Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B6/00—Apparatus or devices for radiation diagnosis; Apparatus or devices for radiation diagnosis combined with radiation therapy equipment
  • A61B6/12—Arrangements for detecting or locating foreign bodies
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/08—Clinical applications
  • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/08—Clinical applications
  • A61B8/0891—Clinical applications for diagnosis of blood vessels
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/46—Ultrasonic, sonic or infrasonic diagnostic devices with special arrangements for interfacing with the operator or the patient
  • A61B8/461—Displaying means of special interest
  • A61B8/463—Displaying means of special interest characterised by displaying multiple images or images and diagnostic data on one display
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/52—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves
  • A61B8/5215—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data
  • A61B8/5238—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for combining image data of patient, e.g. merging several images from different acquisition modes into one image
  • A61B8/5261—Devices using data or image processing specially adapted for diagnosis using ultrasonic, sonic or infrasonic waves involving processing of medical diagnostic data for combining image data of patient, e.g. merging several images from different acquisition modes into one image combining images from different diagnostic modalities, e.g. ultrasound and X-ray

Definitions

• Fig. 1 is a schematic diagram of an intraluminal imaging and x-ray system, according to aspects of the present disclosure.
• the extraluminal imaging system 151 obtains medical data about the patient’s body while the extraluminal imaging device 152 is positioned outside the patient’s body.
• the extraluminal imaging system 151 can control extraluminal imaging device 152 to obtain extraluminal images of the inside of the patient’s body while the extraluminal imaging device 152 is outside the patient’ s body.
• This communication includes the steps of: (1) providing commands to integrated circuit controller chip(s) included in the scanner assembly 110 to select the particular transducer array element(s), or acoustic element(s), to be used for transmit and receive, (2) providing the transmit trigger signals to the integrated circuit controller chip(s) included in the scanner assembly 110 to activate the transmitter circuitry to generate an electrical pulse to excite the selected transducer array element(s), and/or (3) accepting amplified echo signals received from the selected transducer array element(s) via amplifiers included on the integrated circuit controller chip(s) of the scanner assembly 110.
• the communication interface 140 performs preliminary processing of the echo data prior to relaying the data to the processor 134.
• the communication interface 140 performs amplification, filtering, and/or aggregating of the data. In an embodiment, the communication interface 140 also supplies high- and low-voltage DC power to support operation of the device 102 including circuitry within the scanner assembly 110.
• the IVUS device includes some features similar to traditional solid-state IVUS catheters, such as the EagleEye® catheter, Visions PV .014P RX catheter, Visions PV .018 catheter, Visions PV .035, and Pioneer Plus catheter, each of which are available from Koninklijke Philips N.V., and those disclosed in U.S. Patent No. 7,846,101 hereby incorporated by reference in its entirety.
• the IVUS device may include some features similar to rotational IVUS catheter, such as the Revolution® 45 MHz rotational IVUS imaging catheter or the Refinity® short-tip rotational IVUS catheter, each of which are available from Koninklijke Philips N.V.
• the intraluminal imaging system 101 may include a system of any suitable imaging modalities.
• the intraluminal imaging device 102 may acquire intravascular images of any suitable imaging modality, including optical coherence tomography (OCT) and intravascular photoacoustic (IVPA).
• OCT optical coherence tomography
• IVPA intravascular photoacoustic
• the intraluminal device 102 is a flow sensing device (e.g., flowsensing guidewire) that obtains intraluminal (e.g., intravascular) flow data
• the intraluminal system 101 is an intravascular flow sensing system that determines flow-related values based on the pressure data, such as coronary flow reserve (CFR), flow velocity, flow volume, etc.
• CFR coronary flow reserve
• the x-ray source 160 may include an x-ray tube adapted to generate x-rays. Some aspects of the x-ray source 160 may include one or more vacuum tubes including a cathode in connection with a negative lead of a high-voltage power source and an anode in connection with a positive lead of the same power source.
• the cathode of the x-ray source 160 may additionally include a filament.
• the filament may be of any suitable type or constructed of any suitable material, including tungsten or rhenium tungsten, and may be positioned within a recessed region of the cathode.
• One function of the cathode may be to expel electrons from the high voltage power source and focus them into a well-defined beam aimed at the anode.
• the x-ray source 160 may include a radiation object focus which influences the visibility of an image.
• the radiation object focus may be selected by a user of the system 100 or by a manufacture of the system 100 based on characteristics such as blurring, visibility, heat-dissipating capacity, or other characteristics.
• an operator or user of the system 100 may switch between different provided radiation object foci in a point-of-care setting.
• the detector 170 may be configured to acquire x-ray images and may include the input screen 174.
• the input screen 174 may include one or more intensifying screens configured to absorb x-ray energy and convert the energy to light. The light may in turn expose a film.
• the input screen 174 may be used to convert x-ray energy to light in embodiments in which the film may be more sensitive to light than x-radiation. Different types of intensifying screens within the image intensifier may be selected depending on the region of a patient to be imaged, requirements for image detail and/or patient exposure, or any other factors.
• Intensifying screens may be constructed of any suitable materials, including barium lead sulfate, barium strontium sulfate, barium fluorochloride, yttrium oxysulfide, or any other suitable material.
• the input screen 374 may be a fluorescent screen or a film positioned directly adjacent to a fluorescent screen. In some embodiments, the input screen 374 may also include a protective screen to shield circuitry or components within the detector 370 from the surrounding environment.
• the x-ray detector 170 may include a flat panel detector (FPD). The detector 170 may be an indirect conversion FPD or a direct conversion FPD. The detector 170 may also include charge-coupled devices (CCDs).
• the x-ray detector 370 may additionally be referred to as an x-ray sensor.
• the object 180 may be any suitable object to be imaged.
• the object may be the anatomy of a patient. More specifically, the anatomy to be imaged may include chest, abdomen, the pelvic region, neck, legs, head, feet, a region with cardiac vasculature, or a region containing the peripheral vasculature of a patient and may include various anatomical structures such as, but not limited to, organs, tissue, blood vessels and blood, gases, or any other anatomical structures or objects. In other embodiments, the object may be or include man-made structures.
• the x-ray imaging system 151 may be configured to obtain x- ray images without contrast.
• the x-ray imaging system 151 may be configured to obtain x-ray images with contrast (e.g., angiogram or venogram).
• a contrast agent or x-ray dye may be introduced to a patient’s anatomy before imaging.
• the contrast agent may also be referred to as a radiocontrast agent, contrast material, contrast dye, or contrast media.
• the contrast dye may be of any suitable material, chemical, or compound and may be a liquid, powder, paste, tablet, or of any other suitable form.
• the contrast dye may be iodine -based compounds, barium sulfate compounds, gadolinium-based compounds, or any other suitable compounds.
• the contrast agent may be used to enhance the visibility of internal fluids or structures within a patient’ s anatomy.
• the contrast agent may absorb external x-rays, resulting in decreased exposure on the x-ray detector 170.
• the extraluminal imaging system 151 could be any suitable extraluminal imaging device, such as computed tomography (CT) or magnetic resonance imaging (MRI).
• CT computed tomography
• MRI magnetic resonance imaging
• the communication interface 140 facilitates communication of signals between the control system 130 and the x-ray device 152.
• This communication includes providing control commands to the x-ray source 160 and/or the x-ray detector 170 of the x-ray device 152 and receiving data from the x-ray device 152.
• the communication interface 140 performs preliminary processing of the x-ray data prior to relaying the data to the processor 134.
• the communication interface 140 may perform amplification, filtering, and/or aggregating of the data.
• the communication interface 140 also supplies high- and low-voltage DC power to support operation of the device 152 including circuitry within the device.
• the processor 134 receives the x-ray data from the x-ray device 152 by way of the communication interface 140 and processes the data to reconstruct an image of the anatomy being imaged.
• the processor 134 outputs image data such that an image is displayed on the display 132.
• the particular areas of interest to be imaged may be one or more blood vessels or other section or part of the human vasculature.
• the contrast agent may identify fluid filled structures, both natural and/or man-made, such as arteries or veins of a patient’ s vascular system, including cardiac vasculature, peripheral vasculature, neural vasculature, renal vasculature, and/or any other suitable lumen inside the body.
• the x-ray device 152 may be used to examine any number of anatomical locations and tissue types, including without limitation all the organs, fluids, or other structures or parts of an anatomy previously mentioned.
• the x-ray device 152 may be used to examine man-made structures such as any of the previously mentioned structures.
• the processor 134 may be configured to receive an x-ray image that was stored by the x-ray imaging device 152 during a clinical procedure.
• the images may be further enhanced by other information such as patient history, patient record, IVUS imaging, pre-operative ultrasound imaging, pre-operative CT, or any other suitable data.
• Fig. 2 is a diagrammatic top view of a portion of a flexible assembly 110, according to aspects of the present disclosure.
• the flexible assembly 110 includes a transducer array 124 formed in a transducer region 204 and transducer control logic dies 206 (including dies 206A and 206B) formed in a control region 208, with a transition region 210 disposed therebetween.
• the transducer array 124 includes an array of ultrasound transducer elements 212.
• the transducer control logic dies 206 are mounted on a flexible substrate 214 into which the transducer elements 212 have been previously integrated.
• the flexible substrate 214 is shown in a flat configuration in Fig. 2. Though six control logic dies 206 are shown in Fig. 2, any number of control logic dies 206 may be used. For example, one, two, three, four, five, six, seven, eight, nine, ten, or more control logic dies 206 may be used.
• the flexible substrate 214 on which the transducer control logic dies 206 and the transducer elements 212 are mounted, provides structural support and interconnects for electrical coupling.
• the flexible substrate 214 may be constructed to include a film layer of a flexible polyimide material such as KAPTONTM (trademark of DuPont).
• a flexible polyimide material such as KAPTONTM (trademark of DuPont).
• suitable materials include polyester films, polyimide films, polyethylene napthalate films, or polyetherimide films, liquid crystal polymer, other flexible printed semiconductor substrates as well as products such as Upilex® (registered trademark of Ube Industries) and TEFLON® (registered trademark of E.I. du Pont).
• Upilex® registered trademark of Ube Industries
• TEFLON® registered trademark of E.I. du Pont
• the flexible substrate 214 is configured to be wrapped around a support member 230 (Fig. 3) in some instances. Therefore, the thickness of the film layer of the flexible substrate 214 is generally related to the degree of curvature in the final assembled flexible assembly 110. In some embodiments, the film layer is between 5 • m and 100 • m, with some particular embodiments being between 5 • m and 25.1 • m, e.g., 6 • m.
• the set of transducer control logic dies 206 is a non-limiting example of a control circuit.
• the transducer region 204 is disposed at a distal portion 221 of the flexible substrate 214.
• the control region 208 is disposed at a proximal portion 222 of the flexible substrate 214.
• the transition region 210 is disposed between the control region 208 and the transducer region 204.
• Dimensions of the transducer region 204, the control region 208, and the transition region 210 can vary in different embodiments.
• the lengths 225, 227, 229 can be substantially similar or, the length 227 of the transition region 210 may be less than lengths 225 and 229, the length 227 of the transition region 210 can be greater than lengths 225, 229 of the transducer region and controller region, respectively.
• the control logic dies 206 are not necessarily homogenous.
• a single controller is designated a master control logic die 206A and contains the communication interface for cable 112, between a processing system, e.g., processing system 106, and the flexible assembly 110.
• the master control circuit may include control logic that decodes control signals received over the cable 112, transmits control responses over the cable 112, amplifies echo signals, and/or transmits the echo signals over the cable 112.
• the remaining controllers are slave controllers 206B.
• the slave controllers 206B may include control logic that drives a plurality of transducer elements 512 positioned on a transducer element 212 to emit an ultrasonic signal and selects a transducer element 212 to receive an echo.
• the master controller 206A does not directly control any transducer elements 212.
• the master controller 206A drives the same number of transducer elements 212 as the slave controllers 206B or drives a reduced set of transducer elements 212 as compared to the slave controllers 206B.
• a single master controller 206A and eight slave controllers 206B are provided with eight transducers assigned to each slave controller 206B.
• the flexible substrate 214 includes conductive traces 216 formed in the film layer that carry signals between the control logic dies 206 and the transducer elements 212.
• the conductive traces 216 providing communication between the control logic dies 206 and the transducer elements 212 extend along the flexible substrate 214 within the transition region 210.
• the conductive traces 216 can also facilitate electrical communication between the master controller 206A and the slave controllers 206B.
• the conductive traces 216 can also provide a set of conductive pads that contact the conductors 218 of cable 112 when the conductors 218 of the cable 112 are mechanically and electrically coupled to the flexible substrate 214.
• Suitable materials for the conductive traces 216 include copper, gold, aluminum, silver, tantalum, nickel, and tin, and may be deposited on the flexible substrate 214 by processes such as sputtering, plating, and etching.
• the flexible substrate 214 includes a chromium adhesion layer. The width and thickness of the conductive traces 216 are selected to provide proper conductivity and resilience when the flexible substrate 214 is rolled.
• an exemplary range for the thickness of a conductive trace 216 and/or conductive pad is between 1-5 • m.
• 5 • m conductive traces 216 are separated by 5 • m of space.
• the width of a conductive trace 216 on the flexible substrate may be further determined by the width of the conductor 218 to be coupled to the trace or pad.
• the flexible substrate 214 can include a conductor interface 220 in some embodiments.
• the conductor interface 220 can be in a location of the flexible substrate 214 where the conductors 218 of the cable 112 are coupled to the flexible substrate 214.
• the bare conductors of the cable 112 are electrically coupled to the flexible substrate 214 at the conductor interface 220.
• the conductor interface 220 can be tab extending from the main body of flexible substrate 214.
• the main body of the flexible substrate 214 can refer collectively to the transducer region 204, controller region 208, and the transition region 210.
• the conductor interface 220 extends from the proximal portion 222 of the flexible substrate 214.
• the conductor interface 220 is positioned at other parts of the flexible substrate 214, such as the distal portion 221, or the flexible substrate 214 may lack the conductor interface 220.
• the substrate forming the conductor interface 220 is made of the same material(s) and/or is similarly flexible as the flexible substrate 214. In other embodiments, the conductor interface 220 is made of different materials and/or is comparatively more rigid than the flexible substrate 214.
• the conductor interface 220 can be made of a plastic, thermoplastic, polymer, hard polymer, etc., including polyoxymethylene (e.g., DELRIN®), polyether ether ketone (PEEK), nylon, Liquid Crystal Polymer (LCP), and/or other suitable materials.
• polyoxymethylene e.g., DELRIN®
• PEEK polyether ether ketone
• nylon e.g., nylon
• LCP Liquid Crystal Polymer
• Fig. 3 illustrates a perspective view of the scanner assembly 110 in a rolled configuration.
• the flexible substrate 214 is transitioned from a flat configuration (Fig. 2) to a rolled or more cylindrical configuration (Fig. 3).
• techniques are utilized as disclosed in one or more of U.S. Patent No. 6,776,763, titled “ULTRASONIC TRANSDUCER ARRAY AND METHOD OF MANUFACTURING THE SAME” and U.S. Patent No. 7,226,417, titled “HIGH RESOLUTION INTRAVASCULAR ULTRASOUND SENSING ASSEMBLY HAVING A FLEXIBLE SUBSTRATE,” each of which is hereby incorporated by reference in its entirety.
• transducer elements 212 may be piezoelectric transducers, single crystal transducer, or PZT (lead zirconate titanate) transducers.
• the transducer elements of transducer array 124 may be flexural transducers, piezoelectric micromachined ultrasonic transducers (PMUTs), capacitive micromachined ultrasonic transducers (CMUTs), or any other suitable type of transducer element.
• transducer elements 212 may comprise an elongate semiconductor material or other suitable material that allows micromachining or similar methods of disposing extremely small elements or circuitry on a substrate.
• the transducer elements 212 and the controllers 206 can be positioned in an annular configuration, such as a circular configuration or in a polygon configuration, around a longitudinal axis 250 of a support member 230. It is understood that the longitudinal axis 250 of the support member 230 may also be referred to as the longitudinal axis of the scanner assembly 110, the flexible elongate member 121, or the device 102.
• a cross-sectional profile of the imaging assembly 110 at the transducer elements 212 and/or the controllers 206 can be a circle or a polygon.
• any suitable annular polygon shape can be implemented, such as one based on the number of controllers or transducers, flexibility of the controllers or transducers, etc. Some examples may include a pentagon, hexagon, heptagon, octagon, nonagon, decagon, etc.
• the transducer controllers 206 may be used for controlling the ultrasound transducers 512 of transducer elements 212 to obtain imaging data associated with the vessel 120.
• the support member 230 can be referenced as a unibody in some instances.
• the support member 230 can be composed of a metallic material, such as stainless steel, or a non- metallic material, such as a plastic or polymer as described in U.S. Provisional Application No. 61/985,220, “Pre-Doped Solid Substrate for Intravascular Devices,” filed April 28, 2014, the entirety of which is hereby incorporated by reference herein.
• support member 230 may be composed of 303 stainless steel.
• the support member 230 can be a ferrule having a distal flange or portion 232 and a proximal flange or portion 234.
• the support member 230 can be tubular in shape and define a lumen 236 extending longitudinally therethrough.
• the lumen 236 can be sized and shaped to receive the guide wire 118.
• the support member 230 can be manufactured using any suitable process.
• the support member 230 can be machined and/or electrochemically machined or laser milled, such as by removing material from a blank to shape the support member 230, or molded, such as by an injection molding process or a micro injection molding process.
• Fig. 4 shown therein is a diagrammatic cross-sectional side view of a distal portion of the intraluminal imaging device 102, including the flexible substrate 214 and the support member 230, according to aspects of the present disclosure.
• the lumen 236 may be connected with the entry/exit port 116 and is sized and shaped to receive the guide wire 118 (Fig. 1).
• the support member 230 may be integrally formed as a unitary structure, while in other embodiments the support member 230 may be formed of different components, such as a ferrule and stands 242, 243, and 244, that are fixedly coupled to one another.
• the support member 230 and/or one or more components thereof may be completely integrated with inner member 256.
• the inner member 256 and the support member 230 may be joined as one, e.g., in the case of a polymer support member.
• Stands 242, 243, and 244 that extend vertically are provided at the distal, central, and proximal portions respectively, of the support member 230.
• the stands 242, 243, and 244 elevate and support the distal, central, and proximal portions of the flexible substrate 214.
• portions of the flexible substrate 214 such as the transducer portion 204 (or transducer region 204), can be spaced from a central body portion of the support member 230 extending between the stands 242, 243, and 244.
• the stands 242, 243, 244 can have the same outer diameter or different outer diameters.
• the distal stand 242 can have a larger or smaller outer diameter than the central stand 243 and/or proximal stand 244 and can also have special features for rotational alignment as well as control chip placement and connection.
• the cavity between the transducer array 212 and the surface of the support member 230 may be filled with an acoustic backing material 246.
• the liquid backing material 246 can be introduced between the flexible substrate 214 and the support member 230 via passageway 235 in the stand 242, or through additional recesses as will be discussed in more detail hereafter.
• the backing material 246 may serve to attenuate ultrasound energy emitted by the transducer array 212 that propagates in the undesired, inward direction.
• the cavity between the circuit controller chips 206 and the surface of the support member 230 may be filled with an underfill material 247.
• the underfill material 247 may be an adhesive material (e.g. an epoxy) which provides structural support for the circuit controller chips 206 and/or the flexible substrate 214.
• the underfill 247 may additionally be any suitable material.
• the central body portion of the support member can include recesses allowing fluid communication between the lumen of the unibody and the cavities between the flexible substrate 214 and the support member 230.
• Acoustic backing material 246 and/or underfill material 247 can be introduced via the cavities (during an assembly process, prior to the inner member 256 extending through the lumen of the unibody.
• suction can be applied via the passageways 235 of one of the stands 242, 244, or to any other suitable recess while the liquid backing material 246 is fed between the flexible substrate 214 and the support member 230 via the passageways 235 of the other of the stands
• the backing material can be cured to allow it to solidify and set.
• the support member 230 includes more than three stands 242,
• the support member 230 can have an increased diameter distal portion 262 and/or increased diameter proximal portion 264 that is sized and shaped to elevate and support the distal and/or proximal portions of the flexible substrate 214.
• the support member 230 can be substantially cylindrical in some embodiments. Other shapes of the support member 230 are also contemplated including geometrical, non- geometrical, symmetrical, non-symmetrical, cross-sectional profiles. As the term is used herein, the shape of the support member 230 may reference a cross-sectional profile of the support member 230. Different portions of the support member 230 can be variously shaped in other embodiments. For example, the proximal portion 264 can have a larger outer diameter than the outer diameters of the distal portion 262 or a central portion extending between the distal and proximal portions 262, 264.
• an inner diameter of the support member 230 (e.g., the diameter of the lumen 236) can correspondingly increase or decrease as the outer diameter changes. In other embodiments, the inner diameter of the support member 230 remains the same despite variations in the outer diameter.
• a proximal inner member 256 and a proximal outer member 254 are coupled to the proximal portion 264 of the support member 230.
• the proximal inner member 256 and/or the proximal outer member 254 can comprise a flexible elongate member.
• the proximal inner member 256 can be received within a proximal flange 234.
• the proximal outer member 254 abuts and is in contact with the proximal end of flexible substrate 214.
• a distal tip member 252 is coupled to the distal portion 262 of the support member 230.
• the distal member 252 is positioned around the distal flange 232.
• the tip member 252 can abut and be in contact with the distal end of flexible substrate 214 and the stand 242. In other embodiments, the proximal end of the tip member 252 may be received within the distal end of the flexible substrate 214 in its rolled configuration. In some embodiments there may be a gap between the flexible substrate 214 and the tip member 252.
• the distal member 252 can be the distal-most component of the intraluminal imaging device 102.
• the distal tip member 252 may be a flexible, polymeric component that defines the distal-most end of the imaging device 102.
• the distal tip member 252 may additionally define a lumen in communication with the lumen 236 defined by support member 230.
• the guide wire 118 may extend through lumen 236 as well as the lumen defined by the tip member 252.
• One or more adhesives can be disposed between various components at the distal portion of the intraluminal imaging device 102.
• one or more of the flexible substrate 214, the support member 230, the distal member 252, the proximal inner member 256, the transducer array 212, and/or the proximal outer member 254 can be coupled to one another via an adhesive.
• the adhesive can be in contact with e.g. the transducer array 212, the flexible substrate 214, the support member 230, the distal member 252, the proximal inner member 256, and/or the proximal outer member 254, among other components.
• Fig. 5 is a schematic diagram of a processor circuit, according to aspects of the present disclosure.
• the processor circuit 510 may be implemented in the control system 130 of Fig. 1, the intraluminal imaging system 101, and/or the x-ray imaging system 151, or any other suitable location.
• the processor circuit 510 may be in communication with intraluminal imaging device 102, the x-ray imaging device 152, the display 132 within the system 100.
• the processor circuit 510 may include the processor 134 and/or the communication interface 140 (Fig. 1).
• One or more processor circuits 510 are configured to execute the operations described herein.
• the processor circuit 510 may include a processor 560, a memory 564, and a communication module 568. These elements may be in direct or indirect communication with each other, for example via one or more buses.
• the processor 560 may include a CPU, a GPU, a DSP, an application-specific integrated circuit (ASIC), a controller, an FPGA, another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein.
• the processor 560 may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.
• the memory 564 may include a cache memory (e.g., a cache memory of the processor 560), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory.
• the memory 564 includes a non-transitory computer-readable medium.
• the memory 564 may store instructions 566.
• the instructions 566 may include instructions that, when executed by the processor 560, cause the processor 560 to perform the operations described herein with reference to the probe 110 and/or the host 130 (Fig. 1). Instructions 566 may also be referred to as code.
• the terms “instructions” and “code” should be interpreted broadly to include any type of computer-readable statement(s). 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.
• the communication module 568 can include any electronic circuitry and/or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 510, the probe 110, and/or the display 132 and/or display 132.
• the communication module 568 can be an input/output (I/O) device.
• the communication module 568 facilitates direct or indirect communication between various elements of the processor circuit 510 and/or the probe 110 (Fig. 1) and/or the host 130 (Fig. 1).
• Fig. 6 is a diagrammatic view of a graphical user interface 600 for selection of a procedure, according to aspects of the present disclosure.
• the graphical user interface 600 may provide a user with various options prior to an intravascular procedure.
• the graphical user interface 600 may provide a button 610 related to a prestent IVUS procedure and a button 620 related to a post-stent IVUS procedure.
• the graphical user interface 600 may be displayed to a user after a user initiates the IVUS imaging system 100.
• a graphical user interface may be displayed which may guide the user through an intravascular ultrasound procedure within a vessel of a patient which does not include a stent.
• This graphical user interface may additionally provide the user with information related to the vessel of the patient imaged including various metrics related to the position of the ultrasound imaging device throughout the procedure, metrics related to the dimensions or medical condition of the vessel, or any other suitable information.
• a graphical user interface may be displayed which may guide the user through an intravascular ultrasound procedure within a vessel of a patient which includes a stent.
• This graphical user interface may provide the user with tools, metrics, or other features related to assessing the vessel of the patient as well as the stent position within the vessel. Aspects of the graphical user interface displayed to the user after selecting the button 620 will be described with reference to figures hereafter (e.g., Figs. 7-9).
• the imaging system 100 may automatically determine if the procedure to be performed is pre-stent or post-stent. For example, in some aspects, the imaging system 100 may access the medical history of the patient to determine if a stent has been placed within a vessel of patient prior to the procedure and/or if the current imaging procedure is to be performed in that same vessel. If that is the case, the system 100 may proceed to perform the steps related to a post-stent IVUS procedure. If either of these two events is not true, however, the system 100 may perform the steps related to a pre-stent IVUS procedure.
• the system 100 may determine whether the imaging procedure is performed pre-stent or post-stent by analyzing received IVUS or angiographic images. For example, the system 100 may analyze, e.g., by any suitable image processing and/or machine learning algorithms IVUS images or angiographic images received after the current imaging procedure beings or images from prior procedures and determine whether a stent is present within the patient vessel and perform pre-stent or post-stent imaging steps accordingly.
• Fig. 7 is a diagrammatic view of a graphical user interface 700 for selecting rapid review segments, according to aspects of the present disclosure.
• the graphical user interface 700 shown in Fig. 7 includes intravascular ultrasound images 734, 736, and 738, a longitudinal image 750, and an extraluminal image 710.
• IVUS imaging device may acquire IVUS images, such as those shown in Fig. 7.
• IVUS images or intravascular images can be referred to as IVUS image frames or intravascular image frames in some instances.
• the IVUS images acquired may each correspond to a location along the vessel.
• coregistration or other similar methods may be used to identify or correlate the location of each IVUS image acquired.
• the IVUS imaging system 100 may be configured to perform various measurements on the received IVUS images.
• the ultrasound imaging system 100 may be configured to automatically determine whether a stent is shown within an IVUS image.
• the ultrasound imaging system 100 may be configured to automatically identify the stent edge within an IVUS image which includes a stent as well as calculate various metrics related to the stent, such as a stent area.
• the ultrasound imaging system 100 may additionally be configured to identify the distal and proximal and of a stent and identify IVUS images corresponding to those locations.
• the ultrasound imaging system 100 may additionally be configured to automatically identify a location of minimum stent area and identify an IVUS image corresponding to that location.
• the IVUS images shown in Fig. 7 may correspond to a distal edge of the stent, a location of minimal stent area, and a proximal edge of the stent.
• the IVUS image 734 may be automatically identified by the ultrasound imaging system 100 as the IVUS image acquired at a location closest to the distal edge of the stent.
• the ultrasound imaging system 100 may label the IVUS image 734 as the distal edge stent, for example, with the label 721.
• This label 721 may signify that the IVUS image 734 corresponds to the distal edge of the stent as well as identify the number of the IVUS image acquired.
• this number may correspond to the ordinal number of the IVUS image 734 relative to the other IVUS images received.
• the IVUS image 734 may be the 37th image received during an IVUS imaging procedure.
• the graphical user interface 700 may additionally include a distal edge stent area metric 722 associated with the IVUS image 734.
• the IVUS image 736 may be automatically identified by the ultrasound imaging system 100 as the IVUS image with the minimum stent area relative to all other IVUS images acquired during the imaging procedure.
• the ultrasound imaging system 100 may label the IVUS image 736 with a label 723.
• the label 723 may signify that the IVUS image 736 corresponds to the minimum stent area of the stent and provides an ordinal number of the image 736 relative to the other IVUS images received.
• the IVUS image 736 may be the 155th image received during an IVUS imaging procedure.
• a minimum stent area metric 724 associated with the IVUS image 736 is also included.
• the IVUS image 738 may be automatically identified by the ultrasound imaging system 100 as the IVUS image acquired at a location closest to the proximal edge of the stent. Like the images 734 and 736, the ultrasound imaging system 100 may label the IVUS image 738 with a label 725. The label 725 may signify that the IVUS image 738 corresponds to the proximal edge of the stent and provides an ordinal number of the image 738 relative to the other IVUS images received. In the example shown in Fig. 7, the IVUS image 738 may be the 348th image received during an IVUS imaging procedure. A proximal edge stent area metric 726 associated with the IVUS image 736 is also included.
• the longitudinal image 750 of the vessel is also shown in Fig. 7.
• the longitudinal image 750 includes a view of the vessel 770 of the patient, a stent 772 positioned within the vessel 770, a distal edge 774 of the stent, a location of minimum stent area 776, and a proximal edge 778 of the stent.
• the longitudinal image 750 may alternatively be referred to as a longitudinal view.
• the longitudinal image 750 can also be referred to as in-line digital (ILD) display or image longitudinal display (ILD).
• ILD in-line digital
• the IVUS images acquired during an intravascular ultrasound imaging procedure, such as during an IVUS pullback, may be used to create the ILD 750.
• an IVUS image is a tomographic or radial cross-sectional view of the blood vessel.
• the ILD 750 provides a longitudinal cross-sectional view of the blood vessel.
• the ILD 750 can be a stack of the IVUS images acquired at various positions along the vessel, such that the longitudinal view of the ILD 750 is perpendicular to the radial cross-sectional view of the IVUS images.
• the ILD 750 may show the length of the vessel, whereas an individual IVUS image is a single radial cross-sectional image at a given location along the length.
• the ILD 750 may be a stack of the IVUS images acquired over time during the imaging procedure and the length of the ILD 750 may represent time or duration of the imaging procedure.
• the ILD 750 may be generated and displayed in real time or near real time during the pullback procedure. For example, as each additional IVUS image is acquired, it may be added to the ILD 750. For example, at a point in time during the pullback procedure, the ILD 750 shown in Fig. 7 may be partially complete. In some aspects, such as in the example shown in Fig.
• the processor circuit may generate an illustration of a longitudinal view of the vessel based on the received IVUS images.
• the illustration may be a stylized version of the vessel, with e.g., continuous lines showing the lumen border, a stent border, and/or the vessel border.
• the longitudinal image 750 is shown adjacent to a scale 790.
• the scale 790 may indicate locations or distances along the longitudinal image. For example, by co-registration methods, the location of each IVUS image received during an imaging procedure may be known. These location values may be relative to a first image received, or any other reference location along the vessel. In this way, the locations of various IVUS images or features within the longitudinal image 750 may be to scale within longitudinal image 750. In addition, a user of the system may quickly and easily determine distances between features within the image 750.
• the scale 790 may alternatively illustrate time. In that regard, the scale 790 may indicate the time at which IVUS images were received which make up the longitudinal image 750.
• the vessel 770 of the patient shown in the longitudinal image 750 may be a stylized or illustrated depiction of the vessel. For example, a lumen area and average lumen diameter may be automatically calculated for each received IVUS image. This metric for each image may be used to generate the lines corresponding to the vessel 770. For example, the lines corresponding to the vessel 770 may be centrally and/or symmetrically aligned about a center line of the longitudinal image 750.
• the ILD 750 may be an imagebased ILD in which actual depictions of the vessel may be displayed from portions of the acquired IVUS images.
• the graphical user interface may additionally include a metric 793 related to the degree of stent expansion. This metric 793 may relate to an average degree of stent expansion along the stent, a minimum stent expansion, a maximum stent expansion, or any other metric.
• the graphical user interface 700 may include a button 752.
• the button 752 may be configured to receive a user input.
• the processor circuit may toggle between a stylized longitudinal view, or “graphic ILD,” such as the one shown in Fig. 7, and an image-based ILD.
• Aspects of the longitudinal image 750 and button 752 may include some features similar to those described in U.S. Publication No. 2020/0129158 to Chao et al., titled, “Graphical longitudinal display for intraluminal ultrasound imaging and associated devices, systems, and methods” and filed October 24, 2019, which is hereby incorporated by reference in its entirety.
• a graphical representation of the stent 772 is also included in the longitudinal image 750.
• the appearance of the stent 772 may also vary depending on the type of longitudinal image.
• the stent 772 may be shown as a stylized version of a stent.
• the graphical representation could be a graphical element or overlay that is generated by the processor or it could be part of the image content itself.
• the longitudinal image 750 is a graphical ILD
• the graphical presentation of the stent can be a graphical element or overlay that is added to the graphical ILD.
• the longitudinal image 750 is an image -based ILD
• the graphical presentation of the stent may include views of the actual stent struts in the intravascular images or a graphical element/overlay that is added to the image-based ILD.
• the distal edge 774 of the stent 772 is shown in the longitudinal image 750.
• the distal edge 774 of the stent may be automatically determined by the processor (e.g., the processor 510) of the system by reviewing received IVUS images. For example, as IVUS images are received during a pullback procedure, the first image received (e.g., image #1 referring to the ordinal numbers of the labels 721, 723, and 725 previously described) may not include a view of a stent. As additional images are received, the system may assess each image to determine if a stent is present.
• the first IVUS image received during the IVUS imaging procedure which includes a view of a stent may be selected by the system as the IVUS image corresponding to the distal stent edge. In the example shown, this may be image #37 or IVUS image 734 shown. The location of this image may be determined by co-registration, and an illustration of the distal edge of the stent may be positioned at a corresponding location along the longitudinal image 750. An indicator may be overlaid over the longitudinal view at the location of the distal edge 774.
• a physician may assess whether complications related to the stent have occurred. Such complications may be typically at or near stent edges or a location of minimum stent area of the stent. Stent complications may include restenosis, thrombosis, stent edge dissection, and residual plaque, among others. To assess whether these complications have occurred, the physician may perform an IVUS imaging procedure, as described above, and review the acquired IVUS images to determine whether these complications have occurred.
• the physician must typically navigate through hundreds, if not thousands, of IVUS images to first locate the stent and then locate the distal edge of the stent, the location of minimum stent area, and the proximal edge of the stent. The physician may then step through the IVUS images directly surrounding these locations to review for complications. To do so, the physician may iteratively step through IVUS images starting distal or proximal to the location in question to view each image. [0085] To assist a physician in reviewing IVUS images around the distal edge of a stent, the proximal edge of the stent, and the location of minimum stent area of the stent, rapid review segments may be automatically generated by the imaging system 100.
• a rapid review segment may include a series of multiple IVUS images around (e.g., distal and proximal to) a region of interest which are automatically selected by the imaging system 100. These selected images may be displayed in succession, for example, as a video, playthrough, playback, or clip, or a physician may choose to manually step through each or some of the images.
• the imaging system 100 may automatically generate rapid review segments for each of the distal edge of the stent, the proximal edge of the stent, and the location of minimum stent area.
• Indicators along the longitudinal image 750 may illustrate the distal and proximal ends of the rapid review segments for each of these locations, and buttons may be positioned adjacent to these locations for viewing the rapid review segments.
• the distal edge 774 of the stent 772 is shown in the longitudinal image 750.
• the system 100 may generate a rapid review segment for the distal edge.
• the system 100 may be preconfigured with distances or numbers of images distal to and proximal to the image 734 which define a series of IVUS images of the rapid review segment. For example, the system 100 may select all IVUS images within 5 mm distal of the distal edge 774 and all images within 1 mm proximal of the distal edge 774 as the images of a rapid review segment.
• lengths may be any suitable lengths, and the values provided herein are merely exemplary.
• the user may select any suitable lengths proximal to and distal to the stent edges as default lengths or adjust these lengths at any other time.
• a use may specify a length or number of IVUS images distal to the distal stent edge, and a different length or number of IVSU images proximal to the distal stent edge. Different lengths and numbers of images may be selected corresponding to the proximal stent edge and/or other region along the interior of the stent as well.
• An indicator 761 may be positioned on the longitudinal image 750 identifying the distal end of the rapid review segment for the distal edge 774 and an indicator 763 may identify the proximal end of the rapid review segment.
• the rapid review segment for the distal edge of the stent may include a series of IVUS images from the indicator 761 to the indicator 763 (e.g., the IVUS images depicting a region of the blood vessel proximate to the distal edge).
• a button 762a is shown adjacent to the longitudinal image 750 and above the distal edge 774.
• a user of the system may select the button 762a to view the rapid review segment associated with the distal edge 774.
• An additional button 762b may be displayed proximal to the IVUS image 734 corresponding to the distal edge 774.
• the user may alternatively or additionally select this button 762b to view the rapid review segment associated with the distal edge 774.
• a similar button may be positioned near the location of the distal edge of the stent within the extraluminal image 710. Any of these buttons 762 may direct the imaging system to show a graphical user interface with the rapid review segment associated with the distal edge 774. Such a graphical user interface may be similar to those shown in Figs. 8-9 hereafter.
• Similar rapid review segments and corresponding indicators and buttons may be generated for the proximal edge 778 and location of minimum stent area 776.
• the proximal edge 778 of the stent 772 is shown in the longitudinal image 750.
• the system 100 may generate a rapid review segment for the proximal edge.
• the system 100 may be preconfigured with distances or numbers of images distal to and proximal to the image 738 which define the rapid review segment.
• the system 100 may select all IVUS images within 5 mm proximal of the proximal edge 778 and all images within 1 mm distal of the proximal edge 778 as the images of a rapid review segment.
• An indicator 767 may be positioned on the longitudinal image 750 identifying the distal end of the rapid review segment for the proximal edge 778 and an indicator 769 may identify the proximal end of the rapid review segment.
• the rapid review segment for the proximal edge of the stent may include a series of IVUS images from the indicator 767 to the indicator 769 (e.g., the IVUS images depicting a region of the blood vessel proximate to the proximal edge).
• each rapid review segment may include a location of a region of interest (e.g., distal edge 774, proximal edge 778, or a location of minimum stent area 776), a distal boundary (e.g., indicators 761, 764, or 767), and a proximal boundary (e.g., indicators 763, 766, or 769).
• the distance between the location of interest and the distal boundary may be the same or different from the distance between the location of interest and the proximal boundary. These distances may vary based on the type of location of interest.
• the rapid review segments do not overlap (e.g., the rapid review segment for one stent feature does not include an intravascular image frame that forms part of the rapid review segment for another stent feature).
• a first subset of intravascular image frames forming the rapid review segment for the stent distal edge 774 does not include an intravascular image frame forming part of the rapid review segment for the stent proximal edge 778 and vice versa.
• the first subset does not include the intravascular image frame 734 with the proximal edge 778 and the second subset does not include the intravascular image frame 738 with the distal edge 774.
• the rapid review segments can overlap (e.g., the rapid review segment for one stent feature can include an intravascular image frame that forms part of the rapid review segment for another stent feature).
• the distance from the distal stent edge to the distal boundary may be greater than the distance from the distal stent edge to the proximal boundary.
• the rapid review segment may be generated such that is biased toward the distal end outside of the stent.
• the distance from the proximal stent edge to the proximal boundary may be greater than the distance from the proximal stent edge to the distal boundary.
• the rapid review segment may be generated such that is biased toward the proximal end outside of the stent.
• the rapid review segment may be generated such that is biased toward showing more length of the vessel outside of the stent, the physician may more easily identify a potential stent dissection.
• the location of interest corresponds to a location of minimum stent area
• the distance from the location of interest to the distal boundary and the distance from the location of interest to the proximal boundary may be the same.
• the location of interest may be between the distal and proximal boundaries of a rapid review segment.
• a subset of the IVUS images of the rapid review segment may depict the stent. For example, if the location of interest of a rapid review segment is a proximal or distal edge of a stent, a percentage (e.g., 10%, 15%, 20%, 25%, 50%, etc.) of the IVUS images of the rapid review segment may depict the stent. If the location of interest corresponds to a location of minimum stent diameter, all of the IVUS images of the rapid review segment may depict a stent, or some percentage of the IVUS images may depict a stent. [0093] As shown in Fig.
• distal and proximal boundaries of any rapid review segments may be adjusted by a user.
• a user may select any of the distal boundaries (e.g., indicators 761, 764, or 767) or proximal boundaries (e.g., indicators 763, 766, or 769) and move them to a different location thus modifying the length or the starting or ending IVUS images of rapid review segments.
• This ability may be shown by the indicator 792.
• the indicator 792 may be generated when a user positions a mouse over the any of the boundaries listed indicating that they may be moved in a proximal or distal direction.
• a button 768a similar to the button 762a, is shown adjacent to the longitudinal image 750 and above the proximal edge 778.
• a user of the system may select the button 768a to view the rapid review segment associated with the proximal edge 778.
• An additional button 768b may be displayed proximal to the IVUS image 738 corresponding to the proximal edge 778.
• the user may alternatively or additionally select this button 768b to view the rapid review segment associated with the distal edge 778.
• a similar button may be positioned near the location of the proximal edge of the stent within the extraluminal image 710. Any of these buttons 768 may direct the imaging system to show a graphical user interface with the rapid review segment associated with the distal edge 778. Such a graphical user interface may be similar to those shown in Figs. 8-9 hereafter.
• the location 776 of the minimum stent area of the stent 772 is shown in the longitudinal image 750.
• the system 100 may generate a rapid review segment for the minimum stent area location 776.
• the system 100 may be preconfigured with distances or numbers of images distal to and proximal to the image 736 which define the rapid review segment. For example, the system 100 may select all IVUS images within 3 mm proximal of the location 776 and all images within 3 mm distal of the location 776 as the images of a rapid review segment.
• An indicator 764 may be positioned on the longitudinal image 750 identifying the distal end of the rapid review segment for the location 776 and an indicator 766 may identify the proximal end of the rapid review segment.
• the rapid review segment for the minimum stent area location 776 may include a series of IVUS images from the indicator 764 to the indicator 766 (e.g., the IVUS images depicting a region of the blood vessel proximate to the minimum stent area).
• a button 765a similar to the buttons 762a and 768a, is shown adjacent to the longitudinal image 750 and above the location 776.
• a user of the system may select the button 765a to view the rapid review segment associated with the location 776.
• An additional button 765b may be displayed proximal to the IVUS image 736 corresponding to the location 776.
• the user may alternatively or additionally select this button 765b to view the rapid review segment associated with the minimum stent area location 776.
• a similar button may be positioned near a location of minimum stent area within the extraluminal image 710. Any of these buttons 765 may direct the imaging system to show a graphical user interface with the rapid review segment associated with the minimum stent area location 776. Such a graphical user interface may be similar to those shown in Figs. 8-9 hereafter.
• the extraluminal image 710 may be included in the graphical user interface 700.
• the extraluminal image 710 may be an x-ray image, an angiographic image, a fluoroscopic image, or any other suitable extraluminal image.
• the extraluminal image 710 may be one of many extraluminal images obtained during an imaging procedure. For example, multiple extraluminal images may have been obtained and co-registered to the multiple IVUS images. These extraluminal images may be used to identify the locations at which the IVUS images were received.
• the extraluminal image 710 may include a depiction of the vessel 770.
• the extraluminal image 710 may additionally include a depiction of the stent within the vessel 770.
• An indicator 782 may be positioned overlaid over the extraluminal image 710 corresponding to the stent.
• indicators identifying the distal edge, proximal edge, and location of minimum stent area of the stent may be identified.
• the indicator 784 may identify the distal edge of the stent.
• the indicator 788 may identify the proximal end of the stent.
• the indicator 786 may identify the location of minimum stent area.
• the graphical user interface 700 may additionally include a button 760.
• the button 760 may correspond to a rapid review graphical user interface. Like the buttons 762, 765, and 768 described previously, the button 760 may receive a user input and direct the imaging system to display a graphical user interface related to a rapid review segment, including any of the rapid review segments described with reference to Fig. 7, or any other rapid review segments. In some aspects, a selection of the button 760 may cause the imaging system 100 to display a list of all rapid review segments generated by the system and a user may select the rapid review segment they wish to view.
• Fig. 8 is a diagrammatic view of a graphical user interface 800 including aspects of a rapid review segment, according to aspects of the present disclosure.
• the graphical user interface 800 may be a graphical user interface displayed to a user after selecting one of the buttons 762, 765, 768, and/or 760 of Fig. 7.
• the graphical user interface 800 shown in Fig. 8 may correspond to a rapid review segment for the location of minimum stent area 776.
• the graphical user interface 800 may be displayed to a user after selecting the button 765a. After the user selects the button 765a corresponding to the location of the minimum stent area, a highlighted region 854 may be displayed between the indicators 764 and 766, an IVUS image (such as the IVUS image 834 shown), a label 821 and stent area 822, and a series of control buttons related to the IVUS image may be displayed.
• the IVUS image 834 shown in Fig. 8 may be one of a series of IVUS images selected by the imaging system as the rapid review segment associated with the location 776.
• the rapid review segment for the location 776 may include each IVUS image between the indicators 764 and 766.
• the rapid review segment for the location 776 may include some subset of these images.
• the rapid review segment may include every other image in the series, every third image, or images selected to any other pattern.
• the user of the system may choose whether the rapid review segment includes all images within the range shown or some other subset.
• the imaging system 100 may display the most distal IVUS image of the rapid review segment. For example, this image may be an image corresponding to the indicator 764. A user may then select a play /pause button 843. Upon receiving the user input selecting the play/pause button 843, the imaging system 100 may rapidly display the IVUS images of the rapid review segment in series beginning with the most distal image. In some aspects, the imaging system 100 may automatically begin to play the rapid review segment in response to the selection of the button 765 a.
• the user may select a loop button 840 to direct the imaging system to repeat the display of the series of images (e.g., rapid review segment sometimes characterized as a video segment) indefinitely, or to play the series of images only once and then to stop.
• a label 821 may be continuously updated to show the ordinal number of the IVUS image displayed and a scrubber 870 may be moved along the longitudinal view 750.
• the scrubber 870 may identify the location along the longitudinal image 750 at which the displayed IVUS image was obtained.
• Fig. 8 may illustrate a still view of the graphical user interface as the rapid review segment is played.
• the IVUS image 834 may be one of the series of images of the rapid review segment and may have been obtained at the location shown by the scrubber 870.
• a scrubber may additionally be positioned over the stent within the extraluminal image 710. This scrubber, like the scrubber 870, may indicate the position of the displayed IVUS image and may be updated as the rapid review segment is played.
• the extraluminal image 710 may additionally include indicators similar to the indicators 761, 763, 764, 766, 767, and/or 769 identifying distal and proximal boundaries of rapid review segments.
• a user of the system may navigate through the series of images with other buttons shown below the IVUS image 834. For example, a user may navigate to the most distal image of the rapid review segment (e.g., corresponding to the indicator 764) by selecting the button 841. Similarly, the user may navigate to the most proximal image of the rapid review segment (e.g., corresponding to the indicator 766) by selecting the button 845.
• buttons 842 and/or 844 e.g., the button 842 causing the image adjacent and distal to the image displayed to be displayed and the button 844 causing the image adjacent and proximal to the image displayed to be displayed.
• a user may adjust the rate at which IVUS images are displayed by selecting the button 846. For example, the user may wish to speed up or slow down the rapid review segment by toggling between different rates displayed after selecting the button 846 (e.g., i speed, 2x speed, etc.).
• the stent area 822 for each displayed IVUS image may be continuously updated as IVUS images of the rapid review segment displayed.
• the stent area metric 822 may correspond to the calculated stent area of the IVUS image displayed.
• an indicator 789 is shown extending along a portion of the stent 782 in the angiographic image 710 in Fig. 8.
• the indicator 789 may be positioned adjacent to the vessel or stent shown in the extraluminal image 710.
• This indicator 789 may identify for a user the locations at which the IVUS images corresponding to a central rapid review segment (e.g., corresponding to the segment of button 765 a and corresponding indicators of the ILD 750) were obtained.
• the indicator 789 may correspond to the highlighted region 854 of the ILD 750.
• the length and position of the highlighted region 854 relative to the stent shown in ILD 750 may correspond to the length and position of the indicator 789 relative to the stent of the extraluminal image 710.
• other indicators identifying the locations at which IVUS images were obtained corresponding to any other rapid review segments, including those corresponding to the distal and/or proximal edges of the stent may be generated and displayed within the extraluminal image 710.
• Fig. 9 is a diagrammatic view of a graphical user interface including aspects of a rapid review, according to aspects of the present disclosure.
• the graphical user interface 900 may be a graphical user interface displayed to a user after selecting one of the buttons 762, 765, 768, and/or 760 of Fig. 7.
• the graphical user interface 900 may correspond to a rapid review segment for the distal edge 774.
• the graphical user interface 900 may be displayed to a user after selecting the button 762a. After the user selects the button 762a corresponding to the location of the distal edge of the stent, a highlighted region 954 may be displayed between the indicators 761 and 763, an IVUS image (such as the IVUS image 934 shown), a label 921 and stent area 922, and a series of control buttons related to the IVUS image may be displayed.
• the IVUS image 934 shown in Fig. 9 may be one of a series of IVUS images selected by the imaging system as the rapid review segment associated with the distal stent edge 774.
• the rapid review segment for the distal edge 774 may include each IVUS image between the indicators 761 and 763. In some aspects, the rapid review segment for the distal edge 774 may include some subset of these images, as described with reference to Fig. 8. [00113] After a user selects the button 762a, the imaging system 100 may display the most distal IVUS image of the rapid review segment. For example, this image may be an image corresponding to the indicator 761. A user may then select the play/pause button 843 causing the IVUS images of the rapid review segment to be sequentially displayed. After a user selects the button 762a, the highlighted region 954 may be displayed identifying the region corresponding to the rapid review segment.
• an outline 952 may be displayed around the button 762a to further identify to the user that the rapid review segment corresponds to the distal edge of the stent as opposed to other regions of interest or other rapid review segments generated (e.g., the proximal edge). Similar to the labels 821 and 822 described with reference to Fig. 8, the label 921 and stent area metric 922 may be continuously updated as the IVUS images are sequentially displayed. Similarly, as the series of images are displayed, the scrubber 870 may be moved along the longitudinal view 750 identifying the location along the longitudinal image 750 at which the displayed IVUS images were obtained.
• a user of the system may manipulate aspects of the rapid review segment as well as navigate through the series of images with the buttons 840- 846 below the IVUS image 934.
• Similar graphical user interfaces may be generated for rapid review segments corresponding to any other location along the longitudinal image 750.
• a graphical user interface like the graphical user interfaces 700 and 800 may be generated and displayed corresponding to the rapid review segment for the proximal edge 778.
• a rapid review segment for the proximal edge 774 may include the IVUS images obtained at locations from the indicator 767 to the indicator 769. These images may be sequentially displayed, like the sets of IVUS images described with reference to Figs. 8-9.
• graphical elements may additionally identify that the rapid review segment shown corresponds to the proximal edge. For example, a highlighted region may be overlaid over the longitudinal image 750 from the indicators 767 to 769, like the region 854, or an outline may be positioned around the button 768a, like the outline 952.
• a similar graphical user interface could be generated related to any location along the longitudinal image 750.
• the imaging system 100 may be configured to receive a user input selecting any location along the longitudinal view 750 or the extraluminal image 710, including locations along the stent or locations which do not correspond to the stent.
• the imaging system 100 may generate a rapid review segment. This process may include receiving the user input selecting a location along either the longitudinal image 750 or the extraluminal image 710 and determining a proximal boundary and distal boundary a set distance on either side of the selected location.
• the system 100 may identify an IVUS image positioned as close as possible to 3 mm distal of the selected location and provide an indicator (e.g., like the indicators 761 or 767) on the longitudinal view 750 identifying that location.
• the system 100 may identify an image about 3 mm proximal to the selected location and provide an indicator (e.g., like the indicators 763 and 769) on the longitudinal image 750.
• the system 100 may then sequentially display the set of images between these distal and proximal boundaries allowing the user to review this rapid review segment for complications, as explained previously.
• Fig. 10 is a schematic diagram of acquired ultrasound images 1030 and corresponding locations along the vessel 780 of a patient, according to aspects of the present disclosure.
• FIG. 10 may provide one method of identifying a set of IVUS images for a rapid review segment.
• Fig. 10 includes a view of the vessel 780. Positioned above the vessel 780 is a scale 1080. Above the scale 1080 is a number of vertical line indicators representing IVUS images 1030 received during an IVUS imaging procedure. The locations of the IVUS images 1030 in Fig. 10 may correspond to the locations at which the IVUS images were obtained during an imaging procedure. As shown in Fig. 10, the locations of the IVUS images 1030 may not be consistently spaced. This may be a result of the pullback procedure being performed by hand. In that regard, the IVUS imaging device may move at varying rates through the vessel 780 during the imaging procedure.
• the vessel 780 may include a diagrammatic view of a stent 1072.
• the stent 1072 may include a distal edge 1073. As described previously, based on coregistration, a location of the distal edge 1073 may be identified by the imaging system 100. This location may serve as an origin of the scale 1080 shown in Fig. 10.
• the rapid review segment generated may correspond to 5 mm distal of the distal edge 1073 and 1 mm proximal of the distal edge 1073.
• a distal direction may be identified by the arrow 1096 and a proximal direction may be identified by the arrow 1097.
• the system may identify a location 1032 5 mm distal of the distal edge 1073.
• no IVUS image 1030 may have been obtained exactly at the location 1032.
• the system 100 may identify the IVUS image closest to the location 1032. In the example shown in Fig. 10, this may be the IUVS image 1030a proximal to the location 1032.
• the system 100 may select this image as the image corresponding to the distal boundary of the rapid review segment and may designate this image 1030a as the first IVUS image of the set of IVUS images which may make up the rapid review segment corresponding to the distal edge 1073.
• a similar procedure may be used to identify the proximal boundary of the rapid review segment.
• a location 1034 may be identified 1 mm proximal to the distal edge 1073.
• no IVUS image 1030 may have been obtained at exactly this location 1034.
• the closest IVUS image may be selected.
• the IVUS image 1030d is, just distal of the location 1034 may be selected as the IVUS image corresponding to the proximal boundary of the rapid review segment.
• the rapid review segment may include all the IVUS images 1030 including and between the IVUS image 1030a and the IVUS image 1030d.
• an approximation of a rapid review segment may still be made if coregistration is not performed.
• some imaging systems may not include an extraluminal imaging system.
• any of the graphical user interfaces 700, 800, or 900 may not include the extraluminal image 710.
• the locations of the IVUS images 1030 may not be known by coregistration.
• the imaging system 100 may not be able to identify the IVUS image 1030 closest to specific locations along the longitudinal image 750 (e.g., 5 mm distal or 1 mm proximal to the distal edge 1073) based on an association of the IVUS images 1030 to specific locations along the vessel.
• the imaging system 100 may still approximate the IVUS image 1030 closest to particular locations relative to other IVUS images.
• distances between obtained IVUS images 1030 based on coregistration may be based on one or more x-ray images obtained by an x-ray imaging device (e.g., the extraluminal imaging system 151).
• a position at which an IVUS image 1030 was obtained may be identified by identifying the IVUS imaging device within or more extraluminal images.
• Distances within extraluminal images may be determined based on sizes of objects within the extraluminal images relative to a known dimension of the IVUS imaging device. For example, the user may provide an input specifying the size of the catheter of the IVUS imaging device.
• the system 100 may be preconfigured with the dimensions of the catheter of the IVUS imaging device.
• the system 100 may be preconfigured with dimensional information of a plurality of catheters. The system 100 may automatically detect the type of catheter used for the imaging procedure and retrieve the appropriate dimension of that catheter for measurement purposes.
• the system 100 may present a list of the catheters within its database to the user and the user may select which catheter is being used for the particular imaging procedure. The system 100 may then retrieve the dimensions of the selected catheter.
• the imaging system 100 may obtain a no-contrast x-ray image frame depicting the catheter of the IVUS imaging device.
• the user may then input a dimension of the device (e.g., 3 Fr).
• the imaging system 100 may then make measurements within the extraluminal image relative to this known length.
• the IVUS image 1030c may be identified as the first IVUS image obtained which shows the stent 1072. Based on an expected or average rate of speed of the IVUS imaging device during the imaging procedure and an image acquisition rate of the device, distances between IVUS images may be approximated. In some aspects, the determination of the rate of speed of the IVUS imaging device may be performed during the procedure or prior to the procedure. For example, the system 100 may retrieve a default rate of speed of the catheter. This default may be pre-configured by a user. In aspects in which the system 100 estimates an average rate of speed of the catheter during a procedure based on movement of the catheter, the system may determine, if neighboring IVUS image frames are highly similar or correlated, that the pullback speed is slower.
• the pullback speed may be determined to be higher.
• This IVUS data may alone be used to determine the average rate of speed.
• this IVUS data may be combined with data from an extraluminal imaging device identifying movement of the IVUS imaging catheter and estimating the speed based on the observed movement.
• an artificial intelligence algorithm may be used to determine the average speed of the IVUS imaging device. For example, during an imaging procedure, the IVUS imaging device may be determined to have moved at an average speed of 2 mm/sec. In addition, the IVUS imaging device may have acquired IVUS images at an acquisition rate of 30 frames/sec.
• the imaging system 100 may determine that 1 mm corresponds to about 15 IVUS image frames. As a result, after determining the IVUS image 1030c as the location of the distal edge 1073, the system 100 may count 75 frames distal of the image 1030c, identifying the IVUS image 1030b as the IVUS image corresponding to the distal boundary. In this example, the image 1030b may serve as the first IVUS image of the rapid review segment. In a similar way, the imaging system 100 may count 15 images proximal to the image 1030c to identify the image 1030e as the proximal boundary of the rapid review segment.
• the rapid review segment may include each of the images including and between the IVUS images 1030b and 1030e.
• fewer than all of the IVUS images 1030 may be displayed in Fig. 10 to simplify the illustration.
• the number of IVUS images 1030 shown in Fig. 10 may correspond to l/3 rd of the total IVUS images obtained.
• the number of IVUS images 1030 displayed between the IVUS images 1030c and 1030b may be 25 and the number of IVUS images 1030 displayed between the IVUS images 1030c and 1030e may be 5.
• IVUS images 1030 may be displayed and that the IVUS imaging device may move at any suitable speed and acquire IVUS images at any suitable rate during an IVUS imaging procedure.
• the imaging system 100 may approximate distances according to the principles described herein using any suitable values of device speed or acquisition rate.
• the images selected as part of a rapid review segment may differ depending on whether coregistration is used to determine IVUS image locations or not.
• the rapid review segment may include the intravascular images 1030 acquired along the distance 1098.
• the rapid review segment may include the intravascular images 1030 acquired along the distance 1099 shown in Fig. 10, which may differ from the distance 1098. In some aspects, the distances 1098 and 1099 may be the same.
• the processor circuit can control play through of all of the intravascular images that were obtained during movement of the intravascular imaging procedure (e.g., during a pullback). This can be considered as a video of the intravascular imaging procedure (e.g., all of the plurality of intravascular images obtained during the pullback).
• a video of the intravascular imaging procedure e.g., all of the plurality of intravascular images obtained during the pullback.
• aspects of the present disclosure advantageously identify and/or play through only a set, subset, segment, or portion of the intravascular images (e.g., only a video segment or only a portion of the whole video).
• the set, subset, segment, or portion of the intravascular images can be referred to as a rapid review segment.
• the quantity of intravascular images or image frames that make up the rapid review segment can be less than the total number of intravascular images or image frames that were obtained during the intravascular imaging procedure (e.g., during the pullback).
• the processor circuit automatically identifies intravascular image frame(s) with the stent feature and automatically identifies the image frames associated with that stent feature.
• the image frames associated with the stent feature can be spatially associated, such as the image frames within a given distance and/or quantity of frames proximal of the stent feature, the images frames within a given distance and/or quantity of frames distal of the stent feature, etc.
• Having the rapid review segment be asymmetric relative to the image frame with the stent feature may be advantageous in that more locations of the blood vessel where a clinically relevant event is likely to occur (e.g., a dissection of the blood vessel proximate to the distal edge or the proximal edge) are included.
• the method 1100 includes a number of enumerated steps, but aspects of the method 1100 may include additional steps before, after, or in between the enumerated steps. In some aspects, one or more of the enumerated steps may be omitted, performed in a different order, or performed concurrently.
• the steps of the method 1100 can be carried out by any suitable component within the system 100 and all steps need not be carried out by the same component. In some aspects, one or more steps of the method 1100 can be performed by, or at the direction of, a processor circuit, including, e.g., the processor 510.
• the method 1100 includes controlling the intravascular imaging device to obtain a plurality of intravascular image frames while the intravascular imaging device is moved through a blood vessel with a stent.
• the intravascular imaging device may be any suitable intraluminal device for any suitable system.
• the intravascular imaging device may include an IVUS imaging device, an OCT imaging device, an intravascular photoacoustic (IVPA) imaging device, or any other device.
• IVPA intravascular photoacoustic
• method 1100 describes the intravascular device positioned within a blood vessel, the device may alternatively be positioned in any suitable lumen, such as a blood vessel, such as a coronary vessels, a ureter, an esophagus, any other digestive lumen, or any other lumen.
• the intravascular device may include a catheter, a guidewire, a guide catheter, or any other suitable device.
• the region of the blood vessel proximate to the feature of the stent includes the location of the vessel with the feature of the feature of the stent, as well as the plurality of locations of the vessel that are distal of and proximal of the feature of the stent.
• the method 1100 includes identifying a second intravascular image frame of the plurality of intravascular image frames.
• the second intravascular image frame is obtained at a second location within the blood vessel that is distal of the first location.
• the first intravascular image frame corresponds to a distal edge of the stent
• the second intravascular image frame may not depict the stent.
• a subset of image frames between the second intravascular image frame and the first intravascular image frame may not depict the stent.
• the first intravascular image frame corresponds to a proximal edge of the stent
• the second intravascular image frame and subset of frames between the second intravascular image frame and the first intravascular image frame may depict the stent.
• the first intravascular image frame corresponds to a location of minimum stent area
• the second intravascular image frame and subset described above may or may not depict the stent.
• the method 1100 includes generating an output based on a subset of the plurality of intravascular image frames.
• the subset comprises intravascular image frames between the second intravascular image frame and the third intravascular image frame such that the subset comprises the first intravascular image frame.
• the output may include any suitable display element.
• the output may be an indicator positioned on a graphical user interface, such as any of those shown and described with reference to Figs. 7-9.
• the output may include a highlighted region overlaid over an ILD, an angiographic image, or any IVUS images.
• the output may include indicators overlaid on the ILD or angiographic images described herein at proximal or distal locations of the series of images corresponding to the rapid review segment.
• the output may be a button within the graphical user interface.
• the output may be a video segment.
• the output may be a clip, loop, or playthrough of all or part of the IVUS images of the subset.
• the subset of image frames between the second intravascular image frame and the third intravascular image frame may include or exclude both or either of the second or third intravascular image frames.
• the method 1100 includes outputting, to the display, a screen display comprising the output.
• the processor is configured to identify the first intravascular image frame, identify the second intravascular image frame, identify the third intravascular image frame, and generate the output automatically without a user input.
• the processor may automatically identify the first intravascular image frame, second intravascular image frame, and/or the third intravascular image frame and generate the output in response to a user input identifying the procedure as a post-stent check, the user indicating the procedure is performed in a vessel with a stent in position, and/or the completion of a pullback (e.g., the acquisition of the ultrasound image frames from a distal location of the vessel to a proximal location of the vessel, for the imaging procedure).
• a pullback e.g., the acquisition of the ultrasound image frames from a distal location of the vessel to a proximal location of the vessel, for the imaging procedure.

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