Scoring intravascular lesions and stent deployment in medical intraluminal ultrasound imaging

Abstract

To provide a system, a device, and a methods which provide medical imaging and measurement of features including a lumen of a patient.SOLUTION: An intraluminal imaging system may be configured to receive imaging data from an imaging device positioned within the lumen and identify and measure features within the imaging data, such as a lesion and stent. The measurements may be used to generate a lesion score and / or an expansion score. The lumen score, expansion score, and associated measurements may be displayed to a user to assist in further imaging procedures or treatment options for the patient.SELECTED DRAWING: None

Description

Technical Field

[0001]

[0001] This disclosure generally relates to intravascular medical ultrasound imaging, including imaging associated with a patient's body lumen using an intravascular imaging device. For example, this disclosure describes scoring the severity of a lesion or stent expansion by analyzing an intravascular image (e.g., intravascular ultrasound or IVUS image).

Background Art

[0002]

[0002] Various types of intravascular (also called intracoronary) imaging systems are used to diagnose and treat diseases. For example, intravascular ultrasound (IVUS) imaging is widely used in interventional cardiology as a diagnostic tool for visualizing blood vessels in a patient's body. This helps to evaluate diseased blood vessels, such as arteries in the human body, to determine the need for treatment, to optimize treatment, and / or to evaluate the effectiveness of treatment.

[0003]

[0003] In some cases, intravascular imaging is performed using an IVUS device that includes one or more ultrasonic transducers. The IVUS device is passed into the blood vessel and guided to the area to be imaged. The transducer emits ultrasonic energy and receives the ultrasonic echoes reflected by the blood vessel. The ultrasonic echoes are processed to generate an image of the blood vessel of interest. The image of the blood vessel of interest includes one or more lesions or occlusions within the blood vessel. A stent is placed within the blood vessel to treat these occlusions, and intravascular imaging is performed to view the placement of the stent within the blood vessel.

Summary of the Invention

Problems to be Solved by the Invention

[0004]

[0004] Medical experts need to score the severity of lesions in a vasculature based on an image of the vasculature to determine whether the lesion is severe, moderate, or mild. Typically, a medical expert must perform this determination by visually comparing an image of the vasculature to identify the lesion and then determining the severity of the lesion. This is both logistic and prone to errors in judgment because there is a possibility that a medical expert may completely miss a lesion or misjudge the severity of a lesion. A medical expert may also be required to determine the effectiveness of a stent within a lumen simply by viewing an image of the stent within the lumen. These current methods are time-consuming and may introduce errors in identifying the severity of a lesion and the performance of a stent. Thus, there are deficiencies in current intravascular image scoring systems.

Means for Solving the Problem

[0005]

[0005] A system, device, and method are provided for evaluating an occlusion within a body lumen (e.g., a lesion within a blood vessel) and for evaluating a treatment for the occlusion (e.g., a stent within a blood vessel). In particular, an intravascular image scoring system provides an automated scoring of the severity of a lesion and the expansion of a stent. The lesion score or expansion score is provided with one or more images of the vasculature on a display device. The lesion score and expansion score assist a user in rapidly and accurately evaluating the lumen and / or stent for further imaging procedures or treatments.

[0006]

[0006] Aspects of the present disclosure advantageously provide an intravascular image scoring system and analysis that overcome the limitations of existing intravascular scoring systems.

[0007]

[0007] Embodiments of the present disclosure are control devices that communicate with an intravascular imaging device disposed within a patient's body lumen, the control device receiving imaging data related to the body lumen from the intravascular imaging device, providing measurement results of anatomical features of the body lumen based on the received imaging data, identifying an area of interest within the body lumen including a lesion based on the received imaging data, and specifying a lesion score for the lesion based on the imaging data and the measurement results of the anatomical features of the body lumen, a control device configured to perform the above, and a display device that communicates with the control device, the display device being configured to display the lesion score and an image of the body lumen based on the received imaging data on one or more screens, the image of the body lumen including the area of interest, and an intravascular medical imaging system including the display device is provided.

[0008]

[0008] In some embodiments, the control device is further configured to receive radiographic image data and pressure data of the body lumen. The lesion score is further based on the received radiographic image data and pressure data. The image of the body lumen is a radiographic image based on the received radiographic image data. The lesion score is visually correlated with the lesion on the screen. The lesion score is based on one or more of the plaque load of the body lumen and the lumen area of the body lumen within the area of interest. The imaging device includes an intravascular ultrasound (IVUS) imaging device, and the lesion score is based on the measurement results received from the pressure detection guide wire and the intravascular IVUS imaging data. The display of the lesion score includes a color corresponding to the severity of the lesion.

[0009] Receiving imaging data related to a body lumen from an intraluminal imaging device disposed within the body lumen using a control device; providing measurement results of characteristics of the body lumen using the control device based on the received imaging data; identifying an area of interest within the body lumen including a lesion using the control device based on the received imaging data; specifying a lesion score for the lesion based on the imaging data and the measurement results of the characteristics of the body lumen; displaying an image of the body lumen based on the received imaging data including the area of interest on one screen of a display device in communication with the control device; and displaying the lesion score on one screen. A method for imaging a patient's body lumen is further provided.

[0010]

[0010] In some embodiments, the imaging data is radiographic image data and pressure data of the body lumen. The method includes specifying a lesion score based on the received radiographic image data and pressure data. The method includes specifying a lesion score based on the measured plaque load in the area of interest of the body lumen and the lumen area of the body lumen. The method includes specifying a lesion score based on the imaging data received from a pressure detection guidewire and an IVUS imaging device.

[0011]

[0011] A control device in communication with an intraluminal imaging device disposed within a patient's body lumen, the control device configured to receive imaging data related to a stent disposed within the body lumen from the intraluminal imaging device, provide measurement results of the stent based on the received imaging data, and specify an expansion score for the stent based on the imaging data and the measurement results of the stent; and a display device in communication with the control device, the display device configured to display the expansion score and an image of the stent on one screen based on the received imaging data. An intraluminal imaging system is further provided.

[0012]

[0012] In some embodiments, the control device is further configured to display a longitudinal image of the body lumen on one screen of the display device. The longitudinal image includes a first indicator indicating a distal reference point of the stent and a second indicator indicating a proximal reference point of the stent. The display content further includes a cross-sectional image of the body lumen and the stent. The display content further includes a highlighted area indicating a misalignment between the stent and the body lumen. The measurement result is the lumen diameter or lumen area of the stent.

[0013]

[0013] Exemplary embodiments of the present disclosure will be described with reference to the accompanying drawings.

Brief Description of the Drawings

[0014]

Figure 1

[0014] It is a schematic diagram of an intravascular imaging system according to an aspect of the present disclosure.

Figure 2

[0015] It is an exemplary diagram of display content showing a prompt according to an aspect of the present disclosure.

Figure 3

[0016] It is an exemplary diagram of display content showing another prompt according to an aspect of the present disclosure.

Figure 4

[0017] It is an exemplary diagram of display content showing another prompt and instruction according to an aspect of the present disclosure.

Figure 5

[0018] It is an exemplary diagram of display content showing imaging data and an instruction according to an aspect of the present disclosure.

Figure 6

[0019] It is an exemplary diagram of display content showing imaging data according to an aspect of the present disclosure.

Figure 7

[0020] It is an exemplary diagram of display content showing various views of imaging data according to an aspect of the present disclosure.

Figure 8

[0021] An exemplary diagram of display content showing imaging data and automatic measurement results according to an aspect of the present disclosure.

Figure 9

[0022] An exemplary diagram of another display content showing imaging data and measurement results according to an aspect of the present disclosure.

Figure 10

[0023] An exemplary diagram of display content showing imaging data and lesion scores according to an aspect of the present disclosure.

Figure 11

[0024] An exemplary diagram of display content showing a stent and an expansion score according to an aspect of the present disclosure.

Figure 12

[0025] A flowchart of a method for identifying and displaying lesion scores according to an aspect of the present disclosure.

Figure 13

[0026] A flowchart of a method for identifying and displaying expansion scores according to an aspect of the present disclosure.

DETAILED DESCRIPTION OF THE INVENTION

[0015]

[0027] For the purpose of deepening the understanding of the principles of the present disclosure, the following will refer to the embodiments depicted in the drawings and use specific expressions to explain them. However, it is understood that this is not intended to limit the scope of the present disclosure. Any alternatives and further modifications to the devices, systems, and methods described, as well as any further uses of the principles of the present disclosure that are commonly contemplated by those skilled in the art related to the present disclosure, are fully envisioned and included in the present disclosure. In particular, it is fully envisioned that the features, components, and / or steps described in relation to one embodiment may be combined with the features, components, and / or steps described in relation to other embodiments of the present disclosure. However, for the sake of brevity, many repetitive matters regarding these combinations are not individually described.

[0016]

[0028] FIG. 1 is a schematic diagram of an intravascular imaging system 100 according to an aspect of the present disclosure. The intravascular imaging system 100 can be an intravascular ultrasound (IVUS) imaging system in some embodiments. The intravascular imaging system 100 includes an intravascular device 102, a patient interface module (PIM) 104, a console or processing system 106, a monitor 108, an angiography system 130, an external ultrasound system 132, and / or a computed tomography (CT) system 134. The intravascular device 102 is sized, shaped, and / or otherwise structurally configured to be disposed within a body lumen of a patient. For example, the intravascular device 102 can be a catheter, a guide wire, a guiding catheter, a pressure wire, and / or a flow wire in various embodiments. In some situations, the system 100 may include additional elements and / or may be implemented without one or more of the elements shown in FIG. 1. For example, the system 100 omits one or both of the external ultrasound system 132 and the CT system 134. In some embodiments, the intravascular imaging system 100 is configured to provide lesion scoring and / or stent dilation. These scoring methods assist an operator in understanding the severity of a lesion or the effective dilation of a stent.

[0017]

[0029] The intravascular imaging system 100 (or intravascular imaging system) can be any type of imaging system suitable for use in a patient's lumen or vascular structure. In some embodiments, the intravascular imaging system 100 is an intravascular ultrasound (IVUS) imaging system. In other embodiments, the intravascular imaging system 100 includes 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]

[0030] It is understood that system 100 and / or device 102 may be configured to acquire any suitable intravascular imaging data. In some embodiments, device 102 may include imaging components of any suitable imaging modality, such as optical imaging, optical coherence tomography (OCT), etc. In some embodiments, device 102 may include any suitable imaging components, such as pressure sensors, flow sensors, temperature sensors, optical fibers, reflectors, mirrors, prisms, ablation elements, radio frequency (RF) electrodes, conductors, and / or combinations thereof. Generally, device 102 may include imaging elements for acquiring intravascular data related to lumen 120. Device 102 is sized, shaped (and / or configured) for insertion into a patient's vasculature or lumen 120.

[0019]

[0031] System 100 is deployed in a catheterization laboratory that includes a control room. Processing system 106 is located within the control room. Optionally, processing system 106 may be located at another location, such as within the catheterization laboratory itself. The catheterization laboratory may include a sterilization field, and depending on the procedures being performed and / or the healthcare facility, its associated control room may or may not be sterilized. 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, 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 echocardiography, fluoroscopy, and other medical imaging modalities, or combinations thereof. In some embodiments, device 102 may be controlled from a remote location, such as a control room, such that the operator is not required to be in close proximity to the patient.

[0020]

[0032] The intravascular device 102, PIM 104, monitor 108, angiography system 130, external ultrasound system 132, and CT system 134 are communicatively coupled to the processing system 106 either directly or indirectly. These elements are communicatively coupled to the medical processing system 106 via a wired connection, such as a standard copper link or fiber optic link, and / or via a wireless connection 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 is communicatively coupled to one or more data networks, such as a TCP / IP-based local area network (LAN). In other embodiments, different protocols, such as synchronous optical networking (SONET), are used. In some cases, the processing system 106 is communicatively coupled to a wide area network (WAN). The processing system 106 uses network connection capabilities to access various resources. For example, the processing system 106 communicates with a medical digital imaging and communications (DICOM) system, a picture archiving and communication system (PACS), and / or a hospital information system via a network connection.

[0021]

[0033] At a high level, the intraluminal device 102 emits ultrasonic energy from a transducer array 124 included in a scanner assembly 110 mounted near the distal end of the intraluminal device 102. The ultrasonic energy is reflected by tissue structures within a medium (e.g., lumen 120) in the vicinity of the scanner assembly 110, and an ultrasonic echo signal is received by the transducer array 124. The scanner assembly 110 generates an electrical signal representative of the ultrasonic echo. The scanner assembly 110 can include one or more, single ultrasonic transducers and / or transducer arrays 124 having any suitable configuration, such as, for example, a planar array, a curved array, a circumferential array, an annular array, etc. For example, in some cases, the scanner assembly 110 can be a one-dimensional array or a two-dimensional array. In some cases, the scanner assembly 110 can be a rotational ultrasonic device. The active area of the scanner assembly 110 can include one or more transducer members and / or one or more segments of ultrasonic 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 110 can be patterned or structured in various basic or complex shapes. The scanner assembly 110 can be in a side-looking orientation (e.g., ultrasonic energy is emitted perpendicular and / or orthogonal to the longitudinal axis of the intraluminal device 102) and / or in a forward-looking looking orientation (e.g., ultrasonic energy is emitted parallel and / or along the longitudinal axis). In some cases, the scanner assembly 110 is structurally arranged to emit and / or receive ultrasonic energy at an angle inclined with respect to the longitudinal axis in a proximal or distal direction. In some embodiments, the emission of ultrasonic energy can be electronically steered by selective triggering of one or more transducer elements of the scanner assembly 110.

[0022]

[0034] The ultrasonic transducer of the scanner assembly 110 can be a piezoelectric microfabricated ultrasonic transducer (PMUT), a capacitive microfabricated ultrasonic transducer (CMUT), a single crystal, lead zirconate titanate (PZT), a PZT composite material, 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 values such as, for example, 2 transducers, 4 transducers, 36 transducers, 64 transducers, 128 transducers, 500 transducers, 812 transducers, and / or other values greater than and less than these.

[0023]

[0035] PIM 104 transmits the received echo signal to the processing system 106, where an ultrasonic image (including flow information) is reconstructed and displayed on the monitor 108. The console or processing system 106 can include a processor and a memory. The processing system 106 is operable to facilitate the functions of the intravascular imaging system 100 described herein. For example, the processor can execute computer-readable instructions stored on a non-transitory tangible computer-readable medium.

[0024]

[0036] PIM104 facilitates signal communication between the processing system 106 and the scanner assembly 110 included in the intravascular device 102. This communication includes providing commands to the integrated circuit control device chip within the intravascular device 102, selecting specific elements in the transducer array 124 used for transmission and reception, providing a transmission trigger signal to the integrated circuit control device chip to activate a transmitter circuit to generate an electrical pulse to excite the selected transducer array elements, and / or receiving the amplified echo signals received from the selected transducer array elements via an amplifier included in the integrated circuit control device chip. In some embodiments, PIM104 performs a preliminary process of echo data before relaying the data to the processing system 106. In an example of such an embodiment, PIM104 performs amplification, filtering, and / or collection of the data. In one embodiment, PIM104 further supplies high-voltage and low-voltage DC power to support the operation of the intravascular device 102 including circuits within the scanner assembly 110.

[0025]

[0037] In some embodiments, PIM104 facilitates communication between the processing system 106 and one or more of the angiography system 130, the external ultrasound system 132, and / or the CT system 134. The angiography system 130 includes components configured to perform any of radiography, angiography, and fluoroscopy. In some situations, the angiography system 130 and / or the CT system 134 are used to acquire an image of the vasculature of a subject that is used as a reference for other imaging data. For example, an angiography image is displayed together with intravascular imaging data (e.g., as shown in FIG. 10) to provide a more appropriate context for the image.

[0026]

[0038] In some embodiments, the IVUS data and / or the external ultrasound data may be coregistered with the 2D or 3D CT images, which further improves the accuracy of placement and shortens the procedure time. The placement of the intraluminal device 102 may be verified using this multi-imaging system, which improves the results relative to standard fluoroscopy assistance. In some embodiments, the intraluminal device 102 is tracked to a target location (e.g., a lesion or aneurysm) identified in the CT image and / or angiogram. In some embodiments, a road map generated from the coregistered IVUS and CT image data is correlated with the fluoroscopy data to further improve accuracy. For example, the processing system 106 generates an imaging loop based on the road map and fluoroscopy data to improve the navigation of the intraluminal device 102 through the patient's vasculature.

[0027]

[0039] 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 the tissue structure within the medium in the vicinity of the scanner assembly 110. Generally, the device 102 can be used within any suitable anatomical structure and / or the body lumen of a patient. The processing system 106 outputs image data such that an image of the vasculature or lumen 120, such as a cross-sectional IVUS image of the lumen 120, is displayed on the monitor 108. The lumen 120 represents a natural and artificial, fluid-filled or surrounded structure. The lumen 120 is present within the patient's body. The lumen 120 can be a blood vessel, artery, or vein of the patient's vasculature, such as a cardiac vasculature structure, a peripheral vasculature structure, a neurovascular structure, a renal vasculature structure, and / or any other suitable lumen within the body. For example, the device 102 can be used to examine any number of anatomical locations and tissue types, such as, but not limited to, organs such as the liver, heart, kidney, gallbladder, pancreas, lungs; ducts; intestines; nervous system structures such as the brain, dural sac, spinal cord, and peripheral nerves; the urinary tract; and valves within the blood, heart chambers, or other parts of the heart and / or other systems of the body. In addition to natural structures, the device 102 is used to examine artificial structures such as, but not limited to, heart valves, stents, shunts, filters, and other devices.

[0028]

[0040] The control device or processing system 106 may include a processing circuit including one or more processors that communicate with a memory and / or other suitable tangible computer-readable storage media. The control device or processing system 106 is configured to execute 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 one component. For example, the system 100 may include a touch screen device including a housing including a touch screen display and a processor. The system 100 may include any suitable input device for a user to select options presented on the monitor 108, such as a touch-sensitive pad, or a touch screen display, keyboard / mouse, joystick, buttons, etc. The processing system 106, the monitor 108, the input device, and / or combinations thereof may be referred to as the control device of the system 100. The control device 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.

[0029]

[0041] In some embodiments, the processing system 106 is configured to calculate a lumen score and / or an expansion score for a stent based on imaging data received from the device 102, the angiography system 130, the external ultrasound system 132, and / or the CT system 134. These scorings are provided on the screen of the monitor 108 together with other imaging data, such as one or more images of the lumen. The lesion score and the expansion score correlate to severity or effectiveness based on an established rating scale. These scorings are useful to the user for accurately and quickly assessing the lesion or stent and for guiding the user to an appropriate treatment. This increases the reliability of the evaluation of the lesion and stent and reduces the time in the scoring process.

[0030]

[0042] In some embodiments, the intravascular device 102 includes some features similar to those of conventional solid-state IVUS catheters, such as, for example, the EagleEye® catheter available from Volcano Corporation, and those disclosed in U.S. Patent No. 7,846,101, which is hereby incorporated by reference in its entirety. For example, the intravascular device 102 can include a scanner assembly 110 near the distal end of the intravascular device 102 and a transmission line bundle 112 extending along the longitudinal body of the intravascular device 102. The cable or transmission line bundle 112 can include a plurality of conductors, for example, one, two, three, four, five, six, seven, or more conductors.

[0031]

[0043] The transmission line bundle 112 terminates at a PIM connector 114 at the proximal end of the intravascular device 102. The PIM connector 114 electrically couples the transmission line bundle 112 to the PIM 104 and physically couples the intravascular device 102 to the PIM 104. In one embodiment, the intravascular device 102 further includes a guide wire exit port 116. Thus, in some cases, the intravascular device 102 is a rapid exchange catheter. The guide wire exit port 116 allows a guide wire 118 to be inserted distally therethrough to direct the intravascular device 102 through the lumen 120.

[0032]

[0044] The monitor 108 is a display device, such as, for example, a computer monitor or other type of screen. The monitor 108 is used to display selectable prompts, instructions, and visualization results of imaging data to the user. In some embodiments, the monitor 108 is used to provide the user with a process-specific workflow for performing an intravascular imaging process. This workflow includes performing a pre-stent plan to identify the condition of the lumen and the potential for stents, and checking the stents placed within the lumen. The workflow is presented to the user as any of the display contents or visualization results shown in FIGS. 2-7.

[0033]

[0045] Figure 2 shows an exemplary display content 200 showing the prompt 202 according to an aspect of the present disclosure. In some embodiments, the display content 200 is displayed on the monitor 108 shown in FIG. 1. In other embodiments, the display content 200 is displayed on the screen of another device, such as the PIM 104. The display content 200 is generated by a control device of the intravascular imaging system 100. In some embodiments, the display content 200 is configured to display prompts, instructions, and other data to the operator. The display content 200 is used to show a complete overall workflow for the intravascular procedure. This workflow includes many prompts and instructions that guide the operator through the procedure. This helps to simplify the steps of the procedure and avoid operator errors.

[0034]

[0046] Prompts and instructions are presented in the display content 200 as selectable options so that an operator can interact with the display content 200 to select an option. The operator's selection changes the display content 200 so that information corresponding to the selected option is shown. In the example of FIG. 2, selectable prompt 202 is presented in the display content 200. The prompt includes two selectable options, namely option 204 corresponding to a pre-stent plan and option 206 corresponding to a post-stent check. The operator selects one of the options 204, 206, and that selection advances the workflow, resulting in the display of another screen (e.g., prompt 302 shown in FIG. 3). Options 204, 206 include a visual representation of the type of procedure. For example, option 204 includes a depiction of the vasculature within the heart and option 206 includes a depiction of a stent. In some embodiments, the selection of options 204, 206 is accompanied by a change in the visual depiction of options 204, 206. For example, if pre-stent plan option 204 is selected, option 204 is shaded or appears gray in future displays of the display content 200. This helps to indicate that this option 204 has been previously selected by the operator. Other types of feedback may be used to indicate the selection of an option. For example, selectable options 204, 206 display a blinking area, a highlighted area, a changed color, a shadow, a changed transparency, and other visual indicators.

[0035]

[0047] Option 204 provides a workflow for a pre-stent plan that involves performing an intraluminal procedure (e.g., a pullback operation) and viewing the results. Option 204 is used to identify an area within the lumen 120 that will benefit from the placement of a stent. Option 206 provides a workflow for a post-stent check that involves performing an intraluminal procedure (e.g., a pullback operation) and viewing the results of the area within the lumen 120 where the stent was previously placed. This option 206 is used to observe the placement and effectiveness of the stent.

[0036]

[0048] Figure 3 shows an exemplary display content 200 showing a prompt 302 according to an aspect of the present disclosure. In some embodiments, the prompt 302 is displayed after either of the options 204, 206 is selected. In other embodiments, the prompt 302 is displayed only after the pre-stent plan option 204 is selected. The prompt 302 prompts the operator to select a target vasculature. In the example of Figure 3, selecting the target vasculature involves selecting an area in the visualization result 304 that includes arteries within the heart. The selectable areas may include the right coronary artery (RCA), the left anterior descending branch (LAD), and the left circumflex branch (LCX). The selectable areas may include various regions of the artery and other blood vessels and lumens within other parts of the patient's anatomical structure. When one of the areas is selected by the operator, the appearance of the visualization result 304 may be changed. For example, the selected artery may be outlined, highlighted, or colored with a different color. In some embodiments, as shown in Figure 4, the selected artery is outlined in blue.

[0037]

[0049] Figure 4 shows an exemplary display content 200 showing a prompt 402 according to an aspect of the present disclosure. The prompt 402 is displayed after the operator makes a selection for the prompt 302 shown in Figure 3. In the example of Figure 4, the LAD artery is selected by the operator. The prompt 402 shows an image depicting the contour of the LAD, along with an instruction 403 for performing a retraction process from the most distal point in the LAD to the small hole. These instructions 403 represent the retraction process or other movement 102 of the device within the selected vessel or lumen 120. The instruction 403 instructs the operator to perform any kind of movement of the device 102 within the selected target vessel. For example, the instruction 403 instructs the operator to push the device 102 a given distance along the selected target vessel. A visualization result 404 corresponding to the instruction 403 is also displayed in the display content 200. In the example of Figure 4, the visualization result 404 includes a blue line 406 including an arrow indicating the direction in which the retraction process must be performed. The visualization result 404 may include changing a visual effect, such as color or animation. For example, the arrow of the visualization result 404 moves in the direction specified by the instruction 403. The instruction 403 and the visualization result 404 vary according to the previously selected option. For example, if the operator selects the RCA as the target vessel, the visualization result 404 of the RCA is highlighted, and the corresponding visualization result is displayed to show the process outlined by the instruction 403.

[0038]

[0050] In some embodiments, the instruction 403 of the display content 200 changes according to which option 204, 206 is selected from the prompt 202 shown in Figure 2. For example, if the option 206 of post-stent check is selected, the instruction displays "Please perform a retraction from the distal point of the stent to the proximal point of the stent". Other instructions may be included to guide the operator to perform an imaging process and to obtain imaging data related to the selected target vessel and / or stent.

[0039]

[0051] FIG. 5 shows an exemplary display content 200 showing a prompt 502 according to an aspect of the present disclosure. The prompt 502 is displayed after the operator makes a selection for the prompt 402 shown in FIG. 4. In the example of FIG. 5, the LAD artery has been selected by the operator. A visualization result 504 is associated with the prompt 502. In some embodiments, the visualization result 504 shows imaging data from the device 102 as the device 102 is moved through the selected target vasculature. The imaging data is used as a reference for the operator. In particular, the imaging data shown in the visualization result 504 helps the operator know where to start the procedure. In the example of FIG. 5, the imaging data shows when the device 102 is positioned at the distal end of the LAD artery such that a retraction operation is performed. The imaging data may also show other reference data, such as areas of interest along the lumen 120, branches of the lumen 120, problem areas within the lumen 120, and other features. In some embodiments, when the device 102 is positioned at the designated position (e.g., at the distal portion of the artery) according to the instructions, the operator may select a record button 508 to start recording the procedure. The display content further includes an option 506 for saving a particular frame of the imaging data before or during the procedure.

[0040]

[0052] Figure 6 shows an exemplary visualization result 310 according to an aspect of the present disclosure. The visualization result 310 is displayed on the monitor 108. The visualization result 310 presents 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 result 310 includes imaging data corresponding to the lumen 120, such as a selected target vasculature. The visualization result 310 may include a first view 604 and a second view 610 of the lumen 120. In some embodiments, the first view 604 and the second view 610 are oriented 90 degrees offset. In the example of FIG. 6, the first view 604 shows imaging data corresponding to a view of the lumen 120 straight on (or described as the "longitudinal view"), and the second view 610 shows imaging data corresponding to a cross-sectional view of the lumen 120. The views 604, 610 include the corresponding imaging data. The display content of the first view 604 and the second view 610 is not shown in existing systems that generally include one tomographic image. In other embodiments, other views may be shown, including one or more cross-sectional, sectional, tomographic, 3D, or 4D images. For example, a 4D cross-sectional image is a 3D cross-sectional image with a time component shown.

[0041]

[0053] In some embodiments, the visualization result 310 includes selected frames of the imaging data received by the device 102. The operator may be able to select any frame from the imaging data received by the device 102. This enables the operator to focus on a particular area of interest in the lumen 120.

[0042]

[0054] In some embodiments, when imaging data is acquired by device 102, measurements are automatically performed on the imaging data using the control device of the intravascular imaging system 100. Existing imaging systems typically require an operator to manually select frames of interest and mark areas for measurement. This is a time-consuming process and can induce user errors, particularly in marking areas for measurement. These errors can result in the operator missing important features in the imaging data, such as lesions. The intravascular imaging system 100 provides automatic measurement of features in the received imaging data without the need for user interaction. In some embodiments, the system 100 automatically measures all applicable boundaries in the imaging data (including those in the displayed image), such as anatomical boundaries (e.g., lumen boundaries), and stents. Further, the system 100 automatically identifies areas of interest based on the automatic measurements and displays these areas of interest correlated with the longitudinal view or angiographic image of the lumen. This automatic measurement, analysis, and display provide an easy-to-understand overview of the patient's lumen and provide data for generating a lesion score.

[0043]

[0055] In the example of FIG. 6, the automatic measurement results corresponding to the vessel boundary 608 and the minimum lumen area (MLA) 606 are displayed in the first view 604. The measurement results may include the diameter of the blood vessel, the center of the vessel, the thickness of the vessel boundary 608, and other measurement results automatically performed by the control device. These measurement results may be shown in other views. For example, marker 614 is located at the MLA in the second view 610 corresponding to the MLA 606 in the first view 604. This helps the operator visualize the diameter of the vessel boundary along the lumen 120. The measurement results are displayed in numerical form in box 612 in the visualization result 310. Specific portions and views of the visualization result 300 are viewed by the operator by selecting options 620, 622, and 624.

[0044]

[0056] Figure 7 shows an exemplary visualization result 700 showing a lesion view according to an aspect of the present disclosure. In some embodiments, the visualization result 700 corresponds to the pre-stent plan option 204 shown in FIG. 2. In some embodiments, the visualization result 700 is used to recommend stent placement and size to address the lesion. These recommendations are automatically generated by the system 100 based on the imaging data received by the device 102. In particular, the visualization result 700 may be used to visualize a portion of the lumen 120 along with a possible "landing zone" 834 for the stent. In some embodiments, the landing zone 834 is an area of interest within the lumen 120 that includes the MLA of the portion of the lumen 120 marked by the marker 614. The landing zone 834 is shown in the profile in the view 610 to indicate possible stent placement within the landing zone 834. The distal marker 830 and proximal marker 832 of the landing zone 834 define the distal and proximal extents of the possible stent. The distal marker 830 and proximal marker 832 are accompanied by numerical data 820, 822 indicating the average diameter and plaque load of the lumen 120 at these positions. In some embodiments, the visualization result is also 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 the imaging data from the device 102. The visualization result 700 further includes a depiction of the lumen area 850. As shown in FIG. 7, the marker 614 for the MLA is located where the plaque load is maximum and the lumen area is minimum. One or more of the plaque load measurement results, lumen diameter measurement results, lumen area measurement results, and other image-based or physiological function-based measurement results are used to generate a lesion score.

[0045]

[0057] In some embodiments, the visualization result 700 includes a recommended stent diameter shown in the text box 812. This diameter is based on the diameter of the lumen 102 measured by the system 100.

[0046]

[0058] FIG. 8 shows an exemplary visualization result 800 according to an aspect of the present disclosure. The visualization result 800 is displayed on the monitor 108. The visualization result 800 includes an image 902 of the lumen 910 and the surrounding tissue. The image 902 is a radiation image, for example, an angiogram image. In some embodiments, the lumen 910 includes a highlighted region 904. In some embodiments, the system 100 automatically measures features of the lumen including lumen diameter and / or area, and labels the features of the lumen. The highlighted region 904 includes one or more regions of interest 906 based on these measurement results. In the example of FIG. 9, the highlighted region 904 includes three regions of interest 906 labeled by A, B, and C. In some embodiments, the highlighted region 904 is colored according to the percent stenosis. A color scale key 908 is displayed on the angiogram image, showing the correlation between the coloring in the highlighted region and the percent stenosis. In the example of FIG. 8, the red coloring across the region of interest 906 indicates a potentially serious lesion. The imaging data within the image 902 of FIG. 8 is used to generate a lesion score. For example, the system 100 analyzes the color data within the highlighted region 904 and identifies the presence of a potentially serious lesion in the region of interest 906.

[0047]

[0059] FIG. 9 shows an exemplary visualization result 900 according to an aspect of the present disclosure. The visualization result 900 is displayed on the monitor 108. The visualization result 800 includes an image 912 of a lumen 920 and surrounding tissue, which is a radiation image, for example, an angiographic image. The lumen 910 includes measurement results automatically performed by the system 100. These measurement results include the plaque load displayed by symbols 922 along the length of the lumen 910. In some embodiments, the symbol 922 appears as a dot representing the severity of the plaque load in the lumen. Each dot corresponds to a plaque load of 10%, 15%, or 20%. In the example of FIG. 9, the plaque load in the region of interest 932 is approximately 80%, indicating a very serious lesion. The lumen further includes one or more regions of interest 932 automatically identified by the system 100 based on the measurement results of the features in the lumen. In some embodiments, text boxes 924, 924, 926 are displayed for each region of interest 932 in the image 912. These text boxes 924, 926, 928 include the longitudinal measurement results (e.g., 8, 9, or 12 mm) of the region of interest 932 shown together with the arrow symbol 930 in the image 912. The text boxes 924, 926, 928 further include the change in diameter across the lumen 910 for each region of interest 932 (e.g., 0.08, 0.04, and 0.16 mm).

[0048]

[0060] Figure 10 shows an exemplary visualization result 1000 including a lesion score 1002 according to an aspect of the present disclosure. The visualization result includes an angiography image 1012 that is an image including a lumen 920, and one or more intraluminal views 1010, 1020, 1030 of the lumen 920. In some embodiments, the intraluminal views 1010, 1020, 1030 are cross-sectional views of the lumen 920 showing different positions along the lumen 920. For example, the lumen includes a region of interest 932 identified by the system 100 based on measured parameters of the lumen 920. The first intraluminal view 1010 correlates with a distal reference position in relation to the region of interest 932, the second intraluminal view 1020 correlates with the minimum lumen area (MLA) of the region of interest 932, and the third intraluminal view 1030 correlates with a proximal reference position in relation to the region of interest 932. The intraluminal views 1010, 1020, 1030 are generated by the system 100 after receiving imaging data from an intraluminal device 102 that is moved through the lumen. In some embodiments, the intraluminal views 1010, 1020, 1030 are visually correlated with their positions along the angiography view of the lumen 920, for example, by the dotted lines 1013 shown and a matching color. Other visual correlations, such as common symbols or indicators, are possible. The intraluminal views 1010, 1020, 1030 provide a more complete view of the lumen 920 to give the user a more complete view of the lumen 920 and the surrounding tissue.

[0049]

[0061] In some embodiments, the lesion score 1002 is provided in the visualization result 1000. The lesion score is displayed in the image 1012, for example, proximate to the region of interest 932. The lesion score 1002 provides an indication of the severity of the lesion. Although scoring of the lesion and stent dilation is discussed, the scoring methods presented herein may be extended to other uses in vascular diagnosis, such as scoring the severity of aneurysms, thrombi, or other vascular diseases, and the associated treatment scores. The lesion score 1002 is calculated using one or more factors such as plaque burden, lumen area, lumen diameter, percent stenosis, eccentricity of the lumen, calcified sites within the lumen, location along the lumen (e.g., near a bifurcation), and / or pressure measurement results within the lumen (e.g., FFR, IFR, PDPA). In some embodiments, the lesion score 1002 further includes factors related to angiographic images. For example, the ratio of the minimum width of the region of interest 932 in the lumen 920 to the reference length of the region of interest (i.e., the distance between the distal reference point and the proximal reference point), the ratio of the occlusion or lesion compared to other parts of the lumen 920, tortuosity in the lumen 920, and / or image quality issues, such as a hazy area. These factors are weighted such that factors that are more likely to be accurate are weighted higher than factors that are less likely to be accurate. In some embodiments, factors related to invasive procedures (e.g., factors related to IVUS data or other intravascular data) are weighted higher than factors related to non-invasive procedures. The lesion score 1002 is displayed together with a highlighted area corresponding to the region of interest 932 and the maximum possible lesion score.

[0050]

[0062] In some embodiments, the lesion score is represented by a number between 0 and 100, where 0 is the least severe and 100 is the most severe. In some embodiments, a high lesion score (e.g., 90 or 95) correlates with a severe lesion, and a low score (e.g., 25 or less) correlates with a mild lesion. In other embodiments, the lesion score ranges from a value of 0.0 (least severe) to a value of 1.0 (most severe). The lesion score correlates with visual cues, such as a color scheme (shown by the highlighted region 904 in FIG. 8), such that red is severe and green is not severe. Other numerical assignment systems, color schemes, and visual cues are also contemplated to represent the lesion score.

[0051]

[0063] In some embodiments, the user is able to select the lesion score 1002 and view the factors and / or weights involved in its determination. The user can also select the text box 924 and cross-sectional views 1010, 1020, 1030 to access more information. In some embodiments, the cross-sectional views 1010, 1020, 1030 include highlighted boundaries of tissue layers, such as the boundary 1016 of the vasculature and the boundary 1018 of the lumen. The image 1012, cross-sectional views 1010, 1020, 1030, and lesion score 1002 help the user to more clearly understand the layout of the lumen 920 and the surrounding tissue and the severity of the lesion within the lumen 920.

[0052]

[0064] Figure 11 shows an exemplary visualization result 1100 showing a stent within a lumen according to an aspect of the present disclosure. In some embodiments, the visualization result 1100 is shown after an operator selects option 204 of the stent check of FIG. 2 and is guided through subsequent workflow steps. The visualization result 1100 displays imaging data collected from the device 102 during movement (e.g., retraction procedure) within the lumen 120 in which the stent is disposed, and imaging data of the peripheral area of the lumen. The visualization result 1100 includes a longitudinal view 1110 of the vasculature and the stent, and a cross-sectional view 1122 of the vasculature and the stent. The system 100 automatically measures features in the imaging data, such as the lumen boundary, the vasculature boundary, and the stent edges and boundaries. For example, the shape and dimensions of the stent boundary 1124 are measured and displayed in the cross-sectional view 1122. The shape and dimensions of the stent are measured and displayed as the depiction of the stent 1115 in the longitudinal view 1110. The visualization result 1100 includes measurements of the diameter, area, and length of the stent. These measurement results are displayed within the stent scale box 1106. In the example of FIG. 11, the minimum stent area (MSA) is measured at 10.1 mm 2 and the minimum stent diameter (MSD) is measured at 3.5 mm.

[0053]

[0065] The visualization result 1100 includes indicators 1114, 1118 that mark the distal and proximal edges of the stent based on the received imaging data, and indicators 1112, 1120 mark the distal reference point and the proximal reference point. These reference points are automatically determined by the system 100 based on the percent stenosis measured within the lumen, for example, 30 percent stenosis or more. In other embodiments, the distal and proximal references are determined by the user. The indicators 1112, 1120 are moved along the lumen by the user to view different sets of imaging data. The visualization result 1100 further includes an indicator 1116 that marks the MSA of the stent. The cross-sectional view 1122 corresponds to this indicator as shown in FIG. 11. The user can also select any of the other indicators 1112, 1114, 1118, 1120 to access the cross-sectional view that includes data corresponding to the position of the selected indicator 1112, 1114, 1118, 1120 within the vasculature.

[0054]

[0066] In some embodiments, an expansion score 1102 is provided in the visualization result 1100. The expansion score may be included in the stent sizing box 1106. The expansion score 1102 is calculated using one or more factors. In some embodiments, the expansion score is based on how closely the struts 1117 of the stent 1115 are aligned with the lumen wall. In particular, the more struts 1117 that are significantly displaced from the lumen wall, the lower the expansion score. The stent struts 1117 are depicted in the visualization result, including the red-highlighted areas where the stent struts 1117 are not aligned with the lumen wall. The misalignment between the stent 1115 and the lumen is shown in the cross-sectional view 1122, for example, by the highlighted area 1126. The expansion score may be based on other factors such as the alignment of other features of the stent with the lumen wall, the expansion at the edges of the stent, the measured stent area, diameter, and length, areas of misalignment or incomplete apposition, the placement of the stent along the lumen, and / or pressure measurements within the lumen (e.g., FFR, IFR, PDPA). These factors are weighted such that factors that are more likely to be accurate are weighted higher than factors that are less likely to be accurate. In some embodiments, factors related to invasive procedures (e.g., factors related to IVUS data or other intravascular data) are weighted higher than factors related to non-invasive procedures.

[0055]

[0067] In some embodiments, the dilation score is represented by a number between 0 and 100, where 0 means no dilation at all and 100 means fully dilated. In other embodiments, the dilation score ranges from a value of 0.0 (no dilation) to a value of 1.0 (fully dilated). Similar to the lesion score, the dilation score correlates to visual cues, such as a color scheme where red represents stent misalignment (shown in FIG. 11) and black represents the fully aligned state of the stent. This color scheme varies across the image of the stent so that the user can visually see which areas of the stent are not aligned with the lumen wall. Other numerical assignment systems, color schemes, and visual cues are also envisioned to represent the dilation score.

[0056]

[0068] As shown in FIG. 11, the dilation score 1102 is displayed along with a highlighted area corresponding to the area of incomplete apposition 1126. The area of incomplete apposition is shown in both a cross-sectional view 1122 and a longitudinal view 1110 to give the user a clear view of the problem including the stent. The recommendation 1104 is displayed in the visualization result 1100 based on the dilation score 1102. In the example of FIG. 11, the recommendation is "Post-dilation is required." based on a dilation score of 84. In some embodiments, the recommendation 1104 includes post-dilation for dilation scores less than 90 percent, 85 percent, 80 percent, or 75 percent. Other recommendations 1104, such as re-imaging a particular area of the lumen, may be provided. The visualization result 1100 includes identifying the placement of the stent edges. In the example of FIG. 11, the distal edge is identified as "bad" and the proximal edge is identified as "ok". The identification of the stent edges is based on the dilation of the stent wall proximate to the stent edges. For example, the stent edge is identified as "bad" if the dilation is less than 90, 85, 80, or 75 percent. The visualization result 1100 with the dilation score 1102 helps the user to more clearly understand the placement and dilation of the stent within the lumen.

[0057]

[0069] FIG. 12 is a flow diagram of a method 1200 for presenting to a user a guided workflow for an intravascular imaging procedure. In some embodiments, the steps of method 1200 are performed by any of the intravascular imaging system 100 and related components shown in FIG. 1, and the display content shown in FIGS. 5-11. The steps of method 1200 may be performed in an order different from that shown in FIG. 12, additional steps may be provided before, during, and after the steps, and / or some of the steps described may be replaced or removed in other embodiments.

[0058]

[0070] In step 1202, method 1200 includes providing a prompt to navigate an intravascular imaging device within a lumen. The intravascular imaging device may be the intravascular imaging device 102 shown in FIG. 1. The prompt may include navigating the intravascular imaging device to a starting point within the lumen and activating a sensor in the intravascular device. This prompt is presented with text and images indicating to the user where the intravascular device should be placed.

[0059]

[0071] In step 1204, method 1200 includes receiving imaging data from the intraluminal device. This imaging data helps the user accurately navigate the intraluminal device according to the prompt of step 1202. For example, if the prompt of step 1202 instructs the user to navigate the intraluminal device from the distal end of the tube lumen to the proximal end of the lumen, the imaging data shows the imaging data from the intraluminal device as the intraluminal device is moved through the lumen. In some embodiments, the imaging data includes IVUS data showing layers of tissue within the vasculature. In other embodiments, the imaging data includes data from another modality, such as angiographic image data. This data is used to compile an angiographic image of the lumen. Thus, the imaging data helps the user accurately perform the actions outlined in the prompt.

[0060]

[0072] In step 1206, method 1200 includes providing measurements of features within the lumen. This step includes automatically or manually measuring features within two or more views using the system. In some embodiments, the system automatically identifies features based on changes in the imaging data and automatically measures the dimensions of these features. In other embodiments, the user identifies features within the views and manually measures the dimensions of these features. Features include anatomical features such as tissue boundaries, lesions, bifurcations, etc., and artificial features such as stents. In some embodiments, measurements include the diameter and area of the lumen along the length of the lumen, and the percent stenosis of the lumen along the length of the lumen. Automatic measurements are performed on intraluminal images of the lumen and radiographic images such as angiographic images of the lumen.

[0061]

[0073] In step 1208, method 1200 has identifying a region of interest in a lumen containing a lesion. The region of interest is automatically identified based on the measurement results of step 1206. For example, the region of interest is identified around the MLA. The identified region of interest is displayed on a display device, such as monitor 108 shown in FIG. 1. The region of interest correlates to a longitudinal image of the lumen or an angiographic image.

[0062]

[0074] In step 1210, method 1200 has specifying a lesion score based on the received imaging data and manual or automatic measurement results. The lesion score is based on factors such as plaque burden, lumen area, lumen diameter, percent stenosis, eccentricity of the lumen, calcified sites within the lumen, location along the lumen (e.g., near a bifurcation), and / or pressure measurement results within the lumen (e.g., FFR, IFR, PDPA). In some embodiments, the lesion score is based on measurement results received from a pressure detection guidewire and an IVUS imaging device together. The lesion score is represented by a number between 0 and 100, where 0 is the least severity and 100 is the highest severity.

[0063]

[0075] In step 1212, method 1200 has displaying an image of the lumen on a display device. In some embodiments, two or more views of the lumen are shown on the same screen of the display device. For example, a cross-sectional intraluminal view of the lumen is shown together with an angiographic view of the lumen. The cross-sectional intraluminal view of the lumen may be shown together with a longitudinal intraluminal view of the lumen. The views of the lumen are visually correlated so that a user can easily understand which part of the lumen is being displayed. Any of the views of the lumen shown in FIGS. 5 - 11 are displayed in step 1212.

[0064]

[0076] In step 1214, method 1200 includes displaying a lesion score on a display device. In some embodiments, the lesion score is displayed on the same screen as one or more images of the lumen as described in step 1212. In some embodiments, the lesion score is displayed together with an angiographic image of the lumen and a cross-luminal view of one or more lumens. The lesion score is displayed together with recommendations, such as recommended imaging procedures or treatments based on the lesion score.

[0065]

[0077] FIG. 13 is a flowchart of a method 1300 that shows a guided workflow for an intravascular imaging procedure to a user. In some embodiments, the steps of the method 1300 are performed by the intravascular imaging system 100 and related components shown in FIG. 1, and any of the display contents shown in FIGS. 5-11. It is understood that the steps of method 1300 may be performed in an order different from that shown in FIG. 13, additional steps may be provided before, during, and after the steps, and / or some of the steps described may be replaced or removed in other embodiments.

[0066]

[0078] In step 1302, method 1300 includes providing a prompt to navigate an intravascular imaging device within a lumen. The intravascular imaging device may be the intravascular imaging device 102 shown in FIG. 1. The prompt includes navigating the intravascular imaging device to a starting point within the lumen and activating a sensor in the intravascular device. This prompt is presented together with text and images indicating where the user should place the intravascular device.

[0067]

[0079] In step 1304, method 1300 includes receiving imaging data from an intraluminal device that includes a stent. This data is used to compile angiographic images of the lumen and the stent. Thus, the imaging data helps the user to accurately perform the operations outlined in the prompt.

[0068]

[0080] In step 1306, method 1300 includes providing measurement results of the stent. This step includes automatically or manually measuring the stent in two or more views using the system. In some embodiments, the system automatically identifies the stent based on changes in the imaging data and automatically measures the dimensions of the stent. In other embodiments, the user identifies the stent in the view and manually measures the dimensions of the stent. These measurement results include the length of the stent, the position of the stent within the lumen, the alignment of the stent wall and the lumen wall, and / or the area and diameter of the stent along the length of the stent. The automatic measurement is performed in the intraluminal image of the lumen and the stent, and the radiographic image, such as the angiographic image of the lumen and the stent.

[0069]

[0081] In step 1308, method 1300 includes identifying an expansion score based on the received imaging data and the manual or automatic measurement results. The expansion score is based on one or more factors such as the alignment of the stent wall with respect to the lumen wall, the expansion at the edge of the stent, the measured stent area, diameter, and length, the area of misalignment or incomplete adhesion, the placement of the stent along the lumen, and / or the pressure measurement results (e.g., FFR, IFR, PDPA) within the lumen. In some embodiments, the expansion score is represented by a number between 0 and 100, where 0 represents a serious lack of expansion and 100 represents complete expansion.

[0070]

[0082] In step 1310, method 1300 includes displaying an image of a stent on a display device. In some embodiments, the stent is displayed within a lumen. Two or more views of the lumen and the stent are shown on the same screen of the display device. For example, a cross-lumen view of the stent and the lumen is shown together with an angiographic view of the stent and the lumen. The cross-lumen view of the stent and the lumen may be shown together with a longitudinal-lumen view of the stent and the lumen. Since the views of the stent and the lumen are visually correlated, a user can easily understand which part of the lumen is being displayed. Any of the lumen views shown in FIGS. 5-11 may be displayed in step 1310.

[0071]

[0083] In step 1312, method 1300 includes displaying an expansion score on a display device. In some embodiments, the expansion score is displayed on the same screen as one or more images of the stent and the lumen as described in step 1310. In some embodiments, the expansion score is displayed together with an angiographic image of the stent and the lumen and one or more cross-lumen views of the stent and the lumen. The expansion score is displayed together with a recommendation, such as a recommended imaging procedure or treatment based on the expansion score.

[0072]

[0084] Those skilled in the art will recognize that the apparatus, systems, and methods described above can be varied in various ways. Accordingly, those skilled in the art will understand that the embodiments encompassed by this disclosure are not limited to the specific exemplary embodiments described above. In this regard, exemplary embodiments are shown and described, but various changes, modifications, and substitutions in the above disclosure are envisioned. It is understood that such variations to the above matters may be made without departing from the scope of this disclosure. Accordingly, it is appropriate that the appended claims be construed broadly in a manner consistent with this disclosure.

Claims

1. A controller in communication with an intraluminal imaging device disposed within a body lumen of a patient, the controller comprising: receiving imaging data from the intraluminal imaging device related to a stent positioned within the body lumen; providing a measurement of the stent based on the received imaging data; determining an expansion score for the stent based on the imaging data and the measurements of the stent; A control device that performs the above steps. a display device in communication with the controller, the display device configured to display on a single screen the dilation score, a longitudinal image of the body lumen based on the received imaging data, a transverse image of the body lumen including indicia indicating a misalignment between the stent and the body lumen, and imaging and treatment recommendations based on the dilation score; Equipped with An endoluminal imaging system, wherein the longitudinal image includes an indicator indicating a minimum stent area, and the transverse image includes a shape and size of the stent boundary at a location corresponding to the indicator.

2. The endoluminal imaging system of claim 1 , wherein the longitudinal image includes a first indicator indicating a distal reference point of the stent and a second indicator indicating a proximal reference point of the stent.

3. The intraluminal imaging system of claim 1 , wherein the transverse image further comprises a highlighted region indicating a misalignment between the stent and the body lumen.

4. The intraluminal imaging system of claim 1 , wherein the measurement is a luminal diameter of the stent.

5. The intraluminal imaging system of claim 1 , wherein the measurement is a luminal area of ​​the stent.

Images