FIELD OF THE INVENTION

[0001] The present invention relates to systems and methods to improve the reliability, reproducibility and applicability of spirosonometric measurements of human pulmonary function.

BACKGROUND OF THE INVENTION

[0002] Any discussion of the background art throughout the specification should in no way be considered as an admission that such art is widely known or forms part of common general knowledge in the field.

[0003] Spirometry is an established and validated method of measuring the flow of air through the mouth to reflect the gross performance of the respiratory system. The velocity, volume and pressure of the respiratory flow is identified and can be graphed for clinical analysis and diagnosis.

[0004] Abnormalities in these velocity, volume and pressure values and plots change with normal physiology, such as exercise, and in diseases and with therapy. Diseases such as asthma, chronic obstructive pulmonary disease (COPD), occupational lung disease (OLD), and more recently COVID in both the acute and chronic stages. In excess of 500m people have chronic respiratory disease globally and the incidence is increasing with deteriorating air quality, occupational hazards and behavioural inhalations. Three of the world’s top 10 causes of death are related to respiratory disease.

[0005] Although spirometry is clinically well accepted, its widespread adoption is limited by poor device methods, poor patient compliance, limitation of suitable device disinfection, and limited patient access. A significant cause of poor compliance is the reliability and maintenance of the devices, and the difficulty of performing the required manoeuvres to create a reliable diagnostic signal.

[0006] Spirometry can be used on all ages, but it depends for its effectiveness on completion of an appropriate examination, and this requires clear instruction, and effective performance of the examination by the user. However not all patients are adequately responsive, and particularly in young children, and the aurally and visually impaired, effective instruction and guidance for the performance of spirometry is often ineffective. [0007] The effectiveness of spirometry depends on the reliability of single measures, and the commitment of patients to complete repeated examinations, often daily, for appropriate diagnosis and serial management.

[0008] The lungs are two organs, situated in the left and right of thorax around the heart. Combined with the heart, the lungs are vital components of the respiratory system, providing vital oxygen to the cells of the body to ensure their survival. The lungs function to inhale ambient air by expanding the thoracic cavity, which draws air into the lungs. Oxygen is then extracted from the inhaled gas and passes across the walls of the pulmonary veins into the blood stream, and then delivered by the rhythmic contraction of the heart and vessels to the cells of the body. Once the oxygen is extracted from the air in the lungs, the thorax is actively contracted and the deoxygenated air containing some excretory wastes are exhaled. The normal lung is an elastic reservoir which expands and contracts during breathing with a baseline volumetric capacity. The volume of the air inhaled and exhaled is directly proportional to the oxygen delivered into the vascular system for transport to the cells and can be increased on demand such as during exercise and during sickness.

[0009] Various pathologies interfere with both the elasticity of the lungs and the absorption of oxygen in the lungs, thus reducing the capacity of the circulation to supply oxygen to the cells of the body. Chronic and acute impairment of lung function results in hypoxia, expressed as shortness of breath, which results in impaired cellular function, and ultimately death of sensitive oxygen dependent organs. Conditions including asthma, chronic obstructive pulmonary disease (COPD), occupation lung disease and post pulmonary infections such as COVID, pneumonia and bronchitis, which can all result in seriously impaired lung function and potentially increased mortality.

[0010] Spirometry is an accepted, accurate and cost-effective method for quantitative evaluation of lung function. The spirometry device simply measures the flow of air into and out of the mouth with the nose closed, allowing accurate calculation of the total respiratory volume, velocity and pressures. While the method is simple and the information acquired is vital, its widespread adoption is restricted by technical and practical limitations which are often related to poor user training and motivation. This is particularly so in children, where asthma is common, and the detection and grading of the disease, and appropriate choice and effectiveness of therapies and therapeutic response is most critical.

[001 1] Spirometers can be categorised into 3 groups depending on the method of measuring the respiratory flow. These include: Turbine, Thermal gradient and Ultrasound transit time [0012] Both turbine and thermal gradient devices have significant technical limitations which reduce their accuracy. They both require elements to be placed in the field of flow, obstructing the flow, and reducing the accuracy of measurements particularly in reduced flow conditions found in common respiratory diseases. As they are both effectively mechanical devices, they require frequent calibration to ensure accuracy of measurements. These resistive elements also provide traps for respiratory residue and infection, and make disinfection more difficult.

[0013] The spirosonometer utilises transit time ultrasound across a single, smooth and parallel walled, unobstructed flow-tube, which ensures linear flow for enhanced accuracy, and facilitates simple disinfection. Additionally the flow is unobstructed, and so even in small children and in low flow conditions the measurements are accurate and make the examination easier for the patient. As the measurement method is ultrasonic the measurements are calibrated to the speed of sound, a constant, and so the devices are very stable and require minimal calibration. This physically advanced form results in reliable and accurate measurements. Turbine and thermal gradient devices where baseline signals vary significantly use to use and require frequent calibration provide variable and unreliable input. One such design of a spirometry system can be that as described in US Patent Publication 20100095782 entitled “METHOD AND APPARATUS FOR DETERMINING THE FLOW PARAMETERS OF A STREAMING MEDUM”, the contents of which are incorporated by cross reference.

[0014] The following parameters are calculated by the spirosonometer:

[0015] Spirometry parameter abbreviations stand for: VC - Vital Capacity, FVC - Forced Vital Capacity, FEV1 - Forced Expiratory Volume in 1st second, FEV6 - Forced Expiratory Volume in 6th second, FVC - forced expiratory vital capacity, IVC - inspiratory vital capacity, EVC - expiratory vital capacity / SVC - slow vital capacity; FIVC - forced inspiratory vital capacity; FIV1 - forced inspiratory vital capacity in 1st second; EV = EVC; PEF - Peak Expiratory Flow, PIF - Peak Inspiratory Flow; FEF25 - the average flow from the point at which 25 percent of the FVC has been exhaled; FEF50 - the average flow from the point at which 50 percent of the FVC has been exhaled; FEF75 - the average flow from the point at which 75 percent of the FVC has been exhaled; FIF25 - the average flow from the point at which 25 percent of the IVC has been inhaled; FIF50 - the average flow from the point at which 50 percent of the IVC has been inhaled; FIF75 - the average flow from the point at which 75 percent of the IVC has been inhaled; MMEF2550 - Maximum expiratory flow in the 2nd quarter of the exhalatory cycle; MMEF2575 - Maximum expiratory flow in the mid-section of the exhalatory cycle; FET - Forced Expiratory Time; IC - Inspiratory Capacity; ERV - Expiratory Reserve Volume; TV -Tidal Volume; TI - Tidal Inspiration; TE - Tidal Expiration; RR - Respiratory Rate; MW - Maximum Voluntary Expiration.

[0016] Pulmonary evaluation equipment allows the measurement of multiple aspects of pulmonary function. Such measurements can be helpful for: Defining normal lung function during routine physical examinations; Detecting, diagnosing and grading the severity of abnormal lung function; Selection of appropriate therapies and evaluating the response and effectiveness of these therapies.

[0017] For effectiveness lung function testing requires baseline monitoring and is usually accompanied by maximal inhalation and exhalation to establish pulmonary reserve, or the capability of the lungs to perform at extremes of function when respiratory volumes are required to increase to match increased oxygen demand. Depending on which characteristic of pulmonary function is being measured, a subject may need to exert maximal effort to provide the necessary results, while certain manoeuvres may be required to be performed during monitoring. These physical manoeuvres can be complex to explain and difficult to encourage subjects to perform. This may be achieved by performing the spirometry examination in a hospital, doctor's office, or laboratory where experienced technicians are available to provide continuous instructions and encouragement to the subject throughout the test. Much of the benefit of spirometry depends on its accurate repeat utilisation accompanied by expert diagnosis.

[0018] However, this application model is particularly challenged when: 1. The pulmonary evaluation equipment is used remotely and without supervision by atrained technician: Subjects may be unable to complete a test optimally and may be unsure if the performed test is adequate or inadequate. 2. The quality of tests may vary in the same pulmonary clinic due to differences in test technician coaching skills. The same patient tested by different technician in follow-up visits may have inconsistent test results due to variations in coaching techniques. 3. Some pulmonary evaluation equipment includes a video monitor that can provide visual encouragement. However, such visual feedback is either not universally implemented nor universally adopted resulting in varying formats creating varying patient incentives and ultimately varying results. Additionally, visual feedbacks may not be adopted at all. 4. Verbal guidance alone may improve spirometry operations in adults. However, in children such instructions, particularly in the very young, are much less successful. [0019] A further enhancement of the spirosonometric clinical care model is the training of patients to conduct accurate and repeatable self examination with the transmission of results via phone and web based media to central clinics where expert diagnosticians can provide immediate and expert diagnosis and recommend optimal therapy. However, the delivery of this telehealth model depends on the performance of high quality spirometry by the patient in the home. The use of on board, voice guided examination instructions standardises user training and performance feedback remotely and personally, making the tests more reliable and less variable. This spirosonometric model potentially provides the highest level of cost-effectiveness for the patient, the hospital and health care system as any methods and techniques that can improve the reliability and repeatability of spirometry will enhance its adoption and effectiveness.

[0020] Various audio-visual feedback mechanisms have been devised to improve the effectiveness of spirometry by reducing the required levels of supervision and operator instruction, and delivering higher quality clinical reports.

[0021] Current spirometry outputs, such as those illustrated in Fig. 1, are simple X Y graphical outputs, with the X axis representing volume and the Y axis flow. This provides an accurate but difficult to interpret visual display in the hands of experts and is difficult to understand for nonclinicians and certainly for children.

SUMMARY OF THE INVENTION

[0022] It is an object of the invention, in its preferred form to provide an enhanced form of spirosonometry measurement

[0023] In accordance with a first aspect of the present invention, there is provided a method of providing audible or visual signals related to measurement of pulmonary function, to the user undertaking the measurement, the method including the steps of: (a) receiving a pulmonary input signal from a pulmonary measurement device, with the pulmonary input signal measuring the pulmonary activities of the user; and (b) generating an audible or visual feedback signal for an output speaker or display accessible by the user, with the audible or visual signal being responsive to the pulmonary input signal.

[0024] In some embodiments the pulmonary input signal measures the exhalation of the user.

[0025] In some embodiments, the feedback signal comprises a verbally responsive audio signal and a color coded visual signal. In some embodiments, the generating step (b) further includes: determining one or more pulmonary characteristics of the pulmonary input signal and generating the audible or visual signal based on the one or more pulmonary characteristics.

[0026] In some embodiments, the one or more pulmonary characteristics include the flow rate of the pulmonary input.

[0027] In some embodiments, the generating step (b) includes: determining a first input level using the input pulmonary signal at a first point in time; determining a second input level using the input pulmonary signal at a second point in time; and generating the responsive audible signal through the speaker and a visual signal on the monitor based on the difference between the first input level and the second input level.

[0028] In some embodiments, the feedback audible signal comprises a motivational responsive audible signal and the feedback visual signal comprises a motivational color coded animation.

[0029] In some embodiments, the step (b) includes: generating an audible instruction signal through the speaker and a visual instruction graph on the monitor.

[0030] In some embodiments, the method further includes receiving a pulmonary test type selection; and generating an audible instruction signal through the speaker and a visual graph on the monitor based on the pulmonary test type selection.

[0031] In accordance with another aspect of the present invention, there is provided a method of providing an audible or visual feedback while measuring the pulmonary function of a user, the method comprising: accepting an input from a pulmonary measurement system attached to the user; analyzing the input, to measure a value of the input; and generating, using the device, an audible or a visual feedback to the person in response to the value of the input.

[0032] In some embodiments, the analyzing the input to measure the value of the input comprises : analyzing the input within the device to measure the value of the input two or more times in succession. In some embodiments, the generating the audible and the visual feedback to the person in response to the value of the input includes: generating the audible and a visual feedback to the person in response to each of the measured values of the input.

[0033] In some embodiments, the input comprises a measure of the user’s inhalation and the method includes generating an audible and a visual instruction to the person. The generating an audible and a visual instruction to the person can include receiving a pulmonary test selection from the person; and selecting the audible and the visual instruction based on the pulmonary test selection.

[0034] In some embodiments, the method includes: receiving identifying information from the person; and selecting the audible and the visual instruction based on the pulmonary test selection and the identifying information. The identifying information can be selected from a group consisting of an age and a health condition.

[0035] The step of generating, using the device, the audible and visual feedback to the person can include: receiving a pulmonary test selection from the person; and generating, using the device, an audible and a visual feedback instruction to the person based on the pulmonary test selection and the value of the input. The audio sequence can contain a single sine wave, of which the frequency is modulated by the input signal. The frequency can increases / decreases with the increase of the amplitude of the input signal (flow or volume). In some embodiments, the used frequencies of the sine wave are quantized. The selected frequencies are music tones, can include C (264 Hz), D (297 Hz), E (330 Hz), F (352 Hz), G (39 Hz), A (440 Hz), H (495 Hz), C (528 Hz), D (59 Hz), E (660 Hz), F (704 Hz), G (792), A (880 Hz). Preferably, unwanted noise, which was introduced by the change of frequencies, is eliminated. Preferably, the two neighbouring sine-waves with different frequency are fit together: the second wave starts (phase is 0 degree) only when the first wave finishes (phase is 360 degrees). In some embodiments, the audio sequence contains a single square wave, whose frequency is modulated by the input signal.

[0036] In some embodiments, the video signal (animation) is respiratory -driven in real-time; each frame of the video sequence is drawn as response of the actual and previous samples of the respiratory flow/volume; each video sequence is unique to the actual pulmonary manoeuvre and it changes from manoeuvre to manoeuvre. In some embodiments, the sound signal can be respiratory -driven in realtime; each output sample of the audio sequence is generated as response of the actual and previous samples of the respiratory flow/volume; each sound sequence is unique to the actual pulmonary manoeuvre and it changes from manoeuvre to manoeuvre. Both the video signal (the animation) and the sound signal can be truly respiratory -driven real-time generated sequences. Beside the respiratory flow / volume samples the video and or the audio can be also determined by one or more patient data, visit data, pseudo-random data, periodically changing variable or sequence of variables, therefore the generated video and or audio sequence has even more variability.

[0037] The video and or the audio sequence can be used as an incentive in spirometry, especially in paediatric spirometry. The audio-visual sequence, the incentive, accompanying the paediatric or adult spirometry can be a computer game (gamified spirometry) with carefully chosen scoring, where the score is displayed in a visible manner and the main function of the scores is the motivating the patient performing better and better via accessing higher and higher scores. The game can be a jump over a gap with a car; with the score is the length of a flight;

[0038] In some embodiments, the audio-visual feedback (the sequence) has more than one level, with one level designed to give feedback on the performance (progress-incentive) and another level implemented to entertain the user while still driven by actual and previous respiratory signals. Both levels can be traced in real-time. The progress incentive can visualize the actual performance compared to the predicted (reference) performance and be quantified. The stages can be logarithmic, in one embodiment there are 10 stages and the stages are as follows: 0 - 0%, 1 - 30%, 2 - 48%, 3 - 61%, 4 - 70%, 75 - 8%, 6 - 85%, 7 - 92%, 8 - 96% and 9 - 100%, where the first number is the number of the stage, while the second number is the lower threshold of the performance in percentage for that stage.

[0039] In some embodiments, the video sequence of the progress incentive has preferably 10 stages: 9 small faces in a horizontal line on top the main incentive; progress of the stages result more faces to be visible, faces turning from sad to happy, color of face turning from red to yellow then to green as the performance escalates. The audio sequence can be a progress incentive which has preferably 10 stages: 10 music tones or frequencies in increasing or decreasing order. The audio - sequence can be implemented so that it provides feedback on the progress for visually impaired patients.

[0040] In accordance with a further aspect of the present invention, there is provided a system for measuring pulmonary function, comprising: a receiver, configured to accept an input from a pulmonary system of a person; an input carrier, connected to the receiver and configured to carry the input from the receiver to a sensor, the sensor configured to measure a value of the input; a processor connected to the sensor, wherein the processor is configured to select an audible and a visual signal in response to the value of the input; and a speaker connected to the processor, wherein the speaker is configured to generate audible feedback based on the audible signal; and a monitor connected to the processor, wherein the monitor is configured to visualize a graphical feedback based on the input signal. The system can be contained in a handheld device.

[0041] The effective performance of spirometry can be improved by the adoption of user guided protocols with appropriate on board analysis and user feedback. Both single measure and serial monitoring is improved by a form of audio-visual feedback. [0042] For example, clinical trainers and even games can been used as motivation, particularly for children, to effectively complete the examinations. Additionally, subjects with impaired sight or hearing may be challenged to complete adequate examinations.

[0043] As outlined below, a number of audio-visual feedback methods are incorporated into current examination protocols and devices to simplify and improve the application of spirometry. These audio-visual incentives and feedbacks have particular application in children and the visually and aurally impaired, as well as those requiring on going motivation for long term serial monitoring of chronic respiratory diseases such as asthma, COPD and post COVID syndrome.

[0044] The objective analysis of lung function, performance prediction and various physiologic modelling can also be enhanced integration of on board Al.

[0045] The current invention describes enhanced spirosonometry, based on superior transit time ultrasonic technology enhanced with audio-visual motivational software, on board user instruction including interactive user feedback and auto-diagnostic software to generate enhanced compliance to optimise use and results of spirometry. Enhanced Spirosonometry is conceived to improve compliance and clinical outcomes in patients with lung disease.

[0046] Whilst the invention can be implemented in many different forms, a number of forms of current implementation will be described in a below embodiment, referred to as the SpiroSonic system.

[0047] The SpiroSonic system can be implemented in a variety of hardware and software configurations. In one embodiment, hardware is a compact sensor device with a USB communication to a computer and all audio-visual methods and solutions are implemented in a PC software (SpiroReporter).

[0048] In another embodiment, the hardware is a compact handheld device without any wired interface. The device is charged by means of wireless charging and the communication to a software on a mobile device is via the Bluetooth Low Energy protocol. In one implementation the software runs on a mobile phone or tablet, for example, the supported mobile device can run on an Android operating system. The audio-visual methods and solutions are implemented by using the display and the speakers of the mobile device (mobile phone or tablet). [0049] In a further implementation, the mobile device can be a complete PC architecture computer with Bluetooth communication enabled.

[0050] The currently available most integrated solution is the SpiroSonic SMART system, which embeds all hardware and software solutions together. The SpiroSonic SMART system features an embedded ultrasonic spirometer sensor, a high speed processor (advanced microcontroller), memory and all means of a small handheld computer. In addition, all audio-visual means and methods of the can be embedded in the SpiroSonic SMART system, including a touch screen graphical display functioning both as input and display output as well as two separate means of audio effects. One audio effect generator (a Buzzer) emits sounds related to system operation and basic respiratory manoeuvre support. A more advanced built-in speaker can be driven by an advanced waveform generator subsystem and is capable of playing human voice instructions and diagnostic feedback.

BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0052] Fig. 1 illustrates prior art current 2D, X Y display of spirometer measurements demonstrating a volume versus flow plot with a complex non-linear relationship not easily interpreted by non-clinicians;

[0053] Fig. 2 illustrates a working concept model demonstrating the flow and volume (optional pressure) data from a sensor, converted to a continuous musical tone reflecting changes in the flowvolume;

[0054] Fig. 3 illustrates one form of a colorful representation of the consecutive respiratory manoeuvres;

[0055] Fig. 4 illustrates a colorful graphical incentive to support optimal respiratory manoeuvres;

[0056] Fig. 5 illustrates a representation of the working concept model subsystems and modules;

[0057] Fig. 6 illustrates a representation of the audible and graphical representation of the respiratory signal;

[0058] Fig. 7 illustrates a colour coding representation of the respiratory signal; [0059] Fig. 8 illustrates an audible encoding representing the respiratory signal;

[0060] Fig. 9 illustrates schematically one form of embodiment, where the hardware (SpiroSonic FLO) is a compact ultrasonic spirometer sensor with a USB interface to a PC computer which runs the SpiroReporter software that includes audio-visual effects supporting spirometry maneuvres and interpretation;

[0061] Fig. 10 illustrates schematically one form of embodiment where the hardware (SpiroSonic AIR) is a compact ultrasonic spirometer sensor with a Bluetooth interface to a mobile phone, tablet or a PC computer which runs the SpiroSonic Mobile or SpiroReporter software that includes audiovisual effects supporting spirometry maneuvres and interpretation;

[0062] Fig. 11 illustrates schematically one form of embodiment where the hardware (SpiroSonic SMART) is an advanced integrated ultrasonic spirometer which includes both the ultrasonic spirometer sensor and all computed means of interpretation and visualization, including audio and visual effects;

[0063] Fig. 12 is a SpiroSonic system architecture diagram, describing the data flow, inputs and outputs of one form of implementation of the present invention.

[0064] Fig. 13 is a software system diagram describing the algorithms of one embodiment; and

[0065] Fig. 14 is a functionality flow diagram of the diagnostic algorithms of an actual implementation of an embodiment. The diagnostic algorithms are then the basis of the audio-visual outputs/feedback to the users as described herein.

DETAILED DESCRIPTION

[0066] The embodiments provide for the implementation of various audio and enhanced visual display incentives to improve user interpretation of results and provide direct feedback to guide and optimise user performance that are more intuitive, particularly in children, may result in improved reliability and more widespread clinical adoption of spirometry. Enhanced acoustic feedback also provides for the application of spirometry in subjects with visual impairment, while simplified and colour enhanced visual displays may be useful to those suffering deafness.

[0067] Audio Feedback: [0068] Enhanced audio feedback models may include:

[0069] Pitch Feedback: A simple pitch connection to the spirometry waveform, rising with positive velocity and falling with negative velocity.

[0070] Tone feedback: With the tone of the signal represented as a change in tone. The selected tone can match any sound such as telephone ring, dog bark, falling water etc. and can be user selected.

[0071] Volume feedback: The volume of the signal starts at 0 with nil flow, and achieves maximum at peak highest positive and peak negative velocity values.

[0072] Visual Feedback:

[0073] Enhanced visual feedback may range from simple colourised display of current volume flow plots through to complex cartoon animations, each of which may improve effective use of spirometry by providing performance feedback during examination and objective targets for the examination.

[0074] Colourisation: The coding of flow volumes of the XY plot can be colourised to reflect the numerical value of the lung function trace, with the most intense colours assigned to the highest volumes, with red positive and blue negative, with 0 volumes coded white or grey. In a more complex iteration a blank colour field, representing the flow volume, can flash a bright feedback which changes with the flow volume. This allows the clinician to preset a colour target for the examination based on prior studies so the subject objective is to achieve or exceed the preset colour target. These colourisation models can be used to establish targets for adults and children and provide performance feedback during examination.

[0075] Animations: Simple cartoon like animation may contain both breathing -feedback reinforcement and a reward for achieving a threshold or target. Some incentives use animations as response to the exhaled volume, however, the goal is not preset and only feedback when the target has been achieved. Most current incentive animations are linear and have significant limitations particularly in younger children.

[0076] The adoption of advanced audio-visual spirometer feedback will result in a wider range of feedbacks which can be more simply understood and appreciated, particularly by children, and the visually and aurally impaired. This improvement to spirometry will facilitate the cost-effective expansion of telemetric pulmonary health monitoring and the more widespread adoption of a cost- effective clinical care model for management of pulmonary disease worldwide.

[0077] Spirometry is an established method for examination of respiratory function, providing accurate pulmonary function evaluation, diagnosis of disease, and choice of optimal therapy when required. However, its reliability and repeatability is dependent on standardised operation, with inconsistent operations impacting variability across institutions, and in non-clinical environments limiting its utility.

[0078] The principle reasons for poor application in home care environments are difficulty of understanding, complicated results and low compliance. Simplifying a feedback process across acoustic and visual sensations increases the volume and nature of the feedback and may be more simply processed by some users. In paediatrics the challenge is to provide simple and engaging incentives to ensure cooperation and optimal examination. Both compliance and guidance can be facilitated by audio-visual supplementation and coding of the ultrasonic signals.

[0079] Coding can include Color for visual reinforcement of spirometry signal, and acoustic variation of volume or pitch, including Tone.

[0080] The audio-visual enhancement can range from the most simple where the sound is modulated as a musical tone according to the flow speed, while the graph can be colour coded through various shades of red and blue, e.g. red for positive flow, blue for negative flow and white for zero flow, with colour intensity graduated according to the velocity with red as positive, blue as negative, and 0= white, and peak positive bright red and peak negative bright blue graded in between according to velocity and pitch.

[0081] The graph can also be animated to provide an incentive, with the animation driven by the change of flow/volume in a dynamic manner driven by the user to achieve an optimal examination.

[0082] The acoustic feedback can be simply volume or pitch related, or can be more complex such as including a passage of music, with the music being user selected.

[0083] The acoustic feedback can also be used to guide a voice instruction system based on an automated decision support system. The automation values can be used to define the diagnosis based on the obstructive and restrictive thresholds defined by a selected academic body e.g. by the American Thoracic Society or the European Respiratory Society. [0084] With “acoustic spirosonometry” and “audio visual motivating software”, the user is provided with user reinforcement and feedback to optimise the spirometer examination, as well as providing a new, improved and simple method for diagnostic coding, which although globally applicable, is most useful for children with asthma, and the visual and aurally impaired.

[0085] Properties of the real-time generated audio signal

[0086] Different properties of the sound can be proportional with the flow intensity, frequency, series of frequencies or music tones from a scale etc.

[0087] Sinusoidal waves, where the frequency is driven by flow may generate noise from high frequency upper harmonics.

[0088] A preferable solution for this problem is: 1. use only a limited set of frequencies (e.g. music tones); 2. switch to the selected frequency then wait until the selected sinusoid wave has finished its period (phase is 0 degree / intensity is zero); 3. the new frequency then starts with the beginning of its period (phase is 0 degree / intensity is zero). This process minimises high frequency noise during frequency changes.

[0089] Implementation of advanced audio-visual feedback during examinations can be targeted to motivate individual patients and improve the reliability and repeatability of spirometry and expand its effective application in the visual and sound impaired population in adults and children.

[0090] Cases demonstrating the current invention benefits

[0091] CASE 1: Children do not respond to voice instructions like adults. However, they can respond to animation and simple acoustics.

[0092] CASE 2 -Individual patients may respond preferentially to various audio and visual stimuli depending on their life education and experience. This may be particularly important where complex physiologic manoeuvres are required

[0093] CASE 3 - Some patients, particularly children, prefer games which include audiovisual stimuli, rather than solely visual and /or audio feedback. [0094] CASE 4 - Patients with visual impairment will benefit from audio feedback while those with impaired hearing, particularly the elderly in whom COPD is highly incident.

[0095] FIG 1 shows one early concept model embodiment of a pulmonary measurement, or pulmonary evaluation, in accordance with the present invention. The software, on display on FIG. 1., receives the signal from an underlying hardware (not shown on the image), which produces a spirometry flow signal. One such design of a spirometry system can be that as described in US Patent Publication 20100095782 entitled “METHOD AND APPARATUS FOR DETERMINING THE FLOW PARAMETERS OFA STREAMING MEDUM”, the contents of which are incorporated by cross reference.

[0096] The flow (optional pressure) signal is processed into a digital data and the recorded values are displayed (in a textual format on this early concept model). The digital flow data is used for 1. calculating an integrated volume data with measured time, 2. modulating the music tone or pitch of an audible voice signal. The modulated voice signal is played on the speaker of the computer running the software.

[0097] Various embodiments of each of these elements will be recognized by persons of skill in the art. For example, the hardware can be a turbine, differential pressure or ultrasonic flow meter. The computer can be a desktop or mobile system and the speaker can be an external connected device or a built-in speaker in a mobile phone.

[0098] A more advanced embodiment of the present invention is the introduction of a graphical representation of the incentive data, in addition to the audio output. The graphical representation can be a simple area with a dedicated color, corresponding to the actual level of the flow, ranging from red to blue, while zero flow is white.

[0099] Another preferred embodiment, as exemplified in Fig. 3 is an image of the distinguished respiratory manoeuvres, processed by the software as spirometry curves.

[00100] Fig. 3 illustrates a colorful graphical incentive to support optimal respiratory manoeuvres. Forced Vital Capacity is a function of expired volume versus the volumetric speed of flow. The resulting graph is a “fingerprint” of the lung and it is unique for each and every patient. The respiratory effort (volumetric flow speed) can be used with an exponential encoding for a graphical incentive. The stronger the volumetric flow, the further the animation will progress. Any linear animation can be used as an incentive, however, the present embodiments include dynamic incentives. In a preferred embodiment a variety of graphical incentives have been implemented, a selection can be made in real time, even during a respiratory diagnostic manoeuvre.

[00101] Another aspect of Fig. 3 is a real-time visual progress bar with logarithmic steps responding to the performance of the patient. There are 9 smiley faces in a line representing 10 stages: from no face visible at all (the start, 0% of target) up to all 9 faces visible (target reached, 100%). Therefore, the progress displayed in 10 steps (from 0 - 9). The range is divided according to logarithmic scale, e.g: 0 - 0%, 1 - 30%, 2 - 48%, 3 - 61%, 4 - 70%, 75 - 8%, 6 - 85%, 7 - 92%, 8 - 96% and 9 - 100% of the awaited value (performance). The logarithmic scaling is more encouraging the children to blow out all the air from their lungs compared to a linear scaling with equal steps (0%, 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 100%). Most subjects can exhale 50% of the lung volume, while the highest level of diagnostic accuracy is only achieve with 100% exhalation. The linear scale has only 2 stages above 80%, while the logarithmic has 4; the linear scale has only 1 stage above 90%, while the logarithmic still has 3.

[00102] The performance causes more visual changes: the number of faces visible: 0 - 9, the color of face: from red (1 face is visible) to yellow, then to green (where all faces are visible), emotion on the face: for example from sad to happy face.

[00103] Fig. 3 can also include a visual progress bar (or together with it) or a “driven progress bar”. In this example, the music tones of a musical scale are played in increasing order (e.g. in C major) to represent increasing results. Practically the patient hears music tones in rising order. It might be useful for visually impaired patients. However, selecting audio, video or both audio-video incentive can be a result of a personal taste. A number of user selected motivation methods can provide more opportunities for the improved personal performance.

[00104] A hardware embodiment is illustrated schematically in Fig. 5. The respiratory flow is sampled by a flow sensor (11), and transformed into a digital data stream (12). The digital flow data is received by a computing unit (13), which may be a mobile device (e.g. mobile phone, smartwatch, tablet), a von-Neumann-architecture computer or a microcontroller-based integrated medical device (e.g. handheld or desktop). The computing unit integrates the flow speed in time and generates a volumetric data; eventually the data is visualized with a graphical representation (15), and/or an audible signal (14). Such an embodiment may be used as audio/graphical incentive to the user (patient), to facilitate the understanding of the medical diagnostic/monitoring procedure as well as to motivate the user to perform better. [00105] In another embodiment, the type of the incentive can be automatically selected by the software based on selected patient details, such as gender or age.

[00106] In another embodiment the incentive graphical representation may be a way to generate measures that can be understood by the user/patient in an intuitive way, such as progress distance of a car or another object, representing volumetric data exhaled or inhaled by the user/patient. A computer game driven by respiratory effort may provide a better alternative than a pure voice instruction of an operator - especially in paediatric spirometry. Scaled achieved scores displayed on screen may also motivate the user (through gamified spirometry). For example: a car jumping over a gap is a binary incentive: a) car jumps over the gap (success); b) jumps falls into the gap (failure). The jump is realistic (= it is based on physics) and the speed at the beginning of the gap depends on the exhaled volume then the length of the jump will differ from trial to trial (incentive is not binary anymore). The length of the jump is the “score” of the game, which is displayed in well visible manner (like in a computer game). The user becomes a gamer, who wants to make the car jump longer and longer (i.e. the gamer tries to blow out more and more). The gamer will concentrate on score, with the respiratory manoeuvre simply a tool to achieve higher and higher scores.

[00107] Fig. 6 demonstrates the preferred means of user incentive and motivation: (a) demonstrates playing a continuous voice signal and modulating the music tone and pitch with the flow volume data. While (b) demonstrates the same with graphical representation by modifying the hue/tone/tint of the color, ranging from blue (negative flow/inhalation) to red (positive flow/exhalation), while the steady state or the transition point between exhale and inhale is encoded with white color.

[00108] As depicted on Fig. 7 an optimal division of the available visual screen may be characterized by a professional FVC diagram on one half of the screen, while a color coded incentive area may be implemented on the other half.

[00109] The audio signal can be a simple sinusioid or square wave with the music tone or pitch modulated by the volumetric flow, as demonstrated in Fig. 8. In another, more complex embodiment, the processing computer may calculate high level spirometry data based on the incoming flow and it may assign an automated quality control information and/or an automated decision support information to the results, and the quality control and/or decision support can be communicated to the user with an audible voice played by the speakers. [001 10] In another preferred embodiment, the quality control information may include cough detection and/or glottis closure detection, as well as short respiratory manoeuvres, slow start, abrupt end, poor effort or leakage detection.

[001 11] In another preferred embodiment, the brightness of the mobile device (mobile phone) may be modulated by the software with the volumetric speed.

[001 12] In another preferred embodiment a favourite music clip may be pre-selected by the user and the play speed of the music clip is modulated with the expired/inhaled volume.

[001 13] The implementation of the invention can take many different forms, and is an exercise in embedded system design and development.

[001 14] For example, Fig. 9 illustrates schematically one form of embodiment, where the hardware (SpiroSonic FLO) device 90 is a compact ultrasonic spirometer sensor with a USB interface to a PC computer 91 which runs the SpiroReporter software that includes audio-visual effects supporting spirometry maneuvres and interpretation;

[001 15] Fig. 10 illustrates schematically an alternative form of embodiment where the hardware (SpiroSonic AIR) device 100 is a compact ultrasonic spirometer sensor with a Bluetooth interface to a mobile phone 103, tablet or a PC computer 102 which runs the SpiroSonic Mobile or SpiroReporter software that includes audio-visual effects supporting spirometry maneuvres and interpretation;

[001 16] Fig. 11 illustrates schematically a further alternative form of embodiment where the hardware (SpiroSonic SMART) is an advanced integrated ultrasonic spirometer 110 which includes both the ultrasonic spirometer sensor and all computed means of interpretation and visualization, including audio and visual effects. The computer device can be of a compact form;

[001 17] Whilst the software design can take many different designs, Fig. 12 illustrates one form of overally SpiroSonic system architecture diagram, describing the data flow, inputs and outputs of one form of implementation of the present invention.

[001 18] Fig. 13 illustrates an alternative form of software design for apersonal computer hardware based system arrangement, describing the algorithms of a further embodiment; and [001 19] Fig. 14 is a functionality flow diagram of the diagnostic algorithms of an actual implementation of an embodiment. The diagnostic algorithms are then the basis of the audio-visual outputs/feedback to the users as previously described.

Interpretation

[00120] Reference throughout this specification to “one embodiment”, “some embodiments” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment”, “in some embodiments” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

[00121] As used herein, unless otherwise specified the use of the ordinal adjectives "first", "second", "third", etc., to describe a common object, merely indicate that different instances of like objects are being referred to, and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner.

[00122] In the claims below and the description herein, any one of the terms comprising, comprised of or which comprises is an open term that means including at least the elements/features that follow, but not excluding others. Thus, the term comprising, when used in the claims, should not be interpreted as being limitative to the means or elements or steps listed thereafter. For example, the scope of the expression a device comprising A and B should not be limited to devices consisting only of elements A and B. Any one of the terms including or which includes or that includes as used herein is also an open term that also means including at least the elements/features that follow the term, but not excluding others. Thus, including is synonymous with and means comprising.

[00123] As used herein, the term “exemplary” is used in the sense of providing examples, as opposed to indicating quality. That is, an “exemplary embodiment” is an embodiment provided as an example, as opposed to necessarily being an embodiment of exemplary quality.

[00124] It should be appreciated that in the above description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Detailed Description are hereby expressly incorporated into this Detailed Description, with each claim standing on its own as a separate embodiment of this invention.

[00125] Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those skilled in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

[00126] Furthermore, some of the embodiments are described herein as a method or combination of elements of a method that can be implemented by a processor of a computer system or by other means of carrying out the function. Thus, a processor with the necessary instructions for carrying out such a method or element of a method forms a means for carrying out the method or element of a method. Furthermore, an element described herein of an apparatus embodiment is an example of a means for carrying out the function performed by the element for the purpose of carrying out the invention.

[00127] In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

[00128] Similarly, it is to be noticed that the term coupled, when used in the claims, should not be interpreted as being limited to direct connections only. The terms "coupled" and "connected," along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Thus, the scope of the expression a device A coupled to a device B should not be limited to devices or systems wherein an output of device A is directly connected to an input of device B. It means that there exists a path between an output of A and an input of B which may be a path including other devices or means. "Coupled" may mean that two or more elements are either in direct physical or electrical contact, or that two or more elements are not in direct contact with each other but yet still co-operate or interact with each other. [00129] Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognize that other and further modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as falling within the scope of the invention. For example, any formulas given above are merely representative of procedures that may be used. Functionality may be added or deleted from the block diagrams and operations may be interchanged among functional blocks. Steps may be added or deleted to methods described within the scope of the present invention.