System, device, and method for stent and blood vessel visualization and diagnosis

Abstract

To provide a system, a device, and a method for stent and blood vessel visualization and diagnosis.SOLUTION: A method for evaluating an intravascular stent arrangement includes: a step for generating an expression of one segment of the blood vessel using a first intravascular dataset acquired for the blood vessel with the use of one or more computing devices; a step for receiving selection of a relative first reference for the expression of the one segment of the blood vessel; a step for receiving selection of a relative second reference for the expression of the one segment of the blood vessel; a step for generating a target stent contour on the basis of the first reference and the second reference using the one or more computing devices; a step for generating a blood vessel lumen contour after the stent is arranged in the blood vessel using the one or more computing devices; and a step for comparing the target stent contour to one or more regions of the blood vessel lumen contour.SELECTED DRAWING: Figure 7

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 028,711, filed July 24, 2014, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Coronary artery disease is one of the leading causes of death worldwide. Being able to better diagnose, monitor, and treat coronary artery disease could be critical to saving lives. Intravascular optical coherence tomography (OCT) is a catheter-based imaging modality that uses light to peer inside the coronary artery walls and generate images for review. OCT utilizes coherent light, interferometry, and micro-optics to provide video-rate in vivo tomography with micrometer-level resolution within diseased vessels. OCT is particularly useful for minimally invasive imaging of internal tissues and organs, as it can use a fiber-optic probe to view subsurface structures in high resolution. This level of detail enabled by OCT allows users to diagnose and monitor the progression of coronary artery disease.

[0003] OCT imaging of parts of a patient's body provides physicians with a useful diagnostic tool. For example, imaging coronary arteries with intravascular OCT can reveal areas of narrowing. This information can help cardiologists choose between invasive coronary artery bypass surgery or less invasive catheter-based procedures such as angioplasty or stent delivery. Stent delivery, although a popular option, comes with its own inherent risks.

[0004] A stent is a tubular structure, often made of a mesh. A stent can be inserted into a blood vessel and expanded to relieve a stenosis that impedes blood flow. Stents are typically made of a metal or polymer scaffold. Stents can be deployed at the site of the stenosis by a catheter. In cardiovascular procedures, stents can be delivered to the site of the stenosis by a guidewire through a catheter and expanded using a balloon. Typically, stents are expanded at a preset pressure to expand the lumen of the stenotic blood vessel.

[0005] There are several factors that influence the outcome of a stent being deployed in a patient. In some procedures, the stent must be expanded to a diameter equivalent to that of the adjacent healthy vessel segment. Overexpansion of the stent may damage a large area of ​​the vessel, predisposing it to dissection, transection, or intramural bleeding. Underexpansion of the stent may result in insufficient vessel expansion. Insufficient contact of the parts of the stent with the vessel wall may increase the risk of thrombosis. Underexpansion of the stent may not restore normal blood flow. It is clear that a variety of problems can occur after the stent is placed if the stent is overexpanded or underexpanded.

[0006] Another challenge associated with stent placement and related procedures is that the use of angiography systems to visualize the deployment of the stent relative to the vessel wall is impractical.

[0007] Furthermore, manually reviewing images to identify stent location on an image-by-image basis is also prone to error. Thus, there is a need for systems, methods, and devices that use intravascular diagnostic information to facilitate assessment of vessel coverage by a stent, or the coverage of the stent itself. Summary of the Invention [Problem to be solved by the invention]

[0008] The present disclosure addresses these and other challenges. [Means for solving the problem]

[0009] The present disclosure relates in part to systems, methods, and devices for evaluating a stent placed in a vessel relative to one or more planning stages and geometries acquired for the vessel or stent. The geometries and information for the vessel or stent can be acquired using an intravascular data acquisition system and associated probe, such as optical coherence tomography (OCT) or intravascular ultrasound (IVUS) or other intravascular data acquisition modalities. Additionally, the present disclosure provides a user (e.g., a clinician or other person) with an automated method for evaluating whether a stent placed in a vessel has expanded to an appropriate level (e.g., a substantially optimal level or other suitability metric). These metrics, in one embodiment, may be specified by the user. If the stent is overexpanded, improperly positioned, or occluding a side branch, these conditions can also be evaluated using the methods and systems described herein.

[0010] The disclosure relates in part to a method for evaluating stent deployment in a blood vessel, the method including: generating, using one or more computing devices, a representation of a segment of the blood vessel using a first endovascular data set acquired for the blood vessel; receiving a selection of a distal or first fiducial relative to the representation of the segment of the blood vessel; receiving a selection of a proximal or second fiducial relative to the representation of the segment of the blood vessel; generating, using one or more computing devices, a target stent profile based on the distal and proximal fiducials; generating, using one or more computing devices, a vessel lumen profile after deployment of the stent in the blood vessel; comparing the target stent profile to one or more regions of the vessel lumen profile; and generating, using a user interface, an output including one or more differences resulting from comparing the target stent profile to the one or more regions. In one embodiment, generating the output includes displaying one or more outputs representative of a correlation or goodness of fit between the target stent profile and the one or more regions of the vessel lumen profile. In one embodiment, the first reference may be a distal reference, such as a user selected distal frame, and the second reference may be a proximal reference, such as a user selected proximal frame, or the first reference may be a proximal reference, such as a user selected proximal frame, and the second reference may be a distal reference, such as a user selected distal frame.

[0011] The method may include displaying an indicator of side branch occlusion based on one or more side branches not detected when comparing the target stent contour with one or more regions of the vessel lumen contour. In one embodiment, the one or more outputs are a visual depiction of the overlap of the target stent contour with one or more regions of the vessel lumen contour. In one embodiment, the one or more outputs are comparative metrics of changes in a measured or calculated parameter relative to the segment of the vessel. In one embodiment, the parameter is selected from the group consisting of fractional flow reserve, flow rate, vascular resistance ratio, virtual fractional flow reserve, simulated fractional flow reserve, measured fractional flow reserve, and pressure measurements.

[0012] In one embodiment, the method includes using one or more computing devices to generate a vessel lumen contour after deploying a stent in the vessel, the step including generating a representation of a segment of the vessel using a second endovascular data set acquired for the vessel. In one embodiment, the first endovascular data set is acquired during a first optical coherence tomography imaging session. In one embodiment, the second endovascular data set is acquired during a second optical coherence tomography imaging session.

[0013] In one embodiment, the method includes generating and displaying a difference between a post-stent lumen profile and a pre-stent target profile, or generating and displaying a value correlated to the difference per frame or per segment. In one embodiment, the method includes detecting one or more side branches in the vessel. In one embodiment, the method includes adjusting a shape of the target stent profile for each side branch. In one embodiment, the method includes adjusting the shape, which includes stepping up the stent profile each time a side branch is detected if the distal reference diameter is smaller than the proximal reference diameter. In one embodiment, the method includes adjusting the shape, which includes stepping down the stent profile each time a side branch is detected if the distal reference diameter is larger than the proximal reference diameter.

[0014] The present disclosure relates in part to a processor-based stent deployment evaluator or evaluation system, the system or evaluator including one or more memory devices and a computing device in communication with the memory devices, the memory devices including instructions executable by the computing devices to cause the computing devices to: generate a target stent profile in response to one or more user selections from a user interface, the user interface displaying a first representation of the vessel, the user selections including proximal and distal fiducials; generate a second representation of the vessel after stent deployment, display the second representation; and display one or more parameters relative to the second representation of the vessel, the one or more parameters indicative of under-extension, over-extension, or overlap with a side branch of the deployed stent.

[0015] The drawings are not necessarily to scale, emphasis instead being placed primarily on illustrating the principles. The drawings are to be considered in all respects illustrative and are not intended to limit the disclosure, the scope of which is defined solely by the claims. [Brief description of the drawings]

[0016] [Figure 1] 1 is a schematic diagram of a data collection system and a data collection probe according to an exemplary embodiment of the present disclosure. [Diagram 2] 1 is a schematic diagram of a data collection system and a data collection probe positioned relative to a stent in a blood vessel, according to an exemplary embodiment of the present disclosure. [Diagram 3] FIG. 1 is a schematic diagram of the lumen profile of an intravascularly imaged blood vessel, showing four side branches, the lumen profile (LP), and a target stent profile (TSP) generated on a computing device, according to an exemplary embodiment of the present disclosure. [Figure 4]1 is a schematic diagram of the luminal contour of a vessel after a stent has been deployed relative to the LP, according to an exemplary embodiment of the present disclosure, as shown, two side branches are blocked after stent placement, and after the second pullback, only two side branches are detected. [Diagram 5] At the top of the figure is a schematic diagram of the stent planning of FIG. 3, which provides a pre-stent target profile that serves as input for the post-stent comparative analysis, according to an exemplary embodiment of the present disclosure. [Figure 6] FIG. 1 is a schematic diagram of an intravascular data processing software module or component suitable for receiving data acquired relative to a vessel segment and generating outputs and constraints suitable for implementing the methods disclosed herein. [Figure 7] 1 is a flow chart illustrating an exemplary method for evaluating a deployed stent through intravascular data collection, according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0017] The present disclosure relates in part to computer-based methods, devices, and systems suitable for pre-stent, stent, and post-stent planning using one or more computing devices. The one or more devices can display one or more user interfaces and endovascular data or other information derived from such data. The endovascular data can be acquired by IVUS or OCT-based data acquisition systems and probes, or other imaging modalities. The methods can be implemented using one or more computing devices and memory storage, including one or more software components that receive the endovascular data and user input via a graphic user interface (GUI) and perform image processing and frame selection. The computing devices can be microprocessors, ASICs, or other processors suitable for use with intravascular imaging systems.

[0018] As shown in FIG. 1, the probe 7 is shown before or after insertion into a blood vessel. The probe 7 may, in one embodiment, include other imaging modalities, such as ultrasound, in addition to or instead of OCT. The probe 7 is in optical communication with an OCT system 10 or other imaging system (e.g., an IVUS system). The OCT system or subsystem 10, which interfaces with the probe 7 via optical fiber 15, may include a light source, such as a laser, an interferometer having a sample arm and a reference arm, various optical paths, a clock generator, photodiodes, and other OCT system components.

[0019] The system 10 includes stent profile analysis software 9. This software may be stored as non-transient instructions in one or more memory devices, such as memory device 45, and may be executed by one or more computing devices, such as computing device 40. The stent profile analysis software may include a comparator or other comparison software routine for comparing one or more profiles (e.g., a user-generated target profile), pre-stent and post-stent profiles, or other profiles. The stent profile analysis software 9 may include an overlay method suitable for overlaying an image of a deployed stent relative to a target profile, or one or more pre-stent or post-stent profiles of another overlay. The software 9 may also include a side branch occlusion indicator software module that identifies when a side branch and a stent overlap. The software 9 may also compare FFR, VRR, and other values ​​determined for the first and second endovascular data collection sessions, also referred to as pullbacks. The stent contour analysis software 9 may include the software components shown in Figure 1 and others to carry out the methods and features described herein. The software 9 may also be part of a pipeline of other intravascular data processing modules, such as that shown in Figure 5.

[0020] In one embodiment, a light receiver 31 (e.g., a balanced photodiode-based system) can receive light emitted from the probe 7. A computing device 40 (e.g., a computer, processor, ASIC, or other device) can be part of the OCT system 10 or can be included as a separate subsystem in electrical or optical communication with the OCT system 10. The computing device 40 can include memory, storage, buses, and other components suitable for data processing, and software 44, e.g., image data processing stages configured for stent visualization, stent maladaptation detection, and pullback data collection, as described below.

[0021] In one embodiment, the computing device 40 includes or has access to software modules or programs 44, such as software modules such as a side branch detection module, a guidewire detection module, a lumen detection module, a stent detection module, a middle mask removal module, an intensity averaging module, a stent maladaptation detection module, a stent planning module, a stent analysis module, an FFR measurement module, a VRR measurement module, etc. The software modules or programs 44 may include an image data processing pipeline or its component modules and one or more graphical user interfaces (GUIs). An exemplary image processing pipeline 50 for converting collected OCT data into two-dimensional and three-dimensional views of vessels and stents is shown in FIG. 5. The image data processing pipeline, or any of the methods described herein, may be stored in memory and executed by one or more computing devices (e.g., processors, devices, or other integrated circuits).

[0022] As shown in FIG. 1, a display 46 may be part of the system 10 for displaying information 47, such as cross-sectional and longitudinal views of a vessel, generated using collected OCT data. This OCT-based information 47 may be displayed by one or more graphic user interfaces (GUIs). Additionally, this information 47 may include, but is not limited to, cross-sectional scan data acquired using an OCT or IVUS system and data collection probe, longitudinal scan results, diameter graphs, target stent outer diameter, proximal fiducials, distal fiducials, pre-stent and post-stent FFR values, or basic distance measurements. The computing device 40 may include software or programs 44, which may be stored in one or more memory devices 45, and may be configured to identify side branches, under-bulged stent areas, and other stent deployment measurements or calculations, as well as other vessel features, such as by text, arrows, color coding, highlighting, outlines, or other suitable human or machine readable indicia.

[0023] Once the OCT data has been acquired by the probe and stored in memory, it may be processed to generate information 47, such as cross-sectional, longitudinal, and / or three-dimensional views of the blood vessel along the length of the pullback region or a portion thereof. These views may be depicted as part of the user interface, as shown in the drawings. Vascular images generated using distance measurements acquired from the OCT system provide information about the blood vessel and objects located within the blood vessel.

[0024] In one embodiment, a method generates one or more stent profiles (e.g., target stent profiles), which can be configured by a user during the pre-stent planning stage by selecting one or more reference frames. The method performs a comparative analysis of the pre-defined target stent profile and the vessel lumen area after stent deployment. The method and associated user interface can alert the user to move the stent, remove the stent, reposition the stent, or inflate the stent. Based on this comparative analysis, the location of the side branch occlusion can also be identified and displayed. Parameters that change based on the results of stent deployment can be displayed with respect to predicted parameter values ​​and values ​​measured or calculated after stent deployment. These parameters can provide an indication to the user that the stent needs to be moved or inflated as a result of the parameter values ​​being smaller than the target parameters set during the planning stage.

[0025] The present disclosure relates in part to computer-based methods, systems, and devices for visualizing a stent. In one embodiment, the present disclosure relates to methods for evaluating the spread of a stented vessel and whether further spread or repositioning of the stent is required. These evaluation methods may include displaying one or more views of the stent in various states (e.g., spread relative to the vessel) and comparing the imaged stent relative to one or more selected stent profiles. In one embodiment, the methods are performed automatically. The methods of the present disclosure may be performed by software, such as stent profile analysis software, which may include stent planning software and lesion preparation software (or vice versa).

[0026] Selection of a stent for deployment may be made by acquiring OCT, IVUS, angiography, or other probe data relative to an unstented vessel segment and then comparing it to the stented vessel. The stented and unstented phases of the stent plan may be displayed sequentially longitudinally or as expanded or unexpanded cross-sectional views as part of one or more graphic user interfaces (GUIs). Such interfaces may include one or more angiograms generated using distance measurements acquired by the OCT, IVUS, angiography, or other data acquisition systems.

[0027] In one embodiment, the method includes receiving a target stent expansion profile set by the user during the pre-stent planning stage. The method can also compare the target profile to one or more areas of the vessel lumen after stent deployment. The method provides an accurate process for comparing the target stent profile to the current expansion of the stent. In the case of bioresorbable stents (BRS), where the user can only attempt to expand the stent once deployed, indicating the area where the stent needs to be expanded also helps to determine where to inflate the balloon and where to select the size of the balloon after the stent is expanded. Then, one pullback is performed by the imaging probe to recognize the lumen environment and this is compared to the result of a second pullback after stent deployment. The second pullback can be performed immediately after stent deployment so that the stent can be further expanded, repositioned, or removed. In one embodiment, the stent plan can be input from the GUI and stored in memory for use and comparison with other endovascular data and images.

[0028] The stent plan may include a first location, such as a start frame, and a second location, such as an end frame. The stent plan may include multiple stent diameters. In one embodiment, the stent plan includes first and second locations along the imaged vessel and stent diameters at the first and second locations. The stent plan may include multiple frames, which are generated using optically or acoustically measured data and parameters within the vessel, such as optical coherence tomography or IVUS data and parameters. The frames may include longitudinal, cross-sectional, or other views or images or data acquired relative to the vessel during one or more time periods. As an example, the first time period may include a first pullback, during which the vessel is imaged. Similarly, the second time period may include a second pullback, during which the vessel is imaged. In one embodiment, the stent plan may include stent diameters in one or more frames in addition to the first and second frames, such as the first and second frames, or frames between the first and second frames, and combinations thereof. In one embodiment, the stent diameters of each frame including the first and second frames, or each frame following the first and second frames, are included in the stent plan.

[0029] Optical Coherence Tomography (OCT) is an imaging modality that uses interferometry to obtain distance measurements relative to a sample, such as a blood vessel or an object placed within a blood vessel. Intravascular Ultrasound, or IVUS, is an ultrasound or acoustic wave based imaging modality. Either or both of these may be combined in an intravascular data collection probe. As shown in FIG. 2, a blood vessel 5 may be imaged by a data collection probe 7. As shown in FIG. 2, the probe 7 may be introduced into the blood vessel 5 using a guide wire 8. Examples of images or data of a blood vessel generated from data collected by the probe or the like are shown in FIGS. 3, 4, and 5.

[0030] The data collection probe 7 can be introduced along the length of the blood vessel 5 and pulled back while collecting data. As the optical fiber is retracted (pulled back) along the length of the blood vessel, the probe or a portion thereof is rotated and multiple scans or OCT data sets are collected, which in one embodiment are referred to as pullbacks. These data sets can be used to identify regions of interest, such as areas of stenosis and areas where a stent, such as the stent 12, has been deployed. In one embodiment, a first pullback is performed before stent deployment and a second pullback is performed after stent deployment. Angiographic data can be generated during both the first and second pullbacks relative to the imaged blood vessel. Regions of interest and parameters, such as vascular resistance ratio, FFR, lumen area, lumen geometry, and other parameters, can be compared between the first and second pullbacks.

[0031] In one embodiment, the data collection probe 7 is an OCT probe configured for use with an OCT system 10 that includes an interferometer and a data processing system. Distance measurements collected using the OCT probe 7 can be processed to generate frames of image data, such as cross-sectional or longitudinal views (L-mode views) of a blood vessel. For clarity, cross-sectional views may include, but are not limited to, longitudinal views. These images may be processed by one or more image data processing modules or stages as outlined herein.

[0032] In the blood vessel 5 shown in FIG. 2, a stent 12 is placed in the lumen 14 of the blood vessel, and various types of data collection probes and associated OCT systems may be used. In one embodiment, the OCT system 10 includes a processor, memory, or other components configured to execute various data processing steps or modules. These steps or modules operate on and transform image data. These modules or steps may include a stent detection software component and a stent maladaptation detection component. A given stent and its components may be visualized to include an indication or measurement of the degree of contact or lack of contact between one or more stent struts that are components of the stent and the vessel wall. One area showing the degree of under-expansion of the stent relative to the stent 12 and wall 26 is shown as area 18. The displays of FIGS. 4 and 5 may be used by the user as a diagnostic to further expand the stent in such a situation. These features are described in more detail herein.

[0033] As shown in FIG. 2, in a given blood vessel, the walls of the vessel define a lumen through which blood flows. An X-ray based imaging modality, such as that provided by angiography system 13, can be used to image the blood vessel to facilitate stent deployment or stent visualization. Additionally, as described herein, a probe 7 suitable for insertion into blood vessel 5 can be used to generate images of cross-sections of the given blood vessel. Various cross-sectional and three-dimensional views of the blood vessel obtained by the OCT system and associated data collection probes can be used to display stenotic regions or a deployed stent, such as stent 12, which is disposed in lumen 14.

[0034] 2 is a high level schematic diagram illustrating a data collection probe and OCT system 10 suitable for performing side branch detection, lumen detection, guidewire detection, and various other processes. The OCT system 10 may include a suitable light source to meet the coherence and bandwidth requirements of the applications and data collection described herein. The probe 7 may include a catheter 20 having a catheter portion with one or more optical fibers 15 and a probe tip 17 disposed therein. The probe tip 17 includes a beam director in one embodiment.

[0035] As shown, a catheter 20 is introduced into a lumen 14, such as an arterial lumen. The probe 7 may include a rotating or slidable fiber 15 that directs light into the lumen 14 or in a direction perpendicular to the longitudinal axis of the fiber 15. As a result, when the fiber 15 rotates and light is directed from the side of the probe, OCT data is collected for a wall 25 of the blood vessel 5. The wall of the blood vessel 25 defines the lumen boundary, which can be detected from distance measurements obtained from the optical signals collected at the probe tip 17 using a lumen detection software component or module. Instead of a fiber, an ultrasound transducer suitable for collecting IVUS signals related to the vessel wall and one or more stents may be used.

[0036] The lumen detection software may include one or more steps. For example, in one embodiment, to perform lumen detection, a filter or other image processing device may be applied to the two-dimensional image to detect edges in the image that represent the lumen boundary. In another embodiment, a scan-line based method is used. During one or more pullbacks, optical or ultrasound signals are collected as scan lines of the blood vessel and one or more stents disposed in the lumen of the vessel. In one embodiment, the lumen detection software running on the computing device uses the computing device to generate one or more images from a series of scan lines.

[0037] Further, the lumen detection may include using a computing device to generate a binary mask of the vascular image, the binary mask being generated using an intensity threshold. As another step, a plurality of scanlines are defined within the binary mask. For each scanline of the plurality of scanlines, in one embodiment, an area identified as lumen border tissue is thereon. A contour segment of the boundary is identified based on the presence of the area of ​​lumen border tissue. In one embodiment, the method identifies adjacent contour segments. The lumen border detection method may include the step of interpolating missing contour data between adjacent contour segments. As a result, in one embodiment, the adjacent contour segments and the missing and interpolated contour data define the lumen border.

[0038] As shown in FIG. 2, the probe tip 17 is positioned in the lumen 14 such that it is distal to the stented region of the vessel 5, as bounded by dotted lines A, B. The probe tip 17 is configured to transmit light and receive backscattered light from objects (e.g., stent 12) and the wall 25 of the vessel 5. The probe tip 17 and the rest of the data collection probe 7 are pulled through the lumen 14 such that the tip passes through the stented region, as defined by lines A, B. A target stent profile (TSP) generated in response to a user-selected frame of reference is shown between the deployed stent lines A and B. The target stent profile is generated by one or more methods described herein, including one or more user-provided frames of reference or other selections relative to an identified portion of the vessel as input. In one embodiment, the target stent profile is automatically placed or overlaid over the region of the lumen profile that corresponds to the detected stent struts, as shown in FIG. 5.

[0039] Accordingly, the present disclosure relates in part to software-based methods and associated systems and devices suitable for evaluating and depicting information related to a blood vessel, stent, or other vascular information of interest. OCT data can be used to generate 2-D views, such as cross-sectional and longitudinal views, of the blood vessel before or after initial stent deployment or a stent-related revision procedure. OCT data acquired using a data collection probe and various data processing software modules can be used to identify, characterize, and visualize one or more properties associated with the stent and / or the lumen in which the stent is located.

[0040] Furthermore, once such two-dimensional or three-dimensional images have been generated or basic measurements are available in a data store such as a database or memory device, the diagnostic task can be further enhanced by obtaining measurements relative to the vessel and stent. For example, measurements related to the stent, such as the degree to which the stent profile is misaligned, can be generated automatically using the OCT data without the user having to be involved in the calculations.

[0041] In one embodiment, as shown in FIG. 2, an angiography system 13 may be used to obtain a high level view of the vessel of interest. This step may precede or occur simultaneously with the pullback of the rotatable OCT probe. As an example of such a procedure, if a mismatch between the stent profile and the stent profile is automatically identified and displayed by the software such that there is a correlation or lack of correlation with the user, the user may choose to use a balloon to further inflate the deployed stent. The balloon may be placed with the assistance of the angiography system 13, and the balloon may be inflated to change the state of the stent and reduce the degree of under-inflation. In one embodiment, a further OCT pullback may be performed to inspect the placed stent. Stent detection, stent placement, and lumen detection may be performed using multiple software modules organized in an image data processing pipeline that take image or OCT data as input.

[0042] In the stent planning stage, a computing device, such as a processor or microprocessor, in electrical communication with the endovascular data collection system is used to determine a target stent spread profile (also referred to as TSP or target stent profile). The target stent profile is generated based on one or more user selections, such as user-selected reference regions in the proximal and distal regions, as shown in FIG. 3. By setting the proximal and distal references along with associated lumen diameters, the user defines the target region, a segment of the vessel, for stent placement. In FIG. 3, the lumen diameters and mid-branch diameters at the proximal and distal reference regions generate an optimal stent placement taper shape connecting the proximal and distal reference regions. The vertical dotted line in FIG. 3 is the minimum lumen area value (MLA).

[0043] The stent profile is a constant in a given segment between the reference frames. The end-to-end branch profile is linearly interpolated; that is, the physiological tapering of the vessel along its length and the proximal and distal fiducials generate the upper and lower boundaries of the target stent profile. If the reference frames are in the same segment (i.e., there are no branches between the reference frames), the stent profile is a linear interpolation between the two reference frames.

[0044] In one embodiment, the method adjusts the profile geometry by stepping up the target stent profile at each branch point going from distal to proximal if the distal reference diameter is less than the proximal reference diameter, and stepping down the target stent profile at each segment going from distal to proximal if the distal reference diameter is greater than the proximal reference diameter. In this manner, the user selection of the reference end points, the tapering characteristics of the vessel and associated flow, and other changes due to side branches are considered and modeled to recognize the expected changes that would be caused by stent placement.

[0045] If the distal and proximal reference frames are in the same segment, the stent profile is a linear interpolation between the distal and proximal reference frames. In one embodiment, the method for determining the target stent profile in response to one or more user selected reference frames is as follows. Let N be the total number of side branches between the reference frames. For example, in Figure 3, four (N=4) side branches are shown between the most distal and most proximal frames of the illustrated segment: one side branch at the top of the lumen and three at the bottom. exp=2.3 is the scaling exponent. In one embodiment, the exponent value ranges from about 2 or more to about 3 or less. This exponent value indicates the scaling of the segment taper between the user selected reference frames. Selection of the best value of the exponent is based on a statistical analysis of an image database of OCT and angiography, where the taper of blood vessels and their branch diameters are measured. In normal subjects, the exponent value ranges from about 2.2 to about 2.7. The difference between the proximal and distal reference diameters is:

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[0046] The segment diameters mentioned above provide a delta measurement, and when a tapered boundary is created throughout the vessel segment, the upper and lower taper boundaries of the target stent profile change in a stepwise manner, such as the delta measurement. During the pre-stent deployment or stent planning stage, the target stent flare profile (pre-stent target) sets a target for the user. The user interface presents stent size options to assist the user in selecting an appropriately sized stent for a given target profile.

[0047] After the stent is deployed, a stent detection algorithm locates the stented lumen area. The lumen contour of the stented area is compared to the pre-stent target. Any over- or under-expansion can be automatically highlighted for user analysis. A quantified error measure can be generated that indicates the per-frame or per-segment error between the post-stent lumen contour and the pre-stent target contour. This error measure can assist the user in selecting an appropriate size balloon to expand the stent after deployment. This error measure can include the distance that the post-stent lumen contour differs from the pre-stent target contour.

[0048] In one embodiment, the stent profile or stent planning software uses the predicted VFR or FFR or other intravascular parameters in the pre-stent planning stage and compares it with the VFR or FFR or other intravascular parameters achieved after stenting. The difference in measurements such as predicted FFR - post-stenting FFR may also be displayed to guide the user to the changes related to stent deployment. If the values ​​of these parameters are close, the assisted stenting will achieve the predicted results, if the differences are significant, the stent may need to be repositioned or further inflated. If the comparison results in the need to change the stent expansion level, the user interface can automatically provide guidance by identifying areas on the vessel image where the balloon should be inflated.

[0049] The system can also display the amount of improvement in the VFR value, further assisting the user in the post-stent analysis phase. The occurrence of side branch occlusion can be displayed by comparing pre- and post-segment image data, and an indicator can be used if such occlusion requires migration of the deployed stent.

[0050] The pre-stent profile is used for comparison with the post-stent lumen because a stent profile calculated using only the post-stent pullback fails to account for any side branches that may be occluded or blocked during stent deployment.

[0051] An exemplary workflow that allows intravascular imaged vessels to be used for stent placement, stent selection, and assessment of stent spreading level is given below: If the distal and proximal reference frames are in the same segment, the stent profile is a linear interpolation between the distal and proximal reference frames.

[0052] Pre-stent planning: The physician uses a stent planning tool to determine the segment of the vessel with the lesion or other stenosis where the stent will be placed and the size of the stent. The tool may include a user interface display as shown in FIG. 3. Selection of criteria specifies a range of possible stent sizes. A first user-selected criterion R1 is shown on the left or distal side of the interface. A second user-selected criterion R2 is shown on the right or proximal side of the interface. This process is performed using one or more user interfaces that may include displays and metrics related to one or more endovascular data sets. A target stent profile TSP based on a user-provided reference frame is shown narrow relative to the lumen profile contour with upper and lower boundaries shown as horizontal lines. Lumen profile LP is shown on either side of the target stent plan along the center of the vessel, bounded by the upper and lower contours by the TSP as shown in FIG. 3.

[0053] These data sets may include OCT or IVUS data sets acquired during pullback through the vessel. In FIG. 3, four side branches SB1-SB4 are shown in the image of the vessel. The lumen is shown as the central dark area with the distal end on the left and the proximal end on the right. The vertical dotted lines correspond to the MLA. The decision to place a stent may be based on the VFR or the measured FFR. A reference frame is selected and in response, a predicted VFR (VFRp), stent length, and target stent profile are generated. These values ​​can be compared with the VFR or FFR expected during planning and with measurements acquired after stent deployment to assess the effect of the stent in the vessel and the need for further inflation or redoing the stent placement.

[0054] Post-stent analysis: After the stent is deployed as shown in the interface or display representation of FIG. 4, a new pullback is taken to collect intravascular data relative to the vessel and the newly deployed stent. As shown in the new pullback, in contrast to FIG. 3, in the second pullback shown in FIG. 4, two side branches SB1 and SB4 are blocked after stenting, and only two side branches SB2 and SB4 are detected. In one embodiment, the stent profile analysis software automatically identifies the stented area using a stent detection function. The lumen outline LP of the stented area is displayed with the target stent outline TSP overlaid, as shown in FIG. 5.

[0055] As shown in Figure 5, after stenting, the VFR values ​​obtained in a second data collection session, such as OCT or IVUS pullback, are displayed along with the (predicted) VFRp of the pre-stent planning stage. If the post-stent VFR is less than the pre-stent planning stage VFRp, the stent was deployed below the desired target, whereas if it is greater than the VFRp, the stent was successfully placed meeting the target VFR. These diagnostic differential measurements using pullbacks before and after stent deployment facilitate the assessment of what would have happened if any changes had been made relative to the stented vessel and the associated stent(s).

[0056] As shown, in FIG. 5, the lumen profile is shown and the planned pre-stent target profile is shown in dotted lines. The stent profile is automatically placed over the regions of the lumen profile LP that correspond to the detected stent struts. In the bottom panel of FIG. 5, a longitudinal view of the detected stent struts is shown. In FIG. 5, the stent is relatively underbulged relative to the target stent profile as shown. The target stent profile includes upper and lower tapered boundaries shown in dotted lines in FIG. 5. This occurs because the detected struts of the stent identified by the image processing pipeline do not extend to the horizontal line shown. FIG. 5 represents a vessel segment selected by proximal and distal fiducials, which includes a schematic representation of the stent and the target stent profile. The interface may include images of the stent in the bottom panel that can be viewed from various angles. The panels of the user interface display of FIG. 5 need not all be displayed at the same time, but one or more of them may assist the user in deciding whether to expand, move, or leave the stent in place after stent deployment.

[0057] An exemplary image processing pipeline 50 for converting collected OCT data into two-dimensional and three-dimensional views of the vessel and stent and for comparing the contours relative to the deployed stent is shown in FIG. 6. The image data processing pipeline, or any of the methods described herein, is stored in memory and executed by one or more computing devices (e.g., processors, devices, or other integrated circuits). In one embodiment, the computing device 40 includes or has access to software modules or programs 44, such as a side branch detection module, a guidewire detection module, a lumen detection module, stent deployment analysis software (e.g., software 9 of FIG. 1), and other software modules. The software modules or programs 44 may include the image data processing pipeline or its component modules and one or more graphical user interfaces (GUIs).

[0058] As shown in FIG. 6, a display 46 may be part of the system 10 to display information generated using the collected endovascular data, such as cross-sectional and longitudinal views of the vessel (e.g., the vessel segment views and profiles of FIGS. 3, 4, and 5, as well as others described herein). This information 47 may be displayed using one or more graphic user interfaces (GUIs). Additionally, this information 47 may include, but is not limited to, cross-sectional scan data, longitudinal scan results, lumen profiles, VRR values, FFR values, stents, areas of poor attachment, lumen boundaries, side branch occlusion, and other images or representations of the vessel or basic distance measurements obtained using the system 10 and data collection probe. Computing device 40 may include software or programs 44, which may be stored in one or more memory devices, and may be configured to identify deviations between target stent profiles, lumen contours, and stent plans and the results of deployed stents and other vascular features, such as by text, arrows, color coding, highlighting, outlines, or other suitable human or machine readable indicia.

[0059] Once the OCT data has been acquired by the probe and stored in memory, it may be processed to generate information, such as cross-sectional, longitudinal, and / or three-dimensional views of the blood vessel along the length of the pullback region or a portion thereof. These views may be shown as part of a user interface, such as those shown in Figures 3, 4, and 5. Blood vessel images generated using distance measurements acquired from the OCT system provide information about the blood vessel and objects located within the blood vessel.

[0060] As shown, the pipeline may receive post-stent deployment pullback data 52, which may come after the first pullback to image the vessel. A user selection may be received via a GUI and the stent planning data may be transferred to a stent profile or stent deployment analysis software, such as software 9 of FIG. 1. The guidewire 54, side branch detection 56, stent detection 58, and lumen detection modules may operate on the post-stent deployment pullback data, which may be collected scanlines. The software 62 may perform various steps described herein, such as performing profile overlays, parameter comparisons (e.g., VFR before and after stent placement), and subtractions from the stent planning and results of stenting the vessel.

[0061] 7 illustrates an exemplary process flow for performing a relative diagnostic evaluation on a deployed stent. In one embodiment, the method includes steps A through E, or portions thereof, involving one or more user selections from an intravascular imaging system. In one embodiment, step A includes generating a representation of a segment of a vessel using the intravascular data. In one embodiment, step B includes receiving a selection of a first fiducial relative to the representation of the segment of a vessel. The first and second fiducials may include a frame or other portion of the intravascular segment representation.

[0062] These criteria are generated by a user interface, which communicates signals or commands to the software 9, or other software components described herein. In one embodiment, step C includes receiving a selection of a second criterion relative to the representation of a segment of the blood vessel. In one embodiment, step D includes generating a target stent profile using the first and second criteria. In one embodiment, step E includes generating a vessel lumen profile after the stent is deployed in the blood vessel. In one embodiment, step F includes comparing the target stent profile to one or more regions of the vessel lumen profile. In one embodiment, step G includes displaying an output including one or more differences from the comparison.

[0063] Typically, OCT images, such as the longitudinal image of the bottom panel of FIG. 5, including the detected stent struts, are acquired one scan line at a time. A series of samples along a ray emanating from the center of the catheter toward the maximum imaging depth is referred to as a scan line. Thus, a given scan line may correspond to a one-dimensional cue or indicia of a stent strut or stent portion. As the probe rotates, scan lines are collected to form a cross-sectional image.

[0064] As shown in Figures 1 and 2, the probe collects data during pullback regarding the stenotic region, the vessel wall, and the stent struts. In one embodiment, the light data enters the probe at the probe tip. The probe tip may include a beam director, such as a lens or reflector or a combination thereof, that is part of the probe and directs the beam onto the vessel wall. The probe tip also receives scattered light returning from the vessel wall.

[0065] In one embodiment, if the stents do not overlap, then a stent strut is one point in the set of points for a given scan line. A cross-sectional image can be formed from a series of scan lines collected as the probe rotates. Furthermore, when imaging a segment of an artery or other blood vessel, the catheter is moved longitudinally while being rotated. In this manner, the probe acquires a series of cross-sectional images of a helical pattern.

[0066] The systems and software-based methods described herein can process frames of optical coherence tomography data acquired of a blood vessel such that a stent placed within the vessel can be evaluated or otherwise characterized. In one embodiment, each cross-sectional image can constitute a frame of OCT image data. For example, in one embodiment, such identification of a stent is performed in a graphic user interface that displays a three-dimensional or two-dimensional image of the blood vessel that is generated using the collected OCT data.

[0067] The software modules described herein, as well as the functionality for assessing and displaying the extent of a stented vessel, may be implemented using a non-transitory computer-readable storage medium. In one embodiment, the non-transitory computer-readable storage medium stores a program that, when executed by a computing device, causes the computing device to implement a method for processing or otherwise acting on intravascular image data and intravascular parameters. Each method may include one or more of the steps outlined herein. Non-Limiting Software Functionality and Embodiments for Implementing the Stent Planning and Post-Deployment Diagnostics Method and System

[0068] The following description is intended to provide an overview of device hardware and other operating components suitable for implementing the disclosed methods described herein. This description is not intended to limit the applicable environment or scope of the disclosure. Similarly, these hardware and other operating components may be suitable as part of the devices described above. The disclosure may also be practiced with other system configurations, such as personal computers, multiprocessor systems, microprocessor-based or programmable electronic devices, network PCs, minicomputers, mainframe computers, and the like. The disclosure may also be practiced in distributed computing environments where tasks are performed by multiple remote processing devices, such as in different rooms of a catheterization lab, that are linked through a communications network.

[0069] Some portions of the above detailed description are presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. Those skilled in the art of computers and software related fields may employ such algorithmic descriptions and representations. In one embodiment, an algorithm is here, and generally, conceived to be a self-consistent sequence of operations leading to a desired result. The operations performed as method steps or otherwise herein are operations requiring physical manipulations of physical quantities. Usually, although not necessarily, such quantities take the form of electrical or magnetic signals capable of being stored, transferred, combined, transformed, compared, or otherwise manipulated.

[0070] As will become apparent from the description that follows, unless otherwise indicated, discussions throughout the description utilizing terms such as "processing," or "calculating," or "overlaying," or "searching," or "detecting," or "measuring," or "calculating," or "comparing," or "generating," or "determining," or "displaying," or set-related operations such as Boolean logic, or the like, will be understood to refer to operations or processes of a computer system or electronic device that manipulates and converts data represented as physical (electronic) quantities in the registers and memories of a computer system or electronic device into other data that is also represented as physical quantities in electronic memories or registers or other such devices for storing, transmitting, or displaying information.

[0071] The present disclosure also relates in some embodiments to apparatus for performing the operations described herein, which may be specially constructed for the required purposes, or may comprise a general-purpose computer selectively activated or reconfigured by a computer program stored in the computer.

[0072] The algorithms and displays presented herein are not inherently related to any particular computer or other apparatus. Various general-purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct a more specialized apparatus to perform the required method steps. The required structure for a variety of these systems will appear from the description that follows. In addition, the description of the present disclosure is not with reference to any particular programming language, and various embodiments may be implemented using a variety of programming languages.

[0073] The embodiments of the present disclosure may be implemented in a variety of forms, including but not limited to computer program logic used in conjunction with a processor (e.g., a microprocessor, microcontroller, digital signal processor, or general purpose computer), programmable logic used in conjunction with a programmable logic device (e.g., a field programmable gate array (FPGA) or other programmable logic device), discrete components, integrated circuits (e.g., an application specific integrated circuit (ASIC)), or any other means including any combination thereof. In an exemplary embodiment of the present disclosure, some or all of the processing of data collected using an OCT probe and processor-based system is implemented as a series of computer program instructions that are converted into a computer-executable format, stored in that format on a computer-readable medium, and executed by a microprocessor under the control of an operating system. Thus, query responses and input data are converted into processor understandable instructions suitable for generating OCT data, detecting lumen boundaries, detecting stent struts, comparing measured vertical distances to set thresholds, and otherwise implementing image comparison, signal processing, artifact removal, and other features and embodiments described above.

[0074] Computer program logic implementing all or part of the functionality previously described herein may be embodied in various forms, including but not limited to source code form, computer executable form, and various intermediate forms (e.g., forms generated by an assembler, compiler, linker, or locator). Source code may include a series of computer program instructions implemented in any of a variety of programming languages ​​(e.g., object code, assembly language, or high level languages ​​such as Fortran, C, C++, JAVA, or HTML) used with a variety of operating systems or operating environments. Source code may define and use various data structures and communication messages. Source code may be in a computer executable form (e.g., via an interpreter) or may be converted into a computer executable form (e.g., by a translator, assembler, or compiler).

[0075] The computer program may be fixed in any form (e.g., source code form, computer executable form, or intermediate form) permanently or temporarily on a tangible storage medium, such as, for example, a semiconductor memory device (e.g., RAM, ROM, PROM, EEPROM, or flash programmable RAM), a magnetic memory device (e.g., diskette or fixed disk), an optical memory device (e.g., CD-ROM), a PC card (e.g., PCMCIA card), or other memory device. The computer program may be fixed in any form on a signal that can be transmitted to a computer using any of a variety of communication technologies, including, but not limited to, analog, digital, optical, wireless (e.g., Bluetooth), networking, and internetworking technologies. The computer program may be distributed in any form on a removable storage medium (e.g., shrink-wrapped software) accompanied by printed or electronic documentation, preloaded on a computer system (e.g., in a system ROM or fixed disk), or distributed by a communication system (e.g., the Internet or World Wide Web) from a server or electronic bulletin board.

[0076] Hardware logic (including programmable logic for use in conjunction with a programmable logic device) implementing all or a portion of the functionality previously described herein may be conventionally hand designed, or may be electronically designed, captured, simulated, and documented using a variety of tools, such as computer-aided design (CAD), hardware description languages ​​(e.g., VHDL or AHDL), or PLD programming languages ​​(e.g., PALASM, ABEL, or CUPL).

[0077] The programmable logic may be fixed, permanently or temporarily, in a tangible storage medium, such as, for example, a semiconductor memory device (e.g., RAM, ROM, PROM, EEPROM, or flash programmable RAM), a magnetic memory device (e.g., a diskette or fixed disk), an optical memory device (e.g., a CD-ROM), or other memory device. The programmable logic may be fixed in signals that can be transmitted to a computer in any form and using any of a variety of communication technologies, including, but not limited to, analog, digital, optical, wireless (e.g., Bluetooth), networking, and internetworking technologies. The programmable logic may be distributed as a removable storage medium (e.g., shrink-wrapped software) accompanied by printed or electronic documentation, preloaded with a computer system (e.g., in system ROM or fixed disk), or distributed by a communication system (e.g., the Internet or World Wide Web) from a server or electronic bulletin board.

[0078] Various examples of suitable processing modules are described in detail below. As used herein, a module refers to software, hardware, or firmware suitable for performing a particular data processing or data transmission task. Typically, in a preferred embodiment, a module refers to a software routine, program, or other memory resident application suitable for receiving, converting, routing, and processing instructions or various types of data, such as OCT scan data, IVUS scan data, interferometer signal data, target stent profile, post-stent lumen profile and image, side branch location, side branch diameter, side branch occlusion, pre-stent FFR value, post-stent FFR value, and other pre- and post-stent values, and other information of interest.

[0079] The computers and computer systems described herein may include operatively associated computer-readable media, such as memory that stores software applications used to acquire, process, store, and / or communicate data. It is understood that such memory may be internal, external, remote, or at the location of the operatively associated computer or computer system.

[0080] Memory may include any means for storing software or other instructions, such as, but not limited to, a hard disk, an optical disk, a floppy disk, a DVD (digital versatile disk), a CD (compact disk), a memory stick, flash memory, a ROM (read only memory), a RAM (random access memory), a DRAM (dynamic random access memory), a PROM (programmable ROM), an EEPROM (extended erasable programmable read only memory), and / or other similar computer readable medium.

[0081] Generally, computer-readable memory media applied in connection with the embodiments of the disclosure described herein may include any memory medium capable of storing instructions executed by a programmable device. Method steps described herein, where applicable, may be implemented or performed as instructions stored on a computer-readable memory medium. These instructions may be software embodied in various programming languages ​​(e.g., C++, C, Java, and / or various other types of software programming languages) and applicable to create instructions according to the embodiments of the disclosure.

[0082] A storage medium may be non-transient or may include non-transient elements. Thus, a non-transient storage medium or non-transient elements may include elements that are tangible, meaning that the elements have a concrete physical form, but the elements may change physical state. Thus, for example, non-transient means that such changes in state of the elements do not alter the tangible nature of the elements.

[0083] The aspects, embodiments, features, and examples of the present disclosure are to be considered in all respects as illustrative and are not intended to limit the disclosure, the scope of which is defined solely by the claims. Other embodiments, modifications, and uses will be apparent to those skilled in the art that do not depart from the spirit and scope of the claimed disclosure.

[0084] The use of headings and sections in this application is not intended to limit the disclosure, and each section may apply to any aspect, embodiment, or feature of the disclosure.

[0085] Throughout this application, wherever structures are described as having, including, or comprising particular components, or wherever methods are described as having, including, or comprising particular method steps, it is to be understood that each structure of the present teachings also consists essentially of, or consists of, the recited structures, and each method of the present teachings also consists essentially of, or consists of, the recited method steps.

[0086] Where an element or component is referred to in this application as being included in and / or selected from a list of described elements or components, it is understood that the element or component may be any of the described elements or components, or may be selected from a group consisting of two or more of the described elements or components. Further, it is understood that the elements and / or features of the compositions, devices, or methods described herein may be combined in various manners, whether expressly stated or implied herein, without departing from the spirit and scope of the present teachings.

[0087] Use of the words "include," "includes," "including," "have," "has," or "having" should be broadly understood to be open-ended and non-limiting, unless otherwise specified.

[0088] In this specification, the use of the singular includes the plural and the use of the plural includes the singular, unless otherwise specified. Furthermore, the singular forms "a", "an" and "the" include the plural, unless the context clearly contradicts otherwise. The term "about" refers to a ±10% variation from the quantitative value. Furthermore, when the term "about" is used before a quantitative value, the present teachings also include the specific quantitative value itself, unless otherwise specified.

[0089] It should be understood that the order of steps or order for performing certain actions is not important so long as the present teachings remain operable. Moreover, two or more steps or actions may be performed simultaneously.

[0090] When a range or list of values ​​is given, each intermediate value between the upper and lower limits of that range or list of values ​​is considered to be separate and is encompassed in the disclosure as if each value were specifically recited herein. Additionally, smaller ranges between and including the upper or lower limit of a given range are also considered to be within the scope of the disclosure and are encompassed. The listing of example values ​​or ranges does not exclude other values ​​or ranges between and including the upper or lower limit of a given range.

[0091] It is understood that the drawings and descriptions of the present disclosure are simplified to show elements necessary for a clear understanding of the present disclosure and omit other elements for clarity. However, as will be understood by those skilled in the art, these omitted elements and other elements may be desirable. However, because such elements are well known in the art and because they do not facilitate a better understanding of the present disclosure, a description of such elements is not provided herein. It is understood that the drawings are presented for illustrative purposes and not as structural diagrams. The omitted details, as well as modifications or alternative embodiments, are within the purview of those skilled in the art.

[0092] It will be understood that in certain aspects of the disclosure, multiple components may be substituted for single components to provide an element or structure or to perform one or more given functions, and multiple components may be substituted for single components, and such substitutions are considered to be within the scope of the disclosure unless they would not operate to practice a particular embodiment of the disclosure.

[0093] The examples presented herein are intended to illustrate possible or specific implementations of the present disclosure. It will be understood that the examples are primarily intended to illustrate the present disclosure to those skilled in the art. There may be variations in these figures or operations described herein that do not depart from the spirit of the present disclosure. For example, in some cases, method steps or operations may be performed or executed in a different order, or operations may be added, deleted, or modified.

[0094] [Appendix 1] 1. A method for assessing stent deployment in a blood vessel, comprising: generating, using one or more computing devices, a representation of a segment of the vessel using a first endovascular data set acquired for the vessel; receiving a selection of a first criterion relative to the representation of a segment of a blood vessel; receiving a selection of a second criterion relative to the representation of the vessel segment; generating, using one or more computing devices, a target stent profile based on the first criterion and the second criterion; generating, using one or more computing devices, a vessel lumen contour following deployment of a stent within the vessel; comparing the target stent contour to one or more regions of the vessel lumen contour; generating an output using a user interface, the output including one or more differences resulting from comparing the target stent profile to the one or more regions; The method includes: [Appendix 2] 2. The method of claim 1, further comprising displaying an indicator of side branch occlusion based on one or more side branches not detected when comparing the target stent contour to one or more regions of the vascular lumen contour. [Appendix 3] 2. The method of claim 1, wherein the one or more outputs are a visual representation of the target stent contour overlapping one or more regions of the vascular lumen contour. [Appendix 4] 2. The method of claim 1, wherein the one or more outputs are comparative metrics of changes in parameters measured or calculated relative to the segment of the blood vessel. [Appendix 5] 5. The method of claim 4, wherein the parameter is selected from the group consisting of fractional flow reserve, flow rate, vascular resistance ratio, virtual fractional flow reserve, simulated fractional flow reserve, measured fractional flow reserve, and pressure measurements. [Appendix 6] 2. The method of claim 1, wherein using one or more computing devices to generate a vessel lumen outline after deploying a stent within the vessel includes generating a representation of a segment of the vessel using a second endovascular data set acquired for the vessel. [Appendix 7] 7. The method of claim 6, wherein the first intravascular data set is acquired during a first optical coherence tomography imaging session. [Appendix 8] 7. The method of claim 6, wherein the first intravascular data set is acquired during a first intravascular ultrasound imaging session. [Appendix 9] 2. The method of claim 1, wherein the step of generating an output includes the step of displaying one or more outputs representing a correlation or goodness of fit between the target stent contour and the one or more regions of the vascular lumen contour. [Appendix 10] The method of claim 1, further comprising the step of generating and displaying a difference between the post-stent lumen contour and the pre-stent target contour, or generating and displaying a value correlated with the difference per frame or per segment. [Appendix 11] 2. The method of claim 1, further comprising detecting one or more side branches within the blood vessel. [Appendix 12] 12. The method of claim 11, further comprising adjusting the shape of the target stent profile for each side branch. [Appendix 13] 13. The method of claim 12, wherein the step of adjusting the shape includes stepping up the stent geometry each time a side branch is detected when a distal reference diameter is smaller than the proximal reference diameter. [Appendix 14] 13. The method of claim 12, wherein the step of adjusting the shape includes stepping down the stent geometry each time a side branch is detected if a distal reference diameter is greater than the proximal reference diameter. [Appendix 15] 1. An automated processor-based system for assessing stent deployment in a blood vessel, comprising: one or more memory devices; a computing device in communication with the memory device, the memory device comprising instructions executable by the computing device, the instructions comprising: generating a target stent profile in response to one or more user selections from a user interface, the user interface displaying a first representation of the vessel, the user selections including a proximal datum and a first datum; generating a second representation of the vessel after stent deployment and displaying the second representation; displaying one or more parameters relative to the second representation of the vessel, the one or more parameters indicative of under- or over-expansion of the deployed stent. system. [Appendix 16] 16. The system of claim 15, wherein the instructions executable by the computing device cause the computing device to perform the step of displaying side branch occlusion. [Appendix 17] 16. The system of claim 15, wherein the instructions executable by the computing device cause the computing device to perform the step of displaying a target stent profile. [Appendix 18] 20. The system of claim 17, wherein the instructions executable by the computing device cause the computing device to adjust a shape of the target stent profile for each side branch. [Appendix 19] 16. The system of claim 15, wherein the instructions executable by the computing device cause the computing device to perform the step of overlaying the target stent contour onto a lumen contour. [Appendix 20] 16. The system of claim 15, wherein the instructions executable by the computing device cause the computing device to display measured FFR or VRR values ​​after deployment of steps.

Claims

[Claim 1] 1. A method for assessing stent deployment in a blood vessel, comprising: generating, using one or more computing devices, a representation of a segment of the vessel using a first endovascular data set acquired for the vessel; receiving a selection of a first criterion relative to the representation of a segment of a blood vessel; receiving a selection of a second criterion relative to the representation of a segment of a blood vessel; generating, using one or more computing devices, a target stent profile based on the first criteria and the second criteria; generating, using one or more computing devices, a vessel lumen contour after deployment of a stent within the vessel; comparing the target stent contour to one or more regions of the vessel lumen contour; The method includes:

Images