Apparatus and method for preparing a patient for high intensity focused ultrasound treatment

Abstract

An apparatus (1) and method for preparing a patient (P) for treatment with high intensity focused ultrasound (HIFU), wherein the apparatus (1) is implemented to acquire images simultaneously with movement of an imaging device (4) along a longitudinal axis (8a, 8b).

Description

[0001] This application is a divisional application of the application with application number 2020800572998, application date June 17, 2020, entitled "Apparatus and method for preparing to treat a patient with high intensity focused ultrasound". Technical Field

[0002] The present invention relates to an apparatus for treating patients with high-intensity focused ultrasound (HIFU), particularly according to the independent claims, and a method for preparing such treatment. Background Technology

[0003] HIFU treatments can perform non-invasive ablation of anatomical targets within the body. They are typically guided by imaging modalities such as ultrasound, especially B-mode imaging.

[0004] In some devices, an ultrasound imaging transducer is embedded in a treatment head, which also includes, for example, a treatment transducer described in WO2006 / 129045.

[0005] Depending on the clinical indications and treatment plan, the target tissue may be difficult to visualize, which can complicate alignment. For example, if tumescent anesthesia is used when treating varicose veins under ultrasound (US) guidance, the fluid can compress the vein, making it difficult to distinguish from the surrounding tissue. In particular, the target may be almost invisible in certain 2D planes. Summary of the Invention

[0006] Therefore, the object of the present invention is to overcome the shortcomings of the prior art, and in particular to provide an apparatus and method that facilitates the alignment of a structure to be processed. In particular, the apparatus and method can be used to align a collapsed structure by ultrasound (US).

[0007] This objective, as well as other objectives, are achieved by the apparatus and method according to the independent claims of the invention.

[0008] The device for treating a patient via HIFU according to the present invention comprises a treatment head having a unit for emitting HIFU pulses and an imaging device having a probe, preferably an imaging device capable of performing mode B imaging. The imaging probe of the imaging device is preferably disposed within the treatment head. The device further comprises a control unit for controlling the movement of the probe. The control unit is adapted to implement the movement of the probe about a target during operation of the imaging device.

[0009] The probe can be moved by moving the treatment head, or it can be moved by moving the probe separately about the treatment head.

[0010] This invention allows for a method to estimate the location of a target based on information collected in a visible location.

[0011] When using a handheld probe to locate objects that are barely visible in B-mode imaging, a physician’s natural posture involves moving the probe back and forth orthogonally to the imaging plane.

[0012] In particular, this applies to cases of venous collapse in a transverse view: the physician moves the probe back and forth along the longitudinal axis of the vein. This movement enables (1) the differentiation of tubular structures from generally circular local heterogeneity, and (2) attentive close monitoring of the path of the tubular structure from a visible plane to a less clearly visible or invisible plane. This invention allows for improved alignment in HIFU treatment by means of robotic movement of the probe, which adopts a natural posture similar to that used in B-mode imaging.

[0013] In a preferred embodiment, the control unit is adapted to allow controllable movement of the user and / or to perform movement of the probe that substantially follows one of the following axes:

[0014] - An axis orthogonal to the current imaging plane;

[0015] - An axis parallel to the target's main axis;

[0016] - The projection of the main target axis onto a plane orthogonal to the main ultrasonic propagation axis;

[0017] - The projection of the main target axis onto a plane parallel to the skin surface.

[0018] Typically, this device is designed so that only one user action is required to perform the movements described above. For example, the movement can be triggered by a button (or other triggers described herein). The movement can then be performed automatically and can be any movement described herein. Particularly preferably, the treatment head stops for 0.5 seconds before returning to its initial position.

[0019] Alternatively or additionally, the device may allow and / or require multiple user actions. For example, the device may require a first trigger to move the treatment head away from a first position and a second trigger to move it back to the initial position. The movement may also include a pause, either automatically stopped by the device or triggered by the user.

[0020] This device is adapted to prevent the control from delivering any treatment pulses during treatment head movement. At least one image can be acquired during movement.

[0021] Typically, the movement can last for less than 20 seconds, preferably less than 10 seconds, and especially preferably less than 5 seconds.

[0022] Particularly preferably, the control is adapted to maintain acoustic coupling, for example, by maintaining a constant force applied to the tissue via the treatment head, while performing motion. This is especially advantageous if the motion follows a trajectory along the longitudinal axis of the target.

[0023] Therefore, the device, especially the treatment head, may include a force sensor.

[0024] Additionally or alternatively, acoustic coupling is maintained by employing a balloon filled with fluid and connected to a fluid circulation system capable of varying the volume of fluid within the balloon (as known in the prior art). Preferably, the fluid pressure within the balloon is monitored. This pressure remains substantially constant during movement to automatically adapt to the anatomical structure.

[0025] Preferably, the pressure is not kept constant during movement, but decreases while maintaining acoustic coupling as the movement moves away from the target, so as to allow enhanced target visibility when the target is reached at its furthest position.

[0026] For example, a probe can be embedded in a treatment head, and components of the device holding the treatment head can be switched to a mode where the current position (including translation and rotation) is denoted as the base position. Manual displacement of the treatment head, optionally restricted to some degrees of freedom, can be performed away from this base position, but when the treatment head is released, at least one component of that position automatically returns to the same value as the base position. This can be achieved, for example, by using a spring effect across all coordinates. Preferably, the device prevents pulses from being triggered when the treatment head is not in its base position.

[0027] Preferably, the control unit restricts the movement to displacement along one of the aforementioned axes.

[0028] Specifically, the control unit can be adjusted such that at least one type of motion that almost follows one of the aforementioned axes can be triggered by the HIFU user.

[0029] In a preferred embodiment, the control unit is adapted to store at least one reference position in a memory. The control unit is then further adapted to trigger movement of the probe to the reference position.

[0030] In another preferred embodiment, the control unit is adapted to allow probe movement, particularly user-controlled movement, only when there are no pulses, such as HIFU treatment pulses. Specifically, the control unit may allow probe movement between pulses.

[0031] Preferably, the treatment head can move along a preset trajectory during the pulse to properly distribute energy. Alternatively or additionally, an automated algorithm can be responsible for adjusting the trajectory based on real-time temperature feedback or for tracking the target based on automated image processing. In particular, if the device is adapted to allow controllable movement of the user only when no pulse is being emitted, such automated movement can still be performed even during pulse emission.

[0032] In a preferred embodiment, the control unit is adapted to move the probe away from the initial position at a first speed, and then preferably return to the initial position at a slower second speed.

[0033] The movement can be triggered automatically or manually by the user. In a preferred embodiment, the device includes a user interface to trigger the probe to move away from its current position.

[0034] In a particularly preferred embodiment, the user interface includes at least one actuator, such as a monostable button, to trigger movement of the probe away from its current position, wherein the control is preferably adapted to trigger movement of the probe back to its initial position or a saved reference position when the user releases the button.

[0035] Preferably, the movement of the probe, especially the movement back to the probe's initial position after the initial movement, occurs at a speed (e.g., <20 mm / s) that allows the user to visually follow the target on the image.

[0036] Alternatively, a button can be used, where manually pressing the button triggers movement toward a reference position. While reference buttons are explained in these respects, it should be understood that actuation can be performed using any type of actuator, such as a software-based actuator.

[0037] Alternatively, there could be a control that allows the probe to remain in place when the user releases the button. Preferably, the user can then place a marker on the imaging device's screen to indicate the location of a vein or any other structure. The return motion can then be triggered by pressing the same or another button or actuator.

[0038] More precisely, at least one actuator can be used to trigger movement of the probe approximately along one of the aforementioned axes away from its current position, and in particular, towards the reference position. When the user releases the button, the probe returns to its initial position, specifically to the reference position.

[0039] Generally speaking, a reference location refers to the location where treatment will be performed, i.e., the location where at least one HIFU pulse is planned to be delivered.

[0040] Alternatively, the motion to return to the reference position can be performed automatically.

[0041] Additionally or alternatively, the reference position can also be corrected, meaning that movement can leave the reference position and return to the corrected reference position.

[0042] If movement away from the reference position indicates displacement of the target tissue, such as a vein, from the reference position, then correcting the reference position can be particularly advantageous. In such cases, the reference position can be corrected by a determined displacement to treat the target tissue.

[0043] Therefore, the corrected reference position can preferably refer to a position in the same imaging plane as the reference position, but with a lateral and / or vertical displacement of the focal point in the plane and / or the plane perpendicular to the direction of motion.

[0044] Preferably, the movement is performed away from the reference position to a position that has not yet been fully treated, especially a position that has not been treated at all.

[0045] In another preferred embodiment, the user interface includes two buttons to trigger movement of the probe, preferably each button for a direction along a selected axis. These buttons can be physical, such as a foot switch, or virtual, such as a touchscreen. Preferably, at least one button is selected from the group consisting of physical or virtual buttons.

[0046] In a preferred embodiment, the user interface includes drag-and-drop controls on the screen. Specifically, the drag-and-drop should include a mechanism where, when a trigger is actuated, such as by clicking a virtual button or entry, the movement of the head is controlled by the user. When the trigger is released, the movement stops.

[0047] In a preferred embodiment, the control unit is adapted to perform the vibrational movement of the probe almost along one of the aforementioned axes.

[0048] Preferably, the control unit is adapted for implementation.

[0049] - One or a preset number of vibrations around the initial position. It is also suitable for performing a limited number of damped vibrations around the current position. Damped vibrations may include, in particular, vibrations with decreasing amplitude over time. Continuous vibrations may also be performed around the initial position until a preset criterion is met, especially until the release button is pressed.

[0050] Specifically, a physical or virtual button is used to trigger the probe's vibration movement roughly along one of the aforementioned axes. Possible vibration movements include, but are not limited to:

[0051] -For example, one or a predetermined number of vibrations around the current position at a sinusoidal speed.

[0052] - A finite number of damped vibrations around the current position, such as damped sinusoidal velocities.

[0053] - Continuous vibration around the current position until the button is released.

[0054] In a preferred embodiment, the control unit is adapted to perform vibrational movements with an amplitude greater than 1 millimeter (mm), preferably greater than 1 centimeter (cm). The amplitude may be fixed or adjustable by the user.

[0055] In another preferred embodiment, the control unit is adapted to perform motion along a trajectory that is at least partially curved.

[0056] In a particularly preferred embodiment, the device is further designed to move not along a straight line, but along a trajectory defined by the user (e.g., drawn on a touchscreen) or automatically calculated based on anatomical knowledge. For example, if the location of the target vein is known in several orthogonal planes, interpolation of these locations can define the trajectory along which the probe moves.

[0057] In a preferred embodiment, the device includes at least one of an input interface for user-defined trajectories and a calculation unit for automatically calculating trajectories, preferably based on knowledge of anatomical structures.

[0058] In a preferred embodiment, the control unit is adapted to perform motion at an average displacement speed ranging from 0.1 mm / s to 100 mm / s, preferably from 0.5 to 30 mm / s.

[0059] Specifically, the movement speed is not necessarily constant with time and / or along the trajectory. Preferably, the speed is adapted to be compatible with the image acquisition time, so that the spatial interval between two images is small compared to the desired accuracy. For example, if the embedded hardware requires 50 milliseconds (ms) to acquire images and the spatial step size between two images should be less than 0.25 mm, then the shift speed should be less than 5 mm / s.

[0060] In alternative embodiments, the control unit is adapted to perform movement via controls representing the coordinates of the probe, particularly along an axis substantially orthogonal to the imaging plane. For example, the controls may include electronic and / or mechanical controls, such as joysticks, or purely virtual controls on a screen or user interface. Alternatively or additionally, the controls may include a representation of an accessible range along the axis and are adapted to allow a user to click a location to move the treatment head to that location. Preferably, at least one reference location is defined, and when the user clicks near this reference location, the control unit moves the treatment head to said reference location. The reference location may, in particular, be a location where HIFU pulses are planned to be delivered. For example, a set of discrete reference locations may lie on an axis orthogonal to the imaging plane. When the user clicks a location on this axis, the software calculates the nearest reference location from this set of discrete locations and moves the treatment head to that location. This allows the treatment head to be moved from its current position to visualize the vein and returned to one of the reference locations to deliver pulses at controlled intervals. The probe and / or treatment head may perform actions selected from the group of treatment steps, HIFU emission, and imaging steps after movement away from the vein and / or before movement back to one of the reference locations.

[0061] In another preferred embodiment, movement is commanded by a control representing the coordinates of the probe, allowing the user to control the movement, for example, by dragging and dropping gestures as if holding the probe in hand. Preferably, the control restricts the movement to displacement along one of the aforementioned axes.

[0062] Preferably, in embodiments where the return to the position where the next pulse will be delivered is not automatically triggered, the user can perform some actions before triggering the return to the position where the next pulse will be delivered. These actions include, but are not limited to, changing some characteristics of the real-time image (e.g., switching from B-mode to dual imaging) and / or moving the probe and / or treatment head. For example, this can be done with the imaging probe embedded in the treatment head and the user controlling the position of the probe along an axis that substantially corresponds to the longitudinal axis of the vein. Once in a position where the vein is visible to the user, the user can move the treatment head to focus the HIFU on the target (e.g., using dedicated controls). He can then rotate the treatment head along the main ultrasound propagation axis to refine the longitudinal view of the target, which serves to define the new displacement axis as the axis of a longitudinal plane orthogonal to the main ultrasound propagation axis. Movement along this new axis is then triggered to the position where ultrasound treatment should be performed. At this position, the focus is approximately on the target, requiring little or no position adjustment.

[0063] In a preferred embodiment, the device includes a travel limiter for limiting the movement of the probe, particularly for limiting the spatial and / or coordinate range accessible to the probe.

[0064] In a particularly preferred embodiment, the travel limiter is determined by the mechanical limitation of the holding device for holding the probe or can be defined via a user interface, preferably by moving the holding device for holding the probe to the extreme point of image acquisition.

[0065] A balloon can be provided for the treatment head, including an imaging probe, defining a cavity for receiving coupling fluid. Most preferably, a pressure feedback loop ensures proper alignment with the anatomical structures. In particular, this should maintain acoustic coupling throughout the movement.

[0066] In a preferred embodiment, a control is used to move the probe in real time.

[0067] In an alternative preferred embodiment, which will be described in more detail below, the probe does not move during observation, but rather the movement of the probe is virtually simulated by navigation using controls within a set of images pre-acquired with the moving probe.

[0068] The device can be adapted to correlate collected images with coordinates along a trajectory and includes a display adapted to display images corresponding to given coordinates.

[0069] In a preferred embodiment, the control unit is also adapted to synchronize probe movement and image acquisition with the location of the layer from which HIFU pulses will be delivered, so as to acquire images at these locations.

[0070] Therefore, if the location of the layer to which the HIFU pulse will be delivered is known before acquisition, probe movement and image acquisition are preferably synchronized to acquire images at these locations.

[0071] Therefore, the collected images are preferably associated with coordinates along the trajectory, and the interface allows the display of the image corresponding to the given coordinates. Preferably, acquisition can be triggered at any time during treatment.

[0072] The device may also include navigation controls, preferably physical or virtual, for navigating within a group of acquired images. Most preferably, the user interface is capable of placing at least one marker on the image of the group of acquired images. Even more preferably, the marker is also displayed on live and / or frozen images. The virtual navigation control may be, for example, a slider on the user interface or any other control previously used in the context of describing the actual movement of the probe.

[0073] Specifically, if two images are not acquired at the same precise location, the markers can be appropriately shifted. For example, after acquisition, the user may have moved the treatment head or probe to place the focus deeper to align with the intended location of the vein. In this case, the live images are acquired in a reference frame that has been shifted compared to the set of acquired images. Therefore, when the acquired images are displayed, they are preferably shifted to align with the live images.

[0074] In an alternative embodiment, any robotic movement performed results in a corresponding shift in the displayed set of acquired images, so that the centers of the two views correspond to the same location within the anatomical structure. This may require cropping the images displayed in the set of acquired images.

[0075] In another particularly preferred embodiment, the display includes a first dedicated area for displaying acquired images and navigation, and a second dedicated area for displaying images of areas requiring ultrasound processing. Preferably, the layers displayed in real-time imaging can be marked on the controls. The display of acquired images and navigation is performed in a dedicated section of the interface, while real-time or frozen images of the areas requiring ultrasound processing are displayed in "Real-time Imaging".

[0076] In yet another particularly preferred embodiment, the display includes a shared area for displaying the acquired images and for displaying images of the area requiring ultrasound processing. When the virtual position of the probe is set to the actual position of the probe, a real-time image of the area requiring ultrasound processing is displayed. However, when the virtual position of the probe is set to another position, a corresponding image from a group of acquired images is displayed.

[0077] In a preferred embodiment, the navigation control is monostable, such that when it is released, the virtual position of the probe returns to the actual position of the probe. The motion back to the actual position of the probe is preferably performed at a low speed that can be visually tracked by the user, particularly corresponding to less than 20 mm / s in actual space.

[0078] In alternative embodiments, the control unit is adapted to perform movement via controls representing the coordinates of the probe, particularly along an axis substantially orthogonal to the imaging plane. For example, the controls may include electronic and / or mechanical controls, such as joysticks, or may be purely virtual controls on a screen or user interface. Alternatively or additionally, the controls may include a display of an accessible range along the axis and be adapted to allow the user to click a location to move the treatment head to that location. Preferably, at least one reference location is defined, near which the control unit moves the treatment head. The reference location may, in particular, be a location where HIFU pulses are planned to be delivered. For example, a set of discrete reference locations may lie on an axis orthogonal to the imaging plane. When the user clicks a location on this axis, the software calculates the nearest reference location from the discrete set of locations and moves the treatment head to that location. This allows the treatment head to be moved away from its current position to visualize the vein and back to one of the reference locations to deliver pulses with controlled intervals. The probe and / or treatment head may perform actions selected from the group of treatment steps, HIFU emission, and imaging steps after movement away from the vein and / or before movement back to one of the reference locations.

[0079] Preferably, the control unit is adapted to store at least two positions of the treatment head. Specifically, the positions should include the Cartesian coordinates and orientation of the treatment head.

[0080] In this disclosure, the features are described as easy to align. However, those skilled in the art will recognize that they can also be used to estimate the location of sensitive structures (e.g., nerves) that may be difficult to see.

[0081] The present invention also relates to a method for preparing to treat a patient using HIFU. Preferably, the method is performed using the apparatus disclosed herein. Treatment should be understood as delivering at least one HIFU pulse.

[0082] The method for preparing to treat a patient using HIFU according to the present invention includes the step of moving the treatment head away from the target site. At least one image is acquired at the site away from the target site. Based on the acquired at least one image, a target near the target site is defined. The treatment is then moved back to the target site. Optionally, HIFU pulses may be emitted at the target site.

[0083] The target area should be understood as the location where the treatment head is intended to treat. In particular, it should include both the spatial location and the orientation of the treatment head.

[0084] For example, the treatment head can be positioned at the target site of the vein to be treated. However, due to low visibility, the user cannot identify the vein on the ultrasound image. Therefore, the treatment head is moved to a different location where the vein is visible. Based on the vein's position and anatomical structure on the image, the user can infer the vein's position relative to the target site. Therefore, when the treatment head is moved back, HIFU pulses can be delivered more precisely.

[0085] In particular, tags can be used to label targets based on acquired images.

[0086] Preferably, the movement away from the target area includes at least one of the following: translational movement along the main ultrasound propagation axis, translational movement along an axis perpendicular to the main ultrasound propagation axis, and rotational movement about an axis passing through the focal point.

[0087] Rotational motion should be understood as the movement of the treatment head, in which the focal point remains in the same position within the patient's anatomy. Specifically, the treatment head rotates about an axis intersecting the focal point, such that the treatment head points towards the focal point throughout the entire movement.

[0088] Preferably, the rotational motion is performed about an axis parallel to the longitudinal axis of the target. Alternatively or additionally, the translational motion is performed along an axis parallel to the longitudinal axis of the target.

[0089] Preferably, at least one movement of the treatment head is performed automatically. For example, movements away from the target area can be performed manually by the user, and the device automatically saves the initial position and returns to that position. Alternatively or additionally, movements away from the target area can also be performed automatically.

[0090] Alternative methods include the step of acquiring a set of two-dimensional images before or during treatment, i.e., between pulses. Image acquisition includes the steps of positioning the treatment head on the patient, defining a longitudinal direction, and performing automated controlled motion along the longitudinal axis to acquire a set of images preferably orthogonal to the longitudinal axis, wherein the longitudinal direction preferably corresponds to the principal axis of the target or to the projection of that principal axis onto a plane orthogonal to the principal ultrasound propagation axis or parallel to the skin.

[0091] In a preferred embodiment, the treatment head, including an imaging probe, is used to acquire a set of 2D images before or during treatment, i.e., between the emission of treatment pulses.

[0092] In a preferred embodiment, the movement of the probe includes rotation along an axis preferably orthogonal to the main ultrasonic propagation axis. This rotation may or may not be combined with translation of the probe.

[0093] In a preferred embodiment, the probe is disposed within the treatment head and the control unit is adapted to hold the treatment head in the same position to keep the focus of the HIFU transducer in the same position while allowing the treatment head to rotate.

[0094] In another preferred embodiment, when the user releases the treatment head, it does not return to its initial rotational or axial position, but instead stores the new rotational coordinates of the treatment head as a visible angle.

[0095] In particular, axial or rotational position should be understood as the value of at least one coordinate. For example, a position can be fully characterized by its coordinates along three axes (x, y, z) and its rotation angle along three axes (psi(ψ), theta(θ), phi(φ)). A reference position containing the complete set of coordinates can certainly be stored, such as (x0, y0, z0, ψ0, θ0, φ0). Therefore, the probe can move from the current position (xl, yl, zl, psil, thetal, phil) to the position (x0, y0, z0, ψ0, θ0, φ0). If movement has already been triggered from another position (x2, y2, z2, ψ2, θ2, φ2), the treatment head will also have moved to (x0, y0, z0, ψ0, θ0, φ0).

[0096] However, it is also possible and should be included in the meaning of the reference position in this article as a subset of coordinates. For example, the reference position may only include angles such as (ψ0). If the treatment head is located at (xl, yl, zl, ψl, θl, φl) and a movement back to the reference position is triggered, the movement results in (xl, yl, zl, ψ0, θl, φl). If the movement is from another position (x2, y2, z2, ψ2, θ2, φ2), it will reach (x2, y2, z2, ψ0, θ2, φ2).

[0097] Alternatively, during rotation, the focus is not held in the same position, but rather along the axis or within a plane, to also allow translation of the treatment head. In a preferred embodiment, this is combined with the spring effect described above. For example, the user can set the device to a mode that allows free rotation about an axis passing through the focus and ii) allows the treatment head to move along an axis substantially parallel to the longitudinal axis of the vein due to the spring effect. When the user releases the treatment head, the rotational orientation does not change, but the treatment returns to its initial position along the allowed displacement axis.

[0098] In another preferred embodiment, the focus can be automatically or manually translated within the current imaging plane where the target is visible to accurately position the focus for pulse delivery to the target. Furthermore, pulse delivery is possible. For example, if alignment is based on B-mode imaging, when the probe is not orthogonal to the vein wall, the ultrasound beam generated by the imaging probe and reflected by the vein wall is reflected away from the probe. Therefore, only a small signal is detected, and the vein wall is barely visible. Conversely, if the probe is orthogonal to the vein wall, the imaging beam is reflected back to the imaging probe and the signal is good, thus the vein is visible. Therefore, for example, if the user can barely see the vein, the user can adjust the device to allow the treatment head to rotate to find a suitable viewing angle. This angle then corresponds to a near-optimal position for pulse delivery because the energy transfer is high, as the skin is substantially orthogonal to the main HIFU propagation axis.

[0099] Alternatively, another set of rotational coordinates is stored to define the treatment angle, in which at least one pulse is transmitted. For example, the user roughly positions the treatment head so that the focus is roughly on the target. The user then sets the device to allow rotation of the treatment head to an angle where he can easily see the vein. This position is stored as the observation angle. For example, if duplexing is used for alignment, this might correspond to a situation where the main propagation axis of the imaging beam is not orthogonal to the vein, in order to obtain some Doppler information. The user then moves the focus to properly align the vein. The user then sets the device to allow rotation of the treatment head again to the treatment angle, for example, making the main HIFU propagation axis orthogonal to the skin. The corresponding rotational coordinates are stored, and the user emits a pulse.

[0100] In a preferred embodiment, the user can trigger automatic movement when needed to position the treatment head at a visible or treatment angle. The user can also redefine these angles if required.

[0101] Please note that the center of rotation is not necessarily the axis around the focal point, but can be around another axis. For example, if the focal point must be 1 mm deeper than the vein, the center of rotation can be 1 mm above the focal point. Attached Figure Description

[0102] The invention will be described in detail below with reference to the following figures, which are shown in the figures:

[0103] Figure 1 : A schematic diagram of the device according to the present invention.

[0104] Figure 2 : A schematic diagram of the method performed by the present invention.

[0105] Figure 3 A set of display examples of acquired images and real-time imaging.

[0106] Figure 4Example of a user interface.

[0107] Figure 5 : Schematic diagram of rotational motion.

[0108] Figure 6 : A schematic diagram of a user interface with a saved reference location.

[0109] Figures 7a-7d : A schematic movement away from the reference position and back to the corrected reference position. Detailed Implementation

[0110] Figure 1 A device 1 for treating a patient with high-intensity focused ultrasound according to the present invention is schematically shown. The device 1 includes a treatment head 2 having a unit, in the form of a transducer 3, for emitting high-intensity focused ultrasound pulses. The transducer 3 is adapted to deliver the focused ultrasound pulses to a target T located within an object O. In this embodiment, the treatment head 2 also includes an imaging device 4. The treatment head also includes a balloon 5 for receiving fluid for acoustic coupling. The device also includes a moving device 6 connected to the treatment head 2 via an arm 7 and adapted to move the treatment head 2 along longitudinal axes 8a, 8b. Specifically, the moving device can be controlled to perform dynamic movements, such as vibration or movement, at varying speeds. In this embodiment, the moving device 6 also includes mechanical travel limiters 9a, 9b. These travel limiters can also be implemented as electronic or software-based limiters that restrict the accessibility of the treatment head to prevent damage to the patient or the device. The device also includes a control unit 10, which in this example is operatively connected to the transducer 2 and the moving device 6 by means of a cable 11.

[0111] Figure 2The diagram schematically illustrates how the method according to the invention works. A treatment head 2, including a balloon 5, is used to treat a target within an object O. Here, the method is performed prior to treating the patient. However, the same method may also be performed during treatment. First, a longitudinal axis 8a is defined. This longitudinal axis corresponds to the main propagation direction of the high-intensity focused ultrasound pulse; however, another axis, for example orthogonal to the main ultrasound propagation axis 8b, may also be chosen. Using a moving device (not shown) operably connected to the treatment head via an arm 7, the treatment head 2 moves along the longitudinal axes 8a and 8b while simultaneously operating an imaging device (not shown) integrated within the treatment head. This imaging device records multiple images 12a, 12b, 12c, 12d, and 12e corresponding to different points along the longitudinal axes 8a and 8b at different locations. Here, the target within the object O is visible only in some of the collected images. In images 12b and 12d, the target T is visible as represented by 13c and 13a. In image 12c, the target T is only partially visible as 13b. The collected images can then be acquired by the operator and used to locate the target. Alternatively, if the target T becomes invisible in the ultrasound image, the same image can be acquired during treatment.

[0112] Figure 3 An example of a user interface 39 with a set of acquired images 31 is shown. The user intends to perform ultrasound processing in a layer displayed in real-time imaging 34. In this layer, it is difficult to determine the exact location of the vein indicated by arrow 33. Therefore, the user scrolls through the spatial image loop 1 using slider 32 to an adjacent location where the vein can be clearly seen. Finally, when scrolling back to the layer where ultrasound processing will be performed, the user focuses intently on the vein.

[0113] Figure 4 An illustration of a possible user interface 39 is shown. In this example, the treatment head has already undergone lateral movement after acquisition. As a result, the images in the set of acquired images 31 have been displaced, forming a yellow area 40 where no information can be displayed. In this example, button 36 allows marker 35 to be placed onto the image of the set of acquired images 1. Since the two images are spatially aligned due to the displacement, marker 35 is displayed only as being in the same position in the image in real-time imaging 34. In this example, a button for hiding marker 38 is added to the interface. This allows for better observation, as markers, while useful, may obstruct the observation of anatomical structures. Furthermore, the user can delete markers using a third button 37.

[0114] Figure 5The rotational movement of the treatment head 2 is schematically illustrated. Initially, the treatment head is pointed at the target T within the patient's body (not shown). The focal point 16 of the high-intensity focused ultrasound beam 15 is positioned at the site to be treated. However, the target may not be clearly visible from that particular angle. Therefore, the treatment head rotates 17 about an axis 14 intersecting the focal point 16. Because the focal point is located on the axis of rotation, it does not move. The treatment head 2 and the high-intensity focused ultrasound beam 15 rotate about the axis so that their orientation remains the same and faces the axis 14.

[0115] Figure 6 An embodiment illustrating the working principle of the reference positions is shown schematically. The user can save multiple reference positions along a vein (not shown). The user interface is adapted to display multiple lines 19, each representing a reference position along the direction 20 of the vein. Additionally, the user interface also displays the position of the treatment head. However, the vein is not visible at that position. Therefore, the user selects the vein position 18 they wish to observe. The device automatically calculates which reference position 19 is closest to the user-selected position 18. The treatment head 2 then moves to that position. Due to the increased visibility of the vein at the new position, the user can examine it. The user can then select to move back by clicking the edge of the treatment position 21. The device calculates the nearest reference position and moves the treatment head there; in this example, the nearest reference position is the treatment position.

[0116] Figures 7a-7d The movement of the treatment head (not shown) is illustrated schematically.

[0117] Figure 7a The focal point 100 of the ultrasound treatment head (not shown) in tissue 101 is illustrated. The target T is located in tissue 101 and is not visible in the ultrasound image at the illustrated arrangement of the focal point 100. The focal point 100 is displaced a distance 102 from the target T. However, due to the lack of visibility of the target T, the user will not be aware of the displacement 102. Figure 7a The image acquired by the treatment head is a cross-section in the first plane P1. To make the target T visible, the treatment head moves from the first position along the longitudinal axis of the target T (i.e., along the axis perpendicular to the plane shown here) to a second position, for example, to image a cross-section in plane P2 (see figure). Figure 7b ).

[0118] Figure 7b The image recorded in plane P2 is shown. Plane P2 is parallel to... Figure 7a The target T is located in plane P1, but shifted along its longitudinal axis. The target T is visible in plane P2. Therefore, the user-visible focal point 100 is shifted laterally by a distance 102 from the target T.

[0119] like Figure 7cAs shown, the user thereby moves the treatment head, for example by lateral displacement of the treatment head, to position the focal point, indicated by 100, onto a target within plane P2. Here, the user manually performs this movement and positions the treatment head so that the focal point 100 falls onto the target T. Alternatively, however, the treatment head may be moved automatically or only the distance 102 may be measured to calculate a corrected reference position (see...). Figure 7d ).

[0120] Figure 7d The diagram shows the focal point 100, which has been moved backward along the longitudinal axis of the target T to the corrected reference position. Here, the corrected reference position refers to the position located at the same point along the longitudinal axis of the target T but shifted a distance 102 in a direction parallel to planes P1 and P2. This distance 102 corresponds to... Figure 7a The shift between the target T and the focus 100. Therefore, Figure 7d The focal point 100 is located on the target T, which is not visible in plane P1.

[0121] Those skilled in the art will note that planes P1 and P2 correspond to the same treatment orientation, i.e., the treatment head is about Figures 7a-7d The target orientations are the same. Therefore, the reference position and the corrected reference position are determined with respect to the same processing orientation (i.e., planes P1 and P2 remain parallel).

Claims

1. A device (1) for treating a patient using high-intensity focused ultrasound, the device comprising: - Treatment head (2), which includes a unit for emitting high-intensity focused ultrasound pulses (3), - An imaging device (4) with a probe, preferably an imaging device capable of performing mode B imaging, wherein the probe is preferably disposed within the treatment head (2). - Control unit (10), which is used to control the movement of the probe, The control unit (10) is adapted to perform the movement of the probe about the target (T) during the operation of the imaging device (4).

2. The device according to claim 1, wherein the control unit (10) is adapted to allow user-controllable movement and / or to perform movement of the probe substantially following one of the following axes: - An axis orthogonal to the current imaging plane; - An axis parallel to the main axis of the target; - The projection of the main target axis onto a plane orthogonal to the main ultrasound propagation axis; - The projection of the main target axis onto a plane parallel to the skin surface. The control unit (10) is preferably adapted to restrict movement to one of the aforementioned axes.

3. The apparatus according to claim 2 or 3, wherein the control unit (10) is adapted to store at least one reference position in a memory, and wherein the control unit is further adapted to preferably automatically or when triggered by a user to move the probe to the reference position.

4. The device of claim 3, wherein the control unit is adapted to allow pulses to be emitted only when the treatment head is located in one of at least one of the reference positions.

5. The apparatus according to any one of claims 1 to 4, wherein the control unit is adapted to allow only user-controllable movement of the probe when no pulse is emitted.

6. The apparatus according to any one of the preceding claims, wherein the control unit is adapted to store at least one reference position corresponding to the current position of the treatment head and move the treatment head to the reference position.

7. The apparatus according to any one of the preceding claims, wherein the control unit is adapted to move the probe away from the initial position at a first speed, and then preferably return at a slower second speed.

8. The apparatus according to any one of the preceding claims, wherein the apparatus includes a user interface (39) for triggering the probe to move away from its current position.

9. The apparatus of claim 8, wherein the user interface (39) includes at least one actuator, in particular a monostable button, for triggering the probe to move away from the current position, wherein the control unit (10) is preferably adapted to trigger the probe to move back to its initial position when the user releases the button.

10. The apparatus of claim 8 or 9, wherein the user interface includes two buttons for triggering movement of the probe, each button being used in a direction along a selected axis.

11. The apparatus according to any one of claims 8 to 10, wherein the at least one button is selected from the group consisting of physical or virtual buttons.

12. The apparatus of claim 8 or 11, wherein the user interface (39) includes drag-and-drop controls on the screen.

13. The apparatus according to any one of the preceding claims, wherein the control unit (10) is adapted to perform vibrational movement of the probe generally along one of the aforementioned axes.

14. The apparatus of claim 13, wherein the control unit (10) is adapted to implement vibrational motion selected from the group consisting of: - One or a preset number of vibrations around the initial position; -A limited number of damped vibrations around the current location; - Continuous vibration around the initial position until the preset criteria are met, especially the release button.

15. The apparatus according to claim 14, wherein the control unit (10) is adapted to perform vibrational motion with an amplitude greater than 1 mm, preferably greater than 1 cm.

16. The apparatus according to any one of the preceding claims, wherein the control unit (10) is adapted to perform movement along a trajectory that is at least partially curved.

17. The apparatus of claim 16, comprising at least one of an input interface for user-defined trajectories and a computing unit for automatically calculating trajectories, preferably based on anatomical knowledge.

18. The apparatus according to any one of the preceding claims, wherein the control unit (10) is adapted to perform a movement having an average displacement speed between 0.1 mm / s and 100 mm / s, preferably between 0.5 and 30 mm / s.

19. The apparatus according to any one of the preceding claims, wherein the control unit (10) is adapted to perform movement, particularly along an axis generally orthogonal to the image plane, by means of a control representing the coordinates of the probe.

20. The apparatus according to any one of the preceding claims, comprising a travel limiter (9a, 9b) for limiting the movement of the probe.

21. The apparatus of claim 20, wherein the travel limiters (9a, 9b) are determined by mechanical limitations of the holding device for holding the probe or can be determined by a user interface, preferably by moving the holding device for holding the probe to an extreme point of image acquisition.

22. The apparatus according to any one of the preceding claims, wherein the control unit (10) is further adapted to synchronize the probe movement and image acquisition with the location of the layer to be ultrasound-processed, so as to acquire images at these locations.

23. The apparatus according to any one of the preceding claims, wherein the treatment head of the imaging probe is provided with a balloon (5) defining a cavity for receiving coupling fluid.

24. The apparatus according to any one of the preceding claims, wherein the apparatus (1) is adapted to associate the acquired image with coordinates along the trajectory, and wherein the apparatus includes a display adapted to display an image corresponding to a given coordinate.

25. The apparatus of claim 24 further includes a navigation control, preferably a physical or virtual navigation control, for navigating within the acquired group of images.

26. The apparatus of claim 24, wherein the display includes a first dedicated area for displaying acquired images and navigation and a second dedicated area for displaying images of the area to be ultrasonically processed.

27. The apparatus of claim 24, wherein the display includes a common area for displaying acquired images and for displaying images of the area to be subjected to ultrasound processing, thereby a. When the virtual position of the probe is set to the actual position of the probe, a real-time image of the area requiring ultrasonic treatment is displayed; b. When the virtual position of the probe is set to another position, the corresponding image in the group of acquired images is displayed.

28. The apparatus according to any one of claims 23 to 27, wherein the navigation control is monostable, such that when it is released, the virtual position of the probe returns to the actual position of the probe.

29. The apparatus according to any one of the preceding claims, wherein the control unit is adapted to perform a rotational movement of the treatment head about an axis passing through the focal point (100), and in particular wherein the treatment head is oriented toward the focal point (100) throughout the movement.

30. A method for preparing a patient with therapeutic high-intensity focused ultrasound, preferably using the device according to any one of the preceding claims, comprising the following steps: - Perform the movement of the treatment head away from the target area; - Acquire at least one image that is far from the target area; - Determine the location of the target near the target area based on at least one acquired image; - Perform the movement of the treatment head to the target site; - Optionally, high-intensity focused ultrasound pulses are emitted.

31. The method of claim 30, wherein the movement away from the target location includes at least one of translational movement along the main ultrasound propagation axis, translational movement along an axis perpendicular to the main ultrasound propagation axis, and rotational movement about an axis passing through the focal point (100).

32. The method of claim 30 or 31, wherein at least one of the movements of the treatment head is performed automatically.

33. A method for preparing a patient to be treated with high-intensity focused ultrasound, comprising acquiring a set of 2D images (12a, 12b, 12c, 12d, 12e) before or during treatment, wherein image acquisition includes the following steps - Position the treatment head (2) toward the patient (P); - Define the longitudinal direction (8a, 8b), wherein this direction preferably corresponds to the main axis of the target or the projection of the main axis onto a plane orthogonal to the main ultrasound propagation axis or parallel to the skin. - Perform automatic controlled motion along the longitudinal axis to acquire a set of images, which are preferably orthogonal to the longitudinal axis.

Images