Magnetic resonance-guided abdominal intervention robot

Abstract

A magnetic resonance-guided abdominal intervention robot system was developed consisting of two stacked stages, each with two degrees of freedom, that facilitate needle insertion and control. The robot was actuated using 3D-printed pneumatic turbines with magnetic resonance-conditional bevel gear transmission systems. Pneumatic valves and control mechatronics were located inside the MRI control room and were connected to the robot with pneumatic transmission lines and optical fibers. The system was compact and capable of fitting within a standard magnetic resonance imaging bore even with large patients.

Description

MAGNETIC RESONANCE-GUIDED ABDOMINAL INTERVENTION ROBOTCross-Reference to Related Applications

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 588,466, filed October 6, 2023, which is incorporated herein by reference in its entirety.Background

[0002] Magnetic resonance-guided microwave ablation (MW A) has proven effective in treating hepatocellular carcinoma (HCC) with small-sized tumors, but the state-of-the-art technique experiences suboptimal workflow due to the limited accuracy provided by manual needle insertions.

[0003] Both MWA and other needle based interventions require precise and safe needle trajectories toward dynamically moving targets (e.g., within the liver). In the current practice, the clinicians typically increase the ablation power to generate a larger ablation zone in the hope to compensate for the inaccurate needle placement, but this will inevitably lead to unintended collateral thermal injury, particularly when are located near critical structures such as the colon, diaphragm, gallbladder, or main bile duct.

[0004] There would be, therefore, a benefit to improving the magnetic resonance- guided intervention system.Summary

[0005] This disclosure presents a novel body-mounted robot that can accurately deploy an ablation needle to any dynamic liver targets with intraoperative MRI guidance. The disclosed robots and systems thereof accomplish at least the following design targets: (i) high-accuracy motion generated by the gear-based robotic actuation system; (ii) step-wise deployment of the ablation needle via the customized needle insertion unit that synchronizes with the respiration cycle; and (iii) real-time MRI feedback of target and needle tip for closed-loop task-space control.

[0006] An exemplary magnetic resonance-guided abdominal intervention robot is disclosed comprising two stacked stages, each with two degrees of freedom, to facilitate needle insertion and control. In some implementations, the exemplary robot is actuated using 3D-printed pneumatic turbines with magnetic resonance-conditional bevel gear transmission systems. Pneumatic valves and control mechatronics are located inside the magneticresonance imaging control room and are connected to the exemplary robot with pneumatic transmission lines and optical fibers.

[0007] In an aspect, a needle insertion and tracking device is disclosed. The needle insertion and tracking device includes a first carriage, a second carriage, and at least one actuator. The first carriage includes an upper guide movable along a first plane in each of a first direction and a second direction. The second carriage includes a lower guide movable along a second plane in each of the first direction and the second direction. The second plane is substantially parallel to and spaced apart from the first plane. The at least one actuator is coupled to each of the first carriage and the second carriage. The at least one actuator is configured to controllably move the upper guide to a desired first location in the first plane and to controllably move the lower guide to a desired second location in the second plane. The needle insertion and tracking device is compatible with a magnetic resonance imaging machine and includes non-metallic materials.

[0008] In some implementations, the needle insertion and tracking device further includes a needle guide coupled to the upper guide of the first carriage and extending to the lower guide of the second carriage.

[0009] In some implementations, the needle guide is configured for accepting a needle or a microwave ablation tool and guiding insertion of the needle or the microwave ablation tool into a target location.

[0010] In some implementations, the desired first location of the upper guide and the desired second location of the lower guide facilitate orientation the needle guide along a first vector, wherein the first vector is selected based on a target location spaced apart from the needle insertion and tracking device (e.g., a target location of a patient's abdomen).

[0011] In some implementations, the first carriage includes the upper guide is slidable along one or more guide rods disposed in the first plane via one or more spherical bearings.

[0012] In some implementations, the second carriage includes the lower guide is slidable along one or more guide rods disposed in the second plane via one or more spherical bearings.

[0013] In some implementations, the at least one actuator includes a first motor (e.g., a pneumatic motor) configured to drive a first lead screw that is coupled to the first carriage to move the first carriage along the first plane in one of the first direction or the second direction.

[0014] In some implementations, the at least one actuator includes a second motor (e.g., a pneumatic motor) configured to drive a second lead screw that is coupled to the firstcarriage to move the first carriage along the first plane in the other one of the first direction or the second direction.

[0015] In some implementations, the at least one actuator includes at least one piezoelectric actuator configured move the first carriage and / or the second carriage in one or more of the first direction and the second direction.

[0016] In some implementations, the needle insertion and tracking device further includes a third lead screw coupled to the second lead screw via a timing belt to ensure consistent motion across opposing sides of the needle insertion and tracking device.

[0017] In some implementations, the at least one actuator is coupled to a gearbox configured for gear reduction.

[0018] In some implementations, the needle insertion and tracking device further includes a plurality of optic encoders coupled to at least the first and second carriages, the plurality of optic encoders configured to track the motion of the first and second carriages in the first and second planes, respectively.

[0019] In some implementations, the needle insertion and tracking device further includes a housing (e.g., including one or more supporting plates) defining a cavity within which the first and second carriages are disposed, the cavity including at least one insertion opening aligned with the lower guide and at least one insertion opening aligned with the upper guide, the at least one insertion opening facilitating the insertion of the needle or the microwave ablation tool into, through, and out of the cavity.

[0020] In some implementations, the needle insertion and tracking device further includes at least one port configured to provide an input or an output for a pneumatic conduit, a fiber optic cable, and / or an other magnetic resonance compatible signal line.

[0021] In some implementations, the needle insertion and tracking device further includes an attachment device (e.g., straps) configured to affix the needle insertion and tracking device to a patient.

[0022] In some implementations, the first direction is an x-direction and the second direction is a y-direction.

[0023] In some implementations, the first direction is a first circular direction (e.g., a radial, circumferential, polar, or azimuthal direction), and the second direction is a second circular (e.g., radial, circumferential, polar, or azimuthal direction).

[0024] In another aspect, a system is disclosed. The system includes a needle insertion and tracking device, an actuation system, and a control system. The needle insertion and tracking device includes a first carriage including an upper guide movable along a firstplane in each of a first direction and a second direction. The needle insertion and tracking device further includes a second carriage including a lower guide movable along a second plane in each of the first direction and the second direction. The second plane is substantially parallel to and spaced apart from the first plane. The needle insertion and tracking device further includes a needle guide coupled to the upper guide of the first carriage and extending to the lower guide of the second carriage. The needle insertion and tracking device is compatible with a magnetic resonance imaging machine and includes non-metallic materials. The actuation system includes a plurality of actuators including a first actuator and a second actuator. The first actuator is coupled to the first carriage and configured to controllably move the upper guide to a desired first location in the first plane. The second actuator is coupled to the second carriage and configured to controllably move the lower guide to a desired second location in the second plane. The actuation system further includes a pump in fluid communication with the first and second actuators. The control system is in communication with each of the needle insertion and tracking device and the actuation system. The control system is configured to collect position data about the first and second carriages. The control system is further configured to move the first and second carriages to the desired first and second locations via the actuation system.

[0025] In some implementations, the actuation system is a piezoelectric actuation system, and the first and second actuators are at least one first and second piezoelectric actuator.

[0026] In some implementations, the actuation system is a pneumatic actuation system, and the first and second actuators are a first and second pneumatic motors, the pneumatic actuation system further including a manifold including at least one valve, the manifold coupled between the pump and the first and second pneumatic motors, wherein one or more pneumatic conduits are coupled between the manifold and the plurality of pneumatic motors.

[0027] In some implementations, at least one valve of the manifold is controllable to open or close based on instructions from the control system, wherein, when a first valve of the at least one valve coupled to the first pneumatic motor is open, the first pneumatic motor causes the first carriage to move in one of the first direction or the second direction.

[0028] In some implementations, the first carriage including the upper guide is slidable along one or more guide rods disposed in the first plane via one or more spherical bearings, and wherein the second carriage including the lower guide is slidable along one or more guide rods disposed in the second plane via one or more spherical bearings.

[0029] In some implementations, the desired first location of the upper guide and the desired second location of the lower guide facilitate orientation of the needle guide along a desired vector, wherein the desired vector is selected based on a target location spaced apart from the needle insertion and tracking device (e.g., a target location of a patient's abdomen).

[0030] In some implementations, the needle insertion and tracking device further includes a plurality of optic encoders coupled to at least the first and second carriages, the plurality of optic encoders configured to track the motion of the first and second carriages in the first and second planes, respectively, and relay positional data about the first and second carriages to the control system.

[0031] In some implementations, the control system is configured to interpret positional data about the first and second carriages, calculate a directional vector of the needle guide, and activate the actuation system to move one or more of the first and second carriages to adjust the directional vector to match the desired vector.

[0032] In some implementations, a method is disclosed. The method includes providing a needle insertion and tracking device, the needle insertion and tracking device including a first carriange, a second carriage, and a needle guide, and at least one actuator. The first carriage includes an upper guide movable along a first plane in each of a first direction and a second direction. The second carriage includes a lower guide movable along a second plane in each of the first direction and the second direction. The second plane is substantially parallel to and spaced apart from the first plane. The needle guide is coupled to the upper guide of the first carriage and extends to the lower guide of the second carriage. The at least one actuator is coupled to each of the first carriage and the second carriage. The at least one actuator is configured to controllably move the upper guide to a desired first location in the first plane and to controllably move the lower guide to a desired second location in the second plane. The needle insertion and tracking device is compatible with a magnetic resonance imaging (MRI) machine and includes non-metallic materials. The method further includes securing the needle insertion and tracking device to a patient adjacent to a target region (e.g., the liver of the patient). The method further includes selecting a target point of the target region and an entry point on a patient's skin (e.g., aligned with a desired vector of the device). The method further includes moving the first carriage and the second carriage such that a projected vector of the needle guide aligns with one or both of the target point and the entry point.

[0033] In some implementations, the method further includes inserting a needle (e.g., a microwave ablation needle) into the needle guide and towards through the entry point; tracking the location of the needle via the MRI machine.

[0034] In some implementations, the method further includes adjusting (e.g., manually via a clinician) a location and / or a direction of the needle based on information from the MRI machine.

[0035] In some implementations, the adjusting is automatically performed via a control system.

[0036] In some implementations, the method further includes performing a microwave ablation procedure at the target point with the needle.

[0037] In some implementations, moving the first carriage and the second carriage is performed via a pneumatic actuation system including the at least one actuator, wherein the at least one actuator includes a first pneumatic motor and a second pneumatic motor.

[0038] In some implementations, the pneumatic actuation system further includes a manifold including at least one valve, the manifold coupled between a pump and the first and second pneumatic motors, wherein one or more pneumatic conduits are coupled between the manifold and the first and second pneumatic motors.

[0039] In some implementations, the at least one valve of the manifold is controllable to open or close based on instructions from the control system.

[0040] In some implementations, the needle insertion and tracking device further includes a plurality of optic encoders coupled to at least the first and second carriages, the plurality of optic encoders configured to track the motion of the first and second carriages in the first and second planes, respectively, and relay positional data about the first and second carriages to the control system.Brief Description of the Drawings

[0041] FIG. 1 A shows a system including an example device inside a magnetic resonance imaging machine (MRI), according to one implementation.

[0042] FIG. IB shows a system including an example device inside a magnetic resonance imaging machine (MRI), according to another implementation.

[0043] FIG. 2A shows an example MRI-compatible device along with a representative diagram of the alignment mechanism along a cross-sectional plane, according to one implementation.

[0044] FIG. 2B shows an enlarged version of the device of FIG. 2 A.

[0045] FIG. 2C shows a cutaway version of the device of FIG. 2A showing details of the actuation system and the components facilitating the movement, according to one implementation.

[0046] FIG. 2D shows a diagram of a circular implementation of the disclosed MRI- compatible device along with a top view and cross-sectional view, according to one implementation.

[0047] FIG. 2E shows a cutaway view of a circular implementation of the disclosed MRI-compatible device, according to one implementation.

[0048] FIG. 2F shows an example MRI-compatible device having an external needle guide, according to one implementation.

[0049] FIG. 2G shows a cutaway view of the device of FIG. 2F details of the actuation system and the components facilitating the movement, according to one implementation.

[0050] FIG. 2H shows an example tracking coil schematic, according to one implementation.

[0051] FIG. 21 shows one implementation of a tracking coil next to a penny for scale.

[0052] FIG. 2J shows an example imaging coil, according to one implementation.

[0053] FIG. 3 A shows a system diagram with connections between various elements of an example MRI-compatible device 200, according to one implementation.

[0054] FIGS. 3B shows graph of example anatomical liver motion in the superiorinferior direction, which contains both static (expiration) and dynamic (or inspiration) phases, according to one implementation.

[0055] FIG. 3C shows a cross-section view of a 3D-printed bellow actuator for needle insertion, according to one implementation.

[0056] FIG. 3D shows a full operation cycle of the needle insertion unit, wherein the top bellow is rigidly attached to the robot (pattern fill boxes) such that it only permits grasp motion, according to one implemenetation.

[0057] FIG. 4 provides a flowchart for the preparation and completion of a microwave ablation procedure (e.g., via a microwave ablation (MW A) needle), according to one implemenetation.

[0058] Fig. 5 shows an example diagram with the mechatronic hardware employed by the fabricated robot, according to one implemenetation.

[0059] FIG. 6 shows the inverse kinematics model for the fabricated robot on a point cloud, according to one implemenetation.

[0060] FIG. 7 shows an algorithm implementing the sequential moving strategy to address the hardware constraints.

[0061] Fig. 8 shows a graph of the x- and y-stage carriages actuating to their corresponding limits, providing a total of 36 data points, according to one implemenetation.

[0062] FIG. 9A shows a free-space bench-top experimental validation of the fabricated robot's guiding accuracy for needle placement.

[0063] FIG. 9B shows the sampling points within the robot workspace for the free- space accuracy test.

[0064] FIG. 10 shows a graph of the relation between position error and incline angle of the 234 data points.

[0065] FIG. 11 shows the magnetic resonance-conditionality results for the MRI phantom validation.

[0066] FIG. 12 shows a MRI phantom insertion experiment with the fabricated robot mounted above the gelatin phantom.

[0067] FIG. 13 shows the three needle insertions during the phantom validation experiment.Detailed Description

[0068] Some references, which may include various patents, patent applications, and publications, are cited in a reference list and discussed in the disclosure provided herein. The citation and / or discussion of such references is provided merely to clarify the description of the disclosed technology and is not an admission that any such reference is “prior art” to any aspects of the disclosed technology described herein. In terms of notation, “[n]” corresponds to the nth reference in the list. For example, [1] refers to the first reference in the list. All references cited and discussed in this specification are incorporated herein by reference in their entirety and to the same extent as if each reference was individually incorporated by reference.Example System

[0069] FIGS. 1 A and IB each show a diagram wherein a patient is disposed within a magnetic resonance imaging (MRI) machine with an exemplary device disposed on the patient’s abdomen (e.g., during use of the device).

[0070] FIG. 1 A shows a system 10 including a magnetic resonance imaging machine (MRI) 12, according to one implementation. The devices, systems, and methods of the present disclosure may be compatible with and / or implemented into an MRImachine / process. However, the system 10 of FIG. 1A and the MRI machine 12 therein are exemplary only, and other use cases and applications are contemplated by this disclosure.

[0071] The MRI machine 12 includes a movable patient table 14 on which a patient 16 lays. The patient 16 is shown within the tubular chamber of the MRI machine 12 (e.g., the imaging section of the MRI machine 12).

[0072] A device 20 is shown disposed on and / or attached to the abdomen of the patient 16. The device 20 may be a needle insertion and tracking device of the present disclosure (e.g., as shown and described with reference to FIG. 2A). The device 20 includes components and connections that are compatible with the MRI machine 12 (e.g., without metal or ferromagnetic elements). The device 20 may be coupled to the patient 16 via one or more straps and / or an adhesive material.

[0073] The device 20 may facilitate a procedure or a portion of a procedure. For example, the device 20 may facilitate the insertion of a needle, ablation tool, or other device that penetrates the abdomen and extends towards a target organ or tissue (e.g., the liver). Because the device 20 is MRI-compatible, the procedure can incorporate data from the MRI machine 12 while using the device 20 (e.g., for alignment and placement verification).

[0074] The device 20 includes a connection 22 extending from the device 20 to a control system 24. The connection 22 may include a fiber optic connection to transfer data between the device 20 and the control system 24. The connection 22 may include a conduit for pneumatics (e.g., pressurized air) between the device 20 and a pump of the control system 24. The control system 24 is configured to adjust and control the device 20 as it facilitates the insertion of the needle or ablation tool. The control system 24 is also configured to receive data about the device 20 from the device 20 (e.g., optic encoders on the device). The control system 24 is also configured to receive data from the MRI machine 12 (e.g., imaging data).

[0075] The control system 24 may include, or may be coupled to, a user interface such that a user (e.g., clinician) can receive feedback on the location of the needle or ablation tool and, thus, control the insertion of the needle or ablation tool. The control system 24 may receive control input from a user (e.g., a clinician) or an automated system in communication with the MRI machine 12.

[0076] FIG. IB shows a system 40 including a magnetic resonance imaging machine (MRI) 42, according to one implementation. The MRI machine 42 includes a movable patient table 44 on which a patient 46 lays. The patient 46 is shown within the tubular chamber of the MRI machine 42 (e.g., the imaging section of the MRI machine 42).

[0077] Another example device, device 50, is shown disposed on and / or attached to the abdomen of the patient 46 via adjustable straps 48. The device 50 may be a needle insertion and tracking device of the present disclosure (e.g., as shown and described with reference to FIG. 2E). The device 50 includes components and connections that are compatible with the MRI machine 42 (e.g., without metal or ferromagnetic elements).

[0078] The device 50 includes a connection 52 extending from the device 50 to a control system 54, similar to the connection 22 to the control system 24 of the device 20 of FIG. 1 A. The connection 52 may include a fiber optic connection to transfer data between the device 50 and the control system 54. The connection 52 may include a conduit for pneumatics (e.g., pressurized air) between the device 50 and a pump of the control system 54. The control system 54 is configured to adjust and control the device 50 as it facilitates the insertion of the needle or ablation tool. The control system 54 is also configured to receive data about the device 50 from the device 50 (e.g., optic encoders on the device). The control system 54 is also configured to receive data from the MRI machine 42 (e.g., imaging data).

[0079] The control system 54 may include, or may be coupled to, a user interface such that a user (e.g., clinician) can receive feedback on the location of the needle or ablation tool and, thus, control the insertion of the needle or ablation tool. For example, a clinician may remotely monitor the needle insertion and ablation topology under real-time MRI guidance. The control system 54 may receive control input from a user (e.g., a clinician) or an automated system in communication with the MRI machine 42.

[0080] As further described below with reference to FIG. 2H-2J, the device 50 includes one or both of a tracking coil and an imaging coil. For example, the devices and robots of the present disclosure (e.g., device 50) can seamlessly integrate with MRI imaging coil and tracking coils. A customized imaging coil allows for high-resolution and large-depth imaging of anatomy. A tracking coil will serve as the fiducials for registration and tracking purposes. These coil implementations streamline the workflow by eliminating the need for bulky commercial body coils and the time-consuming processes associated with the segmentation of the Gadolinium fiducial markers for registration and robot monitoring.Example Devices and Control Systems

[0081] FIGS. 2A-2C show an example device 200 (e.g., as represented by the device 20 of FIG. 1). FIG. 2A shows a device 200 along with a representative diagram of the alignment mechanism along a cross-sectional plane. However, it is understood that the device 200 provides for motion in more than one plane and more than one direction, and the diagram in FIG. 2A is representative of only a portion of the total combinations of motioncontemplated by the disclosure. FIG. 2B shows an enlarged version of the device 200, and FIG. 2C shows a cutaway version of the device 200 with specific mechanical elements and their interaction shown.

[0082] The device 200 is a needle insertion and tracking device 200 configured to guide a needle or ablation tool through the device 200 and towards a target tissue (e.g., a liver of a patient). The device 200 is generally rectangularly-shaped, having an outer housing 202 including a plurality of side walls. However, in other implementations, the device 200 may have a housing that is differently shaped (e.g., circular, square, oval, or irregular shaped). The side walls of the housing 202 include a first wall 202a, a second wall 202b opposite the first wall 202a, a third wall 202c, and a fourth wall 202d opposite the third wall 202c.

[0083] As shown, a top side 204 of the housing 202 is open such that no portion of the housing 202 extends over the top side 204 of the device 200. Similarly, a bottom side 206 opposite the top side 204 of the housing 202 is also open such that no portion of the housing 202 extends over the bottom side 206 of the device 200. However, in some implementations, the top side 204 and / or the bottom side 206 include a cover or wall defining one or more openings or access ports. Similarly, the sidewalls of the housing 202 may include one or more openings or access ports (e.g., for a pneumatic conduit, data transfer connection, or actuator connection).

[0084] The device 200 generally includes a first direction (shown as an x-direction in FIG. 2A) and a second direction (shown as a y-direction in FIG. 2A) substantially perpendicular to the first direction. See the coordinate system in FIG. 2B labeled “Robot Frame O” that shows example x-, y-, and z-directions. The first direction may include motion between the first wall 202a and the second wall 202b, including motion towards or away from the first wall 202a. The second direction may include motion between the third wall 202c and the fourth wall 202d, including motion towards or away from the third wall 202c.

[0085] The cross-sectional diagram in FIG. 2A is taken along the second direction (e.g., y-direction), such that the third wall 202c and the fourth wall 202d are provided on either side of the diagram. However, the diagram and the information displayed therein apply to other directions (e.g., the x-direction or a polar / circular direction implementation).

[0086] The device 200 includes a first carriage 210 and a second carriage 220. The first carriage 210 includes a first guide 212 defined through a portion of the first carriage 210. The second carriage 220 includes a second guide 222 defined through a portion of the second carriage 220. A needle guide 230 is coupled to the first guide 212 of the first carriage 210 (e.g., via a rotatable plate and / or bearing) and extends to the second guide 222 of the secondcarriage 220. The needle guide 230 is configured for accepting a needle or microwave ablation tool and guiding the insertion of the needle or microwave ablation tool into a target location, as described below.

[0087] Each of the first carriage 210 and the second carriage 220 are movable within the cavity defined by housing 202 in one or more directions. Specifically, each of the first carriage 210 and the second carriage 220 are independently movable in their respective planes such that the needle guide 230 extending between the first guide 212 and the second guide 222 is adjustable to a variety of angles / vectors with respect to the device 200 and / or a target tissue of a patient.

[0088] The first carriage 210 and the first guide 212 thereon is movable in a first plane 214. The first carriage 210 is coupled to and movable along a first set of guide rods 240 that extend in the second direction (e.g., the y-direction). The first set of guide rods 240 are coupled on either end of the first set of guide rods 240 to a second and third set of guide rods extending in the first direction (e.g., the x-direction). The second set of guide rods 242 extends between the first wall 202a and the second wall 202b. A secondary carriage 218a on the second set of guide rods 242 is coupled to an end of the first set of guide rods 240. The third set of guide rods 244 extends between the first wall 202a and the second wall 202b. A secondary carriage 218b on the third set of guide rods 244 is coupled to an opposite end of the first set of guide rods 240. Therefore, the first carriage 210 is movable along the first direction (e.g., the x-direction) via movement of the entire first set of guide rods 240 in the first direction (e.g., the x-direction) along the second and third sets of guide rods 242, 244 (e.g., facilitated by bearings on the secondary carriages 218a, 218b). The first carriage 210 is moveable along the second direction (e.g., the y-direction) via movement of the first carriage 210 along the first set of guide rods 240 (e.g., facilitated by bearings on the first carriage 210).

[0089] In other implementations, the number and orientation of the guide rods may be a different combination or orientation. For example, in other implementations, only one guide rod may be used for a particular direction or motion or a particular connection point. In other implementations, the bearings, carriages, and other slidable elements may include additional or alternative components that allow for linear motion. In some implementations, the device and elements therein are capable of moving and aligning the needle guide with 4 degrees-of- freedom (DOF) motion (e.g., two translation DOF and two rotational DOF).

[0090] The second carriage 220 includes a similar setup to the guide rods of the first carriage 210. The second carriage 220 is movable in a second plane 224 substantially parallelto, and spaced apart from, the first plane 214. Similar to the first carriage 210, the second carriage 220 is movable in the second direction (e.g., the y-direction) via movement of the second carriage 220 along a set of guide rods extending in the same direction. Similar to the first carriage 210, the second carriage 220 is moveable in the first direction (e.g., the x- direction) via movement of a set of guide rods along secondary carriages 218a, 218b coupled to additional sets of guide rods that extend between the first wall 202a and the second wall 202b.

[0091] The device 200 includes a plurality of actuators (e.g., pneumatic motors or piezoelectric actuators) configured to move the first carriage 210 and the second carriage 220 to a desired location. The device 200 shown in FIGS. 2A-2C includes four individual pneumatic motors; however, in other implementations, a different number of pneumatic motors may be used. In other implementations, the plurality of actuators includes a plurality of piezoelectric actuators each individually controllable to move on or both of the first and second carriages in a desired direction.

[0092] FIG. 2C shows details of the actuation system (e.g., the pneumatic actuation system) and the components facilitating the movement of the first carriage 210. However, it is understood that similar, identical, or mirrored components are used for movement of the second carriage 220.

[0093] For movement in the second direction (e.g., the y-direction), the first carriage 210 is disposed on the first set of guide rods 240 via one or more spherical bearings. The first carriage 210 includes a lead screw opening 216 through which a first lead screw 270 extends. The first lead screw 270 is coupled to a set of bevel gears 272 to change the angle and / or direction of motion transfer. The set of bevel gears 272 is coupled to a set of spur gears 274 (e.g., via a square shaft). The set of spur gears 274 is coupled to a first pneumatic motor 276.

[0094] The first pneumatic motor 276 drives rotation of the set of spur gears 274, which then drives rotation of the set of bevel gears 272. Rotation of the set of bevel gears 272 then rotates the first lead screw 270. Rotation of the first lead screw 270 within the opening 216 of the first carriage 210 causes the first carriage 210 to move along the second direction (e.g., y-direction). Therefore, activation of the first pneumatic motor 276 to rotation in one direction (or an opposite direction) drives the movement of the first carriage 210 in a direction (or an opposite direction) along the first set of guide rods 240.

[0095] The system of gears in between the first pneumatic motor 276 and the first carriage 210 allow for gear reduction - increasing torque and accuracy of movement while decreasing speed. In some implementations, a gearbox may be coupled to the first pneumaticmotor. In other implementations, the pneumatic motor may be coupled directly to the lead screw.

[0096] A second pneumatic motor 280 is provided adjacent to the first pneumatic motor 276. The second pneumatic motor 280 facilitates the movement of the first carriage 210 in the first direction (e.g., the x-direction). Specifically, the second pneumatic motor 280 is coupled to a timing belt 282 configured to process or move along a timing belt path when the shaft of the second pneumatic motor 280 rotates. The timing belt 282 extends to a second lead screw 284 and a third lead screw 286 via a gear / spool having teeth matching that of the timing belt.

[0097] The lead screw 284 extends through a portion of the secondary carriage 218a coupled to the second set of guide rods 242. The third lead screw 286 extends through a portion of the secondary carriage 218b coupled to the third set of guide rods 244. Similar to the first lead screw 270, rotation of the second lead screw 284 and the third lead screw 286 causes the respective secondary carriage 218a and secondary carriage 218b to translate in the first direction (e.g., the x-direction) based on rotation of the second pneumatic motor 280. The timing belt 282 ensures that the secondary carriage 218a and the secondary carriage 218b translate the same amount.

[0098] As shown in FIG. 2B, the device 200 further includes encoders 296 (e.g., optic encoders) coupled to a portion of an actuator or a guide rod. The encoders 296 are configured to track the motion of the carriages 210, 220 and / or rotation of the pneumatic motors 276, 280. The encoders 296 collect motion and displacement data concerning the device 200 and relay the displacement data back a control system coupled to the device 200. Such displacement data may be used to verify the location of the carriages 210, 220 and adjust their position as needed.

[0099] As shown in the diagram in FIG. 2A, a vector 250 is defined by (i) a longitudinal axis of the needle guide 230, and (ii) a line extending between the first guide 212 and the second guide 222. The vector 250 extends from outside of the top side 204 of the housing 202, through the device 200, and outside of the bottom side 206 of the housing 202. The vector 250 further extends through an abdomen 260 of a patient and into a target tissue 262 (e.g., a liver).

[0100] The vector 250 represents the pathway for insertion of a tool (e.g., a needle, such as a microwave ablation needle or similar device) into the target tissue 262. For example, once the device 200 is in place on the abdomen 260 of the patient, the vector 250 can be adjusted to coincide with the target tissue 262. For example, a patient in an MRImachine may have the device 200 coupled thereto, wherein imaging from the MRI machine can guide insertion of the needle or ablation tool.

[0101] The first carriage 210 and / or the second carriage 220 are movable to adjust the vector 250. For example, if the vector 250 is misaligned with respect to the target tissue 262, one or both of the first carriage 210 and the second carriage 220 may be adjusted to change the angle of the needle guide 230 and the vector 250 corresponding thereto. Such a change may occur during insertion of the tool or needle due to changes in the insertion pathway (e.g., breathing or other small adjustments). A clinician can view the insertion pathway and location of the tool via the MRI machine, and they may adjust the vector 250 as needed. In other implementations, an automated system may perform the adjustments. A control system is coupled to the device 200 to facilitate data collection and / or actuation of the carriage movement, as elsewhere described.

[0102] Circular Robotic Device

[0103] FIG. 2D shows another implementation of the disclosed device, shown as 200b. The device 200b is a circular alternative to the rectangular shaped device 200 previously presented. FIG. 2D is a generic diagram of a circular device 200b, and other implementations of a circular device are contemplated by this disclosure. The device 200b includes the first carriage 210b (e.g., upper carriage) and the second carriage 220b (e.g., lower carriage) disposed on a set of guide rods, similar to the carriages 210, 220 of the device 200. However, the guide rods of the device 200b includes a radial guide rod 290 and a circumferential guide rod 292.

[0104] Thus, each of the first carriage 210b and the second carriage 220b move along their respective set of the radial guide rod 290 and the circumferential guide rod 292 - in their respective planes - to adjust the position of the first carriage 210b and the second carriage 220b. Similar to the device 200, movement of the carriages 210b, 220b also moves the first guide 212b and the second guide 222b, which moves the needle guide 230b and the associated vector 250.

[0105] In other implementations, the device of the present disclosure may include a hemispherical-shaped device such that the carriages move in polar and azimuthal directions about a center point.

[0106] FIG. 2E shows an example implementation of the device 200b, shown as device 200c. The device 200c is a circular device having the basic structure and function of the device 200b of FIG. 2D. The device 200c is an MRI-safe needle placement robot that employs two identical ring-shaped gear stages 201c, 203c, stacked together for 4-DoF needleposition and orientation control. For example, the device 200c includes a first carriage 210c supported by the gear stage 201c and a second carriage 220c supported by the gear stage 203c, each carriage engaged with the needle guide 230c via a gimbal joint.

[0107] The motion of each carriage 210c, 220c, is achieved via the interaction of the gears 201c, 203c with pinions, traversed by a lead screw, that results in axial rotation and translation in the stage plane. Customized gimbal joints are mounted on the carriages 210c, 220c to provide up to ±45° incline angle control. Two sets of MRI-safe motors and pistons will transfer the motor motion to the desired gear stages 201c, 203 c via the anti -backlash gear transmission units. The gear-based actuation and transmission design will address the potential slipping motion found in the belt transmissions. The device 200c ensures sub-mm motion accuracy, provides increased workspace, facilitates a larger range of needle tip coverage, and still maintains a compact profile. In some implementations, at the robot base, a ring-shaped adaptor that can rigidly integrate with the lower stage and house the MRI coils is included.

[0108] External Needle Robotic Device

[0109] FIG. 2F and FIG. 2G show another implementation of an MRI-compatible device as disclosed herein. FIGS. 2F-2G show a device 200d having an overall rectangular shape with two cartesian stages, similar to the device 200 of FIGS. 2A-2C. Each cartesian stage supports a carriage (e.g., an upper carriage 210d and a lower carriage 220d). The device 200d externalizes the needle guide 23 Od such that the movement and actuation components are disposed internally to the housing 202d while the needle guide 230d is external to the housing 202d. The device 200d has a smaller profile compared to other robots of this disclosure, making it more suited for the sanitation and reusability requirements present in a surgical environment. Decreasing the robot profile leads to easier use and compatibility with various MRI scanners and their varying bore size and similarly allows for a more diverse array of patients. In some examples, the device 200d has a footprint smaller than 210 x 176 x 99 mm3while maintaining a workspace of at least 1,925 mm2.

[0110] The externalized design also makes the robot / device 200d more accessible for the surgical environment for sanitation. For example, because the needle pathing is external from the main mechanical components of the device 200d, the mechanical components are insulated by a coherent outer shell or housing 202d. The internal mechanical components are thus more easily covered by the coverings used for surgical instruments. Additionally, the components that meet and interact with the needle are easily replaceable since they are separate from the internal mechanical components.

[0111] In the device 200d, each Cartesian platform has carriage 210d, 220d that supports mounting of two linear actuators (Linear 20N LT20, PiezoMotor, Sweden) which allow each platform to provide 2 DoF to the system. The linear actuator mounted perpendicular to the carriage is considered the x-axis and the carriage with carbon fiber support rails is considered the y-axis. Each carriage is supported by two 5 mm carbon fiber rods and contains bushings for smooth translation (2706T513, McMaster-Carr, USA). Each Cartesian platform supports a custom-designed ball joint 298 that supports a needle guide 230d. The ball joint 298 allows for angles up to 54° and is easily manufactured to allow for easy replacement between surgeries. The joint 298 is supported by two 3 mm carbon fiber support shafts to prevent off-axis torque from impacting the performance of the linear actuators as well as prevent stress on the ceramic drive rod each linear actuator uses. Thus, similar to the device 200 of FIGS. 2A-2C, the device 200d of FIGS. 2F-2G provides movement of an upper and lower portion of the needle guide 230d to adjust the vector of the needle guide, facilitating proper needle / ablation tool insertion.

[0112] The outer shell or housing 202d of the robot 200d allows for easy setting and replacement of each platform while maintaining a coherent, smooth casing. Each platform has 3 pairs of contacts for each carriage to be set into place. Two for the carbon fiber support shafts and one for a fitting of the drive rod for the x-axis linear actuator of each carriage. After placement, the carriages are secured into place through the screw setting of each of the support shafts.

[0113] Due to the high resolution of the linear actuators (step size of 4.5 mm) and trying to maximize the workspace while limiting the robot footprint, encoders were not used in the device 200d. Rather, limit switches (RPI-221, ROHM Semi-conductor, Japan) were implemented to home the robot before movement to each position. The limit switches were selected due to their low profile and demonstrated functionality in previous literature. They are included for each axis on the carriage. Note that the x-axis limit switches are mounted on the outer shell, while the y-axis limit switches move with the carriage.

[0114] To maintain MR-conditionality, none of the materials used during the fabrication of the device 200d were ferromagnetic. The carriages, outer shell, limit switch mounts, and bearings were made from acrylonitrile butadiene styrene (ABS) using a fused deposition modeling (FDM) printer (F170, Stratasys, US). Purchased parts including carbon fiber rods, nylon bushings and the limit switches were similarly chosen due to their MR conditionality. Completion of the discussed design yielded a robot whose core footprint was 110 x 135 x 80 mm3with an additional external footprint for the needle workspace and strapmounts for patient mounting. Due to the material usage and low profile, the robot was also very light, with the full weight of the system being 404 g. This limited profile and weight allows for the robot to be used for a variety of abdominal procedures, increases patient comfort during the procedure, and expands the accessible patient population to include pediatric patients.

[0115] Example Robotic System with Integrated Tracking Coil and Imaging Coil

[0116] In many implementations, tracking coils and / or imaging coils may be implemented in the disclosed robot (e.g., any one of the devices 200, 200b, 200c, or 200d). A tracking coil may be used to track the robots coordinates within the MRI machine. The tracking coil also allows for high-resolution and large-depth imaging of anatomy. The tracking coil can serve as the fiducials for registration and tracking purposes. FIG. 2H shows an example tracking coil schematic, and FIG. 21 shows one implementation of the coil next to a penny for scale.

[0117] The tracking coil of FIG. 2H includes a solenoid inductor, a capacitor, and a micro-sample cell, tuned to resonate at 128MHz. The tracking coil can be localized at 27Hz with an accuracy of 600um and precision of 20um in all directions. The RF tracking coil can be used to replace the conventional fiducial markers mounted on the robot base, allowing accurate and fast coordinate frame registration and robot motion tracking.

[0118] According to other implementations, the tracking coil(s) include a multiturn inductor with a spherical sample cell and a tuning capacitor to achieve resonance at 63.8 MHz for 1.5T. A ~1.5 mm OD spherical glass sample cell filled with MR contrast agent is placed in the solenoid. The sample cell is sealed with epoxy, and the marker is enclosed in shrink wrap to make an insulated capsule -5 mm3in size. The movement of the robot in the MRI frame can then be tracked in real-time (-25-30 Hz) using a linear navigator sequence interleaved with the primary MR imaging sequence.

[0119] An imaging coil is also disclosed, distinct from the tracking coil. An example imaging coil is shown in FIG. 2J. The imaging coil includes a loop receive-only RF coil (resonance frequency of 64MHz) which includes copper wire. In some implementations, a coil diameter of 17cm is used to provide a balance between signal -to-noise ratio and penetration depth (sensitivity coverage) in the region of interest. The dimension of the coil also allows it to be incorporated into the robot seamlessly. Redundant safety measures, including passive detuning circuit and RF fuse, are used to prevent interactions between the body transmit coil and the receive loop coil that could cause concerns for the safety of the patients and the coil. A connector interface box with BNC female connectors to allow the coilto be connected to the scanner (Philips Ingenia 1.5T), where the final experiments will be performed.Example Control System

[0120] FIG. 3A shows a system 300 with the connections between various elements of the present disclosure including, for example, the device 200 of FIGS. 2A-2C and the system 10 of FIG. 1 A. The system 300 includes an MRI machine 301 (e.g., the MRI machine 12 of FIG. 1A) including an imaging system 302 coupled to the MRI machine 301. The imaging system 302 is configured to gather, interpret, and output data from the MRI machine 301. For example, the imaging system 302 is configured to output images of a patient and a target tissue to an output device, a display, and / or a user interface. The device 200 is disposed within the MRI machine 301, similar to the setup shown in FIG. 1 A.

[0121] A control system 303 is disposed adjacent to the MRI machine 301. The control system 303 is coupled to and / or in communication with the imaging system 302 (e.g., to receive imaging data from the MRI machine 301). The control system 303 is also coupled to and / or in communication with the device 200 via a connection line 304. The connection line 304 may include a fiber optic cable or any other MRI-compatible data link between the device 200 and the control system 303 (e.g., coupled to the optical encoders of the device 200).

[0122] The device 200 is optionally coupled to a manifold 305 that includes a plurality of controllable valves. A pump 306 is coupled to the manifold 305 to provide a pressurized fluid (e.g., compressed air). However, in implementations wherein the actuation system of the device 200 is a piezoelectric system, the manifold 305 and the pump 306 are not included.

[0123] The manifold 305 includes, for example, a number of valves matching the number of pneumatic motors within the device 200. Thus, one or more fluid conduits 307 are coupled between the device 200 (e.g., the pneumatic motors thereof) and the manifold 305 (e.g., and the individual valves thereof). The one or more conduits 307 may include as many separate conduits as the number of pneumatic motors. Each of the one or more conduits 307 are configured to deliver compressed air from the manifold 306 to a pneumatic motor of the device 200.

[0124] The control system 303 is in electrical communication with each of the controllable valves of the manifold 305 and the pump 306. The control system 303 is configured to turn on and off the pump 306 as needed. The control system 303 is configured to open or close each of the controllable valves of the manifold 305 as needed.

[0125] As further described with reference to the flowchart 400 of FIG. 4, the control system 303 can selectively actuate various elements of the system 300 to facilitate a needle insertion procedure (e.g., an ablation needle insertion procedure into a patient’s liver). For example, once the device 200 is coupled to the patient (as in FIG. 1 A), the control system 303 can operate to adjust the carriages and the needle guide of the device based on information from the MRI machine 301. Data from the imaging system 302 (or preconfigured instructions in the control system 303) can identify a target tissue of the patient with respect to the location of the device 200. Then, the control system 303 can move the carriages of the device 200 by selectively opening and closing valves of the manifold 305 to actuate pneumatic motors of the device - ultimately adjusting the vector of the needle guide. The imaging system 302 may verify the vector of the needle guide and / or the location of the needle once inserted into the device 200. Data from the optic encoders of the device 200 that is sent to the control system 303 can also verify the location of the carriages and the vector of the needle guide.

[0126] As the needle or ablation tool is inserted into the patient, the MRI machine 301 continuously feeds data from the imaging system 302 to the control system 303. The control system 303 may include a user interface 310 configured to display imaging data from the 302. Such a user interface 310 can show the location of the needle or ablation tool within the patient. A clinician (or an automated system) can interpret the imaging data and adjust (i) the insertion distance / velocity of the needle and / or (ii) the vector of the needle guide via adjustment of the manifold 305 and / or the pump 306.Needle Insertion Device, System, and Method

[0127] In some implementations, the needle insertion is performed in a stepwise manner based on a respiratory cycle of the patient. FIGS. 3B-3D show an example of stepwise needle insertion unit design and control. Specifically, FIG. 3B shows example anatomical liver motion in the superior-inferior direction, which contains both static (expiration) and dynamic (or inspiration) phases. FIG. 3C shows a cross-section view of a 3D-printed bellow actuator for needle insertion. FIG. 3D shows a full operation cycle of the needle insertion unit. The top below is rigidly attached to the robot (pattern fill boxes) such that it only permits grasp motion.

[0128] With respect to the needle insertion device, one goal is to minimize the overall dimension such that it can be placed within two gimbal joints, and one constraint is to maintain adequate insertion force (>2N) for tissue penetration. A study developed and validated the analytical model to estimate the grasping and insertion force. The study alsoapplied the particle swarm optimization method to search the optimal parameters (such as bellow length, diameter, wall thickness, etc.) to minimize our objective function.

[0129] The developed model and control framework provides that one full step of the needle insertion unit can be accomplished when the liver has neglectable movement (static phase) and pause the insertion when the liver tends to move significantly (dynamic phase, see Fig. 3B). Using this motion compensation strategy, the periodically moving target can be approximated to an “immobilized” point with this move-pause insertion protocol, which can significantly compensate for the respiration-induced motion. A lumped parameter method may be used to develop the dynamic model for both the needle insertion unit and long air hose, and then apply the nonlinear controller, such as the sliding mode controller, to achieve the desired fast and accurate needle insertion control.Example Method

[0130] FIG. 4 provides a flowchart 400 for the preparation and completion of a microwave ablation procedure (e.g., via a microwave ablation (MW A) needle). First, at step 402, the method / flowchart includes providing a needle insertion and tracking device (e.g., the device 200), and it further includes attaching the device 200 to the patient. For example, one or more straps may be used to secure the device 200 to the patient as they move into an MRI machine. Then, at step 404, a microwave ablation needle is inserted into a portion of the device (e.g., attached to a distal opening of the device but not inserted into the cavity of the device nor the patient). In this configuration, the ablation needle is ready to be inserted into the patient. At step 406, the patient and the device attached thereto are inserted into the MRI machine (e.g., the imaging portion).

[0131] At step 408, a target point and an entry point of the patient are selected. The target point is a point on a target tissue (e.g., a tumor or other tissue to be ablated or treated). The entry point is a point on the patient’s skin where the needle will penetrate and insert into the abdomen. The selection of the target point and the entry point is aided by the MRI machine’s imaging, which can show the target tissue in relation to the device. The selection of the target point and the entry point in step 408 may be completed by a clinician (e.g., a doctor or technician who can monitor the progress of the needle). In other implementations, the selection of points in step 408 may be completed by an automated system (e.g., a medical robot and / or software program).

[0132] At step 410, the device is adjusted (e.g., via actuators and a control system coupled thereto) to orient the needle guide. Specifically, a vector of the needle guide is aligned with the entry point and the target point of the patient. The alignment of the needleguide may be performed entirely manually, entirely autonomously, or a combination of manual and automatic input. For example, the device and control system may automatically align the needle guide as best as possible, and a clinician may verify and / or adjust the vector as needed.

[0133] At step 412, the needle (e.g., MWA needle) is inserted into the patient at the entry point through the needle guide of the device. The insertion process may be timed (either manually or automatically) based on the respiration cycle of the patient. Additionally, as the needle is inserted into the patient, the MRI imaging system continuously provides data on the location of the needle in the patient. The angle and / or distance of insertion of the needle may be adjusted, either manually or automatically, based on feedback from the MRI imaging data.

[0134] The location of the needle is verified in step 414 to ensure that the needle tip is accurately placed with respect to the target tissue. If there is a discrepancy between the expected location and the actual location, the needle may be adjusted. Then, at step 416, the MWA procedure is performed, either automatically, manually, or a by combination of human and machine input.Experimental Results and Additional Examples

[0135] A study was conducted to develop the exemplary magnetic resonance-guided abdominal intervention robot configured to operate in closed-bore magnetic resonance scanners for accurate needle guidance.

[0136] This study developed a compact, pneumatic motor driven, MR-conditional body-mounted robot for accurate needle guidance during MR-guided percutaneous interventions. The robot consisted of two stacked Cartesian stages that manipulated a needle guide. Each stage provided two degrees of freedom, equipping the needle guide with a total of 4 controllable degrees of freedom. The insertion was controlled manually using a surgeon- in-loop approach, while each controllable axis of the Cartesian stage was actuated using an MR-safe pneumatic motor with a large gear reduction. All electronics used for control were decoupled from the MRI via pneumatic and fiber optic transmission modalities.

[0137] The study focused on the quantification in free-space and MRI phantom trials. The system was first evaluated at the axis level. Despite the high latency of the pneumatic actuating system due to pneumatic transmission line dynamics, and the simplicity of the bang-bang control algorithm, the system yielded an average axis movement accuracy of 0.18 ± 0.13 mm, primarily due to the large reduction and damping associated with the plastic gearbox and translational lead screws. After evaluation on the axis level, system level evaluations were performed. Despite the needle length, which amplifies the axis-level error,the needle tip error remained below 5 mm (2.6 ± 1.3 mm at an insertion depth of 80 mm) in both the free-space and MRI phantom experiments. Additionally, the angular error remained below 5°. The maximum observed axis error was 0.5 mm. If the axes exhibited an error with the worst case scenario (two carriages with a 0.5 mm position deviation toward opposite directions along the diagonal), this would suggest an angular error of 1.8°, which was only a fraction of the free-space (3.9° ± 1.2°) and MRI (2.1° ± 1.4°) experimental angular error. This suggests there are other errors beyond those defined by the axis error. Likely causes can include the registration error of the system, fabrication errors associated with angular play in the spherical joint and the linear rail, and free-space between the needle guide and the needle.

[0138] The robot in this study served as a proof-of-concept for the MR-guided MWA treatment of HCC and other abdominal interventions. Its lightweight design and MR- guided implementation also promoted its potential use in pediatric patients. While the needle tip error below 4 mm met the requirements for most HCC MWA procedures the robot workspace was constrained by a maximum insertion angle of 30° and hence led to a limited selection of possible needle paths toward the target. This limitation was primarily imposed by the relatively large spacing between the two Cartesian stages of the robot and the limited incline angle provided by the spherical bearings. Another limitation of the study was the cost associated with MRI-guided experiments, which precluded the collection of statistically significant results in this early stage.

[0139] While the goal is to validate the proof-of-concept here, future studies may focus on improving the robot targeting accuracy, enhancing the workspace, optimizing the robot dimension, and extensive validations inside MRI environments. To achieve these goals, future studies may implement dynamic MRI image feedback

[0043] , replace the pneumatic valves with directional-proportional control valves

[0038] , and utilize fabrication methods with higher accuracy, which may further improve the accuracy of needle insertions and streamline the procedure workflow.

[0140] Fabricated robot. The fabricated robot of this example implementation includes the following characteristics and capabilities: (1) the robot has 4 actively controlled degrees of freedom (DoFs) to facilitate effective control of the needle insertion vector, (2) the robot is magnetic resonance-conditional (MR-conditional) and all its components are nonferromagnetic to avoid interference with the magnetic field, and (3) the robot design ensures seamless employment with the magnetic resonance imaging (MRI) body coils and provide sufficient space for physicians to perform needle insertion.

[0141] FIGS. 2B and 2C show the design of the fabricated robot. Specifically, FIG. 2B shows the fabricated robot including supporting plates, a transmission system, an actuating system (including pneumatic motors, optical encoders, and limit switches), and a needle guide. FIG. 2C shows an upper motorized Cartesian stage employed by the actuating system of the fabricated robot.

[0142] As shown in FIG. 2C, the fabricated robot includes two primary subsystems: (i) a lower motorized Cartesian stage, and (ii) an upper motorized Cartesian stage. Each Cartesian stage possessed a carriage that has 2-DoF, providing linear translation motion capability in both the x- and y-axis directions of the system coordinate frame. The stage corresponding to displacements in the x-axis direction is referred to as the x-stage and the stage corresponding to displacements in the y-axis direction is referred to as the y-stage.

[0143] Two spherical joints (e.g., flange bearing and spherical ball guide EFSM-06, igus, Germany) were embedded within both carriages. As the carriages moved relative to one another, a needle guide retained by the two spherical joints adjusted the needle insertion vector, providing 4 actively controlled DoFs for the needle pose. The needle guide was solely connected to the upper carriage, providing a relative sliding motion between the needle guide and the lower carriage. Feedback of the displacement of each carriage was obtained via MR- conditional encoders, attached to the x- and y-stage, and fiber optical limit switches.

[0144] The upper Cartesian stage shown in FIG. 2C was substantially identical to the lower Cartesian stage. Each axis stage of the upper Cartesian stage was actuated by a single, MR-safe pneumatic motor

[0033] ,

[0034] , Each major axis of the Cartesian stage in FIG. 2C was parallel to either the x-axis or y-axis of the robot coordinate frame attached at point O.

[0145] The x-stage had two carriers that supported the y-stage. The two carriers defining they-stage’s position were displaced using two translational lead screws (e.g., lead screw 1 A and IB in FIG. 2C). These lead screws were actuated by a single motor (i.e., motor 1) using a belt and pulley system, as depicted in FIG. 2C. They-stage was responsible for directly displacing the carriage retaining the spherical joint. This displacement was also performed using a translational lead screw (i.e., lead screw 2 in FIG. 2C). However, to avoid the complexity of displacing they-stage motor (i.e., motor 2 in FIG. 2C) with the change in displacement of they-stage, the study implemented a bevel gear mechanism with a square shaft and spur gear transmission, wherein motor 2 rotated a square shaft via a spur gear system. The square shaft permitted passive translational displacements with they-stage but linked the rotational displacements of motor 2 with the rotary displacements of lead screw 2.As the spur gear rotated, the square shaft rotated, which in turn rotated lead screw 2, moving the carrier in the ’-axis direction.

[0146] To ensure MR-conditionality, all associated components were made of plastic, glass, rubber, or carbon fiber. The supporting plates were printed using polylactic acid (PLA) with a fused deposition modeling (FDM) printer (e.g., F170, Stratasys, USA). The smaller custom-designed parts, such as the bevel gears, timing belt pulleys, pneumatic motors, etc., were printed using photosensitive resins with a stereolithography printer (e.g., Form 3B+, FormLabs, USA). The commercially available parts, such as the carbon fiber rods (which served as the linear rails) and plastic bearings, were selected to ensure they were all MR- conditional. Using the compact robot design shown in Fig. 4, along with non-metallic materials, the overall volumetric dimension of the robot was 210 * 176 * 99 mm3with a total mass of 860g. This fabricated robot was lighter than the similar 4-DoF MR-conditional bodymounted robot presented in

[0031] (mass of 1.5kg). The small size and weight provided potential clinical adoption for general percutaneous abdomen interventions in pediatric patients, such as liver biopsy

[0035] or kidney biopsy

[0036] ,

[0147] Mechatronic hardware. Fig. 5 shows the mechatronic hardware employed by the fabricated robot. The study divided the mechatronic hardware into three domains: (1) electronic, (2) pneumatic, and (3) fiber optic.

[0148] As shown in FIG. 5, in the electronic domain, a control interface developed in MATLAB converted high-level, surgeon-in-loop commands (entry position and target position) into low-level commands (target axes positions) based on inverse kinematics and coordinate frame registration. The high-level commands ensured the motor position commands and sequences avoid binding of the spherical joints. The low-level commands were communicated to a motion controller (e.g., DMC-4163, Galil, USA) through a Local Area Network (LAN) connection. The motion controller was used to (i) send voltage signals to a custom-designed valve drive circuit that activates 3-way 3-position solenoid valves (e.g., 6425K18, McMaster, USA), (ii) receive feedback signals from the MR-conditional quadrature encoders, and (iii) monitor the four limit switch optical fiber receivers. The motion controller, valve drive circuit, and the solenoid valves were all housed within a custom-designed control box (not shown).

[0149] As shown in FilG. 5, in the pneumatic domain, the solenoid valves directed flow from a pneumatic pump to the pneumatic motor. Transmission of the pneumatic fluid was facilitated by 1 / 4” pneumatic transmission lines (PTL) (e.g., 5648K74, McMaster, USA). The PTL was connected to the control box and the robot by custom-designedconnectors that used O-ring style static seals

[0037] , The PTL and its connectors were fed through the wave-guide between the magnetic resonance-control (MR-control) room and the magnetic resonance (MR) imaging suite to decouple the electronic domain from the magnetic resonance imaging (MRI). The pneumatic motors transferred the angular momentum of the pneumatic flow into a torque applied to the translational lead screws. In a similar manner, as shown in FIG. 5, the fiber optic domain transferred light to the fiber optical limit switches to monitor the motion of the translational lead screws.

[0150] Control Operation. The study implemented a bang-bang control approach on the Galil motion controller based on low-level commands (desired axes positions) and the axes states. The study used this implementation in lieu of a standard proportional-integral- derivative (PID) control algorithm due to the straightfoforward yet robust mode of operation of the 3 -way 3 -position solenoid valves. Although more comprehensive control algorithms can be used to control the motor for dynamic conditions

[0038] , this control strategy was sufficient for set-point tracking in this clinical application, providing a typical carriage accuracy of < 0.5 mm. This level of accuracy was obtainable through the high reduction ratio in the actuating system, resulting in a highly damped actuating system and a low carriage translational speed ( < 5 mm / s). This low speed helped minimize carriage overshoot caused by its inertia and any remaining compressed air in the PTL

[0038] after the carriage position error was within the threshold (0.3 mm for the x-axis and 0.6 mm for the j’-axis) that turned off the pneumatic valves.

[0151] Robot modeling. FIG. 6 shows the inverse kinematics model for the fabricated robot on a point cloud. As shown in FIG. 6, the desired upper carriage, Pu=(xu, yu, zu), and lower carriage, Pi =(xi, yi, zi), positions in the robot frame, Ox-,-, can be obtained based on the desired entry point, Pe=(xe, ze), and the target point, Prd t, yt, zt). The entry point and target point coordinates were obtained from the MR coordinate system and transformed into the robot coordinate frame using rigid-point registration between the MR coordinate frame and the robot frame. Based on the geometric relationship, the desired position of the carriages can be calculated using Equation Set 1.(Eq. Set 1)

[0152] In Equation Set 1, zu= -36.5 mm and zi =-82.2 mm are the z-axis coordinates for the two spherical bearings in the robot frame, which were defined during the robot hardware design process.

[0153] Robot workspace analysis and sequential moving strategy. The robot workspace was dominated by two factors: the feasible travel distance of the carriages, defined by a 55 mm by 30 mm rectangle, and the joint limits of the spherical joints on the carriages, which had a maximum angle of inclination, 0, of 30°. These constraints resulted in a reachable workspace in the shape of a frustum, as indicated by the point cloud shown in FIG. 6. To assess the liver volume encompassed by the robot’s workspace, the workspace point cloud was superimposed onto a liver model. The liver model was appropriately offset from the workspace by a distance of 25mm, corresponding to the thickness of the abdominal wall

[0039] , Subsequently, the intersection of the workspace with the liver body size was quantified, revealing that the reachable region within the liver occupies 70% of the liver volume (1147ml

[0040] ).

[0154] In addition to analyzing the workspace of the robot, the study developed a sequential moving strategy that prevented violation of the physical constraints mentioned above during robot motion. This strategy ensured that the angle of inclination of the insertion vector that connected both upper and lower carriages was within the 30° operational range. Additionally, during the practical implementation of the robot, only one pneumatic motor can be effectively actuated at any given time due to the limited volumetric capacity and recharge rate of the compressor.

[0155] FIG. 7 shows an algorithm (i.e., algorithm 700) implementing the sequential moving strategy to address the hardware constraints. This algorithm coordinates the independent movement of each of the four axes in sequence to ensure the incline angle of the guide stays within its limit. As shown in FIG. 7, the carriages were sequentially moved using the low-level motion controller and the bang-bang control strategy along the x- and y- directions in every iteration of the loop. During each iteration, the carriage with a larger absolute position error was chosen to be moved by a maximum amount of 5 mm toward the target position. Thus, algorithm 700 ensured that the carriages were safely guided to the desired position without violating hardware constraints. It should be noted that a larger compressor may be used in other implementations to enable simultaneous multi-axis control.

[0156] Clinical workflow. The study developed the fabricated robot to be capable of providing position and orientation control of the step insertion unit

[0027] that enabled activeneedle insertion within a closed-bore MRI under real-time MRI guidance. Table 1 shows a surgical workflow of a needle insertion process performed by the fabricated robot.Table 1

[0157] Prior to the needle insertion process, the clinician confirmed the robot location and the treatment trajectory. This surgeon-in-loop control strategy (i.e., clinical workflow) provided a safe needle deployment without damaging critical regions.

[0158] Free -space axis position accuracy validation. Prior to the system level evaluations, the study evaluated positioning accuracy of the independent axes of the Cartesian stages to quantify the error of the transmission system assembly and motor control performance. To fully validate its position accuracy, the carriage was first driven forward from its home position along the positive axis direction to the maximum limit position in 5 mm increments. Subsequently, the carriage was moved along the negative axis direction back to the home position in -5 mm increments. At each increment, the actual carriage position relative to the robot frame was recorded using a standard Vernier caliper (e.g., 500-196-30, Mitutoyo, Japan) with a resolution of 0.025 mm. Fig. 8 shows the x- and j!- stage carriages actuating to their corresponding limits, providing a total of 36 data points. As shown in FIG. 8, the mean absolute position error was 0.19 ± 0.13 mm for the x-stage and 0.17 ± 0.15 mm for the j’-stage.

[0159] As shown in FIG. 8, the position error behaved differently between different axes and directions. While the mean error was calculated as the absolute position error, FIG. 8 depicts the signed error to highlight the differing axis behavior. This difference was caused by differing carriage translational velocities, likely attributed to the manufacturing tolerances in the additive manufactured system, which impacted the bang-bang control strategy’s performance. For example, during the experiment, the x-stage of the upper Cartesian platform had a relatively uniform velocity in opposing directions. Conversely, the j!- stage of the upper Cartesian stage required 60s to transition from 0 to 30 mm, and 35s to return from 30 mm back to 0 mm. Displacements in the negative j’-di recti on for the corresponding stage had higher translational speeds, causing the system to be prone to overshoot, resulting in larger position errors. This is supported by the data in FIG. 8, where negative displacements in the -axis direction indicated a larger mean absolute error value (0.32 ± 0.08 mm) compared to negative displacements (0.05 ± 0.04 mm). However, even when considering the worst case scenario (two carriages with a 0.5 mm position deviation toward opposite directions along the diagonal direction), the needle tip position error on a targeting plane with a depth of 100 mm would only be 3.8 mm, which was relatively small compared to the clinically approved ablation HCC tumor size of 2-3 cm, and the typical ablation volume of 4 cm

[0041] ,

[0160] Free-space robot targeting accuracy validation. FIG. 9A shows a free-space bench-top experimental validation of the fabricated robot’s guiding accuracy for needle placement. As shown in FIG. 9A, the fabricated robot was secured on an aluminum extrusion frame for targeting performance characterization. The EM field generator was mounted underthe robot to measure the needle tip position with an electromagnetic (EM) tracking probe. Three fiducials were attached to the front supporting plate of the fabricated robot, which was utilized for registration during MRI-guided validations.

[0161] FIG. 9B shows the sampling points within the robot workspace for the firee- space accuracy test. For this experiment, the study selected 234 targets at an insertion depth of 80 mm to ensure a well-distributed coverage of carriage positions. The target poses consisted of 26 points that were chosen in the upper carriage and each was grouped with 9 points in the lower carriage in a 3-by-3 grid layout, as depicted in FIG. 9B. The relation between lower carriage grid layout dimension and upper carriage position was indicated by different colors. The grid layouts were designed to examine the robot accuracy performance at different needle incline angles and positions.

[0162] During the experiment, the study performed the measurement using an EM tracking system (Aurora, NDI Medical Inc.), which had a measurement error of 0.5mm. To obtain the needle insertion vector, the study inserted the EM tracking probe into the needle guide twice, once from the spherical bearing on the upper carriage toward the lower carriage, and a second time from the lower carriage to the top one. This process yielded two measured probe tip positions, which were subsequently transformed into the robot frame based on the rigid-point registration. These points were used to produce the position and orientation of the needle insertion vector. This vector was then extended to project a point onto the target plane that was at a depth of 80 mm, indicating the needle tip position if inserted, as shown in FIG. 9A.

[0163] The study defined the position error of the needle tip as the Euclidean distance between the target location and the intersection point of the needle insertion vector and the target plane. The average position error across all targets was 2.6 ± 1.3 mm. The study defined the orientation error as the angular difference between the desired and measured needle insertion vector, calculated using their dot product. The average measured value was 3.9° ± 1.2°. The study divided the 234 data points into 7 groups by their incline angle in order to provide a more detailed quantitative assessment of the robot’s targeting accuracy. FIG. 10 shows the relation between position error and incline angle of the 234 data points. As shown in the FIG. 10, the average position error increased with the incline angle due to the longer travel distance between the spherical bearings and the target plane, indicating the inherent variance in the accuracy performance of the robot.

[0164] Magnetic resonance imaging (MRI) phantom validation. The study performed MR-conditionality evaluations in a 3T Philips Ingenia Elition MRI scanner using 3D spoiledgradient-echo imaging. The study placed the robot 20 mm away from a water phantom. The study acquired the MRI image (field of view: 224 x 224 x 45 mm3, 1 x 1 x 5 mm3resolution, TR / TE = 13 / 2 ms) of the phantom under three scenarios: no robot in the scanner, robot off while in the scanner, and robot on while in the scanner.

[0165] FIG. 11 shows the magnetic resonance-conditionality results for the MRI phantom validation. As shown in FIG. 11, no obvious differences were observed in the images between the different scenarios, demonstrating the robot’s MR-conditionality with MR imaging. Additionally, the Signal-to-Noise Ratio (SNR)

[0042] of three images in FIG. 11 was 35.7 dB (without robot), 35.5 dB (with robot off) and 34.2 dB (with robot on), suggesting a negligible impact on image quality due to the presence of the robot.

[0166] FIG. 12 shows an MRI phantom insertion experiment with the fabricated robot mounted above the gelatin phantom. To simulate targeting in biological tissue inside the MR environment, a 10% by weight Knox™ (e.g., Kraft Foods Global, Inc., USA) gelatin phantom insertion experiment was conducted in the same MRI scanner, as shown in subpanel (A) of FIG. 12. While the experiment performed in a phantom study, subpanel (B) of FIG. 12 indicates that the robot can be used within the MRI bore with a large volunteer (113kg) and the robot met the size constraint imposed by the body coil.

[0167] However, the body coil depicted in subpanel (B) of FIG. 12 was not suitable for practical use as it potentially interfered with the needle entry path. This will be critical in facilitating the use of the robot in commercial MRI scanners in the long term. In the envisioned procedure, the adjustable straps can be used to mount the robot to the patient.

[0168] For the phantom experiment, the study performed a total of three insertions. FIG. 13 shows the three needle insertions during the phantom validation experiment. For each insertion, a random robot insertion pose was specified by the interventional radiologist, verified by the robotic engineer, and then the robot was commanded to move to that pose. The target position was then defined as the virtual position at the intersection of the targeting plane (105 mm from the robot base within the phantom) and needle insertion vector. Once the inverse kinematics was solved, the robot was commanded to move towards the desired pose, followed by the manual needle insertion. The real needle insertion vector and tip position were then measured using 3D spoiled gradient-echo imaging (field of view: 192 x 192 x 192 mm3, I x l x i mm3resolution, TR / TE = 13 / 4 ms) and converted to the robot frame using coordinate registration performed with three MR-visible fiducials mounted on robot supporting plate, as shown in FIG. 9A.

[0169] The study defined the position error of the needle tip as the Euclidean distance between the target location identified by the kinematic model and the measured location of the needle tip in the robot frame. The study defined the orientation error as the angular difference between the desired and measured needle insertion vectors in the robot frame, calculated using their dot product. The results indicated a tip position error of 2.9 ± 2.1 mm and an orientation angle error of 2.1° ± 1.4° between them.

[0170] Discussion

[0171] Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and stands as a preeminent contributor to cancer-associated mortalities across the world [1], [2], The incidence rate of HCC continues to rise due to the increasing number of nonalcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH) [3], [4], A variety of methods can be applied to treat HCC, including resection, transplantation, percutaneous ethanol injection (PEI), radiofrequency ablation (RFA), microwave ablation (MW A), transarterial chemoembolization (TACE), transarterial radioembolization (TARE), systemic chemotherapy, multikinase and immune checkpoint inhibitors, etc. [5], [6], Among these treatments, local ablations such as RFA and MWA are effective for treating early-stage HCC [5], [7], RFA and MWA offer effective curative outcomes in a minimally invasive manner, facilitating focal therapy treatment of the tumor while minimizing damage to surrounding healthy tissue. Compared to RFA, MWA has unique advantages including a wider active heating area and the capability for simultaneous activation of multiple antennae, enabling more rapid treatment of large or multifocal tumors [8],

[0172] Despite being a widely accepted approach, accurate and efficient delivery of thermal energy poses a significant technical challenge due to difficulties involved with accurate MWA needle placement [9], Intraprocedural guidance, such as ultrasound (US), computed tomography (CT), and magnetic resonance imaging (MRI), is typically employed to improve targeting accuracy and to optimize needle position relative to the tumor

[0010] , Of these, MRI is advantageous in providing (i) accurate 3D guidance toward the lesion

[0011] , (ii) high-resolution soft tissue imaging, and (iii) intraoperative thermometry feedback. However, a major limitation is that most MRI scanners are closed bore and provide limited access for needle insertion procedures

[0012] ,

[0013] , Current magnetic resonance imaging guided (MR- guided) liver interventions at Mayo Clinic typically require ~ 30-45 min to reach a single target. This difficulty has motivated the development of MR-guided robotic system that can efficiently and accurately place the needle inside the scanner.

[0173] Many robots have been developed to assist MR-guided needle insertion in medical procedures, including prostate ablations [14,

[0015] , neurosurgery [16-18], breast biopsy

[0019] , shoulder arthrography

[0020] ,

[0021] , and many more

[0022] , Robotic systems utilized in the context of abdominal interventions are typically classified into two primary categories:(1) those that are attached directly to the patient’s body, denoted as body-mounted robots, and (ii) those that are fixed to either the MRI gantry, surgical table, or the surrounding floor, denoted as table-mounted robots

[0023] , An early design of a table-mounted 3 -degree of freedom (DoF) robot was developed to guide an ablation needle holder via the remote center- of-motion (RCM) mechanism

[0024] , However, to fully control the position and orientation of the straight needle, a total of 5-DoF is needed (4-DoF for needle guidance and 1-DoF for insertion that can be manually or robotically controlled). Christoforou et al.

[0025] proposed a table-mounted robotic mechanism with 5-DoF that is manually actuated. A fully automated MR-conditional table-mounted robotic prototype endowed with 4-DoF was created by Franco et al.

[0026] , However, table-mounted robotic systems are subject to errors caused by tissue movement induced by physiological functions, such as breathing, or potential unexpected patient movement.

[0174] In addition to the table-mounted designs, many body-mounted mechanisms have also been developed. Body-mounted robotic systems potentially reduce the needle placement error caused by the reasons listed above by allowing the robot passive movement with the patient’s body

[0023] , [27-29], A body-mounted double-ring mechanism was developed by Hata et al.

[0030] for 2-DoF needle guidance. Bricault et al.

[0028] developed a body-mounted “light puncture robot” (LPR) that can actively manipulate 5-DoF of a needle within the MRI environment. Nevertheless, the support frame of LPR exhibits a relatively substantial volume, which could potentially conflict with the placement of body coils. A more compact 4-DoF body-mounted robot was developed using piezoelectric motors to control the position of two stacked Cartesian stages

[0031] , However, the use of piezoelectric motors often precludes real-time MR image acquisition during robot motion due to the potential RF interference

[0032] ,

[0175] The primary challenges in interventional MR-guided abdominal robot development include the following: (1) ensuring MR-conditionality and MR imaging quality;(2) size constraints imposed by the closed MRI bore and body imaging coils; and (3) accurate control of the 4-DoF required for effective needle guidance.

[0176] Microwave ablation (MW A), is an increasingly effective approach for treating liver cancer by delivering thermal energy to coagulate malignant tissue. The advantages ofMWA include 1) minimal invasiveness with a high safety profile, 2) precise focal tumor control, 3) favorable long-term survival outcomes, and 4) the ability to be combined with other treatment modalities. In the United States, approximately 43% of liver cancer patients are diagnosed at an early stage, with tumors measuring less than 3 cm and three or fewer in number. For these patients, percutaneous MWA enables in situ ablation of these small tumors, achieving complete cure in over 85% of cases, and is therefore considered a first-line curative treatment option.

[0177] Given its safety, minimal invasiveness, and effectiveness, MWA should be considered the gold standard for treating early-stage HCC. However, MWA is not without its challenges. Both MWA and other needle-based interventions require precise and safe needle trajectories toward dynamically moving targets within the liver. This level of precision is only achievable through a combination of accurate needle motion control and high-resolution image guidance. In the current practice, the clinicians typically increase the ablation power to generate a larger ablation zone in the hope to compensate for the inaccurate needle placement, but this will inevitably lead to unintended collateral thermal injury, particularly when are located near critical structures such as the colon, diaphragm, gallbladder, or main bile duct. Clinically, a targeting accuracy of 3-5 mm at an insertion depth of 10 cm is the minimal standard for effective MWA. However, achieving this level of precision is challenging due to several factors: poor imaging guidance from conventional ultrasound, CT, or stereotactic guidance; the hand-eye coordination required for manual needle placement; liver movement induced by cardiac movement and respiration, the later can be partially compensated via various respiration motion compensation techniques. Currently, an average of 4-5 insertion attempts are typically required to reach a single target, adding 45 minutes (upwards of 2 hours for complicated targets) to procedure times in our current practice. This increases the risk of tumor seeding, and negatively impacts the safety, efficiency, and costeffectiveness of the procedure. Furthermore, manual needle insertion is heavily dependent on the clinician’s experience, leading to variability in surgical outcomes.

[0178] Given the high prevalence of liver cancer, the liver motion dynamic property, and the accuracy required for quick and effective treatments, robot-assisted needle insertions have gained considerable attention in the liver intervention community. While robot-assisted needle placement addresses the challenge of accurate needle positioning, a critical remaining hurdle is the ability to monitor and control the ablation zone in real time. Ensuring that the ablation covers the entire target while avoiding damage to nearby critical structures is of significant clinical relevance such as safety and efficacy. Many empirical ablation modelsoverlook important biophysical factors, such as inhomogeneous thermal properties, heat dissipation near vascular, and heat-induced tissue shrinkage. Moreover, most ablation models are developed and validated using ex-vivo tissue samples, which may not be at body temperature, leading to significant discrepancies in reproducibility and accuracy during actual procedures. MRI is the only imaging modality capable of monitoring ablation temperature and accessing treatment outcomes intraoperatively. In addition, MRI is already the gold standard for liver cancer diagnosis. Thus, MRI-guided robotic MWA has the potential to provide one-stop-shop by offer several distinct advantages: 1) exceptional soft-tissue imaging of target, 2) 3D visualization at any imaging plane for optimal treatment planning, 3) accurate and safe needle insertion with efficient workflow, 4) real-time MRI thermometry feedback for intraoperative monitoring of ablation topology, and 5) high-resolution post-ablation imaging for treatment confirmation. A primary objective of this study was to create an MRI- guided robotic platform that improves MWA by enabling precise needle insertion with MRI- enabled feedback on target identification, needle tracking, and ablation assessment.

[0179] Conclusion

[0180] The construction and arrangement of the systems and methods as shown in the various implementations are illustrative only. Although only a few implementations have been described in detail in this disclosure, many modifications are possible (e.g., variations in sizes, dimensions, structures, shapes, and proportions of the various elements, values of parameters, mounting arrangements, use of materials, colors, orientations, etc.). For example, the position of elements may be reversed or otherwise varied, and the nature or number of discrete elements or positions may be altered or varied. Accordingly, all such modifications are intended to be included within the scope of the present disclosure. The order or sequence of any process or method steps may be varied or re-sequenced according to alternative implementations. Other substitutions, modifications, changes, and omissions may be made in the design, operating conditions, and arrangement of the implementations without departing from the scope of the present disclosure.

[0181] The present disclosure contemplates methods, systems, and program products on any machine-readable media for accomplishing various operations. The implementation of the present disclosure may be implemented using existing computer processors, or by a special purpose computer processor for an appropriate system, incorporated for this or another purpose, or by a hardwired system. Implementations within the scope of the present disclosure include program products including machine-readable media for carrying or having machine-executable instructions or data structures stored thereon. Such machine-readable media can be any available media that can be accessed by a general purpose or special purpose computer or other machine with a processor. By way of example, such machine-readable media can comprise RAM, ROM, EPROM, EEPROM, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to carry or store desired program code in the form of machineexecutable instructions or data structures, and which can be accessed by a general purpose or special purpose computer or other machine with a processor.

[0182] When information is transferred or provided over a network or another communications connection (either hardwired, wireless, or a combination of hardwired or wireless) to a machine, the machine properly views the connection as a machine-readable medium. Thus, any such connection is properly termed a machine-readable medium. Combinations of the above are also included within the scope of machine-readable media. Machine-executable instructions include, for example, instructions and data which cause a general-purpose computer, special purpose computer, or special purpose processing machines to perform a certain function or group of functions.

[0183] Although the figures show a specific order of method steps, the order of the steps may differ from what is depicted. Also, two or more steps may be performed concurrently or with partial concurrence. Such variation will depend on the software and hardware systems chosen and on the designer choice. All such variations are within the scope of the disclosure. Likewise, software implementations could be accomplished with standard programming techniques with rule-based logic and other logic to accomplish the various connection steps, processing steps, comparison steps, and decision steps.

[0184] Each and every feature described herein, and each and every combination of two or more of such features, is included within the scope of the present invention, provided that the features included in such a combination are not mutually inconsistent.

[0185] Although example embodiments of the disclosed technology are explained in detail herein, it is to be understood that other embodiments are contemplated. Accordingly, it is not intended that the disclosed technology be limited in its scope to the details of construction and arrangement of components set forth in the following description or illustrated in the drawings. The disclosed technology is capable of other embodiments and of being practiced or carried out in various ways.

[0186] It must also be noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or“approximately” one particular value and / or to “about” or “approximately” another particular value. When such a range is expressed, other exemplary embodiments include from the one particular value and / or to the other particular value.

[0187] By “comprising” or “containing” or “including” is meant that at least the named compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if the other such compounds, material, particles, method steps have the same function as what is named.

[0188] Unless otherwise expressly stated, it is in no way intended that any method set forth herein be construed as requiring that its steps be performed in a specific order.Accordingly, where a method claim does not actually recite an order to be followed by its steps or it is not otherwise specifically stated in the claims or descriptions that the steps are to be limited to a specific order, it is no way intended that an order be inferred, in any respect. This holds for any possible non-express basis for interpretation, including: matters of logic with respect to arrangement of steps or operational flow; plain meaning derived from grammatical organization or punctuation; the number or type of embodiments described in the specification.

[0189] While the methods and systems have been described in connection with certain embodiments and specific examples, it is not intended that the scope be limited to the particular embodiments set forth, as the embodiments herein are intended in all respects to be illustrative rather than restrictive.

[0190] The following patents, applications, and publications, as listed below and throughout this document, are hereby incorporated by reference in their entirety herein.[1] Balogh, J., D. Victor III., E. H. Asham, S. G. Burroughs, M. Bok-tour, A. Saharia, X. Li, R. M. Ghobrial, and H. P. Monsour Jr. Hepatocellular carcinoma: a review. J. Hepatocell Carcinoma. 3:41-53, 2016.[2] Siegel, R. L., K. D. Miller, H. E. Fuchs, and A. Jemal. Cancer statistics, 2022. CA. 72(l):7-33, 2022. https: / / doi. org / 10. 3322 / caac. 21708.[3] Ghouri, Y. A., I. Mian, and J. H. Rowe. Review of hepatocellular carcinoma: Epidemiology, etiology, and carcinogenesis. J. Car-cinog. 16: 1, 2017.[4] McGlynn, K. A., J. L. Petrick, and H. B. El-Serag. Epidemiology of hepatocellular carcinoma. Hepatology. 73:4-13, 2021.[5] Cabrera, R., and D. Nelson. The management of hepatocellular carcinoma. Aliment. Pharmacol. Therap. 31(4): 461-476, 2010.[6] Yang, J. D., and J. K. Heimbach. New advances in the diagnosis and management of hepatocellular carcinoma. BMJ. 2020. https: / / doi. org / 10. 1136 / bmj. m3544.[7] Chen, Z., H. Xie, M. Hu, T. Huang, Y. Hu, N. Sang, and Y. Zhao. Recent progress in treatment of hepatocellular carcinoma. Am. J. Cancer Res. 10(9):2993, 2020.[8] Facciorusso, A., G. Serviddio, and N. Muscatiello. Local ablative treatments for hepatocellular carcinoma: An updated review. World J. Gastrointest. Pharmacol. Ther. 7(4):477, 2016.[9] Hoffmann, R., H. Rempp, D.-E. KeBler, J. WeiB, P. L. Pereira, K. Nikolaou, and S. Clasen. MR-guided microwave ablation in hepatic tumors: Initial results in clinical routine. Eur. Radiol. 27: 1467-1476, 2017.

[0010] Kamarinos, N. V., E. Kaye, and C. Sofocleous. Image-guided thermal ablation for colorectal liver metastases. Tech. Vase. Interv. Radiol.23 (2): 100672, 2020.

[0011] Gedroyc, W. M. W. Magnetic resonance guidance of thermal ablation. Top. Magn. Reson. Imaging. 16(5):339- 353, 2005.

[0012] Hata, N., P. Moreira, and G. Fischer. Robotics in MRI-guided interventions. Top. Magn. Reson. Imaging. 27(1): 19-23, 2018.

[0013] Monfaredi, R., K. Cleary, and K. Sharma. MRI robots for needle-based interventions: systems and technology. Ann. Biomed. Eng. 46: 1479-1497, 2018.

[0014] Chen, Y., A. Squires, R. Seifabadi, S. Xu, H. K. Agarwal, M. Ber-nardo, P. A. Pinto, P. Choyke, B. Wood, and Z. T. H. Tse. Robotic system for MRI-guided focal laser ablation in the prostate. IEEE / ASME Trans. Mechatron. 22(1): 107-114, 2016.

[0015] Chen, Y., S. Xu, A. Squires, R. Seifabadi, I. B. Turkbey, P. A. Pinto, P. Choyke, B. Wood, and Z. T. H. Tse. MRI-guided robotically assisted focal laser ablation of the prostate using canine cadavers. IEEE Trans. Biomed. Eng. 65(7): 1434-1442, 2017.

[0016] Li, G., H. Su, G. A. Cole, W. Shang, K. Harrington, A. Camilo, J. G. Pilitsis, and G. S. Fischer. Robotic system for MRI-guided stereotactic neurosurgery. IEEE Trans. Biomed. Eng. 62(4): 1077-1088, 2014.

[0017] Gunderman, A.L., S. Sengupta, E. Siampli, D. Sigounas, C. Kellner, C. Oluigbo, K. Sharma, I. Godage, K. Cleary, and Y. Chen. A surgical platform for intracerebral hemorrhage robotic evacuation (aspihre): A non -metallic MR-guided concentric tube robot, https: / / arxiv. org / abs / 2206. 09848, 2022.

[0018] Chen, Y., I. S. Godage, S. Sengupta, C. L. Liu, K. D. Weaver, and E. J. Barth. MR-conditional steerable needle robot for intracerebral hemorrhage removal. Int. J. Comput. Assist. Radiol. Surg. 14: 105-115, 2019.

[0019] Groenhuis, V., J. Veltman, F. J. Siepel, and S. Stramigioli. Storm-ram 3: A magnetic resonance imaging-compatible robotic system for breast biopsy. IEEE Robot. Autom. Mag. 24(2):34-41, 2017.

[0020] Monfaredi, R., R. Seifabadi, I. lordachita, R. Sze, N. M. Safdar, K. Sharma, S. Fricke, A. Krieger, and K. Cleary. A prototype body-mounted MRI-compatible robot for needle guidance in shoulder arthrography. In: 5th IEEE RAS / EMBS International Conference on Biomedical Robotics and Biomechatronics, pp. 40-45, IEEE, 2014.

[0021] Monfaredi, R., I. lordachita, E. Wilson, R. Sze, K. Sharma, A. Krieger, S. Fricke, and K. Cleary. Development of a shoulder-mounted robot for MRI-guided needle placement: phantom study. Int. J. Comput. Assist. Radiol. Surg. 13: 1829-1841, 2018.

[0022] Chen, Y., I. Godage, H. Su, A. Song, and H. Yu. Stereotactic systems for MRI guided neurosurgeries: a state-of-the-art review. Ann. Biomed. Eng. 47:335-353, 2019.

[0023] Arnolli, M. M., N. C. Hanumara, M. Franken, D. M. Brouwer, and I. A. Breeders. An overview of systems for CT-and MRI-guided percutaneous needle placement in the thorax and abdomen. Int. J. Med. Robot. Comput. Assist. Surg. 11(4):458-475, 2015.

[0024] Hata, N., R. Hashimoto, J. Tokuda, and S. Morikawa. Needle guiding robot for MR guided microwave thermotherapy of liver tumor using motorized remote-center of- motion constraint. In: Proceedings of the 2005 IEEE International Conference on Robotics and Automation, pp. 1652-1656. IEEE, 2005.

[0025] Christoforou, E. G., I. Seimenis, E. Andreou, E. Eracleous, and N.V.Tsekos. A novel, general-purpose, MR-compatible, manually actuated robotic manipulation system for minimally invasive interventions under direct MRI guidance. Int. J. Med. Robot. Comput. Assist. Surg. 10(l):22-34, 2014.

[0026] Franco, E., D. Brujic, M. Rea, W. M. Gedroyc, and M. Ristic. Needle-guiding robot for laser ablation of liver tumors under MRI guidance. IEEE / ASME Trans. Mechatron. 21(2):931-944, 2015.

[0027] Musa, M. J., K. Sharma, K. Cleary, and Y. Chen. Respiratory compensated robot for liver cancer treatment: Design, fabrication, and benchtop characterization. IEEE / ASME Trans. Mechatron. 27(l):268-279, 2021.

[0028] Bricault, I., N. Zemiti, E. Jouniaux, C. Fouard, E. Taillant, F. Dorandeu, and P. Cinquin. Light puncture robot for CT and MRI interventions. IEEE Eng. Med. Biol. Mag. 27(3):42-50, 2008.

[0029] Gunderman, A. L., M. Musa, B. O. Gunderman, F. Banovac, K. Cleary, X. Yang, and Y. Chen. Autonomous respiratory motion compensated robot for CT-guided abdominal radiofrequency ablations. IEEE Trans. Med. Robot. Bionics. 5:206-217, 2023.

[0030] Hata, N., S.-E. Song, O. Olubiyi, Y. Arimitsu, K. Fujimoto, T. Kato, K. Tuncali, S. Tani, and J. Tokuda. Body-mounted robotic instrument guide for image-guided cryotherapy of renal cancer. Med. Phys. 43(2):843-853, 2016.

[0031] Li, G., N. A. Patel, J. Hagemeister, J. Yan, D. Wu, K. Sharma, K. Cleary, and I. lordachita. Body-mounted robotic assistant for MRI-guided low back pain injection. Int. J. Comput. Assist. Radiol. Surg. 15(2):321— 331, 2020.

[0032] Xiao, Q., R. Monfaredi, M. Musa, K. Cleary, and Y. Chen. Mr-conditional actuations: A review. Ann. Biomed. Eng. 48:2707-2733, 2020.

[0033] Chen, Y., I. S. Godage, Z. T. H. Tse, R. J. Webster, and E. J. Barth. Characterization and control of a pneumatic motor for MR-conditional robotic applications. IEEE / ASME Trans. Mechatron. 22(6):2780-2789, 2017.

[0034] Gunderman, A. L., M. Azizkhani, S. Sengupta, K. Cleary, and Y. Chen. Open source MR-safe pneumatic radial inflow motor and encoder (prime): Design and manufacturing guidelines. In: 2023 International Symposium on Medical Robotics (ISMR), pp. 1-7, IEEE, 2023.

[0035] Dezsofi, A., U. Baumann, A. Dhawan, O. Durmaz, B. Fischler, N. Hadzic, L. Hierro, F. Lacaille, V. A. McLin, V. Nobili, et al. Liver biopsy in children: Position paper of the espghan hepatology committee. J. Pediatr. Gastroenterol. Nutr. 60(3):408-420, 2015.

[0036] Gjerstad, A. C., R. Skrunes, C. Tondel, A. Asberg, S. Leh, C. Klingenberg, H. Dollner, C. Hammarstrom, and A. K. Bjerre. Kid-ney biopsy diagnosis in childhood in the norwegian kidney biopsy registry and the long-term risk of kidney replacement therapy: a 25-year follow-up. Pediatr. Nephrol. 38(4): 1249-1256, 2023.

[0037] Gunderman, A., S. Sengupta, Z. Huang, D. Sigounas, C. Oluigbo, I. Godage, K. Cleary, and Y. Chen. Towards MR-guided robotic intracerebral hemorrhage evacuation: Aiming device design and ex vivo sheep head trial. IEEE Trans. Med. Robot. Bionics. 2024.

[0038] Gunderman, A. L., M. Azizkhani, S. Sengupta, K. Cleary, and Y. Chen. Modeling and control of an open-source MR-safe pneu-matic radial inflow motor and encoder. IEEE Trans. Mechatron. 2023. https: / / doi. org / 10. 1109 / TMECH. 2023. 33292 96.

[0039] Su, S., W. Wang, D. Nadebaum, A. Nicoll, S. Sood, A. Gore-lik, J. Lai, and R. Gibson. Skin-liver distance and interquartile range-median ratio as determinants ofinteroperator concordance in acoustic radiation force impulse imaging. J. Med. Ultrasound. 27(4): 177, 2019.

[0040] Urata, K., Y. Hashikura, T. Ikegami, M. Terada, and S. Kawasaki. Standard liver volume in adults. Transpl. Proc. 32:2093-2094, 2000.

[0041] Rhim, H., and H. K. Lim. Radiofrequency ablation of hepatocellular carcinoma: Pros and cons. Gut Liver. 4(Suppl 1): 113, 2010.

[0042] Kaufman, L., D. M. Kramer, L. E. Crooks, and D. A. Ortend-ahl. Measuring signal to-noise ratios in MR imaging. Radiology. 173(l):265-267, 1989.

[0043] Gunderman, A. L., S. Sengupta, E. Siampli, D. Sigounas, C. Kell-ner, C. Oluigbo, K. Sharma, I. Godage, K. Cleary, and Y. Chen. Non-metallic MR-guided concentric tube robot for intracerebral hemorrhage evacuation. IEEE Trans. Biomed. Eng. 70:2895-2904, 2023.

[0044] Huang, Z., H. Alkhars, A. Gunderman, D. Sigounas, K. Cleary, and Y. Chen. Optimal concentric tube robot design for safe intracerebral hemorrhage removal. J. Meeh. Robot. 16:8, 2023. https: / / doi. org / 10. 1115 / 1. 40639 79.

Claims

What is claimed:

1. A needle insertion and tracking device comprising: a first carriage comprising an upper guide movable along a first plane in each of a first direction and a second direction; a second carriage comprising a lower guide movable along a second plane in each of the first direction and the second direction, wherein the second plane is substantially parallel to and spaced apart from the first plane; at least one actuator coupled to each of the first carriage and the second carriage, the at least one actuator configured to controllably move the upper guide to a desired first location in the first plane and to controllably move the lower guide to a desired second location in the second plane, wherein the needle insertion and tracking device is compatible with a magnetic resonance imaging machine and comprises non-metallic materials.

2. The needle insertion and tracking device of claim 1, further comprising a needle guide coupled to the upper guide of the first carriage and extending to the lower guide of the second carriage.

3. The needle insertion and tracking device of claim 2, wherein the needle guide is configured for accepting a needle or a microwave ablation tool and guiding insertion of the needle or the microwave ablation tool into a target location.

4. The needle insertion and tracking device of any of claims 2-3, wherein the desired first location of the upper guide and the desired second location of the lower guide facilitate orientation the needle guide along a first vector, wherein the first vector is selected based on a target location spaced apart from the needle insertion and tracking device.

5. The needle insertion and tracking device of any of claims 1-4, wherein the first carriage including the upper guide is slidable along one or more guide rods disposed in the first plane via one or more spherical bearings.

6. The needle insertion and tracking device of any of claims 1-5, wherein the second carriage including the lower guide is slidable along one or more guide rods disposed in the second plane via one or more spherical bearings.

7. The needle insertion and tracking device of any of claims 1-6, wherein the at least one actuator comprises a first motor configured to drive a first lead screw that is coupled to the first carriage to move the first carriage along the first plane in one of the first direction or the second direction.

8. The needle insertion and tracking device of any of claims 1-7, wherein the at least one actuator comprises a second motor configured to drive a second lead screw that is coupled to the first carriage to move the first carriage along the first plane in the other one of the first direction or the second direction.

9. The needle insertion and tracking device of any of claims 1-8, wherein the at least one actuator comprises at least one piezoelectric actuator configured to move the first carriage and / or the second carriage in one or more of the first direction and the second direction.

10. The needle insertion and tracking device of claim 9, further comprising a third lead screw coupled to the second lead screw via a timing belt to ensure consistent motion across opposing sides of the needle insertion and tracking device.

11. The needle insertion and tracking device of any of claims 1-10, wherein the at least one actuator is coupled to a gearbox configured for gear reduction.

12. The needle insertion and tracking device of any of claims 1-11, further comprising a plurality of optic encoders coupled to at least the first and second carriages, the plurality of optic encoders configured to track the motion of the first and second carriages in the first and second planes, respectively.

13. The needle insertion and tracking device of any of claims 1-12, further comprising a housing defining a cavity within which the first and second carriages are disposed, the cavity including at least one insertion opening aligned with the lower guide and at least one insertion opening aligned with the upper guide, the at least one insertion opening facilitating the insertion of the needle or the microwave ablation tool into, through, and out of the cavity.

14. The needle insertion and tracking device of any of claims 1-13, further comprising at least one port configured to provide an input or an output for a pneumatic conduit, a fiber optic cable, and / or an other magnetic resonance compatible signal line.

15. The needle insertion and tracking device of any of claims 1-14, further comprising an attachment device configured to affix the needle insertion and tracking device to a patient.

16. The needle insertion and tracking device of any of claims 1-15, wherein the first direction is an x-direction and the second direction is a y-direction.

17. The needle insertion and tracking device of any of claims 1-16, wherein the first direction is a first circular direction, and the second direction is a second circular.

18. A system comprising: a needle insertion and tracking device comprising: a first carriage comprising an upper guide movable along a first plane in each of a first direction and a second direction; and a second carriage comprising a lower guide movable along a second plane in each of the first direction and the second direction, wherein the second plane is substantially parallel to and spaced apart from the first plane; and a needle guide coupled to the upper guide of the first carriage and extending to the lower guide of the second carriage, wherein the needle insertion and tracking device is compatible with a magnetic resonance imaging machine and comprises non-metallic materials; an actuation system comprising: a plurality of actuators including a first actuator and a second actuator, wherein the first actuator is coupled to the first carriage and configured to controllably move the upper guide to a desired first location in the first plane, and the second actuator is coupled to the second carriage and configured to controllably move the lower guide to a desired second location in the second plane; a pump in fluid communication with the first and second actuators; and a control system in communication with each of the needle insertion and tracking device and the actuation system, the control system configured to collect position data aboutthe first and second carriages, the control system further configured to move the first and second carriages to the desired first and second locations via the actuation system.

19. The system of claim 18, wherein the actuation system is a piezoelectric actuation system, and the first and second actuators are at least one first and second piezoelectric actuator.

20. The system of claim 19, wherein the actuation system is a pneumatic actuation system, and the first and second actuators are a first and second pneumatic motors, the pneumatic actuation system further comprising a manifold comprising at least one valve, the manifold coupled between the pump and the first and second pneumatic motors, wherein one or more pneumatic conduits are coupled between the manifold and the plurality of pneumatic motors.

21. The system of claim 20, wherein that at least one valve of the manifold is controllable to open or close based on instructions from the control system, wherein, when a first valve of the at least one valve coupled to the first pneumatic motor is open, the first pneumatic motor causes the first carriage to move in one of the first direction or the second direction.

22. The system of any of claims 18-21, wherein the first carriage including the upper guide is slidable along one or more guide rods disposed in the first plane via one or more spherical bearings, and wherein the second carriage including the lower guide is slidable along one or more guide rods disposed in the second plane via one or more spherical bearings.

23. The system of any of claims 18-22, wherein the desired first location of the upper guide and the desired second location of the lower guide facilitate orientation of the needle guide along a desired vector, wherein the desired vector is selected based on a target location spaced apart from the needle insertion and tracking device.

24. The system of any of claims 18-23, wherein the needle insertion and tracking device further comprises a plurality of optic encoders coupled to at least the first and second carriages, the plurality of optic encoders configured to track the motion of the first andsecond carriages in the first and second planes, respectively, and relay positional data about the first and second carriages to the control system.

25. The system of any of claims 23-24, wherein the control system is configured to interpret positional data about the first and second carriages, calculate a directional vector of the needle guide, and activate the actuation system to move one or more of the first and second carriages to adjust the directional vector to match the desired vector.

26. A method comprising: providing a needle insertion and tracking device comprising: a first carriage comprising an upper guide movable along a first plane in each of a first direction and a second direction; a second carriage comprising a lower guide movable along a second plane in each of the first direction and the second direction, wherein the second plane is substantially parallel to and spaced apart from the first plane; a needle guide coupled to the upper guide of the first carriage and extending to the lower guide of the second carriage; at least one actuator coupled to each of the first carriage and the second carriage, the at least one actuator configured to controllably move the upper guide to a desired first location in the first plane and to controllably move the lower guide to a desired second location in the second plane, wherein the needle insertion and tracking device is compatible with a magnetic resonance imaging (MRI) machine and comprises non-metallic materials; securing the needle insertion and tracking device to a patient adjacent to a target region; selecting a target point of the target region and an entry point on a patient’s skin; moving the first carriage and the second carriage such that a projected vector of the needle guide aligns with one or both of the target point and the entry point.

27. The method of claim 26, further comprising: inserting a needle into the needle guide and towards through the entry point; tracking the location of the needle via the MRI machine.

28. The method of claim 27, further comprising adjusting a location and / or a direction of the needle based on information from the MRI machine.

29. The method of claim 28, wherein the adjusting is automatically performed via a control system.

30. The method of any of claims 26-29, further comprising: performing a microwave ablation procedure at the target point with the needle.

31. The method of any of claims 26-30, wherein moving the first carriage and the second carriage is performed via a pneumatic actuation system comprising the at least one actuator, wherein the at least one actuator comprises a first pneumatic motor and a second pneumatic motor.

32. The method of claim 31, wherein the pneumatic actuation system further comprises a manifold comprising at least one valve, the manifold coupled between a pump and the first and second pneumatic motors, wherein one or more pneumatic conduits are coupled between the manifold and the first and second pneumatic motors.

33. The method of claim 32, wherein the at least one valve of the manifold is controllable to open or close based on instructions from the control system.

34. The method of any of claims 26-33, wherein the needle insertion and tracking device further comprises a plurality of optic encoders coupled to at least the first and second carriages, the plurality of optic encoders configured to track the motion of the first and second carriages in the first and second planes, respectively, and relay positional data about the first and second carriages to the control system.

Images