System and method for monitoring an abdominal aortic aneurysm

Abstract

A system and a method for continuously monitoring an abdominal aortic aneurysm are described. The system (100) comprises an internal unit (10), which comprises at least one sensor (S1, S2, S3, S4) for detecting blood pressure and flow data inside the aneurysmal sac and an electronic control unit (11) in electrical communication with the at least one sensor (S1, S2, S3, S4); an external unit (20) in electrical communication with the internal unit (10); and a remote server (30) in electrical communication with the external unit (20). The external unit (20) is configured to read the blood pressure and flow data detected by the at least one sensor (S1, S2, S3, S4) of the internal unit (10) and transmit them to the remote server (30) for their analysis, organization and protection.

Description

[0001] “System and method for monitoring an abdominal aortic aneurysm”

[0002] Field of the invention

[0003] The present invention generally concerns the technical field of endovascular systems. In particular, the present invention concerns a system and a method for continuously monitoring an abdominal aortic aneurysm.

[0004] Known art

[0005] Abdominal aortic aneurysm (AAA) consists in a localized and permanent dilation of the abdominal aorta, characterized by an increase in diameter of at least 50%. This dilation is generally due to a degeneration of the artery wall: the vessel, deprived of its normal elasticity, progressively increases in caliber due to blood pressure pushing.

[0006] Abdominal aortic aneurysms, whose epidemiological incidence is of 38 cases per 100,000 individuals, are treated with endoprosthesis (Endovascular Aneurysm Repair - EVAR), i.e. by means of a prosthesis, which is positioned at the abdominal aortic aneurysm by means of a catheter inserted into the patient’s body through the femoral artery. In particular, the prosthesis has the function of protecting the aorta from rupture (fatal event), but the wall of the aneurysm is very often still perfused by circulating blood, which oozes from the prosthesis and which allows for the at least partial rehabilitation of the vascular malformation.

[0007] EVAR is therefore a therapeutic advancement representing a valid alternative to conventional endovascular or open abdominal surgery (laparotomy), which is currently the most commonly used procedure for repairing abdominal aortic aneurysms.

[0008] Currently, monitoring of the state of an abdominal aortic aneurysm, specifically of the proper positioning and proper functionality of the prosthesis used to treat the aneurysm, occurs by means of abdominal computed tomography (CT) with contrast medium, to initially be performed each month and then every four months.

[0009] Although effective, the abdominal CT exam has the drawback of only having clinical and non-instrumental monitoring of the abdominal aortic aneurysm between one CT and the next. As a result, it is not possible to prevent complication due to a new dilation of the arterial vessel, by to blood rehabilitation with a consequent risk of rupture.

[0010] The Applicant has therefore addressed the problem of providing a more effective system and method for monitoring the proper positioning and the proper functionality of a prosthesis for the treatment of an abdominal aortic aneurysm.

[0011] Object of the present invention is therefore to provide a system and a method for monitoring an abdominal aortic aneurysm, which are configured so as to continuously detect blood pressure and flow over time inside an aneurysmal sac, in which there is a prosthesis for the treatment of the abdominal aortic aneurysm, and to transmit the blood pressure and flow data detected to the outside, for their processing and / or storing.

[0012] Another object of the present invention is to provide a system and a method for monitoring an abdominal aortic aneurysm, such that to allow authorized personnel, for example the patient or a treating physician, to access the blood pressure and flow data detected.

[0013] Another object of the present invention is to provide a system and a method for monitoring an abdominal aortic aneurysm, such that to allow to continuously update the blood pressure and flow data detected, so as to accurately follow a patient's condition over time.

[0014] Still, another object of the present invention is to provide a system for monitoring an abdominal aortic aneurysm, configured so as to reduce its energy consumption to a minimum, thereby increasing its operating life.

[0015] Last, but not least, object of the present invention is to provide a system for monitoring an abdominal aortic aneurysm, configured so as to be simple to implement and which can be manufactured at competitive costs.

[0016] Summary of the invention

[0017] These and further objects are achieved by the present invention thanks to a system and a method for monitoring abdominal aortic aneurysm according to independent claims 1 and 10. Further preferential characteristics and aspects of the invention are set out in the dependent claims.

[0018] In a first aspect, the invention therefore concerns a system for monitoring an abdominal aortic aneurysm, characterized by comprising: an internal unit, which comprises at least one sensor for detecting blood pressure and flow data inside the aneurysmal sac and an electronic control unit in electrical communication with the at least one sensor; an external unit in electrical communication with the internal unit; and a remote server in electrical communication with the external unit. The external unit is configured to read the blood pressure and flow data detected by the at least one sensor of the internal unit and transmit them to the remote server for their analysis, organization and protection.

[0019] Thanks to this combination of characteristics, in particular, thanks to the presence of an internal unit, an external unit and a remote server in communication with each other, the system for monitoring an abdominal aortic aneurysm advantageously allows to continuously check the state of the prosthesis and that of the surrounding tissues, reduce the number of abdominal CT exams, consequently resulting in less patient exposure to ionizing radiation and in a drastic reduction of the waiting lists for such exams, and reduce the administration of contrast medium, which overburdens renal function.

[0020] In an embodiment, the internal unit further comprises a radio frequency identification Tag and an antenna, wherein the radio frequency identification Tag is in electrical communication with the electronic control unit and communicates, through the antenna, with the external unit.

[0021] In an embodiment, the internal unit further comprises a hardware module, which acts as an interface between each sensor and the electronic control unit and is configured to convert the signals coming from each sensor into a format understandable by the electronic control unit.

[0022] In an embodiment, the radio frequency identification Tag comprises a radio frequency communication module, an “Energy Harvesting” module, configured to exploit a magnetic field generated for communication with the external unit, and a memory, preferably an EEPROM memory. In an embodiment, the at least one sensor of the internal unit is a digital sensor and the hardware module comprises an analog multiplexer controlled by the electronic control unit. Alternatively, the at least one sensor of the internal unit is a digital sensor and the hardware module comprises, in addition to the analog multiplexer, an IC module, both controlled by the electronic control unit.

[0023] In an embodiment, the internal unit comprises a flexible printed circuit board to which the at least one sensor is electrically connected and on which the electronic control unit, the hardware module, the radio frequency identification Tag and the antenna are positioned.

[0024] The printed circuit board is preferably rectangular in shape with a length ranging from about 80 mm to about 38 mm and a width ranging from about 40 mm to about 14 mm. The electronic control unit, the hardware module and the radio frequency identification Tag are arranged at the centre of the printed circuit board, following a fixed rectangular configuration, which extends longitudinally to the printed circuit board.

[0025] In an embodiment, the antenna of the internal unit has the shape of a series of tracks which extend, parallel to one another and suitably spaced at a peripheral edge of the printed circuit board.

[0026] In an embodiment, the internal unit comprises a biocompatible coating preferably constituted by a layer of parylene C.

[0027] In an embodiment, the external unit comprises an antenna, in communication with the antenna of the internal unit and configured to generate a magnetic field in order to provide the internal unit with a start command and the energy necessary for power supply, without the use of batteries.

[0028] In a second aspect, the invention concerns a method for monitoring an abdominal aortic aneurysm, carried out by using the system 100 as defined above. The method comprises the following steps of:

[0029] - detecting, by means of at least one sensor of an internal unit of the system, blood pressure and flow data inside the aneurysmal sac;

[0030] - reading, by means of an external unit of the system, the blood pressure and flow data detected by the at least one sensor of the internal unit; and

[0031] - transmitting the blood pressure and flow data read to a remote server through the external unit.

[0032] In an embodiment, the step of detecting blood pressure and flow data comprises, for each sensor, the following sub-steps of:

[0033] - selecting a sensor;

[0034] - checking if the selected sensor requires blood pressure and / or flow data to be detected, following a detection start command previously transmitted by the external unit; and

[0035] - in the affirmative, detecting the blood pressure and / or flow data of the sensor n times, calculating the average and saving a code indicating detection of success or error message.

[0036] In an embodiment, the method comprises a preliminary step of verifying the presence of a detection start command, which comprises the following sub-steps carried out in parallel, respectively, by the internal unit and external unit of the system

[0037] - cyclically executing, by means of the internal unit, a series of readings from its own memory, to check whether there is a detection start command sent by the external unit;

[0038] - transmitting, by means of the external unit, a magnetic field to establish a connection to the internal unit;

[0039] - checking the presence of connection; and

[0040] - in the affirmative, writing, by means of the external unit, specific instructions into the memory of the internal unit; and

[0041] - entering, by the external unit, a constant waiting state, keeping the magnetic field active.

[0042] Brief description of the drawings

[0043] The invention will be described hereunder with reference to the accompanying drawings provided by way of example only and therefore not limiting, in which:

[0044] - Figure 1 shows a schematic view of a system for monitoring an abdominal aortic aneurysm according to the present invention; - Figure 2 shows a block diagram of different components of an internal unit of the monitoring system of Figure 1;

[0045] - Figure 3 schematically shows an embodiment of a hardware module of the internal unit of Figure 2;

[0046] - Figure 4 schematically shows an alternative embodiment of the hardware module of the internal unit of Figure 2;

[0047] - Figure 5 schematically shows the method for communicating data and transferring energy between an external unit and the internal unit of the monitoring system according to the present invention;

[0048] - Figure 6 shows a schematic plan view of a possible embodiment of the internal unit of the monitoring system of Figure 1;

[0049] - Figure 7 shows a schematic plan view of a printed circuit board of the internal unit of Figure 6 as it switches from a wound configuration (shown on the left) to a flat or unfolded configuration (shown on the right);

[0050] - Figure 8 is a flow diagram showing different steps of a method for monitoring an abdominal aortic aneurysm according to the present invention; and

[0051] - Figure 9 is a flow diagram showing the sub-steps of a preliminary step of checking the presence of a detection start command of the method according to the present invention.

[0052] Detailed description of the invention

[0053] With reference to Figure 1, a system for monitoring an abdominal aortic aneurysm according to the present invention is depicted therein.

[0054] The system, generally denoted by the number of reference 100, comprises an internal unit or Tag 10, an external unit or Reader 20 and a remote server 30.

[0055] The internal unit 10 is a miniaturized implantable detection unit which, in use, is delivered into the aneurysmal sac via a catheter of appropriate size, which is positioned in the sac until the completion of stent grafting procedure and subsequently removed.

[0056] The internal unit 10 is configured to detect, with high sensitivity, blood pressure and flow data inside the aneurysmal sac and transmit the pressure and flow data detected to the external unit 20.

[0057] For this purpose and as shown in detail in Figure 2, the internal unit 10 comprises a plurality of sensors, preferably four sensors SI, S2, S3, S4 to detect blood pressure and flow inside the aneurysmal sac. In particular, the sensors SI, S2, S3, S4 provide pressure readings in absolute values, with an optimal measurement range of 750 mmHg to 1050 mmHg.

[0058] The sensors SI, S2, S3, S4 can be of active or passive type. The active sensors have the advantage of being able to autonomously perform point or also possibly continuous measurements, or anyhow with a certain frequency, without having to involve the patient. However, they require internal energy storage which consequently increases their size, therefore making their insertion into the aneurysmal sac with the normal endoscopic systems more complex, if not difficult to achieve. Passive sensors are certainly smaller in size, however an external excitation system (power supply and data request) would be necessary to be able to take pressure readings in the aneurysmal sac. Such solution requires the participation of the patient in every monitoring, therefore always psychologically and mentally binding him / her to his / her health state, with possible negative consequences in relation to adherence to treatment if such monitoring should only be performed sporadically.

[0059] Passive sensors, which are read by the external unit 20 once a day (possibly once every 12 hours), are preferably used. An active sensor is not necessarily needed with this frequency.

[0060] The internal unit 10 further comprises an electronic control unit 11, for example a microcontroller, in electrical communication with the sensors SI, S2, S3, S4. Communication between the electronic control unit 11 and the sensors SI, S2, S3, S4 preferably occurs through the digital I2C protocol, therefore ensuring a stable and effective connection. In particular, the electronic control unit 11 is configured to execute software instructions to monitor the sensors SI, S2, S3, S4, process the data, make decisions and manage other hardware devices.

[0061] The internal unit 10 preferably comprises a hardware module 12 which acts as an interface between the sensors SI, S2, S3, S4 and the electronic control unit 11 and is configured to convert the signals coming from the sensors SI, S2, S3, S4 into a format understandable by the electronic control unit 11.

[0062] With reference to Figure 3, an embodiment of a hardware module 12, relating to a monitoring system 100 in which digital sensors SI, S2, S3, S4, i.e. sensors whose output is already in digital format, are implemented, is shown therein.

[0063] In such embodiment, the hardware module 12 comprises an analog multiplexer 121 controlled by the electronic control unit 11.

[0064] In particular, the analog multiplexer 121 operates as a switch by selecting the sensor SI, S2, S3, S4 to be triggered on the I2C bus at a given moment. The electronic control unit 11 controls the multiplexer 121 and sends, when needing to interact with a given sensor SI, S2, S3, S4, a signal (SEL) to the multiplexer 121 to select the proper communication channel.

[0065] The multiplexer 121 mainly intervenes on the SDA (Serial Data) channel, routing the SDA signal towards the sensor selected on the I2C bus, while the SCL (Serial Clock) channel is shared by all the sensors SI, S2, S3, S4 connected to the I2C bus. This allows to communicate with a single sensor at a time, even though they all share the same communication line. Moreover, the fact of using digital sensors does not make the presence of an IC module for digital conversion necessary, since this function is already integrated into the sensors themselves.

[0066] With reference to Figure 4, an alternate embodiment of a hardware module 12’, relating to a monitoring system 100 comprising analog sensors SI, S2, S3, S4 whose signal therefore needs to be converted into digital format, is shown therein.

[0067] In such embodiment, the hardware module 12’ comprises, in addition to the multiplexer 121, an IC module 122 also controlled by the electronic control unit 11. The IC module 122 is configured to convert the signals coming from the sensors SI, S2, S3, S4, specifically the capacitances of the sensors SI, S2, S3, S4, into digital signals for the electronic control unit 11. The multiplexer 121 is configured to select one or more sensors SI, S2, S3, S4 from which to acquire data according to the method described above with reference to the embodiment of Figure 3.

[0068] Again, with reference to Figure 2, the internal unit 10 further comprises a radio frequency identification Tag, or RFID Tag, 13, in electrical communication with the electronic control unit 11, and an antenna 14 in electrical communication with the RFID Tag 13. The RFID Tag 13 communicates, via the antenna 14, with the external unit 20 of the monitoring system 100.

[0069] The RFID Tag 13 is configured to store data, such as serial numbers, identifiers, authentication information and other specific data, and communicates with the external unit 20 without requiring physical contact, by exploiting the RFID (Radio Frequency Identification) technology to exchange data with the external unit 20, when triggered by its RF signal.

[0070] The antenna 14 has the task of receiving energy and radio frequency signals, or RF signals, from the external unit 20, this way triggering the RFID Tag 13. In other words, the antenna 14 acts as a bridge between the RFID Tag 13 and the external unit 20, therefore allowing the communication of the RFID Tag 13 without requiring its own battery.

[0071] In particular, the antenna 14 has impedance aligned with the internal tuning capacitance value of the device (Ctuning) to form a circuit which has a tuning or resonant frequency (ftiming) of about 13.56 MHz.

[0072] The essential equation for the tuning frequency is the following: where Lantenna is the inductance of the antenna 14.

[0073] The RFID Tag 13 preferably is an ST25DV NFC Tag / RFID Dynamic Tag IC, characterized by the ability to keep communications at greater distances than conventional NFC (Near Field Communication) Tags. The RFID Tag 13 preferably uses the ISO 15693 communication protocol and operates at a frequency equal to the resonant frequency of the antenna 14, i.e. at a frequency of 13.56 MHz.

[0074] The RFID Tag 13 comprises a radio frequency communication module 131, or RF communication module, an "Energy Harvesting" module 132 configured to exploit a magnetic field generated for communication with the external unit 20, and a memory 133. The memory 133 preferably is an EEPROM (Electrically Erasable Programmable Read-Only Memory) memory which can be both read and written and which acts as a communication means between the internal unit 10 and the external unit 20. Such memory is accessible via RF communication with the external unit 20 but it is also possible to access it physically via the electronic control unit 11 by using digital communication protocols, such as I2C.

[0075] The EEPROM memory of the internal unit is programmable, which advantageously allows the monitoring system 100 to operate optimally. During communication, different specific operations are performed, such as for example, from the Reader to the Tag, instructions for starting to collect data, configuring the type of data to be acquired and selecting which sensors to read, and, from the Tag to the Reader, transmitting information about the data collected, sensor status and various reports on the state of the system or error codes.

[0076] In the embodiment depicted in Figure 6, the internal unit 10 comprises a preferably flat printed circuit board, or PCB 15, to which the sensors SI, S2, S3, S4 for measuring blood pressure and flow inside the aneurysmal sac are connected.

[0077] The printed circuit board 15 is flexible to be folded reversibly, without compromising the integrity of the electrical and electronic components it supports and electrically connected thereto. In particular, when the implantable detection device 100 is implanted into the aneurysmal sac by using a catheter, the flexible printed circuit board 10 can advantageously be wound around a guide wire for the catheter and subsequently unfolded, so that to resume its initial, preferably flat, configuration once the site of interest has been reached. The transition of the printed circuit board 15 from the wound position to the unfolded position is shown in Figure 7, wherein the printed circuit board 15 is visible in the wound position on the left, while the printed circuit board 15 is shown in the unfolded position on the right.

[0078] Moreover, the printed circuit board 15 is of the single layer or multilayer type and preferably is rectangular in shape with a length ranging from about 80 mm to about 38 mm and a width ranging from about 40 mm to about 14 mm.

[0079] In the embodiment shown in Figure 6, the sensors SI, S2, S3, S4 are of the “wire-like” type, i.e. floating in the volume to be monitored and constituted by the aneurysmal sac. For such purpose, the sensors SI, S2, S3, S4 are positioned on a thin strip 16 of conductive material, which extends longitudinally from the printed circuit board 10.

[0080] In particular, the electronic control unit 11, the hardware module 12 and the RFID Tag 13 are arranged at the centre of the printed circuit board 15 following a fixed rectangular configuration, which extends longitudinally to the printed circuit board 15. Such rectangular configuration advantageously allows to prevent mechanical stress, which could occur when winding the printed circuit board 15 during the step of positioning the internal unit 10 at the site of interest, and to reduce to the minimum the risk of the electronic control unit 11, the hardware module 12 and the RFID Tag 13 becoming detached from their soldering points.

[0081] The size of the rectangular configuration according to which the electronic control unit 11, the hardware module 12 and the RFID Tag 13 are arranged preferably is such that the printed circuit board 15 fits optimally inside the positioning catheter of the internal unit 10. In particular, the rectangular configuration has a length 1 equal to about 23 mm and a width w equal to about 4 mm.

[0082] The antenna 14 has the shape of a series of tracks 14a, 14b, 14c which extend, parallel to one another and suitably spaced, at a peripheral edge of the printed circuit board 10.

[0083] The internal unit 10 is preferably provided with a biocompatible coating or encapsulation, which protects the patient from adverse reactions or damage to adjacent tissues, while preserving the operations of the internal unit itself. Moreover, the coating of the internal unit ensures good interaction of the sensitive part of the pressure sensors with the external environment represented by the aneurysmal sac isolated by the prosthesis. This to prevent a degradation of the quality of the intra- aneurysmal pressure measurement.

[0084] In a particularly preferred embodiment, the biocompatible coating is constituted by a thin layer (about 1-2 pm) of parylene C.

[0085] With reference to Figures 1 and 5, the external unit or Reader 20 is a control unit which is positioned outside the body of the patient and configured to constantly read the pressure data detected by the internal unit 10.

[0086] The external unit 20 is further configured to provide the internal unit 10 with a start command and the energy necessary for power supply, without the aid of batteries. For such purpose and as shown in detail in Figure 5, the external unit 20 comprises a preferably loop-like antenna 24 and the internal unit 10 receives all the energy necessary for operating from the magnetic field created by the external unit 20 through that antenna 24. In other words, the external unit 20 - internal unit 10 assembly is similar to a voltage transformer, where the external unit 20 acts as a primary winding and the internal unit 10 as a secondary winding. It is important to note that the energy is not stored, but used completely.

[0087] The external unit 20 therefore performs a dual function inside the monitoring system 100, i.e. it starts the internal unit 10 by providing energy through the magnetic field generated and accesses the memory 133 of the internal unit both in reading and writing modes. The external unit 20 subsequently enters a constant waiting state, keeping the magnetic field active. This ensures that the internal unit 10 stays powered and able to perform its functions.

[0088] The external unit 20 is further provided with an attachment system (not shown) for being attached on the body of a user, for example a belt or transcutaneous implant.

[0089] Again, with reference to Figure 1, the remote server 30 is configured to receive the blood pressure and flow data detected by the internal unit 10 and read by the external unit 20, for their analysis, organization and protection. The remote server 30 further allows the patient, treating physician and anyone with authorized access to access the data. In particular, a user can download an intuitive e-health application, which is designed to analyze the data collected by the devices and send automatic notifications to health care facilities, physicians and patients, to interface devices, such as smartphones, tablets (and others). The remote server 30 preferably is a back-end system hosted on cloud infrastructure.

[0090] In an embodiment variant and still with reference to Figure 1, the monitoring system 100 has a subcutaneous intermediate station 40 (of the pacemaker mode type) for energy storage and data collection, which is located in an ideal anatomical position which minimizes its distance from the internal unit 10.

[0091] With reference to Figures 8 and 9, a method for continuously monitoring an abdominal aortic aneurysm, performed by using the monitoring system 100 described above and illustrated in Figures 1 to 7, will now be described.

[0092] The method starts with a preliminary step SI of checking the presence of a detection start command, which is shown in detail in Figure 9. Such step comprises the following steps carried out in parallel, respectively by the internal unit 10 and the external unit 20.

[0093] In particular, the internal unit 10 cyclically executes - step Si l - a series of readings from the memory 133, once sufficient energy for being triggered has been received from the external unit 20, to check whether there is a detection start command (sent by the external unit 20). In turn, the external unit 20 starts to transmit - step S12 - a magnetic field and attempts to establish a connection to the internal unit 10. Once the connection has been established - step S13, YES - as indicated by the detection by the external unit 20 of the presence of the internal unit 10 inside the magnetic field generated, the external unit 20 writes - step S14 - specific instructions into the memory of the internal unit 10. These instructions can include various configurations for collecting data, requesting feedback or issuing commands for starting to acquire data. After having sent these instructions, the external unit 20 enters - step S15 - a constant waiting state, keeping the magnetic field active. This ensures that the internal unit 10 stays powered and able to perform its functions.

[0094] With reference to Figure 8, when the acquisition start command is identified (step SI, YES), the internal unit 10 continues by reading the configurations saved in memory and the method proceeds with a step S2 of detecting blood pressure and flow data, which comprises, for each sensor SI, S2, S3, S4, the sub-steps of:

[0095] - selecting, S21, a sensor (in this case, one of the four sensors in the strip of sensors);

[0096] - checking, S22, whether the selected sensor requires the acquisition of the blood pressure and / or flow value (configuration instructions from the external unit 20);

[0097] - in the affirmative (step S22, YES), acquiring, S23, the blood pressure and / or flow value of the sensor n times (five times in this case), calculating the average, therefore providing a more precise reading, and saving a code specifying success acquisitions and error messages.

[0098] If errors occur during sensor acquisition, the acquisition cycle is interrupted and the error code identifying the problem of the sensor is memorized.

[0099] Once the step S2 of acquiring and collecting data for each sensor has been completed, the method proceeds to a step S3 of writing all the values and feedback messages into the memory 133 of the RFID Tag 12 of the internal unit 10.

[0100] The method proceeds with a reading step S4, during which the external unit 20 reads the results by accessing the memory 133 of the internal unit via RF communication, followed by a step S5 in which, once the instructions were successfully executed, the external unit 20 disconnects from the internal unit 10 and completes its function, also deactivating the magnetic field it had generated.

[0101] The method further comprises a step S6 of transmitting, to the remote server 30, the blood pressure and flow data read by the external unit 20, for their organization and protection. Moreover, through the e-health application, a user, for example with his / her smartphone, can analyze the data collected by the sensors and health care facilities, physicians and patients can receive automatic notifications.

[0102] Thanks to the present invention, it is possible to obtain a system and a method for monitoring an abdominal aortic aneurysm such that to allow to continuously check the state of the prosthesis and that of the surrounding tissues, reduce the number of abdominal CT exams, consequently resulting in less patient exposure to ionizing radiation and in a drastic reduction of the waiting lists for such exams, and reduce the administration of contrast medium, which overburdens renal function.

[0103] Various modifications may be made to the embodiments described in detail, all anyhow remaining within the protection scope of the invention, as defined by the following claims.

Claims

CLAIMS1. System (100) for monitoring an abdominal aortic aneurysm characterized in that it comprises: an internal unit (10), which includes at least one sensor (SI, S2, S3, S4) for detecting blood pressure and flow data inside the aneurysmal sac and an electronic control unit (11) in electrical communication with the at least one sensor (SI, S2, S3, S4); an external unit (20) in electrical communication with the internal unit (10); and a remote server (30) in electrical communication with the external unit (20); wherein the external unit (20) is configured to read the blood pressure and flow data detected by the at least one sensor (SI, S2, S3, S4) of the internal unit (10) and transmit them to the remote server (30) for their analysis, organization and protection.

2. System (100) according to claim 1, wherein the internal unit (10) further comprises a radio frequency identification Tag (13) and an antenna (14), wherein the radio frequency identification Tag (13) is in electrical communication with the electronic control unit (11) and communicates, through the antenna (14), with the external unit (20).

3. System (100) according to claim 1 or 2, wherein the internal unit (10) further comprises a hardware module (12; 12'), which acts as an interface between each sensor (SI, S2, S3, S4) and the electronic control unit (11) and is configured to convert the signals coming from each sensor (SI, S2, S3, S4) into a format understandable by the electronic control unit (11).

4. System (100) according to claim 2 or 3, wherein the radio frequency identification Tag (13) comprises a radio frequency communication module (131), an "Energy Harvesting" module (132), configured to exploit a magnetic field generated for communication with the external unit, and a memory (133), preferably an EEPROM memory.

5. System (100) according to claim 3, wherein the at least one sensor (SI, S2, S3, S4) of the internal unit (10) is a digital sensor and the hardware module (12) comprises an analog multiplexer (121) controlled by the electronic control unit (11).

6. System (100) according to claim 3, wherein the at least one sensor (SI, S2,S3, S4) of the internal unit (10) is a digital sensor and the hardware module (12) comprises an analog multiplexer (121) and an IC module (122), which are controlled by the electronic control unit (11).

7. System (100) according to any one of the preceding claims, wherein the internal unit comprises a flexible printed circuit board (15) to which the at least one sensor (SI, S2, S3, S4) is electrically connected and on which the electronic control unit (11), the hardware module (12), the radio frequency identification tag (13) and the antenna (14) are positioned.

8. System (100) according to claim 7, wherein the printed circuit board (15) is rectangular in shape with a length (L) ranging from about 80 mm to about 38 mm and a width (W) ranging from about 40 mm to about 14 mm and wherein the electronic control unit (11), the hardware module (12) and the radio frequency identification Tag (13) are arranged in the centre of the printed circuit board (15) following a fixed rectangular configuration, which extends longitudinally to the printed circuit board (15).

9. System (100) according to claim 7 or 8, wherein the antenna (14) of the internal unit (10) has the shape of a series of tracks (14a, 14b, 14c), which extend parallel to one another and suitably spaced at a peripheral edge of the printed circuit board (15).

10. System (100) according to any one of the preceding claims, wherein the internal unit (10) comprises a biocompatible coating, preferably constituted by a layer of parylene C.

11. System (100) according to any one of claims 2 to 10, wherein the external unit (20) includes an antenna (24), in communication with the antenna (14) of the internal unit (10) and configured to generate a magnetic field in order to provide the internal unit (10) with a start command and the energy necessary for power supply, without the use of batteries.

12. System (100) according to any one of the preceding claims, further comprising a subcutaneous intermediate station (40) for energy storage and data collection, which is located in an ideal anatomical position which minimizes itsdistance from the internal unit (10).

13. Method for monitoring an abdominal aortic aneurysm conducted by using the system (100) according to any one of the preceding claims, the method comprising the following steps of:- detecting (S2), by means of at least one sensor (SI, S2, S3, S4) of an internal unit (10) of the system (100), blood pressure and flow data inside the aneurysmal sac;- acquiring (S4), by means of an external unit (20) of the system (100), the blood pressure and flow data detected by the at least one sensor (SI, S2, S3, S4) of the internal unit (10); and- transmitting (S6) the blood pressure and flow data read to a remote server (30) through the external unit.

14. Method according to claim 13, wherein the step of detecting (S2) blood pressure and flow data comprises, for each sensor (SI, S2, S3, S4), the following substeps of:- selecting (S21) a sensor (SI, S2, S3, S4);- checking (S22) if the selected sensor (SI, S2, S3, S4) requires the detection of blood pressure and / or flow data following a detection start command previously transmitted by the external unit (20); and- in the affirmative (step S22, YES), detecting (S23) the blood pressure and / or flow data of the sensor (SI, S2, S3, S4) n times, calculating the average and saving a code indicating detection of success or error message.

15. Method according to claim 13 or 14, further comprising a preliminary step (SI) of verifying the presence of a detection start command, which includes the following steps conducted in parallel, respectively, by the internal unit (10) and by the external unit (20) of the system (100):- cyclically executing (Si l), by means of the internal unit (10), a series of readings from its own memory, to check whether there is a detection start command sent by the external unit (20);- transmitting (S12), by means of the external unit (20), a magnetic field to establish a connection to the internal unit (10);- checking (SI 3) the presence of connection; and- in the affirmative (SI 3, YES), writing (SI 4), by means of the external unit (20), specific instructions into the memory (133) of the internal unit (10); and- entering (SI 5), by the external unit (20), a constant waiting state, keeping the magnetic field active.

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