Systems, methods, portable devices, computer equipment, and computer programs for monitoring, characterizing, and evaluating a user's cough.

Abstract

This invention relates to a system for monitoring, characterizing, and evaluating a user's cough, comprising: a sensing instrument unit (2) including at least one abdominal contraction sensor (3) and at least one acoustic sensor (4), the acoustic sensor (4) being triggered only when abdominal contraction is detected; a microcontroller (1); at least one data stream unit; and a data processing and analysis unit (5) for cough evaluation. This invention addresses the problem of insufficient cough evaluation in medical practice by establishing parameterized cough patterns involving cough frequency, cough type, user's body position, and other data that may cause cough events, enabling objective analysis of cough and facilitating medical diagnosis. This invention also protects user privacy because acoustic sensor data is recorded only when abdominal contraction is present.

Description

Technical Field

[0001] This invention relates to systems that support medical diagnosis, particularly the monitoring, characterization, and assessment of a user's cough.

[0002] The present invention also relates to a method for monitoring, characterizing and evaluating a user’s cough using the system, a portable device, a computer device, a computer program and a method for reading by the computer device. Background Technology

[0003] Coughing is a common symptom in humans and a necessary mechanism for protecting the body. It is the most frequently mentioned symptom when patients seek medical advice and the most common reason for visiting primary healthcare. Furthermore, a persistent cough, meaning a cough lasting more than three weeks, is the most common reason for seeing a respiratory specialist. It is worth noting that an increased frequency and intensity of coughing can interfere with breathing, eating, and sleeping, thereby reducing quality of life and impairing a patient's health and well-being.

[0004] Several factors can cause acute, persistent, and chronic cough, including upper respiratory tract infections, asthma, chronic obstructive pulmonary disease (COPD), gastroesophageal reflux, pneumonia, heart failure, lung cancer, and postnasal drip. Coughing can be the first obvious sign of respiratory or lung disease, at which point it represents more than just a defense mechanism. Due to its persistence and unique characteristics, coughing becomes a useful indicator of the development or progression of an underlying disease. Therefore, coughing is a very important symptom in the context of its underlying condition.

[0005] Therefore, a complete and comprehensive assessment of a patient's cough is fundamental to identifying and treating its underlying causes, as each individual may have different factors contributing to their condition. This assessment should include the frequency of the cough; the type of cough, i.e., whether it is purulent and / or dry, and whether there are other characteristics, such as whether it is accompanied by wheezing; and possible patterns associated with the frequency and type of cough, such as whether the cough is predominant at night, and patterns associated with events that may trigger the cough, such as whether lying position provokes a cough attack.

[0006] The characteristics and patterns of cough vary depending on the disease. In cases of asthma exacerbation, cough attacks primarily occur at night and in the early morning. Another example is exercise-induced asthma, where one of the most prominent symptoms is coughing during or after physical activity. In cases of gastroesophageal reflux, cough attacks may trigger gastroesophageal reflux due to abdominal muscle contractions and the resulting increase in intra-abdominal pressure, which facilitates the rise of gastric juices. On the other hand, reflux attacks can be triggered by a reflex mechanism, which is caused by the rise of gastric juices through the esophagus and subsequent inflammation and irritation of the upper airway (rather than due to an existing respiratory condition). For reflux-induced coughs, the cough attack may worsen when the patient lies down, as gastric juices are more likely to rise.

[0007] However, despite its importance, coughing is considered a highly subjective symptom. For example, some patients may perceive their cough as frequent, while others may not perceive the same cough in the same way. In the case of daytime cough, the description of its predominance relies heavily on patient memory and subjectivity. In the case of nighttime cough, it is rare to accurately recall cough episodes. Furthermore, patients often misclassify their cough types, and forced coughing during consultation does not reflect spontaneous coughing or its development over time. All of these factors contribute to the subjectivity and difficulty in assessing cough in clinical practice, often posing significant challenges to the analysis by healthcare professionals.

[0008] It is well known that doctors and healthcare providers have long needed a reliable and portable device that can be used without disrupting daily routines to provide a comprehensive quantitative and qualitative assessment of a patient’s cough, allowing for early detection of several conditions associated with cough and potential coughs, thereby improving diagnosis and treatment.

[0009] There are currently no cough monitoring tools available for clinical practice, which leaves doctors with incomplete and often subjective and inaccurate information when diagnosing their patients.

[0010] Existing technologies have revealed some devices designed to supplement medical diagnosis based on cough events.

[0011] International patent application WO2013142908A1 (University of Queensland, March 3, 2013, pages 6-8 of description and abstract) discloses a device for detecting and characterizing cough types based on audio recordings. Based on the classification of cough events, coughs can be characterized as, for example, dry coughs or expectorative coughs, and ultimately associated with a disease. The device may include additional sensors for monitoring other user data, such as motion sensors and EEG sensors. However, this device has limitations for cough classification methods based solely on audio signals, as the results of cough classification may be insufficient for a more complete characterization and evaluation of the user. Although the device may include several additional sensors, these sensors are not used to detect cough patterns. The device continuously records audio, repeatedly recording the user's private conversations, and does not preserve the user's privacy rights.

[0012] Patent application CN108294756A (published by the First Affiliated Hospital of Guangzhou Medical University et al., July 20, 2018, abstract) discloses a device with several sensors, such as a microphone, an electromyography (EMG) sensor with a three-electrode configuration, and an accelerometer, for detecting cough events and quantifying their intensity. The device described in this reference uses the EMG sensor and accelerometer as an adjunct to the microphone to detect a user's cough events. However, the device does not characterize the type of cough, such as a dry cough or a expectorating cough, nor does it establish a cough pattern or provide information that can be used to help diagnose the user's clinical condition. The device can continuously record audio, as well as the user's conversation, and a computer program can later analyze the recording and delete portions containing speech.

[0013] In addition, compared with the present invention, the devices shown in WO2013142908A1 and CN108294756A both have the problem of continuously recording and analyzing user audio signals, resulting in the loss of user privacy.

[0014] Therefore, there is a need to develop devices capable of conducting more objective and comprehensive cough assessments; that is, devices that can establish cough patterns and extract relevant information to help physicians make more effective and accurate clinical diagnoses. Additionally, there is a need to develop devices that collect sound signals for cough characterization while protecting user privacy and interpersonal interactions in both private and public spaces.

[0015] The main objectives of this application are: (1) to provide physicians and other healthcare professionals with a portable, easy-to-use tool that allows for the monitoring and objective analysis of users’ coughs; and (2) to provide users with an applicable device that, through a simple and easy-to-use system that does not interfere with their daily routines or privacy, combined with cough monitoring methods, will provide healthcare professionals with a more effective tool for early and efficient diagnosis.

[0016] The purpose of this invention is to comprehensively characterize and evaluate cough by monitoring and automatically detecting several essential parameters, in order to help users achieve accurate diagnosis, for example: • Frequency of coughing, especially the number of times a user coughs and the distribution of cough events over time; • The type of cough, especially whether it is a dry cough, a cough with phlegm, and / or a cough at all. Other characteristics, such as whether it is accompanied by wheezing; and • Cough patterns, which include the frequency and type of coughs, the user's location and body movements, and other supplementary information data that may contribute to coughing events.

[0017] From the perspective of current technology, it is currently unknown whether there is a portable device or system capable of conducting a comprehensive cough assessment, providing an analytical report that includes several parameters related to the type and frequency of the cough, and linking them to patterns important for diagnosis, i.e., providing additional information on events that may trigger a cough by including additional sensors and auxiliary devices.

[0018] Therefore, the system for monitoring, characterizing and assessing a user's cough described and claimed in this invention can provide a complete assessment of the user's cough and will facilitate and accelerate the diagnosis of underlying diseases, and can serve as a supplementary diagnostic tool for healthcare professionals.

[0019] In addition to its usefulness as a tool in clinical practice, the value-adding capabilities of this invention also allow it to be used in the field of medical research, particularly for studying the effects of certain drugs or pathologies on cough. Attached Figure Description

[0020] To facilitate understanding of the principles of embodiments of the present invention, reference will be made to the embodiments shown in the accompanying drawings and the language used. In any event, it should be understood that the scope of the invention is not intended to be limited to the contents of the drawings. Any subsequent changes or modifications to the inventive features described herein, as well as any additional applications to the principles and embodiments of the invention illustrated (which would typically occur to those skilled in the art with this description), are considered to be within the scope of the claimed invention.

[0021] Figure 1 An embodiment of the system of the present invention is shown, in which the electromyography surface sensor is in contact with the user's body; Figure 2 The embodiment of the system of the present invention illustrates the sensing signals collected by the surface electromyography sensor; Figure 3 An embodiment of the system of the present invention is shown, in which the sensing signal collected by the acoustic sensor is activated by the microphone activation unit based on the surface electromyography sensor. Figure 4 An acoustic sensor activation algorithm is shown, which detects abdominal contraction events using an abdominal contraction sensor. Figure 5 An embodiment of the system of the present invention is shown, in which heartbeat signals are collected by a surface electromyography sensor; Figure 6 A first embodiment of the system according to the present invention is shown; Figure 7 A second embodiment of the system according to the present invention is shown; Figure 8 A first embodiment of a system incorporated in a patch according to the present invention is shown; Figure 9 A second embodiment of the system incorporated in a patch according to the present invention is shown; Figure 10 A functional block diagram of the processing unit and data analysis for cough assessment is shown; Figure 11 An embodiment of fault detection during the collection of sensing signals is shown, which is caused by poor contact between the electromyography surface sensor and the user's body. Figure 12 Another embodiment of fault detection in the collection of sensing signals due to insufficient contact between the surface electromyography sensor and the user's body is shown; Figure 13 An example of a nighttime dry cough pattern obtained by the system of the present invention is shown, using an abdominal contraction sensor and an acoustic sensor; Figure 14 An example of a cough pattern obtained by the system of the present invention is shown, using an abdominal contraction sensor, an acoustic sensor, and a body positioning and motion characterization sensor. Figure 15 An embodiment of the system according to the invention is shown, synchronized with an external pH measuring device, in which a causal relationship between cough and gastroesophageal reflux can be observed. Detailed Implementation

[0022] In a first aspect, the present invention relates to a system for monitoring, characterizing, and evaluating a user's cough, the system comprising a sensing instrument unit 2, the sensing instrument unit 2 comprising: • At least one abdominal contraction sensor 3, adapted to contact the user's body; and • At least one sound sensor 4, suitable for proximity to the user; The abdominal contraction sensor 3 and the acoustic sensor 4 collect and transmit raw sensing signals to the sensing instrument unit 2; The sensing instrument unit 2 adjusts the signals of the abdominal contraction sensor 3 and the acoustic sensor 4; It also includes a microcontroller 1, which includes: • Data acquisition unit 43 obtained from the sensing instrument unit; and • Acoustic sensor activation unit 44 activates the acoustic sensor 4 only when an abdominal contraction is detected from the abdominal contraction sensor 3. When activated, the acoustic sensor 4 only collects and transmits the raw sensing signal to the sensing instrument unit 2; and The data acquisition unit 43 obtained by the sensing instrument unit and the acoustic sensor activation unit 44 of the microcontroller 1 are related in a certain sense, that is, data is only acquired from the acoustic sensor when the acoustic sensor activation unit is activated. It also includes at least one data stream unit selected from the group consisting of data transmission and reception unit 17 and data storage unit 18, said data stream unit being controlled by microcontroller 1; It also includes a data processing and analysis unit 5 for cough assessment, configured to process and analyze data generated by the operation of the microcontroller 1 and to monitor, characterize and assess the user's cough.

[0023] In a second aspect, the present invention relates to a method for monitoring, characterizing, and evaluating a user's cough using a system according to the invention, the method comprising the following steps: i. At least one abdominal contraction sensor 3 included in the sensing instrument unit 2 comes into contact with the user's body; ii. Bring at least one acoustic sensor 4 included in the sensing instrument unit 2 close to the user's body; iii. The raw sensing signal is transmitted from the active sensor to the sensing instrument unit 2; iv. The signals of the abdominal contraction sensor 3 and the acoustic sensor 4 (if activated) are adjusted by the sensing instrument unit 2; v. The acquisition of data obtained by the sensing instrument unit 2 is controlled by the microcontroller 1; vi. The microcontroller 1 controls the activation of the acoustic sensor 4 only when the abdominal contraction sensor 3 detects abdominal contraction. When the acoustic sensor 4 is activated, it collects and transmits the original sensing signal to the sensing instrument unit 2. vii. Data is received by the data processing and analysis unit 5 for cough assessment; viii. The user's cough is monitored, characterized, and evaluated by the data processing and analysis unit 5 used for cough assessment.

[0024] In a third aspect, the present invention relates to a portable device for monitoring, characterizing and evaluating a user's cough, including a system according to the invention and a method for attaching it to a user's body.

[0025] In a fourth aspect, the present invention relates to a computer device comprising a processor configured to perform one or more steps of the method of the present invention.

[0026] In a fifth aspect, the present invention relates to a computer program comprising instructions that enable a computer device according to the invention to perform one or more steps of the method of the invention.

[0027] In a sixth aspect, the present invention relates to a method for reading via a computer device, comprising installing a computer program according to the invention.

[0028] The system according to the invention provides reliable and useful parametric cough patterns for medical diagnosis in a surprising way, compared to other known devices in the prior art. The system of the invention can create a set of cough patterns based on cough frequency and type obtained through abdominal contraction and audio sensors. Furthermore, additional cough patterns can be obtained by combining other sensors and external devices, which infers events that may cause coughing. The results provided by the system of the invention include: 1) cough frequency; 2) cough type; and 3) patterns relating to cough frequency, type, and potential causal cough events. In embodiments of the invention, events that may cause coughing can be obtained based on detection by body positioning and motion characterization sensor 9. Additionally, gastroesophageal reflux events can be obtained based on pH measurement device 12. Furthermore, abrupt temperature changes can be obtained based on temperature sensor 11. Moreover, abnormal cardiac events can be detected by electrocardiogram sensor.

[0029] Therefore, this invention addresses the problem of insufficient cough assessment in clinical practice, thereby enabling objective analysis of a user's cough and facilitating medical diagnosis by establishing a parametric cough pattern that includes the frequency and type of cough, the user's body position, and other additional data that may lead to cough events.

[0030] The system of this invention can be used by human users of different ages. As those skilled in the art will understand, the system is also applicable to other mammals, including pets and domestic animals.

[0031] The system of the present invention will now be described in detail based on the characteristics of each of the main components of the present invention.

[0032] Sensing Instrument Unit The system of the present invention acquires data from various sensors, namely at least one abdominal contraction sensor 3 (e.g., a surface electromyography (EMG) sensor with a dual-electrode configuration) and at least one acoustic sensor 4. Additionally, other sensors may be added, such as a body positioning and motion characterization sensor 9, a temperature sensor 11, at least one electrocardiogram sensor, etc.

[0033] The integration of additional sensors allows the data processing and analysis unit 5 for cough assessment to detect patterns based on potential causes of cough events. For example, additional sensors allow for the detection of cough patterns attributable to specific underlying conditions. Specifically, a triaxial accelerometer can detect cough patterns induced by lying position, indicating a correlation between cough and gastroesophageal reflux. On the other hand, the same accelerometer allows for characterization of the user's movement, enhancing the correlation between body movement cycles and severe cough episodes, a typical pattern of exercise-induced asthma. Finally, an electrocardiogram sensor allows for the discovery of causal relationship patterns between premature ventricular contractions (PVCs) and cough events.

[0034] In a preferred embodiment of the invention, the sensors used in the system include a sensing instrument unit 2, which can be controlled by a microcontroller 1. The sensing instrument unit 2 is responsible for regulating signals, particularly the abdominal contraction sensor 3, the acoustic sensor 4, and (when present) the body positioning and motion characterization sensor 9, the temperature sensor 11, and other additional sensors. As will be described in detail throughout the specification, data is regulated by the sensing instrument unit 2, and control of data acquisition is performed by the microcontroller 1, which is also responsible for activating the acoustic sensor when abdominal contraction occurs. A data processing and analysis unit 5 for cough assessment is responsible for monitoring, characterizing, and evaluating the user's cough.

[0035] The conditioning phase of the active sensor signal, performed by the sensing instrument unit 2, is responsible for the initial processing of the original sensing signal, that is, using conditioning techniques known in the art to attenuate noise and artifacts present in the data acquired by the sensor included in the sensing instrument unit 2, which will be obvious to those skilled in the art.

[0036] In a preferred embodiment, the data processing unit 5 for cough assessment uses data obtained through the operation of sensors included in the sensing instrument unit via a microcontroller, namely data acquisition and microphone activation, as well as data from synchronized external devices and other information such as anthropometric user data.

[0037] In a preferred embodiment of the invention, the sensing instrument unit 2 also receives raw sensing signals from the body positioning and motion characterization sensor 9 and modulates the signals from the sensors. According to the method of the invention, the data processing and analysis unit 5 for cough assessment evaluates additional cough patterns based on data from the additional sensors, using the following additional step: i. The body positioning and motion characterization sensor 9 included in the sensing instrument unit 2 comes into contact with the user's body; ii. Collect and transmit sensing signals from body positioning and motion characterization sensor 9 to sensing instrument unit 2.

[0038] Additionally, the sensing instrument unit 2 includes one or more external sensing instrument units 25, i.e., additional sensors, such as temperature sensors and electrocardiogram sensors.

[0039] In a preferred embodiment of the invention, the sensor used in the sensing instrument unit 2 can be analog or digital. In another embodiment, additional integration of an analog sensor may involve adding one or more external analog-to-digital converters to the microcontroller 1.

[0040] In a preferred embodiment of the invention, the abdominal contraction sensor 3 is an electromyography (EMG) sensor with at least two electrodes. In a more preferred embodiment, the EMG sensor has a two-electrode configuration. The EMG sensor is used to monitor muscle contractions in the abdominal wall (upper stomach region) during a user's cough. The EMG sensor, particularly by means of the surface electrode 6, is placed at a specific location on the skin of the user's abdomen or upper abdomen region to optimize the collection of sensory data that allows for the capture of muscle activation caused by the user's cough.

[0041] The sensing unit of the electromyography (EMG) sensor uses an instrumentation amplifier to obtain the EMG signal from the potential captured by the surface electrodes. Within the sensing unit, initial noise attenuation is achieved through common-mode rejection and analog filtering of the signal. Furthermore, the signal is amplified to facilitate reading by the analog-to-digital converter of the microcontroller 1.

[0042] like Figure 1 As shown, electrodes are used to place electromyography (EMG) surface sensors on the user's body, wherein: i. The upper electrode 7 of the surface electromyography sensor is in contact with the user's body below the xiphoid process of the sternum and above the linea alba, that is, the connective tissue zone corresponding to the midline of the rectus abdominis muscle, near the V to VII cartilages of the ribs. ii. Place the lower electrode 8 of the surface electromyography sensor on an imaginary line containing the upper electrode 7, parallel to the costal margin, at the rectus abdominis muscle in the upper abdomen. This electrode can be positioned to the left or right of the midline.

[0043] iii. Optional auxiliary electrodes can be used to directly contact the bone-dominant area, namely the iliac crest.

[0044] In other embodiments of the invention, it is possible to omit the additional electrodes associated with the electromyography (EMG) sensor, which would allow the system to have only one EMG sensor with a two-electrode configuration connected to the user's body. This gives the invention additional advantages in terms of ergonomics and ease of use compared to prior art devices that use EMG sensors for cough detection.

[0045] In one embodiment of the invention, a surface electrode with a gel is used to acquire electromyographic signals and is adhered to the skin in the previously mentioned area. In another embodiment of the invention, the surface electrode with a gel can be replaced by a conductive Lycra electrode, a gel-free electrode, or other types of electrode that do not contain gel and are not adhered to the skin.

[0046] Figure 2 The image shows an example of sensing signals collected and transmitted by an electromyography (EMG) sensor over a long monitoring period.

[0047] It will be apparent to those skilled in the art that each type of abdominal contraction sensor 3 is placed on the user in a different manner. Other examples of abdominal contraction sensors are inductive respiratory plethysmography sensors, piezoelectric sensors, or impedance respiratory plethysmography sensors, which can be placed on the user's body. Figure 1 The different locations shown.

[0048] In a preferred embodiment of the invention, the acoustic sensor 4 includes an omnidirectional microphone that collects and transmits raw sensing signals to the sensing instrument unit 2. The acoustic sensor is designed to characterize the type of cough a user has, and to support abdominal contraction when a cough event is detected. The acoustic sensor activation unit 44 controls the collection of acoustic sensing signals and is designed to acquire data momentarily after muscle activation or abdominal contraction. Control is achieved via the acoustic sensor activation unit 44 of the microcontroller 1, and is designed to avoid recording private personal information and redundant information used to characterize the cough type, which may occur during continuous monitoring of the user's and those around them. The acoustic sensor can be configured to collect data within 1 to 2 seconds after detecting abdominal contraction. Figure 3 An example of the sensing signals collected and transmitted by the acoustic sensor 4 can be seen, which is activated by detecting abdominal contraction through the signal of the abdominal contraction sensor 3.

[0049] In a preferred embodiment of the invention, the sensing instrument unit 2 includes at least one body positioning and motion characterization sensor 9, adapted to collect and transmit raw sensing signals from the user's body orientation to the sensing instrument unit 2. Preferably, the body positioning and motion characterization sensor 9 is a triaxial accelerometer, adapted to additionally collect raw sensing signals from the user's movement and transmit them to the sensing instrument unit 2. The triaxial accelerometer can be used to acquire the patient's body orientation, such as lying down (recumbent) or standing, or other relevant positions, such as supine, prone, or lateral recumbent. The body positioning and motion characterization sensor 9 can also be used to characterize the user's body movements, such as detecting whether the user is standing, running, or engaging in other movements. Other examples of the body positioning and motion characterization sensor 9 include gyroscopes or other inertial measurement units.

[0050] In the most preferred embodiment of the present invention, the sensing instrument unit 2 includes an abdominal contraction sensor 3, preferably an electromyography sensor with a dual-electrode structure; an acoustic sensor 4, preferably a microphone; and a body positioning and motion characterization sensor 9, preferably a triaxial accelerometer.

[0051] In other embodiments of the invention, the sensing instrument unit 2 may include additional sensors, such as temperature sensor 11 or electrocardiogram sensor, wherein each sensor is adapted to collect the raw sensing signal and send it to the sensing instrument unit 2.

[0052] microcontroller In a preferred embodiment of the invention, the system firmware is responsible for providing functionality to the electronic components and includes a set of instructions that enable the microcontroller 1 to coordinate sensor data acquisition, data transmission, and / or recording, such as sensor signals from each sensor, namely the abdominal contraction sensor 3, the acoustic sensor 4, the body positioning and motion characterization sensor 9, the temperature sensor 11, and the electrocardiogram sensor, as well as other sensors, and is regulated by the sensing instrumentation unit 2. Furthermore, the firmware is responsible for allowing the integration of additional devices, as detailed below.

[0053] The activation step of the acoustic sensor 4 is performed by the acoustic sensor activation unit 44 included in the microcontroller 1. The activation of the sensor occurs only when the abdominal contraction sensor 3 detects abdominal contraction, and the acoustic sensor 4 only collects and transmits the raw sensing signal to the sensing instrument unit 2 when activated. This technical feature is a solution with unexpected technical effects, but it is not significant compared to known continuous audio recording systems in the prior art, and therefore cannot protect user privacy. Many users believe that existing devices for continuously recording audio signals have privacy-related problems, and considering that these devices access private conversations, this makes users unwilling or uncomfortable using them.

[0054] On the other hand, the activation of the acoustic sensor 4 in the system of the present invention only occurs when an abdominal contraction event actually occurs, which will also allow for a reduction in battery consumption associated with the operation of the system and a reduction in the space required for data storage.

[0055] In a preferred embodiment of the system of the present invention, the data acquisition unit 43 obtained by the sensing instrument unit acquires electromyography data at a sampling frequency of 1000Hz, audio data of 44100Hz, accelerometer data of 100Hz, temperature sensor data of 10Hz, and electrocardiogram sensor data of 300Hz.

[0056] Only when the abdominal contraction sensor 3 detects an abdominal contraction will the acoustic sensor activation unit 44, included in the microcontroller 1, acquire and effectively record data from the microphone of the integrated acoustic sensor 4 during sensor activation. This will be achieved through firmware of the microcontroller 1 for a system that monitors, characterizes, and evaluates a user's cough, which will include a real-time processing module for the abdominal contraction sensor signal, detecting the abdominal contraction and allowing audio to be acquired at set intervals, for example, approximately 1 to 2 seconds after the abdominal contraction.

[0057] like Figure 4 As shown, the algorithm of the acoustic sensor activation unit 44 includes starting to collect sensing signals 34 and samples 35 of sensing signals acquired by the abdominal contraction sensor, which are accumulated in the data buffer 36 of the abdominal contraction sensor. Then, it verifies whether the data buffer has reached a given number of samples, N37. If not, the samples 35 of sensing signals acquired by the abdominal contraction sensor are restored. If so, the algorithm processes data packets 39 to check if they contain abdominal contractions. In the case of using an electromyography sensor, this processing includes the application of a frequency domain digital filter, the Teager-Kaiser Energy (TKE) operator, and the calculation of the signal envelope. Other processing techniques can also be applied to other abdominal contraction sensors 3. Using the processed data, the algorithm is applied to detect abdominal contraction events 40, followed by a decision step 41 based on the detection of abdominal contraction events. If an abdominal contraction event has been detected, the acoustic sensor 42 is activated. Regardless of whether an abdominal contraction event has been detected, a data buffer cleanup operation 38 is performed, followed by the restoration of the samples 35 of sensing signals acquired by the abdominal contraction sensor. This process is repeated until the end of the specified monitoring period.

[0058] The microcontroller 1 acquires regulated signals from the active sensors of the sensing instrument unit 2, and these signals are transmitted to the data processing and analysis unit 5 for cough assessment.

[0059] Microcontroller 1 can be configured as Figure 6 The electronic module of the control system shown is configured to directly control the sensing instrument unit 2 and the data stream unit, which is selected from the group consisting of the data transmission and reception unit 17 and the data storage unit 18. In one preferred embodiment of the invention, a low-power microcontroller 1 with an advanced RISC machine (ARM) architecture is used.

[0060] In an embodiment of the present invention, the microcontroller 1 may also receive commands sent by the cough assessment data processing and analysis unit 5 through the data transmission and receiving unit 17. The commands may involve, for example, instructions to start or end the sensor data acquisition time.

[0061] Central module and portable devices According to various embodiments of the present invention, it will be apparent to those skilled in the art that the central module 16 of the system for monitoring, characterizing, and evaluating a user's cough may include any data transmission and reception unit 17. The data transmission and reception unit 17 may be an electronic unit adapted to transmit data to a cough assessment data processing and analysis unit 5, such as a Bluetooth module. Digital sensing signals may be transmitted via Bluetooth or Bluetooth Low Energy or other wireless data transmission technologies (such as using radio frequency range waves or via Wi-Fi) to a smartphone, computer, tablet, smartwatch, or any other computer device 13 that includes the cough assessment data processing and analysis unit 5.

[0062] In embodiments of the present invention, the system includes a data storage unit 18, which may be a memory card, such as an SD card. Data stored on the memory card can be downloaded to a computer device 13 including a data processing and analysis unit 5 for cough assessment, or can be downloaded to a server 14 or cloud computing 15 including the data processing and analysis unit 5 for cough assessment. Therefore, digital sensor signals stored on the memory card can be processed locally, i.e., sent to a smartphone, a local computer, or a tablet, and / or transmitted to a cloud computing platform (cloud) or server for remote processing over a network.

[0063] Data transfer and data storage options can occur simultaneously, for example, simultaneously recording to an SD card and transferring data to the data processing and analysis unit 5 for cough assessment.

[0064] In another preferred embodiment of the invention, the data processing and analysis unit 5 for cough assessment is included within the microcontroller 1 itself, wherein the system according to the invention includes a central module 16, including the microcontroller 1; and • At least one energy source 19; and • At least one data transmission and reception unit 17 is adapted to transmit data generated by the operation of a microcontroller 1, the microcontroller 1 controlling the data transmitted by the data transmission and reception unit 17, the data being transmitted via wired communication 21 or wireless communication protocol 22; Furthermore, the microcontroller 1 includes a data processing and analysis unit 5 for cough assessment.

[0065] In another embodiment, the data processing and analysis unit 5 for cough assessment is included within the microcontroller 1 itself; the system according to the invention includes a central module 16, which includes the microcontroller 1; and • At least one energy source 19; and • At least one data storage unit 18 is adapted to store data generated by the operation of a microcontroller 1, wherein the microcontroller 1 controls the data stored in the data storage unit 18; Furthermore, the microcontroller 1 includes a data processing and analysis unit 5 for cough assessment.

[0066] like Figure 7 As shown, in another embodiment, the data processing and analysis unit 5 for cough assessment is included within the microcontroller 1 itself. The system according to the invention includes a central module 16, which includes the microcontroller 1; and • At least one energy source 19; and At least one data transmission and reception unit 17 is adapted to transmit data generated by the operation of a microcontroller 1, the microcontroller 1 controlling the data transmitted by the data transmission and reception unit 17, the data being transmitted via wired communication 21 or wireless communication protocol 22; and • At least one data storage unit 18 is adapted to store data generated by the operation of a microcontroller 1, wherein the microcontroller 1 controls the data stored in the data storage unit 18; Furthermore, the microcontroller 1 includes a data processing and analysis unit 5 for cough assessment.

[0067] exist Figure 7 In the embodiment shown, the system is not linked to the operation of computer device 13, server 14, or cloud computing 15 because the data processing and analysis unit 5 for cough assessment is incorporated into the central module 16, or more precisely, into the microcontroller 1.

[0068] When the system according to the invention is incorporated into a portable device for monitoring, characterizing, and evaluating a user's cough, Figure 7 The illustrated embodiment is particularly advantageous, wherein the device includes a method for connecting to a user's body.

[0069] The attachment methods known in the prior art can be used on the device of the present invention, such as a grip clip that can be fitted / fixed to a waistband or waist pocket; or placed around the user's waist by means of a grip strap.

[0070] However, it will be apparent to those skilled in the art that the portable device according to the present invention also includes Figure 6 In the system embodiment shown, the central module 16 includes a microcontroller 1 adapted to receive sensing signals regulated by the sensing instrument unit 2, and a data processing and analysis unit 5 for cough assessment is included in a computer device 13, a server 14, or a cloud computing 15.

[0071] In other embodiments of the invention, the central module 16 may include a screen 23, such as a touch screen, adapted to display information and / or input commands, such as pausing during monitoring, user personal information, user anthropometric information, and flagged events, such as symptoms experienced by the user or medication taken, for the operation of the data processing and analysis unit 5 for cough assessment.

[0072] In other embodiments of the invention, the central module 16 may include one or more buttons to mark operational events of the data processing and analysis unit 5 for cough assessment, such as symptoms experienced by the user or medication taken.

[0073] In the device embodiment according to the present invention, using Figure 6 and Figure 7 The system shown, with its sensors namely abdominal contraction sensor 3, acoustic sensor 4, and body positioning and motion characterization sensor 9, originates from the housing (e.g., box) surrounding the portable device, is connected to the user via a combination of wired or wireless communication protocols.

[0074] In other preferred embodiments of the invention, such as Figure 8 and 9 As shown, the housing includes a miniature portable device in the form of an adhesive patch, also known as patch 24, which adheres to the user's body like an adhesive bandage. It incorporates integrated sensing instruments 2, namely an abdominal contraction sensor 3, such as an electromyography sensor, an acoustic sensor 4, and optionally, among other additional sensors, body positioning and motion characterization sensors 9, such as a triaxial accelerometer. The acoustic sensor 4 can be placed in an area of ​​the portable device that does not contact the user's skin to enhance the reception of acoustic signals. Alternatively, the acoustic sensor 4 can be decoupled from the patch and located externally thereon, where acoustic signals are acquired only when an abdominal contraction event occurs and transmitted to the central module 16 via one or more wires or a combination of wireless communication protocols.

[0075] The following describes it in more detail. Figures 6 to 9 The components of the central module 16 shown.

[0076] Energy source 19, such as one or more batteries, supplies all units of the central module 16 of the system for monitoring, characterizing, and assessing a user's cough. Preferably, the energy source will allow for an extended monitoring cycle of at least 24 hours. The batteries used in the system may be lithium batteries. Battery charging can be accomplished by methods known in the art, including via wired or inductive charging. It will be apparent to those skilled in the art that batteries known in the prior art can be used in the central module 16 of the present invention, in the same manner as other energy sources, such as those that collect thermoelectric energy, enhanced through contact with the user's body via the housing (pattern).

[0077] In a preferred embodiment, the central module 16 has a voltage and temperature regulator 20 that can be connected to a rechargeable energy source 19. The voltage regulator circuit is responsible for maintaining the circuit voltage at 3.3V, even if the voltage of the energy source 19 is higher than this value. When the voltage drops below 3.3V, the firmware-controlled microcontroller 1 automatically and safely shuts down the central module 16.

[0078] The voltage and temperature regulator 20, which houses the battery or cell, ensures safe conditions for monitoring, characterizing, and evaluating the user's cough system. Batteries or cells, such as those composed of lithium batteries, can be hazardous if exposed to extreme conditions. In particular, temperature fluctuations are one of the main causes of data loss within the battery. Therefore, the system for monitoring, characterizing, and evaluating the user's cough includes the voltage and temperature regulator 20 to prevent related problems. Finally, the charging circuit allows the user to charge the energy 19 of the system's central module 16 to monitor, characterize, and evaluate the user's cough. This circuit is responsible for maintaining the potential and constant current to properly charge the battery.

[0079] In this embodiment, the sensing instrument unit 2 is not coupled to the central module 16, and some components of the sensing instrument unit 2, such as the acoustic sensor 4, are also not coupled to the central module 16. Communication with the central module 16 will be conducted via wireless communication protocol 22, which means that the uncoupled components have their own power source. Additionally, the uncoupled components include adapted electronics for communication with the system of this invention.

[0080] In a preferred embodiment of the invention, the user performs monitoring, and during this period, digital sensing signals are transmitted via wireless communication protocol 22 so that the data processing and analysis unit 5 for cough assessment performs the method steps according to the invention on a network, for example on server 14 or in cloud computing 15.

[0081] Therefore, in embodiments of the present invention, the system of the present invention can be used to perform monitoring, characterization and evaluation of a user's cough via telemedicine, wherein data and cough patterns are transmitted to a remote location via a wireless communication protocol.

[0082] The system according to the invention may also include a computer clock, which can be used to schedule monitoring sessions, such as starting and / or ending the acquisition of sensor data.

[0083] The system according to the invention may also include a decoupling subsystem, which, in terms of security, is apparent to those skilled in the art in cases where a user monitors themselves with a device connected to the current.

[0084] The system according to the invention can also be inserted into a waterproof unit, which is particularly advantageous, allowing users to truly use the device in a fully ergonomic manner and continue their normal lives, for example, without interrupting data collection during showering.

[0085] Synchronize with external devices In addition to the integration of additional sensors, this invention is characterized by a method of synchronization with external devices, enabling the data processing and analysis unit 5 for cough assessment to detect patterns based on potential causes of cough events. Similar to the integration of additional sensors, synchronization with external devices provides a more complete framework for generating patterns associated with user cough events, such as causal patterns. In even more preferred embodiments, the data processing and analysis unit 5 for cough assessment monitors, characterizes, and evaluates additional cough patterns based on data obtained through synchronization with other external devices.

[0086] In a preferred embodiment of the invention, the system can be synchronized with pH measuring device 12. Specifically, synchronization with the pH measuring device allows for the establishment of a possible causal model between cough and gastroesophageal reflux, in order to understand whether the cough event primarily causes the reflux or the reflux episode causes the cough.

[0087] In a preferred embodiment of the invention, the microcontroller 1 is responsible for synchronizing with other external devices. In one embodiment, synchronization can be achieved via a synchronization signal, which can be transmitted to the external device via wired communication 21 or wireless communication protocol 22. In this embodiment, the same synchronization signal is transmitted via a data stream unit to the data processing and analysis unit 5 for cough assessment. In the same embodiment, the external devices operate in parallel and independently, and the sensor signals of the two devices are time-aligned in the data processing and analysis unit 5 for cough assessment by time alignment of the synchronization signal.

[0088] In another embodiment, the system of the present invention can be synchronized with an external device by means of the internal clock of the microcontroller or data transmission and reception unit (i.e., Bluetooth module) of the synchronizing device.

[0089] Alternatively, in another embodiment, a computer program can be used to synchronize the devices. In one embodiment, the computer program is responsible for sending synchronization events to the two devices, thereby allowing later synchronization on the data processing and analysis unit 5 for cough assessment based on the synchronization events.

[0090] like Figure 15As shown, the system of the present invention can be synchronized with external devices, such as pH measuring device 12. In the illustrated embodiment, the device of the present invention captures signals of abdominal contractions, i.e., via an electromyography sensor, and captures audio signals, i.e., via an omnidirectional microphone, after activation by an acoustic sensor activation unit included in the microcontroller 1. Simultaneously, the external pH measuring device captures pH measurement signals at the pharyngeal and esophageal levels. Figure 15 As shown, the device of the present invention synchronizes with an external device by sending a synchronization signal (e.g., a step function) received from the external device. The synchronization signal has the function of establishing aligned time frames for joint analysis of sensor data from different devices involved in the monitoring, characterization, and evaluation of a user's cough. Subsequently, the data processing and analysis unit 5 for cough evaluation aligns the time of the digital sensor signals from the two devices based on the time alignment of the synchronization signal. After signal alignment from the two devices, the data processing and analysis unit 5 for cough evaluation processes and analyzes the sensor signals from the two devices and establishes a causal relationship pattern between cough and associated gastroesophageal reflux attacks.

[0091] System Fault Unit like Figure 11 and 12 As shown, the system according to the present invention can present the fault detection function of the system itself through the sensor instrument unit fault detection unit 27. Figure 11 and Figure 12 The data shows anomalies in the data acquisition of the abdominal contraction sensor 3. These anomalies can be detected in the microcontroller's firmware using code to detect whether the signal has values ​​or characteristics associated with a system fault. Specifically, Figure 11 This is an example of an electromyography (EMG) sensor no longer in contact with the user's skin. Specifically, Figure 12 One example is an electromyography (EMG) sensor, specifically the electrodes, which cannot properly contact the user's skin due to their high hair density.

[0092] Another embodiment of the fault detection unit may include the digital output of an electromyography sensor, which can indicate whether the sensor is making proper contact with the skin.

[0093] Processing and analysis of cough assessment data In a preferred embodiment of the invention, the sensing signals obtained by the sensing instrument unit 2 and external devices are processed by a computer program running in the data processing and analysis unit 5 for cough assessment, to continue monitoring, characterizing, and evaluating the user's cough. In particular, the system of the present invention allows for objective analysis of the user's cough by establishing parameterized cough patterns involving frequency, cough type, the user's body position, and other supplementary data regarding the causes of the cough event. In addition to using various automated learning algorithms (machine learning) and artificial intelligence, the computer program also uses sensor signal processing techniques to analyze, process, and classify digital sensor data.

[0094] The data processed and analyzed by the data processing and analysis unit 5 for cough assessment includes the following data and combinations thereof: • Digital sensing signals obtained from sensing instrument unit 2, including signals obtained from external sensing instrument unit 25; • Digital sensing signals obtained from external devices; • Digital sensing signals generated by microcontroller 1; • Digital sensing signals transmitted by the data transmission and reception unit 17; • Digital sensing signals stored in data storage unit 18; • Anthropometric data, especially those input via screen 23; • Personal data, such as variables related to gender and age, can be entered using screen 23; • Other events recorded by the user, such as symptoms experienced by the user; and • Synchronous input, such as a synchronization signal.

[0095] The electromyography sensor, through the action of the data processing and analysis unit 5 for cough assessment, allows for the detection of cough events, and can also utilize combined action with the acoustic sensor 4, such as a microphone, to improve the performance of the cough detection algorithm, i.e., reduce the false positive rate. However, in other embodiments of the invention, the detection of abdominal contraction events may not depend on the audio signal; that is, it may be accomplished solely through the processing of the abdominal contraction sensor signal 3 by the data processing and analysis unit 5 for cough assessment.

[0096] The acoustic signal, through the action of the data processing and analysis unit 5 for cough assessment, allows for characterization of the type of cough. Signals from abdominal contraction events can also be used to characterize the type of cough. In one embodiment of the invention, cough can be classified as dry cough and cough with excessive phlegm. In another embodiment, the data processing and analysis unit 5 for cough assessment can also detect other additional characteristics of the cough, such as whether the cough is accompanied by wheezing.

[0097] Regarding the types of cough patterns established by this invention, such as Figure 13 As shown, the system of the present invention can detect cough patterns, such as a nighttime dry cough pattern based on the use of electromyography sensor 3 and sound sensor 4.

[0098] User anthropometric information (such as weight, height, and age) can also be detected and characterized by the data processing and analysis unit 5 used for cough assessment.

[0099] In a preferred embodiment of the invention, the data processing and analysis unit 5 for cough assessment evaluates additional cough patterns based on data from the supplementary body positioning and motion characterization sensor 9. Figure 14 For example, the pattern shown indicates that a coughing attack is triggered by a lying (reclining) posture.

[0100] In a more preferred embodiment, the data processing and analysis unit 5 for cough assessment monitors, characterizes, and evaluates additional cough patterns based on data from additional sensors and external devices, providing data about the events that trigger coughing. In a preferred embodiment, the data processing and analysis unit 5 for cough assessment allows for time alignment of data obtained through the sensing instrument unit 2 with data from external devices, as described in more detail previously.

[0101] The sensing signals collected by the electromyography sensor located in the user's abdominal region include artifacts corresponding to signals generated by the heartbeat. The data processing and analysis unit 5 for cough assessment can be configured to detect cough events by filtering and discarding signals from the heartbeat. However, the filtered and discarded heartbeat signals can be displayed and processed. Therefore, as... Figure 5 As shown, the system according to the invention also allows for monitoring of the user's heart rate. On the other hand, in order to detect heartbeats with altered morphology, such as premature ventricular contractions, an additional electrocardiogram sensor can be incorporated in other embodiments of the invention. Signals from the sensor can also be processed by the cough assessment data processing and analysis unit 5 to generate additional cough patterns associated with cardiovascular problems.

[0102] In one embodiment of the invention, the automatic learning algorithm can use data about the frequency and type of coughs to detect cough patterns, such as nighttime cough patterns, etc. Figure 13 As shown, and information data about events that trigger coughing, such as coughing triggered by lying down, such as... Figure 14 As shown, coughs can be triggered by physical exercise or by sudden temperature changes.

[0103] In one embodiment of the invention, the type of algorithm and machine learning characteristics, regarding the system for monitoring, characterizing and evaluating a user's cough, the range of automatically learning classifiers can be from simple decision trees and k nearest neighbor classifiers to complex neural networks and deep learning algorithms.

[0104] Preferably, the data processing and analysis unit 5 for cough assessment automatically learns algorithms to combine relevant characteristics extracted from signals obtained by the sensing instrument unit 2 and external devices, or possibly a set of raw sensing signals, to allow for quantitative and qualitative cough characterization.

[0105] User anthropometric information such as weight, height, and age can also be used to detect cough events and the type of cough.

[0106] In embodiments of the invention, data marking events, even using a screen installed in the system of the invention, can be used to detect cough patterns. Specifically, a pattern of heart palpitations felt by the user before a cough attack can be detected, which may indicate an association between the cough and cardiovascular problems.

[0107] In a preferred embodiment of the invention, the data processing and analysis unit 5 for cough assessment includes instructions read by a computer, which can be executed on a computer device 13, a server 14, a cloud computing platform 15, or a microcontroller 1.

[0108] The computer program included in the data processing and analysis unit 5 for cough assessment can be executed locally by running directly on the computer device 13. In a preferred embodiment of the invention, the computer device 13 includes the data processing and analysis unit 5 for cough assessment, and the computer device 13 may be a computer, such as a local computer, smartphone, smartwatch, or tablet. Alternatively, such a computer program may run online. In this embodiment, digital sensor data is transmitted to and processed in a server 14 or cloud computing 15. Therefore, the server 14 or cloud computing 15 may include the data processing and analysis unit 5 for cough assessment.

[0109] In a preferred embodiment, the data processing and analysis unit 5 for cough assessment is included in a computer device 13, server 14, or cloud computing 15; the system according to the invention includes a central module 16, including a microcontroller 1; and • At least one energy source 19; and • At least one data transmission and reception unit 17 is adapted to transmit data generated by the operation of a microcontroller 1, the microcontroller 1 controlling the data transmission of the data transmission and reception unit 17, the data being transmitted via wired communication 21 or via wireless communication protocol 22; Furthermore, the data processing and analysis unit 5 for cough assessment processes and analyzes the data transmitted by the data transmission and reception unit 17.

[0110] Alternatively, in a preferred embodiment, the data processing and analysis unit 5 for cough assessment is included in a computer device 13, server 14, or cloud computing 15; the system according to the invention includes a central module 16 comprising a microcontroller 1; and: • At least one energy source 19; and • At least one data storage unit 18 is adapted to store data generated by the operation of a microcontroller 1, wherein the microcontroller 1 controls the data storage unit 18 to store the data; Furthermore, the data processing and analysis unit 5 for cough assessment processes and analyzes the data stored in the data storage unit 18.

[0111] Or, such as Figure 6 As shown, in a preferred embodiment, the data processing and analysis unit 5 for cough assessment is included in a computer device 13, server 14, or cloud computing 15. The system according to the invention includes a central module 16, including a microcontroller 1, and... • At least one energy source 19; and At least one data transmission and reception unit 17 is adapted to transmit data generated by the operation of a microcontroller 1, the microcontroller 1 controlling the data transmitted by the data transmission and reception unit 17, the data being transmitted via wired communication 21 or via wireless communication protocol 22; and • At least one data storage unit 18 is adapted to store data generated by the operation of a microcontroller 1, wherein the microcontroller 1 controls the data stored in the data storage unit 18; Furthermore, the data processing and analysis unit 5 for cough assessment processes and analyzes the data transmitted by the data transmission and reception unit 17 and the data stored in the data storage unit 18.

[0112] In an embodiment of the invention, the data processing and analysis unit 5 for cough assessment can send commands to the data transmission and receiving unit 17, the commands of which may involve instructions, for example, to start or end the sensor data acquisition time.

[0113] like Figure 10As shown, the functional block diagram of the present invention includes receiving abdominal contraction data 28 by an abdominal contraction sensor 3 (e.g., an electromyography sensor); receiving audio signals 29 by an acoustic sensor 4 including a microphone only moment after an abdominal contraction event, for example, receiving user body position and motion input data 30 by a body positioning and motion characterization sensor 9 (e.g., a triaxial accelerometer); and receiving a dataset 31 from external sensors by an external sensing instrument unit 25. During acquisition, when the abdominal contraction sensor 3 detects an abdominal contraction event, the microcontroller 1 controls the activation of the acoustic sensor 4 via the acoustic sensor activation unit 44. The digital sensing data obtained by the microcontroller 1 is sent to a data processing and analysis unit 5 for cough assessment, which includes a signal processing module and may also include an automatic machine learning classification module. In addition to the sensing data obtained by the sensing instrument unit 2 and the external instrument unit, the data processing and analysis unit 5 for cough assessment may also receive at least one anthropometric input information 32 and at least one set of data 45 from a synchronized external device. After processing, the data processing and analysis unit 5 for cough assessment presents a set of output information 33 based on the specified cough monitoring period: the frequency and type of cough events; and parameterized cough patterns involving the user's frequency, cough type, body position and movement, as well as other supplementary data about the triggering cough events.

[0114] In the first step, the data processing and analysis unit 5 for cough assessment modulates the signal from the abdominal contraction sensor to remove artifacts, namely network noise (50Hz or 60Hz) and other artifacts. The processing steps performed by the data processing and analysis unit 5 for cough assessment include using digital filters in the frequency domain, such as low-pass, band-pass, and band-stop filters. Furthermore, the data processing and analysis unit 5 for cough assessment removes or attenuates heartbeats present in the signal from the electromyography sensor. This signal purification can be performed using various signal processing algorithms, such as filters in the frequency domain and dynamic filtering using Savitzky-Golay filters. Finally, after this step, the Teager-Kaiser operator is applied to increase the signal-to-noise ratio between muscle activation and baseline.

[0115] The processing performed by the data processing and analysis unit 5 for cough assessment also includes an abdominal contraction event identification step, which aims to detect all possible abdominal contractions, regardless of whether they are caused by a cough event, as the automatic learning step will later distinguish the activations that actually correspond to a cough. In this way, this step will be optimized to detect all abdominal activations to ensure that no cough event is missed. Additionally, for the electromyography sensor, the processing performed by the data processing and analysis unit 5 for cough assessment may include: a signal filtering step with a moving average filter to smooth the signal and facilitate the detection of activations of abdominal contraction events; and a phase for detecting and characterizing activations, namely, detecting the start and end of activations through a dynamic threshold that will be adjusted according to the signal segment to be analyzed.

[0116] After identifying and depicting abdominal contractions, the data processing and analysis unit 5 for cough assessment uses the signal to extract features, which will be used by an automated learning algorithm. The extracted features include: activation duration, area, and maximum amplitude, as well as other features in the time, frequency, and time-frequency domains (wavelets).

[0117] The audio signal processed by the data processing and analysis unit 5 for cough assessment runs an audio extract recorded by a computer program adapted to perform the steps of the method according to the invention, corresponding to the activation of the acoustic sensor activation unit 44, with the aim of obtaining the audio only moment after abdominal contraction. In a preferred embodiment of the invention, the data processing and analysis unit 5 for cough assessment includes a preprocessing step of the audio extract to remove artifacts. Features can then be extracted using the signal fragments, similar to the work done on the signal emitted by the abdominal contraction sensor 3, and the automatic learning algorithm will use these features. Alternatively, the signal fragments can be used directly by the automatic learning algorithm.

[0118] In a preferred embodiment of the invention, the additional sensor can be coupled to the sensing instrument unit. However, considering its independent operation, the external device must be synchronized with the system of the invention. Furthermore, the external device can send data to the data processing and analysis unit 5 used for cough assessment.

[0119] In another embodiment of the invention, a data processing and analysis unit 5 for cough assessment receives additional sensing signals from additional sensors or external devices. This unit is also responsible for processing the data from the external sensors or devices and ultimately detecting patterns based on that data. These additional patterns that trigger cough events provide a more complete picture of pattern generation associated with user cough events.

[0120] As used in this specification, the expression "in contact with the user's body" or "in contact with the user's body" means that the sensor or device is located on the user's skin, i.e., in the abdominal or upper abdominal area.

[0121] As used in this specification, the expression "close to the user" or "close to the user's body" means that the sensor or device is located at a distance from the user, allowing the sensor or device to operate effectively.

[0122] As used in this specification, the terms “about” and “approximately” refer to a range of plus or minus 10% of the specified number.

[0123] As used in this specification, the expression "substantially" means that the actual value is within about 10% of the expected value, variable, or related limit, particularly within about 5% of the expected value, variable, or related limit, or particularly within about 1% of the expected value, variable, or related limit.

[0124] The subject matter described above is illustrative of the invention and should not be construed as limiting the invention. The terminology used to describe specific embodiments of the invention should not be construed as limiting the invention. As used in the specification, the singular form is defined and undefined articles are also intended to include the plural form, unless the context of the specification clearly indicates otherwise. It should be understood that, when used in this specification, the terms "comprising" and "including" specify the presence of features, elements, components, stages, and associated operations, but do not exclude the possibility of including other features, elements, components, stages, and operations.

[0125] All variations, as long as they do not modify the essential features of the claims, should be considered within the scope of protection of this invention.

[0126] Reference Symbol List 1. Microcontroller; 2. Sensing and detection unit; 3. Abdominal contraction sensor; 4. Acoustic sensor; 5. Data processing and analysis unit for cough assessment; 6. Surface electrode; 7. The upper electrode of the surface electromyography sensor; 8. The lower electrode of the surface electromyography sensor; 9. Human body positioning and motion characterization sensors; 10. Metasurface electromyography sensor; 11. Temperature sensor; 12. pH measuring equipment; 13. Computer equipment; 14. - Server; 15. Cloud computing; 16. Central Module; 17. - Data transmission and reception unit; 18. - Data storage unit; 19. - Energy; 20. Voltage and temperature regulators; 21. Wired communication; 22. Wireless communication protocol; 23. - Screen; 24. - Patch; 25. - External sensing instrument unit; 26. Waterproof unit; 27. Fault detection unit for sensing instruments; 28. - Receive abdominal contraction data; 29. - Receive audio signals only moment after an abdominal contraction event; 30. - Receive input data on the user's body location and movement; 31. External sensor dataset; 32. Input information for human body measurements; 33. - A set of output information; 34. - Begin collecting sensor signals; 35. Samples of sensing signals acquired by the abdominal contraction sensor; 36. The abdominal contraction sensor accumulates samples of the sensing signals into the data buffer of the abdominal contraction sensor; 37. - Verify that the data packet has reached the given number of samples; 38. Data buffer cleanup operation; 39. Data buffer processing; 40. Applying algorithms to detect abdominal contraction events; 41. - Decision steps based on detecting abdominal contraction events; 42. - Activate the sound sensor; 43. - Data acquisition unit obtained from the sensing instrument unit; 44. - Acoustic sensor activation unit (44); and 45. - Data set from an external synchronization device (45).

Claims

1. A system for monitoring, characterizing, and evaluating a user's cough, characterized in that, The sensor unit (2) includes: An abdominal contraction sensor (3) adapted to contact the user's body; the abdominal contraction sensor (3) is a surface electromyography sensor with a two-electrode configuration; and At least one acoustic sensor (4) is adapted to be close to the user; At least one body positioning and motion characterization sensor (9) is adapted to acquire and transmit raw sensing signals to the sensing instrument unit (2); The abdominal contraction sensor (3) is configured to collect and transmit raw sensing signals to the sensing instrument unit (2). The acoustic sensor (4) is configured to collect and transmit raw sensing signals to the sensing instrument unit (2) in the active state. The sensing instrument unit (2) adjusts the signals of the abdominal contraction sensor (3), the acoustic sensor (4) in the activated state, and the body positioning and motion characterization sensor (9). The body positioning and motion characterization sensor (9) is a triaxial accelerometer or gyroscope; The system also includes a microcontroller (1), which includes: The data acquisition unit (43) acquires the data obtained by the sensing instrument unit (2); and the data acquisition unit (43) acquires the data obtained by the sensing instrument unit (2); and The acoustic sensor activation unit (44) activates the acoustic sensor (4) only when an abdominal contraction is detected on a signal obtained from the abdominal contraction sensor (3), and the acoustic sensor (4) only collects and transmits raw sensing signals to the sensing instrument unit (2) when activated; wherein the acoustic sensor activation unit (44) executes the acoustic sensor activation unit algorithm, which is configured to detect an abdominal contraction event when the number of sensing signal samples in the data buffer of the abdominal contraction sensor (3) reaches a given number; The data acquisition unit (43) and the acoustic sensor activation unit (44) are interconnected; wherein the data acquisition unit (43) is configured to perform data acquisition from the acoustic sensor (4) only when the acoustic sensor activation unit (44) activates the acoustic sensor (4); The system further includes at least one data flow unit selected from the group consisting of a data transmission and reception unit (17) and a data storage unit (18), wherein the data flow unit is controlled by a microcontroller (1); The system also includes a data processing and analysis unit (5) for cough assessment, configured to process and analyze data generated by the operation of the microcontroller (1) and monitor, characterize and assess the user’s cough, wherein the data processing and analysis unit (5) for cough assessment is configured to use sensor signal processing, machine learning algorithms to analyze, process and classify digital sensor data; The data processing and analysis unit (5) for cough assessment is configured to detect cough events, characterize cough types, and establish parameterized cough patterns, which involve potential causal cough events involving frequency, cough type, user body position, and other additional data, wherein the body positioning and motion characterization sensor (9) is configured to detect potential causal cough events.

2. The system for monitoring, characterizing, and evaluating a user's cough according to claim 1, characterized in that, The sensing instrument unit (2) includes a connection to one or more external sensing instrument units (25); the external sensing instrument units are selected from temperature sensors and electrocardiogram sensors, and the system for monitoring, characterizing and evaluating a user’s cough is configured to be synchronized with the external sensing instrument unit (25).

3. The system for monitoring, characterizing, and evaluating a user's cough according to any one of the preceding claims, characterized in that, It includes a central module (16), which includes a microcontroller (1), at least one power source (19), at least one data transmission and reception unit (17), and at least one data storage unit (18). The data transmission and reception unit (17) is adapted to transmit data generated by the operation of a microcontroller (1), the microcontroller (1) controlling the data transmitted by the data transmission and reception unit (17), the data being transmitted via wired communication (21) or via a wireless communication protocol (22); and The data storage unit (18) is adapted to store data generated by the operation of the microcontroller (1), and the microcontroller (1) controls the data stored in the data storage unit (18); The data processing and analysis unit (5) for cough assessment processes and analyzes the data transmitted by the data transmission and reception unit (17) and the data stored in the data storage unit (18).

4. The system for monitoring, characterizing, and evaluating a user's cough according to claim 1, characterized in that, It includes a central module (16), which includes a microcontroller (1), at least one power source (19), at least one data transmission and reception unit (17), and at least one data storage unit (18). The data transmission and reception unit (17) is adapted to transmit data obtained by a microcontroller (1), the microcontroller (1) controlling the data transmitted by the data transmission and reception unit (17), the data being transmitted via wired communication (21) or via a wireless communication protocol (22); and The data storage unit (18) is adapted to store data obtained by the microcontroller (1), and the microcontroller (1) controls the data stored in the data storage unit (18).

5. A method for monitoring, characterizing, and evaluating a user's cough, applied to the system according to any one of claims 1 to 4, characterized in that, The method includes the following steps: i. An abdominal contraction sensor (3) included in the sensing instrument unit (2) is in contact with the user's body; the abdominal contraction sensor (3) is a surface electromyography sensor with a two-electrode configuration; ii. Bring at least one acoustic sensor (4) included in the sensing instrument unit (2) close to the user's body; iii. The raw sensing signal is transmitted from the active sensor to the sensing instrument unit (2), the active sensor including an abdominal contraction sensor (3), an acoustic sensor (4) and a body positioning and motion characterization sensor (9), the body positioning and motion characterization sensor (9) being a triaxial accelerometer or a gyroscope; iv. The signals of the abdominal contraction sensor (3) and the acoustic sensor (4) in the activated state, as well as the signal of the body positioning and motion characterization sensor (9), are adjusted by the sensing instrument unit (2); v. The acquisition of data obtained by the sensing instrument unit (2) is controlled by a microcontroller (1); vi. The microcontroller (1) controls the activation of the acoustic sensor (4) only when the abdominal contraction sensor (3) detects abdominal contraction. When the acoustic sensor (4) is activated, the original sensing signal is collected and transmitted to the sensing instrument unit (2). The acoustic sensor activation unit (44) executes the acoustic sensor activation unit algorithm. When the number of sensing signal samples in the data buffer of the abdominal contraction sensor (3) reaches a given number, the abdominal contraction event is detected. vii. Data is received by the data processing and analysis unit (5) for cough assessment; viii. The user's cough is monitored, characterized, and evaluated by a data processing and analysis unit (5) for cough assessment; wherein the data processing and analysis unit (5) for cough assessment uses sensor signal processing and machine learning algorithms to analyze, process, and classify digital sensor data; The data processing and analysis unit (5) for cough assessment detects cough events, characterizes cough types, and establishes parameterized cough patterns, which involve potential causal cough events involving frequency, cough type, user body position, and other additional data, wherein the body positioning and motion characterization sensor (9) detects potential causal cough events.

6. The method for monitoring, characterizing, and evaluating a user's cough according to claim 5, characterized in that, The sensing instrument unit (2) also receives raw sensing signals from the body positioning and motion characterization sensor (9) and modulates the sensing signals through the following additional steps: i. The body positioning and motion characterization sensor (9) included in the sensing instrument unit (2) comes into contact with the user's body; ii. Body positioning and motion characterization sensor (9) collects raw sensing signals and transmits them to the sensing instrument unit (2).

7. The method for monitoring, characterizing, and evaluating a user's cough according to claim 5 or 6, characterized in that, One or more external sensing instrument units (25) are connected to a system for monitoring, characterizing and evaluating a user’s cough.

8. The method for monitoring, characterizing, and evaluating a user's cough according to claim 5, characterized in that, The process of the surface electromyography sensor coming into contact with the user's body includes the following steps: i. The upper electrode (7) of the surface electromyography sensor is in contact with the user's body below the xiphoid process of the sternum and above the linea alba. ii. Place the lower electrode (8) of the surface electromyography sensor on an imaginary line containing the upper electrode (7), parallel to the costal margin, at the rectus abdominis muscle in the upper abdomen; iii. Apply additional electrodes to the bone-dominant area that comes into contact with the user's body.

9. A portable device for monitoring, characterizing, and evaluating a user's cough, characterized in that, The system includes any one of claims 1 to 4, wherein the device is attached to the user's body.

10. A computer device, characterized in that, It consists of a processor configured to perform one or more steps of the method according to any one of claims 5 to 8.

Images