Automatic pullback triggering method for intracoronary imaging device or system using blood clearance

Abstract

The present invention relates to an automatic pullback triggering method for an intracoronary imaging device or system using blood clearance. Provided herein are one or more devices, systems, methods, and storage media for optical imaging medical devices (such as, but not limited to, optical coherence tomography (OCT), single-mode OCT, and / or multi-mode OCT devices and systems, and methods and storage media used therewith) for triggering automatic pullback, including for devices or systems using blood clearance. Examples of applications include imaging, evaluation, and diagnosis of biological objects, such as, but not limited to, for gastrointestinal, cardiac, and / or ophthalmic applications, and obtained via one or more optical instruments such as, but not limited to, optical probes, catheters, capsules, and needles (e.g., biopsy needles). The technology provided herein also improves processing and imaging efficiency while achieving more accurate images.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is related to and claims priority to U.S. patent application serial No. 63 / 062,300 filed on August 6, 2020, the entire disclosure of which is incorporated herein by reference in its entirety. Technical Field

[0003] The present disclosure relates generally to computer imaging and / or to the field of optical imaging, and in particular to devices, systems, methods, and storage media for using multiple imaging modalities such as, but not limited to, optical coherence tomography (OCT), multimodal OCT (MM-OCT), near-infrared autofluorescence (NIRAF), etc. Examples of OCT applications include imaging, evaluating, and diagnosing biological objects, such as, but not limited to, for gastrointestinal, cardiac, and / or ophthalmic applications, and obtained via one or more optical instruments, such as, but not limited to, one or more optical probes, one or more catheters, one or more endoscopes, one or more capsules, and one or more needles (e.g., biopsy needles). One or more devices, systems, methods, and storage media for performing auto-pullback triggering are discussed herein. Background Art

[0004] Optical coherence tomography (OCT) is an imaging modality that has been introduced as the method of choice for high-resolution intracoronary imaging. The concept of this technique is similar to intracoronary ultrasound, but instead of measuring the backscattered acoustic signal, it measures the delay of the backscattered light. However, since light cannot penetrate soft tissue and blood, blood flushing with a radiographic contrast agent is required. The blood flushing occurs before the pullback begins and needs to be controlled by a well-trained and experienced expert.

[0005] Fiber optic catheters and endoscopes have been developed to access internal organs. For example, in cardiology, OCT has been developed to view deep resolved images of blood vessels using a catheter. A catheter, which may include a sheath, coils, and an optical probe, may be navigated to the coronary arteries. In this way, OCT can be used for high-resolution intracoronary imaging.

[0006] OCT is a technique for obtaining high-resolution cross-sectional images of tissues or materials, and can realize real-time visualization. The purpose of OCT technology is to measure the time delay of light by using an interference optical system or interferometry, such as via Fourier transform or Michelson interferometer. The light from the light source is transmitted and split into a reference arm and a sample (or measurement) arm by a splitter (e.g., a beam splitter). The reference beam is reflected from a reference mirror (partial reflection 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 and an interference pattern is generated. The output of the interferometer is detected with one or more detectors, such as but not limited to a photodiode or a multi-array camera, in one or more devices, such as but not limited to a spectrometer (e.g., a Fourier transform infrared spectrometer). When the path length of the sample arm matches the path length of the reference arm and is within the coherence length of the light source, an interference pattern is generated. By evaluating the output beam, the spectrum of the input radiation can be derived as a function of frequency. The frequency of the interference pattern corresponds to the distance between the sample arm and the reference arm. The higher the frequency, the greater the difference in path length.

[0007] OCT measures the delay of backscattered light. However, since light cannot penetrate soft tissue and blood, blood flushing using radiocontrast agents can be used. Blood flushing occurs before the pullback begins and is controlled by a well-trained and experienced expert. Since the OCT pullback speed is extremely fast (~2sec / ~62:100mm pullback), it is crucial to start the pullback immediately when the blood is cleared in order to ensure the imaging of the entire target vessel. Unsynchronized flushing and pullback often result in the loss of imaging of the vascular portion, and a second pullback may be required. Moreover, because the blood-clearing contrast agent must be at a specific dose level, the possible second pullback required due to the first asynchronous flushing may be harmful to the patient or constitute a clinical risk, and may burden the physician or other expert clinician. Therefore, a method for detecting the absence of blood and triggering automatic pullback is introduced. However, this method is complex (for example, involving multiple parameters that should be modified by the user to adjust the behavior of the flushing and clearing state) and requires the user to update different thresholds.

[0008] Thus, a method is needed to detect the blood clearance status in a vessel or target area and automatically trigger the pullback without any user interaction. In fact, there is a need to provide reliable and efficient measurement for the entire OCT pullback.

[0009] Thus, it is desirable to provide at least one imaging or optical device, system, method and storage medium for using, controlling and / or emphasizing one or more imaging modalities, for example, by using one or more methods that utilize blood clearance to trigger automatic pullback and / or provide reliable and efficient measurement and imaging for the entire OCT pullback. Summary of the invention

[0010] Thus, a broad object of the present disclosure is to provide imaging (e.g., OCT, NIRAF, etc.) devices, systems, methods, and storage media for using and / or controlling an automatic pullback triggering method utilizing blood removal in one or more devices or systems (e.g., an intracoronary imaging device or system). A broad object of the present disclosure is also to provide OCT devices, systems, methods, and storage media using an interferometric optical system such as an interferometer (e.g., SD-OCT, SS-OCT, MM-OCT, etc.).

[0011] In one or more embodiments, at least one method can detect a clearance state of blood in a target object, sample, or region (e.g., a vessel) and can automatically trigger a pullback (e.g., without any user interaction, without requiring user interaction, etc.). As such, in one or more embodiments, the entire target object, sample, or region (e.g., a vessel) can be imaged, thereby minimizing the risk of contrast overdose (e.g., reducing, avoiding, or minimizing radiographic contrast overdose by limiting, minimizing, or avoiding the use of contrast agents).

[0012] One or more embodiments of the present disclosure overcome the above-mentioned problems and provide (one or more) automatic pullback methods that do not require user interaction. One or more automatic pullback method embodiments may include: (a) importing multiple A lines, images, or multiple images; (b) initializing a counter; (c) segmenting the A line, image, or multiple images; (d) dividing the segmented A line, image, or multiple images into three or more equal parts; (e) defining a blood imaging area (BIA), which is an area surrounding the imaging probe in the presence of blood; (f) detecting the number of objects within the BIA in a first frame of the segmented A line, image, or multiple images; (g) performing a counting step: when the number of objects is less than N, where N is the minimum accepted number of objects that define a partially cleared or cleared state, increasing the counter by a set or predetermined number or 1, and when the number of objects is N or more, repeating steps (c)-(g) for a second frame or subsequent frames; and (h) ending a signal to trigger a pullback when the counter is X or greater, where X is a predetermined value. One or more additional automatic pullback method embodiments may include: (i) importing the A-line (polar coordinate image) of the current frame in scanning mode (e.g., for a catheter or probe spinning at full speed), preparing the frame for the next step by removing the catheter or probe and extravascular noise, and setting a counter to zero; (ii) segmenting each image using automatic thresholding and dividing the image into four equal parts corresponding to the four Cartesian quadrants; (iii) removing any detected objects (e.g., small objects, objects of a predetermined size, etc.) that may correspond to noise, residual blood, or other artifacts, and counting how many objects overlap the blood imaging area (BIA) (also known as the blood imaging depth (BID) area). The BIA is defined or represented as the area that is more than a certain distance from the catheter tip that is predefined using images with blood present; (iv) if at least three (3) objects do not overlap the BIA, then increment the counter to one; if not, then move to the next frame; and (v) when the counter equals three, five, etc. (or another predetermined or set number), triggering automatic pullback.

[0013] One or more embodiments may provide one or more of the following advantages or benefits: (i) by dividing the image into three or more (e.g., four) parts / quadrants and studying the flushing state in each part, the method ensures that the flushing state can be detected even in small diameter blood vessels (e.g., when the diameter of the blood vessel is small, it is difficult to distinguish between blood, lumen and catheter or probe objects (the catheter or probe often contacts the wall of the lumen or blood vessel); (ii) by applying a counter in at least one method embodiment, optimal pullback flushing synchronization can be achieved (e.g., clear sequential frames can be detected before the pullback starts, thereby avoiding imaging loss); and / or (iii) by applying one or more features of the present disclosure, user interaction is not required or can be optional because automatic thresholding is performed.

[0014] One or more embodiments of the present disclosure may relate to a method for triggering automatic pullback during imaging (e.g., intravascular imaging), and may include the following: synchronizing flushing in imaging (e.g., OCT imaging) and catheter or probe pullback status; reducing or minimizing medical specialist tasks during intravascular imaging; reducing or minimizing pullback imaging loss due to late or early pullback triggering; and preventing the use of or avoiding a second flush, thereby reducing or minimizing risks to the patient.

[0015] In one or more embodiments, the cleared lumen state can be detected in three or more or four sections / quadrants. In one or more embodiments, the flushed state can be detected even in small diameter vessels. Detecting four quadrants of moving binary objects in small diameter vessels is more robust than comparing radii / rings, which may be very close due to the small diameter of the artery.

[0016] One or more embodiments may include a counter. Measuring how many consecutive frames have a blood clear state is at least one way to ensure that optimal pullback-flush synchronization is achieved. In one or more embodiments, the counter features the same or similar clear states in consecutive frames.

[0017] In one or more embodiments without user interaction, one or more methods thereof do not require the user to modify any (one or more) parameters to adjust the behavior of the flushing and clearing state (e.g., when the algorithm or method fails). In fact, reducing or avoiding user interaction improves efficiency and reduces (one or more) errors.

[0018] In one or more embodiments, one or more A-lines and / or real-time lumen distance calculations may be processed as discussed in U.S. patent application Ser. No. 63 / 046,495, filed on June 30, 2020, which is incorporated herein by reference in its entirety.

[0019] Lumen edge detection in OCT imaging may be susceptible to artifacts, which correspond to many features, including but not limited to: (one or more) stent struts, (one or more) guidewires, image brightness changes due to imaging angles, sheath reflections, irregular shapes of blood vessel cross sections, etc. Certain applications of OCT (such as multimodal OCT (MMOCT) systems / devices) can use lumen edge detection to correct for near-infrared autofluorescence (NIRAF) or near-infrared fluorescence (NIRF) signal distance attenuation. Preferably, accurate, real-time NIRAF or NIRF imaging uses accurate detection of lumen edges in real time based on a single frame of OCT images. See, for example, U.S. Patent Publication 2019 / 0298174, U.S. Patent Application Serial No. 16 / 131,662, and U.S. Patent Application Serial No. 62 / 925,655, all of which are incorporated herein by reference in their entirety. Accurate detection of lumen edges using a single OCT frame helps to improve the measurement accuracy of an overall object or target (such as a blood vessel), including for post-processing.

[0020] The present disclosure describes a means to allow an OCT user to focus to a region of interest and / or perform an automatic pullback trigger in all imaging modalities, such as, but not limited to, tomographic images, near infrared fluorescence (NIRAF) information in a carpet view, three-dimensional (3D) rendering of coronary vessels in a hemi-tube display, lumen diameter display, longitudinal views, and angiographic views. This allows the user to obtain a complete view of structural vascular information using one or more modalities and allows for configuration capabilities of the functionality to obtain a more targeted focus while providing (one or more) fast, efficient A-line lumen segmentation methods.

[0021] According to one or more embodiments of the present disclosure, an apparatus and system as well as a method and storage medium for automatic retraction triggering may be operable to characterize biological objects such as, but not limited to, blood, mucus, tissue, and the like.

[0022] It should be noted that one or more embodiments of the disclosed automatic pullback triggering method(s) may be used in other imaging systems, devices or apparatuses, where images are formed by signal reflection and scattering within tissue samples using a scanning probe. For example, IVUS images may be processed in addition to or instead of OCT images.

[0023] One or more embodiments of the present disclosure may be used in (one or more) clinical applications, such as, but not limited to, intervascular imaging, intravascular imaging, atherosclerotic plaque assessment, cardiac stent assessment, intracoronary imaging using blood clearance, balloon sinuplasty, sinus stent implantation, arthroscopy, ophthalmology, otology research, veterinary use and research, and the like.

[0024] In accordance with at least another aspect of the present disclosure, one or more of the techniques discussed herein may be used as features or in conjunction with features to reduce the cost of at least one of manufacturing and maintaining one or more devices, equipment, systems, and storage media by reducing or minimizing the number of optical and / or processing components and cutting the use / manufacturing cost of such devices, equipment, systems, and storage media by leveraging efficient technology.

[0025] The following paragraphs describe certain illustrative embodiments. Other embodiments may include alternatives, equivalents, and modifications. In addition, the illustrative embodiments may include several novel features, and certain features may not be necessary for some embodiments of the devices, systems, and methods described herein.

[0026] 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 using OCT and / or other (one or more) imaging modality techniques are discussed herein. Further features of the present disclosure will be partially understandable and partially apparent from the following description and with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] To illustrate various aspects of the present disclosure, in which like numbers indicate like elements, simplified forms that may be used are shown in the drawings, but it should be understood that the present disclosure is not limited or restricted to the precise arrangements and tools shown. To assist those skilled in the relevant art in making and using the subject matter, reference is made to the drawings, in which:

[0028] Figure 1 is a schematic diagram illustrating at least one embodiment of a system according to one or more aspects of the present disclosure, which system may be used to perform one or more embodiments of a real-time lumen distance calculation method(s) based on 3D A-line signal data;

[0029] Figure 2 is a diagram of an embodiment of a catheter or probe according to one or more aspects of the present disclosure that can be used with at least one embodiment of an apparatus, method, or system for performing an A-line lumen distance calculation technique;

[0030] Figure 3 is a schematic description of at least one embodiment of flush pullback synchronization (points A and B represent the start and end of a target segment, respectively) according to one or more aspects of the present disclosure;

[0031] Figure 4 Before an example of an automatic pull-back algorithm or method embodiment according to one or more aspects of the present disclosure (for example, an automatic pull-back algorithm or method embodiment can integrate three tasks into one to reduce or minimize the user's work) ( Figure 4 of the top) and after ( Figure 4 A schematic description of at least one embodiment of a user task of FIG. 1 ;

[0032] Figure 5 is a flow chart of at least one embodiment of an automatic pullback triggering method according to one or more aspects of the present disclosure;

[0033] Figure 6 At least one embodiment example of scanning mode setting of an OCT device or system and at least one embodiment of preprocessing of a current frame according to one or more aspects of the present disclosure are shown;

[0034] Figure 7 is at least one embodiment example of object detection and A-line and OCT image quadrant correspondence according to one or more aspects of the present disclosure;

[0035] Figure 8 shows a schematic depiction of at least one embodiment of an automatic pullback method for an image with blood (top panel) and a washout image (bottom panel) in accordance with one or more aspects of the present disclosure;

[0036] Fig. 9 shows a sensitivity analysis of object deletion percentage threshold(s) according to one or more aspects of the present disclosure;

[0037] Fig.10 OCT imaging of blood according to one or more aspects of the present disclosure is shown ( Fig.10 ) and at least one embodiment of a circular area that includes a majority of the image or imaged blood ( Fig.10 on the right side);

[0038] Fig.11 FIG. 4 shows the blood imaging length (=T ) before blood flushing occurs according to one or more aspects of the present disclosure. dis ) (e.g., when blood is present, OCT allows for a specific or predetermined imaging depth—also referred to herein as a blood imaging area (BIA));

[0039] Fig.12 At least one corresponding embodiment example of two application examples according to one or more aspects of the present disclosure is shown, one is a non-flushing frame ( Fig.12 ), one is the flush frame ( Fig.12 ) (e.g., in one or more embodiments, the number of moving objects detected on the developed image may be four (4) and zero (0) on the non-developed image);

[0040] Fig.13is a summary of MMOCT pullbacks used in experiments performed according to one or more aspects of the present disclosure;

[0041] Figures 14A-14B Included are graphs showing the difference (difference in number of frames and number of pullbacks) between the results obtained by Expert 1 and Expert 2 in the experiments conducted according to one or more aspects of the present disclosure ( Fig.14A ) and the differences between the algorithm or method embodiment used and the expert ( Fig. 14B )

[0042] Figures 15A-15B including graphs and corresponding longitudinal views showing example embodiments of qualitative evaluation of at least one embodiment of an automated pullback method or algorithm in two different pullbacks according to one or more aspects of the present disclosure;

[0043] Figures 16A-16Q including qualitative results of longitudinal views of seventeen (17) pullbacks performed in experiments using an automated pullback method or algorithm in accordance with one or more aspects of the present disclosure;

[0044] Fig.17 is a graph illustrating the time complexity of at least one automatic pullback method or algorithm embodiment according to one or more aspects of the present disclosure when processing 2500 frames;

[0045] Fig.18 At least one embodiment of an OCT device or system for utilizing one or more embodiments of automatic pullback triggering methods and / or techniques according to one or more aspects of the present disclosure is shown;

[0046] Fig.19 At least another embodiment of an OCT device or system for utilizing one or more embodiments of automatic pullback triggering methods and / or techniques according to one or more aspects of the present disclosure is shown;

[0047] Fig. 20 At least another embodiment of an OCT device or system for utilizing one or more embodiments of automatic pullback triggering methods and / or techniques according to one or more aspects of the present disclosure is shown;

[0048] Fig.21 is a flow chart illustrating a method of performing an imaging feature, function, or technique according to one or more aspects of the present disclosure;

[0049] Fig. 22 A schematic diagram showing an embodiment of a computer according to one or more aspects of the present disclosure, which embodiment of the computer can be used with one or more embodiments of the apparatus or system or one or more methods discussed herein; and

[0050] Fig.23 A schematic diagram of another embodiment of a computer according to one or more aspects of the present disclosure is shown, which embodiment of the computer can be used with one or more embodiments of the imaging device or system or method discussed herein. DETAILED DESCRIPTION

[0051] Disclosed herein are one or more devices, systems, methods, and storage media for characterizing tissues, objects, or samples using one or more imaging and / or computing techniques or modalities (such as, but not limited to, OCT, NIRAF, etc.). Figures 1 to 23 Several embodiments of the present disclosure that may be performed by one or more embodiments of the apparatus, system, method, and / or computer-readable storage medium of the present disclosure are illustrated and visually described in the accompanying drawings.

[0052] In one or more embodiments, at least one method can detect a clearance state of blood in a target object, sample, or region (e.g., a vessel), and can automatically trigger a pullback (e.g., without any user interaction, without requiring user interaction, etc.). As such, in one or more embodiments, the entire target object, sample, or region (e.g., a vessel) can be imaged, thereby minimizing the risk of contrast overdose (e.g., reducing, avoiding, or minimizing radiographic contrast overdose).

[0053] One or more embodiments of the present disclosure may relate to a method for triggering automatic pullback during imaging (e.g., intravascular imaging), and may include the following: synchronizing flushing and catheter or probe pullback status in imaging (e.g., OCT imaging); reducing or minimizing medical specialist tasks during intravascular imaging; reducing or minimizing pullback imaging loss due to late or early pullback triggering; and preventing the use of or avoiding a second flush, thereby reducing or minimizing risks to the patient.

[0054] One or more embodiments may provide one or more of the following advantages or benefits: (i) by dividing the image into four parts / quadrants and studying the flushing state of each part, the method ensures that the flushing state can be detected even in small diameter blood vessels (for example, when the diameter of the blood vessel is small, it is difficult to distinguish between blood, lumen and catheter or probe objects (the catheter or probe often contacts the wall of the lumen or blood vessel)); (ii) by applying a counter in at least one method embodiment, optimal pullback flushing synchronization can be achieved (for example, clear sequential frames can be detected before the pullback starts, thereby avoiding imaging loss); and / or (iii) by applying one or more features of the present disclosure, user interaction is not required or can be optional because automatic thresholding is performed.

[0055] One or more embodiments of the present disclosure can overcome the above problems and can provide (one or more) automatic pullback methods that do not require user interaction. One or more automatic pullback method embodiments may include: (i) importing the A-line (polar coordinate image) of the current frame in scanning mode (e.g., for a full-speed spinning catheter or probe), preparing the frame for the next step by removing the catheter or probe and extravascular noise, and setting a counter to zero; (ii) using automatic thresholding to segment each image and divide the image into four equal parts corresponding to the four Cartesian quadrants; (iii) removing any detected objects (e.g., small objects, objects of predetermined size, etc.) that may correspond to noise, residual blood or other artifacts, and counting how many objects overlap with the blood imaging area (BIA). The BIA can be represented or defined as an area above a certain distance from the catheter tip, which is predefined using images with blood present; (iv) if at least three (3) objects do not overlap with the BIA, then increment the counter to one or increase by one; if not, then move to the next frame; and (v) when the counter is equal to three, five, etc. (or another predetermined or set number), triggering automatic pullback.

[0056] In one or more embodiments, the cleared lumen state can be detected in four sections / quadrants. In one or more embodiments, the flushed state can be detected even in small diameter vessels. Detecting moving binary objects in four quadrants in small diameter vessels is more robust than comparing radii / rings, which may be very close due to the small diameter of the artery.

[0057] One or more embodiments may include a counter. Measuring how many consecutive frames have a blood clear state is at least one way to ensure that optimal pullback-flush synchronization is achieved. In one or more embodiments, the counter ensures that the same or similar clear state is in consecutive frames.

[0058] In one or more embodiments without user interaction, one or more methods thereof do not require the user to modify any (one or more) parameters to adjust the behavior of the flushing and clearing state (e.g., when the algorithm or method fails). In fact, reducing or avoiding user interaction improves efficiency and reduces (one or more) errors.

[0059] Intravascular optical coherence tomography (IV-OCT) is an imaging technique for imaging the surface and portions of the arterial wall of a human artery. IV-OCT measures the delay of backscattered light to image the artery. OCT is commonly used in interventional cardiology and is becoming the method of choice for many applications, including but not limited to imaging coronary artery disease. In order to image the coronary arteries, a catheter or probe (e.g., catheter or probe 120) can be inserted through the femoral artery, and by using a guidewire, the catheter or probe can be placed in the target coronary artery. The catheter or probe (e.g., catheter or probe 120) can spin around itself to emit light, and then a pullback along the target vessel or other target, object or sample (e.g., target, object or sample 106) can be performed. During retraction of a catheter or probe (e.g., catheter or probe 120), reflected optical signals (e.g., A-line images (e.g., OCT images in polar coordinates, images in polar coordinates, images of a specific imaging modality in polar coordinates, etc.)) can be stored, transformed into Cartesian coordinates (2D OCT frames), and presented to a user and / or displayed on a display screen.

[0060] Turning now to the details of the drawings, processing intravascular imaging data and / or performing (one or more) automatic pullback triggering methods can be performed in one or more ways as discussed herein. One or more displays discussed herein can allow a user of the one or more displays to use, control and / or emphasize one or more imaging and / or computing techniques or modalities, such as but not limited to OCT, NIRAF, etc., and can allow a user to use, control and / or emphasize one or more imaging techniques or modalities simultaneously, and / or can allow a user to perform (one or more) automatic pullback triggering methods (including (one or more) methods involving blood removal) and / or process intravascular imaging data.

[0061] like Figure 1 As schematically shown in , one or more embodiments of the system or device disclosed herein for visualizing, emphasizing and / or controlling one or more imaging modalities and / or for performing (one or more) automatic pullback triggering methods (including (one or more) methods involving blood clearance) and / or processing intravascular imaging data may involve one or more predetermined or desired procedures, such as but not limited to medical procedure planning and execution.

[0062] Figure 1An OCT system 100 (referred to herein as "system 100" or "the system 100") according to one or more aspects of the present disclosure is shown, which is operated to use OCT technology with optical probe applications, including but not limited to allowing a user to synchronously use, control and / or emphasize one or more imaging techniques or modalities and / or allowing execution of (one or more) automatic pullback trigger methods (including (one or more) methods involving blood removal) and / or processing one or more embodiments of the intravascular imaging data technology discussed herein. 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 reflector") 105, and one or more detectors 107. System 100 may include a phase shifting device or unit 130, and 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 (such as Figure 1-2 ), and the system 100 can interact with a sample or target 106 (e.g., via a catheter / probe 120 and / or a PIU 110). In one or more embodiments, the system 100 includes an interferometer, or the interferometer is defined by one or more components of the system 100 (such as, but not limited to, at least a light source 101, a reference arm 102, a sample arm 103, a splitter 104, and a reference mirror 105).

[0063] The light source 101 is operated to generate light to the splitter 104, which splits the light from the light source 101 into a reference beam entering the reference arm 102 and a sample beam entering the sample arm 103. The beam splitter 104 is positioned or arranged at an angle to the reference mirror 105, one or more detectors 107, and the sample or target 106. The reference beam passes through the phase shift unit 130 (when included in the system, as shown in the system 100), and the reference beam is reflected from the reference mirror 105 in the reference arm 102, while the sample beam is reflected or scattered from the sample 106 through the PIU (patient interface unit; also referred to herein as the patient interface component (PIC)) 110 and the catheter or probe 120 in the sample arm 103. Both the reference beam and the sample beam are combined (or recombined) at the splitter 104 and generate an interference pattern. The output of the system 100 and / or its interferometer is continuously acquired by one or more detectors 107 (such as but not limited to photodiodes or multi-array cameras). One or more detectors 107 measure the interference or interference pattern between the two radiation or light beams that are combined or recombined. In one or more embodiments, the reference beam and the sample beam have traveled different optical path lengths so that a fringe effect occurs and can be measured by one or more detectors 107. The electrical analog signals obtained from the output of the system 100 and / or its interferometers are converted into digital signals for use with a computer (such as, but not limited to, computer 1200, 1200'( Fig. 22 or Fig.23 In one or more embodiments, the light source 101 may be a radiation source or a broadband light source that radiates over a wide wavelength band. In one or more embodiments, a Fourier analyzer including software and electronics may be used to convert the electrical analog signal into a spectrum.

[0064] The light source 101 may include multiple light sources or may be a single light source. In one or more embodiments, the light source 101 generates broadband lasers. The light source 101 may include one or more of a laser, an organic light emitting diode (OLED), a light emitting diode (LED), a halogen lamp, an incandescent lamp, a supercontinuum light source pumped by a laser, and / or a fluorescent lamp. The light source 101 may be any light source that provides light, which may then be split into at least three bands, each of which is further dispersed to provide light that is subsequently used for spectral encoding of spatial information. The light source 101 may be coupled to one or more systems discussed herein (such as, but not limited to, system 100, system 100', system 100", system 100'", etc.) by optical fiber coupling or by free space coupling.

[0065] According to at least one aspect of the present disclosure, features of an OCT system are implemented using optical fibers. As mentioned above, one application of the OCT technology of the present disclosure is to use an OCT with a catheter or probe 120, such as Figure 1-2 As shown schematically in FIG.

[0066] Figure 2 1 shows an embodiment of a catheter 120, which includes a sheath 121, a coil 122, a protector 123, and an optical probe 124. Figure 1-2 As schematically shown in , the catheter 120 is preferably connected to the PIU 110 to spin the coil 122 using pullback (e.g., at least one embodiment of the PIU 110 is operative to spin the coil 122 using pullback). The coil 122 transmits torque from its proximal end to its distal end (e.g., via or through a rotary motor in the PIU 110). In one or more embodiments, the coil 122 is fixed / fixed to the optical probe 124 together with the optical probe 124 so that the distal tip of the optical probe 124 also spins to see an omnidirectional view of the biological organ, sample, or material being evaluated (such as but not limited to a hollow organ such as a blood vessel, heart, etc.). For example, the fiber optic catheter and endoscope can reside in a sample arm of an OCT interferometer (such as sample arm 103, as shown in Figure 1 ) in order to provide access to internal organs, such as intravascular images, the gastrointestinal tract, or any other narrow areas that are difficult to access. As the light beam through the catheter 120 or the optical probe 124 inside the endoscope rotates over the surface of interest, a cross-sectional image of one or more samples is obtained. In order to obtain three-dimensional data, the optical probe 124 is simultaneously translated longitudinally during the rotational spin, thereby generating a spiral scanning pattern. This translation can be performed by pulling the tip of the probe 124 back toward the proximal end, and is therefore referred to as a pullback.

[0067] In one or more embodiments, the patient user interface 110 may include or comprise a connection component (or interface module), such as a swivel joint, to connect one or more components, such as one or more components of the probe (e.g., the catheter 120 (see, e.g., Figure 1-2)), needles, capsules, patient interface units or components (e.g., patient interface unit or assembly 110), etc., connected to one or more other components, such as optical components, light sources (e.g., light source 101), deflection sections (e.g., such as a deflection or deflected section of a component that operates to deflect light from a light source to an interference optical system and then sends the light received from the interference optical system toward at least one detector; a deflection or deflected section including at least one of the following: one or more interferometers, circulators, beam splitters, isolators, couplers, fused fiber couplers, a partial partition mirror with holes therein, and a partial partition mirror with taps; etc.), sample arm 102, a motor that operates to provide energy to the connection components and / or the patient user interface 110, etc. For example, when the connection member or interface module is a rotary joint, preferably the rotary joint operates as discussed below. In one or more other embodiments, the rotary joint can be at least one of the following: a contact rotary joint, a lensless rotary joint, a lens-based rotary joint, or other rotary joints known to those skilled in the art.

[0068] In at least one embodiment, the PIU 110 can include a fiber optic rotary joint (FORJ), a rotary motor and a translation motorized platform (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 optical fiber along the fiber axis. The FORJ can have a free space optical beam combiner including a rotor and a stator.

[0069] Descriptions of like numbered elements present in system 100 ′ and already described above (such as for system 100 ) will not be repeated and are incorporated herein by reference in their entirety.

[0070] In at least one embodiment, the console 1200, 1200' operates to control the movement of the motor and translation motorized platform (hereinafter referred to as "motor" or "motor and platform"), acquire intensity data from at least one detector 107, and display the scanned image (e.g., on a monitor or screen, such as Fig. 22 Console 1200 and / or Fig.23 In one or more embodiments, the console 1200, 1200' is operated to change the speed of the motor and / or stop the motor. The motor can be a stepper or DC servo motor to control speed and improve position accuracy.

[0071] In one or more embodiments, the console or computer 1200, 1200' operates to control the system 100 (as well as other systems, such as but not limited to system 100', system 100", system 100'", etc., as further discussed below), the catheter 120, and / or one or more of the other aforementioned components of the system 100. In at least one embodiment, the console or computer 1200, 1200' operates to acquire intensity data from at least one detector 107 of the OCT system / device / apparatus and display (one or more) images (e.g., on a monitor or screen, such as Fig. 22 Console 1200 and / or Fig.23 The output of one or more components of the system 100 (and other systems, such as but not limited to system 100', system 100", system 100'", etc., as further discussed below) is acquired using at least one detector 107 of the OCT system / device / apparatus (such as but not limited to a photodiode, (one or more) photomultiplier tubes (PMTs), (one or more) line scan cameras, or (one or more) multi-array cameras). The electrical analog signal or one or more components thereof obtained from the output of the system 100 (and / or other systems, such as but not limited to system 100', system 100", system 100'", etc.) is converted into a digital signal for analysis using a computer (such as but not limited to computer 1200, 1200' (e.g., Figure 1 , 18 -20 and 22-23)) for analysis. In one or more embodiments, the light source 101 can be a radiation source or a broadband light source that radiates over a wide wavelength band. In one or more embodiments, a Fourier analyzer including software and electronic devices can be used to convert the electrical analog signal into a spectrum. In some embodiments, at least one detector 107 includes three detectors configured to detect three different light bands.

[0072] One or more features of the present disclosure may be employed or implemented using any OCT device and / or system and may be implemented using only minor modifications to the reference arm where the device and / or system uses a single reference arm path, one or more embodiments of the methods or techniques of the present disclosure may use two reference arm paths or the ability to fully adjust the reference arm delay in order to adjust the imaging FOV to be at the primary sample imaging position or approximately the system's most distal point (pairing position).

[0073] One or more embodiments of a system for increasing the imaging depth range may include: an OCT system; a reference reflector adjusted to see reflections from a system mating connector in the imaging field of view; and one or more processors operative to determine whether a catheter / probe is mated with the system mating connector.

[0074] As mentioned above, OCT measures the delay of backscattered light. However, since light cannot penetrate soft tissue and blood, radiocontrast agents can be used for blood washout.

[0075] In one or more embodiments, the blood clearing state can be synchronized with the catheter pullback to ensure that the entire arterial segment can be imaged. In one or more embodiments where the blood clearing state is not synchronized with the catheter or probe pullback, one or two scenarios may occur: (i) in the case of early pullback, the distal portion of the catheter or probe tip portion may not be imaged; and / or (ii) in the case of late pullback, the proximal portion of the catheter or probe may not be imaged in one or more embodiments. Figure 3 A schematic depiction of the pullback washout synchronization problem and possible imaging loss is shown in (eg, where points A and B represent the start and end of the target segment, respectively).

[0076] One or more method embodiments of the present disclosure ensure flush-pull synchronization and minimize the tasks of a user (eg, medical expert, professional, clinician, practitioner, etc.) during a catheterization procedure. Figure 4 As shown in , during intravascular imaging, there are currently four (4) manual tasks that the user needs to perform serially (e.g., press four (4) separate buttons to control live mode speed, control scan mode speed, cause flushing to occur, cause pullback to occur, etc.) (see e.g. Figure 4 One or more method embodiments integrate at least three tasks (e.g., controlling scan mode speed, causing flushing to occur, causing pullback to occur, etc.) into one task (see, e.g., Figure 4 In one or more embodiments, the user may not have to press a button or otherwise interact with the system or device at all, and the device or system may be operable to automatically trigger the pullback without any user interaction.

[0077] One or more automatic pullback method embodiments may include: (a) importing multiple A-lines, images, or multiple images; (b) initializing a counter; (c) segmenting the A-line, image, or multiple images; (d) dividing the segmented A-line, image, or multiple images into three or more equal parts; (e) defining a blood imaging area (BIA), which is an area surrounding an imaging probe in the presence of blood; (f) detecting the number of objects within the BIA in a first frame of the segmented A-line, image, or multiple images; (g) performing a counting step: if the number of objects is less than N, where N is the minimum accepted number of objects that define a partially cleared or cleared state, increasing the counter by a set or predetermined number or 1, and if the number of objects is N or more, repeating steps (c)-(g) for a second frame or subsequent frames; and (h) ending a signal to trigger a pullback when the counter is X or greater, where X is a predetermined value. Now turn to Figure 5 , showing at least one embodiment example of an automatic pullback triggering method, at least one embodiment of the overall workflow of the method may include: (i) importing the A line (polar coordinate image) of the current frame of the image in scanning mode (e.g., for a catheter or probe spinning at full speed), preparing the frame for the next step by removing catheter or probe and extravascular noise or otherwise performing frame preprocessing, and setting a counter to zero (e.g., see respectively Figure 5 (ii) segmenting the image using automatic thresholding and dividing the image into four equal parts corresponding to the four Cartesian quadrants (see e.g. Figure 5 (iii) calculating the relative position of the object(s) to the blood imaging area (BIA) region, where the BIA is represented as the region above a certain distance (predefined using an image with blood present) from the catheter or probe tip (see e.g. Figure 5 (iv) removing any detected objects (e.g., small objects, objects of a predetermined size, etc.) that may correspond to noise, residual blood, or other artifacts, and counting how many objects are more than a certain distance from the BIA area or do not overlap with the BIA area, or counting how many objects overlap with the blood imaging area (BIA) (see, e.g., Figure 5 (v) if two (2) or more objects (or more than two objects) do not overlap with the BIA, increment a counter to one or by one (see, e.g., Figure 5 If not, then the counter is set to zero again, and / or moved to the next frame (see, e.g. Figure 5(vi) when the counter is equal to three, five, etc. (or another predetermined or set number), triggering automatic pullback (see, for example, Figure 5 14 and S118 in ); otherwise, if the counter is not yet equal to 3, 5, etc. (or another predetermined or set number, such as but not limited to 1, 2, 4, etc.), then move to the next A line frame and repeat steps S104 to S110.

[0078] In one or more embodiments, the step of calculating the relative position of the object(s) and the catheter or probe may be omitted (see, e.g. Figure 5 In one or more embodiments using BIA, the BIA is represented as an area above a certain distance (predefined using an image with blood present) from the catheter or probe tip (see, e.g., above for Figure 5 Step S108 discussed).

[0079] In one or more embodiments, the intracoronary or imaging system (see, e.g., step S100) may be set to scan mode (full scan speed) and the counter may be set to zero. Then, the current block of A-lines, referred to in this embodiment as an A-line image / frame, may be selected, which when converted to Cartesian coordinates forms a 2D OCT frame (see, e.g., step S102) and is prepared for processing. During process preparation or frame preprocessing (see, e.g., step S104), pixels corresponding to the catheter or probe and artifacts and / or extravascular tissue regions may be set to zero (see, e.g., step S105). Figure 6 ) and a mean filter (7x7) can be applied. Figure 6 At least one embodiment example of scanning mode setting of one or more OCT systems of the present disclosure and at least one embodiment of preprocessing of the current frame are shown. For example, the A-line image ( Figure 6 upper right image) and the catheter / probe and artifact areas can be removed.

[0080] Mean filtering:

[0081] The mean filter can be applied as a spatial filter. In one or more embodiments, the mean filter can be a sliding window (kernel) spatial filter that replaces the center value of the window with the average intensity value of the pixels belonging to the window. For an image I and a window of size NxN, the value of the center pixel (i, j) of the window is replaced by Where m,n are the pixels belonging to the window NxN.

[0082] In the next step (S106) of the method, the filtered image is processed as follows: i) applying Otsu's automatic thresholding, ii) smoothing the segmented image by removing small objects corresponding to image artifacts, and iii) dividing the image into four equal parts corresponding to the four Cartesian quadrants. In this step, the correspondence between the A-line and the OCT image quadrant is Figure 5 Although this step is visualized as four equal parts, the present disclosure provides for division into 2, 3, 5, 6, 7 or 8 equal parts. In addition, although the areas of these parts must be substantially equal, the equal parts can have some small variations in the exact number of pixels or A lines in each part.

[0083] In one or more embodiments, other types of filtering may be used, such as but not limited to Gaussian filtering, bilateral filtering, etc. For example, similar to a Gaussian filter, a bilateral filter is a nonlinear smoothing filter. The fundamental difference is that the bilateral filter takes into account pixel intensity differences, resulting in edge preservation while reducing noise. Using convolution, a weighted average of the neighborhood pixel intensities may replace the intensity of the center pixel of the mask. In one or more embodiments, a bilateral filter and a window mask W for an image I are defined as With normalization factor where x is the coordinate of the center pixel of the mask and the parameter f r and g s are the Gaussian kernel for smoothing intensity differences and the spatial Gaussian kernel for smoothing coordinate differences.

[0084] In one or more embodiments of step S106 (see, e.g. Figure 5 The filtered image may be processed and image segmentation may be applied as follows: (i) applying automatic thresholding, such as but not limited to Otsu automatic thresholding; (ii) smoothing the segmented image by removing small objects corresponding to image artifacts; and (iii) dividing the image into four equal parts corresponding to four Cartesian quadrants. In at least one embodiment of step S106, the correspondence between the A-line and the OCT image quadrant is from image thresholding to Figure 7 Presented in detail. Figure 7 At least one example of an embodiment of object detection and A-line correspondence to OCT image quadrants is shown. dis The values ​​are compared to determine whether the object is blood.

[0085] Figure 8 (It includes Figure 8 A schematic depiction of at least one embodiment of an automated pullback method for an image with blood (top panel) and a washed image (bottom panel) is shown in the top and bottom panels (parts A to D) of FIG. Figure 8 Part A of FIG. 1 shows an A-line image cleaned from a catheter or probe (eg, catheter or probe 120 ) and extravascular background. Figure 8 Part B of shows the image after thresholding, equal division and removal of small objects. Figure 8 Part C of FIG. 4 shows binary objects and BIA regions. Part D shows non-overlapping objects counted in the corresponding Cartesian image.

[0086] Otsu thresholding:

[0087] In one or more embodiments, in order to automatically threshold the A-line image, for example, the threshold T4r of the image I may be calculated using the Otsu method. otsu , and is smaller than T4r otsu The image pixels may be set to zero value. The result is a binary image in which the arterial wall and blood are represented by non-zero objects. Since non-zero objects may also correspond to image artifacts, an additional step may be applied in one or more embodiments: detecting objects that are smaller than a predetermined area, such as but not limited to the entire catheter or detection area, 3% of the entire image, etc. Using this additional step, one or more embodiments ensure that only objects corresponding to the wall area will be used to detect boundaries. In one or more embodiments, this additional step may include or may alternatively be: detecting larger objects and removing objects that are smaller than the larger object by a predetermined percentage (e.g., 24%, 20%, 25%, 30%, any value in the range of approximately 10% to approximately 50%, any value in the range of 10% to 50%, any value in the range of approximately 20% to approximately 30%, any value in the range of 20% to 30%, etc.). Fig. 9 Sensitivity analyses performed on the deletion percentage are shown in . Fig. 9 The left portion of FIG. 1 illustrates a box-and-whisker plot showing that for one or more embodiments, the ideal or optimal frame difference (in Fig. 9 The left part of the graph shows the overlap thresholds of 0.1 (91), 0.2 (92), 0.3 (93), 0.4 (94) and 0.5 (95) from left to right). Fig. 9 The right portion of FIG. 1 illustrates a box-and-whisker plot showing the ideal or optimal frame difference (in the range of 0.2-0.3 (20-30%)) achieved when using an object removal threshold of 0.24 (24%). Fig. 9 The right part of shows the overlap thresholds of 0.2, 0.21, 0.22, 0.23, 0.24, 0.25, 0.26, 0.27, 0.28, 0.29, and 0.3, respectively, from left to right).

[0088] In one or more embodiments of step S108, the relative position of (one or more) binary objects can be considered. For example, in one or more embodiments, the relative position of each detected binary object to the blood imaging area (BIA) can be calculated. The circular area above the catheter or probe tip can be represented as the BIA. This concept stems from the fact that blood surrounds the catheter or probe (e.g., catheter or probe 120) at a specific distance before flushing occurs and the lumen boundary is revealed. Fig.10 An example of the BIA region in the pre-wash image is shown in FIG, which shows an OCT image of blood ( Fig.10 ) and a circular area that includes most of the image or the imaged blood ( Fig.10 Using the BIA as a reference region, binary objects that overlap and do not overlap with the BIA can be calculated (see e.g. Figure 8 Part C).

[0089] Additionally or alternatively, in one or more embodiments of step S108, the relative position of each object may be calculated by counting how many binary objects are within a specific distance T from the catheter or probe (eg, catheter or probe 120). di2 Above. represents the catheter or probe distance, and in one or more embodiments, the number of pixels above a specific height forms the catheter or probe tip. The concept of insertion catheter or probe distance originates from the fact that blood surrounds the catheter or probe (e.g., catheter or probe 120) at a specific distance before flushing clears the blood and reveals the lumen boundary, and because OCT allows for a specific imaging depth in the presence of blood (see Fig.11 Example images shown in FIG; length of the blood imaging area (BIA) before blood flushing occurs. OCT allows for a specific imaging depth when blood is present). To define the BIA, the length depth is measured at different blood state images and the measurements are averaged. One or more algorithm or method embodiments are intended to detect how much an object has moved during blood imaging with OCT.

[0090] Depending on the relative position of each binary object, the algorithm(s) or method embodiments next determine a clearing condition for the processed frame (see, e.g., step S110). If the number of objects that do not overlap with the BIA is a predetermined threshold (e.g., 3) or more (in one or more embodiments, the threshold may be set to at least one or more of the following: 2 or more, 3 or more, 4 or more, 5 or more, a predetermined number or more, etc.), this means that the vessel wall becomes visible in the current frame. However, the visibility of the wall may vary from frame to frame (e.g., a wall may be visible in one frame, while the wall may not be visible in the next frame). This is due to the movement of the heart and blood vessels during systole and diastole and the variability of the irrigation pressure controlled by the user. Therefore, in one or more embodiments, from the start of the algorithm(s) or method(s), a counter is included and set to zero. In the case where the wall in the current frame is visible, the counter is incremented by one (see, e.g., step S112), otherwise the counter is set to zero again (see, e.g., S116). For example, in Fig.12 At least one embodiment with objects overlapping or not overlapping with the BIA is shown in FIG.

[0091] When the counter is incremented (S112), the next step is to check whether the arterial wall is visible for a predetermined number (e.g., three, four, five, six, etc.) of consecutive frames (e.g., when the counter is equal to 5 or a set predetermined number) (see, e.g., step S114). If "no", the algorithm moves to the next frame; otherwise, if "yes", a pullback is triggered (see, e.g., step S114). Having a counter ensures that blood is sufficiently cleared so that the pullback can be synchronized with the improved or optimal clearing state. In Fig.12 Two application examples are shown in Figure 1: one for an unflushed frame and one for a flushed frame; the detected object in the unflushed frame is zero (see Fig.12 Left), while in the flush frame, the number of detected objects is 4 (see Fig.12 Right side). In one or more embodiments, depending on the relative position of each binary object, (one or more) methods determine the clearing condition of the processed frame. If the number of objects that do not overlap with the BIA is greater than three (or another set or predetermined threshold), then this can indicate that the arterial wall is exposed or visible and blood is flushed (e.g., indicating a clear state). However, since blood clearance may be present in one frame and not in the next frame and in order to minimize clear state detection errors, a counter can be added. The counter is initially set to zero, can be increased by one each time a clear state is detected, and when the counter reaches a predetermined number (e.g., 3, 4, 5, etc.), a pullback can be initiated (see, e.g. Figure 3 , Figure 8 D, etc.).

[0092] One or more embodiments may provide one or more of the following advantages or benefits: (i) by dividing the image into four parts / quadrants and studying the flushing state of each part, the method ensures that the flushing state can be detected even in small diameter vessels (for example, when the diameter of the vessel is small, it is difficult to distinguish between blood, lumen and catheter or probe objects (the catheter or probe often contacts the wall of the lumen or vessel); (ii) by applying a counter in at least one method embodiment, optimal pullback flushing synchronization can be achieved (for example, clear sequential frames can be detected before the pullback starts, thereby avoiding imaging loss); and / or (iii) by applying one or more features of the present disclosure, user interaction is not required or can be optional because automatic thresholding is performed.

[0093] Although the present disclosure is not limited to the following features, one or more features of the present disclosure are summarized as follows:

[0094]

[0095] As noted above, one or more method embodiments of the present disclosure reduce the tasks during an OCT imaging procedure (e.g., for an expert, practitioner, clinician, etc.), reduce the likelihood of asynchronous flush-pullback occurring, and ensure that the entire target vessel (or other predetermined target) is or will be imaged.

[0096] One or more embodiments of the present disclosure may relate to a method for triggering automatic pullback during imaging (e.g., intravascular imaging), and may include the following: synchronizing flushing and catheter or probe pullback status in imaging (e.g., OCT imaging); reducing or minimizing medical specialist tasks during intravascular imaging; reducing or minimizing pullback imaging loss due to late or early pullback triggering; and preventing the use of or avoiding a second flush, thereby reducing or minimizing risks to the patient.

[0097] One or more methods of the present disclosure are used to apply (one or more) automatic pullback methods using in vivo animal data. One or more of the (one or more) automatic pullback methods can be used with one or more imaging modalities, such as but not limited to MM-OCT, NIRAF, IV-OCT, etc. In one or more embodiments, the MM-OCT catheter or probe used includes a dual-mode, fiber optic, intravascular imaging catheter or probe. MATLAB is used to perform calculations and / or process one or more functions of the (one or more) automatic pullback methods.

[0098] While the present invention has been described with reference to exemplary embodiments, it should be understood that the invention is not limited to the disclosed exemplary embodiments. The scope of the claims is to be accorded the broadest interpretation so as to encompass all modifications, equivalent structures, and functions.

[0099] Additional details and automated pullback experiments performed:

[0100] At least one objective of these experimental / report sections is to present at least one automated pullback algorithm, test at least one algorithm using retrospective experimental data, and interpret the results. The algorithm reduces the tasks of the expert during OCT imaging, reduces the likelihood of asynchronous washout pullback, and ensures that the entire target vessel will be imaged. Scope includes application of the automated pullback algorithm using in vivo animal data.

[0101] definition

[0102] Terms / Acronyms definition MMOCT Multimodal Optical Coherence Tomography NIRAF Near-infrared autofluorescence BIA Blood imaging area A-line image Optical coherence tomography image in polar coordinates

[0103] Dataset

[0104] At least one embodiment of the algorithm and / or method was tested against retrospective image data using two different ex vivo datasets generated during animal (pig) testing of the EP 1-3 (HORL-ENG-00250) and EP 2-1 (HORL-ENG-00665) systems. The data was acquired under the specific protocols described in HORL-RPT-00038 and HORL-RPT-00070 for studies using the EP 1-3 and EP 2-1 systems, respectively. 17 pullbacks, including pre-wash frames, were acquired and used to develop and test the current algorithm and / or method embodiments. Blood cleanout was performed using contrast media in most of the pullbacks (saline was used in one pullback), injection was either manual or automated, and two different catheters or probes were used in each system. A summary of the MMOCT pullbacks used in the experiments is provided in Fig.13 Presented in detail.

[0105] result

[0106] Gold Standard or Ground Truth

[0107] Two experts 1 and 2, one of whom was the inventor, independently reviewed the current dataset and detected clear frames in each pullback. A clear frame was defined as a frame showing at least three-quarters (270°) of the vessel wall structure. To define the inter-observer variability acceptance limit, the time delay between experts during the manual pullback was taken into account. During the manual pullback procedure, there may be disagreements / delays between experts in pressing the pullback button, which is acceptable around 0.5 seconds. The pullback was 400 frames and lasted for 2 seconds; therefore, 0.5 seconds equals 100 frames and was used as the variability acceptance limit. The difference between the results obtained by expert 1 and expert 2 (difference in number of frames and pullbacks) was Fig.14A (Inter-observer variability) is shown in .

[0108] Algorithm Evaluation Metrics

[0109] To evaluate the automatic pullback algorithm or method embodiments in the experiments, quantitative and qualitative measurements were used. The quantitative measurement included the frame difference between the algorithm or method and the expert: the frame clearing detected by the algorithm minus the frame clearing observed by the expert (mean). The results are presented in Fig. 14B =(difference between algorithm or method and two experts (mean)). Since the goal of the automatic pullback algorithm or method embodiment is to automatically start the pullback and all the pullback frames are in the clear state, a second qualitative evaluation measure is added: visual inspection of the longitudinal views (vertical and horizontal). The qualitative measure is used to: (i) perform the second checkpoint by visually inspecting whether all the algorithm or method's clear frame detections provide clear pullbacks, and (ii) evaluate the quality of the pullback.

[0110] Figures 15A-15B Two examples of qualitative evaluation are shown in , and the remaining examples are presented in Figures 16A-16Q (Qualitative results on longitudinal views). By visually inspecting the longitudinal views in two different directions (2D orthogonal sections), the difference in quality between the two pullbacks can be noticed: Pullback A is of better quality than Pullback B. Pullback A corresponds to Pullback #14 ( Fig.13 and Fig.16N ,in Figures 16A-16Q Pullback #1 to Pullback #17 are shown respectively. Fig.13 ), which is closely related to experts ( Fig. 14B ) has excellent consistency, while pullback B corresponds to pullback #2 ( Fig.13 and Fig. 16B ), which is similar to the expert ( Fig. 14B ) had moderate consistency. Regardless of the imaging quality, for one or more embodiments, both pullbacks passed the acceptance limit of 0.5 seconds (100 frames). At least two experimental examples of qualitative evaluation of at least one embodiment of the automatic pullback algorithm or method of the present disclosure were performed on two different pullbacks (Pullback A: Fig.13 and Fig.16N #14 shown in , and pulling back to B: Fig.13 and Fig. 16B The two different longitudinal views of the orthogonal section planes are visually inspected to check that (i) the vertical line 1500 is cleared in the detection frame (vertical line 1500 - see e.g. Fig.15A and 15B ) whether there is a clear state in the following frame; and (ii) the flushing quality. Fig.15A As shown in , the imaging quality is very good, and the algorithm or method embodiment successfully detects the clear frame with excellent consistency (algorithm frame 40 relative to expert frame 43). Fig. 15BAs shown in , the imaging quality is not suitable for guiding intervention, and the algorithm or method embodiment successfully detects clear frames with medium consistency (algorithm frame 372 relative to expert frame 334).

[0111] Time complexity

[0112] In order to obtain the time complexity of the algorithm or method used in the experiment, timers were set at the beginning and end of the algorithm or method. Fig.17 The time complexity of an automatic pull-back algorithm or method embodiment when applied to 2500 frames is presented. The average time to process a single frame is 0.029 seconds. The method(s) were implemented in Matlab and run on a laptop with the following features: AMD Ryzen PRO 2500U w / Radeon Vega Mobile Gfx 2.00GHz processor, 8.00GB RAM memory and 64-bit Windows 10 operating system.

[0113] Discussion of the experiment

[0114] The automatic pullback method or algorithm used in at least the experiments was designed to: process every frame during the full rotation of the MMOCT system, detect the cleared state of the vessel (bloodless vessel) during the contrast injection process, and automatically trigger the pullback.

[0115] Overall Performance

[0116] At least one algorithm or method is evaluated on pre-recording imaging data, and an expert's estimate of the first cleared frame is used as the "gold standard" or basis for comparison mentioned above. While the experimental data set (17 pullbacks) may be considered a small number to perform, the results suggest that the method or algorithm embodiments used for the experiments may be robust across a variety of quality pullbacks. A high-quality pullback is considered one in which the clearing state begins immediately and allows for clear imaging of the entire pullback (e.g., Fig.13 and Fig. 16C A low-quality pullback is considered one in which the clearing state takes time to occur, the vessel wall is not fully exposed, and the clearing state does not last for a long time (e.g., Fig.13 and Fig. 16B The algorithm or method used for the experiment managed to detect the first clear state frame in all 17 pullbacks and had excellent agreement with the expert's estimate in 15 pullbacks and in 2 pullbacks ( Fig.13 and Figures 16A-16B It should be noted that moderate consistency is found in pullbacks of low quality ( Fig.13 and Fig. 16BPullback #2 discussed or shown in ) or a pullback with a lot of noise (residual blood: Fig.13 and Fig.16A In the pullback #1) discussed or shown in.

[0117] Real-time applications

[0118] Because (one or more) algorithms or (one or more) method one or more embodiments can be applied in real time, so time performance is very important. Experimental results report that the algorithm or method used for experiment uses an average of 0.029 seconds to process images. Because the MMOCT system or equipment at full speed obtains 400 frames per 2 seconds, any algorithm or method embodiment designed for real-time application of the present disclosure can use an average processing speed of 0.005 seconds. The experimental implementation method of the algorithm or method embodiment implemented in Matlab can actually be processed once per 6 frames. But the final implementation method can be in C++, it can be at least ten times faster than Matlab, and should be able to cover or realize the real-time metric of 0.005 seconds per frame that can be used in one or more embodiments.

[0119] The OCT (e.g., IV-OCT, MM-OCT, etc.) system can be any system or device discussed herein, including but not limited to system 100, system 100', system 100", system 100'", etc. In fact, according to one or more features of the present disclosure, one or more of the devices or systems can be operated to perform one or more embodiments of the automatic pullback method or algorithm.

[0120] A computer (such as console or computer 1200, 1200') can be directed to any device and / or system being manufactured or used (including but not limited to device or system 100, device or system 100', device or system 100", device or system 100'", Figure 1-23 any embodiment shown in, any other device or system discussed herein, etc.) to perform any steps, processes and / or techniques discussed herein.

[0121] According to one or more additional aspects of the present disclosure, the desktop system may be used with techniques such as, but not limited to, the automated pullback techniques disclosed herein. Fig.18 An example of a system that can use the lumen distance calculation technique for benchtop use, such as for ophthalmic applications, is shown. Light from the light source 101 is passed through the deflection (or deflection) section 108 and split into the reference arm 102 and the sample arm 103. The reference beam passes through the length adjustment section 904 (optional in one or more embodiments) and is reflected from a reference mirror (such as Figure 1105), while the sample beam is reflected from a sample, target, patient (e.g., a patient's blood vessel), object 106, etc. in the sample arm 103 or scattered (e.g., via the PIU 110 and the catheter 120). In one embodiment, the two beams are combined at the deflection / deflection section 108 and an interference pattern is generated. In one or more embodiments, the beams enter the combiner 903, and the combiner 903 combines the two beams via the circulator 901 and the deflection section 108. The combined beam is preferably passed to one or more detectors (such as one or more detectors 107). A beam splitter (see, e.g., Figure 1 The output of the beam splitter 104 in the deflection section 108 and / or the interferometer is continuously acquired by one or more detectors (such as one or more detectors 107). The electrical analog signal is converted into a digital signal for use by a computer (such as, but not limited to, computer 1200 (see Figure 1 ; also discussed further below Figure 18-20 and 22), computer 1200' (see, for example, further discussed below Fig.23 Additionally or alternatively, one or more of the computers, CPUs, processors, etc. discussed herein may be used to process, control, update, emphasize, and / or change one or more of the multiple imaging modalities, and / or process related techniques, functions, or methods (e.g., (one or more) automatic pullback methods or (one or more) algorithms), or may process electrical signals, as discussed above.

[0122] In one or more embodiments, the sample arm 103 may include a phase shift unit 130 for use in (one or more) benchtop systems, such as Fig.19 The sample 106 may be located at the position of the mirror 105 used with the phase shift unit 130 (e.g., as shown in FIG. Figure 1 ). Light from the light source 101 is transmitted through the splitter 104 and split into the reference arm 102 and the sample arm 103. The reference beam passes through the length adjustment section 904 and is reflected by a reference mirror (such as Figure 18-20105), while the sample beam is reflected or scattered from the sample, target and / or object 106 by a phase shift unit (such as phase shift unit 130) in the sample arm 103. In one embodiment, the two beams are combined at the splitter 104 and an interference pattern is generated. In one or more embodiments, the beams enter the combiner 903, and the combiner 903 combines the two beams via the circulator 901 and the splitter 104, and the combined beam is passed to one or more detectors (such as one or more detectors 107). The output of the beam splitter 104 and / or the interferometer is continuously acquired by one or more detectors (such as one or more detectors 107). The electrical analog signal is converted into a digital signal so that it can be analyzed by a computer.

[0123] There are many ways to calculate rotation, intensity, lumen distance, or any other measurement discussed herein, to perform automated pullback method(s) or algorithm(s), and / or to control and / or manufacture digital and analog MMOCT devices / apparatuses, systems, and / or storage media. In at least one embodiment, a computer (such as console or computer 1200, 1200') may be dedicated to controlling and / or using OCT devices, systems, methods, and / or storage media for use with what is described herein.

[0124] According to one or more additional aspects of the present disclosure, one or more other systems may be used with the lumen distance calculation techniques disclosed herein. Fig. 20 An example of a system 100'' is shown that can use the automatic pullback technique for applications such as ophthalmology. Light from a light source 101 is passed through a deflection section 108 (e.g., a beam splitter or other deflecting or deflected section discussed herein) located within an OCT imaging engine 150 and split into a reference arm 102 and a sample arm 103. In one or more embodiments, the OCT imaging engine 150 can also include an OCT interferometer 151 (which can house or include the deflection section 108) and a swept source engine 152. The reference beam can be passed through a reference mirror (such as a reference reflector or reference reflector 105; also in FIG. 1 ). Figure 1 The sample beam is reflected or scattered from a sample, target or object 106 in the sample arm 103 while the reference reflector 105 in the reference arm 102 is reflected or scattered from the sample, target or object 106 in the sample arm 103. In one embodiment, the two beams are combined at the deflection section 108 and an interference pattern is generated. In one or more embodiments, the combined beam is passed to one or more detectors. The output of the interferometer 151 is continuously acquired by one or more detectors, such as one or more detectors 107. The electrical analog signal is converted into a digital signal for use with a computer, such as, but not limited to, computer 1200 (see, e.g. Figure 1 ; also discussed further below Figure 18-20 and 22), a computer 1200' (eg, see further discussion below). Fig.23 ) etc.) to analyze it. In one or more embodiments, the sample arm 103 includes a PIU 110 and a catheter 120, so that the sample beam is reflected or scattered from the sample, target or object 106, as discussed herein. In one or more embodiments, the PIU 110 may include one or more motors to control the pullback operation of the catheter 120 (or one or more components thereof) and / or control the rotation or spin of the catheter 120 (or one or more components thereof). For example, the PIU 110 may include a pullback motor (PM) and a spin motor (SM), and / or may include a motion control unit 112 that operates to perform pullback and / or rotation features using the pullback motor PM and / or the spin motor SM. As discussed herein, the PIU 110 may include a rotary joint (e.g., such as Fig.18 and 20 106). The rotary joint RJ can be connected to the spin motor SM so that the catheter 120 can obtain one or more views or images of the sample 106. The computer 1200 (or computer 1200') can be used to control one or more of the pullback motor PM, the spin motor SM and / or the motion control unit 112. The OCT system may include one or more of an OCT engine 150, a computer (e.g., computer 1200, computer 1200', etc.), a PIU 110, a catheter 120, a monitor, etc. One or more embodiments of the OCT system can interact with one or more external systems (such as, but not limited to, a vascular system, an external display, one or more hospital networks, an external storage medium, a power supply, a bedside controller (e.g., which can be connected to the OCT system using Bluetooth technology or other methods known for wireless communication), etc.).

[0125] Preferably, the deflection or deflected section 108 (in Figure 18-20In one or more embodiments (best seen in ), the deflected segment 108 operates to deflect light from the light source 101 to the reference arm 102 and / or the sample arm 103, and then sends the light received from the reference arm 102 and / or the sample arm 103 toward 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 segment (e.g., the deflected segment 108 of system 100, 100', 100", 100'", any other system discussed herein, etc.) may include or may contain one or more interferometers or optical interference systems that operate as described herein, including but not limited to circulators, beam splitters, isolators, couplers (e.g., fused fiber couplers), partially blocked mirrors with holes, partially blocked mirrors with taps, and the like. In one or more embodiments, the interferometer or optical interferometer system may include one or more components of the system 100 (or any other system discussed herein), such as, but not limited to, one or more of the light source 101, the deflected segment 108, the rotary joint RJ, the PIU 110, the catheter 120, etc. Figure 1-23 One or more features of the above-mentioned configurations may be incorporated into one or more systems, including but not limited to the systems 100, 100', 100", 100'" discussed herein.

[0126] Although not limited to such arrangements, configurations, devices, or systems, one or more embodiments of the devices, apparatuses, systems, methods, storage media, GUIs, etc. discussed herein may be used in conjunction with the above-mentioned apparatuses or systems (such as, but not limited to, for example, system 100, system 100', system 100", system 100'". Figure 1-23 In one or more embodiments, a user may perform the method(s) discussed herein. In one or more embodiments, one or more users may perform the method(s) discussed herein. In one or more embodiments, one or more of the computers, CPUs, processors, etc. discussed herein may be used to process, control, update, emphasize, and / or change one or more of a variety of imaging modalities to calculate lumen distance(s), perform automatic pullback methods(s) or algorithms(s), and / or process related techniques, functions, or methods, or may process electrical signals as discussed above.

[0127] The light source 101 may include multiple light sources or may be a single light source. The light source 101 may be a broadband light source and may include one or more of a laser, an organic light emitting diode (OLED), a light emitting diode (LED), a halogen lamp, an incandescent lamp, a supercontinuum light source pumped by a laser, and / or a fluorescent lamp. The light source 101 may be any light source that provides light that may then be dispersed to provide light that is subsequently used for imaging, performing control, viewing, changing, emphasizing methods for one or more imaging modalities, and / or any other methods discussed herein. The light source 101 may be fiber coupled or may be free space coupled to the device and / or system 100, 100', 100", 100'", Figure 1-23 The device, apparatus or system of or other components of any other embodiment discussed herein. As mentioned above, the light source 101 can be a swept source (SS) light source.

[0128] Additionally or alternatively, the one or more detectors 107 may be a linear array, a charge coupled device (CCD), a plurality of photodiodes, or some other method of converting light into an electrical signal. The detector(s) 107 may include an analog-to-digital converter (ADC). The one or more detectors may be a device having a plurality of photodiodes, such as a laser diode, ... Figure 1-23 A detector having one or more of the structures shown and discussed above.

[0129] The one or more detectors 107 may transmit digital or analog signals to a processor or computer, such as, but not limited to, an image processor, a processor or computer 1200, 1200' (see, e.g. Figure 1 , 18 -20 and 22-23), combinations thereof, and the like. The image processor may be a dedicated image processor or a general purpose processor configured to process images. In at least one embodiment, a computer 1200, 1200' 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 one or more detectors 107. The image processor may include one or more of a CPU, a DSP, an FPGA, an ASIC, or some other processing circuit system. The image processor may include a 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. The computers or processors discussed herein (such as but not limited to Figure 1-23 The processor of the device, apparatus or system, computer 1200, computer 1200', image processor) may also include one or more components discussed further below (see, for example, Figure 22-23 ).

[0130] In at least one embodiment, the console or computer 1200, 1200' operates to control the movement of RJ via a motion control unit (MCU) 112 or motor M, acquire intensity data from (one or more) of the one or more detectors 107, and display the scanned image (e.g., on a monitor or screen, such as Figure 18-20 and Fig. 22 Any of the consoles or computers 1200 and / or as further discussed below Fig.23 In one or more embodiments, the MCU 112 or the motor M is operated to change the motor of the RJ and / or the speed of the RJ. The motor can be a stepper or DC servo motor to control the speed and improve the position accuracy (e.g., compared to when no motor is used, compared to when no automatic or controlled speed and / or position change device is used, compared to manual control, etc.).

[0131] The output of one or more components of any of the systems discussed herein may be acquired using at least one detector 107 (e.g., such as, but not limited to, a photodiode, (one or more) photomultiplier tubes (PMTs), (one or more) line scan cameras, or (one or more) multi-array cameras). Figure 1-23 The electrical analog signal obtained from the output of the device, apparatus or system is converted into a digital signal for analysis by a computer (such as but not limited to computer 1200, 1200'). In one or more embodiments, the light source 101 can be a radiation source or a broadband light source radiating over a wide wavelength band. In one or more embodiments, a Fourier analyzer including software and electronic devices can be used to convert the electrical analog signal into a spectrum.

[0132] Unless otherwise discussed herein, like numbers refer to like elements. For example, although systems / devices (such as, but not limited to, system 100, system 100', system 100", system 100'", Figure 1-23There may be variations or differences between the systems / devices, etc.) (e.g., differences between the positions of (one or more) of the reference reflector 105 (and / or the reference arm 102), which depends on the OCT system or method used), but one or more features thereof may be the same or similar to each other, such as, but not limited to, the light source 101, the deflection section 108, or (one or more) other components thereof (e.g., the console 1200, the console 1200', etc.). Those skilled in the art will recognize that the light source 101, the at least one detector 107, and / or one or more other elements of the system 100 may operate in the same or similar manner as those like numbered elements of one or more other systems (such as, but not limited to, the system 100', the system 100", the system 100'", etc.), as discussed herein. Those skilled in the art will recognize that the system 100, the system 100', the system 100", the system 100'", etc. Figure 1-23 Alternative embodiments of the systems / apparatuses and / or one or more like-numbered elements of one of such systems, while having other variations as discussed herein, may operate in the same or similar manner as like-numbered elements of any other system (or its component(s)) discussed herein. Indeed, although in system 100, system 100', system 100" and system 100"', Figure 1-23 There are certain differences between the systems / devices, any other embodiments, etc., as discussed herein, but there are similarities between the devices / systems discussed herein. Likewise, while the console or computer 1200 may be used in one or more systems (e.g., system 100, system 100', system 100", system 100'", Figure 1-23 , but one or more other consoles or computers (such as console or computer 1200') may additionally or alternatively be used.

[0133] According to one or more aspects of the present disclosure, one or more methods for detecting and directing optical connections are provided herein, and one or more methods for performing imaging are provided herein. Fig.21 A flow chart of at least one embodiment of a method for performing imaging is illustrated. Preferably, the method(s) may include one or more of the following: (i) splitting or dividing the light into a first light and a second reference light (see Fig.21 (ii) receiving reflected or scattered light of the first light after the first light travels along the sample arm and illuminates the object or sample (see Fig.21 (iii) receiving a second reference light after the second reference light travels along the reference arm and is reflected from the reference reflector (see step S4001 in FIG. 4 ); Fig.21(iv) generating interference light by causing the reflected or scattered light of the first light and the reflected second reference light to interfere with each other (e.g., by combining or recombining and then interfering, by interference, etc.), the interference light generating one or more interference patterns (see Fig.21 One or more methods may also include using a low frequency monitor to update or control high frequency splitting to improve image quality. For example, one or more embodiments may use balanced detection, polarization diversity, automated polarization control, (one or more) calculated lumen distances, (one or more) automatic pullback methods or (one or more) algorithms, etc. to achieve improved image quality. In one or more embodiments, the imaging probe may be connected to one or more systems (e.g., system 100, system 100', system 100", system 100'", system 100'", etc.) using a connecting member or interface module. Figure 1-23 , devices, apparatuses or systems, any other systems or apparatuses discussed herein, etc.). For example, when the connecting member or interface module is a rotary joint for an imaging probe, 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 joints known to those skilled in the art. The rotary joint may be a single-channel rotary joint or a dual-channel rotary joint. In one or more embodiments, the illumination portion of the imaging probe may be separated from the detection portion of the imaging probe. For example, in one or more applications, the probe may refer to an illumination assembly, which includes an illumination fiber (e.g., a single-mode fiber, a GRIN lens, a spacer, and a grating on a polished surface of the spacer, etc.). In one or more embodiments, the scope may refer to an illumination portion, which may be surrounded and protected, for example, by a drive cable, a sheath, and a detection fiber (e.g., a multimode fiber (MMF)) surrounding the sheath. For one or more applications, the grating covering on the detection fiber (e.g., MMF) is optional. The illumination portion may be connected to the rotary joint and may be continuously rotated at video rates. In one or more embodiments, the detection portion may include one or more of the following: a detection fiber, a detector (e.g., one or more detectors 107, a spectrometer, etc.), a computer 1200, a computer 1200', etc. The detection fiber may surround the illumination fiber, and the detection fiber may or may not be covered by a grating, a spacer, a lens, the end of a probe or catheter, etc.

[0134] There are many ways to calculate power and / or detect lumen edge(s) and artifact(s), and / or perform automatic pullback method(s) or algorithm(s), both digital and analog. In at least one embodiment, a computer (such as console or computer 1200, 1200') can be dedicated to the control and monitoring of the OCT devices, systems, methods, and / or storage media described herein.

[0135] The electrical signals for imaging may be transmitted via cable(s) or wire(s) such as, but not limited to, cable(s) or wire(s) 113 (see Fig. 22 )) is sent to one or more processors (such as, but not limited to, computer 1200 (see, e.g., Figure 1 , 18 -20 and 22), computer 1200' (see e.g. Fig.23 ) etc.). Additionally or alternatively, the computers or processors discussed herein are interchangeable and may be operated to perform any of the feature(s) and method(s) discussed herein.

[0136] Computer system 1200 (see, e.g. Figure 1 and 18 -20) are shown in the various components of the console or computer 1200 Fig. 22 The computer system 1200 may include a central processing unit ("CPU") 1201, a ROM 1202, a RAM 1203, a communication interface 1205, a hard disk (and / or other storage device) 1204, a screen (or a monitor interface) 1209, a keyboard (or an input interface; in addition to the keyboard, a mouse or other input device may also be included) 1210, and buses or other connecting lines (e.g., connecting lines 1213) between one or more of the above-mentioned components (e.g., as shown in FIG. 1 ). Fig. 22 ). In addition, the computer system 1200 may include one or more of the components mentioned above. For example, the computer system 1200 may include a CPU 1201, a RAM 1203, an input / output (I / O) interface (such as a communication interface 1205), and a bus (which may include one or more lines 1213 as a communication system between the components of the computer system 1200; in one or more embodiments, the computer system 1200 and at least its CPU 1201 may communicate with a FORJ or a device or system using a FORJ (such as, but not limited to, the system 100, system 100', system 100", system 100'" and / or system 100'" discussed above) via one or more lines 1213. Figure 1-23The computer system 1200 may communicate with one or more of the above-mentioned components of the system / device of the present invention, and one or more other computer systems 1200 may include one or more combinations of the other above-mentioned components (for example, one or more lines 1213 of the computer 1200 may be connected to other components via line 113). CPU 1201 is configured to read and execute computer executable instructions stored in a storage medium. Computer executable instructions may include those instructions for performing the methods and / or calculations described herein. In addition to CPU 1201, the computer system 1200 may also include one or more additional processors, and such processors including CPU 1201 may be used to control and / or manufacture devices, systems or storage media for use therewith or with any lumen detection, (one or more) stent detection, (one or more) artifact detection and / or (one or more) lumen distance calculation technology, and / or with (one or more) automatic pullback techniques discussed herein. The system 1200 may also include one or more processors connected via a network connection (for example, via network 1206). CPU 1201 and any additional processors used by system 1200 may be located in the same telecommunications network or in different telecommunications networks (eg, the execution, manufacturing, control, computing and / or use of the technology(s) may be controlled remotely).

[0137] I / O or communication interface 1205 provides a communication interface to input and output devices, which may include light source 101, RJ, PM, SM, unit 150, unit 112, microphone, communication cables and networks (either wired or wireless), keyboard 1210, mouse (see e.g. Fig.23 The communication interface of the computer 1200 can be via line 113 (such as a mouse 1211 shown in FIG. 1 ), a touch screen or screen 1209, a light pen, etc. Fig. 22 1204 is connected to the other components discussed herein. A monitor interface or screen 1209 provides a communication interface therefor.

[0138] Any of the methods and / or data of the present disclosure (such as, but not limited to, methods for using and / or manufacturing devices, systems or storage media for use therewith, and / or for imaging, performing tissue or sample characterization or analysis, performing diagnosis, planning and / or inspection, detecting (one or more) lumen edges, (one or more) stents and / or (one or more) artifacts (including in (one or more) OCT images) and / or for performing (one or more) automatic pullback techniques as discussed herein) can be stored on a computer-readable storage medium. Commonly used computer-readable and / or writable storage media (such as, but not limited to, hard disks (e.g., hard disk 1204, magnetic disks, etc.), flash memory, CDs, optical disks (e.g., compact disks ("CD"), digital versatile disks ("DVD"), Blu-ray disks), TM disks, etc.), magneto-optical disks, random access memories ("RAM") (such as RAM 1203), DRAM, read-only memories ("ROM"), storage devices of distributed computing systems, memory cards, etc. (e.g., other semiconductor memories, such as but not limited to non-volatile memory cards, solid-state drives (SSDs) (see Fig.23 One or more of the SSD 1207 in the computer system 1200), SRAM, etc.), their optional combinations, servers / databases, etc.) can be used to cause a processor (such as the processor or CPU 1201 of the computer system 1200 mentioned above) to perform the steps of the method disclosed herein. In one or more embodiments, the computer-readable storage medium may be a non-transitory computer-readable medium, and / or the computer-readable medium may include all computer-readable media, with the only exception of transient propagation signals. The computer-readable storage medium may include a medium that stores information for (one or more) predetermined, limited or short time periods and / or only when there is power, such as but not limited to random access memory (RAM), register memory, (one or more) processor caches, etc. The (one or more) embodiments of the present disclosure may also be implemented 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 also be more comprehensively referred to as a "non-transitory computer-readable storage medium") to perform one or more of the above-mentioned (one or more) embodiments and / or includes one or more circuits (e.g., an application-specific integrated circuit (ASIC)) for performing the functions of one or more of the above-mentioned (one or more) embodiments, as well as by a method of executing the functions of one or more of the above-mentioned (one or more) embodiments by a computer of the system or device, for example, reading out and executing computer-executable instructions from a storage medium to perform one or more of the above-mentioned (one or more) embodiments and / or controlling one or more circuits to perform one or more of the above-mentioned (one or more) embodiments.

[0139] According to at least one aspect of the present disclosure, methods, devices, systems, and computer-readable storage media related to a processor (such as but not limited to the processor of the computer 1200 mentioned above, the processor of the computer 1200', etc., as described above) can be implemented using appropriate hardware, such as shown in the accompanying drawings. The functions of one or more aspects of the present disclosure can be implemented using appropriate hardware, such as Fig. 22 Such hardware may be implemented using any known technology, such as standard digital circuit systems, any known processor operable to execute software and / or firmware programs, one or more programmable digital devices or systems, such as programmable read-only memory (PROM), programmable array logic (PAL), etc. CPU1201 (such as Fig. 22 or Fig.23 ) may also include and / or consist of one or more microprocessors, nanoprocessors, one or more graphics processing units ("GPUs"; also called visual processing units ("VPUs")), one or more field programmable gate arrays ("FPGAs"), or other types of processing components (e.g., (one or more) application-specific integrated circuits (ASICs)). Further, various aspects of the present disclosure may be implemented by software and / or firmware programs that may be stored on a suitable storage medium (e.g., a computer-readable storage medium, a hard drive, etc.) or a medium for transport and / or distribution (such as (one or more) floppy disks, (one or more) memory chips, etc.). The computer may include a network of independent computers or independent processors to read out and execute computer-executable instructions. Computer-executable instructions may be provided to the computer, for example, from a network or storage medium. A computer or processor (e.g., 2, 1200, 1200', etc.) may include the CPU structure mentioned above, or may be connected to such a CPU structure to communicate with it.

[0140] As mentioned above, the hardware structure of an alternative embodiment of the computer or console 1200' is Fig.23 The computer 1200' includes a central processing unit (CPU) 1201, a graphics processing unit (GPU) 1215, a random access memory (RAM) 1203, a network interface device 1212, an operation interface 1214 (such as a universal serial bus (USB)) and a memory (such as a hard disk drive or a solid state drive (SSD) 1207). Preferably, the computer or console 1200' includes a display 1209. The computer 1200' can be connected to a rotary joint (for example, Fig.18 RJ Fig. 20 RJ, etc.), motor PM, motor SM and / or system (e.g., system 100, system 100', system 100", system 100'", Figure 1-23The CPU 1201 or the GPU 1215 may be connected to one or more other components of a system / device, etc.). In one or more embodiments, a computer (such as computer 1200, 1200') may include an RJ, a PM, and / or an SM. An 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 the 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 (such as computer 1200, computer 1200', etc.).

[0141] At least one computer program is stored in SSD 1207, and CPU 1201 loads at least one program onto RAM 1203 and executes instructions in at least one program to perform one or more processes described herein, as well as basic input, output, calculation, memory write, and memory read processes.

[0142] A computer (such as computer 1200, 1200') communicates with the PIU 110, a rotary joint (e.g., RJ, etc.), a motor PM, a motor SM, an MCU 112, a catheter 120, and / or one or more other components of the system (such as system 100, 100', 100", 100'", etc.) to perform imaging and reconstruct an image from the acquired intensity data. A monitor or display 1209 displays the reconstructed image and may display other information about the imaging conditions or about the object to be imaged. Monitor 1209 also provides a graphical user interface for a user to operate the system (e.g., system 100, system 100', system 100", system 100'", etc.), for example when performing OCT or other imaging techniques, including but not limited to detection of (one or more) lumen edges and / or (one or more) artifacts, and / or performing (one or more) automatic pullback techniques. The operation signal is input from the operation unit (e.g., such as but not limited to the mouse device 1211, the keyboard 1210, the touch panel device, etc.) to the operation interface 1214 in the computer 1200', and corresponding to the operation signal, the computer 1200' instructs the system (e.g., the system 100, the system 100', the system 100", the system 100'", Figure 1-23 The laser source 101 of the OCT system mentioned above may have an interface for communicating with the computer 1200, 1200' to send and receive status information and control signals.

[0143] Similarly, one or more components of the present disclosure and / or devices, systems, and storage media and / or methods thereof may also be used in conjunction with an optical coherence tomography probe.

[0144] Such probes include, but are not limited to, 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; and U.S. Patent Publication Nos. 2014 / 0276011 and 2017 / 0135584; and WO 2014 / 0276011 to Tearney et al. OCT imaging systems disclosed in 2016 / 015052, and arrangements and methods for facilitating photoluminescent imaging, such as those disclosed in U.S. Patent No. 7,889,348 to Tearney et al., and disclosures for multimodal imaging disclosed in U.S. Patent Nos. 9,332,942 and 2010 / 0092389, 2011 / 0292400, 2012 / 0101374, 2016 / 0228097, 2018 / 0045501, and 2018 / 0003481, each of which is incorporated herein by reference in its entirety. As mentioned above, any features or aspects of the present disclosure may be used with the features disclosed in WO 2016 / 144878, which is incorporated herein by reference in its entirety. As mentioned above, any features or aspects of the present disclosure may be used with OCT imaging systems, devices, methods, storage media, or other aspects or features as discussed in U.S. Patent Publication 2019 / 0298174; U.S. Patent Application No. 16 / 131,662; U.S. Patent Application No. 16 / 414,222 filed on May 16, 2019; U.S. Patent Application No. 62 / 901,472; U.S. Patent Application No. 62 / 925,655; and U.S. Patent Application No. 62 / 944,064 filed on December 5, 2019, each of which patent(s), publication(s), and application(s) are incorporated herein by reference in their entirety.

[0145] Although the present disclosure has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure (and are not limited thereto), and the present invention is not limited to the disclosed embodiments. It should therefore be understood that various modifications may be made to the illustrative embodiments and other arrangements may be designed without departing from the spirit and scope of the present disclosure. The scope of the appended claims should be given the broadest interpretation to cover all such modifications, equivalent structures and functions.

Claims

1. An imaging device for triggering automatic retraction, the device comprising: Imaging probes; as well as One or more processors that: (a) Import multiple A-lines or one or more images; (b) Initialize the counter; (c) segmenting the A-line or image; (d) dividing the segmented A-line or image into three or more equal parts; (e) defining a blood imaging area (BIA), which is the area surrounding the imaging probe in the presence of blood; (f) detecting a number of objects that do not overlap with the BIA or are more than a predetermined distance away from the imaging probe in a current frame of one or more frames of the segmented A-line or image; (g) Perform the counting step: In the event that the number of objects is greater than or equal to N, where N is the minimum accepted number of objects defining a partially cleared or cleared state, incrementing a counter by a set or predetermined amount or by 1, and In the event that the number of objects is less than N, setting the counter to 0 and repeating steps (c)-(g) for another frame or subsequent frames in the plurality of frames; and (h) triggering a pullback if the counter is X or greater, where X is a predetermined value, or if the one or more processors have incremented the counter and the counter is less than X, repeating steps (c)-(g) for a next frame in the plurality of frames.

2. The apparatus of claim 1 , wherein the one or more processors are further operative to perform one of: (i) preparing the plurality of A-lines or the one or more images by removing the imaging probe and extravascular noise from the current frame or image or otherwise performing frame or image processing or preprocessing, and setting a counter to zero; (ii) performing frame or image processing or preprocessing on the A-line or image by removing one or more of the imaging probe and / or extravascular noise from the current frame or image; (iii) segmenting the A-line, the frame or current frame, or the image using automatic thresholding, and when segmenting the A-line or the image into three or more equal parts, segmenting the A-line, the frame or current frame, or the image into four equal parts corresponding to four Cartesian quadrants; (iv) deleting any detected objects of a predetermined size and counting how many objects are more than a predetermined distance from the imaging probe or how many objects overlap the BIA; (v) deleting any detected objects of a predetermined size and counting how many objects are more than a predetermined distance from the imaging probe or how many objects overlap the BIA, and in the event that at least three (3) objects are detected as being more than the imaging probe distance being the predetermined distance or not overlapping the BIA, performing the counting step by incrementing the counter to one or by one, or in the event that at least three (3) objects are detected as being more than the imaging probe distance or overlapping the BIA, again setting the counter to zero and moving to the next frame or image, so that the one or more processors operate to repeat steps (c)-(g); and / or (vi) if the counter is not yet equal to or greater than the predetermined value X, move to the next A-line frame or image and repeat steps (a) and steps (c)-(g), or if the counter is equal to or greater than the predetermined value X, trigger the automatic retraction of the catheter or probe of the imaging device via step (h) by ending the signal, by using the signal, or by generating or sending the signal.

3. The apparatus of claim 2, wherein one of the following: (i) the object of the predetermined size is at least one of: a small object; and / or an object corresponding to noise, residual blood and / or other artifacts; (ii) the one or more processors are further operative to delete any detected objects of a predetermined size and count how many objects are more than a predetermined distance from the imaging probe or count how many objects overlap the BIA, wherein the predetermined distance from the imaging probe is defined as an imaging probe distance, and the one or more processors are further operative to compare the object with the imaging probe distance value to determine whether the object is blood; (iii) the one or more processors are further operable to delete any detected objects of a predetermined size and count how many objects are more than a predetermined distance from the imaging probe or count how many objects overlap with the BIA, and / or in order to define the imaging probe distance, the one or more processors are further operable to measure the imaging depth at different blood state images or frames and average the measurement results; and / or (iv) The predetermined distance is defined by using an image in which blood is present.

4. The apparatus of claim 1, wherein one of the following: (i) the one or more processors are further operative to calculate a relative position of the object and the imaging probe; (ii) the one or more processors are further operable to calculate a relative position of the object and the imaging probe, and / or the one or more processors are further operable to omit calculating the relative position of the object and the imaging probe; (iii) in the case where the one or more processors use the BIA, the BIA is represented as an area that is more than a predetermined distance from the tip of the imaging probe, or a circular area above the tip of the imaging probe is represented as the BIA; (iv) the BIA is defined or predefined using images in which blood is present; and / or (v) The number of pixels that are more than a predetermined height away from the imaging probe tip is indicated.

5. The apparatus of claim 1, wherein one of the following: (i) importing the plurality of A-lines or the one or more images in a scanning mode, wherein the imaging probe is a full-speed spinning imaging probe; (ii) the predetermined value X for the counter is at least one of: 1, 2, 3, 4, 5, 6, or greater than 6, and / or is determined by a clinician based on how much time is needed for a procedure or imaging pullback and based on how long a clear state lasts; (iii) the one or more processors are further operative to detect how much the subject moves during blood imaging for optical coherence tomography (OCT); (iv) the one or more processors are further operative to determine or evaluate a clear condition of a processed frame, A-line, or image; (v) importing the plurality of A-lines or the one or more images in a scanning mode, wherein the imaging probe is a full-speed spinning imaging probe, and when the number of objects that are more than a predetermined distance from the imaging probe is equal to or greater than a predetermined threshold, the one or more processors determine that a blood vessel wall or a target in the image or frame is visible in the current image or frame; and / or (vi) importing the plurality of A-lines or the one or more images in a scanning mode, wherein the imaging probe is a full-speed spinning imaging probe, and when the number of objects that are more than a predetermined distance from the imaging probe is equal to or greater than a predetermined threshold, the one or more processors determine that a blood vessel wall or a target in the image or frame is visible in the current image or frame, and the predetermined threshold is one or more of the following: 2 or more, 3 or more, 4 or more, 5 or more, and / or a predetermined number or more, wherein the predetermined number is set by a user of the device or automatically set by the device.

6. The apparatus of claim 1, wherein one of the following: (i) the one or more processors are further operative to control the device to flush the imaging probe to remove the presence of blood; (ii) the one or more processors are further operative to control the device to flush the imaging probe to remove the presence of blood, and the one or more processors are further operative to ensure that the flushing and the automatic pullback are synchronized; (iii) the one or more processors are further operative to reduce, consolidate and / or minimize one or more tasks of a user of the device during a catheter insertion or imaging probe procedure such that the user's work is also reduced, minimized and / or more efficient; (iv) the one or more processors are further operative to reduce, consolidate and / or minimize one or more tasks of a user of the device during a catheter insertion or imaging probe procedure such that the user's work is also reduced, minimized and / or more efficient, and the user's tasks involve one or more of: controlling live mode speed, pressing a button to control live mode speed, controlling scan mode speed, pressing a button to control scan mode speed, causing flushing to occur, pressing a button to cause flushing to occur, causing pullback to occur, and / or pressing a button to cause pullback to occur; and / or (v) The one or more processors are further operative to trigger automatic retraction of the catheter or probe of the imaging device without any user interaction.

7. The apparatus of claim 1, wherein one of the following: (i) A lines, frames or images are defined by blocks or collections of A lines and when transformed to Cartesian coordinates form a two-dimensional (2D) optical coherence tomography (OCT) image or frame; (ii) during image or frame processing or pre-processing, pixels corresponding to the imaging probe, artifacts and / or extravascular tissue regions are set to zero by the one or more processors and filtering is applied by the one or more processors; (iii) during image or frame processing or pre-processing, pixels corresponding to the imaging probe, artifacts and / or extravascular tissue regions are set to zero by the one or more processors, and filtering is applied by the one or more processors, and the filtering is a mean filter, a spatial filter and / or a sliding window or kernel spatial filter, which replaces the center value of the window with the mean intensity value of the pixels belonging to the window, and for image I and a window of size NxN, the value of the center pixel (i, j) of the window is replaced by Replace, where m, n are the pixels belonging to the window NxN; and / or (iv) during image or frame processing or pre-processing, pixels corresponding to the imaging probe, artifacts and / or extravascular tissue regions are set to zero by the one or more processors, and the one or more processors apply filtering, and the filtering is Gaussian filtering or bilateral filtering, and / or the one or more processors also operate to use convolution to replace the intensity of the center pixel of the mask with a weighted average of the intensities of neighboring pixels.

8. The apparatus of claim 1, wherein one of the following: (i) the one or more processors are further operative to apply image or frame segmentation by (a) applying automatic thresholding to the A-line, image, or frame, (b) smoothing the segmented A-line, image, or frame by removing objects of a predetermined or set size corresponding to image or frame artifacts, and (c) dividing the A-line, image, or frame into three or more equal parts; (ii) the one or more processors are further operative to apply image or frame segmentation by (a) applying automatic thresholding to the A-line, image or frame, (b) smoothing the segmented A-line, image or frame by removing objects of a predetermined or set size corresponding to image or frame artifacts, and (c) dividing the A-line, image or frame into three or more equal parts, and the automatic thresholding is Otsu thresholding; (iii) the one or more processors are further operative to apply image or frame segmentation by (a) applying automatic thresholding to the A-line, image or frame, (b) smoothing the segmented A-line, image or frame by removing objects of a predetermined or set size corresponding to image or frame artifacts, and (c) dividing the A-line, image or frame into three or more equal parts, and the automatic thresholding is Otsu thresholding, using the Otsu method to calculate a threshold value Thr of the image I otsu , and will be less than Thr otsu setting pixels of an image I corresponding to an A-line, image or frame to zero values ​​so as to generate a binary image having an arterial wall and blood represented by non-zero objects; (iv) in order to determine whether a non-zero object corresponding to an image or frame artifact exists and in order to remove the non-zero object corresponding to the image or frame artifact from the set of non-zero objects to be used for detecting boundaries, the one or more processors are further operative to detect objects smaller than a predetermined area to ensure that only objects remaining in the set correspond to wall areas and are used for detecting boundaries; (v) in order to determine whether a non-zero object corresponding to an image or frame artifact exists and to remove the non-zero object corresponding to the image or frame artifact from the set of non-zero objects to be used for detecting a boundary, the one or more processors are further operative to detect objects smaller than a predetermined area to ensure that only objects remaining in the set correspond to the wall area and are used for detecting the boundary, and the predetermined area is the entire catheter area or the probe area, or 3% of the entire image or frame; and / or (vi) The one or more processors are further operative to detect larger objects and delete objects that are smaller than the larger objects by a predetermined percentage, wherein the predetermined percentage is any value in the range of 10% to 50%.

9. The apparatus of claim 8, wherein the predetermined percentage is any value in the range of 20% to 30%.

10. The apparatus of claim 9, wherein the predetermined percentage is one or more of: 24%, 20%, 25%, 30%.

11. The apparatus of claim 1, wherein one of the following: (i) the one or more processors are further operative to determine whether the target or arterial wall is visible for a predetermined number of consecutive frames or images; (ii) the one or more processors are further operative to determine whether the target or arterial wall is visible for a predetermined number of consecutive frames or images, and the predetermined number of consecutive frames or images is one or more of: three, four, five and / or six; (iii) the one or more processors are further operative to determine, for a predetermined number of consecutive frames or images, whether the target or arterial wall is visible, and in the event that the target or arterial wall is visible, the one or more processors trigger automatic pullback; (iv) the counter operates to ensure that blood is sufficiently cleared so that automatic pullback is synchronized with improved or optimal clearance conditions; (v) each time a clear condition is detected, the counter is incremented; and / or (vi) The one or more processors are further operable to determine whether the target or arterial wall is visible for a predetermined number of consecutive frames or images, and the one or more processors are further operable to detect whether the number of objects that do not overlap with the BIA is greater than a predetermined threshold, such that it is determined that the target or arterial wall is revealed or visible and the blood is flushed to indicate a clear state, wherein the predetermined threshold is three or more.

12. A control method for triggering automatic retraction of an imaging device, the imaging device having an imaging probe, the control method comprising: (a) Import multiple A-lines or one or more images; (b) Initialize the counter; (c) segmenting the A-line or image; (d) dividing the segmented A-line or image into three or more equal parts; (e) defining a blood imaging area (BIA), which is the area surrounding the imaging probe in the presence of blood; (f) detecting a number of objects that do not overlap with the BIA or are more than a predetermined distance away from the imaging probe in a current frame of one or more frames of the segmented A-line or image; (g) Perform the counting step: In the event that the number of objects is greater than or equal to N, where N is the minimum accepted number of objects defining a partially cleared or cleared state, incrementing a counter by a set or predetermined amount or by 1, and In case the number of objects is less than N, setting the counter to 0 and repeating steps (c)-(g) for another frame or a subsequent frame in the plurality of frames; and (h) triggering a pullback when the counter is X or greater, where X is a predetermined value, or when the counter has been incremented and the counter is less than X, repeating steps (c)-(g) for the next frame in the plurality of frames.

13. The control method according to claim 12, further comprising one of the following: (i) preparing the plurality of A-lines or the one or more images by removing the imaging probe and extravascular noise from the current frame or image or otherwise performing frame or image processing or preprocessing, and setting a counter to zero; (ii) performing frame or image processing or preprocessing on the A-line or image by removing one or more of the imaging probe and / or extravascular noise from the current frame or image; (iii) segmenting the A-line, the frame or current frame, or the image using automatic thresholding, and when segmenting the A-line or the image into three or more equal parts, segmenting the A-line, the frame or current frame, or the image into four equal parts corresponding to four Cartesian quadrants; (iv) deleting any detected objects of a predetermined size and counting how many objects are more than a predetermined distance from the imaging probe or how many objects overlap the BIA; (v) deleting any detected objects of a predetermined size and counting how many objects are more than a predetermined distance from the imaging probe or how many objects overlap the BIA, and if at least three (3) objects are detected as being more than a predetermined distance from the imaging probe or not overlapping the BIA, performing the counting step by increasing the counter to one or by one, or if at least three (3) objects are not detected as being more than the imaging probe distance or overlapping the BIA, again setting the counter to zero and moving to the next frame or image, so as to repeat steps (c)-(g); and / or (vi) if the counter is not yet equal to or greater than the predetermined value X, move to the next A-line frame or image and repeat steps (a) and steps (c)-(g), or if the counter is equal to or greater than the predetermined value X, trigger the automatic retraction of the catheter or probe of the imaging device via step (h) by ending the signal, by using the signal, or by generating or sending the signal.

14. The control method of claim 13, wherein one of the following: (i) the control method further includes deleting any detected objects of a predetermined size and counting how many objects are more than a predetermined distance from the imaging probe or how many objects overlap the BIA, and the objects of the predetermined size are at least one of: small objects; and / or objects corresponding to noise, residual blood and / or other artifacts; (ii) the control method further includes deleting any detected objects of a predetermined size and counting how many objects are more than a predetermined distance from the imaging probe or counting how many objects overlap the BIA, and the predetermined distance from the imaging probe is defined as an imaging probe distance, and the control method further includes comparing the object with the imaging probe distance value to determine whether the object is blood; (iii) the control method further includes deleting any detected objects of a predetermined size and counting how many objects are more than a predetermined distance from the imaging probe or counting how many objects overlap the BIA, and / or in order to define the imaging probe distance as the predetermined distance from the imaging probe, the control method further includes measuring the length depth at different blood state images or frames and averaging the measurement results; and / or (iv) The control method further includes deleting any detected objects of a predetermined size and counting how many objects are more than a predetermined distance away from the imaging probe or counting how many objects overlap the BIA, and the predetermined distance is defined by using an image in which blood is present.

15. The control method of claim 12, wherein one of the following: (i) The control method further comprises calculating the relative position of the object and the imaging probe; (ii) the control method further includes calculating the relative position of the object and the imaging probe, and the control method further includes omitting calculating the relative position of the object and the imaging probe; (iii) in the case where the BIA is used, the BIA is represented as an area at a predetermined distance from the tip of the imaging probe, or a circular area above the tip of the imaging probe is represented as the BIA; (iv) the BIA is defined or predefined using images in which blood is present; and / or (v) The number of pixels that are more than a predetermined height away from the imaging probe tip is indicated.

16. The control method of claim 12, wherein one of the following: (i) importing the plurality of A-lines or the one or more images in a scanning mode, wherein the imaging probe is a full-speed spinning imaging probe; (ii) the predetermined value X for the counter is at least one of: 1, 2, 3, 4, 5, 6, or greater and / or is determined by a clinician based on how much time is needed for a procedure or imaging pullback and based on how long a clear state lasts; (iii) the control method further includes detecting how much the subject moves during blood imaging for optical coherence tomography (OCT); (iv) the control method further comprises determining or evaluating a clearing condition of the processed frame, A-line or image; (v) in a case where the number of objects that are spaced from the imaging probe by more than the imaging probe distance as the predetermined distance is equal to or greater than a predetermined threshold, the control method further includes determining that a blood vessel wall or a target in the image or frame is visible in the current image or frame; and / or (vi) in a case where the number of objects that are separated from the imaging probe by a distance exceeding the imaging probe as a predetermined distance is equal to or greater than a predetermined threshold, the control method further includes determining that a blood vessel wall or a target in an image or frame is visible in a current image or frame, and the predetermined threshold is one or more of the following: 2 or more, 3 or more, 4 or more, 5 or more, and / or a predetermined number or more, wherein the predetermined number is set by a user of the imaging probe or automatically set or loaded by the control method.

17. The control method of claim 12, wherein one of the following: (i) The control method further comprises flushing the imaging probe to remove the presence of blood; (ii) the control method further includes flushing the imaging probe to remove the presence of blood, and the control method further includes ensuring that the flushing and the automatic pullback are synchronized, or the flushing and the automatic pullback are performed in a synchronized manner; (iii) the control method further includes reducing, consolidating and / or minimizing one or more tasks of a user of the imaging probe during a catheter insertion or imaging probe procedure such that the user's work is also reduced, minimized and / or more efficient; (iv) the control method further includes reducing, consolidating and / or minimizing one or more tasks of a user of the imaging probe during a catheter insertion or imaging probe procedure such that the user's work is also reduced, minimized and / or more efficient, and the user's tasks involve one or more of: controlling live mode speed, pressing a button to control live mode speed, controlling scan mode speed, pressing a button to control scan mode speed, causing flushing to occur, pressing a button to cause flushing to occur, causing pullback to occur, and / or pressing a button to cause pullback to occur; and / or (v) The control method also includes triggering automatic retraction of the catheter or probe of the imaging device without any user interaction.

18. The control method of claim 12, wherein one of the following: (i) A lines, frames or images are defined by blocks or collections of A lines and when transformed to Cartesian coordinates form a two-dimensional (2D) optical coherence tomography (OCT) image or frame; (ii) during image or frame processing or pre-processing, the control method further comprises setting pixels corresponding to the imaging probe, artifacts and / or extravascular tissue regions to zero and applying filtering; (iii) during image or frame processing or preprocessing, the control method further comprises setting pixels corresponding to the imaging probe, artifacts and / or extravascular tissue regions to zero and applying filtering, and the filtering is a mean filter, a spatial filter and / or a sliding window or kernel spatial filter, which replaces the center value of the window with the mean intensity value of the pixels belonging to the window, and for image I and a window of size NxN, the value of the center pixel (i, j) of the window is replaced by Replace, where m, n are the pixels belonging to the window NxN; and / or (iv) During image or frame processing or preprocessing, the control method further comprises setting pixels corresponding to the imaging probe, artifacts and / or extravascular tissue regions to zero and applying filtering, and the filtering is Gaussian filtering or bilateral filtering, and / or the control method further comprises using convolution to replace the intensity of the central pixel of the mask with a weighted average of the intensities of neighboring pixels.

19. The control method of claim 12, wherein one of the following: (i) the control method further comprises applying image or frame segmentation by (a) applying automatic thresholding to the A-line, image or frame, (b) smoothing the segmented A-line, image or frame by removing objects of a predetermined or set size corresponding to image or frame artifacts, and (c) dividing the A-line, image or frame into three or more equal parts; (ii) the control method further comprises applying image or frame segmentation by (a) applying automatic thresholding to the A-line, image or frame, (b) smoothing the segmented A-line, image or frame by removing objects of a predetermined or set size corresponding to image or frame artifacts, and (c) dividing the A-line, multiple images or frames into three or more equal parts, and the automatic thresholding is Otsu thresholding; (iii) the control method further comprises applying image or frame segmentation by (a) applying automatic thresholding to the A-line, image or frame, (b) smoothing the segmented A-line, image or frame by removing objects of a predetermined or set size corresponding to image or frame artifacts, and (c) dividing the A-line, image or frame into three or more equal parts, and the automatic thresholding is Otsu thresholding, using the Otsu method to calculate the threshold Thr of the image I otsu , and will be less than Thr otsu setting pixels of an image I corresponding to an A-line, image or frame to zero values ​​so as to generate a binary image having an arterial wall and blood represented by non-zero objects; (iv) in order to determine whether a non-zero object corresponding to an image or frame artifact exists and to remove the non-zero object corresponding to the image or frame artifact from a set of non-zero objects to be used for detecting a boundary, the control method further comprises detecting objects smaller than a predetermined area to ensure that only objects remaining in the set correspond to a wall area and are used for detecting a boundary; (v) in order to determine whether a non-zero object corresponding to an image or frame artifact exists and to remove the non-zero object corresponding to the image or frame artifact from the set of non-zero objects to be used for detecting a boundary, the control method further includes detecting objects smaller than a predetermined area to ensure that only the remaining objects in the set correspond to the wall area and are used for detecting the boundary, and the predetermined area is the entire catheter area or the probe area, or 3% of the entire image or frame; and / or (vi) The control method further includes detecting a larger object and deleting an object that is smaller than the larger object by a predetermined percentage, wherein the predetermined percentage is any value in the range of 10% to 50%.

20. The control method according to claim 19, wherein the predetermined percentage is any value within a range of 20% to 30%.

21. The control method of claim 19, wherein the predetermined percentage is one or more of the following: 24%, 20%, 25%, 30%.

22. The control method of claim 12, wherein one of the following: (i) the control method further comprises determining whether the target or the arterial wall is visible for a predetermined number of consecutive frames or images; (ii) the control method further comprises determining whether the target or the arterial wall is visible for a predetermined number of consecutive frames or images, and the predetermined number of consecutive frames or images is one or more of: three, four, five and / or six; (iii) the control method further comprises determining whether the target or the arterial wall is visible for a predetermined number of consecutive frames or images, and in the event that the target or the arterial wall is visible, the control method triggers the automatic pullback; (iv) the counter operates to ensure that blood is sufficiently cleared so that automatic pullback is synchronized with improved or optimal clearance conditions; (v) each time a clear condition is detected, the counter is incremented; and / or (vi) The control method also includes determining whether the target or arterial wall is visible for a predetermined number of consecutive frames or images, and the control method also includes detecting whether the number of objects that do not overlap with the BIA is greater than a predetermined threshold, so that it is determined that the target or arterial wall is revealed or visible and the blood is flushed to indicate a clear state, wherein the predetermined threshold is three or more.

23. A non-transitory computer-readable storage medium storing at least one program, the at least one program being used to cause a computer to execute a control method for an imaging device for triggering automatic retraction, the control method comprising: (a) Import multiple A-lines or one or more images; (b) Initialize the counter; (c) segmenting the A-line or image; (d) dividing the segmented A-line or image into three or more equal parts; (e) defining a blood imaging area (BIA), which is the area surrounding the imaging probe in the presence of blood; (f) detecting a number of objects that do not overlap with the BIA or are more than a predetermined distance away from the imaging probe in a current frame of one or more frames of the segmented A-line or image; (g) Perform the counting step: In the event that the number of objects is greater than or equal to N, where N is the minimum accepted number of objects defining a partially cleared or cleared state, incrementing a counter by a set or predetermined amount or by 1, and In the event that the number of objects is less than N, setting the counter to 0 and repeating steps (c)-(g) for another frame or subsequent frames in the plurality of frames; and (h) triggering a pullback if the counter is X or greater, where X is a predetermined value, or if the counter has been incremented and the counter is less than X, repeating steps (c)-(g) for the next frame in the plurality of frames.

Images