Intravascular imaging procedure-specific workflow guidance and associated devices, systems, and methods

Abstract

To solve such problems that, in an existing intravascular imaging system, an operator typically needs to have high-level skill and experience for safely operating an intravascular device, and it is difficult to execute a procedure and an error in a procedure may be caused if there are the large number of steps and the steps are complicated.SOLUTION: Systems, devices, and methods for providing procedure-specific workflow guidance are provided. The workflow guidance may include providing selectable options on a display device to a user including a selectable option to select a target vessel and a prompt to move an intravascular imaging device within the selected target vessel. Imaging data is received from the intravascular imaging device within the selected target vessel. The workflow guidance may be used to identify an area of interest within the selected target vessel and automatically display vessel measurements corresponding with the area of interest on the display device.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present disclosure relates generally to acquiring intravascular data related to a patient's body vessels, and more particularly to providing a user with a workflow for performing an intravascular imaging procedure using an intravascular imaging device. The workflow may be displayed to the user as prompts and instructions, as well as visualizations of imaging data from the intravascular imaging device. [Background technology]

[0002] Various types of intravascular imaging systems are used in the diagnosis and treatment of disease. For example, intravascular ultrasound (IVUS) imaging is widely used in interventional cardiology as a diagnostic tool to evaluate diseased blood vessels, such as arteries, within the human body to determine the need for treatment, guide intervention, and / or evaluate its effectiveness. An IVUS device, containing one or more ultrasound transducers, is passed through the blood vessel and guided to the area to be imaged. The transducers emit ultrasound energy and receive ultrasound echoes reflected from the blood vessel. The ultrasound echoes are processed to generate an image of the blood vessel of interest. Summary of the Invention [Problem to be solved by the invention]

[0003] 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 level of skill and experience to safely operate the intravascular device. For example, depending on the type of surgery, performing an intravascular procedure can involve many steps, including maneuvering the device, taking measurements, and analyzing the results. The operator must know and complete all of these steps to successfully perform the procedure. The large number and complexity of steps makes these procedures difficult to perform and can lead to procedural errors. [Means for solving the problem]

[0004] Systems, devices, and methods are provided for providing instructions to an operator of an intravascular imaging system. The intravascular imaging system may include a controller configured to select a target vessel, identify a region of interest within the selected target vessel based on received imaging data, and, in response to identifying the region of interest, provide a selectable option on the display device to automatically display vascular measurements corresponding to the region of interest on the display device. Aspects of the present disclosure advantageously provide a complete end-to-end workflow solution that overcomes limitations of existing intravascular imaging systems.

[0005] An embodiment of the present disclosure provides an intravascular imaging system, which may include a controller in communication with an intravascular imaging device, the controller being configured to provide selectable options for selecting a target vessel on a display device in communication with the controller, provide prompts for moving the intravascular imaging device within the selected target vessel, receive imaging data from the imaging sensor during movement of the intravascular imaging device within the selected target vessel, identify a region of interest within the selected target vessel based on the received imaging data, and automatically display vascular measurements corresponding to the region of interest on the display device in response to identifying the region of interest.

[0006] In embodiments, the intravascular imaging system further includes an intravascular imaging device, and the intravascular imaging procedure includes a flexible elongate member configured to be inserted into a target vessel of a patient, an imaging sensor disposed at a distal portion of the flexible elongate member, and a display device. The controller may be further configured to provide selectable options 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 region of interest, determine a first location within the region of interest having a minimum diameter, and display the first location and the minimum diameter on the display device.

[0007] In some embodiments, the display of vascular measurements is configured to allow a user to edit the depiction of the vascular boundary. The display of vascular measurements may include a first view and a second view of the region of interest that is different from the first view. The user's edits to the depiction of the vascular boundary may be displayed in the first view and the second view of the region of interest. The display of vascular measurements may include a depiction of the stent target area if the user selects a pre-stent procedure option. The display of vascular measurements may include a depiction of the stent if the user selects a post-stent check option. The display of vascular measurements may further include a depiction of stent malapposition.

[0008] A method of intravascular imaging is also provided, which may include using a controller in communication with the intravascular imaging device to provide selectable options on a display device for selecting a target vessel within a patient; using the controller to provide prompts to move the intravascular imaging device within the selected target vessel on the display device; using the controller to receive imaging data from the imaging sensor while the intravascular imaging device is moved within the selected target vessel; using the controller to identify a region of interest within the selected target vessel based on the received imaging data; and using the display device to automatically display vascular measurements corresponding to the region of interest.

[0009] The method may also include using the controller to provide selectable options on the display device to perform a pre-stent procedure or a post-stent check. The method may include using the controller to measure a diameter of the blood vessel within the region of interest, identify a first location having a minimum diameter within the region of interest, and display the first location and the minimum diameter on the display device. The method may include using the controller to provide an option to edit a depiction of the blood vessel boundary on the display device.

[0010] In some embodiments, the display of vascular measurements includes a first view and a second view of the region of interest that is different from the first view. The method may include displaying edits to the depiction of the vessel boundary in the first and second views of the region of interest. The method may include displaying edits to the depiction of the vessel boundary in a third view that is different from the first and second views. The display of vascular measurements may include a depiction of the stent target area if the user selects a pre-stent procedure option. The display of vascular measurements may include a depiction of the stent if the user selects a post-stent check option. The display of vascular measurements may further include a depiction of stent malapposition.

[0011] Further aspects, features, and advantages of the present disclosure will become apparent from the following detailed description.

[0012] Exemplary embodiments of the present disclosure will be described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0013] [Figure 1] 1 is a schematic diagram of an intravascular imaging system according to aspects of the present disclosure. [Figure 2] 10A-10C are example diagrams of displays showing prompts according to aspects of the present disclosure. [Figure 3] FIG. 10 is an example diagram of a display showing another prompt according to aspects of the present disclosure. [Figure 4] FIG. 10 is an example diagram of a display showing another prompt and instruction according to an aspect of the present disclosure. [Figure 5] 1 is an exemplary diagram of a display showing imaging data and instructions according to aspects of the present disclosure. [Figure 6] 1 is an exemplary diagram of a display showing imaging data according to aspects of the present disclosure. [Figure 7A] 1A-1C are exemplary diagrams of displays illustrating various views of imaging data according to aspects of the present disclosure. [Figure 7B]10A-10C are exemplary diagrams of another display illustrating various views of imaging data according to aspects of the present disclosure. [Figure 7C] 10A-10C are exemplary diagrams of another display illustrating various views of imaging data according to aspects of the present disclosure. [Figure 8] 1 is an exemplary diagram of a display showing imaging data according to aspects of the present disclosure. [Figure 9] 1 is an exemplary diagram of a display showing imaging data according to aspects of the present disclosure. [Figure 10] FIG. 1 is a flow diagram of a method for providing a guided workflow according to an aspect of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0014] For purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation on the scope of the present disclosure is intended. Any changes and further modifications to the described apparatus, systems, and methods, and any further applications of the principles of the present disclosure, as would normally occur to one of ordinary skill in the art to which the present disclosure pertains, are fully contemplated and included within the present disclosure. In particular, it is fully contemplated that features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. However, for the sake of brevity, multiple iterations of these combinations will not be separately described.

[0015] 1 is a schematic diagram of an intravascular imaging system 100 according to an aspect of the present disclosure. The intravascular imaging system 100 may include an intravascular device 102, a patient interface module (PIM) 104, a console or processing system 106, and a display or monitor 108. The intravascular device 102 may be sized and shaped and / or otherwise structurally arranged or configured to be placed within a body cavity 120 of a patient. For example, the intravascular device 102 can be a catheter, a guidewire, a guide catheter, a pressure wire, and / or a flow wire in various embodiments. In some circumstances, the system 100 may include additional elements and / or may be implemented without one or more of the elements shown in FIG. 1 .

[0016] The devices, systems, and methods described herein may include one or more features described in co-filed U.S. Provisional Application __________ (Attorney Docket No. 2017PF02102), co-filed U.S. Provisional Application __________ (Attorney Docket No. 2017PF02103), co-filed U.S. Provisional Application __________ (Attorney Docket No. 2017PF02101), and co-filed U.S. Provisional Application __________ (Attorney Docket No. 2017PF02365), each of which is incorporated herein by reference in its entirety.

[0017] Intravascular imaging system 100 (or intraluminal imaging system) can be any type of imaging system suitable for use in a patient's lumen or vasculature. In some embodiments, intravascular imaging system 100 is an intravascular ultrasound (IVUS) imaging system. In other embodiments, intravascular imaging system 100 may include a system 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.

[0018] It is understood that system 100 and / or device 102 can be configured to acquire any suitable intravascular imaging data. In some embodiments, device 102 can include imaging components of any suitable imaging modality, such as optical imaging, optical coherence tomography (OCT), etc. In some embodiments, device 102 can include any suitable imaging components, including pressure sensors, flow sensors, temperature sensors, optical fibers, reflectors, mirrors, prisms, ablation elements, radio frequency (RF) electrodes, conductors, and / or combinations thereof. In general, device 102 can include an imaging element for acquiring intravascular data related to lumen 120. Device 102 can be sized and shaped (and / or configured) for insertion into a patient's blood vessel or lumen 120.

[0019] The system 100 may be located in a catheterization lab having a control room. The processing system 106 may be located in the control room. Optionally, the processing system 106 may be located elsewhere, such as in the catheterization lab itself. The catheterization lab may include a sterile field, while its associated control room may or may not be sterile depending on the procedure being performed and / or the medical facility. The catheterization lab 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, fractional flow reserve (FFR) determination, 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, the device 102 may be controlled from a remote location, such as a control room, such that an operator is not required to be in close proximity to the patient.

[0020] The intravascular device 102, PIM 104, and monitor 108 may be communicatively coupled directly or indirectly to the processing system 106. These elements may be communicatively coupled to the medical processing system 106 via wired connections, such as standard copper or fiber optic links, and / or via wireless connections using the IEEE 802.11 Wi-Fi standard, Ultra Wideband (UWB) standard, Wireless FireWire, Wireless USB, or another high-speed wireless networking standard. The processing system 106 may be communicatively coupled to one or more data networks, for example, a TCP / IP-based local area network (LAN). In other embodiments, a different protocol, such as Synchronous Optical Network (SONET), may be utilized. In some cases, the processing system 106 may be communicatively coupled to a wide area network (WAN). The processing system 106 may utilize network connectivity to access various resources. For example, the processing system 106 may communicate with a Digital Imaging and Communications in Medicine (DICOM) system, a Picture Archiving and Communications System (PACS), and / or a hospital information system via a network connection.

[0021] At a high level, the intravascular device 102 emits ultrasonic energy from a transducer array 124 included in a scanner assembly 110 mounted near the distal end of the intravascular device 102. The ultrasonic energy is reflected by tissue structures (e.g., lumen 120) in the medium surrounding the scanner assembly 110, and ultrasonic echo signals are received by the transducer array 124. The scanner assembly 110 generates electrical signals representing the ultrasonic echoes. The scanner assembly 110 may include one or more single ultrasonic transducers and / or transducer arrays 124 in any suitable configuration, such as a planar array, a curved array, a circumferential array, an annular array, etc. For example, the scanner assembly 110 may be a one-dimensional array or a two-dimensional array in some cases. In some examples, the scanner assembly 110 may be a rotational ultrasound device. The active area of the scanner assembly 110 may include one or more segments (e.g., one or more rows, one or more columns, and / or one or more orientations) of one or more transducer materials and / or ultrasonic elements that may be uniformly or independently controlled and activated. The active area of the scanner assembly 110 can be patterned or structured into a variety of basic or complex geometric shapes. The scanner assembly 110 can be positioned in a side-looking orientation (e.g., ultrasound energy emitted perpendicular and / or orthogonal to the longitudinal axis of the intravascular device 102) and / or a forward-looking orientation (e.g., ultrasound energy emitted along and / or parallel to the longitudinal axis). In some examples, the scanner assembly 110 is structurally configured to emit and / or receive ultrasound energy in a proximal or distal direction and at an oblique angle relative to the longitudinal axis. In some embodiments, ultrasound energy emission can be electronically steered by selective triggering of one or more transducer elements of the scanner assembly 110.

[0022] The ultrasonic transducers of the scanner assembly 110 can be piezoelectric micromachined ultrasonic transducers (PMUT), capacitive micromachined ultrasonic transducers (CMUT), single crystal, lead zirconate titanate (PZT), PZT composites, other suitable transducer types, and / or combinations thereof. In one embodiment, the ultrasonic transducer array 124 can include any suitable number of individual transducers between 1 and 1000 transducers, including 2 transducers, 4 transducers, 36 transducers, 64 transducers, 128 transducers, 500 transducers, 812 transducers, and / or other values, both greater and less.

[0023] The PIM 104 forwards the received echo signals to a processing system 106, where an ultrasound image (including flow information) is reconstructed and displayed on a monitor 108. The console or processing system 106 may include a processor and memory. The processing system 106 may be operable to facilitate the features of the intravascular imaging system 100 described herein. For example, the processor may execute computer-readable instructions stored on a non-transitory, tangible, computer-readable medium.

[0024] The PIM 104 facilitates the communication of signals between the processing system 106 and the scanner assembly 110 included in the intravascular device 102. This communication may include providing commands to the integrated circuit controller chip(s) within the intravascular device 102, selecting particular element(s) on the transducer array 124 to use for transmission and reception, providing transmit trigger signals to the integrated circuit controller chip(s) to activate transmitter circuitry to generate electrical pulses to excite the selected transducer array element(s), and / or receiving 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 104 performs pre-processing of the echo data before relaying the data to the processing system 106. In an example of such an embodiment, the PIM 104 performs data amplification, filtering, and / or aggregation. In an embodiment, the PIM 104 also provides high-voltage and low-voltage DC power to support operation of the intravascular device 102, including the circuitry within the scanner assembly 110.

[0025] The processing system 106 receives echo data from the scanner assembly 110 via the PIM 104 and processes the data to reconstruct an image of tissue structures within the medium surrounding the scanner assembly 110. In general, the device 102 can be utilized within any suitable anatomical structure and / or body cavity of a patient. The processing system 106 outputs image data such that an image of the blood vessel or lumen 120, such as a cross-sectional IVUS image of the lumen 120, is displayed on the monitor 108. The lumen 120 may represent both natural and artificial fluid-filled or surrounded structures. The lumen 120 may be within the patient's body. The lumen 120 may be a blood vessel, such as an artery or vein, of the patient's vascular system, including the cardiovascular system, peripheral vascular system, neurovascular system, renal vascular system, and / or any other suitable lumen within the body. For example, device 102 may be used to examine any number of anatomical locations and tissue types, including, but not limited to, organs including the liver, heart, kidneys, gallbladder, pancreas, lungs, ducts, intestines, brain, dural sac, nervous system structures including the spinal cord and peripheral nerves, urinary tract, and valves, ventricles, or other parts of the heart, and / or other systems of the body. In addition to natural structures, device 102 may be used to examine artificial structures, such as, but not limited to, heart valves, stents, shunts, filters, and other devices.

[0026] The processing system or controller 106 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 106 may be configured to perform one or more aspects of the present disclosure. In some embodiments, the processing system 106 and the monitor 108 are separate components. In other embodiments, the processing system 106 and the monitor 108 are integrated into a single component. For example, the system 100 may include a touchscreen device including a housing having a touchscreen display and a processor. The system 100 may include any suitable input device, such as a touch-sensitive pad or touchscreen display, a keyboard / mouse, a joystick, buttons, etc., for a user to select options shown on the monitor 108. The processing system 106, the monitor 108, the input device, and / or a combination thereof may be referred to as a controller of the system 100. The controller may communicate with the device 102, the PIM 104, the processing system 106, the monitor 108, the input device, and / or other components of the system 100.

[0027] In some embodiments, the intravascular device 102 includes several features similar to conventional solid-phase IVUS catheters, such as the EagleEye® catheter available from Volcano, Inc. and those disclosed in U.S. Patent No. 7,846,101, which is incorporated herein by reference in its entirety. For example, the intravascular device 102 may include a scanner assembly 110 near the distal end of the intravascular device 102 and a transmission wire bundle 112 extending along the longitudinal body of the intravascular device 102. The cable or transmission wire bundle 112 may include multiple conductors, including one, two, three, four, five, six, seven, or more conductors.

[0028] Transmission line bundle 112 terminates at a PIM connector 114 at the proximal end of intravascular device 102. PIM connector 114 electrically couples transmission line bundle 112 to PIM 104 and physically couples intravascular device 102 to PIM 104. In one embodiment, intravascular device 102 further includes a guidewire exit port 116. Thus, in some examples, intravascular device 102 is a rapid-exchange catheter. Guidewire exit port 116 allows a guidewire 118 to be inserted toward the distal end to guide intravascular device 102 through lumen 120.

[0029] The monitor 108 may be a display device such as a computer monitor or other type of screen. The monitor 108 may be used to display selectable prompts, instructions, and visualizations of imaging data to the user. In some embodiments, the monitor 108 may be used to provide the user with a procedure-specific workflow for completing an intravascular imaging procedure. This workflow may include performing pre-stent planning to determine the condition of the lumen and the feasibility of a stent, as well as checking the stent once it has been placed within the lumen. The workflow may be presented to the user as any of the displays or visualizations shown in FIGS. 2-9.

[0030] FIG. 2 illustrates an exemplary display 200 showing a prompt 202 in accordance with aspects of the present disclosure. In some embodiments, display 200 is displayed on monitor 108, as shown in FIG. 1 . In other embodiments, display 200 is displayed on a screen of another device, such as PIM 104. Display 200 may be generated by a controller of intravascular imaging system 100. In some embodiments, display 200 is configured to display prompts and instructions, as well as other data, to an operator. Display 200 may be used to illustrate a complete end-to-end workflow for an intravascular procedure. This workflow may include numerous prompts and instructions that may guide the operator through the procedure. This may simplify the steps of the procedure and help avoid operator error.

[0031] The prompts and instructions may be displayed on the display 200 as selectable options so that the operator can interact with the display 200 to select an option. The operator's selection may change the display 200 so that information corresponding to the selected option is shown. In the example of FIG. 1 , a selectable prompt 202 is displayed on the display 200. The prompt includes two selectable options: option 204 corresponds to pre-stent planning and option 206 corresponds to post-stent check. The operator may select one of the options 204, 206, which may move forward in the workflow so that another screen (such as prompt 302 as shown in FIG. 3) is displayed. The options 204, 206 may include a visual representation of the type of procedure. For example, option 204 may include a depiction of the vasculature within the heart, and option 206 may include a depiction of a stent. In some embodiments, selecting an option 204, 206 may include a change in the visual representation of the option 204, 206. For example, if the pre-stent planning option 204 is selected, the option 204 may appear as a shaded or gray color in future views of the display 200. This may help indicate that the option 204 was previously selected by the operator. Other types of feedback may be used to indicate the selection of an option. For example, the selectable options 204, 206 may display flashing areas, highlighted areas, changed colors, shading, altered transparency, and other visual indicators.

[0032] Option 204 may provide a workflow for pre-stent planning, which may include performing an intravascular procedure (such as a pullback operation) and viewing the results. Option 204 may be used to identify areas within lumen 120 that could benefit from the placement of a stent. Option 206 may provide a workflow for post-stent check, which may include performing an intravascular procedure (such as a pullback operation) and viewing the results in areas within lumen 120 where a stent was previously placed. Option 206 may be used to monitor the placement and effectiveness of the stent.

[0033] FIG. 3 illustrates an exemplary display 200 showing a prompt 302 according to aspects of the present disclosure. The color, shading, texture, and other graphical characteristics of the display 200 may be selected to emphasize particular features. In some embodiments, the prompt 302 may be displayed after either of options 204 or 206 is selected. In other embodiments, the prompt 302 is displayed only after the pre-stent planning option 204 is selected. The prompt 302 may prompt the operator to select a target vessel. In the example of FIG. 3 , selecting the target vessel involves selecting a region on the visualization 304 that includes an artery within the heart. Selectable regions may include the right coronary artery (RCA), the left anterior descending artery (LAD), and the left circumflex artery (LCX). Selectable regions may also include various regions of the artery, as well as other vessels and lumens within other portions of the patient's anatomy. The appearance of the visualization 304 may change when one of the regions is selected by the operator. For example, the selected artery may be outlined, highlighted, or colored a different color. In some embodiments, the selected artery is outlined in a contrasting color (e.g., blue, red, or another color), shaded, textured, or otherwise highlighted.

[0034] FIG. 4 illustrates an exemplary display 200 showing a prompt 402 according to an aspect of the present disclosure. The prompt 402 may be displayed after the operator makes a selection in response to the prompt 302 shown in FIG. 3. In the example of FIG. 4, the LAD artery has been selected by the operator. The prompt 402 shows an outlined image of the LAD along with instructions 403 for performing a pullback procedure from the most distal point on the LAD to the ostium. These instructions 403 may refer to a pullback procedure or other movement of the device 102 within the selected vessel or lumen 120. The instructions 403 may instruct the operator to perform any type of movement of the device 102 within the selected target vessel. For example, the instructions 403 may instruct the operator to push the device 102 a given distance along the selected target vessel. A visualization 404 corresponding to the instructions 403 may also be displayed on the display 200. In the example of FIG. 4, the visualization 404 includes a line 406 with an arrow indicating the direction in which the pullback procedure should be performed. The visualization 404 may include visual effects such as color changes or animation. For example, an arrow in the visualization 404 may move in a direction specified by the instructions 403. The instructions 403 and the visualization 404 may change depending on previously selected options. For example, if the operator selects the RCA as the target vessel, the visualization 404 of the RCA is highlighted and a corresponding visualization is displayed showing the procedure outlined by the instructions 403.

[0035] In some embodiments, the instructions 403 of the display 200 may change depending on which option 204, 206 is selected from the prompt 202 shown in Figure 2. For example, if the post-stent check option 206 is selected, the instructions may indicate, "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 through the imaging procedure and acquire imaging data related to the selected target vessel and / or stent.

[0036] FIG. 5 illustrates an exemplary display 200 showing a prompt 502 according to aspects of the present disclosure. The prompt 502 may be displayed after the operator makes a selection in response to the prompt 402 shown in FIG. 4. In the example of FIG. 5, the LAD artery has been selected by the operator. The prompt 502 may be accompanied by a visualization 504. In some embodiments, the visualization 504 shows imaging data from the device 102 as it is moved through the selected target vessel. The imaging data may be used as a reference for the operator. Specifically, the imaging data shown in the visualization 504 may help the operator know where to begin the procedure. In the example of FIG. 5, the imaging data may indicate when the device 102 is positioned at the distal end of the LAD artery so that a pullback operation may be performed. The imaging data may also indicate other reference data, such as regions of interest along the lumen 120, branches of the lumen 120, problem areas within the lumen 120, or other features. In some embodiments, when the device 102 is placed at a location specified by the command (e.g., a distal portion of an artery), the operator may begin recording the procedure by selecting a record button 508. The display may also include an option 506 to save specific frames of imaging data before or during the procedure.

[0037] FIG. 6 illustrates an exemplary visualization 310 according to aspects of the present disclosure. The visualization 310 may be displayed on the monitor 108. The visualization 310 may present imaging data acquired by the device 102 during an intravascular procedure. In some embodiments, the intravascular procedure is outlined in the instructions shown in FIGS. 3-5. In some embodiments, the visualization 310 includes imaging data corresponding to a lumen 120, such as a selected target vessel. The visualization 310 may include a first view 604 and a second view 610 of the lumen 120. In some embodiments, the first and second views 604, 610 may be oriented 90 degrees apart. In the example of FIG. 6, the first view 604 shows imaging data corresponding to a straight down view of the lumen 120 (discussed separately as a “longitudinal view”), and the second view 610 shows imaging data corresponding to a lateral view of the lumen 120. In other embodiments, other views may be shown. For example, Figures 7A-7C show three different views, including a third view 704 that shows a three-dimensional cross-sectional view of lumen 120. Views 604, 610 may include corresponding imaging data.

[0038] In some embodiments, visualization 310 may include a selected frame of imaging data received by device 102. For example, text box 611 indicates that visualization 310 corresponds to frame 1556 in the example of FIG. 6. The operator may be able to select any frame from the imaging data received by device 102. This may allow the operator to focus on a particular region of interest within lumen 120.

[0039] In some embodiments, measurements are automatically performed on the imaging data using the controller of intravascular imaging system 100 as the imaging data is acquired by device 102. In the example of FIG. 6 , measurements corresponding to vessel boundary 608 and minimum lumen area (MLA) 606 are displayed on first view 604. The measurements may also include vessel diameter, vessel center, thickness of vessel boundary 608, and other measurements automatically performed by the controller. These measurements may also be shown on other views. For example, marker 614 is placed at the MLA in second view 610 that corresponds to MLA 606 in first view 604. This may help the operator visualize the diameter of the vessel boundary along lumen 120. The measurements may be displayed in numeric format in box 612 on visualization 310.

[0040] Specific portions and views of visualization 300 may be viewed by the operator by selecting options 620, 622, and 624. In some embodiments, option 620 corresponds to visualization 310 shown in FIG. 6, option 622 corresponds to visualization 320 shown in FIG. 8, and option 624 corresponds to visualization 330 shown in FIG. 9. The operator may select option 620 to view a longitudinal view of lumen 120, option 622 to view a view of a lesion within lumen 120, and option 624 to view the stent and a peripheral portion of lumen 120. In some embodiments, the primary or first view 604 of each option 620, 622, 624 is accompanied by a transverse view 610 of lumen 120 as shown in FIGS. 6, 8, and 9.

[0041] 7A-7C illustrate an exemplary display 700 with various views showing imaging data according to aspects of the present disclosure. Display 700 may be displayed on monitor 108. FIG. 7A illustrates display 700 with three different views 702, 704, and 706 of imaging data. In some embodiments, view 702 is a longitudinal view of lumen 120, view 704 is a three-dimensional cross-section of lumen 120, and view 706 is a transverse view of lumen 120. View 702 may include visualization of boundaries 710, 712, 714, and 716 of aspects of the lumen. For example, boundary 710 may represent a vascular boundary, boundary 712 may represent an MLA of a portion of lumen 120, boundary 714 may represent a central region of lumen 120, and boundary 716 may represent a three-dimensional vascular boundary. Additionally, planes 718 and 719 may represent the plane along which view 702 is viewed. Boundaries 710, 712, 714, 716 in one view may correspond to boundaries 710, 712, 714, 716 in other views 702, 704, 706 of display 700. Presenting different views may help the operator visualize the size and shape of portions of lumen 120.

[0042] FIG. 7B shows an example display 700 with functionality that allows an operator to edit one or more of the visualizations of boundaries 710, 712, 714, and 716. In the example of FIG. 7B, the operator may use tool 720 to select a boundary to move (in this case, boundary 710). The selected boundary may appear as a dotted line. The boundary may be moved in any direction. In the example of FIG. 7B, arrow 722 indicates the direction in which the boundary will be moved (i.e., outward). The corresponding movement of the boundary is also shown in views 702 and 706, with arrow 722 indicating the direction of movement. The operator may move boundaries 710, 712, 714, and 716 to correct errors in the imaging data or to visualize the potential results of a procedure (such as inserting a stent into lumen 120).

[0043] 7C shows the exemplary display 700 after boundary 710 has been moved to a new location for boundary 730. As mentioned above, views 702, 704, 706 show corresponding boundaries 730, 734 that the operator can view together to better understand the shape of a portion of lumen 120.

[0044] FIG. 8 illustrates an exemplary visualization 320 showing a lesion view according to aspects of the present disclosure. In some embodiments, visualization 320 corresponds to pre-stent planning option 204 as shown in FIG. 2 . In some embodiments, visualization 320 may be used to recommend the placement and size of a stent to address the lesion. These recommendations may be made automatically by system 100 based on imaging data received by device 102. In particular, visualization 320 may be used to visualize a portion of lumen 120 having a potential “landing zone” 834 for a stent. In some embodiments, landing zone 834 is a region of interest within lumen 120 that includes the MLA of a portion of lumen 120, as marked by marker 614. Landing zone 834 may be shown in profile within view 610 to indicate the potential placement of a stent within landing zone 834. Distal end marker 830 and proximal end marker 832 of landing zone 834 may define the distal and proximal extents of the potential stent. The distal end marker 830 and the proximal end marker 832 may be accompanied by numerical data 820, 822 indicating the average diameter and plaque load of the lumen 120 at those locations. In some embodiments, the visualization may also be a depiction of the plaque load 852 along the lumen 120. In some embodiments, the depiction of the plaque load 852 is automatically measured based on imaging data from the device 102. The visualization 320 may also include a depiction of the lumen area 850. As shown in FIG. 8 , the markers 614 of the MLA may be placed where the plaque load is greatest and the lumen area is smallest.

[0045] In some embodiments, the visualization 320 includes a recommended stent diameter as shown in text box 812. This diameter may be based on the diameter of the lumen 102 as measured by the system 100.

[0046] 9 shows an exemplary visualization 330 illustrating a stent check view according to aspects of the present disclosure. In some embodiments, visualization 330 is shown after the operator selects stent check option 204 and is guided through subsequent workflow steps. Visualization 330 may display imaging data collected from device 102 during movement within lumen 120 (such as a pullback procedure) in which the stent was deployed, as well as imaging data of the surrounding area of the lumen.

[0047] Measurements and / or metrics corresponding to the imaging data may be automatically performed by the intravascular imaging system and displayed by visualization 330. For example, intravascular imaging system 100 may be used to perform length measurements, such as minimum, maximum, representative, and average lengths of features within the imaging data. The effective diameter of features may also be measured. Area measurements of features such as lumen, vessel, plaque, and thrombus may be performed by intravascular imaging system 100. Measurements may include plaque burden, stenosis ratio, percent difference, diameter stenosis, percent diameter stenosis, lumen gain, and lumen gain percent. Additionally, stent characteristics may also be measured by intravascular imaging system 100, including overall stent area, minimum stent area, average stent area, stent apposition, expansion, malapposition, and stent score. The visualization 330 may include numerical values of one or more of these measurements or other graphical representations (e.g., shading, color coding, etc.), including graphical representations that are overlaid on or displayed separately / spaced apart from a tomographic, longitudinal, and / or angiographic image of the vessel.

[0048] In some embodiments, the shape and size of the lumen boundary 904 and the boundary of the stent 906 may be measured and displayed. As in FIGS. 6 and 8 , the boundary may be visualized in the first view 604 and the second view 610. The visualization 330 may also include a measurement of the length of the stent. For example, the visualization 330 may include a distal fiducial marker 930 and a representation 934 of the stent. The mean diameter and plaque burden at the distal fiducial marker may be shown in text box 916. The minimum stent area (MSA) may also be automatically measured and displayed in text box 912 along with the MSA marker 914.

[0049] In some embodiments, the visualization 330 may be used to determine the effectiveness of the stent. For example, the visualization 330 may include a measurement and depiction of any stent apposition maladjustments. The maladaptation regions 908, 936 may be shown in both the first view 604 and the second view 610 to allow the operator to better visualize the maladaptation. The maladaptation regions 908, 936 may have a different color (e.g., red) from the other imaging data to highlight this feature. In some embodiments, the maladaptation regions 908, 936 are measured automatically using imaging data collected by the device 102 during the stent pullback procedure. The visualization 330 may also include an expansion score 910. In the example of FIG. 9 , the expansion score is 80%. This may mean that the stent is mostly expanded to contact the lumen 120, but that maladaptation is present. In some embodiments, the expansion score can vary from 0% (if the stent has not yet expanded within the vessel) to 100% (if the stent is fully expanded and there is no apposition malapposition). The expansion score 910 may be determined automatically using the controller of the system 100 by comparing measurements of the interface of the stent 906 with the interface of the lumen. In some embodiments, the expansion score 910 is also based on the plaque burden and lumen area within the vessel.

[0050] Figure 10 is a flow diagram of a method 1000 for providing a user with a guided workflow for an intravascular imaging procedure. In some embodiments, the steps of method 1000 may be performed by intravascular imaging system 100 and associated components as shown in Figure 1. It is understood that the steps of method 1000 may be performed in a different order than that shown in Figure 10, additional steps may be provided before, between, and after steps, and / or some of the steps described may be substituted or removed in other embodiments.

[0051] In step 1002, method 1000 may include providing a guided workflow to the user. The guided workflow may be provided as a series of prompts, instructions, and visualizations displayed on a display device, such as monitor 108 as shown in FIG. 1. The guided workflow may help the user easily and accurately perform each step of the intravascular imaging procedure. The guided workflow may present different options based on the user's selection and may include checks of previous steps to ensure that all steps of the procedure have been performed.

[0052] In step 1004, the method may include providing selectable options for pre-stent planning or post-stent check. The selectable options may be provided on a display such as display 200 shown in FIG. 2. The selectable option for pre-stent planning may include performing an intravascular imaging procedure to visualize the vessel or lumen before inserting the stent. The selectable option for post-stent check may include performing an intravascular imaging procedure to check the stent inserted in the vessel or lumen. Each selectable option may include several subsequent steps, as discussed below.

[0053] In step 1006, method 1000 may include providing an option for selecting a target vessel. The option may be presented visually, such as by presenting various vessels on a diagram. In some embodiments, the target vessel is an artery in the heart, such as the RCA, LAD, and LCX. In other embodiments, the target vessel is another lumen in the body. This step 1006 may include providing feedback to the user, such as indicating which vessel has been selected. The feedback may include highlighting, coloring, shading, or otherwise indicating the selected vessel.

[0054] In step 1008, method 1000 may include providing a prompt to perform an action within the selected target vessel. In some embodiments, the action includes moving the intravascular device within the vessel. For example, the action may be a pull-back action. In other embodiments, the action may be pushing the intravascular device through a portion of the lumen. The prompt may be presented in text form and may include a visualization of the action.

[0055] In step 1010, method 1000 may include providing a prompt to navigate the intravascular device to a starting point within the selected target vessel and activate a sensor within the intravascular device. The prompt may be presented with text and an image indicating where the user should place the intravascular device. In some embodiments, the prompt in step 1010 depends on the option selected in step 1004. For example, if the user selected the pre-stent planning option in step 1004, the prompt in step 1010 may prompt the user to navigate the intravascular device from the distal-most point of the target vessel to the ostium. If the user selected the post-stent check option in step 1004, the prompt in step 1010 may prompt the user to navigate the intravascular device from the distal end of the stent to the proximal end of the stent.

[0056] In step 1012, method 1000 may include receiving imaging data from the intravascular device. This imaging data may help the user accurately navigate the intravascular device according to the prompts of step 1010. For example, if the prompts of step 1010 instruct the user to navigate the intravascular device from the distal end of the stent to the proximal end of the stent, the imaging data may show imaging data from the intravascular device as the intravascular device is moved to the distal end of the stent. In some embodiments, the imaging data may include IVUS data showing tissue layers inside the blood vessel. In other embodiments, the imaging data includes data from another modality, such as OCT. Thus, the imaging data may help the user accurately perform the actions outlined in the prompts.

[0057] In step 1014, method 1000 may include displaying imaging data as the intravascular device is moved during the operation, which may assist the user in accurately performing the operation.

[0058] In step 1016, method 1000 may include identifying a region of interest using the imaging data. In some embodiments, the region of interest is identified based on imaging data such as boundary measurements, lumen area, intraluminal plaque burden, etc. The region of interest may include an MLA or MSA, as shown in FIGS. 6, 8, and 9. In some embodiments, the region of interest includes a landing zone for stent placement or a stent deployed within the lumen. The region of interest may be colored, highlighted, shaded, or otherwise indicated as a region of interest on a display of the imaging data. In some embodiments, distal and proximal ends of the region of interest, as well as measurements of the size and location of the region of interest, are indicated.

[0059] In step 1018, method 1000 may include displaying vascular measurements based on the imaging data corresponding to the region of interest. In some embodiments, vascular measurements such as vessel boundary, stent boundary, MLA, MSA, lumen area, plaque burden, and other measurements are displayed on the display. These measurements may be indicated graphically (e.g., by colored lines or areas) and textually (e.g., in text boxes). The vascular measurements may also include recommendations (e.g., recommended stent size and position) and scores (e.g., stent expansion score). The vascular measurements may enable a user to quickly identify problem areas within the lumen and possible solutions.

[0060] Those skilled in the art will appreciate that the above-described devices, systems, and methods can be modified in various ways. Accordingly, those skilled in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the specific exemplary embodiments described above. In that regard, while exemplary embodiments have been shown and described, a wide range of modifications, changes, and substitutions are contemplated in the foregoing disclosure. It is understood that such variations can be made thereto without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be broadly construed in a manner consistent with the present disclosure. [Explanation of symbols]

[0061] 100: Intravascular imaging system 102: Intravascular device 104: Patient Interface Module (PIM) 106: Console or processing system 108: Display device or monitor 110: Scanner assembly 112: Transmission line bundle 114: PIM connector 116: Guidewire exit port 118: Guidewire 120:lumen 124: Transducer array 200:Display 202:Selectable prompt 204, 206: Optional 300, 304, 310, 320, 330, 404, 504: Visualization 302, 402, 502: Prompt 403: Command 406: A line with an arrow indicating the direction in which the pullback procedure should be performed 506: Option to save specific frames of imaging data 508: Record button 604: First View 606: Minimum lumen area (MLA) 608: Blood vessel border 610: Second View 611: Text box 612: Box on Visualization 310 614: Other measurements 620, 622, 624: Optional 700:Display 702, 704, 706: Views 710, 712, 714, 716, 730, 734: Boundary 718, 719: Plane 720: Tools 722: Arrow 812: Text box 820, 822: Numeric data 830: Distal end marker 832: Proximal end marker 834: Landing Zone 850: Luminal area 904: Luminal boundary 906: Stent 908, 936: Bad juxtaposition area 910: Extended Score 912, 916: Text box 914: MSA marker 930: Distal fiducial marker 934: Stent description 1000: Method

Claims

1. a processor in communication with the intravascular imaging device; In an apparatus having: receiving imaging data acquired by the intravascular imaging device while the intravascular imaging device is moved through a blood vessel of a patient having a target region for treatment; Based on the imaging data, a first numerical value of plaque burden at a first location having a distal reference; a second numerical value of plaque burden at a second location having a proximal reference; and wherein the first location and the second location are spaced apart from a third location having the target area such that the distal datum is distal to the target area and the proximal datum is proximal to the target area; displaying the display on a display device in communication with the processor for a user to plan treatment of the target area. The apparatus is configured to:

2. The device of claim 1 , wherein the indication comprises a third numerical value of plaque burden at the third location.

3. The device of claim 1 , wherein the first and second plaque burden values comprise percentages.

4. The device of claim 1 , wherein the first and second plaque burden values are separate from a percent stenosis value.

5. The indication is: a longitudinal view of the vessel; a first marker of the distal fiducial superimposed on the longitudinal view; a second marker of the proximal fiducial superimposed on the longitudinal view; and 10. The apparatus of claim 1, comprising:

6. the indication has the target area superimposed on a first area of the longitudinal view; the first region is defined between the first marker and the second marker; the first region being visually distinct from other portions of the longitudinal view; 6. The apparatus of claim 5.

7. The apparatus of claim 5 , wherein the longitudinal view comprises a plurality of bars of varying sizes.

8. 8. The device of claim 7, wherein the plurality of bars of varying sizes represent a plurality of numerical values of plaque burden along the length of the blood vessel.

9. The device of claim 5 , wherein the longitudinal view comprises a two-dimensional curve representing a plurality of lumen area values.

10. The device of claim 1 further comprising the intravascular imaging device.

11. The device of claim 1 further comprising the display device.

12. The device of claim 1 , wherein the treatment comprises a stent configured to extend across the target area and extend between the proximal and distal datums.

13. The device of claim 1 , wherein the first plaque burden value and the second plaque burden value are relatively greater than the third plaque burden value at the third location.

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