Intravascular imaging system with automated calcium analysis and treatment guidance

Abstract

Intravascular imaging systems and methods for making and using intravascular imaging devices are disclosed. An exemplary intravascular imaging device may include a catheter including an imaging device. A processor may be coupled to the catheter. The processor may be configured to process image data received from the imaging device. The processor may be configured to generate a calcium map. The calcium map may include an indicator of calcium depth to a vessel lumen surface, an indicator of calcium distance to a center of the catheter, or both. A display unit may be coupled to the processor. The display unit may be configured to display a display including the calcium map.

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical imaging, and more particularly to intravascular imaging. [Background technology]

[0002] A wide variety of medical devices have been developed for medical applications, such as intravascular applications. Some of these devices include intravascular imaging devices. Methods for intravascular imaging have also been developed. Of these devices and methods, each has certain advantages and disadvantages. There is a continuing need to provide alternative devices and methods. Summary of the Invention

[0003] The present disclosure provides design, material, manufacturing method, and use alternatives for medical devices. An intravascular imaging system is disclosed. The intravascular imaging system includes: a catheter including an imaging device; a processor coupled to the catheter and configured to process image data received from the imaging device; the processor configured to generate a calcium map, the calcium map including an indicator of calcium depth to a vessel lumen surface, an indicator of calcium distance to a center of the catheter, or both; and a display unit coupled to the processor and configured to display a display including the calcium map.

[0004] Alternatively, or in addition to any of the above embodiments, the horizontal axis in the calcium map represents the catheter pullback direction. Alternatively or additionally to any of the above embodiments, the vertical axis of the calcium map represents the angle of rotation of the catheter.

[0005] Alternatively or additionally to any of the above embodiments, the calcium map includes a topographic depiction of the depth of calcium to the vascular luminal surface. Alternatively or additionally to any of the above embodiments, the calcium map includes a topographic depiction of the distance of calcium to the center of the catheter.

[0006] Alternatively or additionally to any of the above embodiments, the calcium map includes a grayscale depiction of the depth of calcium to the vessel luminal surface. Alternatively or additionally to any of the above embodiments, the calcium map includes a grayscale depiction of the distance of the calcium to the center of the catheter.

[0007] Alternatively or additionally to any of the above embodiments, the display includes a cross-sectional representation of a blood vessel. Alternatively or additionally to any of the above embodiments, the cross-sectional representation of the vessel includes representations of one or more treatment devices superimposed on the cross-sectional representation.

[0008] Alternatively or additionally to any of the above embodiments, the representation of the one or more treatment devices includes one or more depictions of the size of a rotational atherectomy device. Alternatively or additionally to any of the above embodiments, the display includes multiple panels corresponding to different time periods during the intervention.

[0009] Alternatively or additionally to any of the above embodiments, the plurality of panels includes a pre-treatment panel, a pre-lesion treatment panel, and a post-treatment panel. Alternatively or additionally to any of the above embodiments, the imaging device includes an intravascular ultrasound device.

[0010] Alternatively or additionally to any of the above embodiments, the imaging device includes an optical coherence tomography device. An intravascular imaging system is disclosed that includes a catheter system including an intravascular imaging device, a processor coupled to the catheter system and configured to process image data received from the intravascular imaging device, the processor configured to generate a calcium map that graphically depicts an indicator of calcium depth to a vessel lumen surface, an indicator of calcium distance to a center of the catheter system, or both, and a display unit coupled to the processor and configured to display a display including the calcium map.

[0011] Alternatively or additionally to any of the above embodiments, the calcium map includes a topographic depiction of the depth of calcium to the vascular luminal surface. Alternatively or additionally to any of the above embodiments, the calcium map includes a topographic depiction of the distance of calcium to the center of the catheter system.

[0012] Alternatively or additionally to any of the above embodiments, the display includes a cross-sectional representation of a blood vessel. Alternatively or additionally to any of the above embodiments, the cross-sectional representation of the vessel includes representations of one or more treatment devices superimposed on the cross-sectional representation.

[0013] Alternatively or additionally to any of the above embodiments, the representation of the one or more treatment devices includes one or more depictions of the size of a rotational atherectomy device. Alternatively or additionally to any of the above embodiments, the display includes multiple panels corresponding to different periods during the intervention, including a pre-treatment panel, a pre-lesion treatment panel, and a post-treatment panel.

[0014] An intravascular imaging system is disclosed that includes a catheter system including an intravascular ultrasound imaging device, a processor connected to the catheter system and configured to process image data received from the intravascular ultrasound imaging device, the processor configured to use artificial intelligence to generate a calcium map that graphically shows an indicator of calcium depth to a vessel lumen surface, an indicator of calcium distance to a center of the catheter system, or both, and a display unit coupled to the processor and configured to display a display including the calcium map.

[0015] An intravascular imaging system is disclosed that includes a catheter including an imaging device, a processor coupled to the catheter, the processor configured to process image data received from the imaging device, and the processor configured to generate a three-dimensional video of a blood vessel.

[0016] Alternatively or additionally to any of the above embodiments, the three-dimensional video is obtained via rendering of the three-dimensional luminal surface or volume. The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. [Brief explanation of the drawings]

[0017] The present disclosure may be more fully understood from the following detailed description considered in conjunction with the accompanying drawings, in which: [Figure 1] 1 is a diagram that schematically depicts an exemplary intravascular imaging system. [Figure 2] 1 is a perspective view of an exemplary intravascular imaging catheter system. [Figure 3] 1 is a side view of a portion of an exemplary intravascular imaging catheter system. [Figure 4] 1 is a flowchart illustrating an exemplary method for processing an image. [Figure 5] 1 is a flowchart illustrating an exemplary method for processing an image. [Figure 6] FIG. 10 illustrates a display of intravascular imaging data. [Figure 7] FIG. 10 illustrates a display of intravascular imaging data. [Figure 8] FIG. 10 illustrates a display of intravascular imaging data. [Figure 9] FIG. 10 illustrates a display of intravascular imaging data. [Figure 10] FIG. 10 illustrates a display of intravascular imaging data. [Figure 11] FIG. 10 illustrates a display of intravascular imaging data. [Figure 12] FIG. 10 illustrates a display of intravascular imaging data. [Figure 13] FIG. 10 illustrates a display of intravascular imaging data. [Figure 14] FIG. 10 illustrates a display of intravascular imaging data. DETAILED DESCRIPTION OF THE INVENTION

[0018] While the present disclosure is amenable to various modifications and alternative forms, specifics of which have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure.

[0019] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values, whether explicitly stated or not, are assumed herein to be modified by the term "about." The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure.

[0020] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its sense, including "and / or," unless the content clearly dictates otherwise.

[0021] It is noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include one or more particular features, structures, and / or characteristics. However, such descriptions do not necessarily imply that all embodiments include the particular feature, structure, and / or characteristic. Additionally, if a particular feature, structure, and / or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, and / or characteristic may also be used in connection with other embodiments, whether or not explicitly described, unless otherwise specified.

[0022] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0023] Intravascular imaging devices that can be inserted into patients have proven diagnostic capabilities for a variety of diseases and disorders. For example, intravascular ultrasound ("IVUS") imaging systems and / or optical coherence tomography ("OCT") imaging systems can be used as imaging modalities to diagnose blocked blood vessels and provide information to assist physicians in selecting and placing stents and other devices to restore or increase blood flow. IVUS / OCT imaging systems can also be used to diagnose atherosclerotic plaques that form at specific locations within blood vessels. IVUS / OCT imaging systems can also be used to determine the presence of a lesion or stenosis within a blood vessel, as well as the nature and extent of that lesion or stenosis. IVUS / OCT imaging systems can also be used to visualize segments of the vascular system that may be difficult to visualize using other intravascular imaging techniques, such as angiography, due to, for example, motion (e.g., a beating heart) or obstruction by one or more structures (e.g., one or more blood vessels not desired to be imaged). IVUS / OCT imaging systems may also be used to monitor or evaluate ongoing intravascular procedures, such as real-time (or near-real-time) angiography and stent placement, etc. Additionally, IVUS / OCT imaging systems may be used to monitor one or more cardiac chambers.

[0024] 1 schematically illustrates an exemplary intravascular imaging system 100. However, other imaging systems, including optical coherence tomography imaging systems, are also contemplated. IVUS imaging system 100 includes a catheter 102 that can be coupled to a processing unit or control module 104. Control module 104 can include, for example, a processor 106, a pulse generator 108, a drive unit 110, and one or more displays or display units 112. In some examples, pulse generator 108 forms electrical pulses that can be input to one or more transducers (312 in FIG. 3 ) disposed within catheter 102.

[0025] For purposes of this disclosure, the term "display" may refer to an electronic device (e.g., a monitor) used for visually representing data, or may refer to the visual representation of data itself. In other words, the term "display" may refer to a hardware device for displaying data, or the term "display" may refer to data displayed on a hardware device. In some instances, it may be convenient to use the phrase "display unit" to refer to a hardware component and the term "display" to refer to the visual / data component displayed on the display unit. However, such terminology need not be strictly adhered to in this disclosure or in the art generally. Those skilled in the art will be able to distinguish between instances when the term "display" refers to a hardware component and instances when the term "display" refers to a visual / data component.

[0026] In some examples, mechanical energy from the drive unit 110 may be used to drive an imaging core (306 in FIG. 3 ) disposed within the catheter 102. In some examples, electrical signals transmitted from one or more transducers (312 in FIG. 3 ) may be input to the processor 106 for processing. In some examples, the processed electrical signals from the one or more transducers (312 in FIG. 3 ) may be displayed as one or more images on one or more display units 112. For example, a scan converter may be used to map scan line samples (e.g., radial scan line samples, etc.) to a two-dimensional Cartesian grid to display one or more images on the one or more display units 112.

[0027] In some examples, processor 106 may also be used to control the functions of one or more of the other components of control module 104. For example, processor 106 may be used to control at least one of the frequency or duration of electrical pulses transmitted from pulse generator 108, the rate of rotation of the imaging core (306 in FIG. 3) by drive unit 110, the speed or length of pullback of the imaging core (306 in FIG. 3) by drive unit 110, or one or more characteristics of one or more images formed on one or more display units 112.

[0028] FIG. 2 is a schematic side view of one embodiment of the catheter 102 of the IVUS imaging system (100 in FIG. 1). The catheter 102 includes an elongate member 202 and a hub 204. The elongate member 202 includes a proximal end 206 and a distal end 208. In FIG. 2, the proximal end 206 of the elongate member 202 is coupled to the catheter hub 204, and the distal end 208 of the elongate member is configured and arranged for percutaneous insertion into a patient. Optionally, the catheter 102 may define at least one flush port, such as flush port 210. The flush port 210 may be defined in the hub 204. The hub 204 may be configured and arranged for coupling to a control module (104 in FIG. 1). In some examples, the elongate member 202 and the hub 204 are formed as a single body. In other examples, the elongate member 202 and catheter hub 204 are formed separately and then assembled together.

[0029] FIG. 3 is a schematic perspective view of one embodiment of the distal end 208 of the elongate member 202 of the catheter 102. The elongate member 202 includes a sheath 302 having a longitudinal axis 303 and a lumen 304. An imaging core 306 is disposed within the lumen 304. The imaging core 306 includes an imaging device 308 coupled to the distal end of a rotatable drive shaft 310 either manually or using a computer-controlled drive mechanism. One or more transducers 312 are attached to the imaging device 308 and may be employed to transmit and receive acoustic signals. The sheath 302 may be formed from any flexible, biocompatible material suitable for insertion into a patient. Examples of suitable materials include, for example, polyethylene, polyurethane, plastic, spiral-cut stainless steel, nitinol hypotubing, or the like, or combinations thereof.

[0030] In some examples, an array of transducers 312 is attached to the imaging device 308, for example, as shown in FIG. 3 . Alternatively, a single transducer may be employed. Any suitable number of transducers 312 can be used. For example, there may be 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 15, 16, 20, 25, 50, 100, 500, 1000, or more transducers. As will be appreciated, other numbers of transducers may also be used. When multiple transducers 312 are employed, the transducers 312 can be configured into any suitable arrangement, including, for example, a circular arrangement, a rectangular arrangement, etc.

[0031] The transducer(s) 312 may be formed from a material capable of converting an applied electrical pulse into a pressure strain on the surface of the transducer(s) 312, and vice versa. Examples of suitable materials include piezoelectric ceramic materials, piezoelectric composites, piezoelectric plastics, barium titanate, lead zirconate titanate, lead metaniobate, polyvinylidene fluoride, and the like. Other transducer technologies include composite materials, single crystal composites, and semiconductor devices (e.g., capacitive micromachined ultrasound transducers (“cMUT”), piezoelectric micromachined ultrasound transducers (“pMUT”), etc.).

[0032] The pressure distortion on the surface of the one or more transducers 312 forms an acoustic pulse of a frequency based on the resonant frequency of the one or more transducers 312. The resonant frequency of the one or more transducers 312 can be affected by the size, shape, and material used to form the one or more transducers 312. The one or more transducers 312 can be formed in any shape suitable for placement within the catheter 102 and for propagating acoustic pulses of a desired frequency in one or more selected directions. For example, the transducers can be disk-shaped, block-shaped, rectangular, elliptical, etc. The one or more transducers can be formed into the desired shape by any process including, for example, dicing, die-and-fill, machining, micromachining, etc.

[0033] As an example, each of the one or more transducers 312 may include a layer of piezoelectric material sandwiched between a matching layer and a conductive backing material formed from an acoustically absorbing material (e.g., an epoxy substrate with tungsten particles). During operation, the piezoelectric layer may be electrically excited, causing the emission of an acoustic pulse.

[0034] The one or more transducers 312 can be used to form radial cross-sectional images of the surrounding space. Thus, for example, if the one or more transducers 312 are disposed within the catheter 102 and inserted into a patient's blood vessel, the one or more transducers 312 can be used to form images of the wall of the blood vessel and the tissue surrounding the blood vessel.

[0035] The imaging core 306 is rotated about the longitudinal axis 303 of the catheter 102. As the imaging core 306 rotates, the one or more transducers 312 emit acoustic signals in different radial directions (e.g., along different radial scan lines). For example, the one or more transducers 312 may emit acoustic signals at regular (or irregular) increments, such as 256 radial scan lines per rotation, etc. It will be understood that other numbers of radial scan lines can be emitted per rotation instead.

[0036] When an emitted acoustic pulse with sufficient energy encounters one or more medial boundaries, such as one or more tissue boundaries, a portion of the emitted acoustic pulse is reflected back to the emitting transducer as an echo pulse. Each echo pulse with sufficient energy to be detected and reaching the transducer is converted to an electrical signal at the receiving transducer. The one or more converted electrical signals are transmitted to a control module (104 in FIG. 1 ), where a processor 106 processes electrical signal characteristics to form a displayable image of the imaged area based at least in part on the collection of information from each of the transmitted acoustic pulses and received echo pulses. In some examples, rotation of the imaging core 306 is driven by a drive unit 110 disposed within the control module (104 in FIG. 1 ). In an alternative embodiment, one or more transducers 312 are fixed in place and do not rotate. In that case, the drive shaft 310 may instead rotate a mirror that reflects acoustic signals to and from the fixed transducer(s) 312 .

[0037] When one or more transducers 312 are rotated about the longitudinal axis 303 of the catheter 102 emitting the acoustic pulses, multiple images can be formed that collectively form a radial cross-sectional image (e.g., a tomographic image) of a portion of the area around the one or more transducers 312, such as the wall of a blood vessel of interest and the tissue surrounding that vessel. The radial cross-sectional images can optionally be displayed on one or more display units 112. At least one of the imaging cores 306 can be rotated manually or using a computer-controlled mechanism.

[0038] The imaging core 306 may also move longitudinally along the blood vessel into which the catheter 102 is inserted, such that multiple cross-sectional images may be formed along the longitudinal length of the blood vessel. During an imaging procedure, one or more transducers 312 may be retracted (e.g., pulled back) along the longitudinal length of the catheter 102. The catheter 102 may include at least one retractable section that can be retracted during pullback of the one or more transducers 312. In some examples, the drive unit 110 drives the pullback of the imaging core 306 into the catheter 102. The pullback distance of the imaging core by the drive unit 110 can be any suitable distance, including, for example, at least 5 cm, 10 cm, 15 cm, 20 cm, 25 cm, or more. Whether the imaging core 306 is moving longitudinally independently of the catheter 102 or not, the entire catheter 102 can be retracted during an imaging procedure.

[0039] A stepper motor may optionally be used to pull back the imaging core 306. The stepper motor may pull back the imaging core 306 a short distance, stop long enough for the one or more transducers 306 to capture an image or series of images before pulling back the imaging core 306 a short distance again, capture another image or series of images again, etc.

[0040] The quality of images produced at different depths from one or more transducers 312 may be affected by one or more factors, including, for example, bandwidth, transducer focus, beam pattern, and frequency of the acoustic pulses. The frequency of the acoustic pulses output from one or more transducers 312 may also affect the penetration depth of the acoustic pulses output from the one or more transducers 312. Generally, as the frequency of the acoustic pulses is lowered, the penetration depth of the acoustic pulses within patient tissue increases. In some examples, the IVUS imaging system 100 operates within a frequency range of 5 MHz to 100 MHz.

[0041] One or more conductors 314 may electrically couple the transducer 312 to the control module 104 (see, e.g., FIG. 1 ), in which case the one or more conductors 314 may extend along the longitudinal length of the rotatable drive shaft 310.

[0042] A catheter 102 having one or more transducers 312 attached to the distal end 208 of the imaging core 308 may be percutaneously inserted into a patient via an accessible blood vessel, such as the femoral artery, femoral vein, or jugular vein, at a site, such as a blood vessel, away from a selected portion of a selected region to be imaged. The catheter 102 may then be advanced through the patient's blood vessels to a selected imaging site, such as a portion of a selected blood vessel.

[0043] An image or image frame (“frame”) can be generated each time one or more acoustic signals are output into the surrounding tissue, and one or more corresponding echo signals are received by the imager 308 and transmitted to the processor 106. Alternatively, an image or image frame can be a composite of scan lines from a full or partial rotation of the imaging core or device. Multiple frames (e.g., a sequence of frames) are acquired over time during any type of movement of the imaging device 308. For example, frames can be acquired during rotation and pullback of the imaging device 308 along the target imaging location. It will be understood that frames can be acquired with or without rotation of the imaging device 308, and with or without pullback. It will also be understood that frames can be acquired using other types of movement procedures in addition to, or instead of, at least one of rotation and pullback of the imaging device 308.

[0044] In some examples, if pullback is performed, the pullback may be at a constant rate, thus providing a tool for potential applications that can calculate longitudinal vessel / plaque measurements. In some examples, the imaging device 308 is pulled back at a constant rate of at least 0.3 mm / s. In some examples, the imaging device 308 is pulled back at a constant rate of at least 0.4 mm / s. In some examples, the imaging device 308 is pulled back at a constant rate of at least 0.5 mm / s. In some examples, the imaging device 308 is pulled back at a constant rate of at least 0.6 mm / s. In some examples, the imaging device 308 is pulled back at a constant rate of at least 0.7 mm / s. In some examples, the imaging device 308 is pulled back at a constant rate of at least 0.8 mm / s.

[0045] In some examples, one or more acoustic signals are output to the surrounding tissue at regular time intervals. In some examples, one or more corresponding echo signals are received by the imager 308 and transmitted to the processor 106 at regular time intervals. In some examples, the resulting frames are generated at regular time intervals.

[0046] At least some conventional IVUS imaging systems display only a single (e.g., cross-sectional, longitudinal, etc.) image during or after an IVUS procedure, such as a pullback procedure. However, it may be beneficial to simultaneously display at least two images in real time during the IVUS procedure (e.g., a pullback procedure), for example, a most recently processed image and a previously acquired image having some particular or selected image characteristic (e.g., maximum or minimum lumen area or diameter).

[0047] Some diagnostic and / or therapeutic interventions may involve analysis of images generated by an IVUS imaging system. However, this analysis may require a significant amount of training / experience to effectively interpret the images. Furthermore, automated analysis and / or evaluation may be difficult due to the high presence of speckles on IVUS images. Disclosed herein are methods for processing and / or analyzing images, such as images generated using / by an IVUS imaging system. Such methods may utilize machine learning, artificial intelligence, deep neural networks, etc. to improve the processing and / or analysis of images generated using / by an IVUS imaging system.

[0048] 4 is a flowchart illustrating an overview or framework of an exemplary process. The process may include generating and / or collecting images of a blood vessel (e.g., IVUS images generated via an IVUS pullback procedure, cross-sectional images, etc.) in box 401. The generated / collected images may undergo cross-sectional analysis in box 403. The cross-sectional analysis may include processing and / or segmenting the images using a deep learning network (e.g., a deep neural network such as a U-Net deep neural network) to obtain image segmentation for quantitative analysis and image classification for automatic identification of lesion type, stent detection, etc. For example, output from the cross-sectional analysis, noted in box 405, may include identification of lumen boundary, identification of lumen dimension, identification of media boundary (e.g., identification of the media boundary of the tunica media within a vessel), identification of media dimension, identification of calcification angle / arc, identification of calcification coverage, identification of lesion type, etc. In addition to identifying such boundaries / dimensions, the output may be displayed on a display unit in an appropriate format (e.g., with words or symbols, as actual or schematic images, graphically, numerically, etc.) In some examples, multiple images of an IVUS pullback or "run" may be analyzed in box 407. The output of this performed analysis, as noted in box 409, may include lumen contours (e.g., including longitudinal cross sections or "long views"), vessel contours (e.g., including longitudinal cross sections or "long views"), representations of calcification length (e.g., visualizations or images, numerical visualizations, graphical visualizations, etc.), depictions / displays of reference frames (e.g., minimum lumen area or "MLA," minimum stent area or "MSA," etc.), representations of side branch location (e.g., visualizations or images, numerical visualizations, graphical visualizations, etc.), representations of the distance between two frames of interest (e.g., visualizations or images, numerical visualizations, graphical visualizations, etc.), representations of stent extension (e.g., visualizations or images, numerical visualizations, graphical visualizations, etc.), combinations thereof, etc.This may also include analyzing the images using deep neural networks (such as, for example, U-Net deep neural networks) and / or machine learning and / or artificial intelligence.

[0049] 5 is a flowchart depicting an exemplary process by which images (e.g., IVUS images generated via an IVUS pullback procedure, cross-sectional images, etc.) may be processed / segmented. For example, an exemplary cross-sectional image or group / collection of images (e.g., in box 501) may undergo image classification (e.g., in box 503), for example, to identify a lesion type (e.g., in box 505). In some examples, the output may be displayed on a display unit in an appropriate format (e.g., with words or symbols, as an actual or schematic image, graphically, numerically, etc.). In some examples, an image (e.g., in box 501) may undergo calcification detection (e.g., in box 507) to identify calcium / calcification angle or arc coverage (e.g., in box 509).

[0050] In some examples, an image (e.g., in box 501) may undergo image segmentation (e.g., in box 511). This may include boundary extraction (e.g., in box 513) to identify the lumen boundary, identify the lumen dimensions, identify the medial boundary, identify the medial dimensions, etc. (e.g., in box 515). An image 517 of a blood vessel may undergo image segmentation. This may include analyzing the image using a deep neural network (e.g., a U-Net deep neural network and / or other network trained to identify the lumen boundary, the medial boundary, or both, etc.) and / or machine learning and / or artificial intelligence. This may result in a visualization 519 in which the lumen boundary 521 and the medial boundary 523 are identified.

[0051] Interpreting calcium-related indicators / characteristics associated with intravascular calcification may require extensive experience by a skilled clinician. There is a continuing need for user-friendly displays of various calcium-related indicators / characteristics that allow clinicians of various skill levels to easily evaluate patients before, during, and / or after intervention. Disclosed herein are imaging devices and / or systems and methods for evaluating blood vessels. Some of these devices / methods may be used to analyze vascular calcification, for example, to help guide treatment. This may include software and / or processing algorithms utilizing artificial intelligence, machine learning, neural networks, and / or the like, as disclosed herein, to analyze vascular calcification.

[0052] 6 illustrates a display 600 (e.g., display 600 refers to a visual component / data component that may be displayed on a hardware component such as a display / display unit). Display 600 may include one or more cross-sectional images of a blood vessel, such as images 620a, 620b, 620c, 620d, and 620e. In this example, cross-sectional images 620a, 620b, 620c, 620d, and 620e are IVUS images of the blood vessel. It should be understood that other displays utilizing different images, such as OCT images, are contemplated. Cross-sectional images 620a, 620b, 620c, 620d, and 620e may be user-selected, or a processor (e.g., processor 106) may automatically select an image of a desired location / example location (e.g., a location where the lumen area is smallest, a reference point adjacent to the smallest lumen area, etc.). In some examples, cross-sectional images 620a, 620b, 620c, 620d, 620e (e.g., data used to generate images 620a, 620b, 620c, 620d, 620e) may be processed (e.g., using processor 106) such that additional features may be marked thereon. For example, a representation of lumen surface 622 and / or a representation of vessel surface 624 may be marked on images 620a, 620b, 620c, 620d, 620e.

[0053] The display 600 may also include a calcium map 626. The calcium map 626 may be shown as a longitudinal representation of a blood vessel, shown in a flattened or plan view. In other words, the longitudinal representation may be similar to taking a generally cylindrical or tubular structure (e.g., a blood vessel) and making a longitudinal cut in the tubular structure so that it can be laid flat. In the calcium map, the horizontal axis may represent the pullback direction of the catheter, and the vertical axis may represent the rotation angle of the catheter (e.g., the scan line). The calcium map 626 may include one or more fiducial marks / fiducial indicators, such as fiducial marks 628a, 628b, 628c, 628d, and 628e. In some examples, fiducial marks 628a, 628b, 628c, 628d, and 628e may be user-operable (e.g., using a scrubber or other user-operable feature that allows fiducial marks 628a, 628b, 628c, 628d, and 628e to be moved left or right). For example, in FIG. 6 , fiducial mark 628d is shown with a dashed line, indicating that this fiducial mark has been selected by the user. In this example, image 620e is shown with a dashed border, indicating that cross-sectional image 620e corresponds to the selected fiducial mark 628d. The selected fiducial mark 628d may be shifted by the user (e.g., by moving a scrubber that appears on display 600 when an input device is placed adjacent to fiducial mark 628d). As fiducial mark 628d is shifted, the corresponding image 620e may be updated to show a new / updated image corresponding to the new position along calcium map 626 to which fiducial mark 628d has been moved. It should be appreciated that any of the fiducial marks 628a, 628b, 628c, 628d, 628e can be similarly manipulated to allow a user to view an updated cross-sectional image at a desired location.

[0054] The display 600 may also include a region / portion 630 depicting the calcium arc angle. In this example, the extent to which calcium extends around the blood vessel is depicted. Here, it can be seen that in some parts of the blood vessel, the calcium extends around the blood vessel only a relatively short distance, while in other parts of the blood vessel, the calcium extends around the blood vessel essentially the entire circumference.

[0055] 7 illustrates a display 700 (e.g., display 700 refers to a visual component / data component that may be displayed on a hardware component, such as a display / display unit) that may be similar in form and function to other displays disclosed herein. Display 700 may include one or more cross-sectional images of a blood vessel, such as images 720a, 720b, 720c, 720d. In some examples, cross-sectional images 720a, 720b, 720c, 720d (e.g., data used to generate images 720a, 720b, 720c, 720d) may be processed (e.g., using processor 106) such that additional features may be marked thereon. For example, a representation of the lumen surface and / or a representation of the blood vessel surface may be marked on images 720a, 720b, 720c, 720d. Images 720a, 720b, 720c, 720d may also be marked to indicate correspondence to reference points (e.g., distal reference points, proximal reference points, etc.), positions corresponding to where the luminal area is smallest (e.g., smallest luminal area), positions corresponding to where the calcium angle / calcium arc is largest, and / or other desired positions.

[0056] Display 700 may also include a calcium map 726. Calcium map 726 may include one or more fiducial marks / fiducial indicators, such as fiducial marks 728b, 728c, 728d. As described with reference to FIG. 6, fiducial marks 728b, 728c, 728d may be selectable and / or manipulable by a user to customize display 700 to include a desired view.

[0057] The calcium map 726 may take the form of, or may otherwise resemble, a topographic map with marks / indications representing the distance of the detected calcium / calcification from the luminal surface and / or marks / indications representing the distance of the detected calcium / calcification from the center of the catheter. In some examples, the distance of the detected calcium / calcification from the luminal surface may be displayed using a color-coding system (different colors or grayscales correspond to different depths). A visual scale may also be displayed to assist the user in determining the magnitude of the depth. In some examples, the distance of the detected calcium / calcification from the center of the catheter may use dashed contour lines. For example, contour lines 732a, 732b, and 732c are shown in FIG. 7. Again, a visual scale may also be displayed to assist the user in determining the magnitude of the depth. Other features may also be shown in the calcium map 726. For example, the calcium map may include marks, colors, grayscales, etc. corresponding to the roughness / smoothness of the calcium surface.

[0058] The display 700 may also include a region / portion 730 depicting the calcium arc angle. In this example, the extent to which calcium extends around the blood vessel is depicted. Here, it can be seen that in some parts of the blood vessel, the calcium extends around the blood vessel only a relatively short distance, while in other parts of the blood vessel, the calcium extends around the blood vessel essentially the entire circumference.

[0059] It can be appreciated that the depth measurements depicted on calcium map 726 may be relative to the center of the imaging catheter placed within the blood vessel. Such a configuration / arrangement may be useful to assist a clinician in identifying calcium / calcification in the blood vessel. In some of these and other examples, calcium map 726 may be able to use and depict calcium depth relative to the center of the guidewire placed within the blood vessel. If so, calcium map 726 and / or other components of display 700 may be updated. In some examples, switching display 700 between the "catheter center" and the "guidewire center" may involve the user selecting the desired view, toggling a switch, and / or using another appropriate user interface.

[0060] 8 illustrates a display 800 (e.g., display 800 refers to a visual component / data component that may be displayed on a hardware component such as a display / display unit) that may be similar in form and function to other displays disclosed herein. Display 800 may include one or more cross-sectional images of a blood vessel, such as images 820a, 820b, 820c. In some examples, cross-sectional images 820a, 820b, 820c (e.g., data used to generate images 820a, 820b, 820c) may be processed (e.g., using processor 106) such that additional features may be marked thereon. For example, a representation of the lumen surface and / or a representation of the blood vessel surface may be marked on images 820a, 820b, 820c. Images 820a, 820b, 820c may also be marked to indicate correspondence to reference points (e.g., distal reference points, proximal reference points, etc.), positions corresponding to where the luminal area is smallest (e.g., smallest luminal area), positions corresponding to where the calcium angle / calcium arc is largest, and / or other desired positions.

[0061] Display 800 may also include a calcium map 826. Calcium map 826 may include one or more fiducial marks / fiducial indicators, such as fiducial marks 828b, 828c. As described with reference to FIG. 6, fiducial marks 828b, 828c may be selectable and / or manipulable by a user to customize display 800 to include a desired view.

[0062] The calcium map 826 may take the form of, or may otherwise resemble, a topographic map having marks / indications of the calcium / calcifications 832 representing the distance of the detected calcium / calcifications from the luminal surface. In some examples, the distance of the detected calcium / calcifications from the luminal surface may be displayed using a color-coding or grayscale system (different colors / grayscales correspond to different depths). A visual scale may also be displayed to assist the user in determining the magnitude of the depth.

[0063] It can be appreciated that the depth measurements depicted on calcium map 826 may be relative to the center of the imaging catheter placed within the blood vessel. Such a configuration / arrangement may be useful to assist a clinician in identifying calcium / calcification in the blood vessel. In some of these and other examples, calcium map 826 may be able to use and depict calcium depth relative to the center of the guidewire placed within the blood vessel. If so, calcium map 826 and / or other components of display 800 may be updated. In some examples, switching display 800 between "catheter center" and "guidewire center" may involve the user selecting a desired view, toggling a switch, and / or using another appropriate user interface.

[0064] 9 illustrates a display 900 (e.g., display 900 refers to a visual component / data component that may be displayed on a hardware component such as a display / display unit) that may be similar in form and function to other displays disclosed herein. Display 900 may include one or more cross-sectional images of a blood vessel, such as images 920a, 920b, 920c. In some examples, cross-sectional images 920a, 920b, 920c (e.g., data used to generate images 920a, 920b, 920c) may be processed (e.g., using processor 106) such that additional features may be marked thereon. For example, a representation of the lumen surface and / or a representation of the blood vessel surface may be marked on images 920a, 920b, 920c. The images 920a, 920b, 920c may also be marked to indicate correspondence to reference points (e.g., distal reference points, proximal reference points, etc.), locations corresponding to where the lumen area is smallest (e.g., smallest lumen area), locations corresponding to where the calcium angle / arc is largest, and / or other desired locations. Additionally or alternatively, the cross-sectional images 920a, 920b, 920c may include one or more indicators of device reach, such as indicators 934a, 934b, which may correspond to the predicted rotational atherectomy depth. For example, rotational atherectomy devices are available in a variety of different sizes (e.g., different sized tips). By overlaying indicators 934a, 934b corresponding to different sized rotational atherectomy tips, a clinician may be able to ascertain the extent to which vascular stenosis may be affected by different sized rotational atherectomy tips.

[0065] It can be appreciated that indicators 934a, 934b depicted on images 920a, 920b, 920c may be relative to the center of the imaging catheter positioned within the blood vessel. Such a configuration / arrangement may be useful to assist a clinician in identifying a treatment course. In some of these and other examples, images 920a, 920b, 920c may use and depict indicators 934a, 934b relative to the center of the guidewire positioned within the blood vessel. In that case, images 920a, 920b, 920c and / or other components of display 900 may be updated. In some examples, switching display 900 between the “catheter center” and “guidewire center” may involve the user selecting a desired view, toggling a switch, and / or using another appropriate user interface.

[0066] Display 900 may also include a calcium map 926. Calcium map 926 may include one or more fiducial marks / fiducial indicators, such as fiducial marks 928b, 928c. As described with reference to FIG. 6, fiducial marks 928b, 928c may be selectable and / or manipulable by a user to customize display 900 to include a desired view.

[0067] The calcium map 926 may take the form of, or may otherwise resemble, a topographic map with marks / indications representing the distance of the detected calcium / calcification from the luminal surface and / or marks / indications representing the distance of the detected calcium / calcification from the center of the catheter. In some examples, the distance of the detected calcium / calcification from the luminal surface may be displayed using a color-coding system (different colors or grayscales correspond to different depths). A visual scale may also be displayed to assist the user in determining the magnitude of the depth. In some examples, the distance of the detected calcium / calcification from the center of the catheter may use dashed contour lines. For example, contour lines 932a, 932b are shown in FIG. 9 . Again, a visual scale may also be displayed to assist the user in determining the magnitude of the depth. In some examples, the calcium map 926 may also include indicators corresponding to different sizes of rotational atherectomy tips (e.g., similar to those in images 920a, 920b, 920c, but modified to fit the longitudinal view used for the calcium map 926).

[0068] The display 900 may also include a region / portion 930 depicting the calcium arc angle. In this example, the extent to which calcium extends around the blood vessel is depicted. Here, it can be seen that in some parts of the blood vessel, the calcium extends around the blood vessel only a relatively short distance, while in other parts of the blood vessel, the calcium extends around the blood vessel essentially the entire circumference.

[0069] 10 illustrates a display 1000 (e.g., display 1000 refers to a visual component / data component that may be displayed on a hardware component such as a display / display unit) that may be similar in form and function to other displays disclosed herein. Display 1000 may include one or more cross-sectional images of a blood vessel, such as images 1020a, 1020b, 1020c. In some examples, cross-sectional images 1020a, 1020b, 1020c (e.g., data used to generate images 1020a, 1020b, 1020c) may be processed (e.g., using processor 106) such that additional features may be marked thereon. For example, a representation of the lumen surface and / or a representation of the blood vessel surface may be marked on images 1020a, 1020b, 1020c. The images 1020a, 1020b, 1020c may also be marked to indicate correspondence to reference points (e.g., distal reference points, proximal reference points, etc.), locations corresponding to where the lumen area is smallest (e.g., smallest lumen area), locations corresponding to where the calcium angle / arc is largest, and / or other desired locations. Additionally or alternatively, the cross-sectional images 1020a, 1020b, 1020c may include one or more indicators, such as indicators 1034a, 1034b, corresponding to the predicted rotational atherectomy depth. For example, rotational atherectomy devices are available in a variety of different sizes (e.g., different sized tips). By overlaying indicators 1034a, 1034b corresponding to different sized rotational atherectomy tips, a clinician may be able to ascertain the extent to which vascular stenosis may be affected by different sized rotational atherectomy tips.

[0070] It can be appreciated that indicators 934a, 934b depicted on images 920a, 920b, 920c shown in Figure 9 may be relative to the center of the imaging catheter positioned within the blood vessel. In Figure 10, indicators 1034a, 1034b are shown relative to the center of the guidewire positioned within the blood vessel. In some examples, switching of display 1000 between "catheter center" (e.g., as in Figure 9) and "guidewire center" may involve the user selecting a desired view, toggling a switch, and / or using another suitable user interface.

[0071] The display 1000 may also include a calcium map 1026. The calcium map 1026 may include one or more fiducial marks / fiducial indicators, such as fiducial marks 1028b, 1028c. As described with reference to FIG. 6, the fiducial marks 1028b, 1028c may be selectable and / or manipulable by a user to customize the display 1000 to include a desired view.

[0072] The calcium map 1026 may take the form of, or may otherwise resemble, a topographic map with marks / indications representing the distance of the detected calcium / calcification from the luminal surface and / or marks / indications representing the distance of the detected calcium / calcification from the center of the catheter. In some examples, the distance of the detected calcium / calcification from the luminal surface may be displayed using a color-coding system (different colors or grayscales correspond to different depths). A visual scale may also be displayed to assist the user in determining the magnitude of the depth. In some examples, the distance of the detected calcium / calcification from the center of the catheter may use dashed contour lines. For example, contour lines 1032a, 1032b are shown in FIG. 10. Again, a visual scale may also be displayed to assist the user in determining the magnitude of the depth. In some examples, calcium map 1026 may also include indicators corresponding to different sized rotational atherectomy tips (e.g., similar to those in images 1020a, 1020b, 1020c, but modified to fit the longitudinal view used for calcium map 1026).

[0073] The display 1000 may also include a region / portion 1030 depicting the calcium arc angle. In this example, the extent to which calcium extends around the blood vessel is depicted. Here, it can be seen that in some parts of the blood vessel, the calcium extends around the blood vessel only a relatively short distance, while in other parts of the blood vessel, the calcium extends around the blood vessel essentially the entire circumference.

[0074] FIG. 11 illustrates a display 1100 (e.g., display 1100 refers to a visual component / data component that may be displayed on a hardware component such as a display / display unit) that may be similar in form and function to other displays disclosed herein. Display 1100 may include three panels 1136a, 1136b, and 1136c. Each of the panels may represent a different period of an intervention. For example, panel 1136a may include a cross-sectional image of a blood vessel, a longitudinal blood vessel profile 1138a with calcium marks / calcium indications, and a calcium map 1126a for a period before the intervention. Panel 1136b may include a cross-sectional image of a blood vessel, a longitudinal blood vessel profile 1138b with calcium marks / calcium indications, and a calcium map 1126b for a period after a blood vessel preparation procedure. Panel 1136c may include a cross-sectional image of the vessel, a longitudinal vessel profile 1138c with calcium marks / calcium indication, and a calcium map 1126c over a period of time after treatment.

[0075] Calcium maps 1126a, 1126b, 1126c can include calcium segments 1140a, 1140b, 1140c. Changes in calcium segments 1140a, 1140b, 1140c can indicate changes over the course of treatment. For example, calcium segment 1140a in panel 1136a can extend completely circumferentially around a blood vessel prior to treatment. The blood vessel can be prepared, for example, by treating with an interventional device such as an angioplasty balloon, cutting balloon, and / or the like. Calcium segment 1140b can be seen to have resolved in panel 1136b after the preparation process. After treatment, calcium segment 1140c can be seen to have further resolved and separated in panel 1136c.

[0076] FIG. 12 illustrates a display 1200 (e.g., display 1200 refers to a visual component / data component that may be displayed on a hardware component such as a display / display unit) that may be similar in form and function to other displays disclosed herein. The display may include a first longitudinal view 1238a and a second longitudinal view 1238b. The first longitudinal view 1238a may represent a blood vessel before treatment. The blood vessel wall may include color / grayscale coloring corresponding to calcium arcs / calcium angles. In this example, the brightly colored spots may correspond to where the calcium arcs / calcium angles approach 360 degrees. The second longitudinal view 1238b may represent a blood vessel after treatment (e.g., after a stent is deployed within the blood vessel). The blood vessel wall may include color / grayscale coloring corresponding to calcium arcs / calcium angles. In this example, the previously seen bright spots from the first longitudinal view 1238a are less bright, indicating that the calcium has been partially decomposed and is less circumferentially around the blood vessel.

[0077] 13-14 illustrate a display 1300 (e.g., display 1300 refers to a visual component / data component that may be displayed on a hardware component such as a display / display unit) that may be similar in form and function to other displays disclosed herein. The display may include an image or video representation of a “virtual fly-through” of a blood vessel. For example, display 1300 may show a blood vessel 1340 and a treatment catheter 1342, which includes a treatment device 1344 coupled to the treatment catheter 1342. In some examples, the display may be configured as a video depicting the catheter 1342 as if it were moving within the blood vessel. In FIG. 13, the view is looking distally, while in FIG. 14, the view is flipped. In some examples, the virtual fly-through depiction may include a view showing a predicted thrombus being removed using the catheter 1342. In other words, the virtual fly-through can predict the outcome of treating the blood vessel with the catheter 1342. Image(s) / video can be obtained via volume rendering of the three-dimensional luminal surface.

[0078] For example, some exemplary IVUS imaging systems that may be used with the methods disclosed herein include, but are not limited to, those disclosed in, for example, U.S. Patent Nos. 7,246,959, 7,306,561, and 6,945,938, as well as U.S. Patent Application Publication Nos. 2006 / 0100522, 2006 / 0106320, 2006 / 0173350, 2006 / 0253028, 2007 / 0016054, and 2007 / 0038111, all of which are incorporated herein by reference.

[0079] U.S. Patent Application Publication No. 2015 / 0073279 is incorporated herein by reference. US Provisional Patent Application No. 62 / 906,546 is incorporated herein by reference. WO 2021 / 062006 is incorporated herein by reference.

[0080] It should be understood that this disclosure is, in many respects, merely illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of steps, without exceeding the scope of the disclosure. This may include, to the extent appropriate, the use of any of the features of one illustrative embodiment in other embodiments. The scope of the invention is, of course, defined in the language in which the appended claims are set forth.

Claims

1. 1. An intravascular imaging system comprising: a catheter including an imaging device; a processor coupled to the catheter and configured to process image data received from the imaging device; the processor is configured to generate a calcium map; the calcium map includes an indicator of calcium depth to the vessel luminal surface, an indicator of calcium distance to the center of the catheter, or both; the calcium map includes a longitudinal cross-sectional view having a topographic representation of calcium depth to the vessel lumen surface, a topographic representation of calcium distance to the center of the catheter, or both; a display unit coupled to the processor and configured to display a display including the calcium map.

2. The intravascular imaging system of claim 1 , wherein the calcium map comprises a grayscale depiction of calcium depth to the vessel luminal surface.

3. The intravascular imaging system of claim 1 , wherein the calcium map comprises a grayscale depiction of calcium distance to the center of the catheter.

4. The intravascular imaging system of claim 1 , wherein the display includes a cross-sectional representation of a blood vessel.

5. The intravascular imaging system of claim 4 , wherein the cross-sectional representation of the blood vessel includes a representation of one or more therapeutic devices superimposed on the cross-sectional representation.

6. The intravascular imaging system of claim 5 , wherein the representation of the one or more treatment devices includes one or more depictions of the size of a rotational atherectomy device.

7. The intravascular imaging system of claim 1 , wherein the display includes multiple panels corresponding to different periods during an intervention.

8. The intravascular imaging system of claim 7 , wherein the plurality of panels includes a pre-treatment panel, a pre-lesion treatment panel, and a post-treatment panel.

9. The intravascular imaging system of claim 1 , wherein the imaging device comprises an intravascular ultrasound device.

10. The intravascular imaging system of claim 1 , wherein the imaging device comprises an optical coherence tomography device.

11. 1. An intravascular imaging system comprising: a catheter system including an intravascular imaging device; a processor coupled to the catheter system and configured to process image data received from the intravascular imaging device; the processor is configured to generate a calcium map that graphically depicts an indicator of calcium depth to a vessel lumen surface, an indicator of calcium distance to a center of the catheter system, or both; the calcium map includes a longitudinal cross-sectional view having a topographic representation of calcium depth to the vessel lumen surface, a topographic representation of calcium distance to the center of the catheter system, or both; a display unit coupled to the processor and configured to display a display including the calcium map.

Images