Angiogenesis System

Abstract

An angioplasty system (1) is provided, which includes an expansion device for an angioplasty device in a blood vessel exhibiting a stenosis, a contrast agent reservoir (2) with a pressure regulating device, connectors (4, 5), a pressure sensor (6), an electronically actuated valve (7), safety means (10), power means, a digital interface, a microprocessor with a first software, a memory, means for connecting the microprocessor to the Internet or an intranet, a second artificial intelligence software, a database (20), and a radiation arch (30) for acquiring and processing images of the blood vessel or the area in which the blood vessel is located. The microprocessor is connected to the radiation arch and the database, and the expansion device can learn to operate autonomously and adjust automatically, taking into account previous data or treatment models.

Description

[Technical field]

[0001] The present invention relates to the technical field of materials used in the angioplasty or dilation process of blood vessels exhibiting stenosis. More specifically, the present invention relates to angioplasty systems. The present invention also refers to procedures for angioplasty and dilation devices, such as balloons or balloon-mounted stents, in particular with automatic adjustment and artificial intelligence. [Background technology]

[0002] Currently, catheter-based techniques for treating narrowed blood vessels involve either dilating the blood vessel with a ball or balloon or dilating the blood vessel with a balloon-mounted stent, a procedure known as percutaneous transluminal angioplasty (PTA).

[0003] It can be said that PTA consists of the phases of inflation, plateau or stability, and contraction, and the most commonly used device for pressure delivery is a manual pressure syringe equipped with a pressure gauge that allows the operator to visually control the inflation pressure of the balloon. In the inflation phase, the pressure increases. In the plateau phase, the nominal pressure is reached according to the specifications of the angioplasty device (balloon or balloon-mounted stent). Finally, in the contraction phase, a decrease in the balloon pressure is seen.

[0004] Side effects of these types of treatments include elastic recoil (or recoil), vessel dissection, and restenosis.

[0005] Elastic recoil is the return to the initial state. Dissection, on the other hand, consists of partial fragmentation of the diseased arterial wall and its detachment towards the vessel lumen against the blood flow wave. The total expansion time is important for the vessel to heal from the barotrauma that leads to said dissection. At the same time, residual stenosis or insufficient lumen increase may occur due to insufficient pressure and / or treatment time. Finally, restenosis due to scar reaction against the vessel lumen may require a new treatment.

[0006] Due to the difficulty in identifying the variables that cause elastic recoil and dissection, the interventional community has primarily opted for mechanical support through stent implants, a solution designed primarily for coronary angioplasty procedures.

[0007] However, in the arteries of the lower limbs, where stents do not function properly, a stentless dilatation balloon solution is employed.

[0008] With the architecture of balloon technology well developed, research groups are now focusing on how to deliver the pressure needed to the blood vessel to overcome the stenosis.

[0009] Thus, inflation and deflation speeds, total treatment time, and maximum inflation pressure are variables to consider today, and angioplasty must be performed in a precise, reproducible, and modifiable manner. To that end, computer-assisted inflation solutions have been proposed. Their aim is to try to avoid the variability of manual treatment by standardizing the PTA procedure and making it reproducible.

[0010] These computerized solutions are supported by pressure electric pumps and are programmable for all treatment phases, but they have a major drawback in that once the treatment parameters have been entered and treatment has begun, they cannot be changed without interrupting the automation of the treatment.

[0011] Other authors have demonstrated how the behavior of the pressure-volume curve or behavior based on the pressure-diameter curve provides sufficient information in real time to explain and predict desirable or undesirable events occurring from the start of the expansion phase to the end of the plateau.

[0012] Thus, the inability to control variables and difficult to recognize events that occur during PTA, along with other drawbacks, have prevented the development and generalization of these computer-assisted dilation devices described over 20 years ago.

[0013] US Pat. No. 5,399,433 and US Pat. No. 5,499,441 are cited as examples of the state of the art.

[0014] Patent Document 1 describes an expandable intraluminal system, method, and device related to realizing improved tissue response to dilatation or other tissue dilatation procedures, in which a treatment program including dilatation-contraction cycles with a predefined frequency profile is defined and configured to treat a specific condition such as calcification of the ductus arteriosus is defined. However, in this case, the device is configured to cause stretching or dilatation of mammalian tissue and / or blood vessels in a cyclical pattern based on the Mullins effect by preprogramming, but the behavior of diseased blood vessels during dilatation by an angioplasty device with or without a stent does not depend only on the Mullins effect, and the device cannot deal with various situations that may occur because it responds to a fixed and predefined programming in all phases before starting each treatment.

[0015] US Pat. No. 5,399,633 defines a method performed by a motorized inflation device to prepare a balloon catheter for use during a medical procedure. The method includes drawing a certain amount of medical fluid from a fluid reservoir into the inflation device during a first motorized operation of the inflation device, removing a certain amount of air from the balloon catheter during a second motorized operation of the inflation device, and injecting a certain amount of medical fluid into the balloon catheter during a third motorized operation to inflate a balloon located at the distal end of the balloon catheter. In one embodiment, the motorized inflation device is connected to an angiography injector system, and the balloon inflation device and the injector system can be controlled by a common control panel or console. Similarly, the system is programmable based on inputs formed by feedback loops of pressure or pressure fluctuation data. These loops are thus the sudden pressure drops present during the procedure, which are due to the accumulation of yielding plaque, which is the ultimate goal of the procedure. In this case, the computer is programmed to be able to detect, thanks to these sensors, the feedback information to perform a "desired" action (e.g., to deflate the balloon or to keep the balloon inflated for a certain time) defined before the start of the treatment.

[0016] Current technological developments provide increased computational power, connectivity, and machine learning, all of which can address the complexity of diseases and the behavior that blood vessels and tissues (with or without disease) exhibit when exposed to high pressures during these types of treatments.

[0017] The application of these developments and the availability of systems capable of completely and intelligently mechanizing treatment procedures operating within safety limits and at the same time ensuring the best possible outcome of the treatment would be a major step forward for vascular surgical interventional techniques. [Prior art documents] [Patent documents]

[0018] [Patent Document 1] US Patent Publication No. 2020094018 [Patent Document 2] US Patent Publication No. 2009312740 Summary of the Invention

[0019] To that end, an embodiment of the present invention provides an angioplasty system according to a first aspect. The proposed system comprises an expansion device for expanding an angioplasty device in a blood vessel exhibiting a stenosis. In particular, the expansion device comprises a reservoir of contrast agent equipped with a pressure regulating device, a connector for connection to the angioplasty device connected to the reservoir via a disposable tube, a pressure sensor arranged in the reservoir, and an electronically actuated valve for controlling the inflow or outflow of the contrast agent. Furthermore, the expansion device comprises safety means for emergency deflation of the angioplasty device, power supply means, and a digital interface for input of, for example, values / data and machine learning algorithms.

[0020] The inflation device then includes a microprocessor connected to the electronically operated valves and the pressure regulating device and having first operating software for controlling operating parameters of the inflation device and having at least one operating application for remote management, a memory connected to the microprocessor, and a means for connecting the first operating software to the Internet or an intranet.

[0021] The system further includes a second artificial intelligence software operatively connected to the first operating software for automatic self-learning of the expansion device and including a means for connecting to the Internet, a database operatively connected to the Internet or an intranet for storing data or treatment models including management software, and a radiation arch for imaging / acquiring and processing images of the area in which the blood vessel or blood vessel to be treated is located, as well as the amount of contrast agent circulating therein.

[0022] In particular, the microprocessor is operatively connected to the radiation arch and database so that the expansion device can perform a learning process to operate autonomously and automatically adjust using previous data or treatment models.

[0023] According to the present invention, the second artificial intelligence software may include, for example, neural networks, deep learning algorithms, clustering algorithms, and / or decision trees, etc. This second software may be implemented / executed in the radiation arch itself (i.e. in the arch console), in the expansion device itself (i.e. by a microprocessor), or in a computing device separate or independent from the radiation arch and the expansion device. In particular, the second software is used to obtain the data or treatment model stored in the database. For that purpose, the second software uses the information processed by the radiation arch or parts thereof, the operational data from the expansion device itself, and, if available, data from the database itself.

[0024] In some embodiments, the system also comprises a means for heating the contrast agent.

[0025] In some embodiments, the pressure regulating device comprises an electric pump.

[0026] In some embodiments, the safety means for emergency deflation comprises a vacuum reservoir connected to the reservoir. Additionally, the safety means may also include a manual safety means.

[0027] In some embodiments, the disposable tube connected to the reservoir includes two or more branches, each branch including a connector for connection to a different angioplasty device.

[0028] In some embodiments the power supply means comprises a battery or a connection to a power grid.

[0029] In some embodiments, the microprocessor connection means includes a connection interface installed on the expansion device or a connection to an external electronic device running a corresponding application.

[0030] In some embodiments, the digital interface also includes a communication port for QR code reader or wireless data entry.

[0031] An embodiment of the present invention provides, according to a second aspect, an angioplasty procedure comprising providing an expansion device similar to that described above; providing a database for storing data or treatment models, the database being operatively connected to an internet or an intranet and including management software; providing second artificial intelligence software; acquiring and processing one or more images of the blood vessel or an area in which the blood vessel is located by a radiation arch operatively connected to a microprocessor; and autonomously and automatically operating and adjusting the expansion device according to previous data or treatment models stored in the database and obtained by running the second artificial intelligence software on at least the data processed by the radiation arch and the data from the expansion device acquired by the first software.

[0032] Embodiments of the present invention also provide, according to a third aspect, an expansion device for expanding an angioplasty device in a blood vessel exhibiting a stenosis. The device of the third aspect may include various elements and software as described above in the first aspect of the invention.

[0033] Thus, the present invention significantly improves on state-of-the-art devices by allowing automatic adjustment of the dilation device and including artificial intelligence, since the dilation device allows the angioplasty procedure to be performed completely autonomously and, thanks to artificial intelligence, does not need to take into account the large number of unknown variables involved. The presence of these variables is the reason why current programmable automatic devices have not been accepted into practice among therapists, despite their accuracy and reproducibility. By using the proposed dilation device, it is possible to omit all these variables and focus on identifying successful treatment patterns, so that they can be accurately reapplied when facing the same situation in future treatments.

[0034] To achieve automatic adjustment during treatment, dynamic changes in pressure, volume and diameter during inflation, the plateau phase and finally deflation are analysed and accommodated.

[0035] Actions that trigger the inflation device to automatically adjust are purging of air, a rupture of the angioplasty device, an occlusion, and a pressure drop due to a sudden distortion of the vessel. Since air and any gas are compressible, purging of air allows the inflation device to detect the presence of gas by a change in volume and pressure. After refilling the syringe with liquid and closing the inlet and outlet systems, the inflation device will attempt to fill and / or drain. If there is no air in the system, a pressure change will occur but not a volume change. On the other hand, if there is air in the system, a volume change will occur along with a pressure change. The inflation device will automatically request a change in position, then drain the air and perform the verification again until there is no gas in the system.

[0036] If a sudden pressure drop occurs due to angioplasty device rupture, the inflation device will automatically attempt to compensate by increasing volume: if there is no response by restoring pressure, a leak has occurred and the inflation device will stop treatment and warn of the event.

[0037] Conversely, occlusion means that volumetric changes due to increases or decreases in pressure are not possible without overcoming the nominal pressure of the angioplasty device or without contraction, and when faced with a pressure drop due to sudden strain on the vessel, the inflation device will continue or resume inflation until it reaches and maintains the nominal inflation pressure of the device.

[0038] The inflation device is fully automatic, so once the procedure has begun it will run without operator intervention, however in certain circumstances it can be programmed to require operator confirmation during some phases of treatment.

[0039] Thus, the invention allows the expansion device to automatically adjust based on the initial data obtained during the pre-treatment, as well as on the data obtained during the treatment and in real time. Furthermore, the expansion device is equipped with artificial intelligence and, thanks to the connection with the radiation arch that takes and processes the images, can receive the feedback information necessary for machine learning. This connection with the arch allows the machine learning process to be carried out and can be equipped with artificial intelligence.

[0040] Image processing allows a preliminary anatomical survey of the area to be treated, since the anatomical bone structures are characteristic of each area and are opaque to radiation, allowing the device to always recognize them, thanks to the microprocessor connected to the radiation arch, once machine learning has enabled them to be identified.

[0041] Because pathology often exhibits repeating patterns with variability existing between patients, there may be a diverse set of effects based on the area being treated, which is critical information for machine learning of expansion devices.

[0042] Another aspect that is achieved is the measurement of the vessel lumen, since automatically after the initial acquisition, the dilatation device can distinguish between luminal areas with larger or smaller diameters and the length of the stenosis. This information is very important for the correct selection of the dilatation device according to diameter and length, and for analyzing the results during the machine learning of the dilatation device.

[0043] The next parameter to be achieved is the measurement of flow rate, because, knowing the diameter of the angioplasty device, the amount of contrast agent administered, and the parameters of the digital subtraction (images per second, pixels, etc.), it is possible to calculate the flow rate through the target area of ​​the vessel before and after treatment. A significant increase in flow rate after treatment (the latter being uniform along the treated vessel) represents a positive reinforcement, and the treatment pattern is recalled and used in future identical or similar cases. If the increase in flow rate is insufficient, the dilation device recommends further treatment or the therapist needs to evaluate alternative treatments.

[0044] The parameters obtained during the processing of the images and the data learned by the device are shared and stored in the aforementioned database, so that medical personnel benefit from the most effective treatment patterns that are eventually added to the database after the machine learning of the dilation device. In this way, all medical personnel have access to the best and most effective treatment patterns for their respective situations, without knowing any source other than the database itself linked to the dilation device.

[0045] First, there may be a learning period during which the vascular interventionalist community can collaborate before the system / device itself has sufficient data on patients and treatments performed.

[0046] In some exemplary embodiments, the database may be located in the cloud and may use or be managed by big data techniques. From the data available in the database (i.e., previously performed procedures), treatment curve models for all possible cases are generated, and from those available, the microprocessor of the expansion device selects the most suitable model for each new case as the treatment conditions of a particular model are repeated.

[0047] Once sufficient data from performed and successful treatments has been accumulated, the data is included in a database, the purpose being to obtain the ideal pressure / diameter or pressure / volume treatment curve for each case and each situation. In some exemplary embodiments, the performed and completed data or treatment models are stored in the memory of the inflation device, allowing the microprocessor to locally select the most appropriate one without the need to interact with a database.

[0048] In this way, it is possible to obtain an expansion device for an angioplasty treatment device, which allows a greater accuracy of operation to be achieved and makes it possible to act on the patient according to data obtained from experience, and in particular to change the type of intervention based on fluctuations in this data that may occur during the execution of the angioplasty process itself, depending on the specific variables of the patient and the stenosis that he presents.

[0049] Since the tissue of blood vessels is irregular, with softer parts, more or less calcified parts, more or less affected by disease, etc., the tissue may react differently, even when faced with the same stenosis characteristics, and may act appropriately during and after the angioplasty procedure, or, on the contrary, may rupture, narrow again after the removal of the angioplasty device, or have other reactions that require a new treatment. With the expansion device, any change in the normal expansion, plateau and deflation procedure is detected by the software as an anomaly, and the device can react automatically by microprocessor commands that modify the treatment, searching for the most appropriate option to solve said anomaly based on the experience of other similar cases. Furthermore, thanks to the data obtained from experience, it is possible to control values ​​such as air pressure, expansion, plateau and deflation times, the speed to reach each of said states, etc. Currently, it is not possible to control all these values, so even if there are programmable or automatic devices, there are no devices that can automatically react and adjust when faced with changes in the patient's condition. On the other hand, the expansion device proposed here is able to adjust the treatment conditions after initiation.

[0050] On the other hand, the present invention solves the existing problems when performing angioplasty treatment of the vessels of the lower limbs, since it provides a lot of information about the behavior of the artery and therefore makes it possible to control the maximum treatment time required without adversely affecting the vessel. Likewise, by weighting the importance of other variables such as the total time, the time of each phase, the duration of the treatment, the area and diameter obtained, the difference between the maximum diameter before contraction and the final diameter of the vessel, the difference in the pressure gradient before and after the treatment, or the difference in the dynamic images obtained before and after the completion of the treatment, or the difference in information obtained by ultrasound of the spectral analysis of the flow curves before and after the treatment, it is possible to determine the optimal pressure of the treatment for each case, without the need to reach a nominal pressure.

[0051] The above and other features and advantages will be more fully understood from the following detailed description of several illustrative, by way of example only, non-limiting embodiments, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0052] [Figure 1] FIG. 1 is a schematic diagram of an angioplasty dilation device with self-adjustment, according to one embodiment of the present invention. [Diagram 2] FIG. 1 shows a schematic diagram of an embodiment of the proposed system. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0053] Figure 1 shows a preferred embodiment of the expansion device (1) of the present invention. The expansion device (1), or simply device (1), is used / works together with a database (20) and a radiation arch (30) (see Figure 2).

[0054] The device (1) in this example comprises, as shown in the figure, a reservoir (2) of contrast agent with a pressure regulating device (3), for example formed by an electric pump, two connectors (4, 5) connected to the reservoir (2) via disposable tubing, each for connection to an angioplasty device, a pressure sensor (6) and an electronically actuated valve (7) for controlling the inflow or outflow of the contrast agent.

[0055] By including the two connectors (4, 5), the device (1) is able to safely treat blood vessels that currently present many complications. Thus, if angioplasty needs to be performed in a complex area, for example, when a blood vessel presents a stenosis but is too close to another blood vessel, the expansion of the vessel to be treated by the inflation of the angioplasty device in the vessel may affect the neighboring vessel, since plaque may move towards it and occlude it. Currently, to solve this problem, three personnel are needed, one of them to inflate the first angioplasty device in the first blood vessel, another to inflate the second angioplasty device in the second blood vessel, and the third to hold both angioplasty devices. This method of working is very complex, since it requires the perfect synchronization of all three people participating in the process, which is highly dependent on the human factor in such a delicate process. Thus, by using the device (1), it is possible to automatically perform the inflation of both angioplasty devices, control the values ​​of both, and react instantly to any unexpected event that may occur in either angioplasty treatment. The device (1) can resolve these unexpected events by modifying variables such as inflation time, pressure and / or volume and steps to follow based on the behavior of each vessel. In any case, it is noted that in other examples not shown, the device (1) comprises a single connector.

[0056] On the other hand, the device (1) is provided with safety means for emergency deflation of the angioplasty device. In this preferred embodiment of the invention, these means are formed by a vacuum reservoir (9) connected to a reservoir (2) actuated by a safety valve. Furthermore, in this embodiment, the safety means comprise manual safety means (10) for releasing the pressure of the pressure fluid. In other embodiments, the safety means may be of one type.

[0057] The device (1) also comprises a digital interface (8) for example for data / value input, which allows manual input of treatment parameters by an operator. In this preferred embodiment of the invention, the device also comprises a communication port for data input by a QR code reader or wirelessly.

[0058] The device (1) also comprises power supply means, which in this case are formed by a connection to a power grid, however, in other embodiments they may also be formed by a battery.

[0059] The device (1) also comprises a microprocessor for controlling its operating parameters and a memory connected to the microprocessor. The microprocessor is connected to the electronically actuated valve (7) and to the pressure regulating device (3) and comprises a first operating software with at least one operating application. Means for connecting the first operating software to the Internet or an intranet are also included. The microprocessor is connected to a radiation arch intended to perform the acquisition and processing of images of the area to be treated.

[0060] In this preferred embodiment of the invention, the connection means of the first operating software to the Internet or an intranet are formed by a connection interface installed on the device (1), however, in other embodiments these connection means may also be formed by a connection to an external electronic device offering a corresponding application.

[0061] In some exemplary embodiments, the behavior of the pressure / volume curve provides the necessary information to perform automatic adjustment of the device (1). Based on the initial parameters, the microprocessor can select a treatment curve model from those available in the database, particularly from those with the best historical results.

[0062] During treatment, automatic adjustment of the device (1) consists in the microprocessor, based on the behavior of the pressure / volume curve, choosing, for example, whether to continue with the initial model, to automatically change the model, to ask the operator for confirmation to continue, or to proceed with the deflation and interrupt the treatment.

[0063] Also included is a second artificial intelligence software with means of connection to the Internet or to the first operating software for self-learning optimal processes. This second software has the main function of enabling the device (1) to extract data and conclusions from all past experiences collected in a database, particularly in the cloud, during the initial use phase of the device (1). In any case, if the device (1) itself already contains all the information related to said experiences, it can stop using the information contained in the database, if necessary, because that information is already available in the memory and therefore already available to the first operating software itself.

[0064] In some examples, the device (1) may include a means for heating the contrast agent.

[0065] Now, regarding the angioplasty procedure, in an exemplary embodiment, the angioplasty procedure comprises the following steps: first, a pretreatment is performed to obtain the stenosis characteristics in the patient's blood vessel, after which a treatment is performed in said vessel, comprising the steps of dilating, stabilizing or plateauing, and contracting the device (1). Pretreatment, as known in the state of the art, consists of premedication with anticoagulation and anticoagulation at the operator's discretion. Then, an entry port for the device or a short or long guide sheath is made, the end of which is placed as close as possible to the stenosis or occlusion to be treated.

[0066] The choice of which stenosis(s) or occlusion to treat is up to the operator. A system is needed to objectively measure the results of PTA during the procedure. Moreover, said measurement system must be reproducible, since there are undesirable early results, but no immediate or delayed results. Three methods can therefore be implemented for the measurement of stenosis. The first method is to measure the pressure gradient, which has the disadvantage that, in addition to the puncture required for treatment, a second puncture must be made distal to the lesion to accommodate the measuring catheter, which measures the pressure proximally or on the side of the lesion closest to the guide sheath. The second method, which is the most commonly used, is to measure the anatomical gradation of the stenosis after the injection of contrast agent and digital subtraction angiography. The location of the lesion must be registered with an anatomical reference. Long angioplasty balloons are often chosen in cases of multiple consecutive stenoses or in the treatment of a single but long lesion. In addition to the higher percentage of narrowing, the length of the lesion must also be taken into account. Images are acquired in at least two projections before and after PTA, and while performing PTA with the balloon inflated. The second method is used because the inflation device of this preferred embodiment of the invention can receive information from a radiation arch that acquires and processes the images. The third method is the use of intravascular ultrasound (IVUS), which can measure both anatomical and hemodynamic gradations, the latter being indirect. For this reason, it is an attractive method, but needs to be validated before it can serve as the sole measure of outcome.

[0067] In either case, general and specific images of the area to be treated, as well as a series of images, are recorded.

[0068] Once preparation has been performed and the necessary data regarding the patient's stenosis has been obtained, the angioplasty procedure is performed using the device (1), which comprises a series of phases which are described below.

[0069] The first phase involves obtaining anatomical and hemodynamic information from the digital subtraction arch by the device (1) (anatomical area, inner diameter of the vessel, length of the lesion, flow rate through the vessel, and total flow rate in the examined area). The second phase involves connecting the device (1). Then the third phase involves filling the reservoir (2) with the appropriate liquid and purging the air.

[0070] Specifically, when purging air, the following process is followed: - A checklist of the previous steps required is verified using the digital interface (8) and information is requested. - The therapist immerses the extension end in order to fill the container with the desired contrast medium. Once this action is confirmed, the device (1) starts the automatic filling of the reservoir (2) to its maximum capacity by a motorized counterclockwise movement of the piston. At this point the motor begins a short reverse rotation, i.e. clockwise, to remove any air that may have been trapped and to discard a small amount of liquid. -The device (1) asks the therapist to mechanically close the contrast entry and exit port and starts checking for the presence of gas in the system. Due to the small recoil or filling action of the piston, the pressure gauge detects if there is a change in pressure and if a change in volume occurs in different scenarios. If the pressure in the reservoir (2) decreases and the volume increases, it means that the system is airtight and there is gas inside. If the pressure is stable and the volume in the reservoir (2) increases, it means that the system is not airtight and fluids and / or gases are entering. If there is no change in volume and the pressure decreases, the system is airtight, meaning no gas is present. - The device (1) repeats this procedure until it is airtight and free of gas.

[0071] A fourth phase is then performed, which confirms the correct placement of the angioplasty device. The anatomical structure has been previously inspected and associated data has been acquired regarding the hemodynamics or flow through the diseased vessel and the area to be inspected. At this point, the ratio between the length of the device (1) and the length of the diseased portion of the vessel to be treated is important.

[0072] Once this verification is completed, a fifth phase is performed in which the device (1) calculates both the inflation rate, which is based on the ratio between the pressure increase and the volume, and the deflation rate. Similarly, the device (1), by virtue of its connection with the radiological arch, is also able to measure the diameter of the angioplasty device, which has been inflated with radiological contrast agent at various pressures until a nominal pressure is reached, and also to relate it to the delivered volume. In real-time analysis, curves relating these treatment parameters are generated: pressure-diameter, pressure-volume, and volume-diameter.

[0073] Finally, the procedure has a sixth phase that auto-adjusts the expansion device (1) based on the events that occur when the blood vessel is expanded (breakage, plaque sliding, distortion of the outer layer and surrounding tissue, elastic recoil). This auto-adjustment phase is performed in particular as follows: - Inflation of the angioplasty device begins and remains constant until a certain pressure P1 is reached. If the procedure is interrupted at this point, the situation will be the same as it was at the beginning. -When pressure P1 is reached, the plaque breaks, moves slightly and settles, creating space to inflate the balloon or angioplasty device. Stopping the procedure at this point would result in the detachment or separation of the plaque that has entered the vessel lumen without gaining an increase in its internal diameter. In the pressure-volume curve, this translates into a sawtooth shape where the curve becomes vertical and then the pressure drops slightly as the volume increases. Thus, the device (1) identifies the event and can register it to include it in the relevant information for machine learning. -When a higher pressure or P2 is reached, the strain between the outer layer of the vessel and the surrounding tissue begins. This is reflected in the flattening of the pressure-volume curve, which is always repeated at similar pressures, since it is an unavoidable and necessary event. The device (1) contains the information corresponding to the machine learning. If the expansion stops at any point between P2 and the beginning of the plateau phase, a more or less, but temporary, increase in the lumen is obtained, since the pressure P3, which exceeds the strain limit between the outer layer of the vessel and the surrounding tissue during a sufficient time of the plateau phase, has not been reached. -By reaching a pressure P3 close to the nominal pressure of the balloon inflation and maintaining it throughout the plateau phase, it is possible to overcome the strain limits of the outer layer and surrounding tissue. If deflation occurs before the end of a sufficiently long plateau phase, elastic contraction or recoil may also occur due to the hematoma formed in the outermost layer of the vessel. In this case, some "healing time" is required once the balloon is deflated, and for several minutes to hours thereafter, in order for the hematoma to stop, spread and not compress the recently gained lumen. The longer the duration of the plateau phase, the greater the success and durability of the procedure, although with limitations, since prolonged stagnation can lead to thrombosis. During the plateau phase, a small pressure drop can occur as bending of the outer layer of the blood vessel and the surrounding tissue is achieved, causing the structure to collapse and lose its elastic capacity. This phenomenon occurs even when the angioplasty device is a balloon-mounted stent, and has been shown to have a detrimental effect on the treatment outcome. The device (1) is capable of detecting pressure variations of 0.05 atm and, in a programmed manner, immediately corrects the situation in this case, if a pressure drop occurs, by resetting the selected pressure of the plateau phase. The device (1) is able to perform this correction with much greater sensitivity, speed, and precision than is currently done by humans. - The speed of contraction is also important when it comes to the outcome of these types of interventions. Counterintuitively, for reasons that are still unclear, faster contractions result in less dissociation than slower contractions. The device (1) can "learn" the contraction patterns that produce the best results after training by supervised machine learning. In this and other cases, the device (1) also serves as an aid to deepening knowledge of the pathophysiology involved in the angioplasty process or intraluminal balloon dilation of narrowed blood vessels.

[0074] The scope of the present invention is defined in the appended claims.

Claims

1. 1. An angiogenic system comprising: - a dilation device (1) configured to dilate an angioplasty device in a blood vessel exhibiting a stenosis, a reservoir (2) of contrast medium containing a pressure regulating device (3); at least one connector (4, 5) for connecting to the angioplasty device via a disposable tube connected to the reservoir (2); a pressure sensor (6) in said reservoir (2); an electronically actuated valve (7) for controlling the inflow or outflow of said contrast agent; a safety means for emergency deflation of said angioplasty device; power supply means for the inflation device (1); a digital interface (8); a microprocessor controlling a number of operating parameters of the inflation device (1), the microprocessor being operatively connected to the electronically actuated valve (7) and the pressure regulation device (3), the microprocessor including first operating software with at least one operating application intended for remote management of the inflation device (1); a memory connected to the microprocessor; means for connecting said microprocessor to the Internet or an intranet; an inflation device (1) comprising: - a second artificial intelligence software for automatic self-learning of the inflation device (1), said second software including said means of connection to the Internet and operatively connected to said first operating software; a database (20) adapted to store data or treatment models, operatively connected to said Internet or Intranet, and including management software; a radiological arch (30) adapted to acquire and process one or more images of said vessel or of the region in which said vessel is located; Equipped with The angioplasty system, wherein the microprocessor is operatively connected to the radiation arch (30) and the database (20), and the dilation device (1) is capable of performing a learning process to operate autonomously and adjust automatically.

2. The system of claim 1 further comprising a means for heating the contrast agent.

3. The system of claim 1, wherein the pressure regulation device (3) comprises an electric pump.

4. 2. The system according to claim 1, wherein the safety means comprises a vacuum reservoir (9) connected to the reservoir (2).

5. 5. The system of claim 4, wherein the safety means further comprises a manual safety means (10) for releasing the contrast pressure.

6. 10. The system of claim 1, wherein the disposable tube connected to the reservoir (2) comprises two or more branches, each branch including a connector for connecting to a different angioplasty device.

7. The system of claim 1 , wherein the power supply means includes a battery or a connection to a power grid.

8. 2. The system of claim 1, wherein the connection means to the microprocessor comprises a connection interface installed in the inflation device (1).

9. 10. The system of claim 1, wherein said connection means of said microprocessor includes a connection to an external electronic device running a corresponding application.

10. 2. The system of claim 1, wherein the digital interface (8) also comprises a communication port for QR code reader or wireless data entry.

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