Intraluminal ultrasound navigation guidance and related equipment, systems and methods

Abstract

An intraluminal ultrasound imaging system is disclosed, comprising: a processor circuit in communication with an intraluminal ultrasound imaging catheter and configured to: receive an intraluminal ultrasound image from the imaging catheter in a body cavity of a patient, the body cavity comprising a plurality of segments. The processor is configured to: identify a segment in the plurality of segments where the imaging catheter was located when the image was acquired; and output to a display a stylized graphic of the body cavity comprising the plurality of segments and an indicator identifying the segment in the stylized graphic where the imaging catheter was located when the image was acquired.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 750,983, filed on October 26, 2018, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The subject matter described herein relates to systems for medical imaging. Specifically, the present disclosure describes aspects related to the acquisition, display, recognition and annotation of peripheral intravascular ultrasound or IVUS images and navigation assistance to clinicians during image acquisition. The system has particular but non-exclusive use in the diagnosis and treatment of vascular disease. Background Art

[0004] Various types of intraluminal imaging systems are used to diagnose and treat disease. For example, intravascular ultrasound (IVUS) imaging is used as a diagnostic tool for visualizing blood vessels within a patient's body. This can assist in assessing diseased or compressed blood vessels (such as arteries or veins within the human body), determining the need for treatment, optimizing treatment, and / or assessing the effectiveness of treatment.

[0005] Different diseases or medical procedures produce physical features with different sizes, structures, densities, water contents, and accessibility to imaging sensors. For example, deep vein thrombosis (DVT) produces clots of blood cells, while post-thrombotic syndrome (PTS) produces webbing or other residual structural effects in the blood vessels that have a composition similar to the vessel wall itself and may therefore be difficult to distinguish from the vessel wall. A stent is a dense (e.g., metal) object that can be placed in a blood vessel or lumen to keep the blood vessel or lumen open to a specific diameter. In some cases, intraluminal imaging is performed using an IVUS device that includes one or more ultrasonic transducers. The IVUS device can be delivered into a blood vessel and guided to the area to be imaged. The transducer transmits ultrasonic energy and receives ultrasonic echoes reflected from the blood vessel. The ultrasonic echoes are processed to create an image of the blood vessel of interest. The image of the blood vessel of interest may include one or more lesions or blockages in the blood vessel. Stents can be placed in blood vessels to treat these blockages, and intraluminal imaging can be performed to view the placement of the stent in the blood vessel. Other types of treatment include thrombectomy, ablation, angioplasty, medications, etc.

[0006] When using IVUS to treat peripheral vascular (PV) disease, it is often the vascular surgeon who instructs non-sterile staff to operate the IVUS console while handling the IVUS catheter. During a procedure (eg, a pullback procedure), the vascular surgeon often instructs the non-sterile operator to bookmark key anatomical landmarks for post-IVUS pullback analysis.

[0007] Post-IVUS Pullback Analysis Accurately labeling and measuring all segments and keyframes within segments can be a tedious task for non-sterile (and often non-IVUS expert) staff. However, accurate measurement and labeling are important for auditing, compensation, record keeping, and optimal treatment planning.

[0008] The information included in this background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and should not be construed as binding upon the subject matter of the scope of the present disclosure. Summary of the invention

[0009] A system for calculating, displaying and marking the position of an intravascular imaging probe during an IVUS pullback or other intraluminal procedure that requires accurate knowledge of the position of each IVUS frame within the vascular system is disclosed. Specifically, in accordance with at least one embodiment of the present disclosure, a system is provided for identifying, displaying and recording segments of a patient's vascular system associated with live IVUS images captured within the vascular system. This is particularly useful during manually controlled intravascular procedures that require detailed knowledge of the position of the imaging probe. The system helps make the association between IVUS frames and anatomical structures easier to understand and provides position navigation information by visually highlighting segments in arteries or vessels that require attention. The system can be referred to as an IVUS pullback virtual venography system. The IVUS pullback virtual venography system disclosed herein has specific, but not exclusive utility for intraluminal ultrasound imaging procedures.

[0010] The IVUS pull-back virtual venography system includes an intraluminal ultrasound imaging system, including: a processor circuit configured to communicate with an intraluminal ultrasound imaging catheter, wherein the processor circuit is configured to: receive an intraluminal ultrasound image obtained by the intraluminal ultrasound imaging catheter when the intraluminal ultrasound imaging catheter is located in a body cavity of a patient, the body cavity including multiple segments; identify the segment in the multiple segments where the intraluminal ultrasound imaging catheter is located when the intraluminal ultrasound image is obtained; and output a screen display to a display communicating with the processor circuit, the screen display including: a stylized graphic of the body cavity including the multiple segments; and an indicator identifying the segment in the stylized graphic where the intraluminal ultrasound imaging catheter is located when the intraluminal ultrasound image is obtained.

[0011] Implementations may include one or more of the following features. The system, wherein the screen display further comprises: a marker indicating a proximal boundary and a distal boundary of one or more of the plurality of segments in the stylized graphic. The system, wherein the screen display further comprises: a marker indicating a location of interest in the stylized graphic. The system, wherein the screen display further comprises: one or more labels, respectively identifying one or more segments in the stylized graphic. The system, wherein the screen display further comprises: a position indicator indicating a location within the segment in the stylized graphic where the intraluminal ultrasound imaging catheter was located when the intraluminal image was acquired. The system, wherein the processor circuit is configured to sequentially identify the plurality of segments in the stylized graphic as the intraluminal ultrasound imaging catheter moves through the plurality of segments. The system, wherein the processor circuit is configured to automatically mark the plurality of segments that are sequentially identified in the stylized graphic. The system, wherein the processor circuit is configured to automatically annotate the plurality of segments that are sequentially identified in the stylized graphic with statistically representative reference values ​​associated with the corresponding segments. The system, wherein the processor circuit is configured to automatically annotate the sequentially identified multiple segments with automatically measured or calculated values ​​associated with the corresponding segments in the stylized graphic. The system, wherein the processor circuit is configured to color the sequentially identified multiple segments based on the ratio of the automatically measured or calculated values ​​to a statistically representative reference value. The system, wherein the processor circuit is configured to receive user input indicating where the intraluminal ultrasound imaging catheter was located when the intraluminal ultrasound image was obtained. The system, wherein the processor circuit is configured to automatically determine where the intraluminal ultrasound imaging catheter was located when the intraluminal ultrasound image was obtained based on the intraluminal ultrasound image. The system, wherein the screen display also includes at least one of the following: a longitudinal display of the body cavity, a speed indicator associated with the movement of the intraluminal ultrasound imaging catheter, or instructions to the user. The system also includes: an intraluminal ultrasound imaging catheter. Implementations of the described technology may include hardware, methods or processes, or computer software on a computer-accessible medium.

[0012] A general aspect includes a method of intraluminal ultrasound imaging, comprising: receiving, at a processor circuit in communication with an intraluminal ultrasound imaging catheter, an intraluminal ultrasound image obtained by an intraluminal ultrasound imaging catheter while the intraluminal ultrasound imaging catheter is located in a body cavity of a patient, the body cavity comprising a plurality of segments; and using the processor circuit to identify a segment of the plurality of segments in which the intraluminal ultrasound imaging catheter was located when the intraluminal ultrasound image was obtained; and outputting a screen display to a display in communication with the processor circuit, the screen display comprising: a stylized graphic of the body cavity including the plurality of segments; and an indicator identifying the segment of the stylized graphic in which the intraluminal ultrasound imaging catheter was located when the intraluminal ultrasound image was obtained. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each of which is configured to perform the actions of the method.

[0013] A general aspect includes an intravascular ultrasound imaging system for use in a peripheral vascular system, the system comprising: an intravascular ultrasound imaging catheter configured to obtain an intravascular ultrasound image when the intravascular ultrasound imaging catheter is located in a peripheral blood vessel of a patient, the peripheral blood vessel comprising a plurality of segments; a processor circuit configured to communicate with the intravascular ultrasound imaging catheter, wherein the processor circuit is configured to: receive an intravascular ultrasound image obtained by the intravascular ultrasound imaging catheter; identify a segment of the plurality of segments in which the intravascular ultrasound imaging catheter is located when the intravascular ultrasound image is obtained; and output a screen display to a display in communication with the processor circuit, the screen display comprising: a stylized graphic of the peripheral blood vessel including the plurality of segments; and an indicator identifying the segment of the stylized graphic in which the intravascular ultrasound imaging catheter is located when the intravascular ultrasound image is obtained. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each of which is configured to perform the actions of the method.

[0014] This summary is provided to introduce some concepts in a simplified form, which are further described in the detailed description below. This summary is neither intended to identify key features or essential features of the claimed subject matter nor to limit the scope of the claimed subject matter. A broader presentation of the features, details, practicability, and advantages of the IVUS pullback virtual venography system as defined in the claims is provided in the following written description of various embodiments of the present disclosure and illustrated in the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, in which:

[0016] Figure 1is a schematic illustration of an intraluminal imaging system according to aspects of the present disclosure.

[0017] Figure 2 Blood vessels (eg, arteries and veins) in the human body are illustrated.

[0018] Figure 3 A blood vessel containing a thrombus is shown.

[0019] Figure 4 The diagram shows a blood vessel containing a thrombus and within which a stent has been expanded to restore blood flow.

[0020] Figure 5 A screen display of an exemplary cartoon roadmap or virtual venogram at the beginning of a pullback procedure of an imaging catheter in the inferior vena cava or abdominal vena cava is shown in accordance with at least one embodiment of the present disclosure.

[0021] Figure 6 A screen display of an exemplary cartoon roadmap or virtual venogram during a pullback procedure of an imaging catheter in the inferior vena cava is shown in accordance with at least one embodiment of the present disclosure.

[0022] Figure 7 Illustrated is a screen display of an exemplary virtual venogram after the transducer array at the tip of the catheter has been moved into the left common iliac vein in accordance with at least one embodiment of the present disclosure.

[0023] Figure 8 Illustrated is a screen display of an exemplary cartoon roadmap or virtual venogram after the transducer array at the tip of the catheter has been moved into the left external iliac vein in accordance with at least one embodiment of the present disclosure.

[0024] Fig. 9 Illustrated is a screen display of an exemplary virtual venogram after the transducer array at the tip of the catheter has been moved into the left common femoral vein in accordance with at least one embodiment of the present disclosure.

[0025] Fig.10 is a screenshot of an exemplary IVUS system incorporating a virtual venogram in accordance with at least one embodiment of the present disclosure.

[0026] Fig.11A An on-screen display of a virtual venogram at the beginning of a pullback procedure is illustrated in accordance with at least one embodiment of the present disclosure.

[0027] Fig. 11B Illustrated is a screen display of a live view during a pullback procedure in accordance with at least one embodiment of the present disclosure.

[0028] Fig.12Screen displays during pullback, such as during recording of IVUS data, are illustrated in accordance with at least one embodiment of the present disclosure.

[0029] Fig.13 Illustrated is a screen display during review of an IVUS image acquired during pullback.

[0030] Fig.14 Shown are screen displays for viewing IVUS image data in accordance with at least one embodiment of the present disclosure.

[0031] Fig.15 Shown are screen displays for viewing IVUS image data in accordance with at least one embodiment of the present disclosure.

[0032] Fig.16 Shown are screen displays for viewing IVUS image data in accordance with at least one embodiment of the present disclosure.

[0033] Fig.17 Screen displays during pullback, such as during recording of IVUS data, are illustrated in accordance with at least one embodiment of the present disclosure.

[0034] Fig.18 Illustrated are exemplary screen displays during the late stages of IVUS pullback in accordance with at least one embodiment of the present disclosure.

[0035] Fig.19 An exemplary screen display at or near the end of an IVUS pullback is illustrated in accordance with at least one embodiment of the present disclosure.

[0036] Fig. 20 is a screenshot of an IVUS access point selection screen in accordance with at least one embodiment of the present disclosure.

[0037] Fig.21 is a screenshot of a user guide screen display in accordance with at least one embodiment of the present disclosure.

[0038] Fig. 22 is a screenshot of a pull-back navigation and tag display in accordance with at least one embodiment of the present disclosure.

[0039] Fig.23 is a screenshot of a pull-back navigation and tag display in accordance with at least one embodiment of the present disclosure.

[0040] Fig.24 A flow chart of an exemplary intraluminal directional guidance method according to aspects of the present disclosure is illustrated.

[0041] Fig.25 is a schematic diagram of a processor circuit according to an embodiment of the present disclosure. DETAILED DESCRIPTION

[0042] The present disclosure generally relates to medical imaging, including imaging associated with a body cavity of a patient using an intraluminal imaging device. For example, the present disclosure describes systems, devices, and methods for determining and marking the position of an intravascular imaging probe within the vascular system of a patient. 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 system associated with live IVUS images captured within the vascular system. This is particularly useful during manually controlled intravascular procedures that require detailed knowledge of the position of the imaging probe. The system, hereinafter referred to as the IVUS Pullback Virtual Venography System, helps make the correlation between IVUS frames and anatomical structures easier to understand and provides position navigation information by identifying and visually highlighting segments in arteries or blood vessels that require attention.

[0043] The devices, systems, and methods described herein may include one or more of the features described in the following: U.S. Provisional Patent Application US 62 / 750983 filed on October 26, 2018 (Attorney Docket No. 2018PF01112-44755.2000PV01), U.S. Provisional Patent Application US 62 / 751268 filed on October 26, 2018 (Attorney Docket No. 2018PF01160-44755.1997PV01), U.S. Provisional Patent Application US 62 / 751289 filed on October 26, 2018 (Attorney Docket No. 2018PF01159-44755.1998PV01), U.S. Provisional Patent Application US 62 / 751287 filed on October 26, 2018 (Attorney Docket No. 2018PF01161-44755.1997PV01), 62 / 750996 (attorney docket number 2018PF01145-44755.1999PV01), U.S. Provisional Patent Application US 62 / 751167 filed on October 26, 2018 (attorney docket number 2018PF01115-44755.2000PV01), and U.S. Provisional Application US 62 / 751185 filed on October 26, 2018 (attorney docket number 2018PF01116-44755.2001PV01), each of which is hereby incorporated by reference in its entirety as if fully set forth herein.

[0044] The devices, systems, and methods described herein can also include one or more of the features described in U.S. Provisional Application No. 62 / 642,847 filed on March 14, 2018 (attorney docket number 2017PF02103) (and a non-provisional application filed therefrom on March 12, 2019, U.S. serial number US 16 / 351,175), U.S. Provisional Application No. 62 / 712,009 filed on July 30, 2018 (attorney docket number 2017PF02296), U.S. Provisional Application No. 62 / 711,927 filed on July 30, 2018 (attorney docket number 2017PF02101), and U.S. Provisional Application No. 62 / 643,366 filed on March 15, 2018 (attorney docket number 2017PF02365) (and a non-provisional application filed therefrom on March 15, 2019, U.S. serial number US 16 / 354,970), each of which is hereby incorporated by reference in its entirety as if fully set forth herein.

[0045] The present disclosure substantially assists clinicians in directional, navigating and guiding intravascular imaging probes or intraluminal imaging probes in a patient's blood vessels or lumens by providing a venogram-type roadmap during an intraluminal medical imaging procedure. The venogram-type roadmap may include a stylized, statistically representative human anatomical structure, as well as a directional indicator, an automatic measurement tool, a step-by-step navigation or operation instruction, and a co-registered vascular map showing the position of the probe within the patient's anatomical structure. The IVUS pullback virtual venography system disclosed herein implemented on a medical imaging console (e.g., an intraluminal imaging console) that communicates with a medical imaging sensor (e.g., an intraluminal ultrasound sensor) saves time and improves the positional certainty of the captured images. The improved imaging workflow converts raw imaging data into annotated roadmaps, anatomical measurements, and step-by-step instructions for clinicians to perform a given procedure. This occurs without the usual routine of manually interpreting clinical images to determine their anatomical position and orientation. This unconventional approach improves the functionality of medical imaging consoles and sensors by allowing more efficient workflows and more useful clinical outputs. For example, various aspects of co-registration are described in U.S. Pat. No. 7,930,014 and U.S. Pat. No. 8,298,147, which are hereby incorporated by reference in their entirety. The stylized graphic can include a graphic, chart, drawing, or diagram that is stored in and retrieved from memory (e.g., common to all patients, or representative of all patients), or is generated from data obtained from one or more IVUS images and is distinct from an actual image obtained by an imaging device (e.g., X-ray or IVUS).

[0046] The IVUS pullback virtual venography system can be implemented as a set of logical branches and mathematical operations, the output of which is visible on a display and is operated by a control process executed on a processor, which accepts user input from a keyboard, mouse, or touch screen interface and communicates with one or more medical imaging sensors (e.g., an intraluminal ultrasound sensor). In this aspect, the control process performs certain specific operations in response to different inputs or selections made by the user at the beginning of the imaging process, and may also respond to inputs made by the user during the procedure. Certain structures, functions, and operations of processors, displays, sensors, and user input systems are known in the art, and other structures, functions, and operations are described herein to enable specific implementation of novel features or aspects of the present disclosure.

[0047] Various types of intraluminal imaging systems are used to diagnose and treat disease. For example, intravascular ultrasound (IVUS) imaging is used as a diagnostic tool for visualizing blood vessels within a patient's body. This can assist in evaluating diseased or compressed blood vessels, such as arteries or veins, within the human body to determine the need for treatment, optimize treatment, and / or evaluate the effectiveness of treatment (e.g., by imaging the blood vessels before and after treatment).

[0048] In some cases, intraluminal imaging is performed using an IVUS device that includes one or more ultrasonic transducers. The IVUS device can be delivered into a blood vessel and guided to the area to be imaged. The transducer emits ultrasonic energy and receives ultrasonic echoes reflected from the blood vessel. The ultrasonic echoes are processed to create an image of the blood vessel of interest. The image of the blood vessel of interest can include one or more lesions or blockages in the blood vessel and / or areas that are narrowed by compression. Stents can be placed in the blood vessel to treat these blockages or stenosis, and intraluminal imaging can be performed to view the placement of the stent in the blood vessel. Other types of treatments include thrombectomy, ablation, angioplasty, medications, etc.

[0049] Understanding which artery or vessel segment a particular IVUS frame belongs to can be challenging and time-consuming, especially because physicians only see cross-sectional IVUS images and reconstructed longitudinal views (image longitudinal display or ILD) on a dedicated IVUS screen, without any anatomical references (bone landmarks) that they can reference. In order to understand the position of the IVUS probe relative to the patient's anatomical structure, physicians currently view fluoroscopic images during pullback, which are located on another screen. In addition, during peripheral vascular intervention, the anatomical reference for the boundary of the segment is the confluence and branching with other blood vessels, which physicians and other users identify on IVUS when pulling back and in LIVE mode, and they must remember mentally. Clinicians can also call out regions of interest to their less skilled assistants. The IVUS pullback virtual venography system overcomes the insufficiency of reference landmarks and displays the relative position of the IVUS frame, making the IVUS image easier to interpret. The IVUS pullback virtual venography system depicts this information with a simple, stylized anatomical visualization, which helps in image interpretation after the completion of the pullback, and provides contextual visualization of bookmarked frames. The IVUS Pullback Virtual Venography System reduces staff dependency for vascular surgeons.After completion of the pullback, IVUS measurements are automatically plotted on the IVUS Pullback Virtual Venography System in an easy to interpret format.

[0050] During the pullback, the frames of the confluence, health frames and most obstructions are currently usually performed by non-sterile staff. In common cases, these personnel add bookmarks on the IVUS screen in response to the physician's order. However, there is usually a time delay between these two actions, resulting in offset marked frames. In addition, it may not be possible to mark when bookmarking, so the task of reporting (after this situation) is more tedious and cumbersome, because bookmarks are not distinguished on the ILD view. The IVUS pullback virtual venography system simplifies the communication between vascular surgeons and their staff, because frames and segments are automatically clearly marked. The IVUS pullback virtual venography system saves a lot of time for non-sterile operators, makes medical records more complete and makes it easier to make case instructions for vascular surgeons. The IVUS pullback virtual venography system automatically marks the key frames of interest (for example, external iliac vein (EIV), EIV Ref, EIV Pre Target, etc.) by capturing its vascular segments.

[0051] The IVUS pull-back virtual venography system includes a graphical representation of the venogram, with position navigation aids, vessel and artery segmentation, highlighted segments of interest or attention, IVUS frame position highlighting, and automatic marking and prompting.

[0052] These descriptions are provided for exemplary purposes only and should not be considered to limit the scope of the IVUS pullback virtual venography system. Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter.

[0053] In order to promote the understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the accompanying drawings, and specific language will be used to describe them. However, it should be understood that it is not intended to limit the scope of the present disclosure. As the technical personnel in the field of the present disclosure usually think of, any changes and further modifications to the described equipment, systems and methods, as well as any further application of the principles of the present disclosure, are fully considered and included in the content of the present disclosure. Specifically, it is fully contemplated that the features, components and / or steps described in relation to an embodiment can be combined with the features, components and / or steps described in relation to other embodiments of the present disclosure. However, for the sake of brevity, many iterations of these combinations will not be described separately.

[0054] Figure 1 is a schematic illustration of an intraluminal imaging system incorporating an IVUS pullback virtual venography system in accordance with various aspects of the present disclosure. In some embodiments, the intraluminal imaging system 100 can be an intravascular ultrasound (IVUS) imaging system. The intraluminal imaging system 100 can include 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, which can include angiography, ultrasound, X-ray, computed tomography (CT), magnetic resonance imaging (MRI), or other imaging techniques, devices, and methods. The intraluminal device 102 is sized and shaped and / or otherwise structurally arranged to be positioned within a body cavity of a patient. For example, in various embodiments, the intraluminal device 102 can be a catheter, a guidewire, a guide catheter, a pressure wire, and / or a flow wire. In some cases, the system 100 can include additional components and / or can be used without Figure 1 For example, the system 100 may omit the external imaging system 132.

[0055] The intraluminal imaging system 100 (or intravascular imaging system) can be any type of imaging system suitable for use within a lumen or vasculature of a patient. In some embodiments, the intraluminal imaging system 100 is an intraluminal ultrasound (IVUS) imaging system. In other embodiments, the intraluminal imaging system 100 may include a system configured for forward-looking intraluminal ultrasound (FL-IVUS) imaging, intraluminal photoacoustic (IVPA) imaging, intracardiac echocardiography (ICE), transesophageal echocardiography (TEE), and / or other suitable imaging modalities.

[0056] It should be understood that the system 100 and / or the device 102 can be configured to obtain any suitable intraluminal imaging data. In some embodiments, the device 102 can include imaging components of any suitable imaging modality, such as optical imaging, optical coherence tomography (OCT), etc. In some embodiments, the device 102 can 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, the device 102 can include imaging elements to obtain intraluminal imaging data associated with the lumen 120. The device 102 can be sized and shaped (and / or configured) for insertion into a vessel or lumen 120 of a patient.

[0057] System 100 can be deployed in the intubation laboratory with control room. Treatment system 106 can be located in the control room. Optionally, treatment system 106 can be located elsewhere, such as in the intubation laboratory itself. The intubation laboratory can include a sterile area, and its associated control room can be sterile or non-sterile, depending on the process to be performed and / or health care institutions. The intubation laboratory and control room can be used to perform any number of medical imaging processes, such as angiography, fluoroscopy, CT, IVUS, virtual histology (VH), prospective IVUS (FL-IVUS), intraluminal photoacoustic (IVPA) imaging, blood flow reserve fraction (FFR) determination, coronary blood flow reserve (CFR) determination, optical coherence tomography (OCT), computed tomography, intracardiac echocardiography (ICE), prospective ICE (FLICE), intraluminal contrast, transesophageal ultrasound, fluoroscopy and other medical imaging modalities, or a combination thereof. In some embodiments, the device 102 may be controlled from a remote location, such as a control room, so that an operator is not required to be in close proximity to the patient.

[0058] The intraluminal device 102, PIM 104, monitor 108, and external imaging system 132 can be directly or indirectly coupled to the processing system 106. These elements can be coupled to the medical processing system 106 via a wireless connection such as a standard copper link or an optical fiber link and / or via a wireless connection using the IEEE 802.11 Wi-Fi standard, an ultra-wideband (UWB) standard, wireless FireWire, wireless USB, or another high-speed wireless network standard. The processing system 106 can be communicatively coupled to one or more data networks, for example, a TCP / IP-based local area network (LAN). In other embodiments, different protocols such as a synchronous optical network (SONET) can be utilized. In some cases, the processing system 106 can be communicatively coupled to a wide area network (WAN). The processing system 106 can utilize network connectivity to access various resources. For example, the processing system 106 can communicate with a medical digital imaging and communications (DICOM) system, a picture archiving and communication system (PACS), and / or a hospital information system via a network connection.

[0059] At a high level, the ultrasound imaging intraluminal device 102 transmits ultrasound energy from a transducer array 124 included in a scanner assembly 110 mounted near the distal end of the intraluminal device 102. The ultrasound energy is reflected by tissue structures in a medium (such as a lumen 120) surrounding the scanner assembly 110, and ultrasound echo signals are received by the transducer array 124. The scanner assembly 110 generates (one or more) electrical signals representing the ultrasound echoes. The scanner assembly 110 can include one or more single ultrasound transducers and / or transducer arrays 124 of any suitable configuration, such as a planar array, a curved array, a circumferential array, an annular array, etc. For example, in some cases, the scanner assembly 110 can be a one-dimensional array or a two-dimensional array. In some cases, the scanner assembly 110 can be a rotating ultrasound device. The active area of ​​the scanner assembly 110 can include one or more transducer materials and / or one or more segments of ultrasound elements (e.g., one or more rows, one or more columns, and / or one or more orientations) that can be controlled and activated in unison or independently. The active area of ​​the scanner assembly 110 can be patterned or configured into a variety of basic or complex geometric structures. The scanner assembly 110 can be arranged in a side-view orientation (e.g., ultrasonic energy emitted perpendicular to and / or orthogonal to the longitudinal axis of the intraluminal device 102) and / or a forward-view orientation (e.g., ultrasonic energy emitted parallel to and / or along the longitudinal axis). In some cases, the scanner assembly 110 is structurally arranged to emit and / or receive ultrasonic energy at an oblique angle relative to the longitudinal axis in a proximal or distal direction. In some embodiments, the ultrasonic energy emission can be electronically manipulated by selectively triggering one or more transducer elements of the scanner assembly 110.

[0060] The ultrasonic transducer(s) of the scanner assembly 110 can be a piezoelectric micromachined ultrasonic transducer (PMUT), a capacitive micromachined ultrasonic transducer (CMUT), a single crystal, lead zirconate titanate (PZT), a PZT composite, other suitable transducer types, and / or combinations thereof. In embodiments, the ultrasonic transducer array 124 can include any suitable number of individual transducer elements or acoustic elements between 1 acoustic element and 1000 acoustic elements, including 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 ​​that are greater or less.

[0061] The PIM 104 transmits the received echo signals to a processing system 106 where an ultrasound image (including flow information) is reconstructed and displayed on a monitor 108. The console or processing system 106 can include a processor and a memory. The processing system 106 can be operable to facilitate the features of the intraluminal imaging system 100 described herein. For example, the processor can execute computer-readable instructions stored on a non-transitory tangible computer-readable medium.

[0062] The PIM 104 facilitates signal communication between the processing system 106 and the scanner assembly 110 included in the intraluminal device 102. This communication may include providing commands to the (one or more) integrated circuit controller chips within the intraluminal device 102, selecting (one or more) specific elements on the transducer array 124 for transmission and reception, providing a transmission trigger signal to the (one or more) integrated circuit controller chips to activate the transmitter circuit to generate an electrical pulse to excite the selected (one or more) transducer array elements, and / or accepting amplified echo signals received from the selected (one or more) transducer array elements via amplifiers included on the (one or more) integrated circuit controller chips. In some embodiments, the PIM 104 performs preliminary processing of the echo data before relaying the data to the processing system 106. In an example of such an embodiment, the PIM 104 performs amplification, filtering, and / or aggregation of the data. In an embodiment, the PIM 104 also provides high and low voltage DC power to support the operation of the intraluminal device 102, which includes circuits within the scanner assembly 110.

[0063] The processing system 106 receives echo data from the scanner assembly 110 by way of the PIM 104 and processes the data to reconstruct an image of tissue structures in the medium surrounding the scanner assembly 110. In general, the device 102 can be utilized within any suitable anatomical structure and / or body cavity of a patient. The processing system 106 outputs image data so that an image of a vessel or lumen 120, such as a cross-sectional IVUS image of the lumen 120, is displayed on a monitor 108. The lumen 120 can represent a structure filled with or surrounded by a fluid, and can be both natural and artificial. The lumen 120 can be within the body of a patient. The lumen 120 can be a blood vessel, such as an artery or vein of the patient's vasculature, including the cardiac vasculature, peripheral vasculature, neural vasculature, renal vasculature, and / or any other suitable lumen within the body. For example, the device 102 may be used to examine any number of anatomical locations and tissue types, including, but not limited to: organs, including the liver, heart, kidneys, gallbladder, pancreas, lungs; ducts; intestines; nervous system structures, including the brain, dural sac, spinal cord, and peripheral nerves; urinary tract; and valves within the blood, chambers of the heart or other parts and / or other systems of the body. In addition to natural structures, the device 102 may be used to examine artificial structures, such as, but not limited to: heart valves, stents, shunts, filters, and other devices.

[0064] The controller or processing system 106 may include a processing circuit having one or more processors communicating with a memory and / or other suitable tangible computer-readable storage media. The controller or processing system 106 may be 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 in a single component. For example, the system 100 can include a touch screen device, including a housing with a touch screen display and a processor. The system 100 can include any suitable input device, such as a touch-sensitive pad or a touch screen display, a keyboard / mouse, a joystick, a button, etc., for the user to select the options shown on the monitor 108. The processing system 106, the monitor 108, the input device and / or a combination thereof can be referred to as the controller of the system 100. The controller can communicate with other components of the device 102, the PIM 104, the processing system 106, the monitor 108, the input device and / or the system 100.

[0065] In some embodiments, the intraluminal device 102 includes features similar to conventional solid-state IVUS catheters, such as those available from Philips. catheters and those disclosed in U.S. Pat. No. 7,846,101 (incorporated herein by reference in its entirety). For example, the intraluminal device 102 can include a scanner assembly 110 near the distal end of the intraluminal device 102 and a transmission harness 112 extending along the longitudinal body of the intraluminal device 102. The cable or transmission harness 112 can include a plurality of conductors, including one, two, three, four, five, six, seven or more conductors.

[0066] The transmission harness 112 terminates in a PIM connector 114 at the proximal end of the intraluminal device 102. The PIM connector 114 electrically couples the transmission harness 112 to the PIM 104 and physically couples the intraluminal device 102 to the PIM 104. In an embodiment, the intraluminal device 102 also includes a guidewire outlet 116. Thus, in some cases, the intraluminal device 102 is a rapid-change catheter. The guidewire outlet 116 allows a guidewire 118 to be inserted toward the distal end in order to guide the intraluminal device 102 through the lumen 120.

[0067] Monitor 108 may be a display device, such as a computer monitor or other type of screen. Monitor 108 may be used to display selectable prompts, instructions, and visualizations of imaging data to the user. In some embodiments, monitor 108 may be used to provide a procedure-specific workflow to the user to complete an intraluminal imaging procedure. The workflow may include performing a pre-stent planning to determine the state of the lumen and potential for a stent, and a post-stent inspection to determine the state of a stent that has been positioned in the lumen. The workflow may be presented to the user as a Figure 5-7 Any display or visualization shown in .

[0068] The external imaging system 132 can be configured to obtain X-ray, radiographic, angiographic / venographic (e.g., with contrast agent), and / or fluoroscopic (e.g., without contrast agent) images of the patient's body (including the blood vessel 120). The external imaging system 132 can also be configured to obtain computed tomography images of the patient's body (including the blood vessel 120). The external imaging system 132 can include an external ultrasound probe configured to obtain ultrasound images of the patient's body (including the blood vessel 120) when located outside the body. In some embodiments, the system 100 includes other imaging modality systems (e.g., MRI) to obtain images of the patient's body (including the blood vessel 120). The processing system 106 can utilize the images of the patient's body in conjunction with the intraluminal images obtained by the intraluminal device 102.

[0069] Figure 2 Blood vessels (eg, arteries and veins) in the human body are illustrated. For example, veins of the human body are labeled. Aspects of the present disclosure can relate to peripheral vasculature, for example, veins in the torso or legs.

[0070] Blockage can occur in an artery or vein.Blockage can generally represent any blockage or other structural arrangement, which results in, for example, limiting the flow of fluid through a lumen (e.g., an artery or vein) in a manner that is harmful to the patient's health.For example, occlusion narrows the lumen, so that the cross-sectional area of ​​the lumen and / or the available space for fluid flow through the lumen are reduced.In the case where the anatomical structure is a blood vessel, occlusion may be the result of narrowing due to compression (e.g., from an external blood vessel) plaque accumulation, including but not limited to: plaque components, such as fibrous, fibrolipid (fibrous fat), necrotic core, calcification (dense calcium), blood and / or thrombus (acute, subacute, chronic, etc.) at different stages.In some cases, occlusion can be referred to as thrombus, stenosis and / or lesion.Usually, the composition of the blockage will depend on the type of anatomical structure being evaluated.The healthier part in the anatomical structure can have a uniform or symmetrical profile (e.g., a cylindrical profile with a circular cross-sectional profile).Blockage may not have a uniform or symmetrical profile.Therefore, the diseased or compressed part of the anatomical structure with blockage will have an asymmetric and / or otherwise irregular profile. The anatomical structure can have one obstruction or multiple obstructions.

[0071] The accumulation of obstruction (e.g., thrombus, deep vein thrombosis or DVT, chronic total occlusion or CTO, etc.) is a way to reduce the cross-sectional area of ​​the vein in the peripheral vascular system (e.g., trunk, abdomen, groin, leg). Other anatomical structures that contact the vein can also reduce its cross-sectional area, thereby limiting the blood flowing through it. For example, an artery or ligament in the trunk, abdomen, groin or leg can press on the vein, which changes the shape of the vein and reduces its cross-sectional area. Such a reduction in cross-sectional area due to contact with other anatomical structures can be called compression because the wall of the vein is compressed due to contact with an artery or ligament.

[0072] Figure 3 A blood vessel 300 is shown containing a thrombus 330. The thrombus occurs between the walls of the blood vessel 310 and may restrict the flow of blood 320. There are many types of thrombi, including subacute thrombi, acute thrombi, and chronic thrombi.

[0073] Figure 4A blood vessel 300 is illustrated containing a thrombus 330 and having a stent 440 expanded therein to restore flow. The stent 440 squeezes and inhibits the thrombus 330, opens the blood vessel 300, and prevents the thrombus 330 from traveling through the blood vessel 300. The stent 440 also pushes the vessel wall 310 outward, thereby reducing the flow restriction to the blood 320. Other treatment options for alleviating the blockage may include, but are not limited to, thrombectomy, ablation, angioplasty, and medication. However, in most cases, it is highly desirable to obtain accurate and timely intravascular images of the affected area, as well as accurate and detailed understanding of the location of the affected area before, during, or after treatment. Inaccurate or imprecise location information for IVUS images may, for example, bring the risk of ablating or stenting healthy tissue rather than diseased or compressed tissue during operation.

[0074] Figure 5-23 An exemplary screen display or graphical user interface (GUI) is illustrated. The screen display can be generated in the processor 106 and can be shown (e.g., displayed) on a display or monitor 108 of the system 100, such as a console, cart, bedside controller, mobile device (e.g., smart phone, tablet computer, personal digital assistant or PDA), laptop computer, desktop computer, etc. The display 108 can be a touch screen display. The display 108 can communicate with a computer or processing system 106 having processing circuitry (e.g., one or more processors and memory). The processing circuitry can generate and output display data so that the display 108 shows Figure 5-23 The computer, processing circuitry, and / or processor 106 can also communicate with a user interface on which a user provides input. The input can be a selection of an item on the screen display. In some cases, the user interface can be a touch screen display. The user interface can be a keyboard, a mouse, a controller with buttons, a joystick, etc.

[0075] Figure 5-9A screen display is illustrated that provides guidance to clinicians during IVUS pullback in the peripheral vascular system. The screen display advantageously provides additional clarity for the user to more clearly visualize various aspects of deep vein disease. The screen display performs several functions, including highlighting segments of the vascular system, marking the segments, and color coding or highlighting / distinguishing the segments and / or adjacent anatomical structures. The screen display also automatically provides reference and compression measurements (e.g., cross-sectional lumen area, diameter, etc.) within each of the segments. Segments that meet certain criteria (e.g., a difference greater than or equal to 50% between the reference and compression measurements) are differently colored, highlighted, bolded, or marked (e.g., red) to indicate segments of clinical interest or concern. In addition, the screen display also provides real-time feedback on the pullback speed to the user. The GUI can also provide image quality improvement by providing the ability to adjust contrast, gain, focus, and / or other image settings. Image quality can also be improved based on providing feedback to the user to achieve the correct pullback speed so as to obtain a sufficient amount of high-quality IVUS data. The on-screen display provides: direct mapping to anatomy, instant live values ​​(reference values, compression measurements), color coded segment highlighting, pullback speed meter (guidance).

[0076] As shown, Figure 5-9 The screen display includes a graphical representation of the peripheral vascular system (e.g., inferior vena cava, abdominal vena cava, renal veins, left and right common iliac veins, left and right common femoral veins, etc.) in which the intraluminal ultrasound device (e.g., IVUS catheter) is located. The graphical representation can be a diagram or cartoon (e.g., a virtual or non-medical image venogram) and / or an X-ray / CT / MRI image of the vascular system. For example, the graphical representation can be a roadmap image. The graphical representation can be formed from the IVUS image obtained. The graphical representation illustrates the longitudinal extent of the vascular system and can be referred to as a longitudinal display or image longitudinal display (ILD).

[0077] In some embodiments, a graphical representation of an IVUS catheter is also shown, including a flexible elongated member positioned within the vasculature and a transducer array at a distal portion of the flexible elongated member. The position of the IVUS catheter within the vasculature is shown during imaging pullback. Figure 5-9 Change. As in Figure 5 As shown in FIG, the IVUS catheter begins with a transducer array located in the inferior vena cava or the abdominal vena cava. During pullback, the transducer array is moved within the vasculature through the left iliac vein (e.g., Figure 7 ) longitudinally to the left femoral vein (e.g., Fig. 9 ).

[0078] In some embodiments, the user is required to mark key anatomical landmarks such as CIV, EIV, and CFV as the imaging catheter passes through or passes through them during the pullback recording. In other embodiments, the system is able to automatically detect these landmarks based on image analysis. In some embodiments, the accuracy of the automatic analysis is further enhanced by introducing the following steps: in the steps, the user indicates the point of entry into the system (femur, jugular vein, left / right leg) before starting the pullback. In some embodiments, as imaging proceeds, the system is also able to detect and highlight adjacent areas of interest.

[0079] Figure 5 A screen display of an exemplary cartoon roadmap or virtual venogram 500 at the beginning of a pullback procedure of an imaging catheter 510 in the inferior vena cava or abdominal vena cava 530 is shown in accordance with at least one embodiment of the present disclosure. A speed indicator 520 is provided to provide guidance regarding the pullback speed. The pullback speed affects the amount of imaging data collected at locations along the length of the vasculature and, therefore, affects the image quality of the IVUS images at those locations. Different colors, shading, text, numerical values, etc. within the speed indicator 520 can alert the user as to whether to speed up (go faster), slow down (go slower), and / or maintain speed during the pullback. For example, in Figure 5-9 A speedometer with numerical values ​​is shown in FIG. All or part of the speedometer can be colored to guide the user. For example, in Figure 5 , 6 In and 7, a colored (eg, green) highlight on the speedometer indicates to the user that the pullback speed is appropriate and should be maintained.

[0080] Also visible in this example are left and right common iliac veins (CIV) 540, left and right external iliac veins (EIV) 550, left and right common femoral veins (CFV) 560, and left and right femoral veins (F) 570. In other examples, one may replace or in addition to Figure 5 In addition to that shown in , other vasculature is also visualized.

[0081] Figure 6 A screen display of an exemplary cartoon roadmap or virtual venogram 500 during a pullback procedure of an imaging catheter 510 in the inferior vena cava in accordance with at least one embodiment of the present disclosure is shown. In this example, the virtual venogram 500 now includes a text label 634 ("IVC") adjacent to the vasculature to identify the inferior vena cava 530 as the segment of the vasculature currently occupied by the catheter 510, corresponding to the highlighted segment of the virtual venogram 500. For example, the label can be an abbreviated form or a full form of the name of the corresponding vasculature segment.

[0082] The screen display also automatically provides a statistically representative reference value 636 associated with the vasculature segment 530 and adjacent to the vasculature segment 530. The reference value can be, for example, an expected value for a healthy vessel based on the literature. The reference value can be a value for a healthy vessel for a particular patient. For example, the reference value can be a numerical value for the cross-sectional lumen area. Figure 6 The numerical values ​​shown in are merely exemplary and do not necessarily reflect values ​​associated with specific anatomical structures. In this example, the inferior vena cava or abdominal vena cava 530 has been colored, shaded and / or highlighted in the virtual venogram 500, such as in a first color (e.g., blue). The color for the IVC segment can be different from the colors associated with other vascular system segments to indicate that it is the beginning of the pullback. The color of the segment can also indicate that no compression measurement has been determined based on the IVUS data obtained, or that the compression measurement is equal to or approximately equal to the reference measurement.

[0083] Figure 7 A screen display of an exemplary virtual venogram 500 is illustrated after the transducer array 124 at the end of the catheter 510 has been moved into the left common iliac vein 540 in accordance with at least one embodiment of the present disclosure. A text label 744 ("CIV") is provided adjacent to the vasculature to identify the segment occupied by the transducer array as the left common iliac vein 540. If, as in this example, the catheter was in the patient's right leg instead of the left leg, the CIV 540 on the left half of the virtual venogram 500 would be labeled and the CIV 540 on the right half of the virtual venogram 500 would be blank.

[0084] In this example, when the transducer array 124 moves within the vascular system, a reference value 746 and a compression value 748 associated with the CIV segment 540 are automatically provided on the screen display. For example, the compression value 748 can be a numerical value of the cross-sectional lumen area for a particular patient, or a percentage (%) compression value. In this aspect, the compression value is automatically calculated based on the IVUS data obtained, and then output to a screen display adjacent to the virtual venogram 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 can be a 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 differently from the IVC segment 540. For example, when the compression value 748 is less than 50% of the reference value 746, the segment can be colored in a second color (e.g., green) to indicate that the amount of compression may be harmful to the patient. Different coloring, shading, highlighting can be used for comparison of reference value 746 and compression value 748 (e.g., different colors for greater than 50%, less than 50%, between 0% and 25%, between 25% and 50%, between 50% and 75%, between 75% and 100%).

[0085] Also visible are two position indicators 710 and 720, marking the boundaries of the CIV segment 540. As the pullback continues and the catheter 510 is withdrawn downward through the vasculature (i.e., in this example, distally or toward the patient's foot), the transducer array 124 will eventually straddle the position indicators 720, and the transducer array 124 will no longer be located in the CIV segment 540.

[0086] Figure 8 A screen display of an exemplary cartoon roadmap or virtual venogram 500 is illustrated after the transducer array 124 at the end of the catheter 510 has been moved into the left external iliac vein 550 in accordance with at least one embodiment of the present disclosure. A text label 854 ("EIV") is provided adjacent to the vasculature 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. Based on a comparison between the reference value 856 and the compression value 858, the EIV segment 550 is colored differently from the IVC segment 530 and the CIV segment 540. For example, when the compression value is equal to or greater than 50% of the reference value, the EIV segment can be colored in a third color (e.g., red) to indicate that the amount of compression may be harmful to the patient.

[0087] Figure 8 Also illustrated is a speedometer 520 indicating that the pullback speed is too high. In this aspect, a larger scale of the speedometer is colored (e.g., with Figure 5-7550 ). In this example, the speedometer 520 is colored (e.g., red) to provide real-time feedback to the user that the pullback speed should be slowed down. Position markers 710 and 720 are also visible, now marking the proximal and distal boundaries of the EIV segment 550.

[0088] Fig. 9 A screen display of an exemplary virtual venogram 500 is illustrated after the transducer array 124 at the end of the catheter 510 has been moved into the left common femoral vein 560 in accordance with at least one embodiment of the present disclosure. As the transducer array passes through the vasculature segments, the vasculature segments have been sequentially highlighted on the virtual venogram 500. A text label 964 ("CFV") is provided near the vasculature to identify the segment occupied by the transducer array 124 of the catheter 510 as the common femoral vein 560. A reference value 966 and a compression value 968 associated with the CFV segment 560 are automatically provided and / or calculated. Based on a comparison between the reference value and the compression value, the CFV segment 560 is colored differently from the IVC, CIV, and EIV segments. For example, when the compression value is greater than 50% of the reference value, the segment 560 can be colored in a fourth color (e.g., yellow) to indicate that the amount of compression or occlusion is not harmful to the patient.

[0089] Also visible are position indicators 710 and 720, which now mark the proximal and distal boundaries of the right CFV segment 560. In this example, the left femoral vein 570 is also marked ("F"), but no reference value, compression value, or color is displayed because the transducer array 515 has not yet been pulled back into the right F segment 570.

[0090] Fig.10 1 is a screenshot 1000 of an exemplary IVUS system incorporating a virtual venogram 500 in accordance with at least one embodiment of the present disclosure. The screenshot 1000 also includes a tomographic IVUS image 1010 and an IVUS image longitudinal display (ILD) 1020. In this example, the left side 1040 of the virtual venogram 500 is displayed in a very faint color (e.g., dark gray on a black background) to represent the left side of the body that is not examined. The inferior vena cava 530, the common iliac vein 540, and the common femoral vein 560 are displayed in a more visible color (e.g., a lighter gray) to show their path along the current pullback process, while the external iliac vein 550 is highlighted in an emphasis color (e.g., blue) (e.g., because this is a segment that contains a thrombus, compression, or other restriction).

[0091] Position markers 1030 are displayed within the virtual venogram 500 and ILD 1020, marking locations of interest where, for example, IVUS images can be bookmarked for later viewing. Position markers 1030a and 1030b are located in the right common iliac vein 540, while 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.

[0092] 11-12 illustrate screen displays that provide guidance to the user during and after IVUS pullback in the peripheral vasculature. The screen displays provide: automatic labeling based on anatomical landmark information (e.g., arterial branches), automatic labeling based on image analysis, bookmark thumbnails on the side, roadmap views (e.g., virtual venograms or actual venograms, the latter of which can be co-registered with tomographic image data), segment mapping, longitudinal and compression indicators, automatic labeling on all relevant components, user-selected access points, image adjustments, and a pullback speed indicator.

[0093] Fig.11A A screen display 1100 of a virtual venogram at the beginning of a pullback procedure in accordance with at least one embodiment of the present disclosure is illustrated. As indicated by the start indicator 1110, the user indicates where on the anatomy he or she is to begin the pullback on the graphical view of the vasculature displayed in the virtual venogram 500. This information is used as input to the IVUS pullback virtual venogram system to assist in automatically identifying the different vein segments 530, 540, 550, 560, and 570 as the IVUS transducer array 124 traverses the different vein segments.

[0094] Fig. 11B A screen display 1100 of a live view during a pullback procedure in accordance with at least one embodiment of the present disclosure is illustrated. A virtual venogram 500, acting as a roadmap in the live view 1100, automatically shows where the transducer array 124 is located within the body. In some embodiments, a co-registered X-ray, CAT scan, or fluoroscopic image may be used as a roadmap instead of or in addition to the virtual venogram 500. The screen display 1100 also includes a live tomographic IVUS image 1010. Additionally, the screen display 1100 includes image setting controls 1120 (e.g., gain, field of view, etc.).

[0095] Fig.12A screen display 1100 is illustrated during a pullback, for example, during recording of IVUS data, according to at least one embodiment of the present disclosure. A current frame indicator 1215 shows where the transducer array 124 of the catheter 510 is currently located on a cartoon roadmap or virtual venogram 500 of the vasculature. Label presets 1220 (e.g., vasculature segment abbreviations such as CIV, EIV, CFV, etc.) are also provided. IVUS frames are automatically labeled based on image analysis. In this example, the current position of the transducer array has been identified as the external iliac vein 550, and therefore, the EIV label preset 1220 is highlighted or illuminated. A pullback speed indicator 1230 provides guidance to a clinician or other user for a steady pullback speed. The pullback speed indicator 1230 can be a series of blocks filled based on speed (e.g., more blocks indicate faster speeds, while fewer blocks indicate slower speeds). The tomographic IVUS image 1010 shows the current frame and can generate automatic labels 1240 using image analysis with label presets described with respect to the current frame indicator 1215, for example, by vascular system segment abbreviations. When the user presses the bookmark option and / or the label preset option, a bookmark thumbnail 1250 appears. Also included is a direction indicator 1260, which, for example, shows the orientation or direction of movement of the transducer array. Anterior (A), posterior (P), middle (M), lateral (L), and / or other suitable direction labels can be used. The direction indicator can include a compass arrow that moves based on the direction of movement. Anatomical structures of interest 1270 (e.g., thrombus) within the IVUS image 1010 can be colored, shaded, and / or highlighted.

[0096] Fig.13The screen display during the viewing of the IVUS image obtained during the pullback is illustrated. The roadmap, longitudinal image or virtual venogram 500 of the vascular system shows all bookmarked frames and labels 1310 (e.g., vascular system segment abbreviations, target frames, reference frames, frames representing diseased or compressed vascular systems, frames representing vascular systems requiring treatment, frames representing healthy vascular systems, etc.). The processing system 106 performs automatic image analysis on the obtained IVUS image data and calculates one or more metrics (e.g., cross-sectional luminal area, diameter, compression, plaque burden, etc.). A graphical representation 1320 of the automatically calculated metric is shown on the roadmap image of the vascular system, for example, adjacent to the vascular system. For example, the graphical representation can be a bar (such as in a bar graph) or a histogram representing values ​​corresponding to adjacent portions of the vascular system. In some embodiments, two or more metrics can be displayed (e.g., in different colors). An alternative view 1330 of a graphical representation of one or more metrics is also shown. For example, the graphical representation extends along the screen display along the length direction, rather than adjacent to the vascular system in the roadmap image. Any suitable graphical representation, such as a line graph, a bar graph, a symbol, can be used to represent the metric 1320 on the roadmap image or an alternative view of the metric 1330. The tomographic IVUS image 1010 can be automatically assigned a label 1240 using image analysis with label presets (e.g., vascular segment name, reference frame, target frame, etc.). The tomographic IVUS image frame 1010 can also include a visual representation 1340 of one or more calculated metrics for the image frame (e.g., a numerical value of the cross-sectional luminal area, diameter). A bookmark video thumbnail 1250 is set on the screen display 1100, for example, adjacent to the tomographic IVUS image 1010. The user can click on the thumbnail 1250 to play the corresponding video with multiple IVUS image frames 1010. The user can select a representative IVUS image frame 1010 from the video clip as a thumbnail. The thumbnails include labels (eg, vasculature segment names).

[0097] Figure 14-16 Illustrated is a screen display that provides a user with a review of IVUS image data acquired during a pullback in the peripheral vasculature. The screen display provides: automatic showing of relevant metrics, automatic detection of other elements when needed, and vertical ILD.

[0098] Fig.14A screen display 1400 for viewing IVUS image data according to at least one embodiment of the present disclosure is shown. 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. Once the pullback is completed, the processing system 106 will automatically calculate using image analysis and display the percentage of compression 1430 in the vascular system segment. Image analysis is also used to calculate and display the length of the lesion 1440. Other metrics 1450 are also automatically calculated and displayed, such as cross-sectional luminal area and / or diameter corresponding to the two frames. In some cases, an average is calculated and displayed. On the right side of the screen display, a co-registered venogram or virtual venogram 500 is shown, which shows the vascular system segment containing the displayed IVUS image frames 1410 and 1420. Markers 1460 and 1470 are provided on the venogram 500 to show the location of the reference and lesion IVUS image frames 1410 and 1420. The right side of the screen display also includes a vertical ILD 1020 of the vascular system segment. It should be understood that in other examples or embodiments, the vertical ILD 1020 can be located elsewhere on the screen display 1400. The vertical ILD 1020 can be composed of the IVUS image frames 1010 obtained during the pullback. Labels (e.g., abbreviations of vascular system segments, such as CIV) are also shown. Marks are also provided on the vertical ILD to show the positions of reference and lesion IVUS image frames.

[0099] Fig.15 A screen display 1400 for viewing IVUS image data is shown in accordance with at least one embodiment of the present disclosure. The user can click on Fig.14 For example, the tomographic IVUS image frame 1410 or 1420 from Fig.14 The lesion frame 1420 is Fig.15 1420 is shown as enlarged. The user can edit the measurements on the enlarged IVUS image frame (e.g., by selecting the lumen boundary using points around the lumen or drawing a line around the lumen, the orientation of the diameter line). Direction labels 1510 (e.g., A, P, M, L) are provided around the IVUS image 1420. A marker 1470 showing the location of the selected frame 1420 is provided in the venogram 500, and a vertical ILD 1020 is provided on the right side of the screen display.

[0100] Fig.16A screen display 1400 for viewing IVUS image data in accordance with at least one embodiment of the present disclosure is shown. A user can select a help option 1610 that causes the processing system 106 to automatically segment and / or mark elements in a tomographic IVUS image 1420. For example, the automatic segmentation identifies and marks the lumen boundary (inferior vena cava or IVC) and shadow 1630 of a vasculature segment 1620 in the tomographic image 1420.

[0101] Figure 17-19 Illustrated is a screen display that provides guidance to the user during IVUS pullback in the peripheral vasculature. The screen display provides: a speed indicator for the pullback, a speedometer, a map of the vasculature established during the pullback (e.g., the map fills in as you proceed), a direction label (e.g., forward), and / or a display of arrows. Typically, the map or image of the vasculature can be a 2D or 3D graphical representation.

[0102] Fig.17A screen display 1700 is illustrated during a pullback, for example, during recording of IVUS data, in accordance with at least one embodiment of the present disclosure. On the left side of the screen display, a roadmap image, a co-registered external image, or a virtual venogram 500 of the vascular system is shown. Portions 1710 of the vascular system 1720 from which IVUS data has been collected are highlighted, colored, and / or shaded. For example, vessel boundaries in the region 1710 where the pullback has occurred are thickened, while other regions of the vessel 1720 are shown lighter. Solid thick lines 1710 can be used for vessel boundaries, while dashed thick lines 1124 can be used when crossing branch vessels. As the pullback progresses, more and more vessels 1720 are visually emphasized 1710. In this aspect, a map 500 of the vascular system 1720 is established during the pullback. On the roadmap image 500, the front (ANT) part 1730 and the back (POST) part 1740 of the vascular system are marked, wherein, as the transducer array 124 moves longitudinally from the front part 1730 to the back part 1740, a pullback occurs. Along the button of the display, a horizontal ILD 1020 is shown. It should be understood that in other examples or embodiments, the horizontal ILD 1020 can be located elsewhere within the screen display 1700. The ILD 1020 is formed by IVUS data during the pullback. As shown, the ILD 1020 is also constructed during the pullback, and as the pullback proceeds, more and more IVUS image frames 1010 are added to the ILD 1020. On the roadmap image 500, the front (ANT) part 1730 and the back (POST) part 1740 of the vascular system 1720 are marked. A compass 1260 is provided in the middle of the screen display 1700, but it can be located elsewhere on the screen display. 1720 . The compass arrow 1260 can change direction based on the orientation or direction of movement of the transducer array within the vascular system 1720 during the pullback. The pullback speed indicator 520 is disposed at the upper right of the screen display. The pullback speed indicator 520 can display the speed of the manual pullback using a numerical value. The indicator can also include a graphical representation (e.g., a symbol) of whether the speed is too fast, too slow, or correct. For example, a check mark can indicate that the pullback speed is correct.

[0103] Fig.18 An example screen display 1700 is illustrated during a later stage of IVUS pullback in accordance with at least one embodiment of the present disclosure. As shown on the virtual venogram 500 on the left side of the screen display 1700, Fig.17In comparison, a greater length of vasculature 1720 has been highlighted (1710, 1124), indicating that IVUS data has been acquired from the greater length of vasculature 1720. Similarly, a greater length of ILD 1020 has been populated with acquired IVUS image frames 1010. When the computer or processor is uncertain about the direction in which the transducer array 124 is moving or oriented within the vasculature, or when the direction / orientation is being recalculated, the direction label (ANT) of the compass 1260 or the arrow of the compass 1260 may flash.

[0104] Fig.19 An exemplary screen display 1700 at or near the end of IVUS pullback according to at least one embodiment of the present disclosure is illustrated. As shown on the virtual venogram 500 on the left side of the screen display 1700, all or almost all lengths of the vascular system 1720 under investigation have been highlighted (1710, 1124), indicating that IVUS data 1010 have been obtained from almost complete lengths. Similarly, all or almost all lengths of the ILD 1020 have been filled with the obtained IVUS image frame 1010. The pullback speed indicator 520 in the upper right corner of the screen display 1700 shows that the pullback speed is too high. For example, a symbol (e.g., an exclamation mark) and / or a color (e.g., red) of a numerical speed value can be used to indicate to the user that the pullback speed should be slowed down.

[0105] Fig. 20 is a screenshot of an IVUS access point selection screen 2000 according to at least one embodiment of the present disclosure. By matching IVUS images with a priori data sets or knowledge sets of statistically representative luminal anatomy for different human subpopulations using machine learning algorithms or other training-based AI algorithms, the IVUS pullback virtual venography system is generally able to automatically identify different areas of the patient's circulatory system. However, when the IVUS pullback virtual venography system starts with accurate and specific information about the starting point and direction of travel of the ultrasound transducer 124 of the imaging catheter 510, the accuracy of vessel identification is improved. Therefore, in this example, the screen display 2000 includes an access point selector 2010 that allows a clinician or other user to select between femoral access and jugular vein access. The screen display 2000 also includes a target limb selector 2020 that allows a clinician or other user to select between the patient's right leg and left leg as the location of the IVUS pullback. These examples are illustrative only; other access points and target limbs or target areas are possible and may be used instead or in addition depending on the type of procedure, type of disease, and location of the anatomical features of interest.

[0106] Also visible are an exit button 2030 and a start button 2040. Other controls may also be provided including, but not limited to: a help button, a procedure type selector, a disease type selector, and an anatomy type selector.

[0107] Fig.21 21 is a screenshot of a user guidance screen display 2100 according to at least one embodiment of the present disclosure. A tomographic IVUS image 1010 and a 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 pull-back virtual venography system. These instructions 2115 reduce the training and memory burden on clinicians or other users by reducing the need to be familiar with the details of a given system.

[0108] Fig. 22 2 is a screen shot of a pull-back 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 venogram 500, a pull-back speed indicator 520, a user instruction 2210, and a mark button 2220. In this example, when the pull-back of the ultrasound transducer array 124 reaches the beginning of the common iliac vein, the user instruction 2210 is instructing the user to click the mark button 2220. In some embodiments, this selection is optional because the IVUS pull-back virtual venography system automatically identifies the beginning and end of different vascular system segments. In other embodiments, the IVUS pull-back virtual venography system allows a clinician or other user to select a mark for the beginning or end of a vascular system segment by voice, gesture, or other contactless command, thereby eliminating the need for non-sterile staff to operate a keyboard, mouse, joystick, or other non-sterile input device.

[0109] In this example, the IVUS image 1010 shows bifurcated arteries 2230 and bifurcated veins 2240. The size and location of these bifurcations may be important for image recognition algorithms to identify the beginning and end of different vasculature segments within the patient's body.

[0110] Fig.23is a screenshot of a pullback navigation and marking display 2200 in accordance with at least one embodiment of the present disclosure. A live tomographic IVUS image 1010, an image longitudinal display (ILD) 1020, a virtual venogram 500, a pullback speed indicator 520, a single line of user instructions 2210, a marking button 2220, an artery 2230 (no longer bifurcated, but now merged into a single lumen), and a bifurcated vein 2240 are visible. In this example, the common iliac vein (CIV) 540 has been marked and highlighted on the virtual venogram, indicating that this is the segment of the patient's vasculature currently occupied by the ultrasound imaging array 124. In this example, the right external iliac vein (EIV) 550 is marked in a different color (e.g., light gray) to indicate that this is the next segment that the imaging array 124 will enter. The remainder of the right leg vasculature 1720 is marked with a dashed line to show that it is not currently involved in the pullback procedure, while the left leg vasculature is grayed out (eg, displayed in a gray color close to the background color) to indicate that it will not be involved in the pullback procedure at all.

[0111] Fig.24 FIG. 24 is a flow chart of an exemplary intracavity directional guidance method 2400 according to various aspects of the present disclosure. It should be understood that the method can be used in the same manner as in Fig.13 The steps of method 2400 may be performed in a different order than shown, additional steps may be provided before, during, and after the steps, and / or some of the steps described may be replaced or eliminated in other embodiments. These steps may be provided, for example, as coded instructions in a program such as Figure 1 The processor of the processing system 106 is executed and displayed on the display in response to input by a clinician or other user, for example. Figure 1 on monitor 108.

[0112] In step 2410, the user, for example, Fig. 20 The process shown in (e.g., IVUS pullback process) begins with initializing the intraluminal directional guidance system with directional information. This information may include, for example, an entry point or access point into the body (e.g., jugular vein, radial artery, right or left femur) and the target anatomical structure or direction of movement. This information can be used by the system to select a specific algorithm, data set, or body region for image recognition.

[0113] In step 2420, the IVUS imaging system 100 captures an IVUS image. Such images may be captured discretely or continuously during a procedure (eg, a pullback procedure) and stored in a memory of the processing system 106.

[0114] In step 2430, the processor 106 performs boundary detection, image processing, image analysis, and pattern recognition on the captured IVUS image to identify anatomical landmarks (e.g., specific veins, and branching points between veins). When performing a pullback run, the algorithm detects these landmarks based on prior information about the geometry of the venous system. Such analysis and recognition can rely on conventional techniques, or can be training-based or learning-based (e.g., incorporating machine learning, deep learning, or other related artificial intelligence). In some embodiments, information from external images (when available) can be incorporated into the image recognition algorithm so that the patient's own unique anatomical structure is taken into account. In other embodiments or situations, the pattern recognition algorithm can search for analogs of a statistically representative luminal anatomical structure for a given subpopulation, or such a statistically representative luminal anatomical structure can be used to train one or more algorithms. Examples of boundary detection, image processing, image analysis, and / or pattern recognition include U.S. Pat. No. 6,200,268, issued on Mar. 13, 2001, and entitled “VASCULAR PLAQUE CHARACTERIZATION” by D. Geoffrey Vince, Barry D. Kuban, and Anuja Nair, U.S. Pat. No. 6,381,350, issued on Apr. 30, 2002, and entitled “INTRAVASCULAR ULTRASONIC ANALYSIS USING ACTIVE CONTOURMETHOD AND SYSTEM” by Jon D. Klingensmith, D. Geoffrey Vince, and Raj Shekhar, U.S. Pat. No. 6,381,350, issued on Jul. 11, 2006, and entitled “SYSTEM AND METHOD OF CHARACTERIZING VASCULAR TISSUE” by Anuja Nair, D. Geoffrey Vince, Jon D. Klingensmith, and Barry D. Kuban, 7074188, issued on February 13, 2007, inventors D. Geoffrey Vince, Anuja Nair and Jon D. Klingensmith, entitled "NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD", and US Patent No. 7175597, issued on May 8, 2007, inventors Jon D. Klingensmith, Anuja Nair, Barry D. Kuban and D.U.S. Patent No. 7,215,802, entitled “SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION” to Geoffrey Vince, U.S. Patent No. 7,359,554, issued on April 15, 2008, entitled “SYSTEM AND METHOD FOR IDENTIFYING AVASCULAR BORDER” to Jon D. Klingensmith, D. Geoffrey Vince, Anuja Nair, and Barry D. Kuban, U.S. Patent No. 7,463,759, issued on December 9, 2008, entitled “SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION” to Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince, the teachings of which are hereby incorporated herein by reference in their entirety.

[0115] In step 2440 , the processor indicates the identified anatomical landmarks or other results of the image analysis (such as boundaries, segments, etc.) to the user, for example as annotations or overlays on the live image data displayed on the monitor 108 .

[0116] In step 2450, the processor 106 is susceptible to accepting optional additional input from the user, including information for assisting the pattern recognition algorithm. For example, if the user believes that the identification display of step 2440 is incorrect, incomplete, misplaced, or otherwise requires correction, the user can optionally use a keyboard, mouse, joystick, trackball, or other user input device communicatively connected to the processing system 106 to correct the information.

[0117] In step 2460, if the user has entered such a correction during step 2550, the processing system 106 updates the information within the algorithm to reflect the correction. Optionally, the processing system 106 may also upload the correction to a central server, cloud server, or other remote site so that it can be incorporated into a new training set for the machine learning algorithm and then distributed to other users.

[0118] In step 2470, the processing system updates the virtual venogram 500 to show the current position and the previous position of the imaging probe, for example, as in Figure 5-10 , Figure 12-19 and Figure 22-23 As shown in .

[0119] In step 2480, if co-registered images are available, and if appropriate user input (e.g., Figure 6 6) selects a co-registered image, the processing system 106 displays the co-registered image on the display. Such co-registered images may include, for example, X-rays, fluoroscopy, CAT scans, external ultrasound, or other images captured by the external imaging system 132 and showing, for example, vasculature or other anatomical structures near the intravascular imaging probe 102.

[0120] In some embodiments, co-registered images, when available, may also be incorporated into the image recognition algorithm.

[0121] In step 2490, if the appropriate user input has been selected, the processing system 106 provides guidance to the clinician regarding the movement of the intravascular imaging probe control 104, which may be required to advance or retract the probe 102 to a desired location within the patient's body, or to mark the beginning or end of a given vessel segment, or to start or stop recording. Such guidance may be determined by conventional techniques (e.g., database lookup) or by learning-based techniques.

[0122] Those skilled in the art or of ordinary skill will appreciate that for some embodiments, one or more of the above steps may be eliminated or performed in a different sequence, and other steps may be added. For example, in some embodiments, the system operates in a fully autonomous mode, requiring no input from a user. In some embodiments, the image recognition and landmark recognition algorithms incorporate information from external images. In some embodiments, the system allows IVUS to be used by itself without the need for external images to provide orientation information or a clinician roadmap.

[0123] In some embodiments, as imaging proceeds, the system can also automatically detect and highlight adjacent landmarks (e.g., uninvestigated arteries or other blood vessels) or other areas of interest (e.g., constrictions in adjacent blood vessels). In general, the features described above enable the system to group and mark all IVUS frames between landmarks as specifically named segments belonging to the patient's vascular system. The system therefore automatically calculates relevant metrics for diagnosis of the segment, such as compression, highlights the area of ​​concern, and indicates the relative anatomical position of the IVUS frame. In other embodiments, the user can bookmark confluences, reference points, and healthy areas via voice commands, thereby avoiding the need for non-sterile staff to press buttons on the touch screen.

[0124] In other embodiments, the virtual venogram is a 3D reconstruction of the actual patient vascular anatomy obtained from the segmentation of a CT or MR angiography study. This data can be loaded onto the IVUS system from a hospital picture archiving and communication system (PACS), providing the advantage of taking into account the actual patient anatomy and correcting the position of the vascular segments accordingly. In other embodiments, when co-registration between the IVUS and fluoroscopic systems is enabled, the segments are also automatically marked on the fluoroscopic screen. Applications for the IVUS pullback virtual venogram system include IVUS education, treatment of peripheral vascular (PV) disease using an IVUS system, and linking to other vascular navigation and visualization systems, such as Philips' Vessel Navigator.

[0125] Fig.25 25 is a schematic diagram of a processor circuit 2550 according to an embodiment of the present disclosure. The processor circuit 2550 can be implemented in the ultrasound imaging system 100 or other devices or workstations (e.g., third-party workstations, network routers, etc.), or in a cloud processor or other remote processing unit, as needed to implement the method. As shown, the processor circuit 2550 may include a processor 2560, a memory 2564, and a communication module 2568. These elements can communicate with each other directly or indirectly, for example, via one or more buses.

[0126] The processor 2560 may include any combination of a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, or a general-purpose computing device, a reduced instruction set computing (RISC) device, an application-specific integrated circuit (ASIC), a field programmable gate array (FPGA), or other related logic devices, including mechanical and quantum computers. The processor 2560 may also include another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 2560 may also be implemented as a combination of computing devices, for example, a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in combination with a DSP core, or any other such configuration.

[0127] Memory 2564 may include cache memory (e.g., cache memory of processor 2560), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, solid-state memory devices, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In an embodiment, memory 2564 includes a non-transitory computer-readable medium. Memory 2564 may store instructions 2566. Instructions 2566 may include instructions that, when executed by processor 2560, cause processor 2560 to perform the operations described herein. Instructions 2566 may also be referred to as code. The terms "instructions" and "code" should be interpreted broadly to include any type of (one or more) computer-readable statements. For example, the terms "instructions" and "code" may refer to one or more programs, routines, subroutines, functions, processes, etc. "Instructions" and "code" may include a single computer-readable statement or many computer-readable statements.

[0128] The communication module 2568 can include any electronic circuit and / or logic circuit to facilitate direct or indirect communication of data between the processor circuit 2550 and other processors or devices. In this regard, the communication module 2568 can 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 ultrasound imaging system 100. The communication module 2568 can communicate within the processor circuit 2550 through a variety of methods or protocols. Serial communication protocols may include, but are not limited to: US SPI, I 2 C, RS-232, RS-485, CAN, Ethernet, ARINC 429, 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 may be bridged via UART, USART, or other suitable subsystems.

[0129] External communications (including but not limited to: software updates, firmware updates, preset sharing between the processor and the central server, or readings from the ultrasound device) can be accomplished using any appropriate wireless or wired communication technology, such as a cable interface such as USB, micro USB, Lightning or FireWire interface, Bluetooth, Wi-Fi, ZigBee, Li-Fi, or a cellular data connection such as 2G / GSM, 3G / UMTS, 4G / LTE / WiMax or 5G. For example, a Bluetooth low energy (BLE) radio can be used to establish a connection with a cloud service, transfer data, and receive software patches. The controller can be configured to communicate with a remote server or a local device such as a laptop, tablet computer, or handheld device, or can include a display capable of showing state variables and other information. Information can also be transmitted on a physical medium 610 such as a USB flash drive or memory stick.

[0130] There may be numerous variations on the above examples and embodiments. For example, the IVUS pullback virtual venography system may be employed in anatomical systems within the body other than those described, or may be used to image other disease types, object types, or procedure types other than those described. The techniques described herein may be applied to a variety of types of intraluminal imaging sensors, whether currently existing or developed hereinafter.

[0131] Therefore, the logical operations constituting the embodiments of the technology described herein are variously referred to as operations, steps, objects, elements, components or modules. In addition, it should be understood that these operations can be performed in any order, unless otherwise explicitly stated, or the claim language inherently requires a specific order. All directional references (such as upper, lower, inner, outer, upward, downward, left, right, side, front, rear, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, near end and far end) are only used for identification purposes, to help readers understand the claimed subject matter, and do not generate restrictions, particularly in the position, orientation or use of the IVUS pull-back virtual venography system. Unless otherwise noted, connection references (such as, attachment, coupling, connection and combination) should be broadly interpreted, and may include intermediate members between element sets and relative motion between elements. In this way, connection references do not necessarily imply that two elements are directly connected and are in a fixed relationship with each other. The term "or" should be interpreted as representing "and / or" rather than "exclusive or". Unless otherwise stated in the claims, the values ​​described should be interpreted as illustrative only, and should not be considered limiting.

[0132] The above specification, examples, and data provide a complete description of the structure and use of an exemplary embodiment of the IVUS pullback virtual venography system as defined in the claims. Although various embodiments of the claimed subject matter have been described above with a certain degree of particularity or with reference to one or more individual embodiments, a person skilled in the art may make various changes to the disclosed embodiments without departing from the spirit or scope of the claimed subject matter. Other embodiments are also contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings should be interpreted as merely illustrative of particular embodiments and not limiting. Changes in detail or structure may be made without departing from the basic elements of the subject matter as defined in the appended claims.

Claims

1. An intraluminal ultrasound imaging system, comprising: A processor circuit configured to communicate with an intraluminal ultrasound imaging catheter, wherein the processor circuit is configured to: receiving an intraluminal ultrasound image acquired by the intraluminal ultrasound imaging catheter while the intraluminal ultrasound imaging catheter is located within a body cavity of a patient, the body cavity comprising a plurality of segments; identifying a segment of the plurality of segments in which the intraluminal ultrasound imaging catheter is located when the intraluminal ultrasound image is acquired; and outputting a screen display to a display in communication with the processor circuit, the screen display comprising: a stylized representation of the body cavity including the plurality of segments; a marking button for marking the segment in the stylized graphic where the intraluminal ultrasound imaging catheter is located when the intraluminal ultrasound image is acquired, and A user instruction, which is configured to instruct a user to click the marking button; Therein, when the segment is marked it is highlighted.

2. The system according to claim 1, wherein: The screen display also includes: Markings indicating proximal and distal boundaries of one or more of the plurality of segments in the stylized graphic.

3. The system according to claim 1, wherein: The screen display also includes: Markers indicating locations of interest in the stylized graphic.

4. The system according to claim 1, wherein: The screen display also includes: One or more tags respectively identifying one or more segments in the stylized graphic.

5. The system according to claim 1, wherein: The screen display also includes: A position indicator indicates a position within the segment where the intraluminal ultrasound imaging catheter is located when the intraluminal ultrasound image is acquired in the stylized graphic.

6. The system according to claim 1, wherein: The processor circuit is configured to sequentially identify the plurality of segments in the stylized graphic as the intraluminal ultrasound imaging catheter moves through the plurality of segments.

7. The system according to claim 6, wherein: The processor circuit is configured to automatically mark sequentially identified multiple segments in the stylized graphic.

8. The system according to claim 6, wherein: The processor circuit is configured to automatically annotate the sequentially identified plurality of segments in the stylized graphic with statistically representative reference values ​​associated with corresponding segments.

9. The system according to claim 8, wherein: The processor circuit is configured to automatically annotate the sequentially identified plurality of segments in the stylized graphic with automatically measured or calculated values ​​associated with corresponding segments.

10. The system according to claim 9, wherein: The processor circuit is configured to color the sequentially identified plurality of segments based on a ratio of the automatically measured or calculated value to the statistically representative reference value.

11. The system according to claim 1, wherein: The processor circuit is configured to receive user input indicating where the intraluminal ultrasound imaging catheter was located when the intraluminal ultrasound image was acquired.

12. The system of claim 1, wherein: The processor circuit is configured to automatically determine, based on the intraluminal ultrasound image, where the intraluminal ultrasound imaging catheter was located when the intraluminal ultrasound image was acquired.

13. The system of claim 1, wherein: The screen display also includes at least one of: a longitudinal display of the body cavity, and a speed indicator associated with movement of the intraluminal ultrasound imaging catheter.

14. The system of claim 1, further comprising: The intraluminal ultrasound imaging catheter.

15. A method for intraluminal ultrasound imaging, comprising: receiving, at a processor circuit in communication with the intraluminal ultrasound imaging catheter, an intraluminal ultrasound image acquired by the intraluminal ultrasound imaging catheter while the intraluminal ultrasound imaging catheter is located within a body cavity of a patient, the body cavity comprising a plurality of segments; and identifying, using the processor circuit, a segment of the plurality of segments in which the intraluminal ultrasound imaging catheter was located when the intraluminal ultrasound image was acquired; and outputting a screen display to a display in communication with the processor circuit, the screen display comprising: a stylized representation of the body cavity including the plurality of segments; a marking button for marking the segment in the stylized graphic where the intraluminal ultrasound imaging catheter is located when the intraluminal ultrasound image is acquired, and A user instruction, which is configured to instruct a user to click the marking button; Therein, when the segment is marked it is highlighted.

16. An intravascular ultrasound imaging system for peripheral vascular system, the system comprising: an intravascular ultrasound imaging catheter configured to obtain an intravascular ultrasound image when the intravascular ultrasound imaging catheter is located within a peripheral blood vessel of a patient, the peripheral blood vessel comprising a plurality of segments; A processor circuit configured to communicate with the intravascular ultrasound imaging catheter, wherein the processor circuit is configured to: receiving the intravascular ultrasound image obtained by the intravascular ultrasound imaging catheter; identifying a segment of the plurality of segments in which the intravascular ultrasound imaging catheter is located when the intravascular ultrasound image is acquired; and outputting a screen display to a display in communication with the processor circuit, the screen display comprising: a stylized graphic of the peripheral blood vessel including the plurality of segments; a marking button for marking the segment in the stylized graphic where the intravascular ultrasound imaging catheter is located when the intravascular ultrasound image is acquired, and A user instruction, which is configured to instruct a user to click the marking button; Therein, when the segment is marked it is highlighted.

Images