Robot for focused ultrasound therapeutic treatments

Abstract

A robot for therapeutic treatments, in particular focused ultrasound ("FUS") therapeutic treatments, comprising a focused ultrasound transducer (2) configured to emit a focused ultrasound beam (3) along an emission direction (4), and an electronic processing unit (8) configured to control the operation of the robot (1).

Description

"ROBOT FOR FOCUSED ULTRASOUND THERAPEUTIC TREATMENTS" DESCRIPTION

[0001] Field of the invention

[0002] The present invention relates to a robot for therapeutic treatments, in particular therapeutic treatments carried out by means of focused ultrasound, also referred to as "focused ultrasound" or "FUS".

[0003] Background art

[0004] Cancer is the second leading cause of death in the world. Worldwide, there were approximately 19.3 million new cancer cases and nearly 10.0 million cancer deaths in 2020. However, survival rates are improving for many types of cancer by virtue of advances in cancer prevention, screening, and treatment. Nowadays, open surgery, laparoscopic surgery, chemotherapy and radiotherapy are well-established approaches to curing cancer.

[0005] However, the current cancer treatments have several critical issues. For example, they are not free from problems of invasiveness and toxicity. Moreover, they require long hospital stays and surgical procedures which can alter living conditions. Moreover, standard cancer treatments are not always effective in treating areas which are difficult to access or inaccessible, and often do not allow re-treating incompletely treated or recurrent cancers. A further drawback is that some standard cancer treatments, such as chemotherapy, require multiple sessions and longer treatment times. Moreover, the equipment and devices used to carry out standard cancer care are highly expensive (radiotherapy equipment can cost more than $3 million).

[0006] A further approach to cancer care is the so-called focused ultrasound (FUS) surgical treatment. FUS treatment includes the use of thermal energy by emitting an ultrasound beam focused on the area to be treated, in particular the tumor mass, to carry out tumor ablation. During the propagation of the wave through the tumor tissue, part of the energy of the focused ultrasound beam, concentrated in a focal zone, is absorbed, leading to an increase in temperature and finally to cell necrosis of the tumor mass portion targeted by the focal zone of the focused ultrasound beam. The size of the tumor mass is often larger than the size of the focal zone, so it is often necessary to carry out a sequence of focused ultrasound emissions, or "sonications", to cause the complete necrosis of the targeted tumor mass.

[0007] FUS treatment has several advantages, including the possibility of intervening on the oncological organs in a totally non-invasive manner, with no toxicity for the patient, short hospitalization times, and the possibility of repeating the treatment on the same day,where necessary. As a result, FUS treatment is considered highly promising and improved with respect to standard cancer care, and thus appears as the ideal surgical treatment for cancer.

[0008] However, the known therapeutic devices and focused ultrasound therapeutic treatments which can be carried out by means of such therapeutic devices still have several critical issues.

[0009] One critical issue of the prior art concerns the coupling between patient and therapeutic device. Specifically, to correctly carry out the therapy, an adequate acoustic coupling between the focused ultrasound transducer and the patient's body must exist, so that the focused ultrasound surgical procedure is safe and efficient. If and only if this coupling occurs, the focused ultrasound beam can propagate correctly from the transducer to the patient's body and reach the therapeutic target. If the coupling is not ensured, it is possible to cause a reduction of treatment efficiency (due to power dissipation), off-target therapeutic beam reflections (resulting in collateral damage to structures which are not to be treated), skin burns (e.g., on the patient's skin), high energy reflections with possible damage to instrumentation (e.g., to the focused ultrasound transducer and ultrasound probe for guiding the therapy).

[0010] Therapeutic devices are known, comprising a degassed water tank within which the focused ultrasound transducer is positioned, and in which the patient is partially immersed or resting above or below the tank. However, this known technology has several problems, including the complexity or impossibility of immersing or reaching certain anatomical areas, poor patient comfort, the need to make the equipment compatible with immersion in water, and the impossibility of approaching the patient from the top downwards.

[0011] Therapeutic devices are also known, comprising a balloon of degassed water mounted on the focused ultrasound transducer which is rested and pressed against the patient's skin so as to attempt to ensure the constant coupling between the device and the patient. Such a device, pressed against the patient's skin with a predetermined constant force, is known from EP2412406B8, for example. However, this known technology also has several problems, including the high complexity in ensuring the correct placement of the balloon on the patient's skin, and the consequent uncertainty of having achieved a correct coupling (there could still be air between the balloon and the skin). Moreover, anatomical and positioning constraints of the therapeutic configuration could lead to an imperfect acoustic coupling between the therapeutic transducer and the patient's skin. Therefore, this would cause a reduction in the efficiency of the focused ultrasoundtreatment. Specifically, if air is interposed in the path of the acoustic beam, the difference in acoustic impedance between the air and the balloon produces up to 99.9% energy reflections. This collateral phenomenon causes a loss of acoustic energy directed to the targeted area and could damage both the patient, mainly with skin burns, as well as the instrumentation, namely the ultrasound probe and the transducer. Moreover, if the target organ moves, for example due to physiological respiration, the transducer will also need to be moved to keep the target focused, and thus maintaining adequate acoustic coupling is even more challenging.

[0012] A further critical issue of the prior art concerns the tracking carried out by the robot of the therapeutic target to be treated. Specifically, in the case of therapies based on the localized release of energy, such as focused ultrasound, it is necessary to track the therapeutic target, i.e. , the zone where the energy is released, and the biologically relevant effect occurs, throughout the treatment duration of that particular target. This is particularly required when the therapeutic target is located in the abdominal cavity, which is particularly prone to movements due to breathing or heartbeat. If the tracking is not carried out, there can be a loss of efficacy of the treatment or a generation of damage in unplanned zones, i.e., healthy tissues which are not intended to be treated.

[0013] Therapeutic devices are known, which approach such critical issues by implementing a temporary suppression of breathing, so as to avoid having to carry out a tracking, however, such an approach generates discomfort for the patient and the impossibility of carrying it out for prolonged periods.

[0014] Therapeutic devices provided with focused ultrasound transducers and a probe are also known, which carry out tracking by means of a so-called steering technique. However, such devices have generally high costs. Moreover, the steering technique has both spatial and temporal limits (low reactivity). Moreover, the tracking carried out by the known therapeutic devices has a low accuracy, critical in maintaining the coupling between the transducer and the patient.

[0015] A further critical issue of the prior art concerns the intra-operative planning of a therapeutic treatment strategy and the implementation thereof. Specifically, intra-operative plans of therapeutic treatment strategies are known, which comprise a step of positioning the imaging device so as to display the therapeutic target, a manual or joystick movement of the imaging device to display the therapeutic plan in different image planes, a manual segmentation of the therapeutic target in different image planes and a definition of a point- by-point ablation strategy or by means of predefined grids.

[0016] However, such intra-operative planning of known therapeutic treatment strategies involves long execution times, for both the manual segmentation and the ablation, poor accuracy, as they have the high risk of not treating target regions or treating healthy regions, and do not consider any movements of the therapeutic target.

[0017] A further critical issue of the prior art relates to the efficacy of the focused ultrasound therapeutic treatment, and thus the certainty regarding the final result of the treatment. In fact, the therapeutic effect consists of a local rise in temperature or alternatively a mechanical cavitation, depending on the specific transducer and generator which generate the focused ultrasound beam, and depending on the driving parameters of these components. In the prior art, under ultrasound guidance, the efficacy of the treatment is evaluated at the end of the execution of the planned treatment, qualitatively, or by visual inspection of images related to the treated area. However, such an approach of the prior art implies the impossibility of mitigating any errors in the therapeutic treatment planning, the impossibility of interrupting or correcting the therapeutic treatment online, and the absence of quantitative verifications of the therapeutic effect produced.

[0018] Solution

[0019] It is the object of the present invention to provide a robot for therapeutic treatments, in particular therapeutic treatments carried out by means of focused ultrasound, which solves at least some of the critical issues highlighted in the prior art.

[0020] It is a particular object of the present invention to provide a robot for medical (on humans) and veterinary (on animals) treatments, in particular by means of focused ultrasound, which ensures a correct, effective and safe coupling between the patient and the focused ultrasound transducer. Specifically, providing a robot which minimizes the risk of losing the coupling with the patient's skin, such as to allow different organs or targets to be treated by the same transducer, which can be manufactured with different materials, not necessarily compatible with being immersed in water, which simplifies reaching the different anatomical zones to be treated, which allows an approach on the patient from the top downwards, which reduces the risk of damaging the patient or the robot itself, and which increases the patient's comfort during the treatment.

[0021] It is a particular object of the present invention to provide a robot for medical (on humans) and veterinary (on animals) treatments, in particular by means of focused ultrasound, which allows tracking a therapeutic target with high accuracy, with short execution times and which minimizes the risk of losing the coupling between the therapeutic device and the patient's body.

[0022] It is a particular object of the present invention to provide a robot for medical (on humans) and veterinary (on animals) treatments, in particular by means of focused ultrasound, which allows carrying out an intra-operative planning of a therapeutic treatment strategy, and implementing such a planned strategy, which has short execution times, as well as high accuracy and safety.

[0023] It is a particular object of the present invention to provide a robot for medical (on humans) and veterinary (on animals) treatments, in particular by means of focused ultrasound, which allows mitigating any errors in planning the therapeutic treatment, interrupting or correcting the therapeutic treatment online, and carrying out a quantitative verification of the therapeutic effect produced.

[0024] These and other objects are achieved by a robot for therapeutic treatments, in particular therapeutic treatments carried out by means of focused ultrasound, according to the independent claim.

[0025] The dependent claims relate to preferred and advantageous embodiments of the present invention.

[0026] Figures

[0027] In order to better understand the invention and appreciate the advantages thereof, some non-limiting exemplary embodiments thereof will be described below with reference to the accompanying drawings, in which:

[0028] - figure 1 is a perspective view of a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment of the invention;

[0029] - figure 2 is a diagrammatic depiction of a robot for medical (on humans) and veterinary (on animals) treatments according to an embodiment of the invention;

[0030] - figure 3 is a diagrammatic depiction of a robot for medical (on humans) and veterinary (on animals) treatments according to an embodiment of the invention;

[0031] - figure 4 is a diagrammatic depiction of a robot for medical (on humans) and veterinary (on animals) treatments according to a further embodiment of the invention;

[0032] - figure 5 is a diagrammatic depiction of a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment of the invention, in a first operating configuration;

[0033] - figure 6 is a further diagrammatic depiction of a robot for medical (on humans) and veterinary (on animals) treatments shown in figure 5, in a second operating configuration;

[0034] - figure 7 is a further diagrammatic depiction of the robot for medical (on humans) and veterinary (on animals) treatments shown in figure 5, in a third operating configuration;

[0035] - figure 8 is a further diagrammatic depiction of the robot for medical (on humans) and veterinary (on animals) treatments shown in figure 5, in a fourth operating configuration;

[0036] - figures 9, 10, 11 are diagrammatic depictions of a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment of the invention, in different operating configurations;

[0037] - figure 12 is a diagrammatic depiction of a step of a method which can be carried out by a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment;

[0038] - figure 13 is a further diagrammatic depiction of a step of a method which can be carried out by a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment;

[0039] - figure 14 is a further diagrammatic depiction of a step of a method which can be carried out by a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment;

[0040] - figure 15 is a further diagrammatic depiction of a step of a method which can be carried out by a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment;

[0041] - figure 16 is a depiction of a step of a method which can be carried out by a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment;

[0042] - figure 17 is a diagrammatic depiction of a step of a method which can be carried out by a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment;

[0043] - figure 18 is a further diagrammatic depiction of a step of a method which can be carried out by a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment;

[0044] - figure 19 is a further diagrammatic depiction of a step of a method which can be carried out by a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment;

[0045] - figure 20 is a further diagrammatic depiction of a step of a method which can be carried out by a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment;

[0046] - figure 21 is a depiction of a step of a method which can be carried out by a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment;

[0047] - figure 22 is a depiction of a step of a method which can be carried out by a robot for medical (on humans) and veterinary (on animals) treatments, according to an embodiment.

[0048] Description of some preferred embodiments

[0049] With reference to the figures, a robot for therapeutic treatments, in particular focused ultrasound ("FUS") therapeutic treatments, is generally indicated by reference numeral 1.

[0050] The robot 1 comprises a focused ultrasound transducer 2.

[0051] The transducer 2 is configured to emit a focused ultrasound beam 3, along an emission direction 4. In particular, the emission direction 4 can be directed towards a patient’s skin 5.

[0052] The beam 3 of focused ultrasound converges in a focus 6.

[0053] During the treatment, the focus 6 of the beam 3 is positionable at a therapeutic target 7, e.g., a tumor mass.

[0054] The emission direction 4 is substantially definable by an axis transverse to the transducer 2 and intersecting the focus 6.

[0055] The robot 1 comprises an electronic processing unit 8, configured to control the operation of the robot 1.

[0056] According to an embodiment, the robot comprises at least one robotic arm 9, configured to move the transducer 2. For example, by means of the robotic arm 9 the transducer 2 is movable towards or away from the patient's skin 5.

[0057] Specifically, the robotic arm 9 comprises a head end 10 and an opposite foot end 11. The head end 10 is movable, while the foot end 11 is generally fixed with respect to the patient. The transducer 2 is connected to the robotic arm 9 at the head end 10 of the robotic arm 9.

[0058] According to an embodiment, the robot 1 comprises a head body 12. The head body 12 is positioned at the head end 10 of the robotic arm 9. The transducer 2 is connected to the head body 12 of the robot 1.

[0059] According to an embodiment, the robotic arm 9 is configured to move the transducer 2, for example towards or away from the patient's skin 5.

[0060] According to an embodiment, the robotic arm 9 is positioned at the head body 12 of the robot 1.

[0061] According to an embodiment, the transducer 2 comprises an emission wall 13. The emission wall 13 faces the patient's skin 5. The emission wall 13 is concave with respect to the patient's skin 5. Thereby, the emission wall 13 is configured to converge the beam 3 in a focus 6 directed towards the patient’s skin 5.

[0062] Coupling system 100

[0063] According to an embodiment, the robot 1 comprises a coupling system 100.

[0064] The coupling system 100 is configured to make a coupling between the transducer 2 and a patient, in particular between the transducer 2 and the patient's skin 5.

[0065] The coupling system 100 comprises a coupling membrane 101.

[0066] The coupling membrane 101 is fixable to the transducer 2 so as to extend along the emission direction 4, all around the beam 3 emanable by the transducer 2.

[0067] The coupling membrane 101 comprises an adhesion crown 103.

[0068] The adhesion crown 103 is configured to be connectable to the patient's skin 5 and adhere to the patient's skin 5.

[0069] Thereby, the coupling membrane 101 defines a coupling channel 104 extending between the transducer 2 and the adhesion crown 103.

[0070] Specifically, the transducer 2 is configured to emit the beam 3 across the coupling channel 104, past the adhesion crown 103 and the skin 5, and converge into the focus 6 at the therapeutic target 7.

[0071] Specifically, the coupling membrane 101 comprises a fixing end 102, opposite the adhesion crown 103. The fixing end 102 is fixed to the transducer 2. Preferably, the fixing end 102 is reversibly fixable to the transducer 2.

[0072] The coupling system 100 further comprises a pneumatic pumping system 105.

[0073] The pneumatic pumping system 105 is configured to generate a vacuum inside the coupling channel 104.

[0074] Specifically, the pneumatic pumping system 105 is configured to generate a vacuum inside the coupling channel 104 when the adhesion crown 3 is connected to the patient's skin 5.

[0075] Thereby, when the pneumatic pumping system 105 generates the vacuum within the coupling channel 104, the adhesion crown 103 adheres to the patient's skin 5. Moreover, the adhesion crown 103 exerts a suction force on the patient's skin 5, directed from the patient's skin 5 towards the transducer 2.

[0076] Advantageously, a coupling system 101 thus configured ensures a correct, effective and safe coupling between the patient and the focused ultrasound transducer 2. In fact, by means of the suction force generated by the adhesion crown 103, the risk oflosing the coupling with the patient's skin is minimized. Moreover, such a coupling system 101 does not require immersing in water neither the robot 1 , nor the transducer 2 in the entirety thereof, nor the patient, and allows approaching the patient from top downwards, therefore it does not require that the robot 1 or the transducer 2 be manufactured with materials suitable for a complete immersion in water and simultaneously increases the patient’s comfort during the treatment.

[0077] According to an embodiment, the pneumatic pumping system 105 is configured to make a pneumatic vacuum between the suction crown 103 and the patient’s skin 5. Therefore, the pneumatic pumping system 105 is configured to empty the air from inside the coupling membrane 101 substantially completely.

[0078] According to an embodiment, the pneumatic pumping system 105 is a compressor or a vacuum pump.

[0079] According to an embodiment, the pneumatic pumping system 105 comprises a suction duct 108.

[0080] The suction duct 108 is extended at the adhesion crown 103, in fluid connection with the interface between the adhesion crown 103 and the patient's skin 5.

[0081] The suction duct 108 is configured to suck air exiting from the adhesion crown 103, in particular from the interface between the adhesion crown 103 and the patient's skin 5, so as to generate a vacuum between the adhesion crown 103 and the patient's skin 5, thereby generating a suction on the patient's skin 5 by the adhesion crown 103.

[0082] According to an embodiment, the coupling membrane 101 is a flexible or deformable membrane.

[0083] According to a preferred embodiment, the coupling membrane 101 is an extensible, thus elastically deformable membrane. According to an embodiment, the coupling membrane 101 is made of polymeric material.

[0084] Advantageously, a coupling membrane 101 thus configured allows treating different organs or therapeutic targets 7 by means of a same transducer 2. In fact, by means of a coupling membrane 101 thus configured, in order to localize the focus 6 of the beam 3 on therapeutic targets 7 located at different depths, with reference to the patient’s skin 5, it is not necessary to use different transducers 2 making the focus 6 at different depths or distances from the transducer 2, but the same transducer 2 is usable, which makes the focus 6 at a predetermined depth, and approaches or distances the transducer 2 from the patient’s skin 5, by deformation or bending of the coupling membrane 101 thus configured, and localizing the focus 6 at a therapeutic target 7 more or less close to the patient’s skin 5, with a consequent reduction in the time and complexity of the treatment.In fact, in general, each transducer 2 has a nominal focal distance thereof, i.e., a certain nominal distance between the transducer 2 and the focus 6. Therefore, the coupling system 100 thus configured allows using a same transducer 2, having a certain nominal focal distance, to treat therapeutic targets 7 at different depths.

[0085] With further advantage, a coupling membrane 101 thus configured allows easily accommodating periodic movements of the patient’s skin 5 with respect to the transducer 2, for example along the emission direction 4, and in particular due to natural respiration or heartbeat, as well as any non-periodic movements. Indeed, the suction force made by the adhesion crown 103 allows a relative movement of the coupling membrane 101 with respect to the patient's skin 5, preserving the adhesion between the adhesion crown 103 and the patient's skin 5.

[0086] According to an embodiment, the coupling system 100 comprises a hydraulic pumping system 106.

[0087] The hydraulic pumping system 106 is configured to convey a coupling liquid 107 into the coupling channel 104. Moreover, the hydraulic pumping system 106 is configured to convey the coupling liquid 107 in output from the coupling channel 104.

[0088] Specifically, the hydraulic pumping system 106 is configured to convey the coupling liquid 107 into the coupling channel 104 when the coupling membrane 101 is connected by adhesion to the patient's skin 5 by means of the adhesion crown 103, so as to fill the coupling membrane 101 with the coupling liquid 107. Thereby, the coupling liquid 107 extends continuously from the transducer 2 to the adhesion crown 103, and thus to the patient's skin 5.

[0089] In accordance with this embodiment, the beam 3 is emanable from the transducer 2 through the coupling liquid 107 contained in the coupling membrane 101.

[0090] Advantageously, the complete filling of the coupling membrane 101 with the coupling liquid 107 allows avoiding dispersions of the power of the focused ultrasound beam 3, as well as avoiding reflections of the beam 3 which could harm the patient or the robot 1 .

[0091] With further advantage, the hydraulic pumping system 106 allows modifying the content of coupling liquid 107 inside the coupling membrane 101 , so as to allow deformations of the coupling membrane 101. For example, if the transducer 2 is requested to be brought closer to the patient’s skin 5, and then compressing the membrane 101 or otherwise reducing the volume of the coupling channel 104, the hydraulic pumping system 106 conveys the coupling liquid 107 out of the coupling membrane 101. Conversely, if it is required to distance the transducer 2 from the patient's skin 5, and thus extend themembrane 101 or otherwise increase the volume of the coupling channel 104, the hydraulic pumping system 106 conveys the coupling liquid 107 into the coupling membrane 101.

[0092] According to an embodiment, the robot 1 and the hydraulic pumping system 106 are controllable by the electronic processing unit 8, so as to preserve the complete filling of the coupling membrane 101 with the coupling liquid 107, during any relative movements between the transducer 2 and the patient's skin 5.

[0093] According to an embodiment, the coupling liquid 107 is a degassed liquid.

[0094] According to an embodiment, the coupling liquid 107 is degassed water.

[0095] According to an embodiment, the coupling liquid 107 contained inside the coupling channel 104 is at ambient pressure.

[0096] According to an embodiment, the hydraulic pumping system 106 comprises a hydraulic inlet duct 109 and a hydraulic outlet duct 110.

[0097] The hydraulic inlet duct 109 and the hydraulic outlet duct 110 extend into the coupling channel 104, in fluid connection with the coupling channel 104.

[0098] The hydraulic inlet duct 109 is configured to convey the coupling liquid 107 to enter in the coupling channel 104, so as to fill the coupling channel 104 with the coupling liquid 107, which will then be contained within the coupling membrane 101.

[0099] The hydraulic outlet duct 110 is configured to convey the coupling liquid 107 out of the coupling channel 104.

[0100] Advantageously, such a configuration allows cooling the patient's skin 5 during the therapeutic treatment. Indeed, during the therapeutic treatment, the coupling liquid 107 contained in the coupling membrane 101 is heated by the focused ultrasound beam 3 transmitted through the coupling liquid 107. Such a hydraulic pumping system 106 thus configured allows carrying out a recirculation of the coupling liquid 107 contained in the coupling membrane 101 , so as to replace the coupling liquid 107 heated by the beam 3 inside the coupling membrane 101 with cooled coupling liquid 107, or with new coupling liquid 107 at a lower temperature.

[0101] According to an embodiment, the coupling system 101 comprises a cooling unit 111. The cooling unit 111 is fluidly connected with the hydraulic pumping system 106. The cooling unit 111 is configured to receive the hot coupling liquid 107 from the coupling membrane 101 , cool the coupling liquid 107, and convey the cold coupling liquid 101 toward the coupling membrane 101. The terms "hot" and "cold" do not identify certain temperatures, but are intended to identify a relationship between the temperature of thecoupling liquid 107 entering the cooling unit 111 and the coupling liquid 107 exiting the cooling unit 111.

[0102] According to an embodiment, the coupling system 101 comprises a degassing unit 115. The degassing unit 115 is fluidly connected with the hydraulic pumping system 106. The degassing unit 115 is configured to receive the coupling liquid 107 from the coupling membrane 101 , degas the coupling liquid 101 , thus eliminating any gaseous substances dissolved in the coupling liquid 107, and convey the degassed coupling liquid 101 toward the coupling membrane 101.

[0103] According to an embodiment, the hydraulic inlet duct 109 and the hydraulic outlet duct 110 are separate and distinct ducts.

[0104] According to an alternative embodiment, the hydraulic inlet duct 109 and the hydraulic outlet duct 110 are a same duct, configured to convey the coupling liquid 107 into or out of the coupling channel 104.

[0105] According to an embodiment, the hydraulic inlet duct 109 and the hydraulic outlet duct 110 extend into the coupling channel 104.

[0106] According to an embodiment, a conveying end of the hydraulic inlet duct 109 is positioned at the adhesion crown 103. According to an embodiment, a conveying end of the hydraulic outlet duct 110 is positioned at an interface between the transducer 2 and the coupling membrane 101. Specifically, the conveying end of the hydraulic outlet duct 110 is positioned at the fixing end 102 of the coupling membrane 101.

[0107] Specifically, a conveying end of the hydraulic inlet duct 109, at which the coupling liquid 107 conveyed into the hydraulic inlet duct 109 flows into the coupling channel 104, is positioned at the adhesion crown 103, thus at the patient's skin 5 when the coupling membrane 101 adheres to the patient's skin 5. Moreover, a conveying end of the hydraulic outlet duct 110, at which the coupling liquid 107 is conveyed out of the coupling channel 104 into the hydraulic outlet duct 110, is positioned at an end of the coupling membrane 101 fixed to the transducer 2 and opposite the adhesion crown 103.

[0108] Advantageously, such a configuration facilitates the recirculation of the coupling liquid 107 within the coupling membrane 101. In fact, during the heating of the coupling liquid 107 contained in the coupling membrane 101 , the portion of coupling liquid 107 at a higher temperature, and thus to be replaced, will rise by convection at the interface between the transducer 2 and the coupling membrane 101 , at the fixing end 102, where the conveying end of the hydraulic outlet duct 110 is positioned, which can then easily extract the hotter coupling liquid 107 from the coupling channel 104. Conversely, such aconfiguration allows the cooler coupling liquid 107 to be conveyed at the adhesion crown103, and thus at the patient's skin 5 which needs to be cooled to avoid damage.

[0109] According to an embodiment, the coupling system 100 comprises an emptying system 112.

[0110] The emptying system 112 comprises a hydraulic emptying duct 113.

[0111] The hydraulic emptying duct 113 is fluidly connected with the coupling channel104.

[0112] The emptying system 112 is configured to empty the coupling membrane 101 of the coupling liquid 107 contained in the coupling channel 104.

[0113] Specifically, the hydraulic emptying duct 113 is configured to convey the coupling liquid 107 to exit from the coupling channel 104.

[0114] According to an embodiment, the hydraulic emptying system 112 is distinct from the hydraulic pumping system 106. Therefore, the hydraulic emptying duct 113 is distinct from the hydraulic outlet duct 110.

[0115] Advantageously, the hydraulic emptying system 112 allows the coupling liquid 107 to be easily emptied from the coupling membrane 101 at the end of the therapeutic treatment.

[0116] With further advantage, a coupling system 100 thus configured allows the coupling liquid 107 to be quickly emptied from inside the coupling membrane 101 if necessary, for example if the temperature of the coupling liquid 107 exceeds a danger threshold value for the patient. With further advantage, by means of the hydraulic emptying duct 113, the coupling liquid 107 emptied in an emergency is easily and safely conveyed out of the coupling membrane 101 , avoiding the risk of spilling the coupling liquid 107 onto the patient's skin 5.

[0117] According to an embodiment, a suction end of the hydraulic emptying duct 113 is positioned at the adhesion crown 103. Therefore, the suction end of the hydraulic emptying duct 113 is positioned near the patient's skin 5.

[0118] Advantageously, such a configuration allows emptying, in an emergency, the coupling liquid 107 starting from the portion of coupling liquid 107 located at the patient's skin 5, i.e. , at the adhesion crown 103, thus making a flow of the coupling liquid 107 at the patient's skin 5, which by convection favors a cooling of the patient's skin 5, and thus avoids a stagnation of the coupling liquid 107 on the patient's skin 5 during the emergency emptying of the coupling liquid 107.

[0119] According to an embodiment, the coupling system 100 comprises at least one coupling sensor 114. Preferably, the coupling system 100 comprises a plurality of coupling sensors 114.

[0120] The at least one coupling sensor 114 is configured to detect and monitor at least one parameter of the coupling system 100.

[0121] According to an embodiment, the at least one coupling sensor 114 is configured to detect one or more physical parameters related to the coupling system 100. According to an embodiment, the at least one coupling sensor 114 is configured to detect the air pressure possibly present inside the coupling crown 103, in particular at the interface between the coupling crown 103 and the patient's skin 5. According to an embodiment, the at least one coupling sensor 114 is configured to detect the pressure of the coupling liquid 107 inside the coupling channel 104. According to an embodiment, the at least one coupling sensor 114 is configured to detect the temperature of the coupling liquid 107 inside the coupling channel 104. According to an embodiment, the at least one coupling sensor 114 is configured to detect the presence of gaseous substances dissolved in the coupling liquid 107. According to an embodiment, the at least one coupling sensor 114 is configured to detect the deformation or bending of the coupling membrane 101.

[0122] Advantageously, the parameters, values and variables detected by the one or more coupling sensors 114 are usable by the electronic processing unit 8 to determine the possible need to generate a vacuum or a pneumatic vacuum inside the adhesion crown 103, in particular at the interface between the adhesion crown 103 and the patient's skin 5, or to increase or decrease the pressure of the coupling liquid 107 inside the coupling membrane 101 , or to cool or recirculate the coupling liquid 107 contained in the coupling membrane 101 , or to degas the coupling liquid 107, or to adjust the movement of the transducer 2 as a result of the deformation or bending of the coupling membrane 101 , in particular following a movement of the transducer 2 and the coupling membrane 101 by means of the robotic arm 9.

[0123] According to an embodiment, the at least one coupling sensor 114 is connected to the coupling membrane 101. According to an embodiment, the at least one coupling sensor 114 is positioned on the coupling membrane 101 , facing the coupling channel 104. According to an embodiment, the at least one coupling sensor 114 is embedded inside the coupling membrane 101. According to an embodiment, the at least one coupling sensor 114 is positioned at the adhesion crown 103. Advantageously, such a configuration allows easily detecting the parameters of the portion of coupling liquid 107 near the patient's skin 5.

[0124] Advantageously, a coupling system 100 as described above is usable to couple a transducer 2 to the patient’s skin 5, so that a non-invasive therapeutic treatment can then be carried out.

[0125] According to an embodiment, the transducer 2 is connected to a laparoscopic instrument 116. Moreover, the coupling system 100 is connectable to the transducer 2.

[0126] Advantageously, the coupling system 100 as described above can be used to couple a transducer 2 to the target organ containing the therapeutic target 7, so that it can then carry out a minimally invasive therapeutic treatment, by means of the use of a laparoscopic instrument 116 associated with the transducer 2.

[0127] According to an embodiment, a method for coupling a focused ultrasound transducer 2 with a patient, preferably with a patient’s skin 5, by means of a coupling system 100 as previously described, comprises a step of positioning the transducer 2 at the patient’s skin 5.

[0128] Moreover, the method comprises a step of fixing the coupling membrane 101 to the transducer 2. Specifically, the fixing end 102 of the coupling membrane 101 is fixed to the transducer 2.

[0129] Moreover, the method comprises a step of positioning the adhesion crown 103 on the patient’s skin 5.

[0130] Moreover, the method comprises a step of generating a vacuum, preferably a pneumatic vacuum, inside the adhesion crown 103, by means of the pneumatic pumping system 105. Such a step of generating vacuum, preferably pneumatic vacuum, generates an adhesion of the adhesion crown 103 to the patient's skin 5.

[0131] According to an embodiment, following the step of generating vacuum, preferably pneumatic vacuum, the method comprises a step of filling the coupling membrane 101 with coupling liquid 107, by means of the hydraulic pumping system 106. The coupling liquid 107 is preferably degassed water.

[0132] Optionally, the method comprises a step of detecting and monitoring one or more physical parameters related to the coupling system 100, by means of one or more coupling sensors 114.

[0133] Optionally, the method comprises a step of adjusting the coupling between the transducer 2 and the patient's skin 5, by means of the electronic processing unit 8. The step of adjusting the coupling between the transducer 2 and the patient's skin 5 can comprise a step of activating the recirculation of the coupling liquid 107 by means of the hydraulic pumping system 106, or a step of cooling the coupling liquid 107 by means of the cooling unit 111 , or a step of degassing the coupling liquid 107 by means of thedegassing unit 115, or a step of filling or emptying the coupling channel 104, by means of the hydraulic pumping system 106 or the emptying system 112.

[0134] Optionally, the method comprises a step of moving the transducer 2 and / or the coupling membrane 101 by means of the robotic arm 9.

[0135] According to an embodiment, the method comprises a step of emptying the coupling liquid 107 from the coupling membrane 101 , by means of the emptying system 112.

[0136] According to an embodiment, a method for carrying out a focused ultrasound therapeutic treatment on a patient by means of a robot 1 comprises a step of positioning the transducer 2 at the patient's skin 5.

[0137] Moreover, the method comprises a step of fixing the coupling membrane 101 to the transducer 2. Specifically, the fixing end 102 of the coupling membrane 101 is fixed to the transducer 2.

[0138] Moreover, the method comprises a step of positioning the adhesion crown 103 on the patient’s skin 5.

[0139] Moreover, the method comprises a step of generating a vacuum, preferably a pneumatic vacuum, inside the adhesion crown 103, by means of the pneumatic pumping system 105. Such a step of generating vacuum, preferably pneumatic vacuum, generates an adhesion of the adhesion crown 103 to the patient's skin 5.

[0140] Moreover, following the step of generating vacuum, preferably pneumatic vacuum, the method comprises a step of filling the coupling membrane 101 with coupling liquid 107, by means of the hydraulic pumping system 106. The coupling liquid 107 is preferably degassed water.

[0141] Moreover, following the filling of the coupling membrane 101 with the coupling liquid 107, the method comprises a step of emitting a beam 3 of focused ultrasound converging on a focus 6 positionable at a therapeutic target 7.

[0142] Optionally, the method comprises a step of detecting and monitoring one or more physical parameters related to the coupling system 100, by means of one or more coupling sensors 114.

[0143] Optionally, the method comprises a step of adjusting the coupling between the transducer 2 and the patient's skin 5, by means of the electronic processing unit 8. The step of adjusting the coupling between the transducer 2 and the patient's skin 5 can comprise a step of activating the recirculation of the coupling liquid 107 by means of the hydraulic pumping system 106, or a step of cooling the coupling liquid 107 by means of the cooling unit 111 , or a step of degassing the coupling liquid 107 by means of thedegassing unit 115, or a step of filling or emptying the coupling channel 104, by means of the hydraulic pumping system 106 or the emptying system 112.

[0144] Optionally, the method comprises a step of moving the transducer 2 and / or the coupling membrane 101 by means of the robotic arm 9, so as to reposition the focus 6 of the beam 3.

[0145] According to an embodiment, the method comprises a step of emptying the coupling liquid 107 from the coupling membrane 101 , by means of the emptying system 112, at the end of the therapeutic treatment or at an emergency condition.

[0146] Advantageously, by means of a coupling system 100 and a method as previously described, the risk of losing the coupling between the transducer 2 and the patient's skin 5 is minimized. Moreover, different organs and therapeutic targets 7 can be treated by the same transducer 2. Specifically, as previously described, the bending and deformations allowed by the coupling membrane 101 allow approaching or distancing or in any case modifying the positioning of the transducer 2 with respect to the patient's skin 5, while maintaining the adhesion and connection between the transducer 2 and the patient's skin 5, and thus allow using the same transducer 2 for therapeutic targets 7 localized at different depths. Moreover, a coupling system 100 and a method as previously described allow obtaining the certainty that no air is present between the patient’s skin 5 and the transducer 2, as long as the adhesion crown 103 adheres to the patient’s skin 5 and the adhesion crown 103 implements a suction on the patient’s skin 5. With further advantage, since the coupling membrane 101 , and in particular the adhesion crown 103, are not crossed by the passage of the focused ultrasound beam 3, they can be made of different materials, and therefore do not require the use of special materials.

[0147] Ultrasound system

[0148] The robot 1 comprises a focused ultrasound transducer 2.

[0149] The transducer 2 is configured to emit a focused ultrasound beam 3, along an emission direction 4.

[0150] In particular, the emission direction 4 can be directed towards a patient’s skin 5.

[0151] The beam 3 of focused ultrasound converges in a focus 6.

[0152] During the treatment, the focus 6 of the beam 3 is positionable at a therapeutic target 7, e.g., a tumor mass.

[0153] The robot 1 comprises an electronic processing unit 8, configured to control the operation of the robot 1.

[0154] According to an embodiment, the robot 1 comprises an ultrasound system 200.

[0155] The ultrasound system is configured to carry out an ultrasound of the patient. In particular, the ultrasound system is configured to carry out an ultrasound of the therapeutic target 7 and of a portion of the patient's body at the therapeutic target 7.

[0156] The ultrasound system 200 comprises an ultrasound probe 201. The ultrasound probe 201 is configured to carry out an ultrasound of the patient, in particular to carry out an ultrasound of the therapeutic target 7 and of a portion of the patient's body at the therapeutic target 7.

[0157] Specifically, the ultrasound probe 201 is configured to acquire images of the therapeutic target 7.

[0158] The ultrasound probe 201 is connected to the transducer 2. Specifically, the ultrasound probe 201 is connected to the transducer 2 so that it can be faced, together with the transducer 2, to the patient's skin 5.

[0159] Method 300 for tracking and compensating for the movement of a therapeutic target

[0160] According to an embodiment, the robot 1 is configured to carry out a method 300 for tracking a therapeutic target 7 and compensating for the movement of the therapeutic target 7.

[0161] According to an embodiment, the method 300 can be carried out by an ultrasound scanning system.

[0162] Such a tracking and compensation method 300 can be carried out by the robot 1 following the coupling of the robot 1 , and in particular the head body 12 of the robot 1 , to the patient's skin 5.

[0163] According to an embodiment, the coupling between the robot 1 , and in particular the head body 12 of the robot 1 , and the patient's skin 5 can be carried out by means of a coupling system 100 as previously described and by carrying out the method for coupling a focused ultrasound transducer 2 with the patient's skin 5, by means of the coupling system 100, as previously described and not repeated here to avoid redundancies.

[0164] Alternatively, such a tracking and compensation method 300 can be carried out following a step of coupling between the robot 1 , and in particular the head body 12 of the robot 1 , and the patient’s skin 5, in which the head body 12 comprises coupling mechanism 15 comprising a balloon 208 fillable with coupling liquid, preferably degassed water, configured to be pressable against the patient’s skin 5 to couple the transducer 2 to the patient’s skin 5.

[0165] According to an embodiment, the head body 12 comprises an ultrasound system 200 as previously described.

[0166] The tracking and compensation method 300 of the movement of a therapeutic target 7 comprises a step of identifying 304 a movement plane 301 of the therapeutic target 7.

[0167] The method 300 then comprises a step of aligning 305 the head body 12 to the identified movement plane 301.

[0168] The method 300 then comprises a step of tracking 306 the movement of the therapeutic target 7.

[0169] The method 300 then comprises a step of learning 307 of the movement of the therapeutic target 7.

[0170] The method 300 then comprises a step of planning 308 of a trajectory which can be travelled by the head body 12 to compensate for the movement of the therapeutic target 7 learned during the step of learning.

[0171] The method 300 then comprises a step of moving 309 the head body 12 along the planned trajectory, in order to compensate for the movement of the therapeutic target 7.

[0172] According to an embodiment, during the step of moving the head body 12 along the planned trajectory, the method 300 comprises a step of controlling the compensation consistency of the movement of the therapeutic target 7, in order to determine whether the compensation of the movement of the therapeutic target 7 is carried out correctly.

[0173] According to an embodiment, during the step of moving the head body 12 along the planned trajectory, the method 300 comprises a step of controlling the coupling between the head body 12 and the patient's skin 5, in order to verify that the head body 12 and the patient's skin 5 remain coupled while carrying out the method.

[0174] According to an embodiment, such a method 300 can be automated by the electronic control unit 8.

[0175] Advantageously, a tracking and compensation method 300 thus configured allows tracking and compensating for the movement of a therapeutic target 7 with high accuracy, with short execution times while minimizing the risk of losing the coupling between the robot 1 and the patient's skin 5.

[0176] According to an embodiment, the step of automatically identifying a movement plane 301 of the therapeutic target 7 is carried out by moving the head body 12, implementing a rotation of the head body 12 around an emission direction 4. According to an embodiment, such a step is carried out by implementing a rotation of the ultrasound probe 201 around the emission direction 4.

[0177] Thereby, it is possible to acquire and record, by the head body 12, and in particular by the ultrasound probe 201 , a plurality of two-dimensional ultrasound images, extended on a respective image plane 303, at different angles with respect to the emission direction 4. Such a plurality of image planes 303 is intersected with the emission direction 4, i.e., the emission direction 4 is coplanar with the image planes 303.

[0178] Where the therapeutic target 7 is moving, such a movement is, under physiological conditions, a linear motion in three-dimensional space. In other words, the movement of the therapeutic target 7 is identifiable to a movement along a movement line 302 in three-dimensional space. Since a line always lies in infinite planes, a movement plane of the target to be treated therefore exists. In particular, a plane exists, in which both the movement line 302, along which the therapeutic target 7 physiologically moves, and the direction of emission 7 lie. Such a plane is identified as the movement plane 301 of the therapeutic target 7. To be able to track the movement of the therapeutic target 7 and then compensate for it, it is necessary to identify such a movement plane 301 , in which the emission direction 4 and the movement line 302 along which the therapeutic target 7 physiologically moves are coplanar.

[0179] According to an embodiment, during the identification step, the method 300 comprises a step of verifying the coupling between the head body 12 and the patient’s skin 5, for example by means of sensors 114 as previously described, or by means of load cells or joint sensors of the robot 1.

[0180] According to an embodiment, the images acquired, for example by the ultrasound probe 201 , are processed by the electronic processing unit 8 to calculate a "movement index" of the therapeutic target 7 in the respective image plane 303. The movement index is a parameter which quantifies the movement of the therapeutic target 7 in the respective image plane 303. In accordance with this embodiment, the movement plane 301 is calculated and identified as the image plane 303 in which the calculated "movement index" parameter has the maximum value.

[0181] Following the step of identifying the movement plane 301 , the robot 1 aligns the head body 12, and therefore the transducer 2 and possibly the ultrasound probe 201 , to the movement plane 301. Thereby, the image plane 303 acquired by the ultrasound probe 201 coincides with the movement plane 301.

[0182] According to an alternative embodiment, the step of identifying the movement plane 301 and the alignment of the head body 12 to the identified alignment plane 301 is avoidable if the robot 1 is provided with a three-dimensional ultrasound probe.

[0183] According to an embodiment, the step of tracking the therapeutic target 7 comprises a step of recording, by the electronic processing unit 8, during a certain time interval, the images acquired by the robot 1 , preferably acquired by the ultrasound probe 201.

[0184] According to an embodiment, the electronic processing unit 8 is configured to automatically identify the therapeutic target 7 in the acquired images.

[0185] According to an embodiment, the robot 1 comprises a graphical interface in which the acquired images can be shown, and the therapeutic target 7 can be drawn by an operator on the graphical interface, so that the electronic processing unit 8 recognizes the therapeutic target 7.

[0186] According to an embodiment, the robot 1 comprises a tracking module configured to identify the moving therapeutic target 7, in the acquired images. Such an identification can be carried out by the tracking module, for example by means of a machine learning process.

[0187] According to an embodiment, the step of learning the previously tracked movement of the therapeutic target 7 comprises a step of estimating the trajectory of the therapeutic target 7 in space, in a certain time interval, in which the space is identified by spatial coordinates, for example spatial coordinates integral with the foot end 11 of the robot 1 .

[0188] According to an embodiment, the step of planning the trajectory which can be travelled by the head body 12 to compensate for the movement of the therapeutic target 7 learned during the learning step, comprises a step of calculating, by means of the electronic processing unit 8 and using the trajectory of the therapeutic target 7 previously estimated, a trajectory which allows always keeping the therapeutic target 7 in the focus 6 of the beam 3.

[0189] According to an embodiment, such a trajectory which can be travelled by the head body 12 can be a translation of the head body 12 along a direction transverse to the emission direction 4, or a rotation of the head body 12 around an axis transverse to the emission direction 4 and coplanar with the transducer 2.

[0190] According to an embodiment, the robot 1 is configured to use electronic steering, i.e., a variation of the focal distance of the focus 6, i.e., a variation of the distance between the focus 6 and the transducer 2, to carry out a compensation in the direction axial to the transducer 2, i.e., along the emission direction 4.

[0191] According to an embodiment, the step of moving the head body 12 along the planned trajectory can be carried out automatically, by means of the electronic processing unit 8 and the robotic arm 9.

[0192] According to an embodiment, the step of verifying the compensation consistency of the movement of the therapeutic target 7 comprises, during the movement of the head body 12 along the planned trajectory, sending the images acquired by the robot 1 , possibly by the ultrasound probe 201 , to the tracking module for verifying the quality of the compensation. Specifically, the electronic processing unit 8 estimates a compensation error, i.e. , a residual movement of the therapeutic target 7 with respect to the head body 12, and in particular with respect to the transducer 2. According to an embodiment, such an estimated compensation error is usable to correct the compensation trajectory which can be travelled by the head body 12 to compensate for the movement of the therapeutic target 7. Advantageously, such a configuration allows adjusting the compensation trajectory of the head body 12 by means of a closed-loop control.

[0193] According to an embodiment, the step of controlling the coupling between the head body 12 and the patient's skin 5, comprises verifying the correct acoustic coupling between the head body 12 and the patient's skin 5, by means of processing, by the electronic processing unit 8, data and parameters detected by the robot 1 and / or by the ultrasound system, such as the images acquired by the robot 1 , in particular by the ultrasound probe 201 , or interaction forces between the robot 1 and the patient's skin 5.

[0194] Advantageously, a method 300 thus configured avoids having to temporarily suppress the patient's breathing during the treatment. Moreover, a method thus configured allows an automatic recognition of the movement plane 301 of the therapeutic target 7. Moreover, a method thus configured increases the efficiency of the therapeutic treatment, by virtue of the accurate compensation made by the robot 1. Moreover, a method thus configured allows verifying the maintenance of the acoustic coupling between robot 1 and patient during the compensation by the robot 1 of the movement of the therapeutic target 7, in particular by means of a closed-loop control. Moreover, a method thus configured allows verifying the correct compensation of the movement of the therapeutic target 7, in particular by means of a closed-loop control. It is possible to carry out the previously described method 300 by means of a robot for medical or diagnostic or therapeutic treatments, having a head body, for applications other than focused ultrasound therapy, but which need to carry out the tracking and compensation of the movement of a therapeutic or diagnostic target.

[0195] Method 500 for intra-operatively planning a therapeutic treatment strategy and method 600 for implementing a planned therapeutic treatment strategy

[0196] According to an embodiment, the robot 1 is configured to carry out a method 500 for intra-operatively planning a therapeutic treatment strategy, in particular with focused ultrasound.

[0197] According to an embodiment, the method 500 can be carried out by the robot 1 following the coupling of the robot 1, and in particular the head body 12 of the robot 1, to the patient's skin 5.

[0198] According to an embodiment, the coupling between the robot 1 , and in particular the head body 12 of the robot 1, and the patient's skin 5 can be carried out by means of a coupling system 100 as previously described and by carrying out the method for coupling a focused ultrasound transducer 2 with the patient's skin 5, by means of the coupling system 100, as previously described and not repeated here to avoid redundancies.

[0199] Alternatively, such a method 500 can be carried out following a step of coupling between the robot 1, and in particular the head body 12 of the robot 1, and the patient’s skin 5, in which the head body 12 comprises a coupling mechanism 15 comprising a balloon 208 fillable with coupling liquid, preferably degassed water, configured to be pressable against the patient’s skin 5 to couple the transducer 2 to the patient’s skin 5.

[0200] According to an embodiment, the head body 12 comprises an ultrasound system as previously described.

[0201] According to an embodiment, the method 500 can be carried out by the robot 1 following having carried out a method for tracking and compensating for the movement of a therapeutic target 7. According to an embodiment, such a method for tracking and compensating for the movement of a therapeutic target 7 is carried out according to the method 300 as previously described and not repeated here to avoid redundancies.

[0202] The method 500 for intra-operatively planning a therapeutic treatment strategy comprises a step of three-dimensional scanning 503 of the therapeutic target 7.

[0203] The method 500 then comprises a step of three-dimensionally reconstructing 504 the therapeutic target 7.

[0204] The method 500 then comprises a step of planning an ablation strategy 505 of the therapeutic target 7.

[0205] According to an embodiment, the three-dimensional scanning step is followed by an automatic movement of the head body 12, preferably of the ultrasound probe 201, to scan a volume of the patient's body containing the therapeutic target 7, and a recording of the images acquired by the head body 12, preferably by the ultrasound probe 201.

[0206] According to an embodiment, said step of three-dimensionally scanning the therapeutic target 7 is carried out by means of the previously described ultrasound system.

[0207] According to an embodiment, said step of three-dimensionally scanning the therapeutic target 7 comprises a step of recording the images acquired by the ultrasound probe 201 and a step of recording the kinematics of the robotic arm 9.

[0208] According to an embodiment, the step of three-dimensional reconstruction comprises a step of segmenting the images acquired by the head body 12, preferably by the ultrasound probe 201 , and a subsequent 3D reconstruction of the therapeutic target 7.

[0209] According to an embodiment, the step of segmenting comprises a segmentation of the therapeutic target 7 in each image acquired by the head body 12, preferably by the ultrasound probe 201.

[0210] According to an embodiment, the subsequent step of 3D reconstruction is carried out based on the previous step of recording the kinematics of the robotic arm 9.

[0211] According to an embodiment, the steps of automatic segmentation and 3D reconstruction are carried out automatically by the electronic processing unit 8, by means of artificial intelligence algorithms. Advantageously, such a step allows verifying that the reconstruction of the therapeutic target 7 coincides with the diagnoses made in the preoperative step, possibly carried out by means of imaging devices, such as CT or MRI. Such a verification can be carried out by a human operator.

[0212] According to an embodiment, the step of planning an ablation strategy comprises a step of defining a cloud 501 of treatment foci 502 on the therapeutic target 7.

[0213] According to an embodiment, the cloud 501 is configured to minimize the total number of treatment foci 502, in which the focus 6 of the beam 3 can then be positioned to ablate the portion of therapeutic target 7 localized in the respective treatment focus 502. According to an embodiment, the cloud 501 is further configured to optimize the spatial distribution of the treatment foci 502. Advantageously, this allows respecting any anatomical constraints at the therapeutic target 7.

[0214] According to an embodiment, the step of planning an ablation strategy comprises, after the step of defining a cloud 501 of treatment foci 502, a step of defining an order of ablation of the treatment foci 502, and / or of defining sonication parameters of the treatment foci 502, and / or of defining treatment times. Advantageously, this allows planning an optimal treatment foci 502 ablation / sonication strategy, so as to minimize the treatment times and side effects. By way of example, a subsequent sonication of non- adjacent treatment foci 502 can be planned, so as not to excessively overheat a certainportion of the therapeutic target 7, but distribute the sonication over non-adjacent treatment foci 502 so as to simultaneously distribute the overheating over the entire therapeutic target 7. Conversely, again by way of example, a subsequent sonication of treatment foci 502 adjacent to each other can be planned, so as to reduce the movement times of the robotic arm 9 and thus reduce the times for carrying out the treatment.

[0215] According to an embodiment, the robot 1 is configured to carry out a method 600 for implementing a planned therapeutic treatment strategy.

[0216] The method 600 comprises a step of intra-operatively planning a therapeutic treatment strategy. Such a step of intra-operatively planning a therapeutic treatment strategy is carried out according to the method 500 previously described and not repeated here to avoid redundancies.

[0217] After carrying out the method 500, and in particular after the step of planning an ablation strategy of the therapeutic target 7, the method 600 comprises a step of implementing 601 the planned ablation strategy of the therapeutic target 7.

[0218] According to an embodiment, the step of implementing the planned ablation strategy comprises carrying out the one or more ablations / sonications of the identified treatment foci 502, by means of the focused ultrasound beam 3. Specifically, a plurality of ablations / sonications are carried out by aiming the focus 6 of the beam 3 in sequence on the respective previously identified treatment foci 502.

[0219] According to an embodiment, the step of implementing the planned ablation strategy comprises a step of compensating for the movement of the therapeutic target 7. According to an embodiment, said step of compensating for the movement of the therapeutic target 7 can be carried out according to the method 300 previously described and not repeated here to avoid redundancies.

[0220] According to an embodiment, the step of implementing the planned ablation strategy comprises a step of verifying the correct coupling between the head body 12 and the patient’s skin 5 and / or a step of verifying that the correct carrying out of the sonication process. According to an embodiment, in case of an incorrect coupling between the head body 12 and the patient's skin 5 and / or of an incorrect carrying out of the sonication process, the method includes a step of correcting the ablation strategy or an error report to an operator or an interruption of the method 600.

[0221] Advantageously, a method 500 for intra-operatively planning a therapeutic treatment strategy and a method 600 for implementing a planned therapeutic treatment strategy allow reducing the automatic segmentation times of the therapeutic target 7 and the optimized ablation times, increasing the accuracy and efficacy of the therapeutictreatment, allow a compensation of the movement of the therapeutic target 7, and increase the safety of the therapeutic treatment.

[0222] Method 700 for monitoring and correcting a therapeutic treatment online

[0223] According to an embodiment, the robot 1 is configured to carry out a method 700 for monitoring a therapeutic treatment online, in particular a focused ultrasound treatment, and for the possible correction and optimization of the monitored therapeutic treatment online.

[0224] According to an embodiment, the method 700 can be carried out by the robot 1 following the coupling of the robot 1 , and in particular the head body 12 of the robot 1 , to the patient’s skin 5.

[0225] According to an embodiment, the coupling between the robot 1 , and in particular the head body 12 of the robot 1 , and the patient's skin 5 can be carried out by means of a coupling system 100 as previously described and by carrying out the method for coupling a focused ultrasound transducer 2 with the patient's skin 5, by means of the coupling system 100, as previously described and not repeated here to avoid redundancies.

[0226] Alternatively, such a method 700 can be carried out following a step of coupling between the robot 1 , and in particular the head body 12 of the robot 1 , and the patient’s skin 5, in which the head body 12 comprises a coupling mechanism 15 comprising a balloon 208 fillable with coupling liquid, preferably degassed water, configured to be pressable against the patient’s skin 5 to couple the transducer 2 to the patient’s skin 5.

[0227] According to an embodiment, the head body 12 comprises an ultrasound system as previously described.

[0228] According to an embodiment, the method 700 can be carried out by the robot 1 following having carried out a method for tracking and compensating for the movement of a therapeutic target 7. According to an embodiment, such a method for tracking and compensating for the movement of a therapeutic target 7 is carried out according to the method 300 as previously described and not repeated here to avoid redundancies.

[0229] According to an embodiment, the method 700 can be carried out by the robot 1 during or after carrying out a method for intra-operatively planning a therapeutic treatment strategy.

[0230] According to an embodiment, the method 700 can be carried out by the robot 1 during a method for implementing a planned therapeutic treatment strategy.

[0231] According to an embodiment, said method for intra-operatively planning a therapeutic treatment strategy is carried out according to the method 500 as previously described and not repeated here to avoid redundancies.

[0232] According to an embodiment, such a method for implementing a planned therapeutic treatment strategy is carried out according to the method 600 as previously described and not repeated here to avoid redundancies.

[0233] According to an embodiment, the method 700 is carried out during a focused ultrasound therapeutic treatment involving carrying out a plurality of successive sonications, by means of the beam 3 converging in the focus 6, in which the focus 6 is then positioned at a plurality of portions of the therapeutic target 7, or treatment foci 502. Specifically, each sonication requires a respective position of the focus 6 in space, a certain application time of the beam 3, a certain power of the beam 3, a certain duty cycle. Therefore, the focused ultrasound therapeutic treatment is carried out point by point, in which for each treatment focus 502 to be treated, the therapeutic treatment method can include different treatment parameters, as previously described.

[0234] The method 700 for monitoring a therapeutic treatment online and for the possible correction and optimization of the monitored therapeutic treatment online, comprises a step of acquiring 701 , by means of a monitoring module, a plurality of data related to the execution of the therapeutic treatment carried out by means of a therapeutic module.

[0235] According to an embodiment, the monitoring module is an ultrasound probe system as previously described.

[0236] According to an embodiment, the therapeutic module comprises the abovedescribed transducer 2.

[0237] According to an embodiment, the step of acquiring a plurality of data comprises acquiring a plurality of data related to the carrying out the therapeutic treatment at each treated therapeutic target portion 7, or treated treatment focus 502. Specifically, the acquisition of the treatment data related to a certain treatment focus 502 occurs during the sonication of the same treatment focus 502.

[0238] According to an embodiment, one of the data obtainable from the monitoring module is an estimate of the temperature of the treated treatment focus 502. Therefore, during the sonication of the certain treatment focus 502, the monitoring module is configured to carry out a detection of an estimate of the temperature of the portion of the therapeutic target 7 corresponding to the treatment focus 502.

[0239] According to an embodiment, one of the data obtainable from the monitoring module is an estimate of the cavitation generated at the treated treatment focus 502. Therefore, during the sonication of the certain treatment focus 502, the monitoring module is configured to detect an estimate of the cavitation carried out in the therapeutic target portion 7 corresponding to the treatment focus 502.

[0240] According to an embodiment, the method 700 comprises a step of treatment map processing 702. According to an embodiment, the processing of the one or more treatment maps is carried out by the electronic processing unit 8 of the robot 1 , or by a processor outside the robot 1 .

[0241] According to an embodiment, the treatment map is a temperature estimation map of the treatment foci 502 of the therapeutic target 7, preferably already treated by the therapeutic module. Therefore, the map contains information related to the estimate of temperature of the portion of tissue corresponding to the treatment focus 502 treated by the therapeutic module.

[0242] According to an embodiment, the treatment map is a cavitation estimation map of the treatment foci 502 of the therapeutic target 7, preferably already treated by the therapeutic module. Therefore, the map contains information related to the estimate of cavitation generated in the portion of tissue corresponding to the treatment focus 502 treated by the therapeutic module.

[0243] According to an embodiment, the method 700 comprises a step of feedback 703. According to an embodiment, the step of feedback is carried out by the electronic processing unit 8 of the robot 1 , or by a processor outside the robot 1.

[0244] In the step of feedback, the one or more previously developed treatment maps are compared with one or more predefined reference maps.

[0245] Specifically, the predefined reference maps are developed before carrying out the therapeutic treatment. Preferably, the predefined reference maps are developed during the therapeutic treatment planning step.

[0246] Advantageously, by comparing the treatment maps with the predefined reference maps, it is possible to verify that the therapeutic treatment has been carried out correctly, i.e., in accordance with the planned treatment represented by the predefined reference maps.

[0247] According to an embodiment, a predefined reference map is a temperature map of the treatment foci 502 of the therapeutic target 7 which is planned to be reached following the sonication of the treatment foci 502 by the therapeutic module. Therefore, the map contains information related to the temperature of the portion of tissue corresponding to the treatment focus 502 which is intended to be achieved following the treatment by the therapeutic module.

[0248] According to an embodiment, the predefined reference map is a cavitation map of the treatment foci 502 of the therapeutic target 7 which is planned to be carried out following the sonication of the treatment foci 502, by the therapeutic module. Therefore,the map contains information related to the cavitation of the portion of tissue corresponding to the treatment focus 502 which is intended to be achieved following the treatment by the therapeutic module.

[0249] According to an embodiment, following the step of feedback, the method 700 can comprise a step of therapy updating. The step of therapy updating can be requested and carried out if a certain divergence between the one or more treatment maps and the one or more predefined reference maps is detected as a result of the step of feedback, for example if such a divergence highlights that the therapeutic effect achieved is considered insufficient.

[0250] According to an embodiment, the step of therapy updating comprises an update of the method 600 for intra-operatively planning a therapeutic treatment strategy. Advantageously, this allows carrying out the therapeutic treatment on the predetermined therapeutic targets 7 or treatment foci 502, and not carrying out the therapeutic treatment on tissues not included in the therapeutic targets 7 or treatment foci 502.

[0251] According to an embodiment, following the step of feedback, the method 700 can comprise a step of emergency 704. The step of emergency can comprise an interruption of the therapeutic treatment. The step of emergency can be requested if, following the step of feedback, a certain divergence is detected between the one or more treatment maps and the one or more predefined reference maps, for example if such a divergence highlights that the therapeutic effect achieved is considered too high, i.e., harmful or dangerous for the patient.

[0252] Advantageously, a method 700 thus configured allows mitigating any errors in the implementation of the therapeutic treatment with respect to the planned and predetermined treatment. With further advantage, the method 700 allows correcting the therapeutic treatment online, for example in the case of an underestimation error, i.e., a therapeutic effect assessed too low with respect to the planning. With further advantage, the method 700 allows implementing emergency or treatment interruption mechanisms, for example in the case of an overestimation error, i.e., a therapeutic effect assessed too high with respect to the planning. With further advantage, the method 700 thus configured allows carrying out a quantitative verification of the therapeutic effect produced, in particular by means of the treatment maps and the predefined reference maps developed.

[0253] Obviously, those skilled in the art will be able to make changes or adaptations to the present invention, without however departing from the scope of the following claims.REFERENCE NUMERALS1. Robot2. Transducer3. Focused ultrasound beam4. Emission direction5. Patient’s skin6. Focus7. Therapeutic target8. Electronic processing unit9. Robotic arm10. Robotic arm head end11. Robotic arm foot end12. Robot head body13. Transducer emission wall15. Coupling mechanism100. Coupling system101. Coupling membrane102. Fixing end103. Adhesion crown104. Coupling channel105. Pneumatic pumping system106. Hydraulic pumping system107. Coupling liquid108. Suction duct109. Hydraulic inlet duct110. Hydraulic outlet duct111. Cooling unit112. Emptying system113. Hydraulic emptying duct114. Coupling sensor115. Degassing unit116. Laparoscopic instrument200. Ultrasound system201. Ultrasound probe300. Method for tracking and compensating for the movement of a therapeutic target

Claims

CLAIMS1. A robot (1) for focused ultrasound therapeutic treatments, comprising a focused ultrasound transducer (2), configured to emit a focused ultrasound beam (3) along an emission direction (4), wherein the beam (3) converges in a focus (6), and wherein the robot (1) comprises an electronic processing unit (8) configured to control the operation of the robot (1), wherein the robot (1) comprises a coupling system (100) configured to make a coupling between the transducer (2) and the patient’s skin (5), wherein the coupling system (100) comprises a coupling membrane (101) fixable to the transducer (2) so as to extend along the emission direction (4) and not only, all around the beam (3) emanable by the transducer (2), wherein the coupling membrane (101) comprises an adhesion crown (103) configured to be connectable to the patient’s skin (5) and adhere to the patient’s skin (5), so that the coupling membrane (101) defines a coupling channel (104) extending between the transducer (2) and the adhesion crown (103), and wherein the transducer (2) is configured to emanate the beam (3) across the coupling channel (104), past the skin (5), and converge into the focus (6) at the therapeutic target (7), wherein the coupling membrane (101) comprises a fixing end (102), opposite to the adhesion crown (103) and fixed to the transducer (2), wherein the coupling system (100) further comprises a pneumatic pumping system (105) configured to generate a vacuum inside the adhesion crown (103), so that it adheres to the patient’s skin (5).

2. A robot (1) according to claim 1 , wherein the pneumatic pumping system (105) is configured to achieve a pneumatic vacuum inside the adhesion crown (103), and wherein, optionally, the pneumatic pumping system (105) is a compressor or a vacuum pump.

3. A robot (1) according to claim 1 or 2, wherein the pneumatic pumping system (105) comprises a suction duct (108) extending into the adhesion crown (103), in fluid connection with the adhesion crown (103), wherein the suction duct (108) is configured to suck air exiting from the adhesion crown (103), so as to generate a vacuum inside the adhesion crown (103), and wherein the suction duct (108) preferably extends along a direction substantially parallel to the emission direction (4), and preferably wherein a suction end of the suction duct (108) is positioned at the adhesion crown (103).

4. A robot (1) according to any one of the preceding claims, wherein the coupling membrane (101) is a flexible or deformable membrane, and preferably the coupling membrane (101) is an elastically deformable, extensible membrane.

5. A robot (1) according to any one of the preceding claims, comprising a hydraulic pumping system (106) configured to convey a coupling liquid (107) into the coupling channel (104) and at the outlet of the coupling channel (104), so as to fill the coupling membrane (101) with the coupling liquid (107) and modify the content of coupling liquid (107) inside the coupling membrane (101), so as to allow deformations of the coupling membrane (101), and wherein the coupling liquid (107) is a degassed liquid, preferably degassed water.

6. A robot (1) according to claim 5, wherein the transducer (2) and the hydraulic pumping system (106) are controllable by the electronic processing unit (8), so as to preserve the complete filling of the coupling membrane (101) with the coupling liquid (107), during any relative movements between the transducer (2) and the patient’s skin (5).

7. A robot (1) according to claim 5 or 6, wherein the hydraulic pumping system (106) comprises a hydraulic inlet duct (109) and a hydraulic outlet duct (110), wherein the hydraulic inlet duct (109) and the hydraulic outlet duct (110) extend into the coupling channel (104), in fluid connection with the coupling channel (104), wherein the hydraulic inlet duct (109) is configured to convey the coupling liquid (107) to enter in the coupling channel (104), so as to fill the coupling membrane (101) with the coupling liquid (107), wherein the hydraulic outlet duct (110) is configured to convey the coupling liquid (107) to exit from the coupling channel (104), wherein, optionally, the coupling system (101) comprises a cooling unit (111) fluidly connected to the hydraulic pumping system (106) and configured to receive the hot coupling liquid (107) from the coupling membrane (101), cool the coupling liquid (107), and convey the cold coupling liquid (107) towards the coupling membrane (101), wherein, optionally, the coupling system (101) comprises a degassing unit (115) fluidly connected to the hydraulic pumping system (106) and configured to receive the coupling liquid (107) from the coupling membrane (101), degas the coupling liquid (107), and convey the degassed coupling liquid (107) towards the coupling membrane (101),and wherein the hydraulic inlet duct (109) and the hydraulic outlet duct (110) extend into the coupling channel (104), wherein a conveying end of the hydraulic inlet duct (109) is positioned at the adhesion crown (103) and wherein a conveying end of the hydraulic outlet duct (110) is positioned at the fixing end (102) of the coupling membrane (101), or wherein the hydraulic inlet duct (109) and the hydraulic outlet duct (110) are the same duct, configured to convey the coupling liquid (107) entering in or exiting from the coupling channel (104).

8. A robot (1) according to any one of the preceding claims, comprising an emptying system (112), wherein the emptying system (112) comprises a hydraulic emptying duct (113) fluidly connected to the coupling channel (104), and wherein the emptying system (112) is configured to empty the coupling membrane (101) of the coupling liquid (107) contained in the coupling channel (104), and wherein, optionally, a suction end of the hydraulic emptying duct (113) is positioned at the adhesion crown (103).

9. A robot (1) according to any one of the preceding claims, comprising at least one coupling sensor (114) configured to detect and monitor at least one or more of the following physical parameters related to the coupling system (100):- the air pressure possibly present inside the adhesion crown (103),- the pressure of the coupling liquid (107) inside the coupling channel (104),- the temperature of the coupling liquid (107) inside the coupling channel (104),- the presence of dissolved gaseous substances inside the coupling liquid (107),- the deformation or bending of the coupling membrane (101), and wherein the at least one coupling sensor (114) is connected to the coupling membrane (101).

10. A method for coupling a focused ultrasound transducer (2) to a patient’s skin (5) by means of a coupling system (100), comprising the following steps:- positioning the transducer (2) at the patient’s skin (5),- fixing a coupling membrane (101) to the transducer (2),- positioning an adhesion crown (103) of the coupling membrane (101) on the patient’s skin (5),- generating a vacuum, preferably a pneumatic vacuum, inside the adhesion crown (103), by means of a pneumatic pumping system (105),and optionally a subsequent step of:- filling the coupling membrane (101) with coupling liquid (107), preferably degassed water, by means of a hydraulic pumping system (106), and optionally a step of:- detecting and monitoring one or more physical parameters related to the coupling system (100), by means of one or more coupling sensors (114), and / or a step of:- adjusting the coupling between the transducer (2) and the patient’s skin (5), by means of an electronic processing unit (8).

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