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EP-4739247-A1 - ROBOT FOR FOCUSED ULTRASOUND THERAPEUTIC TREATMENTS

EP4739247A1EP 4739247 A1EP4739247 A1EP 4739247A1EP-4739247-A1

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).

Inventors

  • MARIANI, ANDREA
  • MORCHI, Laura
  • CAFARELLI, Andrea
  • TOGNARELLI, SELENE
  • MENCIASSI, ARIANNA

Assignees

  • Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna

Dates

Publication Date
20260513
Application Date
20240626

Claims (10)

  1. 1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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).

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 c