AU2023201955B1

AU2023201955B1 - Device, method and system for detecting sound or audio waves

Info

Publication number: AU2023201955B1
Application number: AU2023201955A
Authority: AU
Inventors: Peter Albert HVALA; Justin MORTON; Eric Sai Kin SHUM
Original assignee: Corsonys Pty Ltd
Current assignee: Corsonys Pty Ltd
Priority date: 2023-03-30
Filing date: 2023-03-30
Publication date: 2023-12-14
Anticipated expiration: 2043-03-30

Abstract

An auscultation device, method and system comprising a housing defining one or more cavity, one or more microphone disposed inside the one or more cavity and an input disposed on or in the housing, the input for receiving one or more electrocardiography (ECG) cables is described. Also described is an auscultation device, method and system comprising a housing defining a cavity, a microphone disposed inside the cavity to detect sound or acoustic waves, an acoustic concentrator comprising a mouth and a neck, the acoustic concentrator disposed on an auscultation side of the housing to direct sound or acoustic waves to the microphone a diaphragm spanning the mouth of the acoustic concentrator and a grommet providing a hermetic seal for the auscultation device. Further described are a similar device, method and system with a primary microphone and a secondary microphone disposed in the cavity to capture ambient sound.

Description

CORSONYS PTY. LTD. AUSTRALIA

Patents Act 1990

COMPLETE SPECIFICATION FOR THE INVENTION ENTITLED "DEVICE, METHOD AND SYSTEM FOR DETECTING SOUND OR AUDIO WAVES"

This invention is described in the following statement:-

DEVICE, METHOD AND SYSTEM FOR DETECTING SOUND OR ACOUSTIC WAVES FIELD OF THE INVENTION

[0001] The present invention relates to a device, method and system for detecting sound or acoustic waves. In one embodiment, this invention relates to an auscultation device, method and system comprising one or more microphone to capture auscultation sound or acoustic waves and an, optionally, an input for receiving one or more electrocardiography (ECG). In another embodiment, this invention relates to an auscultation device, method and system comprising one or more microphone, an acoustic concentrator, a diaphragm and a grommet.

BACKGROUND TO THE INVENTION

[0002] Recording biosignals can allow the early, or otherwise, detection of diseases, disorders or conditions. The detection, in particular early detection, of these disease, disorders and conditions may result in better prognosis and in cost efficiencies through more successful treatment.

[0003] Cardiovascular diseases, such as arrhythmia, valvular heart disease, rheumatic heart disease and ischemic heart disease, affect more than 15% of the global population. Too many people discover their heart condition too late, and routine screening for cardiovascular disease in asymptomatic patients is uncommon. Cardiac tests conducted by specialists, such as electrocardiograms, echocardiograms, stress tests and angiograms, are not easily accessible by the public and general practice. As a result, healthcare systems require patients to present with symptoms before tests are prescribed, at which point the condition could already be severe. For patients with existing chronic cardiac conditions, home monitoring devices such as, blood pressure and Holter monitors offer very little information to help manage their cardiovascular health.

[0004] One system and method for the detection of coronary artery and other diseases using both acoustic and electrical data is described in International Patent Application No.: PCT/US2016/048937, published as W02017/040262. This document to AUM CARDIOVASCULAR, INC. discloses a data collection device, which may be handheld, comprising an acoustic sensor panel, an electrocardiogram (ECG) sensor panel and a processor to analyse the outputs of the sensor panels and provide a qualitative result related to an indication of an anatomical or physiological characteristic. The device may also include a microphone to compensate for ambient noise and vibrations and/or a second acoustic sensor for detecting a turbulent pressure wave in a coronary artery.

[0005] Other earlier applications to this Applicant describe similar devices (PCT/US2015/047530 published as WO 2016/033521; PCT/US2012/050122 published as WO 2013/023041; and PCT/US2010/059412 published as WO 2011/071989). Some of these devices have a separate ECG device, which may be coupled to the Coronary Artery Disease (CAD) device which comprises an internal acoustic sensor.

[0006] United States Patent No.: 8870792, to Masimo Corporation, is directed to a physiological monitoring system which receives physiological data from one or more acoustic sensors, down-samples the data to generate raw audio of breathing sounds and compresses the raw audio. Other data inputs may be provided by optical, blood pressure, electroencephalogram (EEG) and ECG sensors. Dual channel acoustic sensors may be utilised with one sensor for deriving one or more physiological parameters such as, respiration rate, and the second to continuously monitor body sounds.

[0007] United States Patent No.: 8911383, to Acarix A/S, discloses an adhesive patch for monitoring acoustic signals. The patch comprises a protective layer, an adhesive layer, a microphone disposed to be pressed to the skin surface, a resilient pad, and a controlling unit connected to both the microphone and a second microphone used to record environmental noise.

[0008] United States Patent No.: 9566041, also to Acarix A/S, also discloses an adhesive patch for monitoring acoustic signals.

[0009] International Patent Application No.: PCT/EP2017/064834, published as WO/2017/216374, also to Acarix A/S, discloses quantifying the function of a beating heart by recording a signal with an accelerometer placed on the chest of a person. A plurality of segments of the signal are formed, which are aligned and filtered with a band-pass filter having a lower cutoff frequency below 1 Hz and an upper cut-off frequency in the range 100 to 250 Hz. A mean segment is then determined, in which a first temporal feature is determined. A measure is then determined based on at least one of the signal value, or amplitude, of the first temporal feature and the location in time of the first temporal feature. The determined measure is then provided as output information. An audio signal and ECG signal may also be recorded with a microphone placed on the chest and configured for measuring cardiovascular sounds.

[0010] Other earlier applications to Acarix A/S describe similar devices including those comprising optical beams and disposed on adhesive patches (PCT/EP2016/057798 published as WO/2016/162503; PCT/EP2013/062467 published as WO/2013/189866; PCT/EP2011/072537 published as WO 2012/080209; and PCT/EP2010/064600 published as WO 2011/039329).

[0011] US Patent No.: 9955887 to iRhythm Technologies, Inc discloses a flexible body with flexible electrodes in each of two wings extending laterally from the body for obtaining ECG or comparable biological signals.

[0012] There is a need for alternative or improved devices, methods and systems for detecting biosignals.

[0013] The reference to any prior art in this specification is not, and should not be taken as, an acknowledgement or any form of suggestion that the prior art forms part of the common general knowledge.

SUMMARY OF THE INVENTION

[0014] Generally, embodiments of the present invention relate to a device, method and system for detecting sound or acoustic waves.

[0015] In one broad form, the invention relates to an auscultation device, method and system comprising one or more microphone to capture auscultation sound or acoustic waves and, optionally, an input for receiving one or more electrocardiography (ECG) cable.

[0016] In another broad form, this invention relates to an auscultation device, method and system comprising one or more microphone, an acoustic concentrator, a diaphragm and a grommet.

[0017] In a first aspect, although it need not be the only or indeed the broadest form, the invention provides an auscultation device comprising: a housing defining one or more cavity; one or more microphone disposed inside the one or more cavity, each of the one or more microphone detecting sound or acoustic waves; an input disposed on or in the housing, the input for receiving one or more electrocardiography (ECG) cables, each of the one or more ECG cables disposed to provide detected ECG signals obtained from one or more ECG electrode; and a processor for receiving an auscultation input comprising the detected sound or acoustic waves from the one or more microphone and an ECG input comprising the received ECG signals.

[0018] Ina second aspect, the invention provides an auscultation method comprising: detecting sound or acoustic waves with one or more microphone disposed inside a cavity defined within a housing; receiving an auscultation input comprising the detected sound or acoustic waves from the one or more microphone; and receiving an ECG input comprising received ECG signals, the ECG signals provided as detected ECG signals obtained from one or more ECG electrode connected to respective one or more electrocardiography (ECG) cables received in an input disposed on or in the housing.

[0019] In a third aspect, the invention provides an auscultation system for detecting sound or acoustic waves, the system comprising: a housing for defining a cavity; one or more microphone for detecting sound or acoustic waves, each of the one or more microphone disposed inside the cavity; an input for receiving one or more electrocardiography (ECG) cables, the input disposed on or in the housing, each of the one or more ECG cables disposed to provide detected ECG signals obtained from one or more ECG electrode; and a processor for receiving an auscultation input comprising the detected sound or acoustic waves from the one or more microphone and an ECG input comprising the received distal ECG signals.

[0020] According to any one of the first to third aspects, the one or more microphone may comprise a primary microphone to capture sound or acoustic waves and a secondary microphone to capture ambient sound.

[0021] According to any one of the first to third aspects, an acoustic concentrator comprising a mouth and a neck may be comprised. The acoustic concentrator may be disposed on an auscultation side of the housing to direct sound or acoustic waves to the one or more microphone, optionally the primary microphone.

[0022] According to any one of the first to third aspects, a diaphragm may span the mouth of the acoustic concentrator.

[0023] According to any one of the first to third aspects, a grommet may provide a hermetic seal. The grommet may be disposed on the auscultation side of the housing. The grommet may comprise a primary chamber to secure the acoustic concentrator. The grommet may comprise a secondary chamber disposed to direct sound or acoustic waves to the secondary microphone.

[0024] According to any one of the first to third aspects, the housing may define a cavity. The housing may comprise an auscultation side for contact with a subject producing bodily sounds and an opposing hand-held side.

[0025] In a fourth aspect, the invention provides an auscultation device comprising: a housing defining a cavity, the housing having an auscultation side for contact with a subject producing bodily sounds and an opposing hand-held side; a microphone disposed inside the cavity to detect sound or acoustic waves; an acoustic concentrator comprising a mouth and a neck, the acoustic concentrator disposed on an auscultation side of the housing to direct sound or acoustic waves to the microphone; a diaphragm spanning the mouth of the acoustic concentrator; and a grommet on the auscultation side of the housing, the grommet providing a hermetic seal for the auscultation device.

[0026] In a fifth aspect, the invention provides an auscultation method comprising: directing sound or acoustic waves to a microphone with an acoustic concentrator, the microphone disposed inside a cavity defined in a housing, the housing having an auscultation side for contact with a subject producing bodily sounds and an opposing hand held side, the acoustic concentrator comprising a mouth and a neck, with a diaphragm spanning the mouth of the acoustic concentrator wherein the acoustic concentrator is disposed on the auscultation side of the housing and wherein a grommet is disposed on the auscultation side of the housing, the grommet providing a hermetic seal for the auscultation device; and detecting the sound or acoustic waves with the microphone.

[0027] In a sixth aspect, the invention provides an auscultation system for detecting sound or acoustic waves, the system comprising: a microphone for detecting sound or acoustic waves, the microphone disposed inside a cavity defined in a housing, the housing having an auscultation side for contact with a subject producing bodily sounds and an opposing hand-held side; an acoustic concentrator for directing sound or acoustic waves to the microphone, the acoustic concentrator comprising a mouth and a neck, with a diaphragm spanning the mouth of the acoustic concentrator wherein the acoustic concentrator is disposed on the auscultation side of the housing; and a grommet for providing a hermetic seal for the auscultation device, the grommet disposed on the auscultation side of the housing.

[0028] In a seventh aspect, the invention provides an auscultation device comprising: a housing defining a cavity; a primary microphone disposed in the cavity, the primary microphone capturing sound or acoustic waves; an acoustic concentrator comprising a neck disposed to direct sound or acoustic waves to the primary microphone; a secondary microphone disposed in the cavity, the secondary microphone capturing ambient sound; and a grommet comprising a chamber disposed to direct ambient sound to the secondary microphone.

[0029] In an eighth aspect, the invention provides an auscultation method comprising: directing sound or acoustic waves to a primary microphone with an acoustic concentrator comprising a neck disposed to direct sound or acoustic waves to the primary microphone; capturing sound or acoustic waves with the primary microphone, the primary microphone disposed in a cavity defined within a housing; directing ambient sound to a secondary microphone with a grommet comprising a chamber; and capturing ambient sound with the secondary microphone disposed in the cavity.

[0030] In a ninth aspect, the invention provides an auscultation system for detecting sound or acoustic waves, the system comprising: an acoustic concentrator for directing sound or acoustic waves to a primary microphone, the acoustic concentrator disposed in a cavity defined in a housing and the acoustic concentrator comprising a neck disposed to direct sound or acoustic waves to the primary microphone; the primary microphone for capturing sound or acoustic waves, the primary microphone disposed in the cavity; a grommet for directing ambient sound to a secondary microphone, the grommet comprising a chamber disposed to achieve the direction; and the secondary microphone for capturing ambient sound, the secondary microphone disposed in the cavity.

[0031] According to any one of the fourth to ninth aspects, the housing comprises an input for receiving one or more ECG cables. Each of the one or more ECG cables may be disposed to provide detected ECG signals obtained from one or more ECG electrode.

[0032] According to any one of the above aspects, the detected ECG signals may be of electrical activity of said heart. Each of the one or more ECG electrode may be an external ECG electrode. Each external ECG electrode may be applied some distance from the auscultation device.

[0033] According to any one of the fourth to ninth aspects, a processor for receiving an auscultation input may be comprised. The received auscultation input may comprise the detected sound or acoustic waves from the one or more microphone. The processor may also receive an ECG input comprising the received distal ECG signals.

[0034] According to any one of the above aspects, the auscultation device may comprise a digital stethoscope.

[0035] According to any one of the above aspects, the grommet may secure the acoustic concentrator in a primary chamber. The hermetic seal may secure the acoustic concentrator in position with respect to the grommet.

[0036] According to any one of the above aspects, the grommet may comprise a grommet body. The grommet body may comprise a primary chamber comprising complementary dimensions to the neck of the acoustic concentrator. The primary chamber may receive the acoustic concentrator to secure the acoustic concentrator in position to direct the sound or acoustic waves. The sound or acoustic waves may be directed to the primary microphone. The concentrator may fit within the grommet body in a secure manner. The fit may comprise an interference fit. The fit may be aided by one or more complementary integrated structural fastener inter-fitting between the grommet body and the acoustic concentrator.

[0037] According to any one of the above aspects, the grommet may further comprise a secondary chamber dimensioned to direct ambient sound to the secondary microphone. The secondary chamber may be dimensioned to direct ambient sound of a similar character recorded by the primary microphone as noise.

[0038] According to any one of the above aspects, the sound or acoustic waves may access the primary microphone through a primary microphone feed channel. The primary microphone feed channel may access the primary chamber and the primary microphone.

[0039] In another embodiment of any one of the above aspects, a primary microphone depressurisation channel is comprised. The primary microphone depressurisation channel may access the housing cavity and the primary chamber.

[0040] According to any one of the above aspects, the sound or acoustic waves may access the secondary microphone through a secondary microphone feed channel. The secondary microphone feed channel may access the secondary chamber and the secondary microphone.

[0041] In another embodiment of any one of the above aspects, a secondary microphone depressurisation channel is comprised. The secondary microphone depressurisation channel may access the housing cavity and the secondary chamber.

[0042] In a particular embodiment of any one of the above aspects, the grommet may mate flush with the housing. The grommet may provide a hermetic or airtight seal. The hermetic or airtight seal may comprise an external seal and an internal seal. The external seal may be with the grommet and the housing and with the grommet and the diaphragm. The internal seal may be with the grommet and the housing or an internal component of the device. The internal seal may comprise double-sided tape.

[0043] According to any one of the above aspects, the acoustic concentrator may be funnel shaped. The acoustic concentrator mouth may have a circumference which reduces from an external opening to the neck. The neck may have a constant circumference along its length. The acoustic concentrator may comprise a wall such as, a continuous wall, comprising an external surface and an internal surface.

[0044] According to any one of the above aspects, the diaphragm may comprise a membrane. The membrane may be dimensioned to extend across the extent of the mouth. The membrane may contact the body producing the bodily sound.

[0045] In another embodiment of any one of the above aspects, the diaphragm comprises a bumper. The bumper may be overmolded to the diaphragm. The attachment of the bumper to the diaphragm may be aided by a flange disposed on bumper. The attachment of the bumper to the external auscultation side of the acoustic concentrator, at mouth, may be aided by lip. The attachment of the bumper to the acoustic concentrator may be aided by one or more complementary integrated structural fastener inter-fitting between the bumper and the acoustic concentrator.

[0046] In yet another embodiment of any one of the above aspects, the concentrator diaphragm is a one-piece concentrator-diaphragm. The one-piece concentrator may be an integral one-piece concentrator-diaphragm. The integral one-piece concentrator-diaphragm may be manufactured as an integral unit or may comprise a concentrator-diaphragm assembly. The concentrator-diaphragm assembly may be a unified assembly. The concentrator-diaphragm may be inserted and removed in the assembled, unified state.

[0047] According to any one of the above aspects, the bumper-diaphragm may be fastened to the acoustic concentrator. The fastening may be by one or more of heat sealing, welding, gluing or fusing. The heat sealing or welding may be comprise melting along the circumference of the diaphragm adjoining the mouth.

[0048] The grommet, concentrator and diaphragm may be securely fastened together.

[0049] According to any one of the above aspects, the neck of the concentrator may align with the primary microphone and/or primary microphone feed channel. The alignment may be coaxial. The primary microphone feed channel and a central axis of the neck of the concentrator may be positioned at a center, or at about a center, of the device.

[0050] According to any one of the above aspects, the acoustic concentrator may be comprised of metal or polymer.

[0051] In one embodiment of any one of the above aspects, the bumper may be comprised of rubber or polymer.

[0052] In yet another embodiment of any one of the above aspects, the diaphragm may be comprised of polymer or composite rigid material.

[0053] According to any one of the above aspects, the housing may comprise a two-piece housing and the device may further comprise a housing seal disposed between said two pieces. The housing seal may be comprised of a polymer such as a rubber.

[0054] In one embodiment of any one of the above forms, the housing may further comprise an input seal for an input disposed on or in the body. The input seal may comprise an O-ring.

[0055] In another embodiment of any one of the above aspects, the input comprises a socket.

[0056] According to any one of the above aspects, at least one of heart rate and/or respiration rate may also be detected. The heart rate may be detected with the one or more ECG cables. The respiration detection may be by impedance pneumography.

[0057] According to any one of the above aspects, auscultation data and ECG data may be synchronized. The synchronization may comprise time stamping to a single reference clock or multiplexing. The internal clock may be comprised on the device or a computing device. The timing may comprise timing the start and finish of the sound or acoustic waves and/or ECG signals. The detected sound or acoustic waves and/or ECG signals may be recorded with a timestamp. The timestamp may be at regular time intervals. The timestamp may be referenced to the internal clock.

[0058] According to any one of the above aspects, two or more ECG cables, such as two, three, or four ECG cables may be connected to the device. In one particular embodiment, multiple ECG cables may be connected, or connectable, to the device.

[0059] In one particular embodiment of any one of the above aspects, the housing may be configured so that it is manoeuvrable by hand from one position to another position on a subject.

[0060] According to any one of the above aspects, the ambient sound may be subtracted from the detected sound or acoustic waves. The ambient sound subtracted or cancelled may be noise generated within the auscultation device such as by internal air and/or the auscultation device itself.

[0061] According to any one of the above aspects the sound or acoustic waves may be processed. The processing may comprise one or more of active and passive noise cancellation The processing may comprise one or more filter. The one or more filter may comprise a high pass filter and/or a low pass filter.

[0062] According to any one of the above aspects, the device, method or system may further comprise one or more sensors. The one or more sensors may comprise one or more optical sensors; one or more gyroscopes; one or more near-infrared spectroscopy (NIRS) sensors; one or more transmission photoplethysmography sensors; one or more magnetometers and/or or one or more accelerometers. Data from the one or more sensors may be correlated with the detected sound or acoustic waves and/or ECG signals. The one or more NIRS sensors may be used to assess levels of tissue oxygenation and/or cerebral blood flow.

[0063] Each respective sensor of the one or more sensors may be connected by one or more wire or wirelessly to the device.

[0064] According to any one of the above aspects, ballistocardiography may be used.

[0065] According to any one of the above aspects, sound or acoustic waves comprise one or more bodily sound and ambient sound.

[0066] In another embodiment of any one of the above aspects, ambient sound comprises ambient noise.

[0067] According to any one of the above aspects, the sound or acoustic waves may comprise one or more internal bodily sound. The internal bodily sound may comprise one or more of a circulatory system sound; a respiratory system sound; and/or a gastrointestinal sound. The circulatory system sound may comprise cardiac sound. The cardiac sound may comprise at least one of heart valve sound and/or coronary artery sound. The internal bodily sound, circulatory system sound, respiratory system sound and a gastrointestinal sound may comprise a normal or typical sound and/or a disease or condition sound. The coronary artery sound may comprise a normal or typical coronary artery sound such as normal blood flow. The coronary artery sound may comprise a coronary artery disease or condition sound such as, turbulent blood flow.

[0068] According to any one of the above aspects, the circulatory system sound may comprise one or more of a heart beat sound and a blood flow sound. The heart beat sound may comprise a normal or typical heart sound such as, one or more valve closing sound. The one or more valve closing sound may comprise the first heart sound and/or the second heart sound. The heart beat sound may also comprise a cardiovascular disease or condition sound such as one or more of the third heart sound; the fourth heart sound; one or more click; and/or one or more rub.

[0069] According to any one of the above aspects, the respiratory system sound may comprise one or more of a larynx or laryngeal sound; a tracheal sound; and a bronchial sound.

[0070] According to any one of the above aspects, the gastrointestinal sound may comprise a bowel sound.

[0071] The device may comprise a memory for recording and storing the detected sound or acoustic waves. The detected sound or acoustic waves may be recorded and stored.

[0072] The device may comprise a transmitter or transceiver for communicating the detected sound or acoustic waves to a computing device. The transmitter or transceiver may communicate wirelessly. The transmitter or transceiver may communicate additional data such as, detected ECG signals and/or respiration rate.

[0073] The device may further comprise sound insulating material.

[0074] The device may comprise a contact surface.

[0075] The device and/or computing device may comprise a display. The display may comprise a battery indicator. The display may present a visualisation of the detected sound or acoustic waves or of the detected ECG signals, such as a phonocardiogram (PCG) and/or an electrocardiogram (ECG).

[0076] In one embodiment of any one of the above aspects, an analysis of the detected sound or acoustic waves and/or detected ECG signals is performed and a result is displayed. The displayed result may comprise a diagnostic result; a prognostic result and/or an indication of a disease or condition. The displayed result may comprise one or more of heart rate; heart rate variability; and respiration rate. The diagnostic result, prognostic result and/or indication may be provided for one or more of arrythmia; valvular heart disease (VHD); rheumatic heart disease (RHD); coronary artery disease (CAD); heart failure and/or cardiomyopathy.

[0077] The device and/or computing device may communicate with one or more Electronic Medical Record (EMR) and/or Electronic Health Record (EHR) platforms.

[0078] The device and/or computing device display may present a graphical user interface (GUI). The GUI may receive commends for performing desired operations.

[0079] The subject may comprise a human or non-human animal. The non-human animal may comprise a companion animal; a livestock animal; a performance animal; and/or a zoological animal. The performance animal may comprise a racehorse or a greyhound. The zoological animal may comprise an animal housed at a zoo.

[0080] Further aspects and/or features of the present invention will become apparent from the following detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0081] In order that the invention may be readily understood and put into practical effect, reference will now be made to embodiments of the present invention with reference to the accompanying drawings, wherein like reference numbers refer to identical elements. The drawings are provided by way of example only, wherein:

[0082] Figure 1A: is a photograph showing one embodiment of an auscultation device according to the invention.

[0083] Figure IB: is an bottom perspective view showing another embodiment of an auscultation device according to the invention.

[0084] Figure IC: is a partial section view showing an embodiment of an auscultation device according to the invention.

[0085] Figure ID: is a section view of the concentrator-diaphragm assembly according to one embodiment of the invention.

[0086] Figure 1E: is a perspective view of concentrator-diaphragm assembly shown in Figure 1C.

[0087] Figure IF: is a perspective view of the grommet which will be housed in auscultation device according to one embodiment of the invention.

[0088] Figures 2A and 2B: are schematic diagrams showing one embodiment of a computing device and computer network according to the invention.

[0089] Skilled addressees will appreciate that elements in the drawings are illustrated for simplicity and clarity and have not necessarily been drawn to scale. For example, the relative dimensions of some elements in the drawings may be distorted to help improve understanding of embodiments of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0090] The present invention provides a device, method and system for detecting sound or acoustic waves.

[0091] In one embodiment, this invention provides an auscultation device, method and system comprising one or more microphone to capture auscultation sound or acoustic waves and an, optionally, an input for receiving one or more electrocardiography (ECG) cable.

[0092] In another embodiment, this invention provides an auscultation device, method and system comprising one or more microphone, an acoustic concentrator, a diaphragm and a grommet.

[0093] Stethoscopes have been in use for over two hundred years by physicians to listen to bodily sounds to diagnose a wide range of diseases. When listening to heart sounds, there are four traditional heart auscultation areas that a physician will listen to.

[0094] The advent of digital stethoscopes has paved the way for more advanced auscultation of heart sounds, enabling functionality previously unavailable with a traditional stethoscope, some of which include: adjustable amplification levels; recording and playback; storage and sharing of sound recordings; and visualisation of recorded sounds.

[0095] While the above have provided significant improvements to auscultation, one particular challenge that has not been fully resolved is the issue of ambient noise. The major challenge is in how to accurately remove background noise from the sound recordings.

[0096] An auscultation device, regardless of the setting where it is used will capture some undesirable ambient noise. The ambient sound may either enter the auscultation device directly from the surroundings, or through contact with the patient's body.

[0097] Digital stethoscopes allow for data to be recorded, stored and transferred for further processing or analysis. Some digital stethoscopes implement wireless file transfer protocols to achieve this. The digital stethoscopes which only capture audio signals will record only audio data. In some embodiments, the device, method and system described herein provides the recording of both audio and electrocardiography (ECG) data, which may require some form of temporal synchronisation to enable meaningful analysis.

[0098] Electrocardiography (ECG or EKG) is the process of recording the electrical activity of the heart using electrodes placed over the skin. The electrodes detect changes in the electrical activity of the heart caused by depolarization and repolarization waves of the heart.

[0099] Advantageously, in one embodiment, the present invention achieves comprehensive cardiac screening, by providing a single device 100 that allows independent placement of multiple sensors for simultaneous and synchronised capture of the following bio-signals: bodily sounds, including heart sounds, lung sounds, gastro sounds; heart rate; and respiratory rate. This may be achieved by providing an auscultation device 100 that allows ECG cables 104 to be attached to it, and which allows fixed and consistent ECG capture while maintaining its mobile auscultation feature. By attaching the ECG cables 104 to the auscultation device, the single device 100 can independently capture the patient's ECG while auscultation is being performed at various locations on the body. Noise reduction - Ambient noise through air

[00100] Sound waves can travel through a medium such as, gases and solids. This often compromises the quality of bodily sounds captured by non-invasive techniques, significantly affecting their accuracy and overall efficacy / reliability.

[00101] Device 100 comprises a uniquely designed housing 110 and grommet 180 which prevent most of the ambient noise travelling into it through air, by sealing off housing 110. In one embodiment, this is achieved through the use of: * a rubber housing seal 114 (not shown) where the top and bottom halves of the housing meets; * an input seal 116 (not shown), in the form of an O-ring, between the ECG input 102 and the enclosure; and * a multi-purpose grommet 180 that provides a hermetic seal 190. Noise cancellation - Ambient noise through solids / vibration of the enclosure:

[00102] When the housing 110 is fully sealed, there may still be residual ambient noise that is transferred to the primary microphone 130 through the vibration of the housing 110 and the air within. This transfer occurs through the depressurising holes of the primary microphone, that is the primary microphone feed channel 120 and the primary microphone depressurisation channel 122, which are in turn a necessary component of device 100. To overcome this problem, the inventor has incorporated a secondary microphone 140 to cancel any residual ambient noise transferred directly through the solids and/or the air within housing 110.

[00103] For noise cancellation to work at an optimum level, the ambient noise experienced by the primary microphone 130 may need to be mimicked by the secondary microphone

140. To achieve this, grommet 180 comprises a hollow chamber or primary chamber 186 that has a similar diameter and depth as the neck 154 of the concentrator 150.

[00104]In addition to its noise reduction and noise cancellation features, grommet 180 serves to hold and secure the assembled concentrator-diaphragm 150, 160. Advantageously, grommet 180 may mate flush without the use of screws to minimise loose parts. In other words, grommet 180 of the invention has been uniquely designed to perform several important functions at the same time, including: a) hermetically seals off the external interface of the casing 110, b) includes a secondary chamber 186 which allows for the secondary microphone 140 to capture ambient sound of a similar character to noise recorded by the primary microphone 130; and c) hold and secure the assembled concentrator-diaphragm 150, 160.

[00105]FIGS. 1A; 1B; IC; ID; and 1E show one embodiment of an auscultation device 100 according to the invention. Device 100 is provided in a small handheld format comprising housing 110 which defines cavity 112. As shown, in FIG. 1A housing 110 comprises an auscultation side 110a for contact with a subject producing bodily sounds and an opposing hand-held side 1Ob. The auscultation side 1Oa comprises a contact surface 118.

[00106] The exploded view of FIG. B and the partial section view of FIG. IC show the primary 130 and secondary microphones 140 disposed inside the cavity 112, such that each of the microphones 130, 140 are able to detect audio.

[00107] The primary microphone 130 may capture sound or acoustic waves, while the secondary microphone 140 may capture ambient sound.

[00108]From the teaching herein, the skilled person readily understands that sound or acoustic waves may comprise one or more bodily sound and ambient sound. The ambient sound may comprise ambient noise.

[00109] Also shown in FIG. 1A is an input 102, in the form of a socket, disposed on or in housing 110, for receiving one or more electrocardiography (ECG) cables 104. Although not demonstrated in the figures, each of the two or more ECG cables 104 may be disposed to provide detected ECG signals obtained from two or more ECG electrodes 106.

[00110] Although not shown in FIGS. 1A to 1E; a processor 205, see FIGS. 2A and 2B, is comprised for receiving an auscultation input comprising the detected sound or acoustic waves from the primary and secondary microphones 130, 140 and an ECG input comprising the received distal ECG signals. As will be elucidated below, the received auscultation input may comprise the detected sound or acoustic waves from primary and secondary microphones 130, 140. The processor 2015 may also receive an ECG input comprising the received distal ECG signals.

[00111] Acoustic concentrator 150 is shown to comprise a mouth 152 and a neck 154 and is disposed on an auscultation side 110a of housing 110 to direct sound or acoustic waves to the primary microphone 130.

[00112] FIG. IC illustrates how diaphragm 160 spans mouth 152 of acoustic concentrator 150. Diaphragm comprises membrane 162 which is dimensioned to extend across the extent of the mouth 152. In use, membrane 162 may contact the body producing the bodily sounds.

[00113] Turning to FIGS. ID and 1E diaphragm 160 is shown to comprise bumper 170 which is overmolded to diaphragm 160. The attachment of bumper 170 to the diaphragm 160 is aided by flange 174 disposed on bumper 170. The attachment of bumper 170 to the external auscultation side of acoustic concentrator 150, at mouth 152, is aided by lip 174. The attachment of bumper 170 to acoustic concentrator 150 is aided by one or more complementary integrated structural fastener 172, 156 inter-fitting between bumper 170 and acoustic concentrator 150.

[00114] The concentrator-diaphragm assembly 150, 160 may be a unified assembly, which advantageously, may be inserted and removed in the assembled, unified state.

[00115] To further secure the unified concentrator-diaphragm 150, 160 they may fastened together by gluing or fusing.

[00116] Advantageously, grommet 180 provides a hermetic seal for auscultation device 100. Grommet 180 is be disposed on auscultation side 1Oa of housing 110 and comprises secondary chamber 186 disposed to direct sound or acoustic waves to the secondary microphone 140.

[00117] As shown in FIG. IC grommet 180 comprises a grommet body 182 comprising a primary chamber 184 which has complementary dimensions to neck 154 of the acoustic concentrator 150. The primary chamber 184 is dimensioned to receive acoustic concentrator 150 to secure the acoustic concentrator 150 in position to direct the sound or acoustic waves. The concentrator 150 may fit within grommet body 182 in a secure manner. The fit may comprise an interference fit and is aided by one or more complementary integrated structural fastener 188, 156 inter-fitting between the grommet body 180 and acoustic concentrator 150.

[00118] The acoustic pathway arrows shown in FIG. IC show the pathway for internal noise to primary microphone 130 and secondary microphone 140.

[00119]FIG. IC shows secondary chamber 186 to be dimensioned to direct sound or acoustic waves to the secondary microphone. Secondary chamber 186 is dimensioned to direct similar sound or acoustic waves to the secondary microphone 140 as are directed to the primary microphone 130 by the primary chamber 184.

[00120] Returning to the acoustic pathway arrows on FIG. IC the sound or acoustic waves access the primary microphone 130 through primary microphone feed channel 120, which provides access to the primary chamber 184 and primary microphone 130. Also shown is primary microphone depressurisation channel 122 which provides access to housing cavity 112 and primary chamber 184.

[00121] The other acoustic pathway arrow on FIG. IC shows sound or acoustic waves accessing secondary microphone 140 through secondary microphone feed channel 124, which provides access to secondary chamber 186 and secondary microphone 140. Also shown is secondary microphone depressurisation channel 126 which provides access to housing cavity 112 and secondary chamber 186.

[00122] Grommet 180 is pictured mating flush with housing 110 which assists with providing the hermetic or airtight seal. The hermetic or airtight seal comprises interference fit 190a and an internal seal 190b. The interference fit 190a is with grommet 180 and the housing 110 and with grommet 180 and acoustic concentrator 150. The internal seal 190b is with the grommet and the housing 110 or an internal component of the device. The internal seal may comprise double-sided tape.

[00123] FIGS. IC; ID; and 1E illustrate the funnel shape of acoustic concentrator 150. The acoustic concentrator mouth 152 has a circumference which reduces from an external opening to neck 154. The neck 154 is shown to have a constant circumference along its length. The acoustic concentrator 150 is shown to comprise a wall 157 in this embodiment, a continuous wall, comprising an external surface 158 and an internal surface 159.

[00124] In the embodiment shown in FIGS. 1A to 1E, device 100 comprises a diaphragm concentrator 160,150 assembly which overcomes a shortcoming of existing stethoscope designs which impede the mobility and therefore the usability of a handheld heart screening device. Advantageously, diaphragm-concentrator 160,150 assembly ensures the user-friendliness of multi-function handheld heart screening device 100, and the quality of the data capture. The present inventor has achieved this by designing an integrated, concentrator-diaphragm 160,150. As will be elucidated below, this provides several advantages.

[00125] The novel diaphragm-concentrator 150, 160 assembly advantageously overcomes the problem posed by a conventional 90-degree chestpiece angle present in traditional stethoscope designs, as well as the need to auscultate on different locations of the patient's body while the ECG cables 104 remain attached to the patient.

[00126] One of these advantages is device-part compatibility. The one-piece diaphragm concentrator 160,150 ensures that device 100 is always used with the best fitting parts thus protecting the integrity of its function and quality of data captured. This may also prevent replacement of parts with generic components which can compromise the function of device 100 and therefore quality of the data captured.

[00127] Advantageously, one-piece diaphragm-concentrator 160,150 assembly is easy to service in case of fault, wear and tear, etc. The one-piece assembly 160,150 is easily attached and removed, without the need for additional or extraneous fasteners, thus reducing the risk of human error and improving the manufacturing process.

[00128] Another integrated assembly may be made by integrating grommet 180 with diaphragm 160 and concentrator 150 by securely fastening them together.

[00129]As shown in FIG. IC, neck 154 of concentrator 150 aligns with primary microphone 150 and 120 feed channel. The alignment is shown to be coaxial. In the embodiment shown, primary microphone 130 primary microphone feed channel 120 and a central axis of the neck 154 are positioned at or about a center of device 100.

[00130]In the embodiment shown, acoustic concentrator 150 is comprised of a polymer. From the teaching herein, a skilled person is readily able to select another suitable material such as, a metal.

[00131]In the embodiment shown, bumper 170 is shown to be comprised of a polymer. From the teaching herein, a skilled person is readily able to select other suitable materials.

[00132] Diaphragm 160 is shown to comprised of a polymer. From the teaching herein, a skilled person is readily able to select another suitable material such as, a composite rigid material.

[00133]Returning to FIG. 1A, housing 110 comprises a two-piece housing 110 and a housing seal 114 (not shown) disposed between said two pieces. The housing seal may be comprised of a polymer such as a rubber.

[00134] Although not shown, housing 10 comprises an input seal 116, in the form of an O-ring, for input 102.

[00135] Advantageously, device 100 may also detect heart rate and/or respiration rate. The heart rate may be detected with the two or more ECG cables 104. The respiration rate detection may be by impedance pneumography.

[00136] The auscultation data and ECG data may be synchronized such as, by time stamping to a single reference clock or multiplexing. The internal clock may be comprised on device 100 or computing network or system 200. The timing may comprise timing the start and finish of the sound or acoustic waves. The detected sound or acoustic waves may be recorded with a timestamp. The timestamp may be at regular time intervals. The timestamp may be referenced to the internal clock.

[00137] Two, three, or four ECG cables 104 may be connected to device 100. The cables 104 may bifurcate, or split to a higher order such that, up to seven lead ECG may be accommodated by device 100.

[00138] From the teaching herein, it is apparent that housing 110 is configured so that it is manoeuvrable by hand from one position to another position on a subject while the ECG cables remain attached to the subject's body.

[00139] The noise subtracted or cancelled may be noise generated within the auscultation device 100 such as by internal air and/or the auscultation device itself.

[00140] The noise or acoustic waves may be processed. The processing may comprise one or more of active and passive noise cancellation. The processing may comprise one or more filter. The one or more filter may comprise a high pass filter and/or a low passfilter.

[00141] Also provided is a first auscultation method comprising detecting sound or acoustic waves with one or more microphone 130, 140 disposed inside cavity 112. This first method also comprises receiving an auscultation input comprising the detected sound or acoustic waves from the one or more microphone 130, 140 and receiving an ECG input comprising received distal ECG signals, the ECG signals provided as detected ECG signals obtained from two or more ECG electrodes 106 connected to respective two or more electrocardiography (ECG) cables 104 received in an input 102.

[00142]Further provided is a first auscultation system for detecting sound or acoustic waves, comprising housing 110 defining cavity 112 and one or more microphone 130, 140 disposed inside cavity 112. The first auscultation system also provides input 102 for receiving two or more electrocardiography (ECG) cables 104, each of the two or more ECG cables 104 disposed to provide detected ECG signals obtained from two or more ECG electrodes 106 and a processor 205 for receiving an auscultation input comprising the detected sound or acoustic waves from the one or more microphone 130, 140 and an ECG input comprising the received distal ECG signals.

[00143] Additionally provided is a second auscultation method comprising directing sound or acoustic waves to a microphone 130 with an acoustic concentrator 150. The second auscultation method also comprises detecting the sound or acoustic waves with the microphone 130.

[00144] Also provided is a second auscultation system for detecting sound or acoustic waves comprising a microphone 130 for detecting sound or acoustic waves. The second auscultation system also comprises an acoustic concentrator 150 for directing sound or acoustic waves to the microphone 130 and a grommet 180.

[00145] Additionally provided is a third auscultation method comprising directing sound or acoustic waves to a primary microphone 130 with acoustic concentrator 150 and capturing ambient sound with primary microphone 130 and directing sound or acoustic waves to secondary microphone 140 with grommet 180. This third method also comprises capturing noise with secondary microphone 140.

[00146]Further provided is a third auscultation system for detecting sound or acoustic waves comprising an acoustic concentrator 150 for directing sound or acoustic waves to a primary microphone 130, a grommet 180 for directing sound or acoustic waves to a secondary microphone 140 for capturing noise.

[00147] The device 100, methods and systems may further comprise one or more sensors. The one or more sensors may comprise one or more optical sensors; one or more gyroscopes; one or more near-infrared spectroscopy (NIRS) sensors; one or more transmission photoplethysmography sensors; one or more magnetometer and/or or one or more accelerometers. Data from the one or more sensors may be correlated with the detected sound or acoustic waves. The one or more NIRS sensors may be used to assess levels of tissue oxygenation and/or cerebral blood flow. Each respective sensor of the one or more sensors may be connected by one or more wire or wirelessly to device 100.

[00148] The sound or acoustic waves may comprise one or more internal bodily sound. The internal body sound may comprise one or more of a circulatory system sound; a respiratory system sound; and/or a gastrointestinal sound. The circulatory system sound may comprise cardiac sound. The cardiac sound may comprise at least one of heart valve sound and/or coronary artery sound. The internal bodily sound, circulatory system sound a respiratory system sound and a gastrointestinal sound may comprise a normal or typical sound and/or a disease or condition sound. The coronary artery sound may comprise a normal or typical coronary artery sound such as normal blood flow. The coronary artery sound may comprise a coronary artery disease or condition sound such as, turbulent blood flow.

[00149] From the teaching herein, the skilled person understand that a turbulent flow in the coronary arteries is indicative of coronary artery disease (CAD), also known as ischemic heart disease (IHD).

[00150] The circulatory system sound may comprise one or more of a heart beat sound and a blood flow sound. The heart beat sound may comprise a normal or typical heart sound such as, one or more valve closing sound. The one or more valve closing sound may comprise the first heart sound and/or the second heart sound. The heart beat sound may also comprise a cardiovascular disease or condition sound such as one or more of the third heart sound; the fourth heart sound; one or more click; and/or one or more rub.

[00151] The respiratory system sound may comprise one or more of a larynx or laryngeal sound; a tracheal sound; and a bronchial sound.

[00152] The gastrointestinal sound may comprise a bowel sound.

[00153] The device 100 and/or computing device 201 may perform an analysis of the detected sound or acoustic waves and/or detected ECG signals and display a result. The displayed result may comprise a diagnostic result; a prognostic result and/or an indication of a disease or condition. The displayed result may comprise one or more of heart rate; heart rate variability; and respiration rate. The diagnostic result, prognostic result and/or indication may be provided for one or more of arrythmia; valvular heart disease (VHD); rheumatic heart disease (RHD); coronary artery disease (CAD); heart failure and/or cardiomyopathy.

[00154] The device 100 and/or computing device 201 may communicate with one or more Electronic Medical Record (EMR) and/or Electronic Health Record (EHR) platforms.

[00155] The device 100 and/or computing device 201 may comprise a display to present a graphical user interface (GUI). The GUI may receive and issue commends for performing desired operations.

[00156] The subject may comprise a human or non-human animal. The non-human animal may comprise a companion animal; a livestock animal; a performance animal; and/or a zoological animal. The performance animal may comprise a racehorse or a greyhound. The zoological animal may comprise an animal housed at a zoo.

[00157] The data from the one or more microphone 130, 140 and two or more ECG cable 104 may be recorded in a device internal memory such as, memory 206 (see FIGS. 2A and

2B and description below) for subsequent transfer to a companion device such as, personal computing device 201. As shown in FIGS. 2A and 2B, from personal computing device 201, the recorded biosignals may be sent to or accessed, through network 220 by another computing device within computer system 200.

[00158]Internal memory 206 and storage devices, such as those described with reference to FIGS. 2A and 2B, may be used for recording and storing the detected biosignals. The detected biosignals from microphones 130, 140 and cables 104 may be recorded and stored in a multichannel file wherein each channel may correspond to each respective sensor.

[00159] Device 100 may further comprise a transmitter or transceiver 216 for communicating the detected biosignals through to network 220. The transmitter or transceiver 216 may communicate wirelessly.

[00160] Although not shown, device 100 may further comprise sound insulating material.

[00161] The device 100, method and system of the invention may utilise ballistocardiography.

[00162] One embodiment of a computer network or system 200 suitable for use in the present invention is shown in FIGS. 2A and 2B. In the embodiment shown computer system 200 comprises a personal computing device 201, which may be comprised in device 100, comprising input devices such as a keyboard 202, a mouse pointer device 203, a scanner 226, an external hard drive 227, and a microphone 280; and output devices including a printer 215, a display 214 and loudspeakers 217. In some embodiments display 214 may comprise a touchscreen.

[00163] A Modulator-Demodulator (Modem) transceiver device 216 may be used by the computing device 201 for communicating to and from a communications network 220 via a connection 221. The network 220 may be a wide-area network (WAN), such as the Internet, a cellular telecommunications network, or a private WAN. Through the network 220, computing device 201 may be connected to other similar computing device 290 or server computers 291. Where the connection 221 is a telephone line, the modem 216 may be a traditional "dial-up" modem. Alternatively, where the connection 221 is a high capacity (e.g.: cable) connection, the modem 216 may be a broadband modem. A wireless modem may also be used for wireless connection to network 220.

[00164] The computing device 201 typically includes at least one processor 205, and a memory 206 for example formed from semiconductor random access memory (RAM) and semiconductor read only memory (ROM). The computing device 201 also includes a number of input/output (I/O) interfaces including: an audio-video interface 207 that couples to the video display 214, loudspeakers 217 and microphone 280; an I/O interface 213 for the keyboard 202, mouse 203, scanner 226 and external hard drive 227; and an interface 208 for the external modem 216 and printer 215. In some implementations, modem 216 may be incorporated within the computing device 201, for example within the interface 208. The computing device 201 also has a local network interface 211 which, via a connection 223, permits coupling of the computing device 201 to a local computer network 222, known as a Local Area Network (LAN).

[00165] As also illustrated, the local network 222 may also couple to the wide network 220 via a connection 224, which would typically include a so-called "firewall" device or device of similar functionality. The interface 211 may be formed by an Ethernet circuit card, a Bluetooth wireless arrangement or an IEEE 802.11 wireless arrangement or other suitable interface.

[00166] The I/O interfaces 208 and 213 may afford either or both of serial and parallel connectivity, the former typically being implemented according to the Universal Serial Bus (USB) standards and having corresponding USB connectors (not illustrated).

[00167] Storage devices 209 are provided and typically include a hard disk drive (HDD) 210. Other storage devices such as, an external HD 227, a disk drive (not shown) and a magnetic tape drive (not shown) may also be used. An optical disk drive 212 is typically provided to act as a non-volatile source of data. Portable memory devices, such as optical disks (e.g.: CD-ROM, DVD, Blu-Ray Disc), USB-RAM, external hard drives and floppy disks for example, may be used as appropriate sources of data to the computing device 201. Another source of data to computing device 201 is provided by the at least one server computer 291 through network 220.

[00168] The components 205 to 213 of the computing device 201 typically communicate via an interconnected bus 204 in a manner that results in a conventional mode of operation of computing device 201. In the embodiment shown in FIGS. 2A and 2B, processor 205 is coupled to system bus 204 through connections 218. Similarly, memory 206 and optical disk drive 212 are coupled to the system bus 204 by connections 219. Examples of computing device 201 on which the described arrangements can be practiced include IBM PC's and compatibles, Sun Sparc stations, Apple computers; smart phones; tablet computers; smart watches or like a device comprising a computing device like computing device 201. It is to be understood that when computing device 201 comprises a smart phone; smart watch or a tablet computer, display device 214 may comprise a touchscreen and other input and output devices may not be included such as, mouse pointer device 203; keyboard 202; scanner 226; and printer 215.

[00169]FIG. 2B is a detailed schematic block diagram of processor 205 and a memory 234. The memory 234 represents a logical aggregation of all the memory modules, including the storage device 209 and semiconductor memory 206, which can be accessed by the computing device 201 in FIG. 2A.

[00170] The methods of the invention may be implemented using computing device 201 wherein the methods may be implemented as one or more software application programs 233 executable within computing device 201. In particular, the steps of the methods of the invention may be effected by instructions 231 in the software carried out within the computing device 201

[00171] The software instructions 231 may be formed as one or more code modules, each for performing one or more particular tasks. The software 233 may also be divided into two separate parts, in which a first part and the corresponding code modules performs the method of the invention and a second part and the corresponding code modules manage a graphical user interface between the first part and the user.

[00172] The software 233 may be stored in a computer readable medium, including in a storage device of a type described herein. The software is loaded into the computing device 201 from the computer readable medium or through network 221 or 223, and then executed by computing device 201. In one example the software 233 is stored on storage medium 225 that is read by optical disk drive 212. Software 233 is typically stored in the HDD 210 or the memory 206.

[00173] A computer readable medium having such software 233 or computer program recorded on it is a computer program product. The use of the computer program product in the computing device 201 preferably effects a device or apparatus for implementing the methods of the invention.

[00174] In some instances, the software application programs 233 may be supplied to the user encoded on one or more disk storage medium 225 such as a CD-ROM, DVD or Blu Ray disc, and read via the corresponding drive 212, or alternatively may be read by the user from the networks 220 or 222. Still further, the software can also be loaded into the computing device 201 from other computer readable media. Computer readable storage media refers to any non-transitory tangible storage medium that provides recorded instructions and/or data to the computing device 201 or computer network 200 for execution and/or processing. Examples of such storage media include floppy disks, magnetic tape, CD-ROM, DVD, Blu-ray Disc, a hard disk drive, a ROM or integrated circuit, USB memory, a magneto-optical disk, or a computer readable card such as a PCMCIA card and the like, whether or not such devices are internal or external of the computing device 201. Examples of transitory or non-tangible computer readable transmission media that may also participate in the provision of software application programs 233, instructions 231 and/or data to the computing device 201 include radio or infra-red transmission channels as well as a network connection 221, 223, 334, to another computer or networked device 290, 291 and the Internet or an Intranet including email transmissions and information recorded on Websites and the like.

[00175] The second part of the application programs 233 and the corresponding code modules mentioned above may be executed to implement one or more graphical user interfaces (GUIs) to be rendered or otherwise represented upon display 214. Through manipulation of, typically, keyboard 202, mouse 203 and/or screen 214 when comprising a touchscreen, a user of computing device 201 and the methods of the invention may manipulate the interface in a functionally adaptable manner to provide controlling commands and/or input to the applications associated with the GUI(s). Other forms of functionally adaptable user interfaces may also be implemented, such as an audio interface utilizing speech prompts output via loudspeakers 217 and user voice commands input via microphone 280. The manipulations including mouse clicks, screen touches, speech prompts and/or user voice commands may be transmitted via network 220 or 222.

[00176] When the computing device 201 is initially powered up, a power-on self-test (POST) program 250 may execute. The POST program 250 is typically stored in a ROM 249 of the semiconductor memory 206. A hardware device such as the ROM 249 is sometimes referred to as firmware. The POST program 250 examines hardware within the computing device 201 to ensure proper functioning, and typically checks processor 205, memory 234 (209, 206), and a basic input-output systems software (BIOS) module 251, also typically stored in ROM 249, for correct operation. Once the POST program 250 has run successfully, BIOS 251 activates hard disk drive 210. Activation of hard disk drive 210 causes a bootstrap loader program 252 that is resident on hard disk drive 210 to execute via processor 205. This loads an operating system 253 into RAM memory 206 upon which operating system 253 commences operation. Operating system 253 is a system level application, executable by processor 205, to fulfil various high level functions, including processor management, memory management, device management, storage management, software application interface, and generic user interface.

[00177] Operating system 253 manages memory 234 (209, 206) in order to ensure that each process or application running on computing device 201 has sufficient memory in which to execute without colliding with memory allocated to another process. Furthermore, the different types of memory available in the computing device 201 and computer network 200 must be used properly so that each process can run effectively. Accordingly, the aggregated memory 234 is not intended to illustrate how particular segments of memory are allocated, but rather to provide a general view of the memory accessible by computing device 201 and how such is used.

[00178]Processor 205 includes a number of functional modules including a control unit 239, an arithmetic logic unit (ALU) 240, and a local or internal memory 248, sometimes called a cache memory. The cache memory 248 typically includes a number of storage registers 244, 245, 246 in a register section storing data 247. One or more internal busses 241 functionally interconnect these functional modules. The processor 205 typically also has one or more interfaces 242 for communicating with external devices via the system bus 204, using a connection 218. The memory 234 is connected to the bus 204 by connection 219.

[00179] Application program 233 includes a sequence of instructions 231 that may include conditional branch and loop instructions. Program 233 may also include data 232 which is used in execution of the program 233. The instructions 231 and the data 232 are stored in memory locations 228, 229, 230 and 235, 236, 237, respectively. Depending upon the relative size of the instructions 231 and the memory locations 228-230, a particular instruction may be stored in a single memory location as depicted by the instruction shown in the memory location 230. Alternately, an instruction may be segmented into a number of parts each of which is stored in a separate memory location, as depicted by the instruction segments shown in the memory locations 228 and 229.

[00180]In general, processor 205 is given a set of instructions 243 which are executed therein. The processor 205 then waits for a subsequent input, to which processor 205 reacts by executing another set of instructions. Each input may be provided from one or more of a number of sources, including data generated by one or more of the input devices 202, 203, or 214 when comprising a touchscreen, data received from an external source across one of the networks 220, 222, data retrieved from one of the storage devices 206, 209 or data retrieved from a storage medium 225 inserted into the corresponding reader 212. The execution of a set of the instructions may in some cases result in output of data. Execution may also involve storing data or variables to the memory 234.

[00181] The disclosed arrangements use input variables 254 that are stored in the memory 234 in corresponding memory locations 255, 256, 257, 258. The described arrangements produce output variables 261 that are stored in the memory 234 in corresponding memory locations 262, 263, 264, 265. Intermediate variables 268 may be stored in memory locations 259, 260, 266 and 267.

[00182] The register section 244, 245, 246, the arithmetic logic unit (ALU) 240, and the control unit 239 of the processor 205 work together to perform sequences of micro operations needed to perform "fetch, decode, and execute" cycles for every instruction in the instruction set making up the program 233. Each fetch, decode, and execute cycle comprises: (a) a fetch operation, which fetches or reads an instruction 231 from memory location 228, 229, 230; (b) a decode operation in which control unit 239 determines which instruction has been fetched; and (c) an execute operation in which the control unit 239 and/or the ALU 240 execute the instruction.

[00183] Thereafter, a further fetch, decode, and execute cycle for the next instruction may be executed. Similarly, a store cycle may be performed by which the control unit 239 stores or writes a value to a memory location 232.

[00184] Each step or sub-process in the methods of the invention may be associated with one or more segments of the program 233, and may be performed by register section 244 246, the ALU 240, and the control unit 239 in the processor 205 working together to perform the fetch, decode, and execute cycles for every instruction in the instruction set for the noted segments of program 233.

[00185] One or more other computers 290 may be connected to the communications network 220 as seen in FIG. 2A. Each such computer 290 may have a similar configuration to the computing device 201 and corresponding peripherals.

[00186] One or more other server computer 291 may be connected to the communications network 220. These server computers 291 response to requests from the personal device or other server computers to provide information.

[00187] The method of the invention may alternatively be implemented in dedicated hardware such as one or more integrated circuits performing the functions or sub functions of the described methods. Such dedicated hardware may include graphic processors, digital signal processors, or one or more microprocessors and associated memories.

[00188]It will be understood that in order to practice the methods of the invention as described above, it is not necessary that the processors and/or the memories of the processing machine be physically located in the same geographical place. That is, each of the processors and the memories used in the invention may be located in geographically distinct locations and connected so as to communicate in any suitable manner. Additionally, it will be understood that each of the processor and/or the memory may be composed of different physical pieces of equipment. Accordingly, it is not necessary that a processor be one single piece of equipment in one location and that the memory be another single piece of equipment in another location. That is, it is contemplated that the processor may be two pieces of equipment in two different physical locations. The two distinct pieces of equipment may be connected in any suitable manner. Additionally, the memory may include two or more portions of memory in two or more physical locations.

[00189] To explain further, processing as described above is performed by various components and various memories. It will be understood, however, that the processing performed by two distinct components as described above may, in accordance with a further embodiment of the invention be performed by a single component. Further, the processing performed by one distinct component as described above may be performed by two distinct components. In a similar manner, the memory storage performed by two distinct memory portions as described above may, in accordance with a further embodiment of the invention, be performed by a single memory portion. Further, the memory storage performed by one distinct memory portion as described above may be performed by two memory portions.

[00190] Further, various technologies may be used to provide communication between the various processors and/or memories, as well as to allow the processors and/or the memories of the invention to communicate with any other entity, i.e., so as to obtain further instructions or to access and use remote memory stores, for example. Such technologies used to provide such communication might include a network, the Internet, Intranet, Extranet, LAN, an Ethernet, a telecommunications network (e.g., a cellular or wireless network) or any client server system that provides communication, for example. Such communications technologies may use any suitable protocol such as TCP/IP, UDP, or OSI, for example.

Claims

CLAIMS The claims defining the invention are as follows:

1. An auscultation device comprising: a housing defining one or more cavity; one or more microphone disposed inside the one or more cavity, each of the one or more microphone detecting sound or acoustic waves; an acoustic concentrator comprising a mouth and a neck, the acoustic concentrator disposed on an auscultation side of the housing to direct sound or acoustic waves to the one or more microphone; a diaphragm spanning the mouth of the acoustic concentrator; an input disposed on or in the housing, the input for receiving one or more electrocardiography (ECG) cables, each of the one or more ECG cables disposed to provide detected ECG signals obtained from one or more ECG electrode; and a processor for receiving an auscultation input comprising the detected sound or acoustic waves from the one or more microphone and an ECG input comprising the received ECG signals.

2. An auscultation method comprising: detecting sound or acoustic waves with one or more microphone disposed inside a cavity defined within a housing the detected sound or acoustic waves directed to the one or more microphone by an acoustic concentrator comprising a mouth and a neck disposed on an auscultation side of the housing and a diaphragm spanning the mouth of the acoustic concentrator; receiving an auscultation input comprising the detected sound or acoustic waves from the one or more microphone; and receiving an ECG input comprising received ECG signals, the ECG signals provided as detected ECG signals obtained from one or more ECG electrode connected to respective one or more electrocardiography (ECG) cables received in an input disposed on or in the housing.

3. An auscultation system for detecting sound or acoustic waves, the system comprising: a housing for defining a cavity; one or more microphone for detecting sound or acoustic waves, each of the one or more microphone disposed inside the cavity; an acoustic concentrator comprising a mouth and a neck, the acoustic concentrator disposed on an auscultation side of the housing to direct sound or acoustic waves to the one or more microphone; a diaphragm spanning the mouth of the acoustic concentrator; an input for receiving one or more electrocardiography (ECG) cables, the input disposed on or in the housing, each of the one or more ECG cables disposed to provide detected ECG signals obtained from one or more ECG electrode; and a processor for receiving an auscultation input comprising the detected sound or acoustic waves from the one or more microphone and an ECG input comprising the received distal ECG signals.

4. The device, method or system according to any one of claims 1 to 3 further comprising a grommet providing a hermetic seal.

5. The device, method or system according to claim 4 wherein the grommet comprises a primary chamber to secure the acoustic concentrator.

6. The device, method or system according to claim 4 or claim 5 wherein the grommet comprises a secondary chamber dimensioned to direct ambient sound to a secondary microphone.

7. The device, method or system according to claim 6 wherein the secondary chamber is dimensioned to direct ambient sound of a similar character recorded by a primary microphone as noise.

8. The device, method or system according to any one of claims 1 to 7 comprising a one-piece acoustic concentrator-diaphragm.

9. The device, method or system according to any one of claims 1 to 7 wherein the acoustic concentrator and diaphragm are comprised in an acoustic concentrator-diaphragm assembly.

10. The device, method or system according to any one of claims 1 to 7 and 8 wherein the grommet, acoustic concentrator and diaphragm are securely fastened together.

11. The device, method or system according to any one of claims 1 to 10 wherein the neck of the acoustic concentrator aligns with a primary microphone and/or a primary microphone feed channel.

12. The device, method or system according to any one of claims 1 to 11 wherein at least one of heart rate and/or respiration rate are detected.

13. The device, method or system according to claims any one of claims 1 to 12 wherein the auscultation data and ECG data are synchronized.

14. The device, method or system according to any one of claims 1 to 13 wherein multiple ECG cables are connected, or connectable, to the device.

15. The device, method or system according to any one of claims 1 to 14 wherein the housing is configured so that it is manoeuvrable by hand from one position to another position on a subject.

16. The device, method or system according to any one of claims 1 to 15 wherein ambient sound is subtracted from the detected sound or acoustic waves.

17. The device, method or system according to any one of claims 1 to 16 wherein the sound or acoustic waves comprise one or more bodily sound and ambient sound.

18. The device, method or system according to any one of claims 1 to 17 wherein the sound or acoustic waves comprise one or more internal bodily sound.

19. The device, method or system according to any one of claims 1 to 18 wherein an analysis of the detected sound or acoustic waves and/or detected ECG signals is performed and a result of the analysis displayed.

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