System and method for aligning treatment tools in x-ray or ultrasound device environment

Abstract

The present disclosure relates to systems and methods for aligning treatment tools in an X-ray or ultrasound device environment. The system may include a calibration plate attachable to an X-ray device and including at least one radiopaque marker and at least one optical marker at predetermined locations within the calibration plate; a camera attachable to the treatment tool at a predetermined position and orientation with respect to the treatment tool; and a processing unit in communication with the camera and an X-ray imaging unit of the X-ray device, the processing unit configured to determine a position and orientation of the treatment tool relative to the X-ray device, and to display on the display a visual indicator indicative of the determined position and orientation of the treatment tool. The user may aim and / or align the treatment tool based on the visual indicator displayed on the display.

Description

[0001] This application is a divisional application of the patent application with application number 202080038693.7 and invention name “System and method for aiming and aligning therapeutic tools in an X-ray device or ultrasound device environment”, whose international application date is March 25, 2020 and international application number PCT / IL2020 / 050355, and which entered the national stage on November 24, 2021. The entire contents of the patent application are incorporated herein by reference. Technical Field

[0002] The present invention relates to the field of systems and methods for aiming a treatment tool, and more particularly, to systems and methods for aiming a treatment tool using an X-ray device or an ultrasound device. Background Art

[0003] Aiming the treatment tool at the target area and / or aligning the treatment tool relative to an imaging device (e.g., an X-ray device, an ultrasound device, etc.) typically requires a rigid mechanical connection between the treatment tool and the guiding imaging device, and at least one of an expensive and / or complex tracking unit capable of monitoring the relative position and / or orientation between the treatment tool and the imaging device at a relatively high update frequency (e.g., multiple times per second). Using X-ray imaging to track aiming and / or alignment of the treatment tool relative to, for example, an X-ray device may also require multiple exposures of the patient to X-ray radiation.

[0004] There is an unmet need for a system and method for aiming and / or aligning a therapeutic tool in the environment of an imaging device that reduces the cost and complexity of aiming and / or aligning compared to current procedures while eliminating the need for a rigid mechanical connection between the therapeutic tool and the imaging device. With respect to X-ray devices, there is an unmet need for a system and method for aiming and / or aligning a therapeutic tool in the environment of an X-ray device that reduces a patient's exposure to X-ray radiation compared to current procedures. Summary of the invention

[0005] Some embodiments may provide a system for aiming and aligning a treatment tool in an X-ray device environment, the system may include: a calibration plate, which can be attached to the X-ray device and includes at least one radiopaque marker and at least one optical marker at a predetermined position within the calibration plate; a camera, which can be attached to the treatment tool at a predetermined position and orientation relative to the treatment tool; and a processing unit, which communicates with the camera and an X-ray imaging unit of the X-ray device, the processing unit being configured to: receive an X-ray image including a visual representation of at least one radiopaque marker from the X-ray imaging unit; determine the position and orientation of the calibration plate relative to the X-ray device based on the visual representation of the at least one radiopaque marker in the X-ray image, the predetermined position of the at least one radiopaque marker within the calibration plate, and specified parameters of the X-ray device; receive a camera image including a visual representation of at least one optical marker from the camera; determine the position and orientation of the camera relative to the calibration plate based on the visual representation of the at least one optical marker in the camera image and the predetermined position of the at least one optical marker within the calibration plate; and determine the position and orientation of the treatment tool relative to the X-ray device based on the determined position and orientation of the calibration plate relative to the X-ray device, the determined position and orientation of the camera within the calibration plate, and the predetermined position and orientation of the camera relative to the treatment tool.

[0006] In some embodiments, the calibration plate may include at least one of: at least one asymmetric radiopaque marker; and a plurality of symmetric radiopaque markers that are asymmetrically positioned within the calibration plate.

[0007] In some embodiments, the system may include a display, and wherein the processing unit is configured to present a visual indicator on the display indicating the determined position and orientation of the treatment tool.

[0008] In some embodiments, the processing unit is configured to: determine whether the determined position and orientation of the treatment tool relative to the X-ray device is within an allowable error range compared to the required position and orientation of the treatment tool relative to the X-ray device; and modify the visual indicator to thereby indicate whether the position and orientation of the treatment tool is within its allowable error range.

[0009] In some embodiments, the processing unit is configured to superimpose a visual indicator on the X-ray image of the target area within the patient.

[0010] In some embodiments, the processing unit is configured to: detect or mark a target area in an X-ray image; determine whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the X-ray image; and modify a visual indicator to indicate whether the treatment tool is aligned relative to the target area.

[0011] In some embodiments, the processing unit is configured to: generate treatment tool guidance instructions based on the determined position and orientation of the treatment tool relative to the X-ray device; and display the treatment tool guidance instructions on the display.

[0012] In some embodiments, the treatment tool guidance instructions indicate one or more directions in which the treatment tool should be moved and a measure of movement in each of the one or more directions in order to bring the treatment tool into a position and orientation within its allowable error range.

[0013] In some embodiments, the processing unit is configured to display at least one of: treatment tool visual data, including a visual representation of at least a portion of the treatment tool; and system component visual data, including a visual representation of at least one component of the system and indicating the actual position and orientation of the corresponding at least one component relative to the treatment tool.

[0014] In some embodiments, the treatment tool is one of: a focused ultrasound transducer and an interventional treatment tool.

[0015] Some embodiments may provide a method for aiming and aligning a treatment tool in an X-ray device environment, the method may include: attaching a calibration plate to the X-ray device, wherein the calibration plate includes at least one radiopaque marker and at least one optical marker located at a predetermined position within the calibration plate; attaching a camera to the treatment tool at a predetermined position and orientation relative to the treatment tool; obtaining an X-ray image of the calibration plate through the X-ray device, wherein the X-ray image includes a visual representation of at least one radiopaque marker; determining, through a processing unit, the position and orientation of the calibration plate relative to the X-ray device based on the visual representation of at least one radiopaque marker in the X-ray image, the predetermined position of at least one radiopaque marker within the calibration plate, and specified parameters of the X-ray device; receiving, through the camera, a camera image including a visual representation of at least one optical marker; determining the position and orientation of the camera relative to the calibration plate based on the visual representation of at least one optical marker in the camera image and the predetermined position of at least one optical marker within the calibration plate; and determining the position and orientation of the treatment tool relative to the X-ray device based on the determined position and orientation of the calibration plate relative to the X-ray device, the determined position and orientation of the camera within the calibration plate, and the predetermined position and orientation of the camera relative to the treatment tool.

[0016] In some embodiments, the method may include displaying a visual indicator on a display indicating the determined position and orientation of the treatment tool.

[0017] In some embodiments, the method may include determining whether the determined position and orientation of the treatment tool relative to the X-ray device is within an allowable error range compared to the required position and orientation of the treatment tool relative to the X-ray device.

[0018] In some embodiments, the method may include modifying the visual indicator to thereby indicate whether the position and orientation of the treatment tool is within its allowed error range.

[0019] In some embodiments, the method may include superimposing a visual indicator on an X-ray image of the target area within the patient.

[0020] In some embodiments, the method may include: detecting or marking a target area in an X-ray image; determining whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the X-ray image; and modifying a visual indicator to indicate whether the treatment tool is aligned relative to the target area.

[0021] In some embodiments, the method may include: generating treatment tool guidance instructions based on the determined position and orientation of the treatment tool relative to the X-ray device; and displaying the treatment tool guidance instructions on a display.

[0022] In some embodiments, the treatment tool guidance instructions indicate one or more directions in which the treatment tool should be moved and a measure of movement in each of the one or more directions in order to bring the treatment tool into a position and orientation within its allowable error range.

[0023] In some embodiments, the method may include displaying at least one of: treatment tool visual data, including a visual representation of at least a portion of the treatment tool; and system component visual data, including a visual representation of at least one component of the system and indicating the actual position and orientation of the corresponding at least one component relative to the treatment tool.

[0024] In some embodiments, the method may include aiming and aligning the treatment tool according to a visual indicator displayed on a display without exposing the patient to X-ray imaging performed by an X-ray device.

[0025] Some embodiments may provide a system for aiming and aligning a treatment tool in an ultrasound imaging device environment, the system may include: a calibration plate that can be attached to an ultrasound imaging probe of the ultrasound imaging device and includes at least one optical marker at a predetermined position within the calibration plate; a camera that can be attached to the treatment tool at a predetermined position and orientation relative to the treatment tool; and a processing unit that communicates with the camera and the ultrasound imaging unit of the ultrasound imaging device, the processing unit being configured to: receive a camera image including a visual representation of at least one optical marker from the camera; determine a position and orientation of the camera relative to the calibration plate based on the visual representation of the at least one optical marker in the camera image and the predetermined position of the at least one optical marker within the calibration plate; and determine the position and orientation of the treatment tool relative to the ultrasound imaging probe based on the predetermined position and orientation of the calibration plate relative to the ultrasound imaging probe, the determined position and orientation of the camera relative to the calibration plate, and the known position and orientation of the camera relative to the treatment tool.

[0026] In some embodiments, the system may include a display, and wherein the processing unit is configured to present a visual indicator on the display indicating the determined position and orientation of the treatment tool.

[0027] In some embodiments, the processing unit is configured to: determine whether the determined position and orientation of the treatment tool relative to the ultrasound imaging probe is within an allowable error range compared to the required position and orientation of the treatment tool relative to the ultrasound imaging probe; and modify the visual indicator to thereby indicate whether the position and orientation of the treatment tool relative to the ultrasound imaging probe is within its allowable error range.

[0028] In some embodiments, the processing unit is configured to superimpose the visual indicator on the ultrasound image of the target area within the patient.

[0029] In some embodiments, the processing unit is configured to: detect or mark a target area in an ultrasound image; determine whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the ultrasound image; and modify a visual indicator to indicate whether the treatment tool is aligned relative to the target area.

[0030] In some embodiments, the processing unit is configured to: generate a treatment tool guidance instruction based on the determined position and orientation of the treatment tool relative to the ultrasound imaging probe; and display the treatment tool guidance instruction on the display.

[0031] In some embodiments, the treatment tool guidance instructions indicate one or more directions in which the treatment tool should be moved and a measure of movement in each of the one or more directions in order to bring the treatment tool into a position and orientation within its allowable error range.

[0032] In some embodiments, the processing unit is configured to display at least one of: treatment tool visual data, including a visual representation of at least a portion of the treatment tool; and system component visual data, including a visual representation of at least one component of the system and indicating the actual position and orientation of the corresponding at least one component relative to the treatment tool.

[0033] In some embodiments, the treatment tool is one of: a focused ultrasound transducer and an interventional treatment tool.

[0034] Some embodiments may provide a method for aiming and aligning a treatment tool in an ultrasound imaging device environment, the method may include: attaching a calibration plate to an ultrasound imaging probe of the ultrasound imaging device, wherein the calibration plate includes at least one optical mark located at a predetermined position within the calibration plate; attaching a camera to the treatment tool at a predetermined position and orientation relative to the treatment tool; obtaining, through the camera, a camera image including a visual representation of at least one optical mark; determining the position and orientation of the camera relative to the calibration plate based on the visual representation of at least one optical mark in the camera image and the predetermined position of at least one optical mark within the calibration plate; and determining the position and orientation of the treatment tool relative to the ultrasound imaging probe based on the determined position and orientation of the calibration plate relative to the ultrasound imaging probe, the determined position and orientation of the camera within the calibration plate, and the predetermined position and orientation of the camera relative to the treatment tool.

[0035] In some embodiments, the method may include displaying a visual indicator on a display indicating the determined position and orientation of the treatment tool.

[0036] In some embodiments, the method may include determining whether the determined position and orientation of the treatment tool relative to the ultrasound imaging probe is within an allowable error range compared to the required position and orientation of the treatment tool relative to the ultrasound imaging probe.

[0037] In some embodiments, the method may include modifying the visual indicator to indicate whether the position and orientation of the treatment tool relative to the ultrasound imaging probe is within its allowed error range.

[0038] In some embodiments, the method may include superimposing a visual indicator on an ultrasound image of a target area within the patient.

[0039] In some embodiments, the method may include: detecting or marking a target area in an ultrasound image; detecting or marking a target area in an ultrasound image; determining whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the ultrasound image; and modifying a visual indicator to indicate whether the treatment tool is aligned relative to the target area.

[0040] In some embodiments, the method may include: generating a treatment tool guidance instruction based on the determined position and orientation of the treatment tool relative to the ultrasound imaging probe; and displaying the treatment tool guidance instruction on a display.

[0041] In some embodiments, the treatment tool guidance instructions indicate one or more directions in which the treatment tool should be moved and a measure of movement in each of the one or more directions in order to bring the treatment tool into a position and orientation within its allowable error range.

[0042] In some embodiments, the method may include displaying at least one of: treatment tool visual data, including a visual representation of at least a portion of the treatment tool; and system component visual data, including a visual representation of at least one component of the system and indicating the actual position and orientation of the corresponding at least one component relative to the treatment tool.

[0043] In some embodiments, the method may include aiming and aligning the treatment tool according to visual indicators displayed on the display.

[0044] Some embodiments may provide a system for aiming and aligning a treatment tool in an X-ray device environment, the system may include: a calibration plate attachable to the treatment tool and including at least one optical marker at a predetermined position within the calibration plate; a camera attachable to the X-ray device; and a processing unit communicating with the camera and an X-ray imaging unit of the X-ray device, the processing unit being configured to: receive a camera image from the camera including a visual representation of at least one optical marker; determine a position and orientation of the calibration plate relative to the camera based on the visual representation of the at least one optical marker in the camera image and the predetermined position of the at least one optical marker within the calibration plate; and determine the position and orientation of the treatment tool relative to the X-ray device based on the determined position and orientation of the calibration plate relative to the camera and the position and orientation of the camera relative to the X-ray device.

[0045] In some embodiments, the position and orientation of the camera are known.

[0046] In some embodiments: the camera includes at least one radiopaque marker at least partially disposed within a field of view of an X-ray source of X-rays; and the processing unit is configured to: receive an X-ray image including a visual representation of the at least one radiopaque marker; and determine a position and orientation of the camera relative to the X-ray device based on the visual representation of the at least one radiopaque marker.

[0047] In some embodiments, the system may include a display, and wherein the processing unit is configured to present a visual indicator on the display indicating the determined position and orientation of the treatment tool.

[0048] In some embodiments, the processing unit is configured to: determine whether the determined position and orientation of the treatment tool relative to the X-ray device is within an allowable error range compared to the required position and orientation of the treatment tool relative to the X-ray device; and modify the visual indicator to thereby indicate whether the position and orientation of the treatment tool relative to the X-ray device is within its allowable error range.

[0049] In some embodiments, the processing unit is configured to superimpose a visual indicator on the X-ray image of the target area within the patient.

[0050] In some embodiments, the processing unit is configured to: detect or mark a target area in an X-ray image; determine whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the X-ray image; and modify a visual indicator to indicate whether the treatment tool is aligned relative to the target area.

[0051] In some embodiments, the processing unit is configured to: generate treatment tool guidance instructions based on the determined position and orientation of the treatment tool relative to the X-ray device; and display the treatment tool guidance instructions on the display.

[0052] In some embodiments, the treatment tool guidance instructions indicate one or more directions in which the treatment tool should be moved and a measure of movement in each of the one or more directions in order to bring the treatment tool into a position and orientation within its allowable error range.

[0053] In some embodiments, the processing unit is configured to display at least one of: treatment tool visual data, including a visual representation of at least a portion of the treatment tool; and system component visual data, including a visual representation of at least one component of the system and indicating the actual position and orientation of the corresponding at least one component relative to the treatment tool.

[0054] In some embodiments, the treatment tool is one of: a focused ultrasound transducer and an interventional treatment tool.

[0055] Some embodiments may provide a method for aiming and aligning a treatment tool in an X-ray device environment, the method may include: attaching a calibration plate to the treatment tool, wherein the calibration plate includes at least one optical mark located at a predetermined position within the calibration plate; mounting a camera on the X-ray device; obtaining, by the camera, a camera image including a visual representation of at least one optical mark; determining a position and orientation of the treatment tool relative to the camera based on the visual representation of the at least one optical mark in the camera image and the predetermined position of the at least one optical mark within the calibration plate; and determining the position and orientation of the treatment tool relative to the X-ray device based on the determined position and orientation of the calibration plate relative to the camera and the position and orientation of the camera relative to the X-ray device.

[0056] In some embodiments, the position and orientation of the camera are known.

[0057] In some embodiments, the method may include: attaching a camera to an X-ray device so that at least one of its radiopaque markers is at least partially disposed within a field of view of an X-ray source of the X-ray device; obtaining an X-ray image including a visual representation of at least one radiopaque marker; and determining a position and orientation of the camera relative to the X-ray device based on the visual representation of the at least one radiopaque marker.

[0058] In some embodiments, the method may include displaying a visual indicator on a display indicating the determined position and orientation of the treatment tool.

[0059] In some embodiments, the method may include determining whether the determined position and orientation of the treatment tool relative to the X-ray device is within an allowable error range compared to the required position and orientation of the treatment tool relative to the X-ray device.

[0060] In some embodiments, the method may include modifying the visual indicator to thereby indicate whether the position and orientation of the treatment tool relative to the X-ray device is within its allowed error range.

[0061] In some embodiments, the method may include superimposing a visual indicator on an X-ray image of a target area within the patient.

[0062] In some embodiments, the method may include: detecting or marking a target area in an X-ray image; determining whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the X-ray image; and modifying a visual indicator to indicate whether the treatment tool is aligned relative to the target area.

[0063] In some embodiments, the method may include: generating treatment tool guidance instructions based on the determined position and orientation of the treatment tool relative to the X-ray device; and displaying the treatment tool guidance instructions on a display.

[0064] In some embodiments, the treatment tool guidance instructions indicate one or more directions in which the treatment tool should be moved and a measure of movement in each of the one or more directions in order to bring the treatment tool into a position and orientation within its allowable error range.

[0065] In some embodiments, the method may display at least one of: treatment tool visual data, including a visual representation of at least a portion of the treatment tool; and system component visual data, including a visual representation of at least one component of the system and indicating the actual position and orientation of the corresponding at least one component relative to the treatment tool.

[0066] In some embodiments, the method may include aiming and aligning the treatment tool according to a visual indicator displayed on a display without exposing the patient to X-ray imaging performed by an X-ray device.

[0067] Some embodiments may provide a system for aiming and aligning a treatment tool in an ultrasound imaging device environment, the system may include: a calibration plate that can be attached to the treatment tool and includes at least one optical marker at a predetermined position within the calibration plate; a camera that can be attached to the ultrasound imaging probe at a predetermined position and orientation relative to the ultrasound imaging probe; and a processing unit that communicates with the camera and an ultrasound imaging unit of the ultrasound imaging device, the processing unit being configured to: receive a camera image from the camera that includes a visual representation of at least one optical marker; determine a position and orientation of the calibration plate relative to the camera based on the visual representation of the at least one optical marker in the camera image and the predetermined position of the at least one optical marker within the calibration plate; and determine the position and orientation of the treatment tool relative to the ultrasound imaging probe based on the predetermined position and orientation of the calibration plate relative to the treatment tool, the determined position and orientation of the calibration plate relative to the camera, and the known position and orientation of the camera relative to the ultrasound imaging probe.

[0068] In some embodiments, the system may include a display, and wherein the processing unit is configured to present a visual indicator on the display indicating the determined position and orientation of the treatment tool.

[0069] In some embodiments, the processing unit is configured to: determine whether the determined position and orientation of the treatment tool relative to the ultrasound imaging probe is within an allowable error range compared to the required position and orientation of the treatment tool relative to the ultrasound imaging probe; and modify the visual indicator to thereby indicate whether the position and orientation of the treatment tool relative to the ultrasound imaging probe is within its allowable error range.

[0070] In some embodiments, the processing unit is configured to superimpose the visual indicator on the ultrasound image of the target area within the patient.

[0071] In some embodiments, the processing unit is configured to: detect or mark a target area in an ultrasound image; determine whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the ultrasound image; and modify a visual indicator to indicate whether the treatment tool is aligned relative to the target area.

[0072] In some embodiments, the processing unit is configured to: generate a treatment tool guidance instruction based on the determined position and orientation of the treatment tool relative to the ultrasound imaging probe; and display the treatment tool guidance instruction on the display.

[0073] In some embodiments, the treatment tool guidance instructions indicate one or more directions in which the treatment tool should be moved and a measure of movement in each of the one or more directions in order to bring the treatment tool into a position and orientation within its allowable error range.

[0074] In some embodiments, the processing unit is configured to display at least one of: treatment tool visual data, including a visual representation of at least a portion of the treatment tool; and system component visual data, including a visual representation of at least one component of the system and indicating the actual position and orientation of the corresponding at least one component relative to the treatment tool.

[0075] In some embodiments, the treatment tool is one of: a focused ultrasound transducer and an interventional treatment tool.

[0076] Some embodiments may provide a method for aiming and aligning a treatment tool in an ultrasound imaging device environment, the method may include: attaching a calibration plate to the treatment tool, wherein the calibration plate includes at least one optical mark located at a predetermined position within the calibration plate; attaching a camera to an ultrasound imaging probe of the ultrasound imaging device at a predetermined position and orientation relative to the treatment tool; obtaining, through the camera, a camera image including a visual representation of at least one optical mark; determining the position and orientation of the calibration plate relative to the camera based on the visual representation of the at least one optical mark in the camera image and the predetermined position of the at least one optical mark within the calibration plate; and determining the position and orientation of the treatment tool relative to the ultrasound imaging probe based on the predetermined position and orientation of the calibration plate relative to the treatment tool, the determined position and orientation of the calibration plate relative to the camera, and the known position and orientation of the camera relative to the ultrasound imaging probe.

[0077] In some embodiments, the method may include displaying a visual indicator on a display indicating the determined position and orientation of the treatment tool.

[0078] In some embodiments, the method may include determining whether the determined position and orientation of the treatment tool relative to the ultrasound imaging probe is within an allowable error range compared to the required position and orientation of the treatment tool relative to the ultrasound imaging probe.

[0079] In some embodiments, the method may include modifying the visual indicator to indicate whether the position and orientation of the treatment tool relative to the ultrasound imaging probe is within its allowed error range.

[0080] In some embodiments, the method may include superimposing a visual indicator on an ultrasound image of a target area within the patient.

[0081] In some embodiments, the method may include: detecting or marking a target area in an ultrasound image; detecting or marking a target area in an ultrasound image; determining whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the ultrasound image; and modifying a visual indicator to indicate whether the treatment tool is aligned relative to the target area.

[0082] In some embodiments, the method may include: generating a treatment tool guidance instruction based on the determined position and orientation of the treatment tool relative to the ultrasound imaging probe; and displaying the treatment tool guidance instruction on a display.

[0083] In some embodiments, the treatment tool guidance instructions indicate one or more directions in which the treatment tool should be moved and a measure of movement in each of the one or more directions in order to bring the treatment tool into a position and orientation within its allowable error range.

[0084] In some embodiments, the method may include displaying at least one of: treatment tool visual data, including a visual representation of at least a portion of the treatment tool; and system component visual data, including a visual representation of at least one component of the system and indicating the actual position and orientation of the corresponding at least one component relative to the treatment tool.

[0085] In some embodiments, the method may include aiming and aligning the treatment tool according to visual indicators displayed on the display.

[0086] These, additional, and / or other aspects and / or advantages of the invention are set forth in the detailed description which follows; may be inferred from the detailed description; and / or may be learned by practice of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0087] For a better understanding of embodiments of the invention and to show how the invention may be carried into effect, reference will now be made, purely by way of example, to the accompanying drawings in which like numerals represent corresponding elements or parts.

[0088] In the attached picture:

[0089] Figure 1 is a schematic diagram of a first embodiment of a system for aiming and / or aligning a treatment tool in an X-ray device environment according to some embodiments of the present invention;

[0090] Figure 2A and Figure 2B is a schematic diagram of a calibration plate for a system for aiming and / or aligning a treatment tool in an X-ray device environment according to some embodiments of the present invention;

[0091] Figure 2Cis an image of a calibration plate for a system for aiming and / or aligning a treatment tool in an X-ray device environment according to some embodiments of the present invention;

[0092] Figure 3 is an X-ray image of a calibration plate of a system for aiming and / or aligning a treatment tool within an X-ray device environment according to some embodiments of the present invention;

[0093] Figure 4 is a camera image of a calibration plate of a system for aiming and / or aligning a treatment tool in an X-ray device environment according to some embodiments of the present invention.

[0094] Figure 5A , Figure 5B and Figure 5C is a schematic diagram of a system for aiming and / or aligning a treatment tool in an X-ray device environment according to some embodiments of the present invention, wherein the treatment tool requires alignment relative to the X-ray device;

[0095] Figure 5D is a schematic diagram of a system for aiming and / or aligning a treatment tool in an X-ray device environment according to some embodiments of the present invention, wherein the treatment tool has an X-ray aiming and alignment device;

[0096] Figure 5E and Fig. 5F is a schematic diagram of a visual representation of an X-ray aiming and alignment device for a treatment tool and a visual indicator generated by a processing unit of a system for aiming and / or aligning a treatment tool in an X-ray device environment according to some embodiments of the present invention;

[0097] Figure 5G A schematic diagram showing a system for aiming and / or aligning a treatment tool in an X-ray device environment and a flow chart of a method of using the system according to some embodiments of the present invention;

[0098] Figure 6 is a schematic diagram of a first embodiment of a system for delivering focused ultrasound energy according to some embodiments of the present invention;

[0099] Figure 7 is a flow chart of a first method of aiming and / or aligning a treatment tool in an X-ray device environment according to some embodiments of the present invention;

[0100] Figure 8 is a schematic diagram of a first embodiment of a system for aiming and / or aligning a treatment tool in an ultrasound imaging device environment according to some embodiments of the present invention;

[0101] Fig.9A and Fig. 9Bis a schematic diagram of a calibration plate for a system for aiming and / or aligning a treatment tool in an ultrasound imaging device environment according to some embodiments of the present invention;

[0102] Fig.10 is a camera image of a calibration plate of a system for aiming and / or aligning a treatment tool in an ultrasound imaging device environment according to some embodiments of the present invention;

[0103] Fig.11 is a schematic diagram of a second embodiment of a system for delivering focused ultrasound energy according to some embodiments of the present invention;

[0104] Fig.12 is a flow chart of a first method of aiming and / or aligning a treatment tool in an ultrasound imaging device environment according to some embodiments of the present invention;

[0105] Fig.13 is a schematic diagram of a calibration setup for a system for aiming and / or aligning a treatment tool in an ultrasound imaging device environment according to some embodiments of the present invention;

[0106] Fig.14A is a flow chart of a method of guiding aiming and / or alignment of a treatment tool in an imaging device environment according to some embodiments of the present invention; and

[0107] Fig. 14B is a schematic diagram of a guide feature for guiding aiming and / or alignment of a treatment tool in an imaging device environment according to some embodiments of the present invention;

[0108] Fig.15A and Fig. 15B is a schematic diagram of a second embodiment of a system for aiming and / or aligning a treatment tool in an X-ray device environment according to some embodiments of the present invention;

[0109] Fig.16 is a flow chart of a second method of aiming and / or aligning a treatment tool in an X-ray device environment according to some embodiments of the present invention;

[0110] Fig.17 is a schematic diagram of a second embodiment of a system for aiming and / or aligning a treatment tool in an ultrasound imaging device environment according to some embodiments of the present invention; and

[0111] Fig.18 is a flow chart of a second method of aiming and / or aligning a treatment tool in an ultrasound imaging device environment according to some embodiments of the present invention.

[0112] It should be understood that for simplicity and clarity of illustration, the elements shown in the figures are not necessarily drawn to scale. For example, for clarity, the size of some elements may be exaggerated relative to other elements. In addition, reference numerals may be repeated in the figures to indicate corresponding or similar elements where deemed appropriate. DETAILED DESCRIPTION

[0113] In the following description, various aspects of the present invention are described. For the purpose of illustration, specific configurations and details are set forth in order to provide a thorough understanding of the present invention. However, it is also apparent to those skilled in the art that the present invention may be implemented without the specific details set forth herein. In addition, well-known features may be omitted or simplified in order not to obscure the present invention. With specific reference to the accompanying drawings, it is emphasized that the details shown are intended only as examples and for illustrative discussion of the present invention, and are presented in order to provide what is considered to be the most useful and most easily understood description of the principles and conceptual aspects of the present invention. At this point, no attempt is made to illustrate the structural details of the present invention in more detail than is necessary for a basic understanding of the present invention, and the description in conjunction with the accompanying drawings enables those skilled in the art to understand how several forms of the present invention are implemented in practice.

[0114] Before explaining at least one embodiment of the present invention in detail, it should be understood that the application of the present invention is not limited to the details of the construction and arrangement of the parts described in the following description or shown in the accompanying drawings. The present invention is applicable to other embodiments and combinations of disclosed embodiments that can be practiced or executed in various ways. In addition, it should be understood that the phrases and terms used herein are for descriptive purposes and should not be considered as limiting.

[0115] Unless otherwise specifically stated, as will be apparent from the following discussion, it should be understood that throughout the specification, discussions using terms such as "processing," "calculating," "computing," "determining," "enhancing," etc. refer to the actions and / or processes of a computer or computing system or similar electronic computing device that operates and / or converts data represented as physical quantities, such as electronic quantities in registers and / or memories of a computing system, into other data similarly represented as physical quantities in the memory, registers, or other such information storage, transmission, or display devices of the computing system. Any of the disclosed modules or units may be implemented at least in part by a computer processor.

[0116] Reference now Figure 1 , which is a schematic diagram of a first embodiment of a system 100 for aiming and / or aligning a treatment tool 90 in an X-ray device 80 environment according to some embodiments of the present invention.

[0117] According to some embodiments, system 100 may include a calibration plate 110, a camera 120, and a processing unit 130 (e.g., Figure 1 shown). Figure 1 A side view of system 100 is shown. System 100 can enable treatment tool 90 to be aimed at target area 72 within patient 70 and / or align treatment tool 90 relative to x-ray device 80 while significantly reducing patient 70's exposure to x-ray radiation compared to a treatment procedure performed without system 100.

[0118] The X-ray device 80 may be any type of fluoroscopic device, such as a C-arm type, a G-arm type, or an O-arm type (e.g., a 9-inch, 12-inch flat panel device), and may include an X-ray intensifier 82, an X-ray source 83, an X-ray imaging unit 84, and an X-ray display 86 (e.g., Figure 1 shown).

[0119] The treatment tool 90 may be, for example, an invasive treatment tool (e.g., a needle (e.g., a biopsy needle, a radiofrequency needle) and / or a probe) or a non-invasive treatment tool (e.g., an ultrasound transducer or a focused ultrasound transducer) that requires aiming relative to the target area 72 and / or alignment relative to the X-ray device 80. For example, Figure 1 A needle is shown as an example of the treatment tool 90. In another example, FIG. 5A to FIG. 5G and Figure 6 A focused ultrasound transducer is shown as an example of a treatment tool 90 .

[0120] According to some embodiments, the calibration plate 110 may include at least one radiopaque marker 112 and at least one optical marker 114. The radiopaque marker 112 and the optical marker 114 may be positioned within the calibration plate 110 at predetermined and / or known locations (e.g., within the perimeter of the calibration plate, optionally on a surface thereof). The calibration plate 110 may be connectably or removably connected to the X-ray device 80 such that the calibration plate 110 will be in the field of view 83a of the X-ray source 83. For example, the calibration plate 110 may be connectably or removably connected to the X-ray intensifier 82 of the X-ray device 80. Referring to Figure 2A , Figure 2B and Figure 2C Various embodiments of the calibration plate 110 are described.

[0121] According to some embodiments, the camera 120 may be connectably or removably connected to the treatment tool 90. The camera 120 may be connected to the treatment tool 90 at a predetermined and / or known position and orientation relative to the treatment tool 90.

[0122] The camera 120 may be connected to the treatment tool 90 such that, for example, during the treatment process, at least a portion of the calibration plate 110 will be within the field of view 121 of the camera 120, and / or such that the camera 120 is outside (or substantially outside) the field of view 83a of the x-ray device 80 (e.g., such as Figure 1 shown).

[0123] In some embodiments, the system 100 may include a camera connector 122. The camera connector 122 may be configured to tightly and stably connect the camera 120 to the treatment tool 90 and prevent accidental relative movement of the camera 120 relative to the treatment tool 90. In some embodiments, the camera connector 122 may be made of a radiation-transparent material. In this way, the camera connector 122 does not interfere with the X-ray imaging performed by the X-ray device 80.

[0124] In some embodiments, the camera connector 122 can enable controlled rotation of the camera 120. For example, when the treatment tool 90 is moved, or when the C-arm of the X-ray device 80 is tilted 90 degrees, this can enable the camera 120 to follow the calibration plate 110 to capture a side view of the patient's anatomy.

[0125] In some embodiments, system 100 may include a second camera. The second camera may be tightly and stably attached to treatment tool 90 at a predetermined angle relative to camera 120 (e.g., using a connector similar to connector 122). For example, the second camera may be connected to treatment tool 90 at an angle of 90° relative to camera 120. For example, if calibration plate 110 leaves field of view 121 of camera 120, such as due to a 90 degree movement of the treatment tool or a 90 degree tilt of the C-arm for capturing a side view of the patient's anatomy, this may enable calibration plate 110 to be captured by the second camera.

[0126] According to some embodiments, the processing unit 130 may communicate (eg, wired or wirelessly) with the camera 120 and with the X-ray imaging unit 84 of the X-ray device 80 .

[0127] According to some embodiments, the processing unit 130 may be configured to receive one or more X-ray images of the calibration plate 110 from the X-ray imaging unit 84. The X-ray image of the calibration plate 110 may include a visual representation of the radiopaque markers 112 (e.g., as described below with respect to Figure 3 shown and described).

[0128] According to some embodiments, the processing unit 130 may be configured to determine the position and orientation of the calibration plate 110 relative to the X-ray device 80 based on the visual representation of the radiopaque marker 112, based on the known position of the radiopaque marker 112 within the calibration plate 110, and based on specified parameters or a specified model of the X-ray device 80. For example, the specified parameters / model of the X-ray device 80 may include a distance value from the X-ray source 83 to the X-ray intensifier 82 and a field of view size of the X-ray intensifier 82 (e.g., a metric size of an image pixel on the X-ray intensifier 82).

[0129] In some embodiments, the processing unit 130 may be configured to identify visual representations of the radiopaque markers 112 in an X-ray image of the calibration plate 110. Identification thereof may be exploited using, for example, a pattern matching algorithm.

[0130] In some embodiments, the processing unit 130 may be further configured to determine one or more vectors extending from the X-ray source 83 toward the X-ray intensifier 82 and the calibration plate 110 attached thereto and intersecting the calibration plate 110. For example, the vector may represent an X-ray generated by the X-ray source 83. The determination of the vector may be based on, for example, a specified model of the X-ray device 80.

[0131] In some embodiments, the processing unit 130 may be further configured to determine one or more intersection points of the corresponding one or more vectors with the calibration plate 110 .

[0132] In some embodiments, the processing unit 130 may be further configured to compare the predetermined / known position of the radiopaque marker 112 within the calibration plate 110 with the intersection of the determined vector and the calibration plate 110. The comparison may use, for example, a point cloud matching algorithm (e.g., a brute force algorithm or an iterative closest point algorithm).

[0133] In some embodiments, the processing unit 130 may be further configured to determine the position and orientation of the calibration plate 110 relative to the X-ray device 80 based on a comparison between the predetermined / known positions of the radiopaque markers 112 within the calibration plate 110 and the intersection of the determined vector with the calibration plate 110. This determination may be utilized using, for example, an alignment algorithm such as a singular value decomposition (SVD) algorithm.

[0134] According to some embodiments, processing unit 130 may be configured to receive one or more camera images of calibration plate 110 from camera 120. The camera image of calibration plate 110 may include a visual representation of optical markers 114 (e.g., as described below with respect to Figure 4 shown and described).

[0135] According to some embodiments, the processing unit 130 may be configured to determine the position and orientation of the camera 120 relative to the calibration plate 110 (which may be attached to, for example, the X-ray intensifier 82) based on the visual representation of the optical marker 114 in the camera image, based on the known position of the optical marker 114 within the calibration plate 110, and based on parameters of the camera 120 (e.g., such as distortion, field of view 121, etc.). This determination may be utilized using, for example, a bundle adjustment / PNP algorithm.

[0136] According to some embodiments, the processing unit 130 may be configured to determine the position and orientation of the treatment tool 90 relative to the X-ray device 80 based on the determined position and orientation of the calibration plate 110 relative to the X-ray device 80, the determined position and orientation of the camera 120 relative to the calibration plate 110, and the known position and orientation of the camera 120 relative to the treatment tool 90.

[0137] According to some embodiments, the system 100 may include a display 140. The processing unit 130 may be configured to present at least one visual indicator 142 indicating the determined position and orientation of the treatment tool 90 on the display 140 and / or the X-ray display 86, for example.

[0138] In some embodiments, the processing unit 130 may be configured to determine whether the determined position and orientation of the treatment tool 90 relative to the X-ray device 80 is within an allowable error range compared to the required position and orientation of the treatment tool 90 relative to the X-ray device 80. In some embodiments, the processing unit 130 may be configured to update the visual indicator 142 to indicate whether the position and orientation of the treatment tool 90 is within its allowable error range. The modification of the visual indicator 142 may, for example, include a change in the color and / or shape of the visual indicator 142 (e.g., according to a predetermined rule).

[0139] In various embodiments, the processing unit 130 may be configured to superimpose the visual indicator 142 on an X-ray image of, for example, the target area 72 of the patient 70 to generate an overlay image, and display the overlay image on the display 140 and / or the X-ray display 86 .

[0140] In some embodiments, the processing unit 130 may be configured to detect or mark the target area 72 in its X-ray image. In some embodiments, the marking may be based on user input. The processing unit 130 may be configured to determine whether the treatment tool 90 is aligned relative to the target area 72 based on the determined position and orientation of the treatment tool 90 and the X-ray image. In some embodiments, the processing unit 130 may be configured to update the visual indicator 142 to indicate whether the treatment tool 90 is aligned with the target area 72.

[0141] In some embodiments, the processing unit 130 may generate treatment tool guidance instructions based on the determined position and orientation of the treatment tool 90 relative to the X-ray device 80, and display the treatment tool guidance instructions on the display 86 / 140 (e.g., as described below with respect to Fig.14A and Fig. 14BThe guidance instructions may indicate one or more directions in which the treatment tool 90 should move (e.g., shift and / or tilt) and / or the measure of movement in each direction so as to bring the treatment tool 90 into a position and orientation within its allowable error range. The treatment tool guidance instructions, for example, may make it easy and intuitive to aim and / or align the treatment tool 90 relative to the target area 72 and / or the X-ray device 80.

[0142] The system 100 may enable a user (e.g., a treating physician) to aim the treatment tool 90 at the target area 72 and / or to align (e.g., translate, tilt, pitch, yaw, roll, etc.) the treatment tool 90 relative to the X-ray device 80 using a visual indicator 142 displayed on the display 140 and / or the X-ray display 86. The visual indicator 142 may indicate the position and orientation of the treatment tool 90 relative to the X-ray device 80, which eliminates (or substantially eliminates) the need for X-ray imaging of the patient 70 during aiming and / or alignment of the treatment tool 90. When the system 100 is used, X-ray imaging is only required at the final stage of aiming and / or alignment of the treatment tool 90 in order to verify that the actual position and orientation of the treatment tool 90 relative to the X-ray device 80 corresponds to its desired position and orientation or is within an allowable error range thereof before applying the treatment. In this way, the system 100 may significantly reduce the patient and / or user's exposure to X-ray radiation during treatment, compared to current treatment procedures that require the patient 70 to be exposed to X-ray radiation multiple times during aiming and / or alignment of the treatment tool 90.

[0143] refer to Figure 2A and Figure 2B , which are schematic illustrations of a calibration plate 200 that may be used to aim and / or align a treatment tool 90 (eg, system 100) within an X-ray device 80 environment, according to some embodiments of the present invention.

[0144] Also refer to Figure 2C , according to some embodiments of the present invention, this figure is an image of a calibration plate 200 that can be used in a system (e.g., system 100) for aiming and / or aligning a treatment tool 90 within the environment of an X-ray device 80.

[0145] According to some embodiments, the calibration plate 200 may be used to aim and / or align a system for the treatment tool 90 within the environment of the x-ray device 80 (e.g., such as described above with respect to Figure 1 For example, the calibration plate 200 may be the system 100 described above. Figure 1 A calibration plate 110 is described.

[0146] Figure 2A , Figure 2B and Figure 2CThe surface of the calibration plate 200 is shown marked with optical and / or radiopaque markings.

[0147] According to some embodiments, the calibration plate 200 may include at least one radiopaque marker 210 at a known location within the calibration plate 200 (e.g., Figure 2A ). The radiopaque marker 210 may be asymmetric with respect to at least one of its axes. For example, Figure 2A A single radiopaque marker 210 having an arrow shape (eg, asymmetric with respect to its horizontal axis) is shown. In some embodiments, the radiopaque marker 210 may be as described above with respect to Figure 1 A radiopaque marker 112 is depicted.

[0148] exist Figure 2A In the illustrated embodiment, the radiopaque marker 210 may have any asymmetric shape that can be used based on the visual representation of the radiopaque marker 210 in the X-ray image of the calibration plate 200 (e.g., as described above with respect to Figure 1 The method further comprises: determining / identifying the position and orientation of the calibration plate 200 (eg, relative to the X-ray device 80).

[0149] According to some embodiments, the calibration plate 200 may include a plurality of radiopaque markers 220 (e.g., Figure 2B and Figure 2C As shown). The radiopaque markers 220 can be symmetrical or asymmetrical (e.g., relative to at least one of their axes). For example, the radiopaque markers 220 can be spheres (e.g., symmetrical markers) or circular arrows (e.g., asymmetrical markers). The radiopaque markers 220 can be asymmetrically distributed within the calibration plate 220 (e.g., relative to at least one axis of the calibration plate 220). In some embodiments, the radiopaque markers 220 can be the above-mentioned Figure 1 A radiopaque marker 112 is depicted.

[0150] exist Figure 2B and Figure 2C In the illustrated embodiment, the positions of the radiopaque markers 220 within the calibration plate 200 may be predetermined so as to be able to be determined based on a visual representation of the radiopaque markers 220 in an X-ray image of the calibration plate 200 (e.g., as described above with respect to Figure 1 The method further comprises: determining / identifying the position and orientation of the calibration plate 200 (eg, relative to the X-ray device 80).

[0151] In some embodiments, a processing unit (e.g., Figure 1The processing unit 130 described above can be configured to detect and correct a rotation and / or flip of an X-ray image relative to a visual representation of the radiopaque marker 220 in a previous X-ray image of the calibration plate 200 based on the visual representation of the radiopaque marker 220 in the X-ray image of the calibration plate 200. In some embodiments, detection of rotation and / or flip of the X-ray image can be performed for each acquired X-ray image because the detection is fast in terms of computational time.

[0152] According to some embodiments, the calibration plate 200 includes a plurality of optical marks 230 (e.g., Figure 2A , Figure 2B and Figure 2C In some embodiments, the optical marker 230 may be Figure 1 An optical marker 114 is described.

[0153] In some embodiments, each of the optical markers 230 may include its unique visual label. The visual label of the optical marker 230 may include, for example, a barcode, a QR code, a graphic pattern or shape, Aruco, apriltag, ARtag, etc., which may carry additional data associated with the visual label. For example, the visual label may encode the location of the optical marker 230 within the calibration plate 200.

[0154] Parameters of the optical marker 230, such as the amount of the optical marker 230, the size of the optical marker 230, and / or the visual label of the optical marker 230, may be determined based on, for example, the resolution of the camera 120. The parameters of the optical marker 230 may be further determined to determine / identify the camera based on the visual representation of the optical marker 230 in the camera image of the calibration plate 200 (e.g., as described above with respect to Figure 1 The position and orientation of the camera 120) relative to the calibration plate 200 (e.g., as described above with respect to Figure 1 described above).

[0155] According to various embodiments, the calibration plate 200 may be made of a light-transmitting material and / or a rigid material. For example, the calibration plate 200 may be made of organic glass, cardboard, foam board, and / or an adhesive material. In this way, deformation of the calibration plate 200 may be prevented, thereby preventing the radiopaque markers 210, 220 and the optical marker 230 from moving from their predetermined positions.

[0156] In various embodiments, radiopaque markers (eg, radiopaque markers 210 and / or 220) may be embedded in or attached to a surface of calibration plate 200 (eg, as shown in FIG. Figure 2C In some embodiments, the optical mark 230 may be printed on the surface of the calibration plate 200 (e.g., as shown in FIG. Figure 2C shown).

[0157] In some embodiments, the calibration plate 200 may have a matte surface. For example, the matte surface of the calibration plate 200 may reduce light reflections from light sources in an operating room and eliminate (or substantially eliminate) glare in a camera image due to its light reflections, thereby avoiding loss of information obtained from the optical markers 230.

[0158] Reference now Figure 3 , which is an X-ray image 300 of a calibration plate (e.g., calibration plate 110 or 200) of a system for aiming and / or aligning a treatment tool 90 within an X-ray device 80 environment (e.g., system 100) according to some embodiments of the present invention.

[0159] Figure 3 Depicted are, for example, calibration plates (e.g. Figure 2C The X-ray image 300 may be obtained using the X-ray device 80 before or during the treatment process (e.g., as described above with respect to Figure 1 The X-ray image 300 includes a visual representation 310 of a radiopaque marker asymmetrically positioned at its predetermined location within the calibration plate (e.g., Figure 2C The radiopaque marker 220 depicted in FIG.

[0160] Reference now Figure 4 , which is a camera image 400 of a calibration plate (e.g., calibration plate 110 or 200) of a system (e.g., system 100) for aiming / aligning a treatment tool 90 within an X-ray device 80 environment according to some embodiments of the present invention.

[0161] For example, Figure 4 A calibration plate (e.g. Figure 2C For example, during a treatment procedure, a camera attached to the treatment tool 90 (e.g., as described above with respect to Figure 1 The camera image 400 may include optical markers (e.g., Figure 2C 4. A visual representation 410 of the optical marker 230 depicted in FIG.

[0162] Reference now Figure 5A , Figure 5B and Figure 5C , which are schematic diagrams of a system 500 for aiming and / or aligning a treatment tool 90 in an X-ray device 80 environment according to some embodiments of the present invention, wherein the treatment tool 90 requires alignment relative to the X-ray device 80.

[0163] In order to safely apply the treatment, some treatment tools 90 need to be aligned relative to the x-ray device 80. For example, the desired position and orientation of such treatment tools (e.g., as described above with respect to Figure 1 The desired position and orientation described herein may include alignment of a central longitudinal axis 90a of the treatment tool 90 with a central longitudinal axis 81 of the x-ray device 80 (e.g., an axis extending between the centers of the x-ray source 83 and the x-ray intensifier 82). Examples of such treatment tools 90 may include a focused ultrasound (FUS) transducer configured to project focused ultrasound energy 98 onto a target area 72 within a patient 70, such as a human patient or any other mammal, such as Figure 5A , Figure 5B and Figure 5C Schematically shown in FIG.

[0164] For example, Figure 5A The treatment tool 90 is shown aligned along its central longitudinal axis 90a with the central longitudinal axis 81 of the X-ray device 80 . Figure 5B and Figure 5C The treatment tool 90 is shown misaligned relative to the central longitudinal axis 81 of the X-ray device 80.

[0165] According to some embodiments, system 500 may include a calibration plate 510, a camera 520, and a processing unit 530 (e.g., Figure 5A For example, the system 500 may be such as described above with respect to Figure 1 A system 100 is described.

[0166] According to some embodiments, the calibration plate 510 may be attachable or removably attachable to the X-ray device 80 such that the calibration plate 510 will be in the field of view 83a of the X-ray source 83. For example, the calibration plate 510 may be an X-ray intensifier 82 that is attachable or removably attachable to the X-ray device 80.

[0167] For example, the calibration plate 510 may be the calibration plate 110 (described above with reference to FIG. Figure 1 Description) or calibration plate 200 (described above Figure 2A , Figure 2B and Figure 2C The radiopaque marker 512 may be the radiopaque marker 112 (described above). Figure 1 Description), radiopaque marker 210 (described above Figure 2A Description) or radiopaque marker 220 (described above with respect to Figure 2B and Figure 2C The optical marker 514 may be the optical marker 114 (described above). Figure 1 Description) or optical marker 230 (described above Figure 2A , Figure 2B and Figure 2Cdescribe).

[0168] According to some embodiments, the camera 520 may be attached or removably attached to the treatment tool 90 (e.g., using a camera connector 522) at a predetermined / known position and orientation relative to the treatment tool 90. For example, the camera 520 and the camera connector 522 may be the same as described above with respect to Figure 1 Cameras and connectors (eg, camera 120 and camera connector 122) are described.

[0169] According to some embodiments, the processing unit 530 may communicate (wired or wirelessly) with the X-ray imaging unit 84 and the camera 520. For example, the processing unit 530 may be the same as described above with respect to Figure 1 The processing unit 130 is described.

[0170] The processing unit 530 may be configured to determine the position and orientation of the treatment tool 90 relative to the X-ray device 80 (e.g., as described above with respect to Figure 1 described above).

[0171] In various embodiments, the processing unit 530 may be configured to determine whether the central longitudinal axis 90a of the treatment tool 90 is aligned / misaligned along the central longitudinal axis 81 of the X-ray device 80 and / or whether its misalignment is within an allowable error range (e.g., as described above with respect to FIG. 1 ) based on the determined position and orientation of the treatment tool 90 relative to the X-ray device 80. Figure 1 The permissible error range described).

[0172] According to various embodiments, the processing unit 530 may be configured to display, for example, on the display 540 and / or the X-ray display 86, a visual indicator 542 indicating the determined position and orientation of the treatment tool 90 relative to the X-ray device 80 (e.g., as described above with respect to FIG. Figure 1 The visual indicator 542 may be the Figure 1 The visual indicator 142 .

[0173] The visual indicator 542 may be further configured to indicate whether the central longitudinal axis 90a of the treatment tool 90 is aligned or misaligned along the central longitudinal axis 81 of the X-ray device 80 and / or whether the misalignment therebetween is within an allowable error range.

[0174] In some embodiments, the visual indicator 542 may include a first visual component 542a and a second visual component 542b (eg, Figure 5A , Figure 5B and Figure 5C). The first visual member 542a and the second visual mark 542b can have different shapes, sizes or other visual parameters (e.g., color, line width, etc.). For example, the first visual member 542a and the second visual member 542b can have any combination of circular marks (e.g., "O"), cross marks (e.g., "+"), etc.

[0175] For example, when the processing unit 530 determines that the central longitudinal axis 90a of the treatment tool 90 is aligned along the central longitudinal axis 81 of the X-ray device 80, the first visual component 542a and the second visual component 542b can coincide with each other when displayed on the display 540 and / or the X-ray display 86.

[0176] However, in this example, when the processing unit 530 determines that the central longitudinal axis 90a of the treatment tool 90 is misaligned relative to the central longitudinal axis 81 of the X-ray device 80, the first visual member 542a and the second visual member 542b do not overlap relative to each other when displayed on the display 540 and / or the X-ray display 86.

[0177] In some embodiments, the processing unit 530 may be configured to update visual parameters of the visual indicator 542 (or the first and second visual members 542a , 542b ) based on the determined position and orientation of the treatment tool 90 relative to the X-ray device 80 .

[0178] For example, when the central longitudinal axis 90a of the treatment tool 90 is aligned along the central longitudinal axis 81 of the X-ray device 80, or when the misalignment between the two is within the allowable error range, the visual indicator 542 may have, for example, a green color.

[0179] However, in this example, when the misalignment between the central longitudinal axis 90a of the treatment tool 90 and the central longitudinal axis 81 of the X-ray device 80 is not within the allowed error range, the visual indicator 542 may have, for example, a red color.

[0180] Figure 5A , Figure 5B and Figure 5C A non-limiting example of a first viewable member 542a and a second viewable member 542b having an annular shape is shown, wherein the diameter of the second viewable member 542b is smaller than the diameter of the first viewable member 542a.

[0181] In this example, when the processing unit 530 determines that the central longitudinal axis 90a of the treatment tool 90 is aligned along the central longitudinal axis 81 of the X-ray device 80, the first visual component 542a and the second visual component 542b may be coincident with respect to each other when displayed on the display 540 and / or the X-ray display 86 (e.g., as shown in FIG. 1 ). Figure 5A shown).

[0182] However, in this example, when the processing unit 530 determines that the central longitudinal axis 90a of the treatment tool 90 is misaligned with respect to the central longitudinal axis 81 of the X-ray device 80 and when the misalignment between the two is within the allowable error range, when displayed on the display 540 and / or the X-ray display 86, the second visual component 542b can be completely positioned within the first visual component 542a, but not coincident therewith (for example, as shown in FIG. Figure 5B shown).

[0183] However, in this example, when the processing unit 530 determines that the misalignment between the central longitudinal axis 90a of the treatment tool 90 and the central longitudinal axis 81 of the X-ray device 80 is not within the allowable error range, when displayed on the display 540 and / or the X-ray display 86 (e.g., as Figure 5C ), the second viewable member 542b may only partially overlap within the first viewable member 542a, or may not overlap at all.

[0184] Reference now Figure 5D , which is a schematic diagram of a system 500 for aiming and / or aligning a treatment tool 90 in an X-ray device 80 environment according to some embodiments of the present invention, wherein the treatment tool 90 has an X-ray aiming and alignment device 92.

[0185] Also refer to Figure 5E and Fig. 5F , which are schematic diagrams of a visual representation 85 of an X-ray aiming and alignment device 92 of a treatment tool 90 according to some embodiments of the present invention and a visual indicator 542 generated by a processing unit 530 of a system 500 for aiming and / or aligning the treatment tool 90 in an X-ray device 80 environment.

[0186] Some treatment tools (e.g., as described above with respect to X-ray device 80) may need to be aligned relative to X-ray device 80 before treatment is performed. Figure 5A , Figure 5B and Figure 5C The device may include an X-ray aiming and alignment device 92 (e.g., Figure 5D shown).

[0187] For example, the X-ray aiming and alignment device 92 may include two parallel, congruent, and radio-opaque surfaces positioned at a distance relative to each other along a central longitudinal axis 92c of the X-ray aiming and alignment device 92 (e.g., Figure 5D ) (e.g., first radiation opaque surface 92a and second radiation opaque surface 92b). The X-ray aiming and alignment device 92 can be attached to the treatment device 90 so that the central longitudinal axis 92c of the X-ray aiming and alignment device is aligned along the central longitudinal axis 90a of the treatment device 90.

[0188] The visual representation 85 in the X-ray image of the X-ray sighting and alignment device 92 (e.g., visual representation 85A of the first surface 92A and visual representation 85b of the second surface 92b) can provide an indication of whether the position and orientation of the treatment tool 90 relative to the X-ray device 80 is within an allowable error range compared to the desired position and orientation.

[0189] For example, when the position and orientation of the treatment tool 90 relative to the X-ray device 80 are within an allowable error range compared to its required position and orientation, the visual representation 85a of the first surface 92a may be consistent (or substantially consistent) with the visual representation 85b of the second surface 92b on the X-ray image of the X-ray aiming and alignment device 92 (e.g., displayed on, for example, the X-ray display 86) (e.g., as shown in FIG. Figure 5D shown).

[0190] In some embodiments, the processing unit 530 may generate a visual indicator 542 corresponding to the X-ray aiming and alignment device 92. For example, the first visual mark 542a and the second visual mark 542b of the visual indicator 542 may have the same (or substantially the same) shape and / or size as the visual representation 85a and the visual representation 85b of the first surface 92a and the second surface 92b of the X-ray aiming and alignment device 92, respectively (e.g., as shown in FIG. Figure 5D shown).

[0191] According to various embodiments, the processing unit 530 may be configured to display the display 540 (e.g., Figure 5D 540) and / or the X-ray display 86. In various embodiments, the processing unit 530 may be configured to display both the visual representation 85 of the X-ray aiming and alignment device 92 and the visual indicator 542 on the display 540 and / or the X-ray display 86 (e.g., as shown in FIG. Figure 5E and Fig. 5F shown).

[0192] In various embodiments, the processing unit 530 may be configured to superimpose the visual representation 85 of the X-ray aiming and / or alignment device 92 and the visual indicator 542 on the X-ray image of the target area 72 of the patient 70 displayed on the display 540 and / or the X-ray display 86.

[0193] In some embodiments, the processing unit 530 may be configured to detect or mark the target area 72 in its X-ray image. The processing unit 530 may be configured to determine whether the treatment tool 90 is aligned relative to the target area 72 based on the determined position and orientation of the treatment tool 90 and the X-ray image. In some embodiments, the processing unit 530 may be configured to update the visual indicator 542 to indicate whether the treatment tool 90 is aligned with the target area 72.

[0194] According to some embodiments, the determined position and orientation of the treatment tool 90 relative to the X-ray device 80 may differ from its actual position and orientation by a specified error value. The specified error value may depend on, for example, an error in the metric resolution of the X-ray intensifier 82, an error in the distance value between the X-ray source 83 and the X-ray intensifier 82, an incorrect connection of the calibration plate 510 to the X-ray intensifier 82 (e.g., such that the calibration plate 510 is not parallel to the X-ray intensifier 82), and / or an incorrect connection of the camera 520 to the treatment tool 90 (e.g., such that the camera 520 is not in a predetermined position and orientation relative to the treatment tool 90).

[0195] In some embodiments, the processing unit 530 can be configured to determine the position and orientation of the treatment tool 90 relative to the X-ray device 80 so that a specified error value does not exceed a millimeter.

[0196] When the determined position and orientation of the treatment tool 90 relative to the X-ray device 80 differs from its actual position and orientation, the visual indicator 542 may move relative to the visual representation 85 of the X-ray aiming and alignment device 92 (e.g., which represents its actual position and orientation)—e.g., as Fig. 5F As shown schematically in FIG.

[0197] In some embodiments, the processing unit 530 may be configured to update the determined position and orientation of the treatment tool 90 relative to the X-ray device 80 based on the visual representation 85 of the X-ray sighting and alignment device 92, thereby minimizing the error therebetween and generating an updated position and orientation of the treatment tool 90 relative to the X-ray device 80. The update may be utilized by, for example, identifying radiopaque markers (e.g., the first surface 92a and the second surface 92b) of the X-ray sighting and alignment device 92, and based on their positions, extrapolating the position of the treatment area 72 in the space between the X-ray source 83 and the X-ray intensifier 82 within its field of view 83a, and further superimposing the visual representation of the radiopaque markers on the X-ray image.

[0198] In some embodiments, the processing unit 530 may generate treatment tool guidance instructions based on the determined position and orientation of the treatment tool 90 relative to the X-ray device 80, and display the treatment tool guidance instructions on the display 86 / 540 (e.g., as described below with respect to Fig.14A and Fig. 14B The guidance instructions may indicate one or more directions in which the treatment tool 90 should move (e.g., shift and / or tilt) and / or the measure of movement in each direction so as to bring the treatment tool 90 into a position and orientation within its allowable error range. The treatment tool guidance instructions, for example, may make it easy and intuitive to aim and / or align the treatment tool 90 relative to the target area 72 and / or the X-ray device 80.

[0199] Note that processing may be applied based solely on the visual representation 85 of the X-ray targeting and alignment device 92 and the X-ray image of the target area 72 , without relying on the virtual indicator 542 .

[0200] Reference now Figure 5G , which shows a schematic diagram of a system 500 for aiming and / or aligning a treatment tool 90 in an X-ray device 80 environment according to some embodiments of the present invention and a flowchart of a method of using the system 500.

[0201] Note that this method is not limited to Figure 5G For example, in various embodiments, the method need not move through each illustrated box or stage, or in exactly the same order as illustrated and described.

[0202] For example, stage 590 of the method may include aiming the treatment tool 90 at the target area 72 within the patient 70 and / or based on indicating the determined position and orientation of the treatment tool 90 relative to the x-ray device 80 (e.g., as described above with respect to Figure 5A , Figure 5B , Figure 5C , Figure 5D , Figure 5E and Fig. 5F The visual indicator 542 (e.g., displayed on the display 540) of the treatment tool 90 aligns the treatment tool 90 relative to the x-ray device 80. For example, aiming and / or aligning can include translation, tilt, pitch, yaw, roll, etc. of the treatment tool 90.

[0203] Stage 590 of the method may be repeated until, for example, visual indicator 542 indicates that the position and orientation of treatment tool 90 relative to x-ray device 80 is within an allowable error range compared to its desired position and orientation (e.g., as described above with respect to Figure 5A , Figure 5B , Figure 5C , Figure 5D , Figure 5E and Fig. 5F described above).

[0204] Stage 590 of the method may be performed without obtaining an X-ray image of the treatment tool 90 / X-ray aiming and alignment device 92, for example based solely on the visual indicator 542 (e.g., as described above with respect to Figure 5A , Figure 5B , Figure 5C , Figure 5D , Figure 5E and Fig. 5FThis is in contrast to current treatment procedures which, for example, do not use system 500 and which require frequent X-ray imaging of treatment tool 90 and patient 70 during this stage of aiming and / or alignment.

[0205] Stage 592 of the method may include, for example, obtaining an X-ray image of an X-ray sighting and alignment device 92 of the treatment tool 90, and displaying a visual representation 85 of the X-ray sighting and alignment device 92, optionally together with a visual indicator 542, on, for example, a display 540 (e.g., as described above with respect to FIG. Figure 5A , Figure 5B , Figure 5C , Figure 5D , Figure 5E and Fig. 5F described above).

[0206] For example, stage 594 of the method may include determining whether the actual position and orientation of the treatment tool 90 is within an allowable error range relative to its desired position and orientation based on the visual representation 85 of the X-ray aiming and alignment device 92, e.g., as described above with respect to Figure 5A , Figure 5B , Figure 5C , Figure 5D , Figure 5E and Fig. 5F described.

[0207] If the actual position and orientation of the treatment tool 90 is within its allowed error range, the method can move to stage 596, which can, for example, include applying treatment via the treatment tool 90.

[0208] If the actual position and orientation of the treatment tool 90 is not within its allowed error range, the method may include repeating stage 590.

[0209] Reference now Figure 6 , which is a schematic diagram of a first embodiment of a system 600 for projecting focused ultrasound energy according to some embodiments of the present invention.

[0210] According to some embodiments, system 600 may include a focused ultrasound (FUS) transducer 610 arranged to generate FUS energy 619 (e.g., as described above with respect to FIG. 5A to FIG. 5G Treatment tool described 90).

[0211] According to some embodiments, the system 600 may include an X-ray aiming and alignment device 612 (e.g., as described above with respect to the FUS transducer 610) that may be attached to the FUS transducer 610. Figure 5D to Figure 5G X-ray aiming and alignment equipment 92 described).

[0212] According to some embodiments, the system 600 may include a stand 622 adapted to accommodate the FUS transducer 610. In some embodiments, the stand 622 may be hand-held. In some embodiments, the system 600 may include an articulated arm 622 coupled to the table 88 at a first end thereof to support the stand 620 at a second end thereof. The articulated arm 622 may be arranged to enable the stand 620 and the FUS transducer 610 accommodated therein to translate, tilt, pitch, yaw, and / or roll.

[0213] According to some embodiments, the system 600 may include an acoustic coupler 640 arranged to acoustically couple the FUS transducer 610 to the patient 70 , thereby enabling delivery of the FUS energy 619 to the target region 72 within the patient 70 .

[0214] According to some embodiments, the system 600 may include a calibration plate 650 that may be attached or removably attached to the X-ray device 80, such as the X-ray intensifier 82 (e.g., as described above with respect to Figure 1 The calibration plate 110 described above or FIG. 2A to FIG. 2C Calibration plate 200 described above).

[0215] According to some embodiments, the system 600 may include a camera 660 (e.g., as described above with respect to FIG. 1 ) that is removably connected to the support 620 / FUS transducer 610. Figure 1 The camera 120 described above or FIG. 5A to FIG. 5G Camera 520 described above).

[0216] According to some embodiments, the system 600 may include a processing unit 670 (e.g., Figure 1 The processing unit 130 described above or FIG. 5A to FIG. 5G The processing unit 670 may be configured to determine the position and orientation of the FUS transducer 610 relative to the X-ray device 80 (e.g., as described above with respect to FIG. 5A to FIG. 5G described above).

[0217] According to some embodiments, the system 600 may include a display 680. The processing unit 670 may be configured to display a visual indicator 682 (e.g., as described above with respect to the display 680 and / or the X-ray display 86) indicating the determined position and orientation of the FUS transducer 610. FIG. 5A to FIG. 5G 542).

[0218] In various embodiments, the processing unit 670 may be configured to superimpose the visual indicator 682 on an X-ray image of, for example, the target area 72 of the patient 70 to generate an overlay image, and display the overlay image on the display 680 and / or the X-ray display 86.

[0219] In some embodiments, the processing unit 670 may be configured to detect or mark the target area 72 in its X-ray image. The processing unit 130 may be configured to determine whether the treatment tool 90 is aligned relative to the target area 72 based on the determined position and orientation of the treatment tool 90 and the X-ray image. In some embodiments, the processing unit 130 may be configured to update the visual indicator 142 to indicate whether the treatment tool 90 is aligned with the target area 72.

[0220] In some embodiments, the processing unit 130 may generate treatment tool guidance instructions based on the determined position and orientation of the treatment tool 90 relative to the X-ray device 80, and display the treatment tool guidance instructions on the display 670 (for example, as described below with respect to Fig.14A and Fig. 14B The treatment tool guidance instructions may, for example, enable easy and intuitive aiming and / or alignment of the treatment tool 90 relative to the target area 72 and / or the X-ray device 80.

[0221] The system 600 may enable a user (e.g., a treating physician) to aim the FUS transducer 610 at a target area 72 within the patient 70 and / or to align the FUS transducer 610 relative to the X-ray device 80 using a visual indicator 682 displayed on the display 680 and / or the X-ray display 86. The visual indicator 682 may indicate a determined position and orientation of the FUS transducer 610 relative to the X-ray device 80, which eliminates (or substantially eliminates) the need for X-ray imaging of the patient 70 during aiming and / or alignment of the FUS transducer 610. When using the system 600, X-ray imaging is only required during the final stages of aiming and / or alignment of the FUS transducer 610, and the actual position and orientation of the FUS transducer 610 relative to the X-ray device 80 corresponds to its desired position and orientation or is within an allowable error range thereof (e.g., as described above with respect to FIG. 5A to FIG. 5G In this manner, the system 600 can significantly reduce the patient and / or user's exposure to X-ray radiation during treatment, compared to current treatment procedures that require the patient to be exposed to X-ray radiation more than 70 times during aiming and / or aligning the FUS transducer 610. In addition, the system 600 can significantly reduce the total duration of the treatment procedure compared to current treatment procedures that do not utilize the system 600.

[0222] Reference now Figure 7 , which is a flow chart of a first method of aiming and / or aligning a treatment tool in an X-ray device environment according to some embodiments of the present invention.

[0223] The method may be implemented by a system for aiming / aligning a treatment tool in an X-ray device environment (e.g., as described above with respect to Figure 1 The system 100 described above or FIG. 5A to FIG. 5G The system 500 described above can be implemented, which can be configured to implement the method. Note that the method is not limited to Figure 7 The flowcharts shown and the corresponding descriptions. For example, in various embodiments, the method need not move through each of the boxes or stages shown, or in exactly the same order as shown and described.

[0224] According to some embodiments, the method includes attaching (or removably attaching) a calibration plate to an X-ray intensifier of an X-ray device, wherein the calibration plate includes at least one radiopaque marker and at least one optical marker located at a predetermined position within the calibration plate (stage 702).

[0225] For example, the above Figure 1 Description of calibration plate 110, radiopaque marker 112 and optical marker 114 or above Figure 2A , Figure 2B and Figure 2C A calibration plate 200, a radiopaque marker 210 or 220, and an optical marker 230 are described.

[0226] Some embodiments may include attaching (or removably attaching) a camera to the treatment tool (stage 704) at a predetermined position and orientation relative to the treatment tool (e.g., as described above with respect to Figure 1 and FIG. 5A to FIG. 5G For example, the above Figure 1 The camera 120 described above or FIG. 5A to FIG. 5G Camera 520 is described.

[0227] Some embodiments may include obtaining an X-ray image of the calibration plate by an X-ray device, wherein the X-ray image includes a visual representation of at least one radiopaque marker (stage 706) (e.g., as described above with respect to Figure 1 and Figure 3 described above).

[0228] Some embodiments may include determining, by the processing unit, a position and orientation of the calibration plate relative to the X-ray device based on a visual representation of the at least one radiopaque marker in the X-ray image, a predetermined position of the at least one radiopaque marker within the calibration plate, and specified parameters of the X-ray device (stage 708) (e.g., as described above with respect to Figure 1 For example, the above Figure 1 The processing unit 130 described above or FIG. 5A to FIG. 5G The processing unit 530 is described.

[0229] Some embodiments may include identifying a visual representation of at least one radiopaque marker in an X-ray image of the calibration plate (stage 709). For example, by utilizing a pattern matching algorithm, as described above with respect to Figure 1 described.

[0230] Some embodiments may include determining, based on a specified model of the X-ray device, one or more vectors extending from an X-ray source of the X-ray device toward an X-ray intensifier and a calibration plate attached thereto and intersecting the calibration plate (stage 710) (e.g., as described above with respect to Figure 1 described above).

[0231] Some embodiments may include determining one or more intersection points of the corresponding one or more vectors with the calibration plate (stage 711) (e.g., as described above with respect to Figure 1 described above).

[0232] Some embodiments may include comparing a predetermined / known position of at least one radiopaque marker within the calibration plate to the determined vector and the intersection of the calibration plate (stage 712). For example, by utilizing the method described above with respect to Figure 1 The point cloud matching algorithm (eg, brute force algorithm or iterative closest point algorithm).

[0233] Some embodiments may include determining the position and orientation of the calibration plate relative to the x-ray device based on a comparison between the predetermined / known positions of the radiopaque markers within the calibration plate and the intersection of the determined vector with the calibration plate (stage 713). For example, by using the method described above with respect to Figure 1 The alignment algorithm described (such as, for example, a singular value decomposition (SVD) algorithm).

[0234] Some embodiments may include obtaining, via a camera, a camera image including a visual representation of at least one optical marker (stage 714) (e.g., as described above with respect to Figure 1 and Figure 4 described above).

[0235] Some embodiments may include determining a position and orientation of the camera relative to the calibration plate based on a visual representation of at least one optical marker in the camera image and a predetermined position of at least one optical marker within the calibration plate (stage 716) (e.g., as described above with respect to Figure 1 For example, by using Figure 1 The bundle adjustment / PnP algorithm described.

[0236] Some embodiments may include determining a position and orientation of the treatment tool relative to the X-ray device based on the determined position and orientation of the calibration plate relative to the X-ray device, the determined position and orientation of the camera relative to the calibration plate, and a predetermined position and orientation of the camera relative to the treatment tool (stage 718) (e.g., as described above with respect to Figure 1 and FIG. 5A to FIG. 5G described above).

[0237] Some embodiments may include displaying a visual indicator on a display indicating the determined position and orientation of the treatment tool (stage 720). Figure 1 The visual indicator 142 described above with respect to FIG. 5A to FIG. 5G Visual indicator 542 is described.

[0238] Some embodiments may include determining whether the determined position and orientation of the treatment tool relative to the x-ray device is within an allowable error range (e.g., as described above with respect to the position and orientation of the treatment tool relative to the x-ray device) compared to the required position and orientation of the treatment tool relative to the x-ray device (stage 722). Figure 1 and FIG. 5A to FIG. 5G described above).

[0239] Some embodiments may include updating the visual indicator to thereby indicate whether the position and orientation of the treatment tool relative to the x-ray device is within its allowed error range (stage 724) (e.g., as described above with respect to Figure 1 and FIG. 5A to FIG. 5G described above).

[0240] Some embodiments may include overlaying the visual indicator with the x-ray image of the target area of ​​the patient to produce an overlay image, and displaying the overlay image on a display (stage 725).

[0241] Some embodiments may include detecting or marking a target area in an X-ray image thereof, and determining whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the X-ray image (stage 726).

[0242] Some embodiments may include updating a visual indicator to indicate whether the treatment tool is aligned with the target area (stage 727).

[0243] Some embodiments may include generating and displaying on a display treatment tool guidance instructions indicating one or more directions in which treatment tool 90 should be moved (e.g., shifted and / or tilted) and / or a measure of movement in each direction in order to bring the treatment tool into a position and orientation within its tolerance range (stage 728). For example, as described below with respect to Fig.14A and Fig. 14B The treatment tool guidance instructions can be determined based on the determined position and orientation of the treatment tool relative to the X-ray device. The treatment tool guidance instructions can, for example, make it easy and intuitive to aim and / or align the treatment tool 90 relative to the target area and / or the X-ray device.

[0244] Some embodiments may include aiming and aligning the treatment tool according to visual indicators displayed on the display without exposing the patient to X-ray imaging of the X-ray device (stage 729) (e.g., as described above with respect to Figure 1 and FIG. 5A to FIG. 5G ).

[0245] Reference now Figure 8 , which is a schematic diagram of a first embodiment of a system 800 for aiming and / or aligning a treatment tool 90 in an ultrasound imaging device 60 environment according to some embodiments of the present invention.

[0246] According to some embodiments, system 800 may include a calibration plate 810 , a camera 820 , and a processing unit 830 . Figure 8 A side view of the system 800 is shown. The system 800 can align the treatment tool 90 with respect to the target area 72 within the patient 70 and / or align the treatment tool 90 with respect to the ultrasound imaging probe 62.

[0247] The ultrasound imaging device 60 may be any type of ultrasound imaging device, such as a handheld device, a laptop device, a probe connected to a cell phone or tablet computer, or a system on a portable cart, and may include one or more probes and other accessories.

[0248] The treatment tool 90 may be, for example, an invasive treatment tool (e.g., a needle (e.g., a biopsy needle, a radiofrequency needle) and / or a probe) or a non-invasive treatment tool (e.g., an ultrasound transducer or a focused ultrasound transducer) that requires aiming relative to the target area 72 and / or alignment relative to the ultrasound imaging probe 62. For example, Figure 8 A needle is shown as an example of the treatment tool 90 .

[0249] According to some embodiments, the calibration plate 810 may include at least one optical marker. The optical marker may be positioned at a predetermined and / or known position within the calibration plate 810. The calibration plate 810 may be connectable or removably connectable to the ultrasound imaging probe 62 of the ultrasound imaging device 60. Fig.9A and Fig. 9B Various embodiments of calibration plate 810 are described.

[0250] According to some embodiments, the camera 820 may be connectable or removably connectable to the treatment tool 90. The camera 820 may be attached to the treatment tool 90 at a predetermined and / or known position and orientation relative to the treatment tool 90.

[0251] The camera 820 may be attached to the treatment tool 90 such that at least a portion of the calibration plate 810 will be within the field of view 821 of the camera 820 .

[0252] In some embodiments, the system 800 may include a camera connector 822. The camera connector 822 may be configured to tightly and stably attach the camera 820 to the treatment tool 90 and prevent accidental relative movement of the camera 820 relative to the treatment tool 90.

[0253] In some embodiments, the camera connector 822 may enable controlled rotation of the camera 820, which may enable the camera 820 to follow the calibration plate 810 as the treatment tool 90 moves, for example.

[0254] In some embodiments, the system 800 may include a second camera. The second camera may be tightly and stably attached to the treatment tool 90 at a predetermined angle relative to the camera 820 (e.g., using a connector similar to the connector 822). For example, the second camera may be connected to the treatment tool 90 at an angle of 90° relative to the camera 820. For example, if the calibration plate 810 leaves the field of view 821 of the camera 820, for example due to movement of the treatment tool 90, this may be captured by the second camera.

[0255] According to some embodiments, the processing unit 830 may communicate (eg, wired or wirelessly) with the camera 820 and with the ultrasound imaging unit 64 of the ultrasound imaging device 60 .

[0256] According to some embodiments, processing unit 830 may be configured to receive one or more camera images of calibration plate 810 from camera 820. The camera images of calibration plate 810 may include visual representations of optical markers (e.g., as described below with respect to Fig.9A and Fig. 9B shown and described).

[0257] According to some embodiments, the processing unit 830 may be configured to determine the position and orientation of the camera 820 relative to the calibration plate 810 (e.g., which may be attached to the ultrasound imaging probe 62) based on the visual representation of the optical markers in the camera image, based on the known positions of the optical markers within the calibration plate 810, and based on parameters of the camera 820 (e.g., such as distortion, field of view 821, etc.). This determination may be utilized using, for example, a beam adjustment / PNP algorithm.

[0258] According to some embodiments, the processing unit 830 may be configured to determine the position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62 based on a predetermined position and orientation of the calibration plate 810 relative to the ultrasound imaging probe 62, a determined position and orientation of the camera 820 relative to the calibration plate 810, and a known position and orientation of the camera 820 relative to the treatment tool 90.

[0259] According to some embodiments, the system 800 may include a display 840. The processing unit 830 may be configured to present at least one visual indicator 842 indicating the determined position and orientation of the treatment tool 90 on the display 840 and / or the ultrasound display 66, for example.

[0260] In some embodiments, the processing unit 830 may be configured to determine whether the determined position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62 is within an allowable error range compared to the required position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62. The processing unit 830 may be configured to modify the visual indicator 842 to indicate whether the position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62 is within its allowable error range.

[0261] In various embodiments, the processing unit 830 may be configured to superimpose the visual indicator 842 on an ultrasound image of, for example, the target area 72 of the patient 70 to generate an overlay image and display the overlay image on the display 840 and / or the ultrasound display 66 .

[0262] In some embodiments, the processing unit 830 may be configured to detect or mark the target area 72 in its ultrasound image. In some embodiments, the marking may be based on a user's input. The processing unit 830 may be configured to determine whether the treatment tool 90 is aligned relative to the target area 72 based on the determined position and orientation of the treatment tool 90 and the ultrasound image. In some embodiments, the processing unit 830 may be configured to update the visual indicator 142 to indicate whether the treatment tool 90 is aligned with the target area 72.

[0263] In some embodiments, the processing unit 830 may generate treatment tool guidance instructions based on the determined position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62, and display the treatment tool guidance instructions on the display 86 / 840 (for example, as described below with respect to Fig.14A and Fig. 14B The treatment tool guidance instructions may indicate one or more directions in which the treatment tool 90 should be moved (e.g., shifted and / or tilted) and / or the measure of movement in each direction so as to bring the treatment tool 90 into a position and orientation that is within its allowed error range and / or aligned with respect to the target area 72. The treatment tool guidance instructions may, for example, make it easy and intuitive to aim and / or align the treatment tool 90 with respect to the target area 72 and / or the ultrasound imaging probe 62.

[0264] The system 800 can enable a user (e.g., a treating physician) to aim the treatment tool 90 at the target area 72 and / or align the treatment tool 90 relative to the ultrasound imaging probe 62 (e.g., translation, tilt, pitch, yaw, roll, etc.) using a visual indicator 842 displayed on the display 840 and / or ultrasound display 66. The visual indicator 842 can indicate the position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62, which eliminates (or substantially eliminates) the need for ultrasound imaging of the treatment tool tip. When using the system 800, ultrasound imaging of the treatment tool tip is only required (where applicable) in the final stages of aiming and / or aligning the treatment tool 90 to verify that the actual position and orientation of the treatment tool 90 relative to the patient's anatomy is correct before applying the treatment. In this way, the system 800 can significantly reduce procedure time compared to current treatment procedures.

[0265] refer to Fig.9A and Fig. 9B , which is a schematic diagram of a calibration plate 900 of a system (e.g., system 800) for aiming and / or aligning a treatment tool 90 in an ultrasound imaging device environment according to some embodiments of the present invention.

[0266] According to some embodiments, the calibration plate 900 includes a plurality of optical marks 930 (e.g., Fig.9A and Fig. 9B shown).

[0267] In some embodiments, each of the optical markers 930 may include its unique visual label. The visual label of the optical marker 930 may include, for example, a barcode, a QR code, a graphic pattern or shape, Aruco, apriltag, ARtag, etc., which may carry additional data associated with the visual label. For example, the visual label may encode the location of the optical marker 930 within the calibration plate 900.

[0268] Parameters of the optical markers 930, such as the number of optical markers 930, the size of the optical markers 930, and / or the visible label of the optical markers 930 can be determined based on, for example, the resolution of the camera (e.g., as described above with respect to Figure 8 The parameters of the optical marker 930 may be further determined to enable determination / identification of the camera (e.g., as described above with respect to the optical marker 930) based on the visual representation of the optical marker 930 in the camera image of the calibration plate 900. Figure 8 The position and orientation of the camera 820) relative to the calibration plate 900 (e.g., as described above with respect to Figure 8 described above).

[0269] In some embodiments, calibration plate 900 may have a matte surface. For example, the matte surface of calibration plate 900 may reduce light reflections from light sources in an operating room and eliminate (or substantially eliminate) glare in a camera image due to its light reflections, thereby avoiding loss of information obtained from optical markers 930.

[0270] Reference now Fig.10 , which is a camera image 1000 of a calibration plate (e.g., calibration plate 810 or 900) of a system (e.g., system 800) for aiming / aligning treatment tool 90 in an ultrasound imaging device environment according to some embodiments of the present invention.

[0271] For example, Fig.10 A calibration plate (e.g., Fig. 9B For example, during a treatment procedure, a camera attached to the treatment tool 90 (e.g., a calibration plate 900 shown in FIG. 1 ) may be used to provide a camera image 1000 of the treatment tool 90. Figure 8 The camera image 1000 may include an optical marker (e.g., Fig. 9B A visual representation 1010 of the optical marker 930 depicted in FIG.

[0272] Reference now Fig.11 , which is a schematic diagram of a second embodiment of a system 1100 for projecting focused ultrasound energy according to some embodiments of the present invention.

[0273] According to some embodiments, system 1100 may include a focused ultrasound (FUS) transducer 1110 arranged to generate FUS energy 1119 .

[0274] According to some embodiments, system 1100 may include an ultrasound imaging probe 62 .

[0275] According to some embodiments, the system 1100 may include a stand 1120 adapted to accommodate the FUS transducer 1110. In some embodiments, the stand 1120 may be hand-held. In some embodiments, the system 1100 may include an articulated arm 1122 coupled to the table 88 at a first end thereof to support the stand 1120 at a second end thereof. The articulated arm 1122 may be arranged to enable the stand 1120 and the FUS transducer 1110 accommodated therein to translate, tilt, pitch, yaw, and / or roll.

[0276] According to some embodiments, system 1100 may include an acoustic coupler 1140 arranged to acoustically couple FUS transducer 1110 to patient 70 , thereby enabling delivery of FUS energy 1119 to a target region 72 within patient 70 .

[0277] According to some embodiments, the system 1100 may include a calibration plate 1150 (e.g., as described above with respect to the calibration plate 1150) that is removably attached to the ultrasound imaging probe 62. Figure 8 The calibration plate 810 described above or FIG. 9A to FIG. 9B Calibration plate 900 described above).

[0278] According to some embodiments, the system 1100 may include a camera 1160 (e.g., as described above with respect to FIG. 1 ) that is removably connected to the support 1120 or the FUS transducer 1110. Figure 8 Camera 820 described above).

[0279] According to some embodiments, the system 1100 may include a processing unit 1170 (e.g., Figure 8 The processing unit 1170 may be configured to determine the position and orientation of the FUS transducer 1110 relative to the ultrasound imaging probe 62.

[0280] According to some embodiments, the system 1100 may include a display 1180 . The processing unit 1170 may be configured to display a visual indicator 1142 indicating the determined position and orientation of the FUS transducer 1110 on the display 1180 and / or the ultrasound display 66 .

[0281] In some embodiments, the processing unit 1170 may be configured to determine whether the determined position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62 is within an allowable error range compared to the desired position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62. The processing unit 1170 may be configured to modify the visual indicator 842 to indicate whether the position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62 is within its allowable error range.

[0282] In various embodiments, the processing unit 1170 may be configured to superimpose the visual indicator 1142 on an ultrasound image of, for example, the target area 72 of the patient 70 to generate an overlay image and display the overlay image on the display 1180 and / or the ultrasound display 66 .

[0283] In some embodiments, the processing unit 1170 may be configured to detect or mark the target area 72 in its ultrasound image. The processing unit 1170 may be configured to determine whether the treatment tool 90 is aligned relative to the target area 72 based on the determined position and orientation of the treatment tool 90 and the ultrasound image. In some embodiments, the processing unit 1170 may be configured to update the visual indicator 1142 to thereby indicate whether the treatment tool 90 is aligned with the target area 72.

[0284] In some embodiments, the processing unit 1170 may generate treatment tool guidance instructions and display the treatment tool guidance instructions on the display 86 / 1180 (e.g., as described below with respect to Fig.14A and Fig. 14B The treatment tool guidance instructions may be based on the position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62 (e.g., as described below with respect to Fig.14A and Fig. 14B For example, the treatment tool guidance instructions can make the treatment tool 90 easy and intuitive to aim and / or align with respect to the target area 72 and / or the ultrasound imaging probe 62.

[0285] The system 1100 may enable a user (e.g., a treating physician) to align the FUS transducer 1110 with a target area 72 within the patient 70 and / or with respect to the ultrasound imaging probe 62 using the display 1180 and / or visual indicators 1142 displayed on the ultrasound display 66. The visual indicators 1142 may indicate the determined position and orientation of the FUS transducer 1110 with respect to the ultrasound imaging probe 62. In this manner, the system 1100 may significantly reduce the overall duration of a treatment procedure as compared to current treatment procedures that do not utilize the system 1100.

[0286] Reference now Fig.12 , which is a flow chart of a first method of aiming and / or aligning a treatment tool in an ultrasound imaging device environment according to some embodiments of the present invention.

[0287] The method may be provided by a system for aiming / aligning a treatment tool in an ultrasound imaging device environment (e.g., as described above with respect to Figure 8 The system 800 described above with respect to Fig.11 The system 1100 described above can be implemented, which can be configured to implement the method. Note that the method is not limited to Fig.12 For example, in various embodiments, the method need not move through each illustrated box or stage, or in exactly the same order as illustrated and described.

[0288] According to some embodiments, the method includes attaching (or removably attaching) a calibration plate to an ultrasound imaging probe of an ultrasound imaging device, wherein the calibration plate includes at least one optical marker located at a predetermined position within the calibration plate (stage 1202).

[0289] For example, the above Figure 8 The calibration plate 810 described above or Fig.9A and Fig. 9B Calibration plate 900 and optical marker 930 are depicted.

[0290] Some embodiments may include attaching (or removably attaching) a camera to the treatment tool (stage 1204) at a predetermined position and orientation relative to the treatment tool (e.g., as described above with respect to Figure 8 For example, the above Figure 8 Camera 820 is described.

[0291] Some embodiments may include obtaining, via a camera, a camera image including a visual representation of at least one optical marker (stage 1206) (e.g., as described above with respect to Figure 8 and Fig.11 described above).

[0292] Some embodiments may include determining a position and orientation of the camera relative to the calibration plate based on a visual representation of at least one optical marker in the camera image and a predetermined position of at least one optical marker within the calibration plate (stage 1208) (e.g., as described above with respect to Figure 8 For example, by using Figure 8 The bundle adjustment / PnP algorithm described.

[0293] Some embodiments may include determining a predetermined position and orientation of the camera relative to the ultrasound imaging probe based on a predetermined position and orientation of the calibration plate relative to the ultrasound imaging probe, a determined position and orientation of the camera relative to the calibration plate, and a predetermined position and orientation of the camera relative to the treatment tool (stage 1210) (e.g., as described above with respect to Figure 8 The method can be used to determine the position and orientation of the treatment tool relative to the ultrasound imaging probe.

[0294] Some embodiments may include displaying a visual indicator on a display indicating the determined position and orientation of the treatment tool relative to the ultrasound imaging probe (stage 1212). Figure 8 Visual indicator 842 of the description.

[0295] Some embodiments may include determining whether the determined position and orientation of the treatment tool relative to the ultrasound imaging probe is within an allowable error range compared to the required position and orientation of the treatment tool relative to the ultrasound imaging probe (stage 1213). For example, this may allow the treatment tool to be quickly and accurately aimed at the target area.

[0296] Some embodiments may include modifying the visual indicator to thereby indicate whether the position and orientation of the treatment tool relative to the ultrasound imaging probe is within its allowed error range (stage 1214).

[0297] Some embodiments may include overlaying the visual indicator with the ultrasound image of the target area of ​​the patient to produce an overlay image, and displaying the overlay image on a display (stage 1215).

[0298] Some embodiments may include detecting or marking a target area in an ultrasound image thereof, and determining whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the ultrasound image (stage 1216).

[0299] Some embodiments may include updating a visual indicator to indicate whether the treatment tool is aligned with the target area (stage 1217).

[0300] Some embodiments may include generating and displaying on a display treatment tool guidance instructions indicating one or more directions in which the treatment tool should be moved (e.g., shifted and / or tilted) and / or a measure of movement in each direction in order to bring the treatment tool into a position and orientation within an allowable error range (stage 1218). For example, as described below with respect to Fig.14A and Fig. 14B This may, for example, allow a therapeutic tool to be quickly and accurately aimed at a target area.

[0301] Some embodiments may include aiming and / or aligning the treatment tool based on at least one visual indicator displayed on the display (stage 1219).

[0302] Reference now Fig.13 , which is a schematic diagram of a calibration setup 1300 for a system (such as systems 800 and 1100 described above) for aiming and / or aligning a treatment tool using an ultrasound imaging device according to some embodiments of the present invention.

[0303] The calibration device 1300 can be used to calibrate a system for aiming and / or aligning a treatment tool in an ultrasound imaging device environment (e.g., the systems 800 and 1100 described above). For example, the calibration device 1300 can be used to determine the position and orientation of a calibration plate 1324 (e.g., calibration plates 810, 900, 1000, or 1150 as described above) relative to an ultrasound imaging probe 62 (e.g., after the calibration plate 1324 is attached to the ultrasound imaging probe 62). If the calibration plate 1324 is permanently attached to the ultrasound probe 62, the calibration can be performed only once, such as at the factory, or the calibration can be repeated each time the calibration plate 1324 is removably attached to the ultrasound probe 62.

[0304] The calibration device 1300 may include one or more imaging targets 1304 embedded in an acoustically transparent medium 1302 (e.g., ultrasound gel, water). In some embodiments, the position of the imaging target 1304 may be known. The ultrasound imaging probe 62 may be set at a known imaging probe position and orientation relative to the imaging target 1304. The calibration plate 1324 may be connected or removably connected to the ultrasound imaging probe 62. The camera 1311 (e.g., such as the camera 820 or 1160 described above) may be set at a known camera position and orientation relative to the imaging target 1304 so that the calibration plate 1324 will be at least partially in its field of view 1312.

[0305] The ultrasound imaging probe 62 may obtain at least one ultrasound image of the imaging target 1304. The camera 1311 may obtain at least one camera image calibration plate 1324 attached to the ultrasound imaging probe 62. A processing unit (e.g., such as the processing units 830, 1170 described above) may receive an ultrasound image of the imaging target 1304 and a camera image 1324 of the calibration plate 1324. The processing unit may determine calibration data based at least on the ultrasound image and the camera image. For example, the calibration data may include a position and orientation of the calibration plate 1324 relative to the ultrasound imaging probe 62. The processing unit may determine the position and orientation of the calibration plate 1324 relative to the ultrasound imaging probe 62 based on the ultrasound image, the camera image, the known position of the imaging target 1304, the known imaging probe position and orientation, and the known camera position and orientation.

[0306] The calibration data may be stored and used for further processing. For example, the calibration data may be loaded into the processing unit 830 or the processing unit 1170 described above and used by the processing unit 830, 1170 to determine the position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62 (e.g., as described above with respect to FIG. Figure 8 described).

[0307] Reference now Fig.14A , which is a flow chart of a method of guiding aiming and / or alignment of a treatment tool in an imaging device environment according to some embodiments of the present invention.

[0308] The method may be performed, for example, by a processing unit of a system for aiming and / or aligning a treatment tool in an imaging device environment, for example with respect to Figure 1 , FIG. 5A to FIG. 5D , Figure 6 , Figure 8 and Fig.11 The systems 100, 500, 600, 500 and 1100 are described.

[0309] Also refer to Fig. 14B, which is a schematic diagram of guidance features for guiding aiming and / or alignment of a treatment tool in an imaging device environment, according to some embodiments of the present invention, according to some embodiments of the present invention.

[0310] According to some embodiments, the method may include presenting, by processing unit 1410 , at least one visual indicator 1420 on display 1430 (stage 1402 ).

[0311] In various embodiments, the visual indicator 1420 may indicate the actual position and orientation of the treatment tool relative to the imaging device (e.g., as described above with respect to FIG. 5D to FIG. 5F The visual representation 85 of the X-ray aiming and alignment tool 92 described above) and / or the determined position and orientation of the treatment tool relative to the imaging device (e.g., as described above with respect to Figure 1 , FIG. 5A to FIG. 5D , Figure 6 , Figure 8 and Fig.11 The visual indicator 1420 may also indicate whether the position and orientation of the treatment tool relative to the imaging device is within its allowable error range. For example, this may allow the treatment tool to be quickly and accurately aimed at the target area. In some embodiments, the visual indicator 1420 may be superimposed on an image obtained or being obtained by the imaging device (e.g., as described above with respect to Figure 1 , FIG. 5A to FIG. 5D , Figure 8 ).

[0312] According to some embodiments, the method may include generating, by the processing unit 1410 , treatment tool guidance instructions 1440 based on the determined position and orientation of the treatment tool relative to the imaging device (stage 1404 ).

[0313] According to some embodiments, the method may include presenting, by processing unit 1410, treatment tool guidance instructions 1440 on display 1430 (stage 1406). For example, treatment tool guidance instructions 1440 may enable easy and intuitive aiming and / or alignment of a treatment tool relative to a target area and / or imaging device.

[0314] The treatment tool guidance instructions 1440 may be displayed, for example, in a designated area 1432 on the display 1430. For example, the designated area 1432 may be selected by the processing unit 1410 so as not to obstruct any important information displayed on the display 1430.

[0315] In various embodiments, the treatment tool guidance instructions 1440 may include treatment tool movement data indicating one or more directions in which the treatment tool should be moved (e.g., shifted and / or tilted) and / or a measure of movement in each direction in order to bring the treatment tool into a position and direction within its allowable error range. For example, each direction may be presented using an arrow, where the length of the arrow may indicate the measure of movement required in the corresponding direction. However, other symbols may also be used. For example, the treatment tool guidance instructions 1440 may allow the treatment tool to be quickly and accurately aimed at a target area.

[0316] According to some embodiments, the method may include presenting, by processing unit 1410, treatment tool visual data 1450 on display 1430. For example, treatment tool visual data 1450 may include a visual representation of at least a portion of treatment tool 1452. For example, the visual representation of treatment tool 1452 may be displayed adjacent to treatment tool guide instructions 1440.

[0317] According to some embodiments, the method may include presenting, by processing unit 1410, system component visual data 1460 on display 1430. System component visual data 1460 may, for example, include a visual representation of one or more components of the system (e.g., a camera), and may indicate an actual positional orientation of the corresponding component relative to, for example, a treatment tool.

[0318] The treatment tool visual data 1450 and the system component visual data 1460 may, for example, enhance a user's understanding of the treatment tool guidance instructions 1440 .

[0319] Reference now Fig.15A and Fig. 15B , which are schematic diagrams of a second embodiment of a system 1500 for aiming and / or aligning a treatment tool 90 in an X-ray device 80 environment according to some embodiments of the present invention.

[0320] According to some embodiments, system 1500 may include a calibration plate 1510, a camera 1520, and a processing unit 1530 (e.g., Fig.15A and Fig. 15B shown). Fig.15A and Fig. 15B A side view of system 1500 is shown. System 1500 can align treatment tool 90 to target area 72 within patient 70 and / or align treatment tool 90 relative to x-ray device 80 while significantly reducing patient 70's exposure to x-ray radiation compared to a treatment procedure performed without system 1500.

[0321] According to some embodiments, calibration plate 1510 may include at least one optical marker 1514. Optical marker 1514 may be positioned on a surface of calibration plate 1510 at a predetermined and / or known location. Calibration plate 1510 may be connected or removably connected to treatment tool 90. For example, calibration plate 1510 and optical marker 1514 may be similar to those described above with respect to Figure 1 A calibration plate 110 (without radiopaque markers 112 ) and optical markers 114 are depicted.

[0322] According to some embodiments, the camera 1520 may be connectable or removably connectable to the X-ray device 80. The camera 1520 may be in a predetermined and / or known position and orientation relative to the X-ray device 80 (e.g., Fig.15A As shown) is connected to an X-ray device 80.

[0323] In some embodiments, the camera 1520 may include at least one radiopaque marker 1512. In this case, the camera 1520 may be attached to the X-ray device 80 so that at least its radiopaque marker 1512 will be disposed in the field of view 83a of the X-ray source 83. For example, the camera 1520 may be attached to the X-ray intensifier 82 (e.g., Fig. 15B ). Fig. 15B In the illustrated embodiment, the position and orientation of the camera 1520 relative to the x-ray device 80 may be unknown and may be determined based on x-ray imaging of the radiopaque markers 1512 attached to the camera 1520 (e.g., as described above with respect to Figure 1 described above).

[0324] In some embodiments, the system 1500 may include a camera connector 1522. The camera connector 1522 may be configured to tightly and stably connect the camera 1520 to the X-ray device 80 and prevent accidental relative movement of the camera 1520 with respect to the X-ray device 80.

[0325] According to some embodiments, the processing unit 1530 may communicate (eg, wired or wirelessly) with the camera 1520 and with the X-ray imaging unit 84 of the X-ray device 80 .

[0326] According to some embodiments, processing unit 1530 may be configured to receive one or more camera images of calibration plate 1510 from camera 1520. The camera images of calibration plate 1510 may include a visual representation of optical marker 1514.

[0327] According to some embodiments, processing unit 1530 may be configured to determine the position and orientation of calibration plate 1510 (which may be attached to, for example, treatment tool 90) relative to camera 1520 based on the visual representation of optical marker 1514 in the camera image, based on the known position of optical marker 1514 within calibration plate 1510, and based on parameters of camera 1520 (e.g., such as distortion, field of view 121, etc.). This determination may be utilized using, for example, a bundle adjustment / PNP algorithm.

[0328] According to some embodiments, the processing unit 1530 may be configured to determine the position and orientation of the treatment tool 90 relative to the X-ray device 80 based on the determined position and orientation of the calibration plate 1510 relative to the camera 1520 and the known position and orientation of the camera 1520 relative to the X-ray device 80.

[0329] exist Fig. 15B In the illustrated embodiment, in which the position and orientation of the camera 1520 relative to the X-ray device 80 are unknown and the camera 1520 includes a radiopaque marker 1512, the processing unit 1530 can be configured to receive an X-ray image including a visual representation of at least one radiopaque marker; and determine the position and orientation of the camera relative to the X-ray device based on the visual representation of the at least one radiopaque marker.

[0330] According to some embodiments, the system 1500 may include a display 1540. The processing unit 1530 may be configured to present at least one visual indicator 1542 indicating the determined position and orientation of the treatment tool 90, for example on the display 1540 and / or the X-ray display 86.

[0331] In some embodiments, the processing unit 1530 may be configured to determine whether the determined position and orientation of the treatment tool 90 relative to the X-ray device 80 is within an allowable error range compared to the required position and orientation of the treatment tool 90 relative to the X-ray device 80. In some embodiments, the processing unit 1530 may be configured to update the visual indicator 1542 to indicate whether the position and orientation of the treatment tool 90 is within its allowable error range. The modification of the visual indicator 1542 may, for example, include a change in the color and / or shape of the visual indicator 1542 (e.g., according to a predetermined rule).

[0332] In various embodiments, the processing unit 1530 may be configured to superimpose the visual indicator 1542 on an X-ray image of, for example, the target area 72 of the patient 70 to generate an overlay image, and display the overlay image on the display 1540 and / or the X-ray display 86.

[0333] In some embodiments, the processing unit 1530 may be configured to detect or mark the target area 72 in its X-ray image. The processing unit 1530 may be configured to determine whether the treatment tool 90 is aligned relative to the target area 72 based on the determined position and orientation of the treatment tool 90 and the X-ray image. In some embodiments, the processing unit 1530 may be configured to update the visual indicator 1542 to indicate whether the treatment tool 90 is aligned with the target area 72.

[0334] In some embodiments, the processing unit 1530 may generate treatment tool guidance instructions based on the determined position and orientation of the treatment tool 90 relative to the X-ray device 80, and display the treatment tool guidance instructions on the display 86 / 1540 (e.g., as described above with respect to Fig.14A and Fig. 14B The guidance instructions may indicate one or more directions in which the treatment tool 90 should move (e.g., shift and / or tilt) and / or the measure of movement in each direction so as to bring the treatment tool 90 into a position and orientation within its allowable error range. The treatment tool guidance instructions, for example, may make it easy and intuitive to aim and / or align the treatment tool 90 relative to the target area 72 and / or the X-ray device 80.

[0335] The system 1500 may enable a user (e.g., a treating physician) to aim the treatment tool 90 at the target area 72 and / or to align (e.g., translate, tilt, pitch, yaw, roll, etc.) the treatment tool 90 relative to the X-ray device 80 using a visual indicator 1542 displayed on the display 1540 and / or the X-ray display 86. The visual indicator 1542 may indicate the position and orientation of the treatment tool 90 relative to the X-ray device 80, which eliminates (or substantially eliminates) the need for X-ray imaging of the patient 70 during aiming and / or alignment of the treatment tool 90. When using the system 1500, X-ray imaging is only required in the final stages of aiming and / or aligning the treatment tool 90, and the actual position and orientation of the treatment tool 90 relative to the X-ray device 80 corresponds to its desired position and orientation or is within an allowable error range thereof before the treatment is applied. In this way, system 1500 can significantly reduce the patient and / or user's exposure to X-ray radiation during treatment, compared to current treatment procedures that require the patient to be exposed to X-ray radiation more than 70 times during aiming and / or aligning treatment tool 90.

[0336] Reference now Fig.16 , which is a flow chart of a second method of aiming and / or aligning a treatment tool in an X-ray device environment according to some embodiments of the present invention.

[0337] The method may be implemented by a system for aiming / aligning a treatment tool in an X-ray device environment (e.g., as described above with respect to Fig.15A and Fig. 15B The system 1500 described above can be implemented, which can be configured to implement the method. Note that the method is not limited to Fig.16 For example, in various embodiments, the method need not move through each illustrated box or stage, or in exactly the same order as illustrated and described.

[0338] According to some embodiments, the method includes attaching (or removably attaching) a calibration plate to the treatment tool, wherein the calibration plate includes at least one optical marker positioned at a predetermined position within the calibration plate (stage 1602). Fig.15A and Fig. 15B Calibration plate 1510 and optical marker 1514 are depicted.

[0339] Some embodiments may include attaching (or removably attaching) a camera to an X-ray device (stage 1604) (e.g., as described above with respect to Fig.15A and Fig. 15B For example, the above Fig.15A and Fig. 15B Camera 1520 is described.

[0340] Some embodiments may include obtaining, via a camera, a camera image including a visual representation of at least one optical marker (stage 1606) (e.g., as described above with respect to Figure 1 and Figure 4 described above).

[0341] Some embodiments may include determining a position and orientation of the calibration plate relative to the camera based on a visual representation of the at least one optical marker in the camera image and a position of the at least one optical marker within the calibration plate (stage 1607) (e.g., as described above with respect to Fig.15A and Fig. 15B For example, by using Fig.15A and Fig. 15B The bundle adjustment / PnP algorithm described.

[0342] Some embodiments may include determining the position and orientation of the treatment tool relative to the X-ray device based on the determined position and orientation of the calibration plate relative to the camera and the position and orientation of the camera relative to the X-ray device (stage 1608) (e.g., as described above with respect to Fig.15A and Fig. 15B described above).

[0343] In some embodiments, the position and orientation of the camera relative to the X-ray device may be known / predetermined.

[0344] In some other embodiments, the camera may be attached to the X-ray device at any position and orientation, at least partially in the field of view of the X-ray source of the X-ray device, and may include at least one radiopaque marker. These embodiments may include obtaining an X-ray image of at least a portion of the camera by the X-ray device, and determining the position and orientation of the camera relative to the X-ray device based on a visual representation of the at least one radiopaque marker in the X-ray image.

[0345] Some embodiments may include displaying a visual indicator on a display indicating the determined position and orientation of the treatment tool (stage 1610). Fig.15A and Fig. 15B Visual indicator 1542 of the description.

[0346] Some embodiments may include determining whether the determined position and orientation of the treatment tool relative to the x-ray device is within an allowable error range compared to the desired position and orientation of the treatment tool relative to the x-ray device (stage 1612) (e.g., as described above with respect to Fig.15A and Fig. 15B described above).

[0347] Some embodiments may include updating the visual indicator to thereby indicate whether the position and orientation of the treatment tool relative to the x-ray device is within its allowed error range (stage 1614) (e.g., as described above with respect to Fig.15A and Fig. 15B described above).

[0348] Some embodiments may include overlaying the visual indicator and the x-ray image of the target area of ​​the patient to produce an overlay image, and displaying the overlay image on a display (stage 1616).

[0349] Some embodiments may include detecting or marking a target area in an X-ray image thereof, and determining whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the X-ray image (stage 1618).

[0350] Some embodiments may include updating a visual indicator to indicate whether the treatment tool is aligned with the target area (stage 1620).

[0351] Some embodiments may include generating and displaying on a display treatment tool guidance instructions indicating one or more directions in which the treatment tool should be moved (e.g., shifted and / or tilted) and / or a measure of movement in each direction in order to bring the treatment tool into a position and orientation within its allowable error range (stage 1622). For example, as described above with respect to Fig.14A and Fig. 14BThe treatment tool guidance instructions can be determined based on the determined position and orientation of the treatment tool relative to the X-ray device. The treatment tool guidance instructions can, for example, make it easy and intuitive to aim and / or align the treatment tool relative to the target area and / or the X-ray device.

[0352] Some embodiments may include aiming and aligning the treatment tool according to visual indicators displayed on the display without exposing the patient to X-ray imaging of the X-ray device (stage 1624) (e.g., as described above with respect to Fig.15A and Fig. 15B described above).

[0353] Reference now Fig.17 , which is a schematic diagram of a second embodiment of a system 1700 for aiming and / or aligning a treatment tool 90 in an ultrasound imaging device 60 environment according to some embodiments of the present invention.

[0354] According to some embodiments, system 1700 may include a calibration plate 1710 , a camera 1720 , and a processing unit 1730 . Fig.17 A side view of system 1700 is shown. System 1700 can align treatment tool 90 with target area 72 within patient 70 and / or align treatment tool 90 with respect to ultrasound imaging probe 62.

[0355] The ultrasound imaging device 60 may be any type of ultrasound imaging device, such as a handheld device, a laptop device, a probe connected to a cell phone or tablet computer, or a system on a portable cart, and may include one or more probes and other accessories.

[0356] The treatment tool 90 may be, for example, an invasive treatment tool (e.g., a needle (e.g., a biopsy needle, a radiofrequency needle) and / or a probe) or a non-invasive treatment tool (e.g., an ultrasound transducer or a focused ultrasound transducer) that requires aiming relative to the target area 72 and / or alignment relative to the ultrasound imaging probe 62. For example, Fig.17 A needle is shown as an example of the treatment tool 90 .

[0357] According to some embodiments, calibration plate 1710 may include at least one optical marker. The optical marker may be positioned at a predetermined and / or known location within calibration plate 1710. Calibration plate 1710 may be connectably or removably connected to treatment tool 90.

[0358] According to some embodiments, the camera 1720 may be connectably or removably connected to the ultrasound imaging probe 62 of the ultrasound device 60. The camera 1720 may be attached to the ultrasound imaging probe 62 at a predetermined and / or known position and orientation relative to the treatment tool 90. The camera 1720 may be attached to the ultrasound imaging probe 62 such that at least a portion of the calibration plate 1710 will be within the field of view 1721 of the camera 1720.

[0359] In some embodiments, the system 1700 may include a camera connector 1722. The camera connector 1722 may be configured to tightly and stably connect the camera 1720 to the ultrasound imaging probe 62 and prevent accidental relative movement of the camera 1720 with respect to the ultrasound imaging probe 62.

[0360] According to some embodiments, the processing unit 1730 may communicate (eg, wired or wirelessly) with the camera 1720 and with the ultrasound imaging unit 64 of the ultrasound imaging device 60 .

[0361] According to some embodiments, processing unit 1730 may be configured to receive one or more camera images of calibration plate 1710 from camera 1720. The camera images of calibration plate 1710 may include visual representations of optical markers.

[0362] According to some embodiments, the processing unit 1730 may be configured to determine the position and orientation of the calibration plate 1710 relative to the camera 1720 (which may be attached to, for example, the ultrasound imaging probe 62) based on the visual representation of the optical markers in the camera image, based on the known positions of the optical markers within the calibration plate 1710, and based on parameters of the camera 1720 (e.g., such as distortion, field of view 1721, etc.). This determination may be utilized using, for example, a bundle adjustment / PNP algorithm.

[0363] According to some embodiments, the processing unit 1730 may be configured to determine the position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62 based on a predetermined position and orientation of the calibration plate 1710 relative to the treatment tool 90, a determined position and orientation of the calibration plate 1710 relative to the camera 1720, and a known position and orientation of the camera 1720 relative to the ultrasound imaging probe 62.

[0364] According to some embodiments, the system 1700 may include a display 1740. The processing unit 1730 may be configured to present at least one visual indicator 1742 indicating the determined position and orientation of the treatment tool 90 on the display 1740 and / or the ultrasound display 66, for example.

[0365] In some embodiments, the processing unit 1730 may be configured to determine whether the determined position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62 is within an allowable error range compared to the required position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62. The processing unit 1730 may be configured to modify the visual indicator 1742 to indicate whether the position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62 is within its allowable error range.

[0366] In various embodiments, the processing unit 1730 may be configured to superimpose the visual indicator 1742 on an ultrasound image of, for example, the target area 72 of the patient 70 to generate an overlay image, and display the overlay image on the display 1740 and / or the ultrasound display 66 .

[0367] In some embodiments, the processing unit 1730 may be configured to detect or mark the target area 72 in its ultrasound image. The processing unit 1730 may be configured to determine whether the treatment tool 90 is aligned relative to the target area 72 based on the determined position and orientation of the treatment tool 90 and the ultrasound image. In some embodiments, the processing unit 1730 may be configured to update the visual indicator 142 to indicate whether the treatment tool 90 is aligned with the target area 72.

[0368] In some embodiments, the processing unit 1730 may generate a treatment tool guidance instruction based on the determined position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62, and display the treatment tool guidance instruction on the display 86 / 1740 (e.g., as described above with respect to Fig.14A and Fig. 14B The treatment tool guidance instructions may indicate one or more directions in which the treatment tool 90 should be moved (e.g., shifted and / or tilted) and / or the measure of movement in each direction so as to bring the treatment tool 90 into a position and orientation that is within its allowed error range and / or aligned with respect to the target area 72. The treatment tool guidance instructions may, for example, make it easy and intuitive to aim and / or align the treatment tool 90 with respect to the target area 72 and / or the ultrasound imaging probe 62.

[0369] The system 1700 enables a user (e.g., a treating physician) to aim the treatment tool 90 at the target area 72 and / or align the treatment tool 90 relative to the ultrasound imaging probe 62 (e.g., translation, tilt, pitch, yaw, roll, etc.) using a display 1740 and / or visual indicators 1742 displayed on the ultrasound display 66. The visual indicators 1742 may indicate the position and orientation of the treatment tool 90 relative to the ultrasound imaging probe 62, which eliminates (or substantially eliminates) the need for ultrasound imaging of the treatment tool tip. When using the system 1700, ultrasound imaging of the treatment tool tip is only required (where applicable) during the final stages of aiming and / or alignment of the treatment tool 90 in order to verify that the actual position and orientation of the treatment tool 90 relative to the patient's anatomy is correct before applying the treatment. In this way, the system 1700 may significantly reduce procedure time compared to current treatment procedures.

[0370] Reference now Fig.18 , which is a flow chart of a second method of aiming and / or aligning a treatment tool in an ultrasound imaging device environment according to some embodiments of the present invention.

[0371] The method may be provided by a system for aiming / aligning a treatment tool in an ultrasound imaging device environment (e.g., as described above with respect to Fig.17 The system 1700 described above can be implemented, which can be configured to implement the method. Note that the method is not limited to Fig.18 The flowcharts shown and the corresponding descriptions. For example, in various embodiments, the method need not move through each of the boxes or stages shown, or in exactly the same order as shown and described.

[0372] According to some embodiments, the method includes attaching (or removably attaching) a calibration plate to the treatment tool, wherein the calibration plate includes at least one optical marker located at a predetermined position within the calibration plate (stage 1802). Fig.17 Calibration plate 1710 is described.

[0373] Some embodiments may include attaching (or removably attaching) a camera to an ultrasound imaging probe (stage 1804) at a predetermined position and orientation relative to the ultrasound imaging probe (e.g., as described above with respect to Fig.17 For example, the above Fig.17 Camera 1720 is described.

[0374] Some embodiments may include obtaining, by a camera, a camera image including a visual representation of at least one optical marker (stage 1806) (e.g., as described above with respect to Fig.17 described above).

[0375] Some embodiments may include determining a position and orientation of the calibration plate relative to the camera based on a visual representation of at least one optical marker in the camera image and a predetermined position of at least one optical marker within the calibration plate (stage 1808) (e.g., as described above with respect to Fig.17 For example, by using Fig.17 The bundle adjustment / PnP algorithm described.

[0376] Some embodiments may include determining a position and orientation of the treatment tool relative to the ultrasound imaging probe based on a predetermined position and orientation of the calibration plate relative to the treatment tool, a determined position and orientation of the calibration plate relative to the camera, and a predetermined position and orientation of the camera relative to the ultrasound imaging probe (stage 1810) (e.g., as described above with respect to Fig.17 described above).

[0377] Some embodiments may include displaying a visual indicator on a display indicating the determined position and orientation of the treatment tool relative to the ultrasound imaging probe (stage 1812). Fig.17 Visual indicator 1742 of the description.

[0378] Some embodiments may include determining whether the determined position and orientation of the treatment tool relative to the ultrasound imaging probe is within an allowable error range compared to the required position and orientation of the treatment tool relative to the ultrasound imaging probe (stage 1813). For example, this may allow the treatment tool to be quickly and accurately aimed at the target area.

[0379] Some embodiments may include modifying the visual indicator to thereby indicate whether the position and orientation of the treatment tool relative to the ultrasound imaging probe is within its allowed error range (stage 1814).

[0380] Some embodiments may include superimposing the visual indicator and the ultrasound image of the target area of ​​the patient to produce an overlay image, and displaying the overlay image on a display (stage 1815).

[0381] Some embodiments may include detecting or marking a target area in an ultrasound image thereof, and determining whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the ultrasound image (stage 1816).

[0382] Some embodiments may include updating a visual indicator to indicate whether the treatment tool is aligned with the target area (stage 1817).

[0383] Some embodiments may include generating and displaying on a display treatment tool guidance instructions indicating one or more directions in which the treatment tool should be moved (e.g., shifted and / or tilted) and / or a measure of movement in each direction in order to bring the treatment tool into a position and orientation within an allowable error range (stage 1818). For example, as described below with respect to Fig.14A and Fig. 14B This may, for example, allow a therapeutic tool to be quickly and accurately aimed at a target area.

[0384] Some embodiments may include aiming and / or aligning the treatment tool based on at least one visual indicator displayed on the display (stage 1819).

[0385] Advantageously, the disclosed systems and methods can enable a user (e.g., a treating physician) to aim a treatment tool at a target area within a patient and / or to aim a treatment tool relative to an imaging device using visual indicators (e.g., displayed on a display) that are configured to indicate a determined position and orientation of the treatment tool relative to an imaging device. This can be accomplished without mechanically connecting the treatment tool to the imaging device and without requiring complex and / or expensive tracking units that are required in current procedures. Additionally, the disclosed systems and methods can increase the accuracy of the treatment procedure, reduce its reliance on user proficiency for accuracy, and / or reduce the duration of the treatment procedure as compared to current treatment procedures that do not utilize the disclosed systems and methods.

[0386] In the case of an X-ray imaging device, the disclosed systems and methods can eliminate the need for X-ray imaging of the patient during aiming and / or alignment of the treatment tool, which can significantly reduce the patient's and / or user's exposure to X-ray radiation during the treatment process and / or significantly reduce the duration of the treatment process compared to current treatment processes that require X-ray imaging of the patient during aiming and / or alignment of the treatment tool. When using the disclosed systems and methods, X-ray imaging of the treatment tool and the patient is only required in the final stages of aiming and / or alignment of the treatment tool in order to verify that the actual position and orientation of the treatment tool relative to the X-ray device corresponds to its desired position and orientation or is within its allowed error range before applying the treatment.

[0387] Aspects of the present invention are described above with reference to flowcharts and / or partial diagrams of methods, devices (systems) and computer program products according to embodiments of the present invention. It will be understood that each portion of the flowchart illustrations and / or partial diagrams and the combination of portions in the flowchart illustrations and / or partial diagrams can be implemented by computer program instructions. These computer program instructions can be provided to a processor of a general-purpose computer, a special-purpose computer or other programmable data processing device to produce a machine, so that instructions executed by the processor of the computer or other programmable data processing device create a device for implementing the functions / actions specified in the flowchart and / or partial diagram or a portion thereof.

[0388] These computer program instructions may also be stored in a computer-readable medium, which may direct a computer, other programmable data processing device, or other device to operate in a specific manner, so that the instructions stored in the computer-readable medium produce an article of manufacture including instructions that implement the functions / actions specified in one or more portions of the flowchart and / or partial diagrams thereof. The computer program instructions may also be loaded onto a computer, other programmable data processing device, or other device to cause a series of operational steps to be performed on the computer, other programmable device, or other device to produce a computer-implemented process, so that the instructions executed on the computer or other programmable device provide a process for implementing the functions / actions specified in one or more portions of the flowchart and / or partial diagrams thereof.

[0389] The foregoing flowcharts and diagrams illustrate the possible implementation architecture, functions and operations of the system, method and computer program product according to various embodiments of the present invention. In this regard, each part in the flowchart or partial diagram may represent a module, a code segment or a code portion, which includes one or more executable instructions for implementing the specified logical function. It should also be noted that in some alternative embodiments, the functions indicated in the section may not be performed in the order indicated in the figure. For example, depending on the functions involved, two parts shown in succession may actually be executed substantially simultaneously, or sometimes the parts may be executed in the opposite order. It should also be noted that each part of the partial diagram and / or flowchart illustration, as well as the combination of parts in the partial diagram and / or flowchart illustration, can be implemented by a dedicated hardware-based system that performs the specified function or action, or a combination of dedicated hardware and computer instructions.

[0390] In the above description, an embodiment is an example or implementation of the present invention. The various appearances of "one embodiment", "an embodiment", "certain embodiments" or "some embodiments" do not necessarily all refer to the same embodiment. Although various features of the present invention may be described in the context of a single embodiment, these features may also be provided separately or in any suitable combination. Conversely, although the present invention may be described in the context of separate embodiments for clarity, the present invention may also be implemented in a single embodiment. Certain embodiments of the present invention may include features from different embodiments disclosed above, and certain embodiments may include elements from other embodiments disclosed above. The disclosure of elements of the invention in the context of a particular embodiment should not be viewed as limiting their use only in a particular embodiment. Furthermore, it should be understood that the present invention may be implemented or practiced in various ways, and that the present invention may be implemented in certain embodiments other than the embodiments outlined in the above description.

[0391] The present invention is not limited to those figures or corresponding descriptions. For example, the flow does not have to pass through each illustrated box or state, or move in exactly the same order as the illustrated and described order. Unless otherwise defined, the meaning of the technical and scientific terms used herein should be generally understood by a person of ordinary skill in the art to which the present invention belongs. Although the present invention has been described with respect to a limited number of embodiments, these should not be interpreted as limitations on the scope of the present invention, but as examples of some preferred embodiments. Other possible variations, modifications and applications are also within the scope of the present invention. Accordingly, the scope of the present invention should not be limited by what has been described so far, but by the appended claims and their legal equivalents.

Claims

1. A system for aiming and aligning a treatment tool in an X-ray device environment, the system comprising: a calibration plate attachable to an X-ray device and comprising at least one radiopaque marker and at least one optical marker at a predetermined position within said calibration plate; a camera attachable to the treatment tool at a predetermined position and orientation relative to the treatment tool; as well as a processing unit in communication with the camera and an X-ray imaging unit of the X-ray device, the processing unit being configured to: receiving, from the X-ray imaging unit, an X-ray image including a visual representation of the at least one radiopaque marker; determining a position and orientation of the calibration plate relative to the X-ray device based on the visual representation of the at least one radiopaque marker in the X-ray image, the predetermined position of the at least one radiopaque marker within the calibration plate, and specified parameters of the X-ray device; receiving from the camera a camera image including a visual representation of the at least one optical marker; determining a position and orientation of the camera relative to the calibration plate based on the visual representation of the at least one optical marker in the camera image and the predetermined position of the at least one optical marker within the calibration plate; as well as The position and orientation of the treatment tool relative to the X-ray device is determined based on the determined position and orientation of the calibration plate relative to the X-ray device, the determined position and orientation of the camera within the calibration plate, and the predetermined position and orientation of the camera relative to the treatment tool.

2. The system according to claim 1, wherein: Each of the at least one optical mark of the calibration plate includes a visible label that encodes a position of the corresponding optical mark within the calibration plate.

3. The system according to claim 1, wherein: The calibration plate comprises at least one of the following: at least one asymmetric radiopaque marker; and A plurality of symmetrical radiopaque markers are asymmetrically positioned within the calibration plate.

4. The system according to claim 1, wherein: The calibration plate includes a plurality of optical marks.

5. The system according to any one of claims 1 to 4, wherein: The processing unit is configured to present a visual indicator on a display indicating the determined position and orientation of the treatment tool.

6. The system according to claim 5, wherein: The processing unit is configured to superimpose the visual indicator on an X-ray image of a target area within a patient.

7. The system according to claim 6, wherein: The processing unit is configured to: Detecting or marking the target area in the X-ray image; determining whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the x-ray image; as well as The visual indicator is modified to indicate whether the treatment tool is aligned relative to the target area.

8. The system according to any one of claims 1 to 7, wherein: The processing unit is configured to: generating treatment tool guidance instructions based on the determined position and orientation of the treatment tool relative to the X-ray device; and The treatment tool guidance instructions are displayed on a display.

9. The system according to claim 8, wherein: The treatment tool guidance instructions indicate one or more directions in which the treatment tool should be moved and a measure of movement in each of the one or more directions so as to bring the treatment tool into a position and orientation within its allowable error range.

10. The system according to any one of claims 8 to 9, wherein: The processing unit is configured to display at least one of: treatment tool visual data, including a visual representation of at least a portion of the treatment tool; as well as System component visual data includes a visual representation of at least one component of the system and indicates an actual position and orientation of the corresponding at least one component relative to the treatment tool.

11. The system according to any one of claims 1 to 10, wherein: The treatment tool is one of the following: a focused ultrasound transducer and an interventional treatment tool.

12. A system for aiming and aligning a treatment tool in an ultrasound imaging device environment, the system comprising: a calibration plate capable of being attached to an ultrasound imaging probe of the ultrasound imaging device and comprising at least one optical mark at a predetermined position within the calibration plate; a camera attachable to the treatment tool at a predetermined position and orientation relative to the treatment tool; as well as a processing unit in communication with the camera and an ultrasound imaging unit of the ultrasound imaging device, the processing unit being configured to: receiving from the camera a camera image including a visual representation of the at least one optical marker; determining a position and orientation of the camera relative to the calibration plate based on the visual representation of the at least one optical marker in the camera image and the predetermined position of the at least one optical marker within the calibration plate; as well as Based on the predetermined position and orientation of the calibration plate relative to the ultrasound imaging probe, the determined position and orientation of the camera relative to the calibration plate, and the known position and orientation of the camera relative to the treatment tool, the position and orientation of the treatment tool relative to the ultrasound imaging probe are determined.

13. The system according to claim 12, wherein: The calibration plate includes a plurality of optical marks.

14. A system according to any one of claims 12 to 13, wherein: The processing unit is configured to present a visual indicator on a display indicating the determined position and orientation of the treatment tool.

15. The system of claim 14, wherein: The processing unit is configured to: determining whether the determined position and orientation of the treatment tool relative to the ultrasound imaging probe are within an allowable error range compared to the required position and orientation of the treatment tool relative to the ultrasound imaging probe; and The visual indicator is modified to thereby indicate whether the position and orientation of the treatment tool relative to the ultrasound imaging probe is within the allowable error range thereof.

16. A system according to any one of claims 12 to 15, wherein: The processing unit is configured to superimpose the visual indicator on an ultrasound image of a target area within a patient.

17. The system of claim 16, wherein: The processing unit is configured to: Detecting or marking the target area in the ultrasound image; determining whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the ultrasound image; as well as The visual indicator is modified to indicate whether the treatment tool is aligned relative to the target area.

18. A system according to any one of claims 14 to 17, wherein: The processing unit is configured to: generating a treatment tool guidance instruction based on the determined position and orientation of the treatment tool relative to the ultrasound imaging probe; and The treatment tool guidance instructions are displayed on a display.

19. The system of claim 18, wherein: The treatment tool guidance instructions indicate one or more directions in which the treatment tool should be moved and a measure of movement in each of the one or more directions so as to bring the treatment tool into a position and orientation within its allowable error range.

20. The system according to any one of claims 18 to 19, wherein: The processing unit is configured to display at least one of: treatment tool visual data, including a visual representation of at least a portion of the treatment tool; as well as System component visual data includes a visual representation of at least one component of the system and indicates an actual position and orientation of the corresponding at least one component relative to the treatment tool.

21. A system according to any one of claims 12 to 20, wherein: The treatment tool is one of the following: a focused ultrasound transducer and an interventional treatment tool.

22. A system for aiming and aligning a treatment tool in an X-ray device environment, the system comprising: a calibration plate attachable to the treatment tool and comprising at least one optical marker at a predetermined location within the calibration plate; a camera attachable to the X-ray device; as well as a processing unit in communication with the camera and an X-ray imaging unit of the X-ray device, the processing unit being configured to: receiving from the camera a camera image including a visual representation of the at least one optical marker; determining a position and orientation of the calibration plate relative to the camera based on the visual representation of the at least one optical marker in the camera image and the predetermined position of the at least one optical marker within the calibration plate; as well as Based on the determined position and orientation of the calibration plate relative to the camera and the position and orientation of the camera relative to the X-ray device, the position and orientation of the treatment tool relative to the X-ray device is determined.

23. The system of claim 22, wherein: Each of the at least one optical mark of the calibration plate includes a visible label that encodes a position of the corresponding optical mark within the calibration plate.

24. The system of claim 22, wherein: The position and orientation of the camera are known.

25. The system of claim 22, wherein: The camera includes at least one radiopaque marker disposed at least partially within a field of view of an x-ray source of the x-ray device; and The processing unit is configured to: receiving an X-ray image including a visual representation of the at least one radiopaque marker; as well as A position and orientation of the camera relative to the X-ray device is determined based on the visual representation of the at least one radiopaque marker.

26. A system according to any one of claims 22 to 25, wherein: The calibration plate includes a plurality of optical marks.

27. A system according to any one of claims 22 to 26, wherein: The processing unit is configured to: generating treatment tool guidance instructions based on the determined position and orientation of the treatment tool relative to the X-ray device; and The treatment tool guidance instructions are displayed on a display.

28. The system of claim 27, wherein: The treatment tool guidance instructions indicate one or more directions in which the treatment tool should be moved and the measure of movement in each of the one or more directions so as to bring the treatment tool into a position and orientation within its allowed error range.

29. A system according to any one of claims 27 to 28, wherein: The processing unit is configured to display at least one of: treatment tool visual data, including a visual representation of at least a portion of the treatment tool; as well as System component visual data includes a visual representation of at least one component of the system and indicates an actual position and orientation of the corresponding at least one component relative to the treatment tool.

30. A system according to any one of claims 22 to 29, wherein: The treatment tool is one of the following: a focused ultrasound transducer and an interventional treatment tool.

31. A system for aiming and aligning a treatment tool in an ultrasound imaging device environment, the system comprising: a calibration plate attachable to the treatment tool and comprising at least one optical marker at a predetermined location within the calibration plate; a camera attachable to the ultrasound imaging probe at a predetermined position and orientation relative to the ultrasound imaging probe; and a processing unit in communication with the camera and an ultrasound imaging unit of the ultrasound imaging device, the processing unit being configured to: receiving from the camera a camera image including a visual representation of the at least one optical marker; determining a position and orientation of the calibration plate relative to the camera based on the visual representation of the at least one optical marker in the camera image and the predetermined position of the at least one optical marker within the calibration plate; as well as Based on the predetermined position and orientation of the calibration plate relative to the treatment tool, the determined position and orientation of the calibration plate relative to the camera, and the known position and orientation of the camera relative to the ultrasound imaging probe, the position and orientation of the treatment tool relative to the ultrasound imaging probe are determined.

32. The system of claim 31, wherein: The calibration plate includes a plurality of optical marks.

33. A system according to any one of claims 31 to 32, wherein: The processing unit is configured to present a visual indicator on a display indicating the determined position and orientation of the treatment tool.

34. The system of claim 33, wherein: The processing unit is configured to: determining whether the determined position and orientation of the treatment tool relative to the ultrasound imaging probe are within an allowable error range compared to the required position and orientation of the treatment tool relative to the ultrasound imaging probe; and The visual indicator is modified to thereby indicate whether the position and orientation of the treatment tool relative to the ultrasound imaging probe is within the allowable error range thereof.

35. A system according to any one of claims 33 to 34, wherein: The processing unit is configured to superimpose the visual indicator on an ultrasound image of a target area within a patient.

36. The system of claim 33, wherein: The processing unit is configured to: Detecting or marking the target area in the ultrasound image; determining whether the treatment tool is aligned relative to the target area based on the determined position and orientation of the treatment tool and the ultrasound image; as well as The visual indicator is modified to indicate whether the treatment tool is aligned relative to the target area.

37. A system according to any one of claims 33 to 34, wherein: The processing unit is configured to: generating a treatment tool guidance instruction based on the determined position and orientation of the treatment tool relative to the ultrasound imaging probe; and The treatment tool guidance instructions are displayed on a display.

38. The system of claim 35, wherein: The treatment tool guidance instructions indicate one or more directions in which the treatment tool should be moved and the measure of movement in each of the one or more directions so as to bring the treatment tool into a position and orientation within its allowed error range.

39. A system according to any one of claims 31 to 36, wherein: The processing unit is configured to display at least one of: treatment tool visual data, including a visual representation of at least a portion of the treatment tool; as well as System component visual data includes a visual representation of at least one component of the system and indicates an actual position and orientation of the corresponding at least one component relative to the treatment tool.

40. A system according to any one of claims 33 to 39, wherein: The treatment tool is one of the following: a focused ultrasound transducer and an interventional treatment tool.

Images