System and method for intrauterine imaging and treatment

Abstract

Disclosed herein is a computing system for performing a tumor ablation procedure comprising a processor configured to obtain image data, monitor changes in tissue morphology during treatment with ultrasound-based imaging techniques to determine whether tissue has been treated, and to generate user interface data for rendering a user interface comprising an ultrasound image corresponding to the image data and comprising indicia of whether the tissue has been treated. The processor may also determine a position of a serosa from the image data, and the user interface may comprise a serosa tracker superimposed on an ultrasound image, the serosa tracker corresponding to the position of the serosa. The ultrasound image may include a serosa representation, a portion of which obscured by a shadow effect caused by a portion of an imaging device in the ultrasound image, can be constructed by the processor.

Description

Attomey Docket No. :SUR.0129 WO SYSTEM AND METHOD FOR INTRAUTERINE IMAGING AND TREATMENT TECHNICAL FIELD

[0001] The present disclosure relates to tissue imaging and ablation systems and methods, particularly for use in the treatment of uterine fibroids.BACKGROUND

[0002] Uterine fibroids are benign tumors of the uterine myometria (i.e.. muscle) and are the most common tumor of the female pelvis. Fibroid tumors affect up to 30% of women of childbearing age and can cause significant symptoms such as discomfort, pelvic pain, menorrhagia, pressure, anemia, compression, infertility and miscarriage. Fibroids may be located in the myometrium (i.e., intramural), adjacent to the endometrium (i.e., submucosal), or adjacent to the outer layer of the uterus (i.e., subserosal). Most commonly fibroids are a smooth muscle overgrowth that arise intramurally and can grow' to be several centimeters in diameter.

[0003] Uterine fibroids can be reduced and / or eliminated by ablation, for example, with electrical energy (e.g., RF energy). Electrical energy (e.g., RF energy) can be delivered to uterine fibroids from an electrical power source (e.g., an RF generator) in electrical communication wdth an active electrode, such as a needle or an array of needles. The active electrode (e.g., a needle or array of needles) may be delivered transvaginally or transcervically. positioning it in proximity to a fibroid by passing through the vagina, through the cervix, and into / around the uterine cavity. Alternatively, the active electrode can be delivered laparoscopically into proximity to a fibroid. The power source can be configured to deliver monopolar or bipolar electrical energy', as described above. To facilitate locating the fibroids and positioning the active electrode within the fibroids, the device includes an ultrasound transducer, which may be connected to an imaging console for display of the environment within the field of view' of the ultrasound transducer. The ultrasound transducer may be articulatable to adjust the field of view' in a generally forward or lateral direction relative to an axial shaft carry ing the active electrode. The active electrode may be deployed or distally advanced from the shaft and across the field of view, so that the active electrode can be visualized and directed into the tissue and the targeted fibroid.

[0004] Various devices and systems for imaging and / or treating uterine fibroids or other tissue are described in commonly owned U.S. Pat. Nos. 8,088,072 and 8,262,577, as wellAttorney Docket No. :SUR.0129 WO as U.S. Pat Nos. 7,815,571, 7,874,986, 7,918,795, 8,506,485, 8,992,427, 9,357,977, 9,517,047, 9,861,336, 10,993,770, and 11,219,483; U.S. Publication Nos. 2019 / 0350648 and 2023 / 0260121, and PCT Publication Nos. WO 2024 / 006708 and WO 2024 / 006789, the entireties of each of which are hereby incorporated by reference.

[0005] Current systems, devices, and methods for therapeutic or diagnostic procedures, such as for treatment for uterine fibroids, may be less than ideal in at least some respects. For example, it is ty pically desirable to simultaneously operate the active electrode and the ultrasound transducer in order to visualize the ablation procedure of the uterine fibroids. However, due to the close proximity of the transmission line used to deliver electrical energy to the active electrode and the transducer lines used to convey ultrasound energy to and from the ultrasound imaging array, noise and crosstalk (i.e., electrical and acoustic) may be induced between the transmission line and transducer lines, which can degrade the quality of the resulting ultrasound images. Furthermore, if firm contact is not made between the ultrasound transducer and the tissue to be imaged, air pockets may form between the ultrasound imaging array and the tissue, resulting in a degradation in the quality of the resulting ultrasound images. Also, although known systems may communicate data from sensors located on the device to the imaging console (e.g., data providing the linear position of a deployed electrode relative to the shaft of the device), the processing of such data increases the computational burden of the imaging console, which must already process the imaging signals generated by the ultrasound imaging device to generate the ultrasound images. Furthermore, interference from other sources in proximity to the device, e.g., electrical noise from the electrical transmission lines, may significantly decrease the signal-to-noise ratio of the sensor signals prior to amplification and processing within the imaging console. Also, if new devices are introduced or if devices are upgraded with new sensor electronics, expensive software upgrades must be made in order to make the imaging console compatible with the new sensor electronics.

[0006] Additionally, interpreting raw ultrasound images may be difficult, such as interpreting the images to determine which tissue regions have been treated (e.g., by ablation), which tissue regions are healthy, which are fibroids, or which are other ty pes of tumors. Furthermore, the active electrode on the device used to image and treat tissue, when deployed, may partially block the view of the ultrasound transducer, causing a "shadow effect”; that is, the view- of the ultrasound transducer is blocked by7the deployed active electrode, creating a “shadow ” in the ultrasound image, and possibly obscuring the view ofAttomey Docket No. :SUR.0129 WO important anatomical features in the ultrasound image, including the serosa (the outer layer of tissue that covers the uterus), endometrial lining, and / or fibroid edges. Furthermore, it is difficult to determine the progress of a tissue ablation simply by looking at an ultrasound image.SUMMARY

[0007] In accordance with a first aspect of the present inventions, a computing system for performing a tumor ablation procedure is provided. The computing system comprises one or more processors configured to obtain image data originating from an imaging device useable to generate ultrasound images, monitor changes in tissue morphology during treatment with one or more ultrasound-based imaging techniques (e.g., elastography, acoustic thermometry', and / or speckle tracking) to determine whether tissue (e.g., uterine fibroids) has been treated, the tissue morphology comprising at least tissue stiffness, and generate user interface data for rendering a user interface comprising an ultrasound image corresponding to the image data, the user interface comprising indicia of whether the tissue has been treated based on changes in the tissue morphology' (e.g., using color variations corresponding to the changes in the tissue morphology).

[0008] In one embodiment, the processor(s) are configured to identify healthy tissue and tumorous tissue from the tissue morphology7, and generate the user interface data to render the user interface w ith indicia of the healthy tissue and the tumorous tissue. In other embodiments, the processor(s) are configured to determine how long the tissue has been treated from the changes in the tissue morphology, determine whether treatment is complete from the changes in the tissue morphology, and / or indicate via the user interface whether to continue treatment or terminate treatment. In still another embodiment, the imaging device is useable to deliver RF energy to ablate intrauterine fibroids.

[0009] In accordance with a second aspect of the present inventions, a system for imaging uterine tissue is provided. The system comprises an imaging device comprising an elongate probe, an ultrasound transducer disposed on a distal end of the elongate probe for generating image data of the uterine tissue. The system further comprises an image generator comprising the computing system connected to the imaging device.

[0010] In accordance with a third aspect of the present inventions another computing system for imaging a uterus for fibroid treatment is provided. The system comprises one or more processors configured to obtain imaging data originating from an imaging deviceAttorney Docket No. :SUR.0129 WO within a uterine cavity of a patient, determine a position of a serosa from the image data, and generate user interface data for rendering a user interface comprising a serosa tracker superimposed on an ultrasound image. The serosa tracker corresponds to the position of the serosa.

[0011] In one embodiment, the image data originates from the imaging device during a calibration transducer scan before deploying an active electrode for ablation. In this case, the processor(s) may be configured to display the serosa tracker when a portion of the serosa is occluded from view within the ultrasound image due to a shadow effect after deploying the active electrode. In this embodiment, the processor(s) are configured to determine the position of the serosa with a machine learning model trained to identify serosas with a preexisting image dataset. In this embodiment, the image data may correspond to a plurality of poses in which the imaging device is oriented during the calibration transducer scan. Such poses may include, e.g.. a first angular position of the imaging device and a second angular position of the imaging device, with the first angular position being orthogonal to the second angular position about an axis. In this embodiment, the processor(s) may be configured to determine boundaries including a treatment boundary’ and a safety boundary based on user input via the imaging device, update the user interface with indicia of the boundaries, obtain a plurality of safety rotation images comprising a plurality of planes of view during a safety' rotation transducer scan after the active electrode is deployed, and automatically determine whether the boundaries are safely positioned relative to the serosa tracker in the plurality of planes of view from the plurality of safety rotation images. The processor(s) may be configured to enhance a portion of the serosa obscured by a shadow effect in the ultrasound image based on constructing the portion of the serosa from a plurality' of images obtained at different poses during the safety rotation transducer scan. The processor(s) may also be configured to construct the portion of the serosa with a 3D imaging technique.

[0012] In accordance with a fourth aspect of the present inventions, another system for imaging uterine tissue is provided. The system comprises an imaging device comprising an elongate probe, an ultrasound transducer disposed on a distal end of the elongate probe for generating image data of the uterine tissue, and an active electrode deployable from the elongate probe. The system further comprises an image generator comprising the computing system connected to the imaging device.Attorney Docket No. :SUR.0129 WO

[0013] In accordance with a fifth aspect of the present inventions, still another computing system for imaging a uterus for fibroid treatment is provided. The system comprises one or more processors configured to obtain imaging data originating from an imaging device within a uterine cavity of a patient, generating user interface data for rendering a user interface with an ultrasound image from the image data, wherein the ultrasound image includes a serosa representation, and constructing a portion of the serosa representation obscured by a shadow effect caused by a portion of the imaging device in the ultrasound image.

[0014] In one embodiment, the image data originates from the imaging device within the uterine cavity of the patient during a safety rotation transducer scan wherein the image data corresponds to a plurality7of poses in which the imaging device is oriented during the safety rotation transducer scan. In this case, the portion of the serosa representation obscured by the shadow effect in the ultrasound image is constructed from the image data obtained at the plurality of poses during the safety rotation transducer scan, e.g., using a 3D imaging technique. In another embodiment, the processor(s) may be configured to obtain the image data from the imaging device within the uterine cavity of the patient while an active electrode is deployed from the imaging device. The portion of the imaging device that causes the shadow effect in the ultrasound image comprises the deployed active electrode.

[0015] In accordance with a sixth aspect of the present inventions, a system for imaging uterine tissue is provided. The system comprises an imaging device comprising an elongate probe, an ultrasound transducer disposed on a distal end of the elongate probe for generating image data of the uterine tissue, and an active electrode (e.g. an introducer) deployable from the elongate probe. The system further comprises an image generator comprising the computing sy stem connected to the imaging device.

[0016] In accordance with a seventh aspect of the present inventions, an imaging and treatment device is provided. The imaging and treatment device comprises an elongate probe, a transducer (e.g., an ultrasound transducer) carried by the elongate probe configured to image tissue (e.g. uterine tissue), and an introducer configured to extend from the elongate probe along a longitudinal introducer axis adjacent to the transducer into the tissue. The longitudinal introducer axis is offset from a transducer plane extending longitudinally along a midline of the transducer. In one embodiment, the longitudinal introducer axis intersects the transducer plane at an angle (e.g., between 1°Attorney Docket No. :SUR.0129 WO and 10°). In another embodiment, the longitudinal introducer axis is parallel with the transducer plane. The longitudinal introducer axis is separated from the transducer plane by a distance (e.g., between 0.5mm and 2mm).

[0017] In accordance with an eighth aspect of the present inventions, another imaging and treatment device is provided. The imaging and treatment device comprises an elongate probe, a transducer carried by the elongate probe configured to image tissue, and an introducer deployable from the elongate probe along a longitudinal introducer axis adjacent to the transducer into the tissue, such that introducer causes a shadow effect in the image of the tissue. The introducer has a tip, a body, and a waist positioned between the tip and the body. The waist has a smaller cross-sectional area than the tip and the body, such that the shadow effect in the image of the tissue is reduced. In one embodiment, the introducer is hollow, thereby reducing the shadow effect in the image of the tissue. In another embodiment, the introducer is meshed, thereby reducing the shadow effect in the image of the tissue.

[0018] In accordance with a ninth aspect of the present inventions, yet another a computing system for imaging a uterus is provided. The system comprises one or more processors configured to obtain image data originating from a transducer of an imaging device, wherein the image data is useable to generate an ultrasound image, dynamically update one or more image settings while the transducer is generating the image data based on a depth at which an introducer is deployed to enhance a visual contrast between one or more features of interest (e.g., a serosa, a fibroid, or an endometrial lining) and adjacent tissue in the ultrasound image, and generate user interface data for rendering a user interface comprising the ultrasound image corresponding to the image data with the one or more image settings. In one embodiment, dynamically updating the image setting(s) includes updating one or more of a focal point, a gain, a filter, apodization, or a transmission pressure. In another embodiment, the processor(s) are configured to dynamically update one or more image settings repeatedly during an ablation procedure.

[0019] In accordance with a tenth aspect of the present inventions, yet another computing system for performing a tissue ablation procedure is provided. The computing system comprises one or more processors configured to access electrical signals originating from an acoustic sensor responsive to detecting acoustic cavitation at a treatment site, determine an ablation location from the electrical signals, determine an ablation rate from the electrical signals, and modulate an energy output from an energy source to an ablationAttomey Docket No. :SUR.0129 WO device (e g., by modulating a power output or modulating a duration of energy output) to modify the ablation rate.

[0020] The embodiments disclosed herein each have several aspects no single one of which is solely responsible for the disclosure's desirable attributes. Without limiting the scope of this disclosure, its more prominent features will now be briefly discussed. After considering this discussion, and particularly after reading the section entitled “Detailed Description,” one will understand how the features of the embodiments described herein provide advantages over existing systems, devices and methods. Various combinations of the above and below recited features, embodiments, implementations, and aspects are also disclosed and contemplated by the present disclosure. Additional implementations of the disclosure are described below in reference to the appended claims, which may serve as an additional summary of the disclosure. In various implementations, systems and / or computer systems are disclosed that comprise a computer-readable storage medium having program instructions embodied therewith, and one or more processors configured to execute the program instructions to cause the systems and / or computer systems to perform operations comprising one or more aspects of the above- and / or below-described implementations (including one or more aspects of the appended claims). In various implementations, computer-implemented methods are disclosed in which, by one or more processors executing program instructions, one or more aspects of the above- and / or below-described implementations (including one or more aspects of the appended claims) are implemented and / or performed. In various implementations, computer program products comprising a computer-readable storage medium are disclosed, wherein the computer-readable storage medium has program instructions embodied therewith, the program instructions executable by one or more processors to cause the one or more processors to perform operations comprising one or more aspects of the above- and / or below-described implementations (including one or more aspects of the appended claims).BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Various implementations will be described hereinafter with reference to the accompanying drawings. These implementations are illustrated and described by example only, and are not intended to limit the scope of the disclosure. In the drawings, similar elements may have similar reference numerals.Attorney Docket No. :SUR.0129 WO

[0022] FIG. 1 A shows an imaging and treatment system for imaging and / or treating uterine fibroids.

[0023] FIG. IB shows another example implementation of an imaging and treatment system.

[0024] FIG. 2A shows an example implementation of a cable that is connectible with an imaging and treatment device.

[0025] FIG. 2B is a cutaway side view of a handle connector of a cable.

[0026] FIG. 2C is a cutaway bottom view of an ultrasound generator connector.

[0027] FIG. 2D is a schematic diagram of an imaging and treatment device with a cable.

[0028] FIG. 3A is a top perspective of an imaging and treatment device.

[0029] FIG. 3B is a bottom perspective view of the proximal end of the imaging and treatment device.

[0030] FIG. 3C is an exploded side view of the imaging and treatment device.

[0031] FIGS. 3D-3E are exploded top view of the imaging and treatment device.

[0032] FIG. 3F is a top perspective of an alternative imaging and treatment device.

[0033] FIG. 4 is a cutaway side view of the imaging and treatment device.

[0034] FIG. 5A is a cutaway side view of a transducer and elongate probe of the imaging and treatment device.

[0035] FIGS. 5B-5D illustrate various articulation angles of the transducer.

[0036] FIG. 6A illustrates an imaging and treatment component inside a uterus.

[0037] FIG. 6B shows an image that can be visible on a display during imaging and treatment.

[0038] FIGS. 6C-6D show the imaging and treatment device as present in the patient in combination with the image present on the display during a treatment procedure.

[0039] FIG. 7 illustrates an example user interface providing a visualization of the orientation of the imaging and treatment device.

[0040] FIGS. 8A-8B show an imaging and treatment device within a uterus with fibroids.

[0041] FIGS. 9A-9B illustrate an example user interface showing fibroid treatment within a uterus.

[0042] FIG. 10 shows a user interface displaying an ultrasound image of a uterus showing the serosa.

[0043] FIG. 11 A shows an example serosa tracker superimposed on the ultrasound image over the serosa.Attorney Docket No. :SUR.0129 WO

[0044] FIG. 1 IB shows an example ultrasound image with the serosa partially obstructed from view by a shadow effect.

[0045] FIG. 11C shows an example serosa tracker superimposed over a partially shadowed serosa.

[0046] FIG. 11D shows a user interface with treatment boundary safety boundary superimposed on the ultrasound image and safely positioned relative to the serosa tracker.

[0047] FIG. HE shows a user interface with treatment boundary safety boundary superimposed on the ultrasound image and dangerously positioned relative to the serosa tracker.

[0048] FIG. 12 shows an example imaging and treatment device configured to reduce the shadow effect in images obtained with the device.

[0049] FIG. 13 shows an example imaging and treatment device configured to reduce the shadow effect in images obtained with the device.

[0050] FIG. 14 shows an example introducer that has a tip, a waist, and a body.DETAILED DESCRIPTION

[0051] The present disclosure will now be described with reference to the accompanying figures, wherein like numerals may refer to like elements throughout. The following description is merely illustrative in nature and is in no way intended to limit the disclosure, its application, or uses. It should be understood that steps within a method may be executed in different order without altering the principles of the present disclosure. Furthermore, the devices, systems, and / or methods disclosed herein can include several novel features, no single one of which is solely responsible for its desirable attributes or which is essential to practicing the devices, systems, and / or methods disclosed herein. Additionally, the structures, systems, and / or devices described herein may be embodied as integrated components or as separate components.

[0052] Unless expressly stated otherwise, all principles and embodiments disclosed herein are not limited to ablation of only one specific type of tissue or to tissue in and / or around only one organ or region of the body. Instead, the skilled artisan will appreciate that the principles and embodiments disclosed herein can be applied to the ablation of different types of tissues in various regions of the body including but not limited to tissues in and / or around the heart, lungs, breast, thyroid, liver, kidneys, bones, adrenal glands, endometrium and / or uterus. One of skill in the art will recognize that the imaging components asAttorney Docket No. :SUR.0129 WO described herein may be used with similar instruments, including non-ablative instruments, in other therapeutic or diagnostic applications for example: instruments for tissue biopsy, for drug delivery', for fluid infusion and / or aspiration, and for the treatment of cancers, tumors, fibroids, and other masses, malignant or benign, in any suitable bodily lumen. Nonetheless, for purposes of explanation and clarity', a nonlimiting example of uterine fibroid ablation is illustrated and discussed herein. While the disclosed systems and methods suitable for non-invasive surgery', the systems and methods may also be suitable for minimally invasive surgery or laparoscopic procedures. In certain embodiments, the systems and methods may be suitable for robotic or robot assisted surgical procedures.

[0053] FIG. 1A shows an imaging and treatment system 100 (which may also be referred to as system 100) for imaging and / or treating uterine fibroids. The system 100 includes an energy source 105. an imaging and treatment device 101, a cable 103, and an ultrasound generator 107. The imaging and treatment device 101 (may also be referred to as an imaging device, treatment device, and / or ablation device) is removably connectible with the cable 103. The cable 103 is removably connectible with the energy' source 105 and the ultrasound generator 107. The energy source 105 can be an electrical power generator configured to generate radiofrequency (RF) energy. The cable 103 may be a reusable cable. The imaging and treatment device 101 may be a disposable (e.g., single-use) device. The ultrasound generator 107 includes a display 109 for displaying ultrasound images (e.g., sonograms). In some implementations, the display 109 is separate from the ultrasound generator 107. In other implementations, the ultrasound generator 107 and energy’ source 105 form a single, integrated unit as part of the same device.

[0054] As shown, the imaging and treatment device 100 can be at least partially inserted trans cervically into the uterus 104 of a patient 102. The imaging and treatment device 100 can receive energy from the energy source 105 via the cable 103 and can provide the energy to a fibroid in the uterus 104 via an electrode to ablate the fibroid.

[0055] In this example, the imaging and treatment system 100 has a monopolar configuration. Dispersive electrodes 106 (which may also be referred to as grounding electrodes, neutral electrodes, or return electrodes) are connected to the patient 102. The dispersive electrodes 106 are electrically coupled with the energy source 105. Energy from the energy source 105 is delivered in a circuit: from the energy source 105 to the imaging and treatment device 101, through the target tissue in the uterus 104 to the dispersive electrodes 106, then back to the energy' source 105. In some implementations, the imagingAttomey Docket No. :SUR.0129 WO and treatment system 100 comprises one dispersive electrode or two or more dispersive electrodes.

[0056] FIG. IB shows another example implementation of the imaging and treatment system 100. The imaging and treatment device 101 includes an imaging transducer 121, an elongate probe 119, and a handle 117. The cable includes an interconnect cable 103, an ultrasound cable 111, and an energy cable 113.

[0057] The ultrasound cable 111 can conduct electrical signals comprising information between the imaging and treatment device 101 and the ultrasound generator 107. Such information can include sensor data (e.g., inertial sensor data, hall-effect sensor data), orientations of the imaging and treatment device 101, introducer position, electrode tine position, articulation angle of the transducer 121, and / or transducer data useable to generate an ultrasound image (e.g., a sonogram). As another example, the energy cable 113 can conduct energy from the energy source 105 to the imaging and treatment device 101.

[0058] The energy cable 113 can conduct energy, such as RF energy, from the energy source 105 to the imaging and treatment device 101.

[0059] The ultrasound generator 107 can include one or more hardware processors 123. The hardware processor 123 can process information from the imaging and treatment device 101, such as device 101 orientation, introducer position, electrode tine position, articulation angle of the transducer 121, and / or transducer image data. The hardware processor 123 can generate user interface data useable to render a user interface via the display 109, which can include an ultrasound image. The energy’ source 105 can include one or more hardware processors 125.

[0060] In some implementations, one or more of the display 109, the ultrasound generator 107, or the energy’ source 105 are embodied with the same device 115, such as within a common structure or housing. In some implementations, the display 109 and ultrasound generator 107 form a single, integrated unit. In some implementations, the display 109 is remote to the ultrasound generator 107 as a separate device.

[0061] FIG. 2 A shows an example cable 200 comprising a handle connector 201, an energy source connector 203, an ultrasound generator connector 205, an interconnect cable 207, an energy’ source cable 209, and an ultrasound cable 211. The cable 200 can be reusable.

[0062] The handle connector 201 can removably connect with a handle of an imaging and treatment device (for example, with handle 117 of imaging and treatment device 101 shown and / or described in FIG. IB). The electrical connector 202 can electrically couple withAttorney Docket No. :SUR.0129 WO electronics in the handle and can exchange electrical information with electronics in the handle. The ultrasound generator connector 205 can removably connect with an ultrasound generator. The energy' source connector 203 can removably connect with an energy source for example as shown and / or described in FIGS. 1A-1B. The energy source connector 203 can include one or more electrical pins configured to electrically connect with the energy source. The energy' source connector 203 can receive energy (e.g., RF energy) from the energy source and can provide the energy' to the energy source cable 209 to be provided to the handle of an imaging and treatment device via the handle connector 201.

[0063] The handle connector 201 is connected with the interconnect cable 207 which in turn is connected with the energy source cable 209 and the ultrasound cable 211. Each of the various cable portions (e.g., the interconnect cable 207, the energy source cable 209, and the ultrasound cable 211) can include electrically conductive material that can conduct energy and / or electrical signals such as shown and / or described in FIG. IB. The interconnect cable 207 and the ultrasound cable 211 can conduct electrical signals comprising information between the handle connector 201 and the ultrasound generator connector 205. Such information can include sensor data (e.g., inertial sensor data, halleffect sensor data), device orientation, introducer position, electrode tine position, transducer articulation angle, and / or transducer data useable to generate an ultrasound image (e.g., a sonogram). As another example, the energy source cable 209 can conduct RF energy from the energy' source connector 203 to the interconnect cable 207 which can in turn conduct the RF energy to the electrical connector 202. In some implementations, the interconnect cable 207 and / or the energy source cable 209 can conduct electrical signal comprising information relating to the operation of the imaging and treatment device from the electrical connector 202 to the energy source connector 203 to provide operational feedback to the energy source and / to control an operation of the energy source.

[0064] The cable 200 can be reused for a plurality of different procedures, including with different patients and / or with different imaging and treatment device handles. For example, the cable 200 can be connected and operated with a first handle during a procedure on a first patient and then disconnected from the first handle and connected with a second handle during a procedure with a second patient. Between procedures, the cable 200 can be sterilized in an autoclave.

[0065] FIG. 2B is a cutaway side view of the handle connector 201 shown and / or described in FIG. 2 A. The handle connector 201 includes an interconnect printed circuit board (PCB)Attomey Docket No. :SUR.0129 WO 215 positioned within the interior of the handle connector 201. The interconnect PCB 215 is electrically coupled with the electrical connector 202 such that the interconnect PCB 215 can exchange electrical signals with the electrical connector 202. At least one hardware processor 214 and inertial sensor 213 are positioned on, and electrically coupled with, the interconnect PCB 215. A power converter can be coupled with the interconnect PCB 215 and can convert power from the energy source. The power converter can be a DC to DC converter and can, for example, convert 5V to 3.3V. The power converter can be an integrated circuit.

[0066] The inertial sensor 213 can generate sensor data (e.g., inertial data) responsive to movement. The inertial sensor 213 can include one or more of an accelerometer, a gyroscope, or an inclinometer (also referred to as a tilt sensor). Data generated by inertial sensor 213 can be useable to determine orientation of the handle connector 201. Moreover, when the handle connector 201 is connected with an imaging and treatment device handle, data from the inertial sensor 213 can indicate the orientation of the handle (and also an elongate probe and transducer connected with the handle) at least because the handle connector 201 may be rigidly connected with the handle.

[0067] The hardware processor 214 can comprise one or more integrated circuits. The hardware processor 214 can comprise and / or have access to memory. The hardware processor 214 can comprise and / or be embodied as one or more chips, controllers such as microcontrollers (MCUs), and / or microprocessors (MPUs). The hardware processor 214 can comprise a central processing unit (CPU). In some implementations, the hardware processor 214 can be embodied as a system-on-a-chip (SoC). The hardware processor 214 can allow multiple processes to execute simultaneously. The hardware processor 214 can be configured to execute program instructions to cause the cable 200 and / or intrauterine system to perform one or more operations. The hardware processor 214 can be configured, among other things, to process data, execute instructions to perform one or more functions, and / or control the operation of the intrauterine system or components thereof. For example, the hardware processor 214 can process sensor data obtained from sensors in a device handle and / or sensor data originating from the inertial sensor 213, and can execute instructions to perform functions related to storing and / or transmitting such data.

[0068] Any of the electronic components of the handle connector 201, such as the electrical connector 202, inertial sensor 213, hardware processor 214, and / or the interconnect PCB 215, can have temperature ratings sufficient to withstand a sterilization process in anAttorney Docket No. :SUR.0129 WO autoclave. Moreover, any of said components can be coated with a protective coating to inhibit degradation of the components during sterilization in an autoclave.

[0069] FIG. 2C is a cutaway bottom view of the ultrasound generator connector 205 shown and / or described in FIG. 2A. The ultrasound generator connector 205 includes a PCB 217 positioned with the interior of the ultrasound generator connector 205. At least one hardware processor 219 is positioned on, and electrically coupled with, the PCB 217. The hardware processor 219 can include similar structural and / or operational features as the interconnect PCB 215 shown and / or described herein. For example, the hardware processor 219 can comprise and / or be embodied as one or more integrated circuits, one or more chips, controllers (e.g., MCUs), and / or microprocessors (MPUs), CPUs, and / or SoCs. The hardware processor 219 can comprise and / or have access to memory'.

[0070] The hardware processor 219 can be in electrical communication with one or more electronics components in the handle connector 201, such as the inertial sensor 213 and / or the hardware processor 214. The hardware processor 219 can receive inertial data originating from the inertial sensor 213. In some implementations, the hardware processor 219 can process data from inertial sensor 213 such as to determine an orientation of the imaging and treatment device. The hardware processor 219 can be in electrical communication with one or more electronic components in an imaging and treatment device handle such as sensors used to measure introducer and / or electrode tine position. For example, the hardware processor 219 can receive sensor data, via the handle connector 201, that originates from sensors (e.g.. articulation sensor 325 and / or carriage sensors 318 shown, for example, in FIG. 3D) shown and / or described herein and can determine introducer position, electrode tine position, and / or transducer articulation angle from said sensor data. The hardware processor 219 can receive sensor data after it has been converted to digital data by an analog to digital converter. In some implementations, such as when calibrating an imaging and treatment device, the hardware processor 219 can communicate data, via the handle connector 201, to the imaging and treatment device. Such data can include position information that has been calibrated with sensor data (e.g., voltage data). Such data can be stored in memory' in the imaging and treatment device handle (e.g., on an EPROM). For example, the hardware processor 219 can receive sensor data (which may have been converted to digital by an ADC) during a calibration protocol and can correlate voltages of the sensor data with know n positions of the introducer, electrode tines, and / or transducer to generate calibration data. Known positions can be generated from separateAttorney Docket No. :SUR.0129 WO sensors connected to mechanical sliders. The hardware processor 219 can communicate the calibration to the storage component (e.g., EEPROM) in the imaging and treatment device to program the storage component with the calibration data. During imaging / treatment operation, the hardware processor 219 can receive sensor data (e.g., from an ADC) and can determine positions, as described, based on accessing calibration data in the storage component to determine positions associated with the received sensor data. In some implementations, the hardware processor 219 can receive positions directly from the imaging and treatment device 301 (e.g., from hardware processors 368) which itself accesses the calibration data in the EEPROM and the sensor data to determine the positions and then communicates the positions to the hardware processor 219. In some implementations, hardware processor 214 in the handle connector 201 and / or hardware processor 368 in the imaging and treatment device 301 can receive, process, and communicate, data in a similar manner as described with hardware processor 219. In some implementations, hardware processor 123 in the ultrasound generator 107 (or other separate computing device) can receive, process, and communicate, data in a similar manner as described with hardware processor 219.

[0071] Any of the electronic components of the ultrasound generator connector 205. such as the PCB 217 and / or the hardware processor 219, can have temperature ratings sufficient to withstand a sterilization process in an autoclave. Moreover, any of said components can be coated with a protective coating to inhibit degradation of the components during sterilization in an autoclave.

[0072] FIG. 2D is a schematic diagram of an imaging and treatment device 220 with a cable 230. The cable 230 can be reusable. The imaging and treatment device 220 can include similar structural and / or operational features as any of the other example imaging and treatment devices shown and / or described herein. For example, the imaging and treatment device 220 can include a transducer 221. elongate probe 223, acoustic flex 225, and handle PCB 227. The cable 230 can conduct energy from the energy source 235, via the energy transmission lines 234, for fibroid ablation. The cable 230 can conduct signals from the ultrasound generator 237, via the energy transmission lines 232, for ultrasound imaging. The cable 230 can communicate transducer data from the transducer 221 to the ultrasound generator 237 via the transducer lines 232. The ultrasound generator 237 can generate ultrasound images (e.g., sonogram) from the transducer data. Accordingly, the cable 230 can conduct energy7and can also conduct data encoded in electrical signals. EnergyAttorney Docket No. :SUR.0129 WO conducted from the energy source 235 can interfere with data conducted from the transducer 221. For example, data communicated from the transducer to the ultrasound generator can be corrupted with noise by energy from the energy source such that ultrasound images generated from the transducer data by the ultrasound generator may be lower qualify and / or may include visual artifacts. Advantageously, the cable 230 can include shielding and / or grounding to reduce the effect of electrical interference on the transducer data to presene ultrasound image qualify. For example, shielding and / or grounding can reduce noise and / or minimize crosstalk (e g., electrical and / or acoustic) between transducer lines 232 and energy transmission lines 234.

[0073] As can be appreciated, that incorporation of the PCB 229 and PCB 233 within the reusable cable set 200 reduces the computational burden on the ultrasound generator 237, which is typically optimized for real-time ultrasound image reconstruction, beamforming, and rendering — tasks that are computationally heavy and time-sensitive. Offloading of such sensor processing to the reuseable cable set 200 also prevents interference with image frame rates or latency-critical imaging tasks. Incorporation of the PCB 229 and PCB 233 within the reusable cable set 200 also simplifies modularity and future upgrades in the system. That is, the processors 214, 219 in the reusable cable set 200 preprocess or standardize the sensor data prior to forwarding it to the ultrasound generator 237. If new imaging and treatment devices or new position / orientation-sensing technologies are introduced, only the reusable cable set 200 needs to be replaced or otherwise updated, rather than modifying the firmware and / or software of the ultrasound generator 237. Furthermore, by standardizing the format of the sensor data and processing pipeline in the reusable cable set 200, different ultrasound generator models can use the same imaging and treatment device type and reusable cable set 200 with minimal software adaption. Offloading of such sensor processing to the reuseable cable set 200 also minimizes data bandwidth and noise for the transmission of sensor data between the imaging and treatment device 220 and the ultrasound generator 237. The sensor data can be conditioned, filtered, and time-stamped closer to the source of the data before transmission to the ultrasound generator 237.

[0074] The imaging and treatment device 220 and / or cable 230 can include one or more foil shields 226. The foil shield 226 can be a thin layer of metallic material covering components in the imaging and treatment device 220 and / or cable 230. The foil shield 226 can be made of copper and / or tin or other metal or metal alloy. The foil shield 226 can shield components (e.g., transducer lines 232) from interference from electrical noise whichAttomey Docket No. :SUR.0129 WO can presen- e quality of transducer qualify data conducted from the transducer 221 to the ultrasound generator 237 for generating ultrasound images. In addition or as an alternative to foil shield 226, the imaging and treatment device 220 can include metallic paint (e.g., on connector), tin sheets, and / or shield cans that can cover the electronics.

[0075] The imaging and treatment device 220 and / or cable 230 can include one or more grounds 228 which can inhibit noise from interfering with transducer data. The grounds 228 can include electrical and / or mechanical ground connections. For example, the grounds 228 can mechanically couple the foil shields 226 with the transducer lines 232 and / or energy transmission lines 234. As another example, the grounds 228 can electrically ground the transducer lines 232 such as by electrically coupling the transducer lines 232 with a zero-ohm resistor. In this example, the transducer lines 232 are shown as being electrically grounded on the PCB 233. In some implementations, the transducer lines 232 can be electrically grounded on the handle PCB 227 or on the interconnect PCB 229. Electrically grounding the transducer lines 232 on the PCB 233 may provide improved noise reduction at least because the electrical grounding occurs nearest to the ultrasound generator 237. In some implementations, the transducer lines 232 can (each) be coupled with an inductor to improve signal to noise ratio.

[0076] FIG. 3A is a top perspective of an imaging and treatment device 301. The imaging and treatment device 301 has a proximal end 302 and a distal end 304. As discussed herein (e.g., in FIGS. 1 A-1B), a cable (e.g., cable 200 of FIG. 2A) can be connected to the imaging and treatment device 301 at the cable connection point 350 at the proximal end 302. The imaging and treatment device 301 comprises a handle 317. and elongate probe 319 connected to and distal to the handle 317, and an imaging transducer 321 connected to and distal to the elongate probe 319. During use, the handle 317 can be held by a user (e.g., a surgeon), and the distal end 304 (e.g., elongate probe 319) can be inserted transcervically into the uterus of a patient, for example, for imaging and / or treatment.

[0077] The distal end 304 of the imaging and treatment device 301 can comprise an imaging transducer 321 and a needle assembly (shown in FIGS. 5A, 6C and 6D). The imaging transducer 321 can be operably connected to the ultrasound generator (e.g., ultrasound generator 107 of FIG. 1A). The needle assembly can be operably connected to the energy source (e.g., energy source 105 of FIG. 1A). The imaging transducer 321 can be used to image tissue, for example, by comprising an ultrasound transducer that uses sonography. As described herein (e.g., in FIGS. 5A-5D), the imaging transducer 321 can articulate (e.g.,Attomey Docket No. :SUR.0129 WO rotate) to different angles relative to the elongate probe 319. For example, as show n in FIG.5B, the imaging transducer 321 can be substantially or nearly colinear with the elongate probe 319, which corresponds to an articulation angle of approximately 0°. As shown in FIGS. 5C and 5D, the imaging transducer 321 can articulate to, for example, 45° and 60° relative to the elongate probe 319. A smaller angle of articulation (e.g., closer to 0°) can be used to more easily insert the distal end 304 of the imaging and treatment device 301 into the uterus of a patient, or remove the device 301 therefrom. However, a larger angle of articulation (e.g.. more than 0°) can be used to more easily view target tissue within the uterus (e.g., a uterine fibroid).

[0787] The treatment element can be used to treat target tissue, for example, by ablating a fibroid. The treatment element can comprise a needle assembly (e.g., needle assembly 630 of FIG. 5 A), which can comprise an introducer (e.g., introducer 635 of FIG. 6C) and, optionally, needle electrodes, or tines (e.g., tines 633 of FIG. 6D). As shown in FIG. 6C, the introducer 635 can be reversibly extended or deployed from within the distal end 304 of the imaging and treatment device 301 into target tissue, for example a fibroid. As shown in FIG. 6D, the tines 633 can also be reversibly extended or deployed from within the distal end 304 of the imaging and treatment device 301 into target tissue, for example a fibroid. During ablation, energy (e.g., RF energy) from the energy source (e.g., energy source 105 of FIG. 1 A) can be transmitted through the needle assembly (e.g., the introducer 635 and / or tines 633) into the target tissue (e.g., a fibroid).

[0079] The handle 317 of the imaging and treatment device 301 comprises components that allow a user (e.g.. a surgeon) to manipulate the imaging transducer 321 and / or needle assembly at the distal end 304 during use. The handle 317 has a transducer articulation release (in the form of a manual actuator) 310, which is operably connected to the imaging transducer 321. The handle 317 also has a first slider 312 and a second slider 314, which are operably connected to the needle assembly. The sliders 312, 314 slide along a sliding track 316 on the handle 317. As shown in FIGS. 3B, 3D, and 3E, the sliders 312, 314 and sliding track 316 are on opposite sides of the handle, such that a slider on one side can be slid by a user’s thumb while the slider on the other side can be slid with a user’s index finger.

[0080] The transducer articulation release 310 in the handle 317 is operably connected to the imaging transducer 321 at the distal end 304, and is used to change the articulation angle of the imaging transducer 321. In the chain of operative connection between theAttorney Docket No. :SUR.0129 WO transducer articulation release 310 and the imaging transducer 321 is a spring that constantly provides a force on the imaging transducer 321. The spring can be a tension spring or a compression spring. One example of such a spring is the articulation spring 423 (shown in FIG. 4), which encircles the proximal portion of the linear articulator. The force exerted by the spring (e.g., by articulation spring 423) on the imaging transducer 321 is a straightening force, e.g., a force that would tend to decrease the angle of articulation. As shown in FIG. 4, the imaging transducer 321 can changeably engage (e.g., click into) one of a plurality of stable or locked predetermined positions or articulation angles. The predetermined positions or articulation angles can correspond to notches (e.g., 420a, 420b, 420c) in a linear articulator 422 within the handle 317, which can reversibly accommodate atooth 418 ofthe transducer articulation release 310. When the tooth 418 of the transducer articulation release 310 is engaged with a notch (e.g., first notch 420a, as shown in FIG. 4), thereby placing the transducer articulation release 310 in a secured state, the imaging transducer 321 will remain at a fixed articulation, even in response to the spring force or a direct application of a rotational force on the imaging transducer 321. Although certain embodiments described herein are directed to an imaging transducer that can move between or be biased toward a number of fixed articulation angles, in other embodiments the imaging transducer may be fixed or locked over a continuous range of articulation angles using a continuous locking mechanism.

[0081] Pushing down on the transducer articulation release 310 acts to disengage the tooth 418 from its notch 420, thereby placing the transducer articulation release 310 in an open state, and allowing the imaging transducer 321 to articulate in response to the direct application of a rotational force on the imaging transducer 321. For example, FIG. 4 shows a button spring 411 operably connected to the transducer articulation release 310. In some embodiments, the button spring 411 is biased to provide a force on the transducer articulation release 310 to engage the tooth 418 in a notch 420. Pushing down on the transducer articulation release 310 can compress the button spring 411 and disengage the tooth 418 from its notch 420. Absent other forces, the force of the articulation spring 423 on the imaging transducer 321 will articulate the imaging transducer 321 to a lesser degree of articulation. To increase the angle of articulation of the imaging transducer 321 while the tooth 418 of the transducer articulation release 310 is disengaged from any notches 420, a force is exerted on the curved surface of the imaging transducer 321, for example, by a surface, e.g., the tissue of a fibroid or of the uterine wall. Once the imaging transducer 321Attorney Docket No. :SUR.0129 WO is articulated to an angle desired by the user, the user can release the transducer articulation release 310. The button spring 411 will exert a force on the transducer articulation release 310, which will re-engage the tooth 418 with a notch 420. Beneficially, by requiring pressure (e.g., rotational force) between the imaging transducer 321 and a surface (e.g., uterine wall) to increase the angle of articulation of the imaging transducer 321, this articulation mechanism requires contact directly between the imaging transducer 321 and the surface. Beneficially, this reduces the incidence of air pockets developing between the imaging transducer 321 and the surface, which in turn improves imaging quality.

[0082] FIGS. 3 A, 4, 5B, 5C, and 5D provide a non-limiting, illustrative example of how the transducer articulation release 310 operates the articulation of the imaging transducer 321. As shown in FIG. 3A, the transducer articulation release 310 is part of the handle 317. As shown in FIG. 4, the transducer articulation release 310 has a tooth 418 that can engage notches 420 in the linear articulator 422. The linear articulator 422 is operably connected to the imaging transducer 321 at the distal end 304 by the articulation spring 423, which applies a straightening force on the imaging transducer 321. The first notch 420a (shown in FIG. 4) can correspond to a smallest articulation, for example, 0° of articulation, shown in FIG. 5B. The second notch 420b (shown in FIG. 4) can correspond to an intermediate articulation, for example, 45° of articulation, shown in FIG. 5C. The third notch 420c (shown in FIG. 4) can correspond to a largest articulation, for example, 60° of articulation, shown in FIG. 5D. For example, when the imaging transducer 321 articulates to increase the angle of articulation (e g., from 0° to 45°). the articulation spring 423 acts to move the linear articulator 422 towards the proximal end 302. This proximal-ward movement of the linear articulator 422 relative to the tooth 418 of the transducer articulation release 310 changes w hich notch 420 lines up with the tooth 418, for example from the first notch 420a to the second notch 420b. Conversely, when the imaging transducer 321 articulates to decrease the angle of articulation (e.g., from 45° to 0°). the articulation spring 423 acts to move the linear articulator 422 toward the distal end 304.

[0083] If the imaging transducer 321 starts with the tooth 418 of the transducer articulation release 310 engaged with the first notch 420a of the linear articulator 422, pressing the transducer articulation release 310 (to disengage the tooth 418 from the notch 420) absent other forces may not change the angle of articulation of the imaging transducer 321, since the imaging transducer 321 may already be as straight as it can be. To increase the angle of articulation, while the tooth 418 is disengaged from the notches 420, a force is exerted onAttorney Docket No. :SUR.0129 WO the curved surface of the imaging transducer 321, for example, by tissue, e g., the uterine wall or a fibroid. Once the user articulates the imaging transducer 321 to their liking, they can release the transducer articulation release 310 to re-engage the tooth 418 with the linear articulator 422. If the user articulated the imaging transducer 321 to an angle different from those corresponding to any of the notches, the articulation spring 423 will act to decrease the angle of articulation of the imaging transducer 321 until a notch 420 is engaged. For example, if the user articulated the imaging transducer 321 to 55°, the tooth 418 will be in between the second notch 420b (at 45° of articulation) and the third notch 420c (at 60° of articulation). The articulation spring 423 will act to straighten the imaging transducer, reducing the angle of articulation until the tooth 418 engages with the second notch 420b at 45° of articulation.

[0084] Although an embodiment of an imaging and treatment device has been described wherein the transducer articulation release 310 is in a secured state when the imaging transducer 321 is not articulated (that is, the tooth 418 engages the first notch 420a corresponding to 0° of articulation), in an alternative embodiment, it may be desirable for the transducer articulation release 310 to be in an open state when the imaging transducer 321 is not articulated (that is, the tooth 418 does not engage any notch). In this alternative embodiment, the transducer articulation release 310 does not need to be actuated or released to increase the articulation angle of the imaging transducer 321 ; the imaging transducer 321 can articulate in response to an application of pressure betw een the imaging transducer 321 and a surface. In this case, there may not be a notch 420a that would have otherwise defined the default (non-articulated) position of the imaging transducer 321. To prevent the imaging transducer 321 from articulating when the imaging and treatment device 301 is being introduced into the uterine cavity, the imaging and treatment device may further comprise a temporary locking mechanism 320 (shown in FIG. 3F) located on the handle 317 to prevent the imaging transducer 321 from articulating from its nominal position (e.g.. from a 0° articulation angle) in response to an application of pressure between the imaging transducer 321 and a surface (i.e., when rotational pressure is applied directly to the imaging transducer) and while the transducer articulation release 310 is in the open state. The temporary locking mechanism 320 may be temporarily affixed to the linear articulator 422, such that the linear articulator 422 may not linearly move relative to the handle 317. For example, the temporary locking mechanism 320 may have a forked end (not shown) that straddles the linear articulator 422. The temporary' locking mechanism 320 isAttorney Docket No. :SUR.0129 WO configured to be easily removed from the handle 317 (e.g., simply by pulling or tugging it) to allow the imaging transducer 321 to articulate when pressure (e.g., rotational force) is applied directly to the imaging transducer 321 by a surface (e.g., uterine wall). For example, the user may introduce the elongate probe 319 of the imaging and treatment device into the uterine cavity while the temporary locking mechanism 320 is installed in place on the handle 317 to prevent the imaging transducer 321 from articulating from its nominal position until it is ready to be operated. When ready to be operated, the user may then remove the temporary locking mechanism 320 from the handle 317. Once removed, and with the transducer articulation release 310 already in the open state, the imaging transducer 321 can be articulated by simply pressing it against the uterine wall to be imaged. The imaging and treatment device may then be operated as described above, e.g., the imaging transducer 321 can be locked into one of a plurality of predetermined positions or articulation angles (e.g., the tooth 418 may engage one of the notches 420b, 420c. such that the transducer articulation release 310 is in a secured state) and, if needed, actuating or releasing the transducer articulation release 310 to return it to an open state , thereby allowing the imaging transducer 321 to articulate again in response to an application of pressure against the uterine wall.

[0085] The handle 317 comprises a first slider 312 and a second slider 314, which are operably connected to the needle assembly. The sliders 312, 314 slide along a sliding track 316 on the handle 317. When the sliders 312, 314 are in their proximal -most position in the sliding track 316, the needle assembly 630 is retracted within the elongate probe, as shown in FIG. 5A. Sliding the first slider 312 along the sliding track 316 in the distal direction deploys the introducer 635 from the elongate probe 319, as shown in FIG. 6C. Sliding the second slider 314 along the sliding track 316 in the distal direction deploys the tines 633 from the elongate probe 319, as shown in FIG. 6D. Returning the second slider 314 proximally along the sliding track 316 incrementally retracts the tines 633 into the elongate probe 319. Returning the first slider 312 proximally along the sliding track 316 incrementally retracts the introducer 635 into the elongate probe 319.

[0086] FIG. 3B is a bottom perspective view of the proximal end 302 of the handle 317. As discussed above, the handle 317 has a cable connection point 350 configured to connect to a cable, e.g., configured to connect to the handle connector 201 of the reusable cable 200 shown in FIG. 2A. The cable connection point 350 includes a cable electrical connector 303, which is configured to electrically connect to the electrical connector 202 of theAttomey Docket No. :SUR.0129 WO reusable cable 200 shown in FIG. 2A. FIG. 3B also shows the first slider 312 and the second slider 314 of the handle 317, further disclosed above.

[0087] FIG. 3C is an exploded side view of the handle 317 of the imaging and treatment device 301. FIG. 3C shows a top component 317A of the handle 317 and a bottom component 317B of the handle 317. FIGS. 3D and 3E are exploded top views of the imaging and treatment device 301. A difference between FIGS. 3D and 3E is that FIG. 3D shows the exposed printed circuit board 360, while FIG. 3E does not. Like FIG. 3A, FIGS. 3C-3E shows the transducer articulation release 310 (which is operably connected to the imaging transducer 321) and the sliders 312, 314 (which are operably connected to the needle assembly). FIGS. 3C-3E also show how the device uses contactless methods to measure the angle of articulation of the imaging transducer 321 and the deployment of the needle assembly.

[0088] FIGS. 3C-3E show how the device uses contactless methods to measure the angle of articulation of the imaging transducer 321. As disclosed above and shown in FIG. 4, linear movement proximally or distally of the linear articulator 422 corresponds to changes in the articulation angle of the imaging transducer 321. The handle 317 also includes features to measure the articulation angle of the imaging transducer 321 in a contactless way (e.g., magnetically, optically, etc.). FIGS. 3C and 4 show an example in which magnets are used to measure the articulation angle of the imaging transducer 321. FIGS. 3C and 4 show an articulation magnet 324 attached to the linear articulator 422 and an articulation sensor 325 attached to the printed circuit board 360 within the handle 317. As the articulation angle of the imaging transducer 321 changes, the linear articulator 422 moves proximally / distally. The articulation magnet 324 moves proximally / distally with the linear articulator 422, causing the articulation magnet 324 to move relative to the articulation sensor 325. The articulation sensor 325 is a contactless sensor (e.g., a hall effect sensor) that measures with precision its distance from the articulation magnet 324. The articulation sensor 325 can measure continuous (e.g., not just discrete) changes in distance from the articulation magnet 324. As such, the articulation sensor 325 can measure continuous changes in the articulation angle of the imaging transducer 321 (i.e., continuously track articulation of the imaging transducer 321) . For example, as the linear articulator 422 and the articulation magnet 324 move relative to the articulation sensor 325, the sensor 325 can measure the changing distance between itself and the articulation magnet 324 and thereby measure the corresponding articulation angle of the imaging transducer 321 to a precisionAttomey Docket No. :SUR.0129 WO of, for example, within 5 degrees, within 3 degrees, within 2 degrees, or within 1 degree. The precision of this contactless measurement system is finer - more granular - than merely knowing which notch 420 is engaged by the tooth 418 of the transducer articulation release 310. The articulation angle information can be sent to a display (e.g., display 109 shown in FIG. 1A).

[0089] FIGS. 3C-3E show how the device uses contactless methods to measure the deployment state of the needle assembly. As disclosed above and shown in FIG. 3A, sliding the first slider 312 distally corresponds to deployment of the introducer 635, and sliding the second slider 314 distally corresponds to deployment of the tines 633. As shown in FIG.3E, a first carriage magnet 313 is fixed to the first slider. As shown in FIG. 3E, a second carriage magnet 315 is fixed to the second slider. As the first or second sliders 312, 314 move distally or proximally, the first or second carriage magnet 313, 315, respectively, move as well. FIG. 3D show s a plurality of carriage sensors 318, which can be similar to the articulation sensor 325.

[0090] A plurality of carriage sensors 318a, 318b are show n along the path the first carriage magnet 313 travels when slid. As the first slider 312 slides distally with the first carriage magnet 313, the proximal carriage sensor 318a will measure the movement of the first carriage magnet 313. As the first carriage magnet 313 is slid further distally, the next carriage sensor 318b will measure the movement of the first carriage magnet 313. The carriage sensors 318a, 318b are positioned such that at least one of the sensors can measure its distance from the first carriage magnet 313. By always being able to measure the position of the first carriage magnet 313, the carriage sensors 318a, 318b indirectly measure the deployment of the introducer 635, shown in FIG. 6C. Said differently, the carriage sensors 318a, 318b track the position (e.g., deployment) of the introducer 635. The position information of the introducer 635 can be sent to a display (e.g., display 109 shown in FIG.1A).

[0091] A plurality of carriage sensors 318c, 318d, 318e are shown along the path the second carriage magnet 315 travels when slid. As the second slider 314 slides distally with the second carriage magnet 315, the proximal carriage sensor 318c will measure the movement of the second carnage magnet 315. As the second carriage magnet 315 is slid further distally, the next carriage sensor 318d will measure the movement of the second carriage magnet 315, and so on. The carriage sensors 318c, 318d, 318e are positioned such that at least one of the sensors can measure its distance from the second carriage magnet 315. ByAttorney Docket No. :SUR.0129 WO always being able to measure the position of the second carriage magnet 315, the carriage sensors 318c, 318d, 318e indirectly measure the deployment of the tines 633, shown in FIG. 6D. Said differently, the carriage sensors 318c, 318d, 318e track the position (e.g., deployment) of the tines 633. The position information of the tines 633 can be sent to a display (e.g., display 109 shown in FIG. 1A).

[0092] FIG. 3D shows two carriage sensors 318a, 318b used to track the deployment of the introducer 635 and three carriage sensors 318c, 318d, 318e used to track the deployment of the tines 633. In FIG. 3D, the carriage sensors 318a. 318b used to track the introducer 635 are placed along the printed circuit board 360 in positions more proximal than those sensors 318c, 318d, 318e used to track the tines 633. The introducer-tracking sensors 318a, 318b are placed more proximally than the tine-tracking sensors 318c, 318d, 318e because the introducer 635 does not deploy as far as the tines 633 do. Said differently, the tines 633 travel a greater distance when deployed than the introducer 635 does, so it can be desirable to have the tine-tracking sensors 318c, 318d, 318e positioned more distally along the printed circuit board 360 than the introducer-tracking sensors 318a, 318b.

[0093] FIG. 3D shows the printed circuit board 360 to which the articulation sensor 325 and carriage sensors 318 are attached. The information from the printed circuit board 360 can be transferred to the cable when the cable is electrically connected to the cable electrical connector 303 of the cable connection point 350 shown in FIG. 3E. Also attached to the printed circuit board 360 are storage component 366 and hardware processors 368. The hardware processors 368 can process the information collected by the contactless sensors (e.g., articulation sensor 325 and carriage sensor(s) 318).

[0094] In some embodiments, the printed circuit board 360 can also include an analog to digital converter (ADC) that converts analog sensor voltages to digital signals, which can be transmitted to PCB 219 in the cable. In some embodiments, the ADC can be a smart ADC, which can request data from sensors individually. In some embodiments, the ADC cannot read the EEPROM, to protect the right to the EEPROM. In some implementations, the ADC can be located in the cable, such as on PCB 217 and / or may be located in an ultrasound generator such as in combination with hardware processors 123, or other computing device remote to or separate from the imaging and treatment device 301.

[0095] The storage component 366 can include any computer readable storage medium and / or device (or collection of data storage mediums and / or devices), including, but not limited to, one or more memory7devices that store data, including without limitation,Attorney Docket No. :SUR.0129 WO dynamic and / or static random-access memory (RAM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), memory circuits (e.g., solid state drives, random-access memory (RAM), etc.), and / or the like. The storage component 366 can store data relating to, and useable for, the operation of the imaging and treatment device 301. For example, the storage component 366 can store program instructions that when executed by the hardware processor 368 cause the imaging and treatment device 301 to perform one or more operations. As another example, the storage component 366 can store calibration data for the imaging and treatment device 301 such as for the non-contact sensors (e.g., articulation sensor 325 and / or carriage sensors 318).

[0096] In some implementations, the storage component 366 is an EEPROM that can be programmed by hardware processors in a reusable cable such as hardware processors 214 and / or 219 shown and / or described herein. For example, hardware processor 219 can program the storage component 366 with calibration data for operating the non-contact sensors (e.g., articulation sensor 325 and / or carriage sensors 318). In some implementations, the storage component 366 can only be programmed (e.g., written to) once and re-programming the storage component 366 may not be possible. Accordingly, the storage component 366 can be programmed to be used a single time, and then may not be able to be reprogrammed for subsequent use (e.g., during subsequent procedures). For example, hardware processors in the reusable cable can program the storage component 366 when the reusable cable is connected with the imaging and treatment device to allow the imaging and treatment device to operate properly during a procedure. Programming the storage component 366 can include writing data to the storage component 366 including calibration data, unique data, and / or encrypted data. Encrypted and / or unique data can prevent the storage component 366 and / or imaging and treatment device 301 from being reused. When the reusable cable is disconnected from the handle 317. the storage component 366 may not be able to be reprogrammed if the imaging and treatment device 301 were reconnected with the reusable cable thus preventing the handle 317 from operating, or at least operating properly, for a subsequent procedure. Thus, the nonprogrammable nature of the storage component 366 may serve as a lockout mechanism by inhibiting reuse of the imaging and treatment device 301 during subsequent procedures.

[0097] The imaging and treatment device 301 can include additional and / or alternative lockout mechanism for preventing the imaging and treatment device 301 from being reusedAttorney Docket No. :SUR.0129 WO for multiple different procedures on different patients. The lockout mechanism(s) can be mechanical and / or electrical. For example, the imaging and treatment device 301 can include a wire or fuse that breaks upon disconnection of the reusable cable from the imaging and treatment device 301. Breaking the wire or fuse can disrupt an electrical connection necessary for operation of the imaging and treatment device 301. As another example, the handle 317 can include a one-way connector that can connect to reusable cable but that destroys the one-way connector upon disconnection.

[0098] FIG. 4 is a cutaway side view of the imaging and treatment device 301. As disclosed above, FIG. 4 illustrates the how the transducer articulation release 310 can articulate the imaging transducer 321. As disclosed herein, the transducer articulation release 310 comprises a tooth 418 that engages one of a plurality of notches 420 of a linear articulator 422. The tooth 418 can be biased to engage one of a plurality of notches 420 by a button spring 411. The linear articulator 422 is operatively connected to the imaging transducer 321 by an articulation spring 423, which can be placed over the proximal portion of the linear articulator 422. The linear articulator 422 is also fixed to the articulation magnet 324, which moves proximally and distally with the linear articulator 422 as the articulation angle changes. FIG. 4 also shows the articulation sensor 325. which measures its distance from the articulation magnet 324 and can thereby be used to calculate the articulation angle of the imaging transducer 321. The information regarding the articulation angle of the imaging transducer 321 can be sent to the cable and ultimately to a display, which can be viewed by a user (e.g., a surgeon).

[0099] FIG. 4 shows the default position to which the articulation spring 423 is biased. The default position can be a position of minimal articulation (e.g., a position in which the imaging transducer 321 is co-linear or nearly co-linear with the elongate probe 319, which is shown in FIG. 5A). The default position of the imaging transducer 321 can correspond to the tooth 418 engaging the first notch 420. The default position of the imaging transducer 321 can correspond to an articulation angle of, for example, 0°, 5°, 10°, 15°, or 20°.

[0100] To increase the articulation angle, a user can push down on the transducer articulation release 310, which can compress a button spring 411, and exert a rotational force on the imaging transducer 321, for example from a surface (e.g., a uterine wall). To decrease the articulation angle, a user can push down on the transducer articulation release 310 absent other external forces on the imaging transducer 321. The articulation spring 423 will decrease the articulation angle.Attomey Docket No. :SUR.0129 WO

[0101] The plurality of notches 420 determines which angles the imaging transducer 321 can click or reversibly lock into. For example, the tooth 418 being engaged in the first notch 420a can correspond to the default position of the imaging transducer, as shown in FIGS.5 A and / or 5B. The tooth 418 being engaged in the second notch 420b can correspond to a second articulation angle, such as 45°, shown in FIG. 5C. The tooth 418 being engaged in the third notch 420c can correspond to a third articulation angle, such as 60°, shown in FIG.5D. It will be understood that there can be more or few er than three notches. It will also be understood that the angles of articulation associated with each notch can be tuned by the manufacturer.

[0102] In some embodiments, including in FIG. 4, the imaging transducer 321 can reversibly lock into a discrete set of articulation angles. For example, in FIG. 4, the imaging transducer 321 can reversibly lock into three discrete articulation angles, each angle with its own corresponding notch 420. In some embodiments, the imaging transducer 321 can reversibly lock into more than three discrete articulation angles. In some embodiments, the imaging transducer 321 can lock at any desired articulation angle. In some embodiments, the imaging transducer 321 can lock or stably hold continuously with movement, at any articulation angle.

[0103] FIGS. 5A-5D show' the imaging transducer 321 at different angles of articulation. FIG. 5 A shows an angle of articulation of approximately 15°. FIG. 5B show s an angle of articulation of approximately 0°. Both 15° and 0° can be default positions, which correspond to the tooth 418 shown in FIG. 4 engaging with the first notch 420a. FIG. 5C shows an angle of articulation of approximately 45°. which can correspond to the tooth 418 shown in FIG. 4 engaging with the second notch 420b. FIG. 5D shows an angle of articulation of approximately 60°, which can correspond to the tooth 418 shown in FIG. 4 engaging with the third notch 420c.

[0104] FIG. 5A also shows the needle assembly 630 fully retracted into the elongate probe 319. As disclosed herein, the needle assembly 630 can comprise an introducer (e.g., introducer 635 shown in FIG. 6C) and tines (e.g., tines 633 shown in FIG. 6D). The needle assembly 630 can be reversibly deployed from the elongate probe 319, for example, into target tissue (e.g., a fibroid) to be ablated.

[0105] FIG. 6A illustrates an imaging and treatment component 600 which may be used to treat a fibroid F located in the myometrium M in a uterus U beneath a uterine wall UW (the endometrium) and surrounded by the serosal w all SW. The imaging component 600 can beAttomey Docket No. :SUR.0129 WO introduced transvaginally and transcervically (or alternately laparoscopically) to the uterus U, and the imaging transducer 607 deployed to image the fibroid F within a field of view indicated by the broken lines.

[0106] FIG. 6B shows an image that can be visible on a display (e.g. display 109 shown and / or described herein), showing safety boundary (SB) and treatment boundary (TB), in accordance with some embodiments. Prior to treatment, the user (e.g., a physician) can change the size and / or position of the boundaries TB and SB for proper treatment.

[0107] FIGS. 6C-6D show the imaging and treatment device 600 as present in the patient in combination with the image present on the display during a treatment procedure. As shown in FIG. 6C, the introducer 635 can extend from the imaging and treatment device 600 into the fibroid F. As shown in FIG. 6D The tines 633 can extend from the imaging and treatment device 600 into the fibroid F. Energy can be supplied to the tines 633 (and optionally to the introducer 635) to ablate the fibroid F within the boundary depicted by the virtual treatment boundary TB.

[0108] FIG. 7 illustrates an example user interface 700 providing a visualization to a user of the orientation of an imaging and treatment device during a procedure. A computing device, such as ultrasound generator 107, and / or any of the other computing devices shown and / or described herein, can generate user interface data for rendering the user interface 700. The user interface 700 can be displayed on a display screen such as a display screen of an ultrasound generator. For example, user interface 700 can be displayed on display 109 shown and / or described herein. In some implementations, user interface 700 can be displayed on a screen of other devices, such as a laptop, tablet, smartphone, etc.

[0109] User interface 700 includes a graphical annulus 701 and a graphical device representation 703. The graphical device representation 703 may be an avatar that graphically represents, or is otherwise visually similar to, an imaging and treatment device, such as any of the imaging and treatment devices shown and / or described herein. The graphical annulus 701 can be a ring, such as a circle or oval extending around the graphical device representation 703. The graphical annulus 701 has a center 707. The graphical device representation 703 can include a transducer, an elongate probe, and / or a handle. The graphical device representation 703 can be positioned at the center 707 of the graphical annulus 701. For example, the transducer of the graphical device representation 703 can be positioned at the center 707. A longitudinal axis 709 of the graphical device representation 703 can extend through the center 707 of the graphical annulus 701. The user interface 700Attomey Docket No. :SUR.0129 WO can show the graphical device representation 703 as rotating about the longitudinal axis 709.

[0110] The user interface 700 includes orientation markers 711A-711B positioned at various locations on the graphical annulus 701. The orientation markers 711A-711B may differ from each other to distinguish various positions on the graphical annulus 701. In this example, the orientation markers 711A-711B are each different numbers (e.g., 3, 6, 9, 12, respectively) that correspond to the positions on a clockface. In some implementations, the orientation markers 711A-711B can be letters, words (Left, Posterior, Right, Anterior) or shapes or other symbols to differentiate various positions on the graphical annulus 701. Accordingly, the user interface 700 may provide a visual indication to a user of the orientation of the graphical device representation 703 by associating the direction of orientation with the orientation markers 711-71 IB.

[0111] In this example, the user interface 700 includes a direction indicator 713 extending from a tip of the graphical device representation 703 (e.g., the transducer) to the graphical annulus 701. The direction indicator 713 can provide a more precise indication of the orientation of the graphical device representation 703 by providing an exact location on the graphical annulus 701 to which the graphical device representation 703 is pointing. In some implementations, the user interface 700 may not include a direction indicator 713.

[0112] In this example, the user interface 700 includes ultrasound representations 715. The ultrasound representations 715 can include waves or arcs extending from the tip of the graphical device representation 703 (e.g., the transducer) toward the graphical annulus 701. The user interface 700 can include the ultrasound representations 715 during an ultrasound (e.g., when the transducer of the imaging and treatment device is emitting sound waves). The user interface 700 may not include the ultrasound representations 715 when an ultrasound is not occurring. Accordingly, user interface 700 can provide a real-time visualization to a user of whether the intrauterine probe is effectuating ultrasound during a procedure.

[0113] A computing device generating user interface data for rendering user interface 700 can generate the user interface data based on at least information originating from an imaging and treatment device. For example, the computing device can access sensor data (e.g., from inertial sensor 213). ultrasound information (e.g., indicating whether ultrasound is occurring), and / or ablation information (e.g., indicating whether ablation is occurring, strength of RF energy' of the ablation, ablation duration, etc.) and can generate user interfaceAttorney Docket No. :SUR.0129 WO data for rendering user interface 700 from such information. The user interface 700 can update the orientation of the graphical device representation 703 to correspond with the orientation of the imaging and treatment device. The graphical device representation 703 orientation can be updated in real-time based on inertial data originating from inertial sensors in the imaging and treatment device (e.g., in the handle and / or cable such as inertial sensor 213). Accordingly, user interface 700 can provide a real-time visualization of the orientation of the imaging and treatment device during a procedure.

[0114] FIGS. 8A-8B illustrate example implementations of an imaging and treatment device 801 positioned in a uterus 800. As shown, the imaging and treatment device 801 can be oriented in various directions during a procedure. For example, the imaging and treatment device 801 can be oriented in a first direction as show n in FIG. 8 A (such as when treating fibroid 803A) and can then be oriented in a second direction as shown in FIG. 8B (such as when treating fibroid 803B). As shown and / or described in FIG. 7, user interface 700 can update (e.g., in real-time based on sensor data), to provide a visualization of the imaging and treatment device 801 within the uterus 800. For example, when the imaging and treatment device 801 is oriented toward the left as shown in the FIG. 8A, user interface 700 can update the orientation of the graphical device representation 703 to be directed toward the left side of the graphical annulus 701 (e.g., toward orientation marker 711C).When the imaging and treatment device 801 is oriented toward the right, as shown in the FIG. 8B, user interface 700 can update the orientation of the graphical device representation 703 to be directed toward the right side of the graphical annulus 701 (e.g., toward orientation marker 711A). As additional examples, when the imaging and treatment device 801 is oriented to point out of the page, user interface 700 can update the orientation of the graphical device representation 703 to be directed toward the top side of the graphical annulus 701 (e g., toward orientation marker 71 ID) and when the imaging and treatment device 801 is oriented to point into the page, user interface 700 can update the orientation of the graphical device representation 703 to be directed toward the bottom side of the graphical annulus 701 (e.g., toward orientation marker 71 IB).

[0115] FIGS. 9A-9B illustrate an example user interface 900A, 900B showing an ultrasound image 901. A computing device, such as ultrasound generator 107, and / or any of the other computing devices shown and / or described herein, can generate user interface data for rendering the user interface 900A, 900B. The user interface 700 can be displayed on a display screen such as a display screen of an ultrasound generator. For example, userAttorney Docket No. :SUR.0129 WO interface 900A, 900B can be displayed on display 109 shown and / or described herein. In some implementations, user interface 900A, 900B can be displayed on a screen of other devices, such as a laptop, tablet, smartphone, etc.

[0116] User interface 900A includes an orientation graphic 903 positioned adjacent to the ultrasound image 901. The orientation graphic 903 can include similar structural and / or operational features as user interface 700. For example, the orientation graphic 903 can update in real-time during a procedure to provide a visualization of the imaging and treatment device orientation and / or other ablation information. The orientation graphic 903 includes a treatment map in the form of ablation markers 905 that are positioned relative to the graphical device representation 703. In the illustrated embodiment, the ablation markers 905 are positioned around a perimeter of the orientation graphic 903, for example, on the annular perimeter of the clockface. The ablation markers 905 indicate locations where fibroid ablation has occurred. In this example, the orientation graphic 903 includes four ablation markers 905. The number of ablation markers 905 can vary depending on how many ablation events have occurred. A user can select the orientation graphic 903 to view additional information such as shown and / or described in FIG. 9B.

[0117] User interface 900B includes ablation information 907 which can be displayed responsive to user selection of orientation graphic 903. Ablation information 907 includes information relating to ablations that have taken place during a procedure. In this example, the ablation information 907 is arranged into rows and columns although other arrangements are contemplated within the scope of this disclosure. The ablation information 907 includes columns of data corresponding to ablation event, ablation size, ablation volume, treatment duration, and ablation orientation. Two rows of data are shown each corresponding to a separate ablation event. The user can visualize additional rows of data for other ablation events (if any) by scrolling down through the ablation information 907. In this example, the first row shows that for ablation event #1, the size of the ablation was 2.0 x 1.4 cm, the volume was 2.1cc, the time was 01:18 / 01:18. The first row also includes an orientation graphic providing a visualization of the location of the ablation (which may correspond, at least partially, to orientation graphic 903). In some implementations, the ablation information 907 can include additional information such as whether the ablation was completed or whether additional ablating is needed to effectively treat a fibroid. A computing device can determine the ablation information 907 based on at least information originating from an imaging and treatment device. For example, theAttomey Docket No. :SUR.0129 WO computing device can access sensor data (e.g., from inertial sensor 213) and / or ablation information (e.g., indicating whether ablation is occurring, strength of RF energy' of the ablation, ablation duration, etc.) and can generate user interface data for rendering user interface 900 based on such information.

[0118] Disclosed herein are various computational processes, including e.g., monitoring tissue morphology, serosa tracking and shadow removal, dynamic image processing, tissue impedance tracking, passive cavitation detection, which can be executed by one or more hardware processors, whether they are associated with a singular or multiple computing devices / systems, and even devices in remote or wireless communication, such as any of the computing devices / systems shown and / or described herein. For example, hardware processor 123 of the ultrasound generator 107 can perform any of the computational processes disclosed herein, in whole or in part.

[0119] For example, relevant to computational processes involving monitoring tissue morphology, denaturing tissue (e.g., fibroids), such as from thermal treatment as in ablation, can change the characteristics of the tissue, such that the ultrasound properties of the tissue change. For example, ablating tissue can change the acoustic impedance of the tissue. Acoustic impedance can be described by the following equation: Z= rho*c; where Z is the acoustic impedance, rho is the density of tissue and c is the speed of sound.

[0120] Accordingly, thermally denaturing or ablating tissue can change the tissue morphology (e.g., density', speed of sound through the tissue) which in turn can change the resulting images of the tissue such that tissue morphology can be tracked with one or more imaging techniques such as ultrasound based elastography. acoustic thermometry, and / or ultrasound speckle tracking. Elastography measures tissue stiffness, which can change from ablation. In some aspects a computing device can measure elastography using acoustic radiation force imaging (ARFI), thermal strain imaging (TSI), and / or shear wave elastography imaging (SWEI). Acoustic thermometry’ measures changes in tissue temperature which can result from ablation. Ultrasound image speckles represent heterogeneity in the tissue indicative of tissue characteristics, which can change from ablation. A computing device can track speckles (with correlation and / or cross correlation) to track changes in tissue characteristics (e.g., sound speed, temperature, stiffness).

[0121] As an example, a computing device can automatically distinguish between different tissue types based on determining tissue stiffness using ultrasound based elastography. The computing device could thus automatically identify healthy tissue, benign tumors,Attorney Docket No. :SUR.0129 WO malignant tumors, etc. Advantageously, a user can avoid treating tissue that should not be treated. As another example, a computing device can automatically identify and monitor tissue features with one or more imaging techniques before, during, and after treatment. The computing device can monitor changes in morphology of these features to monitor whether tissue has been treated. For example, the computing device can generate a user interface for display to a user wherein tissue features change color based on changes in tissue morphology (e.g., changes in stiffness as determined using elastography, changes in thermometry as determined using acoustic thermometry, etc ). Various tissue regions could be displayed as various colors to indicate whether the tissue is untreated, partially treated, and / or fully treated. Other indicators could also be displayed such as words, letters, numbers, check marks and / or colors, etc., overlaid onto or adjacent to the displayed tissue image, to indicate the progress of tissue treatment and / or to provide an indication to the user of whether or not a fibroid or other tissue region has been treated. Advantageously, a user can avoid treating tissue that has already been treated. In some implementations, the computing device can automatically determine from the imaging techniques whether to continue treating the tissue or whether to stop and can indicate such to the user. Monitoring changes in tissue morphology can improve treatment efficacy.

[0122] Relevant to computational processes involving serosa tracking and shadow removal, the introducer 635 and / or electrodes 633 can be deployed adjacent to the imaging transducer 607, as shown in FIGS. 6C-6D. The introducer 635 and / or electrodes 633 can obstruct the ultrasound waves emitted from and / or detected by the transducer 607 which can interfere with the imaging of objects behind the introducer 635 and / or electrodes 633. In other words, the introducer 635 and / or electrodes 633 can block the view of objects behind them, causing a “shadow effect”. As an example, the introducer 635 and / or electrodes 633 can block the view of the serosa (the outer layer of tissue that covers the uterus), endometrial lining, and / or fibroid edges, as shown and / or described in FIG. 11B. Moreover, visualizing fibroid perimeters can be difficult due to poor penetration depth and / or low signal to noise ratio. Thus, ensuring that ablation remains within safety boundaries (e.g., outside of a shadowed area and / or within a serosa) can be difficult if images are blocked with shadows.

[0123] FIG. 10 shows a user interface 1100 displaying an ultrasound image 1101 of a uterus showing the serosa 1103. In this example, the serosa 1103 is unobstructed by shadows and thus extends throughout the ultrasound image 1101 from the left side of the image to theAttorney Docket No. :SUR.0129 WO right side of the image. The serosa 1103 may be unaffected by shadows because an introducer and / or electrodes are not deployed and thus do not obstruct the view of the imaging transducer. A computing device can implement a serosa tracker to track the position of the serosa 1103 to avoid ablating too close to the serosa 1103, perforating the serosa 1103, etc., particularly when the serosa 1103 is obstructed by shadows. Although various examples are shown and / or described herein with reference to tracking a serosa, similar examples are contemplated for tracking other structural markers, such as endometrial lining, fibroid edges, etc., to mitigate the shadow effect.

[0124] The computing device can perform a calibration to determine the position of the serosa. The calibration can include a transducer scan of a region of interest at multiple plane views (angles) axially and transaxially prior to deploying the introducer and / or electrodes. Performing the transducer scan prior to deployment may be difficult at least because the introducer is not deployed into the uterus to anchor the imaging device during the scan. Thus, the computing device can access inertial data from an inertial sensor of the imaging device during the transducer scan which may facilitate determining the pose of the imaging device during the scan (since the imaging device is not anchored with the introducer). Because the introducer and / or electrodes are not deployed during the calibration transducer scan, the images from the transducer scan may not be useable to confirm estimated ablation location (as in FIGS. 11D-11E for safety rotation), however the serosa 1103 will advantageously not be occluded from view by the shadow effect. An example transducer scan can include rotating the imaging device to a plurality of poses (angular positions), for example, the left (e.g.. to a 90 degree angle) while obtaining images and then rotating the imaging device to the right (e.g., to a 90 degree angle) while obtaining images. The computing device can indicate to a user to move the imaging device to perform the transducer scan for the calibration. User interface 1100 includes an example imaging device representation 1105 indicating to a user to rotate the imaging device to perform the transducer scan. The computing device can determine whether a user is completing a transducer scan, or individual steps thereof, form inertial data originating from inertial sensors associated with the imaging device or responsive to actuation of the actuator 308.

[0125] The computing device can determine the position of the serosa 1103 from the images obtained during the transducer scan which advantageously do not include shadows. The computing device can identify the serosa 1103 with an edge detection technique. In some implementations, the computing device can provide the images from the transducerAttomey Docket No. :SUR.0129 WO scan to a machine learning model configured to identify the serosa 1103 and determine its position. The machine learning algorithm can be trained to identify the serosa 1103 with pre-existing image data from one or more patients and / or live image data obtained during a procedure (e.g., from the transducer scan of the calibration). As discussed, the machine learning model can be trained with pre-existing and / or live image data to identify other structural features such as endometrial lining and / or fibroid edges. The machine learning model, in various aspects, can be implemented on the computing device, in whole or in part, or can be implemented on a separate device in remote communication with the computing device, in whole or in part.

[0126] Pursuant to identifying the position of the serosa 1103, the computing device can generate indicia of the serosa 1103 position. FIG. 11A shows an example serosa tracker 1107 which is superimposed on the ultrasound image 1101 over the serosa 1103. The serosa tracker 1107 can help prevent the user from accidentally perforating the serosa 1103 during ablation particularly when shadows obstruct the view of the serosa 1103. As shown in FIG.1 IB, an introducer 1111 is deployed into the uterus. The introducer 1111 obstructs the view of the serosa 1103 (e.g., casts a “shadow” on the serosa 1103) such that the shadowed serosa portion 1109 is no longer visible or is at least partially obstructed from view. Thus, as shown in FIG. 11C, the serosa tracker 1107 can facilitate monitoring the position of the serosa 1103 even when at least partially obstructed from view due to shadow effect of the introducer 1111.

[0127] FIG. 11D shows the user interface with treatment boundary 1113 A and safety boundary 1113B superimposed on the ultrasound image 1101. Treatment boundary 1113A can indicate a region that is estimated to be ablated. Safety boundary 1113B can indicate a region beyond the treatment boundary 1113A wherein ablation occurs but that still may be thermally affected by the ablation. The computing device can generate the boundaries 1113 A. 1113B based on user input via the imaging and treatment device. A user can control size and / or location of boundaries 1113A, 1113B via input on the imaging and treatment device. Additional details regarding generating and controlling boundaries 1113 A, 1113B are disclosed in U.S. Pat. Nos. 11,219,483 and 9,861,336 each of which are incorporated herein in their entirety for all purposes. The computing device can generate or adjust the boundanes 1113A, 1113B before the introducer 111 is deployed.

[0128] Once the introducer 1111 is deployed, the computing device can initiate a transducer scan for a safety rotation to confirm the boundaries 1113 A, 1113B are safely positioned inAttorney Docket No. :SUR.0129 WO all planes of view. The safety rotation transducer scan can be a similar process as the transducer scan for the calibration shown and / or described herein. For example, the imaging device representation 1105 can indicate to a user to rotate the imaging device while the imaging device obtains images of the region of interest. The imaging device can be rotated about a central axis (e.g., the axis of the introducer 1111). The safety rotation transducer scan may be performed after the introducer 1111 has been deployed and thus images obtained during the safety rotation may have shadows. In some cases, the safety¬ rotation transducer scan is performed before the electrodes are deployed.

[0129] Ensuring that boundary 1113A and / or 1113B are distanced from the serosa 1103, or at least do not intersect serosa 1103, in all planes of view, can reduce the likelihood of perforating the serosa 1103 when deploying electrodes, or damaging the serosa 1103 during ablation. FIG. 11D illustrates an example where safety boundaries 1113A, 1113B are positioned safely away from the serosa 1103 such that the ablation procedure can safely continue. FIG. HE illustrates an example where safety boundaries 1113A, 1113B are dangerously positioned adjacent to the serosa 1103 (e.g., intersect with the serosa 1103) such that continuing with the ablation procedure poses significant risk of damaging the serosa 1103. Thus, user interface 1100 can advantageously provide visual feedback to a user during an ablation procedure (e.g., prior to ablating) for the user to determine whether the serosa 1103 will be affected by the ablation even when the shadowed serosa portion 1109 is not viewable to the user. The user can adjust the size and / or location of boundaries 1113A, 1113B via the imaging and treatment device to ensure the boundaries 1113 A, 1113B are safely positioned relative to the serosa 1103. Ensuring proper boundary positions can ensure proper placement (or expected placement) of the introducer 1111 and / or electrodes to avoid damaging the serosa 1103. In some implementations, the computing device can automatically determine whether the boundaries 1113A, 1113B are safely positioned relative to the serosa 1103 and / or serosa tracker 1107. For example, the computing device can compare positions of the boundaries 1113A, 1113B with the position of the serosa tracker 1107 (each of which the computing device may have previously determined) to make the determination of proper positioning. The computing device can determine that the boundaries 1113 A, 1113B are safely positioned if boundary 1113 A and / or 1113B are separated from the serosa tracker 1107 by a minimum distance, or in some cases do not intersect the serosa tracker 1107. The computing device can generate various indications for when the boundaries 1113 A, 1113B are properly or improperlyAttomey Docket No. :SUR.0129 WO positioned, respectively. In some implementations, the computing device can inhibit a procedure from continuing when the boundaries 1113A, 1113B are improperly positioned. In some implementations, a user can override the computer's determination.

[0130] In some aspects, the computing device can construct and / or enhance the portion of the image obstructed by the shadow. This may be referred to as shadow removal. For example, the computing device can construct a view of the serosa 1103 to fill in and / or enhance the shadowed serosa portion 1109. The computing device can construct a view of the shadowed serosa portion 1109 based on combining a plurality of images from various view angles obtained during a transducer scan using 3D image stitching techniques. The transducer scan may have been performed during a safety rotation after the introducer 1111 was deployed.

[0131] FIG. 12 shows an example imaging and treatment device 1201 configured to reduce the shadow effect in images obtained with the device 1201. As shown, the imaging and treatment device 1201 includes an imaging transducer 1221 positioned at the distal end of an elongate probe 1219, and an introducer 1235 that can extend distally from the elongate probe 1219. Introducer axis 1203 is superimposed over the imaging and treatment device 1201 and represents the longitudinal axis of the introducer 1235. For example, the introducer 1235 extends along the introducer axis 1203 when the introducer 1235 extends from the elongate probe 1219. Transducer plane 1202 is superimposed over the imaging and treatment device 1201 and represents a plane that extends longitudinally along the midline of the transducer 1221 and that bisects the transducer 1221 in two halves. Transducer plane 1202 is shown as extending into and out of the page. The introducer axis 1203 is offset from the transducer plane 1202. In this example, the transducer plane 1202 and the introducer axis 1203 are non-parallel and separated by an angle 0 (e.g., introducer axis 1203 intersects transducer plane 1202). The angle 0 can be between 1° and 20°, between 1° and 10°, between 3° and 7°, or about 5°. Because the introducer axis 1203 is offset from the transducer plane 1202, the degree to which the introducer 1235 obstructs the transducer 1221 may be reduced, thus also reducing the likelihood of shadow s in images obtained with the transducer 1221.

[0132] FIG. 13 shows an example imaging and treatment device 1301 configured to reduce the shadow effect in images obtained with the device 1301. As shown, the imaging and treatment device 1301 includes an imaging transducer 1321 positioned at the distal end of an elongate probe 1319, and an introducer 1335 that can extend distally from the elongateAttorney Docket No. :SUR.0129 WO probe 1319. Introducer axis 1303 is superimposed over the imaging and treatment device 1301 and represents the longitudinal axis of the introducer 1335. For example, the introducer 1335 extends along the introducer axis 1303 when the introducer 1335 extends from the elongate probe 1319. Transducer plane 1302 is superimposed over the imaging and treatment device 1301 and represents a plane that extends longitudinally along the midline of the transducer 1321 and that bisects the transducer 1321 in two halves. Transducer plane 1302 is shown as extending into and out of the page. The introducer axis 1303 is offset from the transducer plane 1302. In this example, the transducer plane 1302 and the introducer axis 1303 are parallel and separated by a distance (d). The distance can be between 0.2mm and 3.0mm, between 0.5mm and 2mm, between 0.8mm and 1.2mm, or about 1mm. Because the introducer axis 1303 is offset from the transducer plane 1302, the degree to which the introducer 1335 obstructs the transducer 1321 may be reduced, thus also reducing the likelihood of shadows in images obtained with the transducer 1321.

[0133] FIG. 14 shows an example introducer 1435 that has a tip 1436, a waist 1437, and a body 1438. The waist 1437 is positioned between the tip 1436 and the body 1438. The waist 1437 may be positioned adjacent to an imaging transducer when the introducer 1435 is deployed. The waist 1437 may have a smaller cross-sectional area than the tip 1436 and / or the body 1438 which may advantageously reduce the likelihood of the shadow effect at least because the smaller profde of waist 1437 may block a smaller portion of the transducer relative to if the cross-sectional area of the waist 1437 equaled the cross-sectional area of the body 1438. The waist 1437 may be between 0.25in and 2in. between 0.5in and 1.5in, between 0.75in and 1.25, or about 0.75in. In some implementations, waist 1437 and / or body 1438 may be hollow which can advantageously reduce shadow effect. In some implementations, waist 1437 and / or body 1438 may have a meshed body which can advantageously reduce shadow effect. In some implementations, the waist 1437 may have a same cross-sectional area as the body 1438.

[0134] Introducers can have holes positioned along the introducer adjacent to the tip. Holes in an introducer can reduce how much an introducer occludes an imaging transducer which can advantageously reduce shadow effect. Hole size can vary depending on the implementation to reduce occlusion (e g., with larger holes). Space between holes can also vary depending on the implementation to reduce shadow effect. Accordingly, introducer 1435 and / or introducer tip 1436 and / or any of the other introducers and / or introducer tipsAttomey Docket No. :SUR.0129 WO can include holes of one or more sizes that can be arranged on the introducer at various spacings to reduce occlusion and shadow effect.

[0135] Relevant to the computational processing involving dynamic image processing, dynamically updating various image settings may improve imaging by accounting for various changing conditions, such as introducer penetration depth or changing shadows. Dynamically updating image settings based on various conditions can enhance image quality or features of interest (e.g., borders and edges of structures in the image) and / or maintain proper resolution. Adjusting image settings can include updating one or more of focal point, gain, filters, apodization, transmission pressure, angled plane wave mode, pulse inversion, and / or coated excitations. The computing device can dynamically update image settings at the beginning of a procedure and / or repeatedly during a procedure, as a function of the current activity (e.g., stage of the ablation procedure) or location of imaging interest, such as proximal, mid field, and distal areas of the myometrium).

[0136] Relevant to computational process involving tissue impedance tracking, tissue impedance can be measured with the electrodes and / or introducer. Different tissue types may have different impedances. Accordingly, various tissue types can be distinguished prior to ablation based on measuring their impedance values. A computing device can automatically identify ablation target areas based on impedance values measured with the electrodes and / or introducer to facilitate ablating the correct tissue regions and to avoid ablating incorrect tissue regions. Moreover, tissue impedance can change when the tissue is ablated. Accordingly, the computing device can monitor tissue impedance before, during, and after ablation to monitor the ablation progress. In some implementations, the computing device can automatically measure tissue impedance at predefined intervals and / or can measure tissue impedance in response to a user request or other condition. In some implementations, the computing device can automatically determine treatment progress from the tissue impedance and can provide indicia of the treatment progress to a user. In some implementations, the computing device can indicate to a user when to terminate ablation based on tissue impedance. In some implementations, the computing device can provide impedance measurements to a user for the user to determine treatment progress and / or when to terminate an ablation procedure.

[0137] Relevant to the computational processing involving passive cavitation detection, acoustic cavitation is the process of bubbles forming and / or collapsing in a medium when the medium is exposed to energy'. Ablating tissue can heat the tissue which can causeAttorney Docket No. :SUR.0129 WO acoustic cavitation at the treatment site. An acoustic sensor, such as a microphone or hydrophone, can convert acoustic energy' into electrical signals responsive to detecting acoustic cavitation, said electrical signals being indicative of the cavitation that is occurring. A computing device can access the electrical signals originating from the acoustic sensor and can process said signals to determine characteristics of the acoustic cavitation (e.g., rate of bubble formation, location of bubble formation, etc.). As discussed, bubbles may form at or near tissue that is being ablated, and in some cases, bubbles may form along the boundary of where tissue is being ablated (but not beyond the ablation site). Accordingly, bubbles can indicate ablation location which can improve detecting and monitoring treatment efficacy. Moreover, ablating tissue with more energy can result in more heat and more bubbles than ablating tissue with less energy7. Accordingly, bubbles can indicate the rate at which tissue is being ablated. In some implementations, a computing device can automatically modulate the energy delivered during ablation (e.g.. in real-time) based on acoustic cavitation detection to modify the rate at which tissue is ablated. For example, a computing device can determine that bubbles are forming rapidly and in response can decrease the energy7provided from an energy source to decrease the rate of ablation, or can similarly increase the rate of ablation by increasing the energy provided responsive to determining that bubbles are forming slowly. Modulating energy can include modulating one or more of energy output duration, power output (e.g., the rate at which energy is output including RF frequency and / or amplitude), or other parameter. Advantageously, acoustic cavitation detection can be implemented with or without imaging (e.g., ultrasound) and can thus provide an indication of ablation in addition to or in place of imaging. Acoustic cavitation detection may also be referred to as passive cavitation detection at least because imaging is not required to view processes that are occurring.

[0138] In some aspects, bubbles can be suppressed by high pressure pulses. In some aspects, bubbles can be used as therapeutic beacons to emulsify tissue (accelerate treatment). In some aspects, bubbles can be controlled by ultrasound if passively detected. Bubbles can be endogenous (created by RF energy') or exogenous (contrast agents injected through needles).

[0139] Certain categories of persons, such as caregivers, clinicians, doctors, and nurses, may be used interchangeably to describe a person providing care to a patient. Furthermore, patients or users used herein interchangeably refer to a person who is receiving treatment and / or being imaged.Attomey Docket No. :SUR.0129 WO

[0140] Although certain implementations and examples have been described herein, it will be understood by those skilled in the art that many aspects of the systems and devices shown and described in the present disclosure may be differently combined and / or modified to form still further implementations or acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. A wide variety of designs and approaches are possible. No feature, structure, or step disclosed herein is essential or indispensable. The various features and processes described herein may be used independently of one another, or may be combined in various ways. For example, elements may be added to, removed from, or rearranged compared to the disclosed example implementations. All possible combinations and sub-combinations are intended to fall w ithin the scope of this disclosure.

[0141] Any methods and processes described herein are not limited to any particular sequence, and the blocks or states relating thereto can be performed in other sequences that are appropriate. For example, described blocks or states may be performed in an order other than that specifically disclosed, or multiple blocks or states may be combined in a single block or state, or certain method or process blocks may be omitted, or certain blocks or states may be performed in a reverse order from what is shown and / or described. The example blocks or states may be performed in serial, in parallel, or in some other manner. Blocks or states may be added to or removed from the disclosed example implementations.

[0142] The methods disclosed herein may include certain actions taken by a practitioner; however, they can also include any third-party instruction of those actions, either expressly or by implication.

[0143] The methods and tasks described herein may be performed and fully automated by a computer system. The computer system may, in some cases, include multiple distinct computers or computing devices (e.g., physical servers, workstations, storage arrays, cloud computing resources, etc.) that communicate and interoperate over a network to perform the described functions. Each such computing device typically includes a processor (or multiple processors) that executes program instructions or modules stored in a memory or other non-transitory computer-readable storage medium or device (e.g., solid state storage devices, disk drives, etc.). The various functions disclosed herein may be embodied in such program instructions, and / or may be implemented in application-specific circuitry (e.g., ASICs or FPGAs) of the computer system. Where the computer system includes multiple computing devices, these devices may, but need not, be co-located. The results of theAttomey Docket No. :SUR.0129 WO disclosed methods and tasks may be persistently stored by transforming physical storage devices, such as solid state memory' chips and / or magnetic disks, into a different state. The computer system may be a cloud-based computing system whose processing resources are shared by multiple distinct entities or other users. The systems and modules may also be transmitted as generated data signals (for example, as part of a carrier wave or other analog or digital propagated signal) on a variety of computer-readable transmission mediums, including wireless-based and wired / cable-based mediums, and may take a variety of forms (for example, as part of a single or multiplexed analog signal, or as multiple discrete digital packets or frames).

[0144] Many other variations than those described herein will be apparent from this disclosure. For example, depending on the implementation, certain acts, events, or functions of any of the algorithms described herein can be performed in a different sequence, can be added, merged, or left out altogether (for example, not all described acts or events are necessary for the practice of the algorithms). Moreover, in certain implementations, acts or events can be performed concurrently, for example, through multithreaded processing, interrupt processing, or multiple processors or processor cores or on other parallel architectures, rather than sequentially. In addition, different tasks or processes can be performed by different machines and / or computing systems that can function together.

[0145] Various illustrative logical blocks, modules, routines, and algorithm steps that may be described in connection with the disclosure herein can be implemented as electronic hardware (e.g., ASICs or FPGA devices), computer software that runs on computer hardware, or combinations of both. Various illustrative components, blocks, and steps may be described herein generally in terms of their functionality. Whether such functionality is implemented as specialized hardware versus software running on general-purpose hardware depends upon the particular application and design constraints imposed on the overall system. The described functionality can be implemented in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the disclosure.

[0146] Moreover, various illustrative logical blocks and modules that may be described in connection with the implementations disclosed herein can be implemented or performed by a machine, such as a general purpose processor, a digital signal processor (’‘DSP”), an application specific integrated circuit (“ASIC”), a field programmable gate array (“FPGA”)Attorney Docket No. :SUR.0129 WO or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A general purpose processor can be a microprocessor, controller, microcontroller, or state machine, combinations of the same, or the like. A processor can include electrical circuitry configured to process computer-executable instructions. A processor can include an FPGA or other programmable devices that performs logic operations without processing computer-executable instructions. A processor can also be implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration. Although described herein primarily with respect to digital technology , a processor may also include primarily analog components. For example, some, or all, of the signal processing algorithms described herein may be implemented in analog circuitry or mixed analog and digital circuitry. A computing environment can include any type of computer system, including, but not limited to, a computer system based on a microprocessor, a mainframe computer, a digital signal processor, a portable computing device, a device controller, or a computational engine within an appliance, to name a few.

[0147] The elements of any method, process, routine, or algorithm described in connection with the disclosure herein can be embodied directly in hardware, in a software module executed by a processor, or in a combination of the two. A software module can reside in RAM memory, flash memory’, ROM memory, EPROM memory’, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM. or any other form of a non-transitory computer-readable storage medium. An exemplary storage medium can be coupled to the processor such that the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium can be integral to the processor. The storage medium can be volatile or nonvolatile. The processor and the storage medium can reside in an ASIC. The ASIC can reside in a user terminal. In the alternative, the processor and the storage medium can reside as discrete components in a user terminal.

[0148] Conditional language used herein, such as, among others, “can,"’ “could,’' “might,” “may,” “e.g..” and the like, unless specifically stated otherwise, or otherwise understood within the context as used, is generally intended to convey that certain features, elements, and / or steps are optional. Thus, such conditional language is not generally intended to imply that features, elements, and / or steps are in any way required or that one or moreAttorney Docket No. :SUR.0129 WO embodiments necessarily include logic for deciding, with or without other input or prompting, whether these features, elements, and / or steps are included or are to be always performed. The terms “comprising,"’ “including,’" “having,"’ and the like are synonymous and are used inclusively, in an open-ended fashion, and do not exclude additional elements, features, acts, operations, and so forth. Also, the term "‘or” is used in its inclusive sense (and not in its exclusive sense) so that when used, for example, to connect a list of elements, the term “or’" means one, some, or all of the elements in the list. Further, the term "each," as used herein, in addition to having its ordinary meaning, can mean any subset of a set of elements to which the term "each" is applied.

[0149] Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherw ise, is otherwise understood with the context as used in general to convey that an item, term, etc. may be either X, Y, or Z. Thus, such conjunctive language is not generally intended to imply that certain embodiments require the presence of at least one of X, at least one of Y, and at least one of Z.

[0150] Language of degree used herein, such as the terms “approximately,” “about,” “generally,” and “substantially” as used herein represent a value, amount, or characteristic close to the stated value, amount, or characteristic that still performs a desired function or achieves a desired result. For example, the terms “approximately”, “about”, “generally,” and “substantially” may refer to an amount that is within less than 10% of, within less than 5% of, within less than 1% of, within less than 0.1% of, and within less than 0.01% of the stated amount. As another example, in certain embodiments, the terms “generally parallel” and “substantially parallel” refer to a value, amount, or characteristic that departs from exactly parallel by less than or equal to 10 degrees, 5 degrees, 3 degrees, or 1 degree. As another example, in certain embodiments, the terms “generally perpendicular” and “substantially perpendicular’ refer to a value, amount, or characteristic that departs from exactly perpendicular by less than or equal to 10 degrees, 5 degrees. 3 degrees, or 1 degree.

[0151] As used herein, "‘real-time” or “substantial real-time” may refer to events (e.g., receiving, processing, transmitting, displaying etc.) that occur at a same time as each other, during a same time as each other, or overlap in time with each other. “Real-time” may refer to events that occur at distinct or non-overlapping times the difference between which is imperceptible and / or inconsequential to humans such as delays arising from electrical conduction or transmission. A human may perceive real-time events as occurring simultaneously, regardless of w hether the real-time events occur at an exact same time. AsAttomey Docket No. :SUR.0129 WO a non-limiting example, '‘real-time” may refer to events that occur within a time frame of each other that is on the order of milliseconds, seconds, tens of seconds, or minutes. For example, “real-time” may refer to events that occur within a time frame of less than 1 minute, less than 30 seconds, less than 10 seconds, less than 1 second, less than 0.05 seconds, less than 0.01 seconds, less than 0.005 seconds, less than 0.001 seconds, etc.

[0152] Unless otherwise explicitly stated, articles such as “a” or “an” should generally be interpreted to include one or more described items. Accordingly, phrases such as “a device configured to” are intended to include one or more recited devices. Such one or more recited devices can also be collectively configured to carry out the stated recitations. For example, “a processor configured to carry out recitations A, B and C” can include a first processor configured to cany7out recitation A working in conjunction with a second processor configured to carry out recitations B and C.

[0153] As used herein, “system,” “instrument.” “apparatus.” and “device” generally encompass both the hardware (for example, mechanical and electronic) and, in some implementations, associated software (for example, specialized computer programs for operational control) components.

[0154] It should be emphasized that many variations and modifications may be made to the herein-described implementations, the elements of which are to be understood as being among other acceptable examples. All such modifications and variations are intended to be included herein within the scope of this disclosure. Any section headings used herein are merely provided to enhance readability and are not intended to limit the scope of the implementations disclosed in a particular section to the features or elements disclosed in that section. The foregoing description details certain implementations. It will be appreciated, however, that no matter how detailed the foregoing appears in text, the systems and methods can be practiced in many ways. As is also stated herein, it should be noted that the use of particular terminology when describing certain features or aspects of the systems and methods should not be taken to imply that the terminology is being re-defined herein to be restricted to including any specific characteristics of the features or aspects of the systems and methods with which that terminology is associated.

[0155] Those of skill in the art would understand that information, messages, and signals may be represented using any of a variety of different technologies and techniques. For example, data, instructions, commands, information, signals, bits, symbols, and chips that may be referenced throughout the above description may be represented by voltages,Attomey Docket No. :SUR.0129 WO currents, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof.

[0156] While the above detailed description has shown, described, and pointed out novel features, it can be understood that various omissions, substitutions, and changes in the form and details of the devices or algorithms illustrated can be made without departing from the spirit of the disclosure. As can be recognized, certain portions of the description herein can be embodied within a form that does not provide all of the features and benefits set forth herein, as some features can be used or practiced separately from others. The scope of certain embodiments disclosed herein is indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.NUMBERED EMBODIMENTS OF THE INVENTION

[0157] 1. A computing system for performing a tumor ablation procedure, comprising: one or more processors configured to:obtain image data originating from an imaging device useable to generate ultrasound images;monitor changes in tissue morphology during treatment with one or more ultrasound-based imaging techniques to determine whether tissue has been treated, the tissue morphology comprising at least tissue stiffness; andgenerate user interface data for rendering a user interface comprising an ultrasound image corresponding to the image data, the user interface comprising indicia of whether the tissue has been treated.

[0158] 2. The computing system of embodiment 1, wherein the one or more processors are configured to:identify healthy tissue and tumorous tissue from the tissue morphology; and generate the user interface data to render the user interface with indicia of the healthy tissue and the tumorous tissue.

[0159] 3. The computing system of either of embodiments 1-2, wherein the one or more ultrasound-based imaging techniques comprise elastography, acoustic thermometry, and / or speckle tracking.Attorney Docket No. :SUR.0129 WO

[0160] 4. The computing system of any of embodiments 1 -3, wherein the one or more processors are configured to determine how long the tissue has been treated from the changes in the tissue morphology.

[0161] 5. The computing system of any of embodiments 1-4, wherein the one or more processors are configured to determine whether treatment is complete from the changes in the tissue morphology.

[0162] 6. The computing system of any of embodiments 1-5, wherein the one or more processors are configured to indicate via the user interface whether to continue treatment or terminate treatment.

[0163] 7. The computing system of any of embodiments 1-6, wherein the user interface includes indicia of treatment duration or treatment progress based on the changes in the tissue morphology.

[0164] 8. The computing system of any of embodiments 1-7, wherein the indicia of whether the tissue has been treated includes color variations corresponding to the changes in the tissue morphology.

[0165] 9. The computing system of any of embodiments 1-8, wherein the indicia of whether the tissue has been treated indicates whether intrauterine fibroids have been treated.

[0166] 10. The computing system of any of embodiments 1-9, wherein the imaging device is useable to deliver RF energy' to ablate intrauterine fibroids.

[0167] 11. A system for imaging uterine tissue, comprising:an imaging device comprising:an elongate probe;an ultrasound transducer disposed on a distal end of the elongate probe for generating image data of the uterine tissue; andan image generator comprising the computing system of any of embodiments 1-11 connected to the imaging device.

[0168] 12. A computing system for imaging a uterus for fibroid treatment, comprising: one or more processors configured to:obtain imaging data originating from an imaging device within a uterine cavity of a patient;determine a position of a serosa from the image data; andAttomey Docket No. :SUR.0129 WO generate user interface data for rendering a user interface comprising a serosa tracker superimposed on an ultrasound image, the serosa tracker corresponding to the position of the serosa.

[0169] 13. The computing system of embodiment 12, wherein the image data originates from the imaging device during a calibration transducer scan before deploying an active electrode for ablation.

[0170] 14. The computing system of embodiment 13, wherein the one or more processors are configured to display the serosa tracker when a portion of the serosa is occluded from view within the ultrasound image due to a shadow effect after deploying the active electrode.

[0171] 15. The computing system of either of embodiments 13-14, wherein the one or more processors are configured to determine the position of the serosa with a machine learning model trained to identify serosas with a preexisting image dataset.

[0172] 16. The computing system of any of embodiments 13-15, wherein the image data corresponds to a plurality of poses in which the imaging device is oriented during the calibration transducer scan.

[0173] 17. The computing system of embodiment 16, wherein the one or more processors are configured to:determine boundaries based on user input via the imaging device, the boundaries including a treatment boundary and a safety7boundary7;update the user interface with indicia of the boundaries;obtain a plurality of safety rotation images comprising a plurality of planes of view during a safety rotation transducer scan after the active electrode is deployed; and automatically determine whether the boundaries are safely positioned relative to the serosa tracker in the plurality of planes of view from the plurality of safety rotation images.

[0174] 18. The computing system of either of embodiments 16-17, wherein the one or more processors are configured to enhance a portion of the serosa obscured by a shadow effect in the ultrasound image based on constructing the portion of the serosa from a plurality of images obtained at different poses during the safety rotation transducer scan.

[0175] 19. The computing system of any of embodiments 16-18, wherein the one or more processors are configured to construct the portion of the serosa with a 3D imaging technique.Attomey Docket No. :SUR.0129 WO

[0176] 20. The computing system of any of embodiments 16-19, wherein the plurality of poses includes a first angular position of the imaging device and a second angular position of the imaging device, the first angular position being orthogonal to the second angular position about an axis.

[0177] 21. A system for imaging uterine tissue, comprising:an imaging device comprising:an elongate probe;an ultrasound transducer disposed on a distal end of the elongate probe for generating image data of the uterine tissue; andan active electrode deployable from the elongate probe;an image generator comprising the computing system of any of embodiments 12-20 connected to the imaging device.

[0178] 22. A system for imaging uterine tissue, comprising:an imaging device comprising:an elongate probe; andan ultrasound transducer disposed on a distal end of the elongate probe for generating image data of the uterine tissue; andan image generator comprising the computing system of any of embodiments 12-20 connected to the imaging device.

[0179] 23. A computing system for imaging a uterus for fibroid treatment, comprising: one or more processors configured to:obtain imaging data originating from an imaging device within a uterine cavity of a patient;generating user interface data for rendering a user interface with an ultrasound image from the image data, wherein the ultrasound image includes a serosa representation; andconstructing a portion of the serosa representation obscured by a shadow effect caused by a portion of the imaging device in the ultrasound image.

[0180] 24. The computing system of embodiment 23, wherein theimage data originates from the imaging device within the uterine cavity of the patient during a safety rotation transducer scan wherein the image data corresponds to a plurality of poses in which the imaging device is oriented during the safety rotation transducer scan, wherein the portion of the serosa representation obscured by theshadowAttorney Docket No. :SUR.0129 WO effect in the ultrasound image is constructed from the image data obtained at the plurality of poses during the safety rotation transducer scan.

[0181] 25. The computing sy stem of embodiment 24, wherein the one or more processors are configured to construct the portion of the serosa representation with a 3D imaging technique.

[0182] 26. The computing system of either of embodiments 23-24, wherein the one or more processors are configured to obtain the image data from the imaging device within the uterine cavity of the patient while an active electrode is deployed from the imaging device, wherein the portion of the imaging device that causes the shadow effect in the ultrasound image comprises the deployed active electrode.

[0183] 27. A system for imaging uterine tissue, comprising:an imaging device comprising:an elongate probe;an ultrasound transducer disposed on a distal end of the elongate probe for generating image data of the uterine tissue; andan active electrode deployable from the elongate probe;an image generator comprising the computing system of embodiment 23 connected to the imaging device.

[0184] 28. The system of embodiment 27, wherein the active electrode comprises an introducer.

[0185] 29. An imaging and treatment device, comprising:an elongate probe;a transducer carried by the elongate probe configured to image tissue; and an introducer configured to extend from the elongate probe along a longitudinal introducer axis adjacent to the transducer into the tissue, wherein the longitudinal introducer axis is offset from a transducer plane extending longitudinally along a midline of the transducer.

[0186] 30. The imaging and treatment device of embodiment 29, wherein the longitudinal introducer axis intersects the transducer plane at an angle.

[0187] 31. The imaging and treatment device of embodiment 30, wherein the angle is between 1° and 10°.Attorney Docket No. :SUR.0129 WO

[0188] 32. The imaging and treatment device of any of embodiments 29-31, wherein the longitudinal introducer axis is parallel with the transducer plane, wherein the longitudinal introducer axis is separated from the transducer plane by a distance.

[0189] 33. The imaging and treatment device of embodiment 32, wherein the distance is between 0.5mm and 2mm.

[0190] 34. The imaging and treatment device of any of embodiments 29-33, wherein the transducer is an ultrasound transducer.

[0191] 35. The imaging and treatment device of any of embodiments 29-34, wherein the tissue is uterine tissue.

[0192] 36. An imaging and treatment device, comprising:an elongate probe;a transducer carried by the elongate probe configured to image tissue; and an introducer deploy able from the elongate probe along a longitudinal introducer axis adjacent to the transducer into the tissue, such that introducer causes a shadow effect in the image of the tissue, wherein the introducer has a tip, a body, and a waist positioned between the tip and the body, wherein the waist has a smaller cross-sectional area than the tip and the body, such that the shadow effect in the image of the tissue is reduced.37. The imaging and treatment device of embodiment 36, wherein the introducer is hollow, thereby reducing the shadow effect in the image of the tissue.

[0193] 37. The imaging and treatment device of embodiment 36, wherein the introducer is meshed, thereby reducing the shadow effect in the image of the tissue.

[0194] 38. A computing system for imaging a uterus, comprising:one or more processors configured to:obtain image data originating from a transducer of an imaging device, wherein the image data is useable to generate an ultrasound image;dynamically update one or more image settings while the transducer is generating the image data based on a depth at which an introducer is deployed to enhance a visual contrast between one or more features of interest and adjacent tissue in the ultrasound image; andgenerate user interface data for rendering a user interface comprising the ultrasound image corresponding to the image data with the one or more image settings.Attorney Docket No. :SUR.0129 WO

[0195] 39. The computing system of embodiment 38, wherein dynamically updating one or more image settings includes updating one or more of a focal point, a gain, a fdter, apodization, or a transmission pressure.

[0196] 40. The computing system of either of embodiments 38-39, wherein the one or more features of interest includes a serosa, a fibroid, or an endometrial lining.

[0197] 41. The computing system of any of embodiments 38-40, wherein the one or more processors are configured to dynamically update one or more image settings repeatedly during an ablation procedure.

[0198] 42. A computing system for performing a tissue ablation procedure, comprising:one or more processors configured to:access electrical signals originating from an acoustic sensor responsive to detecting acoustic cavitation at a treatment site;determine an ablation location from the electrical signals;determine an ablation rate from the electrical signals; andmodulate an energy' output from an energy' source to an ablation device to modify the ablation rate.

[0199] 43. The computing system of embodiment 42, wherein modulating the energy output includes modulating a power output or modulating a duration of energy output.

Claims

Attomey Docket No. :SUR.0129 WO WHAT IS CLAIMED IS:

1. A computing system for imaging a uterus for fibroid treatment, comprising: one or more processors configured to:obtain imaging data originating from an imaging device within a uterine cavity of a patient;determine a position of a serosa from the image data; andgenerate user interface data for rendering a user interface comprising a serosa tracker superimposed on an ultrasound image, the serosa tracker corresponding to the position of the serosa.

2. The computing system of claim 1, wherein the image data originates from the imaging device during a calibration transducer scan before deploying an active electrode for ablation.

3. The computing system of claim 2. wherein the one or more processors are configured to display the serosa tracker when a portion of the serosa is occluded from view within the ultrasound image due to a shadow effect after deploying the active electrode.

4. The computing system of either of claims 2-3, wherein the one or more processors are configured to determine the position of the serosa with a machine learning model trained to identify serosas with a preexisting image dataset.

5. The computing system of any of claims 2-4, wherein the image data corresponds to a plurality of poses in which the imaging device is oriented during the calibration transducer scan.

6. The computing system of claim 5, wherein the one or more processors are configured to:determine boundaries based on user input via the imaging device, the boundaries including a treatment boundary and a safety boundary;update the user interface with indicia of the boundaries;obtain a plurality of safety rotation images comprising a plurality of planes of view during a safety rotation transducer scan after the active electrode is deployed; and automatically determine whether the boundaries are safely positioned relative to the serosa tracker in the plurality of planes of view from the plurality of safety rotation images.Attomey Docket No. :SUR.0129 WO 7. The computing system of either of claims 5-6, wherein the one or more processors are configured to enhance a portion of the serosa obscured by a shadow effect in the ultrasound image based on constructing the portion of the serosa from a plurality of images obtained at different poses during the safety rotation transducer scan.

8. The computing system of any of claims 5-7, wherein the one or more processors are configured to construct the portion of the serosa with a 3D imaging technique.

9. The computing system of any of claims 5-8, wherein the plurality of poses includes a first angular position of the imaging device and a second angular position of the imaging device, the first angular position being orthogonal to the second angular position about an axis.

10. A system for imaging uterine tissue, comprising:an imaging device comprising:an elongate probe;an ultrasound transducer disposed on a distal end of the elongate probe for generating image data of the uterine tissue; andan active electrode deployable from the elongate probe;an image generator comprising the computing system of any of claims 1-9 connected to the imaging device.

11. A system for imaging uterine tissue, comprising:an imaging device comprising:an elongate probe; andan ultrasound transducer disposed on a distal end of the elongate probe for generating image data of the uterine tissue; andan image generator comprising the computing system of any of claims 1-9 connected to the imaging device.

Images