Patent Description:
Various types of intraluminal (also referred to as intravascular) imaging systems are used in diagnosing and treating diseases. For example, intravascular ultrasound (IVUS) imaging is widely used in interventional cardiology as a diagnostic tool for visualizing vessels within a body of a patient. This may aid in assessing vessels, such as a arteries, veins, and other lumens within the human body to determine the need for treatment, to optimize treatment, and/or to assess its effectiveness.

In some cases, intraluminal imaging is carried out with an IVUS device including one or more ultrasound transducers. The IVUS device may be passed into the vessel or artery and guided to an area of interest to be imaged. The transducers emit ultrasonic energy and receive ultrasound echoes reflected from the vessel. The ultrasound echoes are processed to create one or more images of the area of interest. The images of the areas of interest may include one or more lesions or blockages in the vessel. One or more stents may be placed within the vessel or artery to treat these lesions and intraluminal imaging may be carried out to view the placement of the stent within the vessel.

In imaging analysis of the intraluminal images, it may be useful to judge the severity of a lesion within the vessel or artery by generating and displaying measurements that correspond to landmarks. These landmarks may assist in treatment planning. To identify these landmarks in existing intraluminal imaging systems, a medical professional manually selects and marks imaging data to identify landmarks. In particular, the medical professional may select a single frame of imaging data, inspect the frame, manually select a number of points on the image (such as around a tissue border in the image) with an input device, and calculate the dimensions of the area within the points to determine a vessel or lumen area. The medical professional may then proceed to another frame and repeat the same process. Through analysis of these manually marked areas, the medical professional may be able to estimate the extent and severity of a lesion within the lumen.

However, because many frames may be analyzed, requiring a high level of expertise, this process can be time consuming and costly. Furthermore, existing intraluminal imaging systems may lead to logistical and judgment errors because of confusion between the many frames that are analyzed and the difficulty in scrolling through the frames to identify a lesion. This may cause the medical professional to completely miss a lesion or misjudge the extent of the lesion. Thus, deficiencies exist in current intraluminal image systems for identifying landmarks and assessing lesions.

<CIT> addresses a possibility for a physician to see where a catheter is crossing an occlusion within a vessel. It is described that intravascular images and angiographic images are co-registered and presented on a display. As an imaging catheter is pushed through the occlusion, a center point of the catheter and an outline of the vessel wall can be displayed.

<CIT> describes devices, systems, and methods for evaluating patient vasculature. In some instances, external imaging data, physiology data as well as intravascular imaging data associated with a vessel are obtained; the physiology data and the intravascular imaging data are co-registered with the external imaging data; a three-dimensional graphical representation of the vessel is generated based on the external imaging data, the physiology data and the intravascular imaging data; and the graphical representation of the vessel is displayed.

<CIT> relates to computer-based visualization of a stent position within a blood vessel.

<CIT> discloses an image processing apparatus and an image display system, the display being configured to show angiographic images as well as a reconstructed three-dimensional image of a vessel structure based on tomography data.

<CIT> forms prior art under Article <NUM>(<NUM>) EPC and discloses diagnostic tools, methods and systems to plan stent deployment relative to a blood vessel representation using collected data, wherein a display shows a reconstructed view of a blood vessel next to a display of a tomographic image of a section of that blood vessel.

Systems, devices, and methods for identifying landmarks in a lumen and assessing a blockage within a body lumen (e.g., a lesion within a blood vessel) are provided. In particular, the intraluminal imaging system may provide automated identification and measurement of landmarks, areas of interest, and lesions within the lumen. These measurements may be displayed with intraluminal images and may be used to recommend further imaging or treatment procedures. Aspects of the present disclosure advantageously provide intraluminal landmark identification and measurement that overcome the limitations of existing intraluminal imaging systems.

Embodiments of the present disclosure provide an intraluminal medical imaging system, which may include: a controller in communication with an intraluminal imaging device configured to be positioned within a body lumen of a patient, the controller configured to: receive imaging data from the intraluminal imaging device as it is moved through the body lumen of the patient; generate a set of image frames using the received imaging data; automatically calculate a luminal area associated with the body lumen for each of the image frames; and a display device in communication with the controller and configured to display, on a single screen, a first image frame of the set of image frames, the calculated luminal area corresponding to the first image frame, and a longitudinal view of the body lumen.

In some embodiments, the first image frame is a two-dimensional tomographic image of the body lumen. In systems according to the claimed invention, the display device is further configured to display a hybrid two-dimensional/three-dimensional image including the first image frame and a depiction of a portion of the body lumen extending from the first image frame. A location of the first image frame within the body lumen may be displayed on the longitudinal view of the body lumen. The display device may be further configured to display an area of interest including a lesion.

In some embodiments, the display device is further configured to display, on the single screen, a percentage of narrowing of the body lumen within the area of interest. The controller may be further configured to automatically determine an optimal location for a stent based on the received image data. The display device may be further configured to display the optimal location on the longitudinal view of the body lumen.

A method of intraluminal medical imaging is also provided, which may include: receiving, with a controller in communication with a intraluminal imaging device positioned within a body lumen of a patient, imaging data associated with the body lumen; generating, with the controller, a set of image frames using the received imaging data; automatically calculating, with the controller, a luminal area of each of the image frames; and displaying, on a single screen of a display device, a first image frame of the set of image frames, the calculated luminal area corresponding to the first image frame, and a longitudinal view of the body lumen.

In embodiments according to the invention, the first image frame is a two-dimensional tomographic image of the body lumen. The method may include displaying, on the display device, a hybrid two-dimensional/three-dimensional image including the first image frame and a depiction of a portion of the body lumen extending from the first image frame. A location of the first image frame within the body lumen may be displayed on the longitudinal view of the body lumen. The method may include displaying, on the single screen of the display device, an area of interest within the body lumen including a lesion.

In some embodiments, the method may include displaying, on the single screen of the display device, a percentage of narrowing of the body lumen within the area of interest. The method may include determining, with the controller, an optimal location for a stent based on the received image data. The method may include comprising displaying the optimal location on the longitudinal view of the body lumen.

<FIG> is a diagrammatic schematic view of an intraluminal imaging system <NUM>, according to aspects of the present disclosure. The intraluminal imaging system <NUM> can be an intravascular ultrasound (IVUS) imaging system in some embodiments. The intraluminal imaging system <NUM> may include an intraluminal device <NUM>, a patient interface module (PIM) <NUM>, a console or processing system <NUM>, and a monitor <NUM>. The intraluminal device <NUM> is sized and shaped, and/or otherwise structurally arranged to be positioned within a body lumen of a patient. For example, the intraluminal device <NUM> can be a catheter, guide wire, guide catheter, pressure wire, and/or flow wire in various embodiments. In some circumstances, the system <NUM> may include additional elements and/or may be implemented without one or more of the elements illustrated in <FIG>. In some embodiments, the intraluminal imaging system <NUM> is configured to automatically identify and measure landmarks within a lumen, such as tissue borders, areas of interest, and lesions. These measurements may assist a user in visualizing the lumen, as well as recommending further imaging or treatment procedures.

The devices, systems, and methods described herein can include one or more features described in <CIT>, filed on an even date herewith, <CIT>, filed on an even date herewith, <CIT>, filed on an even date herewith, and <CIT>, filed on an even date herewith.

The intraluminal imaging system <NUM> (or intravascular imaging system) can be any type of imaging system suitable for use in the lumens or vasculature of a patient. In some embodiments, the intraluminal imaging system <NUM> is an intraluminal ultrasound (IVUS) imaging system. In other embodiments, the intraluminal imaging system <NUM> may include systems configured for forward looking intraluminal ultrasound (FL-IVUS) imaging, intraluminal photoacoustic (IVPA) imaging, intracardiac echocardiography (ICE), transesophageal echocardiography (TEE), and/or other suitable imaging modalities.

It is understood that the system <NUM> and/or device <NUM> can be configured to obtain any suitable intraluminal imaging data. In some embodiments, the device <NUM> can include an imaging component of any suitable imaging modality, such as optical imaging, optical coherence tomography (OCT), etc. In some embodiments, the device <NUM> can include any suitable imaging component, including a pressure sensor, a flow sensor, a temperature sensor, an optical fiber, a reflector, a mirror, a prism, an ablation element, a radio frequency (RF) electrode, a conductor, and/or combinations thereof. Generally, the device <NUM> can include an imaging element to obtain intraluminal data associated with the lumen <NUM>. The device <NUM> may be sized and shaped (and/or configured) for insertion into a vessel or lumen <NUM> of the patient.

The system <NUM> may be deployed in a catheterization laboratory having a control room. The processing system <NUM> may be located in the control room. Optionally, the processing system <NUM> may be located elsewhere, such as in the catheterization laboratory itself. The catheterization laboratory may include a sterile field while its associated control room may or may not be sterile depending on the procedure to be performed and/or on the health care facility. The catheterization laboratory and control room may be used to perform any number of medical imaging procedures such as angiography, fluoroscopy, CT, IVUS, virtual histology (VH), forward looking IVUS (FL-IVUS), intraluminal photoacoustic (IVPA) imaging, a fractional flow reserve (FFR) determination, a coronary flow reserve (CFR) determination, optical coherence tomography (OCT), computed tomography, intracardiac echocardiography (ICE), forward-looking ICE (FLICE), intraluminal palpography, transesophageal ultrasound, fluoroscopy, and other medical imaging modalities, or combinations thereof. In some embodiments, device <NUM> may be controlled from a remote location such as the control room, such than an operator is not required to be in close proximity to the patient.

The intraluminal device <NUM>, PIM <NUM>, and monitor <NUM> may be communicatively coupled directly or indirectly to the processing system <NUM>. These elements may be communicatively coupled to the medical processing system <NUM> via a wired connection such as a standard copper link or a fiber optic link and/or via wireless connections using IEEE <NUM> Wi-Fi standards, Ultra Wide-Band (UWB) standards, wireless FireWire, wireless USB, or another high-speed wireless networking standard. The processing system <NUM> may be communicatively coupled to one or more data networks, e.g., a TCP/IP-based local area network (LAN). In other embodiments, different protocols may be utilized such as Synchronous Optical Networking (SONET). In some cases, the processing system <NUM> may be communicatively coupled to a wide area network (WAN). The processing system <NUM> may utilize network connectivity to access various resources. For example, the processing system <NUM> may communicate with a Digital Imaging and Communications in Medicine (DICOM) system, a Picture Archiving and Communication System (PACS), and/or a Hospital Information System via a network connection.

At a high level, the intraluminal device <NUM> emits ultrasonic energy from a transducer array <NUM> included in scanner assembly <NUM> mounted near a distal end of the intraluminal device <NUM>. The ultrasonic energy is reflected by tissue structures in the medium (such as a lumen <NUM>) surrounding the scanner assembly <NUM>, and the ultrasound echo signals are received by the transducer array <NUM>. The scanner assembly <NUM> generates electrical signal(s) representative of the ultrasound echoes. The scanner assembly <NUM> can include one or more single ultrasound transducers and/or a transducer array <NUM> in any suitable configuration, such as a planar array, a curved array, a circumferential array, an annular array, etc. For example, the scanner assembly <NUM> can be a one-dimensional array or a two-dimensional array in some instances. In some instances, the scanner assembly <NUM> can be a rotational ultrasound device. The active area of the scanner assembly <NUM> can include one or more transducer materials and/or one or more segments of ultrasound elements (e.g., one or more rows, one or more columns, and/or one or more orientations) that can be uniformly or independently controlled and activated. The active area of the scanner assembly <NUM> can be patterned or structured in various basic or complex geometries. The scanner assembly <NUM> can be disposed in a side-looking orientation (e.g., ultrasonic energy emitted perpendicular and/or orthogonal to the longitudinal axis of the intraluminal device <NUM>) and/or a forward-looking looking orientation (e.g., ultrasonic energy emitted parallel to and/or along the longitudinal axis). In some instances, the scanner assembly <NUM> is structurally arranged to emit and/or receive ultrasonic energy at an oblique angle relative to the longitudinal axis, in a proximal or distal direction. In some embodiments, ultrasonic energy emission can be electronically steered by selective triggering of one or more transducer elements of the scanner assembly <NUM>.

The ultrasound transducer(s) of the scanner assembly <NUM> can be a piezoelectric micromachined ultrasound transducer (PMUT), capacitive micromachined ultrasonic transducer (CMUT), single crystal, lead zirconate titanate (PZT), PZT composite, other suitable transducer type, and/or combinations thereof. In an embodiment the ultrasound transducer array <NUM> can include any suitable number of individual transducers between <NUM> transducer and <NUM> transducers, including values such as <NUM> transducers, <NUM> transducers, <NUM> transducers, <NUM> transducers, <NUM> transducers, <NUM> transducers, <NUM> transducers, and/or other values both larger and smaller.

The PIM <NUM> transfers the received echo signals to the processing system <NUM> where the ultrasound image (including the flow information) is reconstructed and displayed on the monitor <NUM>. The console or processing system <NUM> can include a processor and a memory. The processing system <NUM> may be operable to facilitate the features of the intraluminal imaging system <NUM> described herein. For example, the processor can execute computer readable instructions stored on the non-transitory tangible computer readable medium.

The PIM <NUM> facilitates communication of signals between the processing system <NUM> and the scanner assembly <NUM> included in the intraluminal device <NUM>. This communication may include providing commands to integrated circuit controller chip(s) within the intraluminal device <NUM>, select particular element(s) on the transducer array <NUM> to be used for transmit and receive, providing the transmit trigger signals to the integrated circuit controller chip(s) to activate the transmitter circuitry to generate an electrical pulse to excite the selected transducer array element(s), and/or accepting amplified echo signals received from the selected transducer array element(s) via amplifiers included on the integrated circuit controller chip(s). In some embodiments, the PIM <NUM> performs preliminary processing of the echo data prior to relaying the data to the processing system <NUM>. In examples of such embodiments, the PIM <NUM> performs amplification, filtering, and/or aggregating of the data. In an embodiment, the PIM <NUM> also supplies high- and low-voltage DC power to support operation of the intraluminal device <NUM> including circuitry within the scanner assembly <NUM>.

In some embodiments, the IVUS data and/or the external ultrasound data may be co-registered with the 2D or 3D CT image, which may further improve placement accuracy and decrease procedural time. The placement of the intraluminal device <NUM> may be verified with this multi-imaging system, which may improve outcomes versus standard fluoroscopic guidance. In some embodiments, the intraluminal device <NUM> is tracked to the target location as identified on a CT image and/or angiogram (such as a lesion or aneurysm). In some embodiments, a roadmap produced from co-registered IVUS and CT image data may be correlated to fluoroscopic data to further improve accuracy. For example, the processing system <NUM> may create an imaging loop based on the roadmap and fluoroscopic data to improve the navigation of the intraluminal device <NUM> through the vessels of the patient.

The processing system <NUM> receives echo data from the scanner assembly <NUM> by way of the PIM <NUM> and processes the data to reconstruct an image of the tissue structures in the medium surrounding the scanner assembly <NUM>. Generally, the device <NUM> can be utilized within any suitable anatomy and/or body lumen of the patient. The processing system <NUM> outputs image data such that an image of the vessel or lumen <NUM>, such as a cross-sectional IVUS image of the lumen <NUM>, is displayed on the monitor <NUM>. Lumen <NUM> may represent fluid filled or surrounded structures, both natural and man-made. Lumen <NUM> may be within a body of a patient. Lumen <NUM> may be a blood vessel, as an artery or a vein of a patient's vascular system, including cardiac vasculature, peripheral vasculature, neural vasculature, renal vasculature, and/or or any other suitable lumen inside the body. For example, the device <NUM> may be used to examine any number of anatomical locations and tissue types, including without limitation, organs including the liver, heart, kidneys, gall bladder, pancreas, lungs; ducts; intestines; nervous system structures including the brain, dural sac, spinal cord and peripheral nerves; the urinary tract; as well as valves within the blood, chambers or other parts of the heart, and/or other systems of the body. In addition to natural structures, the device <NUM> may be used to examine man-made structures such as, but without limitation, heart valves, stents, shunts, filters and other devices.

The controller or processing system <NUM> may include a processing circuit having one or more processors in communication with memory and/or other suitable tangible computer readable storage media. The controller or processing system <NUM> may be configured to carry out one or more aspects of the present disclosure. In some embodiments, the processing system <NUM> and the monitor <NUM> are separate components. In other embodiments, the processing system <NUM> and the monitor <NUM> are integrated in a single component. For example, the system <NUM> can include a touch screen device, including a housing having a touch screen display and a processor. The system <NUM> can include any suitable input device, such as a touch sensitive pad or touch screen display, keyboard/mouse, joystick, button, etc., for a user to select options shown on the monitor <NUM>. The processing system <NUM>, the monitor <NUM>, the input device, and/or combinations thereof can be referenced as a controller of the system <NUM>. The controller can be in communication with the device <NUM>, the PIM <NUM>, the processing system <NUM>, the monitor <NUM>, the input device, and/or other components of the system <NUM>.

In some embodiments, the processing system <NUM> may be configured to automatically measure landmarks or key luminal areas within a lumen. These landmarks may include borders of tissue layers (such as a lumen or vessel border). The dimensions of these landmarks may be automatically measured by the processing system <NUM>. These measurements may be displayed on one or more images of the lumen. In some embodiments, the measurements may be used to identify lesions within the lumen and determine the severity and extent of these lesions. The identification and measurement these landmarks may a user to easily visualize a lumen within the patient and accurately assess the severity and extent of lesions therein. This may add confidence to the assessment of lesions and save time in measurement procedures.

In some embodiments, the intraluminal device <NUM> includes some features similar to traditional solid-state IVUS catheters, such as the EagleEye® catheter available from Volcano Corporation and those disclosed in <CIT>. For example, the intraluminal device <NUM> may include the scanner assembly <NUM> near a distal end of the intraluminal device <NUM> and a transmission line bundle <NUM> extending along the longitudinal body of the intraluminal device <NUM>. The cable or transmission line bundle <NUM> can include a plurality of conductors, including one, two, three, four, five, six, seven, or more conductors.

The transmission line bundle <NUM> terminates in a PIM connector <NUM> at a proximal end of the intraluminal device <NUM>. The PIM connector <NUM> electrically couples the transmission line bundle <NUM> to the PIM <NUM> and physically couples the intraluminal device <NUM> to the PIM <NUM>. In an embodiment, the intraluminal device <NUM> further includes a guidewire exit port <NUM>. Accordingly, in some instances the intraluminal device <NUM> is a rapid-exchange catheter. The guidewire exit port <NUM> allows a guidewire <NUM> to be inserted towards the distal end in order to direct the intraluminal device <NUM> through the lumen <NUM>.

The monitor <NUM> may be a display device such as a computer monitor or other type of screen. The monitor <NUM> may be used to display selectable prompts, instructions, and visualizations of imaging data to a user. In some embodiments, the monitor <NUM> may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure. This workflow may include performing a pre-stent plan to determine the state of a lumen and potential for a stent, as well as checking on a stent that has been positioned in a lumen. The workflow may be presented to a user as any of the displays or visualizations shown in <FIG>.

<FIG> shows an exemplary display <NUM> showing a prompt <NUM> according to aspects of the present disclosure. In some embodiments, the display <NUM> is displayed on the monitor <NUM> as shown in <FIG>. In other embodiments, the display <NUM> is displayed on a screen of another device, such as PIM <NUM>. The display <NUM> may be generated by a controller of the intraluminal imaging system <NUM>. In some embodiments, the display <NUM> is configured to display prompts and instructions as well as other data to an operator. The display <NUM> may be used to show a complete end-to-end workflow for an intraluminal procedure. This workflow may include a number of prompts and instructions that may guide an operator through a procedure. This may simplify the steps of a procedure and help to avoid operator errors.

The prompts and instructions may be displayed on the display <NUM> as selectable options such that an operator may interact with the display <NUM> to choose options. The selections of the operator may change the display <NUM> such that information corresponding with the selected options is shown. In the example of <FIG>, a selectable prompt <NUM> is displayed on display <NUM>. The prompt includes two selectable options: option <NUM> corresponds to a pre-stent plan and option <NUM> corresponds to a post-stent check. The operator may select one of the options <NUM>, <NUM> which may move the workflow forward, such that other screens are displayed (such as prompt <NUM> as shown in <FIG>). The options <NUM>, <NUM> may include visual representations of the type of procedure. For example, option <NUM> may include a depiction of vasculature within the heart and option <NUM> may include a depiction of a stent. In some embodiments, a change in the visual depiction of the option <NUM>, <NUM> may show a preference for a certain type of procedure. For example, the option <NUM> may appear as shaded or grey if the system determines that the option <NUM> is not suited to the procedure at hand. In other embodiments, the selection of an option <NUM>, <NUM> may involve a change in the visual depiction of the option <NUM>, <NUM>. For example, if the pre-stent plan option <NUM> is selected, the option <NUM> may appear as shaded or grey in future displays of the display <NUM>. This may help to indicate that this option <NUM> has previously been selected by an operator. Other types of feedback may be used to indicate selections of options. For example, the selectable options <NUM>, <NUM> may display blinking areas, highlighted areas, altered colors, shading, altered transparencies, and other visual indicators.

Option <NUM> may provide a tailored workflow for a pre-stent plan that may include performing an intraluminal procedure (such as a pullback operation) and viewing automated results. Option <NUM> may be used to identify areas within a lumen <NUM> that may benefit from the placement of a stent. Option <NUM> may provide a tailored workflow for a post-stent check that may include performing an intraluminal procedure (such as a pullback operation) and viewing relevant results of an area within a lumen <NUM> where a stent has been placed (such as an edge dissection or a malapposition). This option <NUM> may be used to observe the placement and effectiveness of the stent.

<FIG> shows an exemplary display <NUM> showing a prompt <NUM> according to aspects of the present disclosure. In some embodiments, the prompt <NUM> may be displayed after either of the options <NUM>, <NUM> are selected. In other embodiments, the prompt <NUM> is displayed only after the pre-stent plan option <NUM> is selected. The prompt <NUM> may prompt the operator to select a target vessel. In the example of <FIG>, selecting the target vessel includes selecting a region on a visualization <NUM> including arteries in the heart. The selectable regions may include the right coronary artery (RCA), left anterior descending (LAD), and left circumflex artery (LCX). The selectable regions may also include various regions of the arteries, as well as other vessels and lumens within other parts of the anatomy of a patient. The appearance of the visualization <NUM> may be altered when one of the regions is selected by the operator. For example, the selected artery may be outlined, highlighted, or colored with a different color. In some embodiments, the selected artery is outlined in blue, as shown in <FIG>.

<FIG> shows an exemplary display <NUM> showing a prompt <NUM> according to aspects of the present disclosure. The prompt <NUM> may be displayed after the operator has made a selection on the prompt <NUM> shown in <FIG>. In the example of <FIG>, the LAD artery has been selected by an operator. The prompt <NUM> shows the outlined image of the LAD along with instructions <NUM> to perform a pullback procedure from the most distal point on the LAD to the ostium. These instructions <NUM> may refer to a pullback procedure or other movement of the device <NUM> within the selected vessel or lumen <NUM>. The instructions <NUM> may instruct an operator to perform any type of movement of the device <NUM> within a selected target vessel. For example, the instructions <NUM> may instruct an operator to push the device <NUM> a given distance along the selected target vessel. A visualization <NUM> corresponding to the instructions <NUM> may also be displayed on the display <NUM>. In the example of <FIG>, the visualization <NUM> includes a blue line <NUM> with arrows showing the direction in which the pullback procedure should be performed. The visualization <NUM> may include visual effects such as changing colors or animation. For example, the arrows of the visualization <NUM> may move in the direction specified by the instructions <NUM>. The instructions <NUM> and visualization <NUM> may vary depending on options that were previously selected. For example, if an operator selected the RCA as the target vessel, the visualization <NUM> of the RCA would be highlighted and a corresponding visualization would be displayed showing a procedure outlined by instructions <NUM>.

In some embodiments, the instructions <NUM> of the display <NUM> may vary depending on which option <NUM>, <NUM> was selected from the prompt <NUM> shown in <FIG>. For example, if the post-stent check option <NUM> was selected, the instructions may read "please perform pullback from the distal point of the stent to the proximal point of the stent. " Other instructions may also be included to guide the operator to perform an imaging procedure and acquire imaging data relevant to the selected target vessel and/or stent.

<FIG> shows an exemplary display <NUM> showing a prompt <NUM> according to aspects of the present disclosure. The prompt <NUM> may be displayed after the operator has made a selection on the prompt <NUM> shown in <FIG>. In the example of <FIG>, the LAD artery has been selected by an operator. The prompt <NUM> may be accompanied by a visualization <NUM>. In some embodiments, the visualization <NUM> shows imaging data from the device <NUM> as the device <NUM> is moved through the selected target vessel. The imaging data may be used as a reference for the operator. In particular, imaging data shown in the visualization <NUM> may help the operator to know where to begin a procedure. In the example of <FIG>, the imaging data may show when the device <NUM> is positioned at a distal end of the LAD artery so that a pullback operation may be performed. The imaging data may also show other reference data such as areas of interest along a lumen <NUM>, branches of the lumen <NUM>, problem areas within the lumen <NUM>, and other features. In some embodiments, when the device <NUM> is placed at the location specified by the instructions (for example, at a distal portion of an artery), the operator may select the record button <NUM> to begin a recording of the procedure. The display may also include an option <NUM> to save specific frames of imaging data before or during a procedure.

<FIG> shows an exemplary visualization <NUM> according to aspects of the present disclosure. The visualization <NUM> may be displayed on a monitor <NUM>. The visualization <NUM> may present imaging data acquired by the device <NUM> during an intraluminal procedure. In some embodiments, the intraluminal procedure is outlined in the instructions shown in <FIG>. In some embodiments, the visualization <NUM> includes imaging data corresponding to a lumen <NUM>, such as the selected target vessel. The visualization <NUM> may include a first view <NUM> and a second view <NUM> of the lumen <NUM>. In some embodiments, the first and second views <NUM>, <NUM> may be oriented <NUM> degrees apart. In the example of <FIG>, the first view <NUM> shows imaging data corresponding to a view straight down the lumen <NUM> (otherwise discussed as a "transverse view") and the second view <NUM> shows imaging data corresponding to a longitudinal view of the lumen <NUM>. The views <NUM>, <NUM> may include corresponding imaging data. The display of the first view <NUM> and second view <NUM> is not shown in this manner in existing systems. In some embodiments, the first view <NUM> and the second view <NUM> are automatically chosen by the system to highlight important aspects of the image, such an MLA, landing spot, stent border, or other feature of interest, such that the first view <NUM> and the second view <NUM> display these features in a simple graphical way to the user. Other views may also be shown, including one or more transverse, cross-sectional, and tomographic images.

In some embodiments, the visualization <NUM> may include a selected frame of imaging data received by the device <NUM>. The operator may be able to select any frame from the imaging data received by the device <NUM>. This may allow the operator to focus on specific areas of interest in the lumen <NUM>.

In some embodiments, measurements are performed automatically on the imaging data with a controller of the intraluminal imaging system <NUM> as the imaging data is acquired by the device <NUM>. Existing imaging systems typically require an operator to manually select a frame of interest and mark areas for measurement. This may be a time-consuming process, and may introduce user errors and require a high level of expertise, especially in marking areas for measurement. These errors may cause operators to miss important features within the imaging data, such as lesions. The intraluminal imaging system <NUM> provides automated measurement of features in received imaging data without requiring user interaction. In some embodiments, the system <NUM> may automatically measure all applicable boundaries in the imaging data (including on a displayed image), including anatomical boundaries (such as lumen boundaries, vessel boundaries, lesion boundaries, aneurism boundaries, and other tissue layer boundaries) and stents. Furthermore, the system <NUM> may automatically identify areas of interest based on the automatic measurements and display these areas of interest, correlated to a longitudinal view or angiographic image of the lumen. This automatic measurement, analysis, and display may provide an easy to understand overview of the condition of the vessel or arty of the patient, as well as providing data for determining the severity and extent of lesions therein.

In the example of <FIG>, automatic measurements corresponding to a vessel boundary <NUM> and a minimum lumen area (MLA) <NUM> are displayed on the first view <NUM>. The measurements may also include lumen or vessel diameter, lumen or vessel area, lumen or vessel eccentricity, center measurements of the lumen or vessel, lumen or vessel boundary thickness, and other measurements performed automatically by the controller. These measurements may also be shown on other views. For example, a marker <NUM> is placed at the MLA in the second view <NUM> that corresponds with the lumen border <NUM> of the MLA in the first view <NUM>. This may help an operator to visualize the diameter of vessel boundaries along the lumen <NUM>. The measurements may be displayed in numerical format at box <NUM> on the visualization <NUM>. Specific portions and views of the visualization <NUM> may be viewed by an operator by selecting the options <NUM>, <NUM>, and <NUM>.

Measurements and/or metrics corresponding to the imaging data may be performed automatically by the intravascular imaging system and displayed by the visualization <NUM>. For example, the intraluminal imaging system <NUM> may be used to perform length measurements such as minimum, maximum, average, and mean lengths of features in the imaging data. The effective diameter of features may also be measured. Area measurements of features such as lumens, vessels, plaque, and thrombus may be performed by the intraluminal imaging system <NUM>. The measurements may include plaque burden, percent stenosis, percent difference, diameter stenosis, percent diameter stenosis, luminal gain, and luminal gain percentage. Furthermore, features of a stent may also be measured by the intraluminal imaging system <NUM>, including overall stent area, minimum stent area, average stent area, stent apposition, expansion, malapposition, and a stent score. The visualization <NUM> can include numerical values of one or more of these measurements or other graphical representations (e.g., shading, coloring, etc.), including graphical representations overlaid on or displayed separately/spaced from tomographic, longitudinal, and/or angiographic images of a vessel.

<FIG> shows an exemplary visualization <NUM> showing a lesion view according to aspects of the present disclosure. In some embodiments, visualization <NUM> corresponds to the pre-stent plan option <NUM> as shown in <FIG>. In some embodiments, the visualization <NUM> may be used to recommend the placement and size of a stent to address a lesion. These recommendations may be made automatically by the system <NUM> based on the imaging data received by the device <NUM>. In particular, the visualization <NUM> may be used to visualize a portion of a lumen <NUM> with a potential "landing spot" <NUM> for a stent. In some embodiments, the landing spot <NUM> is an area of interest within the lumen <NUM> that includes an MLA of a portion of the lumen <NUM>, as marked by marker <NUM>. The landing spot <NUM> may mark an area of the lumen recommended for treatment, such as placing a stent or positioning a balloon. The landing spot <NUM> may be automatically recommended by the system <NUM> based on the received imaging data received by the device <NUM>. The landing spot <NUM> may be shown in profile in view <NUM> to show the potential placement of the stent within the landing spot <NUM>. A distal end marker <NUM> and a proximal end marker <NUM> of the landing spot <NUM> may define the recommended placement of a distal and proximal edge of a stent to be placed in the lumen. The distal end marker <NUM> and proximal end marker <NUM> may be accompanied with numerical data <NUM>, <NUM> illustrating the average diameter and plaque burden of the lumen <NUM> at these locations. In some embodiments, the visualization may also a depiction of the plaque burden <NUM> along the lumen <NUM>. In some embodiments, the depiction of the plaque burden <NUM> is automatically measured based on imaging data from the device <NUM>. The visualization <NUM> may also include a depiction of lumen area <NUM>. As illustrated in <FIG>, the marker <NUM> for the MLA may be placed where the plaque burden is the greatest and the area of the lumen is the smallest.

In some embodiments, the visualization <NUM> includes a recommended stent diameter as shown in text box <NUM>. This diameter may be based on the diameter of the lumen <NUM> as measured by the system <NUM>.

<FIG> shows an exemplary visualization <NUM> according to aspects of the present disclosure. The visualization <NUM> may be generated by the system <NUM> and displayed on a monitor <NUM>. The visualization <NUM> may include a longitudinal view <NUM> of a lumen and a transverse view <NUM> of a lumen. In some embodiments, the views <NUM>, <NUM> of the lumen include intraluminal imaging data, such as IVUS data received from a device <NUM> as shown in <FIG>. The longitudinal view <NUM> of the lumen may be selected from an option list <NUM> including a classic longitudinal view <NUM> (as shown in <FIG>), a percent stenosis view <NUM> (as shown in <FIG>), a landing spot view <NUM> (as shown in <FIG>), and a 2D/3D hybrid view <NUM> (as shown in <FIG>). The user may select any of the options of the option list <NUM> to view the corresponding longitudinal view <NUM>. The transverse view <NUM> may also be referred to a 2D tomographic view, and may correspond to a position along the longitudinal view <NUM>, such as at a minimum lumen area (MLA). Various reference points <NUM>, <NUM>, <NUM> may be displayed on the longitudinal view <NUM>, including a distal reference point <NUM>, a MLA reference point <NUM>, and a proximal reference point <NUM>.

The system <NUM> may automatically identify landmarks (or key luminal areas) within the views <NUM>, <NUM> of the visualization <NUM>. In some embodiments, the system <NUM> may automatically detect landmarks within each frame of the views <NUM>, <NUM> and measure the dimensions of these landmarks. For example, the system may automatically detect and measure the diameter of and area within a vessel border <NUM> and a lumen border <NUM> of the lumen in the transverse view <NUM>, as well as the length of the lumen in the longitudinal view <NUM>. These measurements may be used to automatically identify one or more lesions within the lumen. For example, the MLA reference point <NUM> may be identified as a lesion, and the distal and proximal reference points <NUM>, <NUM> may be identified as a distal and proximal edge of the lesion, respectively.

The area between the vessel border <NUM> and the lumen border <NUM> may be shown as highlighted area <NUM>. These automatic measurements may be displayed on the visualization <NUM>, such as in text boxes <NUM>, <NUM>. A user may select a view report icon <NUM> to view a report including all of the calculated measurements. This icon <NUM> may be used to automatically store the measurement in file of the patient.

<FIG> shows an exemplary visualization <NUM> according to aspects of the present disclosure. The visualization <NUM> may be generated by the system <NUM> and displayed on a monitor <NUM>. The visualization <NUM> may include a longitudinal view <NUM> and a transverse (or cross-sectional) view <NUM> of a lumen. In some embodiments, the longitudinal view <NUM> may be a percent stenosis longitudinal view <NUM>, such that the system <NUM> is configured to automatically calculate a percent stenosis across the lumen or a segment of the lumen compared to a reference frame. For example, the system <NUM> has automatically measured each frame of imaging data in visualization <NUM> to determine the percent stenosis across the entire lumen as <NUM>% and across the segment between the distal reference point <NUM> and the proximal reference point <NUM> as <NUM>% (as shown in text box <NUM>). The visualization <NUM> may also display the percent stenosis at the distal, MLA, and proximal reference points <NUM>, <NUM>, <NUM>. These features may also be manually adjusted by the user.

In some embodiments, the position of the transverse view <NUM> may be manually selected by a user. For example, a sliding reference point <NUM> may be included in the longitudinal view <NUM> that may show the position of the transverse view <NUM>. The user may slide this sliding reference point <NUM> to view any position along the length of the lumen. The position of the sliding reference point <NUM> along the lumen may be displayed in text box <NUM>, as well as the area and diameter of the lumen at the sliding reference point <NUM>.

<FIG> shows an exemplary visualization <NUM> according to aspects of the present disclosure. The visualization <NUM> may be generated by the system <NUM> and displayed on a monitor <NUM>. The visualization <NUM> may include a longitudinal view <NUM> and a transverse view <NUM> of a lumen. In some embodiments, the longitudinal view <NUM> may be a "landing spot" longitudinal view <NUM>, such that the system <NUM> is configured to automatically identify a lumen and recommend a landing spot for placement of a stent. In the example of <FIG>, the system <NUM> has automatically identified an MLA reference point <NUM> as the center of a lesion within the lumen. The visualization <NUM> includes a recommended landing spot <NUM> based on the position of the detected lesion. The edges of the recommended landing spot <NUM> may be marked by distal and proximal reference points <NUM>, <NUM>. These points <NUM>, <NUM> may be manually adjusted by the user.

<FIG> shows an exemplary visualization <NUM> according to the present invention. The visualization <NUM> is generated by the system <NUM> and displayed on a monitor <NUM>. The visualization <NUM> is configured such that it can display a longitudinal view <NUM> and a 2D/3D hybrid view <NUM>. In some embodiments, a user is able to select the 2D/3D hybrid view option <NUM>, or use a control button or handle to display the 2D/3D hybrid view <NUM> on the monitor <NUM>. In some embodiments, a transverse view <NUM> (or 2D tomographic view), such as that shown in <FIG>, may be used to generate the 2D/3D hybrid view <NUM> based on a selection of the user. The 2D/3D hybrid view <NUM> may be generated by the system <NUM> by combining measurements of the lumen or vessel borders from a plurality of image frames. In some embodiments, the 2D/3D hybrid view <NUM> is generated using <NUM>-<NUM>,<NUM> image frames. In other embodiments, the 2D/3D hybrid view <NUM> is generated using <NUM>-<NUM> image frames, <NUM>-<NUM> image frames, <NUM>-<NUM>,<NUM> image frames, <NUM>,<NUM>-<NUM>,<NUM> image frames, or <NUM>,<NUM>-<NUM>,<NUM> image frames. In some embodiments, the 2D/3D hybrid view <NUM> includes a transverse view <NUM> of the lumen and a 3D portion <NUM> extending out from the transverse view <NUM>. The 2D/3D hybrid view <NUM> may include a lumen border <NUM> in the transverse view <NUM> and extending into the 3D portion <NUM> of the view <NUM>. The 2D/3D hybrid view <NUM> may include indicators <NUM>, <NUM> corresponding to positions on the longitudinal view <NUM> (such as the MLA reference point <NUM> and the proximal reference point <NUM>). The 2D/3D hybrid view <NUM> may also include any of key luminal areas or landmarks as discussed above. In some embodiments, the 2D/3D hybrid view <NUM> may rotated or enlarged by a user to view different regions of the lumen. The user may also select different positions along the longitudinal view <NUM> as the starting point of the 2D/3D hybrid view (such as showing a transverse view <NUM> corresponding to the MLA or distal reference points <NUM>, <NUM>). The 2D/3D hybrid view <NUM> may provide a user a view of imaging data along the length of the lumen that is easy to understand.

<FIG> is a flow diagram of a method <NUM> of providing intraluminal imaging to measuring and display features in a lumen to a user. In some embodiments, the steps of the method <NUM> may be carried out by the intraluminal imaging system <NUM> and associated components as shown in <FIG> and any of the displays as shown in <FIG>. It is understood that the steps of method <NUM> may be performed in a different order than shown in <FIG>, additional steps can be provided before, during, and after the steps, and/or some of the steps described can be replaced or eliminated in other embodiments.

At step <NUM>, the method <NUM> may include providing a prompt to navigate an intraluminal imaging device within a lumen. The intraluminal imaging device may be the intraluminal imaging device <NUM> as shown in <FIG>. The prompt may include navigating the intraluminal imaging device to a starting point in the lumen, as well as activating sensors in the intraluminal device. This prompt may be presented with text as well as images showing where the user should place the intraluminal device.

At step <NUM>, the method <NUM> may include receiving imaging data from the intraluminal device. This imaging data may help a user to accurately navigate the intraluminal device according to the prompt of step <NUM>. For example, if the prompt of step <NUM> directs the user to navigate the intraluminal device from a distal end of the lumen to a proximal end of the lumen, the imaging data may show imaging data from the intraluminal device as it is moved through the lumen. In some embodiments, the imaging data may include IVUS data showing the layers of tissue on the interior of the lumen. In other embodiments, the imaging data includes data from another modality such as angiographic image data. This data may be used to compile an angiographic image of the lumen. Thus, the imaging data may help the user to accurately perform the operation outlined in the prompt.

At step <NUM>, the method <NUM> may include generating a set of image frames of the lumen using the received imaging data. In some embodiments, the set of image frames are IVUS images showing 2D tomographic image slices of the lumen (i.e., showing a transverse view of the lumen), as shown in <FIG>. In other embodiments, the image frames are generated with another imaging modality, such as OCT, ICE, FLICE, ultrasound, fluoroscopy, radiography, angiography, other medical imaging modalities, or combinations thereof. Each image frame may be correlated to a particular location along the length of the lumen.

At step <NUM>, the method <NUM> may include automatically measuring features in the image frames. A controller of the system may automatically identify and measure these features based on imaging data. The measured features in the image frames may include anatomical features such as tissue boundaries (such as lumen and vessel boundaries), lesions, aneurisms, bifurcations, as well as manmade features such as stents. The automatic measurements may include lumen or vessel diameter, lumen or vessel area, lumen or vessel eccentricity, center measurements of the lumen or vessel, lumen or vessel boundary thickness, pressure measurements, percent stenosis, malapposition areas, landing spots, and other measurements performed by the controller. In some embodiments, the system identifies a lesion within the lumen and automatically measures at least three points of the lesion: a proximal reference point, a distal reference point, and a MLA. In some embodiments, the controller identifies the features based on variations in the imaging data, such as changes in brightness, speckle patterns, regions with similar shapes, linear or curved features, as well as other variations. In some embodiments, the controller identifies the features based on previous user testing, clinical trials, published guidelines, and consensus in the medical field. The automatic measurements of the system may be manually adjusted or edited by the user. For example, the user may change a lumen boundary to correct an error in measurement.

At step <NUM>, the method <NUM> may include displaying a view of the lumen based on the set of image frames on a display device. The display device may be a monitor <NUM> as shown in <FIG>. The view of the lumen may include a transverse, longitudinal, and/or 2D/3D hybrid view of the lumen, such as those shown in <FIG>. In some embodiments, two or more views of the lumen are shown on a same screen of the display device. For example, a transverse intraluminal view of the lumen may be shown with a longitudinal view of the lumen. A 2D/3D hybrid view of the lumen may be shown with a transverse view at one end, as shown in <FIG>. In some embodiments, a segment of the lumen is shown head-on (i.e., a transverse view) to assess various frames of the lumen and a separate cross-sectional display (i.e., longitudinal view) is displayed adjacent to the head-on view. The views of the lumen may be visually correlated, such that a user can easily understand which portions of the lumen are being displayed. In some embodiments, the views may be visually correlated by similar colors, patterns, indicators, or symbols. This correlation may help a user to more easily understand the context for each view displayed on the display device. The user may be able to access other views on the display by selecting areas of the displayed views. For example, the user may scroll through the various image frames of the lumen by sliding an indicator along a longitudinal view of the lumen. Furthermore, the display may show a 2D/3D hybrid view of the lumen and the user may be able to select various positions along the 3D extension of the view to access 2D transverse views at the selected positions. In some embodiments, the user is presented with selectable options to view various longitudinal views of the lesion including a classic longitudinal view (such as that shown in <FIG>), a percent stenosis longitudinal view (such as that shown in <FIG>), a landing spot longitudinal view (such as that shown in <FIG>), and a 2D/3D hybrid view (such as that shown in <FIG>). The user may toggle through these options and view transverse views corresponding to locations on the various longitudinal views.

Claim 1:
An intraluminal medical imaging system, comprising:
a controller in communication with an intraluminal imaging device configured to be positioned within a body lumen of a patient, the controller configured to:
receive imaging data from the intraluminal imaging device as it is moved through the body lumen of the patient;
generate a set of image frames using the received imaging data;
automatically calculate a luminal area associated with the body lumen for each of the image frames; and
a display device in communication with the controller and configured to display, on a single screen, a hybrid two-dimensional/three-dimensional image including a first image frame of the set of image frames and a 3D-depiction of a portion of the body lumen extending out from the first image frame, wherein the first image frame is a two-dimensional tomographic image of the body lumen referred to as a transverse view of the body lumen, the calculated luminal area corresponding to the first image frame, and a longitudinal view of the body lumen.