Monitoring of medical conditions
Contents
1. and a summary of patient data which may be relevant such as medication history 0104 Inarea 31 there is shown a summary of event types and the scores left blank in the example for each event type across three separate sleep sessions 0105 In area 32 there is displayed a series of report clauses which provide a basic analysis in medical lan guage of the analysed data and provide some guidance to the doctor with regard to both the final diagnosis and the type of corrective action that may be taken to alleviate the disease 0106 The user interface on the computing device pre sents the report on screen and offers a printed version or a file to copy or save The report can be explained directly the patient or can be printed out and sent to the patient or to the patient in any suitable manner such as via email 0107 As the sleep related breathing disorder monitoring device is used with successive patients the predetermined number of medical tests allowed by the encrypted key is decreased As the sleep related breathing disorder monitor ing device approaches a state of inoperability due to the performance of the predetermined number of sleep related breathing disorder monitoring tests the software applica tion residing on the doctor s computing device prompts the doctor to perform a number of tasks 0108 The doctor is prompted to log into the central server via a website generate an invoice for the key u2. within the sleep related breathing disorder device 0073 The analysis software routines examine the breath sequence data collected by the sleep related breathing dis order device The analysis software routines utilise an algo rithm that extracts information regarding the frequency and context of certain breath categories The algorithm performs an analysis of the collected data on the basis of a predeter mined series of investigations For example if a breathing disorder such as a cessation of breath during a breath cycle is detected in a single breath cycle the algorithm determines the frequency and the distribution of the cessation of breath over the period of the cycle This process is repeated for each breath cycle captured in the data set 0074 Once the analysis software routines have processed the entire data set a series of summary statistics describing each variable of interest is produced The summary statistics include how many breaths included an apnoea and other parameters related to the existence of sleep related breathing disorders and the distribution of each type of breath over the total time of the recording 0075 The summary statistics are represented and described in a report that is provided in a format which is understandable to a doctor That is the report is written in medical language rather than merely providing numerical data This translation of raw data to medical language is achieved through t
3. 31 the method further comprising the step of in response to a request from the medical professional the service provider re enabling the medical device to allow a further predetermined number of medical tests to be carried out 33 A method in accordance with claim 32 wherein the request from the medical professional includes the step of providing payment to the service provider in return for re enabling the medical device 34 A computer program arranged when loaded on a computing system to implement a method in accordance with claim 31 35 A computer readable medium providing a computer program in accordance with claim 34 36 canceled
4. accessible to patients 0005 Furthermore patients are generally inconve nienced when they are required to undergo such an extensive and intrusive examination A patient is required to be away from home for a full night and to sleep in a non natural environment The patient may also incur additional cost through the need to visit a specialist for referral and follow up on several occasions Travel costs and a potentially negative impact on work and recreation time adds to a detrimental effect on the patient 0006 Therefore there has been a trend in recent years to develop simpler less expensive triage or screening and diagnostic devices that focus on very few parameters and in some cases a single parameter These devices have been developed in an attempt to provide opportunities for home based assessment of patients However these devices remain quite expensive in terms of capital cost even though they are less expensive than the equipment required for a complete sleep laboratory 0007 Patients may still have to travel to a central location to be given instructions on how to use the device or technicians may have to travel to a patient s home There fore the current devices remain relatively complex and technical failure particularly with children can be high when patients do not follow instructions correctly Due to these drawbacks doctors are generally reluctant to use and promote such devices SUMMARY OF THE INVENT
5. received key and if both keys match the device and or the software application will be rendered operable 0083 In some situations both the computing device and the sleep related breathing disorder device may require complimentary encrypted keys in order to operate as a safety measure 0084 In the present embodiment accounting and stock control functions are initiated by the central server based on individual payment plans and the periodic requirement to purchase an encrypted key although it will be understood that other methodologies may be developed which allow the delivery of the encrypted key and such methodologies are within the scope of the present invention 0085 Furthermore it will be understood that the encrypted key could be implemented in a number of man ners For example each encrypted key may only allow one medical test to be performed such that a plurality of encrypted keys would be downloaded into either the medical device and or the computing system to allow a plurality of medical tests to be performed That is if the doctor wanted to perform five medical tests he would download five encrypted keys Alternatively the encrypted key could US 2007 0118397 Al include information pertaining to the number of medical tests which may be performed so that a doctor may purchase one encrypted key which is valid for a number of medical tests 0086 The central server is also capable of retrieving summary data f
6. value which corresponds to the number of times the any one of the medical device or the computing system may be used before being rendered inoperable 0038 The encrypted key may contain the unique serial number wherein the device will only be rendered operable if the unique serial number contained in the encrypted key matches the unique serial number contained in the medical device 0039 Ina fourth aspect the present invention provides a system for the provision of a medical test including a medical device in accordance with the first aspect of the present invention and a computing device in accordance with the second aspect of the present invention 0040 The system may further include a computing sys tem in accordance with the third aspect of the present invention 0041 Ina fifth aspect the present invention provides a method of providing a medical service comprising the steps of 0042 a service provider providing access to a system in accordance with the fourth aspect of the invention to a medical professional May 24 2007 0043 the service provider enabling operation of an p g op y one of the medical device and the computing system for performing a predetermined number of medical tests 0044 wherein once the predetermined number of medical tests have been carried out the any one of the medical device and the computing system is rendered inoperable 0045 The method may further comprise the step of i
7. ION 0008 In a first aspect the present invention provides a device for use in the provision of a medical test the device comprising May 24 2007 0009 a testing means arranged to perform the medical test and 0010 control means arranged to disable the device from performing the medical test once a predetermined number of tests have been performed 0011 The device may further include storage means arranged to store control data for determining the predeter mined number of medical tests that the device is able to perform 0012 The device may further comprise communication means to enable upload of control data to the device whereby the device can be enabled to perform a further predetermined number of tests 0013 The control data may include an encrypted key 0014 The medical device may further comprise a unique serial number 0015 The medical device may be an air flow monitoring device for use in a sleep apnoea and or sleep related breath ing disorder test In this embodiment the testing means includes 0016 respiratory sensing means arranged to sense a respiratory signal the respiratory sensing means being arranged to communicate with a respiratory tract of a patient and 0017 memory means arranged to receive and store the respiratory signal 0018 The respiratory sensing means may be a pressure transducer and the memory means may be flash memory 0019 The respiratory sensing means may
8. US 20070118397A1 as United States a2 Patent Application Publication co Pub No US 2007 0118397 A1 Williams et al 43 Pub Date May 24 2007 54 MONITORING OF MEDICAL CONDITIONS 30 Foreign Application Priority Data 76 Inventors Anthony Williams Tintenbar AU May 14 2003 AU eee eeeeeseeseeseeeereenees 2003902308 Ronald Grunstein Bellevue Hill AU f Gunnar Unger Kingsgrove AU Publication Classification Correspondence Address 51 Int Cl LADAS amp PARRY LLP G06Q 10 00 2006 01 224 SOUTH MICHIGAN AVENUE A6IB 5 00 2006 01 SUITE 1600 92 LUS Cle wh rset act ant tithes ou 705 2 600 300 CHICAGO IL 60604 US 21 Appl No 10 556 736 57 ABSTRACT 22 PCT Filed May 14 2004 C2 te ia The present invention provides a medical device 13 and an 86 PCT No PCT AU04 00609 associated computing system 12 for performing a medical test a predetermined number of times before a control 371 c 1 means disables the test device and subsequent analyses of 2 4 Date Feb 8 2006 the test Patient Data e Name ID e Gender e Age from DOB BMI from Height weight e Epworth X 24 Snore history X 5 a Hypertension CV e Medication for consideration 31 Sleep Recording Data Session 1 Session 2 Total Number No Session Hour Total Number No Session Hour Suggested diagnosis and suggestion Recorded data is based on a
9. al reference material The central server generates the encrypted key to the computing device which may then be retrieved by the doctor when the doctor logs into the central server 0080 Each encrypted key may be used as a means of allowing data analysis to occur on the doctor s computing device in addition to or in place of requiring an analysis key to operate the sleep related breathing disorder device This provides a variety of methods for allowing the central server to monitor and charge a fee for service provision 0081 It will be understood that the encrypted key may be obtained in any suitable format For example the encrypted key may be directly downloaded from the central server into the computing system or the sleep related breather disorder monitoring device Alternatively the key may be provided in an email or on a webpage and the doctor may subsequently manually enter the key into the software application to allow analysis to proceed 0082 In one embodiment the key is an alphanumeric string of data which is serialised That is the central server generates the key based on the serial number contained in the sleep related breathing disorder monitoring device for the software application Once this key is entered or down loaded into the software application or the medical device the software or medical device uses the same algorithm to generate an expected key The expected key is then compared to the
10. ans arranged to sense a respiratory signal the respiratory sensing means being arranged in use to communicate with a respiratory tract and memory means arranged to receive and store the respira tory signal May 24 2007 8 A device in accordance with claim 7 wherein the respiratory sensing means is a pressure transducer 9 A device in accordance with claim 7 wherein the memory means is flash memory 10 A device in accordance with claim 7 wherein the respiratory sensing means is in fluid communication with a nasal cannula 11 A device in accordance with claim 7 wherein the device further includes a data transfer means 12 A device in accordance with claim 11 wherein the data transfer means is compatible with the Universal Serial Bus standard 13 A device in accordance with claim 1 further including a display arranged to display information relating to the operation of the device 14 canceled 15 canceled 16 A computing device for use in the provision of a medical test comprising means for acquiring medical test information from a medical device means arranged to analyse the medial test information and means arranged to disable the computing device for performing the analysis once a predetermined number of analyses have been performed 17 A device in accordance with claim 16 further com prising means for receiving control data from an external source the control data enabling the computing devic
11. be in fluid communication with a nasal cannula 0020 The device may further include a data transfer means which in this embodiment is compatible with the Universal Serial Bus standard 0021 In an embodiment including the air flow monitor ing device the nasal cannula may be provided with a coating which is arranged to allow detection of interference with the nasal cannula 0022 The nasal cannula may further comprise an absor bent pad arranged adjacent to an end portion of the nasal cannula wherein in use the absorbent pad traps cellular matter released by the patient 0023 Ina second aspect the present invention provides a computing device for use in the provision of a medical test comprising 0024 means for acquiring medical test information from a medical device 0025 means arranged to analy se the medical test infor 8 mation and 0026 means arranged to disable the computing device from performing the analysis once a predetermined number of analyses have been performed 0027 The computing device may further comprise means for receiving control data from an external source the control data enabling the computing device to perform a further predetermined number of analyses US 2007 0118397 Al 0028 The control data may be received from a central server located on a computer network 0029 The computing device may further comprises means for uploading control data to the computing device wherein t
12. cation is capable of providing all the standard administrative functions neces sary for the successful operation of the sleep related breath ing disorder device It will be understood however that the central requirement of the software application will be to analyse data retrieved from the sleep apnoea monitoring device and any other functions herein described are advan US 2007 0118397 Al tageous but not essential to the software application Fur thermore such administrative functions whilst incorporated in the same software application in the embodiment described herein may in other embodiments be a separate software application or a series of stand alone or interrelated software applications 0071 The core of the software application comprises analysis software routines arranged to analyse respiratory signals provided by the sleep related breathing disorder monitoring device and categorise each breath of a patient according to its shape height and frequency characteristics Primarily the analysis software routines seek to determine whether there is an isolation within a breath 0072 Inthe embodiment described the analysis software routines are incorporated within the software application which resides on the computing device However it will be understood that the analysis software routines may in other embodiments be provided in a number of different arrange ments such as on a remote server or embedded in hardware
13. continue to use the sleep related breathing disorder monitoring device 13 the doctor must retrieve a new encrypted key from the central server 10 to the computing device 12 The encrypted key may subse quently be keyed into the computing device 12 to the sleep related breathing disorder monitoring device 13 at which time the sleep related breathing disorder monitoring device 13 becomes functional 0068 The computing device in the present embodiment includes a software application The software application may be provided to and or installed on the computer by any suitable method such as via the Internet or on a CD ROM 0069 The software application has a number of func tions which may include but are not limited to enabling a doctor to set up the sleep related breathing disorder moni toring device for a new patient testing the sleep related breathing disorder monitoring device to ensure that the sleep related breathing disorder monitoring device is operating correctly retrieving patient data from the sleep related breathing disorder monitoring device storing patient data and printing records connecting directly with the central server which is generally located at a remote location monitoring disposable stock requirements and payment plan options viewing account status generating tax invoices for payment and communicating either directly or indirectly with technical and clinical support 0070 That is the software appli
14. ctly to the pressure trans ducer with a secure locking mechanism Preferably the length of the nasal cannular tubing is approximately 2 m 0089 In operation the embodiment of the present inven tion allows a doctor to access diagnostic medical equipment at a reduced cost At a first stage in the process a doctor accesses a website to purchase or hire a sleep related breathing disorder monitoring device It will be understood that the sleep related breathing disorder device may be sold as a single unit in multiple quantities or as part of a kit the kit containing other related items such as instruction manu als spare parts disposable cannulas computer software or any other item which may be related to the satisfactory operation of the device It will be appreciated that the device or kit may be purchased in any other suitable way For example the device or kit may be purchased over the telephone by faxing an order form to an appropriate retailer or by purchasing over the counter 0090 In the preferred embodiment of the present inven tion the kit includes a customised software application that is downloaded and installed onto the doctor s computing device The kit may also comprise a user manual a modified generally inoperative demonstration sleep related breath ing disorder monitoring device instructional literature and disposable cannula stock 0091 It will be appreciated that the components of the kit may b
15. device and a simple demonstration in relation to the positioning of the nasal cannular and the operation of the said device The sleep related breathing disorder monitoring device is then connected via a USB Universal Serial Bus connection to the computing device and patient details are entered into the database provided by the software application A battery and device check is conducted by the computing device Then the said device new cannula brief questionnaire and instruction packaging is given to the patient to take home 0095 At home the patient is able to review the instruc tions and practice fitting the cannula Upon retiring for the evening on the designated night the patient fits the cannula and connects it to the said device as directed The testing process is initiated by the patient activating a switch on the device Once the sleep related breathing disorder monitoring device is initiated the said device collects data regarding the patients breathing pattern ie air flow in and out of the nostrils of the patient as measured by the pressure trans ducer for a period of eight hours The data collected is stored in the flash memory The sleep related breathing disorder monitoring device is arranged to stop automatically The patient is instructed to wear the said device for the entire night and removes the device upon awakening in the morn ing The device may have sufficient memory to allow for recording the breathing patter
16. displaying evidence of tampering US 2007 0118397 Al 0119 The sampling of nasal cells via the cannula also provides further opportunities for health risk assessment Using nasal squamous cell samples provides other opportu nities to detect the progress of sleep disordered breathing the risk of developing cardiovascular disease other likeli hood of a certain treatment outcomes following say a pharmaceutical treatment or similar 0120 Whilst an embodiment of the present invention has been described with reference to a sleep related breathing disorder test it will be understood that an embodiment of the present invention may be employed with any type of medi cal test and or any type of medical device and in particular to any type of medical test that requires the collection of a large sample of data over a defined period of time such as an ECG electrocardiogram or heart signal monitoring test or a temperature monitoring test ie monitoring body tem perature to determine ovulation time 0121 Furthermore it will be understood that the com puting system described in the present specification may be provided via the use of any appropriate hardware or soft ware and elements of an embodiment of the present inven tion may correspondingly be provided by any appropriate computing hardware or software applications 0122 In the description above reference is made to a doctor However it will be understood that any suitable
17. e to perform a further predetermined number of analyses 18 A device in accordance with claim 17 wherein the control data may be received from a central server located on a computer network 19 A device in accordance with claim 18 further com prising means for uploading control data to the medical device wherein the uploading of control data enables the medical device to perform a predetermined number of medical tests 20 A device in accordance with claim 16 wherein the medical device is a device in accordance with claim 1 21 A device in accordance with claim 16 wherein the medical test information is a respiratory signal 22 A device in accordance with claim 16 wherein the means for analysing the respiratory signal determines the presence of an apnoea pattern 23 A device in accordance with claim 22 wherein the means further correlates the apnoea pattern to a diagnosis 24 A device in accordance with claim 22 wherein the means for analysing the respiratory signal may be in the form of a software application 25 A computing system for use in the provision of medical services the computing system being arranged to communicate remotely with any one of a medical device or a computing system comprising means for identifying the any one of the medical device or the computing system and means to enable the upload of control data to the any one of the medical device or the computing system whereby the any one of the med
18. e varied as is required for specific circumstances 0092 The doctor may purchase the kit on a suitable payment plan This allows the doctor to acquire the kit without incurring any substantial initial cost In one embodi May 24 2007 ment the cost of single kit is covered by approximately ten service episodes after which the doctor would own the kit outright However it is noted that the doctor could choose to pay for the kit up front That is the doctor may purchase lease or otherwise obtain an embodiment of the present invention by any suitable method in accordance with local marketing strategies economic practices and legal consid erations 0093 When a doctor purchases a kit or medical device the doctor is assigned a unique ID number and account number Larger practices may also be assigned a practice ID number In one embodiment details relating to the number of kits purchased payment plans service records stock purchase and account status will be located in a customised database structure located within the software application that is installed on the doctor s computing device The details are mirrored on the central server and updated each time the computing device communicates with the central server 0094 In use in a consultation a doctor may decide that the application of a sleep test is necessary If this is the case the doctor will provide a patient with a sleep related breath ing disorder monitoring
19. etrieved from the nasal cannula with requested DNA samples from the screening candidate The nares section of the cannula is cut from the tubing and stored in a suitable freezer until testing is required If testing is deemed neces sary a sample of tissue or fluid from the screening candidate or an existing certified profile is compared with nasal cell samples retrieved from the nares that have been removed from the cannula The DNA profile may be obtained from the cells by any suitable method such as polymerase chain reaction PCR analysis Such a feature creates a deterrent for the screening candidate to manipulate the testing proce dure 0118 Further steps can also be taken to ensure the screening system is not subject to abuse and fraud To ensure that the screening client does not seek a surrogate candidate and subsequently clean and reuse the cannula to deposit a legitimate DNA sample on the nares of the cannula the nares can be stamped with a generic non toxic stable chemical footprint to allow identification of any tampering through the disturbance or absence of the said footprint Another possibility to prevent tampering is to add a com fort pad made of material that absorbs cell samples such as felt or gauze to the nares so that samples can be taken in a manner which precludes easy tampering since the cellular matter containing DNA is absorbed into the fibres of the pad which is difficult to clean without
20. g the associated capital cost inherent in purchasing and maintaining expensive medi cal equipment 0054 This advantage is achieved in part by providing a system including a medical device which collects patient data and an associated computing system which analyses the data The system counts the number of times a medical test has been performed When a predetermined value is reached the system is rendered inoperable to prevent unau thorised use of the medical device The system may be rendered inoperable by either disabling the medical device thereby preventing the collection of further data or by disabling the computing system thereby preventing the analysis of further collected data This allows a manufac turer or supplier of the system to provide eg lease the medical device to a doctor for a nominal value but requires the doctor to pay a fee for each use of the device 0055 The system is preferably rendered operable by the introduction of an encrypted key The encrypted key in one embodiment may be downloaded to the medical device from a central server via a computing device located in a doctor s surgery In another embodiment the encrypted key US 2007 0118397 Al may be downloaded or manually keyed into the computing system It will be understood that the encrypted key is a preferable feature and in other embodiments the medical device may be rendered operable by resetting a digital counter or by any othe
21. he uploading of control data enables the computing device to perform a predetermined number of analyses 0030 The medical device may be a device in accordance with the first aspect of the invention and the medical test information may be a respiratory signal 0031 The means for analysing the medical test informa tion may analyse the respiratory signal to determine the presence of an apnoea pattern and may further correlate the apnoea pattern to a diagnosis 0032 The means for analysing the respiratory signal may be in the form of a software application 0033 Ina third aspect the present invention provides a computing system for use in the provision of medical services the computing system being arranged to commu nicate remotely with any one of a medical device or a computing system and comprising 0034 means for identifying the any one of the medical device or the computing system and 0035 means to enable the upload of control data to any one of the medical device or the computing system whereby the any one of the medical device or the computing system can be enabled to perform a prede termined number of medical tests or analyses 0036 The means for identifying the medical device is a code reading means arranged to read a unique code embed ded in the medical device and the unique code may be a serial number 0037 The control data may include an encrypted key wherein the encrypted key contains a numerical
22. he use of standard report clauses The report clauses are chosen from a list of possible report clauses which are pre programmed into the analysis soft ware That is a series of standard scenarios are included in a database The database uses predetermined rules to select specific report clauses depending on the summary statistics provided by the analysis software routines 0076 For example if a first variable say a frequency characteristic falls within a certain range of values a specific report clause will be selected and printed As there are limited report clauses available when diagnosing sleep related breathing disorders all possible combinations of results for each variable are mapped to each of the report clauses available 0077 The system may also incorporate a facility to allow the summary statistics to be forwarded to a specialist medi May 24 2007 cal professional or the doctor may provide the report to a specialist medical professional for verification or further analysis 0078 The system further includes a central server that resides at a location remote from the personal computer and the sleep related breathing disorder monitoring device although it will be understood that the central server may in some embodiments reside in the same area as the computing system 0079 The central server mirrors the analysis and data base software provided on the computing device and may also host a library of clinic
23. ical device or the computing system can be enabled to perform a prede termined number of medical tests or analyses US 2007 0118397 Al 26 A system in accordance with claim 25 wherein the means for identifying any one of the medical device or the computing system is a code reading means arranged to read a unique code embedded in the any one of the medical device or the computing system 27 A system in accordance with claim 26 wherein the unique code is a serial number 28 A system in accordance with claim 25 wherein the control data uploaded to the medical device from the com puting system is an encrypted key wherein the encrypted key contains a numerical value which equals the number of times the medical device may be used before the device is rendered inoperable 29 A system in accordance with claim 28 wherein the encrypted key contains the unique serial number and the device will only be rendered operable if the unique serial number contained in the encrypted key matches the unique serial number contained in the medical device 30 canceled 31 A method of providing a medical service comprising the steps of a service provider providing access to a system in accor dance with claim 25 to a medical professional May 24 2007 the service provider enabling operation of any one of the medical device and the computing system for perform ing a predetermined number of medical tests 32 A method in accordance with claim
24. king patient history and or snoring sleepiness data US 2007 0118397 Al MONITORING OF MEDICAL CONDITIONS FIELD OF THE INVENTION 0001 The present invention relates to a method and system for providing a medical test and specifically but not exclusively to a method and system for providing a sleep related breathing disorder test BACKGROUND OF THE INVENTION 0002 The diagnosis of many medical diseases and dis orders generally involves a complex and lengthy study of the affected patient involving many hours of a physicians time and expertise in addition to a large amount of expensive specialised and sophisticated diagnostic equipment 0003 For example in diagnosing sleep related breathing disorders one method of diagnosis involves a formal sleep study in a sleep laboratory after referral from a sleep physician Such an investigation would usually occur in a hospital or private laboratory environment Sleep studies are generally complex and expensive because they seek to measure a number of different parameters simultaneously A parameter will be understood to encompass any measur able statistic such as for example a patient s heart rate blood pressure breathing pattern or brain activity 0004 Moreover in many countries such as Australia sleep physicians must be sufficiently credentialled to request such a service Therefore such formal sleep studies are expensive time consuming and not easily
25. medical professional health care professional or other per son may operate or interact with an embodiment of the present invention including a nurse or a patient 0123 Modifications and variations as would be apparent to a skilled addressee are deemed to be within the scope of the present invention 1 A device for use in the provision of a medical test the device comprising a testing means arranged to perform the medical test and control means arranged to disable the device from per forming the medical test once a predetermined number of tests have been performed 2 A device in accordance with claim 1 further including storage means arranged to store control data for determining the predetermined number of medical tests that the device is able to perform 3 A device in accordance with claim 2 the device further comprising communication means to enable upload of con trol data to the device whereby the device can be enabled to perform a further predetermined number of tests 4 A device in accordance with claim 1 wherein the control data is an encrypted key 5 A device in accordance with claim 1 wherein the medical device further comprises a unique serial number 6 A device in accordance with claim 1 wherein the medical device is an air flow monitoring device for use in a sleep apnoea and or breathing disorder test 7 A device in accordance with claim 1 wherein the testing means includes respiratory sensing me
26. n response to a request from the medical professional the service provider re enabling the any one of the medical device and the computing system to allow a further prede termined number of medical tests to be carried out 0046 The request from the medical professional may include the further step of providing payment to the service provider in return for re enabling the any one of the medical device and the computing system 0047 Ina sixth aspect the present invention provides a computer program arranged when loaded on a computing system to implement a method in accordance with a fifth aspect of the present invention 0048 Ina seventh aspect the present invention provides a computer readable medium providing a computer program in accordance with a sixth aspect of the invention 0049 Ina eighth aspect the present invention provides a device for use in the provision of a medical test to a test patient the device comprising 0050 a testing means arranged to perform a medical test 0051 control means arranged to disable the device from performing a medical test once a predetermined number of tests have been performed and 0052 means for obtaining a DNA sample from the test patient during performance of the medical test 0053 Ina preferred embodiment the present invention advantageously provides a system by which a medical professional such as a doctor may provide a medical service to clients without incurrin
27. n of a patient or other param eters for a number of nights 0096 The patient subsequently returns the sleep related breathing disorder monitoring device to the doctor and the said device is connected to the doctor s computing device The data stored in the flash memory is downloaded and analysed by the analysis software The analysis software analyses the breath cycles data collected by the sleep related breathing disorder monitoring device and identifies the total number and duration of atypical patterns in the breath cycle including 0097 Apnoeas total cessation of breath within a cycle 0098 Hypoapneas smaller amplitude breaths 0099 Flow limitations US 2007 0118397 Al 0100 Oscillation snoring 0101 Artefacts tloss of signal leaks etc 0102 The analysis output is coded and stored on the doctor s computing device in a customised database format Report clause options from a library of standard report clauses are retrieved from within the database structure The report clauses the selection of which are based on the results of data analysis and selected summary statistics are presented via a pre determined report which is assembled by the software based on the summary statistics An example report is shown in FIG 3 0103 In area 30 there is shown personal patient data including name date of birth the patient s body mass index BMI plus a short analysis of the patient s historical scores
28. ntral server via a web site interface and may download an encrypted key directly to the sleep related breathing disorder monitoring device without the need for the software appli cation Alternatively the sleep related breathing disorder monitoring device may have a built in redundancy wherein the said device is permanently rendered inoperable when the predetermined number of medical tests are per formed In this case the medical professional is required to purchase a new sleep related breathing disorder monitoring device rather than downloading a fresh encrypted key 0115 In an alternate embodiment the sleep related breathing disorder monitoring device further incorporates an identity checking means arranged to ascertain the identity of a user This allows the sleep related breathing disorder monitoring device to be utilised in situations where estab lishing the identity of the user is important 0116 For example there may be situations where screen ing for sleep related breathing disorders is deemed manda tory in order to fulfil licensing conditions for example it may become mandatory for truck drivers to take sleep apnoea tests In such situations it is important to ensure that the candidate who requires testing ie the screening candi date is in fact the same person who self administers the test 0117 An embodiment of the present invention tests the nasal cannula for a DNA profile and matches the DNA profile r
29. on of an embodiment thereof by way of example only with refer ence to the accompanying diagrams in which 0061 FIG 1 is a schematic diagram of a system in accordance with an embodiment of the present invention 0062 FIG 2 is a schematic block diagram illustrating componentry of a sleep related breathing disorder monitor ing device in accordance with an embodiment of the present invention and 0063 FIG 3 is a sample report produced by the analysis software in accordance with an embodiment of the present invention DETAILED DESCRIPTION OF A SPECIFIC EMBODIMENT 0064 In a preferred embodiment the present invention comprises a system including a computing device arranged to interact with a central server and a medical device arranged to interact with the computing device Together the computing device the central server and the medical device form a system for facilitating provision of medical tests in one embodiment being a sleep related breathing disorder test to patients 0065 In FIG 1 there is shown a schematic diagram depicting one embodiment of the present invention A cen tral server 10 is connected to an appropriate network 11 such as the Internet A doctor accesses the central server via May 24 2007 the network 11 from a computing device 12 In the embodi ment in accordance with the present invention the comput ing device 12 is a personal computing device but the computing device may be any appr
30. opriate device such as a personal digital assistant or a proprietary computing device arranged to interact solely with the central server 10 and a medical device 13 In the embodiment herein described the medical device 13 is a sleep related breathing disorder monitoring device The device collects data regarding a patient s breathing pattern ie air flow in and out of the nostrils of the patient However it will be understood that any suitable parameter data may be attached such as a pH reading ie for monitoring gastric reflux a heart rate signal for monitoring possible heart arrhythmia or an eyelid signal for vigilance testing The sleep related breathing disorder device 13 may be attached to the computing device 12 either via a cradle 14 or directly via a USB connection 15 The sleep related breathing disorder monitoring device 13 contains flash memory 16 a portion of which houses an encrypted key 17 0066 Before the sleep related breathing disorder moni toring device 13 is used by a patient the encrypted key 17 is modified in flash memory 16 in order to render the device operable When a predetermined number of medical tests have been carried out by the sleep related breathing disorder device 13 the encrypted key 17 is modified deleted or otherwise rendered useless in a manner such that the sleep related breathing disorder monitoring device 13 is tempo rarily rendered inoperative 0067 If the doctor wishes to
31. r suitable means 0056 The encrypted key is created by the central server and may use as an input during creation a unique serial number which is contained in each medical device or in each computing device This serial number is provided in a suitable readable format The serial number is used as a seed to generate the encrypted key 0057 In one embodiment when a doctor wishes to perform a medical test using the medical device the medical device is connected to the doctor s computing device The serial number located in the medical device is communi cated to the central server in an encrypted format The central server generates an encrypted key the encrypted key including information about the medical device ie the serial number of the medical device The encrypted key is then uploaded into the device which allows the device to perform a predetermined number of medical tests 0058 In an alternate embodiment the computing device rather than the medical device may be rendered inoperable when analysis of a predetermined number of data sets has been performed 0059 The encrypted key would be downloaded or keyed into the computing device to render the software application operable and the medical device would be capable of performing an unlimited number of medical tests DETAILED DESCRIPTION OF THE DRAWINGS 0060 Features and advantages of the present invention will become apparent from the following descripti
32. rom the doctor s computing device when the encrypted key is purchased ie when a doctor is logged into the central server 0087 At FIG 2 there is shown a block diagram illus trating the components of the sleep related breathing disor der monitoring device As described above the sleep related breathing disorder monitoring device is comprised of an USB interface 20 which is designed to communicate with a computer 21 The sleep related breathing disorder monitor ing device also comprises a suitable air intake device 22 which in this embodiment takes the form of a disposable cannula Air flow entering the cannula is measured by a pressure transducer 23 to produce an analog signal The analog signal is converted by a micro processor 24 to a digital format which is then capable of storage in flash memory 25 The encrypted key is also stored in flash memory 25 Flash memory is used to retain data as it is non volatile and capable of information storage without a power requirement There is also provided a power source 26 which in the present embodiment takes the form of a rechargeable battery It is also noted that the device may incorporate a visual display unit and necessary controls such that a user may operate the unit not shown 0088 The nasal cannula in this preferred embodiment is a disposable nasal cannula to be used in conjunction with the sleep related breathing disorder monitoring device The nasal cannula is connected dire
33. sed to date receive an additional key if needed confirm a stan dard order of disposable units ie nasal cannula and confirm default delivery arrangements 0109 The result of these transactions is then added to the account status of the doctor 0110 Moreover when the doctor is connected to the central server the central server is able to harvest summary information in a de identified format and other device performance statistics 0111 This allows the central server operator to perform random quality control testing without the need for specific input from the doctor or the need for the devices to be returned or inspected 0112 It will be understood that any appropriate industry standard security measures may be adopted to create the encrypted key or any other sensitive data which is trans ferred to or from the device or to or from the doctor s May 24 2007 computing device to the central server Moreover in the present embodiment data is de identified and no personal patient details are transferred over a public network 0113 It will be understood that while an embodiment of the present invention communicates via a network such as the Internet and uses the software application located on the doctor s personal computing device to interact with the central server any suitable client server architecture may be employed to implement the invention 0114 For example the doctor may log in directly to a ce
34. single channe and indirect information on sleep and sleepiness It s advised that the clinician thoroughly checks data quality and ascertains the complete Clinical history Most likely diagnosis ONo O Moderate O Severe sleep disordered breathing C Patient history and or snoring sleepiness data suggest that expanded sleep investigation should be undertaken O No specific suggestion can be made due to lacking patient history and or snoring sleepiness data Patent Application Publication May 24 2007 Sheet 1 of 2 US 2007 0118397 A1 COMPUTING SYSTEM Patent Application Publication May 24 2007 Sheet 2 of 2 US 2007 0118397 A1 30 Patient Data e Name ID o Gender e Age from DOB BMI from Height weight e Epworth X 24 e Snore history X 5 e Hypertension CV e Medication for consideration Sleep Recording Data Sessioni _Session2 Sessiona rr Seema AE rae mes EY eras eas Seed ieee O S S S S E ea eee E Poor Signal i Suggested diagnosis and suggestion Recorded data is based on a single channel and indirect information on sleep and sleepiness It s advised that the clinician thoroughly checks data quality and ascertains the complete Clinical history Most likely diagnosis O No O Moderate O Severe sleep disordered breathing C Patient history and or snoring sleepiness data suggest that expanded sleep investigation should be undertaken D No specific suggestion can be made due to lac
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