Implantable detection device for monitoring an abdominal aortic aneurysm

Abstract

An implantable detection device (100) for continuously monitoring an abdominal aortic aneurysm is described. The device comprises a printed circuit board (10), at least one sensor (S1, S2, S3, S4) for measuring blood pressure and flow within the abdominal aortic aneurysm and electrically connected to the printed circuit board (10), and an electronic control unit (12) positioned on the printed circuit board (10) and in electrical communication with the at least one sensor (S1, S2, S3, S4). The printed circuit board (10) is flexible, so that it can be folded reversibly, during implantation of the implantable detection device.

Description

[0001] “Implantable detection device for monitoring an abdominal aortic aneurysm”

[0002] Field of the invention

[0003] The present invention generally concerns the technical field of abdominal aortic aneurysm treatment. In particular, the present invention concerns an implantable detection device for 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, typically a stent, 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] Currently, implantable detection devices, which are coupled to the prosthesis, are also known for monitoring blood pressure and blood flow at an abdominal aortic aneurysm treated with endovascular prosthesis.

[0011] US patent application n. US20220167922A1 describes a sensor assembly for an endovascular prosthesis, comprising a body adapted to be coupled to the prosthesis, one or more sensors, a wireless communication interface and a power supply. In particular, the body can be one among: a body adapted to be reversibly attached and detached to / from the prosthesis, an elastic or super-elastic body having a shape that fits around the prosthesis, a spring-shaped body, a body of adjustable size, which can be adapted to the size and shape of the prosthesis.

[0012] US patent application n. US2022110710A1 describes a pressure sensor couplable to an endovascular prosthesis, for example a stent, positioned at the mouth of an aneurysm. The pressure sensor communicates wirelessly with an external device and is also supplied wirelessly, therefore eliminating the need of a rechargeable battery.

[0013] US patent n. US7955268B2 describes a pressure detection system coupled to an endovascular prosthesis, for example a stent, implanted into a blood vessel. The sensor assembly comprises a first pressure sensor coupled to a first end of the stent, a second pressure sensor coupled to a second end of the stent, a rechargeable power supply and a wireless communication device able to communicate with a remote communication device.

[0014] Although effective in terms of monitoring blood pressure and blood flow at an abdominal aortic aneurysm treated with endovascular prosthesis, the implantable detection devices of the known type briefly described above have a series of drawbacks linked to their positioning within the aneurysmal sac treated with endovascular prosthesis. First, due to their small size, their positioning via catheter can be a complex operation for the physician, and therefore costly in terms of time. Second, and still during the positioning step, those devices could get damaged, for example after the hardware components are detached from their soldering sites.

[0015] Main object of the present invention is therefore to provide an implantable detection device for monitoring an abdominal aortic aneurysm able to overcome, or at least limit, the drawbacks related to the implantable detection devices of the known type briefly described above.

[0016] More in particular, main object of the present invention is to provide an implantable detection device for monitoring an abdominal aortic aneurysm, configured so that it can be implanted at an aneurysmal sac to be monitored in a simple and quick way.

[0017] Still, another object of the present invention is to provide an implantable detection device for monitoring an abdominal aortic aneurysm, configured so as to prevent it from being damaged when positioning it within the aneurysmal sac to be monitored.

[0018] Another object of the present invention is to provide an implantable detection device for monitoring an abdominal aortic aneurysm, configured so as to fit optimally within a catheter used for positioning it within the aneurysmal sac to be monitored.

[0019] Another object of the present invention is to provide an implantable detection device for monitoring an abdominal aortic aneurysm, configured so as to allow the aneurysmal sac to be monitored at a plurality of regions, spaced from each other.

[0020] Last, but not least, object of the present invention is to provide an implantable detection device for monitoring an abdominal aortic aneurysm, configured so as to be simple to implement and which can be manufactured at competitive costs.

[0021] Summary of the invention

[0022] These and further objects are achieved by the present invention thanks to an implantable detection device for monitoring an abdominal aortic aneurysm according to independent claim 1. Further preferential characteristics and aspects of the invention are set out in the dependent claims. The invention therefore concerns an implantable detection device for monitoring an abdominal aortic aneurysm, comprising a printed circuit board, at least one sensor for measuring blood pressure and flow within the abdominal aortic aneurysm and electrically connected to the printed circuit board, and an electronic control unit positioned on the printed circuit board and in electrical communication with the at least one sensor. The implantable detection device is characterized in that the printed circuit board is flexible, so that it can be folded reversibly during implantation of the implantable detection device.

[0023] Thanks to this combination of characteristics, in particular, thanks to the flexible nature of the printed circuit board, the implantable detection device according to the invention can advantageously be implanted in a simple and quick way into the aneurysmal sac to be monitored, without damaging its electrical and electronic components. Moreover, the implantable detection device according to the invention advantageously allows the aneurysmal sac to be monitored at a plurality of regions spaced from each other.

[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 (W) ranging from about 40 mm to about 14 mm.

[0025] In an embodiment, the device further comprises a radio frequency identification Tag and an antenna, both positioned on the printed circuit board, wherein the radio frequency identification Tag is in electrical communication with the electronic control unit and communicates, through the antenna, with an external unit outside the device.

[0026] In an embodiment, the device further comprises a hardware module, which is positioned on the printed circuit board, 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.

[0027] In an embodiment, the at least one sensor is a digital sensor and the hardware module comprises an analog multiplexer controlled by the electronic control unit. Alternatively, the at least one sensor is a digital sensor and the hardware module comprises, in addition to the analog multiplexer, an IC module, wherein the analog multiplexer and the IC module are controlled by the electronic control unit.

[0028] In an embodiment, 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.

[0029] The rectangular configuration preferably has a length 1 equal to approximately 23 mm and a width w equal to about 4 mm.

[0030] In an embodiment, the antenna has the shape of a series of tracks which extend parallel to each other and suitably spaced at a peripheral edge of the printed circuit board.

[0031] 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.

[0032] In an embodiment, the at least one sensor comprises a plurality of sensors, preferably four sensors, which are positioned on a strip of conductive material, which extends longitudinally from the printed circuit board.

[0033] In an embodiment, the at least one sensor comprises four sensors, which are positioned in pairs, outside the printed circuit board, on the opposite side with respect to a transverse axis of the printed circuit board, wherein strips of conductive material extend longitudinally from the printed circuit board, each of which has a pair of branches of conductive material for the electrical connection of a respective sensor.

[0034] In an embodiment, the at least one sensor comprises a plurality of sensors (SI, S2, S3, S4), preferably four sensors, positioned outside the printed circuit board, all on the same side or the four sides of the printed circuit board and connected to it by means of respective strips of conductive material.

[0035] In an embodiment, the at least one sensor comprises a plurality of sensors, preferably four sensors, positioned inside the printed circuit board, which are aligned to each other along a longitudinal axis of the printed circuit board. In an embodiment, the device comprises a biocompatible coating preferably constituted by a layer of parylene C.

[0036] Brief description of the drawings

[0037] The invention will be described hereunder with reference to the accompanying drawings provided by way of example only and therefore not limiting, in which:

[0038] - Figure 1 is a schematic plan view of an implantable detection device for monitoring an abdominal aortic aneurysm according to a first embodiment of the present invention;

[0039] - Figure 2 is a schematic plan view of a printed circuit board of the device of Figure 1 as it switches from a wound configuration (shown on the left) to a flat or unfolded configuration (shown on the right);

[0040] - Figure 3 is a block diagram which illustrates the different components of the implantable detection device of Figure 1;

[0041] - Figure 4 schematically shows an embodiment of a hardware module of the implantable detection device of Figure 3;

[0042] - Figure 5 schematically shows an alternative embodiment of the hardware module of the implantable detection device of Figure 3; and

[0043] - Figures 6(a) to 6(d) are plan views of alternative embodiments of an implantable detection device for monitoring an abdominal aortic aneurysm according to the present invention.

[0044] Detailed description of the invention

[0045] With reference to Figure 1, an implantable detection device for monitoring an abdominal aortic aneurysm according to an embodiment of the present invention is depicted therein.

[0046] The device, generally denoted by the number of reference 100, is a miniaturized implantable detection device which, in use, is delivered into an aneurysmal sac via a catheter (not shown) of appropriate size. In particular, the catheter is positioned in the aneurysmal sac until the completion of the so-named stent grafting procedure and subsequently removed.

[0047] The implantable detection device 100 is further configured to detect, with high sensitivity, blood pressure and blood flow data inside the aneurysmal sac and transmit the pressure and flow data detected to the external unit (not shown).

[0048] For this purpose, the device 100 comprises a preferably flat printed circuit board or PCB 10 and at least one sensor, preferably four sensors SI, S2, S3, S4 for measuring blood pressure and flow within the aneurysmal sac, which are electrically connected to the printed circuit board 10.

[0049] The printed circuit board 10 is flexible so as 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 10 from the wound position to the unfolded position is shown in Figure 2, wherein the printed circuit board 10 is visible in the wound position on the left, while the printed circuit board 10 is shown in the unfolded position on the right.

[0050] Moreover, the printed circuit board 10 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.

[0051] In the embodiment shown in Figure 1, 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 11 of conductive material, which extends longitudinally from the printed circuit board 10.

[0052] The sensors SI, S2, S3, S4 can be of the active or passive type and provide pressure readings in absolute values, with an optimal measurement range of 750 mmHg to 1050 mmHg.

[0053] 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.

[0054] The SI, S2, S3, S4 sensors have a compact structure of a size which preferably does not exceed 3mmx3mmx3mm. Moreover, each sensor SI, S2, S3, S4 has limited power consumption, preferably below 1 mA. This way, the implantable detection device 100 can operate without a battery.

[0055] The implantable detection device 100 further comprises an electronic control unit 12, for example a microcontroller, a hardware module 13, a radio frequency identification Tag or RFID Tag 14 and an antenna 15, which are positioned on the printed circuit board 10 and electrically connected thereto.

[0056] In particular, the electronic control unit 12, the hardware module 13 and the RFID Tag 14 are arranged at the centre of the printed circuit board 10 following a fixed rectangular configuration, which extends longitudinally to the printed circuit board 10. Such rectangular configuration advantageously allows to prevent mechanical stress, which could occur when winding the printed circuit board 10 during the step of positioning the detection device 100 at the site of interest, and to reduce to the minimum the risk of the electronic control unit 12, the hardware module 13 and the RFID Tag 14 becoming detached from their soldering points.

[0057] The size of the rectangular configuration according to which the electronic control unit 12, the hardware module 13 and the RFID Tag 14 are arranged preferably is such that the printed circuit board 10 fits optimally inside the positioning catheter of the implantable detection device 100. In particular, the rectangular configuration has a length 1 equal to about 23 mm and a width w equal to about 4 mm.

[0058] The antenna 15 has the shape of a series of tracks 15a, 15b, 15c, which extend, parallel to one another and suitably spaced, at a peripheral edge of the printed circuit board 10.

[0059] In particular, the antenna 15 has impedance aligned with the internal tuning capacitance value of the device (Ctuning) to form a circuit which has a tuning or resonant frequency ( / timing) of about 13.56 MHz.

[0060] The essential equation for the tuning frequency is the following: where Lantenna is the inductance of the antenna 15.

[0061] As shown in detail in Figure 3, the electronic control unit 12 is in electrical communication with the sensors SI, S2, S3, S4. Communication between the electronic control unit 12 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 12 is configured to execute software instructions to monitor the sensors SI, S2, S3, S4, process the data, make decisions and manage other hardware devices.

[0062] The hardware module 13 acts as an interface between the sensors SI, S2, S3, S4 and the electronic control unit 12 and is configured to convert the signals coming the sensors SI, S2, S3, S4 into a format understandable by the electronic control unit 12.

[0063] The RFID Tag 14 is in electrical communication with the electronic control unit 12 and communicates, through the antenna 15, with the external unit. The RFID Tag 14 is configured to store data, such as serial numbers, identifiers, authentication information and other specific data, and communicates with the external unit without requiring physical contact, by exploiting the RFID (Radio Frequency Identification) technology.

[0064] The antenna 15 has the task of receiving energy and radio frequency signals, or RF signals, from an external unit, this way triggering the RFID Tag 14. In other words, the antenna 15 acts as a bridge between the RFID Tag 14 and the external unit, therefore allowing the communication of the RFID Tag 14 without requiring its own battery.

[0065] The RFID Tag 14 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 14 preferably uses the ISO 15693 communication protocol and operates at the tuning or resonant frequency ( tuning) of the antenna 15.

[0066] The RFID Tag 14 comprises a radio frequency communication module 141, or RF communication module, an "Energy Harvesting" module 142 configured to exploit a magnetic field generated for communication with the external unit, and a memory 143.

[0067] The memory 143 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 implantable detection device 100 and the external unit. Such memory is accessible via RF communication with the external unit but it is also possible to access it physically via the electronic control unit 12 by using digital communication protocols, such as I2C.

[0068] With reference to Figure 4, an embodiment of a hardware module 13, relating to an implantable detection device 100 in which digital sensors SI, S2, S,3, S4, i.e. sensors whose output is already in digital format, are implemented, is shown therein.

[0069] In such embodiment, the hardware module 13 comprises an analog multiplexer 131 controlled by the electronic control unit 12.

[0070] In particular, the analog multiplexer 131 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 12 controls the multiplexer 131 and sends, when needing to interact with a given sensor SI, S2, S3, S4, a signal (SEL) to the multiplexer 131 to select the proper communication channel.

[0071] The multiplexer 131 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.

[0072] With reference to Figure 5, an alternative embodiment of a hardware module 13’, relating to an implantable detection device 100 comprising analog sensors SI, S2, S3, S4 whose signal therefore needs to be converted into digital format, is shown therein.

[0073] In such alternative embodiment, the hardware module 13’, in addition to the multiplexer 131, comprises an IC module 132 also controlled by the electronic control unit 12. The IC module 132 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 12. The multiplexer 131 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 4.

[0074] The implantable detection device 100 is preferably provided with 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.

[0075] In a particularly preferred embodiment, the biocompatible coating is constituted by a thin layer (about 1-2 pm) of parylene C.

[0076] With reference to Figure 6, four different embodiments of the implantable detection device according to the present invention are shown therein. Such embodiments differ from the one described and illustrated above in Figures 1 to 5 in the different way of positioning the sensors SI, S2, S3, S4 for measuring blood pressure and flow within the aneurysmal sac compared with the flexible printed circuit board 10.

[0077] In the implantable detection device of Figure 6(a) generally denoted by the number of reference 1100, the sensors SI, S2, S3, S4 are four “wire-like” sensors positioned in pairs, i.e. a first pair of sensors SI and S2 and a second pair of sensors S3 and S4, outside the printed circuit board 10, on the opposite side with respect to a transverse axis of the printed circuit board 10. For such purpose, respective thin strips 111 of conductive material 112 which have two branches also of conductive material, respectively I l la and 111b and 112a and 112b, and to each of which a sensor of the pair of sensors is electrically connected, extend longitudinally from opposite edges of the printed circuit board 10. In particular, the sensor SI is connected to the branch I l la of the strip 111, the sensor S2 is connected to the branch 111b of the strip 111, the sensor S3 is connected to the branch 112a of the strip 112 and the sensor S4 is connected to the branch 112b of the strip 112.

[0078] In the implantable detection device of Figure 6(b) generally denoted by the number of reference 2100, the sensors SI, S2, S3, S4 are of the “wire-like” type and positioned outside the flexible printed circuit board 10, all on the same side. In particular, each sensor SI, S2, S3, S4 is connected to the printed circuit board 10 by means of a respective thin strip 211a, 211b, 211c, 21 Id of conductive material.

[0079] In the implantable detection device of Figure 6(c) generally denoted by the number of reference 3100, the sensors SI, S2, S3, S4 are positioned inside the printed circuit board 10, which are aligned to each other along a longitudinal axis of the printed circuit board 10. In particular, each sensor SI, S2, S3, S4 is connected to the printed circuit board 10 by means of a respective thin strip 411a, 411b, 411c, 41 Id of conductive material.

[0080] In the implantable detection device of Figure 6(d) generally denoted by the number of reference 4100, the sensors SI, S2, S3, S4 are of the “wire-like” type and positioned outside the flexible printed circuit board 10, on the four sides of the latter.

[0081] Thanks to the present invention, it is possible to have an implantable detection device for monitoring an abdominal aortic aneurysm, configured so as it can be implanted in a simple and quick way in the aneurysmal sac, without damaging its electrical and electronic components. Moreover, the implantable detection device according to the invention is configured so as to allow the aneurysmal sac to be monitored at a plurality of regions spaced from each other.

[0082] 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. Implantable detection device (100; 1100; 2100; 3100; 4100) for monitoring an abdominal aortic aneurysm, comprising a printed circuit board (10), at least one sensor (SI, S2, S3, S4) for measuring blood pressure and flow within the abdominal aortic aneurysm and electrically connected to the printed circuit board (10), and an electronic control unit (12) positioned on the printed circuit board (10) and in electrical communication with the at least one sensor (SI, S2, S3, S4); characterized in that the printed circuit board (10) is flexible, so that it can be folded reversibly, during implantation of the implantable detection device.

2. Device (100; 1100; 2100; 3100; 4100) according to claim 1, wherein the printed circuit board (10) 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.

3. Device (100; 1100; 2100; 3100; 4100) according to claim 1 or 2, further comprising a radio frequency identification Tag (14) and an antenna (15), which are positioned on the printed circuit board (10), wherein the radio frequency identification Tag (14) is in electrical communication with the electronic control unit (12) and communicates, through the antenna (15), with an external unit outside the device (100).

4. Device (100; 1100; 2100; 3100; 4100) according to any one of the preceding claims, further comprising a hardware module (13; 13'), which is positioned on the printed circuit board, acts as an interface between each sensor (SI, S2, S3, S4) and the electronic control unit (12) and is configured to convert the signals coming from each sensor (SI, S2, S3, S4) into a format understandable by the electronic control unit (12).

5. Device (100; 1100; 2100; 3100; 4100) according to claim 4, wherein the at least one sensor (SI, S2, S3, S4) is a digital sensor and the hardware module (13) comprises an analog multiplexer (131) controlled by the electronic control unit (12).

6. Device (100; 1100; 2100; 3100; 4100) according to claim 4, wherein the at least one sensor (SI, S2, S3, S4) is a digital sensor and the hardware module (13) comprises an analog multiplexer (131) and an IC module (132), which are controlledby the electronic control unit (12).

7. Device (100; 1100; 2100; 3100; 4100) according to any one of the preceding claims, wherein the electronic control unit (12), the hardware module (13) and the radio frequency identification Tag (14) are arranged at the centre of the printed circuit board (10) following a fixed rectangular configuration, which extends longitudinally to the printed circuit board (10).

8. Device (100; 1100; 2100; 3100; 4100) according to claim 7, wherein the rectangular configuration has a length 1 equal to about 23 mm and a width w equal to about 4 mm.

9. Device (100; 1100; 2100; 3100; 4100) according to any one of the preceding claims, wherein the antenna (15) has the shape of a series of tracks (15a, 15b, 15c), which extend parallel to each other and suitably spaced at a peripheral edge of the printed circuit board (10).

10. Device (100; 1100; 2100; 3100; 4100) according to any one of claims 3 to 9, wherein the radio frequency identification Tag (14) comprises a radio frequency communication module (141), an "Energy Harvesting" module (142), configured to exploit a magnetic field generated for communication with the external unit, and a memory (143), preferably an EEPROM memory.

11. Device (100) according to any one of the preceding claims, wherein the at least one sensor comprises a plurality of sensors (SI, S2, S3, S4), which are positioned on a strip (11) of conductive material, which extends longitudinally from the printed circuit board (10).

12. Device (1100) according to any one of claims 1 to 10, wherein the at least one sensor comprises four sensors (SI, S2, S3, S4) which are positioned in pairs, outside the printed circuit board (10), on the opposite side with respect to a transverse axis of the printed circuit board (10), wherein strips (111, 112) of conductive material extend longitudinally from the printed circuit board (10), each of which has a pair of branches (I l la, 111b, 112a, 112b) of conductive material for the electrical connection of a respective sensor.

13. Device (2100; 4100) according to any one of claims 1 to 10, wherein the atleast one sensor comprises a plurality of sensors (SI, S2, S3, S4) positioned outside the printed circuit board (10), all on the same side or on the four sides of the printed circuit board (10) and connected to it by means of respective strips (211a, 211b, 211c, 21 Id; 411a, 411b, 411c, 41 Id) of conductive material.

14. Device (3100) according to any one of claims 1 to 10, wherein the at least one sensor comprises a plurality of sensors (SI, S2, S3, S4) positioned inside the printed circuit board (10), which are aligned to each other along a longitudinal axis of the printed circuit board (10).

15. Device (100; 1100; 2100; 3100; 4100) according to any one of the preceding claims, comprising a biocompatible coating preferably constituted by a layer of parylene C.

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