Intravascular imaging-based comparison of stent length and location options

Abstract

An apparatus includes a processor configured for communication with an intravascular imaging catheter and a display. The processor controls the catheter to obtain intravascular images while the catheter is moved through a blood vessel including a lesion. The processor generates, based on the images, a comparison view for planning a stent to provide treatment for the lesion including a first stent option area and a second stent option area displayed simultaneously on the display. The first stent option area includes a visual representation of the blood vessel, a first virtual stent with a first length, intravascular images or metrics associated with the first stent length. The second stent option area includes the visual representation of the blood vessel, a second virtual stent overlaid on the visual representation and comprising a different, second length; and intravascular images or metrics associated with the second stent length.

Description

Docket No. 2024PF00151INTRAVASCULAR IMAGING-BASED COMPARISON OF STENT LENGTH AND LOCATION OPTIONSTECHNICAL FIELD

[0001] The present disclosure relates generally to intravascular imaging (e.g., intravascular ultrasound (IVUS), optical coherence tomography (OCT), etc.) using an intravascular imaging catheter for determining size and location for placement of an intravascular stent. In particular, the stent placement comparison system compares two available stent lengths and locations capable of covering a lesion.BACKGROUND

[0002] Intravascular imaging (IVI) (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. The imaging system processes the received ultrasound echoes to produce a cross-sectional image of the vessel where the device is placed.

[0003] Peripheral and coronary vascular procedures, such as stenting, often involve IVI. 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, and selecting the size of the 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.

[0004] For example, during the procedure, 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 stentDocket No. 2024PF00151 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.

[0005] Currently, physicians using intravascular imaging must make stenting decisions through a largely manual process of image assessment. This process involves taking inventory of their stent options (e.g. size and length), and matching their available stents to the observed length and morphology of any detected lesions. This can be a lengthy process with a variety of considerations that takes a significant portion of time during a procedure. Additionally, suboptimal or incorrect stent selection and placement can pose significant risk to the health and safety of patients. In short, this is a crucial part of percutaneous coronary intervention (PCI) that can often take significant time and poses significant risk.

[0006] Furthermore, clinicians may want to balance two sometimes-competing objectives: 1) place the stent so that the two ends are in the healthiest possible locations, and 2) minimize the stent length (the amount of metal) placed in the patient’s vessel. This tradeoff can place a substantial burden on the user, in the midst of an intravascular procedure, when time is of the essence.

[0007] The information included in this Background section of the specification, including any references cited herein and any description or discussion thereof, is included for technical reference purposes only and is not to be regarded as subject matter by which the scope of the disclosure is to be bound.Docket No. 2024PF00151SUMMARY

[0008] Stent placement comparison systems, devices, and methods are provided for intravascular imaging (e.g., intravascular ultrasound or IVUS, optical coherence tomography or OCT, etc.). The stent placement comparison system shows, simultaneously on the same screen, two different stenting options for the same lesion, including appropriate vessel and lumen metrics (e.g., plaque burden) for determining the efficacy of the stent at different locations. The selectable options may include different stent lengths, different landing zones, or a combination thereof. The stent placement comparison 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.

[0009] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to limit the scope of the claimed subject matter. A more extensive presentation of features, details, utilities, and advantages of the stent placement comparison system, as defined in the claims, is provided in the following written description of various aspects of the disclosure and illustrated in the accompanying drawings.Docket No. 2024PF00151BRIEF DESCRIPTION OF THE DRAWINGS

[0010] Illustrative aspects of the present disclosure will be described with reference to the accompanying drawings, of which:

[0011] Figure 1 is a diagrammatic schematic view of an intraluminal imaging system, according to aspects of the present disclosure.

[0012] Figure 2 is a schematic diagram of a processor circuit, according to aspects of the present disclosure.

[0013] Figure 3A illustrates a blood vessel incorporating a plaque, according to aspects of the present disclosure.

[0014] Figure 3B illustrates a blood vessel incorporating a plaque and with a stent expanded inside it to restore flow, according to aspects of the present disclosure.

[0015] Figure 4A illustrates a blood vessel incorporating a plaque, according to aspects of the present disclosure.

[0016] Figure 4B illustrates a blood vessel incorporating a plaque and with a stent expanded inside it to restore flow, according to aspects of the present disclosure.

[0017] Figure 5 is a screen display of an example stent placement comparison system, according to aspects of the present disclosure.

[0018] Figure 6 is a screen display of an example stent placement comparison system, according to aspects of the present disclosure.

[0019] Figure 7 is a schematic, diagrammatic representation, in flow diagram form, of an example stent placement comparison method, according to aspects of the present disclosure.

[0020] Figure 8 is a schematic, diagrammatic representation, in block diagram form, of an example stent placement comparison system, according to aspects of the present disclosure.

[0021] Figure 9 is a screen display of an example stent placement comparison system, according to aspects of the present disclosure.

[0022] Figure 10 is a schematic, diagrammatic representation, in block diagram form, of an example determination of available stent lengths to show the user.

[0023] Figure 11 is a screen display of an example stent placement comparison system, according to aspects of the present disclosure.

[0024] Figure 12 is a screen display of an example stent placement comparison system, according to aspects of the present disclosure.Docket No. 2024PF00151

[0025] Figure 13 is a screen display of an example stent placement comparison system, according to aspects of the present disclosure.

[0026] Figure 14 is a schematic, diagrammatic representation, in block diagram form, of three different types of user input, according to aspects of the present disclosure.

[0027] Figure 15 is a schematic, diagrammatic representation of a co-registered image screen display, according to aspects of the present disclosure.

[0028] Figure 16 is a screen display for switching back and forth between two different stent options, according to aspects of the present disclosure.

[0029] Figure 17 is a screen display for switching back and forth between two different lesions, according to aspects of the present disclosure.

[0030] Figure 18 is a screen display showing three co-registered views of the blood vessel 300, according to aspects of the present disclosure.

[0031] Figure 19 is a screen display showing three co-registered views of the blood vessel 300, according to aspects of the present disclosure.

[0032] Figure 20 is a screen display showing exemplary placement of the first selected stent length 2010, according to aspects of the present disclosure.

[0033] Figure 21 is a screen display showing three co-registered views of the blood vessel 300, according to aspects of the present disclosure.

[0034] Figure 22 is a screen display showing three co-registered views of the blood vessel 300, according to aspects of the present disclosure.

[0035] Figure 23 is a lesion detail screen display showing the location and vessel / lumen metrics of a lesion 1710, according to aspects of the present disclosure.

[0036] Figure 24 is an example stent option comparison screen, according to aspects of the present disclosure.Docket No. 2024PF00151DETAILED DESCRIPTION

[0037] During an intravascular intervention procedure, 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 has two landing zones, one for each end of the stent (proximal and distal). Landing zones are typically located in healthy tissue, such as tissue with a plaque burden of less than 50%. However, physicians may want to balance two competing objectives: to place the stent so that the two ends are in the healthiest possible locations, and to minimize the stent length (e.g., the amount of metal) placed in the patient’s vessel. Today there is no simple method available on the market for quickly comparing the landing zones for multiple stent length options that a physician may be considering, or even comparing two possible landing locations for a single stent length.

[0038] In accordance with at least one aspect of the present disclosure, a stent placement comparison system is provided which provides a simultaneous visual and numerical comparison between two stent placement options for the same lesion, on the same screen. This enables a user to plan stent lengths and landing zones by, for example, comparing a given commercially available stent length with the next larger available length, to see whether the additional stent length provides sufficient benefit to justify using it. This capability can be deployed as part of automated IVI image interpretation software, or it can work independently of automated image interpretation software.

[0039] Ideally at least two options would be visible on the screen at the same time, but alternatively it could be that only one of the options is visible and the other option(s) are quickly switched between using tabs or a dropdown menu. For example, the physician might be deciding between placing a 12mm stent and a 15mm stent, and may want to see information for both options on screen.

[0040] Information displayed for each of the stent options could include: the length of the stent, intravascular imaging frames that would be present at the proximal and distal landing zones for that length of stent, a third intravascular imaging frame showing the minimum lumen area or other frame of interest. The display could also include information about each those frames such as lumen and vessel areas or diameters, plaque burden percentage, and other relevant landing zone information such as calcium and side branches. Other display items mayDocket No. 2024PF00151 include a longitudinal display of the vessel showing longitudinal intravascular imaging data or lumen, a lumen boundary, a vessel boundary, external elastic lamina (EEL), and / or plaque burden information. The screen display may also include an angiogram with the planned stent position overlaid, a way to configure the length of stent, such as a dropdown menu or manual entry, and a way to reposition the virtual stent longitudinally.

[0041] An example might include a display with the length of stent that can be selected, an angiogram with the stent position overlaid, an ability to move the position more proximal or distal, and the two IVUS frames associated with those landing zones for e.g., a 12mm stent and a 15mm stent. In some aspects, the two landing zones for each stent are automatically chosen by the system, based for example on having an equal plaque burden on the two ends of the stent, and a plaque burden of less than 50% at each end. In other aspects, the stent sizes and landing zones are selected manually, e.g. by selecting the stent sizes from a menu, and manually sliding each stent to the desired location on an image longitudinal display (ILD) or angiogram.

[0042] The devices, systems, and methods described herein can include one or more features described in U.S. Provisional App. No. , filed (Atty Dkt. No. 2023PF00152 / 44755.2422PV01), and titled “Intravascular-Imaging Based Automatic Stent Length Determination And Landing Zone Selection”, and U.S. Provisional App. No. 63 / 550,709, filed February 7, 2024, and titled “Stent Placement Planning With Intravascular Imaging And Associated Systems, Devices, And Methods”, each of which is incorporated by reference in its entirety as though fully set forth herein.

[0043] 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.

[0044] The devices, systems, and methods described herein can also include one or more features described in U.S. Provisional App. No. 62 / 642,847, filed March 14, 2018, U.S. Provisional App. No. 62 / 712,009, filed July 30, 2018, U.S. Provisional App. No. 62 / 711,927,Docket No. 2024PF00151 filed July 30, 2018, and U.S. Provisional App. No. 62 / 643,366, filed March 15, 2018, each of which is hereby incorporated by reference in its entirety as though fully set forth herein.

[0045] The stent placement comparison 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.

[0046] The present disclosure aids substantially in the real-time planning of stent placement during an interventional intravascular procedure, by automatically displaying two different stenting options on the same screen, thus allowing a clinician to clearly see the benefits and / or drawbacks of different stent sizes and / or landing zone locations. The system may also automatically determine the proximal and distal landing zones for the virtual stent. Implemented on an IVI console in communication with an IVI catheter or IVI guidewire in communication with a processor such as a patient interface module (PIM), the stent placement comparison 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 determined.

[0047] The stent placement comparison 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. In that regard, the control process performs certain specific operations in response to different inputs or selections made at different times. Certain outputs of the stent placement comparison system may be printed, shown on a display, or otherwise communicated to human operators. Certain structures, functions, and operations of the processor, display, sensors, and user input systems are known in the art, while others are recited herein to enable novel features or aspects of the present disclosure with particularity.

[0048] These descriptions are provided for exemplary purposes only, and should not be considered to limit the scope of the stent placement comparison system. Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter.Docket No. 2024PF00151

[0049] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to the aspects illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and / or steps described with respect to one aspect may be combined with the features, components, and / or steps described with respect to other aspects of the present disclosure. For the sake of brevity, however, the numerous iterations of these combinations will not be described separately.

[0050] Figure 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. For example, the intraluminal device 102 can be a catheter, guide wire, guide catheter, pressure wire, and / or flow wire in various aspects. In some circumstances, the system 100 may include additional elements and / or may be implemented without one or more of the elements illustrated in Figure 1. For example, the system 100 may omit the external imaging system 132.

[0051] The intraluminal imaging system 100 (or intravascular imaging system) can be any type of imaging system suitable for use in the lumens or vasculature of a patient. In some aspects, the intraluminal imaging system 100 is an intravascular ultrasound (IVUS) imaging system. In other aspects, 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.Docket No. 2024PF00151

[0052] It is understood that the system 100 and / or device 102 can be configured to obtain any suitable intraluminal imaging data. In some aspects, the device 102 may include an imaging component of any suitable imaging modality, such as optical imaging, optical coherence tomography (OCT), etc. In some aspects, the device 102 may include any suitable imaging or 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. Generally, 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.

[0053] 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. Optionally, 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. In some aspects, 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.

[0054] 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 SynchronousDocket No. 2024PF00151Optical Networking (SONET). In some cases, 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. For example, the processing system 106 may communicate with a Digital Imaging and Communications in Medicine (DICOM) system, a Picture Archiving and Communication System (PACS), and / or a Hospital Information System (HIS) via a network connection.

[0055] At a high level, 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. For example, the scanner assembly 110 can be a one-dimensional array or a two-dimensional array in some instances. In some instances, the scanner assembly 110 can be a rotational ultrasound device. The active area of the scanner assembly 110 can include one or more transducer materials and / or one or more segments of ultrasound elements (e.g., one or more rows, one or more columns, and / or one or more orientations) that can be uniformly or independently controlled and activated. The active area of the scanner assembly 110 can be patterned or structured in various basic or complex geometries. The scanner assembly 110 can be disposed in a side-looking orientation (e.g., ultrasonic energy emitted perpendicular and / or orthogonal to the longitudinal axis of the intraluminal device 102) and / or a forward-looking looking orientation (e.g., ultrasonic energy emitted parallel to and / or along the longitudinal axis). In some instances, the scanner assembly 110 is structurally arranged to emit and / or receive ultrasonic energy at an oblique angle relative to the longitudinal axis, in a proximal or distal direction. In some aspects, ultrasonic energy emission can be electronically steered by selective triggering of one or more transducer elements of the scanner assembly 110.

[0056] The ultrasound transducer(s) of the scanner assembly 110 can be a piezoelectric micromachined ultrasound transducer (PMUT), capacitive micromachined ultrasonic transducer (CMUT), single crystal, lead zirconate titanate (PZT), PZT composite, other suitable transducerDocket No. 2024PF00151 type, and / or combinations thereof. In an aspect the ultrasound transducer array 124 can include any suitable number of individual transducer elements or acoustic elements between 1 acoustic element and 1000 acoustic elements, including values such as 2 acoustic elements, 4 acoustic elements, 36 acoustic elements, 64 acoustic elements, 128 acoustic elements, 500 acoustic elements, 812 acoustic elements, and / or other values both larger and smaller.

[0057] The PIM 104 transfers the received echo signals to the processing system 106 where the ultrasound image (including the flow information) is reconstructed and displayed on the monitor 108. The console or processing system 106 can include a processor and a memory. The processing system 106 may be operable to facilitate the features of the intraluminal imaging system 100 described herein. For example, the processor can execute computer readable instructions stored on the non-transitory tangible computer readable medium.

[0058] The PIM 104 facilitates communication of signals between the processing system 106 and the scanner assembly 110 included in the intraluminal device 102. This communication may include providing commands to integrated circuit controller chip(s) within the intraluminal device 102, selecting particular element(s) on the transducer array 124 to be used for transmit and receive, providing the transmit trigger signals to the integrated circuit controller chip(s) to activate the transmitter circuitry to generate an electrical pulse to excite the selected transducer array element(s), and / or accepting amplified echo signals received from the selected transducer array element(s) via amplifiers included on the integrated circuit controller chip(s). In some aspects, the PIM 104 performs preliminary processing of the echo data prior to relaying the data to the processing system 106. In examples of such aspects, the PIM 104 performs amplification, filtering, and / or aggregating of the data. In an aspect, the PIM 104 also supplies high- and low- voltage DC power to support operation of the intraluminal device 102 including circuitry within the scanner assembly 110.

[0059] The processing system 106 receives echo data from the scanner assembly 110 by way of the PIM 104 and processes the data to reconstruct an image of the tissue structures in the medium surrounding the scanner assembly 110. Generally, the device 102 can be utilized within any suitable anatomy and / or body lumen of the patient. The processing system 106 outputs image data such that an image of the vessel or lumen 120, such as a cross-sectional IVUS image of the lumen 120, is displayed on the monitor 108. Lumen 120 may represent fluid filled or fluid-surrounded structures, both natural and man-made. Lumen 120 may be within a body of aDocket No. 2024PF00151 patient. Lumen 120 may be a blood vessel, such as an artery or a vein of a patient’s vascular system, including cardiac vasculature, peripheral vasculature, neural vasculature, renal vasculature, and / or or any other suitable lumen inside the body. For example, the device 102 may be used to examine any number of anatomical locations and tissue types, including without limitation, organs including the liver, heart, kidneys, gall bladder, pancreas, lungs; ducts; intestines; nervous system structures including the brain, dural sac, spinal cord and peripheral nerves; the urinary tract; as well as valves within the blood, chambers or other parts of the heart, and / or other systems of the body. In addition to natural structures, the device 102 may be used to examine man-made structures such as, but without limitation, heart valves, stents, shunts, filters and other devices.

[0060] The controller or processing system 106 may include a processing circuit having one or more processors in communication with memory and / or other suitable tangible computer readable storage media. The controller or processing system 106 may be configured to carry out one or more aspects of the present disclosure. In some aspects, the processing system 106 and the monitor 108 are separate components. In other aspects, the processing system 106 and the monitor 108 are integrated in a single component. For example, the system 100 can include a touch screen device, including a housing having a touch screen display and a processor. The system 100 can include any suitable input device, such as a touch sensitive pad or touch screen display, keyboard / mouse, joystick, button, etc., for a user to select options shown on the monitor 108. The processing system 106, the monitor 108, the input device, and / or combinations thereof can be referenced as a controller of the system 100. The controller can be in communication with the device 102, the PIM 104, the processing system 106, the monitor 108, the input device, and / or other components of the system 100.

[0061] In some aspects, the intraluminal device 102 includes some features similar to traditional solid-state IVUS catheters, such those disclosed in U.S. Patent No. 7,846,101, hereby incorporated by reference in its entirety. For example, the intraluminal device 102 may include the scanner assembly 110 near a distal end of the intraluminal device 102 and a transmission line bundle 112 extending along the longitudinal body of the intraluminal device 102. The cable or transmission line bundle 112 can include a plurality of conductors, including one, two, three, four, five, six, seven, or more conductors.Docket No. 2024PF00151

[0062] The transmission line bundle 112 terminates in a PIM connector 114 at a proximal end of the intraluminal device 102. The PIM connector 114 electrically couples the transmission line bundle 112 to the PIM 104 and physically couples the intraluminal device 102 to the PIM 104. In an aspect, the intraluminal device 102 further includes a guidewire exit port 116. Accordingly, in some instances the intraluminal device 102 is a rapid-exchange catheter. The guidewire exit port 116 allows a guidewire 118 to be inserted towards the distal end in order to direct the intraluminal device 102 through the lumen 120.

[0063] The monitor 108 may be a display device such as a computer monitor or other type of screen. The monitor 108 may be used to display selectable prompts, instructions, and visualizations of imaging data to a user. In some aspects, the monitor 108 may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure. This workflow may include performing a pre-stent plan to determine the state of a lumen and potential for a stent, as well as a post-stent inspection to determine the status of a stent that has been positioned in a lumen.

[0064] The external imaging system 132 can be configured to obtain x-ray, radiographic, angiographic / venographic (e.g., with contrast), and / or fluoroscopic (e.g., without contrast) images of the body of a patient (including the vessel 120). External imaging system 132 may also be configured to obtain computed tomography images of the body of the patient (including the vessel 120). The external imaging system 132 may include an external ultrasound probe configured to obtain ultrasound images of the body of the patient (including the vessel 120) while positioned outside the body. In some aspects, the system 100 includes other imaging modality systems (e.g., MRI) to obtain images of the body of the patient (including the vessel 120). The processing system 106 can utilize the images of the body of the patient in conjunction with the intraluminal images obtained by the intraluminal device 102.

[0065] Figure 2 is a schematic diagram of a processor circuit 250, according to aspects of the present disclosure. The processor circuit 250 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. As shown, the processor circuit 250 may include a processor 260, a memory 264, and a communication module 268. These elements may be in direct or indirect communication with each other, for example via one or more buses.Docket No. 2024PF00151

[0066] The processor 260 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 260 may also comprise another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 260 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.

[0067] The memory 264 may include a cache memory (e.g., a cache memory of the processor 260), 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. In an aspect, the memory 264 includes a non-transitory computer-readable medium. The memory 264 may store instructions 266. The instructions 266 may include instructions that, when executed by the processor 260, cause the processor 260 to perform the operations described herein. Instructions 266 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). For example, 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.

[0068] The communication module 268 can include any electronic circuitry and / or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 250, and other processors or devices. In that regard, the communication module 268 can be an input / output (I / O) device. In some instances, the communication module 268 facilitates direct or indirect communication between various elements of the processor circuit 250 and / or the intraluminal imaging system 100. The communication module 268 may communicate within the processor circuit 250 through numerous methods or protocols. Serial communication protocolsDocket No. 2024PF00151 may include but are not limited to United States Serial Protocol Interface (US SPI), Inter- Integrated Circuit (I2C), 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 (US ART), or other appropriate subsystem.

[0069] External communication (including but not limited to software updates, firmware updates, preset sharing between the processor and central server, or readings from the annular ultrasound imaging array) 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. For example, 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. 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.

[0070] It will also be understood that 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. For example, 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. In some aspects, generating the ultrasound images may include beamforming incoming signals from the ultrasound imaging device and processing the beamformed signals by an image processor. TheDocket No. 2024PF00151 processing components of the system can be integrated within the ultrasound imaging device, contained within an external console, or may be a separate component.

[0071] Figure 3A illustrates a blood vessel 300 incorporating a plaque 330, according to aspects of the present disclosure. The plaque 330 occurs within the vessel walls 310 and may restrict the flow of blood 320 by reducing the area of the vessel lumen 315. The lumen 315 is defined by the lumen border, and the vessel well 310 is defined by the lumen border 360 and the vessel border 370.

[0072] In the example shown in Figure 3, the blood vessel includes relatively healthy segments 340 and a diseased segment 350. A distal reference frame or landing zone 344 is located in the healthy region 340 distal of the plaque 330, and has a lumen diameter 316 and a vessel diameter 372. A proximal reference frame or landing zone 346 is located in the healthy region 340 proximal of the plaque 330, and has a lumen diameter 318 and a vessel diameter 376. In between the proximal reference frame 346 and the distal reference frame 344 is a target frame 380, which may for example be the frame at which the minimum lumen area (MLA) occurs. The target frame 380 has a lumen diameter 317 and a vessel diameter 374.

[0073] At any given location along the vessel 300, the lumen has a cross-sectional area associated with the lumen diameter, and the vessel has a cross-sectional area associated with the vessel diameter. Each frame or location also has a plaque burden defined as:(Vessel Area - Lumen Area) / Vessel Area (EQN. 1)

[0074] In some cases, the definition of a diseased segment of a vessel may be any segment of the vessel in which the plaque burden exceeds 50% along the entire length of the segment. Thus, generally speaking, for a diseased vessel, the target frame will have a plaque burden of greater than 50% (and often greater than 70%), whereas the proximal and distal reference frames are selected (e.g., by an automated system) such that they have a plaque burden less than 50%, and may for example be the closest proximal and distal frames to the MLA that meet this criterion.

[0075] In the simplified vessel shown Figure 3, the vessel diameter 372, 374, 376 is the same along the length of the blood vessel. However, it is understood that the vessel diameter can vary along the length of the blood vessel. There can be a different vessel diameter 372 at the distalDocket No. 2024PF00151 reference / landing zone 344, diameter 374 at the target frame 380, and diameter 376 at the proximal reference / landing zone 346.

[0076] Figure 3B illustrates a blood vessel 300 incorporating a plaque 330 and with a stent 440 expanded inside it to restore flow, according to aspects of the present disclosure. The stent 440 displaces and arrests the plaque 330 by pushing the lumen border 360 and vessel border 370 outward, thus reducing the restriction of the blood flow 320. Other treatment options for alleviating a plaque or other occlusion may include but are not limited to thrombectomy, ablation, angioplasty, and pharmaceuticals.

[0077] The stent 440 has a diameter 415. The stent also has a proximal edge 446 that has been placed to coincide with the proximal landing zone 346, and a distal edge 444 that has been placed to coincide with the distal landing zone 344. Along the length of the stent 440, the vessel 300 conforms to the stent such that the lumen diameter is equal to the stent diameter 415 at the proximal landing zone 346, the target frame 380, and the distal reference frame 344, as well as at locations in between these points. Notably, 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. In some cases, the stent may be tapered, such that its diameter 476 at the proximal landing zone 346 may be larger than its diameter 472 at the distal landing zone 344.

[0078] Figure 4A illustrates a blood vessel 300 incorporating a plaque 330, according to aspects of the present disclosure. Visible are the vessel wall 310, vessel lumen 315, blood flow 320, plaque 330, lumen border 360, and target frame or target location 380. In the example shown in Figure 4A, a lesion segment 410, which is the length of vessel where an occlusion value (e.g., plaque burden, percent stenosis, which are different from one another, such as calculated differently) is greater than a threshold value, indicating disease. For example, the lesion segment may consist of locations along the vessel where the plaque burden is greater than 50% (e.g., an example threshold value). The length of the lesion segment is typically a decimal value, e.g., a non-integer, non-whole number value.

[0079] The lesion segment 410 is defined by a distal end 404 and a proximal end 406, which may for example be locations along the vessel 300 at or between locations with occlusions values less than the threshold value and values greater than threshold value. For example, theDocket No. 2024PF00151 distal end 404 and proximal end 406 of the lesion segment 410 may be locations at or between locations with plaque burden greater than 50% and less than 50% (e.g., locations where plaque burden transitions from 50% to 49%. )

[0080] The distal landing zone 420 represents healthy tissue, and can fall at or distal of the distal end 404 of the lesion segment 410. Similarly, the proximal landing zone 430 represents healthy tissue, and can fall at or proximal of the proximal end 406 of the lesion segment 410. The distal landing zone 420 and proximal landing zone 430 may be locations different or distinct from the lesion segment 410, e.g., healthy locations spaced from the proximal and distal ends of the lesion segment 410, and may each represent a potential location or locations (e.g., a region) where the proximal and distal stent edges can be positioned when a stent is deployed.

[0081] The target frame or target location 380 is a location along the vessel 300 that has the maximum occlusion value, and falls between the distal end 404 and proximal end 406 of the lesion segment 410.

[0082] A virtual stent 400 is movable along the length of the vessel 300, and includes a distal end 414 which falls within the range of distal landing zones 420, and a proximal end 416 which falls within the range of proximal landing zones 430. The virtual stent 400 can be different or distinct from the lesion segment 410, and represents the planned length of the stent (e.g., at least as long as, or longer than, the lesion segment), and the planned location of the stent along the vessel 300. As described herein, the planned length of vessel can be an integer or whole number value, because real stents (e.g., commercially available stents) are typically in integer or whole number lengths (e.g., 5 mm, 6 mm, etc.).

[0083] Figure 4B illustrates a blood vessel 300 incorporating a plaque 330 and with a stent 440 expanded inside it to restore flow, according to aspects of the present disclosure. Visible are the blood flow 320, lumen border 360, and target frame or target location 380. In the example shown in Figure 4B, a stent 440 has been placed such that its distal end 444 is within the range of distal landing zones 420 (e.g., at or distal of the distal end 404 of the lesion segment 410), and its proximal end 446 is within the range of proximal landing zones 430 (e.g., at or proximal of the proximal end 406 of the lesion segment 410).

[0084] The length of the stent 440 can be different or distinct from the length of the lesion segment 410. The length of the stent 440 extends over the entire lesion segment 410 (e.g., expanding the diameter of the lesion segment 410, to increase or restore blood flow 320 throughDocket No. 2024PF00151 the length of the vessel 300 with the lesion segment 410). The length of the stent (at least as long as or longer than lesion segment) can be an integer or whole number value, because real stents (e.g., commercially available stents) are typically in integer or whole number lengths. The distal end 444 of the stent 440 can be different from the distal end 404 of the lesion segment 410 (e.g., spaced from the distal end 404 of the lesion segment 410), with a location somewhere within the range of distal landing zones 420. The proximal end 446 of the stent 440 can be different from the proximal end 406 of the lesion segment 410 (e.g., spaced from the proximal end of the lesion segment), with a location somewhere within the range of proximal landing zones 430.

[0085] Figure 5 is a screen display 500 of an example stent placement comparison system, according to aspects of the present disclosure. The screen display 500 may for example be generated by an IVI (e.g., IVUS or OCT) image analysis system configured for stent planning. The screen display 500 for comparison of commercially available stent lengths includes a first treatment plan area 510 (“Treatment Plan A”) and a second treatment plan area 560 ("Treatment Plan B”).

[0086] In the example shown in Figure 5, the first treatment plan area 510 includes a stent length input area 512 that includes available stent length options 514 (e.g., a list, pull-down menu, + / - buttons, etc.) and a first selected stent length 516. The first treatment plan area 510 also includes a longitudinal view area 530, which includes an image-based longitudinal display (ILD) or graphical longitudinal view 532 of the vessel to be treated, overlaid with a visual representation 534 of the first selected available stent length 516. The first treatment plan area 510 also includes an extravascular image area 540, which includes an extravascular image 542 (e.g., an x-ray image with contrast, showing the blood vessel to be treated), overlaid with a visual representation 544 of the first selected available stent length 516. The first treatment plan area 510 also includes an intravascular images area 550, which includes an intravascular image 552 and associated metrics 554 at the distal edge of the first selected stent, along with an intravascular image 556 and associated metrics 558 at the proximal edge of the first selected stent. In some aspects, the intravascular images area 550 may also include other images, such as a target frame and associated metrics captured at the location of the minimum lumen area.

[0087] In the example shown in Figure 5, the second treatment plan area 560 includes a stent length input area or input field 562 that includes available stent length options 564 and a secondDocket No. 2024PF00151 selected stent length 566. The second treatment plan area 560 also includes a longitudinal view area 570, which includes an image-based longitudinal display (ILD) or graphical longitudinal view 572 of the vessel to be treated, overlaid with a visual representation 574 of the second selected available stent length 566. The second treatment plan area 560 also includes an extravascular image area 580, which includes an extravascular image 582 (e.g., an x-ray image with contrast, showing the blood vessel to be treated), overlaid with a visual representation 584 of the second selected available stent length 566. The second treatment plan area 560 also includes an intravascular images area 590, which includes an intravascular image 592 and associated metrics 594 at the distal edge of the second selected stent, along with an intravascular image 596 and associated metrics 598 at the proximal edge of the second selected stent. In some aspects, the intravascular images area 590 may also include other images, such as a target frame and associated metrics captured at the location of the minimum lumen area.

[0088] By showing images and information associated with a first selected stent length 516 simultaneously, on the same display, with images and information associated with the second selected stent length 566, the screen display 500 enables the user (e.g., a clinician) to compare the possible advantages and possible disadvantages of each stent length, without changing either stent length and without having to switch between screens. In an example, the system may simultaneously show two copies of the same extravascular image, two copies of same longitudinal view, intravascular images for first stent length, and intravascular images for the second stent length. This streamlined analysis process reduces the time and effort required to select a desired stent length to meet various selection criteria, as described below.

[0089] Generating a longitudinal view of the vessel is described for example in U.S. Publication No. 2023 / 0181140, filed December 6, 2022, U.S. Provisional Application No. 63 / 288,553, filed December 11, 2021, U.S. Provisional Application No. 63 / 292,529 filed December 22, 2021, International Publication No. WO 2023 / 104541, filed December 7, 2022, International Publication No. WO 2024 / 120659, filed March 28, 2023, and U.S. Application No. 16 / 663,020, filed October 24, 2019, each of which is hereby incorporated by reference as though fully set forth herein.

[0090] Figure 6 is a screen display 600 of an example stent placement comparison system, according to aspects of the present disclosure. In an example illustrated by Figure 6, a user (e.g., a physician or other clinician) is not sure whether to place a 12 mm stent or a 16 mm stent intoDocket No. 2024PF00151 the vessel 300. Typically, a physician wants to minimize the amount of stent (e.g., the amount of metal or other foreign material) inside the vessel (which weighs in favor of physician choosing the 12 mm stent). However, the physician may add a longer stent (e.g., more metal or other foreign material) (e.g., the 16 mm stent) if physiological benefit to the patient (e.g., decrease in plaque burden, indicative of expected restoration of more blood flow) is large enough to justify the added length.

[0091] The stent placement comparison system therefore outputs a screen display 600 with a comparison view, which simultaneously shows both treatment options (e.g., 12 mm and 16 mm). For each treatment option, the screen display 600 includes the extravascular image 542, 582 (with a graphical representation 544, 548 of the corresponding stent length overlaid on the vessel 300) and intravascular images and corresponding metrics for the proximal and distal ends of the stent. The metrics can include the plaque burden at the proximal and distal ends of stent.

[0092] Based on this, physician determine, whether the plaque burden at proximal and distal ends of 16 mm stent actually provide enough benefit over the 12 mm stent to justify using the 16 mm stent. In the example shown in Figure 6, the benefit is only a 1.3% improvement in plaque burden, so the physician may decide not to add the extra 4 mm of stent length, especially because plaque burdens for both 12 mm and 16 mm are below 50%, which may for example be an exemplary threshold defining which vascular tissue is diseased and which is healthy.

[0093] Visible in the screen display 600 is an Option A area 510, containing a selected stent length 512, extravascular image 542, and visual representation 544 of the first selected stent length 512 (e.g., a first virtual stent). The Option A area 510 also includes an intravascular image display area 550, which includes a radial cross-sectional or tomographic image 552 and associated vessel / lumen metrics 554 captured at the distal end of the virtual stent, and a radial cross-sectional or tomographic image 556 and associated vessel / lumen metrics 558 captured at the proximal end of the first virtual stent.

[0094] Also visible in the screen display 600 is an Option B area 560, containing a selected stent length 562, extravascular image 582, and visual representation 584 of the second selected stent length 562 (e.g., a second virtual stent). The Option B area 560 also includes an intravascular image display area 590, which includes a radial cross-sectional or tomographic image 592 and associated vessel / lumen metrics 594 captured at the distal end of the virtual stent,Docket No. 2024PF00151 and a radial cross-sectional or tomographic image 596 and associated vessel / lumen metrics 598 captured at the proximal end of the second virtual stent.

[0095] Figure 6 is an example of a comparison view screen display for planning a stent (e.g., to provide treatment for the lesion), where the display includes a first stent option area and a second stent option area that are, advantageously, displayed simultaneously on a single screen. In some aspects, there may be additional stent option areas (e.g., three, four, or more stent option areas) for describing a third stent length, a third stent location (e.g. a third distal and proximal landing zone), etc. In some aspects, the processor circuit may be configured to transition to the comparison view screen display (e.g., Figure 6) from another screen display (e.g., Figure 18, 19, 20, 21, 22, 23, or 24) that does not display the first stent option area and the second stent option area simultaneously on the single screen.

[0096] Figure 7 is a schematic, diagrammatic representation, in flow diagram form, of an example stent placement comparison method 700, according to aspects of the present disclosure. It is understood that the steps of method 700 may be performed in a different order than shown in Figure 7, additional steps can be provided before, during, and after the steps, and / or some of the steps described can be replaced or eliminated in other aspects. One or more of steps of the method 700 can be carried by one or more devices and / or systems described herein, such as components of the intravascular imaging system 100 and / or processor circuit 250.

[0097] In step 710, the method 700 includes controlling the intravascular imaging catheter to obtain intravascular image data (e.g., radial / tomographic image frames) during movement (e.g., pullback) through the blood vessel. Execution then proceeds to step 710.

[0098] In step 720, the method 700 includes automatically identifying the vessel and / or lumen borders in the radial / tomographic image frames. Execution then proceeds to step 730.

[0099] In step 730, the method 700 includes determining, based on the identified vessel border and / or lumen border, vessel and / or lumen metric(s) for the blood vessel, possibly including but not limited to vessel diameter(s), vessel cross-sectional area, lumen diameter(s), lumen cross-sectional area, plaque burden, etc. Execution then proceeds, to step 780 and, in parallel, to at least one of steps 740, 750, 760, and 770, depending on the implementation and / or user inputs.

[0100] In step 740, the method 700 includes obtaining the first stent length, from a list of available stent lengths. The first available stent length may be selected automatically (based onDocket No. 2024PF00151 vessel metric(s) and / or lumen metric(s), and / or other metrics calculated therefrom, such as plaque burden) or based on a user input. Execution then proceeds to 790, and optionally, in parallel, to step 750.

[0101] In step 750, the method 700 includes obtaining the location (e.g., proximal and distal landing zones) for the first obtained stent length. The location may be obtained automatically (based on vessel metric(s) and / or lumen metric(s), and / or other metrics calculated therefrom, such as plaque burden) or based on a user input. Execution then proceeds to step 790.

[0102] In step 760, the method 700 includes obtaining the second stent length, from a list of available stent lengths. The second available stent length may be selected automatically(based on vessel metric(s) and / or lumen metric(s), and / or other metrics calculated therefrom, such as plaque burden) or based on a user input. Execution then proceeds to step 790 and, optionally, in parallel, to step 770.

[0103] In step 770, the method 700 includes obtaining the location for second obtained stent length. The location may be obtained automatically (based on vessel metric(s) and / or lumen metric(s), and / or other metrics calculated therefrom, such as plaque burden) or based on a user input. Execution then proceeds to step 790.

[0104] In step 780, the method 700 includes performing co-registration between the intravascular image frames and the extravascular image (e.g., x-ray image with contrast). Execution then proceeds to step 790.

[0105] In step 790, the method 700 includes outputting, to a display, a screen display for a comparison view of the two obtained stent lengths. The method 700 is now complete.

[0106] Flow diagrams are provided herein for exemplary purposes; a person of ordinary skill in the art will recognize myriad variations that nonetheless fall within the scope of the present disclosure. For example, any of the steps described herein may optionally include an output to a user of information relevant to the step, and may thus represent an improvement in the user interface over existing art by providing information not otherwise available.

[0107] Similarly, 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. In order to perform the methods described herein, 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 severalDocket No. 2024PF00151 hundred, several thousand, several million, or several billion per second, in a single processor or across a plurality of processors. Such rapid execution may be necessary in order to execute the method in real time or near-real time as described herein. For example, in response to user inputs, the system may generate, move, and / or resize, in real time, co-registered representations of one or more virtual stents on multiple images, including but not limited to x-ray images, ILD images, and intravascular images.

[0108] Figure 8 is a schematic, diagrammatic representation, in block diagram form, of an example stent placement comparison system, according to aspects of the present disclosure.

[0109] In the example shown in Figure 8, a stent length 810 is selected from a list of commercially available stent lengths. This may be selected based on a user input 830, or may be an automatic determination 820 (as described for example in U.S. Provisional App. No. , filed , and titled “Intravascular-Imaging Based Automatic Stent Length Determination And Landing Zone Selection” (Atty Dkt. No. 2023PF00152 / 44755.2422PV01)), which is incorporated by reference herein in its entirety. The automatic determination 820 can be based on a non-integer / non-whole number length between the identified ends of the lesion segment (e.g., proximal and distal locations where the plaque burden is less than 50%), rounded up to the next largest available stent size (whole number / integer length) from the list of available stent sizes.

[0110] A location 840 for the selected, commercially available stent size 810 is then determined. This determination may for example be based on a user input (e.g., clicking and dragging a virtual stent on the x-ray roadmap image). Alternatively, the location (e.g., proximal and distal landing zones) may be an automatic determination 850 (as described for example in U.S. Provisional App. No. , filed , and titled “Intravascular-Imaging Based Automatic Stent Length Determination And Landing Zone Selection” (Atty Dkt. No. 2023PF00152 / 44755.2422PV01)), which is incorporated by reference herein in its entirety. The automatic determination 850 can be based on identifying the landing zones for the identified stent length that, e.g., maximize the total amount of plaque covered by the stent, while keeping the plaque burden at each end to less than 50%, and / or other criteria.

[0111] The stent length 810 and location 840 are determined for the first comparison stent and displayed on a comparison screen display 870 as treatment plan A, 880. The stent lengthDocket No. 2024PF00151810 and location 840 are then determined for the second comparison stent and displayed on the comparison screen display 870 as treatment plan B, 890.

[0112] Block diagrams are provided herein for exemplary purposes; a person of ordinary skill in the art will recognize myriad variations that nonetheless fall within the scope of the present disclosure. For example, any of the steps described herein may optionally include an output to a user of information relevant to the step, and may thus represent an improvement in the user interface over existing art by providing information not otherwise available.

[0113] Similarly, block diagrams may show a particular arrangement of components, modules, services, steps, processes, or layers, resulting in a particular data flow. It is understood that some embodiments of the systems disclosed herein may include additional components, that some components shown may be absent from some embodiments, and that the arrangement of components may be different than shown, resulting in different data flows while still performing the methods described herein.

[0114] Figure 9 is a screen display 900 of an example stent placement comparison system, according to aspects of the present disclosure. Visible are the Option A area 510, containing a selected stent length 512, extravascular image 542, first virtual stent 544, intravascular image display area 550, distal tomographic image 552 and associated first vessel / lumen metrics 554, and proximal tomographic image 556 and associated first vessel / lumen metrics. Also visible is the Option B area 560, containing a selected stent length 562, extravascular image 582, second virtual stent 584, intravascular image display area 590, distal tomographic image 592 and associated second vessel / lumen metrics 594, and proximal tomographic image 596 and associated second vessel / lumen metrics 598.

[0115] The screen display 900 of Figure 9 is similar to the screen display 600 of Figure 6. However, in the example shown in Figure 9, the user has used a pointer 920 (e.g., a mouse pointer or touchscreen) to activate a pull-down menu 910 to change the length of the second virtual stent 584 from 16 mm to a new selection 930 of 10 mm. This may be done for example because the clinician determines that the extra 4 mm of length on the 16 mm stent does not provide a significant benefit. Therefore, the clinician may wish to see whether the benefits of a 12 mm stent, or most of the benefits, may be available with a stent shorter than 12 mm.

[0116] Figure 10 is a schematic, diagrammatic representation, in block diagram form, of an example determination 1000 of available stent lengths to show the user (e.g., in list or drop-downDocket No. 2024PF00151 menu 1030, which may be the drop-down menu 910 of Figure 9), according to aspects of the present disclosure. A manufacturer-maintained list 1010 includes all known, commonly available commercial stent sizes. However, this list 1010 can be overridden by a user- maintained list 1020 that includes only those commercially available stent sizes that are actually present in the inventory of the catheterization laboratory. Thus, the user-maintained list 1020 may be a subset of the manufacturer-maintained list 1010, although in some cases it may, instead or in addition, include custom stent sizes not available in the manufacturer-maintained list 1020. The preferred list (e.g., list 1010 if not overridden by list 1020, or list 1020 if available) is then presented to the user as the available stent options 1030. This may be in the form of a list or pull-down menu, or may be hidden from the user but implemented as the output of a set of + / - buttons, where a “+” button selects the next larger size on the list 1030, and a button selects the next smaller size on the list 1030.

[0117] Figure 11 is a screen display 1100 of an example stent placement comparison system, according to aspects of the present disclosure. Visible are the Option A area 510, containing a selected stent length 512, extravascular image 542, first virtual stent 544, intravascular image display area 550, distal tomographic image 552 and associated vessel / lumen metrics 554, and proximal tomographic image 556 and associated vessel / lumen metrics. Also visible is the Option B area 560, containing a selected stent length 562, extravascular image 582, second virtual stent 584, intravascular image display area 590, distal tomographic image 592 and associated vessel / lumen metrics 594, and proximal tomographic image 596 and associated vessel / lumen metrics 598.

[0118] The screen display 1100 of Figure 11 is similar to the screen display 600 of Figure 6. However, in the example shown in Figure 11, the user has replaced the 16mm stent length 562 with a 10 mm stent length 562. This has moved the distal tomographic image frame 592 in a more proximal direction by 43 frames, resulting in a distal plaque burden of 55.7%. Since this is above the 50% plaque burden threshold often used to distinguish between healthy and diseased vascular tissue, this may not be an acceptable landing zone for the stent. The clinician, seeing this result, may therefore wish to move the stent to a more favorable location and / or increase the size of the stent. Figure 11 shows the utility of the stent placement comparison system, which enables the clinician to see, at a glance, that the 12 mm stent is likely to be preferable over the 10 mm stent.Docket No. 2024PF00151

[0119] Figure 12 is a screen display 1200 of an example stent placement comparison system, according to aspects of the present disclosure. Visible are the Option A area 510, containing a selected stent length 512, extravascular image 542, first virtual stent 544, intravascular image display area 550, distal tomographic image 552 and associated vessel / lumen metrics 554, and proximal tomographic image 556 and associated vessel / lumen metrics. Also visible is the Option B area 560, containing a selected stent length 562, extravascular image 582, second virtual stent 584, intravascular image display area 590, distal tomographic image 592 and associated vessel / lumen metrics 594, and proximal tomographic image 596 and associated vessel / lumen metrics 598.

[0120] The screen display 1200 of Figure 12 is similar to the screen display 600 of Figure 6, except that in the example shown in Figure 13, both virtual stents 544, 584 are of the same size (16 mm) and in the same location (spanning frames 102-232). However, the user has used a pointer 1210 to grab the virtual stent 584 of option B 560, in order to relocate the virtual stent by moving it in a proximal or distal direction without affecting the length of the virtual stent (as described for example in U.S. Provisional App. No. 63 / 550,709, filed February 7, 2024, and titled “Stent Placement Planning With Intravascular Imaging And Associated Systems, Devices, And Methods”). This may be done for example to compare two different locations (e.g., different proximal and distal landing zones) for the same stent size, but it may also be used to relocate stents of different sizes. In an example, the clinician may wish to manually find the best overall location for a 12 mm stent, and then compare it to the best overall location for a 16 mm stent, to see which one has the most favorable overall clinical profile.

[0121] Reasons for relocating a virtual stent include, but are not limited to: (1) Making both landing zones have equal plaque burden. For example, for a 38mm stent, it may be desirable to find the two IVUS frames that are 38mm apart, proximal and distal to the lesion, that have equal plaque burden (e.g., within a threshold amount of one another). (2) Making sure both ends of the virtual stent are a sufficient distance from significant disease (e.g., more than 5 frames away from a plaque burden of 50% or greater). For example, it must be at least x mm from the minimum lumen area, x number of mm from a certain plaque burden percentage (e.g., 75%), or x mm from locations in an iFR pullback with multiple dots (representing a significant pressure drop). (3) Maximizing the amount of plaque covered by the stent. (4) Maximizing the average plaque burden percentage covered by the stent. This is different from maximizing the amount ofDocket No. 2024PF00151 plaque because the vessel may not be uniform in diameter but rather tapered along its length. Two locations can have the same plaque burden but different amounts of plaque. (5) Minimizing the combined (e.g., summed) plaque burden at the landing zones. In some cases, by moving the virtual stent more proximal or more distal, it may be possible to significantly reduce the plaque burden at one of the landing zones with a less significant impact to the other landing zone. For example, a 38 mm virtual stent might be able to have landing zones with equal plaque burden, 41% at each landing zone, or that same 38 mm virtual stent might be able to be placed in a slightly different location with 42% plaque burden at one landing zone and 30% plaque burden at the other. (6) Prioritizing additional stent length on the end that is closest to severe disease (e.g., to the location of the minimum lumen area). In some cases, there may be a localized minimum plaque burden on one end. (7) Avoiding landing zones that partially cover side branches of the blood vessel.

[0122] Figure 13 is a screen display 1100 of an example stent placement comparison system, according to aspects of the present disclosure. Visible are the Option A area 510, containing a selected stent length 512, extravascular image 542, first virtual stent 544, intravascular image display area 550, distal tomographic image 552 and associated vessel / lumen metrics 554, and proximal tomographic image 556 and associated vessel / lumen metrics. Also visible is the Option B area 560, containing a selected stent length 562, extravascular image 582, second virtual stent 584, intravascular image display area 590, distal tomographic image 592 and associated vessel / lumen metrics 594, and proximal tomographic image 596 and associated vessel / lumen metrics 598.

[0123] The screen display 1300 of Figure 13 is similar to the screen display 600 of Figure 6. However, in the example shown in Figure 13, the user is now comparing two stents of the same length (16 mm) in two slightly different locations. In the Option A example 510, the vessel / lumen metrics 554, 558 show that the plaque burden is less than 50% for both the proximal and distal landing zones, and also that the two plaque burdens are approximately equal (e.g., within 1.8% of one another). Thus, the landing zones of Option A may be deemed acceptable to the clinician.

[0124] Conversely, in the Option B example 560, the vessel / lumen metrics 594, 598 show that the plaque burdens are highly unequal (e.g., they differ by more than 17%), and also that the distal landing zone has a plaque burden of 55.7%, which is greater than the 50% threshold oftenDocket No. 2024PF00151 used to differentiate healthy from diseased vascular tissue. Thus, the clinician can see, at a glance, that the virtual stent 544 of Option A 510 is in a favorable location, whereas moving it 20 frames proximally results in an unfavorable location for virtual stent 584 of Option B 560. Thus, the stent placement comparison system has provided the clinician with valuable clinical insight that existing systems would not provide.

[0125] Figure 14 is a schematic, diagrammatic representation, in block diagram form, of three different types of user input, according to aspects of the present disclosure. In a first example, the user is viewing a screen display 1410 for intravascular image review and / or a coregistered view of intravascular and extravascular images (as shown for example in Figure 18, below), and selects a user input 1420 to “Add Length” or “Add Segment”, e.g., to add an available stent length from the list of available stent lengths. The user then selects two available stent lengths from the list, and is taken to a screen display 1470 showing a comparison view for the two stent sizes, as shown above for example in Figures 6 and 11-13. In a second example, the user is viewing a screen display 1430 showing two available stent lengths (as shown for example in Figure 16, below), and selects a user input 1440 for “Comparison View” of two available stent lengths. The user is then taken to the screen display 1470 for comparison of the two stent lengths. In a third example, the user is viewing a screen display 1450 for a lesion segment view (ss shown for example in Figure 20, below), and selects a user input 1460 to select two available stent lengths from the list of commercially available stent lengths, and is taken to the screen display 1470 showing the comparison view for the two selected stent lengths. Other user inputs may be used instead in in addition, without departing from the spirit of the present disclosure.

[0126] Figure 15 is a schematic, diagrammatic representation of a co-registered image screen display 1500, according to aspects of the present disclosure. The screen display 1500 may for example be similar to the screen display 1800 of Figure 18, below. The screen display 1500 includes a longitudinal view or ILD 532 showing a current scrubber location 1510, where the scrubber is a user control to select a particular tomographic image or image location from the pullback sequence. The screen display 1500 also includes an extravascular image 542, which also shows the current scrubber location 1510. The screen display 1500 also includes a radial cross-sectional image or tomographic intravascular image 1520 for the current scrubber location, along with associated vessel / lumen metrics 1530 for the tomographic image 1520. ScreenDocket No. 2024PF00151 displays such as the screen display 1500 may be used by a clinician to review an intravascular pullback sequence, identify a lesion segment or diseased segment of the blood vessel, and formulate a treatment plan for stenting the lesion segment to restore blood flow.

[0127] Figure 16 is a screen display 1600 for switching back and forth between two different stent options, according to aspects of the present disclosure. The two stent options may for example be two different stent lengths, selected from a list of commercially available stent lengths. In some aspects, the two stent options may be two different locations for two instances of the same stent length.

[0128] In a first configuration 1602, entered for example via a user input 1606, the user has selected the first of two stent options. The screen display 1600 then includes the extravascular image 542 showing the first stent option 1610 being selected. This may be shown for example through bolding, highlighting, or coloring the first virtual stent 1610. The extravascular image 542 also includes the second stent option 1620 being unselected. This may be shown for example through dotted lines, graying out, or otherwise de-emphasizing the second virtual stent 1620. The screen display 1600 also includes the longitudinal view 532, showing the first stent option 1610 as selected and the second stent option 1620 as unselected. The screen display 1600 also includes a radial cross-sectional or tomographic intravascular image 552 of the distal end of the first virtual stent 1610, a radial cross-sectional or tomographic intravascular image 1630 of the target frame for the first virtual stent 1610, and a radial cross-sectional or tomographic intravascular image 556 of the proximal end of the first virtual stent 1610. The screen display 1600 also includes the vessel / lumen metrics 554, 1640, and 558, associated with the distal, target, and proximal tomographic images, respectively.

[0129] In a second configuration 1604, entered for example via a user input 1608, the user has selected the second of two stent options. The screen display 1600 then includes the extravascular image 542 showing the first stent option 1610 being unselected, and the second stent option 1620 being selected. The screen display 1600 also includes the longitudinal view 532, showing the first stent option 1610 as unselected and the second stent option 1620 as selected. The screen display 1600 also includes a radial cross-sectional or tomographic intravascular image 592 of the distal end of the second virtual stent 1620, a radial cross-sectional or tomographic intravascular image 1650 of the target frame for the second virtual stent 1620, and a radial cross-sectional or tomographic intravascular image 596 of the proximal end of theDocket No. 2024PF00151 second virtual stent 1620. The screen display 1600 also includes the vessel / lumen metrics 594, 1660, and 598, associated with the distal, target, and proximal tomographic images, respectively.

[0130] By switching back and forth between the two configurations 1602 and 1604, the clinician is able to see differences between the vessel / lumen metrics for the two different stent options, and thus determine which option is preferable by the criteria described above.

[0131] Figure 17 is a screen display 1700 for switching back and forth between two different lesions, according to aspects of the present disclosure. The lesions may be in different locations within the vessel and have different lengths and vessel / lumen metrics. Selecting between different lesions in the same blood vessel is different from selecting between two different stent options for treating the same lesion.

[0132] In a first configuration 1702, entered for example via a user input 1706, the user has selected the first of two lesions. The screen display 1700 then includes the extravascular image 1705 showing the first lesion 1710 being selected. This may be shown for example through bolding, highlighting, or coloring the first lesion 1710. The extravascular image 1705 also includes the second lesion 1715 being unselected. This may be shown for example through dotted lines, graying out, or otherwise de-emphasizing the second lesion 1715. The screen display 1700 also includes a longitudinal view 1718, showing the first lesion 1710 as selected and the second stent option 1715 as unselected. The screen display 1700 also includes a radial cross-sectional or tomographic intravascular image 1720 of the distal end of the first lesion 1710, a radial cross-sectional or tomographic intravascular image 1730 of the target frame for the first lesion 1710, and a radial cross-sectional or tomographic intravascular image 1740 of the proximal end of the first lesion 1710. The screen display 1600 also includes the vessel / lumen metrics 1725, 1735, and 1745, associated with the distal, target, and proximal tomographic images, respectively.

[0133] In a second configuration 1704, entered for example via a user input 1708, the user has selected the second of the two lesions. The screen display 1700 then includes the extravascular image 1705 showing the first lesion 1710 being unselected, and the second lesion 1715 being selected. The screen display 1700 also includes the longitudinal view 1718, showing the lesion 1710 as unselected and the second lesion 1715 as selected. The screen display 1700 also includes a radial cross-sectional or tomographic intravascular image 1750 of the distal end of the second lesion 1715, a radial cross-sectional or tomographic intravascular image 1760 ofDocket No. 2024PF00151 the target frame for the second lesion 1715, and a radial cross-sectional or tomographic intravascular image 1770 of the proximal end of the second lesion 1715. The screen display 1700 also includes the vessel / lumen metrics 1755, 1765, and 1775, associated with the distal, target, and proximal tomographic images, respectively.

[0134] By switching back and forth between the two lesions, the clinician is able to assess the length and vessel / lumen metrics for each lesion, as part of formulating a treatment plan. Switching back and forth between two different lesions is different than switching back and forth between two different stent options for the same lesion.

[0135] Figure 18 is a screen display 1800 showing three co-registered views of the blood vessel 300, according to aspects of the present disclosure. The screen display 1800 includes the extravascular image 542 (e.g., an angiogram or x-ray image with contrast) and the longitudinal view or ILD 532, each showing the position of a movable scrubber 1510. The scrubber 1510 is a user control for selecting locations along the blood vessel 300. The screen display 1800 also includes a radial cross-sectional or tomographic intravascular image 1520 captured at the location of the scrubber 1510, along with vessel / lumen metrics 1530 captured at the location of the scrubber. By moving the scrubber 1510, the user can cycle through the different tomographic intravascular images of the pullback sequence to assess a lesion 1710 in the blood vessel 300. Moving the scrubber 1510 in the ILD 532 also moves the scrubber 1510 in the extraluminal image 542, and vice-versa.

[0136] In the example shown in Figure 18, the user has used a pointer 1810 (e.g., a mouse pointer or touchscreen) to activate an “Add Length” button 1820, which has called up a menu 1830 of available stent lengths (e.g., from the user-maintained list of stent lengths locally available in the cath lab).

[0137] Figure 19 is a screen display 1800 showing three co-registered views of the blood vessel 300, according to aspects of the present disclosure. Figure 19 is similar to Figure 18, except that the user has moved the pointer 1810 to select a first desired stent length 1910 from the menu 1830. This selection may be made manually, based on the length of a lesion 1710 indicated by the vessel / lumen metrics 1530. For example, if the indicated lesion is 12.5 millimeters long, then a 12 mm stent may be too small to fully cover the lesion, whereas the next larger size, 15 mm, is large enough to fully cover the lesion. The numbers shown in the menuDocket No. 2024PF001511830 are exemplary, and may differ depending on the inventory of commercially available stents at the cath lab.

[0138] Figure 20 is a screen display 2000 showing exemplary placement of the first selected stent length 2010, according to aspects of the present disclosure. The screen display includes the extraluminal image 542 and the longitudinal display or ILD 532. However, instead of displaying a scrubber, the extraluminal image 542 and ILD 532 now display a virtual stent 2050 covering the lesion 1710. The proximal and distal landing zones may be automatically selected by the stent placement comparison system, as described above.

[0139] The virtual stent 2050 includes a proximal handle 2020 and distal handle 2030, either of which can be grabbed and pulled to resize the virtual stent 2050 to the next larger or smaller available size, by moving the corresponding landing zone. The virtual stent 2050 also includes a target marker 2040 indicating the presence of the minimum lumen area of the lesion 1710.

[0140] The screen display 2000 also includes a distal landing zone tomographic image 552, with corresponding vessel / lumen metrics 554, a target frame tomographic image 1610 with corresponding vessel / lumen metrics 1620, and a proximal landing zone tomographic image 556 with corresponding lumen metrics 558. It is noted that the distal plaque burden 2060 and proximal plaque burden 2070 are within 0.5% of one another, and are both well under the 50% threshold that is often used to differentiate healthy tissue from diseased (lesion) tissue. Thus, a clinician may conclude that the 15 mm stent is suitable for covering the lesion 1710, and may wish to compare it to a shorter stent.

[0141] Figure 21 is a screen display 1800 showing three co-registered views of the blood vessel 300, according to aspects of the present disclosure. Figure 21 is similar to Figure 19, except that the user has used the pointer 1810 to select, from the menu 1830, a second desired stent length 2110 (e.g., 12 mm) in addition to the first desired stent length 1910. This can be done for example to compare the two stent options, as described above. Depending on the implementation, such a comparison screen display, similar to Figure 6, may open automatically or based on a user control.

[0142] Figure 22 is a screen display 2200 showing three co-registered views of the blood vessel 300, according to aspects of the present disclosure. Figure 22 is similar to Figure 21, except that the user has used the pointer 1810 to click a “Compare Stent View” button, in order to bring up a stent comparison screen, as shown for example in Figure 6. The stent comparisonDocket No. 2024PF00151 screen will then compare the results for the first selected stent length 1910 and the second selected stent length 2110.

[0143] Figure 23 is a lesion detail screen display 2300 showing the location and vessel / lumen metrics of a lesion 1710, according to aspects of the present disclosure. The screen display 2300 includes the extraluminal image 542 and the longitudinal display or ILD 532. The extraluminal image 542 and ILD 532 each display a lesion 1710. The proximal and distal ends of the lesion may be automatically determined by the stent placement comparison system, as described above.

[0144] The lesion 1710 includes a proximal handle 2020 and distal handle 2030, either of which can be grabbed and pulled to resize a virtual stent 2050 to the next larger or smaller available size, by moving the corresponding landing zone. The lesion 1710 also includes a target marker 2040 indicating the location of the minimum lumen area of the lesion 1710.

[0145] The screen display 2300 also includes a distal lesion end tomographic image 552, with corresponding vessel / lumen metrics 554, a target frame tomographic image 1610 with corresponding vessel / lumen metrics 1620, and a proximal lesion end tomographic image 556 with corresponding lumen metrics 558. It is noted that the lesion length 2310 (in this example, 10.9 mm) is a non-integer / non-whole number value that may not match the dimensions of any commercially available stent. Therefore, the user has used the pointer 1810 to click on a “Compare Stent Options” button, in order to bring up a stent comparison screen. The stent comparison screen may for example bring up the next two stent sizes that are larger than the lesion length 2310. The stent comparison screen may resemble either or both of Figure 9 or Figure 24, or may have a different configuration that is nevertheless in keeping with the spirit of the present disclosure.

[0146] Figure 24 is an example stent option comparison screen 2400, according to aspects of the present disclosure. Figure 24 is similar to Figure 20, except that in addition to the first selected stent length 2010, a second stent length 2410 has also been selected. In an example, these stent lengths and their associated landing zones are selected automatically by the stent placement comparison system, but are user editable by clicking on the stent length 2010 or 2410 and either typing in a new value or selecting one from a menu. In the example shown in Figure 24, the first stent size 2010 (option “A”) is selected, and the second stent size 2410 (option “B”) is unselected, such that the distal, target, and proximal tomographic images 552, 1610, and 556,Docket No. 2024PF00151 and their associated vessel / lumen metrics 554, 1620, and 558, are representative of the landing zones of the first virtual stent 2050.

[0147] However, the extravascular image 542 and the longitudinal display or ILD 532 each show both the first virtual stent 2050 (here represented in dark black) and the second virtual stent 2450 (here represented in fine white, dotted lines) at the same time, such that either stent can be selected (e.g. clicked on). The selected virtual stent can also be resized by, e.g., typing a new value 2010 or 2410, by using a pull-down menu (as shown for example in Figure 21), or by clicking and dragging one or both of the virtual stent’s handles 2020, 2030.

[0148] Other screen displays may be used instead or in addition, to compare the results (e.g., vessel / lumen metrics) of two different stent sizes and / or two different stent locations, without departing from the spirit of the present disclosure. Depending on the implementation, when length is automatically added to a stent (e.g., when rounding up to the next available size), both landing zones may be recalculated automatically, or length may be added only to the distal landing zone, only to the proximal landing zone, or to both landing zones equally.

[0149] Accordingly, it can be seen that the stent placement comparison system advantageously permits the users of intraluminal imaging systems to compare different sizes and landing zones for a stent, with enhanced speed, accuracy, and repeatability over what is possible in the existing art. 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). The technology can be used in either or both of veins and arteries, including coronary arteries. The stent placement comparison 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. For example, any type of angioplasty device, atherectomy device, or drug delivery device that comes in multiple length options could potentially benefit from this type of IVI planning software.

[0150] 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. OneDocket No. 2024PF00151 or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions. One general aspect includes an apparatus that includes a processor circuit configured for communication with an intravascular imaging catheter and a display, 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, where the blood vessel may include a lesion; generate, based on the plurality of intravascular images, a comparison view screen display for planning a stent to provide treatment for the lesion, where the comparison view screen display may include a first stent option area and a second stent option area, where the first stent option area and the second stent option area are displayed simultaneously on a single screen; and output the comparison view screen display to the display, where the first stent option area may include: a visual representation of the blood vessel; a first virtual stent overlaid on the visual representation and may include a first stent length; and at least one of: one or more first intravascular images associated with the first stent length; or one or more first metrics associated with the first stent length. The second stent option area may include: the visual representation of the blood vessel; a second virtual stent overlaid on the visual representation and may include a different, second stent length; and at least one of: one or more second intravascular images associated with the second stent length; or one or more second metrics associated with the second stent length. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0151] Implementations may include one or more of the following features. In some aspects, the the first stent length and the second stent length are whole numbers such that the first stent length and the second stent length are distinct from a non-whole number length of the lesion. In some aspects, the second stent option area may include an input field, where the processor circuit is configured to receive a user input selecting the second stent length via the input field. In some aspects, the processor circuit is configured to receive, via the input field, an additional user input selecting a third stent length, where, in response to the additional user input, the processor circuit is configured to modify the second stent option area to reflect a change from the second stent length to the third stent length. In some aspects, to modify the second stent option area, theDocket No. 2024PF00151 processor circuit is configured to: modify the second virtual stent that is overlaid on the visual representation to have the third stent length; and at least one of: modify the one or more second intravascular images to be associated with the third stent length; or modify the one or more second metrics to be associated with the third stent length. In some aspects, the first virtual stent may include a first proximal landing zone and a first distal landing zone, where the one or more first intravascular images may include an intravascular image depicting the first proximal landing zone and an intravascular image depicting the first distal landing zone. In some aspects, the first virtual stent may include a first proximal landing zone and a first distal landing zone, where the one or more first metrics may include: at least one of a lumen metric or a vessel metric representative of the first proximal landing zone; and at least one of a lumen metric or a vessel metric representative of the first distal landing zone. In some aspects, the one or more first metrics and the one or more second metrics may include a plaque burden. In some aspects, the first virtual stent may include a first location along the blood vessel in the visual representation, where at least one of: the one or more first intravascular images are associated with the first location; or the one or more first metrics are associated with the first location, where the second virtual stent may include a different, second location along the blood vessel in the visual representation, where at least one of: the one or more second intravascular images are associated with the second location; or the one or more second metrics are associated with the second location. In some aspects, the processor circuit is configured to receive a user input on the second virtual stent to move the second virtual stent from the second location to a third location, where, in response to the user input, the processor circuit is configured to modify the second stent option area to reflect the change from the second location to the third location. In some aspects, to modify the second stent option area, the processor circuit is configured to: modify the second virtual stent to be overlaid on the visual representation in the third location; and at least one of: modify the one or more second intravascular images to be associated with the third location; or modify the one or more second metrics to be associated with the third location. In some aspects, the processor circuit is configured to transition to the comparison view screen display from another screen display that does not display the first stent option area and the second stent option area simultaneously on the single screen. In some aspects, the processor circuit is configured to receive a user input to initiate the transition from the another screen display to the comparison view screen display. In some aspects, the another screen display mayDocket No. 2024PF00151 include: only one of: the one or more first intravascular images associated with the first stent length; or the one or more second intravascular images associated with the second stent length; and only one of: the one or more first metrics associated with the first stent length; or the one or more second metrics associated with the second stent length. In some aspects, the another screen display may include neither the first virtual stent nor the second virtual stent. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0152] 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; based on the plurality of intravascular images: select a first stent size from a list of available stent sizes; select a first proximal landing zone and first distal landing zone for the first stent size; select a second stent size from the list of available stent sizes; select a second proximal landing zone and a second distal landing zone for the second stent size; output a screen display for stent planning, where the screen display may include: a visual representation of the blood vessel; and: a virtual stent of the first stent size overlaid on the visual representation between the first proximal landing zone and the first distal landing zone, along with first vessel metrics or lumen metrics associated with the first proximal landing zone and the first distal landing zone; or a virtual stent of the second stent size overlaid on the visual representation between the second proximal landing zone and the second distal landing zone, along with second vessel metrics or lumen metrics associated with the second proximal landing zone and the second distal landing zone. Other embodiments of this aspect include corresponding computer systems, apparatus, and computer programs recorded on one or more computer storage devices, each configured to perform the actions of the methods.

[0153] Implementations may include one or more of the following features. In some aspects, the list of available stent sizes is a manufacturer-maintained list or a user-maintained list. In some aspects, selecting the first stent size or the second stent size from the list of available stent sizes involves receiving a user input. In some aspects, selecting the first stent size or the second stent size is performed automatically. In some aspects, selecting the first proximal landing zone, the first distal landing zone, the second proximal landing zone, or the second distal landing zoneDocket No. 2024PF00151 involves receiving a user input. In some aspects, selecting the first proximal landing zone, the first distal landing zone, the second proximal landing zone, or the second distal landing zone is performed automatically. In some aspects, the screen display may include: a virtual stent of the first stent size overlaid on the visual representation between the first proximal landing zone and the first distal landing zone, along with first vessel metrics or lumen metrics associated with the first proximal landing zone and the first distal landing zone; and a virtual stent of the second stent size overlaid on the visual representation between the second proximal landing zone and the second distal landing zone, along with second vessel metrics or lumen metrics associated with the second proximal landing zone and the second distal landing zone. In some aspects, the screen display further may include: an intravascular image corresponding to the first proximal landing zone and an intravascular image corresponding to the first distal landing zone; or an intravascular image corresponding to the second proximal landing zone and an intravascular image corresponding to the second distal landing zone. In some aspects, the screen display further may include: an intravascular image corresponding to the first proximal landing zone and an intravascular image corresponding to the first distal landing zone; and an intravascular image corresponding to the second proximal landing zone and an intravascular image corresponding to the second distal landing zone. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0154] The logical operations making up the aspects of the technology described herein are referred to variously as operations, steps, objects, elements, components, modules, etc. Furthermore, it should be understood that these may occur or be performed or arranged in any order, unless explicitly claimed otherwise or a specific order is inherently necessitated by the claim language.

[0155] All directional references e.g., upper, lower, inner, outer, upward, downward, left, right, lateral, front, back, top, bottom, above, below, vertical, horizontal, clockwise, counterclockwise, proximal, and distal are only used for identification purposes to aid the reader’s understanding of the claimed subject matter, and do not create limitations, particularly as to the position, orientation, or use of the stent placement comparison system. Connection references, e.g., attached, coupled, connected, joined, or “in communication with” are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection referencesDocket No. 2024PF00151 do not necessarily imply that two elements are directly connected and in fixed relation to each other. The term “or” shall be interpreted to mean “and / or” rather than “exclusive or.” The word “comprising” does not exclude other elements or steps, and the indefinite article “a” or “an” does not exclude a plurality. Unless otherwise noted in the claims, stated values shall be interpreted as illustrative only and shall not be taken to be limiting.

[0156] The above specification, examples and data provide a complete description of the structure and use of exemplary aspects of the stent placement comparison system as defined in the claims. Although various aspects of the claimed subject matter have been described above with a certain degree of particularity, or with reference to one or more individual aspects, those skilled in the art could make numerous alterations to the disclosed aspects without departing from the spirit or scope of the claimed subject matter.

[0157] Still other aspects are contemplated. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative only of particular aspects and not limiting. Changes in detail or structure may be made without departing from the basic elements of the subject matter as defined in the following claims.

Claims

Docket No. 2024PF00151CLAIMSWhat is claimed is:

1. An apparatus, comprising: a processor circuit configured for communication with an intravascular imaging catheter and a display, 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, wherein the blood vessel comprises a lesion; generate, based on the plurality of intravascular images, a comparison view screen display for planning a stent to provide treatment for the lesion, wherein the comparison view screen display comprises a first stent option area and a second stent option area, wherein the first stent option area and the second stent option area are displayed simultaneously on a single screen; and output the comparison view screen display to the display, wherein the first stent option area comprises: a visual representation of the blood vessel; a first virtual stent overlaid on the visual representation and comprising a first stent length; and at least one of: one or more first intravascular images associated with the first stent length; or one or more first metrics associated with the first stent length, and wherein the second stent option area comprises: the visual representation of the blood vessel; a second virtual stent overlaid on the visual representation and comprising a different, second stent length; and at least one of: one or more second intravascular images associated with the second stent length; orDocket No. 2024PF00151 one or more second metrics associated with the second stent length.

2. The apparatus of claim 1 , wherein the first stent length and the second stent length are whole numbers such that the first stent length and the second stent length are distinct from a non-whole number length of the lesion.

3. The apparatus of claim 1, wherein the second stent option area comprises an input field, wherein the processor circuit is configured to receive a user input selecting the second stent length via the input field.

4. The apparatus of claim 3, wherein the processor circuit is configured to receive, via the input field, an additional user input selecting a third stent length, wherein, in response to the additional user input, the processor circuit is configured to modify the second stent option area to reflect a change from the second stent length to the third stent length.

5. The apparatus of claim 4, wherein, to modify the second stent option area, the processor circuit is configured to: modify the second virtual stent that is overlaid on the visual representation to have the third stent length; and at least one of: modify the one or more second intravascular images to be associated with the third stent length; or modify the one or more second metrics to be associated with the third stent length.

6. The apparatus of claim 1, wherein the first virtual stent comprises a first proximal landing zone and a first distal landing zone,Docket No. 2024PF00151 wherein the one or more first intravascular images comprises an intravascular image depicting the first proximal landing zone and an intravascular image depicting the first distal landing zone.

7. The apparatus of claim 1, wherein the first virtual stent comprises a first proximal landing zone and a first distal landing zone, wherein the one or more first metrics comprises: at least one of a lumen metric or a vessel metric representative of the first proximal landing zone; and at least one of a lumen metric or a vessel metric representative of the first distal landing zone.

8. The apparatus of claim 1, wherein the one or more first metrics and the one or more second metrics comprises a plaque burden.

9. The apparatus of claim 1, wherein the first virtual stent comprises a first location along the blood vessel in the visual representation, wherein at least one of: the one or more first intravascular images are associated with the first location; or the one or more first metrics are associated with the first location, wherein the second virtual stent comprises a different, second location along the blood vessel in the visual representation, wherein at least one of: the one or more second intravascular images are associated with the second location; or the one or more second metrics are associated with the second location.

10. The apparatus of claim 9,Docket No. 2024PF00151 wherein the processor circuit is configured to receive a user input on the second virtual stent to move the second virtual stent from the second location to a third location, wherein, in response to the user input, the processor circuit is configured to modify the second stent option area to reflect the change from the second location to the third location.

11. The apparatus of claim 10, wherein, to modify the second stent option area, the processor circuit is configured to: modify the second virtual stent to be overlaid on the visual representation in the third location; and at least one of: modify the one or more second intravascular images to be associated with the third location; or modify the one or more second metrics to be associated with the third location.

12. The apparatus of claim 1, wherein the processor circuit is configured to transition to the comparison view screen display from another screen display that does not display the first stent option area and the second stent option area simultaneously on the single screen.

13. The apparatus of claim 12, wherein the processor circuit is configured to receive a user input to initiate the transition from the another screen display to the comparison view screen display.

14. The apparatus of claim 12, wherein the another screen display comprises: only one of: the one or more first intravascular images associated with the first stent length; or the one or more second intravascular images associated with the second stent length; and only one of: the one or more first metrics associated with the first stent length; or the one or more second metrics associated with the second stent length.Docket No. 2024PF0015115. The apparatus of claim 12, wherein the another screen display comprises neither the first virtual stent nor the second virtual stent.

16. A 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; based on the plurality of intravascular images: select a first stent size from a list of available stent sizes; select a first proximal landing zone and first distal landing zone for the first stent size; select a second stent size from the list of available stent sizes; select a second proximal landing zone and a second distal landing zone for the second stent size; output a screen display for stent planning, wherein the screen display comprises: a visual representation of the blood vessel; and: a virtual stent of the first stent size overlaid on the visual representation between the first proximal landing zone and the first distal landing zone, along with first vessel metrics or lumen metrics associated with the first proximal landing zone and the first distal landing zone; or a virtual stent of the second stent size overlaid on the visual representation between the second proximal landing zone and the second distal landing zone, along with second vessel metrics or lumen metrics associated with the second proximal landing zone and the second distal landing zone.

17. The system of claim 16, wherein the list of available stent sizes is a manufacturer- maintained list or a user-maintained list.Docket No. 2024PF0015118. The system of claim 16, wherein selecting the first stent size or the second stent size from the list of available stent sizes involves receiving a user input.

19. The system of claim 16, wherein selecting the first stent size or the second stent size is performed automatically.

20. The system of claim 16, wherein selecting the first proximal landing zone, the first distal landing zone, the second proximal landing zone, or the second distal landing zone involves receiving a user input.

21. The system of claim 16, wherein selecting the first proximal landing zone, the first distal landing zone, the second proximal landing zone, or the second distal landing zone is performed automatically.

22. The system of claim 16, wherein the screen display comprises: a virtual stent of the first stent size overlaid on the visual representation between the first proximal landing zone and the first distal landing zone, along with first vessel metrics or lumen metrics associated with the first proximal landing zone and the first distal landing zone; and a virtual stent of the second stent size overlaid on the visual representation between the second proximal landing zone and the second distal landing zone, along with second vessel metrics or lumen metrics associated with the second proximal landing zone and the second distal landing zone.

23. The system of claim 16, wherein the screen display further comprises: an intravascular image corresponding to the first proximal landing zone and an intravascular image corresponding to the first distal landing zone; or an intravascular image corresponding to the second proximal landing zone and an intravascular image corresponding to the second distal landing zone.Docket No. 2024PF0015124. The system of claim 16, wherein the screen display further comprises: an intravascular image corresponding to the first proximal landing zone and an intravascular image corresponding to the first distal landing zone; and an intravascular image corresponding to the second proximal landing zone and an intravascular image corresponding to the second distal landing zone.

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