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WO2025168460A1 - Imagerie intravasculaire pour planification d'endoprothèse avec visualisation et ajustement simultanés de zone de pose, - Google Patents

Imagerie intravasculaire pour planification d'endoprothèse avec visualisation et ajustement simultanés de zone de pose,

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Publication number
WO2025168460A1
WO2025168460A1 PCT/EP2025/052568 EP2025052568W WO2025168460A1 WO 2025168460 A1 WO2025168460 A1 WO 2025168460A1 EP 2025052568 W EP2025052568 W EP 2025052568W WO 2025168460 A1 WO2025168460 A1 WO 2025168460A1
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WO
WIPO (PCT)
Prior art keywords
stent
virtual stent
intravascular
blood vessel
screen display
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/EP2025/052568
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English (en)
Inventor
Kellen Scott MOULTON
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
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Publication date
Application filed by Koninklijke Philips NV filed Critical Koninklijke Philips NV
Publication of WO2025168460A1 publication Critical patent/WO2025168460A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • 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
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/10—Computer-aided planning, simulation or modelling of surgical operations
    • 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
    • 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
    • A61B8/46—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
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/40—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H30/00—ICT specially adapted for the handling or processing of medical images
    • G16H30/40—ICT specially adapted for the handling or processing of medical images for processing medical images, e.g. editing
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
    • A61B6/12—Arrangements for detecting or locating foreign bodies
    • 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
    • A61B8/4416—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to combined acquisition of different diagnostic modalities, e.g. combination of ultrasound and X-ray acquisitions
    • 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
    • A61B8/465—Displaying means of special interest adapted to display user selection data, e.g. icons or menus
    • 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

Definitions

  • the present disclosure relates generally to intravascular imaging (e.g., intravascular ultrasound (IVUS), optical coherence tomography (OCT), etc.) using an intravascular imaging catheter for planning a location for placement of an intravascular stent.
  • intravascular imaging e.g., intravascular ultrasound (IVUS), optical coherence tomography (OCT), etc.
  • IVUS intravascular ultrasound
  • OCT optical coherence tomography
  • a user can move a virtual stent without changing its length, such that the intravascular images at both ends of the virtual stent are simultaneously updated to reflect the current position of the virtual stent.
  • Intravascular imaging (such as intravascular ultrasound (IVUS) or optical coherence tomography (OCT) 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 IVI 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 IVI (e.g., IVUS or OCT) imaging system.
  • IVI e.g., IVUS or OCT
  • the imaging system processes the received ultrasound echoes to produce a cross-sectional image of the vessel where the device is placed.
  • 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, to counteract the effects of an occlusion, plaque, or compression.
  • 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.
  • a physician can use IVI to find diseased segments of the vessel.
  • a physician uses this information to decide what length of stent to place in the vessel to cover the lesion, and where within the vessel to place it.
  • the planned location for stent placement includes two endpoints: a proximal reference frame or landing zone, and a distal reference frame or landing zone, representing the two ends of the stent.
  • IVI software allows for users to move one end (e.g., the proximal or distal reference frame) of a segment at a time. This is useful for finding a lesion, and for finding one healthy landing zone at a time.
  • stents do not come in all lengths, and may for example be available in 2 mm or 5 mm increments. The user must therefore select locations within the vessel for each landing zone, such that the minimum lumen area occurs between the landing zones, such that the distance between the landing zones is equal to the length of an actual stent currently available in the catheterization lab, and such that the vessel area and/or plaque burden at both landing zones is approximately equal. This places a substantial burden on the user, in the midst of an intravascular the procedure, when time is of the essence.
  • the stent placement planning system can simultaneously translate both the proximal and distal reference frames or landing zones (the proximal and distal ends of the virtual stent), such that movement of one reference frame or landing zone corresponds to an equal movement of the other reference frame or landing zone. This has the effect of moving the entire virtual stent (both the proximal and distal reference frames/landing zones) along the vessel in a proximal or distal direction.
  • the intravascular images at the proximal and distal reference frames or landing zones are simultaneously updated to reflect the views at the current location of the proximal and distal ends of the stent end. The user can move the virtual stent to a desirable location.
  • the stent placement planning system has particular but not exclusive utility for intravascular imaging of blood vessels with impeded blood flow (blocked by plaque, compressed by other anatomy, etc.) before stenting, to determine the size of stent to be used and the location where the stent will be placed.
  • Figure 1 is a diagrammatic schematic view of an intraluminal imaging system, according to aspects of the present disclosure.
  • Figure 2 is a schematic diagram of a processor circuit, according to aspects of the present disclosure.
  • Figure 3 illustrates a blood vessel incorporating a plaque, according to aspects of the present disclosure.
  • Figure 6 is a stent planning screen display of an example stent placement planning system, according to aspects of the present disclosure.
  • Figure 14C is a close-up view of the annotated angiographic image of Figure 8, showing the 15 mm virtual stent in the second position within the blood vessel, according to aspects of the present disclosure.
  • Figure 18 is a screen display of an example stent placement planning system, according to aspects of the present disclosure.
  • Figure 19 is a screen display of an example stent placement planning system, according to aspects of the present disclosure.
  • Figure 20 is a screen display of an example stent placement planning system, according to aspects of the present disclosure.
  • the virtual stent can be displayed in a desired area of a 2D or 3D depiction of vessel, as part of a physician planning the deployment of stent before the actual/real stent is positioned inside the actual/real vessel of the patient.
  • the longitudinal view can be generated based on the intravascular imaging data itself (e.g., an imagebased ILD) or measurements/statistics from the intravascular imaging data (e.g., vessel diameter, lumen diameter, vessel cross-sectional area, lumen cross-sectional area, etc., for a graphical ILD).
  • the stent placement planning system includes a software feature that helps the operator to plan the landing zones of a stent of a given length.
  • a diseased segment is identified within a vessel by an IVI image interpretation system
  • three image frames may be identified: a proximal reference frame, a minimum lumen area frame, and a distal reference frame.
  • the proximal and distal reference frames can be used as landing zones for the proximal and distal ends of a stent.
  • these frames are separated by a non-integer distance that does not correspond to the length of real stents.
  • the stent placement planning system includes a user interface (UI) capable of touch input or click input on an IVI ILD of a vessel (e.g., and IVUS or OCT image longitudinal display), or on an associated angiography X-ray image of the vessel, to select and move the endpoints of a diseased segment to create a virtual stent, and to move the virtual stent along the vessel to a desired location.
  • UI user interface
  • the physician or software finds a lesion to be 16.4mm in length, the physician may select an 18mm stent to fully cover the lesion.
  • the stent placement planning system helps the physician plan the placement of that 18mm stent.
  • the user can adjust one end of that 16.4mm segment at a time. If the user wants to see both landing zones, they can extend one end of that 16.4mm segment so that it is 18mm. With such systems, the two landing zones are the correct length apart, but the position is not optimized. If the user wants to move the position of the segment in software to be more proximal or more distal, then the two ends of the segment need to be adjusted individually.
  • the segment can represent an 18mm stent, and the whole segment can move more proximal or more distal. Doing so allows the user to see both landing zones (e.g., both ends of that segment) at the same time, helping the user to find the safest location to place the landing zones for the stent.
  • the stent placement planning system includes a visual representation of a segment of interest within a recorded IVI pullback, with a proximal and distal end, in the software.
  • this may be a visual representation of a lesion, the span of a lesion, or a stent.
  • the initial length of the segment of interest can be known or pre-determined. This may for example include IVI pullback data with known length between the recorded frames (meaning if two IVI frames were recorded at some distance apart in the vessel, the system can know or determine what that distance is). The length could have been measured (e.g., with a pullback motor encoder), calculated, or estimated.
  • the stent placement planning system allows the user to set the length of the segment of interest to be the length of a stent. This can be done either by entering the length into the system, or adjusting one end of the segment of interest until it is the correct length.
  • the stent placement planning system is well-suited to be part of any IVI interpretation software where two ends of a segment can be manipulated independently.
  • the stent placement planning system includes software to be that ties the two ends of a segment together with a fixed length. This is useful for planning the landing zones of a stent.
  • the devices, systems, and methods described herein can include one or more features described in U.S. Provisional App. No. 63/600,110, filed November 17, 2023, which is hereby incorporated by reference in its entirety as though fully set forth herein.
  • 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 stent placement planning system has particular but not exclusive utility for ultrasound imaging of occluded blood vessels before stenting, to determine the size of stent to be used and the location where the stent will be placed.
  • the present disclosure aids substantially in the real-time planning of stent placement during an interventional intravascular procedure, by allowing the user to create and move a virtual stent within the vessel.
  • a processor such as a patient interface module (PIM)
  • PIM patient interface module
  • the stent placement planning system disclosed herein provides practical improvements in the treatment of vascular diseases.
  • This improved stent placement planning technique transforms a largely manual process that is dependent on expertise, dexterity, and time 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 stent sizes and landing zones are selected.
  • the stent placement planning 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 an intraluminal (e.g., intravascular) imaging device.
  • the control process performs certain specific operations in response to different inputs or selections made at different times.
  • Certain outputs of the stent placement planning system may be printed, shown on a display, or otherwise communicated to human operators.
  • FIG. 1 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 aspects.
  • 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 aspects.
  • 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 non-imaging 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 aspects, 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 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 vessel diameters 472 and 476 at the distal and proximal references, respectively, may be larger than the vessel diameters 372 and 376 of Figure 3, and the vessel diameter 474 at the target frame (or former MLA) may be substantially larger than the vessel diameter 374 of Figure 3.
  • Figure 7 is a stent planning screen display 700 of an example stent placement planning system 510, according to aspects of the present disclosure.
  • the user has used a pointer 710 (e.g., a mouse pointer with a click- and-drag input, or a touch screen with a touch-and-drag input) to grab the virtual stent 660 and drag it in a distal direction 720 from a first position to a second position.
  • the pointer 710 the user can grab and move the virtual stent in either the angiographic image 530 or the ILD 540.
  • the annotated angiographic image 530 can now be used as a roadmap or stent placement plan 830, with the virtual stent 660 being shown in the desired location within the blood vessel 300.
  • the proximal and distal image frames 554 and 556, and the corresponding numerical statistics 574 and 576, have changed from Fig. 7 to 8 because these automatically update to reflect the current location of the proximal landing zone 546 and the distal landing zone 544 of the virtual stent 660.
  • the target location 555 did not move (and the target frame 555 and corresponding statistics 575 did not change) from Fig. 7 to Fig. 8.
  • the target location 555 did not move (and the target frame 555 and corresponding statistics 575 did not change) from Fig. 8 to Fig. 9 because the target location 555 is located within both the 15 mm virtual stent (Fig. 8) and the 12 mm virtual stent (Fig. 9).
  • a delivery catheter 1010 is visible in the fluoroscopic image 1030, following the contours of the blood vessel 300. Near the distal end of the delivery catheter 1010 is a physical (e.g., non-virtual) stent 440, which is being delivered into the diseased portion of the blood vessel 300.
  • a physical (e.g., non-virtual) stent 440 which is being delivered into the diseased portion of the blood vessel 300.
  • the method 1100 includes identifying a diseased segment of the blood vessel (e.g., a segment containing a plaque or other lesion), by identifying a proximal reference frame, target frame, and distal reference frame. This may for example include calculating the lumen dimensions based on the lumen border and/or the lumen area.
  • aspects of the present disclosure can include features described in U.S. Publication No. 2007/0201736, U.S. Patent No. 11,272,845, U.S. Patent No. 7,463,759, U.S. Patent No. 9,295,447, U.S. Patent No. 11,744,527, U.S. Publication No. 2020/0029932, U.S. Publication No. 2019/0282211, each of which is hereby incorporated by reference as though fully set forth herein. Execution then proceeds to step 1115.
  • step 1115 the method 1100 includes outputting a screen display that includes: 1) a visual representation of the vessel, with the identified lesion segment overlaid on the visual representation, and 2) intravascular images of the proximal reference frame, target frame, and distal reference frame. Execution then proceeds to step 1120.
  • step 1125 the method 1100 includes updating the screen display such that the virtual stent is overlaid at a first position on the visual representation of the vessel, and such that the intravascular images are of the proximal landing zone (first position), target frame, and distal landing zone (second position). Execution then proceeds to step 1130.
  • step 1130 the method 1100 includes receiving a user input to move the virtual stent from the first position to a different, second position on the visual representation, without changing the length of the virtual stent. Execution then proceeds to step 1135.
  • step 1135 the method 1100 includes updating the screen display such that the virtual stent is overlaid at the second position on the visual representation of the vessel, and such that the intravascular images are of the proximal landing zone (second position), target frame, and distal landing zone (second position). If the user is satisfied with the positioning of the stent, the screen display, or portions thereof, can now serve as a stent planning or roadmap display. Execution them proceeds to step 1140.
  • step 1140 the method 1100 includes determining whether the user desires to change the virtual stent length. If yes, execution then proceeds to step 1145. If no, execution proceeds to step 1150.
  • step 1145 the method 1100 includes receiving a user input to change the virtual stent length (e.g., to stent length #2, stent length #3, etc.). Execution then returns to step 1125.
  • step 1150 the method 1100 includes performing stent placement based on the stent planning. Step 1150 includes substeps 1155 and 1160.
  • 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.
  • FIG. 12A is a close-up view of the ILD 540 from Figure 6, according to aspects of the present disclosure.
  • the virtual stent 660 is in a first location.
  • the distal landing zone 544, target frame 580, and proximal landing zone 546 along with the proximal handle 620 that can be used to resize the virtual stent 660 by moving the proximal landing zone 546, and the distal handle 630 that can be used to resize the virtual stent 660 by moving the distal landing zone 544.
  • the user By clicking and dragging on the virtual stent 660 itself, the user can move the virtual stent 660 without resizing it, by moving both the distal landing zone 544 and the proximal landing zone 546 in synchrony.
  • Figure 12C is a close-up view of the ILD from Figure 8, according to aspects of the present disclosure.
  • the virtual stent 660 has been moved to a second location that is favorable for stent placement as described above in Figure 8. Visible are the distal landing zone 544, target frame 580, and proximal landing zone 546, along with the proximal handle 620 and distal handle 630.
  • Figure 13A is a close-up view of the tomographic image display area 550 from Figure 6, according to aspects of the present disclosure.
  • the virtual stent is in a first location.
  • Representing the distal landing zone are a tomographic image 554, annotated with the vessel border 1310 and lumen border 1320, as well as vessel metrics 574.
  • Representing the target frame are a tomographic image 555 vessel border 1330, lumen border 1340, and vessel metrics 575.
  • Representing the proximal landing zone are a tomographic image 556, vessel border 1350, lumen border 1360, and vessel metrics 576.
  • the distal landing zone plaque burden 640 is 43.5%, but the proximal landing zone plaque burden 650 is 72.8%, indicating that the first position is not suitable for stent placement.
  • Figure 13C is a close-up view of the tomographic image display area 550 from Figure 8, according to aspects of the present disclosure.
  • the virtual stent has been moved from the first location to the more distal second location, and has stopped moving.
  • the frame number 1370 of the distal landing zone tomographic image 554 is lower than in Figures 13 A and 13B, and the frame number 1390 of the proximal landing zone tomographic image 556 is by the same amount, such that the size of the virtual stent has not changed.
  • the distal landing zone plaque burden 640 is 46.1%
  • the proximal landing zone plaque burden 650 is 45.0%, indicating that the virtual stent has arrived at a suitable location as described above.
  • Figure 14A is a close-up view of the annotated angiographic image 530 of Figure 6, showing the 15 mm virtual stent 660 in the first position within the blood vessel 300, according to aspects of the present disclosure. Also visible are the target frame 580, along with the proximal handle 620 and distal handle 630, either of which can be grabbed (e.g., clicked-and- dragged, touched-and-dragged, etc.) and moved in order to resize the virtual stent. Grabbing and dragging any other portion of the virtual stent 660 allows the user to move the virtual stent proximally or distally within the blood vessel 300.
  • Figure 14B is a close-up view of the annotated angiographic image 530 of Figure 7, showing the 15 mm virtual stent 660 being moved within the blood vessel 300 in a distal direction 720, according to aspects of the present disclosure.
  • a pointer 710 has grabbed the virtual stent 660, and the handles 620, 630 have changed color to signify the fact that the virtual stent 660 is being moved.
  • Other visual indicators of movement may be used instead or in addition.
  • Figure 14C is a close-up view of the annotated angiographic image 530 of Figure 8, showing the 15 mm virtual stent 660 in the second (more distal) position within the blood vessel 300, according to aspects of the present disclosure. Also visible are the target frame 580, along with the proximal handle 620 and distal handle 630, which have reverted to their original color now that the virtual stent is no longer moving. The target location 580 did not move when the virtual stent 660 moved because the target location 580 is still positioned within proximal and distal ends of the virtual stent 660.
  • Figure 15 is a screen display 1500 of an example stent placement planning system 510, according to aspects of the present disclosure.
  • the coregistered angiographic image is not shown
  • the vessel and lumen borders are not shown in the tomographic images 554, 555, and 556
  • the ILD 540 is an image-based ILD (e.g., constructed from the IVI images) rather than a graphical ILD.
  • the screen display 1500 otherwise retains the same or similar functionality to other screen displays shown above. For example, the user can still grab and move the virtual stent 660 or vessel segment 520 without changing its length.
  • Figure 16 is a screen display 1600 of an example stent placement planning system 510, according to aspects of the present disclosure.
  • the vessel metrics are not shown.
  • the length 560 of the virtual stent 660 or vessel segment 520 is still shown.
  • the length is a distance measurement that relies on a known distance between images within the IVI pullback. This may be accomplished for example by pulling back the imaging catheter at a known speed (e.g., with a pullback device or sled), or by estimating the speed of the pullback or the distance between successive frames based on the anatomy of the blood vessel.
  • the screen display 1600 otherwise retains the same or similar functionality to other screen displays shown above.
  • Figure 17 is a screen display 1700 of an example stent placement planning system 510, according to aspects of the present disclosure.
  • Figure 17 is similar to Figure 16, except that the distance measurement has also been removed. This represents a highly simplified visualization of the stent placement planning system 510, wherein the user can still grab and move the virtual stent 660 or vessel segment 520 without changing its length, but much of the associated information is not displayed.
  • Figure 18 is a screen display 1800 of an example stent placement planning system 510, according to aspects of the present disclosure.
  • the user is in the midst of resizing the virtual stent 660 (e.g., from 12 mm to 15 mm, passing transiently through a value of 13.1 mm).
  • a pointer 710 has grabbed the proximal handle 620 in the angiographic image 530 and the ILD 540 in order to move the proximal reference frame or landing zone 546, without moving the distal reference frame or landing zone 544.
  • the proximal handle has changed color vs the proximal handle 630 in both the angiographic image 530 and the ILD 540 to denote the fact that the proximal reference frame or landing zone is moving.
  • Figure 19 is a screen display 1900 of an example stent placement planning system 510, according to aspects of the present disclosure.
  • the user has clicked on the proximal reference tomographic image 556.
  • This has changed the display screen in several ways.
  • a scrubber 1910 has moved to the location of the proximal image frame 546 in both the co-registered angiographic image 530 and the ILD 540.
  • the proximal reference tomographic image 556 has become larger, and the target and distal reference tomographic images have disappeared.
  • the vessel segment 520 or virtual stent 660 can still be seen in the ILD and the angiographic image, but is no longer highlighted, to denote the fact that it is not currently being viewed.
  • Figure 20 is a screen display 2000 of an example stent placement planning system 510, according to aspects of the present disclosure.
  • the user is using a pointer 710 to click and drag the scrubber 1910 to a frame located inside the vessel segment 520 or virtual stent 660.
  • the frame number 2010 and tomographic image 2020 change to represent different frames in the I VI pullback sequence. This can be useful for example so that a clinician can examine the entire length of a diseased segment to obtain a better understanding of the vessel geometry.
  • Figure 21 is a screen display 2100 of an example stent placement planning system 510, according to aspects of the present disclosure.
  • both the diseased vessel segment 520 and the virtual stent 660 are visible at the same time, in both the angiographic image 530 and the ILD 540.
  • This can be useful for example so that the clinician can verify that the diseased segment falls entirely within the virtual stent, and so that the clinician can better understand the context for stent placement decisions.
  • This also allows the user to move or resize the virtual stent 660 without affecting the size or position of the vessel segment 520.
  • the stent placement planning system advantageously permits the users of intraluminal imaging systems to determine the appropriate size and landing zones for a stent, with enhanced speed, accuracy, and repeatability.
  • 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.
  • the stent placement planning system’s workflow with the GUI interface may be highly visible.
  • This technology could be applied to percutaneous coronary intervention or peripheral endovascular intervention, and may be useful not only for stent planning but for planning and deployment of other therapies used in these types of interventional procedures.
  • any type of angioplasty device, atherectomy device, or drug delivery device of a known length could potentially benefit from this type of IVI planning software.
  • 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 a system including a processor circuit configured for communication with an intravascular imaging catheter, where the processor circuit is configured to: control the intravascular imaging catheter to obtain a plurality of intravascular images while the intravascular imaging catheter is moved through a blood vessel of a patient; output a screen display for stent planning, where the screen display may include: a visual representation of the blood vessel; a virtual stent overlaid in a first position on the visual representation, where the virtual stent may include a proximal end, a distal end, and a length extending between the proximal end and the distal end; receive first user input to move the virtual stent from the first position to a different, second position on the visual representation; and update the screen display in response on the first user input such that the screen display may include: the visual representation of the blood vessel: the virtual stent overlaid in the second position on the visual representation, where the first user input does not change the length of the virtual stent such that the length of the virtual stent is the
  • Implementations may include one or more of the following features.
  • the length of the virtual stent is the same: in the first position; in the second position; and while the virtual stent moves from the first position to the second position.
  • the processor circuit is configured to receive a second user input to change a lesion segment overlaid on the visual representation to the virtual stent.
  • the second user input may include a first value of the length of the virtual stent.
  • the length of the virtual stent is different than a length of the lesion segment.
  • the length of the stent may include only integer values, and the length of the lesion segment may include non-integer values and the integer values.
  • the length of the virtual stent may include a first value
  • the processor circuit is configured to: receive a third user input to change the length of the virtual stent to be a different, second value; and repeat the receiving the first user input and the updating the screen display in response to the first user input with the second value of the length of the virtual stent.
  • the virtual stent comprises a proximal end and a distal end, and the length of the virtual stent extends between the proximal end and the distal end.
  • the first user input received on the virtual stent between the proximal end and the distal end of the virtual stent.
  • the processor circuit is configured to update the screen display such that a visual appearance of the proximal end and the distal end of the virtual stent is changed while the first user input is being received. In some aspects, the processor circuit is configured to receive a fourth user input to change a length of the virtual stent, where the fourth user input is received on the proximal end or the distal end of the virtual stent.
  • the processor circuit when the fourth user input is received on the proximal end of the virtual stent, the processor circuit is configured to update the screen display such that a visual appearance of the proximal end of the virtual stent is changed while the fourth user input is being received, where, when the fourth user input is received on the distal end of the virtual stent, the processor circuit is configured to update the screen display such that a visual appearance of the distal end of virtual stent is changed while the fourth user input is being received.
  • the screen display may include: a first area associated with a proximal landing zone of the virtual stent and may include one of the plurality of intravascular images corresponding to the proximal end of the virtual stent; and a second area associated with a distal landing of the virtual stent and may include one of the plurality of intravascular images corresponding to the proximal end of the virtual stent.
  • the first area and the second area change based on a current position of the virtual stent while the virtual stent moves from the first position to the second position.
  • the first area may include a first value of a metric associated with at least one of the blood vessel or a lumen of the blood vessel
  • the second area may include a second value of the metric associated with at least one of the blood vessel or the lumen of the blood vessel.
  • the first value of the metric and the second value of the metric change based on a current position of the virtual stent while the virtual stent moves from the first position to the second position.
  • One general aspect includes system, comprising: a processor circuit configured for communication with an intravascular imaging catheter, wherein the processor circuit is configured to: control the intravascular imaging catheter to obtain a plurality of intravascular images while the intravascular imaging catheter is moved through a blood vessel of a patient; output a screen display comprising: a vessel segment indicator overlaid on a visual representation in a first position, wherein the vessel segment indicator comprises a proximal end and a distal end; and a first intravascular image and a second intravascular image respectively associated with the proximal end and the distal end of the vessel segment indicator in the first position; and receive a user input to move the vessel segment indicator from the first position to a different second position; update the screen display in response to the user input such that the screen display comprises: the vessel segment indicator overlaid on the visual representation in the second position; and a third intravascular image and a fourth intravascular image respectively associated with the proximal end and the distal end of the vessel segment indicator in the second position, wherein the first intravascular imaging catheter
  • One general aspect includes a system that includes an intravascular imaging catheter; and a processor circuit configured for communication with the intravascular imaging catheter, where the processor circuit is configured to: control the intravascular imaging catheter to obtain a plurality of intravascular images depicting a plurality of locations along a blood vessel of a patient while the intravascular imaging catheter is moved through the blood vessel, where the plurality of intravascular images may include a first intravascular image, a second intravascular image, a third intravascular image, and a fourth intravascular image; output a screen display for stent planning, where the screen display may include: a visual representation of the blood vessel; a virtual stent overlaid in a first position on the visual representation, where the virtual stent may include a proximal end, a distal end, and a length extending between the proximal end and the distal end; a first area associated with a proximal landing zone of the virtual stent, where the first area may include the first intravascular image, where the first intravascular image depicts

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Abstract

Un système comprend un circuit de processeur configuré pour commander un cathéter d'imagerie intravasculaire en vue d'obtenir des images intravasculaires pendant que le cathéter est déplacé à travers un vaisseau sanguin d'un patient, et fournir un affichage sur écran permettant la planification d'endoprothèse. L'affichage sur écran comprend une représentation visuelle du vaisseau sanguin et d'une endoprothèse virtuelle superposée dans une première position sur la représentation visuelle. Le circuit de processeur reçoit une première entrée d'utilisateur servant à déplacer l'endoprothèse virtuelle de la première position à une seconde position différente sur la représentation visuelle, et met à jour l'affichage sur écran. L'affichage sur écran mis à jour comprend la représentation visuelle du vaisseau sanguin et de l'endoprothèse virtuelle superposée dans la seconde position sur la représentation visuelle. La longueur de l'endoprothèse virtuelle est la même dans la première position, dans la seconde position, et pendant que l'endoprothèse virtuelle se déplace de la première position à la seconde position.
PCT/EP2025/052568 2024-02-07 2025-01-31 Imagerie intravasculaire pour planification d'endoprothèse avec visualisation et ajustement simultanés de zone de pose, Pending WO2025168460A1 (fr)

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