Patent Description:
Various types of 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 assessing a diseased vessel, such as an artery, within the human body to determine the need for treatment, to guide the intervention, and/or to assess its effectiveness. An IVUS device including one or more ultrasound transducers is passed into the vessel and guided to the area to be imaged. The transducers emit ultrasonic energy and receive ultrasound echoes reflected from the vessel. The ultrasound echoes are processed to create an image of the vessel of interest. The advent of faster computational analysis has increased the effectiveness of intravascular imaging systems. However, existing intravascular imaging systems typically require operators to have a high degree of skill and experience to safely operate intravascular devices. For example, depending on the type of operation, the performance of an intravascular procedure may include many steps including maneuvering devices, measurements, and analysis of results. An operator must know and complete all of these steps to successfully perform the procedure. The large number and complexity of steps may make these procedures difficult to perform and may cause errors in the procedures.

A document <CIT> discloses an image display device that accesses a storage unit in which are stored a plurality of blood vessel tomograms acquired while a probe is moved in the axial direction of a catheter, and a plurality of X-ray images captured while the probe is moving, acquires an X-ray image of a display object from the plurality of X-ray images, and specifies a blood vessel tomogram from the plurality of blood vessel tomograms. The image display device determines a position corresponding to the acquisition position of the specified blood vessel tomogram on a blood vessel view corresponding to the blood vessel to which the probe was moved in the acquired X-ray image, displays a predetermined figure in superposed fashion on the X-ray image in order to indicate the determined position, and displays information based on cross-section information correlated with the specified blood vessel tomogram. Another document <CIT> discloses an intravascular filter wherein at least a portion of the filter has been modified to provide an enhanced echogenic characteristic of the filter. Also described are systems for positioning a variety of intravascular filters within the vasculature wherein the systems include an intravascular filter, an intravascular ultrasound transducer, a user interface configured to receive input from an operator regarding a surgical procedure including an insertion site and a destination site for positioning the filter according to the surgical procedure, a display, and a processor. Another document <CIT> discloses a method for real-time displaying of cross-sectional images during an intravascular ultrasound imaging procedure that includes, during an intravascular ultrasound imaging procedure, receiving electrical signals from at least one transducer in a catheter as the at least one transducer rotates and moves longitudinally along a lumen of a patient blood vessel; during the intravascular ultrasound imaging procedure, processing the received electrical signals to form a series of cross-sectional images that are longitudinally-offset from one another along a length of the lumen; during the intravascular ultrasound imaging procedure, concurrently displaying i) a most recent image and ii) a previous image that is either a) selected by the operator or b) automatically selected as having a maximum or minimum of a selected image characteristic; and, during the intravascular ultrasound imaging procedure, updating the display of the most recent image as a new image from the series of cross-sectional images is processed.

Systems, devices, and methods for providing instructions for an operator of an intravascular imaging system are provided. The intravascular imaging system may include a controller configured to provide a selectable options on a display device to select a target vessel, identify an area of interest within the selected target vessel based on the received imaging data, and automatically display, in response to identifying the area of interest, vessel measurements corresponding with the area of interest on the display device. Aspects of the present disclosure advantageously provide complete end-to-end workflow solutions that overcome the limitations of existing intravascular imaging systems.

Embodiments of the present disclosure provide an intravascular imaging system, which may include: a controller in communication with an intravascular imaging device, the controller configured to: provide, on a display device in communication with the controller, a selectable option to select a target vessel; provide a prompt to move the intravascular imaging device within the selected target vessel; receive imaging data from an imaging sensor during movement of the intravascular imaging device within the selected target vessel; identify an area of interest within the selected target vessel based on the received imaging data; and automatically display, in response to identifying the area of interest, vessel measurements corresponding with the area of interest on the display device.

In embodiments, the intravascular imaging system further includes the intravascular imaging device, including: a flexible elongate member configured to be inserted into the target vessel of a patient; the imaging sensor disposed on a distal portion of the flexible elongate member; and the display device. The controller may be further configured to provide a selectable option on the display device to perform a pre-stent procedure or a post-stent check. The controller may be further configured to automatically measure a diameter of the vessel within the area of interest, determine a first location within the area of interest with a minimum diameter, and display the first location and the minimum diameter on the display device.

In some embodiments, the display of the vessel measurements is configured to allow a user to edit a depiction of a border of the vessel. The display of the vessel measurements may include a first view and a second view of the area of interest different from the first view. A user's edit to the depiction of the border of the vessel may be displayed in the first view and the second view of the area of interest. The display of the vessel measurements may include a depiction of a target area for a stent if a user selects the pre-stent procedure option. The display of the vessel measurements may include a depiction of a stent if a user selects the post-stent check option. The display of the vessel measurements may further include a depiction of a stent malapposition.

A method of intravascular imaging is also provided, which may include: providing, with a controller in communication with an intravascular imaging device, a selectable option on a display device to select a target vessel within a patient; providing, with the controller, a prompt to move the intravascular imaging device in the selected target vessel on the display device; receiving, with the controller, imaging data from an imaging sensor while the intravascular imaging device is moved within the selected target vessel; identifying, with the controller, an area of interest within the selected target vessel based on the received imaging data; and displaying automatically, with the display device, vessel measurements corresponding with the area of interest.

The method may also include providing, with a controller, a selectable option on a display device to perform a pre-stent procedure or a post-stent check. The method may include measuring, with the controller, a diameter of the vessel within the area of interest, identifying a first location with a minimum diameter within the area of interest; and displaying the first location and minimum diameter on the display device. The method may include providing, with the controller, an option to edit a depiction of a border of the vessel on the display device.

In some embodiments, the display of the vessel measurements includes a first view and a second view of the area of interest different from the first view. The method may include displaying an edit to the depiction of the border of the vessel in the first view and the second view of the area of interest. The method may include displaying the edit to the depiction of the border of the vessel in a third view different from the first view and the second view. The display of the vessel measurements may include a depiction of a target area for a stent if a user selects the pre-stent procedure option. The display of the vessel measurements may include a depiction of a stent if a user selects the post-stent check option. The display of the vessel measurements further may include a depiction of a stent malapposition.

<FIG> is a diagrammatic schematic view of an intravascular imaging system <NUM>, according to aspects of the present disclosure. The intravascular imaging system <NUM> may include an intravascular device <NUM>, a patient interface module (PIM) <NUM>, a console or processing system <NUM>, and a display device or monitor <NUM>. The intravascular device <NUM> may be sized and shaped, and/or otherwise structurally arranged or configured to be positioned within a body lumen <NUM> of a patient. For example, the intravascular 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>.

The intravascular imaging system <NUM> (or intraluminal imaging system) can be any type of imaging system suitable for use in the lumens or vasculature of a patient. In some embodiments, the intravascular imaging system <NUM> is an intravascular ultrasound (IVUS) imaging system. In other embodiments, the intravascular imaging system <NUM> may include systems configured for forward looking intravascular ultrasound (FL-IVUS) imaging, intravascular 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 intravascular 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 a imaging element to obtain intravascular 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), intravascular 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), intravascular 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 intravascular 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 intravascular device <NUM> emits ultrasonic energy from a transducer array <NUM> included in scanner assembly <NUM> mounted near a distal end of the intravascular 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 intravascular 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 intravascular 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 intravascular device <NUM>. This communication may include providing commands to integrated circuit controller chip(s) within the intravascular 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 intravascular device <NUM> including circuitry within the scanner assembly <NUM>.

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 processing system or controller <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 processing system or controller <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 intravascular 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 intravascular device <NUM> my include the scanner assembly <NUM> near a distal end of the intravascular device <NUM> and a transmission line bundle <NUM> extending along the longitudinal body of the intravascular 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 intravascular device <NUM>. The PIM connector <NUM> electrically couples the transmission line bundle <NUM> to the PIM <NUM> and physically couples the intravascular device <NUM> to the PIM <NUM>. In an embodiment, the intravascular device <NUM> further includes a guidewire exit port <NUM>. Accordingly, in some instances the intravascular 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 intravascular 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 intravascular 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 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 intravascular 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 intravascular 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, 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 workflow for a pre-stent plan that may include performing an intravascular procedure (such as a pullback operation) and viewing 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 workflow for a post-stent check that may include performing an intravascular procedure (such as a pullback operation) and viewing results of an area within a lumen <NUM> where a stent has previously been placed. 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. The colors, shading, textures, and other graphical properties of the display <NUM> may be chosen to highlight specific features. 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 a contrasting color (e.g., blue, red, or another color), shaded, shown with a texture, or otherwise highlighted.

<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 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>.

The instructions <NUM> of the display <NUM> 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>, or 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 intravascular procedure. In some embodiments, the intravascular 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 "longitudinal view") and the second view <NUM> shows imaging data corresponding to a transverse view of the lumen <NUM>. In other embodiments, other views may also be shown. For example, in <FIG>, three different views are shown, including a third view <NUM> showing a three dimensional sectional view of the lumen <NUM>. The views <NUM>, <NUM> may include corresponding imaging data.

In some embodiments, the visualization <NUM> may include a selected frame of imaging data received by the device <NUM>. For example, text box <NUM> states that the visualization <NUM> corresponds to frame <NUM> in the example of <FIG>. 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 intravascular imaging system <NUM> as the imaging data is acquired by the device <NUM>. In the example of <FIG>, 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 a vessel diameter, a center of the vessel, a vessel boundary <NUM> 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 MLA <NUM> 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>. In some embodiments, option <NUM> corresponds with the visualization <NUM> shown in <FIG>, option <NUM> corresponds with the visualization <NUM> shown in <FIG>, and option <NUM> corresponds with the visualization <NUM> shown in <FIG>. An operator may select option <NUM> to view a longitudinal view of the lumen <NUM>, option <NUM> to view a view of a lesion in the lumen <NUM>, and option <NUM> to view a stent and surrounding portion of the lumen <NUM>. In some embodiments, the primary view or first view <NUM> of each option <NUM>, <NUM>, <NUM> is accompanied by a transverse view <NUM> of the lumen <NUM> as shown in <FIG>, <FIG>, and <FIG>.

<FIG> show an exemplary display <NUM> with various views showing imaging data according to aspects of the present disclosure. The display <NUM> may be displayed on the monitor <NUM>. <FIG> shows a display <NUM> with three different views <NUM>, <NUM>, <NUM> of imaging data. In some embodiments, view <NUM> is a longitudinal view of a lumen <NUM>, view <NUM> is a three dimensional cross section of the lumen <NUM>, and view <NUM> is a transverse view of the lumen <NUM>. The views <NUM> may include visualization of boundaries <NUM>, <NUM>, <NUM>, <NUM> of aspects of the lumen. For example, boundary <NUM> may represent a vessel boundary, boundary <NUM> may represent a MLA of a portion of the lumen <NUM>, boundary <NUM> may represent a central area of the lumen <NUM> and boundary <NUM> may represent a three dimensional vessel boundary. Furthermore, planes <NUM> and <NUM> may represent planes along which view <NUM> is viewed. The boundaries <NUM>, <NUM>, <NUM>, <NUM> in one view may correspond with the boundaries <NUM>, <NUM>, <NUM>, <NUM> in the other views <NUM>, <NUM>, <NUM> of the display <NUM>. The presentation of different views may help an operator to visualize the size and shape of portions of the lumen <NUM>.

<FIG> shows an exemplary display <NUM> with a function to allow the operator to edit one or more of the visualization of the boundaries <NUM>, <NUM>, <NUM>, <NUM>. In the example of <FIG>, the operator may use a tool <NUM> to select a boundary to move (in this case, boundary <NUM>). The selected boundary may appear as a dotted line. The boundary may be moved in any direction. In the example of <FIG>, an arrow <NUM> shows the direction that the boundary is moved (i.e., in an outward direction). A corresponding movement of the boundary is also shown in views <NUM>, <NUM>, along with arrows <NUM> to show the direction of movement. The operator may move the boundaries <NUM>, <NUM>, <NUM>, <NUM> to correct errors in imaging data or to visualize potential outcomes of procedures (such as inserting a stent in a lumen <NUM>).

<FIG> shows an exemplary display <NUM> after the boundary <NUM> has been moved to a new location at boundary <NUM>. As discussed above, the views <NUM>, <NUM>, <NUM> show corresponding boundaries <NUM>, <NUM> that an operator can view together to better understand the shape of a portion of a lumen <NUM>.

<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 zone" <NUM> for a stent. In some embodiments, the landing zone <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 zone <NUM> may be shown in profile in view <NUM> to show the potential placement of the stent within the landing zone <NUM>. A distal end marker <NUM> and a proximal end marker <NUM> of the landing zone <NUM> may define the distal and proximal extent of a potential stent. 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> showing a stent check view according to aspects of the present disclosure. In some embodiments, the visualization <NUM> is shown after the operator has selected the stent check option <NUM> and has been guided through the subsequent workflow steps. The visualization <NUM> may display imaging data gathered from the device <NUM> during motion within a lumen <NUM> (such as a pullback procedure) where a stent has been placed, as well as imaging data of surrounding areas of the lumen.

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 intravascular 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 intravascular 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 intravascular 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.

In some embodiments, the shape and size of a lumen boundary <NUM> may be measured and displayed, as well a boundary of the stent <NUM>. As in <FIG> and <FIG>, the boundaries may be visualized in a first view <NUM> as well as a second view <NUM>. The visualization <NUM> may also include measurements of the length of the stent. For example, the visualization <NUM> may include a distal reference marker <NUM> and may include a depiction <NUM> of the stent. The average diameter and plaque burden at the distal reference marker may be shown in text box <NUM>. The minimum stent area (MSA) may also be automatically measured and displayed in the text box <NUM> as well as with MSA marker <NUM>.

In some embodiments, the visualization <NUM> may be used to determine the effectiveness of a stent. For example, the visualization <NUM> may include measurements and depictions of any malapposition of the stent. The malapposition areas <NUM>, <NUM> may be shown in both the first view <NUM> and the second view <NUM> so that an operator can better visualize the malapposition. The malapposition areas <NUM>, <NUM> may have a different color than other imaging data (such as red) to highlight this feature. In some embodiments, the malapposition areas <NUM>, <NUM> are measured automatically using the imaging data collected by the device <NUM> during a pullback procedure of the stent. The visualization <NUM> may also include an expansion score <NUM>. In the example of <FIG>, the expansion score is <NUM>%. This may signify that the stent is mostly expanded to contact the lumen <NUM>, but a malapposition is present. In some embodiments, the expansion score may vary from <NUM>% (where a stent is not yet extended within the stent ) to <NUM>% (where a stent is completely expanded and no malappositions are present). The expansion score <NUM> may be determined automatically with the controller of the system <NUM> by comparing measurements of the border of the stent <NUM> to the borders of the lumen. In some embodiments, the expansion score <NUM> is also based on the plaque burden and lumen area within the vessel.

<FIG> is a flow diagram of a method <NUM> of proving a guided workflow for an intravascular imaging procedure to a user. In some embodiments, the steps of the method <NUM> may be carried out by the intravascular imaging system <NUM> and associated components 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 guided workflow to a user. The guided workflow may be provided as a series of prompts, instructions, and visualizations that are displayed on a display device, such as monitor <NUM> as shown in <FIG>. The guided workflow may help a user to easily and accurately perform each step of an intravascular imaging procedure. The guided workflow may present different options based on the selections of the user and may include checks of previous steps to ensure that all steps of the procedure have been performed.

At step <NUM>, the method may include providing a selectable option for a pre-stent plan or a post-stent check. The selectable option may be provided on a display such as display <NUM> as shown in <FIG>. The selectable option for the pre-stent plan may include performing an intravascular imaging procedure to visualize a vessel or lumen before inserting a stent. The selectable option for the post-stent check may include performing an intravascular imaging procedure to check a stent that has been inserted in a vessel or lumen. Each selectable option may include a number of subsequent steps, as discussed below.

At step <NUM>, the method <NUM> may include providing an option to select a target vessel. This option may be presented visually, such as presenting various vessels on a diagram. In some embodiments, the target vessels are arteries within the heart, such as the RCA, LAD, and LCX. In other embodiments, the target vessels are other lumens within the body. This step <NUM> may involve providing feedback to a user, such as indicating which vessel has been selected. The feedback may include highlighting, coloring, shading or otherwise indicating the vessel that has been selected.

At step <NUM>, the method <NUM> may include providing a prompt to perform an operation within the selected target vessel. In some embodiments, this operation includes moving an intravascular device within the vessel. For example, the operation may be a pullback operation. In other embodiments, the operation may be an operation to push an intravascular device through a portion of a lumen. The prompt may be presented in text format and may include a visualization of the operation.

At step <NUM>, the method <NUM> may include providing a prompt to navigate an intravascular device to a starting point in the selected target vessel and activate sensors in the intravascular device. This prompt may be presented with text as well as images showing where the user should place the intravascular device. In some embodiments, the prompt of step <NUM> depends on the option selected at step <NUM>. For example, if the user selected the pre-stent plan option at step <NUM>, the prompt at step <NUM> may prompt the user to navigate the intravascular device from a most distal point of the target vessel to the ostium. If the user selected the post-stent check option at step <NUM>, the prompt at step <NUM> may prompt the user to navigate the intravascular device from a distal end of the stent to a proximal end of the stent.

At step <NUM>, the method <NUM> may include receiving imaging data from the intravascular device. This imaging data may help a user to accurately navigate the intravascular device according to the prompt of step <NUM>. For example, if the prompt of step <NUM> directs the user to navigate the intravascular device from a distal end of the stent to a proximal end of the stent, the imaging data may show imaging data from the intravascular device as it is moved to the distal end of the stent. In some embodiments, the imaging data may include IVUS data showing the layers of tissue on the interior of the vessel. In other embodiments, the imaging data includes data from another modality such as OCT. 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 displaying the imaging data as the intravascular device is moved during the operation. This imaging data may help a user to accurately perform the operation.

At step <NUM>, the method <NUM> may include identifying an area of interest using the imaging data. In some embodiment, the area of interest is identified based on imaging data such as border measurements, lumen area, plaque burden within the lumen, etc. The area of interest may include an MLA or MSA as shown in <FIG>, <FIG>, and <FIG>. In some embodiments, the area of interest includes a landing zone for stent placement or a stent that has been positioned in a lumen. The area of interest may be colored, highlighted, shaded, or otherwise indicated as an area of interest on a display of the imaging data. In some embodiments, the distal and proximal ends of the area of interest are shown as well as measurements of the size and position of the area of interest.

At step <NUM>, the method <NUM> may include displaying vessel measurements based on the imaging data corresponding with the area of interest. In some embodiments, vessel measurements such as vessel boundaries, stent boundaries, MLA, MSA, lumen area, plaque burden, and other measurements are displayed on the display. These measurements may be shown graphically (for example, by colored lines or regions) as well as textually (for example, in text boxes). The vessel measurements may also include recommendations (such as the recommended size and position of stents) and scores (such as stent expansion scores). The vessel measurements may allow a user to quickly identify problem areas within a lumen as well as possible solutions.

Claim 1:
An intravascular imaging system, comprising:
a controller (<NUM>) in communication with an intravascular imaging device (<NUM>), the controller (<NUM>) configured to:
provide a selectable option on the display device (<NUM>) to perform a pre-stent procedure (<NUM>) or a post-stent check (<NUM>);
provide, on a display device (<NUM>) in communication with the controller (<NUM>), a selectable option (<NUM>, <NUM>) to select a target vessel (RCA, LAD, LCX);
provide a prompt (<NUM>) comprising instructions (<NUM>) to move the intravascular imaging device within the selected target vessel, wherein the instructions (<NUM>) vary depending on whether the pre-stent procedure (<NUM>) or the post-stent check (<NUM>) is selected;
receive imaging data from an imaging sensor during movement of the intravascular imaging device within the selected target vessel (RCA, LAD, LCX);
identify an area of interest (<NUM>) within the selected target vessel (RCA, LAD, LCX) based on the received imaging data;
automatically display, in response to identifying the area of interest (<NUM>), vessel measurements (<NUM>) corresponding with the area of interest (<NUM>) on the display device (<NUM>);
display different views of imaging data, wherein one view is a longitudinal view of a lumen (<NUM>), another view (<NUM>) is a three dimensional cross section of the lumen and a further view is a transverse view of the lumen (<NUM>); and
display planes (<NUM>, <NUM>) representing planes along which one of the views (<NUM>) is viewed.