Intraluminal imaging system, intravascular imaging system, and computer program

Abstract

To provide intraluminal ultrasound navigation guidance capable of accurate measurement and labeling, and related devices, systems, and methods.SOLUTION: Disclosed is an intraluminal ultrasound imaging system, comprising a processor circuit in communication with an intraluminal ultrasound imaging catheter, and configured to receive an intraluminal ultrasound image from the imaging catheter within a body lumen of a patient, the body lumen comprising a plurality of segments. The processor circuit is configured to identify a segment of the plurality of segments where the imaging catheter was located when the image was obtained, and output to a display a stylized figure of the body lumen including the plurality of segments, and an indicator identifying the segment in the stylized figure where the imaging catheter was located when the image was obtained.SELECTED DRAWING: Figure 5

Description

Technical Field

[0001] Cross - reference to Related Applications

[0001] This application claims the benefit and priority of U.S. Provisional Patent Application No. 62 / 750,983, filed Oct. 26, 2018, the entire disclosure of which is incorporated herein by reference.

[0002]

[0002] The subject matter described herein relates to systems for medical imaging. In particular, the present disclosure describes aspects related to the acquisition, display, identification, and annotation of intravascular ultrasound or IVUS images, and navigation assistance to clinicians during image acquisition. This system has particular but not exclusive utility for the diagnosis and treatment of vascular disease.

Background Art

[0003]

[0003] Various types of intravascular imaging systems are used to diagnose and treat diseases. For example, intravascular ultrasound (IVUS) imaging is used as a diagnostic tool to visualize blood vessels within a patient's body. This is useful for assessing diseased or compressed blood vessels, such as arteries or veins, within the human body, determining the need for treatment, optimizing treatment, and / or evaluating the effectiveness of treatment.

[0004]

[0004] Different diseases or medical procedures result in physical characteristics that include different dimensions, structures, densities, water content, and ease of access to imaging sensors. For example, deep vein thrombosis (DVT) generates blood cell clots, while post-thrombotic syndrome (PTS) results in web formation or other residual structural effects in the vessel that have a composition similar to the vessel wall itself, making them difficult to distinguish from the vessel wall. A stent is a high-density (e.g., metallic) object located inside a vessel or lumen to hold the vessel or lumen open to a specific diameter. In some examples, intraluminal imaging is performed using an IVUS device that includes one or more ultrasound transducers. The IVUS device is passed into the vessel and guided to the area to be imaged. The transducers emit ultrasound energy and receive ultrasound echoes reflected from the vessel. The ultrasound echoes are processed to produce an image of the vessel of interest. The image of the vessel of interest includes one or more lesions or occlusions within the vessel. Stents are placed within the blood vessel to address these occlusions, and intraluminal imaging is performed to visualize the placement of the stent within the blood vessel. Other types of procedures include thrombectomy, ablation, vascular reconstruction, and drug therapy.

[0005]

[0005] When using IVUS to treat peripheral vascular (PV) disease, it is common for the vascular surgeon to handle the IVUS catheter while instructing staff members who have not been eradicated to operate the IVUS console. During the procedure (e.g., the retraction procedure), the vascular surgeon typically instructs the operator who has not been eradicated to bookmark important anatomical markers for post-IVUS retraction analysis. [Overview of the Initiative]

[0006]

[0006] Post-IVUS pullback analysis is a tedious task for non-sterilized (and typically non-IVUS specialist) staff to accurately label and measure all segments and critical frames within those segments. However, accurate measurement and labeling are crucial for testing, reimbursement, record keeping, and optimal treatment planning.

[0007]

[0007] The information contained in this background art section of this specification, including any references and any descriptions or discussions thereof, that are cited herein is provided for technical reference purposes only and is not intended to be subject matter that limits the scope of this disclosure.

[0008]

[0008] A system is disclosed for calculating, displaying, and marking the position of an intravascular imaging probe during IVUS retraction or other intraluminal procedures that require precise knowledge information of the position of each IVUS frame within a vascular structure. In particular, according to at least one embodiment of the present disclosure, a system is provided for identifying, displaying, and recording segments of a patient's vascular structure in relation to a live IVUS image captured within the vascular structure. This is particularly useful during manually controlled intravascular procedures where detailed knowledge information of the imaging probe's position is desired. The system helps to facilitate understanding of the correlation between IVUS frames and anatomical structures and provides positional navigation information by visually highlighting segments in arteries or vessels that require attention. The system may be referred to as an IVUS retraction virtual venography system. The IVUS retraction virtual venography systems disclosed herein have specific but not exclusive utility for intraluminal ultrasound imaging procedures.

[0009]

[0009] The IVUS retraction virtual venography system includes an IVUS imaging system comprising a processor circuit configured for communication with an intraluminal ultrasound imaging catheter, wherein the processor circuit is configured to receive intraluminal ultrasound images acquired by the intraluminal ultrasound imaging catheter while the intraluminal ultrasound imaging catheter is positioned in the patient's body lumen, and to output a screen display to a display that communicates with the processor circuit, which includes a standard diagram of the body lumen including multiple segments, an indicator that identifies the segment in the standard diagram where the intraluminal ultrasound imaging catheter was positioned when the intraluminal ultrasound image was acquired, and an indicator that identifies the segment in the standard diagram where the intraluminal ultrasound imaging catheter was positioned when the intraluminal ultrasound image was acquired.

[0010]

[0010] Embodiments may include one or more of the following features: In the system, the screen display further includes markers indicating the proximal and distal boundaries of one or more segments in a standardized diagram. In the system, the screen display further includes markers indicating a position of interest in the standardized diagram. In the system, the screen display further includes one or more labels identifying one or more segments in the standardized diagram. In the system, the screen display further includes a position indicator indicating the position within the segment in the standardized diagram where the intraluminal ultrasound imaging catheter was located when the intraluminal image was acquired. In the system, the processor circuit is configured to sequentially identify a plurality of segments in the standardized diagram as the intraluminal ultrasound imaging catheter moves through the plurality of segments. In the system, the processor circuit is configured to automatically label the sequentially identified plurality of segments in the standardized diagram. In the system, the processor circuit is configured to automatically annotate the sequentially identified plurality of segments in the standardized diagram with statistically representative reference values ​​associated with the corresponding segments. In the above system, the processor circuit is configured to automatically annotate a series of sequentially identified segments in a standardized diagram based on automatically measured or calculated values ​​associated with the corresponding segments. In the above system, the processor circuit is configured to color-code a series of sequentially identified segments based on the ratio of automatically measured or calculated values ​​to statistically representative reference values. In the above system, the processor circuit is configured to receive user input indicating the location of the intraluminal ultrasound imaging catheter when the intraluminal ultrasound image was acquired. In the above system, the processor circuit is configured to automatically determine the location of the intraluminal ultrasound imaging catheter when the intraluminal ultrasound image was acquired, based on the intraluminal ultrasound image.In the system described above, the screen display further includes at least one of the following: a longitudinal display of the body lumen, a velocity indicator related to the movement of the intraluminal ultrasound imaging catheter, or instructions for the user. The system further includes the intraluminal ultrasound imaging catheter. Embodiments of the technology described include hardware, methods or processes, or computer software in a computer-accessible medium.

[0011]

[0011] One general embodiment includes an intraluminal ultrasound imaging method comprising: a step of receiving an intraluminal ultrasound image acquired by an intraluminal ultrasound imaging catheter while the intraluminal ultrasound imaging catheter is positioned in a patient's body lumen, wherein the body lumen includes a plurality of segments; a step of using the processor circuit to identify the segment in the plurality of segments where the intraluminal ultrasound imaging catheter was positioned when the intraluminal ultrasound image was acquired; and a step of outputting a screen display to a display communicating with the processor circuit, which includes a typical diagram of the body lumen including the plurality of segments and an indicator identifying the segment in the typical diagram where the intraluminal ultrasound imaging catheter was positioned when the intraluminal ultrasound image was acquired. Other embodiments of this embodiment include corresponding computer systems, devices, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0012]

[0012] One general embodiment includes an intravascular ultrasound imaging system for use in peripheral vascular structures, the system being an intravascular ultrasound imaging catheter configured to acquire intravascular ultrasound images while the intravascular ultrasound imaging catheter is positioned within a patient's peripheral blood vessel, the peripheral blood vessel including the intravascular ultrasound imaging catheter, which includes a plurality of segments, and a processor circuit configured for communication with the intravascular ultrasound imaging catheter, the processor circuit being configured to receive intravascular ultrasound images acquired by the intravascular ultrasound imaging catheter, identify the segment of the plurality of segments in which the intravascular ultrasound imaging catheter was positioned when the intravascular ultrasound image was acquired, and output a screen display to a display communicating with the processor circuit, which includes a typical diagram of the peripheral blood vessel including the plurality of segments and an indicator identifying the segment in the typical diagram in which the intravascular ultrasound imaging catheter was positioned when the intravascular ultrasound image was acquired. Other embodiments of this embodiment include corresponding computer systems, devices, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the Method.

[0013]

[0013] This summary is provided in a simplified form to present a selection of concepts that will be described in more detail below in embodiments for carrying out the invention. This summary is not intended to determine any important or essential features of the subject matter described in the claims, nor is it intended to limit the scope of the subject matter described in the claims. A more extensive description of the features, details, usefulness and advantages of the IVUS retraction virtual venography system as defined in the claims is provided in the following descriptions of various embodiments of the disclosure and is shown in the accompanying drawings.

[0014]

[0014] Exemplary embodiments of the present disclosure will be described with reference to the accompanying drawings. [Brief explanation of the drawing]

[0015] [Figure 1]

[0015] This is a schematic diagram of an intraluminal imaging system according to an aspect of the present disclosure. [Figure 2]

[0016] This diagram shows the blood vessels (e.g., arteries and veins) inside the human body. [Figure 3]

[0017] This is a diagram showing blood vessels containing blood clots. [Figure 4]

[0018] This diagram shows a blood vessel containing a blood clot and a stent that has been expanded within the vessel to restore blood flow. [Figure 5]

[0019] This figure shows an exemplary cartoon roadmap or virtual venography screen display at the start of the retraction process of an imaging catheter in the inferior vena cava or abdominal vena cava, according to at least one embodiment of the present disclosure. [Figure 6]

[0020] This figure shows an exemplary cartoon roadmap or virtual venography screen display during the withdrawal process of an imaging catheter in the inferior vena cava, according to at least one embodiment of the present disclosure. [Figure 7]

[0021] This figure shows a screen display of an exemplary virtual venography after the transducer array at the end of the catheter has been moved into the left common iliac vein, according to at least one embodiment of the present disclosure. [Figure 8]

[0022] This figure shows an exemplary cartoon roadmap or virtual venography screen display after the transducer array at the end of the catheter has been moved into the left external iliac vein, according to at least one embodiment of the present disclosure. [Figure 9]

[0023] This figure shows a screen display of an exemplary virtual venography after the transducer array at the end of the catheter has been moved into the left common femoral vein, according to at least one embodiment of the present disclosure. [Figure 10]

[0024] FIG. is a screenshot diagram of an exemplary IVUS system incorporating a virtual venogram according to at least one embodiment of the present disclosure. [Figure 11A]

[0025] FIG. is a diagram showing a screen display of a virtual venogram at the start of the pullback process according to at least one embodiment of the present disclosure. [Figure 11B]

[0026] FIG. is a diagram showing a screen display of a live view during the pullback process according to at least one embodiment of the present disclosure. [Figure 12]

[0027] FIG. is a diagram showing a screen display during pullback, for example during recording of IVUS data, according to at least one embodiment of the present disclosure. [Figure 13]

[0028] FIG. is a diagram showing a screen display during review of an IVUS image acquired during pullback. [Figure 14]

[0029] FIG. is a diagram showing a screen display for review of IVUS image data according to at least one embodiment of the present disclosure. [Figure 15]

[0030] FIG. is a diagram showing a screen display for review of IVUS image data according to at least one embodiment of the present disclosure. [Figure 16]

[0031] FIG. is a diagram showing a screen display for review of IVUS image data according to at least one embodiment of the present disclosure. [Figure 17]

[0032] FIG. is a diagram showing a screen display during pullback, for example during recording of IVUS data, according to at least one embodiment of the present disclosure. [Figure 18]

[0033] FIG. is a diagram showing an exemplary screen display during the latter stage of IVUS pullback according to at least one embodiment of the present disclosure. [Figure 19]

[0034] This figure shows an exemplary screen display at or near the end of IVUS retraction according to at least one embodiment of the present disclosure. [Figure 20]

[0035] This figure is a screenshot of the IVUS access point selection screen according to at least one embodiment of the present disclosure. [Figure 21]

[0036] This is a screenshot of a user guidance screen display according to at least one embodiment of the present disclosure. [Figure 22]

[0037] This is a screenshot of the pullback navigation and marking display according to at least one embodiment of the present disclosure. [Figure 23]

[0038] This is a screenshot of the pullback navigation and marking display according to at least one embodiment of the present disclosure. [Figure 24]

[0039] This is a flowchart illustrating an exemplary intraluminal direction guidance method according to an aspect of the present disclosure. [Figure 25]

[0040] This is a schematic diagram of a processor circuit according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0016]

[0041] This disclosure generally relates to medical imaging, encompassing imaging related to patient body lumens using intraluminal imaging devices. For example, this disclosure describes systems, devices, and methods for determining and marking the position of an intravascular imaging probe within a patient's vascular structure. According to at least one embodiment of this disclosure, a system is provided for identifying, displaying, and recording segments of a patient's vascular structure in relation to live IVUS images captured within the vascular structure. This is particularly useful during manually controlled intravascular procedures where detailed knowledge information of the imagin probe's position is desired. This system, hereafter referred to as the IVUS Retraction Virtual Venography System, provides positional navigation information by helping to facilitate understanding of the correlation between the IVUS frame and anatomical structures, and by identifying and visually highlighting segments in arteries or vessels that require attention.

[0017]

[0042] The devices, systems, and methods described herein are subject to U.S. Provisional Patent Application No. 62 / 750,983 (Agent Document Reference Number 2018PF01112-44755.2000PV01), filed on 26 October 2018, U.S. Provisional Patent Application No. 62 / 751,268 (Agent Document Reference Number 2018PF01160-44755.1997PV01), filed on 26 October 2018, U.S. Provisional Patent Application No. 62 / 751,289 (Agent Document Reference Number 2018PF01159-44755.1998PV01), and U.S. Provisional Patent Application No. 62 / 751,289, filed on 26 October 2018. This may include one or more features described in U.S. Provisional Patent Application No. 62 / 750,996 (Agent Document Reference No. 2018PF01145-44755.1999PV01), U.S. Provisional Patent Application No. 62 / 751,167 filed on 26 October 2018 (Agent Document Reference No. 2018PF01115-44755.2000PV01), and U.S. Provisional Patent Application No. 62 / 751,185 filed on 26 October 2018 (Agent Document Reference No. 2018PF01116-44755.2001PV01), which are incorporated herein by reference in the same manner as the entirety of each application is fully described herein.

[0018]

[0043] The devices, systems, and methods described herein are based on U.S. Provisional Patent Application No. 62 / 642,847 (Agent Document Reference No. 2017PF02103) filed on 14 March 2018 (and a non-provisional patent application filed on 12 March 2019 as U.S. Patent Application No. 16 / 351175 based on the said application), U.S. Provisional Patent Application No. 62 / 712,009 (Agent Document Reference No. 2017PF02296) filed on 30 July 2018, and a U.S. Provisional Patent Application filed on 30 July 2018. This specification may further include one or more features described in U.S. Provisional Patent Application No. 62 / 711,927 (Agent Document Reference No. 2017PF02101) and U.S. Provisional Patent Application No. 62 / 643,366 (Agent Document Reference No. 2017PF02365) filed on 15 March 2018 (and the non-provisional patent application filed on 15 March 2019 as U.S. Patent Application No. 16 / 354970 based on said application), which are incorporated herein by reference in the same manner as the entirety of each application is fully described herein.

[0019]

[0044] This disclosure substantially assists clinicians in orienting, navigating, and guiding intravascular imaging probes or intraluminal imaging probes within a patient's blood vessels or lumens by providing a venography-type roadmap during intraluminal medical imaging procedures. The venography-type roadmap may include typical, statistically representative human anatomical structures, along with directional indicators, automated measurement tools, step-by-step navigation or operation instructions, and a correlated vascular map showing the probe's position within the patient's anatomical structures. Implemented in a medical imaging console (e.g., an intraluminal imaging console) communicating with a medical imaging sensor (e.g., an intraluminal ultrasound sensor), the IVUS pullback virtual venography system disclosed herein offers both time savings and improved certainty of the position of captured images. This improved imaging workflow translates raw imaging data into an annotated roadmap, anatomical measurement results, and step-by-step instructions for the clinician performing a given procedure. This is done without the need for the typically routine manual interpretation of clinical images to determine the anatomical position and orientation of the clinical images. This unconventional approach improves the functionality of medical imaging consoles and sensors by enabling more efficient workflows and more useful clinical outputs. Aspects of coregistration are described, for example, in U.S. Patents 7,930,014 and 8,298,147, which are incorporated herein by reference in their entirety. Typical figures may include diagrams, schematics, drawings, or graphics that are stored in and retrieved from memory (e.g., common to all patients or representative of all patients), or generated from data acquired from one or more IVUS images, and that differ from actual images acquired by an imaging device (e.g., X-ray or IVUS).

[0020]

[0045] The IVUS retraction virtual venography system is implemented as a set of logical branches and mathematical operations computed by a control process performed in a processor whose output is visible on a display, accepts user input from a keyboard, mouse, or touchscreen interface, and communicates with one or more medical imaging sensors (e.g., intraluminal ultrasound sensors). In this regard, the control process may perform specific calculations in response to different inputs or selections made by the user at the start of the imaging process and in response to inputs made by the user during the process. The specific structures, functions, and operations of the processor, display, sensors, and user input systems are known in the art and are described herein in detail to enable novel features or embodiments of the present disclosure.

[0021]

[0046] Various types of intraluminal imaging systems are used to diagnose and treat diseases. For example, intravascular ultrasound (IVUS) imaging is used as a diagnostic tool to visualize blood vessels within a patient's body. This helps to evaluate affected or compressed blood vessels, such as arteries or veins, within the human body to determine the need for treatment, to optimize treatment, and / or to evaluate the effectiveness of treatment (e.g., through imaging of blood vessels before and after treatment).

[0022]

[0047] In some cases, intraluminal imaging is performed using an IVUS device containing one or more ultrasound transducers. The IVUS device is inserted into the blood vessel and guided to the area to be imaged. The transducers emit ultrasound energy and receive ultrasound echoes reflected from the blood vessel. The ultrasound echoes are processed to produce an image of the blood vessel of interest. The image of the blood vessel of interest includes one or more lesions or sites of stenosis due to occlusion and / or compression within the blood vessel. A stent is positioned within the blood vessel to treat these occlusions or stenosis, and intraluminal imaging is performed to view the placement of the stent within the blood vessel. Other types of procedures include thrombectomy, ablation, vascular reconstruction, and drug therapy.

[0023]

[0048] In particular, because physicians view only cross-sectional IVUS images and reconstructed longitudinal views (image longitudinal display or ILD) on a dedicated IVUS screen without any anatomical reference points (bone markers) that they can use as a reference, understanding which artery or vascular segment a particular IVUS frame belongs to can be difficult and time-consuming. To understand the position of the IVUS probe in relation to the patient's anatomical structure, physicians view the fluoroscopic images being retracted, which are currently positioned on a separate screen. Furthermore, during peripheral vascular intervention, the anatomical reference points for segment boundaries are the confluences and branchings with other vessels that physicians and other users recognize in IVUS during retraction and in live mode, and that physicians and other users must remember. Clinicians also require less experienced clinician assistants to focus on areas of interest. The IVUS retraction virtual venography system overcomes the lack of reference points, displays the relative position of IVUS frames, and simplifies the interpretation of IVUS images. The IVUS retraction virtual venography system depicts this information in a single, simple, and standardized anatomical visualization, which aids in image interpretation after the retraction is complete and provides a visualization in the context of bookmarked frames. The IVUS retraction virtual venography system reduces the dependence of the vascular surgeon on their staff. Upon completion of the retraction, the IVUS measurement results are automatically plotted in the IVUS retraction virtual venography system in an easily interpretable manner.

[0024]

[0049] During retraction, marking confluences, healthy frames, and the most occluded frames is currently typically performed by staff who have not undergone H. pylori eradication. In a common scenario, these personnel bookmark on the IVUS screen as directed by the physician. However, often there is a time delay between the two actions, resulting in shifted bookmarked frames. In addition, labeling may not be possible during bookmarking, and therefore the bookmarks are not distinguishable in the ILD view, making the reporting task (post-case) longer and more cumbersome. The IVUS retraction virtual venography system simplifies communication between vascular surgeons and their staff by automatically and clearly labeling frames and segments. The IVUS retraction virtual venography system saves a lot of time for operators who have not undergone H. pylori eradication, makes medical records more complete, and makes it much easier to direct vascular surgeons to cases. The IVUS retraction virtual venography system automatically labels important frames of interest by capturing vascular segments containing important frames of interest (e.g., external iliac vein (EIV), EIV criteria, EIV pre-objects).

[0025]

[0050] The IVUS retraction virtual venography system includes a graphical display of the venogram, along with positional navigation assistance, vascular and arterial segmentation, highlighted segments of interest or requiring attention, highlighting of IVUS frame positions, and automatic labeling and prompting.

[0026]

[0051] These descriptions are provided for illustrative purposes only and should not be considered to limit the scope of IVUS retraction virtual venography systems. Certain features may be added, removed, or modified without departing from the spirit of the subject matter described in the claims.

[0027]

[0052] For the purpose of enhancing the understanding of the principles of this disclosure, embodiments depicted in the drawings are referenced below, and specific expressions are used to describe those embodiments. Nevertheless, it is understood that this is not intended to limit the scope of this disclosure. Any alternatives and further modifications to the devices, systems, and methods described, and any further applications of the principles of this disclosure, are well assumed and included in this disclosure as would ordinarily conceivable to those skilled in the art relating to this disclosure. In particular, it is well assumed that features, components, and / or steps described in relation to one embodiment may be combined with features, components, and / or steps described in relation to other embodiments of this disclosure. However, for the sake of brevity, many repetitive matters relating to these combinations are not described individually.

[0028]

[0053] Figure 1 is a schematic diagram of an intraluminal imaging system incorporating an IVUS retraction virtual venography system according to an aspect of the present disclosure. In some embodiments, the intraluminal imaging system 100 may be an intravascular ultrasound (IVUS) imaging system. The intraluminal imaging system 100 includes an intraluminal device 102, a patient interface module (PIM) 104, a console or processing system 106, a monitor 108, and an external imaging system 132 including vascular imaging, ultrasound, X-ray, computed tomography (CT), magnetic resonance imaging (MRI), or other imaging techniques, instruments, and methods. The intraluminal device 102 is sized, shaped, and / or otherwise structurally configured to be placed within a patient's body lumen. For example, the intraluminal device 102 is a catheter, guidewire, guidance catheter, pressure wire, and / or flow wire in various embodiments. In some situations, system 100 may be implemented with and / or without one or more of the elements shown in Figure 1. For example, system 100 may omit the external imaging system 132.

[0029]

[0054] The intraluminal imaging system 100 (or intravascular imaging system) may be any type of imaging system suitable for use in a patient's lumen or vascular structure. In some embodiments, the intraluminal imaging system 100 is an intraluminal ultrasound (IVUS) imaging system. In other embodiments, the intraluminal imaging system 100 includes a system configured for forward-looking intraluminal ultrasound (FL-IVUS) imaging, intraluminal photoacoustic (IVPA) imaging, intracardiac echocardiography (ICE), transesophageal echocardiography (TEE), and / or other appropriate imaging modalities.

[0030]

[0055] It is understood that system 100 and / or device 102 may be configured to acquire any suitable intraluminal imaging data. In some embodiments, device 102 may include imaging components of any suitable imaging modality, such as optical imaging, optical coherence tomography (OCT), etc. In some embodiments, device 102 may include any suitable non-imaging components, including pressure sensors, flow sensors, temperature sensors, optical fibers, reflectors, mirrors, prisms, ablation elements, radio frequency (RF) electrodes, conductors, or combinations thereof. Generally, device 102 may include imaging elements for acquiring intraluminal imaging data related to the lumen 120. Device 102 is sized and shaped (and / or configured) for insertion into a patient's blood vessel or lumen 120.

[0031]

[0056] System 100 is deployed in a catheterization laboratory, including a control room. Processing system 106 is located within the control room. Optionally, processing system 106 may be located elsewhere, for example, in the catheterization laboratory itself. The catheterization laboratory may include a sterilization area, and its associated control room may be sterilized or not, depending on the process performed and / or the healthcare facility. The catheterization and control rooms are used to perform any number of medical imaging procedures, such as vascular angiography, fluoroscopy, CT, IVUS, virtual tissue structure (VH), forward-looking IVUS (FL-IVUS), intraluminal photoacoustic (IVPA) imaging, fractional flow reserve (FFR) determination, coronary flow reserve (CFR) determination, optical coherence tomography (OCT), computed tomography, intracardiac echocardiography (ICE), forward-looking ICE (FLICE), intraluminal pulpography, transesophageal ultrasound, fluoroscopy, and other medical imaging modalities, or combinations thereof. In some embodiments, the device 102 is controlled from a remote location, such as a control room, and therefore the operator is not required to be very close to the patient.

[0032]

[0057] The intraluminal device 102, PIM 104, monitor 108, and external imaging system 132 are communicably coupled directly or indirectly to the processing system 106. These elements are communicably coupled to the medical processing system 106 via wired connections, e.g., standard copper or fiber optic links, and / or via wireless connections using IEEE 802.11 Wi-Fi, ultra-wideband (UWB), wireless FireWire, wireless USB, or other high-speed wireless networking standards. The processing system 106 is communicably coupled to one or more data networks, such as a TCP / IP-based local area network (LAN). In other embodiments, different protocols are used, such as synchronous optical networking (SONET). In some examples, the processing system 106 is communicably coupled to a wide area network (WAN). The processing system 106 uses network connectivity to access various resources. For example, the processing system 106 communicates with a medical digital imaging and communication (DICOM) system, a picture archiving and communication system (PACS), and / or a hospital information system via a network connection.

[0033]

[0058] At high levels, the intraluminal ultrasound imaging device 102 emits ultrasonic energy from a transducer array 124 contained in a scanner assembly 110 mounted near the distal end of the intraluminal device 102. The ultrasonic energy is reflected by tissue structures in the medium (e.g., the lumen 120) around the scanner assembly 110, and ultrasonic echo signals are received by the transducer array 124. The scanner assembly 110 generates electrical signals representing the ultrasonic echoes. The scanner assembly 110 may include one or more single ultrasonic transducers and / or a transducer array 124 in any suitable configuration, such as a planar array, a curved array, a circumferential array, or an annular array. For example, the scanner assembly 110 may in some cases be a one-dimensional array or a two-dimensional array. In some cases, the scanner assembly 110 may be a rotary ultrasonic device. The effective area of ​​the scanner assembly 110 may include one or more transducer members and / or one or more segments of ultrasonic elements (e.g., one or more rows, one or more columns, and / or one or more orientations) that can be controlled and enabled uniformly or independently. The effective area of ​​the scanner assembly 110 may be patterned or structured into a variety of basic or complex shapes. The scanner assembly 110 may be positioned in a side-looking orientation (e.g., ultrasonic energy is emitted perpendicular and / or orthogonal to the long axis of the intraluminal device 102) and / or in a forward-looking orientation (e.g., ultrasonic energy is emitted parallel and / or along the long axis). In some cases, the scanner assembly 110 is structurally positioned to emit and / or receive ultrasonic energy at an angle inclined with respect to the long axis in the proximal or distal direction. In some embodiments, the emission of ultrasonic energy can be electronically controlled by selectively triggering one or more transducer elements of the scanner assembly 110.

[0034]

[0059] The ultrasonic transducers of the scanner assembly 110 may be piezoelectric micromachined ultrasonic transducers (PMUTs), capacitive micromachined ultrasonic transducers (CMUTs), single crystals, lead zirconate titanate (PZT), PZT composite materials, other suitable transducer types, and / or combinations thereof. In one embodiment, the ultrasonic transducer array 124 may include any suitable number of individual transducer elements or acoustic elements between 1 and 1000 acoustic elements, encompassing values ​​such as 2 acoustic elements, 4 acoustic elements, 36 acoustic elements, 64 acoustic elements, 128 acoustic elements, 500 acoustic elements, 812 acoustic elements, and / or other values ​​greater than and less than the above.

[0035]

[0060] The PIM 104 transmits the received echo signal to a processing system 106 in which an ultrasound image (including flow rate information) is reconstructed and displayed on the monitor 108. The console or processing system 106 may include a processor and memory. The processing system 106 is operable to facilitate the functions of the intraluminal imaging system 100 as described herein. For example, the processor may execute computer-readable instructions stored on a non-temporary, tangible, computer-readable medium.

[0036]

[0061] The PIM 104 facilitates signal communication between the processing system 106 contained within the intratubular device 102 and the scanner assembly 110. This communication includes providing commands to an integrated circuit control chip within the intratubular device 102, selecting specific elements in a transducer array 124 used for transmission and reception, providing a transmit trigger signal to the integrated circuit control chip to activate a transmitter circuit to generate electrical pulses to excite the selected transducer array elements, and / or receiving amplified echo signals received from the selected transducer array elements via an amplifier contained within the integrated circuit control chip. In some embodiments, the PIM 104 performs preliminary processing of the echo data before relaying the data to the processing system 106. In examples of such embodiments, the PIM 104 performs amplification, filtering, and / or collection of the data. In one embodiment, the PIM 104 further supplies high-voltage and low-voltage DC power to support the operation of the intratubular device 102, including the circuitry within the scanner assembly 110.

[0037]

[0062] The processing system 106 receives echocardiogram data from the scanner assembly 110 via the PIM 104 and processes the data to reconstruct images of tissue structures in the medium around the scanner assembly 110. Generally, the device 102 can be used in any suitable anatomical structure and / or within the body lumen of a patient. The processing system 106 outputs image data so that an image of a blood vessel or lumen 120, for example, a cross-sectional IVUS image of the lumen 120, is displayed on the monitor 108. The lumen 120 represents a structure filled with or surrounded by fluid, i.e., both natural and artificial. The lumen 120 is located inside the patient's body. The lumen 120 is a blood vessel, such as an artery or vein in the patient's vascular system, encompassing cardiac vascular structures, peripheral vascular structures, neurovascular structures, renal vascular structures and / or any other suitable lumen in the body. For example, device 102 may be used to examine any number of anatomical locations and tissue types, including, but not limited to, organs encompassing the liver, heart, kidneys, gallbladder, pancreas, and lungs; tubules; intestines; nervous system structures encompassing the brain, dural sac, spinal cord, and peripheral nerves; the urinary tract; and valves in the blood vessels, chambers, or other parts of the heart, and / or other systems of the body. In addition to natural structures, device 102 may be used to examine artificial structures such as, but not limited to, heart valves, stents, shunts, filters, and other devices.

[0038]

[0063] The control unit or processing system 106 includes processing circuitry including one or more processors that communicate with memory and / or other suitable tangible computer-readable storage media. The control unit or processing system 106 is configured to perform one or more aspects of the present disclosure. In some embodiments, the processing system 106 and the monitor 108 are separate components. In other embodiments, the processing system 106 and the monitor 108 are integrated into a single component. For example, system 100 may include a touchscreen device including a housing that includes a touchscreen display and a processor. System 100 may include any suitable input device for the user to select options shown on the monitor 108, such as a touch-sensitive pad or touchscreen display, keyboard / mouse, joystick, or buttons. The processing system 106, the monitor 108, the input device, and / or a combination thereof may be referred to as the control unit of system 100. The control unit may communicate with device 102, PIM 104, processing system 106, monitor 108, the input device, and / or other components of system 100.

[0039]

[0064] In some embodiments, the intraluminal device 102 includes several features similar to those of a conventional solid-state IVUS catheter, such as the EagleEye® catheter available from Philips, and those disclosed in U.S. Patent No. 7,846,101, which is incorporated herein by reference in whole. For example, the intraluminal device 102 includes a scanner assembly 110 near the distal end of the intraluminal device 102 and a transmission line bundle 112 extending along the longitudinal body of the intraluminal device 102. The cable or transmission line bundle 112 may include multiple conductors, such as one, two, three, four, five, six, seven, or more.

[0040]

[0065] The transmission line bundle 112 terminates at a PIM connector 114 at the proximal end of the intraluminal device 102. The PIM connector 114 electrically connects the transmission line bundle 112 to the PIM 104 and physically connects the intraluminal device 102 to the PIM 104. In one embodiment, the intraluminal device 102 further includes a guidewire exit port 116. Thus, in some cases, the intraluminal device 102 is a rapidly replaceable catheter. The guidewire exit port 116 allows a guidewire 118 to be inserted toward the distal end in order to orient the intraluminal device 102 through the lumen 120.

[0041]

[0066] Monitor 108 is a display device, such as a computer monitor or another type of screen. Monitor 108 is used to display selectable prompts, instructions, and visualization results of imaging data to the user. In some embodiments, Monitor 108 is used to provide the user with a process-specific workflow for performing an intraluminal imaging process. This workflow includes performing a pre-stent planning to determine the lumen condition and stent potential, and a post-stent examination to determine the status of a stent placed in the lumen. The workflow is presented to the user as any of the displays or visualization results shown in Figures 5 to 7.

[0042]

[0067] The external imaging system 132 may be configured to acquire X-ray, radiography, vascular / venography (e.g., with contrast agents), and / or fluoroscopic images (e.g., without contrast agents) of the patient's body (including blood vessels 120). The external imaging system 132 may be configured to acquire computed tomography images of the patient's body (including blood vessels 120). The external imaging system 132 includes an external ultrasound probe configured to acquire ultrasound images of the patient's body (including blood vessels 120) while being located outside the body. In some embodiments, system 100 includes other imaging modality systems (e.g., MRI) for acquiring images of the patient's body (including blood vessels 120). The processing system 106 may use images of the patient's body in combination with intraluminal images acquired by the intraluminal device 102.

[0043]

[0068] Figure 2 shows blood vessels (e.g., arteries and veins) in the human body. For example, veins in the human body are labeled. Aspects of this disclosure may relate to peripheral vascular structures, such as veins in the torso or legs.

[0044]

[0069] Obstruction can occur in arteries or veins. Obstruction can generally refer to any blockage or other structural configuration that results in restriction of fluid flow through a lumen (e.g., artery or vein) by means of a method that is detrimental to the patient's health. For example, an obstruction narrows the lumen so that the cross-sectional area of ​​the lumen and / or the available space for fluid to flow through the lumen is reduced. When the anatomical structure is a blood vessel, the obstruction is the result of stenosis caused by compressive plaque accumulation (e.g., from external blood vessels) that includes, but is not limited to, plaque components, e.g., fibrous, fibrolipid (fibrofat), necrotic core, calcification (high-density calcium), blood, and / or thrombi of different stages (acute, subacute, chronic, etc.). In some cases, obstruction may be called thrombosis, stenosis, and / or lesion. Generally, the composition of an obstruction depends on the type of anatomical structure being evaluated. Healthier parts of anatomical structures have a uniform or symmetrical shape (e.g., a cylindrical shape with a circular cross-section). An occlusion does not have a uniform or symmetrical shape. Therefore, the affected or compressed portion of an anatomical structure containing an occlusion has an asymmetrical and / or otherwise abnormal shape. An anatomical structure may contain one or more occlusions.

[0045]

[0070] The construction of an occlusion (for example, thrombosis, deep vein thrombosis, or DVT, chronic total occlusion, or CTO) is one situation in which the cross-sectional area of ​​a vein in a peripheral vascular structure (e.g., torso, abdomen, groin, leg) is reduced. Other anatomical structures in contact with a vein can further reduce its cross-sectional area, thereby restricting blood flow through the vein. For example, arteries or ligaments in the torso, abdomen, groin, or leg can compress a vein, which alters its shape and reduces its cross-sectional area. Such a reduction in cross-sectional area resulting from contact with other anatomical structures can be called compression, in that the vein wall is compressed as a result of contact with an artery or ligament.

[0046]

[0071] Figure 3 shows a blood vessel 300 containing a thrombus 330. The thrombus develops between the vascular walls 310 and restricts blood flow 320. There are many types of thrombi, including subacute thrombi, acute thrombi, and chronic thrombi.

[0047]

[0072] Figure 4 shows a blood vessel 300 containing a thrombus 330 and a stent 440 expanded within the vessel 300 to restore blood flow. The stent 440 compresses and restrains the thrombus 330, opening the blood vessel 300 and preventing the thrombus 330 from moving through the blood vessel 300. The stent 440 further pushes the vascular wall 310 outward, thus reducing the restriction of blood flow to 320. Other treatment options to alleviate the occlusion may include, but are not limited to, thrombectomy, ablation, vasoplasty, and drug use. However, in the vast majority of cases, it is highly desirable to obtain accurate and timely intravascular images of the affected area, along with accurate and detailed knowledge information about the location of the affected area before, during, or after the procedure. Inaccurate or ambiguous location information for IVUS images carries the risk, for example, of ablation or stent placement of healthy tissue instead of affected or compressed tissue during the procedure.

[0048]

[0073] Figures 5 to 23 show exemplary screen displays or graphical user interfaces (GUIs). The screen displays are generated in processor 106 and may be shown (e.g., displayed) on a display or monitor 108 of system 100, such as a console, cart, bedside control device, mobile device (e.g., smartphone, tablet, personal digital assistant, or PDA), laptop computer, or desktop computer display. Display 108 may be a touchscreen display. Display 108 may communicate with a computer or processing system 106, which includes processing circuits (e.g., one or more processors and memory). The processing circuits may generate and output display data to cause display 108 to show the screen displays of Figures 5 to 23. The computer, processing circuits, and / or processor 106 may further communicate with a user interface to which the user provides input. The input may be the selection of items in the screen display. In some cases, the user interface may be a touchscreen display. The user interface may be a keyboard, mouse, or control device, including buttons, joysticks, etc.

[0049]

[0074] Figures 5–9 show screen displays that provide guidance to clinicians during IVUS retraction in peripheral vascular structures. The screen displays provide users with greater clarity to more clearly visualize aspects of deep vein disease. The screen displays perform several functions, including highlighting segments of vascular structures, labeling segments, and color-coding segments, or differentiating segments and / or adjacent anatomical structures. The screen displays also automatically provide criteria and compression scales (e.g., lumen cross-sectional area, diameter, etc.) within each segment. Segments meeting specific criteria (e.g., a difference of 50% or more between the criterion and compression scale) are colored, highlighted, thickened, or marked with a different form (e.g., colored red) to indicate segments of clinical interest or concern. Furthermore, the screen displays provide real-time feedback to the user regarding the retraction speed. The GUI may further improve image quality by providing the ability to adjust contrast, gain, focus, and / or other image settings. Image quality can be further improved by providing feedback to the user to reach the correct retraction speed in order to acquire a sufficient amount of high-quality IVUS data. The screen display provides a direct map to anatomical structures, real-time live values ​​(reference, compressed measurement results), color-coded segment highlighting, and a retraction speed gauge (guidance).

[0050]

[0075] As shown, the screen displays in Figures 5–9 include a graphical representation of peripheral vascular structures (e.g., inferior vena cava, abdominal vena cava, renal vein, left and right common iliac veins, left and right common femoral veins, etc.) in which an intraluminal ultrasound device (e.g., IVUS catheter) is located. The graphical representation may be a diagram or cartoon representation of the vascular structure (e.g., a virtual or non-medical image venography) and / or an X-ray / CT / MRI image. For example, the graphical representation may be a roadmap image. The graphical representation may be formed from acquired IVUS images. The graphical representation shows the longitudinal extent of the vascular structure and may be called a longitudinal view or image longitudinal view (ILD).

[0051]

[0076] In some embodiments, a graphical representation of the IVUS catheter, including a flexible elongated member positioned within the vascular structure and a transducer array distal to the flexible elongated member, is further displayed. The position of the IVUS catheter within the vascular structure changes from Figure 5 to Figure 9 during imaging withdrawal. As shown in Figure 5, the IVUS catheter begins with a transducer array positioned within the inferior vena cava or abdominal vena cava. During withdrawal, the transducer array moves longitudinally within the vascular structure, through the left iliac vein (e.g., Figure 7) to the left femoral vein (e.g., Figure 9).

[0052]

[0077] In some embodiments, when the imaging catheter passes through or near important anatomical landmarks during the withdrawal recording, the user needs to mark these landmarks, such as the CIV, EIV, and CFV. In other embodiments, the system may automatically detect these landmarks based on image analysis. In some embodiments, the accuracy of the automated analysis can be further enhanced by introducing a step in which the user indicates the entry point (femoral, jugular vein, left / right leg) to the system before initiating the withdrawal. In some embodiments, the system may further detect and highlight nearby areas of interest as imaging progresses.

[0053]

[0078] Figure 5 shows a screen display of an exemplary cartoon roadmap or virtual venography diagram 500 at the start of the withdrawal process of the imaging catheter 510 in the inferior vena cava or abdominal vena cava 530, according to at least one embodiment of the present disclosure. A velocity indicator 520 is provided to provide guidance on the withdrawal speed. The withdrawal speed affects the amount of imaging data collected at locations along the longitudinal direction of the vascular structure and therefore affects the image quality of the IVUS image at those locations. Different colors, shading, text, numbers, etc., within the velocity indicator 520 may alert the user regarding whether to accelerate (move faster), decelerate (move slower), and / or maintain the speed during withdrawal. For example, velocity gauges with numbers are shown in Figures 5 to 9. All or part of the velocity gauge may be color-coded to guide the user. For example, in Figures 5, 6, and 7, a colored (e.g., green) highlighting on the velocity gauge indicates that the user's withdrawal speed is appropriate and should be maintained.

[0054]

[0079] In this example, the left and right common iliac veins (CIV) 540, the left and right external iliac veins (EIV) 550, the left and right common femoral veins (CFV) 560, and the left and right femoral veins (F) 570 are further visible. In other examples, other vascular structures may be visualized in place of or in addition to those shown in Figure 5.

[0055]

[0080] Figure 6 shows an exemplary cartoon roadmap or virtual venography 500 screen display during the withdrawal process of an imaging catheter 510 in the inferior vena cava, according to at least one embodiment of the present disclosure. In this example, the virtual venography 500 includes a text label 634 ("IVC") adjacent to the vascular structure to identify the inferior vena cava 530 as the segment of vascular structure currently occupied by the catheter 510, corresponding here to the highlighted segment of the virtual venography 500. For example, the label may be an abbreviation or full form of the name of the corresponding vascular structure segment.

[0056]

[0081] The screen display further automatically provides statistically representative reference values ​​636 associated with vascular structure segment 530 that are close to the vascular structure segment 530. The reference values ​​are, for example, expected values ​​for healthy blood vessels based on literature. The reference values ​​are values ​​for healthy blood vessels for a particular patient. For example, the reference values ​​are numerical values ​​for lumen cross-sectional area. The numerical values ​​shown in Figure 6 are illustrative and do not necessarily reflect values ​​associated with specific anatomical structures. In this example, the inferior vena cava or abdominal vena cava 530 is colored, shaded, and / or highlighted in the virtual venography figure 500, for example, by a first color (e.g., blue). The color for the IVC segment may differ from the colors associated with other vascular structure segments to indicate that the IVC segment is the starting point of the retraction. The segment color may further indicate that the compression scale has not been determined from the acquired IVUS data, or that the compression scale is equal to or approximately equal to the reference scale.

[0057]

[0082] Figure 7 shows a screen display of an exemplary virtual venography 500 after the transducer array 124 at the end of the catheter 510 has been moved into the left common iliac vein 540, according to at least one embodiment of the present disclosure. A text label 744 ("CIV") is provided adjacent to the vascular structure to identify the segment occupied by the transducer array as the left common iliac vein 540. Assuming the catheter is in the patient's right leg rather than the left leg, as in this example, the CIV 540 would be labeled in the left half of the virtual venography 500, and the CIV 540 in the right half of the virtual venography 500 would be left blank.

[0058]

[0083] In this example, as the transducer array 124 moves within the vascular structure, reference values ​​746 and compression values ​​748 associated with the CIV segment 540 are automatically provided to the screen display. For example, the compression value 748 is a numerical value or percentage compression of the lumen cross-sectional area for a particular patient. In this regard, the compression value is automatically calculated based on the acquired IVUS data and then output to a screen display adjacent to the virtual venography diagram 500. In this example, the CIV segment 540 is colored based on a comparison between the reference value and the compression value. For example, the comparison could be the ratio of the compression value 748 to the reference value 746 (e.g., the compression value divided by the reference value). In this example, the CIV segment 540 is colored in a different way than the IVC segment 540. For example, if the compression value 748 is less than 50% of the reference value 746, the segment may be colored with a second color (e.g., green) to indicate that the compression may be harmful to the patient. For comparison between the baseline value of 746 and the compressed value of 748, different colorings, shadings, and highlightings may be used (e.g., different colors for values ​​greater than 50%, less than 50%, between 0% and 25%, between 25% and 50%, between 50% and 75%, and between 75% and 100%).

[0059]

[0084] Two position indicators 710 and 720 marking the boundary of CIV segment 540 are further visible. As the withdrawal continues and the catheter 510 is withdrawn downward (i.e., distally in this example, or toward the patient's feet) through the vascular structure, the transducer array 124 eventually crosses the position indicator 720, and the transducer array 124 is no longer in CIV segment 540.

[0060]

[0085] Figure 8 shows a screen display of an exemplary cartoon roadmap or virtual venography diagram 500 after the transducer array 124 at the end of the catheter 510 has been moved into the left external iliac vein 550, according to at least one embodiment of the present disclosure. A text label 854 ("EIV") is provided adjacent to the vascular structure to identify the segment occupied by the transducer array 124 as the external iliac vein. A reference value 856 and a compression value 858 associated with the EIV segment are automatically provided and / or calculated. The EIV segment 550 is colored in a different form than the IVC segment 530 and CIV segment 540 based on a comparison between the reference value 856 and the compression value 858. For example, if the compression value is 50% or more of the reference value, the EIV segment may be colored in a third color (e.g., red) to indicate that the compression amount may be harmful to the patient.

[0061]

[0086] Figure 8 further shows the velocity gauge 520 indicating an excessively high pull-back speed. In this respect, a larger proportion of the velocity gauge is colored (compared to, for example, Figures 5-7) to indicate a higher pull-back speed. In this example, the velocity gauge 520 is colored (for example, red) to provide the user with real-time feedback that the pull-back speed must be reduced. Position markers 710 and 720 marking the proximal and distal boundaries of the EIV segment 550 are also visible here.

[0062]

[0087] Figure 9 shows a screen display of an exemplary virtual venography 500 after the transducer array 124 at the end of the catheter 510 has been moved into the left common femoral vein 560, according to at least one embodiment of the present disclosure. As the transducer array passes through the vascular structure segments, the vascular structure segments are successively highlighted in the virtual venography 500. A text label 964 ("CFV") is provided adjacent to the vascular structure to identify the segment occupied by the transducer array 124 of the catheter 510 as the common femoral vein 560. Reference values ​​966 and compression values ​​968 associated with the CFV segment 560 are automatically provided and / or calculated. The CFV segment 560 is colored in a different form than the IVC, CIV, and EIV segments based on a comparison between the reference value and the compression value. For example, if the compression value is greater than 50% of the reference value, the segment 560 may be colored in a fourth color (e.g., yellow) to indicate that the amount of compression or occlusion is not harmful to the patient.

[0063]

[0088] Here, position indicators 710 and 720 marking the proximal and distal boundaries of the right CFV segment 560 are further visible. In this example, the left femoral vein 570 is also labeled ("F"), but no reference value, compression value, or color is displayed because the transducer array 515 has not yet been retracted into the right F segment 570.

[0064]

[0089] Figure 10 is a screenshot 1000 of an exemplary IVUS system incorporating a virtual venography diagram 500 according to at least one embodiment of the present disclosure. The screenshot 1000 further includes a tomographic IVUS image 1010 and an IVUS image longitudinal display (ILD) 1020. In this example, the left side 1040 of the virtual venography diagram 500 is shown in a very muted color (e.g., dark gray against a black background) to indicate that the left side of the body is not being examined. The inferior vena cava 530, common iliac vein 540, and common femoral vein 560 are shown in a more visible color (e.g., lighter gray) to indicate that they are along the path of the current retraction process, and the external iliac vein 550 is highlighted in a color for emphasis (e.g., blue) (e.g., because the external iliac vein 550 is a segment containing a thrombus, compression, or other restriction).

[0065]

[0090] Position markers 1030 are displayed in both the virtual venography diagram 500 and the ILD 1020 to mark areas of interest where IVUS images will be bookmarked for later review. Position markers 1030a and 1030b are located in the right common iliac vein 540, position markers 1030c and 1030d are located in the right external iliac vein 550, and position markers 1030e and 1030f are located in the right common femoral vein 560.

[0066]

[0091] Figures 11 and 12 show screen displays that provide user guidance during and after IVUS withdrawal in peripheral vascular structures. The screen displays provide automatic labeling based on anatomical signage information (e.g., arterial bifurcation), automatic labeling based on image analysis, lateral bookmark thumbnails, a roadmap view (e.g., virtual venography or actual venography; actual venography may be correlated with tomographic image data), segment mapping, longitudinal and compression indicators, automatic labeling in all relevant areas, user-selected access points, image adjustments, and a withdrawal speed indicator.

[0067]

[0092] Figure 11A shows a screen display 1100 of a virtual venography at the start of a retraction process according to at least one embodiment of the present disclosure. In the graphical view of the vascular structure displayed in the virtual venography 500, as indicated by the start indicator 1110, the user indicates where in the anatomical structure the user should begin the retraction. This information serves as input to the IVUS retraction virtual venography system to assist the IVUS transducer array 124 in automatically identifying different venous segments 530, 540, 550, 560, and 570 as it passes through different venous segments 530, 540, 550, 560, and 570.

[0068]

[0093] Figure 11B shows a screen display 1100 of the live view during a retraction process according to at least one embodiment of the present disclosure. A virtual venography 500, which functions as a roadmap in the live view 1100, automatically indicates the location of the transducer array 124 within the body. In some embodiments, a colregistrated X-ray, CAT scan, or fluoroscopic image is used as a roadmap in place of or in addition to the virtual venography 500. The screen display 1100 further includes a live tomography IVUS image 1010. In addition, the screen display 1100 includes an image setting control unit 1120 (e.g., gain, field of view, etc.).

[0069]

[0094] Figure 12 shows a screen display 1100 during retraction, for example, during IVUS data recording, according to at least one embodiment of the present disclosure. A current frame indicator 1215 indicates the current location of the transducer array 124 of the catheter 510 in a cartoon roadmap or virtual venography 500 of the vascular structure. Label presets 1220 (e.g., abbreviations for vascular structure segments, e.g., CIV, EIV, CFV, etc.) are further provided. IVUS frames are automatically labeled based on image analysis. In this example, the current location of the transducer array is identified as the external iliac vein 550, and therefore the EIV label preset 1220 is highlighted or brightened. A retraction rate indicator 1230 provides guidance to the clinician or other user for a stable retraction rate. The retraction rate indicator 1230 may be a series of blocks colored based on rate (e.g., more blocks indicate a faster rate, and fewer blocks indicate a slower rate). The tomographic IVUS image 1010 shows the current frame, and an auto-label 1240 can be generated using image analysis with a label preset described in relation to the current frame indicator 1215, for example by abbreviations for vascular structure segments. A bookmark thumbnail 1250 appears when the user presses a bookmark option and / or label preset option. A direction indicator 1260 is further included, for example, indicating the orientation or direction of movement of the transducer array. Front (A), back (P), center (M), side (L), and / or other appropriate direction labels may be used. The direction indicator may include a compass arrow that moves based on the direction of movement. Anatomical structures of interest 1270 (e.g., thrombi) within the IVUS image 1010 may be colored, shaded, and / or highlighted.

[0070]

[0095] Figure 13 shows a screen display during the review of IVUS images acquired during retraction. The vascular structure roadmap, longitudinal image, or virtual venography diagram 500 shows all bookmarked frames and labels 1310 (e.g., abbreviations for vascular structure segments, target frame, reference frame, frame representing affected or compressed vascular structures, frame representing vascular structures requiring treatment, frame representing healthy vascular structures, etc.). The processing system 106 performs an automated image analysis of the acquired IVUS image data and calculates one or more metrics (e.g., lumen cross-sectional area, diameter, compression, plaque load, etc.). A graphical representation 1320 of the automatically calculated metrics is shown, for example, adjacent to the vascular structure, on the vascular structure roadmap image. For example, the graphical representation may be bars (e.g., in a bar graph) or a histogram representing values ​​corresponding to adjacent portions of the vascular structure. In some embodiments, two or more metrics may be displayed (e.g., by different colors). Alternative views 1330 of graphical representations of one or more scales are further shown. For example, the graphical representation extends in relation to length along the screen display rather than being adjacent to the vascular structure in the roadmap image. Any suitable graphical representation, e.g., line graphs, bar graphs, symbols, etc., may be used to represent the scale 1320 in the roadmap image, or alternative views 1330 of the scale. A tomographic IVUS image 1010 may be automatically assigned labels 1240 using image analysis with label presets (e.g., vascular structure segment name, reference frame, target frame, etc.). A tomographic IVUS image frame 1010 may further include visual representations 1340 of one or more calculated scales (e.g., lumen cross-sectional area, diameter values) for that image frame. A bookmark video thumbnail 1250 is provided in the screen display 1100 adjacent to the tomographic IVUS image 1010, for example. The user can click on a thumbnail 1250 to play the corresponding video containing multiple IVUS image frames 1010. The user can select a representative IVUS image frame 1010 from the video clip as a thumbnail.The thumbnail includes a label (e.g., the name of the vascular structure segment).

[0071]

[0096] Figures 14–16 show a screen display that provides user review of IVUS image data acquired during retraction in peripheral vascular structures. The screen display provides automatically indicated relevant scales, automatic detection of other elements if necessary, and longitudinal ILD.

[0072]

[0097] Figure 14 shows a screen display 1400 for reviewing IVUS image data according to at least one embodiment of the present disclosure. On the left side of the screen display, two IVUS image frames (e.g., a reference frame 1410 and a lesion frame 1420) are displayed. Upon completion of the retraction, the processing system 106 automatically calculates and displays the percentage of compression 1430 in the vascular structure segment using image analysis. The lesion length 1440 is further calculated and displayed using image analysis. Other measures 1450, e.g., the luminal cross-sectional area and / or diameter corresponding to the two frames, are further automatically calculated and displayed. In some cases, the average value is calculated and displayed. On the right side of the screen display, a correlated venography or virtual venography 500 is shown, indicating the vascular structure segment including the displayed IVUS image frames 1410 and 1420. Markers 1460 and 1470 are provided on the venography diagram 500 to indicate the locations of the reference IVUS image frame 1410 and the lesion IVUS image frame 1420. The right side of the screen display further includes a longitudinal ILD 1020 of the vascular structure segment. It should be understood that in other examples or embodiments, the longitudinal ILD 1020 may be located elsewhere in the screen display 1400. The longitudinal ILD 1020 may be made from the IVUS image frame 1010 acquired during retraction. A label (e.g., an abbreviation for the vascular structure segment, e.g., CIV) is further indicated. Markers are further provided on the longitudinal ILD to indicate the locations of the reference IVUS image frame and the lesion IVUS image frame.

[0073]

[0098] Figure 15 shows a screen display 1400 for reviewing IVUS image data according to at least one embodiment of the present disclosure. The user may click on the tomographic IVUS image frame 1410 or 1420 in Figure 14 to enlarge the tomographic IVUS image frame 1410 or 1420. For example, the lesion frame 1420 in Figure 14 is shown enlarged in Figure 15. The user may edit the measurement results in the enlarged IVUS image frame (for example, by selecting the lumen boundary using dots around the lumen, or by drawing lines around the lumen, or by oriented diameter lines). Direction labels 1510 (e.g., A, P, M, L) are provided around the IVUS image 1420. Markers 1470 indicating the position of the selected frame 1420 are provided on the venography diagram 500 and the longitudinal ILD 1020 on the right side of the screen display.

[0074]

[0099] Figure 16 shows a screen display 1400 for reviewing IVUS image data according to at least one embodiment of the present disclosure. The user may select a help option 1610 which causes a processing system 106 to automatically segment and / or label elements in the tomographic IVUS image 1420. For example, automatic segmentation identifies and labels the lumen boundaries of vascular structure segments 1620 (inferior vena cava or IVC) and shadows 1630 in the tomographic image 1420.

[0075]

[0100] Figures 17–19 show screen displays that provide user guidance during IVUS withdrawal in peripheral vascular structures. The screen displays provide a speed indicator for withdrawal, a speed gauge, a map of the vascular structure constructed during withdrawal (e.g., filling the map as it progresses), a display of directional labels (e.g., anterior), and / or arrows. Generally, the map or image of the vascular structure is a 2D or 3D graphical display.

[0076]

[0101] Figure 17 shows a screen display 1700 during retraction, for example, during IVUS data recording, according to at least one embodiment of the present disclosure. To the left of the screen display is shown a roadmap image, a correlated external image, or a virtual venography 500 of the vascular structure. Parts 1710 of the vascular structure 1720 from which IVUS data has already been collected are highlighted, colored, and / or shaded. For example, the boundaries of the vessels in the area 1710 from which retraction has already been performed are thickened, while other areas of the vessels 1720 are shown more lightly. Solid thick lines 1710 may be used for the boundaries of the vessels, while dashed thick lines 1124 may be used when crossing branched vessels. As retraction progresses, more and more vessels 1720 are visually highlighted 1710. In this regard, a map 500 of the vascular structure 1720 is constructed during retraction. As the transducer array 124 is moved longitudinally from the front 1730 to the rear 1740, the front (ANT) 1730 and rear (POST) 1740 of the vascular structure are labeled in the roadmap image 500 as the retraction occurs. A transverse ILD 1020 is shown along the bottom of the display. It should be understood that in other examples or embodiments, the transverse ILD 1020 may be located elsewhere in the screen display 1700. The ILD 1020 is formed from IVUS data during the retraction. As shown, the ILD 1020 is further constructed during the retraction, with more and more IVUS image frames 1010 being added to the ILD 1020 as the retraction progresses. The front (ANT) 1730 and rear (POST) 1740 of the vascular structure 1720 are labeled in the roadmap image 500. A compass 1260 is provided in the center of the screen display 1700, although the compass 1260 may be located in other positions on the screen display 1700. For example, forward (ANT) may always be located at the top (e.g., at the 12 o'clock position). The compass arrow 1260 may change direction based on the orientation or direction of movement of the transducer array within the vascular structure 1720 during retraction. A retraction speed indicator 520 is provided in the upper right of the screen display.The pull-back speed indicator 520 may display the manual pull-back speed with a numerical value. The indicator may further include a graphical representation (e.g., a symbol) of whether the speed is too fast, too slow, or correct. For example, a checkmark may indicate that the pull-back speed is correct.

[0077]

[0102] Figure 18 shows an exemplary screen display 1700 in the subsequent stages of IVUS retraction according to at least one embodiment of the present disclosure. As shown in the virtual venography diagram 500 on the left side of screen display 1700, the longer lengths of the vascular structure 1720 are highlighted compared to Figure 17 to indicate that IVUS data was acquired from a longer length of the vascular structure 1720 (1710, 1124). Similarly, the longer length of the ILD 1020 is filled with the acquired IVUS image frame 1010. If the computer or processor is uncertain about the direction in which the transducer array 124 is moving or oriented within the vascular structure, or if the direction / orientation is being recalculated, the direction label (ANT) or arrow on the compass 1260 may flash.

[0078]

[0103] Figure 19 shows an exemplary screen display 1700 at or near the end of an IVUS retraction according to at least one embodiment of the present disclosure. As shown in the virtual venography diagram 500 on the left side of the screen display 1700, all or nearly all of the length of the vascular structure under investigation 1720 is highlighted (1710, 1124) to indicate that the IVUS data 1010 was acquired from nearly its entire length. Similarly, all or nearly all of the length of the ILD 1020 is filled with the acquired IVUS image frame 1010. A retraction speed indicator 520 in the upper right of the screen display 1700 indicates that the retraction speed is excessively high. For example, symbols (e.g., exclamation marks) and / or coloring of the speed value numerically (e.g., red) may be used to indicate to the user that the retraction speed should be slowed down.

[0079]

[0104] Figure 20 is a screenshot of the IVUS access point selection screen 2000 according to at least one embodiment of the present disclosure. IVUS retraction virtual venography systems are generally capable of automatically identifying different regions of a patient's circulatory system by using machine learning algorithms or other training-based AI algorithms to match IVUS images against an a priori data set or knowledge information set of statistically representative anatomical structures of lumens for different human subpopulations. However, the accuracy of vascular identification is improved when the IVUS retraction virtual venography system starts based on precise and specific information regarding the starting point and direction of movement of the ultrasound transducer 124 of the imaging catheter 510. Therefore, in this example, the screen display 2000 includes an access point selection unit 2010 that allows a clinician or other user to select between femoral access and jugular vein access. The screen display 2000 further includes a target limb selection unit 2020 that allows a clinician or other user to select between the patient's right and left legs as the IVUS retraction location. These examples are illustrative, and other access points and target limbs or regions are possible and may be used alternatively or additionally depending on the type of process, disease type, and location of the anatomical features of interest.

[0080]

[0105] The end button 2030 and the start button 2040 are further visible. Other control units may be provided, including but not limited to a help button, a process type selection unit, a disease type selection unit, and an anatomical structure type selection unit.

[0081]

[0106] Figure 21 is a screenshot of a user guidance screen display 2100 according to at least one embodiment of the present disclosure. The tomographic IVUS image 1010 and the guidance pane 2110 are visible. In this example, the guidance pane 2110 displays specific instructions 2115 to the user regarding the operation of both the imaging catheter 510 and the IVUS retraction virtual venography system. These instructions 2115 reduce the training and memory burden on the clinician or other user by reducing the need to be familiar with the specifications of a given system.

[0082]

[0107] Figure 22 is a screenshot of the retraction navigation and marking display 2200 according to at least one embodiment of the present disclosure. The screen display 2200 includes a live tomographic IVUS image 1010, an image longitudinal display (ILD) 1020, a virtual venography diagram 500, a retraction speed indicator 520, a user instruction 2210, and a labeling button 2220. In this example, when the retraction of the ultrasound transducer array 124 reaches the start of the common iliac vein, the user instruction 2210 instructs the user to click the labeling button 2220. In some embodiments, the IVUS retraction virtual venography system automatically identifies the start and end of different vascular structure segments, so this selection is optional. In another embodiment, the IVUS retraction virtual venography system allows a clinician or other user to select the start or end marking of a vascular structure segment through voice, gesture, or other non-contact instructions, so as not to require a non-sterilized staff member to operate a keyboard, mouse, joystick, or other non-sterilized input device.

[0083]

[0108] In this example, IVUS image 1010 shows a branched artery 2230 and a branched vein 2240. The size and location of these branches may be important to image recognition algorithms for identifying the beginning and end of different vascular structural segments within the patient's body.

[0084]

[0109] Figure 23 is a screenshot of the pullback navigation and marking display 2200 according to at least one embodiment of the present disclosure. A live tomography IVUS image 1010, an image longitudinal display (ILD) 1020, a virtual venography diagram 500, a pullback speed indicator 520, a single-line user instruction 2210, a labeling button 2220, an artery 2230 (which is no longer branched but connected in this case to a single lumen), and a branched vein 2240 are visible. In this example, the common iliac vein (CIV) 540 is marked and highlighted in the virtual venography diagram to indicate that the common iliac vein (CIV) 540 is a segment of the patient's vascular structure currently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked with a different color (e.g., light gray) to indicate that it is the next segment into which the imaging array 124 will enter. To indicate that the remaining portion of the right bundle branch vascular structure 1720 is not currently involved in the retraction process, the remaining portion of the right bundle branch vascular structure 1720 is marked with a dotted line, while to indicate that the left bundle branch vascular structure is not involved in the retraction process at all, the left bundle branch vascular structure is grayed out (for example, displayed in a gray color close to the background color).

[0085]

[0110] Figure 24 shows a flowchart for an exemplary intraluminal direction guidance method 2400 according to an aspect of the present disclosure. It is understood that the steps of method 2400 may be performed in a different order than that shown in Figure 13, that further steps may be provided before, during, and after the steps, and / or that some of the steps described may be replaced or omitted in other embodiments. These steps are performed in response to input from a clinician or other user, for example, as coded instructions in a processor such as the processing system 106 in Figure 1, and displayed on, for example, the monitor 108 in Figure 1.

[0086]

[0111] In step 2410, the user initializes the intraluminal directional guidance system using directional information at the start of a process (e.g., an IVUS retraction process), as shown in Figure 20, for example. This information includes, for example, entry points or access points into the body (e.g., jugular vein, radius, right femur, or left femur), and target anatomical structures or directions of movement. This information is used by the system to select specific algorithms, data sets, or body regions for image recognition.

[0087]

[0112] In step 2420, the IVUS imaging system 100 captures IVUS images. Such images are captured discretely or sequentially during the process (e.g., the retraction process) and stored in the memory of the processing system 106.

[0088]

[0113] In step 2430, the processor 106 performs boundary detection, image processing, image analysis, and pattern recognition of the captured IVUS image to identify anatomical landmarks (e.g., specific veins and branching points between veins). While the pullback operation is being performed, the algorithm detects these landmarks based on a priori information of the venous system shape. Such analysis and recognition may rely on prior art or be training-based or learning-based (e.g., encompassing machine learning, deep learning, or other relevant artificial intelligence). In some embodiments, information from external images is incorporated into the image recognition algorithm where available so that the unique anatomical structure of the patient itself is taken into account. In other embodiments or situations, the pattern recognition algorithm may search for analogues of statistically representative luminal anatomical structures for a given subpopulation, or such statistically representative luminal anatomical structures are used to train one or more algorithms. Examples of boundary detection, image processing, image analysis, and / or pattern recognition include U.S. Patent No. 6,200,268, issued March 13, 2001, “VASCULAR PLAQUE CHARACTERIZATION,” by D. Geoffrey Vince, Barry D. Kuban, and Anuja Nair; U.S. Patent No. 6,381,350, issued April 30, 2002, “INTRAVASCULAR ULTRASONIC ANALYSIS USING ACTIVE CONTOUR METHOD AND SYSTEM,” by Jon D. Klingensmith, D. Geoffrey Vince, and Raj Shekhar; and “SYSTEM AND METHOD OF CHARACTERIZING VASCULAR,” issued July 11, 2006, by Anuja Nair, D. Geoffrey Vince, Jon D. Klingensmith, and Barry D. Kuban. U.S. Patent No. 7,074,188, with the invention title "TISSUE", by D. Geoffrey Vince, Anuja Nair, and Jon D.U.S. Patent No. 7,175,597, issued on February 13, 2007, with the invention title "NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD," with Klingensmith as the inventor; U.S. Patent No. 7,215,802, issued on May 8, 2007, with the invention title "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," with Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince as the inventors; U.S. Patent No. 7,359,554, issued on April 15, 2008, with the invention title "SYSTEM AND METHOD FOR IDENTIFYING A VASCULAR BORDER," with Jon D. Klingensmith, D. Geoffrey Vince, Anuja Nair, and Barry D. Kuban as the inventors; and Jon This includes U.S. Patent No. 7,463,759, published on December 9, 2008, with the title of the invention being "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," with inventors D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince; the teachings of these documents are incorporated herein by reference in their entirety.

[0089]

[0114] In step 2440, the processor presents the identified anatomical labels, or other results of the image analysis, such as boundaries, segments, etc., to the user as annotations or overlays on the live image data displayed on monitor 108, for example.

[0090]

[0115] In step 2450, the processor 106 is capable of accepting optional further input from the user, including information to assist the pattern recognition algorithm. For example, if the user believes that the identification result display in step 2440 is incorrect, incomplete, misplaced, or otherwise requires correction, the user may optionally correct this information using a keyboard, mouse, joystick, trackball, or other user input device that is communicatively connected to the processing system 106.

[0091]

[0116] In step 2460, if the user entered such a modification during step 2550, the processing system 106 updates the information located within the algorithm to reflect the modification. Optionally, the processing system 106 may upload the modification to a central server, cloud server, or other remote site so that the modification can be incorporated into a new training set for the machine learning algorithm and then distributed to other users.

[0092]

[0117] In step 2470, the processing system updates the virtual venography diagram 500 to show the current and previous positions of the imaging probe, for example, as shown in Figures 5 to 10, 12 to 19, and 22 to 23.

[0093]

[0118] In step 2480, the processing system 106 displays the colregistrated image on the display if available and if the user selects to display the colregistrated image on the display based on appropriate user input (e.g., the colregistration button 656 shown in Figure 6). Such colregistrated image may include, for example, images captured by the external imaging system 132 and showing vascular structures or other anatomical structures in the vicinity of the intravascular imaging probe 102, such as X-ray, fluoroscopy, CAT scan, external ultrasound, or other images.

[0094]

[0119] In some embodiments, the correlated images are incorporated into an image recognition algorithm, if available.

[0095]

[0120] In step 2490, if appropriate user input is selected, the processing system 106 provides the clinician with guidance related to the movement of the intravascular imaging probe control unit 104 required to advance or retract the probe 102 to a desired position in the patient's body, or to mark the start or end of a given vascular segment, or to start or stop recording. Such guidance is determined through prior art (e.g., database lookup) or through learning-based techniques.

[0096]

[0121] Those skilled in the art will understand that, for some embodiments, one or more of the steps described above may be omitted or carried out in a different sequence, and that other steps may be added. For example, in some embodiments, the system operates in a fully autonomous mode without requiring user input. In some embodiments, the image recognition and label identification algorithms incorporate information from external images. In some embodiments, the system does not require external images to provide orientation information or clinician roadmaps, allowing IVUS to be used independently.

[0097]

[0122] In some embodiments, the system may further automatically detect and highlight nearby markers (e.g., arteries or other vessels not under investigation) or other areas of interest (e.g., stenosis in nearby vessels) as imaging progresses. Overall, the above features enable the system to group and label all IVUS frames between markers as belonging to a specific named segment of the patient's vascular structure. Thus, the system automatically calculates relevant measures for diagnosis for that segment, such as compression, highlights areas of interest, and indicates the relative anatomical location of the IVUS frames. In other embodiments, users may bookmark confluences, reference points, and healthy areas via voice prompts, thus eliminating the need for non-sterilized staff members to press buttons on a touchscreen.

[0098]

[0123] In other embodiments, the virtual venography is a 3D reconstruction of the anatomical structure of the actual patient's blood vessels obtained by segmentation from a CT or MR vascular angiography study. This data can be loaded from a hospital image archiving and communication system (PACS) into an IVUS system, which may offer the advantage of considering the actual patient's anatomical structure and, consequently, the correct location of the vascular segments. In other embodiments, if coregistration between IVUS and a fluoroscopy system is enabled, the segments are automatically labeled on the fluoroscopy screen. Applications for the IVUS retraction virtual venography system include IVUS education, the use of IVUS systems for treating peripheral vascular (PV) diseases, and linking to other vascular navigation and visualization systems, such as Philips Vascular Navigator.

[0099]

[0124] Figure 25 is a schematic diagram of a processor circuit 2550 according to an embodiment of the present disclosure. The processor circuit 2550 is implemented in an ultrasound imaging system 100 or other device or workstation (e.g., a third-party workstation, network router, etc.) or in a cloud processor or other remote processing unit, as necessary for carrying out the present method. As shown, the processor circuit 2550 includes a processor 2560, memory 2564, and a communication module 2568. These elements communicate with each other directly or indirectly, for example, via one or more buses.

[0100]

[0125] The processor 2560 includes central processing units (CPUs), digital signal processors (DSPs), ASICs, control devices, or any combination of general-purpose computing devices, including mechanical and quantum computers, reduced instruction set arithmetic (RISC) devices, application-specific integrated circuits (ASICs), field-programmable gate arrays (FPGAs), or other related logic devices. The processor 2560 further comprises other hardware devices, firmware devices, or any combination thereof configured to perform the operations described herein. The processor 2560, in combination with a DSP core, or any other such configuration, is realized as a combination of computing devices, for example, a DSP and a microprocessor, multiple microprocessors, or a combination of one or more microprocessors.

[0101]

[0126] Memory 2564 includes cache memory (e.g., the cache memory of processor 2560), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable and programmable read-only memory (EPROM), electrically erasable and programmable read-only memory (EEPROM), flash memory, solid-state memory devices, hard disk drives, other forms of volatile and non-volatile memory, or combinations of different types of memory. In one embodiment, memory 2564 includes a non-temporary computer-readable medium. Memory 2564 stores instructions 2566. Instructions 2566, when executed by processor 2560, include instructions that cause processor 2560 to perform the operations described herein. Instructions 2566 are also called code. The terms “instruction” and “code” should be interpreted broadly to include any type of computer-readable statement. For example, the terms “instruction” and “code” may refer to one or more programs, routines, subroutines, functions, processes, etc. "Instruction" and "code" encompass one computer-readable statement or many computer-readable statements.

[0102]

[0127] The communication module 2568 may include any electronic and / or logic circuits to facilitate direct or indirect data communication between the processor circuit 2550 and other processors or devices. In this regard, the communication module 2568 may be an input / output (I / O) device. In some cases, the communication module 2568 facilitates direct or indirect communication between various elements of the processor circuit 2550 and / or the ultrasonic imaging system 100. The communication module 2568 communicates within the processor circuit 2550 through many methods or protocols. Serial communication protocols include US SPI, I 2This may include, but is not limited to, C, RS-232, RS-485, CAN, Ethernet, ARINC429, MODBUS, MIL-STD-1553, or any other suitable method or protocol. Parallel protocols include, but are not limited to, ISA, ATA, SCSI, PCI, IEEE-488, IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communications are bridged by a UART, USART, or other suitable subsystem.

[0103]

[0128] External communications (including, but not limited to, software updates, firmware updates, preset sharing between the processor and the central server, or readings from ultrasonic devices) are implemented using any suitable wireless or wired communication technology, such as cable interfaces, e.g., USB, micro USB, Lightning, or FireWire interfaces; Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections, e.g., 2G / GSM, 3G / UMTS, 4G / LTE / WiMAX, or 5G. For example, a Bluetooth Low Energy (BLE) radio may be used to establish connectivity with cloud services for data transmission and for receiving software patches. The control unit may be configured to communicate with a remote server or a local device, e.g., a laptop, tablet, or handheld device, or may include a display capable of showing status variables and other information. The information is transferred on a physical medium 610, such as a USB flash drive or memory stick.

[0104]

[0129] Many modifications are possible in the examples and embodiments described above. For example, the IVUS retraction virtual venography system may be used in internal anatomical systems other than those described, or for imaging other disease types, object types, or process types other than those described. The techniques described herein are applicable to a wide variety of intraluminal imaging sensors, whether currently existing or to be developed in the future.

[0105]

[0130] Accordingly, the logical operations that realize embodiments of the technology described herein may be referred to in various forms such as operations, steps, objects, elements, components, or modules. Furthermore, it should be understood that these may be performed in any order unless otherwise expressly stated in the claims and unless a particular order is essentially required by the language of the claims. For example, all directional expressions such as up, down, inward, outward, upward, downward, left, right, lateral, front, back, upper, bottom, upward, downward, vertical, horizontal, clockwise, counterclockwise, proximal, and distal are used solely for identification purposes to aid the reader's understanding of the subject matter described in the claims and do not imply any limitation on the position, orientation, or use of the IVUS retraction virtual venography system in particular. For example, expressions of connection such as attached, joined, connected, and linked may be interpreted broadly and may include intermediate members between a group of elements and relative movement between elements unless otherwise stated. Accordingly, expressions of connection are not limited to implying that two elements are directly connected and have a fixed relationship with one another. The term "or" shall be interpreted as meaning "and / or" and not "exclusive OR". Unless otherwise stated in the claims, the values ​​stated shall be interpreted as illustrative only and not as limiting.

[0106]

[0131] The above description, examples, and data provide a sufficient description of the structure and use of exemplary embodiments of the IVUS retraction virtual venography system as defined in the claims. However, although various embodiments of the subject matter described in the claims have been described in particular detail or by reference to one or more individual embodiments, a person skilled in the art can make many alternative examples to the disclosed embodiments without departing from the spirit or scope of the subject matter described in the claims. Further different embodiments are conceivable. All content included in the above description and shown in the accompanying drawings is intended to be construed as merely illustrative of a particular embodiment, and not limiting. Modifications of detail or structure may be made without departing from the basic elements of the subject matter defined in the claims below.

Claims

1. An intraluminal imaging system comprising a processor circuit for communication with an intraluminal imaging catheter, wherein the processor circuit is While the intraluminal imaging catheter is positioned within the patient's body lumen, which comprises multiple segments, the intraluminal images acquired by the intraluminal imaging catheter are received. Anatomical labels are detected based on the image analysis of the intraluminal image. Of the plurality of segments, the segment in which the intraluminal imaging catheter was located when the intraluminal image was acquired is identified based on the anatomical label. A screen display including a typical diagram of the body lumen including the plurality of segments, and an indicator identifying the segment in the typical diagram where the intraluminal imaging catheter was located when the intraluminal image was acquired, is output to a display that communicates with the processor circuit. Intraluminal imaging system.

2. The screen display further includes markers indicating the proximal and distal boundaries of one or more segments among the plurality of segments in the standardized figure. The intraluminal imaging system according to claim 1.

3. The screen display further includes markers indicating points of interest in the standardized figure. The intraluminal imaging system according to claim 1.

4. The screen display further includes one or more labels that identify one or more segments in the standardized figure, The intraluminal imaging system according to claim 1.

5. The screen display further includes a position indicator showing the position within the segment in the standard diagram where the intraluminal imaging catheter was located when the intraluminal image was acquired. The intraluminal imaging system according to claim 1.

6. The processor circuit identifies the multiple segments in the standard diagram sequentially as the intraluminal imaging catheter moves through the multiple segments. The intraluminal imaging system according to claim 1.

7. The processor circuit automatically labels the multiple segments that are sequentially identified in the standard diagram. The intraluminal imaging system according to claim 6.

8. The processor circuit automatically annotates the plurality of segments, which are successively identified by statistically representative reference values ​​associated with the corresponding segments, in the standardized diagram. The intraluminal imaging system according to claim 6.

9. The processor circuit automatically annotates the sequentially identified segments in the standard diagram based on automatically measured or calculated values ​​associated with the corresponding segments. The intraluminal imaging system according to claim 8.

10. The processor circuit colors the sequentially identified plurality of segments based on the ratio of the automatically measured or calculated value to the statistically representative reference value. The intraluminal imaging system according to claim 9.

11. The processor circuit receives user input representing the location where the intraluminal imaging catheter was positioned when the intraluminal image was acquired. The intraluminal imaging system according to claim 1.

12. The processor circuit automatically determines, based on the intraluminal image, the location where the intraluminal imaging catheter was positioned when the intraluminal image was acquired. The intraluminal imaging system according to claim 1.

13. The screen display further includes at least one of the following: a longitudinal display of the body lumen, a velocity indicator related to the movement of the intraluminal imaging catheter, or instructions for the user. The intraluminal imaging system according to claim 1.

14. The intraluminal imaging catheter further comprises the above-mentioned intraluminal imaging catheter. The intraluminal imaging system according to claim 1.

15. The processor circuit of an intraluminal imaging system comprising a processor circuit for communication with an intraluminal imaging catheter, A step of receiving intraluminal images acquired by an intraluminal imaging catheter while the intraluminal imaging catheter is positioned in a patient's body lumen, wherein the body lumen comprises a plurality of segments, The steps include detecting anatomical labels based on the image analysis of the intraluminal image, The steps include identifying, based on the anatomical label, the segment in which the intraluminal imaging catheter was located when the intraluminal image was acquired, among the plurality of segments; A computer program for causing a computer to perform the step of outputting a screen display to a display that communicates with the aforementioned processor circuit, The aforementioned screen display is A typical diagram of the body lumen including the aforementioned multiple segments, Includes an indicator that identifies the segment in the standard diagram where the intraluminal imaging catheter was located when the intraluminal image was acquired, Computer program.

16. An intravascular imaging system for use in peripheral vascular structures, wherein the intravascular imaging system is An intravascular imaging catheter that acquires intravascular images while the intravascular imaging catheter is positioned within a patient's peripheral blood vessel, wherein the peripheral blood vessel comprises a plurality of segments, A processor circuit for communication with the intravascular imaging catheter, The processor circuit comprises, The intravascular image acquired by the intravascular imaging catheter is received, Anatomical labels are detected based on the image analysis of the intravascular images. Of the plurality of segments, the segment in which the intravascular imaging catheter was located when the intravascular image was acquired is identified based on the anatomical label. The screen display is output to a display that communicates with the processor circuit, and the screen display is, A typical diagram of the peripheral blood vessel including the aforementioned multiple segments, An indicator that identifies the segment in the standard diagram where the intravascular imaging catheter was located when the intravascular image was acquired, including, To output, Intravascular imaging system.

Images