Photobleached imaging apparatus or catheter, and methods for using same or performing photo-bleaching for same

Abstract

To provide one or more devices, systems, methods, and storage media for performing photobleaching and / or performing intravascular imaging and / or optical coherence tomography (OCT) while detecting and / or characterizing one or more tissues.SOLUTION: Examples of applications include imaging, evaluating and diagnosing biological objects, such as, for Gastro-intestinal, cardio and / or ophthalmic applications, and being obtained via one or more optical instruments, such as, optical probes, catheters, capsules and needles (for example., a biopsy needle). Preferably, intravascular imaging devices, systems, methods, and storage mediums involve photobleaching feature(s) and / or include or involve a method, such as, using one or more images to detect and / or characterize one or more tissues and / or to perform co-registration. Photo-bleached devices or systems may be used to improve imaging, including for fluorescence devices or systems.SELECTED DRAWING: Figure 3A

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application is related to and claims priority to U.S. Patent Application No. 63 / 570,514, filed March 27, 2024, the entire disclosure of which is incorporated herein by reference in its entirety.

[0002] The present disclosure relates generally to the fields of computational imaging, background noise reduction and / or stabilization in imaging, and / or medical imaging, and more particularly to photobleached devices / apparatuses, systems, methods, and storage media for performing tissue characterization and / or imaging in one or more images and / or using one or more imaging modalities (e.g., angiography, optical coherence tomography (OCT), multi-modality OCT (MM-OCT), near-infrared fluorescence (NIRF), near-infrared autofluorescence (NIRAF), OCT-NIRAF, fluorescence, white light backreflection, near-infrared spectroscopy (NIRS), robotic imaging, robotic imaging, continuum robotic imaging, etc.). Example OCT applications include imaging, evaluation, and diagnosis of biological objects, such as gastrointestinal, cardiac, and / or ophthalmic applications, and acquisition with one or more optical instruments (e.g., one or more optical probes, one or more catheters, one or more endoscopes, one or more capsules, one or more needles (e.g., biopsy needles), etc.). Disclosed herein are one or more instruments, systems, methods, and storage media for characterizing, examining, and / or diagnosing a sample or object (e.g., tissue, organ, patient part, etc.) and / or measuring the viscosity of a sample or object using a device or system that uses and / or controls one or more imaging modalities. [Background technology]

[0003] Fiber optic catheters and endoscopes have been developed to access internal organs. For example, in cardiology, OCT was developed to view (e.g., capture and visualize) depth-resolved images of vessels using catheters. Catheters may include a sheath, coils, and optical probes and can be navigated to the coronary arteries.

[0004] Optical coherence tomography (OCT) is a technique for obtaining high-resolution cross-sectional images of tissues and materials, enabling real-time visualization. The goal of OCT is to measure the time delay of light using interference optics or methods, such as Fourier transform or Michelson interferometers. Light from a light source is split by a splitter (e.g., a beam splitter) and sent to a reference arm and a sample (or measurement) arm. The reference beam is reflected from a reference mirror (partially reflective or other reflective element) in the reference arm, and the sample beam is reflected or scattered from the sample in the sample arm. The two beams are combined (or recombined) at the splitter, producing interference fringes. The output of the interferometer is detected by one or more detectors, such as photodiodes or multi-array cameras, in one or more instruments, such as a spectrometer (e.g., a Fourier transform infrared spectrometer). Interference fringes are produced when the path length of the sample arm matches the path length of the reference arm within the coherence length of the light source. By evaluating the output beams, the spectrum of the input radiation as a function of frequency can be derived. The frequency of the interference fringes corresponds to the distance between the sample and reference arms. The higher the frequency, the greater the difference in path length. OCT optical probes may use single-mode fibers, while double-clad fibers may be used for fluorescence and / or spectroscopy. Multi-modality systems, such as OCT, fluorescence, and / or spectroscopy systems using optical probes, have been developed to simultaneously acquire multiple pieces of information.

[0005] Spectral encoding endoscopy (SEE) is an endoscopic technique that uses a broadband light source, a rotating or vibrating diffraction grating, and a spectroscopic detector to encode spatial information from a sample. When a sample is illuminated with light, the light is spectrally dispersed along a single illumination line, causing the dispersed light to illuminate specific locations along the illumination line with specific wavelengths. When the light reflected from the sample is detected by a spectrometer, its intensity distribution is analyzed as reflectance along a line whose wavelength encodes spatial information. By rotating or vibrating the diffraction grating to scan the illumination line, a two-dimensional image of the sample is obtained.

[0006] To obtain cross-sectional images of tubes and cavities such as blood vessels, the esophagus, and the nasal cavity, optical probes are rotated by a fiber optic rotary joint (FORJ). A FORJ is a joint that functions to rotate one end of a fiber and / or optical probe. A free-space beam coupler is typically incorporated to separate the fixed and rotating fibers within the FORJ. Furthermore, helical scan pattern images can be obtained by simultaneously translating the optical probe longitudinally during rotation. This translation is most commonly achieved by pulling the tip of the probe back along the guidewire toward the proximal end, hence the term pullback.

[0007] Multi-modality systems, such as OCT, fluorescence and / or spectroscopy systems using optical probes, have been developed to simultaneously acquire multiple pieces of information.

[0008] In catheter- or endoscope-based fluorescence systems, the catheter may emit light when excitation light couples into the catheter's optical fiber (which may contribute to or contribute to catheter background noise). Silica-core optical fibers are sometimes used to deliver excitation light to samples such as tissue. However, silica-core fibers generate a Raman signal when the fiber is excited (e.g., as described by Stolen et al., "Raman response function of silica-core fibers," J. Opt. Soc. Am. B, Vol. 6, pp. 1159-1166 (June 1989)); the entire contents of which are incorporated herein by reference). Raman scattering contributes to catheter background noise.

[0009] Some systems use spectral separation of the catheter background noise and tissue fluorescence, using an optimized long-pass filter. However, when the catheter background noise is high, the intensity of the tissue fluorescence is also high. Therefore, when the background noise is spectrally removed using a long-pass filter, the fluorescence signal is also removed, resulting in a poor signal-to-noise ratio (SNR) of the fluorescence system.

[0010] Therefore, it would be desirable to provide at least one imaging or optical device / instrument, system, method, and storage medium that is capable of reducing and stabilizing background noise (e.g., catheter background noise) without loss of fluorescence signal and that is capable of evaluating and characterizing targets, samples, or objects (e.g., tissues, organs, patient parts, ducts, etc.). It would also be desirable to provide techniques and / or structures of one or more probes / catheters / robotic devices used in at least one optical instrument, assembly, or system for characterizing targets, samples, or objects (e.g., tissues, organs, patient parts, ducts, etc.) to achieve consistent and reliable detection and / or characterization / imaging results with high efficiency and reasonable manufacturing and maintenance costs. Summary of the Invention

[0011] Accordingly, it is a broad object of the present disclosure to provide imaging (e.g., OCT, NIRF, NIRAF, white light backreflection, near-infrared spectroscopy (NIRS), robotics, continuum robotics, etc.) devices, systems, methods, and storage media for using and / or controlling multiple imaging modalities that can reduce and stabilize background noise (e.g., catheter background noise) without loss of fluorescence signal and that can evaluate and characterize tissue in one or more images (e.g., intravascular images) with higher or highest success and / or efficiency. It is also a broad object of the present disclosure to provide devices, systems, methods, and storage media for OCT using interference optics such as interferometers (e.g., spectral-domain OCT (SD-OCT), swept-wavelength OCT (SS-OCT), multimodal OCT (MM-OCT), intravascular ultrasound (IVUS), near-infrared autofluorescence (NIRAF), near-infrared spectroscopy (NIRS), near-infrared fluorescence (NIRF), therapy using light, sound, or other radiation sources, etc.).

[0012] It is a further broad object of the present disclosure to provide one or more methods or techniques operable to perform one or more of the following: (i) automatically detecting one or more tissue types (e.g., calcium, lipid, fibrous tissue, mixed tissue, other tissue, etc.) across the catheter or probe pullback for one or more intravascular images (e.g., OCT images); (ii) in one or more embodiments, reducing the computational time for characterizing the pullback by processing a single image (e.g., constructing and processing a carpet view image, which can process only one image instead of multiple (e.g., 400) images); constructing and processing an intravascular image; (iii) providing accurate fluorescence measurements and preventing or avoiding inaccurate measurements due to degradation of one or more detectors; (iv) reducing and stabilizing background noise (e.g., catheter background noise) without loss of fluorescence signal; (v) increasing the signal-to-noise ratio and / or increasing sensitivity for detecting weak fluorescence (e.g., NIRF, NIRAF, etc.) signals; (vi) using photobleached optical probes for catheters and / or one or more methods for photobleaching optical probes; and / or (vii) in one or more embodiments, performing more detailed tissue detection or characterization and / or imaging.

[0013] Some methodologies of the present disclosure developed to overcome the aforementioned problems of catheter background noise use devices, systems, methods, storage media, etc. that function to do one or more of the following: reduce and stabilize catheter background noise without loss of fluorescence signal; increase signal-to-noise ratio; increase sensitivity to detect weak fluorescence (e.g., NIRF, NIRAF, etc.) signals; and / or use a photobleached optical probe in the catheter. In one or more embodiments, to increase the SNR, background noise can be reduced without reducing the fluorescence signal.

[0014] As previously discussed, the fiber optic catheters and endoscopes of the present disclosure have been developed to access internal organs, tissues, and other targets, samples, or objects. For example, in cardiology, OCT (optical coherence tomography), white light backreflection, NIRS (near-infrared spectroscopy), and fluorescence technologies have been developed to obtain structural and / or molecular images of blood vessels using catheters. A catheter (comprising a sheath and an optical probe in one or more embodiments) can be navigated to a target, sample, or object, such as a coronary artery.

[0015] To obtain cross-sectional images of vessels and cavities (e.g., a vessel, an esophagus, or at least one nasal cavity), the optical probe can be rotated using a fiber optic rotary joint (FORJ). Furthermore, by simultaneously translating the optical probe longitudinally while rotating, helical scan pattern images can be obtained. This translation can be performed by pulling the tip of the probe back toward the proximal end, and is referred to as pullback. While particular vessels, cavities, or other targets, samples, or objects (e.g., coronary arteries) may be discussed herein, this does not limit the targets, samples, or objects with which features of the present disclosure may be used. Furthermore, although this specification may discuss imaging modalities that may be used in combination (e.g., an intravascular OCT-fluorescence system), this does not limit the imaging modalities that may be used with one or more features of the present disclosure.

[0016] In one or more embodiments, the photobleached imaging device can include a catheter having an optical probe, the optical probe having one or more optical fibers operable to deliver and receive light, wherein the optical probe or one or more components of the optical probe are photobleached. In one or more embodiments, the optical system can include an interference system and one or more detectors, wherein the interference system (i) receives light from a light source and splits the light into a first light that travels along a sample arm of the interference system and is irradiated onto an object or sample and a second reference light, (ii) sends the second reference light along a reference arm of the interference system and reflects it off a reference reflection of the interference system, and (iii) combines or recombines the reflected or scattered light of the first light irradiated onto the object or sample and the reflected second reference light, causing them to interfere with each other to generate an interference light that produces one or more interference fringes, and the one or more detectors (ii) continuously acquires the interference light and / or the one or more interference fringes and measures the interference between the combined or recombined light or the one or more interference fringes to acquire data related to one or more imaging modalities. The wavelength of the first light is shorter than the wavelength of the reflected or scattered light and / or shorter than the wavelength of the generated interference light. The interference optics or the probe of the interference optics is photobleached. In one or more embodiments, the interference optics or the probe of the interference optics may include a double-clad fiber. In one or more embodiments, the emission intensity of the photobleached interference optics or the photobleached probe may stabilize within 10% of the average intensity over a predetermined or set period of time (e.g., 2 minutes, about 2 minutes, a time in the range of 1 minute to 2 minutes, a time in the range of about 1 minute to about 2 minutes, etc.).

[0017] In one or more embodiments, the one or more imaging modalities may include one or more of optical coherence tomography (OCT), single-modality OCT, multi-modality OCT, swept-wavelength OCT, optical frequency domain imaging (OFDI), intravascular ultrasound (IVUS), another luminal imaging modality, near-infrared spectroscopy (NIRS), near-infrared fluorescence (NIRF), near-infrared autofluorescence (NIRAF), near-infrared, fluorescence, and an intravascular imaging modality.

[0018] In one or more embodiments, a method of photobleaching an interference optics system and / or one or more optical probes may include using or providing an excitation laser having a wavelength between 400 nm and 900 nm; coupling the excitation laser to the interference optics system, one or more optical probes, and / or one or more components of the one or more optical probes; and exciting the interference optics system, one or more optical probes, and / or one or more components of the one or more optical probes with the excitation laser for a set or predetermined amount of time or more. In one or more embodiments, the set or predetermined amount of time is 30 minutes or about 30 minutes. In one or more embodiments, a user can set the amount of time for performing photobleaching. In one or more embodiments, the one or more optical probes and / or one or more components of the one or more optical probes (or each) may include or be composed of double-clad fiber. In one or more embodiments, the set or predetermined amount of time for performing excitation may be 24 hours or longer. In one or more embodiments, the wavelength of the excitation laser or light may be 635 nm.

[0019] In one or more embodiments, one or more processors may perform or control the photobleaching method. The one or more processors may receive a set or predetermined amount of time to perform photobleaching, or may automatically calculate and set the set or predetermined amount of time (e.g., based on the number of components or structures to be photobleached, based on the size and shape of the structures or the number of components to be photobleached, etc.).

[0020] In one or more embodiments, a photobleached imaging device may include an interference optical system and one or more detectors. The interference optical system (i) receives light from a light source and splits the light into a first light that travels along a sample arm of the interference optical system and illuminates an object or sample, and a second reference light; (ii) sends the second reference light along a reference arm of the interference optical system and reflects it off a reference reflection of the interference optical system; and (iii) combines or recombines the reflected or scattered light of the first light illuminated by the object or sample and the reflected second reference light, causing them to interfere with each other to generate an interfering light that produces one or more interference fringes. The one or more detectors (i.e., one or more detectors) continuously acquire the interfering light and / or the one or more interference fringes and measure the interference between the combined or recombined light or the one or more interference fringes to obtain data related to one or more imaging modalities. The wavelength of the first light is shorter than the wavelength of the reflected or scattered light and / or shorter than the wavelength of the generated interfering light. One or more components of the interference optical system or an optical probe or catheter of the interference optical system are photobleached. In one or more embodiments, one or more of the following may occur: (i) one or more detectors are operable to continuously acquire interference light and / or one or more interference fringes in the photobleached interference optic, optical probe, or catheter such that the emission intensity of the photobleached interference optic, optical probe, or catheter stabilizes to within 10% or about 10% of the average intensity over a predetermined or set period of time and / or such that the signal-to-noise ratio of the interference optic is increased compared to the non-photobleached interference optic, optical probe, or catheter; and / or (ii) the interference optic, or the optical probe or catheter of the interference optic, comprises a double-clad fiber. One or more of the following may occur: (i) the emission intensity of the photobleached interference optic, optical probe, or catheter stabilizes to within 10% or about 10% of the average intensity over a predetermined or set period of time; and / or (ii) the predetermined or set period of time is any of 2 minutes, about 2 minutes, a time in a range of 1 minute to 2 minutes, and / or a time in a range of about 1 minute to about 2 minutes.

[0021] The imaging device may include one or more processors operable to perform an optical probe or catheter pullback and / or acquire one or more images or frames of one or more imaging modalities from the optical probe or catheter pullback. In one or more embodiments, the one or more imaging modalities may include one or more of the following: optical coherence tomography (OCT), single-modality OCT, multi-modality OCT, swept-wavelength OCT, optical frequency domain imaging (OFDI), intravascular ultrasound (IVUS), another luminal imaging modality, near-infrared spectroscopy (NIRS), near-infrared fluorescence (NIRF), near-infrared autofluorescence (NIRAF), near-infrared, fluorescence, and / or an intravascular imaging modality. The one or more processors may be further operable to display the one or more images on a display, store the one or more images in a memory, or use the one or more images to train one or more models or AI networks to automatically detect or perform photobleaching and / or automatically acquire one or more images in one or more imaging modalities. One or more of the following may occur: (i) the trained model may be any one or a combination of the following: a neural net model or neural network model; a deep convolutional neural network model; a recurrent neural network model using long-short-term memory that can take into account temporal relationships between images or frames; a generative adversarial network (GAN) model; a consistent generative adversarial network (cGAN) model; a three-cycle consistent generative adversarial network (3cGAN) model; a model that can take into account temporal relationships between images or frames; a model that can take into account temporal relationships including tissue location and / or photobleach location during in-tube pullback and / or characterization data of tissue and / or photobleach during in-tube pullback; a model that can use prior knowledge about the procedure and incorporate that prior knowledge into the machine learning algorithm or loss function; a model that uses feature pyramids that can take into account different image resolutions and / or models that use residual learning techniques; a segmentation model;a segmentation model with post-processing; a model with pre-processing; a model with post-processing; a segmentation model with pre-processing; a deep learning or machine learning model; a semantic segmentation model or classification model; an object detection or regression model; an object detection or regression model with pre-processing or post-processing; a combination of a semantic segmentation model and an object detection or regression model; a model using iterative segmentation model techniques; a model using feature pyramids; a generic algorithm that operates to improve multiple models for improved performance; and / or a model using iterative object detection or regression model techniques; and / or (ii) the one or more processors may be further operable to use one or more neural networks or convolutional neural networks to perform one or more of the following: loading a trained model of an image including a photobleached region; performing photobleaching on the catheter; determining whether the photobleached region is correct or accurate; determining one or more characteristics of the one or more objects, targets, or samples in the one or more images; identifying or detecting the one or more objects, targets, or samples; overlaying data on at least one of the one or more images to indicate the intravascular image, the photobleached region, or the location of the object, target, or sample; automatically identifying and locating the photobleached portion or component of the interferometric optics, optical probe, or catheter using image processing and machine learning (ML) or deep learning; automatically identifying and locating the one or more objects, targets, or samples using image processing and machine learning (ML) or deep learning; displaying the results of the photobleach identification / detection or characterization on a display; and / or acquiring or receiving image data during a pullback movement of the catheter or optical probe;

[0022] In one or more embodiments, the imaging device may further include one or more of the following: (i) a light source operable to emit light; (ii) a light source operable to emit light, the light acting as an excitation laser or light having a wavelength of 400 nm to 900 nm or 635 nm; (iii) a light source operable to emit light, the light being emitted as an excitation laser or light and coupling the excitation laser or light to the interference optics, the optical probe, and / or one or more components of the optical probe and / or catheter; (iv) a light source operable to emit light, the light being emitted as an excitation laser or light and exciting the interference optics, the optical probe, and / or one or more components of the optical probe and / or catheter with the excitation laser or light for a set or predetermined amount of time or more. and / or (v) a light source operable to emit light, the light source emitting light as an excitation laser or light that excites the interference optics, the optical probe, and / or one or more components of the optical probe and / or catheter with the excitation laser or light for a set or predetermined amount of time or more, wherein the set or predetermined amount of time is one or more of: 30 minutes, more than 30 minutes, in a range of 30 minutes to 24 hours, 24 hours, more than 24 hours, an amount of time calculated or set / received by one or more processors of the imaging device or a user of the imaging device, and / or an amount of time calculated or set by one or more processors of the imaging device or a user of the imaging device based on the size and shape of or the number of components or structures to be photobleached.

[0023] If the interference optical system, the optical probe or catheter, or one or more components of the optical probe or catheter include or are attached to a double-clad fiber, one or more of the following may be present: (i) the imaging device further includes one or more processors operable to perform pullback of the optical probe or catheter and / or acquire one or more images or frames of one or more imaging modalities from the pullback of the optical probe or catheter; (ii) the imaging device further comprises one or more processors, the one or more processors operable to perform pullback of the optical probe or catheter and / or acquire one or more images or frames of one or more imaging modalities from the pullback of the optical probe or catheter, and the one or more processors further include, or operate in conjunction with, a core / clad ratio adjustment processor or unit operable to control the ratio of excitation laser or light for the core and clad of the double-clad fiber. (iii) the imaging device further comprises one or more processors, the one or more processors operable to perform pullback of the optical probe or catheter and / or to acquire one or more images or frames of one or more imaging modalities from the pullback of the optical probe or catheter, the one or more processors further comprising a core / clad ratio adjustment processor or unit operable to control a ratio of pump laser or light for the core and clad of the double-clad fiber, or The device functions in conjunction with a laser or unit, and the ratio is one or more of the following: 10% or more of the pump laser or light is sent to the cladding and the ratio value of the amount of pump laser or light sent to the core is 90% or less; 50% or about 50% of the pump laser or light is sent to the cladding and 50% or about 50% or more of the pump laser or light is sent to the core; 47% is sent to the cladding and 53% is sent to the core; and / or 50%-x% is sent to the cladding and 50%+x% is sent to the core, where x% is a value equal to the difference between 50% and the percentage value allocated to the cladding;and / or (iv) the interference optical system further comprises a fluorescence subsystem and a subsystem of another imaging modality;

[0024] The imaging device may further include a lens unit or one or more lens components that function to filter the excitation laser or light of the light source and transmit radiation to and / or from the interference optics, the optical probe, and / or one or more components of the optical probe and / or catheter. One or more of the following may occur: (i) one or more components of the optical probe and / or catheter include or comprise a double-clad fiber; and / or (ii) the total optical power of the excitation laser or light sent to the interference optics, the optical probe, and / or one or more components of the optical probe and / or catheter is one of the following: the same as the nominal intensity compared to when the excitation laser or light is used as part of the system, the interference optics, the optical probe, and / or one or more components of the optical probe and / or catheter, and is at least 0.1 mW; two or more times higher than the nominal intensity, and is at least 0.2 mW or at least 0.5 mW; ten or more times higher than the nominal intensity, and is at least 1 mW; and / or one hundred or more times higher than the nominal intensity, and is at least 10 mW.

[0025] In one or more embodiments, a method of photobleaching an optical probe and / or one or more components of an imaging device may include: performing photobleaching on the optical probe, the optical probe used in the catheter, and / or one or more components of the optical probe using an excitation laser or light having a wavelength in a predetermined range or value for at least a predetermined or set amount of time, such that a lower and more stable background emission noise and / or a high signal-to-noise ratio is achieved for the optical probe and / or one or more components of the optical probe. In one or more embodiments, a method of photobleaching on an interference optics, an optical probe, and / or one or more components of the optical probe and / or catheter may include: performing photobleaching on the interference optics, the optical probe, and / or one or more components of the optical probe and / or catheter using an excitation laser or light having a wavelength in a predetermined range or value for at least a predetermined or set amount of time, such that a lower and more stable background emission noise and / or a high signal-to-noise ratio is achieved for the interference optics, the optical probe, and / or one or more components of the optical probe and / or catheter. In one or more embodiments, the predetermined range or value is one or more of 400 nm to 900 nm and / or 635 nm, and the predetermined or set amount of time is one or more of the following: 30 minutes; 30 minutes or more; in the range of 30 minutes to 24 hours; 24 hours; 24 hours or more; an amount of time calculated or set / received by one or more processors of the imaging device or a user of the imaging device; and / or an amount of time calculated or set by one or more processors of the imaging device or a user of the imaging device based on the size and shape of the object to be photobleached or the number of components or structures to be photobleached.The method may further include one or more of the following: (i) using one or more detectors of an imaging device to continuously acquire interference light and / or one or more interference fringes in the photobleached optical interferometry system, optical probe, or catheter, such that the emission intensity of the photobleached optical interferometry system, optical probe, or catheter stabilizes within 10% or about 10% of the average intensity over a predetermined or set period of time and / or such that the signal-to-noise ratio of the interferometry system is increased compared to a non-photobleached interferometry system; and / or (ii) using an interferometry system or an optical probe or catheter of the interferometry system while including a double-clad fiber. Any of the methods of the present disclosure may use any of the features described for the apparatus, system, other methods, storage medium, artificial intelligence (AI) system, method, etc. of the present disclosure. For example, the interference optical system may be operable to (i) receive light from a light source and split the light into a first light that travels along a sample arm of the interference optical system and illuminates the object or sample, and a second reference light; (ii) send the second reference light along a reference arm of the interference optical system and reflect it off a reference reflector of the interference optical system; and (iii) combine or recombine the reflected or scattered light from the first light illuminated by the object or sample and the reflected second reference light, causing them to interfere with each other to generate an interference light that produces one or more interference fringes. The imaging device may include one or more detectors that are operable to continuously acquire the interference light and / or one or more interference fringes and measure the interference between the combined or recombined light or the one or more interference fringes to obtain data related to one or more imaging modalities. The wavelength of the first light is shorter than the wavelength of the reflected or scattered light and / or shorter than the wavelength of the generated interference light, and one or more components of the interference optical system or the optical probe or catheter of the interference optical system are photobleached.

[0026] In one or more embodiments, a computer-readable storage medium having stored thereon at least one program operable to cause one or more processors to execute a method of photobleaching one or more components of an interference optics system, an optical probe, and / or the optical probe and / or catheter of an imaging device, the method may include any of the features described herein, such as, for example, performing photobleaching on one or more components of the interference optics system, the optical probe, and / or the optical probe and / or catheter using an excitation laser or light having a wavelength in a predetermined range or value for at least a predetermined or set amount of time, such that lower and more stable background radiation noise and / or a high signal-to-noise ratio is achieved for the interference optics system, the optical probe, and / or the one or more components of the optical probe and / or catheter.

[0027] In one or more embodiments, the object, target, or sample may include one or more of the following: a tube; a target, specimen, or object; a tissue; a patient; an interferometric optical system; one or more optical probes; and / or one or more components of one or more optical probes.

[0028] The one or more processors may further be operable to perform coregistration by coregistrating an acquired or received angiographic image or constructed image (e.g., carpet view) with one or more acquired intravascular images (such as OCT or IVUS images or frames).

[0029] In one or more embodiments, the loaded trained model may be any one or combination of the following: a segmentation (classification) model; a segmentation model with pre-processing; a segmentation model with post-processing; an object detection (regression) model; an object detection model with pre-processing; an object detection model with post-processing; a combination of a segmentation (classification) model and an object detection (regression) model; a deep convolutional neural network model; a recurrent neural network model with long-short-term memory that can take into account temporal relationships between images or frames; a model using a feature pyramid that can take into account different image resolutions; a generic algorithm that functions to improve multiple models for improved performance (compared to not using the generic algorithm); a model that uses residual learning techniques; and / or other models described herein or known to those of skill in the art.

[0030] In one or more embodiments, the one or more processors may be further operable to perform one or more of the following: (i) displaying on the display an image of each of the one or more imaging modalities, the one or more imaging modalities including a tomography image, an optical coherence tomography (OCT) image, a fluorescence image, a near-infrared autofluorescence (NIRAF) image, a near-infrared autofluorescence (NIRAF) image at the predetermined view, carpet view, and / or indicator view, a near-infrared fluorescence (NIRF) image, a near-infrared fluorescence (NIRF) image at the predetermined view, carpet view, and / or indicator view, and a near-infrared fluorescence (NIRF) image; (ii) displaying, including one or more of: a near-infrared (NIRS) image, a three-dimensional (3D) rendering, a 3D rendering of the vessel, a 3D rendering of the vessel in a semi-vessel view or display, a 3D rendering of the object, a lumen profile, a lumen diameter display, a longitudinal view, a computed tomography (CT), a magnetic resonance imaging (MRI), an intravascular ultrasound (IVUS), an X-ray image or view, and an angiography view; and (ii) changing or updating the display based on the results of the tissue or tissue property assessment, based on the results of the photobleaching assessment, and / or based on the updated position of the probe or catheter.

[0031] One or more embodiments of a non-transitory computer-readable storage medium having stored thereon at least one program for causing a computer to execute a method for training a model using artificial intelligence can be used in conjunction with any of the methods described herein (e.g., a method for assessing / determining one or more tissues or tissue properties, a method for assessing / determining and / or performing one or more photobleaching properties).

[0032] One or more embodiments of any of the methods described herein (e.g., training methods, detection methods, imaging or visualization methods, photobleaching methods, artificial intelligence methods, etc.) can be used in conjunction with any feature of the devices, systems, other methods, storage media, or other structures described herein.

[0033] One or more of the artificial intelligence features described herein that may be used in one or more embodiments of the present disclosure include using one or more of the following: deep learning, computer vision tasks, keypoint detection, proprietary architectures of models, proprietary training processes or algorithms, proprietary optimization processes or algorithms, input data preparation techniques, input to model mapping, pre-processing, post-processing, and / or interpretation of output data, for example, substantially as described herein or as shown in any one of the accompanying drawings.

[0034] In one or more embodiments, an algorithm such as the Viterbi algorithm can be used to evaluate and determine tissue and / or one or more tissue properties and / or photobleaching.

[0035] One or more embodiments of the present disclosure may track and / or calculate the success rate of assessing a tissue or tissue property and / or the success rate of assessing a photobleach or photobleach property.

[0036] The following paragraphs describe certain illustrative embodiments. Other embodiments may include alternatives, equivalents, and modifications. Furthermore, the illustrative embodiments may include some novel features, and certain features may not be essential to all embodiments of the devices, systems, and methods described herein.

[0037] According to other aspects of the present disclosure, described herein are one or more additional devices, one or more systems, one or more methods, and one or more storage media that use OCT and / or other imaging modality techniques to perform tissue characterization, perform photobleaching and / or photobleaching characterization, and perform co-registration using artificial intelligence (e.g., deep learning or machine learning) that uses the results of the tissue detection and / or tissue characterization and / or the results of the photobleaching and / or photobleaching characterization to perform co-registration, etc. Further features of the present disclosure will be in part understood, and in part apparent, from the following description and with reference to the accompanying drawings.

[0038] In accordance with one or more embodiments of the present disclosure, devices, systems, methods, and storage media for tissue detection and / or tissue characterization and / or photobleaching and / or photobleaching characterization in one or more images can function to characterize biological matter such as blood, mucus, tissue (including various types of tissue), and the like.

[0039] It should be noted that one or more embodiments of the tissue detection and / or characterization methods or features and / or one or more embodiments of the photobleaching and / or photobleaching characterization methods or features of the present disclosure can be used in other imaging systems, devices, or instruments in which images are formed from the reflection and scattering of signals within a tissue sample using a scanning probe. For example, IVUS images can be processed in addition to or instead of OCT images.

[0040] One or more embodiments of the present disclosure can be used in clinical applications, such as intravascular imaging, atherosclerotic plaque diagnosis, cardiac stent evaluation, balloon sinuplasty, sinus stent placement, arthroscopy, ophthalmology, ear research, veterinary uses and research, etc.

[0041] In accordance with at least another aspect of the present disclosure, one or more of the techniques described herein may be employed to reduce or minimize the number of optical components, and to reduce the cost of manufacturing and / or maintaining one or more of the devices, equipment, systems, and storage media by virtue of efficient techniques for reducing the cost of use / manufacturing the devices, equipment, systems, and storage media.

[0042] In accordance with other aspects of the present disclosure, described herein are one or more additional devices, one or more systems, one or more methods, and one or more storage media that employ (or are used in conjunction with) one or more tissue detection and / or tissue characterization techniques and / or one or more photobleaching and / or photobleaching characterization techniques. Further features of the present disclosure will be in part apparent and in part understood from the following description and by reference to the accompanying drawings. [Brief explanation of the drawings]

[0043] For the purpose of illustrating various aspects of the disclosure, where like numerals refer to like elements, the drawings show simplified forms that may be employed. It should be understood, however, that the disclosure is not intended to be limited to or by the precise arrangements and instrumentalities shown. To assist those skilled in the art in making and using the subject matter herein, reference is made to the accompanying figures and drawings.

[0044] [Figure 1] 1A is a schematic diagram illustrating at least one embodiment of a system that may be used to perform display and control of one or more imaging modalities and / or at least perform photobleaching and / or track / assess photobleaching characteristics, according to one or more aspects of the present disclosure. FIG. 1B is a schematic diagram illustrating an imaging system for performing one or more steps for processing image data and / or at least detect or identify photobleaching and / or track / assess photobleaching characteristics, according to one or more aspects of the present disclosure. [Figure 2] FIG. 2 is a diagram of at least one embodiment of a catheter that may be used in conjunction with one or more embodiments for performing at least photobleaching and / or tracking / assessing photobleaching characteristics in accordance with one or more aspects of the present disclosure. [Figure 3A] FIG. 3A illustrates one or more multi-modality systems (e.g., OCT and fluorescence) embodiments that may utilize one or more detectors, one or more processors, and / or one or more photobleaching features or techniques in accordance with one or more aspects of the present invention. [Figure 3B] FIG. 3B illustrates an embodiment of one or more multi-modality systems (e.g., OCT and fluorescence) that may utilize one or more detectors, one or more processors, and / or one or more photobleaching features or techniques in accordance with one or more aspects of the present invention. [Figure 4] FIG. 4 is a schematic diagram of at least one free-space beam combiner of a patient interface unit (PIU) (which may be used in conjunction with a FORJ) that may be used in accordance with one or more aspects of the present disclosure. [Figure 5] FIG. 5 shows a graph for at least one example illustrating how radiated noise from at least one optical probe changes when exciting the at least one optical probe that may be used in accordance with one or more aspects of the present disclosure. [Figure 6] FIG. 6 illustrates a graph of at least one embodiment of an application in which the intensity of the radiation varies by no more than 10% over a two minute period, according to one or more aspects of the present disclosure. [Figure 7] FIG. 7 shows a schematic diagram of at least one device or system that can be used for photobleaching, according to one or more embodiments of the present disclosure. [Figure 8A] FIG. 8A shows a graph of at least one test after photobleaching, according to one or more embodiments of the present disclosure. [Figure 8B] FIG. 8B illustrates at least one embodiment of a method for performing photobleaching, according to one or more aspects of the present disclosure. [Figure 9A]FIG. 9A illustrates at least one embodiment of an apparatus or system for utilizing one or more imaging modalities and / or artificial intelligence to perform imaging, photobleaching, and / or coregistration in accordance with one or more aspects of the present disclosure. [Figure 9B] FIG. 9B illustrates at least another embodiment of an imaging device or system for utilizing one or more imaging modalities and artificial intelligence to perform imaging, photobleaching, and / or coregistration in accordance with one or more aspects of the present disclosure. [Figure 9C] FIG. 9C illustrates at least a further embodiment of an imaging (e.g., OCT and NIRF / NIRAF, OCT and fluorescence, etc.) device or system for utilizing one or more imaging modalities and artificial intelligence to perform imaging, photobleaching, and / or co-registration in accordance with one or more aspects of the present disclosure. [Figure 10] FIG. 10 is a flowchart illustrating a method for performing imaging features, functions, or techniques according to one or more aspects of the present disclosure. [Figure 11] FIG. 11 shows a schematic diagram of an embodiment of a computer that can be used in conjunction with one or more embodiments of the apparatus or system or one or more methods described herein, according to one or more aspects of the present disclosure. [Figure 12] FIG. 12 shows a schematic diagram of another embodiment of a computer that can be used in conjunction with one or more embodiments of an apparatus or system or one or more methods described herein, in accordance with one or more aspects of the present disclosure. [Figure 13] FIG. 13 illustrates a schematic diagram of at least an embodiment of a system employing a computer or processor, memory, a database, and input / output devices in accordance with one or more aspects of the present disclosure. [Figure 14] FIG. 14 illustrates a generated architecture of a regression model that may be used for imaging, tissue characterization, tissue identification, photobleaching, performing coregistration, and / or other techniques described herein, in accordance with one or more aspects of the present disclosure. [Figure 15]FIG. 15 illustrates a convolutional neural network architecture that may be used for imaging, photobleaching, photobleaching characterization, tissue characterization, tissue detection, and / or other techniques described herein, in accordance with one or more embodiments of the present disclosure. [Figure 16] FIG. 16 illustrates a generated architecture of a regression model that may be used for imaging, photobleaching, photobleaching characterization, tissue characterization, tissue detection, and / or other techniques described herein, in accordance with one or more aspects of the present disclosure. [Figure 17] FIG. 17 is a schematic diagram of a segmentation model that may be used for imaging, photobleaching, photobleaching characterization, tissue characterization, tissue detection, and / or other techniques described herein, in accordance with one or more embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0045] Disclosed herein are one or more devices, systems, methods, and storage media for characterizing tissue or objects, using one or more imaging techniques or modalities (e.g., OCT, fluorescence, IVUS, MRI, CT, NIRF, NIRAF, NIRS, etc.), using artificial intelligence in assessing and detecting photobleaching and / or photobleaching properties, detecting tissue types and / or properties, and / or performing co-registration. Some embodiments of the present disclosure that may be implemented by one or more embodiments of the presently disclosed devices, systems, methods, and / or computer-readable storage media are depicted diagrammatically and visually in at least FIGS. 1A-17 and further described below.

[0046] One or more embodiments of the present disclosure provide at least one imaging or optical device / instrument, system, method, and storage medium capable of performing photobleaching and / or assessing / determining photobleaching characteristics.

[0047] One or more embodiments of the present disclosure provide at least one imaging or optical device / instrument, system, method, and storage medium capable of evaluating and characterizing a target, sample, or object (e.g., tissue, organ, patient part, vessel, etc.). Also, to achieve consistent and reliable detection and / or characterization results with high efficiency and reasonable manufacturing and maintenance costs, one or more embodiments of the present disclosure may provide or employ one or more probe / catheter / robotic device techniques and / or structures for characterizing a target, sample, or object (e.g., tissue, organ, patient part, vessel, etc.) that are used in at least one optical device, assembly, or system.

[0048] One or more embodiments of the present disclosure provide devices, systems, methods, and storage media for imaging (e.g., OCT, NIRF, NIRAF, robots, continuum robots, etc.) for using and / or controlling multiple imaging modalities, and can use machine learning (particularly deep learning) to perform photobleaching and / or evaluate and characterize tissue in one or more images (e.g., intravascular images) with a higher or maximum success rate. One or more embodiments of the present disclosure can function to provide OCT devices, systems, methods, and storage media that use interferometric optics such as interferometers (e.g., spectral-domain OCT (SD-OCT), swept-wavelength OCT (SS-OCT), multimodal OCT (MM-OCT), intravascular ultrasound (IVUS), near-infrared autofluorescence (NIRAF), near-infrared spectroscopy (NIRS), near-infrared fluorescence (NIRF), therapies using light, sound, or other radiation sources, etc.

[0049] Accordingly, it is a broad object of the present disclosure to provide imaging (e.g., OCT, NIRF, NIRAF, white light backreflection, near-infrared spectroscopy (NIRS), robotics, continuum robotics, etc.) devices, systems, methods, and storage media for using and / or controlling multiple imaging modalities that can reduce and stabilize background noise (e.g., catheter background noise) without loss of fluorescence signal and that can evaluate and characterize tissue in one or more images (e.g., intravascular images) with higher or highest success and / or efficiency. It is also a broad object of the present disclosure to provide devices, systems, methods, and storage media for OCT using interference optics such as interferometers (e.g., spectral-domain OCT (SD-OCT), swept-wavelength OCT (SS-OCT), multimodal OCT (MM-OCT), intravascular ultrasound (IVUS), near-infrared autofluorescence (NIRAF), near-infrared spectroscopy (NIRS), near-infrared fluorescence (NIRF), therapy using light, sound, or other radiation sources, etc.).

[0050] It is a further broad object of the present disclosure to provide one or more methods or techniques operable to perform one or more of the following: (i) automatically detecting one or more tissue types (e.g., calcium, lipid, fibrous tissue, mixed tissue, other tissue, etc.) across the catheter or probe pullback for one or more intravascular images (e.g., OCT images); (ii) in one or more embodiments, reducing the computational time for characterizing the pullback by processing a single image (e.g., constructing and processing a carpet view image, which can process only one image instead of multiple (e.g., 400) images); constructing and processing an intravascular image; (iii) providing accurate fluorescence measurements and preventing or avoiding inaccurate measurements due to degradation of one or more detectors; (iv) reducing and stabilizing background noise (e.g., catheter background noise) without loss of fluorescence signal; (v) increasing the signal-to-noise ratio and / or increasing sensitivity for detecting weak fluorescence (e.g., NIRF, NIRAF, etc.) signals; (vi) using photobleached optical probes for catheters and / or one or more methods for photobleaching optical probes; and / or (vii) in one or more embodiments, performing more detailed tissue detection or characterization and / or imaging.

[0051] Some methodologies of the present disclosure developed to overcome the aforementioned problems of catheter background noise use devices, systems, methods, storage media, etc. that function to do one or more of the following: reduce and stabilize catheter background noise without loss of fluorescence signal; increase signal-to-noise ratio; increase sensitivity to detect weak fluorescence (e.g., NIRF, NIRAF, etc.) signals; and / or use a photobleached optical probe in the catheter. In one or more embodiments, to increase the SNR, background noise can be reduced without reducing the fluorescence signal.

[0052] As previously discussed, the fiber optic catheters and endoscopes of the present disclosure have been developed to access internal organs, tissues, and other targets, samples, or objects. For example, in cardiology, OCT (optical coherence tomography), white light backreflection, NIRS (near-infrared spectroscopy), and fluorescence technologies have been developed to observe structural and / or molecular images of blood vessels using catheters. A catheter (comprising a sheath and an optical probe in one or more embodiments) can be navigated to a target, sample, or object, such as a coronary artery.

[0053] To obtain cross-sectional images of vessels and cavities (e.g., a vessel, an esophagus, or at least one nasal cavity), the optical probe can be rotated using a fiber optic rotary joint (FORJ). Furthermore, by simultaneously translating the optical probe longitudinally while rotating, helical scan pattern images can be obtained. This translation can be performed by pulling the tip of the probe back toward the proximal end, and is referred to as pullback. While particular vessels, cavities, or other targets, samples, or objects (e.g., coronary arteries) may be discussed herein, this does not limit the targets, samples, or objects with which features of the present disclosure may be used. Furthermore, although this specification may discuss imaging modalities that may be used in combination (e.g., an intravascular OCT-fluorescence system), this does not limit the imaging modalities that may be used with one or more features of the present disclosure.

[0054] In one or more embodiments, the optical system may include an interference optical system and one or more detectors, wherein the interference optical system (i) receives light from a light source and splits the light into a first light that travels along a sample arm of the interference optical system and is irradiated onto an object or sample and a second reference light, (ii) sends the second reference light along a reference arm of the interference optical system and reflects it off a reference reflection of the interference optical system, and (iii) combines or recombines the reflected or scattered light of the first light irradiated onto the object or sample and the reflected second reference light to generate an interfering light that produces one or more interference fringes, and the one or more detectors are operative to continuously acquire the interfering light and / or the one or more interference fringes and measure the interference between the combined or recombined light or the one or more interference fringes to obtain data related to one or more imaging modalities. The wavelength of the first light is shorter than the wavelength of the reflected or scattered light and / or shorter than the wavelength of the generated interfering light, and the interference optical system or a probe of the interference optical system is photobleached. In one or more embodiments, the interference optics or the probe of the interference optics may comprise a double-clad fiber. In one or more embodiments, the emission intensity of the photobleached interference optics or the photobleached probe may stabilize to within 10% of the average intensity over a predetermined or set period of time (e.g., 2 minutes, about 2 minutes, a time period ranging from 1 minute to 2 minutes, a time period ranging from about 1 minute to about 2 minutes, etc.).

[0055] In one or more embodiments, the one or more imaging modalities may include one or more of optical coherence tomography (OCT), single-modality OCT, multi-modality OCT, swept-wavelength OCT, optical frequency domain imaging (OFDI), intravascular ultrasound (IVUS), another luminal imaging modality, near-infrared spectroscopy (NIRS), near-infrared fluorescence (NIRF), near-infrared autofluorescence (NIRAF), near-infrared, fluorescence, and an intravascular imaging modality.

[0056] In one or more embodiments, a method of photobleaching an interference optics system and / or one or more optical probes may include using or providing an excitation laser having a wavelength between 400 nm and 900 nm; coupling the excitation laser to the interference optics system, one or more optical probes, and / or one or more components of the one or more optical probes; and exciting the interference optics system, one or more optical probes, and / or one or more components of the one or more optical probes with the excitation laser for a set or predetermined amount of time or more. In one or more embodiments, the set or predetermined amount of time is 30 minutes or about 30 minutes. In one or more embodiments, a user can set the amount of time for performing photobleaching. In one or more embodiments, the one or more optical probes and / or one or more components of the one or more optical probes (or each) may include or be composed of double-clad fiber. In one or more embodiments, the set or predetermined amount of time for performing excitation may be 24 hours or longer.

[0057] In one or more embodiments, one or more processors may perform or control the photobleaching method. The one or more processors may receive a set or predetermined amount of time to perform photobleaching, or may automatically calculate and set the set or predetermined amount of time (e.g., based on the number of components or structures to be photobleached, based on the size and shape of the structures or the number of components to be photobleached, etc.).

[0058] In one or more embodiments using or including a double-clad fiber, the one or more processors may include, or be used in conjunction with, a core / clad ratio adjustment processor or unit that operates to control the ratio of pump light between the core and clad of the double-clad fiber. In one or more embodiments, the one or more processors are operable to (or the method includes the step of) set or use a clad ratio (e.g., the ratio of the amount of pump light delivered to the clad) of 10% or greater (such that the ratio value of the amount of pump light delivered to the core is 90% or less). In one or more embodiments, the one or more processors are operative to set or use (or the method includes a step of setting or using) the cladding ratio (e.g., the ratio of the amount of pump light sent to the cladding) to be 50%, approximately 50%, or about 50%, so that the ratio value of the amount of pump light sent to the core is 50%, slightly more than 50%, or about 50% (e.g., with a difference of approximately 50% or about 50% in the ratio of the amount of pump light sent to the cladding, the ratio value of the amount of pump light can be slightly more than 50% or about 50% (e.g., if the cladding ratio value is 47% (a difference of 3% below 50%), the core ratio value can be 53% (a difference of 3% above 50%))).

[0059] In one or more embodiments, the photobleaching method may include using a detector and a lens or lens portion that functions to filter the excitation light and transmit its emission to interference optics, one or more optical probes, and / or one or more components of the one or more optical probes.

[0060] In one or more embodiments, the total optical power of the excitation lasers sent to the interference optics, the one or more optical probes, and / or one or more components of the one or more optical probes is any one of the following: the same as the nominal intensity compared to when the excitation lasers are used as part of the system, the interference optics, the one or more optical probes, and / or one or more components of the one or more optical probes, and is at least 0.1 mW; at least two times higher than the nominal intensity, and is at least 0.2 mW or at least 0.5 mW; at least 10 times higher than the nominal intensity, and is at least 1 mW; and / or at least 100 times higher than the nominal intensity, and is at least 10 mW.

[0061] In one or more embodiments, the photobleaching method can be performed using an artificial intelligence structure, such as a convolutional neural network, a generative adversarial network (GAN), a neural network, or other AI structure or feature described herein or other AI network structure known to those skilled in the art. For example, a generator in a generative adversarial network can function to generate images that are highly similar to a ground truth image, such that a classifier in the generative adversarial network cannot distinguish between the generated image (e.g., of the photobleached interferometric optics, the photobleached one or more optical probes, and / or one or more photobleached components of the one or more optical probes; of an estimated tissue type or characteristic; etc.) and the ground truth image (e.g., an image that may represent a photobleaching setting, predetermined, or target / desired amount of photobleaching for the interferometric optics, the one or more optical probes, and / or one or more components of the one or more optical probes; an image that may represent an actual tissue type or characteristic; etc.). A generative adversarial network can include one or more generators and one or more classifiers. Each generator of the generative adversarial network can be operable to estimate photobleaching properties of the interferometry optics, one or more optical probes, and / or one or more components of the one or more optical probes (e.g., using one or more images (e.g., CT images, OCT images, IVUS images, bronchoscopy images, etc.) of the interferometry optics, one or more optical probes, and / or one or more components of the one or more optical probes). Additionally, each classifier of the generative adversarial network can be operable to determine whether the estimated photobleaching properties of the interferometry optics, one or more optical probes, and / or one or more components of the one or more optical probes (e.g., using one or more images (e.g., CT images, OCT images, IVUS images, bronchoscopy images, etc.) of the interferometry optics, one or more optical probes, and / or one or more components of the one or more optical probes) are estimated (or false) or ground truth (or true).In one or more embodiments, each generator of the generative adversarial network can function to estimate a tissue type or characteristic (e.g., using one or more images (e.g., CT images, OCT images, IVUS images, bronchoscopy images, etc.)), and each classifier of the generative adversarial network can function to determine whether each estimated tissue type or characteristic (e.g., using one or more images (e.g., CT images, OCT images, IVUS images, bronchoscopy images, etc.)) is estimated (or false) or ground truth (or true). In one or more embodiments, an AI network such as a GAN or a coherent GAN (cGAN) can receive images as input and obtain or create a photobleach map (e.g., annotated regions representing one or more photobleaching characteristics and / or amounts / levels) for each image of the interferometric optics, the one or more optical probes, and / or one or more components of the one or more optical probes. In one or more embodiments, the AI ​​network can evaluate one or more acquired images (e.g., CT images, OCT images, IVUS images, bronchoscopy images, etc.), one or more virtual images, and one or more ground truth photobleach maps to generate photobleach maps for the one or more images and evaluate the generated photobleach maps. A three-cycle consistent generative adversarial network (3cGAN) can be used to obtain or construct the photobleach maps and / or evaluate the quality of the photobleach maps.

[0062] In one or more embodiments, an artificial intelligence training device using a neural network or other AI-ready network may include a memory and one or more processors in communication with the memory, the one or more processors operable to train one or more models for photobleaching the interferometric optics, one or more optical probes, and / or one or more components of the one or more optical probes. In one or more embodiments of the present disclosure, the device, system, or storage medium may use the AI ​​network, neural network, or other AI-ready network to perform any of the steps or features of the methods described herein.

[0063] The one or more processors may be further operable to perform one or more of the following using one or more neural networks, convolutional neural networks, recurrent neural networks, generative adversarial networks (GANs), consistent generative adversarial networks (cGANs), three-cycle consistent generative adversarial networks (3cGANs), and / or other AI architectures described herein or known to those skilled in the art: loading a trained model (e.g., a model for tissue detection and / or characterization, a model for photobleaching, etc.); selecting a set of angiography frames or other types of image frames, or selecting one or more intravascular images; detecting one or more targets, objects, or samples (or one or more tissues of the target, object, or sample), and / or one or more photobleached interferometric optics, one or more photobleached optical probes, and / or one or more endovascular images; identifying one or more photobleached components of the optical probe; assessing tissue and / or tissue properties and / or assessing photobleaching properties; determining whether the assessment of tissue or tissue properties and / or assessment of photobleaching properties is appropriate given prior knowledge (e.g., vessel position and pullback direction, previous tissue position or property information, target / desired / setting / predetermined photobleaching information or settings, etc.); modifying the assessment results or tissue positions or tissue properties and / or modifying the photobleach assessment results or photobleaching positions or photobleaching properties for each frame; constructing an image based on the tissue or tissue properties and / or based on the photobleaching or photobleaching properties; performing co-registration of the constructed image with one or more intravascular images (e.g., OCT images, two-dimensional (2D) OCT images, etc.);Inserting or overlaying intravascular image data (e.g., indicators or lines used to represent one or more tissue types, indicators or lines (e.g., solid lines) used to represent regions of calcification, indicators or lines (e.g., dashed or dotted lines) used to represent lipids) into the constructed image (e.g., lines can represent boundaries in each intravascular image, and lines or hollow areas can represent regions corresponding to different tissues (e.g., regions of calcification, regions of lipids, etc.), indicators or lines used to represent photobleached regions of the interference optics, one or more optical probes, and / or one or more components of the one or more optical probes, etc.); and / or acquiring or receiving image data during a pullback operation;

[0064] Turning now to the details of the figures, imaging modalities can be displayed in one or more ways as described herein. One or more displays described herein can enable a user of the one or more displays to use, control, and / or enhance multiple imaging techniques or modalities (e.g., OCT, CT, IVUS, NIRF, NIRAF, fluorescence, NIRS, etc.), and can also enable a user to use, control, and / or enhance multiple imaging techniques or modalities simultaneously.

[0065] As illustrated in FIG. 1A , one or more embodiments of visualizing, enhancing, and / or controlling one or more imaging modalities and performing photobleaching, assessing and detecting or identifying one or more tissue types and / or tissue characteristics, and / or performing co-registration of the present disclosure may be involved in one or more predetermined or desired procedures (e.g., performing photobleaching, planning and performing a medical procedure (e.g., percutaneous coronary intervention (PCI)), etc.). For example, system 2 may communicate with an image scanner 5 (e.g., a CT scanner, an X-ray machine, etc.) to request information (e.g., bed positioning) for use in planning and / or performing a medical procedure (e.g., PCI), and when a clinician uses image scanner 5 to obtain information via a patient scan, image scanner 5 may transmit the requested information along with the image to system 2. In some embodiments, one or more angiograms 3 obtained simultaneously or from a previous session are provided for further planning and visualization. System 2 may also communicate with a workstation, such as a picture archiving and communication system (PACS) 4, to send and receive patient images to facilitate and assist in planning and / or performing a medical procedure. Once a plan is created, a clinician may use system 2 in conjunction with medical procedure / imaging device 1 (e.g., an imaging device, an OCT machine, an IVUS machine, a PCI machine, an ablation machine, a 3D structural construction or reconstruction machine, etc.) to refer to a medical procedure chart or plan and understand the shape and / or size of the target biological object being imaged and / or subjected to the medical procedure. Each of medical procedure / imaging device 1, system 2, locator machine 3, PACS 4, and scanning machine 5 may communicate in any manner known to those skilled in the art, including directly (via a communications network) or indirectly (through one or more of the other machines (e.g., 1 or 5) or additional flash and / or contrast delivery machines; through PACS 4 and one or more of system 2; through clinician interaction; etc.).

[0066] In medical procedures, it is desirable to improve or optimize physiological assessments to determine a particular patient's course of treatment. As at least one example, physiological assessments are highly useful in determining treatment for patients with cardiovascular disease. For example, in a catheterization lab, physiological assessments can be used as a decision-making tool (e.g., whether a patient should undergo a PCI procedure, and whether the PCI procedure was successful). While the concept of utilizing physiological assessments is sound, further adaptation and improvement of physiological assessments for use in clinical settings remains desirable. This situation may be due to the potential need for additional equipment and medications for physiological assessments and / or the potential for physician-to-physician variability in measurement results due to technical issues. Such approaches increase complexity and lack of consistency. Accordingly, one or more embodiments of the present disclosure may employ computational fluid dynamics-based (CFD-based) physiological assessments that can be performed from imaging data to eliminate or minimize technical issues, complexities, and inconsistencies during measurement procedures. To obtain an accurate physiological assessment, the exact 3D structure of the vessel can be reconstructed from the imaging data, as disclosed in U.S. Patent Application Publication No. 2021 / 0077037 (published March 18, 2021, the disclosure of which is incorporated herein by reference in its entirety). Additionally or alternatively, the determination or identification of one or more tissue types and / or tissue characteristics serves to provide additional information for the physiological assessment.

[0067] In at least one embodiment of the present disclosure, a method can be used to provide a more accurate 3D structure compared to using only one imaging modality. In one or more embodiments, a combination of imaging modalities may be used, photobleaching may be performed, one or more characteristics of the photobleaching may be detected, one or more tissue types and / or tissue characteristics may be detected, and co-registration may be processed / performed using artificial intelligence.

[0068] One or more embodiments of the present disclosure may apply machine learning (e.g., deep learning) to, for example, perform photobleaching, detect photobleaching characteristics, and detect one or more tissue types and / or tissue characteristics in image frames without user input to define regions where intravascular imaging pullback occurs. By using artificial intelligence (e.g., deep learning), one or more embodiments of the present disclosure may achieve a higher or highest success rate of photobleaching, photobleaching characteristic detection, and detection of tissue types and / or tissue characteristics from image data without (or with less) user interaction, and may reduce processing and / or prediction times for displaying coregistration results (e.g., when using photobleaching, when detecting photobleaching characteristics, and / or when detecting tissue types and / or tissue characteristics) based on the resulting improved image quality.

[0069] One or more embodiments of the present disclosure can achieve efficient catheter (or other imaging device) photobleaching, photobleaching characteristic detection, tissue type and / or tissue characteristic detection, and / or efficient coregistration results from images. In one or more embodiments, image data can be acquired during intravascular imaging pullback using a catheter (or other imaging device) that can be visualized in the image. In one or more embodiments, the ground truth identifies the location of a catheter or portion of a catheter (or another imaging device or portion of another imaging device). For example, but not by way of limitation, the ground truth may identify photobleached portions of a catheter. In one or more embodiments, the model has sufficient resolution to predict photobleaching and / or tissue type and / or tissue characteristics (e.g., location, size, etc.) in a given image with sufficient accuracy, depending on the application or procedure being performed. Model performance can be further improved by adding more training data. For example, the additional training data can include image annotations that allow a user to label or modify tissue type, tissue characteristic determination, and / or catheter detection in each image.

[0070] In one or more embodiments, an algorithm such as the Viterbi algorithm may be used to detect and / or monitor one or more photobleaching characteristics and / or tissue types or characteristics.

[0071] One or more embodiments may use convolutional neural networks (or other AI structures described herein or known to those skilled in the art) to automate tissue characterization and / or identification of tissue types in images, and may fully automate frame detection for angiograms, intravascular pullbacks, etc., using training (e.g., offline training) and application (e.g., online application) to extract and process frames via deep learning.

[0072] One or more embodiments of the present disclosure may track and / or calculate the success rate of photobleaching, photobleaching characteristics, and / or detecting or identifying tissue types and / or tissue characteristics.

[0073] In at least one further embodiment, a method for 3D reconstruction without additional imaging requirements or conditions may be employed. One or more methods of the present disclosure may use intravascular imaging (e.g., IVUS, OCT, etc.) and one angiographic view. In one or more embodiments, only one image may be used (e.g., a carpet view, a frame of the carpet view, another frame or image type described herein or known to one of skill in the art, etc.). While the intravascular imaging of the present disclosure is not limited to OCT, the following description uses OCT as a representative of intravascular imaging to describe one or more features of the present disclosure.

[0074] Referring to FIG. 1B, a schematic diagram of at least one embodiment of an imaging system 20 for detecting catheter photobleaching or photobleaching characteristics and / or generating an imaging catheter path based on the detected position of the imaging catheter, based on detection or identification of tissue type and / or tissue characteristics, and / or based on a regression line representing the imaging catheter path using image frames simultaneously acquired during intravascular imaging pullback is shown. The embodiment of FIG. 1B can be used in conjunction with one or more of the artificial intelligence features described herein. The imaging system 20 may include an angiography system 30, an intravascular imaging system 40, an image processor 50, a display or monitor 1209, and electrocardiography (ECG) equipment 60. The angiography system 30 may include an X-ray imaging device (e.g., a C-arm 22) connected to an angiography system controller 24 and an angiography image processor 26 to acquire angiography image frames of an object (e.g., any object, sample, blood vessel, target specimen, or object that can be imaged using the size and shape of the imaging device) or patient 106.

[0075] The intravascular imaging system 40 of the imaging system 20 may include a console 32, a catheter 120, and a patient interface unit (PIU) 110 that connects between the catheter 120 and the console 32 to acquire intravascular image frames. The catheter 120 may be inserted into a blood vessel (or into a specimen or other target object, tissue, etc.) of the patient 106. The catheter 120 may function as an optical illuminator and data collection probe that is positioned within the lumen of a particular blood vessel (e.g., a coronary artery) or other type of tissue or specimen. The catheter 120 may include a probe tip, one or more markers or radiopaque markers, an optical fiber, and a torque wire. The probe tip may include one or more data acquisition systems. The catheter 120 may be threaded through an artery of the patient 106 to acquire images of the coronary artery. The patient interface unit 110 may include a motor M therein to enable pullback of the imaging optics during acquisition of intravascular image frames. Images of the blood vessel may be acquired through an imaging pullback procedure. The imaging pullback path can represent a co-registration path, which can be a region of interest or target region of the vessel.

[0076] The console 32 may include a light source 101 and a computer 1200. The computer 1200 may include features as described herein and below (see, e.g., FIGS. 11, 13, etc.), or may be a computer 1200′ (see, e.g., FIGS. 11, 13, etc.) or any other computer or processor described herein. In one or more embodiments, the computer 1200 may include an intravascular system controller 35 and an intravascular image processor 36. The intravascular system controller 35 and / or the intravascular image processor 36 may function to control the motor M in the patient interface unit 110. The intravascular image processor 36 may also perform various steps for image processing and control the information that is displayed.

[0077] Various types of intravascular imaging systems may be used within imaging system 20. Intravascular imaging system 40 is but one example of an intravascular imaging system that may be used within imaging system 20. By way of example, various types of intravascular imaging systems may be used, such as an OCT system, a multi-modality OCT system, an IVUS system, etc.

[0078] Imaging system 20 may also be connected to electrocardiography (ECG) equipment (or other monitoring equipment) 60 to record the electrical activity of the heart (or other monitored organ, monitored tissue, monitored specimen, etc.) over a period of time using electrodes placed on the skin of patient 106. Imaging system 20 may also include an image processor 50 to receive angiography data, intravascular imaging data, and data from ECG equipment 60, perform various image processing steps, and transmit angiography image frames along with coregistration paths to display 1209. Although image processor 50 associated with imaging system 20 appears to be external to both angiography system 20 and intravascular imaging system 30 in FIG. 1B , image processor 50 may be included within angiography system 30, intravascular imaging system 40, display 1209, or a standalone device. Alternatively, image processor 50 may not be required if the various image processing steps are performed using one or more of angiography image processor 26, intravascular image processor 36 of imaging system 20, or other processors described herein (e.g., computer 1200, computer 1200', computer or processor 2, etc.).

[0079] One or more features of an OCT device or system (e.g., an MM-OCT device or system, an SS-OCT device or system, etc.) can be used to collect data that can be used to train one or more neural nets. A plurality (e.g., thousands) of training images can be obtained by collecting a series of OCT images with or without tissue, one or more tissue types, one or more tissue characteristics, etc. In one or more embodiments, the data can be labeled (as verified by a trained operator or user of the device or system) based on whether a photobleaching characteristic is identified or detected, and / or whether a tissue type is identified or detected, whether a tissue characteristic is identified or detected, whether a tissue location is identified or detected, whether multiple tissue types are detected, whether multiple tissue characteristics are detected, etc. In one or more embodiments, after at least 30,000 OCT images have been captured and labeled, the data can be divided into a training population and a test population. In one or more embodiments, the data collection can occur in the same environment or in different environments. For example, a flashlight (or any light source) can be used to shine light onto the barrel of the imaging device without the catheter imaging core during data collection to ensure that false positives do not occur when the physician points the imaging device at external light (e.g., operating room lights, computer screen, etc.) After training is complete, test data can be input into the neural net or neural networks, and the accuracy of the model can be evaluated based on the results of the test data.

[0080] FIG. 2 illustrates at least one embodiment of a catheter 120 that can be used in one or more embodiments of the present disclosure to acquire images and use and / or control multiple imaging modalities to perform photobleaching, identify or detect photobleaching characteristics, and / or identify one or more tissue types and / or tissue characteristics in images or frames with a higher or highest success rate and perform coregistration using the results with a higher or highest efficiency. FIG. 2 illustrates an embodiment of a catheter 120 that includes a sheath 121, a coil 122, a protector 123, and an optical probe 124. As shown schematically in FIGS. 3A-3B and 9A-9C (described below), the catheter 120 may be connected to a patient interface unit (PIU) 110 to spin the coil 122 via a pullback (e.g., at least one embodiment of the PIU 110 functions to spin the coil 122 via a pullback). The coil 122 transmits torque from its proximal end to its distal end (e.g., via or by a rotary motor in the PIU 110). In one or more embodiments, the coil 122 is fixed with / to the optical probe 124, so that the distal tip of the optical probe 124 can also spin to obtain an omnidirectional view of an object (e.g., a biological organ, sample, or material under evaluation (e.g., a hollow organ such as a tube, heart, or coronary artery)). For example, to provide access to difficult-to-access internal organs (e.g., intravascular imaging, the gastrointestinal tract, or other narrow areas), a fiber-optic catheter or endoscope can be placed within the sample arm of the OCT interferometer (e.g., sample arm 103 shown in one or more of Figures 9A-9C, described below). A beam of light passing through the optical probe 124 within the catheter 120 or endoscope is rotated across a surface of interest, resulting in cross-sectional images of one or more objects. To obtain imaging or three-dimensional data, the optical probe 124 simultaneously translates longitudinally while it is rotating, resulting in a helical scan pattern. This linear movement is most commonly accomplished by pulling the tip of the probe 124 back toward the proximal end, and is therefore referred to as pullback.

[0081] The catheter 120, in one or more embodiments, may comprise a sheath 121, a coil 122, a protector 123, and an optical probe 124 as described above (and shown in FIG. 2 ) and may be connected to the PIU 110. In one or more embodiments, the optical probe 124 (which may be an optical probe 124 that has been photobleached using one or more of the photobleaching features of the present disclosure) may comprise a fiber optic connector, an optical fiber, and a distal lens. The fiber optic connector may be used to engage the PIU 110. The optical fiber may function to deliver light to the distal lens. The distal lens may function to shape the light beam, illuminate the light onto an object (e.g., an object 106 (e.g., a tube) described herein), and efficiently collect light from a sample (e.g., an object 106 (e.g., a tube) described herein). In one or more embodiments, the target, sample, or object 106 may be a tube, although the target, sample, or object 106 may be other than (and is not limited to) a tube depending on the particular use or application employed with the catheter 120. A photobleached optical probe can be fabricated / fabricated by performing one or more photobleaching processes on an optical probe. The optical probe may emit background radiation noise (or catheter background noise) when excitation light is coupled into the optical fiber of a catheter (e.g., catheter 120). The intensity of the radiation noise (or background noise) varies depending on the time the excitation light passes through the optical fiber of the catheter (e.g., catheter 120).

[0082] As previously mentioned, in one or more embodiments, the coil 122 delivers torque from its proximal end to its distal end (e.g., via or by a rotary motor in the PIU 110). There may be a mirror at the distal end so that the light beam is deflected outward. In one or more embodiments, the coil 122 is fixed with / to the optical probe 124 so that the distal tip of the optical probe 124 can also spin to provide an omnidirectional view of the object (e.g., a biological organ, sample, or material under evaluation (e.g., a hollow organ such as a tube, heart, or coronary artery)). In one or more embodiments, the optical probe 124 may include a fiber connector at its proximal end and a double-clad fiber and lens at its distal end. The fiber connector functions to interface with the PIU 110. The double-clad fiber can function to deliver and collect OCT light through the core, and in one or more embodiments, can function to collect Raman and / or fluorescence light from an object (e.g., an object 106 (e.g., a tube) described herein, an object and / or a patient (e.g., a tube within a patient), etc.) through the cladding. A lens can be used to focus light onto and / or collect light from an object (e.g., an object 106 (e.g., a tube) described herein). In one or more embodiments, because the size of the core is much smaller than the size of the cladding, scattered light through the cladding is relatively higher than scattered light through the core.

[0083] FIG. 3A illustrates at least one embodiment of a system 100a including an OCT subsystem and a fluorescence subsystem. In one or more embodiments, the OCT subsystem includes a light source (e.g., light source 101), a splitter (e.g., splitter 104; other types of deflection devices, described below, may be used instead of splitter 104), one or more circulators 111, a reference reflection (e.g., reference reflection 105), a combiner (e.g., combiner 113), and at least one detector (e.g., at least one detector 107). The OCT subsystem may be connected to or may include a patient interface unit (e.g., PIU 110) and a catheter 120 that irradiates a sample (e.g., sample 106) with light and receives information in response thereto. In one or more embodiments, the fluorescence subsystem may include a light source for fluorescence (e.g., second light source 101 shown in FIG. 3A) and at least one detector (e.g., second at least one detector 107 shown in FIG. 3A). Additionally, a fluorescence subsystem (e.g., including a second light source 101 and a second at least one detector 107) may be connected to and / or include a patient interface unit (e.g., PIU 110) and a catheter 120 that irradiates a sample (e.g., sample 106) with fluorescence and receives information in response (see FIG. 3A ). For example, in at least one embodiment, OCT light having a wavelength of approximately 1.3 μm emitted from a light source (e.g., light source 101 of the OCT subsystem) may be split by a splitter (e.g., splitter 104) and sent to a reference arm (e.g., reference arm 102) and a sample arm (e.g., sample arm 103). The reference beam is reflected from a reference mirror (e.g., reference mirror 105) in the reference arm (e.g., reference arm 102), and the sample beam is reflected or scattered from the sample through a PIU (patient interface unit) (e.g., PIU 110) and a catheter (e.g., catheter 120) in the sample arm (e.g., sample arm 103). Both beams combine at a combiner (eg, splitter 104 in FIG. 3A, combiner 113 in FIG. 3A, etc.) to produce interference fringes.The output of the interferometer is detected by a detector such as a photodiode, a multi-array camera, or a PMT (e.g., at least one detector 107 shown in FIG. 3A, at least one detector 107 in the OCT subsystem shown in FIG. 3A, etc.). The signal is then transferred to a computer (e.g., computer 2, 1200 shown in FIGS. 1A-3B, 9A-9C, 11, 13, computer 1200' in FIGS. 3A, 12-13, etc.), where signal processing is performed. Interference fringes are generated only when the path length of the sample arm (e.g., sample arm 103) matches the path length of the reference arm (e.g., reference arm 102) within the coherence length of the light source (e.g., light source 101 in FIG. 1B, light source 101 in the OCT subsystem shown in FIG. 3A, etc.). In one or more embodiments, one or more detectors 107 of the OCT subsystem can transmit signals to a first data acquisition unit or processor 109, which can transmit signals to a computer (e.g., computer 1200, computer 1200′, other computers described herein, etc.). In one or more embodiments, one or more detectors 107 of the fluorescence subsystem can transmit signals to a second data acquisition unit or processor 109, which can transmit signals to a computer (e.g., computer 1200, computer 1200′, other computers described herein, etc.).

[0084] In one or more embodiments, the fiber of the PIU (e.g., PIU 110) and the catheter (e.g., the probe of catheter 120) may be made of double-clad fiber (DCF), although this is not limited to double-clad fiber. OCT light can be irradiated onto a sample (e.g., sample 106) through the DCF (e.g., through the core of the DCF), and scattered light from the sample (e.g., sample 106) can be collected via the PIU (e.g., PIU 110) and sent back to a circulator (e.g., circulator 111, the lower or second circulator 111 in FIG. 3A, a circulator of an OCT interferometer, circulator 111 of an OCT subsystem, etc.), and the scattered light can be combined with a reference beam in a combiner (e.g., combiner 113) to generate one or more interference fringes. The output of the OCT interferometer and / or combiner 113 can be detected by one or more OCT detectors (e.g., one or more detectors 107), such as photodiodes, a multi-array camera, or a PMT. The signal can be transferred to a computer (e.g., computer 1200, computer 1200', or any other computer described herein) and signal processing can be performed to generate an OCT image. Interference fringes can only be generated if the path length of the sample arm (e.g., sample arm 103) matches the path length of the reference arm (e.g., reference arm 102) within the coherence length of the light source (e.g., light source 101, light source 101 of the OCT subsystem, etc.).

[0085] For example, excitation light having a wavelength (e.g., any predetermined wavelength from visible light to infrared (IR)), such as 0.633 μm from a light source (e.g., light source 101 of the fluorescence subsystem in FIG. 3A ) or 0.635 μm from a light source (e.g., light source 101 of the fluorescence subsystem in FIG. 3A ), can be transmitted to a sample (e.g., sample 106) through a PIU (e.g., PIU 110) and a catheter (e.g., catheter 120). One or more embodiments of the PIU may be equipped with or include a free-space beam combiner to couple the excitation light into a DCF or other possible / useful fiber common to the OCT. A laser or light may be used as the excitation laser or light, and the excitation laser or light may be irradiated onto the sample (e.g., sample 106) from the distal end of the optical probe of the catheter (e.g., catheter 120). The excitation light may cause the sample (e.g., sample 106) to emit autofluorescence with a broad wavelength range, e.g., from 0.633 μm to 0.80 μm. As another example, a sample (e.g., sample 106) may emit autofluorescence with a broad wavelength range from 0.65 μm to 0.90 μm. In one or more embodiments, a catheter (e.g., catheter 120) may emit Raman scattering at approximately 0.65 μm to 0.75 μm. The autofluorescence and Raman light / signals can be collected by a catheter (e.g., catheter 120 of FIG. 3A) and sent via a PIU (e.g., PIU 110) to a detector (e.g., detector 107 of the fluorescence subsystem of FIG. 3A, a fluorescence detector such as a photomultiplier tube (PMT), etc.). An electrical signal (e.g., an analog electrical signal) at the fluorescence detector 107 can be acquired by a second data acquisition unit or processor 109, and in one or more embodiments, the electrical signal can be acquired when a trigger is detected. Other wavelengths in the visible and NIR are also contemplated. In one or more embodiments, a patient interface unit (PIU; e.g., PIU 110, described below) can include or be equipped with a free-space beam combiner to couple the excitation light into a DCF or other possible / useful fiber common to the OCT. The excitation light can be irradiated onto a sample (e.g., sample 106) from the distal end of an optical probe of a catheter (e.g., catheter or probe 120).

[0086] FIG. 3B illustrates at least one embodiment of a system 100b including an OCT subsystem and a fluorescence subsystem. In one or more embodiments, the OCT subsystem includes a light source (e.g., light source 101), a splitter (e.g., splitter 104; other types of deflection devices, described below, may be used instead of splitter 104), one or more circulators 111, a reference reflection (e.g., reference reflection 105), a combiner (e.g., combiner 113), and at least one detector (e.g., at least one detector 107). The OCT subsystem may be connected to or may include a patient interface unit (e.g., PIU 110) and a catheter 120 that irradiates a sample (e.g., sample 106) with light and receives information in response thereto. In one or more embodiments, the fluorescence subsystem may include a light source for fluorescence (e.g., second light source 101 shown in FIG. 3B) and at least one detector (e.g., second at least one detector 107 shown in FIG. 3B). Additionally, a fluorescence subsystem (e.g., including a second light source 101 and a second at least one detector 107) may be connected to and / or include a patient interface unit (e.g., PIU 110) and a catheter 120 that irradiates a sample (e.g., sample 106) with fluorescence and receives information in response (see FIG. 3B). For example, in at least one embodiment, OCT light having a wavelength of approximately 1.3 μm emitted from a light source (e.g., light source 101 of the OCT subsystem) is split by a splitter (e.g., splitter 104) and sent to a reference arm (e.g., reference arm 102) and a sample arm (e.g., sample arm 103). The reference beam is reflected from a reference mirror (e.g., reference mirror 105) in the reference arm (e.g., reference arm 102), and the sample beam is reflected or scattered from the sample through a PIU (patient interface unit) (e.g., PIU 110) and a catheter (e.g., catheter 120) in the sample arm (e.g., sample arm 103). Both beams combine at a combiner (eg, splitter 104 in FIG. 3B, combiner 113 in FIG. 3B, etc.) to produce interference fringes.The output of the interferometer is detected by a detector, such as a photodiode or a multi-array camera (e.g., at least one detector 107 shown in FIG. 3B, at least one detector 107 in the OCT subsystem shown in FIG. 3B, etc.). The signal is then transferred to a computer (e.g., computer 2, 1200 shown in FIGS. 1A-3B, 9A-9C, 11, and 13, computer 1200′ in FIGS. 3A and 12-13, etc.), where signal processing is performed. Interference fringes are generated only when the path length of the sample arm (e.g., sample arm 103) matches the path length of the reference arm (e.g., reference arm 102) within the coherence length of the light source (e.g., light source 101 in FIG. 1B, light source 101 in the OCT subsystem shown in FIG. 3B, etc.).

[0087] For example, excitation light having a wavelength such as 0.633 μm (e.g., any predetermined wavelength from visible light to infrared (IR)) from a light source (e.g., light source 101 of the fluorescence subsystem in FIG. 3B) is transmitted to a sample (e.g., sample 106) through a PIU (e.g., PIU 110) and a catheter (e.g., catheter 120). The excitation light causes the sample (e.g., sample 106) to emit autofluorescence having a broad wavelength range, for example, from 0.633 μm to 0.80 μm. The autofluorescence is collected by the catheter (e.g., catheter 120 of FIG. 3B) and transmitted to a detector (e.g., detector 107 of the fluorescence subsystem in FIG. 3B) via the PIU (e.g., PIU 110). As another example, the sample (e.g., sample 106) may emit autofluorescence having a broad wavelength range from 0.65 μm to 0.90 μm. In one or more embodiments, a catheter (e.g., catheter 120) may emit Raman scattering at approximately 0.65-0.75 μm. The autofluorescence may be collected by a catheter (e.g., catheter 120 of FIG. 3B) and sent via a PIU (e.g., PIU 110) to a detector (e.g., detector 107 of the fluorescence subsystem of FIG. 3B, a fluorescence detector such as a photomultiplier tube (PMT), etc.). Other wavelengths in the visible and NIR are also contemplated. The embodiment of FIG. 3B may include one or more of the aforementioned features of FIG. 3A, and therefore such features will not be discussed further below.

[0088] FIG. 4 illustrates a free-space beam combiner and FORJ configuration according to at least one embodiment of the present disclosure. In one or more embodiments, the FORJ (e.g., FORJ 306) can include a rotor 306a and a stator 306b. In an OCT and fluorescence system (e.g., system 100a of FIG. 3A and / or system 100b shown in FIG. 3B), the stator (e.g., stator 306b of FIG. 4) includes at least two optical fibers, one for OCT and one for excitation (e.g., single-mode fiber 507a of FIG. 4 for OCT light source delivery and light detection; single-mode fiber 507b of FIG. 4 for coupling with excitation light source 107 (e.g., the fluorescence subsystem or part of light source 101 of system 100a of FIG. 3A and / or system 100b of FIG. 3B)). Each fiber has a lens on its beam combiner side (e.g., single-mode fiber 507a is connected to GRIN lens 501a as shown in FIG. 4; multimode fiber 508 is connected to GRIN lens 501d as shown in FIG. 4; single-mode fiber 507b is connected to GRIN lens 501c as shown in FIG. 4; etc.). In one or more embodiments, a PIU (e.g., PIU 110) may have (include) or be connected to a free-space beam combiner, a FORJ, a rotational motor and a motorized linear translation stage, and a catheter connector. In one or more embodiments of a FORJ (e.g., FORJ 306) of the present disclosure, an optical signal can be transmitted uninterrupted while rotating the fiber (e.g., DCF, other fiber described herein or known to those skilled in the art) on the left side (e.g., the side with rotor 306a) along the fiber axis in FIG. 4. FORJ 306 may have a free-space optical beam coupler separating rotor 306a and stator 306b. The rotor (e.g., rotor 306a in FIG. 4) may consist of a double-clad fiber (e.g., double-clad fiber 506) with a fiber connection on the catheter (e.g., catheter 120) side and a lens (e.g., GRIN lens 501b shown in FIG. 4) on the beam combiner side. In one or more embodiments, the rotor or rotator may include a DCF or other fiber with a lens configuration to produce a collimated beam.The fiber connector of the rotor (e.g., rotor 306a) is then connected to an optical probe (e.g., optical probe 124 via catheter 120 shown in FIGS. 2 and 4), and the stator (e.g., stator 306b) is connected to an optical subsystem (as shown schematically in FIG. 4). For example, in at least one embodiment best illustrated schematically in FIG. 4, single-mode fiber 507a is connected to the OCT light source (e.g., light source 101) and detection elements (e.g., at least one detector 107) of the OCT subsystem, multimode fiber 508 is connected to the fluorescence detection elements (e.g., at least one detector 107) of the fluorescence subsystem, and single-mode fiber 507b is connected to the excitation light source (e.g., light source 101) of the optical subsystem. A rotational motor (e.g., rotational motor 139 in FIG. 3B) transmits torque to the rotor (e.g., rotor 306a). Additionally, a motorized linear translation stage is used for pullback, which causes the beam to helically scan through the luminal sample. A catheter connector (e.g., catheter connector 141 shown schematically in FIG. 3B) connects to a catheter (e.g., catheter 120). In one or more embodiments, the rotator or rotor may include or comprise a double-clad fiber with a lens to generate a collimated beam. The rotor may be connected to an optical probe, and the stator may be connected to an optical subsystem. A rotation motor transmits torque to the rotor. Also, as previously mentioned, a motorized linear translation stage can be used for pullback.

[0089] In one or more embodiments, the free-space beam combiner may include a dichroic filter (e.g., dichroic filter 502a described herein) to separate different wavelengths of light (OCT, excitation light, Raman light, and autofluorescence, in one or more embodiments). The beam combiner may include or be equipped with a low-pass or band-pass filter before the Raman and autofluorescence channels to remove excitation light, thereby minimizing excitation light noise in the fluorescence detector (e.g., one or more detectors 107 of the fluorescence subsystem). The cutoff wavelength of the filter (low-pass or band-pass) may be selected from approximately 645-700 nm (although in one or more embodiments, is not limited to this range).

[0090] As best seen in FIG. 4 , OCT light is collimated from single-mode fiber 507a by GRIN lens 501a. The collimated OCT light is coupled via dichroic filter 502a and GRIN lens 501b into the core of double-clad fiber 506 (of rotor 306a). Backscattered OCT light from the sample (e.g., sample 106) returns to rotor 306a (via catheter 120). The light is collimated by GRIN lens 501b and coupled into single-mode fiber 507a. In one or more embodiments (without limitation), because OCT light is delivered via a bidirectional path (e.g., from stator 306b to rotor 306a and from rotor 306a to stator 306b), the magnification factor can be (or is) about 1 to efficiently couple the fibers. In one or more embodiments, a magnification factor of about 1 or 1 can improve or maximize coupling efficiency.

[0091] One or more embodiments of the method for coupling an OCT channel and an excitation channel to a single core of a double-clad fiber at a rotary junction can be used in conjunction with one or more embodiments of the present disclosure. For example, one or more embodiments of the method for coupling an OCT channel and an excitation channel to a single core of a double-clad fiber at a rotary junction can be used as described in U.S. Patent Application Publication No. 2018 / 0348439 (published December 6, 2018), the disclosure of which is incorporated herein by reference in its entirety. One or more features of a rotary joint, rotary junction, FORJ, etc. can be used as described in U.S. Patent Application Publication No. 2018 / 0348439 (published December 6, 2018), the disclosure of which is incorporated herein by reference in its entirety.

[0092] In one or more embodiments, best seen in Figure 4, a dichroic filter 502a can be used to separate the OCT light from the remaining excitation light and fluorescence. A dichroic filter 502b can be used to separate the excitation light and fluorescence. A mirror 504 is used to reflect the excitation light. A long-pass filter 505 can be used to filter back-reflections of the excitation light and / or stray light.

[0093] In one or more alternative embodiments, the free-space beam combiner is disposed within the FORJ, but may be configured similarly to the embodiment shown in FIG. 4 , with the following exceptions: the multimode fiber 508 and GRIN lens 501d can be eliminated, so the stator 306b of the rotary junction 306 in FIG. 4 can include two optical fibers (instead of three), and the stator 306b of the rotary junction 306 can include a double-clad fiber 506 used in conjunction with the GRIN lens 501a (instead of the single-mode fiber 507a shown in FIG. 4 ). The OCT light can pass through the core of the double-clad fiber 506 of the alternative stator 306 and then be collimated by the GRIN lens 501a. In this alternative embodiment, the collimated light is coupled into the core of the double-clad fiber 506 of the rotor 306a. The excitation light (which has a shorter wavelength than the OCT light) is collected and focused by the GRIN lens 501c along the optical path to (or at a predetermined location on) the GRIN lens 501b. The light then predominantly couples into the core of the double-clad fiber 506 in the rotor 306a of the rotary junction 306. In one or more embodiments, the fluorescence from the sample (e.g., sample 106) may be predominantly transmitted through the clad of the double-clad fiber 506 in the rotor 306a. The light may then couple into the clad of the double-clad fiber 506 in the stator 306b. A double-clad fiber coupler may be used either within the PIU 110 or within the imaging subsystem to separate the OCT light and the fluorescence. For example, a dichroic filter 502a may be used to separate the excitation light from the remaining fluorescence and OCT light. The double-clad fiber 506 in the stator 306b may be connected to a core / clad beam splitter that splits the OCT and fluorescence. In this way, since there is no free-space optical fluorescence channel, this configuration can be used as an alternative, if desired, to achieve a simpler and more compact FORJ. Also, the ability to combine the OCT light and the fluorescence light using a common double-clad fiber (e.g., fiber 506) may facilitate fabrication of the beam combiner. In one or more embodiments, fibers other than DCF may be used.The FORJ (e.g., FORJ306′) and / or other features of the FORJ can be used as described in U.S. Patent Application Publication No. 2022 / 0042781 (published February 10, 2022), the disclosure of which is incorporated herein by reference in its entirety. For example, in one or more embodiments, an optical probe can be removably attached to the optical system and / or FORJ (e.g., via a catheter connector) and can perform a catheter disconnection mode or a catheter connection mode to determine disconnection / connection or disconnect / connect the catheter or probe to the optical system and / or FORJ. In one or more embodiments, the mirrors, ferrules, sleeves, and / or epoxies described herein may be optional, and the fiber, lens, and dichroic filter may be used without one or more of the mirrors, ferrules, sleeves, and / or epoxies.

[0094] Descriptions of like-numbered elements present in systems 100, 100', 100" and / or rotary junction 306' that are the same as those features / elements already described (e.g., systems 100a, 100b, rotary junction 306, other systems described herein, etc.) will not be repeated and are incorporated herein by reference in their entirety.

[0095] Figure 5 shows an example of how the radiated noise from an optical probe (e.g., catheter or probe 120) changes when the probe is excited. The intensity drops by about 40% over the first 5 minutes. Because the noise intensity depends on the excitation time, it is difficult to estimate the radiated noise level.

[0096] After processing the photobleached optical probe, the radiated noise level becomes low and stabilizes over time, as shown in Figure 6. The change in radiated noise intensity is within 10% over a 2-minute period.

[0097] To improve the signal-to-noise ratio of the fluorescence detection, the catheter background noise is reduced and stabilized.

[0098] In one or more embodiments, the coil 122 delivers torque from the proximal end of the catheter 120 or optical probe 124 to the distal end with or via a rotary motor 139 of the PIU 110. In one or more embodiments, a mirror may be present at the distal end of the catheter 120 or optical probe 124 to deflect the light beam outward. The coil 122 may be affixed to the optical probe 124 so that the optical probe 124 and / or the distal tip of the catheter 120 also spins to provide an omnidirectional view of the interior surface of the hollow organ (e.g., a tube) or other target, object, or sample 106 being viewed / imaged. The optical probe 124 of the catheter 120 may include a fiber connector (e.g., fiber or catheter connector 141) at the proximal end, a double-clad fiber (e.g., DCF506), and a lens at the distal end. The fiber / catheter connector 141 serves to interface with the PIU 110 (best seen in FIG. 2B ). A double-clad fiber (e.g., DCF506) can be used to transmit and collect OCT light through the core and collect autofluorescence from a sample (e.g., target, object, or sample 106) through the cladding. A lens can be used to focus light onto and / or collect light from the sample (e.g., target, object, or sample 106). In one or more embodiments, because the size of the core is much smaller than the cladding, scattered light through the cladding can be relatively higher than scattered light through the core.

[0099] According to one or more features of the present disclosure, the use of photobleached optical fibers in catheters can minimize and stabilize catheter background noise without loss of fluorescence signal. The intensity of the background noise can vary within 10% over a two-minute period and stabilize. In one or more embodiments, systems employing one or more photobleaching features and / or methods of the present disclosure can increase the signal-to-noise ratio, making such systems more sensitive for detecting weak NIRF / NIRAF signals.

[0100] One or more photobleaching features and / or methods of the present disclosure function to reduce and stabilize optical probe radiation noise (and / or catheter background noise) in optical catheters and endoscopes. The photobleaching process of the present disclosure can be performed on optical probes and / or components of optical probes.

[0101] FIG. 7 illustrates at least one embodiment of a photobleaching process or example of the present disclosure. Excitation light having a wavelength of approximately 0.635 μm can be transmitted or delivered through a single-mode fiber (e.g., single-mode fiber 507a) to a coupler (e.g., double-clad fiber coupler 701). The excitation light is coupled into the core of a double-clad fiber (e.g., DCF 506), and the light is sent to a core / clad ratio adjuster or processor 702. The core / clad ratio adjuster or processor 702 functions to control how much excitation light is sent to the core and clad of the double-clad fiber (e.g., DCF 506), which then functions to deliver the light to the optical probe / optical probe 124 components of the catheter 120. An adapter 703 can be used to facilitate connection to the catheter 120 (which can be interchangeable (e.g., with another catheter 120) or disposable (e.g., by detaching from the adapter 703 after use)). In one or more embodiments, the core / cladding ratio adjuster or processor 702 may include or be connected to any of the processors described herein (e.g., computer or processor 1200, computer or processor 1200′, etc.). The optical probe / components of the optical probe 124 of the catheter 120 emit autofluorescence with a broad wavelength range of 0.65-0.90 μm, and the catheter 120 may also emit Raman scattering at approximately 0.65-0.75 μm. The autofluorescence and Raman signals are transmitted via a double-clad fiber coupler 701 to a detector (e.g., detector 107), such as a photomultiplier tube (PMT) or a photodiode (or other detector described herein). After the double-clad fiber coupler 701, the emission signal is transmitted by a multimode fiber (e.g., multimode fiber 508) to a lensing assembly (e.g., one or more of dichroic filter 502b, long-pass filter 505, lens 501d, etc.) to filter the excitation light. The detected signal can be monitored during one or more photobleaching processes, and a DCF (eg, DCF 506) can be used as the optical fiber for the optical probe 124 of the catheter 120.

[0102] In one or more embodiments, the core / clad ratio adjuster or processor 701 functions to control the excitation light to excite both the core and clad of a double-clad fiber (e.g., DCF506) to efficiently perform photobleaching. In one or more embodiments, for efficient photobleaching, 10% or more of the excitation light can be directed to the clad of the double-clad fiber (e.g., DCF506), with a core-to-clad ratio of approximately 50% or 50% being more efficient and minimizing photobleaching time. In one or more embodiments, the photobleaching period can be 30 minutes or longer to stabilize the radiated noise, and 24 hours or longer to further reduce the radiated noise. After 30 minutes of photobleaching, the photobleached optical probe may stabilize, as shown in FIG. 6. Furthermore, after such a photobleaching process, the radiated noise does not return to its original noise level, as shown, for example, in FIG. 8A. Follow-up photobleaching tests were performed to measure the efficacy of the photobleached fiber, optical probe, and / or catheter (or one or more components thereof) over time. Test results clearly demonstrated that the effectiveness of the photobleaching feature of the present disclosure persisted for 40 days after the photobleaching process. For example, the light intensity of the radiated noise decreased by half within the first 30 minutes of the photobleaching process of the present disclosure, as shown in FIG. 6, while the light power intensity only increased by (i) 5.9% after two days, (ii) 8.1% after one week, and (iii) 13% after one month. Optical probes (e.g., optical probe 124 and / or catheter 120) may be comprised of optical fiber spools so that long lengths of optical fiber can be photobleached simultaneously. Such processing features eliminate the need to perform photobleaching for each optical probe (e.g., optical probe 124 and / or catheter 120), thereby reducing processing time.

[0103] One or more of the photobleaching method features described above can be used with the optical probe / optical probe components (e.g., optical probe 124, catheter 120, any component of catheter 120, etc.). Such photobleaching processes / features can achieve stable optical probe / catheter acquisition with low background radiation noise. Using a photobleached optical probe 124 and / or catheter 120 can achieve a high signal-to-noise ratio fluorescence system.

[0104] Once trained, the neural network can determine or identify one or more tissue types and / or tissue properties (or characterize tissue) using a single image (e.g., a single OCT image, images from different imaging modalities, etc.) and / or determine or identify whether the optical probe 124 and / or catheter 120 (or one or more other portions of the catheter 120) have been photobleached.

[0105] In one or more embodiments, a method of photobleaching an interference optics system and / or one or more optical probes may include: using or providing an excitation laser having a wavelength between 400 nm and 900 nm; coupling the excitation laser to the interference optics system, one or more optical probes, and / or one or more components of the one or more optical probes; and exciting the interference optics system, one or more optical probes, and / or one or more components of the one or more optical probes with the excitation laser for a set or predetermined amount of time or more. In one or more embodiments, the set or predetermined amount of time is 30 minutes or about 30 minutes. In one or more embodiments, a user can set the amount of time for performing photobleaching. In one or more embodiments, the one or more optical probes and / or one or more components of the one or more optical probes (or each) may include or consist of a double-clad fiber. In one or more embodiments, the set or predetermined amount of time for performing excitation may be 24 hours or longer. In one or more embodiments, one or more processors can perform or control the photobleaching method. The one or more processors may receive a set or predetermined amount of time to perform photobleaching, or may automatically calculate and set the set or predetermined amount of time (e.g., based on the number of components or structures to be photobleached, based on the size and shape of the structures or the number of components to be photobleached, etc.).

[0106] 8B illustrates at least one embodiment of a method for photobleaching an optical probe and / or catheter (or one or more components or portions of the optical probe and / or catheter) that can be used in accordance with one or more aspects of the present disclosure. In one or more embodiments, the photobleaching method can include one or more of the following: (i) applying an excitation laser or signal having a wavelength in a predetermined range (e.g., 400-900 nm) to the component or portion of the optical probe and / or catheter for 30 minutes or more (see, e.g., step S801 of FIG. 8B ); (ii) controlling the ratio of the excitation laser or signal between the core and cladding of a double-clad fiber of the optical probe or catheter (see, e.g., step s802 of FIG. 8B ); and (iii) transmitting the optical power of the excitation laser or signal through the component or portion of the optical probe and / or catheter for a predetermined amount of time to achieve lower and more stable background noise and / or a high signal-to-noise ratio (see, e.g., step s803 of FIG. 8B ). In one or more embodiments, data for or resulting from a photobleaching run may be stored in one or more memories or transmitted to one or more processors and / or neural nets (or other AI-enabled or AI-ready networks) for use in AI evaluation / decisions or in conjunction with other techniques or processes described herein. For example, one or more embodiments of the present disclosure may use image processing and machine learning (ML) to automatically identify and locate fully photobleached portions or components of an optical probe and / or catheter, and / or may use AI-related features to control any aspect of photobleaching (e.g., controlling the intensity of the excitation laser or light during photobleaching) based on innovative features of the present disclosure. As previously described, in one or more embodiments, for efficient photobleaching, 10% or more of the excitation light may be directed into the cladding of a double-clad fiber (e.g., DCF506), and a core-to-clad ratio of near 50% or 50% may be achieved to improve efficiency and minimize photobleaching time.In one or more embodiments, the photobleaching period can be approximately 30 minutes or longer to stabilize radiation noise, or 24 hours or longer to further reduce radiation noise. In one or more embodiments, components of the optical probe (e.g., the optical probe 124 and / or the catheter 120) can be optical fiber spools so that long lengths of optical fiber can be photobleached simultaneously. This processing feature eliminates the need to perform photobleaching for each optical probe (e.g., the optical probe 124 and / or the catheter 120), thereby reducing processing time. In one or more embodiments, the method can include the use of a detector and a lens element or component. The lens element or component can function to filter excitation light and pass radiation from the optical probe 124 and / or components of the optical probe 124 or catheter 120. The components of the optical probe 124 and / or the catheter 120 can include or comprise double-clad fiber (e.g., DCF506). The optical power of the excitation laser or light transmitted by the optical probe 124 and / or components of the optical probe 124 and / or catheter 120 may be one or more of the following: (i) an amount equal to or similar to the nominal or predetermined intensity of the power and excitation laser or light used in the probe or system, said amount being at least 0.1 milliwatts (mW); (ii) two times higher than the nominal intensity, at least 0.2-0.5 mW; (iii) ten times higher than the nominal intensity, at least 1 mW; and / or (iv) one to one hundred times higher than the nominal intensity, at least 10 mW. In one or more embodiments, the optical power of the excitation laser or light may be in an amount ranging from at least 0.1 mW to at least 10 mW. In one or more embodiments, the optical power may be greater than 10 mW. In one or more embodiments that use or include a double-clad fiber, the one or more processors may include, or be used in conjunction with, a core / clad ratio adjustment processor or unit that functions to control the ratio of pump light between the core and clad of the double-clad fiber.In one or more embodiments, the one or more processors are operative to set or use (or the method includes a step of setting or using) a cladding ratio (e.g., the ratio of the amount of pump light sent to the cladding) to be 10% or greater (and thus the ratio value of the amount of pump light sent to the core is 90% or less). In one or more embodiments, the one or more processors are operative to set or use (or the method includes a step of setting or using) the cladding ratio (e.g., the ratio of the amount of pump light sent to the cladding) to be 50%, approximately 50%, or about 50%, so that the ratio value of the amount of pump light sent to the core is 50%, slightly more than 50%, or about 50% (e.g., with a difference of approximately 50% or about 50% in the ratio of the amount of pump light sent to the cladding, the ratio value of the amount of pump light can be slightly more than 50% or about 50% (e.g., if the cladding ratio value is 47% (a difference of 3% below 50%), the core ratio value can be 53% (a difference of 3% above 50%))).

[0107] Embodiments of the methods for detecting or identifying and / or imaging one or more tissue types and / or tissue characteristics may be used independently or in combination (e.g., independently from or in combination with the photobleaching features of the present disclosure).

[0108] In one or more embodiments, the model (which in one or more embodiments may be software, a software / hardware combination, or a procedure utilizing one or more machine learning or deep learning algorithms / procedures / processes trained on data to make one or more predictions about future unseen data) has sufficient resolution to predict and / or assess tissue characterization and / or photobleaching estimates and / or photobleaching results with sufficient accuracy, depending on the application or procedure being performed. Model performance can be further improved by subsequently adding more training data and retraining the model to create a new instance of the model with improved or optimized performance. For example, the additional training data can include data based on user input, where the user can identify or modify the location of tissue in an image and / or identify or modify the location and / or amount of photobleaching of the optical probe 124 and / or components of the optical probe 124 and / or catheter 120.

[0109] In one or more embodiments of the present disclosure, one or more methods, medical imaging devices, intravascular ultrasound (IVUS) or optical coherence tomography ("OCT") equipment, imaging systems, and / or computer-readable storage media may be employed to evaluate tissue characterization and / or perform photobleaching using artificial intelligence.

[0110] In one or more embodiments, an artificial intelligence training device using a neural network or other AI-ready network may include a memory and one or more processors in communication with the memory, the one or more processors operable to train a classifier or patch feature extraction and train an AI classifier (e.g., an ML classifier, a DL classifier, etc.). In one or more embodiments of the present disclosure, the device, system, or storage medium may use an AI network, neural network, or other AI-ready network to perform any of the foregoing method steps (e.g., the steps of FIG. 8B and / or other steps described herein).

[0111] The one or more processors may further be operable to perform one or more of the following using one or more neural networks, convolutional neural networks, and / or recurrent neural networks (or other AI-ready or AI-enabled networks): loading a trained model; selecting a set of image frames; evaluating tissue characterization and / or photobleaching; constructing images (e.g., carpet view images (CVI)); performing coregistration and / or photobleaching; overlaying data on images and / or intravascular images (e.g., CVI, OCT images, etc.); and acquiring or receiving image data during a pullback operation.

[0112] In one or more embodiments, the object, target, or sample may include one or more of the following: a vessel; a target specimen or object; one or more tissues; a patient (or a target or tissue within a patient); one or more optical probes and / or catheters; and / or one or more components of an optical probe and / or catheter.

[0113] The one or more processors may further be operable to perform coregistration by coregistrating an acquired or received angiographic image with one or more acquired intravascular images (e.g., optical coherence tomography (OCT) or intravascular ultrasound (IVUS) images or frames) and / or by coregistrating a carpet view (CVI) with one or more intravascular images (e.g., optical coherence tomography (OCT) or intravascular ultrasound (IVUS) images or frames).

[0114] In one or more embodiments, the loaded trained model may be any one or a combination of the following: a random forest model, a support vector machine (SVM) model, a segmentation (classification) model, a segmentation model with pre-processing, a segmentation model with post-processing, an object detection (regression) model, an object detection model with pre-processing, an object detection model with post-processing, a combination of a segmentation (classification) model and an object detection (regression) model, a deep convolutional neural network model, a recurrent neural network model with long-short-term memory that can take into account temporal relationships between images or frames, a model using a feature pyramid that can take into account different image resolutions, a generic algorithm that functions to refine multiple models for improved performance, and / or a model that uses residual learning techniques.

[0115] In one or more embodiments, the one or more processors may be further operable to perform one or more of the steps of FIG. 8B, any of the steps or features associated with FIGS. 1A-8A, 9A-10, 11-17, and / or any combination of steps or features described herein.

[0116] One or more embodiments of the present disclosure may use other artificial intelligence techniques or methods for dividing data into different groups (e.g., training group, validation group, testing group, etc.) to perform training, or may use other artificial intelligence techniques or methods, such as embodiments described in US 2020 / 051615 (filed September 18, 2020, published March 25, 2021 as WO 2021 / 055837) and U.S. Patent Application No. 17 / 761,561 (filed March 17, 2022), both of which are incorporated herein by reference in their entireties. For example, angiographic data and / or endovascular data may be used for training, validation, and / or testing, as appropriate. One or more embodiments of a non-transitory computer-readable storage medium having stored thereon at least one program causing a computer to execute a method for training a model using artificial intelligence may be used in conjunction with any of the methods described herein (e.g., methods for assessing / determining one or more tissue types and / or characteristics), including, for example,

[0117] In one or more embodiments of the present disclosure, an OCT image may be formed in a polar coordinate system from A-lines. Each A-line contains a wealth of information about the imaged object (e.g., clear indications of artifacts from metal objects (e.g., stents, stent struts, guidewires, etc.), such as narrow signal widths and / or sharp rising and falling edges; significant differences in signal intensity and shape of unobstructed soft tissue compared to sheath reflections and other artifacts, such as wide signal widths and gradual falling edges, tissue type and / or tissue characterization, etc.). Each A-line represents a cross-sectional 1D sampling of a target, sample, object, etc. (e.g., a vessel) along a particular field of view angle. As the imaging probe or instrument is rotated (e.g., from about 0 degrees to about 360 degrees, from about 180 degrees to about 360 degrees, about 360 degrees, etc.), the corresponding A-lines form a complete two-dimensional (2D) cross-section of the target, sample, object, etc. (e.g., a tube) in polar coordinates, which are then transformed to Cartesian coordinates to form a tomographic view (tomo-view) image of the cross-section of the target, sample, object, etc. (e.g., a tube).

[0118] In accordance with at least one aspect of the present disclosure, as previously described, one or more additional methods for detecting targets or objects in OCT images are provided herein and described in U.S. Patent Application No. 16 / 414,222 (filed May 16, 2019, and published December 12, 2019 as U.S. Patent Application Publication No. 2019 / 0374109), the entire disclosure of which is incorporated herein by reference. As some examples, preprocessing may include, for example, one or more of the following steps: (1) smoothing the 2D image in polar coordinates (e.g., using a Gaussian filter, as described below, etc.); (2) calculating vertical and / or horizontal gradients using a Sobel operator (e.g., as described elsewhere below); and / or (3) calculating a binary image using Otsu's method. For example, Otsu's method is an automatic image thresholding technique that separates pixels into two classes, foreground and background, by minimizing the intra-class variance between the two classes, and is equivalent to the globally optimal K-means algorithm (see, e.g., https: / / en.wikipedia.org / wiki / Otsu%27s_method). Those skilled in the art will appreciate that in one or more embodiments, preprocessing methods other than Otsu's method (e.g., Jenks optimization) may be used in addition to or instead of Otsu's method.

[0119] As at least one example of a sheath, a polar image (e.g., an OCT polar image) may include a sheath region and a normal field of view (FOV) (e.g., from top to bottom, from top to bottom of the OCT polar image, etc.). In one or more embodiments, the FOV includes a lumen region and edges. Because one or more shapes of the sheath may not be circular (as typically assumed), and the sheath (and therefore the sheath shape) may adhere to or overlap a lumen or guidewire, it may be useful to separate the sheath from other shapes (e.g., lumen, guidewire, tissue, etc.) beforehand.

[0120] As at least one example of calculating / finding peaks and dominant or maximum gradient edges (e.g., per A-line), for example, in one or more embodiments of a luminal OCT image (e.g., a conventional luminal OCT image), soft tissue or other artifacts may be represented on each A-line by one or more peaks with different characteristics. For example, soft tissue may have a broad, bright area beyond the lumen edge, while artifacts may produce a sudden, dark shadow area beyond the edge. Because one or more OCT images have high resolution, transitions between adjacent A-lines may exhibit signals from both peaks. Such signals enable one or more method embodiments or processes to obtain a more accurate location of artifact objects and / or lumen edges. In one or more embodiments, detection of tissue, lumen edges, artifacts, etc. may be performed as described in U.S. Patent Application Publication No. 2021 / 0174125, published June 10, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0121] Additionally or alternatively, in one or more embodiments, principal component analysis and / or local covariance descriptors may be used to detect objects such as tissue and / or to detect, assess, and / or perform photobleaching. Cross-correlation between adjacent images may be used to improve tissue characterization and / or detection results and / or improve photobleaching estimation and / or results. In one or more embodiments, segmentation-based image processing and / or gradient-based edge detection may be employed to improve results.

[0122] In one or more embodiments of the present disclosure, one or more methods or algorithms for performing coregistration and / or imaging may be used, such as those described in U.S. Pat. No. 12,076,177 (issued September 3, 2024), U.S. Patent Publication No. 2022 / 0104786 (issued April 7, 2022), and U.S. Patent Publication No. 2019 / 0029624 (each of which patents and publications is incorporated by reference in its entirety into this specification).

[0123] The information and other features described herein may be applied to other applications (e.g., controlling or varying photobleaching regions of components of the optical probe 124 and / or catheter 120, coregistration, other modalities, etc.). Indeed, the useful applications of the features of this disclosure and the aforementioned applications and patent publications are not limited to the described modalities, images, or medical procedures. Furthermore, depending on the modality, image, or medical procedure involved, one or more control bars may be contoured, curved, or have any other configuration desired or set by the user. For example, in embodiments using a touchscreen described herein, the user may define or create the size and shape of the control bar based on the user moving a pointer, finger, stylus, or other tool on the touchscreen (or by moving a mouse or other input tool or device, regardless of whether a touchscreen is used). For example, in one or more embodiments, a control bar or cursor may be used in targeting regions or components of the optical probe 124 and / or catheter 120 to be photobleached.

[0124] The computer (e.g., console or computer 1200, 1200′) can perform any of the steps (e.g., method steps relating to FIGS. 1A-8A; steps S801-S803 of FIG. 8B; steps S4000-S4003 of FIG. 10, described below, etc.) for any system (e.g., system 20, system 100a, system 100b, system 100, system 100′, system 100″, etc.) manufactured or used.

[0125] In accordance with one or more further aspects of the present disclosure, a benchtop system may be utilized for one or more features of the present disclosure (e.g., for one or more imaging modalities (e.g., angiography, optical coherence tomography (OCT), multi-modality OCT (MM-OCT), near-infrared autofluorescence (NIRAF), near-infrared fluorescence (NIRF), OCT-NIRAF, OCT-NIRF, etc.)) and / or to employ one or more additional features described herein (e.g., including artificial intelligence processes (e.g., machine learning, deep learning, residual learning, artificial intelligence (“AI”) co-registration, tissue detection, tissue characterization, photobleaching, etc.)) according to one or more aspects of the present disclosure.

[0126] FIG. 9A illustrates an OCT system 100 (referred to herein as "system 100") that can be used for one or more imaging modalities, such as angiography, optical coherence tomography (OCT), multi-modality OCT (MM-OCT), near-infrared autofluorescence (NIRAF), near-infrared fluorescence (NIRF), OCT-NIRAF, etc., and / or can be used to employ one or more additional features described herein, such as artificial intelligence processes (e.g., machine learning or deep learning, residual learning, artificial intelligence ("AI") coregistration, tissue characterization, photobleaching) or other processes (e.g., coregistration, tissue detection, tissue characterization, photobleaching) according to one or more aspects of the present disclosure. System 100 includes a light source 101, a reference arm 102, a sample arm 103, a deflected or deflecting portion 108, a reference mirror (also referred to as a “reference reflection,” “reference reflector,” “partially reflecting mirror,” or “partial reflector”) 105, and one or more detectors 107 (which may be connected to a computer 1200). In one or more embodiments, system 100 may include a patient interface device or unit (“PIU”) 110 and a catheter or probe 120 (see, e.g., examples of PIUs and catheters shown in FIGS. 1A-4, 7, and / or 9A-9C), and system 100 may interact with (e.g., via catheter 120 and / or PIU 110) an object 106, a patient (e.g., a patient's blood vessel) 106, a sample, one or more tissues, one or more portions or components of optical probe 124 and / or catheter 120, etc. In one or more embodiments, system 100 includes an interferometer, or an interferometer is defined by one or more components of system 100 (e.g., at least light source 101, reference arm 102, sample arm 103, deflection unit 108, and reference mirror 105).

[0127] FIG. 9B illustrates an example of a system for employing one or more additional features described herein, such as an artificial intelligence process (e.g., machine learning or deep learning, residual learning, artificial intelligence (“AI”), or other AI features described herein) or other process (e.g., coregistration, tissue detection, tissue characterization, photobleaching) according to one or more aspects of the present disclosure, for a system that can utilize one or more imaging modalities, such as angiography, optical coherence tomography (OCT), multi-modality OCT (MM-OCT), near-infrared autofluorescence (NIRAF), near-infrared fluorescence (NIRF), OCT-NIRAF, OCT-NIRF, etc., and / or for benchtop applications, such as ophthalmology applications. Light from a light source 101 is transmitted and split by a deflector 108 to a reference arm 102 and a sample arm 103. In the reference arm 102, a reference beam passes through a length adjuster 904 and reflects from a reference mirror (such as the reference mirror or reference reflection 105 shown in FIG. 9A or similar). Meanwhile, in the sample arm 103, the sample beam is reflected or scattered (e.g., via the PIU 110 and catheter 120) from an object, patient (e.g., the patient's blood vessels), etc. 106. In one embodiment, both beams are combined at deflection unit 108 to produce interference fringes. In one or more embodiments, the beams travel to a combiner 903, which combines both beams via a circulator 901 and deflection unit 108, and the combined beam is sent to one or more detectors (e.g., one or more detectors 107). The output of the interferometer is continuously acquired by one or more detectors (e.g., one or more detectors 107). The electrical analog signals are converted to digital signals and analyzed by a computer (e.g., computer 1200 (see Figures 1B, 3A-3B, and 9A-9C; also shown in Figures 11 and 13 described below), computer 1200' (e.g., Figure 3A, see Figures 12 and 13 described below), computer 2 (see Figure 1A), processors 26, 36, 50 (see Figure 1B), or any other computer or processor described herein).Additionally or alternatively, one or more of the computers, CPUs, processors, etc. described herein may be used to process, control, update, enhance and / or modify one or more of the imaging modalities and / or process related techniques, functions or methods, or process electrical signals as described above.

[0128] The electrical analog signals can be converted to digital signals and analyzed by a computer (e.g., computer 1200 (see FIGS. 1B, 3A-3B, and 9A-9C; also shown in FIGS. 11 and 13 below), computer 1200′ (e.g., FIG. 3A, see FIGS. 12 and 13 below), computer 2 (see FIG. 1A), or any other processor or computer described herein). Additionally or alternatively, one or more of the computers, CPUs, processors, etc. described herein can be used to process, control, update, enhance, and / or modify one or more of the imaging modalities and / or related techniques, functions, or methods, or to process the electrical signals as previously described. In one or more embodiments (see, e.g., FIG. 9B), the sample arm 103 includes the PIU 110 and catheter 120 such that the sample beam is reflected or scattered from an object, patient (e.g., the patient's blood vessels), etc. 106 as described herein. In one or more embodiments, the PIU 110 may include one or more motors (see, e.g., motor M in FIG. 1B ) to control the pullback motion of the catheter 120 (or one or more components thereof) and / or to control the rotation or spin of the catheter 120 (or one or more components thereof). For example, as best seen in FIG. 9B , the PIU 110 may include a pullback motor (PM) and a spin motor (SM) and / or a motion control unit 112 operative to perform the pullback and / or rotation functions using the pullback motor PM and / or the spin motor SM. As described herein, the PIU 110 may include a rotary joint (e.g., rotary joint RJ as shown in FIGS. 9B and 9C ). The rotary joint RJ may be connected to the spin motor SM to enable the catheter 120 to acquire one or more views or images of an object, a patient (e.g., a patient's blood vessels, tissue, etc.), an optical probe 124, and / or a portion or component 106 of the catheter 120.Computer 1200 (e.g., computer 1200′, computer 2, or other computers or processors described herein) can be used to control one or more of pullback motor PM, spin motor SM, and / or motion control unit 112. The OCT system can include one or more of a computer (e.g., computer 1200, computer 1200′, computer 2, or other computers or processors described herein), PIU 110, catheter 120, monitor (e.g., display 1209), etc. One or more embodiments of the OCT system can interact with one or more external systems, such as an angiography system, an external display, one or more hospital networks, an external storage medium, a power source, a bedside controller (which can be connected to the OCT system using, for example, Bluetooth technology or other known methods of wireless communication), etc.

[0129] In one or more embodiments including a deflecting or deflected portion 108 (best seen in Figures 9A-9C), the deflected portion 108 can function to deflect light from the light source 101 into the reference arm 102 and / or the sample arm 103, and then direct light received from the reference arm 102 and / or the sample arm 103 towards at least one detector 107 (e.g., a spectrometer, one or more components of a spectrometer, another type of detector, etc.). In one or more embodiments, the deflected portion (e.g., deflected portion 108 of systems 100, 100′, 100″, and other systems described herein) may include or comprise one or more interferometers or optical interference systems (e.g., circulators, beam splitters, isolators, couplers (e.g., fused fiber couplers), partially cut mirrors with holes, partially cut mirrors with taps, and the like) that function as described herein. In one or more embodiments, the interferometers or optical interference systems may include one or more components of system 100 (or other systems described herein) (e.g., one or more of light source 101, deflected portion 108, rotary junction RJ, PIU 110, catheter 120, and the like). One or more features of at least the above-described configurations of FIGS. 1A-9B (and / or other configurations described below) may be incorporated into one or more systems (e.g., systems 20, 100a, 100b, 100, 100′, 100″, and the like) described herein.

[0130] In accordance with one or more further aspects of the present disclosure, one or more other systems may be utilized in conjunction with one or more of the multiple imaging modalities and associated methods disclosed herein. FIG. 9C illustrates an example of a system 100″ that may utilize one or more multiple imaging modalities, such as angiography, optical coherence tomography (OCT), multi-modality OCT (MM-OCT), near-infrared autofluorescence (NIRAF), near-infrared fluorescence (NIRF), OCT-NIRAF, OCT-NIRF, etc., and / or employ artificial intelligence processes (e.g., machine learning or deep learning, residual learning, artificial intelligence (“AI”) coregistration, tissue detection, tissue characterization, etc.) or other processes (e.g., coregistration, tissue detection, tissue characterization, photobleaching, etc.) and / or related techniques or methods for ophthalmology applications, etc., in accordance with one or more aspects of the present disclosure. FIG. 9C illustrates an exemplary schematic diagram of an OCT-fluorescence imaging system 100″ in accordance with one or more embodiments of the present disclosure. An OCT light source 101 (e.g., at 1.3 μm) is delivered and split by a deflector or deflecting element (e.g., a splitter) 108 into a reference arm 102 and a sample arm 103, generating a reference beam and a sample beam, respectively. The reference beam from the OCT light source 101 is reflected by a reference mirror 105, and the sample beam is reflected or scattered from an object (e.g., an object under examination, an object, a target, a patient, etc.) 106 via a circulator 901, a rotary junction 90 (“RJ”), and a catheter 120. In one or more embodiments, the fiber between the circulator 901 and the reference mirror or reference reflection 105 can be coiled to adjust the length of the reference arm 102 (best seen in FIG. 9C ). The optical fiber in the sample arm 103 can be made of double-clad fiber (“DCF”). Excitation light for fluorescence can be directed into the RJ 90 and the catheter 120 to illuminate the object (e.g., an object under examination, an object, a patient, etc.) 106. Light from the OCT light source 101 can be transmitted through the core of the DCF, while fluorescence emitted from an object (e.g., an object under examination, an object, a target, a patient, etc.) 106 can be collected through the cladding of the DCF.In pullback imaging, the RJ 90 can be moved with a linear stage to achieve a helical scan of the object (e.g., an object under examination, an object, a target, a patient, etc.) 106. In one or more embodiments, the RJ 90 can include any one or more features of an RJ as described herein. Dichroic filters DF1 and DF2 can be used to separate the OCT light from the excitation light and remaining fluorescence. For example (and without limitation to this example), in one or more embodiments, DF1 can be a long-pass dichroic filter with a cutoff wavelength of approximately 1000 nm, allowing the OCT light (which may be longer than the cutoff wavelength of DF1) to pass through DF1, while the fluorescence excitation and emission (which are at wavelengths shorter than the cutoff) are reflected by DF1. In one or more embodiments, for example (and without limitation to this example), DF2 can be a short-pass dichroic filter. The excitation wavelength can be shorter than the fluorescence emission light, such that the excitation light (which has a wavelength shorter than the cutoff wavelength of DF2) can pass through DF2, and the fluorescence emission light is reflected by DF2. In one embodiment, the beams combine at deflection unit 108 to produce interference fringes. In one or more embodiments, the beams travel to a coupler or combiner 903, which combines the beams via circulator 901 and deflection unit 108, and the combined beam is sent to one or more detectors (such as one or more detectors 107; see, for example, the first detector 107 connected to coupler or combiner 903 in FIG. 9C).

[0131] In one or more embodiments, the optical fiber of the catheter 120 may be operated to rotate inside the catheter 120, and the OCT light and excitation light may be emitted from a side angle at the tip of the catheter 120. After interacting with the object or patient 106, the OCT light may be returned (e.g., via a circulator 901 in the sample arm 103) to the OCT interferometer (which may include a coupler or combiner 903) and combined with a reference beam (e.g., via the coupler or combiner 903) to generate interference fringes. The output of the interferometer may be detected by a first detector 107 (which may be a photodiode or a multi-array camera) and then recorded in a computer (e.g., computer 2, computer 1200 shown in FIG. 9C, computer 1200′, or other computers described herein) via a first data acquisition unit or board (“DAQ1”).

[0132] Simultaneously, or at different times, fluorescence intensity can be recorded via a second detector 107 (e.g., a photomultiplier tube) through a second data acquisition unit or board ("DAQ2"). The OCT and fluorescence signals can then be processed by a computer (e.g., computer 2, computer 1200 shown in FIG. 9C, computer 1200', or other computers described herein) to generate an OCT-fluorescence data set 140 (which can include or consist of multiple frames of helical scan data). Each set of frames can include or consist of multiple data elements of co-registered OCT and fluorescence data corresponding to a rotation angle and pullback position.

[0133] In one or more embodiments, any of systems 100a, 100b, 100, 100', 100", or any other system described herein, may be used to perform photobleaching functions (e.g., estimating photobleaching, performing photobleaching, detecting photobleaching results, etc.) on one or more portions or components of optical probe 124 and / or catheter 120 of the respective system or another system.

[0134] The detected fluorescent or autofluorescent signals can be processed (or further processed) as described in U.S. Pat. No. 11,707,186 (issued July 25, 2023, the disclosure of which is incorporated by reference in its entirety) and / or as described in U.S. Pat. No. 10,952,616 (issued March 23, 2021, the disclosure of which is incorporated by reference in its entirety).

[0135] Without being limited to such arrangements, configurations, devices, or systems, one or more embodiments of the devices, apparatus, systems, methods, storage media, GUIs, etc. described herein can be used in conjunction with such devices or systems (e.g., system 20, system 100a, system 100b, system 100, system 100′, system 100″, the devices, devices, or systems of FIGS. 1A-4, 7, and 9A-17, other devices, devices, or systems described herein, etc.) and / or can be used in conjunction with AI-ready networks described herein or known to those skilled in the art. In one or more embodiments, a single user can perform the methods described herein. In one or more embodiments, one or more users can perform the methods described herein. In one or more embodiments, one or more of the computers, CPUs, processors, etc. described herein can be used to process, control, update, enhance, and / or modify one or more of the imaging modalities and / or process related techniques, functions, or methods, or can process electrical signals as described above.

[0136] 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 laser-pumped supercontinuous light source, and / or a fluorescent lamp. The light source 101 may be any light source that provides light that can be dispersed to provide light for imaging, performing control, displaying, modifying, enhancing an imaging modality, composing or reconstructing an image or structure, characterizing tissue, and / or other methods described herein. The light source 101 may be fiber-coupled or free-space-coupled to other components of the devices and / or systems 100a, 100b, 100, 100', 100", the instruments, devices, or systems of FIGS. 1A-4, 7, and 9A-17, or other embodiments described herein. As previously described, the light source 101 may be a swept-source (SS) light source.

[0137] Additionally or alternatively, the one or more detectors 107 may be a linear array, a charge-coupled device (CCD), multiple photodiodes, or some other method of converting light to an electrical signal. The detector 107 may include an analog-to-digital converter (ADC). The one or more detectors may be detectors having the structures shown in one or more of Figures 1A-4, 7, and 9A-17, as described herein.

[0138] According to one or more aspects of the present disclosure, one or more methods for performing imaging are provided herein. FIG. 10 illustrates a flowchart of at least one embodiment of a method for performing imaging. The method may include one or more of the following: (i) splitting light into a first light and a second reference light (see step S4000 in FIG. 10 ); (ii) receiving reflected or scattered light of the first light after the first light travels along a sample arm and illuminates an object (see step S4001 in FIG. 10 ); (iii) receiving the second reference light after the second reference light travels along a reference arm and reflects off a reference reflection (see step S4002 in FIG. 10 ); and (iv) interfering the reflected or scattered light of the first light and the reflected second reference light with each other (e.g., by combining or recombining and then interfering, by interfering, etc.) to generate interference light that produces one or more interference fringes (see step S4003 in FIG. 10 ). One or more methods may further include updating or controlling high frequency components using a low frequency monitor to improve image quality. For example, one or more embodiments may use multiple imaging modalities, associated methods or techniques, or the like to achieve improved image quality. In one or more embodiments, the imaging probe may be connected to one or more systems (e.g., system 100a, system 100b, system 100, system 100′, system 100″, the instruments, devices, or systems of FIGS. 1A-4, 7, and 9A-17, or other systems or devices described herein, etc.) via a connecting member or interface module. For example, when the connecting member or interface module is a rotary junction of the imaging probe, the rotary junction may be at least one of a contact rotary junction, a lensless rotary junction, a lens-based rotary junction, or other rotary junctions known to those skilled in the art. The rotary junction may be a one-channel rotary junction or a two-channel rotary junction. The rotary junction may be or include any of the RJ features described herein (e.g., at least the features shown in FIG. 4).In one or more embodiments, the illumination portion of the imaging probe may be separate from the detection portion of the imaging probe. For example, in one or more applications, probe may refer to an illumination assembly including an illumination fiber (e.g., a single-mode fiber, a GRIN lens, a spacer, a diffraction grating on the polished surface of the spacer, etc.). In one or more embodiments, scope may refer to the illumination portion, which may be surrounded and protected by, for example, a drive cable, a sheath, and a detection fiber (e.g., a multimode fiber (MMF)) around the sheath. In one or more applications, grating coverage is optional for the detection fiber (e.g., MMF). The illumination portion may be connected to a rotary joint and may rotate continuously at video rates. In one or more embodiments, the detection portion may include one or more of a detection fiber, a detector (e.g., one or more detectors 107, a spectrometer, etc.), computer 1200, computer 1200′, computer 2, other computers or processors described herein, etc. The detection fiber may surround the illumination fiber, but the detection fiber may or may not be covered by a diffraction grating, a spacer, a lens, the end of the probe or catheter, etc.

[0139] The one or more detectors 107 can send digital or analog signals to a processor or computer (e.g., an image processor, processor or computer 1200, 1200′ (see, e.g., FIGS. 1B , 3A-3B, 9A-9C, and 11-13), computer 2 (see, e.g., FIG. 1A), other processors or computers described herein, combinations thereof, etc.). The image processor can be a dedicated image processor or a general-purpose processor configured to process images. In at least one embodiment, computer 1200, 1200′, 2, or other processors or computers described herein can be used instead of or in addition to an image processor. In alternative embodiments, the image processor can include an ADC and can receive analog signals from the one or more detectors 107. The image processor can include one or more of a CPU, a DSP, an FPGA, an ASIC, or some other processing circuit. The image processor can include memory for storing images, data, and instructions. The image processor can generate one or more images based on information provided by the one or more detectors 107. A computer or processor described herein (e.g., the processor of the device, apparatus, or system of Figures 1A-4, 7, and 9A-17, computer 1200, computer 1200', computer 2, image processor, and / or other processor described herein, or an AI-ready network or neural network described herein or known to those skilled in the art) may include one or more components described later in this specification (e.g., see Figures 11-13).

[0140] In at least one embodiment, a console or computer 1200, 1200', computer 2, or other computer or processor described herein, etc., functions to control the movement of the RJ via a motion control unit (MCU) 112 or motor M, acquire intensity data from one or more detectors 107, and display the scanned image (e.g., on a monitor or screen, such as the display, screen, or monitor 1209 shown on the console or computer 1200 of any of FIGS. 1B, 3A-3B, 9A-9C, 11, and 13 and / or the console 1200' of FIGS. 1A, computer 2, or other computer or processor described herein, etc., described below). In one or more embodiments, the MCU 112 or motor M functions to vary the RJ motor and / or the speed of the RJ. The motor may be a stepper motor or DC servo motor to control speed and improve positional accuracy (e.g., compared to using no motor, compared to using automated or controlled speed and / or position changing equipment, compared to manual control, etc.).

[0141] The output of one or more components of any of the systems described herein can be acquired by at least one detector 107, such as, for example, a photodiode, photomultiplier tube (PMT), line scan camera, multi-array camera, etc. Electrical analog signals obtained from the output of systems 100a, 100b, 100, 100', 100" and / or their detectors 107, and / or from the instruments, devices, or systems of FIGS. 1A-4, 7, and 9A-17, can be converted to digital signals and analyzed by a computer (e.g., computer 1200, 1200'). In one or more embodiments, light source 101 can be a radioactive source or a broadband light source emitting over a wide range of wavelengths. In one or more embodiments, a Fourier analyzer, including software and electronics, can be used to convert the electrical analog signals into an optical spectrum.

[0142] Unless otherwise noted herein, like numbers refer to like elements. While variations and differences exist between systems, such as system 20, system 100a, system 100b, system 100, system 100', system 100", and other devices, apparatus, or systems described herein, one or more features thereof may be the same or similar to each other (e.g., light source 101 and other components (e.g., console 1200, console 1200', etc.)). One skilled in the art will appreciate that light source 101, motor or MCU 112, RJ, at least one detector 107, and / or one or more other elements of system 100 may function in the same or similar manner as like-numbered elements of one or more other systems (e.g., the devices, apparatus, or systems of FIGS. 1A-4, 7, and 9A-17, system 100', system 100", and other systems described herein). Those skilled in the art will appreciate that alternative embodiments of the devices, apparatus, or systems of FIGS. 1A-4, 7, and 9A-17, system 100′, system 100″, or any other device, apparatus, or system described herein, and / or one or more similarly numbered elements of one of such systems, including other variations as described herein, may function in the same or similar manner as the similarly numbered elements of any of the other systems (or components thereof) described herein. Indeed, system 100 of FIG. 9A and one or more of the devices, apparatus, or systems shown in any of FIGS. 1A-4, 7, and 9B-17 may be used interchangeably. While there are some differences between the embodiments, there are similarities, for example, as described herein. Similarly, console or computer 1200 may be used in one or more systems (e.g., system 100a, system 100b, system 100, system 100', system 100", any of the devices, apparatus, or systems of FIGS. 1A-17, other systems described herein, etc.), and in addition or instead, one or more other consoles or computers (e.g., console or computer 1200', other computers or processors described herein, etc.) may be used.

[0143] One or more embodiments of the present disclosure may include taking multiple views (e.g., OCT images, ring views, tomo views, anatomical views, etc.), and one or more embodiments may highlight or emphasize NIRF and / or NIRAF. In one or more embodiments, two handles may function as endpoints that can delimit color extremes of the NIRF and / or NIRAF data in one or more embodiments. In addition to standard tomographic views, a user may select to display multiple longitudinal views. When connected to an angiography system, the graphical user interface (GUI) may also display angiography images.

[0144] In accordance with one or more aspects of the present disclosure, the features described above are not limited to being displayed or controlled using a particular GUI. In general, the imaging modalities described above can be used in a variety of ways, including with or without one or more features of the described embodiments of the GUI. For example, even if tools or markers for modifying the image view as described above are not presented with the GUI (or with one or more other components of the GUI; in one or more embodiments, the display may be simplified to display settings or desired information to the user), the GUI may still show an OCT image with such tools or markers.

[0145] For example, using a touchscreen, a GUI (or one or more components of the GUI; in one or more embodiments, the display may be simplified to display settings or desired information to the user), and a processor (e.g., processor 2, 1200, 1200′, or other processors described herein), selecting a region of interest and marker location, angle, plane, etc., may, in one or more embodiments, include a single finger press and drag over the area to be selected or changed. A new orientation and view update may be calculated when the finger or pointer is released. In one or more embodiments, the region of interest and / or marker location may be automatically set or selected using the AI ​​and / or processing features of the present disclosure.

[0146] For one or more embodiments using a touchscreen, a selection or change may be made using two simultaneous touch points, and the view may be updated based on a calculation upon release.

[0147] To focus the user's attention, maintain focus, and allow the user to see all relevant information at once, one or more functions may be controlled by one of the imaging modalities, such as an angiography image view or an intravascular image view (e.g., an OCT image view, an IVUS image view, another intravascular imaging modality image view, etc.).

[0148] In one or more embodiments, one imaging modality may be displayed, or multiple imaging modalities may be displayed.

[0149] In one or more embodiments, one or more procedures can be used to select a selected region or region of interest for a view. For example, a single touch on the selected region (e.g., using a touchscreen, using a mouse or other input device to make a selection, etc.) may cause the semicircle (or other geometric shape used for the designated area) to automatically adjust to the selected selected region or region of interest. Two single touch points can function to connect / draw the selected region or region of interest. For example, a user may wish to view a photobleached portion or component of the optical probe 124 and / or catheter 120, and / or may wish to view the object, sample, or target 106.

[0150] There are many ways, both digital and analog, to calculate intensity, viscosity, resolution, etc. (including increasing the resolution of one or more images), use one or more imaging modalities, construct or reconstruct images or structures, detect and / or characterize tissue, perform photobleaching, and / or related methods, as described herein. In at least one embodiment, a computer (e.g., console or computer 1200, 1200′) may be dedicated to controlling and monitoring the imaging devices, systems, methods, and / or storage media described herein (e.g., OCT, single-mode OCT, multimodal OCT, multiple imaging modalities, IVUS imaging modality, another intravascular imaging modality described herein or known to one of skill in the art, etc.).

[0151] The electrical signals used for imaging can be transmitted via cables or wires (e.g., cable or wire 113 (see FIG. 11 )) to one or more processors (e.g., computer or processor 2 (see, e.g., FIG. 1A ), computer 1200 (see, e.g., FIGS. 3A-3B , 9A-9C , 11 , and 13 ), computer 1200′ (see, e.g., FIGS. 3A , 12, and 13 ), etc.) as described below. Additionally or alternatively, in one or more embodiments, the electrical signals can be processed as described above by other computers or processors or components thereof. Computer or processor 2 as shown in FIG. 1A can be used in place of other computers or processors described herein (e.g., computer or processor 1200, 1200′, etc.), and / or computer or processor 1200, 1200′ can be used in place of other computers or processors described herein (e.g., computer or processor 2). That is, the computers or processors described herein are interchangeable and may function to perform any of the features and methods of the imaging modalities described herein (including using, controlling, and modifying one or more GUIs, and / or performing tissue characterization, tissue detection, photobleaching, and co-registration).

[0152] 11 provides various components of a computer system 1200. The computer system 1200 may include a central processing unit (“CPU”) 1201, ROM 1202, RAM 1203, a communication interface 1205, a hard disk (and / or other storage) 1204, a screen (or monitor interface) 1209, a keyboard (or input interface; which may include a mouse or other input device in addition to a keyboard) 1210, and a BUS (or “bus”) or other connection (e.g., connection 1213) between one or more of the aforementioned components (including, for example, to a console, a probe, an imaging device or system, any motors described herein, a light source, etc.). Additionally, the computer system 1200 may comprise one or more of the aforementioned components. For example, computer system 1200 may include a CPU 1201, RAM 1203, an input / output (I / O) interface (e.g., communication interface 1205), and a bus (which may include one or more wires 1213 as a communication system between components of computer system 1200; in one or more embodiments, computer system 1200 and at least its CPU 1201 may communicate with one or more of the aforementioned components of an apparatus or system (e.g., an apparatus or system using one or more imaging modalities and related methods described herein), and one or more other computer systems 1200 may include one or more combinations of the other aforementioned components (e.g., one or more wires 1213 of computer 1200 may connect to other components via wires 113). CPU 1201 is configured to read and execute computer-executable instructions stored on a storage medium. The computer-executable instructions may include instructions for performing the methods and / or calculations described herein. System 1200 may include one or more additional processors in addition to CPU 1201, and such processors, including CPU 1201, may be used for tissue or object characterization, diagnosis, evaluation, imaging, construction or reconstruction, photobleaching, and / or co-registration.System 1200 may further include one or more processors connected via a network connection (e.g., via network 1206). CPU 1201 and any additional processors used by system 1200 may be located within the same telecommunications network or may be located in different telecommunications networks (e.g., execution of the features, functions, techniques, methods, etc. described herein may be remotely controlled).

[0153] The I / O interface or communication interface 1205 provides a communication interface to input / output devices (which may include light sources, spectrometers, microphones, communication cables and networks (wired or wireless), keyboard 1210, mouse (see, e.g., mouse 1211 shown in FIG. 12), touch screen or screen 1209, light pen, etc. The communication interface of the computer 1200 can be connected to other components described herein via wiring 113 (as shown diagrammatically in FIG. 11). The monitor interface or screen 1209 provides a communication interface thereto.

[0154] Any of the methods and / or data of the present disclosure, such as methods for performing tissue or object characterization, diagnosis, inspection, imaging (including enhancing image resolution, performing imaging using one or more imaging modalities, displaying or modifying one or more imaging modalities and associated methods (and / or options or features), etc.), tissue detection, photobleaching, and / or co-registration (using AI features involving one or more thereof), as described herein, can be stored on a computer-readable storage medium. To cause a processor (such as the processor or CPU 1201 of the computer system 1200 described above) to perform the steps of the methods disclosed herein, a commonly used computer-readable and / or writable storage medium may be used (e.g., one or more of a hard disk (e.g., hard disk 1204, magnetic disk, etc.), flash memory, CD, optical disk (e.g., compact disk ("CD"), digital versatile disk ("DVD"), Blu-ray® disk, etc.), magneto-optical disk, random access memory ("RAM") (e.g., RAM 1203), DRAM, read-only memory ("ROM"), distributed computer system storage, memory card or the like (e.g., non-volatile memory card, solid-state drive (SSD) (see SSD 1207 in FIG. 12), other semiconductor memory such as SRAM), any combination thereof, server / database, etc.). The computer-readable storage medium may be a non-transitory computer-readable medium and / or may include all computer-readable media, with the sole exception that in one or more embodiments the computer-readable medium is transitory and carrying a signal. A computer-readable storage medium may include a medium that stores information for a predetermined period of time, a limited period of time, or a short period of time, and / or only in the presence of power, such as random access memory (RAM), register memory, processor cache, etc.Additionally, embodiments of the present disclosure may 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 be more fully referred to as a "non-transitory computer-readable storage medium") to perform one or more functions of the previously described embodiments, and / or by a computer of a system or device that includes one or more circuits (e.g., application-specific integrated circuits (ASICs)) for performing one or more functions of the previously described embodiments, or by a method performed by a computer of a system or device (e.g., by reading and executing computer-executable instructions from a storage medium to perform one or more functions of the previously described embodiments and / or by controlling one or more circuits to perform one or more functions of the previously described embodiments).

[0155] In accordance with at least one aspect of the present disclosure, the methods, systems, and computer-readable storage media associated with the processors (such as the processor of computer 1200 described above) described above can be achieved using suitable hardware, such as those illustrated in the figures. The functionality of one or more aspects of the present disclosure can be realized using suitable hardware, such as that shown in Figure 11. Such hardware can be implemented using any known technology, such as standard digital circuitry, any known processor operable to execute software and / or firmware programs, or one or more programmable digital devices or systems (e.g., programmable read-only memories (PROMs) or programmable array logic devices (PALs)). Additionally, CPU 1201 (shown in FIG. 11), processor or computer 2 (shown in FIG. 1A), and / or computer or processor 1200′ (shown in FIG. 12) may 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., application-specific integrated circuits (ASICs)). Furthermore, various aspects of the present disclosure may be implemented by software and / or programs that can be stored on an appropriate storage medium (e.g., a computer-readable storage medium, hard drive, etc.) or a medium for transport and / or distribution (e.g., a floppy disk, memory chip, etc.). A computer may include a network of separate computers or separate processors for reading and executing computer-executable instructions. Computer-executable instructions may be provided to the computer, for example, from a network or storage medium. A computer or processor (eg, 2, 1200, 1200', etc.) may include the CPU structures described above or may be connected to communicate with such CPU structures.

[0156] As previously mentioned, FIG. 12 illustrates the hardware configuration of an alternative embodiment of a computer or console 1200′ (see also FIG. 13). The computer 1200′ includes a central processing unit (CPU) 1201, a graphics processing unit (GPU) 1215, random access memory (RAM) 1203, a network interface device 1212, an operational interface 1214 (e.g., a universal serial bus (USB)), and memory (e.g., a hard disk drive or solid-state drive (SSD) 1207). The computer or console 1200′ may include a display 1209. The computer 1200′ may be connected to motors, consoles, and other components of the devices or systems described herein via the operational interface 1214 or the network interface 1212 (e.g., via cables or fibers, such as the cable or fiber 113 similar to that shown in FIG. 11). In one or more embodiments, a computer such as the computer 1200′ may include a motor or motion control unit (MCU). The operation interface 1214 is connected to an operation unit such as a mouse device 1211, a keyboard 1210, a touch panel device, etc. The computer 1200' may include two or more of each component.

[0157] The SSD 1207 stores at least one computer program, and the CPU 1201 loads the at least one program into the RAM 1203 and executes the instructions of the at least one program to perform basic input, output, calculation, memory write and memory read processes as well as one or more processes described herein.

[0158] A computer (e.g., computer 2, computer 1200, 1200′) (or other components such as a CPU) can communicate with a motion control unit (MCU), interferometer, spectrometer, detector, etc. to perform imaging and can reconstruct an image from the acquired intensity data. A monitor or display 1209 can display the reconstructed image and other information about the imaging conditions and the object being imaged. The monitor 1209 also provides a graphical user interface for a user to operate any of the systems described herein. An operation unit (e.g., a mouse device 1211, a keyboard 1210, a touch panel device, etc.) inputs operation signals to an operation interface 1214 of the computer 1200′. In response to the operation signals, the computer 1200′ instructs any of the systems described herein to set or change imaging conditions (e.g., to improve image resolution) and to start or end imaging. The light source or laser source, spectrometer, and / or detector may have an interface for communicating with the computer 1200, 1200′ to send and receive status information and control signals.

[0159] As shown in FIG. 13 , one or more processors or computers 1200, 1200′ (or other processors described herein) may be part of a system in which the one or more processors or computers 1200, 1200′ (or other processors described herein) are in communication with other devices (e.g., database 1603, memory 1602 (which may be combined with or replaced by other types of memory described herein or known to those of skill in the art), input device 1600, output device 1601, etc.). In one or more embodiments, one or more models may have been previously trained and stored in one or more locations, such as memory 1602 or database 1603. In one or more embodiments, one or more models and / or data (e.g., training data, test data, validation data, imaging data, etc.) described herein may be input or loaded via a device such as input device 1600. In one or more embodiments, a user may employ input device 1600 (which may be a separate computer or processor, a keyboard such as keyboard 1210, a mouse such as mouse 1211, a microphone, a screen or display 1209 (e.g., a touchscreen or display), or other input device known to those skilled in the art). In one or more system embodiments, input device 1600 may not be used (e.g., if one or more artificial intelligence features herein preclude user interaction). In one or more system embodiments, output device 1601 may receive one or more outputs described herein to perform marker detection, co-registration, photobleaching, and / or other processes described herein. In one or more system embodiments, database 1603 and / or memory 1602 may have output information stored therein (e.g., trained models, detected marker information, image data, test data, validation data, training data, co-registration results, photobleaching results, segmentation model information, object detection / regression model information, combination model information, etc.).However, one or more embodiments may include several types of data stores, memories, storage media, etc., as described above, and such storage media, memories, data stores, etc. may be stored locally or remotely.

[0160] Furthermore, unless otherwise specified, the term "subset" of a corresponding set does not necessarily refer to a subset in the strict sense, but may be equivalent to the corresponding set.

[0161] Although one or more embodiments of the present disclosure include various details regarding neural network model architectures and optimization approaches, one or more embodiments may employ other model architectures, machine learning algorithms, or optimization approaches. One or more embodiments may utilize a combination of hyperparameters. Because data may be domain and application specific, one or more embodiments may employ data capture, selection, annotation, and model evaluation (e.g., computation of loss and validation metrics). In one or more embodiments, the model architecture may be modified and optimized to address various computer vision problems (as described below).

[0162] One or more embodiments of the present disclosure can automatically detect (predict the spatial location of) radiopaque OCT markers in a time series of X-ray images and coregistrate the X-ray images with corresponding OCT images (at least one example of reference points in two different coordinate systems). One or more embodiments can use deep (recurrent) convolutional neural networks, which can significantly improve marker detection, tissue detection, tissue characterization, photobleaching characterization / detection / performance, and image coregistration. One or more embodiments can employ segmentation and / or object / keypoint detection architectures to solve one or more computer vision problems in one or more other application domains. One or more embodiments employ several novel materials or methods to solve one or more computer vision or other problems (e.g., radiopaque OCT marker detection in a time series of X-ray images; tissue detection; tissue characterization; photobleaching, etc.).

[0163] In one or more embodiments, data capture and selection are employed. In one or more embodiments, the data uniquely distinguishes the application from other applications. For example, an image may include a radiopaque marker specifically used in one or more procedures to facilitate computer detection of the marker in one or more images (e.g., x-ray images) and / or tissue detection, characterization, verification, photobleaching, etc. (e.g., added to an OCT capsule; used in a catheter / probe with a marker similar to that of the OCT marker; used in a catheter / probe with a similar or identical marker, even if the catheter / probe utilizes an imaging modality other than OCT, etc.). In one or more embodiments, software devices or features (models) can be coupled to hardware (e.g., an OCT probe, a probe / catheter using an imaging modality other than OCT but using the same or similar marker as that of the OCT probe / catheter, etc.). One or more embodiments can utilize animal data in addition to patient data. Deep learning training can use large amounts of data, which can be difficult to obtain from clinical studies. Including image data from preclinical animal studies in the training set can improve model performance. Model training and evaluation can be highly data-dependent (e.g., how frames are selected (e.g., pullback only), divided into training / validation / test sets, and grouped into batches, as well as the order in which frames, sets, and / or batches are presented to the model, other data described herein, etc.). In one or more embodiments, such parameters can be more important or significant than some of the model's hyperparameters (e.g., batch size, number of convolutional layers, other hyperparameters described herein, etc.).In one or more embodiments, the collection of user annotations can be used after the device / apparatus, system and / or method is introduced to the market, and can be used for post-market surveillance, retraining of models using new data collected (e.g., in clinical use), and / or continuously adaptive algorithms / methods.

[0164] In one or more embodiments, data annotation can be employed. For example, in one or more embodiments, frames acquired during pullback can be labeled with pixels representing marker or tissue detection, characterization, and / or verification, and pixels representing vessels and / or photobleaching at different phases of the procedure / method (e.g., different contrast levels with intravascular contrast).

[0165] In one or more embodiments, the incorporation of prior knowledge can be employed. For example, in one or more embodiments, marker locations may be known within the vessel and / or catheter or probe, tissue locations may be known within the vessel or other type of target, object, or specimen, and photobleached portions and / or components of the optical probe 124 and / or catheter 120 may be known. Thus, simultaneous vessel and marker localization can be used to improve marker detection and / or tissue and / or photobleach detection, characterization, and / or verification. For example, if a marker on the probe or catheter (or catheter or probe) is identified near a target area for tissue detection and characterization, the completeness of tissue identification / detection and / or characterization (e.g., photobleach detection) for that target area can be improved or maximized (compared to a false positive, where tissue may be detected in an area where the probe or catheter (or its marker) is not located). In one or more embodiments, the marker may move within the vessel during pullback, and such prior knowledge can be incorporated into the machine learning algorithm or loss function.

[0166] In one or more embodiments, loss (cost) and evaluation functions / metrics are employed. For example, in one or more embodiments, temporal information can be used to train and evaluate the model. One or more embodiments can evaluate the distance between the prediction and the ground truth on a frame-by-frame basis and consider the trajectory of the prediction over multiple frames in a time series. For example, the distance between the prediction and the ground truth on a frame-by-frame basis can be used to evaluate the photobleaching process of portions or components of the optical probe 124 and / or catheter 120 over time.

[0167] Applying Machine Learning

[0168] In one or more embodiments, the application of machine learning can be utilized, as described in PCT Application PCT / US2020 / 051615 (filed September 18, 2020, published March 25, 2021 as International Publication No. WO2021 / 055837) and U.S. Patent Application Publication No. 2022 / 0346885 (published November 3, 2022), both of which are incorporated by reference in their entireties. For example, at least one embodiment of an overall machine learning process is shown below. i. Create a dataset containing both images and their corresponding ground truth labels. ii. Split the dataset into a training set and a test set. iii. Selecting the model architecture and other hyperparameters. iv. Train the model using the training set. v. Evaluate the trained model using the validation set. vi. Repeat iv and v with the new data set.

[0169] Based on the test results, one or more embodiments may return to steps i and iii.

[0170] In one or more embodiments, one or more models may be used to detect and / or characterize tissue and / or detect and / or characterize photobleaching, such as those described in PCT Application No. PCT / US2020 / 051615 (filed September 18, 2020, published March 25, 2021 as International Publication No. WO2021 / 055837) and U.S. Patent Application Publication No. 2022 / 0346885 (published November 3, 2022), both of which are incorporated by reference in their entireties. For example, in one or more embodiments, a segmentation model, a regression model, a combination thereof, or the like may be used.

[0171] In a regression model, the input may be one or more entire image frames, and the output may be centroid coordinates of radiopaque markers (and target and stationary markers, if necessary / desired) and / or coordinates of portions of the catheter or probe used in determining tissue detection and / or characterization and / or used to determine photobleaching portions or components of the optical probe 124 and / or catheter 120. Additionally or alternatively, in one or more embodiments, the input may include one or more entire image frames (e.g., the constructed CVI images or frames described above), and the output may be data regarding high-texture regions formed by the presence of sharp edges of one or more A-lines representing calcium in the intravascular image and the presence of homogeneously dark regions representing lipids in the input image frames (e.g., CVI images or frames). As illustrated in FIGS. 14-16, for the regression model, example input images are shown on the left side of FIGS. 14-16, and example corresponding output images are shown on the right side of FIGS. 14-16. At least one architecture of a regression model is shown in FIG. 14. In at least the embodiment of FIG. 14 , the regression model may use a combination of one or more convolutional layers 900, one or more max pooling layers 901, and one or more dense fully connected layers 902. The kernel size, number of widths / filters (output size), and stride size shown for each layer are not limited (e.g., in the left convolutional layer of FIG. 14 , the kernel size is 3×3, the number of widths / filters (output size) is 64, and the stride size is 2). In one or more embodiments, a different hyperparameter search using a fixed optimizer and different widths may be performed; at least one example of a convolutional neural network model architecture for this scenario is shown in FIG. 15 .One or more embodiments may use one or more features of the regression model described in "Deep Residual Learning for Image Recognition" to Kaiming He et al., Microsoft Research, December 10, 2015 (https: / / arxiv.org / pdf / 1512.03385.pdf), which is incorporated by reference in its entirety. Figure 16 illustrates at least a further example of a constructed architecture for a regression model.

[0172] Since the output from the segmentation model, in one or more embodiments, is a tissue or photobleach characterization, or a "probability" for each pixel that can be classified as a tissue or photobleach identification / determination, post-processing can be developed after prediction via the trained segmentation model to refine the definition, determination, or localization of the final coordinates of the tissue or photobleach location (or marker location if the marker is part of the catheter) and / or to determine the type and / or characteristics of the tissue or photobleach. One or more embodiments of the semantic segmentation model can be implemented using the One-Hundred Layers Tiramisu method described in "The One Hundred Layers Tiramisu: Fully Convolutional DenseNets for Semantic Segmentation" by Simon Jegou et al., published October 31, 2017 by Montreal Institute for Learning Algorithms (https: / / arxiv.org / pdf / 1611.09326.pdf), which is incorporated herein by reference in its entirety. In one or more embodiments, a segmentation model such as that shown in FIG. 17 may be used. In at least one embodiment, as shown, input 600 of at least one embodiment of a segmentation model method may be utilized to obtain output 605. For example, by applying the One-Hundred Layers Tiramisu method, one or more features (e.g., convolution 601, concatenation 603, transition up 605, transition down 604, dense block 602, etc.) may be employed by slicing the training dataset. While not limited to (or by) these example embodiments, in one or more embodiments, the slice size may be one or more of 100×100, 224×224, or 512×512, with a slice size of 224×224 providing the best performance in one or more experiments conducted.The batch size (of images in a batch) may be one or more of 2, 4, 8, 16, and in one or more experiments conducted, a larger batch size typically results in better performance (e.g., a higher accuracy rate). In one or more embodiments, 16 images / batch may be used. Optimizing all of these hyperparameters depends on the size of the available dataset and the available computer / computing resources. Thus, as more data becomes available, different hyperparameter values ​​can be selected. Furthermore, in one or more embodiments, the step / epoch may be 100, and the epoch may be greater than 1000 (>1000). In one or more embodiments, a convolutional autoencoder (CAE) may be used.

[0173] In one or more embodiments, the hyperparameters may include, but are not limited to, one or more of the following: depth (i.e., number of layers), width (i.e., number of filters), batch size (i.e., number of training images / steps) (which may be >4 in one or more embodiments), learning rate (i.e., a hyperparameter that controls how quickly the neural network weights (coefficients of the regression model) are adjusted with respect to the loss gradient), dropout (i.e., the fraction of neurons (filters) dropped at each layer), and / or optimizer (e.g., an Adam optimizer or a Stochastic gradient descent (SGD) optimizer). In one or more embodiments, other hyperparameters may be fixed or constant values, such as one or more of the following: input size (e.g., 1024 pixels by 1024 pixels, 512 pixels by 512 pixels, another predetermined or determined number or set of values, etc.); epochs (100, 200, 300, 400, 500, another predetermined or determined number, etc.) (for additional training, iterations may be set to 3000 or more); and / or the number of models trained using different hyperparameter configurations (e.g., 10, 20, another predetermined or determined number, etc.).

[0174] One or more of the features described herein may be determined using a convolutional autoencoder, a Gaussian filter, Haralick features, and / or the thickness or shape of a sample or object (e.g., tissue, specimen, patient, target within a patient, photobleached portions or components of the optical probe 124 and / or catheter 120, etc.).

[0175] In one or more embodiments of the present disclosure, machine learning can be used to determine the location of markers, tissue, or photobleaching; determine, detect, or evaluate tissue type and / or characteristics; determine, detect, evaluate, or perform photobleaching characteristics; perform coregistration; and / or perform other features described herein. Machine learning (ML) is a field of computer science that provides processors with learning capabilities through artificial intelligence. Machine learning may involve one or more algorithms that enable a processor or computer to learn from examples and predict new, unseen data points. In one or more embodiments, such one or more algorithms may be stored in at least one memory or storage medium as software or one or more programs that enable the processor or computer to perform the operations of the processes described in the present disclosure.

[0176] Similarly, one or more components of the present disclosure and / or its devices, systems, and storage media and / or methods can be used in conjunction with an optical coherence tomography probe. Such probes can be used in conjunction with OCT imaging systems and photoluminescent devices, as disclosed, for example, in U.S. Pat. Nos. 6,763,261, 7,366,376, 7,843,572, 7,872,759, 8,289,522, 8,676,013, 8,928,889, 9,087,368, 9,557,154, 10,912,462, 9,795,301, 9,332,942, and 10,939,825 to Tearney et al., U.S. Patent Application Publication No. 2014 / 0276011, and International Publication No. WO 2016 / 015052 to Tearney et al. and methods for facilitating multi-modality imaging (e.g., those disclosed in U.S. Pat. No. 7,889,348 to Tearney et al., and in the disclosures directed to multi-modality imaging disclosed in U.S. Pat. Nos. 9,332,942, 9,557,154, 9,795,301, 10,578,422, 11,473,896, and 11,123,047; U.S. Patent Application Publication Nos. 2010 / 0092389 and 2022 / 0241437; and International Publication No. WO 2016 / 144878), each of which patents and patent application publications is incorporated herein by reference in its entirety. As previously mentioned, any feature or aspect of the present disclosure may be used in combination with OCT imaging systems, devices, methods, storage media, or other aspects or features such as those described in U.S. Pat. No. 11,382,516, the entire disclosure of which is incorporated herein by reference in its entirety.

[0177] The present disclosure, and / or one or more components of the devices, systems and storage media thereof, and / or methods thereof, may be used in conjunction with OCT imaging systems and / or catheters and catheter systems (e.g., U.S. Pat. Nos. 9,869,828, 10,323,926, 10,558,001, 10,601,173, 10,606,064, 10,743,749, 10,884,199, 10,895,692, 11,175,126, 11,375,881, 11,406,327, and 11,406,327). ,796,741, and U.S. Patent Publication Nos. 2019 / 0254506, 2020 / 0390323, 2021 / 0121132, 2021 / 0149122, 2021 / 0174125, 2022 / 0040454, 2022 / 0043217, 2022 / 0044428 and 2023 / 0123224, and those disclosed in International Publication WO2021 / 055837, each of which patents and patent publications is incorporated herein by reference in its entirety.

[0178] Additionally, one or more components of the present disclosure, and / or its devices, systems, and storage media (and / or methods) may be used in conjunction with continuum robotic systems and catheters, such as those described in U.S. Patent Application Publication Nos. 2019 / 0105468, 2021 / 0369085, 2020 / 0375682, 2021 / 0121162, 2021 / 0121051, and 2022 / 0040450 (each of which patents and / or patent application publications are incorporated herein by reference in their entirety).

[0179] Although the disclosure herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present disclosure, and are not intended to be limiting thereof. It is to be understood, therefore, that many modifications can be made to the illustrative embodiments, and that other arrangements can be devised without departing from the spirit and scope of the present disclosure. The scope of the following claims should be accorded the broadest interpretation so as to encompass all such modifications and equivalent structures and functions.

Claims

1. a catheter having an optical probe, the optical probe having one or more optical fibers operable to deliver and receive light; 1. A photobleached imaging device comprising: the optical probe or one or more components of the optical probe are photobleached; Imaging equipment.

2. 10. The imaging device of claim 1, wherein the imaging device is one or more of the following: (i) the luminescence intensity of the photobleached one or more components of the optical probe stabilizes to within 10% or about 10% of the average intensity over a predetermined or set period of time; (ii) the luminescence intensity of the photobleached one or more components of the optical probe stabilizes to within 10% or about 10% of the average intensity over a predetermined or configured period of time, and / or the signal-to-noise ratio of the optical probe is increased compared to an optical probe or catheter in which the optical probe has not been photobleached; (iii) the luminescence intensity of the photobleached optical probe and / or one or more photobleached components of the optical probe stabilizes to within 10% or about 10% of the average intensity over a predetermined or set period of time, the predetermined or set period being any one of 2 minutes, about 2 minutes, a period ranging from 1 minute to 2 minutes, and / or a period ranging from about 1 minute to about 2 minutes; and / or (iv) the optical probe includes a double-clad fiber;

3. one or more processors operable to perform a pullback of the optical probe within a catheter and / or acquire one or more images or frames of one or more imaging modalities from the pullback of the optical probe within the catheter; The imaging device of claim 1 further comprising:

4. 4. The imaging device of claim 3, wherein the imaging device is one or more of the following: (i) the imaging device further includes an interference optical system and one or more detectors, wherein the interference optical system (a) receives light from a light source and splits the light into a first light that travels along a sample arm of the interference optical system and is irradiated onto an object or sample, and a second reference light; (b) sends the second reference light along a reference arm of the interference optical system and reflects it at a reference reflection of the interference optical system; and (c) combines or recombines the reflected or scattered light of the first light irradiated onto the object or sample and the reflected second reference light, causing them to interfere with each other to generate interference light that produces one or more interference fringes, and the one or more detectors are operative to continuously acquire the interference light and / or the one or more interference fringes and measure the interference between the combined or recombined light or the one or more interference fringes to obtain data related to the one or more imaging modalities; (ii) the imaging device further comprises an interference optical system and one or more detectors, wherein the interference optical system (a) receives light from a light source and splits the light into a first light that travels along a sample arm of the interference optical system and is irradiated onto an object or sample, and a second reference light; (b) sends the second reference light along a reference arm of the interference optical system and reflects it at a reference reflection of the interference optical system; and (c) combines or recombines the reflected or scattered light of the first light irradiated onto the object or sample and the reflected second reference light, causing them to interfere with each other to generate an interference light that produces one or more interference fringes, and the one or more detectors are operative to continuously acquire the interference light and / or the one or more interference fringes and measure the interference between the combined or recombined light or the one or more interference fringes to obtain data related to the one or more imaging modalities, wherein the wavelength of the first light is shorter than the wavelength of the reflected or scattered light and / or shorter than the wavelength of the generated interference light; and / or (iii) the one or more imaging modalities include one or more of optical coherence tomography (OCT), single-modality OCT, multi-modality OCT, swept-wavelength OCT, optical frequency domain imaging (OFDI), intravascular ultrasound (IVUS), another luminal imaging modality, near-infrared spectroscopy (NIRS), near-infrared fluorescence (NIRF), near-infrared autofluorescence (NIRAF), near-infrared, fluorescence, and / or an intravascular imaging modality.

5. the one or more processors are further operable to: display the one or more images or frames on a display; store the one or more images or frames in a memory; or use the one or more images or frames to train one or more models or AI networks to automatically detect or perform photobleaching and / or automatically acquire one or more images or frames of the one or more imaging modalities; 4. The imaging device of claim 3, wherein the imaging device is one or more of the following: (i) the trained model is one or a combination of the following: a neural net model or neural network model; a deep convolutional neural network model; a recurrent neural network model with long-short-term memory that can take into account temporal relationships between images or frames; a generative adversarial network (GAN) model; a consistent generative adversarial network (cGAN) model; a three-cycle consistent generative adversarial network (3cGAN) model; a model that can take into account temporal relationships between images or frames; a model that can take into account temporal relationships including tissue location and / or photobleach location during pullback in the tube and / or characterization data of tissue and / or photobleach during pullback in the tube; or a model that uses prior knowledge about the procedure and incorporates that prior knowledge into the machine learning algorithm or loss function. models that can incorporate different image resolutions; models that use feature pyramids that can take different image resolutions into account and / or models that use residual learning techniques; segmentation models; segmentation models with post-processing; models with pre-processing; models with post-processing; segmentation models with pre-processing; deep learning or machine learning models; semantic segmentation models or classification models; object detection or regression models; object detection or regression models with pre- or post-processing; combinations of semantic segmentation models and object detection or regression models; models that use iterative segmentation modeling techniques; models that use feature pyramids; generic algorithms that function to improve multiple models to improve performance; and / or models that use iterative object detection or regression modeling techniques; and / or (ii) the one or more processors are further operable to use one or more neural networks or convolutional neural networks to perform one or more of the following: loading a trained model of an image including a photobleach region; performing photobleaching on the optical probe and / or the catheter; determining whether the photobleach region is correct or accurate; determining one or more of the characteristics of one or more objects, targets, or samples in the one or more images or frames; identifying or detecting the one or more objects, targets, or samples; or encoding data into at least one of the one or more images or frames. using image processing and machine learning (ML) or deep learning to automatically identify and locate the photobleached portions or components of the optical probe or catheter; using image processing and machine learning (ML) or deep learning to automatically identify and locate the one or more objects, targets or samples; displaying the results of the photobleach identification / detection or characterization on a display; and / or acquiring or receiving image data during the pullback movement of the optical probe within the catheter.

6. 10. The imaging device of claim 1, further comprising one or more of the following: (i) a light source operable to emit said light; (ii) a light source operable to emit said light, said light acting as an excitation laser or light having a wavelength of 400 nm to 900 nm or 635 nm; (iii) a light source operable to emit said light, said light being emitted as an excitation laser or light and coupled to said optical probe and / or one or more components of said optical probe; (iv) a light source operable to emit said light, said light being emitted as an excitation laser or light that excites said optical probe and / or one or more components of said optical probe for a set or predetermined amount of time or more; and / or (v) a light source operable to emit the light, the light source emitting the light as an excitation laser or light and exciting the optical probe and / or one or more components of the optical probe with the excitation laser or light for a set or predetermined amount of time or more, the set or predetermined amount of time being one or more of: 30 minutes, more than 30 minutes, in a range of 30 minutes to 24 hours, 24 hours, more than 24 hours, an amount of time calculated or set / received by one or more processors of the imaging device or a user of the imaging device, and / or an amount of time calculated or set by the one or more processors of the imaging device or the user of the imaging device based on the size and shape of the objects to be photobleached or the number of components or structures to be photobleached.

7. 10. The imaging device of claim 1, wherein when the optical probe or the one or more components of the optical probe include or are attached to a double-clad fiber, one or more of the following are present: (i) the imaging device further comprises one or more processors, the one or more processors operable to perform pullback of the optical probe within a catheter and / or acquire one or more images or frames of one or more imaging modalities from the pullback of the optical probe; (ii) the imaging device further comprises one or more processors, the one or more processors operable to perform pullback of the optical probe within the catheter and / or acquire one or more images or frames of one or more imaging modalities from the pullback of the optical probe, the one or more processors further comprising, or operable to be used in conjunction with, a core / clad ratio adjustment processor or unit operable to control a ratio of excitation lasers or light for the core and clad of the double-clad fiber; (iii) the imaging device further comprises one or more processors, the one or more processors operable to perform pullback of the optical probe within the catheter and / or acquire one or more images or frames of one or more imaging modalities from the pullback of the optical probe, the one or more processors further comprising, or adapted to be used in conjunction with, a core / clad ratio adjustment processor or unit operable to control a ratio of excitation lasers or light for the core and clad of the double-clad fiber; wherein the ratio is one or more of the following: 10% or more of the pump laser or light is sent to the cladding and the ratio of the amount of the pump laser or light sent to the core is 90% or less; 50% or about 50% of the pump laser or light is sent to the cladding and 50% or about 50% or more of the pump laser or light is sent to the core; 47% is sent to the cladding and 53% is sent to the core; and / or 50% - x% is sent to the cladding and 50% + x% is sent to the core, x% being equal to the difference between 50% and the percentage allocated to the cladding; and / or (iv) the imaging device further comprises a fluorescence subsystem and a subsystem of another imaging modality;

8. a lens portion or one or more lens components operable to filter an excitation laser or light of a light source and transmit radiation to and / or from the optical probe, the catheter, and / or the one or more components of the optical probe and / or the catheter; 10. The imaging device of claim 1, wherein the imaging device is one or more of the following: (i) the one or more components of the optical probe include or comprise double-clad fiber; and / or (ii) The total optical power of the excitation laser or light sent to the optical probe and / or the one or more components of the optical probe is one of the following: the same as the nominal intensity compared to when the excitation laser or light is used as part of a system, the optical probe and / or the one or more components of the optical probe, and is at least 0.1 mW; at least two times higher than the nominal intensity, and is at least 0.2 mW or at least 0.5 mW; at least 10 times higher than the nominal intensity, and is at least 1 mW; and / or at least 100 times higher than the nominal intensity, and is at least 10 mW.

9. 1. A method of photobleaching an optical probe of an imaging device and / or one or more components of said optical probe, comprising: performing photobleaching on the optical probe, the optical probe used in the catheter, and / or one or more components of the optical probe using an excitation laser or light having a wavelength in a predetermined range or value for at least a predetermined or set amount of time, so as to achieve lower and more stable background radiation noise and / or a high signal-to-noise ratio for the optical probe and / or the one or more components of the optical probe; A method comprising:

10. the predetermined range or value is one or more of 400 nm to 900 nm and / or 635 nm; the predetermined or set amount of time is one or more of: 30 minutes, greater than 30 minutes, in a range of 30 minutes to 24 hours, 24 hours, greater than 24 hours, an amount of time calculated or set / received by one or more processors of the imaging device or a user of the imaging device, and / or an amount of time calculated or set by the one or more processors of the imaging device or the user of the imaging device based on the size and shape of the photobleached object or the number of components or structures to be photobleached; 10. The method of claim 9.

11. (i) controlling the ratio of the pump laser or light between the core and cladding of a double-clad fiber of the optical probe and / or the one or more components of the optical probe; and / or (ii) transmitting or coupling optical power of the excitation laser or light into the optical probe and / or the one or more components of the optical probe for the predetermined amount of time to achieve the lower and more stable background radiation noise and / or the high signal-to-noise ratio; The method of claim 9 , further comprising one or more of:

12. 10. The method of claim 9, wherein the method is one or more of the following: (i) the luminescence intensity of the photobleached one or more components of the optical probe or catheter stabilizes to within 10% or about 10% of the average intensity over a predetermined or set period of time; (ii) the luminescence intensity of the photobleached one or more components of the optical probe or catheter stabilizes to within 10% or about 10% of the average intensity over a predetermined or configured period of time, and / or the signal-to-noise ratio of the optical probe or catheter is increased compared to an optical probe or catheter in which the optical probe has not been photobleached; (iii) the method further comprises the step of continuously acquiring the light or excitation light at the photobleached optical probe and / or the one or more photobleached components of the optical probe or the catheter using one or more detectors of the imaging device so that the emission intensity of the photobleached optical probe and / or the one or more photobleached components of the optical probe or the catheter is stable to within 10% or about 10% of the average intensity over a predetermined or set period of time and / or so that the signal-to-noise ratio of the optical probe is increased compared to a non-photobleached optical probe; (iv) the luminescence intensity of the photobleached optical probe and / or one or more photobleached components of the optical probe stabilizes to within 10% or about 10% of the average intensity over a predetermined or set period of time, the predetermined or set period being any one of 2 minutes, about 2 minutes, a period ranging from 1 minute to 2 minutes, and / or a period ranging from about 1 minute to about 2 minutes; and / or (v) the method further comprises using the optical probe while including a double-clad fiber.

13. performing a pullback of the optical probe within a catheter and / or acquiring one or more images or frames of one or more imaging modalities from the pullback of the optical probe; Further comprising:

10. The method of claim 9, wherein the method is one or more of the following: (i) the imaging device further includes an interference optical system and one or more detectors, wherein the interference optical system (a) receives light from a light source and splits the light into a first light that travels along a sample arm of the interference optical system and is irradiated onto an object or sample, and a second reference light; (b) sends the second reference light along a reference arm of the interference optical system and reflects it at a reference reflection of the interference optical system; and (c) combines or recombines the reflected or scattered light of the first light irradiated onto the object or sample and the reflected second reference light, causing them to interfere with each other to generate interference light that produces one or more interference fringes, and the one or more detectors are operative to continuously acquire the interference light and / or the one or more interference fringes and measure the interference between the combined or recombined light or the one or more interference fringes to obtain data related to one or more imaging modalities; (ii) the imaging device further comprises an interference optical system and one or more detectors, wherein the interference optical system (a) receives light from a light source and splits the light into a first light that travels along a sample arm of the interference optical system and is irradiated onto an object or sample, and a second reference light; (b) sends the second reference light along a reference arm of the interference optical system and reflects it at a reference reflection of the interference optical system; and (c) combines or recombines the reflected or scattered light of the first light irradiated onto the object or sample and the reflected second reference light, causing them to interfere with each other to generate an interference light that produces one or more interference fringes, and the one or more detectors are operative to continuously acquire the interference light and / or the one or more interference fringes and measure the interference between the combined or recombined light or the one or more interference fringes to obtain data related to one or more imaging modalities, wherein the wavelength of the first light is shorter than the wavelength of the reflected or scattered light and / or shorter than the wavelength of the generated interference light; and / or (iii) the one or more imaging modalities include one or more of optical coherence tomography (OCT), single-modality OCT, multi-modality OCT, swept-wavelength OCT, optical frequency domain imaging (OFDI), intravascular ultrasound (IVUS), another luminal imaging modality, near-infrared spectroscopy (NIRS), near-infrared fluorescence (NIRF), near-infrared autofluorescence (NIRAF), near-infrared, fluorescence, and / or an intravascular imaging modality.

14. displaying the one or more images or frames on a display, or storing the one or more images or frames in a memory, or using the one or more images or frames to train one or more models or AI networks to automatically detect or perform photobleaching and / or automatically acquire one or more images or frames of the one or more imaging modalities; Further comprising:

14. The method of claim 13, wherein the method is one or more of the following: (i) the trained model is one or a combination of the following: a neural net model or neural network model; a deep convolutional neural network model; a recurrent neural network model with long-short-term memory that can take into account temporal relationships between images or frames; a generative adversarial network (GAN) model; a consistent generative adversarial network (cGAN) model; a three-cycle consistent generative adversarial network (3cGAN) model; a model that can take into account temporal relationships between images or frames; a model that can take into account temporal relationships including tissue location and / or photobleach location during pullback in the tube and / or characterization data of tissue and / or photobleach during pullback in the tube; or a model that uses prior knowledge about the procedure and incorporates that prior knowledge into the machine learning algorithm or loss function. models that can incorporate different image resolutions; models that use feature pyramids that can take different image resolutions into account and / or models that use residual learning techniques; segmentation models; segmentation models with post-processing; models with pre-processing; models with post-processing; segmentation models with pre-processing; deep learning or machine learning models; semantic segmentation models or classification models; object detection or regression models; object detection or regression models with pre- or post-processing; combinations of semantic segmentation models and object detection or regression models; models that use iterative segmentation modeling techniques; models that use feature pyramids; generic algorithms that function to improve multiple models to improve performance; and / or models that use iterative object detection or regression modeling techniques; and / or (ii) the method further includes using one or more neural networks or convolutional neural networks to perform one or more of the following: loading a trained model of an image including a photobleach region; performing photobleaching on the optical probe and / or the catheter; determining whether the photobleach region is correct or accurate; determining one or more of the characteristics of one or more objects, targets, or samples in the one or more images; identifying or detecting the one or more objects, targets, or samples; or overlaying data on at least one of the one or more images. using image processing and machine learning (ML) or deep learning to automatically identify and locate the photobleached portion or component of the optical probe or catheter; using image processing and machine learning (ML) or deep learning to automatically identify and locate the one or more objects, targets or samples; displaying the results of the photobleach identification / detection or characterization on a display; and / or acquiring or receiving image data during the pullback movement of the optical probe.

15. 10. The method of claim 9, further comprising one or more of the following: (i) using said excitation laser or light source operable to emit light; (ii) using the excitation laser or light source operable to emit light, wherein the wavelength of the excitation laser or light is between 400 nm and 900 nm or 635 nm; (iii) using a light source operable to emit the excitation laser or light, the light source emitting the excitation laser or light and coupling the excitation laser or light into the optical probe and / or one or more components of the optical probe; (iv) using a light source operable to emit the excitation laser or light, the light source emitting the excitation laser or light and exciting the optical probe and / or one or more components of the optical probe and / or the catheter with the excitation laser or light for at least the predetermined or set amount of time; and / or (v) using a light source operable to generate the excitation laser or light, the light source generating the excitation laser or light and exciting the optical probe and / or one or more components of the optical probe with the excitation laser or light for at least the predetermined or set amount of time, wherein the predetermined or set amount of time is one or more of: 30 minutes, at least 30 minutes, in a range of 30 minutes to 24 hours, 24 hours, at least 24 hours, an amount of time calculated or set / received by one or more processors of the imaging device or a user of the imaging device, and / or an amount of time calculated or set by the one or more processors of the imaging device or the user of the imaging device based on the size and shape of or the number of components or structures to be photobleached.

16. 10. The method of claim 9, wherein when the optical probe or the one or more components of the optical probe include or are attached to a double-clad fiber, one or more of the following are present: (i) the imaging device further comprises one or more processors, the one or more processors operable to perform pullback of the optical probe within a catheter and / or acquire one or more images or frames of one or more imaging modalities from the pullback of the optical probe; (ii) the imaging device further comprises one or more processors, the one or more processors operable to perform pullback of the optical probe within the catheter and / or acquire one or more images or frames of one or more imaging modalities from the pullback of the optical probe, the one or more processors further comprising, or operable to be used in conjunction with, a core / clad ratio adjustment processor or unit operable to control the ratio of the excitation laser or light for the core and clad of the double-clad fiber; (iii) the imaging device further comprises one or more processors, the one or more processors operable to perform pullback of the optical probe within the catheter and / or acquire one or more images or frames of one or more imaging modalities from the pullback of the optical probe, the one or more processors further comprising, or adapted to be used in conjunction with, a core / clad ratio adjustment processor or unit operable to control a ratio of the excitation laser or light for the core and clad of the double-clad fiber. wherein the ratio is one or more of the following: 10% or more of the pump laser or light is sent to the cladding and the ratio of the amount of the pump laser or light sent to the core is 90% or less; 50% or about 50% of the pump laser or light is sent to the cladding and 50% or about 50% or more of the pump laser or light is sent to the core; 47% is sent to the cladding and 53% is sent to the core; and / or 50% - x% is sent to the cladding and 50% + x% is sent to the core, x% being equal to the difference between 50% and the percentage allocated to the cladding; and / or (iv) the imaging device further comprises a fluorescence subsystem and a subsystem of another imaging modality;

17. using a lens unit or one or more lens components that function to filter the excitation laser or light of a light source and transmit radiation to and / or from the optical probe and / or the one or more components of the optical probe; Further comprising:

10. The method of claim 9, wherein the method is one or more of the following: (i) the one or more components of the optical probe include or comprise double-clad fiber; and / or (ii) The total optical power of the excitation laser or light sent to the optical probe and / or one or more components of the optical probe is any one of the following: the same as the nominal intensity compared to when the excitation laser or light is used as part of a system, the optical probe and / or one or more components of the optical probe, and is at least 0.1 mW; at least two times higher than the nominal intensity, and is at least 0.2 mW or at least 0.5 mW; at least 10 times higher than the nominal intensity, and is at least 1 mW; and / or at least 100 times higher than the nominal intensity, and is at least 10 mW.

18. 1. A computer-readable storage medium having stored thereon at least one program operable to cause one or more processors to execute a method for photobleaching an optical probe, a catheter, and / or one or more components of an imaging device, the method comprising: The method comprises: performing photobleaching on the optical probe and / or one or more components of the optical probe using an excitation laser or light having a wavelength in a predetermined range or value for at least a predetermined or set amount of time so as to achieve lower and more stable background radiation noise and / or a high signal-to-noise ratio for the optical probe and / or the one or more components of the optical probe; 1. A computer-readable storage medium comprising:

Images