NL1044817B1 - Biological information measurement equipment with multi-sensor monitoring device and respiratory problem alarms - Google Patents

Abstract

The present disclosure relates to a wearable garment having respiration monitoring capabilities, a system comprising the garment, and related computer-implemented methods carried out by the system. The garment employs an array of sensors, comprising circumference measuring strain sensors and one or more of: ECG sensors, an SPO2 sensor, skin conductivity sensors, body temperature sensors, motion sensors, load sensors and a monitoring controller communicating with said sensors. The sensors collect data for determining changes in upper body circumference and one or more of: electrocardiogram data, body temperature, skin conductivity and peripheral oxygen saturation of the wearer in order to detect patterns in the respiratory behaviour to determine the presence or imminence of episodes of respirational disorder. At the same time, the controllers detect motion and load of the garment and use these to discriminate invalid data sent to the monitoring controller.

Description

TITLE

BIOLOGICAL INFORMATION MEASUREMENT EQUIPMENT WITH MULTI-

SENSOR MONITORING DEVICE AND RESPIRATORY PROBLEM ALARMS

FIELD OF THE INVENTION

The present invention generally relates to the field of medical devices and monitoring equipment. More specifically, the invention relates to a garment and related methods for measuring biological information for the determination of respiratory events and patterns in users,

CROSS REFERENCE

The present gpplication claims priority as a continuation of NL patent application No. 1044714, filed October 16, 2023.

RELATED ART

Measurement of physiological signals to determine biological information relating to respiratory activity has long been known and widely used for medical and health related applications. Generally, such measurements are conducted using a monitoring controller, connected with biometric sensors, measuring changes in body circumference at the locations of abdominal and costal muscles. Various monitoring controllers connected with sensors on belt- type pick-ups have been described in publications {e.g.. University of Paraná, Brazil, 2019:

Breathing Monitoring and Pattern Recognition with Wearable Sensors} and patents (e.g.,

EPOIRES08ATL, 1985, apparatus for determining the respiratory behaviour of a patient;

EP1731094A 1, 2005, Garment with a respiratory information analysis device; 253 WO20081393S80A2, 2008, system and method for guiding breathing exercises).

Even in conventional art, such arrangements of controllers, sensors and pick-ups are generally combined in a belt or garment of elastic materials, as to fit tightly to the user’s upper body. The terms “a wearable” and “wearable sensors” are now commonly used to describe such arrangements. Alternatively, in conventional art, the sensors and pick-ups are placed on the user's body by a trained medical professional by means of belts, suction cups, sticky tape, and clips. With these features, the biological information gathering devices can acquire data that represents respiratory information.

In conventional art the presentation of actual respiratory information by means of a computer display device represents the current respiration of the user, This information is considered relevant for medical professionals and users trained in interpreting this information,

As such it will confirm and detail signs of the user's respiration and may provide insight into the user's present condition. Also, comparing the actual respiratory information against thresholds set in the monitoring controller provides a means ta alarm the user, or persons either in the vicinity of the monitoring controller or remotely connected to the monitoring controller, that this person or the user might need to pay attention to the condition,

The acquisition of the biological information by means of conventional wearable sensors imposes large limitations to the user's freedom of mobility, position, attitude, and posture. More specifically, measurements taken by conventional wearable sensors are highly affected by the accurate positioning of the sensors on the user's body, and by the motion, position, attitude, condition, and posture of the user. Such measurements require the users to limit their movements to reduce interference with the measurements or re-fit and re-adjust the wearable sensors depending on activity and position and thus can only be used under controlled circumstances, or for a single specific purpose, or over short periods of time. Current mechanisms for the acquisition of actual respiratory information are, however, known ic be prone to damage from overstretching during dressing, fitting and adjustment. Accuracy of current mechanisms for the acquisition, measurements and presentation of actual respiratory information using strain sensors are known to be insensitive and inaccurate because of low resolution and signal amplitude, and system noise.

Current mechanisms for the measurement and presentation of actual respiratory information hinder the detection of the progression of atiributes of the acquired data that could provide relevant information about the change of the user’s condition or that could indicate the imminence of an episode of respiratory issues, These limitations restrict medical experts in the determination of vital breathing pattern information and limit users’ possibilities to prevent such 253 episodes and its consequences. Also, presenting the actual respiration information makes the user aware of the measurements being taken, while user's awareness of measurements being taken is known to influence the user's behaviour to such an extent that the measurements may be impacted, even cancelling out the symptoms looked for.

Presentation of actual respiratory information during a period in which a user is experiencing the symptoms of an episode of an intermittent respiratory issue does not help the user to prevent or control the respiratory problem,

Information provided by wearable respiration sensors helps represent breathing behaviour and can help document respirational issues based on patterns, frequency, and amplitude of breathing. Once detected, this information serves no purpose in predicting and preventing episodes of respirational problems.

It would thus be desirable to provide improved wearable sensors with the objective to provide biological measurements that overcome the limitations of conventional art, Limitations of weargble sensors and controllers in conventional art that the present invention assists in overcoming include: the lack of means of such to record breathing patterns under changing conditions or over prolonged periods of time; the lack of means to objectively determine changes in levels of arousal or increasing levels of discomfort leading up to an episode of respirational problems; the consequent lack of means to detect impending episodes of respiratory issues; the limitation imposed by the low sensitivity, low resolution and fragility of the sensors; the lack of means to help the user prevent and control the then emerging respiratory problems and, hence, the symptoms of such episodes.

It is within this context that the present invention is set,

IS SUMMARY OF THE INVENTION

The present disclosure provides a wearable sensor garment, a set of sensors, and one or more controllers for measuring biological data relating to the user's respiratory behaviour and related vital signs.

The garment is configured to be worn over the torso of a user and to measure, via the sensors and the one or more controllers, changes in upper body circumference, heartbeat signals, body temperature, perspiration, and peripheral capillary oxygen saturation. The garment itself may be formed of an elastic, non-conductive material.

In some embodiments, the garment comprises an array of eight or more strain sensors, distributed evenly vertically over the garment and positioned so as to align with the area from the user's abdominal muscles to the location of the user's costal muscles. These sensors change their electrical characteristics according to mechanical tension transferred to them as a consequence of changes in upper body circumference as a result of the user's breathing and are configured to deliver the electrical signals that represent the changes in body circamference io a monitoring controller,

In some embodiments, the garment comprises one or more additional strain sensors, positioned so as to change their electrical characteristics as a consequence of forces applied from body movements of the user, configured to delivering the electrical signals that represent the changes in external load to a monitoring controller,

In some embodiments, the garment comprises a first array of conductive patches. The patches may be positioned on an inner surface of the garment so as to align with locations where the electrical signal of the heartbeat can be picked up when the garment is worn. The paiches are coupled with a processor configured to process the electrical potential of each of these patches, thus providing a high-resolution ECG data stream to a monitoring controller.

In some embodiments, the garment comprises a second set of two or more conductive patches, positioned on an inner surface of the garment so as to align with the vser’s right shoulder blade when worn, the patches being configured to configured to measure the electrical resistance between respective points on the wearers skin and to deliver the electrical signals that represent the skin resistance to a monitoring controller.

In some embodiments, the garment comprises a thermometer device, located in the garment so as to rest adjacent to the right armpit of the user, that changes its electrical characteristics as a consequence of the temperature of the armpit, and which is configured to deliver the electrical signals that represent the armpit’s temperature to a monitoring controller. in some embodiments, the garment comprises an inertial measurement anti, configured to deliver a stream: of data that represents its orientation and movement to a monitoring controller,

The inertial measurement unit may be further configured to capture user input by means of detecting taps on the monitoring controller’s casing, thereby providing a means to the user to signal the control processor of any meaningful event relating to the respiratory issue being 29 monitored,

In some embodiments, the garment comprises a peripheral capillary oxygen saturation sensor, conunonly referred to as an SPO2 sensor, that is equipped with sensors configured to detect and deliver oxygen saturation data to a monitoring controller, the data representing the peripheral capillary oxygen saturation of the user, The peripheral capillary oxygen saturation sensor may be provided as a clip configured to attach to the user's index finger, or placed on other locations on the user's body in an appropriate way, suitable to obtains the desired measurements, - The garment comprises at least one monitoring controller, The monitoring controller or monitoring controllers may be configured to deliver the signals received via one or more sensors by means of data transfer equipment to a portable computer device containing software configured to store, interpret, and present the signals,

The disclosed garment may be part of a system comprising one or more of said garments, one or more user devices, one or more monitors, one or more alarm devices, one or more, and one or more networked servers or processing devices, The system may be configured te carry ont a number of computer-implemented methods using the sensor data acquired by the one or more ganments.

Thus, according to another aspect of the present disclosure, there is provided a system and computer-implemented method for interpreting sensor data collected by the disclosed garment 5 apparatus. The method may comprise the following steps: a) receive, store, report and display the acquired data, b) determine and detect patterns in the acquired data that may predict the imminence of an episode of respiratory issues, to alarm the user of such imminence by means of an audible and sensory alarm, and to issue suggestions for means of exercises Io prevent or mitigate such episodes, c) connect the user monitor to the monitoring controller and t5 a computer system containing one or mote processors and storage devices, configured to run logic that stores and analyses the biological data from multiple connected users.

With these features, the biological information measurement equipment with multi-sensor monitoring device can be worn over extensive periods of time with the user practically unaware of its presence, acquire accurate biological data relating to the user's respiratory behaviour that includes data on the changes to the upper body circumference as a consequence of breathing, heartbeat, body temperature and skin resistance.

Furthermore, the ability to simultaneously acquire load and motion data in conjunction with the biological data measurements provides the means to discriminate between biological data affected by external load on the garment and position or motion of the garment, so said computer-implemented methods may be able to select and deselect multiple of the strain sensors to use the most reliable sensor data depending on load or motion and quality of the sensor's reading. This enables the system to output more reliable biological data relating to a user's respiratory behaviour, record and report the user’s breathing patterns, discover imminent episodes of specific types of respiratory problems, and may result in informing the user by means of a sensory alarm of such suspected episodes, thus assisting the user in preventing and overcoming such episodes.

In accordance with the characteristics of the present invention, there is provided a method to use measured data to determine the presence or imminence of episodes of respirational disorder, with the objective to provide an audible or sensory alarm to the user of such. The method may further comprise providing, by means of the display device and audio device, visual and audible clues and guidance of provided exercise programmes to help the user prevent and mitigate the consequences of an imminent or current episode of a respiratory issue.

In accordance with the characteristics of the present invention, there is also provided a method to store and analyse provided mformation of all consenting users of the invention on a computer system, with the objective of this data being fed to a pattern recognition module that is configured to detect patterns in acquired data that may predict the imminence of an episode of respiratory issues, and in response to suggest to the wearer a means or exercises to prevent such episodes, and means to transfer these algorithms to the user monitoring controller,

With these features, the nser’s monitoring controller's analyser logic is updated instantly with the most up-to-date insights in the pattern recognition for the user's specific respiratory problems.

BRIEF DESCRIPTION OF THE DRAWINGS

Various embodiments of the invention are disclosed in the following detailed description and accompanying drawings.

Fig. | depicts a functional block diagram of an example implementation of the disclosed

IS system and its components that together compose the “biological information measurement equipment with multi-sensor monitoring device and respiratory problem alarms”,

Fig. 2 depicts a perspective view of an example embodiment of the disclosed wearable sensor garment and its cornponents,

Fig. 3 illustrates an example method flow representation of the functional working of the various components of the monitoring system in accordance with the invention,

Fig 4 depicts the composition and components of an example low hysteresis knitted-in strain sensor and its signal amplifier, in (a) an overview and (b) perspective detail view, as knitted into garment as an array of sensors, optionally attached to a signal amplifier on a zipper’s tape, closed over the front of the user’s upper body, and to a body encircling wire connected to the zipper’s other tape as body circumference measurement sensor and external load sensor,

Fig 5 illustrates the composition and components of an example knitted dry patch sensor in (a) a perspective view and (hb) a cross-sectional view, as used in ECG and conductivity sensors,

Fig 6 illustrates the composition and components of an example thermistor, attached to the garment in (a) a perspective view and (b} a cross-sectional view, as used as body temperature sensor,

Fig 7 depicts a block diagram of the functional components enclosed in an example monitoring controller, including inertial measurement unit, the wiring loom connector, the battery power supply and charging devices,

Fig 8a depicts an example monitoring controller and an example wiring loom connector used ta connect the wiring loom to the monitoring controller,

Fig 8b and Se illustrate an example configuration of the mounting gear to fix the monitoring controller to the garment and at the same lime connect it to the wiring loom in {b) a perspective view and {c} a cross-sectional view,

Fig 9 illustrates an example configuration of the SPO2 sensor attached to the monttoring controller and fixed to the user's index finger,

Fig 10 illostrates an example charging device and its connections to the monitoring controller,

Fig 11 depicts a block diagram representing a functional overview of a set of sensor inputs and the respective outputs in an example implementation of the system logic,

Fig 12 illustrates an example configuration of a hygienic inlay for complementing the disclosed garment, with holes at about the locations of the conductive patches as used for acquiring the electrical signals that represent the ECG signals and skin resistance, as a hygienic inlay to be worn under the wearable senor garment when used by multiple users as in a clinical setting.

Common reference numerals are used throughout the figures and the detailed description io indicate like elements. One skilled in the art will readily recognize that the above figures are examples and that other architectures, modes of operation, orders of operation, and elements/functions can be provided and implemented without departing from the characteristics and features of the invention, as set forth in the claims.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following is a detailed description of exemplary embodiments to illustrate the principles of the invention. The embodiments are provided to illustrate aspects of the invention, but the invention is not limited to any embodiment. The scope of the invention encompasses numerous alternatives, modifications and equivalent; it is limited only by the claims.

Numerous specific details are set forth in the following description in order to provide a thorough understanding of the invention. However, the invention may be practiced according to the claims without some or all of these specific details, For the purpose of clarity, technical material that is known in the technical fields related to the invention has not been described in detail so that the invention is not unnecessarily obscured.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be Hmiting of the invention.

As used herein, the term “and/or” includes any combinations of one or more of the associated listed tems.

As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms as well as the singular forms, unless the context clearly indicates otherwise.

It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof,

The terms "first", "second," and the like are used herein to describe various features or elements, but these features or elements should not be limited by these terms. These terms are only used to distinguish one feature or element from another feature or element, Thus, a first feature or element discussed below could be termed a second feature or element, and similarly, a second feature or element discussed below could be termed 3 first feature or element without departing from the teachings of the present disclosure,

The term “knitted-in” as used herein describes one alternative of the process of incorporating into knitwear materials that have physical characteristics that fundamentally differ from the knitting yams used, as a semi-automated process of placement of such materials inline with the weaving and fix them in place through interlocking, with the objective to make them flex with the knitwear. It should be understood that there are many alternative ways of implementing the process of knitting-in and that these methods evolve over time.

Embodiments of “biological information measurement equipment with multi-sensor monitoring device and respiratory problem alarms™ according to the present invention will now be described.

Fig, 1 is a diagram depicting an overview of each embodiment and its functional components, as explained in further detail in Fig. 2 to Fig. 12,

Specifically, Fig. 1 depicts a functional block diagram of an example implementation of the disclosed system and its components that together compose the “biological information measurement equipment with multi-sensor monitoring device and respiratory problem alarms”.

The system components include the wearable sensor garment 100 itself, which in the present example comprises a set of strain sensors 102, an SPO2 sensor 104, an ECG sensor 106, a set of skin resistance sensors 108, a body temperature sensor 110, a load sensor 112, and a monitoring controller 114. The monitoring controller itself has a number of integrated components, including a control processor 116, a BLE transmitter 118, a motion and positioning sensor 120, a power supply 122, a battery 124, and a battery charger 126.

.

The system components also include a portable user device 128 such as a mobile phone, computer, or even dedicated hardware device, which enables users to interface with the system,

The portable device comprises a user monitor 131 running the following modules: BLE listener module 130, analyser logic module 132, advisor logic module 134, data transfer module 136, presentation logic module 138, and which has a data storage 140. The portable device 128 also comprises a display 142, a sensory alarm 144, and an audible device 146.

Finally, the example system comprises a computer system 148 with high levels of data processing power, for example a cloud architecture of networked servers. The computer system comprises the following data processing function al modules 148: dats transfer module 150, 16 pattern recognition module 152, algorithm composer module 154, and a data store 156, It also comprises a module for exception reporting 158.

Referring to Fig. 2, a biological data gathering outfit 200 which is an embodiment of the wearable sensor garment comprises a tight fitting, elastic, non-conductive, washable textile 202, an array of low hysteresis kaitted-in strain sensors 204, vertically distributed evenly over the 1§ space from near the location of the user’s costal muscles to a location near the nser’s abdominal muscles, with the strain sensors knitted into the garment, attached to a body encircling semi- elastic wire 206 attached to the zipper’s tape 208 at opposite side of the body and closed by means of said zipper as to provide maximum freedom of movement while the user's puts the garment on or when removing the same, without risking the strain sensor maximum strain being exceeded, thus eliminating the risk of the sensors being overstretched. The ECG sensor array 210 consist of conductive, flexible, dry patches 212 attached to the inside of the garment al locations providing for best quality of registering high-resolution heartbeat signals. The skin conductivity patches 214 consist of conductive, flexible, dry patches attached to the inside of the garment at locations on the user's right shoulder blade, The thermometer 216 consists of a single thermistor circuit, attached to the inside of the garment, near the location of the armpit,

Isolated conductive leads, forming a wiring loom 218, feed the electrical signals of the above sensors into to the monitoring controller 220 by means of a moisture-resistant loom connector 222. The loom connector is also equipped with a terminal that is configured to receive the SPO2 sensor's 224 wire connector as to provide the SPO2 sensor's signal to the monitoring controller. The monitoring controller is equipped with a motion sensor delivering acceleration and rotation data. For hygienic purposes, the garment and its components are, with detached and stored monitoring controller, washable in water at 20°C (68°F) with a mild detergent.

Referring to Fig 3, the functional working of the example biological information measurement equipment with multi-sensor monitoring device and respiratory problem alarms, is explained.

At the time of putting on the wearable senor garment 300, the elastic garment aligns the sensors to near the required location on the user’s upper body. The user then attaches the monitoring controller to the wiring loom connector and fixes it by means of a strip of hook-and- loop fasteners. Through internal wiring in the loom connector, the monitoring controller starts and continuously acquires sensor readings from all attached and built-in sensors and transmit these readings by means of a wireless connection to the user’s portable device,

The user monitor software on the portable device 302 starts at the user's discretion. At the time the user monitor software starts, it obtains a bespoke, personalized algorithm from the

Computer System 304 by means of data communication, The user monitor software receives the sensor readings through a wireless connection and displays the functional meaning of the readings as explained in Fig 11 on the portable device's display, while it processes the readings

IS by means of said bespoke, personalized algorithm, that has the capability to detect signs that can help identily possible future episades of respiratory problems, When such an indication is detected, the user monitor software triggers an audible or sensory alarm that is delivered to the user by means of the capabilities of the portable device, displays the appropriate information on the portable device's display and suggests measures to the user to help prevent or mitigate the effects of said possible future episode of respiratory problems. The user monitor software stores the sensor readings in the portable device's storage and forwards it to the computer system at the time it detects the availability of a high-speed data communication connection. The user monitor software also has capabilities, made available io the user on request through a selection on a provided software menu, to record, store and forward personal information as required by the computer system.

The computer system 304 receives and stores meant sensor readings from all portable devices of all consenting users. The computer system has capabilities that analyse the sensor reading by means of software that has capabilities, commonly referred to as semi-supervised learning as part of the art of artificial intelligence, more specifically its discipline of pattern recognition, to detect patterns that are identified as indications of respiratory problems, and thus to composes and store bespoke algorithms. The computer system keeps track of changes to the essential rules and reports an exception when a change would impact the fundamentals of the workings of the algorithms, Through human inspection 306 of the exceptions, proposals for the adaption of the analyses and composition logics are prepared and, after approval by medical specialists, are implemented 11 the logic to Analyse Sensor Readings and the logic to Compose & Store Bespoke Algorithms.

Referring to Fig. da {top view, principle) and 4b (enlarged detail, perspective), more detail is provided on an example construction of the strain sensors 400.

S In the present example strain sensor 400 comprising one or more conductive cords and one or more non-conductive elastic yarn 403 knitted into the elastic fabric of the garment 202, is fixed to a zipper’s tape 402 at one side at the strain sensor mounting point, with the other side attached to the garment at the strain sensor wire side connection point 404 at approximately 100 millimetre distance, with the elastic yarn 403 forming a tunnel shape that helps the strain sensor 400 regain its original form and length when the strain is relaxed, thus reducing the polymers hysteresis. The strain sensor wire side connection point is attached to an electrically conductive sensor ground wire 406 knitted into the garment and connected to a ground connection of the strain sensor signal amplifier board 414, and a non-conductive semi-elastc body-encircling wire 408 looped over the back of the garment and fixed on the opposite side of the zipper at approximately the same height. The zipper 410 allows the user to open the garment during dressing without risking an overload of strain on the strain sensors, thus eliminating the risk of the sensors being overstretched during dressing. Sensor power and signal wires 412 are connected to the strain sensor signal amplifier board 414 at the location of the strain sensor mounting point at the zipper tape, with the signal amplifier mounted as close as possible to the knitted-in strain sensor as to provide a sensor signal of adequate characteristics, thus improving the sensor’s sensitivity and resolution, This arrangement is used to create an array of eight or more body encompassing loops. each composed of a strain sensor, body encompassing wire, mounting points, signal amplifier and their power and signal wiring, With this array a change in electrical resistance of the strain sensor as a consequence of a change in the user's body circunterence at the approximate location the sensor is positioned on is reflected as a change in electrical output signal of the strain sensor signal amplifier 414, Other configurations are also possible for achieving this.

In this example, the strain sensor signal amplifier board 414 comprises a semi-flexible printed circuit board 416 as depicted in Fig. 4b, attached to the zipper tape 492, equipped with the necessary electronics and connections 418 casted in a droplet of insulating material. The electronics are connected to the strain sensor 400, sensor ground wire 406 and sensor power and signal wires 412 as to complete the circuits that are grouped into the wiring loom 218 to be fed to the monitoring controller 220. Other configurations and constructions are also possible for achigving the amplification and signal transfer withont changing the workings of the strain sensor amplifier.

Referring to Fig. Sa (overview) and 8b {cross section), the composition of an example conductive patch 500 for mounting ECG and other conductivity-based sensors is explained. 3 A conductive patch comprises a knitted dry sensor patch 302 and connections of such, grouped to the wiring loom and connected to the control processor by the loom connector. The knitted dry sensor patch is composed of a tightly knitted thermoplastic yarn, with a knitted-~in pattern 504 of conductive yarn for which and example pattern is shown, knitted to the inside of the garment 506 over a pad of springy cushioning material 508, as such to provide some subtle 10 pressure to the conductive area where it meets the user's skin. During fabrication, the thermoplastic is heated to the point where it vulcanizes and thus forms a flexible, moisture proof layer, which is resistant to cleaning with sterilisation fhuds. These arrangements provide for means to pick up ECG signals and for measuring skin conductivity. Other configurations and signal wire mesh patterns are also possible for achieving this.

Referring to Fig, 6, more detail 1s provided on the construction of the body temperature sensor 600.

Fig. 6a and 6b illustrate an example form of the body temperature sensor encasing 602, comprising a thermistor 604, glued into a flexible heat conducting metal film pouch by means of a thermal conductive glue 606, sewn onto the garments fabric 608 close to the garments armpit 209 tape 610. The heat conducting metal film and thermal conductive glue transfer the armpil temperature to the thermistor that changes its output voltage in relation to the temperature transferred to its housing, The thermistor is connected to the monitoring controller by means of isolated conductive sensor signal wires 612, grouped into the wiring loom and connected to the monitoring controller by the loom connector. This arrangement provide for means for measuring changes in body temperature.

Referring to Fig. 7, the components that make up the monitoring controller 700 are explained. The components are powered by a rechargeable battery 702 through a power supply circuit 704. A battery charge controller circuit 706 is fed by a wireless battery charger 708 or an external battery charger connected through the wiring loom connector 710 and charges the battery when connected. Through internal wiring in the loom connectors, the battery power is only fed to the control processor and BLE Radio transmitter 712 when the wiring loom is connected, In this example implementation, the wearable garment can only operate when the battery charger is disconnected from an external power source. Signals from all sensors and the built-in motion and positioning sensor 714 are fed to the control processor 716. The control processor acquires, processes and transmits the sensor readings as instrated in Fig. 3. The control processor uses patterns of flashes of the nulti-colcur LED 718 to indicate statuses that may need the user’s attention,

Referring to Fig. &a, an example construction of the monitoring controller 800 and its connectors is illustrated. The monitoring controller comprises a sealed, motsture-proof housing 802 that contains its functional components, including mertial measurement unit, the female wiring loom connector 804, the battery power supply, the multi-colour indicator LED, charging device, and all of its connections as depicted in Fig. 7.

The wiring loom connector 806 comprises a sealed, waterproof encasing encompassing the 18 waterproof male wiring loom commector 808, the waterproof female SPO2 sensor connector terminal, and the wiring loom’s end. Depending on the state of art and its development, and changes in arrangement and number of connected sensors, alternative forms, size and shapes for the construction of the monitoring controller, its connectors and encasing are foreseen, without changing the workings of the monitoring controller.

Referring to Fig. 8b and 8c, the example configuration shown in Fig.8a is now shown with the monitoring controller 800 connected to the wiring loom connector 808, in this exaniple, the wiring loom connector is fixed to the garment 810 by means of a semi~ flexible fixing plate 812, to which it is secured by means of two or more fixing screws 814 applied through the garment’s fabric at the time of assembly. The monitoring controller 800 is connected to the wiring loom connector 808 by means of a 50-contact gold-plated multi-pin PCB edge connector. The monitoring controller 800 is fixed to the fabric of the garment by means of a strip of hook-and-loop fasteners 816. The monitoring controller can thus be detached from the garment by detaching it from the strip of hook-and-loop fastener, and then disconnecting it from the wiring loom connector, for service, maintenance, and charging. When connected, the monitoring controller is powered on by internal wiring of the loom connector, tapping power from the internal rechargeable battery, as indicated by a lit monitoring controller indicator on the shell of the monitoring controller that changes colour when a connection with the user moniter has been established.

Referring to Fig, 9, the monitoring controller 900, attached to the wiring loom connector 36 902 and with connected, medical grade external SPO2 sensor 904 are illustrated being used by a user 906, The SPO2 sensor wire 908 is connected to the SPO2 sensor loom connector 910 at the time the user wishes to deploy the SPO2 sensing fingertip clip. The loom connector 910 feeds the SPO2 sensing fingertip clip’s 904 reading to the monitoring controller 900 that includes these readings in the data exchanged with the user monitor.

Referring to Fig. 10, the setup for charging the monitoring controller 1000 is illustrated.

When detached from the wiring loom connector, the monitoring controller can be connected to a charging device (not shown), comprising a suitable SV power supply 1002 or powered USB port and a charge connector 1004, consisting of a female connector with 2 gold plated leads at one 53 end and a suitable connector at the opposite. At the time the monttoring controller is being charged, as indicated by a flashing monitoring controller indicator 1006 on the shell of the monitoring controller, there cannot be any connection with components on either the garment, thus making it impossible to establish electrical contact with the user through the monitoring controller whilst being connected to mains or ground, Once charging is complete, the monitoring coniroller indicator 1006 will change from flashing to a constant indication.

Referring to Fig. 11, a block diagram representing a functional overview of 4 set of sensor inputs and the respective outputs in an example implementation of the system logic that make up the functional working of the present invention is illustrated.

The signals from the sensors, which include: strain sensor input 1102, conductor sensor input 1104, armpit thermometer input 1106, ECG patch mput 1108, load sensor input 1110, inertial measurement unit input 1112, and SPO2 sensor input 1114, are read by the control processor in the monitoring controller and transmitted by means of its BLE transmitter. The analyser logic 1116 in the user monitor receives said signals by means of its BLE listener, and interprets the respective signals to produce corresponding biological information outpuis that represent changes and patterns in: breathing 1118, skin resistance as a measure for perspiration 1120, skin temperature as an expression of body temperature 1122, heartbeat 1124, external load on the array of sensors 1126, motion and attitude of the user 1128 and blood oxygen saturation level 1130.

The information is collected in the data store and transmitted to the computer sysiem by means of the data transfer function when a high-speed connection is available, with the objective to collect meant information for use by the computer system’s bespoke algorithms composition logic as illustrated in Fig. 3. The measured information is interpreted by the analyser logic to detect breathing patterns, and ia detect changes in the user's level of comfort, as expressed by changes in heartbeat, specific artifacts in the heartbeat signals, perspiration, and body temperature, Sensor readings and detections are made visible on request on the portable device's display device in various forms, amongst which are accurate graphical representations of the sensor data, numeric and graphical representations of the information contained therein, and in some examples a graphical three-dimensional model of the kuman upper body mimicking the recorded breathing and its detected artifacts,

The information contained in the sensor data is interpreted by the analyser logic 1116 with the objective to determine the need to issue alarms and suggestions for counter measures, as to prevent and mitigate the consequences of an episode of respiratory problems. In case an alarm needs to be raised, the nser is informed by means of a sensory signal by means of the haptic feedback system of the portable device, and optionally by means of an audible signal.

Referring to Fig 12, a hygienic inlay 1200 for use of the sensor garment by multiple users is depicted. For the purpose of allowing use of the garment by mulliple users in clinical environments, a lightweight flexible garment is applied to the user's upper body with holes 1202 close to the locations of the knitted dry patch sensors, as explained in Fig, 8. During clinical use, the hygienic inlay allows the garment’s dry patch sensors, after cleaning using a sterilisation solution, to make contact with the user's skin, thus bringing only necessary areas of skin in contact with the garment, reducing the risk of undesired transfer of biological materials, The hygienic inlay is fabricated to such standards that it is washable at high temperatures or can be disposed of after single vse,

The methods and operations disclosed herein may be implemented by any suitable computer architecture.

A computer may be a uniprocessor or multiprocessor machine, Accordingly, a computer may include one or more processors and, thus, the aforementioned computer system may also include one or more processors. Examples of processors include sequential state machines, microprocessors, microcontrollers, graphics processing units (GPUS), central processing units {CPUs), application processors, digital signal processors (DSPs), reduced instruction set computing (RISC) processors, systems on a chip (SoC), baseband processors, field programmable gate arrays (FPGAS), programmable logic devices (PLDs), gated logic, programmable control boards (PCBs), and other suitable hardware configured to perform the various functionality described throughout this disclosure.

Additionally, the computer may include one or more memories. Accordingly, the aforementioned computer systems may include one or more memories, A memory may include a memory storage device or an addressable storage medium which may include, by way of example, random access memory (RAM), static random access memory (SRAM), dynamic random access memory (DRAM), electronically erasable programmable read-only memory (EEPROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), hard disks, floppy disks, laser disk players, digital video disks, compact disks, video tapes, audio tapes, magnetic recording tracks, magnetic tunnel junction (MT) memory, optical memory storage, quantum mechanical storage, electronic networks, and/or other devices or technologies used to store electronic content such as programs and data. In particular, the one or more memories may store computer executable instructions that, when executed by the one or more processors, cause the one or more processors to implement the procedures and techniques described herein. The one or more processors may be operably associated with the one or more memories so that the computer execntable instructions can be provided to the one or more processors for execution. For example, the one or more processors may be operably associated to the one or more memories through one or more buses, Furthermore, the computer may possess or may be operably associated with input devices {e.g., a keyboard, a keypad, controller, a mouse, a microphone, a touch screen, a sensor) and output devices such as (e.p. a computer screen, printer, or a speaker).

The computer may advantageously be equipped with a network communication device such as a network interface card, a modem, or other network connection device suitable for connecting to one or more networks.

A computer may advantageously contain control logic, or program logic, or other substrate

IS configuration representing data and instructions, which cause the computer to operate in a specific and predefined manner as, deseribed herein. In particular, the computer programs, when executed, enable a control processor to perform and/or cause the performance of features of the present disclosure. The control logic may advantageously be implemented as one or more modules, The modules may advantageously be configured to reside on the computer memory 29 and execute on the one or more processors. The modules include, but are not limited to, software or hardware components that perform certain tasks. Thus, a module may include, by way of example, components, such ag, software components, processes, functions, subroutines, procedures, attributes, class components, task components, object-oriented software components, segments of program code, drivers, firnyware, micro code, circuitry, data, and/or the like.

The control logic conventionally includes the manipulation of digital bits by the processor and the maintenance of these bits within memory storage devices resident in one or more of the memory storage devices. Such memory storage devices may impose a physical organization upon the collection of stored data bits, which are generally stored by specific electrical or magnetic storage cells,

The control logic generally performs a sequence of computer-executed steps. These steps generally require manipulations of physical quantities. Usually, although not necessarily, these quantities take the form of electrical, magnetic, or optical signals capable of being stored, transferred, combined, compared, or otherwise manipulated. It is conventional for those skilled in the art to refer to these signals as bits, values, elements, symbols, characters, text, terms,

numbers, files, or the like. It should be kept in mind, however, that these and some other terms should be associated with appropriate physical quantities for conputer operations, and that these terms are merely conventional labels applied to physical quantities that exist within and during operation of the computer based on designed relationships between these physical quantities and the symbolic values they represent. it should be understood that manipulations within the computer are often referred to in terms of adding, comparing, moving, searching, or the like, which are often associated with manual operations performed by a human operator. It is to be understood that no involvement of the human operator may be necessary, or even desirable. The operations described herein are machine operations performed in conjunction with the human operator or user that interacts with the computer or computers.

It should also be understood that the programs, modules, processes, methods, and the like, described herein are but an exemplary implementation and are not related, or limited, to any particular computer, apparatus, or computer language. Rather, various types of general-purpose computing machines or devices may be used with programs constructed in accordance with some of the teachings described herein. In some embodiments, very specific computing machines, with specific functionality, ray be required.

Unless otherwise defined, all terms (including technical terms) used herein have the same meaning as commonly understood by one having ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and the present disclosure and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The disclosed embodiments are illustrative, not restrictive. While specific configurations of the garment, system, and method have been described in a specific manner referring to the illustrated embodiments, it is understood that the present invention can be applied to a wide variety of solutions which fit within the scope and spirit of the claims, There are many alternative ways of implementing the invention,

It is to be understood that the embodiments of the invention herein described are merely illustrative of the application of the principles of the invention. Reference herein to details of the illustrated embodiments is not intended to limit the scope of the claims, which themselves recite those features regarded as essential to the invention,

Claims (19)

CONCLUSIONS 1. An assistive device comprising a garment intended to encase the upper body of its wearer, the garment being made of elastic material, and the garment being equipped with: one or more sensors configured to measure biological data of the wearer, including at least data indicative of changes in the body circumference of the user during breathing, said sensors being positioned at one or more locations on the garment and generating a first set of electrical signals corresponding to said biological data; one or more additional sensors configured to measure at least a second type of sensor data, including at least data indicative of the body movements of the wearer and the external load on the garment, said additional sensors generating a second set of electrical signals; one or more electronic measuring and control units coupled to the one or more sensors and the one or more additional sensors, said controllers being configured to receive and process the first and second sets of electrical signals; data transmission equipment. coupled to the one or more controllers to transmit the processed signals to an external computing device for further analysis, the analysis comprising distinguishing valid and invalid measurements of the first set of data based on the second set of data with respect to the wearer's movements and external loading; wherein the elastic material and configuration of the garment facilitate consistent placement of the sensors at specific points on the wearer's body for reliable data recording. 2. The device of claim 1, wherein a sensor comprises an array of eight or more strain sensors distributed across the upper body from at least below the location of the abdominal muscles to above the location of the pectoral muscles of the user, the electrical characteristics of the strain sensors changing in response to changes in the circumference of the upper body during breathing, 3. The device of claim 1, wherein the one or more sensors include a first array of conductive contact points disposed on the interior of the garment at locations optimal for capturing an electrocardiogram (ECG) signal. 4. The device of claim 1 further comprises one or more strain sensors designed to measure and record the forces exerted by the user's body movements and external loads on the array of strain sensors of claim 2. 5. The device of claim 1, wherein the one or more sensors include a second set of conductive contact points positioned on the inside of the garment so as to be aligned with the underside of the user's right thigh, the contact points constituting sensors for measuring skin resistance. &. The device of claim 1 further includes a thermometer located near the wearer's right armpit, the electrical properties of the thermometer changing in response to changes in the wearer's body temperature. 7. The device of claim 1, further comprising an inertial measurement unit configured to provide data representing orientation and movements, and capable of capturing user input resulting from physical interaction with the housing. 8. The device of claim 1 further includes a sensor designed to measure peripheral capillary oxygen saturation, the sensor being either a clip attachable to a finger or placed at a suitable location on the user's body. 9. A system for monitoring biological data relating to the respiratory behaviour and related vital signs of a user, comprising: a wearable garment configured to be worn over the torso of a user and containing a plurality of sensors including at least strain sensors, motion sensors and conductivity sensors; one or more electronic measuring and control units connected to the sensors, the measuring and control units receiving and processing electrical signals generated by the sensors indicative of one or more changes in upper body circumference, heart rate, body temperature and skin resistance; a wearable computing device with software for storing, interpreting and presenting the signals processed by the one or more measuring and control units; one or more alarm devices capable of generating audible and sensory alarms based on analysis of the interpreted signals; and one or more processors coupled to the wearable computing device and configured to perform computer-implemented methods to analyze the sensor data, identify patterns predictive of impending respiratory attacks, and provide training suggestions to prevent or mitigate such attacks; and wherein the system is further configured to distinguish between biological data affected by external loading and position or movement of the garment, thereby improving the reliability of the biological data. 10. The system of claim 9, wherein the one or more alarm mechanisms are configured to generate both audible and sensory alarms, 11. The system of claim 9, wherein the software in the portable computing device is configured to connect the user monitor to the one or more measurement and control units and to a computer system including one or more processors and storage devices. 12. The system of claim 9, wherein the system further comprises a sanitary insert adapted to be worn under the garment, having holes positioned to align with the positions of the conductive contact points of the garment. 13. A computer-implemented method for interpreting sensor data collected by a wearable sensor garment to monitor and analyze a user's respiratory data, comprising: receiving sensor data from a wearable garment configured to measure changes in one or more of: upper body circumference, heart rate, body temperature, perspiration, and peripheral capillary oxygen saturation of a user, transmitting the data to a monitoring controller; storing the received sensor data in a data storage device; analyzing the stored sensor data to determine patterns indicative of impending respiratory distress, the analysis of the stored sensor data distinguishing between data affected by external loading of the garment and position or movement of the garment; and generating an alarm signal upon detecting the patterns, the alarm signal being transmitted to one or more alarm devices capable of producing audible and sensory alarms. i4. The computer-implemented method of claim 13 further comprises providing training suggestions to the user via a wearable computing device based on the analyzed data, the suggestions aimed at preventing or reducing identified respiratory problems. 15. The computer-implemented method of claim 13 further comprises connecting the monitoring controller to a network server or processing device configured to execute logic that stores and analyzes biological data from multiple connected users, 16 The computer-implemented method of claim 13, wherein the generated warning signal is customized based on the specific type of impending respiratory problem detected. 17. The computer-implemented method of claim 13, further comprising collecting user input via an inertial measurement unit in the wearable garment, the user input being used to signal the control processor of a significant event related to the monitored respiratory problem. 18. The computer-implemented method of claim 15, wherein the alert signal is transmitted to a secondary device such as a health care provider's computer system. 19. The computer-implemented method of claim 13 further comprises feeding the stored and analyzed data to a pattern recognition module configured to improve detection algorithms for predicting impending respiratory problems,