Intravascular data acquisition and processing system

Abstract

To visualize a stent deployment against a blood vessel wall by using an angiography system and to determine a stent position on a base for each image.SOLUTION: The disclosure relates to an intravascular data collection system and an angiography system, data exchange between the former two or more systems, and generation and display of diagnostic information such as an indicator. One or more indicators may be generated and displayed by overlaying an image generated by using, for example, the intravascular data collection system and such an indicator or by combining them in another method. The indicator may include a longitudinal direction or vertical direction, a horizontal direction or other kinds of indicator such as one or more indicators or graphical elements suited for indicating diagnostic information of interest. The indicator may be used to guide a user during a stent delivery planning and other operations.SELECTED DRAWING: Figure 1

Description

[Technical field]

[0001] [Related Applications] This application is a continuation of U.S. Provisional Patent Application No. 62 / 162,795, filed May 17, 2015. No. 62 / 196,997, filed June 25, 2015; and Priority claim to U.S. Patent Application No. 14 / 975,516, filed December 18, 2015. and claims the benefit of the same, the disclosures of which are incorporated herein by reference in their entireties.

[0002] The present disclosure relates generally to intravascular measurement and feature detection and related diagnostic methods and devices. [Background technology]

[0003] Coronary artery disease is one of the leading causes of death worldwide. The ability to see and treat can be of life-saving importance. Optical Coherence Tomography (OCT) uses light to peer into the walls of the coronary arteries and capture images for examination. Coherent light, interferometry is a catheter-based imaging modality that produces Utilizing micro-optics, OCT allows for video-rate in vivo sectioning of diseased blood vessels. It can provide layer imaging with micrometer-level resolution. Fiber Optic Probe High resolution visualization of subsurface structures using the CT scanner allows for minimally invasive imaging of internal tissues and organs. This level of imaging possible with OCT makes OCT particularly useful. The details will enable clinicians to not only monitor the progression of coronary artery disease, but also diagnose it. OCT images provide high-resolution visualization of coronary artery morphology and are useful for diagnostic and stent delivery planning. alone or in conjunction with other information such as angiographic data to aid in planning of the imaging procedure, etc. It can be used in combination with other sources of data.

[0004] OCT imaging of parts of a patient's body provides a useful diagnostic tool for doctors and others. For example, imaging of coronary arteries with intravascular OCT reveals the location of narrowing or stenosis. This information is used by cardiologists to determine whether invasive coronary artery bypass surgery and Less invasive catheter procedures such as angioplasty or stent delivery It helps patients choose between chemotherapy and chemotherapy-based treatments. Tent delivery has its own associated risks.

[0005] A stent is a tubular structure, often made of mesh. It blocks blood flow. It can be inserted into a vessel and expanded to address a restrictive stenosis. The catheter is typically made of a metal or polymer scaffold. During cardiovascular procedures, stents can be deployed to the site of a stenosis via a catheter. The catheter is delivered to the site of the stenosis via a guidewire and a balloon is used. Typically, a stent is used to widen the lumen of a narrowed blood vessel. The angiography system uses a preset pressure to expand the The stent device, intravascular ultrasound system, and OCT system are used in combination or alone. It can be used to facilitate remediation planning and stent deployment.

[0006] There are several factors that influence patient outcomes when deploying a stent. In this procedure, the stent is expanded to a diameter that corresponds to the diameter of the adjacent healthy vessel segment. Overexpansion of the stent can cause severe damage to the blood vessel and lead to dissection. tion, disarticulation, and intramural hemorrhage. Insufficient expansion of the stent may cause the vessel to expand inappropriately. Failure to do so may increase the risk of thrombosis. A poorly apposed stent may not be able to restore normal flow. Once the stent is placed, stent malapposition and stent replacement are possible. Insufficient expansion of the network may result in a variety of problems.

[0007] There are other challenges associated with stent placement and related procedures. Visualization of stent deployment against the vessel wall is difficult to achieve by inspection. Additionally, angiographic images were manually reviewed to determine stent position on an image-by-image basis. Doing so is also error-prone.

[0008] The present disclosure addresses these and other issues. Summary of the Invention [Means for solving the problem]

[0009] In part, the present disclosure provides a method for determining whether a stent is in a stent delivery path or for other purposes. Vascular imaging, such as OCT and / or IVUS, that may be used to generate and display cross-sectional information. The present disclosure also relates to imaging and intravascular data collection systems. , and their integration into the display of image data. Longitudinal indicators such as the endoscopic position bar are useful in diagnostic processes such as stent planning. For this purpose, alone or in combination with a stent strut indicator used in conjunction with a set of OCT scan lines or On angiographic frames that are co-registered with an image-like endovascular dataset may be overlaid on

[0010] In part, the present disclosure provides a method for a user of an intravascular data collection system, and in one embodiment, In this embodiment, the results of data analysis applied to an intravascular data set are displayed on an angiography system. In part, this disclosure relates to a system and method for displaying areas of stent apposition. and other regions of interest can be found and understood on OCT and angiography images. A user interface and one or more generated Graphical data representations that can be applied to images of blood vessels or angiographic images ) to provide a graphical user interface (GUI).

[0011] In part, this disclosure relates to a cath lab system, such as an optical coherence tomography system. ) related to a data acquisition system, such as an intravascular data acquisition system, suitable for use in In part, this disclosure relates to a device including a processor adapted to display intravascular image data. The displayed image data is generated based on the depth measurement. In one embodiment, the image data includes optical coherence tomography data. The system also generates a stent for one or more stents in a blood vessel. on stent malapposition in the longitudinal mode on a stent strut-by-stent strut basis. Data such as, or of potential interest, stented, unstented, or stented apposition A user interface for displaying intravascular information, such as a bar with areas corresponding to levels. The face may be displayed.

[0012] The one or more indicators, such as the longitudinal indicator, may include, but are not limited to, By way of example, it may be generated in response to a stent detection process and lumen border detection, angiography, OCT and IVUS images may be displayed. These are useful for planning stent delivery. and coregistering OCT and angiographic images for relevant indications of interest. To expand or adjust stent delivery by reviewing with the In part, the system described herein may be viewed by a user for the purpose of and the method identifies areas of missing data by hashing, coloring areas, or other visual indicators. By replacing it with an indicator like In this way, the end user can easily see the black areas as shadows or side branches. Instead of misinterpreting it, you are notified when data is missing. The data region may be determined based on whether the region is a side branch, a stent, or other feature of interest to the diagnostician. The information is coded with an indicator that prevents it from being misinterpreted. The method further comprises displaying indicia of the stent struts on a graphical user interface. and displaying one or more of the intravascular images for which data was unavailable for display. In one embodiment, the method further comprises the step of displaying an indicia indicating the above area. The apposition bar is independent of the intravascular view and therefore serves as an indicator or spot. It is displayed just like the juxtaposition bar is displayed when there is no image containing a tent. In one embodiment, the present disclosure provides a method for aligning a stented region. The stented area is located with the apposition bars aligned. The stent struts are supported by a support bar, and the apposition bars are rotationally agnostic or It is continuous.

[0013] In part, the present disclosure relates to, for example, an optical coherence tomography probe or an intravascular ultrasound probe. In the context of an intravascular data set acquired using a probe such as a stent, detection and shadow detection.

[0014] In part, the present disclosure provides a method for detecting metal stent struts in a shadow cast in OCT image data. The present invention relates to a system and method for accurately determining the offset or location of a stent. The method of tratt detection includes the steps of accessing multiple frames of intravascular imaging data ( accessing), where multiple frames are scanned using optical coherency tomography (OCT) scan lines. Including, steps, and influence areas corresponding to candidate stent struts A step of identifying a candidate strut shadow scan line. Identifying scan lines corresponding to candidate stent strut shadow regions, and and analyzing the shadow scan lines to identify the location of the stent struts. That's fine.

[0015] The method of stent strut detection also involves storing multiple frames of intravascular imaging data. storing a stent within a first group of frames of the plurality of frames; detecting struts, one or more shadow regions in the first group of frames; and detecting one or more of the shadow regions as detected stent segments. adjacent to the trough, the step, the area where the given shadow area is due to the guidewire or the side branch The candidate stent strut shadow areas were then determined on a shadow area by shadow area basis. generating a set of candidate stent strut shadow regions, each of the candidate stent strut shadow regions including a shadow boundary; , step, and scanning lines to identify candidate stent strut shadow regions within the shadow boundary. The method may include the steps of:

[0016] The methods of the invention may include additional steps or features. For example, the methods may include non-step The candidate stent straps are identified by eliminating the shadow regions corresponding to the stent features. The non-stent feature may include, for example, identifying a shadow region corresponding to a guide It may be selected from the group consisting of a wire, a side branch, and combinations thereof.

[0017] The method excludes candidate strut shadow scan lines that contain spillage from lumen pixels. The method may include the step of summing the signal responses over the candidate strut shadow scan lines. By doing so, each of the candidate strut shadow scan lines or a portion or sample of a scan line is The method may include the sub-step of determining a projection over The method may include the sub-step of identifying up to three maxima in

[0018] The method ranks the maxima based on peak signal strength and calculates the peak score. The step of ranking may include the substep of generating a ranking list. The ordinal order is shown in Fig. 1. The maxima with higher peak signal strength receive higher peak scores. ) may be a ranking.

[0019] The method ranks the maxima based on their proximity to the vessel wall and calculates a proximity scale. The step of ranking may include a sub-step of generating cores. There may be an ordinal ranking, with maxima closer to the wall receiving higher proximity scores. The method may include the step of assigning a malapposition score to each local maximum. Scores may be binary, with poorly aligned maxima receiving a score of zero. You may accept it.

[0020] The method includes summing the peak score, the proximity score, and the non-perfect contact score. The local maximum with the highest total score may be designated as the location of the stent strut. can be.

[0021] The method includes the steps of identifying a plurality of shadow regions corresponding to candidate stent struts; Identifying scan lines corresponding to stent strut shadow regions and and identifying the location of the stent strut within the strut shadow region. The method performs a cross-frame analysis to identify multiple optical coherences. The designated stent struts were aligned across the optical computed tomography (OCT) imaging frames. A step of validating may also be included.

[0022] The method includes displaying the identified stent struts on a graphical user interface. The present disclosure may also include a step of causing a processor to execute the steps of: The present invention includes a computer-readable medium including non-transitory instructions for causing a computer to perform any one of the following:

[0023] However, the present invention relates to different aspects and embodiments, and is not limited to those disclosed herein. The different aspects and embodiments may be combined in whole or in part as appropriate. It is understood that the embodiments disclosed herein may be combined. In addition, some of the Aspects and embodiments are described using the term "means for," but as used herein All aspects, embodiments and other concepts disclosed herein are intended to be illustrative and not restrictive, even if specific "means" language is used in the writing. Means-plus-function claims are not used in any specific part of the description. It is understood that the present invention may serve as a support for the [Brief description of the drawings]

[0024] The drawings are not necessarily to scale, emphasis instead being placed generally on illustrative principles. The drawings are to be considered in all respects illustrative and not restrictive as to the disclosure. No such disclosure is intended, the scope of which is defined only by the claims.

[0025] [Figure 1] FIG. 1 shows a schematic diagram of an intravascular imaging and data collection system according to one exemplary embodiment of the present disclosure.

[0026] [Figure 2A] 2A-2E show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators, as well as an angiography system, for diagnostic processes including stent delivery planning, according to one exemplary embodiment of the present disclosure. [Figure 2B] 2A-2E show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators, as well as an angiography system, for diagnostic processes including stent delivery planning, according to one exemplary embodiment of the present disclosure. [Figure 2C] 2A-2E show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators, as well as an angiography system, for diagnostic processes including stent delivery planning, according to one exemplary embodiment of the present disclosure. [Figure 2D] 2A-2E show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators, as well as an angiography system, for diagnostic processes including stent delivery planning, according to one exemplary embodiment of the present disclosure. [Figure 2E] 2A-2E show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators, as well as an angiography system, for diagnostic processes including stent delivery planning, according to one exemplary embodiment of the present disclosure.

[0027] [Figure 3A]3A-6 show various user interfaces and data representations, including various indicia and co-described features, relating to one or more imaging modalities, according to one exemplary embodiment of the present disclosure. [Figure 3B] 3A-6 show various user interfaces and data representations, including various indicia and co-described features, relating to one or more imaging modalities, according to one exemplary embodiment of the present disclosure. [Figure 4A] 3A-6 show various user interfaces and data representations, including various indicia and co-described features, relating to one or more imaging modalities, according to one exemplary embodiment of the present disclosure. [Figure 4B] 3A-6 show various user interfaces and data representations, including various indicia and co-described features, relating to one or more imaging modalities, according to one exemplary embodiment of the present disclosure. [Diagram 5] 3A-6 show various user interfaces and data representations, including various indicia and co-described features, relating to one or more imaging modalities, according to one exemplary embodiment of the present disclosure. [Figure 6] 3A-6 show various user interfaces and data representations, including various indicia and co-described features, relating to one or more imaging modalities, according to one exemplary embodiment of the present disclosure.

[0028] [Figure 7A] 7A and 7B show a three-dimensional representation of side branch markings generated using intravascular imaging data, such as OCT data, according to one exemplary embodiment of the present disclosure. [Figure 7B] 7A and 7B show a three-dimensional representation of side branch markings generated using intravascular imaging data, such as OCT data, according to one exemplary embodiment of the present disclosure.

[0029] [Figure 8A]8A-9B show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators for a diagnostic process, and an angiography system, according to one exemplary embodiment of the present disclosure. [Figure 8B] 8A-9B show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators for a diagnostic process, and an angiography system, according to one exemplary embodiment of the present disclosure. [Figure 9A] 8A-9B show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators for a diagnostic process, and an angiography system, according to one exemplary embodiment of the present disclosure. [Figure 9B] 8A-9B show additional details regarding a user interface display and an intravascular data collection system and appropriate indicators for a diagnostic process, and an angiography system, according to one exemplary embodiment of the present disclosure.

[0030] [Figure 10A] FIG. 10A illustrates an exemplary intravascular data collection system and associated intravascular data collection probe, as well as associated image processing, detection and other software components, according to an exemplary embodiment of the present disclosure.

[0031] [Figure 10B] FIG. 10B is a cross-sectional OCT image of a stented vessel according to one exemplary embodiment of the present disclosure.

[0032] [Figure 11] FIG. 11 is a process flow diagram for detecting struts in OCT image data according to an exemplary embodiment of the present disclosure.

[0033] [Figure 12]FIG. 12 is a scan line OCT image of a stented vessel in polar coordinates and logarithmic scale according to one exemplary embodiment of the present disclosure.

[0034] [Figure 13] FIG. 13 is a graph illustrating detection of multiple potential struts in a single shadow according to an exemplary embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0035] In part, this disclosure relates to intravascular data acquisition systems, such as OCT, IVUS, and vascular imaging systems, and exchange of data between two or more of the foregoing, and, for example, In one embodiment, the OCT method is directed to generating and displaying diagnostic information such as an indicator. Such intravascular data is collected while angiographic data is being simultaneously acquired. An indicator is one or more one- or two-dimensional graphic elements and the control of color, gray, - Scales or scale gradations, hashes, symbols or other The device may include one or more associated indicia, such as a visual element.

[0036] The one or more indicators may be generated, for example, using an intravascular data acquisition system. You may overlay or otherwise combine such indicators with the images provided. The indicators may be generated and displayed by: Tracking of user selected landmarks, etc. A long, sharp object, such as one or more indicia or graphical elements suitable for indicating Includes longitudinal, transverse and other indicator types Stent strut indicators may also be used. A method for detecting such intravascular features is described herein, which allows a user to - To display in the interface and to overwrite indicators or markings thereon The angiographic data may also be used to display co-registered (co-registered) may be integrated and displayed with various common indicators as part of a "istered" display. In one embodiment, shadows that may be misinterpreted as dissections, side branches, or other vascular features are and other elements distinguish them and allow the use of image frames and data according to one embodiment. may be shaded or otherwise altered to facilitate review and analysis. Good too.

[0037] Appropriate diagnostic information includes malapposition of the stent to the vessel wall or luminal border. n), user-selected OCT placement within the vessel and associated angiography frame position, as well as other Such as endovascular diagnostic information or other information generated to facilitate stent delivery planning. Such information may include stent apposition information. It communicates with the graphical user interface and The one or more processors are configured to send instructions to the interface. The software program may be used to perform one or more of the following: Co-registering data such as image data, and stent placement relative to the determined lumen boundary. generating and displaying a longitudinal indicator showing the position of the device; To code or label missing regions, one or more Graphical elements are used to display user-selected OCT placement information on the angiogram display. and visualizing the stent and simulated stent for planning purposes. and as otherwise described herein.

[0038] In part, the present disclosure relates to imaging data or other endovascular measurements taken on a subject. A graphical user interface is displayed on the display that represents the data of interest, such as parameters. - Interface (GUI) elements or indicators. Optical Coherence Tomography Pullback recording or IVUS or other intravascular or angiographic systems Any clinically useful parameters that change longitudinally or transversely during the process may be included in the Each indicator / mark may be manually evaluated and displayed as an indicator or mark. Clinical review of the entire pullback recording in a single view without the need to manipulate the It may also be used by interventional cardiologists to quickly view clinically useful information. Indicators are based on parameters exceeding or falling below clinically meaningful thresholds. The device may guide the user to a particular point of interest within the blood vessel by, for example, marking the appropriate By using a continuous color map or other scale to encode parameter values. Thus, the varying degrees of stringency of the parameters can be displayed across the vessel in one easy-to-interpret view. These features can be easily summarized as follows: is shown with other indicators for angiographic images and other intravascular data acquisition images. do.

[0039] FIG. 1 includes a system suitable for implementing some of these features. The top right panel shows the first user-selected configuration US1, the second user-selected configuration US2, and the third user-selected configuration US3. Angiographic display with various indicators including US2 and active frame AF These indicators are also shown on the bottom L-mode or longitudinal panel. US1 and US2 correspond to the vertical lines shown, and the Active Frame AF corresponds to the vertical line between them. The active frame is shown in cross section in the top right panel. The middle panel shows the values ​​in millimeters of US1 and US2 placement relative to the vessel placement. The calculated MLA is shown in Fig. 2B together with the OCT data of Fig. 1. 2 shows an enlarged view of the angiographic image of FIG. 1. These user interfaces are may be controlled by a user using a mouse, joystick or other control device. and can be operated using one or more processors and memory storage elements. The movable elements C1 and C2 are control devices and can be controlled by an interface. They can also be rotated or moved as part of the interface. 3B and others. In FIG. 3B, the control devices C1 and C2 also It is represented as a semicircle for the rat and as a line segment in the right panel.

[0040] FIG. 2C illustrates a juxtaposed bar / indicator bar 111 having regions R1 through R7. These are shown in the upper right angiographic view in more detail in FIG. 2D. The top right panel shows R3, which indicates the area of ​​apposition above the threshold of interest. In the present invention, the stent struts are coded using indicia such as symbols or colors. The area of ​​apposition of interest in the placement bar may be important for stent planning and patient evaluation. Even if the data set is rotated to draw the user's attention to the relevant area, the display In this sense, the indicator remains on the screen to direct the user's focus during planning or other procedures. FIG. 2E shows an exemplary juxtaposition bar or indicator. Additional details regarding the bar 111 are shown. The indicator bar 111 is used to guide the planning and placement of the stent. It may be used for review and review, and may be placed apposed to the stent struts or on a separate medial The indicator bar may be used to indicate areas of the intravascular image where tricks are present. 111, in one embodiment, the view selected by the user - 3D, cross-sectional , alerting the user to the stent area even if it is not visible based on longitudinal orientation, viewing angle, etc. To give it a persistent user interface view.

[0041] With reference to FIG. 2C, two user-selected points of interest are shown as U1 and U2. R3 corresponds to the area of ​​malapposition of interest. R2 corresponds to the first stent. R6 corresponds to the second stent. R5 is the gap between them. To facilitate tent planning, the angiographic data are coregistered as shown in FIG. 2D. The data collection elements of the probe DC are shown in the image. R1 and R7 are the points where the stent is located. U1 and U2 are the distal and proximal segments that are absent and correspond to the vessel lumen. To provide a frame of reference for the vessel segments labeled with U2, It can be used by the user watching a live angio. One or more displays may be used to display, for example, , live angiograms and OCT pullback data with previously acquired pullback frames. It may be used as a

[0042] Using these and other indicators, the images and indicators are shown in Figs. 2C and 2D. The presented data can serve as a tool to guide stent delivery. Indicators may also be color coded or otherwise coded in cross-section or longitudinal section. Given the markings of the coded stent struts, the stent must be expanded. In FIG. 2E, the first stent 222a and the second stent 222b are shown in more detail. The area of ​​the stent 222b is indicated by the apposition bars 111. Areas 224 and non-contact areas 223 are also shown. The image may be displayed on any angiographic, OCT or IVUS image. In morphology, the apposition bar is independent or continuous with respect to the intravascular view. so that the apposition bar is not present when an image including an indicator or stent is not present. The various indicators and markings are as shown in Figs. The system was used to generate stent detection, lumen detection, stent apposition measurement, and various The image may be generated based on a graphic overlay.

[0043] FIG. 3A shows the interface along with the longitudinal section or L-mode and the apposition threshold based 4 shows the apposition bars above the stent strut indicators coded with Tabor 111, with stent-free areas 224 and areas of malapposition 223 shown. The luminal boundary data from OCT or IVUS is shown in the center of the GUI. Juxtaposition issues such as threshold violations in the strut data collected are identified by the Juxtaposition Bar Generator. The input to the synthesis software module is used to determine the The interface screen is shown in the GUI screenshot L-mode display. High levels of apposition were measured for the metal stent struts as shown on the plot. 1 illustrates one example of an indicator that allows for manual manipulation of image data. Allows summary information on clinical parameters to be displayed without the need for testing or examination. The stent apposition bars and other indicators shown herein and their blood Co-registration with ductography offers many advantages to the user.

[0044] 3A, 3B, 4A and 4B, some of the user interfaces are Embodiments provide a method for displaying stent strut apposition and other indicator-based data Intravascular and angiographic data (if applicable) along with one exemplary indicator In one embodiment, the apposition bar depicts L-mode and angiographic images, 3D The original flow image and others are shown above. Figure 4B shows the threshold information along the outer boundary of the vessel. A longitudinal cross-sectional view of the apposition bar 111 is shown together with an angiogram image with the stent data. Region 161a in the angiography portion of the user interface is also indicated by indicator bar 111. In one embodiment, the angiographic image is aligned with the region 161b of the apposition bar. The juxtaposition bars 111 are aligned or registered with each other. One feature is that it is persistent in the user interface, so Stents are present in the 2D or 3D images but may not appear based on the cut plane or viewing angle. If not, the apposition bar will persist and no 2D or 3D stents will appear in the GUI. This indicates the presence of a stent and any associated malapposition. This may affect stent planning and This is a useful feature for diagnosis.

[0045] In FIG. 4A, indicators showing the stent struts and apposition area of ​​interest 157 are shown. Tabs 111 are shown. These areas of interest 157 showing apposition are The struts may be grouped together with their own representation and color coded or displayed in the GUI. The markings and indicator bars may be coded with other markings that can be seen on the screen. One example of grouping of torso strut cords is shown in Figs. 3A, 3B, 5 and 6. In these regions 188, the indicator bar 11 FIG. 1 shows a schematic diagram of a stent and a series of struts along with various markings corresponding to their apposition to the vessel wall. The detected lumen boundary is shown aligned with the display. Additional details regarding stent detection are included herein. do.

[0046] Figure 5 shows the missing data such as unclear data or data with missing guidewire shadow. The data is then modified in software to replace it with a grey mask or other indicator. Other GUIs are shown, along with indicators or image data processing features. To avoid confusion with missing data, the indicator MD is used This is used to indicate areas where the user is missing data, incision areas, In one embodiment, the method has the advantage of preventing mistakes about the side branch. Areas where data are missing as a result of shading or for other reasons are marked as grey areas. displayed using marks or indicators such as marked areas, hashing or other visible marks. The central double-headed arrow icon allows the view to be rotated. User control of the guidewire by apposition bars and color coding or other markings image data from an intravascular data collection probe and / or angiographic data, along with identification of Completely improve and expand the diagnostic scope of

[0047] In another embodiment, as shown in FIG. In one embodiment, the indicator W is used to indicate It may be used to identify the guidewire or to select and remove it from the image. FIG. 6 shows a 3D fly-through, with the alignment bar pointing to the user's view corresponding to the cross-section on the right. 3D fly-through view and region of interest Indicators showing stent struts and apposition areas of interest included in any other view of the The Catalog Bar 111 rotates to alert the user to critical vascular areas during stent planning. can still be seen inside.

[0048] 7A and 7B show another indicator SB corresponding to a side branch. These and other indicators are also The data may be used to highlight regions of the 2D and 3D data. As shown in the user interface depicted in the figure, the various circles in the top right view / The line segments C1, C2 are rotated to navigate through various views of the image 8A-9B show a method for navigating the image data set and for stent planning. It shows additional interface and control information for performing diagnostics such as diagnostics. The proximal and distal views, as well as other perspective views, can be navigated using the tools provided herein. In one or more embodiments, an insulator such as juxtaposed bars 111 may be gated. The indicator is persistent so that even if you navigate away from the area of ​​poor contact, Even if the view is overwritten, they remain in view.

[0049] Thus, some indicators are rotationally agnostic and therefore If the indicator contains a region or length that contains a parameter that exceeds the threshold, then The rotated view may obscure areas such as poorly apposed stent regions. Even if the image data is changed in this way, the area will still show itself. Therefore, if one side of the vessel has an apposition problem, the user must be aware of their location within the vessel. The apposition bar is displayed on the angiogram or OCT image or on the user's - displayed as an indicator in one or more views of the interface This is also fine.

[0050] As shown in the various figures, the apposition bars 111 may be used to accommodate the presence of a stent or other suitable means within the vessel. Presence or malposition of multiple stents or vessels with multiple stents The angiogram data may be subdivided into various regions or lengths showing the gaps between the stents. The data and associated image frames may be co-registered with the OCT data. A user-selected vertical line corresponding to a particular longitudinal distance on the artery is displayed on the Rotationally agnostic or persistent The nature of the bars provides additional assistance and error reduction during stent planning.

[0051] During the stent delivery planning procedure, clinician-specified landmarks are used to guide the user to the stent site. By providing a stent size selection and a vascular reference, The device may be used to deploy a stent using live angiography. The level and location of the malapposition can be given. This allows users to refer to OCT and annotated angiograms to improve delivery planning. The features and methods of these systems include: For example, this may be implemented using system 3 shown in FIG. 1 and the system of FIG. 10A. .

[0052] FIG. 1 illustrates a system for collecting data or detecting a characteristic or sensing a condition of an object 4. Various data acquisition subsystems suitable for measuring or otherwise diagnosing subject 4. In one embodiment, the subject is able to move from a table, bed, to a chair. or other suitable support. Typically, the subject 4 is , a human or other animal having a particular region of interest 25.

[0053] The data acquisition system 3 may be a nuclear magnetic resonance, x-ray, computer-aided tomography, or other suitable This includes non-invasive imaging systems such as non-invasive imaging techniques. As one non-limiting example of a system, to generate cines A suitable angiography system 21 is shown. The angiography system 21 may be a fluoroscopy system. The angiography system 21 may include, for example, an imaging system such as OCT or IVUS. In one or more imaging techniques, angiography is used to depict blood vessels within a region 25 of a subject 4. Typically, while a pullback procedure is being performed using the probe 30 to be imaged, non-invasively such that frames of angiographic data are generated in the form of frames of image data. Configured to image subject 4.

[0054] The angiography system 21 is in communication with an angiography data storage and image management system 22. It may be implemented as a workstation or a server in one embodiment. In one embodiment, data processing on the collected angiographic signals includes: The image from the system 21 is then processed directly on the detector of the angiography system 21. The images are stored and managed by the data storage and image management unit 22.

[0055] In one embodiment, the system server 50 or the workstation 87 is In one embodiment, the entire system 21 handles the functions of detecting electromagnetic radiation, such as x-rays. The system 21 also receives such radiation after it has passed through the subject 4. The data processing system 22 then uses the signals from the angiography system 21 to The system images one or more regions, including region 25 of FIG. As described in the present application, the intravascular data and various indicators and detected stenoses are Angiographic data is shown on displays 82 and 82 along with the streaks and shadows. This makes it possible.

[0056] As shown in this particular example, the region of interest 25 may be the vasculature, such as a particular blood vessel, or the periphery. A subset of the vasculature. It can be imaged using OCT. A thermocouple-based data collection probe 30 is introduced into the subject 4 and measures a particular The probe 30 is placed in the lumen of a certain blood vessel. a probe combining two or more of the features of the preceding; and other probes suitable for intravascular imaging. The probe 30 typically includes a probe tip, one or more radioactive The probe tip includes an opaque marker, an optical fiber, and a torque wire. Optical beam directors, acoustic beam directors, pressure detector sensors, other transducers or detectors , and combinations of the foregoing.

[0057] For intravascular probes that include an optical beam director, the optical fiber 33 is The torque wire is a fiber optic cable that is connected to the probe. In FIG. 1, the optical fiber 33 is shown without a torque wire surrounding it. In addition, the probe 30 may also be a polymeric sheet that forms part of the catheter. In the context of an OCT system, the interferometer sample includes a sheath such as a scabbard (not shown). The optical fiber 33, which is part of the catheter arm, is connected to the patient interface unit as shown. The optical fiber optic cable is optically coupled to a PIU 35 .

[0058] The patient interface unit 35 receives the end of the probe 30 and optically connects it to Typically, the data collection probe includes a probe connector adapted to be coupled to a The PIU 35 is configured to accommodate the type of data collection probe being used. Includes appropriate joints and elements based on, for example, OCT and IVUS data acquisition The probe combination requires OCT and IVUS PIU. PIU35 is a typical In effect, the torque wire, the sheath, and the optical fiber 33 disposed therein are pulled back during the procedure. In addition to being retracted, the probe tip also includes a motor suitable for retracting the probe tip. The end is also typically rotated by the PIU 35. In this manner, the object 4 The blood vessels may be imaged longitudinally or through a cross-section. The probe 30 may also be used to measure FFR or may be used to measure specific parameters such as pressure measurements. The data may be used to generate various 2D and 3D views, which may be , may be navigated as shown in the depiction of the user interface.

[0059] The PIU 35 is then connected to one or more intravascular data acquisition systems 42. The intravascular data acquisition system 42 may be an OCT system, an IVUS system, or any other imaging system. For example, a probe that is an OCT probe. The system 42 in the context of the beam 30 includes a sample arm of an interferometer, a reference arm of an interferometer ( reference arm, photodiode, control system, and patient interface unit. Similarly, in the context of an IVUS system, as another example, intravascular data may be included. The acquisition system 42 includes ultrasonic signal generation and processing circuitry, noise filters, a rotatable joystick, In one embodiment, the device may include a power supply, a motor, and an interface unit. The data acquisition system 42 and the angiography system 21 are connected to an angiography video frame time stamp. A shared time stamp is configured to synchronize the time stamps of the OCT images and the frame time stamps of the OCT images. The clock or other timing signal may include:

[0060] In addition to the invasive and non-invasive image data collection systems and devices of FIG. and various other types of data may be collected regarding other parameters of interest of the subject. For example, the data collection probe 30 may include one or more The pressure wire may include a pressure sensor such as an OCT or ultrasound component. Pressure readings may be taken along a segment of a blood vessel within region 25 of subject 4. This may also be the case.

[0061] Such reading may be by either a wired connection or via a wireless connection. Fractional Flow Reserve (FFR) Data Acquisition System As shown in FIG. 1, a wireless transceiver 48 receives pressure readings from the probe 30. , and transmit them to the system to obtain FFR measurements or more measured positions along the vessel. The one or more displays 82, 83 are also configured to generate , angiography frames of data, OCT frames, user interfaces for OCT and angiography data User interface, shadows, indicators, missing data and other controls and features of interest It may be used to indicate a symptom.

[0062] endovascular data such as frames of endovascular data generated using the data collection probe 30 Imaging data is acquired by a data acquisition and processing system coupled to the probe via a PIU 35. 42 along the route. The invasive image data is stored on a co-registration server 50 and a workstation 87. transmitted to and stored in one or more servers or workstations, such as The angiographic image data may be acquired from the system 22. A video frame grabber device 55, such as a configured computer board, may be implemented in various ways. It may be used in the form.

[0063] In one embodiment, the server 50 includes a processor 80 that is operable to process the The server 5 includes one or more co-written software modules 60 executed by the 0 is another typical component for a processor-based computing server. Alternatively, more databases such as database 90 may be generated. The collected image data, subject parameters, and one or more of the systems shown in FIG. The data may be generated by a system device or component and received or may be configured to receive other information that is transferred to database 90. The base 90 is stored in memory at the workstation 87 and Although shown connected to server 50, this is only one exemplary configuration. For example, the software module 60 may be implemented by a processor in a workstation 87. The database 90 may be located in the memory of the server 50. An apparatus or system for operating various software modules may be, for example, The hardware and software described herein in various combinations are provided. The software obtains frames of image data, processes such image data, and It may be used to register such image data.

[0064] As noted elsewhere herein, software module 60 may include preprocessing Processing software, conversion, matrix, lumen detection, stent detection, shadow detection, indicator Generators and displays and other software-based components 60 To facilitate the co-description of different types of image data by, or otherwise to facilitate such co-description The imaging data may be used to process the image data or to respond to a patient trigger to perform the procedure. may include software such as other software-based components. The module uses scan line based or image based techniques. Lumen detection, stent detection using scan-line-based or image-based techniques, indicator generation Prevent confusion with juxtaposition bar generation, incision, side branch and missing data for stent planning The device may also include a guidewire shadow indicator, etc.

[0065] The database 90 is generated by the angiography system 21 and is imaged by the frame grabber 55. Receives and stores angiographic image data 92, such as image data acquired by server 50. The database 90 may be generated by the OCT system 42. The OCT image data is acquired by the frame grabber 55 server 50. It may be configured to receive and store image data 95 .

[0066] In addition, the subject 4 may receive, via one or more electrodes, a signal from a single device, such as a monitor 49. 1, or more monitors. Monitor 49 is not intended to be limiting. However, the heart function is not limited to the above, and is configured to generate data regarding cardiac function, such as systole and diastole. The device may include an electrocardiogram monitor that indicates various conditions of the subject. The shape of the pulse is almost the same at a particular cardiac phase even across different cardiac cycles. ,Knowing the cardiac phase can be used to aid in tracking the vascular centerline.

[0067] Therefore, when angiographic data span a few cardiac cycles, the vascular centers at the same cardiac phase First-order matching of lines tracks the centerline throughout the pullback In addition, since most of the heart's motion occurs during systole, vasomotion , is expected to be higher near systole and weaken toward diastole. This is because One or more software measures of the amount of motion expected between imaging frames. Provides data to the module. Knowledge of expected motion is used to generate adaptations based on expected motion. Adaptive constraints improve tracking quality and vascular central line quality. may be used by one or more software modules to improve the quality good.

[0068] [Shadow detection embodiment] The present disclosure is directed, in part, to a method for detecting a stent shadow that results in a detected shadow. Method and system for determining the exact offset or location of a strut Sometimes in the shadows, against a background of dark shadows in the scan lines, there is a bright stratum bloom or There is a single possible strut location that corresponds to the peak. Multiple strut peaks were often detected within the stent struts, which may have led to incorrect placement of the stent struts. Spurious peaks are caused by, for example, blood pooling, pullback, Insufficient blood clearing in the zone or imaging optics interacting with metal struts This can be caused by ringing artifacts due to The present disclosure provides a method and system for identifying the best candidate for a true stent within a stent shadow. Provide the system.

[0069] FIG. 10A illustrates a blood vessel 5, such as an artery, a data collection probe 7, and intravascular data collection and processing. FIG. 10 is a high-level schematic diagram depicting the system 10. The method described with respect to FIG. 1 and other systems. For example, OCT, intravascular ultrasound (IVUS), or other intravascular imaging systems may be included. A stent 12 is shown in a blood vessel 5. The stent includes a plurality of struts. Some of the tents are shadowed as part of the process of imaging blood vessels with an intravascular probe. Alternatively, the system 10 may generate a shadow region SR. , side branch detection, peak detection, shadow area detection and processing, error correction, indicator bar generation and display Various solutions suitable for performing the display, model comparison, lumen detection, and various other processes are provided. The system 10 may include the application software modules described herein. Choose the right light source to meet the coherence and bandwidth requirements of your application and data collection. The system 10 may include an ultrasound imaging system. The probe 7 may include A catheter section having one or more optical fibers 15 and a probe disposed therein. The catheter 20 may include a lobe tip 17. The lobe tip 17 includes a beam director.

[0070] As shown, a catheter 20 is introduced into a lumen 11, such as an arterial lumen. The probe 7 directs light into the lumen L or in a direction perpendicular to the longitudinal axis of the fiber 15. The fiber 15 may include a rotating or slidable fiber 15 that guides the fiber 15 forward. For light directed from the side of the probe as fiber 15 rotates, OC T data is collected with respect to the wall of blood vessel 5. The wall of blood vessel 5 defines the luminal boundary. The lumen boundary is detected at the probe tip 17 using a lumen detection software component. The side branches and stems may be detected using distance measurements obtained from the collected optical signals. The tent struts as well as the shadowed areas and other features are the result of the probe being pulled back through the artery. may be specified in the scan lines generated during

[0071] In one embodiment, the probe 7 is an OC, such as an ultrasound in one embodiment. Other imaging modalities may be included in addition to T. In one embodiment, the luminal / luminal The boundary is imaged by light or ultrasound and an intravascular image that produces a signal of interest for imaging the blood vessel. This refers to the portion of the blood vessel that is first struck by the presence of a marker probe. This is typically Image processing in the form of squeegee is used to exclude any blood flowing within the vessels being removed. In one embodiment, the lumen or luminal boundary is located in front of the blood vessel wall and is adjacent to the blood-containing The term refers to the area of ​​tissue adjacent to the target area.

[0072] As shown in FIG. 10A, the probe tip 17 is positioned in the stented region of the blood vessel 5. The probe tip 17 is disposed within the lumen L so as to be distal to the , configured to receive backscattered light from objects such as the stent 12 and the walls of the blood vessel 5. The probe tip 17 and the remainder of the data collection probe 7 are connected to a lumen L. As shown in FIG. 10B, the probe 17 may be pulled through the blood vessel before or after insertion. The probe 7 is in optical communication with the OCT system 10. The optical fiber 1 The OCT system or subsystem 10, which connects to the probe 17 via 5, includes a laser or the like. a light source, an interferometer with a sample arm and a reference arm, various optical paths, a clock generator The OCT system may include a tunable optical fiber, a photodiode, and other OCT system components.

[0073] In one embodiment, a light receiving system, such as a balanced photodiode based system, An optical receiver 31 can receive the light leaving the probe 7. A computing device 40, such as a computer, processor, ASIC or other device, controls the OCT system. 10 or in electrical or optical communication with the OCT system 10. The computing device 40 may be included as a separate subsystem for processing the data. memory, storage, buses and other components suitable for side branch detection, stem Selection or identification of stent strut candidates, detection of candidate stent strut shadow areas, stent image Correlation and comparison of data stent visualization and pullback data collection as described below software 44, such as an image data processing stage, adapted for may include:

[0074] In one embodiment, the computing device 40 includes a side branch detection module, a lumen detection module, , a stent detection module, a stent strut confirmation module, a candidate stent strut Software modules or programs, such as application specific modules and other software The software module or program The system 44 includes an image data processing pipeline or its component modules, and one or more may further include a graphical user interface (GUI). The various software-based methods described in the document are 4. Modules may be subsets of each other, They may be arranged and connected through various input, output and data classes.

[0075] One exemplary image processing pipeline and its components includes one or more A software program or module 44 may be configured. 44 is a diagram showing a blood vessel lumen, a side branch, a guide wire, a guide catheter, a stent strut and a strut Several image processing algorithms tailored to detect tent regions The present disclosure may include image processing to determine the location of the metal strut within the shadow. Image data processing pipeline and its component software modules and related methods, as well as any of the methods described herein, are stored in memory. and uses one or more computing devices, such as a processor, device, or other integrated circuit. It is executed.

[0076] As shown in FIG. 10A, the display 46 also displays the OCT or IVUS Transverse and longitudinal cross-sections of blood vessels generated from the imaging data, as well as apposition bars and other indicators. An indicator, such as a marker, may be part of the system 10 to display information 47. The processing software algorithm 44 detects and corrects the presence of detected stents, side branches, guidewires, etc. and providing data corresponding to the image features selected, the data indicating whether the features correspond to a cross-section of the GUI, The inputs are then input to the GUI, which are displayed in the desired format on the longitudinal and / or 3D display sections. 0B images can be displayed and interacted with using a GUI and a variety of input devices. Specifically, it is an example of display information 47 of a coronary artery containing a metal stent. A 2D cross-sectional view is shown.

[0077] In addition, the display information 47 may include, but is not limited to, information related to the OCT system and data collection platform. Transverse scan data, longitudinal scans, diameter graphs, image masses acquired using lobes stents, areas of malapposition, luminal boundaries, and other images or representations of blood vessels or substrates. The computing device 40 may also include software or programs. 44, which may be stored in one or more storage devices 4 5, for example, as text, arrows, color coding, highlights, contours, or other suitable The stent struts and (e.g., thresholds and measured distances) may be aligned using a human or machine readable indicator. The level of incomplete contact, the shadow area, and the strut arrangement within the shadow area (based on comparison with the distance from the The system may be configured to identify other vascular features in addition to the vascular

[0078] FIG 10B is a cross-sectional OCT image of a stented vessel in accordance with the present disclosure. The lumen / lumen boundary of 10 is in the center of the image. The guidewire shadow 12 is at the top of the image. You can see it from 2:00 to 1:00. Also visible in FIG. 10B is There are a number of metallic stent struts 14, which cast a shadow 16 in the OCT image. Coherent light, typically used for OCT imaging, penetrates the stent struts. Instead, the metal stent struts cast a shadow on the vessel wall. The present disclosure provides a robust method for detecting the exact offset of a strut within the strut shadow. Once detected, the shadows and struts in FIG. Used to generate the user interfaces and indicators described in This may also be the case.

[0079] FIG. 11 is a process flow diagram for detecting struts in OCT image data. The method 100 separates shadows corresponding to stent struts in multiple OCT pullback frames. The method 100 may include one or more steps described herein. Unless otherwise required, these steps may be performed in any order. The metal strut detection method is based on the guidewire (140), side branch (130) and strut. From other image / endovascular data processing modules, such as information about the location of the shadow (110) The process flow and associated method steps and stages are The images were taken using OCT, IVUS, or other intravascular data acquisition systems. The system may operate based on the endovascular data or raw data 120. The data 120 is processed by one or more image processing modules in a pipeline. It is being processed.

[0080] In step 110, whether the shadow can be attributed to a side branch vessel or a guidewire To determine the side branch detection module 130 and the guide The data input from the wire detection module 140 is compared or correlated. Methods, systems and devices for detecting rat shadows, side branches and guidewires are known. See, for example, U.S. Patent No. 8,412,312; U.S. Patent No. 8,478,387. Details; U.S. Patent No. 8,831,321; U.S. Patent No. 9,138,147 and See U.S. Patent No. 9,173,591.

[0081] In step 150, if a given shadow can be attributed to a guidewire or a side branch, If so, the shadow is discarded and analysis for that shadow ends. whether by direct detection or by a process of elimination If it is determined that a given shadow can be attributed to a stent strut, the shadow is The shadow boundary is then analyzed to calculate or isolate the shadow interior. The scan lines or A-lines that correspond to the "darkest" areas are split off so that only the scan lines or A-lines that correspond to the "darkest" areas are kept. The reason for this is that the shadow areas, specifically the shadow onset and and stop scan lines may sometimes include outflow from neighboring lumen pixels. By isolating the interior of the shadow and ignoring the transition scan lines in the shadow margin, This improves the assessment of strut offset.

[0082] In step 170, the shadow interior is calculated by dividing each sample across the scan line that corresponds to a portion of the shadow interior. Each scan line is sampled and analyzed to calculate the projection (or sum) of the In the input OCT image data, each scan A line refers to data acquired along a particular angular direction centered on the imaging catheter. The scan lines are then radially sampled, with the spacing between pixels or "samples" being Each sample in the OCT data is typically a few microns wide, Generally, the size is uniform. The "projection" is summed over each scanline ( In other words, a two-dimensional shadow in {scanline, sample} space is The i-th index is the sum of the i-th samples of each scan line involved in the process. The projection is a one-dimensional signal that corresponds to the samples at radius R. They are included from the constituent scanlines at the same radius R. is the sample average.

[0083] In step 180, the projection is computed based on at most the three (e.g., 1, 2, or 3) largest The location or offset of each selected maximum is used as a potential strut. which is the best candidate to be the true strut. Certain characteristics of the selected maximum are then analyzed to determine whether In some embodiments, only the largest maximum value is selected. Two or three of the maxima are selected. The initial selection of multiple maxima increases the sensitivity. More than three maxima may be selected, but typically the three highest maxima are chosen. This is typically not necessary since one represents the true strut position. The process is illustrated in FIGS.

[0084] FIG. 12 is a logarithmic scale A-line or scan line OCT image of a stented vessel. The box 155 on the right side of the image indicates the shadow under analysis, and FIG. A projection graph is shown. The vessel lumen L is the dark area at the top of the image, and the vessel wall 18 is the dark area at the bottom of the image. The L is generally used herein to denote the lumen. The stent 14 and stent shadow 16 can be seen in the image. In this case, the lumen is the boundary between the tissue and the cleared interior of the blood vessel.

[0085] FIG. 13 is a graph showing the detection of multiple potential struts in a single shadow. 3 is a plot of the projection over the inner shadow scan line. Two maxima 22a and 22b are These maxima correspond to two potential strut positions in the shadow. These positions are displayed on the user interface as shown herein. To visualize the struts, an intravascular imaging system such as an OCT or IVUS system is used. This may be used by

[0086] An additional filter may be applied to the local maxima to remove false positives. In the embodiment, the local maximum is determined by the fact that it is one of the global peaks (the maximum value along the maximum projection). Glow is selected only if it has a signal greater than 1 / 10 (i.e., 10%). The maximum peak is the peak with the largest amplitude. The 10% threshold is used to eliminate spurious signals due to noise. The threshold is set to 5% of the global peak (i.e., 1 / 20) and 10%, for example, 5%, 6%, 7%, 8%, 9%, or 10%. In various embodiments, the peaks may be close to each other, preferably 10%. If detected, only the largest peak is selected for further analysis.

[0087] In step 190, the selected maxima are compared to determine whether any maxima are true struts. The struts are then examined from their immediate vicinity to determine which has the highest probability of being Based on the available information, the relative score is determined based on one or more of the following criteria: Each strut is assigned a number based on: 1. Proximity to the Lumen: The maxima selected are based on their proximity to the luminal boundary. The maxima closest to the lumen around the strut shadow received the highest score, and The maxima furthest from the lumen around the tratt shadow receive the lowest scores. 2. Peak Intensity: The selected maxima are scored based on their peak intensity. The maxima with the highest peaks receive the highest scores, and the maxima with the lowest peaks receive the lowest scores. Receive the core. 3. Degree of in juxtaposition: The selected maxima are juxtaposed to the lumen (in juxtaposition The luminal or blood vessels are scored based on their apposition. Maxima located within a given acceptable distance from the canal wall were associated with higher malapposition scores. Struts that are too far from the lumen or vessel wall (one or more interfaces) The treatment options are determined or accepted by user-specified thresholds using a screen. are penalized and considered less likely to be potential false positives. In one embodiment, the strut receives a poor malapposition score. Depending on whether or not the apposition is present, the apposition is assigned a score of either 0 or 1. You may do so.

[0088] These scoring criteria are exemplary and additional criteria may be used based on other strut and shadow features. A scoring criterion may be used. In one embodiment, the candidate stent struts are Sections of the struts are adjacent to or aligned with other sections in adjacent or nearby frames. If the strut is in the cross-frame analysis, it shows that the strut is effective. This is confirmed using the FTIR analysis.

[0089] Each maximum gets a combined score which is a linear sum of the above criteria. The local maximum with the highest score is selected as the valid strut. The remaining maxima are considered as alternative or backup struts until further analysis is performed. In case of a tie, the maximum closest to the lumen and / or the brightest maximum are selected. Used as a tiebreaker. Table 1 shows an example of one of the maxima for the stent shadow. Provides a ranking. Table 1: Maximum ranking for stent shadows [Table 1]

[0090] As shown in Table 1, maximum 1 has the highest total score and is therefore the candidate valid score. Maximum 2 and 3 are designated as backup struts. It is determined.

[0091] In step 220, all the maxima (including the active struts and any backup struts) are rat) undergoes multiframe validation. In this step, adjacent frames are The active struts in one frame are the active struts selected for the adjacent frames. The struts are compared to other cross frames to ensure that they are aligned. If the backup strut is not aligned with the cross frame If the strut fits the model better, then the effective strut is the backup strut. One embodiment of the multiframe verification step may be replaced by Stent strut geometry and position information may be used. Other embodiments using a set of markers and shadow features may also be used for this step. That is, the location and geometry are based on previous pullback data or other user-supplied data. Along with other features, such as information, all may be used as features.

[0092] Once detected, the active or selected strut is displayed on the user interface. It may be possible to determine the exact location of the stent struts as well as the placement of the stent. Whether adjustments are needed to optimize and / or speed up the process and reduce the risk of side effects The user interface provides important visual aids to the clinician regarding the cross-sectional Images, L-mode images, scan line images, 3D renderings, or detected struts can be viewed. The user interface may include any other suitable display format for visualizing the The face also includes indicator bars, angiographic data, and other data described and illustrated herein. Other views and features may be depicted.

[0093] The detection algorithm accurately identifies the location of the struts, and its sensitivity is in one embodiment. The detection algorithm detects the location of the struts in a range of about 80% or more. The sensitivity ranged from about 0.01 to about 0.001 in one embodiment. In one embodiment, the sensitivity is determined by the total number of struts (properly located). The number of accurately located struts divided by the number of struts (single struts) and missing struts (single struts) The positive predictive value is the percentage of cases in which the positive predictive value is 0.01. In this study, we divided the total positive calls (the sum of correctly detected struts and false positives) by the number of positive calls. The various features described herein are the percentage of struts that are accurately detected. Use with multiple different cath lab systems such as intravascular imaging and pressure measurement systems The indicators and detection steps described herein are suitable for use by diagnosticians. and provides various benefits to those planning stent deployment or evaluating deployed stents. Glass.

[0094] The use of directional arrowheads, or the lack thereof, in a given figure allows information to flow. It is not intended to limit or require any particular orientation. For example, the orientations shown in Figures 1 and 10A may be different. For a given connector, such as the illustrated arrows and lines connecting the elements being connected, the information is Flow may occur in one or more directions, or only in one direction, as appropriate for a given embodiment. The connection may be any suitable connection, such as optical, wired, power, wireless, or electrical connection. It may also include a data transmission connection.

[0095] Some parts of the detailed description refer to operations on data bits within a computer memory (e.g., These algorithmic descriptions are presented in terms of the algorithms and symbolic representations of the operations. The statements and representations are intended to be used by those of ordinary skill in the computer and software related arts. In one embodiment, the algorithm, as used herein and generally, It is considered to be a self-consistent sequence of actions that leads to a result. Actions performed or otherwise described in the specification as method steps may be taken as These quantities are usually, but not necessarily, conserved quantities. be transferred, combined, transformed, compared, and otherwise The signals take the form of electrical or magnetic signals that can be manipulated in this manner.

[0096] [Non-limiting software for implementing the interface, detection, and other features of the disclosure. Features and embodiments of the present invention The following description is of an apparatus suitable for carrying out the methods of the present disclosure described herein. It is intended to provide an overview of the hardware and other operating components. The descriptions are not intended to limit the applicable environments or the scope of the present disclosure. The hardware and other operating components are included as part of the equipment described above. The present disclosure relates to personal computers, multiprocessor systems, microphones, and the like. processor-based or programmable electronic devices, network PCs, minicomputers , may be practiced using other system configurations, including mainframe computers, etc. The present disclosure also provides a method for communicating with a catheter through a communication network, such as within different rooms of a catheter or cath lab. A distributed computing environment in which tasks are performed by linked remote processing devices. It may be practiced in

[0097] Some portions of the detailed description refer to operations on data bits within a computer memory. These algorithmic descriptions and representations are presented in terms of algorithms and symbolic representations. It can be used by anyone skilled in the art of computers and software. In the embodiments, an algorithm is defined herein, and generally, as a method for producing a desired result. It is believed to be a self-consistent sequence of operations. The operations performed or otherwise described do not require physical manipulations of physical quantities. These quantities are typically, but not necessarily, stored, transmitted, bound, and capable of being processed, transformed, compared, and otherwise manipulated; It may take the form of an electrical or magnetic signal.

[0098] Unless otherwise specified, as will become apparent from the following description, Therefore, "processing" or "computing" or "searching" or "indicating" or "detecting" or "measuring" or "Calculating" or "Comparing" or "Generating" or " "Sensing" or "Determining" or "Displaying" Descriptions utilizing or operations involving Boolean logic or other sets of logic may be implemented in a computer system. or electronic device operations and processes, which operations and processes are implemented in a computer system. It manipulates data represented as physical (electronic) quantities in the registers and memories of a computer or electronic device. , in electronic memory or register or other such information storage, transmission or display device It will be clearly understood that this may be converted to other data similarly expressed as a logical quantity.

[0099] The present disclosure also relates in some embodiments to apparatus for performing the operations herein. This equipment may be specially constructed for the required purpose or it may be Selectively activated or reconfigured by a computer program stored on the computer Various circuits and their components are described herein. It is used to perform some of the data collection and transformation and processing described in This may also be the case.

[0100] The algorithms and displays presented herein may be implemented using a particular computer or other Various general purpose systems may be used in accordance with the teachings of this specification. Alternatively, various general purpose systems may be used in conjunction with the program according to the It may prove advantageous to construct more specialized equipment to perform the method steps. The required structure for a variety of these systems will appear from the description below. In addition, this disclosure is not described with reference to any particular programming language. , and therefore different embodiments may be implemented using different programming languages. In one embodiment, the software instructions are for use with an intravascular imaging / data collection system. It is adapted to run on a microprocessor or ASIC.

[0101] Embodiments of the present disclosure include a processor (e.g., a microprocessor, a microcontroller, for use with a computer (such as a digital signal processor, Field programmable logic, programmable logic devices (e.g., field programmable For use with FPGAs or other programmable logic devices programmable logic, discrete components, integrated circuits (e.g., (ASIC), or any other means including any combination thereof However, the present invention may be embodied in many different forms, and is in no way limited to these. In an exemplary embodiment of the present disclosure, an OCT probe and a processor-based system The information collected using the system or used to generate control signals or to provide a user interface Some or all of the processing of the data used to initiate the command may be performed by a computer program. The instruction set is implemented as a set of program instructions in a computer-executable form. and storing it in a computer readable medium, It is executed under the control of a microprocessor.

[0102] Thus, queries, responses, transmitted probe data, input data and other data, And the signals described herein are responsive to user interface selections. and controlling a graphical user interface, the control and graphic signals and displaying cross-sectional information and images from other data acquisition modalities; Generating and displaying stents and apposition bars and other intravascular data, angiography, OC A processor adapted to display T, detect shadows, and detect peaks. The understandable instructions and other data are provided by a graphic user interface and the above. As part of such other features and embodiments, the GUI component or as a troll or other representation in a graphical user interface Suitable data and parameters for display include, but are not limited to, non-contact values, juxtaposition bars, status ntstrats, missing data representation, indicator bars, shadows, angiogram representation, Three-dimensional and two-dimensional renders and views, as described herein The present invention includes other features as described above.

[0103] A computer program implementing all or part of the functionality described above in this specification. The Software Logic may be provided in source code form, computer executable form, and various intermediate forms (e.g. For example, generated by an assembler, compiler, linker, or locator. The present invention may be embodied in various forms, including, but not limited to, any form of Without limitation, the Source Code may be distributed to various operating systems or Various programming languages ​​(e.g. object coding) are available for use in the , assembly language, Fortran, C, C++, JAVA, or is a set of computer programs implemented in one of several high-level languages, such as HTML The source code may include system instructions. The source code defines various data structures and communication messages. Source code may be used for computer execution (e.g., via an interpreter). The source code may be in executable form (e.g., translator, assembler, etc.) The program may be converted into a computer-executable form (via a program block or compiler).

[0104] The computer program is stored in a semiconductor memory device (e.g., RAM, ROM, PROM, E EPROM, or flash-programmable RAM), magnetic storage media (e.g. disk hard disks, optical storage devices (e.g., CD-ROMs), PC cards (e.g., In any form, on a tangible storage medium, such as a PCMCIA card, or other storage device. in a permanent form (e.g., in source code form, computer executable form, or intermediate form) Computer programs may be implemented in analogue, digital or mechanical form. technology, optical technology, wireless technology, networking technology, and internetworking technology Using any of a variety of communication technologies, including but not limited to The information may be fixed in any form in a signal that can be transmitted to a computer. The data program can be used to convert printed or electronic documents (e.g., shrink-wrapped documents). ed) Software) may be distributed in any form, including on a removable storage medium. , by using a computer system (e.g., in a system ROM or on a fixed disk) The software may be loaded directly into the computer or distributed over a network.

[0105] Hardware logic (programs) that implements all or part of the functionality described hereinabove (including programmable logic for use with programmable logic devices) They may be designed using manual methods or computer-aided design (CAD), hardware A hardware description language (e.g., VHDL or AHDL), or a PLD programming language (e.g., Electronically designed using various tools such as PALASM, ABEL, or CUPL , may be captured, simulated, or documented.

[0106] Programmable logic is a semiconductor memory device (e.g., RAM, ROM, PROM, E EPROM, or flash-programmable RAM), magnetic storage devices (e.g. a hard disk, a USB stick, or a fixed disk, an optical storage device (e.g., CD-ROM), or other storage device The program may be permanently or temporarily fixed in a tangible storage medium, such as a Le logic is a combination of analog, digital, optical, and wireless technologies (e.g., Bluetooth). (registered trademark), networking technologies, and internetworking technologies. using any of a variety of communication technologies, including but not limited to The programmable logic may be fixed in a signal that can be transmitted to a computer. Removable storage devices with printed or electronic documents (e.g., shrink-wrapped software) The present invention may be distributed as a storage medium, using a computer system (e.g., a system RO M, or fixed disk) or may be installed in a communication system (e.g., Distributed via the Internet or World Wide Web from a server or bulletin board. This may also be the case.

[0107] Various examples of suitable processing modules are described in more detail below. When configured, the module is configured to execute a particular data processing or data transmission task. Refers to software, hardware, or firmware suitable for performing In a preferred embodiment, the module receives instructions, or OCT scan data, user input, Interface data, control signals, angiographic data, user actions, frequencies, interferometer signals Data, Detected stents, Candidate stent struts, FFR data, IVUS data , shadow, pixel, intensity pattern, score, projection, side branch data and guidewire data, Various types of data, such as other information of interest as described herein, and a software routine adapted to receive, convert, route, and process the data. , a program, or other memory resident application.

[0108] The computers and computer systems described herein are to store software applications used for processing, storage and / or communication; a machine-readable medium, such as a computer-readable medium, operatively associated therewith, such as a memory of Such memory may include a computer or processor with which it is operatively associated. With respect to a computer system, it may be internal, external, remote, or local. will be understood.

[0109] Memory may also be, for example, a hard disk, an optical disk, a floppy disk, DVD (Digital Versatile Disc), CD (Compact Disc), Memory Stick tick, flash memory, ROM (read only memory), RAM (random access memory), DRAM (Dynamic Random Access Memory), PROM (Programmable ROM), EEPROM (Extended Erasable Programmable Read Only Memory), and / or other similar computer programmable Any data-readable medium for storing software or other instructions, including, but not limited to, The present invention may include any means for detecting a

[0110] Generally, a computer program applied in conjunction with the embodiments of the present disclosure described herein. The data-readable storage medium is capable of storing instructions that are executed by the programmable device. If applicable, the methods described herein may include any storage medium. The steps may be embodied or implemented as instructions stored on a computer-readable storage medium or memory medium. These instructions may be written in a variety of programming languages, including C++, C, Java, etc. language, and / or various other language that may be applied to create instructions according to embodiments of the present disclosure. The software may be embodied in any of a variety of software programming languages.

[0111] The term “machine-readable medium” or “computer-readable medium” refers to a medium that can be executed by a machine. A set of instructions can be stored, encoded, and maintained in a machine. The present invention includes any medium capable of performing any one or more of the methodologies described herein. Although shown in one exemplary embodiment as a single medium, the term "machine readable" A "readable medium" refers to a medium or multiple media (including, but not limited to, a USB flash drive) that stores one or more sets of instructions. For example, a database, one or more centralized databases or distributed databases. and / or associated caches and servers).

[0112] The storage medium may be non-transitory or may include a non-transitory device. Accordingly, the non-transitory storage medium or non-transitory device may include a tangible device, Although the physical state of a substance can be changed, this means that it has a concrete physical form. So, for example, non-transient means that something remains tangible despite this change in state. This refers to a device that

[0113] The aspects, embodiments, features, and examples of the present disclosure are considered to be illustrative in all respects. and are not intended to limit the scope of the present disclosure, the scope of which is limited only by the claims. Without departing from the spirit and scope of the claimed disclosure, Other embodiments, modifications and uses will be apparent to those skilled in the art.

[0114] The use of headings and paragraphs in this application is not meant to limit the disclosure. Rather, each paragraph may apply to any aspect, embodiment, or feature of the disclosure.

[0115] Throughout this application, compositions are defined as having, including or comprising specific components. When a process is described as having or including specific process steps, When described as including or comprising, the composition of the present teachings consists essentially of the recited components. It is also contemplated that the process of the present teachings may be substantially or consisting of the process steps recited in is also expected.

[0116] In this application, an element or component may be included in a recited list of elements or components. And / or when referred to as being selected from the list, the element or component is It may be any one of the listed elements or components, and the listed elements or components It should be understood that the element may be selected from a group consisting of two or more of the elements. Furthermore, the elements and / or features of the compositions, devices, or methods described herein may be Whether expressly or implicitly stated herein, the spirit and scope of the present teachings It should be understood that the above-mentioned embodiments may be combined in various ways without departing from the spirit and scope of the present invention. do.

[0117] The terms "include," "includes," "including," "have," "having," "having The use of g) is generally open-ended and non-limiting unless otherwise stated. It should be understood that

[0118] The use of the singular herein includes the plural unless specifically stated otherwise (and vice versa). Moreover, unless the context clearly dictates otherwise, the singular form "one, that" is used interchangeably. When the terms "a," "an," "the," or "number" are not limited, the plural is included. In addition, the term "about" Where the use of is before a quantitative value, the present teachings are directed to a specific The quantitative value itself includes ±10%.

[0119] The order of steps or order for performing certain actions may be changed without departing from the spirit or scope of the present teachings. It should be understood that the number of the two or more is immaterial, so long as the number of the two or more is not greater than the number of the two or more. One or more steps or actions may be performed simultaneously.

[0120] If a range or list of values ​​is provided, between the upper and lower limits of that range or list of values Each intervening value is contemplated separately and is treated as if each value were specifically recited herein. In addition, any range between and including the upper and lower limits of a given range is encompassed within the present disclosure. Smaller ranges are anticipated and encompassed within the present disclosure. A list of example values ​​or ranges is given. is not the exclusion of other values ​​or ranges between and including the upper and lower limits of the range.

[0121] The drawings and description of the present disclosure have been omitted for clarity while other elements have been omitted for clarity. It should be understood that the present invention has been simplified to show relevant elements for ease of understanding. Those skilled in the art will recognize, however, that these and other factors may be desirable. However, such elements are well known in the art and these elements Because a description of such elements does not facilitate a better understanding of the present disclosure, the description is not provided herein. The drawings are presented for illustrative purposes and are not intended as construction drawings. It should be understood that omitted details and modifications or alternative embodiments are within the skill of the art. within the knowledge of the

[0122] In certain aspects of the present disclosure, the components may be arranged to provide an element or structure or to provide a given function or function. A single component may be replaced by multiple components to perform multiple functions. and that multiple components may be replaced by a single component. It will be clearly understood that such substitutions may be made in order to implement certain embodiments of the present disclosure. Except where it would be ineffective to do so, such substitutions are deemed to be within the scope of the present disclosure.

[0123] The examples presented herein are intended to illustrate potential specific implementations of the present disclosure. These examples are intended primarily for illustrative purposes of the present disclosure for those skilled in the art. It can be clearly understood that without departing from the spirit of this disclosure, There may be variations in these diagrams or the operations described herein. For example, in some cases However, the method steps or actions may be executed or performed in differing orders or actions may include additional steps or actions. , may be deleted or modified.

[0124] Moreover, specific embodiments of the present disclosure have been described herein for purposes of illustrating the disclosure, and not for purposes of limiting the disclosure, and it will be apparent to those skilled in the art that numerous changes in the details, materials and configurations of elements, steps, structures and / or parts may be made within the principles and scope of the present disclosure without departing from the disclosure as set forth in the claims. In order to maintain the disclosure matters at the time of filing of the present application, the contents of claims 1 to 28 at the time of filing of the present application are added as follows. (Claim 1) 1. A method of stent strut detection, comprising: accessing a plurality of frames of intravascular imaging data, the plurality of frames comprising optical coherency tomography scan lines; identifying shadow regions corresponding to candidate stent struts; identifying scanlines corresponding to candidate stent strut shadow regions and generating candidate strut shadow scanlines; and analyzing the candidate strut shadow scan lines to identify the location of a stent strut; A method comprising: (Claim 2) The method of claim 1 , wherein identifying shadow regions corresponding to candidate stent struts comprises the sub-step of removing shadow regions corresponding to non-stent features. (Claim 3) The method of claim 2 , wherein the non-stent feature is selected from the group consisting of a guidewire, a side branch, and combinations thereof. (Claim 4) The method of claim 1 , further comprising the step of eliminating candidate strut shadow scanlines that contain lumen pixels. (Claim 5) The method of claim 1 , wherein the analyzing step includes the substep of determining a projection across each of the candidate strut shadow scanlines by summing signal responses across the candidate strut shadow scanlines. (Claim 6) The method of claim 5, comprising the substep of identifying up to three maxima in the projection. (Claim 7) The method of claim 6, further comprising the substep of ranking the maxima based on peak signal strength to generate a peak score. (Claim 8) 8. The method of claim 7, wherein the ranking substep is an ordinal ranking in which maxima having higher peak signal strength receive higher peak scores. (Claim 9) The method of claim 8 , further comprising the substep of ranking the maxima based on their proximity to a vessel wall to generate a proximity score. (Claim 10) 13. The method of claim 1, further comprising an apposition bar aligned with a stented region, the stented region including a located stent strut, the apposition bar being rotationally agnostic or persistent. (Claim 11) The method of claim 10, comprising assigning each local maximum a malapposition score. (Claim 12) The method of claim 11 , wherein the poorly aligned score is binary, with poorly aligned maxima receiving a score of zero. (Claim 13) 13. The method of claim 12, comprising summing a peak score, a proximity score and the malapposition score, and the local maximum having the highest total score is designated as the location of the stent strut. (Claim 14) identifying a plurality of shadow regions corresponding to candidate stent struts; identifying a scan line corresponding to each candidate stent strut shadow region; and identifying a location of a stent strut within each candidate stent strut shadow region; 14. The method of claim 13, comprising: (Claim 15) 15. The method of claim 14, comprising performing a cross-frame analysis to identify the designated stent strut across multiple optical coherence tomography (OCT) imaging frames. (Claim 16) The method of claim 15, further comprising displaying the identified stent struts on a graphical user interface. (Claim 17) 10. The method of claim 1, further comprising the steps of displaying indicia of stent struts on a graphical user interface, and displaying indicia indicating one or more areas within the intravascular image for which data was unavailable for display. (Claim 18) 1. A stent delivery planning system comprising: a processor in communication with the graphical user interface and configured to send instructions to the graphical user interface; the graphical user interface is configured to display image data from an optical coherence tomography procedure in a first panel corresponding to a longitudinal cross-sectional view of a blood vessel, the graphical user interface is configured to display intravascular imaging data corresponding to a view of the blood vessel in a second panel; one or more indicators are selectable by the processor for overlay or inclusion on one or more of the first panel and the second panel. system. (Claim 19) 20. The system of claim 18, wherein at least one indicator is persistent in response to user navigation input. (Claim 20) 20. The system of claim 18, wherein the one or more indicators are disposed in one or more panels to identify one or more stents relative to a luminal border vessel and areas of malapposition. (Claim 21) 19. The system of claim 18, wherein the one or more indicators are positioned within one or more panels to highlight stent position and malapposition determination, and the indicators are rotationally agnostic to user rotational selection of a user interface view. (Claim 22) 20. The system of claim 18, wherein the one or more indicators are disposed in one or more panels to highlight a location of the stent relative to an angiographic image of the blood vessel and an optical coherence tomography image of the blood vessel. (Claim 23) 20. The system of claim 18, further comprising a first display comprising the first panel, and a second display comprising the second panel. (Claim 24) 20. The system of claim 18, wherein the one or more indicators are disposed within one or more panels to guide expansion of the stent. (Claim 25) 20. The system of claim 18, wherein the indicator is selected from the group consisting of a longitudinal indicator, a bar, a simulated stent, a color, an icon, or other screen-visible element. (Claim 26) 1. A method for identifying strut location characteristics relative to a vessel wall, comprising: determining a luminal boundary of the blood vessel using the endovascular data; using the intravascular data to determine one or more positions of one or more stents within the blood vessel; generating an apposition bar indicative of stent strut placement within the vessel and one or more areas of stent malapposition; and displaying an OCT image with said apposition bars; Includes, a method. (Claim 27) The method of claim 10 further comprising displaying an angiographic image with an indicator co-registered with the apposition bars. (Claim 28) 1. A method of stent strut detection, comprising: storing a plurality of frames of intravascular imaging data; detecting stent struts within a first group of frames of the plurality of frames; detecting one or more shadow regions in the first group of frames, one or more of the shadow regions adjacent a detected stent strut; determining on a shadow region by shadow region basis whether a given shadow region is due to a guidewire or a side branch, and generating a set of candidate stent strut shadow regions, each candidate stent strut shadow region including a shadow boundary; identifying scan lines of candidate stent strut shadow regions within the shadow boundary; A method comprising:

Claims

1. 1. An intravascular data acquisition and processing system for detecting stent struts, comprising: one or more memory devices; one or more processors in communication with the memory device; It is equipped with The one or more processors: Accessing multiple frames of intravascular image data; identifying a plurality of shadow regions in the plurality of frames; Remove some shadow areas corresponding to non-stent features; identifying a number of scan lines that correspond to the plurality of shadow regions and that include candidate stent struts; analyzing the candidate stent struts including several scan lines to identify a location of the stent struts; performing a cross-frame analysis to identify a number of candidate stent struts across multiple frames using one or more geometric features; If one of the candidate stent struts is not valid, then replacing the candidate stent strut with an alternative stent strut based on the cross-frame analysis.

23. An intravascular data acquisition and processing system configured to:

2. The system of claim 1 , wherein the non-stent feature is at least one of a guidewire and a side branch.

3. The system of claim 1 , wherein the plurality of frames of intravascular image data are stored in an electronic memory in electrical communication with an imaging system.

4. The system of claim 1 , wherein removing the shadow region further comprises removing a shadow region that includes lumen pixels that isolate an interior of the shadow region.

5. The system of claim 1 , wherein the one or more processors are further configured to score the candidate stent struts based on their proximity to a luminal boundary.

6. The system of claim 1 , wherein the one or more processors are further configured to score the candidate stent struts based on malapposition of the candidate stent struts.

7. The system of claim 6 , wherein candidate stent struts having a malapposition score exceeding a threshold based on distance from the luminal boundary are identified as false positive detections.

8. The system of claim 1 , wherein each candidate stent strut corresponds to a local maximum having a peak intensity, and the candidate stent struts are scored based on the peak intensity.

9. The system of claim 8 , wherein the one or more processors are further configured to rank the local maxima based on peak intensity to generate a peak intensity score.

10. The system of claim 1 , wherein the one or more processors are further configured to provide each candidate stent strut with a plurality of scores that can be combined to generate a combination score.

11. The system of claim 10 , wherein the plurality of scores is selected from the group consisting of a peak intensity score, a proximity to luminal boundary score, and a local maximal malapposition score.

12. The system of claim 1 , wherein the one or more processors are further configured to provide one or more effective stent struts included in the endovascular representation for display on a graphical user interface.

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