WO2025103969A1 - Détection de limite d'image intravasculaire en réponse à la localisation à l'intérieur d'une région et systèmes, dispositifs et procédés associés - Google Patents
Détection de limite d'image intravasculaire en réponse à la localisation à l'intérieur d'une région et systèmes, dispositifs et procédés associés Download PDFInfo
- Publication number
- WO2025103969A1 WO2025103969A1 PCT/EP2024/081934 EP2024081934W WO2025103969A1 WO 2025103969 A1 WO2025103969 A1 WO 2025103969A1 EP 2024081934 W EP2024081934 W EP 2024081934W WO 2025103969 A1 WO2025103969 A1 WO 2025103969A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- area
- region
- interest
- border
- sub
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/08—Clinical applications
- A61B8/0891—Clinical applications for diagnosis of blood vessels
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/46—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
- A61B8/461—Displaying means of special interest
- A61B8/463—Displaying means of special interest characterised by displaying multiple images or images and diagnostic data on one display
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/46—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
- A61B8/467—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient characterised by special input means
- A61B8/469—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient characterised by special input means for selection of a region of interest
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/5215—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data
- A61B8/5223—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for extracting a diagnostic or physiological parameter from medical diagnostic data
Definitions
- the present disclosure relates generally to intravascular imaging using an intravascular imaging catheter and, in particular, to generating a computer-identified border of a region of interest (e.g., blood vessel lumen border) in the intravascular image in response to a user identification of a location inside the region of the interest (e.g., inside the blood vessel lumen).
- a region of interest e.g., blood vessel lumen border
- Intravascular ultrasound (IVUS) imaging is widely used in interventional cardiology as a diagnostic tool for assessing a diseased vessel, such as an artery, within the human body to determine the need for treatment, to guide the intervention, and/or to assess its effectiveness.
- An IVUS device including one or more ultrasound transducers is passed into the vessel and guided to the area to be imaged.
- the transducers emit ultrasonic energy in order to create an image of the vessel of interest.
- Ultrasonic waves are partially reflected by discontinuities arising from tissue structures (such as the various layers of the vessel wall), red blood cells, and other features of interest. Echoes from the reflected waves are received by the transducer and passed along to an IVUS imaging system.
- the imaging system processes the received ultrasound echoes to produce a cross-sectional image of the vessel where the device is placed.
- Peripheral vascular procedures such as angioplasty and stenting in peripheral venous (Inferior Vena Cava - IVC, iliac, femoral veins), IVC-filter retrieval, endovascular aneurism repair (EVAR) and fenestrated endovascular aortic repair (FEVAR) procedures (and similar on the abdominal trait), atherectomy and thrombectomy are procedures where IVUS is used.
- Different diseases or medical procedures produce physical features with different size, structure, density, water content, and accessibility for imaging sensors.
- a stent is a dense (e.g., metallic) object that may be placed in a vessel or lumen to hold the vessel or lumen open to a particular diameter.
- a compression occurs when anatomical structures outside the vessel or lumen impinge on the vessel or lumen, constricting it.
- Pre-treatment decisions such as whether and where to place a stent, may depend on accurate measurements of the vessel lumen area (and/or other anatomical measurements) across a range of locations within the vessel, made during the procedure itself.
- posttreatment decisions such as whether a stent has been accurately placed and dilated, whether additional stents are needed, etc., also rely on accurate measurements made during the procedure.
- the physician himself/herself may choose to step out of the sterile area, or do the measurement within the sterile area with a protective sheet over the device.
- Deep venous anatomy can also be quite complex, and not all features are visible to the naked eye - users often change image settings like brightness, contrast, and gamma (sharpness) to enable better interpretation.
- image settings like brightness, contrast, and gamma (sharpness) to enable better interpretation.
- a clinician, or a technician assisting the clinician may be under considerable pressure to take measurements quickly and efficiently.
- a context- sensitive intravascular measurement system which enables a user to request automated border detection and measurement of particular anatomy, either on individual tomographic images, or along an entire region of an image longitudinal display (ILD).
- the context-sensitive intravascular measurement system also enables the user to request automated correction of a previous anatomical border, or to auto-complete a partial outline drawn manually by the clinician, in order to ensure that the computer-generated border is correct.
- a system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions.
- One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.
- One general aspect includes an apparatus including a processor circuit configured for communication with an intravascular imaging catheter.
- the processor circuit is further configured to: output, to a display in communication with the processor circuit, a first screen display may include an intravascular image obtained by the intravascular imaging catheter, where the intravascular image may include a blood vessel lumen and blood vessel tissue; receive, on the intravascular image, a single user input identifying a location inside of a region of interest, automatically determine, in response to the single user input, a border of the region of interest, where the border surrounds the location identified by the single user input; and output, to the display, a second screen display may include the intravascular image and the border of the region of interest overlaid on the intravascular image.
- 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 methods.
- Implementations may include one or more of the following features.
- the display may include a touchscreen display, where the single user input may include a single touch or click on the intravascular image at the location inside of the region of interest.
- the processor circuit is configured to: determine an area of the region of interest within the intravascular image; and generate the border to surround the area of the region of interest.
- the processor circuit is further configured to associate the location identified by the single user input with a first sub-area of the intravascular image, where, to automatically determine the border of the region of interest, the processor circuit is configured to: identify a second sub-area proximate to the first sub-area; include the second sub-area as part of the area of the region of interest or as part of the border of the region of interest based on a comparison between a parameter of the first sub-area and the parameter of the second sub-area.
- the first sub-area and the second sub-area each may include a pixel or a plurality of pixels of the intravascular image.
- the processor circuit is configured to: include the second sub-area as part of the area of the region of interest when the comparison indicates that the parameter of the second sub-area matches the parameter of the first sub-area; and include the second sub-area as part of the border of the region of interest when the comparison indicates that the parameter of the second sub-area does not match the parameter of the first sub-area.
- the processor is configured to include the first sub-area as part of the area of the region of interest.
- the second sub-area is in contact with the first sub-area.
- the processor circuit is configured to: identify an additional sub-area proximate to the first sub-area; and include the additional sub-area as part of the area of the region of interest or as part of the border of the region of interest, where the processor circuit is configured to iteratively identify the additional sub-area and include the additional sub-area for each of a plurality of additional sub-areas.
- the plurality of sub-areas increases in distance from first sub-area.
- the processor circuit is configured to end iterating when the border of the region of interest completely encloses the first sub-area.
- the first screen display does not include an initial border overlaid on the intravascular image such that the border of the region of interest is added to the intravascular image in the second screen display.
- the first screen display may include an initial border overlaid on the intravascular image such that the border of the region of interest in the second screen display may include a change to the initial border.
- the change may include making an area of the region of interest indicated by the border of the region of interest in the second screen display smaller than the area of the region of interest indicated by the initial border in the first screen display.
- Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.
- One general aspect includes an apparatus including a processor circuit configured for communication with an intravascular imaging catheter.
- the processor circuit is configured to: output, to a display in communication with the processor circuit, a first screen display may include an intravascular image obtained by the intravascular imaging catheter, where the intravascular image may include a blood vessel lumen and blood vessel tissue; receive, on the intravascular image, a user input drawing only a first portion of a border of a region of interest, automatically determine, in response to the user input, a second portion of the border of the region of interest such that the first portion and the second portion together define an entirety of the border of the region of interest; output, to the display, a second screen display may include the intravascular image and the border of the region of interest overlaid on the intravascular image.
- 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 methods.
- Implementations may include one or more of the following features.
- the display may include a touchscreen display, where the user input drawing only the first portion may include a touch and drag input on the intravascular image along the border of the region of interest.
- the processor circuit is configured to: determine a first parameter on a first side of the first portion of the first portion of the border of the region of interest; determine a second parameter on an opposite, second side of the first portion of the first portion of the border of the region of interest; determine a relationship between the first parameter and the second parameter; and generate the second portion of the border of the region of interest to maintain the relationship along the second portion of the border of the region of interest.
- Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.
- One general aspect includes an apparatus that includes a processor circuit configured for communication with an intravascular imaging catheter.
- the processor circuit is configured to: output, to a display in communication with the processor circuit, a first screen display may include a longitudinal cross-sectional image of a blood vessel, where the longitudinal cross-sectional image is generated based on a plurality of radial cross-sectional images of the blood vessel obtained by the intravascular imaging catheter, where the longitudinal cross-sectional image of the vessel may include a blood vessel lumen and blood vessel tissue; receive, on the longitudinal cross-sectional image, a user input identifying a region inside of a region of interest, automatically determine, in response to the user input, a border of the region of interest in a subset of the plurality cross-sectional images associated with the region identified by the user input on the longitudinal cross-sectional image; output, to the display, a second screen display that may include: the longitudinal cross-sectional image; a radial cross-sectional image of the subset; and the border of the region of interest overl
- Implementations may include one or more of the following features.
- the display may include a touchscreen display, where the user input identifying the region may include a touch and drag input or click and drag input on the intravascular image inside of the blood vessel lumen.
- the processor circuit is configured to, for each radial cross-sectional image of the subset: associate a portion of the region identified by the user input with a corresponding radial cross- sectional image; map the portion of the region identified by the user input to a first sub-area inside of the region of interest; include the first sub-area as part of the area of the region of interest; identify an additional sub-area proximate to the first sub-area; include the additional sub-area as part of the area of the region of interest or as part of the border of the region of interest, where the processor circuit is configured to iteratively identify the additional sub-area and include the additional sub-area for each of a plurality of additional sub-areas.
- Figure l is a diagrammatic schematic view of an intraluminal imaging system, according to aspects of the present disclosure.
- Figure 2 illustrates blood vessels (e.g., arteries and veins) in the human body.
- blood vessels e.g., arteries and veins
- Figure 3 illustrates a blood vessel incorporating a compression.
- Figure 5 is a schematic diagram of a processor circuit, according to embodiments of the present disclosure.
- Figure 6 is a screen display showing an IVUS image, an image longitudinal display (ILD), and a selection tool or add tool, according to aspects of the present disclosure.
- ILD image longitudinal display
- Figure 7 is a screen display showing the automatically identified lumen boundary of the lumen in the IVUS image, according to aspects of the present disclosure.
- Figure 8 is a schematic, diagrammatic view, in flow diagram form, of an example measurement area adding method, according to aspects of the present disclosure.
- Figure 9 is a schematic, diagrammatic view, in flow diagram form, of an example univariate comparison step or, according to aspects of the present disclosure.
- Figure 10A is a schematic, diagrammatic view, in flow diagram form, of an example multivariate comparison step or, according to aspects of the present disclosure.
- Figure 10B is a schematic, diagrammatic view, in flow diagram form, of an example multivariate comparison and identification method, according to aspects of the present disclosure.
- Figure 11 is a grid showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- Figure 12 is a grid showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- Figure 13 is a grid showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- Figure 14 is a grid showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- Figure 15 is a grid showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- Figure 16 is a grid showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- Figure 17 is a grid showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- Figure 18 is a grid showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- Figure 19 is a screen display showing an IVUS image, an image longitudinal display (ILD), and a de-selection tool or subtraction tool, according to aspects of the present disclosure.
- Figure 20 is a screen display showing the automatically identified lumen boundary of the lumen in the IVUS image, according to aspects of the present disclosure.
- Figure 21 is a schematic, diagrammatic view, in flow diagram form, of an example lumen area subtraction method, according to aspects of the present disclosure.
- Figure 22 is a grid showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- Figure 23 is a grid showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- Figure 24 is a screen display showing an IVUS image, an image longitudinal display (ILD), and a drawing tool, according to aspects of the present disclosure.
- ILD image longitudinal display
- Figure 25 is a screen display showing an IVUS image, an image longitudinal display (ILD), and an automatically completed lumen boundary drawing, according to aspects of the present disclosure.
- ILD image longitudinal display
- Figure 26A is a schematic, diagrammatic view, in flow diagram form, of an example lumen boundary autocompletion method, according to aspects of the present disclosure.
- Figure 26B is a schematic, diagrammatic view, in flow diagram form, of an example lumen boundary autocompletion method, according to aspects of the present disclosure.
- Figure 27 is a grid showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- Figure 28 is a grid showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- Figure 29 is a screen display showing an IVUS image, an image longitudinal display (ILD), and a selection tool or add tool, according to aspects of the present disclosure.
- ILD image longitudinal display
- Figure 30 is a screen display showing an IVUS image and an image longitudinal display (ILD), according to aspects of the present disclosure.
- ILD image longitudinal display
- Figure 31 is a schematic, diagrammatic view, in flow diagram form, of an example lumen boundary autocompletion method, according to aspects of the present disclosure.
- Embodiments of the present disclosure provide systems, methods, and associated devices that perform automated tasks overcoming one or more of the limitations described above.
- a context-sensitive intravascular measurement system is provided which enables a user to request automated measurement of particular anatomy (e.g., the cross-sectional area of the lumen of a blood vessel or other region of interest), either on individual radial cross-sectional or tomographic (e.g., intravascular ultrasound (IVUS) or optical coherence tomography (OCT)) images, or along an entire region of an image longitudinal display (ILD).
- IVUS intravascular ultrasound
- OCT optical coherence tomography
- the context-sensitive intravascular measurement system also enables the user to request automated correction of a previous anatomical measurement, or to auto-complete a partial outline drawn manually by the clinician (e.g., with a mouse, trackball, touchscreen, etc.).
- the context-sensitive intravascular measurement system combines an easy-to-use tool with an Al /Deep Learning capability that allows automatic selection of regions to compute area statistics based on intravascular images of an anatomical region in the deep venous space. Numerous factors contribute to the variability in measurements produced on intraluminal or intravascular imaging systems, even by the same clinician on the same image.
- the context- sensitive intravascular measurement system provides an easy way of making these corrections or even starting a measurement from scratch with minimum user interaction. This will also help users toward getting to a clinical diagnosis faster and with less variation, which can drive down costs, improve throughput, and improve outcomes.
- Quick Selection tools are available in commercial image editing software, but are not configured to interpret IVUS or OCT images, are not sensitive to variables such as depth, texture, frequency spectrum, spatial frequency, texture, or virtual histology, and are not configured for use on the computing systems commonly used in an operating room or catheter lab. Additional challenges overcome by the context-sensitive intravascular measurement system include usability and time. Also, the context-sensitive intravascular measurement system is scalable with improvements to the IVUS image by retraining, and is relatively insensitive to factors such as catheter-to-catheter variation that would otherwise contribute to measurement variability.
- the main elements of the context-sensitive intravascular measurement tool include: [0054] A user interface (UI) capable of touch input or click input on an IVUS or other radial cross-sectional or tomographic image (e.g., intravascular OCT image). This may include the ability to drag a finger or mouse across a single tomographic image, or across a series of images in a longitudinal view (e.g., a longitudinal cross-sectional image or an image longitudinal display (ILD)).
- UI user interface
- An image analysis component that analyzes the underlying raw image data for spectral characteristics or performs pattern recognition using deep learning.
- the context-sensitive intravascular measurement system is a software tool that can be integrated into existing intravascular or intraluminal imaging systems through a software update, or can be included in new systems.
- the devices, systems, and methods described herein can include one or more features described in U.S. Provisional App. No. 62/750,983, filed 26 October 2018, U.S. Provisional App. No. 62/751,268, filed 26 October 2018, U.S. Provisional App. No. 62/751,289, filed 26 October 2018, U.S. Provisional App. No. 62/750,996, filed 26 October 2018, U.S. Provisional App. No. 62/751,167, filed 26 October 2018, and U.S. Provisional App. No. 62/751,185, filed 26 October 2018, each of which is hereby incorporated by reference in its entirety as though fully set forth herein.
- the devices, systems, and methods described herein can also include one or more features described in U.S. Provisional App. No. 62/642,847, filed March 14, 2018, U.S. Provisional App. No. 62/712,009, filed July 30, 2018, U.S. Provisional App. No. 62/711,927, filed July 30, 2018, and U.S. Provisional App. No. 62/643,366, filed March 15, 2018, each of which is hereby incorporated by reference in its entirety as though fully set forth herein.
- the context-sensitive intravascular measurement system has particular but not exclusive utility for measurement of blood vessel lumen diameters before and after placement and dilation of a stent in occluded regions.
- the present disclosure aids substantially in the measurement of anatomy, by improving the speed, accuracy, and repeatability with which such measurements can be obtained.
- a digital IVUS catheter or digital IVUS guidewire in communication with a processor such as a patient interface module (PIM) and/or IVUS imaging console, the context- sensitive intravascular measurement system disclosed herein provides practical improvements in the treatment of vascular diseases.
- This improved anatomical measurement technique transforms a largely manual process that is dependent on expertise and dexterity into one that can be performed repeatably at high speed, without the normally routine need for extensive training of clinicians.
- This unconventional approach improves the functioning of the ultrasound imaging system, by streamlining the process by which anatomical measurements are taken.
- the context-sensitive intravascular measurement system may be implemented as a process at least partially viewable on a display, and operated by a control process executing on a processor that accepts user inputs from a keyboard, mouse, touchscreen interface, or other user interface, and that is in communication with one or more ultrasound transducers.
- the control process performs certain specific operations in response to different inputs or selections made at different times.
- Certain outputs of the context-sensitive intravascular measurement system may be printed, shown on a display, or otherwise communicated to human operators.
- FIG. l is a diagrammatic schematic view of an intraluminal imaging system, according to aspects of the present disclosure.
- the intraluminal imaging system 100 can be an intravascular ultrasound (IVUS) imaging system in some embodiments.
- the intraluminal imaging system 100 may include an intraluminal device 102, a patient interface module (PIM) 104, a console or processing system 106, a monitor 108, and an external imaging system 132 which may include angiography, ultrasound, X-ray, computed tomography (CT), magnetic resonance imaging (MRI), or other imaging technologies, equipment, and methods.
- the intraluminal device 102 is sized and shaped, and/or otherwise structurally arranged to be positioned within a body lumen of a patient.
- the intraluminal device 102 can be a catheter, guide wire, guide catheter, pressure wire, and/or flow wire in various embodiments.
- the system 100 may include additional elements and/or may be implemented without one or more of the elements illustrated in Figure 1.
- the system 100 may omit the external imaging system 132.
- the intraluminal imaging system 100 can be any type of imaging system suitable for use in the lumens or vasculature of a patient.
- the intraluminal imaging system 100 is an intravascular ultrasound (IVUS) imaging system.
- the intraluminal imaging system 100 may include systems configured for forward looking intravascular ultrasound (FL-IVUS) imaging, intravascular photoacoustic (IVPA) imaging, intracardiac echocardiography (ICE), transesophageal echocardiography (TEE), and/or other suitable imaging modalities.
- the system 100 and/or device 102 can be configured to obtain any suitable intraluminal imaging data.
- the device 102 may include an imaging component of any suitable imaging modality, such as optical imaging, optical coherence tomography (OCT), etc.
- the device 102 may include any suitable nonimaging component, including a pressure sensor, a flow sensor, a temperature sensor, an optical fiber, a reflector, a mirror, a prism, an ablation element, a radio frequency (RF) electrode, a conductor, or combinations thereof.
- the device 102 can include an imaging element to obtain intraluminal imaging data associated with the lumen 120.
- the device 102 may be sized and shaped (and/or configured) for insertion into a vessel or lumen 120 of the patient.
- the system 100 may be deployed in a catheterization laboratory having a control room.
- the processing system 106 may be located in the control room.
- the processing system 106 may be located elsewhere, such as in the catheterization laboratory itself.
- the catheterization laboratory may include a sterile field while its associated control room may or may not be sterile depending on the procedure to be performed and/or on the health care facility.
- the catheterization laboratory and control room may be 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, a fractional flow reserve (FFR) determination, a 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.
- device 102 may be controlled from a remote location such as the control room, such than an operator is not required to be in close proximity to the patient.
- the intraluminal device 102, PIM 104, monitor 108, and external imaging system 132 may be communicatively coupled directly or indirectly to the processing system 106. These elements may be communicatively coupled to the medical processing system 106 via a wired connection such as a standard copper link or a fiber optic link and/or via wireless connections using IEEE 802.11 Wi-Fi standards, Ultra Wide-Band (UWB) standards, wireless FireWire, wireless USB, or another high-speed wireless networking standard.
- the processing system 106 may be communicatively coupled to one or more data networks, e.g., a TCP/IP -based local area network (LAN). In other embodiments, different protocols may be utilized such as Synchronous Optical Networking (SONET).
- SONET Synchronous Optical Networking
- the processing system 106 may be communicatively coupled to a wide area network (WAN).
- the processing system 106 may utilize network connectivity to access various resources.
- 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 (HIS) via a network connection.
- DICOM Digital Imaging and Communications in Medicine
- PES Picture Archiving and Communication System
- HIS Hospital Information System
- an ultrasound imaging intraluminal device 102 emits ultrasonic energy from a transducer array 124 included in scanner assembly 110 mounted near a distal end of the intraluminal device 102.
- the ultrasonic energy is reflected by tissue structures in the medium (such as a lumen 120) surrounding the scanner assembly 110, and the ultrasound echo signals are received by the transducer array 124.
- the scanner assembly 110 generates electrical signal(s) representative of the ultrasound echoes.
- the scanner assembly 110 can include one or more single ultrasound transducers and/or a transducer array 124 in any suitable configuration, such as a planar array, a curved array, a circumferential array, an annular array, etc.
- the scanner assembly 110 can be a one-dimensional array or a two-dimensional array in some instances.
- the scanner assembly 110 can be a rotational ultrasound device.
- the active area of the scanner assembly 110 can include one or more transducer materials and/or one or more segments of ultrasound elements (e.g., one or more rows, one or more columns, and/or one or more orientations) that can be uniformly or independently controlled and activated.
- the active area of the scanner assembly 110 can be patterned or structured in various basic or complex geometries.
- the scanner assembly 110 can be disposed in a side-looking orientation (e.g., ultrasonic energy emitted perpendicular and/or orthogonal to the longitudinal axis of the intraluminal device 102) and/or a forward-looking looking orientation (e.g., ultrasonic energy emitted parallel to and/or along the longitudinal axis).
- the scanner assembly 110 is structurally arranged to emit and/or receive ultrasonic energy at an oblique angle relative to the longitudinal axis, in a proximal or distal direction.
- ultrasonic energy emission can be electronically steered by selective triggering of one or more transducer elements of the scanner assembly 110.
- the ultrasound transducer(s) of the scanner assembly 110 can be a piezoelectric micromachined ultrasound transducer (PMUT), capacitive micromachined ultrasonic transducer (CMUT), single crystal, lead zirconate titanate (PZT), PZT composite, other suitable transducer type, and/or combinations thereof.
- PMUT piezoelectric micromachined ultrasound transducer
- CMUT capacitive micromachined ultrasonic transducer
- PZT lead zirconate titanate
- PZT composite other suitable transducer type, and/or combinations thereof.
- the ultrasound transducer array 124 can include any suitable number of individual transducer elements or acoustic elements between 1 acoustic element and 1000 acoustic elements, including values such as 2 acoustic elements, 4 acoustic elements, 36 acoustic elements, 64 acoustic elements, 128 acoustic elements, 500 acoustic elements, 812 acoustic elements, and/or other values both larger and smaller.
- the PIM 104 transfers the received echo signals to the processing system 106 where the ultrasound image (including the flow information) is reconstructed and displayed on the monitor 108.
- the console or processing system 106 can include a processor and a memory.
- the processing system 106 may be operable to facilitate the features of the intraluminal imaging system 100 described herein.
- the processor can execute computer readable instructions stored on the non-transitory tangible computer readable medium.
- the PIM 104 facilitates communication of signals between the processing system 106 and the scanner assembly 110 included in the intraluminal device 102. This communication may include providing commands to integrated circuit controller chip(s) within the intraluminal device 102, selecting particular element(s) on the transducer array 124 to be used for transmit and receive, providing the transmit trigger signals to the integrated circuit controller chip(s) to activate the transmitter circuitry to generate an electrical pulse 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 preliminary processing of the echo data prior to relaying the data to the processing system 106.
- the PIM 104 performs amplification, filtering, and/or aggregating of the data. In an embodiment, the PIM 104 also supplies high- and low-voltage DC power to support operation of the intraluminal device 102 including circuitry within the scanner assembly 110.
- the processing system 106 receives echo data from the scanner assembly 110 by way of the PIM 104 and processes the data to reconstruct an image of the tissue structures in the medium surrounding the scanner assembly 110.
- the device 102 can be utilized within any suitable anatomy and/or body lumen of the patient.
- the processing system 106 outputs image data such that an image of the vessel or lumen 120, such as a cross-sectional IVUS image of the lumen 120, is displayed on the monitor 108.
- Lumen 120 may represent fluid filled or fluid-surrounded structures, both natural and man-made. Lumen 120 may be within a body of a patient.
- Lumen 120 may be a blood vessel, such as an artery or a vein of a patient’s vascular system, including cardiac vasculature, peripheral vasculature, neural vasculature, renal vasculature, and/or or any other suitable lumen inside the body.
- the device 102 may be used to examine any number of anatomical locations and tissue types, including without limitation, organs including the liver, heart, kidneys, gall bladder, pancreas, lungs; ducts; intestines; nervous system structures including the brain, dural sac, spinal cord and peripheral nerves; the urinary tract; as well as valves within the blood, chambers or other parts of the heart, and/or other systems of the body.
- the device 102 may be used to examine man-made structures such as, but without limitation, heart valves, stents, shunts, filters and other devices.
- the controller or processing system 106 may include a processing circuit having one or more processors in communication with memory and/or other suitable tangible computer readable storage media.
- the controller or processing system 106 may be configured to carry out one or more aspects of the present disclosure.
- the processing system 106 and the monitor 108 are separate components.
- the processing system 106 and the monitor 108 are integrated in a single component.
- the system 100 can include a touch screen device, including a housing having a touch screen display and a processor.
- the system 100 can include any suitable input device, such as a touch sensitive pad or touch screen display, keyboard/mouse, joystick, button, etc., for a user to select options shown on the monitor 108.
- the processing system 106, the monitor 108, the input device, and/or combinations thereof can be referenced as a controller of the system 100.
- the controller can be in communication with the device 102, the PIM 104, the processing system 106, the monitor 108, the input device, and/or other components of the system 100.
- the intraluminal device 102 includes some features similar to traditional solid-state IVUS catheters, such those disclosed in U.S. Patent No. 7,846,101, hereby incorporated by reference in its entirety.
- the intraluminal device 102 may include the scanner assembly 110 near a distal end of the intraluminal device 102 and a transmission line bundle 112 extending along the longitudinal body of the intraluminal device 102.
- the cable or transmission line bundle 112 can include a plurality of conductors, including one, two, three, four, five, six, seven, or more conductors.
- the transmission line bundle 112 terminates in a PIM connector 114 at a proximal end of the intraluminal device 102.
- the PIM connector 114 electrically couples the transmission line bundle 112 to the PIM 104 and physically couples the intraluminal device 102 to the PIM 104.
- the intraluminal device 102 further includes a guidewire exit port 116. Accordingly, in some instances the intraluminal device 102 is a rapid-exchange catheter.
- the guidewire exit port 116 allows a guidewire 118 to be inserted towards the distal end in order to direct the intraluminal device 102 through the lumen 120.
- the monitor 108 may be a display device such as a computer monitor or other type of screen.
- the monitor 108 may be used to display selectable prompts, instructions, and visualizations of imaging data to a user.
- the monitor 108 may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure. This workflow may include performing a pre-stent plan to determine the state of a lumen and potential for a stent, as well as a post-stent inspection to determine the status of a stent that has been positioned in a lumen.
- the external imaging system 132 can be configured to obtain x-ray, radiographic, angiographic/venographic (e.g., with contrast), and/or fluoroscopic (e.g., without contrast) images of the body of a patient (including the vessel 120). External imaging system 132 may also be configured to obtain computed tomography images of the body of the patient (including the vessel 120).
- the external imaging system 132 may include an external ultrasound probe configured to obtain ultrasound images of the body of the patient (including the vessel 120) while positioned outside the body.
- the system 100 includes other imaging modality systems (e.g., MRI) to obtain images of the body of the patient (including the vessel 120).
- the processing system 106 can utilize the images of the body of the patient in conjunction with the intraluminal images obtained by the intraluminal device 102.
- Figure 2 illustrates blood vessels (e.g., arteries and veins) in the human body.
- blood vessels e.g., arteries and veins
- veins of the human body are labeled.
- aspects of the present disclosure can be related to peripheral vasculature, e.g., veins in the torso or legs.
- Occlusions can occur in arteries or veins.
- An occlusion can be generally representative of any blockage or other structural arrangement that results in a restriction to the flow of fluid through the lumen (e.g., an artery or a vein), for example, in a manner that is deleterious to the health of the patient.
- the 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 decreased.
- the occlusion may be a result of narrowing due to compression (e.g.
- the occlusion can be referenced as thrombus, a stenosis, and/or a lesion.
- the composition of the occlusion will depend on the type of anatomy being evaluated. Healthier portions of the anatomy may have a uniform or symmetrical profile (e.g., a cylindrical profile with a circular cross-sectional profile). The occlusion may not have a uniform or symmetrical profile. Accordingly, diseased or compressed portions of the anatomy, with the occlusion, will have a non-symmetric and/or otherwise irregular profile.
- the anatomy can have one occlusion or multiple occlusions.
- occlusion e.g., thrombus, deep vein thrombosis or DVT, chronic total occlusion or CTO, etc.
- the cross-sectional area of the vein in the peripheral vasculature e.g., torso, abdomen, groin, leg
- Other anatomy that contacts the vein can also reduce its cross-sectional area, thereby restricting blood flow therethrough.
- arteries or ligaments in the torso, abdomen, groin, or leg can press against a vein, which changes the shape of the vein and reduces its cross-sectional area.
- FIG. 3 illustrates a blood vessel 300 incorporating a compression 330.
- the compression 330 occurs outside the vessel walls 310 and may restrict the flow of blood 320.
- the compression may be caused by other anatomical structures outside the blood vessel 300, including but not limited to a tendon, ligament, or neighboring lumen.
- Figure 4 illustrates a blood vessel 300 incorporating a compression 330 and with a stent 440 expanded inside it to restore flow.
- the stent 440 displaces and arrests the compression 330, pushing the vessel walls 310 outward, thus reducing the flow restriction for the blood 320.
- Other treatment options for alleviating an occlusion may include but are not limited to thrombectomy, ablation, angioplasty, and pharmaceuticals. However, in a large majority of cases it may be 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 prior to, during, or after treatment.
- FIG. 5 is a schematic diagram of a processor circuit 550, according to aspects of the present disclosure.
- the processor circuit 550 may be implemented in the intraluminal imaging system 100, or other devices or workstations (e.g., third-party workstations, network routers, etc.), or on a cloud processor or other remote processing unit, as necessary to implement the method.
- the processor circuit 550 may include a processor 560, a memory 564, and a communication module 568. These elements may be in direct or indirect communication with each other, for example via one or more buses.
- the processor 560 may include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, or any combination of general-purpose computing devices, reduced instruction set computing (RISC) devices, application-specific integrated circuits (ASICs), field programmable gate arrays (FPGAs), or other related logic devices, including mechanical and quantum computers.
- the processor 560 may also comprise another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein.
- the processor 560 may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.
- the memory 564 may include a cache memory (e.g., a cache memory of the processor 560), 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 device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory.
- the memory 564 includes a non-transitory computer-readable medium.
- the memory 564 may store instructions 566.
- the instructions 566 may include instructions that, when executed by the processor 560, cause the processor 560 to perform the operations described herein.
- Instructions 566 may also be referred to as code.
- the terms “instructions” and “code” should be interpreted broadly to include any type of computer-readable statement(s).
- the terms “instructions” and “code” may refer to one or more programs, routines, sub-routines, functions, procedures, etc.
- “Instructions” and “code” may include a single computer-readable statement or many computer- readable statements.
- the communication module 568 can include any electronic circuitry and/or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 550, and other processors or devices.
- the communication module 568 can be an input/output (VO) device.
- the communication module 568 facilitates direct or indirect communication between various elements of the processor circuit 550 and/or the intraluminal imaging system 100.
- the communication module 568 may communicate within the processor circuit 550 through numerous methods or protocols.
- Serial communication protocols may include but are not limited to United States Serial Protocol Interface (US SPI), Inter- Integrated Circuit (I 2 C), Recommended Standard 232 (RS-232), RS-485, Controller Area Network (CAN), Ethernet, Aeronautical Radio, Incorporated 429 (ARINC 429), MODBUS, Military Standard 1553 (MIL-STD-1553), or any other suitable method or protocol.
- Parallel protocols include but are not limited to Industry Standard Architecture (ISA), Advanced Technology Attachment (ATA), Small Computer System Interface (SCSI), Peripheral Component Interconnect (PCI), Institute of Electrical and Electronics Engineers 488 (IEEE-488), IEEE-1284, and other suitable protocols. Where appropriate, serial and parallel communications may be bridged by a Universal Asynchronous Receiver Transmitter (UART), Universal Synchronous Receiver Transmitter (USART), or other appropriate subsystem.
- External communication may be accomplished using any suitable wireless or wired communication technology, such as a cable interface such as a universal serial bus (USB), micro USB, Lightning, or FireWire interface, Bluetooth, Wi-Fi, ZigBee, Li-Fi, or cellular data connections such as 2G/GSM (global system for mobiles) , 3G/UMTS (universal mobile telecommunications system), 4G, long term evolution (LTE), WiMax, or 5G.
- a Bluetooth Low Energy (BLE) radio can be used to establish connectivity with a cloud service, for transmission of data, and for receipt of software patches.
- BLE Bluetooth Low Energy
- 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 on physical media such as a USB flash drive or memory stick.
- one or more of the steps of the methods described above can be performed by one or more components of an ultrasound imaging system, such as the processing system, a multiplexer, a beamformer, a signal processing unit, an image processing unit, or any other suitable component of the system.
- activating the scan sequences may be carried out by a processor in communication with a multiplexer configured to select or activate one or more elements of an ultrasound transducer array.
- generating the ultrasound images may include beamforming incoming signals from the ultrasound imaging device and processing the beamformed signals by an image processor.
- the processing components of the system can be integrated within the ultrasound imaging device, contained within an external console, or may be a separate component.
- Figure 6 is a screen display 600 showing an IVUS image 610, an image longitudinal display (ILD) 620, and a selection tool or add tool 650, according to aspects of the present disclosure. Visible in the IVUS image 610 and the ILD 620 are a first vessel lumen 630a and a second vessel lumen 630b. A position indicator 640 shows the position of the current IVUS image frame 610 within the ILD 620. In an example, the user uses a mouse, trackball, touchscreen, etc., to move the selection tool or add tool 650 to the desired anatomical feature to be measured. In the example shown in Figure 6, this is the second vessel lumen 630b.
- the border 710 of the blood vessel lumen 630b may be automatically determined in response to the user input without a separate user input directing the processor circuit to determine the border.
- the present disclosure uses a vessel lumen as an example anatomical region of interest for selection and measurement (e.g., the vessel lumen is differentiated from vessel tissue surrounding/defining the vessel lumen).
- the vessel lumen is differentiated from vessel tissue surrounding/defining the vessel lumen.
- other anatomy can be selected with the add tool besides vessel lumens, including without limitation vessel walls, occlusions (e.g., clots, webbing, calcifications, stenoses, compressions, etc.), side branches, tumors and other anomalies, neighboring anatomy, and/or other regions of interest.
- aspects of the present disclosure apply to any adjacent pair of anatomical regions of interest that need to be differentiated.
- Figure 7 is a screen display 700 showing the automatically identified lumen boundary 710 of the lumen 630b in the IVUS image 610, according to aspects of the present disclosure. Visible are the first lumen 630a, second lumen 630b, and position indicator 640.
- the context-sensitive intravascular measurement system automatically detects or generates the lumen boundary 710 and measurements 720.
- the measurements 720 may for example include the area (e.g., in square microns), eccentricity, semi-major and semi-minor axis (also known as minimum and maximum diameter), average diameter, and/or other geometric parameters as needed. Also visible is a frame number 730 and total number of frames 740.
- the screen display 700 is an update to the screen display 600, and may be the same as the screen display 600 except that it is updated to additionally include the border of the blood vessel lumen as an overlay, where the identified border completely encloses or surrounds the location identified by the user input.
- Figure 8 is a schematic, diagrammatic view, in flow diagram form, of an example measurement area adding method 800, according to aspects of the present disclosure. It is understood that the steps of method 800 may be performed in a different order than shown in Figure 8, additional steps can be provided before, during, and after the steps, and/or some of the steps described can be replaced or eliminated in other embodiments. One or more of steps of the method 800 can be carried by one or more devices and/or systems described herein, such as components of the system 100, processing system 106, and/or processor circuit 550.
- the method 800 includes, from a screen display 805 containing a vascular image, receiving a user input inside the vessel lumen of interest.
- the location where the user clicked identified an input sub-area within the vessel lumen.
- a sub-area may be a single pixel or a group of pixels of configurable or non-configurable size. Execution then proceeds to step 815.
- the method 800 includes determining the image parameters of the input sub-area.
- these parameters may include one or more of the brightness, contrast, and/or depth of the pixels in the sub-area, or may include complex or derived properties such as frequency spectrum, spatial frequency, or texture/smoothness (e.g., a degree of variation between neighboring pixels or sub-regions). Execution then proceeds to step 820.
- the method 800 includes comparing the parameters of the input-sub area to the pre-determined parameters for a blood vessel lumen.
- a blood vessel lumen may be expected to return weak echoes and thus be black or dark gray in an ultrasound image, with little variability, whereas a blood vessel wall may be relatively much brighter and more variable. Execution then proceeds to step 825.
- step 825 the method 800 includes determining whether the parameters of the input sub-area match the pre-determined parameters for the lumen area. If yes, execution then proceeds to step 830. If no, execution then proceeds to step 828.
- step 828 the method 800 includes outputting a prompt, requesting a new user input (e.g., a touchscreen input, mousejoystick, or trackball input, keyboard input, etc.) that is located within the vessel lumen. Execution then returns to step 810.
- a new user input e.g., a touchscreen input, mousejoystick, or trackball input, keyboard input, etc.
- the method 800 includes determining that the input sub-area is part of the lumen area. Execution then proceeds to step 835.
- step 835 the method 800 includes identifying sub-areas that are adjacent to the input sub-area. Execution then proceeds to step 840.
- step 840 the method 800 includes determining the image parameters (e.g., brightness, contrast, depth, frequency spectrum, spatial frequency, texture/smoothness, etc.) of the adjacent sub-areas. Execution then proceeds to step 845.
- image parameters e.g., brightness, contrast, depth, frequency spectrum, spatial frequency, texture/smoothness, etc.
- step 845 the method 800 includes comparing the image parameters of the adjacent sub-areas to the pre-determined parameters of the lumen area and/or to the parameters of the input sub-area. Execution then proceeds to step 850.
- step 850 the method 800 includes determining whether the parameters for the neighboring sub-areas match the parameters for the lumen. If yes, execution then proceeds to step 855. If no, execution then proceeds to step 860.
- step 855 the method 800 includes adding the adjacent sub-areas with matching parameters as part of the identified lumen area. Execution then proceeds to step 865.
- step 860 the method 800 includes adding the adjacent sub-areas with nonmatching parameters as part of the identified lumen border. Execution then proceeds to step 865.
- step 865 the method 800 includes determining whether steps 850-860 identified at least one match to the lumen area. If yes, then the lumen area is not fully enclosed by boundary sub-areas, and execution then returns to step 835. If no, the lumen area is fully enclosed by boundary sub-areas, and will not grow if additional adjacent sub-areas are examined, and execution then proceeds to step 870.
- step 875 the method 800 includes generating and outputting a screen display with the lumen border overlaid on the IVUS image, and/or including the calculated dimensions.
- steps 830-865 are determining the lumen border and/or the lumen area.
- the method 800 is described with respect to measurement of a vessel lumen, the same method can be applied to identifying and/or measuring a vessel wall, a stent, a clot or plaque, etc.
- flow diagrams are provided herein for exemplary purposes; a person of ordinary skill in the art will recognize myriad variations that nonetheless fall within the scope of the present disclosure. For example, the logic of flow diagrams may be shown as sequential.
- a processor may divide each of the steps described herein into a plurality of machine instructions, and may execute these instructions at the rate of several hundred, several thousand, several million, or several billion per second, in a single processor or across a plurality of processors. Such rapid execution may be necessary in order to execute the method in real time or near-real time as described herein. For example, generating a vessel lumen in real time may involve analyzing multiple variables associated with each of hundreds or thousands of different pixels, in a fraction of a second.
- Figure 9 is a schematic, diagrammatic view, in flow diagram form, of an example univariate comparison step 825 or 850, according to aspects of the present disclosure.
- the univariate comparison step 825 or 850 includes determining a difference or degree of separation (e.g., brightness, frequency, etc.) between a parameter of an adjacent sub-area 910 and a parameter of a lumen area 920. Execution then proceeds to step 940.
- a difference or degree of separation e.g., brightness, frequency, etc.
- step 940 the univariate comparison step 825 or 850 includes determining whether the difference or separation falls within a specified threshold. If yes, execution then proceeds to step 950. If no, execution then proceeds to step 970.
- step 950 the adjacent sub-area is a matching sub-area. Execution then proceeds to step 960.
- step 960 the univariate comparison step 825 or 850 includes adding the adjacent sub-area as part of the lumen area.
- the univariate comparison step 825 or 850 is now complete.
- step 970 the adjacent sub-area is a non-matching sub-area (e.g., not part of the lumen).
- step 980 the univariate comparison step 825 or 850 includes adding the adjacent sub-area to the lumen border. The univariate comparison step 825 or 850 is now complete.
- Figure 10A is a schematic, diagrammatic view, in flow diagram form, of an example multivariate comparison step 825 or 850, according to aspects of the present disclosure.
- a trained machine learning (ML) model or neural network receives, as inputs, parameter A for adjacent sub-areas I and II, and the known parameter of the lumen, along with parameter B for adjacent sub-areas I and II, and the known parameter B of the lumen.
- ML machine learning
- the trained ML model determines that adjacent subarea I is a matching sub-area (e.g., part of the lumen).
- step 1050 the matching sub-area is added as part of the lumen area.
- step 1055 the trained ML model determines that adjacent sub-area II is a nonmatching sub-area (e.g., not part of the lumen).
- step 1060 the non-matching sub-area is added as part of the lumen border or vessel wall.
- Figure 10B is a schematic, diagrammatic view, in flow diagram form, of an example multivariate comparison and identification method 1070, according to aspects of the present disclosure.
- a trained machine learning model receives an image frame 1075 containing at least parameter A for each pixel in the frame.
- the ML model may also examine additional parameters (B, C, D, etc.).
- step 1085 the ML model outputs the location of the lumen border and or the lumen area in the image frame.
- step 1090 the system displays the lumen border overlaid on the image frame 1075.
- Figure 13 is a grid 1100 showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- the adjacent sub-areas have all been identified as belonging to the vessel lumen 1310, and have been added to its area.
- Figure 14 is a grid 1100 showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- sixteen sub-areas 1210 have been identified for examination that are adjacent to the currently identified lumen area 1310.
- Figure 15 is a grid 1100 showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- some of the adjacent sub-areas e.g., those with a parameter value of 3 or less
- Other adjacent sub-areas have been added to the vessel wall 1520, such that portions 1530 of the provisional border 1510 now correspond to the actual lumen border.
- Figure 16 is a grid 1100 showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- fifteen sub-areas 1210 have been identified that are adjacent to the currently identified lumen area 1310.
- Figure 17 is a grid 1100 showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- some of the adjacent sub-areas e.g., those with a parameter value of 3 or less
- Other adjacent sub-areas have been added to the vessel wall 1520, such that even larger portions 1530 of the provisional border 1510 now correspond to the actual lumen border.
- Figure 18 is a grid 1100 showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- the entire vessel wall 1520 and lumen area 1310 have been identified, such that the provisional lumen border 1510 now represents the actual lumen border, and can be used for measurement of the lumen area and other parameters.
- this method prevents a second lumen 1810 from being identified as part of the original lumen 1310.
- Figure 19 is a screen display 1900 showing an IVUS image 610, an image longitudinal display (ILD) 620, and a de-selection tool or subtraction tool 1950, according to aspects of the present disclosure. Visible in the IVUS image 610 and the ILD 620 are a first vessel lumen 630a and a second vessel lumen 630b. A position indicator 640 shows the position of the current IVUS image frame 610 within the ILD 620. In the example shown in Figure 19, the lumen border 1610 has been mis-identified, such that it encompasses the first lumen 630a, second lumen 630b, and an anomalous dark region 1620, and results in anomalously large measurements 720.
- Subtraction is not the only change that can be made to the lumen border.
- the add tool 650 (see Figure 6) may be used to add an area to the lumen in a manner similar to the subtraction shown in Figure 19, or corrections may be drawn by hand (see Figures 24-25, below).
- the present disclosure uses vessel lumens as an example anatomical region of interest for selection and measurement (e.g., the vessel lumen is differentiated from vessel tissue surrounding/defining the vessel lumen).
- the vessel lumen is differentiated from vessel tissue surrounding/defining the vessel lumen.
- other anatomy can be selected with the subtract tool besides vessel lumens, including without limitation vessel walls, occlusions (e.g., clots, webbing, calcifications, stenoses, compressions, etc.), side branches, tumors and other anomalies, neighboring anatomy, and/or other regions of interest.
- aspects of the present disclosure apply to any adjacent pair of anatomical regions of interest that need to be differentiated.
- Figure 20 is a screen display 700 showing the automatically identified lumen boundary 2010 of the lumen 630a in the IVUS image 610, according to aspects of the present disclosure. Visible are the first lumen 630a, second lumen 630b, anomalous dark region 1620, and position indicator 640.
- the context-sensitive intravascular measurement system automatically deletes the second lumen 630b and anomalous dark region 1620 from the identified lumen area, and recalculates or redetermines the lumen boundary 2010 and measurements 2020.
- Figure 21 is a schematic, diagrammatic view, in flow diagram form, of an example lumen area subtraction method 2100, according to aspects of the present disclosure.
- the method 2100 includes receiving, within a screen display 2110 of the IVUS image, a user input (e.g., from a touchscreen, keyboard, mouse, etc.) indicating an input sub-area that is inside the area the user wishes to subtract from the identified lumen area.
- a user input e.g., from a touchscreen, keyboard, mouse, etc.
- step 2130 the method 2100 includes identifying the area to subtract from the identified lumen area. This may for example employ the same identification methods described above in Figure 8. Execution then proceeds to step 2140.
- step 2140 the method 2100 includes modifying the lumen border to remove the subtracted area. This may for example involve the same border identification methods described above in Figure 8. Execution then proceeds to step 2150.
- step 2150 the method 2100 includes re-calculating the lumen area and other dimensional parameters based on the modified lumen border and/or the modified lumen area, as descried above in Figure 8. Execution then proceeds to step 2160.
- step 2160 the method 2100 includes generating and outputting a screen display that overlays the modified lumen border and/or the re-calculated lumen dimensions on top of the IVUS image. The method is now complete.
- Figure 22 is a grid 1100 showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- the identified lumen area 1110 is anomalously large, and so the user has identified an input sub-region 2210 within a portion 2220 of the identified lumen area 1110 that the user wishes to remove from the identified sub-area.
- the identified lumen area 1110 includes sub-regions with parameter values as high as 5, resulting in the anomalously large lumen area 1110.
- Figure 23 is a grid 1100 showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- the identified lumen area 1310 has been resized, by removing a second lumen area 2310, as well as vessel walls 2320 and 2330, from the lumen area 1110 of Figure 22.
- Figure 24 is a screen display 2400 showing an IVUS image 610, an image longitudinal display (ILD) 620, and a drawing tool 2450, according to aspects of the present disclosure. Visible in the IVUS image 610 and the ILD 620 are the first vessel lumen 630a and second vessel lumen 630b.
- the position indicator 640 shows the position of the current IVUS image frame 610 within the ILD 620.
- the user has drawn a partial curve or partial drawing 2410 tracing a portion of the boundary of lumen 630a.
- a temporary completion line 2420 joins the endpoints of the partial curve 2410.
- the context-sensitive intravascular measurement system is able to auto-complete the lumen boundary.
- Figure 25 is a screen display 2500 showing an IVUS image 610, an image longitudinal display (ILD) 620, and an automatically completed lumen boundary drawing 2510, according to aspects of the present disclosure. Visible in the IVUS image 610 and the ILD 620 are the first vessel lumen 630a and second vessel lumen 630b. The position indicator 640 shows the position of the current IVUS image frame 610 within the ILD 620. In the example shown in Figure 25, the partial curve 2410 drawn by the user in Figure 24 has been auto-completed by the context-sensitive intravascular measurement system, thus creating the automatically completed lumen boundary drawing 2510. Measurements can now be made from this lumen boundary.
- ILD image longitudinal display
- the present disclosure uses vessel lumens as an example anatomical region of interest for selection and measurement (e.g., the vessel lumen is differentiated from vessel tissue surrounding/defining the vessel lumen).
- the vessel lumen is differentiated from vessel tissue surrounding/defining the vessel lumen.
- other anatomy can be automatically completed with the automatic completion tool besides vessel lumens, including without limitation vessel walls, occlusions (e.g., clots, webbing, calcifications, stenoses, compressions, etc.), side branches, tumors and other anomalies, neighboring anatomy, and/or other regions of interest.
- aspects of the present disclosure apply to any adjacent pair of anatomical regions of interest that need to be differentiated.
- Figure 26A is a schematic, diagrammatic view, in flow diagram form, of an example lumen boundary autocompletion method 2600, according to aspects of the present disclosure.
- step 2615 the method 2600 includes receiving, within a screen display 2610 of the IVUS image, a user input (e.g., from a touchscreen, keyboard, mouse joystick, trackball, etc.) identifying a first portion (e.g., a hand-drawn portion) of the lumen border. Execution then proceeds to step 2620.
- a user input e.g., from a touchscreen, keyboard, mouse joystick, trackball, etc.
- a first portion e.g., a hand-drawn portion
- the method 2600 includes determining IVUS image parameters (e.g., brightness, depth, frequency, etc.) on a first side and a second side of the first portion. If the first portion of the border is drawn accurately, then a sub-area immediately on one side of the border should have lumen-like parameters (e.g., low brightness, etc.), and a sub-area immediately on the opposite side should have vessel-wall-like parameters (e.g., high brightness, etc.). Execution then proceeds to step 2625.
- IVUS image parameters e.g., brightness, depth, frequency, etc.
- the method 2600 includes automatically determining a relationship between the inside parameters (e.g., lumen parameters) and the outside parameters (e.g., vessel wall parameters).
- the outside parameters may exceed a particular threshold, whereas the inside parameters may be within the threshold.
- Other possible relationships between inside parameters and outside parameters include a ratio, a difference, an average, etc. Execution then proceeds to step 2630.
- the method 2600 includes determining a second portion of the border that completes the border (e.g., that connects to the two endpoints of the first portion), and that maintains the relationship identified in step 2625 (e.g., a border where the parameter for all subareas inside the border falls below the identified threshold, and all sub-areas immediately outside the border exceed the threshold), as described below in Figures 27-28. Execution then proceeds to step 2635.
- step 2635 the method 2600 includes calculating the lumen dimensions based on the lumen border and/or the lumen area associated with the completed border. Execution then proceeds to step 2640.
- step 2640 the method 2600 includes generating and outputting a screen display that includes the first portion and the second portion of the border and/or the calculated dimensions, overlaid on the intravascular (e.g., IVUS) image. The method is now complete.
- Figure 26B is a schematic, diagrammatic view, in flow diagram form, of an example lumen boundary autocompletion method 2650, according to aspects of the present disclosure.
- the method 2650 includes receiving, within a screen display 2610 of the IVUS image, a user input (e.g., from a touchscreen, keyboard, mouse, trackball, joystick, etc.) identifying a first portion (e.g., a hand-drawn portion) of the lumen border. Execution then proceeds to step 2660.
- a user input e.g., from a touchscreen, keyboard, mouse, trackball, joystick, etc.
- the method 2650 includes determining IVUS image parameters on a first side and a second side of the first portion. For example, if the first portion of the border is drawn accurately, then a sub-area on one side of the border should have lumen-like parameters, and a sub-area on the opposite side should have vessel-wall-like parameters. Execution then proceeds to step 2665.
- step 2665 the method 2650 includes comparing the first-side parameters and the second-side parameters to pre-determined parameters for the lumen area. Execution then proceeds to step 2670.
- step 2670 the method 2650 includes identifying either the first side or the second side as part of the lumen area (e.g., as described above in Figure 8). Execution then proceeds to step 2675.
- the method 2650 includes determining a second portion of the border that completes the border (e.g., that connects to the two endpoints of the first portion), based on the identification of the first side or the second side as being part of the lumen. Points located in between the first side and the second side can be identified as belonging to the border. Execution then proceeds to step 2680.
- step 2680 the method 2650 includes calculating the lumen dimensions based on the lumen border and/or the lumen area associated with the completed border. Execution then proceeds to step 2685.
- the method 2650 includes generating and outputting a screen display that includes the first portion and the second portion of the border and/or the calculated dimensions, overlaid on the intravascular (e.g., IVUS) image.
- the intravascular e.g., IVUS
- Figure 27 is a grid 1100 showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- the lumen area 2710 is defined by a partial hand-drawn border 2410 and a temporary completion line 2420 that connects the endpoints of the partial hand-drawn border 2410.
- the defined lumen area 2710 is not representative of the actual lumen area, until the context-sensitive intravascular measurement system performs an intelligent autocompletion of the border, as shown below in Figure 28.
- Figure 28 is a grid 1100 showing numerical values of an image parameter in an IVUS image frame, according to aspects of the present disclosure.
- the lumen area 2810 is now defined by the partial hand-drawn border 2410 and an autocompleted border 2510, that separates vessel wall sub-areas 1510 from the lumen area 2810.
- an area 2830 meets the criteria for inclusion in the lumen area (e.g., a parameter value of 3 or less), but was excluded by the hand-drawn partial border 2410.
- the autocompleted border 2510 may overwrite or correct such disputed portions of the hand-drawn partial border 2410 such that the entire lumen area is included in the final border.
- Figure 29 is a screen display 2900 showing an IVUS image 610, an image longitudinal display (ILD) 620, and a selection tool or add tool 650, according to aspects of the present disclosure. Visible in the IVUS image 610 and the ILD 620 are the first vessel lumen 630a and a second vessel lumen 630b. The position indicator 640 shows the position of the current IVUS image frame 610 within the ILD 620.
- a current image frame number 2950 and a total number of image frames 2960 Also visible is a current image frame number 2950 and a total number of image frames 2960.
- the add tool 650 was used to select an area in the IVUS image 610.
- the add tool 650 is dragged along the ILD to highlight all of the IVUS image frames 610 within a region of interest 2920 of a particular vessel lumen.
- the position indicator 640 can be moved up and down along the ILD to display different image frames 610. If these frames contain portions of the region of interest 2920, then an automatically calculated border 2930 and measurements 2940 will be displayed on the IVUS image frame 610 for the selected lumen.
- the ILD may be horizontal rather than vertical.
- the present disclosure uses vessel lumens as an example anatomical region of interest for selection and measurement (e.g., the vessel lumen is differentiated from vessel tissue surrounding/defining the vessel lumen).
- vessel lumens e.g., the vessel lumen is differentiated from vessel tissue surrounding/defining the vessel lumen.
- other anatomy can be selected with the ILD add tool besides vessel lumens, including without limitation vessel walls, occlusions (e.g., clots, webbing, calcifications, stenoses, compressions, etc.), side branches, tumors and other anomalies, neighboring anatomy, and/or other regions of interest.
- aspects of the present disclosure apply to any adjacent pair of anatomical regions of interest that need to be differentiated.
- Figure 30 is a screen display3000 showing an IVUS image 610 and an image longitudinal display (ILD) 620, according to aspects of the present disclosure. Visible in the IVUS image 610 and the ILD 620 are the first vessel lumen 630a and a second vessel lumen 630b. The position indicator 640 shows the position of the current IVUS image frame 610 within the ILD 620. Also visible are the region of interest 2920, frame number 2950, lumen border 2930, and measurements 2940. Because the frame number 2950 is different than the frame number shown in Figure 29, the IVUS image frame 610 is from a different portion of the region of interest, and so the lumen border 2930 and measurement 2940 are different than those shown in Figure 29.
- ILD image longitudinal display
- Figure 31 is a schematic, diagrammatic view, in flow diagram form, of an example lumen boundary autocompletion method 3100, according to aspects of the present disclosure.
- the method 3100 includes receiving, within a screen display 3110 of a first IVUS image A, a user input (e.g., from a touchscreen, mouse, keyboardjoystick, trackball, etc.) identifying locations inside the lumen border in the ILD. Execution then proceeds to step 3130.
- a user input e.g., from a touchscreen, mouse, keyboardjoystick, trackball, etc.
- step 3130 the method 3100 includes determining which IVUS image frames (or other tomographic image) correspond to the user input (e.g., which images are represented in the touched portions of the ILD). Execution then proceeds to step 3140.
- step 3140 the method 3100 includes, for each IVUS image frame corresponding to the user input, associating a portion of the user input with the current IVUS image frame. Execution then proceeds to step 3150.
- step 3150 the method 3100 includes mapping a location inside the lumen area in longitudinal view (e.g., from the user input) to a corresponding location inside the lumen area in the current IVUS image frame. Execution then proceeds to step 3160.
- step 3160 the method 3100 includes determining the lumen border and lumen area in the IVUS image frame (e.g., as described above in Figure 8). Execution then proceeds to step 3170.
- step 3170 the method 3100 includes calculating the lumen dimension parameters based on the lumen border and/or lumen area. Execution then proceeds to step 3180.
- step 3180 the method 3100 includes generating and outputting a screen display with the ILD (with an indicator for the user identified region of interest) and/or IVUS image frame B (overlaid with the lumen border) and/or the calculated dimension parameters. The method is now complete.
- the context-sensitive intravascular measurement system advantageously permits the users of intraluminal imaging systems to determine the dimensions of anatomy such as a vessel lumen, with enhanced speed, accuracy, and repeatability, plus an ability to edit the lumen borders by novel means.
- This technology can be applied to other types of ultrasound devices besides IVUS, including but not limited to 2D or 3D external ultrasound, trans-esophageal echography (TEE), or intracardiac echography (ICE), as well as optoacoustic or photoacoustic imaging technologies such as optical coherence tomography (OCT).
- TEE trans-esophageal echography
- ICE intracardiac echography
- OCT optical coherence tomography
- the technology can be used in either or both of veins and arteries, including coronary arteries.
- All directional references e.g., upper, lower, inner, outer, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal are only used for identification purposes to aid the reader’s understanding of the claimed subject matter, and do not create limitations, particularly as to the position, orientation, or use of the context-sensitive intravascular measurement system.
- Connection references e.g., attached, coupled, connected, joined, or “in communication with” are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily imply that two elements are directly connected and in fixed relation to each other.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Medical Informatics (AREA)
- Veterinary Medicine (AREA)
- Biophysics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pathology (AREA)
- Radiology & Medical Imaging (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- Physics & Mathematics (AREA)
- Molecular Biology (AREA)
- Surgery (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Physiology (AREA)
- Computer Vision & Pattern Recognition (AREA)
- Vascular Medicine (AREA)
- Ultra Sonic Daignosis Equipment (AREA)
Abstract
Un appareil comprend un circuit processeur conçu pour une communication avec un cathéter d'imagerie intravasculaire. Le circuit processeur est conçu pour délivrer, à un dispositif d'affichage avec lequel il est en communication, un premier affichage d'écran comprenant une image intravasculaire obtenue par le cathéter d'imagerie intravasculaire, l'image intravasculaire comprenant une lumière de vaisseau sanguin et un tissu de vaisseau sanguin. Le circuit processeur est en outre conçu pour recevoir, sur l'image intravasculaire, une entrée utilisateur unique identifiant un emplacement à l'intérieur d'une région d'intérêt, et déterminer automatiquement, en réponse à l'entrée utilisateur unique, une limite de la région d'intérêt, la limite entourant l'emplacement identifié par l'entrée utilisateur unique. Le circuit processeur est en outre conçu pour délivrer, à l'affichage, un second affichage d'écran comprenant l'image intravasculaire et la limite de la région d'intérêt superposée sur l'image intravasculaire.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202363600110P | 2023-11-17 | 2023-11-17 | |
| US63/600,110 | 2023-11-17 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025103969A1 true WO2025103969A1 (fr) | 2025-05-22 |
Family
ID=93563596
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/EP2024/081934 Pending WO2025103969A1 (fr) | 2023-11-17 | 2024-11-12 | Détection de limite d'image intravasculaire en réponse à la localisation à l'intérieur d'une région et systèmes, dispositifs et procédés associés |
Country Status (1)
| Country | Link |
|---|---|
| WO (1) | WO2025103969A1 (fr) |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US6381350B1 (en) * | 1999-07-02 | 2002-04-30 | The Cleveland Clinic Foundation | Intravascular ultrasonic analysis using active contour method and system |
| US20070201736A1 (en) | 2004-03-04 | 2007-08-30 | Klingensmith Jon D | System and method for vascular border detection |
| US20090080738A1 (en) * | 2007-05-01 | 2009-03-26 | Dror Zur | Edge detection in ultrasound images |
| US7846101B2 (en) | 1995-12-26 | 2010-12-07 | Volcano Corporation | High resolution intravascular ultrasound transducer assembly having a flexible substrate |
| US9295447B2 (en) | 2011-08-17 | 2016-03-29 | Volcano Corporation | Systems and methods for identifying vascular borders |
| US20190282211A1 (en) | 2018-03-14 | 2019-09-19 | Volcano Corporation | Scoring intravascular lesions and stent deployment in medical intraluminal ultrasound imaging |
| US20200029932A1 (en) | 2018-07-30 | 2020-01-30 | Koninklijke Philips N.V. | Systems, devices, and methods for displaying multiple intraluminal images in luminal assessment with medical imaging |
| US11272845B2 (en) | 2012-10-05 | 2022-03-15 | Philips Image Guided Therapy Corporation | System and method for instant and automatic border detection |
| US11744527B2 (en) | 2018-03-15 | 2023-09-05 | Philips Image Guided Therapy Corporation | Determination and visualization of anatomical landmarks for intraluminal lesion assessment and treatment planning |
-
2024
- 2024-11-12 WO PCT/EP2024/081934 patent/WO2025103969A1/fr active Pending
Patent Citations (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7846101B2 (en) | 1995-12-26 | 2010-12-07 | Volcano Corporation | High resolution intravascular ultrasound transducer assembly having a flexible substrate |
| US6381350B1 (en) * | 1999-07-02 | 2002-04-30 | The Cleveland Clinic Foundation | Intravascular ultrasonic analysis using active contour method and system |
| US20070201736A1 (en) | 2004-03-04 | 2007-08-30 | Klingensmith Jon D | System and method for vascular border detection |
| US7463759B2 (en) | 2004-03-04 | 2008-12-09 | The Cleveland Clinic Foundation | System and method for vascular border detection |
| US20090080738A1 (en) * | 2007-05-01 | 2009-03-26 | Dror Zur | Edge detection in ultrasound images |
| US9295447B2 (en) | 2011-08-17 | 2016-03-29 | Volcano Corporation | Systems and methods for identifying vascular borders |
| US11272845B2 (en) | 2012-10-05 | 2022-03-15 | Philips Image Guided Therapy Corporation | System and method for instant and automatic border detection |
| US20190282211A1 (en) | 2018-03-14 | 2019-09-19 | Volcano Corporation | Scoring intravascular lesions and stent deployment in medical intraluminal ultrasound imaging |
| US11744527B2 (en) | 2018-03-15 | 2023-09-05 | Philips Image Guided Therapy Corporation | Determination and visualization of anatomical landmarks for intraluminal lesion assessment and treatment planning |
| US20200029932A1 (en) | 2018-07-30 | 2020-01-30 | Koninklijke Philips N.V. | Systems, devices, and methods for displaying multiple intraluminal images in luminal assessment with medical imaging |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US11596384B2 (en) | Intraluminal ultrasound vessel border selection and associated devices, systems, and methods | |
| US20240023928A1 (en) | Speed determination for intraluminal ultrasound imaging and associated devices, systems, and methods | |
| US12440188B2 (en) | Graphical longitudinal display for intraluminal ultrasound imaging and associated devices, systems, and methods | |
| US20250195032A1 (en) | Intraluminal ultrasound navigation guidance and associated devices, systems, and methods | |
| EP3870069B1 (fr) | Guidade directionnel ultrasonore intraluminal et dispositifs et systèmes associés | |
| US12178642B2 (en) | Disease specific and treatment type specific control of intraluminal ultrasound imaging | |
| US12458447B2 (en) | Co-registration of intravascular data and multi-segment vasculature, and associated devices, systems, and methods | |
| US20250349023A1 (en) | Intraluminal image-based vessel diameter determination and associated devices, systems, and methods | |
| US20230045488A1 (en) | Intraluminal imaging based detection and visualization of intraluminal treatment anomalies | |
| US12205239B2 (en) | Intraluminal image visualization with adaptive scaling and associated systems, methods, and devices | |
| WO2025103969A1 (fr) | Détection de limite d'image intravasculaire en réponse à la localisation à l'intérieur d'une région et systèmes, dispositifs et procédés associés | |
| WO2025168460A1 (fr) | Imagerie intravasculaire pour planification d'endoprothèse avec visualisation et ajustement simultanés de zone de pose, |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| 121 | Ep: the epo has been informed by wipo that ep was designated in this application |
Ref document number: 24808581 Country of ref document: EP Kind code of ref document: A1 |