WO2016049711A1

WO2016049711A1 - Apparatus and system for physiological monitoring

Info

Publication number: WO2016049711A1
Application number: PCT/AU2015/050607
Authority: WO
Inventors: Ross Francis SMITH
Original assignee: Smith Ross Francis
Priority date: 2014-10-03
Filing date: 2015-10-06
Publication date: 2016-04-07

Abstract

A system for monitoring the physiology of a patient, comprising a patient monitor, a remote processing apparatus, in communication with the patient monitor via a communications network, and a mobile processor. The patient monitor is configured to collect one or more monitored variables of the patient; display clinical information, provide at least one alert and transmit data via an output means. The remote processing apparatus is configured to receive the transmitted data, connect with one or more database and retrieve information therefrom and compare the retrieved information with the transmitted data; and transmit the compared data to generate modified alert parameters. The mobile processor is configured to display at least part of the clinical information and provide the alert and/or the modified alert.

Description

APPARATUS AND SYSTEM FOR PHYSIOLOGICAL MONITORING

Field of the Invention

[001 ] The present invention relates to an apparatus and system for physiological monitoring of a patient, and in particular to an apparatus and system for anaesthetic monitoring.

[002] The invention has been developed primarily for use in/with apparatus and system for anaesthetic monitoring and will be described hereinafter with reference to this application. However, it will be appreciated that the invention is not limited to this particular field of use, and includes other physiological monitoring of a patient required in various medical procedures and environments.

Background of the Invention

[003] Apparatus and system for physiology monitoring generally involve collecting various categories of data from the patient being monitored In the specific field of anaesthetic monitoring, this can include data such as:

(a) Primary physiological variables e.g. Pulse rate, blood pressure SpO2, ETCO2

(b) Anaesthetic Machine Variables including Ventilation parameters, or inspired and expired anaesthetic vapour levels

(c) Derived physiological variables including Cardiac output, Entropy, BIS

(d) And Alert Values and Alert States

[004] Generally a clinician determines alerts with traditional monitoring systems using the following model: i) The patient monitoring machine has some in-built default alert limits for adult and paediatric patients. ii) After the case is started if an alert is alerted the clinician generally acts on the alert and corrects the physiological state so that the alert ceases.

[005] However such data is a combination of the immediately collected data of the current patient and the data of the particular machine. Often therefore the set-up of alerts and trends will not adequately reflect the particular patient and incorrect alerts or trends can be initiated, which are not beneficial to correct treatment for the patient.

[006] Further, any single patient could have undertaken various operations over the years in various hospitals. The data and history from one location to another is often not available or not interpreted at the new location. This can be due to a time or expense issue or merely due to a consideration that there is no real opportunity to use such information. If there is an opportunity, this might be a decision making point at a critical time in the medical procedure due to an unexpected variation in the monitored variables of the patient.

[007] Still further, any particular hospital could have a particular cross-section of patients and the monitoring equipment has its predefined alert values and alert states set to a general average or a wide spectrum in order to not activate too many false alert stages. The particular patient might not fit the usual cross-section or the states might only be roughly tuned for the patient. Therefore the "best-fit" alert stages of this particular patient are not used.

[008] The present invention seeks to provide an apparatus and system for physiological monitoring, and anaesthetic monitoring in particular, which will overcome or substantially ameliorate at least one or more of the deficiencies of the prior art, or to at least provide an alternative.

[009] It is to be understood that, if any prior art information is referred to herein, such reference does not constitute an admission that the information forms part of the common general knowledge in the art, in Australia or any other country.

Summary of the Invention

[0010] According to a first embodiment of the present invention, there is provided a system for monitoring the physiology of a patient, comprising:

[001 1 ] a patient monitor configured to: collect one or more monitored variables of the patient; display clinical information relating to the patient based on the one or more monitored variables; provide at least one alert in response to a pre-determined parameter, whereby the alert is generated when one or more of the monitored variables matches a programmed trigger threshold value; and transmit data via an output means connected to a communication network, the data being any one or more of the collected one or more monitored variables, the clinical information and the at least one alert;

[0012] a remote processing apparatus, in communication with the patient monitor via the communications network, and configured to: receive the transmitted data from the patient monitor; connect with one or more databases containing information of the patient under anaesthetic and actual and/or theoretical information of other patients; retrieve the information from the one or more databases; compare the retrieved information with the transmitted data; and transmit the compared data and information via a second output means connected to the communication network, thereby generating modified alert parameters; and

[0013] a mobile processor configured to: display at least part of the clinical information; and provide the at least one alert and/or the modified alert.

[0014] Preferably, the mobile processor is further configured to receive one or more commands from a user, which are transmitted via the communication network to one or both of the remote processing apparatus and the patient monitor.

[0015] Preferably, the one or more commands include user defined modification of the alert parameter.

[0016] Preferably, the user defined modification of the alert parameter assigns a patient identifier to the modified alert parameter, which is unique to the patient.

[0017] Preferably, the user defined modification of the alert parameter assigns one or more patient classifiers to the modified alert parameter, each patient classifier being relevant to a particular classification of the patient under anaesthetic and that is also a relevant particular classification to other patients.

[0018] Preferably, the unique patient identifier and patient classifier are transmitted via the communication network to the remote processing apparatus and are stored in one or more databases connected thereto.

[0019] Preferably, the compared data and information is based only upon the patient under anaesthetic as identified by the patient identifier. [0020] Preferably, the compared data and information is based upon both the patient under anaesthetic and other patients in the relevant classification to the patient as identified by one or more of the patient classifiers.

[0021 ] Preferably, the alert parameter includes assessment based on particular patient data obtained in real time when the parameter is set-up.

[0022] Preferably, the alert parameter includes assessment based on particular patient data obtained historically.

[0023] Preferably, the alert parameter includes assessment based on other medically similar particular patient data obtained from other medically similar patients.

[0024] Preferably, the information in the one or more databases includes real individual user data, or real multiple individual user data, or statistically acceptable theoretical or conglomerated data that follows a theoretical hypothesis accepted by peer review scientific analysis, a range of actual and theoretical data to determine advisory alerts and data representations for use by a medical professional for anaesthetic monitoring of the patient.

[0025] Preferably, the information can be updated from a range of locations and over a range of time.

[0026] Preferably, the information of the patient under anaesthetic and actual and/or theoretical information of other patients includes medical patient information from operations performed in the past in one or more locations, including medical procedure type, medical procedure site and other patient parameters.

[0027] Preferably, the information includes one or more of patient descriptive data, user preference data, anaesthetists data and patient physiological data.

[0028] Preferably, the remote processing apparatus processes patient information, big data analytics and advisory alerts.

[0029] Preferably, wherein the mobile processor is one or more of a tablet computing device, a smart phone, a heads up display unit or a telecommunication device.

[0030] Preferably, the physiology relates to anaesthetic monitoring, and the monitored variables comprises one or more of the following heart rate, blood pressure invasive (if present) and non-invasive, Sp02, ETCo2, BIS/Entropy if present, ET Anaesthetic Agents, and User-determined physiological Data.

[0031 ] Preferably, the alert includes a visual data representation in the form of a graph of one or more of the monitored variables. [0032] According to another aspect of the present invention there is provided a system for monitoring the physiology of a patient, comprising:

[0033] a patient monitor configured to: access a database of usual alert parameters for a patient being monitored; select a first one of a plurality of alert parameters for the patient; determine the first alert parameter for the patient with particular data related to the patient; and transmit the first alert parameter as determined via a communications network, collect monitored variables of the patient and transmit the collected monitored variables via a communications network;

[0034] a remote processing apparatus in communications with the patient monitor via the communications network and configured to: receive the first alert parameter from the patient monitor via the communications network; receive the collected monitored variables from the patient monitor via the communications network; connect with a database; process the first alert parameter to compare the monitored variables of the patient from the measuring device per the command and monitored data relating to the patient and/or relating to other patients; transmit said compared data via the communications network or an alert signal to generate an alert based on the collected monitored variables of the patient approaching the first alert parameter as determined from the compared data; and

[0035] an alert device in communications with the remote processing apparatus via a communications network and configured to: receive the compared data relating to the patient via the communications network; and/or receive an alert signal to generate an alert based on the collected monitored variables of the patient approaching the first alert parameter as determined from the compared data.

[0036] According to a further aspect of the present invention, there is provided a method for monitoring the physiology of a patient, the method comprising the steps of: assigning a first one of a plurality of alert parameters to the patient using a patient monitor, wherein the first alert parameter includes a command for collecting monitored data relating to the monitored variables of the patient; transmitting particular data relating to the patient from a monitor to the patient monitor via a communications network; customizing the first alert parameter to the patient with the particular data related to the patient; transmitting the first alert parameter as determined from the patient monitor to a remote processing apparatus via the communications network; executing the first alert parameter in the remote processing apparatus to receive the monitored data from a measuring device per the command; transmitting the monitored data from the remote processing apparatus to the patient monitor via the communications network; storing the monitored data in a database accessible to the patient monitor; receiving an alert signal wherein the alert signal is: generated based on the monitored data and available at the monitor for review by a medical practitioner; generating a modified alert based on said monitored data.

Brief Description of the Drawings

[0037] Notwithstanding any other forms which may fall within the scope of the present invention, a preferred embodiment / preferred embodiments of the invention will now be described, by way of example only, with reference to the accompanying drawings in which:

[0038] Figure 1 is a diagrammatic view of an apparatus and system for physiological monitoring, and anaesthetic monitoring in particular, in accordance with a preferred first embodiment of the present invention;

[0039] Figure 2 is a diagrammatic view of an apparatus and system for physiological monitoring, and anaesthetic monitoring in particular, in accordance with a preferred second embodiment of the present invention;

[0040] Figure 3 is a diagrammatic view of a driver for use in an apparatus or system for physiological monitoring in accordance with a preferred embodiment of the present invention such as in Figures 1 or 2;

[0041 ] Figure 4 is a diagrammatic view of steps in a system for use in an apparatus or system for physiological monitoring in accordance with a preferred embodiment of the present invention such as in Figures 1 or 2;

[0042] Figure 5 is a diagrammatic view of a system for physiological monitoring, and anaesthetic monitoring in particular, using cloud processing in collation of a range of patient data in accordance with a preferred embodiment of the present invention;

[0043] Figures 6 and 7 are general diagrammatic views of the processing of a system for physiological monitoring using the cloud collation of patient data of Figure 5 and cloud processing and storage in accordance with a preferred embodiment of the present invention.

Description of Embodiments

[0044] It should be noted in the following description that like or the same reference numerals in different embodiments denote the same or similar features.

[0045] Referring to Figures 1 and 2 there are shown two general forms of apparatuses for physiological monitoring, and anaesthetic monitoring in particular, of a patient. Figure 1 shows the use of the invention in a new version of monitoring machine 20 so that it is able to be a slave-like machine that interacts with a remote computer apparatus 30 which could be the cloud, or remote server or website or the like. This could be driven by a driver 50 in the monitoring machine 20 or by use of the separate mobile processors 40 which could incorporate the driver 50. However in Figure 2 there is shown another version which uses the use of separate mobile processors 40 that become the driver 50 of the In this way retrofitting to known monitoring machine 20 can occur and upgrading of current systems to the improved systems of the invention can occur without replacing current monitoring machines 20.

[0046] In Figure 1 there is shown a modified monitoring machine 20 having a monitor 21 for monitoring, in this case, the administering of an anaesthetic to a patient 1 1 and receiving monitoring data from the patient. In this case, the anaesthetist machine 20 can include a database 25 which has a library of usual patient data and thereby provides alerts when the monitored data of the patient fulfils the alert parameters defined by the library. The alerts can be sent to a display/alarm 29.

[0047] This display/alarm could be integral with the monitoring machine 20 or separate or integrated in other equipment such as wirelessly connected separate mobile processors 40. Such processors 40 could include a mobile phone 41 such as an Apple™ or Android™ based smart phone or a notebook 42 or portable terminal 43.

[0048] Included in the monitoring machine 20 is a communication interface 22 acting as a signal transmitter/receiver which can allow communication between the monitoring machine 20 and a remote processing apparatus 30. This connection allows two benefits. Firstly it allows more complex processing to be undertaken by a remote processing apparatus 23 at the remote computer apparatus 30, which could be the cloud, or remote server or website. Further as shown in Figure 5, by using the cloud 166 or the like, the apparatus for monitoring 20 can use data of current patient and theoretical data or actual data of other patients in a library of patient data 24, being databases connected to the remote processing apparatus 23.

[0049] The apparatus for physiological monitoring is able to process data at the remote processing apparatus 30 and receive alerts directly from the remote processing apparatus 23 according to the processed data.

[0050] The apparatus for physiological monitoring 20 includes a second communication interface for wireless communication 27B to a telecommunication device being the wirelessly connected separate mobile processors 40. In this way the medical user is not restricted to location with the monitor 21 of the apparatus for anaesthetic monitoring 20 but can undertake monitoring of the patient separately to the actual data of the current patient. Further the medical user is able to communicate with the wirelessly connected separate mobile processors 40 directly to and from the remote processing apparatus 23 by wireless connection 27A. This wireless connection 27A could be via separate internet connection or through relays. In this way the medical user can be in control or aware of the actions of the remote processing apparatus 23.

[0051 ] Further the display/alarm 29 that receives alerts or data representations from the remote processing apparatus 23 or from the monitor 21 can be integral with the wirelessly connected separate mobile processors 40 or could receive a mirrored version of a separate stand-alone display/alarm 29 or receive a separate version of the alerts or data representations.

[0052] In use the patient monitor 21 is configured to access a database 25 of usual alert parameters for a patient under anaesthesia and select a first one of a plurality of alert parameters for the patient. This is determined for the patient with particular patient descriptive data 212U related to the patient. Also the monitor 21 further collects monitored variables of the patient and transmits via the first communication means including the signal receiver 22 the collected monitored variables to the remote processing apparatus 30. The apparatus for anaesthetic monitoring is able to receive transmit the first alert parameter as determined via a communications network or signal processor 23 from the remote processing apparatus which is in communications with the patient monitor via the communications network.

[0053] In Figure 2 there is the physiological monitoring machine 20 having a database 25 which has a library of usual patient data and thereby provides alerts when the monitored data of the patient 1 1 fulfils the alert parameters defined by the library 25. The alerts can be sent to a display/alarm 29.

[0054] However such a physiological monitoring machine 20 merely needs a wireless connection to allow the substantial improvement of the current system. This wireless connection can be a dongle 26 inserted into a USB receiving port which can instigate a primary wireless communication 27A between one of the wirelessly connected separate mobile processors 40 and the anaesthetist machine 20. Such processors 40 could include one of a mobile phone 41 such as an Apple™ or Android™ based smart phone or a notebook 42 or portable terminal 43.

[0055] The wirelessly connected separate mobile processor 40 allows communication 27B to the remote processing apparatus 23 at the remote computer apparatus 30, which could be the cloud, or remote server or website. This can allow the more complex processing to occur at the remote processing apparatus 23. It also allows use of data of current patient and theoretical data or actual data of other patients in a library of patient data 24, being databases connected to the remote processing apparatus 23. This collection of further data into the library of patient data 24 is facilitated, as shown in Figure 5, by using the cloud 166 or the like.

[0056] The alerts determined by the remote processing apparatus 23 can be sent wirelessly by wireless communication 27C from wirelessly connected separate mobile processor 40 to the display/alarm 29 or directly from the remote processing apparatus 23 and to the display/alarm 29. However the display/alarm 29 that receives alerts or data representations from the remote processing apparatus 23 or from separate mobile processor 40 can be integral with the wirelessly connected separate mobile processors 40 or could receive a mirrored version of a separate stand-alone display/alarm 29 or receive a separate version of the alerts or data representations.

[0057] Referring to Figure 3 there is shown the driver of the system which could be incorporated in the physiological monitoring machine 20, such as an anaesthetic monitoring machine, or separate mobile processors 40 of Figure 1 or in the separate mobile processors 40 of Figure 2. [0058] The driver 50 is a computing device for use in processing real time content to facilitate physiological monitoring of a patient. The computing device comprises a processor 51 with associated RAM 52 controlled by a computer program code for processing digital data, a memory device in the form of ROM 54 for storing digital data including the computer program code and all being coupled to the processor 51 via a bus 55. An input means in the form of an Input/Output interface 61 is for receiving in real time one or more monitored variables of a patient 1 1 such as from the monitor 21 . Output means, in the form of a display interface 62, is for providing alerts and/or data representations to a display/alarm 29. As detailed previously, this display/alarm can be integral with the wirelessly connected separate mobile processors 40 or could be a separate stand-alone display/alarm 29.

[0059] The monitored variables of a patient 1 1 , such as from the monitor 21 , is compared with the alert parameters stored in the library of usual patient data 25 which can be received with the monitored variables from the monitor through the input/output interface 61 and into the memory 52, 53. The provided alerts are based on processed digital data of alert parameters including in relation to the received one or more monitored variables of a patient. These variables will differ in accordance with the particular physiological monitoring that the machine 20 is carrying out, but will include such variables as heart rate, blood pressure invasive (if present) and non-invasive, SpO2, ETCo2, BIS/Entropy if present, ET Anaesthetic Agents, and User-determined physiological data. This is particularly the case where the physiology monitoring machine 20 is an anaesthetic monitoring machine.

[0060] The computing device can further include a communication interface in the form of a network interface 63 that is wirelessly connected to the cloud 166 for sending and receiving digital data and being coupled to the processor 51 via the bus 55. The processor 51 is controlled by the computer program code to send, via the communication interface 63, to a remote processing apparatus 23 in the cloud 166, data indicative of the monitored variables and/or alert parameters of the patient and receive from the remote processing apparatus via the communication interface 63 alerts specific to the medical user from the server.

[0061 ] The processor 51 can be further controlled by the computer program code to receive, via the communication interface 63, alerts specific to the patient from the remote processing apparatus 23 in the cloud 166 alert data selected by the remote processing apparatus according to a comparison of patient data and remotely stored patient data.

[0062] Still further the processor can be further controlled by the computer program code to receive, via the communication interface 63, alerts specific to the patient from the remote processing apparatus 23 in the cloud 166, alert data selected by the remote processing apparatus according to a comparison of patient data and historical data of current patient and/or to actual data or theoretical of other similar patients in databases connected to the remote processing apparatus.

[0063] In general the medical user, which can be the anaesthesiologist, determines alerts with traditional monitoring systems but not beyond only using the inbuilt default alert limits for adult and paediatric patients.

[0064] After the case is started if an alert is alerted, the medical user generally interprets the alert as an aberration, which is temporary and expect it to cease. For example, in the case of anaesthetic monitoring, if the pulse oximeter and blood pressure cuff are on the same alert, there will be a pulse oximeter alert whenever the blood pressure cuff is inflated. There are some anaesthetic monitors which allow the anaesthetist to accept current physiological values as the default values. The anaesthetist is requested to press a menu button which changes all the alert parameters to within a given percentage e.g. +/-20% of the current physiological values.

[0065] However, the present system further has the processor 51 controlled by the computer program code to provide alerts or alert parameters wherein a modified alert is able to be determined by the user by available alerts, or data representations of alert parameters. A modified alert can be automatically determined from available alerts, or data representations of alert parameters and a comparison of patient data and historical data of current patient and/or to actual data or theoretical of other similar patients

[0066] It is important that such decisions are based on objective rather than subjective interpretation. Therefore, with reference to Figure 4, there is the general procedure in which the remote processing apparatus 30 is configured to receive the first alert parameter of advisory alerts 164 from the patient monitor 21 which monitors or senses data of patient in step 151 . This data is formatted and sent in step 152 via the communications network including the received collected monitored variables from the patient monitor. The data is received and processed in step 153 and can in step 154 require formatting so that data can be compared in similar form and in similar scales. Following comparison of the data there can be step 155 to determine the relevance to the patient. This can include the likelihood that the comparison is correct or the sequence of monitored parameters. This step can include a review of data representations by the medical user and then the following step 156 is to provide the alert in order to assist in the monitoring of the patient.

[0067] In the steps 154, 155 and 156 there can be an assessment of the historical flow of alerts. That is the state of anaesthesia can be based on an expected flow of changing The processing of the first alert parameter by comparison the monitored variables of the patient from the measuring device per the command and monitored data relating to the patient and/or relating to other patients; transmit said compared data via the communications network or an alert signal to generate an alert based on the collected monitored variables of the patient approaching the first alert parameter as determined from the compared data.

[0068] It is therefore beneficial to use not only the current patient data but historical patient data and data of similar patients.

[0069] This comparison with not only the current patient data but historical patient data and data of similar patients is particularly available when using processing in the cloud as shown in Figure 5. The cloud 166 provides the substantial benefit that it is able to receive from a range of locations and over a range of time and then process and communicate a range of actual and theoretical data to determine advisory alerts and data representations for use by the medical professional for monitoring of a patient. The data can be real individual user data, or real multiple individual user data, or statistically acceptable theoretical or conglomerated data that follows a theoretical hypothesis accepted by peer review scientific analysis.

[0070] Therefore the data able to be used due to the invention is not only a combination of the immediately collected data of the current patient and the data of the particular machine but also the set-up of alerts includes trends which can adequately reflect the particular patient from data from similar patients in similar conditions. Correct alerts or trends can be initiated based on this expected result, which is beneficial to correct treatment for the patient.

[0071 ] Further, any single patient could have undertaken various operations over the years in various hospitals. The data and history from one location to another will now be available for use and interpretation at the new location. This can substantially assist at a decision making point at a critical time in the procedure due to an unexpected variation in the monitored variables of the patient as the medical user has a series of data based on peer reviewed theoretical data, conglomerated big data from multitude of similar patients and/or historical information of current patient.

[0072] Still further, any particular hospital having a particular cross-section of patients and the monitoring equipment can have its predefined alert values and alert states set to a general average or a wide spectrum in order to not activate false alert stages. The particular patient might fit the best-fit alert stages of this particular patient which can now be selected and used.

[0073] Such comparisons are substantially useful in real time during a procedure as there are several areas that this could be used. This includes: a) Pre-emptive alert of trending parameters heading in an inappropriate direction b) Pre-emptive alert of big data analytics of multiple parameters which could forewarn of impending complications. This may allow detection of complications to occur well in advance of simple monitoring of individual physiological parameters. The analytics would be performed on the server using well- researched and referenced analytical techniques to detect specific complications. c) Alert of monitor machine status.

[0074] Referring to Figure 6 It is then necessary to perform comparisons between patient data and cloud data. This is undertaken in three primary steps including Collection of Data, Processing of Data, and Advisory alert system.

[0075] In the Collection of Data and storage into database linked by fields:

[0076] Procedure type

[0077] Medical User ID [0078] Surgeon

[0079] Procedure site

[0080] Patient parameters

[0081 ] In the Processing of Data analytics across all files from all users

[0082] In the Advisory alert system to be returned to individual users if there is a data analytics alert alerted.

[0083] As shown in Figure 7, the data can be patient descriptive data 212U, user preference data 212PR, alarm data 212A or patient physiological data 212PH.

[0084] The data (i.e. past patient data) which would be collected in the cloud includes parameters which would be similar to that determined by the existing physiology monitoring device but previously never collected or collated and used in future uses. There would be the ability to present the data in a number of Data Representations.

[0085] Referring to Figure 7 in the cloud data system 166 of Figure 6 there are three primary processes. These include processing patient features 21 1 , processing big data analytics 221 and processing advisory alerts 231 .

[0086] In the processing of user features 21 1 there would be an eco-system developed which would allow logging of an individual anaesthetist's cases incorporating an associated web page would allow users to visit and alter some parameters and view their cases.

[0087] Descriptive Data includes: a) Medical User's name and unique id b) Time and Date

c) Geodata representation in the form of a graphic

location d) Name of healthcare facility

e) Case classification - from pop-up list

f) Surgeon name g) Patient Medical record Number h) Patient gender, age , weight, height

[0088] User Preference Data includes: a) Define and enable the user to be able to alter the

default parameters to be collected and displayed b) The last used parameters to be collected

displayed on the app.

c) Define and enable the user to be able to alter the

default Data Representations d) The last used Data Representations e) Define and enable the user to be able to change the

default Sonifications to be used. f) The last used Sonfications

g) Define and enable the user to be able to change the

default the layout, colour and other visual aspects of

the app.

[0089] Alert Data: a) Time of alert

b) Type of alert

[0090] Physiological Data including mandatory physiological data, which can include, particularly in the case of anaesthetic monitoring: a) heart rate b) blood pressure invasive (if present) and

non-invasive c) Sp02 d) ETCo2 e) BIS/Entropy if present f) ET Anaesthetic Agents g) And User-determined physiological Data:

[0091 ] These would be all of the physiological values that are currently selected by the user from within the peripheral monitoring device which that are not in the mandatory set of physiological data. The cloud based system would perform several other functions including Cloud Based Big Data Analytics. This would be a subscription service which would provide access to big data analytic algorithms. These algorithms would provide pre-emptive determination of altered physiological states.

[0092] The algorithms can include: a) Documented in the peer-reviewed scientific literature b) Open source c) De-identified data collected from the proposed system would be used to datasets for future analysis.

[0093] Advisory Alerts from the big data analytics system are generated by the cloud-based analytics service which would be delivered to the user's display or smartphone in real-time.

[0094] Also the display/alerts 29 will receive an alert signal to generate an alert based on the collected monitored variables of the patient approaching the first alert parameter as determined from the compared data.

[0095] This bulk data can be provided automatically by sonifications or by predefined or remotely determined alerts or could be provided with different Data Representations (DRs) delivered to the user screen. The Data Representations(DRs) would be defined either on the eco-system web-page or from within the app itself. Altered data representation can occur in the form of a different graphical output depending on the relevant alerts.

[0096] The user would define multiple Data Representations(DRs), which could be accessed in 3 ways. These would include:

[0097] User would electively swipe between screens at any time which could be configured to show undefined number of Data Representations(DRs) on a user defined number of screens up to Max Number of about 20 screens.

[0098] User selected option to show different screens at different stages of anaesthesia: [0099] IF YES:

[00100] Induction e.g Standard Monitoring Screen

[00101 ] Steady state e.g 'cobweb' data representation in the form of a graphical output

[00102] Emergence

[00103] User selected option to show different screens in the event that aberration is detected by the switching mechanism

[00104] IF YES:

[00105] Define what Data Representations(DRs) to resend [00106] Highlight the aberrant variable clearly [00107] Audible Alerts and Sonifications

[00108] There are Sonifications used to wirelessly provide the user with real-time feedback on whether the anaesthetic and physiologic variables were in a steady state system - potentially using rhythmic beeps to indicate steady state physiological variables. Other sonifications indicate whether a switching mechanism had been activated. Further sonifications advise whether an advisory alert had been received from the cloud-based system.

[00109] Communication system between individual anaesthetists and other medical users can occur with email/ sms and bulletin board system which could be incorporated within the system to allow communication between users of the service

[001 10] Referring to Figure 7 there is provided the user descriptive data 212U which is static data associated with a particular patient and can include: i) Medical User's name and unique id

ii) Time and Date

iii) Geodata representation in the form of a graphic location

iv) Name of healthcare facility

v) Case classification - from pop-up list

vi) Surgeon name

vii) Patient Medical record Number viii)Patient gender, age , weight, height

[001 1 1 ] The user preference data 212PR is data expected to be relevant to the patient and is really the initial baseline for the anaesthetist to enter details into the monitor. This data can allow a) Definition and enablement of the user to be able to alter the default parameters to be collected and displayed

d) The last used parameters to be collected and displayed on the app.

e) Define and enable the user to be able to alter the default Data Representations f) The last used Data Representations

g) Define and enable the user to be able to change the default Sonifications to be used.

h) The last used Sonifications

i) Define and enable the user to be able to change the default the layout, colour and other visual aspects of the app.

[001 12] The anaesthetists alarm data 212A is an initial definition of when an alert or alarm should be instigated due to measured parameters. Therefore in effect this is defining a baseline for the alerts or alarms. Such alerts or alarms can instigate Sonifications so that an audible signal is available to the anaesthetist. This need not be a critical alarm but can be a sonification that provides further information such as looseness to the criteria matching of the predefined alarm parameter.

[001 13] The physiological data 212PH can be physiological data including mandatory physiological data includes: j) heart rate

k) blood pressure invasive (if present) and non-invasive

I) SpO2

m) ETCo2

n) BIS/Entropy if present

o) ET Anaesthetic Agents

p) And User-determined physiological Data:

[001 14] There are several unique variations including:

(1 ) The use of a wireless display based upon output from the Android™ app which has already been developed. (2) The use of Sonifications from the application to provide the user with regular feedback when physiological variations are within the normal range. This would be delivered using a wireless headset delivering Sonifications from the smartphone app.

(3) The use of a switching mechanism to allow the display on the smartphone screen or android app to change depending upon the alert status. The output would be dependent on the type of physiological aberration detected by the switching mechanism.

(4) The ability of the device to create the stable values similar to the way some current machines provide the ability for anesthetists to set the current physiological parameters as the basis for a new set of alert parameters.

(5) The system would allow for the detection of significantly abnormal values and request the user authorize these as new stable values prior to using them as the basis for any new alert parameters, rather than cart blanche acceptance of the new physiological parameters.

[001 15] The secondary components of the monitoring system can be mobile 41 , notebook 42 or terminal 43 that uses a smartphone type app with Bluetooth connection to anaesthetic monitor 21 . One embodiment is a device which connects with an Android device with AGE AiSys Anaesthetic monitoring system using an Off the shelf Bluetooth to Serial conversion device.

Interpretation - Description of Defined Terms

[001 16] Data Representations:

[001 17] A Data Representations(DRs) is a screen shown on a connected smart phone, tablet or laptop from the monitoring app. The user can define their own data representations or utilize pre-defined data representations. There is no limit to the number of data representation that can be defined for a given user. There is a limit to the number of screens that can be available on the app however. I suggest initially a limit of 20 screens which are viewed by swiping screens on the device.

[001 18] A Data Representations(DRs) has the following features: (1 ) It can either be defined by the user or provided as part of the proposed service

(2) The parameters shown reflect real time values available from the physiological monitor

(3) They can represent the data as a:

(a) Waveform

(b) Digital readout

(c) A novel data representation in the form of a graphical data representation

(d) The data can be included in a trend data representation in the form of a graph

[001 19] Sonifications:

[00120] Sonifications are short discrete sounds or sound patterns that carry information about the status of a variable. IT is anticipated that they would be developed to provide information on the following parameters: i) whether the anaesthetic and physiologic variables were in a steady state system - potentially using rhythmic beeps to indicate steady state physiological variables ii) whether there was a switching mechanism had been activated iii) whether an advisory alert had been received from the cloud-based system

[00121 ] Stable-Value (SV)

[00122] Stable values (SVs) are those values of physiological values that have been defined to be accepted for the specific anaesthetic event. There would be several ways of setting these variables.

[00123] Initially these would be set using pre-defined values based upon the age and gender of the patient.

[00124] At any point the anaesthetist can set the current existing values of the physiological parameters as the new Stable values. Acknowledgement would be required if these values were > x% from the existing values.

[00125] When a switching mechanism (see below) is activated then the user is given the option of accepting the current physiological value as being the new stable value.

[00126] Switching Mechanism(SW)

[00127] A switching mechanism (SW) is a alert parameter defined operation which alters the following items if the appropriate options have been selected.

(a) The Data Representation

(b) The sonification output

[00128] A switching mechanism will be activated if:

[00129] The valuable of a physiological variable, or a group of physiological variables, have exceeded a pre-defined envelope from their stable values , or ,

[00130] a cloud generated advisory alert is received to the connected device which is running the app.

[00131 ] Advisory Alert (AA)

[00132] An Advisory Alert(AA) is an electronic alert transmitted from the cloud based service. It will be created by big data analytic engine which will be analyzing data from the user's app in real time and comparing it to the existing algorithms in place on the web-based service.

[00133] The advisory alert will be delivered as a:

[00134] Text alert on the screen

[00135] An altered sonification alert and also

[00136] as an altered Data Representation if the user has selected this option [00137] Wireless:

[00138] The invention may be embodied using devices conforming to other network standards and for other applications, including, for example other WLAN standards and other wireless standards. Applications that can be accommodated include IEEE 802.1 1 wireless LANs and links, and wireless Ethernet.

[00139] In the context of this document, the term "wireless" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that may communicate data through the use of modulated electromagnetic radiation through a non-solid medium. The term does not imply that the associated devices do not contain any wires, although in some embodiments they might not. In the context of this document, the term "wired" and its derivatives may be used to describe circuits, devices, systems, methods, techniques, communications channels, etc., that may communicate data through the use of modulated electromagnetic radiation through a solid medium. The term does not imply that the associated devices are coupled by electrically conductive wires.

[00140] Processes:

[00141 ] Unless specifically stated otherwise, as apparent from the following discussions, it is appreciated that throughout the specification discussions utilizing terms such as "processing", "computing", "calculating", "determining", "analysing" or the like, refer to the action and/or processes of a computer or computing system, or similar electronic computing device, that manipulate and/or transform data represented as physical, such as electronic, quantities into other data similarly represented as physical quantities.

[00142] Processor:

[00143] In a similar manner, the term "processor" may refer to any device or portion of a device that processes electronic data, e.g., from registers and/or memory to transform that electronic data into other electronic data that, e.g., may be stored in registers and/or memory. A "computer" or a "computing device" or a "computing machine" or a "computing platform" may include one or more processors.

[00144] The methodologies described herein are, in one embodiment, performable by one or more processors that accept computer-readable (also called machine- readable) code containing a set of instructions that when executed by one or more of the processors carry out at least one of the methods described herein. Any processor capable of executing a set of instructions (sequential or otherwise) that specify actions to be taken are included. Thus, one example is a typical processing system that includes one or more processors. The processing system further may include a memory subsystem including main RAM and/or a static RAM, and/or ROM.

[00145] Computer-Readable Medium:

[00146] Furthermore, a computer-readable carrier medium may form, or be included in a computer alert parameter product. A computer alert parameter product can be stored on a computer usable carrier medium, the computer alert parameter product comprising a computer readable alert parameter means for causing a processor to perform a method as described herein.

[00147] Networked or Multiple Processors:

[00148] In alternative embodiments, the one or more processors operate as a standalone device or may be connected, e.g., networked to other processor(s), in a networked deployment, the one or more processors may operate in the capacity of a server or a machine in server- network environment, or as a peer machine in a peer- to-peer or distributed network environment. The one or more processors may form a web appliance, a network router, switch or bridge, or any machine capable of executing a set of instructions (sequential or otherwise) that specify actions to be taken by that machine.

[00149] Note that while some diagram(s) only show(s) a single processor and a single memory that carries the computer-readable code, those in the art will understand that many of the components described above are included, but not explicitly shown or described in order not to obscure the inventive aspect. For example, while only a single machine is illustrated, the term "machine" shall also be taken to include any collection of machines that individually or jointly execute a set (or multiple sets) of instructions to perform any one or more of the methodologies discussed herein.

[00150] Additional Embodiments:

[00151 ] Thus, one embodiment of each of the methods described herein is in the form of a computer-readable carrier medium carrying a set of instructions, e.g., a computer alert parameter that are for execution on one or more processors. Thus, as will be appreciated by those skilled in the art, embodiments of the present invention may be embodied as a method, an apparatus such as a special purpose apparatus, an apparatus such as a data processing system, or a computer-readable carrier medium. The computer-readable carrier medium carries computer readable code including a set of instructions that when executed on one or more processors cause a processor or processors to implement a method. Accordingly, aspects of the present invention may take the form of a method, an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Furthermore, the present invention may take the form of carrier medium (e.g., a computer alert parameter product on a computer-readable storage medium) carrying computer-readable alert parameter code embodied in the medium.

[00152] Carrier Medium:

[00153] The software may further be transmitted or received over a network via a network interface device. While the carrier medium is shown in an example embodiment to be a single medium, the term "carrier medium" should be taken to include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more sets of instructions. The term "carrier medium" shall also be taken to include any medium that is capable of storing, encoding or carrying a set of instructions for execution by one or more of the processors and that cause the one or more processors to perform any one or more of the methodologies of the present invention. A carrier medium may take many forms, including but not limited to, non-volatile media, volatile media, and transmission media. [00154] Implementation:

[00155] It will be understood that the steps of methods discussed are performed in one embodiment by an appropriate processor (or processors) of a processing (i.e., computer) system executing instructions (computer-readable code) stored in storage. It will also be understood that the invention is not limited to any particular implementation or alert parameter technique and that the invention may be implemented using any appropriate techniques for implementing the functionality described herein. The invention is not limited to any particular alert parameter language or operating system.

[00156] Means For Carrying out a Method or Function

[00157] Furthermore, some of the embodiments are described herein as a method or combination of elements of a method that can be implemented by a processor of a processor device, computer system, or by other means of carrying out the function. Thus, a processor with the necessary instructions for carrying out such a method or element of a method forms a means for carrying out the method or element of a method. Furthermore, an element described herein of an apparatus embodiment is an example of a means for carrying out the function performed by the element for the purpose of carrying out the invention.

[00158] Connected

[00159] Similarly, it is to be noticed that the term connected, when used in the claims, should not be interpreted as being limitative to direct connections only. Thus, the scope of the expression a device A connected to a device B should not be limited to devices or systems wherein an output of device A is directly connected to an input of device B. It means that there exists a path between an output of A and an input of B which may be a path including other devices or means. "Connected" may mean that two or more elements are either in direct physical or electrical contact, or that two or more elements are not in direct contact with each other but yet still co-operate or interact with each other. [00160] Embodiments:

[00161 ] Reference throughout this specification to "one embodiment" or "an embodiment" means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases "in one embodiment" or "in an embodiment" in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments.

[00162] Similarly it should be appreciated that in the above description of example embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the Detailed Description of Specific Embodiments are hereby expressly incorporated into this Detailed Description of Specific Embodiments, with each claim standing on its own as a separate embodiment of this invention.

[00163] Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

[00164] Different Instances of Objects

[00165] As used herein, unless otherwise specified the use of the ordinal adjectives "first", "second", "third", etc., to describe a common object, merely indicate that different instances of like objects are being referred to, and are not intended to imply that the objects so described must be in a given sequence, either temporally, spatially, in ranking, or in any other manner. [00166] Specific Details

[00167] In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practiced without these specific details. In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

[00168] Terminology

[00169] In describing the preferred embodiment of the invention illustrated in the drawings, specific terminology will be resorted to for the sake of clarity. However, the invention is not intended to be limited to the specific terms so selected, and it is to be understood that each specific term includes all technical equivalents which operate in a similar manner to accomplish a similar technical purpose. Terms such as "forward", "rearward", "radially", "peripherally", "upwardly", "downwardly", and the like are used as words of convenience to provide reference points and are not to be construed as limiting terms.

[00170] Comprising and Including

[00171 ] In the claims which follow and in the preceding description of the invention, except where the context requires otherwise due to express language or necessary implication, the word "comprise" or variations such as "comprises" or "comprising" are used in an inclusive sense, i.e. to specify the presence of the stated features but not to preclude the presence or addition of further features in various embodiments of the invention.

[00172] Any one of the terms: including or which includes or that includes as used herein is also an open term that also means including at least the elements/features that follow the term, but not excluding others. Thus, "including' is synonymous with and means "comprising". [00173] Scope of Invention

[00174] Thus, while there has been described what are believed to be the preferred embodiments of the invention, those skilled in the art will recognize that other and further modifications may be made thereto without departing from the spirit of the invention, and it is intended to claim all such changes and modifications as fall within the scope of the invention. For example, any formulas given above are merely representative of procedures that may be used. Functionality may be added or deleted from the block diagrams and operations may be interchanged among functional blocks. Steps may be added or deleted to methods described within the scope of the present invention.

[00175] Although the invention has been described with reference to specific examples, it will be appreciated by those skilled in the art that the invention may be embodied in many other forms.

Industrial Applicability

[00176] It is apparent from the above, that the arrangements described are applicable to the medical and anaesthetic monitoring industries.

Claims

Claims The claims defining the invention are as follows:

1 . A system for monitoring the physiology of a patient, comprising: a patient monitor configured to: collect one or more monitored variables of the patient; display clinical information relating to the patient based on the one or more monitored variables; provide at least one alert in response to a pre-determined parameter, whereby the alert is generated when one or more of the monitored variables matches a programmed trigger threshold value; and transmit data via an output means connected to a communication network, the data being any one or more of the collected one or more monitored variables, the clinical information and the at least one alert;

a remote processing apparatus, in communication with the patient monitor via the communications network, and configured to: receive the transmitted data from the patient monitor; connect with one or more databases containing information of the patient under anaesthetic and actual and/or theoretical information of other patients; retrieve the information from the one or more databases; compare the retrieved information with the transmitted data; and transmit the compared data and information via a second output means connected to the communication network, thereby generating modified alert parameters;

and a mobile processor configured to:

display at least part of the clinical information; and

provide the at least one alert and/or the modified alert.

2. A system for monitoring the physiology of a patient according to claim 1 , wherein the mobile processor is further configured to receive one or more commands from a user, which are transmitted via the communication network to one or both of the remote processing apparatus and the patient monitor.

3. A system for monitoring the physiology of a patient according to claim 2, wherein the one or more commands include user defined modification of the alert parameter.

4. A system for monitoring the physiology of a patient according to claim 3, wherein the user defined modification of the alert parameter assigns a patient identifier to the modified alert parameter, which is unique to the patient.

5. A system for monitoring the physiology of a patient according to claim 4, wherein the user defined modification of the alert parameter assigns one or more patient classifiers to the modified alert parameter, each patient classifier being relevant to a particular classification of the patient under anaesthetic and that is also a relevant particular classification to other patients.

6. A system for monitoring the physiology of a patient according to claim 5, wherein the unique patient identifier and patient classifier are transmitted via the communication network to the remote processing apparatus and are stored in one or more databases connected thereto.

7. A system for monitoring the physiology of a patient according to claim 5, wherein the compared data and information is based only upon the patient under anaesthetic as identified by the patient identifier.

8. A system for monitoring the physiology of a patient according to claim 5, wherein the compared data and information is based upon both the patient under anaesthetic and other patients in the relevant classification to the patient as identified by one or more of the patient classifiers.

9. A system for monitoring the physiology of a patient according to claim 1 , wherein the alert parameter includes assessment based on particular patient data obtained in real time when the parameter is set-up.

10. A system for monitoring the physiology of a patient according to claim 9, wherein the alert parameter includes assessment based on particular patient data obtained historically.

1 1 . A system for monitoring the physiology of a patient according to claim 9, wherein the alert parameter includes assessment based on other medically similar particular patient data obtained from other medically similar patients.

12. A system for monitoring the physiology of a patient according to claim 1 , wherein the information in the one or more databases includes real individual user data, or real multiple individual user data, or statistically acceptable theoretical or conglomerated data that follows a theoretical hypothesis accepted by peer review scientific analysis, a range of actual and theoretical data to determine advisory alerts and data representations for use by a medical professional for anaesthetic monitoring of the patient.

13. A system for monitoring the physiology of a patient according to claim 12, wherein the information can be updated from a range of locations and over a range of time.

14. A system for monitoring the physiology of a patient according to claim 12, wherein the information of the patient under anaesthetic and actual and/or theoretical information of other patients includes medical patient information from operations performed in the past in one or more locations, including medical procedure type, medical procedure site and other patient parameters.

15. A system for monitoring the physiology of a patient according to claim 14, wherein the information includes one or more of patient descriptive data, user preference data, anesthetists data and patient physiological data.

16. A system for monitoring the physiology of a patient according to claim 1 , wherein the remote processing apparatus processes patient information, big data analytics and advisory alerts.

17. A system for monitoring the physiology of a patient according to claim 1 , wherein the mobile processor is one or more of a tablet computing device, a smart phone, a heads up display unit or a telecommunication device.

18. A system for monitoring the physiology of a patient according to claim 1 , wherein the physiology relates to anaesthetic monitoring and the monitored variables comprises one or more of the following heart rate, blood pressure invasive (if present) and noninvasive, Sp02, ETCo2, BIS/Entropy if present, ET Anaesthetic Agents, and User- determined physiological Data.

19. A system for monitoring the physiology of a patient according to claim 1 , wherein the alert includes a visual data representation in the form of a graph of one or more of the monitored variables.

20. A system for monitoring the physiology of a patient, comprising: a patient monitor configured to: a. access a database of usual alert parameters for a patient being monitored; b. select a first one of a plurality of alert parameters for the patient; c. determine the first alert parameter for the patient with particular data related to the patient; and d. transmit the first alert parameter as determined via a communications network, e. collect monitored variables of the patient and transmit the collected monitored variables via a communications network; a remote processing apparatus in communications with the patient monitor via the communications network and configured to: i. receive the first alert parameter from the patient monitor via the communications network; ii. receive the collected monitored variables from the patient monitor via the communications network; iii. connect with a database; iv. process the first alert parameter to compare the monitored variables of the patient from the measuring device per the command and monitored data relating to the patient and/or relating to other patients; v. transmit said compared data via the communications network or an alert signal to generate an alert based on the collected monitored variables of the patient approaching the first alert parameter as determined from the compared data; and an alert device in communications with the remote processing apparatus via a communications network and configured to: a) receive the compared data relating to the patient via the communications network; and/or b) receive an alert signal to generate an alert based on the collected monitored variables of the patient approaching the first alert parameter as determined from the compared data.

. A method for monitoring the physiology of a patient, the method comprising the steps of a. assigning a first one of a plurality of alert parameters to the patient using a patient monitor, wherein the first alert parameter includes a command for collecting monitored data relating to the monitored variables of the patient; b. transmitting particular data relating to the patient from a monitor to the patient monitor via a communications network; c. customizing the first alert parameter to the patient with the particular data related to the patient; d. transmitting the first alert parameter as determined from the patient monitor to a remote processing apparatus via the communications network; e. executing the first alert parameter in the remote processing apparatus to receive the monitored data from a measuring device per the command; f. transmitting the monitored data from the remote processing apparatus to the patient monitor via the communications network; g. storing the monitored data in a database accessible to the patient monitor; h. receiving an alert signal wherein the alert signal is: ii. generated based on the monitored data and iii. available at the monitor for review by a medical practitioner; b) generating a modified alert based on said monitored data.