ITMI20111713A1 - SYSTEM AND METHOD TO ACQUIRE IN EITHER REMOTE ECG DATA AND / OR OTHER MEASURES OF LIFE OR CLINICAL PARAMETERS OF PATIENTS - Google Patents

Description

DESCRIPTION

Field of application

In its broadest sense, the present invention relates to a system and a method for remotely acquiring ECG data and / or other measurements of vital or clinical parameters of patients suffering from chronic pathologies or to be kept under strict control.

The invention relates in particular, but not exclusively, to a system of equipment equipped with application programs to effectively but remotely acquire patient ECG data.

The invention also relates to a method of remote acquisition of ECG data and / or other measurements of vital or clinical parameters of patients using the equipment of the aforementioned system.

Known art

As is well known in this specific technical sector, conventional ECG apparatuses are known which are normally used in diagnostic centers to monitor the electrical activity of a patient's heart in order to check its proper functioning.

These devices detect electrical impulses generated by the heart at each beat by means of a plurality of sensors or electrodes connected by means of suction cup or adhesive terminations to the patient's chest and individually located at the end of multiple connection cables coming out of the ECG device.

The electrical signals thus detected are processed by the ECG device in order to be transformed into significant information presented in the form of one or more traces, one or more graphs, numerical information on the characteristics of the complexes that can be displayed or printed to be interpreted by medical personnel.

All known systems have the common drawback of being of particular bulk and size that they are not suitable for domestic use or outside diagnostic centers.

In recent years, the miniaturization of electronic equipment has made it possible to produce ECG devices of a substantially portable type, since they can be powered by batteries and can be housed in a bag or suitcase, such as the commercially known models such as MAC 400 and MAC 800. of GE. However, even these particular types of ECG devices must be used by specialized personnel and are normally supplied to medical or paramedical personnel who physically go to the home of a patient to undergo ECG control.

It should also be noted that this type of portable device incorporates a display and / or a printer to allow specialized personnel to visually appreciate the plot or graph of the acquired data.

Although advantageous under various aspects, these devices can therefore only be used by specialized personnel and are not suitable for personal or domestic use by a patient without assistance.

Other types of portable ECG apparatus are also known which have a more simplified structure and which even allow the data collected to be transmitted via a telephone connection, for example by radio frequency, as described in international patent application No. WO 2011/094399.

However, these latest generation devices have a limitation due precisely to the complexity of their use by unskilled personnel or in any case not previously trained in their use. Therefore, they are not suitable for domestic use by the patient himself or a family member.

Moreover, although advantageous under various aspects, and substantially corresponding to the purpose, the systems offered by the known art do not allow to manage in an integrated way the results of the diagnoses carried out on the basis of the ECG data collected.

The technical problem underlying the present invention is that of devising a system and a relative method for remotely acquiring ECG data, and / or other measurements of vital or clinical parameters of patients, and transmitting said data and measurements and a center diagnostic and reporting, the system and the method having respective architectural and functional characteristics such as to guarantee an easy use by the same patient.

Another purpose of the invention is to allow the creation of a low cost service based on the system and method of the invention that allows to improve the quality of life by keeping under control the conditions of heart health and not only of patients suffering from potential risk of illness or already carriers of pathologies, without forcing the patients themselves to travel to go to specialized facilities.

A further purpose that the invention proposes is to make available the ECG examination, both basal and dynamic (Holter), from any place, including the personal home, without the need for the presence on-site specialized personnel.

Another purpose of the invention is to allow the integrated management of the diagnostic results carried out on the ECG data and / or on the measurements of the clinical parameters collected remotely.

Summary of the Invention

The solution idea underlying the present invention is to create a low-cost system and method that have the same quality of the equipment and services offered in a high-end hospital setting and that can allow you to interact with a telematic portal dedicated to remote diagnosis. In this way, a tool is made available to users / patients that allows them to send their data from anywhere to be reported to qualified doctors, and, at the same time, it allows doctors to remotely analyze the data and consult the medical history of the patient (previous examination reports) to draw up the reports and update the related medical records at any time, as well as facilitating the delivery of the report to the patient.

The widespread diffusion of a service made possible by the system and method of the present invention would also make it possible to reduce access to public health facilities for routine checks, allowing a more targeted use of the same and a reduction in costs for the community.

On the basis of this solution idea, the technical problem is solved by a system for remotely acquiring ECG data and / or other measurements of vital or clinical parameters of patients and transmitting said data and measurements and a diagnostic and reporting center, characterized by made to understand:

a portable medical device powered by batteries and incorporating at least an A / D converter and a memory for temporarily storing ECG data and / or measurements of the patient's vital or clinical parameters;

a remote computer installed at said diagnostic center and containing electronic files referring to each user / patient;

an application program installed in a personal computer supplied to the user / patient to automatically transfer said ECG data and / or said measurements from said memory to the remote computer of a qualified doctor or said diagnostic center;

an application program installed in the computer of the qualified doctor or of said diagnostic center to collect said ECG data and / or said measurements, as well as to make diagnoses on the basis of said ECG data and measurements to be associated with the electronic records referring to the relative users / patients.

Advantageously, the portable medical device comprises an ECG data acquisition device having a connection port for a quick-fit ECG cable and a further port for at least one probe for measuring at least one of said vital or clinical parameters.

Furthermore, the portable medical device comprises a motherboard and a secondary or daughter card interconnected by means of respective board-to-board connectors and an FPC cable. The secondary card is structured and specialized for the acquisition of electrocardiographic signals by means of an Analog Front-End (AFE) type component that detects differential measurements on several amplifiable channels with independent and programmable gain and programmable sampling frequency.

It should also be noted that the electrocardiographic signals are filtered by an ESD protection circuit block also designed to provide output protection to protect the patient from possible sink and source currents.

Furthermore, the aforesaid memory is actually a bank of non-volatile memory units comprising at least one Flash memory and at least one micro IC-card that can be inserted and removed in a relative seat of the device.

The invention also relates to a method for remotely acquiring ECG data and / or other measurements of vital or clinical parameters of patients and transmitting said data and measurements and a diagnostic and reporting center, characterized by the following phases:

- acquiring said ECG data and / or measurements of the patient's vital or clinical parameters by means of a portable medical device powered by batteries and incorporating at least an A / D converter and a memory;

- subsequently transferring said ECG data and / or said measurements from said memory to a remote computer of the diagnostic center by means of an application program installed on a personal computer supplied to the user / patient;

- remotely carry out a diagnosis phase on said ECG data and / or said measurements and associate the results of said diagnosis phase to an electronic file referring to said user / patient by means of an application program installed in the computer of said diagnostic center and the doctor;

- make this electronic file available to the same user / patient to consult the results of the diagnosis.

Advantageously, the transfer of said ECG data and / or said measurements between the portable medical device and the personal computer supplied to the user / patient takes place automatically with wireless transmission mode, or by means of a quick coupling connection, under the supervision of said application program on the user / patient side.

Further characteristics and advantages of the system and of the method of the present invention will emerge from the description, given below, of respective embodiment examples given by way of non-limiting example with reference to the attached drawings.

Brief description of the figures

- figure 1 shows a schematic view of a system made according to the invention to remotely acquire ECG data and / or other measurements of vital or clinical parameters of patients;

Figure 2 shows a schematic view of a detail of the system of Figure 1;

Figure 3 shows a schematic view which illustrates the implementation of the method of the present invention by means of the system of Figure 1;

Figure 4 shows a schematic block view of a component of the system of Figure 1;

- figure 5 shows a perspective view of a portable medical device incorporated in the system for remotely acquiring ECG data according to the invention;

Figures 6 and 6A show respective schematic views of a quick-coupling ECG cable, to be connected to the portable medical device of Figure 5, and of a detail of this cable;

figure 7 shows a schematic side view of the portable medical device of figure 5;

figure 8 shows a schematic block view of the electronic components incorporated in the portable medical device of figure 5;

figure 9 shows a schematic view of greater detail of the internal structure of the medical device of figure 5;

figure 10 shows a schematic view of a detail of the electronic components incorporated in the medical device of figure 5;

- figure 11 shows a further schematic block view of a further part of the components incorporated in the medical device of figure 5.

Figure 12 shows a functional block view of an application program installed in a computer of the system of the present invention;

Figure 13 shows a functional block view of another application program installed in a separate computer of the system of the present invention;

Figure 14 shows a schematic view of the medical device of Figure 5 associated with some quick-coupling probes intended for measuring the patient's clinical parameters;

Figures 15 and 16 show respective schematic views of computer networks

Detailed description

With reference to these figures, 1 globally and schematically indicates a system made in accordance with the present invention to remotely acquire ECG data and / or other measurements of vital or clinical parameters of patients 2 to transmit said data and measurements and a diagnostic and / or reporting center schematized with the numeral 4.

For this purpose, the system 1 comprises a portable medical device 3 for acquiring and transmitting said data and measurements to the diagnostic center 4.

The medical device 3 is intended primarily, but not exclusively, for personal use and is therefore aimed at a set of users / patients 2 which includes virtually everyone, including pediatric patients and pacemaker wearers. In addition, the medical device 3 offers the possibility to perform a basal ECG examination as well as a dynamic ECG according to the Holter method. With the help of quick-fit probes it is also possible to measure other physiological parameters relevant for monitoring the health of a patient.

System 1 also includes application programs 5 installed in the medical device 3 and / or in a personal computer supplied by the user / patient 2. Furthermore, system 1 includes application programs 7 installed or supplied by a computer of a qualified doctor or at the same diagnostic and reporting center 4 intended to store patient reports.

The application programs 5 on the user / patient side are dedicated to the configuration of the medical device 3, to the automatic transfer of the ECG data acquired, to their possible storage in the local computer.

Similarly, the application programs 7 of the medical / diagnostic center 4 side are dedicated to the processing, analysis and final reporting of ECG data and the results of their analysis, as well as to the transmission of the reports to the user / patient computer. in the face of a specific request.

System 1 was created with the intention of being used both for outpatient use and for personal and home use, as it is structured to be able to interface via the Internet 6 with a remote diagnosis and reporting service.

System 1 also manages the safe and secure reception of the ECG data to be reported and their storage in a digital archive compliant with the provisions on the processing of sensitive data. The system also provides for a subsequent safe and secure transfer of ECG data to the qualified doctor in charge of reporting, who diagnoses and compiles a report 10 by means of a special application program 7 provided by system 1 according to the invention.

The report 10 is then delivered to user 2 through the same application components 7 and 5 responsible for the telematic transfer of ECG data and storage of the same in the space dedicated to the user intended as an electronic folder referring to it.

Now let's see in more detail the architecture of system 1 according to the invention which includes the following components:

â € ¢ a portable medical device 3 for recording ECG data, equipped with power batteries;

â € ¢ a group of probes / sensors 25 removably connected to the portable medical device 3 by means of a quick-connect ECG cable 15;

â € ¢ an application program 5 dedicated to patients (Patient Client) installed on a personal computer 20 or on a palmtop available to user / patient 2 (or a family member);

· An application program 7 dedicated to doctors (Medical Client) installed on a personal computer 40 or on a PDA available at the qualified doctor's office;

â € ¢ a telematic connection 8 to manage the transmission of data and information via the internet 6 to and from the diagnostic center 4 both by the application programs 5 on the user / patient side and by the application programs 7 on the doctor side .

â € ¢ A web portal 9 for consultation by the user / patient and / or doctor (using a standard browser) of their medical records or for activating various services.

Figure 4 schematically illustrates the portable medical device 3 which is responsible for recording ECG data and / or for measuring the vital or clinical parameters of patients, such as the level of glucose or oxygen in the blood, and which includes essentially:

â € ¢ an acquisition device 11;

â € ¢ an ECG cable 15 with at least ten leads and relative terminations for corresponding disposable ECG electrodes 25.

The acquisition device 11 is a portable device powered by batteries which is mainly concerned with acquiring and storing in an internal memory 35 the ECG signals coming from the electrodes 25 placed on the patient's chest and connected to the device 11 itself by means of the cable 15. The device 11 is structured to transfer the data stored in the memory 35 to a computer 20, or equivalent device (palmtop, notebook or whatever) through a communication port 23, USB, or by means of a wireless technology such as Bluetooth Low Energy technology. (BLE).

Figure 6 A schematically shows in enlarged scale the conformation of the connector 17 which allows to connect the ECG cable 15 to the acquisition device 11.

The device 1 1 can also be used as a host platform to host a plurality of plug-in measurement sensors with which it can interact through the USB port 23, or through the BLE wireless technology, or even through the HDMI port normally used for connecting the ECC 15 cable. In this way the device 11 acquires the ability to measure vital or clinical parameters of patients 2, as well as other physiological parameters depending on the type of sensor connected in plug-in mode. For example, it is easy to equip the 1 1 acquisition device with blood glucose or oxygen level sensors as well as other types of sensors that include a probe that can return an electrical signal related to the measurement to be made.

As shown in the example of figure 4, the device 11 can also be described by analyzing its mechanical, electronic and firmware components.

From the mechanical point of view, the acquisition device 11 is composed of a casing of synthetic-plastic material, for example a shell of polycarbonate or ABS, or a mixture of both, formed by two parts 12, 13 joined by snap or by screws , as shown in figure 5,

Device 11 can also be equipped with a protective silicone rubber (TPE) shell to protect it from impact.

The front part 12 has a hole 14 for housing a control button and a window 18 dedicated to housing a viewer or display 19.

The rear part 13 integrates a cover, not shown as it is conventional, which gives access to the battery compartment, and a removable clip 66 to allow the device to be anchored to a belt. It should be noted that the acquisition device 11 is shaped with a slight curvature to follow the profile of the human body when it is anchored to the belt.

An upper edge, shown in figure 7, has two distinct recesses 22, 23 to accommodate the end 17 of the ECG cable 15 and of the USB connection cable, not shown as it is conventional.

The two recesses are deliberately adjacent so that the connection of the ECG cable 15, suitably equipped with a right angle connector 17, can obstruct access to the USB port 23; with this we want to avoid that the user / patient performs an ECG with the device 11 mistakenly connected via USB to a host device.

From an electronics point of view, the acquisition device includes a motherboard 21, the so-called Motherboard, which houses all the components suitably bound to the board on the opposite side with respect to the one on which the display frame 19 rests, in order not to have interference mechanical with the display itself.

Board 21 can be considered a â € œgenerai purposeâ € digital platform and includes a microprocessor 50 and a series of functional blocks which will be illustrated below with particular reference to figure 8.

When power is supplied via USB the input signal is filtered by a different LDO regulator which generates a 3.3V output. This output is used both to disable the DC / DC block (to inhibit the power supply line coming from the batteries, if present) and to power the DVDD channel.

Starting from the power supply block 51, it should be noted first that the ignition mechanism of the device 11 may involve different components as there are different ways to make the device turn on, for example:

1) By connection to an external power source via USB port 23 (connection to an external power supply or to a host device)

2) By pressing a button or button 60 for power or Power ON

3) By means of the Wakeup Alarm procedure, previously set by the user

In the first case, ignition is direct and the insertion of a USB connector supplies power to the entire system, which remains powered as long as the USB power source remains active.

In the second case, pressing the Power ON key or button 60 causes a DC / DC regulator or converter to be enabled and consequently the microprocessor 50 is switched on.

Releasing button 60 has the consequence of removing the enable from the DC / DC regulator. To keep the device switched on, the firmware incorporated in the microprocessor intervenes before the release of the button 60 by forcing the enabling line of the DC / DC regulator to be activated.

To avoid switching on due to accidental pressing of the button 60, the firmware implements a mechanism called debouncing which forces the user to keep the Power ON button 60 constantly pressed for an interval of at least two seconds.

In the third case with ignition programming, the enabling line of the DC / DC converter regulator is activated by the wake-up alarm signal coming from a 53 RTCC component. That is, it is possible to make the device 11 switch on automatically at a precise time of a given day previously set by the user.

Also for what concerns the switching off of the device there can be different mechanisms. If the device is powered by USB, it can only be shut down by removing the power source (ie the USB cable or the source that supplies power through the cable).

If the device is powered by batteries, it can be turned off by removing the batteries or by having the firmware of the microprocessor 50, interpreting an explicit request by the user, release the enabling line of the DC / DC regulator. Preferably, the shutdown request has been selected by continuously pressing the Power ON button 60 for at least two seconds.

Also in this case the firmware of the microprocessor 50 implements a debouncing mechanism to filter accidental pushes of the button.

Finally, the Power 51 block, detailed in Fig. 11, supplies power to the various external sensors 67, 68 possibly connected in plug-in mode to the device on the USB port 23 or on the HDMI port 22.

The 5V power supply signal is generated by a second DC / DC regulator having an enabling line connected to the microprocessor and therefore managed directly by the firmware.

The other functional blocks of the digital Motherboard 21 include:

an accelerometer 52, for measuring the acceleration components on the three Cartesian axes;

a block 53 RTCC (Reai Time Clock and Calendar) for date, time, wake-up alarm functions and for storing configuration parameters in an internal and non-volatile memory (block 53 RTCC integrates an EEPROM memory from a few tens of bytes). These parameters also include the serial number and information on the activation status of device 1 1. The serial number is a unique identification number and therefore different from device to device. Thanks to the serial number it is possible to trace the status and history of each device. The status allows you to enable or disable the use of the device itself;

a bank 35 of non-volatile memory units in which the acquired ECG data are stored, or the vital or clinical parameters of the patients 2 measured by means of the electrodes 25 or the plug-in probes. There are two types of memory units: a Flash memory, in the form of a component soldered directly on the motherboard (capacity in the order of MegaBytes, low consumption, high flexibility), and a micro IC-card that can be inserted and removed using a special soldered connector on the motherboard (capacity in the order of GigaBytes, higher consumption, less flexibility);

an RF wireless communication subsystem 55 based on BLE technology, for the transmission and reception of radio frequency data;

a USB module 23 for interfacing with external host devices or with the various plug-in measurement probes, already seen with reference to figure 7;

a user interface block 56, which comprises:

o the 19 LCD color display (262K colors) of at least 2.8â € (resolution 320x240 pixels) equipped with a touch-screen interface and backlighting with adjustable intensity;

o button 60 for switching on and off, which can also be used as a general purpose button once device 11 has been switched on;

o two independent LED indicators 59;

or a buzzer 57 for the reproduction of sound signals.

All the components of the user interface 56 are under the direct control of the firmware of the microprocessor 50, both as regards the input part (button 60 and touch-screen 19), and for the output part (switching on-off of the LEDs 59, visualization of images on the display 19, control of the intensity of the backlighting 58, reproduction of monotonic sounds by means of the buzzer 57).

The microprocessor 50 is preferably 32-bit for the control of all peripherals and data processing.

An interface 54 for interconnection towards a secondary board 31, called daughter board or Daughterboard, is also provided. This interface 54 is based on a seventeen-pin board-to-board connector 61 used to carry an SPI channel, some digital signals and at least two power lines, a DVDD digital line and an AVDD analog line to the secondary card.

The secondary board 31 is shown schematically in Figure 9 and in turn mounts the same type of connector 6 1 board-to-board with seventeen contacts. The interconnection between the two boards is made by means of a special cable 62 of the FPC type.

This type of interconnection mechanism makes the acquisition device 11 as a whole extremely modular and flexible.

In fact, from the point of view of the production process, it is possible to have two separate production and test lines that proceed in parallel, one for the motherboard 21 and another for the daughter card 3 1.

Even in the event of a fault, only the damaged board can be replaced.

Having concentrated the general purpose functions on Motherboard 21, it is possible to specialize the product so that it can implement particular user functions simply by modifying the Daugtherboard alone.

In the specific case of the device described here for indicative and non-limiting purposes, the Daughterboard 31 is structured and specialized for the acquisition of electrocardiographic signals. The acquisition is carried out by means of a 63 AFE (Analog Front-End) component which implements differential measurements on several channels (up to eight) that can be amplified with independent and programmable gain (with a gain factor between 1 and 12), with a frequency of programmable sampling (between 250Hz and 32KHz) and with 24bit ADC resolution.

The combination of these characteristics, added to the characteristics of the power supply signals supplied by the Motherboard 21, means that the resolution of the AFE can reach tenths of a microVolt.

Component 63 AFE acts as an SPI â € œslaveâ € peripheral and communicates with the microprocessor 50 of the CPU of the Motherboard 21 via interface 54 and connector 61 board-to-board. From the same interface 54 it also receives the power supply and other digital control signals. The acquired data are sent via SPI in real time to the microprocessor 50 of the Motherboard 21. Everything is controlled and supervised by the firmware on board the microcontroller 50.

The analog ECG signals to be sampled come from the patient cable 15 which is connected to the Daughterboard 31 via a standard HDMI 22 connector with customized pinout.

Before reaching the AFE component, the signals are filtered by a circuit block 65 which implements the defibrillator protection at the input (ESD discharges) and the protection for the patient (sink and source currents) at the output, all shown schematically in figure 10 .

Returning to the cable 15 and the electrodes 25 of the acquisition device 11, it should be noted that the ten-lead cable is preferably of the custom type and made with the aim of having a small footprint and reduced weight in order to be easily transportable, while maintaining the quality of the signal conveyed by the electrodes to the device. To obtain a reduction in weight and bulk, it was decided to use cables with a reduced diameter for each of the ten branches (about 2.7 mm2 in section and length equal to 80cm).

The terminations for connecting the electrodes are of the button clip type. The connection cable 16, on the other hand, has a diameter of -6.25 mm2 and a length of 40cm. The junction box is of the electro-welded type and has no defibrillator protection inside (the protection is implemented inside the ECG recorder). The box also contains information on how to position the electrodes and all information relating to the traceability of the product. A 22, 17 HOMI connector was preferred to connect the cable to the ECG recorder. The 22, 17 HDMI connector, extremely compact and lightweight, has also made it possible to reduce the size of the ECG recorder. Another peculiarity of the connector 17 is that it has a right angle shape to obstruct access to the USB port 23 of the device 11. This prevents the possibility of carrying out the ECG with the device connected via USB to devices, which could generate electrical discharges potentially dangerous for the patient.

The electrodes 25 are disposable, with a button connection, in compliance with current regulations relevant for electrocardiographs and for the type of patient (for example for pediatric patients).

Now, with particular reference to the examples of figures 12 and 13, the methods for implementing the method of the present invention will be illustrated by means of the application programs 5 and 7 on the user side and on the diagnostic center side, respectively.

As mentioned above, user / patient 2 must have a personal computer, or any other equivalent host device (palmtop, smartphone, tablet), in order to install an application program 5 that allows you to activate a remote diagnosis and reporting service. This application program 5 can be broken down into functional blocks as shown in figure 12

A user interface 27 allows the patient 2 to access in a simple and intuitive way the functions of the application program 5, or to perform all those operations which involve the portable medical device 3 on the one hand and the remote diagnosis and reporting service on the other. made possible by the present invention.

More specifically, the following operational phases are envisaged: â € ¢ User authentication at start-up;

â € ¢ Connection to device 3;

· Device configuration 3;

â € ¢ Device 3 diagnostics, with any on-board firmware update;

â € ¢ View the status of the ECG data (or other data) present on the device 3;

Transfer of ECG (or other) data from device 3; â € ¢ Connection to the remote diagnosis and reporting service, intended as a remote application program, and relative authentication;

â € ¢ Sending new ECG data (or other data and measurements) to the remote diagnosis and reporting service to be analyzed;

â € ¢ Consultation of the processing status of the ECG data (or other measurements) sent;

â € ¢ Transfer of report 10 from the remote diagnosis and reporting service when available;

· Visualization of the history of ECG exams (or other measurements) already performed;

â € ¢ Sending to the Service of clinical data and pre-existing reports to be filed in the electronic clinical file associated with the given patient;

â € ¢ Consultation of the electronic medical record. Application 5 also includes a device interface 28 which must manage communication with the portable medical device 3 through the standard USB port 17 or a Bluetooth Low Energy wireless channel, ensuring reliable transport of the information exchanged between the device 3 and the application program 5. In particular, the device interface 28 must support:

â € ¢ The sending of suitably coded data (coding with proprietary protocol);

â € ¢ The reception on request of data, with integrity check (by means of a 16-bit CRC-CCITT algorithm with polynomial xl6 + xl2 x5 l), and their decoding;

â € ¢ The management of anomalies and the log of pre-established events; Finally, in the user-side application program 5 we can also identify a service interface 29 responsible for managing the communication with the diagnostic center 4 via the Internet 6, ensuring a safe and reliable transport of the information exchanged. In particular, the service interface 29 must support:

â € ¢ Sending data suitably encoded (encoding with proprietary or standard protocol), compressed (lossless compression with standard algorithms, ZIP type) and encrypted (triple DES or others);

â € ¢ On-demand reception of data and their decryption, decompression and decoding;

The management of anomalies and the log of pre-established events.

Similarly, the system 1 of the present invention provides for the use of an application program 7 installed in a personal computer 40 or equivalent host device (palmtop, smartphone, tablet) located in a qualified medical office.

Now, for the purposes of the present invention, the personal computer 40 may or may not coincide with the diagnostic center 4.

It is appropriate that the computer 40 and the diagnostic center 4 are actually structurally and functionally independent; however, nothing prevents the personal computer 40 from being part of the diagnostic center and that therefore the office of the qualified doctor may coincide with the diagnostic center intended in its broadest sense.

For the purposes of the example of implementation described here for indicative and non-limiting purposes, the personal computer 40 will be considered stand alone no more nor less as the personal computer 20 on the user side and the diagnostic center 4 will be considered remote with respect to both processors 20 and 40.

Therefore, the application program 7 of the medical side (or diagnostic center) can in turn be broken down into functional blocks as shown in figure 13.

A first block 43 is indicated as a user interface and allows the doctor to access the program functions in a simple and intuitive way, or to perform all those operations that involve interfacing with the data coming from the 3 ECG portable medical device (for example in a particular outpatient use) and / or with the diagnostic center 4 which are relevant for the analysis and reporting of data.

More specifically, the user interface 43 allows the qualified doctor to manage the following phases:

· User authentication at startup;

â € ¢ Connection to device 3;

â € ¢ Device configuration 3;

â € ¢ Device 3 diagnostics, with any on-board firmware update;

· Visualization of the status of the ECG data (or other data and measurements) present on the device 3;

â € ¢ Transfer of ECG data (or other measurements) from device 3;

â € ¢ Import / export of ECG data (or others) from / ver so files;

· Connection to the diagnostic and reporting center for the management of the remote diagnosis and reporting service;

â € ¢ Connection to the diagnostic and reporting for simple authentication;

â € ¢ Checking the availability of remote ECG data (or other measurements) to be analyzed;

â € ¢ Transfer and take charge of ECG data (or other measurements) and / or the electronic medical record of a given patient;

â € ¢ Display of ECG traces on an electronic millimeter grid with zoom functionality;

· Consultation of the electronic medical record; â € ¢ Simultaneous visualization for comparison of traces of different examinations of the same patient;

â € ¢ Electronic ruler for various measures;

â € ¢ Display of relevant parameters and statistics automatically calculated by the Data Processing block;

â € ¢ Application of particular filtering algorithms and analysis of the results, as well as interpretation and display of the same;

â € ¢ Guided compilation of report 10 using a form with pre-established fields and pre-filled objective data (personal data, measurements, etc.);

â € ¢ Sending the report 10 to the diagnostic and reporting center 4;

â € ¢ Display of the status of the algorithms present and their updating;

â € ¢ Printing of the displayed traces.

A device interface 45 is also provided which allows communication with the portable device 3 to be managed through the standard USB port 17, ensuring reliable transport of the information exchanged between the device and the computer 40. In particular this device interface 45 must support:

â € ¢ The sending of suitably coded data (coding with proprietary protocol)

Receipt of data upon request, with integrity check (using a 16-bit CRC-CCITT algorithm with polynomial xl6 xl2 x5 l), and their decoding

â € ¢ The management of anomalies and the log of pre-established events. A further interface, called service interface 47, is designed to manage communication with the diagnostic center for the purposes of the remote diagnosis and reporting service via the Internet, ensuring safe and reliable transport of the information exchanged. In particular, the service interface must support:

â € ¢ Sending data suitably encoded (encoding with proprietary or standard protocol), compressed (lossless compression with standard algorithms, ZIP type) and encrypted (triple DES or others)

â € ¢ On-demand reception of data and their decryption, decompression and decryption

· The management of anomalies and the log of pre-established events. The figure indicates the presence of a data processing functional block 44 between the interfaces 43 and 45 which comprises a collection of algorithms which will implement functions for processing and analyzing the data received. The individual algorithms will be upgradeable by transfer from a remote service manager, schematized in figure 1 with the numeral 42, which will eventually also provide new algorithms not yet present in the data processing block 44 from time to time. data processing is carried out in the following ways:

· Entirely from the application program 7, using the computing resources of the computer 40 in which it is loaded.

â € ¢ Completely from the remote service diagnosis center 4, in offline mode: in this case the doctor's computer 40 will directly receive the results of a previously performed processing.

â € ¢ In interactive mode, with the doctor's computer 40 who will indicate to the service which portion of data to process and with which parameters, then receiving the results of the processing.

â € ¢ In mixed mode in which portions will be processed locally by the computer 40 and other portions by the diagnosis center 4.

For the sake of completeness of description, it is also necessary to point out the presence of an interface called File Stream designed to manage the reading and writing of ECG data appropriately encoded, encrypted and compressed to and from files resident locally on the doctor's computer 40, or on a similar equivalent host device.

Using this interface, the doctor can, for example, store the data transferred from the 3 ECG portable device locally on a file, and then have the possibility of importing them later in his own application program for viewing and reporting. The same fìles may have been generated remotely and sent to the doctor via the diagnosis center.

This File Stream interface must support:

· The saving of ECG (or other) data appropriately encoded (protocol encoding) and encrypted (triple DES or other) on file to prevent unauthorized access

â € ¢ Reading from ECG data files (or others) and their decryption and decryption if in possession of the necessary access credentials

â € ¢ The management of anomalies and the log of pre-established events. After having analyzed the functional modalities of the processors 20 and 40 with the relative application programs 5 and 7, we will now examine in detail the structure and functioning of the diagnostic and reporting center 4.

In doing so, we will refer to the example of figures 2 and 3.

From a functional point of view, the diagnostic and reporting center 4 allows to coordinate, in accordance with the method of the present invention, an integrated remote diagnosis and reporting service which will be considered below with reference to the blocks highlighted in Figure 2 and in the figures 15 and 16.

This type of service has been organized according to a client-server multi-tier paradigm, i.e. the service includes several levels:

â € ¢ a first level of â € œconnection brokeringâ €, which represents the access point for the computers 20, 40 of the various users / patients and which is responsible for establishing communication with a â € œload balancingâ € approach;

· A second tier that includes a Middle Tier's (MT) collection. The individual MTs implement the Business Logic of the system.

â € ¢ The Data layer which includes a Database 24 and a File System 34.

When a user computer 20 connects to the center 4 it initially communicates with a Broker, who selects the currently less workloaded MT from the various MTs present and then provides the IP address corresponding to the client computer. At this point the client computer establishes the dialogue directly with that given MT.

The single MT exposes different types of services and functionalities to the client and is the only element of the system that can access the Database 24, and through the Database to the File System 34.

The architecture also includes a Web Server 41 for access via standard browser through the portal 9. The Web Server 41 also implements a connection brockering mechanism internally, as the Web Server cannot directly access the Database 24 , but must still rely on a MT (think for example of the registration of a new user via the web).

Everything is protected by a Firewall system well illustrated in figures 15 and 16 and which is suitably replicated to have a backup service that can immediately start operating in the event of an emergency.

This type of architecture in turn can be replicated in different locations to obtain a cluster of equivalent services. For example, one can think of having an independent service for each country or nation.

A functional block indicated with the numeral 48 is in charge of the business logic function, that is to say that this block 48 contains the application logic that makes center 4 operational, that is all the rules and elements related to management and analysis of the information received, to the storage of data, to the sending of information and data in response to requests, etc. Block 48 interacts directly with the Database 24 and with the File System 34, can make use of functions made available by the Services layer and interfaces with external client processors 20, 40 through the Communication block 8. From a point of view functional, the business logie block 48 must be able to manage the safe and controlled transport of the exchanged data. In particular, at least the following operations must be supported:

â € ¢ The safe and controlled transport of the exchanged data, i.e. the reception of data and their decryption, decompression and decoding and the sending of appropriately encoded, compressed and encrypted data

Authentication of credentials at least for the following categories of users:

- New patient

- New doctor

- Patient already registered in the system

- Doctor already registered in the system

â € ¢ Registration and insertion in the Database of new medical users and patients

â € ¢ Notification to the Patient Client of the presence of a new firmware for the device and updating of the same

· Notification to the Medical Client of the presence of a new algorithms and their updating

â € ¢ Receipt of new ECG data {or others) to be analyzed, their storage in the File System and insertion in the Database

â € ¢ Notify physicians of new ECGs (or others) to be analyzed

On request, sending to the Medical Client of ECG data to be analyzed, with possible pre-processing of the same

â € ¢ Receipt of reports from the Medical Client, their storage in the File System and insertion in the Database

â € ¢ Notify patients of the availability of the report 10

â € ¢ On request sending to the Patient Client of the report 10

â € ¢ System status monitoring, event logs and notification to the system administrator of particular events

The Database 24 and the File System 34 are the two components of the management system of the diagnostic center 4 responsible for storing information and data. In particular, the Database 24 is structured to contain all the electronic folders and the logical models for the insertion, search, cancellation and updating of the following categories of information:

Patient data, including at least:

Personal data

Login credentials

Health data, medical records

List of ECG examinations {or others) carried out, their processing status and reference to the data stored in the File System

List of reports, their notification status and reference to the data stored in the File System

â € ¢ Physician data, including at least:

Personal data

Login credentials

- Serial number and registry of the Order of Doctors - List of ECG examinations (or others) analyzed or currently under analysis

- List of reports produced

System administrator data, including at least: - Personal data

- Login credentials

- Permits and authorizations to carry out certain operations

System configuration, including at least:

- Versioning data for all software and firmware tools of the system (Patient Client, Doctor Client, algorithms, device firmware, Business Logic, etc.).

- General configuration parameters

* Event log

The File System 34, on the other hand, is the archive of all the files of the ECG traces and the corresponding reports. The organization of this archive will be managed by specific Database 24 structures containing explicit references to each file.

The operational management of these resources is delegated to an interface management block 49 with the system administrator 42.

This interface 49 is the tool with which all the installation, configuration and maintenance operations of the system installed at the diagnostic and reporting center 4 and its elements are carried out. Through this interface 49 the administrator 42 connects locally to a MT and through it can access the Database 24 and the File System 34.

Let us now see the methodology object of the present invention.

As well known to the operators of this sector, the basal ECG must be performed with the patient in conditions of rest and consists in recording the electrical activity of the heart for a duration of a few minutes by applying the electrodes 25 to the chest.

By means of the system 1 of the invention, and in particular thanks to the portable medical device 3, the basal ECG can therefore be performed at the patient's home or in any place where there is the possibility of staying for a few minutes in conditions rest.

For the sake of completeness of description, the operations to be carried out to perform a baseline ECG examination using system 1 are as follows:

Application of the electrodes to the patient's chest;

Connection by means of the cable 15 of the electrodes to the portable medical device 3;

Start recording of cardiac traces;

Removal of cable and electrodes after registration is complete, after a few minutes.

For all these operations, the user can proceed autonomously in all the steps or possibly get help from a family member or an acquaintance, but not necessarily a specialist or a health worker.

The data thus acquired, and stored in the memory bank 35 of the portable medical device 3, are ready to be transferred from the ECG recorder by means of the application 5 on the user / patient side which makes them available to a qualified doctor for diagnosis and the reporting.

The following representative scenarios can be considered as use cases:

> Home / personal use

The acquisition is carried out at home by the user himself. The data is transferred from the portable medical device 3 to the computer 20 of the user by means of the application 5. By relying on the remote diagnosis service, the user then transmits the data to the computer 40 of the qualified doctor. The doctor performs the data analysis and reporting assisted by the application program 7, finally sending the results both to the diagnostic and reporting center 4 and to the patient. The user can then go to a specialist with a copy of the report 10 for further checks if there is an indication to this effect in the report itself.

> Standard outpatient use

In this scenario, the patient goes to the clinic and the data acquisition procedure is carried out by medical personnel with the same tools as in the previous case. The only difference may consist in the fact that the data acquired by means of the portable medical device 3 can be transferred directly to the doctor's computer 40, by means of the same application program 7 which provides for the possibility of acquiring data in the same way as envisaged for the user-side application program 5.

With the same software the doctor carries out the diagnosis and reporting. The report can be delivered directly at the end of the visit or on a deferred basis according to the internal regulations of the individual outpatient structures.

> Home visit by a doctor

In this scenario it is the doctor who goes to the patient for a home visit during the acquisition procedure, the 3 ECG medical device shows the traces on display 19, giving the doctor the possibility of making an initial immediate diagnosis. At the end of the visit, the doctor transfers the data acquired by the device 3 to his computer 40 by means of the application program 7 included in the system and with the application 7 carries out the diagnosis and reporting. The report is then sent to the patient.

> Health emergency situation

In the event of a health emergency, the system 1 with the portable device 3 can be used by a rescuer to monitor the heart conditions of the patient who needs help. During acquisition, the 3 ECG portable device shows the traces in real time on the display 19, giving the rescuer the possibility of making an initial diagnosis. At the end of the acquisition, the data can be transferred from the device 3 to a computer 40 of the qualified doctor by means of the application 7 included in the system to carry out a more accurate diagnosis by qualified medical personnel.

The dynamic ECG according to the Holter method consists in the continuous recording of cardiac activity for a prolonged period (24/48 hours) in all situations of daily life: activity, rest, excitement, relaxation, wakefulness, sleep, etc. Also in this case it is necessary to apply the electrodes 25 to the patient's chest and connect them to the medical device 3 ECG using the appropriate cable 15. The recording of the traces is then started and the device 3 ECG is placed in a case with shoulder strap or can be fastened to the belt for convenient carrying during the acquisition period.

Similarly to what has already been reported, the scenarios of home / personal use and standard outpatient use can be considered. In this last case, the patient goes to the clinic for the application of the electrodes, then leaves the health facility and normally carries out his daily activities; after 24/48 hours, the user goes back to the health facility where the cables and electrodes are removed and the data transferred from the portable medical device 3 directly to the doctor's computer 40.

An important feature of the service offered with the system and method of the present invention is the whole for ability, understood as the ability to automatically exchange information with other medical devices and to archive clinical data in a structured way in general. The user will also have the possibility to insert reports belonging to his or her past clinical history using a special software tool provided by the service. In this way, a telematic medical record will be created which can be consulted at any time by the user himself, as well as by doctors authorized by him. For consultation only, it will also be possible to use the web portal 9 accessible via a traditional internet browser. The web portal also allows the user to register their device after purchase, verifying its authenticity.

Only after registration and positive verification will it be possible to enable all the functions of the device through the software. At any time it will then be possible to block the device either at the request of the user or at the initiative of the manufacturer (for example in the event of theft / loss or production batches with serious defects).

In turn, the portable medical device 3 has intrinsic characteristics of interoperability as it can be used as a host platform to which plug-in measurement systems (glucosometers, pulse oximeters, blood pressure gauges, etc.) can be connected (via USB port, HDMI or via Bluetooth). ), thus using the plugin to perform the measurement and the host platform for control, interaction with the user and subsequent interfacing with a computer and with the remote diagnosis and reporting service of the center 4.

The system and the method according to the invention, as well as the services based on them, do not intend in any way to replace the outpatient diagnostic activity, but rather aim to integrate it with a frequent screening on the population that can act as a bell alarm, but never as a replacement medical examination. The implementation of digital medical records accessible via the Internet would also help doctors to have a more complete clinical picture of the patient, allowing further savings in time and money.

Furthermore, through the various accessories dedicated to quick coupling, measurements of many vital or clinical parameters can be made available, such as the level of glucose in the blood for diabetic patients or the level of oxygen saturation in the blood.

As a secondary objective considering the outpatient use there is the possibility of providing a high quality and low cost diagnostic device to doctors, public and / or private health structures.

Claims (15)

CLAIMS 1. System for remotely acquiring ECG data and / or other measurements of vital or clinical parameters of patients and transmitting said data and measurements and a diagnostic and reporting center, characterized by the fact of including: a portable medical device (3) powered by batteries and incorporating at least one connection port (22) for a quick-fit ECG cable (15) as well as an A / D converter and a memory (35) for temporarily storing ECG data and / o measurements of the patient's vital or clinical parameters (2); a remote computer (40) installed at said diagnostic center and containing electronic files referring to each user / patient (2); an application program (5) installed in a personal computer (20) supplied to the user / patient (2) to automatically transfer said ECG data and / or said measurements from said memory (35) to the remote computer (40 ) of a qualified doctor or of said diagnostic center (4); an application program (7) installed in the computer (40) of the qualified doctor or of said diagnostic center to collect said ECG data and / or said measurements, as well as diagnoses made on the basis of said ECG data and measurements to be associated with the records electronic related to the relative users / patients (2). 2. System according to claim 1, characterized in that said portable medical device (3) comprises an ECG data acquisition device (11) connected by means of said port (22) to the quick-coupling ECG cable (15) and also having a further gate (23) for at least one probe for measuring at least one of said vital or clinical parameters. 3. System according to claim 1, characterized in that said portable medical device (3) comprises a motherboard (21) and a secondary card (31) or daughter card interconnected by means of respective board-to-board connectors (61) and an FPC cable. 4. System according to claim 3, characterized by the fact that said secondary card (31) is structured and specialized for the acquisition of electrocardiographic signals by means of an Analog Front-End (AFE) component (63) which detects differential measurements on several amplifiable channels with independent and programmable gain and programmable sampling frequency. 5. System according to claim 4, characterized in that said electrocardiographic signals are filtered by an ESD protection circuit block (65) also designed to provide an output protection to protect the patient from possible sink and source currents. 6. System according to claim 1, characterized in that at least one memory is a bank (35) of non-volatile memory units comprising at least one Flash memory and at least one micro IC-card that can be inserted and removed in a relative seat of the device ( 3). 7. System according to claim 1, characterized in that said application program (5) on the user side automatically manages the acquisition of the data stored in said memory (35) of the portable medical device (3) 8. System according to claim 2, characterized by the fact that said further port (23) is of the USB type and that said ECG cable (15) has a right angle connector (17) (17) which, when inserted, obstructs the access to said further USB port (23). 9. System according to claim 1, characterized by the fact that said portable medical device (3) is able to act as a host platform by supplying power to the various external sensors (67, 68) possibly connected in plug-in mode to the device on the USB port (23) or the HDMI port (22). 10. Method for remotely acquiring ECG data and / or other measurements of vital or clinical parameters of patients and transmitting said data and measurements and a diagnostic and reporting center, characterized by the following phases: - acquire said ECG data and / or measurements of the patient's vital or clinical parameters (2) by means of a portable medical device (3) powered by batteries, having a connection port (22) for a quick-fit ECG cable (15) and incorporating at least an A / D converter and a memory (35) for temporarily storing said ECG data and said measurements; - subsequently transferring said ECG data and / or said measurements from said memory (35) to a remote computer (40) of a qualified doctor or said diagnostic center by means of an application program (5) installed in a personal computer (20) supplied to the user / patient (2); - remotely carry out a diagnosis phase on said ECG data and / or said measurements and associate the results of said diagnosis phase to an electronic file referring to said user / patient (2) by means of an application program (7) installed at the ™ computer (40) of the qualified physician or of said diagnostic center; - make this electronic file available to the same user / patient (2) to consult the results of the diagnosis. 11. Method according to claim 10, characterized in that the step of transferring said ECG data and / or said measurements between the portable medical device (3) and the personal computer (20) supplied to the user / patient (2) takes place automatically with wireless transmission mode, or by means of a quick-fit connection, under the supervision of said application program (5) on the user / patient side (2). 12. Method according to claim 10, characterized in that the step of making said electronic file available involves querying a database of said diagnostic and reporting center by means of a web portal (9). 13. Method according to claim 10, characterized in that the step of associating the results of the diagnosis to the electronic file referred to said user / patient (2) is performed automatically by said application program (7) following the identification of the € ™ user / patient (2). 14. Method according to claim 10, characterized by the fact that said portable medical device (3) is able to act as a host platform by supplying power to the various external sensors (67, 68) possibly connected in plug-in mode to the device on the door USB (23) or the HDMI port (22). Method according to claim 10, wherein said qualified physician computer (40) and said diagnostic center computer are structurally independent.