System for imaging tissue

Abstract

Disclosed herein is a computing system connectable to an imaging device having an elongate probe, an imaging transducer for generating image data of tissue and one or more inertial sensors configured to generate inertial data indicating an orientation of the elongate probe. The computing system comprises one or more processors configured to access the inertial data and generate user interface data for rendering a user interface comprising indicia of the orientation of the elongate probe. The processor(s) may be further configured to display an image of the tissue in accordance with the image data and an orientation graphic on a display screen in accordance with the orientation data. The orientation graphic may include a graphical annulus, at least one reference marker located on the graphical annulus, and a graphical direction indicator within the graphical annulus, indicating an orientation of the imaging transducer relative to the at least one reference marker.

Description

Attomey Docket No. :SUR.0127 WO SYSTEM AND METHOD FOR IMAGING TISSUETECHNICAL FIELD[OOOlJThe present disclosure relates to tissue imaging and ablation systems and methods, particularly for use in the treatment of uterine fibroids.

[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 with 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 cartying 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 well as U.S. Pat. Nos. 7,815,571. 7,874,986, 7,918.795, 8,506,485, 8.992,427, 9,357,977,Attomey Docket No. :SUR.0127 WO 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 typically 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 proximity7to 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 new7devices are introduced or if devices are upgraded with new7sensor electronics, expensive software upgrades must be made in order to make the imaging console compatible with the new sensor electronics.SUMMARY

[0006] In accordance with a first aspect of the present inventions, a computing system connectable to an imaging device having an elongate probe, an imaging transducer (e.g., an ultrasound transducer) disposed on a distal end of the elongate probe for generating image data (e.g., ultrasound data) of tissue and one or more inertial sensors configured to generate inertial data indicating an orientation of the elongate probe. The computing system comprises one or more processors configured to access the inertial data generated by theAttomey Docket No. :SUR.0127 WO one or more inertial sensors, and generate user interface data for rendering a user interface comprising indicia of the orientation of the elongate probe.

[0007] In one embodiment, an orientation graphic indicating the orientation of the elongate probe. Such orientation graphic may include a graphical representation of the elongate probe and a graphical annulus (e.g., a graphical circle) in which the graphical representation of the elongate probe is disposed. A longitudinal axis of the graphical representation of the elongate probe may extend through the center of the graphical annulus. In this embodiment, the graphical representation of the elongate probe may optionally be configured to rotate about the longitudinal axis based on the inertial data to provide a real-time visualization of a roll of the elongate probe. In another embodiment, the orientation graphic may include at least one reference marker disposed on the graphical annulus. The reference marker(s) may comprise an orientation marker, e g., corresponding to a position on a clockface or comprising one of a Left, Posterior, Right, and Anterior marker. If the imaging transducer is an ultrasound transducer, the orientation graphic may optionally include a graphical representation of ultrasound waves or arcs originating from the ultrasound transducer.

[0008] In still another embodiment, the imaging device is an imaging and treatment device that further comprises a tissue ablation electrode carried by the elongate probe. In this case, the user interface may comprise a treatment map indicating an ablation location relative to the elongate probe. The processor(s) may be is configured to determine the ablation location from the inertial data. In this embodiment, the orientation graphic may include a graphical representation of the elongate probe and a graphical annulus in which the graphical representation of the elongate probe is disposed. In this case, the treatment map may comprise one or more ablation markers disposed on the graphical annulus. In this embodiment, the user interface may further comprise ablation information including one or more of an ablation event, an ablation size, an ablation volume, and an ablation duration.

[0009] In accordance with a second aspect of the present inventions, a system for imaging uterine tissue is provided. The system may comprise an imaging device comprising an elongate probe, an imaging transducer disposed on a distal end of the elongate probe for generating image data of tissue, and one or more inertial sensors configured to generate inertial data indicating an orientation of the elongate probe, the computing system. The system further comprises an image generator comprising the computing system connected to the imaging device. In one embodiment, the system may further comprise a cable set removably connectible with the handle and configured to connect the imaging transducerAttorney Docket No. :SUR.0127 WO to an image generator. The inertial sensor(s) may be positioned in the cable set and at least one of the processors may be positioned in the cable set. In another embodiment, the inertial sensor(s) may be positioned in the handle.

[0010] In accordance with a third aspect of the present inventions, an image generator connectable to a device having an elongate probe, an imaging transducer (e.g., an ultrasound transducer) disposed on a distal end of the elongate probe for generating image data (e.g., ultrasound data) of tissue and at least one sensor mechanically associated with the elongate probe for generating orientation data indicative of an orientation of the imaging transducer, is provided. The image generator comprises at least one processor configured to display an image (e.g., an ultrasound image) of the tissue in accordance with the image data and an orientation graphic on a display screen in accordance with the orientation data. The orientation graphic includes a graphical annulus, at least one reference marker located on the graphical annulus (e.g.. a circle), and a graphical direction indicator within the graphical annulus, indicating an orientation of the imaging transducer relative to the reference marker(s).

[0011] In one embodiment, the processor(s) is configured for simultaneously displaying the image of the tissue and the orientation graphic on the display screen. In another embodiment, the graphical direction indicator originates at a center of the graphical annulus. In another embodiment, the reference marker(s) may comprise an orientation marker (e.g., corresponding to a position on a clockface or corresponding to Left, Posterior, Right, and Anterior). In another embodiment, the further has a tissue ablation electrode, in which case, the reference marker(s) may comprise an ablation marker. If the imaging transducer is an ultrasound transducer, the orientation graphic may optionally include a graphical representation of ultrasound waves or arcs originating from the ultrasound transducer. In still another embodiment, the orientation data is further indicative of an orientation of the elongate probe, in which case, the orientation graphic may further include a graphical representation of the elongate probe that is oriented relative to the at least one reference marker. The imaging transducer may be articulatable relative to the elongate probe, in which case, the orientation data may indicate a current articulation angle of the imaging transducer, and the graphical orientation indicator may be oriented relative to the graphical representation of the elongate probe in accordance with the current articulation angle of the imaging transducer.Attorney Docket No. :SUR.0127 WO

[0012] In accordance with a fourth aspect of the present inventions, a system for imaging tissue comprises an imaging device comprising an elongate probe, an imaging transducer disposed on a distal end of the elongate probe for generating image data of tissue, and at least one sensor mechanically associated with the elongate probe for generating orientation data indicative of an orientation of the imaging transducer. The system further comprises the image generator connected to the imaging device.

[0013] 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).Attomey Docket No. :SUR.0127 WO BRIEF DESCRIPTION OF THE DRAWINGS

[0014] 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.

[0015] FIG. 1 A shows an imaging and treatment system for imaging and / or treating uterine fibroids.

[0016] FIG. IB shows another example implementation of an imaging and treatment system.

[0017] FIG. 2A shows an example implementation of a cable that is connectible with an imaging and treatment device.

[0018] FIG. 2B is a cutaway side view of a handle connector of a cable.

[0019] FIG. 2C is a cutaway bottom view of an ultrasound generator connector.

[0020] FIG. 2D is a schematic diagram of an imaging and treatment device with a cable.

[0021] FIG. 3A is a top perspective of an imaging and treatment device.

[0022] FIG. 3B is a bottom perspective view of the proximal end of the imaging and treatment device.

[0023] FIG. 3C is an exploded side view of the imaging and treatment device.

[0024] FIGS. 3D-3E are exploded top view of the imaging and treatment device.

[0025] FIG. 3F is a top perspective of an alternative imaging and treatment device.

[0026] FIG. 4 is a cutaway side view of the imaging and treatment device.

[0027] FIG. 5A is a cutaway side view of a transducer and elongate probe of the imaging and treatment device.

[0028] FIGS. 5B-5D illustrate various articulation angles of the transducer.

[0029] FIG. 6A illustrates an imaging and treatment component inside a uterus.

[0030] FIG. 6B shows an image that can be visible on a display during imaging and treatment.

[0031] 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.

[0032] FIG. 7 illustrates an example user interface providing a visualization of the orientation of the imaging and treatment device.

[0033] FIGS. 8A-8B show an imaging and treatment device within a uterus with fibroids.Attorney Docket No. :SUR.0127 WO

[0034] FIGS. 9A-9B illustrate an example user interface showing fibroid treatment within a uterus.

[0035] FIG. 10 is a flowchart illustrating an example process of generating 3D images of tissue.DETAILED DESCRIPTION

[0036] 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.

[0037] 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 as 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.Attomey Docket No. :SUR.0127 WO

[0038] FIG. 1 A 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.

[0039] 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.

[0040] 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 imaging and treatment system 100 comprises one dispersive electrode or two or more dispersive electrodes.

[0041] 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.

[0042] 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),Attomey Docket No. :SUR.0127 WO 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.

[0043] The energy cable 113 can conduct energy, such as RF energy, from the energy source 105 to the imaging and treatment device 101.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] The handle connector 201 can removably connect with a handle of an imaging and treatment device (for example, with handle 1 17 of imaging and treatment device 101 shown and / or described in FIG. IB). The electrical connector 202 can electrically couple with 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 show n and / or described in FIGS. 1 A-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.Attorney Docket No. :SUR.0127 WO

[0048] 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 energy7source 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.

[0049] 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.

[0050] FIG. 2B is a cutaway side view of the handle connector 201 show n and / or described in FIG. 2 A. The handle connector 201 includes an interconnect printed circuit board (PCB) 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.Attorney Docket No. :SUR.0127 WO

[0051] 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.

[0052] 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.

[0053] 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 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.

[0054] FIG. 2C is a cutaway bottom view of the ultrasound generator connector 205 shown and / or described in FIG. 2 A. 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 processorAttorney Docket No. :SUR.0127 WO 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.

[0055] 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 known positions of the introducer, electrode tines, and / or transducer to generate calibration data. Known positions can be generated from separate 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 itselfAttomey Docket No. :SUR.0127 WO 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.

[0056] Any of the electronic components of the ultrasound generator connector 205, such as the PCB 217 and / or the hardw are 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.

[0057] 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 atransducer 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 energy and can also conduct data encoded in electrical signals. Energy 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 quality’ 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 preserve ultrasound image quality'. For example, shielding and / orAttomey Docket No. :SUR.0127 WO grounding can reduce noise and / or minimize crosstalk (e.g., electrical and / or acoustic) between transducer lines 232 and energy transmission lines 234.

[0058] 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 forw arding it to the ultrasound generator 237. If new7imaging 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 betw een 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.

[0059] 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 which can presen- e quality of transducer quality 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.

[0060] 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 groundsAttorney Docket No. :SUR.0127 WO 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.

[0061] FIG. 3 A 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.

[0062] 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. 1 A). 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., rotate) to different angles relative to the elongate probe 319. For example, as shown 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 ofAttomey Docket No. :SUR.0127 WO articulation (e g., more than 0°) can be used to more easily view target tissue within the uterus (e.g., a uterine fibroid).

[0063] 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 energy7source (e.g., energy7source 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).

[0064] 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.

[0065] 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 the 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) oneAttorney Docket No. :SUR.0127 WO 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 a tooth 418 of the 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.

[0066] 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 cur ed 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 321 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 andAttorney Docket No. :SUR.0127 WO 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.

[0067] FIGS. 3A, 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 tow ards 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 which 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.

[0068] 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 on 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. ForAttorney Docket No. :SUR.0127 WO 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.

[0069] 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 between 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 is 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 nominalAttomey Docket No. :SUR.0127 WO 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.

[0070] 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.

[0071] 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 the reusable cable 200 shown in FIG. 2A. FIG. 3B also show-s the first slider 312 and the second slider 314 of the handle 317, further disclosed above.

[0072] 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 ofthehandle317. 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 showsAttorney Docket No. :SUR.0127 WO the exposed printed circuit board 360, while FIG. 3E does not. Like FIG. 3 A, 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.

[0073] 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 precision 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).Attomey Docket No. :SUR.0127 WO

[0074] 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.

[0075] A plurality of carriage sensors 318a, 318b are shown 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 carnage 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).

[0076] 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 carriage 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 carnage sensors 318c, 318d, 318e are positioned such that at least one of the sensors can measure its distance from the second carriage magnet 315. By 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).Attorney Docket No. :SUR.0127 WO

[0077] 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.

[0078] 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).

[0079] 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.

[0080] 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 memory devices that store data, including without limitation, 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 dnves, 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. ForAttorney Docket No. :SUR.0127 WO 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).

[0081] 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.

[0082] The imaging and treatment device 301 can include additional and / or alternative lockout mechanism for preventing the imaging and treatment device 301 from being reused 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, theAttorney Docket No. :SUR.0127 WO handle 317 can include a one-way connector that can connect to reusable cable but that destroys the one-way connector upon disconnection.

[0083] 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).

[0084] 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°.

[0085] 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.

[0086] 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 inAttorney Docket No. :SUR.0127 WO the third notch 420c can correspond to a third articulation angle, such as 60°, show n in FIG.5D. It will be understood that there can be more or fewer than three notches. It will also be understood that the angles of articulation associated with each notch can be tuned by the manufacturer.

[0087] 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.

[0088] 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.

[0089] 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.

[0090] 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 wall SW. The imaging component 600 can be 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.

[0091] 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), inAttomey Docket No. :SUR.0127 WO 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.

[0092] 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.

[0093] 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.

[0094] 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 700 can show the graphical device representation 703 as rotating about the longitudinal axis 709.

[0095] 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 thisAttorney Docket No. :SUR.0127 WO example, the orientation markers 711 A-71 IB 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 711 A-71 IB 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.

[0096] 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.

[0097] 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.

[0098] 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 interface 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 inertialAttomey Docket No. :SUR.0127 WO sensor 213). Accordingly, user interface 700 can provide a real-time visualization of the orientation of the imaging and treatment device during a procedure.

[0099] 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 711 A). 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).

[0100] 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, user interface 900 A, 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.

[0101] User interface 900A includes an orientation graphic 903 positioned adjacent to the ultrasound image 901. The orientation graphic 903 can include similar structural and / orAttorney Docket No. :SUR.0127 WO 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.

[0102] 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 successful 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, the 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.Attorney Docket No. :SUR.0127 WO

[0103] FIG. 10 is a flowchart illustrating an example process 1000 for generating 3D images with an ultrasound. This process, in full or parts, can be executed by one or more hardware processors, whether they are associated with a singular computing device / system or multiple computing devices / systems, and even devices in remote or wireless communication. By way of example, the one or more hardware processors executing process 1000 can be associated with imaging and treatment device, cable, ultrasound generator, and / or any of the computing devices shown and / or described herein. For example, hardware processor 366 in the imaging and treatment device, hardware processors 214, 219 in the cable, and / or hardware processor 123 of the ultrasound generator 107 can execute process 1000, or any portions thereof, alone or in combination. The implementations of this process may vary and can involve modifications like omitting blocks, adding blocks, and / or rearranging the order of execution of the blocks. Process 1000 serves as an example and is not intended to restrict the present disclosure. In some implementations, process 1000, or any portions thereof, can be performed during an ablation procedure when RF energy is being provided to an imaging and treatment device. For example, a computing device can perform at least block 1011 to generate and / or display a 3D image based on image data originating from an imaging and treatment device when RF energy is being provided to the imaging and treatment device for ablation.

[0104] At block 1001, a computing device (e.g., one or more hardware processors of a computing device executing program instructions) can access inertial information originating from one or more inertial sensors positioned on or relative to an imaging device (which in some aspects may be an imaging and treatment device). The inertial sensors can be positioned in a cable removably connected with the imaging and treatment device and / or may be positioned within the imaging and treatment device itself (e.g., within a handle of the device). The inertial sensors can include one or more of an accelerometer, gy roscope, and / or inclinometer. In some implementations, the inertial sensors can include inertial sensor 213 shown and / or described herein. The inertial information can indicate a pose of the imaging and treatment device, or components thereof such as elongate probe and / or transducer, within a uterus. As used herein, the term “pose’' can relate to movement of the imaging and treatment device, or components thereof, within six degrees of freedom comprising rotation around three axes and translation along the three axes, the three axes being orthogonal. As such, the term “pose” can refer to linear position of the imaging and treatment device along the three axes (e.g., X, Y, Z coordinates) and / or rotational positionAttomey Docket No. :SUR.0127 WO of the imaging and treatment device about the three axes (e.g., roll, pitch, yaw angles). In some aspects, “pose” and “orientation” may be used interchangeably.

[0105] At block 1003 the computing device can determine one or more reference points for calibrating the inertial information. For example, a reference point can be useable to calibrate movement of the imaging and treatment device along three orthogonal axes to determine the position of the imaging and treatment device, or any components thereof such as an elongate probe and / or imaging transducer. A reference point can correspond to a physiological structure such as a cervix, an internal os, an external os. or a fundus of a uterus. A reference point can include inertial information indicating a fixed linear position. For example, a reference point can include X, Y, Z coordinates. In some implementations, the computing device can determine a plurality of reference points corresponding to a plurality of fixed linear positions. For example, one reference point may correspond to a cervical os and another reference point may correspond to a uterus fundus. Advantageously, a plurality of reference points may increase the accuracy with which a 3D image can be generated.

[0106] The computing device can determine a reference point responsive to user input. For example, a user can provide input via an actuator on. or associated with, an imaging and treatment device, such as actuator 308 shown and / or described herein. Responsive to the user input, the computing device can record the inertial information that was generated at the time the user provided the input. As an example, as the user transcervically inserts the imaging and treatment device into the uterus, the user may feel resistance as the transducer (tip of the device) enters the cervix, or the user may feel a decrease in resistance as the transducer exits the cervix and enters the uterus, or the user may feel resistance as the transducer presses against the uterus fundus. The user can provide input to record one or more reference points based on feeling a change in resistance.

[0107] In some implementations, the imaging and treatment device can automatically detect and / or generate reference points (e.g., without user input). For example, an electronic pad can be positioned external to a patient such as under the patient as they lie on their back for imaging and / or treatment. The pad may be attached to the patient, for example by¬ adhesion. straps, etc., such that the pad is fixed and immovable relative to the patient. As the imaging and treatment device passes adjacent to the pad (the device being within the patient and the pad being external to the patient), the imaging and treatment device can communicate with the pad to determine its position relative to the pad. For example, theAttomey Docket No. :SUR.0127 WO imaging and treatment device can detect when it has passed over certain points on the pad which may be positioned relative to regions of interest in the patient such as the cervix, fundus, etc. The imaging and treatment device can generate reference point(s) as it detects that it has passed over certain points on the pad.

[0108] At block 1005, the computing device can determine a pose of a transducer of the imaging and treatment device from the inertial information and / or the reference point. The pose of the transducer (e.g., within a uterus) can be relative to the reference point. The pose can include linear position and / or angular position of the transducer. For example, the computing device can determine that the transducer has moved 4 cm past the reference point (e.g., cervical os) and is thus positioned at a depth of 4 cm within the uterus. The computing device can also determine that the imaging and treatment device is rotated 45 degrees about its longitudinal axis (e.g., roll angle) and is inclined 20 degrees (e.g., pitch angle). The lengths and angles provided in this example are illustrative purposes and are not intended to limit the scope of this disclosure.

[0109] At block 1007, the computing device can access articulation information originating from an articulation sensor positioned in and / or associated with the imaging and treatment device. The articulation sensor can include a contact sensor (such as a resistive sensor) or a non-contact sensor (such as a hall-effect sensor). In some implementations, the articulation sensor may be the sensor 325 shown and / or described herein. The articulation information can indicate an articulation angle of the transducer. The transducer articulation angle (and transducer pose) will determine the direction in which ultrasound waves propagate away from the transducer, which in turn determines where the transducer is imaging (e.g., which portion of the uterus is being imaged).

[0110] At block 1009, the computing device can correlate image signals generated by the transducer with transducer pose and articulation angle. For example, the computing device can associate image signals with the transducer pose and articulation angle that existed at the time the image signals were generated. Advantageously, because image signals are associated with transducer pose and articulation angle that occurred at the time of imaging, the portion of tissue imaged by those image signals can be determined. The computing device can also derive the pose of the treatment element (in this case, the needle 630 of FIG. 5A) from the from the inertial information and / or the reference point in a similar manner described above with respect to the transducer, and based on this derived pose, andAttomey Docket No. :SUR.0127 WO correlate ablation locations (e.g., the locations of the ablation markers 905 illustrated in FIG. 9A) to the pose of the treatment element.[OHl] At block 1011, the computing device can combine image signals from the transducer to generate a 3D image by combining the image signals based on their associated articulation angles and transducer poses. For example, the computing device can stitch together a plurality of images to construct a 3D image of tissue (e.g., intrauterine tissue and / or adjacent physiological structures) because the relative positions of the images can be determined from the articulation angles and transducer poses that are associated with the images. The 3D image can be a volumetric image. The computing device can combine the image signals based on the inertial information. In some cases, the computing device can combine the image signals based on the reference point. In some implementations, the computing device can generate a 3D image without the reference point (e.g., agnostic to any reference point).

[0112] At block 1013, the computing device can optionally update the 3D image based on historical images of the patient before a procedure. Updating the 3D volumetric image can include one or more of enhancing, correcting, or augmenting the 3D image. The historical images can include one or more of historical ultrasound images, historical magnetic resonance (MR) images, or historical computed tomography (CT) images. The computing device can retrieve the historical images from a database. The computing device can identify physiological features of interest prior to the procedure from the historical images which may be indicated as such in the historical images and can then also identify corresponding features (e.g., physiological structures) in the 3D image such as by comparing the 3D image with the historical images (e.g., with on one or more image processing techniques). For example, the computing device can compare pixels of the 3D image with pixels of the historical images to determine which physiological features in the 3D image correspond to which physiological features in the historical image. The computing device can update the 3D image to indicate the physiological features of interest in the 3D image. For example, the computing device can cause the 3D image to be rendered with highlighted features of interest.

[0113] Disclosed herein is a computing system for creating an intrauterine 3D volumetric image of uterine tissue, comprising: one or more hardware processors configured to: access inertial information originating from one or more inertial sensors positioned on, or relative to, an imaging device; determine a reference point for calibrating the inertial information;Attorney Docket No. :SUR.0127 WO determine a pose of a transducer of the imaging device from the inertial information and the reference point, the pose including linear position and angular position of the transducer within a uterus relative to the reference point; correlate image signals generated by the transducer during an imaging process with the pose of the transducer occurring when the image signals were generated: and combine the image signals from the transducer to generate an intrauterine 3D volumetric image of the uterus based on combining the image signals according to the correlated pose of the transducer. In some implementations, the one or more hardware processors are configured to: access articulation information originating from an articulation sensor in the imaging device, the articulation information indicating an articulation angle of the transducer; correlate the image signals generated by the transducer during the imaging process with the articulation information occurring when the image signals were generated; combine the image signals from the transducer to generate the intrauterine 3D volumetric image of the uterus based on combining the image signals according to the correlated articulation information. In some implementations, the pose of the transducer relates to movement or position of the transducer within six degrees of freedom comprising rotation around three axes and translation along the three axes, the three axes being orthogonal. In some implementations, the reference point is useable to calibrate movement of the imaging device along three orthogonal axes to determine position of the transducer. In some implementations, the reference point corresponds to a physiological structure including one or more of a cervix, an internal os, an external os, or a fundus. In some implementations, the reference point comprises a fixed linear position including X, Y, and Z coordinates. In some implementations, the one or more hardware processors are configured to determine a plurality of reference points for calibrating the inertial information each corresponding to a unique physiological structure having unique positions. In some implementations, the one or more hardware processors are configured to determine the reference point responsive to user input. In some implementations, the intrauterine 3D volumetric image includes images of physiological structures adjacent to the uterus. In some implementations, the one or more hardware processors are configured to update the intrauterine 3D volumetric image based on historical images of a patient before a procedure, the historical images comprising one or more of historical ultrasound images, historical magnetic resonance (MR) images, or historical computed tomography (CT) images. In some implementations, the one or more hardware processors are configured to: retrieve the historical images from a database; identify physiological featuresAttomey Docket No. :SUR.0127 WO of interest prior to the procedure from the historical images; and update the intrauterine 3D volumetric image to indicate the physiological features of interest. In some implementations, updating the intrauterine 3D volumetric image includes one or more of enhancing, correcting, or augmenting the intrauterine 3D volumetric image. In some implementations, the imaging device includes one or more electrodes for ablating intrauterine fibroids, wherein the one or more hardware processors are configured to generate the intrauterine 3D volumetric image of the uterus when the one or more electrodes are ablating the intrauterine fibroids.

[0114] 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.

[0115] 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 within the scope of this disclosure.

[0116] 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.Attomey Docket No. :SUR.0127 WO

[0117] The methods disclosed herein may include certain actions taken by a practitioner; however, they can also include any third-party7instruction of those actions, either expressly or by implication.

[0118] 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 the disclosed methods and tasks may be persistently stored by transforming physical storage devices, such as solid state memory7chips 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 variety7of 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).

[0119] 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.Attomey Docket No. :SUR.0127 WO

[0120] 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.

[0121] 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”) 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.

[0122] 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 moduleAttorney Docket No. :SUR.0127 WO 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 memory7, 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.

[0123] 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 more 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.

[0124] Conjunctive language such as the phrase “at least one of X, Y, and Z,” unless specifically stated otherwise, 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.

[0125] 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 thanAttorney Docket No. :SUR.0127 WO 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.

[0126] 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 whether the real-time events occur at an exact same time. As 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.

[0127] 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 cany out the stated recitations. For example, “a processor configured to cany' out recitations A, B and C” can include a first processor configured to carry out recitation A working in conjunction with a second processor configured to carry out recitations B and C.

[0128] 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.

[0129] 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 beAttorney Docket No. :SUR.0127 WO 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.

[0130] 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, currents, electromagnetic waves, magnetic fields or particles, optical fields or particles, or any combination thereof.

[0131] 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

[0132] 1. A computing system connectable to an imaging device having an elongate probe, an imaging transducer disposed on a distal end of the elongate probe for generating image data of tissue and one or more inertial sensors configured to generate inertial data indicating an orientation of the elongate probe, the computing system, comprising:one or more processors configured to:access the inertial data generated by the one or more inertial sensors; andAttomey Docket No. :SUR.0127 WO generate user interface data for rendering a user interface comprising indicia of the orientation of the elongate probe.

[0133] 2. The computing system of embodiment 1, wherein the indicia of the orientation of the elongate probe comprises an orientation graphic indicating the orientation of the elongate probe.

[0134] 3. The computing system of embodiment 2, wherein the orientation graphic includes a graphical representation of the elongate probe and a graphical annulus in which the graphical representation of the elongate probe is disposed.

[0135] 4. The computing system of embodiment 3, wherein a longitudinal axis of the graphical representation of the elongate probe extends through the center of the graphical annulus.

[0136] 5. The computing system of embodiment 4, wherein the graphical representation of the elongate probe is configured to rotate about the longitudinal axis based on the inertial data to provide a real-time visualization of a roll of the elongate probe.

[0137] 6. The computing system of any of embodiments 3-5, wherein the orientation graphic includes at least one reference marker disposed on the graphical annulus.

[0138] 7. The computing system of embodiment 6, wherein the graphical annulus is a circle.

[0139] 8. The computing system of embodiment 6, wherein each of the at least one reference marker comprises an orientation marker.

[0140] 9. The computing system of embodiment 8, wherein the orientation marker corresponds to a position on a clockface.

[0141] 10. The computing system of embodiment 8, wherein the orientation marker is one of a Left, Posterior, Right, and Anterior marker.

[0142] 11. The computing system of any of embodiments 2-10, wherein the imaging transducer is an ultrasound transducer, the image data is ultrasound data, and the image of the tissue is an ultrasound image, and wherein the orientation graphic further includes a graphical representation of ultrasound waves or arcs originating from the ultrasound transducer.

[0143] 12. The computing system of any of embodiments 2-11, wherein the imaging device is an imaging and treatment device further compnsing a tissue ablation electrode carried by the elongate probe, and wherein the user interface comprises a treatment mapAttomey Docket No. :SUR.0127 WO indicating an ablation location relative to the elongate probe, wherein the one or more processors is configured to determine the ablation location from the inertial data.

[0144] 13. The computing system of embodiment 12, wherein the orientation graphic includes a graphical representation of the elongate probe and a graphical annulus in which the graphical representation of the elongate probe is disposed, wherein the treatment map comprises one or more ablation markers disposed on the graphical annulus.

[0145] 14. The computing system of either of embodiments 12-13, wherein the user interface further comprises ablation information including one or more of ablation event, ablation size, ablation volume, and ablation duration.

[0146] 15. A system for imaging tissue, comprising:an imaging device comprising:an elongate probe;an imaging transducer disposed on a distal end of the elongate probe for generating image data of tissue; andone or more inertial sensors configured to generate inertial data indicating an orientation of the elongate probe, the computing system; andthe image generator of any of embodiments 1-14 connected to the imaging device.

[0147] 16. The system of embodiment 15, further comprising a cable set removably connectible with the handle and configured to connect the imaging transducer to an image generator, wherein .the one or more inertial sensors are positioned in the cable set.

[0148] 17. The system of embodiment 16. wherein at least one of the processors are positioned in the cable set.

[0149] 18. The system of any of embodiments 15-17, wherein the one or more inertial sensors are positioned in the handle.

[0150] 19. An image generator connectable to an imaging device having an elongate probe, an imaging transducer disposed on a distal end of the elongate probe for generating image data of tissue and at least one sensor mechanically associated with the elongate probe for generating orientation data indicative of an orientation of the imaging transducer, the image generator comprising:at least one processor configured to display an image of the tissue in accordance with the image data and an orientation graphic on a display screen in accordance with the orientation data, the orientation graphic including a graphical annulus, at least oneAttorney Docket No. :SUR.0127 WO reference marker located on the graphical annulus, and a graphical direction indicator within the graphical annulus, indicating an orientation of the imaging transducer relative to the at least one reference marker.

[0151] 20. The image generator of embodiment 19, wherein the at least one processor is configured for simultaneously displaying the image of the tissue and the orientation graphic on the display screen.

[0152] 21. The image generator of either of embodiments 19-20, wherein the graphical direction indicator originates at a center of the graphical annulus.

[0153] 22. The image generator of any of embodiments 19-21, wherein the graphical annulus is a circle.

[0154] 23. The image generator of any of embodiments 19-22, wherein the at least one reference marker comprises a plurality of reference markers.

[0155] 24. The image generator of any of embodiments 19-23, wherein each of the at least one reference marker comprises an orientation marker.

[0156] 25. The image generator of embodiment 24, wherein the orientation marker corresponds to a position on a clockface.

[0157] 26. The image generator of embodiment 24, wherein the orientation marker is one of a Left, Posterior, Right, and Anterior marker.

[0158] 27. The image generator of any of embodiments 19-26, wherein imaging device further has a tissue ablation electrode, and wherein each of the at least one reference marker comprises an ablation marker.

[0159] 28. The image generator of any of embodiments 19-27, wherein the imaging transducer is an ultrasound transducer, the image data is ultrasound data, and the image of the tissue is an ultrasound image.

[0160] 29. The image generator of embodiment 28, wherein the orientation graphic further includes a graphical representation of ultrasound waves or arcs originating from the ultrasound transducer.

[0161] 30. The image generator of any of embodiments 19-29, wherein the orientation data is further indicative of an orientation of the elongate probe, and wherein the orientation graphic further includes a graphical representation of the elongate probe that is oriented relative to the at least one reference marker.

[0162] 31. The image generator of embodiment 30, wherein the imaging transducer is articulatable relative to the elongate probe, wherein the orientation data indicates aAttorney Docket No. :SUR.0127 WO current articulation angle of the imaging transducer, and wherein the graphical orientation indicator is oriented relative to the graphical representation of the elongate probe in accordance with the current articulation angle of the imaging transducer.

[0163] 32. A system for imaging uterine tissue, comprising:an imaging device comprising:an elongate probe;an imaging transducer disposed on a distal end of the elongate probe for generating image data of the uterine tissue; andat least one sensor mechanically associated with the elongate probe for generating orientation data indicative of an orientation of the imaging transducer; andthe image generator of any of embodiments 19-31 connected to the imaging device.

Claims

Attomey Docket No. :SUR.0127 WO WHAT IS CLAIMED IS:

1. A computing system connectable to an imaging device having an elongate probe, an imaging transducer disposed on a distal end of the elongate probe for generating image data of tissue and one or more inertial sensors configured to generate inertial data indicating an orientation of the elongate probe, the computing system, comprising:one or more processors configured to:access the inertial data generated by the one or more inertial sensors; and generate user interface data for rendering a user interface comprising indicia of the orientation of the elongate probe.

2. The computing system of claim 1, wherein the indicia of the orientation of the elongate probe comprises an orientation graphic indicating the orientation of the elongate probe.

3. The computing system of claim 2. wherein the orientation graphic includes a graphical representation of the elongate probe and a graphical annulus in which the graphical representation of the elongate probe is disposed.

4. The computing system of claim 3, wherein a longitudinal axis of the graphical representation of the elongate probe extends through the center of the graphical annulus.

5. The computing system of claim 4, wherein the graphical representation of the elongate probe is configured to rotate about the longitudinal axis based on the inertial data to provide a real-time visualization of a roll of the elongate probe.

6. The computing system of any of claims 3-5, wherein the orientation graphic includes at least one reference marker disposed on the graphical annulus.

7. The computing system of any of claims 3-6, wherein the graphical annulus is a circle.

8. The computing system of claim 6, wherein each of the at least one reference marker comprises an orientation marker.

9. The computing system of claim 8, wherein the orientation marker corresponds to a position on a clockface.

10. The computing system of claim 8, wherein the orientation marker is one of a Left, Posterior, Right, and Anterior marker.

11. The computing system of any of claims 2-10, wherein the imaging transducer is an ultrasound transducer, the image data is ultrasound data, and the image of the tissueAttorney Docket No. :SUR.0127 WO is an ultrasound image, and wherein the orientation graphic further includes a graphical representation of ultrasound waves or arcs originating from the ultrasound transducer.

12. The computing system of any of claims 2-11, wherein the imaging device is an imaging and treatment device further comprising a tissue ablation electrode carried by the elongate probe, and wherein the user interface comprises a treatment map indicating an ablation location relative to the elongate probe, wherein the one or more processors is configured to determine the ablation location from the inertial data.

13. The computing system of claim 12, wherein the orientation graphic includes a graphical representation of the elongate probe and a graphical annulus in which the graphical representation of the elongate probe is disposed, wherein the treatment map comprises one or more ablation markers disposed on the graphical annulus.

14. The computing system of either of claims 12-13, wherein the user interface further comprises ablation information including one or more of an ablation event, an ablation size, an ablation volume, and an ablation duration.

15. A system for imaging tissue, comprising:an imaging device comprising:an elongate probe;an imaging transducer disposed on a distal end of the elongate probe for generating image data of tissue; andone or more inertial sensors configured to generate inertial data indicating an orientation of the elongate probe, the computing system; andthe image generator of any of claims 1-14 connected to the imaging device.

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