WO2025179117A1

WO2025179117A1 - Ultrasound system

Info

Publication number: WO2025179117A1
Application number: PCT/US2025/016752
Authority: WO
Inventors: Butrus T. Khuri-Yakub; Arif Sanli Ergun; Paul CRISTMAN; George Quintin STEDMAN; Guillaume David; Gerard Touma; Yichi Zhang; Veijo Tapani SUORSA; R. Maxwell Flaherty; J. Christopher Flaherty
Original assignee: Orchard Ultrasound Innovation LLC
Current assignee: Orchard Ultrasound Innovation LLC
Priority date: 2024-02-21
Filing date: 2025-02-21
Publication date: 2025-08-28
Anticipated expiration: 2026-08-21

Abstract

Provided are systems, methods and devices for performing a medical procedure using an array of ultrasound transducers. A system can include an ultrasound device having an ultrasound array including one or more ultrasound transducers. The ultrasound array can emit ultrasound to target tissue of the patient.

Description

ULTRASOUND SYSTEM

RELATED APPLICATIONS

[001] This application claims the benefit of 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.

[002] This application claims the benefit of 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.

[003] 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.

[004] 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.

[005] 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.

[006] 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.

[007] 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.

[008] 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.

[009] 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.

[010] 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.

[011] 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.

[012] 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, 2022, the content of which is incorporated by reference in its entirety for all purposes.

[013] 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, 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.

[014] 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.

[015] 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.

[016] 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.

[017] 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.

[018] 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.

[019] This application is related to 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. FIELD OF THE INVENTIVE CONCEPTS

[020] The present inventive concepts relate generally to systems, devices, and methods for performing a medical procedure on a patient, particularly systems that deliver ultrasound energy to perform a diagnostic and/or therapeutic procedure on the patient.

BACKGROUND

[021] Numerous medical devices involve the transmission of energy into the patient in order to collect image data or treat tissue. There is a need for improved systems, devices, and methods for transmitting energy to diagnose or treat diseases and disorders of patients.

SUMMARY

[022] According to an aspect of the present inventive concepts, a system for performing a medical procedure on a patient comprises an ultrasound device comprising an ultrasound array including one or more ultrasound transducers. The ultrasound array can be configured to emit ultrasound to target tissue of the patient. The system can be configured to operate the ultrasound array with a fractional bandwidth in the range of 65% to 100% (e.g., at least 65%, no more than 100%, or both), and with a ratio of maximum plate displacement to median plate displacement of no more than 150%. Alternatively, or additionally, the system can be configured to: during delivery of treatment energy, operate the ultrasound array within a frequency range that is 80% to 100% (e.g., at least 80%, no more than 100%, or both) of the center frequency of the one or more ultrasound transducers, and during delivery of energy to produce image data, operate the ultrasound array within a frequency range that is 80% to 160% (e.g., at least 80%, no more than 160%, or both) of the center frequency of the one or more ultrasound transducers.

[023] In some embodiments, during the delivery of energy to produce image data, the system is configured to perform harmonic imaging with a transmit frequency of approximately 4MHz and a receive frequency of approximately 8MHz.

[024] In some embodiments, the system is configured to operate the ultrasound array with a ratio of maximum plate displacement to median plate displacement of no more than 150%.

[025] In some embodiments, the ultrasound array is configured to produce a surface pressure of at least IMPa peak-to-peak for a time period of at least 15 minutes, 20 minutes, or 30 minutes. The ultrasound array can be operated at a frequency of at least 3 MHz, of no more than 7MHz, or both. The ultrasound array can be operated with an AC + DC transmit voltage of no more than 220V. The ultrasound array can be operated with a fractional bandwidth of at least 65%.

[026] In some embodiments, the medical procedure comprises a diagnostic procedure. The diagnostic procedure can comprise an imaging and/or other diagnostic analysis of the prostate of the patient. The diagnostic procedure can comprise an imaging and/or other diagnostic analysis of an anatomical location of the patient selected from the group consisting of prostate; uterus; nasal passageway and/or tongue; an organ such as bladder, bone, brain, heart, intestine, kidney, liver, lung, skin, and/or stomach; and combinations thereof. The diagnostic procedure can comprise an imaging and/or other diagnostic analysis of a tissue type selected from the group consisting of benign prostatic hyperplasia tissue; tumor 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 thereof.

[027] In some embodiments, the medical procedure comprises a treatment procedure. The treatment procedure can comprise ablation, stimulation, and/or other treatment of the target tissue, and the target tissue can comprise tissue of the prostate of the patient. The system can be configured to avoid damage to non-target tissue of the patient. The non-target tissue can comprise: tissue of the wall of the urethra, tissue of a seminal vesicle, and/or tissue of the ejaculatory duct. The treatment procedure can comprise ablation, stimulation, and/or other treatment of the target tissue, and the target tissue can comprise tissue of an anatomical location selected from the group consisting of: prostate; uterus; nasal passageway and/or tongue (e.g., to treat sleep apnea); an organ such as bladder, bone, brain, heart, intestine, kidney, liver, lung, skin, and/or stomach; and combinations thereof. The treatment procedure can comprise ablation, stimulation, and/or other treatment of the target tissue, and the target tissue can comprise a tissue type selected from the group consisting of: benign prostatic hyperplasia tissue; tumor tissue; tissue associated with a cardiac arrhythmia; tissue associated with sleep apnea and/or blockage of an airway; other abnormal and/or otherwise undesired tissue; and combinations thereof. The treatment procedure can comprise the delivery of ultrasound energy to activate a pharmaceutical and/or other agent; and/or to enhance the efficacy of a pharmaceutical and/or other agent. [028] In some embodiments, the system is configured to perform a medical procedure comprising the delivery of ultrasound energy to an implant and/or an agent, such as to supply power to and/or otherwise modify the implant and/or agent.

[029] In some embodiments, the medical procedure comprises a diagnostic procedure and a treatment procedure. The medical procedure can comprise diagnosis and treatment of the prostate of the patient. The treatment procedure can comprise ablation, stimulation, and/or other treatment of the target tissue, and the target tissue can comprise tissue of an anatomical location selected from the group consisting of: prostate; uterus; nasal passageway and/or tongue (e.g., to treat sleep apnea); an organ such as bladder, bone, brain, heart, intestine, kidney, liver, lung, skin, and/or stomach; and combinations thereof. The treatment procedure can comprise ablation, stimulation, and/or other treatment of the target tissue. The treatment procedure can comprise an ultrasound-enhance localized drug delivery procedure. The target tissue can comprise a tissue type selected from the group consisting of: benign prostatic hyperplasia tissue; tumor tissue; tissue associated with a cardiac arrhythmia; tissue associated with sleep apnea and/or blockage of an airway; other abnormal and/or otherwise undesired tissue; and combinations thereof. The medical procedure can comprise both imaging and treating. The imaging and treating can be performed simultaneously, sequentially, or both. The imaging can be configured to produce image data, and the treating can be performed based on one or more treatment parameters that can be determined based on the produced image data. The one or more treatment parameters can be determined by the system.

[030] In some embodiments, the target tissue comprises tissue of the prostate of the patient.

[031] In some embodiments, the target tissue comprises tissue at an anatomical location selected from the group consisting of: prostate; uterus; nasal passageway and/or tongue; an organ such as bladder, bone, brain, heart, intestine, kidney, liver, lung, skin, and/or stomach; and combinations thereof.

[032] In some embodiments, the target tissue comprises tissue with a tissue type selected from the group consisting of: benign prostatic hyperplasia tissue; tumor tissue; tissue associated with a cardiac arrhythmia; tissue associated with sleep apnea and/or blockage of an airway; other abnormal and/or otherwise undesired tissue; and combinations thereof.

[033] In some embodiments, the system is configured to perform a system diagnostic procedure, such as a diagnostic procedure in which functionality of the one or more ultrasound transducers is assessed. The ultrasound device can comprise a wall (e.g., an outer wall), and the assessment can be based on a reflection of ultrasound received from the wall.

[034] In some embodiments, the system is configured to determine an angle of orientation of the ultrasound array relative to a portion of the ultrasound device. The ultrasound device can comprise a wall (e g., an outer wall), and the angle of orientation can be determined based on a reflection of ultrasound received from the wall. The system can be configured to produce a 3D image, and the 3D image can be enhanced based on the determined angle of orientation.

[035] In some embodiments, the ultrasound device comprises a distal portion, and the system is constructed and arranged to allow an operator to perform an insertion procedure in which the distal portion of the ultrasound device is inserted into the patient by an operator, and the ultrasound array is positioned a desired distance from the target tissue when the insertion procedure is completed. The system can be configured to produce one or more images of tissue of the patient prior to completion of the insertion procedure, and the ultrasound array can be positioned at the desired distance based on the one or more images.

[036] In some embodiments, the system is configured to produce one or more multidimensional images of tissue, and each multi-dimensional image comprises at least a partial circumferential image of tissue, and the partial circumferential image represents a sector of tissue of at least 180°. The system can be configured to create the one or more multi-dimensional images via manual rotation of the ultrasound device by an operator. The sector can comprise a sector of at least 350°. The system can be configured to analyze the one or more multidimensional images and produce at least tissue volume information. The system can be configured to perform diagnostics and/or therapy planning based on the one or more multidimensional images. The one or more multi-dimensional images can comprise images of the majority of the patient’s prostate, and the multi-dimensional images can be based on ultrasound reflections received while the ultrasound array can be positioned within the prostatic urethra. The ultrasound device can comprise one or more flexible segments configured to reduce forces encountered during translation within the prostatic urethra or other patient conduit, and the ultrasound device can comprise one or more components comprising sufficient torsional strength to allow smooth rotation of the ultrasound array within the prostatic urethra or other patient conduit. The ultrasound array can comprise a first array and a second array connected by a mechanical assembly, and the mechanical assembly can be configured to transition between a first state in which the first array and the second array can be flexibly connected and a second state in which the first array and the second array can be rigidly connected. The mechanical assembly can comprise a shape memory component and/or a mechanical linkage.

[037] In some embodiments, the system is configured to: automatically identify one or more tissue landmarks; and/or allow an operator to manually identify one or more tissue landmarks, and the landmark identification is used to: automatically position and/or reposition the ultrasound array; and/or allow an operator to manually position and/or reposition the ultrasound array. A tissue landmark can comprise the verumontanum. The system can be configured to continuously and/or intermittently image tissue during a treatment performed using the ultrasound device, such as to track the progress of the treatment and/or to ensure proper location of the ultrasound array during the treatment. The system can be configured to track the progress of the treatment and/or ensure proper location of the ultrasound array during the treatment by monitoring changes in the tissue being treated.

[038] In some embodiments, the ultrasound device comprises a distal portion configured for insertion through the urethra, and the system is configured to image tissue of the bladder and/or locations within the bladder.

[039] In some embodiments, the ultrasound device and/or another component of the system is configured to perform a biopsy procedure on the patient.

[040] In some embodiments, the ultrasound device comprises a distal portion configured for insertion through a body lumen, and the system is configured to create a set of one or more images during and/or after insertion through the body lumen, and the system is configured to optimize the set of one or more images. The system can be configured to perform the optimization using harmonic imaging. The body lumen can comprise the prostatic urethra.

[041] In some embodiments, the system is configured to determine one or more tissue characteristics. The system can be configured to determine the tissue characteristics based on attenuation of ultrasound delivered by the ultrasound array. The system can be configured to use the determined tissue characteristics to: predict the efficacy of an ablation, stimulation, and/or other tissue treatment; determine ultrasound delivery parameters that are used to perform an ablation, stimulation, and/or other tissue treatment; and/or calibrate an imaging-related portion, an energy delivery-related portion, and/or other portion of the system. [042] In some embodiments, the ultrasound device is configured to deliver ultrasound to treat the patient, and the system is configured to monitor the progress of the treatment. The treatment can comprise ablation of tissue, stimulation of tissue, and/or other tissue treatment. The system can be configured to perform the monitoring of the progress of the treatment by simulating heat propagation that results from the delivery of the ultrasound. The system can be configured to simulate the heat propagation based on: ultrasound delivery parameters; parameters of the ultrasound device; and/or parameters of the tissue and other material proximate the ultrasound array during the delivery of the ultrasound. The system can be configured to simulate the heat propagation based on measurement of tissue attenuation using ultrasound images produced by the system. The system can be configured to measure the tissue attenuation via an analysis of signal-to-noise ratio versus depth. The analysis can comprise an analysis of data taken before and during the delivery of the ultrasound energy of the treatment. The system can be further configured to provide a confidence range associated with the monitoring of the progress of the treatment. In the monitoring of the treatment, the system can be configured to account for changes in one or more properties of tissue or otherwise related to tissue, such as one or more tissue-related properties selected from the group consisting of: absorption; perfusion; backscatter; temperature; elasticity; displacement (e.g., as caused by energy delivery); intensity distribution; other tissue properties that can change during the treatment; and combinations of these. The system can be configured to monitor one or more parameters of the ultrasound transducers, and the system can be configured to perform the monitoring of the progress of the treatment based on the ultrasound transducer parameters. The system can be configured to collect image data, and the system can be configured to perform the monitoring of the progress of the treatment based on the collected image data. The system can use a local image intensity statistics technique to evaluate changes in tissue over time. The collected image data can comprise images taken prior to the treatment, during the treatment, and after the treatment. The local image intensity statistics technique can include extracting local image statistics. The local image statistics can comprise: local means; local standard deviations; local extrema; local kurtosis; local skewness; and/or local higher-order standardization moments. The image intensity statistics technique can include: principal component analysis; singular value decomposition; and/or other feature extraction and/or selection techniques. The monitoring of the treatment can comprise: capturing a first set of one or more images prior to the treatment; capturing a second set of one or more images 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. The system can be configured to produce a visual output in which tissue properties representing the effects of the treatment can be highlighted, color-coded, segmented, and/or otherwise graphically differentiated.

[043] In some embodiments, the system is configured to perform a treatment procedure comprising delivery of ultrasound, and the system is further configured to produce a treatment log representing treatment parameters and/or treatment results. The treatment log can comprise a comparison of tissue intended to be treated and actual tissue treated. The system can be configured to produce the treatment log prior to the completion of the treatment procedure. The treatment log can comprise an analysis of pressure zones; ablation tissue volumes; ablation tissue volumes relative to total tissue volumes; stimulation tissue volumes; and/or stimulation tissue volumes relative to total tissue volumes.

[044] In some embodiments, the ultrasound device comprises a catheter device.

[045] In some embodiments, the ultrasound device comprises 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 thereof.

[046] In some embodiments, the ultrasound device comprises a distal portion that is constructed and arranged to be inserted into and/or through the urethra of the patient.

[047] In some embodiments, the ultrasound device comprises a distal portion that is configured to be inserted into and/or through one or more lumens, openings, and/or other body conduits of a patient 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 thereof.

[048] In some embodiments, the ultrasound device further comprises a thermally-insulative layer surrounding at least a portion of the ultrasound array.

[049] In some embodiments, the ultrasound device comprises an expandable anchoring element configured to anchor the ultrasound array relative to the target tissue. The expandable anchor can comprise an inflatable balloon. The expandable anchor can be configured to be expanded in the bladder of the patient. The ultrasound device can comprise a removable sleeve, and the removable sleeve can comprise the expandable anchor. The removable sleeve can comprise a thermally-insulative layer.

[050] In some embodiments, the ultrasound device comprises one rigid segment and one or more flexible segments.

[051] In some embodiments, the ultrasound device comprises a proximal portion, a distal portion, and a lumen extending from the proximal portion to the distal portion. The lumen can be constructed and arranged to slidingly receive an elongate device comprising a diagnostic device, a treatment device, or both. The elongate device can comprise a cystoscope and/or a photoacoustic device. The system can be configured to deliver a fluid through the lumen to achieve and/or enhance acoustic coupling between the ultrasound array and the target tissue. The system can be configured to deliver a fluid through the lumen to cool at least the ultrasound array.

[052] In some embodiments, the ultrasound device comprises a proximal portion and a lumen extending from the proximal portion, and delivery of fluid into the lumen is configured to perform a function selected from the group consisting of: achieve and/or enhance acoustic coupling between the ultrasound array and the target tissue; change the flexibility of the ultrasound device; change the straightness of the ultrasound device; and combinations thereof. [053] In some embodiments, the system is configured to reduce a gripping force applied to the ultrasound device. The system can be configured to reduce the gripping force by: delivering one or more ultrasound pulses; causing one or more portions of the ultrasound device to vibrate; or both.

[054] In some embodiments, the ultrasound device is configured to deliver at least 100W/cm² of energy to treat prostate tissue, tumor tissue, and/or other tissue.

[055] In some embodiments, the system can further comprise an introducer device configured to be inserted into the patient and to slidingly receive the ultrasound device.

[056] In some embodiments, the ultrasound device is configured to be introduced through a lumen of 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. [057] In some embodiments, the ultrasound device is configured to be inserted through a device configured to be inserted through the bulbar urethra. [058] In some embodiments, the ultrasound device comprises a vibration element configured to reduce insertion force encountered as the ultrasound device is translated through a body conduit of the patient.

[059] In some embodiments, the ultrasound device comprises a distal portion comprising a coating. The coating can comprise a PTFE and/or other friction-reducing coating.

[060] In some embodiments, the one or more ultrasound transducers comprise one or more CMUT transducers.

[061] In some embodiments, the one or more ultrasound transducers comprise one or more piezo transducers.

[062] In some embodiments, the one or more ultrasound transducers comprise one or more CMUT transducers and one or more piezo transducers.

[063] In some embodiments, the system includes one or more protection diodes configured to prevent damage to the one or more ultrasound transducers. The one or more protection diodes can each have adjustable voltage limits. The one or more protection diodes can be configured to provide high voltage spike protection of the one or more ultrasound transducers. The one or more protection diodes can be configured to provide high voltage spike protection to prevent a cascading breakdown of the one or more ultrasound transducers. The system can comprise a feedback control system that varies the amplitude output and/or phase output of the one or more ultrasound transducers.

[064] In some embodiments, the ultrasound array comprises multiple ultrasound arrays, each including one or more ultrasound transducers. The multiple ultrasound arrays can be constructed and arranged to ablate, stimulate, and/or otherwise treat tissue with a volume of at least lOcc, such as at least 20cc, 40cc, 80cc, 120cc, and/or 150cc. The ultrasound device can be configured to be guided via images provided by the ultrasound device and to deliver treatment energy to tissue. The system can be configured to deliver the energy (e.g., ablation energy) from the prostatic urethra. The multiple arrays can be configured to independently create images of the patient, and the images created can be used to provide: guidance information; diagnostic information; and/or treatment planning information. The system further comprises a set of electrical connections and a multiplexer, and the multiplexer can be configured to selectively connect the electrical connections to each of the multiple ultrasound arrays. A first ultrasound array can be configured to transmit ultrasound and a second ultrasound array can be configured to receive the transmitted ultrasound, and the received ultrasound can be used to detect and/or measure the relative position between the first ultrasound array and the second ultrasound array. The first ultrasound array and the second ultrasound array can each comprise an array of at least 128 CMUT ultrasound transducers. The relative position between the first ultrasound array and the second ultrasound array can be used to determine delays, and the delays can be used in creating images using both the first ultrasound array and the second ultrasound array. The relative position between the first ultrasound array and the second ultrasound array can be used to determine delays, and the delays can be used in delivering ultrasound energy (e.g., ablation energy, stimulation energy, or both) to tissue using both the first ultrasound array and the second ultrasound array.

[065] In some embodiments, each of the one or more ultrasound transducers of the ultrasound array is configured to switch between an imaging mode and a treatment mode (e.g., an ablating mode, a stimulating mode, and/or other treatment mode) in less than 6 seconds, 100msec, 10msec, and/or 1 millisecond. The system can comprise a switching assembly configured to perform the switching of the ultrasound transducers between the imaging mode and the treatment 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, treatment energy drive circuitry (e.g., ablation drive circuitry stimulation drive circuitry, and/or other treatment energy drive circuitry), and a set of switches configured to switch between connecting the one or more ultrasound transducers to the imaging drive circuitry and the treatment energy drive circuitry. The set of switches can comprise MEMS switches and/or low-resistance, low-capacitance switches. The imaging drive circuitry can comprise a set of receive amplifiers, and a receive amplifier can be positioned proximal and proximate to each switch of the set of switches. The switching assembly can further comprise a set of bias tees, each bias tee positioned distal to each switch of the set of switches and configured to provide a DC bias to the associated ultrasound transducer. The switching assembly can comprise an adjustable overvoltage protection circuit. The treatment energy drive circuitry can comprise an overshoot protection circuit. The set of switches can comprise a corresponding set of pull-down resistors, each resistor having a resistance of at least 5kOhm and/or at least IMOhm, and configured to dissipate undesired voltage present at each switch. The switching assembly can be configured to operably connect and disconnect each of the ultrasound elements to a bias voltage source. The switching assembly can be configured to test for short-circuits by connecting an ultrasound element to the bias voltage source and measuring the current delivered by the bias voltage source.

[066] In some embodiments, the ultrasound transducers of the ultrasound array are arranged in both a forward-looking and side-looking arrangement.

[067] In some embodiments, the ultrasound device further comprises an acoustic lens.

[068] In some embodiments, the ultrasound device further comprises a handle. The system further comprises a user interface, and the handle can comprise at least a portion of the user interface. The handle can comprise an alert element comprising a tactile transducer.

[069] In some embodiments, the ultrasound device further comprises a cooling module. The cooling module can be mechanically coupled to and/or otherwise positioned proximate to the ultrasound array. The cooling module can be configured to cool the ultrasound array, tissue proximate and/or treated by the ultrasound array, or both. The cooling module can comprise a thermoelectric cooling module. The cooling module can comprise a solid state cooling module. The cooling module can comprise a cooling element and a solid thermal conductor configured to conduct heat away from the cooling element. The cooling module can comprise a fluid pathway that can be positioned within the ultrasound device.

[070] In some embodiments, the ultrasound device comprises a sensor module including one or more sensors. The one or more sensors can comprise one or more temperature sensors. The one or more sensors can comprise one or more sensors selected from the group consisting of: temperature sensor; pressure sensor; strain gauge; accelerometer; gyroscope, inertial measurement unit (IMU), physiologic sensor; GPS sensor; and combinations thereof. The sensor module can be configured to record a parameter of target tissue and/or non-target tissue. The non-target tissue parameter can comprise a parameter selected from the group consisting of temperature; pressure; and combinations thereof. The sensor module can comprise at least one sensor configured to articulate. The at least one articulating sensor can be configured to rotate and record data while avoiding applying forces to tissue proximate the at least one articulating sensor.

[071] In some embodiments, the system comprises a console comprising an ultrasound module for providing drive signals to the ultrasound array. The ultrasound module can comprise a dual -frequency signal generator. The ultrasound module can be configured to produce a drive signal at a first frequency for delivering ultrasound to tissue that can be located at a distance of no more than DI from the ultrasound array, and to produce a drive signal at a second frequency for delivering ultrasound to target tissue that can be located at a distance of at least D2 from the ultrasound array, and D2 can be the same or larger than DI, and the first frequency can be higher than the second frequency. The first frequency can comprise a frequency of at least 4.5 MHz, and the second frequency can comprise a frequency of no more than 3.5 MHz, and DI can comprise a distance of no more than 25mm, and D2 can comprise a distance of at least 25mm. The first frequency can comprise a frequency of no more than 5.5 MHz and/or the second frequency can comprise a frequency of at least 2.5 MHz. DI can comprise a distance of at least 0.001mm and D2 can comprise a distance of no more than 50mm. The ultrasound module can comprise a tuned circuit that operates at one or more frequencies of at least 1 MHz, and/or at one or more frequencies of no more than 10 MHz. The ultrasound module can comprise two electronically switchable tuned circuits configured to provide operation at multiple different frequencies. The ultrasound module 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. The ultrasound module can be configured to operate a first set of one or more transducers of the ultrasound array at a first frequency and to simultaneously operate a second set of one or more transducers of the ultrasound array at a second frequency that can be different than the first frequency.

[072] In some embodiments, the ultrasound device comprises an identifying component, and the console is configured to receive information from the identifying component. The identifying component can comprise an RFID. The information received from the identifying component can comprise diagnostic information, calibration information, and/or manufacturing information of the ultrasound device. The information received from the identifying component can be used by the console to confirm the ultrasound device can be properly indicated, properly configured, and/or otherwise ready for use.

[073] In some embodiments, the system comprises a cooling device. The ultrasound device can comprise a cooling module that can be constructed and arranged to receive cooling fluid provided by the cooling device. The cooling module can comprise one or more fluid pathways that can be positioned within the ultrasound device, and the one or more fluid pathways receive the cooling fluid provided by the cooling device.

[074] In some embodiments, the system can further comprise a processing unit comprising a processor and a memory storage element coupled to the processor, and the memory storage component stores instructions for the processor to perform an algorithm. The system further comprises a console, and the console can comprise at least a portion of the processing unit. The ultrasound device can comprise at least a portion of the processing unit. The algorithm can comprise an artificial intelligence algorithm. The system can be configured to produce a multidimensional image of tissue, and the algorithm can comprise an artificial intelligence algorithm or other algorithm that can be configured to: identify tissue areas to avoid treating; and/or suggest tissue areas to be treated. The algorithm can comprise an artificial intelligence algorithm or other algorithm that can be configured to assess image data to maintain a focal spot for delivery of treatment energy (e.g., ablation energy, stimulation energy, and/or other treatment energy). The algorithm can be configured to modify delays of signals delivered to the ultrasound transducers to maintain the focal spot. The algorithm can comprise an artificial intelligence algorithm or other algorithm that can be configured to identify one or more treatment energy delivery patterns (e.g., ablation patterns) that reduce edema or other undesired effects of the delivery of ablation or other treatment energy to the target tissue. The processing unit can further comprise at least one application configured to be provided and/or performed by the system.

[075] In some embodiments, the system comprises a user interface. The system further comprises a console, and the console can comprise at least a portion of the user interface. The ultrasound device can comprise at least a portion of the user interface. The user interface can comprise an alert element. The alert element can comprise a tactile transducer positioned in the ultrasound device. The user interface can comprise a touchscreen display and/or other display. The user interface can be configured as a graphical user interface.

[076] In some embodiments, the system can further comprise one or more functional elements. The one or more functional elements can comprise one or more sensors and/or one or more transducers. The functional element can comprise one or more vacuum ports positioned proximate the ultrasound array. The one or more vacuum ports can be configured to: prevent motion of the ultrasound array; maintain a portion of the ultrasound device in contact with tissue; or both.

[077] In some embodiments, the system can further comprise a robotic manipulator configured to robotically manipulate the ultrasound device and/or one or more other components of the system. The robotic manipulator can be configured to rotate the ultrasound device to create a 360° image of tissue and/or at least an image of tissue of more than 180°.

[078] In some embodiments, the system can further comprise an agent comprising one or more agents.

[079] In some embodiments, the system can further comprise a network and at least one server.

[080] In some embodiments, the system can further comprise a second medical device. [081] In some embodiments, the system can further comprise a second imaging device comprising at least one imaging device. The second imaging device 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 thereof. The system can be configured to produce a first set of one or more images using the ultrasound device and to produce a second set of one or more images using the second imaging device, and the system can be further configured to compare and/or combine the first set of images with the second set of images.

[082] In some embodiments, the system can further comprise an accessory device comprising at least one accessory device. The accessory device can comprise a positioning device configured to establish one or more reference points used by the ultrasound device for creating images, delivering treatment energy (e.g., ablation energy, stimulation energy, and/or other treatment energy), or both. The accessory device can comprise a balloon catheter, and the balloon catheter can be configured to dilate the urethral passage.

[083] 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

[084] 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. It will be clearly understood that, if a prior art publication is referred to herein, this reference does not constitute an admission that the publication forms part of the common general knowledge in the art in any country.

BRIEF DESCRIPTION OF THE DRAWINGS

[085] Fig. 1 illustrates a block diagram of an embodiment of a system for performing a medical procedure on a patient using ultrasound energy, consistent with the present inventive concepts.

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

[087] Fig. 2 illustrates a schematic view of a system comprising an ultrasound device and a robotic manipulation assembly, consistent with the present inventive concepts.

[088] Figs. 3 illustrates a schematic view of an ultrasound array, consistent with the present inventive concepts.

[089] Fig. 4 illustrates a sectional schematic view of a CMUT cell, consistent with the present inventive concepts.

[090] Figs. 5A through 5C illustrate sectional views of CMUT elements comprising multiple CMUT cells, and a graph of output pressure versus frequency, respectively, consistent with the present inventive concepts.

DETAILED DESCRIPTION OF THE DRAWINGS [091 ] 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.

[092] 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.

[093] 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.

[094] 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.).

[095] 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.

[096] 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.

[097] 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. [098] 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.

[099] 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. [100] 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.

[101] 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.

[102] 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.

[103] 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.

[104] 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.

[105] 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.

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

[107] 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 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.

[108] 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 hereinabove.

[109] 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.

[110] 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.

[111] 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 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. [112] 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.

[113] 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.

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

[115] 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.

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

[117] 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.

[118] 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.

[119] 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.

[120] 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.

[121] 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.

[122] 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.

[123] 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 system comprises an ultrasound device comprising an ultrasound array including one or more ultrasound transducers. The ultrasound array is configured to emit ultrasound to target tissue of the patient.

[124] 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 comprising a diagnostic procedure, a treatment procedure, or both. The patient can comprise a human and/or other mammalian patient, “patient” herein. System 10 comprises one, two, or more ultrasound devices, ultrasound 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 ultrasound device 100 and/or other component of system 10. System 10, ultrasound 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 Fig. 1A and/or otherwise herein.

[125] Ultrasound device 100 can comprise one, two, or more devices configured to deliver and/or receive ultrasound energy (also referred to as simply “ultrasound”). Each ultrasound device 100 comprises one, two, or more ultrasound arrays, ultrasound array 150, and each array 150 can comprise one or more ultrasound transducers, ultrasound transducer 155, also referred to as UST 155, shown. Each UST 155 can be configured to deliver ultrasound, receive ultrasound, or both. Each UST 155 can comprise a piezo-based ultrasound transducer, or a capacitive micromachined ultrasonic transducer (CMUT). In some embodiments, UST 155 can comprise CMUT element 1551 described herein.

[126] 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 ultrasound device 100 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); 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 ultrasound device 100, for example to transmit power and/or signals to, and/or receive signals from device 100. 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.

[127] System 10 can comprise one, two, or more cooling devices, cooling device 300 shown, that are configured to lower the temperature (“cool”) a portion of device 100 and/or another component of system 10. Cooling device 300 can be operably attached (e.g., fluidly attached) to at least ultrasound device 100, such as when supplying a cooling fluid to cooling module 160 of 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 300. The cooling fluid used by cooling device 300 can comprise a fluid selected from the group consisting of: water; silicone oil; fluorinated liquid; propylene glycol; ethylene glycol; mineral oil; liquid metal alloys; and combinations of these. These fluid pathways can be positioned and arranged in close proximity to ultrasound array 150 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. Cooling device 300 can be of similar construction and arrangement as cooling device 300 described in reference to Fig. 1A and/or otherwise herein.

[128] System 10 can comprise one, two, or more additional medical devices, second medical device 400 shown, that can be used to perform a diagnostic procedure, a treatment procedure, and/or other medical procedure. Second medical device 400 can be of similar construction and arrangement as second medical device 400 described in reference to Fig. 1 A and/or otherwise herein.

[129] System 10 can comprise one, two, or more modules configured to perform a function, processing unit 50 shown. Ultrasound device 100, console 200, cooling device 300, second medical device 400, 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.

System 10 can comprise one, two, or more modules configured to provide a user interface, user interface 60 shown. Ultrasound device 100, console 200, cooling device 300, second medical device 400, 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. 1A and/or otherwise herein.

[130] System 10 can comprise one, two, or more elements, assemblies, and/or other components configured to perform a function, functional element 99 shown. Ultrasound device 100, console 200, cooling device 300, second medical device 400, 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.

[131] In some embodiments, system 10 is configured to perform an imaging procedure, such as when one or more UST 155 deliver ultrasound to tissue, and one or more UST 155 (e.g., similar and/or dissimilar UST 155) receive reflections of the delivered ultrasound, such that system 10 can produce one or more images of tissue (e g., target tissue) based on the timing and/or other parameters of the delivered and received ultrasound.

[132] 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 ultrasound energy (e.g., to tissue). In these embodiments, ultrasound can be delivered to tissue by each UST 155, such as ultrasound delivered to “target tissue” to be ablated, stimulated, and/or otherwise treated. Alternatively or additionally, a treatment procedure can comprise a procedure in which an implant and/or an agent that has been placed inside the patient receives ultrasound energy from ultrasound device 100, such as ultrasound energy delivered to activate, supply power to, and/or otherwise modify the implant and/or agent. 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.

[133] 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 (e.g., create images of tissue, an agent, and/or an implant within the patient), and deliver a treatment (e.g., a treatment comprising ablating, stimulating, 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 (e.g., create images of tissue, an agent, and/or an implant within the patient), and deliver a treatment (e.g., a treatment comprising ablating, stimulating, 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 collected simultaneously with, and/or prior to the performance of the treatment.

[134] 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. In some embodiments, system 10 is configured to perform a biopsy (e.g., a tissue biopsy), such as when system 10 is configured to image tissue to be biopsied prior to the biopsy. [135] 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, kidney, liver, lung, skin, and/or stomach; and combinations of these.

[136] In some embodiments, system 10 is configured to perform: imaging (e.g., used to perform a diagnostic analysis); treatment (e.g., ablation, stimulation, 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; 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.

[137] In some embodiments, system 10 is configured to perform a diagnostic procedure 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, and/or tissue of the ejaculatory duct. In the treatment 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.

[138] In some embodiments, system 10 is 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). 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, stimulation, or both) 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” 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).

[139] In some embodiments, system 10 is configured to perform a diagnostic and/or treatment procedure comprising the delivery of ultrasound energy to activate a pharmaceutical and/or other agent; and/or to enhance the efficacy of a pharmaceutical and/or other agent.

[140] 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, such as to supply power to and/or otherwise modify the implant and/or agent.

[141] 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 copending applications: 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 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, 2023; 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.

[142] 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. 1A 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 ultrasound device 100 including ultrasound array 150 and ultrasound transducer 155, each as shown, as well as processing unit 50, user interface 60, functional element 99, console 200, cooling device 300, and/or second medical device 400, also as shown. In some embodiments, system 10 further comprises robotic manipulator assembly 500, second imaging device 600, and/or accessory device 700, each as shown and described herein. [143] 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: ultrasound device 100, console 200, cooling device 300, second medical device 400, robotic manipulator assembly 500, second imaging device 600, accessory device 700, 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, 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 ultrasound 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 ultrasound device 100, console 200, a server (e.g., server 80 described herein), and/or other component of system 10. Performance of a function of system 10 is described hereinabove 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.

[144] As described herein, processing unit 50 (e.g., processing unit 105 of ultrasound device 100, processing unit 205 of console 205, and/or a processing unit of another system 10 component), can be configured to perform one or more algorithms, algorithm 55. Each algorithm 55 can comprise an artificial intelligence algorithm or other algorithm. In some embodiments, system 10 is configured to produce a volumetric multi-dimensional image of tissue (e.g., as described herein), and algorithm 55 comprises an artificial intelligence algorithm or other algorithm that is configured to: identify tissue areas to avoid treating; and/or suggest tissue areas to be treated.

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

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

[147] Algorithm 55 can comprise an artificial intelligence algorithm or other algorithm that is configured to perform a self-diagnostic of system 10. For example, algorithm 55 can be configured to analyze image data (e.g., live or other image data collected by ultrasound device 100) during an intended movement of device 100, robotic manipulator assembly 500, and/or other system 10 component, in order to detect sticking and/or other undesired motion (e.g., lack of motion) of the system 10 component (e.g., where system 10 enters an alert state when the undesired motion is detected). Alternatively, or additionally, algorithm 55 can be configured to analyze data provided by a system 10 sensor (e.g., a functional element comprising a force sensor, accelerometer, position-encoder, a current sensor configured to monitor current of a motor or other motive element, and/or other sensor), and to detect undesired motion (e.g., lack of motion) based on the analysis of the sensor data.

[148] Algorithm 55 can comprise an artificial intelligence algorithm or other algorithm that is configured to promote image intensity uniformity, such as when algorithm 55 is configured to analyze and attenuate thermal noise.

[149] Algorithm 55 can comprise an artificial intelligence algorithm or other algorithm that is configured to remove static ultrasound artifacts due to reflections of the incident ultrasound beam from the surface of shaft assembly 130.

[150] Algorithm 55 can comprise an artificial intelligence algorithm or other algorithm that is configured to perform image processing and/or enhancing, such as to identify and/or enable the identification of important structures (e.g. implants or tissue structures) in an image, for and/or by the clinician using system 10.

[151] Algorithm 55 can comprise an artificial intelligence algorithm or other algorithm that is configured to analyze acquired data (e.g., image data and/or other data) stored in memory (e.g., stored in memory 52), such as to provide a treatment plan (e.g., a proposed treatment plan to be used “as is”, and/or modified by a clinician using system 10).

[152] 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: ultrasound device 100, console 200, cooling device 300, second medical device 400, robotic manipulator assembly 500, second imaging device 600, accessory device 700, 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 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 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 ultrasound device 100, console 200, accessory device 700, and/or other components of system 10 described herein.

[153] 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: ultrasound device 100, console 200, cooling device 300, second medical device 400, robotic manipulator assembly 500, second imaging device 600, accessory device 700, 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. [154] 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 ultrasound device 100. The second component can comprise another component of system 10, for example console 200, cooling device 300, second medical device 400, robotic manipulator assembly 500, second imaging device 600, and/or accessory device 700.

[155] Ultrasound 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.

[156] In some embodiments, ultrasound device 100 comprises a user interface 106 comprising at least a portion of user interface 60 of system 10. User interface 106 of ultrasound 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.

[157] 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. Ultrasound device 100 can comprise a catheter device. In some embodiments, ultrasound device 100 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.

[158] In some embodiments, ultrasound device 100 is constructed and arranged to be inserted through a lumen of a second medical device 400 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. Ultrasound device 100 can be configured to be inserted through a second medical device 400 that is configured to be inserted through the bulbar urethra.

[159] Ultrasound device 100 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.

[160] In some embodiments, ultrasound 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 ultrasound device 100 comprises processing unit 105, user interface 106, and/or communication module 107, respectively, each shown.

[161] In some embodiments, ultrasound 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 ultrasound array 150 and/or another portion of ultrasound device 100. In some embodiments, cooling module 160 is operably connected (e.g., fluidly connected) to cooling device 300 (e.g., when cooling device 300 provides cooling fluid to one or more lumens or other flow conduits of ultrasound device 100 such that ultrasound array 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 ultrasound array 150. Cooling module 160 can be configured to cool ultrasound array 150, tissue proximate or treated by ultrasound array 150, or both. Cooling module 160 can comprise: a thermoelectric cooling module; a solid state cooling module; a cooling element and a thermal conductor (e.g., a solid or stranded thermal conductor configured to draw heat energy away from the cooling element and/or array 150); a fluid pathway (e.g., a fluid pathway configured to receive cooling fluid from cooling device 300).

[162] In some embodiments, ultrasound 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 ultrasound array 150 and/or another portion of ultrasound device 100, such as to allow closed-loop cooling of device 100 via cooling device 300 (e.g. when sensor module 120 provides temperature information to cooling device 300). Sensor 125 can comprise one, two, three or more sensors selected from the group consisting of: temperature sensor; pressure sensor; strain gauge; accelerometer; gyroscope, inertial measurement unit (IMU), physiologic sensor; GPS 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, or other parameters. 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.

[163] Ultrasound device 100 includes ultrasound array 150 which includes one or more ultrasound transducers, transducers 155, as described herein. For example, transducers 155 can comprise one or more capacitive micromachined ultrasound transducers (CMUTs), one or more piezo transducers, or one or more of each.

[164] Ultrasound array 150 can comprise multiple arrays 150, each array comprising one or more ultrasound transducers 155. The multiple ultrasound arrays 150 can comprise multiple independently activatable arrays, and the arrays 150 can be constructed and arranged to ablate, stimulate, and/or otherwise treat tissue with a volume of at least lOcc, such as at least 20cc, 40cc, 80cc, 120cc, and/or 150cc. Ultrasound device 100 can be configured to be guided via images provided by the ultrasound device 100, and to deliver treatment energy (e.g., ablation energy) to tissue, such as when delivering energy while array 150 is positioned within the prostatic urethra. Multiple arrays 150 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 be used to provide: guidance information; diagnostic information; treatment assurance information; treatment monitoring information; and/or treatment planning information. Ultrasound device 100, console 200, and/or another component of system 10 can comprise a set of electrical connections and a multiplexer, where the multiplexer is configured to selectively connect the electrical connections to each of the multiple ultrasound arrays. A first ultrasound array 150a can be configured to transmit ultrasound, and a second ultrasound array 150b 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 150a and the second ultrasound array 150b. In some embodiments, first array 150a, second array 150b, 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 150a, a second ultrasound array 150b, or both, can each comprise an array of at least 128 CMUT ultrasound transducers. The relative position between a first ultrasound array 150a and a second ultrasound array 150b can be used by system 10 to determine delays, wherein the delays are used in creating images using both the first ultrasound array 150a and the second ultrasound array 150b. Alternatively, or additionally, the relative position between the first ultrasound array and the second ultrasound array can be used to determine delays, and the delays can be used in delivering treatment energy (e.g., ablation energy, stimulation energy, and/or other treatment energy) to tissue using both the first ultrasound array 150a and the second ultrasound array 150b.

[165] In some embodiments, a set of one or more transducers 155 of one or more ultrasound arrays 150 can be configured to switch between an “imaging mode” and a “treatment mode”, such as when switching between an imaging mode in which imaging-level ultrasound energy is transmitted to tissue and reflections are received from tissue, and a treatment mode in which ablation, stimulation, and/or other treatment -level ultrasound energy is delivered to ablate, stimulate, 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 10msec. 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 or other treatment monitoring during ablation, stimulation, and/or other tissue treatment). Ultrasound device 100, console 200, and/or another component of system 10 can comprise a switching assembly that is configured to perform the switching of the ultrasound transducers between the imaging mode and the treatment 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, treatment energy drive circuitry (e.g., ablation drive circuitry, stimulation drive circuitry, and/or other treatment energy drive circuitry), and a set of switches configured to switch between connecting the one or more ultrasound transducers 155 to the imaging drive circuitry and the treatment energy 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 and proximate to each switch of the set of switches. The switching assembly can further comprise a set of bias tees, and 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 155. The switching assembly can comprise an adjustable overvoltage protection circuit. The treatment energy drive circuitry can comprise an overshoot protection circuit. The set of switches can comprise a corresponding set of pull-down resistors, and each resistor can comprise a resistance of at least 5kOhm, such as 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 155 to a bias voltage source. The switching assembly can be configured to test for short-circuits by connecting an ultrasound transducer 155 to the bias voltage source and measuring the current delivered by the bias voltage source.

[166] Ultrasound array 150 can comprise a set of two or more ultrasound transducers 155 that are arranged in a forward-looking arrangement, a side-looking arrangement, or both. In some embodiments, an acoustic lens, acoustic lens 151 shown, covers all or a portion of the transducers 155. Acoustic lens 151 can be configured to provide focusing in the elevation direction of ultrasound array 150, such as to reduce the focal spot size in collaboration with the electronic focusing in the azimuth direction. In these embodiments, the power density at the focal point is increased, such as to enable faster treatment (e.g., faster ablation). The material of acoustic lens 151 can be chosen to have slower speed of sound than human tissue (or water) and/or can be convex toward the tissue. The mechanical impedance of acoustic lens 151 material can be chosen to match the impedance of the tissue and/or other material proximate array 150 to provide optimized transmission of the ultrasound energy into the tissue. In some embodiments, the material of acoustic lens 151 can be chosen to help in damping lateral modes that propagate along the surface of array 150, for example lateral modes that could compromise the imaging and/or treatment performance (e.g., ablation performance and/or stimulation performance) of ultrasound device 100.

[167] In some embodiments, at least a portion of ultrasound array 150 is surrounded by a thermally-insulative layer (e.g., a portion of shaft assembly 130 comprising a thermally- insulative layer). The thermally-insulative layer can comprise a layer constructed and arranged to prevent undesired damage to tissue via an ultrasound array 150 that is at a temperature above body temperature.

[168] In some embodiments, ultrasound device 100 includes a functional element 199 that comprises an inflatable or otherwise expandable anchoring element (e.g., an inflatable balloon), such as an anchoring element configured to anchor ultrasound array 150 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 150 during imaging, tissue treatment, and/or other procedure performed using device 100). In some embodiments, functional element 99 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 150 that is at a temperature above body temperature.

[169] In some embodiments, ultrasound 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 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 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 400. For example, lumen 135 can be configured to slidingly receive a second medical device 400 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 ultrasound array 150 and the target tissue; cool at least ultrasound array 150; change the flexibility of one or more portions of shaft assembly 130; and any combination of one or more of these.

[170] In some embodiments, ultrasound 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 150 and configured to prevent ultrasound array 150 from moving (e.g., during imaging and/or treatment); keep one or more portions of ultrasound device 100 in contact with tissue; or both.

[171] In some embodiments, ultrasound 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 ultrasound 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 ultrasound device 100. The information received from the identifying component can be used by console 200 and/or another component of system 10 to confirm ultrasound device 100 is properly indicated, properly configured, and/or otherwise ready for use.

[172] In some embodiments, ultrasound device 100, robotic manipulator assembly 500, and/or another component of system 10, is configured to reduce a “gripping” force applied to ultrasound device 100 by tissue when a distal portion of ultrasound 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, ultrasound device 100 is configured to deliver one or more ultrasonic pulses to reduce a gripping force. Alternatively or additionally, ultrasound device 100, robotic manipulator assembly 500, and/or another component of system 10 is configured to cause one or more portions of device 100 to vibrate, such as to reduce a gripping force. In some embodiments, ultrasound device 100 includes a functional element 199 comprising a vibrating element such as a vibrating transducer configured to reduce a gripping force and/or to reduce forces encountered while translating (e g., advancing) the distal portion of ultrasound device 100 through the urethra or other body conduit.

Alternatively or additionally, ultrasound device 100 can include a functional element 199 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 ultrasound device 100 through the urethra or other body conduit. For example, the coating can comprise a polytetrafluoroethylene (PTFE) coating and/or other friction-reducing coating.

[173] In some embodiments, ultrasound device 100 is configured to deliver power at a high power density to treat (e.g., ablate) tissue, such as a power density of at least 100W/cm². For example, device 100 can be configured to deliver at least 100W/cm² delivered to treat prostate tissue in a patient with BPH while device 100 is positioned within a urethra of the patient. Device 100 can be configured to deliver at least lOOW/cm² delivered to treat tumor tissue and/or other tissue. [174] Console 200 can comprise one or more consoles configured to operably attach to ultrasound device 100 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.

[175] Console 200 can be configured to operably connect to one or more other components of system 10, such as to ultrasound device 100 (e.g., multiple similar and/or different ultrasound devices 100). Console 200 can operably connect to ultrasound device 100 via a wired and/or a wireless connection, such as via a connection provided between communication module 107 of ultrasound 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 ultrasound device 100, from user interface 206, from communication module 207, 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 ultrasound device 100, 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 ultrasound device 100 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. Ultrasound device 100, console 200, cooling device 300, second medical device 400, 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).

[176] Console 200 can comprise one or more consoles, such as one or more similar and/or different consoles 200. [177] 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 150 of device 100; receive ultrasound signals (e.g., from recorded ultrasound reflections) from ultrasound array 150 of device 100; or both.

[178] 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 150, 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 150, 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 4.5 MHz and/or no more than 5.5 MHz, such as a frequency of approximately 5.0 MHz. Additionally, or alternatively, D2 can comprise a distance of 25mm or more, and the second frequency comprises a frequency of less than 3.5 MHz and/or at least 2.5 MHz, such as a frequency of approximately 3.0 MHz. In these embodiments, DI can comprise a distance of at least 0.001mm and D2 can comprise a distance of no more than 50mm.

[179] Ultrasound module 250 can comprise a tuned circuit that operates at one or more frequencies of at least 1 MHz, and/or at one or more frequencies of no more than 10 MHz. 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 155 of ultrasound array 150 at a first frequency and to simultaneously operate a second set of one or more transducers 155 of ultrasound array 150 at a second frequency that is different than the first frequency.

[180] System 10 can be configured to deliver high intensity focused ultrasound (HIFU) energy to tissue, such as to target tissue to be ablated and/or otherwise treated by the delivery of the HIFU energy. In some embodiments, ultrasound device 100 is 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 “HTFU beam” comprises a set of ultrasonic signals that are transmitted from ultrasound array 150 to a focal point (e.g., forming the HIFU beam). Furthermore, one or more HIFU beams can be “formed” (e.g., ultrasound array 150 can form a HIFU beam) and/or “delivered” (e.g., a HIFU beam can be delivered to target tissue) by ultrasound array 150. “Forming” and “delivering” a HIFU beam are used interchangeably herein. The ultrasonic signals of the HIFU beam comprise a wavelength . HIFU beams can be formed by an ultrasound array 150 comprising a one-dimensional (ID) array of transducers 155 and/or a two-dimensional (2D) array of transducers 155. Transducer 155 can comprise ultrasound transducers (e.g., CMUT ultrasound transducers) with a length or width dimension smaller than X, and/or a length or width dimension larger than one half . For example, when ultrasound array 150 comprises a ID array of transducers 155, transducers 155 can comprise rectangular transducers including a first (length) dimension and a second (width) dimension. The second dimension of rectangular transducers 155 can be less than X and/or greater than one half X. Additionally, or alternatively, when ultrasound array 150 comprises a 2D array of transducers 155, transducers 155 can comprise square (or near square) ultrasound transducers including an equal or near-equal (“equal” or “same” herein) first and second dimension. Both dimensions of square transducers 155 can be less than X and/or greater than one half X. Examples of transducer 155 dimensions related to the wavelength of the HIFU energy to be delivered are as follows. For HIFU comprising 5 MHz ultrasound signals, the wavelength X in tissue is approximately 0.3mm. The short dimensions of transducers 155 would be smaller than 0.3mm and larger than 0.15mm, such as 0.2mm. As another example, for HIFU comprising 3 MHz ultrasound signals, the wavelength X in tissue is approximately 0.5mm. The short dimensions of transducers 155 would be smaller than 0.5mm and larger than 0.25mm, such as 0.3mm. Ultrasound array 150 can be configured to deliver HIFU beams to a “highly focused” focal point, such as a focal point with a width of no more than 1mm, such as no more than 0.75mm, 0.6mm, 0.5mm, 0.3mm, 0.25mm, 0.2mm, or 0.15mm. In some embodiments, the focal point is at a depth of no more than 60mm, such as no more than 40mm. Ultrasound array 150 can be configured to steer (e.g., to adjust the focal point of) the HIFU beams, such as to deliver a HIFU beam to a focal point that is positioned away from the main beam axis of array 150 (e.g., an axis extending normal to the array from the center of the array). For example, ultrasound array 150 can be configured to steer the HIFU beams up to 30° from the main beam axis, such as at least 5°, 10°, 15°, 20°, 25°, and/or 30°.

[181] 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 155 to transmit ultrasound energy). HIFU driver 255 can comprise M transmit channels, and ultrasound array 150 can comprise N transducers 155. 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 155 of ultrasound array 150). 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 155. 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 150) 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 150.

[182] In some embodiments, HIFU driver 255 comprises one or more protection diodes 2551, where each protection diode 2551 can be configured to prevent damage to one or more ultrasound transducers 155. The one or more protection diodes 2551 can each have an adjustable voltage limit. The one or more protection diodes 2551 can be configured to provide high voltage spike protection of the one or more ultrasound transducers 155, such as to provide high voltage spike protection to prevent a “cascading breakdown” of the one or more ultrasound transducers. System 10 can comprise a functional element 99 comprising a feedback control system that varies the amplitude output and/or phase output of the one or more ultrasound transducers 155, such as to keep the amplitude and phase of the output voltage of each channel at a target value (e.g., where exceeding that value would result in damage or other undesired impact on transducers 155 and/or other component of ultrasound array 150).

[183] In some embodiments, ultrasound array 150 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 155 (e.g., two or more sets of transducers 155 that include one or more common elements) and/or non-overlapping sets of transducers 155. Each of the two or more HIFU beams can be independently 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.

[184] In some embodiments, the number M of transmit channels of HIFU driver 255 is less than the number N of transducers 155 of ultrasound array 150 (e.g., M < N). For example, a 2D array can comprise 1000 or more transducers 155, when HIFU driver 255 comprises 256 or less transmit channels. HIFU driver 255 can comprise one or more switching circuits, such as low loss switching circuits, that are configured to multiplex M transmit channels to N transducers 155. For example, HIFU driver 255 can comprise one or more MEMS switching circuits, such as a MEMS switching circuit with less than 1 Ohm series resistance. In some embodiments, the switching circuitry is configured to operably connect two or more transducers 155 to a single transmit channel simultaneously, such that a single transmit channel can drive the two or more transducers 155 simultaneously. In some embodiments, the total acoustic power available to be delivered by ultrasound array 150 is defined by the power output capabilities of HIFU driver 255. HIFU driver 255 can be configured to form one or more HIFU beams that deliver (collectively) the maximum available acoustic power enabled by HIFU driver 255, such as to deliver the maximum power available per transmit channel to each available transducer 155 to form the HIFU beam. Alternatively, or additionally, the HIFU driver 255 can be configured to deliver one or more HIFU beams that deliver (collectively) less than the maximum available acoustic power enabled by HIFU driver 255, such as to deliver less than the maximum enabled power to one or more transducers 155, and/or to utilize less than M transmit channels, or less than N transducers 155 to deliver the HIFU beams. [185] In some embodiments, the number M of transmit channels of HIFU driver 255 is greater than the number N of transducers 155 of ultrasound array 150 (e.g., M>N). For example, a 2D array can comprise 1000 or more transducers 155, and HIFU driver 255 can comprise 1024, 2048, or more transmit channels. HIFU driver 255 can comprise one or more switching circuits, such as are described herein, configured to multiplex M transmit channels to N transducers 155. In some embodiments, a single transmit channel can be multiplexed to each transducer 155 for a first energy delivery configuration (e.g., during an imaging step, and/or a low power HIFU energy delivery), and two or more transmit channels can be multiplexed to each of one or more transducers 155 for a second energy delivery configuration (e.g., during a high power HIFU energy delivery). In some embodiments, various transducers 155 are multiplexed to the same or different numbers of transmit channels during an energy delivery, for example transducers further from the target location can be multiplexed to a greater number of transmit channels, such as to deliver more energy. In some embodiments, HIFU driver 255 comprises transmit channels of varying power capacity, such as a first set of transmit channels configured to provide power to one or more transducers 155 at a first power level, and a second set of transmit channels configured to provide power to one or more transducers 155 at a second power level, greater than the first. In some embodiments, each transducer 155 has a corresponding transmit channel in each set of transmit channels (e.g., M = 2N).

[186] Ultrasound module 250 can comprise one or more ultrasound imaging drive circuitry components and/or signal recording components, imaging driver 256. Imaging driver 256 can comprise T transmit channels (e.g., driver channels configured to drive a transducer 155 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 155). 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 155 of ultrasound array 150). 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 received channels to N transducers 155 (e.g., low loss MEMS switches, as described herein). 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.

[187] In some embodiments, ultrasound device 100 is configured to transmit and/or receive imaging ultrasound energy and to deliver one or more HIFU beams simultaneously. For example, one or more transmit channels of HIFU driver 255 can drive one or more transducers 155 to deliver HIFU energy while one or more transmit and/or receive channels of imaging driver 256 are simultaneously driving and/or recording signals to and/or from one or more transducers 155. In some embodiments, HIFU driver 255 is configured to drive a HIFU beam from a subset of the N transducers 155, such as from x transducers 155, and imaging driver 256 is configured to image (e.g., transmit and receive imaging ultrasound energy) from a subset of the N transducers 155, such as from a subset containing no more than N-x transducers 155. Each subset of the N transducers 155 can comprise unique subsets (e.g., without any transducers 155 belonging to more than one subset). In some embodiments, the subset of transducers 155 comprise dynamic subsets, for example such that HIFU driver 255 can drive a HIFU beam from a first subset of x transducers (while imaging driver 256 images from a second subset of no more than N-x transducers), and HIFU driver 255 can subsequently drive a HIFU beam from a third subset of x transducers (while imaging driver 256 images from a fourth subset of no more than N-x transducers), wherein the first and third sets of transducers (and/or the second and fourth sets of transducers) are different (but potentially overlapping) subsets of transducers 155. For example, HIFU driver 255 and imaging driver 256 can each be configured to simultaneously multiplex respective transmit and receive channels to each transducer 155, such as to interleave HIFU beam delivery and imaging from different portions of ultrasound array 150 (e.g., from different subsets of transducers 155) throughout a combined imaging and HIFU treatment process.

[188] 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 fdtering, 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 ultrasound devices 100, 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.

[189] In some embodiments, data 85 includes data recorded during a medical procedure, for example data related to one or more ultrasound energy delivery 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).

[190] In some embodiments, server 80 is configured to communicate with one or more ultrasound 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 ultrasound 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., ultrasound device 100 usage information).

[191] 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. [192] 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: ultrasound device 100, console 200, cooling device 300, second medical device 400, robotic manipulator assembly 500, second imaging device 600, accessory device 700, 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 ultrasound device 100 and/or other component of system 10. For example, ultrasound device 100 can comprise at least a portion of alert assembly 40. Alternatively, or additionally, console 200, cooling device 300, and/or second medical device 400 can comprise at least a portion of alert assembly 40.

[193] 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.

[194] 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 ultrasound device 100, 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 ultrasound device 100.

[195] 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 ultrasound 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, stimulated, and/or otherwise treated), or both.

[196] In some embodiments, system 10 is configured to differentiate between a first tissue type and a second tissue type. For example, image data collected using ultrasound device 100 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.

[197] In some embodiments, one or more components of system 10 are configured to be calibrated. For example, one or more components of ultrasound device 100 can be configured to be calibrated.

[198] In some embodiments, system 10 includes one or more pharmaceutical agents, contrast agents, 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 ultrasound device 100.

[199] In some embodiments, system 10 includes one or more additional medical devices, second medical device 400 shown. Second medical device 400 can comprise a device selected from the group consisting of a cystoscope; a photoacoustic device; a lithotripsy device; a brachytherapy device; a fluid delivery device; a stimulation device (e.g., when ultrasound device 100 is configured to assist in the placement of the stimulation device); an implantable device (e.g., when ultrasound device 100 is configured to assist in the implantation of the implantable device); and combinations of these.

[200] In some embodiments, system 10 includes one or more assemblies for robotically manipulating ultrasound device 100 and/or another component of system 10, robotic manipulator assembly 500 shown. Robotic manipulator 500 can be configured to rotate ultrasound device 100, such as to create a 360° image of tissue (e.g., a 2D or 3D image of tissue) and/or at least an image of a sector of tissue of more than 180°. Robotic manipulator 500 can be configured to rotate, translate, and/or otherwise move ultrasound device 100 prior to, during, and/or after imaging, treatment (e.g., ablation and/or stimulation), and/or other procedure is performed by device 100. In some embodiments, robotic manipulator 500 is configured to perform a set of movements (e.g., translations and/or rotations) of ultrasound device 100 during an imaging procedure, such as to create a set of images that can be “stitched” together to create a 3D image.

[201] In some embodiments, system 10 includes one or more additional imaging devices, second imaging device 600 shown. Second imaging device 600 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 one or more images using ultrasound device 100 and to produce at least a second set of one or more images using second imaging device 600. In these embodiments, system 10 can be further configured to compare and/or combine the first set of images with the second set of images. System 10 can be configured to produce a set of one or more images before any ablation or other treatment energy delivery and/or after any ablation or other treatment energy delivery (e.g., to perform closed-loop ablation or other treatment, and/or to assess the efficacy of an ablation or other treatment).

[202] 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 ultrasound device 100 for creating images, delivering treatment energy (e.g., ablation energy, stimulation energy, and/or other treatment 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 ultrasound device 100 is inserted. In some embodiments, accessory device 700 comprises a first accessory device 710, a second accessory device 720, or both.

[203] As described herein, system 10 can comprise one or more functional elements, functional element 99 shown. For example, ultrasound device 100 can comprise functional element 199, console 200 can comprise functional element 299, and/or another component of system 10 can comprise a functional element 99. A functional element 99 can comprise: one, two, or more sensors; one, two, or more transducers; and/or one, two, or more other functional elements and/or functional assemblies. [204] 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 (e.g., confirm the proper functionality) of one or more of the transducers 155 and/or other components of ultrasound array 150. The assessment can comprise an assessment of one or more reflections received from a wall (e.g., an outer wall) of shaft assembly 130 (e.g., transmitted and/or received by the one or more transducers 155). When one or more malfunctioning transducers 155 are identified (e.g., confirmed via a system diagnostic procedure), system 10 can: enter an alert state; disable function of ultrasound array 150; allow function of ultrasound array 150 while deactivating or otherwise compensating for the one or more malfunctioning transducers 155; and/or perform another alert function and/or compensation function. System 10 can be configured to perform various system diagnostic procedures.

[205] In some embodiments, system 10 is configured to determine an “angle of orientation” of ultrasound array 150 (e.g., an angle of orientation of all or a portion of ultrasound array 150), such as an angle of orientation of ultrasound array 150 relative to a portion of ultrasound device 100. Ultrasound device 100 can comprise a wall (e.g., an outer or other wall of shaft assembly 130), and the angle of orientation can be determined based on a reflection of ultrasound received from the wall (e.g., sent and received by one or more transducers 155). 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.

[206] System 10 and ultrasound device 100 can be constructed and arranged such that at least a distal portion of ultrasound device 100 can be inserted into the patient by an operator (e.g., a clinician), and ultrasound array 150 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 150 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 device 100).

[207] System 10 and ultrasound device 100 can be configured to produce one or more multi-dimensional images (e.g., 2D and/or 3D images) of tissue, and each multi-dimensional 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 device 100 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, an automated movement or semi -automated movement (e.g., a movement made automatically or semi-automatically, respectively, by robotic manipulator assembly 500) of device 100 is performed (e.g., during image capture) in order to create multi-dimensional images of tissue. In some embodiments, the movement (e.g., rotation, translation, or both) is performed based on movement-related signals provided by a functional element of system 10 comprising a sensor (e.g., an accelerometer, a gyroscope, and the like). In some embodiments, robotic manipulator assembly 500 is used to rotate and/or translate device 100 to create multi-dimensional images. In some embodiments, a combination of a movement of device 100 by an operator, and movement of device 100 by robotic manipulator assembly 500, 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). 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 device 100 while ultrasound array 150 is positioned (e.g., rotated and/or translated) within the prostatic urethra. Ultrasound device 100 (e.g., at least a distal portion of device 100 configured for insertion into a patient) can comprise one or more flexible portions (e.g., flexible segments) such that device 100 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 device 100 comprises a rigid segment (e.g., a rigid segment within which ultrasound array 150 is positioned), such as a rigid segment that has a flexible segment on each end of the rigid segment. Ultrasound device 100 can comprise one or more components (e.g. one or more components of shaft assembly 130) of sufficient torsional strength to allow rotation (e.g., smooth rotation) within the patient conduit, such as to effectively create a multi-dimensional image.

[208] Ultrasound device 100 can comprise multiple arrays, as described herein, such as an ultrasound array 150 comprising a first array 150a and a second array 150b. A functional element 199 can comprise a mechanical assembly configured to attach first array 150a to second array 150b. The functional element 199 comprising a mechanical assembly can be configured to transition between a first state in which the first array 150a and the second array 150b are flexibly connected (e.g. to allow safe and effective translation of device 100 in a conduit of the patient), and a second state in which the first array 150a and the second array 150b are rigidly connected (e.g., a rigid condition in which one or more portions of array 150 are at a known angle of orientation relative to each other or another portion of device 100). In these embodiments, the functional element 199 comprising a mechanical assembly can comprise a shape memory component, a mechanical linkage, or both.

[209] 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: automatically position and/or reposition ultrasound array 150; and/or allow an operator to manually position and/or reposition ultrasound array 150. In some embodiments, one or more tissue landmarks are used by system 10 to create a treatment plan (e.g., an automated treatment plan or other treatment plan created via algorithm 55 of system 10). 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 device 100, such as to track the progress of the treatment. System 10 can be configured to continuously or at least repeatedly confirm proper positioning of device 100 during ablation, stimulation, 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.

[210] As described herein, ultrasound device 100 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 or otherwise proximate the bladder. In some embodiments, second imaging device 600 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.

[211] System 10 (e.g. using ultrasound device 100) can be configured to perform a biopsy procedure on the patient. For example, second medical device 400 can comprise a biopsy collection device and system 10 can be configured to collect the biopsy via image data provided by ultrasound device 100. System 10 can be configured to perform a biopsy in various configurations.

[212] 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. As described herein, ultrasound device 100 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 create a set of one or more images during and/or after insertion through the body conduit, and to optimize this set of images.

[213] System 10 can be configured (e.g., via ultrasound device 100 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 150. 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 device 100; determine one or more ultrasound delivery parameters used by device 100 to perform an ablation and/or other tissue treatment; and/or calibrate one or more portions of system 10 (e.g., an imaging-related portion, an energy delivery-related portion, or both).

[214] As described herein, ultrasound device 100 can be configured to deliver ultrasound to treat a patient (e.g., to ablate, stimulate, 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 ultrasound, such as a simulation of heat propagation based on: ultrasound delivery parameters; parameters of ultrasound device 100; and/or parameters of the tissue and other material proximate ultrasound array 150 during the delivery of the ultrasound. System 10 can be configured to simulate the heat propagation based on: measurement of tissue attenuation using ultrasound images 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) taken before and during the delivery of the 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 one or more properties of tissue or otherwise related to tissue, such as one or more tissue-related properties selected from the group consisting of: absorption; perfusion; backscatter; temperature; elasticity; displacement (e.g., as caused by energy delivery); intensity distribution; other tissue properties that can change during the treatment; and combinations of these. System 10 can be configured to monitor one or more parameters of ultrasound transducers 155, 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, such as when system 10 is further configured to perform the monitoring of the progress of the treatment based on the collected image data. 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 image intensity statistics technique used by system 10 (e.g., to evaluate tissue changes over time) can be performed for one or more localized regions of an image, such as a “neighborhood” comprising a grid of pixels, such as a 5x5, 5x11, 11x21, or 21x11 grid of pixels. In some embodiments, a change in a tissue characteristic (e.g., a significant change in a tissue characteristic) correlates to: a local mean intensity change of at least IdB, 5dB, or lOdB; a local intensity standard deviation of the intensity change of at least O. ldB, 0.5dB, or IdB; a local median intensity change of at least IdB, 5dB, or lOdB; a local minimum intensity change of at least IdB, 5dB, or lOdB; a local maximum intensity change of at least IdB, 5dB, or lOdB; a local intensity skewness change of at least O.ldB, 0.5dB, or IdB; and/or a local intensity kurtosis change of at least 0. IdB, 0.5dB, or IdB. In some embodiments, system 10 is configured to perform a dimensionality reduction technique (e.g., PCA, ICA, SVD) to decrease the number of metrics (e.g., from 7 or more independent metrics to 4 or less optimized metric combinations). The monitoring of the treatment performed by system 10 can comprise: capturing a first set of one or more images prior to the treatment; capturing a second set of one or more images 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. System 10 can be configured to produce a visual output (e.g. provided by user interface 106 or other user interface 60) in which tissue properties representing the effects of an ablation, stimulation, or other treatment are highlighted, color-coded, segmented, and/or otherwise graphically differentiated.

[215] As described herein, system 10 can be configured to perform various treatment procedures comprising delivery of ultrasound. 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, such as: pressure zones; ablation tissue volumes; ablation tissue volumes relative to total volumes; stimulation tissue volumes; and/or stimulation tissue volumes relative to total tissue volumes.

[216] In some embodiments, and as described in reference to Fig. 5A-5C and otherwise herein, system 10 is configured to operate ultrasound array 150 using one or more operational parameters (e.g., fractional bandwidth, frequencies of operation, cell quantity and dimensionality, and the like) above a minimum and/or below a maximum (e.g., within a range), such as to improve plate displacement uniformity (e.g., plate 1557 displacement uniformity within a CMUT element 1551 as described herein), prolong useful life of array 150, prevent damage to array 150, and/or otherwise improve performance of array 150. For example, system 10 can be configured to operate ultrasound array 150 with a fractional bandwidth of at least 65%, of no more than 100%, or both, and with a ratio of maximum plate displacement to median plate displacement of no more than 150% (1.5:1). Alternatively, or additionally, system 10 can be configured to operate ultrasound array 150 at a frequency that is at least 80%, no more than 100%, or both, of the center frequency of the one or more ultrasound transducers 155, and during delivery of energy to produce image data, operate the ultrasound array 150 with a frequency that is at least 80%, no more than 160%, or both, of the center frequency of the one or more ultrasound transducers. In some embodiments, system 10 is configured to perform harmonic imaging with a transmit frequency of approximately 4MHz and a receive frequency of approximately 8MHz. In some embodiments, one or more transducers 155 of array 150 each comprise a CMUT element 1551, each element 1551 comprising an X by Y arrangement of CMUT cells 1552, where X is 1 cell 1552 or 2 cells 1552, and Y is at least 4 cells 1552.

[217] In some embodiments, ultrasound array 150 comprises CMUT 1551, as described herein, and array 150 is configured to have a particular performance (e.g., pressure output and useful life), such as when array 150 and CMUT element 1551 are configured to produce a surface pressure of at least IMPa peak-to-peak for a time period of at least 15 minutes, 20 minutes, or 30 minutes, such as when operated at a frequency of at least 3MHz, of no more than 7MHz, or both, and/or with a duty cycle of at least 70%, 80%, and/or 90%. In these embodiments, ultrasound array 150 can utilize a maximum AC + DC transmit voltage of no more than 220V, and/or array 150 can have a fractional bandwidth of at least 65%.

[218] Referring now to Fig. 2, a schematic view of a system comprising an ultrasound device and a robotic manipulator assembly is illustrated, consistent with the present inventive concepts. System 10 of Fig. 2 can be of similar construction and arrangement as system 10 of Fig. 1 and/or 1A, and/or otherwise described herein. System 10 of Fig. 2 includes robotic manipulator assembly 500 which is operably attached to ultrasound device 100. Robotic manipulator assembly 500 can be configured to robotically translate (e.g., advance and/or retract), rotate, steer, and/or otherwise manipulate ultrasound device 100. Additionally, or alternatively, robotic manipulator assembly 500 can be configured to robotically manipulate another component of system 10.

[219] Ultrasound device 100 can comprise shaft assembly 130 that extends distally from handle 110. Ultrasound array 150 can be located in a distal portion of shaft assembly 130, as shown. Shaft assembly 130 can comprise one or more elongate shafts, shaft 131. Shaft assembly 130 can include one or more passageways and/or lumens therethrough, such as guidewire lumen 132 that can extend from a proximal portion of shaft 131 to a distal portion (e.g., exiting the distal end) of shaft 131. Guidewire lumen 132 can be constructed and arranged to slidingly receive a guidewire and/or other elongate device. Additionally, or alternatively, shaft assembly 130 can include one or more other lumens, such as lumen 135 described herein. Shaft assembly 130 can include one or more conduits and/or linkages, such as communication pathway 133 shown. Communication pathway 133 can comprise one or more communication pathways that operably connect one or more components of ultrasound device 100 to one or more components of robotic assembly 500 and/or one or more components of console 200 (connections not shown). Communication pathway 133 can comprise one or more mechanical linkages, such as a linkage configured to steer a portion of shaft assembly 130, and/or an electrical conduit, such as one or more wires configured to operably connect a component (e g., ultrasound array 150) to a controller, such as a controller of robotic assembly 500 and/or console 200, as described herein.

[220] Ultrasound array 150 can include transducer 155 that can be located in a distal portion of shaft assembly 130, as shown. Ultrasound array 150 can include acoustic lens 151, that can be located proximate transducer 155 and configured to focus and/or otherwise manipulate ultrasound signals propagating toward and/or from transducer 155. In some embodiments, ultrasound device 100 comprises a sensor 125, such as temperature sensor 125a shown. Temperature sensor 125a can be configured to provide a signal related to the temperature of a portion of shaft assembly 130, ultrasound array 150, and/or tissue surrounding shaft assembly 130. Ultrasound device 100 can include cooling assembly 160 that can be located within a distal portion of shaft assembly 130, such as proximate ultrasound array 150. Cooling module 160 can be configured to cool ultrasound array 150 and/or tissue surrounding shaft assembly 130. In some embodiments, cooling assembly 160 includes one or more cooling elements, such as heat exchanger 161. Heat exchanger 161 can comprise a passive and/or an active heat exchanger, such as a fluid cooled heat exchanger and/or a thermoelectric heat exchanger. Cooling assembly 160 can include one or more passageways for transferring energy (e.g., thermal energy) from heat exchanger 161, thermal conduit 162 shown. In some embodiments, thermal conduit 162 comprises one, two, or more fluid conduits configured to carry circulating cooling fluid to and/or from heat exchanger 161. [221] In some embodiments, handle 110 is configured to operably attach to robotic assembly 500, such that positioning and/or other manipulation of ultrasound device 100 can be performed by robotic assembly 500, as described herein. Robotic assembly 500 can include a subassembly for manipulating the shape and/or steering one or more portions of shaft assembly 130, steering subassembly 510. Steering subassembly 510 can be configured to actuate one or more steering wires or other linkages, such as communication pathways 133 configured as mechanical linkages for manipulation of shaft assembly 130. Robotic assembly 500 can include one or more subassemblies for manipulating the 3D positioning of ultrasound device 100, such as translating subassembly 520 and/or rotating subassembly 530, each shown. Translating subassembly 520 can include one or more motive elements, translation motor 525 shown, and/or one or more encoders or sensors, translation encoder 526 shown. Rotating subassembly 530 can include one or more motive elements, rotation motor 535 shown, and/or one or more encoders or sensors, rotation encoder 536 shown.

[222] Referring now to Fig. 3, a schematic view of an ultrasound array is illustrated, consistent with the present inventive concepts. Ultrasound array 150 of Fig. 3 can be of similar construction and arrangement as ultrasound array 150 described in reference to Fig. 1 and/or Fig. 1A, and/or otherwise herein. Ultrasound array 150 can include one or more ultrasound transducers, such as transducers 155a and 155b shown. Each transducer 155 can comprise a CMUT transducer element, CMUT element 1551 shown, each including an array of CMUT cells, cells 1552 shown. Cells 1552 can be arranged in rows and columns, such as four columns of ten cells 1552 each, as shown. Each CMUT element 1551 can comprise more or less rows and/or more or less columns of cells 1552 than shown in Fig. 3, for example as few as a single cell 1552 (e.g., a 1x1 grid of cells 1552), and/or such as at least 2 rows each of at least 4 cells, for example two rows each of approximately 39 cells.

[223] As shown and described herein, each CMUT element 1551 can comprise many cells (e.g., cells 1552 of CMUT element 1551 shown). Each CMUT cell 1552 can comprise a plate (e.g., top plate 1557 described herein) that can be configured to deflect in response to an electrical signal, such as to create a pressure wave. In some embodiments, the ratio of maximum plate 1557 displacement to median plate 1557 displacement is maintained to a ratio of no more than 150% (1.5: 1). In some embodiments, the plate displacement of different cells 1552 within an element 1551 can be out of phase with respect to each other. The maximum pressure that an element 1551 can produce may be limited by the maximum plate displacement that can be achieved without a plate making contact with (e.g., striking) the bottom of the cell 1552. A plate making contact with the bottom of a cell 1552 can cause one or more reliability issues, such as issues due to charging and/or electrical breakdown. For example, charging is a phenomenon where a static charge is trapped in an insulator layer (e.g., insulator layer 1554 described herein) between the top and bottom electrodes (e.g., top plate 1557 and substrate 1553, respectively, each as described herein). The trapped charge can create an effective DC voltage on the cell (e.g., cell 1552 shown), causing changes in the cell behavior during operation. When the plate does not make contact with the bottom of cell 1552, the electric field is distributed between the gap (e.g., chamber 1556 described herein) and the insulating layer. However, when the plate comes into contact with the bottom of the cell, the electric field becomes concentrated within the insulating layer. This intensifies the charging effect, and can lead to breakdown of the cell. When the plate displacement of cells 1552 of an element 1551 is non-uniform (e.g., and results in undesired contact between the plate and bottom of the cell), the maximum output pressure of the element 1551 can be greatly reduced due to the plates of cells 1552 with larger plate displacement making contact with the bottom of the cell while the average displacement across the cells of the element 1551 is much less than the full gap height (e.g., the total physical distance from the undeflected plate to the bottom of the cell).

[224] Array 150 can be configured to avoid one or more issues or other limitations associated with negative effects of “mutual acoustic impedance”. Mutual acoustic impedance (or “mutual impedance”) describes the acoustic coupling between cells in a transducer (e.g., cells 1552 of an element 1551). It may also be thought of as applying pressure at one cell that results in movement of another cell. During operation of a CMUT cell (e.g., where the plate of the cell is vibrated), an acoustic force is loaded on the plate. This acoustic force is proportional to the plate's velocity and the acoustic impedance. The acoustic impedance is the sum of two components: the cell’s self-acoustic impedance, which is influenced by the plate's radius; and the properties of the surrounding medium. Mutual acoustic impedance depends on the distance between two or more cells, the velocities of the plates of the cells, and the properties of the surrounding medium. The mutual acoustic impedance can vary based on the distance between a cell 1552 and neighboring cells. As a result, the mutual acoustic impedance between cells differs among cells within element 1551. This variation in acoustic impedance across cells leads to differences in their dynamic responses, causing variations in the amplitude and phase of the plate's vibration and non-uniformity of plate displacement.

[225] In some embodiments, non-uniformity in plate displacement of a CMUT element 1551 arises from acoustic interactions between cells 1552 (e.g., caused by the mutual impedance of the cells). For example, a pressure wave from a first cell 1552 can affect the plate displacement of a second cell 1522, (e.g., a cell 1552 neighboring the first cell 1552). In some embodiments, the maximum voltage applied to a CMUT element 1551 can be limited to a voltage that is less than the voltage that would cause the plate with the greatest displacement to strike or otherwise make contact with the bottom of the associated cell 1552. This operating limitation (e.g., a limitation that is caused by the non-uniformity of the plate displacement of a CMUT element 1551) can reduce the applicable voltage applied to a CMUT element 1551 to a relatively low voltage, thus limiting the average plate displacement of the CMUT element 1551, and/or limiting the output pressure of the element 1551.

[226] The cell non-uniformity issue is exacerbated when operating in a HIFU mode because quasi-continuous wave operation allows for the interaction between cells (e.g., cells 1552) to fully develop and to establish non-uniform displacement over at least a portion of the element (e.g., CMUT element 1551), over a group of elements, and/or over at least a portion of an array (e.g., array 150). In some embodiments, HIFU operation of a CMUT element (e.g., CMUT element 1551) is performed at a high voltage that results in a high electric field in the insulator layer (e.g., insulator layer 1554 described herein) and increased potential for the failure of one or more cells 1552 relative to the potential for failure of the entire CMUT element 1551.

[227] Referring now to Fig. 4, a sectional schematic view of a CMUT cell is illustrated, consistent with the present inventive concepts. CMUT cell 1552 of Fig. 4 can be of similar construction and arrangement as the associated components of system 10 described in reference to Fig. 1 and/or Fig. 1 A, and/or otherwise herein. A CMUT element, such as CMUT element

1551 described herein, can comprise an array of cells 1552, such as cells 1552 that are constructed and arranged similar to cell 1552 shown in and described in reference to Fig. 4. Cell

1552 can comprise multiple layers, such as multiple layers that are manufactured (e.g., manufactured via deposition, consumption, or other silicon fabrication processes) onto a substrate, such as substrate 1553 shown. Cell 1552 can comprise, one or more insulating layers, such as insulator layer 1554 shown, one or more walls surrounding a void, such as walls 1555 surrounding chamber 1556, each shown, and/or one or more top layers enclosing chamber 1556, such as top plate 1557 and/or metal layer 1558, each shown.

[228] In some embodiments, the thickness of insulator layer 1554 of CMUT cell 1552 is chosen to improve its robustness to breakdown (e.g., to decrease the likelihood of cell 1552 failing when an electrical signal is applied to the cell). Insulator layer 1554 can comprise a layer of insulating material between the top and bottom electrode of the CMUT cell (e.g., a layer of insulating material between substrate 1553 and top plate 1557, as shown). Insulator layer 1554 can be composed of silicon dioxide, such as silicon dioxide that is fabricated using thermal oxidation, or can be composed of another dielectric material. In some embodiments, insulator layer 1554 comprises silicon dioxide that is fabricated using other methods, such as silicon dioxide that is deposited using chemical vapor deposition. In some embodiments, insulator layer 1554 is composed of other dielectric materials, such as silicon nitride. In some embodiments, insulator layer 1554 is composed of two or more layers, such as two or more layers each comprising different materials. In some embodiments, insulator layer 1554 is positioned on the bottom of cell 1552 (e.g., on the top surface of substrate 1553, as shown) and/or on the bottom of the top plate (e.g., on the bottom surface of top plate 1557). In some embodiments, insulator layer 1554 comprises two layers that are positioned on both the top surface of substrate 1553 and the bottom surface of top plate 1557.

[229] Insulator layer 1554 comprises a height (e.g., the thickness of the layer), height Hl shown. Height Hl can be chosen such that cell 1552 will not break down at normal operating voltages, for example even if top plate 1557 makes contact with the bottom of the cell (e.g., the bottom of chamber 1556). Even if the system is designed so that no CMUT plate makes contact with the bottom of the cell under normal operating conditions, unexpected events may occur which can cause the plate to make contact with the bottom of the cell. It is advantageous if the CMUT can tolerate these events to decrease the chances of damage, degradation, or failure during operation. The breakdown voltage of the insulator layer material can be configured (e.g., chosen) to avoid breakdown. A set of measurements over multiple samples can be performed to find the distribution of the associated breakdown voltages (e g., an experimental process performed in the development of ultrasound device 100). The insulator layer thickness can then be chosen so that the electric field in the insulator is low enough to prevent breakdown with high probability. In some embodiments, limiting the maximum electric field within insulator layer 1554 can reduce the likelihood of stiction by preventing current flow through insulator layer 1554 when top plate 1557 makes contact with the bottom of chamber 1556.

[230] The drive signal of the CMUT can comprise a combined AC and DC voltage. In some embodiments, there is a set of AC and DC voltage combinations which collectively result in the maximum operating voltages. The thickness of insulator layer 1554 can be chosen to tolerate the largest combination of AC and DC voltage in this set. There can be several limitations on the maximum operating voltage of the CMUT. The maximum operating voltage(s) can be determined by an analysis of: the voltage that will cause a plate to strike or otherwise make contact with the bottom of a cell; the limits of the electronics systems that produce the voltages; the voltage ratings of other system components; and combinations of these.

[231] In some embodiments, increasing the thickness of insulator layer 1554 can reduce the performance of cell 1552. For example, when other dimensions remain constant, increasing the thickness of insulator layer 1554 can reduce the transmit and receive sensitivity, which can increase the voltage required to produce a desired output pressure. In some embodiments, to increase the transmit and receive sensitivity, the height of chamber 1556 (e.g., the separation distance between insulator layer 1554 and top plate 1557) can be decreased (e.g., to compensate for increased thickness of insulator layer 1554), such that the “pull-in voltage” is not changed. The pull-in voltage is the DC voltage at which top plate 1557 is pulled down to the bottom of the cell (e.g., such that top plate 1557 contacts insulator layer 1554). This configuration can keep the operating voltage roughly the same, but reduces the maximum plate displacement and therefore the maximum output pressure. In some embodiments, the thickness of insulator layer 1554 is selected to be at least the thickness required to reliably prevent breakdown of cell 1552, but no more than 50% greater than the required thickness, such as approximately 25% greater.

[232] In some embodiments, with all other dimensions of cell 1552 held constant, as the thickness of insulator layer 1554 increases, the transmit sensitivity and receive sensitivity both decrease, and the breakdown voltage increases. If the pull-in voltage of cell 1552 remains constant, as the thickness of insulator layer 1554 increases, the maximum pressure of cell 1552 can decrease, and the breakdown voltage can increase. [233] In some embodiments, the thickness of insulator layer 1554 is non-uniform. For example, one or more regions of the insulator layer 1554 can be thinner than the thickness required to prevent breakdown. In some embodiments, these thinner regions do not increase the risk of the breakdown, for example as long as top plate 1557 makes contact with a thicker region of insulator layer 1554 when it makes contact with the bottom of the cell. Additionally, or alternatively, there can be regions of insulator layer 1554 that are thicker than a minimum thickness required to prevent breakdown, for example when there is space for a thicker insulator layer without obstructing top plate 1557. The breakdown voltage of a CMUT cell (e g., cell 1552) can vary significantly depending on whether a positive or negative voltage is applied to the top electrode relative to the bottom electrode. In some embodiments, cell 1552 can be operated with the polarity associated with the higher breakdown voltage. For example, if top plate 1557 and substrate 1553 are both composed of p-type silicon, a positive voltage can be used to maximize the breakdown voltage.

[234] Referring now to Figs. 5A through 5C, first and second sectional views of CMUT elements comprising multiple CMUT cells, and a graph of output pressure versus frequency are illustrated, respectively, consistent with the present inventive concepts. CMUT element 1551 of Figs. 5 A and 5B can be of similar construction and arrangement as CMUT element 1551 described in reference to Fig. 1 and/or Fig. 1A, and/or otherwise herein. A CMUT element, such as CMUT element 1551 described herein, can comprise an array of cells 1552, such as cells 1552 that are constructed and arranged similar to cell 1552 described in reference to Fig. 4. Figs. 5A and 5B illustrate the concept of cell displacement and phase non-uniformity, as described herein.

[235] For example, Figs. 5 A and 5B illustrate non-uniformity in plate motion that may occur in CMUT cells when transmitting. Figs. 5A and 5B are cross-sectional views through four cells, cells 1552a-d, of the same array element 1551 (i.e., the same array is shown in Fig. 5A and Fig. 5B). The cross section is along the azimuth direction (e.g., across the width of element 1551).

[236] Ideally, cells 1552a-d should move with the same amplitude and phase. However, the amplitude and phase may differ substantially between cells 1552 in actual use, as shown in Figs. 5 A and 5B. Fig. 5 A illustrates a case in which cells 1552a-d do move in phase, but with different amplitudes. Cells 1552a and 1552d can have a greater amplitude than cells 1552b and 1552c, as shown. Fig. 5B illustrates a case where cells 1552a-d have the same amplitude, but different phases. Cells 1552a and 1552d are out of phase with cells 1552b and 1552c. These are examples illustrating non-uniformity that is either related to amplitude or phase. In some embodiments, cells 1552 may have both amplitude and phase non-uniformity. The pattern of non-uniformity may also be different than illustrated in Figs. 5A and/or 5B. For example, in some embodiments, all four cells 1552a-d may have different amplitudes and/or phases.

[237] Fig. 5C shows an example plot of transmit pressure versus frequency for an example CMUT element 1551 with a center frequency of 5 MHz. Ideally, the pressure would smoothly decrease as moving away from the center frequency. However, due to interactions between cells 1552, in this example, there is a large peak at 3.7 MHz. This peak would not be anticipated by a single-cell model. The frequency response shown in Fig. 5C can exhibit either a prominent peak (e.g., as shown) or a significant dip, depending on the cell distribution within the element.

[238] In some embodiments, system 10 is configured to operate ultrasound array 150 such that the ratio of maximum plate 1557 displacement to median plate 1557 displacement is no more than 150% (1.5: 1). In these embodiments, system 10 can be configured to operate array 150 with a fractional bandwidth of at least 65%, of no more than 100%, or both. During delivery of treatment energy (e.g., ablation energy), system 10 can be configured to operate array 150 within a frequency range that is 80% to 100% of the center frequency of the one or more ultrasound transducers 155, and during delivery of energy to produce image data, system 10 can be configured to operate ultrasound array 150 within a frequency range that is 80% to 160% of the center frequency of the one or more ultrasound transducers 155.

[239] The CMUT design of the present inventive concepts can be operated at frequencies above 4.2 MHz, which avoids the frequency range in which cell-to-cell interactions have a strong effect. This design is an example of a general principle that strong cell-to-cell interaction effects result at frequencies below the center frequency. In some embodiments, CMUTs are configured to operate at frequencies just below (-0-20% below, depending on the design) their center frequency or higher, especially for applications of array 150 with high pressure and long transmit bursts.

[240] For example, in an application of array 150 requiring transmit operation at 5 MHz and 9 MHz, configurations with a center frequency of 7 MHz may not perform well due to strong cell interactions at 5 MHz. Accordingly, array 150 can be operated at a center frequency of 5 MHz or 5.5 MHz, for example.

[241] In various embodiments, CMUT elements (e.g., CMUT element 1551) can be composed of different numbers of cells 1552, such as an X by Y array of cells 1552, where X and Y are both greater than or equal to 1. The number of cells 1552 across the width (azimuth direction, or X dimension) of each element 1551 can be selected to reduce plate displacement non-uniformity.

[242] In some embodiments, the width of element 1551 (e.g., the number of cells 1552 in the X or azimuth direction of element 1551) can be selected based on the following algorithmic process. The pitch of element 1551 (e.g., the periodicity with which element 1551 repeats along the X direction) can be selected to eliminate grating lobes according to the ultrasound frequency and imaging type. For example, linear array imaging requires a pitch approximately equal to the wavelength of sound in the medium (i.e., the material through which the ultrasound energy is traveling), and phased array imaging requires a pitch approximately equal to half this wavelength. In some embodiments, the kerf is selected to be as small as possible given manufacturing limitations and the requirement to electrically isolate neighboring elements from each other. The cell size can be selected to fill as much of the area of element 1551 as possible, allowing for some bonding area between cells 1552, as well as between the outer edges of cells 1552 and the edge of element 1551. The width of the bonding area can be limited by the bonding quality and yield. In some embodiments, the width of each cell 1552 plus bonding area can be roughly the width of element 1551 divided by an integer (e.g., 1, 2, 3, 4, etc.).

[243] When the frequency of an array 150 drive signal is held constant (e.g., when a similar drive signal is delivered to elements 1551 and/or cells 1552 of different configurations), larger cells 1552 generally have a smaller bandwidth, which can limit ultrasound imaging performance. For example, in some embodiments, ultrasound imaging requires wide frequency bandwidth, such as a frequency bandwidth of at least 55%, 62%, and/or 70%. Larger cells 1552 can also exhibit less displacement non-uniformity, which can increase HIFU performance. For example, less displacement non-uniformity can provide better reliability, which can be beneficial for HIFU applications. For dual-mode HIFU and imaging operation, to optimize performance of both the HIFU and imaging operation, cells 1552 should be as large as possible while preserving sufficient bandwidth for imaging, for example at least 65%, or at least 70%, fractional bandwidth. For HTFU applications, since bandwidth is not a concern, the width of cell 1552 is limited by the width of the element (e.g., an element comprising a single cell 1552 in the azimuth direction is possible in some embodiments).

[244] Various illustrative examples of CMUT element designs are described herein. The dimensions described can be derived algorithmically to optimize both imaging and HIFU performance of the element, as described herein. Described hereinbelow are examples for phased arrays with center frequencies of 3 MHz, 6 MHz, and 10 MHz. Various dimensions and specifications of each design are detailed in Table 1 herein. These specifications are described for purposes of providing specific examples, and should not be considered limiting of the scope of the present inventive concepts. For example, variations in kerf, cell-to-cell separation, or other small parameter changes are close enough in behavior to be considered equivalent.

[245] The configurations described hereinbelow are for cells 1552 that are circular. In some embodiments, a similar configuration (e.g., a similar design approach) can be used for cells 1552 with other cell shapes, such as squares, hexagons, and/or other polygons. In the configurations below, the plate thickness (e.g., the thickness of top plate 1557) comprises a thickness that achieves the desired center frequency based on the radius of cell 1552 (e.g., the effective radius).

[246] The algorithmic design approach described herein can be applied to both ID array and 2D array configurations of array 150. For example, 2-cells 1552 across the width of an element 1551 refers to a 2 x N cell configuration of element 1551 in a ID array 150 (e.g., a 1 x N array of elements 1551), and a 2 x 2 cell configuration in a 2D array 150 (e.g., a 2 x N array of elements 1551). As used herein, a ID array 150 has a single line of elements 1551. Each element 1551 consists of a 2D grid of cells 1552. A 2 x N cell configuration refers to a ID array of elements 1551 with 2 cells 1552 in the azimuth direction and N cells 1552 in the elevation direction. As used herein, a 2D array 150 has two or more lines of elements 1551. A 2 x 2 configuration refers to a 2D array of elements 1551, each consisting of a 2 x 2 grid of cells 1552.

[247] In some embodiments, a four-step process can be used to optimize the configuration of CMUT element 1551. First, the pitch of element 1551 is set to half the wavelength of sound in the medium at the center frequency of element 1551. Second, a kerf is selected according to manufacturing tolerances and typical element separation requirements. Third, various cell 1552 designs are generated with 1, 2, or 3 cells 1552 across the width of element 1551, where the design of cell 1552 (e.g., the dimensions) are such that the cells fill as much of the element width as possible. Fourth, the bandwidth of each cell design from the third step can be modeled (e.g., based on the dimension or other specifications of the cell). An optimized cell design can be selected based on the design with the fewest number of cells 1552 across element 1551 (e.g., the cells 1552 with the largest area) that have acceptable bandwidth (e.g., a high enough bandwidth). In some embodiments, the cutoff for acceptable bandwidth may depend on the requirements of the application. In some embodiments, a fractional bandwidth of at least 65%, or at least 70%, can be selected as the cutoff (e.g., threshold of minimum bandwidth). The bandwidth of element 1551 can limit the depth resolution of the ultrasound image created using the element. Larger bandwidth can enable better depth resolution. The required bandwidth can be determined from the depth resolution requirements of the system. The typical fractional bandwidth for imaging is roughly 50-100%. Less than 50% bandwidth can unacceptably limit the depth resolution.

[248] As shown in the table below, based on modeling performed by the applicant, for the 3 MHz configuration, the 2-cell width arrangement is the design with the fewest cells that meet acceptable bandwidth requirements for dual-mode (e.g., imaging and HIFU) operation. For HIFU-only operation, the 1-cell width arrangement can be used. For the 6 MHz design, the 2- cell width arrangement also meets acceptable bandwidth requirements for dual-mode operation. The 1-cell width arrangement can also be used for HIFU-only operation. For the 10 MHz design, the 2-cell width design meets acceptable bandwidth requirements for dual -mode operation. The 1-cell width arrangement can also be used for HIFU-only operation.

[249] Table 1 below also shows frequency ranges that are associated with significant cell- to-cell interaction issues, according to a model that was simulated by the applicant. It illustrates why it is important to choose a configuration of array 150 with a minimized quantity (e.g., the fewest possible number) of cells across the width. For example, when considering 6 MHz operational configurations, a 2-cell design has issues or other limitations in the 2.3 MHz to 4.3 MHz frequency range, so it can operate effectively in a substantial frequency range around its center frequency of 6 MHz. A 3-cell design has cell-to-cell interaction issues or other limitations at frequencies between 1.8 MHz and 5.2 MHz, and at 5.8 MHz. This limitation greatly limits the usable frequency range of the design. Even the center frequency of 6 MHz is very close to a “problem frequency” ( a frequency with undesired behavior) that occurs at 5.8 MHz. The 2-cell design is therefore preferred over the 3-cell design for dual-mode operation even though the bandwidth is lower.

[250] Modeling of cell-to-cell interactions can be used to determine one or more array 150 parameters, such as to quantify performance, but is not required.

[251] Table 1 below also illustrates a general tradeoff between fractional bandwidth and cell-to-cell interaction issues or other limitations. Typically, maximizing bandwidth may be taken as a design goal. However, this approach may not be the best for devices intended for high- pressure, long-burst applications such as HIFU. In these cases, a reduced (e.g., minimum required) bandwidth can be used to minimize issues and other limitations with cell-to-cell interactions. [252] 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.

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Claims

WHAT IS CLAIMED IS:

1. A system for performing a medical procedure on a patient, the system comprising: an ultrasound device comprising an ultrasound array including one or more ultrasound transducers, the ultrasound array configured to emit ultrasound to target tissue of the patient, wherein the system is configured to;

(1) operate the ultrasound array with a fractional bandwidth in the range of 65% to 100%, and with a ratio of maximum plate displacement to median plate displacement of no more than 150%; and/or

(2) during delivery of treatment energy, operate the ultrasound array within a frequency range that is 80% to 100% of the center frequency of the one or more ultrasound transducers.

2. The system according to claim 1 and/or any one or more other claims herein, wherein during the delivery of energy to produce image data, the system is configured to perform harmonic imaging with a transmit frequency of approximately 4MHz and a receive frequency of approximately 8MHz.

3. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to operate the ultrasound array with a ratio of maximum plate displacement to median plate displacement of no more than 150%.

4. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound array is configured to produce a surface pressure of at least IMPa peak-to-peak for a time period of at least 15 minutes, 20 minutes, or 30 minutes.

5. The system according to claim 4 and/or any one or more other claims herein, wherein the ultrasound array is operated at a frequency of at least 3MHz, of no more than 7MHz, or both.

-n-

6. The system according to claim 4 and/or any one or more other claims herein, wherein the ultrasound array is operated with an AC + DC transmit voltage of no more than 220V.

7. The system according to claim 4 and/or any one or more other claims herein, wherein the ultrasound array is operated with a fractional bandwidth of at least 65%.

8. The system according to claim 1 and/or any one or more other claims herein, wherein the medical procedure comprises a diagnostic procedure.

9. The system according to claim 8 and/or any one or more other claims herein, wherein the diagnostic procedure comprises an imaging and/or other diagnostic analysis of the prostate of the patient.

10. The system according to claim 8 and/or any one or more other claims herein, wherein the diagnostic procedure comprises an imaging and/or other diagnostic analysis of an anatomical location of the patient selected from the group consisting of: prostate; uterus; nasal passageway and/or tongue; an organ such as bladder, bone, brain, heart, intestine, kidney, liver, lung, skin, and/or stomach; and combinations thereof.

11. The system according to claim 8 and/or any one or more other claims herein, wherein the diagnostic procedure comprises an imaging and/or other diagnostic analysis of a tissue type selected from the group consisting of: benign prostatic hyperplasia tissue; tumor 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 thereof.

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

13. The system according to claim 12 and/or any one or more other claims herein, wherein the treatment procedure comprises ablation, stimulation, and/or other treatment of the target tissue, wherein the target tissue comprises tissue of the prostate of the patient.

14. The system according to claim 13 and/or any one or more other claims herein, wherein the system is configured to avoid damage to non-target tissue of the patient.

15. The system according to claim 14 and/or any one or more other claims herein, wherein the non-target tissue comprises: tissue of the wall of the urethra, tissue of a seminal vesicle, and/or tissue of the ejaculatory duct.

16. The system according to claim 12 and/or any one or more other claims herein, wherein the treatment procedure comprises ablation, stimulation, and/or other treatment of the target tissue, wherein the target tissue comprises tissue of an anatomical location selected from the group consisting of: prostate; uterus; nasal passageway and/or tongue (e.g., to treat sleep apnea); an organ such as bladder, bone, brain, heart, intestine, kidney, liver, lung, skin, and/or stomach; and combinations thereof.

17. The system according to claim 12 and/or any one or more other claims herein, wherein the treatment procedure comprises ablation, stimulation, and/or other treatment of the target tissue, wherein the target tissue comprises a tissue type selected from the group consisting of: benign prostatic hyperplasia tissue; tumor tissue; tissue associated with a cardiac arrhythmia; tissue associated with sleep apnea and/or blockage of an airway; other abnormal and/or otherwise undesired tissue; and combinations thereof.

18. The system according to claim 12 and/or any one or more other claims herein, wherein the treatment procedure comprises the delivery of ultrasound energy to activate a pharmaceutical and/or other agent; and/or to enhance the efficacy of a pharmaceutical and/or other agent.

19. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to perform a medical procedure comprising the delivery of ultrasound energy to an implant and/or an agent, such as to supply power to and/or otherwise modify the implant and/or agent.

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

21. The system according to claim 20 and/or any one or more other claims herein, wherein the medical procedure comprises diagnosis and treatment of the prostate of the patient.

22. The system according to claim 20 and/or any one or more other claims herein, wherein the treatment procedure comprises ablation, stimulation, and/or other treatment of the target tissue, wherein the target tissue comprises tissue of an anatomical location selected from the group consisting of: prostate; uterus; nasal passageway and/or tongue (e.g., to treat sleep apnea); an organ such as bladder, bone, brain, heart, intestine, kidney, liver, lung, skin, and/or stomach; and combinations thereof.

23. The system according to claim 20 and/or any one or more other claims herein, wherein the treatment procedure comprises ablation, stimulation, and/or other treatment of the target tissue, wherein the target tissue comprises a tissue type selected from the group consisting of: benign prostatic hyperplasia tissue; tumor tissue; tissue associated with a cardiac arrhythmia; tissue associated with sleep apnea and/or blockage of an airway; other abnormal and/or otherwise undesired tissue; and combinations thereof.

24. The system according to claim 20 and/or any one or more other claims herein, wherein the medical procedure comprising both imaging and treating.

25. The system according to claim 24 and/or any one or more other claims herein, wherein the imaging and treating are performed simultaneously, sequentially, or both.

26. The system according to claim 24 and/or any one or more other claims herein, wherein the imaging is configured to produce image data, and wherein the treating is performed based on one or more treatment parameters that are determined based on the produced image data.

27. The system according to claim 26 and/or any one or more other claims herein, wherein the one or more treatment parameters are determined by the system.

28. The system according to claim 1 and/or any one or more other claims herein, wherein the target tissue comprises tissue of the prostate of the patient.

29. The system according to claim 1 and/or any one or more other claims herein, wherein the target tissue comprises tissue at an anatomical location selected from the group consisting of: prostate; uterus; nasal passageway and/or tongue; an organ such as bladder, bone, brain, heart, intestine, kidney, liver, lung, skin, and/or stomach; and combinations thereof.

30. The system according to claim 1 and/or any one or more other claims herein, wherein the target tissue comprises tissue with a tissue type selected from the group consisting of: benign prostatic hyperplasia tissue; tumor tissue; tissue associated with a cardiac arrhythmia; tissue associated with sleep apnea and/or blockage of an airway; other abnormal and/or otherwise undesired tissue; and combinations thereof.

31. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to perform a system diagnostic procedure, such as a diagnostic procedure in which functionality of the one or more ultrasound transducers is assessed.

32. The system according to claim 31 and/or any one or more other claims herein, wherein the ultrasound device comprises a wall, and wherein the assessment is based on a reflection of ultrasound received from the wall.

33. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to determine an angle of orientation of the ultrasound array relative to a portion of the ultrasound device.

34. The system according to claim 33 and/or any one or more other claims herein, wherein the ultrasound device comprises a wall, and wherein the angle of orientation is determined based on a reflection of ultrasound received from the wall.

35. The system according to claim 33 and/or any one or more other claims herein, wherein the system is configured to produce a 3D image, and wherein the 3D image is enhanced based on the determined angle of orientation.

36. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises a distal portion, wherein the system is constructed and arranged to allow an operator to perform an insertion procedure in which the distal portion of the ultrasound device is inserted into the patient by an operator, and wherein the ultrasound array is positioned a desired distance from the target tissue when the insertion procedure is completed.

37. The system according to claim 36 and/or any one or more other claims herein, wherein the system is configured to produce one or more images of tissue of the patient prior to completion of the insertion procedure, and wherein the ultrasound array is positioned at the desired distance based on the one or more images.

38. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to produce one or more multi-dimensional images of tissue, wherein each multi-dimensional image comprises at least a partial circumferential image of tissue, wherein the partial circumferential image represents a sector of tissue of at least 180°.

39. The system according to claim 38 and/or any one or more other claims herein, wherein the system is configured to create the one or more multidimensional images via manual rotation of the ultrasound device by an operator.

40. The system according to claim 38 and/or any one or more other claims herein, wherein the sector comprises a sector of at least 350°.

41. The system according to claim 38 and/or any one or more other claims herein, wherein the system is configured to analyze the one or more multidimensional images and produce at least tissue volume information.

42. The system according to claim 38 and/or any one or more other claims herein, wherein the system is configured to perform diagnostics and/or therapy planning based on the one or more multi-dimensional images.

43. The system according to claim 38 and/or any one or more other claims herein, wherein the one or more multi-dimensional images comprise images of the majority of the patient’s prostate, and wherein the multi-dimensional images are based on ultrasound reflections received while the ultrasound array is positioned within the prostatic urethra.

44. The system according to claim 38 and/or any one or more other claims herein, wherein the ultrasound device comprises one or more flexible segments configured to reduce forces encountered during translation within the prostatic urethra or other patient conduit, and wherein the ultrasound device comprises one or more components comprising sufficient torsional strength to allow smooth rotation of the ultrasound array within the prostatic urethra or other patient conduit.

45. The system according to claim 38 and/or any one or more other claims herein, wherein the ultrasound array comprises a first array and a second array connected by a mechanical assembly, and wherein the mechanical assembly is configured to transition between a first state in which the first array and the second array are flexibly connected and a second state in which the first array and the second array are rigidly connected.

46. The system according to claim 45 and/or any one or more other claims herein, wherein the mechanical assembly comprises a shape memory component and/or a mechanical linkage.

47. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to: automatically identify one or more tissue landmarks; and/or allow an operator to manually identify one or more tissue landmarks, wherein the landmark identification is used to: automatically position and/or reposition the ultrasound array; and/or allow an operator to manually position and/or reposition the ultrasound array.

48. The system according to claim 47 and/or any one or more other claims herein, wherein a tissue landmark comprises the verumontanum.

49. The system according to claim 47 and/or any one or more other claims herein, wherein the system is configured to continuously and/or intermittently image tissue during a treatment performed using the ultrasound device, such as to track the progress of the treatment and/or to ensure proper location of the ultrasound array during the treatment.

50. The system according to claim 49 and/or any one or more other claims herein, wherein the system is configured to track the progress of the treatment and/or ensure proper location of the ultrasound array during the treatment by monitoring changes in the tissue being treated.

51. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises a distal portion configured for insertion through the urethra, and wherein the system is configured to image tissue of the bladder and/or locations within the bladder.

52. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device and/or another component of the system is configured to perform a biopsy procedure on the patient.

53. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises a distal portion configured for insertion through a body lumen, wherein the system is configured to create a set of one or more images during and/or after insertion through the body lumen, and wherein the system is configured to optimize the set of one or more images.

54. The system according to claim 53 and/or any one or more other claims herein, wherein the system is configured to perform the optimization using harmonic imaging.

55. The system according to claim 53 and/or any one or more other claims herein, wherein the body lumen comprises the prostatic urethra.

56. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to determine one or more tissue characteristics.

57. The system according to claim 56 and/or any one or more other claims herein, wherein the system is configured to determine the tissue characteristics based on attenuation of ultrasound delivered by the ultrasound array.

58. The system according to claim 56 and/or any one or more other claims herein, wherein the system is configured to use the determined tissue characteristics to: predict the efficacy of an ablation, stimulation, and/or other tissue treatment; determine ultrasound delivery parameters used to perform an ablation, stimulation, and/or other tissue treatment; and/or calibrate an imaging-related portion, an energy deli very -related portion, and/or other portion of the system.

59. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device is configured to deliver ultrasound to treat the patient, and wherein the system is configured to monitor the progress of the treatment.

60. The system according to claim 59 and/or any one or more other claims herein, wherein the treatment comprises ablation of tissue.

61. The system according to claim 59 and/or any one or more other claims herein, wherein the system is configured to perform the monitoring of the progress of the treatment by simulating heat propagation that results from the delivery of the ultrasound.

62. The system according to claim 61 and/or any one or more other claims herein, wherein the system is configured to simulate the heat propagation based on: ultrasound delivery parameters; parameters of the ultrasound device; and/or parameters of the tissue and other material proximate the ultrasound array during the delivery of the ultrasound.

63. The system according to claim 61 and/or any one or more other claims herein, wherein the system is configured to simulate the heat propagation based on: measurement of tissue attenuation using ultrasound images produced by the system.

64. The system according to claim 63 and/or any one or more other claims herein, wherein the system is configured to measure the tissue attenuation via an analysis of signal -to-noise ratio versus depth.

65. The system according to claim 64 and/or any one or more other claims herein, wherein the analysis comprises an analysis of data taken before and during the delivery of the ultrasound energy of the treatment.

66. The system according to claim 59 and/or any one or more other claims herein, wherein the system is further configured to provide a confidence range associated with the monitoring of the progress of the treatment.

67. The system according to claim 59 and/or any one or more other claims herein, wherein in the monitoring of the treatment, the system is configured to account for changes in one or more properties of tissue or otherwise related to tissue selected from the group consisting of: absorption; perfusion; backscatter; temperature; elasticity; displacement; intensity distribution; other tissue properties that can change during the treatment; and combinations thereof.

68. The system according to claim 59 and/or any one or more other claims herein, wherein the system is configured to monitor one or more parameters of the ultrasound transducers, and wherein the system is configured to perform the monitoring of the progress of the treatment based on the ultrasound transducer parameters.

69. The system according to claim 59 and/or any one or more other claims herein, wherein the system is configured to collect image data, and wherein the system is configured to perform the monitoring of the progress of the treatment based on the collected image data.

70. The system according to claim 69 and/or any one or more other claims herein, wherein the system uses a local image intensity statistics technique to evaluate changes in tissue over time.

71. The system according to claim 70 and/or any one or more other claims herein, wherein the collected image data comprises images taken prior to the treatment, during the treatment, and after the treatment.

72. The system according to claim 70 and/or any one or more other claims herein, wherein the local image intensity statistics technique includes: extracting local image statistics.

73. The system according to claim 72 and/or any one or more other claims herein, wherein the local image statistics comprise: local means; local standard deviations; local extrema; local kurtosis; local skewness; and/or local higher-order standardization moments.

74. The system according to claim 70 and/or any one or more other claims herein, wherein the image intensity statistics technique includes: principal component analysis; singular value decomposition; and/or other feature extraction and/or selection techniques.

75. The system according to claim 59 and/or any one or more other claims herein, wherein the monitoring of the treatment comprises: capturing a first set of one or more images prior to the treatment; capturing a second set of one or more images 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.

76. The system according to claim 75 and/or any one or more other claims herein, wherein the system is configured to produce a visual output in which tissue properties representing the effects of the treatment are highlighted, color-coded, segmented, and/or otherwise graphically differentiated.

77. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to perform a treatment procedure comprising delivery of ultrasound, wherein the system is further configured to produce a treatment log representing treatment parameters and/or treatment results.

78. The system according to claim 77 and/or any one or more other claims herein, wherein the treatment log comprises a comparison of tissue intended to be treated and actual tissue treated.

79. The system according to claim 77 and/or any one or more other claims herein, wherein the system is configured to produce the treatment log prior to the completion of the treatment procedure.

80. The system according to claim 77 and/or any one or more other claims herein, wherein the treatment log comprises an analysis of: pressure zones; ablation tissue volumes; ablation tissue volumes relative to total tissue volumes; stimulation tissue volumes; and/or stimulation tissue volumes relative to total tissue volumes.

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

82. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises 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 thereof.

83. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises a distal portion that is constructed and arranged to be inserted into and/or through the urethra of the patient.

84. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises a distal portion that is configured to be inserted into and/or through one or more lumens, openings, and/or other body conduits of a patient 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 thereof.

85. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device further comprises a thermally-insulative layer surrounding at least a portion of the ultrasound array.

86. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises an expandable anchoring element configured to anchor the ultrasound array relative to the target tissue.

87. The system according to claim 86 and/or any one or more other claims herein, wherein the expandable anchor comprises an inflatable balloon.

88. The system according to claim 86 and/or any one or more other claims herein, wherein the expandable anchor is configured to be expanded in the bladder of the patient.

89. The system according to claim 86 and/or any one or more other claims herein, wherein the ultrasound device comprises a removable sleeve, and wherein the removable sleeve comprises the expandable anchor.

90. The system according to claim 89 and/or any one or more other claims herein, wherein the removable sleeve comprises a thermally-insulative layer.

91. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises one rigid segment and one or more flexible segments.

92. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises a proximal portion, a distal portion, and a lumen extending from the proximal portion to the distal portion.

93. The system according to claim 92 and/or any one or more other claims herein, wherein the lumen is constructed and arranged to slidingly receive an elongate device comprising a diagnostic device, a treatment device, or both.

94. The system according to claim 93 and/or any one or more other claims herein, wherein the elongate device comprises a cystoscope and/or a photoacoustic device.

95. The system according to claim 92 and/or any one or more other claims herein, wherein the system is configured to deliver a fluid through the lumen to achieve and/or enhance acoustic coupling between the ultrasound array and the target tissue.

96. The system according to claim 92 and/or any one or more other claims herein, wherein the system is configured to deliver a fluid through the lumen to cool at least the ultrasound array.

97. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises a proximal portion and a lumen extending from the proximal portion, and wherein delivery of fluid into the lumen is configured to perform a function selected from the group consisting of achieve and/or enhance acoustic coupling between the ultrasound array and the target tissue; change the flexibility of the ultrasound device; change the straightness of the ultrasound device; and combinations thereof.

98. The system according to claim 1 and/or any one or more other claims herein, wherein the system is configured to reduce a gripping force applied to the ultrasound device.

99. The system according to claim 98 and/or any one or more other claims herein, wherein the system is configured to reduce the gripping force by: delivering one or more ultrasound pulses; cause one or more portions of the ultrasound device to vibrate; or both.

100. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device is configured to deliver at least 100W/cm2 of energy to treat prostate tissue, tumor tissue, and/or other tissue.

101. The system according to claim 1 and/or any one or more other claims herein, further comprising an introducer device configured to be inserted into the patient and to slidingly receive the ultrasound device.

102. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device is configured to be introduced through a lumen of 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.

103. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device is configured to be inserted through a device configured to be inserted through the bulbar urethra.

104. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises a vibration element configured to reduce insertion force encountered as the ultrasound device is translated through a body conduit of the patient.

105. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises a distal portion comprising a coating.

106. The system according to claim 105 and/or any one or more other claims herein, wherein the coating comprises a PTFE and/or other friction-reducing coating.

107. The system according to claim 1 and/or any one or more other claims herein, wherein the one or more ultrasound transducers comprise one or more CMUT transducers.

108. The system according to claim 1 and/or any one or more other claims herein, wherein the one or more ultrasound transducers comprise one or more piezo transducers.

109. The system according to claim 1 and/or any one or more other claims herein, wherein the one or more ultrasound transducers comprise one or more CMUT transducers and one or more piezo transducers.

110. The system according to claim 1 and/or any one or more other claims herein, wherein the system includes one or more protection diodes configured to prevent damage to the one or more ultrasound transducers.

111. The system according to claim 110 and/or any one or more other claims herein, wherein the one or more protection diodes each have adjustable voltage limits.

112. The system according to claim 110 and/or any one or more other claims herein, wherein the one or more protection diodes are configured to provide high voltage spike protection of the one or more ultrasound transducers.

113. The system according to claim 112 and/or any one or more other claims herein, wherein the one or more protection diodes are configured to provide high voltage spike protection to prevent a cascading breakdown of the one or more ultrasound transducers.

114. The system according to claim 110 and/or any one or more other claims herein, wherein the system comprises a feedback control system that varies the amplitude output and/or phase output of the one or more ultrasound transducers.

115. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound array comprises multiple ultrasound arrays, each including one or more ultrasound transducers.

116. The system according to claim 115 and/or any one or more other claims herein, wherein the multiple ultrasound arrays are constructed and arranged to ablate, stimulate, and/or otherwise treat tissue with a volume of at least lOcc, such as at least 20cc, 40cc, 80cc, 120cc, and/or 150cc.

117. The system according to claim 115 and/or any one or more other claims herein, wherein the ultrasound device is configured to be guided via images provided by the ultrasound device and to deliver ablation, stimulation, and/or other treatment energy to tissue.

118. The system according to claim 117 and/or any one or more other claims herein, wherein the system is configured to deliver ablation energy from the prostatic urethra.

119. The system according to claim 115 and/or any one or more other claims herein, wherein the multiple arrays are configured to independently create images of the patient, and wherein the images created are used to provide: guidance information; diagnostic information; and/or treatment planning information.

120. The system according to claim 115 and/or any one or more other claims herein, further comprising a set of electrical connections and a multiplexer, wherein the multiplexer is configured to selectively connect the electrical connections to each of the multiple ultrasound arrays.

121. The system according to claim 115 and/or any one or more other claims herein, wherein a first ultrasound array is configured to transmit ultrasound and a second ultrasound array is configured to receive the transmitted ultrasound, and wherein the received ultrasound is used to detect and/or measure the relative position between the first ultrasound array and the second ultrasound array.

122. The system according to claim 121 and/or any one or more other claims herein, wherein the first ultrasound array and the second ultrasound array each comprise an array of at least 128 CMUT ultrasound transducers.

123. The system according to claim 121 and/or any one or more other claims herein, wherein the relative position between the first ultrasound array and the second ultrasound array is used to determine delays, wherein the delays are used in creating images using both the first ultrasound array and the second ultrasound array.

124. The system according to claim 121 and/or any one or more other claims herein, wherein the relative position between the first ultrasound array and the second ultrasound array is used to determine delays, wherein the delays are used in delivering ablation, stimulation, and/or other treatment energy to tissue using both the first ultrasound array and the second ultrasound array.

125. The system according to claim 1 and/or any one or more other claims herein, wherein each of the one or more ultrasound transducers of the ultrasound array is configured to switch between an imaging mode and a treatment mode in less than 6 seconds, 100msec, 10msec, and/or 1 millisecond.

126. The system according to claim 125 and/or any one or more other claims herein, wherein the system comprises a switching assembly configured to perform the switching of the ultrasound transducers between the imaging mode and the treatment mode.

127. The system according to claim 126 and/or any one or more other claims herein, wherein the switching assembly comprises switches with a resistance of no more than 3 ohm per channel, a capacitance of no more than 50pF per channel, or both.

128. The system according to claim 126 and/or any one or more other claims herein, wherein the switching assembly comprises imaging drive circuitry, treatment energy drive circuitry, and a set of switches configured to switch between connecting the one or more ultrasound transducers to the imaging drive circuitry and the treatment energy drive circuitry.

129. The system according to claim 128 and/or any one or more other claims herein, wherein the set of switches comprises MEMS switches and/or low-resistance, low-capacitance switches

130. The system according to claim 128 and/or any one or more other claims herein, wherein the imaging drive circuitry comprises a set of receive amplifiers, wherein a receive amplifier is positioned proximal and proximate to each switch of the set of switches.

131. The system according to claim 128 and/or any one or more other claims herein, wherein the switching assembly further comprises a set of bias tees, each bias tee positioned distal to each switch of the set of switches and configured to provide a DC bias to the associated ultrasound transducer.

132. The system according to claim 126 and/or any one or more other claims herein, wherein the switching assembly comprises an adjustable overvoltage protection circuit.

133. The system according to claim 126 and/or any one or more other claims herein, wherein the treatment energy drive circuitry comprises an overshoot protection circuit.

134. The system according to claim 126 and/or any one or more other claims herein, wherein the set of switches comprises a corresponding set of pull-down resistors, each resistor having a resistance of at least 5k0hm and/or at least IMOhm, and configured to dissipate undesired voltage present at each switch.

135. The system according to claim 126 and/or any one or more other claims herein, wherein the switching assembly is configured to operably connect and disconnect each of the ultrasound elements to a bias voltage source.

136. The system according to claim 135 and/or any one or more other claims herein, wherein the switching assembly is configured to test for short-circuits by connecting an ultrasound element to the bias voltage source and measuring the current delivered by the bias voltage source.

137. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound transducers of the ultrasound array are arranged in both a forward-looking and side-looking arrangement.

138. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device further comprises an acoustic lens.

139. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device further comprises a handle.

140. The system according to claim 139 and/or any one or more other claims herein, further comprising a user interface, wherein the handle comprises at least a portion of the user interface.

141. The system according to claim 139 and/or any one or more other claims herein, wherein the handle comprises an alert element comprising a tactile transducer.

142. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device further comprises a cooling module.

143. The system according to claim 142 and/or any one or more other claims herein, wherein the cooling module is mechanically coupled to and/or otherwise positioned proximate to the ultrasound array.

144. The system according to claim 142 and/or any one or more other claims herein, wherein the cooling module is configured to cool the ultrasound array, tissue proximate and/or treated by the ultrasound array, or both.

145. The system according to claim 142 and/or any one or more other claims herein, wherein the cooling module comprises a thermoelectric cooling module.

146. The system according to claim 142 and/or any one or more other claims herein, wherein the cooling module comprises a solid state cooling module.

147. The system according to claim 142 and/or any one or more other claims herein, wherein the cooling module comprises a cooling element and a solid thermal conductor configured to conduct heat away from the cooling element.

148. The system according to claim 142 and/or any one or more other claims herein, wherein the cooling module comprises a fluid pathway that is positioned within the ultrasound device.

149. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises a sensor module including one or more sensors.

150. The system according to claim 149 and/or any one or more other claims herein, wherein the one or more sensors comprise one or more temperature sensors.

151. The system according to claim 149 and/or any one or more other claims herein, wherein the one or more sensors comprise one or more sensors selected from the group consisting of: temperature sensor; pressure sensor; strain gauge; accelerometer; gyroscope, inertial measurement unit, physiologic sensor; GPS sensor; and combinations thereof.

152. The system according to claim 149 and/or any one or more other claims herein, wherein the sensor module is configured to record a parameter of target tissue and/or non-target tissue.

153. The system according to claim 152 and/or any one or more other claims herein, wherein the non-target tissue parameter comprises a parameter selected from the group consisting of: temperature; pressure; and combinations thereof.

154. The system according to claim 149 and/or any one or more other claims herein, wherein the sensor module comprises at least one sensor configured to articulate.

155. The system according to claim 154 and/or any one or more other claims herein, wherein the at least one articulating sensor is configured to rotate and record data while avoiding applying forces to tissue proximate the at least one articulating sensor.

156. The system according to claim 1 and/or any one or more other claims herein, wherein the system comprises a console comprising an ultrasound module for providing drive signals to the ultrasound array.

157. The system according to claim 156 and/or any one or more other claims herein, wherein the ultrasound module comprises a dual-frequency signal generator.

158. The system according to claim 157 and/or any one or more other claims herein, wherein the ultrasound module is configured to produce a drive signal at a first frequency for delivering ultrasound to tissue that is located at a distance of no more than DI from the ultrasound array, and to produce a drive signal at a second frequency for delivering ultrasound to target tissue that is located at a distance of at least D2 from the ultrasound array, wherein D2 is the same or larger than DI, and wherein the first frequency is higher than the second frequency.

159. The system according to claim 158 and/or any one or more other claims herein, wherein the first frequency comprises a frequency of at least 4.5 MHz, wherein the second frequency comprises a frequency of no more than 3.5 MHz, wherein DI comprises a distance of no more than 25mm, and wherein D2 comprises a distance of at least 25mm.

160. The system according to claim 159 and/or any one or more other claims herein, wherein the first frequency comprises a frequency of no more than 5.5 MHz and/or the second frequency comprises a frequency of at least 2.5 MHz.

161. The system according to claim 159 and/or any one or more other claims herein, wherein DI comprises a distance of at least 0.001mm and/or wherein D2 comprises a distance of no more than 50mm.

162. The system according to claim 156 and/or any one or more other claims herein, wherein the ultrasound module comprises a tuned circuit that operates at one or more frequencies of at least 1 MHz, and/or at one or more frequencies of no more than 10 MHz.

163. The system according to claim 156 and/or any one or more other claims herein, wherein the ultrasound module comprises two electronically switchable tuned circuits configured to provide operation at multiple different frequencies.

164. The system according to claim 163 and/or any one or more other claims herein, wherein the ultrasound module comprises relays and/or other switching components configured to switch between components of the two electronically switchable tuned circuits.

165. The system according to claim 163 and/or any one or more other claims herein, wherein one or more components of a first tuned circuit of the two electronically switchable tuned circuits is shared by a second tuned circuit of the two electronically switchable tuned circuits.

166. The system according to claim 163 and/or any one or more other claims herein, wherein the ultrasound module is configured to operate a first set of one or more transducers of the ultrasound array at a first frequency and to simultaneously operate a second set of one or more transducers of the ultrasound array at a second frequency that is different than the first frequency.

167. The system according to claim 1 and/or any one or more other claims herein, wherein the ultrasound device comprises an identifying component, and wherein the console is configured to receive information from the identifying component.

168. The system according to claim 167 and/or any one or more other claims herein, wherein the identifying component comprises an RFID.

169. The system according to claim 167 and/or any one or more other claims herein, wherein the information received from the identifying component comprises diagnostic information, calibration information, and/or manufacturing information of the ultrasound device.

170. The system according to claim 167 and/or any one or more other claims herein, wherein the information received from the identifying component is used by the console to confirm the ultrasound device is properly indicated, properly configured, and/or otherwise ready for use.

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

172. The system according to claim 171 and/or any one or more other claims herein, wherein the ultrasound device comprises a cooling module that is constructed and arranged to receive cooling fluid provided by the cooling device.

173. The system according to claim 172 and/or any one or more other claims herein, wherein the cooling module comprises one or more fluid pathways that are positioned within the ultrasound device, wherein the one or more fluid pathways receive the cooling fluid provided by the cooling device.

174. The system according to claim 1 and/or any one or more other claims herein, further comprising a processing unit comprising a processor and a memory storage element coupled to the processor, wherein the memory storage component stores instructions for the processor to perform an algorithm.

175. The system according to claim 174 and/or any one or more other claims herein, further comprising a console, wherein the console comprises at least a portion of the processing unit.

176. The system according to claim 174 and/or any one or more other claims herein, wherein the ultrasound device comprises at least a portion of the processing unit.

177. The system according to claim 174 and/or any one or more other claims herein, wherein the algorithm comprises an artificial intelligence algorithm.

178. The system according to claim 174 and/or any one or more other claims herein, wherein the system is configured to produce a multi-dimensional image of tissue, and wherein the algorithm comprises an artificial intelligence algorithm or other algorithm that is configured to: identify tissue areas to avoid treating; and/or suggest tissue areas to be treated.

179. The system according to claim 174 and/or any one or more other claims herein, wherein the algorithm comprises an artificial intelligence algorithm or other algorithm that is configured to assess image data to maintain a focal spot for delivery of ablation, stimulation, and/or other treatment energy.

180. The system according to claim 179 and/or any one or more other claims herein, wherein the algorithm is configured to modify delays of signals delivered to the ultrasound transducers to maintain the focal spot.

181. The system according to claim 174 and/or any one or more other claims herein, wherein the algorithm comprises 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.

182. The system according to claim 174 and/or any one or more other claims herein, wherein the processing unit further comprises at least one application configured to be provided and/or performed by the system.

183. The system according to claim 1 and/or any one or more other claims herein, wherein the system comprises a user interface.

184. The system according to claim 183 and/or any one or more other claims herein, further comprising a console, wherein the console comprises at least a portion of the user interface.

185. The system according to claim 183 and/or any one or more other claims herein, wherein the ultrasound device comprises at least a portion of the user interface.

186. The system according to claim 183 and/or any one or more other claims herein, wherein the user interface comprises an alert element.

187. The system according to claim 186 and/or any one or more other claims herein, wherein the alert element comprises a tactile transducer positioned in the ultrasound device.

188. The system according to claim 183 and/or any one or more other claims herein, wherein the user interface comprises a touchscreen display and/or other display.

189. The system according to claim 183 and/or any one or more other claims herein, wherein the user interface is configured as a graphical user interface.

190. The system according to claim 1 and/or any one or more other claims herein, further comprises one or more functional elements.

191. The system according to claim 190 and/or any one or more other claims herein, wherein the one or more functional elements comprise one or more sensors and/or one or more transducers.

192. The system according to claim 190 and/or any one or more other claims herein, wherein the functional element comprises one or more vacuum ports positioned proximate the ultrasound array.

193. The system according to claim 192 and/or any one or more other claims herein, wherein the one or more vacuum ports are configured to: prevent motion of the ultrasound array; maintain a portion of the ultrasound device in contact with tissue; or both.

194. The system according to claim 1 and/or any one or more other claims herein, further comprising a robotic manipulator configured to robotically manipulate the ultrasound device and/or one or more other components of the system.

195. The system according to claim 194 and/or any one or more other claims herein, wherein the robotic manipulator is configured to rotate the ultrasound device to create a 360° image of tissue and/or at least an image of tissue of more than 180°.

196. The system according to claim 1 and/or any one or more other claims herein, further comprising an agent comprising one or more agents.

197. The system according to claim 1 and/or any one or more other claims herein, further comprising a network and at least one server.

198. The system according to claim 1 and/or any one or more other claims herein, further comprising a second medical device.

199. The system according to claim 1 and/or any one or more other claims herein, further comprising a second imaging device comprising at least one imaging device.

200. The system according to claim 199 and/or any one or more other claims herein, wherein the second imaging device comprises 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 thereof.

201. The system according to claim 199 and/or any one or more other claims herein, wherein the system is configured to produce a first set of one or more images using the ultrasound device and to produce a second set of one or more images using the second imaging device, and wherein the system is further configured to compare and/or combine the first set of images with the second set of images.

202. The system according to claim 1 and/or any one or more other claims herein, further comprising an accessory device comprising at least one accessory device.

203. The system according to claim 202 and/or any one or more other claims herein, wherein the accessory device comprises a positioning device configured to establish one or more reference points used by the ultrasound device for creating images, delivering treatment energy, or both.

04. The system according to claim 202 and/or any one or more other claims herein, wherein the accessory device comprises a balloon catheter, wherein the balloon catheter is configured to dilate the urethral passage.