Methods and systems for identifying vascular structure

Abstract

To provide intravascular data collection systems and methods for software-based visualization and display of intravascular data regarding detected side branches and detected stent struts.SOLUTION: Levels of stent malapposition can be defined using a slider, toggle, button, field, or other interface to specify how indicia are displayed for detected stents. Methods of automatically providing a two- or three-dimensional visualization suitable for assessing side branches and / or guide wires during stenting can use one or more of a computed side branch location, a branch takeoff angle, one or more stent locations, and one or more lumen contours.SELECTED DRAWING: Figure 2

Description

[Technical field]

[0001] This application is a joint venture of U.S. Provisional Application No. 62 / 196,997, filed July 25, 2015. This application claims the benefit of priority under 35 U.S.C. 119(e) from the application, the preamble of which is incorporated herein by reference. No. 6,399,433, filed on Oct. 23, 2003, and incorporated herein The present disclosure relates generally to intravascular measurement and feature detection and related diagnostic methods and devices. do. [Background technology]

[0002] Coronary artery disease is one of the leading causes of death worldwide. The ability to monitor and treat intravascular endothelial cell carcinoma can have life-saving consequences. Optical Coherence Tomography (OCT) uses light to see through the walls of the coronary arteries and produce images of them for study. Catheter-based imaging modalities. Coherent light, interferometry, and micro-optics. Using imaging techniques, OCT can reveal the inside of diseased blood vessels with micrometer-level resolution. It is possible to provide in vivo tomography of deorates. Viewing subsurface structures at high resolution using a microscope makes OCT a minimally invasive method of examining internal tissues and organs. This level of detail possible with OCT makes the clinician particularly useful for diagnostic imaging. OCT images allow for the diagnosis and monitoring of the progression of arterial disease. Provides high-resolution visualization of the histology of OCT images alone or in combination with angiographic data and other subjects In combination with other information, such as the source of data, It can assist in diagnosis and planning.

[0003] OCT imaging of parts of a patient's body provides a useful diagnostic tool for physicians and others. For example, imaging of coronary arteries with intravascular OCT can reveal the location of narrowing or stenosis. This information is provided to cardiologists to guide the selection of patients for invasive coronary artery bypass surgery and angioplasty or surgery. The present invention helps patients choose between catheter-based and less invasive procedures such as catheter delivery. Although a popular option, stent delivery has its own associated risks.

[0004] A stent is a tubular structure that is often made of mesh. It can be inserted into a vessel and expanded to counteract a stenosis that constricts blood flow. Stents are typically made of a metal or polymer framework. During cardiovascular procedures, stents can be deployed to the site of a stenosis via a guidewire. The catheter is delivered to the stenotic site via the catheter and then expanded using a balloon. Typically, stents are pre-configured to expand the lumen of a narrowed blood vessel. It is expanded using pressure. Angiography systems, intravascular ultrasound systems, OCT systems Used in combination or alone to facilitate stent delivery planning and stent placement. It is possible.

[0005] There are several factors that influence patient outcomes when placing a stent. In the procedure, the stent expands 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. This prevents dissection, disarticulation, and intra-mura bleeding of blood vessels. The underexpanded stent may cause insufficient expansion of the blood vessel. If parts of the stent fail to contact the vessel wall, the risk of thrombosis may increase. There are cases where the dentition is underinflated or poorly aligned (incomplete contact). Stents may not restore normal flow. Once placed, stent malapposition and stent failure can occur. Under-expansion of the flow can cause a variety of problems. The limiting stenosis is often located near a side branch vessel.

[0006] The side branches are partially or completely occluded or "occluded" by stent struts. For example, this can be done to address stenosis or other conditions. This can occur when a stent is placed in the main vessel. Side branches carry blood to downstream tissues. Therefore, jailing has undesirable ischemic effects. The ischemic effects of the restriction may occur when multiple side branches are impacted or when a single branch is occluded. The surface area is multiplied when it is significant.

[0007] There are other challenges associated with stent placement and related procedures. Visualizing stent placement against the wall of the artery can be challenging to do by inspection.

[0008] This disclosure addresses these and other challenges. Summary of the Invention

[0009] In part, the present disclosure relates to a method for detecting intravascular data, such as detected side branches and detected stent struts. The present invention relates to a system and method for visualizing data using an intravascular data collection probe. The probe can be pulled back through the blood vessel and data collected on it. In one embodiment, the probe is adapted for optical coherence tomography ( In one embodiment, the probe is an optical probe, such as an optical coherence tomography (OCT) probe. The present invention is an intravascular ultrasound probe (IVUS) such as a coherence tomography probe. In the various embodiments shown, the stent can be visualized relative to the side branch. This is an important feature because it avoids stenting the side branch during stent placement. The systems and methods described herein are for collecting Based on the detection of these features in the endovascular data, various user interfaces are and representation of stent struts and side branches to facilitate visualization of stents in side branches. .

[0010] In part, the present disclosure relates to an intravascular data collection system and a method for detecting side branches and detecting Software-based visualization and display of intravascular data related to stent struts. Any aspect of the stent strut on which the slider, toggle, button, field, or indicia is detected. Specify how the user interface is displayed, like any other interface. In addition, the present disclosure provides a method for determining the level of stent malapposition. 2D or 3D imaging suitable for assessing side branch and / or guidewire location during catheter placement The present invention relates to a method for automatically providing visualization of computed side branch locations, branch take-offs, and The method may use one or more of the following: the stent angle, the location of one or more stent struts, and one or more lumen contours. It is possible.

[0011] In part, the present disclosure relates to systems and methods for stent planning or otherwise. The present disclosure relates to a system and method for generating and displaying diagnostic information of interest. It also concerns the generation of suitable indicators and the integration of those indicators into the display of image data. As an example, a vertical indicator such as an apposition bar may be used alone. or with a stent strut indicator to aid in diagnostic planning such as stent planning. For example, a set of images or OCT scan lines are generated for The data set can be overlaid on top of the simultaneously recorded angiographic frames.

[0012] In part, the present disclosure provides, in one embodiment, a data set applied to an endovascular data set. The results of the data analysis are displayed to the user of the intravascular data acquisition system and to the angiography system. In part, the present disclosure relates to systems and methods for treating stent apposition and other conditions. It is easy to find and understand such regions of interest on OCT and angiographic images. It may be applied to one or more images of blood vessels or angiographic images so that the A graphic interface and graphical data representation that can Write the user interface (GUI).

[0013] In part, this disclosure relates to a catheter lab, such as an optical coherence tomography system. Regarding data acquisition systems, such as intravascular data acquisition systems suitable for use within the Thrift Lab, In part, the present disclosure provides 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 (OCT) imaging data or images. The system is generated using a stent strut-based longitudinal mode. Data on tent apposition failure or on the presence of one or more stents in a vessel Addresses stent, no stent, or stent malapposition levels of potential concern for and displaying a user interface for displaying intravascular information such as a bar having an area to be displayed. As a non-limiting example, in response to the stent detection process and the lumen boundary detection, Generate one or more indicators such as a longitudinal indicator, an angiographic image, an OCT image The user can view these images to determine the stent delivery. Plan and review the simultaneously recorded OCT and angiographic images with associated indications of interest. This allows the stent delivery to be expanded or adjusted.

[0014] The present disclosure relates, in part, to one or more viewing angles or OCT data for computer-based visualization of stent orientation and position within a vessel. The stent is visualized using one or more graphic user interfaces. Shown as part of the stent strut or part of the stent (GUI). The device may similarly detect and display the ID wire. In one embodiment, the disclosure provides , to visualize detected intravascular features and enhance their diagnostic value to the end user. a computer algorithm that displays them in an optimized or optimal manner suitable for The GUI uses OCT distance measurements to provide a software-based method for and side branching to increase diagnostic value or ease of use for the end user. or a position relative to the guidewire. .

[0015] In part, the present disclosure relates to a method for visualizing intravascular information obtained using an intravascular data collection probe. The method comprises: receiving endovascular data for a blood vessel, the endovascular data comprising a plurality of image frames; receiving the intravascular data; and storing the intravascular data in a memory device of the intravascular data collection system. and detecting one or more side branches on a per image frame basis. Detecting the lumen on a per image frame basis. determining a first viewing angle for at least one of the side branch or the lumen; and or displaying a three-dimensional visualization of at least one of the lumens. In the above, the lumen is the lumen boundary. In one embodiment, the lumen contour and the lumen boundary are They are interchangeable.

[0016] In one embodiment, the method includes creating a three-dimensional flow channel for at least one of the side branch or the lumen. In one embodiment, the intravascular data is displayed as an optical control. In one embodiment, each image frame is a scan line. In one embodiment, the method includes detecting a plurality of stent struts. In one embodiment, the method further comprises detecting one or more guidewires. The present invention further includes the following.

[0017] In one embodiment, the method includes determining a second viewing angle for a plurality of stent struts. In one embodiment, the method further comprises: In one embodiment, the three-dimensional visualization further comprises determining a third viewing angle. In one embodiment, the 3D fly-through is oriented at a viewing angle of 100°. The device is user controllable in one or more directions using the

[0018] In one embodiment, the method includes determining a side branch arc of the lumen contour; estimating the side branch orientation by fitting a cylinder constrained by In one embodiment, the method further comprises selecting an orientation of the cylinder to be rotated. determining an intermediate frame of the image frames of the intravascular data; Determining the arc position and direction towards the intravascular imaging probe for intermediate frames The method further includes setting an initial camera position for the three-dimensional view to match the three-dimensional view.

[0019] In part, the present disclosure provides a process for controlling a stent apposition threshold based on user input. The system includes one or more memory devices and one or more memory a computing device in communication with the device, the one or more memory devices including It includes instructions executable by a computing device, and these instructions The present invention relates to a method and apparatus for treating a stent strut apposition threshold comprising the steps of: Displaying a user interface and storing user-entered stent struts in one or more memory devices. A threshold apposition value is stored and is greater than or equal to 1 in an intravascular data set acquired using an intravascular probe. and detecting one or more stents and one or more marks associated with the one or more stents. The mark indicates the level of stent strut apposition, and the level of stent strut apposition is set by the user. The stent strut apposition threshold is determined using a selectable input. The position is a slider.

[0020] In one embodiment, the user selectable input is one or more values ​​of a slider. In one embodiment, the indicia is one or more colors. In one embodiment, the slider is It is configured to define three apposition thresholds. In one embodiment, The threshold control device measures the stent strut apposition to the anterior surface of the stent strut. In one embodiment, the stent strut stent apposition threshold control device comprises a foam fillable feeler. The input is selected from the group consisting of a key, a button, a toggle control, a dial, and a numerical selection input.

[0021] The patent or application file contains at least one drawing executed in color. A copy of this patent or patent application publication with color drawing(s) will be provided upon request and payment of necessary fees. Provided by the Patent Office upon payment. The drawings are not necessarily to scale, emphasis instead being generally placed on illustrative principles. The drawings are to be considered in all respects illustrative and not limiting of the present disclosure. It is not intended that the scope of the present invention be limited to the scope of the appended claims. [Brief description of the drawings]

[0022] [Figure 1] 1 shows a schematic diagram of an intravascular imaging and data collection system according to an exemplary embodiment of the present disclosure. [Diagram 2] 1 is a flow chart illustrating a framework for visualization of a stent in a side branch vessel according to an exemplary embodiment of the present disclosure. [Figure 3A] 1 is a schematic diagram illustrating virtual camera positions for visualizing a side branch vessel according to an exemplary embodiment of the present disclosure; [Figure 3B] 1 is a schematic diagram illustrating virtual camera positions for visualizing a side branch vessel according to an exemplary embodiment of the present disclosure; [Figure 3C] 1 is a schematic diagram illustrating virtual camera positions for an orthogonal view of a side branch ostium according to an exemplary embodiment of the present disclosure; [Figure 3D] 1 is a three-dimensional rendering of a stent strut restraining a side branch vessel ostium according to an exemplary embodiment of the present disclosure. [Figure 4A] 1 is a side view of a three-dimensional rendering of a main vessel having a side branch with a stent and multiple guidewires positioned within the main vessel, according to an exemplary embodiment of the present disclosure. [Figure 4B] 3B is a fly-through three-dimensional rendering of a side branch lumen with a virtual camera angle oriented along the longitudinal axis of the side branch as shown in FIG. 3A, according to an exemplary embodiment of the present disclosure. [Figure 4C] 3B is a fly-through three-dimensional rendering of a main vessel lumen with a virtual camera angle oriented along the longitudinal axis of the main vessel as shown in FIG. 3A, according to an exemplary embodiment of the present disclosure. [Figure 5A] FIG. 1 is a schematic diagram illustrating a virtual camera positioned using an intermediate frame / intermediate arc model according to an exemplary embodiment of the present disclosure. [Figure 5B] FIG. 1 is a schematic diagram showing a virtual camera positioned using a cylinder model. [Figure 6] FIG. 1 is a schematic diagram illustrating side branch size estimation according to an exemplary embodiment of the present disclosure. [Figure 7] FIG. 13 is a schematic diagram of displaying side branch location and color-coding the degree of side branch occlusion according to an exemplary embodiment of the present disclosure. [Figure 8] 1 is a user display showing a perspective view of a three-dimensional rendering of a blood vessel according to an exemplary embodiment of the present disclosure. [Figure 9A] 1 is a side view of a three-dimensional rendering of a blood vessel according to an exemplary embodiment of the present disclosure; [Figure 9B] 1 is a cross-sectional B-mode OCT intravascular image according to an exemplary embodiment of the present disclosure. [Figure 9C] 1 is a longitudinal L-mode OCT intravascular image according to an exemplary embodiment of the present disclosure. [Figure 10A] 1 is a side view of a three-dimensional rendering of a blood vessel showing a restrained side branch in accordance with an exemplary embodiment of the present disclosure; [Figure 10B] 1 is a cross-sectional B-mode OCT intravascular image according to an exemplary embodiment of the present disclosure. [Figure 10C] 1 is a longitudinal L-mode OCT intravascular image according to an exemplary embodiment of the present disclosure. [Figure 11A] 1 is a fly-through three-dimensional rendering of a blood vessel according to an exemplary embodiment of the present disclosure. [Figure 11B] 1 is a cross-sectional B-mode OCT intravascular image according to an exemplary embodiment of the present disclosure. [Figure 11C] 1 is a longitudinal L-mode OCT intravascular image according to an exemplary embodiment of the present disclosure. [Figure 12A] 1 is a fly-through three-dimensional rendering of a blood vessel showing a constrained side branch in accordance with an exemplary embodiment of the present disclosure. [Figure 12B] 1 is a cross-sectional B-mode OCT intravascular image according to an exemplary embodiment of the present disclosure. [Figure 12C] 1 is a longitudinal L-mode OCT intravascular image according to an exemplary embodiment of the present disclosure. [Figure 13-1] Figure 13A is a side view of a three-dimensional rendering of a blood vessel showing a released side branch according to an exemplary embodiment of the present disclosure, Figure 13B is a cross-sectional B-mode OCT intravascular image according to an exemplary embodiment of the present disclosure, and Figure 13C is a longitudinal L-mode OCT intravascular image according to an exemplary embodiment of the present disclosure. [Figure 13-2] FIG. 13D is an enlarged view of FIG. 13A showing the side branch ostium and split stent struts according to an exemplary embodiment of the present disclosure. [Figure 14A]1 shows a graphical user interface display of an intravascular data collection system illustrating a three-dimensional skin and wireframe view of a deployed stent according to an exemplary embodiment of the present disclosure. [Figure 14B] 1 shows a graphical user interface display of an intravascular data collection system illustrating a three-dimensional skin and wireframe view of a deployed stent according to an exemplary embodiment of the present disclosure. [Figure 14C] 1 shows a graphical user interface display of an intravascular data collection system illustrating a three-dimensional skin and wireframe view of a deployed stent according to an exemplary embodiment of the present disclosure. [Figure 14D] 1 shows a graphical user interface display of an intravascular data collection system illustrating a three-dimensional skin and wireframe view of a deployed stent according to an exemplary embodiment of the present disclosure. [Figure 14E] 1 shows a three-dimensional fly-through display of a wireframe view of a deployed stent according to an exemplary embodiment of the present disclosure. [Figure 15A] A user interface suitable for adjusting the apposition threshold, which in turn controls the threshold used by the intravascular data collection system when determining when to display apposition and indications / indicia (color, symbol, etc.) for use in accordance with exemplary embodiments of the present disclosure. [Figure 15B] A user interface suitable for adjusting the apposition threshold, which in turn controls the threshold used by the intravascular data collection system when determining when to display apposition and indications / indicia (color, symbol, etc.) for use in accordance with exemplary embodiments of the present disclosure. [Figure 15C]A user interface suitable for adjusting the apposition threshold, which in turn controls the threshold used by the intravascular data collection system when determining when to display apposition and indications / indicia (color, symbol, etc.) for use in accordance with exemplary embodiments of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0023] In part, the present disclosure provides a method for detecting side branches and detecting stent struts. The present invention relates to a system and method for visualizing intravascular data such as stent struts. Data can be acquired using a data acquisition probe. The probe is pulled back through the blood vessel. Such pullbacks and Relevant data collection is used to plan stent placement or evaluate the stent to be placed. The resulting intravascular data from the pullback is analyzed for various vessel regions, features, and These can be used in a variety of ways, such as to visualize a stent being placed in relation to the This can be done.

[0024] In various embodiments of the present disclosure, the stent can be visualized relative to the side branch. is an important feature because during stent placement, the side branch is typically stented. The systems and methods described herein are: Based on the detection of these features in the collected endovascular data, various user interface The representation of the stent struts and side branch is used to facilitate visualization of the stent within the side branch.

[0025] In part, this disclosure relates to the use of intravascular imaging modalities such as OCT, IVUS, and other imaging modalities. Data collection system, as well as stent malapposition or other The present disclosure relates to the generation and visualization of diagnostic information, such as a display of a stent in a stent-like configuration. Evaluate the degree of apposition and / or malposition. Identify parameters and thresholds of interest, such as thresholds or parameters used to The present invention relates to various user interface features that enable the user to Suitable for indicating diagnostic information of interest such as apposition level and stent position relative to the intraluminal region. You can adjust or change how and when such graphic elements are displayed. In this embodiment, the regions may include side branches that are detected. Caterpillar can also be used.

[0026] Suitable diagnostic information may include, for example, stent apposition information relative to the vessel wall or lumen boundary and other Including endovascular diagnostic information or other information generated to facilitate stent delivery planning. The system communicates with a graphical user interface and A processor configured to send instructions to a user interface. A software program was used to color-code the detected stent strut positions. Visual indicators such as stent struts or symbols or other markings, stent for side branches User-specified criteria for tent location and orientation, and when stent apposition is indicated Perform one or more of the stent apposition levels based on the criteria.

[0027] Also disclosed herein is a method for visually connecting stents and other medical devices to side branches. and avoiding their binding with the blood vessel. The module can be used to detect side branch locations, lumen contours, and stent strut positions. One or more viewing angles or orientations can be generated to allow the user to determine when side branch constraints may occur. This can help the user visualize the

[0028] A balloon-deployed stent to improve blood flow in a restricted side branch It may be necessary to open up a group of cells within the balloon guidewire. Cross the restrained side branch ostium as distally (e.g., downstream) as possible Obtaining the distal guidewire position involves pushing it proximal (e.g., upstream) of the side branch ostium. This results in stent struts that are inserted into the ostium of the side branch, which is more distal to the higher-flow Minimize flow disruptions at the distal side, thus reducing the risk of injury to the stent and side branch. Clear and rapid visualization of guidewire position is a clinical advantage.

[0029] FIG. 1 shows the detected stent struts, side branches, and guidewires and their associated Various aspects of the present disclosure, such as displaying associated indicia and orientation angles, may be used. The system includes a system adapted to perform the steps of: To this end, various user interface features are described herein. The interface is controlled by the user using a mouse, joystick, or other control device. and can be operated using one or more processors and storage devices. For example, the slides of FIGS. 15A to 15C may include one or more movable elements. The lidar can be controlled in this way.

[0030] During the stent delivery planning procedure, the level and location of apposition, the user can visualize the vascular With reference to angiography, the stent may be further expanded or moved as part of a delivery plan. These system features and methods can be implemented using the system 5 shown in FIG. can be done.

[0031] FIG. 1 illustrates a system for collecting data or detecting, sensing, or otherwise characterizing the condition of a subject 10. FIG. 5 shows a system 5 including various data acquisition subsystems suitable for diagnosing in the manner described above. In one embodiment, the subject 10 is seated at a table, bed, or chair or other suitable support. The subject 10 is positioned on a suitable support 12, such as a support body. Typically, the subject 10 is A human or other animal having a mind region 25.

[0032] The data acquisition system 5 may be a nuclear magnetic resonance, x-ray, computer-assisted tomography, or other suitable Such non-invasive imaging techniques include non-invasive imaging systems, such as As a non-limiting example of a system, suitable for producing cines may be provided. Such an angiography system 20 is shown. The angiography system 20 is a fluoroscopy system. The angiography system 20 may include a system for detecting blood vessels in a region 25 of the subject 10, e.g. For example, the angiogram may be imaged using one or more imaging techniques such as OCT or IVUS. To achieve this, image data is typically collected while a pullback procedure is being performed with the probe 30. The subject 10 is scanned so as to generate frames of angiographic data in the form of frames of data. The device is configured for non-invasive imaging.

[0033] Angiography system 20 is implemented as a workstation or server in one embodiment. The angiography system communicates with an angiography data storage and image management system 22 from which the images can be acquired. In one embodiment, data processing on the collected angiographic signals is performed by an angiographic system. The images from the system 20 are stored in an angiography data storage device. The images are stored and managed by the storage and image management system 22 .

[0034] In one embodiment, the system server 50 or workstation 85 is In one embodiment, the entire system 20 is configured to detect electromagnetic radiation, such as X-rays. The system 20 also receives such radiation after it has passed through the subject 10. Then, the data processing system 22 uses the signals from the angiography system 20 to calculate the area 25 One or more regions of the subject 10 are imaged, the region including

[0035] As shown in this particular example, the region of interest 25 may be a portion of the vasculature, such as a particular blood vessel, or a peripheral blood vessel. A subset of the vascular system that can be imaged using OCT. Catheters A data collection probe 30 based on the blood flow is introduced into the subject 10 and is placed in a specific location, such as a coronary artery. The probe 30 is placed in the lumen of a blood vessel. probe, IVUS probe, or a combination of features of two or more of the above mentioned probes. Various types of data, such as probes and other probes suitable for imaging in blood The probe 30 typically comprises a probe tip, one or more The probe tip includes a radiopaque marker, an optical fiber, and a torque wire. may be used as an optical beam director, an acoustic beam director, a pressure detection sensor, or other transducer or detector. The present invention may include one or more data acquisition subsystems, such as a data acquisition device, a data acquisition system, a data acquisition device ...

[0036] In the case of a probe including an optical beam director, the optical fiber 33 is provided with a beam director. The torque wire optically communicates with the probe through which the optical fiber is placed. In FIG. 1, the optical fiber 33 is shown without a torque wire surrounding it. In addition, the probe 30 includes a polymer sheath (not shown) that forms part of a catheter. In the context of an OCT system, it is the sample arm of the interferometer. The optical fiber 33 is connected to a patient interface unit (PIU) 35 as shown. Optically coupled.

[0037] A patient interface unit 35 receives and optically couples the end of the probe 30. Typically, the data collection probe 30 includes a probe connector adapted to be mated with the The PIU35 can be configured to run in a variety of configurations based on the type of data collection probe used. Includes appropriate joints and elements, e.g., OCT and IVUS data collection probe combinations. The combination requires OCT and IVUSPIU. The PIU35 is typically 33, in which the torque wire, sheath, and optical fiber are placed as part of the back procedure In addition to being retracted, the probe tip also includes a motor suitable for retracting the In this manner, the blood vessels of the subject 10 are rotated by the PIU 35. The probe 30 can be imaged either longitudinally or through a cross-section. It may be used to measure a specific parameter such as fractional flow rate (FFR) or other pressure measurements. It is also possible.

[0038] The PIU 35 is then connected to one or more intravascular data acquisition systems 40. The data acquisition system 40 may include an OCT system, an IVUS system, other imaging systems, and It may be a combination of the above. For example, in the context of probe 30 being an OCT probe. The system 40 in FIG. 1 includes a sample arm of an interferometer, a reference arm of an interferometer, and a photodiode. The device may include a patient interface unit, a control system, and a patient diode. Similarly, as another example, in the context of an IVUS system, an intravascular data acquisition system 40 The ultrasonic wave generating and processing circuit, the noise filter, the rotatable joint, and the motor In one embodiment, the data acquisition device may include a data acquisition unit and an interface unit. The data acquisition system 40 and the angiography system 20 acquire an angiography video frame time stamp. A shared clock or timestamps configured to synchronize the OCT image frame timestamps has other kinds of timing signals.

[0039] In addition to the invasive and non-invasive image data collection systems and devices of FIG. Collect various other types of data regarding area 25 and other parameters of interest to the subject. For example, the data collection probe 30 may include one or more It can include a pressure sensor on the pressure sensor without the need for additional OCT or ultrasound components. A wire may be used to apply pressure along a segment of a blood vessel in region 25 of subject 10. A force reading can be obtained.

[0040] Such readings may be relayed by a wired connection or via a wireless connection. As shown in the FFR data collection system, a wireless transceiver 47 is connected to the probe 30. It receives pressure readings from the The display 82, 83 is configured to generate more locations along the tube. 3. Angiography frames of data, OCT frames, OCT and angiography data A user interface for, and other controls and features of interest may also be presented.

[0041] endovascular data such as frames of endovascular data generated using the data collection probe 30 The image data is transmitted to a data acquisition and processing system 40 which is coupled to the probe via the PIU 35. The angiography system 22 can be used to generate the angiogram. The non-invasive image data is then stored in a co-registration server 50 (co-registration server) workstation. 85, and transmit, store, and transmit the information to one or more servers or workstations. The angiographic image data can be captured from the system 22 and processed by the A video frame grabber device 55, such as a computer board configured as follows: o frame grabber device) may be used in various embodiments.

[0042] In one embodiment, the server 50 includes a processor 80 that is configured to The server 50 includes one or more simultaneous recording software modules 67 executed by the , including other typical components for a processor-based computing server. Alternatively, the generated image data, the subject's parameters, and the Generated by one or more of the system devices or components and a database 90 or to receive other information that is transferred to the database 90. It is possible to configure more databases, such as Database 90. 90 is connected to the server 50 while being stored in memory in the workstation 85 Although shown as such, this is merely one exemplary configuration. The software module 67 can run on a processor in the workstation 85. In this case, the database 90 can be located in the memory of the server 50. For example, A device or system is provided that can be used to execute various software modules. The hardware and software described herein may be used in various combinations. obtaining a frame of image data, processing such image data, and You can register the data.

[0043] As otherwise referred to herein, the software module 67 processes the image data. or other software-based components 67 To facilitate simultaneous recording of different types of image data by a computer or to allow such simultaneous recording to be performed by another computer. Pre-processing software, transformations, matrices, and other software that respond to patient triggers to perform the method. A module can include software such as hardware-based components. Lumen detection using scanline-based or image-based approaches A multi-layer approach for stent detection, indicator generation, and alignment for stent planning Bar generation, guidewire shadow indicator to prevent confusion with dissection, side branches and missing data , as well as others.

[0044] Generated by the angiography system 20 and transmitted by the frame grabber 55 server 50 to receive and store angiographic image data 92, such as image data acquired by A database 90 can be constructed using the data generated by the OCT system 40 and the The OCT image data, such as the image data acquired by the frame grabber 55 server 50, The database 90 may be configured to receive and store data 95 .

[0045] In addition, the subject 10 is connected to one or more monitors, such as monitor 49, via one or more electrodes. The monitor 49 generates data regarding cardiac function and and an electrocardiogram monitor configured to indicate various states of the subject, such as systole and diastole. Blood flow, such as the geometry of the heart, including the coronary arteries, Knowing the cardiac phase, which can be used to aid in tracing the vascular centerline, is important even in different cardiac Even over the cycle, it is approximately the same at a particular cardiac phase.

[0046] Therefore, if the angiographic data span several cardiac cycles, the first-order Alignment may help track the centerline through pullback. Since most of the movement occurs during systole, vasomotion is higher near systole and lower toward diastole. This is expected to be attenuated by the amount of motion expected between successive angiographic frames. Provide data to one or more software modules as a representation of The software module uses knowledge of expected motion to set adaptation constraints based on expected movements. This improves tracking quality and vascular centerline quality.

[0047] The use of directional arrowheads, or the lack thereof, in a given figure limits the direction in which information can flow. For example, the elements shown in FIG. For a given connector, such as an arrow or a line, the information may include one or more directions appropriate for a given embodiment. Connections can be optical, wired, power, wireless, or electrical. Any suitable data transmission connection may be included, such as a data transmission connection.

[0048] One or more software modules may be used to perform an angiography system such as system 22 shown in FIG. The system may process frames of angiographic data received from an imaging system. , software, its components, or software-based or processor-based Various software modules that may include one or more steps of the method being performed. may be used in certain embodiments of the present disclosure.

[0049] Intravascular Data Visualization In one embodiment, to create optimal three-dimensional visualization for evaluating an endovascular treatment site. In various embodiments, the method comprises: Based on the results, the optimal camera location and view perspective are automatically determined. The method facilitates visualization of the position of medical devices (e.g., stents) and associated structures. This feature can include detection of a restrained device (e.g., a guidewire). The system identifies damaged side branches and allows clinicians to modify the stent tissue to relieve obstructions. It is particularly useful for bifurcation stenting, which aids in the stenting of bifurcated tissue. Use the software module 67 of the intravascular data acquisition system to perform the steps of In addition, the present invention relates to side branches, guidewires, and other forms of intravascular data visualization, as described herein. A variety of methods can be implemented.

[0050] Referring to FIG. 2, in one embodiment, a computer-implemented method 100 includes the steps of: Data collection steps, i.e., side branch detection 102, lumen contour detection 104, stent strut detection 1 06, and guidewire detection 108. Side branch detection and lumen detection include: determining an optimal viewing angle 110 based on the angle at which the side branch joins the main vessel; As described in more detail herein, these inputs can be used to To create a three-dimensional visualization of the treatment area, such as a fly-through display Different viewing angles may be used, including, but are not limited to, side view, oblique view, top view, side branch fly Side branch fly-through view, main vessel fly-through view This includes the orthogonal ostium view, the orthogonal ostium view, and the orthogonal ostium view.

[0051] Referring to FIG. 3A, in one embodiment, a virtual camera 150 captures one or more images of a blood vessel within a main blood vessel 154. A virtual camera is generated for the upper side branch 152. The virtual camera is used to view the side branch in 3D, looking towards the main vessel. Referring to FIG. 3B, one mode of operation is shown. In FIG. 3C, the camera orientation 156 is selected to be parallel to the longitudinal axis of the side branch. For reference, in other modes, the camera orientation 156 is perpendicular to the surface of the main blood vessel 154. These viewing angles are selected to be intersecting and / or perpendicular to the side branch opening 158. are exemplary and any suitable viewing angle may be used.

[0052] Referring to FIG. 3D, in another embodiment, the user may insert a stent across the side branch ostium 158. The constraining stent struts 160 can be visualized. The lateral branch ostium and the struts crossing it can be more clearly visualized by the user. In the same manner, the side branch can be removed from the display. A view is shown perpendicular to the ostium and through the ostium into the lumen of the main vessel where the stent will be placed.

[0053] FIG. 4A is a side view of a three-dimensional rendering of a main vessel 154 having a side branch 152. In this embodiment, a main vessel guidewire 164, a side branch guidewire 166, and a stent support Column 160 is visible.

[0054] FIG. 4B shows a three-dimensional view of the side branch 152 (e.g., fly-through) looking down toward the main vessel 154. In this embodiment, the camera 150b is a 3D rendering of the camera 150 as shown in FIG. The side branch guidewire 164 is oriented along the direction of the side branch angle. 166, and stent struts 160 are visible.

[0055] FIG. 4C is a three-dimensional fly-through of the main vessel 154. In this embodiment, the camera The 150m is oriented along the longitudinal axis of the main branch as shown in Figure 4A. Side branch guidewire 164, main vessel guidewire 166, and stent struts 160 are visible. do.

[0056] In various embodiments, the method includes automatically identifying an initial camera position. Referring to FIG. 5A, in one embodiment, imaging data (e.g., OC T data) and by finding the intermediate frame 170 and the intermediate arc position on the intermediate frame The intermediate frame 170 represents the side branch lumen in a given imaging frame. 172. Intermediate arc 174 is the center of an arc that defines a side branch lumen contour 176. In a preferred embodiment, the intermediate arc position is the initial camera position 178, i.e., the virtual camera Next, the initial camera orientation, i.e. the direction the virtual camera is aimed at, is set. In a preferred embodiment, the camera automatically selects the location of the intermediate frame. 17. The imaging catheter 180 is then oriented toward the clinician to guide the side branch lumen 172 down the side branch lumen 172 for imaging. 182. However, the camera can be rotated in any direction to provide a view toward the main vessel lumen 182. Can be directed.

[0057] Referring to FIG. 5B, in another embodiment, a cylinder 184 may be fitted into the side branch lumen 174. The camera position is then determined by the circular arc of the side branch lumen contour. The arc of the ray path 184 is used to estimate the side branch orientation 186. 178 is positioned along the axis of the side branch 186. Next, the initial camera orientation is automatically selected. In a preferred embodiment, the camera is positioned down the cylinder axis 186 into the main vessel lumen 182. However, you can point the camera in any direction. can.

[0058] The present disclosure provides a method and apparatus for displaying medical devices such as guidewires and stents on a user display. A computer-implemented method for enhanced visualization is provided. The enhanced visualization is The physician will assess the treatment site adjacent to the placed medical device to determine if further intervention is required. For example, it helps assess whether the guidewire is inside the stent (i.e., the lumen) or inside the stent. It is particularly important for clinicians to understand when the stent is positioned on the outside (i.e., abluminal) side. As another example, balloons can be used to improve blood flow in restricted side branches. It is often necessary to open up a group of cells within a stent that has been placed using a balloon gun. The guide wire is typically attached to the side branch ostium, which is constrained as distally (e.g., downstream) as possible. Obtaining the distal guidewire position involves crossing the proximal (e.g., upstream) side of the side branch ostium. This results in the stent struts being pushed in, which in turn reduces the flow distal to the larger flow volume of the side branch ostium. Minimize low interference.

[0059] Stent struts and guidewires are automatically detected in the imaging data and displayed to the user. The stent struts and guidewires are shown above, providing the clinician with comprehensive visualization of the treatment site. The ears may be visually distinct, such as by using different colors, to provide clinicians with In one embodiment, the guidewire can be a stent. The endoluminal / extraluminal location of the target can be shown in different colors according to its location relative to the target. Extraluminal guidewires can be displayed in red as a warning and endoluminal guidewires in yellow. This visualization helps define the point at which the guidewire crosses the constrained side branch. This can prevent the guidewire from being inadvertently positioned outside the lumen of the stented section of the main branch. It can also be useful to make users aware. In other embodiments where multiple guidewires are used, the guidewires each have: The guidewires may be shown in different colors, or the guidewires may be classified by color. For example, , the side branch guidewire may be shown in one color and the main vessel guidewire in another color. In another embodiment, the guidewire may be inserted into the main vessel lumen. Can be shown in one color, and the portion of the same guidewire that crosses the side branch can be shown in a different color In other embodiments, when the guidewire crosses the side branch ostium or when the guidewire is stuck The guidewire may be shown in a different color as it passes through tented cells.

[0060] Similarly, the struts were used to indicate potential problems, such as struts restricting the side branches. Some or all of the stent struts and / or stent struts may be shown in different colors. For example, Struts crossing the side branch ostium can be shown in red, whereas struts adjacent to the vessel wall can be shown in red. The rats can be shown in blue.

[0061] In another embodiment, visual indicia such as a highlighted polygon around the edge of the side branch ostium may be used. The visual markers are one for each unobstructed lateral branch ostium. color for the occluded side branch ostium and can be other colors.

[0062] Stent struts are also color-coded to clarify their position relative to the virtual camera. 4A to 4C show how the stent is positioned relative to the main vessel wall. It is difficult to understand which stent is placed over the side branch ostium versus which stent is placed over the side branch ostium. However, referring to FIG. 3B, the individual struts and the inner lumen of the vessel can be seen to be self-aligned. Following dynamic detection, there is less correlation between visualization of wire re-crossings. Should trout be assigned a de-emphasizing color such as gray or white? Or they can be removed altogether, whereas more relevant side branches are constrained. Struts can be assigned a highlight color, such as red.

[0063] Color is just one example of a visual indicia that may be used in accordance with the disclosure. For example, an indicia may be , a bar, a box, or any other suitable visualizable display element, symbol, or icon. Preferably, the indicia may be, for example, color coded, shaded, and / or have variable opacity. This quantitatively determines the degree of any side branch occlusion.

[0064] Assessment of side branch occlusion The present invention is a computer-based method for calculating and visualizing the degree of branch obstruction. Methods of implementation are also provided. Several methods can be used to calculate the resulting branch cutoff.

[0065] In one embodiment, the reference vessel diameter method is used to determine side branch obstruction. FIG. 6 shows a main blood vessel 200 having a stenosis 202. A side branch 204 is also shown. A baseline profile can be created for the main vessel 206 and / or the side branch. A reference profile can be created for 208. Reference Profile (Dotted Line) 208 If we use the distal and proximal reference profiles, the branch estimated by using the distal and proximal reference profiles The diameter can be calculated. In one embodiment, the power law is given by the following formula: do.

number

[0066] The difference between the estimated branch diameter and the actual branch diameter detected by OCT imaging was considered to be the branch occlusion. In one embodiment, the level of branch occlusion is given by the formula: can be obtained.

number

[0067] In one embodiment, the maximum diameter frame method is used to assess side branch occlusion. Instead of using a file, the best fit in the main vessel segments distal and proximal to the current branch is used. The major diameter is used to estimate branch diameter.

[0068] In one embodiment, a flow method is used to assess side branch occlusion. If you use a Flow Reserve (VFR), you can estimate the flow entering each side branch. OCT-based branch diameter flow OCT (i) and true branch diameter Flow b Between (i) and The difference in flow down a given branch due to a difference in Reference vessel profiles in the distal and proximal segments. or by using one of the above methods by using a second diameter frame. The true branch diameter can be calculated using the flow method, given by the following equation:

number

[0069] In various embodiments, visual indicators, such as color coding, may be used to indicate to the user that a side branch flow obstruction has occurred. The indicia can be coded to give the level of side branch occlusion. These marks can also be set based on user input via the user interface. FIG. 7 is a schematic diagram of an exemplary user display. The display includes a stenosis 202. The diagram shows a main blood vessel 200 with three side branches 210, 212, and 214. The blocked side branch 212 is shown in FIG. 11A, which is a cross section of the moderately blocked side branch 210 (e.g., orange) and the low blocked side branch 211 (e.g., orange). / Identified by a different marking (e.g., red) from the unoccluded side branch 214 (e.g., yellow). It can be seen.

[0070] FIG. 8 is a perspective view of a three-dimensional rendering of a blood vessel 300 according to one embodiment. The display shows a guidewire 302, a stent strut 304, and a restrained Markings defining the inserted side branch 306 are visible. The user display shows the guidewire / A menu 310 for hiding and a menu 31 for selecting blood vessel features to be displayed. 2 and a menu 314 for selecting the virtual camera angle of the display. The user can switch between multiple viewing angles on the display. For example, by selecting a particular side branch and / or associated with a particular side branch, By selecting the camera, the user can switch between different side branches on the display. This can be done.

[0071] 9A-9C show a side view of a three-dimensional rendering (FIG. 9A), a corresponding B-mode OC A lateral view of the L-mode OCT image (Figure 9B) and the corresponding L-mode OCT image (Figure 9C) are integrated. FIG. 9A shows a side view of a three-dimensional rendering of a blood vessel 300. The guidewire 302 and stent struts 304 are visible. The CT image shows a guidewire shadow 312 and multiple stent strut shadows 314. The guidewire shadow 3 is clearly visible. Figure 9C shows a longitudinal L-mode OCT image. 12 and multiple stent strut shadows are clearly visible. Define the frame.

[0072] 10A to 10C are three-dimensional renderings of the side view ( FIG. 10A), the corresponding B-mode OCT image (FIG. 1B), and the corresponding L-mode OCT image. (FIG. 10C) shows the user display. It includes visible markings 306 that define the branches.

[0073] 11A-11C show a fly-through rendering (FIG. 11A), the corresponding B-mode The OCT image (Fig. 11B) and the corresponding L-mode OCT image (Fig. 10C) were merged into a single image. In FIG. 11A, the guidewire 302 and the stent support are shown. A pillar 304 is shown in the space-filling model. A compass 320 indicates the proximal and distal directions. The arrows indicate the position direction.

[0074] 12A-12C show a similar display as shown in FIG. FIG. 12A includes indicia of a constrained side branch 306 according to an exemplary embodiment. .

[0075] 13A-13C are side views of three-dimensional renderings similar to FIGS. 9A-9C. (Figure 13A), the corresponding B-mode OCT image (Figure 13B), and the corresponding L-mode OCT FIG. 13A shows the user display, which is integrated with the image (FIG. 13C). However, the occlusion was relieved by cutting the stent struts 324 that restrained the side branch. FIG 13D is an enlarged view of FIG 13A showing the side branch ostium 322 and the cleft. 3 shows a cleaved strut 324.

[0076] Exemplary Intravascular Data Collection Embodiments The systems and methods described herein may be used to treat other complex disorders such as tandem / diffuse disease. Pre- and post-intervention data with specific clinical applications for branching, BVS, and VFR for complex conditions Provide diagnostic information to assist with imaging needs. These embodiments include the following features. ● 3D options for fly-through, longitudinal and branch views Use of OCT for BVS procedural considerations and stent detection ● Ultra-high resolution pullback for branching cases ● Multiple 3D display options plus independent wire selection in 3D Stent apposition mapping indicator; added status bar for 360 degree evaluation ● Collocated red / yellow indication ranges and the ability to customize those ranges ● Various user interface design elements

[0077] FIG. 14A shows a three-dimensional skin and wire image of a placed stent based on OCT imaging data. FIG. 1 shows an interface display illustrating the Yaframe view. The top left panel shows , which shows a front view of a blood vessel. Specifically, the intraluminal boundary of the blood vessel is shown in three figures as a translucent skin. The skin is depicted in three dimensions. The skin is depicted in three dimensions, depicting the topography of the vessel wall and / or vessel lumen along the region of interest. In a preferred embodiment, the skin is divided into collaterals, healthy endothelium, narrowing, and To enhance user visualization of vascular topography, such as narrowings, lesions, and plaques; The skin may be depicted in any suitable color, and is preferably Often, the stent is translucent to allow visualization of the stent positioned within the lumen.

[0078] As with other user interfaces, the double arrows allow the user to rotate the skin view. As shown in FIG. 14A, in some embodiments, the skin itself can be as thick as (i.e., it is two-dimensional) and only defines the intraluminal boundary in three dimensions. In an embodiment, the skin has a nominal or substantial thickness to enhance feature visualization. To enhance the overlay of features such as stent struts, the lumen, skin or other layers may be The transparency level of the side branch detection can be adjusted as shown in Figure 14B. The system is enhanced with a three-dimensional interface to support the use of 3D models as well as input to VFR calculations.

[0079] With continued reference to FIG. 14A, the top left panel shows the wire behind or inside the translucent skin. Shows the deployed stent as a frame graphic. The side branch ostium is a perforation or The stent struts are visible through the translucent skin. Further information regarding stent placement and positioning may be provided by color or other visual indicators. For example, it is possible to provide a single color (e.g., white) for the appropriately positioned posts. Indicated poor apposition (major inadequate apposition) (e.g., insufficient expansion, restricting side branches, etc.) The columns are shown in different colors (e.g., red) for proper alignment and white for potential juxtapositions. A color gradient such as yellow for possible stent apposition and red for possible stent apposition allows for stent placement. The degree or extent of juxtaposition can be conveyed. Use different colors to distinguish between causes and associated juxtaposition levels or thresholds. For example, in one embodiment as shown in Figures 15A-15C, These thresholds can be set using one or more software interfaces. Using the module 67 to implement the software and control device to display the markings. can be done.

[0080] As a non-limiting example, a stent strut that is properly expanded against the vessel wall may be colored with one color (e.g., In this study, the authors showed the inflated struts in a different color (e.g., white) while the inflated struts were shown in a different color (e.g., purple). Further intervention may be required to fully expand the stent in certain locations. Similarly, the user may be warned that the struts may be further restrictive or obstructive to the lateral branch ostium. Show the potentially constrained struts in another color (e.g., red) and the potentially constrained struts in yet another color (e.g., yellow). to alert the user that adjustment or repositioning of the stent may be required. As will be appreciated, for example, patterned lines, hatching and shading may be used. Other visual cues can be used, such as

[0081] The top right panel of FIG. 14A shows a cross section of an OCT image. The cross section of a stent strut is a circle. The stent supports are depicted as The pillars can be indicated by color or other visible markings, e.g., appropriate for the vessel wall. The fully expanded stent struts are shown in one color (e.g., white), whereas the side branch restraints are shown in one color (e.g., white). The support pillars are shown in another color (e.g., red).

[0082] The center panel of Figure 14A shows a longitudinal or L-mode rendering of the OCT data. The cross-section frame corresponds to a vertical line within the region of interest. The bottom panel of FIG. 14A shows the alignment. The wireframe representation of the stent and the simultaneously recorded OCTL mode image of the vessel are shown. Again, the stent struts that were properly expanded against the vessel wall were placed in a single color (e.g. , white), whereas struts that constrain the side branches are shown in another color (e.g., red).

[0083] FIG. 14C shows a three-dimensional skin and wire image of a placed stent based on OCT imaging data. 1 shows an interface display illustrating a user frame view. The play displays one or more features, such as skin, a guidewire, and / or a stent strut. In addition, you can change the skin color and transparency. In addition, the skin can be made more transparent or opaque.

[0084] FIG. 14D illustrates a three-dimensional skin and wireframe view of a deployed stent. Fly-through display showing distal (D) or downstream and proximal (P) or superior The interface display shows the location of a cross-sectional image within the region of interest. The interface display may also include a location marker indicating the location of the blood vessel. Further includes a lumen marker that highlights the lumen border / contour to make the graphics clearer. It is possible.

[0085] FIG. 14E is a milling cutter illustrating a three-dimensional wireframe view of a deployed stent. In this embodiment, the skin is not shown, just the stem. In some situations, when the skin is not present, Stent apposition may be more evident. A three-dimensional view of the lumen along the length of the vessel. The skin can be turned on and off as part of the 3D fly-through.

[0086] User interface features for collocation levels The process of establishing a stent apposition value, such as an apposition threshold, may be performed by one user of the intravascular diagnostic system. The end user may differ from other end users. 15B, and 15C. In FIG. 15A, a user button for adjusting the stent apposition value is provided. The interface is presented to the graphic user interface of the OCT system. This interface can be used for IVUS and other imaging modalities. The stent struts, shown in dotted lines, may have one or more surface or stripe shaped features as alterable features. It has an arrow that can extend to the tent pole, which is a good idea because the juxtaposition is interesting to the user. 15A and 15B, which allow the location of the support to be identified as a location on or within the support. In FIG. 15B, the three levels or thresholds for scoring or identifying the juxtaposition level are: 0 to 200 microns, 200-300 microns, and 300-600 microns. As shown in 15B, the three colored bars shown allow three juxtaposition thresholds to be set. These thresholds control how and when stent apposition is indicated. The pillar apposition distance is indicated by the double-headed arrows in the figures for the stent struts and lumen contour. .

[0087] The lumen contour is the detected or calculated boundary of the lumen of a blood vessel. The struts are close to the lumen contour. The strut alignment ensures that the front of the strut is a known distance from the lumen contour. To the extent that the device indicates this, end users may use their knowledge of the thickness of the stent to It is possible to set the alignment threshold to meet the needs of each individual. The alignment threshold is as shown in FIG. Only two levels - juxtaposed or non-juxtaposed can be set. You can set two, three, or more such levels. In one embodiment, as shown in Figures 15A and 15B, a graphic representation of the stent struts is shown. Adjust the slider bar to align the three indicators so that they are used to correct the The term apposition refers to the extension of the vascular wall to the or to be used to describe the degree to which a stent deviates from a preferred level of placement. This may include significant malapposition.

[0088] by a juxtaposition threshold to evaluate the detected stent struts against the detected lumen contour. The level of such stent malapposition can be defined using a user interface. The interface may be a slider (as shown in Figures 15A-15C) or a toggle. Control, one or more buttons, percentage or distance of other juxtaposition parameters or Field for the trial, or the stent strut and stent strut apposition level where the mark was detected Other users, such as other interfaces, specify how the The interface may be any suitable user interface for selecting or inputting the juxtaposition threshold. In one embodiment, the apposition is achieved by using a stent support. The thickness of the struts is not specified, but rather the stent strut end surface is used. The authors were able to adjust the threshold based on their expertise and the thickness of the stent struts in use. can.

[0089] Non-limiting software features and methods that implement the interfaces, detection, and other features of the disclosure. and embodiment The following description is of device hardware suitable for carrying out the methods disclosed herein. This description is intended to provide an overview of the software and other operating components of the disclosed Similarly, the hardware and other The operating components may suitably be part of the above mentioned devices. computers, multiprocessor systems, microprocessor-based or programmable Child devices, network PCs, minicomputers, mainframe computers, and Other system configurations, including equivalents, may be used to implement the present disclosure. Remote locations linked through a communications network, such as different rooms in a telecommunications system or catheterization lab. The present disclosure may also be practiced in a distributed computing environment in which remote processing devices are executing the computing environment. It is possible.

[0090] Some parts of the detailed description are operations on data bits in computer memory. Methods such as algorithms and symbolic representations of the arithmetic operations are presented. Algorithmic descriptions and representations may be readily understood by those of ordinary skill in the computer and software related arts. In one embodiment, the algorithm may be used as described herein in general terms. The method steps are conceived to be a self-consistent sequence of operations that result in or operations performed as otherwise described herein, It involves physical manipulation of physical quantities. Usually, but not necessarily, these quantities can be stored. be processed, transferred, combined, transformed, compared, and otherwise manipulated; This takes the form of an electrical or magnetic signal that can be

[0091] Unless otherwise stated, and as will become apparent from the following discussion, the term "processing" is used throughout this description. " or "calculate" or "search" or "display" or "detect" or "measure" "Calculate" or "Compare" or "Generate" or "Detect" or "Determine" Such as "display" or "display" or Boolean logic or other set related operations or the like. The discussion utilizing the term refers to the operations performed within the registers and memory of a computer system or electronic device. manipulate data represented as physical (electron) quantities and store them in electronic memories or registers or Other such information may similarly be represented as physical quantities in other such information storage, transmission, or display devices. refers to the actions and processes of a computer system or electronic device that converts data into .

[0092] The present disclosure, in some embodiments, also relates to apparatus for performing the operations herein. The apparatus may be specially constructed for the required purpose or the apparatus may be computer-implemented. Selectively activated or reconfigured by a stored computer program Various circuits and components thereof may be used to implement the functions and operations described herein. The system can perform some of the data collection, conversion and processing described above.

[0093] The algorithms and displays presented herein may be implemented in any particular computer or The present disclosure is not inherently related to any other device. Various general purpose systems may be programmed in accordance with the teachings herein. The method may be performed in conjunction with a RAM or may be more specialized to perform the required method steps. It may prove convenient to construct an apparatus that The required structure for this will be apparent from the description provided herein. The present invention is not described with reference to any particular programming language, and therefore various programs may be used. Various embodiments may be implemented using a programming language. The software instructions are implemented by the microprocessor or AS of the intravascular imaging / data acquisition system. Configured for operation on an IC.

[0094] Embodiments of the present disclosure include, but are not limited to, a processor (e.g., a microprocessor processor, microcontroller, digital signal processor, or general purpose computer ) for use with computer-programmed logic, programmable logic devices (e.g., Field Programmable Gate Arrays (FPGAs) or other PLDs) Program logic, discrete components, integrated circuits (e.g., application specific (ASIC), or any other means including any combination thereof. The invention may be implemented in many different forms.

[0095] In exemplary embodiments of the present disclosure, OCT probes, IVUS probes, and other imaging probes may be used. lobes, angiography systems, and other imaging and subject monitoring devices and processes Part or all of the processing of data collected using a computer-based system may be computer-based. The program may be converted into an executable form, stored as such in a computer readable medium, and A computer program executed by a microprocessor under the control of an operating system. This is implemented as a set of program commands. So, for example, pullback or co-registration requests Completion-based user interface commands and triggers generate OCT data and A processor suitable for performing image processing using various and other features and embodiments of the present invention. The command is converted into understandable instructions.

[0096] In addition, the user interface instructions, user queries, and system responses described herein Responses, transmitted probe data, input data and other data and signals are transmitted to the user interface. a graphical user interface for controlling the graphic signal processing in response to the selection of the graphical user interface; It controls the processing and collects cross-sectional information, rendered stents and guidewires, and other data. Display images from multiple modalities and generate stents, apposition bars, and other endovascular data and display, OCT, angiography, detect shadows, peaks and graphics. The user interface and other features and other aspects of the embodiments described above may be modified in any manner. The data is converted into processor understandable instructions suitable for retrieving the data. components or controls, as values ​​or in a graphical user interface Data and parameters suitable for display as other representations include guidewires, apposition bars, The interface panel, mask, stent strut, missing data representation, shading, vessel Contrast representations, 3D and 2D renderings and views, and other features described herein. Including, but not limited to, symptoms.

[0097] Computer program logic implementing all or part of the functionality previously described herein. The Software may be provided in source code form, computer executable form, and various intermediate forms (e.g., assembly The form generated by the assembler, compiler, linker, and locator The present invention may be embodied in various forms, including, but not limited to, source code. provides various programming languages ​​for use with various operating systems or operating environments. programming language (e.g., object code, assembly language, or Fortran, C, C ++, JAVA, or a high-level language such as HTML The source code may include computer program instructions. Source code may define and use messages (e.g., via an interpreter). The source code may be in computer executable form (e.g., Convert the program into a computer-executable form (through an instulator, assembler, or compiler) It is okay to do so.

[0098] Computer programs are stored in semiconductor memory devices (e.g. RAM, ROM, PRO M, EEPROM, or Flash programmable RAM), magnetic memory devices (e.g. diskette or fixed disk), optical memory devices (e.g., CD-ROM), P Tangible storage, such as a C card (e.g., PCMCIA card), or other memory device In any form (e.g., source code form, computer The computer program may be fixed in a program form (executable or intermediate form). These include, but are not limited to, analog, digital, optical, wireless technologies (e.g., bluetooth, (registered trademark), network technology, and internetworking technology. Any form of signal that can be transmitted to a computer using any of a variety of communication technologies, including The computer program may be stored in (for example, system ROM or fixed disk) Preloaded into a computer system (e.g., on a disk) or a communication system (e.g., Distributed from electronic bulletin boards or servers over the Internet or the World Wide Web removable with printed or electronic documentation (e.g. shrink-wrapped software) The information may be distributed in any form, such as a storage medium.

[0099] Implementing all or part of the functionality described herein (eg, programmable logic devices) Hardware logic (including programmable logic for use with the They may be designed using manual methods such as computer-aided design (CAD), hardware Hardware description language (e.g., VHDL or AHDL), PLD programming language (e.g., Electronically, using various tools such as PALASM, ABEL, or CUPL It may be designed, captured, simulated, or documented.

[0100] Programmable logic is a semiconductor memory device (e.g., RAM, ROM, PRO M, EEPROM, or Flash programmable RAM), magnetic memory devices (e.g. a hard disk (e.g., diskette or fixed disk), an optical memory device (e.g., CD-ROM), or may be permanently or temporarily fixed to a tangible storage medium, such as other memory devices. Programmable logic may include, but is not limited to, analog technology, digital technology, , optical technology, wireless technology (e.g., Bluetooth), networking technology, and internetworking technologies, The programmable logic may be fixed in a signal that can be transmitted to a computer. Preloaded into a computer system (on a system ROM or fixed disk) or via electronic bulletin boards or communication systems (e.g., the Internet or World Wide Web) The document is distributed from a server, either printed or electronic (e.g., shrink-wrapped software) (a) may be distributed as a removable storage medium.

[0101] Various examples of suitable processing modules are described in more detail below. When a module is used, it is a piece of software suitable for performing a particular data processing or data transmission task. In one embodiment, the module The rule can be used to enter commands or angiography data, OCT data, IVUS data, offsets, shadows, etc. Shadow, pixel, intensity pattern, guidewire segment, side branch orientation, stent orientation, side branch position stent position relative to the patient, user interface data, control signals, angiography data, user Laser operation, frequency, interferometer signal data, detected stent, candidate stent strut, I VUS data, shadows, pixels, intensity patterns, scores, projections, and guidewire data, as well as The system may receive and modify various types of data, such as other information of interest as described herein. Suitable software routines, programs, or other means for converting, routing, and processing refers to other memory resident applications.

[0102] The computers and computer systems described herein acquire and process data. storing software applications used to access, store and / or communicate The method may include a computer-readable medium, such as a memory, in operable association with the method. Such memory is internal to the computer or computer system with which it is operatively associated. It will be appreciated that the location may be internal, external, remote or local.

[0103] The memory may be, for example, but not limited to, a hard disk, an optical disk, a floppy disk, etc. ) discs, DVDs (digital versatile discs), CDs (compact discs), memory Stick, flash memory, ROM (read only memory), RAM (random access memory) access memory), DRAM (Dynamic Random Access Memory), PROM (Programmable ROM) programmable ROM), EEPROM (extendable erasable programmable ROM), and / or other equivalent Includes any means for storing software or other instructions, including a computer readable medium. That's fine too.

[0104] Generally, computer readable media applied in connection with the embodiments of the disclosure described herein The memory medium is any medium capable of storing instructions that are executed by a programmable device. Where applicable, the method steps described herein may include a computer-implemented memory medium. The present invention may be embodied or implemented as instructions stored on a computer-readable storage medium or a storage medium. These directives may be applied to create directives in accordance with embodiments of the present disclosure. ++, C, Java, and / or various other types of software programming languages. The software may be embodied in a variety of programming languages ​​such as:

[0105] The terms “machine-readable medium” or “computer-readable medium” refer to any medium that is executable by a machine. The set of instructions of the present disclosure may be stored, encoded, or carried on a machine. The machine-readable medium includes any medium that causes any one or more of the methodologies described herein to be performed. Although illustrated in the exemplary embodiment as a machine-readable medium, the term "machine-readable medium" is understood to include A medium or multiple media (e.g., a database, one or more centralized or distributed databases and / or associated caches and servers) This must be understood as follows.

[0106] The storage medium may be non-transitory or may include a non-transitory device. A non-transitory storage medium or device may include a device that is tangible, means that a device has a concrete physical form, but the device is not limited to its physical state. Thus, for example, non-transients remain tangible despite this change in state. Refers to a device.

[0107] The aspects, embodiments, features, and examples of the present disclosure are to be considered in all respects illustrative. and are not intended to limit the disclosure, the scope of which is defined only by the claims. Other embodiments, modifications, and applications are within the skill of the art without departing from the spirit and scope of the claimed invention. It will be clear to those who

[0108] The use of headings and sections in this application is not meant to limit the invention. Each section may apply to any aspect, embodiment, or feature of the claimed invention.

[0109] Throughout this application, compositions are described as having, including, or containing particular components. or a process is described as having, including, or comprising certain process steps. Where indicated, the compositions of the present teachings consist essentially of or consist of the recited components. and the process of the present teachings consists essentially of the recited process steps. It will be understood that the term may consist of or consist of.

[0110] In this application, the elements or components may be listed in the list of elements or components. When a statement is made that an element or component is included in and / or selected from An item can be any one of the listed elements or components. and selected from the group consisting of two or more of the listed elements or components. It should be understood that, furthermore, nothing herein, expressly or implicitly Any of the elements and / or features of the compositions, devices, or methods described herein may be incorporated by reference in any manner in accordance with the present teachings. It is understood that the present invention may be combined in various ways without departing from the spirit and scope of the present invention. I want to be.

[0111] "include", "includes", "including", "has" The use of the terms "have," "has," or "having" is expressly Unless otherwise noted, it should be understood to be generally open ended and non-limiting.

[0112] The use of the singular herein includes the plural (and vice versa) unless specifically stated otherwise. Moreover, the singular forms "a," "an," and "the" are used interchangeably unless the context clearly dictates otherwise. In addition, the use of the term "about" before a quantitative value does not specifically indicate Unless otherwise specified, the present teachings also include the specific quantitative value itself. refers to a ±10% variation from the nominal value.

[0113] The order of performing certain actions or ordering of steps may be varied so long as the present teachings remain operable. Moreover, it should be understood that two or more steps or actions may be performed simultaneously. The examples provided herein are intended to illustrate potential specific implementations of the present disclosure. These examples are intended primarily for purposes of illustrating the teachings of those skilled in the art. It will be understood that, without departing from the spirit of this disclosure, There may be variations to these diagrams or the operations described herein. For example, in certain cases: The method steps or operations may be performed or executed in differing order or operations may be may be added, deleted or modified.

[0114] Where ranges or lists of values ​​are provided, the upper and lower limits of those pairs of ranges or lists shall be 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 invention. Smaller ranges are contemplated and are encompassed by the present invention. A list of exemplary values ​​or ranges is given. This does not exclude other values ​​or ranges between and including the upper and lower limits of the range.

[0115] Furthermore, the specific embodiments of the present disclosure are not intended to be limiting of the present disclosure but are illustrative of the present disclosure. Although described herein for purposes of illustration, the elements, steps, structures, and / or components may be Numerous variations in details, materials and arrangements may depart from the present disclosure as claimed. It will be understood by those skilled in the art that the present invention may be practiced without departing from the principles and scope of the present disclosure. There will be.

[0116] Moreover, specific embodiments of the present disclosure are described herein for the purpose of illustrating the present disclosure. Although not described by way of limitation, elements, steps, structures, and / or components Numerous variations in details, materials and arrangements may be made in the present disclosure without departing from the disclosure as set forth in the claims. It will be understood by those skilled in the art that the present invention may be practiced within the principles and scope of the teachings.

[0117] The claims are as follows:

Claims

1. 1. A method for visualizing intravascular information obtained using an intravascular data collection probe, comprising: receiving endovascular data for a blood vessel, the endovascular data including a plurality of image frames; storing the intravascular data in a memory device of the intravascular data collection system. P and detecting one or more side branches per image frame; detecting the lumen for each image frame; determining a first viewing angle for at least one of the side branch or the lumen; displaying a three-dimensional visualization of at least one of the side branch or the lumen; The method comprising:

2. The method of claim 1 , wherein the lumen is a lumen boundary.

3. Displaying a three-dimensional fly-through for at least one of the side branch or the lumen. The method of claim 1 further comprising:

4. The method of claim 1 , wherein the intravascular data is optical coherence tomography data.

5. The method of claim 4 , wherein each image frame comprises a set of scan lines.

6. The method of claim 1 , further comprising the step of detecting a plurality of stent struts.

7. The method of claim 1 , further comprising the step of detecting one or more guidewires.

8. 4. The method of claim 3 further comprising determining a second viewing angle for the plurality of stent struts.

6. The method according to claim 6.

9. 4. The method of claim 3 , further comprising determining a third viewing angle for the one or more guidewires.

7. The method according to claim 7.

10. The method of claim 1 , wherein the three-dimensional visualization is oriented at the first viewing angle.

11. The three-dimensional fly-through is user controlled in one or more directions using an input device. The method according to claim 3, wherein

12. determining a side branch arc of the lumen contour; Estimate the side branch orientation by fitting a cylinder constrained by the side branch arcs Steps and selecting a cylinder orientation to be matched; The method of claim 1 further comprising:

13. determining an intermediate frame of the image frames of the intravascular data; and determining an intermediate arc on the intermediate frame; determining a position and orienting the intravascular imaging probe for said intermediate frame; The method of claim 1 further comprising the step of setting an initial camera position for the three-dimensional view. method.

14. A processor-based system for controlling a stent apposition threshold based on user input. So, one or more memory devices; a computing device in communication with the one or more memory devices; comprising The one or more memory devices are operable by the computing device. instructions to the computing device to: User interface including stent strut apposition threshold control including user selectable input Display the storing a user-entered stent strut apposition threshold in one or more memory devices; Detecting one or more stents within an intravascular data set acquired using an intravascular probe Let, displaying one or more stents and one or more indicia associated with the one or more stents; indicates the level of stent strut apposition determined using the user selectable inputs. A system

15. The method of claim 14 , wherein the stent strut apposition threshold control is a slider.

16. 16. The method of claim 15, wherein the user selectable input is one or more values ​​of the slider. method.

17. The method of claim 14 , wherein the indicia is one or more colors.

18. The method of claim 15 , wherein the slider is configured to define three juxtaposition thresholds. 。

19. The stent strut apposition threshold control measures stent strut apposition relative to the front surface of the stent strut. The method of claim 1, wherein

20. The stent strut apposition threshold control includes a form fillable field, a button, and a toggle.

2. The method of claim 1, wherein the input is selected from the group consisting of a dial control, a dial, and a numerical selection input. How to.

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