WO2012162740A1 - Système de surveillance électronique pour la production d'ensembles de données dans des buts d'analyse et de diagnostic - Google Patents

Système de surveillance électronique pour la production d'ensembles de données dans des buts d'analyse et de diagnostic Download PDF

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Publication number
WO2012162740A1
WO2012162740A1 PCT/AU2012/000606 AU2012000606W WO2012162740A1 WO 2012162740 A1 WO2012162740 A1 WO 2012162740A1 AU 2012000606 W AU2012000606 W AU 2012000606W WO 2012162740 A1 WO2012162740 A1 WO 2012162740A1
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WIPO (PCT)
Prior art keywords
data
patient
sleep
sound
sounds
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PCT/AU2012/000606
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English (en)
Inventor
Colin Edward Sullivan
Peter Charles Spencer
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Sonomedical Pty Ltd
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Priority claimed from AU2011902119A external-priority patent/AU2011902119A0/en
Application filed by Sonomedical Pty Ltd filed Critical Sonomedical Pty Ltd
Publication of WO2012162740A1 publication Critical patent/WO2012162740A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00—Instruments for auscultation
    • A61B7/02—Stethoscopes
    • A61B7/04—Electric stethoscopes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0004—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by the type of physiological signal transmitted
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B7/00—Instruments for auscultation
    • A61B7/003—Detecting lung or respiration noise
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H80/00—ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Definitions

  • the present invention relates to systems and methods associated with the acquisition, distribution and use of clinical data for diagnostic and other purposes.
  • the invention further relates lo a system in which data and information collected by sensing and monitoring apparatuses enables the preparation of a package of clinically relevant data for a particular patient condition for transfer lo relevant professionals, patients and carers enabling one or more of those individuals to apply that package of data for diagnostic or other medical and/or non medical purposes.
  • the invention also provides a system of distribution of collected data including data related to and perceptible by various senses such as. but not limited to. sound.
  • the invention further provides a data package transfer system which distributes patient related packages of data to enable provisional diagnosis or assessment of clinical significance and consideration of data including data which is relevant but not observed by practitioner.
  • the diagnosis of disease is made using a series of steps starting with the taking of a medical history, in which symptoms of disease are sought, followed by a physical examination in which clinical signs are detected. The symptoms and physical signs then determine the appropriate test procedures to be done (which may include for example, blood tests. X rays, electrocardiogram, CAT scans etc).
  • ⁇ patient's symptoms are obtained in several steps.
  • the patient volunteers the information in response to the general question - "what is / are the problems?" (i.e. "I have chest pain " ).
  • the medical examiner asks a series of well defined question that seek symptoms typical of a wide range of disease processes. These questions usually follow a systematic review of each organ system with set questions seeking symptoms of heart disease, lung disease, gut disease, neurological disease etc. Most symptoms cannot be verified by an external observer as they are the subjective experience of the patient. For example, patient complaints of chest pain, headache, breathlessness etc are symptoms impossible to measure by the external observer. Finding physical signs lhat link those symptoms to a disease process is the next step in tine process.
  • a clinician examines a patient to identify physical signs using uses his/her human visual, tactile, auditory, and olfactory senses to identify abnormalities.
  • visual inspection can reveal a range of signs such as cyanosis, jaundice, or the presence of abnormal movements, or gait etc.
  • Tactile examination may reveal the presence of localised pain, an enlarged body organ (e.g. liver or spleen), or the location of an abnormal mass (e.g. a breast lump, or an abdominal mass).
  • Olfactory signs may reveal the typical smell of liver failure, for example.
  • This sequence of evaluation is exemplified by way of an example; when a patient is found to complain of the symptom of breathlessness, finding the presence of wheezing on chest physical examination leads to the provisional diagnosis of asthma. In contrast, finding crackles on chest examination, points the physician in the direction of heart failure or lung infection. 10004]
  • One of the most important tools that a clinician uses to elicit physical signs is the stethoscope. This form of physical examination is called "auscultation”. The stethoscope amplifies various vibrations generated by the body (e.g. breathing, cardiac and gut. blood flow in vessels etc) so that an ordinary clinician can hear them.
  • the assessment is highly specific for pathology (for example, wheeze which indicates airways obstruction: or crackles (also called crepitations) in the lungs— indicating likely heart failure; or other sounds that indicate the presence of a heart murmur).
  • pathology for example, wheeze which indicates airways obstruction: or crackles (also called crepitations) in the lungs— indicating likely heart failure; or other sounds that indicate the presence of a heart murmur.
  • the combination of palpation and auscultation typically give highly specific information — for example palpation of the thorax will demonstrate a bruit (a course continuous vibration) combined with a continuous murmur on auscultation)— typical of a patent ductus arteriosus.
  • the occurrence of intestinal obstruction— for example as occurs in paralytic ileus— can be identified by the auscultation of a characteristic "tinkling" sound.
  • Palpation and auscultation are also used in assessing a Telus.
  • the fetus normally makes a large number of various movements, including breathing movements, lhat are best palpated ( as they are low frequency) as well as fetal heart sounds (which have higher frequency components that may be audible with some form of amplification).
  • other pregnancy related functions such as uterine and placental blood flow can be assessed with auscultation.
  • the eliciting of physical signs by means of a clinical physical examination still remains a cornerstone and
  • Lt IiiiuIo3 ⁇ 4j s Midi a > mydeui ultrasound can literally reveal the structural features and heart function of a fetus.
  • heart monitors can provide a continuous measure of fetal and fetal heart movements over hours and days.
  • Practitioners involved in diagnosis need proof in a form that it understandable to them that the disease is present before they will recommend treatment, and then alter diagnosis they need further proof that the treatment is actually working. Where serious disease signs are not directly evident and proven it is less likely thai each patient will have an optimal outcome. In general patients with a particular disease will not be identified and treated as someone with a serious health problem. Healthcare providers will be less likely to send patients for review or appropriate treatment to other healthcare providers if there is not sufficient evidence of disease and evidence flow between the relevant professionals. Patients and their carers will be less likely tn lake the presence and treatment of a disease seriously if they don't experience compelling evidence of its incidence and severity. Finally, in most health care systems, the organisation that pays for the disease management will require robust evidence of the disease and the outcomes of treatment before agreeing to reimburse the various practitioners / and or insured patient.
  • the general problem can be illustrated with an example of the suspicion, diagnosis and treatment of the sleep apnea syndrome.
  • General practitioners may identify a patient who reports snoring which disturbs a partner.
  • the GP may suspect the patient has sleep apnea and may send the patient to a sleep specialist who diagnoses the patient using polysomnography (PSG).
  • PSG polysomnography
  • the sleep physician will decide if the patient should receive positive airway pressure therapy, or an oral device.
  • the specialist may send the patient t a dentist for filling of a mandibular advancement splint (MAS) for instance if it is found that the patient snore3 without significant levels of sleep apnea.
  • MAS mandibular advancement splint
  • Diseases and signs include partial or total upper airway obstruction, central apnea, chronic obstructive pulmonary disease, asthma, o n ⁇ tAti vc lic ⁇ ut failure, cardiac and vas ular murmurs and Sons, bmxism ( leclh grinding), reflux and heart murmurs.
  • Electronic stethoscopes can be used to record sounds of interest for storage or playback following a consultation, to other clinicians who may not be present with the patient.
  • Electronic stethoscopes can also be used to facilitate telcmedicine enabling a clinician to consult in real time on a patient where they arc at a site remote from the patient.
  • these devices require a healthcare professional to be present with the patient in order to hold the stethoscope in place. Typically during this time the patient will also be awake.
  • Electronic stethoscopes can't be used on an unattended patient.
  • these sound files are typically used by one clinician to diagnose a patient and not to provide evidence of disease severity to all the non-diagnosing professionals in the treatment chain.
  • ⁇ disadvantage of the electronic stethoscope is that only the sound file and not the palpation related information can be recorded and replayed. Following diagnosis by one clinical professional he or she will typically communicate their findings to others including general practitioners, patients and carers through the use of a written or verbal diagnostic summary without provision of any disease si n evidence.
  • the diagnosing clinician can study the patient within a clinic where they are attended by sleep technicians during the night or through use of take home sleep study equipment for use in an unattended study, In both cases typically a clinician specializing in sleep medicine undertakes the diagnosis and is rarely attendant at the clinic during the study period.
  • the equipment used typically involves cither thermocouple (or thermistor) and / or pressure sensors placed in or near the palienf s nostrils to measure breathing flow. Neither of these sensors provides sound files.
  • a minority of devices also may include a room sound microphone, or microphone or accelerometer for attachment to the patient for recording breathing related sounds.
  • Video may also be used to provide visual and sound ic ⁇ -uidings of the study period. These records are typically assessed by the sleep technicians to provide quantitative written metrics of the potient'r. status. The s p physician will typically review the technicians report and may sample some of the record files including the microphone or video material if present and then make a diagnosis. The sleep physician will typically review their diagnosis with the patient verbally and send a written diagnostic summary to the patient's general practitioner, Although some method to record snoring is often used— Ihc only component of this recording that is reported is an overall statement of the presence or absence of snoring. The commonest method is to use an accelerometer to record only the low frequency component of snoring, a signal that is not suitable to provide a replay of the actual sound.
  • Sound files or palpation files indicative of the patient's condition such as snoring sounds or other sounds or vibrations related to partial or total obstruction are not provided as definitive evidence of the patient's condition to the patient, their carer, the patient's general practitioner or other healthcare professionals such as a dentist.
  • wheezing is a sound that is instantly recognized by clinicians, other relevant health professionals as well us patients and their carers.
  • sound sensors have been developed for use in diagnosing the presence and severity of asthma and cough particularly in young children who are unable to use other methods such as spirometry. Sensors have been developed for use when the clinician is present. These are held against the patient. Attachable sensors have been developed for use in unattended studies.
  • These devices may also be used by a patient or carer at home ' in order to communicate the status of the homebound or remote patient to the clinician.
  • the sound files generated by these devices are used for diagnosis of disease presence and severity.
  • a disadvantage of the aforesaid sensor devices, such hand held devices, can only be used for brief periods and are not suitable for long term measurement or obtaining measurements from a sleeping subject. They were not developed for providing evidence of disease presence and severity to practitioners not involved directly in the diagnostic process
  • the present invention provides a system in which data packages and clinical information are collected by suitable sensing and monitoring apparatuses.
  • the system enables the preparation of at least one package of clinically relevant data for a particular patient condition for transfer to relevant persons such as butnot limited to parents of children, health professionals, diagnostic professionals enabling one or more of those persons or professionals to apply targeted packages of data for diagnostic or other medical or non medical purposes.
  • the system also provides the package of information to enable and enhance remote case-conference meetings of all relevant carers, practitioners and specialist consultants to enable remote examination of the subject..
  • a system and method which can conveniently capture and provide the appropriate evidence for each data recipient including practitioners increases the likelihood with time that more patients can be identified, diagnosed and successfully treated.
  • Such a system needs to be convenient and able to be easily and safely set-up and used over long periods when only the patient is present and in cases where the patient may be sleeping or unconscious, and in the case of an elderly person or invalid cither in their own home or care facility
  • systems which require young children to be assessed overnight in hospital may also require that their parents stay in order to reduce the level of their child's anxiety. This is very disruptive and inconvenient for the family and reduces the likelihood that a child will undergo monitoring and review.
  • the severity of some diseases such as asthma is affected by the environment, so thai testing in the subject's normal environment is an important factor in gaining an accurate overview of disease status.
  • a system which can be used simply at home due to its convenience will increase the likelihood that parents and other stakeholders will undertake the monitoring assessment.
  • the package of data includes sounds and/or palpation signals from patients with breathing obstruction, snoring, asthma, bruxing, cardiac related and other signs of disorders and diseases.
  • the data may also include video records.
  • the data packages created by the sensing and monitoring apparatuses provide practitioners and patients alike with evidence of particular conditions which would not previously have been included in patient data due to the difficulty in establishing patient monitoring and measuring regimes.
  • An advantage of the system of data acquisition, transfer and application provided by present invention is that it increases ( medical and/or non medical) practitioner confidence in treatments based on additional data and evidence of pathologies not previously part of clinical observations and when used in conjunction with previously obtainable data such as partner observations. As a result a practitioner will have increased confidence in referral of patients for specialist review and treatment.
  • the present invention also allows a recipient of the data packages to employ data so that touch can be used to contribute to assessment and diagnosis. More specifically in the case of palpation or vibrational information a disease indication can be determined by touching or feeling sound data through a speaker cone or
  • i f vibrating touch pad which is related lt> a particular patient.
  • One example bf a condition indication which can be obtained using this method is a bruit.
  • a system which provides clinical patient dala to medical and non medical practitioners and patients and their carers to enable detection and treatment of a patient pathology determined from the data; the system including,
  • an apparatus comprising at least a sensor capable of sensing data from the patient and/or a video recording device; the at least one sensor and video recording device enabling over a predetermined period of time, detection and storage of at least one package of data including patient parameters, ambient local sound, ausculatory sound. and/or video recordings relating to a pathology of the patient;
  • Authorisation or eligibility criteria for use of the data packages includes but i$ not limited to payment for each data package, registration lor use, entry into a License for use.
  • the present invention comprises: an apparatus which over a predetermined period of time, detects and stores at least one package of data including patient parameters, ambient local sound, auscultatory sound, palpably detectable vibration, and/or video recordings relating to a pathology of the patient;
  • At least part of the data package is playable on a device which allows visual t id ⁇ auibitnt loeol sound and/or auccultntoiy cound signals or images of patient parameters to be used by the practitioner.
  • the sound data is readable by touch and feel of vibrations in a sound emitting speaker or other surface such as a model of human thorax, abdomen etc.
  • the present invention provides a system integrated with a medical diagnostic and record playing apparatus in which the apparatus includes sensors, readers, monitors, video recorders to allow continuous sensing and recording of patient sounds and/ or palpably detectable signals, video signals and/or olfactory signals to indicate the presence of disease or a condition including various respiratory, cardiae, gastrointestinal, dental and other disorders or diseases.
  • sensors of a direct contact and/or remote ( contactless) sensing type in which sensors are either attached to the patient or remotely located relative to a patient such that when sensors are not attached, the patient can freely move in relationship to the sensors.
  • microphones and or remote sensors can be used to monitor and record patient data.
  • the data is collected from patients who arc unattended by health professionals and the records can be obtained over selected time periods which may be many hours, days or weeks, according to the particular patient condition being evaluated. Patients may be asleep or unconscious. Alternatively they may be conscious and unattended, or invalid or elderly requiring constant supervision.
  • the data records are either manually or automatically analysed for signs indicating the presence and severity of disorders or diseases, and may be evaluated in relation to long time series (i.e. the chronobiological liming and pattern of the physical signs can be identified).
  • local ambient sound, auscultatory sound, palpable vibration data and video records arc playable by an authorised practitioner or practitioners or patient or their carer on suitable players which enable the practitioner to listen to sound, and feel vibrations created by sounds on speakers (or other surfaces) and see the related images either separately or concurrently on one apparatus or separately on dedicated separate players.
  • Data such as ambient localsound. ausculatory sound, palpable vibration, video and olfactory data are provided as a package available to one or more practitioners using separate reproduction apparatuses. Individual practitioners involved in the care of the patient or. multiple practitioners may review the records using the same apparatus.
  • the "package " of — ambient local sound, ausculaiory sound, palpable vibration data and time synchronised video — is available to enable all participants joining a case conference from remote locations to simultaneously undertake a physical examination of the patient, providing an efficient sharing of information to provide an efficient management outcome.
  • the system allows data records that consist of a "data package” (a “physical signs data package ”) that include sounds (both ambient local and proximate to the patient and auscultatory) and palpable vibrations, video images and /or olfactory signals that indicate the presence of absence of or incidence and or severity of a specific disorder or disease to be transmiued to groups or individuals involved in the treatment diagnosis of a particular patient.
  • a data package a "physical signs data package ”
  • sounds both ambient local and proximate to the patient and auscultatory
  • palpable vibrations video images and /or olfactory signals that indicate the presence of absence of or incidence and or severity of a specific disorder or disease to be transmiued to groups or individuals involved in the treatment diagnosis of a particular patient.
  • Practitioners who can receive and assess and analyse the data include; a patient carer (such as a parent of a child), the patient's general practitioner, non- diagnosing clinical specialists, and other healthcare practitioners such as dentists or nursing staff. ⁇ patient can also receive the patient data.
  • the packages of data allow the practitioner or patient to hear the records sound, feel the palpation signals, watch video images or smell the olfactory records using appropriate apparatus such as speakers or earphones for the sounds and by touching appropriate speaker components or vibrating surfaces for the palpation records or video players or computer monitors for the video files.
  • Chemica! emitting apparatus can be used for olfactory data records.
  • a data package therefore can contain tailored data drawn from combinations of the above parameters incJ ding video, sound and data capable of analysis by touching a device which is capable of vi bration.
  • control or comparative data can be provided from a library of sounds, palpation, video image signal records or olfactory records. These records can be drawn from patients' earlier records or from a data reference package to enable a practitioner to assess a patient's data relative to the reference package. In each case the reference package can be accompanied with written explanations and a guide to interpretation.
  • This approach can also be used for parent monitoring lo educate a parent as to normal and abnormal data. For instance, a parent may not be familiar with the sound of normal or abnormal snoring or significant upper airway breathing resistance in a young infant, or the difference in sound between a mild, moderate or severe asthmatic wheeze breathe sound. Library sounds and vibrations can be used to highlight differences in this data, l ' or both the practitioner and parent, the reference package allows a better understanding of the actual measured data package and will result in more accurate diagnosis and treatments. This results in higher patient compliance with treatment, increased confidence in diagnosis for the practitioner and increased GP confidence in specialist treatment, disease screening, diagnosis, treatment and review.
  • the availability of data and the creation of a data package provided by the system described herein increase the likelihood that diseases are identified earlier than previously without use of the system. Recorded information and data packages may be provided as files sent via the internet or using other methods to provide them to each user.
  • the ambient local sound, ausculatory sound, vibrations or video signals or olfactory signals and data referred to above may be simultaneously captured with one or more of a multiplicity f other records from other known sensor types including but not limited to oximeters.
  • a sleep specialist conducts a sleep study on a subject where the study includes the recordin - of an ECG signal as well as breathing and heart auscultatory sounds and heart related palpation records.
  • the subject is diagnosed as having sleep apnoea and the sleep physician also notes signs of atrial fibrillation or other cardiac abnormalities identified from listening to the heart sound signal or studying the F.CG signal.
  • the sleep physician sends sample "physical signs data package " ' of the subject's obstructed breathing to the subject as well as sound flics of their atrial fibrillation or other heart abnormalities and normal heart rhythm sounds.
  • the sleep physician includes a sleep apnoea diagnosis with the records and then relics on the cardiologist to diagnose the subjects cardiac abnormalities from the data package including heart sounds and for ECG and palpation records as well as undertaking any farther studies required.
  • the package of data for a particular patient could potentially include some or all available data drawn from various monitoring and detection apparatuses but a particular practitioner may only use that component of the data referable to one particular area of expertise, although taking into account the overall clinical picture of a patient.
  • the cardtologise for instance, will be likely to use vibrational records related to heart abnormalities.
  • the data packages are prescriptive and predictive. They are prescriptive in that a set of parameters to be measured can be prescribed in advance for the purpose of analysing for a suspected condition. Alternatively, the data packages are predictive in that a complete subject profile can be measured to provide a series of data packages having various sets of parameters from which selections can be made for study.
  • a respiratory specialist or general practitioner may use the data packages provided by the system of the present invention to study a child suspected of having nocturnal asthma at night in bed at its home. On review of the records the specialist or OP can diagnose nocturnal asthma as well as noticing signs pointing to the presence of sleep apnea. After the study analysis, auscultatory sound records of asthma and apnea events can be sent to the child's parents and also to a sleep specialist for review of the suspected apnea. The sleep specialist can identify the presence of snoring or apnea and could require further studies to complete a diagnosis of severity.
  • the sleep specialist using a data package will be able to hear the obvious signs ⁇ nocturnal asthma and potentially its time relationship to apneic events which may be causally related. This data would then be sent to the Respiratory (Asthma) specialist to convince him/her that the child does have asthma as well as • snoring and apnea.
  • the treatment for apnea may involve need for a tonsillectomy in which case sound files from a patient data package ("physical signs package”) can also be provided to an ear nose and throat surgeon in order to assess the need fo surgery.
  • a follow-up study can be completed and both specialists and the surgeon can review the tailored data package sound records to assess the effectiveness of treatment.
  • the parents are made aware of the signs and severity of the asthma and apnea through review of the sound files in the data package.
  • the parents ma also be involved in the treatment process through cleaning the child's room of potential allergens if they are affecting asthma severity and then help them provide a more judicious and timely use or asthma drugs.
  • the provision of the sound data iilcs informs all relevant practitioners about disease severity, the urgency of the required treatment and the ability to easily understand and monitor the success of treatment or of cleaning the child's environment for both diseases. It therefore facilitates understanding, urgency for action and increases the likelihood that the clinicians involved will optimise the identification, diagnosis and treatment of similar patients in the future.
  • Dam packages are presented with content to suit particular subjects and lor particular practitioners depending upon clinical objectives.
  • a package or packages of data can be provided for detection of a pathology of a subject such as asthma or congestive heart failure or cystic fibrosis or obstructive pulmonary disease (COPD”) potentially obtained with reference to a subject ' s sleep patterns.
  • COPD obstructive pulmonary disease
  • the reporting format for each medical or non medical practitioner and patient is according to one embodiment, in the form of written flics, record signal trace files and sound files, touch files for feeling vibration related signs or video or olfactory signs or any combination of these file types as appropriate for understanding by the reviewer.
  • Apparatus including software is designed to enable the simple identification, sampling and storage of relevant data records for presentation as part of a data package.
  • Files of library signs exemplifying disorder or disease information may also be provided to stakeholders in order to further optimise understanding of the test record files.
  • One advantage of the system of the present invention is that some or all non diagnosing practitioners or non practitioners can experience the physical signs using their own senses including tactile and or auditory or visual or olfactory systems.
  • a parent of a child can look and/or, hear and/or touch first hand a reproduced package of data referable to a state of behaviour such as occurs during the sleep cycle, breathing sounds, sound intensity generated by movement and breathing, heartbeat sounds, wheezing coughing and other behaviours.
  • a further advantage is that in circumstances where patients have multiple disorders or diseases and require the involvement of multiple specialists (eg subjects with diabetes and sleep apnea, sleep apnea, heart diseases and heart failure or sleep apnea and chronic lung disease and sleep apnea and asthma), the availability of tailored or targeted packages of data enables efficient integration and sharing of information from a patient oriented data package from which various practitioners can draw data appropriate to their specialty and review other potentially relevant data not directly related to that specialty. Due to the integration of the data packages practitioners can collectively assess a subject related to each practitioners field of expertise, all of which can be effected remotely as if the patient was physically present before each practitioner effectively allowing a simulated physical examination of each subject lor known or unknown conditions..
  • the data packages made up of data such as sounds generated by a variety of patient sources ( breathing, heartbeat etc), images, olfactory information, can be used in totality or broken up into specific sample record files or groups of files depending upon the information required on or for a particular patient and by a particular practitioner or group of practitioners.
  • the data package can be transmitted by any form of data carrying device such as but not limited to via the internet, emails, discs or portable drives.
  • Snoring is a loud, vibratory, annoying breathing sound made by someone sleeping. Despite this common problem, its medical significance and potential impact are very poorly understood by most. Snoring is typically regarded as a symptom. Thus, a patient will report to the clinician that he/she snores— and typically that the reason he/she knows about it is that a bed partner or someone who has been near the subject when they are asleep has told them about the noise. Snoring however, is a robust and characteristic physical sign of upper airway obstruction. It is not normally considered a physical sign because the clinician is not present when it is happening. It usually comes to light from a partner complaint.
  • a trained medical observer was present while the patient was asleep, he/she would identi y the snoring as a physical sign. Because the sounds that are produced during snoring have "signature" characteristics, most untrained listeners can readily recognize mild snoring from snoring that is on the verge of choking, and then a period of apnea. Snoring is particularly obvious sign that can be heard and felt by partners, parents and practitioners. Further, the sound quality ⁇ the snoring can clearly separate extremely obstructed breathing- with almost no air flowing into the lungs - from less severe mild vibratory snoring in which there is otherwise good air flow.
  • Example (1) Pediatric Subject with Asthma and Sleep Disordered Breathing-
  • CSD sleep disordered breathing
  • SDB sleep disordered breathing
  • enlarged tonsils and adenoids Nocturnal asthma is causing increased SDB severity.
  • the subject presents to the general practitioner with symptoms of mild daytime wheezing and sleepiness.
  • the OP sends the subject to the Asthma Specialist who suspects presence of nocturnal allergy related asthma.
  • An overnight study is ordered.
  • the Asthma Specialist diagnoses the presence and severity of Asthma and notes indications of sleep disordered breathing and enlarged tonsils and adenoids. They prescribe asthma treatment and also send the subject to the Sleep Specialist for review of potential sleep disordered breathing.
  • the Sleep Specialist diagnoses SDB and the enlarged tonsils, sending the subject to the Ear Nose and Throat Specialist (ENT) for review and possible tonsillectomy.
  • the ENT reviews the subject and completes a tonsillectomy. Following surgery a follow-up overnight study is completed and records sent to all parties to assess Asthma and SDB efficacy.
  • This specialist receives a package containing full night. sound records of all periods of wheezing and non-wheezing breathing sounds. Samples indicating examples of SDB such as snoring or apneas (breathing cessation) are included and highlighted. Samples of breath sound records showing the temporal relationship between wheezing and apnea would also be included. After tonsillectomy they receive the same data package from the follow-up study. Sleep Specialist: This specialist receives a data package containing the full nights sound (SBD and non SBD breath sounds) and body movement records indication all periods where SDB is present or ⁇ -b>cal. Seuijili-s of w ee ing sound records showing the temporal relationship between wheezing and apnea would also be included. After tonsillectomy they receive the same data package from the tbllow-up study.
  • Clinical Vignette A 55 year old overweight male with a prior history of myocardial infarct reports waking during tbe early morning with breathlcssncss. He has had a prior diagnosis of mild sleep apnea and is using an MAS ( Mandibular advancement device). The general practitioner refers the patient back to his cardiologist and also to his sleep physician. An overnight study is arranged and the study reveals snoring and sleep apnea despite the use of his oral device ( MAS), and in addition during the night there is a change in pattern from obstructive to central apnea with the development of crackles and the onset of a loud mitral murmur (that was not present during the day).
  • MAS Mandibular advancement device
  • Sleep Specialist TliiJ specialist receive! a data package containing thr. full nights sound (SBD and non SBD breath sounds) and body movement records indicating all periods where SDB is present or absent.
  • the package would also include samples of lung crackles and heart murmur sound records showing their temporal relationship with apnea. After CPAP and diuretic implementation they receive the same data package from a follow-up study to enable review of treatment efficacy.
  • Cardiology Specialist This specialist receives a full nights sound record of all the periods involving crackle and heart murmur sounds as well as periods where the.se sounds are absent The specialist also receives sample sound records of SDB sounds indicating snoring or apnea. After CPAP and diuretic treatment they receive the same data package from a Ibl low-up study.
  • Sleep Specialist This specialist receives a data package containing the full nights sound (SBD and non SBD breath sounds) and body movement records indicating all periods where SDB is present or absent. The specialist would review sleep sounds for signs of SDB and movement data for evidence of sleep quality (e.g. Insomnia related 10 stimulant d ug therapy*.
  • sleep quality e.g. Insomnia related 10 stimulant d ug therapy*.
  • RNT Specialist A data package of SBD sound samples such as snoring would be sent prior to and after adeno-tonsillectomy to indicate proof of SDB and evidence of treatment outcome.
  • Sleep Specialist This specialist receives a data package containing the full nights sound (i.e. any SBD and non SBD breath sounds) and body movement records indicatin all periods where SDB is present or absent. The specialist would review sleep sounds for signs of SDB and movement data for evidence of sleep quality. Samples from the felus of palpable fetal movements and fetal heart sounds would be included in this package. Obstetrician Specialist: A data package of sample breathing sounds would be sent to show lhat no SBD is present.
  • Clinical Vignette A 25 year old woman who is 29 weeks pregnant has noticed marked ankle swelling. She has gained more than expected weight. Her blood pressure is just below the upper limit of normal and she has no proteinuria. The high risk physician who sees her elicits a history of recent onset of an unusual form of snoring and refers her to a sleep physician. The sleep study shows long periods of obstructed snoring but no sleep apnea. On this night she has blood pressure recorded simultaneously with a portable oscillomctric system that measures blood pressure every hour. During the night the blood pressure goes to very high levels during the periods of snoring, but returns lo normal on waking. Fetal movements and heart sound are recorded.
  • Sleep Specialist This specialist receives a data package containing the full nights sound (i.e. any SDB and non SDB breath sounds) and body movement records indicating all periods where SDB is present or absent. The specialist would review sleep sounds for signs of SDR and movement data for evidence of sleep quality. Samples records (not full night) from the fetus of palpable fetal movements and fetal heart sounds would be included in this package as would a summary of the blood pressure information. Following implementation of CPAP this specialist would review the same post treatment data package.
  • Obstetrician Specialist high risk patients: A data package of sample breathing sounds would be sent to show that SDB is present. A full night record of the studies fetal movements (palpable vibrations) and fetal heart sounds wound be sent and reviewed by sound and touch as would the full night blood pressure data. Following implementation of CPAP this specialist would review the same post treatment data package to review treatment effects on the babies health
  • Example (6) Adult bruxing and snoring f 00651 Clinical Vignette: A 35 year old male reports heavy snoring. He is referred to a sleep physician who orders a sleep study that reveals mild sleep apnea and then refers the patient for a MAS (oral splint). The mat study reveals both snoring and bruxing and indicates that CPAP is a more suitable option as well as a bruxing oral splint (that don't work for snoring and apnea). A repeat study shows that bruxing is greatly reduced when CPAP is used— we now know that bruxing is induced with brief awakenings.
  • Sleep Specialist Following fitting of the MAS this specialist receives a data package containing the full nights sound (i.e. any SDB and non SDB breath sounds) and body movement records indicating all periods where SDB is present or absent. The specialist would review sleep sounds for signs of SDB and movement data for evidence of sleep quality. The package would also include all sound records of bruxing enabling the specialist to look at the temporal relationship of the bruxing to ihe SOB. Following implementation of CPAP therapy this specialist would review the same post treatment data package to review treatment efficacy
  • Dentist After MAS fitting a data package of sample breathing sound records would be sent to show that SDB is still present. A full night record of the bnixing sounds would also be included so the dentist could assess bnixing severity. Following implementation of CPAP the dentist would review the same post treatment data package to review treatment effects of the new splint on bnixing.
  • Pulmonary Specialist Jlie specialist reviews a full night's sound record ⁇ lung sounds on nights when the patient (or automated analysis software) has identified that infection may be present. The specialist reviews the sound record's to identify wheeze and crackle sounds indicative of lung infection and contacts the patient to organize and monitor treatment. All subsequent night's records are sent as data packages and reviewed until lung sounds indicate that the infection has been successfully treated
  • Patient and Carer The patient or carer reviews lung sound file data packages composed of the full nights records either manually or if an auto analysis software program indicates that infection related sounds may be present. If infection is suspected then full sound records arc sent to the specialist (manually or automatically) and discussed. Treatment is commenced as appropriate and similar data package records reviewed daily until infection is no longer present.
  • Clinical Vignette A 72 year old woman has long standing hypertension. Recently she has begun waking early in the morning with brcaihlessness. Her partner describes periods in which she is both snoring and stopping breathing. The primary care practitioner refers her to a cardiologist, who in turn refers her to a sleep physician because of the symptoms of sleep apnea- The sleep study shows central sleep apnea, and the snoring occurs during the breathing recovery. The central sleep apnea progressively worsens throughout the night and she develops lung crackles. The study reveals that the problem is not sleep apnea, but worsening heart failure and following more effective treatment of hypertension and diuretics she improves. A repeat study shows that both the central apnea and snoring have stopped as has the breathlessness at night
  • Sleep Specialist This specialist receives a data package containing, the full nights sound (SBD and non SBD breath sounds) and body movement records indicating all periods where SD13 is present or absent.
  • the package would also include samples of lung crackles sound records showing their temporal relationship with apnea. After treatment implementation they receive the same data package from a follow-up study to show treatment efficacy.
  • Cardiology Specialist This specialist receives a full nights sound records of all the periods involving crackle sounds as well as periods where these sounds are absent. This specialist receives samples sound records of SDB sounds indicating snoring or apnea and the temporal , relationship to the onset of crackles. After treatment implementation they receive the same data package from a follow-up study
  • Clinical Vignette A 62 year old overweight man reports waking with breathlessness at night and has noted irregular heartbeats. He snores but has no other history of sleep apnea. He is referred to a cardiologist who does a Holter monitor study that shows extensive heart rate variability during the night with periods of very slow heart rate. He arranged for him to have a cardiac pacemaker. Durin his stay in hospital the staff notice that he has apneic events. He is referred for a sleep study and there is clear repetitive obstructive apnea that are triggering marked slowing of the heart. The episodes of sleep apnea are triggering the heart block. He goes ahead with the pacemaker, but is also pul on CPAP thai greatly reduces the night time bradycardia events.
  • This specialist receives a data package containing the full nights sound (SDB) This specialist receives a data package containing the full nights sound (SBD and non SBD breath sounds) and body movement records indicating all periods where SDB is present or absent and non SDB breath sounds) and body movement reeords indicating all periods where SDB is present or absent.
  • Cardiology Specialist This specialist receives a data package containing sample night sounds (SDB and non SDB breath sounds), heart sound and body movement records indicating periods where SDB is present or absent and exemplifying the temporal relationship of the apnea with the bradycardia.. After CPAP and pacemaker treatment implementation they receive the same data package from a. follow-up study to show treatment efficacy.
  • riirtiral Vignrttf ⁇ thin ⁇ 8 year old woman wakes with transient right sided paralysis. She is admitted to hospital for observation. Assessment of her brain and carolid arteries show that she has marked caoiiid ailieiuuio. Tlic ti. i»iciu stroke is thought to be the resuJt of carotid artery plaque rupture. The neurologist elicits a long history of heavy snoring- The woman has not previously revealed this problem out of embarrassment. A sleep physician is consulted and a sleep test is done. The test shows very obstructed snoring for most of the night, but only minor episodes of complete apnea.
  • Neurologist Specialist This specialist receives a data package containing sample night SDB sounds. After CPAP treatment implementation they receive the same data package from a follow-up study to show treatment efficacy.
  • the present invention provides a solution to the above and other diagnostic and clinical problems by providing measured, prescriptive or predictive data packages relating to the patient conditiotvincluding recorded sounds (e.g. snoring) which can be reproduced for any interested party.
  • An advantage of the present invention is that the patient data package can encompass a variety of time periods such as hours or multiple days or nights and can capture varying physical signs that indicate fluctuations in disease severity. This is of particular advantage in providing long term at home (or in hospital) surveillance of chronic diseases such as most forms of chronic lung disease fe.g. cystic fibrosis and asthma), and chronic heart disease ( heart failure for example) where early changes indicative of deterioration can be identified and earlier treatment intervention initialed so to prevent deterioration.
  • chronic diseases such as most forms of chronic lung disease fe.g. cystic fibrosis and asthma
  • chronic heart disease heart failure for example
  • Another unique aspect of the system according to the present invention is that it can record all night and for as many nights as needed to overcome the problem of inaccurate patient or partner reports of snoring which can be exaggerated due to the absence of a reference to what is acceptable, normal or abnormal or serious.
  • the present invention ameliorates this problem.
  • patient pathologies which can be treated in different ways. For example sleep apnea can be treated with various therapies including the use of the oral anti snoring /device (MAS).
  • MAS oral anti snoring /device
  • Many GPs and Sleep Physicians are reluctant to recommend this form of therapy because currently the patient must undergo expensive dental fitting of such a device (with costs in the AU$1500 vicinity) in order to lind out if it works.
  • MAS devices can be effective in treating both snoring and obstructive apnea, there is a pressing need to be able to assess the patient before and during treatment.
  • there is a very variable-response to such devices about 30% of all patients with snoring and or sleep apnea have an excellent response to MAS treatment.
  • about 25 to 30% either have no response or get worse on this therapy, and the rest have some improvement.
  • the OP and Sleep Physician's reluctance is also caused by the fact that in general the only feedback that occurs on the effectiveness of the device comes from the patient reporting that their spouse thinks it works.
  • the present invention allows the dentist to provide the patient, the patient's partner and the sleep physician with the evidence of the physical signs by using the data packages.
  • a dentist /orthodontist found that many of his referred patients took up the option of using an oral device ( MAS) after hearing what they sounded like at night, whereas before these patients had refused to try the therapy.
  • MAS oral device
  • the present invention provides advantage in the treatment of Asthma by enabling recording and collection of data at home over many night"? related to a child's asthma.
  • asthma is poorly managed and treated because the GP and physician have to rely almost entirely on the reports from parents. This leads to both under-treatmeni and over-treatment— in the latter case with many children are being put. on high doses of inhaled steroids unnecessarily.
  • asthma may coexist with obstructed breathing which may further complicate identification and effective treatment.
  • the measured data obtained from sensors and records of sounds from a subject who may have signs of asthma increases the accuracy of diagnosis and treatment options by manually or automatically analysing and identifying sound signals which then indicate presence or absence of disease.
  • the data collected and used allows using data packages a method of analysis in which the energy of vibrational signals may be quantified for determination of various pathologies such as but not limited to stroke, carotid damage prediction or detection. More particularly the signals from the data packages may be standardised for the purpose of measuring a parameter. For Instance the practitioner can stant!nrd+s;; a-sigaal or est of-signak to determine how energy in the signal is related to the pathology of a subject. ⁇ total amount of energy used in a snore for example can be used to create an index to compare over time a risk of a pathology in a given patient or group of patients.
  • a reference signal or index can be set up for a patient to determine pathology such as tissue damage, eg vascular carotid artery, nerve damage.
  • Deduction can be made based on the energy of the signal with the energy forming a baseline reference for patients.
  • This baseline can be built up over lime to quantify what implications a data package might have for diagnostic purposes.
  • ⁇ relationship can be made between the energy of a signal and a particular patholog or severity of a condition or state of anatomy. his can allow the creation of indexes or bench marks for patients or groups of patients over time.

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Abstract

L'invention concerne un système fournissant au moins un ensemble de données cliniques obtenues à partir d'un patient et la transmission dudit récepteur de données pour permettre l'identification et/ou le diagnostic et le traitement d'une pathologie du patient déterminée à partir de l'ensemble des données. Le système inclut un assemblage comprenant au moins un capteur capable de détecter des données à partir du patient. L'au moins un capteur de données détecte les données, sur une période de temps prédéterminée, et la transmission dudit au moins un ensemble de données audit récepteur des données. Les données incluent les paramètres du patient incluant le mouvement corporel et les sons de la respiration, le son ambiant local, le son de l'auscultation, liés à une pathologie du patient. Le système permet aux récepteurs desdits ensembles de données de reproduire les données sur un dispositif de sons et/ou vidéo pour détecter les données de vibrations permettant de cette façon au récepteur de simuler un examen physique du patient.
PCT/AU2012/000606 2011-05-31 2012-05-31 Système de surveillance électronique pour la production d'ensembles de données dans des buts d'analyse et de diagnostic WO2012162740A1 (fr)

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US11401508B2 (en) 2016-11-29 2022-08-02 Procella Therapeutics Ab Methods for isolating human cardiac ventricular progenitor cells
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