Velocity determination for intraluminal ultrasound imaging and related devices, systems and methods - Patents.com

Abstract

To provide a speed indicator for simplifying acquisition and display of an ultrasonic image in a peripheral blood vessel during a pull-back procedure.SOLUTION: Disclosed is an intraluminal ultrasound imaging system including a processor circuit in communication with an intraluminal ultrasound imaging catheter, and a processor circuit is configured to receive a plurality of intraluminal ultrasound images obtained by the imaging catheter while the imaging catheter is moved through a body lumen of a patient. The processor circuit is further configured to determine a longitudinal translation speed of the intraluminal ultrasound imaging catheter on the basis of the plurality of images and a known time interval between images, and to display a speed indicator based on the longitudinal translation speed.SELECTED DRAWING: None

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 62 / 751,185, filed October 26, 2018, the entirety of which is incorporated herein by reference.

[0002]

[0002] The subject matter described herein relates to a system for medical imaging. In particular, the disclosed system provides a velocity indicator to facilitate the acquisition and display of peripheral intravascular ultrasound or IVUS images during a pullback procedure. The system is particularly useful for, but not limited to, the diagnosis and treatment of vascular disease. [Background technology]

[0003]

[0003] Peripheral vascular procedures, such as angioplasty and stenting in peripheral veins (inferior vena cava - IVC, iliac, femoral veins), IVC filter retrieval, EVAR and FEVAR (and similar for abdominal features) atherectomy and thrombectomy, are procedures for which IVUS is used. Different diseases or medical procedures result in physical features with different sizes, structures, densities, water contents, and accessibility to imaging sensors. For example, deep vein thrombosis (DVT) results in clumps of blood cells, while post-thrombotic syndrome (PTS) results in webbing or other residual structural effects in the vessel that have a similar composition to the vessel wall itself and are therefore difficult to distinguish from the vessel wall. A stent is a dense (e.g., metallic) object that is placed in a vessel or lumen to hold the vessel or lumen open to a particular diameter. Compression occurs when an anatomical structure outside the vessel or lumen strikes the vessel or lumen and constricts it.

[0004]

[0004] In some cases, intraluminal imaging is performed using an IVUS device that includes one or more ultrasound transducers. The IVUS device is passed through a vessel and guided to the area to be imaged. The transducers emit ultrasound energy and receive ultrasound echoes reflected from the vessel. The ultrasound echoes are processed to create an image of the vessel of interest. The image of the vessel of interest includes one or more lesions or blockages in the vessel. Stents are placed in the vessel to treat these blockages, and intraluminal imaging is performed to view the placement of the stent within the vessel. Other types of procedures include thrombectomy, ablation, angioplasty, drugs, etc.

[0005]

[0005] During a typical intraluminal imaging procedure (e.g., IVUS pullback), an intraluminal imaging probe (e.g., an IVUS catheter for peripheral vascular intervention, such as Philips Volcano: PV0.014, PV0.018, PV0.035) is manually pulled or pushed by a clinician. The catheter can be attached to a pullback device or sled, which moves the catheter at a predefined speed. However, many physicians do not like pullback devices because it requires an extra step of having to attach the catheter, and therefore many physicians find it easier to move the catheter manually. In particular, phased array devices do not need to be connected to a pullback device at all (and therefore physicians still prefer to move the catheter manually), whereas rotational IVUS devices need to be connected to a pullback device, which also rotates the drive cable for imaging. Thus, for many applications, the stability of the pullback speed depends on the physician's experience with the system, and care must be taken to move the probe at a speed (i.e., longitudinal translation speed) consistent with high-resolution, high-definition, low-distortion, low-noise images. A pullback speed that is too fast or too slow can degrade or distort image quality, and even short pauses or direction reversals can result in confusing data. Thus, less skilled users have difficulty capturing consistent, high-quality images.

[0006]

[0006] The information contained in this Background Technology section of the specification, including the references cited in the specification and their descriptions or discussions, is included for technical reference only and should not be considered subject matter by which the scope of the present disclosure is limited. Summary of the Invention

[0007]

[0007] A system is disclosed for calculating, displaying, and managing the speed of an intravascular imaging probe during IVUS pullback or other intraluminal procedures that require a consistent probe travel speed. For example, the present disclosure describes systems, devices, and methods for determining the travel speed of an intravascular probe during an IVUS intravascular procedure. In accordance with at least one embodiment of the present disclosure, a system is provided for determining a pullback speed based on the content of the IVUS image itself and displaying the speed as navigational information to the clinician for a desired range of speeds. This is particularly useful during manually controlled intravascular procedures where a consistent probe speed (e.g., pullback speed) within a range of interest is desired. Determining the pullback speed using the IVUS image itself is different from determining the speed by tracking the position of the catheter in an externally captured image (e.g., fluoroscopic image), and often requires fewer steps and less equipment. The system is hereinafter referred to as a pullback speed management system.

[0008]

[0008] The pullback speed management system disclosed herein is particularly useful for, but not limited to, intraluminal ultrasound imaging procedures. The pullback speed management system includes an intraluminal ultrasound imaging system, the intraluminal ultrasound imaging system comprising a processor circuit configured for communication with an intraluminal ultrasound imaging catheter, the processor circuit configured to receive a plurality of intraluminal ultrasound images acquired by the intraluminal ultrasound imaging catheter while the intraluminal ultrasound imaging catheter is moved through a patient's body lumen, determine a longitudinal translational velocity of the intraluminal ultrasound imaging catheter based on the plurality of intraluminal ultrasound images and a known time interval between each of the plurality of intraluminal ultrasound images, and output a screen display including a velocity indicator based on the longitudinal translational velocity on a display in communication with the processor circuit. Other embodiments of this aspect include corresponding computer systems, devices, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method. One or more computer systems may be configured to perform particular operations or actions by installing on the system software, firmware, hardware, or a combination thereof that causes the system to perform actions during operation. One or more computer programs may be configured to perform particular operations or actions by containing instructions that, when executed by a data processing device, cause the device to perform actions.

[0009]

[0009] Implementations include one or more of the following features: A system in which the processor circuitry is configured to update a longitudinal translation velocity based on additional intraluminal ultrasound images acquired while the intraluminal ultrasound imaging catheter is moved through the body lumen, and dynamically modify a velocity indicator in a screen display such that the velocity indicator indicates a longitudinal translation velocity based on the additional intraluminal ultrasound image. A system in which the processor circuitry is further configured to output an intraluminal ultrasound image of the plurality of intraluminal ultrasound images via the screen display, the intraluminal ultrasound image being proximate to the velocity indicator. A system in which determining the longitudinal translation velocity includes identifying an anatomical feature or landmark in one or more of the plurality of intraluminal ultrasound images, and determining a change in the anatomical feature or landmark across the one or more of the plurality of intraluminal ultrasound images. A system in which the processor circuitry is configured to determine the longitudinal translation velocity without tracking a position of the intraluminal ultrasound imaging catheter in the extraluminal images. A system in which the velocity indicator includes a shape representing a range of longitudinal translation velocities and a marker located within the shape representing the determined longitudinal translation velocity. A system in which the velocity indicator includes a region of the shape identifying an ideal range for the longitudinal translation velocity, the region extending from a first portion representing a minimum ideal translation velocity to an opposing second portion representing a maximum ideal translation velocity. A system in which the processor circuit is configured to determine at least one of a length estimate of the body lumen based on the longitudinal translation velocity or a volume estimate of the body lumen based on the longitudinal translation velocity and an area of ​​the body lumen in a plurality of intraluminal ultrasound images, and output at least one of the length estimate or the volume estimate via a screen display. A system in which the screen display further includes a stylized view of the body lumen. A system in which the screen display further includes a position of the intraluminal ultrasound imaging catheter within the stylized view.A system in which the screen display further includes a trajectory indicating past positions of the intraluminal ultrasound imaging catheter.A system in which the trajectory is color coded in the screen display to indicate past longitudinal translation velocities of the intraluminal ultrasound imaging catheter.A system further comprising an intraluminal ultrasound imaging catheter.Implementations of the described techniques include hardware, methods or processes, or computer software on a computer accessible medium.

[0010]

[0010] One general aspect includes a method for intraluminal ultrasound imaging, the method including the steps of receiving, in a processor circuit in communication with the intraluminal ultrasound imaging catheter, a plurality of intraluminal ultrasound images acquired by the intraluminal ultrasound imaging catheter while the intraluminal ultrasound imaging catheter is moved through a body lumen of a patient, determining, in the processor circuit, a longitudinal translation velocity of the intraluminal ultrasound imaging catheter based on the plurality of intraluminal ultrasound images and a known time interval between each of the plurality of intraluminal ultrasound images, and outputting, on a display in communication with the processor circuit, a screen display including a velocity indicator based on the longitudinal translation velocity. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0011]

[0011] One general aspect includes an intravascular ultrasound imaging system for use in the peripheral vasculature, the intravascular ultrasound imaging system comprising: an intravascular ultrasound imaging catheter configured to acquire a plurality of intravascular ultrasound images while the intravascular ultrasound imaging catheter is moved through a peripheral blood vessel of a patient; and a processor circuit configured for communication with the intravascular ultrasound imaging catheter, the processor circuit configured to receive the plurality of intravascular ultrasound images acquired by the intravascular ultrasound imaging catheter, determine a longitudinal translation velocity of the intravascular ultrasound imaging catheter through the peripheral blood vessel based on the plurality of intravascular ultrasound images and a known time interval between each of the plurality of intravascular ultrasound images, and output, on a display in communication with the processor circuit, a screen display including a velocity indicator based on the longitudinal translation velocity. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the method.

[0012]

[0012] This Summary of the Invention is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary of the Invention is not intended to identify key or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive presentation of the features, details, utilities, and advantages of the pullback speed management system, as defined in the claims, is provided in the following specification of various embodiments of the present disclosure and illustrated in the accompanying drawings.

[0013]

[0013] Exemplary embodiments of the present disclosure are described with reference to the accompanying drawings. [Brief description of the drawings]

[0014] [Figure 1]

[0014] FIG. 1 is a schematic diagram of an intraluminal imaging system according to an aspect of the present disclosure. [Diagram 2]

[0015] 1 illustrates blood vessels (e.g., arteries and veins) in the human body. [Diagram 3]

[0016] FIG. 1 illustrates a blood vessel containing a compression. [Figure 4]

[0017] FIG. 1 shows a blood vessel containing a compression and with a stent expanded therein to restore flow. [Diagram 5]

[0018] FIG. 13 illustrates an exemplary cartoon roadmap or virtual venogram screen display at the start of an imaging catheter pullback procedure in the inferior vena cava or abdominal vena cava, in accordance with at least one embodiment of the present disclosure. [Figure 6]

[0019] FIG. 13 illustrates an exemplary cartoon roadmap or virtual venogram screen display during an imaging catheter pullback procedure in the inferior vena cava, in accordance with at least one embodiment of the present disclosure. [Figure 7]

[0020] FIG. 13 illustrates a screen display of an exemplary virtual venogram after the transducer array at the end of the catheter has been moved to the right common iliac vein, in accordance with at least one embodiment of the present disclosure. [Figure 8]

[0021] FIG. 13 illustrates an exemplary cartoon roadmap or virtual venogram screen display after the transducer array at the end of the catheter has been moved to the right external iliac vein, in accordance with at least one embodiment of the present disclosure. [Figure 9]

[0022] FIG. 13 illustrates a screen display of an exemplary virtual venogram after the transducer array at the end of the catheter has been moved to the right common femoral vein, in accordance with at least one embodiment of the present disclosure. [Figure 10]

[0023] 4 is a flow chart illustrating the method followed by the pullback speed management system. [Figure 11A]

[0024] FIG. 13 illustrates a screen display of a virtual venogram at the start of a pullback procedure, in accordance with at least one embodiment of the present disclosure. [Figure 11B]

[0025] FIG. 13 illustrates a screen display of a live view during a pullback procedure, in accordance with at least one embodiment of the present disclosure. [Figure 12]

[0026] FIG. 13 illustrates a screen display during pullback, e.g., during recording of IVUS data, in accordance with at least one embodiment of the present disclosure. [Figure 13]

[0027] 1A-1C show screen displays associated with navigating an IVUS imaging catheter to a suggested location (eg, compression or blockage) within the vasculature. [Figure 14]

[0028] FIG. 13 shows the screen display after the IVUS imaging catheter has been moved to the indicated compression within the vasculature. [Figure 15]

[0029] FIG. 13 illustrates a screen display where the auto-border toggle has been turned on by a user. [Figure 16a]

[0030] 1 is an example of a rate indicator that provides feedback to a user about the pullback rate of an IVUS catheter. [Figure 16b] 1 is an example of a rate indicator that provides feedback to a user about the pullback rate of an IVUS catheter. [Figure 16c] 1 is an example of a rate indicator that provides feedback to a user about the pullback rate of an IVUS catheter. [Figure 17]

[0031] FIG. 13 illustrates a screen display during pullback, e.g., during recording of IVUS data, in accordance with at least one embodiment of the present disclosure. [Figure 18]

[0032] 11A-11C illustrate example screen displays during a later stage of IVUS pullback, in accordance with at least one embodiment of the present disclosure. [Figure 19]

[0033] 13A-13C illustrate example screen displays at or near the end of an IVUS pullback, in accordance with at least one embodiment of the present disclosure. [Figure 20a]

[0034] 1 is a cross-sectional intraluminal image of a tube with a tube wall. [Figure 20b]

[0035] FIG. 20b is a tomographic endoluminal image of a vessel with the vessel wall further along in the pullback than the image in FIG. 20a. [Figure 20c]

[0036] FIG. 20b is a tomographic endoluminal image of a vessel with the vessel wall further along in the pullback than the image in FIG. 20b. [Figure 21a]

[0037] 1 is a cross-sectional intraluminal image of a tube with a tube wall. [Figure 21b]

[0038] FIG. 20b is a tomographic endoluminal image of a vessel with the vessel wall further along in the pullback than the image in FIG. 20a. [Figure 22]

[0039] 2 is a schematic diagram of a processor circuit according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015]

[0040] The present disclosure generally relates to medical imaging, including imaging associated with a patient's body lumen using an intraluminal imaging device. For example, the present disclosure describes systems, devices, and methods for determining the travel speed of an intravascular probe during an IVUS pullback procedure or other intravascular procedure. In accordance with at least one embodiment of the present disclosure, a system is provided for determining a pullback speed based on the IVUS image itself and displaying the speed as navigational information to a clinician for a desired range of speeds. This is particularly useful during manually controlled intravascular procedures where a consistent probe speed (e.g., pullback speed) within a range of interest is desired. Determining the pullback speed using the IVUS image itself differs from determining the speed by tracking the position of the catheter in an extraluminal image (e.g., fluoroscopic image), and often requires fewer steps and less equipment. The system is hereinafter referred to as a pullback speed management system.

[0016]

[0041] The devices, systems, and methods described herein are incorporated by reference in their entireties as if fully set forth herein, including, but not limited to, U.S. Provisional Application No. 62 / 750,983, filed October 26, 2018 (Attorney Docket No. 2018PF01112-44755.2000PV01), U.S. Provisional Application No. 62 / 751,268, filed October 26, 2018 (Attorney Docket No. 2018PF01160-44755.1997PV01), U.S. Provisional Application No. 62 / 751,289, filed October 26, 2018 (Attorney Docket No. 2018PF0 No. 1159-44755.1998PV01), U.S. Provisional Application No. 62 / 750,996, filed on October 26, 2018 (Attorney Docket No. 2018PF01145-44755.1999PV01), U.S. Provisional Application No. 62 / 751,167, filed on October 26, 2018 (Attorney Docket No. 2018PF01115-44755.2000PV01), and U.S. Provisional Application No. 62 / 751,185, filed on October 26, 2018 (Attorney Docket No. 2018PF01116-44755.2001PV01).

[0017]

[0042] The devices, systems, and methods described herein are incorporated by reference in their entireties as if fully set forth herein, including, but not limited to, U.S. Provisional Application No. 62 / 642,847, filed March 14, 2018 (Attorney Docket No. 2017PF02103), (and the nonprovisional application filed therewith on March 12, 2019 as U.S. Patent Application No. 16 / 351175), U.S. Provisional Application No. 62 / 712,009, filed July 30, 2018 (Attorney Docket No. 2017PF02103), each of which is incorporated by reference in its entirety as if fully set forth herein. No. 2017PF02296, U.S. Provisional Application No. 62 / 711,927, filed July 30, 2018 (Attorney Docket No. 2017PF02101), and U.S. Provisional Application No. 62 / 643,366, filed March 15, 2018 (Attorney Docket No. 2017PF02365) (and the nonprovisional application filed therewith on March 15, 2019 as U.S. Patent Application No. 16 / 354970).

[0018]

[0043] The devices, systems, and methods described herein may also include one or more features described in U.S. Provisional Application No. 62 / 725,867, entitled "Intravascular Device Movement Speed ​​Guidance and associated Devices, Systems, and Methods," filed August 31, 2018 (Attorney Docket No. 2018PF00195), and U.S. Patent Application No. 16 / 542,001, filed August 15, 2019 (Attorney Docket No. 2018P00195US01), which are incorporated by reference in their entireties as if fully set forth herein.

[0019]

[0044] The present disclosure significantly aids clinicians in sensing, controlling, and maintaining the speed at which an intravascular or intraluminal imaging probe is pushed or pulled within a patient's vessel or lumen by providing visual, symbolic, alphanumeric, and sensory information regarding the speed of movement of the probe during an intraluminal medical imaging procedure. The speed information includes gauges, dials, bar indicators, numeric, and symbolic displays. Implemented on a medical imaging console (e.g., an intraluminal imaging console) in communication with a medical imaging sensor (e.g., an intraluminal ultrasound sensor), the pullback speed management system disclosed herein provides both time savings and improved quality and consistency of captured images. This improved imaging workflow transforms an irregular and inconsistent imaging process into a more controlled and repeatable process. This is done without the need for clinicians to train, for example, on a routine basis, for consistent pullback within a narrow range of acceptable pullback speeds. This non-conventional approach improves the functionality of medical imaging consoles and sensors by allowing more consistent images to be captured from existing systems that lack hardware-based speed control.

[0020]

[0045] The pullback speed management system is implemented as a set of logic branches and mathematical operations, the output of which is viewable on a display, and is operated by a control process running on a processor that accepts user input from a keyboard, mouse, or touch screen interface, and is in communication with one or more medical imaging sensors (e.g., intraluminal ultrasound sensors). In that regard, the control process performs certain operations in response to different inputs or selections made by the user at the start of an imaging procedure, and also responds to inputs made by the user during the procedure. Some of the structures, functions, and operations of the processor, display, sensor, and user input system are known in the art, while others are described herein to enable novel features or aspects of the present disclosure.

[0021]

[0046] Various types of endoluminal imaging systems are used in diagnosing and treating disease. For example, intravascular ultrasound (IVUS) imaging is used as a diagnostic tool to visualize vessels within a patient's body. This helps evaluate diseased or compressed 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., through imaging of the vessel before and after treatment).

[0022]

[0047] In some cases, intraluminal imaging is performed using an IVUS device that includes one or more ultrasound transducers. The IVUS device is passed through the vessel and guided to the area to be imaged. The transducer emits ultrasound energy and receives ultrasound echoes reflected from the vessel. The ultrasound echoes are processed to create an image of the vessel of interest. The image of the vessel of interest includes one or more lesions or blockages in the vessel. A stent is placed in the vessel to treat these blockages, and intraluminal imaging is performed to view the placement of the stent in the vessel. Other types of treatments include thrombectomy, ablation, angioplasty, drugs, etc.

[0023]

[0048] In some embodiments, the pullback speed management system includes a screen display that provides guidance to a clinician during IVUS pullback or other intravascular imaging procedures in the peripheral vasculature. The screen display provides real-time feedback of the velocity of the catheter or imaging probe within the vessel, both in absolute terms and in terms of minimum and maximum desired speeds for optimal image acquisition.

[0024]

[0049] Being able to control the speed is important to obtain adequate ultrasound image quality, allowing the user to interpret the images to suit the diagnosis (e.g., lesion length and severity) and to confirm treatment choices (e.g., balloon and stent diameter and length). Controlling the pullback speed is also essential to ensure proper functioning of image recognition and image interpretation algorithms. Excessive pullback speeds will cause some parts of the anatomy to be skipped during the imaging process, so that they never appear in the image set, thus making the data set difficult to interpret.

[0025]

[0050] Currently, for peripheral catheters, the length is estimated by the physician by looking at fluoroscopic images and considering markers on IVUS image sequences, or by relying on the physician's own experience in interpreting the location of body landmarks or other anatomical features. Keeping a stable pullback speed allows for more accurate length estimation, which is important for determining, for example, stent and balloon placement areas. Thus, the system measures the speed, rate, or speed absolutely, or against a desired or reference speed, rate, or speed, or against a range thereof. Moreover, estimating the length can also result in an automatic lumen area measurement and an automatic vessel volume measurement (area x length) derived from the length (e.g., the measured speed multiplied by the elapsed time, or the integral of the speed over time). In fact, measuring the pre- and post-treatment volumes provides the physician with an absolute measurement of the material (and mass) removed from the vessel during the procedure, and thus, in some cases, a quantitative indicator for treatment success.

[0026]

[0051] To guide the physician in reaching and maintaining a certain speed (e.g., while performing a pullback), a "speed indicator" is included on the IVUS screen, as described in the images below. This speed indicator shows the IVUS operator the actual speed (i.e., longitudinal translation speed) of the catheter in the vessel, and is automatically activated during the "record" phase of the procedure. In some embodiments, the system reports to the operator not only the speed itself, but also whether the speed is within the proper range to ensure sufficient pullback recording. The system then suggests the correct speed range by several different discernible cues. For example, a speed that is too fast / too slow can be suggested by color coding (see, e.g., Figures 8 and 9). This can involve a numerical measurement and reporting of the speed, or a variety of different ways to communicate to the user the correct range of speed to reach and maintain during the pullback (see, e.g., Figures 12, 13, and 16).

[0027]

[0052] Because of this constant speed, a rough estimate of the pullback length can be derived, which can be extremely beneficial for the physician to determine the stent length immediately after pullback and measurement review, or in some cases, to derive vessel volume (from automatic area measurement and length estimation) before and after the procedure as an indication for procedural success.

[0028]

[0053] The present disclosure applies to, for example, Philips Volcano peripheral catheters IVUS PV0.014, PV0.018, PV0.035, Pioneer Plus IVUS-guided re-entry catheters, and other products used in peripheral areas where rate control may be used and benefit treatment delivery. These include, but are not limited to, thrombectomy devices (see Genesis in AD in IGT) and atherectomy devices (e.g., Phoenix Turbo power laser atherectomy) when used in combination with IVUS.

[0029]

[0054] These descriptions are provided for illustrative purposes only and should not be considered as limiting the scope of the pullback speed management system. Certain features may be added, deleted, or modified without departing from the spirit of the claimed subject matter.

[0030]

[0055] To facilitate an understanding of the principles of the present disclosure, reference will now be made to the embodiments shown in the drawings, and specific language will be used to describe the embodiments. It will nevertheless be understood that no limitations on the scope of the present disclosure are intended. Any changes and further modifications to the described devices, systems, and methods, and any further applications of the principles of the present disclosure, as would normally occur to one skilled in the art to which the present disclosure pertains, are fully contemplated and included within the present disclosure. In particular, features, components, and / or steps described with respect to one embodiment are fully contemplated to be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. However, for the sake of brevity, multiple iterations of these combinations will not be described separately.

[0031]

[0056] FIG. 1 is a schematic diagram of an endoluminal imaging system incorporating a pullback speed management system according to aspects of the disclosure. The endoluminal imaging system 100 may be an intravascular ultrasound (IVUS) imaging system in some embodiments. The endoluminal imaging system 100 includes an endoluminal device 102, a patient interface module (PIM) 104, a console or processing system 106, a monitor 108, and an external imaging system 132, which may include angiography, ultrasound, x-ray, computed tomography (CT), magnetic resonance imaging (MRI), or other imaging techniques, equipment, and methods. The endoluminal device 102 is sized and shaped, and / or possibly structurally configured, to be positioned within a body lumen of a patient. For example, the endoluminal device 102 may be a catheter, a guidewire, a guide catheter, a pressure wire, and / or a flow wire in various embodiments. In some circumstances, the system 100 may include additional elements and / or be implemented without one or more of the elements shown in FIG. 1. For example, the system 100 omits the external imaging system 132 .

[0032]

[0057] Endoluminal imaging system 100 (or intravascular imaging system) can be any type of imaging system suitable for use in a lumen or vasculature of a patient. In some embodiments, endoluminal imaging system 100 is an intraluminal ultrasound (IVUS) imaging system. In other embodiments, endoluminal imaging system 100 includes a system configured for forward-looking intraluminal ultrasound (FL-IVUS) imaging, intraluminal photoacoustic (IVPA) imaging, intracardiac echocardiography (ICE), transesophageal echocardiography (TEE), and / or other suitable imaging modalities.

[0033]

[0058] It should be understood that the system 100 and / or device 102 may be configured to acquire any suitable endoluminal imaging data. In some embodiments, the device 102 includes imaging components of any suitable imaging modality, such as optical imaging, optical coherence tomography (OCT), etc. In some embodiments, the device 102 includes 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. In general, the device 102 may include imaging elements for acquiring endoluminal imaging data associated with the lumen 120. The device 102 is sized and shaped (and / or configured) for insertion into a patient's tube or lumen 120.

[0034]

[0059] The system 100 is deployed in a catheterization lab having a control room. The processing system 106 is in the control room. Optionally, the processing system 106 is in another location, such as the catheterization lab itself. The catheterization lab includes a sterile field, but the associated control room may or may not be sterile depending on the procedure to be performed and / or the health care facility. The catheterization lab and control room are used to perform any number of medical imaging procedures, such as angiography, fluoroscopy, CT, IVUS, virtual histology (VH), forward-looking IVUS (FL-IVUS), intraluminal photoacoustic (IVPA) imaging, fractional flow reserve (FFR) determination, coronary flow reserve (CFR) determination, optical coherence tomography (OCT), computed tomography, intracardiac echocardiography (ICE), forward-looking ICE (FLICE), intraluminal palpography, transesophageal ultrasound, fluoroscopy, and other medical imaging modalities, or combinations thereof. In some embodiments, the device 102 is controlled from a remote location, such as a control room, so that the operator does not need to be closely adjacent to the patient.

[0035]

[0060] The intraluminal device 102, the PIM 104, the monitor 108, and the external imaging system 132 are communicatively coupled directly or indirectly to the processing system 106. These elements are communicatively coupled to the medical processing system 106 via wired connections, such as standard copper or fiber optic links, and / or via wireless connections using the IEEE 802.11 Wi-Fi standard, Ultra Wideband (UWB) standard, Wireless FireWire, Wireless USB, or another high speed wireless networking standard. The processing system 106 is communicatively coupled to one or more data networks, for example, a TCP / IP based local area network (LAN). In other embodiments, a different protocol is utilized, such as Synchronous Optical Networking (SONET). In some cases, the processing system 106 is communicatively coupled to a wide area network (WAN). The processing system 106 utilizes network connectivity to access various resources. For example, the processing system 106 may communicate with a Digital Imaging and Communications in Medicine (DICOM) system, a Picture Archiving and Communication System (PACS), and / or a hospital information system via a network connection.

[0036]

[0061] At a high level, the ultrasound imaging intraluminal device 102 emits ultrasonic energy from a transducer array 124 contained in a scanner assembly 110 mounted near the distal end of the intraluminal device 102. The ultrasonic energy is reflected by tissue structures in a medium (such as the lumen 120) surrounding the scanner assembly 110, and ultrasonic echo signals are received by the transducer array 124. The scanner assembly 110 generates an electrical signal(s) representative of the ultrasonic echoes. The scanner assembly 110 can include one or more single ultrasonic transducers and / or the transducer array 124 in any suitable configuration, such as a planar array, a curved array, a circumferential array, an annular array, etc. For example, the scanner assembly 110 can be a one-dimensional array or a two-dimensional array in some cases. In some cases, the scanner assembly 110 can be a rotational ultrasonic device. The active area of ​​the scanner assembly 110 may include one or more transducer materials and / or one or more segments of ultrasonic elements (e.g., one or more rows, one or more columns, and / or one or more orientations) that may be uniformly or independently controlled or activated. The active area of ​​the scanner assembly 110 may be patterned or structured in a variety of basic or complex geometric shapes. The scanner assembly 110 may be arranged in a side-looking orientation (e.g., ultrasonic energy emitted perpendicular and / or orthogonal to the longitudinal axis of the endoluminal device 102) and / or in a forward-looking orientation (e.g., ultrasonic energy emitted parallel and / or along the longitudinal axis). In some cases, the scanner assembly 110 is structurally configured to emit and / or receive ultrasonic energy at an oblique angle relative to the longitudinal axis in the proximal or distal direction. In some embodiments, ultrasonic energy emission may be electronically steered by selective triggering of one or more transducer elements of the scanner assembly 110.

[0037]

[0062] The ultrasonic transducer(s) of the scanner assembly 110 may be a piezoelectric micromachined ultrasonic transducer (PMUT), a capacitive micromachined ultrasonic transducer (CMUT), single crystal, lead zirconate titanate (PZT), PZT composite, other suitable transducer types, and / or combinations thereof. In one embodiment, the ultrasonic transducer array 124 may include any suitable number of individual transducer elements or acoustic elements between 1 and 1000 acoustic elements, 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 ​​both larger and smaller.

[0038]

[0063] The PIM 104 forwards the received echo signals to a processing system 106 where an ultrasound image (including the flow information) is reconstructed and displayed on a monitor 108. The console or processing system 106 may include a processor and memory. The processing system 106 is operable to facilitate the features of the endoluminal imaging system 100 described herein. For example, the processor may execute computer readable instructions stored on a non-transitory tangible computer readable medium.

[0039]

[0064] The PIM 104 facilitates communication of signals between the processing system 106 and the scanner assembly 110 included in the endoluminal device 102. This communication includes providing commands to the integrated circuit controller chip(s) in the endoluminal device 102, selecting a particular element(s) on the transducer array 124 to be used for transmission and reception, providing transmit trigger signals to the integrated circuit controller chip(s) to activate transmitter circuitry to generate electrical pulses to excite the selected transducer array element(s), and / or accepting amplified echo signals received from the selected transducer array element(s) via amplifiers included on the integrated circuit controller chip(s). In some embodiments, the PIM 104 performs pre-processing of the echo data before relaying it 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 one embodiment, the PIM 104 also provides high and low voltage DC power to support operation of the intraluminal device 102 , including the circuitry within the scanner assembly 110 .

[0040]

[0065] The processing system 106 receives echo data from the scanner assembly 110 via 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 may be utilized in any suitable anatomical structure and / or body lumen of a patient. The processing system 106 outputs image data such that an image of the tube or lumen 120 is displayed on the monitor 108, such as a cross-sectional IVUS image of the lumen 120. The lumen 120 represents a structure filled with or surrounded by fluid, both natural and artificial. The lumen 120 is within the patient's body. The lumen 120 may be a blood vessel, such as an artery or vein, of the patient's vascular system, including the cardiovascular system, peripheral vascular system, neurovascular system, renal vascular system, and / or any other suitable lumen within the body. For example, device 102 may be used to examine any number of anatomical locations and tissue types, including, but not limited to, organs including the liver, heart, kidneys, gallbladder, pancreas, lungs, ducts, intestines, nervous system structures including the brain, thecal sac, spinal cord and peripheral nerves, the urinary tract, valves in the blood, chambers or other parts of the heart, and / or other systems of the body. In addition to natural structures, device 102 may be used to examine artificial structures, such as, but not limited to, heart valves, stents, shunts, filters and other devices.

[0041]

[0066] The controller or processing system 106 comprises a processing circuit having one or more processors in communication with a memory and / or other suitable tangible computer-readable storage medium. The controller or processing system 106 is configured to perform one or more aspects of the present disclosure. In some embodiments, the processing system 106 and the monitor 108 are separate components. In other embodiments, the processing system 106 and the monitor 108 are integrated into a single component. For example, the system 100 may comprise a touch screen device including a housing having a touch screen display and a processor. The system 100 may comprise any suitable input device, such as a touch sensitive pad or touch screen display, a keyboard / mouse, a joystick, buttons, etc., for a user to select options shown on the monitor 108. The processing system 106, the monitor 108, the input devices, and / or combinations thereof may be referred to as a controller of the system 100. The controller may be in communication with the device 102, the PIM 104, the processing system 106, the monitor 108, the input devices, and / or other components of the system 100.

[0042]

[0067] In some embodiments, the intraluminal device 102 includes some features similar to conventional solid IVUS catheters, such as the EagleEye® catheter available from Volcano Corporation and those disclosed in U.S. Patent No. 7,846,101, the entirety of which is incorporated herein by reference. For example, the intraluminal device 102 includes a scanner assembly 110 near a distal end of the intraluminal device 102 and a transmission wire bundle 112 that extends along the longitudinal body of the intraluminal device 102. The cable or transmission wire bundle 112 can include multiple conductors, including one, two, three, four, five, six, seven, or more conductors.

[0043]

[0068] The transmission wire bundle 112 terminates at a PIM connector 114 at the proximal end of the intraluminal device 102. The PIM connector 114 electrically couples the transmission wire bundle 112 to the PIM 104 and physically couples the intraluminal device 102 to the PIM 104. In one embodiment, the intraluminal device 102 further comprises a guidewire exit port 116. Thus, in some instances, the intraluminal device 102 is a rapid-exchange catheter. The guidewire exit port 116 allows a guidewire 118 to be inserted toward the distal end to guide the intraluminal device 102 through the lumen 120.

[0044]

[0069] The monitor 108 is a display device, such as a computer monitor or other type of screen. The monitor 108 is used to display selectable prompts, instructions, and visualizations of imaging data to the user. In some embodiments, the monitor 108 is used to provide the user with a procedure-specific workflow to complete an endoluminal imaging procedure. The workflow includes performing a pre-stent plan to determine the condition of the lumen and the feasibility of the stent, and a post-stent check to determine the status of the stent positioned in the lumen. The workflow is presented to the user as any of the displays or visualizations shown in FIGS. 5-7.

[0045]

[0070] The external imaging system 132 may be configured to acquire X-ray, radiological, angiographic / venographic (e.g., with contrast), and / or fluoroscopic (e.g., without contrast) images of the patient's body (including the vessel 120). The external imaging system 132 is also configured to acquire computed tomography images of the patient's body (including the vessel 120). The external imaging system 132 includes an external ultrasound probe configured to acquire ultrasound images of the patient's body (including the vessel 120) while located outside the body. In some embodiments, the system 100 includes other imaging modality systems (e.g., MRI) for acquiring images of the patient's body (including the vessel 120). The processing system 106 can utilize the images of the patient's body along with the endoluminal images acquired by the endoluminal device 102.

[0046]

[0071] 2 shows blood vessels (e.g., arteries and veins) in the human body. For example, the veins of the human body are labeled. Aspects of the present disclosure may relate to the peripheral vascular system, for example, veins in the torso or legs.

[0047]

[0072] An occlusion may occur in an artery or vein. An occlusion may generally represent a blockage or other structural configuration that causes a restriction in the flow of fluid through a lumen (e.g., an artery or vein) in a manner that is detrimental to the health of the patient, for example. For example, an occlusion narrows the lumen such that the cross-sectional area of ​​the lumen and / or the available space for fluid to flow through the lumen is reduced. If the anatomical tissue is a blood vessel, the occlusion is the result of narrowing due to compression (e.g., from an external vessel) and is the result of plaque accumulation, including plaque components such as, but not limited to, fibrous, fibrolipid (fibrous fat), necrotic core, calcification (high density calcium), blood, and / or different stages of thrombus (acute, subacute, chronic, etc.). In some cases, an occlusion may be referred to as a thrombus, a stenosis, and / or a lesion. Generally, the composition of the occlusion depends on the type of anatomical tissue being evaluated. Healthier parts of the anatomical tissue have a uniform or symmetrical profile (e.g., a cylindrical profile with a circular cross-sectional profile). An occlusion does not have a uniform or symmetric profile. Thus, a diseased or compressed portion of an anatomical structure with an occlusion has an asymmetric and / or possibly irregular profile. An anatomical structure may have one occlusion or multiple occlusions.

[0048]

[0073] The accumulation of occlusions (e.g., thrombus, deep vein thrombosis or DVT, chronic total occlusion or CTO, etc.) is one way in which the cross-sectional area of ​​veins in the peripheral vasculature (e.g., torso, abdomen, groin, legs) is reduced. Other anatomical structures that contact a vein may also reduce its cross-sectional area, thereby restricting blood flow therethrough. For example, arteries or ligaments in the torso, abdomen, groin, or legs may press against the vein, causing the vein to change shape and reduce its cross-sectional area. Such reduction in cross-sectional area resulting from contact with other anatomical structures may be referred to as compression, in that the walls of the vein are compressed as a result of contact with the artery or ligament.

[0049]

[0074] 3 shows a blood vessel 300 that includes a compression 330. The compression 330 occurs external to the vessel wall 310 and restricts the flow of blood 320. The compression may be caused by other anatomical structures external to the blood vessel 300, including, but not limited to, tendons, ligaments, or nearby lumens.

[0050]

[0075] 4 shows a blood vessel 300 containing a constriction 330 and having a stent 440 expanded therein to restore flow. The stent 440 displaces and blocks the constriction 330, pushing the vessel wall 310 outward, thus reducing flow restriction for the blood 320. Other treatment options to relieve the obstruction include, but are not limited to, thrombectomy, ablation, angioplasty, and drugs. However, in the majority of cases, it is highly desirable to obtain accurate and timely intravascular images of the affected area, along with accurate and detailed knowledge of the location, orientation, length, and volume of the affected area before, during, or after the procedure.

[0051]

[0076] 5-9 and 10-21 (formerly 3-19) illustrate exemplary screen displays or graphical user interfaces (GUIs). The screen displays may be shown on a display of the system 100, such as a display of a console, cart, bedside controller, mobile device (e.g., a smart phone, tablet, personal digital assistant or PDA), laptop computer, desktop computer, etc. The display may be a touch screen display. The display may be in communication with a computer having processing circuitry (e.g., one or more processors and memory). The processing circuitry may generate and output display data to cause the display to show the screen displays of FIGS. 5-9 and 10-21. The computer, processing circuitry, and / or processor may also be in communication with a user interface to which a user provides input. The input may be the selection of an item on the screen display. The user interface may be a touch screen display in some instances. The user interface may be a keyboard, a mouse, a controller with buttons, a joystick, etc.

[0052]

[0077] 5-9 show screen displays that provide user guidance during IVUS pullback in the peripheral vasculature. The screen displays highlight segments of the vasculature, label the segments, color code the segments, and automatically provide reference and compression measurements (e.g., cross-sectional lumen area, diameter, etc.) within each of the segments. Additionally, the screen displays provide real-time feedback to the user on the pullback speed, as a consistent pullback speed within a desired speed range is necessary for the generation of clear intravascular images (e.g., IVUS images). 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 arrive at the correct pullback speed to acquire a sufficient amount of high quality IVUS data.

[0053]

[0078] As shown, the screen displays of Figures 5-9 include a graphical representation of the peripheral vasculature (e.g., the inferior vena cava, abdominal vena cava, renal veins, left and right common iliac veins, left and right common femoral veins, etc.) in which an intraluminal ultrasound device (e.g., an IVUS catheter) is located. The graphical representation may be an illustration or cartoon of the vasculature, and / or an X-ray / CT / MRI image. For example, the graphical representation may be a roadmap image. The graphical representation may be formed from an acquired IVUS image. The graphical representation shows the longitudinal extent of the vasculature and may be referred to as a longitudinal view or an image longitudinal view (ILD).

[0054]

[0079] A graphical representation of the IVUS catheter is also displayed, including a flexible elongate member located within the vasculature and a transducer array at a distal portion of the flexible elongate member. The position of the IVUS catheter within the vasculature changes from FIG. 5 to FIG. 9 during imaging pullback. As shown in FIG. 5, the IVUS catheter starts with the transducer array located within the inferior vena cava or abdominal vena cava. During pullback, the transducer array moves longitudinally within the vasculature through the right iliac vein (e.g., FIG. 7) and into the right femoral vein (e.g., FIG. 9). The position of the transducer is determined, for example, through co-registration of the IVUS image with an external image (e.g., fluoroscopic image) or estimated based on user input identifying which segment of the vasculature the transducer is in.

[0055]

[0080] FIG. 5 illustrates an exemplary cartoon roadmap or virtual venogram 500 screen display at the start of a pullback procedure of an imaging catheter 510 in the inferior vena cava or abdominal vena cava 530, according to at least one embodiment of the present disclosure. A speed indicator 520 is provided to provide navigational information and 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 the image quality of the IVUS images at those locations. Different colors, shading, text, numerical values, etc. in the speed indicator 520 can alert the user as to whether to accelerate (go faster), decelerate (go slower), and / or maintain speed during pullback. For example, a speed gauge with numerical values ​​is illustrated in FIGS. 5-9. All or a portion of the speed gauge may be colored to guide the user. For example, in FIGS. 5, 6, and 7, a green highlight on the speed gauge indicates that the user's pullback speed is appropriate and should be maintained.

[0056]

[0081] Also visible are the left and right common iliac veins (CIV) 540, the left and right external iliac veins (EIV) 550, the left and right common femoral veins (CFV) 560, and the left and right femoral veins (F) 570.

[0057]

[0082] 6 illustrates an exemplary cartoon roadmap or screen display of a 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. In this example, the virtual venogram 500 includes a text label 634 adjacent to the vasculature to identify the inferior vena cava 530 ("IVC") as the segment of the vasculature currently occupied by the catheter 510, which now corresponds to the highlighted segment in the virtual venogram 500. For example, the label may be an abbreviation or full form of the name of the corresponding vasculature segment.

[0058]

[0083] The screen display also automatically provides a statistically representative reference value 636 associated with the vasculature segment 530 adjacent to the vasculature segment 530. The reference value is an expected value for a healthy vessel, for example, based on literature. The reference value is a value for a healthy vessel for a particular patient. For example, the reference value is a numerical value of a cross-sectional lumen area. The numerical values ​​shown in FIG. 6 are examples only and do not necessarily reflect values ​​associated with a particular anatomy. In this example, the inferior or abdominal vena cava 530 is colored, shaded, and / or highlighted in the virtual venogram 500, such as with a first color (e.g., blue). The color for the IVC segment may be different from the color associated with other vasculature segments to indicate that it is the start of a pullback. The color of the segment may also indicate that the compression measurement is not determined from the acquired IVUS data, or that the compression measurement is equal or approximately equal to the reference measurement.

[0059]

[0084] In this example, the speed indicator 520 is colored green to indicate that the pullback speed is within the desired range.

[0060]

[0085] 7 illustrates a screen display of an exemplary virtual venogram 500 after the transducer array 124 at the end of the catheter 510 has been moved to the right 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 right common iliac vein 540. If the catheter were in the patient's left leg rather than the patient's right leg as in this example, the CIV 540 in the left half of the virtual venogram 500 would be labeled and the CIV 540 in the right half of the virtual venogram 500 would be blank.

[0061]

[0086] In this example, as the transducer array 124 moves through the vasculature, 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 is a numerical value of the cross-sectional lumen area for a particular patient, or a % compression value. At that point, the compression value is automatically calculated based on the acquired IVUS data and then output on the screen display adjacent to the virtual venogram 500. In this example, the CIV segment 540 is colored based on a comparison of the reference value and the compression value. Two position indicators 710 and 720 are also visible, marking the boundaries of the CIV segment 540. As the pullback continues and the catheter 510 is withdrawn downward (i.e., distally, or toward the patient's foot in this example) through the vasculature, the transducer array 124 eventually passes the position indicator 720 and the transducer array 124 is no longer in the CIV segment 540.

[0062]

[0087] In this example, the speed indicator 520 is colored green to indicate that the pullback speed is within the desired range.

[0063]

[0088] 8 illustrates a screen display of an exemplary cartoon roadmap or virtual venogram 500 after the transducer array 124 at the end of the catheter 510 has been moved to the right 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. The EIV segment 550 is colored differently than the IVC segment 530 and the CIV segment 540 based on a comparison of the reference value 856 and the compression value 858. For example, when the compression value is equal to or greater than 50% of the reference value, the EIV segment may be colored a third color (e.g., red) to indicate that the amount of compression is potentially harmful to the patient.

[0064]

[0089] FIG. 8 also shows that the speed gauge 520 indicates that the pullback speed is too fast. At that point, a larger portion of the speed gauge is colored (e.g., compared to FIGS. 5-7) to indicate a faster pullback speed. In this example, the speed gauge 520 is colored red to provide the user with real-time feedback that they should slow down their pullback speed. Also visible are position markers 710 and 720, which now mark the proximal and distal boundaries of the EIV segment 550.

[0065]

[0090] FIG. 9 illustrates a screen display of an exemplary virtual venogram 500 after the transducer array 124 at the end of the catheter 510 has been moved to the right common femoral vein 560, in accordance with at least one embodiment of the present disclosure. Vascular segments were sequentially highlighted on the virtual venogram 500 as the transducer array passed over them. A text label 964 ("CFV") is provided adjacent to 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. The CFV segment 560 is colored differently than the IVC, CIV, and EIV segments based on a comparison of the reference value and the compression value. For example, when the compression value is greater than 50% of the reference value, the segment 560 may be colored a fourth color (e.g., yellow) to indicate that the amount of compression is not harmful to the patient.

[0066]

[0091] 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 right femoral vein 570 is also labeled ("F"), but no reference value, compression value, or color is displayed because the transducer array 515 has not yet been pulled back into the right F segment 570.

[0067]

[0092] In this example, the speed indicator 520 is colored green to indicate that the pullback speed is within the desired range.

[0068]

[0093] FIG. 10 shows a flow diagram illustrating a method 1000 followed by the pullback velocity management system. In step 1001, a user inputs initialization data, if any, into the system. Such data may include, but is not limited to, procedure type, disease type, entry point into the patient's vasculature, direction of travel, or information regarding the limb or other body part to be examined. In step 1002, the clinician moves the imaging probe or ultrasound transducer array 124 of the catheter 102, for example, to a position advanced through the vessel or lumen to a point where the pullback procedure can begin. In some embodiments, this is done by the clinician without assistance from the system. In other embodiments, the system provides instructions to the clinician. In step 1003, the clinician or other user indicates to the system that the recording process can begin. This is done, for example, by activating a record button on a touch screen. The clinician then begins to move the catheter (e.g., by pulling the catheter back through the vasculature of interest) and the system captures a sufficient number of initial frames (e.g., at least two initial frames) to begin performing velocity calculations. In step 1004, the system running on the processor 106 uses image analysis and machine learning or pattern recognition algorithms to measure the pullback speed of the catheter to observe frame-to-frame changes in the IVUS images over the past few frames (e.g., the past 10 or 100 frames), such as vessel taper rate and branch vessel path, and other anatomical landmarks and features for the area under investigation. Based on representative anatomical dimensions for a general human, demographic group, or specific patient, the frame rate (i.e., the known time interval between successively captured images) can be used to infer, in real time or near real time, the longitudinal translation speed or pullback speed of the imaging probe. In one example, the ideal pullback speed is between 2 mm / sec and 5 mm / sec. If insufficient frames have been collected so far to calculate the speed, the speed is not calculated.

[0069]

[0094] In step 1005, method 1000 displays a representation of the pullback speed (e.g., speed indicator 520, shown, for example, in FIGS. 5-9) on monitor 108, if available. The system further displays a recommendation to the user indicating whether the pullback speed is too fast or too slow, i.e., whether the pullback speed should be increased or decreased so that it falls within a specified optimal range for capturing a clear image (e.g., an IVUS image). In step 1006, the next image is captured by imaging catheter 102, and in step 107, execution of the method returns to step 1004, with the newly captured image now being part of the growing data set used to determine the pullback speed. Execution continues to loop between 1004 and 1007 as shown, until interrupted by the user (e.g., by activating a STOP or EXIT control).

[0070]

[0095] Examples of boundary detection, image processing, image analysis, and / or pattern recognition can be found in U.S. Pat. No. 6,200,268 entitled "VASCULAR PLAQUE CHARACTERIZATION," issued on Mar. 13, 2001 to D. Geoffrey Vince, Barry D. Kuban, and Anuja Nair as inventors; U.S. Pat. No. 6,381,350 entitled "INTRAVASCULAR ULTRASONIC ANALYSIS USING ACTIVE CONTOUR METHOD AND SYSTEM," issued on Apr. 30, 2002 to Jon D. Klingensmith, D. Geoffrey Vince, and Raj Shekhar as inventors; U.S. Pat. No. 6,381,350 entitled "INTRAVASCULAR ULTRASONIC ANALYSIS USING ACTIVE CONTOUR METHOD AND SYSTEM," issued on Jul. 11, 2006 to Anuja Nair, D. Geoffrey Vince, Jon D. Klingensmith, and Barry D. Kuban ... No. 7,074,188 entitled "NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD" issued on February 13, 2007 to D. Geoffrey Vince, Anuja Nair and Jon D. Klingensmith as inventors; U.S. Patent No. 7,175,597 entitled "NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD" issued on May 8, 2007 to Jon D. Klingensmith, Anuja Nair, Barry D. Kuban and D. Geoffrey Vince as inventors; U.S. Patent No. 7,215,802 entitled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION" issued on April 15, 2008 to Jon D. Klingensmith, D. Geoffrey Vince, Anuja Nair and Barry D. Kuban as inventors; No. 7,359,554 entitled "BORDER" and Jon D. Klingensmith, Anuja Nair, Barry D. Kuban and D.No. 7,463,759, entitled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," issued on December 9, 2008, with Geoffrey Vince as the inventor.

[0071]

[0096] 11-12 show screen displays providing user guidance during and after IVUS pullback in the peripheral vasculature. The screen displays provide auto-label based on arterial information, auto-label based on image analysis, bookmark thumbnails on the sides, roadmap view (cartoon), segment mapping, longitudinal and compression indicators, auto-labels on all relevant segments, user selected access points, image adjustments, and pullback speed indicators.

[0072]

[0097] 11A shows a screen display 1100 of a virtual venogram at the start of a pullback procedure, in accordance with at least one embodiment of the present disclosure. As indicated by a start indicator 1110, the user indicates where on the anatomy they are beginning the pullback on the graphical view of the vasculature displayed in the virtual venogram 500. This information serves as input to the IVUS pullback venogram system to assist in automatically identifying, via image recognition, the different vein segments 530, 540, 550, 560, and 570 as the IVUS transducer array 124 passes through them, and automatically inferring the speed of pullback for the transducer array 124 through the different vein segments.

[0073]

[0098] 11B illustrates a screen display 1100 of a live view during a pullback procedure, according to at least one embodiment of the present disclosure. A virtual venogram 500, which serves as a roadmap in the live view 1100, provides a longitudinal view of the anatomy surrounding the transducer array 124 and automatically indicates where the transducer array 124 is located within the body. In some embodiments, a co-registered X-ray, CAT scan, or fluoroscopic image is used as a roadmap instead of or in addition to the virtual venogram 500. Aspects of registration are described, for example, in U.S. Pat. Nos. 7,930,014 and 8,298,147, which are incorporated by reference herein in their entireties. 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.).

[0074]

[0099] FIG. 12 illustrates a screen display 1100 during pullback, e.g., during recording of IVUS data, according to at least one embodiment of the present disclosure. A current frame indicator 1215 indicates 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 are also provided (e.g., abbreviations for vasculature segments, e.g., CIV, EIV, CFV, etc.). The IVUS frames are automatically labeled based on image analysis. In this example, the current location of the transducer array is identified as the external iliac vein 550, and thus the EIV label preset 1220 is highlighted or illuminated. A pullback speed indicator 520 provides guidance to the clinician or other user for a stable pullback speed. The pullback speed indicator 520 can be a series of blocks that are filled based on speed (e.g., more blocks indicate a faster speed, fewer blocks indicate a slower speed). A cross-sectional IVUS image 1010 indicates a current frame, and an automatic label 1240 may be generated using image analysis for a label preset represented for a current frame indicator 1215, for example, by an abbreviation of a vasculature segment. When a user presses a bookmark option and / or a label preset option, a bookmark thumbnail 1250 appears. A direction indicator 1260 is also included, indicating, for example, an orientation or direction of movement of the transducer array. Anterior (A), posterior (P), medial (M), lateral (L), and / or other suitable direction labels may be used. The direction indicator may include a compass arrow that moves based on the direction of movement. Anatomy 1270 of interest (e.g., a compression or thrombus) within the IVUS image 1010 may be colored, shaded, and / or highlighted.

[0075]

[0100] 13-15 show screen displays providing user guidance during IVUS pullback in the peripheral vasculature. The screen displays advantageously assist the physician or user in navigating to an area of ​​interest. The screen displays provide suggested compression areas, navigation support, anterior and posterior orientation, automatic border detection and display on demand, automatic border detection and display when destination is reached (e.g., desired area of ​​interest, and pullback speed indication). FIGS. 13-15 may be displayed as part of navigation during live IVUS.

[0076]

[0101] 13 shows a screen display 1300 associated with navigating the IVUS imaging catheter 102 to a suggested location (e.g., compression or blockage) within the vasculature. The screen display may include a selection of image settings (e.g., filters) 1310 (e.g., labeled "G1", "G2", "G3", etc.). The filters may be pre-set image settings (e.g., grayscale, contrast, gain, focus, and / or other image settings) for display of cross-sectional IVUS images. In this example, the first image setting 1310 ("G1") is selected.

[0077]

[0102] A live tomographic IVUS image 1010 of a vessel 1360 is shown in the top center portion of the screen display. Orientation markers 1320 (in this example, "A" for anterior and "P" for posterior) are provided with the IVUS image 1010 to provide orientation information for the IVUS image. The right side of the screen display also includes an anatomical plane indicator 1330 to provide additional orientation information for the IVUS image and / or catheter, such as where the catheter is currently located, which direction the catheter is moving, etc. A roadmap image 500 of the vasculature (e.g., an angiogram, venogram, or virtual venogram) is displayed in the bottom center portion of the screen display. A marker 1340 indicating the current location of the catheter (e.g., the location of the transducer array 124) is shown on the roadmap image (e.g., a glowing circle or a circle with a light ray around it). In some embodiments, this location is determined automatically from the images captured by the imaging catheter 102. In other embodiments, the location is determined through image analysis of external images captured by external imaging system 132. Markers 1370 are also shown on roadmap image 500 (e.g., medallions representing a destination or completion line) indicating the suggested compression location to be evaluated. Markers 1340 and 1370 allow the user to visually assess the distance of the catheter from the suggested area of ​​interest. In this example, an automatic boundary toggle 1350 is provided at the top right of screen display 1300.

[0078]

[0103] A speed indicator 520, such as a speed gauge, is also provided on the left side of the screen display to indicate the pullback speed. The speed indicator 520 resembles an automobile speedometer, for example, by including an arrow or needle that indicates the current rate of travel. Areas (e.g., quadrants) of the speed gauge 520 can be highlighted, colored, or shaded to indicate a desired speed. The speed indicator 520 can also provide a numerical value for the current speed and / or a recommended speed.

[0079]

[0104] 14 illustrates a screen display 1300 after the IVUS imaging catheter 102 has been moved to the indicated compression within the vasculature. At that point, the screen display provides feedback to the user that the catheter 102 (e.g., the transducer array 124) is in the area of ​​interest. For example, a colored, highlighted, and / or shaded (e.g., colored orange) border 1410 may be provided around the tomographic IVUS image 1010 of the vessel 1360 to indicate that the IVUS image 1010 is of the area of ​​interest. Color, highlighting, and / or shading, such as orange, may be provided for the current location marker 1340 on the roadmap image 500 (and / or for a ray of light around the marker) to indicate that the current location of the IVUS catheter transducer array 124 is in the area of ​​interest. In that regard, the color (e.g., black) of the current location marker 1340 (and / or the light beam or other highlighting around the marker 1340) in Figure 13 differs from the color of the current location marker (and / or the light beam or other highlighting around the marker, e.g., red) in Figure 14. This is because the current location marker in Figure 13 indicates that the IVUS catheter is away from the area of ​​interest (indicated by the medal-shaped marker in Figure 13), whereas in Figure 14 the IVUS transducer array 124 is in the area of ​​interest.

[0080]

[0105] Also visible in FIG. 14 are image settings 1310, orientation markers 1320, anatomical plane indicators 1330, auto boundary toggle 1350, and speed indicator 520.

[0081]

[0106] FIG. 15 shows the screen display 1300 with the automatic boundary toggle 1350 turned on by the user. The processing system 106 can execute algorithm(s) for performing image analysis, such as for automatically determining the boundary of the lumen 1360 in the cross-sectional IVUS image 1010. A measurement display 1550 shows an automatically calculated cross-sectional lumen area and / or lumen diameter, either or both of which may be calculated based on the determined boundary of the lumen. The calculated measurement(s) 1550 may be displayed, for example, on the right side of the screen display, adjacent to the IVUS image. The directional markers 1320 (e.g., marking A and P, or anterior and posterior directions) may be reoriented as needed to provide orientation information for the IVUS image 1010. For example, the directional markers 1320 are provided to the left and right of the IVUS image in FIG. 15, as opposed to above and below the IVUS image in FIGS. 13 and 14. 15 may include two arrows 520a and 520b on a gauge. For example, one arrow may indicate a current pullback speed, while the other arrow may indicate a recommended pullback speed. The arrows 520a and 520b may be visually distinguished by coloring, shading, highlighting, style, etc.

[0082]

[0107] Also visible in FIG. 15 are the roadmap image 500, image settings 1310, anatomical plane indicator 1330, position marker 1340, and shaded boundary 1410.

[0083]

[0108] 16a-d provide various examples of speed indicators 520 that provide feedback to the user on the pullback rate of the IVUS catheter 102. The speed indicators 520 may be provided adjacent to or proximate to the roadmap image 500. FIG. 16a shows a circular speed gauge 520 with a zero value at the 12 o'clock position. Greater speeds may be indicated in a clockwise direction. An arrow or needle 520a on the gauge 520 indicates the current speed. Wedge and / or pie shaped areas of the circular gauge are colored, highlighted, and / or shaded to indicate an ideal speed range 1620, including a minimum ideal speed, a maximum ideal speed, and a range of speeds between the minimum ideal speed and the maximum ideal speed. In that regard, speeds slower than the ideal speed range 1620 and speeds faster than the ideal speed range 1620 may lead to improper collection of IVUS data, which may impair IVUS image quality. FIG. 16b shows a rectangular bar shaped speed gauge 520. The zero position is at the left end of the gauge, and increasing values ​​are shown to the right. The current speed is indicated by a marker 520a with a triangular base and an arm extending from the triangle and crossing the gauge at a right angle. An ideal speed range 1620 is indicated on the gauge by colored, highlighted, and / or shaded portions. FIG. 16c shows a triangular speed gauge 520. The zero position is at the left end of the gauge 520, and increasing values ​​are shown to the right. The height of the gauge 520 increases with increasing speed values ​​on the right. An ideal speed range 1620 is indicated on the gauge by colored, highlighted, and / or shaded portions. FIG. 16d shows an additional type of speed indicator 520, where a circular indicator grows and shrinks in proportion to the speed, and a donut-shaped shaded area indicates the desired speed range. If the boundary of the circular indicator is within the shaded donut, the speed is within the desired range. If the boundary of the circular indicator is within the "hole" of the donut, the speed is too slow, if the boundary of the circular indicator is outside the outer edge of the donut, the speed is too fast. A speed that is too fast or too slow is further indicated by a color change.

[0084]

[0109] Other types of speed indicators may be used in place of or in addition to those described above, including graphical speed indicators, schematic speed indicators, alphanumeric speed indicators, voice speed indicators, auditory tone speed indicators, and tactile or haptic speed indicators. Also seen in Figures 16a-16c is a roadmap image 500 including a representation of the catheter 102 and transducer array 124, along with a color-coded trajectory 1610 indicating the past position of the transducer array or sensor head 124 during pullback. In one example, the color of the trajectory 1610 indicates whether the pullback speed was too slow (e.g., red), too fast (e.g., yellow), or within an ideal range 1620 (e.g., green).

[0085]

[0110] 17 illustrates a screen display 1700 during pullback, e.g., 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, registered external image, or virtual venogram 500 of the vasculature is shown. Portions 1710 of the vasculature 1720 for which IVUS data has already been collected are highlighted, colored, and / or shaded. For example, vessel boundaries in the region 1710 where pullback has already been performed are bold, while other areas of the vessel 1720 are shown lighter. A thick solid line 1710 may be used for the vessel boundaries, and a thick dashed line 1124 may be used when crossing a branching vessel. As the pullback progresses, more and more of the vessel 1720 is visually highlighted 1710. At that point, a map 500 of the vasculature 1720 is built up during the pullback. An anterior (ANT) portion 1730 and a posterior (POST) portion 1740 of the vasculature are labeled on the roadmap image 500, and the pullback is performed with the transducer array 124 moved longitudinally from the anterior portion 1730 to the posterior portion 1740. Along the bottom of the display, a horizontal ILD 1020 is shown. The ILD 1020 is formed from the IVUS data during the pullback. As shown, the ILD 1020 is also built during the pullback, and as the pullback progresses, more and more IVUS image frames 1010 are added to the ILD 1020. An anterior (ANT) portion 1730 and a posterior (POST) portion 1740 of the vasculature 1720 are labeled on the roadmap image 500. A compass 1260 is provided in the center of the screen display 1700. For example, the anterior direction (ANT) may always be at the top (e.g., the 12 o'clock position). The compass arrow 1260 can change direction based on the orientation or direction of movement of the transducer array within the vasculature 1720 during pullback.

[0086]

[0111] A pullback speed indicator 520 is provided at the top right of the screen display. The pullback speed indicator 520 may display the speed of the manual pullback numerically. The indicator may also include a graphical representation (e.g., symbols) of whether the speed is too fast, too slow, or correct. For example, a check mark may indicate that the pullback speed is correct.

[0087]

[0112] 18 illustrates an exemplary screen display 1700 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, a greater length of the vasculature 1720 has been highlighted (1710, 1124) compared to FIG. 17 to indicate that IVUS data has been acquired from a greater length of the vasculature 1720. Similarly, a greater length of the ILD 1020 has been filled with acquired IVUS image frames 1010. The direction label (ANT) of the compass 1260 or the arrow of the compass 1260 may blink 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.

[0088]

[0113] 19 illustrates an exemplary screen display 1700 at or near the end of an 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, all or nearly all of the length of the vasculature 1720 under investigation is highlighted (1710, 1124), indicating that IVUS data 1010 has been acquired from nearly the complete length. Similarly, all or nearly all of the length of the ILD 1020 has been filled with acquired IVUS image frames 1010.

[0089]

[0114] A pullback speed indicator 520 in the top right of the screen display 1700 indicates that the pullback speed is too fast. For example, a symbol (e.g., an exclamation point) and / or coloring of the numeric speed value (e.g., red) may be used to indicate to the user that the pullback speed should be slowed down.

[0090]

[0115] FIG. 20 a shows a cross-sectional endoluminal image (eg, an IVUS image) 2000 of a vessel 300 having a vessel wall 310 .

[0091]

[0116] Figure 20b shows a cross-sectional endoluminal image (e.g., an IVUS image) 2000 of a vessel 300 with the vessel wall 310 further along in the pullback than in the image in Figure 20a, as indicated by the larger frame number 2020b. In this image, a branching vessel 2010 has begun to separate from the vessel 300.

[0092]

[0117] FIG. 20c shows a cross-sectional endoluminal image (e.g., IVUS image) 2000 of a vessel 300 with the vessel wall 310 having followed a pullback further than in the image in FIG. 20b, as indicated by the larger frame number 2020c. In this image, a branch vessel 2010 is completely separated from the vessel 300. Since the frame rate (e.g., 12 fps or 30 fps) is known, the passage or other anatomical landmarks of the branch vessel 2010 can be related to the physical dimensions of a reference anatomy for a typical human body, a representative demographic group, or a known patient anatomy. Thus, the rate of change of the anatomical landmarks from one frame to the next (and particularly across multiple frames) can be used to infer the velocity of the endoluminal probe 102 through the vessel 300.

[0093]

[0118] 21a shows a cross-sectional endoluminal image (eg, an IVUS image) 2000 of a vessel 300 having a vessel wall 310. A diameter measurement 2010a indicates the width of the vessel from which the cross-sectional area may be determined.

[0094]

[0119] FIG. 21b shows a cross-sectional endoluminal image (e.g., IVUS image) 2000 of a vessel 300 with the vessel wall 310 having progressed further along the pullback than in the image in FIG. 20a, as indicated by the larger frame number 2020b. In this image, the vessel diameter and cross-sectional area are smaller. The frame rate of the endoluminal imaging system 100 may then be related to a known vessel taper rate for the vessel of interest in the general human body, a representative demographic group, or a known patient anatomy. Thus, the rate of change of vessel diameter or area from one frame to the next (and particularly across multiple frames) may be used to infer the velocity of the endoluminal probe 102 through the vessel 300.

[0095]

[0120] During IVUS pullback, the user pulls (or pushes) the catheter across the lumen of the vessel so that an IVUS image can be captured. Currently, many IVUS catheters for peripheral vascular interventions (e.g., PV0.014, PV0.018, and PV0.035 catheters from Philips Volcano) only support phased array technology and have no control over the speed across the pullback. To guide the physician to reach and maintain a constant speed while performing the pullback, a "speed indicator" is included on the IVUS screen, as shown, for example, in Figures 6, 7, 9, 11, 13, 14, and 16-19. The speed indicator shows the IVUS operator the actual speed within the vessel. The speed indicator can be activated during the recording phase (e.g., after the user selects the record button to store the IVUS data, such as at the beginning of the pullback). The speed indicator communicates to the operator when the speed is not within the correct range and suggests the correct speed range to ensure sufficient pullback recording. As shown in Fig. 8, Fig. 9, Fig. 13, Fig. 15, and Fig. 19, a speed that is too fast / too slow can be suggested by color coding. The speed indicator and color coding can guide the physician to perform a steady pullback throughout the vessel. The speed indicator can provide a measure of speed or be considered in a way that communicates to the user the correct range of speed to reach and maintain during the pullback. Different representations of the speed indicator while performing the pullback are contemplated (e.g., a car-like speed indicator with quadrants indicating the current moving rate and the desired speed as in Fig. 16a, and / or a color and square bar speed indicator as in Fig. 16b). Due to this constant speed, a rough estimate of the pullback length can be derived, which can be extremely useful for the physician to determine the stent length immediately after the pullback and measurement review.

[0096]

[0121] 22 is a schematic diagram of a processor circuit 2250 according to an embodiment of the present disclosure. The processor circuit 2250 may be implemented in the ultrasound imaging system 100 or other devices or workstations (e.g., third party workstations, network routers, etc.) or implemented on a cloud processor or other remote processing unit, as needed to perform the methods. As shown, the processor circuit 2250 includes a processor 2260, a memory 2264, and a communication module 2268. These elements are in direct or indirect communication with each other, for example, via one or more buses.

[0097]

[0122] The processor 2260 includes any combination of a central processing unit (CPU), digital signal processor (DSP), ASIC, controller, or other related logic devices, including general purpose computing devices, reduced instruction set computing (RISC) devices, application specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or mechanical and quantum computers. The processor 2260 also comprises other hardware devices, firmware devices, or any combination thereof, configured to perform the operations described herein. The processor 2260 may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0098]

[0123] The memory 2264 includes cache memory (e.g., processor 2260 cache memory), 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 one embodiment, the memory 2264 includes a non-transitory computer readable medium. The memory 2264 stores instructions 2266. The instructions 2266 include instructions that, when executed by the processor 2260, cause the processor 2260 to perform the operations described herein. The instructions 2266 are also referred to as code. The terms "instructions" and "code" should be interpreted broadly to include any type of computer readable statement(s). For example, the terms "instructions" and "code" refer to one or more programs, routines, subroutines, functions, procedures, etc. "Instructions" and "code" may include a single computer readable statement or multiple computer readable statements.

[0099]

[0124] The communications module 2268 may include any electronic and / or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 2250 and other processors or devices. In that regard, the communications module 2268 may be an input / output (I / O) device. In some instances, the communications module 2268 facilitates direct or indirect communication between various elements of the processor circuit 2250 and / or the ultrasound imaging system 100. The communications module 2268 communicates within the processor circuit 2250 through a number of methods or protocols. Serial communications protocols include, but are not limited to, US SPI, I2C, SPI, SPI 2280, SPI 2281, SPI 2282, SPI 2283, SPI 2284, SPI 2285, SPI 2286, SPI 2287, SPI 22888, SPI 22888, SPI 22888, SPI 2289, SPI 2290, SPI 2291, SPI 2292, SPI 2293, SPI 2294, SPI 2295, SPI 2296, SPI 2297, SPI 2298, SPI 2299, SPI 2291, SPI 2298, SPI 2299, SPI 2291, SPI 2298, SPI 2299, SPI 2291, SPI 2296, SPI 2297, SPI 2298, SPI 229 ...1, SPI 2298, SPI 2C, RS-232, RS-485, CAN, Ethernet, ARINC429, MODBUS, MIL-STD-1553, or any other suitable method or protocol. Parallel protocols include, but are not limited to, ISA, ATA, SCSI, PCI, IEEE-488, IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communications are bridged by UART, USART, or other suitable subsystems.

[0100]

[0125] External communication (including, but not limited to, software updates, firmware updates, pre-configured shares between the processor and a central server, or readings from the ultrasound device) is accomplished using any suitable wireless or wired communication technology, such as a cable interface, such as a 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 may be used to establish connectivity with cloud services, for transmitting data, and for receiving software patches. The controller may be configured to communicate with a remote server or a local device, such as a laptop, tablet, or handheld device, or may include a display capable of showing status variables and other information. Information may also be transferred onto a physical medium, such as a USB flash drive or memory stick.

[0101]

[0126] Several variations are possible to the examples and embodiments described above. For example, the pullback speed management system may be employed in anatomical systems within the body other than those described, or may be employed to image other disease types, object types, or procedure types other than those described. The techniques described herein apply to various types of endoluminal imaging sensors, whether currently existing or later developed.

[0102]

[0127] Accordingly, the logical operations making up the embodiments of the technology described herein are variously referred to as operations, steps, objects, elements, components, or modules. Moreover, it should be understood that they may be performed in any order unless expressly claimed otherwise or a particular order is inherently required by the language of the claims. All directional references, e.g., upper, lower, inside, outside, upward, downward, left, right, side, front, back, top, bottom, upward, downward, vertical, horizontal, clockwise, counterclockwise, proximal, and distal, are merely used for identification to aid the reader's understanding of the claimed subject matter, and do not create limitations with respect to the location, orientation, or use of the pullback speed management system, in particular. Connection references, e.g., attached, coupled, connected, and joined, should be interpreted broadly and include intermediate members between collections of elements and relative movement between the elements, unless otherwise specified. Thus, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship to each other. The term "or" shall be interpreted to mean "and / or" rather than "exclusive or." Unless otherwise stated in the claims, stated values ​​shall be interpreted as exemplary only and not as limiting.

[0103]

[0128] The above specification, examples, and data provide a complete description of the structure and use of exemplary embodiments of the pullback speed management system defined in the claims. Although various embodiments of the claimed subject matter have been described above in some detail, or with reference to one or more individual embodiments, those skilled in the art can make numerous modifications to the disclosed embodiments without departing from the spirit or scope of the claimed subject matter. Still other embodiments are contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be construed 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 defined in the following claims.

Claims

1. A system for endoluminal imaging of a vessel, comprising a display, an endoluminal imaging catheter, and a processor circuit for communicating with the endoluminal imaging catheter, comprising: The display comprises: Display a virtual venogram, which represents a graphical view of the vascular system; enabling a user to select a location on the virtual venogram at which pullback of the endoluminal imaging catheter begins; The processor circuit includes: automatically identifying different vein segments as an imaging component of the intraluminal imaging catheter passes through the vessel based on image recognition; outputting to the display a label of the identified vein segment and a current frame provided by the intraluminal imaging catheter. system.

2. The processor circuit further comprises: obtaining a roadmap image of the vasculature from an external imaging device; registering the roadmap image with the virtual venogram; The system of claim 1 , further comprising: outputting to the display a current position of the imaging component relative to the virtual venogram.

3. The system described in claim 1 or 2, wherein the processor circuit further automatically determines a pullback speed of the intraluminal imaging catheter based on image recognition.

Images