Image-guided focused ultrasound treatment device and targeting apparatus

Abstract

An apparatus, method and kit for X-ray guided focused ultrasound treatment that simplifies focused ultrasound treatment is provided. The device includes an arm (111), a cradle (110), a focused ultrasound (FUS) transducer (120) having a central axis (112) fixed within the cradle and configured to deliver an ultrasound therapeutic energy beam (140) to a treatment location within a patient, and an imaging workstation (180) connected to an X-ray imaging unit. The FUS is further connected to a controller (160) for controlling the application of the FUS. The kit utilizes a coupling member(s).

Description

[Technical field]

[0001] The present invention relates to the field of focused ultrasound (FUS), and in particular to the field of X-ray guided FUS devices. [Background technology]

[0002] FIG. 1 is a high-level schematic diagram of a prior art radiofrequency (RF) nerve ablation procedure. The RF ablation procedure involves thermal destruction of the medial branch nerve that innervates a painful, inflamed joint 70. The RF ablation procedure is performed in a clinic or hospital using x-ray guidance, where the treating physician uses x-ray guidance to guide the tip of a needle 92 to the junction of the lateral and superior articular processes 71 and 72 of the facet joint 73 of the target spine and places the needle along the path of the medial branch nerve 91. The needle 92 generates heat at its tip with RF energy, thermocoagulating tissue around its tip into a small cylinder, including the medial branch nerve. Prior art ablation procedures are invasive, uncomfortable and painful procedures that expose the patient to risks of infection and bleeding. Summary of the Invention [Means for solving the problem]

[0003] The following is a brief summary to provide an initial understanding of the invention. The summary does not necessarily identify key elements or limit the scope of the invention, but rather is merely intended to serve as a prelude to the description that follows.

[0004] An X-ray guided device for image-guided focused ultrasound treatment includes an articulated arm attached to a procedure platform at a base, a cradle fixed to a distal end of the arm, an aiming device fixed within the cradle, a focused ultrasound (FUS) transducer having a central axis fixed within the cradle and configured to deliver an ultrasound therapeutic energy beam to a treatment location within a patient, the FUS transducer connected to a controller for controlling application of the focused ultrasound by the transducer, and an imaging workstation connected to an imaging unit configured to derive imaging data from an X-ray imaging system.

[0005] The apparatus relies on an imaging device, such as an x-ray system, to assist in aiming the position and orientation of the FUS transducer to guide the focal spot to the treatment location.

[0006] These, additional and / or other aspects and / or advantages of the present invention are set forth in the following detailed description, and in some cases may be inferred from the detailed description and / or may be learned by practice of the invention.

[0007] For a better understanding of embodiments of the present invention and to show how the same may be carried into effect, reference will now be made, by way of example only, to the accompanying drawings in which like numerals indicate corresponding elements or sections throughout. [Brief description of the drawings]

[0008] [Figure 1] 1 is a high level schematic diagram of a prior art RF ablation procedure. [Diagram 2] 1 is a high level schematic diagram of an X-ray guided focused ultrasound treatment device and its components, according to some embodiments of the present invention. [Figure 3A] 1 is a high level schematic diagram of a cradle for use in an X-ray guided device, according to some embodiments of the present invention. [Figure 3B] 1 is a side x-ray image of a cradle used in an x-ray guided device, according to some embodiments of the present invention. [Figure 4A] 1 is a high-level schematic diagram and images of an aiming device (mock-up with optical and X-ray markers) used in an X-ray guidance device, according to some embodiments of the present invention. [Figure 4B] 1 is a high-level schematic diagram and images of an aiming device (mock-up with optical and X-ray markers) used in an X-ray guidance device, according to some embodiments of the present invention. [Figure 5A] 1 is a high level flowchart illustrating a method according to some embodiments of the present invention. [Figure 5B] 1 is a high level flowchart illustrating a method according to some embodiments of the present invention. [Figure 6A] 1A-1C illustrate examples of treatment applications according to some embodiments of the present invention used in an X-ray guided device. [Figure 6B] 1A-1C illustrate examples of treatment applications according to some embodiments of the present invention used in an X-ray guided device. [Figure 6C] 1A-1C illustrate examples of treatment applications according to some embodiments of the present invention used in an X-ray guided device. [Figure 7A] FIG. 2 is a high level schematic diagram of an aiming marker of the aiming device. [Figure 7B] FIG. 2 is a high level schematic diagram of an aiming marker of the aiming device. [Figure 8A] 1A-1C are high level schematics and images of different designs of optical markers used in X-ray guided devices according to some embodiments of the present invention. [Figure 8B] 1A-1C are high level schematics and images of different designs of optical markers used in X-ray guided devices according to some embodiments of the present invention. [Figure 9A] 1A-1C are high level schematic diagrams of modified X-ray sights of different designs for use in X-ray guidance devices according to some embodiments of the present invention. [Figure 9B]1A-1C are high level schematic diagrams of modified X-ray sights of different designs for use in X-ray guidance devices according to some embodiments of the present invention. [Figure 10] X-ray image of a modified X-ray sight with proper alignment. [Figure 11A] 4 is a high level flowchart illustrating another method according to some embodiments of the present invention. [Figure 11B] 4 is a high level flowchart illustrating another method according to some embodiments of the present invention. [Figure 12A] 1 is an X-ray image of a FUS transducer including different types of X-ray sights and aiming devices used in an X-ray guided device according to some embodiments of the present invention. [Figure 12B] 1 is an X-ray image of a FUS transducer including different types of X-ray sights and aiming devices used in an X-ray guided device according to some embodiments of the present invention. [Figure 12C] 1 is an X-ray image of a FUS transducer including different types of X-ray sights and aiming devices used in an X-ray guided device according to some embodiments of the present invention. [Figure 12D] 1 is an X-ray image of a FUS transducer including different types of X-ray sights and aiming devices used in an X-ray guided device according to some embodiments of the present invention. [Figure 12E] 1 is an X-ray image of a FUS transducer including different types of X-ray sights and aiming devices used in an X-ray guided device according to some embodiments of the present invention. [Figure 12F] 1 is an X-ray image of a FUS transducer including different types of X-ray sights and aiming devices used in an X-ray guided device according to some embodiments of the present invention. [Figure 12G] 1 is an X-ray image of a FUS transducer including different types of X-ray sights and aiming devices used in an X-ray guided device according to some embodiments of the present invention. [Figure 12H]1 is an X-ray image of a FUS transducer including different types of X-ray sights and aiming devices used in an X-ray guided device according to some embodiments of the present invention. [Figure 13A] 13 is a screen dump of a baseline image of device imaging workstation image processing for an AP image with a transducer in place according to some embodiments of the present invention. [Figure 13B] 13 is a screen dump of a baseline image of device imaging workstation image processing for an AP image with a transducer in place according to some embodiments of the present invention. [Figure 13C] 13 is a screen dump of device imaging workstation image processing results for an AP image with a transducer in place according to some embodiments of the present invention. [Figure 14A] 1 is a schematic diagram showing the alignment of an imaging probe and a therapeutic ultrasound probe in an ultrasound guidance device to position a therapeutic acoustic focal point at the center of an ultrasound image. [Figure 14B] 1 is a schematic diagram showing the alignment of an imaging probe and a therapeutic ultrasound probe in an ultrasound guidance device to position a therapeutic acoustic focal point at the center of an ultrasound image. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0009] In the following description, various aspects of the present invention are described. For the purpose of explanation, specific configurations and details are described to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced without the specific details presented herein. Furthermore, well-known features may be omitted or simplified so as not to obscure the present invention. With particular reference to the drawings, it is emphasized that the details shown are examples and are merely for the purpose of explanatory discussion of the present invention, presented to provide what is believed to be the most useful and understandable explanation of the principles and conceptual aspects of the present invention. In this regard, no attempt is made to show the structural details of the present invention in more detail than is necessary for a fundamental understanding of the invention, and the description, taken together with the drawings, will make apparent to those skilled in the art how multiple forms of the present invention may be embodied in practice.

[0010] Before at least one embodiment of the invention is described in detail, it will be understood that the application of the invention is not limited to the details of construction and the arrangement of parts set forth in the following description or illustrated in the drawings. The invention is applicable to combinations of the disclosed embodiments and to other embodiments that can be practiced or carried out in various ways. It will also be understood that the language and terminology used herein is for the purpose of description and should not be regarded as limiting.

[0011] Unless otherwise specified, and as will be apparent from the following description, throughout the specification discussions using terms such as "processing," "calculating," "computing," "determining," "enhancing," and the like will be understood to refer to operations and / or processes of a computer or computing system or similar electronic computing device that manipulate and / or transform data represented as physical quantities, such as electronic quantities in the registers and / or memory of the computing system, into other data similarly represented as physical quantities in the memory, registers, or other such information storage, transmission or display device of the computing system.

[0012] An X-ray guided apparatus and method for image-guided focused ultrasound (FUS) treatment is provided. The apparatus includes an articulated arm attached to a procedure platform at a base, a cradle fixed to a distal end of the arm, an aiming device, an FUS transducer and an X-ray aimer having a central axis fixed in the cradle and configured to deliver an ultrasound therapeutic energy beam to a treatment location in a target patient, the FUS transducer and the X-ray aimer being connected to a controller configured to control the application of focused ultrasound by the transducer, and an imaging workstation connected to an imaging unit configured to derive imaging data from an X-ray imaging system. The apparatus may be used in a clinic or hospital equipped with a suitable imaging device such as a C-arm, fluoroscopy or any common X-ray imaging system. The apparatus may be guided by a pre-operative imaging system, in which case images taken by a different imaging system (e.g. CT, MRI or any other system) may be fused, registered and superimposed with images generated during the FUS treatment procedure. The device may be used in combination with a C-arm, O-arm, G-arm, X-ray computed tomography (CT) or any other X-ray device. The device may be compatible with any ultrasound imaging system.

[0013] 2 is a high-level schematic diagram of an X-ray guided device 100 for an image-guided FUS procedure, according to some embodiments of the present invention. The device 100 includes an articulated arm 111 attached to a procedure platform 90 at a base. In an embodiment, the procedure platform 90 can include at least one of an operating room table, an imaging table, and a dedicated cart, where the cart is designed to carry electronics and other device accessories, and the cart wheels are designed to be locked to prevent movement of the cart. The device 100 can further include a cradle 110 attached to a distal end of the arm 111. The device 100 can further include a coupling accessory 125 configured to acoustically couple the transducer surface 120 to the surface 83 of the tissue 80.

[0014] The device 100 may further include a FUS transducer 120 having a central axis 112 configured to be secured within the cradle 110 and to transmit a FUS energy beam 140 to a treatment location 141 within the patient. The device 100 may further include a trigger 119 configured to terminate the delivery of the FUS energy 140. The device 100 may further include a controller 160 configured to control the FUS energy delivery by the therapeutic FUS transducer 120, which may be controlled by a user interface. The device 100 may further include a screen 165. The screen 165 provides technical information to the physician, such as, but not limited to, selected power level, sonication duration, informative maintenance and service messages, etc. The screen 165 may include clinical information that is essentially provided by the workstation 180, or vice versa. The device 100 may further include an aiming device 130 configured to be secured within the cradle 110. In an embodiment, the cradle 110 may be further configured such that the FUS transducer 120 and the aiming device 130 may be secured therein simultaneously. In an embodiment, an X-ray aimer 150 may be attached to the FUS transducer 120 to enable X-ray guidance. In an embodiment, the cradle 110 may include several degrees of freedom of movement, such as, but not limited to, front-back (A-P; anterior-posterior), top-bottom (S-I; superior-inferior), left-right (L-R; left-right), etc. In an embodiment, the cradle 110 may be configured to smoothly accommodate insertion, locking, and unlocking of the aiming device and the FUS transducer. In an embodiment, the cradle 110, the FUS transducer 120, the aiming device 130, and the X-ray aimer 150 are constructed as a single unit.

[0015] The device 100 may further include an X-ray imaging system including an X-ray intensifier 85 and an X-ray source 86, which are connected as an X-ray imaging system. In an embodiment, the X-ray imaging system may be configured to image a region 91 of the tissue 80 that includes the treatment location 141. In an embodiment, the X-ray imaging may be performed before and during the FUS procedure. In an embodiment, the device 100 may be configured to accommodate at least one of the following X-ray types: C-arm, O-arm, G-arm, and any other common X-ray type.

[0016] The apparatus 100 may further include a workstation 180 connected to the X-ray intensifier 85 of the X-ray imaging system, the workstation 180 configured to derive imaging data from the X-ray imaging system. In an embodiment, the controller 160 and the screen 165 may be combined in the workstation 180.

[0017] In an embodiment, the articulated arm 111 may be a mechanical or robotic arm attached to the procedure platform 90. In an embodiment, the articulated arm 111 may include several degrees of freedom, such as, but not limited to, front-back (A-P), up-down (S-I), left-right (L-R), and tilts, such as yaw, pitch, and roll, to enable alignment of the FUS energy beam 140 to a desired treatment location 141 within a patient. In an embodiment, the articulated arm 111 may be adjusted manually and / or electronically and / or automatically to align the cradle 110 to a predetermined orientation and position.

[0018] In an embodiment, the device 100 may further include a manual or controlled remote steering module configured to remotely control the position and orientation of the articulated arm 111. The steering module may include at least one rod connected to the articulated arm 111 in a non-limiting manner and a control unit configured to control the movement of the articulated arm 111. The rod may be made of at least one of metal, plastic, wood, and carbon. Remote control of the articulated arm 111 may minimize the practitioner's exposure to X-ray radiation. In an embodiment, the control unit of the steering module may be implemented in the controller 160 and / or the workstation 180.

[0019] In one embodiment, the coupling accessory 125 is designed to mimic the inner shape of the FUS transducer 120 to enhance acoustic coupling quality and provide a desired flexibility to enhance coupling with the patient's skin 83. In one embodiment, the coupling accessory 125 may be a balloon or membrane filled with a fluid or gel. The balloon or membrane may be secured to the cradle 110 using elastics and / or rings that secure the coupling accessory 125 attached to the cradle 110 during the procedure.

[0020] In an embodiment, the coupling accessory 125 may include a gel pad. The gel pad 125 may be designed to mimic the inner shape of the FUS transducer 120, including a margin to allow for angular steering flexibility. The margin allows the practitioner to steer the cradle 110 and the FUS transducer 120 at different angular positions without adversely affecting the coupling between the FUS transducer and the gel pad 125. In an embodiment, the gel pad 125 may be designed with a shape that wraps around the cradle 110 to secure the gel pad 125 to the cradle 110 during insertion of the FUS transducer 120. The gel pad 125 may be designed with a convex shape on the side that is attached to the patient's skin 83. The convex shape allows the practitioner to steer the cradle 110 at different angular positions without affecting the coupling between the gel pad 125 and the patient's skin 83. In an embodiment, the coupling accessory 125 may be at least one of optically transparent, acoustically transparent, and radiolucent. In one embodiment, the coupling accessory 125 can be designed to guide the positioning of the transducer 120 at a predetermined penetration angle of the acoustic beam 140 into the tissue 80 .

[0021] In one embodiment, the FUS transducer 120 can be configured to deliver FUS energy 140 to different depths depending on the location of the treatment site 141 using at least one of different sizes of the coupling accessories 125 and / or tuning of the phased array transducer elements as electronic steering.

[0022] In an embodiment, the FUS transducer 120 may be further configured to project the FUS beam energy 140 in a focused manner onto the treatment location 141 as a focal spot location while utilizing adjacent bone structures and preventing damage to adjacent soft tissue. In an embodiment, the FUS transducer 120 may include at least one of a single element or a phased array of elements or two or more annular elements. In an embodiment, the FUS transducer 120 may include at least two annular ring elements geometrically focused to a depth within a range 141A within the closed environment of the treatment location 141 (see, for example, FIG. 3B). The placement of the annular elements of the FUS transducer 120 allows the acoustic focus of the FUS beam 140 to be placed proximal or distal to the geometric focal depth by manipulating each of the at least two annular elements to vibrate with different phases. This allows a single FUS transducer 120 to mimic a series of transducers with the same aperture size but different geometric focal lengths. This allows the practitioner to adjust the depth of the acoustic focus of the FUS beam 140 during the procedure to match the depth of the treatment location 141, thereby increasing the efficacy of the treatment. In an embodiment, the different annular elements of the transducer may be driven at slightly different frequencies (incoherent modes) resulting in a continuous change in relative phase between the elements to create an elongated acoustic focus. In an embodiment, at least one of the annular ring elements of the FUS transducer 120 may be configured to be turned off to avoid the FUS energy beam 140 hitting vertebral bony processes or other acoustically absorbing structures in the beam path that should not be exposed to high intensity acoustic energy. In an embodiment, the central axis 112 of the FUS transducer 120 may be tilted relative to the patient's back so that the energy beam 140 is delivered onto the treatment location 141 on the spine at an angle relative to the bony structures, thereby avoiding situations where the FUS energy 140 may be blocked (e.g., by the vertebral processes and lamina). An angle may be selected such that the angle of incidence on the bone surface can be less than the angle of refraction so that most of the FUS energy 140 is absorbed by the bone and not reflected.In one embodiment, the device 100 and the projected FUS energy 140 can be used to optimize the angle of incidence of the acoustic energy to the bone to maximize absorption of the energy by the bone. When the beam angle is perpendicular to the bone, absorption of acoustic energy by the bone is greatest.

[0023] 3A is a high-level schematic diagram of the cradle 110. In an embodiment, the cradle 110 is designed to have a geometric conical shape such that the projection of the cone boundary coincides with the FUS beam 140 generated by the FUS transducer 120. In an embodiment, the conical shape of the cradle 110 is designed such that the apex of the projection of the side of the cone (e.g., the intersection of the projection of the cone boundary) corresponds to the focal depth of the FUS energy beam 140. Thus, as shown in FIG. 3B, the conical shaped cradle 110 can be used as a marker visible on an X-ray image to guide the focusing of the FUS energy beam 140 onto the treatment location 141. FIG. 3B is a high-level schematic diagram of a side X-ray image of the cradle 110, according to some embodiments of the present invention. In an embodiment, the workstation 180 may further include a software module configured to receive the lateral x-ray image of the cradle 110, transmit the lateral x-ray image of the cradle 110 to the screen 165, and recognize the projections of the cone boundaries of the cradle 110 by at least one computer processor using image processing known in the art, and display these projections on the lateral x-ray image of the cradle 110. In a preferred embodiment, the intersection of the projections of the cone boundaries represents the apex of the side projection of the cone, which corresponds to the focal depth of the FUS energy beam 140. Thus, the apex of the side projection of the cone can be used to assist the practitioner in accurately and safely navigating the FUS energy beam 140 to the treatment location 141. The cone form of the cradle 110 is invariant in a wide range of lateral projection images in lateral view. Thus, the cone shape, including the apex, can be restored from various viewpoints. In an embodiment, the cradle 110 can include at least one of a radiopaque material, a radiolucent material coated with a radiopaque material, and a semi-radiopaque material.

[0024] In an embodiment, image-guided invasive procedures, particularly frameless stereotactic procedures, include a stereoscopic optical image sensor that tracks objects tagged with special markers to aid in the alignment and navigation of the FUS energy beam 140 to the target location 141. Such markers are typically large spheres that can be easily identified in the field of view, or similarly can be encoded black and white barcode-like labels that uniquely identify specific objects and track them in the field of view. Spheres are particularly common because their shape is nearly invariant to changes in viewing angle. In 3D imaging modalities such as CT or MR, the markers are one or two-dimensional and made of radiopaque or magnetic materials to make them visible. For X-ray (fluoroscopy) guidance, a 2D template with radiopaque markers is typically used for alignment and tracking with preoperative 3D imaging data.

[0025] 4A is a high level schematic diagram of an aiming device 130 disposed within a cradle 110, according to some embodiments of the present invention. In an embodiment, the aiming device 130 may include a mockup 115 configured to be disposed within the cradle 110. In an embodiment, the mockup 115 may include a transparent material (e.g., Perspex®) that allows the physical to keep the patient's skin 83 within view. In an embodiment, the mockup 115 may include a radiolucent material (e.g., Perspex® and carbon fiber) to produce a clear x-ray image of the target location 141.

[0026] In some embodiments, the aiming device 130 may further include at least one optical marker holder 113. In some embodiments, the optical marker holder 113 may include at least one laser pointer. In some embodiments, the at least one optical marker holder 113 may be aligned to create a straight line along the central axis 112 of the FUS transducer 120 and the cradle 110. In some embodiments, the at least one optical marker holder 113 may be configured to create an additional line to ascertain the position of the cradle 110 and the FUS transducer 120 relative to a normal to the X-ray imaging system field of view 85.

[0027] 4B is a high-level schematic diagram of the mock-up 115 and the optical marker holder 113 of the aiming device 130 according to some embodiments of the present invention. In an embodiment, the aiming device 130 may further include at least two X-ray aiming markers 133, 134 arranged on the vertical axis of the at least one optical marker holder 113. In an embodiment, the X-ray aiming markers 133, 134 may be rings. At least one X-ray aiming marker 133, 134 may include at least one groove 133A. In an embodiment, at least one of the mock-up 115 and the X-ray aiming markers 133, 134 may be asymmetric, and the asymmetry may be optically and radiologically visible, allowing the practitioner to correlate both views and determine the direction and angle of movement as needed to mutually align the cradle 110 with the X-ray intensifier 85 along the central axis 112.

[0028] In an embodiment, at least one of mockup 115 and optical marker holder 113 may have at least one X-ray fiducial marker so that the orientation of mockup 115 can be found in an X-ray image. In an embodiment, optical marker holder 113 may have a separate on and off switch affixed to or located adjacent mockup 115.

[0029] 5A-5B are a high level flow chart illustrating a method according to some embodiments of the present invention. At step 510, at least one radiopaque marker is placed in the center of the x-ray intensifier 85 (see, e.g., 70A in FIG. 6A). At step 515, the patient is placed in a prone position on the procedure platform 90. After the patient is positioned on the table, the relative height of the table and C-arm is adjusted so that both the patient's spine and the cradle are visible within the x-ray field of view. Once the height is set, it remains locked throughout the procedure. This adjustment is made by manipulating the lateral x-ray image and the table height and C-arm height.

[0030] In step 520, the x-ray arm 87 (see FIG. 2) is moved horizontally to place the radiopaque marker 70A visible in the x-ray image over the treatment location 141 in the patient (see, for example, 70A-2 in FIG. 6A). In one embodiment, the x-ray intensifier 85 is placed at an angle to the treatment location 141 so that the radiopaque marker 70A can be overlaid on the treatment location 141. It is important to note that if an angle is set, it is done before step 520. This angle will be the desired viewing angle. This is also the angle of FUS energy penetration into the patient's body. In step 525, the radiopaque marker 70B is placed on the patient's skin 83 at a specific location selected by the practitioner by temporarily placing at least one temporary marker 84 (e.g., a needle tip) on the patient's skin 83 after verifying the treatment location 141 with the radiopaque marker 70A-2 during the x-ray image (see, for example, FIG. 6B). In an embodiment, only / also marker 70B may be a visible marker that does not have significant acoustic absorption to avoid near-field heating and damage to the patient's skin from the FUS energy.

[0031] In step 530, the docking accessory 125 is placed over the marker 70B on the patient's skin 83 as in step 525. In step 535, the cradle 110 with the mock-up 115 is placed over the docking accessory 125 (see, for example, FIG. 6B).

[0032] At step 540, at least one optical marker holder 113 on the mockup 115 is turned on and the cradle 110 is aligned using the articulated arm 111 of the device 100 to direct the collinear laser at the radiopaque marker 70B on the patient's skin 83 and the radiopaque marker 70A on the intensifier 85. At step 545, an x-ray image is taken to verify the alignment of the cradle 110 and mockup 115 with respect to the normal to the center of the x-ray imaging system field of view along the axis 112. At step 550, the alignment is verified. If the radiopaque markers 70A-2, 70B-1 overlap on the x-ray image of step 545, then the cradle 110 and mockup 115 are aligned with the normal to the center of the x-ray imaging system field of view along the axis 112 (see, for example, FIG. 6C). If the radiopaque markers 70A-2, 70B-1 do not overlap on the X-ray image of step 545, step 535 must be performed again. In an embodiment, the alignment of the cradle 110 and mockup 115 with the normal of the center of the X-ray imaging system field of view may be verified using at least two X-ray aiming markers 133, 134 arranged on the vertical axis of at least one optical marker holder 113. When the cradle 110 and mockup 115 are aligned with the normal of the center of the X-ray imaging system field of view along the axis 112, the X-ray aiming markers 133, 134 will appear concentric on the X-ray image of step 545 (see, for example, FIG. 7A). If the X-ray aiming markers 133, 134 do not appear concentric on the X-ray image of step 545 (see, for example, FIG. 7B), step 535 must be repeated. A range of position and angle errors of the aiming device 130 may be tolerated. An indication of the allowable error may be presented to the practitioner by the shape and / or size of the X-ray aiming markers 133, 134, such as the gap between the diameters of the aiming markers, which must remain visible around the inner X-ray aiming marker 133 to indicate alignment within error limits. In an embodiment, a determination of the quality of the cradle and aiming device alignment at this step may also be made based solely on the optical markers without the need for X-ray imaging.

[0033] In one embodiment, the alignment of the cradle 110 may be based on a depth image produced by a depth camera located on the cradle 110 or FUS transducer 120 facing the intensifier 85. The cradle 110 is aligned such that the plane of the intensifier 85 is parallel to the cradle 110 through depth image analysis and the shape of the intensifier 85 is aligned with the center of the cradle 110 or FUS transducer 120 such that the cradle 110, the intensifier 85 and the central axis 112 are collinear. In one embodiment, the alignment of the cradle 110 may be based on at least two distance sensors such as, but not limited to, ultrasonic, RF, IR or laser sensors located on the cradle 110 or FUS transducer 120 facing the intensifier 85. These sensors can measure the distance from the intensifier 85 and indicate the alignment required to align the cradle 110 parallel to the face of the intensifier 85. Complimentary to the distance sensors, a camera located on the cradle 110 or FUS transducer 120 facing the intensifier 85 produces an image of the round shape of the intensifier 85 and indicates the position of the cradle 110 relative to the intensifier 85 and the direction in which the cradle 110 should be moved to align the central axis 112, the intensifier 85 and the cradle 110 with respect to each other. In an embodiment, the alignment of the cradle 110 can be based on at least two dual-axis inclinometers or angulation sensors located on the cradle 110 or FUS transducer 120 and on the intensifier 85. These sensors can measure the angle of the cradle 110 or FUS transducer 120 and the angle of the intensifier 85 and indicate the alignment required to align the cradle 110 parallel to the face of the intensifier 85. This can be done based on absolute angle measurements or according to a calibration performed in a baseline parallel orientation.Complementing the angle sensor, a camera located on the cradle 110 or FUS transducer 120 facing the intensifier 85 produces an image of the round shape of the intensifier 85 to indicate the position of the cradle 110 relative to the intensifier 85 and the direction in which the cradle 110 should be moved to mutually align the central axis of the intensifier 85 with the cradle 110. The inclinometer or angulation sensor may be wired or wireless and may use any existing technology to measure the required angle.

[0034] In step 555, the C-arm 87 of the X-ray imaging system is tilted laterally, preferably at a right angle to the cradle axis 112, in order to ascertain the depth of the treatment location 141 with the FUS beam path 140 recognized by the software module of the workstation 180 (see, for example, FIG. 3B). The tilting of the C-arm 87 should preferably be performed on a single axis. When other types of imaging such as CT, ultrasound, and others are used for guidance, the position of the transducer focus can also be extrapolated from the image. Once the treatment depth has been ascertained within the applicable focus range, the C-arm 87 should be returned to its previous vertical position. The C-arm 87 should be repositioned according to the angle of the mockup 115, with the optical marker holder 113 facing over the radiopaque markers 70A and 70B. In an embodiment, an X-ray image can be taken again to ascertain the alignment.

[0035] At step 560, the mockup 115 is removed from the cradle 110 and the transducer 120 is inserted into the cradle 110. At step 565, the X-ray sight 150 is placed into the FUS transducer 120. At step 570, an X-ray image is taken using the X-ray sight 150 to ensure that the cradle 110 and FUS transducer 120 are aligned normal to the center of the X-ray imaging system field of view along axis 112 as in step 550. At step 575, the FUS acoustic energy beam 140 is delivered to ablate the target location 141. In an embodiment, the FUS acoustic energy can be delivered at a low level first to ensure target feedback for the patient before delivering the ablation level energy pulse.

[0036] 8A-8B are high level schematic diagrams of the optical marker holder in different positions according to some embodiments of the present invention. In these embodiments of the present invention, the use of mock-up 115 is not necessary because the laser beam originating from optical marker 113 or mirror 114 is aligned with the central axis 112 of the C-arm and the central radiopaque marker of the intensifier plate is adjusted to coincide with the treatment target on the X-ray image. Instead, an X-ray / optical sight attached directly to the FUS transducer may be used.

[0037] The optical marker holder 113 (FIG. 8A) or mirror 114 (FIG. 8B) may be attached to the center of the C-arm (X-ray) intensifier plate 85. The optical marker holder 113 or mirror 114 may be designed to allow manual and / or automatic angular alignment to the intensifier plate and to be aligned with the central axis 112 (FIG. 2) of the C-arm by projecting a laser beam to the center of the C-arm source 86 (FIG. 2). The optical marker 113 or mirror 114 may be attached to or consist of a radiopaque marker visible on an X-ray image. The optical marker 113 or mirror 114 may be appropriately placed at the center of the radiopaque marker. In FIG. 8A, the mirror 114 has angular alignment capability and the optical marker 113 can be adjusted to aim at the center of this mirror.

[0038] 9A-9B are high-level schematic diagrams of a modified X-ray sight 150 secured within a FUS transducer 120, according to some embodiments of the present invention. The modified X-ray sight 150 may be used as both an optical sight and an X-ray sight.

[0039] The modified x-ray sight 150 is placed in a socket or recess of the FUS transducer 120 along the central axis 112 of the FUS transducer and may include two or more x-ray sighting markers, such as rings 133, 134, placed along the vertical axis of the FUS transducer. To align the FUS transducer to the target, the optical markers must be visible in the center of the upper ring 133 and the lower ring 134. To ensure that the FUS transducer is correctly aligned to the C-arm central axis 112, the radiopaque rings 133, 134 must appear concentric on the x-ray image (FIG. 7A, FIG. 10). If the rings do not appear concentric on the image (FIG. 7B) or the physician observes movement, the physician should repeat the placement procedure.

[0040] A range of position and angle error may be tolerated for the modified x-ray sight 150. An indication of the tolerated error may be provided to the physician by the shape and / or size of the x-ray sight markers 133, 134 (FIGS. 7A-7B), such as the gap between the diameters of the rings, which must remain visible around the inner ring 133 to indicate alignment within the error limits.

[0041] Reference is now made to FIGS. 11A-11B, which are a simplified flow diagram of a method 1100 for image-guided focused ultrasound treatment of a patient in some embodiments of this configuration.

[0042] A radiopaque marker may be placed at the center of the x-ray intensifier plate, step 1110. An optical marker holder may then be placed at the center of the x-ray intensifier and aimed at the x-ray source, as per step 1115.

[0043] At step 1120, the patient is placed in a prone position on the procedure platform 90. After the patient is positioned on the table, the relative height of the table and C-arm is adjusted so that both the patient's spine and the cradle are visible in the x-ray field of view. Once the height is set, it remains locked throughout the procedure. This adjustment is made by manipulating the lateral x-ray image and the table height and C-arm height.

[0044] In step 1125, the x-ray arm 87 is moved horizontally to place a radiopaque marker 70A visible in the x-ray image overlaid on the treatment location 141 within the patient (see, for example, 70A-2 in FIG. 6A). In one embodiment, the x-ray intensifier 85 is placed at an angle relative to the treatment location 141 so that the radiopaque marker 70A can be overlaid on the treatment location 141. It is important to note that if an angle is set, it is set prior to step 520. This angle will be the desired viewing angle. This is also the angle of FUS energy penetration into the patient's body.

[0045] At step 1135, the coupling accessory 125 is placed on the skin 83. At step 1140, the cradle 110 with the FUS transducer 120 is placed on the coupling accessory 125. At step 1145, the modified X-ray sight 150 is placed in the central hole of the FUS transducer 120.

[0046] At least one optical marker holder (FIGS. 8A-8B) on the X-ray intensifier 85 is turned on in step 1150, and the cradle is aligned according to step 1155 using a laser aimed at a central marker, one on the upper ring 133 of the modified X-ray sight 150 and the other on the lower ring 134 of the modified X-ray sight 150 (FIG. 9A). If the aiming markers 133, 134 appear concentric in the X-ray image, the cradle is aligned (FIG. 6A). If the aiming markers 133, 134 do not appear concentric in the X-ray image, step 1155 must be repeated. A range of position and angle errors of the modified X-ray sight may be tolerated. An indication of the allowable error can be presented to the physician by the shape and / or size of the aiming markers 133, 134 (FIGS. 7A-7B), such as the gap between the diameters of the rings, which must remain visible around the inner ring 133 to indicate alignment within error limits. In an embodiment, a determination of the quality of the alignment of the cradle and aiming device can also be made based solely on the optical markers without the need for x-ray imaging.

[0047] The treatment depth must be verified in step 1170. The X-ray arm is tilted laterally, preferably 90 degrees, relative to the cradle axis 112 and the depth of the treatment location shall be verified using the superimposition of the beam path and focal point of the imaging workstation (FIG. 3B).

[0048] Once the treatment location depth is confirmed to be within the applicable focal range, the physician delivers acoustic energy to ablate the target tissue according to step 1175. In an embodiment, acoustic energy can also be delivered at a lower level first to confirm target feedback for each patient before delivering an ablation level energy pulse.

[0049] According to an embodiment, the shape of the X-ray sight 150 and the aiming device 130 can be designed in a manner to reduce interference in image quality. Figures 12A-12G are high-level schematic diagrams of X-ray images of FUS transducer 120 with various X-ray sights 150 (Figures 12A-12C) according to some embodiments of the present invention, where Figures 12D-12G are high-level schematic diagrams of X-ray images of aiming device 130 with different designs. Image 12H shows the transducer without any sight inserted for reference.

[0050] In all presented X-ray sights, the design is optimized to minimize artifacts by eliminating sharp interfaces between materials of different radiopacity that are irrelevant to the sight, in order to make the image as clear as possible. A similar effect is seen (to a greater extent) in the design of the sight, as can be seen in Figures 12F-12G, where Figure 12D shows a design with a lot of artifacts and Figure 12E shows a clear design that is also optically transparent.

[0051] Additionally, the lower portion of the X-ray sight 150 has a thick, disk-shaped plastic portion that increases the overall radiopacity of the sight and allows for more balanced imaging of human tissue (in terms of gain and image saturation) through the FUS transducer 120 opening, as seen in Figures 12H-12G.

[0052] 13A-13C are high-level schematic diagrams of x-ray images of a treatment target with and without a FUS transducer in a cradle, respectively, in accordance with some embodiments of the present invention: Fig. 13A shows an AP image of the FUS transducer as shown on the device workstation during the procedure;

[0053] Once the placement process is over and the cradle is aligned and fixed on the central axis 112, the workstation identifies and saves the circular shape of the cradle in the image and uses image processing to replace the dark areas caused by the radiopacity of the transducer (FIG. 13A) with a clear image of the inner area of ​​the cradle containing the treatment target (FIG. 13B), thus avoiding the shielding of the patient's anatomy. This produces a clear image of the treatment target with the transducer in the cradle when ready for sonication (FIG. 13C). The physician can then view the image, which now shows the radiolucent transducer, providing anatomical information that was blocked by the opaque transducer. The importance of such an image is to help the physician confirm and verify the treatment position and alert in case of possible patient movement. These features are crucial to improving the safety profile and efficacy results of the device.

[0054] Another embodiment of the device is to use an ultrasound (US) imaging probe to view the treatment target and align the FUS transducer to the treatment target instead of using imaging with an X-ray device. Figure 14A is a schematic diagram of a US imaging probe attached to the center of the FUS transducer. An alignment adapter is used to align the US imaging probe to be contiguous with the transducer central axis.

[0055] Since the simultaneous operation of the imaging probe and transducer US sonication greatly degrades the quality of the ultrasound image and even completely blocks the imaging capability, an alternating pulsing method is described in FIG. 14B. The FUS energy will be pulsed with short pauses. During the pauses, an artifact- or degradation-free image is captured from the ultrasound imaging stream and presented to the imaging workstation until it is replaced by the next distortion-free image captured during the next energy pause. In this way, the imaging refresh rate will be lower, but image feedback can still be generated during sonication. Due to the large level of expected image degradation, basic image processing techniques can be used to confirm distortion-free images. Alternatively, the pulses that generate the therapeutic sonic waves may be generated in a manner that minimizes artifacts and degradation of the ultrasound image. It is important to note that the uniqueness of the above embodiment is that any common ultrasound imaging system with the imaging characteristics required for the clinical application can be used as is as a guidance for the focused ultrasound system without the need for modification or connection to a gating signal.

[0056] In the above description, the embodiments are examples or realizations of the invention. The various appearances of "one embodiment," "embodiment," "an embodiment," or "some embodiments" do not necessarily all refer to the same embodiment. Although various features of the invention may be described in the context of a single embodiment, these features may be provided separately or in any suitable combination. Conversely, although the invention may be described herein for clarity in the context of separate embodiments, the invention may be implemented in a single embodiment. An embodiment of the invention may include features from different embodiments disclosed above, and an embodiment may incorporate elements from other embodiments disclosed above. The disclosure of elements of the invention in the context of a particular embodiment is not to be construed as limiting their use to only that particular embodiment. Furthermore, it is understood that the invention may be implemented or practiced in various ways, and that the invention may be implemented in an embodiment other than that outlined in the above description.

[0057] The present invention is not limited to the figures or the corresponding description. For example, the flow may not proceed through each illustrated box or state, or in exactly the same order as illustrated or described. Unless otherwise specified, the meanings of technical and scientific terms used herein are generally understood by those skilled in the art to which the present invention belongs. Although the present invention is described with respect to a limited number of embodiments, these are not to be construed as limitations on the scope of the present invention, but as illustrations of some of the preferred embodiments. Other possible variations, modifications, and applications are also within the scope of the present invention. Therefore, the scope of the present invention is not to be limited by what has been described above, but by the appended claims and their legal equivalents.

Claims

1. 1. An X-ray guided focused ultrasound (FUS) treatment device, comprising: an FUS transducer having a central axis and configured to deliver an FUS therapeutic energy beam to a treatment location; an aiming device comprising two or more X-ray aiming markers arranged along an axis coincident with the central axis of the FUS transducer; Equipped with the two or more X-ray targeting markers have different sizes; The difference in size of the two or more x-ray targeting markers indicates alignment within error limits of the device.

2. The apparatus of claim 1 , wherein the two or more X-ray targeting markers have different shapes.

3. The apparatus of claim 1 or 2, wherein the two or more X-ray targeting markers have different shapes and sizes.

4. The apparatus of any one of claims 1 to 3, wherein the aiming device is configured to be placed within a socket of the FUS transducer.

5. The apparatus of claim 1 , wherein the two or more X-ray targeting markers are rings.

6. 1. An X-ray guided focused ultrasound (FUS) treatment device, comprising: an FUS transducer having a central axis and configured to deliver an FUS therapeutic energy beam to a treatment location; an aiming device comprising two or more X-ray aiming markers arranged along an axis coincident with the central axis of the FUS transducer; a cradle configured to have the FUS transducer disposed therein; and Equipped with The aiming device is a mockup configured to be placed in the cradle; and an optical marker holder configured to hold an optical marker and aligned along the central axis of the FUS transducer.

7. The apparatus of claim 6 , wherein the optical marker is a laser.

8. 8. The apparatus of claim 6 or 7, wherein the mock-up is made from a light-transmitting material.

9. The apparatus according to any one of claims 6 to 8, wherein the mock-up is made from a radiolucent material.

10. 1. An X-ray guided focused ultrasound (FUS) treatment device, comprising: an FUS transducer having a central axis and configured to deliver an FUS therapeutic energy beam to a treatment location; an aiming device comprising two or more X-ray aiming markers arranged along an axis coincident with the central axis of the FUS transducer; a radiopaque marker configured to be positioned at the center of the x-ray intensifier; a marker configured to be placed on the patient's skin above the treatment location; An apparatus comprising:

11. The device of claim 10 , wherein the marker configured to be placed on the skin is a visible marker.

12. The device of claim 10 or 11, wherein the marker configured to be placed on the skin is a radiopaque marker.

13. 13. The apparatus of claim 10, wherein the radiopaque marker configured to be placed on an X-ray intensifier and the marker configured to be placed on the skin are configured to be identified in at least one of a clinical image and a radiological image.

14. The apparatus of claim 6 comprising a depth camera configured to be disposed on one of the cradle and the FUS transducer.

15. The apparatus of claim 6 , comprising at least two distance sensors and a camera disposed on one of the cradle and the FUS transducer.

16. The apparatus of claim 6 , comprising at least two angle sensors and a camera disposed on one of the cradle and the FUS transducer.

17. The apparatus of claim 6 , wherein the aiming device is configured to be disposed within the cradle.

18. 1. An X-ray guided focused ultrasound (FUS) treatment device, comprising: an FUS transducer having a central axis and configured to deliver an FUS therapeutic energy beam to a treatment location; an aiming device comprising two or more X-ray aiming markers arranged along an axis coincident with the central axis of the FUS transducer; Equipped with The apparatus, wherein the aiming device comprises an optical marker holder configured to hold an optical marker and configured to be positioned in an x-ray intensifier.

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