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WO2025209904A1 - Image longitudinale intravasculaire avec partie tournée pour visualisation de branche latérale - Google Patents

Image longitudinale intravasculaire avec partie tournée pour visualisation de branche latérale

Info

Publication number
WO2025209904A1
WO2025209904A1 PCT/EP2025/058316 EP2025058316W WO2025209904A1 WO 2025209904 A1 WO2025209904 A1 WO 2025209904A1 EP 2025058316 W EP2025058316 W EP 2025058316W WO 2025209904 A1 WO2025209904 A1 WO 2025209904A1
Authority
WO
WIPO (PCT)
Prior art keywords
processor circuit
angle
sectional
blood vessel
vessel
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
Application number
PCT/EP2025/058316
Other languages
English (en)
Inventor
Walter Ruetten
Harold Agnes Wilhelmus Schmeitz
Rogier Rudolf WILDEBOER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Koninklijke Philips NV
Original Assignee
Koninklijke Philips NV
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Koninklijke Philips NV filed Critical Koninklijke Philips NV
Publication of WO2025209904A1 publication Critical patent/WO2025209904A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0062—Arrangements for scanning
    • A61B5/0066—Optical coherence imaging
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0059—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence
    • A61B5/0082—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes
    • A61B5/0084—Measuring for diagnostic purposes; Identification of persons using light, e.g. diagnosis by transillumination, diascopy, fluorescence adapted for particular medical purposes for introduction into the body, e.g. by catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording for evaluating the cardiovascular system, e.g. pulse, heart rate, blood pressure or blood flow
    • A61B5/02007—Evaluating blood vessel condition, e.g. elasticity, compliance
    • 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
    • A61B8/13—Tomography
    • A61B8/14—Echo-tomography
    • A61B8/145—Echo-tomography characterised by scanning multiple planes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/445—Details of catheter construction
    • 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
    • A61B8/48—Diagnostic techniques
    • 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
    • A61B8/5238—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for combining image data of patient, e.g. merging several images from different acquisition modes into one image
    • A61B8/5246—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for combining image data of patient, e.g. merging several images from different acquisition modes into one image combining images from the same or different imaging techniques, e.g. color Doppler and B-mode

Definitions

  • the present disclosure relates generally to intravascular imaging and, in particular, to a longitudinal view of a blood vessel that simultaneously displays multiple side branches. For example, Doppler measurement of transverse flow velocity can be used to detect the presence of side branches.
  • the invention pertains to a processing circuit, a medical system comprising the processing circuit, a computer implemented method and a computer program for implementing the method.
  • 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 or reflections to produce a cross-sectional image of the vessel where the device is placed.
  • said measurements may be distorted by side branches.
  • side branches Despite recognizable by reviewing (i.e., sliding through) the entire pullback recording, the absence of three-dimensional information in a single frame will complicate the lumen/vessel wall interpretation especially at the ostia locations of the side branches.
  • ill-defined side branches may also reduce the reproducibility of automatic measurements.
  • OCT optical coherence tomography
  • a processor circuit for generating an intravascular cross-sectional longitudinal view (also referred to as intravascular cross-sectional longitudinal image) of a blood vessel comprised in in the form of a screen display.
  • intravascular cross-sectional longitudinal view also referred to as intravascular cross-sectional longitudinal image
  • Such generation may be done by the processor circuit by processing received intraluminal imaging data representative of intraluminal images that have been recorded using an intravascular imaging device (e.g. guidewire or catheter).
  • intravascular imaging device e.g. guidewire or catheter
  • the further processor circuit is configured for communication with the processor circuit and for causing the processor circuit to perform the method of claim 13, optionally, in response to, or based on, a user input received by the further processor circuit; and optionally, by the further processor circuit configured for communication with the display device, receiving the screen display and controlling the display device to display the screen display to the user.
  • the processor circuit itself may not need to be configured for communication with the display device.
  • the further processor circuit can be different from the processor circuit.
  • the further processor circuit may be a client device and the processor circuit a host device.
  • the client device can be a bedside or local device whereas the host device can be a remote device, possibly as part of a network.
  • Figure l is a schematic diagram of an intraluminal imaging system, according to aspects of the present disclosure.
  • Figure 3 illustrates a perspective view of the scanner assembly in a rolled configuration, according to aspects of the present disclosure.
  • Figure 4 is a diagrammatic cross-sectional side view of a distal portion of the intraluminal imaging device, including the flexible substrate and the support member, according to aspects of the present disclosure.
  • Figure 6 is a schematic, diagrammatic, side cross-sectional view of a pullback procedure, wherein an intraluminal imaging device is pulled from a distal position to a proximal position within a blood vessel of a patient, according to aspects of the present disclosure.
  • Figure 8 is a screen display of an example intraluminal imaging system, according to aspects of the present disclosure.
  • Figure 9A is a perspective view of a volume of intravascular imaging data, according to aspects of the present disclosure.
  • Figure 9B is a perspective view of the volume of intravascular imaging data of Figure 9A, according to aspects of the present disclosure.
  • Figure 9C is an image longitudinal display shown along the imaging plane of Figure 9B, according to aspects of the present disclosure.
  • Figure 9D is a top view of tomographic image, according to aspects of the present disclosure.
  • Figure 10A is a perspective view of the volume of intravascular imaging data of Figure 9B, according to aspects of the present disclosure.
  • Figure 10B is an image longitudinal display or ILD shown along the imaging plane of Figure 10A, according to aspects of the present disclosure.
  • Figure 10C is a perspective view of the volume of intravascular imaging data of Figure 9B, according to aspects of the present disclosure.
  • Figure 10D is an image longitudinal display or ILD shown along the imaging plane of Figure 10C, according to aspects of the present disclosure.
  • Figure 10E is a perspective view of the volume of intravascular imaging data of Figure 9B, according to aspects of the present disclosure.
  • Figure 10F is an image longitudinal display or ILD shown along the imaging plane of Figure 10E, according to aspects of the present disclosure.
  • Figure 11A is a perspective view of the volume of intravascular imaging data of Figure 9A, according to aspects of the present disclosure.
  • Figure 11B is a perspective view of the volume of intravascular imaging data of Figure 11 A, according to aspects of the present disclosure.
  • Figure 11C is an image longitudinal display or ILD shown along the three different imaging planes of Figure 11 A, according to aspects of the present disclosure.
  • Figure 11D is a top view of tomographic image, according to aspects of the present disclosure.
  • Figure 12A is a schematic, diagrammatic, perspective view of an example blood vessel, according to aspects of the present disclosure.
  • Figure 12B is a schematic, diagrammatic, perspective view of an example blood vessel, according to aspects of the present disclosure.
  • Figure 13 is a schematic, diagrammatic representation, in flow diagram form, of an example image longitudinal display method, according to at least one embodiment of the present disclosure.
  • Figure 14 is a schematic, diagrammatic representation, in flow diagram form, of an example side branch identification method, according to at least one embodiment of the present disclosure.
  • Figure 15 is a schematic, diagrammatic representation, in flow diagram form, of an example image longitudinal display generation method, according to at least one embodiment of the present disclosure.
  • Figure 16 is a schematic, diagrammatic representation, in flow diagram form, of an example image longitudinal display generation method, according to at least one embodiment of the present disclosure.
  • Figure 18A is a schematic, diagrammatic, perspective view of an example blood vessel, according to aspects of the present disclosure.
  • Figure 18B is an image longitudinal display or ILD showing a sequence of tomographic image slices of the vessel of Figure 18 A, according to aspects of the present disclosure.
  • Figure 19 is schematic, diagrammatic view of a transverse velocity measurement process, according to aspects of the present disclosure.
  • Figure 20 is schematic, diagrammatic view of a transverse velocity measurement process, according to aspects of the present disclosure.
  • Figure 21 is schematic, diagrammatic view of a transverse velocity measurement process, according to aspects of the present disclosure.
  • Figure 22 is schematic, diagrammatic view of a transverse velocity measurement process, according to aspects of the present disclosure.
  • Figure 23 is a screen display for an example multi-angle longitudinal display system, according to aspects of the present disclosure.
  • the orientation of the catheter - and, perpendicularly, the imaging plane - relates to its movement and the angle with respect to the local flow profile of the bloodstream. Both in case of the catheter oriented off the longitudinal vessel axis or being near the beginning of a side branch, there will exist a flow component perpendicular to the catheter axis. By adopting brief Doppler ultrasound image sequences or measurement sequences into the imaging chain, these flow components can be detected and measured to reduce the variability and/or inaccuracy of IVUS measurements. The most reliable IVUS-based measurements can be made when the catheter is aligned with the longitudinal axis of the examined vessel, and taking potential side branching into account.
  • a Doppler sequence is inserted in the IVUS imaging chain.
  • Flow components perpendicular to the catheter orientation i.e., parallel to the ultrasound imaging plane
  • Doppler firings with the B-mode and/or derive motion from the B-mode firings.
  • a higher flow at the edge of an automatically segmented lumen may be used in the identification of side branches.
  • the detection of side branches may be important in the visualization of the image longitudinal display (ILD), planning of stent placement and other treatment options, and to guide automatic segmentation of lumen and vessel boundaries.
  • ILD image longitudinal display
  • a processor can use the obtained flow components (e.g., Doppler velocity measurements) - especially those close to the outer (automatic) delineation of the lumen - to detect the longitudinal location (position along the length of vessel) and/or circumferential location (angle around the vessel). Use of this information can include using a threshold to decide if the side branch has been detected or not and using the, e.g., the near-edge Doppler components of each scan line as input to a neural network.
  • Doppler velocity measurements e.g., Doppler velocity measurements
  • the multi-angle longitudinal display has particular but not exclusive utility for ultrasound imaging of blood vessels.
  • the present disclosure aids substantially in visualizing body lumens such as blood vessels, by improving the ability to see multiple side branches in a single display.
  • a processor such as a patient interface module (PIM) and/or IVUS imaging console
  • the multi-angle longitudinal display disclosed herein provides practical improvements in the user-interpretability of IVUS image stacks (e.g., obtained during a pullback sequence).
  • This improved image display technique transforms a system where a user must “hunt” for multiple display angles in order to understand the positions of side branches, into one where all such side branches are visible at a glance, without user intervention. This is accomplished without the normally routine need to rotate the angle at which the ILD is cross-sectioned from the IVUS image stack.
  • This unconventional approach improves the functioning of the ultrasound imaging system, by making its outputs more useful to the end user.
  • the multi-angle longitudinal display may be implemented as a process at least partially viewable on a display device, 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.
  • Outputs of the multi-angle longitudinal display may be printed, shown on a display device, or otherwise communicated to a user or human operator.
  • FIG. 1 is a schematic diagram of an intraluminal imaging system 100, according to aspects of the present disclosure.
  • the intraluminal imaging system 100 can be an ultrasound imaging system.
  • the system 100 can be an intravascular ultrasound (IVUS) imaging system.
  • the intravascular imaging system can for example be an intravascular ultrasound (IVUS) imaging system, an intravascular optical coherence tomography (OCT) imaging system, or intravascular photoacoustic (PA) imaging system.
  • the system 100 may include a corresponding intraluminal imaging device 102.
  • the intraluminal imaging device 102 can thus be an ultrasound imaging device or an optical coherence tomography imaging device or a photoacoustic imaging device. Preferably such device is configured for intravascular imaging.
  • the intraluminal imaging device 102 preferably comprises, or is in the form of, a catheter, guide wire, or guide catheter.
  • the device 102 can be an IVUS imaging device, such as a solid-state IVUS device.
  • the system shown can include a patient interface module (PIM) 104, a processing system or console 106, and a display device 108.
  • PIM patient interface module
  • the IVUS device 102 emits ultrasonic energy from a transducer array 124 included in scanner assembly 110, also referred to as an IVUS imaging assembly, mounted near a distal end of the catheter device.
  • the ultrasonic energy is reflected by tissue structures in the surrounding medium, such as a vessel 120, or another body lumen surrounding the scanner assembly 110, and the ultrasound echo signals are received by the transducer array 124.
  • the device 102 can be sized, shaped, or otherwise configured to be positioned within the body lumen of a patient.
  • the PIM 104 transfers the received echo signals to the console or computer 106 where the ultrasound image (including flow information in some embodiments) is reconstructed and displayed on the monitor 108.
  • the console or computer 106 can include a processor and a memory.
  • the computer or computing device 106 can be operable to facilitate the features of the IVUS imaging system 100 described herein.
  • the processor can execute computer readable instructions stored on the non-transitory tangible computer readable medium.
  • the IVUS device includes some features similar to traditional solid-state IVUS catheters, such as the EagleEye® catheter available from Volcano Corporation and those disclosed in U.S. Patent No. 7,846,101 hereby incorporated by reference in its entirety.
  • the IVUS device 102 includes the scanner assembly 110 near a distal end of the device 102 and a transmission line bundle 112 extending along the longitudinal body of the device 102.
  • the transmission line bundle or cable 112 can include a plurality of conductors, including one, two, three, four, five, six, seven, or more conductors 218 (Fig. 2). It is understood that any suitable gauge wire can be used for the conductors 218.
  • the cable 112 can include a four-conductor transmission line arrangement with, e.g., 41 AWG gauge wires. In an embodiment, the cable 112 can include a seven-conductor transmission line arrangement utilizing, e.g., 44 AWG gauge wires. In some embodiments, 43 AWG gauge wires can be used. [0025]
  • the transmission line bundle 112 terminates in a PIM connector 114 at a proximal end of the device 102.
  • the PIM connector 114 electrically couples the transmission line bundle 112 to the PIM 104 and physically couples the IVUS device 102 to the PIM 104.
  • the IVUS device 102 further includes a guide wire exit port 116. Accordingly, in some instances the IVUS device is a rapid-exchange catheter.
  • the guide wire exit port 116 allows a guide wire 118 to be inserted towards the distal end in order to direct the device 102 through the vessel 120.
  • the control logic dies 206 are not necessarily homogenous.
  • a single controller is designated a master control logic die 206A and contains the communication interface for cable 112, between a processing system, e.g., processing system 106, and the flexible assembly 110.
  • the master control circuit may include control logic that decodes control signals received over the cable 112, transmits control responses over the cable 112, amplifies echo signals, and/or transmits the echo signals over the cable 112.
  • the remaining controllers are slave controllers 206B.
  • the slave controllers 206B may include control logic that drives a plurality of transducer elements 212 to emit an ultrasonic signal and selects a transducer element 212 to receive an echo.
  • the flexible substrate 214 includes conductive traces 216 formed in the film layer that carry signals between the control logic dies 206 and the transducer elements 212.
  • the conductive traces 216 providing communication between the control logic dies 206 and the transducer elements 212 extend along the flexible substrate 214 within the transition region 210.
  • the conductive traces 216 can also facilitate electrical communication between the master controller 206 A and the slave controllers 206B.
  • Figure 3 illustrates a perspective view of the scanner assembly 110 in a rolled configuration, according to aspects of the present disclosure.
  • the flexible substrate 214 is transitioned from a flat configuration (see Figure 2) to a rolled or more cylindrical configuration (as shown here in Figure 3).
  • techniques are utilized as disclosed in one or more of U.S. Patent No. 6,776,763, titled “ULTRASONIC TRANSDUCER ARRAY AND METHOD OF MANUFACTURING THE SAME” and U.S. Patent No. 7,226,417, titled “HIGH RESOLUTION INTRAVASCULAR ULTRASOUND SENSING ASSEMBLY HAVING A FLEXIBLE SUBSTRATE,” each of which is hereby incorporated by reference in its entirety.
  • the central body portion of the support member can include recesses allowing fluid communication between the lumen of the unibody and the cavities between the flexible substrate 214 and the support member 230. Acoustic backing material 246 and/or underfill material 247 can be introduced via the cavities (during an assembly process, prior to the inner member 256 extending through the lumen of the unibody.
  • suction can be applied via the passageways 235 of one of the stands 242, 244, or to any other suitable recess while the liquid backing material 246 is fed between the flexible substrate 214 and the support member 230 via the passageways 235 of the other of the stands
  • the backing material can be cured to allow it to solidify and set.
  • the support member 230 includes more than three stands 242,
  • the support member 230 can have an increased diameter distal portion 262 and/or increased diameter proximal portion 264 that is sized and shaped to elevate and support the distal and/or proximal portions of the flexible substrate 214.
  • an inner diameter of the support member 230 (e.g., the diameter of the lumen 236) can correspondingly increase or decrease as the outer diameter changes. In other embodiments, the inner diameter of the support member 230 remains the same despite variations in the outer diameter.
  • a proximal inner member 256 and a proximal outer member 254 are coupled to the proximal portion 264 of the support member 230.
  • the proximal inner member 256 and/or the proximal outer member 254 can comprise a flexible elongate member.
  • the proximal inner member 256 can be received within a proximal flange 234.
  • the proximal outer member 254 abuts and is in contact with the proximal end of flexible substrate 214.
  • a distal tip member 252 is coupled to the distal portion 262 of the support member 230.
  • the distal member 252 is positioned around the distal flange 232.
  • the tip member 252 can abut and be in contact with the distal end of flexible substrate 214 and the stand 242. In other embodiments, the proximal end of the tip member 252 may be received within the distal end of the flexible substrate 214 in its rolled configuration. In some embodiments there may be a gap between the flexible substrate 214 and the tip member 252.
  • the distal member 252 can be the distal-most component of the intraluminal imaging device 102.
  • the distal tip member 252 may be a flexible, polymeric component that defines the distal-most end of the imaging device 102.
  • the distal tip member 252 may additionally define a lumen in communication with the lumen 236 defined by support member 230.
  • the guide wire 118 may extend through lumen 236 as well as the lumen defined by the tip member 252.
  • One or more adhesives can be disposed between various components at the distal portion of the intraluminal imaging device 102.
  • one or more of the flexible substrate 214, the support member 230, the distal member 252, the proximal inner member 256, the transducer array 212, and/or the proximal outer member 254 can be coupled to one another via an adhesive.
  • the adhesive can be in contact with e.g. the transducer array 212, the flexible substrate 214, the support member 230, the distal member 252, the proximal inner member 256, and/or the proximal outer member 254, among other components.
  • FIG. 5 is a schematic diagram of a processor circuit 550, according to embodiments 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 schematic, diagrammatic, side cross-sectional view of a pullback procedure 600, wherein an intraluminal imaging device 102 is pulled from a distal position to a proximal position within a blood vessel 120 of a patient, according to aspects of the present disclosure.
  • the imaging plane 610 of the transducer array 124 moves proximally along the blood vessel 120, capturing a sequence of tomographic images as described below. These tomographic images may be displayed individually, or combined into a longitudinal display.
  • FIG. 7 is a screen display 700 of an example intraluminal imaging system 100, according to aspects of the present disclosure.
  • the screen display 700 includes a tomographic (e.g., lateral or radial cross-sectional) image 710 of the blood vessel 120 and surrounding tissue 720, as well as an estimated lumen boundary 730 and associated measurements 740.
  • the screen display 700 also includes a longitudinal cross-sectional image 750 of the blood vessel 120, assembled from a stacked sequence of tomographic images, sliced longitudinally at a particular clock angle, as described below.
  • the longitudinal display also known as an image longitudinal display or ILD
  • the longitudinal display includes a frame indicator/direction indicator 760, which indicates both the position of the displayed tomographic image 710 and the clock angle at which it is being displayed. This clock angle is also indicated by an angle indicator 770 overlaid on the tomographic image 710.
  • FIG. 8 is a screen display 800 of an example intraluminal imaging system 100, according to aspects of the present disclosure.
  • the screen display 800 includes a tomographic image 710 of the blood vessel 120, along with the estimated lumen boundary 730, measurements 740, and ILD angle indicator 770. Also visible is a co-registered X-ray image 810, that includes a highlighted region 820 of the blood vessel 120.
  • the estimated lumen boundary 730 and lumen measurements 740 may become inaccurate, inconsistent, or unreliable in the presence of a side vessel branching from the blood vessel 120.
  • it may be generally undesirable to place a stent across a side branch 825, or in the immediate vicinity of one.
  • some side branches 825 may be hidden. It is therefore an object of the present disclosure to provide a longitudinal display or ILD 750 or 850 in which side branches 825 are visible regardless of the clock angle at which they occur.
  • Figure 9A is a perspective view of a volume of intravascular imaging data 900, according to aspects of the present disclosure.
  • the volume of intravascular imaging data 900 represents a 3D shape generally similar to that of the blood vessel, and includes tomographic images 910, 920, and 930 captured at a default angle of 0 degrees, indicated by a clock angle indicator 770 in each image. Also visible is a central longitudinal axis 950 of the intraluminal imaging device and/or of the main vessel through which the intraluminal imaging device is being pulled back.
  • the volume of intravascular imaging data 900 has been divided into a first display plane 955A at an angle of a degrees, a second display plane distal 955B of the first display plane 955A, at an angle of 0 degrees, and a third display plane 955C, distal of the first and second display planes, at an angle of y degrees.
  • This arrangement allows different important features of the vessel lumen 970, vessel boundary 980, surrounding tissue 720, and side branches (if any) to be displayed simultaneously on a single ILD.
  • 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.
  • the logic of flow diagrams may be shown as sequential. However, similar logic could be parallel, massively parallel, object oriented, real-time, event-driven, cellular automaton, or otherwise, while accomplishing the same or similar functions.
  • 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.
  • to generate an image longitudinal display in real time based on one or more display angles selected algorithmically based on the presence of side branches, may require tens of calculations for each individual image in the pullback sequence.
  • the method 1400 includes determining, using the blood flow imaging data, a first angle around a central longitudinal axis of the main vessel that includes the first side branch and second angle around central longitudinal axis that includes the second side branch.
  • the first angle and the second angle may be close together (e.g., less than 30 degrees apart), may be spaced apart by an acute angle (e.g., less than 90 degrees apart), or may be spaced apart by an obtuse angle (e.g., between 90 and 180 degrees apart).
  • the method is now complete.
  • Figure 15 is a schematic, diagrammatic representation, in flow diagram form, of an example image longitudinal display generation method 1500, according to at least one embodiment of the present disclosure.
  • Method 1500 can be an example of step 1330 in the method 1300 (Fig. 13).
  • step 1510 the method 1500 includes determine whether the first side branch or the second side branch is the larger of the two. This determination may be made for example based on the length/number of frames in which the side branch appears, the angle of the side branch, the transverse velocity of blood flowing into the side branch, or other blood flow image signal (amplitude/intensity/magnitude, etc.). Execution then proceeds to step 1520.
  • Figure 16 is a schematic, diagrammatic representation, in flow diagram form, of an example image longitudinal display generation method 1600, according to at least one embodiment of the present disclosure.
  • Method 1600 can be an example of step 1330 in the method 1300 (Fig. 13).
  • step 1610 the method 1600 includes averaging the first angle of the first side branch and the second angle of the second side branch to determine an average angle. Execution then proceeds to step 1620.
  • step 1620 the method 1600 includes setting the average angle as the default cross- sectional display angle for the longitudinal view or ILD. Execution then proceeds to step 1630.
  • step 1630 the method 1600 includes determining rotations for image frames containing the first side branch, the second side branch, and a transition region between the first side branch and the second side branch. Execution then proceeds to step 1640.
  • Figure 17 is a schematic, diagrammatic representation, in flow diagram form, of an example image longitudinal display generation method 1700, according to at least one embodiment of the present disclosure.
  • Method 1700 can be an example of step 1330 in the method 1300 (Fig. 13).
  • step 1710 the method 1700 includes setting the default orientation of the radial cross-sectional or tomographic images as the default cross-sectional display angle for the longitudinal view or ILD. Execution then proceeds to step 1720.
  • Example tomographic images 1250 and 1260 contain side branch 1230, which is oriented at an angle of 90 degrees relative to the default ILD display angle of 0 degrees.
  • Example tomographic image 1270 contains side branch 1240, which is oriented at an angle of 0 degrees relative to the default. Therefore, image frames in the vicinity of side branch 1230 will be displayed on the ILD at an angle of 90 degrees, and images in the vicinity of side branch 1240, or not proximate to any side branches, will be displayed on the ILD at an angle of 0 degrees. In between, there is a transition region where the display angle is gradually changed between 90 degrees and 0 degrees.
  • Figure 18B is an image longitudinal display or ILD 750 showing a sequence of tomographic image slices 960 of the vessel 120 of Figure 18A, according to aspects of the present disclosure. Visible are the vessel lumen 970, vessel boundary 980, and surrounding tissue 720 of the main vessel 1220, as well as both side branches 1230 and 1240. In order to show both side branches clearly in the same ILD 750, a first group 1810 of image slices 960, including and proximate to side branch 1230, are displayed at a cross-sectional display angle or clock angle of 90 degrees.
  • a second group 1820 of image slices 960 including and proximate to side branch 1240 (as well as image slices 960 not proximate to any side branch) are displayed at the default clock angle of 0 degrees.
  • a transition region 1830 containing seven of the image slices 960. Since the transition region 1830 must transition smoothly between a an ILD display angle or clock angle of 90 degrees and one of 0 degrees, each frame or slice 960 of the transition region 1830 must decrease the display angle or clock angle by approximately 12.8 degrees. This smooth transition provides a smooth, clinically useful appearance for the blood vessel 120 in the ILD 750.
  • the first group 1810 can be referred to as a first portion of the longitudinal cross-sectional image that is representative of a first length of the blood vessel and that provides a first longitudinal cross-sectional view of the blood vessel along a first angle.
  • the second group 1820 can be referred to as a second portion of the longitudinal cross-sectional image that is representative of a second length of the blood vessel and that provides a second longitudinal cross-sectional view of the blood vessel along a different, second angle.
  • the transition region 1830 can be a third portion of the longitudinal cross-sectional image that is between the first portion and the second portion, and that includes multiple third longitudinal cross-sectional views along multiple third angles transitioning between the first angle and the second angle.
  • the angles in, e.g., Figs. 18A and 18B can refer to the orientation or angular position of, e.g., the side branches 1230 and 1240 around the perimeter/circumference of the main vessel 1220. These angles can be considered relative to a central longitudinal axis 1802 extending along the main vessel 1220 and/or the longitudinal view 750. For example, the angles can describe rotations or angular positions around the central longitudinal axis 1802. Sometimes these angles are referred as clock angles herein.
  • Figure 19 is schematic, diagrammatic view of a transverse velocity measurement process, according to aspects of the present disclosure. Visible is the blood vessel 120, including the main vessel 1220 and a side branch 1230.
  • the intravascular or intraluminal imaging device 102 including the imaging array 124 and imaging plane or scanline 610 perpendicular to the imaging array 124.
  • the transverse velocity of the blood flow e.g., the component of the velocity that is in a radial direction, perpendicular to the longitudinal axis of the imaging device 102 can be measured.
  • the blood moves with a velocity V that is generally aligned with the longitudinal axis of the main branch 1220 and also the longitudinal axis of the imaging device 102.
  • the velocity vector of blood traveling into the side branch 1230 is angled relative to the longitudinal axis of the main vessel 1220.
  • the imaging device 102 is aligned with the longitudinal axis of the main vessel 1220 (e.g., the imaging device 102 is straight within the main vessel 1220), the imaging plane 610 is perpendicular to the longitudinal axis of the main vessel 1120.
  • the velocity vector of blood traveling within the side branch 1230 can be defined by an angle 0 relative to the imaging plane or scanline 610.
  • the right side of the imaging array 124 that is facing the side branch 1230 will measure a transverse velocity Vt that is approximately equal to the blood velocity V times the cosine of 0.
  • angle 0 is greater than 0° and less than 90° such that the cosine of 0 is positive. Because the blood velocity within the side branch 1230 has a transverse/horizontal component, the transverse velocity Vt will be greater than 0.
  • the measured transverse velocity may still be zero, or approximately zero, or in any case significantly less than the transverse velocity Vt that is measured in the direction of the side branch 1230.
  • the tangential velocity measurements made by the imaging array 124 can not only detect the presence of the side branch 1230, but its clock angle relative to the imaging array as well.
  • the position and angle of the side branch 1230 relative to the main vessel 1120 that is illustrated in Fig. 19 is exemplary.
  • the transverse velocity should be non-zero.
  • the cosine of 0 is positive from 270° (-90°) ⁇ 0 ⁇ 90°.
  • the Vt on the right side of the imaging array 124 will be positive at various values of 0 other than the one illustrated in Fig.
  • first region and the second region are part of the same longitudinal cross-sectional image or sequence of tomographic images from the same pullback, not from external views or from separate pullbacks.
  • the processor and/or processor circuit can use radial velocities measured by each element or group of elements of the imaging array to determine the longitudinal and/or circumferential location of one or multiple side branches using a classical approach (e.g., thresholding) and/or a neural network. Other features besides side branches may also be detected, including but not limited to dissections, malappositions (e.g., stent), etc.
  • the angle 0 can also be representative of the angle at which the side branch 1230 extends from the main vessel 1220.
  • the side branch 1230 can be described by multiple angles that are different from one another.
  • the side branch can have an angular location around the perimeter/circumference of the main vessel 1220 (also referred to herein as a clock angle).
  • the side branch can extend at an angle 0 relative to the main vessel 1220.
  • FIG 20 is schematic, diagrammatic view of a transverse velocity measurement process, according to aspects of the present disclosure. Visible is the blood vessel 120, including the main vessel 1220 and a side branch 1230. Also visible is the intravascular or intraluminal imaging device 102, including the imaging array 124 and imaging plane or scanline 610 perpendicular to the imaging array 124. However, in the example shown in Figure 20, the imaging plane is located in the region 1910 of the main vessel 1220 where the blood moves with a velocity V that is generally aligned with the longitudinal axis of the main branch 1220 and also the longitudinal axis of the imaging device 102.
  • the imaging plane 610 is perpendicular to the longitudinal axis of the main vessel 1120.
  • the measured transverse velocity may be approximately zero on the left side and right side of the array 124.
  • transverse velocity Vt is approximately equal to the blood velocity V times the cosine of the angle 0 (defined relative to the imaging plane or scanline 610), which is 90° in Fig. 20.
  • the transverse velocity Vt is zero because the cosine of 90° is zero.
  • FIG. 21 is schematic, diagrammatic view of a transverse velocity measurement process, according to aspects of the present disclosure. Visible is the blood vessel 120, including the main vessel 1220 and a side branch 1230. Also visible is the intravascular or intraluminal imaging device 102, including the imaging array 124 with an imaging plane or scanline 610 perpendicular to the imaging array 124. However, in the example shown in Figure 21, the device 102 is tilted with respect to the longitudinal axis of the main vessel 1220. Because the device 102 is titled, the velocity vector V of blood in the region 1910 has a transverse/horizontal component Vt left on the left side of the array 124 and a transverse/horizontal component Vt right on the right side of the array 124. Fig.
  • the velocity vector of blood forms an angle ⁇ left with respect to the imaging plane or scanline 610 on the left side and an angle Oright with respect to the imaging plane or scanline 610 on the right side.
  • the transverse velocity has a negative value Vt left on the left side of the imaging array 124 (because angle Oieft is between 90° and 180°, and the cosine of Oieft is negative) and a positive value Vt right on the right side of the imaging array 124 (because angle Oright is between 0° and 90°, and the cosine of Oright is positive).

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Abstract

Un appareil comprend un circuit processeur conçu pour une communication avec un cathéter d'imagerie intravasculaire. Le circuit processeur est configuré pour : commander le cathéter d'imagerie intravasculaire pour obtenir des données d'imagerie intravasculaire d'un vaisseau sanguin tandis que le cathéter d'imagerie intravasculaire est déplacé à travers le vaisseau sanguin ; générer une image en coupe longitudinale du vaisseau sanguin sur la base de données d'imagerie intravasculaire ; et délivrer, à un dispositif d'affichage en communication avec le circuit processeur, un affichage d'écran comprenant l'image en coupe longitudinale. L'image en coupe longitudinale comprend une première partie représentative d'une première longueur du vaisseau sanguin et une seconde partie différente représentative d'une seconde longueur différente du vaisseau sanguin. La première partie comprend une première vue en coupe longitudinale du vaisseau sanguin le long d'un premier angle et la seconde partie comprend une seconde vue en coupe longitudinale du vaisseau sanguin le long du second angle différent.
PCT/EP2025/058316 2024-04-01 2025-03-26 Image longitudinale intravasculaire avec partie tournée pour visualisation de branche latérale Pending WO2025209904A1 (fr)

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