Robotically manipulated tissue treatment system

Abstract

Provided herein are systems, devices, and methods for performing a medical procedure on a patient. A system can include a treatment device comprising a treatment assembly that is configured to perform a treatment procedure on target tissue of the patient; an ultrasound assembly including a set of one or more ultrasound transducers, the ultrasound assembly configured to produce image data; and a robotic manipulation assembly configured to robotically manipulate a set of one or more system components based on the image data.

Description

[0001] ROBOTICALLY MANIPULATED TISSUE TREATMENT SYSTEM

[0002] RELATED APPLICATIONS

[0003]

[0001] This application claims the benefit of United States Provisional Patent Application Serial Number 63 / 662,451 (Docket No. USD-012-PR1), titled “Robotically Manipulated Tissue Treatment System”, filed June 21, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[0004]

[0002] This application is related to United States Provisional Application Serial Number 62 / 728,616, (Docket No. USD-001-PR), titled “Medical Device with CMUT Array and Solid State Cooling, and Associated Methods and Systems - with Thermal Analysis”, filed September 7, 2018, the content of which is incorporated by reference in its entirety for all purposes.

[0005]

[0003] This application is related to International PCT Patent Application Serial Number PCT / US2018 / 050943, (Docket No. USD-001-PCT), titled “Medical Device with CMUT Array and Solid State Cooling, and Associated Methods and Systems” filed September 13, 2018, Publication Number WO 2019 / 055699, published March 21, 2019, the content of which is incorporated by reference in its entirety for all purposes.

[0006]

[0004] This application is related to United States Application Serial Number 16 / 130,896, (Docket no. USD-001 -US), titled “Medical Device with CMUT Array and Solid State Cooling, and Associated Methods and Systems”, filed September 13, 2018, United States Patent Number 11,154,730, issued October 26, 2021, the content of which is incorporated by reference in its entirety for all purposes.

[0007]

[0005] This application is related to United States Patent Application Serial Number 17 / 479,011 (Docket No. USD-001-US-CON1), titled “Medical Device with CMUT Array and Solid State Cooling, And Associated Methods and Systems”, filed September 20, 2021, United States Patent Number 11,998,766, issued June 4, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[0008]

[0006] This application is related to United States Patent Application Serial Number 18 / 640,305 (Docket No. USD-001-US-CON2), titled “Medical Device with CMUT Array and Solid State Cooling, And Associated Methods and Systems”, filed April 19, 2024, United States Publication Number US 2024-0285980 published August 24, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[0009]

[0007] This application is related to United States Provisional Patent Application Serial Number 63 / 126,078 (Docket No. USD-003-PR1), titled “Tissue Interface System”, filed December 16, 2020, the content of which is incorporated herein by reference in its entirety for all purposes.

[0010]

[0008] This application is related to United States Application Serial Number 18 / 039,978, (Docket no. USD-003-US), titled “Tissue Interface System”, filed June 2, 2023, United States Publication Number US 2023 / 0414299, published December 28, 2023, the content of which is incorporated by reference in its entirety for all purposes.

[0011]

[0009] This application is related to International PCT Patent Application Serial Number PCT / US2021 / 063743, (Docket No.USD-003 -PCT), titled “Tissue Interface System”, filed December 16, 2021, Publication Number WO 2022 / 133054, published June 23, 2022, the content of which is incorporated by reference in its entirety for all purposes.

[0012]

[0010] This application is related to United States Provisional Patent Application Serial Number 63 / 195,292 (Docket No. USD-004-PR1), titled “Tissue Treatment System”, filed June 1, 2021, the content of which is incorporated herein by reference in its entirety for all purposes.

[0013]

[0011] This application is related to International PCT Patent Application Serial Number PCT / US22 / 031746, (Docket No.USD-004-PCT), titled “Tissue Treatment System”, filed June 1, 2022, Publication Number WO 2022 / 256388, published December 8,

[0014] 2022, the content of which is incorporated by reference in its entirety for all purposes.

[0015]

[0012] This application is related to United States Application Serial Number 18 / 564,181, (Docket no. USD-004-US), titled “Tissue Treatment System”, filed November 27,

[0016] 2023, United States Publication Number 2024-0252845, published August 1, 2024, the content of which is incorporated by reference in its entirety for all purposes.

[0017]

[0013] This application is related to United States Provisional Patent Application Serial Number 63 / 286,161 (Docket No. USD-008-PR1), titled “Capacitive Micromachined Ultrasonic Transducer”, filed December 6, 2021, the content of which is incorporated herein by reference in its entirety for all purposes.

[0018]

[0014] This application is related to International PCT Patent Application Serial Number PCT / US22 / 051937, (Docket No. USD-008-PCT), titled “Capacitive Micromachined Ultrasonic Transducer” filed December 6, 2022, Publication Number WO 2023 / 107433, published June 15, 2023, the content of which is incorporated by reference in its entirety for all purposes.

[0019]

[0015] This application is related to United States Application Serial Number 18 / 714,768, (Docket no. USD-008-US), titled “Capacitive Micromachined Ultrasonic Transducer”, filed May 30, 2024, United States Publication Number , published , the content of which is incorporated by reference in its entirety for all purposes.

[0020]

[0016] This application is related to United States Provisional Patent Application Serial Number 63 / 450,490 (Docket No. USD-010-PR1), titled “Capacitive Micromachined Ultrasonic Transducer and Manufacturing Methods Thereof’, filed March 7, 2023, the content of which is incorporated herein by reference in its entirety for all purposes.

[0021]

[0017] This application is related to International PCT Patent Application Serial Number PCT / US24 / 018763, (Docket No. USD-010-PCT), titled “Capacitive Micromachined Ultrasonic Transducer and Manufacturing Methods Thereof’ filed March 7, 2024, Publication Number WO 2024 / 186948, published September 12, 2024, the content of which is incorporated by reference in its entirety for all purposes.

[0022]

[0018] This application is related to United States Provisional Patent Application Serial Number 63 / 556,111 (Docket No. USD-011-PR1), titled “Ultrasound System”, filed February 21, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[0023]

[0019] This application is related to United States Provisional Patent Application Serial Number 63 / 735,560 (Docket No. USD-011-PR2), titled “Ultrasound System”, filed December 18, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[0024]

[0020] This application is related to International PCT Patent Application Serial Number PCT / US25 / 016752, (Docket No. USD-011 -PCT), titled “Ultrasound System” filed February 21, 2025, Publication Number > , published , the content of which is incorporated by reference in its entirety for all purposes.

[0025] FIELD OF INVENTIVE CONCEPTS

[0026]

[0021] The present inventive concepts relate generally to systems, devices, and methods for performing a medical procedure on a patient, particularly systems that robotically manipulate one or more devices in the performance of the procedure.

[0027] BACKGROUND

[0028]

[0022] Numerous medical devices involve robotic control of devices used to perform a medical procedure on a patient. There is a need for improved systems, devices, and methods for transmitting energy to diagnose or treat diseases and disorders of patients.

[0029] SUMMARY

[0030]

[0023] According to an aspect the present inventive concepts, a system for performing a medical procedure on a patient comprises: a treatment device comprising a treatment assembly that is configured to perform a treatment procedure on target tissue of the patient; an ultrasound assembly comprising a set of one or more ultrasound transducers, the ultrasound assembly configured to produce image data; and a robotic manipulation assembly configured to robotically manipulate a set of one or more system components based on the image data. The set of one or more system components comprises at least: the treatment assembly of the treatment device; the ultrasound assembly; or both.

[0031]

[0024] In some embodiments, the system is configured to produce an anatomical model based on the image data. The anatomical model can comprise a 2D model, a 3D model, or both. The system can be configured to produce the anatomical model based on known properties of materials that can be in the acoustic pathway of the ultrasound assembly. The anatomical model can comprise actual and / or projected temperature information associated with a current and / or future ablation of target tissue.

[0032]

[0025] In some embodiments, the system is configured to: collect a first set of image data; perform a first tissue treatment procedure to treat a first volume of target tissue based on the first set of image data; collect a second set of image data; and perform a second tissue treatment procedure to treat a second volume of target tissue based on the second set of image data. The second set of image data includes identification of un-treated tissue that was intended to be treated in the first tissue treatment procedure.

[0033]

[0026] In some embodiments, the system comprises an energy delivery component configured to deliver energy to tissue to treat the tissue. The treatment assembly and / or another component of the treatment device can comprise the energy delivery component. The ultrasound assembly can comprise the energy delivery component. The system can further comprise a surgical tissue treatment tool that can comprise the energy delivery component. The system can be configured to change the current field of view of the energy delivery component via one or more of: (1) an electronic focus adjustment of the energy delivery component; (2) translation and / or rotation of the energy delivery component within a surrounding shaft; and / or (3) translation and / or rotation of a shaft that surrounds the energy delivery component. The (1) can have a narrower range of the collective field of view than (2), and (2) can have a narrower range of the collective field of view than (3). The (1) can provide finer control of the adjustment of the field of view than (2), and (2) can provide finer control of the adjustment of the field of view than (3). The system can be configured to change the field of view of the energy delivery component via two or more of: (1) an electronic focus adjustment of the energy delivery component; (2) translation and / or rotation of the energy delivery component within a surrounding shaft; and / or (3) translation and / or rotation of a shaft that surrounds the energy delivery component. The system can be configured to change the field of view of the energy delivery component via all of: (1) an electronic focus adjustment of the energy delivery component; (2) translation and / or rotation of the energy delivery component within a surrounding shaft; and (3) translation and / or rotation of a shaft that surrounds the energy delivery component.

[0034]

[0027] In some embodiments, the robotic manipulation comprises a motion comprising: advancement; retraction; rotation; expansion; contraction; bending and / or other articulation; and / or other manipulation of a system component that is performed automatically by the system.

[0035]

[0028] In some embodiments, the robotic manipulation comprises an automatic motion comprising: advancement; retraction; rotation; expansion; contraction; bending and / or other articulation; and / or other manipulation of a system component that is performed automatically by the system.

[0036]

[0029] In some embodiments, the robotic manipulation comprises an automatic cessation of motion of a system component that is performed automatically by the system.

[0030] In some embodiments, the robotic manipulation comprises an operator-controlled manual motion comprising: translation; rotation; expansion; contraction; bending and / or other articulation; twisting; and / or other manipulation of a system component.

[0037]

[0031] In some embodiments, the system further comprises an imaging device, and the robotic manipulation comprises robotic manipulation of the imaging device, and the imaging device is configured to produce additional image data, and the robotic manipulation of the imaging device is based on additional image data that is produced concurrent with the robotic manipulation. The imaging device can comprise the ultrasound assembly.

[0038]

[0032] In some embodiments, the image data comprises data related to blood flow of the patient. The image data can comprise blood flow data collected using doppler ultrasound.

[0039]

[0033] In some embodiments, the ultrasound assembly is configured to be translated, rotated, articulated, and / or otherwise manipulated during the production of the image data. The ultrasound assembly can be configured to be manipulated by the robotic manipulation assembly. The system can be configured to perform the manipulation of the ultrasound assembly automatically.

[0040]

[0034] In some embodiments, the medical procedure comprises a procedure selected from the group consisting of: a benign prostatic hyperplasia treatment procedure; an endometriosis treatment procedure; a fibroid treatment procedure, such as category 1 fibroid treatment procedure; a fallopian tube treatment procedure; a sleep apnea-reducing procedure; a tumor treatment procedure; a biopsy procedure; an agent delivery procedure; a transabdominal procedure; a transvaginal procedure; and combinations thereof.

[0041]

[0035] In some embodiments, the medical procedure comprises a treatment of benign prostatic hyperplasia.

[0042]

[0036] In some embodiments, the medical procedure comprises a treatment of endometriosis. The endometriosis treatment can comprise delivery of high intensity focused ultrasound (HIFU) energy by the ultrasound assembly at a depth of no more than 7mm, 6mm, and / or 5mm from a surface of tissue.

[0043]

[0037] In some embodiments, the medical procedure comprises ablation of a fibroid. The fibroid can comprise a category 1 fibroid. The system can be configured to ablate at least 50% of the fibroid. The ultrasound assembly can be configured to produce image data comprising data related to the fibroid and data related to ablated tissue of the fibroid. The ablation can comprise automatic delivery of HIFU energy by the system.

[0038] In some embodiments, the medical procedure comprises ablation of fallopian tubes.

[0044]

[0039] In some embodiments, the medical procedure comprises a biopsy procedure, and the treatment device comprises a biopsy needle. The biopsy procedure can comprise a biopsy of the prostate.

[0045]

[0040] In some embodiments, the medical procedure comprises an agent delivery procedure. The ultrasound assembly can be configured to deliver ultrasound energy to cells to modify absorption of the agent by the cells. The treatment device can comprise a delivery element configured to deliver the agent.

[0046]

[0041] In some embodiments, the target tissue comprises two or more volumes of target tissue. The two or more volumes of target tissue can comprise: two or more adjacent volumes of target tissue; two or more non-adjacent volumes of target tissue; or both. The two or more volumes of target tissue can comprise: two or more fibroids; two or more volumes of tissue of the tongue; two or more volumes of tissue of a tonsil; two or more volumes of tissue of the soft palate; and / or two or more tumors.

[0047]

[0042] In some embodiments, the target tissue comprises prostatic tissue. The non-target tissue can comprise tissue types selected from the group consisting of: seminal duct; verumontanum; sphincter; calcification-tissue; and combinations thereof.

[0048]

[0043] In some embodiments, the target tissue comprises fibroid tissue.

[0049]

[0044] In some embodiments, the target tissue comprises tissue of the tongue, the soft palate, a tonsil, or two or three of these.

[0050]

[0045] In some embodiments, the target tissue comprises tissue of a blood vessel. The blood vessel can comprise a blood vessel proximate other target tissue to be treated.

[0051]

[0046] In some embodiments, the non-target tissue comprises tissue of a blood vessel.

[0052]

[0047] In some embodiments, the target tissue comprises tumor tissue. The tumor tissue can comprise tumor tissue of an organ selected from the group consisting of: lung; liver; pancreas; brain; breast; bladder; prostate; ovary; and combinations thereof.

[0053]

[0048] In some embodiments, the treatment procedure comprises delivery of energy to ablate the target tissue. The energy can comprise HIFU energy and / or other ultrasound energy. The delivery of energy can comprise delivery of energy in an energy form selected from the group consisting of: sound energy, such as ultrasound energy; light energy, such as laser light energy; thermal energy, such as heat energy and / or cryogenic energy; electromagnetic energy, such as radiofrequency energy, microwave energy, and / or electroporation energy; chemical energy; mechanical energy; and combinations thereof.

[0049] In some embodiments, the treatment device comprises at least a portion of the ultrasound assembly. The treatment device can comprise a balloon, expandable cage, unfurlable element, and / or other positioning element that can be located proximate the at least a portion of the ultrasound assembly. The positioning element can be configured to expand and / or contract to controllably position the at least a portion of the ultrasound assembly at a determined distance from the target tissue. The expansion and / or contraction can be configured to be manually controlled by an operator of the system. The expansion and / or contraction can be configured to be automatically controlled by the system. The balloon can be configured to receive a fluid to create an acoustic pathway comprising a fluid pathway between the at least a portion of the ultrasound assembly and the target tissue.

[0054]

[0050] In some embodiments, the treatment device comprises one, two, or more devices selected from the group consisting of: elongate tool; catheter; probe; laparoscopic probe; surgical tool; minimally invasive surgical tool; hand-held tool; robotically-manipulatable tool; and combinations thereof.

[0055]

[0051] In some embodiments, the treatment device comprises an elongate tool. The elongate tool can comprise a distal portion and a more proximal portion, and a first axis of the distal portion can be angularly offset from a second axis of the more proximal portion, and the ultrasound assembly can comprise a first ultrasound array positioned in the distal portion. The first axis can be offset from the second axis by an angle of at least 45 degrees, or 90 degrees. The distal portion can be configured to be positioned along the wall of a uterus.

[0052] In some embodiments, the treatment device comprises a catheter.

[0056]

[0053] In some embodiments, the treatment device is configured to be inserted into the patient through a device selected from the group consisting of: introducer; vascular introducer; laparoscopic port; endoscope; retractor; cervical expansion device; and combinations thereof.

[0057]

[0054] In some embodiments, the treatment device is configured to be inserted through a natural orifice of the patient.

[0058]

[0055] In some embodiments, the treatment device is configured to be inserted through a surgical incision of the patient.

[0059]

[0056] In some embodiments, the treatment device comprises an elongate shaft.

[0057] In some embodiments, the set of one or more ultrasound transducers comprises one or more CMUTs, one or more piezo-based transducers, or both.

[0060]

[0058] In some embodiments, the ultrasound assembly is configured to perform the target tissue treatment procedure via the delivery of HIFU and / or other ablative ultrasound energy. The system can be configured to adjust the frequency of the ablative ultrasound energy delivery based on one or more of: distance to the target tissue; tissue type of the target tissue; and / or characteristics of tissue between the ultrasound transducers and the target tissue. The ultrasound assembly can be configured to adjust the focus of ultrasound energy delivery to ablate a first volume of target tissue and to ablate a second volume of target tissue. The system can be configured to dynamically adjust the focus of the ultrasound energy delivery to the first volume of target tissue, the second volume of target tissue, or both. The system can be configured to simultaneously ablate the first and second volumes of target tissue.

[0061]

[0059] In some embodiments, the system is configured to interleave between delivery of ultrasound energy for collecting the image data and delivery of ultrasound energy for treating the target tissue. The system can be configured to adjust the frequency of the ultrasound energy delivered to produce the image data. The system can be configured to adjust the frequency of the ultrasound energy delivered to produce the image data, and the adjustment can be based on one or more of: resolution and / or other image property of image data to be produced; distance to tissue to be imaged; tissue type of tissue to be imaged; and / or characteristics of tissue between the ultrasound transducers and the tissue to be imaged. The system can be configured to dynamically adjust imaging time, treatment time, or both. The system can be configured to dynamically adjust the focus of ultrasound energy for imaging, treatment, or both.

[0062]

[0060] In some embodiments, the ultrasound assembly comprises a gel block configured to be positioned between the one or more ultrasound transducers and tissue.

[0063]

[0061] In some embodiments, the ultrasound assembly comprises at least one ID ultrasound array. The ultrasound assembly can comprise multiple ID ultrasound arrays.

[0062] In some embodiments, the ultrasound assembly comprises at least one 1.5D ultrasound array, at least one 1.75D array, and / or at least one 2D array. The ultrasound assembly can comprise multiple ultrasound arrays (e.g., multiple 1.5D ultrasound arrays).

[0063] In some embodiments, the ultrasound assembly comprises a first ultrasound array with a field of view that can be adjusted by: adjusting an electronic focus of the first ultrasound array; translating and / or rotating the first ultrasound array; or both. The robotic manipulation assembly can be configured to perform the translation and / or rotation of the first ultrasound array. The treatment device can comprise a shaft that surrounds the first ultrasound array. The system can be configured to translate and / or rotate the first ultrasound array by: translating and / or rotating the shaft of the treatment device; translating and / or rotating the first ultrasound array within the shaft of the treatment device; or both. The first ultrasound array can be located in a first segment of the shaft of the treatment catheter, and the robotic manipulation assembly can be configured to twist the first segment of the shaft to change the field of view of the first ultrasound array. The robotic manipulation assembly can be configured to twist the first segment at least 45 degrees, or at least 90 degrees. The system can be configured to perform an electronic adjustment of the field of view of the first ultrasound array in a first plane, and to translate and / or rotate the first ultrasound array to adjust the field of view of the first ultrasound array in a second plane perpendicular to the first plane. The target tissue can comprise base of tongue tissue. The system can further comprise a hinge, ball joint, and / or other articulation element that can be attached to the first ultrasound array, and rotation of the first ultrasound array about the articulation element changes the field of view of the first ultrasound array. The articulation element can comprise a lockable articulation element. The articulation element can comprise a first articulation element and a second articulation element. The first articulation element can be configured to position the first ultrasound array along a tissue surface, and the second articulation element can be configured to change the field of view of the first ultrasound array. The first articulation element can comprise a lockable articulation element. The target tissue can comprise fibroid tissue, base of tongue tissue, soft palate tissue, tonsil tissue, and / or other tissue. The target tissue can comprise multiple volumes of target tissue, and the multiple volumes of target tissue can be treated by adjusting an electronic focus of the first ultrasound array. The multiple volumes of target tissue can be treated without translating and without rotating the first ultrasound array. The ultrasound assembly can comprise a first ultrasound array and a second ultrasound array, and the field of view of each ultrasound array can be modified by: electronic adjustment of the focus of the ultrasound array; translation and / or rotation of the ultrasound array; or both. The system can be configured to adjust the field of view of the first ultrasound array to compensate for patient movement. The first ultrasound array can comprise a 1.5D array, a 1.75D array, and / or a 2D array, and the system can be further configured to adjust the field of view by adjusting an electronic focus of the first ultrasound array.

[0064] In some embodiments, the ultrasound assembly comprises one or more ultrasound arrays, and each ultrasound array comprises one or more ultrasound transducers of the set of ultrasound transducers. The one or more ultrasound arrays can comprise two or more ultrasound arrays. The system can further comprise an electronic switch, and each ultrasound array can be configured to be independently activated via the electronic switch. The treatment device can comprise a shaft, and at least two ultrasound arrays of the two or more ultrasound arrays can be located on and / or within the shaft of the treatment device, the at least two arrays located in a sequential axial arrangement. The at least two ultrasound arrays can be configured to produce the image data via rotation of the associated array. The two or more ultrasound arrays can comprise a first ultrasound array and a second ultrasound array, and the first ultrasound array can be connected to the second ultrasound array via a hinge and / or other articulation element. The robotic manipulation assembly can be configured to change an angle between the first ultrasound array and the second ultrasound array via changing the hinge and / or other articulation element angle. A first ultrasound array of the one or more ultrasound arrays can be connected to an articulation element configured to allow adjustable positioning of the first ultrasound array relative to a tissue surface. The articulation element can comprise a ball joint, a hinge, or both. The tissue surface can comprise uterine wall tissue, base of tongue tissue, and / or other tissue surface. A first ultrasound array of the one or more ultrasound arrays can be connected to a first portion of a hinge and / or other articulation element. The treatment device can comprise a shaft, and a second portion of the articulation element can be connected to the shaft. The robotic manipulation assembly can be configured to adjust the angle between the shaft and the first ultrasound array. The robotic manipulation assembly can be connected to a second portion of the articulation element. The robotic manipulation assembly can be configured to position the at least one ultrasound array relative to a tissue surface based on a pressure signal. The tissue surface can comprise the uterine wall, a fibroid surface, or both. The treatment assembly can comprise a first ultrasound array of the one or more ultrasound arrays, and the first ultrasound array can be configured to perform the treatment procedure. The first ultrasound array can be further configured to produce the image data. The ultrasound assembly can comprise a second ultrasound array of the one or more ultrasound arrays, and the second ultrasound array can be configured to produce the image data. The second ultrasound array can be further configured to perform the treatment procedure. The first ultrasound array can be further configured to produce the image data.

[0065] In some embodiments, the robotic manipulation assembly comprises at least one robotically manipulatable arm.

[0064]

[0066] In some embodiments, the robotic manipulation assembly comprises at least two robotically manipulatable arms. The at least two robotically manipulated arms can comprise a first arm to travel along a first axis, and a second arm to travel along a second axis that can be relatively orthogonal to the first axis. The system can further comprise a second imaging device, and a first robotically manipulatable arm can be configured to be manipulated based on the image data produced by the ultrasound assembly, and a second robotically manipulatable arm can be configured to be manipulated based on image data produced by the second imaging device.

[0065]

[0067] In some embodiments, the robotic manipulation assembly comprises at least three robotically manipulatable arms.

[0066]

[0068] In some embodiments, the robotic manipulation assembly comprises at least one robotically manipulatable arm configured in a snake-robot arrangement.

[0067]

[0069] In some embodiments, the robotic manipulation assembly comprises one or more control cables, and translation of each control cable is configured to manipulate at least a portion of a first system component. Translation of a first control cable can be configured to manipulate a distal portion of the first system component.

[0068]

[0070] In some embodiments, a first system component comprises one or more magnetic elements, and the robotic manipulation assembly is configured to manipulate the system component by applying magnetic forces to the magnetic element. Application of the magnetic forces can be configured to manipulate a distal portion of the first system component.

[0069]

[0071] In some embodiments, the robotic manipulation assembly is configured to perform at least a 45 degree rotation of a first ultrasound array of the ultrasound assembly to increase the volume of target tissue ablated by the ultrasound assembly. The robotic manipulation assembly can be configured to perform at least a 180 degree rotation of the first ultrasound array of the ultrasound assembly to ablate a “full circle” of target tissue. The system can further comprise a substrate including a gel and having an umbrella geometry, and the substrate can be positioned between the robotic manipulation assembly and the first ultrasound array.

[0070]

[0072] In some embodiments, the system further comprises a force measurement assembly configured to measure the force applied to a first component of the system, and the first component of the system is configured to be manipulated by the robotic manipulation assembly. The robotic manipulation assembly can be configured to maintain the force applied to the first system component to a force below a threshold based on one or more measurements performed by the force measurement assembly. The first system component can comprise the treatment assembly. The first system component can comprise the ultrasound assembly. The force measurement assembly can be further configured to measure the force applied to a second component of the system. The first component of the system can comprise the ultrasound assembly, and the system can be configured to determine clinically relevant force thresholds related to the current anatomical location of the ultrasound assembly, and the robotic manipulation assembly can be configured to robotically manipulate the ultrasound assembly while preventing the ultrasound assembly applying a force to tissue that exceeds the force thresholds for that tissue.

[0071]

[0073] In some embodiments, the system further comprises a tissue manipulating assembly configured to manipulate the target tissue and / or other tissue of the patient. The robotic manipulating assembly can be configured to robotically manipulate the tissue manipulating assembly. The tissue manipulating assembly can comprise one or more tissue manipulating elements. The one or more tissue manipulating elements can comprise an element selected from the group consisting of a balloon; an expandable cage; an unfurlable element; an expandable element; and combinations thereof. The one or more tissue manipulating elements can comprise a first tissue manipulating element located in the treatment device. The tissue manipulating assembly can be configured to cause the treatment device to safely move along the uterine wall. The treatment device can comprise a shaft and a first tissue manipulating element comprising a balloon positioned on the shaft, and the balloon can be configured to contact the uterine wall.

[0072]

[0074] In some embodiments, the system further comprises a localization assembly comprising one or more localization elements, and the localization assembly is configured to produce anatomical location data related to the anatomical location of a first system component to be localized. The robotic manipulation assembly can be further configured to robotically manipulate the localization assembly. The one or more localization elements can comprise one or more magnetic markers. The localization assembly can be configured to determine the orientation of the first system component with at least 6 degrees of freedom. The one or more magnetic markers can comprise orthogonal coils. The localization assembly can be configured to determine roll, pitch, and yaw of the first system component. The one or more localization elements can comprise one or more visualizable markers. The one or more visualizable markers can comprise one, two, or more markers selected from the group consisting of: radiopaque markers; ultrasonically visible markers; electromagnetic markers; and combinations thereof. The one or more localization elements can comprise one or more electrically conductive markers. The localization assembly can be configured to provide 2D anatomical location information, 3D anatomical location information, or both. The localization assembly can be configured to provide anatomical location information of the treatment assembly and / or another portion of the treatment device. The localization assembly can be further configured to provide anatomical location information of an additional component of the system. The localization assembly can be further configured to provide anatomical location information of the ultrasound assembly. The system can further comprise an insertable probe, and the insertable probe can comprise the ultrasound assembly. The localization assembly can be configured to produce anatomical location information further based on the image data. The system can be configured to produce an image of the patient anatomy and the localized first system component in a registered arrangement.

[0073]

[0075] In some embodiments, the system is further configured to cause the robotic manipulating assembly to perform the robotic manipulation further based on the anatomical location information produced by the localization assembly.

[0074]

[0076] In some embodiments, the system further comprises an ablation assessment assembly configured to: produce data related to the ablation of the target tissue and / or other tissue; predict quality of a future ablation; or both. The robotic manipulation assembly can be further configured to robotically manipulate the ablation assessment assembly. The system can be configured to prevent a tissue treatment if a prediction of the ablation assessment assembly is below a threshold.

[0075]

[0077] In some embodiments, the system further comprises a controller and a memory storage component coupled to the controller, and the memory storage component stores instructions to perform an algorithm. The algorithm can comprise an artificial intelligence (Al) algorithm. The algorithm can be configured to produce an anatomical model based on at least the image data. The anatomical model can comprise two or more sets of 3D images that can be stitched together. The anatomical model can be based on one or more landmarks identified in the image data. The algorithm can be further configured to identify one or more features of interest in the anatomical model. The one or more features of interest can comprise one or more features selected from the group consisting of: fibroid tissue; tumor tissue; margin tissue; blood vessel; duct; target tissue; safety margin tissue; non-target tissue; and combinations thereof. The algorithm can be further configured to automatically perform the robotic manipulation based on the anatomical model and the one or more features of interest. The algorithm can be further configured to prevent a manual robotic manipulation based on the anatomical model and the one or more features of interest. The algorithm can be further configured to prevent a delivery of energy based on the anatomical model and one or more features of interest. The algorithm can be further configured to prevent a delivery of energy based on a current position and / or orientation of an energy delivery component relative to target tissue and / or the current position and / or orientation of the energy delivery component relative to non-target tissue. The algorithm can be further configured to prevent a delivery of energy based on image data that can comprise blood flow information. The ultrasound assembly can be configured to provide the image data comprising the blood flow information, and the blood flow information can comprise doppler blood flow information. The algorithm can be further configured to identify non-target tissue in the anatomical model, and the system can be configured to limit energy delivery to the non-target tissue using the anatomical model. The non-target tissue can comprise: blood vessel tissue; tissue proximate a blood vessel; nerve tissue; and / or tissue proximate a nerve. The algorithm can be further configured to identify a blood vessel proximate to the target tissue. The system can be configured to ablate the blood vessel that is proximate the target tissue. The algorithm can be configured to compensate for tissue movement when creating the anatomical model. The image data can comprise image data collected prior to the occurrence of the tissue movement. The algorithm can be further configured to adjust the trajectory of a system component based on an assessment of the tissue movement. The algorithm can be further configured to predict patient movement and / or other tissue movement. The system can further comprise a second imaging device, and the algorithm can be further configured to create the image data by combining first image data received from the ultrasound assembly and second image data received from the second imaging device. The second imaging device can comprise an MRI. The anatomical model can comprise a 3D model comprising a high-resolution portion and one or more low-resolution portions. The system can be configured to gather additional data and to transform at least one low-resolution portion of the 3D model to a portion with increased resolution. The robotic manipulation assembly can be configured to robotically manipulate the ultrasound assembly and / or another system component to gather the additional data. The system can comprise a library of anatomical model templates, and the algorithm can be configured to produce the anatomical model based on one or more of the anatomical templates and on the image data. The robotic manipulation assembly can be configured to automatically manipulate the treatment device based on the anatomical model. The automatic manipulation can be further based on location of target tissue. The automatic manipulation can be further based on a pre-determined trajectory map configured to optimize image data collection. The algorithm can comprise an artificial intelligence algorithm configured to determine the pre-determined trajectory map. The algorithm can comprise an artificial intelligence algorithm configured to determine a sequence of treatment locations. The algorithm can be configured to produce the anatomical model based on properties of one or more materials in the acoustic pathway of the ultrasound assembly when producing the image data. The algorithm can be further configured to cause the robotic manipulation assembly to cause a system component to navigate within a portion of the patient’s anatomy included in the anatomical model. The system component can comprise the ultrasound assembly, the treatment device, and / or another system component configured to treat the target tissue. The algorithm can be configured to stitch and / or otherwise combine multiple images and / or multiple sets of image data to create the anatomical model. The algorithm can comprise an artificial intelligence algorithm that can be configured to identify one or more volumes of target tissue to be ablated, stimulated, and / or otherwise treated by the system. The one or more volumes of target tissue can comprise: one or more fibroids; one or more volumes of tongue tissue; one or more volumes of soft palate tissue; one or more volumes of tonsil tissue; and / or one or more volumes of tumor tissue, such as one or more volumes of tumor tissue positioned behind a bone. The system can be configured to gather second image data from an MRI, and the algorithm can be further configured to produce the anatomical model based on the second image data. The target tissue can comprise: one or more fibroids; one or more volumes of tongue tissue; one or more volumes of soft palate tissue; one or more volumes of tonsil tissue; and / or one or more volumes of tumor tissue, such as one or more volumes of tumor tissue positioned behind a bone. The algorithm can be configured to determine a desired change in a field of view of a first ultrasound array of the ultrasound assembly, and the system can be configured to perform an electronic focus adjustment of the ultrasound assembly; translate and / or rotate the first ultrasound array; or both. The system can further comprise at least one pressure sensor and / or other sensor, and each sensor can be configured to produce a sensor signal, and the algorithm can be configured to determine a force applied to a tissue surface by a first ultrasound array of the ultrasound assembly, the force determination based on: the sensor signals; the image data; or both. The robotic manipulation assembly can be configured to reposition the first ultrasound array if the applied force exceeds a threshold. The algorithm can be configured to modify the field of view of an ultrasound array of the ultrasound assembly based on patient movement detected by the algorithm. The algorithm can be configured to detect the patient movement by analyzing the image data. The system can further comprise one or more pressure sensors configured to produce a pressure signal, and the algorithm can be configured to detect patient movement by analyzing the pressure signal. The target tissue can comprise a first volume of tissue, and the algorithm can be configured to determine if the field of view of a first ultrasound array is sufficient to treat the first volume of tissue in its entirety. If the algorithm determines the field of view of the first ultrasound array is insufficient to treat the first volume of tissue in its entirety, the algorithm can be further configured to cause the robotic manipulation assembly to translate and / or rotate the first ultrasound array to change the field of view to treat the first volume of tissue in its entirety. The target tissue can comprise a first volume of tissue, and the algorithm can be configured to minimize movement of the ultrasound assembly in treating the first volume of tissue in its entirety. The target tissue can comprise multiple volumes of target tissue, and the algorithm can be configured to analyze the image data and based on the analysis cause the robotic manipulation assembly to robotically manipulate an energy delivery component along a trajectory to treat the multiple volumes of target tissue. The system can be configured to gather additional image data during the robotic manipulation of the energy delivery component, and the algorithm can be configured to adjust the trajectory based on an analysis of the additional image data. The additional image data can comprise data of lower resolution and / or higher resolution than the resolution of the image data. The algorithm can comprise a bias. The algorithm can be configured to determine a trajectory map used by the robotic manipulation assembly to robotically manipulate a system component, and the algorithm can be configured to bias one or more trajectories of the trajectory map toward one or more tissue types and / or away from one or more tissue types and / or one or more anatomical locations.

[0076]

[0078] In some embodiments, the system further comprises a processing unit comprising at least one processor, and the processing unit is operatively connected to the robotic manipulation assembly and is configured to control the robotic manipulation assembly to provide a treatment procedure to the patient according to a treatment plan that includes treating multiple volumes of tissue within a target tissue volume. The robotic manipulation assembly can be configured to provide the treatment procedure by: controlling the robotic manipulation assembly to mechanically position a first field of view of the ultrasound assembly within a first of the multiple volumes of tissue to be treated; delivering ultrasound energy with the ultrasound assembly to treat the first volume of tissue; controlling the robotic manipulation assembly to mechanically position a second field of view of the ultrasound assembly within a second of the multiple volumes of tissue to be treated; and delivering ultrasound energy with the ultrasound assembly to treat the second volume of tissue. The treatment plan can be based on the image data. The image data can comprise at least doppler ultrasound data.

[0077]

[0079] In some embodiments, the system further comprises a functional element comprising one or more sensors, one or more transducers, and / or one or more other functional elements. The robotic manipulation assembly can be further configured to robotically manipulate the functional element. The functional element can comprise a tissue manipulating element. The tissue manipulating element can comprise a balloon. The functional element can comprise one or more optical fibers configured to provide the treatment device and / or other system component geometry data and / or treatment device and / or other system component orientation data. The treatment device can comprise the one or more optical fibers. The one or more optical fibers can be configured to provide: 3D dimensional coordinate data; roll data; pitch data; and / or yaw data.

[0078]

[0080] In some embodiments, the system further comprises a user interface configured to provide information to a user and / or receive information from a user. The user interface can comprise a component selected from the group consisting of: user input device; user output device; display; touchscreen; button; switch; lever; footswitch; user-mountable assembly; head-mountable assembly; and combinations thereof. The user interface can comprise a user- mountable assembly configured to attach to a first user, and the user-mountable assembly can be configured to provide information to the first user and / or receive information from the first user. The user-mountable assembly can be configured to mount to the head of the first user. The user-mountable assembly can be configured to track movement of the first user. The system can be configured to correlate the movement to a gesture, and the gesture can be assigned to a first function of the system. The correlation of the gesture can be further based on input from an additional user input component of the system. The first function can comprise a movement of the robotic manipulation assembly. The first function can comprise creation of an image. The first function can comprise delivery of energy. The user interface can include a user feedback component configured to provide alert information and / or other information to an operator of the system. The alert information and / or other information can comprise haptic feedback, audible feedback, or both. The alert information and / or other information can comprise information related to temperature of target tissue, temperature of non-target tissue, or both. The alert information and / or other information can comprise information related to positioning of an energy delivery component of the system relative to: target tissue, non-target tissue, or both. The feedback provided can comprise visual feedback comprising images of the patient’s anatomy and / or images of one or more system components such as images indicating the position of one or more system components relative to target tissue and / or relative to non-target tissue. The alert information and / or other information can comprise information related to the level of ablation of target tissue.

[0079]

[0081] In some embodiments, the system further comprises a console configured to operably attach to the treatment device, the robotic manipulation assembly, or both. The console can comprise an ultrasound module for providing drive signals to the ultrasound assembly.

[0080]

[0082] In some embodiments, the system further comprises a sensor comprising an assembly of one or more sensors, and each sensor is configured to provide a sensor signal. The robotic manipulation assembly can be further configured to robotically manipulate the sensor. The treatment device can comprise the sensor. The ultrasound assembly can comprise the sensor. The sensor can comprise at least one pressure sensor. The at least one pressure sensor can comprise at least four pressure sensors. Based on the sensor signal from each pressure sensor, the robotic manipulation assembly and / or other system component can be configured to: maintain proper contact with tissue, such as to reduce presence of air bubbles between the ultrasound assembly and tissue; prevent undesired force being applied to tissue by an operator and / or the robotic manipulation assembly; or both. The sensor can comprise one or more thermocouples, infrared cameras, and / or other temperature sensors. The sensor can comprise one or more pressure sensors.

[0081]

[0083] In some embodiments, the system further comprises a surgical tissue treatment tool configured to treat tissue of the patient. The robotic manipulation assembly can be further configured to robotically manipulate the surgical tissue treatment tool. The surgical tissue treatment tool can be configured to treat tissue via a delivery of energy comprising energy in a form selected from the group consisting of: radiofrequency energy, microwave energy, and / or other electromagnetic energy; laser energy and / or other light energy; thermal energy, such as hot fluid energy and / or cryogenic energy; ultrasound energy; mechanical energy; chemical energy; and combinations thereof. The treatment device can comprise the surgical tissue treatment tool, and the surgical tissue treatment tool can be configured to deliver energy to perform the treatment of the target tissue. The image data can be used to create a trajectory map for the surgical tissue treatment tool. The trajectory map can comprise and / or can be based on information selected from the group consisting of: target tissue location information; non-target tissue location information; trajectory depth information; ablation depth information; margin information; blood vessel location information; and combinations thereof. The surgical tissue treatment tool can be configured to treat a first volume of target tissue, and the ultrasound assembly can be configured to treat a second volume of the target tissue. The first volume of target tissue can be a larger tissue volume than the second volume of target tissue. The first volume of target tissue can comprise at least 50% of the volume of a fibroid, and the second volume of target tissue can comprise one or more margins of a fibroid. The second volume of target tissue can comprise a non-vascular volume of tissue. The ultrasound assembly can be configured to treat one or more other volumes of target tissue, and each of the other volumes of target tissue can be less than the first volume of target tissue. The ultrasound assembly can be configured to perform a cauterization. The surgical tissue treatment tool can comprise a radiofrequency delivery needle and / or other needle, and the cauterization performed by the ultrasound assembly cauterizes a puncture tract of the radiofrequency delivery needle and / or other needle. The ultrasound assembly can be configured to deliver a plane of HIFU energy that marks a boundary in tissue, and the surgical tissue treatment tool treats a volume of target tissue based on the marked boundary. The plane of HIFU energy can be configured to ablate margin tissue of the target tissue.

[0082]

[0084] In some embodiments, the system further comprises a body introduction device configured to aid in delivery of a system component to a location within the body of the patient. The robotic manipulation assembly can be configured to robotically manipulate the body introduction device. The body introduction device can comprise a device selected from the group consisting of: sheath; trocar; vascular introducer; laparoscopic port; endoscope; and combinations thereof. The treatment device can be configured to be slidingly inserted through the body introduction device and into the patient.

[0083]

[0085] In some embodiments, the system further comprises an augmented reality device. The augmented reality device can be configured to provide images and / or other information to an operator in an augmented reality arrangement, such as images and / or other information that is based on the image data and / or other data produced by the system.

[0084]

[0086] In some embodiments, the system further comprises a second imaging device comprising one or more imaging devices configured to produce additional image data. The robotic manipulation assembly can be further configured to robotically manipulate the second image device. The treatment device can comprise the second imaging device. The second imaging device can comprise one, two, or more devices selected from the group consisting of: fluoroscope or other X-ray based imaging device; CT scanner; MRI; PET scanner; ultrasound imager; OCT and / or other light-based imaging device; and combinations thereof. The second imaging device can comprise an MRI configured to identify target tissue for treatment. The target tissue can comprise one or more fibroids. The second imaging device can comprise an optical fiber. The treatment device can comprise the optical fiber. The image data can comprise photoacoustic image data. The image data can comprise data representing the presence of blood vessels.

[0085]

[0087] In some embodiments, the system further comprises an agent, and the agent comprises one or more agents configured to be delivered to the patient. The system can further comprise a delivery element configured to deliver the agent to the patient, and the robotic manipulation assembly can be further configured to robotically manipulate the delivery element.

[0086]

[0088] In some embodiments, the system further comprises a cooling device configured to: cool tissue of the patient; cool a system component; or both. The cooling device can comprise a cooling element, and the robotic manipulation assembly can be further configured to robotically manipulate the cooling element. In some embodiments, the system further comprises a light source and a light delivery element, and the system is configured to produce a first set of image data via: (1) delivery of ultrasound and receiving of reflections of that delivered ultrasound; and (2) the delivery of pulsed light and the receiving of ultrasound that results from the delivery of the pulsed light. The robotic manipulation assembly can manipulate the treatment device based on the first set of image data

[0087]

[0089] In some embodiments, the system further comprises an algorithm that is configured to cause the robotic manipulation assembly to orient the treatment assembly away from locations in which energy is delivered to non-target tissue

[0088]

[0090] In some embodiments, the treatment assembly is configured to deliver focused ultrasound energy configured to perform a histotripsy procedure on target tissue.

[0091] In some embodiments, the system further comprises an agent comprising one, two, or more tissue markers. The agent can comprise one, two, or more tissue markers selected from the group consisting of: photoacoustic tags; ultrasonically -reflective markers; visualizable markers; magnetic markers; and combinations thereof. The robotic manipulation assembly can be configured to robotically manipulate a system component based on image data including the location of the one, two, or more tissue markers.

[0089]

[0092] In some embodiments, the robotic manipulation assembly comprises a robotically-manipulatable arm that is coupled to a shaft of the treatment device through a controllable hinge, and the treatment device comprises an ultrasound array comprising the set of one or more ultrasound transducers. The controllable hinge can be configured to vary the angle between the robotically-manipulatable arm and the shaft of the treatment device to orient the ultrasound array toward target tissue. The controllable hinge can be configured to constrain the contact force between the treatment device and the tissue to remain between minimum-force and / or maximum-force thresholds. The ultrasound array can be mounted on a flexible substrate and is operatively connected to a control cable that is actuated by the robotic manipulation assembly to transition the array between a linear geometry and a curvilinear geometry.

[0090]

[0093] In some embodiments, the robotic manipulation assembly comprises at least three independently controllable robotically-manipulatable arms, each arm operably attached to a respective treatment device that includes an ultrasound assembly. The system can be further configured to generate image data with an ultrasound assembly on a first arm and to robotically manipulate at least one other arm based on that image data.

[0091]

[0094] According to another aspect of the present inventive concepts, a method of performing a medical procedure on a patient comprises: selecting a system of the present inventive concepts; producing image data using at least the ultrasound array; and treating target tissue of the patient by robotically manipulating a component of the system using the produced image data.

[0092]

[0095] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example. INCORPORATION BY REFERENCE

[0093]

[0096] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference. The content of all publications, patents, and patent applications mentioned in this specification are herein incorporated by reference in their entirety for all purposes.

[0094] BRIEF DESCRIPTION OF THE DRAWINGS

[0095]

[0097] Fig. 1 illustrates a block diagram of an embodiment of a system for performing a medical procedure on a patient using a robotic manipulation assembly, consistent with the present inventive concepts.

[0096]

[0098] Fig. 1A illustrates a block diagram of another embodiment of a system for performing a medical procedure on a patient using a robotic manipulation assembly, consistent with the present inventive concepts.

[0097]

[0099] Figs. 2A and 2B illustrate schematic views of a ID ultrasound array and a 1.5D ultrasound array, respectively, consistent with the present inventive concepts.

[0098]

[0100] Fig 3 illustrates an anatomical view of a treatment device positioned relative to target tissue to be treated, consistent with the present inventive concepts.

[0099]

[0101] Fig. 4 illustrates an anatomical view of a treatment device positioned relative to target tissue via a robotic manipulation assembly, consistent with the present inventive concepts.

[0100]

[0102] Fig. 5 illustrates an anatomical view of a treatment device positioned and manipulated via a robotic manipulation assembly, consistent with the present inventive concepts.

[0101]

[0103] Fig. 6 illustrates a system for performing a medical procedure on a patient using a robotic manipulation assembly comprising three independently controllable arms, consistent with the present inventive concepts.

[0102] DETAILED DESCRIPTION OF THE DRAWINGS

[0103]

[0104] Reference will now be made in detail to the present embodiments of the technology, examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and / or alternatives of the embodiments described herein.

[0104]

[0105] It will be understood that the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") or "containing" (and any form of containing, such as "contains" and "contain") when used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0105]

[0106] It will be further understood that, although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers and / or sections, these limitations, elements, components, regions, layers and / or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.

[0106]

[0107] It will be further understood that when an element (also referred to as a “component” herein) is described as being "on", "attached", "connected" or "coupled" to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being "directly on", "directly attached", "directly connected" or "directly coupled" to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g. "between" versus "directly between," "adjacent" versus "directly adjacent," etc.).

[0107]

[0108] As used herein, the terms “operably attached”, “operably connected”, “operatively coupled” and similar terms related to attachment of components shall refer to attachment of two or more components that results in one, two, or more of electrical attachment; fluid attachment; magnetic attachment; mechanical attachment; optical attachment; sonic attachment; and / or other operable attachment arrangements. The operable attachment of two or more components can facilitate the transmission between the two or more components of power; signals; electrical energy; fluids or other flowable materials; magnetism; mechanical linkages; light; sound such as ultrasound; and / or other materials and / or components.

[0108]

[0109] It will be further understood that when a first element is referred to as being "in", "on" and / or "within" a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g. within a wall of the second element); positioned on an external and / or internal surface of the second element; and combinations of one or more of these.

[0109]

[0110] As used herein, the term “proximate”, when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and / or within the second component or location. For example, a component positioned proximate an anatomical site (e.g. a blood or other fluid delivery location), shall include components positioned near to the anatomical site, as well as components positioned in, on and / or within the anatomical site.

[0110]

[0111] Spatially relative terms, such as "beneath," "below," "lower," "above," "upper", “under” and the like may be used to describe an element and / or feature's relationship to another element(s) and / or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and / or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as "below" and / or "beneath" other elements or features would then be oriented "above" the other elements or features. The device can be otherwise oriented (e.g. rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0111]

[0112] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence. Correspondingly, the terms “prevent”, “preventing”, and “prevention”, as well as “avoid” and “avoiding”, shall include the acts of “reduce”, “reducing”, and “reduction”, respectively.

[0112]

[0113] The term "and / or" where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example "A and / or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[0114] The term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number.

[0113]

[0115] The terms “and combinations thereof’ and “and combinations of these” can each be used herein after a list of items that are to be included singly or collectively. For example, a component, process, and / or other item selected from the group consisting of: A; B; C; and combinations thereof, shall include a set of one or more components that comprise: one, two, three or more of item A; one, two, three or more of item B; and / or one, two, three, or more of item C.

[0114]

[0116] In this specification, unless explicitly stated otherwise, “and” can mean “or”, and “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature can have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature can have only one or two of A, B, or C.

[0115]

[0117] As used herein, when a quantifiable parameter is described as having a value “between” a first value X and a second value Y, it shall include the parameter having a value of: at least X, no more than Y, and / or at least X and no more than Y. For example, a length of between 1 and 10 shall include a length of at least 1 (including values greater than 10), a length of less than 10 (including values less than 1), and / or values greater than 1 and less than 10.

[0116]

[0118] The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of’ according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component.

[0117]

[0119] As used herein, the terms “about” or “approximately” shall refer to ± 20% of a stated value.

[0118]

[0120] As used herein, the term “threshold” refers to a maximum level, a minimum level, and / or range of values correlating to a desired or undesired state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values, such as to cause a desired effect (e.g. efficacious therapy) and / or to prevent and / or otherwise reduce (hereinafter “prevent”) an undesired event (e.g. a device and / or clinical adverse event). In some embodiments, a system parameter is maintained above a first threshold (e.g. above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g. below a second temperature threshold to prevent undesired tissue damage). In some embodiments, a threshold value is determined to include a safety margin, such as to account for patient, user, and / or operator variability, system variability, tolerances, and the like. As used herein, “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and / or outside of a range of threshold values.

[0119]

[0121] As described herein, “room pressure” shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. Positive pressure includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. Negative pressure includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described hereabove.

[0120]

[0122] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross-sectional area as the cross section of the component being described.

[0121]

[0123] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.

[0122]

[0124] As used herein, the term “functional element” is to be taken to include one or more elements constructed and arranged to perform a function. A functional element can comprise a sensor and / or a transducer. In some embodiments, a functional element is configured to deliver energy. In some embodiments, a functional element is configured to treat tissue (e.g. a functional element configured as a treatment element). Alternatively or additionally, a functional element (e.g. a functional element comprising a sensor) can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter (e.g. a tissue geometry parameter); a patient environment parameter; and / or a system parameter. In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g. to gather data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g. to deliver therapeutic energy and / or a therapeutic agent). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of deliver energy; extract energy (e.g. to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record and / or otherwise sense a parameter such as a patient physiologic parameter or a system parameter; and combinations of one or more of these. A functional element can comprise a fluid and / or a fluid delivery system. A functional element can comprise a reservoir, such as an expandable balloon or other fluid-maintaining reservoir. A “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as a diagnostic and / or therapeutic function. A functional assembly can comprise an expandable assembly. A functional assembly can comprise one or more functional elements.

[0123]

[0125] The term “transducer” where used herein is to be taken to include any component or combination of components that receives energy or any input, and produces an output. For example, a transducer can include an electrode that receives electrical energy, and distributes the electrical energy to tissue (e.g. based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g. a transducer comprising a light emitting diode or light bulb), sound (e.g. a transducer comprising a piezo crystal configured to deliver ultrasound energy); pressure (e.g. an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g. a transducer comprising a motor or a solenoid); magnetic energy; and / or a different electrical signal (e.g. different than the input signal to the transducer). Alternatively or additionally, a transducer can convert a physical quantity (e.g. variations in a physical quantity) into an electrical signal. A transducer can include any component that delivers energy and / or an agent to tissue, such as a transducer configured to deliver one or more of electrical energy to tissue (e.g. a transducer comprising one or more electrodes); light energy to tissue (e.g. a transducer comprising a laser, light emitting diode and / or optical component such as a lens or prism); mechanical energy to tissue (e.g. a transducer comprising a tissue manipulating element); sound energy to tissue (e.g. a transducer comprising a piezo crystal); chemical energy; electromagnetic energy; magnetic energy; and combinations of one or more of these.

[0124]

[0126] As used herein, the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and / or opening.

[0127] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials.

[0125]

[0128] As used herein, the term “user interface” can comprise one or more interfaces, each interface comprising one or more components configured to receive an input from a user, “user input device” herein, and / or one or more components configured to provide output to a user, “user output device” herein. An input device can comprise one, two, three, or more components selected from the group consisting of: keyboard; a mouse; a button; a switch; a lever; a keypad such as a membrane keypad; a joystick; a touchscreen display; a microphone; a brain-machine-interface (e.g., a thought-control device); a camera, such as a camera with eye tracking, motion tracking, gesture identification, and / or other image processing capability configured to identify user input; a motion capture device, such as a camera and / or a device including one or more accelerometers; a virtual input device, such as a virtual device comprising ultrasonic, image capture, and / or motion-based sensing of user inputs; a physiologic input sensor, such as a sensor configured to provide an input signal based on a user action, such as flexure of a muscle proximate the sensor; a scent detector, such as a detector configured to identify a pheromone or other scent produced by the user; other input component; and combinations of these. An output device can comprise one, two, three, or more components selected from the group consisting of: a visual output component such as a light and / or a display such as a touchscreen display; an audible output component such as a buzzer and / or a speaker; a haptic output component such as a vibrational transducer and / or an ultrasonic device configured to produce a tactile output; a brain-machine-interface; an augmented reality (AR) and / or a virtual reality (VR) output device, such as glasses or a headset including a non-transparent display, a transparent display, and / or a “heads up” display where information is presented to the user in an overlay manner; a scent output device configured to produce an aromatic output, such as a computerized scent output; other output component; and combinations of these.

[0126]

[0129] The terms “data” and “information” are used interchangeably herein.

[0127]

[0130] As used herein, the term “access” can refer to providing access to a location within a patient for delivery of fluids or other materials, and / or removal of fluids or other materials.

[0128]

[0131] As used herein, a “blood vessel of an organ” can comprise a blood vessel that supplies blood to the organ, such as an artery that supplies blood to the organ, a blood vessel on or within the organ, such as an artery, vein, and / or capillary within the organ, and / or a blood vessel that receives blood from the organ, such as a vein that receives blood from the organ.

[0129]

[0132] As used herein, “therapy planning”, “therapy plan”, and the like, can comprise a set of one or more medical procedures (e.g., diagnostic and / or therapeutic procedures) to be performed using the systems, devices, and methods of the present inventive concepts. A therapy plan can include: the anatomical locations of one or more portions of tissue to be treated, and / or one or more anatomical locations of one or more portions of tissue to which treatment should be avoided; the settings of energy delivery (e.g., ultrasound delivery) to be used in a diagnostic procedure (e.g., an imaging procedure or other diagnostic procedure); the settings of energy delivery (e.g., ultrasound delivery) to be used in a therapeutic procedure (e.g., an ablation procedure, stimulation procedure, and / or other therapeutic procedure); the identity of one or more clinicians to perform a medical procedure; and combinations of these.

[0130]

[0133] As used herein, “field of view”, or “FOV”, can refer to the solid angle in space through which energy, such as ultrasound energy is or can be delivered, such as to ablate and / or otherwise modify tissue (“ablate tissue” herein), and / or to image tissue (e.g., by transmitting energy and collected reflected energy). Also as used herein, “collective field of view”, or simply “field of view” or “FOV” can describe the collective views achieved by translating and / or rotating the energy delivery element (e.g., an ultrasound array as described herein).

[0131]

[0134] As used herein, “acoustic pathway” can refer to the paths in volumes of tissue through which energy (e.g., ultrasound energy) travels.

[0132]

[0135] It is appreciated that certain features of the inventive concepts, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the inventive concepts which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.

[0133]

[0136] It is to be understood that at least some of the figures and descriptions of the inventive concepts have been simplified to focus on elements that are relevant for a clear understanding of the inventive concepts, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the inventive concepts. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the inventive concepts, a description of such elements is not provided herein.

[0134]

[0137] Terms defined in the present disclosure are only used for describing specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in singular forms are intended to include plural forms as well, unless the context clearly indicates otherwise. All of the terms used herein, including technical or scientific terms, have the same meanings as those generally understood by an ordinary person skilled in the related art, unless otherwise defined herein. Terms defined in a generally used dictionary should be interpreted as having meanings that are the same as or similar to the contextual meanings of the relevant technology and should not be interpreted as having ideal or exaggerated meanings, unless expressly so defined herein. In some cases, terms defined in the present disclosure should not be interpreted to exclude the embodiments of the present disclosure.

[0135]

[0138] Provided herein are systems, devices, and methods for performing a medical procedure (also referred to as a “clinical procedure” herein) on a patient, such as a diagnostic procedure, a therapeutic procedure (also referred to as a “treatment procedure” herein), and / or other medical procedure. The systems can include a robotic manipulation assembly for robotically manipulating one or more components of the system, such as a robotic manipulation performed manually by an operator, automatically by the system, or both. The systems can include an ultrasound array, a photoacoustic imaging device, and / or another imaging device, each for producing image data, and the robotic manipulation assembly can perform the robotic manipulation based on the produced image data.

[0136]

[0139] Referring now to Fig. 1, a system for performing a medical procedure on a patient is illustrated. System 10 can be configured to perform a medical procedure on a patient, such as a diagnostic procedure, a treatment procedure (also referred to as a therapeutic procedure), or both. The patient can comprise a human and / or other mammalian patient, “patient” herein. System 10 comprises one, two, or more treatment-performing devices, treatment device 100 as shown. As used herein, a “user”, “operator”, and / or “clinician” of system 10 can refer to a doctor, nurse, clinician and / or other healthcare professional, that uses treatment device 100 and / or other component of system 10 to perform the medical procedure.

[0137]

[0140] System 10 can further comprise one, two, or more assemblies, robotic manipulation assembly 300 shown. Each robotic manipulation assembly 300, also referred to as RMA 300, can be configured to robotically manipulate treatment device 100 and / or another component of system 10 (e.g., robotically manipulate all or a portion of device 100 and / or another component of system 10 as described herein). The robotic manipulation of a system 10 component can comprise a movement of that component selected from the group consisting of translation, such as advancement, retraction, movement left and / or right, movement side-to-side, and / or movement up and / or down; rotation; expansion; contraction; bending and / or other articulation; twisting; and / or other manipulation of a system 10 component.

[0138]

[0141] System 10 can further comprise one, two, or more ultrasound assemblies, ultrasound assembly 800 shown. In some embodiments, treatment device 100 comprises all or a portion of ultrasound assembly 800. Ultrasound assembly 800 can comprise one, two, or more devices configured to deliver and / or receive ultrasound energy (also referred to as simply “ultrasound”). Each ultrasound assembly 800 comprises one, two, or more ultrasound arrays, ultrasound array 850, and each array 850 can comprise one or more ultrasound transducers, UST 855 shown. Each UST 855 can be configured to deliver ultrasound, receive ultrasound, or both. Each UST 855 can comprise a piezo-based ultrasound transducer, or a capacitive micromachined ultrasonic transducer (CMUT). In some embodiments, array 850 comprises at least one UST 855 that is piezo-based, and at least one UST 855 that is a CMUT. RMA 300 can be configured to robotically manipulate ultrasound array 850 (e.g., robotically manipulate an ultrasound array 850 comprising one, two, or more ultrasound arrays). Ultrasound assembly 800 can be of similar construction and arrangement to assembly 800 described in reference to Fig. 1 A, Figs. 2A-B, and / or otherwise herein.

[0139]

[0142] Treatment device 100 can comprise one, two, or more assemblies for treating tissue, treatment assembly 150 shown. Treatment assembly 150 can be configured to deliver one, two, or more forms of energy, as described herein. In some embodiments, treatment assembly 150 is configured to perform a diagnosis (e.g., in addition to a treatment or instead of a treatment), such as a diagnosis of a medical condition of a patient, a diagnosis (e.g., an assessment) of a procedure being performed by system 10, and / or other diagnosis. In some embodiments, treatment assembly 150 comprises all or a portion of ultrasound assembly 800 (e.g., a treatment assembly 150 comprising one, two, or more ultrasound arrays 850 of ultrasound assembly 800), such as when treatment assembly 150 is configured to deliver ultrasound energy (e.g., for performing a treatment and / or for imaging), receive reflected ultrasound energy (e.g., for imaging), or both. In some embodiments, treatment assembly 150 is configured to expand, contract, and / or otherwise change shape (e.g., a shape change caused and / or controlled by RMA 300). Treatment assembly 150 can be of similar construction and arrangement to assembly 150 described in reference to Fig. 1A and / or otherwise herein.

[0140]

[0143] System 10 can comprise one, two, or more consoles and / or other modular assemblies, console 200 shown. Console 200 can be configured to operably connect to treatment device 100, ultrasound assembly 800, robotic manipulation assembly 300, and / or another component of system 10, such as when the attachment comprises an electrical attachment (e.g., to transfer power, data, and / or other signals), a fluid attachment (e.g. to transfer cooling fluid, hydraulic fluid, pneumatic fluid, and / or other fluid), an optical attachment (e.g. to transfer laser light and / or other light, such as when system 10 is configured to perform photoacoustic imaging, as described herein); a mechanical attachment (e.g. to operate a mechanical linkage); an acoustic attachment (e.g., to transfer sound), and / or other attachment. Console 200 can be configured to operably connect to treatment device 100, ultrasound assembly 800, and / or another system 10 component, for example to transmit power and / or signals to, and / or receive signals from the connected component. Console 200 can provide a user interface (e.g., as described herein) for the input of commands and / or other information from a user of system 10, and / or for the output of information from system 10 to a user. Console 200 can be of similar construction and arrangement as console 200 described in reference to Fig. 1 A and / or otherwise herein.

[0141]

[0144] System 10 can comprise one, two, or more modules configured to perform a function, processing unit 50 shown. Treatment device 100, ultrasound assembly 800, console 200, RMA 300, and / or another component of system 10 can comprise all or a portion of a processing unit 50. Processing unit 50 can be of similar construction and arrangement as processing unit 50 described in reference to Fig. 1 A and / or otherwise herein.

[0142]

[0145] System 10 can comprise one, two, or more modules configured to provide a user interface, user interface 60 shown. Treatment device 100, ultrasound assembly 800, console 200, RMA 300, and / or another component of system 10 can comprise all or a portion of a user interface 60. User interface 60 can be of similar construction and arrangement as user interface 60 described in reference to Fig. 1 A and / or otherwise herein. RMA 300 can be configured to robotically manipulate user interface 60, such as to manipulate all or a portion of interface 60 to provide better access to a clinician or other user of system 10 during the performance of a medical procedure.

[0146] System 10 can comprise one, two, or more elements, assemblies, and / or other components configured to perform a function, functional element 99 shown. Treatment device 100, ultrasound assembly 800, console 200, and / or another component of system 10 can comprise all or a portion of one or more functional elements 99. Functional element 99 can be of similar construction and arrangement as functional element 99 described in reference to Fig. 1A and / or otherwise herein. RMA 300 can be configured to robotically manipulate one or more functional element 99.

[0143]

[0147] In some embodiments, system 10 is configured to perform an imaging procedure and / or otherwise collect image data, image data ID, such as when one or more UST 855 deliver ultrasound to tissue, and one or more UST 855 (e.g., similar and / or dissimilar UST 855) receive reflections of the delivered ultrasound, such that system 10 can produce one or more images of tissue (e.g., target tissue as described herein) based on the timing and / or other parameters of the delivered and received ultrasound. In some embodiments, system 10 (e.g., when including an assembly that produces pulsed laser light) is configured to perform photoacoustic imaging, as described herein. Each imaging procedure performed using system 10 can include robotic manipulation of treatment device 100, ultrasound assembly 800, and / or one or more other system 10 components using RMA 300.

[0144]

[0148] In alternative and / or additional embodiments, system 10 is configured to perform a “treatment procedure”, such as a treatment procedure including the delivery of ultrasound energy. System 10 can be configured to perform a treatment procedure comprising a tissue treatment procedure, such as a tissue ablation, tissue stimulation, and / or other tissue treatment procedure including the delivery of energy (e.g., ultrasound energy, radiofrequency energy, and / or one or more other forms of energy as described herein) to tissue. In some embodiments, delivered energy can comprise ultrasound energy that is delivered to tissue by one or more UST 855, such as ultrasound energy delivered to “target tissue” to be ablated, stimulated, and / or otherwise treated. In some embodiments, system 10 is configured to deliver ultrasound energy to activate a pharmaceutical and / or other agent; and / or to enhance the efficacy of a pharmaceutical and / or other agent. Each treatment procedure performed using system 10 can include robotic manipulation of treatment device 100, ultrasound assembly 800, and / or one or more other system 10 components using RMA 300.

[0145]

[0149] In some embodiments, system 10 is configured to perform a “combined imaging and treatment procedure” which comprises the performance of one or more imaging procedures, as well as one or more tissue ablation, tissue stimulation, and / or other tissue treatment procedures. In these embodiments, system 10 can be configured to simultaneously produce image data ID (e.g., such as to create images of tissue, an agent, and / or an implant within the patient), and deliver a treatment (e.g., a treatment comprising ablating and / or otherwise modifying tissue, and / or a treatment modifying an implant and / or agent). Alternatively, or additionally, system 10 can be configured to sequentially (e.g., in a repeating manner) create image data ID (e.g., such as to create images of tissue, an agent, and / or an implant within the patient), and deliver a treatment (e.g., a treatment comprising ablating and / or otherwise modifying tissue, and / or a treatment modifying an implant and / or agent). In the combined imaging and treatment procedures, an energy delivery and / or other parameters of a treatment procedure (e.g., a tissue treatment procedure) can be determined (e.g., automatically determined by system 10) based on image data ID collected simultaneously with, and / or prior to the performance of the treatment. Each combined imaging and treatment procedure performed using system 10 can include robotic manipulation of treatment device 100, ultrasound assembly 800, and / or one or more other system 10 components using RMA 300.

[0146]

[0150] In some embodiments, system 10 is configured to perform: imaging of the prostate of a patient, such as to perform a diagnostic analysis of benign prostatic hyperplasia (BPH) and / or other undesired condition of the prostate; ablation and / or other treatment of the prostate, such as to perform ablation of cancerous tissue of the prostate and / or tissue associated with BPH; or both.

[0147]

[0151] In some embodiments, system 10 is configured to perform: imaging of a fibroid (e.g., a uterine fibroid), such as to perform a diagnostic analysis of the fibroid and / or surrounding tissue; ablation and / or other treatment of the fibroid; or both.

[0148]

[0152] In some embodiments, system 10 is configured to perform: imaging of the tongue, a tonsil, and / or soft palate tissue of a patient, such as to perform a diagnostic analysis of sleep apnea; ablation and / or other treatment of tongue, tonsil, and / or soft palate tissue, such as to perform ablation of tissue causing patient airway obstruction; or both.

[0149]

[0153] In some embodiments, system 10 is configured to perform: imaging (e.g., used to perform a diagnostic analysis); treatment (e.g., ablation, stimulation, and / or other tissue treatment); or both, such as when one or both procedures are performed at an anatomical location selected from the group consisting of: prostate (e g., to treat BPH); uterus (e.g., to treat endometriosis); nasal passageway and / or tongue (e.g., to treat sleep apnea); an organ such as bladder, bone, brain, heart, intestine, pancreas, kidney, liver, lung, skin, and / or stomach; and combinations of these.

[0150]

[0154] In some embodiments, system 10 is configured to perform: imaging (e.g., used to perform a diagnostic analysis); treatment (e.g., ablation, stimulation, and / or other tissue treatment); or both, such as when one or both procedures are performed to diagnose and / or treat a tissue type selected from the group consisting of: BPH tissue; tumor tissue; nerve tissue; tissue associated with a cardiac arrhythmia; tissue associated with sleep apnea and / or blockage of an airway; abnormal and / or otherwise undesired tissue; and combinations of these.

[0151]

[0155] System 10 can be configured to avoid affecting certain volumes of tissue, “nontarget tissue” herein. In some embodiments, system 10 is configured to perform a medical procedure (e.g., a treatment procedure, a diagnostic procedure, or both) in which damage and / or other undesired effect upon non-target tissue is prevented or at least reduced (“reduced”, “prevented” or “avoided” herein). For example, in treatment of prostate tissue, non-target tissue can include tissue of the wall of the urethra, tissue of a seminal vesicle, pudendal and / or other nerve tissue, rectal wall tissue, and / or tissue of the ejaculatory duct. Non-target tissue can comprise nerve tissue. In the treatment (e.g., ablation) of tumor tissue, non-target tissue can comprise non-tumor tissue (e.g., healthy tissue). In some embodiments, tissue immediately proximate target tissue comprises “safety margin tissue”, and tissue beyond the safety margin tissue comprises non-target tissue. In these embodiments, safety margin tissue can comprise tissue to which treatment (e.g., ablation) is not particularly desired but not necessary to avoid. In some embodiments, RMA 300 is manipulated by an algorithm 55 that comprises a bias. In these embodiments, the bias of algorithm 55 can cause RMA 300 to manipulate treatment device 100 in a manner to avoid undesired treatment of non-target tissue (e.g., orient energy delivery of treatment assembly 150 such as to avoid any significant delivery of energy toward non-target tissue).

[0152]

[0156] As described herein, system 10 can be configured to perform both a diagnostic procedure (e.g., a procedure including the production of one or more images of tissue or other material on and / or within the patient), as well as a treatment procedure (e.g., a procedure in which target tissue is ablated, stimulated, and / or otherwise treated), such as when treatment device 100, ultrasound assembly 800, and / or another component of system 10 is robotically manipulated by RMA 300 as described herein. In these embodiments, the diagnostic procedure (e.g., imaging) and treatment procedure can be performed simultaneously, sequentially, or both. In some embodiments, imaging and tissue treatment (e.g., ablation) are performed in an alternating arrangement, such as when tissue treatment is adjusted (e.g., one or more ultrasound delivery and / or other treatment parameters are adjusted) based on an analysis of one or more images (also referred to as “image data ID” herein). Adjustment of treatment parameters can be performed by system 10 (e.g., via an algorithm of system 10 as described herein), by a clinician (e.g., based on information provided by system 10), or via a combination of system 10 and a clinician (e.g., when a clinician is required to confirm the acceptability of a parameter or parameter change “suggested” by system 10).

[0153]

[0157] System 10 can be configured to perform a medical procedure comprising a procedure selected from the group consisting of: a benign prostatic hyperplasia treatment procedure; an endometriosis treatment procedure; a fibroid treatment procedure such as category 1 fibroid treatment procedure; a fallopian tube treatment procedure; a sleep apneareducing procedure; a tumor treatment procedure; a biopsy procedure; an agent delivery procedure; a transabdominal procedure; a transvaginal procedure; and combinations thereof. System 10 can be configured to perform a fibroid treatment procedure in which at least 50% of each fibroid is ablated. System 10 can be configured to perform an ablation using HIFU energy and / or other focused ultrasound energy (as described herein), such as when at least a portion of the delivery of ultrasound energy is automatically initiated. System 10 can be configured to ablate tissue, denature tissue, remove tissue, dissolve tissue, and / or cause the necrosis of tissue (singly, or collectively, “ablate tissue” herein) via the delivery of various forms of ultrasound energy delivery, such as HIFU energy delivery, focused ultrasound configured to perform a histotripsy procedure (a procedure that uses focused ultrasound to break down and destroy targeted tissue via the creation of a “bubble cloud”), and / or other ultrasound energy delivery. System 10 can be configured to perform a biopsy procedure, such as when functional element 99 and / or 199 (each described herein) comprise a biopsy needle (e.g., a biopsy needle robotically manipulated by RMA 300). System 10 can be configured to perform an agent delivery procedure, such as a procedure in which an agent is delivered by a delivery element (e.g., agent 30 is delivered by delivery element 35, each described herein). In these agent delivery procedures, ultrasound assembly 800 can be configured to deliver ultrasound energy to cells to modify the absorption of the agent by the cells. In these embodiments, the delivery element 35 and / or ultrasound assembly 800 can be robotically manipulated by RMA 300.

[0158] In some embodiments, system 10 is configured to perform a diagnostic and / or treatment procedure comprising the delivery of ultrasound energy (e.g., via a robotically manipulated treatment device 100) to activate a pharmaceutical and / or other agent; and / or to enhance the efficacy of a pharmaceutical and / or other agent.

[0154]

[0159] In some embodiments, system 10 is configured to perform a medical procedure comprising the delivery of ultrasound energy to an implant and / or an agent (e.g., via a robotically manipulated treatment device 100), such as to supply power to and / or otherwise modify the implant and / or agent.

[0155]

[0160] Target tissue treated using system 10 can comprise two, three, four, or more volumes of target tissue. Each volume of target tissue can be adjacent to another volume of target tissue, and any pair of volumes of target tissue can be non-adjacent. In some embodiments, two or more volumes of target tissue can comprise two or more fibroids; two or more volumes of tissue of the tongue; two or more volumes of soft palate tissue; two or more volumes of tonsil tissue; and / or two or more tumors. Target tissue can comprise prostatic tissue, such as when non-target tissue (e.g., tissue to which the treatment should avoid adversely affecting) comprises tissue types selected from the group consisting of seminal duct; verumontanum; sphincter; calcification-tissue; and combinations of these. Target tissue can comprise tissue types selected from the group consisting of fibroid tissue; tissue of the tongue, tonsil, and / or soft palate; blood vessel tissue, such as blood vessel tissue proximate other target tissue to be ablated, stimulated, and / or otherwise treated; tumor tissue, such as tumor tissue associated with the skin, lung, liver, pancreas, brain, breast, bladder, prostate, ovary and / or other organ; soft tissue tumor tissue; benign tumor tissue; malignant tumor tissue; and combinations of one, two, or more of these.

[0156]

[0161] In some embodiments, system 10 and / or one or more of its components, are of similar construction and arrangement as the systems and components described in applicant’s co-pending applications: United States Application Serial Number 18 / 640,305 (Docket No. USD-001-US-CON2), titled “Medical Device with CMUT Array and Solid State Cooling, and Associated Methods and Systems”, filed April 19, 2024; United States Patent Application Serial Number 18 / 039,978 (Docket No. USD-003-US), titled “Tissue Interface System”, filed June 2, 2023; United States Patent Application Serial Number 18 / 564,181, (Docket No. USD- 004-US), titled “Tissue Treatment System”, filed November 27, 2023; United States Patent Application Serial Number 18 / 714,768 (Docket No. USD-008-US), titled “Capacitive Micromachined Ultrasonic Transducer” filed May 30, 2024; and / or International PCT Patent Application Serial Number PCT / US2024 / 018763 (Docket No. USD-010-PCT) filed March 7, 2024; the contents of each of which are herein incorporated by reference in their entirety for all purposes.

[0157]

[0162] System 10, treatment device 100, and / or other components of system 10 of Fig. 1 can be of similar construction and arrangement as the similar components described in reference to Figs. 1 A, 3, 4, 5, 6 and / or otherwise herein.

[0158]

[0163] Referring additionally to Fig. 1A, another embodiment of a system for performing a medical procedure is illustrated, consistent with the present inventive concepts. System 10 of Fig. 1 A can be of similar construction and arrangement as system 10 of Fig. 1 and / or otherwise described herein. For example, system 10 of Fig. 1A can include treatment device 100, ultrasound assembly 800 including ultrasound array 850 and ultrasound transducers 855, each as shown, as well as processing unit 50, user interface 60, functional element 99, console 200, and / or robotic manipulation assembly 300, also as shown.

[0159]

[0164] In some embodiments, system 10 further comprises one or more additional imaging devices, second imaging device 960 shown where each device is configured to produce image data ID. RMA 300 can be configured to robotically manipulate second imaging device 960. Treatment device 100 can comprise all or a portion of second imaging device 960. Second imaging device 960 can comprise one, two, or more devices selected from the group consisting of fluoroscope or other X-ray imaging device; CT scanner; MRI; PET scanner; ultrasound imager; optical coherence tomography (OCT); photoacoustic; and / or other light-based imaging device; and combinations thereof. Second imaging device 960 can comprise an MRI configured to identify target tissue for treatment (e.g., to identify one or more fibroids for treatment). Second imaging device 960 can comprise a light source (e.g., a laser light source), an optical fiber (e.g., one, two, three or more optical fibers), and a light delivery element (e.g., one, two, three, or more lenses or other light delivery elements oriented in a forward-facing and / or side-facing arrangement), such as when treatment device 100 comprises one, two or more optical fibers and one, two, or more lenses of second imaging device 960. A second imaging device 960 comprising an optical fiber and lens can be configured to produce photoacoustic image data, such as when the data is produced in combination with data received from ultrasound assembly 800. The photoacoustic image data can comprise data representing the presence (e.g., location) of one or more blood vessels, and / or one or more photoacoustic tags (e.g., a photoacoustic marker configured to attach to a particular tumor tissue and / or other tissue type), as described herein.

[0165] In some embodiments, treatment device 100 includes second imaging device 960 (e.g., device 960 is integral to device 100), such as when device 960 comprises a photoacoustic imaging device. In these embodiments, second imaging device 960 can comprise a functional element 199 comprising a light-delivering element (e.g., one or more lenses positioned on the side and / or end of shaft assembly 130) and an optical fiber (e.g., an optical fiber optically connected to the one or more lenses and extending proximally through shaft assembly 130). In these embodiments console 200 can comprise a functional element 299 comprising a laser (e.g., a pulsed laser) that optically connects to the optical fiber of functional element 199 of treatment device 100. Light produced by the laser-based functional element 299 is delivered to tissue or other material by the one or more lenses of functional element 199, and resultant ultrasound is received by one or more USTs 855 (e.g., USTs 855 integral to treatment device 100), thus producing photoacoustic image data.

[0160]

[0166] As described herein, ultrasound assembly 800, second imaging device 960, and / or one or more other components of system 10 can be configured to produce (also referred to as “record”, “gather”, “collect” and the like) image data, image data ID herein. In some embodiments, the image data ID comprises photoacoustic image data. In some embodiments, image data ID is used by system 10 (e.g., via algorithm 55) to produce an anatomical model of one or more anatomical locations of the patient.

[0161]

[0167] System 10 can comprise one, two, or more devices configured to perform a treatment procedure, surgical tissue treatment tool 920 shown. Surgical tissue treatment tool 920, also referred to as STTT 920 herein, can be configured to ablate and / or otherwise treat tissue of the patient. In some embodiments, STTT 920 is used in an open surgical procedure. Alternatively or additionally, STTT 920 can be used in a non-surgical procedure, such as a percutaneous procedure or a procedure in which STTT 920 is advanced through a natural orifice of a patient.

[0162]

[0168] System 10 can comprise one, two, or more cooling devices, cooling device 950 shown, that are configured to lower the temperature (“cool”) a portion of treatment device 100, ultrasound assembly 800, RMA 300, STTT 920, and / or another component of system 10. Cooling device 950 can be operably attached (e.g., fluidly attached) to at least treatment device 100 and / or ultrasound assembly 800, such as when supplying a cooling fluid to cooling module 160 of treatment device 100. For example, cooling module 160 can comprise one or more fluid pathways (e.g., tubes, lumens, and the like) that are fluidly attached to cooling device 950. These fluid pathways can be positioned and arranged in close proximity to treatment assembly 150, ultrasound array 850, and / or another component of device 100 to be cooled, and / or the fluid pathways can be positioned such as to cool tissue that is proximate device 100 and / or another system 10 component delivering energy to tissue.

[0163]

[0169] As described herein, system 10 can include one or more assemblies, robotic manipulation assembly 300 shown, that are configured to robotically manipulate a set of one or more components of system 10. Robotic manipulation assembly 300, also referred to as RMA 300, can be configured to “robotically manipulate” treatment device 100, treatment assembly 150, ultrasound assembly 800, cooling device 950, STTT 920, second imaging device 960, functional element 99 and / or 199 (e.g., a light-delivering functional element), and / or another component of system 10. The robotic manipulation performed by RMA 300 can be based on image data ID collected by system 10, such as image data collected by ultrasound assembly 800, second imaging device 960, and / or another imaging device. In some embodiments, RMA 300 is configured to robotically manipulate an imaging device, such as ultrasound assembly 800, second imaging device 960, and / or another imaging device, such as when the robotic manipulation is performed based on at least some image data ID (e.g., image data ID that is based on delivered ultrasound, delivered light (e.g., photoacoustic image data), or both, as described herein) that is produced concurrent with (e.g., gathered, recorded, and / or otherwise produced within 5 seconds, 10 seconds, and / or 30 seconds) the robotic manipulation.

[0164]

[0170] Robotic manipulation of a system 10 component performed by RMA 300 can comprise a “robotic manipulation” of a system 10 component comprising: translation (e.g., advancement; retraction; movement left and / or right; movement side-to-side; and / or movement up and / or down); rotation; expansion; contraction; bending and / or other articulation; twisting; and / or other manipulation of a system 10 component. Robotic manipulation of a system 10 component performed by RMA 300 can be performed automatically (e.g., with little or no command input from an operator). Alternatively or additionally, robotic manipulation of a system 10 component performed by RMA 300 can be performed via operator control (e.g., using one or more user input devices, such as input device 61 of user interface 60 described herein). The robotic manipulation of a system 10 component performed by RMA 300 can comprise robotic manipulation of an imaging device of system 10 (e.g., ultrasound assembly 800, second imaging device 960, and / or another imaging device of system 10), wherein the imaging device is configured to produce additional image data ID; and the robotic manipulation of the imaging device is based on additional image data ID that is produced concurrent with the robotic manipulation (e.g., to perform real-time image-based robotic manipulation). In some embodiments, manipulation of treatment device 100 and / or another component of system 10 is performed by RMA 300 based on image data ID comprising both image data produced via the delivery of pulsed light (e.g., via a light delivering functional element) and the receiving of ultrasound (e.g., via one or more USTs 855) that results from the pulsed light delivery (photoacoustic image data), as well as image data produced via the delivery of ultrasound (e.g., via one or more USTs 855) and the receiving of reflections of the delivered ultrasound (e.g., via the same and / or different USTs 855 that delivered the ultrasound), each as described herein.

[0165]

[0171] Processing unit 50 can comprise one or more modules, where each module can be configured to perform, control, and / or monitor one or more of the functions of system 10 (e.g., as described herein). One or more devices or other components of system 10 can comprise all or a portion of a processing unit 50, such as when all or a portion of a processing unit 50 is integral to: treatment device 100, ultrasound assembly 800, console 200, RMA 300, second imaging device 960, STTT 920, and / or another component of system 10. For example, processing unit 50 can be configured to perform and / or facilitate one or more processes, data collections, data analyses, data transfers, signal processing functions, agent deliveries, positioning of access elements, flow monitoring, monitoring of one or more patient parameters, and / or other functions of system 10 (“functions of system 10”, “system 10 functions” or simply “system functions” herein). Processing unit 50 can comprise one or more electronic elements, electronic assemblies, and / or other electronic components, such as components selected from the group consisting of: microprocessors; microcontrollers; state machines; memory storage components; analog-to-digital converters; rectification circuitry; filters and other signal conditioners; sensor interface circuitry; transducer interface circuitry; and combinations of one, two, or more of these. For example, processing unit 50 can include at least one processor and at least one memory storage component, such as processor 51 and memory 52, respectively, each shown. Memory 52 can be coupled to processor 51, and memory 52 can store one or more sets of computer instructions, instructions 53 shown. Instructions 53 can comprise instructions used by processor 51 to perform one or more algorithms of system 10. For example, system 10 can comprise one or more algorithms, algorithm 55 shown, that are performed by processor 51. Additionally, or alternatively, instructions 53 can comprise instructions for running one or more applications of system 10, for example application 56 shown. Processing unit 50 can be configured to “run” application 56, such that application 56 can initiate, modify, stop, and / or otherwise control the performance of various functions of treatment device 100 and / or of another component system 10. In some embodiments, application 56 is configured to receive input from a user of system 10, for example via a user interface (e.g., user interface 60 described herein). In some embodiments, algorithm 55 can comprise one or more machine learning, neural net, and / or other artificial intelligence algorithms (“Al algorithm” herein). All or a portion of one or more processing units 50 can be integrated into one, two, or more of the various components of system 10, such as treatment device 100, ultrasound assembly 800, console 200, RMA 300, STTT 920, a server (e.g., server 80 described herein), and / or other component of system 10. Performance of a function of system 10 is described hereabove as being performed by processing unit 50. Alternatively, or additionally, the performance of a function of system 10 can be described herein, interchangeably, as being performed by algorithm 55 and / or system 10. For example, “algorithm 55 being configured to perform an action, a routine, and / or another function” can be interpreted as processing unit 50 and / or system 10 being configured to perform the action, routine, and / or other function, and vice versa.

[0166]

[0172] As described herein, processing unit 50 (e.g., a processing unit of treatment device 100, ultrasound assembly 800, RMA 300, STTT 920, console 200, and / or a processing unit of another system 10 component), can be configured to perform one or more algorithms, algorithm 55 described herein. In some embodiments, system 10 is configured to produce a volumetric multi-dimensional image of tissue (e.g., an anatomical model as described herein) based on image data ID collected by system 10, and algorithm 55 comprises an artificial intelligence algorithm or other algorithm that is configured to: characterize one or more tissue types (e.g., identify fibroid, nerve, and / or blood vessel tissue); identify tissue areas to avoid treating; and / or suggest tissue areas to be treated. In these data, the image data ID used by algorithm 55 can comprise: image data produced via the delivery of pulsed light (e.g., via a light delivering functional element) and the receiving of ultrasound (e.g., via one or more USTs 855) that results from the pulsed light delivery (photoacoustic image data); image data produced via the delivery of ultrasound (e.g., via one or more USTs 855) and the receiving of reflections of the delivered ultrasound (e.g., via the same and / or different USTs 855 that delivered the ultrasound); or both.

[0167]

[0173] Algorithm 55 can comprise an artificial intelligence algorithm or other algorithm that is configured to assess image data ID to maintain a focal spot (e.g., a particular field of view) for delivery of ablation energy. The algorithm 55 can be configured to modify delays of signals delivered to the ultrasound transducers to maintain the focal spot.

[0168]

[0174] Algorithm 55 can comprise an artificial intelligence algorithm or other algorithm that is configured to identify one or more ablation patterns that reduce edema or other undesired effects of the delivery of ablation energy to the target tissue.

[0169]

[0175] User interface 60 can comprise one or more user interfaces configured to provide and / or receive information to and / or from, respectively, a user of the system (e.g., a clinician and / or other user of system 10). One or more devices or other components of system 10 can comprise all or a portion of a user interface 60, such as when all or a portion of a user interface 60 is integral to: treatment device 100, ultrasound assembly 800, console 200, RMA 300, STTT 920, second imaging device 960, and / or another component of system 10. User interface 60 can include one or more user input components and / or output components, as described herein. For example, user interface 60 can comprise a keyboard, mouse, touchscreen, and / or other human interface and / or other input component, user input device

[0170] 61. In some embodiments, user interface 60 comprises a speaker, indicator light, haptic transducer and / or other human interface and / or other output component, user output device

[0171] 62. In some embodiments, user output device 62 comprises a video output component, such as display 63 shown. Display 63 can comprise a touchscreen display, for example when user input device 61 and user output device 62 collectively comprise display 63. In some embodiments, processing unit 50 is configured to provide an interactive graphical interface, GUI 65, such as a graphical user interface provided by application 56. GUI 65 can be displayed (e.g., displayed to a user of system 10) via display 63. In some embodiments, user interface 60 and / or GUI 65 comprise a virtual reality and / or augmented reality interface. One or more components of system 10 can comprise one or more portions of a user interface 60, such as treatment device 100, ultrasound assembly 800 console 200, RMA 300, STTT 920, and / or other components of system 10 described herein.

[0172]

[0176] Communication module 70 can comprise one or more communication modules configured to transmit and / or receive data. One or more devices or other components of system 10 can comprise all or a portion of a communication module 70, such as when all or a portion of a communication module 70 is integral to: treatment device 100, ultrasound assembly 800, console 200, RMA 300, STTT 920, and / or another component of system 10. Communication module 70 can be configured to provide communication between (e.g., transfer commands, delivery information, patient information, and / or other data between) two or more components of system 10, such as via wired and / or wireless communication. For example, communication module 70 can include one or more transmitters and / or receivers, transceiver 71 shown. Transceiver 71 can comprise a wireless transceiver, such as a Bluetooth transceiver, a Near Field Communication (NFC) transceiver, a Wi-Fi transceiver, a cellular transceiver, a satellite-connected transceiver, and / or other short-range and / or long- range wireless transceiver. A wireless connection can include a short-range wireless connection, such as an NFC connection and / or a Bluetooth low energy (BLE) connection. In some embodiments, communication module 70 is configured to transfer data via an acoustic signal, such as an acoustic signal that is outside of the auditory range of the user. In some embodiments, communication module 70 is configured to communicate via one or more wired and / or wireless networks, such as network 75 shown. Network 75 can include a wireless network, such as a cellular network, LAN, WAN, VPN, the Internet, and / or other wireless network connecting two or more devices. In some embodiments, network 75 comprises a wired network, and / or a network including wired and wireless devices.

[0173]

[0177] Communication module 70 can be configured to transfer data between at least a first component of system 10 and at least a second component of system 10, as described herein. In some embodiments, the first component of system 10 comprises treatment device 100 and / or ultrasound assembly 800 (e.g., or both, such as when treatment device 100 comprises ultrasound assembly 800). The second component can comprise another component of system 10, for example console 200, RMA 300, STTT 920, and / or second imaging device 960.

[0174]

[0178] Treatment device 100 can comprise an elongate device with a handle assembly, handle 110, which can connect to an extending shaft portion, shaft assembly 130, each as shown.

[0175]

[0179] In some embodiments, treatment device 100 comprises a user interface 106 comprising at least a portion of user interface 60 of system 10. User interface 106 of treatment device 100 can be positioned on handle 110. User interface 106 can comprise an alert element (e.g., alert element 49 of alert assembly 40 positioned in handle 110), such as a tactile transducer configured to vibrate to alert an operator of system 10 of a warning or other alert condition.

[0176]

[0180] Shaft assembly 130 can comprise one or more flexible portions (e.g., two flexible portions surrounding a relatively stiff portion). One or more outer surfaces of shaft assembly 130 can comprise one or more coatings, such as a lubricous coating. Treatment device 100 can comprise a catheter device. In some embodiments, treatment device 100 (e.g., a treatment device 100 comprising all or a portion of ultrasound assembly 800) can comprise one, two, three, or more devices selected from the group consisting of: a catheter device; a surgical device; a device configured for insertion through a laparoscopic introducer; a device configured for insertion through a vascular introducer; a device configured for insertion through an endoscope; a device configured for insertion through a surgical incision; and combinations of these.

[0177]

[0181] In some embodiments, treatment device 100, ultrasound assembly 800, RMA 300, and / or STTT 920 are constructed and arranged to be inserted through a lumen of introducer device 930 comprising a device selected from the group consisting of: an introducer such as an introducer catheter; a foley catheter; a sheath; a laparoscopic port; an endoscope; and combinations thereof. Treatment device 100, ultrasound assembly 800, RMA 300, and / or STTT 920 can be configured to be inserted through a second medical device that is configured to be inserted through the bulbar urethra.

[0178]

[0182] Treatment device 100, ultrasound assembly 800, RMA 300, and / or STTT 920 can comprise a distal portion that is configured to be inserted into and / or through (e.g., at least a portion of) one or more lumens, openings, and / or other body conduits (“body conduits” herein) of a patient, such as a body conduit selected from the group consisting of: the urethra; the vaginal canal; a blood vessel; a duct; an airway; an intestine; the throat; the esophagus; the mouth; the anus; the ear; a nostril; and combinations of these.

[0179]

[0183] In some embodiments, treatment device 100 includes at least a portion of processing unit 50, at least a portion of user interface 60, and / or at least a portion of communication module 70, such as when treatment device 100 comprises processing unit 105, user interface 106, and / or communication module 107, respectively, each shown.

[0180]

[0184] In some embodiments, treatment device 100 comprises one or more lumens and / or components (e.g., tubes), cooling module 160 shown, which are configured to cool one or more portions of treatment assembly 150 (e.g., a treatment assembly comprising one or more ultrasound arrays 850) and / or another portion of treatment device 100. In some embodiments, cooling module 160 is operably connected (e.g., fluidly connected) to cooling device 950 (e.g., when cooling device 950 provides cooling fluid to one or more lumens or other flow conduits of treatment device 100) such that treatment assembly 150 and / or another portion of device 100 can be cooled by the cooling fluid. Cooling module 160 can be mechanically coupled to and / or otherwise positioned proximate to treatment assembly 150. Cooling module 160 can be configured to cool treatment assembly 150, tissue proximate or treated by treatment assembly 150, or both. Cooling module 160 can comprise: a thermoelectric cooling module; a solid-state cooling module; a cooling element, such as cooling element 955 and / or a thermal conductor (e.g., a solid or stranded thermal conductor configured to draw heat energy away from the cooling element 955 and / or assembly 150); a fluid pathway (e.g., a fluid pathway configured to receive cooling fluid from cooling device 950). In some embodiments, cooling device 950 is configured to cool one or more ultrasound arrays 850 that are not included in treatment assembly 150.

[0181]

[0185] In some embodiments, treatment device 100 comprises one or more modules for sensing, sensor module 120, which can include one or more sensors, sensor 125, each as shown. In some embodiments, sensor 125 comprises one or more thermocouples and / or other temperature sensors, such as temperature sensors used to monitor temperature of one or more portions of treatment assembly 150 and / or another portion of treatment device 100, such as to allow closed-loop cooling of device 100 via cooling device 950 (e.g. when sensor module 120 provides temperature information to cooling device 950). Sensor 125 can comprise one, two, three or more sensors selected from the group consisting of temperature sensor, pressure sensor; strain gauge; accelerometer; physiologic sensor; GPS sensor; ultrasound sensor (e.g., CMUT or piezo-based ultrasound transducer); light sensor; and combinations thereof The sensor module 120 can be configured to record one or more parameters of target tissue, one or more parameters of non-target tissue, or one or more parameters of both, such as one or more temperature parameters, pressure parameters, and / or other parameters. The sensor module 120 can be configured to record one or more parameters related to the performance of a system 10 components, such as an ultrasound transducer (e.g., a CMUT or piezo-based ultrasound transducer) used to confirm adequate delivery of ultrasound energy, or a light sensor used to confirm adequate delivery of light (e.g., via a photoacoustic imaging device as described herein). Sensor module 120 can comprise at least one sensor 125 that is configured to articulate, such as an articulating sensor that is configured to rotate and record data, such as while avoiding applying forces to tissue proximate the at least one articulating sensor. In some embodiments, RMA 300 is configured to articulate sensor 125.

[0182]

[0186] Treatment device 100 includes treatment assembly 150 which can include one or more ultrasound transducers, transducers 855 of ultrasound assembly 800, as described herein. For example, transducers 855 can comprise one or more capacitive micromachined ultrasound transducers (CMUTs), one or more piezo transducers, or one or more of each.

[0187] Ultrasound array 850 can comprise multiple arrays 850, each array comprising one or more ultrasound transducers 855. Each array 850 can comprise a ID array (as described in reference to Fig. 2A), a 1.5D array (e.g., as described in reference to Fig. 2B), or a different type of ultrasound array. The multiple ultrasound arrays 850 can comprise multiple independently activatable arrays, and the arrays 850 can be constructed and arranged to ablate tissue, such as target tissue with a volume of at least 40cc, such as at least 80cc, 120cc, and / or 150cc. Treatment device 100 and / or ultrasound assembly 800 can be configured to be guided via images provided by ultrasound assembly 800, and to deliver ablation energy to tissue, such as when ultrasound assembly 800 delivers ultrasound energy while array 850 is positioned within the prostatic urethra. Multiple arrays 850 can be configured to independently create images of the patient (e.g., of patient tissue and / or any implants within the patient), and the images can used to provide: guidance information; diagnostic information; and / or treatment planning information. Treatment device 100, ultrasound assembly 800, console 200, RMA 300, STTT 920, and / or another component of system 10 can comprise a set of electrical connections and a multiplexor, where the multiplexor is configured to selectively connect the electrical connections to each of multiple ultrasound arrays 850. A first ultrasound array 850a can be configured to transmit ultrasound, and a second ultrasound array 850b can be configured to receive the transmitted ultrasound (e.g., receive reflections of the transmitted ultrasound), such as when the received ultrasound is used to detect and / or measure the relative position between the first ultrasound array 850a and the second ultrasound array 850b. In some embodiments, first array 850a, second array 850b, or both, are configured to both transmit ultrasound, and receive the ultrasound that the particular array transmitted (e.g., receive reflections of the ultrasound transmitted by that particular array). A first ultrasound array 850a, a second ultrasound array 850b, or both, can each comprise an array of at least 128 CMUT ultrasound transducers. The relative position between a first ultrasound array 850a and a second ultrasound array 850b can be used by system 10 (e.g., by algorithm 55) to determine signal delays, wherein the delays are used in creating images using both the first ultrasound array 850a and the second ultrasound array 850b. Alternatively, or additionally, the relative position between the first ultrasound array 850a and the second ultrasound array 850b can be used to determine delays, and the delays can be used in delivering ablation energy to tissue using both the first ultrasound array 850a and the second ultrasound array 850b.

[0183]

[0188] In some embodiments, a set of one or more transducers 855 of one or more ultrasound arrays 850 can be configured to switch between an “imaging mode” and a “treatment mode”, such as when switching between an imaging mode in which imaginglevel ultrasound energy is transmitted to tissue and reflections are received from tissue, and a treatment mode in which ablation or other treatment-level ultrasound energy is delivered to ablate and / or otherwise treat tissue. The switching between the imaging mode and the treatment mode can occur in a time period of no more than 6 seconds, 100 msec, and / or 10 msec. In some embodiments, the switching between the imaging mode and the treatment mode can occur in a time period of no more than 1msec (e.g., when performing elastography during ablation, stimulation, and / or other tissue treatment). Treatment device 100, ultrasound assembly 800, console 200, RMA 300, STTT 920, and / or another component of system 10 can comprise a switching assembly that is configured to perform the switching of the ultrasound transducers 855 between the imaging mode and the ablating mode. The switching assembly can comprise switches with a resistance of no more than 3 ohm per channel, a capacitance of no more than 50pF per channel, or both. The switching assembly can comprise imaging drive circuitry, ablation drive circuitry, and a set of switches configured to switch between connecting the one or more ultrasound transducers 855 to the imaging drive circuitry and the ablation drive circuitry. The set of switches can comprise micro-electro- mechanical systems (MEMS) switches and / or low-resistance, low-capacitance switches. The imaging drive circuitry can comprise a set of receive amplifiers, where a receive amplifier can be positioned proximal to and proximate to each switch of the set of switches. The switching assembly can further comprise a set of bias tees, each bias tee can be positioned distal to each switch of the set of switches, and each bias tee can be configured to provide a DC bias to the associated ultrasound transducer 855. The switching assembly can comprise an adjustable overvoltage protection circuit. The ablation drive circuitry can comprise an overshoot protection circuit. The set of switches can comprise a corresponding set of pulldown resistors, and each resistor can comprise a resistance of at least IMOhm and can be configured to dissipate undesired voltage present at each switch. The switching assembly can be configured to operably connect and disconnect each of the ultrasound transducers 855 to a bias voltage source. The switching assembly can be configured to test for short-circuits by connecting an ultrasound transducer 855 to the bias voltage source and measuring the current delivered by the bias voltage source.

[0184]

[0189] Ultrasound array 850 can comprise a set of two or more ultrasound transducers 855 that are arranged in a forward-looking arrangement, a side-looking arrangement, or both.

[0185]

[0190] In some embodiments, at least a portion of ultrasound array 850 is surrounded by a thermally-insulative layer (e.g., a portion of shaft assembly 130 comprising a thermally- insulative layer when treatment device 100 comprises one or more ultrasound arrays 850). The thermally-insulative layer can comprise a layer constructed and arranged to prevent undesired damage to tissue via an ultrasound array 850 that is at a temperature above body temperature.

[0186]

[0191] In some embodiments, treatment device 100 includes a functional element 199 that comprises an inflatable and / or otherwise expandable anchoring element (e.g., an inflatable balloon), such as an anchoring element configured to anchor an integrated ultrasound array 850 relative to tissue (e.g., to create a reference point to be used in 2D or 3D image creation and / or to prevent undesired motion of ultrasound array 850 during imaging, tissue treatment, and / or other procedure performed using device 100). In some embodiments, RMA 300 is configured to robotically manipulate the anchoring element. In some embodiments, functional element 199 comprises an expandable anchoring element configured to be expanded while positioned in the bladder of the patient (e.g., to anchor a portion of device 100 in the bladder). In some embodiments, functional element 199 comprises a removable sleeve, and the removable sleeve comprises the expandable anchor. In the embodiments, the removable sleeve can further comprise a thermally-insulative layer, such as a layer configured to prevent undesired damage to tissue via an ultrasound array 850 that is at a temperature above body temperature.

[0187]

[0192] In some embodiments, treatment device 100 includes a shaft assembly 130 comprising a proximal portion, a distal portion, and a lumen, lumen 135 shown. Lumen 135 can extend from the proximal portion to the distal portion of shaft assembly 130. Lumen 135 can extend from a location at and / or otherwise proximate a proximal end of shaft assembly 130 and / or a location of handle 110, where lumen 135 can extend to a location at and / or otherwise proximate a distal end of shaft assembly 130. In some embodiments, lumen 135 is configured to slidingly receive an elongate device, such as to slidingly receive a second medical device (e.g., STTT 920 and / or second imaging device 960). For example, lumen 135 can be configured to slidingly receive a second medical device comprising a cystoscope and / or a photoacoustic device. In some embodiments, lumen 135 is configured to receive a fluid, such as a fluid configured to: achieve and / or enhance acoustic coupling between an integrated ultrasound array 850 and the target tissue; cool at least ultrasound array 850; change the flexibility of one or more portions of shaft assembly 130; and any combination of one or more of these.

[0188]

[0193] In some embodiments, treatment device 100 comprises a functional element 199 comprising a vacuum port (e.g., one or more vacuum ports), such as a vacuum port fluidly attached to a source of vacuum (e.g., as provided by a functional element 299 of console 200), the vacuum port comprising one or more vacuum ports positioned proximate ultrasound array 850 and configured to prevent ultrasound array 850 from moving (e.g., during imaging and / or ablation); keep one or more portions of treatment device 100 in contact with tissue; or both. In some embodiments, RMA 300 is configured to control the vacuum port, such as control used in a robotic manipulation of treatment device 100 by RMA 300.

[0189]

[0194] In some embodiments, treatment device 100 comprises a functional element 199 configured as an identifying component (e.g., an RFID or other identifying component), such as when console 200 and / or another component of system 10 is configured to receive treatment device 100 information and / or other information from the identifying component. The information received from the identifying component can comprise diagnostic information, calibration information, and / or manufacturing information of treatment device 100. The information received from the identifying component can be used by console 200 and / or another component of system 10 to confirm treatment device 100 is properly indicated, properly configured, and / or otherwise ready for use.

[0190]

[0195] In some embodiments, treatment device 100, RMA 300, and / or another component of system 10, is configured to reduce a “gripping” force applied to treatment device 100 by tissue when a distal portion of treatment device 100 is positioned in a body conduit or other internal location of a patient, for example when positioned in the urethra of a patient for a time period (e.g., a time period of at least 1 second, 5 seconds, and / or 30 seconds). In some embodiments, a gripping force presents or increases during treatment (e.g., due to tissue swelling that can occur during treatment). In some embodiments, treatment device 100 is configured to deliver one or more ultrasonic pulses to reduce a gripping force. Alternatively or additionally, treatment device 100, ultrasound assembly 800, RMA 300, and / or another component of system 10 is configured to cause one or more portions of that device to vibrate, such as to reduce a gripping force. In some embodiments, treatment device 100 and / or ultrasound assembly 800 includes a functional element 199 and / or 899, respectively, comprising a vibrating element such as a vibrating transducer configured to reduce a gripping force and / or to reduce forces (e.g., frictional forces) encountered while translating (e.g., advancing) the distal portion of the device through the urethra or other body conduit. Alternatively or additionally, treatment device 100 and / or ultrasound assembly 800 can include a functional element 199 and / or 899, respectively, comprising a lubricious and / or other coating configured to reduce a gripping force and / or to reduce forces encountered while translating (e.g., advancing) the distal portion of the device through the urethra or other body conduit. For example, the coating can comprise a polytetrafluoroethylene (PTFE) coating and / or other friction-reducing coating.

[0191]

[0196] In some embodiments, treatment device 100, ultrasound assembly 800, and / or STTT 920 are configured to deliver energy (e.g., ultrasound energy) at a high energy density to treat (e.g., ablate) tissue, such as an energy density of at least 100W / cm2. For example, the energy-delivering device can be configured to deliver at least 100W / cm2delivered to treat prostate tissue in a patient with BPH while the device is positioned within a urethra of the patient. The energy-delivering device of system 10 can be configured to deliver at least 100W / cm2delivered to treat tumor tissue and / or other tissue.

[0192]

[0197] Console 200 can comprise one or more consoles configured to operably attach to treatment device 100, ultrasound assembly 800, RMA 300, STTT 920, and / or one or more other components of system 10. In some embodiments, console 200 includes at least a portion of processing unit 50, at least a portion of user interface 60, and / or at least a portion of communication module 70, such as when console 200 comprises processing unit 205, user interface 206, and / or communication module 207, respectively, each shown.

[0193]

[0198] Console 200 can operably connect to treatment device 100, ultrasound assembly 800, RMA 300, STTT 920, and / or another component of system 10 via a wired and / or a wireless connection, such as via a connection provided between communication module 107 of treatment device 100 and communication module 207 of console 200. Console 200 can be configured to receive data, such as data 85 (e.g., to “upload” data 85) from treatment device 100, from user interface 206, from communication module 207, from RMA 300, from STTT 920, and / or from another component of system 10. In some embodiments, console 200 is configured to adjust one or more parameters of the operation of treatment device 100 and / or RMA 300, for example, based on the analysis of data 85. In some embodiments, data 85 comprises data that is specific to and / or otherwise used to identify each treatment device 100, RMA 300, and / or other components of system 10, such as identification data selected from the group consisting of serial number data; model number data; date of manufacture data; usage data; fault data; battery status data; and combinations of these. In some embodiments, console 200 is configured to upload data selected from the group consisting of patient data; procedural data; access device data; clinician data; environmental data; temporal data; and combinations thereof. In some embodiments, functional element 299 of console 200 comprises a data reader, such as a barcode reader, RFID reader, or other reader configured to read and / or otherwise receive data related to a component of system 10. Treatment device 100, ultrasound assembly 800, RMA 300, STTT 920, console 200, and / or another component of system 10 can each comprise a data source, such as a barcode, RFID, or other data source configured to be read by and / or otherwise transfer identification or other data to console 200 (e.g., via a functional element 299 comprising a data reader).

[0194]

[0199] Console 200 can comprise one or more consoles, such as one or more similar and / or different consoles 200.

[0195]

[0200] Console 200 can comprise ultrasound module 250 shown, which can comprise one or more modules (e.g., electronic modules) configured to: provide drive signals to ultrasound array 850 of ultrasound assembly 800; receive ultrasound signals (e.g., from recorded ultrasound reflections) from ultrasound array 850 of ultrasound assembly 800; or both.

[0196]

[0201] In some embodiments, ultrasound module 250 comprises a dual -frequency signal generator. For example, ultrasound module 250 can be configured to produce a first drive signal at a first frequency for delivering ultrasound to tissue that is located no more than a distance DI from ultrasound array 850, and to produce a second drive signal at a second frequency for delivering ultrasound to tissue that is located at least a distance D2 from ultrasound array 850, such as when D2 is the same or greater than DI and the first frequency is higher than the second frequency. In some embodiments, DI comprises a distance of 25mm or less, and the first frequency comprises a frequency of at least 4.5MHz and / or no more than 5.5MHz, such as a frequency of approximately 5.0MHz. Additionally, or alternatively, D2 can comprise a distance of 25mm or more, and the second frequency comprises a frequency of less than 3.5MHz and / or at least 2.5MHz, such as a frequency of approximately 3.0MHz. In these embodiments, DI can comprise a distance of at least 0.001mm and D2 can comprise a distance of no more than 50mm. In some embodiments, RMA 300 is configured to automatically position array 850 based on a particular drive frequency being used. Alternatively or additionally, system 10 (e.g., console 200) can be configured to automatically adjust a drive frequency based on a repositioning of an array 850 performed by RMA 300.

[0197]

[0202] Ultrasound module 250 can comprise a tuned circuit that operates at one or more frequencies of at least 1MHz, and / or at one or more frequencies of no more than 10MHz. Ultrasound module 250 can comprise two electronically switchable tuned circuits configured to provide operation at multiple different frequencies. Ultrasound module 250 can comprise relays and / or other switching components configured to switch between components of the two electronically switchable tuned circuits. One or more components of a first tuned circuit of the two electronically switchable tuned circuits can be shared by a second tuned circuit of the two electronically switchable tuned circuits. Ultrasound module 250 can be configured to operate a first set of one or more transducers 855 of ultrasound array 850 at a first frequency and to simultaneously operate a second set of one or more transducers 855 of ultrasound array 850 at a second frequency that is different than the first frequency.

[0198]

[0203] System 10 (e.g., via ultrasound assembly 800 or otherwise) can be configured to deliver high intensity focused ultrasound (HIFU) energy and / or other ultrasound energy to tissue, such as to target tissue to be ablated, stimulated, and / or otherwise treated by the delivery of the ultrasound energy. In some embodiments, treatment device 100 (e.g., a treatment device comprising ultrasound assembly 800) and / or ultrasound assembly 800 are configured to deliver “dynamic HIFU” energy to tissue, where the focus point of the HIFU energy is dynamically adjustable by system 10. As used herein, a “HIFU beam” comprises a set of ultrasonic signals that are transmitted from ultrasound array 850 to a focal point (e.g., forming the HIFU beam). Furthermore, one or more HIFU beams can be “formed” (e.g., ultrasound array 850 can form a HIFU beam) and / or “delivered” (e.g., a HIFU beam can be delivered to target tissue) by ultrasound array 850. “Forming” and “delivering” a HIFU beam are used interchangeably herein. The ultrasonic signals of the HIFU beam comprise a wavelength X.

[0199]

[0204] Ultrasound module 250 can comprise one or more HIFU drive circuitry components, HIFU driver 255 shown, which can comprise one or more transmit channels (e.g., driver channels configured to drive a transducer 855 to transmit ultrasound energy). In some embodiments, HIFU driver 255 is configured to deliver other forms of ultrasound energy, such as focused ultrasound energy configured to perform a histotripsy procedure, as described herein. HIFU driver 255 can comprise M transmit channels, and ultrasound array 850 can comprise N transducers 855. In some embodiments, M is equal to or greater than N (e.g., HIFU driver 255 includes at least one dedicated driver for each transducer 855 of ultrasound array 850). HIFU driver 255 can be configured to independently control the phase, amplitude, and / or both phase and amplitude of each transmit channel. Each channel of HIFU driver 255 can be controlled by processing unit 50 (e.g., computer controlled, such as when processing unit 50 comprises a microcontroller and / or an FPGA). Each channel of HIFU driver 255 can comprise a low latency control loop, for example a control loop comprising a minimal delay between a change in a parameter of the transmitted signal (e.g., a manual change initiated by an operator and / or an automatic change initiated by processing unit 50, such as via algorithm 55), and the change in the signal transmitted by the associated transducer 855. For example, a low latency control loop can comprise a delay of between 0ms and 100ms, for example approximately 5ms. Processing unit 50 can be configured to change (e.g., to dynamically change, such as while ultrasound energy is being delivered by ultrasound array 850) the focusing parameters of the HIFU beam being delivered, such as to dynamically focus (or refocus) the HIFU beam. Focusing parameters can include the focusing depth, the aperture size, the power output, and / or the focusing angle. The focusing point of the HIFU beam can be dynamically adjusted within the field of view of ultrasound array 850.

[0200]

[0205] In some embodiments, ultrasound array 850 can be configured to form two or more separate HIFU beams, such as two or more HIFU beams that are generated by overlapping sets of transducers 855 (e.g., two or more sets of transducers 855 that include one or more common elements) and / or non-overlapping sets of transducers 855. Each of the two or more HIFU beams can be independently and dynamically controlled by processing unit 50, as described herein. In some embodiments, two or more HIFU beams can be focused to a single focal point (e.g., such as to “combine” the two beams), and / or a single HIFU beam can be “split”, such as when a single HIFU beam is divided into two or more beams that are focused on separate targets.

[0201]

[0206] Ultrasound module 250 can comprise one or more ultrasound imaging drive circuitry components and / or signal recording components, imaging driver 256 shown. Imaging driver 256 can comprise T transmit channels (e.g., driver channels configured to drive a transducer 855 to transmit ultrasound energy), and / or imaging driver 256 can comprise R receive channels (e.g., channels configured to record reflected ultrasound signals that are sensed by a transducer 855). In some embodiments, the T transmit channels comprise one or more transmit channels, and the R receive channels comprise one or more receive channels, such as when T is equal to R (T=R) which are both less than or equal to N (the number of transducers 855 of ultrasound array 850). For example, when N is greater than T and / or R, imaging driver 256 can comprise one or more switching circuits that are configured to multiplex T transmit channels and / or R receive channels to N transducers 855 (e.g., low loss MEMS switches). In some embodiments, HIFU driver 255 and imaging driver 256 comprise one or more of the same components, for example when a transmit channel of HIFU driver 255 is configured to transmit ultrasound energy for both HIFU energy delivery and to image tissue (e.g., to deliver HIFU energy during a HIFU treatment portion, and to deliver imaging energy during an imaging portion of a treatment procedure, as described herein). In some embodiments, HIFU driver 255 comprises imaging driver 256, for example when ultrasound module 250 does not comprise separate transmit channels for delivering HIFU and imaging energy, and / or when HIFU driver 255 also comprises one or more receive channels.

[0202]

[0207] In some embodiments, ultrasound module 250, functional element 299, and / or another component of console 200, is configured to deliver light (e.g., console 200 further comprises a laser configured to deliver pulsed light), such as when treatment device 100 and / or another component of system 10 comprises a lens or other light-delivering element configured to produce photoacoustic image data based on pulsed light provided by console 200, as described herein.

[0203]

[0208] In some embodiments, system 10 includes one or more servers, server 80 shown, where each server 80 can be configured to provide data storage and / or data processing, such as data processing for the providers of system 10 (e.g., the manufacturer and / or distributor of system 10) and / or the users of system 10. As used herein, data processing can refer to: the receiving of data; the filtering, sorting, analysis, and / or other processing of data; the transmission of data (e.g., transmitting the results of data processing); and / or the storage of data, such as data received from multiple consoles 200, multiple treatment devices 100, multiple ultrasound assemblies 800, multiple RMA 300s, multiple STTT 920s, and / or multiple other components of system 10 located at various clinical sites. Server 80 can comprise one or more processing units 50. Additionally, or alternatively, server 80 can include one or more data storage units for storing data collected by system 10, data 85 shown. In some embodiments, server 80 is configured to process data from various users of system 10, for example when the provider of system 10 maintains one or more servers 80 configured to process data for each (and / or a subset) of the users of system 10 (e.g., each of the patients and / or clinicians of system 10). Server 80 can comprise an “off-site” server (e.g., remotely located from the users of system 10), such as a server owned, maintained, and / or otherwise provided by the provider of system 10. Alternatively, or additionally, server 80 can comprise a cloud-based server.

[0204]

[0209] In some embodiments, data 85 includes data recorded during a medical procedure, for example data related to one or more ultrasound energy delivery parameters, one or more robotic manipulation parameters, and / or one or more patient parameter (e.g., location of tissue receiving energy delivery and / or one or more patient physiologic parameters present when energy was delivered).

[0205]

[0210] In some embodiments, server 80 is configured to communicate with one or more treatment devices 100, such as communication provided via network 75 between communication module 107 and server 80, and / or between communication module 107 and communication module 207 of console 200, where console 200 is configured to communicate with one or more treatment devices 100, and server 80 is configured to communicate with one or more consoles 200 (e.g., to communicate via network 75). In some embodiments, server 80 is configured to collect data 85, for example data 85 comprising usage information (e.g., treatment device 100, ultrasound assembly 800, and / or RMA 300 usage information). In some embodiments, server 80 is configured to collect data 85 comprising robotic manipulations performed by RMA 300.

[0206]

[0211] As described herein, one or more components of system 10 can comprise all or a portion of processing unit 50, such as a processing unit 50 comprising a processor 51 and memory 52 coupled to the processor 51, where memory 52 stores instructions 53 for processor 51 to perform algorithm 55. In some embodiments, algorithm 55 comprises an Al algorithm, such as when the Al algorithm is trained based on usage data collected by server 80.

[0207]

[0212] System 10 can include one or more assemblies that are configured to alert a user of system 10, alert assembly 40 shown. One or more devices or other components of system 10 can comprise all or a portion of an alert assembly 40, such as when all or a portion of an alert assembly 40 is integral to: treatment device 100, console 200, ultrasound assembly 800, RMA 300, STTT 920, and / or another component of system 10. Alert assembly 40 can include one or more alert elements, alert element 49 shown, that provide a visible, audible, tactile, and / or other signal to a user. In some embodiments, alert assembly 40 is configured to provide an alert, via alert element 49, indicating a warning or other alert condition to a user (e.g. an undesired or other event or condition has occurred and / or is present). All or a portion of one or more alert assemblies 40 can be integrated into one, two, or more of the various components of system 10, such as when integrated into treatment device 100, RMA 300, and / or other component of system 10.

[0208]

[0213] In some embodiments, alert element 49 of alert assembly 40 comprises two or more alert elements. For example, alert assembly 40 can comprise a first alert element 49a and a second alert element 49b. The first and second alert elements 49 can be configured to be independently activated (e.g., to independently alert the user of different alert conditions of system 10). In some embodiments, alert assembly 40 comprises a first alert element 49a comprising a tactile alert element (e.g., a haptic transducer), and a second alert element 49b comprising a non-tactile alert element, such as an indicator light, a speaker or buzzer, and / or other output device that alerts the user to a warning and / or other alert condition.

[0209]

[0214] In some embodiments, system 10 is configured to allow a user (e.g., a clinician) to set one or more alert thresholds for a set of one or more parameters that are monitored by the system (e.g., one or more parameters that are monitored by treatment device 100, ultrasound assembly 800, console 200, and / or other system 10 component). In these embodiments, when a threshold of a monitored parameter is exceeded, alert assembly 40 can be configured to alert one or more users of system 10, for example the clinician using treatment device 100 and / or ultrasound assembly 800. In some embodiments, a threshold represents a maximum force to be applied to tissue, such as a maximum force to be applied to tissue by treatment device 100, ultrasound assembly 800, and / or STTT 920 while the particular component is being manipulated by RMA 300.

[0210]

[0215] As described herein, one or more components of system 10 can include at least a portion of a processing unit 50, for example processing units 105 and / or 205 of treatment device 100 and console 200, respectively, each comprising at least a portion of a processing unit 50. Various processing units of system 10 can be referred to singly or collectively herein, as processing unit 50. Processing unit 50, for example by performing algorithm 55 via processor 51, can be configured to detect a target location and / or a non-target location to be imaged, treated (e.g., ablated), or both.

[0211]

[0216] In some embodiments, system 10 is configured to differentiate between a first tissue type and a second tissue type. For example, image data ID collected using ultrasound assembly 800 can be used by processing unit 50 to differentiate the tissue type. In some embodiments, processing unit 50 is configured to differentiate between healthy tissue and diseased tissue, between ablated tissue and non-ablated tissue, and / or to make another differentiation in tissue.

[0212]

[0217] In some embodiments, one or more components of system 10 are configured to be calibrated. For example, one or more components of treatment device 100, ultrasound assembly 800, and / or RMA 300 can be configured to be calibrated.

[0213]

[0218] In some embodiments, system 10 includes one or more pharmaceutical and / or other agents, agent 30 shown, such as one or more agents that may be administered prior to, during, and / or after use of treatment device 100, ultrasound assembly 800, and / or RMA 300. In some embodiments, agent 30 comprises one, two, or more tissue markers, such as one, two, or more tissue markers selected from the group consisting of: photoacoustic tags; ultrasonically-reflective tissue markers; visualizable tissue markers; magnetic tissue markers; and combinations of these. In some embodiments, RMA 300 robotically manipulates treatment device 100 and / or another component of system 10 via image data ID including the location of the agent 30 comprising one, two, or more tissue markers.

[0214]

[0219] In some embodiments, system 10 comprises one or more elements configured to deliver agent 30, delivery element 35 shown. Delivery element 35 can comprise one or more needles, fluid jets, iontophoretic delivery elements, and / or other delivery elements configured to deliver a fluid or other flowable material. Treatment device 100, ultrasound assembly 800, RMA 300, and / or STTT 920 can each comprise one or more delivery elements 35. In some embodiments, delivery element 35 is configured to be robotically manipulated by RMA 300.

[0215]

[0220] In some embodiments, system 10 includes one or more additional imaging devices, second imaging device 960 shown. Second imaging device 960 can comprise one, two, or more imaging devices selected from the group consisting of: an ultrasound imaging device; a fluoroscope and / or other X-ray imaging device; a magnetic resonance imaging (MRI) device; a CT Scanner; an optical coherence tomography (OCT) imaging device; a transesophageal echo imaging device; a transrectal imaging device; a catheter-based imaging device; a cystoscope; a photoacoustic imaging device; an impedance-based imaging device; and combinations of these. In some embodiments, system 10 is configured to produce a first set of image data ID using ultrasound assembly 800, and to produce at least a second set of image data ID using second imaging device 960. In these embodiments, system 10 can be further configured to compare and / or combine the first set of image data ID with the second set of image data ID.

[0216]

[0221] In some embodiments, system 10 includes one or more accessory devices, accessory device 700 shown. Accessory device 700 can comprise a positioning device configured to establish one or more reference points that can be used by treatment device 100 for creating images, delivering ablation energy, or both. Accessory device 700 can comprise a balloon catheter, such as a balloon catheter that is configured to dilate the urethral passage and / or other passage through which treatment device 100 is inserted. In some embodiments, accessory device 700 comprises a first accessory device 710, a second accessory device 720, or both.

[0217]

[0222] As described herein, system 10 can comprise one or more functional elements, such as functional elements 99, 199, 299, 399, 499, 599, 699, and / or 899 shown. Each functional element can comprise one or more sensors, one or more transducers, and / or one or more other functional elements. RMA 300 can be configured to robotically manipulate one or more functional elements, such as to position a functional element relative to tissue and / or a component of system 10, such that the functional element can perform a desired function. A functional element (e.g., functional element 99, 199, 399, 499, and / or 599) can comprise a tissue manipulating element (e.g., a balloon). A functional element (e.g., a functional element 99, 199, 399, 499, 599, 699) can comprise one or more optical fibers configured to provide treatment device 100 and / or other system 10 component geometry data and / or treatment device 100 and / or other system 10 component orientation data. The functional element comprising the one or more optical fibers can be configured to provide: 3D dimensional coordinate data; roll data; pitch data; and / or yaw data (e.g., of treatment device 100 and / or another component of system 10).

[0218]

[0223] In some embodiments, system 10 (e.g. via algorithm 55) is configured to perform a “system diagnostic procedure”. For example, system 10 can be configured to assess the functionality of one or more components of RMA 300. When one or more malfunctioning components of RMA 300 are identified (e.g., confirmed via a system diagnostic procedure), system 10 can: enter an alert state; disable function of RMA 300 or another system 10 component; and / or perform another alert function and / or compensation function. System 10 can be configured to perform various system diagnostic procedures.

[0219]

[0224] In some embodiments, system 10 is configured to determine an “angle of orientation” of ultrasound array 850 (e.g., an angle of orientation of all or a portion of ultrasound array 850), such as an angle of orientation of an ultrasound array 850 relative to a portion of ultrasound assembly 800. Ultrasound assembly 800 can comprise an outer wall (e.g., an outer wall of shaft assembly 130 when assembly 800 is integral to device 100), and the angle of orientation can be determined based on a reflection of ultrasound received from the outer wall (e.g., sent and received by one or more transducers 855). In some embodiments, system 10 is configured to determine an angle of orientation using, at least, photoacoustic data, such as photoacoustic data produced as described herein. System 10 can be configured to produce a two-dimensional (2D) and / or three-dimensional (3D) image, and system 10 can enhance (e.g., correct, adjust, and / or otherwise enhance) a 2D or 3D image based on the determined angle of orientation.

[0220]

[0225] System 10, treatment device 100, and / or ultrasound assembly 800 can be constructed and arranged such that at least a distal portion of ultrasound assembly 800 can be inserted into the patient by an operator (e.g., a clinician), by RMA 300, or both, and ultrasound array 850 can be positioned a desired distance from target tissue when the insertion procedure is completed. System 10 can be configured to produce one or more images of tissue of the patient prior to completion of the insertion procedure, and ultrasound array 850 can be positioned at the desired distance based on the one or more images (e.g., images used to guide the insertion and / or stop advancement of ultrasound assembly 800).

[0221]

[0226] System 10 and ultrasound assembly 800 can be configured to produce one or more multi-dimensional images (e.g., 2D and / or 3D images) of tissue, and each multidimensional image can comprise at least a partial circumferential image of tissue. Each partial circumferential image can represent a sector of tissue of at least 180°, such as images representing up to 360° (e.g., greater than 350°). In some embodiments, a manual movement (e.g., a rotation, a translation, or both) of ultrasound assembly 800 is performed (e.g., during image capture) in order to create multi-dimensional images of tissue. The manual movement can be performed by an operator (e.g., a clinician). In some embodiments, RMA 300 is used to rotate and / or translate ultrasound assembly 800 to create multi-dimensional images. In some embodiments, a combination of a movement of ultrasound assembly 800 by an operator, and movement of ultrasound assembly 800 by RMA 300, is used to create one or more multi-dimensional images. System 10 can be configured to analyze (e.g., via algorithm 55) one or more multi-dimensional images, such as to produce tissue information (e.g., information of a 2D or 3D portion of tissue). The tissue information can comprise tissue information identified using one or more tissue markers, such as one or more ultrasonically- reflective tissue markers, one or more photoacoustic tags, or both. System 10 can be configured (e.g., via algorithm 55) to perform diagnostics (e.g., clinical diagnostics) and / or therapy planning based on the one or more multi-dimensional images produced (e.g., based on an analysis of the one or more multi-dimensional images). In some embodiments, the one or more multi-dimensional images comprise images of the patient’s prostate (e.g., the majority of the patient’s prostate), such as when the multi-dimensional images are based on ultrasound reflections received by ultrasound assembly 800 while ultrasound array 850 is positioned (e.g., rotated and / or translated) within the prostatic urethra. In some embodiments, the one or more multi-dimensional images comprise images of a uterus of a patient, such as when the multi-dimensional images are based on ultrasound reflections received by ultrasound assembly 800 while ultrasound array 850 is positioned (e.g., rotated and / or translated) within a uterus. Ultrasound assembly 800 (e.g., at least a distal portion of assembly 800 configured for insertion into a patient, and / or a distal portion of a treatment device 100 comprising assembly 800) can comprise one or more flexible portions (e.g., flexible segments) such that ultrasound assembly 800 can be safely and effectively translated through a conduit of the patient (e.g., such that reduced forces are encountered when translated through a conduit, such as when translated within the prostatic urethra). In some embodiments, ultrasound assembly 800 (e.g., or a treatment device 100 comprising assembly 800) comprises a rigid segment (e.g., a rigid segment within which ultrasound array 850 is positioned), such as a rigid segment that has a flexible segment on each end of the rigid segment. Ultrasound assembly 800 can comprise one or more components (e.g. one or more components of shaft assembly 130 when treatment device 100 comprises assembly 800) of sufficient torsional strength to allow rotation (e.g., smooth rotation) within the patient conduit, such as to effectively create a multi-dimensional image.

[0222]

[0227] Ultrasound assembly 800 can comprise multiple arrays, as described herein, such as an ultrasound array 850 comprising a first array 850a and a second array 850b. A functional element 899 can comprise a mechanical assembly configured to attach first array 850a to second array 850b. The functional element 899 comprising a mechanical assembly can be configured to transition between a first state in which the first array 850a and the second array 850b are flexibly connected (e.g. to allow safe and effective translation of ultrasound array 850 in a conduit of the patient), and a second state in which the first array 850a and the second array 850b are rigidly connected (e.g., a rigid condition in which one or more portions of array 850 are at a known angle of orientation relative to each other or another portion of ultrasound assembly 800). In these embodiments, the functional element 899 comprising a mechanical assembly can comprise a shape memory component, a mechanical linkage, or both.

[0223]

[0228] System 10 can be configured to: automatically identify (e.g., via algorithm 55) one or more tissue landmarks; and / or allow an operator to manually identify one or more tissue landmarks. The landmark identification can be used to: robotically manipulate one or more system 10 components via RMA 300; automatically position and / or reposition ultrasound array 850 via RMA 300; and / or allow an operator to manually position and / or reposition ultrasound array 850. A tissue landmark can comprise the verumontanum (e.g., when treating a prostate). System 10 (e.g., via algorithm 55, such as an Al algorithm) can be configured to continuously and / or intermittently image tissue during a treatment performed using ultrasound assembly 800, such as to track the progress of the treatment. System 10 can be configured to continuously or at least repeatedly confirm proper positioning of ultrasound assembly 800 and / or another system 10 component during ablation and / or other tissue treatment, such as by monitoring changes in target tissue being treated. System 10 can be configured to provide treatment planning, and / or identify fiducial markers and / or safe zones.

[0224]

[0229] As described herein, ultrasound assembly 800 (e.g., a treatment device 100 comprising at least a portion of ultrasound assembly 800) can comprise a distal portion configured for insertion through the urethra, such as when the system is configured to image tissue of the bladder and / or locations within the bladder. For example, system 10 can be configured to provide images of and / or treatment of the bladder wall, and / or to diagnose and / or treat other locations within and / or otherwise proximate the bladder. In some embodiments, RMA 300 is configured to robotically manipulate ultrasound assembly 800 into and / or within a bladder. In some embodiments, second imaging device 960 comprises a transrectal ultrasound imaging device used in a bladder diagnostic and / or treatment procedure. Alternatively, system 10 can be configured to diagnose and / or treat a patient’s bladder without the use of transrectal ultrasound imaging.

[0225]

[0230] System 10 (e.g. using ultrasound assembly 800) can be configured to perform a biopsy procedure on the patient. For example, a functional element 99 can comprise a biopsy collection device and system 10 can be configured to collect the biopsy via image data ID produced by ultrasound assembly 800. System 10 can be configured to perform a biopsy in various configurations.

[0231] System 10 can be further configured to “optimize” (e.g., improve for subsequent manual and / or automated analysis) a set of one or more images, such as optimization via use of harmonic imaging in collection of image data ID. As described herein, ultrasound assembly 800 (e.g., a treatment device 100 comprising assembly 800) can comprise a distal portion that is configured to be inserted through one or more conduits (e.g., the prostatic urethra and / or one or more other body lumens) of the patient. System 10 can be configured to produce image data ID such as to use the image data ID to create a set of one or more images during and / or after insertion through the body conduit, and to optimize this set of images.

[0226]

[0232] System 10 can be configured (e.g., via ultrasound assembly 800 and / or algorithm 55) to determine one or more characteristics of tissue. System 10 can be configured to determine the tissue characteristics based on a measurement of attenuation of ultrasound delivered by ultrasound array 850. System 10 can be configured to use the determined tissue characteristics to: predict the efficacy of an ablation and / or other tissue treatment using ultrasound assembly 800; and / or to determine one or more ultrasound delivery parameters used by assembly 800 to perform an ablation and / or other tissue treatment.

[0227]

[0233] As described herein, treatment device 100, ultrasound assembly 800, STTT 920, and / or other energy-delivering component of system 10 can be configured to deliver energy (e.g., ultrasound) to treat a patient (e.g., to ablate and / or otherwise treat target tissue of a patient), and system 10 can be configured (e.g. via algorithm 55) to monitor the progress of the treatment. System 10 can be configured to perform the monitoring of the progress of the treatment by simulating heat propagation that results from the delivery of the energy, such as a simulation of heat propagation based on: energy delivery parameters; ultrasound delivery parameters; parameters of treatment device 100, ultrasound assembly 800, and / or STTT 920; and / or parameters of the tissue and other material proximate a system 10 component (e.g., proximate ultrasound array 850) during the delivery of the ablative energy. System 10 can be configured to simulate the heat propagation based on: measurement of tissue attenuation using image data ID produced by system 10. System 10 can be configured to measure the tissue attenuation via an analysis of signal -to-noise ratio versus depth. Analysis by system 10 can comprise an analysis of data (e.g., image data ID) taken before and during the delivery of the energy (e.g., ultrasound energy) of the treatment. System 10 can be further configured (e.g. via algorithm 55) to provide a “confidence range” associated with the monitoring of the progress of the treatment. In the monitoring of the treatment, system 10 can be configured to account for: changes in absorption, perfusion, and / or other tissue properties that can occur during the treatment. System 10 can be configured to monitor one or more parameters of ultrasound transducers 855, and system 10 can be configured to perform the monitoring of the progress of the treatment based on the monitored ultrasound transducer parameters. System 10 can be configured to collect image data ID, such as when system 10 is further configured to perform the monitoring of the progress of the treatment based on the collected image data ID. System 10 can use local image intensity statistics technique to evaluate changes in tissue over time, such as when the collected image data comprises images taken prior to the treatment, during the treatment, and after the treatment (e.g., images collected with the same field-of-view). The local image intensity statistics technique used by system 10 can include extracting local image statistics, such as local image statistics comprising: local means; local standard deviations; local extrema; local kurtosis; local skewness; and / or local higher-order standardization moments. The image intensity statistics technique used by system 10 can include: principal component analysis; singular value decomposition; and / or other feature extraction and / or selection techniques. The monitoring of the treatment performed by system 10 can comprise: creating a first set of one or more images prior to the treatment (e.g., based on image data ID recorded prior to the treatment); creating a second set of one or more images after the treatment (e.g., based on image data ID recorded after the treatment); and combining and / or comparing the first set of one or more images with the second set of one or more images. In some embodiments, image data ID recorded during the treatment is used. System 10 can be configured to produce a visual output (e.g. provided by user interface 106, user interface 206, and / or other user interface 60) in which tissue properties representing the effects of an ablation or other treatment are highlighted, color- coded, and / or otherwise graphically differentiated.

[0228]

[0234] As described herein, system 10 can be configured to perform various treatment procedures comprising delivery of ultrasound and / or other form of energy. In some embodiments, system 10 can be further configured to produce a “treatment log” representing associated treatment parameters used, and / or treatment results achieved. The treatment log can comprise a comparison of tissue intended to be treated and actual tissue treated. System 10 can be configured to produce the treatment log (e.g., at least a portion of the treatment log) prior to the completion of the treatment procedure. The treatment log produced by system 10 can comprise an analysis of one or more treatment parameters (e.g., one or more treatment parameters measured and / or otherwise determined prior to, during, and / or after a treatment performed by system 10), such as: pressure zones and / or other pressure measurements (e.g., intraurethral pressure measurements performed in a BPH treatment procedure); ablation volumes; and / or ablation volumes relative to total volumes.

[0229]

[0235] System 10 can be configured to gather various forms of image data ID, and produce an anatomical model, model AM, comprising one or more models (e.g., maps) of one or more portions of the patient’s anatomy. The model AM produced by system 10 can be created based on image data produced by system 10, such as image data produced using ultrasound assembly 800, second imaging device 960, and / or another imaging device of system 10. In some embodiments, model AM is produced by algorithm 55 of system 10 (e.g., an Al algorithm or other algorithm). Model AM can comprise a two-dimensional (2D) portion, a three-dimensional (3D) portion, or both.

[0230]

[0236] In some embodiments, system 10 can be configured to produce image data ID via ultrasound assembly 800 (e.g., to create model AM or otherwise) based on properties of tissue and / or other materials (e.g., materials of a balloon, fluid within a balloon, and / or other treatment device 100 component) that are located in the acoustic pathway between ultrasound assembly 800 and objects (e.g., tissue) being imaged. For example, quality of image data ID can be improved via a compensation for impact of certain materials being present in the acoustic pathway.

[0231]

[0237] In some embodiments, system 10 is configured to include temperature information in model AM, such as current or past temperature information related to an energy delivery into tissue (e.g., to ablate the tissue), or prognostic temperature information related to a potential future energy delivery into tissue.

[0232]

[0238] System 10 can be configured to: collect a first set of image data ID, and perform a first tissue treatment procedure to treat a first volume of target tissue. System 10 can be further configured to subsequently collect a second set of image data ID, and then perform a second tissue treatment procedure on a second volume of target tissue (e.g., where the second volume of target tissue includes at least a portion of the first volume of target tissue, or when all of the second volume of target tissue is different tissue than the first volume of target tissue). The first and / or second sets of image data ID can be produced using ultrasound assembly 800, second imaging device 960, and / or another imaging device. The second set of image data can include identification of un-treated tissue that was intended to be treated in the first tissue treatment procedure.

[0239] System 10 can comprise one or more energy delivery components configured to deliver energy to tissue to treat the tissue, such as treatment assembly 150 (e.g., a treatment assembly 150 comprising at least a portion of ultrasound assembly 800 and / or one or more other energy delivery elements), ultrasound assembly 800, STTT 920, and / or another component of system 10 configured to deliver energy to tissue. System 10 can be configured to change the current field of view of the energy delivery component delivering energy, such as a field of view change performed via one, two, or all of (1) an electronic focus adjustment of the energy delivery component; (2) translation and / or rotation of the energy delivery component within a surrounding shaft; and / or (3) translation and / or rotation of a shaft that surrounds the energy delivery component. A change in field of view using (1) can have a narrower range of the collective field of view than (2), and a change in field of view using (2) can have a narrower range of the collective field of view than (3). A change in field of view using (1) can have finer control during the adjustment than (2), and a change in field of view using (2) can have a finer (e.g., more precise) control during the adjustment than (3).

[0233]

[0240] Image data ID produced by ultrasound assembly 800, second imaging device 960, and / or another component of system 10 can comprise data related to blood flow of the patient, such as when ultrasound assembly 800 performs one or more doppler ultrasoundbased data collections. Collection of image data ID by ultrasound assembly 800 and / or another imaging device of system 10 can include collection of image data ID performed prior to, during, and / or after a manipulation (e.g., an automatic and / or manual manipulation) of the imaging device by RMA 300.

[0234]

[0241] As described herein, system 10 can comprise one or more devices for delivering energy to treat tissue. For example, treatment assembly 150 of treatment device 100, STTT 920, and / or another component of system 10, can be configured to deliver energy to tissue to ablate the tissue. In some embodiments, treatment assembly 150, STTT 920, and / or another component of system 10 comprises ultrasound assembly 800, and HIFU, other focused ultrasound (e.g., histotripsy-causing focused ultrasound), and / or other ultrasound energy is delivered to treat the tissue. Alternatively, or additionally, energy delivery by one or more of these components can comprise energy of one, two, or more forms selected from the group consisting of sound energy such as ultrasound energy; light energy such as laser light energy; thermal energy such as heat energy and / or cryogenic energy; electromagnetic energy such as radiofrequency energy, microwave energy, and / or electroporation energy; chemical energy; mechanical energy; and combinations of one, two, or more of these.

[0242] In some embodiments, shaft assembly 130 of treatment device 100 comprises one or more positioning elements, positioning element 131, that is configured to allow selective positioning of treatment assembly 150 (e.g., a treatment assembly 150 comprising ultrasound transducers 855 of an ultrasound array 850) relative to tissue. Positioning element 131 can comprise a balloon, expandable cage, unfurlable element, and / or other expandable (and / or contractable) element that can have its geometry changed (e.g., expand, contract, or both) to control (e.g., precisely control) the distance between treatment assembly 150 and a tissue surface (e.g., a tissue surface of a volume of target tissue to be ablated, stimulated, and / or otherwise treated). Geometry changes of positioning element 131 (e.g., as performed by RMA 300 or other system 10 component) can be performed automatically by system 10, manually by an operator of system 10, or both. In some embodiments, positioning element 131 comprises a balloon that is configured to receive a fluid (e.g., saline or other liquid). The received fluid can be used to perform a controlled expansion, and the fluid can be removed to perform a controlled contraction. In some embodiments, positioning element 131 comprises a balloon configured to receive a fluid, and the received fluid creates an acoustic pathway comprising a fluid pathway between ultrasound transducers 855 within treatment assembly 150 and the target tissue.

[0235]

[0243] As described herein, treatment device 100 can comprise one, two, or more devices configured to treat tissue, such as to ablate tissue, stimulate tissue, and / or otherwise treat tissue (e.g., target tissue). In some embodiments, treatment device 100 comprises one, two, or more devices selected from the group consisting of: elongate tool; catheter; probe; laparoscopic probe; surgical tool; minimally invasive surgical tool; hand-held tool; robotically-manipulatable tool; and combinations of these. Treatment device 100 can comprise an elongate tool with a shaft assembly 130 comprising an angled distal portion, such as a device in which a (central) axis of the distal portion of shaft assembly 130 is angularly offset from a (central) axis of the adjacent, more proximal portion of shaft assembly 130. One or more portions of ultrasound assembly 800 (e.g., one or more arrays 850) can be positioned within the distal portion of the shaft assembly 130. The angular offset can comprise an offset of at least 45 degrees, or at least 90 degrees. The angular offset can be configured to safely (e.g., atraumatically), and / or easily position one or more arrays 850 of the distal portion of shaft assembly 130 against a tissue surface, such as the wall of the uterus of a patient.

[0244] Treatment device 100 can comprise a device configured to be inserted through a patient access device, such as an access device selected from the group consisting of introducer; vascular introducer; laparoscopic port; endoscope; retractor; cervical expansion device; and combinations thereof. Alternatively, or additionally, treatment device 100 can be configured to be inserted through a natural orifice of the patient, and / or through a surgical incision made into the patient.

[0236]

[0245] As described herein, ultrasound assembly 800 can comprise one, two, or more ultrasound components, each comprising one or more ultrasound transducers 855.

[0237] Ultrasound transducers 855 can comprise one or more CMUTs, one or more piezo transducers, or both. Ultrasound assembly 800 can comprise one or more ultrasound arrays 850, and each array 850 comprises a ID array (as described herein), a 1.5D array (as described herein), or an array of different configuration.

[0238]

[0246] Ultrasound assembly 800 can comprise a gel block (e.g., a functional element 899 comprising a gel-based substrate) that is configured to be positioned between the assembly 800 and tissue, and / or between assembly 800 and RMA 300. In some embodiments, the gel block can be configured to be expanded and / or contracted, such as via RMA 300. In some embodiments, the gel block can comprise an umbrella geometry.

[0239]

[0247] Ultrasound assembly 800 can be configured to treat tissue (e.g., target tissue) via the delivery of HIFU or other ablative ultrasound energy. In some embodiments, system 10 (e.g., ultrasound assembly 800 via one or more algorithms 55) is configured to adjust the frequency of ultrasound energy (e.g., ablative ultrasound energy) delivered by ultrasound assembly 800 based on one or more of distance to the target tissue; tissue type of the target tissue; and / or characteristics of tissue between the ultrasound transducers and the target tissue. In some embodiments, system 10 (e.g., ultrasound assembly 800 via one or more algorithms 55) is configured to adjust the focus (e.g., adjust the field of view) of ultrasound energy delivery (e.g., ablative ultrasound energy delivery), such as to deliver the ultrasound energy to two different volumes of tissue (e.g., simultaneously or sequentially).

[0240]

[0248] System 10 (e.g., ultrasound assembly 800 via algorithm 55) can be configured to interleave between delivery of ultrasound energy for collecting the image data and delivery of ultrasound energy for treating the target tissue. System 10 (e.g., ultrasound assembly 800 via algorithm 55) can be configured to adjust the frequency of ultrasound energy delivered to produce image data ID. The frequency adjustment can be based on one or more of resolution and / or other image property of image data ID to be produced; distance to tissue to be imaged; tissue type of tissue to be imaged; and / or characteristics of tissue between the ultrasound transducers 855 and the tissue to be imaged. System 10 can be configured to adjust the frequency of the ultrasound energy delivered to produce the image data ID, such as when the frequency adjustment is based on one or more of: resolution and / or other image property of image data ID to be produced; distance to tissue to be imaged; tissue type of tissue to be imaged; and / or characteristics of tissue between the ultrasound transducers and the tissue to be imaged.

[0241]

[0249] System 10 (e.g., via algorithm 55) can be configured to dynamically adjust imaging time, treatment time, or both. Alternatively, or additionally, system 10 can be configured to dynamically adjust the focus of ultrasound energy for imaging, treatment, or both.

[0242]

[0250] Ultrasound assembly 800 can comprise one or more ultrasound arrays 850, where the field of view of each array can be adjusted, such as an adjustment performed by: adjusting an electronic focus of the ultrasound array 850; translating and / or rotating the ultrasound array 850; or both. RMA 300 can be configured to perform the translation and / or rotation of one or more ultrasound arrays 850. In some embodiments, shaft assembly 130 of treatment device 100 can comprise a shaft that surrounds a first ultrasound array 850a, and system 10 can be configured to translate and / or rotate the first ultrasound array 850a by: translating and / or rotating the shaft of treatment device 100; translating and / or rotating the first ultrasound array 850a within the shaft of treatment device 100; or both. The first ultrasound array 850a can be located in a segment of the shaft of treatment catheter 100, and RMA 300 can be configured to twist (e.g., twist at least 45 degrees, or at least 90 degrees) the segment of the shaft to change the field of view of the first ultrasound array 850a.

[0243]

[0251] In some embodiments, system 10 can be configured to perform an electronic adjustment (e.g., an electronic focusing) to adjust the field of view of an ultrasound array 850, such as to adjust the field of view in a first plane. In these embodiments, system 10 (e.g., via RMA 300) can be further configured to translate and / or rotate the ultrasound array 850 to adjust the field of view in a second plane (e.g., a second plane perpendicular to the first plane), such as to treat target tissue comprising tissue of the tongue, tonsil, and / or soft palate, or tissue of a fibroid.

[0244]

[0252] In some embodiments, system 10 further comprises a hinge, ball joint, and / or other articulation element, articulation element 95 shown, that can be attached to at least one ultrasound array 850 and / or another component of system 10. Rotation (e.g., by RMA 300) of one or more ultrasound arrays 850 attached to the articulation element 95 can be used to change the field of view of the one or more ultrasound arrays 850, such as to treat multiple different tissue volumes of target tissue (e.g., to treat multiple fibroids and / or multiple different tissue volumes of the tongue, a tonsil, and / or soft palate). In some embodiments, articulation element 95 comprises a lockable articulation element (e.g., can be locked by an operator and / or RMA 300). In some embodiments, articulation element 95 comprises at least a first articulation element 95a and a second articulation element 95b. In these embodiments, first articulation element 95a can comprise a lockable articulation element that is configured to allow rotation of an ultrasound array 850 along a tissue surface (e.g., the wall of the uterus or a surface of a tongue), after which it is locked. Second articulation element 95b can be used to further rotate the ultrasound array 850, such as to change the field of view.

[0245]

[0253] As described herein, ultrasound assembly 800, STTT 920, and / or another energydelivering component of system 10 can be used to treat various types of tissue, such as: fibroid tissue (e.g., uterine fibroid tissue); base of tongue tissue, tonsil tissue, and / or soft palate tissue (e.g., ablated in a sleep-apnea reducing procedure), and / or other tissue types. Target tissue to be treated can comprise multiple volumes of tissue, such as multiple adjacent volumes of tissue, and / or multiple non-adjacent volumes of tissue. In some embodiments, multiple volumes of tissue are treated via one or more ultrasound arrays 850 via a procedure in which one volume of target tissue is treated through an ultrasound energy delivery (e.g., delivery of HIFU and / or other focused ultrasound energy delivery), the focus of energy is then adjusted (e.g., to change the field of view to include the second volume of tissue), and a second volume of target tissue is treated. In these embodiments, the two volumes of tissue can be treated without translating, rotating, and / or otherwise moving the ultrasound array 850 (e.g., field of view changed via electronic means only). Such avoidance of moving the array 850 can increase safety, reduce procedure time, and / or provide other benefits. In some embodiments, changing the electronic focus of one, two, or more arrays 850, combined with translating, rotating, and / or otherwise moving the ultrasound array 850, is used to treat one, two, or more volumes of target tissue.

[0246]

[0254] An electronic and / or movement-based adjustment of the field of view of one, two, or more ultrasound arrays 850 can be performed to compensate for patient movement, such as to keep the field of view of an array 850 directed toward a particular volume of tissue, as that tissue volumes moves (e.g., during respiration or other cause of tissue movement). In some embodiments, ultrasound array 850 comprises a 1.5D, a 1.75D array, and / or a 2D array that is configured to compensate for patient movement via electronic adjustment of its focus only, such as to change the field of view without movement of the array 850.

[0247]

[0255] As described herein, ultrasound assembly 800 can comprise, one, two, or more ultrasound arrays 850, and each array can comprise one, two, or more ultrasound transducers 855. System 10 (e.g., ultrasound assembly 800) can further comprise an electronic switch (e.g., a functional element 99 and / or 899 comprising an electronic switch), and each ultrasound array 850 can be configured to be independently activated via the electronic switch. Shaft assembly 130 of treatment device 100 comprises a shaft, and two or more ultrasound arrays 850 can be located on and / or within the shaft of assembly 130, the arrays 850 located in a sequential axial arrangement. In these embodiments, the ultrasound arrays 850 can be configured to produce image data ID via rotation of the associated array 850. In some embodiments, two ultrasound arrays 850 are connected by a hinge or other articulation element 95, for example, such that RMA 300 can change the angle between the two arrays 850 (e.g., an adjustment of a “hinge angle” or other “articulation angle”).

[0248]

[0256] One or more ultrasound arrays 850 can be attached to an articulation element 95, such that each array 850 can be rotated and / or otherwise articulated to position the array 850 relative to a tissue surface (e.g., to position the array 850 to maximize contact with the tissue surface for efficient delivery of ultrasound to the tissue), such as a tissue surface comprising a wall of the uterus and / or a tissue surface of the tongue.

[0249]

[0257] In some embodiments, an ultrasound array 850 can be attached to a first portion of an articulation element 95, and a portion of shaft assembly 130 of treatment device 100 is connected to a second portion of the articulation element 95. In these embodiments, RMA 300 can be configured to adjust (e.g., precisely adjust) the angle between the ultrasound array 850 and the shaft assembly 130 (e.g., to safely and effectively position array 850 relative to the wall of the uterus, the surface of the tongue, and / or another tissue surface). In some embodiments, ultrasound array 850 can be attached to a first portion of an articulation element 95, and a portion (e.g., a manipulating arm) of RMA 300 is connected to a second portion of the articulation element 95. In some embodiments, system 10 comprises a pressure sensor (e.g., a sensor 90 comprising a pressure sensor), and a signal produced by the pressure sensor is used to position (e.g., optimize the position) the ultrasound array 850 along a tissue surface (e.g., a surface of the uterus or tongue), such as to optimize delivery of ultrasound into tissue.

[0258] Treatment assembly 150 of treatment device 100 can include one or more ultrasound arrays 850 that are configured to deliver ultrasound energy to: produce image data ID; ablate, stimulate, and / or otherwise treat tissue; or both. In some embodiments, a first ultrasound array 850a is configured to at least produce image data ID, and a second ultrasound array 850b is configured to at least treat tissue.

[0250]

[0259] Robotic manipulation assembly 300 can comprise one, two, three, or more robotically manipulatable arms, arms 350 shown, such as to robotically manipulate treatment assembly 150, ultrasound assembly 800, STTT 920, and / or other system 10 component. In some embodiments, a first arm 350a is configured to move along a first axis, and a second arm 350b is configured to move along a second axis, wherein the first axis is relatively orthogonal to the second axis. System 10 can further comprise a second imaging device, such as second imaging device 960, and an arm 350a can be configured to be manipulated based on the image data ID produced by ultrasound assembly 800, and a second arm 350b can be configured to be manipulated based on image data ID produced by the second imaging device.

[0251]

[0260] In some embodiments, arms 350 comprise at least one robotically manipulatable arm configured in a snake-robot arrangement.

[0252]

[0261] RMA 300 can comprise one or more control cables (e.g., a functional element 399 comprising one or more control cables), and the translation of each control cable can be configured to manipulate at least a portion of a system 10 component. For example, translation of a control cable can be configured to manipulate a distal portion of treatment device 100.

[0253]

[0262] In some embodiments, system 10 comprises a component with one or more magnetic elements (e.g., a functional element 99 comprising one or more magnets or magnetic material), and RMA 300 can be configured to manipulate the system 10 component (e.g., manipulate a distal or other portion of the component) by applying magnetic forces to the magnetic element.

[0254]

[0263] RMA 300 can be configured to perform at least a 45 degree rotation of a system 10 component, such as when a first ultrasound array 850a of ultrasound assembly 800 is rotated by RMA 300 to increase the volume of target tissue ablated by the ultrasound assembly 800. RMA 300 can be configured to perform at least a 180 degree rotation of the first ultrasound array 850a, such as to ablate a “full circle” of target tissue.

[0264] System 10 can include one or more force measurement assemblies, force measurement assembly 400 shown. Force measurement assembly 400, also referred to as FMA 400 herein, can be configured to measure the force applied to one, two, or more system 10 components (e.g., treatment device 100, treatment assembly 150, ultrasound assembly 800, STTT 920, and / or other system 10 component), such as to measure one or more system 10 components that are configured to be manipulated by the RMA 300. RMA 300 can be configured to maintain the force applied to a system 10 component, and / or the force applied by a system 10 component to tissue, to a force below a threshold, such as a force limitation achieved via one or more measurements performed by FMA 400. System 10 (e.g., via algorithm 55) can be configured to determine clinically relevant force thresholds that relate to the current anatomical location of a system 10 component (e.g., ultrasound assembly 800), and based on force measurement and associated force data provided by FMA 400, cause RMA 300 to robotically manipulate the system 10 component while preventing the system 10 component from applying a force to tissue that exceeds the force thresholds for that particular tissue (e.g., that particular tissue type). The current anatomical location can be determined based on image data ID, and anatomical model AM, each as described herein.

[0255]

[0265] System 10 can comprise one, two, or more tissue manipulators, tissue manipulating assembly 500 shown. Tissue manipulating assembly 500, also referred to as TMA 500 herein, can be configured to manipulate the target tissue and / or other tissue of the patient. In some embodiments, RMA 300 is configured to robotically manipulate TMA 500. TMA 500 can comprise one or more tissue manipulating elements, tissue manipulating element 550 shown, such as an element selected from the group consisting of: a balloon; an expandable cage; an unfurlable element; an expandable element; and combinations of these. Treatment device 100 can comprise all or a portion of TMA 500, such as when TMA 500 is configured to cause treatment device 100 to safely move along the wall of the uterus (e.g., tissue manipulating element 550 comprises one or more balloons positioned on shaft assembly 130 of treatment device 100, the balloons configured to atraumatically contact the wall of the uterus).

[0256]

[0266] System 10 can comprise one, two, or more localization assemblies, localization assembly 600 shown. Localization assembly 600, also referred to as LA 600, can comprise one or more localization elements, localization element 650 shown. LA 600 can be configured to produce anatomical location data and / or other location data related to the anatomical and / or other location of a system 10 component intended to be localized. RMA 300 can be configured to robotically manipulate LA 600. Localization element 650 can comprise one or more: magnetic markers; orthogonal coils; radiopaque markers; electrically conductive and / or otherwise electromagnetic markers; and / or ultrasonically visible markers, such as to localize a system 10 component with 6 degrees of freedom. LA 600 can provide information about the location and / or orientation information related to the roll, pitch, and / or yaw of a system 10 component. LA 600 can be configured to provide 2D anatomical location information, 3D anatomical location information, or both. LA 600 can be configured to provide anatomical location information of treatment assembly 150 and / or another portion of treatment device 100, ultrasound assembly 800 (e.g., when ultrasound assembly 800 is part of treatment device 100 and / or another patient-insertable probe), and / or of another system 10 component. LA 600 can be configured to produce anatomical location information of a system 10 component based on both data provided by localization element 650 as well as image data ID (e.g., as provided by ultrasound assembly 800, second imaging device 960, and / or another imaging device of system 10). System 10 can be configured to produce an image of the patient anatomy and one, two, or more system 10 components that have been localized by LA 600, in a registered arrangement. System 10 can be configured to cause RMA 300 to perform a robotic manipulation based on both image data ID as well as the anatomical location information produced by LA 600.

[0257]

[0267] System 10 can comprise one, two, or more ablation assessment assemblies, ablation assessment assembly 910 shown. Ablation assessment assembly 910 can be configured to: produce data related to the ablation of the target tissue and / or other tissue; predict quality of a future ablation; or both. RMA 300 can be configured to robotically manipulate ablation assessment assembly 910. System 10 (e.g., via algorithm 55) can be configured to prevent a tissue treatment if a prediction of ablation assessment assembly 910 is below a threshold.

[0258]

[0268] As described herein, console 200, and / or another system 10 component, can collectively comprise one or more algorithms, algorithm 55 shown, that are stored as instructions 53 in memory 52, for implementation by processor 51. Algorithm 55 can comprise an artificial intelligence (Al) algorithm, also as described herein. In some embodiments, algorithm 55 is configured to produce an anatomical model AM based on, at least, image data ID. The anatomical model can comprise two or more sets of image data that are “stitched” together by algorithm 55. Algorithm 55 can be configured to produce the model AM based on one or more landmarks that are identified in the image data ID. Algorithm 55 can be configured to identify one or more features of interest in the anatomical model AM. The one or more features of interest can comprise one or more features selected from the group consisting of fibroid tissue; tumor tissue; margin tissue; blood vessel; duct; target tissue; safety margin tissue; non-target tissue; and combinations of these. Algorithm 55 can be configured to automatically perform a robotic manipulation, via RMA 300, based on the anatomical model and the one or more features of interest. Algorithm 55 can be configured to prevent a manual robotic manipulation (e.g., via an operator using RMA 300) based on the anatomical model and the one or more features of interest (e.g., to prevent compromising patient safety). Algorithm 55 can be configured to prevent a delivery of energy (e.g., via treatment device 100, ultrasound assembly 800, and / or STTT 920) based on the anatomical model and one or more features of interest. Algorithm 55 can be configured to prevent a delivery of energy (e.g., via treatment device 100, ultrasound assembly 800, and / or STTT 920) based on a current position and / or orientation of an energy delivery component relative to target tissue and / or the current position and / or orientation of the energy delivery component relative to non-target tissue. Algorithm 55 can be configured to prevent a delivery of energy (e.g., via treatment device 100, ultrasound assembly 800, and / or STTT 920) based on image data ID that comprises blood flow information (e.g., doppler and / or other blood flow information provided by ultrasound assembly 800).

[0259]

[0269] Algorithm 55 can be configured to identify non-target tissue in the anatomical model AM, and system 10 can be configured to limit energy delivery (e.g., via treatment device 100, ultrasound assembly 800, and / or STTT 920) to the non-target tissue using the anatomical model AM. The non-target tissue can comprise: blood vessel tissue; tissue proximate a blood vessel; nerve tissue; and / or tissue proximate a nerve. Algorithm 55 can be configured to identify a blood vessel proximate to the target tissue, such as when system 10 is configured to ablate the blood vessel that is proximate the target tissue, and / or avoid ablating and / or otherwise damaging the blood vessel that is proximate the target tissue.

[0260]

[0270] Algorithm 55 can be configured to compensate for tissue movement when creating the anatomical model AM. Image data ID can comprise image data that is collected prior to the occurrence of the tissue movement. Algorithm 55 can be configured to adjust the “trajectory” (e.g., a 2D or 3D movement path) of a system 10 component based on an assessment of the tissue movement. Algorithm 55 can be configured to predict patient movement and / or other tissue movement. System 10 can comprise a second imaging device (e.g., second imaging device 960), and algorithm 55 can be configured to create the image data ID by combining first image data received from ultrasound assembly 800 and second image data received from the second imaging device (e.g., an MRI).

[0261]

[0271] Algorithm 55 can be configured to produce an anatomical model AM (e.g., a 3D model) that comprises a high-resolution portion and one or more low-resolution portions. System 10 can be configured to gather additional data and to transform at least one low- resolution portion of the anatomical model AM to a portion with increased resolution. RMA 300 can be configured to robotically manipulate ultrasound assembly 800 and / or another system 10 component (e.g., second imaging device 960) to gather the additional data. System 10 can comprise a library of anatomical model templates, and algorithm 55 can be configured to produce the anatomical model AM based on both one or more of the anatomical templates, as well as the image data ID (image data ID including data identifying tumor tissue and / or other types of target tissue, such as a tissue type identified using ultrasonically-reflective tissue markers, photoacoustic tags, or both). RMA 300 can be configured to automatically manipulate treatment device 100 and / or another system 10 component based on the anatomical model. The automatic manipulation can be further based on location of target tissue. The automatic manipulation can be further based on a pre-determined trajectory map (e.g., a map of one or more previous, current, and / or future trajectories of a system 10 component), the manipulation configured to optimize image data collection. Algorithm 55 can comprise an artificial intelligence algorithm configured to: determine the pre-determined trajectory; determine a sequence of treatment locations; or both.

[0262]

[0272] Algorithm 55 can be configured to produce anatomical model AM based on properties of one or more materials in the acoustic pathway of ultrasound assembly 800 when producing the image data. Algorithm 55 can be configured to cause RMA 300 to cause a system 10 component (e.g., treatment device 100, ultrasound assembly 800, STTT 920, and / or another system 10 component) to navigate within a portion of the patient’s anatomy included in the anatomical model.

[0263]

[0273] Algorithm 55 can comprise an Al or other algorithm that is configured to identify one or more volumes of target tissue to be ablated, stimulated, and / or otherwise treated by system 10. The one or more volumes of target tissue can comprise: one or more fibroids; one or more volumes of tongue tissue; one or more volumes of soft palate tissue; one or more volumes of tonsil tissue; and / or one or more volumes of tumor tissue, such as one or more volumes of tumor tissue positioned behind a bone. System 10 can be configured to gather

[0264] -n - image data ID from an MRI, and algorithm 55 can be configured to produce anatomical model AM based on the image data ID from the MRI.

[0265]

[0274] Algorithm 55 can be configured to determine a desired change in a field of view of an ultrasound array 850 (e.g., a 1.5D array), such as when system 10 is configured to perform an electronic focus adjustment of the ultrasound assembly; translate and / or rotate the ultrasound array 850; or both. Ultrasound array 850 and / or another system 10 component can comprise at least one pressure sensor and / or other sensor (e.g., a functional element 899 and / or 99 comprising a pressure sensor and / or other sensor), and each sensor can be configured to produce a sensor signal. Algorithm 55 can be configured to determine a force applied to a tissue surface by an ultrasound array 850, the force determination based on: the sensor signals; image data ID; or both. RMA 300 can be configured to reposition the ultrasound array 850 if the applied force exceeds a threshold (e.g., a repositioning that reduces the force applied to a level below the threshold).

[0266]

[0275] Algorithm 55 can be configured to modify the field of view of an ultrasound array 850 of ultrasound assembly 800 based on patient movement detected by algorithm 55, such as when algorithm 55 is configured to detect the patient movement by analyzing image data ID. Target tissue can comprise a first volume of tissue, and algorithm 55 can be configured to determine if the field of view of an ultrasound array 850 is sufficient (e.g., currently sufficient) to treat the first volume of tissue in its entirety (e.g., without movement of array 850). If algorithm 55 determines that the field of view of an ultrasound array 850 is insufficient to treat the first volume of tissue in its entirety, algorithm 55 can be further configured to cause RMA 300 to translate and / or rotate the first ultrasound array to change the field of view such that the first volume of tissue can be treated in its entirety. In some embodiments, algorithm 55 is configured to minimize movement of ultrasound assembly 800 (e.g., minimize movement of one or more ultrasound arrays 850) in treating one, two, or more volumes of target tissue in their entirety (e.g., via electronic focus adjustments or other means).

[0267]

[0276] The target tissue to be treated can comprise multiple volumes of target tissue, and algorithm 55 can be configured to analyze image data ID, and based on the analysis cause RMA 300 to robotically manipulate (e.g., automatically manipulate, manually manipulate, or both) an energy delivery component (e.g., treatment assembly 150, ultrasound assembly 800, and / or STTT 920) along a trajectory to treat the multiple volumes of target tissue. System 10 can be configured to gather additional image data ID during the robotic manipulation of the energy delivery component, and algorithm 55 can be configured to adjust a trajectory (and / or adjust a trajectory map comprising one or more actual and / or potential trajectories) based on an analysis of the additional image data ID. The additional image data ID can comprise data of lower resolution and / or higher resolution than the resolution of the previous image data ID.

[0268]

[0277] Algorithm 55 can comprise a bias. For example, algorithm 55 can be configured to determine a trajectory map to be used by RMA 300 to robotically manipulate a system 10 component, and the algorithm 55 can be configured to bias one or more trajectories of a trajectory map toward one or more tissue types and / or away from one or more tissue types and / or one or more anatomical locations (e.g., bias a path to be taken by a system 10 component toward and / or away from one or more tissue types and / or one or more anatomical locations). In some embodiments, algorithm 55 is configured to determine a trajectory map based on image data ID comprising at least photoacoustic data (e.g., photoacoustic data collected as described herein).

[0269]

[0278] As described herein, system 10 can comprise processing unit 50 which can include processor 51 including at least one processor. Processing unit 50 can be operatively connected to RMA 300, and processing unit 50 can be configured (e.g., algorithm 55 can be configured) to control RMA 300 to provide a treatment procedure (e.g., a medical procedure as described herein) to the patient according to a “treatment plan” that includes treating multiple volumes of tissue within a target tissue volume. RMA 300 can be configured to provide the treatment procedure by: controlling RMA 300 to mechanically position a first field of view of ultrasound assembly 800 within a first of the multiple volumes of tissue to be treated; delivering ultrasound energy with ultrasound assembly 800 to treat the first volume of tissue; controlling RMA 300 to mechanically position a second field of view of ultrasound assembly 800 within a second of the multiple volumes of tissue to be treated; and delivering ultrasound energy with ultrasound assembly 800 to treat the second volume of tissue. The treatment plan can be based on the image data ID (e.g., such as when algorithm 55 assists in the creation of the treatment plan, using the image data ID). The image data ID used can comprise at least doppler ultrasound data.

[0270]

[0279] As described herein, system 10 can comprise one or more user interfaces, user interface 60 shown, which can be configured to provide information to an operator of system 10, and / or receive information (e.g., commands) from an operator of system 10. User interface 60 can comprise one, two, or more of user input device 61; user output device 62; display 63; touchscreen; button; switch; lever; footswitch; user-mountable assembly; head- mountable assembly; and combinations thereof. User interface 60 can comprise a user- mountable assembly configured to attach to a first user, and the user-mountable assembly can be configured to provide information to the user and / or receive information from the user. A user-mountable assembly of user interface 60 can be configured to mount to the head of a user. A user-mountable assembly can be configured to track movement (e.g., head movement, arm movement, and / or foot movement) of a user. System 10 (e.g., via algorithm 55) can be configured to correlate a tracked movement to a gesture, and the gesture can be assigned to a function of system 10 (e.g., a function of RMA 300, such as a robotic manipulation of a treatment device 100 and / or another system 10 component performed by RMA 300). The correlation of the gesture can be further based on input from an additional user input component of system 10 (e.g., one or more components of user input device 61). The function to which the gesture is assigned can comprise a function selected from the group consisting of: movement of RMA 300; creation of an image (e.g., initiation and control of ultrasound assembly 800 to produce image data ID from which an image can be created); delivery of energy (e.g., delivery of energy from treatment device 100, ultrasound assembly 800, and / or STTT 920); and combinations of these. User interface 60 can comprise a user feedback component (e.g., a user output device 62 for providing information to a user), wherein the user feedback component is configured to provide alert information and / or other information to an operator of the system. The alert information and / or other information can comprise information provided as haptic feedback, audible feedback, or both. The alert information and / or other information can comprise information related to temperature of target tissue, temperature of non-target tissue, or both. The alert information and / or other information can comprise information related to positioning of an energy delivery component of the system relative to: target tissue, non-target tissue, or both. The feedback provided can comprise visual feedback, such as visual feedback comprising images of the patient’s anatomy and / or images of one or more system 10 components (e.g., images indicating the position of one or more system 10 components relative to target tissue and / or relative to non- target tissue). The alert information and / or other information can comprise information related to the level of ablation of target tissue.

[0271]

[0280] As described herein, system 10 can comprise one, two or more sensors, sensor 90 shown. Each sensor of sensor 90 and / or other sensor of system 10 can be configured to produce a sensor signal representing one or more patient parameters, system 10 parameters, and / or environmental parameters being monitored by the sensor. RMA 300 can be configured to robotically manipulate the sensor 90 (e.g., to position the sensor 90 in a particular anatomical location and / or other desired location to monitor a parameter). Treatment device 100 (e.g., treatment assembly 150 or other portion of treatment device 100), ultrasound assembly 800, RMA 300, STTT 920 and / or another component of system 10 can comprise one, two, or more sensors of sensor 90. In some embodiments, one or more ultrasound arrays 850 each comprise at least one pressure sensor, such as at least three or at least four pressure sensors. For example, pressure sensors can be positioned on all four sides of a rectangular array of ultrasound transducers 855 of an ultrasound array 850. Signals from the pressure sensors can be used (e.g., by RMA 300) to properly position the array 850 on a tissue surface (e.g., the wall of the uterus, a surface of tongue tissue, and / or the surface of a tumor). Alternatively or additionally, one or more pressure sensors of ultrasound array 850 (e.g., sensors on all four sides of a rectangular array of ultrasound transducers 855 of an ultrasound array 850) can be used to monitor force applied to tissue, such as to prevent applying force above a threshold, and / or cause system 10 to enter an alert state if an applied force exceeds a threshold. Alternatively or additionally, one or more pressure sensors of ultrasound array 850 (e.g., sensors on all four sides of a rectangular array of ultrasound transducers 855 of an ultrasound array 850) can be used to monitor force applied to tissue to confirm there is adequate contact between array 850 and tissue prior to delivery of ultrasound energy to the tissue (e.g., proper contact including prevention of air bubbles or other gaps between array 850 and tissue). In some embodiments, signals from one or more sensors of ultrasound assembly 800 are used by RMA 300 and / or another system 10 component to: maintain contact between tissue and ultrasound array 850 above a minimum threshold; prevent force applied by ultrasound array 850 to tissue below a maximum threshold; or both.

[0272]

[0281] Sensor 90 can comprise one or more thermocouples, infrared cameras, and / or other temperature sensors.

[0273]

[0282] As described herein, system 10 can comprise surgical tissue treatment tool 920 shown. Surgical treatment tool 920, also referred to as STTT 920, can comprise a tool used by an operator (e.g., a clinician) to treat the patient, such as to ablate and / or otherwise treat target tissue of the patient. RMA 300 can be configured to robotically manipulate STTT 920. STTT 920 can be configured to treat tissue via a delivery of energy comprising energy in a form selected from the group consisting of radiofrequency energy, microwave energy, and / or other electromagnetic energy; laser energy and / or other light energy; thermal energy such as hot fluid energy and / or cryogenic energy; ultrasound energy; mechanical energy; chemical energy; and combinations thereof. In some embodiments, treatment device 100 comprises STTT 920 (e.g., device 100 comprises at least a portion of STTT 920), such as when STTT 920 is configured to deliver energy to perform a target tissue treatment. Image data ID (e.g., image data ID produced using ultrasound assembly 800, second imaging device 960, and / or other system 10 component) is used (e.g., by algorithm 55) to create a trajectory map for the STTT 920 (e.g., a trajectory map comprising one or more potential trajectories through which STTT 920 can be manipulated). The trajectory map can comprise and / or be based on information selected from the group consisting of: target tissue location information; nontarget tissue location information; trajectory depth information; ablation depth information; margin information; blood vessel location information; and combinations thereof.

[0274]

[0283] In some embodiments, STTT 920 is configured to treat a first volume of target tissue, and ultrasound assembly 800 is configured to treat a second volume of the target tissue. The first volume of target tissue can be a larger tissue volume than the second volume of target tissue. The first volume of target tissue can comprise at least 50% of the volume of a fibroid, such as when the second volume of target tissue comprises one or more margins of a fibroid. The second volume of target tissue can comprise a non-vascular volume of tissue. Ultrasound assembly 800 can be configured to treat one or more other volumes of target tissue, such as when each of the other volumes of target tissue is less than the first volume of target tissue treated by STTT 920.

[0275]

[0284] Ultrasound assembly 800 can be configured to perform a cauterization procedure. In some embodiments, STTT 920 comprises a radiofrequency delivery needle and / or other needle, and a cauterization performed by ultrasound assembly 800 cauterizes a puncture tract of the radiofrequency delivery needle and / or other needle.

[0276]

[0285] Ultrasound assembly 800 can be configured to deliver a plane of HIFU energy, such as a plane of HIFU energy that “marks” a boundary in tissue. STTT 920 can be configured to treat a volume of target tissue based on the marked boundary. The plane of HIFU energy can be configured to ablate margin tissue of the target tissue.

[0277]

[0286] As described herein, system 10 can comprise one, two, or more body introduction devices, introduction device 930 shown, for introducing treatment device 100, ultrasound assembly 800, STTT 920, and / or another system 10 component into the body of a patient. RMA 300 can be configured to robotically manipulate introduction device 930. Introduction device 930 can comprise a device selected from the group consisting of: sheath; trocar; vascular introducer; laparoscopic port; endoscope; and combinations thereof.

[0287] As described herein, system 10 can comprise one, two, or more augmented reality devices, augmented reality device 940 shown. Augmented reality device 940 can be configured to provide images and / or other information to an operator in an augmented reality arrangement, such as images and / or other information that is based on the image data and / or other data produced by the system.

[0278]

[0288] System 10 can be configured to deliver light, such as light delivered to tissue, an implant, and / or other material. For example, treatment device 100 (e.g., via a light-delivering functional element 199), robotic manipulation assembly 300 (e.g. via a light-delivering functional element 399), tissue manipulation assembly 500 (e.g., via a light-delivering functional element 599), localization assembly 600 (e.g., via a light-delivering functional element 699), ultrasound assembly 800 (e.g., via a light-delivering functional element 899), and / or another component of system 10 (e.g., via a light-delivering functional element 99 or other functional element), can comprise a laser diode or other light-delivering component configured to deliver light (e.g., pulsed light) to one or more locations of a patient. System 10 (e.g., console 200 and / or second imaging device 960) can include a laser (e.g., a functional element 299 comprising a laser) configured to provide the light to the light-delivering element. The laser can be configured to generate light pulses in the nanosecond range (5ns to 100ns) with repetition rates ranging from kHz to MHz. In these embodiments, system 10 can be configured to perform photoacoustic imaging (PAI) in which the light-delivering element delivers pulsed light, and the tissue and / or other material receiving the light is excited (e.g., due to thermal expansion), such that the excited material produces sound waves. The sound waves can be received by one or more ultrasound transducers of system 10 (e.g., USTs 855) such that system 10 can produce one or more images (e.g., image data ID herein) of the excited tissue and / or other material based on the received sound waves. In some embodiments, the pulsed light delivered by system 10 comprises light delivered at multiple, different pulse rates, such as to differentiate between multiple different photoacoustic tags. Additionally, or alternatively, physiologic information of the patient can be produced based on the produced sound waves, such as information related to fluid flow (e.g., blood flow), and / or blood oxygenation. In some embodiments, robotic manipulation assembly 300 is configured to robotically manipulate a functional element that is delivering the light to perform PAI and / or that is otherwise producing functional information (e.g., robotic manipulation of functional element 99, 199, 399, 499, 599, 699, and / or 899). System 10 can be configured to perform PAI to identify and / or locate target tissue to be treated using system 10 (e.g., target tissue to be ablated, stimulated, and / or otherwise treated using treatment device 100 and / or another component of system 10).

[0279]

[0289] System 10 can include an agent 30 comprising one, two, or more “photoacoustic tags” (singly or in multiple, “photoacoustic tag” or “photoacoustic tags” herein). System 10 can be configured to detect (e.g., register in 3D space and / or otherwise locate), using photoacoustic imaging, a photoacoustic tag that has been delivered to the patient. The photoacoustic tag can be configured to attach to (e.g., attach to, be absorbed by, be positioned on or within, and / or otherwise be co-located with) a target material (e.g., based on an affinity to the target material or a material present within the target material), such as a target material comprising tumor tissue. One or more photoacoustic tags can be configured to attach to one or more particular proteins (e.g., tens, or hundreds of proteins), such as one or more proteins associated with a particular target tissue of interest (e.g., target tissue comprising tumor tissue, uterine fibroid tissue, base of tongue tissue, and / or other tissue). Based on the detection of the photoacoustic tag, system 10 can be further configured to treat (e.g., ablate, stimulate, and / or otherwise treat) tissue and / or other material to which the photoacoustic tag has attached and / or tissue or other material that is proximate the photoacoustic tag. For example, agent 30 can comprise a photoacoustic tag configured to be attached to a type of tissue selected from the group consisting of: tumor tissue (e.g., a particular type of tumor tissue); fat tissue; fibroid tissue; soft palate tissue; tongue tissue; lung tissue; brain tissue; heart tissue; and combinations of one or more of these. Agent 30 can comprise a photoacoustic tag for one or more antibodies. Agent 30 can comprise a photoacoustic tag selected from the group consisting of: an antibody-dye, such as a near-infrared dye; a small molecule dye and / or fluorophore such as indocyanine green, a J-aggregate, an ultraphotostable dye, and / or a nitro oxide-responsive nanosensor; a metallic nanoparticle such as a gold nanoparticle, a silver nanoparticle, and / or an iron-based nanoparticle; a polymer- based nanomaterial such as a napththalocyanine dye-loaded nanoparticle and / or a semiconducting homopolymer nanoplatform; a quantum dot; a radiation-damaged nanodiamond, a polypyrrole nanoparticle; a copper sulfide nanoparticle; a graphene nanosheet; an iron oxide-gold core-shell nanoparticle; a Gd203-DEG-gelatin nanoparticle; a dye-loaded perfluorocarbon-based nanoparticle; a gold microbubble; any photoacoustic contrast agent; and combinations of these.

[0280]

[0290] Agent 30 can comprise one, two, or more photoacoustic tags that are configured to identify one or more reference points in target tissue (e.g., reference points of a tumor). For example, agent 30 can comprise a photoacoustic tag used to identify a “boundary” of tumor tissue, after which the tumor (e.g., the entire tumor) can be treated using system 10 (e.g., ablated via HIFU, histotripsy, and / or other ablative ultrasound energy delivered by USTs 855).

[0281]

[0291] As described hereinabove, system 10 can be configured to perform photoacoustic imaging that creates image data ID that is used to identify the anatomical location of target tissue to be treated using system 10. For example, PAI can be performed via the delivery of light via a functional element of system 10 (e.g., a light-delivering functional element 99, 199, 399, 499, 599, 699, and / or 899), where target tissue is identified via an agent 30 comprising a photoacoustic tag configured to attach to a particular type of target tissue. Based on the PAI identification, system 10 (e.g., treatment device 100) can be configured to ablate, stimulate, and / or otherwise treat the identified target tissue. In some embodiments, system 10 is further configured to locate the target tissue using image data ID created via the delivery of ultrasound energy (e.g., ultrasound energy that is delivered and / or received by USTs 855 as described herein). In these embodiments, identification, treatment, or both, of target tissue is performed by system 10 using both ultrasound imaging (e.g., imaging performed via both the delivery of ultrasound energy and receiving of reflections of the ultrasound energy) and PAI. In these embodiments, the delivering of the ultrasound energy (e.g., via USTs 855) to produce a first set of image data ID, and the delivering of the light (e.g., via a light-delivering functional element 99, 199, 399, 499, 599, 699, and / or 899), can be performed in a sequential manner, such as to differentiate the received ultrasound energy resulting from the delivery of light versus those resulting from the delivery of sound. In some embodiments, the target tissue to be treated is located at least 10mm, 20mm, 30mm, 40mm, and / or 50mm from the functional element delivering the light, and / or the ultrasound transducer UST 855 delivering ultrasound energy.

[0282]

[0292] In some embodiments, algorithm 55 (e.g., an Al or other algorithm) is configured to analyze image data ID (e.g., image data ID comprising PAI data and / or ultrasound imaging data as described hereinabove) in order to identify (e.g., and spatially locate) one or more photoacoustic tags (e.g., agent 30 comprising one or more photoacoustic tags). In these embodiments, algorithm 55 can be further configured to determine one or more energy delivery settings which are used by system 10 in the delivery of treatment energy by treatment device 100 (e.g., ultrasound energy delivered by USTs 855 to ablate, stimulate, and / or otherwise treat target tissue). In some embodiments, robotic manipulation assembly 300 is configured to orient the USTs 855 toward the identified target tissue, such as via orientation instructions produced by algorithm 55. In these embodiments, RMA 300 can be configured to accommodate for patient movement (e.g., respiration and / or other autonomous movement of patient tissue). In some embodiments, algorithm 55 is configured to divide the target tissue (e.g., tumor tissue) into two or more volumes of tissue to be treated independently. In some embodiments, RMA 300 and / or algorithm 55 can be configured to orient USTs 855 in a direction corresponding to an increased density and / or magnitude of sound waves produced by tissue excited by light delivered from system 10. For example, system 10 can be configured to provide treatment to tissue in an area comprising a high density (e.g., of relatively high density compared to surrounding tissue) of photoacoustic tags without specifically determining the precise location of one or more of the photoacoustic tags. In some embodiments, system 10 (e.g., algorithm 55) is configured to produce an anatomical model of tissue of the patient, identifying the location of one or more photoacoustic tags located using PAI data, such that the tissue associated with the photoacoustic tags can be treated (e.g., ablated, stimulated, and / or otherwise treated by treatment device 100) using the anatomical map. In some embodiments, RMA 300 robotically manipulates treatment device 100 based on the anatomical model created using PAI data.

[0283]

[0293] System 10 of Fig. 1 A can be of similar construction and arrangement as system 10 of Figs. 1, 3, 4, 5, and / or 6 described herein.

[0284]

[0294] Referring now to Figs. 2A and 2B, schematic views of a ID ultrasound array and a 1.5D ultrasound array are illustrated, respectively, consistent with the present inventive concepts. Ultrasound array 850 and / or other components of system 10 of Figs. 2A and 2B can be of similar construction and arrangement as the similar components described in reference to Fig. 1, Fig. 1A, and otherwise herein.

[0285]

[0295] Fig. 2A shows a schematic view of an embodiment of ultrasound array 850 comprising a ID ultrasound array. Fig. 2B shows a schematic view of an embodiment of ultrasound array 850 comprising a 1.5D ultrasound array. Each array 850 comprises an azimuth (e.g., a length, or X dimension), an elevation (e.g., a height, or Y dimension), and can project ultrasonic signals in an axial direction (e.g., the Z direction).

[0286]

[0296] A ID array, as shown in Fig. 2A, can comprise a single row of ultrasound transducers 855 that extend along the azimuth of the array. The elevation performance (e.g., the focusing ability of array 850 relative to the elevation of the array) is determined by a fixed physical aperture and a fixed focus determined by a mechanical lens (e.g., the focus of the array is fixed relative to the elevation of the array).

[0287]

[0297] A “1.5D array”, as shown in Fig. 2B, can comprise the components of a ID array with additional rows of transducers 855, such as an array 850 that includes a center row of transducers 855a, and outer rows of transducers 855b positioned on either side of the center row, as shown (e.g., outer rows of transducers positioned symmetrically about the center row). The rows of transducers 855a and 855b can be phased (e.g., ultrasonic signals delivered to drive the transducers can be phased) to dynamically focus array 850 in the elevation dimension. In some embodiments, transducers 855b on either side of the elevation center of array 850 are electrically connected (e.g., each pair of transducers 855b on either side of a transducer 855a are electrically connected). In some embodiments, an array can comprise multiple outer rows of transducers 855b (e.g., a “1.75D array”), such as two or three rows on each side of the central row (e.g., such that transducer 855 comprises five total rows, or seven total rows, respectively).

[0288]

[0298] Referring now to Fig. 3, an anatomical view of a distal portion of a treatment device positioned relative to target tissue to be treated is illustrated, consistent with the present inventive concepts. Treatment device 100 includes treatment assembly 150 positioned in a distal portion of shaft assembly 130. Treatment assembly 150 can include all or a portion of ultrasound assembly 800, which can include one or more ultrasound arrays 850, each as shown. Treatment device 100 of Fig. 3 comprises a positioning element, positioning element 131 shown, which can be configured to controllably expand to position array 850 a desired distance from tissue (e.g., tissue to be imaged, ablated and / or otherwise treated, or both). For example, positioning element 131 can be expanded to position array 850 a distance DI from a volume of target tissue TT1, as shown. RMA 300 can be configured to controllably expand, contract and / or otherwise manipulate positioning element 131. In some embodiments, positioning element 131 comprises a balloon which can be controllably expanded and / or contracted via the transfer of fluids into and / or out of, respectively, element 131 (e.g., a transfer of fluids via a functional element 199 comprising one or more lumens). In some embodiments, positioning element 131 comprises a cage, radially-deployable arms, unfurlable element, and / or other radially expandable element, such as when positioning element 131 is configured to be expanded and / or contracted via a functional element 99 comprising a mechanical linkage (e.g., a mechanical linkage that can be robotically manipulated by RMA 300).

[0299] Referring now to Fig. 4, an anatomical view of a treatment device positioned relative to target tissue via a robotic manipulation assembly is illustrated, consistent with the present inventive concepts. System 10 of Fig. 4 includes a treatment device 100 comprising treatment assembly 150 that includes ultrasound assembly 800. System 10 further includes robotic manipulation assembly 300 which is configured to robotically manipulate treatment device 100.

[0289]

[0300] RMA 300 of Fig. 4 includes arm 350 which is rotatably attached to shaft assembly 130 of treatment device 100 via hinge 351, as shown. Hinge 351 can comprise a hinge (e.g., a motorized or otherwise controllable hinge) with 1, 2, or more degrees of freedom. In Fig. 4, hinge 351 has been adjusted to angle al such that ultrasound array 850 of assembly 800 is positioned at a desired orientation relative to a volume of target tissue, volume TT1 shown. In some embodiments, treatment device 100 includes positioning element 131 (e.g., a balloon), that can be configured to position array 850 a desired distance DI from volume TT1 (also as shown). During positioning of array 850 by RMA 300 and / or positioning element 131, image data ID can be collected via the delivering of ultrasound energy and receiving of ultrasound energy by array 850 (e.g., by USTs 855 not shown for illustrative clarity), such as to aid in the positioning of array 850 in real time. Once positioned, array 850 (e.g., USTs 855) can be configured to deliver ultrasound energy to treat volume TT1, such as delivery of focused ultrasound energy (e.g., histotripsy-based or HIFU based ultrasound energy) configured to ablate volume TT1, and / or other level of ultrasound energy configured to stimulate and / or otherwise treat volume TT1.

[0290]

[0301] In some embodiments, hinge 351 can be configured in a “follow” mode and / or in a “limp” mode, where the articulation of hinge 351 is freely manipulatable by outside forces (e.g., a force applied to shaft assembly 130 by the inflation of positioning element 131). Alternatively, or additionally, hinge 351 can be configured in a “minimum force” mode and / or “maximum force” mode, where hinge 351 is configured to maintain at least a minimum force and / or limit the maximum force exerted by an element that is controlled by the articulation of hinge 351. For example, in a minimum force mode, hinge 351 can be configured to articulate towards the tissue such that at least a portion of treatment device 100 is maintained in contact with tissue with a force of at least the minimum force threshold for hinge 351 in the minimum force mode. As another example, in a maximum force mode, hinge 351 can be configured to limit the force applied by any portion of treatment device 100 to the tissue while hinge 351 articulates such that treatment device 100 advances towards the tissue (e.g., is brough into contact with the tissue). In some embodiments, hinge 351 is configured in both a minimum force mode and maximum force mode, such as to control the force applied by treatment device 100 to tissue within lower and upper bounds.

[0291]

[0302] Referring now to Fig. 5, an anatomical view of a treatment device positioned relative to target tissue and manipulated via a robotic manipulation assembly is illustrated, consistent with the present inventive concepts. System 10 of Fig. 5 includes a treatment device 100 comprising treatment assembly 150 that includes ultrasound assembly 800. System 10 further includes robotic manipulation assembly 300 which is configured to robotically manipulate treatment device 100.

[0292]

[0303] RMA 300 and other components of system 10 of Fig. 5 include similar components and configurations to those described in reference to Fig. 4 herein. Treatment device 100 includes an ultrasound array 850 comprising an array of transducers 855 positioned on a flexible substrate, substrate 856. RMA 300 of Fig. 5 further includes cable 352 which is configured to change the shape of ultrasound array 850, such as by applying a force to substrate 856 to cause array 850 to transition from a linear geometry to the geometry shown in Fig. 5 defined by angle a2 as shown. Ultrasound array 850 can be configured to transition between a first geometry, such as a linear geometry, and a convex curvilinear geometry (e.g., convex relative to the target tissue as shown) that is defined by angle a2. Alternatively, or additionally, ultrasound array 850 can be configured to transition to a concave curvilinear geometry (e.g., concave relative to the target tissue). Angle a2 can comprise an angle of up to 90° (e.g., such that ultrasound array 850 comprises a 90° curvilinear bend).

[0293]

[0304] Referring now to Fig. 6, a system for performing a medical procedure on a patient using a robotic manipulation assembly comprising three independently controllable arms is illustrated, consistent with the present inventive concepts. System 10 includes a treatment device 100 comprising multiple treatment devices (e.g. devices 100a, 100b, and 100c shown), and a robotic manipulation assembly 300 comprising three independently controllable arms (e.g., arms 350a, 350b, and 350c shown). Each arm 350 can comprise one, two, or more controllable hinges, hinge 351 (e.g., motorized or otherwise controllable hinges, three shown for each arm 350), where each hinge 351 can provide 1, 2, or more degrees of freedom. Each treatment device 100 can comprise a treatment assembly (e.g., treatment assemblies 150a, 150b, and 150c shown) that includes a corresponding ultrasound assembly (e.g., ultrasound assemblies 800a, 800b, and 800c, respectively, shown).

[0305] Multiple ultrasound assemblies 800 (e.g., two or more of assemblies 800a, 800b, and / or 800c) can be used to produce image data ID, such as image data ID that is used by RMA 300 to manipulate at least one arm 350 (e.g., one, two, or more of arms 350a, 350b, and 350c that are manipulated using an anatomical model produced by system 10 using image data ID). In some embodiments, image data ID produced by one assembly 800 of one arm 350 (e.g., assembly 800a of arm 350a), is used to manipulate a different arm (e.g., manipulate arm 350b or 350c). In some embodiments, image data ID is produced by delivering ultrasound energy from one ultrasound assembly 850 of one arm 350 (e.g., assembly 850a of arm 350a) and receiving the ultrasound energy (or reflections of the ultrasound energy) by a different ultrasound assembly 850 of a different arm 350 (e.g., received by ultrasound assembly 850b of arm 350b). In these embodiments, RMA 300 can be configured to robotically manipulate either or both arms using the image data ID produced by the combination of ultrasound assemblies 850.

[0294]

[0306] The above-described embodiments should be understood to serve only as illustrative examples; further embodiments are envisaged. Any feature described herein in relation to any one embodiment may be used alone, or in combination with other features described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the inventive concepts, which are defined in the accompanying claims.

Claims

1. WHAT IS CLAIMED IS:

1. A system for performing a medical procedure on a patient, the system comprising: a treatment device comprising a treatment assembly that is configured to perform a treatment procedure on target tissue of the patient; an ultrasound assembly comprising a set of one or more ultrasound transducers, the ultrasound assembly configured to produce image data; and a robotic manipulation assembly configured to robotically manipulate a set of one or more system components based on the image data, wherein the set of one or more system components comprises at least: the treatment assembly of the treatment device; the ultrasound assembly; or both.

2. The system according to claim 1 and / or any other one or more claims herein, wherein the system is configured to produce an anatomical model based on the image data.

3. The system according to claim 2 and / or any other one or more claims herein, wherein the anatomical model comprises a 2D model, a 3D model, or both.

4. The system according to claim 2 and / or any other one or more claims herein, wherein the system is configured to produce the anatomical model based on known properties of materials that are in the acoustic pathway of the ultrasound assembly.

5. The system according to claim 2 and / or any other one or more claims herein, wherein the anatomical model comprises actual and / or projected temperature information associated with a current and / or future ablation of target tissue.

6. The system according to claim 1 and / or any other one or more claims herein, wherein the system is configured to: collect a first set of image data; perform a first tissue treatment procedure to treat a first volume of target tissue based on the first set of image data; collect a second set of image data; and perform a second tissue treatment procedure to treat a second volume of target tissue based on the second set of image data.

7. The system according to claim 6 and / or any other one or more claims herein, wherein the second set of image data includes identification of un-treated tissue that was intended to be treated in the first tissue treatment procedure.

8. The system according to claim 1 and / or any other one or more claims herein, wherein the system comprises an energy delivery component configured to deliver energy to tissue to treat the tissue.

9. The system according to claim 8 and / or any other one or more claims herein, wherein the treatment assembly and / or another component of the treatment device comprises the energy delivery component.

10. The system according to claim 8 and / or any other one or more claims herein, wherein the ultrasound assembly comprises the energy delivery component.

11. The system according to claim 8 and / or any other one or more claims herein, further comprising a surgical tissue treatment tool that comprises the energy delivery component.

12. The system according to claim 8 and / or any other one or more claims herein, wherein the system is configured to change the current field of view of the energy delivery component via one or more of:(1) an electronic focus adjustment of the energy delivery component;(2) translation and / or rotation of the energy delivery component within a surrounding shaft; and / or(3) translation and / or rotation of a shaft that surrounds the energy delivery component.

13. The system according to claim 12 and / or any other one or more claims herein, wherein (1) has a narrower range of the collective field of view than (2), and (2) has a narrower range of the collective field of view than (3).

14. The system according to claim 12 and / or any other one or more claims herein, wherein (1) provides finer control of the adjustment of the field of view than (2), and (2) provides finer control of the adjustment of the field of view than (3).

15. The system according to claim 12 and / or any other one or more claims herein, wherein the system is configured to change the field of view of the energy delivery component via two or more of:(1) an electronic focus adjustment of the energy delivery component;(2) translation and / or rotation of the energy delivery component within a surrounding shaft; and / or(3) translation and / or rotation of a shaft that surrounds the energy delivery component.

16. The system according to claim 15 and / or any other one or more claims herein, wherein the system is configured to change the field of view of the energy delivery component via all of:(1) an electronic focus adjustment of the energy delivery component;(2) translation and / or rotation of the energy delivery component within a surrounding shaft; and(3) translation and / or rotation of a shaft that surrounds the energy delivery component.

17. The system according to claim 1 and / or any other one or more claims herein, wherein the robotic manipulation comprises a motion comprising: advancement; retraction; rotation; expansion; contraction; bending and / or other articulation; and / or other manipulation of a system component that is performed automatically by the system.

18. The system according to claim 1 and / or any other one or more claims herein, wherein the robotic manipulation comprises an automatic motion comprising: advancement; retraction; rotation; expansion; contraction; bending and / or other articulation; and / or other manipulation of a system component that is performed automatically by the system.

19. The system according to claim 1 and / or any other one or more claims herein, wherein the robotic manipulation comprises an automatic cessation of motion of a system component that is performed automatically by the system.

20. The system according to claim 1 and / or any other one or more claims herein, wherein the robotic manipulation comprises an operator-controlled manual motioncomprising: translation; rotation; expansion; contraction; bending and / or other articulation; twisting; and / or other manipulation of a system component.

21. The system according to claim 1 and / or any other one or more claims herein, further comprising an imaging device, wherein the robotic manipulation comprises robotic manipulation of the imaging device, wherein the imaging device is configured to produce additional image data, and wherein the robotic manipulation of the imaging device is based on additional image data that is produced concurrent with the robotic manipulation.

22. The system according to claim 21 and / or any other one or more claims herein, wherein the imaging device comprises the ultrasound assembly.

23. The system according to claim 1 and / or any other one or more claims herein, wherein the image data comprises data related to blood flow of the patient.

24. The system according to claim 23 and / or any other one or more claims herein, wherein the image data comprises blood flow data collected using doppler ultrasound.

25. The system according to claim 1 and / or any other one or more claims herein, wherein the ultrasound assembly is configured to be translated, rotated, articulated, and / or otherwise manipulated during the production of the image data.

26. The system according to claim 25 and / or any other one or more claims herein, wherein the ultrasound assembly is configured to be manipulated by the robotic manipulation assembly.

27. The system according to claim 26 and / or any other one or more claims herein, wherein the system is configured to perform the manipulation of the ultrasound assembly automatically.

28. The system according to claim 1 and / or any other one or more claims herein, wherein the medical procedure comprises a procedure selected from the group consisting of: a benign prostatic hyperplasia treatment procedure; an endometriosis treatment procedure; a fibroid treatment procedure, such as category 1 fibroid treatment procedure; a fallopian tube treatment procedure; a sleep apnea-reducing procedure; a tumor treatment procedure; a biopsy procedure; an agent delivery procedure; a transabdominal procedure; a transvaginal procedure; and combinations thereof.

29. The system according to claim 1 and / or any other one or more claims herein, wherein the medical procedure comprises a treatment of benign prostatic hyperplasia.

30. The system according to claim 1 and / or any other one or more claims herein, wherein the medical procedure comprises a treatment of endometriosis.

31. The system according to claim 30 and / or any other one or more claims herein, wherein the endometriosis treatment comprises delivery of high intensity focused ultrasound energy by the ultrasound assembly at a depth of no more than 7mm, 6mm, and / or 5mm from a surface of tissue.

32. The system according to claim 1 and / or any other one or more claims herein, wherein the medical procedure comprises ablation of a fibroid.

33. The system according to claim 32 and / or any other one or more claims herein, wherein the fibroid comprises a category 1 fibroid.

34. The system according to claim 32 and / or any other one or more claims herein, wherein the system is configured to ablate at least 50% of the fibroid.

35. The system according to claim 32 and / or any other one or more claims herein, wherein the ultrasound assembly is configured to produce image datacomprising data related to the fibroid and data related to ablated tissue of the fibroid.

36. The system according to claim 32 and / or any other one or more claims herein, wherein the ablation comprises automatic delivery of high intensity focused ultrasound energy by the system.

37. The system according to claim 1 and / or any other one or more claims herein, wherein the medical procedure comprises ablation of fallopian tubes.

38. The system according to claim 1 and / or any other one or more claims herein, wherein the medical procedure comprises a biopsy procedure, and wherein the treatment device comprises a biopsy needle.

39. The system according to claim 38 and / or any other one or more claims herein, wherein the biopsy procedure comprises a biopsy of the prostate.

40. The system according to claim 1 and / or any other one or more claims herein, wherein the medical procedure comprises an agent delivery procedure.

41. The system according to claim 40 and / or any other one or more claims herein, wherein the ultrasound assembly is configured to deliver ultrasound energy to cells to modify absorption of the agent by the cells.

42. The system according to claim 40 and / or any other one or more claims herein, wherein the treatment device comprises a delivery element configured to deliver the agent.

43. The system according to claim 1 and / or any other one or more claims herein, wherein the target tissue comprises two or more volumes of target tissue.

44. The system according to claim 43 and / or any other one or more claims herein, wherein the two or more volumes of target tissue comprise: two or moreadjacent volumes of target tissue; two or more non-adjacent volumes of target tissue; or both.

45. The system according to claim 43 and / or any other one or more claims herein, wherein the two or more volumes of target tissue comprise: two or more fibroids; two or more volumes of tissue of the tongue; two or more volumes of tissue of a tonsil; two or more volumes of tissue of the soft palate; and / or two or more tumors.

46. The system according to claim 1 and / or any other one or more claims herein, wherein the target tissue comprises prostatic tissue.

47. The system according to claim 46 and / or any other one or more claims herein, wherein the non-target tissue comprises tissue types selected from the group consisting of: seminal duct; verumontanum; sphincter; calcification-tissue; and combinations thereof.

48. The system according to claim 1 and / or any other one or more claims herein, wherein the target tissue comprises fibroid tissue.

49. The system according to claim 1 and / or any other one or more claims herein, wherein the target tissue comprises tissue of the tongue, the soft palate, a tonsil, or two or three of these.

50. The system according to claim 1 and / or any other one or more claims herein, wherein the target tissue comprises tissue of a blood vessel.

51. The system according to claim 50 and / or any other one or more claims herein, wherein the blood vessel comprises a blood vessel proximate other target tissue to be treated.

52. The system according to claim 1 and / or any other one or more claims herein, wherein the non-target tissue comprises tissue of a blood vessel.

53. The system according to claim 1 and / or any other one or more claims herein, wherein the target tissue comprises tumor tissue.

54. The system according to claim 53 and / or any other one or more claims herein, wherein the tumor tissue comprises tumor tissue of an organ selected from the group consisting of: lung; liver; pancreas; brain; breast; bladder; prostate; ovary; and combinations thereof.

55. The system according to claim 1 and / or any other one or more claims herein, wherein the treatment procedure comprises delivery of energy to ablate the target tissue.

56. The system according to claim 55 and / or any other one or more claims herein, wherein the energy comprises high intensity focused ultrasound energy and / or other ultrasound energy.

57. The system according to claim 55 and / or any other one or more claims herein, wherein the delivery of energy comprises delivery of energy in an energy form selected from the group consisting of: sound energy, such as ultrasound energy; light energy, such as laser light energy; thermal energy, such as heat energy and / or cryogenic energy; electromagnetic energy, such as radiofrequency energy, microwave energy, and / or electroporation energy; chemical energy; mechanical energy; and combinations thereof.

58. The system according to claim 1 and / or any other one or more claims herein, wherein the treatment device comprises at least a portion of the ultrasound assembly.

59. The system according to claim 58 and / or any other one or more claims herein, wherein the treatment device comprises a balloon, expandable cage, unfurlable element, and / or other positioning element that is located proximate the at least a portion of the ultrasound assembly.

60. The system according to claim 59 and / or any other one or more claims herein, wherein the positioning element is configured to expand and / or contract to controllably position the at least a portion of the ultrasound assembly at a determined distance from the target tissue.

61. The system according to claim 59 and / or any other one or more claims herein, wherein the expansion and / or contraction is configured to be manually controlled by an operator of the system.

62. The system according to claim 59 and / or any other one or more claims herein, wherein the expansion and / or contraction is configured to be automatically controlled by the system.

63. The system according to claim 59 and / or any other one or more claims herein, wherein the balloon is configured to receive a fluid to create an acoustic pathway comprising a fluid pathway between the at least a portion of the ultrasound assembly and the target tissue.

64. The system according to claim 1 and / or any other one or more claims herein, wherein the treatment device comprises one, two, or more devices selected from the group consisting of elongate tool; catheter; probe; laparoscopic probe; surgical tool; minimally invasive surgical tool; hand-held tool; robotically-manipulatable tool; and combinations thereof.

65. The system according to claim 1 and / or any other one or more claims herein, wherein the treatment device comprises an elongate tool.

66. The system according to claim 65 and / or any other one or more claims herein, wherein the elongate tool comprises a distal portion and a more proximal portion, wherein a first axis of the distal portion is angularly offset from a second axis of the more proximal portion, and wherein the ultrasound assembly comprises a first ultrasound array positioned in the distal portion.

67. The system according to claim 66 and / or any other one or more claims herein, wherein the first axis is offset from the second axis by an angle of at least 45 degrees, or 90 degrees.

68. The system according to claim 66 and / or any other one or more claims herein, wherein the distal portion is configured to be positioned along the wall of a uterus.

69. The system according to claim 1 and / or any other one or more claims herein, wherein the treatment device comprises a catheter.

70. The system according to claim 1 and / or any other one or more claims herein, wherein the treatment device is configured to be inserted into the patient through a device selected from the group consisting of introducer; vascular introducer; laparoscopic port; endoscope; retractor; cervical expansion device; and combinations thereof.

71. The system according to claim 1 and / or any other one or more claims herein, wherein the treatment device is configured to be inserted through a natural orifice of the patient.

72. The system according to claim 1 and / or any other one or more claims herein, wherein the treatment device is configured to be inserted through a surgical incision of the patient.

73. The system according to claim 1 and / or any other one or more claims herein, wherein the treatment device comprises an elongate shaft.

74. The system according to claim 1 and / or any other one or more claims herein, wherein the set of one or more ultrasound transducers comprises one or more CMUTs, one or more piezo-based transducers, or both.

75. The system according to claim 1 and / or any other one or more claims herein, wherein the ultrasound assembly is configured to perform the target tissue treatment procedure via the delivery of high intensity focused ultrasound and / or other ablative ultrasound energy.

76. The system according to claim 75 and / or any other one or more claims herein, wherein the system is configured to adjust the frequency of the ablative ultrasound energy delivery based on one or more of distance to the target tissue; tissue type of the target tissue; and / or characteristics of tissue between the ultrasound transducers and the target tissue.

77. The system according to claim 75 and / or any other one or more claims herein, wherein the ultrasound assembly is configured to adjust the focus of ultrasound energy delivery to ablate a first volume of target tissue and to ablate a second volume of target tissue.

78. The system according to claim 77 and / or any other one or more claims herein, wherein the system is configured to dynamically adjust the focus of the ultrasound energy delivery to the first volume of target tissue, the second volume of target tissue, or both.

79. The system according to claim 77 and / or any other one or more claims herein, wherein the system is configured to simultaneously ablate the first and second volumes of target tissue.

80. The system according to claim 1 and / or any other one or more claims herein, wherein the system is configured to interleave between delivery of ultrasound energy for collecting the image data and delivery of ultrasound energy for treating the target tissue.

81. The system according to claim 80 and / or any other one or more claims herein, wherein the system is configured to adjust the frequency of the ultrasound energy delivered to produce the image data.

82. The system according to claim 81 and / or any other one or more claims herein, wherein the system is configured to adjust the frequency of the ultrasound energy delivered to produce the image data, and wherein the adjustment is based on one or more of resolution and / or other image property of image data to be produced; distance to tissue to be imaged; tissue type of tissue to be imaged; and / or characteristics of tissue between the ultrasound transducers and the tissue to be imaged.

83. The system according to claim 80 and / or any other one or more claims herein, wherein the system is configured to dynamically adjust imaging time, treatment time, or both.

84. The system according to claim 80 and / or any other one or more claims herein, wherein the system is configured to dynamically adjust the focus of ultrasound energy for imaging, treatment, or both.

85. The system according to claim 1 and / or any other one or more claims herein, wherein the ultrasound assembly comprises a gel block configured to be positioned between the one or more ultrasound transducers and tissue.

86. The system according to claim 1 and / or any other one or more claims herein, wherein the ultrasound assembly comprises at least one ID ultrasound array.

87. The system according to claim 86 and / or any other one or more claims herein, wherein the ultrasound assembly comprises multiple ID ultrasound arrays.

88. The system according to claim 1 and / or any other one or more claims herein, wherein the ultrasound assembly comprises at least one 1.5D ultrasound array, at least one 1.75D array, and / or at least one 2D array.

89. The system according to claim 88 and / or any other one or more claims herein, wherein the ultrasound assembly comprises multiple 1.5D ultrasound arrays.

90. The system according to claim 1 and / or any other one or more claims herein, wherein the ultrasound assembly comprises a first ultrasound array with a field of view that can be adjusted by: adjusting an electronic focus of the first ultrasound array; translating and / or rotating the first ultrasound array; or both.

91. The system according to claim 90 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to perform the translation and / or rotation of the first ultrasound array.

92. The system according to claim 90 and / or any other one or more claims herein, wherein the treatment device comprises a shaft that surrounds the first ultrasound array.

93. The system according to claim 92 and / or any other one or more claims herein, wherein the system is configured to translate and / or rotate the first ultrasound array by: translating and / or rotating the shaft of the treatment device; translating and / or rotating the first ultrasound array within the shaft of the treatment device; or both.

94. The system according to claim 92 and / or any other one or more claims herein, wherein the first ultrasound array is located in a first segment of the shaft of the treatment catheter, and wherein the robotic manipulation assembly is configured to twist the first segment of the shaft to change the field of view of the first ultrasound array.

95. The system according to claim 94 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to twist the first segment at least 45 degrees, or at least 90 degrees.

96. The system according to claim 90 and / or any other one or more claims herein, wherein the system is configured to perform an electronic adjustment of the field of view of the first ultrasound array in a first plane, and to translate and / or rotate the first ultrasound array to adjust the field of view of the first ultrasound array in a second plane perpendicular to the first plane.

97. The system according to claim 96 and / or any other one or more claims herein, wherein the target tissue comprises base of tongue tissue.

98. The system according to claim 90 and / or any other one or more claims herein, further comprising a hinge, ball joint, and / or other articulation element that is attached to the first ultrasound array, wherein rotation of the first ultrasound array about the articulation element changes the field of view of the first ultrasound array.

99. The system according to claim 98 and / or any other one or more claims herein, wherein the articulation element comprises a lockable articulation element.

100. The system according to claim 98 and / or any other one or more claims herein, wherein the articulation element comprises a first articulation element and a second articulation element.

101. The system according to claim 100 and / or any other one or more claims herein, wherein the first articulation element is configured to position the first ultrasound array along a tissue surface, and wherein the second articulation element is configured to change the field of view of the first ultrasound array.

102. The system according to claim 101 and / or any other one or more claims herein, wherein the first articulation element comprises a lockable articulation element.

103. The system according to claim 98 and / or any other one or more claims herein, wherein the target tissue comprises fibroid tissue, base of tongue tissue, soft palate tissue, tonsil tissue, and / or other tissue.

104. The system according to claim 103 and / or any other one or more claims herein, wherein the target tissue comprises multiple volumes of target tissue, and wherein the multiple volumes of target tissue are treated by adjusting an electronic focus of the first ultrasound array.

105. The system according to claim 104 and / or any other one or more claims herein, wherein the multiple volumes of target tissue are treated without translating and without rotating the first ultrasound array.

106. The system according to claim 98 and / or any other one or more claims herein, wherein the ultrasound assembly comprises a first ultrasound array and a second ultrasound array, and wherein the field of view of each ultrasound array can be modified by: electronic adjustment of the focus of the ultrasound array; translation and / or rotation of the ultrasound array; or both.

107. The system according to claim 90 and / or any other one or more claims herein, wherein the system is configured to adjust the field of view of the first ultrasound array to compensate for patient movement.

108. The system according to claim 107 and / or any other one or more claims herein, wherein the first ultrasound array comprises a 1.5D array, a 1.75D array, and / or a 2D array, and wherein the system is further configured to adjust the field of view by adjusting an electronic focus of the first ultrasound array.

109. The system according to claim 1 and / or any other one or more claims herein, wherein the ultrasound assembly comprises one or more ultrasound arrays, andwherein each ultrasound array comprises one or more ultrasound transducers of the set of ultrasound transducers.

110. The system according to claim 109 and / or any other one or more claims herein, wherein the one or more ultrasound arrays comprises two or more ultrasound arrays.

111. The system according to claim 110 and / or any other one or more claims herein, further comprising an electronic switch, wherein each ultrasound array is configured to be independently activated via the electronic switch.

112. The system according to claim 110 and / or any other one or more claims herein, wherein the treatment device comprises a shaft, and wherein at least two ultrasound arrays of the two or more ultrasound arrays are located on and / or within the shaft of the treatment device, the at least two arrays located in a sequential axial arrangement.

113. The system according to claim 112 and / or any other one or more claims herein, wherein the at least two ultrasound arrays are configured to produce the image data via rotation of the associated array.

114. The system according to claim 110 and / or any other one or more claims herein, wherein the two or more ultrasound arrays comprise a first ultrasound array and a second ultrasound array, and wherein the first ultrasound array is connected to the second ultrasound array via a hinge and / or other articulation element.

115. The system according to claim 114 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to change an angle between the first ultrasound array and the second ultrasound array via changing the hinge and / or other articulation element angle.

116. The system according to claim 109 and / or any other one or more claims herein, wherein a first ultrasound array of the one or more ultrasound arrays is connected to an articulation element configured to allow adjustable positioning of the first ultrasound array relative to a tissue surface.

117. The system according to claim 116 and / or any other one or more claims herein, wherein the articulation element comprises a ball joint, a hinge, or both.

118. The system according to claim 116 and / or any other one or more claims herein, wherein the tissue surface comprises uterine wall tissue, base of tongue tissue, and / or other tissue surface.

119. The system according to claim 109 and / or any other one or more claims herein, wherein a first ultrasound array of the one or more ultrasound arrays is connected to a first portion of a hinge and / or other articulation element.

120. The system according to claim 119 and / or any other one or more claims herein, wherein the treatment device comprises a shaft, and wherein a second portion of the articulation element is connected to the shaft.

121. The system according to claim 120 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to adjust the angle between the shaft and the first ultrasound array.

122. The system according to claim 119 and / or any other one or more claims herein, wherein the robotic manipulation assembly is connected to a second portion of the articulation element.

123. The system according to claim 119 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to positionthe at least one ultrasound array relative to a tissue surface based on a pressure signal.

124. The system according to claim 123 and / or any other one or more claims herein, wherein the tissue surface comprises the uterine wall, a fibroid surface, or both.

125. The system according to claim 109 and / or any other one or more claims herein, wherein the treatment assembly comprises a first ultrasound array of the one or more ultrasound arrays, and wherein the first ultrasound array is configured to perform the treatment procedure.

126. The system according to claim 125 and / or any other one or more claims herein, wherein the first ultrasound array is further configured to produce the image data.

127. The system according to claim 125 and / or any other one or more claims herein, wherein the ultrasound assembly comprises a second ultrasound array of the one or more ultrasound arrays, and wherein the second ultrasound array is configured to produce the image data.

128. The system according to claim 127 and / or any other one or more claims herein, wherein the second ultrasound array is further configured to perform the treatment procedure.

129. The system according to claim 127 and / or any other one or more claims herein, wherein the first ultrasound array is further configured to produce the image data.

130. The system according to claim 1 and / or any other one or more claims herein, wherein the robotic manipulation assembly comprises at least one robotically manipulatable arm.

131. The system according to claim 1 and / or any other one or more claims herein, wherein the robotic manipulation assembly comprises at least two robotically manipulatable arms.

132. The system according to claim 131 and / or any other one or more claims herein, wherein the at least two robotically manipulated arms comprise a first arm to travel along a first axis, and a second arm to travel along a second axis that is relatively orthogonal to the first axis.

133. The system according to claim 131 and / or any other one or more claims herein, further comprising a second imaging device, wherein a first robotically manipulatable arm is configured to be manipulated based on the image data produced by the ultrasound assembly, and wherein a second robotically manipulatable arm is configured to be manipulated based on image data produced by the second imaging device.

134. The system according to claim 1 and / or any other one or more claims herein, wherein the robotic manipulation assembly comprises at least three robotically manipulatable arms.

135. The system according to claim 1 and / or any other one or more claims herein, wherein the robotic manipulation assembly comprises at least one robotically manipulatable arm configured in a snake-robot arrangement.

136. The system according to claim 1 and / or any other one or more claims herein, wherein the robotic manipulation assembly comprises one or more control cables, and wherein translation of each control cable is configured to manipulate at least a portion of a first system component.

137. The system according to claim 136 and / or any other one or more claims herein, wherein translation of a first control cable is configured to manipulate a distal portion of the first system component.- no -138. The system according to claim 1 and / or any other one or more claims herein, wherein a first system component comprises one or more magnetic elements, and wherein the robotic manipulation assembly is configured to manipulate the system component by applying magnetic forces to the magnetic element.

139. The system according to claim 138 and / or any other one or more claims herein, wherein application of the magnetic forces is configured to manipulate a distal portion of the first system component.

140. The system according to claim 1 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to perform at least a 45 degree rotation of a first ultrasound array of the ultrasound assembly to increase the volume of target tissue ablated by the ultrasound assembly.

141. The system according to claim 140 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to perform at least a 180 degree rotation of the first ultrasound array of the ultrasound assembly to ablate a “full circle” of target tissue.

142. The system according to claim 141 and / or any other one or more claims herein, further comprising a substrate including a gel and having an umbrella geometry, wherein the substrate is positioned between the robotic manipulation assembly and the first ultrasound array.

143. The system according to claim 1 and / or any other one or more claims herein, further comprising a force measurement assembly configured to measure the force applied to a first component of the system, wherein the first component of the system is configured to be manipulated by the robotic manipulation assembly.

144. The system according to claim 143 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to maintain the force- I l l -applied to the first system component to a force below a threshold based on one or more measurements performed by the force measurement assembly.

145. The system according to claim 143 and / or any other one or more claims herein, wherein the first system component comprises the treatment assembly.

146. The system according to claim 143 and / or any other one or more claims herein, wherein the first system component comprises the ultrasound assembly.

147. The system according to claim 143 and / or any other one or more claims herein, wherein the force measurement assembly is further configured to measure the force applied to a second component of the system.

148. The system according to claim 143 and / or any other one or more claims herein, wherein the first component of the system comprises the ultrasound assembly, wherein the system is configured to determine clinically relevant force thresholds related to the current anatomical location of the ultrasound assembly, and wherein the robotic manipulation assembly is configured to robotically manipulate the ultrasound assembly while preventing the ultrasound assembly applying a force to tissue that exceeds the force thresholds for that tissue.

149. The system according to claim 1 and / or any other one or more claims herein, further comprising a tissue manipulating assembly configured to manipulate the target tissue and / or other tissue of the patient.

150. The system according to claim 149 and / or any other one or more claims herein, wherein the robotic manipulating assembly is configured to robotically manipulate the tissue manipulating assembly.

151. The system according to claim 149 and / or any other one or more claims herein, wherein the tissue manipulating assembly comprises one or more tissue manipulating elements.

152. The system according to claim 151 and / or any other one or more claims herein, wherein the one or more tissue manipulating elements comprise an element selected from the group consisting of: a balloon; an expandable cage; an unfurlable element; an expandable element; and combinations thereof.

153. The system according to claim 151 and / or any other one or more claims herein, wherein the one or more tissue manipulating elements comprise a first tissue manipulating element located in the treatment device.

154. The system according to claim 149 and / or any other one or more claims herein, wherein the tissue manipulating assembly is configured to cause the treatment device to safely move along the uterine wall.

155. The system according to claim 154 and / or any other one or more claims herein, wherein the treatment device comprises a shaft and wherein a first tissue manipulating element comprises a balloon positioned on the shaft, wherein the balloon is configured to contact the uterine wall.

156. The system according to claim 1 and / or any other one or more claims herein, further comprising a localization assembly comprising one or more localization elements, wherein the localization assembly is configured to produce anatomical location data related to the anatomical location of a first system component to be localized.

157. The system according to claim 156 and / or any other one or more claims herein, wherein the robotic manipulation assembly is further configured to robotically manipulate the localization assembly.

158. The system according to claim 156 and / or any other one or more claims herein, wherein the one or more localization elements comprise one or more magnetic markers.

159. The system according to claim 158 and / or any other one or more claims herein, wherein the localization assembly is configured to determine the orientation of the first system component with at least 6 degrees of freedom.

160. The system according to claim 158 and / or any other one or more claims herein, wherein the one or more magnetic markers comprise orthogonal coils.

161. The system according to claim 160 and / or any other one or more claims herein, wherein the localization assembly is configured to determine roll, pitch, and yaw of the first system component.

162. The system according to claim 156 and / or any other one or more claims herein, wherein the one or more localization elements comprise one or more visualizable markers.

163. The system according to claim 162 and / or any other one or more claims herein, wherein the one or more visualizable markers comprise one, two, or more markers selected from the group consisting of radiopaque markers; ultrasonically visible markers; electromagnetic markers; and combinations thereof.

164. The system according to claim 156 and / or any other one or more claims herein, wherein the one or more localization elements comprise one or more electrically conductive markers.

165. The system according to claim 156 and / or any other one or more claims herein, wherein the localization assembly is configured to provide 2D anatomical location information, 3D anatomical location information, or both.

166. The system according to claim 156 and / or any other one or more claims herein, wherein the localization assembly is configured to provide anatomical locationinformation of the treatment assembly and / or another portion of the treatment device.

167. The system according to claim 166 and / or any other one or more claims herein, wherein the localization assembly is further configured to provide anatomical location information of an additional component of the system.

168. The system according to claim 166 and / or any other one or more claims herein, wherein the localization assembly is further configured to provide anatomical location information of the ultrasound assembly.

169. The system according to claim 168 and / or any other one or more claims herein, further comprising an insertable probe, wherein the insertable probe comprises the ultrasound assembly.

170. The system according to claim 156 and / or any other one or more claims herein, wherein the localization assembly is configured to produce anatomical location information further based on the image data.

171. The system according to claim 156 and / or any other one or more claims herein, wherein the system is configured to produce an image of the patient anatomy and the localized first system component in a registered arrangement.

172. The system according to claim 1 and / or any other one or more claims herein, wherein the system is further configured to cause the robotic manipulating assembly to perform the robotic manipulation further based on the anatomical location information produced by the localization assembly.

173. The system according to claim 1 and / or any other one or more claims herein, further comprising an ablation assessment assembly configured to: produce data related to the ablation of the target tissue and / or other tissue; predict quality of a future ablation; or both.

174. The system according to claim 173 and / or any other one or more claims herein, wherein the robotic manipulation assembly is further configured to robotically manipulate the ablation assessment assembly.

175. The system according to claim 173 and / or any other one or more claims herein, wherein the system is configured to prevent a tissue treatment if a prediction of the ablation assessment assembly is below a threshold.

176. The system according to claim 1 and / or any other one or more claims herein, further comprising a controller and a memory storage component coupled to the controller, wherein the memory storage component stores instructions to perform an algorithm.

177. The system according to claim 176 and / or any other one or more claims herein, wherein the algorithm comprises an artificial intelligence (Al) algorithm.

178. The system according to claim 176 and / or any other one or more claims herein, wherein the algorithm is configured to produce an anatomical model based on at least the image data.

179. The system according to claim 178 and / or any other one or more claims herein, wherein the anatomical model comprises two or more sets of 3D images that are stitched together.

180. The system according to claim 178 and / or any other one or more claims herein, wherein the anatomical model is based on one or more landmarks identified in the image data.

181. The system according to claim 178 and / or any other one or more claims herein, wherein the algorithm is further configured to identify one or more features of interest in the anatomical model.

182. The system according to claim 181 and / or any other one or more claims herein, wherein the one or more features of interest compriseone or more features selected from the group consisting of: fibroid tissue; tumor tissue; margin tissue; blood vessel; duct; target tissue; safety margin tissue; non-target tissue; and combinations thereof.

183. The system according to claim 181 and / or any other one or more claims herein, wherein the algorithm is further configured to automatically perform the robotic manipulation based on the anatomical model and the one or more features of interest.

184. The system according to claim 181 and / or any other one or more claims herein, wherein the algorithm is further configured to prevent a manual robotic manipulation based on the anatomical model and the one or more features of interest.

185. The system according to claim 181 and / or any other one or more claims herein, wherein the algorithm is further configured to prevent a delivery of energy based on the anatomical model and one or more features of interest.

186. The system according to claim 178 and / or any other one or more claims herein, wherein the algorithm is further configured to prevent a delivery of energy based on a current position and / or orientation of an energy delivery component relative to target tissue and / or the current position and / or orientation of the energy delivery component relative to non-target tissue.

187. The system according to claim 178 and / or any other one or more claims herein, wherein the algorithm is further configured to prevent a delivery of energy based on image data that comprises blood flow information.

188. The system according to claim 187 and / or any other one or more claims herein, wherein the ultrasound assembly is configured to provide the image data comprising the blood flow information, andwherein the blood flow information comprises doppler blood flow information.

189. The system according to claim 178 and / or any other one or more claims herein, wherein the algorithm is further configured to identify non-target tissue in the anatomical model, and wherein the system is configured to limit energy delivery to the non-target tissue using the anatomical model.

190. The system according to claim 189 and / or any other one or more claims herein, wherein the non-target tissue comprises: blood vessel tissue; tissue proximate a blood vessel; nerve tissue; and / or tissue proximate a nerve.

191. The system according to claim 178 and / or any other one or more claims herein, wherein the algorithm is further configured to identify a blood vessel proximate to the target tissue.

192. The system according to claim 191 and / or any other one or more claims herein, wherein the system is configured to ablate the blood vessel that is proximate the target tissue.

193. The system according to claim 178 and / or any other one or more claims herein, wherein the algorithm is configured to compensate for tissue movement when creating the anatomical model.

194. The system according to claim 193 and / or any other one or more claims herein, wherein the image data comprises image data collected prior to the occurrence of the tissue movement.

195. The system according to claim 193 and / or any other one or more claims herein, wherein the algorithm is further configured to adjust the trajectory of a system component based on an assessment of the tissue movement.

196. The system according to claim 178 and / or any other one or more claims herein, wherein the algorithm is further configured to predict patient movement and / or other tissue movement.

197. The system according to claim 178 and / or any other one or more claims herein, further comprising a second imaging device, wherein the algorithm is further configured to create the image data by combining first image data received from the ultrasound assembly and second image data received from the second imaging device.

198. The system according to claim 197 and / or any other one or more claims herein, wherein the second imaging device comprises an MRI.

199. The system according to claim 178 and / or any other one or more claims herein, wherein the anatomical model comprises a 3D model comprising a high-resolution portion and one or more low-resolution portions.

200. The system according to claim 199 and / or any other one or more claims herein, wherein the system is configured to gather additional data and to transform at least one low-resolution portion of the 3D model to a portion with increased resolution.

201. The system according to claim 200 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to robotically manipulate the ultrasound assembly and / or another system component to gather the additional data.

202. The system according to claim 199 and / or any other one or more claims herein, wherein the system comprises a library of anatomical model templates, and wherein the algorithm is configured to produce the anatomical model based on one or more of the anatomical templates and on the image data.

203. The system according to claim 199 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to automatically manipulate the treatment device based on the anatomical model.

204. The system according to claim 203 and / or any other one or more claims herein, wherein the automatic manipulation is further based on location of target tissue.

205. The system according to claim 203 and / or any other one or more claims herein, wherein the automatic manipulation is further based on a pre-determined trajectory map configured to optimize image data collection.

206. The system according to claim 205 and / or any other one or more claims herein, wherein the algorithm comprises an artificial intelligence algorithm configured to determine the pre-determined trajectory map.

207. The system according to claim 203 and / or any other one or more claims herein, wherein the algorithm comprises an artificial intelligence algorithm configured to determine a sequence of treatment locations.

208. The system according to claim 178 and / or any other one or more claims herein, wherein the algorithm is configured to produce the anatomical model based on properties of one or more materials in the acoustic pathway of the ultrasound assembly when producing the image data.

209. The system according to claim 178 and / or any other one or more claims herein, wherein the algorithm is further configured to cause the roboticmanipulation assembly to cause a system component to navigate within a portion of the patient’s anatomy included in the anatomical model.

210. The system according to claim 209 and / or any other one or more claims herein, wherein the system component comprises the ultrasound assembly, the treatment device, and / or another system component configured to treat the target tissue.

211. The system according to claim 178 and / or any other one or more claims herein, wherein the algorithm is configured to stitch and / or otherwise combine multiple images and / or multiple sets of image data to create the anatomical model.

212. The system according to claim 178 and / or any other one or more claims herein, wherein the algorithm comprises an artificial intelligence algorithm that is configured to identify one or more volumes of target tissue to be ablated, stimulated, and / or otherwise treated by the system.

213. The system according to claim 212 and / or any other one or more claims herein, wherein the one or more volumes of target tissue comprise: one or more fibroids; one or more volumes of tongue tissue; one or more volumes of soft palate tissue; one or more volumes of tonsil tissue; and / or one or more volumes of tumor tissue, such as one or more volumes of tumor tissue positioned behind a bone.

214. The system according to claim 178 and / or any other one or more claims herein, wherein the system is configured to gather second image data from an MRI, and wherein the algorithm is further configured to produce the anatomical model based on the second image data.

215. The system according to claim 214 and / or any other one or more claims herein, wherein the target tissue comprises: one or more fibroids; one or more volumes of tongue tissue; one or more volumesof soft palate tissue; one or more volumes of tonsil tissue; and / or one or more volumes of tumor tissue, such as one or more volumes of tumor tissue positioned behind a bone.

216. The system according to claim 176 and / or any other one or more claims herein, wherein the algorithm is configured to determine a desired change in a field of view of a first ultrasound array of the ultrasound assembly, and wherein the system is configured to perform an electronic focus adjustment of the ultrasound assembly; translate and / or rotate the first ultrasound array; or both.

217. The system according to claim 176 and / or any other one or more claims herein, further comprising at least one pressure sensor and / or other sensor, wherein each sensor is configured to produce a sensor signal, wherein the algorithm is configured to determine a force applied to a tissue surface by a first ultrasound array of the ultrasound assembly, the force determination based on: the sensor signals; the image data; or both.

218. The system according to claim 217 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to reposition the first ultrasound array if the applied force exceeds a threshold.

219. The system according to claim 176 and / or any other one or more claims herein, wherein the algorithm is configured to modify the field of view of an ultrasound array of the ultrasound assembly based on patient movement detected by the algorithm.

220. The system according to claim 219 and / or any other one or more claims herein, wherein the algorithm is configured to detect the patient movement by analyzing the image data.

221. The system according to claim 219 and / or any other one or more claims herein, further comprising one or more pressure sensors configured toproduce a pressure signal, wherein the algorithm is configured to detect patient movement by analyzing the pressure signal.

222. The system according to claim 176 and / or any other one or more claims herein, wherein the target tissue comprises a first volume of tissue, and wherein the algorithm is configured to determine if the field of view of a first ultrasound array is sufficient to treat the first volume of tissue in its entirety.

223. The system according to claim 222 and / or any other one or more claims herein, wherein if the algorithm determines the field of view of the first ultrasound array is insufficient to treat the first volume of tissue in its entirety, the algorithm is further configured to cause the robotic manipulation assembly to translate and / or rotate the first ultrasound array to change the field of view to treat the first volume of tissue in its entirety.

224. The system according to claim 176 and / or any other one or more claims herein, wherein the target tissue comprises a first volume of tissue, and wherein the algorithm is configured to minimize movement of the ultrasound assembly in treating the first volume of tissue in its entirety.

225. The system according to claim 176 and / or any other one or more claims herein, wherein the target tissue comprises multiple volumes of target tissue, and wherein the algorithm is configured to analyze the image data and based on the analysis cause the robotic manipulation assembly to robotically manipulate an energy delivery component along a trajectory to treat the multiple volumes of target tissue.

226. The system according to claim 225 and / or any other one or more claims herein, wherein the system is configured to gather additional image data during the robotic manipulation of the energy delivery component, and wherein the algorithm is configured to adjust the trajectory based on an analysis of the additional image data.

227. The system according to claim 226 and / or any other one or more claims herein, wherein the additional image data comprises data of lower resolution and / or higher resolution than the resolution of the image data.

228. The system according to claim 176 and / or any other one or more claims herein, wherein the algorithm comprises a bias.

229. The system according to claim 228 and / or any other one or more claims herein, wherein the algorithm is configured to determine a trajectory map used by the robotic manipulation assembly to robotically manipulate a system component, and wherein the algorithm is configured to bias one or more trajectories of the trajectory map toward one or more tissue types and / or away from one or more tissue types and / or one or more anatomical locations.

230. The system according to claim 1 and / or any other one or more claims herein, further comprising a processing unit comprising at least one processor, wherein the processing unit is operatively connected to the robotic manipulation assembly and is configured to control the robotic manipulation assembly to provide a treatment procedure to the patient according to a treatment plan that includes treating multiple volumes of tissue within a target tissue volume.

231. The system according to claim 230 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to provide the treatment procedure by: controlling the robotic manipulation assembly to mechanically position a first field of view of the ultrasound assembly within a first of the multiple volumes of tissue to be treated; delivering ultrasound energy with the ultrasound assembly to treat the first volume of tissue;controlling the robotic manipulation assembly to mechanically position a second field of view of the ultrasound assembly within a second of the multiple volumes of tissue to be treated; and delivering ultrasound energy with the ultrasound assembly to treat the second volume of tissue.

232. The system according to claim 230 and / or any other one or more claims herein, wherein the treatment plan is based on the image data.

233. The system according to claim 232 and / or any other one or more claims herein, wherein the image data comprises at least doppler ultrasound data.

234. The system according to claim 1 and / or any other one or more claims herein, further comprising a functional element comprising one or more sensors, one or more transducers, and / or one or more other functional elements.

235. The system according to claim 234 and / or any other one or more claims herein, wherein the robotic manipulation assembly is further configured to robotically manipulate the functional element.

236. The system according to claim 234 and / or any other one or more claims herein, wherein the functional element comprises a tissue manipulating element.

237. The system according to claim 236 and / or any other one or more claims herein, wherein the tissue manipulating element comprises a balloon.

238. The system according to claim 234 and / or any other one or more claims herein, wherein the functional element comprises one or more optical fibers configured to provide the treatment device and / or other system component geometry data and / or treatment device and / or other system component orientation data.

239. The system according to claim 238 and / or any other one or more claims herein, wherein the treatment device comprises the one or more optical fibers.

240. The system according to claim 238 and / or any other one or more claims herein, wherein the one or more optical fibers are configured to provide: 3D dimensional coordinate data; roll data; pitch data; and / or yaw data.

241. The system according to claim 1 and / or any other one or more claims herein, further comprising a user interface configured to provide information to a user and / or receive information from a user.

242. The system according to claim 241 and / or any other one or more claims herein, wherein the user interface comprises a component selected from the group consisting of user input device; user output device; display; touchscreen; button; switch; lever; footswitch; user-mountable assembly; head-mountable assembly; and combinations thereof.

243. The system according to claim 241 and / or any other one or more claims herein, wherein the user interface comprises a user-mountable assembly configured to attach to a first user, and wherein the user-mountable assembly is configured to provide information to the first user and / or receive information from the first user.

244. The system according to claim 243 and / or any other one or more claims herein, wherein the user-mountable assembly is configured to mount to the head of the first user.

245. The system according to claim 243 and / or any other one or more claims herein, wherein the user-mountable assembly is configured to track movement of the first user.

246. The system according to claim 245 and / or any other one or more claims herein, wherein the system is configured to correlate the movement to a gesture, and wherein the gesture is assigned to a first function of the system.

247. The system according to claim 246 and / or any other one or more claims herein, wherein the correlation of the gesture is further based on input from an additional user input component of the system.

248. The system according to claim 246 and / or any other one or more claims herein, wherein the first function comprises a movement of the robotic manipulation assembly.

249. The system according to claim 246 and / or any other one or more claims herein, wherein the first function comprises creation of an image.

250. The system according to claim 246 and / or any other one or more claims herein, wherein the first function comprises delivery of energy.

251. The system according to claim 241 and / or any other one or more claims herein, wherein the user interface includes a user feedback component configured to provide alert information and / or other information to an operator of the system.

252. The system according to claim 251 and / or any other one or more claims herein, wherein the alert information and / or other information comprises haptic feedback, audible feedback, or both.

253. The system according to claim 252 and / or any other one or more claims herein, wherein the alert information and / or other informationcomprises information related to temperature of target tissue, temperature of non-target tissue, or both.

254. The system according to claim 251 and / or any other one or more claims herein, wherein the alert information and / or other information comprises information related to positioning of an energy delivery component of the system relative to: target tissue, non-target tissue, or both.

255. The system according to claim 251 and / or any other one or more claims herein, wherein the feedback provided comprises visual feedback comprising images of the patient’s anatomy and / or images of one or more system components such as images indicating the position of one or more system components relative to target tissue and / or relative to non-target tissue.

256. The system according to claim 251 and / or any other one or more claims herein, wherein the alert information and / or other information comprises information related to the level of ablation of target tissue.

257. The system according to claim 1 and / or any other one or more claims herein, further comprising a console configured to operably attach to the treatment device, the robotic manipulation assembly, or both.

258. The system according to claim 257 and / or any other one or more claims herein, wherein the console comprises an ultrasound module for providing drive signals to the ultrasound assembly.

259. The system according to claim 1 and / or any other one or more claims herein, further comprising a sensor comprising an assembly of one or more sensors, wherein each sensor is configured to provide a sensor signal.

260. The system according to claim 259 and / or any other one or more claims herein, wherein the robotic manipulation assembly is further configured to robotically manipulate the sensor.

261. The system according to claim 259 and / or any other one or more claims herein, wherein the treatment device comprises the sensor.

262. The system according to claim 259 and / or any other one or more claims herein, wherein the ultrasound assembly comprises the sensor.

263. The system according to claim 262 and / or any other one or more claims herein, wherein the sensor comprises at least one pressure sensor.

264. The system according to claim 263 and / or any other one or more claims herein, wherein the at least one pressure sensor comprises at least four pressure sensors.

265. The system according to claim 263 and / or any other one or more claims herein, wherein based on the sensor signal from each pressure sensor, the robotic manipulation assembly and / or other system component is configured to: maintain proper contact with tissue, such as to reduce presence of air bubbles between the ultrasound assembly and tissue; prevent undesired force being applied to tissue by an operator and / or the robotic manipulation assembly; or both.

266. The system according to claim 259 and / or any other one or more claims herein, wherein the sensor comprises one or more thermocouples, infrared cameras, and / or other temperature sensors.

267. The system according to claim 259 and / or any other one or more claims herein, wherein the sensor comprises one or more pressure sensors.

268. The system according to claim 1 and / or any other one or more claims herein, further comprising a surgical tissue treatment tool configured to treat tissue of the patient.

269. The system according to claim 268 and / or any other one or more claims herein, wherein the robotic manipulation assembly is further configured to robotically manipulate the surgical tissue treatment tool.

270. The system according to claim 268 and / or any other one or more claims herein, wherein the surgical tissue treatment tool is configured to treat tissue via a delivery of energy comprising energy in a form selected from the group consisting of: radiofrequency energy, microwave energy, and / or other electromagnetic energy; laser energy and / or other light energy; thermal energy, such as hot fluid energy and / or cryogenic energy; ultrasound energy; mechanical energy; chemical energy; and combinations thereof.

271. The system according to claim 268 and / or any other one or more claims herein, wherein the treatment device comprises the surgical tissue treatment tool, and wherein the surgical tissue treatment tool is configured to deliver energy to perform the treatment of the target tissue.

272. The system according to claim 268 and / or any other one or more claims herein, wherein the image data is used to create a trajectory map for the surgical tissue treatment tool.

273. The system according to claim 272 and / or any other one or more claims herein, wherein the trajectory map comprises and / or is based on information selected from the group consisting of: target tissue location information; non-target tissue location information; trajectory depthinformation; ablation depth information; margin information; blood vessel location information; and combinations thereof.

274. The system according to claim 268 and / or any other one or more claims herein, wherein the surgical tissue treatment tool is configured to treat a first volume of target tissue, and the ultrasound assembly is configured to treat a second volume of the target tissue.

275. The system according to claim 274 and / or any other one or more claims herein, wherein the first volume of target tissue is a larger tissue volume than the second volume of target tissue.

276. The system according to claim 274 and / or any other one or more claims herein, wherein the first volume of target tissue comprises at least 50% of the volume of a fibroid, and wherein the second volume of target tissue comprises one or more margins of a fibroid.

277. The system according to claim 274 and / or any other one or more claims herein, wherein the second volume of target tissue comprises a non- vascular volume of tissue.

278. The system according to claim 274 and / or any other one or more claims herein, wherein the ultrasound assembly is configured to treat one or more other volumes of target tissue, and wherein each of the other volumes of target tissue is less than the first volume of target tissue.

279. The system according to claim 268 and / or any other one or more claims herein, wherein the ultrasound assembly is configured to perform a cauterization.

280. The system according to claim 279 and / or any other one or more claims herein, wherein the surgical tissue treatment tool comprises a radiofrequency delivery needle and / or other needle, and wherein thecauterization performed by the ultrasound assembly cauterizes a puncture tract of the radiofrequency delivery needle and / or other needle.

281. The system according to claim 268 and / or any other one or more claims herein, wherein the ultrasound assembly is configured to deliver a plane of high intensity focused ultrasound energy that marks a boundary in tissue, and wherein the surgical tissue treatment tool treats a volume of target tissue based on the marked boundary.

282. The system according to claim 281 and / or any other one or more claims herein, wherein the plane of high intensity focused ultrasound energy is configured to ablate margin tissue of the target tissue.

283. The system according to claim 1 and / or any other one or more claims herein, further comprising a body introduction device configured to aid in delivery of a system component to a location within the body of the patient.

284. The system according to claim 283 and / or any other one or more claims herein, wherein the robotic manipulation assembly is configured to robotically manipulate the body introduction device.

285. The system according to claim 283 and / or any other one or more claims herein, wherein the body introduction device comprises a device selected from the group consisting of: sheath; trocar; vascular introducer; laparoscopic port; endoscope; and combinations thereof.

286. The system according to claim 283 and / or any other one or more claims herein, wherein the treatment device is configured to be slidingly inserted through the body introduction device and into the patient.

287. The system according to claim 1 and / or any other one or more claims herein, further comprising an augmented reality device.

288. The system according to claim 287 and / or any other one or more claims herein, wherein the augmented reality device is configured to provide images and / or other information to an operator in an augmented reality arrangement, such as images and / or other information that is based on the image data and / or other data produced by the system.

289. The system according to claim 1 and / or any other one or more claims herein, further comprising a second imaging device comprising one or more imaging devices configured to produce additional image data.

290. The system according to claim 289 and / or any other one or more claims herein, wherein the robotic manipulation assembly is further configured to robotically manipulate the second image device.

291. The system according to claim 289 and / or any other one or more claims herein, wherein the treatment device comprises the second imaging device.

292. The system according to claim 289 and / or any other one or more claims herein, wherein the second imaging device comprises one, two, or more devices selected from the group consisting of fluoroscope or other X-ray imaging device; CT scanner; MRI; PET scanner; ultrasound imager; OCT and / or other light-based imaging device; and combinations thereof.

293. The system according to claim 289 and / or any other one or more claims herein, wherein the second imaging device comprises an MRI configured to identify target tissue for treatment.

294. The system according to claim 293 and / or any other one or more claims herein, wherein the target tissue comprises one or more fibroids.

295. The system according to claim 289 and / or any other one or more claims herein, wherein the second imaging device comprises an optical fiber.

296. The system according to claim 295 and / or any other one or more claims herein, wherein the treatment device comprises the optical fiber.

297. The system according to claim 295 and / or any other one or more claims herein, wherein the image data comprises photoacoustic image data.

298. The system according to claim 297 and / or any other one or more claims herein, wherein the image data comprises data representing the presence of blood vessels.

299. The system according to claim 1 and / or any other one or more claims herein, further comprising an agent, wherein the agent comprises one or more agents configured to be delivered to the patient.

300. The system according to claim 299 and / or any other one or more claims herein, wherein the system further comprises a delivery element configured to deliver the agent to the patient, and wherein the robotic manipulation assembly is further configured to robotically manipulate the delivery element.

301. The system according to claim 1 and / or any other one or more claims herein, further comprising a cooling device configured to: cool tissue of the patient; cool a system component; or both.

302. The system according to claim 301 and / or any other one or more claims herein, wherein the cooling device comprises a cooling element, and wherein the robotic manipulation assembly is further configured to robotically manipulate the cooling element.

303. The system according to claim 1 and / or any one or more other claims herein, further comprising a light source and a light delivery element,wherein the system is configured to produce a first set of image data via:(1) delivery of ultrasound and receiving of reflections of that delivered ultrasound; and(2) the delivery of pulsed light and the receiving of ultrasound that results from the delivery of the pulsed light.

304. The system according to claim 303 and / or any one or more other claims herein, wherein the robotic manipulation assembly manipulates the treatment device based on the first set of image data305. The system according to claim 1 and / or any one or more other claims herein, further comprising an algorithm that is configured to cause the robotic manipulation assembly to orient the treatment assembly away from locations in which energy is delivered to non-target tissue306. The system according to claim 1 and / or any one or more other claims herein, where the treatment assembly is configured to deliver focused ultrasound energy configured to perform a histotripsy procedure on target tissue.

307. The system according to claim 1 and / or any one or more other claims herein, further comprising an agent comprising one, two, or more tissue markers.

308. The system according to claim 307 and / or any one or more other claims herein, wherein the agent comprises one, two, or more tissue markers selected from the group consisting of: photoacoustic tags; ultrasonically- reflective markers; visualizable markers; magnetic markers; and combinations thereof.

309. The system according to claim 307 and / or any one or more other claims herein, wherein the robotic manipulation assembly is configured torobotically manipulate a system component based on image data including the location of the one, two, or more tissue markers.

310. The system according to claim 1 and / or any one or more other claims herein, wherein the robotic manipulation assembly comprises a robotically-manipulatable arm that is coupled to a shaft of the treatment device through a controllable hinge, and wherein the treatment device comprises an ultrasound array comprising the set of one or more ultrasound transducers.

311. The system according to claim 310 and / or any other one or more claims herein, the controllable hinge is configured to vary the angle between the robotically-manipulatable arm and the shaft of the treatment device to orient the ultrasound array toward target tissue.

312. The system according to claim 310 and / or any other one or more claims herein, wherein the controllable hinge is configured to constrain the contact force between the treatment device and the tissue to remain between minimum-force and / or maximum-force thresholds.

313. The system according to claim 310 and / or any other one or more claims herein, wherein the ultrasound array is mounted on a flexible substrate and is operatively connected to a control cable that is actuated by the robotic manipulation assembly to transition the array between a linear geometry and a curvilinear geometry.

314. The system of claim 1, wherein the robotic manipulation assembly comprises at least three independently controllable robotically-manipulatable arms, each arm operably attached to a respective treatment device that includes an ultrasound assembly.

315. The system according to claim 314 and / or any other one or more claims herein, wherein the system is further configured to generate image data withan ultrasound assembly on a first arm and to robotically manipulate at least one other arm based on that image data.

316. A method of performing a medical procedure on a patient, comprising: selecting a system of any of claims 1 through 302; producing image data using at least the ultrasound array; and treating target tissue of the patient by robotically manipulating a component of the system using the produced image data.

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