Training apparatus for an endovascular surgical intervention

Abstract

The present invention relates to a training apparatus (1) for an endovascular intervention on a patient. The training apparatus (1) comprises: a simulation block (5), which is made of a material having a first refractive index (m) and comprises at least one internal cavity (11) configured to simulate a blood vessel of said patient, a supply apparatus (6) adapted to supply at least one of a first fluid (Fi) having a second refractive index (m) and / or a second fluid (F2) inside said internal cavity (11), said second fluid (F2) having a third refractive index (ns), a light radiation source (8) in such a way as to emit light radiation towards said simulation block (5), image acquisition means (9) configured to acquire images of at least the simulation block (5) and image display and recording means (10) configured to display the images acquired by the image acquisition means (9).

Description

[0001] TRAINING APPARATUS FOR AN ENDOVASCULAR SURGICAL

[0002] INTERVENTION

[0003] Cross-Reference to Related Applications

[0004] This Patent Application claims priority from Italian Patent Application No. 102024000026223 filed on November 21, 2024, the entire disclosure of which is incorporated herein by reference.

[0005] Technical Field

[0006] The present invention relates to a training apparatus for any endovascular intervention aimed, for example, and not exclusively, at the treatment of arterial or venous malformations such as stenosis (or narrowing) or aneurysm (dilation) of a blood vessel. The present invention finds a preferred, although not exclusive, application in an apparatus for the training of medical operators for endovascular surgery interventions for the treatment of cerebral aneurysms. An application to which the following discussion will make explicit reference, without thereby losing its general scope.

[0007] State of the Art

[0008] As is known, an aneurysm is an abnormal and permanent dilation of a section of a wall of a blood vessel, for example of an artery or a vein. Aneurysms are classified based on their location within the body, for example an aneurysm that occurs in the aorta is known as an aortic aneurysm, while an aneurysm that occurs in the blood vessels that supply blood to the brain is known as a cerebral aneurysm. Cerebral aneurysms are characterised by the formation of a sac (also called an aneurysmal sac) while aneurysms of the aortic tract are predominantly fusiform in nature.

[0009] The dilated section of the blood vessel wall undergoes a progressive weakening over time which is accentuated by the hemodynamic pressure exerted on it. The progressive weakening of the dilated wall section may result in the rupture of the blood vessel, that is, a rupture of the aneurysmal wall, thereby causing a hemorrhage that can lead to serious consequences for the patient, even death.

[0010] To date, interventions are performed to treat an aneurysm both by means of open surgery and by means of endovascular surgery techniques.

[0011] Compared to open surgery, endovascular surgery techniques offer several advantages, including being minimally invasive, guaranteeing shorter recovery times and generally minimising the risks associated with the intervention, for which reason the trend of preferring to treat many clinical cases endovascularly rather than by open surgery appears to be confirmed. Known endovascular surgery techniques provide for, depending on the type of aneurysm to be treated, positioning at the aneurysm, by means of catheters and microcatheters, endovascular flow diverter devices, such as a metallic mesh tube (stent), a stent-graft or metallic coils (coils) made of platinum. The devices used may vary in cases where an intervention is performed on an aortic aneurysm rather than on a cerebral aneurysm; for the sake of simplicity, hereinafter reference is made to cerebral aneurysms and the related treatment methods.

[0012] For example, to treat cerebral aneurysms, it is a widespread practice to insert a catheter into a patient's blood vessel at the groin, traverse the patient's arterial system to reach the aneurysm present in the brain, and then release the endovascular device at the aneurysmal sac.

[0013] In this way, the endovascular device restores the natural blood flow in the vessel, diverting it from the dilation of the same blood vessel, in such a way as to reduce the circulation and the blood pressure exerted against the weakened walls of the blood vessel and thereby favour the coagulation of the blood inside the aneurysmal sac.

[0014] A further endovascular surgery technique for cerebral aneurysms, also known as the “Woven EndoBridge” technique, provides for the use of a self-expanding spherical-metallic structure as an endovascular flow diverter device.

[0015] Also in this case, the self-expanding metallic structure is released inside the aneurysmal sac through a catheter inserted into the patient's blood vessels.

[0016] The endovascular surgery techniques described above present considerable difficulties, such as navigation through the blood vessels, limited visibility or the risk of complications. In particular, so as not to compromise the success of the intervention, it is necessary to position the endovascular device in the correct position at the aneurysm, in order to correctly divert the blood flow and not risk further damaging the weakened blood vessels.

[0017] During the endovascular surgery intervention, the endovascular surgeon / radiologist inserts the endovascular device into the patient's blood vessel by means of a catheter and simultaneously monitors on a screen the correct positioning of the endovascular device within the vascular system through fluoroscopy. Fluoroscopy is a radiological technique that allows images of the patient's internal anatomy to be acquired and displayed in real time through the use of a fluoroscope. In greater detail, fluoroscopy provides for the use of an X-ray source, a fluorescent screen and a digital video camera, so as to record and display the obtained images on a monitor in real time.

[0018] In particular, the patient is positioned between the fluorescent screen and the X-ray source, so that the operator can monitor in real time by means of the images displayed on the monitor the movement and positioning of the endovascular devices in the patient's vessels throughout the surgical intervention. In light of the above, the operator must be endowed with excellent manual skills and a detailed knowledge of the patient's vascular anatomy.

[0019] To date, several training apparatuses are on the market to simulate the endovascular surgery techniques described above and to train the manual skills of the operator.

[0020] In particular, the expression “training apparatus” relates to a set of tools and materials used for the training of the operator's manual skills according to the type of surgical intervention. In fact, the training apparatuses are designed to simulate real surgical scenarios, allowing the operator to practise in a safe and controlled manner before actually operating on patients.

[0021] However, the Applicant has observed that the training apparatuses marketed to date present several problems.

[0022] In the first place, the training apparatuses marketed to date do not realistically and faithfully reproduce the actual interaction between the endovascular flow diverter device and the patient's blood vessels, thus not faithfully reproducing the haptic feedback, that is, the tactile sensation, that the endovascular surgeon / radiologist will experience during the actual intervention on the patient.

[0023] Furthermore, current training apparatuses have poor visual quality, limiting the monitoring of the surgical intervention during the simulation.

[0024] In addition to the above, the materials used to date in the training apparatuses have very high costs.

[0025] Furthermore, some of the training apparatuses used in the operating theatre and currently on the market force the operators to be exposed to high levels of ionising radiation during the simulation of the intervention, with the obvious drawbacks that this entails.

[0026] There is therefore a need to solve the above-mentioned problems.

[0027] The object of the present invention is to satisfy the above-mentioned need, preferably in an optimised and economical manner.

[0028] Summary of the Invention

[0029] According to the invention, the object is achieved by a training apparatus for an endovascular intervention as claimed in claim 1.

[0030] The dependent claims disclose particular embodiments of the invention.

[0031] Brief Description of the Drawings

[0032] For a better understanding of the present invention, a preferred embodiment is described hereinafter, by way of non-limiting example and with reference to the accompanying drawings, in which: - Figure 1 schematically illustrates a training apparatus in side view according to an embodiment of the present invention, with parts in section and parts removed for clarity; and

[0033] - Figure 2 is an enlarged view, of the apparatus illustrated in Figure 1, with parts in section and parts removed for clarity.

[0034] Detailed Description of the Invention

[0035] Figure 1 illustrates a training apparatus 1 for an endovascular intervention, which is adapted to be used by operators such as, for example, endovascular surgeons / radiologists, trainee doctors or students during learning and / or during preparation for an endovascular intervention on a patient, to practise the operations to be performed during the intervention.

[0036] The training apparatus 1 preferably comprises an outer casing 2 internally defining a simulation volume 3.

[0037] The simulation volume 3 is adapted to contain a first fluid Fi, in particular a liquid, having a refractive index ni.

[0038] In particular, the first fluid Fi at least partially occupies the simulation volume 3.

[0039] The training apparatus 1 further comprises a simulation block 5 (or master model) configured to physically replicate, preferably in three dimensions, an anatomical element.

[0040] According to one aspect of the present invention, in use, the simulation block 5 is preferably intended to be positioned inside the outer casing 2, in the simulation volume 3. In addition, the simulation block 5 is preferably intended to be at least partially immersed in the first fluid Fi. It is understood that, in other application examples, described in more detail hereinafter, the simulation block 5 may not be immersed in the first fluid Fi.

[0041] The simulation block 5 is preferably monolithic, that is, it is made in a single piece.

[0042] Preferably, the simulation block 5 has a tridimensional structure.

[0043] In addition, the simulation block 5 is traversed internally by at least one internal cavity 11 adapted to simulate / reproduce a blood vessel of said patient, that is, a section of the circulatory system of the same patient.

[0044] Preferably, the internal cavity 11 exactly represents / reproduces one or more arterial or venous vessels of the patient.

[0045] In other words, the internal cavity 11 preferably simulates a lumen of one or more vessels and is conveniently a through-passage, that is, it is provided with an inlet opening and at least one outlet opening adapted to place both ends of the internal cavity 11 in fluid communication with the outside, so as to be traversable by a fluid.

[0046] Preferably, the internal cavity 11 is shaped in such a way as to reproduce at least a section of the circulatory system of a patient. In addition, in use, the internal cavity 11 is adapted to be traversed by an endovascular device such as a catheter, a flow diverter, a guidewire, a stent-graft, a positioning balloon, a metallic coil and / or similar endovascular medical devices.

[0047] In other words, as will be explained in more detail hereinafter, during the simulation the internal cavity 11 is adapted to be traversed by an endovascular medical device inserted by an operator, such as for example an endovascular surgeon / radiologist, a trainee doctor or a student.

[0048] Preferably, as illustrated by way of example in Figures 1 or 2, the internal cavity 11 comprises at least one widening or dilation 12 of the vessel.

[0049] The dilation 12 can be configured to replicate a patient's aneurysm.

[0050] It is understood that the internal cavity 11 can be configured to reproduce blood vessels of a patient possibly affected by various pathologies, such as emboli and / or similar pathologies.

[0051] In other words, in application examples, the internal cavity may be devoid of the dilation 12.

[0052] In general, an aneurysm can commonly present a plurality of efferent vessels, for which reason, as illustrated in Figure 2 merely by way of example, the dilation 12 presents a plurality of efferent vessels.

[0053] According to the illustrated example, the internal cavity 11 preferably presents an afferent segment placed upstream of the dilation 12 and adapted to simulate the afferent vessel to the aneurysm.

[0054] In addition, the internal cavity 11 preferably presents one or more efferent segments placed downstream of the dilation 12 and adapted to simulate the efferent vessel or vessels from the aneurysm.

[0055] Preferably, the simulation block 5 has an approximately parallelepipedal shape, for example a rectangular parallelepiped.

[0056] It is understood that the present invention is not limited to a simulation block 5 of parallelepipedal shape, but could comprise simulation blocks of different shapes such as cylindrical, tetrahedral and / or similar.

[0057] Alternatively, the simulation block 5 could present a shape that reproduces an anatomical element, for example an organ of a patient such as the brain or other similar anatomical portion.

[0058] With reference to the example illustrated in figures 1 and 2 the simulation block 5 is preferably adapted to be at least partially immersed, and more advantageously entirely in the first fluid Fi temporarily contained in the outer casing 2. In use, the training apparatus 1 is adapted to make it possible for an operator to perfect the manual practice in the treatment of the aneurysm, and in particular in the functional positioning of the aforesaid endovascular medical devices at the aneurysm, that is, of the dilation 12.

[0059] According to a preferred embodiment, the simulation block 5 is adapted to be entirely immersed and covered by the fluid Fi temporarily present in the outer casing 2.

[0060] Preferably, the simulation block 5 is made of elastic polymeric material. For example, the simulation block 5 may be at least partially made of silicone.

[0061] In addition or alternatively, the simulation block 5 may be made of other elastic polymeric materials, such as for example solid polymer gel or other similar materials.

[0062] More in detail, the simulation block 5 is preferably made of polymeric material with a low elastic modulus. For example, the elastic modulus of the block of simulation may be between 0.1 MPa and 7 MPa.

[0063] The use of a simulation block 5 with an adequate elastic modulus makes it possible to emulate the biomechanical characteristics of the patient's organic tissues, and makes it possible, for example, to assess the seal of the inserted endovascular devices, for example by exerting a pressure on the outer surface of the block or by increasing the pressure inside the cavities. In addition, the simulation block 5, thanks to its monolithic structure and to its low elastic modulus, is reusable, and allows for multiple insertions and removals of the endovascular devices and / or of embolising liquids, by accessing the internal cavity or cavities 11.

[0064] In addition, the simulation block 5 is preferably made of transparent material. In particular, the simulation block 5 is preferably made of transparent silicone (high transparency).

[0065] More in detail, the material of the simulation block 5 has a refractive index m.

[0066] Preferably, the refractive index of the first fluid Fi corresponds to the refractive index m of the simulation block 5; if this condition is satisfied, the simulation block 5 becomes indistinguishable / imperceptible to the human eye once immersed in the first fluid Fi. More in detail, the first fluid Fi is preferably transparent, similarly to the simulation block 5.

[0067] This in particular makes it possible to avoid the edges of the simulation block 5 being visible / distinguishable and causing distortions or refractions of light that adversely affect the visualisation of the internal cavity 11.

[0068] According to a possible embodiment, the simulation block 5 is preferably made by means of three-dimensional moulding techniques or other additive manufacturing techniques.

[0069] Preferably, the simulation block 5 is made from a three-dimensional digital model which reproduces at least one anatomical portion of a patient. For example, such a three-dimensional digital model can be reproduced thanks to the processing of clinical images acquired through diagnostic techniques such as, for example, CT (Computed Axial Tomography), magnetic resonance, ultrasound and / or other similar clinical image acquisition techniques, and subsequently be suitably processed.

[0070] According to the embodiment described above, it is therefore possible to make the simulation block 5 on the basis of diagnostic data, for example diagnostic images, relating to a specific patient. In other words, it is possible to make for each patient a customised simulation block 5 on the basis of the patient's own diagnostic data.

[0071] In particular, the production method of the simulation block 5 described above makes it possible to reproduce with high precision the blood vessel of a patient affected by an aneurysm.

[0072] Preferably, the training apparatus 1 is configured in such a way that the operator can easily change the simulation block 5 to practise on different clinical cases.

[0073] For example, with the training apparatus 1, a plurality of different simulation blocks 5 can be provided, each representing a clinical case.

[0074] Preferably, the outer casing 2 has a substantially parallelepipedal shape, more preferably it comprises a bottom wall 21 and a plurality of side walls 22 advantageously connected together seamlessly. Conveniently, the outer casing 2 is open at the top.

[0075] Preferably, the outer casing 2 is made of a transparent material, such as glass, plexiglass or other similar polymeric material.

[0076] The training apparatus 1 further comprises a supply apparatus 6, which in use is hydraulically connected to the internal cavity 11 and is adapted to transport the first fluid F i inside the internal cavity 11.

[0077] Preferably, the first fluid Fi comprises an aqueous-based solution containing a lubricating liquid such as for example a vegetable oil derivative or other, it may for example be composed of water and vegetable glycerine in similar proportions.

[0078] Preferably, the use of the first fluid Fi containing a lubricant, preferably a vegetable oil derivative or similar, has the technical effect of reducing the coefficient of friction of the internal wall 20 of the internal cavity 11, in such a way as to make the interaction between the surfaces of the internal cavity 11 and the endovascular medical device as realistic as possible, so as to provide a haptic feedback as similar as possible to the actual haptic feedback that will be experienced on the patient during the endovascular treatment.

[0079] The possibility of injecting the first fluid F inside the internal cavity 11 also has the technical effect of being able to completely fill the internal cavity 11 with the first fluid Fi having the same refractive index as the surrounding simulation block 5, in such a way that, when it is filled with said first fluid Fi, the cavity 11 is also not distinguishable to the human eye, that is, both the simulation block 5 and the first fluid Fi are transparent, thereby simulating the effect of fluoroscopy.

[0080] In particular, the use of the first fluid Fi with a refractive index equal to that of the simulation block 5 and containing vegetable -based lubricants has two combined technical effects, namely rendering transparent and indistinguishable / imperceptible to the human eye the cavities 11 once filled, and lubricating the internal walls of the cavities 11 and improving the haptic perception during the navigation and insertion of the endovascular medical device.

[0081] According to one aspect of the present invention, the first fluid Fi preferably also comprises components or liquids or solutes which are surfactants. The technical effect related to the addition, in the first fluid Fi, of surfactant components is linked to the possibility of removing / eliminating any air bubbles present in the first fluid Fi, in such a way as to improve the quality of the images acquired by means of the image acquisition device described hereinafter.

[0082] Conveniently, the supply apparatus 6 is also configured to supply inside the internal cavity I l a second fluid F2, preferably separate and distinct from the first fluid Fi.

[0083] Preferably, the second fluid F2 may have the same composition as the fluid Fi but is optionally mixed with: a colourant, a radiopaque contrast liquid and / or other substances useful for the function.

[0084] In particular, the lubricating liquid contained in F2 also has lubricating properties, that is, it makes it possible to reduce the coefficient of friction of the internal wall 20 of the cavity 11, making realistic the insertion, positioning and / or physical interaction between the internal cavity 11 which simulates the lumen of the patient's blood vessel, and the endovascular device inserted into the internal cavity 11 by the operator.

[0085] More in detail, the second fluid F2 may also comprise an aqueous-based solution containing a lubricating liquid such as for example a vegetable oil derivative or other, it may for example be composed of water and vegetable glycerine in similar proportions. Optionally, and not necessarily, the second fluid F2 may also comprise components or liquids or solutes which are surfactants, in such a way as to remove / eliminate any air bubbles present in the same second fluid F2.

[0086] Preferably, the second fluid F2 may have a refractive index ns different from the refractive index of the fluid Fi and / or from the refractive index m of the simulation block 5, in such a way as to be visible to the human eye once injected inside the internal cavity 11.

[0087] In the case where the second fluid F2 includes a radiopaque contrast liquid, the vessels may appear visible even when subjected to fluoroscopy. According to a possible embodiment, the supply apparatus 6 may comprise pumping means 7 adapted to be hydraulically connected to the internal cavity 11 and configured to draw the first fluid Fi or the second fluid F2 from a source of said fluids Fi or F2 (for example a reservoir) and to supply a pressurised flow of the fluid Fi or F2 inside the internal cavity 11 of the simulation block 5.

[0088] For example, the pumping means 7 may comprise an electrically driven peristaltic pump.

[0089] In addition or alternatively, the pumping means 7 could comprise a volumetric pump, for example electrically driven.

[0090] In addition or alternatively, the pumping means 7 may comprise a syringe or other similar manually driven pumping means, such as for example an IV drip set.

[0091] With reference to the example illustrated in Figures 1 and 2, the supply apparatus 6 preferably also comprises a hydraulic connection circuit 4 adapted to hydraulically connect the delivery of the pumping means with the internal cavity 11.

[0092] In particular, the hydraulic connection circuit 4 preferably comprises at least one delivery duct 13 or afferent duct, which is adapted to hydraulically connect the delivery of the pumping means 7 with the inlet of the internal cavity 11, that is, with the afferent segment of the internal cavity 11 placed upstream of the dilation, in such a way as to make it possible to supply the fluid Fi or F2 inside the internal cavity 11.

[0093] In addition, the delivery duct 13 is preferably fluidically separated from the internal volume of the outer casing 2, in such a way as to keep fluidically separate the fluid Fi or F2 which circulates inside the delivery duct 13 from the first fluid Fi present inside the outer casing 2.

[0094] Preferably, the pumping means 7 and the source of said fluid Fi or F2 are located outside the outer casing 2.

[0095] In the example illustrated in Figures 1 and 2, the delivery duct 13 is at least partially housed inside the outer casing 2.

[0096] More in detail, the delivery duct 13 preferably traverses an inlet through-opening 24 of the outer casing 2, in particular disposed at a side wall 22 of the outer casing 2. Preferably, the delivery duct 13 sealingly engages the inlet through-opening 24, in such a way as to guarantee the hydraulic seal of the same outer casing 2 and to prevent the escape of the first fluid Fi contained therein.

[0097] Preferably, the delivery duct 13 may also be provided with inlet valve means 15 (schematically illustrated in the figures), which are fluidically interposed between the delivery of the pumping means 7 and the internal cavity 11, are advantageously positioned outside the outer casing 2, and are configured to control and regulate the flow rate of the fluid Fi or F2 supplied inside the internal cavity 11.

[0098] Preferably, the inlet valve means 15 are further configured to be traversable by a navigation device, for example a catheter, a stent, a stent-graft, a positioning balloon, and / or similar.

[0099] For example, the inlet valve means 15 could comprise a flow regulating valve, for example manually driven, configured to regulate a flow rate of the fluid Fi or F2 inside the delivery duct 13.

[0100] According to the embodiment illustrated in figure 2, the hydraulic connection circuit 4 preferably further comprises a hydraulic connector 16 configured to hydraulically connect the delivery duct 13 with the inlet of the internal cavity 11 of the simulation block 5.

[0101] Preferably, the hydraulic connection circuit 4 further comprises at least one discharge duct 17 or efferent duct configured to hydraulically connect a respective outlet of the internal cavity

[0102] 11, that is, a respective efferent segment of the internal cavity 11, with the external environment, in such a way as to allow the outflow of the fluid Fi or F2 after the latter has traversed the internal cavity 11.

[0103] As mentioned above, an aneurysm can present one or more efferent vessels. According to the exemplary embodiment illustrated, the internal cavity 11 of the simulation block 5 presents a plurality of efferent segments (three in the example illustrated) which branch off from the dilation

[0104] 12, each adapted to simulate a respective efferent vessel from the aneurysm.

[0105] It is understood that the internal cavity 11 of the simulation block 5 could also present only one efferent segment downstream of the dilation 12.

[0106] Preferably, the hydraulic connection circuit 4 further comprises at least one efferent discharge duct 17 of the internal cavity 11.

[0107] More in detail, with reference to the illustrated example, the hydraulic connection circuit 4 may comprise a plurality of discharge ducts 17. For example, the hydraulic connection circuit 4 may comprise a discharge duct 17 for each efferent segment of the internal cavity 11.

[0108] Preferably, the / each discharge duct 17 is configured to hydraulically connect the respective outlet of the internal cavity 11 with a discharge reservoir 30.

[0109] In addition, the / each discharge duct 17 is also fluidically separated from the internal volume of the outer casing 2, in such a way as to keep fluidically separate the second fluid Fi or F2 which flows out of the cavity 11 from the first fluid Fi present inside the outer casing 2.

[0110] In the example illustrated in Figures 1 and 2, the discharge duct 17 is at least partially housed inside the outer casing 2. Preferably, the / each discharge duct 17 traverses an outlet through -opening 26 made on the outer casing 2, for example at a side wall 22 thereof.

[0111] Preferably, the / each discharge duct 17 sealingly engages the outlet through-opening 26, in such a way as to guarantee the hydraulic seal of the same outer casing 2 and to prevent the escape of the first fluid Fi contained therein.

[0112] Preferably, the / each discharge duct 17 is also provided with outlet valve means 18, which are fluidically interposed between the respective outlet of the discharge duct 17 and the external environment, are advantageously positioned outside the outer casing 2, and are configured to control the outflow of the fluid Fi or F2 exiting the internal cavity 11, in particular towards the discharge reservoir 30.

[0113] More in detail, a plurality of outlet valve means 18 may be provided, for example one for each discharge duct 17 and / or for each efferent segment of the internal cavity 11.

[0114] Preferably, the outlet valve means 18 are further configured in such a way as to be traversable by said endovascular device.

[0115] According to the embodiment illustrated in figure 2, the hydraulic connection circuit 4 preferably further comprises one or more second hydraulic connectors 19 configured to hydraulically connect a respective outlet of the internal cavity 11 of the simulation block 5 with the respective discharge duct 17.

[0116] Advantageously, the simulation block 5 can be rapidly replaced with a new simulation block 5 of a different clinical case by decoupling the hydraulic connector 16 and the second hydraulic connector 19, in such a way as to separate the hydraulic connection circuit 4 from the simulation block 5.

[0117] According to one aspect of the present invention, the hydraulic connection circuit 4, in particular the discharge ducts 17, may also comprise sensor means adapted to measure the flow rate of the fluid flowing along the same hydraulic connection circuit and / or inside the cavity or cavities 11.

[0118] For example, said sensor means may be located along at least one discharge duct 17. In the case of aneurysms, for example, this makes it possible to detect the flow rate of fluid downstream of the dilation 12, making it possible, for example, to detect any obstructions caused by the previously inserted medical device.

[0119] With reference to the example illustrated in figure 1, the training apparatus 1 preferably comprises a light radiation source 8, which is adapted to be disposed adjacent to, and more advantageously in contact with, the outer casing 2 and / or the simulation block 5, in such a way as to emit light radiation in the direction of the simulation volume 3 and / or of the simulation block 5, and to illuminate the simulation block 5 possibly temporarily housed therein.

[0120] Preferably, the light radiation source 8 is positioned beneath the outer casing 2, that is, beneath the bottom wall 21.

[0121] In addition, the training apparatus 1 comprises an electronic control unit, which is electrically connected to the light radiation source 8 and is adapted to control the operation of the latter.

[0122] In particular, the light source 8 comprises a bidimensional diffuse light source, such as lightboard or overhead projector. For example, the overhead projector comprises preferably a plurality of light-emitting diodes (LEDs) or other similar light source.

[0123] Preferably, the overhead projector is configured to illuminate the simulation block 5 diffusely, that is, to simultaneously illuminate the entire simulation block 5. This makes it possible to acquire images of the same simulation block 5 analogous to images traditionally acquired by means of fluoroscopy. In addition, the use of a overhead projector makes it possible to visualise entirely the cavities 11 and / or the dilation 12 even in the case of complex three- dimensional geometries.

[0124] The use of point-like, filiform, and / or other similar collimated light sources, such as a laser blade, make it possible to illuminate only a portion or section of the simulation block 5, and consequently does not make it possible to visualise entirely the cavities 11 and / or the dilation 12 also in the case of complex three-dimensional geometries.

[0125] The training apparatus 1 further comprises at least one image acquisition device 9 configured to acquire images of at least one of the outer casing 2, the simulation block 5 and the simulation volume 3.

[0126] Preferably, the image acquisition device 9 is further configured to store the acquired images.

[0127] Advantageously, by using two or more image acquisition devices 9, for example two or more video cameras, it is possible to acquire two or more independent planes of the simulation block 5 with the related endovascular devices released during training and to locate them in three- dimensional space by means of stereoscopic reconstruction techniques.

[0128] The electronic unit is preferably also operatively connected to the image acquisition device 9, in such a way as to be able to control its operation.

[0129] In addition, the training apparatus 1 preferably comprises support means 28 configured to support the image acquisition device 9 and to position it facing at least one of the outer casing 2, the simulation block 5 and the simulation volume 3, on the opposite side to the light radiation source 8.

[0130] More in detail, the training apparatus 1 could comprise a plurality of support means 28, each configured to support a respective image acquisition device 9.

[0131] For example, the support means 28 could comprise a robotic support arm, an adjustable support bracket and / or other similar support means.

[0132] For example, the support means 28 may comprise a joint with a plurality of degrees of freedom adapted to support the image acquisition device or devices 9.

[0133] Thanks to the support means 28, it is possible to position the image acquisition device or devices 9 in different positions or at different angles with respect to the outer casing 2, in such a way as to be able to acquire images of the simulation block 5 from different angles / observation points.

[0134] This has the technical effect of making it possible to optimise the position and / or orientation of the image acquisition device 9 with respect to the shape or position of the cavity 11 and of the dilation 12, if present. In particular, the support means 28 make it possible to visualise the simulation block 5 by means of the image acquisition device 9 from a plurality of different angles, in such a way as to be able to improve the visualisation of the dilation 12 and / or of the cavities 11, also in the case of complex three-dimensional geometries.

[0135] In addition, the support means 28 make it possible to simulate the iso-centric movement of some known fluoroscopy systems, such as mobile radiological systems, C-shaped, traditionally known as C-Arm.

[0136] Preferably, the / each image acquisition device 9 comprises a digital video camera.

[0137] Alternatively, the / each image acquisition device 9 could comprise a mobile phone provided with an internal or external video camera or other similar image acquisition device.

[0138] The training apparatus 1 further comprises at least one image display and / or recording device 10 configured to display the images and / or videos acquired and / or stored by the / each image acquisition device 9.

[0139] Preferably, the / each image display device 10 comprises a computer, a tablet, a television or other similar digital image display apparatus.

[0140] The images acquired by the / each image acquisition device 9 are preferably displayed by means of a screen / monitor of said image display device 10.

[0141] For example, the images acquired by the / each image acquisition device 9 may be displayed on the screen in greyscale. Alternatively, the / each image display device 10 is a monitor configured to display the images and / or videos acquired by the / each image acquisition device 9.

[0142] The image display device 10 is preferably operatively connected to the electronic unit.

[0143] Preferably, the / each image acquisition device 9 is configured to acquire images of at least one of the elements comprised between the outer casing 2, the simulation block 5 and the simulation volume 3 and to transmit, preferably in real time, said images to the / each image display and recording device 10.

[0144] For example, the / each image acquisition device 9 can be connected to the / each image display and recording device 10 by means of a wireless connection or by means of a wired connection, for example by means of a High-Definition Multimedia Interface (HDMI), USB cable or similar. The display of the data acquired by means of images / videos can take place in real time or can be postponed using the images / videos stored by the / each image acquisition device 9.

[0145] According to one aspect of the present invention, the electronic control unit is also configured to control the image acquisition device 9 and the image display and recording device 10 in such a way as to implement a Roadmap function.

[0146] In other words, the electronic control unit is configured to create, on the basis of the data acquired by the image acquisition device 9, a digital map in which are displayed, preferably in real time, the endovascular devices inserted inside the cavities 11, optionally masking portions of the acquired images outside the cavities 11. The electronic control unit is also configured to control the image display and recording device 10 in such a way as to display said digital map.

[0147] More in detail, the aforesaid Roadmap function provides for the following operations, implemented at least in part by means of the electronic control unit:

[0148] 1) Injecting a first contrast liquid, for example dark, into the internal cavity 11,

[0149] 2) Acquiring an image of the simulation block 5 with the first contrast liquid in the internal cavity 11 (in this way, the material of the simulation block 5 appears light while the internal cavities appear dark),

[0150] 3) Processing a mask of the internal cavities by inverting the image acquired at point 2, in such a way as to obtain a map, preferably light on a dark background, of the internal cavities 11,

[0151] 4) Displaying, advantageously in real time, the movement and / or position of the endovascular devices by overlaying them on the previously processed mask of the internal cavities 11. In use, this functionality makes it possible to map the anatomy of the cavities 11 starting from the frames acquired in the presence of the contrast liquid, generating a reference image on which it is then possible to monitor in real time only the lumen of the same cavities 11.

[0152] In use, this functionality has the beneficial effect of reducing ionising radiation and limiting the use of contrast liquid during the endovascular procedure, since a single initial injection of contrast liquid is sufficient to map the morphology of the internal cavities 11.

[0153] The operation of the training apparatus 1 described above is as follows.

[0154] In a first step, the simulation block 5 is connected to the delivery duct 13 and the discharge ducts 17 by means of the hydraulic connectors 16 and 19 interfacing with the simulation block 5.

[0155] In addition, the simulation block 5 is preferably placed on the bottom of the outer casing 2 and positioned in the most convenient way to promote the functionality of the process.

[0156] Subsequently, the simulation volume 3 may be filled with the first fluid Fi; consequently, the simulation block 5, the material of which has the same refractive index as the first fluid Fi, is immersed and covered by the same fluid Fi in such a way that the simulation block 5 becomes indistinguishable / invisible to the human eye as previously detailed.

[0157] According to a possible embodiment, before the supply of the first fluid Fi, an aqueous solution temporarily containing surfactants may be supplied inside the cavities 11, for the purpose of eliminating air bubbles possibly present initially inside the cavities. In use, said aqueous solution containing surfactants is then removed from the cavities 11 during the subsequent supply of the first fluid Fi.

[0158] At this point, the light source 8 is activated, in such a way as to illuminate the simulation block 5, and the image acquisition device or devices 9 and the image display and recording device or devices 10 are activated.

[0159] Subsequently, the first fluid Fi is supplied by means of the supply apparatus 6. In particular, the first fluid Fi supplied into the delivery duct 13 reaches and penetrates inside the internal cavity 11 of the simulation block 5, filling the same internal cavity 11.

[0160] Consequently, the internal cavity 11 is rendered indistinguishable / invisible to the human eye, as the first fluid Fi has the same refractive index as the simulation block 5.

[0161] Subsequently, the supply apparatus 6 is operated in such a way as to supply the second fluid F2 inside the delivery duct 13 and the internal cavity 11 of the simulation block 5. Consequently, the second fluid F2 causes the expulsion from the internal cavity 11 of the first fluid Fi previously supplied, completely filling the internal cavity 11 itself.

[0162] In this way, the internal cavity 11 becomes distinguishable to the human eye and in particular becomes visible to the human eye, and can be perceived by means of the image acquisition device or devices 9 and the image display device or devices 10, thus simulating the visual effect of the contrast obtained during a fluoroscopy.

[0163] This has the technical advantage of not exposing the operator to ionising radiation which is hazardous to health, as no radiation is used to visualise the internal cavity 11.

[0164] In a particular form of use, the second fluid F2 may contain a radiopaque contrast liquid which makes the blood vessels visible also by means of fluoroscopy.

[0165] In particular, the delivery duct 13 simulates an afferent vessel of the simulation block 5, and therefore of the simulated anatomical element in which the aneurysm is present, while the discharge duct 17 simulates an efferent vessel of the simulation block 5, and therefore of the simulated anatomical element.

[0166] Therefore, the operator can begin the simulation of the endovascular surgical intervention. In particular, the operator proceeds with the insertion, through the inlet valve means 15 and the access opening 24, of an endovascular device, and then traverses the inlet duct 13, which is inside the simulation volume 3, until reaching the dilation 12 which represents the aneurysm; then, he or she seeks the correct positioning of the device and finally performs the endovascular treatment.

[0167] During the performance of the simulation, the image acquisition device or devices 9 acquire(s) images of at least one of the elements comprised between the outer casing 2, the simulation block 5 and the simulation volume 3, and transmit(s) said images to the image display and recording device or devices 10 advantageously in real time, in such a way that the operator can directly control on the monitor the movement and positioning of the endovascular device inside the simulation volume 3 and can subsequently review the entire process, in addition to being able to enjoy the direct vision of the simulator.

[0168] The process thus developed places the operator in a condition to simulate the same operating procedures of an endovascular intervention, wherein viewing can take place exclusively through the fluoroscopy monitor and not also by direct viewing of the simulator.

[0169] The training apparatus 1 is configured in such a way that the operator can repeat all the previously detailed operations on different clinical cases, simply by replacing the simulation block 5.

[0170] From the foregoing, the advantages of the training apparatus 1 according to the present invention are clear.

[0171] In the first place, the training apparatus 1 makes it possible to realistically reproduce the use of fluoroscopy during an endovascular surgery intervention without generating radiation which is harmful to the operator. Furthermore, the injection of the fluid Fi or F2 containing a lubricating liquid inside the internal cavity 11 makes it possible, during the simulation activity, to provide the operator with a haptic feedback between the endovascular device used and the wall 20 of the internal cavity 11 which faithfully reproduces the actual physical interaction between the same endovascular device and the walls of the patient's blood vessels, with the evident advantages that this entails.

[0172] Moreover, the injection of the second fluid F2 containing a colourant or a radiopaque contrast liquid inside the internal cavity 11 makes it possible to optimise the visibility during the simulation of the intervention.

[0173] In addition, the image acquisition device or devices 9 make(s) it possible to acquire images of the simulation block 5 from different angles and positions, improving the visibility and monitoring of the simulation, similarly to the operation of a fluoroscope used in operating theatres. The video recording enables medical personnel to critically review the process and to perform comparative analyses on the same simulation block 5 between different operators.

[0174] In addition to the above, the simulation block 5 can be made from the three-dimensional digital model of an anatomical portion of a patient who is to undergo an endovascular surgical intervention, in such a way as to allow the operator to practise for the intervention to be performed on the patient under conditions equal to the real ones.

[0175] In fact, by means of three-dimensional moulding techniques, it is possible to reproduce a patient-specific simulation block 5 based on their diagnostic images, in such a way that the operator can train and improve their manual skills in the treatment of complex clinical cases.

[0176] In addition, the semi-rigid material of the simulation block 5 makes it possible to simulate vascular stenoses by locally applying pressure on the same simulation block 5 to locally obstruct at least partially the internal cavity 11.

[0177] Finally, the training apparatus 1 is compact, portable, usable outside the operating theatre, and of a much lower cost compared to the training apparatuses 1 currently available on the market, which makes it particularly advantageous to be used also in educational applications.

[0178] Finally, it is clear that modifications and variations may be made to the training apparatus 1 according to the present invention, without however departing from the scope of protection defined by the claims.

[0179] According to a not illustrated variant, the outer casing 2 may not be present. In such a case, the simulation block 5 would not be immersed in the first fluid Fl and would be disposed above the light radiation source 8, for example resting on top thereof. According to said variant, furthermore, the supply apparatus 6 is preferably connected directly to the inlet port or ports of the internal cavity 11 of the simulation block 5 by means of the hydraulic connection circuit 4.

[0180] Similarly, the outlet port or ports of the internal cavity 11 of the simulation block 5 are preferably connected directly to the discharge reservoir 30 by means of the hydraulic connection circuit 4.

[0181] An application example of said variant is a simulation block 5 of a middle meningeal artery useful, for example, for simulating embolization interventions. In such a case, the simulation block may have a thin structure or a plate-like shape, that is, to have a height smaller than its plan dimensions.

Claims

CLAIMS1.- Training apparatus (1) for an endovascular intervention on a patient, said training apparatus (1) comprising: a simulation block (5), which is made of a material having a first refractive index (m) and comprises at least one internal cavity (11) configured to simulate a blood vessel of said patient, a supply apparatus (6), which is adapted to be fluidically connected to said internal cavity (11) and is adapted to supply at least one of a first fluid (Fi) having a second refractive index (ni) and a second fluid (F2) inside said internal cavity (11), said second fluid (F2) being separate and distinct from said first fluid (Fi) and having a third refractive index (ns) different from said first refractive index (m) and from said second refractive index (m), a light radiation source (8), which is adapted to be disposed facing said simulation block (5) in such a way as to emit light radiation towards the same simulation block (5), image acquisition means (9) configured to acquire images of at least the simulation block (5); and image display and recording means (10) configured to display the images acquired by the image acquisition means (9).2.- Training apparatus according to claim 1, wherein the first refractive index (m) of the material of the simulation block (5) corresponds to the second refractive index ( ) of the first fluid (Fi).3.- Training apparatus according to claim 1 or 2, wherein the image acquisition means (9) are configured to store and / or transmit in real time the acquired images to the image display means (10).

4. Training apparatus according to any one of claims 1, 2 or 3, further comprising a hydraulic connection circuit (4) configured to hydraulically connect the supply apparatus (6) with said internal cavity (11).5.- Training apparatus according to any one of claims 1 to 4, wherein said simulation block (5) is made by means of three-dimensional additive printing techniques.6.- Training apparatus according to claim 5, wherein said simulation block (5) is made on the basis of a three-dimensional digital model of the arterial or venous malformations of a patient's blood vessel obtained by means of diagnostic image acquisition techniques.7.- Training apparatus according to any one of the preceding claims, wherein the material of said simulation block (5) comprises silicone.8.- Training apparatus according to any one of the preceding claims, wherein said first fluid (Fi) and / or said second fluid (F2) comprise a solution containing a lubricating liquid.

9. Training apparatus according to claim 8, wherein the lubricating liquid comprises water and a vegetable oil derivative.

10. Training apparatus according to claim 8 or 9, wherein said second fluid (F2) comprises a solution containing the lubricating liquid mixed with a radiopaque contrast liquid or colourant or other substance.11.- Training apparatus according to any one of the preceding claims, wherein the outer casing (2) is transparent. 12.- Training apparatus according to any one of the preceding claims, wherein said light source (8) comprises a overhead projector.13.- Training apparatus according to any one of the preceding claims, comprising support means (28) configured to support said image acquisition device (9) and position it facing said simulation block (5), on the opposite side to said light radiation source (8) at a variable angle.

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