Intravascular data-based treatment plan during delivery of treatment to blood vessel accompanying x-ray images without radiopaque contrast

Abstract

An apparatus includes a processor configured to receive a plurality of x-ray images obtained by an x-ray imaging device, where the plurality of x-ray images depicts a blood vessel of a patient without a contrast medium; and a treatment catheter during movement through the blood vessel. The processor is further configured to retrieve, from a memory in communication with the processor, a treatment plan distinct from an intravascular image and based on intravascular data previously acquired by an intravascular catheter or guidewire from the blood vessel; and co-registered to an x-ray image with the contrast medium inside the blood vessel. The processor is further configured to generate a screen display including the plurality of x-ray images without the contrast medium displayed successively during the movement of the treatment catheter; and a visual representation of the treatment plan overlaid on the plurality of x-ray images.

Description

INTRAVASCULAR D ATA-BASED TREATMENT PLAN DURING DELIVERY OF TREATMENT TO BLOOD VESSEL ACCOMPANYING X-RAY IMAGES WITHOUT RADIOPAQUE CONTRASTTECHNICAL FIELD

[0001] The present disclosure relates generally to treatment of a blood vessel with an impedance to blood flow (e.g., blockage, compression, etc.). In particular, the delivery of treatment can be guided during display of live x-ray images without contrast using an intravascular data-based treatment plan developed during a planning phase.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. Stenting often involves other imaging modalities, such as the use of x-rays.

[0004] 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.SUMMARY

[0005] The systems, methods, and devices for intravascular imaging, measurement of physiological variables, and co-registration with X-ray images, as described herein, align intravascular images from different phases of the treatment process. The present disclosure provides systems, devices, and methods to link up the saved data from the planning screen (e.g., intravascular data, such as intravascular imaging, pressure, and / or from co-registered to an angiographic x-ray image) and use it in concert with the live screen during stent placement (e.g., the fluoroscopic X-ray imaging screen), displaying the operator’s movement of the stent or treatment device through the vasculature. The present disclosure uses technology that allows a live display to show movement of a device along with a display of the IVUS images updated according to position of the markers on the treatment device. The present disclosure uses an IVUS recording to create a plan to be made available and used during deployment of the stent or treatment device. The plan can a collection of data created during the use of intravascular imaging or physiology software that is made usable during deployment of the stent or treatment device.

[0006] 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 image co-registration 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.BRIEF DESCRIPTION OF THE DRAWINGS

[0007] Illustrative aspects of the present disclosure will be described with reference to the accompanying drawings, of which:

[0008] Figure 1 is a schematic, diagrammatic view of an intraluminal imaging and treatment system, according to aspects of the present disclosure.

[0009] Figure 2 is a schematic diagram of a processor circuit, according to aspects of the present disclosure.

[0010] Figure 3 illustrates a blood vessel incorporating a plaque, according to aspects of the present disclosure.

[0011] Figure 4 illustrates a blood vessel incorporating a plaque and with a stent expanded inside it to restore flow, according to aspects of the present disclosure.

[0012] Figure 5 is a schematic diagram of a system for co-registering images before and after stent placement, according to aspects of the present disclosure.

[0013] Figure 6 is a schematic, diagrammatic representation, in flow diagram form, of an example treatment phase co-registration method, according to aspects of the present disclosure.

[0014] Figure 7 is an example data structure resulting from co-registration during treatment planning, according to aspects of the present disclosure.

[0015] Figure 8 is an angiographic roadmap image, according to aspects of the present disclosure.

[0016] Figure 9 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0017] Figure 10 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0018] Figure 11 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0019] Figure 12 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0020] Figure 13 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0021] Figure 14 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0022] Figure 15 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0023] Figure 16 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0024] Figure 17 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0025] Figure 18 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0026] Figure 19 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0027] Figure 20 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0028] Figure 21 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0029] Figure 22 is a screen display of an example co-registration system, according to aspects of the present disclosure.

[0030] Figure 23 is a screen display of an example co-registration system, according to aspects of the present disclosure.

[0031] Figure 24 is a representation of a screen display at two different times, according to aspects of the present disclosure.

[0032] Figure 25 is a representation of a screen display at two different times using motion compensation or image stabilization, according to aspects of the present disclosure.

[0033] Figure 26 is a screen display showing an image from the live, treatment phase fluoroscopy image stream side-by-side with a stabilized image, according to aspects of the present disclosure.

[0034] Figure 27 is a screen display showing an image from the live, treatment phase fluoroscopy image stream side-by-side with a stabilized, zoomed image, according to aspects of the present disclosure.

[0035] Figure 28 is an image from the live, treatment phase fluoroscopy image stream, according to aspects of the present disclosure.

[0036] Figure 29 is a schematic, diagrammatic representation of a catheter lab session, according to aspects of the present disclosure.

[0037] Figure 30 is an image from the live, treatment phase fluoroscopy image stream, coregistered with physiology data, according to aspects of the present disclosure.

[0038] Figure 31 is an image from the live, treatment phase fluoroscopy image stream, coregistered with physiology data, according to aspects of the present disclosure.

[0039] Figure 32 is a screen display of an example co-registration system, according to aspects of the present disclosure.

[0040] Figure 33 is a screen display of an example co-registration system, according to aspects of the present disclosure.

[0041] Figure 34 is a representation of a screen display at two different times, according to aspects of the present disclosure.

[0042] Figure 35 is a screen display showing an image from the live, treatment phase fluoroscopy image stream side-by-side with a stabilized, zoomed X-ray image, according to aspects of the present disclosure.

[0043] Figure 36 is an angiographic roadmap image, according to aspects of the present disclosure.

[0044] Figure 37 is a screen display of an example co-registration system, according to aspects of the present disclosure.

[0045] Figure 38 is a screen display of an example co-registration system, according to aspects of the present disclosure.

[0046] Figure 39 is a stent planning screen display of an example intravascular imaging system, according to aspects of the present disclosure.

[0047] Figure 40 is a is a stent planning screen display of an example intravascular physiology measurement system, according to aspects of the present disclosure.DETAILED DESCRIPTION

[0048] Currently interventional cardiologists can plan percutaneous coronary intervention (PCI) procedures using intravascular imaging with co-registration. This allows them to display intravascular images co-registered with their location on an x-ray angiogram within a single screen. This helps the operator to do virtual stenting and create a visual plan for treatment such as placement of a stent at the desired planned location in the diseased vessel. With the current solution, however, the operator’s active placement of the stent is visualized in a separate live imaging screen with no relation back to the planning screen. The operator can save a copy of the planning screen and display it next to the live screen, but has no way to marry the two.

[0049] The systems, methods, and devices for intravascular imaging and co-registration, as described herein, align intravascular images from different phases of the treatment process. For the sake of explanation, the description herein focuses on a stent placement procedure, but other treatments are conceived of and encompassed. To accomplish the alignment between intravascular imaging pullback before and after stent placement, regions of a blood vessel are identified that correspond to the same feature. For example, the contours of the blood vessel may used to match regions of equivalent contours. Many other features may be used, and many pairs of regions in pre-stent and post-stent pullbacks may be used to align images.

[0050] The present disclosure provides systems, devices, and methods to link up the saved data from the planning screen and use it in concert with the live screen (e.g., the fluoroscopic or angiographic X-ray imaging screen) displaying the operator’s movement of the stent or treatment device through the vasculature. The present disclosure uses technology that allows a live display to show movement of a device along with a display of the IVUS images updated according to position of the markers on the treatment device. The present disclosure uses an IVUS recording to create a plan to be made available and used during deployment of the stent or treatment device. The “plan” is a collection of data created during the use of intravascular imaging or physiology software that is made usable during deployment of the stent or treatment device. The plan created in the IVUS or physiology software can include: IVUS data, Physiology data, X-ray data, Co-registration data (e.g. IVUS co-registration to an angiogram), IVUS longitudinal data (e.g. plaque size, shape, and type), Physiology longitudinal data (e.g. iFR pullback data), Length measurements, including those made by software or by an external pullback or measurement device, Characteristics or settings that relate to the treatment device (e.g. intravascular lasersettings, inflation pressure, stent size and length, expected size and shape after expansion, etc.), and Segments of interest identified automatically by software or by the user.

[0051] During stent or therapy device deployment, the present disclosure involves displaying relevant plan data to the user. This may for example include alerting the user to the moment when the marker position becomes in line with the planned stent or treatment device position as determined earlier by the operator in the planning phase; visualizing a stent or treatment device as it advances through the IVUS or physiology longitudinal display; and / or comparing live stent expansion against anticipated stent expansion.

[0052] Examples of calculation or estimation of pullback speed (e.g., for use in coregistration calculations) can be found for example in U.S. Application No. 16 / 542,001, filed August 15, 2019, and U.S. Application No. 16 / 662,847, filed October 24, 2019, incorporated by reference as though fully set forth herein.

[0053] The devices, systems, and methods described herein can include one or more features described in U.S. Provisional App. No. 63 / 600,110, filed November 17, 2023, which is hereby incorporated by reference in its entirety as though fully set forth herein.

[0054] The devices, systems, and methods described herein can include one or more features described in U.S. Provisional App. No. 62 / 750,983, filed October 26, 2018, U.S. Provisional App. No. 62 / 751,268, filed October 26, 2018, U.S. Provisional App. No. 62 / 751,289, filed October 26, 2018, U.S. Provisional App. No. 62 / 750,996, filed October 26, 2018, U.S.Provisional App. No. 62 / 751,167, filed October 26, 2018, and U.S. Provisional App. No. 62 / 751,185, filed October 26, 2018, each of which is hereby incorporated by reference in its entirety as though fully set forth herein.

[0055] The devices, systems, and methods described herein can also include one or more features described in U.S. Provisional App. No. 62 / 642,847, filed March 14, 2018, U.S. Provisional App. No. 62 / 712,009, filed July 30, 2018, U.S. Provisional App. No. 62 / 711,927, filed July 30, 2018, and U.S. Provisional App. No. 62 / 643,366, filed March 15, 2018, each of which is hereby incorporated by reference in its entirety as though fully set forth herein.

[0056] These descriptions are provided for exemplary purposes only, and should not be considered to limit the scope of the intravascular imaging and co-registration system. Certain features may be added, removed, or modified without departing from the spirit of the claimed subject matter.

[0057] 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.

[0058] Figure 1 is a schematic, diagrammatic view of an intraluminal imaging and treatment system 100, according to aspects of the present disclosure. The intraluminal imaging system 100 can be an intravascular ultrasound (IVUS) or optical coherence tomography (OCT) imaging and treatment system in some 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. The system 100 may be deployed in a catheterization laboratory having a control room. 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.

[0059] In some aspects, the intraluminal imaging and treatment system 100 may include an intravascular imaging system 110, which may for example include an intravascular imaging catheter 102, with a flexible elongate member 104 and imaging element 112. The intravascular imaging catheter or intravascular device 102 is sized and shaped, and / or otherwise structurally arranged to be positioned within a blood vessel of a patient. It is understood that theintravascular imaging system 110 and / or intravascular imaging 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 IVUS, optical imaging, OCT, etc.

[0060] In some aspects, the intraluminal imaging and treatment system 100 may include an intravascular physiology measurement system 120, which includes an intravascular physiology measurement guidewire 122 with flexible elongate member 124 and a pressure sensor, flow sensor, or temperature sensor 126. The intravascular physiology measurement guidewire 122 is sized and shaped to be positioned within the blood vessel, and may for example be used to guide the intravascular imaging catheter 102 (or other catheters as described below) through the vessel.

[0061] The intraluminal imaging and treatment system 100 may include an X-ray imaging system 130, which may include an X-ray imaging device 132, which may include components such as a C-arm, emitter, receiver, etc. The X-ray imaging device 132 may be used for angiography, fluoroscopy, computed tomography (CT), or other imaging modalities. For example, the X-ray imaging system 130 can be configured to obtain single or multiple 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 blood vessel). The X-ray imaging system 130 may also be configured to obtain computed tomography images of the body of the patient (including the blood vessel). As described below, a processing system can utilize the images of the body of the patient in conjunction with intraluminal data points obtained by the intravascular devices 102 and / or 122.

[0062] In some aspects, the intraluminal imaging and treatment system 100 may include a stent delivery catheter 140, which may for example include a flexible elongate member 144, balloon 146, radiopaque markers 148, and stent 142. The stent delivery catheter 140 may for example deliver the stent 142 to a treatment site, where it is expanded by the balloon 146 in order to dilate a stenosed portion of the blood vessel.

[0063] In some aspects, the intraluminal imaging and treatment system 100 may include a laser atherectomy system 150, which includes a laser atherectomy catheter 152. The laser atherectomy catheter 152 includes a flexible elongate member 154, optical fiber(s) 156 for carrying laser light, and a radiopaque marker 158. The laser atherectomy catheter 152 may for example deliver the optical fiber(s) 156 to a treatment site, where laser light is used to ablate a stenosis in the blood vessel.

[0064] Figure IB is a schematic, diagrammatic view of a system 110, 120, 130, or 150, according to aspects of the present disclosure. The system 110, 120, 130, or 150 may for example be a console, cart, or computer for controlling an imaging, measurement, or treatment system as described above. In the example shown in Figure IB, the system 110, 120, 130, or 150 includes a processor circuit 160, a user input device 170, and a display 180.

[0065] These elements may be communicatively coupled to other systems 110, 120, 130, or 150 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 processor circuit 160 may also be communicatively coupled to one or more data networks, e.g., a TCP / IPbased local area network (LAN). In other aspects, different protocols may be utilized such as Synchronous Optical 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.

[0066] The controller or processor circuit 160 may include a processing circuit having one or more processors in communication with memory and / or other suitable tangible computer readable storage media. The processor circuit 160 may be configured to carry out one or more aspects of the present disclosure. In some aspects, the processor circuit 160 and the display 180 are separate components. In other aspects, the processor circuit 160 and the display 180 are integrated in a single component. For example, the system 110, 120, 130, or 150 can include a touch screen device, including a housing having a touch screen display and a processor. The system 110, 120, 130, or 150 can include any suitable input device 170, such as a touch sensitive pad or touch screen display, keyboard / mouse, joystick, button, etc., for a user to select options shown on the display 180. The processor circuit 160, the display or monitor 180, the input device 170, and / or combinations thereof can be referenced as a controller of the system 110, 120, 130, or 150. The controller can be in communication other components of the system 110, 120, 130, or 150.

[0067] The monitor or display 180 may be a display device such as a computer monitor or other type of screen. The display 180 may be used to display selectable prompts, instructions, and visualizations of imaging data to a user. In some aspects, the display 180 may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging and treatment procedure, as described below. This workflow may include performing a pre-stent plan to determine the state of a lumen and potential for a stent, placement of the stent, and / or a post-stent inspection to determine the status of a stent that has been positioned in the blood vessel.

[0068] 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 system 110, 120, 130, or 150, 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.

[0069] 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.

[0070] 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 includesa 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.

[0071] 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 system 110, 120, 130, or 150. The communication module 268 may communicate within the processor circuit 250 through numerous methods or protocols. Serial communication protocols may include but are not limited to United States Serial Protocol Interface (US SPI), Inter-Integrated Circuit (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.

[0072] 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 mobiletelecommunications 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.

[0073] 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. The processing components of the system can be integrated within the ultrasound imaging device, contained within an external console, or may be a separate component.

[0074] Figure 3 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.

[0075] 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.

[0076] 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)

[0077] 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.

[0078] Figure 4 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.

[0079] 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.

[0080] Figure 5 is a schematic, diagrammatic representation of a catheter lab session 500, according to aspects of the present disclosure. Figure 5 includes steps associated with two phases: a pre-stent placement phase or planning phase 502, and a stent placement phase or treatment phase 504. Imaging associated with pre-stent placement 502 may facilitate stentplacement planning, including location and mapping out the diseased regions of a blood vessel, e.g., 350 as described in Figure 3. Imaging associated with stent placement 504 may allow a physician or other medical professional to track, in real-time, the path of the stent as it traverses the vasculature towards the targeted diseased region, and also to evaluate the success of the stent placement procedure in real time. For example, stent placement imaging may show a plaque that has shifted, a stent that has failed to completely inflate, damage to the surrounding tissue, etc. In each of the two phases, pre-stent or planning 502 and stent placement or treatment 504, X-ray imaging, with or without contrast, may be utilized. In the pre-stent phase 502, intravascular imaging may be utilized.

[0081] The pre-stent phase or planning phase 502 may include X-ray imaging 508, intravascular imaging pullback 510, and single-frame x-ray imaging 515 (see Figure 39). X-ray imaging 508 may include multiple X-ray frames without the use of contrast agent to facilitate real-time imaging, i.e., fluoroscopy. In X-ray imaging 508, an intravascular imaging catheter present in the vasculature is visible. Intravascular imaging pullback 510 may include a pullback procedure whereby data for multiple intravascular imaging frames may be acquired. In intravascular imaging 510, various aspects of the vasculature, including vessel features and contours as described herein, are visible. Single frame x-ray imaging 515 may include a single x- ray frame with contrast, i.e., an angiogram, wherein the vasculature is visible.

[0082] From the images generated during the pre-stent phase 502, a co-registration 580 between the intravascular imaging pullback 510 and the single-frame x-ray imaging (e.g., an angiogram) 515 may be performed. For example, each frame of the intravascular imaging pullback may be associated with a point along a blood vessel as depicted in an angiogram 515. Co-registration between an intravascular imaging pullback and angiogram is further described in U.S. Patent No. 7,930,014, titled “Vascular image co-registration”, and U.S. Publication No. 2012 / 0004537, titled “Co-use of endoluminal data and extraluminal imaging”, each of which is incorporated by reference as though fully set forth herein.

[0083] The intravascular imaging pullback 510 can also provide a longitudinal view 520, also known as an image longitudinal display or ILD, which allows a clinician to see, at a glance, features of the blood vessel along the imaged length. The intravascular imaging pullback 510 can also provide metrics 530 from the intravascular imaging frames. These metrics 530 nay for example be based on border detection for the vessel border and / or lumen border, and mayinclude lumen area, vessel area, limen diameter, vessel diameter, and / or an occlusion value (e.g., plaque burden, percent stenosis). Aspects of detecting a lumen border and / or a vessel border and / or calculating lumen / vessel dimensions based on the detected borders are described in U.S. Publication No. 2007 / 0201736, U.S. Patent No. 11,272,845, U.S. Patent No. 7,463,759, U.S. Patent No. 9,295,447, U.S. Patent No. 11,744,527, U.S. Publication No. 2020 / 0029932, U.S. Publication No. 2019 / 0282211, each of which is hereby incorporated by reference as though fully set forth herein.

[0084] The intravascular imaging pullback 510 can also provide a treatment plan 540. In the case of a stenting procedure, the treatment plan 540 may for example include the target location, proximal stent landing zone, and distal stent landing zone, which (depending on the implementation) may be calculated automatically by the system, may be calculated or recalculated at least in part based on inputs from the user, or may be manually selected by the user. In the case of a laser atherectomy treatment, the treatment plan 540 may include the target location, proximal border of the atherectomy treatment zone, and distal border of the atherectomy treatment zone.

[0085] The stent placement phase or treatment phase 504 may include real-time x-ray imaging 550. Real-time x-ray imaging 550 may done without a contrast agent. X-ray imaging 550, also referred to as fluoroscopy, may allow a physician or other medical profession to view the progress of a stent or atherectomy treatment device through a blood vessel as it is delivered to a target location.

[0086] From the images generated during pre-stent phase or planning phase 502, a coregistration 580 between the intravascular imaging pullback 510 and the single-frame X-ray imaging (e.g., an angiogram) 515 may be performed. For example, the ILD 520, metrics 530, or treatment plan associated with the image frames of the intravascular imaging pullback 515 may be associated with a point along the blood vessel as depicted in the angiogram 515.

[0087] From the images generated during the pre-stent phase 502, a co-registration 585 between the intravascular pullback images 510 and pre-stent angiogram 515 may be performed. For example, each frame of the intravascular imaging pullback 510 may be associated with a point along a blood vessel as depicted in an angiogram 515.

[0088] Similarly, during the treatment phase or stent placement phase 504, a co-registration 590 between the intravascular pull images 510 and the live fluoroscopy imaging 550 may beperformed. For example, each frame of the intravascular imaging pullback 510 may be associated with a point along a blood vessel as depicted in the fluoroscopy images 550.

[0089] As described herein, various features of the vasculature, user-provided markers, and plaque may be used to align the pre-stent pullback 510 with the X-ray imaging 515, 550. In some instances, this has the benefit of reducing the amount of X-ray imaging required and thus the radiation exposure of the patient subject to the imaging procedure. One of the challenges with co-registering with the live fluoroscopic image stream 550 is the movement of the blood vessel due to beating of the heart, as described below.

[0090] Figure 6 is a schematic, diagrammatic representation, in flow diagram form, of an example treatment phase co-registration method 600, according to aspects of the present disclosure. It is understood that the steps of method 600 may be performed in a different order than shown in Figure 6, additional steps can be provided before, during, and after the steps, and / or some of the steps described can be replaced or eliminated in other embodiments. One or more of steps of the method 600 can be carried by one or more devices and / or systems described herein, such as components of the system 100 and / or processor circuit 250.

[0091] In step 610, the method 600 includes obtaining a stream of X-ray image frames without contrast (e.g., a fluoroscopic image stream) during movement of a treatment catheter (e.g., a stent delivery catheter or laser atherectomy catheter) within a blood vessel. Execution then proceeds to step 620.

[0092] In step 620, the method 600 includes tracking the current position(s) of the treatment catheter (e.g., the positions of one or more radiopaque markings on the treatment catheter) within the blood vessel during movement of the catheter. Execution then proceeds to step 630.

[0093] In step 630, the method 600 includes comparing the current position(s) of the treatment catheter to stored positions from treatment planning (e.g., the stored positions of the proximal and distal stent landing sites). In an example the comparison is between the current position(s) of treatment catheter (position along the X-ray images without contrast, during treatment) and the position(s) position along the X-ray image with contrast, from treatment planning. For example, the comparison can be performed because the patient has not moved and / or C-arm orientation has not changed from the X-ray image obtained during treatment planning. Alternatively, if the C-arm has moved, the C-arm orientation is stored, so that the X-ray imaging system can go back to that stored C-arm orientation. Execution then proceeds to step 640.

[0094] In step 640, the method 600 includes retrieving stored information (different than the IVI images) associated with the stored position(s), based on the current treatment catheter position(s). The stored information may for example include vessel metrics as described above. Execution then proceeds to step 650.

[0095] In step 650, the method 600 includes outputting a screen display with the live X-ray image frames without contrast (e.g., the fluoroscopic image stream), along with the co-registered stored positions and / or stored information. The method 600 is now complete.

[0096] 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.

[0097] 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 several hundred, several thousand, several million, or several billion per second, in a single processor or across a plurality of processors. Such rapid execution may be necessary in order to execute the method in real time or near-real time as described herein. For example, co-registration of IVI- obtained data with the moving images of the live fluoroscopic display may require completing the co-registration calculations at a frequency of at least 30 Hz and preferably at least 120 Hz.

[0098] It is noted that the flow diagram of Figure 6 applies equally to intravascular imaging and physiology measurement for the planning of treatment using any type of intravascular treatment device.

[0099] Figure 7 is an example data structure resulting from co-registration during treatment planning, according to aspects of the present disclosure. In the example shown in Figure 7, the data structure 700 includes intravascular image frames, along with their corresponding locations in the angiographic roadmap image (e.g., the single X-ray frame, taken with contrast) and thelongitudinal view or ILD. The data structure 700 also includes the associated vessel and / or lumen borders associated with each frame, vessel metrics and / or lumen metrics derived from the border(s) as described above. The data structure 700 also includes the treatment plan, e.g., the frame numbers associated with the treatment end or distal landing zone (e.g., the landing zone for the distal end of the stent) and the treatment start or proximal landing zone (e.g., the landing zone for the proximal end of the stent). The data structure 700 also includes other information associated with the intravascular image frames, including for example which frame is the start of the pullback, which frame is the distal reference frame, which frame is the target frame, which frame is the proximal reference frame, which frames are bookmarked (e.g., locations of suspected bifurcations, etc.), and which frame is the end of the pullback.

[0100] It is noted that the treatment start and treatment end locations may not line up precisely with the proximal and distal reference frames. For example, if the distance between the proximal and distal reference frames is not equal to any of the available commercial stent sizes, then the positions of one or both of the treatment start and treatment end locations may need to be adjusted by the clinician (e.g., by repositioning a virtual stent as described for example in U.S. Provisional Application No. 63 / 550,709, filed February 7, 2024, titled “INTRAVASCULAR IMAGING FOR STENT PLANNING WITH SIMULTANEOUS LANDING ZONE ADJUSTMENT AND VISUALIZATION”, which is incorporated by reference as though fully set forth herein).

[0101] Figure 8 is an angiographic roadmap image 515, according to aspects of the present disclosure. In an example, the angiographic roadmap image is a single X-ray image taken with contrast during the treatment planning phase, showing the vessel 300 along with co-registration of the start 810 and end 820 of the pullback, along with a plurality of endoluminal or intravascular data points 830. The data points 830 may be or include any of the data from any column of the data structure of Figure 7, such as image data, image frame data, location data, vessel and / or lumen borders, vessel and / or lumen metrics, treatment plan data, or other information. The angiographic roadmap image 515 may be used, alone or in conjunction with the longitudinal view or ILD 520 (see Figure 5), for treatment planning.

[0102] Figure 9 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. No contrast agent is used in the treatment phase fluoroscopy image stream 550, so while the vessel 300, vessel walls 310, and vessel lumen 315are shown in Figure 9, it is understood that they are not actually visible to the clinician in the live, treatment phase fluoroscopy image stream 550. Other features are visible, including a stent placement catheter 140, stent 142, and radiopaque markings 148. The stent 142 may for example be placed around a balloon 146, and the radiopaque markings 148 may be positioned on the balloon 146, the stent 142, or both. The darkness of features in Figure 9 is roughly equivalent to how things will appear in the X-ray image, e.g., the stent 142 is more visible than the catheter 140, and the radiopaque markings 148 are more visible than the stent. A treatment plan overlay indicator 910 shows that treatment plan overlays are turned off.

[0103] Figure 10 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. Visible are the blood vessel 300, stent placement catheter 140, stent / balloon 142, 146, and radiopaque markings 148. The treatment plan overlay indicator 1110 shows that treatment plan overlays are turned on. As a result, the co-registered distal landing zone 344 and proximal landing zone 346 are visible on the treatment phase fluoroscopy image stream 550. Since the clinician can see the co-registered distal landing zone 344 and proximal landing zone 346 on the X-ray screen, the landing zones can guide the clinician to advance the stent placement catheter 140 until the radiopaque markings 148 line up with the landing zones 344, 346, thus ensuring proper placement of the stent in order to treat the stenosis (see Figures 3 and 4).

[0104] Figure 11 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. Visible are the blood vessel 300, stent placement catheter 140, stent / balloon 142, 146, radiopaque markings 148, treatment plan overlay indicator 1110, and co-registered distal landing zone 344 and proximal landing zone 346. In the example shown in Figure 11, the clinician has advanced the stent placement catheter 140 until the radiopaque markings 148 are aligned with the co-registered distal landing zone 344 and proximal landing zone 346. Thus, the clinician can surmise that the stent is in the proper position and can be expanded to dilate the stenosis, as shown in Figure 4.

[0105] Figure 12 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. Visible are the blood vessel 300, stent placement catheter 140, stent / balloon 142, 146, radiopaque markings 148, treatment plan overlay indicator 1110, and co-registered distal landing zone 344 and proximal landing zone 346. In the example shown in Figure 12, because the clinician has advanced the stent placement catheter 140 until theradiopaque markings 148 are aligned with the co-registered distal landing zone 344 and proximal landing zone 346, the co-registered distal landing zone 344 and proximal landing zone 346 have changed appearance (e.g., changed color, thickness, brightness, or other visual feature). Thus, the clinician can surmise that the stent is in the proper position and can be expanded to dilate the stenosis, as shown in Figure 4.

[0106] Figure 13 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. Visible are the blood vessel 300, stent placement catheter 140, stent / balloon 142, 146, radiopaque markings 148, treatment plan overlay indicator 1110, and co-registered distal landing zone 344 and proximal landing zone 346. Also visible is an engagement signal 1310, which shows an indicator (e.g., a yellow light) that the radiopaque markings 148 are not aligned with the co-registered distal landing zone 344 and proximal landing zone 346.

[0107] Figure 14 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. Visible are the blood vessel 300, stent placement catheter 140, stent / balloon 142, 146, radiopaque markings 148, treatment plan overlay indicator 1110, and co-registered distal landing zone 344 and proximal landing zone 346. Also visible is the engagement signal 1310, which shows an indicator (e.g., a green light) that the radiopaque markings 148 are aligned with the co-registered distal landing zone 344 and proximal landing zone 346. A clinician may therefore surmise that the stent is in the proper position for expansion.

[0108] Figure 15 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. Visible are the blood vessel 300, stent placement catheter 140, stent / balloon, radiopaque markings 148, and treatment plan overlay indicator 910. Also visible are a co-registered distal landing zone region 1544 and proximal landing zone region 1546. The landing zone regions 1544, 1546 each indicate multiple locations along the vessel where the respective stent ends may be placed, thus providing more flexibility to the clinician for placing the stent. Also visible are a distal engagement signal 1545 and a proximal engagement signal 1547, each of which shows an indicator (e.g., a yellow light) that the radiopaque markings 148 are not aligned with the co-registered distal landing zone region 1544 and proximal landing zone region 1546.

[0109] Figure 16 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. Visible are the blood vessel 300, stent placement catheter 140, stent / balloon, radiopaque markings 148, and treatment plan overlay indicator 910. Also visible are the co-registered distal landing zone region 1544 and proximal landing zone region 1546. Also visible is the distal engagement signal 1545 which shows an indicator (e.g., a green light) that the distal-most radiopaque marking 148 is located within the co-registered distal landing zone region 1544. However, the proximal engagement signal 1547 shows an indicator (e.g., a yellow light) that the proximal -most radiopaque marking is not within the co-registered proximal landing zone region 1546. Thus, a clinician may surmise that the stent is not yet in the proper position.

[0110] Figure 17 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. Visible are the blood vessel 300, stent placement catheter 140, stent / balloon, radiopaque markings 148, and treatment plan overlay indicator 910. Also visible are a co-registered distal landing zone region 1544 and proximal landing zone region 1546. Also visible are the distal engagement signal 1545 and proximal engagement signal 1547, each of which shows an indicator (e.g., a green light) that the radiopaque markings 148 fall within the co-registered distal landing zone region 1544 and proximal landing zone region 1546. The clinician may thus surmise that the stent is in the proper position for expansion.

[0111] Figure 18 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. Visible are the blood vessel 300, stent placement catheter 140, stent / balloon, radiopaque markings 148, and treatment plan overlay indicator 910. Also visible are annotations 1800, indicating the co-registered positions of a bookmarked frame (e.g., a suspected bifurcation), the proximal reference frame, the target frame, and the distal reference frame, as well as the distance between the proximal reference frame and the distal reference frame, which may for example be the length that must be covered by any stent selected by the clinician during the treatment planning phase. In the example shown in Figure 18, the radiopaque markings 148 are not yet aligned with the proximal reference frame and distal reference frame.

[0112] Figure 19 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. Visible are the blood vessel 300, stent placement catheter 140, stent / balloon, radiopaque markings 148, and treatment plan overlay indicator 910.Also visible are annotations 1800, indicating the co-registered positions of a bookmarked frame (e.g., a suspected bifurcation), the proximal reference frame, the target frame, and the distal reference frame, as well as the distance between the proximal reference frame and the distal reference frame. In the example shown in Figure 19, the radiopaque markings 148 are aligned with the proximal reference frame and distal reference frame. A clinician may thus surmise that the stent is in the correct position for expansion.

[0113] Figure 20 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. Visible are the blood vessel 300, stent placement catheter 140, stent 142 / balloon 146, radiopaque markings 148, and treatment plan overlay indicator 910. Also visible are a proximal vessel metric report 2010 and distal metric report 2020, corresponding to the proximal and distal radiopaque markings 148. In the example shown in Figure 20, the reported metric is plaque burden, and a threshold value 2030 is set to 20%. The proximal vessel metric report 2010 indicates that the proximal radiopaque marker is at a location in the blood vessel with a 35% plaque burden. Since this is above the plaque burden threshold of 20%, the distal vessel metric report 2020 is not highlighted (e.g., brightened, bolded, colored green, or otherwise), and a proximal checkbox indicator 2040 displays an “X”, indicating that the proximal radiopaque marker 148 is not in a suitable location.

[0114] Conversely, the distal vessel metric report 2020 indicates that the distal radiopaque marker is at a location in the blood vessel with an 18% plaque burden. Since this is below the plaque burden threshold of 20%, the distal vessel metric report 2020 is highlighted (e.g., brightened, bolded, colored green, or otherwise), and a distal checkbox indicator 2050 displays a check mark, indicating that the distal radiopaque marker 148 is in a suitable location.

[0115] Figure 21 is an image from the live, treatment phase fluoroscopy image stream 550, according to aspects of the present disclosure. Visible are the blood vessel 300, stent placement catheter 140, stent 142 / balloon 146, radiopaque markings 148, and treatment plan overlay indicator 910. Also visible are the proximal vessel metric report 2010 and distal metric report 2020. The proximal vessel metric report 2010 indicates that the proximal radiopaque marker is at a location in the blood vessel with an 18% plaque burden. Since this is below the plaque burden threshold of 20%, the distal vessel metric report 2020 is highlighted (e.g., brightened, bolded, colored green, or otherwise), and the proximal checkbox indicator 2040 displays a check mark, indicating that the proximal radiopaque marker 148 is in a suitable location.

[0116] Similarly, the distal vessel metric report 2020 indicates that the distal radiopaque marker is at a location in the blood vessel with an 15% plaque burden. Since this is below the plaque burden threshold of 20%, the distal vessel metric report 2020 is highlighted (e.g., brightened, bolded, colored green, or otherwise), and a distal checkbox indicator 2050 displays a check mark, indicating that the distal radiopaque marker 148 is also in a suitable location.

[0117] Since both radiopaque markers 148 are located in suitable (e.g., low-plaque-burden) locations along the blood vessel, the clinician may surmise that the stent is in a suitable location to be dilated by the balloon 146 (e.g., that the stent fully covers the stenosed region and extends outward to healthy vascular tissue).

[0118] Figure 22 is a screen display 2200 of an example co-registration system, according to aspects of the present disclosure. The screen display 2200 includes an image from the live, treatment phase fluoroscopy image stream 550, in which the blood vessel 300, stent placement catheter 140, stent 142 / balloon 146, and radiopaque markings 148 are visible. Also visible are the proximal metric report 2010 and distal metric report 2020 as described above.

[0119] The screen display 2200 includes a longitudinal view, image longitudinal display, or ILD 520, which may for example be assembled from longitudinal cross-sections of the intravascular images captured by the intravascular imaging catheter. The ILD 520 shows the blood vessel 300, vessel walls 310, vessel lumen 315, distal landing zone 344, proximal landing zone 346, distance indicator 2210, and co-registered radiopaque markers 148. The ILD 520 makes it possible for the clinician to see, at a glance, the diameter of the blood vessel 300 at different locations along its length, such that a plaque or stenosis 330 is clearly visible.

[0120] The present disclosure provides for displaying the co-registered radiopaque markers on the ILD 520, thus allowing the clinician to clearly visualize the movement of the stent with respect to the stenosis 330 and the landing zones 344, 346.

[0121] Figure 23 is a screen display 2200 of an example co-registration system, according to aspects of the present disclosure. The screen display 2200 includes an image from the live, treatment phase fluoroscopy image stream 550, in which the blood vessel 300, stent placement catheter 140, stent 142 / balloon 146, and radiopaque markings 148 are visible. Also visible are the proximal metric report 2010 and distal metric report 2020 as described above.

[0122] The screen display 2200 includes a longitudinal view, image longitudinal display, or ILD 520, in which the radiopaque markers 148 can be seen to overlap with the distal landingzone 344 and proximal landing zone 346. As a result, the distal landing zone 344 and proximal landing zone 346 have been highlighted (e.g., brightened, darkened, bolded, colored green, or otherwise). The clinician may therefore surmise that the stent is in a suitable location to be dilated by the balloon 146 (e.g., that the stent fully covers the stenosed region and extends outward to healthy vascular tissue).

[0123] Figure 24 is a representation 2400 of a screen display 2200 at two different times, according to aspects of the present disclosure. In the first screen display 2200-1 at a first time, the stent placement catheter 140 is in a first position along the blood vessel 300, and the blood vessel 300 is also in a first position. In the second screen display 2200-2 at a second time, the stent placement catheter 140 is in a different, second position along the blood vessel 300, e.g., because the clinician has advanced it toward the landing zones 344, 346. However, the blood vessel 300 is also in a different, second position within the screen display 2200-2, because cardiac motion (e.g., the beating of the heart) has induced motion of the blood vessel.

[0124] In the example shown in Figure 24, the co-registered landing zones 344, 346 and move along with the vessel 300.

[0125] Figure 25 is a representation 2400 of a screen display 2200 at two different times using motion compensation or image stabilization, according to aspects of the present disclosure. In the first screen display 2200-1, the stent placement catheter 140 is in a first position along the blood vessel 300, and the blood vessel 300 is also in a first position. In the second screen display 2200-2, the stent placement catheter 140 is in a different, second position along the blood vessel 300, e.g., because the clinician has advanced it toward the landing zones 344, 346. However, the blood vessel 300 remains in the first position within the screen display 2200-2, because motion compensation or image stabilization has compensated for the cardiac motion (e.g., the beating of the heart) such that the physical motion of the blood vessel within the patient’s body does not result in motion of the blood vessel on the screen display 2200-2. Descriptions of motion compensation can be found for example in U.S. Patent No. 11,197,651, titled “Identification and presentation of device-to-vessel relative motion”, U.S. Patent No. 9,659,375, titled “Methods and systems for transforming luminal images”, and U.S. Patent No. 11,816,838, titled “Intravascular ultrasound imaging”, which are incorporated by reference as though fully set forth herein.

[0126] Figure 26 is a screen display 2600 showing an image from the live, treatment phase fluoroscopy image stream 550 side-by-side with a stabilized image 2610, according to aspects ofthe present disclosure. In the live image 550, the blood vessel 300 and stent placement catheter 140 both move along with the beating of the heart, whereas in the live, stabilized image 2610, the blood vessel 300 and stent placement catheter 140 do not move along with the beating of the heart. The screen display 2600 may for example provide context and situational awareness to the clinician as the catheter 140 is advanced through the vessel 300 toward the landing zones 344, 346.

[0127] Figure 27 is a screen display 2700 showing an image from the live, treatment phase fluoroscopy image stream 550 side-by-side with a stabilized, zoomed image 2710, according to aspects of the present disclosure. In the live image 550, the blood vessel 300 and stent placement catheter 140 both move along with the beating of the heart. In the live, stabilized, zoomed image 2710, the blood vessel 300 and stent placement catheter 140 do not move along with the beating of the heart, and the view is focused on the landing zones 344, 346, such that the radiopaque markers 148 can be clearly seen in relation to the landing zones. The screen display 2700 may for example provide context and situational awareness to the clinician as the catheter 140 is advanced through the vessel 300 toward the landing zones 344, 346.

[0128] Figure 28 is an image from the live, treatment phase fluoroscopy image stream 2900, according to aspects of the present disclosure. Visible are a treatment catheter 152 with a radiopaque marking 158 at its distal end. In general, the treatment catheter 152 my be any treatment device, including but not limited to a mechanical atherectomy, laser atherectomy, or balloon angioplasty device, e.g., for treating a calcified lesion in a blood vessel. A calcium start indicator 2910 marks the proximal end of a treatment zone, and may for example represent the first location where the amount of calcium exceeds a certain threshold such as 180 degrees of coverage within the vessel (although other values both larger and smaller may be used instead or in addition). Similarly, a calcium end indicator 2920 marks the distal end of a treatment zone, and may for example represent the last location where the amount of calcium exceeds the threshold. The calcium start marker 2910 and calcium end marker 2920 are co-registered from the data points (e.g., stored metrics from the data structure of Figure 7), and may for example provide guidance for the clinician to perform laser atherectomy within this region, and / or to change the laser atherectomy settings within this region, such as fluence (mJ / mm2) or rate (pulses / sec). For example, locations with 180 degrees or more of calcium may require higherintensity and thus an increase in fluence or rate as compared with other locations (e.g., locations with less than 180 degrees of calcium).

[0129] Examples of laser atherectomy catheters may be found for example in U.S. Patent No. 10,799,293, titled “Laser ablation catheter”, U.S. Patent No. 10,864,042, titled “Optical assembly for laser generator”, U.S. Patent No. 10,327,846, titled “Methods for treating vascular stenoses including laser atherectomy and drug delivery via drug-coated balloons”, and U.S. Publication No. 2023 / 0190229, titled “Control of laser atherectomy by co-registered intravascular imaging”, which are incorporated by reference as though fully set forth herein.

[0130] Figure 29 is a schematic, diagrammatic representation of a catheter lab session 2000, according to aspects of the present disclosure. Figure 29 includes steps associated with two phases: a pre-stent placement phase or planning phase 2902, and a stent placement phase or treatment phase 2904. Physiology data associated with pre-stent placement 2902 may facilitate stent placement planning, including location and mapping out the diseased regions of a blood vessel, e.g., 350 as described in Figure 3. Physiology data associated with stent placement 2904 may allow a physician or other medical professional to track, in real-time, the path of the stent as it traverses the vasculature towards the targeted diseased region, and also to evaluate the success of the stent placement procedure in real time. In each of the two phases, pre-stent or planning 502 and stent placement or treatment 2904, X-ray imaging, with or without contrast, may be utilized. In the pre-stent phase 2902, intravascular physiology data may be utilized.

[0131] The physiology data may for example be obtained by a pressure sensor and / or flow sensor being pulled back along a length of the blood vessel, and may include the raw pressure or flow values, as well as ratios calculated by the processor circuit 160 (see Fig. IB). The ratios may include hyperemic ratios such as fractional flow reserve (FFR), non-hyperemic pressure ratios such as instantaneous wave free ratio (iFR), as well as other ratios known in the art, including but not limited to RFR, DRF, dPR, and / or Pd / Pa. Thus, the physiology pullback data points 2910 may include pressure values, flow values, pressure ratio values, or flow ratio values for each blood vessel location along the pullback. Similarly, the longitudinal view 2920 may be or may include a plot of a raw pressure or flow value and / or a pressure or flow ratio vs. position along the blood vessel.

[0132] The pre-stent phase or planning phase 2902 may include X-ray imaging 508, intravascular physiology pullback 2910, and single-frame x-ray imaging 515 (see Figure 40,below). X-ray imaging 508 may include multiple X-ray frames without the use of contrast agent to facilitate real-time imaging, i.e., fluoroscopy. In X-ray imaging 508, an intravascular imaging catheter present in the vasculature is visible. Intravascular physiology pullback 2910 may include a pullback procedure whereby data for multiple intravascular locations may be acquired. Single frame X-ray imaging 515 may include a single X-ray frame with contrast, i.e., an angiogram, wherein the vasculature is visible.

[0133] From the images generated during the pre-stent phase 2902, a co-registration 2980 between the intravascular physiology pullback 2910 and the single-frame X-ray imaging (e.g., an angiogram) 515 may be performed. For example, each data point of the intravascular physiology pullback may be associated with a point along the blood vessel as depicted in the angiogram 515.

[0134] The intravascular physiology pullback 2910 can also provide a longitudinal view 2920, such as a plot, which allows a clinician to see, at a glance, physiological features of the blood vessel along the imaged length. The intravascular physiology pullback 2910 can also provide a treatment plan 2940. In the case of a stenting procedure, the treatment plan 2940 may for example include the target location, proximal stent landing zone, and distal stent landing zone, which (depending on the implementation) may be calculated automatically by the system, may be calculated or recalculated at least in part based on inputs from the user, or may be manually selected by the user. In the case of a laser atherectomy treatment or other treatment, the treatment plan 2940 may include the target location, proximal border of the atherectomy treatment zone, and distal border of the atherectomy treatment zone.

[0135] The stent placement phase or treatment phase 2904 may include real-time X-ray imaging 550. Real-time x-ray imaging 550 may done without a contrast agent. Real-time X-ray imaging 550, also referred to as fluoroscopy, may allow a physician or other medical profession to view the progress of a stent or atherectomy treatment device through a blood vessel as it is delivered to a target location.

[0136] During the treatment phase or stent placement phase 2904, a co-registration 2990 between the intravascular pullback physiology data points 2910 and the live fluoroscopy imaging 550 may be performed. For example, each data point of the intravascular physiology pullback 2910 may be associated with a point along the blood vessel as depicted in the fluoroscopy images 550.

[0137] As described herein, various features of the vasculature, user-provided markers, and plaque may be used to align the pre-stent pullback 2910 with the X-ray imaging 515, 550. In some instances, this has the benefit of reducing the amount of X-ray imaging required and thus the radiation exposure of the patient subject to the imaging procedure. One of the challenges with co-registering with the live fluoroscopic image stream 550 is the movement of the blood vessel due to beating of the heart, as described below.

[0138] Figure 30 is an image from the live, treatment phase fluoroscopy image stream 550, co-registered with physiology data, according to aspects of the present disclosure. Visible ate the stent delivery catheter 140, stent 142, balloon 146, radiopaque markers 148, co-registered distal landing zone 344 and proximal landing zone 346, a co-registered stent length 3020 (e.g., the distance between the proximal and distal landing zones), and co-registered physiology data points 3010. In the example shown in Figure 30, each location along the blood vessel 300 is represented by a number of dots, where each dot represents a change of the iFR value at that location of 0.01. Locations along the blood vessel 300 that are proximal of the proximal landing zone 346 or distal of the distal landing zone 344 are healthy tissue, and are thus represented by zero dots or one dot, whereas locations along the blood vessel 300 that are between the proximal landing zone 346 and the distal landing zone 344 are portions of the lesion that is being treated, and are thus represented by multiple dots, indicating significant drops in iFR that are associated with reduced diameter of the vessel at these locations.

[0139] Figure 31 is an image from the live, treatment phase fluoroscopy image stream 550, co-registered with physiology data, according to aspects of the present disclosure. Visible ate the stent delivery catheter 140, stent 142, balloon 146, radiopaque markers 148, co-registered distal landing zone 344 and proximal landing zone 346, a co-registered stent length 3020 (e.g., the distance between the proximal and distal landing zones), and co-registered physiology data points 3010. Figure 31 is similar to Figure 30 except that the stent delivery catheter 140 has been advanced until the radiopaque markers 148 align with the proximal landing zone 346 and distal landing zone 344.

[0140] Figure 32 is a screen display 3200 of an example co-registration system, according to aspects of the present disclosure. The screen display 3200 includes an image from the live, treatment phase fluoroscopy image stream 550, in which the blood vessel 300, stent placement catheter 140, stent 142, balloon 146, and radiopaque markings 148 are visible. Also visible are aproximal metric report 3210 and distal metric report 3220, showing the iFR values at the proximal and distal radiopaque markings 148, respectively. Other values besides iFR may be shown instead or in addition.

[0141] The screen display 3200 includes a longitudinal view 2920, which may for example a graph or plot of iFR 3240 (or another blood vessel metric) vs. distance 3250 along the blood vessel 300. The longitudinal view 2920 shows the the distal landing zone 344, proximal landing zone 346, distance indicator or stent size indicator 3230, and co-registered radiopaque markers 148. The longitudinal view 2920 makes it possible for the clinician to see, at a glance, the physiological parameters of the blood vessel 300 at different locations along its length, such that a plaque or stenosis 330 is clearly visible (e.g., as locations where the iFR has a significant nonzero slope).

[0142] The present disclosure provides for displaying the co-registered radiopaque markers on the ILD 520, thus allowing the clinician to clearly visualize the movement of the stent with respect to the stenosis 330 (see Figure 3) and the landing zones 344, 346.

[0143] Figure 33 is a screen display 3200 of an example co-registration system, according to aspects of the present disclosure. The screen display 3200 includes an image from the live, treatment phase fluoroscopy image stream 550, in which the blood vessel 300, stent placement catheter 140, stent 142, balloon 146, and radiopaque markings 148 are visible. Also visible are a proximal metric report 3210 and distal metric report 3220, showing the iFR values at the proximal and distal radiopaque markings 148, respectively. The screen display 3200 includes a longitudinal view 2920 plotting iFR 3240 vs. distance 3250.

[0144] Figure 33 is similar to Figure 32, except that the stent delivery catheter 140 has been advanced until the radiopaque markings 148 are aligned with the landing zones 344, 346. As a result, the landing zones 344, 346 have been highlighted (e.g., brightened, darkened, bolded, turned green, or otherwise).

[0145] Figure 34 is a representation 3400 of a screen display 3200 at two different times, according to aspects of the present disclosure. In the first screen display 3200-1 at a first time, the stent placement catheter 140 is in a first position along the blood vessel 300, and the blood vessel 300 is also in a first position. In the second screen display 2200-2 at a second time, the stent placement catheter 140 is in a different, second position along the blood vessel 300, e.g., because the clinician has advanced it toward the landing zones 344, 346. However, the bloodvessel 300 is also in a different, second position within the screen display 2200-2, because cardiac motion (e.g., the beating of the heart) has induced motion of the blood vessel.

[0146] In the example shown in Figure 34, the co-registered landing zones 344, 346 and physiology data points 3010 move along with the vessel 300. At times, this motion may result in the physiology data points 3010 and / or the landing zones 344, 346 being cut off by the edge of the screen. The clinician may therefore choose to use the separate data co-registration control 3410 and landing zone co-registration control 3420 to enable or disable these co-registered features.

[0147] Figure 35 is a screen display 3500 showing an image from the live, treatment phase fluoroscopy image stream 550 side-by-side with a stabilized, zoomed X-ray image 3510, according to aspects of the present disclosure. In the live image 550, the blood vessel 300 and stent placement catheter 140 both move along with the beating of the heart. In the live, stabilized, zoomed image 2710, the blood vessel 300 and stent placement catheter 140 do not move along with the beating of the heart, and the view is focused on the landing zones 344, 346, such that the radiopaque markers 148 can be clearly seen in relation to the landing zones 344, 346 and the physiology data points 3010. The screen display 3500 may for example provide context and situational awareness to the clinician as the catheter 140 is advanced through the vessel 300 toward the landing zones 344, 346.

[0148] Figure 36 is an angiographic roadmap image 515, according to aspects of the present disclosure. In an example, the angiographic roadmap image is a single X-ray image taken with contrast during the treatment planning phase, showing the vessel 300 along with co-registered treatment plan. In the example shown in Figure 36, the vessel becomes narrower in the distal direction, and the treatment plan includes not only the distal landing zone 344, proximal landing zone 346, and planned stent length 3630, but also a planned stent diameter 3610 at the proximal edge of the stent, and planned stent diameter 3620 at the distal edge of the stent. Having two different planned stent diameters may for example allow the clinician to account for the tapering of the blood vessel, and thus ensure a better placement of the stent across the stenosis (e.g., less risk of malapposition or inadequate stent expansion.

[0149] Figure 37 is a screen display 3700 of an example co-registration system, according to aspects of the present disclosure. The screen display 3700 includes an image from the live fluoroscopic X-ray image stream 550, in which the stent delivery catheter 140, stent 142, balloon146, and radiopaque markers 148 are visible, along with the co-registered distal landing zone 344 and proximal landing zone 346. The screen display 3700 also includes a proximal stent edge expansion report 3710 and a distal stent edge expansion report 3720. In the example shown in Figure 37, the distal stent edge expansion report 3720 shows that the distal edge of the stent has been expanded to a diameter of 3 mm, which is equal to the planned diameter of 3mm. Therefore, the distal stent edge expansion report 3720 has been highlighted (e.g., brightened, darkened, bolded, colored green, or otherwise). However, the proximal stent edge expansion report 3710 shows that the proximal edge of the stent has also been expanded to a diameter of 3 mm, which is less than the planned diameter of 4 mm. Therefore, the proximal stent edge expansion report 3710 has not been highlighted. A clinician may therefore surmise that further expansion of the proximal portion of the stent is necessary or desirable.

[0150] Figure 38 is a screen display 3700 of an example co-registration system, according to aspects of the present disclosure. The screen display 3700 includes an image from the live fluoroscopic X-ray image stream 550, in which the stent delivery catheter 140, stent 142, balloon 146, and radiopaque markers 148 are visible, along with the co-registered distal landing zone 344 and proximal landing zone 346. The screen display 3700 also includes a proximal stent edge expansion report 3710 and a distal stent edge expansion report 3720. In the example shown in Figure 38, the distal stent edge expansion report 3720 shows that the distal edge of the stent has been expanded to a diameter of 3 mm, which is equal to the planned diameter of 3mm.Therefore, the distal stent edge expansion report 3720 has been highlighted (e.g., brightened, darkened, bolded, colored green, or otherwise). Similarly, the proximal stent edge expansion report 3710 shows that the proximal edge of the stent has been expanded to a diameter of 4 mm, which is equal to the planned diameter of 4 mm. Therefore, the proximal stent edge expansion report 3710 has also been highlighted. A clinician may therefore surmise that the stent is properly or sufficiently expanded, and that no further expansion of the stent is necessary or desirable.

[0001] Figure 39 is a stent planning screen display 3900 of an example intravascular imaging system 110, according to aspects of the present disclosure. The screen display 3900 includes a tomographic image 3910 of the blood vessel 300, along with the estimated lumen boundary 310, measurements 39440, and ILD angle indicator 3970. Also visible is a coregistered angiographic X-ray roadmap image 515, that includes a highlighted treatment region3920 of the blood vessel 300 where the stent will be placed, in between the distal landing zone 344 and proximal landing zone 346. Also visible is a longitudinal display 520 of the blood vessel 300, including the frame indicator / direction indicator 3960. The longitudinal display 520 is assembled in the same way from the stack of tomographic images acquired during the pullback. Visible in the longitudinal display 5200 is a side branch 3925, which is a secondary blood vessel branching away from the blood vessel 300, and which may for example be bookmarked by the clinician after the pullback is complete.

[0002] Figure 40 is a is a stent planning screen display 4000 of an example intravascular physiology measurement system 120, according to aspects of the present disclosure. The screen display 4000 includes a co-registered angiographic X-ray roadmap image 515, that includes a highlighted treatment region 4020 of the blood vessel 300 where the stent will be placed, in between the distal landing zone 344 and proximal landing zone 346. Also visible is a longitudinal display graph 2920 relating iFR to distance along the blood vessel 300. The highlighted treatment region 4020 and landing zones 344, 346 are also visible in the longitudinal display graph 2920.

[0003] A system of one or more computers can be configured to perform particular operations or actions by virtue of having software, firmware, hardware, or a combination of them installed on the system that in operation causes or cause the system to perform the actions. One or more computer programs can be configured to perform particular operations or actions by virtue of including instructions that, when executed by data processing apparatus, cause the apparatus to perform the actions.

[0004] One general aspect includes an apparatus that includes a processor configured to: receive a plurality of x-ray images obtained by an x-ray imaging device, where the plurality of x- ray images depicts: a blood vessel of a patient without a contrast medium inside of the blood vessel; and a treatment catheter during movement through the blood vessel, where the treatment catheter is configured to provide a treatment to the blood vessel; retrieve, from a memory in communication with the processor, a treatment plan distinct from an intravascular image; generate a screen display may include: the plurality of x-ray images without the contrast medium displayed successively during the movement of the treatment catheter; and a visual representation of the treatment plan overlaid on the plurality of x-ray images without the contrast medium; and output the screen display to a display in communication with the processor. Otherexamples 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.

[0005] Implementations may include one or more of the following features. In some aspects, the treatment plan may include at least one of a start location or an end location for the treatment along a length of the blood vessel. In some aspects, the visual representation of the treatment plan may include at least one of: a first indicator configured to identify the start location on the blood vessel in the plurality of x-ray images without the contrast medium; or a second indicator configured to identify the end location on the blood vessel in the plurality of x-ray images without the contrast medium. In some aspects, at least one of the first indicator or the second indicator may include a transverse line segment. In some aspects, at least one of the first indicator or the second indicator is configured to move based on cardiac motion such that at least one of the first indicator or the second indicator identifies the start location in each of the plurality of x-ray images without the contrast medium, respectively, while the plurality of x-ray images without the contrast medium is displayed successively during the cardiac motion. In some aspects, the processor circuit is configured to change an appearance of the visual representation of the treatment plan based on the treatment catheter moving into alignment with at least one of the start location or the end location. In some aspects, the appearance of the visual representation of the treatment plan may include a color. In some aspects, the processor circuit is configured to change the appearance of the at least one of the first indicator or the second indicator. In some aspects, the visual representation of the treatment plan may include an alignment indicator separate from at least one of the first indicator or the second indicator, where the processor circuit is configured to change the appearance of the alignment indicator. In some aspects, the start location may include one of a proximal landing zone for a proximal edge of a stent or a distal landing zone for a distal edge of the stent, where the end location may include the other of the proximal landing zone or the distal landing zone. In some aspects, the treatment catheter may include a stent delivery catheter may include the stent, where the treatment may include deployment of the stent. In some aspects, the start location may include a beginning of a region of the blood vessel, where the end location may include an end of the region of the blood vessel, and where the region of the blood vessel is defined by calcium may include an angle greater than or equal to a threshold angle. In some aspects, the treatment catheter may includelaser atherectomy catheter, where the treatment may include delivery of laser pulses to the region of the blood vessel by the laser atherectomy catheter. In some aspects, the intravascular data may include intravascular ultrasound (IVUS) images or optical coherence tomography (OCT) images. In some aspects, the visual representation of the treatment plan may include at least one of a graphic, text, or a numerical value associated with the IVUS images or the OCT images such that the visual representation is separate from the IVYS images and the OCT images themselves. In some aspects, the intravascular data may include pressure data or flow data. In some aspects, the visual representation of the treatment plan may include at least one of a graphic, text, or a numerical value associated with the pressure data or the flow data. In some aspects, the visual representation of the treatment plan is configured to change based on a current position of the treatment catheter during the movement of the treatment catheter. In some aspects, the treatment plan is based on intravascular data that was previously: acquired by an intravascular catheter or guidewire from the blood vessel; and co-registered to an x-ray image with the contrast medium inside the blood vessel. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer-accessible medium.

[0006] One general aspect includes an apparatus. The apparatus includes a processor configured to: receive a plurality of x-ray images obtained by an x-ray imaging device, where the plurality of x-ray images depicts: a blood vessel of a patient without a contrast medium inside of the blood vessel; and a treatment catheter during movement through the blood vessel, where the treatment catheter is configured to provide a treatment to the blood vessel; retrieve, from a memory in communication with the processor, a longitudinal view associated with the blood vessel; generate a screen display may include: the plurality of x-ray images without the contrast medium displayed successively during the movement of the treatment catheter; and the longitudinal view; and a current position of the treatment catheter overlaid on the longitudinal view during the movement of the treatment catheter, output the screen display to a display in communication with the processor. Other examples 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.

[0007] Implementations may include one or more of the following features. In some aspects, the screen display may include at least one of a start location or an end location for the treatment along a length of the longitudinal view. In some aspects, the intravascular data may includeintravascular ultrasound (IVUS) images or optical coherence tomography (OCT) images, where the longitudinal view may include a cross-sectional view of the blood vessel based on the IVUS images or the oct images. In some aspects, the intravascular data may include pressure data or flow data, where the longitudinal view may include a plot based on the pressure data or the flow data. In some aspects, the longitudinal view is based on intravascular data that was previously: acquired by an intravascular catheter or guidewire from the blood vessel and co-registered to an x-ray image with the contrast medium inside the blood vessel. Implementations of the described techniques may include hardware, a method or process, or computer software on a computer- accessible medium.

[0151] 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.

[0152] 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 planning system. Connection references, e.g., attached, coupled, connected, joined, or “in communication with” are to be construed broadly and may include intermediate members between a collection of elements and relative movement between elements unless otherwise indicated. As such, connection references do not necessarily imply that two elements are directly connected and in fixed relation to each other. 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.

[0153] The above specification, examples and data provide a complete description of the structure and use of exemplary aspects of the stent placement planning 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 skilledin the art could make numerous alterations to the disclosed aspects without departing from the spirit or scope of the claimed subject matter.

[0154] 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

CLAIMSWhat is claimed is:

1. An apparatus, comprising: a processor configured to: receive a plurality of x-ray images obtained by an x-ray imaging device, wherein the plurality of x-ray images depicts: a blood vessel of a patient without a contrast medium inside of the blood vessel; and a treatment catheter during movement through the blood vessel, wherein the treatment catheter is configured to provide a treatment to the blood vessel; retrieve, from a memory in communication with the processor, a treatment plan distinct from an intravascular image; generate a screen display comprising: the plurality of x-ray images without the contrast medium displayed successively during the movement of the treatment catheter; and a visual representation of the treatment plan overlaid on the plurality of x- ray images without the contrast medium; and output the screen display to a display in communication with the processor.

2. The apparatus of claim 1 , wherein the treatment plan comprises at least one of a start location or an end location for the treatment along a length of the blood vessel.

3. The apparatus of claim 2, wherein the visual representation of the treatment plan comprises at least one of: a first indicator configured to identify the start location on the blood vessel in the plurality of x-ray images without the contrast medium; or a second indicator configured to identify the end location on the blood vessel in the plurality of x-ray images without the contrast medium.

4. The apparatus of claim 3, wherein at least one of the first indicator or the second indicator comprises a transverse line segment.

5. The apparatus of claim 3, wherein at least one of the first indicator or the second indicator is configured to move based on cardiac motion such that at least one of the first indicator or the second indicator identifies the start location in each of the plurality of x-ray images without the contrast medium, respectively, while the plurality of x-ray images without the contrast medium is displayed successively during the cardiac motion.

6. The apparatus of claim 2, wherein the start location comprises one of a proximal landing zone for a proximal edge of a stent or a distal landing zone for a distal edge of the stent, wherein the end location comprises the other of the proximal landing zone or the distal landing zone.

7. The apparatus of claim 6, wherein the treatment catheter comprises a stent delivery catheter comprising the stent, wherein the treatment comprises deployment of the stent.

8. The apparatus of claim 2, wherein the start location comprises a beginning of a region of the blood vessel, wherein the end location comprises an end of the region of the blood vessel, and wherein the region of the blood vessel is defined by calcium comprising an angle greater than or equal to a threshold angle.

9. The apparatus of claim 8, wherein the treatment catheter comprises laser atherectomy catheter, wherein the treatment comprises delivery of laser pulses to the region of the blood vessel by the laser atherectomy catheter.

10. The apparatus of claim 3, wherein the processor is configured to change an appearance of the visual representation of the treatment plan based on the treatment catheter moving into alignment with at least one of the start location or the end location.

11. The apparatus of claim 10, wherein the appearance of the visual representation of the treatment plan comprises a color.

12. The apparatus of claim 11, wherein the processor is configured to change the appearance of the at least one of the first indicator or the second indicator.

13. The apparatus of claim 11, wherein the visual representation of the treatment plan comprises an alignment indicator separate from at least one of the first indicator or the second indicator, wherein the processor is configured to change the appearance of the alignment indicator.

14. The apparatus of claim 1, wherein the intravascular data comprises intravascular ultrasound (IVUS) images or optical coherence tomography (OCT) images.

15. The apparatus of claim 14, wherein the visual representation of the treatment plan comprises at least one of a graphic, text, or a numerical value associated with the IVUS images or the OCT images such that the visual representation is separate from the IVUS images and the OCT images themselves.

16. The apparatus of claim 1, wherein the intravascular data comprises pressure data or flow data.

17. The apparatus of claim 16, wherein the visual representation of the treatment plan comprises at least one of a graphic, text, or a numerical value associated with the pressure data or the flow data.

18. The apparatus of claim 16, wherein the visual representation of the treatment plan is configured to change based on a current position of the treatment catheter during the movement of the treatment catheter.

19. The apparatus of claim 1, wherein the treatment plan is based on intravascular data that was previously: acquired by an intravascular catheter or guidewire from the blood vessel; and co-registered to an x-ray image with the contrast medium inside the blood vessel.

20. An apparatus, comprising: a processor configured to: receive a plurality of x-ray images obtained by an x-ray imaging device, wherein the plurality of x-ray images depicts: a blood vessel of a patient without a contrast medium inside of the blood vessel; and a treatment catheter during movement through the blood vessel, wherein the treatment catheter is configured to provide a treatment to the blood vessel; retrieve, from a memory in communication with the processor, a longitudinal view associated with the blood vessel; generate a screen display comprising: the plurality of x-ray images without the contrast medium displayed successively during the movement of the treatment catheter; and the longitudinal view; and a current position of the treatment catheter overlaid on the longitudinal view during the movement of the treatment catheter, output the screen display to a display in communication with the processor.

21. The apparatus of claim 20, wherein the screen display comprises at least one of a start location or an end location for the treatment along a length of the longitudinal view.

22. The apparatus of claim 20,wherein the intravascular data comprises intravascular ultrasound (IVUS) images or optical coherence tomography (OCT) images, wherein the longitudinal view comprises a cross-sectional view of the blood vessel based on the IVUS images or the OCT images.

23. The apparatus of claim 20, wherein the intravascular data comprises pressure data or flow data, wherein the longitudinal view comprises a plot based on the pressure data or the flow data.

24. The apparatus of claim 20, wherein the longitudinal view is based on intravascular data that was previously: acquired by an intravascular catheter or guidewire from the blood vessel; and co-registered to an x-ray image with the contrast medium inside the blood vessel.

Images