Systems and methods for enhanced ultrasound imaging

Abstract

Systems and methods for imaging, such as with an intravascular ultrasound (IVUS) imaging device are employed with components and accessories, such as for example, catheters, a catheter interface module, mounts, a workstation, a tablet, a display, and cart. The components may be controlled or interacted with via hands-free commands, voice control, gestures, and may be enhanced with artificial intelligence and / or machine learning. Real time measurements and border detection with enhanced imaging are provided.

Description

EVID.027WO PATENT SYSTEMS AND METHODS FOR ENHANCED ULTRASOUND IMAGING REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Application No. 63 / 546,058 filed October 27, 2023 titled “Systems and Methods For Intravascular Ultrasound” which is hereby incorporated by reference in its entirety, herein. BACKGROUND Field

[0002] The present disclosure relates to the field of imaging vessels and other target tissue, using, for example, ultrasound. Intravascular ultrasound (IVUS), as well as ultrasound visualization outside a vessel, are provided in several embodiments. Imaging is used to facilitate intervention in several embodiments. Description of the Related Art

[0003] Ultrasound imaging systems, including those used for intravascular imaging, emit and receive acoustic waves in order to produce an image based off reflections from objects near the ultrasound transducer, such as tissue. IVUS catheter systems can be used to capture ultrasound images. SUMMARY

[0004] Several embodiments of medical imaging systems, such as IVUS systems are provided herein. Advantageously, according to several embodiments, such systems include one or more features that, for example, enhance imaging, image guided therapy, measurements, usability, ease of setup, streamlining of workflow, reduced operating times, improved clinical efficacy, accuracy of therapeutic intervention delivery, guiding interventional therapy, synergies with peripheral interventions, informing treatment decisions, optimizing the user experience throughout the clinical workflow including setup, imaging, measurements and reporting, and diagnosis accuracy among others. In some embodiments, IVUS is a diagnostic image-guided therapy-tool for the treatment of both peripheral arterial and venous disease, enabling 2D and / or 3D intraluminal visualization. In some embodiments, IVUS (or other imaging devices) are provided in combination with components and accessories such as a catheter, a catheter interface module, a workstation, a tablet, a display, a cart, and one or more mounts. In several embodiments, a mount can be a universal mount, an articulating mount, or a tablet mount with a microphone to enable voice control capabilities. In various embodiments, streamlining of workflow and ease of setup and use is enhanced via hands-free commands, voice control, and / or gestures are be used to interact with the imaging systems (e.g., IVUS system) in some embodiments. Artificial intelligence and / or machine learning (AI / ML) are employed in some embodiments to enable image interpretation (e.g., based on real-time detection, classification, and / or measurements of image features such that the processing of images occurs more quicklyand such that an amount of image information is increased, more accurate, or provided with increased confidence and / or displayed with enhanced confidence indicators), streamline workflows, increase ease of setup, increase processing efficiency, broaden IVUS adoption, analyze images, identify vascular irregularities, conduct measurements, support diagnoses, predict outcomes or provide treatment recommendations, facilitate intervention and / or confirm progress of or success of a treatment. In several embodiments, irregularities may be identified across an image series and displayed graphically as an overlay on the timeline or schematic representation of the patient’s anatomy. In several embodiments, a system includes a wireless touch screen tablet that also provides for hands-free tasks such as responding to user voice commands for AI assisted measurements and real time border detection with an IVUS imaging catheter. In one embodiment, the system is matched for high definition (e.g., HD, UHD, HD+, etc.) image quality using acoustics and signal processing customized for peripheral vascular imaging with superior resolution and optimal penetration. Several embodiments are configured for intravascular imaging with a platform that is optimized for peripheral vascular procedures that will enable improved image interpretation, intervention guidance, and enhance ease of use and improve overall usability to streamline intraprocedural and clinical workflow. In several embodiments, the system improves usability with a contemporary system featuring a simplified user-interface and enhanced total-system capabilities leveraging AI to streamline workflow and image interpretation.

[0005] For example, image interpretation and measurement of luminal geometry (e.g., diameter, stenosis, peripheral interventions, coronary interventions, atherectomy, lithotripsy, intravascular lithotripsy (IVL), balloon placement, stent placement, venous procedures, below the knee (BTK) procedures, AV Fistula, robotic and robot-controlled diagnosis and treatment devices, tools, and procedures (e.g., for precision guided robotic and / or automatic instruments for repair with small incisions in minimally invasive robotic procedures, such as robotic vascular, endovascular, cardiac and / or peripheral procedures, vessel bypass surgery, vasculature repair, robotic assisted laparoscopic surgery, implant / stent / ballon / filter placement and / or removal, etc.) and other procedures are performed with embodiments described herein. In some embodiments, imaging as described herein is used to identify and / or guide the placement of an occluder in a peripheral vessel or in coronary (or other) tissue. Procedures can be performed by interventional cardiologists, radiologists, and / or vascular surgeons in hospitals, physician offices, Office Based Labs (OBL), and / or Ambulatory Surgery Centers (ASC). In several embodiments, systems described herein can be used efficiently in the hospital and OBL / ASC without specialized clinical support. In addition, several embodiments use imaging as described herein to confirm whether a particular intervention has been successfully performed immediately after such intervention has been performed or within 12-72 hours thereafter. Such confirmation may also be used several days, weeks or months later as a way to confirm that the intervention has been accomplished as desired. In some embodiments, imaging as described herein is used to confirm whether a particular intervention is being performed according to protocol in real time. For example, the imaging may be done simultaneously with (e.g., during), before and / or after the intervention. Anintervention may include therapy or other intervention such as peripheral interventions, coronary interventions, atherectomy, IVL, balloon placement, stent placement, venous procedures, BTK procedures, AV Fistula, and other procedures. Imaging can include, for example, IVUS non-coronary peripheral vessels, IVUS in coronary vessels, ultrasound, intraluminal imaging, imaging of body cavities and organs, and other imaging as described herein (and combinations thereof). In some embodiments, imaging as described herein is used to identify and / or guide the placement of an occluder in a peripheral vessel or in coronary (or other) tissue. In some embodiments, the cardiac imaging as described herein is used in intracardiac visualization (e.g., may be used instead of intracardiac echocardiography (ICE) procedures). The architectures, AI / ML technologies, edge detection, voice control, plug and play, and other aspects may be particularly useful for intracardiac imaging (and in one embodiment may be used to supplement or improve ICE techniques). In some embodiments, the dimensions of the catheter components described herein are adjusted in size for intracardiac delivery (e.g., in some cases larger than the dimensions for blood vessels).

[0006] Several embodiments described herein are particularly well-suited to address unmet needs in women's health. In cardiovascular disease, women are often undertreated as compared with men. Symptoms may also present differently in women. The enhanced imaging technologies described herein in several embodiments do not rely on symptom reporting by a patient or perception of a patient's symptoms, and thus at the very least can be viewed as gender neutral in many aspects. Underreporting by women and misdiagnosis when women do report symptoms are some key contributors to the undertreatment of women for cardiovascular disease. Advantageously, several innovative features described herein are beneficial for women because they are adapted to visualize and diagnose vascular and cardiac disease early and with greater precision in small vessels (as are found more often in women). Additionally, several embodiments described herein are useful for diagnosis of May- Thurner syndrome, a blood vessel condition that most often affects young women and can lead to deep vein thrombosis (DVT). Smaller vessel sizes in women generally (and younger women as an example) can pose difficulties in placement and positioning of stents (and other devices or interventional therapies), and several embodiments described herein are adapted to image smaller vessels and facilitate placement and positioning of stents and other devices (occluders, etc.), and facilitate or otherwise inform therapy (such as mechanical clot retrieval, aspiration, lithotripsy, angioplasty, bypass procedures, etc.). Using AI, machine learning and / or data analysis, additional embodiments described herein can be further used to correlate a woman's risk based on the enhanced images and can further suggest that a particular therapy may be more effective to treat such conditions (or suggest that the patient should be scheduled for follow up because she has an increased risk). Another unmet need in women’s healthcare is the need for more precise diagnosis in the treatment of fibroids and cysts, which can be accomplished in several embodiments described herein using enhanced visualization and detection of the boundaries of such fibroids and cysts (including those in the uterus, ovary and breast). This, in turn, should allow for more precise and complete removal (or other treatment) of the undesired tissue, while preserving healthytissue. The amount of the surgical margin removed or otherwise treated may also be reduced (as compared to not using the technologies described herein) because of the precision in visualization and / or boundary detection of the fibroid or cyst.

[0007] Many of these embodiments should be particularly advantageous to ensure that patients are not receiving unnecessary additional diagnostics or interventions, which in turn provides better patient care and reduces the short-term burden on the healthcare system. In several embodiments, use of a system and AI to determine patient eligibility for further intervention (e.g., further diagnostics or therapeutics) and additionally use of the system and AI to reduce risk that patient receives unnecessary further interventions. Advantages include better patient care and reduces the short-term burden on the healthcare system. Likewise, many of these embodiments help patients receive the needed additional diagnostics or interventions they need, which in turn provides better patient outcomes and reduces the long-term burden on the healthcare system (by treating patients earlier in the disease progression timeline). In several embodiments, an IVUS system provides a contemporary IVUS platform and catheter portfolio that provides improved usability with superior image interpretation and streamlined bedside workflow at a competitive cost enabling broader adoption. In several embodiments, systems described herein leverage the power of AI to enable superior image interpretation and streamlined workflows, increasing adoption, driving increased market penetration and enabling improved clinical outcomes with faster, more accurate diagnosis and treatment.

[0008] In some embodiments, the ultrasound imaging technologies described herein are used to visualize fluids, whether internal or externally delivered. Drug delivery, including for example via fluid or nano particle delivery, may also be visualized. Such visualization may be helpful for confirming delivery to the desired target region, saturation, etc. in a vessel or other lumen, to a tumor or other abnormality (such as thrombus, plaque, calcium, etc.). Visualization may be before, after and / or during delivery of a drug and real-time visualization is provided in several aspects. In one embodiment, ultrasound is also used to facilitate drug delivery.

[0009] In some embodiments, the ultrasound imaging technologies described herein are used to visualize neuromodulation, such as nerve ablation, blocks, and stimulation. Such visualization may be helpful for confirming delivery of the neuromodulation (e.g., by heat, cryotherapy, chemical, radiofrequency, microwave, acoustic, etc.) to the desired target nerve(s) in a vessel, other lumen or region. This is turn may be used to increase the likelihood that the target nerve is treated, while preserving healthy nerves and other healthy tissue surrounding the target nerve. Visualization may be before, after and / or during neuromodulation and real-time visualization is provided in several aspects.

[0010] Several embodiments are configured to identify the borders or edges of abnormalities such as tumors, lesions, plaque, thrombus, etc. Such abnormalities may be vascular and within a vessel or located outside a vessel. During surgery, ablation or other intervention, it can be difficult to tell where an abnormality ends and healthy tissue begin. Thus, unnecessary multiple procedures may be required, which can lead to pooreroutcomes such as increased cost and strain on the medical system, increased pain, and longer hospital stays. Many surgeries would be improved with better tissue visualization using the technology described herein. By determining the edge (e.g., border or boundaries) of tumors or other undesired target region, not only can healthy tissue be preserved but the likelihood is increased that complete removal or at least more of the undesired tissue / region is removed. Several embodiments allow medical professionals to clearly visualize tissue borders, blood vessels, nerves, lymph ducts, etc. in real time during surgery or other procedure, and additionally allow for post-procedure enhanced images. In some aspects, the imaging device can be placed in a vessel but is also able to visualize tissue (including abnormalities) outside the vessel. The enhanced images provided by various embodiments described herein (e.g., real time availability of enhanced images) allow precision surgical intervention that reduces the risk of error and additional corrective surgeries. Improved patient outcomes, including complete removal of cancerous tissue, lesions, plaque, etc. while preserving healthy tissue, is accomplished by the enhanced visualization described in several embodiments described herein. Further, visualization of vessels or tissues outside of vessels may be performed without dyes or radiation in many embodiments. Using AI, machine learning and / or data analysis, additional embodiments described herein can be further used to more accurately identify the distinction between healthy tissue and diseased tissue. Also, such tools may be able to predict whether a certain margin of tissue - which seems healthy at the time but is actually high risk to contain unhealthy cells for example - should be removed, which in turn reduces the likelihood that further surgeries are required. Tumors that can be visualized and optionally treated according to several embodiments herein include, for example, fibroids, polyps, abnormal cell clusters, etc. including but not limited to those located in reproductive organs such as the uterus, the nasal or ear cavity, rectum, colon, other intestinal regions or elsewhere. Cysts, cell growths, lumps, fluid-filled growths are examples of tissue abnormalities that can be visualized and optionally treated according to several embodiments. The ability to visualize the boundaries of such tumors, cysts and other growths allow for more precision excision, ablation or other treatment to (i) more completely remove the undesired tissue, (ii) remove only as much other tissue as is needed to prevent future re-occurrence (e.g., surgical margin), and / or (iii) preserve healthy tissue. In several embodiments, a system and method is provided herein to reduce the region of the surgical margin ablated, excised or otherwise treated by using the enhanced visualization technologies described herein.

[0011] As used herein, the terms edge, border and boundary are used interchangeably.

[0012] In several embodiments, two or more of the following features are provided in combination:

[0013] Artificial Intelligence: In several embodiments, the systems described herein, including for example the advanced intravascular ultrasound platform, leverage AI to enable image interpretation, enhance total-system capabilities, and streamline workflows to maximize the clinical value. In some embodiments, advantageously, physicians will not need to integrate imaging data spatially and temporally to fully interpret the clinical condition. Instead, systems according to several embodiments described herein can leverage the powerof AI with generational advancements to go beyond single image interpretation. The AI-powered engine, for example, enhances image interpretation with a simplified workflow improving overall useability. Machine learning is used in several embodiments. In one embodiment, the AI-ready processing power is designed to support real time and on-demand image interpretation (e.g., thereby increasing the speed and confidence in clinicians making decisions regarding diagnosis and / or treatment of tissue or a patient condition). The AI powered workstation can provide high end processing and an AI engine for advanced signal and image processing. In various embodiments, the native image data capture provides for superior image interpretation (e.g., border detection, identification and measurement of vessel size, vessel disease, dissection, plaque morphology, etc.). In several embodiments, the systems described herein provide simplified measurement via automated border detection (e.g., AI algorithms automatically identify borders of a lumen, vessel, tissue, lesion, plaque, implant, stent, balloon, etc.). In several embodiments, the system provides simplified measurement via semi-automated border detection (e.g., the user can manually adjust or modify automated AI algorithms that identify borders of a lumen, vessel, tissue, lesion, plaque, implant, stent, balloon, etc. with the border selection reconfigured based on user modifications). In one embodiment, AI plaque identification utilizes AI algorithms to automatically classify and identify types of plaque within the imaged area to provide user guidance on treatment options (e.g., using color coding, icons or text overlays can be used to indicate what type of condition, such as an irregularity such as plaque, may be present for the selected image). In several embodiments, the data driven platform is designed to collect data, simplify image interpretation, with AI processing power to support real time and on-demand image interpretation and increase ease of use and reduce user cognitive load to help (i) identify lumen size, (ii) visualize dissections, (iii) characterize disease morphology, (iv) locate and quantify stenosis, and / or (v) identify true lumen. In some embodiments, image interpretation is used to identify thrombus, plaque, calcium, tissue health, stent or balloon apposition, and / or stent or balloon “health” or condition. Image interpretation may involve imaging to evaluate quality and / or position of placement of existing stent. Image interpretation can involve identifying position relative to lumen walls, determine level of and / or quality of tissue grown into and around the stent or balloon. In one embodiment, for example with a bioresorbable stent, image interpretation can involve (i) evaluating the amount of dissolving of the stent, (ii) determining if the dissolving of the stent is in accordance with expected decay patterns (e.g., determining whether the level of decay on one side of the stent similar to the other side of the stent, and if not, that may indicate a problem with stent placement, or if the stent is dissolving more rapidly than expected that could indicate the stent will not provide the tissue with the expected structural support). In several embodiments, AI is used in real time and may or may not be used in conjunction with recording data and using artificial intelligence in retrospect. In several embodiments, AI may be used whether in real time or alone, whether in real time and based on recordings, and / or whether based on recordings alone to identify various characteristics, including but not limited to, the size of the lumen, the presence of calcium, the grade of calcium, obstructions, lesions,deformities, placement of stents, occluders and other devices, etc. In some embodiments, AI is used to aid the physician in making a diagnosis.

[0014] AI may be used in real time in conjunction with imaging. This has several advantages in some embodiments, for example, real-time AI can be employed for data collection, predictive outcomes and / or correlations. In one embodiment, AI is used for predictive outcomes, e.g., determining co-morbidity in a given percent of cases where hard plaque is identified in a particular artery, such as in the femoral artery. In several embodiments, real time AI is accomplished by measuring and providing feedback identifying tissue borders and / or edges. In some embodiments, imaging as described herein is used to identify and / or guide the placement of an occluder in a peripheral vessel or in coronary (or other) tissue.

[0015] In one embodiment, the system can measure thickness and circumference and grades of calcium, which can dictate therapy. In several embodiments, blood flow (e.g., speckle visualization) is visualized with the system allowing identification of thrombus existence and thrombus parameters. In one embodiment, blood dynamics and / or speckle visualization may be displayed in adjacent frames. In several embodiments, visualization of a vein is possible when the catheter is in an artery and / or visualization of an artery is possible when the catheter is in a vein. In several embodiments, visualization in collateral tissue and vessels is possible while the catheter is in a different vessel. In several embodiments, IVUS clarity of imaging visualization is comparable to an external ultrasound or computed tomography (CT).

[0016] Plug and Play Catheter: According to several embodiments, catheters optimized for vascular imaging are configured for superior pushability, tracking, and crossing for arterial and venous vasculature. In several embodiments, catheters have superior pushability to avoid kinking with sufficient column strength to advance the catheter through tortuous bends and occlusions in vasculature without buckling, over bending, or collapsing anywhere along the catheter (e.g., ability to cross an occlusion or constriction). In several embodiments, catheters have superior tracking for the ability of the catheter to follow a guidewire through tortuous bends in vasculature, having sufficient flexibility and strength to move along and advance along a guidewire to target locations within the vasculature. In several embodiments, catheters have superior crossing capabilities to cross occlusions, restrictions and constrictions within the vasculature, such as at sites with tissue blockage (e.g., stenoses, etc.) and / or implant blockages (such as stents, balloons, etc.). The systems described herein, such as an IVUS catheter, can include a rotational design that is plug and play and for example, can allow the catheter to be taken out of the sterile package and prepared for use without the need to flush the device. In one embodiment, the catheter has a single rotational ultrasound element. In several embodiments, the catheter includes an encapsulated coupling medium (e.g., coupling medium, medium, liquid, fluid, gel, etc.) that supports the spinning inner imaging core inside the catheter jackets. In one embodiment, the IVUS catheter is a plug and play catheter with a rotational IVUS design flush-less peripheral disposable imaging catheter with a full length of 280 cm with a working length of 150 cm compatible with a 0.014” guidewire and a 5F sheath, allowing the IVUS catheter proximalconnector to attach to the CIM outside of the sterile field. In one embodiment, the IVUS catheter is a plug and play catheter is a flush-less peripheral disposable imaging catheter with a full length of 250 cm with a working length of 110 cm compatible with a 0.035” guidewire and an 8F sheath, allowing the IVUS catheter proximal connector to attach to the CIM outside of the sterile field. Connecting outside of the sterile field optionally avoids having to drape a cabled motor unit inside of the sterile field. In several embodiments, the high definition (e.g., HD, ultra high definition (UHD), UHD, HD+, etc.) imaging uses acoustic pulse echoes with a matched excitation frequency spectrum for optimal penetration, ultra high resolution, and high definition image quality. In several embodiments, the system is optimized for peripheral vascular imaging, coronary imaging, or both. The imaging core spins inside the polymer jacket using an inner drive shaft connected through a proximal hub / connector in one embodiment. The hub connector is optionally attached to the CIM after removal from its sterile catheter package. The transducer located at the distal tip of the imaging core can rotate at between 1500 – 4000 rpm and receives echoes for processing into a circular image on the tablet display. The length of the catheter can be 8 to 10 feet long. In various embodiments the catheter can be taken out of the sterile package and prepared for use without the need to flush the device. The lengths can allow the catheter proximal connector to connect to the CIM outside of the sterile field. Connecting outside of the sterile field avoids having to drape a cabled motor unit inside of the sterile field in one embodiment. The catheter can include non-volatile memory that includes unique catheter identification, usage data, and calibration for optimal imaging performance. Calibration may include data related to measurements of electrical impedance versus frequency, acoustic sensitivity versus frequency, and / or beam profile data that is specific to the individual device according to some embodiments. In some embodiments, high definition imaging is enabled via acoustics and signal processing customized for peripheral vascular imaging, with superior resolution and optimal penetration.

[0017] Catheter Interface Module: A CIM is a hardware interface between the system cable from the workstation and disposable catheters according to several embodiments. In several embodiments, the CIM provides the system (e.g., IVUS system) with a rotational drive and ultrasound signal processing functions. Custom electronics may control the motor that rotates the imaging core inside the catheter. The electronics may also transmit and receive ultrasound signals between the spinning transducer within the distal end of the catheter tip and the custom Ultrasound System Control (USC) board inside the workstation. In various embodiments, the CIM provides an interface to read and write non-volatile memory in, for example, the catheter. Memory can be used to calibrate an ultrasound transducer for each unique catheter. In one embodiment, catheter memory may be used to select the appropriate system configuration to achieve the best possible imaging performance. The CIM may transmit ultrasound signals, sensor data, and / or catheter information from a catheter to a workstation and / or at least one tablet, which may store the transmitted information in a non-volatile memory in one or more locations. As discussed herein, a tablet and workstation may be interchangeable in function and / or features. In one embodiment, the CIM is mounted on a bed rail outside a sterile field. The CIM mounting interface to the bedrailmay be a clamp actuated by a lever / handle. In one embodiment the lever (e.g., with the clamp when in the open position) may serve as a handle for conveniently and safely moving the CIM from a storage location to the mounting position. The handle allows for single handed operation to mount and actuate the clamp to the bedrail.

[0018] Tablet: A tablet comprising a hand-held wireless touchscreen computer used as the user interface for the IVUS system that can be docked onto a tablet mount is provided according to one embodiment. The tablet includes, for example, computational hardware unit for the tablet software. One, two, three or more tablets may be connected to the system (e.g., IVUS system). Having a wireless interface can simplify the setup by avoiding extra cabling in the catheter lab. Supporting multiple tablets allows for multiple points of interaction simultaneously and for flexibility in tablet positioning in several embodiments. In several embodiments, one or more tablets may be used as an interface for a workstation.

[0019] User Interface: In several embodiments, the tablet provides the user interface with an image centric approach for image controls buttons, simplified case browsing, timeline interaction, implicit recording vs explicit recording, labeling, compound measurements, procedure summary report are provided according to one embodiment. The modern user interface can be configured to address user needs for simple and intuitive interaction, with customized screen layouts creating persistent user-customizable screen layouts that allow users to adjust parameters such as color scheme and control positions (e.g., ability to optimize the display elements to support left or right-handed physicians). In some embodiments, color themes may be user selectable to support (i) color blindness, (ii) environmental preferences for optimizing readability, (iii) color theme with company / clinician office branded colors, (iv) mono-chromatic color themes, (v) high-contrast color themes, (vi) user modified color scheme. In several embodiments, intraluminal measurements use imaging to capture images to diagnose, measure, and plan for treatment of a variety of diseases and conditions. In several embodiments, systems described herein are used to capture images to diagnose, measure, and plan for treatment of a variety of cardiovascular diseases and conditions. In some embodiments the user interface includes a display for one or more images or videos with one or more controls (e.g., buttons, slides, touch controls, etc.) for display, recording, taking snapshot / still image, video looping, linear measurement, area measurement, volume measurement, contrast control, brightness control, zooming capability, recording audio, sound, voice, memos, display of timelines, placement of bookmarks, display of data, notation writing device, virtual keyboard, trash / deletion, microphone, speaker, volume control, multiple display (of 1, 2, 3, 4, or more images or videos) with measurement capability. In several embodiments, compound measurements include one or more of the following: (i) computation of cross-frame and cross-recording metrics such as blockage to provide guidance to clinician and procedure reporting, (ii) computation of metrics within a single image or across multiple images acquired during a procedure, (iii) measurements may include percent stenosis, ratios of maximum to minimum diameters, ratios of maximum to average diameters, ratios of minimum to average diameters, and (iv) customized compound measurement types based on selected procedure type or user preferences. In several embodiments, variable recoding playback speedmay be included with the system. In one embodiment, the user can adjust playback speed and imaging window of a recording (e.g., “pullback”) to improve visual interpretation. In various embodiments, a reference to “pullback” movement of the catheter may refer to retracting the catheter in a proximal direction and also contemplate advancing the catheter within the vessel in a distal direction. Longitudinal movement comprises pullback or pulling back a catheter from a vessel or other lumen, pushing or otherwise advancing a catheter into a vessel or other lumen, or both.

[0020] Imaging Screen: In several embodiments, the tablet includes an imaging screen, which for example can project images to a separate display. In several embodiments, the workstation includes an imaging screen, which for example can project images to a separate display. In several embodiments, a simplified imaging screen is image centric having one or more of the following: (i) the image (e.g., an IVUS image) as most prominent with UI elements minimized to product a visually simple screen, (ii) touch screen buttons that trigger image actions are radially located around the image, and / or (iii) primary navigation buttons that are located in corner of the screen, such as the upper right, upper left, bottom right, and / or bottom left of the screen. Image orientation adjustment can optionally allow for user guided, or automated / auto-clocking of images based on anatomical signatures. In one embodiment, the user can rotate the frame orientation manually or use auto-clocking based on anatomical signatures or defined landmarks in the imaging, which can improve user experience by creating consistent image orientations for faster identification of anatomic location and identifying features in the image(s).

[0021] Measurement Screen: In several embodiments, the tablet includes a measurement screen that, for example, can project images and measurements to a separate display. In several embodiments, the workstation includes a measurement screen that, for example, can project images and measurements to a separate display. In several embodiments, a measurement screen provides various ways to measure features in the image(s) and allows the user to view area measurements details in multiple ways such as: length, depth, distance, area, minimum diameter, maximum diameter, average diameter, and other dimensional values. The display can also be customized based on the selected procedure or based on previously defined user preferences. In one embodiment, the measurement screen can include one or more of the following: (i) a left margin of the screen to the left of the image providing an area for measurement details, (ii) a right margin of the screen to the right of the image providing a timeline and interactive recording navigation, (iii) the ability to zoom out to the measurement summary screen, and / or (iv) the ability to quickly toggle between recording-centric views and complete procedure measurement summary (e.g., case summary), screen to compare different images or measurements. In one embodiment, a measurement summary screen provides a zoom out to view a summary of all images and associated measurements (e.g., 4x4, m x n, etc.) and the ability to show a single image. In several embodiments, the system allows the user to toggle to a summary view of all bookmarked images and images with measurements (e.g., 4x4, m x n, etc.) within a procedure. The user can view multiple images at the same time or zoom into a single view for additional details. This feature allows for seamless viewing or editing of measurements.The measurement screen may have the ability to zoom in on a selected image and change to the measurement screen. In one embodiment, blood dynamics using speckle information of neighboring frames to calculate blood movement are provided.

[0022] Tablet Mount: In several embodiments, tablets can be mounted in multiple configurations to component, such as a (i) mounting surface, such as a patient bed rail, (ii) a universal mount, (iii) an articulating mount, and / or (iv) a mobile cart. In one embodiment, a Tablet Mount attaches to a patient bed rail or mobile cart without the universal mount. The bed rail and mobile cart can include a bracket or rail or other mounting surface that is common that supports connection of a mount directly. The tablet mount interface provides, in some embodiments, mechanical support and power to charge the tablet. The tablet mount can include a compatible interface to the tablet docking interface, and securely holds the tablet when connected. Microphones, sound arrays, speakers, Audio Front End (AFE) functions, noise cancelling filters, and processors / chips, are integrated into the tablet mount to support voice recognition functions according to several embodiments. Providing power to the tablet in some embodiments ensures procedures can continue smoothly in the event of a lower battery condition.

[0023] Universal Mount: In several embodiments, a universal mount (such as a Universal Rail Mount (URM) may include one or more of the following: (1) an adjustable rail attachment (e.g., configured to attach to a bed rail or mobile cart), (ii) a mechanical coupling interface configured to mechanically attach a component (e.g., tablet, workstation, device, or other mount), (iii) a power coupling interface configured to deliver power to a component, and / or (iv) one or more positioning mechanisms to adjustably change a position, angle, orientation of a component. In several embodiments, the universal mount transforms bedside rail to a standard interface allow for consistent, simplified accessory placement / attachment. The universal mount may be low profile such that the mount may remain on the bedrail and does not impede bedside access.

[0024] Synergies for Vascular Intervention: In several embodiments, the IVUS system is configured for optimized vascular procedures. Several systems and methods described herein can be used for peripheral, coronary and other intravascular applications. Other embodiments are used in non-vascular intraluminal applications, such as endoscopy.

[0025] For example, endoscopes may be used with several features described herein. Transvaginal and other gynecological ultrasound devices may also include several features described herein. For embodiments in which EUS (endoscopic ultrasound) and other intraluminal imaging or imaging of other body cavities or organs is performed (and such imaging is not in vessel), the features described herein for “IVUS” or “catheters” should be understood to apply to intraluminal (or other cavity / organ) catheters, probes, tubes, scopes and other such devices.

[0026] In some embodiments, the systems and methods are configured and optimized for peripheral vascular procedures (and not for coronary vascular procedures). In one embodiment, systems and methods configured, designed or adapted solely or primarily for the peripheral vasculature comprise one or moreof the following features: flexibility, steerability, length, diameter, material, and / or bending strength for improved pushability, tracking, and crossing (e.g., the ability to cross through obstructions or narrowing) in the lumen. Some of these features may also be incorporated for applications other than peripheral IVUS. In some embodiments, the system is configured to image and / or measure tissue before a therapeutic procedure, such as to identify and plan the therapeutic procedure. In some embodiments, the system is configured to image and / or measure tissue after a therapeutic procedure, such as to confirm the results and outcome of the therapeutic procedure. In some embodiments, the system is configured to image and / or measure tissue during a therapeutic procedure.

[0027] Custom Ultrasound Control Electronics: Custom electronics are used in both the CIM hardware and a plug-in board on the workstation motherboard (e.g., USC board) according to one embodiment. In some embodiments, high speed processing, high dynamic range signal capacity, and high-end signal processing support precise control of transmit waveforms and receive processing to maximum spatial resolution, temporal resolution, and image contrast for superior image interpretation.

[0028] Secure Catheter Identification and Calibration: The catheter includes non-volatile memory that includes unique catheter identification and authentication, usage data, and calibration for optimal imaging performance according to one embodiment.

[0029] Real time and on-demand Vessel Border Detection: The processing power of the systems described herein enables real time and on-demand vessel border detection according to one embodiment. In one embodiment, when the display is paused / stopped the borders can indicate a confidence level either by color or by handle to adjust the border. In one embodiment, when the display is paused / stopped the borders can indicate a global confidence level for the automated border of an image, and / or a local confidence level in select regions of the border. Confidence level can be color coded or otherwise visually depicted on the image. Regions with low local confidence may have a graphical element, or handle, to adjust the border. In one embodiment, the IVUS system provides enhanced catheter navigation in the recorded frames using visualization of real time measured metrics without an external imaging system. In alternate embodiments, external imaging, such as fluoroscopy, is provided. External imaging may be leveraged to provide co-registration of a location of the IVUS catheter during a procedure. In several embodiments, co-registration may be partially or fully automated. In several embodiments, imaging may be conducted without automated co-registration, which may allow for more flexibility to use different components (e.g. components that may be more readily available to physicians and / or components for which physicians already have a level of comfort). Increased speed of procedures, reduced cost of medical care, and better patient outcomes may be accomplished in many embodiments.

[0030] Hands-free Commands / Voice Control: The ability to have a hands-free interaction with the systems described herein (e.g., IVUS system) allows the clinician to interact with the system without breaking the sterile field according to one embodiment. In several embodiments, voice commands provide hands-free tasks and assist in measurement and real time border detection. A unique aspect of voice control utilizes a select set ofcommon system commands with a modernized workflow specific grammar context and social cue inference to allow for a wake-wordless command interaction to support a stream-lined imaging and measurement workflow in several embodiments. In various embodiments, hands-free voice control interaction allows the user to control the system without breaking the sterile field. In several embodiments, the voice command set has a direct correlation to the modernized user interface displayed on the tablet. In several embodiments, the system has a modernized workflow that enhances user experience and overall usability. In some embodiments, the system (e.g., interactive user device such as a tablet or other components) may include a camera that captures hand gestures, which are interpreted and converted into system commands.

[0031] Native Image Data Collection and Cloud-based Storage: In some embodiments, the systems described herein are designed to support native ultrasound sensor data collection. In several embodiments, sampled signal data includes amplitude and / or phase. This data, for example, is complete without loss including both phase and amplitude stored in a proprietary format and archived in a cloud-based data lake. This high-fidelity ultrasound data is used in one embodiment to drive future improved image generation and image interpretation, and optionally leveraging artificial intelligence and / or machine learning.

[0032] Remote Management, Service and Data Analytics: In several embodiments, the platform includes stream-lined device management that provides the ability for preemptive maintenance actions based on system metrics to maximize system availability and uptime. Insights into usability metrics can provide input for product refinements. Remote system management with procedure usage monitoring and dynamic preventative maintenance notification are provided in some embodiments. In some embodiments remote management can also include notifying IVUS System that updated software and / or firmware is available and allow for manual or automatic methods and systems to download the new software to the systems and install them.

[0033] Innovation Life Cycle Management: The system is a platform that will quickly improve based on input from both Data Analytics and Native Image Data Collection according to one embodiment. Product evolution managed through a lifecycle model includes for example: Native Data -> AI / ML feature dev -> Validation -> Remote Service Deployment.

[0034] Multi-Channel Processing Pipeline: The processing power of several embodiments described herein enable a unique data processing architecture featuring multi-channel processing according to one embodiment. Multi-channel processing allows for real time processing and image processing for the display of human interpretable images, while also processing for automated and / or semi-automated, computer based, image interpretation according to some embodiments. Using multi-channel processing, one or more processors may route data from a plurality of data sources, through a plurality of data processing pipelines, and route the IVUS image data to a plurality of data sinks. In one embodiment, the IVUS system is configured for multi-stream processes. In several embodiments, the IVUS system uses a multi-channel processing infrastructure that enables a unique data processing architecture featuring multi-channel processing. Multi-channel processing allows for real-time processing and image processing for the display of human interpretable images, while also processing for automated, computer based, image interpretation according to some embodiments. In one embodiment, the multi- channel processing infrastructure utilizes a complex data processing infrastructure that can combine data streams from multiple data sources, process them in a configurable set of data processing pipelines, and route them to a configurable set of data sinks. Flexible configuration for the data sources, data processing pipelines, and data sinks allows for assembling the infrastructure at runtime and reuse of components and sub-components according to some embodiments.

[0035] Workstation: A workstation is a high-performance computer that includes a central processing unit (CPU), volatile memory, graphics processing unit (GPU), disk non-volatile storage, wireless antennas, and custom ultrasound transmit and receive electronics according to one embodiment. The workstation can be the computation hardware unit for the easy to use workstation software. The workstation can be a high- performance computation unit that includes GPU processing to support edge-based AI / ML computations in real time, or on-demand. Standard discrete workstation GPU(s) and an interface executed by the workstation can provide the platform to leverage rapid pace of progress in commercial GPUs. The workstation can provide connectivity and data analytics, remote diagnostic, service, and / or upgrade capabilities. In several embodiments, the IVUS system includes electronic storage (e.g., secure catheter ID, customized acoustic data, usage data, etc.). In one embodiment, the workstation includes high-speed DRAM to capture an entire pullback study of raw ultrasound data for live viewing and on-demand post-processing after the pullback is complete.

[0036] Mobile Cart: A compact mobile cart is provided that comprises a set of mechanicals including chassis and wheels that provides a mobile configuration and provides interfaces for a tablet mount, an articulating mount, a universal mount, workstation, and storage for a catheter interface module (CIM) and a system cable, according to one embodiment. In various embodiments, power (AC, DC, battery, etc.) may be supplied from the workstation and / or mobile cart.

[0037] Automatic Configuration of Networked Components and Accessories: In several embodiments, the IVUS system may be used within a single hospital or clinic network to automatically discover workstations and exchange information on how to connect to them. The user (e.g., clinician, assistant, technician, trained service technician, IT administrator, etc.) can be presented with a list of discovered IVUS workstations and can associate a component / accessory with a single click. Communication parameters, e.g., IP addresses and ports, can be configured automatically. In one embodiment, zero configuration networking (e.g., zeroconf) can create a computer network when computers or peripherals are interconnected using automated assignment, distribution, and location data for networked devices. In some embodiments, cybersecurity aspects such as the discovery and information exchange can be protected with a security features, e.g., security keys.

[0038] Maximized local network WIFI Bandwidth and Synchronization Protocol for Multiple Clients: in various embodiments, a combination of internal Wi-Fi card, its driver settings (e.g., Linux driver), andconfigurations in Access Point mode (e.g., wireless protocol, encryption, band, channel, etc.) can create, for example, a wireless network (e.g., akin to a hotspot) with enough bandwidth (e.g., with at least a 250 KB frame size and 60 fps, and 2 client devices, or 240 Megabits per second) to support two or more tablets. In one embodiment, the network has a synchronization protocol that keeps (i) the latest state of the workstation synced to the two or more tablets, (ii) the latest state of a master-tablet can be synced to a secondary-tablet in the face of disconnectivity (e.g., failure of power, network, etc.). A combination of underlying network-architecture overlaid with this application-level network-protocol will achieve low latency and simultaneous ease-of-use for hospital personnel in several embodiments. Combinations of the features above, in several embodiments, advantageously provide ease of setup, reduced cognitive load, streamlined user interactions and efficient clinical workflow. In several embodiments, the IVUS system provides image centric approach for image controls buttons, simplified case browsing, timeline interaction, implicit recording vs. explicit recording, labeling, compound measurements, and / or procedure summary reporting.

[0039] In several embodiments, imaging as described herein is used to diagnose whether a patient is suitable for a particular intervention or further diagnostics. In various embodiments, 2D and / or 3D intraluminal visualization is enabled. In one embodiment, 2D imaging includes an image in a single plane. In several embodiments, 3D imaging includes a volumetric representation of tissue or a lumen. In some embodiments, 3D imaging is reconstructed via algorithms interpolating a series of 2D images across a third dimension, taking a series of individual 2D images and estimating linear progression along the third dimension, and may employ AI to produce a 3D volumetric representation of the interpolated 2D images. In some embodiments, 3D model generation may involve obtaining 2D cross-sectional images of a vascular object such that a position along the vein or artery (e.g., an insertion length) can be recorded by an encoder or other sensor. Drawing each 2D cross section in 3D at the insertion length at which the cross section was recorded can allow a 3D model of the vascular object to be built. In one embodiment, adding an electro-magnetic sensor to the catheter tip can allow the position of the catheter tip to be recorded as the 2D images are obtained, thus allowing a 3D model of the vascular structure to be created. In one embodiment, one or more algorithms convert series of IVUS 2D images and signal data into volumetric 3D visualization. In one embodiment, 3D visualization is produced via interpolation of linear and / or nonlinear vascular structure geometry and acoustic reflections from a tissue. In one embodiment, pixel based interpolation is used to visualize vascular anatomy in three dimensions. In several embodiments, a series of cross sectional two dimensional IVUS images and / or signals are generated via pixel based cut view images of a vessel showing acoustic reflection information along a length of a lumen. In one embodiment, 3D visualization is produced via algorithms for creating anatomical contour borders via smooth 3D surface rendering. In several embodiments, AI is employed to create 3D visualization data and images.

[0040] In several embodiments coronary systems and methods are provided. In several embodiments, devices (such as coronary IVUS catheters) employ larger diameters, higher rigidity, and modifiedcoronary specific pushability, tracking, and / or crossing characteristics. Catheters for coronary applications may apply different ultrasound frequencies to account for variance in tissue lumen size: for example, the peripheral vasculature may have larger vessel diameters, so lower frequencies can be used for ultrasound imaging to image at farther distances from the center / IVUS catheter. In some embodiments, coronary vessels have smaller diameters, so may use imaging ultrasound frequencies around 60 MHz, while peripheral imaging may use lower frequencies, such as around 40 MHz or less. In some embodiments, coronary application may also measure pressure within the lumen via a Fraction Flow Reserve (FFR) wire. In some embodiments, coronary IVUS catheters may employ a larger diameter guide catheter to surround part or all of the coronary IVUS catheter, with IVUS imaging employed when partially extended from the guide catheter. In some embodiments, coronary IVUS catheters need less column strength for pushability or crossing because of the presence of a guide catheter.

[0041] In several embodiments, image enhancement may include, for example, resolution and / or contrast image enhancement to improve image quality. The image enhancement may include a nonlinear image enhancement (NLIE) function that can preserve edges and facilitate edge detection enhancements that make it easier for an AI / ML algorithm to find features of interest. For example, NLIE may be configured for improving edge and detail image quality and / or reducing noise and / or blurs from images by, for example, removing portions of an image if the portion does not meet a threshold probability of accuracy value.

[0042] In several embodiments, catheters are optimized for vascular imaging are configured for superior pushability, tracking, and crossing for arterial and venous peripheral vasculature. In several embodiments, one or more of the following features are provided:

[0043] Pushability: In several embodiments, catheters have superior pushability to avoid kinking with sufficient column strength to advance the catheter through tortuous bends and occlusions in vasculatures without buckling, over bending, or collapsing anywhere along the catheter (e.g., proximate or (e.g., ability to cross an occlusion or constriction). Material properties in some embodiments (e.g., balance of rigidity and flexibility, durometer in various segments), dimensional characteristics (e.g., larger dimensions, such a diameter and thickness, increase column strength, account for greater pushability and kink resistance.

[0044] Tracking: In several embodiments, catheters have superior tracking for the ability of the catheter to follow a guidewire through tortuous bends in vasculature, having sufficient flexibility and strength to move along and advance along a guidewire to target locations within the vasculature. Hydrophilic coatings according to some embodiments help reduce friction with guidewires and the surrounding luminal tissue.

[0045] Crossing: In several embodiments, catheters have superior crossing capabilities to cross occlusions, restrictions and constrictions within the vasculature, such as at sites with tissue blockage (e.g., stenoses, etc.) and / or implant blockages (such as stents, balloons, etc.). According to some embodiments, crossing ability is enhanced by one or more of the following: (i) design of the distal tip (e.g., pointed enough to navigate occlusions, etc. and blunt enough not to snag on an occlusion), (ii) material properties (e.g., balance ofrigidity and flexibility, durometer in various segments, etc.) and / or (iii) dimensional characteristics (e.g., larger dimensions, such a diameter and thickness, increase column strength). In one embodiment, low durometer near the distal tip is provided for flexibility to navigate tortuous anatomy and obstructions. In one embodiment, a region of varying or step wise gradient changes to a higher durometer proximally sufficient to push the catheter while avoiding kinking is provided. A single durometer and / or flexibility can remain constant along a certain or all portions of a device.

[0046] In several embodiments, an IVUS system comprises a workstation with a computer with a CPU, memory, a GPU, storage, wireless antennas, software, and electronic circuitry to transmit and receive data. In one embodiment, the GPU is a high-performance computation unit that includes or consists essentially of GPU processing to support edge-based AI / ML computations in real time, or on-demand. In one embodiment, a discrete workstation GPU and interface provides platform to leverage rapid pace of progress with GPUs. In several embodiments, one or more discrete workstation GPUs may be used.

[0047] In one embodiment, the workstation includes or consists essentially of a motherboard component, and a USC board. The ultrasound system control board provides, in several embodiments, high speed processing, high dynamic range signal capacity, and high-end signal processing to support precise control of transmit waveforms and receive processing to maximize spatial resolution, temporal resolution, and image contrast for superior image interpretation. The ultrasound system control board may interface to one or more drivers. The one or more drivers may create and register characteristics of devices (e.g., PCB and registration of each catheter and its individual characteristics). In some embodiments, the one or more drivers may allocate memory in a kernel.

[0048] In various embodiments, the system (such as the IVUS system) provides real time and on- demand vessel border detection using processing by the workstation. In various embodiments, the system (such as the IVUS system) provides real time and on-demand vessel border detection using processing by the tablet. In various embodiments, the system provides capability for hands-free commands and voice control, allowing the clinician to interact with the system without needing to break the sterile field around the patient. In one embodiment, a unique aspect of voice control utilizes a select set of system commands with a workflow specific grammar context and social cue inference to allow for a wake-wordless command interaction to support a stream-lined imaging and measurement workflow. Social cues may be verbal, such as a wake word, or non-verbal. Non-verbal cues may be based on the context of the command and / or an anticipated next action. In one embodiment, for simplicity, verbal requests may be limited to the same options presented by the user interface in a traditional button selection approach. The grammar associated with verbal requests, when matching the visual UI presented to the user, allows the system to highlight, or visually distinguish, voice activated control items from those that are not in an embodiment. In one embodiment, in order to enable a non-verbal social cues interaction the system ignores dialog not intended for interpretation and verbal commands. Rejecting dialog is provided for robust detection performance in some embodiments. Verbal commands may include a plurality of commands associated with elements in atouch-user interface. For example, a length measurement element may be provided in a touch-user interface, and the plurality of verbal commands may include a “show measurements” command. In some embodiments, grammar of the verbal command may be analyzed, and based on the grammar analysis, the system may highlight elements of a touch user interface related to the command. Returning to the example above, the “show measurements” command may be analyzed, and the system may highlight the measurements element based on the grammar analysis of the command. In one embodiment, voice control is provided to enhance ease of setup and use of the systems described herein.

[0049] In one embodiment, a voice control social cue may be either a wake-word, or inferred based on a pre-set minimum duration of silence before followed by a valid command. In one embodiment, volume level filtering with commands uttered below a specific acoustic level will be ignored to increase robustness. In one embodiment, the system includes audio filtering to lower the amplitude, or volume, of sounds not emanating from the direction of the user. The system can attempt to recognize the voice command phrase uttered after the minimum duration of silence. If the phrase is not recognized, the command will be ignored, and the system will resume waiting for the next social cue according to one embodiment. In several embodiments, the voice processor (tablet or tablet mount, or workstation) is configured for determining social cue. For example, in various embodiments a wake mode may be entered by social cue; a wake mode or command mode does not require a wake word to precede voice commands; and / or a wake mode may terminate based on a predefined duration or change in workflow state. Social cue may be a change in a workflow state, with a wake word, and / or a period of silence preceding a voiced command. Social cues may allow for improved voice interaction by reducing false positive voice responses.

[0050] In one embodiment, a command may be to start an annotation. Annotations can be either manually entered through typing on a physical or virtual keyboard or dictated and transcribed using voice-to-text processing. The type of command could indicate the type of annotation to initiate. In some cases, the annotation could be a simple label which could be constrained to a specific list of options similar to a drop-down list in a graphical user interface.

[0051] In several embodiments, the systems described herein employ native image data collection and cloud-based storage. The platform is uniquely designed, in one embodiment, to support native ultrasound sensor data collection, wherein the data is complete without loss including both phase and amplitude stored in a proprietary format and archived in a cloud-based data lake. This high-fidelity ultrasound data may be used to drive future improved image generation and image interpretation.

[0052] The systems described herein may employ remote service and data analytics including stream-lined device management in some embodiments. This provides the ability for example, for preemptive maintenance actions based on system metrics to maximize system availability and uptime. Insights into usability metrics can provide input for product refinements.

[0053] In one embodiment, the innovation life cycle management provides a platform that provides further enhancements based on input from both data analytics and native image data collection. In one embodiment, product evolution is managed through a lifecycle model: (i) Native Data -> (ii) AI / ML feature development -> (iii) Validation -> (iv) Remote Service Deployment.

[0054] A multi-channel processing pipeline is provided in one embodiment to provide a unique data processing architecture featuring multi-channel processing. Multi-channel processing, in one embodiment, allows for real time processing and image processing for the display of interpretable images, while also processing for automated and / or semi-automated, computer based, and / or image interpretation. In one embodiment, image series measurements with multi-frame, multi-channel processing is configured for one or multiple images. Using multi-channel processing, the processor may route data from a plurality of data sources, through a plurality of data processing pipelines, and route the IVUS image data to a plurality of data sinks. Meta data such as time and data descriptors can be maintained throughout the different processing steps to maintain the relationship of the different data types at all stages of the multi-channel processing pipeline. In various embodiments, data sources may be sensors, data sampling hardware, data generating sources (computations, simulations), etc. Each Data Processing Pipeline may have a unique set of processing operations or filters. Filters may have an input buffer, which can be a single data block or a series of data blocks. Filters can access all data blocks in the input buffer according to some embodiments. Data Sinks may consume one or more data channels and utilize them individually or in combination. A data sink can also become a new data source which allows to daisy chain pipelines. In one embodiment, the IVUS system is configured for multi-stream processes. In one embodiment, multi-channel processing pipeline is configured synchronous to ultrasound acquisition timing, via decimated by N periods to allow processed aggregated data blocks.

[0055] In one embodiment, the IVUS system reduces user cognitive load by streamlined user interactions and to provide an efficient clinical workflow and to enhance ease of setup and / or ease of use. The user interface uses, in one embodiment, an image centric approach for any one or more of image controls buttons, simplified case browsing, timeline interactions, implicit recording, explicit recording, labeling, compound measurements, and procedure summary reporting. In several embodiments, compound measurements include: (i) computation of cross-frame and cross-recording metrics such as blockage to provide guidance to a clinician and procedure reporting, (ii) computation of metrics within a single image or across multiple images acquired during a procedure, (iii) measurements such as include percent stenosis, ratios of maximum to minimum diameters, ratios of maximum to average diameters, ratios of minimum to average diameters, and customized compound measurement types based on selected procedure type or user preferences (e.g., customized by user, procedure type, labels, streamlines work flow, user defines for customized measurements and reporting). A procedure report may be generated automatically during or after an IVUS procedure. The report may be viewed and / or edited before, during, or after one or more procedures according to some embodiments. The report mayinclude: a summary of case information, a patient history, a patient identifier, time stamp(s), measurements (including key measurements) used for diagnosis or treatment, manual and automated measurements, computations (e.g., for stenosis or other conditions), computations of cross-frame metrics (e.g., blood flow and lumen diameter), automatic and / or user annotations (via touch, gesture, voice, etc.), time-sequence summaries, and / or notes and / or dictation provided by a user. Measurements may include compound measurements taken using an IVUS image or a plurality of IVUS images. For example, a measurement may include percent stenosis of a vessel. In one embodiment, compound measurements include computation of cross-frame and cross-recording metrics such as blockage to provide guidance to a clinician and procedure reporting.

[0056] A tablet that is hand-held, wireless, and has a touchscreen is provided in some embodiments to interface with the devices described herein. In one embodiment, the wireless tablet is designed to support flexibility in lab setup while minimizing cabling. The tablet may include one or more speakers and one or more microphones. In one embodiment, the tablet is a user interface for the IVUS system. In various embodiments, the tablet is removably attachable to a tablet mount. The tablet mount may include one or more clamps, levers, linkages to hold a tablet in place around a patient or an IVUS system operator. The tablet mount may be attachable to a bed, such as a bed rail. A tablet mount can include, for example, a universal mount which may attach to any bed rail, cart, IV pole, IVUS system component, or furniture. In one embodiment, the tablet screen is used to display one or more ultrasound images, alone or in conjunction with a separate monitor. Additional monitors may also be provided.

[0057] In several embodiments, an IVUS system comprises a CIM that includes a hardware interface between a system cable from the workstation and one or more disposable catheters. The CIM custom electronics can control a motor that rotates an imaging core inside the catheter. The CIM electronics can transmit and receive ultrasound signals between a spinning imaging transducer in a distal end of the catheter tip and the custom USC board inside the workstation. For example, the CIM may transmit ultrasound signals, sensor data, and / or catheter information from an IVUS catheter to a workstation and / or at least one tablet, which may store the transmitted information in a non-volatile memory. In one embodiment, the CIM may be mounted using a bracket common to a mobile cart and tablet mount with or without a universal mount. The bracket may attach the CIM to any bed rail, cart, IV pole, IVUS system component, or furniture. In one embodiment, the CIM may be transported on a cart.

[0058] Imaging and diagnosis of intravascular or extravascular tissue is accomplished herein in several embodiments, including identification of irregularities. The term “irregularities” as used herein may be given its ordinary meaning and shall also include vascular or other malformations, constrictions, occlusions, dilations, disease, and injury. Irregularities may also include lesions, thrombus, aneurysm, dissection, plaque (e.g., hard plaque, soft plaque, vulnerable plaque, calcified plaque, substantially non-calcified plaque, fibro-fatty plaque), thrombus, fistulas, tumors, neoplasia, gallstones, kidney stones, polyps, cysts, etc., and measuring morphologyassessment wherein such irregularities are within vessels, other bodily lumens or other target sites. In several embodiments, irregularities may also include stent or balloon malapposition, dissection (e.g., post atherectomy, post balloon angioplasty, etc.), determining etiology of compression, under-expansion of a stent or other device, and issues with IVUS-guided sizing and grading of severity of an irregularity or under expansion of a stent, such as an iliac vein stent. Irregularities in the esophagus, stomach, and small intestine may be viewed using several embodiments described herein (e.g., through endoscopic ultrasound imaging). Tumors include, for example, fibroids, polyps, abnormal cell clusters, etc. and may be benign or cancerous, including but not limited to those located in reproductive organs such as the uterus, the nasal or ear cavity, rectum, colon, other intestinal regions or elsewhere.

[0059] In addition to the identification of irregularities, several embodiments herein are used to facilitate relevant measurements and preparation for deploying stents and / or balloons, and are useful for planning of treatment by medical practitioners.

[0060] After identification of irregularities, appropriate treatments may be used on the patient. For example, image-guided treatment of tumors, thrombus, plaque, etc. may be used in which imaging and therapeutic capabilities exist on a single device or multiple devices. Several embodiments include, for example, percutaneous coronary intervention for coronary artery lesions, intravascular imaging-guided percutaneous intervention for peripheral vascular lesions, and / or intravascular imaging-guided percutaneous interventions in arteries and / or veins. In several embodiments, the IVUS system is configured for optimized peripheral vascular procedures. In several embodiments, the IVUS system is configured for optimized peripheral vascular procedures and is not configured for coronary vascular procedures. In several embodiments, the IVUS system is configured for coronary procedures.

[0061] Although several embodiments described herein described IVUS, the technology described herein are also used for intraluminal imaging (other than intravascular). For example, several embodiments are used for imaging, diagnosing, and / or providing an image-guided intervention in the digestive tract (including but not limited to colonoscopy, endoscopy, etc.), esophagus, stomach, intestine, rectum, sinus (including ENT for example), ureter (and other urological tissue), bladder, uterus, fallopian tubes, etc. The systems and methods described herein may be used in conjunction with an endoscope rather than an IVUS catheter and support identification and diagnoses of gastrointestinal tumors, such as tumors in the intestines and / or biliary ducts. Similarly, the systems and methods described herein may be used to image a sinus cavity (or other ENT application) using IVUS. Tumors that can be visualized and optionally treated according to several embodiments herein include, for example, fibroids, polyps, abnormal cell clusters, etc. including but not limited to those located in reproductive organs such as the uterus, the nasal or ear cavity, rectum, colon, other intestinal regions or elsewhere. ENT (ear, nose, throat) visualization are provided in several embodiments, as are ocular application to help image various eye structures.

[0062] The technology described herein, including the mounts, voice control, ease of setup and providing for set up outside a sterile field with catheters with lengths of 8 feet or more are used in several embodiments with flush-less, sealed encapsulated acoustic coupling medium IVUS catheters to reduce air bubbles and eliminate the need to flush catheters including the technology described in U.S. Patent Serial No.63 / 459,312 entitled Systems and Methods for Flush-Less Intravascular Ultrasound Catheter, U.S. Patent Serial No. 63 / 546,091 entitled Systems and Methods for Flush-Less Intravascular Ultrasound Catheter, and International Patent Serial No. PCT / US2024 / 024045 entitled Flush-Less Intravascular Ultrasound Technology; intraluminal image focusing with spinning single element ultrasound transducer via modification of image (e.g., angular diffraction, phase, amplitude, time shift, compositing backscatter reflected images) including the technology described in U.S. Patent Serial No. 63 / 497,962 entitled Spinning Single Element Ultrasound Transducer and Focusing Methods and International Patent Serial No. PCT / US2024 / 024035 entitled Spinning Single Element Ultrasound Transducer and Focusing Technology; manually assisted pullback for spatial alignment measurements, voice control, position sensors (e.g., encoder) including the technology described in U.S. Patent Serial No. 63 / 531,266 entitled Systems and Methods of Manually Assisted Pullback for Spatial Alignment Lengthwise Measurements in Intravascular Ultrasound Imaging and International Patent Serial No. PCT / US2024 / 041134 entitled Systems and Methods of Manually Assisted Movement for Spatial Alignment Lengthwise Measurements in Intravascular Ultrasound Imaging; and circuitry and electronic architecture including the technology described in U.S. Patent Serial No.63 / 632,966 entitled Electronic Architecture For Intravascular Ultrasound Technology, all herein incorporated by reference.

[0063] In various embodiments, the IVUS catheter is configured for imaging (alone or in combination with therapy) tissue, blood, and / or plaque (e.g., any one or more of hard plaque, soft plaque, vulnerable plaque, calcified plaque, substantially non calcified plaque). In various embodiments, the IVUS catheter is configured for imaging thrombus within blood. In several embodiments, the technologies described herein are used for one or more of the following: identification of thrombus, dissection, calcium severity, vessel measurement, and / or preprocedural and postprocedural planning. In several embodiments, the technologies described herein are used to guide the sizing of stents, identify stent placement, apposition and / or expansion, assess lesion morphology, vascular wall thickening, loss of luminal patency, and / or vascular insufficiency, quantify plaque burden, identify complications from procedures, and / or evaluate stent failure with stent thrombosis or in-stent restenosis. The technologies described herein can distinguish between blood, lipids, calcified plaque, and tissue proliferation. In many embodiments, better imaging detail is provided than, for example, angiography.

[0064] In several embodiments, an ultrasound imaging system comprises (i) a catheter comprising a catheter lumen and an imaging core; (ii) a catheter interface module comprising a motor; and (iii) a processor. The imaging core may comprise a single element ultrasound transducer and is configured to rotate within the catheter lumen. The catheter interface module may be configured for mechanical and electrical connection to thecatheter, wherein the motor is configured to rotate the imaging core within the catheter lumen. The processor is configured to, for example: (i) automatically calculate one or more measurements of a vascular lumen from an image imaged by the imaging core, (ii) automatically identify an edge of the vascular lumen; (iii) calculate one or more confidence values associated with one or more sections of the edge of the vascular lumen; and / or (iv) provide a graphical representation of the edge of the vascular lumen to be displayed in real time as an overlay on the image, wherein the graphical representation of the edge of the vascular lumen is divided into the one or more sections of the edge of the vascular lumen based on the one or more confidence values associated with each of the one or more sections of the edge of the vascular lumen. The catheter may be an IVUS catheter or adapted for another bodily lumen.

[0065] In various embodiments, the imaging system, which may be IVUS, intra-luminal, etc., may include one or more of the following: (i) a configuration to make one or more measurements that are selected from the group consisting of: a maximum diameter of the lumen (e.g., vascular lumen), a minimum diameter of the lumen, and an average diameter of the lumen, (ii) a processor that is configured to detect the edge of the lumen using a detection algorithm interpolating a plurality of points on the graphical representation of the edge of the lumen, (iii) a processor that is configured to display a confidence indicator based on the one or more confidence values, (iv) a confidence indicator that is a color-coded confidence value located on the one or more sections of the edge of the lumen, (v) a processor that is configured for image analysis using an artificial intelligence algorithm to identify a vessel border, (vi) a processor that is configured for image analysis using an artificial intelligence algorithm to identify a location or a type of plaque in a peripheral vascular system, (vii) the processor is configured for real time multi-channel processing and image processing for a display of human interpretable images, while also processing for automated, computer based, image interpretation, and / or (viii) a processor that is configured for classifying tissue type for one or more locations of interest in a lumen (e.g., vessel) of a patient, wherein the processor is configured to: receive image data of the lumen of the patient; extract patient-specific vessel / lumen geometry of the patient from the ultrasound image data; extract geometric features from the patient-specific lumen geometry of the patient; and classify different types of tissue for one or more locations of interest in the lumen based on extracted geometric features using a trained machine-learning based model trained based on ultrasound images obtained from ultrasound catheters operating at different frequencies and based on ultrasound images of multiple different types of lumens (e.g., vessels).

[0066] In several embodiments, the processor is configured for assessing a lumen (such as vessel) of a patient, wherein the processor is configured to: (i) receive intravascular ultrasound image data of the vessel of the patient; (ii) extract information from the intravascular ultrasound image data of the vessel of the patient; (iii) store the information in memory; and / or (iv) classify different types of tissue for one or more locations of interest in the vessel based on the extracted and stored information using a trained machine-learning based model that is trained based on intravascular ultrasound images obtained from intravascular ultrasound catheters operating atdifferent frequencies and based on intravascular ultrasound images of multiple different types of vessels. Instead of a vessel, another bodily lumen may be assessed as described herein.

[0067] In several embodiments, the processor is configured for assessing a lumen (such as a vessel) of a patient, wherein the processor is configured to the processor is configured for assessing a vessel of a patient, wherein the processor is configured to: (i) receive one or more intravascular ultrasound images of the vessel of the patient; (ii) extract data from the one or more intravascular ultrasound images; (iii) store the data in memory; (iv) perform a vessel feature detection task on the extracted and stored data using a machine learning based model trained to detect at least a first vessel feature in intravascular ultrasound image data, wherein performing the vessel feature detection task comprises generating an automated output associated with the first vessel feature; and / or (v) utilize the automated output associated with the first vessel feature, performing a tissue classification task using a machine learning model trained to classify tissue in the one or more intravascular ultrasound images, wherein performing the tissue classification task comprises generating an automated result of the tissue classification task. Instead of a vessel, another bodily lumen may be assessed as described herein.

[0068] In several embodiments, a method of enhanced ultrasound imaging for real time border detection includes: (i) receiving an intravascular ultrasound (IVUS) image of a tissue from a rotating imaging core in an IVUS catheter lumen; (ii) automatically identifying an edge of a tissue in the IVUS image; (iii) calculating one or more confidence values associated with one or more sections of the edge of the tissue; and / or (iv) providing a graphical representation of the edge of the tissue to be displayed as an overlay on the IVUS image in real time, wherein the graphical representation is divided into the one or more sections of the edge of the tissue with a confidence indicator based on the one or more confidence values associated with each of the one or more sections of the edge of the tissue. In several embodiments, the method of enhanced ultrasound imaging for real time border detection is performed in a bodily lumen other than a blood vessel.

[0069] In various embodiments, the method may include: (i) receiving an input from a user, (ii) identifying a custom edge of the tissue based on the identified edge and the input from the user; (iv) updating the graphical representation of the edge of the tissue further comprising the custom edge, (v) performing edge-based machine learning computations associated with the image, (vi) detecting, via one or more processors, a vessel edge, (vii) receiving a user input and detecting the vessel / lumen edge based on the user input, (viii) performing, via one or more processors, a multi-channel processing of the image, and / or (ix) wherein the multi-channel processing provides real time processing and image processing for the display of human interpretable images, while also processing for automated, computer based, image interpretation.

[0070] In several embodiments, a method of enhanced intravascular ultrasound imaging for real time boundary detection includes: receiving one or more ultrasound image frames (such as IVUS or images from other lumens / regions), detecting a vessel / lumen boundary using one or more boundary detection algorithms, and / or calculating a confidence value for a portion of the boundary, wherein a confidence indicator is displayed onthe overlayed boundary based on the confidence value, wherein the one or more boundary detection algorithm comprises an AI and / or machine learning algorithm. The method may also include receiving a modified vessel / lumen boundary data from a user, and recalculating a modified confidence value based on the modified vessel / lumen boundary. In addition to detecting the boundary of a vessel or other lumen, the boundary of abnormalities may also be detected. For example, tumor boundary edge detection is provided in several aspects.

[0071] In several embodiments, an IVUS imaging system is provided. The IVUS imaging system includes (i) an IVUS catheter; (ii) a catheter interface module that includes a motor and is configured for removable mechanical connection to a catheter interface module mounting surface on a patient chassis; (iii) a tablet configured to receive at least one input from a user; (iv) a workstation configured for electrical connection to the catheter interface module and the tablet; and (v) a tablet mount comprising one or more microphones, an electrical contact, a first tablet mount interface, and a second tablet mount interface. The one or more microphones may be configured to receive a verbal command from a voice of the user, wherein the one or more microphones are configured to be placed in communication with the tablet. The electrical contact may be configured to provide power from the tablet mount to the tablet. The first tablet mount interface may be configured for connecting to the tablet via a releasably attachable interface, wherein the releasably attachable interface comprises a latch. The second tablet mount interface may be configured for removable mechanical connection to at least one of: a tablet mounting surface on the patient chassis, a mobile cart, an articulating mount, and a universal mount.

[0072] Optionally, catheter interface module can be placed outside a sterile field and can be repositioned on the mounting surface on the patient chassis. In several embodiments, the tablet mount can be placed outside a sterile field and can be repositioned on the mounting surface on the patient chassis. In several embodiments, the tablet mount can be placed inside a sterile field. The tablet mount can optionally be connected to the articulating mount that includes one or more articulator arms and a joint, wherein the joint may be configured to lock, unlock, and reposition a position of the one or more articulator arms. In several embodiments the tablet mount can be connected to a universal mount which may in turn be connected to a universal mounting surface on the patient chassis. Optionally, the one or more microphones of the tablet mount may include one or more microphones (e.g., single microphone, plurality of microphones, microphone array, directional microphone, unidirectional microphone, and / or omnidirectional microphone, etc.). In one embodiment, one or more microphones are configured to handle up to a 180 degree (e.g., 45 degree, 90 degree, 120 degree, 180 degree and values and ranges therein) spread of microphones. The tablet mount may optionally be configured to: (i) identify a direction of the verbal command; (ii) determine the direction of the verbal command (e.g., is toward the tablet mount or away from the tablet mount); and (iii) transmit the verbal command to the tablet, tablet mount, or workstation in response to determining the direction of the verbal command is toward the microphone. The tablet mount may optionally be configured to: (i) tune to a direction of the verbal command based on lab configuration settings established during setup; (ii) determine whether the direction of the verbal command is from thepreconfigured direction; and (iii) determine if the verbal command matches the workflow specific grammar, then translates the verbal command to an actional command sent to the workstation. The tablet mount may optionally be configured to determine a speaker who generated the verbal command, suppress competing speakers generating speech outside the speaker direction; and / or transmit the verbal command to the workstation in response to determining that the speaker was the user. In several embodiments, the tablet mount may be configured to (i) determine a speaker who generated the verbal command; and (ii) transmit the verbal command to the workstation in response to determining that the speaker was the user. In various embodiments, voice input may be replaced by or used in conjunction with touch input via the tablet, tablet mount, or workstation. In various embodiments, voice or touch input may be processed by the tablet. In one embodiment, voice input can be sent to the workstation for processing, then sent to the tablet as a voice command. For example, the input could come from the user via touch interaction (e.g., activating a mechanical button, touching a touch screen, etc.), or from the workstation via voice input from the user at the tablet mount / tablet. In several embodiments, the tablet mount may be substituted by the tablet.

[0073] In several embodiments, the tablet mount may be configured to filter one or more signals detected by the one or more microphones based on one or more of: a frequency, a variance, and an amplitude of the one or more signals detected by the one or more microphones. In several embodiments, the tablet may be configured to filter one or more signals detected by the one or more microphones based on one or more of: a frequency, a variance, and an amplitude of the one or more signals detected by the one or more microphones. The workstation may be configured to update a user interface based on the verbal command. The workstation may optionally determine one or more of a grammar context and a social cue context of the verbal command. In several embodiments, the workstation may initiate at least one voice interaction with an element of the user interface based on the verbal command. The element of the user interface may include at least one of: a live image element, a label element, a screen capture element, a length measurement element, an area measurement element, an automation element, a brightness control element, a zoom control element, a measurement summary element, a IVUS image loop element, and a timeline element. In several embodiments, the tablet mount may be substituted by the tablet.

[0074] In various embodiments, the workstation may optionally be configured to (i) select the automation element based on the verbal command; (ii) automatically calculate one or more measurements of a vascular lumen imaged by the IVUS catheter, the one or more measurements comprising: a maximum diameter of a vascular lumen imaged by the IVUS catheter, a minimum diameter of the vascular lumen, and an average diameter of the vascular lumen; and (iii) provide an IVUS image and the one or more measurements to be displayed. In several embodiments, the workstation may be configured to (i) select the automation element based on the verbal command; (ii) automatically identify one or more irregularities in the vascular lumen imaged by the IVUS catheter; and (iii) provide a graphical representation of the one or more irregularities to be displayed as anoverlay on the IVUS image. The workstation may optionally be configured to calculate at least one property of the one or more irregularities; and provide the graphical representation of the one or more irregularities to be displayed, the graphical representation further comprising the at least one property. The at least one property may include at least one dimension and an irregularity type.

[0075] Optionally, the ultrasound imaging system may comprise (i) a configuration to make one or more measurements comprising one or more of: a maximum diameter of the vascular lumen imaged by the IVUS catheter, a minimum diameter of the vascular lumen, and an average diameter of the vascular lumen, and an area of the vascular lumen, (ii) a configuration to make one or more measurements that comprises one or more compound measurements, the one or more compound measurements comprising measurements calculated based on a plurality of IVUS images, and / or (iii) a configuration to make one or more compound measurements that comprise a percent stenosis of a vessel, one or more ratios of maximum to minimum diameters, one or more ratios of maximum to average diameters, one or more ratios of minimum to average diameters, and / or a computation of cross-frame and cross-recording metrics including blockage. Before, after or during taking measurements, the system is further configured, in some embodiments, to: (i) generate one or more IVUS images that comprise one or more of: a longitudinal series of IVUS images or a temporal series of IVUS images, (ii) provide one or more graphical representations corresponding with the one or more measurements via for example a workstation and / or tablet, (iii) generate a graphical representation (e.g., a bar graph) that is two-dimensional or three-dimensional. In some embodiments, instead of a vascular lumen, the system is adapted to make measurements of other lumens, tissue and abnormalities and generate images and graphical representations therefrom.

[0076] Optionally, the workstation may be configured to: (i) select the automation element based on the verbal or touch command directly, via the tablet, or via the table mount; (ii) automatically identify a border of the vascular lumen imaged by the IVUS catheter; and (iii) provide a graphical representation of the vascular lumen border to be displayed as an overlay on the IVUS image. In several embodiments, the workstation may also be configured to: (i) calculate one or more confidence values associated with one or more sections of the vascular lumen border; and (ii) provide the graphical representation of the vascular lumen border to be displayed as the overlay on the IVUS image, wherein the graphical representation of the vascular lumen border is divided into the one or more sections of the vascular lumen and the one or more sections are color-coded based on the one or more confidence values associated with each of the one or more sections. In several embodiments, the workstation may also be configured to: (i) receive an input from a user, (ii) identify a custom border of the vascular lumen based on the identified border and the input from the user; and (iii) update the graphical representation, the graphical representation of the vascular lumen border comprising the custom border. The workstation may be optionally configured to: (i) receive, via the tablet mount, the verbal command; (ii) determine whether the verbal command comprises a wake command; and (iii) provide a notification to the user in response to the user inresponse to determining that the verbal command comprises the wake command, wherein the notification indicates to the user that the system is in a wake mode. Optionally, the workstation may also be configured to: (i) receive, via the tablet mount, a second verbal command; and (ii) determine one or more of a grammar context and a social cue context of the other verbal command based on the determination that the first verbal command comprised a wake word. In several embodiments, the tablet mount further includes a camera. In several embodiments, the tablet mount may be substituted by the tablet. In several embodiments, the workstation and / or tablet (i) is configured to receive one or more IVUS image labels associated with one or more IVUS images from a user via a verbal command or a touch input, (ii) is configured to receive a verbal command comprising the one or more IVUS image labels, (iii) has one or more IVUS image labels comprise one or more labels associated with a procedure type, and / or (iv) is configured to store one or more sets of procedure-specific labels. In some embodiments, instead of a vascular lumen using IVUS, the workstation and / or tablet is used with other lumens, tissue and abnormalities that do not necessarily use IVUS but rather use the other imaging components as described herein.

[0077] In various embodiments, the patient chassis includes a bed, and the mounting surface includes a bed rail. In several embodiments, the workstation is removably attachable to a mobile cart, wherein the mobile cart comprises a plurality of wheels, a power connector, one or more component holders, a handle, and a storage compartment. The IVUS catheter may optionally include an imaging core, a flexible elongate member, and an imaging lumen of that is filled with an acoustic coupling medium and sealed. The imaging core may include a rotating single element ultrasound transducer. Optionally, the rotating single element transducer may be configured to acquire a plurality of image lines by a pulse-echo emission and a pulse-echo reception while the rotating single element ultrasound transducer is spinning about a length axis of a driveshaft. In several embodiments, the rotating single element transducer may be configured to collect a plurality of image lines in a high-fidelity format without loss. One or more processors may optionally be configured to store the plurality of images lines in a computer-readable memory in a custom format configured to maintain the high-fidelity format. In several embodiments, the IVUS catheter further may include a rigid connector hub, and the catheter interface module may include an interface configured to receive the rigid connector hub.

[0078] An elongate flexible member of the IVUS catheter may have a length between eight feet and nine feet is some embodiments. The elongate flexible member may include a working portion. The working portion may have a length between 100 centimeters and 200 centimeters. Optionally, an elongate member further may include a 5F sheath or 8F sheath. In several embodiments, an elongate member further includes a guidewire with an outer diameter between 0.01 inches and 0.04 inches. The motor may optionally rotate an imaging core at a rate in a range of 1500 - 4000 rpm. Optionally, the tablet may be configured to be placed in wireless communication with the workstation. The tablet may optionally be configured to execute a user interface. In several embodiments, the tablet may be configured to receive the verbal command from the user. Optionally, the tablet may be configured to: (i) determine a grammar context and a social cue context associated with the at verbalcommand; and (ii) transmit the at least one command, the grammar context of the verbal command, and the social cue context of the at least one command to the workstation. In several embodiments, the tablet may be configured to (i) determine a grammar context and a social cue context associated with the verbal command represent a valid interaction; (ii) transmit at least one command to the workstation, (iii) determine if the verbal command is one of: a default verbal command or a known custom verbal command, and / or (iv) determine a social cue context based on whether a period of silence occurred prior to receiving the voice command. The tablet may optionally be configured to transmit the verbal command to the workstation, and one or more processors may optionally be configured to: (i) determine a grammar context and a social cue context associated with the verbal command; and (ii) generate the IVUS image based on the verbal command. In several embodiments, the tablet may include at least one of the group consisting of: a touchscreen, a microphone, a camera. The IVUS system may optionally be configured to capture a face of the user via a camera and authenticate the user based on one or more facial features. The tablet may optionally be configured to receive a voice input from a user and transmit the voice input to the workstation. In various embodiments, transmitting verbal commands to workstation may be direct to the workstation, via a tablet receiving voice input, via the tablet mount receiving voice input, via the tablet mount sending voice input to the tablet, and / or the tablet sending voice commands to the workstation.

[0079] In various embodiments, the tablet may be configured to be connected to a power source during an IVUS procedure. In several embodiments, the workstation includes an ultrasound system control board. The ultrasound system control board may optionally be configured to provide high speed processing, high dynamic range signal capacity, and high-end signal processing support precise control of transmit waveforms and receive processing to maximum spatial resolution, temporal resolution, and image contrast for superior image interpretation. In several embodiments, a non-transitory computer-readable memory may be configured to store information associated with the IVUS catheter. The information associated with the IVUS catheter may include catheter identification information, usage data, and calibration data. Optionally, the catheter interface module is configured to read the non-transitory memory of the rigid connector hub and transmit the custom system configuration to the workstation, wherein the workstation and / or table is configured to initialize the custom system configuration. Optionally, instructions may cause the one or more processors to perform edge-based machine learning computations associated with one or more of a plurality of image lines or the IVUS image. The workstation may optionally be configured for image analysis using an artificial intelligence algorithm to identify a vessel border. In several embodiments, the workstation may be configured for image analysis using an artificial intelligence algorithm to identify a plaque in a peripheral vascular system. Optionally, instructions may cause one or more processors to detect a vessel border. In several embodiments, the IVUS catheter is configured for peripheral vascular imaging. The IVUS catheter may optionally be the IVUS configured for coronary vascular imaging. Optionally, instructions may cause one or more processors to perform a multi-channel processing of a plurality of image lines. The multi-channel processing may optionally provide real time processing and image processing forthe display of human interpretable images, while also processing for automated, computer based, image interpretation. In several embodiments, the IVUS system may also include at least one cloud server configured to receive and store IVUS procedure data. The IVUS procedure data can include one or more of: a plurality of image lines, the IVUS image, catheter identification information, catheter usage information, and catheter calibration information.

[0080] In various embodiments, an intravascular ultrasound imaging system may include one or more of the following features: (i) the workstation and / or tablet is configured to determine a degradation level of a bioresorbable stent, (ii) the workstation and / or tablet is configured to automatically create a procedure report; and provide the procedure report to be displayed on one or more of: the tablet and a display of the workstation, (iii) is configured to provide one or more images to be displayed on one or more of the tablet and a display of the workstation, (iv) one or more images further comprise one or more of: at least one measurement, at least one label, and at least one bookmark, (v) a display / tablet is configured to provide the one or more images in a grid, optionally wherein the grid is one of: a 1 image by 1 image grid, a 2 image by 2 image grid, a 4 image by 4 image grid, and a 4 image by 2 image grid, (vi) is configured to determine a blood flow rate adjacent to the catheter based speckle information in two or more sequential image, (vi) the workstation is configured to automatically configure a local network, search for one or more of the tablet and the tablet mount using an interrogation protocol, wherein tablet and the tablet mount are configured to execute a network configuration client; and / or connect one or more of the tablet and the tablet mount to the local network. The catheter may be an IVUS catheter or adapted for another bodily lumen.

[0081] In various embodiments, one or more of the workstation and the tablet are configured (i) to execute a user interface, (ii) wherein the user interface is optionally synchronized across a plurality of displays, the plurality of displays comprising the tablet and a workstation display, (iii) instruct the IVUS catheter to capture a plurality of IVUS images during a pullback maneuver; (iv) automatically detect one or more vessel dissections in the plurality of IVUS images; and / or (v) automatically provide a graphical representation of the one or more vessel dissections, the graphical representation comprising one or more highlighted regions corresponding with the one or more vessel dissections. The graphical representation of the one or more vessel dissections may optionally include one or more of: a two-dimensional timeline or a three-dimensional rendering of the vessel captured during the pullback maneuver.In several embodiments, an imaging system (such as IVUS imaging system) is provided that includes (i) an IVUS catheter comprising: (i) a flexible elongate member comprising an imaging lumen and an imaging core disposed at a distal end of a driveshaft within the imaging lumen of the flexible elongate member; (ii) a catheter interface module comprising a motor, the motor configured to be mechanically connected to the driveshaft to rotate the imaging core; (iii) a tablet configured to receive at least one input from a user; (iv) a tablet mount configured for removable mechanical connection to the tablet and to the one or more mounting surfaces on the patient chassis, wherein the tablet mount is configured to connect a tablet power source to the tablet, whereinthe tablet mount comprises one or more microphones, wherein the one or more microphones is configured to receive a verbal command from a voice of the user; (v) a workstation configured to be placed in indirect or direct communication with the one or more microphones on the tablet mount, the tablet, the catheter interface module, and the IVUS catheter. The workstation can include a non-transitory computer-readable medium storing instructions thereon, wherein the instructions can be executed by the workstation to process a command from the user. The command may include one or more of a verbal command, a touch command, a gesture command, etc. A verbal command may be received by the one or more microphones on the tablet mount. A touch command may be received by the tablet, e.g., a touch screen command by the user at the tablet. The instructions can cause causing the processors of the workstation to instruct the motor to rotate the imaging core; instruct the imaging core to capture a plurality of image lines; process the plurality of image lines to generate an IVUS image; and / or provide the IVUS image to be displayed on the tablet in real time. In some embodiments, instead of a vascular lumen using IVUS, the imaging system is used with other lumens, tissue and abnormalities that do not necessarily use IVUS but rather use the other imaging components as described herein.

[0082] Optionally, the tablet mount may be connected to an articulating mount, and the articulating mount may include one or more articulator arms and a joint, wherein the joint is configured to lock, unlock, and reposition a position of the one or more articulator arms. In several embodiments, the patient chassis includes a bed. The tablet mount may optionally be repositioned on the one or more mounting surfaces on the patient chassis. Optionally, the workstation may be removably attachable to a mobile cart. The mobile cart can include a plurality of wheels, a power connector (e.g., on the cart or on a workstation on the cart), one or more component holders, a handle, and / or a storage compartment, wherein the mobile cart further comprises a display monitor with a screen in a range of 12 – 36 inches. In several embodiments, the lumen of the flexible elongate member may be filled with an acoustic coupling medium and sealed. Optionally, the imaging core can include a rotating single element ultrasound transducer. The rotating single element transducer may be configured to acquire the plurality of image lines by a pulse-echo emission and a pulse-echo reception while the rotating single element ultrasound transducer is spinning about a length axis of the driveshaft. In several embodiments, the IVUS catheter may include a rigid connector hub, and the catheter interface module can include an interface configured to receive the rigid connector hub.

[0083] Optionally, the elongate flexible member may have a length between eight feet and nine feet. The elongate member further can optionally include a 5F sheath or 8F sheath. In several embodiments, the elongate member may include a guidewire with an outer diameter between 0.01 inches and 0.04 inches. Optionally, the motor may be configured to rotate the imaging core at a rate in a range of 1500 - 4000 rpm. In several embodiments, the tablet may be configured to be placed in wireless communication with the workstation. The tablet may optionally be configured to execute a user interface. The tablet may receive the verbal command from the user. The tablet may optionally include: a touchscreen, a microphone, and at least one audio outputdevice. Optionally, the tablet may be configured to be connected to a power source during an IVUS procedure. In several embodiments, the workstation includes an ultrasound system control board. The non-transitory computer- readable memory may optionally be configured to store information associated with the IVUS catheter. Optionally, the instructions may cause the one or more processors to perform edge-based machine learning computations associated with one or more of the plurality of image lines or the IVUS image. In several embodiments, the instructions may further cause the one or more processors to detect a vessel border. Optionally, the workstation may be configured for image analysis using an artificial intelligence algorithm to identify a vessel border in a peripheral vascular system. In several embodiments, the instructions may further cause the one or more processors to perform a multi-channel processing of the plurality of image lines. The workstation may optionally be configured for image analysis using an artificial intelligence algorithm to identify blood, a plaque, and / or thrombus in a peripheral vascular system. The workstation may optionally be configured for image analysis using an artificial intelligence algorithm to identify an irregularity (e.g., a plaque, thrombus, dissection, etc.) in a peripheral vascular system.

[0084] In several embodiments, an imaging system (e.g., IVUS imaging system) is provided that comprises: (i) an IVUS catheter; (ii) a tablet configured to receive at least one input from a user; and (iii) a tablet mount configured for removable mechanical connection to the tablet and to one or more mounting surfaces on a patient chassis, wherein the tablet mount is configured to connect a tablet power source to the tablet, wherein the tablet mount comprises one or more microphones, wherein the one or more microphones is configured to receive a verbal command from a voice of the user.

[0085] In several embodiments, methods for imaging (e.g., IVUS imaging) comprise: (i) providing an IVUS catheter, the IVUS catheter comprising a flexible elongate member comprising a lumen and an imaging core disposed at a distal end of a driveshaft within the lumen of the flexible elongate member; (ii) providing a catheter interface module, the catheter interface module comprising a motor configured to be mechanically connected to the driveshaft to rotate the imaging core; (iii) connecting the catheter interface module to one or more mounting surfaces on a patient chassis using a catheter interface module mount, the catheter interface module mount configured to connect a catheter interface module power source to the catheter interface module; (iv) providing a tablet, the tablet configured to receive at least one input from a user; (v) providing a tablet mount comprising one or more microphones, the tablet mount configured to connect a tablet power source to the tablet and receive a verbal command from a voice of the user via the one or more microphones; (vi) removably and mechanically connecting the tablet to the one or more mounting surfaces on the patient chassis using the tablet mount; (vii) providing a workstation configured to be placed in communication with the one or more microphones on the tablet mount (directly or via the tablet), an interactive display, the catheter interface module, and the IVUS catheter, wherein the workstation comprises a non-transitory computer readable memory and one or more processors; (viii) rotating, via the motor, the imaging core of the IVUS catheter; (ix) capturing, via the imaging core,a plurality of images lines; (x) generating an IVUS image based on the plurality of image lines; and / or (xi) providing the IVUS image to be display on the tablet in real time. The system may include an IVUS catheter or be adapted for another bodily lumen.

[0086] The one or more microphones may include one or more directional microphones in several embodiments. Methods may also include: (i) identifying, via the tablet mount, a direction of the verbal command; (ii) determining, via the tablet mount, the direction of the verbal command is toward the tablet or away from the tablet; and (iii) transmitting the verbal command to the workstation in response to determining the direction of the verbal command is toward the tablet mount. The methods may optionally include determining, via the tablet mount, a speaker who generated the verbal command; and transmitting the verbal command to the workstation in response to determining that the speaker was the user. Optionally, the methods can include filtering, via the tablet mount, one or more signal detected by the one or more microphones based on one or more of: a frequency, a variance, and an amplitude of the one or more signals detected by the one or more microphones. The methods may optionally include updating, via the workstation, a user interface based on the verbal command. In several embodiments, the methods may include determining, via the workstation, tablet, or tablet mount, a grammar context, and a social cue context of the verbal command.

[0087] Optionally, the methods may include initiating, via the workstation, at least one voice interaction with an element of the user interface based on the verbal command. The element of the user interface may include at least one of: a live image element, a label element, a screen capture element, a length measurement element, an area measurement element, an automation element, a brightness control element, a zoom control element, a measurement summary element, a IVUS image loop element, and a timeline element. In several embodiments, the methods can include: (i) selecting, via the workstation, the automation element based on the verbal command; (ii) automatically calculating, via the workstation, one or more measurements of a lumen imaged by the IVUS catheter, the one or more measurements comprising: a maximum diameter of a lumen imaged by the IVUS catheter, a minimum diameter of the lumen, and an average diameter of the lumen; and (iii) providing an IVUS image and the one or more measurements to be displayed. The methods may optionally include: (i) selecting, via the workstation, the automation element based on the verbal command; (ii) automatically identifying, via the workstation, one or more irregularities in the lumen imaged by the IVUS catheter; and (iii) providing a graphical representation of the one or more irregularities to be displayed as an overlay on the IVUS image. In several embodiments, the methods may also include calculating, via the workstation, at least one property of the one or more irregularities; and providing the graphical representation of the one or more irregularities to be displayed, the graphical representation further comprising the at least one property. The at least one property may include one or more of: at least one dimension and an irregularity type.

[0088] Optionally, the methods may include: (i) selecting, via the workstation, the automation element based on the verbal command; (ii) automatically identifying, via the workstation, a border of the lumenimaged by the IVUS catheter; and (iii) providing a graphical representation of the lumen border to be displayed as an overlay on the IVUS image. In several embodiments, the methods can include: (i) calculating, via the workstation, one or more confidence values associated with one or more sections of the lumen border; and (ii) providing the graphical representation of the lumen border to be displayed as the overlay on the IVUS image, wherein the graphical representation of the lumen border is divided into the one or more sections of the lumen and the one or more sections are color-coded based on the one or more confidence values associated with each of the one or more sections. The methods may also include (i) receiving an input from a user, (ii) identifying a custom border of the lumen based on the identified border and the input from the user; and (iii) updating the graphical representation, the graphical representation of the lumen border comprising the custom border. Optionally, the methods may include: (i) receiving, via the tablet mount (e.g., directly with a microphone on the tablet mount, or indirectly via the tablet), the verbal command; (ii) determining, via the workstation, tablet, or tablet mount, whether the verbal command comprises a wake command; and (iii) providing a notification to the user in response to the user in response to determining that the verbal command comprises the wake command, wherein the notification indicates to the user that the system is in a wake mode. In one embodiment, audio speech recognition (ASR) can run on the tablet, workstation, or the tablet mount. The methods may optionally include receiving, via the tablet mount, a second verbal command; and determining, via the workstation, one or more of a grammar context and a social cue context of the other verbal command based on the determination that the first verbal command comprised a wake word.

[0089] Optionally, the tablet or tablet mount can include a camera. In several embodiments, the methods may include placing the catheter interface module outside of a sterile field. The catheter interface module mount may optionally include one or more articulator arms and a joint, wherein the joint is configured to lock, unlock, and reposition a position of the articulator arm. In several embodiments, the methods may include providing a workstation mount configured to provide a removable connection to the workstation. The workstation mount can include one or more articulator arms and a joint, wherein the joint is configured to lock, unlock, and reposition a position of the articulator arm. Optionally, the methods may include repositioning the workstation mount on the one or more mounting surfaces on the patient chassis. In several embodiments, the tablet mount can include one or more articulator arms and a joint, wherein the joint is configured to lock, unlock, and reposition a position of the articulator arm. The patient chassis may optionally include a bed. Optionally, the catheter interface module can mount on the one or more mounting surfaces on the patient chassis. In several embodiments, the methods include repositioning the tablet mount on the one or more mounting surfaces on the patient chassis. The methods may optionally include providing a mobile cart comprising a plurality of wheels, a power connector, one or more component holders, a handle, and a storage compartment; and removably connecting the workstation to the mobile cart.

[0090] Optionally, the mobile cart can include a display monitor with a screen in a range of 12 – 36 inches. The display monitor may be a touch screen. In several embodiments, the methods may include filling the lumen of the elongate member with an acoustic coupling medium and sealing the lumen. The imaging core may optionally include a rotating single element ultrasound transducer. Optionally, the methods can include acquiring, via the rotating single element transducer, the plurality of image lines by a pulse echo emission and a pulse-echo reception while the rotating single element transducer is spinning about a length axis of the driveshaft. In several embodiments, the methods include collecting, via the rotating single element transducer, the plurality of image lines in a high-fidelity format without loss. The methods may optionally include storing the plurality of images lines in the non-transitory computer readable memory of the workstation in a custom format configured to maintain the high-fidelity format.

[0091] Optionally, the IVUS catheter can include a rigid connector hub, and wherein the catheter interface module comprises an interface configured to receive the rigid connector hub. In several embodiments, the elongate flexible member may have a length between eight feet and nine feet. The elongate flexible member may optionally include a working portion comprising a length between 100 centimeters and 200 centimeters. In several embodiments, the elongate member further includes a 5F sheath or 8F sheath. Optionally, the elongate member may include a guidewire with an outer diameter between 0.01 inches and 0.04 inches. The methods may optionally include rotating the imaging core, via the motor, at a rate in a range of 1500 - 4000 rpm. Optionally, the methods may include placing the tablet in wireless communication with the workstation. In several embodiments, the methods include providing a user interface executed by the tablet. The user interface may be provided to one or more tablets and a display monitor of the workstation. The user interface may be synchronized across the one or more tablets and / or displays. The tablet may optionally be configured to receive a verbal command from the user and optionally communicate commands to the workstation. Optionally, the methods may include determining a grammar context and a social cue context associated with the verbal command. In several embodiments, the methods include generating the IVUS image based on the verbal command. The tablet may optionally include at least one the group consisting of: a touchscreen, a microphone, a speaker, and a camera.

[0092] In several embodiments, a method for classifying tissue type or abnormality for one or more locations of interest in a vessel or other lumen / region of a patient includes: receiving ultrasound image data of the region (e.g., from a vessel intravascularly or other lumen) of the patient; extracting patient-specific vessel / lumen geometry of the patient from the ultrasound image data; extracting geometric features from the patient-specific geometry of the patient; and / or classifying different types of tissues or abnormality for one or more locations of interest in the vessel / lumen based on the extracted geometric features using a trained machine-learning based model trained based on ultrasound images obtained from ultrasound catheters operating at different frequencies and based on ultrasound images of multiple different types of vessels (or other lumens / tissue).

[0093] In several embodiments, a computer-implemented method of assessing a vessel of a patient includes: receiving intravascular ultrasound image data of the vessel of the patient; extracting information from the intravascular ultrasound image data of the vessel of the patient; storing the information in memory; and / or classifying different types of tissue for one or more locations of interest in the vessel based on the extracted and stored information using a trained machine-learning based model that is trained based on intravascular ultrasound images obtained from intravascular ultrasound catheters operating at different frequencies and based on intravascular ultrasound images of multiple different types of vessels.

[0094] The methods may optionally include: (i) types of tissue or abnormalities that are selected from the group consisting of: intima, media, adventitia, lumen, plaque, and calcium, (ii) generating an output for display on a graphical user interface that indicates the different types of tissue, (iii) different types of tissue are displayed in different colors, (iv) generating a confidence measure associated with the classifying, (v) outputting the confidence measure on a display of a graphical user interface, (vi) confidence measure is a global confidence measure or a local confidence measure, and / or (vii) the geometric features include a cross-sectional measurement, a thickness, and / or a length.

[0095] In several embodiments, a computer-implemented method of assessing a vessel of a patient includes: receiving one or more intravascular ultrasound images of the vessel of the patient; extracting data from the one or more intravascular ultrasound images; storing the data in memory; performing a vessel feature detection task on the extracted and stored data using a machine learning based model trained to detect at least a first vessel feature in intravascular ultrasound image data, wherein performing the vessel feature detection task comprises generating an automated output associated with the first vessel feature; and / or utilizing the automated output associated with the first vessel feature, performing a tissue classification task using a machine learning model trained to classify tissue in the one or more intravascular ultrasound images, wherein performing the tissue classification task comprises generating an automated result of the tissue classification task.

[0096] The method may include: (i) extracted data that includes amplitude and phase data, (ii) the first vessel feature is a lumen boundary and the vessel feature detection task is detection of the lumen boundary, (iii) automated output associated with the first vessel feature that is graphical output of the lumen boundary, (iv) the tissue classification task includes classifying plaque, calcium, a dissection and / or a thrombus, (v) the tissue classification task includes identification of a guidewire or medical device in the one or more intravascular ultrasound images, (vi) classifying the plaque or calcium that includes generating a qualitative or quantitative assessment of the plaque or calcium, (vii) outputting the automated result on a display, (viii) the automated result indicates different types of tissue based on the tissue classification, and / or (ix) the indication is provided using different colors.

[0097] In several embodiments, a computer-implemented method of training a neural network for tissue type characterization within intravascular ultrasound images using a disparate-source training approachincludes: receiving multiple sets of digital intravascular ultrasound images of different types of vessels and obtained using multiple different intravascular ultrasound catheters operating at different imaging frequencies; applying one or more transformations to each digital intravascular ultrasound image including geometry-based data augmentation and intensity-based data augmentation to create a modified set of digital intravascular ultrasound images; creating a first training set comprising the received multiple sets of digital intravascular ultrasound images and the modified set of digital intravascular ultrasound images, and a first set of unmodified digital intravascular ultrasound images; training the neural network in a first stage using the first training set; creating a second training set for a second stage of training comprising the first training set and a second set of unmodified digital intravascular ultrasound images; and / or training the neural network in the second stage using the second training set. Optionally, the different types of vessels may include coronary vessels, peripheral vessels, arteries, and / or veins. The multiple different intravascular ultrasound catheters may be manufactured by different manufacturers.

[0098] In several embodiments, the imaging system is configured for use in a blood vessel, in a bodily lumen other than a blood vessel, and / or in tissue located outside a lumen.

[0099] In several embodiments, the devices, systems and methods may use artificial intelligence (AI) to determine patient eligibility for further intervention and additionally use of the system and AI to reduce risk that patient receives unnecessary further interventions. BRIEF DESCRIPTION OF THE DRAWINGS

[0100] The following drawings are for illustrative purposes only and show non-limiting embodiments. Features from different figures may be combined in several embodiments.

[0101] Fig.1 illustrates an IVUS system according to one embodiment.

[0102] Fig.2 illustrates an IVUS system according to one embodiment.

[0103] Fig.3A illustrates a tablet mount according to one embodiment.

[0104] Fig. 3B illustrates an enlarged view of the tablet mount with one or more microphones according to Fig.3A.

[0105] Fig.4A illustrates a rear view of a tablet mount with one or more levers and a DC power connector according to Fig.3A.

[0106] Fig.4B illustrates a cutaway view of a tablet mount with one or more levers and internal wire routing according to Fig.3A.

[0107] Fig.5 illustrates the electronic components of a tablet mount according to one embodiment.

[0108] Fig.6 illustrates the electronic components of a tablet mount according to one embodiment.

[0109] Fig.7 illustrates a mount according to one embodiment.

[0110] Fig.8 illustrates a mount according to one embodiment.

[0111] Fig.9A illustrates a mobile cart according to one embodiment.

[0112] Fig.9B illustrates a mobile cart according to one embodiment.

[0113] Fig.10A illustrates a mobile cart according to one embodiment.

[0114] Fig.10B illustrates a bed rail mount according to one embodiment.

[0115] Fig.10C illustrates a tablet according to one embodiment.

[0116] Fig.11A illustrates a tablet mount according to one embodiment.

[0117] Fig.11B illustrates a tablet mount according to one embodiment.

[0118] Fig.11C illustrates a tablet mount according to one embodiment.

[0119] Fig.12A illustrates an imaging interface according to one embodiment.

[0120] Fig.12B illustrates an imaging interface according to one embodiment.

[0121] Fig.13A illustrates a measurement interface according to one embodiment.

[0122] Fig.13B illustrates a measurement interface according to one embodiment.

[0123] Fig.13C illustrates a measurement interface according to one embodiment.

[0124] Fig.14A illustrates a summary interface according to one embodiment.

[0125] Fig.14B illustrates a summary interface according to one embodiment.

[0126] Fig.15 illustrates a multi-channel process according to one embodiment.

[0127] Fig.16A illustrates a plurality of data channels according to one embodiment.

[0128] Fig.16B illustrates a plurality of data processing pipeline according to one embodiment.

[0129] Fig.17 illustrates a multi-channel processing according to one embodiment.

[0130] Fig.18 illustrates a process for receiving and processing a voice command according to one embodiment.

[0131] Fig.19 illustrates a process for receiving and processing a voice command according to one embodiment.

[0132] Fig.20 illustrates a process for vessel border detection according to one embodiment.

[0133] Fig.21 illustrates a plurality of overlays of an IVUS image according to one embodiment.

[0134] Fig.22 illustrates a process for lifecycle management of an IVUS image according to one embodiment.

[0135] Figs. 23A, 23B, 23C and 23D illustrate user interface layouts according to some embodiments.

[0136] Fig.24A illustrates a 2D cross-sectional IVUS image according to an embodiment.

[0137] Fig.24B illustrates an angiographic image captured during an IVUS procedure according to an embodiment.

[0138] Fig.24C illustrates a 3D reconstruction image according to some embodiments.

[0139] Fig.25 illustrates an IVUS system set up protocol according to some embodiments.

[0140] Fig.26 illustrates an IVUS system according to some embodiments.

[0141] Fig.27 illustrates a workstation according to some embodiments.

[0142] Fig.28A illustrates a catheter interface module (CIM) according to some embodiments.

[0143] Figs.28B – 28F illustrate a catheter interface module (CIM) with a clamp and lever handle according to some embodiments.

[0144] Fig.29 illustrates a system with a catheter, catheter interface module (CIM), workstation, and tablet according to some embodiments.

[0145] Fig.30 illustrates a method for automatic assessment of a vessel that includes application of nested models or daisy-chained models utilizing the multi-channel processing architecture according to some embodiments.

[0146] Fig.31 illustrates a computer-implemented method of training a neural network for tissue type characterization within intravascular ultrasound images using a disparate-source training approach according to some embodiments. DETAILED DESCRIPTION

[0147] According to several embodiments, the systems and methods described herein are directed towards improved IVUS systems. The IVUS systems provide a more user-friendly experience for clinicians directing the IVUS treatment and higher quality IVUS images. For example, using several embodiments described herein, the IVUS system can be set up and used more efficiently, taking less time and personnel. In several embodiments, the IVUS system is configured for optimized peripheral vascular procedures (including, e.g., procedures with carotid, subclavian, pulmonary, aortic (abdominal and / or thoracic), renal, iliac (arterial or venous), femoral popliteal (femoropopliteal, fem-pop) bypass, infrapopliteal, arteriovenous (AV) fistula, femoral, popliteal, and tibial vasculature, vessels, arteries, veins, and capillaries). In several embodiments, the IVUS system is configured for optimized peripheral vascular procedures and is not configured for coronary vascular procedures. In several embodiments, the IVUS system is configured for optimized coronary vascular procedures. In some embodiments, the IVUS system 100 may include more or fewer components. The actions may be performed by different components of the IVUS system 100 according to different embodiments, and in some cases, actions may be performed by more than one component.

[0148] With respect to pulmonary procedures for example, in some embodiments, the systems described herein are used for diagnostic, therapeutic pulmonary applications, such as endobronchial ultrasound, bronchoscopy, thoracoscopy, pleuroscopy, COPD diagnosis and treatment, video-assisted thoracic surgery (VATS), echocardiograms, pulmonary function tests, and diagnosis and minimally invasive treatment of lung and respiratory disorders. Nasal, sinus, throat, and tracheal imaging (and optional intervention) may be performed according to several embodiments.

[0149] In several embodiments, the IVUS system is configured for neurovascular procedures (including but not limited to cerebral vessels). In several embodiments, the IVUS system is configured forintravascular ultrasound-guided thrombectomy, including but not limited to mechanical thrombectomy. In some embodiments, the IVUS system is configured for ultrasound-guided pulmonary embolectomy. In several embodiments, simultaneous, real-time IVUS guidance is provided for procedures such as thrombectomy / embolectomy, stent placement, clot aspiration, other coronary or neurovascular procedures, etc. Neurovascular, coronary and pulmonary clots are treated in several embodiments using the ultrasound imaging devices and methods disclosed herein together with (either integrated or separate) clot treatment devices. With respect to diagnostic and therapeutic applications in a vessel, for example in the neurovascular space, in some embodiments, the systems described herein are used for diagnostic, therapeutic brain applications. For example, several embodiments may be used to image cerebral vessels to image and thereby facilitate diagnosis and / or treatment of thrombus, and / or other tissue damage and / or disease states. The small vessels surrounding the eye, whether neurovascular or ocular, may be well-suited for the enhanced visualization technologies described herein.

[0150] In some embodiments, the ultrasound imaging technologies described herein are used to visualize neuromodulation, such as nerve ablation, blocks, and stimulation. Such visualization may be helpful for confirming delivery of the neuromodulation (e.g., by heat, cryotherapy, chemical, radiofrequency, microwave, acoustic, etc.) to the desired target nerve(s) in a vessel, other lumen or region. This is turn may be used to increase the likelihood that the target nerve is treated, while preserving healthy nerves and other healthy tissue surrounding the target nerve. Visualization may be before, after and / or during neuromodulation and real-time visualization is provided in several aspects.

[0151] Although several embodiments described herein described IVUS, the technology described herein are also used for intraluminal imaging (other than intravascular). For example, several embodiments are used for imaging, diagnosing, and / or providing an image-guided intervention in the digestive tract (including but not limited to colonoscopy, endoscopy, etc.), esophagus, stomach, intestine, rectum, sinus (including ENT for example), , ureter (and other urological tissue), bladder, uterus, fallopian tubes, lungs, brain, etc. The systems and methods described herein may be used in conjunction with an endoscope rather than an IVUS catheter and support identification and diagnoses of gastrointestinal tumors, such as tumors in the intestines and / or biliary ducts. Similarly, the systems and methods described herein may be used to image a sinus cavity (or other ENT application, such as treatment for nose bleeds such as epistaxis) using imaging ultrasound, such as IVUS. ENT (ear, nose, throat) visualization are provided in several embodiments, as are ocular application to help image various eye structures. In various embodiments, IVUS uses ultrasound for imaging only (without therapy). In various embodiments, IVUS uses ultrasound for therapy only (without imaging). In various embodiments, IVUS uses ultrasound for both imaging and therapy. According to several embodiments, one or more imaging technologies as described herein can be combined on the same catheter as one or more therapy elements, such as an integrated ultrasound imaging element located at or near the tip of (or otherwise along) a thrombectomydevice. The thrombectomy device can also be a separate device that is delivered before, during or after the imaging device. Thrombectomy devices can be mechanical clot retrieval devices, clot aspiration devices, or a combination of clot retrieval and aspiration. Neurovascular, coronary and pulmonary clots are treated in several embodiments using the ultrasound imaging devices and methods disclosed herein together with (either integrated or separate) clot treatment devices. The clot treatment device can also include for example non-mechanical devices such as lytic or other drug delivery devices and energy delivery devices to disrupt / remove the clot or otherwise restore blood flow. Combinations of two, three or more therapies combined with the IVUS imaging technologies described herein are also provided (for example, ultrasonic or laser clot disruption with a lytic agent). The integrated IVUS and therapy catheter or probe can also be used, according to several embodiments, for restoring blood flow that is not caused by a clot.

[0152] In several embodiments, the technologies described herein, including the IVUS technologies for example, are used with other medical imaging systems (such as cardiac catheterization lab systems), to provide an integrated healthcare portfolio for cardiologists. An integrated or otherwise coordinated platform, in several embodiments, can improve workflow between various imaging systems, including for example, x-ray systems. In one embodiment, stent placement and other procedures are optimized using the IVUS technology described herein together with x-ray, external ultrasound and / or other non-IVUS technology. According to several embodiments, cardiac imaging as described herein is used in intracardiac imaging (e.g., may be used instead of intracardiac echocardiography (ICE) procedures). The architectures, AI / ML technologies, edge detection, voice control, plug and play, and other aspects may be advantageous and configured for intracardiac imaging (and in one embodiment may be used to supplement or improve ICE techniques). In some embodiments, features and / or dimensions of the catheter components described herein are adjusted for intracardiac delivery (e.g., in some cases larger than the dimensions for blood vessels). In some embodiments, cardiac imaging is used for one more of the following: guiding procedures such as ablation to treat arrythmias, septal defect closure, monitoring for pericardial effusion, evaluation of the inner surface of the heart and valves, transeptal catheterization, confirming balloon position, guide valve placement, and general cardiac monitoring during intervention.

[0153] In several embodiments, the IVUS technologies described herein are used with other catheter-based imaging procedures and / or non-catheter-based imaging procedures. Imaging procedures may include ultrasound, x-ray, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), PET-CT, fluoroscopy, endoscopy, angiography, optical coherence tomography, intravital microscopy, 2D imaging, 3D imaging, etc. Several embodiments described herein utilize synchronized operation, imaging, and / or measurements from two, three or more imaging modalities (e.g., ultrasound, X-ray (including radiography, fluoroscopy, angiography, venography, etc.), magnetic resonance, PET scans, optical imaging (e.g., optical coherence tomography, light, laser imaging), etc.). Multi-modality synergies between IVUS and one ormore additional imaging systems are achieved in several embodiments, including for example, enhanced visualization and image quality, decreased procedure time, increased precision in stent positioning and vessel measurements, improved workflow and reliability, and other benefits. Multi-modal systems including IVUS may be used, for example, to allow cardiologists to diagnose and / or treat vascular blockages and other defects that should, in turn, offer patients with improved cardiac outcomes, while reducing the overall cost burden to the healthcare system through efficient and effective integration with IVUS. A more robust image of vessel and organ structures (such as heart structure) can be obtained using various embodiments of the IVUS technologies described herein. In some embodiments, the ultrasound imaging techniques described herein can be used instead of other visualization and diagnostic devices. For example, several embodiments do not use radiation or dyes.

[0154] Fig.1 illustrates an IVUS system 100 according to one embodiment. The IVUS system 100 may be used to image and diagnose intravascular tissue. In various embodiments, the IVUS system 100 is configured for ease of setup and use. Identification of irregularities may be accomplished using the IVUS system 100. In addition to the identification of vascular irregularities, several embodiments herein are used to facilitate relevant measurements and preparation for deploying stents and / or balloons, perform thrombectomies, perform atherectomies, and are useful for planning of treatment by medical practitioners, e.g., physicians, surgeons, and / or medical technicians in various fields, such as vascular surgery, interventional cardiology, and / or radiology throughout the body from the heart and its associated coronary vasculature to the peripheral vasculature. In various embodiments, the IVUS system 100 can include any one or more components described in U.S. Patent Serial No. 63 / 459,312 entitled Systems and Methods for Flush-Less Intravascular Ultrasound Catheter, No. 63 / 497,962 entitled Spinning Single Element Ultrasound Transducer and Focusing Methods, and / or No. 63 / 531,266 entitled Systems and Methods of Manually Assisted Pullback for Spatial Alignment Lengthwise Measurements in Intravascular Ultrasound Imaging, all herein incorporated by reference.

[0155] In several embodiments, the technology described herein incorporates technology described in U.S. Patent Serial No. 63 / 459,312 entitled Systems and Methods for Flush-Less Intravascular Ultrasound Catheter, including but not limited to paragraphs 7-8, 62, 69, 71, 76-77, 80-81, and 112 bodily incorporated herein: Several embodiments provide a rigid proximal connector hub with a seal (e.g., a flexible seal, wherein flexible in some embodiments is elastic, malleable, bendable, modifiable, adjustable, accommodating, adaptable, pliable, supple, pliant, and / or resilient) as part of a catheter to support an encapsulated medium while allowing an inner imaging core to rotate without leaks of the medium and to prevent air ingress into the catheter lumen. A flexible seal surrounds a driveshaft (e.g., drive cable, drive coil, drivetrain, drive actuator) of the rotating imaging core inside a rigid proximal connector hub holding the medium inside the lumen connected to the hub while the core rotates. The circular seal may be compressed onto the driveshaft with sufficient force to prevent leaks while still allowing a motor (e.g., connected to an imaging console) to rotate the inner imaging core at rates to support high imaging frame rates. Example materials include elastic polymers like nitrile, ethylene propylenerubber, and fluorocarbons and similar materials. Two seal housings may be arranged to fix the flexible seal between the connector hub and the rotating driveshaft. The surfaces of the two seal housings are precisely mated to ensure proper pressure is applied to the flexible seal allowing the driveshaft to rotate without too much friction and also preventing the medium from leaking proximally through the flexible seal. An adhesive may optionally be applied to the outer circumference of the flexible seal to prevent leaks around the flexible seal. The flexible seal may be assembled inside the rigid proximal connector hub to ensure a precise fit. In some embodiments, this is advantageous over placing a seal inside a flexible catheter or similar catheter body / lumen as the flexibility may contribute to medium leaks or air ingress during use. During normal operation in typical clinical environments the pressure differential on the two sides of a flexible seal is generally insignificant so there is little force to push the medium out or to pull air in. However, outside the clinical theatre, such as during product transport, the catheter may be subject to extreme temperature swings. When exposed to extreme drops in temperature, the coupling medium may change from a liquid to a solid state either increasing or decreasing the encapsulated medium volume and then returning back to a default volume after the extreme temperature exposure. This volume change typically requires some flexibility of the seal so air is not pulled into the inner lumen. Air that gets into the lumen may migrate to the distal transducer of the spinning imaging core and degrade image quality. The dual seal housings are preferred in one embodiment for precise assembly and sealing, however a single housing on the proximal side only may also be used. A fill port is included in the rigid proximal connector and is sealed after filling the catheter lumen with the medium, according to several embodiments. The fill port may be different shapes to facilitate the connection to the filling equipment. After filling the catheter lumen the fill port is closed off with a plug and / or adhesive to prevent any air ingress. A preferred fill port, in one embodiment, has the inlet most proximal, juxtaposed to the flexible seal to aid in purging all air bubbles during the fill process. Methods to seal the exit port after filling the lumen are also provided herein. A distal plug is attached to a removable wire in one embodiment. Removable wires include for example NiTi (nitinol), stainless steel, or other flexible wires. According to several embodiments, (i) the wire is fed through the lumen exiting the exit port leaving the distal plug loosely floating in the distal section of the lumen; (ii) the filling process is completed once all bubbles are removed from the lumen as air is purged from the exit port; and (iii) upon inspection of no air bubbles, the distal plug is bonded to the wall of the lumen either with a heating process that reflows the materials together and / or a small amount of adhesive is inserted into the exit port bonding the plug to the luminal walls. The wire may be removed easily from the plug after the distal plug is bonded to the catheter lumen. A colorant may be added to the medium before the filling process starts aiding inspection for leaks and identification of gas bubbles. The colorant adds optical contrast aiding in the identification of the medium and gas bubbles improving the manufacturing process. In one embodiment, the lumen is configured to receive rotational transducer and a driveshaft. The driveshaft mechanically couples the rotational transducer to an actuator. The lumen may be configured to receive a coupling medium. In various embodiments, the coupling medium is biocompatible, sterilizable, and / or acousticallycompatible. For example, the coupling medium may be polyethylene glycol (PEG), PEG with some fraction of water, water, saline, glycerin, and / or oil (e.g., natural, mineral, etc.), or a combination thereof. In various embodiments, the coupling medium does not include PEG, water, saline, glycerin, or oil. In various embodiments, the coupling medium is degassed prior to insertion into the lumen. In one embodiment, the coupling medium has a viscosity greater than water that reduces or eliminates non-uniform rotational distortion (NURD). In one embodiment, an elongate member that includes a lumen and a rapid exchange (RX) lumen according to one embodiment. In some embodiments, the elongate member comprises one or more housing layers. In some embodiments, the RX lumen at a distal tip that includes a distal plug. The lumen of the elongate member may receive a rotating transducer that is mechanically connected to a driveshaft. The lumen may also receive a coupling medium. The coupling medium may be a liquid or a gel. For example, the coupling medium may be polyethylene glycol (PEG), PEG with some fraction of water, water, saline, glycerin, natural oils, or a combination thereof. In various embodiments, the coupling medium has a density and speed of sound value that are similar to the catheter jacket material to prevent or reduce unwanted reflections from the medium / jacket interface and prevent or reduce refraction of the acoustic beam. PEG may be provided in a range of 5-90% (e.g., 5-10%, 10- 25%, 20-50%, 40-80%, and overlapping ranges therein). PEG may be provided in various low molecular weight grades of polyethylene glycol. PEG may be provided in various medium molecular weight grades of polyethylene glycol. PEG may be provided in various high molecular weight grades of polyethylene glycol. In one embodiment, an isometric view of a connector hub of one embodiment of an IVUS catheter system. In one embodiment, the connector hub is a rigid material with one or more flexible seals to support an encapsulated medium while allowing an imaging core and driveshaft to actuate via rotation and / or linear motion along the catheter axis without leaks of the medium and prevent air ingress into the catheter lumen with one or more seals and / or valves. In one embodiment, the flexible seal surrounds the driveshaft (extending though flexible seal and distally through the connector hub and into the lumen of the catheter) inside a rigid connector hub holding the medium inside the lumen while the imaging core rotates. In one embodiment, the flexible seal is a circular seal that is compressed onto the imaging core of the connector hub with sufficient force to prevent leaks while still allowing a motor or actuator in an imaging console to rotate the imaging core at rates to support high imaging frame rates. In various embodiments, the flexible seal is made of nitrile, nitrile rubber, nitrile butadiene rubber, Buna-N, acrylonitrile butadiene rubber, ethylene propylene rubber, ethylene propylene diene monomer rubber, fluorocarbons, fluoroelastomer, fluorine rubber, synthetic rubber polymer (such as Viton and others), silicone rubber, rubber derived from acrylonitrile, and similar materials. The connector hub is connected to a proximal connector of an IVUS catheter. In some embodiments, the connector hub is connected to the driveshaft of an imaging core. In one embodiment, the connector hub is integrated with the catheter body such that the connector hub forms the proximal end of the catheter body. In one embodiment, the connector hub is separate and distinct from the catheter body such that the connector hub is adjacent to, or near, a proximal end of the catheter body. In one embodiment,the connector hub comprises a medium fill port. The medium fill port is configured to connect to a source or reservoir of an acoustic coupling medium. The medium fill port may be configured for inserting the acoustic coupling medium through the connector hub and into the lumen of the elongate member of the IVUS catheter. The medium fill port is sealed after filling the catheter lumen with the medium. The medium fill port may be shaped to accommodate different connector geometries. The medium fill port may be disposed proximal to the distal interface and is distal to a flexible seal and the proximal interface. The position of the medium fill port may aid in purging all air bubbles during the fill process. In some embodiments, the medium fill port may be sealed with an adhesive and / or with a plug similar. In one embodiment, the fill port has the inlet most proximal, juxtaposed to the flexible seal to aid in purging all air bubbles during the fill process. In various embodiments, the connector hub includes one or more flexible seals. The flexible seal may surround the driveshaft inside a connector hub and seal a coupling medium inside a lumen of a catheter body while the core rotates. The flexible seal may be compressed onto the core with sufficient force to prevent leaks while still allowing an actuator of the console via the proximal interface to rotate the imaging core at rates to support high imaging frame rates. In some embodiments, the flexible seal may be assembled inside the connector hub to ensure a precise fit. The connector hub may include one, two, three or more flexible seals. In one embodiment, a distal end of an elongate member with an exit port configured for sealing after filling the catheter lumen with an acoustic coupling medium according to one embodiment. The elongate member includes a lumen, which includes a distal port. The lumen may be filled with a coupling medium, and the distal port may be sealed to reduce or eliminate air bubbles from the lumen, and to reduce or eliminate the need to flush the catheter lumen. In some embodiments, a distal plug may be attached to a removable wire. In one embodiment, the distal plug is a polymer material. In various embodiments, the distal plug may be made of Pebax (polyether block amide), nylon or other polymer materials such that bonding and / or thermally fusing the plug with the catheter body is effective. In some embodiments, the distal plug may be shaped to conform with the geometry of the distal port. The removable wire may be NiTi (nitinol), stainless steel, or another flexible material. The wire may be fed through the lumen from a proximal port at the proximal end towards the distal port. The wire is configured, in one embodiment, to exit the distal port, leaving the distal plug in the distal section of the lumen. As the filling process is completed, and once all bubbles are removed from the lumen, the distal plug may be bonded or adhered to the wall of the lumen. The distal plug may be drawn to the distal port by the wire such that the distal plug seals the distal port. In some embodiments, heat may be applied to the distal end of the elongate member, causing the distal plug to melt with and / or adhere to the wall of the lumen. In some embodiments, an adhesive may be inserted into the distal port, bonding the plug to the walls of the lumen. The wire may be removed from the plug after the distal plug is bonded to the lumen. In one embodiment, an acoustic coupling medium according to an embodiment in various embodiments of a catheter. In various embodiments, the acoustic coupling medium has similar acoustic properties to blood, is biocompatible, and is configured for filling the imaging lumen without (or by minimizing) bubbles within imaging plane and acoustic window. In variousembodiments, the acoustic coupling fluid may include up to 4 mL within the catheter (e.g., up to 3.5, 3.3, 3.1, 3.0, 2.8, 2.6, 2.4, 2.1, 1.9, 1.7, 1.5 mL and additional volumes therein). In one embodiment, the acoustic coupling medium is colored for ease of monitoring fill process and inspection for bubbles. Acoustically attractive media have density and speed of sound values that are similar to the catheter jacket material in several embodiments. Increased differences in density or speed of sound values between a medium and the catheter jacket may result in unwanted strong acoustic reflections and refracted sound pulses that degrade image quality. In several embodiments, media in several embodiments include one of polyethylene glycol (PEG), PEG with some fraction of water, water, saline, glycerin, and natural oils. The percentage of the non-PEG fraction may be 80 to 20% (e.g., 80%, 70%, 60%, 50%, 40%, 30%, 20% and overlapping values and ranges therein), and in certain embodiments a range of 50 to 30% (e.g., 50%, 45%, 44%, 43%, 42%, 41%, 40%, 39%, 38%, 37%, 35%, 35%, 30% and overlapping values and ranges therein) as the propensity for dissolved gases is lower for the latter, respectively.

[0156] In several embodiments, the technology described herein incorporates technology described in U.S. Patent Serial No. 63 / 497,962 entitled Spinning Single Element Ultrasound Transducer and Focusing Methods, including but not limited to paragraphs 38-39 and 44 bodily incorporated herein: In various embodiments, the angular or circumferential spatial resolution of IVUS imaging may be limited by the passive directivity function of the transducer given by the physics of diffraction. In various embodiments, the IVUS system has an imaging axial resolution of 10 – ^m (e.g., 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 125, 150, 175, 200, 225, 250, 275, 300, 325, 350, 375, 400, 425, 450, 475, 500 ^m and any values and ranges therein). In various embodiments, the IVUS system has an imaging lateral resolution of 10 – 500 ^m (e.g., 10, 20, 30, 40, 50, 60, 70, 80, 90, 100, 110, 125, 145, 150, 175, 185, 200, 215, 225, 250, 275, 290, 300, 325, 350, 375, 400, 425, 450, 475, 500 ^m and any values and ranges therein). In various embodiments, the IVUS system has an imaging lateral resolution of 2- 20 degrees (e.g., 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20 degrees and any values and ranges therein). In various embodiments, rotating or spinning a single ultrasound transducer about a single axis while imaging improves the clarity and sharpness of the imaging by 5-200% or more. In various embodiments, IVUS imaging resolution is improved 5 – 200% (e.g., 5, 10, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 85, 90, 95, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190, 200% and any values and ranges therein). In one embodiment, passive directivity involves no active means to control temporal delays or phases to actively focus or steer the ultrasound beam with a single transducer element, such as may be done with multi- element transducer arrays. The response of the imaging system to an isolated point target is called the point- spread function which can be collapsed to show only the lateral response when concerned specifically with that dimension. Certain factors that are under control of a device designer to optimize the lateral response characteristics of such a passively focused device include the imaging frequency (such as, for example, in the range of 1 – 90 MHz (e.g., 1-10, 10-15, 10-20, 10-25, 10-30, 10-40, 15-30, 15-35, 15-40, 15-50, 15-60, 15-70, 20- 30, 30-40, 40-50, 20 -25, 20-30, 20-40, 20-45, 20-50, 25-35, 25-40, 25-45, 25-50, 30-45, 30-50, 40-45, 45-50, 50-60, 50-70, 50-80, 55-75, 55-65, 60-70, 60-90, 70-80, 70-90 MHz and any values and ranges therein) In one embodiment, the device a frequency of 60 MHz. In several embodiments, lateral response characteristics of such a passively focused device are optimized, such as the acoustic aperture size (which is equal to the transducer element size for the case of a single element device), and potentially altering the fixed focusing characteristics by means of a physical lens, such as moving the focal length from “infinity” (which can be produced by a flat transducer) to a shallower depth. In various embodiments, fixed focus depths are in a range of 1 – 10 mm (e.g., 1.0, 1.1, 1.2, 1.3, 1.4, 1.5, 1.7, 1.8, 2.0, 2.4, 2.5, 2.7, 2.8, 2.9, 3.0,3.1, 3.2, 3.3, 3.4, 3.5, 3.7, 4.0, 4.5, 5.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.5, 9.0, 9.5, and 10.0 mm and any values or ranges therein. In one embodiment, the fixed focus depth is 2.5 mm – 3.5 mm (e.g., 2.5, 2.6, 2.7, 2.8, 2.9, 3.0, 3.1, 3.2, 3.3, 3.4, 3.5 mm and any values or ranges therein). In one embodiment, focus control of single element IVUS devices is constrained without a lens. An aperture with no lens has effectively an ideal focus performance at the depth of the near-field to far-field transition (called the “natural focus”) and beyond. In one embodiment, a single element IVUS relies on this natural focusing achieved with no lens. However, different materials are typically in the acoustic path, such as a polymer jacket which can act as a lens whether desired or not. Focus performance may be improved or degraded by the choice of geometry and material specifications of the device. In one embodiment, a high performance mechanical lens may be used, but is typically cost prohibitive. Standard rotational IVUS acoustic apertures are unfocussed, in the sense that there is no specific surface layer lens on the element to focus its directivity pattern. Standard devices are typically housed in polymer catheter sheath whose material properties will have an imperfect focusing effect by refraction through the standard catheter body. By judicious choice of material, the catheter body can shift the effective focal depth shallower, but it will come at the expense of an ideal deep focus. It is not possible to focus individual lines at more than one depth with a standard single element, and the near field typically suffers.

[0157] In several embodiments, the technology described herein incorporates technology described in U.S. Patent Serial No.63 / 531,266 entitled Systems and Methods of Manually Assisted Pullback for Spatial Alignment Lengthwise Measurements in Intravascular Ultrasound Imaging, including but not limited to paragraphs 5-7, 46, 49, 55, 60-66, 72-73, 76, 80, 83-84, 86-89, and 91 bodily incorporated herein: Several embodiments described herein provide systems and methods for determining a lengthwise, longitudinal position of a manually advanced ultrasound imaging catheter and measuring the length of a longitudinal, lengthwise movement of the ultrasound imaging catheter within a blood vessel, lumen, or other region. Manually assisted longitudinal, lengthwise pullback of an IVUS catheter may be implemented for spatial alignment measurements of tissue using IVUS imaging. In several embodiments, distance-based length measurements along an intraluminal axis of a patient are provided, such as measurements of vascular lengths using distance-based measurement along the vascular axis. Several embodiments provide relative position along an axial catheter dimension during sequentially acquired IVUS images within a human vessel using manual translation of a catheter with efficient clinical workflow. The position information allows for measurement among images acquired during translation withrespect to the axial dimension of a catheter without use of a bulky device in the sterile field to actuate movement of the catheter. Advantageously, several embodiments described herein do not require fully automated co- registration with another imaging modality such as fluoroscopy, in which a software algorithm tracks radio-opaque (RO) catheter marker(s) or a RO transducer throughout a continuous fluoroscopy recording. In several embodiments, systems and methods for IVUS based measurements do not require integration with another modality and reduces fluoroscopy exposure to the patient. Consistent operator-to-system or system-to-operator interaction may be more reliable than a software-based recognition system for RO markers where weak signals or poor-quality signals may limit accuracy. Co-registration with angiography is used, for example, in an attempt to shorten procedure time, decrease contrast use, and make practitioners more comfortable with IVUS. Described herein, are several embodiments that accomplish one or more of these benefits without co-registration. In some embodiments, use of the manual pullback helps correlate fiducial landmarks and waypoints within a patient’s body, including in complex cases, such as dimensional measurements of tissue damage, occlusions, lesions for treatment planning, such as atherectomy or stent placement (e.g., determining where in a vessel stenting will be begin and end). Although co-registration is still available with the systems and methods described herein, the ability to image without automated co-registration may allow for more flexibility to use different components (e.g. components that may be more readily available to physicians and / or components for which physicians already have a level of comfort). Increased speed of procedures, reduced cost of medical care, and better patient outcomes may be accomplished in many embodiments. According to several embodiments, the systems and methods described herein are directed towards improved intravascular ultrasound imaging and measurements. In several embodiments, the systems and methods provide vessel-wise distance measurements for a recording of IVUS images within a continuous human vessel using manual translation of a catheter. An IVUS recording that is made while withdrawing the catheter within a vessel is a workflow process that is referred to as a “pullback.” Augmenting a pullback with distance measurement information adds clinical value and workflow efficiently by facilitating length measurement between images in the pullback. In several embodiments, IVUS imaging is used to diagnose unhealthy vasculature and to guide and assess therapies. In various embodiments IVUS can be used for imaging only. In various embodiments IVUS can be used for therapy only. In various embodiments IVUS is used for imaging and therapy, with therapies such as heating, coagulation, ablation, ultrasound HIFU, delivery of drugs, anticoagulants (such as heparin, warfarin, dabigatran, apixaban, and / or rivaroxaban), biologics, lytics, thrombolytics, microbubbles, and / or interventional therapies. In one embodiment, the IVUS system includes a disposable catheter used to deploy an ultrasound image acquisition unit within the vasculature and an accompanying imaging system or console. In one embodiment, a processor detects a lengthwise movement of the catheter. The processor may determine a lengthwise position of the catheter using an output device to dictate a lengthwise movement speed to a user and / or using input device to receive the lengthwise movement speed from the user. In some embodiments, the processor may associate IVUS images with the lengthwise position of thecatheter at the time the IVUS images were captured. For example, the processor may annotate the IVUS images to include the lengthwise position. The longitudinal position may be defined relative to an anatomical point of interest. The imaging core comprises a transducer may be a single-element transducer or a multi-element array of transducers in various embodiments. In one embodiment, a single ultrasound transducer (e.g., with only a single element, without multiple elements, without a plurality of elements, and / or without an array of elements) is positioned at an intravascular site with a catheter for acoustic imaging. In various embodiments, a multi-element array may be a 2, 8, 10, 12, 16, 24, 32, 50, 64, 100, 128 element array. In one embodiment, the transducer is rotated by an actuator while the one, two, or more receiving transducers may remain static. The catheter body has a flexible wall extending along the length of the catheter from a proximal end to a distal end. The catheter body also includes one or more lumens, such as a lumen. In one embodiment, the lumen may extend from the proximal end to the distal end of the catheter body. In one embodiment, the lumen may extend from a proximal end to a distal portion of the catheter body. The lumen may be defined by a wall of the catheter body. In one embodiment, the wall of the catheter body is flexible. According to some embodiments, the lumen may be defined by a wall of a member inserted into the catheter body. In some embodiments, the catheter body may include two or more lumens. The lumen may be sealable and comprise a proximal port and a distal port. In various embodiments, images may be formed by a rotating single element or by a multi-element array. During live imaging the acquisition is repeated at an imaging frequency (such as, for example, in the range of 1 – 90 MHz, e.g., 1-10, 10-15, 10-20, 10-25, 10-30, 10-40, 15-30, 15-35, 15-40, 15-50, 15-60, 15-70, 20-30, 30-40, 40-50, 20 -25, 20-30, 20-40, 20-45, 20-50, 25-35, 25-40, 25-45, 25-50, 30-45, 30-50, 40-45, 45-50, 50-60, 50-70, 50-80, 55-75, 55-65, 60-70, 60-90, 70-80, 70-90 MHz and any values and ranges therein). In one embodiment, live imaging the acquisition is repeated at frame rates to provide a real-time 2D imaging modality (such as, for example, frame rates in the range of 12 – 120 Hz, e.g., 12, 15, 20, 25, 30, 35, 40, 45, 50, 55, 60, 65, 70, 75, 80, 90, 100, 110, 120 Hz) . The pullback recording of sequentially acquired IVUS images made while withdrawing the catheter within a vessel can be used to survey a length of a tissue along the blood vessel. In one embodiment, stacking the 2D images recorded during a pullback a volume of data can be constructed. In one embodiment, by stacking a chosen diameter from each of the annular images, an alternate 2D image referred to as a “strip” image can be formed. In one embodiment, the stacking of data from images acquired during a pullback constitutes spatial sampling of the lengthwise dimension, which is out-of-plane with respect to the individual IVUS images. In one embodiment such a stacked image may not be formed, but knowledge of lengthwise separation of individual images is still attainable and advantageous. In some embodiments, one or more markers are spaced along a portion of the length of the catheter body. In various embodiments, 1 – 40 markers (e.g., 1, 2, 4, 5, 6, 7, 8, 9, 10, 12, 16, 20, 24, 25, 30, 32, 35, 38, 40 markers and any values and ranges therein) are distributed along the catheter body. In some embodiments, the markers are evenly spaced longitudinally along the catheter body. For example, the markers may be spaced 0.5 – 6.0 cm (e.g., 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.5, 1.8, 2.0, 2.3, 2.5, 2.7, 3.0, 3.3, 3.5,3.7, 3.8, 3.9, 4.0, 4.1, 4.2, 4.4, 4.5, 4.8, 5.0, 5.3, 5.5., 5.8, 6.0 cm apart and any values and ranges therein). In one embodiment, the markers is radiopaque (RO).

[0158] In various embodiments the markers are disposed on an external surface of the catheter body. The markers may be printed rings disposed on or embedded in the external surface of the catheter body. In one embodiment, the markers are radiopaque ring members disposed within or upon the catheter body. In some embodiments, the marker may be major marker or a minor marker. Major markers may indicate a longitudinal distance such as 2 - 10 cm (e.g., 2, 3, 5, 7, 8, 10 cm and any values and ranges therein), while minor markers may be disposed between major markers and positioned at a particular fraction of the distance between the two major markers. For example, the minor markers may be disposed at every 1 / 10th, 1 / 5th, 1 / 4th, 1 / 3rd, or ½ of the longitudinal distance between two major markers. In some embodiments, the major and minor marker have different sizes such that major markers may be distinguished from minor markers in an image, such as an X-ray image (e.g., radiography, fluoroscopy, and / or angiography image). In one embodiment, a manual pullback IVUS image series capture is recorded while manually translating the catheter along a vessel length. The lengthwise position of the images in the series are estimated by a user / system interaction. This interaction will leverage visible bands or markers on the IVUS catheter that indicate longitudinal translation past one or more surrounding anatomical references. For example, the progress of the translating catheter can be judged by the movement of radiopaque (RO) markers past bony fiducials visible in fluoroscopy or by visible catheter markings past the entry point to the body. In one embodiment, the interaction is a system-to-operator type, such as using audible pacing clicks to pace the operator’s pullback. In one embodiment, the interaction is an operator-to-system type, such as voice entered waypoint indicators given by the operator to the system. By correlating the capture time and physical catheter translation, an image series may be rendered against a length axis in the direction of pullback motion (such as in the case of a “strip” image). In one embodiment, an image series is rendered against lengthwise position, vessel-wise lengths, e.g., distances between images, such as may correspond to desired stent start and end positions in the series can be obtained and documented through the IVUS system user interface. Lengthwise distances between anatomical points of interest can be obtained and utilized with the IVUS images to aid clinical therapy decisions such as selected balloon lengths for percutaneous transluminal angioplasty and expandable stent lengths. In one embodiment, such lengthwise distances between images in the series are obtained whether the image series has been rendered against lengthwise positions or not. In some embodiments, the IVUS catheter system may include an output device. The output device may be an audio output device, a haptic output device, a display device, or a combination thereof. An audio output device may be one or more speakers, headphones, or ear pieces configured to emit a sound, tone, click, word, or phrase. A haptic output device is configured to apply a force to a user, generate a vibration, generate a movement, or a combination thereof. A display device may be any device suitable for providing a visual output, such as a television, a monitor, a mobile device, a tablet, a smart watch, projector screen, visor display, eyepiece, or the like. The output device may provide an output from thesystem to an operator / user, such as a notification, indication, instructions, and / or feedback to the operator / user. In some embodiments, the processor may generate an output and instruct the output device to provide the output to the user. As discussed in greater detail below, the processor may instruct the output device to provide a pacing instruction or pacing notification to a user. For example, at the instruction of the processor, the output device may provide an audio instruction or notification in response to a longitudinal movement of the catheter body. In some embodiments, the IVUS catheter system may include an input device for the operator / user to communicate with the system. The input device may include one or more of a microphone, a tactile input device. A tactile input device may be a keyboard, a button, a switch, a pedal etc. The input device may receive an input from a user, such as a voice-input. In some embodiments, the processor may be placed in electronic communication with the input device and configured to receive inputs from the input device. For example, as discussed below, the processor may receive a pacing input from a user via the input device. According to some embodiments, the catheter system may not include a motorized pullback device. Instead, the catheter body may be moved manually in a longitudinal direction by a user, such as a physician. The system-to-operator interaction output may include a plurality of pacing instructions from the process to the user that dictates a pace at which the user should move sequential markers of the one or more markers should align with the starting anatomical point. For example, a series of sounds, such as beeps, may be played by the system as a pacing output for the user to listen to. The beeps may be played with a steady tempo to dictate to the user the processor’s recommended pullback speed. At a first beep, a first marker of the one or more markers should be aligned with the starting point. In some embodiments, an X- ray image (e.g., radioscopy, fluoroscopy, angiography) is taken of a portion of the patient, and the position of one or more radiopaque markers relative to the starting point may be assessed. The catheter may be moved by the user in a proximal or distal direction, and via the pacing output provided by the system at a second beep, a second marker of the one or more markers is aligned with the starting point. This sequence may continue such that sequential markers of the one or more markers are aligned with the starting point upon each subsequent beep, e.g. a third marker may be aligned at a third beep, a fourth marker may be aligned at a fourth beep, and so on. In some embodiments, the rate at which the one or more markers align with the starting point may correspond with the recommended pullback speed of the catheter. In some embodiments, the recommended pullback speed may be 0.5 – 15 mm / s, e.g., 0.5, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 mm / s. The recommended pullback speed may be a preprogrammed value. In some embodiments, the processor may prompt the user to enter the recommended pullback speed and receive the pullback speed from the user, and can provide audible feedback such as an alarm, and / or request to speed up or slow down. In some embodiments, the processor may receive another indication from the user to end the movement dictation. Similarly, the indication to end the movement direction may be received from the input device. In some embodiments, the system-to-operator interaction output may include an annotated IVUS image. During a movement of the catheter body, the IVUS catheter system may capture one or more IVUS images. The processor may calculate a movement of the catheter body and annotatethe IVUS images to indicate a longitudinal position of the catheter. The longitudinal position may be a position of the distal tip of the catheter relative to a point of insertion or to the starting anatomical point. In some embodiments, the processor may annotate the IVUS image to include a corresponding longitudinal position of the catheter at the time the image is captured. Annotations may be provided in real-time or added retrospectively. According to some embodiments, the processor may annotate the IVUS image to include a speed of the catheter. In one embodiment, a system-to-operator interaction process for detection of a manual longitudinal movement of an IVUS catheter according to one embodiment. In some embodiments, the process may include more or fewer steps. In some embodiments, one or more of the steps of process may be performed in a different order or simultaneously with respect to one or more of the other steps of process. In a system-to-operator interaction embodiment, an operator performing a pullback may be paced by a series of indications from the system representing an intended uniform progress of the observable markings on the catheter past a fixed point. In the system-to-operator embodiment the system guidance can be thought of as guiding pullback speed, similar to how a metronome guides the pace of a beat for a musician playing music. A target pullback rate is programmed in the system (or selected from pre-configured values), e.g., 1-20 mm / sec (e.g., 1, 2, 5, 10, 12, 15, 20 mm / sec and values and ranges therein), and the system provides pacing indicators while the operator performs the pullback (or a push-forward) so that the operator may adapt the translation rate as well as judge the intended rate was achieved. In this embodiment the mapping between image capture time and longitudinal position can be aligned and / or synchronized according to the intended translation rate. In one embodiment, the user may reject a spatial alignment or synchronization and re-attempt the process. In various embodiments, an operator-to-system interaction involves the user inputting information to the system. An operator-to-system interaction process for detection of a manual longitudinal movement of an IVUS catheter may be provided according to one embodiment. In some embodiments, the operator-to-system interaction process may include more or fewer steps. In some embodiments, one or more of the steps of process may be performed in a different order or simultaneously with respect to one or more of the other steps of process. In various embodiments, the input may be received through a user interface or via the input device. For example, the user may provide a keyboard, mouse, touch-screen, or other input to initiate a movement dictation. In some embodiments, the indication may be a speech input, which the processor may receive via the input device. In some embodiments, the indication to start the movement dictation may include an anatomical point which may be a starting point or a reference point. Anatomical points may include an anatomical structure such as an anastomosis, a point relative to a radiopaque structure, a proximal end of a calcified lesion, a distal end of the calcified lesion, etc. In several embodiments, the user may dictate or enter one or more anatomical points to the IVUS catheter system. The operator-to-system interaction process may move to step where the processor may receive a user input. The catheter system may include an input device. The input device may be a microphone, a tactile input device, or a camera. The processor may receive an input from a user, such as a voice-input, via the input device. In some embodiments, the input may be a words or sounds indicating apullback speed. For example, the input device may be a microphone. The user may provide input indicating the pullback speed, and the processor may receive the information and calculate a pullback speed. In some embodiments, the user input may provide a reference point input. A reference point input may associate a current longitudinal position relative to an anatomical point such as a radiopaque structure, a proximal end of a calcified lesion, a distal end of a calcified lesion, or any point where the catheter may be positioned. For example, the input device may be a microphone, and a physician may provide a marker input indicating that a first marker of the one or more markers is aligned with an anatomical point, such as a boney fiducial. At the same time, the distal tip of the catheter may be positioned at a distal end of a calcified lesion. For example, the physician may say “one,” and the processor may receive the speech input via the input device. The user may begin to move the catheter in the proximal / distal direction. According to some embodiments, the user may provide one or more pacing inputs indicating that subsequent markers are disposed at the reference point, and the processor may receive the pacing input(s). The one or more pacing inputs may be entered through the input device and may be touch inputs, speech inputs, mechanical inputs, etc. Based on the pacing inputs, the processor may calculate a longitudinal movement distance based on the one or more pacing inputs and the known distance between the one or more markers. Returning to the example above, the user (e.g., operator, physician, medical personnel) may move the catheter in a proximal direction (e.g., perform a pullback maneuver) after providing the reference point. At the beginning of the pullback maneuver, a first marker of the one or more markers may be aligned with a boney fiducial point. As the physician pulls the catheter in the proximal direction, the physician may provide a second input, such as saying “two,” when a second adjacent marker is aligned with the boney fiducial point, which may be received by the processor via the input device. The movement may continue, and the physician may provide subsequent user provided inputs indicating when a third, fourth, fifth, ... nth marker are aligned with the boney fiducial. Based on the user’s provided inputs, the processor may calculate a position of the catheter and imaging core during the pullback maneuver. In one embodiment, an operator-to-system interaction process for detection of a manual longitudinal movement of an IVUS catheter according to one embodiment. In some embodiments, the operator- to-system interaction process may include more or fewer steps. In some embodiments, one or more of the steps of process may be performed in a different order or simultaneously with respect to one or more of the other steps of process. In one embodiment of an operator-to-system interaction, the operator would provide input to the system regarding manual catheter translation progress during acquisition of the imaging series. For instance, a user may count aloud the catheter markers as they pass by a bony fiducial seen in fluoroscopy, e.g., “Start, One, Two, Three,” etc. with the audible input to a microphone. In this embodiment the spatial distance mapping between image capture time and longitudinal position would be an interpolated function based on the operator inputs. In one embodiment, the system may detect error conditions and reject the spatial measurement calculation. For instance, if missed repeated or out of order counts are detected, or if severely non-uniform counts are detected the system can reject spatial measurement and inform the user so they may repeat the action if desired. In oneembodiment, translation progress indicators could be voice-command such as in the above example embodiment or another input interface mechanism such as buttons on a user-input device like a display screen, button, or foot switch. The ability to audibly indicate translation progress by unique counts / commands, such as spoken “Start, One, Two, Three,” etc. commands rather than a non-specific command likely improve accuracy and robustness. In one embodiment, non-specific progress indicators, such as spoken “Mark, Mark, Mark” indications, or footswitch taps, taps on the catheter body if for instance a haptic sensor is provided, etc. would be sufficient.

[0159] The IVUS system 100 includes an IVUS catheter 102. The IVUS catheter 102 may include a flexible elongate member. In some embodiments, the flexible elongate member may be between 7 -12 feet (e.g., 7, 8, 9, 10, 11, and 12 feet, and values and ranges therein) in length. For example, the IVUS catheter 102 may be at least 3 feet (ft), at least 4 ft, at least 5 ft, at least 6 ft, at least 7 ft, at least 8 ft, at least 9 ft, at least 10 ft, at least 11 ft, at least 12 ft, or at least 13 ft in length. Telescoping members may or may not be included. The flexible elongate member may include a working portion which may be inserted into the patient. In some embodiments, the working portion of the IVUS catheter 102 may be a fixed length. In some embodiments, the working portion of the IVUS catheter 102 has a length configured for connection to a catheter interface module outside of a sterile field. In some embodiments, a non-working portion of the IVUS catheter 102 has a length configured for connection to a catheter interface module outside of a sterile field. The working portion of the IVUS catheter 102 may be, for example, at least 90 cm, at least 120 cm, at least 150 cm, at least 180 cm, at least 210 cm, at least 240 cm, at least 270 cm, at least 300 cm, at least 330 cm, or at least 360 cm in length (e.g., 90, 100, 110, 125, 150, 175, 200, 230, 250, 280, 310, 350, 370, or 400 cm in length including values therein). The elongate flexible member may include or be compatible with a sheath. For example, the sheath may be a 5F sheath or an 8F sheath. The flexible elongate member may include one or more lumens. In various embodiments, the IVUS catheter 102 may include a hydrophilic coating. In various embodiments, the IVUS catheter 102 may include one or more radiopaque markers.

[0160] The IVUS catheter 102 may also include an imaging core. The imaging core may be attached to the distal end of a driveshaft. The imaging core and the driveshaft may be disposed within the lumen of the flexible elongate member. The lumen of the flexible elongate member may be filled with an acoustic coupling medium. In some embodiments, the lumen of the flexible elongate member may be sealable. For example, the imaging core and driveshaft may be placed within the lumen; the lumen may be filled with an acoustic coupling medium; and the lumen may be sealed. In one embodiment, the IVUS catheter 102 is flush-less. In several embodiments, the IVUS system includes a catheter portfolio designed for exceptional performance during peripheral vascular imaging, with a plug and play system with no flushing enabling quick connection and fast imaging, an advanced (optionally high frequency) rotational transducer design enabling high definition image quality, and optimized mechanics enabling superior pushability, tracking, and crossing. In several embodiments, the IVUS system enhances penetration, (e.g., P (mm)) and improves spatial axial resolution, (e.g., ǻZ (mm)) toproduce better image quality. In several embodiments, the IVUS system is stream-lined for intraprocedural clinical workflow that optimizes the user experience throughout the clinical workflow including setup, imaging, measurements, and / or reporting.

[0161] In some embodiments, the IVUS catheter 102 may include a lumen for a guidewire. The guidewire may have an outer diameter between 0.01 and 0.06 inches (e.g., 0.010, 0.012, 0.014, 0.016, 0.018, 0.020, 0.025, 0.030, 0.035, 0.040, 0.045, 0.050, 0.055, and 0.060 inches, including any values and ranges therein). In one embodiment, the IVUS catheter is compatible with a rapid exchange (RX) guide wire with 0.014 inch diameter for a 5F sheath. In one embodiment, the IVUS catheter is compatible with an over the wire (OTW) guide wire with 0.035 inch diameter for a 8F sheath. In various embodiments, the IVUS catheter may include a hydrophilic coating. In various embodiments, the IVUS catheter may include one or more radiopaque markers. In some embodiments, the IVUS catheter may include a rigid connector hub disposed at the proximal end of the flexible elongate member. The rigid connector may mate with the catheter interface module 104. The IVUS catheter 102 may be a plug and play system as described herein. Advantageously, the plug and play system may allow the catheters to be taken out of the sterile package and prepared for use without the need to flush the IVUS catheter 102. The IVUS catheter 102 and the catheter interface module 104 may be connected outside of the sterile field, avoiding the need to drape and / or sterilize additional components, such as the catheter interface module 104.

[0162] The catheter interface module 104 may be a hardware interface between the IVUS catheter 102 and the workstation 106. The catheter interface module 104 may include one or more ports. The port(s) may receive a proximal end of the IVUS catheter 102. For example, the port may receive a rigid connector hub of the IVUS catheter and mate with one or more components of the rigid connector hub to secure the IVUS catheter 102 relative to the catheter interface module 104. The port may provide and facilitate mechanical and / or electronic communication between the IVUS catheter 102, the catheter interface module 104, the tablet 108, and / or the workstation 106. In several embodiments, one or more tablets 108 may be used. In some embodiments, the catheter interface module 104 may include a motor. The motor may rotate the driveshaft and imaging core of the IVUS catheter 102. The motor may be mechanically coupled to the driveshaft of the IVUS catheter 102 via the port. In some embodiments, the motor may rotate the imaging core at a rate of 1500 - 4000 rotations per minute (rpms) (e.g., 1500, 1700, 1800, 1900, 2000, 2200, 2500, 2700, 2900, 3000, 3200, 3400, 3600, 3800, and 4000 rpms, including values and ranges therein). In some embodiments, the port may facilitate an electronic connection between the IVUS catheter 102, the catheter interface module 104, and the workstation 106, e.g. the transmission of instructions or signals received by the imaging core. For example, the port may facilitate a connection between the imaging core of the IVUS catheter 102 and an ultrasound system control board of the workstation 106.

[0163] The IVUS system 100 may include tablet 108 (e.g., computer, laptop, smart phone). In some embodiments, the tablet 108 may include volatile and non-volatile memory to temporarily store data. In one embodiment, the catheter 102 comprises a non-volatile memory to hold identification, usage, and / or calibrationdata. The tablet 108 may include one or more GPUs to process data or render data to the display. In some embodiments, the tablet 108 may include one or more microphones 230, touchscreens, cameras, and / or speakers. In some embodiments, the tablet 108 may be placed in electronic communication with input device such as an external microphone 230 (such as a microphone 230 in a tablet mount 130, 135), a keyboard, a mouse, etc. and / or output device(s) such as a speaker, a display, a haptic feedback device, etc. For example, the tablet 108 may be a medical-grade tablet. The tablet 108 may be connected to a tablet mount 130, 135. The tablet mount 130 may be connected to a universal mount 120, and / or an articulating mount 122. The tablet mount 130 may include microphone 230 that may be placed in electronic communication with the tablet 108. In some embodiments, one or more microphones 230 may be used. In some embodiments, the tablet 108 may be connected to one or more mounts and / or docking stations. The docking station may include a keyboard, a mouse, a microphone, and / or speaker(s). In some embodiments, the tablet mount 130 may include voice control electronics, such as one or more microphones 230, speakers, audio cards, and / or audio processors. In several embodiments the IVUS system 100 may include voice control electronics with the technology described in U.S. Patent Serial No.63 / 459,312 entitled Systems and Methods for Flush-Less Intravascular Ultrasound Catheter, and / or No.63 / 531,266 entitled Systems and Methods of Manually Assisted Pullback for Spatial Alignment Lengthwise Measurements in Intravascular Ultrasound Imaging, all herein incorporated by reference. In several embodiments, the tablet mount 130 is configured for increased ease of setup and use of an IVUS system 100. The technology described herein, including the mounts, voice control, ease of setup and providing for set up outside a sterile field with catheters with lengths of 8 feet or more are used in several embodiments with flush-less, encapsulated seal IVUS catheters to reduce air bubbles and eliminate need to flush acoustic coupling medium including the technology described in U.S. Patent Serial No. 63 / 459,312 entitled Systems and Methods for Flush-Less Intravascular Ultrasound Catheter, U.S. Patent Serial No. 63 / 546,091 entitled Systems and Methods for Flush-Less Intravascular Ultrasound Catheter, and International Patent Serial No. PCT / US2024 / 024045 entitled Flush-Less Intravascular Ultrasound Technology; intraluminal image focusing with spinning single element ultrasound transducer via modification of image (e.g., angular diffraction, phase, amplitude, time shift, compositing backscatter reflected images) including the technology described in U.S. Patent Serial No.63 / 497,962 entitled Spinning Single Element Ultrasound Transducer and Focusing Methods and International Patent Serial No. PCT / US2024 / 024035 entitled Spinning Single Element Ultrasound Transducer and Focusing Technology; manually assisted pullback for spatial alignment measurements, voice control, position sensors (e.g., encoder) including the technology described in U.S. Patent Serial No. 63 / 531,266 entitled Systems and Methods of Manually Assisted Pullback for Spatial Alignment Lengthwise Measurements in Intravascular Ultrasound Imaging and International Patent Serial No. PCT / US2024 / 041134 entitled Systems and Methods of Manually Assisted Movement for Spatial Alignment Lengthwise Measurements in Intravascular Ultrasound Imaging; and circuitry and electronic architecture includingthe technology described in U.S. Patent Serial No.63 / 632,966 entitled Electronic Architecture For Intravascular Ultrasound Technology, all herein incorporated by reference.

[0164] The IVUS system 100 may include a workstation 106, which includes a non-transitory memory and one or more processors. The memory may store instructions, which may be executed by the processor. The workstation 106 may include sufficient high-speed DRAM to capture a high fidelity ultrasound data for a plurality of IVUS image lines, e.g. a “pullback” recording, and provide the IVUS images for display in real time after processing image lines in a multi-channel processing pipeline. In some embodiments, memory may store information associated with the IVUS system 100 or the components thereof. The memory may store information associated with the IVUS catheter 102. Catheter information may include catheter identification information, usage data, and calibration data. Catheter identification information may include a unique catheter identification number, model number, etc. Usage data may include time in use, number of rotations, number of images captured, mechanical properties of the IVUS catheter 102, manufacture date, expiration date, and / or material properties of the IVUS catheter 102. In some embodiments, the workstation 106 may include Ultrasound System Control (USC) board. In one embodiment, the USC board is configured for increased ease of setup of an IVUS system 100. The USC may include one or more hardware components configured to capture and generate IVUS images in real time. For example, the workstation may include one or more GPUs and / or USCs. The USC may be configured to perform high-throughput processes to generate an IVUS image. The USC may provide high-speed processing, high dynamic range signal capacity, and / or high-end signal processing support precise control of transmit waveforms and receive processing to maximum spatial resolution, temporal resolution, and image contrast for superior image quality and image interpretation.

[0165] In one embodiment, the processor of the workstation 106 may instruct or control one or more components of the IVUS system 100. In some embodiments, the processor may be placed in electronic communication with the patient chassis 114, IVUS catheter 102, the catheter interface module 104, and / or the tablet 108. In some embodiments, the processor may be placed in electronic communication with the IVUS catheter 102 via the catheter interface module 104. The processor may communicate with the components of the IVUS system 100 via a wired connection or a wireless connections, e.g. via a wireless network. For example, the IVUS system 100 may use a WiFi, Bluetooth®, and / or a cellular network to connect a plurality of devices, such as the workstation 106 and the tablet 108. The wireless network may provide data rates of 500 megabits per second (Mbps) at ranges of about 12 meters. In some embodiments, the workstation 106 may include a WiFi card that includes a transmitter and a receiver. The processor of the workstation 106 may generate and control a wireless network via the WiFi card. In some embodiments, the networked components may be automatically configured with zero-configuration technology. The network may utilize WiFi card(s) of the one or more devices, driver settings, and / or wireless network protocol settings to ensure the network has sufficient bandwidth to exchange and synchronize IVUS image data. The wireless network protocol settings may include encryption settings,network “band” settings, network channel settings. The wireless network may have various bandwidths (e.g., can support connections via data compression, etc.) and support connections between the computer and the one or more tablets 108. The processor of the workstation 106 may synchronize data transmitted across the network to synchronize a display on each device. Advantageously, the local network generated by the processor may provide lower latency (e.g., 10 milliseconds (ms)) across the devices of the IVUS system and provide greater ease of use.

[0166] In some embodiments, a network may include one or more security features, such as a security key, firewall, etc. For example, the network may be password protected. In another example, the network may automatically connect to a device, but require a security key to be input into the device before a connection can be fully established. For example, a device may be manually paired during a first procedure, and for a subsequent procedure, the workstation 106 may automatically connect to the device. In some embodiments, devices may receive a token from the computer and respond with the device’s availability and identification information. Once a secure network connection is established, the tablet or tablet mount may utilize a camera to enable a secure login using face recognition. In another example, the tablet or tablet mount or workstation may utilize voice recognition to enable a secure login.

[0167] The processor may collect the availability and information of a plurality of devices and provide the available devices in a list. In some embodiments, a user may specify criteria for the devices, such as a particular functionality or capability, and the processor may return a list of devices that are available and meet the user’s device criteria. A user may select one or more devices, and the processor may send a signal to the selected devices. In some embodiments, the signal may initiate a connection between the workstation 106 and the selected devices. In some embodiments, the signal may include a security key, which may be displayed on the selected device(s). A unique security key may be generated for each selected device. A user may enter the security key into the workstation 106, and in response the processor may initiate a connection with the selected device(s).

[0168] In various embodiments, the IVUS system 100 includes an IVUS catheter 102, a catheter interface module 104, a workstation 106 (e.g., computing device, computer, processor system), and at least one tablet 108. Each of the catheter interface module 104, the workstation 106, and the tablet 108 may optionally be removably connected to one or more mounts. In several embodiments, one or more mounts are configured to connect certain components of the IVUS system 100. In one embodiment, a universal mount is configured for increased ease of setup of an IVUS system 100. The mount may also provide power and / or data connectivity (wireless or wired ready for integration into lab IT infrastructure (e.g., picture archiving and communication system (PACS) electronic medical record (EMR) or electronic healthcare record (EHR)), microphones, and / or speakers to the components of the IVUS system 100.

[0169] In some embodiments, the mount may be removably attached to a mounting surface 112 or other component. In some embodiments, a mount may be made from durable materials, such as plastic and / or,such as aluminum. In some embodiments, mount materials may be molded, machined, and / or printed as a 3D model. In several embodiments, a mount comprises one or more releasably attachable interfaces 210 (e.g., latch, hook, clamp, dial, clip, knob, crew, threaded interface, detent interface, locking mechanism, actuating mechanism, spring loaded mechanism, fiducial alignment pin / connectors, adhesive,) for attaching to a component. In various embodiments, a mount can be a universal mount 120, an articulating mount 122, or a tablet mount 130, 135.

[0170] The universal mount 120 may be removably connected to a mounting surface 112 (e.g., connective feature, rail (such as a bed rail), mobile cart feature, etc.) and any of a catheter interface module 104, a workstation 106, a tablet 108, a mobile cart 116, an articulating mount 122, a tablet mount 130 in several embodiments. The universal mount 120 has a mounting surface interface for mechanically connecting to a mounting surface 112. In several embodiments, the mounting surface interface comprises one or more releasably attachable interfaces 210 (e.g., latch, hook, clamp, dial, clip, knob, crew, threaded interface, detent interface, locking mechanism, actuating mechanism, spring loaded mechanism, fiducial alignment pin / connectors, adhesive,) for attaching to a component. In one embodiment, the mounting surface 112 comprises an electrical contact 220 configured for electronic communication, e.g., an electrical connector, port, plug, pin connector for communicating an electrical signal (e.g., wired, wireless, signals, data, sensors, USB, HDMI, etc.) and / or power (e.g., AC, DC, battery, etc.). In several embodiments, the universal mount 120 further includes a second interface for mechanically and / or electronically connecting any of a catheter interface module 104, a workstation 106, a tablet 108, a mobile cart 116, an articulating mount 122, a tablet mount 130.

[0171] The articulating mount 122 may be removably connected to any of a mounting surface 112 (e.g., connective feature, rail (such as a bed rail), mobile cart feature, etc.), a catheter interface module 104, a workstation 106, a tablet 108, a mobile cart 116, a universal mount 120, a tablet mount 130 in several embodiments. The articulating mount 122 has one or more articulating portions configured for controllable movement and / or positioning, such as a hinge, and ball and socket, and locking feature, one or more articulator arms 400. In several embodiments, the articulating mount 122 has one or more articulating mount interfaces 124 for mechanically and / or electronically connecting any of a mounting surface 112, a catheter interface module 104, a workstation 106, a tablet 108, a mobile cart 116, and / or a tablet mount 130. In several embodiments, the articulating mount interface 124 comprises one or more surfaces for attaching to a component, e.g., latch, hook, clamp, dial, clip, knob, crew, threaded interface, detent interface, locking mechanism, actuating mechanism, etc. for mechanically connecting to a mounting surface 112. The mounting surface 112 may be a bed rail as shown in FIG.1 or may be any other sterile or non-sterile surface such as a connective feature, a rail (such as a bed rail), mobile cart feature, table, table rail, etc. In several embodiments, the articulating mount interface 124 one or more releasably attachable interfaces 210 (e.g., latch, hook, clamp, dial, clip, knob, crew, threaded interface, detent interface, locking mechanism, actuating mechanism, spring loaded mechanism, fiducial alignment pin / connectors, adhesive,) for attaching to a component. In various embodiments, articulating mount interface 124 comprises anelectrical contact 220 configured for electronic communication, e.g., an electrical connector, port, plug, pin connector for communicating an electrical signal (wired, wireless, signals, data, sensors, etc.) and / or power (e.g., AC, DC, battery, etc.).

[0172] The tablet mount 130, 135 may be removably connected to a tablet 108 and any of a surface (e.g., table, desk, floor, chair, cart), a mounting surface 112 (e.g., connective feature, rail (such as a bed rail), mobile cart feature, etc.), a catheter interface module 104, a workstation 106, a mobile cart 116, a universal mount 120, an articulating mount 122. The tablet mount 130, 135 can have one or more tablet mount interfaces 126 for mechanically and / or electronically connecting any of a tablet 108, a mounting surface 112, a catheter interface module 104, a workstation 106, a mobile cart 116, universal mount 120, and / or an articulating mount 122. In several embodiments, the tablet mount interface 126 comprises one or more releasably attachable interfaces 210 (e.g., latch, hook, clamp, dial, clip, knob, crew, threaded interface, detent interface, locking mechanism, actuating mechanism, spring loaded mechanism, fiducial alignment pin / connectors, adhesive,) for attaching to a component. In various embodiments, tablet mount interface 126 comprises an electrical contact 220 configured for electronic communication, e.g., an electrical connector, port, plug, pin connector for communicating an electrical signal (wired, wireless, signals, data, sensors, etc.) and / or power (e.g., AC, DC, battery, etc.). Microphones, sound arrays, speakers, Audio Front End (AFE) functions, noise cancelling filters, and processors / chips, are integrated into the tablet mount 130, 135 to support voice recognition functions according to several embodiments.

[0173] In one embodiment, the IVUS system 100 includes a movable patient chassis 114 with a patient surface (e.g., table, platform, bed, mattress, chair, etc.). In various embodiments, the movable patient chassis 114 may include the patient surface, a plurality of wheels, one or more mounting surfaces 112, and one or more mounts. The patient surface may include a cushion or mattress that is sufficient in size to allow a patient to lie down on during an IVUS procedure. In some embodiments, the mounting surface 112 may include a bed rail disposed adjacent to or spaced around the patient surface. The universal mount 120 may be disposed on the mounting surface 112. In some embodiments, the universal mount 120 may be integrally formed in the mounting surfaces 112. For example, a bed rail may be molded to include a universal mount 120. In some embodiments, the IVUS system 100 may include one or more of a patient chassis 114 and a mobile cart 116. For example, the IVUS system 100 may include components shown in Fig.1 and a mobile cart 116, such as the cart shown in Fig. 2.

[0174] During an IVUS procedure, a proximal end of the IVUS catheter 102 may be connected to the catheter interface module 104 via a mount. The catheter interface module 104 may be disposed outside of a sterile field. In one embodiment, the catheter interface module 104 is configured for increased ease of setup of an IVUS system 100. In some embodiments, the catheter interface module 104 may be mounted to the patient chassis 114. For example, a rigid connector hub disposed at the proximal end of the IVUS catheter 102 may be mated with a port of the catheter interface module 104. The catheter interface module 104 may be mounted outside ofthe sterile field on a bed rail of the patient chassis 114 by a catheter interface module mount. In one embodiment, an articulator arm 400 for a universal mount 120 is configured to hold the catheter interface module 104 with a load of up to 20 pounds (e.g., up to 1, 2, 3, 4, 5, 8, 10, 12, 14, 16, 18, 20 pounds and overlapping values and ranges therein) in weight in a fixed desired position. In one embodiment, the articulator arm 400 is capable of angular motion of 1 – 180 degrees in 1, 2, or 3 dimensions, and is rotatable between 1 – 360 degrees in the X, Y, and Z axis. In one embodiment, each joint in the articulator arm 400 can be locked in position, unlocked, repositioned, and locked in another position.

[0175] In some embodiments, the tablet 108 may be mounted to the patient chassis 114 via a universal mount 120. In one embodiment, the tablet 108 is configured for increased ease of setup of an IVUS system 100. For example, the tablet 108 may be mounted to a bed rail of the patient chassis 114 with a universal mount 120, articulating mount 122, and / or a tablet mount 130. The tablet mount may include one or more device engagement surfaces to receive a tablet 108. The tablet mount 130 may include an articulation mechanism, such as a ball and socket joint, which allows the tablet to be turned or repositioned while disposed within the tablet mount. The tablet mount 130 may mate with other components such as the patient chassis 114, a mobile cart 116 that houses the workstation 106, etc. In some embodiments, the tablet mount 130 may include one or more microphones and / or speakers. The tablet 108 may be placed in electronic communication with the catheter interface module 104 and / or the workstation 106. In some embodiments, the tablet(s) may be wirelessly connected to the catheter interface module 104 and / or the workstation 106. For example, the tablet 108 may be placed in communication with a workstation or other computing device via a Wi-Fi network or Bluetooth connection. The tablet 108 may automatically discover and connect with one or more system components connected to a network such as the workstation 106, other tablets, mounts, etc. according to some embodiments. The tablet 108 may identify devices on a network or within a range of the tablet 108 and provide a list of devices to a user. In one embodiment the tablet or the workstation can create a private network, e.g. Bluetooth connectivity or hotspot that enables connection of only the system components. For example, the tablet 108 may discover a network, e.g. through zero-configuration networking, and may identify one or more devices (e.g., workstations and / or tablet initiated connections) that may be connected to the network. The user may select one or more devices from the list, and the tablet 108 may wirelessly connect to the selected devices. In order to facilitate the connection, a user may enter a security key into the tablet 108 and / or the selected device according to some embodiments. In some embodiments, the tablet(s) may be connected to the catheter interface module 104 and / or the workstation 106 via a wired connection. For example, the one or more mounts may facilitate electronic communication between the tablet 108, the catheter interface module 104, and / or the workstation 106.

[0176] In several embodiments, tablet mount 130 may determine whether a direction of a verbal command is toward or away from the tablet mount 130. If the direction of the verbal command is away from the tablet mount 130, such as the clinician is facing away from the tablet mount 130 microphone(s), the tablet mount130 may ignore the command. If the verbal command is toward the tablet mount 130, such as the clinician is facing the tablet mount 130 microphone(s), the tablet mount 130 may transmit the verbal command to the tablet 108 and / or the workstation 106. In some embodiments, the tablet mount 130 may determine a grammar context and / or a social cue context of the verbal command and transmit the verbal command to the tablet 108 and / or the workstation 106 along with the grammar and social cue context. The tablet mount 130 may identify the voice of a speaker according to some embodiments. The tablet mount 130 may determine if the speaker is authorized to give verbal commands (e.g., via voice login). For example, a list of authorized users may be received by the IVUS system 100, such as via the workstation 106, the tablet 108, and / or the tablet mount 130. The tablet mount 130 may identify the voice of a speaker, determine whether the speaker is on the list of authorized users, and process and / or transmit the verbal command based on the determination that the speaker is an authorized user. In some embodiments, authorized users may be added through a setup or initialization process where a user provides one or more verbal training commands. The tablet mount 130 may receive the one or more training commands and identify one or more vocal patterns associated with the user. When a verbal command is received, the tablet mount 130 may identify vocal patterns of the vernal command and determine if the speaker is an authorized user based on the one or more vocal patterns associated with the user and the vocal patterns of the verbal command. Although the functions described above are described as being performed by the tablet mount 130, they may be performed by one or more of the tablet mount 130, the tablet 108, and / or the workstation 106. In several embodiments, the tablet mount 130 may receive a voice command from a user and may transmit the voice command to the tablet 108 for processing. In one embodiment, the one or more tablets 108 may include one or more microphones. The tablet 108 may receive the voice command and transmit the voice command to the workstation 106 for processing. The tablet 108 may receive the voice command from a microphone and send data to a workstation 106 with voice recognition capabilities, which then sends a command to the tablet 108.

[0177] In some embodiments, the catheter interface module 104, workstation 106, the tablet 108, mount(s), patient chassis 114, and / or the mobile cart 116 may be used to facilitate other patient procedures. The patient procedures may include other catheter-based imaging procedures as well as non-catheter-based imaging procedures. Imaging procedures may include ultrasound, x-ray, computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography (PET), PET-CT, fluoroscopy, endoscopy, angiography, optical coherence tomography, intravital microscopy, etc. In some embodiments, using the catheter interface module 104, the workstation 106, the tablet 108, the mount(s), patient chassis 114, and / or the mobile cart 116 in imaging procedures enhances usability, clinical efficacy, and reduces operating times, among others.

[0178] The IVUS system 100 may also be used for imaging, diagnosing, and / or providing an image-guided intervention in the digestive tract, esophagus, stomach, intestine, rectum, eye, for ocular purposes, for ENT (ear, nose, throat) purposes, sinus, ear, nose (e.g., for nose bleeds such as epistaxis), throat, for urology purposes, ureter, bladder, uterus, fallopian tubes, etc. In various embodiments, system 100 is an ultrasoundsystem. In various embodiments, an ultrasound system 100 and / or an IVUS system 100 may be used with or without the IVUS catheter 102. Other imaging systems, such as an endoscope, intravital microscopy, etc. may be used with the system. For example, the systems and methods described herein may be used in conjunction with an endoscope rather than as an IVUS catheter and can be used to support identification and diagnoses of tumors, such as tumors in the intestines and / or biliary ducts. Similarly, the systems and methods described herein may be used to image a sinus cavity using IVUS. Interventions include for example targeted drug delivery before, during or after imaging with the systems described herein, according to some embodiments. Tumors that can be visualized and optionally treated according to several embodiments herein include, for example, fibroids, polyps, abnormal cell clusters, etc. including but not limited to those located in reproductive organs such as the uterus, the nasal or ear cavity, rectum, colon, other intestinal regions or elsewhere. In some embodiments, the ultrasound imaging technologies described herein are used to visualize fluids, whether internal or externally delivered. Drug delivery, including for example via fluid or nano particle delivery, may also be visualized. Such visualization may be helpful for confirming delivery to the desired target region, saturation, etc. in a vessel or other lumen, to a tumor or other abnormality (such as thrombus, plaque, calcium, etc.). Visualization may be before, after and / or during delivery of a drug and real-time visualization is provided in several aspects. In one embodiment, ultrasound is also used to facilitate drug delivery.

[0179] Fig.2 depicts an embodiment of an IVUS system 100 that includes a patient chassis 114, a mobile cart 116, an IVUS catheter 102, a catheter interface module 104, one or more tablets 108, and a workstation 106. The patient chassis 114 may include a patient surface and one or more mounting surfaces 112. For example, the patient chassis 114 may be a hospital bed. In various embodiments, the mobile cart 116 can include a workstation 106, a tablet 108, a display monitor 450 (e.g., the display monitor 450 may be on the tablet 108 or separate from a tablet 108). In some embodiments, a first group of one or more components may be mounted on the patient chassis 114, and a second group of one or more components may be mounted on the mobile cart 116.

[0180] Fig.3A illustrates a tablet mount 130 according to one embodiment. The tablet mount 130 may be removably connected to a tablet 108 and any of a surface (e.g., table, desk, floor, chair, cart), a mounting surface 112 (e.g., connective feature, rail (such as a bed rail), mobile cart feature, etc.), a catheter interface module 104, a workstation 106, a mobile cart 116, a universal mount 120, an articulating mount 122. The tablet mount 130, 135 can have one or more tablet mount interfaces 126 for mechanically and / or electronically connecting any of a tablet 108, a mounting surface 112, a catheter interface module 104, a workstation 106, a tablet 108, a mobile cart 116, universal mount 120, and / or an articulating mount 122. In several embodiments, the tablet mount interface 126 comprises an electrical contact 220 configured for electronic communication, e.g., an electrical connector, port, plug, pin connector for communicating an electrical signal (wired, wireless, signals, data, sensors, etc.) and / or power (e.g., AC, DC, battery, etc.). The tablet mount 130 can comprise one or more lockable interfaces210 to actuate and attach surfaces to a bed rail or other surface and is configured to clamp a tablet 108 in one or more positions. In several embodiments, the tablet mount 130 comprises one or more releasably attachable interfaces 210 (e.g., latch, hook, clamp, dial, clip, knob, crew, threaded interface, detent interface, locking mechanism, actuating mechanism, spring loaded mechanism, fiducial alignment pin / connectors, adhesive,) for attaching to a component. In one embodiment, a latch 210 is actuated to a release a tablet mount interface 126 in order to remove a tablet 108. In one embodiment, a latch 210 is actuated to a release a tablet mount interface 126 in order to remove connection to another component, such as a mounting surface 112, a universal mount 120, an articulating mount 122, a catheter interface module 104, a workstation 106, or a mobile cart 116. In some embodiments, the tablet mount 130 comprises one or more electrical contacts 220, electronic components (such as one or more power ports, power interfaces, microphones 230, chips, processors, lights, indicators, and / or speakers). The tablet mount may include one or more lockable interfaces 210.

[0181] Figs.3A, 3B, 4, and 4B illustrate the tablet mount 130 with one or more microphones 230 according to several embodiments. Microphones 230, sound arrays, speakers, Audio Front End (AFE) functions, noise cancelling filters, and processors / chips, can be integrated into the tablet mount 130 to support voice recognition functions. In one embodiment, microphone 230 is an array microphone. In one embodiment, microphone 230 is configured as a directional microphone via one, two, three, four or more microphone elements to detect a direction or position from which a sound is detected (e.g., locating where a speaking individual is using a voice, such as to provide instructions to the microphone). The tablet mount 130 may determine whether a direction of a verbal command is in one or more preferential directions. The preferential direction(s) may be toward the tablet mount 130 from a known position of one or more user(s). For example, during a setup, a position of a physician may be determined based on one or more initializing commands provided by the physician, such as a wake command. In another example, the preferential direction(s) may be automatically set, and the physician may be directed to position themselves in a known position In another example, the preferential direction(s) may be automatically set, and the physician may be directed to position themselves in a known position based on the preferential direction. If a verbal command is detected in a direction other than the preferential direction, the tablet mount 130 may ignore the command. If the verbal command is in a preferential direction to the tablet mount 130, the tablet mount 130 may transmit the verbal command to the tablet 108 and / or the workstation 106. In some embodiments, the tablet mount 130 may determine a grammar context and / or a social cue context of the verbal command and transmit the verbal command to the tablet 108 and / or the workstation 106 which may also include the grammar and social cue context. The preferential direction may be set by the user or automatically detected by the system.

[0182] In one embodiment, microphone 230 is mounted at one or more locations on a tablet mount 130. In one embodiment, one or more electrical contacts 220 mate or interlock with an engagement feature on a tablet 108. Fig.4A illustrates a rear view of a tablet mount 130 with one or more levers 210 and a DC powerconnector according to Fig.3A. Fig.4B illustrates a cutaway view of a tablet mount 130 with one or more levers 210 and internal wire routing according to Fig.3A.

[0183] Fig.5 illustrates a schematic PC board 300 circuit diagram with electronic components of a tablet mount 130 according to one embodiment. In various embodiments, the tablet mount 130 comprises one or more docking stations, pin connectors, power supplies, AC connections, DC connections, chips, circuits, flash drives, USB connectors, processors, transmitters, transformers, control chips, voice control chips, inputs, outputs, and connectors. In several embodiments, the tablet mount interface 126 comprises an electrical contact 220 configured for electronic communication, e.g., an electrical connector, port, plug, pin connector for communicating an electrical signal (wired, wireless, signals, data, sensors, etc.) and / or power (e.g., AC, DC, battery, etc.). In one embodiment, the PCB and microphone may be connected.

[0184] Fig. 6. illustrates a block diagram of the PC board 300 docking station with electronic components of a tablet mount 130 according to one embodiment. In various embodiments, the tablet mount 130 comprises one or more tablet interfaces, power interfaces, microphones, microphone connections, docking connectors, DC supply connectors, docking station controllers, power regulation components, and audio processors (e.g., far-field audio processors).

[0185] Fig.7 illustrates a tablet mount 130 attached to an articulating mount 122 with one or more articulator arms 400 according to one embodiment. In one embodiment, an articulator arm 400 of an articulating mount 122 is attached to a tablet mount 130 is configured to hold a tablet 108 of up to 20 pounds (e.g., 1, 2, 3, 4, 5, 8, 10, 12, 14, 16, 18, 20 pounds) in weight in a fixed desired position. In one embodiment, the articulator arm 400 is capable of angular motion of 1 – 180 degrees in 1, 2, or 3 dimensions, and is rotatable between 1 – 360 degrees in the X, Y, and Z axis. In one embodiment, each joint in the articulator arm 400 can be locked in position, unlocked, repositioned, and locked in another position. The universal mount 120 may be mechanically coupled to a rail 112 of the patient chassis 114 in some embodiments. The universal mount 120 may be repositionable along the rail, e.g. the universal mount 120 may slide along the rail. In some embodiments, the universal mount 120 may be secured in a position along the rail by a screw assembly. The universal mount 120 may be coupled to a chassis at a mount receiving component, e.g. a projection, a pocket, a rail, a threaded member, etc. according to some embodiments. The universal mount 120 may include a corresponding mounting surface, e.g. a clip or clasp to engage a projection, a threaded member, etc.

[0186] Fig.8 illustrates a universal mount 120 attached to an articulating mount 122 with one or more articulator arms 400 attached to a tablet mount 130 according to one embodiment. In one embodiment, an articulator arm 400 for a articulating mount 122 is configured to hold a tablet 108 of up to 20 pounds (e.g., 1, 2, 3, 4, 5, 8, 10, 12, 14, 16, 18, 20 pounds) in weight in a fixed desired position. In one embodiment, the articulator arm 400 is capable of angular motion of 1 – 180 degrees in 1, 2, or 3 dimensions, and is rotatable between 1 – 360degrees in the X, Y, and Z axis. In one embodiment, each joint in the articulator arm 400 can be locked in position, unlocked, repositioned, and locked in another position.

[0187] Fig.9A illustrates a mobile cart 116 with wheels, a workstation 106, a power connector 410, one or more component holders 420, a handle 430, storage compartment 440, and a display monitor 450 and / or a tablet 108 according to one embodiment. The mobile cart 116 may include a power connector retention member. The power connection retention member may be a hook that the power connector 410 (e.g., power cord, power connector) may be wrapped around. In some embodiments, the power connector holder may be disposed within a compartment of the mobile cart 116. The power connector holder may automatically retract the power connector 410 into the compartment. In one embodiment, the display monitor 450 is configured to have a 12 inch – 36 inch screen (e.g., 12, 13, 15, 18, 20, 22, 24, 28, 30, 32, 36 inch screen and any values and ranges therein). The display monitor 450 may be a tablet 108.

[0188] Fig.9B illustrates a mobile cart 116 with wheels, a power connector 410, one or more component holders 420, a handle 430, and storage compartment 440, a display monitor 450, an IV pole 460, and one or more IV bags 470 according to one embodiment. The mobile cart 116 may be coupled with the IV pole 460 such that the two components may be movable together. In some embodiments, the IV pole 460 may be a fixed component of the mobile cart 116 and configured to receive the one or more mounts.

[0189] Fig.10A illustrates a mobile cart 116 according to one embodiment. Fig.10B illustrates a tablet mount 130 configured to attach to a tablet 108 and to a mounting surface 112 (e.g., mobile cart feature) directly or via a universal mount 120 according to one embodiment. In one embodiment, the tablet 108 is configured for adjustment of up to 45 degrees from a vertical position on a bed rail. Fig. 10C illustrates an interactive user tablet 108 attached to a tablet mount 135 configured for placement on a surface (e.g., table, desk, floor, chair, cart) with a touch screen according to one embodiment. In various embodiments, the interactive user tablet 108 can include a user interface, a microphone 230, camera, speaker or other electronic component, and a tablet mount 135 configured for placement on a surface.

[0190] Fig.11A illustrates a tablet mount 130 with a release slider and a tablet 108 on a portion of a mobile cart 116 according to one embodiment. Fig.11B illustrates a tablet mount 130 with tablet mount interfaces 126 and a latch with an alignment cover according to one embodiment. Fig.11C illustrates a tablet mount 130 with tablet mount interfaces 126 and according to one embodiment.

[0191] In several embodiments, a clinician may initiate an IVUS procedure with the IVUS system 100 via the tablet 108 and / or the workstation 106. The tablet 108 may execute a user interface. The workstation 106 may execute a user interface. The tablet 108 may receive commands from a clinician via the user interface. In some embodiments, the user interface may be a voice user interface, and the tablet 108 may receive a voice command from a user via a microphone. The tablet mount 130 may include one or more microphones. In some embodiments, the tablet 108 may include a camera, and the user interface may receive a gesture command froma user via a camera. The camera may capture a gesture, and the tablet 108 may detect the gesture, determine whether the gesture is one of a plurality of gesture commands, and transmit the gesture command to the workstation if the gesture corresponds with a gesture command. In some embodiments, the tablet mount 130 may include the camera. Similarly, the camera may capture a gesture performed by a user, and the tablet mount 130 may detect the gesture from the user, determine whether the gesture is one of a plurality of gesture commands, and transmit the gesture command to the workstation if the gesture corresponds with a gesture command. In some embodiments, the camera can identify authorized users for providing gestures. In one embodiment, the system is configured to capture a face of the user via a camera and authenticate the user based on one or more facial features. In response to receiving an input via the user interface, the tablet 108 may provide a feedback to the user such as a haptic feedback, an audio feedback, and / or a visual feedback. For example, in some embodiments, a haptic feedback may be provided when a user enters a touch input to select an element of a touch user interface, can incorporate haptic feedback to provide user feedback when the user interacts with the UI through the tablet, use haptic feedback when scrubbing over the timeline to indicate where a tissue lumen diameter is a certain value, changing, maximized, and / or minimal, and / or use haptic feedback on button presses to indicate that an action is occurring. The user interface may include one or more controls that can be activated by touch, voice, or gesture. In one embodiment, the one or more interfaces are configured for increased ease of setup of an IVUS system 100. In some embodiments, the user interface may include an imaging interface, a measurement interface, and / or a summary interface. The imaging interface may be a simplified screen that is image centric with user interface (UI) elements minimized to product a visually simple screen. For example, the IVUS image may be the most prominent element and other elements may be minimized. The imaging interface may include one or more touch screen buttons that trigger image actions. The touch screen buttons may be radially located around the IVUS image. Navigation buttons may be located in the upper right of the screen. The imaging interface, the measurement interface, and the summary interface are described in greater detail in conjunction with Figs.12A-14B according to several embodiments.

[0192] Fig.12A illustrates an imaging interface 1200 according to one embodiment. The imaging interface 1200 may be a simplified screen that is image centric with user interface (UI) elements minimized to product a visually simple screen. In various embodiments , the imaging interface 1200 is on a tablet 108 and / or a display monitor 450. In some embodiments, the imaging interface 1200 may be a touch user interface. For example, the imaging interface 1200 may be displayed on a tablet 108 with a touchscreen, and a user may select or interact with elements of the imaging interface 1200. The imaging interface 1200 may include a voice user interface and receive voice commands from a user. The voice commands may initiate a voice interaction with the element(s) of the imaging interface 1200, the measurement interface 1300, and / or the summary interface 1400 described herein. In some embodiments, the imaging interface 1200 may receive touch and voice commands from the user. The user interface 1200 may be customizable by a user. For example, the user may change a colorscheme to a default color scheme, a “color blind” mode, a “negative” mode, which inverts the default color scheme, or a set of colors selected by a user. The color -blind mode may include colors that allow users affected by different types of color blindness, e.g. protanopia, deuteranopia, achromatopsia, etc. to differentiate between elements and sub elements of the user interface 1200.

[0193] The imaging interface 1200 may include an IVUS image 1202 at the center of the imaging interface. The IVUS image 1202 may be a still image, video, or a "live" video captured by an IVUS catheter, such as the IVUS catheter 102. In some embodiments, the IVUS image 1202 may be overlayed with a “crosshair” type orientation element 1204. The center of the orientation element 1204 may be overlayed with a center of the IVUS image 1202 and correspond with a location of the imaging core of an IVUS catheter. The imaging interface 1200 may include one or more elements. The one or more elements may allow a user to navigate the imaging interface 1200, measure, and / or analyze one or more IVUS images. The one or more elements may be disposed radially around the IVUS image 1202 within the imaging interface 1200. The radial position of the one or more elements may enable a user to navigate the imaging interface easier and maintain focus on the IVUS image 1202. In some embodiments, a user may rearrange the one or more elements to a desired position. For example, an element may be moved from a left side to a right side of the user interface 1200.

[0194] The one or more elements may include a live image element 1206, a record element 1208, a brightness control element 1210, a zoom control element 1212, and a product branding element 1214, a settings element 1216. The live image element 1206 may be selected by a user and cause the IVUS image 1202 displayed in the imaging interface 1200 to be the IVUS images concurrently being collected by an IVUS catheter. The record element 1208 may initialize or end a recording of the IVUS image 1202. A user may move an IVUS catheter during a recording or maintain the catheter in the same position within the patient. For example, a medical professional may record a stenotic vessel during a breathing cycle and / or a heart cycle. In another example, a medical professional may move the catheter through a stenotic region of a vessel, begin a recording by selecting the record element 1208, and retract the catheter to image the stenotic region. In some embodiments, the recording may be initiated through a voice command. The settings element 1216 may be used to open or close a settings menu. In some embodiments, the imaging interface 1200 may include a voice interface element 1218. The voice interface element 1218 may active a voice user interface.

[0195] The brightness control element 1210 may control one or more properties of the IVUS image 1202 including, brightness, contrast, gain, etc. For example, the brightness control element 1210 may control gain of the IVUS image 1202. The zoom control element 1212 may control a diameter of an IVUS image 1202 displayed within the imaging interface 1200. In some embodiments, when the brightness control element 1210 or zoom control element 1212 are selected by a user, a slider control may be displayed.

[0196] Fig.12B illustrates an imaging interface 1200 according to one embodiment. The zoom control element 1212 may have been selected by a user, and the zoom slider control element 1220 may bedisplayed on the imaging interface 1200. In one embodiment, a position 1221 of the zoom slider control element 1220 is displayed to show a relative position, and can be manipulated by touch and / or voice. The slider control element 1220 may be disposed radially outside the zoom control element 1212. The user may move a control up and down the slider control element 1220 to adjust a zoom, i.e. a diameter of the IVUS image 1202.

[0197] Advantages of several embodiments of IVUS systems include a reduction or elimination of workflow difficulties, and a significant reduction of setup time, effort, and complexity for intraluminal measurements. In various embodiments, the IVUS systems provide intraluminal visualization to more precisely evaluate and effectively treat peripheral arterial and venous disease pre- and post- intervention. In various embodiments, the system is configured to measure luminal size (e.g., length and / or diameter to optimize stent and / or balloon sizing with precision to ensure proper wall apposition and to avoid compression or inadequate expansion), characterize disease morphology (e.g., lesion composition, such as measuring calcification or arterial / venous thrombi to assist with intervention and therapeutic planning and decisions), visualize dissections (e.g., 2D / 3D imaging with less reliance on angular specific imaging projection, and identification of presence and severity of dissections after atherectomy or PTA since irrespective of projection angle), locating and quantifying stenosis (e.g., providing complete intraluminal view that can reveal eccentric lesions and degree of occlusion as well as inform physician of distal and proximal landing zones), and / or identifying true lumen size (e.g., using cross-sectional images to navigate stenoses and chronic total occlusions (CTO) for recanalization either through true lumen or subintimal plane). The measurement interface may include a first element disposed in the left margin of the screen to the left of the IVUS image. The first element may provide an area for measurement details. The measurement interface may include a second element disposed in the right margin of the screen to the right of the IVUS image. The second element may provide a timeline and interactive recording navigation. The measurement interface may allow a user to zoom out to the summary interface.

[0198] The summary interface may provide a “zoom out” view that includes a summary of multiple images and associated measurements. For example, the zoom out view may include IVUS images in a four-by- four grid. The summary interface may allow a user to select an IVUS image, zoom in on a selected image, and / or change to the measurement screen for the selected image. In some embodiments, the IVUS images automatically selected and displayed in the summary interface. For example, the IVUS images may be selected by a machine learning model according to some embodiments. The IVUS images may select one or more IVUS images for display in the summary interface based one or more measurements performed on the IVUS images, a timeline event, and / or one or more annotations. For example, four IVUS images may be automatically displayed in the summary interface. In one embodiment, a summary interface comprises four images may include a first IVUS image captured at a first position in a lumen with a maximum diameter; a second IVUS image captured at a second position in the lumen with a minimum diameter; a third IVUS image captured at a third position in a lumen with an average diameter; and a fourth IVUS image captured at a clinical label event generated by clinician. In someembodiments, the at least one tablet 108 may determine a grammar context and a social cue context associated with a command. The ability to have a hands-free interaction with the IVUS system allows the clinician to interact with the system without breaking the sterile field according to one embodiment. In several embodiments, voice commands provide hands-free tasks and assist in measurement and real time border detection. A unique aspect of voice control can optionally utilize a select set of common system commands with a modernized workflow specific grammar context and social cue inference to allow for a wake-wordless command interaction to support a stream-lined imaging and measurement workflow. In several embodiments, hands-free commands and voice control uses a select set of common system commands with a workflow specific grammar context and social cue inference to allow for a wake-wordless command interaction to support a stream-lined imaging and measurement workflow. For example, a verbal command may be received after a period of silence. If the period of silence is greater than a silence threshold, a verbal command may be received and analyzed. If the verbal command is an acceptable verbal command, the command may be interpreted as a wake command, ending the period of silence. If the verbal command is not acceptable, the command may be ignored, and the system may resume the period of silence and wait to receive another verbal command. In another example, a voice command may start an annotation of an IVUS image. The annotation may be received through a physical or virtual keyboard, dictated through a microphone. The voice command may indicate a type of annotation to initiate such as an anatomical location annotation, a clinical label described below in conjunction with Figs.12-14. For example, the annotation may be one of a plurality of labels. The plurality of labels may include a plurality of preset labels and may be displayed as a drop-down list in a user interface.

[0199] In several embodiments, voice control of a component is configured for increased ease of setup of an IVUS system 100. The tablet 108 may transmit the command, the grammar context of the command, and / or the social cue context of the command to the workstation 106. In some embodiments, the tablet 108 may transmit the command to the workstation 106, and the workstation 106 may determine the grammar and social cue contexts associated with the one command.

[0200] For example, the clinician may use a “start” voice command to initiate the imaging via a user interface executed by the tablet. The start voice command may be a wake voice command as described herein. In another example, the clinician may initiate the IVUS procedure via the user interface on the tablet 108, e.g. by pressing a button on a touchscreen.

[0201] During an IVUS procedure, the processor may instruct the motor of the catheter interface module 104 to rotate the imaging core via the driveshaft. The imaging core may be instructed by the processor to capture a plurality of image lines. In some embodiments, the imaging core may be a single element ultrasound transducer. The imaging core may capture the plurality of image lines using pulse-echo emission and pulse-echo reception while the rotating single element ultrasound transducer spins about a length axis of the driveshaft. In some embodiments, the rotating single element transducer may collect the plurality of image lines in a high-fidelityformat without loss. The processor may store the plurality of images lines in the computer-readable memory in a custom format configured to maintain the high-fidelity format.

[0202] The processor may generate an IVUS image based on the plurality of images lines collected by the imaging core. The processor may generate the IVUS image in real time. In some embodiments, the processor may perform a multi-channel processing of the plurality of image lines to generate the IVUS image. Multi-channel processing may provide real time processing and image processing for the display of human interpretable images, while also processing for automated, computer based, image interpretation.

[0203] Multi-channel processing may combine data streams from multiple data sources. Using multi-channel processing, the processor may route data from a plurality of data sources, through a plurality of data processing pipelines, and route the IVUS image data to a plurality of data sinks. Data sources may be sensors, data sampling hardware, data generating sources (computations, simulations), etc. Each Data Processing Pipeline may have a unique set of processing operations or filters. Filters may have an input buffer, which can be a single data block or a series of data blocks. Filters can access all data blocks in the input buffer according to some embodiments. Each data processing pipeline may have an input rate and an output rate. The output rate of the pipeline may be a different rate than other pipelines according to some embodiments. For example, the raw ultrasound data pipeline may run at the native data capture frame rate of 30 Hz or 60 Hz, whereas image interpretation pipelines may run at the same frame rate or a lower frame rate. In some embodiments, image interpretation pipelines could use N frames and then have a lag, or may have a lag of N frames based on the series length. In some embodiments, image interpretation pipelines could run on a different frame rate (typically lower (down sampling) or on a higher frame rate (up sampling). Image interpretation pipeline outputs may result in the display update or may be aggregated in memory for later viewing.

[0204] Data sources, data processing pipelines, and data sinks may be connected by one or more data channels. Each data channel can include one or more data streams that are routed together through the infrastructure. Each data stream may include a series of data blocks. Data streams within a data channel share the same data block frequency but the data size per data stream can vary according to some embodiments. Data sinks may consume one or more data channels and utilize them individually or in combination. A data sink can also become a new data source which allows to daisy chain pipelines.

[0205] The data processing pipelines and data sinks may be configurable based on a functionality to be performed. The flexible configuration for the data sources, data processing pipelines, and / or the data sinks can optionally allow assembling the infrastructure at runtime and reuse of components and sub-components. In some embodiments, data channels may contain meta data associated with the properties of data being transmitted through the data channel. For example, a single data input block may be used for thrombus detection, plaque or calcium detection, stent apposition, blood flow analysis, etc. In another example, a plurality of input data blocks may be used for lumen diameter detection, dissection detection, etc.

[0206] In several embodiments, a registration mechanism between client to driver (e.g., user to kernel) is provided. In some embodiments, data processing pipelines may be registered by the processor. The registration protocol may include saving a process identification (PID) when a pipeline that’s created by a user- space driver is opened by a user-space process. The user-space driver may be executed by the processor. For example, a dissection detection pipeline may be registered after a user selects the dissection tool in a user interface. Saving the PID may include implicit registration of that process with a user-space driver that initiated the process. If the data processing infrastructure changes and / or different events happen (e.g. a new raw-cine block of a channel is available), the driver may send one or more unique signals to each of the processes that have registered. The registered processes may receive the signals and perform one or more computations related to the updated infrastructure and / or event. In some embodiments, the driver may allocate uncacheable memory in a kernel in one or more blocks for the registered process. For example, the processor may allocate uncacheable memory (e.g.64 GB, 128 GB, 256 GB or other values) in kernel in multiple chunks (e.g., 2 MB, 3 MB, 4 MB chunks, etc.). Advantageously, during ‘mmap’ time, when all these disparate memory-chunks are mapped into the virtual memory of a user-space process, they may be mapped contiguously. The processor may provide the IVUS image to be displayed on a display device. The processor may automatically orient the IVUS imaged based on anatomical signatures or defined landmarks in the imaging according to some embodiments. The user may manually orient the IVUS image via a user interface. Advantageously, enabling a user to reorient the IVUS image and / or automatically orienting the image can improve user experience by creating consistent image orientations for faster identification of anatomic location and identifying features in the image. Image orientation adjustment can optionally allow for user guided, or automated / auto-clocking of IVUS images based on anatomical signatures. In one embodiment, the user can rotate the frame orientation manually or use auto-clocking IVUS image based on anatomical signatures or defined landmarks in the imaging, which can improve user experience by creating consistent image orientations for faster identification of anatomic location and identifying features in the image. In some embodiments, the processor may provide the IVUS image to be displayed on the tablet 108. The processor may generate a longitudinal image based on a plurality of IVUS images. The longitudinal image may display a topography of a lumen across the plurality of images. In some embodiments, the longitudinal image may be generated based on a plurality of lumen diameter measurements calculated for the plurality of IVUS images. In some embodiments, the workstation 106 may include a display device, and the processor may provide the IVUS image to be displayed on the display device of the workstation 106. In some embodiments, the workstation 106 may be placed in electronic communication with external display device, and the processor may provide the IVUS image to be displayed on the external display device. For example, the processor may provide the IVUS image to be display on a television within the procedure room.

[0207] In some embodiments, the processor may perform edge-based machine learning computations associated with one or more of the plurality of image lines or the IVUS image. The processor maytrain the machine learning models using data analytics and / or native image collection. The processor may automatically identify plaque(s) within the imaged area. In some embodiments, the processor may utilize at least one machine learning model to identify a plaque. The machine learning model may identify a type of the plaque and / or suggest at least one treatment option. In some embodiments, the machine learning model may include a segmentation algorithm to segments at least one IVUS image based on at least one image threshold.

[0208] In some embodiments, the processor may detect a vessel border. In some embodiments, the processor may receive a command from the clinician, e.g. a voice command, and may detect the vessel border based on the user input. In several embodiments, real time and on-demand vessel border detection via processing power enables real time and on-demand vessel border detection. The border may be detected based on an IVUS image or a plurality of sequential IVUS images. Machine learning algorithms may analyze an IVUS image or a plurality of sequential IVUS images to detect the border according to some embodiments. The processor may provide for automated border detection of a vessel border for each ultrasound image frame. A border annotation of the may be displayed on top of the IVUS image within a user interface, identifying the detected border. The results of the border may be solely based on a single image or leverage adjacent images to provide confidence level for certain measures. In some embodiments, the processor may provide an automated “worst-case” stenosis identification.

[0209] In one embodiment, the processor may detect the vessel border using a detection algorithm. The detection algorithm can reduce the number of points for defining a border to 6-10 points (e.g., 6, 7, 8, 9, 10 points) by utilizing an interpolation. This can simplify for the user to manually modify the border points. The border points can have additional information about the confidence of the border detection. This can be used to color code areas where the user can focus on correcting the border or to not show the border and the user can manually add one or more points to complete the border drawing. Low confidence results can be rejected which may result in a sparsely sampled vessel border. In one embodiment, sample points are grouped into sectors of a specified angle to determine if a given sector is sufficiently sampled to represent an arc for that sector. The user can be presented with a spline-fit result of the vessel border only for sectors that are sufficiently sampled with high confidence points. Each sector may be represented by one or more control points such that the user may only need to interact with a small, manageable, number of points to adjust the vessel border if desired. In one embodiment, a display of a partial vessel border also allows the user to add one or more points to augment the automated border to complete the circumferential border.

[0210] The processor may provide a vessel border confidence indication that provides a confidence level of the detected vessel border (including a border segment). The confidence level may be calculated based on an IVUS image or a plurality of sequential IVUS images. For example, the processor may provide the detected vessel border as an overlay of an IVUS image. The detected vessel border overlay may include a plurality of color-coded confidence values, indicating the confidence level of the detected vessel borderat various locations. In some embodiments, the processor may receive an input from a user to adjust the detected vessel. For example, a user may “drag and drop” a portion of the detected vessel to a desired location. In some embodiments, the processor may update the vessel border confidence values based on the user input.

[0211] The processor may evaluate a placement and / or a quality of a stent placed within a lumen (e.g., to determine potential extent of stent apposition or stent malapposition). In some embodiments, the processor may assess a level of and / or a quality of tissue grown into and around the stent. Where a bioresorbable stent has been placed within a lumen, the processor may evaluate an amount of the stent that has been degraded. In some embodiments, the processor may determine a degradation pattern of the bioresorbable stent. The processor may determine whether the stent is degrading in an uneven fashion and / or a rate at which the bioresorbable stent is being degraded. The processor(s) may determine if the degradation rate is faster or slower relative to an expected degradation rate. If the degradation rate is greater than the expected degradation rate, the processor may recommend replacement of the stent.

[0212] The processor may measure aspects of the IVUS image such as a distance, an area, etc. which may be initiated automatically or manually. For example, a user may initiate a measurement via a measurement interface as described in conjunction with Fig.13 below. In some embodiments, the processor may detect irregularities. Detection of irregularities may be automatic according to some embodiments. For example, the processor may automatically detect a thrombus, plaque or calcium, stent apposition, a lumen diameter, dissection, etc. In some embodiments, the processor may determine a percent stenosis, a flow rate through a lumen, etc. The measurements made automatically by the processor may be customized by a user. For example, a user may select plaque detection and percent stenosis to be calculated by the processor automatically. The user may identify a potential dissection and manually instruct the processor to determine whether a dissection is present. In some embodiments, the measurements may be displayed by the processor on a display device, such as the workstation 106 and / or the at least one tablet 108. The measurements may be provided as an overlay on a user interface executed on the display device.

[0213] In several embodiments, IVUS imaging produces a 3D cross-sectional image of the vasculature. In one embodiment, combining absolute or relative position information across a series of images, referred to as a “pullback,” can be used to provide calibrated distance information across the 2D images. In several embodiments, combining an IVUS catheter with 3D position sensing technology allows an IVUS pull-back image series to be presented as a 3D reconstruction of the vasculature along with visualization of morphological assessment based on automated image measurements (e.g. vessel boundary, plaque, etc.). Once generated, the 3D vascular model can be displayed as a 2D projection similar to a 2D fluoroscopic image (or angiography). In one embodiment, a simplified sensing approach could be adopted that provides positional information in a 2D plane (A-P view). In several embodiments, 3D imaging and modelling includes for example, a volumetric representation of tissue or a lumen. In some embodiments, 3D imaging is reconstructed via algorithms interpolatinga series of 2D images across a third dimension, taking a series of individual 2D images and estimating linear progression along the third dimension, and employing AI to produce a 3D volumetric representation of the interpolated 2D images. In one embodiment, one or more algorithms convert series of IVUS 2D images and signal data into volumetric 3D visualization. In one embodiment, 3D visualization is produced via interpolation of linear and / or nonlinear vascular structure geometry and acoustic reflections from a tissue. In one embodiment, pixel based interpolation is used to visualize vascular anatomy in three dimensions. In several embodiments, a series of cross sectional two dimensional IVUS images and / or signals are generated via pixel based cut view images of a vessel showing acoustic reflection information along a length of a lumen. In one embodiment, 3D visualization is produced via algorithms for creating anatomical contour borders via smooth 3D surface rendering. In several embodiments, AI is employed to create 3D visualization data and images.

[0214] The processor may produce a 2D cross-section IVUS image of the lumen. In some embodiments, the processor may create a pullback recording which may include a plurality of 2D IVUS images captured as the IVUS catheter traverses in the longitudinal direction through the lumen. A pullback recording may be captured while the IVUS catheter moves proximally or distally in the longitudinal direction. The processor may associate the pullback recording with a position of the catheter. The position of the IVUS catheter may be defined relative to an anatomical point. The processor may generate a 3D reconstruction of the lumen during a pullback recording. The 3D reconstruction may be generated by combining the IVUS image data and a recorded position of the catheter in the longitudinal direction. The position of the IVUS catheter may be detected one or more sensors, such as an electromagnetic sensor. In some embodiments, the 3D reconstruction may be displayed as a 2D projection similar to a 2D fluoroscopic image. The 3D reconstruction may be color-coded based on one or more measurements or analyses performed on an IVUS image or a plurality of IVUS images. The color-coding may be generated as an overlay on the 3D reconstruction in real time and / or retrospectively. For example, a detected plaque may be shown in a first color, a dissection may be shown in a second color, a false lumen may be shown in a third color, and a % stenosis may be overlayed on the 3D reconstruction. In one embodiment, AI plaque identification utilizes AI algorithms to automatically classify and identify types of plaque within the imaged area to provide user guidance on treatment options (e.g., using color coding, icons or text overlays can be used to indicate what type of condition, such as plaque, may be present for the selected image).

[0215] In some embodiments, the processor may automatically generate a procedure report during or after procedure such as an IVUS procedure. The report may be edited during a procedure according to some embodiments. The report may include: a patient history, a patient identifier, time stamp(s), manual and automated measurements, stenosis computations, cross-frame metrics such as blood flow and lumen diameter, manual and automatic annotations, time-sequence summaries, and / or notes provided by a user. In one embodiment, compound measurements include computation of cross-frame and cross-recording metrics such as blockage to provide guidance to a clinician and procedure reporting. Measurements may include compound measurementstaken using an image such as an IVUS image or a plurality of IVUS images. For example, a measurement may include percent stenosis of a vessel.

[0216] In some embodiments, the processor may analyze the need for service and / or replacement of components of the IVUS system 100. The processor may analyze system metrics and identify a current or anticipated need for maintenance or replacement of a component. In some embodiments, the processor may recommend a service time or automatically schedule a service appointment to maximize system availability and uptime. In some embodiments, data about the lifespan and use of the components may be analyzed by the processor to identify areas for improvement. In some embodiments, the analysis and service recommendations may be performed by a remote server, e.g. a cloud server, in communication with the IVUS system 100.

[0217] In some embodiments, the IVUS system 100 may include a cloud storage system. The processor may upload / store IVUS procedure information in the cloud storage system. For example, the processor may store the plurality of images, a plurality of IVUS images generated during the procedure, catheter information, etc. in the cloud server. In some embodiments, the cloud storage system may train the machine learning models described herein (e.g., based on annotations or adjustments to automated output received from multiple clinicians at one or more locations).

[0218] Figs. 13A, 13B, and 13C illustrate a measurement interface 1300 according to several embodiments. Similar to the imaging interface 1200, the measurement interface 1300 may be a touch-user interface. The measurement interface 1300 may be generated on a tablet, such as a tablet. A user may interact with the one or more elements of the measurement interface 1300 by touching the element(s) on a screen. In some embodiments, the measurement interface 1300 may be a voice user interface and may receive voice commands via a microphone. The measurement interface 1300 may receive both touch and voice commands from a user. In several embodiments, the IVUS system can include real time measurement timeline overlay capabilities, such as improving navigation of recorded datasets by utilizing overlays based on real time measurements to allow user to quickly find regions of interest. Overlays could be based on maximum / minimum / average diameters on the frame, and / or lumen area and variations of area such as perimeter or circumference. The user can customize which metrics are used on the overlay or create user preferences to persist settings for future procedures. In one embodiment, cross-sectional thumbnails can be used. In one embodiment, cross-sectional thumbnails are not used.

[0219] The measurement interface 1300 may display a recording of a plurality of IVUS images 1302. In some embodiments, the measurement interface 1300 may display a live IVUS image 1302. The measurement interface may include a live image element 1304, a label element 1306, a screen capture element 1308, a length measurement element 1310, an area measurement element 1312, an automation element 1313 (e.g., to initiate AI automated measurements and / or capabilities), a brightness control element 1314, and / or a zoom control element 1316. The measurement interface 1300 may include a measurement summary element1318, a IVUS image loop element 1320, and / or a timeline element 1322. In one embodiment, a position 1323 of the timeline element 1322 is displayed to show a relative time (e.g., time, image frame in a series of images, position, etc.) and can be manipulated by touch and / or voice.

[0220] The label element 1306 may create a label for the IVUS image 1302. The label for the IVUS image may be a clinical label. Clinical labels may be diagnostic or structural labels provided by a medical professional. For example, a clinical label may include a dissection, a thrombus, a plaque including, in some embodiments, a type of plaque. the clinical label for the IVUS image 1302 may generate a clinical label event 1324 in the timeline element 1322 according to some embodiments. The timeline event may be created based on a type of label created for the IVUS image 1302. For example, a clinical label event may be shown in a first color, e.g. purple. In some embodiments, the label element 1306 may be selected with a voice command. The measurement interface 1300 may prompt a user to enter the clinical label via a voice command. In some embodiments, a user may scroll through the timeline, and a device executing the measurement interface 1300 may provide a feedback to the user when they reach timeline event, such as a haptic feedback, an audio feedback, and / or a visual feedback. In some embodiments, the user may select timeline events to be displayed on the timeline element 1322. For example, the user may select only clinical label events to be displayed. For example, in some embodiments, a haptic feedback may be provided when a user enters a touch input to select an element of a touch user interface, can incorporate haptic feedback to provide user feedback when the user interacts with the UI through the tablet, and / or use haptic feedback when scrubbing over the timeline to indicate where a tissue lumen diameter is a certain value, changing, maximized, and / or minimal.

[0221] The measurement interface 1300 may include a length measurement element 1310. A user may select the length measurement element 1310. Selection of the length measurement element 1310 may cause the measurement summary element 1318 to be displayed. A user may initiate a measurement with a touch command. The measurement interface 1300 may receive the touch command and generate a first measurement point 1326. For example, a user may touch the measurement interface 1300 at a first point 1328, and the measurement interface 1300 may generate the first point 1328 on the IVUS image 1302. A user may generate a measurement by entering a second touch command. The measurement interface 1300 may generate a second point 1330, as shown in Fig.13B. The measurement interface 1300 may connect the first point 1328 and the second point 1330, calculating the distance between the two according to some embodiments. As shown in Fig. 13B, the measurement summary element 1318 may be updated and display the distance between the first point 1326 and the second point 1328. The measurement summary element 1318 may include a delete measurement element 1332 and / or a hide measurement element 1334. In some embodiments, calculation of the measurement may generate a measurement event 1336 on the timeline element 1322 as shown in Fig. 13C. In some embodiments, the measurement event 1336 may be displayed in a second color. The second color may bedifferentiated from a first color associated with a clinical label event 1324. For example, the first color may be purple, and the second color may be yellow.

[0222] The measurement interface 1300 may include an area measurement element 1312. A user may select the area measurement element 1312. Similar to the length measurement inputs, the user may input a plurality of points, e.g. a first point 1338, a second point 1340, a third point 1342, a fourth point 1344, and a fifth point 1346. For example, the plurality of points may be placed around a vessel lumen in the IVUS image 1302. The measurement interface 1300 may estimate a shape based on the plurality of points. For example, the measurement interface 1300 may calculate a “best fit” ellipse and / or spline based on the plurality of points. In some embodiments, the measurement interface 1300 may determine a confluence of the estimated shape 1348. The measurement interface 1300 may determine the confluence with radial sampling. If the confluence does not meet the threshold, the measurement interface 1300 may prompt the user to enter one or more additional points.

[0223] If the confluence exceeds a confluence threshold, the measurement interface 1300 may display the estimated shape 1348. A measurement timeline event, e.g.1336 may be generated on the timeline element 1322. The measurement summary element 1318 may be updated to display one or measurements associated with the estimated shape 1348. The measurements may include an area of the estimated shape 1348, an average diameter of the estimated shape 1348, a minimum diameter of the estimated shape 1348, and / or a maximum diameter of the estimated shape 1348. The measurement summary element 1318 may include a lock element 1350 and / or an add point element 1352. The lock element 1350 may prevent the plurality of points from being moved, the addition to and / or subtraction from the plurality of points. The lock element 1350 may maintain the area measurement as an overlay on each of the plurality of images being reviewed. The persistence of the area measurement may enable cross-image comparisons for area measurements used to automatically compute a percent difference in area or a percent difference in diameter between a locked area measurement on a first image and a measurement on another image of a plurality of images being reviewed. A user may add or subtract points from the plurality of points and / or reposition one or more of the plurality of points, e.g. by selecting the add point element 1352 and entering a touch command on the IVUS image 1302. The measurement interface 1300 may update the estimated shape based on the changes made by the user. In some embodiments, a user may interact with the area measurement element 1312 via a voice command.

[0224] The measurement interface 1300 may include an automation element 1313. The automation element 1313 may initiate AI automated measurements and / or capabilities. For example, the automation element 1313 may initiate automatic calculation of one or more measurements. The one or more measurements may include a maximum diameter, a minimum diameter, and / or an average diameter of a lumen, such as a vascular lumen. The maximum diameter, minimum diameter and / or average diameter of the lumen may be calculated based on one or more IVUS images. For example, the maximum diameter, minimum diameter, and average diameter may be calculated for one IVUS image of a vascular lumen with an atherosclerotic plaque. Inanother example, the maximum diameter, minimum diameter, and average diameter may be calculated for a plurality of IVUS images captured as the IVUS catheter moves longitudinally through the lumen, such as during a pullback maneuver. The average diameter may be computed by averaging the minimum and maximum diameter measurements, or from computing the diameter based on the area and / or a circumference measurement, for example.

[0225] The automation element 1313 may initiate automatic identification of one or more irregularities according to some embodiments. The workstation 106 and / or the tablet 108 may process one or more IVUS images using a machine learning model to identify one or more irregularities captured in the one or more IVUS images. The one or more irregularities may include lesions, thrombus, aneurysm, dissection, plaque (e.g., hard plaque, soft plaque, vulnerable plaque, calcified plaque, substantially non-calcified plaque, fibro-fatty plaque), thrombus, fistulas, tumors, neoplasia, gallstones, kidney stones, polyps, cysts, etc., and measuring morphology assessment wherein such irregularities are within vessels, other bodily lumens or other target sites. In several embodiments, irregularities may also include stent or balloon malapposition, post-atherectomy dissection, determining etiology of compression, under-expansion of a stent or other device, and issues with IVUS- guided sizing and grading of severity of an irregularity or under expansion of a stent, such as an iliac vein stent. In some embodiments, a machine learning model may be trained to detect a plurality of irregularities. In some embodiments, a plurality of machine learning models may each be trained to detect one or more irregularities. The plurality of machine learning models may be executed in parallel or sequentially to identify the one or more irregularities. In some embodiments, a first machine learning model may be used to determine a genus of irregularity, and a second machine learning model may be used to identify a species of irregularity. This may be done for a plurality of IVUS images captured as the IVUS catheter moves longitudinally through the lumen, such as during a pullback or catheter movement maneuver, or selectively for an image of interest. Tumors include, for example, fibroids, polyps, abnormal cell clusters, etc. and may be benign or cancerous, including but not limited to those located in reproductive organs such as the uterus, the nasal or ear cavity, rectum, colon, other intestinal regions or elsewhere.

[0226] A graphical representation of the one or more irregularities may be provided for display on one or more IVUS images. The graphical representation may be provided as an overlay on the one or more IVUS images and may highlight the one or more identified irregularities. The graphical representation may include a type of each irregularity, a genus of each irregularity, a species of each irregularity, a dimension of each irregularity, a plurality of treatment options for each irregularity, and / or a suggested treatment for each irregularity. In some embodiments, the graphical representation may highlight a border of each irregularity as an overlay on the IVUS image. In another embodiment, the graphical representation may highlight each irregularity as an overlay or colored region on the 2D or 3D timeline.

[0227] The automation element 1313 may initiate automatic identification of a border of a vascular lumen imaged by the IVUS catheter. As discussed herein, a vessel border may be detected based on an IVUS image or a plurality of sequential IVUS images. Machine learning algorithms may analyze an IVUS image or a plurality of sequential IVUS images to detect the border according to some embodiments. The Machine learning model may be trained broadly using IVUS images from one more manufacturers or sources and from one or more imaging frequencies to provide a robust training set with variation in image resolution and depth of penetration. The Machine learning model may also be trained with lumens from both venous and arterial IVUS images (e.g., from the device and / or one or more sources) to provide a robust detection of the lumen when plaque or thrombus is present. Broadly training a model can also be applied to train a Machine learning model to detect irregularities. A graphical representation of the vascular lumen border, e.g. a border annotation, may be displayed on top of the IVUS image within the measurement interface 1300, identifying the detected border. The results of the border may be solely based on a single image or leverage adjacent images to provide confidence level for certain measures. In some embodiments, an automated “worst-case” stenosis identification may be determined and provided, for example, when analyzing a complete “pullback”.

[0228] A number of image interpretation algorithms may be active during a “pullback” and may detect vascular features beyond the lumen of interest. In some embodiments, side branches and / or collateral vessels are identified. In another embodiment, collateral vessels are identified and tracked during the “pullback”. Collateral vessel tracking and visualization may assist in, and increase the confidence of, lumen identification when the collateral vessel is becomes in close proximity to the lumen of interest leading to insufficient imaging data to disambiguate each vessel when solely viewing a single image or even adjacent images. Existence of side branches and collateral vessels may also be graphically depicted on the timeline as an overlay or color coded graphic, and may also be shown as a 3D depiction along with the lumen of interest. The 3D depiction may be shown in a linearized fashion in an (X,Y,Z) coordinate frame where Z is the longitudinal axis, and the center of the catheter is locked to (X=0, Y=0) coordinate. The 3D depiction may be shown in a coordinate frame (X,Y,Z) where the center of the catheter is not locked to (X=0, Y=0) coordinate.

[0229] In one embodiment, the workstation 106 or the tablet 108 may detect the vessel border using a detection algorithm. The detection algorithm can reduce the number of points for defining a border to 6-10 points (e.g., 6, 7, 8, 9, 10 points) by utilizing an interpolation. This can simplify for the user to manually modify the border points by reducing the number of interaction points and providing sufficient point separation for simplified touch screen interaction. The border points can have additional information about the confidence of the border detection. This can be used to color code areas where the user can focus on correcting the border or to not show the border and the user can manually add one or more points to complete the border drawing. Low confidence results can be rejected which may result in a sparsely sampled vessel border. In one embodiment, sample points are grouped into sectors of a specified angle to determine if a given sector is sufficiently sampled to represent anarc for that sector. The user can be presented with a spline-fit result of the vessel border only for sectors that are sufficiently sampled with high confidence points. Each sector may be represented by one or more control points such that the user may only need to interact with a small, manageable, number of points to adjust the vessel border if desired. In one embodiment, a display of a partial vessel border also allows the user to add one or more points to augment the automated border to complete the circumferential border.

[0230] A confidence indication illustrating a confidence level of the detected vessel border may be provided. The confidence level may be calculated based on an IVUS image or a plurality of sequential IVUS images. For example, the processor may provide the detected vessel border as an overlay of an IVUS image. The detected vessel border overlay may include a plurality of color-coded confidence values, indicating the confidence level of the detected vessel border at various locations. In some embodiments, the processor may receive an input from a user to adjust the detected vessel. For example, a user may “drag and drop” a portion of the detected vessel to a desired location. In some embodiments, the processor may update the vessel border confidence values based on the user input.Figs.14A and 14B illustrate a summary interface 1400 according to one embodiment. As shown in Fig.14A, the summary interface 1400 may provide a Summary View that includes a summary of select images and associated measurements.

[0231] In one embodiment, a measurement summary screen provides a summary of select images and associated measurements (e.g., 1x1, 2x2, 4x4, 4x2, m x n, etc.) and the ability to show snapshots and summaries for a single image. In several embodiments, the IVUS system allows the user to toggle to a summary view one or more of a recording (e.g. a “pullback” recording), and one or more bookmarked images, one or more images with measurements, one or more images that have been labeled, and one or more images that have been saved (e.g., 1x1, 2x2, 4x4, 4x2, m x n, etc.) within a procedure. In one embodiment, the order of the images presented appear in the chronological order of the user interaction (bookmarked, measured, labeled, saved). In another embodiment, images are viewable and grouped by a recording (e.g. a “pullback” recording), and the user can select the recording context of the summary. In another embodiment, the user will see all images across a procedure and can scroll through the images in a grid view, such as a 1x1, 2x2, 4x4, 4x2, or m x n grid. In another embodiment the user can re-order the images the order of preference, or automatically based on anatomical order based on image labels. The user can view multiple images at the same time or zoom into a single view for additional details. This feature allows for seamless viewing or editing of measurements. For example, the zoom out view may include IVUS images in a grid, such as a two-by-two grid, a four-by-four grid, a four-by-two grid, an m x n, etc. The grid may be dimensioned based on a size of a display. The summary interface 1400 may include a menu 1402. The menu 1402 may be a drop-down menu as shown in Fig.14B. The menu 1402 may display a list of images, recordings, labels, measurements, and / or different IVUS procedures associated with a patient. The user may select items from the menu 1402 to be displayed in the summary interface 1402. For example, a user may select a first image 1404, a second image 1406, a third image 1408, and a fourth image 1410.

[0232] In some embodiments, the IVUS images automatically selected and displayed in the summary interface. For example, the IVUS images may be selected by a machine learning model according to some embodiments. The IVUS images may select one or more IVUS images for display in the summary interface based one or more measurements performed on the IVUS images, a timeline event, and / or one or more annotations, or user explicit selection. For example, four IVUS images may be automatically displayed in the summary interface. The four images may include a first IVUS image captured at a first position in a lumen with a maximum diameter; a second IVUS image captured at a second position in the lumen with a minimum diameter; a third IVUS image captured at a third position in a lumen with an average diameter; and a fourth IVUS image captured at a clinical label event generated by clinician. One of the displayed images may represent the plurality of images saved in a “pullback”, with one or more images from the “pullback”.

[0233] In various embodiments, the summary interface 1400 may include one or more image summary elements 1412. The image summary elements 1412 may include measurements, labels, data, information (e.g., area, length, dimension, % occlusion, blood flow, rates, time, date, and / or maximum / minimum / average of any of the foregoing, etc.) for each of image or multiple images / video displayed in the summary interface 1400. For example, the image summary element 1412 may include the two area measurements and the length measurement associated with the first image 1404. The summary interface 1400 may allow a user to select an IVUS image, e.g. the first image 1404, and display the image in an image summary view, which is shown in Fig.14B according to one embodiment. The image summary view may include elements similar to the measurement interface 1300, e.g. a label element, a screen capture element, a length measurement element, an area measurement element, a brightness control element, a zoom control element, etc. The user may edit one or more measurements within the selected image. For example, a user may add measurements, delete measurements, or make changes to one or more points of a length measurement or an area measurement.

[0234] In one embodiment, a command may be to start an annotation. In one embodiment, an annotation may be triggered by pressing a microphone button 1218 on the user interface, or verbally stating a command such as “annotate”. Annotations can be either manually entered through typing on a physical or virtual keyboard or dictated and transcribed using voice-to-text processing. The type of command could indicate the type of annotation to initiate. In some cases, the annotation could be a simple label which could be constrained to a specific list of options similar to a drop-down list in a graphical user interface.

[0235] In several embodiments, an interface with two or more images of interest are displayed and the user can initiate compound measurements across the two or more images. In one embodiment, compound measurements may include % area reduction and / or % stenosis. In one embodiment, one more selected images can be labeled with clinically relevant annotations via a touch keypad or voice. In several embodiments, a report summary provides documentation for a treatment, wherein a report can be sent to a connected to lab IT systems for patient records.IVUS Image Processing and Analysis

[0236] Fig.15 illustrates a multi-channel process 1500 according to one embodiment. The multi- channel process 1500 may include a plurality of data sources 1502, a plurality of data processing pipelines 1504, and / or a plurality of data sinks 1506. The data source(s) 1502, the data processing pipeline(s) 1504, and the data sink(s) 1506 may be connected by a plurality of data channels 1508. Data sources 1502 may be sensors, data sampling hardware, data generating sources (computations, simulations), etc. Each data processing pipeline 1504 may have a unique set of processing operations or filters. Filters may have an input buffer, which can be a single data block or a series of data blocks. Filters can access all data blocks in the input buffer according to some embodiments. Each data processing pipeline may have an input rate and an output rate. The output rate of the pipeline may be a different rate than other pipelines according to some embodiments. For example, the raw ultrasound data pipeline may run at the native data capture frame rate of 30 Hz or 60 Hz, whereas image interpretation pipelines may run at a lower frame rate and may have a lag of N frames based on the series length. Image interpretation pipeline outputs may result in the display update or may be aggregated in memory for later viewing.

[0237] Data sources 1502, data processing pipelines 1504, and data sinks 1506 may connected by one or more data channels 1508. Each data channel 1508 can include one or more data streams that are routed together through the infrastructure. Each data stream may include a series of data blocks. Data streams within a data channel 1508 share the same data block frequency but the data size per data stream can vary according to some embodiments. Data sinks 1506 may consume one or more data channels and utilize them individually or in combination. A data sink 1506 can also become a new data source which allows to daisy chain pipelines.

[0238] The data processing pipelines 1504 and data sinks 1506 may be configurable based on a functionality to be performed. The flexible configuration for the data sources 1502, data processing pipelines 1504, and / or the data sinks 1506 can allow for assembling the infrastructure at runtime and reuse of components and sub-components. In some embodiments, data channels 1508 may contain meta data associated with the properties of data being transmitted through the data channel. For example, a single data input block may be used for thrombus detection, plaque or calcium detection, stent apposition, blood flow analysis, etc. In another example, a plurality of input data blocks may be used for lumen diameter detection, dissection detection, etc.

[0239] Fig.16A illustrates a plurality of data channels 1602 according to some embodiments. Each data channel may include one or more data streams 1604. The data stream(s) 1604 may transmit one or more data blocks 1606.

[0240] Fig. 16B illustrates a plurality of data processing pipelines 1608 according to one embodiment. The data processing pipeline 1608 may include one or more filters 1610. The filter(s) 1610 may include at least one input buffer 1612. The input buffer 1612 may include one or more data blocks 1614. The output of the data processing pipeline 1608 may provide data at an output rate. The output rate may be the same as ordifferent another data processing pipeline. For example, a raw ultrasound data pipeline may run at a capture rate of the IVUS catheter, e.g.30 Hz or 60 Hz. An image interpretation pipeline may run at a lower frame rate and may have a lag of N frames based on a length of a series of IVUS images.

[0241] Fig. 17 illustrates a multi-channel IVUS image infrastructure 1700 according to one embodiment. The multi-channel IVUS image infrastructure 1700 may include one or more data sources, one or more data processing pipelines, and one or more data sinks. The one or more data sources may include a plurality of raw ultrasound data frames 1702. The data processing pipelines may include a raw ultrasound data processing pipeline 1704, an automatic lumen detection pipeline 1706, and / or a dissection detection pipeline 1708. The raw ultrasound data processing pipeline 1704 may process the raw ultrasound frames to create a plurality of ultrasound data frames 1710. The automatic lumen detection pipeline 1706 may automatically detect one or more of an average lumen diameter, a maximum lumen diameter, and / or a minimum lumen diameter, which may be provided as lumen boundary data 1712. The dissection detection pipeline 1708 may identify a dissection of a vessel and provide dissection data 1714. The ultrasound data frames 1710, the lumen boundary data 1712, and / or the dissection data 1714 may be provided to a data sink and displayed on a display device 1718, such as a tablet. In some embodiments, data may be overlayed on an IVUS image. For example, a dissection may be highlighted via an overlay. In another example, the lumen boundary data may be overlayed on a display above an IVUS image. In one embodiment, multi-channel processing pipeline is configured synchronous to ultrasound acquisition timing, via decimated by N periods to allow processed aggregated data blocks.

[0242] Fig.18 illustrates a process 1800 for receiving and processing a voice command according to one embodiment. An IVUS system may receive voice commands from at least one clinician according to some embodiments, e.g. through a workstation, tablet, and / or tablet mount. The voice command may control an IVUS catheter (e.g., to start and / or stop imaging, etc.), be used to navigate a user interface, and analyze IVUS images through measurements, detection of irregularities, annotations, and labels. In several embodiments, hands-free commands may belong to a select set of common system commands with a workflow specific grammar context and social cue inference. In some embodiments, processor of a receiving device may determine a grammar context and / or a social cue context associated with the command.

[0243] The verbal commands may allow for a wake-wordless command interaction to support a stream-lined imaging and measurement workflow. In some embodiments, the grammar and / or social cue context may wake a system after a period of silence. For example, a verbal command may be received after a period of silence. In some embodiments, the readiness of the system to receive a command may be visually shown on the user interface. Visual feedback allows the user to adapt verbal behavior on the system readiness status and maximize success of verbal command interaction. If the period of silence is greater than a silence threshold, a verbal command may be received and analyzed. If the verbal command is an acceptable verbal command, the social cue may be interpreted as a wake command, ending the period of silence. If the verbal command is notacceptable, the command may be ignored, and the system may resume the period of silence and wait to receive another verbal command. A visual status of the failed attempt to process a verbal command may be shown visually to the user. In another example, a voice command may start an annotation of an IVUS image. The annotation may be received through a physical or virtual keyboard, dictated through a microphone. The voice command may indicate a type of annotation to initiate such as an anatomical location annotation, a clinical label described herein in conjunction with Figs.12-14. For example, the annotation may be one of a plurality of labels. The plurality of labels may include a plurality of presets and may be displayed as a drop-down list in a user interface. Advantageously, the voice command process 1800 optionally allows a clinician to control aspects of the IVUS system without breaking the sterile field.

[0244] Fig.19 illustrates a process 1900 for receiving and processing a voice command according to one embodiment. The process 1900 illustrates how a voice command may be received from a speaker, analyzed, and used to wake an IVUS system after a period of silence or disengagement. The process 1900 shows how some verbal commands may be accepted or ignored by an IVUS system 1902 in a manner that allows a clinician 1904 to communicate with another person 1906 without inadvertently entering a verbal command.

[0245] Fig.20 illustrates a process 2000 for vessel border detection according to one embodiment. The process 2000 may begin by retrieving one or more IVUS image frames 2002. The process 2000 may move to step 2004 where a vessel boundary may be detected. The vessel boundary may be detected based on manual inputs according to some embodiments. In some embodiments, the vessel boundary may be detected using one or more boundary detection algorithms. The boundary detection algorithm may be an AI and / or machine learning algorithm. The ...

Claims

CLAIMS WHAT IS CLAIMED IS:

1. An intravascular ultrasound imaging system comprising: an intravascular ultrasound (IVUS) catheter comprising a catheter lumen and an imaging core; a catheter interface module comprising a motor; and a processor, wherein the imaging core comprises a single element ultrasound transducer, wherein the imaging core is configured to rotate within the catheter lumen; wherein the catheter interface module is configured for mechanical and electrical connection to the IVUS catheter, wherein the motor is configured to rotate the imaging core within the catheter lumen; and wherein the processor is configured to: automatically calculate one or more measurements of a vascular lumen from an IVUS image imaged by the imaging core, automatically identify an edge of the vascular lumen; calculate one or more confidence values associated with one or more sections of the edge of the vascular lumen; and provide a graphical representation of the edge of the vascular lumen to be displayed in real time as an overlay on the IVUS image, wherein the graphical representation of the edge of the vascular lumen is divided into the one or more sections of the edge of the vascular lumen based on the one or more confidence values associated with each of the one or more sections of the edge of the vascular lumen.

2. The intravascular ultrasound imaging system of claim 1, wherein the one or more measurements are selected from the group consisting of: a maximum diameter of the vascular lumen, a minimum diameter of the vascular lumen, and an average diameter of the vascular lumen.

3. The intravascular ultrasound imaging system of claim 1, wherein the processor is configured to detect the edge of the vascular lumen using a detection algorithm interpolating a plurality of points on the graphical representation of the edge of the vascular lumen.

4. The intravascular ultrasound imaging system of claim 1, wherein the processor is configured to display a confidence indicator based on the one or more confidence values.

5. The intravascular ultrasound imaging system of claim 4, wherein the confidence indicator is a color-coded confidence value located on the one or more sections of the edge of the vascular lumen.

6. The intravascular ultrasound imaging system of any one of claims 1-5, wherein the processor is configured for image analysis using an artificial intelligence algorithm to identify at least one of a vessel lumen and a vessel border.

7. The intravascular ultrasound imaging system of any one of claims 1-5, wherein the processor is configured for image analysis using an artificial intelligence algorithm to identify blood or a location or a type of at least one of plaque, thrombus, calcium, and vessel dissection in a peripheral vascular system.

8. The intravascular ultrasound imaging system of any one of claims 1-5, wherein the processor is configured for real time multi-channel processing and image processing for a display of human interpretable images, while also processing for automated, computer-based, image interpretation.

9. The intravascular ultrasound imaging system of any one of claims 1-5, wherein the processor is configured for classifying tissue or abnormality type for one or more locations of interest in a vessel of a patient, wherein the processor is configured to: receive intravascular ultrasound image data of the vessel of the patient; extract patient-specific vessel geometry of the patient from the intravascular ultrasound image data; extract geometric features from the patient-specific vessel geometry of the patient; and classify different types of tissue for one or more locations of interest in the vessel based on extracted geometric features using a trained machine-learning based model trained based on intravascular ultrasound images obtained from intravascular ultrasound catheters operating at different frequencies and based on intravascular ultrasound images of multiple different types of vessels.

10. The intravascular ultrasound imaging system of claim 9, further comprising: generating an output for display on a graphical user interface that indicates the different types of tissue or abnormalities; generating a confidence measure associated with the classifying, and outputting the confidence measure on a display of the graphical user interface, wherein the tissue or abnormality type is selected from the group consisting of one more of the following: intima, media, adventitia, lumen, blood, thrombus, tumor, plaque, and calcium.

11. The intravascular ultrasound imaging system of any one of claims 1-5, wherein the processor is configured for assessing a vessel of a patient, wherein the processor is configured to: receive intravascular ultrasound image data of the vessel of the patient; extract information from the intravascular ultrasound image data of the vessel of the patient; store the information in memory; and classify different types of tissues or abnormalities for one or more locations of interest in the vessel based on the extracted and stored information using a trained machine-learning based model thatis trained based on intravascular ultrasound images obtained from intravascular ultrasound catheters operating at different frequencies and based on intravascular ultrasound images of multiple different types of vessels.

12. The intravascular ultrasound imaging system of claim 11, further comprising: generating an output for display on a graphical user interface that indicates the different types of tissue; generating a confidence measure associated with the classifying, and outputting the confidence measure on a display of the graphical user interface, wherein the types of tissues or abnormalities are selected from the group consisting of one more of the following: intima, media, adventitia, lumen, blood, thrombus, tumor, plaque, and calcium.

13. The intravascular ultrasound imaging system of any one of claims 1-5, wherein the processor is configured for assessing a vessel of a patient, wherein the processor is configured to: receive one or more intravascular ultrasound images of the vessel of the patient; extract data from the one or more intravascular ultrasound images; store the data in memory; perform a vessel feature detection task on the extracted and stored data using a machine learning based model trained to detect at least a first vessel feature in intravascular ultrasound image data, wherein performing the vessel feature detection task comprises generating an automated output associated with the first vessel feature; and utilize the automated output associated with the first vessel feature, performing a tissue or abnormality classification task using a machine learning model trained to classify tissue in the one or more intravascular ultrasound images, wherein performing the tissue classification task comprises generating an automated result of the tissue classification task.

14. The intravascular ultrasound imaging system of claim 13, wherein the extracted data includes amplitude and phase data, wherein the first vessel feature is a lumen boundary and the vessel feature detection task is detection of the lumen boundary, wherein the automated output associated with the first vessel feature is graphical output of the lumen boundary, and wherein the tissue or abnormality classification task includes classifying blood, plaque, or calcium.

15. The intravascular ultrasound imaging system of any one of claims 1-5, further comprising: a tablet, wherein the tablet is configured to receive at least one input from a user,a tablet mount comprising one or more microphones, an electrical contact, a first tablet mount interface, and a second tablet mount interface, and a workstation configured for electrical connection to the catheter interface module, wherein the catheter interface module is configured for removable mechanical connection to a catheter interface module mounting surface on a patient chassis, wherein the one or more microphones is configured to receive a verbal command from a voice of the user, wherein the one or more microphones is configured to be placed in communication with the tablet, wherein the first tablet mount interface is configured for connecting to the tablet via a releasably attachable interface, wherein the releasably attachable interface comprises a latch, wherein the second tablet mount interface is configured for removable mechanical connection to at least one of: a mounting surface on the patient chassis, a mobile cart, an articulating mount, and a universal mount.

16. The intravascular ultrasound imaging system of claim 15 is further configured to: identify a direction of the verbal command, determine whether the direction of the verbal command is from a known position of a user; and transmit the verbal command to the workstation in response to determining that the direction of the verbal command in the direction of the verbal command is from the known position of the user.

17. A method of intravascular ultrasound imaging, the method comprising: receiving an intravascular ultrasound (IVUS) image of a tissue from a rotating imaging core in an IVUS catheter lumen; automatically identifying an edge of a tissue in the IVUS image; calculating one or more confidence values associated with one or more sections of the edge of the tissue; and providing a graphical representation of the edge of the tissue to be displayed as an overlay on the IVUS image in real time, wherein the graphical representation is divided into the one or more sections of the edge of the tissue with a confidence indicator in real time based on the one or more confidence values associated with each of the one or more sections of the edge of the tissue.

18. The method of claim 17, further comprising: receiving an input from a user, modifying a custom edge of the tissue based on the input from the user; and updating the graphical representation of the edge of the tissue further comprising the custom edge.

19. The method of claim 17, further comprising performing machine learning computations associated with the IVUS image to train the identifying the edge of the tissue in the IVUS image.

20. The method of claim 17, wherein the tissue comprises a blood vessel.

21. The method of claim 17, further comprising receiving a user input and detecting the edge of the tissue based on the user input.

22. The method of claim 17, further comprising performing, via one or more processors, a multi-channel processing of the IVUS image.

23. The method of claim 22, wherein the multi-channel processing provides real time processing and image processing for the display of human interpretable images, while also processing for automated, computer- based image interpretation.

24. The method of any one of claims 17 - 23, wherein the graphical representation of the edge of the tissue uses a detection algorithm interpolating a plurality of points on the graphical representation of the edge of the tissue.

25. The method of any one of claims 17 - 23, wherein the confidence indicator is a color-coded confidence value representing one or more sections of the edge of the tissue.

26. The method of any one of claims 17 - 23, wherein the graphical representation of the edge of the tissue is generated via real time multi-channel processing and image processing for a display of human interpretable images, while also processing for automated, computer-based image interpretation.

27. The method of any one of claims 17 - 23, further comprising: extracting patient-specific vessel geometry of a patient from intravascular ultrasound image data; extracting geometric features from the patient-specific vessel geometry of the patient; and classifying different types of tissue for one or more locations of interest in the vessel based on extracted geometric features using a trained machine-learning based model trained based on intravascular ultrasound images obtained from intravascular ultrasound catheters operating at different frequencies and based on intravascular ultrasound images of multiple different types of vessels.

28. The method of claim 27, wherein the types of tissues and abnormalities are selected from the group consisting of one more of the following: intima, media, adventitia, lumen, blood, thrombus, tumor, plaque, and calcium; and generating an output for display on a graphical user interface that indicates the different types of tissue or abnormalities; generating a confidence measure associated with the classifying, and outputting the confidence measure on a display of the graphical user interface.

29. The method of any one of claims 17 - 23, further comprising:extracting information from intravascular ultrasound image data of a vessel of a patient; storing the information in memory; and classifying different types of tissue for one or more locations of interest in the vessel based on the extracted and stored information using a trained machine-learning based model that is trained based on intravascular ultrasound images obtained from intravascular ultrasound catheters operating at different frequencies and based on intravascular ultrasound images of multiple different types of vessels.

30. The method of any one of claims 17 - 23, further comprising: extracting data from the intravascular ultrasound images; storing the data in memory; performing a vessel feature detection task on the extracted and stored data using a machine learning based model trained to detect at least a first vessel feature in intravascular ultrasound image data, wherein performing the vessel feature detection task comprises generating an automated output associated with the first vessel feature; and utilizing the automated output associated with the first vessel feature, performing a tissue classification task using a machine learning model trained to classify tissue in the intravascular ultrasound images, wherein performing the tissue classification task comprises generating an automated result of the tissue classification task.

31. A method of intravascular ultrasound imaging, the method comprising: receiving one or more intravascular ultrasound (IVUS) image frames, detecting a vessel boundary using one or more boundary detection algorithms, and calculating a confidence value for a portion of the vessel boundary, wherein a confidence indicator is displayed on an overlayed boundary based on the confidence value, wherein the one or more boundary detection algorithms comprises one or more artificial intelligence (AI) and / or machine learning algorithms.

32. The method of claim 31, further comprising receiving modified vessel boundary data from a user and recalculating a modified confidence value based on the modified vessel boundary data.

33. An intravascular ultrasound imaging system comprising: an intravascular ultrasound (IVUS) catheter; a catheter interface module comprising a motor, wherein the catheter interface module is configured for removable mechanical connection to a catheter interface module mounting surface on a patient chassis; a tablet configured to receive at least one input from a user; a workstation configured for electrical connection to the catheter interface module,wherein the workstation is configured for electrical connection to the tablet, wherein the electrical connection between the workstation and the tablet is wireless; a tablet mount comprising one or more microphones, an electrical contact, a first tablet mount interface, and a second tablet mount interface; wherein the one or more microphones is configured to receive a verbal command from a voice of the user, wherein the one or more microphones is configured to be placed in communication with the tablet, wherein the electrical contact is configured to provide power from the tablet mount to the tablet, wherein the first tablet mount interface is configured for connecting to the tablet via a releasably attachable interface, wherein the releasably attachable interface comprises a latch, and wherein the second tablet mount interface is configured for removable mechanical connection to at least one of: a mounting surface on the patient chassis, a mobile cart, an articulating mount, and a universal mount.

34. The intravascular ultrasound imaging system of claim 33, wherein the catheter interface module is configured for placement outside a sterile field, and wherein the catheter interface module mount is configured to be repositioned on the mounting surface on the patient chassis.

35. The intravascular ultrasound imaging system of claim 33, wherein the tablet mount is configured for placement outside a sterile field, and wherein the tablet mount is configured to be repositioned on the mounting surface on the patient chassis.

36. The intravascular ultrasound imaging system of claim 33, wherein the tablet mount is configured for placement within a sterile field, wherein the tablet mount is configured to be repositioned on the mounting surface on the patient chassis.

37. The intravascular ultrasound imaging system of claim 33, wherein the tablet mount is connected to the articulating mount, wherein the articulating mount comprises one or more articulator arms and a joint, and wherein the joint is configured to lock, unlock, and reposition a position of the one or more articulator arms.

38. The intravascular ultrasound imaging system of claim 33, wherein the tablet mount is connected to a universal mount.

39. The intravascular ultrasound imaging system of claim 38, wherein the universal mount is configured to be connected to a universal mounting surface on one or more of: the patient chassis, a workstation chassis, an articulating mount, and a surface in a procedure room.

40. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the one or more microphones comprise one or more unidirectional or omnidirectional microphones.

41. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet is releasably connected to the tablet mount and is further configured to: identify a direction of the verbal command, determine whether the direction of the verbal command is from a known position of a user; and transmit the verbal command to the workstation in response to determining that the direction of the verbal command in the direction of the verbal command is from the known position of the user.

42. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet mount is further configured to: tune to a direction of the verbal command based on a lab configuration setting established during setup; determine whether the direction of the verbal command is from a preconfigured direction or an automatically configured direction; and determine of the verbal command matches a workflow specific grammar and then translate the verbal command to an actional command sent to the workstation.

43. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet mount is further configured to: determine a speaker who generated the verbal command; suppress competing speakers generating speech outside a direction of the speaker; and transmit the verbal command to the workstation in response to determining that the speaker was the user.

44. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet mount is further configured to filter one or more signals detected by the one or more microphones based on one or more of: a frequency, a variance, and an amplitude of the one or more signals detected by the one or more microphones.

45. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet, tablet mount, or workstation is configured to update a user interface based on the verbal command.

46. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet, tablet mount, or workstation is configured to determine one or more of a grammar context and a social cue context of the verbal command.

47. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet mount is configured for a voice input to be sent to at least one of the workstation and the tablet for processing in to a verbal command.

48. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet, tablet mount, or workstation is configured for an input from a user via touch interaction or via voice input from the user at the tablet mount.

49. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet, tablet mount, or workstation is configured to initiate at least one voice interaction with an element of the user interface based on the verbal command or a touch screen input.

50. The intravascular ultrasound imaging system of claim 49, wherein the element of the user interface is disposed in one or more sub-menus of the user interface.

51. The intravascular ultrasound imaging system of claim 49, wherein the element of the user interface comprises at least one of: a live image element, a label element, a screen capture element at a bookmark, a length measurement element, an area measurement element, an automation element, a brightness, image gain control element, an image diameter (zoom) control element, a measurement summary element, a IVUS image loop element, and / or a timeline element.

52. The intravascular ultrasound imaging system of claim 51, wherein at least one of the workstation and the tablet is configured to: select the automation element based on the verbal command or a touch screen input; automatically calculate one or more measurements of a vascular lumen imaged by the IVUS catheter; and provide one or more IVUS images and the one or more measurements to be displayed.

53. The intravascular ultrasound imaging system of claim 52, wherein the one or more measurements comprise one or more of: a maximum diameter of the vascular lumen imaged by the IVUS catheter, a minimum diameter of the vascular lumen, and an average diameter of the vascular lumen, and an area of the vascular lumen 54. The intravascular ultrasound imaging system of claim 52, wherein the one or more measurements comprises one or more compound measurements, the one or more compound measurements comprising measurements calculated based on a plurality of IVUS images.

55. The intravascular ultrasound imaging system of claim 54, wherein the one or more compound measurements comprise a percent stenosis of a vessel, one or more ratios of maximum to minimum diameters, one or more ratios of maximum to average diameters, one or more ratios of minimum to average diameters, and a computation of cross-frame and cross-recording metrics including blockage.

56. The intravascular ultrasound imaging system of claim 52, wherein the one or more IVUS images comprise one or more of: a longitudinal series of IVUS images or a temporal series of IVUS images.

57. The intravascular ultrasound imaging system of any one of claims 52-56, wherein the workstation is configured to provide one or more graphical representations corresponding with the one or more measurements.

58. The intravascular ultrasound imaging system of claim 57, wherein the graphical representation is a bar graph.

59. The intravascular ultrasound imaging system of claim 51, wherein at least one of the workstation and the tablet is further configured to: select the automation element based on the verbal command or a touch screen input; automatically identify one or more irregularities in the vascular lumen imaged by the IVUS catheter; and provide a graphical representation of the one or more irregularities to be displayed as an overlay on the IVUS image.

60. The intravascular ultrasound imaging system of claim 59, wherein the graphical representation is one of two-dimensional or three-dimensional.

61. The intravascular ultrasound imaging system of claim 59, wherein at least one of the workstation and the tablet is further configured to: calculate at least one property of the one or more irregularities; and provide the graphical representation of the one or more irregularities to be displayed, the graphical representation further comprising the at least one property.

62. The intravascular ultrasound imaging system of claim 61, wherein the at least one property comprises one or more of: at least one dimension and an irregularity type.

63. The intravascular ultrasound imaging system of claims 51, wherein at least one of the workstation and the tablet is further configured to: select the automation element based on the verbal command or a touch screen input; automatically identify a border of a vascular lumen imaged by the IVUS catheter; and provide a graphical representation of the vascular lumen border to be displayed as an overlay on the IVUS image.

64. The intravascular ultrasound imaging system of claim 63, wherein at least one of the workstation and the tablet is further configured to: calculate one or more confidence values associated with one or more sections of the vascular lumen border; and provide the data to support graphical representation of the vascular lumen border to be displayed as the overlay on the IVUS image, wherein the graphical representation of the vascular lumen border is divided into the one or more sections of the vascular lumen and the one or more sections are color-codedbased on the one or more confidence values associated with each of the one or more sections, or one or more control points that define a section of the vascular lumen border.

65. The intravascular ultrasound imaging system of claim 63, wherein at least one of the workstation and the tablet is further configured to: receive an input from a user; identify a custom border of the vascular lumen based on the identified border of the vascular lumen imaged by the IVUS catheter and the input from the user; and update the graphical representation, the graphical representation of the vascular lumen border comprising the custom border.

66. The intravascular ultrasound imaging system of any of claims 33 - 39, wherein at least one of the workstation and the tablet is configured to: receive the verbal command; determine whether the verbal command comprises a wake command; and provide a notification to the user in response to the user in response to determining that the verbal command comprises the wake command, wherein the notification indicates to the user that the system is in a wake mode.

67. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein at least one of the workstation and the tablet is further configured to: receive, a second verbal command; and determine one or more of a grammar context and a social cue context of the other verbal command based on the determination that the first verbal command comprised a wake word.

68. The intravascular ultrasound imaging system of any of claims 33 - 39, wherein at least one of the workstation and the tablet is configured to: receive a touch screen input; determine whether the touch screen input comprises a wake command; and provide a notification to the user in response to the user in response to determining that the touch screen input comprises the wake command, wherein the notification indicates to the user that the system is in a wake mode.

69. The intravascular ultrasound imaging system of any of claims 33 - 39, further comprising a camera.

70. The intravascular ultrasound imaging system of any of claims 33 - 39, wherein the workstation is configured to receive one or more IVUS image labels associated with one or more IVUS images from a user via a verbal command or a touch input.

71. The intravascular ultrasound imaging system of claim 70, wherein the workstation is configured to receive a verbal command comprising the one or more IVUS image labels.

72. The intravascular ultrasound imaging system of claim 70, wherein the one or more IVUS image labels comprise one or more labels associated with a procedure type.

73. The intravascular ultrasound imaging system of claim 70, wherein the workstation is further configured to store one or more sets of procedure-specific labels.

74. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the patient chassis comprises a bed, and wherein the mounting surface comprises a bed rail.

75. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the workstation is removably attachable to the mobile cart, wherein the mobile cart comprises a plurality of wheels, one or more component holders, a handle, and a storage compartment.

76. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the IVUS catheter comprises an imaging core comprises a rotating single element ultrasound transducer, a flexible elongate member, and an imaging lumen of that is filled with an acoustic coupling medium and sealed.

77. The intravascular ultrasound imaging system of claim 76, wherein the rotating single element transducer is configured to acquire a plurality of image lines by a pulse-echo emission and a pulse-echo reception while the rotating single element ultrasound transducer is spinning about a length axis of a driveshaft.

78. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the rotating single element transducer is configured to collect a plurality of image lines with a sampled signal data that includes both amplitude and phase.

79. The intravascular ultrasound imaging system of claim 78, wherein one or more processors are configured to store the plurality of images lines in a computer-readable memory in a custom format configured to maintain a high-fidelity format.

80. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the IVUS catheter further comprises a rigid connector hub, and wherein the catheter interface module comprises an interface configured to receive the rigid connector hub.

81. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein an elongate flexible member comprises a length between eight feet and nine feet.

82. The intravascular ultrasound imaging system of claim 81, wherein the elongate flexible member comprises a working portion, the working portion comprising a length between 100 centimeters and 200 centimeters.

83. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein an elongate member comprises a guidewire with an outer diameter between 0.01 inches and 0.04 inches.

84. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the motor rotates an imaging core at a rate in a range of 1500 - 4000 rpm. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet is configured to be placed in wireless communication with the workstation.

85. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet is configured to execute a user interface.

86. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet is configured to receive the verbal command from the user.

87. The intravascular ultrasound imaging system of claim 86, wherein the tablet is configured to: determine a grammar context and a social cue context associated with the verbal command represent a valid interaction; and transmit at least one command to the workstation.

88. The intravascular ultrasound imaging system of claim 86, wherein the tablet is further configured to determine if the verbal command is one of: a default verbal command or a known custom verbal command.

89. The intravascular ultrasound imaging system of claim 87, wherein the tablet is configured to determine a social cue context based on whether a period of silence occurred prior to receiving the voice command.

90. The intravascular ultrasound imaging system of claim 86, wherein the tablet is configured to transmit the verbal command to the workstation, and wherein one or more processors are configured to: determine a grammar context associated with the verbal command; and generate the IVUS image based on the verbal command.

91. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet comprises at least one of the group consisting of: a touchscreen, a microphone, a camera.

92. The intravascular ultrasound imaging system of any one of claims 33 - 39, further configured to: capture a face of the user via a camera; and authenticate the user based on one or more facial features.

93. The intravascular ultrasound imaging system of claim 91, wherein the tablet is configured to receive a voice input from a user and transmit the voice input to the workstation.

94. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the tablet is configured to be connected to a power source during an IVUS procedure.

95. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the workstation further comprises an ultrasound system control board.

96. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the workstation further comprises a workstation display.

97. The intravascular ultrasound imaging system of claim 96, wherein the workstation display comprises a touch screen display.

98. The intravascular ultrasound imaging system of claim 95, wherein the ultrasound system control board is configured to provide high speed processing, high dynamic range signal capacity, and high-end signalprocessing support precise control of transmit waveforms and receive processing to maximum spatial resolution, temporal resolution, and image contrast for superior image interpretation.

99. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the proximal connector hub further comprises a non-transitory computer-readable memory is configured to store information associated with the IVUS catheter.

100. The intravascular ultrasound imaging system of claim 99, wherein the information associated with the IVUS catheter comprises catheter identification information, usage data, and calibration data.

101. The intravascular ultrasound imaging system of claim 98, wherein the catheter interface module is further configured to: read the non-transitory memory of the rigid connector hub; and transmit the custom system configuration to the workstation, wherein the workstation is further configured to initialize the custom system configuration.

102. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein one or more instructions are configured to cause one or more processors to perform edge-based machine learning computations associated with one or more of a plurality of image lines or the IVUS image.

103. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the workstation is configured for image analysis using an artificial intelligence algorithm to identify a vessel border.

104. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the workstation is configured for image analysis using an artificial intelligence algorithm to identify blood or a location or a type of plaque, calcium, stent apposition, thrombus, or dissection in a peripheral vascular system.

105. The intravascular ultrasound imaging system of claim 104, wherein the artificial intelligence algorithm is pre-trained based on a plurality of IVUS images captured by one or more other IVUS catheters in arterial and venous vessels.

106. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein instructions further cause one or more processors to detect a vessel border.

107. The intravascular ultrasound imaging system of claim 106, wherein the one or more processors are further configured to receive a user input and detect the vessel border based on the user input.

108. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the IVUS catheter is configured for peripheral vascular imaging.

109. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the IVUS catheter is configured for coronary vascular imaging.

110. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein instructions further cause one or more processors to perform a multi-channel processing of a plurality of images.

111. The intravascular ultrasound imaging system of claim 110, wherein the multi-channel processing provides real time processing and image processing for the display of human interpretable images, while also processing for automated, computer based, image interpretation.

112. The intravascular ultrasound imaging system of any one of claims 33 - 39, further comprising at least one cloud server configured to receive and store IVUS procedure data.

113. The intravascular ultrasound imaging system of claim 112, wherein the IVUS procedure data comprises one or more of: a plurality of image lines, the IVUS image, catheter identification information, catheter usage information, and catheter calibration information.

114. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the workstation is further configured to determine a degradation level of a bioresorbable stent.

115. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the workstation is further configured to: automatically create an IVUS procedure report; and provide the IVUS procedure report to be displayed on one or more of: the tablet and a display of the workstation.

116. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the workstation is further configured to provide one or more IVUS images to be displayed on one or more of the tablet and a display of the workstation.

117. The intravascular ultrasound imaging system of claim 116, wherein the one or more IVUS images further comprise one or more of: at least one measurement, at least one label, and at least one bookmark.

118. The intravascular ultrasound imaging system of any one of claims 116-117, wherein the workstation is further configured to provide the one or more IVUS images in a grid.

119. The intravascular ultrasound imaging system of claim 118, wherein the grid is one of: a 1 image by 1 image grid, a 2 image by 2 image grid, a 4 image by 4 image grid, and a 4 image by 2 image grid.

120. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the workstation is further configured to: determine blood flow adjacent to the IVUS catheter based on speckle information in two or more sequential IVUS images.’ 121. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the workstation is configured to automatically configure a local network.

122. The intravascular ultrasound imaging system of claim 121, wherein the workstation is further configured to: search for one or more of the tablet and the tablet mount using an interrogation protocol, wherein tablet and the tablet mount are configured to execute a network configuration client; andconnect one or more of the tablet and the tablet mount to the local network.

123. The intravascular ultrasound imaging system of any of claims 33 - 39, wherein one or more of the workstation and the tablet are configured to execute a user interface.

124. The intravascular ultrasound imaging system of claim 123, wherein the user interface is synchronized across a plurality of displays, the plurality of displays comprising the tablet and a workstation display.

125. The intravascular ultrasound imaging system of any of claims 33 - 39, wherein the workstation is further configured to: instruct the IVUS catheter to capture a plurality of IVUS images during a pullback maneuver; automatically detect one or more vessel dissections in the plurality of IVUS images; and automatically provide a graphical representation of the one or more vessel dissections, the graphical representation comprising one or more highlighted regions corresponding with the one or more vessel dissections.

126. The intravascular ultrasound imaging system of claim 125, wherein the graphical representation of the one or more vessel dissections comprises one or more of: a two-dimensional timeline or a three-dimensional rendering of the vessel captured during the pullback maneuver.

127. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the workstation is configured to provide a plurality of IVUS images captured during an IVUS procedure in a timeline, overlay an imaging metric, wherein the imaging metric is selected from the group consisting of: a diameter, a diameter ratio of diameter / maximum diameter, or aspect ratio of minimum diameter / maximum diameter.

128. The intravascular ultrasound imaging system of claim 127, wherein the timeline includes one or more of: at least one label, at least one bookmark, and at least one measurement.

129. The intravascular ultrasound imaging system of any one of claims 33 - 39, wherein the workstation is further configured to: automatically detect an anatomical landmark in one or more IVUS images; and automatically label the one or more IVUS images as being associated with the anatomical landmark.

130. An intravascular ultrasound imaging system comprising: an intravascular ultrasound (IVUS) catheter comprising: a flexible elongate member comprising an imaging lumen; and an imaging core disposed at a distal end of a driveshaft within the imaging lumen of the flexible elongate member; a catheter interface module comprising a motor, the motor configured to be mechanically connected to the driveshaft to rotate the imaging core;a tablet configured to receive at least one input from a user; a tablet mount configured for removable mechanical connection to the tablet and to one or more mounting surfaces on a patient chassis, wherein the tablet mount is configured to connect a tablet power source to the tablet, wherein the tablet mount comprises one or more microphones, wherein the one or more microphones is configured to receive a verbal command from a voice of the user, wherein the one or more microphones is configured to be placed in communication with the tablet; a workstation configured to be placed in communication with the tablet, the catheter interface module, and the IVUS catheter, the workstation comprising: a non-transitory computer-readable medium storing instructions thereon, wherein the instructions are provided from the verbal command from the voice of the user from the one or more microphones on the tablet mount via the tablet; and a processor configured to execute the instructions, causing the processors to: instruct the motor to rotate the imaging core; instruct the imaging core to capture a plurality of image lines; process the plurality of image lines to generate an IVUS image; and provide the IVUS image to be displayed on the tablet in real time.

131. The intravascular ultrasound imaging system of claim 130, wherein the tablet mount is connected to an articulating mount, wherein the articulating mount comprises one or more articulator arms and a joint, wherein the joint is configured to lock, unlock, and reposition a position of the one or more articulator arms.

132. The intravascular ultrasound imaging system of claim 130, wherein the patient chassis comprises a bed.

133. The intravascular ultrasound imaging system claim 130, wherein the tablet mount is configured to be repositioned on the one or more mounting surfaces on the patient chassis.

134. The intravascular ultrasound imaging system of claim 130, wherein the workstation is removably attachable to a mobile cart, wherein the mobile cart comprises a plurality of wheels, a power connector, one or more component holders, a handle, and a storage compartment, wherein the mobile cart further comprises a tablet with a screen in a range of 12 – 36 inches.

135. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the lumen of the flexible elongate member is filled with an acoustic coupling medium and sealed.

136. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the imaging core comprises a rotating single element ultrasound transducer, wherein the rotating single element transducer is configured to acquire the plurality of image lines by a pulse-echo emission and a pulse-echo reception while the rotating single element ultrasound transducer is spinning about a length axis of the driveshaft.

137. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the IVUS catheter further comprises a rigid connector hub, and wherein the catheter interface module comprises an interface configured to receive the rigid connector hub.

138. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the elongate flexible member comprises a length between eight feet and nine feet.

139. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the elongate member further comprises a 5F sheath or 8F sheath.

140. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the elongate member further comprises a guidewire with an outer diameter between 0.01 inches and 0.04 inches.

141. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the motor rotates the imaging core at a rate in a range of 1500 - 4000 rpm.

142. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the tablet is configured to be placed in wireless communication with the workstation.

143. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the tablet is configured to execute a user interface.

144. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the tablet is configured to receive the verbal command from the user.

145. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the tablet comprises: a touchscreen, a microphone, and at least one audio output device.

146. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the tablet is configured to be connected to a power source during an IVUS procedure.

147. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the workstation further comprises an ultrasound system control board.

148. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the non- transitory computer-readable medium is further configured to store information associated with the IVUS catheter.

149. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the instructions further cause the one or more processors to perform edge-based machine learning computations associated with one or more of the plurality of image lines or the IVUS image.

150. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the instructions further cause the one or more processors to detect a vessel border.

151. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the workstation is configured for image analysis using an artificial intelligence algorithm to identify a vessel border in a peripheral vascular system.

152. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the instructions further cause the one or more processors to perform a multi-channel processing of the plurality of image lines.

153. The intravascular ultrasound imaging system of any one of claims 130 - 134, wherein the workstation is configured for image analysis using an artificial intelligence algorithm to identify blood or a location or a type of plaque, calcium, stent apposition, thrombus, or dissection in a peripheral vascular system.

154. An intravascular ultrasound imaging system comprising: an intravascular ultrasound (IVUS) catheter; a tablet configured to receive at least one input from a user; a tablet mount configured for removable mechanical connection to the tablet and to one or more mounting surfaces on a patient chassis, wherein the tablet mount is configured to connect a tablet power source to the tablet, wherein the tablet mount comprises one or more microphones, wherein the one or more microphones is configured to receive a verbal input from a voice of the user.

155. A method for intravascular ultrasound imaging, the method comprising: providing an intravascular ultrasound (IVUS) catheter, the IVUS catheter comprising a flexible elongate member comprising a lumen and an imaging core disposed at a distal end of a driveshaft within the lumen of the flexible elongate member; providing a catheter interface module, the catheter interface module comprising a motor configured to be mechanically connected to the driveshaft to rotate the imaging core; connecting the catheter interface module to one or more mounting surfaces on a patient chassis using a catheter interface module mount, the catheter interface module mount configured to connect a catheter interface module power source to the catheter interface module; providing a tablet, the tablet configured to receive at least one input from a user; providing a tablet mount comprising one or more microphones, the tablet mount configured to connect a tablet power source to the tablet and receive a verbal input from a voice of the user via the one or more microphones; removably and mechanically connecting the tablet to the one or more mounting surfaces on the patient chassis using the tablet mount; providing a workstation configured to be placed in communication with the one or more microphones, the tablet mount, the tablet, the catheter interface module, and the IVUS catheter, wherein the workstation comprises a non-transitory computer readable memory and one or more processors; rotating, via the motor, the imaging core of the IVUS catheter; capturing, via the imaging core, a plurality of images lines; generating an IVUS image based on the plurality of image lines; andproviding the IVUS image to be display on the tablet in real time.

156. The method of claim 155, wherein the one or more microphones comprise one or more directional microphones.

157. The method of claim 155, further comprising: identifying, via the tablet mount, a direction of the verbal input; determining, via the tablet mount, the direction of the verbal input conditioning the verbal input to optimize sound in the direction of the verbal input transforming the verbal input to a verbal command; and transmitting the verbal command to the workstation in response to determining a valid verbal command 158. The method of claim 155, further comprising: determining, via the tablet mount, a speaker position who generated the verbal input; and transmitting the verbal command to the workstation in response to determining that the verbal input was a valid command.

159. The method of claim 155, further comprising filtering, via the tablet mount, one or more signals detected by the one or more microphones based on one or more of: a frequency, a variance, and an amplitude of the one or more signals detected by the one or more microphones.

160. The method of claim 155, further comprising updating, via the workstation, a user interface based on the verbal command.

161. The method of claim 155, further comprising determining, via the workstation, a grammar context and a social cue context of the verbal command.

162. The method of claim 155, further comprising initiating, via the workstation, at least one voice interaction with an element of the user interface based on the verbal command.

163. The method of claim 162, wherein the element of the user interface comprises at least one of: a live image element, a label element, a screen capture element, a length measurement element, an area measurement element, an automation element, a brightness or gain control element, a zoom control element, a measurement summary element, a IVUS image loop element, and a timeline element.

164. The method of claim 163, further comprising selecting, via the workstation, the automation element based on the verbal command; automatically calculating, via the workstation, one or more measurements of a lumen imaged by the IVUS catheter, the one or more measurements comprising: a maximum diameter of a lumen imaged by the IVUS catheter, a minimum diameter of the lumen, and an average diameter of the lumen, the area of the lumen; and providing an IVUS image and the one or more measurements to be displayed.

165. The method of any one of claims 162 - 163, further comprising selecting, via the workstation, an automation element based on the verbal command; automatically identifying, via the workstation, one or more irregularities in the lumen imaged by the IVUS catheter; and providing a graphical representation of the one or more irregularities to be displayed as an overlay on the IVUS image.

166. The method of claim 165, further comprising calculating, via the workstation, at least one property of the one or more irregularities; and providing the graphical representation of the one or more irregularities to be displayed, the graphical representation further comprising the at least one property.

167. The method of claim 166, wherein the at least one property comprises one or more of: at least one dimension and an irregularity type.

168. The method of any one of claims 162 - 163, further comprising: selecting, via the workstation, the automation element based on the verbal command; automatically identifying, via the workstation, a border of the lumen imaged by the IVUS catheter; and providing a graphical representation of the lumen border to be displayed as an overlay on the IVUS image.

169. The method of claim 168, further comprising: calculating, via the workstation, one or more confidence values associated with one or more sections of the lumen border; and providing the graphical representation of the lumen border to be displayed as the overlay on the IVUS image, wherein the graphical representation of the lumen border is divided into the one or more sections of the lumen and the one or more sections are color-coded based on the one or more confidence values associated with each of the one or more sections.

170. The method of claim 168, further comprising: receiving an input from a user, identifying a custom border of the lumen based on the identified border of the vascular lumen imaged by the IVUS catheter and the input from the user; and updating the graphical representation, the graphical representation of the lumen border comprising the custom border.

171. The method of claim 155, further comprising receiving, via the tablet mount, the verbal command;determining, via the workstation, whether the verbal command comprises a wake command; and providing a notification to the user in response to the user in response to determining that the verbal command comprises the wake command, wherein the notification indicates to the user that the system is in a wake mode.

172. The method of claim 171, further comprising: receiving, via the tablet mount, a second verbal command; and determining, via the workstation, one or more of a grammar context and a social cue context of the other verbal command based on the determination that the first verbal command comprised a wake word.

173. The method of claim 155, wherein the tablet mount further comprises a camera.

174. The method of claim 155, further comprising placing the catheter interface module outside of a sterile field.

175. The method of claim 155, wherein the catheter interface module mount further comprises one or more articulator arms and a joint, wherein the joint is configured to lock, unlock, and reposition a position of the articulator arm.

176. The method of claim 155, further comprising providing a workstation mount configured to provide a removable connection to the workstation, the workstation mount comprising one or more articulator arms and a joint, wherein the joint is configured to lock, unlock, and reposition a position of the articulator arm.

177. The method of claim 176, further comprising repositioning the workstation mount on the one or more mounting surfaces on the patient chassis.

178. The method of claim 155, wherein the tablet mount comprises one or more articulator arms and a joint, wherein the joint is configured to lock, unlock, and reposition a position of the articulator arm.

179. The method of claim 155, wherein the patient chassis comprises a bed.

180. The method of claim 155, wherein repositioning the catheter interface module mount on the one or more mounting surfaces on the patient chassis.

181. The method of claim 155, further comprising repositioning the tablet mount on the one or more mounting surfaces on the patient chassis.

182. The method of claim 155, further comprising: providing a mobile cart comprising a plurality of wheels, a power connector, one or more component holders, a handle, and a storage compartment; and removably connecting the workstation to the mobile cart.

183. The method of claim 182, wherein the mobile cart further comprises a display monitor with a touch screen in a range of 12 – 36 inches.

184. The method of claim 155, further comprising: filling the lumen of the elongate member with an acoustic coupling medium and sealing the lumen.

185. The method of claim 155, wherein the imaging core comprises a rotating single element ultrasound transducer.

186. The method of claim 185, further comprising acquiring, via the rotating single element transducer, the plurality of image lines by a pulse echo emission and a pulse-echo reception while the rotating single element transducer is spinning about a length axis of the driveshaft.

187. The method of claim 185, further comprising collecting, via the rotating single element transducer, the plurality of image lines in a high-fidelity format without loss.

188. The method of claim 187, further comprising storing the plurality of images lines in the non-transitory computer readable memory of the workstation in a custom format configured to maintain the high-fidelity format.

189. The method of claim 155, wherein the IVUS catheter further comprises a rigid connector hub, and wherein the catheter interface module comprises an interface configured to receive the rigid connector hub.

190. The method of claim 155, wherein the elongate flexible member comprises a length between eight feet and nine feet.

191. The method of claim 155, wherein the elongate flexible member comprises a working portion, the working portion comprising a length between 100 centimeters and 200 centimeters.

192. The method of claim 155, wherein the elongate member further comprises a 5F sheath or 8F sheath.

193. The method of claim 155, wherein the elongate member further comprises a guidewire with an outer diameter between 0.01 inches and 0.04 inches.

194. The method of claim 155, further comprising rotating the imaging core, via the motor, at a rate in a range of 1500 - 4000 rpm.

195. The method of claim 155, further comprising placing the tablet in wireless communication with the workstation.

196. The method of claim 155, further comprising, providing a user interface executed by the tablet.

197. The method of claim 155, wherein the tablet is further configured to receive a verbal command from the user.

198. The method of claim 155, further comprising determining a grammar context and a social queue context associated with the verbal command.

199. The method of claim 155, further comprising generating the IVUS image based on the verbal command.

200. The method of claim 155, wherein the tablet comprises at least one the group consisting of: a touchscreen, a microphone, a speaker, and a camera.

201. The method of claim 200, further comprising receiving a voice input from a user via the tablet and transmitting the voice input to the workstation.

202. The method of claim 155, further comprising connecting the tablet to a power source during an IVUS procedure.

203. The method of claim 155, wherein the workstation further comprises an ultrasound system control board.

204. The method of claim 203, wherein the ultrasound system control board is configured to provide high speed processing, high dynamic range signal capacity, and high-end signal processing support precise control of transmit waveforms and receive processing to maximum spatial resolution, temporal resolution, and image contrast for superior image interpretation.

205. The method of claim 155, further comprising storing information associated with the IVUS catheter in the non-transitory computer-readable memory.

206. The method of claim 205, wherein the information associated with the IVUS catheter comprises catheter identification information, usage data, and calibration data.

207. The method of claim 155, further comprising performing, via the one or more processors, edge- based machine learning computations associated with one or more of the plurality of image lines or the IVUS image.

208. The method of claim 155, further comprising detecting, via the one or more processors, a vessel border.

209. The method of claim 208, further comprising receiving a user input and detecting, via the one or more processors, the vessel border based on the user input.

210. The method of claim 155, further comprising performing, via the one or more processors, a multi- channel processing of the plurality of image lines.

211. The method of claim 210, wherein the multi-channel processing provides real time processing and image processing for the display of human interpretable images, while also processing for automated, computer based, image interpretation.

212. The method of claim 155, further comprising providing at least one cloud server configured to receive and store IVUS procedure data.

213. The method of claim 212, the IVUS procedure data comprises one or more of: the plurality of image lines, the IVUS image, catheter identification information, catheter usage information, and catheter calibration information.

214. A method for classifying tissue type or abnormality for one or more locations of interest in a vessel of a patient, the method comprising: receiving intravascular ultrasound image data of the vessel of the patient; extracting patient-specific vessel geometry of the patient from the intravascular ultrasound image data; extracting geometric features from the patient-specific vessel geometry of the patient; and classifying different types of tissues or abnormalities for one or more locations of interest in the vessel based on the extracted geometric features using a trained machine-learning based model trained based on intravascular ultrasound images obtained from intravascular ultrasound catheters operating at different frequencies and based on intravascular ultrasound images of multiple different types of vessels.

215. The computer-implemented method of claim 214, wherein the types of tissues and abnormalities are selected from the group consisting of one more of the following: intima, media, adventitia, lumen, blood, thrombus, tumor, plaque, and calcium.

216. The computer-implemented method of claim 214, further comprising generating an output for display on a graphical user interface that indicates the different types of tissue.

217. The computer-implemented method of claim 216, wherein the different types of tissue are displayed in different colors.

218. The computer-implemented method of any one of claims 214 to 217, further comprising generating a confidence measure associated with the classifying.

219. The computer-implemented method of claim 218, further comprising outputting the confidence measure on a display of a graphical user interface.

220. The computer-implemented method of claim 219, wherein the confidence measure is a global confidence measure or a local confidence measure.

221. The computer-implemented method of any one of claims 214 to 217, wherein the geometric features include a cross-sectional measurement, a thickness, and / or a length.

222. A computer-implemented method of assessing a vessel of a patient, the method comprising: receiving intravascular ultrasound image data of the vessel of the patient; extracting information from the intravascular ultrasound image data of the vessel of the patient; storing the information in memory; and classifying different types of tissue or abnormalities for one or more locations of interest in the vessel based on the extracted and stored information using a trained machine-learning based model that is trained based on intravascular ultrasound images obtained from intravascular ultrasound catheters operating at different frequencies and based on intravascular ultrasound images of multiple different types of vessels.

223. The computer-implemented method of claim 222, wherein the types of tissue and abnormalities are selected from the group consisting of: intima, media, adventitia, lumen, blood, thrombus, tumor, plaque, and calcium.

224. The computer-implemented method of claim 222, further comprising generating an output for display on a graphical user interface that indicates the different types of tissue.

225. The computer-implemented method of claim 224, wherein the different types of tissue are displayed in different colors.

226. The computer-implemented method of any one of claims 222 to 225, further comprising generating a confidence measure associated with the classifying.

227. The computer-implemented method of claim 226, further comprising outputting the confidence measure on a display of a graphical user interface.

228. A computer-implemented method of assessing a vessel of a patient, the method comprising: receiving one or more intravascular ultrasound images of the vessel of the patient; extracting data from the one or more intravascular ultrasound images; storing the data in memory; performing a vessel feature detection task on the extracted and stored data using a machine learning based model trained to detect at least a first vessel feature in intravascular ultrasound image data, wherein performing the vessel feature detection task comprises generating an automated output associated with the first vessel feature; utilizing the automated output associated with the first vessel feature, performing a tissue or abnormality classification task using a machine learning model trained to classify tissue in the one or more intravascular ultrasound images, wherein performing the tissue or abnormality classification task comprises generating an automated result of the tissue or abnormality classification task.

229. The computer-implemented method of claim 228, wherein the extracted data includes amplitude and phase data.

230. The computer-implemented method of claim 228 or 229, wherein the first vessel feature is a lumen boundary and the vessel feature detection task is detection of the lumen boundary.

231. The computer-implemented method of claim 230, wherein the automated output associated with the first vessel feature is graphical output of the lumen boundary.

232. The computer-implemented method of claim 231, wherein the tissue or abnormality classification task includes classifying blood, plaque, or calcium.

233. The computer-implemented method of claim 231, wherein the tissue or abnormality classification task includes classifying a dissection.

234. The computer-implemented method of claim 231, wherein the tissue or abnormality classification task includes classifying a thrombus.

235. The computer-implemented method of claim 231, wherein the tissue or abnormality classification task includes identification of a guidewire or medical device in the one or more intravascular ultrasound images.

236. The computer-implemented method of claim 232, wherein classifying the blood, plaque, or calcium includes generating a qualitative or quantitative assessment of the blood, plaque or calcium.

237. The computer-implemented method of claim 228, further comprising outputting the automated result on a display.

238. The computer-implemented method of claim 237, wherein the automated result indicates different types of tissue based on the tissue classification.

239. The computer-implemented method of claim 238, wherein the indication is provided using different colors.

240. A computer-implemented method of training a neural network for tissue type characterization within intravascular ultrasound images using a disparate-source training approach, the method comprising: receiving multiple sets of digital intravascular ultrasound images of different types of vessels and obtained using multiple different intravascular ultrasound catheters operating at different imaging frequencies; applying one or more transformations to each digital intravascular ultrasound image including geometry-based data augmentation and intensity-based data augmentation to create a modified set of digital intravascular ultrasound images; creating a first training set comprising the received multiple sets of digital intravascular ultrasound images and the modified set of digital intravascular ultrasound images, and a first set of unmodified digital intravascular ultrasound images; training the neural network in a first stage using the first training set; creating a second training set for a second stage of training comprising the first training set and a second set of unmodified digital intravascular ultrasound images; and training the neural network in the second stage using the second training set.

241. The computer-implemented method of claim 240, wherein the ultrasound images include both amplitude and phase and are transformed into a modified set of images.

242. The computer-implemented method of claim 240, wherein the different types of vessels include coronary vessels and peripheral vessels.

243. The computer-implemented method of claim 240, wherein the different types of vessels include arteries and veins.

244. The computer-implemented method of claim 240, wherein the multiple different intravascular ultrasound catheters are manufactured by different manufacturers.

245. An ultrasound imaging system comprising: a catheter comprising a catheter lumen and an imaging core; a catheter interface module comprising a motor; and a processor, wherein the imaging core comprises a single element ultrasound transducer, wherein the imaging core is configured to rotate within the catheter lumen; wherein the catheter interface module is configured for mechanical and electrical connection to the catheter, wherein the motor is configured to rotate the imaging core within the catheter lumen; and wherein the processor is configured to: automatically calculate one or more measurements of a tissue from an image imaged by the imaging core, automatically identify an edge of the tissue; and calculate one or more confidence values associated with one or more sections of the edge of the tissue; and provide a graphical representation of the edge of the tissue to be displayed in real time as an overlay on the image, wherein the graphical representation of the edge of the tissue is divided into the one or more sections of the edge of the tissue based on the one or more confidence values associated with each of the one or more sections of the edge of the tissue, wherein the imaging system is configured for use in a blood vessel, in a bodily lumen other than a blood vessel, and / or in tissue located outside a lumen.

246. A method of enhanced ultrasound imaging for real time border detection, the method comprising: receiving an ultrasound image of a tissue from a rotating imaging core in a catheter lumen, an image of a tissue; automatically identifying an edge of a tissue in the ultrasound image; calculating one or more confidence values associated with one or more sections of the edge of the tissue; and providing a graphical representation of the edge of the tissue to be displayed as an overlay on the ultrasound image in real time, wherein the graphical representation is divided into the one or more sections of the edge of the tissue with a confidence indicator based on the one or more confidence values associated with each of the one or more sections of the edge of the tissue,wherein the ultrasound image is in a blood vessel, in a bodily lumen other than a blood vessel, and / or in tissue located outside a lumen.

247. A method of enhanced ultrasound imaging for real time boundary detection, the method comprising: retrieving one or more ultrasound image frames, detecting a tissue boundary using one or more boundary detection algorithms, calculating a confidence value for a portion of the vessel boundary, wherein a confidence indicator is displayed on the overlayed boundary based on the confidence value, wherein the one or more ultrasound image frames is in a blood vessel, in a bodily lumen other than a blood vessel, and / or in tissue located outside a lumen.

248. An ultrasound imaging system comprising: an ultrasound catheter; a catheter interface module comprising a motor, wherein the catheter interface module is configured for removable mechanical connection to a catheter interface module mounting surface on a patient chassis; a tablet configured to receive at least one input from a user; a workstation configured for electrical connection to the catheter interface module, wherein the workstation is configured for electrical connection to the tablet, wherein the electrical connection between the workstation and the tablet is wireless; a tablet mount comprising one or more microphones, an electrical contact, a first tablet mount interface, and a second tablet mount interface; wherein the one or more microphones is configured to receive a verbal command from a voice of the user, wherein the one or more microphones is configured to be placed in communication with the tablet, wherein the electrical contact is configured to provide power from the tablet mount to the tablet, wherein the first tablet mount interface is configured for connecting to the tablet via a releasably attachable interface, wherein the releasably attachable interface comprises a latch, wherein the second tablet mount interface is configured for removable mechanical connection to at least one of: a mounting surface on the patient chassis, a mobile cart, an articulating mount, and a universal mount, wherein the imaging system is configured for use in a blood vessel, in a bodily lumen other than a blood vessel, and / or in tissue located outside a lumen.

249. An ultrasound imaging system comprising: an ultrasound catheter comprising:a flexible elongate member comprising an imaging lumen; and an imaging core disposed at a distal end of a driveshaft within the imaging lumen of the flexible elongate member; a catheter interface module comprising a motor, the motor configured to be mechanically connected to the driveshaft to rotate the imaging core; a tablet configured to receive at least one input from a user; a tablet mount configured for removable mechanical connection to the tablet and to one or more mounting surfaces on a patient chassis, wherein the tablet mount is configured to connect a tablet power source to the tablet, wherein the tablet mount comprises one or more microphones, wherein the one or more microphones is configured to receive a verbal command from a voice of the user, wherein the one or more microphones is configured to be placed in communication with the tablet; a workstation configured to be placed in communication with the tablet, the catheter interface module, and the catheter, the workstation comprising: a non-transitory computer-readable medium storing instructions thereon, wherein the instructions are provided from the verbal command from the voice of the user from the one or more microphones on the tablet mount via the tablet; and a processor configured to execute the instructions, causing the processors to: instruct the motor to rotate the imaging core; instruct the imaging core to capture a plurality of image lines; process the plurality of image lines to generate an image; and provide the image to be displayed on the tablet in real time; wherein the imaging system is configured for use in a blood vessel, in a bodily lumen other than a blood vessel, and / or in tissue located outside a lumen.

250. An ultrasound imaging system comprising: an ultrasound catheter; a tablet configured to receive at least one input from a user; a tablet mount configured for removable mechanical connection to the tablet and to one or more mounting surfaces on a patient chassis, wherein the tablet mount is configured to connect a tablet power source to the tablet, wherein the tablet mount comprises one or more microphones, wherein the one or more microphones is configured to receive a verbal input from a voice of the user; wherein the imaging system is configured for use in a blood vessel, in a bodily lumen other than a blood vessel, and / or in tissue located outside a lumen.

251. A computer-implemented method of assessing a tissue of a patient, the method comprising: receiving ultrasound image data of the tissue of the patient;extracting information from the ultrasound image data of the tissue of the patient; storing the information in memory; and classifying different types of tissue for one or more locations of interest in the tissue based on the extracted and stored information using a trained machine-learning based model that is trained based on ultrasound images obtained from ultrasound catheters operating at different frequencies and based on ultrasound images of multiple different types of tissues wherein the ultrasound image data is from a blood vessel, a bodily lumen other than a blood vessel, and / or a tissue located outside a lumen.

252. A computer-implemented method of assessing a tissue of a patient, the method comprising: receiving one or more ultrasound images of the tissue of the patient; extracting data from the one or more ultrasound images; storing the data in memory; performing a vessel feature detection task on the extracted and stored data using a machine learning based model trained to detect at least a first tissue feature in ultrasound image data, wherein performing the tissue feature detection task comprises generating an automated output associated with the first tissue feature; utilizing the automated output associated with the first tissue feature, performing a tissue classification task using a machine learning model trained to classify tissue in the one or more ultrasound images, wherein performing the tissue classification task comprises generating an automated result of the tissue classification task, wherein the ultrasound images are from a blood vessel, a bodily lumen other than a blood vessel, and / or a tissue located outside a lumen.

253. A computer-implemented method of training a neural network for tissue type characterization within ultrasound images using a disparate-source training approach, the method comprising: receiving multiple sets of digital ultrasound images of different types of tissue and obtained using multiple different ultrasound catheters operating at different imaging frequencies; applying one or more transformations to each digital ultrasound image including geometry- based data augmentation and intensity-based data augmentation to create a modified set of digital ultrasound images; creating a first training set comprising the received multiple sets of digital ultrasound images and the modified set of digital ultrasound images, and a first set of unmodified digital ultrasound images; training the neural network in a first stage using the first training set; creating a second training set for a second stage of training comprising the first training set and a second set of unmodified digital ultrasound images; andtraining the neural network in the second stage using the second training set, wherein the digital ultrasound images are from a blood vessel, a bodily lumen other than a blood vessel, and / or a tissue located outside a lumen.

254. A catheter interface module comprising: a motor; a claim, and a lever, wherein the lever is configured to operate the clamp between an open position and a locked position, wherein the lever is configured to serve as a handle for transporting catheter interface module in the open position.

255. A kit, comprising one or more of the catheters, modules, or mounts as described herein along with instructions for use.

256. A device, system, or method according to any one of the preceding claims further comprising displaying one or more images on a screen, head-mounted display, monitor or other visualization platform.

257. A use of any of the devices, systems and methods according to any one of the preceding claims for imaging without any therapy.

258. A use of any of the devices, systems and methods according to any one of the preceding claims for imaging before, after or simultaneously with using ultrasound as a therapy on the same or different system.

259. A use of any of the devices, systems and methods according to any one of the preceding claims for imaging before, after or simultaneously with using non-ultrasound technology as a therapy.

260. A use of any of the devices, systems and methods according to any one of the preceding claims for minimally invasive imaging.

261. A use of any of the devices, systems and methods according to any one of the preceding claims for imaging of intravascular or intraluminal tissue for identifying irregularities and abnormalities.

262. The use of any of the devices, systems and methods according to Claim 261, wherein the irregularities and abnormalities include vascular malformations, constrictions, occlusions, dilations, disease, fibroids, polyps and other tumors, or injury.

263. A use of any of the devices, systems and methods according to any one of the preceding claims for imaging and optionally visualizing and detecting the boundaries of an abnormality, such as an abnormal tissue growth, wherein such growth is a benign or cancerous cyst or tumor, and wherein the tumor includes, for example, fibroids and polyps including but not limited to those located in reproductive organs such as the uterus, the nasal or ear cavity, rectum, colon, other intestinal regions or elsewhere.

264. A use of any of the devices, systems and methods according to any one of the preceding claims for identification of lesions, plaque measurement, thrombus, and preparation of sites for deploying stents or balloons.

265. A use of any of the devices, systems and methods according to any one of the preceding claims, with artificial intelligence (AI) to determine patient eligibility for further intervention and additionally use of the system and AI to reduce risk that patient receives unnecessary further interventions.

266. A method of 2D and / or 3D imaging of collateral vessels and / or side branches having one or more of the features described in the foregoing description.

267. A method of imaging with ultrasound having one or more of the features described in the foregoing description.

268. A method of manufacture of any of the devices and systems having one or more of the features described in the foregoing description.

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