EP3762945A1

EP3762945A1 - Self-diagnostic system

Info

Publication number: EP3762945A1
Application number: EP19712044.7A
Authority: EP
Inventors: Fabio PASQUALI
Original assignee: Wantong S A; Wantong SA
Current assignee: Wealty SA
Priority date: 2018-03-06
Filing date: 2019-03-01
Publication date: 2021-01-13
Also published as: WO2019171229A1; IT201800003318A1

Abstract

System (100) for monitoring and direct diagnosis of the pertinent parameters for the health of a person provided with a box (1) and a door (10) for the entrance of the user in the box (1), said box (1) comprising a reclinable chair (2) on which the user sits in an operative position to perform the monitoring and direct diagnosis of the pertinent parameters, a software platform (3) to interface with the user and at least an instrument housing (4) for accommodating a plurality of electro-medical self-analysis and therapeutic instruments. The instrument housing (4, 4 ', 4' ', 4' '', 41) is positioned near the user in such a way that the user utilizes the plurality of electro-medical instruments contained in said instrument housing without having to modify and its operating position on the reclinable chair (2) inside the system (100) and without the help of local health personnel.

Description

SELF-DIAGNOSTIC SYSTEM

DESCRIPTION

Technical field of the invention

The present invention relates to an innovative system for self-diagnosis, that is for monitoring the parameters of interest for the health of an individual, without the help of local health personnel. This system allows patients of all ages to be able to conduct their own check-up in complete autonomy.

Background art

As is known and in extreme synthesis, the definition of telemedicine adopted by the World Health Organization (WHO) in 1997 is: "telemedicine is the provision of health services, when distance is a critical factor, for which it is necessary to use, by the operators, information and telecommunication technologies in order to exchange information useful for the diagnosis, treatment and prevention of diseases and to guarantee continuous information to healthcare providers and support research and evaluation of therapy”.

Telemedicine systems are generally based on the use of:

• a computer that allows the communication of all electro-medical instruments and the collection of data from the acquisition of biomedical signals that is connected to the Internet to allow data to be sent to another location;

• a system composed of hardware and software parts that allow, in synergy, the acquisition, saving and sending of the collected data by a biomedical signal.

The presence of a computer allows to easily interface the instrumentation present inside the telemedicine system through input/output such as USB, serial port, parallel port, Bluetooth, Infrared etc. The complexity of the medical device itself is thus reduced, which will no longer need to be equipped with the hardware useful for displaying the parameters and mechanisms allowing network connection, processing and possible manipulation of the acquired signals. This offers the possibility to store data on an internal or external database, reachable via internet connection and already be connected to the network without having to develop auxiliary interfaces for the device.

Also known are systems that use telemedicine which include a "gateway" device whose purpose is to collect information from the medical devices that detect the biomedical signals coming from the individual who is carrying out the analysis. The same "gateway" allows not only the reading and the local saving of data, but also the sending of data to a database stored in external servers.

However, self-diagnosis systems are not known for completely autonomous use by the user, user-friendly for any individual and able to detect an extremely high number of medical parameters.

There is therefore a need for a compact and manageable system complete with all medical detection instruments, medical self-analysis and therapeutic instruments used both in health and aesthetic, as well as a cutting-edge software and hardware that can monitor the parameters of interest to the health of an individual. A system therefore able to provide telemedicine, self-analysis and therapeutic services.

Summary of the invention

The object of the present invention is therefore an innovative system for self- diagnosis, that is, for monitoring the parameters of interest to the health of an individual without the help of local health personnel. This system includes an innovative management software platform that allows to the individual who is carrying out the analysis to monitor countless parameters such as, for example, weight, height, BMI, blood pressure, heart rate, airway patency, blood glucose, blood tests, etc. These analysis performed directly by the individual are allowed by an ergonomic positioning of the electromedical instrumentation, easily reachable by the user as it is located in specific housings positioned near the chair on which the user sits. The system could also provide remote medical assistance, with a specialist doctor, on the prevention of diseases such as diabetes and cardiovascular disease.

The data generated by the medical devices connected to the self-diagnosis system are acquired by a software platform, online and offline, and local hardware and are transferred "server-side" via the Internet, wireless connection or data connection, without taking any action on data themselves, to the doctor specialist for reporting or to the electronic medical record for archiving.

The self-diagnosis system is specified in the annexed independent claim.

The dependent claims outline particular and further advantageous aspects of the invention.

Brief description of the drawings

These and other advantages of the invention will now be described in detail, with reference to the accompanying drawings, which represent an exemplary embodiment of the invention, in which:

- Figures 1 , 1 'and 2 show an embodiment of the system according to the present invention, in a closed-structure configuration;

- Figure 2 'in a partial axonometric view of the system according to the present invention;

- Figure 3 shows a side section view of the system, according to the present invention;

- Figure 4 shows a plan view of the system, according to the present invention;

- Figure 5 is a table of the laminations of the materials used for the realization of the system according to the present invention, - Figure 6 shows the positioning of the instruments within the system, according to an embodiment of the present invention,

- Figure 7 in a partial axonometric view, shows the positioning of the instruments with respect to a user in the position of use of the system, according to an embodiment of the present invention.

Detailed description

With reference to the attached figures, a system 100 is shown comprising a box 1 shown in a preferred configuration with a closed structure and destined for the environments set up/dedicated to accommodate this system, guaranteeing privacy. This system 100, thanks to its extreme compactness and lightness, can be positioned both in outdoor and indoor environments. In particular, the box 1 comprises a door 10 through which the user can enter, a reclinable chair 2 with automated movement, used as a workstation for the provision of monitoring services of the parameters of interest, a software platform 3, a local hardware interfacing with the user and one or more instrument housings 4 (shown in Figures 2-4) for containing the electromedical instrumentation.

Box 1 is made of composite materials, extremely light and resistant to weather conditions. As listed in the table in Figure 5, box 1 is made up of its opaque parts, i.e. walls, floor and roof and with composite material (gelcoat - glass fabrics laminated in the molds): after the lamination and extraction of the molds these are treated with "post curing" technique, in order to make styrene and styrene compatible with human contact. The materials are all fireproof, homologated to guarantee class 1 fire protection.

The box 1 , in particular, includes an external body that creates a closed and separated from the outside. At the height of about 90 cm around the perimeter are inserted opaque polycarbonates that shield to the outside and provide greater privacy without making it a claustrophobic space for those who are inside. The outer skin is spaced with a gap of about 3 cm from the inner body (against printed) of box 1 , also it is made of composite material and has multiple functions: a) covering all the unfinished parts of the external mold;

b) guarantee a perfectly smooth, finished and treated surface with a gelcoat that is fire, abrasion and acid resistant, in order to be hygienized by workers with specific products;

c) protect the cables of the electrical system that connect all the electro-medical equipment in order not to cause damage to the user;

d) accept all the compartments and supports necessary to receive / store all equipment (electro-medical equipment, lighting spotlights, emergency lights, switches, sockets, electrical panels, air extractor).

Moreover, the box 1 is provided with four steel and rubber wheels suitably designed to support the load of both the empty box and two people inside it. The wheels allow the 100 system to be conveniently moved inside the spaces where it is located.

The 100 system includes electromedical self-analysis and therapeutic instruments of class I and class II, connected via USB or Bluetooth, for the direct diagnosis, control and therapy of the main physical and clinical parameters of the user who can detect them autonomously.

All data / parameters generated by the medical devices connected to the 100 system are acquired by the software platform 3, online and offline, and by a local hardware and are transferred server-side, without any action on the data themselves, to the medical specialist for the reporting or to the electronic medical record for archiving.

Specifically, the software application allows one or more of the following operating steps: - enter the input data of the patient or user by swiping the health card or any document with a unique patient code via magnetic strip reader 9 (figure 6 or 7) or by voice command;

- digitally sign for the collection of informed consent according to the regulations in force concerning the protection of personal data;

- receive from medical devices (via USB or Bluetooth depending on the communication mode of the device), through software plug-in, the data processed by the same once the measurement has been performed;

- transfer the encrypted and structured data according to the XML schema to the Server where they are stored;

- show on video (obtaining from the server) the results obtained from electromedical equipment and server-side transfers;

- save the vital parameters in the electronic medical record, to which the patient can access at any time and on any hardware through their credentials received via e-mail;

- receive a consultation or report of the examination carried out by remote connection with a specialist doctor (telemedicine service);

- synchronize the data acquired from the various electro-medical devices with those acquired from any electronic device external to the Box and not connected to it.

Advantageously, the software platform 3 is provided with a graphical interface for controlling the software through the use of specific keys displayed on the graphical interface itself and is provided with an application to allow the telemedicine operator to acquire data and interact with the user.

The method for remote monitoring of the health conditions of a patient or user and for real-time audiovisual assistance, including the following steps: • connect the software platform 3 with a Windows operating system and application software to the electromedical instruments for measuring the biometric parameters of the user;

• provided with the data acquired through the software platform 3

• send the processed data to a server via an internet connection, to store them in a special database, to be viewed by a remote telemedicine operator using a computer connected to the database.

In particular, the 100 system with the management software platform 3 allows one or more of the following steps:

• collecting the data recorded by the user and process them "securely";

• performing a synchronous high-definition video communication with the doctor;

• organizing data and processes in a simple and rational way by adhering to the standards of clinical engineering (in the field of teleconsultation and / or tele visit);

• interfacing departmental systems according to "XDS profiles" or according to the standard format for sharing documents in the healthcare environment;

• interfacing "PACS" systems (from the English picture archiving and communication system) through the "DICOM" standard (from the English Digital Imaging and Communications in Medicine), digital images and communication in medicine;

• communicating "ECG" tracks in line with the "DICOM-ECG" standard;

• managing the process of dematerialization and substitute legal archiving according to current regulations;

• carrying out synchronous and asynchronous distance collaboration;

• carrying out communication and asynchronous messaging;

• performing user profiling;

• broadcasting information differentiated according to profiles. The system 100 is also able to interface any equipment that exposes its data (in the case of audio and images, even in analog form).

In the example shown in figure 6, box 1 includes inside a led monitor 5, a reader for digital signature 6, a software platform 3, a compartment for USB connections 7, a compartment for electricity connections 220V 8, a reader magnetic strip health card 9, a capillary instrument 21 , an instrument for otorino 22, a tool for dermatologist 12, a trichological instrument 13, a tool for controlling body temperature 14, a cardiac instrument 15, an instrument for controlling blood pressure 16, blood analysis instrument 17, an instrument for blood glucose control 18, an airway patency control instrument 19, a special waste compartment 20 and a body weight control tool 21 .

Specifically, the electromedical self-analysis and therapeutic instruments of class I and class II, contained within box 1 and in rooms 4 are, by way of example: a sphygmomanometer, a diagnostic scale, a pulse oximeter, a thermometer, a dermatoscope, an otoscope, a capillaroscope, a trichoscope, an electrocardiograph, a spirometer, a blood glucose meter, instruments for blood tests, instruments for auditory tests and visual tests and a tool for aesthetic treatments.

Advantageously, for greater ergonomics and ease of use, in the example shown in Figure 7, the electromedical instruments to be easily reachable and conveniently usable by the user, they are positioned in specific housings near the reclinable chair 2 on which the user sits. For example, the dermatoscope, the otoscope, the capillaroscope and the tricoscope, made up of digital microscopes, are positioned specifically in a housing 4' indicated on the right of the user to allow correct functionality, i.e. a correct positioning of these instruments on the body of the user and a correct acquisition of photos or videos. Likewise, the electrocardiograph, the blood glucose meter and the spirometer are positioned specifically in a 4" housing to the right of the user and the instruments for blood tests and auditory tests are placed specifically in a 4"’ housing always to the right of the user. The diagnostic scale is positioned at floor level 40, so that the user only has to get on it and wait for the result. The sphygmomanometer is positioned in a housing 41 to the right of the user with the possibility of inserting only the left arm in the cuff of the aforementioned device. The instrumentation for aesthetic treatments, i.e. a mat with magnetic coils positioned on the chair to allow the regeneration of cellular tissues and for analgesic effect.

According to an embodiment of the present invention, the system 100 is configured to be used by the user through the interactive delivery of questionnaires / tests with multiple-answer questions and / or numerical answers. The questionnaires can also be used through the use of a simple infrared remote control.

Advantageously, the management software platform integrates a high-quality video communication system, that is, an acquisition matrix from SQCIF (from the English Sub-Quarter Common Intermediate Format) to high definition self-adapting variable bit-rate compression and a "Presence Server" online user manager that allows defining groups of users, i.e. it prevents everyone from calling everyone. In particular, the video communication system is particularly efficient: it does not require broadband to operate, on the contrary it requires a guaranteed minimum continuous flow of 40 kbps (comparable to a 3G key with low coverage - a basic DSL line is more than sufficient).

The video communication system is also particularly effective and easy to use because it does not require the configuration of network devices to connect the personal computers belonging to different subnets (transversal compliant). This system is also of the "MS Windows based" type and is available on workstations, on all-in-one touch screens, on tablets, and in the "Instant Messenger" version that can be installed on any personal computer.

Advantageously, the user interface is user-friendly and totally customizable upon request and there is a web front-end for managing the service, defining and configuring user profiles, user levels, consulting data acquired through biomedical, environmental, video sensors. - rooms, etc.

Advantageously, the software platform is made "server-side" with "cloud" logic in a mixed environment in which the primary front-end is in Microsoft environment. The modularity of the management software platform makes it possible to create vertical solutions in an extremely competitive way while maintaining full compliance with the standards of communication and interoperability.

Advantageously, the data sent are stateless or streaming, for example XML over HTTP or IP streaming. Any type of data, numerical, binary or event can be treated, that is stored or conveyed in a workflow (e.g. treatment of events):

• clinical data: both data collected at home or from departments such as PACS, CIS, RIS, LIS or standard protocols for diagnostic image databases in cardiology, radiology, etc .;

• environmental data coming from sensors: temperature, humidity, etc .;

• events signaled by sensors: for example motion detectors.

Advantageously, the contexts of the teleconsultation activities connect to the departmental systems (personal data, RIS, CIS, LIS, REGISTRY and REPOSITORY also XDS) according to standard HL7 profiles (where present). The use of the DICOM protocol guarantees interoperability in the field of diagnostic images (PACS), while DICOM-ECG is the format used for the transfer of ECG traces in tele-cardiology contexts.

Advantageously, the system is configured with digital signature (256 bit signature support) interoperable and compatible with the main Italian and non-Italian certification bodies.

Advantageously, the management software platform is equipped with a multi protocol gateway for interfacing different networks, with data normalization to the central system: interfacing with medical sensors (certified "medical device") via Bluetooth and sensor compatibility according to the ZigBee standards , 433 MHz, Bluetooth, Xbee, Infrared, Usb, Rs232.

In addition to the embodiment of the invention, as described above, it is to be understood that numerous further variants exist. It must also be understood that such embodiments are only exemplary and limit neither the scope of the invention, nor its applications, nor its possible configurations. On the contrary, although the above description makes it possible for the skilled technician to implement the present invention at least according to an exemplary embodiment thereof, it must be understood that many variations of the described components are conceivable, without thereby departing from the scope of the invention, as defined in the attached claims, which are interpreted literally and/or according to their legal equivalents.

Claims

1 . System (100) for monitoring and direct diagnosis of the pertinent parameters for the health of a person comprising a box (1 ) and a door (10) for the entrance of the user in the box (1 ), said box (1 ) comprising a reclinable chair (2) on which the user sits in an operative position to perform the monitoring and direct diagnosis of the pertinent parameters, a software platform (3) to interface with the user and at least an instrument housing (4) for accommodating a plurality of electro-medical self- analysis and therapeutic instruments, said system (100) being characterized in that said at least one instrument housing (4, 4 ', 4' ', 4' ", 41 ) is positioned near the user in such a way that the user utilizes the plurality of electro-medical instruments contained in said instrument housing without having to modify and its operating position on the reclinable chair (2) inside the system (100) and without the help of local health personnel.

2. System (100) according to claim 1 , wherein said box (1 ) comprises an external body made of plexiglass and fiberglass.

3. System (100) according to claim 1 or 2, wherein said box (1 ) comprises an inner body made of composite material suitable for covering the electrical system which connects all the electro-medical instruments.

4. System (100) according to any of the claims from 1 to 3, wherein said box (1 ) is provided with rolling means (5) positioned in the lower part of the box (1 , 1 1 ) to make the box movable.

5. System (100) according to any of the claims from 1 to 4, wherein said software platform (3) allows one or more of the following operations:

- entering user data manually, using a magnetic strip reader or voice command;

- digitally signing for the collection of informed consent;

- receiving medical data from the medical equipment once the measurement has been performed;

- transferring the encrypted and structured data to a server; - showing the results obtained from electro-medical devices on video;

- saving the vital parameters in the electronic medical record;

- receiving a consultation or referral to the examination by a specialist doctor.

6. System (100) according to any of the claims from 1 to 5, configured to allow one or more of the following operations:

- collecting the data recorded by the user;

- performing a high definition synchronous video communication with the doctor;

- organizing data and processes in a simple and rational way by adhering to the standards of clinical engineering;

- interfacing departmental systems according to "XDS profiles";

- interfacing "PACS" systems through the "DICOM" standard;

- communicating ECG tracks in line with the "DICOM-ECG" standard;

- managing the process of dematerialization and substitute legal archiving according to current regulations;

- carrying out synchronous and asynchronous distance collaboration;

- carrying out communication and asynchronous messaging;

- performing user profiling;

- broadcasting information differentiated according to profiles.

7. System (100) according to any of the claims from 1 to 6, wherein said electro medical instruments comprise, a sphygmomanometer, a diagnostic scale, a pulse oximeter, a thermometer, a dermatoscope, an otoscope, a capillaroscope, a trichoscope, an electrocardiograph, a spirometer, a blood glucose meter, blood analysis instruments, instruments for auditory tests and visual tests, and an instrument for beauty treatments.