Angiographic image / video synchronization and angiographic delay measurement using pullback

Abstract

One or more devices, systems, methods, and storage media for optical imaging medical devices, such as optical coherence tomography (OCT), single mode OCT, and / or multi-modal OCT apparatus and systems, and methods and storage media for use therewith, are provided for displaying, controlling, updating, and enhancing imaging modalities, performing angio-delay determination to find relative delay differences between angio-images and other modality images, and / or performing synchronization techniques.SOLUTION: Embodiments provide at least one intuitive graphical user interface (GUI), method, apparatus, device, system, or storage medium for capturing information, improving or maximizing accuracy in one or more images, determining an angiographic delay (or delay time), and / or performing synchronization. The GUI can function for one or more applications such as angio delay measurement, synchronization, co-registration, imaging, etc.SELECTED DRAWING: Figure 4A

Description

[Technical Field]

[0001] The present disclosure relates generally to the field of computational and / or optical imaging, and more particularly to devices / apparatus, systems, methods, and storage media for performing image / video synchronization and delay measurement using pullback and / or using one or more imaging modalities (such as angiography, optical coherence tomography (OCT), multi-modality OCT (MM-OCT), near-infrared fluorescence (NIRF), near-infrared autofluorescence (NIRAF), OCT-NIRAF, robotic imaging, snake-like robotic imaging, etc.). Example OCT applications include imaging, evaluation, and diagnosis of biological objects, such as gastrointestinal, pulmonary, cardiac, ophthalmic, and / or intravascular applications, and acquisition with one or more optical instruments (such as one or more optical probes, one or more catheters, one or more endoscopes, one or more capsules (e.g., one or more tethered capsules), one or more needles (e.g., biopsy needles), etc.). Discussed herein are one or more apparatus, systems, methods, and storage media for characterizing, inspecting, and / or diagnosing, and / or measuring targets, samples, or objects in applications employing devices or systems that use and / or control one or more imaging modalities. [Background technology]

[0002] Fiber optic catheters and endoscopes have been developed to access internal organs. For example, in cardiology, optical coherence tomography (OCT) was developed to obtain depth-resolved images of blood vessels using catheters. Catheters (which may include a sheath, coils, and optical probes) may be navigated into the coronary arteries.

[0003] Optical Coherence Tomography (OCT) is a technique for obtaining high-resolution cross-sectional images of tissues and materials, enabling real-time visualization. The goal of OCT is to measure the time delay of light using interference optics and methods, such as Fourier transform or Michelson interferometers. Light from a light source is split by a splitter (e.g., a beam splitter) and sent to a reference arm and a sample (or measurement) arm. The reference beam is reflected from a reference mirror (partially reflective or other reflective element) in the reference arm, and the sample beam is reflected or scattered from the sample in the sample arm. The two beams are combined (or recombined) at the splitter, producing interference fringes. The output of the interferometer is detected by one or more detectors, such as photodiodes or multi-array cameras, in one or more instruments, such as a spectrometer (e.g., a Fourier transform infrared spectrometer). Interference fringes are produced when the path length of the sample arm matches the path length of the reference arm within the coherence length of the light source. By evaluating the output beam, the spectrum of the input radiation can be derived as a function of frequency. The frequency of the interference fringes corresponds to the distance between the sample arm and the reference arm. The higher the frequency, the greater the difference in path length. Single-mode fiber can be used for OCT optical probes, while double-clad fiber can be used for fluorescence and / or spectroscopy.

[0004] Multimodality systems, such as optical probe-based optical coherence tomography (OCT), fluorescence, and / or spectroscopy systems, have been developed to simultaneously acquire multiple pieces of information. During vascular diagnostic and interventional procedures, such as percutaneous coronary intervention (PCI), optical coherence tomography (OCT) users can struggle to understand tomographic images in correlation with other modalities due to information overload, which can lead to confusion in image interpretation.

[0005] Furthermore, in situations where two different images or videos (e.g., intravascular and angiography images or videos) are displayed side-by-side or together on a display, a user (e.g., a technician, physician, clinician, etc.) may have the impression that the two images or videos are somehow related. For example, the side-by-side display may suggest that the two images or videos occurred simultaneously. However, based on the design of an imaging or information processing device or system (e.g., an OCT device or system), the two image or video sequences are obtained from two completely independent paths. In many cases, the two image or video sources have slightly different latencies with respect to the arrival of the image or video data into a software component, processor component, or memory or memory pool. Upon such arrival, a fixed timestamp is typically provided for each image or video frame by a device or system clock. This timestamp is not the exact time the data was acquired.

[0006] To achieve the goal of synchronously displaying images or videos obtained from two data sources, it is necessary to know the exact relative delay difference between the images or videos. One previously proposed method is to perform a coregistration process on the data available during pullback to calculate the delay (e.g., angio delay) for each angio frame. However, such a process can be computationally intensive and prone to error. Furthermore, such a process is dependent on each pullback, and accuracy can be adversely affected by vascular anatomy and configuration.

[0007] It would therefore be desirable to provide at least one imaging, information or optical device / apparatus, system, method and storage medium for using, controlling and / or enhancing one or more imaging modalities (angiography, tomography, OCT, etc.) and for determining the exact delay difference between two different or separately received images or videos. It would also be desirable to provide at least one imaging, information or optical device / apparatus, system, method and storage medium for displaying synchronized images or videos obtained from two or more independent sources in parallel or simultaneous views on a display. Summary of the Invention

[0008] Accordingly, it is a broad object of the present disclosure to provide imaging devices, systems, methods, and storage media for using and / or controlling multiple imaging modalities (e.g., OCT, intravascular imaging (IVI), IVUS, NIRF, NIRAF, snake robots, robots, etc.) that employ synchronization of images and / or videos with delay measurements. It is also a broad object of the present disclosure to provide devices, systems, methods, and storage media for OCT using interference optics such as interferometers (e.g., spectral-domain OCT (SD-OCT), swept-wavelength OCT (SS-OCT), multimodal OCT (MM-OCT), intravascular ultrasound (IVUS), near-infrared autofluorescence (NIRAF), near-infrared spectroscopy (NIRS), near-infrared fluorescence (NIRF), therapy using light, sound, or other radiation sources, etc.).

[0009] One or more embodiments provide at least one intuitive graphical user interface (GUI), method, apparatus, device, system, or storage medium to provide information such as the molecular structure of an object (e.g., a blood vessel) and the ability to perform image and / or video synchronization and / or determine delay or angio delay.

[0010] One or more embodiments of the present disclosure function to determine the precise relative delay difference between images or videos. Such relative delay between an angiographic image or video and another type of image or video (such as an intravascular image or video or an OCT image or video) is referred to herein as "angio delay" or "angio delay time." More generally, such delay difference is referred to herein as "delay" or "delay time."

[0011] One or more embodiments of any of the methods described herein (e.g., synchronization methods, methods for determining delay or angio-delay, detection methods, imaging or visualization methods, etc.) can be used in conjunction with any feature of the devices, systems, other methods, storage media, or other structures described herein.

[0012] One or more embodiments of the present disclosure may employ systems for one or more imaging modalities that employ a GUI for displaying images of one imaging modality on a display side-by-side (or together with) images of another imaging modality. For example, without limitation, one or more embodiments may relate to an OCT system or MM-OCT system having a GUI operable to display tomographic images or video frames together with (or alongside) angiographic images or video frames.

[0013] By employing one or more of the features or techniques of the present disclosure, one or more embodiments can accomplish one or more of the following: (i) defining delay (e.g., angio delay for an angio video or image) and related concepts and identifying the best way to calculate delay and manage multiple measurements (e.g., typically in software or processor service mode before pullback); (ii) calculating accurate delay measurements (e.g., accurate angio delay measurements) using a typical pullback process and linear regression with zoomed-in angiographic views (e.g., at least a first embodiment of the method of the present disclosure); (iii) using a rotating instrument with a geometric (e.g., triangular) window for angiography and an LED (e.g., (iv) storing and managing multiple delay measurements (e.g., angio delay) in a service mode table and applying the averaged result as the delay (e.g., angio delay) applied to pullbacks obtained in the same operating room (OR) environment; and / or (v) using a service mode that supports improved visualization elements in the GUI of one or more systems (e.g., an OCT system, an MM-OCT system, systems of one or more imaging modalities, etc.) for delay measurements (e.g., angio delay measurements) using one or more methods described herein.

[0014] Additionally or alternatively, one or more embodiments of the present disclosure may achieve at least the following advantages or may include at least the following features: (i) based on an analysis of a device / system (e.g., an OCT device / system, an MM-OCT device / system, a device / system of one or more imaging modalities, etc.) and its usage environment, delay measurements (e.g., angio delay measurements) may be independent of individual pullbacks or may be measured in advance (e.g., as part of a system configuration process, such as in service mode); (ii) a service mode may be designed to provide delay measurements (e.g., angio delay measurements) and maintain an operating room (OR)-dependent database to keep a record of all measurements; (iii) a service mode may define a systematic procedure for measuring delays (e.g., angio delays, imaging modality delays, etc.) and provide accurate measurements. A graphical user interface (GUI) may be provided to assist in the calculation or determination; (iv) one or more embodiments of the present disclosure may use a catheter (e.g., a simple catheter) with an angio (or other imaging / imaging modality) opaque marker in the test pullback as a method of measuring delay values ​​(e.g., angio delay values, imaging or imaging modality delay values, etc.) in one or more methods of the present disclosure, and may use linear regression methods to improve the accuracy of the resulting delay (e.g., angio delay, imaging / imaging modality delay, etc.) values; and / or (v) one or more embodiments of the present disclosure may use a synchronization signal for the measurement, so one or more embodiments of the present disclosure may use a rotating device and a catheter designed to support delay (e.g., angio delay) as a more accurate method or process.

[0015] In one or more embodiments, the object may be a blood vessel and the acquisition location may be a diseased area and / or an area that a physician, clinician, or other user of the device is considering for further assessment. In one or more embodiments, the object may be a sample or other target structure from which to image or gather information.

[0016] In one or more embodiments, the one or more processors may be further operable to perform one or more of the following: (i) displaying on the display images of each of a plurality of imaging modalities, the plurality of imaging modalities including a tomography image, an optical coherence tomography (OCT) image, a fluorescence image, a near-infrared fluorescence (NIRF) image, a near-infrared fluorescence (NIRF) image in a predetermined view (e.g., carpet view, indicator view, etc.), a near-infrared autofluorescence (NIRAF) image, a near-infrared autofluorescence (NIRAF) image in a predetermined view (e.g., carpet view, indicator view, etc.), a three-dimensional (3D) rendering, a 3D rendering of a blood vessel, a 3D rendering of a blood vessel in a semi-vascular view or representation, a 3D rendering of an object, a lumen profile, a lumen diameter representation, a longitudinal view, a computed tomography (CT), a magnetic resonance imaging (MRI), an intravascular ultrasound (IVUS), an X-ray image or view, and an angiography view; (ii) displaying on a display an image of each of a plurality of imaging modalities, the plurality of imaging modalities including three or more of a tomography image, an optical coherence tomography (OCT) image, a fluorescence image, a near-infrared fluorescence (NIRAF) image, a near-infrared fluorescence (NIRAF) image in a predetermined view (e.g., carpet view, indicator view, etc.), a three-dimensional (3D) rendering, a 3D rendering of a blood vessel, a 3D rendering of a blood vessel in a semi-vascular view or representation, a 3D rendering of an object, a lumen profile, a lumen diameter representation, a longitudinal view, a computed tomography (CT), a magnetic resonance imaging (MRI), an intravascular ultrasound (IVUS), an X-ray image or review, and an angiography view; and (iii) modifying or updating the display of each of the plurality of imaging modalities based on the in-plane orientation information and / or based on a request to update or change the in-plane orientation.

[0017] When a user acquires an intravascular image at a location within an object, that particular portion of the object may be in a predetermined location based on previous angiographic images or other information.

[0018] One or more embodiments of an imaging device or system used for synchronization and / or angio delay (or lag time) measurement may include any feature or combination of features described in this disclosure. For example, the one or more image processing devices or systems may include one or more processors operable to perform the following: acquiring one or more angiographic images of an object; acquiring one or more intravascular images at an acquisition location within at least a portion of the object, where the one or more angiographic images are acquired before, after, or simultaneously with the acquisition of the one or more intravascular images, where the one or more angiographic images are acquired from a first data source and the one or more intravascular images are acquired separately from a second data source; and determining one or more angio delay times or one or more lag times, which are the difference in latency between the first data source and the second data source, respectively. The one or more processors of the imaging device or system may perform any of the techniques described herein. For example, the one or more processors may be further operable to: (i) measure one or more angio delay times or one or more delay times using a controlled pullback; or (ii) measure one or more angio delay times or one or more delay times using a synchronization signal.

[0019] In one or more embodiments, the system or device may further include: a catheter or probe having one or more markers or radiopaque markers, the catheter or probe operable to acquire one or more angiographic images of the object and one or more intravascular images of the object. If a controlled pullback is used, the one or more processors may further be operable to: perform a controlled pullback and review data of the one or more angiographic images; label the locations of the one or more markers or radiopaque markers; apply a linear regression process to determine fractional starting times; and estimating or determining one or more angio delay times or one or more delay times and / or tolerances for the one or more angio delay times or one or more delay times based on the portion start times or the times when the one or more markers or radiopaque markers move or start to move, and accepting the estimated or determined one or more angio delay times or one or more delay times and / or tolerances if the estimated or determined one or more angio delay times or one or more delay times and / or tolerances are within respective predetermined or set thresholds and / or entering the estimated or determined one or more angio delay times or one or more delay times and / or tolerances into a results data table. The one or more processors may further be operable to estimate or determine one or more angio delay times or one or more delay times by calculating a difference between a portion start time, or a time when one or more markers or radiopaque markers move or begin to move, and a time when a first intravascular image of the one or more intravascular images was acquired during or near the controlled pullback.

[0020] In one or more embodiments, the system or device may further comprise a spin motor and a linear pullback motor, in which case (i) the one or more processors may be further operative to find each of the one or more estimated or determined angio delay times or one or more delay times as a time difference between a time when the spin motor is ready to record after starting and reaching a constant, predetermined, or target speed and a time when one or more angiographic images begin to be acquired, (ii) the one or more processors may be further operative to determine an occurrence time of the controlled pullback, an image capture start time of the controlled pullback, and a difference between the occurrence time and the image capture start time, wherein the difference between the occurrence time and the image capture start time represents the time it takes for the linear pullback motor to go from a default or rest state to a ready-to-pullback state, the ready-to-pullback state being a state in which the linear pullback motor initiates controlled pullback and captures one or more angiographic images and / or one or more intravascular images, and (iii) the one or more processors may be further operative to find each of the estimated or determined one or more angio delay times or one or more delay times as a time difference between a time when the spin motor is ready to record after starting and reaching a constant, predetermined, or target speed and a time when one or more angiographic images begin to be acquired, and (iv) the one or more processors may be further operative to calculate a total delay time by adding each of the delay times to the respective difference between the occurrence time of the controlled pullback and the start time of image capture; and / or the one or more processors may be further operative to interpolate the start time of the controlled pullback to a sub-angio interval level, the interpolation functioning to match a first intravascular image of the one or more intravascular images with a timestamp between two adjacent angio images; and (iv) the one or more processors may be further operative to determine a period during which the one or more angiographic images and / or one or more intravascular images are acquired during the pullback, the period starting at a first time that is an amount equal to one or more angio delay times or a delay time of the one or more delay times after the start time of the controlled pullback, and the period ending at a second time that is an amount equal to one or more angio delay times or a delay time of the one or more delay times after the end time of the pullback.In one or more embodiments, one or more of the following conditions may occur or exist: (i) the controlled pullback data includes one or more data packets, each of the one or more data packets including an intravascular image frame, and one or more of the data packets may include a video frame; (ii) the frame collection rate of the one or more intravascular images may be 200 frames per second (FPS), the controlled pullback length may be 80 mm, the controlled pullback period may be 2.0 seconds, and the average frame resolution of the horizontal pullback distance may be approximately 0.2 mm per frame; and / or (iii) the device may further include a clock and a video acquisition board or frame grabber, which may be operable to capture the video frames as digital frames and register the digital frames with one or more processors along with a timestamp from the clock, which may be operable to adjust, order, or rank the relative association, order, or display of the one or more angiographic images and / or the one or more intravascular images.

[0021] In one or more embodiments, the system or device may further include a catheter or probe operable to acquire one or more angiographic images of the object and one or more intravascular images of the object, and a rotating device having a stationary portion and a rotating portion, each of the stationary portion and the rotating portion having a window or region, the window or region of the rotating portion configured to overlap the window or region of the stationary portion at one or more times during a rotation of the rotating portion, and where the synchronization signal is used to measure one or more angio delay times or one or more delay times, the one or more processors may further be operable to: (i) prepare the device and the catheter or probe with near-infrared fluorescence (NIRF) light and / or near-infrared autofluorescence (NIRAF) light and / or rotate the rotating portion of the rotating device for pullback; (ii) initiate pullback, turn on the NIRF light and / or NIRAF light, and trigger rotation of the rotating portion of the rotating device to rotate one or more revolutions under an angio image view; (iii) perform a pullback on or around the angio frame. (iv) detecting frames in which the NIRF and / or NIRAF light is on by detecting NIRF and / or NIRAF light signals on or with one or more intravascular images and finding the center, middle, or other predetermined portion of the NIRF and / or NIRAF signal; and / or (v) determining a peak time at which the calculated open window or area is maximum by determining or identifying a corresponding time value for a corresponding portion or location of the NIRF and / or NIRAF light, and / or calculating one or more angio delay times or one or more delay times based on a signal represented by an overlap amount between at least an open window or area of ​​the rotating device and one or more open areas in one or more angio images, and calculating a time difference between the peak time and the corresponding time value determined or identified for a corresponding portion or location of the NIRF and / or NIRAF light.In one or more embodiments, one or more of the following conditions may occur or exist: (i) the rotating and stationary portions of the rotating device may each have plates of the same size and / or shape, each plate having a window or area of ​​the same size and / or shape, or the rotating and stationary portions of the rotating device each have plates of the same size and / or shape, each plate having a window or area of ​​the same size and / or shape, the shape being one of a triangle, a trapezoid, a square, a rectangle, a trapezoid, and a circle; (ii) the stationary portion may be fixed to a base or other location of the rotating device, and the rotating portion operates to rotate about an axis on or adjacent to the stationary portion, thereby (iii) the rotating device may evaluate and confirm whether the window or area is partially or completely overlapped using X-rays that pass through or are blocked by the window or area detectable in one or more angiographic images; and (iv) the rotating device may include a switch and a light-emitting diode (LED), the switch functions to connect both the rotating and stationary portions when the window or area is at a peak time such that the switch turns on the LED at peak times and turns off the LED at other times. In one or more embodiments, the one or more processors may be operable to: (i) display or present the overlapping windows or regions from a closed position or state of the shutter to the maximum area of ​​complete overlap of the windows or regions at the peak time; (ii) measure the size of the windows or regions in each image frame of one or more intravascular images and / or in each frame of one or more angiographic images; and (iii) interpolate the peak time using two adjacent frames to increase the accuracy of the location of the peak time if the peak time is between frames.

[0022] One or more embodiments of a method or process may include any feature or combination of features described herein. For example, a method for measuring or determining one or more angio delay times and / or performing angiographic synchronization using an imaging device having one or more processors may include: acquiring, by the one or more processors, one or more angiographic images of an object; acquiring, by the one or more processors, one or more intravascular images at acquisition locations within at least a portion of the object, where the one or more angiographic images are acquired before, after, or concurrently with the acquisition of the one or more intravascular images, where the one or more angiographic images are acquired from a first data source and the one or more intravascular images are acquired separately from a second data source; and determining, by the one or more processors, one or more angio delay times or one or more delay times, which are differences in latency between the first data source and the second data source, respectively. The method may further include: (i) one or more processors measuring one or more angio delay times or one or more delay times using a controlled pullback; or (ii) one or more processors measuring one or more angio delay times or one or more delay times using a synchronization signal.

[0023] In one or more method embodiments, if a controlled pullback is used and the imaging device further includes one or more markers or radiopaque markers and a catheter or probe, or is in communication with the one or more markers or radiopaque markers and the catheter or probe, and the catheter or probe is operable to acquire one or more angiographic images of the object and one or more intravascular images of the object and the one or more markers or radiopaque markers, the method may further include: performing a controlled pullback and reviewing data of the one or more angiographic images; labeling the locations of the one or more markers or radiopaque markers; and applying a linear regression process by the one or more processors to determine the portion start times or the one or more markers or radiopaque markers. and, the one or more processors estimating or determining one or more angio delay times or one or more delay times and / or tolerances for the one or more angio delay times or one or more delay times based on the portion start times or the times at which the one or more markers or radiopaque markers move or start to move, and accepting the estimated or determined one or more angio delay times or one or more delay times and / or tolerances if the estimated or determined one or more angio delay times or one or more delay times and / or tolerances are within respective predetermined or set thresholds, and / or entering the estimated or determined one or more angio delay times or one or more delay times and / or tolerances into a results data table. In one or more embodiments, the step of estimating or determining the one or more angio delay times or one or more delay times may further include calculating a portion start time or the difference between the time at which the one or more markers or radiopaque markers move or begin to move and the time at which a first intravascular image of the one or more intravascular images was acquired during or near the controlled pullback.In one or more embodiments, the method may further include: (i) the one or more processors finding the estimated or determined one or more angio delay times or each of the one or more delay times as the time difference between the time when a spin motor of the imaging device is ready to record after starting and reaching a constant, predetermined, or target speed and the time when one or more angiographic images begin to be acquired; (ii) the one or more processors determining an occurrence time of the controlled pullback, an image capture start time of the controlled pullback, and a difference between the occurrence time and the image capture start time, wherein the difference between the occurrence time and the image capture start time represents the time it takes a linear pullback motor of the imaging device to go from a default or rest state to a pullback ready state, the pullback ready state being a state in which the linear pullback motor starts the controlled pullback and captures one or more angiographic images and / or one or more intravascular images; (iii) the one or more processors finding the estimated or determined one or more angio delay times or each of the one or more delay times as the time difference between the occurrence time of the controlled pullback, an image capture start time of the controlled pullback, and a difference between the occurrence time and the image capture start time, wherein the difference between the occurrence time and the image capture start time represents the time it takes a linear pullback motor of the imaging device to go from a default or rest state to a pullback ready state, the pullback ready state being a state in which the linear pullback motor starts the controlled pullback and captures one or more angiographic images and / or one or more intravascular images; and (iv) the one or more processors determining a time period during which one or more angiographic images and / or one or more intravascular images are acquired during the pullback, the time period starting at a first time that is an amount equal to the angio delay time or the delay time of the one or more delay times after the start time of the controlled pullback and the amount equal to the angio delay time or the delay time of the one or more delay times after the end time of the pullback.In one or more embodiments, the method may further include: capturing controlled pullback data, the data including one or more data packets, each of the one or more data packets including an intravascular image frame, one or more of the data packets including a video frame captured in a digital frame; and registering the digital frames with a timestamp in one or more processors, the timestamp functioning to adjust, order, or rank the relative association, order, or display of the one or more angiographic images and / or one or more intravascular images. In one or more embodiments, the intravascular image frames of the one or more data packets may include optical coherence tomography (OCT) image frames, multimodal OCT (MM-OCT) images, near-infrared fluorescence (NIRF) image frames, near-infrared autofluorescence (NIRAF) image frames, other intravascular image frames, and / or a combination of OCT, MM-OCT, NIRF, NIRAF, and / or other intravascular image frames; the method may further include: (i) the one or more processors synchronizing the one or more MM-OCT images, OCT images, intravascular images, and / or other intravascular image frames to perform angiography image synchronization. (ii) acquiring, calculating, or determining a relative delay time between the time of the image or other imaging modality image and one or more angio delay times or angio delay times or delay times of one or more delay times; (ii) setting a target time for synchronizing each of the one or more intravascular images and each of the one or more angiographic images as a time at a midpoint or other predetermined position of each image acquisition; and / or (iii) evaluating a sample rate of the one or more intravascular images and a sample rate of the one or more angiographic images to determine the accuracy of the image, delay, or synchronization results.

[0024] In one or more method embodiments, when the synchronization signal is used and the imaging device further includes a catheter or probe operable to acquire one or more angiographic images of the object and one or more intravascular images of the object, and a rotating instrument having a stationary portion and a rotating portion, or is in communication with the catheter or probe and the rotating instrument, the stationary portion and the rotating portion each having a window or area, and the window or area of ​​the rotating portion configured to overlap with the window or area of ​​the stationary portion at one or more times during rotation of the rotating portion, the method may further include the steps of: (i) preparing the imaging device and the catheter or probe with near-infrared fluorescence (NIRF) light and / or near-infrared autofluorescence (NIRAF) light, and / or preparing to rotate the rotating portion of the rotating instrument for pullback; (ii) initiating pullback, turning on the NIRF light and / or NIRAF light, and triggering rotation of the rotating portion of the rotating instrument to rotate one or more times under the angio image view; (iii) one or more processors, on or using the angio frame, (iv) detecting frames in which the NIRF and / or NIRAF light is on by one or more processors detecting signals of the NIRF and / or NIRAF light on or with one or more intravascular images and finding the center, middle or other predetermined portion of the NIRF and / or NIRAF signal; and / or (v) calculating one or more angio delay times or one or more delay times based on signals represented by the amount of overlap between at least the open window or region of the rotating device and one or more open regions in the one or more angio images, and calculating the time difference between the peak time and the corresponding time value determined or identified for the corresponding portion or position of the NIRF and / or NIRAF light.In one or more embodiments, the stationary portion may be fixed to a base or other location of the rotating device, and the rotating portion may be operable to rotate about an axis on the stationary portion or an axis adjacent to the stationary portion, whereby the rotating portion acts as a shutter, the shutter being open when the windows or regions of the rotating and stationary portions partially or completely overlap, and closed otherwise, and the method may further include: (i) displaying or presenting the overlapping windows or regions from a closed position or state of the shutter to a maximum area of ​​complete overlap of the windows or regions at the peak time; (ii) measuring the size of the windows or regions in each image frame of the one or more intravascular images and / or in each frame of the one or more angiographic images; and (iii) interpolating the peak time using two adjacent frames to increase the accuracy of the location of the peak time if the peak time is between frames.

[0025] In one or more embodiments of the devices, systems, methods, or storage media described herein, one or more of the following conditions may occur or exist: (i) the intravascular image frames of the one or more data packets may include optical coherence tomography (OCT) image frames, multimodal OCT (MM-OCT) images, near-infrared fluorescence (NIRF) image frames, near-infrared autofluorescence (NIRAF) image frames, other intravascular image frames, and / or a combination of OCT, MM-OCT, NIRF, NIRAF, and / or other intravascular image frames; (ii) the one or more processors may synchronize one or more MM-OCT images, OCT images, vascular images, and / or other intravascular image frames to perform angiography image synchronization. (iii) the one or more processors may be further operable to set a target time for synchronizing each of the one or more intravascular images with each of the one or more angiographic images as a time at an intermediate position or other predetermined position of each image acquisition; and / or (iv) the one or more processors may be further operable to evaluate a sample rate of the one or more intravascular images and a sample rate of the one or more angiographic images to determine the accuracy of the image, delay, or synchronization results.

[0026] In one or more embodiments of the devices, systems, methods, or storage media described herein, the techniques and / or one or more processors may function as follows: (i) displaying a graphical user interface (GUI) on a display, the GUI functioning to manage and display angio delay time information for multiple operating rooms (ORs) or other locations so that the device is configured for use in different locations; (ii) performing an initialization process functioning to add or include data for all of the ORs or other locations in the device; and (iii) performing one or more angio delay time or delay time estimations or determinations for each of all of the ORs and other locations that have data added or included in the device to enable angio delay compensation to be applied to all pullbacks made at each of all of the ORs and other locations.In one or more embodiments, the technique and / or one or more processors may perform one or more of the following: co-register one or more acquired angiographic images with one or more intravascular images; co-register one or more acquired angiographic images with one or more intravascular images, where the one or more intravascular images are one or more optical coherence tomography (OCT) images or frames or intravascular ultrasound (IVUS) images or frames, tomographic images, fluorescence images, near-infrared fluorescence (NIRAF) images, near-infrared fluorescence (NIRAF) images in a predetermined view, carpet view, and / or indicator view, three-dimensional (3D) rendering, 3D rendering of a vessel, 3D rendering of a vessel in a semi-vascular view or representation, 3D rendering of an object, lumen profile, lumen diameter representation, longitudinal view, computed tomography (CT), magnetic resonance imaging (MRI), or other imaging techniques. and / or displaying on a display an image of each of a plurality of imaging modalities, the plurality of imaging modalities including two or more of: a tomographic image, an optical coherence tomography (OCT) image, a fluorescence image, a near-infrared fluorescence (NIRAF) image, a near-infrared fluorescence (NIRAF) image in a predetermined view, a carpet view, and / or an indicator view, a three-dimensional (3D) rendering, a 3D rendering of a blood vessel, a 3D rendering of a blood vessel in a semi-vascular view or representation, a 3D rendering of an object, a lumen profile, a lumen diameter representation, a longitudinal view, a computed tomography (CT), a magnetic resonance imaging (MRI), an intravascular ultrasound (IVUS), an X-ray image or view, and an angiography view.

[0027] One or more embodiments of the storage medium may include any feature or combination of features described herein. For example, a non-transitory computer-readable storage medium may store at least one program for causing a computer to execute a method for measuring or determining one or more angio delay times and / or performing angiographic synchronization using an imaging device having one or more processors, the method may include: acquiring, by the one or more processors, one or more angiographic images of an object; acquiring, by the one or more processors, one or more intravascular images at acquisition locations within at least a portion of the object, the one or more angiographic images being acquired before, after, or concurrently with the acquisition of the one or more intravascular images, where the one or more angiographic images are acquired from a first data source and the one or more intravascular images are acquired separately from a second data source; and determining, by the one or more processors, one or more angio delay times or one or more delay times, which are differences in latency between the first data source and the second data source, respectively. The storage medium may include, implement, or be used in conjunction with other technologies or structures described herein.

[0028] In the following paragraphs, certain illustrative embodiments are described. Other embodiments may include alternatives, equivalents, and modifications. In addition, the illustrative embodiments may include some novel features, and certain features may not be essential to all embodiments of the devices, systems, and methods described herein. Furthermore, although certain embodiments are described herein, embodiments of the present disclosure are not limited thereto, and any combination of features described herein may be used in any combination in one or more embodiments of the present disclosure.

[0029] According to other aspects of the present disclosure, one or more additional devices, one or more systems, one or more methods, and one or more storage media for constructing / reconstructing 3D structures using OCT and / or other imaging modality techniques are discussed herein. Further features of the present disclosure will be in part apparent and in part understood from the following description and with reference to the accompanying drawings. [Brief explanation of the drawings]

[0030] For the purpose of illustrating various aspects of the present disclosure, where like numerals refer to like elements, the drawings show simplified forms that may be employed. It should be understood, however, that the disclosure is not limited to or by the precise arrangements and instrumentalities shown. To assist those skilled in the art in making and using the subject matter herein, reference is made to the accompanying drawings and figures.

[0031] [Figure 1A] FIG. 1A is a schematic diagram illustrating at least one embodiment of a system that can be used to view and control one or more imaging modalities and / or perform angio delay determination and / or synchronization techniques in accordance with one or more aspects of the present disclosure. [Figure 1B] FIG. 1B is a schematic diagram illustrating an imaging system for performing one or more steps for processing image data and / or performing angio delay determination and / or synchronization techniques in accordance with one or more aspects of the present disclosure. [Figure 2] FIG. 2 is an illustration of at least one embodiment of a catheter that can be used in conjunction with one or more embodiments for performing image and / or video synchronization and / or delay determination in accordance with one or more aspects of the present disclosure. [Figure 3] FIG. 3 illustrates at least one embodiment of a graphical user interface (GUI) for displaying intravascular images or videos along with angiographic images or videos that can be used in accordance with one or more aspects of the present disclosure. [Figure 4A]FIG. 4A is a diagram of at least one embodiment of a timeline that can be used to define delay times for two or more independent paths or sources of images or video, in accordance with one or more aspects of the present disclosure. [Figure 4B] FIG. 4B illustrates at least one embodiment of an image frame mapping pattern that may occur between an intravascular OCT / NIRF / NIRAF image and an angiography image or video frame due to differences in sampling frequency, in accordance with one or more aspects of the present disclosure. [Figure 5] 5A-5B illustrate at least one embodiment of a device or system and its pullback that may be used in accordance with one or more aspects of the present disclosure. [Figure 6] FIG. 6 is a flowchart of at least one method that can be used to measure or determine delay time or angio-delay time, according to one or more aspects of the present disclosure. [Figure 7] 7A and 7B are at least one embodiment of a top view and a side view of a rotational device or system operable to measure delay or angio-delay, respectively, according to one or more aspects of the present disclosure. [Figure 8] 8A illustrates at least one embodiment of an angiographic image used for assessing synchronization and / or delay time, according to one or more aspects of the present disclosure. FIG. 8B illustrates at least one embodiment of a light emitting diode (LED)-based catheter or probe and environment of use, according to one or more aspects of the present disclosure. [Figure 9] FIG. 9 illustrates at least one embodiment of results that may be obtained upon use of a method, apparatus, system, or storage medium for measuring delay or angio-delay, according to one or more aspects of the present disclosure. [Figure 10] FIG. 10 is a flowchart of at least one further method that can be used to measure or determine delay times or angio-delay times, according to one or more aspects of the present disclosure. [Figure 11]FIG. 11 illustrates at least one embodiment of a GUI showing at least one example of a group of delay or angio-delay measurements according to one or more aspects of the present disclosure. [Figure 12A] FIG. 12A illustrates at least one embodiment of an OCT device or system for performing image and / or video synchronization and / or utilizing one or more imaging modalities for measuring or determining delay or angio-delay, according to one or more aspects of the present disclosure. [Figure 12B] FIG. 12B illustrates at least another embodiment of an OCT device or system for performing image and / or video synchronization and / or utilizing one or more imaging modalities for measuring or determining delay or angio-delay, according to one or more aspects of the present disclosure. [Figure 12C] FIG. 12C illustrates at least a further embodiment of an OCT and NIRF / NIRAF device or system for performing image and / or video synchronization and / or utilizing one or more imaging modalities for measuring or determining delay or angio-delay, according to one or more aspects of the present disclosure. [Figure 13] FIG. 13 is a flowchart illustrating a method for performing imaging features, functions, or techniques according to one or more aspects of the present disclosure. [Figure 14] FIG. 14 shows a schematic diagram of an embodiment of a computer that can be used in conjunction with one or more embodiments of the apparatus or system or one or more methods described herein, in accordance with one or more aspects of the present disclosure. [Figure 15] FIG. 15 shows a schematic diagram of another embodiment of a computer that can be used with one or more embodiments of the imaging device or system or method described herein, in accordance with one or more aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0032] While the following description is of certain exemplary embodiments, other embodiments may include alternatives, equivalents, and modifications. In addition, exemplary embodiments may include certain novel features, and certain features may or may not be used in the implementation of one or more embodiments of the devices, systems, and methods described herein. The embodiments are described below with reference to the accompanying drawings. Like numbers refer to like elements throughout. It should be noted that the following description is merely illustrative and exemplary in nature and is not intended to limit the disclosure and its application or uses. The relative arrangement of components and steps, numerical expressions, and values ​​described in the embodiments do not limit the scope of the disclosure unless specifically stated otherwise. Techniques, methods, and devices well known to those skilled in the art may not be described in detail, as those skilled in the art need not know those details to be able to use the embodiments described below. Furthermore, the endoscopes and other imaging devices described herein are not limited to the described applications or uses. One or more non-limiting, non-exhaustive examples of endoscopes or specialized endoscopes include, for example, angioscopes, anusoscopes, arthroscopes, arteroscopes, arthroscopes, bronchoscopes, capsule endoscopes, cholangioscopes, colonoscopes, colposcopes, cystoscopes, encephaloscopes, esophagogastroduodenoscopes, esophagoscopes, gastroscopes, hysteroscopes, laparoscopes, laryngoscopes, mediastinoscopes, nephroscopes, neuroendoscopes, rectoscopes, resectoscopes, nasoscopes, sigmoidoscopes, sinusoscopes, thoracoscopes, ureteroscopes, hysteroscopes, borescopes, fiberscopes, examination cameras, and / or any specialized endoscope or imaging device that can be configured to include one or more features of the present disclosure. In one or more embodiments, the endoscope can be flexible or rigid. Also, one or more embodiments can be a probe or imaging device, such as other imaging devices or systems described herein.

[0033] A broad object of the present disclosure is to provide imaging devices, systems, methods, and storage media for using and / or controlling multiple imaging modalities (e.g., OCT, IVI, IVUS, NIRF, NIRAF, snake-like robots, robotics, and other imaging modalities known to those skilled in the art) that employ synchronization of images and / or videos with delay measurements. It is also a broad object of the present disclosure to provide OCT devices, systems, methods, and storage media that use interference optics such as interferometers (e.g., spectral-domain OCT (SD-OCT), swept-wavelength OCT (SS-OCT), multimodal OCT (MM-OCT), intravascular ultrasound (IVUS), near-infrared autofluorescence (NIRAF), near-infrared spectroscopy (NIRS), near-infrared fluorescence (NIRF), and therapies using light, sound, or other radiation sources).

[0034] One or more embodiments provide at least one intuitive graphical user interface (GUI), method, apparatus, device, system, or storage medium to provide information such as the molecular structure of an object (e.g., a blood vessel) and the ability to perform image and / or video synchronization and / or determine delay or angio delay.

[0035] One or more embodiments of the present disclosure function to account for accurate relative delay differences between images or videos. Such relative delays between angiographic images or videos and other types of images or videos are referred to herein as "angio delays" or "angio delay times." More generally, such delay differences are referred to herein as "delays" or "delay times." Indeed, in one or more embodiments, other imaging modalities may be used such that the delays are relative to images or videos of imaging / video modalities other than angiographic images or videos.

[0036] One or more embodiments of any of the methods described herein (e.g., synchronization methods, methods for determining delay or angio-delay, detection methods, imaging or visualization methods, etc.) can be used in conjunction with any feature of the devices, systems, other methods, storage media, or other structures described herein.

[0037] One or more embodiments of the present disclosure may employ systems for one or more imaging modalities that employ a GUI for displaying images of one imaging modality on a display side-by-side (or together with) images of another imaging modality. For example, without limitation, one or more embodiments may relate to an OCT system or MM-OCT system having a GUI operable to display tomographic images or video frames together with (or alongside) angiographic images or video frames.

[0038] By employing one or more of the features or techniques of the present disclosure, one or more embodiments can accomplish one or more of the following: (i) defining delay (e.g., angio delay for an angio video or image) and related concepts and identifying the best way to calculate delay and manage multiple measurements (e.g., typically in software or processor service mode before pullback); (ii) calculating accurate delay measurements (e.g., accurate angio delay measurements) using a typical pullback process and linear regression with zoomed-in angiographic views (e.g., at least a first embodiment of the method of the present disclosure); (iii) using a rotating instrument with a geometric (e.g., triangular) window for angiography and an LED (e.g., (iv) storing and managing multiple delay measurements (e.g., angio delay) in a service mode table and applying the averaged result as the delay (e.g., angio delay) applied to pullbacks obtained in the same operating room (OR) environment; and / or (v) using a service mode that supports improved visualization elements in the GUI of one or more systems (e.g., an OCT system, an MM-OCT system, systems of one or more imaging modalities, etc.) for delay measurements (e.g., angio delay measurements) using one or more methods described herein.

[0039] Additionally or alternatively, one or more embodiments of the present disclosure may achieve at least the following advantages or may include at least the following features: (i) based on an analysis of a device / system (e.g., an OCT device / system, an MM-OCT device / system, a device / system of one or more imaging modalities, etc.) and its usage environment, delay measurements (e.g., angio delay measurements) may be independent of individual pullbacks or may be measured in advance (e.g., as part of a system configuration process, such as in service mode); (ii) a service mode may be designed to provide delay measurements (e.g., angio delay measurements) and maintain an operating room (OR)-dependent database to keep a record of all measurements; (iii) a service mode may define a systematic procedure for measuring delays (e.g., angio delays, imaging modality delays, etc.) and provide accurate measurements. A graphical user interface (GUI) may be provided to assist in the calculation or determination; (iv) one or more embodiments of the present disclosure may use a catheter (e.g., a simple catheter) with an angio (or other imaging / imaging modality) opaque marker in the test pullback as a method of measuring delay values ​​(e.g., angio delay values, imaging or imaging modality delay values, etc.) in one or more methods of the present disclosure, and may use linear regression methods to improve the accuracy of the resulting delay (e.g., angio delay, imaging / imaging modality delay, etc.) values; and / or (v) one or more embodiments of the present disclosure may use a synchronization signal for the measurement, so one or more embodiments of the present disclosure may use a rotating device and a catheter designed to support delay (e.g., angio delay) as a more accurate method or process.

[0040] In one or more embodiments of an imaging or medical device / system having one or more processors that function to assess or determine delay (e.g., angio delay), the one or more processors may further function as follows: (i) acquiring or receiving image data during a pullback movement of the intravascular imaging catheter.

[0041] In one or more embodiments, the object or sample may include one or more of a blood vessel, a target specimen or object, and a patient.

[0042] Disclosed herein are one or more devices / apparatus, optical systems, methods, and storage media for performing one or more synchronization and / or delay measurement techniques and / or one or more imaging techniques. At least Figures 1-15 and the following disclosure contained herein provide a schematic and visual depiction of several embodiments of the present disclosure, which may be implemented by one or more embodiments of the disclosed devices, systems, methods, and / or computer-readable storage media.

[0043] Turning now to the details of the figures, imaging modalities can be displayed in one or more ways as described herein. One or more of the displays described herein can enable a user of one or more of the displays to use, control, and / or enhance one or more imaging techniques or modalities, such as angiography, OCT, NIRF, NIRAF, etc., and can also enable a user to use, control, and / or enhance one or more imaging techniques or modalities simultaneously.

[0044] In at least one further embodiment, image and / or video synchronization and / or delay measurement methods may be employed. One or more methods of the present disclosure may use, but are not limited to, an intravascular imaging or video frame (e.g., IVUS, OCT, MM-OCT, etc.) and an angiographic view (e.g., an imaging or video frame). For example, one or more embodiments of the present disclosure synchronize an intravascular image / video with an angiographic image / video on a display or screen (e.g., an OCT display or screen, an MM-OCT display or screen, a display or screen of another imaging modality, etc.) during pullback at review or display time. In one or more embodiments, an intravascular image may be referred to as a tomo image, an MM-OCT image, or an OCT image. In one or more embodiments using a tomo image, a cross-sectional tomographic view of a target or object (e.g., a blood vessel) may include NIRF and / or NIRAF signals (if available). In one or more embodiments, an angiographic image or video frame may be used synonymously with the term "angio image or video frame." In one or more other embodiments, any other imaging / imaging modality or any combination of imaging / imaging modalities may be used in one or more methods of the present disclosure. Although the intravascular imaging of the present disclosure is not limited to OCT, the following description uses OCT as a representative of intravascular imaging to describe one or more features herein.

[0045] In one or more embodiments of the present disclosure, one or more synchronization techniques and / or one or more delay determination techniques may be used in conjunction with OCT or other imaging modality equipment, systems, storage media, etc.

[0046] One or more devices / systems of the present disclosure may include one or more processors operable to perform one or more synchronization techniques and / or one or more delay determination techniques, or any other techniques described herein.

[0047] The one or more processors may be further operable to perform coregistration by coregistrating the acquired or received angiography image with one or more acquired optical coherence tomography (OCT) or intravascular ultrasound (IVUS) images or frames. In one or more embodiments, the processor may be operable to perform coregistration by coregistrating the acquired or received angiography image or video (or image / video of another imaging modality) with one or more acquired image or video frames of another imaging modality.

[0048] In one or more embodiments, the one or more processors may be further operable to perform one or more of the following: (i) displaying the angiography data on a display together with images of each of one or more imaging modalities, the one or more imaging modalities including tomography images, optical coherence tomography (OCT) images, fluorescence images, near-infrared autofluorescence (NIRAF) images, near-infrared autofluorescence (NIRAF) images at predetermined views, carpet views, and / or indicator views, near-infrared fluorescence (NIRF) images, near-infrared fluorescence (NIRF) images at predetermined views, carpet views, and / or indicator views, and three-dimensional (3D) images; (ii) displaying, including one or more of: renderings, 3D renderings of the blood vessel, 3D renderings of the blood vessel in semi-vascular views or displays, 3D renderings of the object, lumen profiles, lumen diameter displays, longitudinal views, computed tomography (CT), magnetic resonance imaging (MRI), intravascular ultrasound (IVUS), X-ray images or views, and angiography views; and (ii) modifying or updating the display of angiography data with each of one or more imaging modalities based on the results of the rotary joint health and / or device / system health and / or the updated position of the catheter (or other imaging equipment).In one or more embodiments, the one or more imaging modalities may include one or more of the following: optical coherence tomography (OCT); another luminal imaging modality; an intravascular imaging modality; an imaging modality for fluorescence; a near-infrared autofluorescence (NIRAF) imaging modality; a near-infrared autofluorescence (NIRAF) imaging modality in a predetermined view, carpet view, and / or indicator view; a near-infrared fluorescence (NIRF) imaging modality; a near-infrared fluorescence (NIRF) imaging modality in a predetermined view, carpet view, and / or indicator view; Three-dimensional (3D) rendering imaging modalities; imaging modalities for 3D rendering of blood vessels; imaging modalities for 3D rendering of blood vessels in semi-vascular views or views; imaging modalities for 3D rendering of objects, targets or specimens; imaging modalities for luminal profile; imaging modalities for luminal diameter views; imaging modalities for longitudinal views; computed tomography (CT); magnetic resonance imaging (MRI); intravascular ultrasound (IVUS); imaging modalities for X-ray images or views; and imaging modalities for angiographic views.

[0049] Just as an OCT (or other imaging modality) device or system can benefit from performing image / video synchronization and / or delay measurement / calculation, a snake-like device or system (or other type of robotic device or system), which may use the same or similar connections, can also benefit from accurately performing image / video synchronization and / or delay measurement / calculation. OCT (or other imaging modality or modality) applications may have mechanisms for data storage, and snake-like or robotic applications may also use data storage mechanisms in one or more embodiments. Furthermore, because snake-like or other robotic cameras may be or include color cameras and OCT images collected by OCT applications may be or include grayscale images, in one or more embodiments, a color-to-grayscale shift may also be employed for imaging applications, taking into account imaging quality and associated data.

[0050] As illustrated in FIG. 1A , one or more embodiments of the present disclosure for visualizing, enhancing, and / or controlling one or more imaging modalities for performing image / video synchronization, performing delay (e.g., angio delay) measurements, and / or performing coregistration may be involved in one or more predetermined or desired procedures (e.g., planning or performing a medical procedure, such as a percutaneous coronary intervention (PCI) or other vascular diagnostic or interventional procedure). For example, system 2 may communicate with an image scanner 5 (e.g., a CT scanner, an X-ray machine, etc.) to request information (e.g., bed positioning) for use in planning and / or performing a medical procedure (e.g., PCI), and as a clinician uses image scanner 5 to obtain information via a patient scan, image scanner 5 may transmit the requested information along with the images to system 2. In some embodiments, one or more angiograms 3 acquired simultaneously or from a previous session are provided for further planning and visualization. System 2 may also communicate with a workstation, such as a picture archiving and communication system (PACS) 4, to send and receive patient images to facilitate and assist in the planning and / or performance of the medical procedure. Once a plan is created, a clinician can use system 2 in conjunction with medical procedure / imaging equipment 1 (e.g., imaging equipment, OCT equipment, IVUS equipment, PCI equipment, ablation equipment, image / video synchronization and / or delay measurement equipment, etc.) to review the medical procedure chart or plan to understand the shape and / or size of the target biological object to be imaged and / or manipulated. Each of medical procedure / imaging equipment 1, system 2, locator equipment 3, PACS 4, and scanning equipment 5 can communicate in any manner known to those skilled in the art, including directly (via a communications network) or indirectly (through one or more of the other equipment, such as 1 or 5, or additional flush and / or contrast delivery equipment; through one or more of PACS 4 and system 2; through clinician interaction, etc.).

[0051] In medical procedures, it is desirable to improve or optimize physiological assessments to determine a particular patient's course of treatment. As at least one example, physiological assessments are highly useful in determining treatment for patients with cardiovascular disease. In a catheterization lab, for example, physiological assessments can be used as a decision-making tool to determine, for example, whether a patient should undergo a PCI procedure and whether the PCI procedure was successful. While the concept of using physiological assessments is sound, further adaptations and improvements to physiological testing remain desirable for clinical use. This situation may arise because of the increased need for separate equipment and medications for physiological assessments and / or the potential for physician-to-physician variability in measurement results due to technical issues. Such approaches increase complexity and lack of consistency. Accordingly, one or more embodiments of the present disclosure may employ computational fluid dynamics-based (CFD-based) physiological assessments that can be performed from imaging data to eliminate or minimize technical issues, complexities, and inconsistencies during measurement procedures. To obtain accurate physiological assessment, the exact 3D structure of blood vessels can be reconstructed from imaging data, as disclosed in U.S. Provisional Patent Application No. 62 / 901,472 (filed September 17, 2019, the disclosure of which is incorporated herein by reference in its entirety).

[0052] One or more embodiments of the present disclosure can achieve efficient image / video synchronization, efficient delay (e.g., angio delay) measurement, and / or efficient coregistration results from image and / or video frames. In one or more embodiments, image and / or video data can be acquired during intravascular imaging pullback using a catheter (or other imaging device) that can be visualized in the image or video frames.

[0053] 1B , a schematic diagram of at least one embodiment of an imaging system 20 for generating an imaging catheter path based on a detected position of the imaging catheter (e.g., based on a regression line representing the imaging catheter path) by using image / video frames acquired (e.g., simultaneously, separately, etc.) during intravascular imaging pullback. The embodiment of FIG. 1B can be used in conjunction with one or more of the synchronization and / or delay measurement features described herein. Without limitation, the imaging system 20 may include an angiography system 30, an intravascular imaging system 40, an image processor 50, a display or monitor 1209, and an electrocardiography (ECG) device 60 (or any combination or subcombination of these features). The angiography system 30 may include an X-ray imaging device (e.g., a C-arm 22) connected to an angiography system controller 24 and an angiography image processor 26 to acquire angiography image frames of an object (e.g., any object, sample, vessel, target specimen, or object, etc., that can be imaged using the size and shape of the imaging device) or a patient 106. In one or more embodiments, the features of the angiography system control 24 and the angiography image processor 26 may be performed by a single processor.

[0054] Without limitation, the intravascular imaging system 40 of the imaging system 20 may include a console 32, a catheter 120, and a patient interface unit or PIU 110 connecting between the catheter 120 and the console 32 to acquire intravascular image / video frames. The catheter 120 may be inserted into a blood vessel of the patient 106 (or inside a specimen or other target object). The catheter 120 may function as an optical illuminator and data collection probe positioned in the lumen of a particular blood vessel, such as a coronary artery. The catheter 120 may include a probe tip, one or more markers or radiopaque markers, an optical fiber, and a torque wire. The probe tip may include one or more data acquisition systems. The catheter 120 may be threaded into an artery of the patient 106 to acquire images and / or video frames of the coronary artery. The patient interface unit 110 may include a motor M therein to enable pullback of the imaging / video optics during acquisition of intravascular images and / or video frames. An imaging pullback procedure may be performed to acquire images and / or video frames of the blood vessel. The imaging pullback path can represent a co-registration path, which can be a region of interest or target region of a vessel (or another target or object).

[0055] The console 32 may include a light source 101 and a computer 1200. The computer 1200 may include features as described herein (see, e.g., FIGS. 1B, 12A-12C, 14, etc.), or may be a computer 1200′ (see, e.g., FIG. 15, etc.) or any other computer or processor described herein. In one or more embodiments, the computer 1200 may include an intravascular system controller 35 and an intravascular image processor 36 (or a single processor that functions to perform the features of the intravascular system controller 35 and the intravascular image processor 36). The intravascular system controller 35 and / or the intravascular image processor 36 may function to control the motor M in the patient interface unit 110. The intravascular image processor 36 may also perform various steps for image processing and control the information that is displayed.

[0056] Various types of intravascular imaging systems may be used within imaging system 20. Intravascular imaging system 40 is merely one example of an intravascular imaging system that may be used within imaging system 20. Various types of intravascular imaging systems may be used, including, by way of non-limiting and non-exhaustive example, OCT systems, multi-modality OCT systems, IVUS systems, etc. One or more imaging modalities may be used (e.g., angiography, optical coherence tomography (OCT), multi-modality OCT (MM-OCT), near-infrared autofluorescence (NIRAF), near-infrared fluorescence (NIRF), OCT-NIRAF, OCT-NIRF, etc.). One or more embodiments of the synchronization and / or delay measurement techniques and / or one or more imaging techniques described herein may be used in conjunction with optical probe applications, according to one or more aspects of the present disclosure.

[0057] Imaging system 20 may also be connected to electrocardiography (ECG) equipment 60 to record the electrical activity of the heart over a period of time using electrodes placed on the skin of patient 106. Imaging system 20 may also include an image processor 40 to receive angiography data, intravascular imaging data, and data from ECG device 60, perform various image processing steps, and send angiography images / video frames to display 1209 for display along with the coregistration path. Although image processor 50 associated with imaging system 20 appears to be external to both angiography system 30 and intravascular imaging system 40 in FIG. 1B , image processor 50 may be included within angiography system 30, intravascular imaging system 40, display 1209, or a standalone device. Alternatively, image processor 50 may not be required if the various image processing steps are performed using one or more of angiography image processor 26, intravascular image processor 36 of imaging system 20, or other processors described herein (e.g., computer 1200, computer 1200′, computer or processor 2, etc.).

[0058] FIG. 2 illustrates at least one embodiment of a catheter 120 that may be used in one or more embodiments of the present disclosure to acquire images, perform synchronization, and / or determine, measure, or calculate delay (or angio delay). FIG. 2 illustrates an embodiment of a catheter 120 that includes a sheath 121, a coil 122, a protector 123, and an optical probe 124. As shown schematically in FIGS. 12A-12C (described below), the catheter 120 may be connected to a patient interface unit (PIU) 110 to spin the coil 122 via pullback (e.g., at least one embodiment of the PIU 110 functions to spin the coil 122 via pullback). The coil 122 delivers torque from its proximal end to its distal end (e.g., via or by a rotary motor of the PIU 110). In one or more embodiments, the coil 122 is fixed with / to the optical probe 124 so that the distal end of the optical probe 124 also spins to obtain an omnidirectional view of an object (e.g., a biological organ, a sample or material under evaluation, such as a hollow organ such as a vessel, heart, coronary artery, etc.). For example, fiber optic catheters and endoscopes may reside within the sample arm of an OCT interferometer (such as the sample arm 103 shown in one or more of Figures 12A-12C below) to provide access to difficult-to-access internal organs (e.g., intravascular imaging, the gastrointestinal tract, or other confined areas). As a beam of light passing through the optical probe 124 inside the catheter 120 or endoscope rotates across a surface of interest, cross-sectional images of one or more objects are obtained. To acquire three-dimensional data, the optical probe 124 is simultaneously translated longitudinally while being rotationally spun, resulting in a helical scan pattern. This translation is most commonly performed by pulling the tip of the probe 124 back toward the proximal end, hence the term pullback.

[0059] The catheter 120 (which, as described above (and shown in FIG. 2 ), in one or more embodiments includes a sheath 121, a coil 122, a protector 123, and an optical probe 124) may be connected to the PIU 110. In one or more embodiments, the optical probe 124 may include a fiber optic connector, an optical fiber, and a distal lens. The fiber optic connector may be used to engage with the PIU 110. The optical fiber may function to deliver light to the distal lens. The distal lens may function to shape the light beam, illuminate the light onto an object (e.g., an object 106 described herein (e.g., a blood vessel)), and efficiently collect light from the sample (e.g., an object 106 described herein (e.g., a blood vessel)).

[0060] As mentioned above, in one or more embodiments, the coil 122 delivers torque from its proximal end to its distal end (e.g., via or by a rotary motor in the PIU 110). There may be a mirror at the distal end so that the light beam is deflected outward. In one or more embodiments, the coil 122 is fixed with / to the optical probe 124 so that the distal end of the optical probe 124 also spins to see an omnidirectional view of the object (e.g., a living organ, a sample or substance under evaluation, etc. (e.g., a hollow organ such as a blood vessel, heart, coronary artery, etc.)). In one or more embodiments, the optical probe 124 may include a fiber connector at its proximal end and a double-clad fiber and lens at its distal end. The fiber connector functions to interface with the PIU 110. The double-clad fiber can function to transmit and collect OCT light through the core and, in one or more embodiments, collect Raman and / or fluorescence light from an object (e.g., an object 106 (e.g., a blood vessel) described herein, an object and / or a patient (e.g., a blood vessel within a patient), etc.) through the cladding. A lens can be used to focus light onto and / or collect light from an object (e.g., an object 106 (e.g., a blood vessel) described herein). In one or more embodiments, because the size of the core is much smaller than the size of the cladding, scattered light through the cladding is relatively higher than scattered light through the core.

[0061] 3 illustrates at least one embodiment of a graphical user interface (GUI) for displaying an intravascular image or video 302 along with an angiographic image or video 301 that can be used in accordance with one or more aspects of the present disclosure. For example, a user can review pullbacks in a mode such as a review mode.

[0062] Figure 3 shows two images, side-by-side: an angiography frame 301 and an intravascular image frame 302. On the left side of Figure 3, an angiography frame 301 captured from the video signal is presented, and on the right side of Figure 3, an intravascular tomogra- phy image 302 showing a cross-section of a blood vessel is displayed. Below these images, along the bottom of Figure 3, is a horizontal view 303 showing the entire pullback, with each vertical line representing a frame taken at a particular angular plane passing through the center of the cross-sectional image. The angiography image 301 shown on the left side of Figure 3 is an x-ray image of the heart (or a portion of the heart, depending on the zoom factor) obtained from an angiography image that shows both the motion of the heart during the pullback and the motion of a radiopaque marker at the tip of the MM-OCT catheter (e.g., catheter / probe 120). While the views discussed herein may be angiography frames 301 and intravascular image frames 302, embodiments of the present disclosure are not limited thereto, and in one or more embodiments, one or more other imaging modalities may be used in place of angiography frames 301 and / or intravascular frames 302.

[0063] In one or more embodiments, the side-by-side views (e.g., angiographic image frame 301 and intravascular image frame 302, an image frame of one imaging modality described herein and an image frame of another imaging modality described herein, image frames of the same imaging modality, etc.) may represent synchronized images from two independent sources. For example, a first image (e.g., angiographic image frame 301, an image frame of another imaging modality, etc.) may be acquired from a first independent source, and a second image (e.g., intravascular image frame 302, an image frame from another imaging modality, etc.) may be acquired from a second independent source, such that the first and second sources are independent and / or distinct from one another. In embodiments using angiographic image frame 301 and intravascular image frame 302, the difference in latency between the two independent data sources is defined as an “angio delay time” (or delay time) and is used to display the synchronized image and any corresponding overlay graphical objects (e.g., position indicators, measurements, etc.) displayed on angiographic image 301. One or more embodiments operate to avoid any process that is computationally intensive and / or that produces error-prone results. For example, applying one or more co-registration methods to existing pullbacks can result in a computationally intensive and error-prone process. One or more processes of embodiments of the present disclosure can operate independently of one or more pullbacks of one or more catheters / probes (e.g., probe 120) and produce results that are not affected by the anatomical structure of the target, object, or sample (e.g., target, object, or sample 106 described herein). In one or more embodiments, the target, object, or sample can be a blood vessel.

[0064] One or more processes or methods of the present disclosure may function to measure angio delay or delay time in a particular mode (e.g., service mode) prior to taking any pullback. In any embodiment, one or more measurements may be designed with accuracy tolerances in mind to achieve a desired, set, or predetermined accuracy for the angio delay value (or delay time value), particularly considering one or more use settings (e.g., fixed settings) of the device or system used in any embodiment of the present disclosure.

[0065] In one or more embodiments, a GUI (graphical user interface) in a particular mode (e.g., service mode) can function as part of the device or system configuration to provide interactive and intuitive visualization as the user performs measurements and stores the results in a data table. When a new pullback is acquired and subsequently reviewed in another particular mode (e.g., review mode), such information can be used to properly synchronize the data from the angiogram and intravascular image (e.g., in one or more embodiments, without the need to perform additional co-registration processes). In one or more embodiments, one or more additional co-registration processes may be employed by the user as needed, such that any errors and intensive computations may be avoided.

[0066] In one or more embodiments, the angiographic delay time (or delay time) for an intravascular pullback image can be a characteristic independent of any individual pullback. The angiographic delay time (or delay time) can be determined by one or more components (e.g., one or more hardware components) of an imaging device or system (e.g., an MM-OCT device or system, an MM-OCT cart device or system, an OCT device or system, an OCT cart device or system, a system or device using one or more imaging modalities, etc.) and / or can be determined by one or more connections to the angiographic device or system in a particular operating room (OR). In one or more embodiments, once the angio delay time or delay time is determined for a particular imaging device or system configuration (e.g., an MM-OCT device or system, an MM-OCT cart device or system, an OCT device or system, an OCT cart device or system, a system or device using one or more imaging modalities, etc.) in an OR, the angio delay or delay time remains the same for all pullbacks obtained with the same configuration unless the imaging device or system is moved to another OR. Thus, embodiments of the present disclosure avoid errors that may occur due to the dependency of data on one or more pullbacks.

[0067] One or more embodiments may address or take into account angio delay latency (or delay time latency) when the display images are targeted at the same target, object, or sample (e.g., target, object, or sample 106) even when the display images are obtained from two different or independent sources / modalities.

[0068] In one or more embodiments, detection of any markers in an angiographic image can be performed independently of the motion and / or anatomical structure of the target, object, or sample (e.g., target, object, or sample 106). For example, one or more embodiments can detect marker locations independently of the motion and / or anatomical structure of the heart (or independently of the motion and / or anatomical structure of the coronary vessels). Thus, one or more embodiments of the present disclosure can enhance or improve the accuracy of locating markers in corresponding frames (e.g., compared to devices, systems, processes, etc. that do not use one or more of the features or techniques described herein).

[0069] One or more embodiments obtain or determine the angio delay (or delay time), adjust the angio delay or delay time, and perform synchronization using one or more processes or techniques that are clear and / or avoid user confusion.

[0070] One or more embodiments of the present disclosure function to synchronize two images (e.g., an intravascular image and an angiographic image, images of two imaging modalities, images of different imaging modalities, images of more than one imaging modality, etc.) on a display (e.g., an MM-OCT or OCT screen or display), such as display 1209 described below, during pullback. For example, the two images can be synchronized on the display at review time (e.g., in review mode).

[0071] In one or more embodiments, the intravascular image may be an OCT image, a MM-OCT image, a tomo image, a tomographic view of a cross section of a blood vessel (which may or may not include NIRF and / or NIRAF signals or data, if available). In the discussion of one or more embodiments herein, an "angiographic image" may be referred to interchangeably as an "angiographic image."

[0072] While not limited to any one device or system environment / condition, FIG. 1B illustrates an example in which an angio image and an intravascular image (e.g., an MM-OCT image and an OCT image) are captured through two independent paths with different inherent time delay characteristics. In FIG. 1B, image processor 50, processor 1200, or other processors described herein can receive both images from intravascular imaging system 40 and angiography system 30 and perform synchronization of the images on the display (e.g., side-by-side synchronization as illustrated in FIG. 3). Regarding the synchronization process, one or more defined terms are described herein to perform accurate calculations for visualization synchronization.

[0073] One or more embodiments of the present disclosure first establish a common starting point as a reference to define the delay times of the two independent paths. The reference or common starting point can be the time when a user clicks an icon or button on a GUI (e.g., a play icon or button, a start icon or button, another setting or predetermined icon or button, etc.) to trigger a pullback initiation event in the system or device. This is illustrated in FIG. 4A as time T (pullback occurrence). At this time, a patient interface unit (PIU) (e.g., PIU 110 of the present disclosure, as shown in any of FIGS. 1B, 5A, 8B, 12A-12C) and / or a catheter / probe (e.g., catheter / probe 120) controlled by an imaging system or device (e.g., an MM-OCT device or system, an MM-OCT cart device or system, an OCT device or system, an OCT cart device or system, a system or device using one or more imaging modalities, etc.) is rotating at a constant speed and is ready for image acquisition. Time point S (shown in FIG. 4A ) indicates a somewhat earlier time when the PIU starts the spin motor. The pullback occurrence event at time T, in one or more embodiments, functions to trigger the linear motor to reach a certain pullback speed (e.g., quickly or efficiently) and simultaneously begin collecting pullback frames. In one or more embodiments, the pullback frames can be acquired at a later time, such as at or near time point F (described below) (e.g., so that, in one or more embodiments, the pullback frame and image acquisition begin at or around the same time). Triggered by the same event, the acceleration of the linear motor is very fast, but it may take some time for the linear motor to ramp up from zero to its maximum speed. Meanwhile, the image (e.g., MM-OCT, OCT, other imaging modality, etc.) acquisition process can function to simultaneously begin at time (F) as shown in FIG. 4A , so that time point F is the “pullback start” line, which is later than the “pullback occurrence” time T by time t, as shown in FIG. 4A . In one or more embodiments, the first OCT / MM-OCT / other imaging modality image can be captured at time t.The linear motor acceleration path and the first OCT or MM-OCT (or other imaging modality) acquisition may follow different software and / or hardware paths. In one or more embodiments, the linear motor acceleration path and the first OCT or MM-OCT (or other imaging modality) acquisition may both reach the same pullback start point, where the linear motor reaches maximum speed and the first OCT / MM-OCT / imaging modality image acquisition is complete. This is reflected in FIG. 4A by the interval between T and F. In one or more embodiments, time L may be used to indicate the time when the last OCT / MM-OCT / other imaging modality image was acquired. In one or more embodiments, time F may be used as a reference point for the first OCT / MM-OCT / other imaging modality frame, and this time may be used to calculate the angio delay time.

[0074] In one or more embodiments, at the same time T, angio frames are collected from a frame grabber component. The frame grabber component is a source of angio frames in an imaging device or system (e.g., an MM-OCT device or system, an MM-OCT cart device or system, an OCT device or system, an OCT cart device or system, a system or device of one or more imaging modalities, etc.). In one or more embodiments, the OCT / MM-OCT software and / or one or more methods or processes use multiple threads to simultaneously control event responses. Thus, there is no delay in starting angio acquisition at time T when the initial initiation of the pullback event is triggered. In one or more embodiments, as soon as the first angio frame arrives, it can be considered the first available angio frame in that pullback. When considering the first acquired angio image, the arrival of the first angio image may be several OCT frames away from the first pullback frame (which may be time F), especially considering a relatively slow sample rate of approximately 30 fps. The position of the radiopaque marker can reflect a rest position where pullback has not yet been initiated. This may be true in one or more embodiments because the time delay through the angiopath is often greater than the delay incurred for acquiring an image (e.g., MM-OCT, OCT, another imaging modality, etc.). As shown on the timeline at the bottom of FIG. 4A , in one or more embodiments, the first angio image is captured in real time at time t1 (t1 being the time between time 0 and the time t1 at which the first angio image is captured), which in one or more embodiments is later than time t0 (which may be the same as time point F) at which the first OCT image is captured.However, due to a system data transfer delay t2 (t2 is the time between time 0 and time t2, as illustrated by the dotted line from time 0 to time t2), the angio image corresponding to the pullback initiation may actually be captured at td (shown on the "Angio Image Capture" axis), which may be later than the time of the first angio image capture (which is t1) by an additional delay interval t2 if additional delays (e.g., data transfer delays or other types of delays) exist. Using the pullback initiation ("Pullback Occurrence") at time T as the origin of the time reference (corresponding to time 0 shown in FIG. 4A), assuming the angio frame transfer path delay is t2, the total delay time is (t1-t0+t2), where time t0 is the system action trigger time between the button trigger and the first pullback image acquisition time, as previously described.

[0075] In one or more embodiments, the delay time inherent in an MM-OCT, OCT, or other intravascular imaging modality image is the time from when each MM-OCT, OCT, or other intravascular imaging modality frame acquisition is completed (from a processor or other component (e.g., an Optical Control Board (OCB), which may have a hardware, digital, or analog signal associated therewith) to when the frame is registered with a processor (e.g., processor or computer 1200, 1200′, 2, image processor 50, or other processor described herein) (or in a software component) as an image frame with a timestamp. The MM-OCT, OCT, or other intravascular imaging modality frame acquisition may have a constant rate of (FOCT) frames per second (FPS) (e.g., FOCT=200 FPS) or another predetermined or set amount during pullback. Consider a pullback in one embodiment, which may be 80 mm long, have a total duration of 2.0 seconds, and have an average frame resolution of approximately 0.2 mm per frame over a horizontal pullback distance. In one or more embodiments, one or more parameters may be different, such as a shorter length range. Another pullback contemplated in one or more embodiments is a slower pullback that covers a 50 mm pullback length over the same 2.0 second period. Preferably, in one or more embodiments, the rotation speed is still set or maintained at 200 FPS to provide a higher specific frame resolution of approximately 0.125 mm / frame.

[0076] By way of non-limiting example, in one or more embodiments, the angio-image delay time may be determined by one or more components that are largely external to the MM-OCT, OCT, intravascular imaging, or other imaging modality device or system (e.g., the intravascular imaging system 40 shown in at least FIGS. 1B, 5A, and 8B; the imaging device or system 20 shown in FIGS. 1B, 5A, and 8B; etc.). Additionally or alternatively, the angio-image delay time may be determined by one or more components that are part of the MM-OCT, OCT, intravascular imaging, or other imaging modality device or system (e.g., the intravascular imaging system 40 shown in at least FIGS. 1B, 5A, and 8B; the imaging device or system 20 shown in FIGS. 1B, 5A, and 8B; the angio system 30 shown in at least FIGS. 1B and 5A; any combination or portion thereof; other systems or devices described herein; etc.).

[0077] In one or more embodiments, the angio video frame rate may be slower than the frames of the MM-OCT, OCT, intravascular, or other imaging modality images, e.g., the standard 30 FPS for either a VGA (Video Graphics Array) or HDMI (High-Definition Multimedia Interface) video signal. In one or more embodiments, higher frame rates up to 120 Hz may be supported for HDMI. The video signal may then travel through a central operating room boom or equipment management device / system and long cables to a video acquisition board (frame grabber) of the MM-OCT, OCT, intravascular, or other imaging modality cart device or system (e.g., at least the intravascular imaging system 40 shown in FIGS. 1B, 5A, and 8B; the imaging device or system 20 shown in FIGS. 1B, 5A, and 8B; any combination or portion thereof (e.g., another subsystem or system of the device or system 20, or other components or features described herein); etc.). The video acquisition board or frame grabber digitally frames the video signal. The system may function to capture the digital frame as a timestamp and register the digital frame in software or a processor (e.g., processor or computer 1200, 1200', 2, image processor 50, or other processors described herein) along with a timestamp from the device / system clock. In one or more embodiments, it may take additional time to display the image on a screen or display. However, the timestamp is a parameter that can be used to adjust the relative association and order of MM-OCT, OCT, intravascular, and other imaging modality frames when the frames are displayed together in a GUI.

[0078] In one or more embodiments, to perform angiography image synchronization, a relative delay between the availability delay of an MM-OCT image, OCT image, intravascular image, or other imaging modality frame image and the availability delay of an angio frame image (e.g., the availability delay of an MM-OCT image, OCT image, intravascular image, or other imaging modality image minus the availability delay of an angio frame image) can be calculated, determined, or obtained. In one or more embodiments, the sampling rates of angiography image frame acquisition and MM-OCT image, OCT image, intravascular image, or other imaging modality frame acquisition may be different, and the difference in sampling rates may affect accuracy, with the slower sample rate potentially determining the accuracy of the results. Thus, in one or more embodiments, the delay time may also take into account the difference in sample rates. In one or more embodiments, the target time for synchronization of each frame may be set as the midpoint of each frame acquisition. In one or more embodiments, for each angio frame, the temporal resolution may be half of 1 / 30 FPS, which is approximately 16.7 ms in time, corresponding to a distance of 0.67 mm along the pullback direction. In one or more embodiments, 30 FPS in angio images may cover approximately 71 OCT pullback frames.

[0079] As at least one example, FIG. 4B illustrates a natural image frame mapping pattern between an intravascular OCT / NIRAF image and an angiography video frame due to potentially different sampling frequencies. While the relative delay time shift may be much longer than a single angio video frame interval, in one or more embodiments, registration accuracy may be acceptable within the high-frequency frame interval of OCT / NIRAF frames (approximately 5 ms). As shown in FIG. 4B, each frame data packet may contain one OCT / NIRAF frame, but not all frame data packets may contain a video frame. For example, but not limited to, the first five frame data packets may each contain an OCT / NIRAF frame, and the sixth data packet may contain a video frame and an OCT / NIRAF frame (as shown in FIG. 4B).

[0080] In summary, the relative angio delay time is defined / influenced by and / or determined using numerous factors involved in the operating room (OR) environment of the MM-OCT, OCT, intravascular imaging, or other imaging modality device or system (e.g., at least the intravascular imaging system 40 shown in FIGS. 1B, 5A, and 8B; the imaging device or system 20 shown in FIGS. 1B, 5A, and 8B; the angio system 30 shown in FIGS. 1B and 5A; any combination or portion thereof; etc.). In one or more embodiments, factors external to the device / system (e.g., the angiographic imaging pathway) exhibit greater delay than factors internal to the MM-OCT, OCT, intravascular imaging, or other imaging modality device / system (e.g., at least the intravascular imaging system 40 shown in FIGS. 1B, 5A, and 8B; the imaging device or system 20 shown in FIGS. 1B, 5A, and 8B; any combination or portion thereof; etc.). Considering a fixed setup, at least one dominant factor may be the OR / room environment, and each OR / room may be different. Based on the above discussion, the present disclosure provides the following method for estimating the relative angio delay time (or delay time) and applying the relative angio delay time (or delay time) to synchronize images of MM-OCT, OCT, intravascular, and other imaging modalities with angio frames.

[0081] In one or more embodiments, the angio delay (or delay time) can be measured using a controlled pullback. Because the angio delay (or delay time) is a relative value, the pullback settings of the MM-OCT, OCT, intravascular, or other imaging modality device / system (e.g., an intravascular imaging system 40 such as shown in at least FIGS. 1B, 5A, and 8B; an imaging device or system 20 such as shown in FIGS. 1B, 5A, and 8B; any combination or portion thereof, etc.) can be used to measure the delay time, taking into account the following conditions and settings: In one or more embodiments, the first MM-OCT, OCT, intravascular, or other imaging modality image acquisition can occur within a single MM-OCT, OCT, intravascular, or other imaging modality image acquisition cycle when the pullback is initiated, during which the maximum pullback speed can be reached. In one or more embodiments, the angio image acquisition process can occur simultaneously and continuously, so the first angio image registered by the device or system can be the image before the pullback operation begins. In one or more embodiments, the angio delay (or delay time) may be greater than the time interval of several angio frames, so that subsequent angio images may show the marker position in exactly the same location, thereby confirming that pullback has not yet begun.

[0082] When pullback begins, in one or more embodiments, the acceleration phase may be very short and may be covered within the angio sample interval. In one or more embodiments, the acceleration phase may be very short and may be covered within the angio sample interval. Comparing the first two adjacent angio frames allows the distance traveled during this period to be determined. If pullback continues at a constant speed during the next sample interval, the distance traveled may be (Vp*Cta), which is 0.67 mm as calculated above, where Vp is the speed of pullback (i.e., 20 mm / s) and Cta is the inverse of the angio sampling rate (i.e., 1 / 30 second, which corresponds to 2 / 3 mm).

[0083] If one or more settings are considered such that the field of view (FOV) of the angio image is approximately 100 mm (corresponding to approximately 1,024 pixels on the image) depending on the zoom factor, the resolution of each pixel on the angio image is approximately 0.1 mm. Therefore, movement between the two angio images may be readily apparent. If the first two angio images show a distance shorter than 0.67 mm, the start time of the pullback can be interpolated to the subangio interval level, allowing for more accurate matching of the timestamps between the first MM-OCT, OCT, intravascular, or other imaging modality frame and the two adjacent angio images.

[0084] Since there are more or multiple angio frames available for each pullback, multiple frames can be used to identify the marker locations, and then simple linear regression can be used to calculate the starting point (e.g., where the marker begins to move). One or more embodiments of a process for estimating or determining angio delay time (or delay time) may include one or more of the following steps (see, e.g., FIG. 6): a) Preparing a test catheter / probe (e.g., catheter / probe 120, other probes / catheters described herein, etc.) having a wireless marker visible by or through the angio image (e.g., an angio-opaque marker, a marker, a wireless marker known to one of skill in the art, other markers described herein, etc.) (see, e.g., step S601 of FIG. 6). Establishing a straight or predetermined path for pullback. In FIGS. 5A-5B, the angio image displayed (in FIG. 5B) shows an example of a straight pullback along the Y-axis (e.g., using the device or system shown in FIG. 5A; the device or system can be used with other embodiments described herein; one or more features described herein (whether described individually or together) can be used as and / or with the device or system; etc.), and a visible ruler is displayed next to the visible marker in the angiogram. Additionally, one or more embodiments may employ an alternative setup for performing a linear pullback diagonally, i.e., at a 45-degree angle relative to the X, Y coordinates of the angio image. This alternative embodiment may maximize spatial resolution and achieve a slightly higher specific resolution (compared to embodiments using a pullback along the Y axis). Furthermore, one or more embodiments may adjust the FOV of the angio image to its minimum limit, i.e., maximize the zoom factor and therefore the pixel resolution. The ruler along the path is optional in one or more embodiments. The ruler serves to verify the actual pullback length and / or calibrate the specific resolution of the angio image. This may be useful when parameters associated with an MM-OCT, OCT, intravascular imaging, or other imaging modality device or system (e.g., at least the intravascular imaging system 40 shown in FIGS. 1B, 5A, and 8B; the imaging device or system 20 shown in FIGS. 1B, 5A, and 8B; any combination or portion thereof; etc.) have not yet been calibrated or may need to be recalibrated.However, in one or more embodiments, angio delay calculations may not be employed when distances on an angio image are proportional to the frame time interval. Although various features of one or more imaging devices or systems are described herein, such imaging devices or systems are not limited thereto and may be suitably modified to use any feature described herein or any combination of features of the present disclosure. b) Performing a pullback and reviewing the data (see, e.g., step S602 of FIG. 6) to assess whether there is an option for a shorter pullback. In one or more embodiments, using a 2 mm or 0.5 second pullback for a total of 100 frames may be sufficient. In one or more embodiments, there may be approximately 15 angio images associated with an example pullback. c) identifying and / or labeling marker locations within the angio frame with sufficient precision (see, e.g., step S603 of FIG. 6 ). For example, in one or more embodiments, the method may further include one or more of: starting in a special review mode in the service mode; examining each of the angio images; and marking (or using a label tool to mark) the locations of the radiopaque markers. In one or more embodiments, the locations may be predetermined or preset locations of the radiopaque markers, such as the center locations of each of the radiopaque markers. The radiopaque markers are accurately identified and / or marked using a processor (e.g., processor 1200, 1200′, 2, etc.; image processor 50; other processors described herein; etc.). The image viewer and / or processor (e.g., processor 1200, 1200′, 2, etc.; image processor 50; other processors described herein; etc.) may further magnify the angio image so that the marked center locations reach sub-pixel precision. d) Applying linear regression to calculate the segment start time when the marker begins to move (see, e.g., step S604 of FIG. 6). Based on the processor-labeled or user-labeled locations, one or more linear regression method embodiments may further include performing a simple linear regression analysis and determining the start frame location in terms of timestamps. Additionally, the results may (and in one or more method embodiments may also) include an error metric calculation, such as RMSE (root mean square). e) Estimating an angio delay time (see, e.g., step S605 of FIG. 6 ). For example, in one or more embodiments, the estimating step may include estimating an angio delay time (or delay time) and an associated tolerance, and if the estimated angio delay time and / or associated tolerance is acceptable or falls within acceptable threshold limits, the angio delay time (or delay time) and / or associated tolerance are entered into a results table (at least one example of a results table is shown in FIG. 11 , described below). In one or more embodiments, the angio delay time (or delay time) may be estimated as the interpolated starting frame timestamp calculated above minus the timestamp of the first MM-OCT, OCT, intravascular, or other imaging modality image being pulled back.

[0085] One or more embodiments of the method for measuring angio delay (or delay time) using a controlled pullback may function using, but not be limited to, the condition that the horizontal speed of the pullback is reached as quickly as the first frame is completed. Otherwise, the error may be larger than the interval between one MM-OCT, OCT, intravascular, or other imaging modality image. Given the much lower sample rate of the angio frame, such an error may still be acceptable within a practical or useful tolerance range. In one or more embodiments, the MM-OCT image may not be used at all. Again, if a direct synchronization signal can be established between the MM-OCT, OCT, intravascular, or other imaging modality frame and the angio frame, an estimate of the angio delay (or delay time) may be much easier to determine, simplifying the calculation.

[0086] In one or more embodiments, angio delay (or delay time) can be measured using a synchronization signal between both the image and angio image streams of MM-OCT, OCT, intravascular, or other imaging modalities. For example, one or more embodiments may use or include a rotating device operable to measure angio delay intervals, such as the device or other features described in U.S. Patent Application No. 17 / 831,018 (filed June 2, 2022, incorporated herein by reference in its entirety). When using a synchronization signal, angio delay can be measured by comparing the time intervals observed by pullbacks (e.g., MM-OCT pullback and OCT pullback) for the same event. At least one embodiment of the rotating device may be comprised of two round metal plates, both of which have holes of the same shape (e.g., triangular, trapezoidal, or other geometric shape). A first plate is fixed to a base (or elsewhere on the rotating instrument), and a second plate operates to rotate about an axis on (or adjacent to) the second plate (see, e.g., axis 75 shown in FIG. 7B). FIG. 7A shows at least one embodiment of a top view of each of two disks or plates 71, 72 of the rotating instrument 70, and FIG. 7B shows a side view of the rotating instrument 70. An angio image, in one or more embodiments, functions to view the combined top view of the rotating instrument 70. Plate 71 functions as a shutter body that rotates about axis 75 (see, e.g., FIG. 7B) extending through hole 76, and plate 71 also has hole 73. The rotating instrument 70 may include a motor M that functions to rotate rotating plate 71. Plate 72 has hole 74, and plate 72 functions as a stationary body. In one or more embodiments, holes 73, 74 are the same size and shape. When plate 71 is rotated to another angle so that holes 73 and 74 no longer overlap, X-rays are blocked by metal plates 71 and 72, resulting in a dark circle appearing in the angiogram (see, for example, the right image in Figure 8A). When two holes 73 and 74 in plates 71 and 72 overlap each other, holes 73 and 74 form a shaped hole (e.g., triangular, trapezoidal, or other geometric shape) through which X-rays can pass directly.Thus, the angio image will show a bright region 81 (e.g., triangular, trapezoidal, or other geometric shape) shaped within a dark circle (see, e.g., the left image in FIG. 8A ). The region reaches a maximum area (also called a maximum overlap region) when the two holes 73, 74 completely overlap, resulting in the region having a similar shape (e.g., triangular, trapezoidal, or other geometric shape) compared to the holes 73, 74. When the two holes 73, 74 overlap (partially or completely), resulting in a bright region in the angio image, the shutter is considered open, allowing X-rays to pass through the holes 73, 74. When the two holes 73, 74 do not overlap at all, resulting in a completely dark circle (see, e.g., the right image in FIG. 8A ), the shutter is considered closed, preventing X-rays from passing through the holes 73, 74. As previously mentioned, the rotating plate 71 can be driven by a motor M using a connector 76. In one or more embodiments, the rotation speed of the motor M need not be very fast. For example, plate 71 may rotate at approximately 20 revolutions per second or less to ensure sufficient time intervals for angio delay measurements. In one or more embodiments, plate 71 of rotating device 70 may be manually driven and may reach speeds of approximately 5-10 revolutions per second, gradually slowing down due to friction. In one or more embodiments, the aperture may be 1 / 8 of a circle (or other geometric shape), so that peak signals in the angio image may be approximately 1 / 80 to 1 / 40 of a second between repeating peaks, which is approximately half the frame rate, so that peak signals in the angio image may be easily visible. This type of speed allows angio delay measurements to be calculated within the time periods of adjacent peak signals. Rotating device 70 may also include a switch connector element 77 (see FIG. 7B). Switch connector element 77 may be an electrical switch that operates to connect for short periods at a time or when the shutter is open to a predetermined size. In one or more embodiments, the predetermined size may be the maximum size of the shutter. The expected angio image when the shutter is opened to a predetermined size, which in at least one embodiment is the maximum size, is illustrated in FIG. 8A.The left image in Figure 8A shows an angio image with the shutter open, with the two holes 73, 74 overlapping (e.g., completely), and the right image in Figure 8A shows an angio image with the shutter closed, with the two holes 73, 74 not overlapping at all. In one or more embodiments, the plates 71, 72 may be reversed so that one or more of the following occurs: (i) the motor is located on the side of plate 71 that is positioned away from (or opposite from) plate 72; and / or (ii) the X-ray direction approaches instrument 70 toward the side with stationary plate 72 (e.g., from the opposite side of instrument 70).

[0087] When the maximum overlap area is reached, the rotating device 70 may further include a switch 78 that interacts with both plates 71, 72, operative to briefly connect the plates 71, 72 during peak times. As previously mentioned, the switch connector element 77 may be a stationary element fixed to the plate 72, or the switch connector element 77 may establish an electrical connection to a lamp 79 on the plate 72, facing toward or opposite the plate 71. The movable plate 71 may have a lamp 78 facing toward or opposite the plate 72, which functions to contact the lamp 79 to form a closed switch when the lamps 78, 79 meet during rotation. The switch connector element 77 may have another fixed electrical connector that operates to contact both lamps 78, 79 simultaneously when they meet. Both positions of the lamps 78, 79 are shown in FIG. 7A. The switch is in a connected state when lamp 78 contacts fixed connector lamp 79 on plate 72 at the same or a similar location. Otherwise, the switch state may be disconnected. Switch connector element 77 may have one or more (e.g., two) wires extending therefrom as an electrical switch, which are connected to a circuit that illuminates a special light-emitting diode (LED) 82 (see, e.g., FIG. 8B ) that emits near-infrared (NIRF) fluorescence or near-infrared autofluorescence (NIRAF) that can be detected by a sensor in a component (e.g., a NIRF / NIRAF subsystem; one or more components shown in FIG. 8B ; etc.) of (or in communication with or used in conjunction with) an MM-OCT, OCT, intravascular, or other imaging modality device / system (e.g., at least intravascular imaging system 40 shown in FIGS. 1B, 5A, and 8B ; imaging device or system 20 shown in FIGS. 1B, 5A, and 8B ; any combination or portion thereof; etc.). In one or more embodiments, the electrical circuitry may be etched (see, for example, etching E shown on plate 71 on the left side of FIG. 7A).The NIRF / NIRAF signals may be sampled at a high frequency and encoded into data captured by one or more sensors (or other hardware components, such as an Alazar digitizer) of a device / system of an MM-OCT, OCT, intravascular, or other imaging modality (e.g., an intravascular imaging system 40 shown at least in Figures 1B, 5A, and 8B; an angio system 30 shown at least in Figures 1B and 5A; an imaging device or system 20 shown in Figures 1B, 5A, and 8B; any combination or portion thereof; etc.). The LED 82, operable to emit NIRF / NIRAF light, may be located anywhere in, on, or near the MM-OCT, OCT, intravascular, or other imaging modality device / system (e.g., the intravascular imaging system 40 shown at least in FIGS. 1B, 5A, and 8B; the angio system 30 shown at least in FIGS. 1B and 5A; the imaging device or system 20 shown at least in FIGS. 1B, 5A, and 8B; any combination or portion thereof; etc.). For example, but not limited to, the LED 82 may be located on the side (or handle) of the PIU 110, as shown in FIG. 8B. Ultimately, the NIRF / NIRAF signal is stored as frame data as part of the MM-OCT, OCT, intravascular, or other imaging modality. In one or more embodiments, once the rotational speed of the device 70 has stabilized, the LED light 82 is illuminated and the area peaks physically coincide. Thus, in an MM-OCT, OCT, intravascular, or other imaging modality device / system (e.g., an intravascular imaging system 40 shown at least in Figures 1B, 5A, and 8B; an angio system 30 shown at least in Figures 1B and 5A; an imaging device or system 20 shown in Figures 1B, 5A, and 8B; any combination or portion thereof; etc.), the time delay present can be detected by checking the difference in peak timestamps between the NIRF / NIRAF signal and the corresponding NIRF / NIRAF optical signal on the MM-OCT, OCT, intravascular, or other imaging modality image.The NIRF / NIRAF LEDs 82 may be housed or contained in a specialized catheter 140 with an electrical circuit connection to the device 70 and the environment of use illustrated in FIG. 8B. In one or more embodiments, one or more windows or apertures 81 may be used, where the disk 71 may have multiple holes 73 and the disk 72 may have multiple holes 74, each overlapping with one another to form multiple windows or apertures 81 (see, e.g., FIG. 8B). Such an embodiment allows for the use of more x-ray data and / or more NIRF / NIRAF data to improve accuracy.

[0088] At least one embodiment of a process for using rotating device 70 to measure angio delay (or delay time) is shown in the flowchart of FIG. 10. The signal analysis portion of at least one process embodiment is further described as follows: When plate 71 of device 70 rotates at a specific, predetermined, or set speed, angio-video images captured by one or more processors (e.g., processors 1200, 1200′, 2, image processor 50, etc.) and / or a frame grabber function to display overlapping holes 73, 74 from a closed or shuttered state (see, e.g., the right image in FIG. 8A ) to a maximum area of ​​full overlap with at least one aperture or area 81 (see, e.g., the open-shutter configuration in the left image in FIG. 8A ), and then closing to zero with each rotation. One or more image processing methods or algorithms can be used to measure the area of ​​the window or aperture 81 in each successive image frame, which should result in a signal with a triangular-shaped pulse with each rotation, as shown in FIG. 9. The triangular peak 90 corresponds to the maximum window area when the two holes 73, 74 completely overlap. In one or more embodiments, the sum of the areas within the disks or plates 71, 72 of the angiographic images over time can be a triangular signal. Simultaneously, the NIRF / NIRAF LED light 82 can be illuminated by the switch mechanism described above with respect to the switch connector element 77 and lamps 78, 79. In one or more embodiments, the corresponding NIRF / NIRAF light signal on the image can be a rectangular signal, such as the rectangular signal shown in FIG. 9 (in one or more embodiments, the NIRF / NIRAF signal can have a square or other geometric shape). In one or more embodiments, the peak time (or the time at which the maximum window area is reached, such that the triangular signal peak 90 exists) can coincide with the center (or other predetermined portion) 91 of the rectangular NIRF / NIRAF signal, as shown in FIG. 9 . From the perspective of the image of one or more MM-OCT, OCT, intravascular, or other imaging modalities, the rectangular signal can consist of multiple frames for which NIRF / NIRAF signals are available.For example, in one or more embodiments, the NIRF / NIRAF signal may appear at the outer edge of the FOV (e.g., a circular FOV) of a tomo image. Because the on / off nature of light 82 resembles a binary signal, light 82 can serve to indicate whether a NIRF / NIRAF signal is available, and such information can be used to determine the start and end frames of the rectangular signal with accuracy of a single frame interval for MM-OCT, OCT, intravascular, and other imaging modalities. Furthermore, as shown in Figure 9, when both triangular and rectangular signals are obtained on two time axes from an MM-OCT, OCT, intravascular or other imaging modality device / system (e.g., an intravascular imaging system 40 shown at least in Figures 1B, 5A and 8B; an angio system 30 shown at least in Figures 1B and 5A; an imaging device or system 20 shown in Figures 1B, 5A and 8B; a NIRF / NIRAF device, system or subsystem 70; any combination or portion thereof; etc.), the angio delay time can be calculated from the two time axes, for example, using the value or time difference dt between the respective centers 91 and peaks 90.

[0089] For an angiography image, the peak of the largest area (e.g., a triangular or other shaped signal peak 90) may not be exactly on the frame in one or more embodiments. Therefore, in one or more embodiments, the peak 90 may be interpolated using neighboring triangular area values ​​to achieve greater accuracy in the location of the peak 90. ​​On the other hand, because the resolution of the frames of MM-OCT, OCT, intravascular, and other imaging modalities may be higher than the resolution of the angiography frames, in one or more embodiments, the location of the center of the rectangular signal may be accurately determined by determining the start and end frames of the MM-OCT, OCT, intravascular, and other imaging modality frames. Next, a determination can be made as to whether NIRF / NIRAF light is present on the frame, thereby determining the center position (or center frame) or middle position (or middle frame) of the NIRF / NIRAF signal (or rectangular-shaped NIRF / NIRAF signal). The time difference between the timestamp of the middle frame and the timestamp corresponding to the peak of the triangular signal is the estimated angio delay we are looking for.

[0090] As at least one example shown in FIG. 10 , one or more methods for determining angio delay (or delay time) may include one or more of the following: (i) an apparatus or system (e.g., an imaging system 40 for intravascular, OCT, MM-OCT, or other imaging modality shown at least in FIGS. 1B , 5A , and 8B ; an angio system 30 shown at least in FIGS. 1B and 5A ; an imaging apparatus or system 20 shown at least in FIGS. 1B , 5A , and 8B ; a NIRF / NIRAF instrument, system, or subsystem 70 (e.g., FIGS. 7A-8B ); (ii) preparing a catheter (e.g., catheter or probe 140 shown in FIG. 8B, other catheters or probes described herein, etc.) with NIRF / NIRAF light and / or preparing to rotate a wheel or disk (e.g., wheel or disk 71) of a rotating device (e.g., device 70) by pullback (e.g., see step S1001 of FIG. 10); (ii) initiating pullback, turning on the NIRF / NIRAF light, and rotating the spinning wheel or disk (e.g., wheel or disk 71). (iii) detecting frames containing open windows or regions (e.g., open region 81) on or using the angio frame and calculating the open region (e.g., open region 81) for each frame (e.g., see step S1003 in FIG. 10); (iv) using NIRF / NIRAF light on or using one or more MM-OCT, OCT, intravascular or other imaging modality images or frames; and detecting frames in which the NIRF / NIRAF optical signal is on by finding the center or middle (e.g., middle frame) (or other predetermined portion) of the NIRF / NIRAF signal (see, for example, step S1004 in FIG. 10 ); and / or (v) detecting signals from one or more open regions of one or more angio images (e.g., corresponding to the total area value in the angio images over time; corresponding to the size of the open region 81; corresponding to the size of the open region 81 expressed as the amount of overlap of at least holes 73, 74 of the device 70;etc.) (e.g., the signal may be acquired or received based on data from a rotating device (e.g., rotating device 70)), determining a peak time (e.g., the time that may occur when holes 73, 74 of device 70 are completely overlapped; the time that may occur when open area 81 is at its maximum size; etc.), determining or identifying a corresponding time value for a corresponding portion / position (e.g., intermediate frame or center value or position, etc.) of the NIRF / NIRAF optical signal (e.g., the portion / position of the NIRF / NIRAF optical signal corresponds to a peak of a signal obtained from one or more angio images), and calculating an angio delay time (or delay time) by calculating the time difference between the peak time and the determined or identified time of the corresponding portion / position of the NIRF / NIRAF optical signal (see, e.g., step S1005 of FIG. 10 );

[0091] One or more embodiments of the present disclosure may use delay time measurement and configuration management features (e.g., using such features in conjunction with a user interface or GUI, such as GUI 1100 shown in FIG. 11 ). In one or more embodiments, a GUI component is designed to manage angio delay time information for multiple ORs (operating rooms), so that an MM-OCT, OCT, intravascular, or other imaging modality cart device or system can be used in various locations whenever needed. When a service team delivers an MM-OCT, OCT, intravascular, or other imaging modality device or system to a specific location, an initialization process may request that all rooms (e.g., ORs) that will be used with the device or system be added or included. A procedure is performed or employed to measure angio delay times for each room to be evaluated, so that accurate angio delay compensation is applied to all pullbacks performed in each room to be evaluated. When adding an OR to the present device or system (e.g., the intravascular imaging system 40 shown at least in Figures 1B, 5A, and 8B; the angio system 30 shown at least in Figures 1B and 5A; the imaging device or system 20 shown at least in Figures 1B, 5A, and 8B; the NIRF / NIRAF instrument, system, or subsystem 70; any combination or portion thereof; other systems or devices described herein; etc.), multiple angio delay measurements may be performed, the difference between which is preferably within a tolerance of about ±0.02 seconds or ±0.02 seconds (in one or more embodiments, corresponding to one frame of MM-OCT, OCT, intravascular, or other imaging modality in the pullback).

[0092] In one or more embodiments, the angio delay time may be considered part of the configuration information of an MM-OCT, OCT, intravascular, or other imaging modality device / system (e.g., the intravascular imaging system 40 shown at least in FIGS. 1B, 5A, and 8B; the angio system 30 shown at least in FIGS. 1B and 5A; the imaging device or system 20 shown at least in FIGS. 1B, 5A, and 8B; the NIRF / NIRAF device, system, or subsystem 70; any combination or portion thereof; etc.). To create such a record, an operator or user of an MM-OCT, OCT, intravascular, or other imaging modality device / system (e.g., the intravascular imaging system 40 shown at least in FIGS. 1B, 5A, and 8B; the angio system 30 shown at least in FIGS. 1B and 5A; the imaging device or system 20 shown at least in FIGS. 1B, 5A, and 8B; the NIRF / NIRAF device, system, or subsystem 70; any combination or portion thereof; etc.) may follow software and / or hardware procedures. First, a user or operator can move the cart into the OR and connect all the equipment in the environment to obtain pullbacks for MM-OCT, OCT, intravascular, and other imaging modalities. Second, a corresponding catheter or device (e.g., catheter 120, catheter 140, device 70, etc.) can be appropriately connected to the MM-OCT, OCT, intravascular, and other imaging modality device / system (e.g., intravascular imaging system 40 shown at least in FIGS. 1B, 5A, and 8B; angio system 30 shown at least in FIGS. 1B and 5A; imaging device or system 20 shown at least in FIGS. 1B, 5A, and 8B; NIRF / NIRAF device, system, or subsystem 70; any combination or portion thereof; etc.). Next, the operator or user can perform pullbacks using the angio view and display angio images / frames and / or MM-OCT, OCT, intravascular, and other imaging modality images / frames side-by-side on the screen.In one or more embodiments using the above-described process for measuring angio delay using controlled pullback, a user or controller can label radiopaque markers on multiple angio images. Software and / or one or more processors (e.g., processors 1200, 1200', 2, etc.; imaging processor 50; other processors described herein; etc.) can then operate to calculate the angio delay (or delay time) measurements and enter that information, along with test-related information, into a table. In one or more embodiments using the above-described process for measuring angio delay (or delay time) using synchronization signals, a user or controller can identify the center / middle (or other predetermined or set location) of a frame (which can be calculated from an angio image with a triangular, trapezoidal, or other geometrically desirable hole) of a MM-OCT, OCT, intravascular, or other imaging modality device / system (e.g., intravascular imaging system 40 shown in at least FIGS. 1B, 5A, and 8B; angio system 30 shown in at least FIGS. 1B and 5A; imaging device or system 20 shown in FIGS. 1B, 5A, and 8B; NIRF / NIRAF device, system, or subsystem 70; any combination or portion thereof; etc.) where a NIRF / NIRAF signal is available and where the area measurement curve or signal exhibits a peak occurrence. Software and / or one or more processors (e.g., processors 1200, 1200′, 2, etc.; imaging processor 50; other processors described herein; etc.) can then record the calculated angio delay values ​​in the same table. Finally, multiple pullbacks and measurement processes can be performed and the average calculated as the acceptable delay to be used for this particular OR. At the same time, a user or operator may check and verify any variations in the results, and / or one or more processors (e.g., processors 1200, 1200', 2, etc.; imaging processor 50; other processors described herein; etc.) can function to automatically check and verify that the results are within acceptable set ranges or limits.If the differences between some tests are too large compared to other tests or exceed predetermined / set limits / ranges, one or more processors (e.g., processors 1200, 1200', 2, etc.; imaging processor 50; other processors described herein; etc.) and / or a user or operator can eliminate the excessive differences and repeat similar tests to obtain the desired average value.

[0093] As previously mentioned, FIG. 11 illustrates at least one embodiment of a GUI 1100 showing an example of a group of angio delay measurements associated with a particular OR named "Op Room A." This GUI 1100 allows a user to add, edit, and delete rooms from a list of rooms (which can be viewed and modified using drop-down menu icon 1102). Each room is preferably associated with one or more groups of angio delay measurements. Once the measurement process is complete, the user or operator can accept the average values ​​by clicking an "Update" button, or one or more processors (e.g., processors 1200, 1200', 2, etc.; imaging processor 50; other processors described herein; etc.) can automatically accept the average values. Such values ​​can be used by the configuration manager to make adjustments for future pullbacks acquired by devices or systems within this OR (e.g., the intravascular imaging system 40 shown in at least FIGS. 1B, 5A, and 8B; the angio system 30 shown in at least FIGS. 1B and 5A; the imaging device or system 20 shown in FIGS. 1B, 5A, and 8B; the NIRF / NIRAF instrument, system, or subsystem 70; any combination or portion thereof; etc.). As displayed in the "Angio Delay" tab, the current room is "Op Room A," as previously described, the frame grabber delay offset is displayed as 162 ms (although this may be changed automatically by one or more processors described herein or manually by a user or operator as appropriate), the delay offset count is "3," and the average offset is 165.0. The displayed data includes data from three tests: Tests 1, 2, and 3. The delay offsets (ms) are displayed as 159 ms, 165 ms, and 173 ms, respectively. The test date and time for the three tests are also recorded, as shown in Figure 11, although in one or more embodiments such information may not be used or required. For each test, the person who administered the test may be listed.GUI 1100 also includes a device or system dashboard, a status and test page, a firmware update page, and a log file page, as shown on the right side of Figure 11. The user or controller can also restore default values ​​or save data, as indicated by the icons in the lower right of Figure 11. While GUI 1100 can operate in a service mode as described herein, GUI 1100 can also operate outside of the service mode, such as allowing the user or controller to check angio delay values ​​associated with pullbacks in a review mode or to switch to different configured ORs.

[0094] One or more embodiments of the synchronization and / or delay measurement techniques and / or one or more imaging techniques described herein can be used in conjunction with optical probe applications, according to one or more aspects of the present disclosure. System 100 includes a light source 101, a reference arm 102, a sample arm 103, a splitter 104 (also referred to herein as a "beam splitter"), a reference mirror (also referred to herein as a "reference reflection") 105, and one or more detectors 107. System 100 may include a phase-shifting device or unit 130, although in one or more embodiments, the phase-shifting device or unit may be omitted. In one or more embodiments, system 100 may include a patient interface device or unit ("PIU") 110 and a catheter or probe 120 (schematically shown in at least FIGS. 1B-2, 5A, and 12A), and system 100 may interact with a sample or target 106 (e.g., via catheter / probe 120 and / or PIU 110). In one or more embodiments, system 100 includes an interferometer, or an interferometer is defined by one or more components of system 100, such as at least light source 101, reference arm 102, sample arm 103, splitter 104, and reference mirror 105.

[0095] The light source 101 functions to produce light to the splitter 104, which separates the light from the light source 101 into a reference beam that enters the reference arm 102 and a sample beam that enters the sample arm 103. The beam splitter 104 is positioned or arranged at an angle relative to the reference mirror 105, one or more detectors 107, and the sample, object, or target 106. The reference beam passes through a phase shift unit 130 (if included in the system, as shown in system 100), and the reference beam is reflected off the reference mirror 105 in the reference arm 102. Meanwhile, the sample beam is reflected or scattered off the sample, object, or target 106 through a patient interface unit (PIU; also referred to herein as a patient interface component (PIC)) 110 and catheter 120 in the sample arm 103. In one or more embodiments, the phase shift unit 130 may be omitted from the instrument or system, as appropriate. Both the reference beam and the sample beam are combined (or recombined) at splitter 104, producing an interference pattern. The output of system 100 and / or its interferometer is continuously acquired by one or more detectors 107 (e.g., photodiodes, cameras, multi-array cameras, etc.). The one or more detectors 107 measure the interference or interference pattern between the two combined or recombined radiation or light beams. In one or more embodiments, the reference beam and the sample beam travel different optical path lengths, so that a fringe effect is created and can be measured by one or more detectors 107. Electrical analog signals obtained from the output of system 100 and / or its interferometer are converted to digital signals and analyzed by a computer, such as computer 1200 or 1200′ (shown in FIG. 14 or FIG. 15, respectively, described below). In one or more embodiments, light source 101 may be a radiation source or a broadband light source emitting light over a wide range of wavelengths. In one or more embodiments, a Fourier analyzer, including software and electronics, can be used to convert the electrical analog signals into an optical spectrum.In one or more embodiments including a rotating device 70 and a catheter 140 connected to the PIU 110 (see, e.g., FIG. 8B ), one or more detectors 107 and one or more processors or computers (e.g., 1200, 1200′, 2, image processor 50, other processors or computers described herein, etc.) further function to receive signals / data from the rotating device 70 via the PIU 110.

[0096] Light source 101 and / or LED 82 may include multiple light sources or may be a single light source. In one or more embodiments, light source 101 generates broadband laser light. Light source 101 may include any light-emitting component, such as one or more of a laser, an organic light-emitting diode (OLED), a light-emitting diode (LED), a halogen lamp, an incandescent lamp, a laser-pumped supercontinuous light source, and / or a fluorescent lamp. Light source 101 may be any light source that provides light that can be separated into at least three bands, each of which is further dispersed to provide light used for spectral encoding of spatial information. Light source 101 may be any light source that provides light that, after dispersion, is used for imaging, controlling an imaging modality, displaying, modifying, performing methods of enhancement, constructing or reconstructing 3D structures, and / or other methods described herein. The light source 101 may be fiber coupled or free-space coupled to other components of one or more systems discussed herein (e.g., system 100, system 100', system 100", system 100'", etc.). The light source 101 may be a swept-source (SS) light source. The LED 82 may include any one or more of the features of the light source 101 described herein.

[0097] According to at least one aspect of the present disclosure, the functionality of an OCT device or system is implemented using optical fibers. As previously mentioned, one application of the OCT techniques of the present disclosure is to use OCT in conjunction with a catheter or probe 120, as shown generally in Figures 1A-2.

[0098] FIG. 2 illustrates an embodiment of a catheter or probe 120 including a sheath 121, a coil 122, a protector 123, and an optical probe 124. As shown generally in FIGS. 1A-2, the catheter 120 is preferably connected to the PIU 110 to spin the coil 122 by pullback (e.g., at least one embodiment of the PIU 110 functions to spin the coil 122 by pullback). The coil 122 delivers torque from its proximal end to its distal end (e.g., via or by a rotational motor in the PIU 110). In one or more embodiments, the coil 122 is fixed with / to the optical probe 124 so that the distal end of the optical probe 124 also spins to obtain an omnidirectional view of the biological organ, sample, target, or material being evaluated (e.g., a hollow organ such as a blood vessel, heart, lung, etc.). For example, fiber optic catheters and endoscopes may reside within the sample arm of an OCT interferometer (such as sample arm 103 shown in FIGS. 12A-12C ) to provide access to difficult-to-access internal organs (which may be viewed using one or more imaging modalities, such as intravascular imaging), the digestive tract, or other confined areas. A beam of light passing through an optical probe 124 within the catheter 120 or endoscope rotates across a surface of interest, resulting in cross-sectional images of one or more targets, objects, or samples. To acquire three-dimensional data, the optical probe 124 is simultaneously translated longitudinally during a rotational spin, resulting in a helical scan pattern. This translation can be accomplished by pulling the tip of the probe 124 back toward the proximal end, hence the term pullback. In one or more embodiments, the catheter 140 (e.g., shown in FIG. 8B ) may have the same or similar structure as the catheter 120, as desired.

[0099] In one or more embodiments, one or more components (such as one or more components of a probe (e.g., catheter 120 (see, e.g., FIGS. 1B-2, 12A-12C)), needle, capsule, patient interface unit or component (e.g., patient interface unit or component 110)) may be coupled to one or more other components (e.g., optics, a light source (e.g., light source 101), a deflection component (e.g., a deflection or The patient user interface 110 may comprise or include a connection component (or interface module), such as a rotary joint, for connecting to the deflected portion; the deflecting or deflected portion including at least one of an interferometer, a circulator, a beam splitter, an isolator, a coupler, a fused fiber coupler, a partially cut mirror with a hole, and a partially cut mirror with a tap; the splitter 104; the deflecting or deflected portion 108; etc.), the sample arm 102, the connecting components, and / or the patient user interface or patient interface unit 110 (a motor operative to power the patient user interface or patient interface unit 110, the motor M of the rotating device 70, the rotating device 70, etc.). For example, if the connecting component or interface module is a rotary joint, the rotary joint preferably functions as described below. In one or more other embodiments, the rotary joint may be at least one of a contact rotary joint, a lensless rotary joint, a lens-based rotary joint, or other rotary joint known to those skilled in the art. In one or more embodiments, the interferometer or optical interference system may include one or more components of system 100 (or other systems described herein) (e.g., one or more of light source 101, deflected portion 108, rotary junction RJ, PIU 110, catheter 120, etc.).One or more features of at least any of the configurations of FIGS. 1A-15 (and / or other configurations described herein) may be incorporated into one or more of the systems (e.g., system 10, device or system 20, systems 100, 100′, 100″, or other systems described herein).

[0100] In at least one embodiment, the PIU 110 may include a fiber optic rotary junction (FORJ), a rotation motor and translation motorized stage (e.g., part of the PIU 110), and a catheter connector (e.g., part of the PIU 110). The FORJ allows for uninterrupted transmission of optical signals while rotating the fiber along the fiber axis. The FORJ may include a free-space optical beam combiner including a rotor and a stator.

[0101] The descriptions of like-numbered elements (system 100, system 2, system 20, etc.) present in system 100' and already described above will not be repeated and are incorporated herein by reference in their entirety.

[0102] In at least one embodiment, the console / processor / computer 1200, 1200′ (or other processors described herein) is operable to control the movement of the motors and translation motorized stages (hereinafter referred to as “motors” or “motors and stages”), acquire intensity data from at least one detector 107, and display the scanned image (e.g., on a monitor or screen, such as a display, or on a screen or monitor 1209 shown in the console 1200 of FIG. 14 and / or the console 1200′ of FIG. 15 , as described below). In one or more embodiments, the console 1200, 1200′ is operable to change the speed of the motors and / or stop the motors. In at least one embodiment, the console or computer 1200, 1200′, or other computers or processors described herein, is further operable to control the movement of the RJ via the motion control unit (MCU) 112 or the motor M. In one or more embodiments, the MCU 112 or the motor M is operable to change the RJ motor and / or the speed of the RJ. The motor may be a stepper motor or a DC servo motor to control speed and increase position accuracy (e.g., compared to using no motor, compared to using an automated or controlled speed and / or position changing device, compared to manual control, etc.). In one or more embodiments, if a rotating device 70 having a separate motor M is used as described above, the console or computer 1200, 1200′, other computer or processor described herein, etc., further functions to control the motor M of the rotating device 70.

[0103] In one or more embodiments, console or computer 1200, 1200′ functions to control system 100 (and other systems, such as system 10, system 20, system 100′, system 100″, other devices or systems described herein, etc.), catheter 120, and / or one or more other previously described components of system 100 (or components of other systems described herein). In at least one embodiment, console or computer 1200, 1200′ receives signals from one or more detectors 107 of any system / device / apparatus described herein. It functions to acquire intensity data and display an image (e.g., on a monitor or screen such as display, screen, or monitor 1209 shown in console 1200 of FIG. 14 and / or console 1200' of FIG. 15, described below). The output of one or more components of system 100 (and other systems, such as system 10, system 20, system 100', system 100", or any other system described herein) is acquired by one or more detectors 107 of the system / instrument / device (e.g., photodiodes, photomultiplier tubes (PMTs), line scan cameras, or multi-array cameras, etc.). Electrical analog signals obtained from the output of system 100 (and / or other systems, such as system 10, system 20 (or a subsystem or system thereof), system 100′, system 100″, or any other system or device described herein), or one or more components thereof, are converted to digital signals and analyzed by a computer (e.g., computer 1200, 1200′, 2, image processor 50, or any other processor described herein (e.g., as shown in at least FIGS. 1A-1B, 5A, 8B, 12A-12C, 14-15)). In one or more embodiments, light source 101 may be a radioactive source or a broadband light source emitting light over a wide range of wavelengths. In one or more embodiments, a Fourier analyzer, including software and electronics, may be used to convert the electrical analog signals into an optical spectrum. In some embodiments, one or more detectors 107 include three detectors configured to detect light in three different bands.The output of the interferometer (e.g., an OCT interferometer, an interferometer of another imaging modality, etc.) can be detected by a first detector 107 (which can be a photodiode or a multi-array camera (or other type of detector described herein or known to those skilled in the art)) and then recorded by a computer (e.g., computer 1200 shown in Figures 1A-1B, 5A, 8B, 12A-12C, computer 1200 shown in Figure 14, computer 1200' shown in Figure 15, or other computers or processors described herein (e.g., at least image processor 50 shown in Figure 1B)).

[0104] Additionally or alternatively, the one or more detectors 107 may be a linear array, a charge-coupled device (CCD), multiple photodiodes, or some other method of converting light to an electrical signal. The one or more detectors 107 may transmit digital or analog signals to a processor or computer (such as an image processor, processor or computer 1200, 1200′ (see, e.g., FIGS. 1A-1B, 5A, 8B, 12A-12C, 14-15), other processors or computers described herein, or combinations thereof). The image processor may be a dedicated image processor or a general-purpose processor configured to process images. In at least one embodiment, the computer 1200, 1200′, or other processors or computers described herein may be used instead of or in addition to the image processor. In an alternative embodiment, the image processor may include an ADC and receive analog signals from the one or more detectors 107. The detector 107, in one or more embodiments, may include an analog-to-digital converter (ADC). The image processor may include one or more of a CPU, DSP, FPGA, ASIC, or some other processing circuit. The image processor may include memory for storing images, data, and instructions. The image processor may generate one or more images based on information provided by one or more detectors 107. A computer or processor described herein (such as the processor, computer 1200, computer 1200', image processor of the devices, apparatus, or systems of FIGS. 1-15) may include one or more components further described herein (see, e.g., FIGS. 14-15).

[0105] In one or more embodiments, one or more imaging techniques may be used, such as various OCT imaging techniques, lumen edge detection, stent strut detection, and / or artifact detection techniques, including at least other techniques described in U.S. Patent Application No. 62 / 901,472 (incorporated herein by reference in its entirety) and U.S. Patent Application No. 16 / 990,800 (filed August 11, 2020, and incorporated herein by reference in its entirety). In one or more embodiments of the present disclosure, an OCT image is formed in a polar coordinate system from A-lines. Each A-line contains significant information about the imaged object, such as clear indications of artifacts from metal objects (e.g., stents, stent struts, guidewires, PIU reflections, catheter / probe reflections, noise artifacts, etc.), such as narrow signal widths and / or sharp rising and falling edges; significant differences in signal intensity and shape of unobstructed soft tissue compared to sheath reflections and other artifacts, such as wide signal widths and gradual falling edges. Each A-line can represent a cross-sectional 1D sampling of a target, sample, object, etc., such as a blood vessel, along a particular field of view angle. As the imaging probe or instrument rotates (e.g., from about 0 degrees to about 360 degrees, from about 180 degrees to about 360 degrees, about 360 degrees, etc.), the corresponding A-lines form a complete two-dimensional (2D) cross-section of the target, sample, object, etc. (e.g., blood vessel) in polar coordinates, which are then transformed to Cartesian coordinates to form a tomographic view (TomoView) image of the cross-section of the target, sample, object, etc. (e.g., blood vessel).

[0106] In accordance with at least one aspect of the present disclosure, as previously noted, one or more additional methods for lumen, stent, and / or artifact detection in OCT images can be used in conjunction with one or more embodiments of the devices, systems, methods, and / or storage media described herein (e.g., techniques such as those described in U.S. Patent Application No. 16 / 414,222, filed May 16, 2019, the entire disclosure of which is incorporated herein by reference in its entirety, and U.S. Patent Publication No. 2019 / 0374109, published December 12, 2019, the disclosure of which is incorporated herein by reference in its entirety).

[0107] Regardless of the approach, in one or more embodiments, a predetermined or determined threshold can be used to detect the most significant pulse in a particular A-line that may correspond to a lumen edge (in one or more embodiments, the most significant pulse indicates the largest peak and its associated front edge, also referred to as the "main peak / edge"; such data may encompass or include artifact edge pixels). Any pulse that exceeds the threshold is an edge pulse of the object candidate. The pulse that is largest among all candidates in terms of area under the pulse is considered to be the largest peak (also referred to herein as the "most significant pulse" or "main peak / edge", etc.).

[0108] One or more embodiments of the present disclosure may be used in conjunction with one or more devices, systems, methods and / or storage media for performing engagement and / or disengagement status determination and / or engagement and / or disengagement guidance techniques, such as those described in U.S. Patent Publication No. 2022 / 0042783 (published February 10, 2022, the disclosure of which is incorporated herein by reference in its entirety).

[0109] As at least one example, the values ​​(e.g., angio delay (or delay time), peak value, median or central value, or other value stored for use by the device or system) can be stored in memory (e.g., non-volatile memory or other types of memory described herein) of the device or system (e.g., the patient interface unit PIU110, or other component or location of the device or system). As another example, the values ​​can be stored on a solid-state drive (SSD), a storage drive (e.g., a hard drive (HD), a hybrid hard drive (HHD), a solid-state hybrid drive (SSHD), etc.), other storage drive described herein, or other types of storage drive known to those skilled in the art (e.g., those described below).

[0110] In one or more embodiments, missing portions of the lumen edge can be interpolated to fill in missing data, as described in U.S. Patent Application No. 62 / 944,064 (filed December 5, 2019, the disclosure of which is incorporated herein by reference in its entirety) and U.S. Patent Application No. 17 / 098,042 (filed November 13, 2020, the disclosure of which is incorporated herein by reference in its entirety). For example, for each identified stent position, linear interpolation can be used to fill in gaps between or within the lumen edges. In one or more embodiments, both lumen peak and edge information are retained and interpolated. After processing, the entire lumen circle can be processed to form a closed lumen edge curve.

[0111] In one or more embodiments of buried stent detection, such as those described in U.S. Patent Application No. 62 / 944,064 (filed December 5, 2019, the disclosures of which are incorporated herein by reference in their entirety) and U.S. Patent Application No. 17 / 098,042 (filed November 13, 2020, the disclosures of which are incorporated herein by reference in their entirety), the peak curves may be similar, and the peak curves may be used to calculate a shadow accumulation profile or shadow profile for the entire image. In one or more embodiments, finding the center of the buried stent and / or stent struts may be based on a lumen peak curve or other methods or techniques, such as those described in U.S. Patent Application No. 62 / 944,064 (filed December 5, 2019, the disclosures of which are incorporated herein by reference in their entirety) and U.S. Patent Application No. 17 / 098,042 (filed November 13, 2020, the disclosures of which are incorporated herein by reference in their entirety). For example, in one or more embodiments of buried stent detection, stent peaks and / or edges behind lumen edges can be found, peak widths and / or thicknesses can be calculated, stent regions can be merged and expanded, buried stents can be confirmed and extracted, and strut position information can be determined / identified. Following the above steps, for example, to identify and confirm stent struts, valid buried stents can be extracted and confirmed, and their position information (such as strut center locations) can also be identified.

[0112] In one or more embodiments, the lumen edge may be output and / or the stent strut center position (and / or other stent strut position information) may be output, for example, as described in U.S. Patent Application No. 62 / 944,064 (filed December 5, 2019, the disclosure of which is incorporated herein by reference in its entirety) and U.S. Patent Application No. 17 / 098,042 (filed November 13, 2020, the disclosure of which is incorporated herein by reference in its entirety). A 1D smoothing filter may be applied or used to the lumen edge results. The lumen edge and / or stent strut center position information (and / or other stent strut position information) may be output in a desired format, stored in memory, printed, or displayed on a display, for example.

[0113] Using at least one device or system according to one or more aspects of the present disclosure and / or angio delay and / or synchronization techniques, polar coordinate OCT images (e.g., of blood vessels or other objects or targets) can be displayed vertically (rather than or in addition to horizontally) and / or together with corresponding Cartesian coordinate OCT images, as described in U.S. Patent Application No. 62 / 944,064 (filed December 5, 2019, the disclosure of which is incorporated herein by reference in its entirety) and U.S. Patent Application No. 17 / 098,042 (filed November 13, 2020, the disclosure of which is incorporated herein by reference in its entirety).

[0114] In one or more method embodiments, the lumen edge can be converted to Cartesian coordinates, as described in U.S. Patent Application No. 16 / 414,222 (filed May 16, 2019, the entire disclosure of which is incorporated herein by reference in its entirety) and U.S. Patent Publication No. 2019 / 0374109 (published December 12, 2019, the disclosure of which is incorporated herein by reference in its entirety).

[0115] A computer (such as console or computer 1200, 1200′, image processor 50, console or computer 2, or any other processor or computer described herein) may perform any of the steps, processes, and / or techniques described herein for any device and / or system (such as device or system 10, device or system 20, device or system 100, device or system 100′, device or system 100″, or any other device or system described herein) in manufacture or use.

[0116] In accordance with one or more further aspects of the present disclosure, a benchtop system can be utilized with one or more imaging modalities (e.g., angiography, optical coherence tomography (OCT), multi-modality OCT (MM-OCT), near-infrared autofluorescence (NIRAF), near-infrared fluorescence (NIRF), OCT-NIRAF, OCT-NIRF, etc.) for techniques such as the imaging techniques, angio-delay (or time delay) determination techniques, and / or synchronization techniques described herein.

[0117] 12A illustrates an OCT system 100 (herein referred to as "system 100") according to one or more embodiments of the present disclosure, which may be used for one or more imaging modalities and may be used in conjunction with angio-delay (or delay time) determination and / or synchronization techniques. System 100 includes a light source 101, a reference arm 102, a sample arm 103, a deflected or deflecting portion 108, a reference mirror (also referred to as a "reference reflection," "reference reflector," "partial reflection mirror," and "partial reflector") 105, and one or more detectors 107 (which may be connected to a computer 1200 or other computers or processors described herein). In one or more embodiments, system 100 may include a patient interface device or unit (“PIU”) 110 and a catheter 120 (see, e.g., examples of PIUs and catheters shown in FIGS. 1B, 2, 5A, and / or 12A-12C), and system 100 may interact with (e.g., via catheter 120 and / or PIU 110) an object 106, a patient (e.g., a patient's blood vessels) 106, etc. In one or more embodiments, system 100 includes an interferometer or an interferometer defined by one or more components of system 100, such as at least light source 101, reference arm 102, sample arm 103, deflection unit 108, and reference mirror 105.

[0118] According to one or more further aspects of the present disclosure, benchtop systems can be utilized with one or more imaging modalities and can be used in conjunction with the angio delay (or delay time) determination and / or synchronization features described herein. FIG. 12B illustrates an example of a system for benchtop applications, such as ophthalmology, that can utilize one or more imaging modalities and associated methods described herein. Light from a light source 101 is delivered and split by a deflector 108 into a reference arm 102 and a sample arm 103. In the reference arm 102, the reference beam passes through a length adjuster 904 and is reflected from a reference mirror (such as the reference mirror or reference reflection 105 shown in FIG. 12A or similar), while in the sample arm 103, the sample beam is reflected or scattered (e.g., via a PIU 110 and a catheter 120) from an object, patient (e.g., a patient's blood vessels), etc. 106. In one embodiment, both beams combine at the deflector 108 to generate interference fringes. In one or more embodiments, the beams travel to combiner 903, which combines the beams via circulator 901 and deflector 108, and sends the combined beam to one or more detectors (such as one or more detectors 107). The interferometer outputs are continuously acquired by one or more detectors, such as one or more detectors 107. The electrical analog signals are converted to digital signals and analyzed by a computer (such as computer 1200 (see FIGS. 12A-12C; also shown in FIG. 14, further described below), computer 1200′ (see, e.g., FIG. 15, further described below), computer 2 (see FIG. 1A), image processor 50 (see FIG. 1B), or any other computer or processor described herein). Additionally or alternatively, one or more of the computers, CPUs, processors, etc. described herein can be used to process, control, update, enhance, and / or modify one or more of the imaging modalities and / or related techniques, functions, or methods, or to process the electrical signals as described above.

[0119] The electrical analog signals may be converted to digital signals and analyzed by a computer (such as computer 1200 (see FIGS. 1B and 12A-12C; also shown in FIG. 14, further described below), computer 1200′ (see, e.g., FIG. 15, further described below), computer 2 (see FIG. 1A), image processor 50 (see FIG. 1B), or any other computer or processor described herein). Additionally or alternatively, one or more of the computers, CPUs, processors, etc. described herein may be used to process, control, update, enhance, and / or modify one or more imaging modalities and / or related techniques, functions, or methods, or may process the electrical signals as previously described. In one or more embodiments (see, e.g., FIG. 12B), sample arm 103 includes PIU 110 and catheter 120 such that the sample beam is reflected or scattered from an object, patient (e.g., the patient's blood vessels), etc. 106, as described herein. In one or more embodiments, the PIU 110 may include one or more motors (see, e.g., motor M in FIG. 1B ) to control the pullback motion of the catheter 120 (or one or more components thereof) and / or to control the rotation or spin of the catheter 120 (or one or more components thereof). For example, as best seen in FIG. 12B , the PIU 110 may include a pullback motor (PM) and a spin motor (SM) and / or a motion control unit 112 operative to perform the pullback and / or rotation functions using the pullback motor PM and / or the spin motor SM. As discussed herein, the PIU 110 may include a rotary joint (e.g., rotary joint RJ as shown in FIGS. 12B and 12C ). The rotary joint RJ may be connected to the spin motor SM to enable the catheter 120 to acquire one or more views or images of an object, patient, etc. 106 (e.g., the patient's blood vessels).Computer 1200 (e.g., computer 1200′, computer 2, image processor 50, or other computers or processors described herein) can be used to control one or more of pullback motor PM, spin motor SM, and / or motion control unit 112 (and / or one or more processors described herein can control motor M of rotating device 70, as previously described). The OCT system can include, for example, one or more of a computer (e.g., computer 1200, computer 1200′, computer 2, image processor 50, or other computers or processors described herein), PIU 110, catheter 120, and monitor (e.g., display 1209). One or more embodiments of an imaging (e.g., OCT, IVUS, MM-OCT, intravascular, an imaging modality described herein, or an imaging modality known to those skilled in the art) device or system can interact with one or more external systems, such as an angio system, an external display, one or more hospital networks, an external storage medium, a power source, a bedside controller (which can be connected to the OCT system using, for example, Bluetooth® technology or other methods known for wireless communication).

[0120] In one or more embodiments including a deflecting or deflected portion 108 (best seen in Figures 12A-12C), the deflected portion 108 can function to deflect light from the light source 101 into the reference arm 102 and / or the sample arm 103, and then direct light received from the reference arm 102 and / or the sample arm 103 towards at least one detector 107 (e.g., a spectrometer, one or more components of a spectrometer, another type of detector, etc.). In one or more embodiments, the deflected portion (e.g., deflected portion 108 of systems 100, 100′, 100″, and other systems described herein) may include or comprise one or more interferometers or optical interference systems (e.g., circulators, beam splitters, isolators, couplers (e.g., fused fiber couplers), partially cut mirrors with holes, partially cut mirrors with taps, and the like) that function as described herein. In one or more embodiments, the interferometers or optical interference systems may include one or more components of system 100 (or other systems described herein) (e.g., one or more of light source 101, deflected portion 108, rotary junction RJ, PIU 110, catheter 120, and the like). One or more features (or any combination of such features) of at least the configurations of FIGS. 1A-15 described herein may be incorporated into one or more of systems 10, 20, 100, 100′, 100″, and the like described herein.

[0121] According to one or more further aspects of the present disclosure, one or more other systems can be used in conjunction with one or more of the one or more imaging modalities and related methods, and can be used in conjunction with the angio-delay (or delay time) determination and / or synchronization features as disclosed herein. FIG. 12C illustrates an example of a system 100″ that can utilize one or more imaging modalities and / or related techniques or methods, and can be used in conjunction with the angio-delay (or delay time) determination and / or synchronization features, for example, for ophthalmology applications. FIG. 12C illustrates an exemplary schematic diagram of an OCT-fluorescence imaging system 100″, according to one or more embodiments of the present disclosure. An OCT light source 101 (e.g., at 1.3 μm) is delivered to and split by a deflector or deflected element (e.g., a splitter) 108 into a reference arm 102 and a sample arm 103 to generate a reference beam and a sample beam, respectively. The reference beam from the OCT light source 101 is reflected by the reference mirror 105, and the sample beam is reflected or scattered from the object (e.g., object under examination, object, patient, etc.) 106 via the circulator 901, the rotary junction ("RJ"), and the catheter 120. In one or more embodiments, the fiber between the circulator 901 and the reference mirror or reference reflection 105 can be coiled to adjust the length of the reference arm 102 (best seen in FIG. 12C). The optical fiber in the sample arm 103 can be comprised of a double-clad fiber ("DCF"). Excitation light for fluorescence can be directed through the RJ and the catheter 120 to illuminate the object (e.g., object under examination, object, patient, etc.) 106. Light from the OCT light source 101 can be delivered through the core of the DCF, while fluorescent light emitted from the object (e.g., object under examination, object, patient, etc.) 106 can be collected through the cladding of the DCF. In pullback imaging, the RJ can be moved with the linear stage to achieve a helical scan of the object (e.g., an object under examination, an object, a patient, etc.) 106. In one or more embodiments, the RJ can include any one or more features of a rotary joint as described herein. Dichroic filters DF1 and DF2 can be used to separate the OCT light from the excitation light and residual fluorescence.For example, but not by way of limitation, in one or more embodiments, DF1 may be a long-pass dichroic filter with a cutoff wavelength of approximately 1000 nm, allowing OCT light (which may be longer than the cutoff wavelength of DF1) to pass through DF1 while fluorescence excitation and emission (which are at wavelengths shorter than the cutoff) are reflected by DF1. In one or more embodiments, for example, but not by way of limitation, DF2 may be a short-pass dichroic filter. The excitation wavelength may be shorter than the fluorescence emission light such that excitation light (which has a wavelength shorter than the cutoff wavelength of DF2) can pass through DF2 while the fluorescence emission light is reflected by DF2. In one embodiment, both beams are combined at deflection unit 108 to generate interference fringes. In one or more embodiments, the beams travel to a coupler or combiner 903, which combines both beams via a circulator 901 and a deflector 108, and the combined beam is sent to one or more detectors (such as one or more detectors 107; see, for example, the first detector 107 connected to the coupler or combiner 903 in FIG. 12C).

[0122] In one or more embodiments, the optical fiber within the catheter 120 may be operated to rotate inside the catheter 120, and the OCT light and excitation light may be emitted from a side angle at the tip of the catheter 120. After interacting with the object or patient 106, the OCT light may be returned to the OCT interferometer (e.g., via a circulator 901 in the sample arm 103), which may include a coupler or combiner 903, and combined with a reference beam (e.g., via a coupler or combiner 903) to generate interference fringes. The output of the interferometer may be detected by a first detector 107 (which may consist of or include a photodiode or a multi-array camera) and then recorded via a first data acquisition unit or board ("DAQ1") in a computer (e.g., computer 2, computer 1200 shown in FIG. 12C, computer 1200', or other computers described herein).

[0123] Simultaneously, or at different times, the fluorescence intensity can be recorded via a second detector 107 (e.g., a photomultiplier tube) through a second data acquisition unit or board ("DAQ2"). The OCT and fluorescence signals can then be processed by a computer (e.g., computer 2, computer 1200 shown in FIG. 12C, computer 1200', or other computers described herein) to generate an OCT-fluorescence data set 140 (which can include or consist of multiple frames of helical scan data). Each set of frames can include or consist of multiple data elements of co-registered OCT and fluorescence data corresponding to a rotation angle and pullback position.

[0124] The detected fluorescent or autofluorescent signals can be processed or further processed as discussed in U.S. Patent Application No. 62 / 861,888 (filed June 14, 2019, the disclosure of which is incorporated by reference herein in its entirety) and / or U.S. Patent Application No. 16 / 368,510 (filed March 28, 2019, published October 3, 2019 as U.S. Patent Publication No. 2019 / 0298174, the disclosure of which is incorporated by reference herein in its entirety).

[0125] Without being limited to such arrangements, configurations, devices, or systems, one or more embodiments of the devices, apparatus, systems, methods, storage media, GUIs, etc. described herein can be used in conjunction with such devices or systems (e.g., system 100, system 100′, system 100″, the devices, devices, or systems of FIGS. 1A-15, other devices, devices, or systems described herein, etc.). In one or more embodiments, a single user can perform the methods described herein. In one or more embodiments, one or more users can perform the methods described herein. In one or more embodiments, one or more of the computers, CPUs, processors, etc. described herein can be used to process, control, update, enhance, and / or modify one or more of the imaging modalities and / or process related techniques, functions, or methods, or can process electrical signals as described above.

[0126] There are many ways, both digital and analog, to calculate the rotation, intensity, and other measurements described herein and / or to control and / or manufacture the devices / apparatus, systems, and / or storage media. In at least one embodiment, a computer, such as console or computer 1200, 1200′ (or other processors or computers described herein), may be dedicated to controlling and / or using the devices, systems, methods, and / or storage media used therewith. In one or more embodiments, the devices / apparatus, systems, methods, and / or storage media may be for MM-OCT or OCT (or other imaging modalities described herein or known to those skilled in the art).

[0127] Unless otherwise noted herein, like numbers refer to like elements. For example, while variations or differences exist between systems / apparatuses (e.g., system 10, system 20, system 100, system 100', system 100", and other systems / apparatuses described herein), one or more features thereof may be the same or similar to each other (e.g., light source 101, deflection unit 108, and other components thereof (e.g., console / computer / processor 1200, console / computer / processor 1200', etc.)). One skilled in the art will appreciate that light source 101, at least one detector 107, and / or one or more other elements of system 100 may function in the same or similar manner as like-numbered elements of one or more other systems (e.g., system 10, system 20, system 100', system 100", and other devices or systems described herein). Those skilled in the art will appreciate that alternative embodiments of system 10, system 20, system 100, system 100', system 100", or any other device or system described herein, and / or one or more like-numbered elements of one of such systems, may function in the same or similar manner as the like-numbered elements of any of the other systems (or components thereof) described herein, although including other variations as discussed herein. Indeed, while certain differences exist between system 10, system 20, system 100, system 100', system 100, etc. described herein, there are similarities between the devices / systems described herein. Similarly, while console or computer 1200 may be used in one or more systems (e.g., system 20, system 100, system 100', system 100", or any other device / system described herein), one or more other consoles or computers (console or computer 1200', console or computer 2, image processor 50, or any other processor or computer described herein) may additionally or alternatively be used.

[0128] According to one or more aspects of the present disclosure, one or more methods for detecting and guiding optical coupling are provided herein, and one or more methods for performing imaging are provided. FIG. 13 shows a flowchart of at least one embodiment of a method for performing imaging. Preferably, the method may include one or more of the following: (i) splitting light into a first light and a second reference light (see step S4000 of FIG. 13 ); (ii) receiving reflected or scattered light of the first light after the first light travels along a sample arm and illuminates an object or sample (see step S4001 of FIG. 13 ); (iii) receiving the second reference light after the second reference light travels along a reference arm and reflects off a reference reflection (see step S4002 of FIG. 13 ); and (iv) interfering the reflected or scattered light of the first light and the reflected second reference light with each other (e.g., by combining or recombining and then interfering, by interfering, etc.) to generate interference light that produces one or more interference fringes (see step S4003 of FIG. 13 ). One or more methods may further include using a low frequency monitor to update or control the high frequency content to improve image quality. For example, one or more embodiments may achieve improved image quality using balanced detection, polarization diversity, automatic polarization control, etc. In one or more embodiments, the imaging probe may be connected to one or more systems (e.g., system 10, system 20, system 100, system 100′, system 100″, rotating device 70, or other systems or devices described herein) by a connecting member or interface module. For example, if the connecting member or interface module is a rotary junction (or rotary joint) of the imaging probe, the rotary junction may be at least one of a contact rotary junction, a lensless rotary junction, a lens-based rotary junction, or other rotary junction known to those skilled in the art. The rotary junction may be a one-channel rotary junction or a two-channel rotary junction. In one or more embodiments, the illumination section of the imaging probe may be separate from the detection section of the imaging probe.For example, in one or more applications, a probe may refer to an illumination assembly including an illumination fiber (e.g., a single-mode fiber, a GRIN lens, a spacer, a diffraction grating on the polished surface of the spacer, etc.). In one or more embodiments, a scope may refer to an illumination section that may be surrounded and protected by, for example, a drive cable, a sheath, and a detection fiber (e.g., a multimode fiber (MMF)) around the sheath. Grating coverage is optional for the detection fiber (e.g., MMF) for one or more applications. The illumination section may be connected to a rotary joint and may rotate continuously at video rates. In one or more embodiments, a detection section may include one or more of a detection fiber, a detector (e.g., one or more detectors 107, a spectrometer, etc.), computer 1200, computer 1200′, other computers or processors described herein, etc. The detection fiber may surround the illumination fiber, and the detection fiber may or may not be covered by a diffraction grating, a spacer, a lens, the end of the probe or catheter, etc.

[0129] There are many ways, both digital and analog, to calculate power and / or perform one or more of the techniques described herein (e.g., angio delay (or delay time) determination and / or synchronization features and techniques). In at least one embodiment, a console or computer, such as computer 1200, 1200', may be dedicated to controlling and monitoring the devices, systems, methods and / or storage media for imaging described herein (e.g., intravascular, OCT, MM-OCT, other imaging modalities described herein, or known to those skilled in the art).

[0130] The electrical signals used for imaging can be transmitted via cables or wires, such as cable or wire 113 (see FIG. 14), to one or more processors (e.g., computer 1200 (see, e.g., FIGS. 1B, 5A, 8B, 12A-12C, and 14), computer 1200′ (see, e.g., FIG. 15), computer 2 (see, e.g., FIG. 1A), image processor 50 (see, e.g., FIG. 1B), etc.) as described below. Computer or processor 1200, 1200′ can be used in place of other computers or processors described herein (e.g., processor 1200 can be used in place of processor 1200′, processor 1200′ can be used in place of processor 2, processors 1200, 1200′ can be used together, any processor described herein can be used alone, any processor described herein can be used in conjunction with other processors described herein, etc.). Processor 2, image processor 50, or other processors described herein may have the same or similar structure as processor 1200 shown in FIG. 14 or processor 1200' shown in FIG. 15. In other words, the computers and processors described herein are interchangeable and may function to perform one or more of the imaging modality features and methods, or any of the other techniques and methods described herein, such as the angio delay (or delay time) determination and / or synchronization features and techniques. The communication interface of computer 1200 may be connected to other components described herein via wiring 113 (as shown diagrammatically in FIG. 12).

[0131] 14 provides various components of a computer system 1200 (see, for example, the console or computer 1200 shown in FIGS. 1B, 5A, 8B, and 12A-12C). The computer system 1200 may include a central processing unit ("CPU") 1201, ROM 1202, RAM 1203, a communication interface 1205, a hard disk (and / or other storage device) 1204, a screen (or monitor interface) 1209, a keyboard (or input interface; which may include a mouse or other input device in addition to a keyboard) 1210, and a BUS or other connection (e.g., connection 1213) between one or more of the aforementioned components (e.g., as shown in FIG. 14). In addition, the computer system 1200 may include one or more of the aforementioned components. For example, computer system 1200 may include a CPU 1201, RAM 1203, an input / output (I / O) interface (such as communication interface 1205), and a bus (which may include one or more wirings 1213 as a communication system between components of computer system 1200; in one or more embodiments, computer system 1200 and at least its CPU 201 may communicate with one or more of the aforementioned components of a FORJ or an apparatus or system using the FORJ (such as system 100, system 100', system 100", and / or other apparatus or systems described herein) via one or more wirings 1213), and one or more other computers or systems. System 1200 may include one or more combinations of the other aforementioned components. CPU 1201 is configured to read and execute computer-executable instructions stored on a storage medium. The computer-executable instructions may include instructions for performing the methods and / or calculations described herein. Computer system 1200 may include one or more additional processors in addition to CPU 1201, which processors, including CPU 1201, may be used to control and / or manufacture devices, systems, or storage media used in conjunction with it or with any of the imaging techniques and / or angio delay (or delay time) determination and / or synchronization features and techniques described herein.System 1200 may further include one or more processors connected via a network connection (e.g., via network 1206). CPU 1201 and any additional processors used by system 1200 may be located within the same telecommunications network or may be located in different telecommunications networks (e.g., the execution, manufacture, control, and / or use of the technology may be remotely controlled).

[0132] The I / O interface or communication interface 1205 provides a communication interface to input / output devices (which may include light source 101, RJ, PM, SM, unit 150, unit 112, rotating equipment 70, microphone, communication cables and networks (wired or wireless), keyboard 1210, mouse (see, for example, mouse 1211 shown in FIG. 15), touch screen or screen 1209, light pen, etc. The monitor interface or screen 1209 provides a communication interface thereto.

[0133] Any of the methods and / or data of the present disclosure (including methods of using and / or manufacturing an apparatus, system, or storage medium used therewith, and / or methods of imaging described herein, and / or methods of angio delay (or delay time) determination and / or synchronization features or techniques described herein) can be stored on a computer-readable storage medium. A commonly used computer-readable and / or writable storage medium may be used to cause a processor (such as the processor or CPU 1201 of the computer system 1200 described above) to perform the steps of one or more methods disclosed herein (e.g., one or more of a hard disk (e.g., hard disk 1204, magnetic disk, etc.), flash memory, CD, optical disk (e.g., compact disk ("CD"), digital versatile disk ("DVD"), Blu-ray™ disk, etc.), magneto-optical disk, random access memory ("RAM") (e.g., RAM 1203), DRAM, read-only memory ("ROM"), distributed computer system storage, memory card or the like (e.g., non-volatile memory card, solid-state drive (SSD) (see SSD 1207 in FIG. 15), other semiconductor memory such as SRAM), any combination thereof, server / database, etc.). The computer-readable storage medium may be a non-transitory computer-readable medium and / or may include all computer-readable media with the sole exception that they are transitory and propagate signals. A computer-readable storage medium may include a medium that stores information for a predetermined period of time, a limited period of time, or a short period of time, and / or only in the presence of power, such as random access memory (RAM), register memory, processor cache, etc.Embodiments of the present disclosure may be realized by a computer of a system or device that reads and executes computer-executable instructions (e.g., one or more programs) recorded on a storage medium (which may more fully be referred to as a "non-transitory computer-readable storage medium") to perform one or more functions of the aforementioned embodiments and / or includes one or more circuits (e.g., application specific integrated circuits (ASICs)) for performing one or more functions of the aforementioned embodiments, or may be realized by a method performed by a computer of a system or device that reads and executes computer-executable instructions from a storage medium to perform one or more functions of the aforementioned embodiments and / or controls one or more circuits to perform one or more functions of the aforementioned embodiments.

[0134] In accordance with at least one aspect of the present disclosure, the aforementioned methods, apparatus, systems, and computer-readable storage media associated with a processor (such as processor or computer 2, the processor of computer 1200 described above, the processor of computer 1200', image processor 50, or any other processor described herein) can be achieved using suitable hardware such as illustrated in the figures. The functionality of one or more aspects of the present disclosure can be achieved using suitable hardware such as that shown in FIG. 14. Such hardware can be implemented using known technology, such as standard digital circuits, any known processor operable to execute software and / or firmware programs, one or more programmable digital devices or systems (such as programmable read-only memories (PROMs), programmable array logic devices (PALs), etc.). CPU 1201 (shown in FIG. 14 or FIG. 15) may include and / or consist of one or more microprocessors, nanoprocessors, one or more graphics processing units ("GPUs," also known as visual processing units ("VPUs")), one or more field programmable gate arrays ("FPGAs"), or other types of processing components (e.g., application-specific integrated circuits (ASICs)). Furthermore, various aspects of the present disclosure may be implemented by software and / or programs, which may be stored on an appropriate storage medium (e.g., a computer-readable storage medium, hard drive, solid-state drive, hybrid hard drive, etc.) or a medium for transport and / or distribution (e.g., a floppy disk, memory chip, etc.). A computer may include a network of separate computers or separate processors for reading and executing computer-executable instructions. Computer-executable instructions may be provided to the computer, for example, from a network or a storage medium.A computer or processor (such as 2, 1200, 1200', 50, or any other computer or processor described herein) may include the CPU structures described above or may be coupled to such CPU structures for communication therewith.

[0135] As mentioned above, Figure 15 shows the hardware structure of an alternative embodiment of a computer or console 1200'. The computer 1200' includes a central processing unit (CPU) 1201, a graphics processing unit (GPU) 1215, random access memory (RAM) 1203, a network interface device 1212, an operating interface 1214 (such as a universal serial bus (USB)), and memory (such as a hard disk drive or solid state drive (SSD)) 1207. Preferably, the computer or console 1200' includes a display 1209. The computer 1200′ can be connected to a rotary junction (e.g., RJ in FIG. 12B , RJ in FIG. 12C , etc.), a motor PM, a motor SM, and / or one or more other components of a system (e.g., system 10, system 20, system 100, system 100′, system 100″, other systems / apparatuses described herein, etc.) via an operation interface 1214 or a network interface 1212. A computer such as computer 1200, 1200′, in one or more embodiments, may include an RJ, a PM, and / or an SM. The computer 1200′ can be connected to a rotary junction (e.g., RJ in FIG. 12B , RJ in FIG. 12C , etc.) via an operation interface 1214 or a network interface 1212 (e.g., via a cable or fiber such as cable or fiber 113 similar to that shown in FIG. 14 ), The CPU 1201 or GPU 1215 may be connected to a motor, console, or other component of an apparatus or system described herein. In one or more embodiments, a computer such as the computer 1200′ may include a motor or motion control unit (MCU). The operation interface 1214 is connected to an operation unit such as a mouse device 1211, a keyboard 1210, or a touch panel device. The computer 1200′ may include two or more of each component. Alternatively, the CPU 1201 or GPU 1215 may be replaced by a field programmable gate array (FPGA), an application specific integrated circuit (ASIC), or other processing unit, depending on the design of the computer (e.g., the computer 1200, the computer 1200′, or other computers or processors described herein).

[0136] The computer program is stored on the SSD 1207, and the CPU 1201 loads the program into the RAM 1203 and executes the program's instructions to perform one or more processes described herein, as well as basic input, output, calculation, memory write and memory read processes.

[0137] A computer (e.g., computer 1200, 1200′) communicates with the PIU 110, the rotary joint (e.g., RJ), the motor PM, the motor SM, the catheter 120, and / or one or more other components of the system (e.g., systems 10, 20, 100, 100′, 100″, etc.) to perform imaging and reconstruct images from acquired intensity data. A monitor or display 1209 displays the reconstructed image and may also display other information about the imaging conditions or the object being imaged. The monitor 1209 also provides a graphical user interface for a user to operate the device or system (e.g., system 10, system 20, system 100, system 100′, system 100″, other devices or systems described herein, etc.), for example, when performing OCT or other imaging techniques (e.g., angio delay (or delay time) determination and / or synchronization features or techniques, etc.). Operation signals are input from an operation unit (e.g., a mouse device 1211, a keyboard 1210, a touch panel device, etc.) to an operation interface 1214 of the computer 1200′, and in response to the operation signals, the computer 1200′ commands an apparatus or system (e.g., system 10, system 20, system 100, system 100′, system 100″, or other apparatus or system described herein) to set or change imaging conditions, start or end imaging, and / or start or end angio delay (or delay time) determination and / or synchronization features or techniques. The laser source 101 of the above OCT system may have an interface for communicating with the computer 1200, 1200′ to send and receive status information and control signals.

[0138] Without being limited to such arrangements, configurations, devices, or systems, one or more embodiments of the devices, apparatus, systems, methods, storage media, etc. described herein can be used in conjunction with such devices or systems (e.g., system 10, system 20, system 100, system 100′, system 100″, the devices, devices, or systems of FIGS. 1-15, other devices, devices, or systems described herein, etc.). In one or more embodiments, a single user can perform the methods described herein. In one or more embodiments, one or more users can perform the methods described herein. In one or more embodiments, one or more of the computers, CPUs, processors, etc. described herein can be used to process, control, update, enhance, and / or modify one or more of the imaging modalities and / or process related techniques, functions, or methods, or can process electrical signals as described above.

[0139] Furthermore, unless otherwise specified, the term "subset" of a corresponding set does not necessarily refer to a subset in the strict sense, but may be equivalent to the corresponding set.

[0140] One or more components of the present disclosure and / or its devices, systems, and storage media and / or methods may also be used in conjunction with optical coherence tomography probes, including OCT imaging systems such as those disclosed in U.S. Patent Nos. 6,763,261, 7,366,376, 7,843,572, 7,872,759, 8,289,522, 8,676,013, 8,928,889, 9,087,368, 9,557,154, 10,912,462, 9,795,301, and 9,332,942 to Tearney et al., and structures and methods for facilitating photoluminescence imaging, such as those disclosed in U.S. Patent No. 7,889,348 to Tearney et al. ) and disclosures directed to multi-modality imaging disclosed in U.S. Pat. No. 9,332,942; U.S. Patent Publication Nos. 2010 / 0092389, 2011 / 0292400, 2012 / 0101374, 2014 / 0276011, 2017 / 0135584, 2016 / 0228097, 2018 / 0045501, 2018 / 0003481, WO2016 / 015052 to Tearney et al., and WO2016 / 144878 (each of which patents, patent publications, and patent applications is incorporated herein by reference in its entirety). As previously noted, any feature or aspect of the present disclosure may be incorporated herein by reference in its entirety, as described in U.S. Patent Application No. 16 / 414,222 (filed May 16, 2019, the disclosure of which is incorporated herein by reference in its entirety), U.S. Patent Publication No. 2019 / 0374109 (published December 12, 2019, the disclosure of which is incorporated herein by reference in its entirety), U.S. Patent Application No. 62 / 944,064 (filed December 5, 2019, the disclosure of which is incorporated herein by reference in its entirety), or U.S. Patent Application No. 62 / 944,064 (filed December 5, 2019, the disclosure of which is incorporated herein by reference in its entirety). No. 2021 / 0077037 (published March 18, 2021), U.S. Patent Publication No. 2021 / 0174125 (published June 10, 2021), and U.S. Patent Application No. 17 / 098,042 (filed November 13, 2020, the disclosures of which are incorporated herein by reference in their entirety).

[0141] The present disclosure, and / or one or more components of the devices, systems and storage media, and / or methods thereof, may be used in OCT imaging systems and / or catheters and catheter systems (see U.S. Patent Nos. 9,869,828, 10,323,926, 10,558,001, 10,601,173, 10,606,064, 10,743,749, 10,884,199, 10,895,692, and 11,175,126, and U.S. Patent Publication Nos. 2019 / 0254506, 2020 / 0390323, 2021 / 0121132, 2021 / 0174125, 2022 / 0040454, 2022 / 0044428, and WO2021 / 055837 (each of which patents and patent publications is incorporated by reference in its entirety).

[0142] Although the disclosure herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure (and are not limited thereto). It is to be understood, therefore, that many modifications can be made to the illustrative embodiments and that other arrangements can be devised without departing from the spirit and scope of the present disclosure. The scope of the following claims should be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.

Claims

1. An image processing device, a catheter or probe including one or more markers or radiopaque markers, the catheter or probe being used when one or more angiographic images of an object are acquired by the image processing device and operable to acquire one or more intravascular images of the object; a rotating device having a stationary portion and a rotating portion, the stationary portion and the rotating portion each having a window or area, the window or area of ​​the rotating portion configured to overlap the window or area of ​​the stationary portion at one or more times during rotation of the rotating portion; one or more processors; Equipped with The one or more processors: acquiring the one or more angiographic images of the object; acquiring the one or more intravascular images at an acquisition location within at least a portion of the object, wherein the one or more angiographic images are acquired before, after, or simultaneously with the acquisition of the one or more intravascular images, the one or more angiographic images being acquired from a first data source and the one or more intravascular images being separately acquired from a second data source; estimating or determining a delay time by measuring a delay time, which is a difference in latency between the first data source and the second data source, using a synchronization signal; It functions to execute The one or more processors: (i) detecting, on or using said angio-frames, said frames containing partially or fully open windows or regions, and calculating said open windows or regions for each image frame; and / or (ii) further operable to calculate the delay time by: determining a peak time at which the calculated open window or area is maximum based on a signal represented by an amount of overlap between at least the open window or area of ​​the rotating device and one or more open areas in one or more angio images; determining or identifying a corresponding time value for a corresponding portion or location of the optical signal; and calculating the time between the peak time and the corresponding time value determined or identified for the corresponding portion or location of the optical signal. Device.

2. the optical signal is or includes one or more of excitation light, light operable to generate an OCT image, near-infrared fluorescence (NIRF), and near-infrared autofluorescence (NIRAF); The one or more processors: (i) further functioning to control the device and the catheter or probe using or for signal light or NIRF light and / or NIRAF light, or the modality of the NIRF light and / or NIRAF light, to be in a ready state, and / or to prepare the rotating portion of the rotating device to rotate for pullback; (ii) further operable to initiate the pullback, turn on the optical signal or a source of the optical signal, and trigger rotation of the rotating part of the rotating device to rotate one or more revolutions under an angio image view; and / or (iii) detecting the optical signal or the NIRF light and / or NIRAF light on or with the one or more intravascular images, and further operable to detect the frames in which the optical signal or the light source of the optical signal is on by finding a center, middle, or other predetermined portion of the optical signal or the NIRF light and / or NIRAF signal; 10. The apparatus of claim 1.

3. (i) the rotating portion and the stationary portion of the rotating device each have plates of the same size and / or shape, each plate having the window or area of ​​the same size and / or shape, or the rotating portion and the stationary portion of the rotating device each have plates of the same size and / or shape, each plate having the window or area of ​​the same size and / or shape, the shape being one of a triangle, a trapezoid, a square, a rectangle, and a circle; (ii) the stationary portion is fixed to a base or other location of the rotating device, and the rotating portion is operable to rotate about an axis on or adjacent to the stationary portion, whereby the rotating portion acts as a shutter, the shutter being open when the window or area of ​​the rotating portion and the stationary portion partially or completely overlaps, and the shutter being closed otherwise; (iii) the rotating instrument evaluates and confirms whether the windows or regions are partially or completely overlapping using X-rays that pass through or are blocked by the windows or regions detectable in the one or more angiographic images; (iv) the rotating device includes a switch and a light emitting diode (LED), the switch operative to connect both the rotating portion and the stationary portion when the window or area is at the peak time such that the switch turns on the LED during the peak time and turns off the LED at other times; 10. The apparatus of claim 1.

4. The one or more processors: (i) further operable to display or present the overlapped windows or areas from the closed position or state of the shutters to the maximum fully overlapped area of ​​the windows or areas at the peak time; (ii) further operable to measure a size of the window or region in each image frame of the one or more intravascular images and / or in each frame of the one or more angiographic images; (iii) if the peak time is between frames, further operable to interpolate the peak time using two adjacent frames to refine the location of the peak time; 4. The apparatus of claim 3.

5. The one or more processors: (i) displaying a graphical user interface (GUI) on a display, the GUI operable to manage angio delay time information for multiple operating rooms (ORs) or other locations such that the device is configured for use in different locations; (ii) performing an initialization process that serves to add or include data about all of the ORs or other locations in the device; (iii) performing the estimation or determination of the delay times for each of all of the ORs and other locations whose data has been added or included in the device to estimate or determine a respective delay time for each location, and / or recording the respective estimated or determined delay times for each location, so that one or more estimated or determined delay times are recorded, to enable angio delay compensation to be applied to all pullbacks performed at each of all of the ORs and other locations; The apparatus of claim 1 , further operative to perform:

6. The object includes a tube containing blood or a tube from which blood has been flushed.

10. The apparatus of claim 1.

7. The one or more processors: co-registering the one or more acquired angiographic images with the one or more acquired intravascular images; co-registering the one or more acquired angiographic images and the one or more intravascular images, wherein the one or more angiographic images and the one or more intravascular images are of a plurality of imaging modalities, the plurality of imaging modalities including one or more optical coherence tomography (OCT) images or frames or intravascular ultrasound (IVUS) images or frames, tomographic images, fluorescence images, near-infrared fluorescence (NIRAF) images, near-infrared fluorescence (NIRAF) images in a predetermined view, a carpet view, and / or an indicator view, a three-dimensional (3D) rendering, a 3D rendering of a vessel, a 3D rendering of a vessel in a semi-vascular view or representation, a 3D rendering of the object, a lumen profile, a lumen diameter representation, a longitudinal view, a computed tomography (CT), a magnetic resonance imaging (MRI) image, an X-ray image or view, and an angiographic view; displaying on a display an image of each of a plurality of imaging modalities, the plurality of imaging modalities including two or more of a tomographic image, an optical coherence tomography (OCT) image, a fluorescence image, a near infrared fluorescence (NIRAF) image, a near infrared fluorescence (NIRAF) image in a predetermined view, a carpet view, and / or an indicator view, a three-dimensional (3D) rendering, a 3D rendering of a blood vessel, a 3D rendering of a blood vessel in a semi-vascular view or representation, a 3D rendering of the object, a lumen profile, a lumen diameter representation, a longitudinal view, a computed tomography (CT), a magnetic resonance imaging (MRI), an intravascular ultrasound (IVUS), an X-ray image or view, and an angiography view; The apparatus of claim 1 , further operative to perform one or more of the following:

8. 1. A method of operating an imaging device to measure or determine one or more delay times and / or perform angiographic gating, comprising: the imaging device has one or more processors and a catheter or probe that includes or is in communication with one or more markers or radiopaque markers, the catheter or probe being used when one or more angiographic images of an object are acquired by the imaging device and is operable to acquire one or more intravascular images of the object; The method comprises: the one or more processors acquiring the one or more angiographic images of the object; acquiring, by the one or more processors, the one or more intravascular images at an acquisition location within a range of at least a portion of the object, the one or more angiographic images being acquired before, after, or simultaneously with the acquisition of the one or more intravascular images, the one or more angiographic images being acquired from a first data source and the one or more intravascular images being separately acquired from a second data source; the one or more processors estimating or determining the delay time by measuring a delay time, which is a difference in latency between the first data source and the second data source, using a synchronization signal; Including, the imaging device further includes a rotating device having a stationary portion and a rotating portion, the stationary portion and the rotating portion each having a window or area, the window or area of ​​the rotating portion configured to overlap the window or area of ​​the stationary portion at one or more times during a rotation of the rotating portion; The method comprises: (i) on or using the angioframes, the one or more processors detect the frames containing partially or fully open windows or regions and calculate the open windows or regions for each image frame; and / or (ii) calculating the delay time by determining a peak time at which the calculated open window or area is maximum based on a signal represented by an overlap amount between at least the open window or area of ​​the rotating device and one or more open areas in one or more angio images, determining or identifying a corresponding time value for a corresponding portion or location of the optical signal, and calculating the time between the peak time and the corresponding time value determined or identified for the corresponding portion or location of the optical signal; The method further comprises:

9. the optical signal is or includes one or more of excitation light, light operable to generate an OCT image, near-infrared fluorescence (NIRF), and near-infrared autofluorescence (NIRAF); The one or more processors: (i) further functioning to control the device and the catheter or probe using or for signal light or NIRF light and / or NIRAF light, or the modality of the NIRF light and / or NIRAF light, to be in a ready state, and / or to prepare the rotating portion of the rotating device to rotate for pullback; (ii) further operable to initiate the pullback, turn on the optical signal or a source of the optical signal, and trigger rotation of the rotating part of the rotating device to rotate one or more revolutions under an angio image view; and / or (iii) further operable to detect the frames in which the light source of the optical signal or the NIRF and / or NIRAF light is on by detecting the optical signal or the NIRF and / or NIRAF light on or with the one or more intravascular images and finding a center, middle, or other predetermined portion of the optical signal or the NIRF and / or NIRAF signal; The method of claim 8.

10. the stationary portion is fixed to a base or other location of the rotating device, and the rotating portion is operable to rotate about an axis on or adjacent to the stationary portion, whereby the rotating portion acts as a shutter, the shutter being open when the window or area of ​​the rotating and stationary portions partially or completely overlap, and otherwise closed; The method comprises: (i) displaying or presenting the overlapped windows or areas from the closed position or state of the shutters to the maximum fully overlapped area of ​​the windows or areas at the peak time; (ii) measuring the size of the window or region in each image frame of the one or more intravascular images and / or in each frame of the one or more angiographic images; (iii) if the peak time is between frames, interpolating the peak time using two adjacent frames to refine the location of the peak time; The method of claim 8 further comprising:

11. (i) displaying a graphical user interface (GUI) on a display, the GUI operable to manage delay time information for multiple operating rooms (ORs) or other locations such that the device is configured for use at different locations; (ii) performing an initialization process that serves to add or include data about all of the ORs or other locations in the device; (iii) performing the estimation or determination of the delay times for each of all of the ORs and other locations for which data has been added or included in the device to estimate or determine a respective delay time for each location, and / or recording the respective estimated or determined delay times for each location, so that one or more estimated or determined delay times are recorded, to enable angio delay compensation to be applied to all pullbacks performed at each of all of the ORs and other locations; The method of claim 8 further comprising:

12. The object includes a tube containing blood or a tube from which blood has been flushed. The method of claim 8.

13. co-registering the one or more acquired angiographic images with the one or more acquired intravascular images; co-registering the one or more acquired angiographic images and the one or more intravascular images, wherein the one or more angiographic images and the one or more intravascular images are of a plurality of imaging modalities, the plurality of imaging modalities including one or more optical coherence tomography (OCT) images or frames or intravascular ultrasound (IVUS) images or frames, tomographic images, fluorescence images, near-infrared fluorescence (NIRAF) images, near-infrared fluorescence (NIRAF) images in a predetermined view, carpet view, and / or indicator view, three-dimensional (3D) renderings, 3D renderings of blood vessels, 3D renderings of blood vessels in a semi-vascular view or representation, 3D renderings of the object, lumen profiles, lumen diameter representations, longitudinal views, computed tomography (CT), magnetic resonance imaging (MRI) images, X-ray images or views, and angiographic views; and / or displaying on a display an image of each of a plurality of imaging modalities, the plurality of imaging modalities including two or more of tomographic images, optical coherence tomography (OCT) images, fluorescence images, near infrared fluorescence (NIRAF) images, near infrared fluorescence (NIRAF) images in predetermined views, carpet views and / or indicator views, three-dimensional (3D) renderings, 3D renderings of blood vessels, 3D renderings of blood vessels in semi-vascular views or representations, 3D renderings of the object, lumen profiles, lumen diameter representations, longitudinal views, computed tomography (CT), magnetic resonance imaging (MRI), intravascular ultrasound (IVUS), X-ray images or views, and angiography views; The method of claim 8 further comprising:

14. 1. A non-transitory computer-readable storage medium having stored thereon at least one program for causing a computer to execute a method for operating an imaging device to measure or determine one or more angio delay times and / or perform angiographic gating, the method comprising: the imaging device has one or more processors and a catheter or probe that includes or is in communication with one or more markers or radiopaque markers, the catheter or probe being used when one or more angiographic images of an object are acquired by the imaging device and is operable to acquire one or more intravascular images of the object; The method comprises: the one or more processors acquiring the one or more angiographic images of the object; acquiring, by the one or more processors, the one or more intravascular images at an acquisition location within a range of at least a portion of the object, the one or more angiographic images being acquired before, after, or simultaneously with the acquisition of the one or more intravascular images, the one or more angiographic images being acquired from a first data source and the one or more intravascular images being separately acquired from a second data source; the one or more processors estimating or determining the delay time by measuring a delay time, which is a difference in latency between the first data source and the second data source, using a synchronization signal; Including, the imaging device further includes a rotating device having a stationary portion and a rotating portion, the stationary portion and the rotating portion each having a window or area, the window or area of ​​the rotating portion configured to overlap the window or area of ​​the stationary portion at one or more times during a rotation of the rotating portion; The method comprises: (i) on or using the angioframes, one or more processors detect the frames containing partially or fully open windows or regions and calculate the open windows or regions for each image frame; and / or (ii) calculating the delay time by determining a peak time at which the calculated open window or area is maximum based on a signal represented by an overlap amount between at least the open window or area of ​​the rotating device and one or more open areas in one or more angio images, determining or identifying a corresponding time value for a corresponding portion or location of the optical signal, and calculating the time between the peak time and the corresponding time value determined or identified for the corresponding portion or location of the optical signal; 10. A non-transitory computer-readable storage medium, further comprising:

Images