532 up, away from the water. A cleaning system may be located above the sensor device. The cleaning system may comprise a reservoir and may be configured to release fluid (e.g. cleaning fluid) to clean the sensor device (e.g. flush away waste). This is because the conventional flush mechanism in a toilet may not be sufficient to remove contaminants from the sensors. The pivoting mechanism may allow cleaning fluid to be collected over the sensors to improve the cleaning action. Once the sensing device has been cleaned, the pivoting mechanism may return the sensing device to its previous position (position C).
[0107]
[0108]
[0109] At S700 the procedure captures pressure data as a proxy for urine flow rate, and optionally data for an optical measurement of urine colour/opacity. In embodiments the pressure data may be converted to a flow rate in ml/sec based upon a calibration (which may be linear or non-linear). Although shown as a single step data are captured at intervals of a few milliseconds; the system may be woken up automatically to collect data.
[0110] The procedure performs peak and peak-timing detect S702, in one implementation by first smoothing the input data (e.g. filtering in the time domain), and then storing the captured data in a time-series array. A peak may be detected by matching values to either side of a detected maximum; this can be used to determine the duration of a peak. An inter-peak duration may be determined by matching values to either side of a detected minimum. For example in one embodiment the flow rate values in ml/sec are quantised to integer values and then values to either side of a minimum identified (e.g. if the minimum is 2 ml/sec an inter-peak duration may be determined from the interval between flow rates of 3 ml/sec). Once peaks have been identified they may be counted and an inter-peak timing determined, as well as a maximum flow rate for the peak. In embodiments flow rates below a threshold (e.g. 0.2 ml/sec) are disregarded; in embodiments the final two peaks identified are also discarded.
[0111] The procedure then processes that data to determine signals of potential infection and of a potential prostate condition (S704). Test as previously described in the Summary of the Invention may be employed. In embodiments multiple signals are required to be present in combination for a positive detection of a potential medical condition. Test applied may include one or more of: Detection of multiple peaks; detection of a low flow rate (<10 ml/sec or <5 ml.Math.sec); detection of an extended time between peaks (>0.5 sec) for infection; detection of less than a threshold or zero time between peaks for a prostate condition; detection of greater than a threshold peak duration (e.g. greater than 10 sec, 15 sec or 20 sec) for a prostate condition.
[0112] A result of this processing may be stored and/or output as data indicating the presence of a potential medical condition and, optionally, whether the condition is an infection or a prostate-related condition. Optionally a potential degree of severity of the condition may also be indicated. Additionally or alternatively the raw data from S700 and/or processed data from S702 may be provided. In embodiments an alert and/or the raw/processed data may also be provided on display device 606 and/or communicated to a remote server for further storage/processing.
[0113] In embodiments data from one or more of steps S700, S702 is provided to a machine learning procedure S706, for example running in base station 604 and/or on a remote server. The procedure may implement a supervised or unsupervised learning algorithm, for example using supervised learning in combination with data inputted from diagnoses previously made using data from the system, or using unsupervised learning to classify the input data. The machine learning procedure may thus learn to provide improved data indicating the presence of a potential medical condition, and/or differentiation of one or more conditions (such as infection and prostate-related conditions).
[0114] Further parameters may be utilised to detect infections or medical conditions. These parameters may include chemical concentration (either in urine or in gas emanating from the urine) and time or frequency of urination.
[0115] Whilst the above embodiments discuss the detection of an infection, embodiments may be configured to detect other medical conditions, such as cancer, kidney stones or diabetes. For instance, diabetes may be detected through increased frequency of urination at night and/or increased glucose or ketone concentrations in urine. Equally, cancer, such as prostate cancer, may be detected through an increased concentration of chemicals associated with genes associated with the cancer (e.g. PSA and expressions of TMPRSS2:ERG or PCA3).
[0116] As previously described, the device itself may provide a signal or may communicate by means of a wired or wireless connection with a base unit or base station, for example a mobile phone, desktop computer or the like. The skilled person will appreciate that, in the various different aspects of the invention, the infection data may be provided via a network such as a mobile phone network or the internet, for example to alert a carer. Additionally or alternatively, an alarm may be triggered should an infection level greater than the threshold and/or a persistent infection be detected.
[0117] The urine-flow based diagnostic system may be configured to connect to one or more further sensing devices. For instance, the urine sensing device may receive measurements taken by the infection sensing systems described with reference to
[0118] The urine-flow based diagnostic system may be configured to reset measurements after use. This reset ensures that measurements from a previous user are not erroneously associated with a new user. The reset may be in response to the system being flushed (either by an external flushing mechanism or via the cleaning mechanism described above). Alternatively, the reset may be via using a magnetic wave from a magnetic tag, an RFID signal from an RFID tag, from a wireless signal (e.g. a Bluetooth signal or a command from a wireless base station), or from a reset input such as a button or pull-chord.
[0119] The systems described herein may associate measurements with users through the use of a unique user identifier. This may be input via a command from an external system (e.g. via a wireless interface), or may be input from an RFID tag or magnetic tag that the system is configured to read. This allows the system to be used with different users, and for measurements to be taken over time and associated with the respective user. This may be particularly advantageous for the urine-flow based diagnostic system (although it may be implemented by the infection system of
[0120] The processing has been described as taking place at the sensing device but the skilled person will appreciate that in embodiments the processing may be partly or substantially wholly at a mobile or fixed computing device with which the sensing device communicates. Thus the device may transmit sensor data, for example via a Bluetooth or other link, to a mobile device implementing a procedure as described above. Alternatively the processing may be distributed, partly on the sensing device and partly on, say, a mobile device.
[0121] No doubt many other effective alternatives will occur to the skilled person. It will be understood that the invention is not limited to the described embodiments and encompasses modifications apparent to those skilled in the art lying within the spirit and scope of the claims appended hereto.