IT202000026161A1 - SYSTEM FOR THE RADIANT TREATMENT OF TUMORS AND RELATED METHOD OF USE. - Google Patents

Description

SYSTEM FOR THE RADIANT TREATMENT OF TUMORS E

RELATED METHOD OF USE

The present invention generally refers to a system for the radiation treatment of tumors and to the relative method of use.

Among the diseases feared of our times? there is no doubt that the tumor is to be considered prominent due to the mortality rate? presented by some types and the difficulty? of care.

With the terms ?cancer? and ?tumor?, refers to a pathological condition that develops when cells begin to grow and proliferate in an uncontrolled way in a part of the body, infiltrating normal organs and tissues, altering their structure and functioning.

In particular, cancer ? caused by DNA mutations within cells; cellular DNA contains information about how cells should grow and multiply, and mistakes in these instructions cause the cell to become cancerous.

Does this random genetic disorder explain the extreme variability? for appearance, effects, symptoms and prognosis of the many forms of cancer still known.

Furthermore, cancer also has the ability to to locate at a distance from the primary disease generating, in this case, a secondary or metastatic disease. Tumors are divided into solid tumors, characterized by a compact mass of tissue, and blood tumors.

? It is also possible to classify tumors in various different ways, depending on the organ in which they develop, the type of cells that are formed, the stage at which the disease is at diagnosis, the aggressiveness of the tumors. and the possibility of development of metastases.

Tumors, although the general mechanism of origin is unique, can show a very wide range of evolutions and symptoms. In all for? ? constant an increase in the number of cancer cells, due to the higher speed? cell reproduction, whereby more cancer cells multiply and fewer die, while those that survive continue to multiply.

Usually the growth of a tumor follows a geometric law: ? very slow at first, but accelerates as tumor mass increases. The critical size of a tumor ? about a cubic centimeter; once this size is reached, the tumor begins to grow very quickly and give rise to the first symptoms and becomes detectable with medical examinations and tests.

Often for? the initial symptoms are ignored or underestimated.

One of the most used methods to treat the majority of solid and isolated tumors? the surgical operation. Isn't this methodology? always usable or, when used, not ? always sufficient to ensure the desired result; Moreover ? is it possible that the?surgical operation in itself? lead to the dissemination of tumor cells.

For these reasons, chemotherapy and radiotherapy are also used in combination or as an alternative to surgery.

Chemotherapy exploits the sensitivity? specific of individual tumors to certain substances, and, for each patient, a personalized mixture of more? drugs. Almost always in this mixture there are one or more? mitosis inhibitors to hinder cell proliferation. Are for? these drugs are responsible for some side effects, such as, for example, the hair loss that afflicts patients undergoing chemotherapy.

Radiotherapy? a treatment that involves the use and irradiation, through ionizing radiations, usually X-rays, of the neoplastic and/or neighboring tissues of the neoplasia, trying to spare the healthy tissues.

Radiation therapy also has side effects. In fact, like chemotherapy, it considerably weakens the body and subjects the patient's healthy organs to its direct effects, even if only partially.

In both cases, therefore, ? it is important to be able to minimize their application in order not to make the side effects become too significant.

The case of oral cavity cancer is now described, only by way of example.

The cancer of the oral cavity, that is? of the mouth, can? originate, for example, from the tongue, lips, especially the lower part, the back of the throat, tonsils, salivary glands, gums, palate, inner cheeks and under the tongue.

The formation on the surface of the mouth of a swelling that does not go away over time, a white or reddish spot that does not heal or a wound that does not heal, are alarm signals because they could be the result of mouth cancer or a condition that preceded it.

In Italy, about 4,500 cases of oral cancer are diagnosed every year and about 3,000 deaths due to this disease are recorded. The number of new cases increases with age: ? very rare in young people and reaches a peak after the age of 70. The age? average at the diagnosis of oral cancer ? of 64 years and 95% of these arise after the age of 40.

The largest number of new cases is found above all in the Alpine areas and in the North-East, representing 4% of malignant tumors in men and 1% in women. Mouth cancer? more widespread in people who smoke tobacco and consume alcohol and the simultaneous presence of these two habits consequently multiplies the risk of developing it.

In recent years yes? observed a decline in new cases of alcohol- and tobacco-related mouth cancer in men, while in women recorded an increase.

The language turns out to be the seat pi? frequently affected; lingual malignant tumors, in fact, account for 30% of all malignant tumors of the mouth.

Furthermore, the tumor of the lip ? more frequent in men and develops, above all, in light-skinned people who spend a lot of time in the sun and in pipe smokers. Lip cancers account for about 11% of new cases, but are responsible for only 1% of total deaths. The median survival 5 years after diagnosis? by 50% (80-90% in cases with tumors limited to the site of appearance and 19% in patients with diffuse tumors).

Mouth cancer? the consequence of a series of modifications of the deoxyribonucleic acid (DNA) of the cells that constitute it; the latter, after these mutations, begin to multiply out of control, thus creating? a mass. Factors that increase the risk of developing mouth cancer include alcohol abuse, tobacco use, poor oral hygiene, Human Papilloma Virus infections, and the presence of broken or chipped teeth or dentures.

Currently, based on the data available, it is not It is possible to make recommendations for or against routine oral cancer screening, particularly for individuals who do not have symptoms. ? in any case, it is recommended to have a dental visit a year, to check the health of the teeth and mucous membranes. This practice becomes essential after the age of 60 in subjects who have had a lifestyle that is considered to be at risk.

As with most tumours, healing of oral cavity cancer depends on general health conditions, location and spread to regional lymph nodes or other parts of the body, although, to date, at the time of diagnosis, beyond the met? of tumors of the oral cavity appears to be already? spread to sites proximal to the tumor. Overall, the median survival five years after diagnosis? of 50%, while it oscillates between 80 and 90% in patients with tumors confined to the site of onset and ? 19% in patients with metastatic tumors. Once a suspicious growth/ulceration of the cavity has been identified, by, for example, the dentist or general practitioner, the surgeon must confirm the diagnosis through a biopsy and subsequent histological examination.

Dysplasia? an alteration of the normal structure of the mucosa and pu? be mild, medium and severe. all the more ? altered the mucosal structure, the greater the possibilities? that it turns into a cancer and for this reason ? It is important to recognize that single sores, red spots, or white spots (particularly if they persist longer than three weeks) can be manifestations of malignancy.

The biopsy of the tumor of the mouth, of that of the tongue and also of the jaw tumor is performed, when possible, under local anesthesia by taking one or more? tissue fragments of the suspicious area bordering the healthy mucosa. The biopsy must be large enough to include both a sufficient amount of suspicious tissue and some normal-appearing tissue at the same time. The fragment taken is then sent to be analyzed in a pathological anatomy laboratory.

Subsequently, ? fundamental to frame the performance status, the cio? the general conditions of the patient, through blood chemistry tests and the? operability? of mouth cancer depends on the local extension and the presence of locoregional or distant metastases. The exams that can be performed are the following:

- CT and MRI with and without contrast agent of the primary site including the entire head and neck area; at the request of the radiologist, in concert with the other doctors of the team, preparatory tests can also be performed for those indicated, such as Orthopantomography (OPTG) and the two orthogonal projections (AP/LL) of the skull performed remotely on a craniostat;

- PET with 18-fluorodeoxyglucose to identify the possible presence of metastases;

- CT of the chest, indicated why? the lungs are the site pi? common metastasis;

- Abdominal ultrasound to rule out possible liver involvement.

At the end of all these exams yes? able to define the nature, grading and staging of cancer of the mouth and, in particular, of cancer of the tongue.

Staging defines the size of the tumor in the mouth (T expressed in cm), the involvement of the laterocervical lymph nodes (N expressed in cm, number and omo/bilateral) and the presence of distant metastases (M positive or negative). Based on these parameters, a stage ranging from zero to fourth (IV) with various sublevels is assigned to the neoplasm.

The life expectancy of the patient depends on the stage, which, in turn, is derived from the aforementioned TNM classification.

The increasing size of the mouth tumor corresponds to an increase in stage, however the positivity? of N and of M are the prognostic factors pi? important able to shift the stage to the fourth (IV) (types a, b, c) regardless of the size of T.

The treatment of cancer of the mouth, cancer of the tongue and cancer of the jaw? multidisciplinary, of which the surgeon, the oncologist, the radiotherapist, the pathologist and the radiologist are the most? important.

The goal of the surgery? is to remove the primary tumor together with a margin of clinically healthy tissue (approximately 1 cm) to ensure complete removal of the malignant tissue. At the demolition stage it will have to? be associated, contextually, with the reconstructive one. The tracheotomy? a fundamental phase of the surgical treatment, if it is indicated. The lymph nodes of the neck constitute the first and main route of dissemination of neoplasms of the oral cavity and during the planning of the surgical act, the latter must be taken into consideration. In particular, the removal of laterocervical lymph nodes (emptying), in a tumor of the mouth or in a tumor of the tongue, can be done for prophylactic purposes (if the dimensions of the tumor, less than 2 cm, are such as to suggest a microscopic involvement of the lymph nodes), or for therapeutic purposes (if there are clinical or radiographic signs of lymph node involvement). There are three types of lateral neck dissection: radical necking, functional necking and selective necking. These differ in the sacrifice or preservation of laterocervical noble structures (the internal jugular vein, the sternocleidomastoid muscle and the accessory nerve) and in the different lymph node stations involved.

As previously mentioned, one of the therapies that can be used, even in the case of tumors of the oral cavity, in a complementary way to the surgical act, is just radiotherapy. In detail, radiotherapy can be used alone for the treatment of some forms of tumors (oropharyngeal) or in cases where surgery is contraindicated (poor health, extension of the disease) and can? be performed both on the tumor and on the neck; on both sites it has the function of ?sterilize? the surgical field according to the histological result (positive resection margins, involvement of one or more lymph node stations).

Globally, local healing of cavity carcinomas oral can be obtained today with a rather high frequency (60-65%). Obviously the percentages vary according to the location and extent of the disease, from 95% for small carcinomas of the lip to 30% for extensive tumors of the tongue and retromolar trigone. Loco-regional healing varies according to the presence or absence of lymph node metastases and their extension.

In particular, conventional high-energy radiotherapy techniques are currently conducted with a CLINAC (CLINICAL LINEAR ACCELERATOR) equipment, which delivers X-ray photons, generally up to 20 MeV, and electron beams of 15 MeV max. The operating principle is based on the linear acceleration of a beam of electrons produced by a MAGNETRON (or KLYSTRON), which collide against a gold plate (target) or other heavy metal (as pure as possible), thus producing, for bremsstrahlung, X-rays of high energy spectrum pi? possible restricted. Before it reaches the target volume, the beam is cos? say ?modified? with so-called warhead devices. Furthermore, the car isocentric, that is? the gantry (rotating arm) can? precisely rotate around a geometric point, identified in the centering and CT simulation phase, to which the Target Volume (or Tumor Volume) is referred.

Then taking advantage of the property? physics of the divergence of the beam of photons X, through the devices of warhead sar? it is possible to include in the useful bundle also the possible Complementary Volume, understood as that volume of tissue contiguous to the tumor and directly affected by it; in the Complementary Volume, any lymph nodes possibly involved, responsible for distant metastases, can also be included. Does the latest generation of medical equipment for clinical analyzes and treatments require control systems and motors of high precision and low noise? with ever greater power and dynamism? in more and more spaces reduced.

By way of example, multilayer radiological collimators are equipped with a system of individually motorized blades, whose position, intercepting the radiation beam to a greater or lesser extent, makes it possible to control and determine both its intensity and intensity. that shape it. There? ? particularly important in the treatment of malignant tumors, as it allows you to strike with the right intensity? of radiation only the tumor area, delimiting perfectly the contours and thus minimizing? the involvement of neighboring tissues. To move the numerous slats, very small linear micromotors equipped with transducers and individually controlled are required.

The shape of the irradiation field obtained on the image of the CT simulator is typed into the computer, which, being equipped with a special program, automatically proposes the most? appropriate distribution of the slats around the contour of each treatment field. The proposed lamellar distribution, if deemed adequate, is ?transferred? to the console of the linear accelerator: the motors of the individual slats of the collimator will be able to cos? create the irregular shape for single radiation therapy field.

Furthermore, the multi-lamellar collimators used nowadays, while avoiding the long preparation times of traditional shields and that of incorrect positioning of the shield, have a high purchase and maintenance cost. Another disadvantage related to this type of collimators? linked to dosimetric problems of dose transmission through the lamellae (e.g. penumbra of the beam); moreover, this type of technology ? difficult to use for some treatment techniques.

Another technique that is used today? radiotherapy with intensity beams? modulated (IMRT), which involves the use of multilamellar collimators. In particular, during the treatment the blades of the collimator move over the area to be irradiated with a sequence established and controlled by a computer, while the machine delivers the radiation beam. In this way ? It is possible to conform the fluence of the radiation beam to the area to be irradiated with greater precision than with conformal type radiotherapy.

Nowadays, generally, the radiotherapy techniques used are based on the emission of high-energy X photons (as previously mentioned), which are produced by the linear accelerators for clinical purposes CLINAC and by the same electrons up to 15 MeV and used for the control localization of tumors on surgical scars in the post-operative period.

There is also oncological hadrontherapy which mainly uses energy beams of protons but also of light ions (such as, for example, lithium, carbon, etc.) effective in the treatment of tumors that are poorly responsive to protons, such as sarcomas and lymphomas. Conversely, therapy with thermal neutrons, which have no charge, is not easy, as it involves the use of boron and there? involves the use of clinical practices prior to treatment.

The family of hadrons ? divided into three subgroups, according to the quark and antiquark composition and, in detail, ? divided into baryons, which are made up of three quarks, like protons and neutrons, and mesons, made up of a quark/antiquark pair, like pions and kaons. Even more particles? complex (such as light ions) are called hadrons.

Therefore, to date, there are no radiotherapy machines that are able to have successful radiobiological effects in the radiation therapy of deep-seated tumors.

The general purpose of the present invention is, therefore, that of overcoming the drawbacks of the known art described above and, in particular, that of realizing a system for the radiation treatment of tumors and relative method of use, which allows to selectively treat a deep neoplasm from different points in space, calculable with precise mathematical algorithms.

Another purpose of the present invention? that of realizing a system for the radiation treatment of tumors and relative method, which is extremely precise (in this way, it can be applied effectively, for example, to tumors of the oral line, such as oropharyngiomas, odontomas, etc.

Another purpose of the present invention ? relating to the creation of a system for the radiation treatment of tumors, the elements of which are resistant to the efforts made, without undergoing mechanical deformations, nor? thermal shocks such as to determine linear, superficial and/or volumetric variations in the system itself.

Another object of the present invention ? that of realizing a system for the radiation treatment of tumors and relative method of use, in which the movement of the relative mechanical parts is without friction and, therefore, without consequent thermal gradients, thus ensuring a higher quality? and the same repeatability? of the treatments, without instantaneous mechanical errors n? stochastic (that is, repeated over time).

Another purpose of the present invention? the creation of a system for the radiation treatment of tumors and relative method of use, which can be used both in the post-operative period and as a single treatment when the general conditions advise against surgery.

Not the ultimate goal? the creation of a system for the radiation treatment of tumors and relative method of use, which is particularly suitable for the oropharyngeal and dental district, since it is little invasive.

These and other objects are achieved by a system for the radiation treatment of tumors, according to the attached claim 1 and by means of a relative method of use, according to claim 13.

Further technical characteristics of the system for the radiation treatment of tumors of the invention are set forth in the further dependent claims. Other structural and functional characteristics of the present invention and the relative advantages with respect to the known art will be even more? clear and evident from an examination of the following description, referring to an exemplifying and preferred but non-limiting embodiment of the system for the radiation treatment of tumors and relative method, object of the present invention, and from the attached drawings, in which:

figure 1 shows a schematic view of the isocentric device for the radiation treatment of tumors, belonging to the system for the radiation treatment, according to a first embodiment of the present invention;

- figures 2A and 2B show a perspective view of a detail of the isocentric device of figure 1, in two different phases of use;

- figure 3 shows a graph relative to the Bragg peak relative to the energy loss that ionizing radiations have when they pass through matter; - figure 4A shows a perspective view of the unit? robotized isocentric simulation device, belonging to the system for the radiation treatment of tumors, object of the present invention;

- figure 4B shows a perspective and schematic view of the unit? of simulated isocentric simulation, object of the present invention, in which the movement of the relative joints is highlighted;

- figure 5 schematically shows the unit? lateral X-rays such as to be connected to the isocentric device, according to the present invention;

- figure 6 shows a perspective view of an anti-collision device belonging to the radiant system object of the present invention;

- figure 7 shows the front view of a command and control console model, belonging to the radiant system object of the present invention;

- figures 8A-8C schematically show different perspective views of the system for radiant treatment, in a second embodiment;

- figure 9 shows a schematic view of a motorized hydraulic jack, used inside the isocentric device, according to the present invention;

- figure 10 shows a perspective view of a seat belonging to the radiant system object of the present invention.

With reference to the accompanying figures, the system for the radiation treatment of tumors 1000 comprises an isocentric device, which ? generally indicated with the reference number 100. In detail, the isocentric device, object of the present invention, has specific application in the field of treatment of deep tumors, such as, by way of example, tumors of the oral rim and can be installed, for example, in therapy rooms.

The aforementioned device 100, as visible in figure 1, advantageously comprises an accelerator machine, such as a proto-synchrotron or hadron collider, capable of generating two beams of independent and heteroplanar charged particles in space, capable of irradiating from different angles a point defined as isocenter, in order to center the target volume (VB) of the tumor. In particular, the isocenter ? a geometric point, identified during the centering phase of the device in question, to which a Target Volume (or tumor volume) is subsequently referred.

The aforesaid accelerator machine, in preferred but non-limiting embodiments, is made of materials such as titanium and/or carbon fiber and/or meta-materials. Advantageously, the aforesaid materials are able to make a device resistant to the stresses undergone during any radiotherapy treatments, without undergoing any type of deformation in its structure. In particular, materials such as titanium and carbon fiber are of the borrowed type and are used today in aeronautical technology. Meta-materials, on the other hand, are experimental materials, right? used in modern construction, for example, as anti-seismic materials, since, in the presence of mechanical stress, they tend to recover their physical form. Furthermore, meta-materials, thanks to their intrinsic characteristics, are also used in further applications, such as, by way of example, optics, physics, geometry, electrology, magnetism and physical and clinical dosimetry.

The meta-material can? be used for the creation of dosimeters and experimental ionization chambers why? able to change its properties? dosimetric when in interaction with beams of X-rays, electrons and protons. Other important properties of meta-materials concern experimental chemistry (organic, inorganic, biological) and medical applications, such as the production of orthopedic prostheses, heart valves, blood vessels, etc. Furthermore, in future applications, they could be used to produce collimators of the multileaf or multi-lamellar type, using 3D printers.

Furthermore, the isocentric device 100 comprises a first grantry 10 and a second gantry 11 of the isocentric and rotating type (figure 1).

The gantries 10 and 11 are mutually concentric and, in particular, from a structural point of view, the center of each gantry, respectively the first center C1 and the second center C2, as visible in figure 1, are located on the same axis A, parallel to the ground. Furthermore, the two gantries 10, 11 are independent of each other and have, respectively, the first one, a preferably curved and hollow profile, substantially in the shape of a circumferential crown, while the second, a profile, also curved and hollow, substantially in the shape of a crown of semicircle. Advantageously, the two gantries 10 and 11 translate, independently of each other, on a track 20, which is placed, preferably, on the support surface of the device 100 and which ? coinciding with an X axis lying on the aforementioned plane. Further, advantageously, the aforementioned gantries 10 and 11 can rotate freely, again independently of each other, through angles between 0? and 360?, according to a verse R that can? be both clockwise and counterclockwise with respect to the Z axis, perpendicular to the aforementioned X axis and therefore to the plane, as well as? of angles between 0? and 360?, with respect to the first and second centers C1, C2, according to a direction L, which can? be both clockwise and counterclockwise.

In particular, the gantries 10 and 11 translate and rotate around their main axes of inertia, i.e. the aforementioned X axis, lying on the plane, and the aforementioned Z axis, perpendicular to the plane.

Generally, the movements of the device 100, in preferred embodiments, are performed by electromagnetic induction propulsors, for example of the mAGLEV type (not visible in the figures), which have a magnetic bearing; this technology? already in use for some ?levitation? in operation in Germany and Japan. In this way, advantageously, the mechanical parts that make up the device 100 are moved without friction thanks to the aforementioned magnetic bearing and, therefore, without consequent thermal gradients.

In the engineering phase of an industrial prototype of the device 100 ? useful to determine the best mechanical isocenter, indicated as the meeting point of all and only the N plane motions defined in the R3 space of all the mechanical components of the machine and which, for geometric precision, could be collimated at the physical center of the therapy room. The N plane motions in question are all and only the families of Lissajous curves defined by the following equations:

(1) x= Ax cos (wxt ?x) y=Ay sin(wyt+?y)

Z=Az sin(wzt+?z)

where the above equations (1) refer to the index N (with 1 ? N ? M-1) of all and only plane motions and where amplitudes, phases and pulsations depend on physical parameters in general and mechanical ones in particular. The (1) are the parametric equations of a family of isocentric ellipses.

For each composition of motions (translations, rotations) relating to the various mechanical, physical and electronic components, the isocenter of multiple oscillation lies on the straight line which unites the centers of all the ellipses of the family, in the geometric system of foci and horizontal diameters and transverse.

Still advantageously, coupled to the electromagnetic induction propulsion system, there are particular digital circuits able to reverse the forward movement of the mechanical parts, for example of the two gantries 10 and 11, when they move along the X axis. Again the aforementioned digital circuits they are able to allow the rotational motions of the isocentric device 100, stabilized by optical gyroscopes and/or lasers and/or optical fibres. In further embodiments, other digital interfaces for producing and stabilizing the motions of the device 100 are represented by solid-state and meta-material seismometers and accelerometers.

Furthermore, the aforesaid gantries 10 and 11 have, connected via removable coupling means 121 and 131, respectively, a first and a second collimated rotating head 12 and 13, which are mutually independent and able to rotate in the aforesaid gantries 10 and 11 substantially along the respective circumferences and semicircles, so as to selectively center and irradiate the deep tumor target volume (VB) (figures 1, 2A and 2B).

Advantageously, the accelerator machine launches inside the first and second gantry 10, 11 two beams, for example, of hadrons (protons, light ions, neutrons) of high energy and from here they are guided towards the two collimated warheads 12, 13 .

Again advantageously, compared to conventional treatments with high energy X-ray photons and electrons, hadrons have indisputable advantages. In fact, the energies involved are much more? high (up to 200/250 MeV against the maximum 25 MeV of X-ray photons and up to 15 MeV of electrons); there? allows a more deep penetration into the equivalent biological tissue (about 15 cm) and a greater release (about 100%) on the Target Volume only, thus safeguarding the adjacent healthy tissues, with a significant increase in the Relative Biological Effectiveness (EBR) and a significant reduction in of exposure.

The device 100, in preferred embodiments, also comprises of the units? lateral X-rays 14, as visible in figure 5 (120 kV, 10 mA), for diagnostic use, with photostimulable plates, and mobile laser sources placed on the ceiling, for example, of the therapy room which have the purpose of identifying the? exact physical-geometric isocenter of the device 100 on which to collimate the target volume, as a final check, before treatment.

The hadron beam transport system ? advantageously consisting of electromagnetic dipoles and/or quadrupoles or analyzer magnets (also not visible in the figures) suitably cooled with liquid helium, integrated by an ultra-fine, optoelectronic alignment and collimation system with super lenses (preferably made of metamaterials) and pulse-guided laser beams.

In an advantageous way, considering the multiplanarity? of all the motions described, the system 1000 also includes? a tomograph for Nuclear Magnetic Resonance (RMN) such as to allow a more? easy acquisition of the Target Volume (VB) or the volume of the tumor that must be centered by the beam of ionizing radiation. The aforementioned tomograph has dedicated coils and a relative modified software for the acquisition and piloting of a 3D printer, also included? in the 1000 system, in order to obtain a quality imaging. In particular, the 3D printer advantageously receives the acquired tumor data through a fast graphene-silicon fiber optic transmission line. Advantageously, through the use of a meta-material polymer which varies its chemical-physical and dosimetric characteristics when it interacts with a beam of accelerated protons, the printer faithfully reproduces a cast of the target volume.

The tomograph, again through a fast graphene-silicon data communication line, sends each data relating to the tumor to a unit of robotic isocentric simulation 300. In particular, advantageously, the aforementioned unit? of robotic simulation ? a robot of the Cartesian type, isocentric, with N degrees of freedom? and M multiple joints, of known Lagrangian, whose constituent materials are titanium, carbon fiber and meta-materials (figures 42 and 4B).

The unit 300 comprises induction motors, laser sources and dosimeters specially arranged along the relative main axes of inertia. Inside the unit? 300 ? present, in an advantageous way, a microprocessor, of the EPROM type, which ? used for processing all the data coming from external peripherals (for example Bluetooth? unit for remote control, RMN etc.); moreover, the rotating elements belonging to the unit? 300 are stabilized by special interference laser gyroscopes. The unit 300 simulates all the linear and angular movements of the device 100 as a whole and its isocenter corresponds to the isocenter of the device 100 itself. In preferred embodiments, the unit? robot 300 advantageously also includes digital devices for measuring angles (eg goniometers), distance (eg telemeters) and displacement in the three dimensions of space with respect to the isocenter. These devices can be implemented, in further embodiments, also in the device 100; each data can? what? be processed by the internal EPROM memory of the unit? 300 and sent to a console 16 (figure 7) of the device 100 via a graphene-silicon communication line.

In particular, the control console 16 of the device 100, in preferred embodiments, has a series of devices such as to allow the healthcare personnel to monitor in a ?Real Time? all phases of the treatment, from the acquisition of images with tomograph to MRI, to the remote control of the 3D printer and of the unit? 300 robotic centering and simulation.

As mentioned, the console 16 also controls the treatment phases, for example, opening and closing of the accesses to the room, any interruptions in the safety of the treatment, necessary checks even during the treatment, modalities? of treatment, etc. Furthermore, the personnel in charge, through the aforementioned command console, can? advantageously check the accelerator machine and all the devices connected to it, the quality? of radiant beams, etc.

The calculation of the Target Volume is placed at the isocenter on a special support of the unit? 300, which carries out all the movements (angular and linear) and irradiates the cast with a beam of ionizing radiation, in particular hadrons, providing the calculation of all the physical, geometric, dosimetric and mechanical parameters of the treatment. All these data are sent, through a suitable fast data communication line, to the console of the device 100 for the realization of a customized digital chip, of which ? It is possible to keep a backup copy, which stores each data and which is delivered to the patient. Advantageously, the same patient can deliver the chip, at each session, to the staff in charge. Inserted in a special reader, the chip pu? manage the opening of the doors of the therapy room, the isocenter positioning of the device 100 and any safety procedure to be applied in the event of a system failure. By way of example only, a list of the data that can be inserted in the aforementioned chip is the following:

- Personal data with digital signature of the patient;

- Photo of the patient in digital format;

- Personal password of the patient;

- Clinical reports that can be updated by the medical oncology department and organ specialist treatment departments;

- Updatable findings and reports from the Analysis Clinic;

- Updatable findings and reports of radiology and nuclear medicine services;

- Dosimetric evaluations, therapeutic strategies adopted and their variations by the radiotherapy and health physics services;

- updatable calendar of sessions, dose per session and residual dose;

- Time changes, absences, recoveries, etc.;

- Physical, geometric and dosimetric parameters of each session and of the entire treatment;

- Subsequent checks calendar;

- Signatures in digital format of the Director of the Radiotherapy Service, of the Director of Health Physics, of the Physician responsible for the treatments, of the radiology technical coordinator, of the radiotherapy service and of the Medical Director of the site.

In preferred embodiments, the system 1000 also comprises a quantum computer, in such a way as to be able to store and manage, with appropriate speed, millions of data (mechanical, electrical, electronic, etc.), many of which are interconnected. Advantageously, a quantum computer (or quantum) ? a new device for the treatment and processing of information which, to perform the classic operations on data, uses the typical phenomena of quantum mechanics, such as the superposition of effects and entanglement. These properties? make it much more faster than a traditional computer and the dedicated creation of special software allows for the simultaneous management of all the physical parameters of the entire project.

Furthermore, the system object of the present invention also comprises a seat 30 (figure 1, 4A, 8A, 8B and 10), for example a chair or a bed, of the motorized type, capable of performing angular movements of an angle ? in 90? (position of the seated patient), in which the back of the chair coincides with the Z axis, as defined above, up to 180? (position of the supine patient), along the X axis (parallel to the aforementioned plane), according to the therapeutic needs, as visible in figure 10.

In particular the aforementioned session ? hinged to the supporting surface of the isocentric device 100, on the track 20, and furthermore the seat itself comprises a motorized hydraulic jack (figure 9) to reduce/increase the distance from the floor. The aforementioned jack? advantageously equipped with an induction thruster, while the alignment of the entire jack/chair system? ensured by suitable laser sources located on the seat 30 itself. Session 30? advantageously made of metamaterials, titanium and carbon fiber and, in the various angles, it maintains the isocenter of the entire system without the need for continuous resetting or corrections. Further, again advantageously, the system 1000 and, in particular, the seat 30, in other embodiments, comprises a customized styrenic foam mattress with shape memory, which contains within it a robotic system of mobile laser sensors, which they vary their mutual position with every movement, even infinitesimal and involuntary, of the patient. The movement of these mobile sensors is detected by a particular ceiling laser source which sends the relative data to the quantum computer, which, in turn, automatically corrects the position.

Additionally, the 1000 system ? advantageously equipped with remote measurement and anti-collision systems 15 (figure 6), ie? suitable radiofrequency devices, for example antennas, integrated with optical laser interference sensors and with numerically controlled digital instrumentation, such as rangefinders and digital goniometers arranged on each gantry 10, 11 and on the seat 30, suitable for measuring the mutual variable distance between all elements of the isocentric device 100 in motion. As a possible "critical distance" between the elements approaches, a special chain of cascading relays blocks any rotational and translational movement of the device, interrupting the treatment. The correct calibration of these devices is useful in the experimental phase following the engineering of an industrial prototype.

In a further embodiment, to integrate and/or replace the previously analyzed procedures relating to the centering of the VB and to the simulation of the therapy, it is possible to predict the implementation of reality? virtual (VR) and reality? augmented (AR), which involves the use of information technology to create a simulated environment.

Unlike other traditional user interfaces, VR places the user within a particular experience; instead of viewing information and data on a screen, users are immersed and able to interact with 3D virtual worlds where all the senses can be simulated. By way of example only, in the embodiment in question, the operator can? be connected to the unit? 300 with a Bluetooth? VR type Workstation, teaching the unit? robotized 300 itself all the rotational and translational movements up to the right positioning on the isocenter which ? reportedly the Target Volume reconstructed by the 3D printer.

Additionally, the aforementioned Bluetooth? Workstation, which allows the operator to control and command the unit? robotized 300, is interfaced with the? unit? 300 itself through a parabolic crystalline type screen, of given focus, inside which? inserted a matrix of photodiodes and/or crystals; what has just been said allows, advantageously, to improve the optics of the system and to determine a better complete virtual interaction with the unit? 300 itself, thus facilitating? target volume acquisition procedures.

Particularly, ? Is it possible to use machine learning, a method that "teaches" computers and robots to perform actions and activities? naturally like humans or animals, learning from experience (or rather, through machine learning programs). A machine learning (also known as machine learning) ? a branch of artificial intelligence (Al) which brings together a set of methods, developed since the last decades of the twentieth century in various communities? sciences, under various names, such as computational statistics, pattern recognition, artificial neural networks, adaptive filtering, theory of dynamic systems, image processing, data mining, adaptive algorithms, etc., and which uses statistical methods to progressively improve the performance of an algorithm for identifying patterns in data. Specifically, in the target volume centering procedures (cast in special material created by the 3D printer) and in the simulation of therapy with a special isocentric robot, it can be useful a further check, by the Radiotherapist and/or Health Physics, who, by means of a special VR station, via Bluetooth?, controls all the movements of the unit? robotized 300. The images on the PPI of the VR workstation relating to the Target Volume to be treated are "added" to those coming from the NMR.

In the specific case of oral rhyme tumors, the isocentric system 1000, object of the present invention, also comprises an isocentric device 200 (figures 8A-8C). The aforesaid device comprises a seat 30, which, as mentioned, is able to make angular movements between 90? (position of the seated patient) and 180? (position of the supine patient) along the X axis, depending on the therapeutic needs. The isocentric device 200 comprises a horizontal rotating arm 21, advantageously hinged on a carriage of the accelerator machine, in this case a Linear Accelerator (CLINAC), which supports a first collimated radiant head 22 suitable for emitting electron beams up to 15 MeV.

The horizontal rotating arm 21 performs a rotation from 0? at 270? in a direction E, both clockwise and counterclockwise, around the swing isocenter I, passing through the Z axis perpendicular to the ground (and therefore to the X axis), as visible in figure 8A, following, in the specific case, the contour of the patient's dental arches.

In axis with the head 22? there is a chamber before ionization in solid state and meta-material for the detection of any energetic electrons, which should exceed the given energy.

The device 200 also comprises a vertical rotating arm 211 which supports a second collimated radiant head 23, which emits X-ray photon beams of up to 25 MeV; in line with this? there is a second ionization chamber for X photons. The aforementioned vertical rotating arm 211 performs a rotation from 0? to 360?, according to a direction F that pu? be both clockwise and counterclockwise, around the swing isocenter which coincides with that previously described for the horizontal rotating arm 21.

The ionization chambers are special dosimetric devices useful for detecting photonic (X-Ray, Ray?) and particle (?; ?) radiation. In radiotherapy they are used to detect the dose delivered to the patient and possibly block the isocentric device 200.

Advantageously, the aforementioned system 1000 allows, maintaining the same isocenter and the same horizontal 21 and vertical 211 arms, to irradiate the tumor with two different techniques, using the same apparatus and without needing to move the patient, nor? recalculate the isocenter or dosimetries. In detail, a single tumor volume is irradiated with RX up to 25 MeV, including in the treatment the Complementary Volume, with all the structures adjacent to the tumor itself (adjacent organs, replicas and local recurrences, lymph nodes, etc.); the same is then irradiated with fast electron beams (up to 15 MeV) to provide a dose boost directly on the site of the primary volume (if not operated) and on any surgical wound, for the purpose of local sterilisation.

An example of axial acquisition of sarcoma of the neck is described below, only by way of example.

Phase 1: Acquired and centered all the structures under examination in the three floors of the space, the data is sent to a 3D printer via a fast fiber optic data communication line.

Phase 2: Based on the data received, the 3D printer faithfully reproduces a calculation of the Target Volume (1:1 scale) and the Complementary Volume so? as acquired and centered by MRI.

The cast from the 3D printer can? be built with a meta-material polymer, which varies its properties? physical, chemical and dosimetric when it interacts with a beam of X-ray photons or fast electrons.

Phase 3: Is the cast placed at the isocenter on a special unit? of robotic simulation (called ODONTRON X-im?) quite similar to the unit? real radian and in the same position with respect to the isocenter.

The unit of simulation ODONTRON X-im? ? connected via Bluetooth? with a workstation for reality? advanced virtual machine, which reproduces all the movements of the machine as per indications from the MRI. The radiotherapy team (Health Physicist, Radiotherapist, Radiologist, Organ Specialist, Oncologist) establishes the dose to be administered at Target Volume and Complementary Volume and irradiates the cast. Do the parameters relating to the treatment geometry and dosimetry constitute the TP (Therapy Plan) and will they be processed by the internal processor, for example of the EEPROM type, of the ODONTRON X-im? and sent to the command and control console of the unit? radiating through a fiber optic cable.

The 1000 system, object of the present invention, can? be advantageously installed in an innovative healthcare facility as described below.

The waiting room of the health facility is a very important requirement for the success of the treatments. Must it respond to particular characteristics of hygiene, comfort, brightness, temperature and humidity? (automatic air conditioners), as required by current legislation in general and in consideration of the particular pathologies affecting the patients for whom they are intended (cancer). Internet and WiFi workstations can be integrated to the comfort of the rooms so that? patients and their companions can easily "navigate" according to their personal needs, as well as? background music, a TV room and one for reading the newspapers. For the safety of patients, carers and operators, closed circuit video surveillance should always be active, managed and monitored "real-time" by a special Security Center ready to intervene at any eventuality (even fires), in close collaboration with the of Police and Fire Brigades. Inside them must also? always have adequate toilet facilities, a reception with particularly trained personnel sensitive to the needs and requests of patients, a bar service and vending machines for drinks; moreover, the absence of architectural barriers, slides and sliding doors must be guaranteed, also for emergency exits, to facilitate the entry and exit of patients on stretchers and wheelchairs, and ease access to visiting rooms and medical studies, also with the help of digital indicators, as well as? sober and essential decorative elements (plants, paintings). Also on the ground floor of the building there can also be a store and a bank branch with an ATM automatic teller machine.

A digital queue-eliminator is also proposed, perhaps according to an integrated model with a continuous viewer of images, videos and updatable news bulletins. Toilets are an essential aspect of the efficiency and comfort of a hospital. They will have to respond to specific characteristics of functionality, hygiene and safety. Additionally, there may be sober furnishings, automatic temperature and humidity sensors? ambient light, white LED lighting and ventilation circuit that can be activated automatically when the user enters, fire and smoke sensors connected to the Security Centre, an electromagnetic opening and closing of the entrance door with special flat "touch" switches, a light external free/busy and a button for any emergencies connected to the Security Center also with voice function. The toilets will also be differentiated to be used by disabled patients as well.

Offices should be efficient and elegant workplaces, equipped with elements to promote the efficiency of workers. Essential elements must be: modern desks with computers, printers and roomy and elegant wardrobes. They must also be characterized by brightness? and other comfort parameters.

Another fundamental aspect will be the clinics. In particular, doctors and nurses will work inside the outpatient clinics for the first visits and for subsequent follow-up evaluations of patients who are candidates for radiotherapy treatments with the technology described above. Also in this case, healthy and essential environments will be essential, respectful of privacy and safety, well ventilated and illuminated, with sober and essential furnishings, suitable for a function like this. important for patients and operators.

Present in the health facility in question, the hospitalization, diagnosis and treatment departments must offer an overall capacity of 40/50 beds for the activities clinics for the diagnosis and treatment of oncological diseases that can be treated with the new equipment. The specialties essentially concern the Oncological Radiotherapy, integrated by the activities? clinics of the Medical Oncology Department and the services of conventional Radiological Diagnostics and CT/MRI images, Nuclear Medicine and Health Physics. ? a modern Analysis Laboratory is also planned

The elevators, freight elevators and litter-lifters, as well as the fixed and escalators are preferably of the hydraulic type with safety transfer to the floor in the event of a stop and monitored directly by the Security Center with CCTV surveillance and speakerphone.

? the creation of a logistics platform and van transport for the differentiated automated management of the storage warehouses for hospital and hotel materials is also envisaged. Orders for hospital and hotel materials are preferably differentiated by the logistics warehouse staff and placed by the managers of the various departments and services via e-mail and processed by means of special electric vans to reduce pollution. Even any internal movements of patients and their family members, to and from the hotel structure, are preferably carried out with special cars and/or electric minibuses.

As previously mentioned, the entire hospital area is preferably immersed in an immense green lung, far from urban centers (but well connected to them), which has many and undoubted advantages, both from a physiological and psychological point of view, especially for hospitalized patients. The avenues traveled by cars, minibuses and electric vans must be sufficiently wide, such as to be traveled in complete safety and with cycle-pedestrian lanes on the sides to allow the circulation of pedestrians and cyclists. Also on the sides of the avenues there are some benches.

The following could also be provided:

- a detached university site for theoretical-practical apprenticeships, with multimedia classrooms and laboratories, for the Degree Course in Medicine and Surgery, specialty of Medical Oncology, Oncological Radiotherapy, Medical Radiology and Nuclear Medicine. The schools related to it (Nursing, Speech Therapy, Physiotherapy, Medical Radiology Health Technicians) and/or a Degree Course in Physics with a Health focus could also be located there;

- a multimedia Congress Centre;

- a Kinderheim for children accompanying hospitalized patients;

- a place of worship for the main religious faiths.

A compact accelerator is then used for the production of positrons on site, useful for oncological studies (especially conducted on the brain), through the use of F18 Deoxyglucose, and a positron emission tomograph (PET). For obvious safety reasons, the accelerator machines must be housed in a laboratory sufficiently distant from the rest of the structure, for example in a Department and School of Health Physics.

The classrooms and laboratories of this department will host the accelerators and some university classrooms pertaining to the Specialized Degree Course and PhD in Physics with a Health focus.

A thermo-electric plant with solar energy, consisting of a photovoltaic system with parabolic mirrors, ? advantageously used to supply electrical and thermal energy to all pavilions of the healthcare facility. For security reasons, the control unit can? be otherwise? equipped with generators of continuity? in the event of a power outage (atmospheric perturbations). A security operations center? intended for control and safety to intervene 24/7 in any emergency and danger situation for the entire structure (fire, natural disasters, etc.), in close collaboration with the local Police Forces, the Fire Brigade and the Civil Protection. Staff must also be trained in emergency transfer of patients to other healthcare facilities.

Located at the entrance on the ground floor of the structure, in close collaboration with the Security Operations Centre, a porter and switchboard service has the function of initial reception and sorting of calls to and from the Healthcare Structure. Furthermore, each internal and external part of the proposed Healthcare Facility must be designed to resist earthquakes up to the eighth degree of the Richter Scale, high temperatures (fires), atmospheric electrical discharges (thunderstorms) and flooding of rooms and basements (floods of watercourses, floods from heavy rainfall, etc.).

The materials used must therefore be suitable for these purposes (meta-materials).

From the description given, the characteristics of the system for the radiation treatment of tumors are clear, what is it? object of the present invention, cos? how clear are the advantages.

? Finally, it is evident that numerous other variations can be made to the system in question, without thereby departing from the principles of novelty? inherent in the inventive idea as claimed in the attached claims, as well as how ? it is clear that, in the practical implementation of the invention, the materials, shapes and dimensions of the illustrated details may be any according to the requirements and the same may be replaced with other technically equivalent ones.

Claims (15)

1. System (1000) for the radiation treatment of tumors comprising an accelerator machine, such as a proto-synchrotron or hadron collider, able to generate beams of particles for the centering of a target volume; said system (1000) being installed in a therapy room and being placed on a support surface on which lies a first axis (X), to which ? perpendicular to a second axis (Z), characterized by the fact that it includes: an isocentric device (100) comprising a first gantry (10) and a second gantry (11) mutually isocentric with a substantially curved and hollow profile with, respectively, a first center (C1) and a second center (C2) located on the same third axis (A) parallel to said support plane, in which said first and second gantry (10, 11) translate, independently of each other, on a track (20) coinciding with said first axis (X) and rotate freely through a first angle varying from 0? to 360?, according to a given first direction (R), with respect to said second axis (Z), as well as? of a second angle varying from 0? at 360?, with respect to said first and second center (C1, C2), according to a certain further direction (L); said first and second gantry (10, 11) comprise, respectively, a first and a second collimated rotating head (12, 13) mutually independent and able to rotate in said first and second gantry (10, 11), so as to receive from said accelerator machine said particle beams. 2. System (1000) for the radiation treatment of tumors as claimed in claim 1, characterized in that said particle beams generated by said accelerator machine are high-energy hadrons. 3. System (1000) for the radiation treatment of tumors according to at least one of the preceding claims, characterized in that said device (100) comprises units lateral x-rays including photostimulable plates, for diagnostic use. 4. System (1000) as claimed in claim 1, characterized in that it comprises mobile laser sources located on the ceiling of said therapy room, which have the purpose of identifying the isocenter of said device (100). 5. System (1000) as claimed in claim 1, characterized in that it comprises: - a tomograph for Nuclear Magnetic Resonance able to acquire the imaging of said target volume which must be centered by said radiation beam; - a 3D printer; in which said tomograph also includes? dedicated coils and a software for acquiring and driving said 3D printer for reproducing a calculation of said target volume. 6. System (1000) as claimed in at least one of the preceding claims, characterized in that it comprises a unit? robotized simulation (300) of the isocentric Cartesian type having the same isocenter of said device (100) and being able to simulate all the movements of said device (100), said unit? (300) being connected also? to said tomograph (200) in such a way as to receive data relating to said target volume via a communication line. 7. System (1000) for the radiation treatment of tumors according to at least one of the preceding claims, characterized in that said device (100) and said unit? simulation (300) comprise electromagnetic induction thrusters, of the MAGLEV type, coupled to digital circuits and stabilized by optical gyroscopes and/or lasers and/or optical fibers and/or seismometers and/or solid-state accelerometers and/or meta- materials. 8. System (1000) as claimed in the previous claim, characterized in that said unit? simulation module (300) comprises laser sources and dosimeters, an internal microprocessor, for example of the EEPROM type, digital devices for measuring angles, distances and displacements in the three dimensions of space with respect to said isocenter. 9. System (1000) as claimed in claim 1, characterized in that it comprises a quantum computer and the implementation of reality? virtual and augmented. 10. System (1000) as claimed in claim 1, characterized in that it comprises, hinged to said support surface, at said rail (20), a seat (30), for example a chair or a cot, of the motorized type , capable of performing angular movements of an angle (?) between 90?, along said second axis (Z), and 180?, along said first axis (X), in which said seat (30) comprises a motorized hydraulic jack equipped with an induction thruster whose alignment with said seat (30) ? ensured by laser sources placed on said seat (30). 11. System (1000) as claimed in at least one of the preceding claims, characterized in that said seat (30) comprises a robotic system of mobile laser sensors, which vary their mutual position on the basis of said mobile laser sources positioned on said ceiling. 12. System (1000) as per at least one of the preceding claims, characterized in that it comprises remote measurement and anti-collision systems (15), in particular radio frequency devices, for example antennas, integrated with optical laser interference sensors and instrumentation numerically controlled digital telemeters and digital goniometers, arranged on each of said first and second gantry (10, 11) and on the seat (30), in such a way as to measure the mutually variable distance between all the elements of said isocentric device (100 ) in movement. 13. Method of using said system (1000), according to at least one of claims 1-12, characterized in that it comprises the following steps: A. To acquire, through said tomograph device, data relating to said target volume by sending, via a transmission line, said data to said 3D printer and to said unit? robotic isocentric simulation (300); B. Reproducing, by means of said 3D printer and on the basis of the data received from said tomograph device, a cast of said target volume; C. Position said cast at isocenter on a support of said unit? robotic simulation (300); D. Process, through this unit? of robotic isocentric simulation (300), data relating to said target volume and irradiating said cast with a beam of ionizing radiation, calculating all the physical, geometric, dosimetric and mechanical parameters of said processing; E. Sending said parameters to said console (16) of said device (100) via a communication line; F. Processing said parameters, through said internal processor and sending, through an optical fiber cable, the data of the treatment to be performed to said device (100). 14. Method of using said system (1000) according to the preceding claim characterized in that it comprises, after the step of sending said parameters to said console (16) of said device (100) via a communication line, a step of realizing, through said console (16), a personalized digital chip, which stores said parameters and which ? sent to the patient. 15. A system (1000) for the radiation treatment of tumors, in particular oral rhyme tumors, comprising an accelerator machine, such as a Linear Accelerator (CLINAC), system (1000) characterized in that it comprises an isocentric device (200) having: - a horizontal rotating arm (21) hinged to said accelerator machine; said arm (21) being capable of performing a rotation from 0? at 270? according to a direction (E) around a swing isocenter (I), passing through an axis (Z) perpendicular to the ground, in which said arm (21) ? adapted to support a first collimated radiant head (22) which emits electron beams up to 15 MeV; - a first solid-state and meta-material ionization chamber, aligned with said first head (22), for the detection of any energetic electrons, which should cio? exceed the given energy; - a vertical rotating arm (211) capable of performing a rotation from 0? to 360?, according to a direction (F), around said swing isocenter (I), in which said arm (211) ? adapted to support a second collimated radiant head (23) which emits beams of X-ray photons up to 25 MeV; - a second ionization chamber for X photons, in axis with said second collimated head (23).