Positional synchronization of endoluminal data to non-contrast x-ray image frames and related systems, devices and methods - Patents.com

Abstract

The system includes a processor circuit that receives an extraluminal image acquired without contrast. The processor circuit receives a plurality of additional extraluminal images acquired without contrast while the endoluminal device is moved within the patient's body cavity. A position of the endoluminal device is tracked and used to form a curve. The curve is superimposed on one of the extraluminal images acquired without contrast. The curve and the extraluminal image are displayed to a user for modification or approval. Endoluminal data points acquired by the endoluminal device are then positionally synchronized to the extraluminal image. The extraluminal image and the endoluminal data are displayed to a user.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001]

[0001] This application claims priority to and the benefit of U.S. Provisional Application No. 63 / 292,529, filed December 22, 2021, which is incorporated by reference in its entirety. [Technical field]

[0002]

[0002] This disclosure relates generally to coregistration of endoluminal and extraluminal data, particularly where the endoluminal data is coregistrated to x-ray images acquired without contrast injection. [Background technology]

[0003]

[0003] Physicians use a variety of medical diagnostic systems and tools to monitor the health of patients and diagnose and treat medical conditions. The various modalities of medical diagnostic systems may provide physicians with multiple different images, models, and / or data about structures within the patient's body. These modalities include invasive devices and systems, such as intravascular systems, as well as non-invasive devices and systems, such as external ultrasound or x-ray systems. Using multiple diagnostic systems to examine a patient's anatomy can provide physicians with further insight into the patient's condition.

[0004]

[0004] In the field of intravascular imaging and physiological measurements, positional synchronization of data from invasive devices (e.g., intravascular ultrasound (IVUS) devices) with images collected non-invasively (e.g., by x-ray angiography and / or x-ray venography) is a powerful technique for improving the efficiency and accuracy of vascular catheterization procedures. Positional synchronization locates intravascular data measurements along a vessel by mapping the data onto an x-ray image of the vessel. This allows a physician to see on the angiographic image the exact location along the vessel where a measurement was made, rather than estimating the location. Summary of the Invention [Problem to be solved by the invention]

[0005]

[0005] Positional synchronization of endovascular data to a location along the blood vessels typically requires the introduction of a contrast agent into the patient's vascular system. The contrast agent causes blood vessels that are not naturally radiopaque to appear in an x-ray image. When displayed to the user, the location of the endovascular data is shown along the contrast-filled blood vessels in the x-ray image. However, the introduction of the contrast agent is time consuming and prone to errors. Additionally, some patients may be reluctant to swallow the contrast agent, which can cause discomfort.

[0006]

[0006] An embodiment of the present disclosure is a system, device, and method for positional synchronization of endoluminal data and / or annotations to a location along a blood vessel in an x-ray image acquired without contrast. In a non-contrast x-ray image, the blood vessel itself is not visible in the image. Aspects of the present disclosure advantageously allow a user to perform positional synchronization with a non-contrast x-ray image or a low-dose contrast x-ray image. This has the advantage that for patients with chronic kidney disease (CKD) or other sensitivities to x-ray contrast, positional synchronization procedures can be performed without exposure to contrast dye. This also allows patients, especially those with CKD, to be discharged the same day after a positional synchronized endoluminal procedure with less concern about developing contrast-induced nephropathy (CIN). Same-day discharge is cost-effective and safer for the patient, and has been shown to be safe even after highly complex interventions. [Means for solving the problem]

[0007] Aspects of the invention may include zero-contrast position synchronization and / or position synchronization workflow optimization in an x-ray-guided interventional vascular procedure without contrast injection. Multiple zero-contrast x-ray images are acquired during an endovascular procedure. A radiopaque portion of an endovascular device appears in each zero-contrast x-ray image. The location of the device in each image forms a path. The path is then processed to determine a motion-corrected centerline path. This motion-corrected centerline path is overlaid on one of the zero-contrast x-ray images. The path is then displayed to a user. The user can edit the shape of the path and / or approve that the shape of the path is correct. The location where the endovascular data was collected is associated with a location along the path, allowing the physician to see where the endovascular data was acquired in the x-ray images.

[0008] In one exemplary aspect, a system is provided that includes a processor circuit in communication with an extraluminal imaging device and an endoluminal catheter or guidewire, the processor circuit receiving a first extraluminal image acquired by the extraluminal imaging device, receiving a plurality of second extraluminal images acquired by the extraluminal imaging device during movement of the endoluminal catheter or guidewire within the patient's body cavity, the plurality of second extraluminal images being acquired without contrast agent within the body cavity, receiving a plurality of endoluminal data points acquired by the endoluminal catheter or guidewire during movement, and determining at least a shape or a position of the body cavity based on the plurality of second extraluminal images. the first extraluminal image being acquired without a contrast agent in the body cavity; determining whether the first extraluminal image was acquired without a contrast agent in the body cavity; in response to determining that the first extraluminal image was acquired without a contrast agent in the body cavity, assigning the curve in the first extraluminal image as a centerline of the body cavity; position-synchronizing a plurality of endoluminal data points to positions along the curve; and outputting a first screen representation on a display in communication with the processor circuit, the first screen representation including the first extraluminal image, a visual representation of the endoluminal data point of the plurality of endoluminal data points, and a marking superimposed on the extraluminal image at a corresponding location of the endoluminal data point.

[0009] In one aspect, in response to determining that the first extraluminal image was acquired without contrast in the body cavity, the processor circuit outputs a second screen display to the display, the second screen display including the first extraluminal image and a curve superimposed on the first extraluminal image. In one aspect, the second screen display includes a plurality of user input options for at least one of accepting the centerline, correcting the centerline, or drawing a new centerline. In one aspect, if the user input option for correcting the centerline is selected, the processor circuit receives user input to identify a region of the curve and selects a new location in the first extraluminal image corresponding to the corrected location of the region. In one aspect, the processor performs position synchronization and outputs the first screen display only after receiving user input via the plurality of user input options. In one aspect, the processor circuit is in communication with a touch screen display, the processor circuit outputs the first screen display to the touch screen display, and the processor circuit receives user input from the touch screen display. In one aspect, the extraluminal imaging device includes an x-ray imaging device. In one aspect, a first extraluminal image is acquired at a first radiation dose, and a plurality of second extraluminal images are acquired at a second radiation dose less than the first radiation dose. In one aspect, a processor circuit receives a plurality of first extraluminal images acquired by an extraluminal imaging device and selects a first extraluminal image from among the plurality of first extraluminal images. In one aspect, the processor circuit automatically determines whether the first extraluminal image was acquired without contrast without receiving a user input to identify whether the first extraluminal image was acquired without contrast. In one aspect, the plurality of second extraluminal images show radiopaque portions of an intraluminal catheter or guidewire, and the processor circuit determines a curve based on the radiopaque portions shown in the plurality of second extraluminal images. In one aspect, the plurality of second extraluminal images are acquired during a plurality of anatomical cycles such that the intraluminal catheter or guidewire experiences cyclical motion while passing through a body cavity, and to determine the curve, the processor circuit performs motion compensation.In one embodiment, to perform motion compensation, the processor circuitry further places a curve along a center of a shape generated by the movement of the intraluminal catheter or guidewire within the body cavity while the intraluminal catheter or guidewire experiences periodic motion. In one embodiment, the first extraluminal image is one of a plurality of second extraluminal images. In one embodiment, the processor circuitry further assigns the curve as a centerline of the body cavity in the first extraluminal image without identifying the body cavity in the first extraluminal image and without identifying a centerline in the first extraluminal image.

[0010] In one exemplary aspect, a method is provided that includes receiving, by a processor circuit in communication with the extraluminal imaging device, a first extraluminal image acquired by the extraluminal imaging device, receiving, by the processor circuit, a plurality of second extraluminal images acquired by the extraluminal imaging device during movement of an endoluminal catheter or guidewire within a body cavity of a patient, the plurality of second extraluminal images being acquired without contrast within the body cavity, receiving, by the processor circuit, a plurality of endoluminal data points acquired by the endoluminal catheter or guidewire during movement, determining, by the processor circuit, a curve representing at least one of a shape or position of the body cavity based on the plurality of second extraluminal images, determining, by the processor circuit, whether the first extraluminal image was acquired without contrast within the body cavity, and In response to the processor circuit determining that one extraluminal image was acquired without contrast agent within the body cavity (e.g., a processor circuit that determines that the extraluminal image was acquired without contrast agent performs the following steps), the processor circuit assigns a curve as a centerline in the first extraluminal image without identifying the body cavity in the first extraluminal image and without identifying a centerline of the body cavity in the first extraluminal image, the processor circuit positionally synchronizes a plurality of endoluminal data points to positions along the curve, and outputting a first screen display on a display in communication with the processor circuit, the first screen display including the first extraluminal image, a visual representation of an endoluminal data point of the plurality of endoluminal data points, and a marking superimposed on the extraluminal image at a corresponding position of the endoluminal data point.

[0011] In one exemplary aspect, a system is provided that includes a processor circuit in communication with an extraluminal imaging device and an intraluminal catheter or guidewire, the processor circuit receiving a first extraluminal image acquired by the extraluminal imaging device, the first extraluminal image being acquired without contrast within the body cavity, and receiving a plurality of second extraluminal images acquired by the extraluminal imaging device during movement of the intraluminal catheter or guidewire within the patient's body cavity, the plurality of second extraluminal images being acquired without contrast within the body cavity, and receiving a plurality of second extraluminal images acquired by the extraluminal imaging device during movement of the intraluminal catheter or guidewire within the patient's body cavity, the plurality of second extraluminal images being acquired without contrast within the body cavity. receiving a plurality of endoluminal data points acquired by the imaging system; positionally synchronizing the plurality of endoluminal data points to the first extraluminal image based on the plurality of second extraluminal images, where the positional synchronization is performed without the extraluminal images acquired with contrast agent in the body cavity; and outputting a first screen display on a display in communication with the processor circuit, the first screen display including the first extraluminal image, a visual representation of an endoluminal data point of the plurality of endoluminal data points, and a marking superimposed on the extraluminal image at a corresponding location of the endoluminal data point.

[0012] In one exemplary aspect, a system is provided that includes an intravascular imaging catheter, an x-ray imaging device, and a processor circuit in communication with the intravascular imaging device, the processor circuit receiving a first x-ray image acquired by the x-ray imaging device, receiving a plurality of second x-ray images acquired by the x-ray imaging device during movement of the intravascular imaging catheter within a patient's blood vessel, the plurality of second x-ray images being acquired without a contrast agent in the blood vessel, receiving the plurality of intravascular images acquired by the intravascular imaging catheter during movement, and determining a curve representing at least one of a shape or a position of the blood vessel based on the plurality of second x-ray images. the first x-ray image was acquired without an intravascular contrast agent; determining whether the first x-ray image was acquired without an intravascular contrast agent; in response to determining that the first x-ray image was acquired without an intravascular contrast agent, assigning the curve as a centerline of the body cavity in the first x-ray image without identifying the vessel in the first x-ray image and without identifying the centerline in the first x-ray image; positionally synchronizing the plurality of intravascular images to positions along the curve; and outputting a first screen representation on a display in communication with the processor circuit, the first screen representation including the first x-ray image, an intravascular image of the plurality of intravascular images, and a marking superimposed on the extraluminal image at a corresponding position on the intravascular image.

[0013]

[0013] Further aspects, features, and advantages of the present disclosure will become apparent from the following detailed description. [Brief description of the drawings]

[0014]

[0014] Illustrative embodiments of the present disclosure will now be described in conjunction with the accompanying drawings, in which: [Figure 1]

[0015] FIG. 1 shows a schematic diagram of an intracavitary imaging and X-ray system according to an embodiment of the present disclosure. [Diagram 2]

[0016] FIG. 2 shows a schematic top view of an ultrasound imaging assembly in a flat configuration according to an embodiment of the present disclosure. [Diagram 3]

[0017] FIG. 3 is a schematic side view of the ultrasound imaging assembly of FIG. 2 in a wrapped configuration about a support member according to an embodiment of the present disclosure. [Figure 4]

[0018] FIG. 4 illustrates a schematic cross-sectional view of the ultrasound imaging assembly shown in FIG. 3 according to an embodiment of the present disclosure. [Diagram 5]

[0019] FIG. 5 is a schematic diagram of a processor circuit according to an embodiment of the disclosure. [Figure 6]

[0020] FIG. 6 is a schematic diagram of an extraluminal image showing the path of an endoluminal device, according to an embodiment of the present disclosure. [Figure 7]

[0021] FIG. 7 is a schematic diagram of a relationship between an extraluminal image and a set of locations according to an embodiment of the present disclosure. [Figure 8]

[0022] FIG. 8 is a schematic diagram of a trajectory-based shape of an intraluminal device, according to an embodiment of the present disclosure. [Figure 9]

[0023] FIG. 9 is a schematic illustration of a motion-based shape footprint line of an endoluminal device according to an embodiment of the present disclosure. [Figure 10]

[0024] FIG. 10 is a schematic diagram of the relationship between intraluminal ultrasound data, an extraluminal image, and a footprint line of an intraluminal device, according to an embodiment of the present disclosure. [Figure 11]

[0025] FIG. 11 is a schematic diagram of the relationship between footprint lines and position-synchronized endoluminal data with a calculated centerline superimposed on an extraluminal image according to an embodiment of the present disclosure. [Figure 12]

[0026] FIG. 12 is a schematic diagram of a graphical user interface according to an embodiment of the present disclosure. [Figure 13]

[0027] FIG. 13 is a schematic diagram of a graphical user interface according to an embodiment of the present disclosure. [Figure 14]

[0028] FIG. 14 is a schematic diagram of a graphical user interface according to an embodiment of the present disclosure. [Figure 15]

[0029] FIG. 15 is a schematic diagram of a graphical user interface according to an embodiment of the present disclosure. [Figure 16]

[0030] FIG. 16 is a flow diagram of a method for positionally synchronizing endoluminal data to non-contrast x-ray image frames according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015]

[0031] In order to facilitate the understanding of the principles of the present disclosure, reference will be made to the illustrated embodiments and specific terms will be used to describe them. However, it will be understood that this is not intended to limit the scope of the present disclosure. Any changes and modifications to the apparatus, system, method, and further applications of the principles of the present disclosure described herein, as would normally occur to a person skilled in the art to which the present disclosure pertains, are fully considered and included in the present disclosure. In particular, it is fully considered that the features, components, and / or steps described with respect to one embodiment may be combined with the features, components, and / or steps described with respect to other embodiments of the present disclosure. However, for the sake of brevity, such multiple combinations of iterations will not be described separately.

[0016]

[0032] Some inventive aspects of the present disclosure are directed to optimizing workflow, user interface, and algorithmic aspects related to positional synchronization of endoluminal data and extraluminal images without the use of contrast agents.

[0017]

[0033] FIG. 1 illustrates a schematic diagram of an endoluminal imaging and x-ray system 100 according to an aspect of the present disclosure. In some embodiments, the endoluminal imaging and x-ray system 100 includes two separate systems, an endoluminal sensing system 101 and an extraluminal imaging system 151, or may be a combination of these two systems. The endoluminal sensing system 101 acquires medical data related to a patient's body while the endoluminal device 102 is disposed within the patient's body. For example, the endoluminal sensing system 101 can control the endoluminal device 102 to acquire endoluminal images of the inside of the patient's body while the endoluminal device 102 is within the patient's body. The extraluminal imaging system 151 acquires medical data related to a patient's body while the extraluminal imaging device 152 is disposed outside the patient's body. For example, the extraluminal imaging system 151 can control the endoluminal imaging device 152 to acquire extraluminal images of the inside of the patient's body while the extraluminal imaging device 152 is outside the patient's body.

[0018]

[0034] The endoluminal imaging system 101 may communicate with the extraluminal imaging system 151 via any suitable component. Such communication may be established via wired cables, via wireless signals, or by other means. Additionally, the endoluminal imaging system 101 may communicate continuously or intermittently with the X-ray system 151. For example, the two systems may communicate temporarily via wired cables, via wireless communication, or via other suitable means before, after, or at some point during the examination. Additionally, the endoluminal system 101 may receive data from the X-ray imaging system 151, such as X-ray images, annotated X-ray images, metrics calculated using the X-ray imaging system 151, information regarding the date and time of the examination, the type and / or severity of the patient's condition or diagnosis, medical history or other patient information, or any suitable data or information. The X-ray imaging system 151 may also receive any of these data from the endoluminal imaging system 101. In some embodiments, the endoluminal imaging system 101 and the X-ray imaging system 151 may communicate with the same control system 130, as shown in FIG. 1. In this embodiment, both systems may communicate with the same illustrated display 132 , processor 134 , and communication interface 140 , as well as other components implemented within the control system 130 .

[0019]

[0035] In some embodiments, the system 100 may not include a control system 130 in communication with the intracavity imaging system 101 and the X-ray imaging system 151. Instead, the system 100 may include two separate control systems. For example, one control system may be in communication with or part of the intracavity imaging system 101, and another separate control system may be in communication with or part of the X-ray imaging system 151. In this embodiment, the separate control systems for both the intracavity imaging system 101 and the X-ray imaging system 151 may be similar to the control system 130. For example, each control system may include various components or systems, such as a communication interface, a processor, and / or a display. In this embodiment, the control system of the intracavity imaging system 101 may perform any or all of the position synchronization steps described in this disclosure. Alternatively, the control system of the X-ray imaging system 151 may perform the position synchronization steps described.

[0020]

[0036] The intracavity imaging system 101 may be an ultrasound imaging system. In some cases, the intracavity imaging system 101 may be an IVUS (intravascular ultrasound) imaging system. The intracavity imaging system 101 may include an intracavity imaging device 102, such as a catheter, guidewire, or guide catheter, in communication with a control system 130. The control system 130 may include components such as a display 132, a processor 134, and a communication interface 140. The intracavity imaging device 102 may be an ultrasound imaging device. In some cases, the device 102 may be an IVUS imaging device, such as a solid-state IVUS device. In some embodiments, the user input device and the display 132 may be integrated in one housing or may be separate devices.

[0021]

[0037] Broadly speaking, the IVUS device 102 emits ultrasonic energy from a transducer array 124 included in a scanner assembly (also referred to as an IVUS imaging assembly) mounted near the distal end of the catheter device. The ultrasonic energy is reflected by tissue structures in a medium, such as a blood vessel 120 or other lumen, surrounding the scanner assembly 110, and ultrasonic echo signals are received by the transducer array 124. In this regard, the device 102 may have a size, shape, or other configuration suitable for placement within a patient's cavity. The communication interface 140 transfers the received echo signals to a processor 134 of the control system 130, where an ultrasonic image (including flow information in some embodiments) is reconstructed and displayed on the display 132. The control system 130, including the processor 134, may be operable to facilitate the features of the IVUS imaging system 101 described herein. For example, the processor 134 may execute computer readable instructions stored on a non-transitory tangible computer readable medium.

[0022]

[0038] The communication interface 140 facilitates signal communication between the processing system 130 and the scanner assembly 110 included in the IVUS device 102. This communication includes (1) providing commands to an integrated circuit controller chip included in the scanner assembly 110 to select a particular transducer array element or acoustic element to be used for transmission and reception, (2) providing a transmit trigger signal to an integrated circuit controller chip included in the scanner assembly 110 to activate a transmitter circuit to generate an electrical pulse that excites the selected transducer array element, and / or (3) receiving an amplified echo signal received from the selected transducer array element via an amplifier included in the integrated circuit controller chip of the scanner assembly 110. In some embodiments, the communication interface 140 performs pre-processing of the echo data before transferring the data to the processor 134. In an example of such an embodiment, the communication interface 140 performs amplification, filtering, and / or summarization of the data. In one embodiment, the communication interface 140 also provides high voltage and low voltage DC power to support operation of the device 102 including the circuitry within the scanner assembly 110.

[0023]

[0039] The processor 134 receives echo data from the scanner assembly 110 via the communication interface 140 and processes the data to reconstruct an image of tissue structures within the medium surrounding the scanner assembly 110. The processor 134 outputs the image data such that an image of the lumen 120, such as a cross-sectional image of the blood vessel 120, is displayed on the display 132. The lumen 120 may represent a natural or artificial, fluid-filled or surrounded structure. The lumen 120 may be within a patient's body. The lumen 120 may be a blood vessel, such as an artery or vein, of the patient's vascular system, including, for example, the cardiovascular system, the peripheral vascular system, the neurovascular system, the renal vascular system, and / or any other suitable lumen within the body. For example, device 102 may be used to inspect any number of anatomical locations and tissue types, including, but not limited to, organs including the liver, heart, kidneys, gallbladder, pancreas, lungs; ducts; intestines; nervous system structures including the brain, dural sac, spinal cord, and peripheral nerves; urinary tract, blood valves, ventricles, other parts of the heart, and / or other systems of the body. In addition to natural structures, device 102 may be used to inspect artificial structures, such as, but not limited to, heart valves, stents, shunts, filters, and other devices.

[0024]

[0040] In some embodiments, the IVUS device includes some features similar to those of conventional solid-state IVUS catheters, such as the EagleEye® catheter, Visions PV.014P RX catheter, Visions PV.018 catheter, Visions PV.035, and Pioneer Plus catheters, each available from Koninklijke Philips NV, and those disclosed in U.S. Pat. No. 7,846,101, which is incorporated by reference in its entirety. For example, the IVUS device 102 includes a scanner assembly 110 near the distal end of the device 102 and a transmission wire bundle 112 extending along the longitudinal body of the device 102. The transmission wire bundle or cable 112 can include multiple conductors, for example, 1, 2, 3, 4, 5, 6, 7, or more conductors. It will be appreciated that any suitable gauge of wire can be used for the conductors. In one embodiment, the cable 112 can include a four-conductor transmission line configuration, for example, with 41 AWG gauge wire. In one embodiment, the cable 112 may include a seven conductor transmission line configuration utilizing, for example, 44 AWG gauge wire, although in some embodiments 43 AWG gauge wire may be used.

[0025]

[0041] The transmission line bundle 112 terminates in a patient interface module (PIM) connector 114 at the proximal end of the device 102. The PIM connector 114 electrically couples the transmission line bundle 112 to a communication interface 140 and physically couples the IVUS device 102 to the communication interface 140. In some embodiments, the communication interface 140 may be a PIM. In one embodiment, the IVUS device 102 further includes a guidewire exit port 116. Thus, in some cases, the IVUS device 102 is a rapid exchange catheter. The guidewire exit port 116 allows a guidewire 118 to be inserted toward the distal end for guiding the device 102 through the blood vessel 120.

[0026]

[0042] In some embodiments, the intraluminal imaging device 102 can acquire intravascular images of any suitable imaging modality, such as optical coherence tomography (OCT) and intravascular photoacoustic (IVPA).

[0027]

[0043] In some embodiments, the intraluminal device 102 is a pressure sensing device (e.g., a pressure sensing guidewire) that acquires intraluminal (e.g., intravascular) pressure data, and the intraluminal system 101 is an intravascular pressure sensing system that determines a pressure ratio, such as fractional flow reserve (FFR), instantaneous wave-free ratio (iFR), and / or other suitable ratio between distal pressure and proximal / aortic pressure (Pd / Pa) based on the pressure data. In some embodiments, the intraluminal device 102 is a flow sensing device (e.g., a flow sensing guidewire) that acquires intraluminal (e.g., intravascular) flow data, and the intraluminal system 101 is an intravascular flow sensing system that determines flow-related values, such as coronary flow reserve (CFR), flow velocity, and flow rate, based on the pressure data.

[0028]

[0044] The X-ray imaging system 151 may include an X-ray imaging apparatus or device 152 configured to perform imaging techniques such as X-ray imaging, angiography, fluoroscopy, radiography, and venography. The X-ray imaging system 151 may generate a single X-ray image (e.g., an angiogram or venogram) or multiple (e.g., two or more) X-ray images (e.g., video and / or fluoroscopic image streams) based on X-ray image data collected by the X-ray device 152. The X-ray imaging device 152 may be of any suitable type, for example, a fixed X-ray system such as a fixed C-arm X-ray device, a mobile C-arm X-ray device, a straight arm X-ray device, or a U-arm device. The X-ray imaging device 152 may be any suitable mobile device. The X-ray imaging device 152 may also be in communication with the control system 130. In some embodiments, the X-ray system 151 may include a digital radiography device or other suitable device.

[0029]

[0045] 1 includes an X-ray source 160 and an X-ray detector 170 that includes an input screen 174. The X-ray source 160 and the detector 170 may be located at a distance from each other. A patient's anatomy or object 180 may be located between the X-ray source 160 and the X-ray detector 170. For example, a patient's anatomy (including blood vessels 120) may be located between the X-ray source 160 and the X-ray detector 170.

[0030]

[0046] The X-ray source 160 may include an X-ray tube configured to generate X-rays. Some embodiments of the X-ray source 160 may include one or more vacuum tubes including a cathode connected to the negative lead of a high voltage power supply and an anode connected to the positive lead of the same power supply. The cathode of the X-ray source 160 may further include a filament. The filament may be of any suitable type or formed from any suitable material, such as tungsten or rhenium tungsten, and may be disposed within a recessed region of the cathode. One function of the cathode may be to emit electrons from the high voltage power supply and focus them into a well-defined beam directed toward the anode. The anode may also be formed from any suitable material and may be configured to generate X-rays from the electrons emitted from the cathode. Additionally, the anode may dissipate heat generated in the process of generating the X-rays. The anode may be shaped as a disk with an oblique angle and may be rotated by an electric motor in some embodiments. The cathode and anode of the X-ray source 160 may be housed within an airtight enclosure, also referred to as an envelope.

[0031]

[0047] In some embodiments, the x-ray source 160 may include a radiation object focal point that affects the visibility of the image. The radiation object focal point may be selected by a user or manufacturer of the system 100 based on blur, visibility, heat dissipation capabilities, or other characteristics. In some embodiments, an operator or user of the system 100 may switch between multiple different radiation object focal points provided in a point-of-care setting.

[0032]

[0048] The detector 170 may be configured to acquire an X-ray image and may include an 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 then expose a film. The input screen 174 may be used to convert the X-ray energy to light in embodiments where the film may be more sensitive to light than to X-rays. A number of different types of intensifying screens within the image intensifier may be selected depending on the area of ​​the patient being imaged, the requirements for image detail and / or patient exposure, or other factors. The intensifying screens may be formed of any suitable material, such as barium lead sulfate, barium strontium sulfate, barium fluoride chloride, yttrium oxysulfide, or other suitable material. The input screen 374 may be a fluorescent screen, or a film disposed directly adjacent to the fluorescent screen. In some embodiments, the input screen 374 may also include a protective screen to protect circuitry or components within the detector 370 from the surrounding environment. In some embodiments, the X-ray detector 170 may include a flat panel detector (FPD). The detector 170 may be an indirect conversion type FPD or a direct conversion type FPD. The detector 170 may also include a charge-coupled device (CCD). The X-ray detector 370 may also be referred to as an X-ray sensor.

[0033]

[0049] Object 180 may be any object suitable for being imaged. In an exemplary embodiment, the object may be an anatomical structure of a patient. More specifically, the anatomical structure imaged may include the patient's chest, abdomen, pelvic region, neck, legs, head, feet, areas including the cardiovascular system, or areas including the peripheral vascular system, and may include various anatomical structures, such as, but not limited to, organs, tissues, blood vessels and blood, gases, or other anatomical structures or objects. In other embodiments, the object may be or include an artificial structure.

[0034]

[0050] In some embodiments, the X-ray imaging system 151 may be configured to acquire X-ray images without a contrast agent. In some embodiments, the X-ray imaging system 151 may be configured to acquire X-ray images (e.g., angiograms or venograms) with a contrast agent. In such embodiments, a contrast agent or X-ray dye may be introduced into the patient's anatomy prior to imaging. A contrast agent may also be referred to as a radiological contrast agent, a contrast substance, a contrast dye, or a contrast medium. A contrast dye may be any suitable material, chemical, or compound and may be a liquid, powder, paste, tablet, or other suitable form. For example, a contrast dye may be an iodine-based compound, a barium sulfate-based compound, a gadolinium-based compound, or other suitable compound. A contrast agent may be used to enhance the visibility of bodily fluids or structures within the patient's anatomy. A contrast agent may absorb external X-rays and reduce exposure at the X-ray detector 170.

[0035]

[0051] In some embodiments, the extraluminal imaging system 151 may be any suitable extraluminal imaging device, such as a computed tomography (CT) or magnetic resonance imaging (MRI).

[0036]

[0052] When control system 130 communicates with X-ray system 151, communication interface 140 facilitates communication of signals between control system 130 and X-ray device 152. This communication includes providing control commands to X-ray source 160 and / or X-ray detector 170 of X-ray device 152 and receiving data from X-ray device 152. In some embodiments, communication interface 140 performs pre-processing of the X-ray data before transferring the X-ray data to processor 134. In an example of such an embodiment, communication interface 140 may perform data amplification, filtering, and / or aggregation. In one embodiment, communication interface 140 also provides high voltage and low voltage DC power to support operation of device 152, including circuitry therein.

[0037]

[0053] The processor 134 receives the x-ray data from the x-ray device 152 via the communication interface 140 and processes the data to reconstruct an image of the anatomical structure to be imaged. The processor 134 outputs the image data so that the image is displayed on the display 132. In embodiments in which a contrast agent is introduced into the patient's anatomy and a venogram is generated, the particular region of interest imaged may be one or more blood vessels or other sections or portions of the vascular system of the human body. The contrast agent may identify natural and / or man-made structures filled with fluid, and may be, for example, arteries or veins of the patient's vascular system, such as the cardiovascular system, peripheral vascular system, neurovascular system, renal vascular system, and / or any other suitable lumen in the body. For example, the x-ray device 152 may be used to inspect any number of anatomical locations and tissue types, including, but not limited to, all of the organs, fluids, or other structures or portions of the anatomy described above. In addition to natural structures, the x-ray device 152 may also be used to inspect man-made structures, such as those described above.

[0038]

[0054] The processor 134 may be configured to receive x-ray images stored by the x-ray imaging device 152 during a clinical procedure. The images may be further enhanced with other information, such as medical history, patient records, IVUS imaging, pre-operative ultrasound imaging, pre-operative CT, or other suitable data.

[0039]

[0055] FIG. 2 illustrates a schematic top view of an ultrasound imaging assembly 110 in a flat configuration according to an embodiment of the disclosure. The flexible assembly 110 includes a transducer array 124 formed in a transducer region 204 and a plurality of 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 die 206 is mounted on a flexible substrate 214 on which the transducer elements 212 are pre-integrated. The flexible substrate 214 is illustrated in FIG. 2 in a flat configuration. Although six control logic dies 206 are illustrated in FIG. 2, any number of control logic dies 206 can be used. For example, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, or more control logic dies 206 can be used.

[0040]

[0056] The flexible substrate 214 on which the transducer control logic die 206 and the transducer elements 212 are attached provides structural support and interconnects for electrical coupling. The flexible substrate 214 may be configured to include a film layer of flexible polyimide material, such as KAPTON (DuPont). Other suitable materials include polyester, polyimide, polyethylene naphthalate, or polyetherimide films, liquid crystal polymers, other flexible printed semiconductor substrates, and products such as Upilex (registered trademark of Ube Industries, Ltd.) and TEFLON (registered trademark of EI du Pont). In the flat configuration shown in FIG. 2, the flexible substrate 214 has a generally rectangular shape. As shown and described herein, the flexible substrate 214 is configured to be optionally wrapped around the support member 230 (FIG. 3). Thus, the thickness of the film layer of the flexible substrate 214 is generally related to the curvature of the flexible assembly 110 after final assembly. In some embodiments, the film layer is between 5 μm and 100 μm, and in some specific embodiments, between 5 μm and 25.1 μm, for example, 6 μm.

[0041]

[0057] The set of transducer control logic die 206 is a non-limiting example of a control circuit. The transducer region 204 is disposed on a distal portion 221 of the flexible substrate 214. The control region 208 is disposed on 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. The dimensions (e.g., lengths 225, 227, 229) of the transducer region 204, the control region 208, and the transition region 210 may vary from embodiment to embodiment. In some embodiments, the lengths 225, 227, 229 may be substantially similar, or the length 227 of the transition region 210 may be shorter than the lengths 225 and 229, and the length 227 of the transition region 210 may be longer than the lengths 225, 229 of the transducer region and the controller region, respectively.

[0042]

[0058] The control logic die 206 are not necessarily homogeneous. In some embodiments, a single controller is designated as the master control logic die 206A and includes a communication interface for the cable 112 between the processing system (e.g., the processing system 106 and the flexible assembly 110). Thus, the master control circuitry may include control logic to decode control signals received over the cable 112, send control responses over the cable 112, amplify echo signals, and / or send echo signals over the cable 112. The remaining controller is a slave controller 206B. The slave controller 206B drives multiple transducer elements 512 arranged on the transducer element 212. The master controller 206A may include control logic for selecting transducer elements 212 to transmit ultrasonic signals and receive echoes. In the illustrated embodiment, the master controller 206A does not directly control the transducer elements 212. In other embodiments, the master controller 206A drives the same number of transducer elements 212 as the slave controllers 206B, or drives a set of fewer transducer elements 212 compared to the slave controllers 206B. In an exemplary embodiment, a single master controller 206A and eight slave controllers 206B are provided, with eight transducers assigned to each slave controller 206B.

[0043]

[0059] To electrically interconnect the control logic die 206 and the transducer elements 212, in one embodiment, the flexible substrate 214 includes conductive traces 216 formed in the film layer that transmit signals between the control logic die 206 and the transducer elements 212. In particular, the conductive traces 216 that provide communication between the control logic die 206 and the transducer elements 212 extend along the flexible substrate 214 in the transition region 210. In some cases, the conductive traces 216 may also facilitate electrical communication between the master controller 206A and the slave controller 206B. The conductive traces 216 may also provide a set of conductive pads that contact the conductors 218 of the 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 formed on the flexible substrate 214 by methods such as sputtering, plating, and etching. In one embodiment, the flexible substrate 214 includes a chrome adhesion layer. The width and thickness of the conductive traces 216 are selected to provide suitable conductivity and resilience when the flexible substrate 214 is rolled. In this regard, an exemplary thickness range for the conductive traces 216 and / or conductive pads is 1-5 μm. For example, in one embodiment, 5 μm conductive traces 216 are separated by 5 μm spacing. The width of the conductive traces 216 on the flexible substrate may be further determined by the width of the conductors 218 that are coupled to the traces or pads.

[0044]

[0060] In some embodiments, the flexible substrate 214 can include a conductor interface 220. The conductor interface 220 can be located at a location on the flexible substrate 214 where the conductors 218 of the cable 112 are coupled to the flexible substrate 214. For example, 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 a tab extending from the body of the flexible substrate 214. In this regard, the body of the flexible substrate 214 can collectively refer to the transducer region 204, the controller region 208, and the transition region 210. In the illustrated embodiment, the conductor interface 220 extends from the proximal portion 222 of the flexible substrate 214. In other embodiments, the conductor interface 220 can be located in other portions of the flexible substrate 214, such as the distal portion 221, or the flexible substrate 214 can lack a conductor interface 220. The dimensions of the tab or conductor interface 220, e.g., width 224, can be smaller than the dimensions of the body of the flexible substrate 214, e.g., width 226. In some embodiments, the substrate forming the conductor interface 220 is made of the same material as the flexible substrate 214 and / or is similarly flexible. In other embodiments, the conductor interface 220 is made of a different material and / or is more rigid than the flexible substrate 214. For example, the conductor interface 220 may be formed of a plastic, thermoplastic, polymer, rigid polymer, or the like, such as polyoxymethylene (e.g., DELRIN®), polyetheretherketone (PEEK), nylon, liquid crystal polymer (LCP), and / or other suitable materials.

[0045]

[0061] FIG. 3 is a schematic side view of the ultrasound imaging assembly 102 of FIG. 2 in a configuration wound around a support member according to aspects of the present disclosure. FIG. 3 shows a perspective view of the scanner assembly 110 in a wound configuration. In some cases, the flexible base 214 transitions from a flat configuration (FIG. 2) to a wound or more cylindrical configuration (FIG. 3). For example, in some embodiments, techniques disclosed in one or more of U.S. Patent No. 6,776,763, entitled "ULTRASONIC TRANSDUCER ARRAY AND METHOD OF MANUFACTURING THE SAME," and U.S. Patent No. 7,226,417, entitled "HIGH RESOLUTION INTRAVASCULAR ULTRASOUND SENSING ASSEMBLY HAVING A FLEXIBLE SUBSTRATE," each of which is incorporated herein by reference in its entirety, are utilized.

[0046]

[0062] Depending on the application and embodiment of the invention, the transducer elements 212 may be piezoelectric transducers, single crystal transducers, or PZT (lead zirconate titanate) transducers. In other embodiments, the transducer elements of the transducer array 124 may be bending transducers, piezoelectric micromachined ultrasonic transducers (PMUTs), capacitive micromachined ultrasonic transducers (CMUTs), or other suitable types of transducer elements. In such embodiments, the transducer elements 212 may be comprised of elongated semiconductor material or other suitable material that allows for micromachining or similar methods of placing extremely small elements or circuits on a substrate.

[0047]

[0063] In some embodiments, the transducer elements 212 and the controller 206 may be arranged in an annular configuration, such as a circular or polygonal configuration, around the long axis 250 of the support member 230. It should be understood that the long axis 250 of the support member 230 may also be referred to as the long axis of the scanner assembly 110, the flexible elongate member 121, or the device 102. For example, the cross-sectional shape of the imaging assembly 110 at the transducer elements 212 and / or the controller 206 may be circular or polygonal. Any suitable annular polygonal shape may be implemented based on, for example, the number of controllers or transducers, the flexibility of the controllers / transducers, etc. Examples include pentagons, hexagons, heptagons, octagons, nonagons, decagons, etc. In some examples, the transducer controller 206 may be used to control the ultrasound transducers 512 of the ultrasound transducer elements 212 to obtain imaging data related to the blood vessel 120.

[0048]

[0064] The support member 230 may be referred to as a unibody in some cases. The support member 230 may be formed from a metallic material, such as stainless steel, or may be formed from a non-metallic material, such as a plastic or polymer, as described in U.S. Provisional Application No. 61 / 985,220, filed April 28, 2014, entitled "Pre-Doped Solid Substrate for Intravascular Devices," which is incorporated herein by reference in its entirety. In some embodiments, the support member 230 may be formed from 303 stainless steel. The support member 230 may be a ferrule having a distal flange or portion 232 and a proximal flange or portion 234. The support member 230 may have a tubular shape and may define a lumen 236 extending lengthwise therethrough. The lumen 236 may be sized and shaped to accommodate the guidewire 118. The support member 230 may be manufactured using any suitable process. For example, the support member 230 may be mechanically and / or electrochemically machined or laser machined, e.g., by removing material from a blank to form the support member 230, or may be molded, such as by an injection molding process or a micro-injection molding process.

[0049]

[0065] 4, a schematic cross-sectional side view of a distal portion of an intracavity imaging device 102 including a flexible substrate 214 and a support member 230 is shown, according to an aspect of the present disclosure. A lumen 236 may be in communication with the inlet / outlet port 116 and is sized and shaped to receive a guidewire 118 (FIG. 1). In some embodiments, the support member 230 may be integrally formed as a unitary structure, while in other embodiments, the support member 230 may be formed from a number of different components, such as ferrules and stands 242, 243, and 244, fixedly coupled to one another. In some cases, the support member 230 and / or one or more components thereof may be fully integrated with the inner member 256. In some cases, the inner member 256 and the support member 230 may be integrally joined, such as in the case of a polymeric support member.

[0050]

[0066] The distal, central, and proximal portions of the support member 230 are provided with vertically extending stands 242, 243, and 244, respectively. The stands 242, 243, and 244 lift and support the distal, central, and proximal portions of the flexible substrate 214. In this regard, a portion of the flexible substrate 214, such as the transducer portion 204 (or transducer region 204), may be spaced apart from the central body portion of the support member 230 that extends between the stands 242, 243, and 244. The stands 242, 243, and 244 may have the same outer diameter or different outer diameters. For example, the distal stand 242 may have a larger or smaller outer diameter than the central stand 243 and / or the proximal stand 244, and may also have special features for rotational alignment and control chip placement and connection.

[0051]

[0067] To improve acoustic performance, 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 may be introduced between the flexible substrate 214 and the support member 230 via the channels 235 in the stand 242 or via additional recesses, which will be described in more detail below. The backing material 246 may serve to attenuate ultrasonic energy emitted from the transducer array 212 and propagating in an undesired inward direction.

[0052]

[0068] The cavity between the circuit controller chip 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 (e.g., epoxy) that provides structural support to the circuit controller chip 206 and / or the flexible substrate 214. The underfill 247 may be any suitable material.

[0053]

[0069] In some embodiments, the central body portion of the support member may include a recess that allows fluid communication between the lumen of the unibody and the cavity between the flexible substrate 214 and the support member 230. An acoustic backing material 246 and / or an underfill material 247 may be introduced through the cavity (prior to threading the inner member 256 through the lumen of the unibody during the assembly process). In some embodiments, suction may be applied through the channel 235 of one of the stands 242, 244 and to the other suitable recess while liquid backing material 246 is provided between the flexible substrate 214 and the support member 230 through the channel 235 of the other of the stands 242, 244 and to the other suitable recess. The backing material may be cured to solidify and solidify. In various embodiments, the support member 230 may include more than the three stands 242, 243, and 244, may include only one or two of the stands 242, 243, 244, or may include none of the stands. In this regard, the support member 230 can have an enlarged diameter distal portion 262 and / or an enlarged diameter proximal portion 264 sized and shaped to lift and support a distal portion and / or a proximal portion of the flexible substrate 214 .

[0054]

[0070] The support member 230 may be generally cylindrical in some embodiments. Other shapes of the support member 230 are contemplated, including geometric, non-geometric, symmetrical, and asymmetrical cross-sectional shapes. As used herein, the term shape of the support member 230 may refer to the cross-sectional shape of the support member 230. In other embodiments, the support member 230 may have different shapes from section to section. For example, the proximal section 264 may have a larger outer diameter than the distal section 262, or the central section extending between the distal section 262 and the proximal section 264. In some embodiments, the inner diameter of the support member 230 (e.g., the diameter of the lumen 236) may increase or decrease as the outer diameter changes. In other embodiments, the inner diameter of the support member 230 does not change as the outer diameter changes.

[0055]

[0071] The proximal inner member 256 and the 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 may comprise flexible elongate members. The proximal inner member 256 may be housed within the proximal flange 234. The proximal outer member 254 abuts and contacts the proximal end of the flexible substrate 214. The distal tip member 252 is coupled to the distal portion 262 of the support member 230. For example, the distal portion 252 is disposed about the distal flange 232. The tip member 252 may abut and contact the distal end of the flexible substrate 214 and the stand 242. In other embodiments, the proximal end of the tip member 252 may be housed within the distal end of the flexible substrate 214 in a rolled configuration. In some embodiments, a gap may exist between the flexible substrate 214 and the tip member 252. The distal member 252 may be the distal-most component of the intracavity imaging device 102. The distal tip member 252 may be a flexible polymer component that defines the distal-most end of the imaging device 102. The distal tip member 252 may further define a lumen that communicates with the lumen 236 defined by the support member 230. The guidewire 118 may pass through the lumen 236 and the lumen defined by the tip member 252.

[0056]

[0072] One or more adhesives may be disposed between various components located at a distal portion of the intracavity imaging device 102. For example, 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 may be coupled to one another via an adhesive. In other words, the adhesive may contact components such as, for example, 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.

[0057]

[0073] FIG. 5 is a schematic diagram of a processor circuit 510 according to an embodiment of the disclosure. The processor circuit 510 may be implemented in the control system 130, the intracavity imaging system 101, and / or the X-ray imaging system 151 of FIG. 1, or in other suitable locations. In an example, the processor circuit 510 may communicate with the intracavity imaging device 102, the X-ray imaging system 152, and the display 132 in the system 100. The processor circuit 510 may include a processor 134 and / or a communication interface 140 (FIG. 1). The one or more processor circuits 510 are configured to perform the operations described herein. As shown, the processor circuit 510 may include a processor 560, a memory 564, and a communication module 568. These elements may communicate with each other directly or indirectly, for example, via one or more buses.

[0058]

[0074] Processor 560 may include a CPU, GPU, DSP, application-specific integrated circuit (ASIC), controller, FPGA, other hardware device, firmware device, or any combination thereof configured to perform the operations described herein. Processor 560 may also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, multiple microprocessors, one or more microprocessors in combination with a DSP core, or other similar configurations.

[0059]

[0075] The memory 564 may include cache memory (e.g., 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 devices, hard disk drives, other forms of volatile and non-volatile memory, or a combination of various types of memory. In one example, 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). The 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. For example, the terms "instructions" and "code" may refer to one or more programs, routines, subroutines, functions, procedures, etc. "Instructions" and "code" may include a single computer-readable statement or multiple computer-readable statements.

[0060]

[0076] The communications module 568 may include any electronic and / or logical circuitry that facilitates direct or indirect data communication between the processor circuit 510, the probe 110, and / or the display 132. In this regard, the communications module 568 may be an input / output (I / O) device. In some cases, the communications 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).

[0061]

[0077] 6 is a schematic diagram of an X-ray image 600 according to an embodiment of the present disclosure. As mentioned above, one of the objectives of the present disclosure may be to perform a position synchronization procedure between endoluminal data, such as IVUS data or physiological data, and extraluminal images without introducing contrast into the patient.

[0062]

[0078] Broadly speaking, a position synchronization procedure involves performing an endovascular procedure and an extraluminal imaging procedure simultaneously. For example, a patient's anatomy may be positioned within an imaging field of an extraluminal imaging device. The extraluminal imaging device may acquire an extraluminal image of the patient. While acquiring the extraluminal image, a physician may position an endovascular device, such as an IVUS catheter, within the patient's blood vessel within the field of view of the extraluminal imaging device. As the physician passes the IVUS catheter into the vessel, a radiopaque portion of the IVUS device may be observed within an X-ray image. In this regard, as the IVUS device moves within the vessel, the position of the device may differ in each received X-ray image. As the IVUS device moves, an IVUS image may be acquired. As the IVUS image and the X-ray image are acquired simultaneously, the system may correspond the IVUS image to the current position of the IVUS device as observed within the X-ray image. Multiple positions of the IVUS device during this procedure may be stored as a series of coordinates and used to determine a path of movement of the device as it moves within the vessel. Each position along the generated path may correspond to an IVUS image. In many position-synchronized procedures, this pathway is overlaid on an additional x-ray image with contrast. To obtain this x-ray image, the physician may administer a contrast agent to the patient's vasculature. This contrast agent may allow blood vessels to be seen in the x-ray image. Without the administration of contrast, blood vessels may not be seen in a normal x-ray image. The pathway generated based on the location of the IVUS device may be overlaid on the x-ray image with contrast. Alternatively, a centerline based on the location of the blood vessels in multiple x-ray images with contrast may be used in some cases to ensure that the IVUS pathway matches the correct vessels and that the positional synchronization of the IVUS data with the x-ray images with contrast (e.g., angiograms) is accurate.

[0063]

[0079] Although the above examples describe an intravascular ultrasound device, the same principles may be applied to any suitable intraluminal procedure. For example, other intraluminal data, such as physiological data including blood pressure data (e.g., FFR data, iFR data, or other pressure data) or blood flow data, may be acquired in a similar manner and positionally synchronized to the extraluminal images.

[0064]

[0080] In some cases, some patients may be sensitive to the contrast agent used to image blood vessels in the X-ray image. In particular, patients with chronic kidney disease (CKD) may be more likely to develop complications from the use of contrast agents. For example, they may be at risk of contrast-induced nephropathy (CIN) if contrast agents are introduced into the patient's vasculature. The present invention preferably provides a method for performing the position synchronization step without the use of contrast agents or with a significantly reduced dose of contrast agents to represent the roadmap image. This provides the advantage of dramatically reducing the risk of patient complications associated with exposure to contrast agents. This may allow patients to be released from the position synchronization procedure sooner and reduce the procedure time of the procedure itself, allowing more patients to be discharged the same day, even after highly complex interventions.

[0065]

[0081] The extraluminal image 600 shown in FIG. 6 may display a view of the patient's anatomy. The image 600 may be an x-ray image acquired without introducing contrast into the vasculature. This may be evident from the lack of blood vessels observed in the image 600. As an example, a path 610 is superimposed on the image 600. The path 610 may correspond to a blood vessel in the anatomy. In particular, the path 610 may generally correspond to the movement of an endoluminal device during an endoluminal procedure. However, the path 610 may not be visible in the as-acquired image 600 because it is a calculated line superimposed on the extraluminal image. In some embodiments, the system automatically distinguishes between angiograms with contrast (standard angiograms) and angiograms without contrast (zero-contrast angiograms).

[0066]

[0082] In some embodiments, image 600 may instead be a low contrast image or an ultra-low contrast image. An ultra-low contrast image 600 may be an x-ray image acquired with less than 20 cc of contrast agent introduced into the vasculature. A low contrast image may be an image acquired using a larger amount of contrast agent.

[0067]

[0083] In some embodiments, the processor circuit 510 can receive and store in a memory in communication with the circuit 510 the angle 690 and zoom setting of the extraluminal imaging device. The angle 690 can correspond to the C-arm angle relative to the patient's anatomy when the image 600 was acquired. The zoom setting can correspond to the amount of zoom (if any) of the extraluminal imaging system being used while acquiring the image 600. This information can be provided to the user or used by the processor circuit 510 in subsequent procedures. Once a zero contrast angiogram is identified, the position synchronization workflow, user display, and calculations are optimized for this scenario in accordance with the inventive elements described herein. For example, the processor circuit (e.g., the processor circuit 510 of FIG. 5) can be configured to guide the user to acquire the necessary data and perform the necessary procedures to perform the zero contrast position synchronization by displaying a prompt or label for the user on the display (e.g., the display 132).

[0068]

[0084] The extraluminal image 600 may be any suitable type of extraluminal image. For example, the image 600 may be a cine image acquired without contrast, or a fluoroscopic image acquired without contrast. In some embodiments, a cine image may correspond to an x-ray image acquired at a relatively high radiation dose or a relatively high frame rate, and thus may be a relatively high resolution image. In some embodiments, a fluoroscopic image may be an x-ray image acquired at a relatively low radiation dose or a relatively low frame rate, and thus may be a relatively low resolution image.

[0069]

[0085] It should be noted that the path 610 shown in FIG. 6 may be a motion-compensated path. Various techniques can be used to account for the motion of the patient's anatomy during imaging, as described in more detail below with reference to FIGS. 7-11. For example, in an example where the coronary arteries are imaged by an IVUS imaging device, the patient's anatomy being imaged as shown in image 600 may be constantly moving with the beating of the heart. As a result, the radiopaque portion of the IVUS device may be constantly moving in a cyclical pattern with the beating of the heart. As a result, the observed motion of the IVUS device may not initially appear as the path 610 shown in FIG. 6, but may be a series of positions that indicate motion in one or more directions.

[0070]

[0086] FIG. 7 illustrates a relationship between multiple extraluminal images 710 and a set of locations 740 according to an embodiment of the disclosure. During one step of the disclosure, such as an endoluminal pullback procedure, the processor circuit 510 may be configured to receive multiple extraluminal images 710. The multiple extraluminal images 710 may be acquired by the extraluminal imaging system 151. The extraluminal images 710 may display one or more radiopaque portions of an endoluminal sensing device 720 (e.g., an endovascular imaging catheter, an endovascular pressure sensing guidewire, etc.). As the device moves through the patient's vasculature, each successive extraluminal image 710 may display the radiopaque portion of the endoluminal device 720 at a different location within the image. These locations of the radiopaque portions of the endoluminal imaging device 720 may be stored in a memory in communication with the processor circuit 510. These locations may be stored as pixel coordinates within the image. For example, as shown in image 710 of FIG. 7, the device 720 may be observed at location 730 within the image 710. Coordinates corresponding to location 730 may be stored in memory in association with image 710. In some embodiments, all images 710 may be acquired using extraluminal imaging system 151 at the same angle 690 and zoom setting used to acquire image 600 of FIG. 6. In some embodiments, image 600 may be selected as one of images 710.

[0071]

[0087] A set of locations 740 may be created from all coordinates of the device 720's locations in all received images 710. Image 700 shown in FIG. 7 may represent the set of locations 740. The set of locations 740 may identify multiple (e.g., some, all, or substantially all) locations of one or more radiopaque portions of device 720 while device 720 is passing through a vessel of the patient's anatomy. As shown in FIG. 7, the set of locations 740 may include a direction 741 parallel to path 740 and a direction 742 perpendicular to the direction of path 740. In some embodiments, direction 741 may correspond to a direction of movement of the device within the vessel while collecting intravascular data (e.g., intravascular images, intravascular pressure), such as during a pullback. As shown in FIG. 7, and specifically image 700, the location of device 720 may include various positions in both parallel direction 741 and perpendicular direction 742. In some embodiments, the vessel being imaged may move with the movement of the patient's anatomy during the imaging procedure. For example, when imaging blood vessels within a patient's heart, the heart may continuously pump blood toward the rest of the patient's anatomy throughout the imaging procedure. In this example, as various muscles of the heart move, the various blood vessels of the heart (including the heart vessel in which the intraluminal device 720 is located) move. These muscle movements may cause fluctuations in the position of the intraluminal device 720 in either the perpendicular direction 742 or the parallel direction 741.

[0072]

[0088] As indicated by arrow 762, a location observed in image 710 may be identified or associated with a set of locations 740 in image 700. In some embodiments, image 700 is a composite image showing the locations of radiopaque portions from multiple (e.g., some, all, or substantially all) images 710. In this manner, data (e.g., IVUS images or physiological data) collected by device 720 at various locations of device 720 may be associated with a corresponding location in set of locations 740. As an example, location 730 shown in image 710 may also be identified in image 700. Aspects of determining and displaying the path traveled by a device within a blood vessel are described in U.S. Application Serial No. 15 / 630,482, filed June 22, 2017, entitled "Estimating the endoluminal path of an endoluminal device along a Lumen," which is incorporated herein by reference in its entirety.

[0073]

[0089] FIG. 8 is a schematic diagram of a shape 840 based on the set of locations 740 according to an aspect of the disclosure. In some embodiments, the shape 840 is formed to include only the set of locations 740. In some embodiments, the shape 840 may be an open shape. The shape 840 may be displayed within the image 800. This may be performed by any suitable image processing technique. For example, the processor circuit 510 may identify a region of the image 700 that corresponds to the set of locations 740. For example, the processor circuit 510 may be configured to identify an outer edge of all pixel coordinates that define the set of locations 740. The outer edge may define the shape 840. The processor circuit 510 may use any suitable image processing technique. For example, the system 100 may use image processing techniques such as edge detection, image editing or restoration, linear filtering or other filtering methods, image padding, or other suitable image processing techniques. For example, the system 100 may use a pixel-by-pixel analysis to identify longitudinally adjacent dark pixels within the image 700. In some embodiments, the system 100 may use deep learning techniques to identify the location of the outer edge of the shape 840.

[0074]

[0090] FIG. 9 is a schematic diagram of footprint lines 940 of a shape 840 calculated based on the motion of an endoluminal device, according to an aspect of the disclosure. FIG. 9 includes an image 800 having a shape 840 and an identified calculated footprint line 940. The calculated footprint line 940 may be referred to as a calculated footprint line, a corrected footprint line, a path, a corrected path, a centerline, a corrected centerline, a motion corrected path, a motion corrected footprint line, a motion corrected centerline, or other terminology. In some embodiments, the processor circuit 510 may identify various directions associated with the shape 840. For example, a direction 941 may correspond to a parallel direction of the shape 840 along the length of the shape 840. And, a direction 942 may correspond to a perpendicular direction of the shape 840.

[0075]

[0091] In some embodiments, the processor circuit 510 may be configured to calculate the width of the shape 840 at every position of the shape 840. For example, the processor circuit may start at a distal position 950 of the shape 840 and determine the width in the vertical direction 942 at each position along the shape 840 to a proximal position 960. A calculated footprint line 940 may then be calculated based on these width measurements along the length of the shape 840. For example, the processor circuit may determine the width at each position along the shape 840 and place the calculated footprint line 940 at a distance of half this width from either perimeter of the shape 840. This calculated footprint line 940 may represent the path traversed by the intravascular device in the motion-corrected vessel. In this regard, the calculated footprint line 940 may indicate the movement of the intravascular device through the patient's anatomy if the patient's anatomy was stationary during the imaging procedure. Because the intravascular device is present in the vessel while moving through the vessel, the calculated footprint line 940 may also be an indication of the shape and location of the vessel being imaged. Thus, the shape and location of the imaged vessel can be calculated without the use of contrast in the x-ray frame. For non-contrast angiograms, the algorithms of the present disclosure can map the estimated lumen path (e.g., the calculated footprint line 940) to the contour of the unimaged vessel. This may require the calculated footprint line to match the invisible centerline of the vessel imaged by the IVUS device. As a result, mapping the calculated footprint line to the vessel centerline may introduce inaccuracies that are corrected according to the principles of the present disclosure described herein.

[0076]

[0092] FIG. 10 illustrates the relationship between IVUS data 1030, extraluminal image 710, and calculated footprint line 940. As described with reference to FIG. 7, the set of positions 740 illustrated in FIG. 7 corresponds to the position of an intravascular imaging device 720 moving within a vessel during an imaging procedure. The calculated footprint line 940 is a simplified illustration of the set of motion-corrected positions 740. Each position of the device 720 in the image 710 corresponds to a position in both the set of positions 740 and the calculated footprint line 940. In this regard, a position 730 in the set of positions 740 described with reference to FIG. 7 may correspond to a similar position 1030 along the calculated footprint line 940. This relationship is illustrated by arrow 1062. Similarly, each position of the device 720 in the image 710 may be associated with one of multiple IVUS images 1030. In some embodiments, the data associated with the position of the device 720 in the image 710 may be other intraluminal data. For example, as discussed above, the endoluminal data 1030 may include IVUS images as shown in FIG. 10, physiological data such as pressure or flow data, or other suitable endoluminal data. As indicated by arrow 1061, each endoluminal data 1030, such as the IVUS image 1030 shown in FIG. 10, may be associated with at least one location in at least one extraluminal image 710. Based on the relationship between the image 710 and the calculated footprint line 940, as indicated by arrow 1062 in FIG. 10, the endoluminal data 1030 associated with the location of the device 720 may likewise be associated with a location along the calculated footprint line 940. For example, the first IVUS image 1030 shown in FIG. 10 may be associated with a location 730 in the first X-ray image 710, as indicated by arrow 1061. The same first IVUS image 1030 shown in FIG. 10 may also be associated with a location 1030 of the calculated footprint line 940, as indicated by arrow 1063. Similar relationships may exist for all IVUS images 1030 or other endoluminal data, all extraluminal images 710, and all positions along the calculated footprint line 940.

[0077]

[0093] FIG. 11 illustrates the relationship between the calculated footprint line 940 and position-synchronized endoluminal data, with a calculated centerline 1140 overlaid on an extraluminal image 1100, according to an embodiment of the present disclosure.

[0078]

[0094] In some embodiments, the calculated footprint line 940 may be defined by multiple pixel coordinates in the image 800. For example, the image 800 may include or be composed of multiple pixels. As an example of these pixels, the image 800 may be divided into multiple boxes 801. Each box 801 may correspond to a pixel of the image. As shown in FIG. 11, the number of boxes 801 representing pixels of the image 800 may be any suitable number. The arrangement and number of boxes 801 shown in the image 800 of FIG. 11 are for illustrative and teaching purposes only. For example, the image 800 may include more or fewer pixels than the pixels shown in the boxes 801 shown in FIG. 11.

[0079]

[0095] In some embodiments, the processor circuit 510 may be configured to receive an additional extraluminal image 1100. The extraluminal image 1100 may be any suitable extraluminal image. For example, the extraluminal image 1100 may be an X-ray image. In one example, the extraluminal image 1100 may be an X-ray image acquired without contrast, such as a fluoroscopic image or a cine image. In some embodiments, the X-ray image 1100 may have the same size as the image 800. For example, the image 1100 may include the same number of pixels as the pixels of the image 800, in the same arrangement and at the same resolution. Furthermore, the angle and zoom of the extraluminal imaging system used to acquire the image 1100 may match the angle and zoom used to acquire the image 710. This same angle may be indicated by the angle 690 displayed next to the image 1100. In some embodiments, the image 800 including the calculated footprint line 940, like the image 1100, may correspond to the same angle 690 and zoom setting as the image 710 used to derive it. As a result, there may be a one-to-one correspondence between pixel 801 in image 800 and pixel 1101 in image 1100. In this regard, a location in the patient's anatomy represented by a single pixel 801 in image 800 may also be represented by the corresponding pixel 1101 in image 1100.

[0080]

[0096] As an example of a correspondence between pixel 801 of image 800 and pixel 1101 of image 1100, a location 1030 is shown in each image 800 and 1100. This location 1030 may be a location along the path 940 in image 800, and may be a location along the calculated centerline 1140 in image 1100. In image 800, this location 1030 corresponds to pixel 801. (a) or pixel 801 (a) The same location 1030 corresponds to pixel 1101 (a) or pixel 1101 (a)The relationship between image 800 and calculated footprint line 940, and between image 1100 and calculated centerline 1140, may be represented by arrows 1060 shown in FIG.

[0081]

[0097] FIG. 12 is a schematic diagram of a graphical user interface 1200 according to an aspect of the present disclosure. In some embodiments, the graphical user interface 1200 may be displayed to a user of the system after the steps described in FIGS. 7-11 have been completed. For example, the system may track an endoluminal device in multiple fluoroscopic images to create a path (e.g., path 740 in FIG. 7). The system may then convert path 740 into a calculated footprint line 940, as described with reference to FIGS. 8 and 9. The system may then display the calculated footprint line 940 overlaid on an additional extraluminal image acquired at the same angle and zoom as the extraluminal image acquired during the pullback procedure, as described with reference to FIG. 11.

[0082]

[0098] The extraluminal image 1210 may be an additional extraluminal image similar to the image 1100 described with reference to FIG. 11. As shown in FIG. 12, the image 1210 may include a depiction of a calculated footprint line 1240 superimposed on the image 1210. The calculated footprint line 1240 may be generated by the processor circuit 510 according to the method described with reference to FIGS. 7-11. After the calculated footprint line 1240 is superimposed and displayed on the image 1210, the system 100 may prompt the user to edit the calculated footprint line 1240 to align the calculated footprint line with a user-defined vascular centerline (as described in more detail below with reference to FIG. 13, etc.) or to confirm the path 1240. In this regard, the calculated footprint line 1240 may serve as a roadmap for the final position synchronization calculation.

[0083]

[0099] As shown in FIG. 12, the processor circuitry may be configured to provide a button 1280 or other input element that a user can use to provide a user input indicating that the calculated footprint line 1240 is aligned with the centerline of the vessel. Thus, after an IVUS or physiologic pullback and once an angiogram is acquired (either before or after the pullback), the system automatically switches the user display to a "semi-automatic" mode, allowing the user to edit the generated calculated footprint line to create a roadmap for position-synchronized calculation and display. Aspects of reviewing, editing, or estimating the calculated footprint line may include functions or features described in EP Patent No. 3474750B1, filed June 22, 2016, "Estimating the Endoluminal Path of an Endoluminal Device Along a Lumen," which is incorporated herein by reference in its entirety.

[0084]

[0100] According to some aspects of the present disclosure, a user of the system may verify the shape of the calculated footprint line 1240 based on multiple references. For example, a user of the system may compare to a contrast-filled angiogram of the same patient anatomy to verify that the calculated footprint line 1240 accurately resembles the predicted shape of the vessel. For example, in some embodiments, contrast may have been introduced into the patient's vasculature during a previous procedure. For example, contrast may be introduced into the patient's vasculature in combination with an initial guidewire, such as a Workhorse guidewire, or with the placement of a guidewire of an IVUS imaging device or other intraluminal device. In some embodiments, the contrast introduced may be at a low or very low dose. In some embodiments, a low or very low dose may correspond to a 5 mL or 5 cc volume of contrast of any of the above materials. In some embodiments, an extraluminal image acquired by the extraluminal imaging device 151 while contrast is present in the patient's vasculature may be stored by the processor circuit 510 in a memory in communication with the processor circuit 510. 12, the processor circuit 510 may be further configured to retrieve and display this extraluminal image with contrast (e.g., an angiogram, such as a selected frame from a series of cine frames, with or without contrast) and simultaneously display this image to the user along with the image 1210 and the calculated footprint line 1240. The user of the system 100 may then compare the shape and position of the calculated footprint line 1240 with an angiogram from a previous procedure stored in memory to verify that the calculated footprint line 1240 matches the vascular centerline of the target vessel in the angiogram.

[0085]

[0101] In another embodiment, a user of the system 100 can verify the shape of the calculated footprint line 1240 by comparing it to the observed path of the intraluminal device during the intraluminal procedure used for position synchronization described with reference to FIG. 7. For example, as shown in FIG. 7, the user can verify that the calculated footprint line 1240 resembles the path observed by the user during this step. In some embodiments, the processor circuit 510 can retrieve any or all of the images 710 (FIG. 7) and display them to the user in the graphical user interface 1200 for comparison. In one example, the processor circuit 510 can be configured to display the images 710 in rapid chronological order in succession and replay the device movement within the images 710. The user can verify that the shape and position of the calculated footprint line 1240 are accurate based on the comparison of the shape and position of the calculated footprint line 1240 to the movement of the intraluminal device within the images 710.

[0086]

[0102] In another embodiment, a user of the system 100 may verify the shape and location of the calculated footprint line 1240 by referencing anatomical landmarks or other landmarks in previously viewed images 1210. For example, the user may observe anatomical landmarks, such as various bone structures, abnormalities in bone structures or other patient anatomy, or other anatomical landmarks, during an initial imaging phase (e.g., the intraluminal imaging phase described with reference to FIG. 7). In some embodiments, the landmarks may include man-made structures, such as stents, other therapeutic devices, clips, or other structures. In some embodiments, a user of the system may identify any of these structures during the initial imaging procedure and in the images 1210 and determine the accuracy of the shape and location of the calculated footprint line 1240 based on the location of the calculated footprint line 1240 relative to these landmarks. In some embodiments, the processor circuitry may be configured to receive user input during the initial imaging phase of landmarks in the images 710. The locations of these images may be stored in a memory in communication with the processor circuitry 510 and displayed at the same locations in the images 1210 based on the stored pixel coordinates. This can help the user compare and verify the calculated footprint lines 1240. In some embodiments, the processor circuitry 510 may be configured to automatically identify various landmarks and display them to the user in either the image 710 and / or the image 1210.

[0087]

[0103] In some embodiments, a user of the system 100 can verify the shape and location of the calculated footprint line 1240 by comparing the calculated footprint line 1240 to a non-contrast extraluminal image of the patient's anatomy acquired while the multiple guidewires are positioned within one or more blood vessels of the patient. In this regard, the radiopaque portions of the multiple guidewires highlight the contours of the blood vessels. In some embodiments, this image of the patient's anatomy acquired using the multiple guidewires within the anatomy may be acquired during the same imaging procedure as the procedure acquiring the multiple IVUS images and / or extraluminal images described herein. In some embodiments, the image may have been acquired during a previous procedure and may be retrieved from memory.

[0088]

[0104] In some embodiments, the processor circuitry 510 may be configured to display various prompts to the user. For example, the prompt 1290 may instruct the user to confirm the shape and position of the calculated footprint line 1240, for example, by selecting the button 1280. The prompt 1290 may also inform the user that the user can edit the calculated footprint line 1240 by clicking on the calculated footprint line 1240 in the image 1210, as described in more detail with reference to FIG. 13. In some embodiments, the prompt 1220, or a symbol or image 1220, may quickly inform the user that the user can adjust the position or shape of the calculated footprint line 1240.

[0089]

[0105] An indicator 1230 may be provided on the screen display 1200 to indicate to the user that the x-ray image was acquired without contrast, and thus the user is viewing a zero contrast roadmap. The position synchronization results screen (e.g., interface 1200, or other interfaces depicted in the figures below) is labeled with zero contrast, as shown by indicator 1230. The labeling of zero contrast on the display 1200, and the associated workflow, is clearly understandable to any observer.

[0090]

[0106] According to another aspect of the present disclosure, the calculated footprint line 1240 initially displayed to the user may be different from the calculated footprint line involving contrast-based angiograms and may be closer to the intended roadmap, and therefore may require less editing by the user, since the algorithm for calculating and displaying the calculated footprint line does not require obtaining or identifying blood vessels filled with contrast agent, as described, for example, in EP 3 474 750, incorporated by reference above.

[0091]

[0107] 13 is a schematic diagram of a graphical user interface 1300 according to an aspect of the disclosure. In some embodiments, the graphical user interface 1300 may be displayed to a user after the user selects an input to edit a path, such as the calculated footprint line 1240 of FIG.

[0092]

[0108] In the example shown in Figure 13, an extraluminal image 1310 is provided. Image 1310 may be similar to image 1210 described with reference to Figure 12 and / or image 1100 described with reference to Figure 11. In some embodiments, image 1310 may be an extraluminal image (e.g., an x-ray image) acquired without introducing contrast into the patient's vasculature.

[0093]

[0109] As shown in FIG. 13, the image 1310 may include a depiction of a calculated footprint line 1340. The calculated footprint line 1340 may be similar to the calculated footprint line 1240 described above. In the example shown in FIG. 13, a user may edit the shape and location of the calculated footprint line 1340 to match the known shape and location of the imaged vessel. For example, the user may determine the desired or correct shape based on a previously acquired angiogram image (e.g., an x-ray image acquired with contrast agent introduced into the vasculature), a view of the movement of the endoluminal device during a previous endoluminal procedure, nearby anatomical or artificial landmarks, or other references. As shown in FIG. 13, the calculated footprint line 1340 may pass through a section 1352 of the image. A user of the system may know that based on any of the above references, the calculated footprint line 1340 should actually match the shape shown in region 1354 of the image. Note that pathways may be displayed in region 1354, e.g., pathways identified as blood vessels containing contrast, but this is displayed for instructional purposes only. In most implementations where contrast is not present, the desired or corrected location of any region of the calculated footprint line 1340 may not be displayed to the user. However, the user may know the corrected location based on the above references.

[0094]

[0110] As shown in the graphical user interface 1300, the processor circuitry 510 may be configured to provide various user-selectable tools within the display for editing the shape and / or position of the calculated footprint line 1340. For example, as shown in FIG. 13, an indicator 1302 may indicate an area of ​​the calculated footprint line 1340 that the user has modified. The indicator 1302 may or may not be displayed. In some embodiments, after the user selects an input of the processor circuitry 510 to enter the path shape editing mode, the user may select any location along the calculated footprint line 1340. In some embodiments, the user touches a location on the calculated footprint line 1340 and drags it (e.g., on a touch screen display, using a mouse, etc.) to a new location that represents the correct shape of the calculated footprint line 1340. As an example, the user may select a location within the area 1352 and move it to a location within the area 1354 that represents the correct shape of the calculated footprint line 1340. In response to user input, the processor circuitry 510 may be configured to modify the shape and / or position of the calculated footprint line 1340 such that the calculated footprint line 1340 passes through the region 1354.

[0095]

[0111] In some embodiments, this modification of the shape and position of the calculated footprint line 1340 may include an interpolation between anchors (e.g., anchor 1304 and / or other anchors along the calculated footprint line 1340) that define the calculated footprint line 1340. In some embodiments, the interpolation may include a local interpolation. The anchor 1304 may or may not be displayed to the user. For example, only anchor points or regions of the calculated footprint line 1340 that are close to the moved anchor 1304 may be adjusted, while regions of the calculated footprint line 1340 that are far from the anchor 1304 may remain unchanged. In some embodiments, the indicator 1302 may define a proximity region around the anchor 1304. Sections of the path 1304 within the region defined by the indicator 1302 may be modified, while sections outside the anchor 1302 may remain unchanged. In some embodiments, a user of the system 100 may adjust various settings or aspects of the interpolation algorithm, such as, for example, the size and shape of the indicator 1302.

[0096]

[0112] Some embodiments for modifying the shape and position of the calculated footprint line 1340 may include features similar to those described in U.S. Provisional Application No. 63 / 187,964, filed May 13, 2021 (International Publication No. WO2022 / 238276), “PATHWAY MODIFICATION FOR COREGISTRATION OF EXTRALUMINAL IMAGE AND INTRALUMINAL DATA,” which is incorporated by reference in its entirety herein.

[0097]

[0113] In some embodiments, after the calculated footprint line 1340 has been modified to the user's satisfaction, the processor circuit 510 receives an input indicating that the path has been confirmed and the system may exit the path modification mode.

[0098]

[0114] Figure 14 is a schematic diagram of a graphical user interface 1400. The graphical user interface 1400 may be displayed to a user after a path (e.g., the calculated footprint line 1340 of Figure 13, the calculated footprint line 1240 of Figure 12, and / or the centerline 1140 of Figure 11) has been confirmed and / or modified.

[0099]

[0115] After a route, such as any of the routes described above, has been confirmed and / or modified by a user, the processor circuitry 510 may be configured to positionally synchronize any endoluminal data to the route. For example, as described with reference to Figures 7 and 10, endoluminal data, such as IVUS imaging data and / or physiological data, may be associated with positions along the confirmed route. When the route is overlaid on an extraluminal image, the endoluminal data may be displayed to correspond to positions in the extraluminal image, which positions indicate the positions along the vessels indicated by the route at which the endoluminal data was acquired.

[0100]

[0116] As an example, the graphical user interface 1400 provides an x-ray image 1410, an IVUS image 1430, physiological data 1490, and a longitudinal section 1450 of the vessel being imaged. The x-ray image 1410 may include a depiction of a calculated footprint line 1440. The calculated footprint line 1440 may be similar to the center line 1140 of FIG. 11, the path 1240 of FIG. 12, and / or the calculated footprint line 1340 of FIG. 13. In some embodiments, the calculated footprint line 1440 may be a path corresponding to the movement of the intravascular imaging catheter as modified and / or confirmed by the user. The calculated footprint line 1440 may be overlaid on the image 1410 and may identify the location of the vessel being imaged. Various indicators related to the position-synchronized endoluminal data may be displayed along or next to this calculated footprint line 1440.

[0101]

[0117] As an example, the iFR data 1490 may be positionally synchronized to the calculated footprint line 1440. For example, the iFR data may be received by the processor circuit 510 during an iFR pullback, and an extraluminal image (e.g., image 710 of FIG. 7) may be received at the same time. Once the iFR data is acquired and associated with a location in the extraluminal image, the iFR data may be identified at a location along the calculated footprint line 1440. As an example, an indicator 1422 may be provided along the calculated footprint line 1440. The indicator 1422 may correspond to a location along the calculated footprint line 1440 where the iFR data 1490 was acquired, such as an iFR estimated metric. Similarly, an indicator 1494 may be provided in the image 1410 along the calculated footprint line 1440. The indicator 1494 may identify a distal location where the iFR data 1490 was acquired, such as an iFR distal value displayed as part of the data 1490.

[0102]

[0118] Also displayed within the graphical user interface 1400 is an IVUS image 1430. In this regard, multiple IVUS images (including image 1430) may be positionally synchronized to the calculated footprint line 1440. The IVUS image 1430 may be an IVUS image acquired at a location identified by an indicator 1422. In some aspects, the indicator 1422 may also be referred to as a marking. The IVUS image 1430 may alternatively be an IVUS image acquired at a location identified by an indicator 1494. In some embodiments, the IVUS image 1430 may include a boundary 1432. The boundary may be automatically identified by the processor circuit 510 or by a user of the system. In some embodiments, the boundary 1432 may be a lumen boundary, a vessel boundary, a stent boundary, or other boundary within the image.

[0103]

[0119] Examples of boundary detection, image processing, image analysis, and / or pattern recognition include U.S. Patent No. 6,200,268, “VASCULAR PLAQUE CHARACTERIZATION”, issued on March 13, 2001 to D. Geoffrey Vince, Barry D. Kuban, and Anuja Nair as inventors; U.S. Patent No. 6,381,350, “INTRAVASCULAR ULTRASONIC ANALYSIS USING ACTIVE CONTOUR METHOD AND SYSTEM”, issued on April 30, 2002 to Jon D. Klingensmith, D. Geoffrey Vince, and Raj Shekhar as inventors; and U.S. Patent No. 7,074,188, “SYSTEM AND METHOD OF CHARACTERIZING VASCULAR TISSUE”, issued on July 11, 2006 to Anuja Nair, D. Geoffrey Vince, Jon D. Klingensmith, and Barry D. Kuban as inventors. No. 7,175,597, “NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD,” issued on February 13, 2007 to Geoffrey Vince, Anuja Nair, and Jon D. Klingensmith as inventors; U.S. Patent No. 7,215,802, “SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION,” issued on May 8, 2007 to Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince as inventors; U.S. Patent No. 7,359,554, “SYSTEM AND METHOD FOR IDENTIFYING A VASCULAR BORDER,” issued on April 15, 2008 to Jon D. Klingensmith, D. Geoffrey Vince, Anuja Nair, and Barry D. Kuban as inventors; Nair, Barry D. Kuban, and D.No. 7,463,759, entitled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," issued on December 9, 2008 to Geoffrey Vince as an inventor, the teachings of which are incorporated herein by reference in their entireties.

[0104]

[0120] Additionally, metrics 1434 are displayed on the interface 1400. The metrics 1434 may be related to the displayed IVUS image 1430, and specifically the boundary 1432. For example, the processor circuit 510 may automatically calculate various metrics 1434 related to the boundary 1432. For example, the processor circuit 510 may determine a cross-sectional area of ​​the boundary 1432. The processor circuit may also identify a minimum diameter of the boundary, a maximum diameter of the boundary, or other measurements or metrics related to the boundary 1432, or other aspects of the image 1430.

[0105]

[0121] In some embodiments, a longitudinal view 140 may also be displayed. The longitudinal view 1450 may also be referred to as an in-line digital (ILD) view or an intravascular longitudinal view (ILD) 1450. An IVUS image acquired during an intravascular ultrasound imaging procedure, such as an IVUS pullback, may be used to create the ILD 1450. In this regard, the IVUS image is a tomographic or radial cross-sectional view of the vessel. The ILD 1450 provides a longitudinal view of the vessel. The ILD 1450 is a stack of IVUS images acquired at various positions along the vessel, such that the longitudinal view of the ILD 1450 is perpendicular to the radial cross-sectional view of the IVUS images. In such an embodiment, the ILD 1450 indicates the length of the vessel, while each individual IVUS image is a single radial cross-sectional image at a given position along the length. In some embodiments, the ILD 1450 may indicate the time the IVUS image was acquired, and the lateral position of the ILD 1450 may correspond to the timestamp of the IVUS image. In another embodiment, the ILD 1450 may be a stack of IVUS images acquired over time during the imaging procedure, and the length of the ILD 1450 may represent the time or duration of the imaging procedure. The ILD 1450 may be generated and displayed in real time or near real time during the pullback procedure. As additional IVUS images are acquired, they may be added to the ILD 1450. For example, at some point during the pullback procedure, the ILD 1450 shown in FIG. 9 may be partially complete. In some embodiments, the processor circuit may generate a longitudinal cross-sectional view of the vessel being imaged based on the received IVUS images. For example, rather than displaying actual vessel image data, the view may be a stylized version of the vessel, e.g., a continuous line may be used to indicate the luminal and vascular boundaries of the vessel. As shown in FIG. 11, the ILD 1450 may represent a stylized ILD showing a luminal boundary 1156 that extends as a continuous line throughout the ILD 1450. The location of the luminal boundary 1156 may be symmetrically arranged around a central axis and arranged according to the luminal diameter calculated within each corresponding IVUS image.

[0106]

[0122] The ILD 1450 may include a depiction of the iFR data 1492, various length measurements 1462, indicators 1452 and 1456 identifying the start and end of the length measurements, and a bookmark identifier 1454. Aspects of providing physiological data (e.g., pressure ratio data such as iFR data 1492) on the ILD 1450 are described in U.S. Provisional Application No. 63 / 288,553, “REGISTRATION OF INTRALUMINAL PHYSIOLOGICAL DATA TO LONGITUDINAL IMAGE OF BODY LUMEN USING EXTRALUMINAL IMAGING DATA,” filed December 11, 2021, which is incorporated by reference herein in its entirety.

[0107]

[0123] In some embodiments, the iFR data 1492 may be the same as the iFR data used for the metrics 1490 above. As shown in the ILD 1450, and because the ILD 1450 is generated based on IVUS data, when two intracavity procedures (e.g., IVUS data and physiologic data) are performed and positionally synchronized to the same path (e.g., path 1440), the same IVUS data and physiologic data may be positionally synchronized to each other, as shown by the iFR data 1492 displayed in position along the ILD 1450.

[0108]

[0124] The length measurements along the ILD 1450 may be generated by a user of the system 100 or may be generated automatically by the processor circuitry 510. For example, a user may select various locations along the ILD 1450 and the processor circuitry may calculate the length measurements that correspond to the selected locations. These various length measurements may be displayed as metrics 1460 near the ILD 1450. In some embodiments, the length measurements may be distinguished from one another by labels, colors, patterns, highlights, or other visual characteristics.

[0109]

[0125] The indicators 1452 and 1456 may be user selected locations along the ILD 1450 or may be automatically selected in some embodiments. As an example, the indicators 1452 and 1456 may identify the start and end locations of a length measurement. In some embodiments, the indicators 1452 and 1456 correspond to the distal and proximal landing zones of a stent under consideration by a physician. The iFR estimate included in the physiological data 1490 may be a predicted iFR value with a proposed stent placed in the vessel based on the indicators 1452 and 1456. In some embodiments, a corresponding indicator may be displayed at a corresponding location along the calculated footprint line 1440 of the image 1410.

[0110]

[0126] In some embodiments, one or more bookmarks 1454 may be included along the ILD 1450. These bookmarks 1454 may correspond to similar bookmarks at corresponding locations along the calculated footprint line 1440 of the image 1410.

[0111]

[0127] Screen display 1400 displays indicator 1470 superimposed on x-ray image 1410. Indicator 1470 indicates to the user that the x-ray image is a zero contrast image frame.

[0112]

[0128] 15 is a schematic diagram of a graphical user interface 1500 according to an embodiment of the present disclosure. As shown in FIG. 15, the graphical user interface may include an extraluminal image 1510, an image 1512, and a prompt 1530.

[0113]

[0129] In some embodiments, the processor circuit 510 may initiate the step of positionally synchronizing the endoluminal data to the non-contrast extraluminal image as described above in response to a user input selecting a non-contrast extraluminal image or by automatically detecting the non-contrast extraluminal image. For example, as shown in FIG. 15, the processor circuit may display to the user a number of selectable options 1512 corresponding to angiographic images (e.g., x-ray images acquired with contrast) and fluoroscopic images (e.g., x-ray images acquired without contrast). In some embodiments, the selectable options 1512 may correspond to images. In some embodiments, the images 1512 may be examples of angiographic images acquired with contrast and fluoroscopic or cine images acquired without contrast, respectively. In some embodiments, these images may correspond to or be images of a particular patient's anatomy acquired during an imaging or therapeutic procedure. If the user selects an image corresponding to a non-contrast image, the steps described in this disclosure may be initiated by the processor circuit. If the user selects an image corresponding to an image with contrast, the processor circuit 510 may initiate a step of positionally synchronizing the endoluminal data to the contrast-filled angiogram.

[0114]

[0130] In embodiments in which the processor circuit 510 automatically determines whether a contrast-filled angiogram, a contrast-free fluoroscopic image, or a cine image is presented, the processor circuit 510 may receive the extraluminal image from an extraluminal imaging system during the procedure or from a memory in communication with the processor circuit 510. In such embodiments, the processor circuit 510 may use any suitable image processing and / or machine learning techniques, including those enumerated in this disclosure, to determine whether the received image is an angiogram or a contrast-free image. If an angiogram is received, the steps of positional synchronization to the angiogram may be initiated. If a contrast-free extraluminal image is received, the steps described herein may be initiated.

[0115]

[0131] In some embodiments, the processor circuitry 510 may be configured to display a prompt, such as prompt 1530, to guide the user through this stage of the procedure. For example, the processor circuitry 510 may display prompt 1530 to guide the user to select an existing angiogram, fluoro, or cine image and / or to acquire additional images according to prompt 1530.

[0116]

[0132] FIG. 16 is a flow diagram of a method for positionally synchronizing endoluminal data to non-contrast X-ray image frames, according to an embodiment of the present disclosure. Method 1600 may represent automated vessel segmentation to detect segments of interest using positional synchronization of invasive physiology and X-ray images. As illustrated, method 1600 includes multiple enumerated steps, but embodiments of method 1600 may include additional steps before, after, or between the enumerated steps. In some embodiments, one or more of the enumerated steps may be omitted, performed in a different order, or performed simultaneously. The steps of method 1600 may be performed by any suitable component in system 100, and not all steps need to be performed by the same component. In some embodiments, one or more steps of method 1600 may be performed by or under the direction of a processor circuit of diagnostic system 100, including, for example, processor 560 (FIG. 5) or any other component.

[0117]

[0133] In step 1605, the method 1600 includes receiving a first plurality of extraluminal images acquired by an extraluminal imaging device. The extraluminal imaging device may be a device of the extraluminal imaging system 151 shown and described with reference to FIG. 1. In some aspects, the extraluminal images of the first plurality of extraluminal images may be cine images. Acquiring the extraluminal images using a high radiation dose results in higher quality images. In some aspects, the first plurality of extraluminal images may be angiography frames. The first plurality of extraluminal images may be acquired with or without contrast.

[0118]

[0134] In step 1610, the method 1600 includes receiving a second plurality of extraluminal images acquired by an extraluminal imaging device while an intraluminal catheter or guidewire is moving within the patient's body cavity. In some aspects, the intraluminal catheter may be an intraluminal device 102 as shown and described with reference to FIG. 1. In some aspects, the second plurality of extraluminal images may be fluoroscopic image frames. In some aspects, the second plurality of extraluminal images may be extraluminal images acquired with less radiation exposure than the first plurality of extraluminal images. The second plurality of extraluminal images may depict a radiopaque portion of the intraluminal device moving within the patient's body cavity. In a procedure imaging the heart, or other constantly and / or periodically moving organs or structures, the position of the radiopaque portion of the intraluminal device may be affected by its motion. This motion may exhibit periodic or sinusoidal behavior. As a result, the path of the intraluminal device in the second plurality of extraluminal images may not coincide with the centerline of the lumen imaged in the static image. In this regard, the second plurality of extraluminal images are acquired during a plurality of anatomical cycles such that the intraluminal catheter or guidewire undergoes cyclical motion during its passage through the body lumen. This motion may include side-to-side motion, lateral, perpendicular, parallel, or longitudinal motion relative to the motion of the intraluminal device. The second plurality of extraluminal images may be acquired during the same procedure as the first plurality of extraluminal images or during a different procedure.

[0119]

[0135] In step 1615, the method 1600 includes receiving endoluminal data points acquired by the endoluminal catheter or guidewire during movement. The endoluminal data points may be of any appropriate type, including IVUS data, OCT data, intravascular pressure data, intravascular flow data, or any other data. Additionally, the endoluminal data points are acquired simultaneously with the second plurality of extraluminal images.

[0120]

[0136] In step 1620, the method 1600 includes determining a curve representing at least one of the shape or location of the body cavity based on the second plurality of extraluminal images. In some aspects, the curve may be referred to as a footprint line (FPL) and may be an approximation of the path of the endoluminal device through the body cavity in the absence of motion of the patient's anatomy. This calculated footprint line may be a rough / smooth representation of the body cavity, or a representation of the average location of the body cavity. This may be based, for example, on analysis of the pullback images (e.g., the second plurality of extraluminal images) and detection of the endoluminal device (e.g., the opaque tip of the guidewire (GW) or a radiopaque marker such as the guide catheter (GC)). In this regard, the calculated FPL is a rough / smoothed representation of the vessel, or the average location of the vessel (subject to periodic motion as described above). The curve may also be referred to as a line, curve, path, centerline, roadmap, or other terms.

[0121]

[0137] In step 1625, the method 1600 includes determining whether the first plurality of extraluminal images were acquired with contrast. In some aspects, the processor circuit of the system 100 may analyze one or more of the first plurality of extraluminal images to determine whether the images were acquired with contrast. For example, a machine learning algorithm, such as a neural network or other deep learning network, may be implemented to automatically identify whether the extraluminal images were acquired with contrast. As shown in FIG. 16, if the processor circuit determines that the first plurality of extraluminal images were acquired with contrast, the processor circuit may perform steps 1630-1640, described below. If the processor circuit determines that the first plurality of extraluminal images were acquired without contrast, the processor circuit may perform steps 1645-1670, described after the description of steps 1630-1640.

[0122]

[0138] In step 1630, the method 1600 includes identifying an extraluminal image of the first plurality of extraluminal images based on the curve. The extraluminal image may be selected automatically. For example, the processor circuit may extract a centerline of the imaged body cavity and compare it to the curve. In some aspects, the processor circuit may compare multiple locations of the curve to corresponding locations of the centerline identified in each extraluminal image of the first plurality of extraluminal images. For example, for an extraluminal image, a proximal location of the centerline may be compared to a proximal location of the curve. This comparison may result in a distance between the two locations, for example, in pixels or other units. This comparison may be performed for each point along the centerline and the corresponding curve (e.g., the centerline and the curve may be compared at regular distance intervals or the centerline and the curve may be divided into an equal number of sections and a comparison may be performed for each section). After the position comparison is performed and multiple distance values ​​are obtained, these values ​​may be averaged, summed, or otherwise combined to determine an overall comparison value for the analyzed extraluminal image. In this regard, the processor circuitry may select the extraluminal image having an ideal comparison value (e.g., lowest, closest to a reference value, highest, etc.) that indicates that the shape of the body cavity in that extraluminal image is closest to the curve generated in step 1620.

[0123]

[0139] In some embodiments, after the processor circuit selects an extraluminal image of the first plurality of extraluminal images, the user can verify that the selected extraluminal image ideally matches the curve. The user can then correct or select a new image. In some embodiments, the user can manually correct the automatically derived centerline results and / or completely redraw a new centerline.

[0124]

[0140] At step 1635, the method 1600 includes positionally synchronizing the endoluminal data points to a centerline of the body cavity in the extraluminal image. Because the endoluminal data points are associated with corresponding positions along the curve (e.g., acquisition positions of the endoluminal data points as viewed in the second plurality of extraluminal images), the curve and corresponding position information of the endoluminal data points may be overlaid on the selected extraluminal image. As a result, the positions at which the endoluminal data points were acquired may be viewed in the extraluminal image.

[0125]

[0141] At step 1640, the method 1600 includes outputting the extraluminal image and the position-synchronized endoluminal data points, which may include any suitable graphical user interface that includes the extraluminal image showing the positions where the endoluminal data points were acquired along with the endoluminal data points.

[0126]

[0142] As described above, if the processor circuit determines in step 1625 that the first plurality of extraluminal images was acquired without contrast, it may instead perform steps 1645-1670. In step 1645, the method 1600 includes identifying an extraluminal image of the first plurality of extraluminal images. The extraluminal image may be selected based on the orientation of the extraluminal imaging device and the patient. For example, the selected extraluminal image should be an image acquired from the same angle and with the same imaging settings as the second plurality of extraluminal images. In some aspects, the extraluminal image selected in step 1645 may instead be one of the second plurality of extraluminal images. Because the first plurality of extraluminal images was acquired without contrast, the body cavity and centerline of the body cavity are not visible in the first extraluminal image. In some aspects, the extraluminal image identified in step 1645 may be an extraluminal image of the second plurality of extraluminal images received in step 1610.

[0127]

[0143] In step 1650, the method 1600 includes overlaying the curve on the selected extraluminal image. In this regard, step 1650 includes setting the lumen centerline as the calculated FPL or curve in the selected non-contrast extraluminal image. In this regard, the processor circuit does not identify the extraluminal image in step 1645 based on the centerline of the lumen, as in step 1630. In some aspects, the processor circuit assigns the curve as the centerline regardless of the actual location and shape of the lumen and the centerline. The processor circuit does this because the curve represents the actual location and shape of the lumen and the centerline with sufficient accuracy.

[0128]

[0144] In step 1655, the method 1600 includes outputting the extraluminal images and the curve superimposed thereon. This may include overlaying the curve (e.g., the calculated FPL) on a selected extraluminal image. A user can then review the curve in the extraluminal image and determine whether the curve accurately represents the expected location of the body cavity based on observing the acquisition of a second plurality of extraluminal images.

[0129]

[0145] In step 1660, method 1600 includes receiving user input to modify or approve the curve. For example, if the user determines that a portion of the curve needs to be modified, the user can use an input device, such as a touch screen, mouse, keyboard, various buttons in a graphical user interface, or other means, to adjust the curve as needed. In some aspects, the curve may not need to be modified; however, the user may provide user input approving that the shape of the curve is correct. In some aspects, the system workflow may force the user to review, correct, and / or completely redraw the entire centerline of the vessel.

[0130]

[0146] At step 1665, the method 1600 includes positionally synchronizing the endoluminal data points to positions within the extraluminal image. For example, the endoluminal data points may be associated with various positions along a curve, as described at step 1640. These endoluminal data points may likewise be associated with corresponding positions within the selected extraluminal image.

[0131]

[0147] At step 1670, method 1600 includes outputting the extraluminal image and the position-synchronized endoluminal data points to a display. Step 1670 may be similar to step 1640 above. For example, the display may provide any suitable graphical user interface including the extraluminal image showing the positions where the endoluminal data points were acquired along with the endoluminal data points.

[0132]

[0148] Those skilled in the art will recognize that the above-mentioned devices, systems, and methods may be modified in various ways. Therefore, those skilled in the art will understand that the embodiments covered by the present disclosure are not limited to the specific embodiment examples above. Although illustrative embodiments have been shown and described, the above disclosure contemplates various modifications, changes, and substitutions. It is understood that such modifications may be made above without departing from the scope of the present disclosure. Therefore, it is appropriate that the appended claims be broadly construed in accordance with the present disclosure.

Claims

1. 1. A system comprising a processor circuit in communication with an extraluminal imaging device and an intraluminal catheter or guidewire, the processor circuit comprising: receiving a first extraluminal image acquired by the extraluminal imaging device; receiving a plurality of second extraluminal images acquired by the extraluminal imaging device during movement of the intraluminal catheter or guidewire within the patient's body cavity, the plurality of second extraluminal images being acquired without contrast agent within the body cavity; receiving a plurality of endoluminal data points acquired by the endoluminal catheter or guidewire during said movement; determining a curve representing at least one of a shape or a position of the body cavity based on the plurality of second extraluminal images; determining whether the first extraluminal image was acquired without the contrast agent present within the body cavity; In response to determining that the first extracavitary image was acquired without the contrast agent in the body cavity, assigning the curve as a centerline of the body cavity in the first extraluminal image; position-synchronizing the plurality of endoluminal data points to positions along the curve; outputting a first screen representation on a display in communication with the processor circuit, the first screen representation comprising: the first extracavitary image; a visual representation of an endoluminal data point of the plurality of endoluminal data points; and markings superimposed on the extraluminal image at locations corresponding to the endoluminal data points. Outputting and To run the system.

2. In response to determining that the first extraluminal image was acquired without the contrast agent in the body cavity, the processor circuit: A second screen display is output to the display, and the second screen display includes: the first extraluminal image, and The system of claim 1 , further comprising the curve superimposed on the first extraluminal image.

3. 3. The system of claim 2, wherein the second screen display includes a plurality of user input options for at least one of accepting the centerline, correcting the centerline, or drawing a new centerline.

4. 4. The system of claim 3, wherein if a user input option to correct the centerline is selected, the processor circuit receives user input to identify a region of the curve and selects a new location in the first extraluminal image that corresponds to the corrected location of the region.

5. The system of claim 3 , wherein the processor circuit performs the position synchronization and outputs the first screen display only after receiving user input via the plurality of user input options.

6. the processor circuit is in communication with a touchscreen display; the processor circuit outputs the first screen representation to the touch screen display; The system of claim 1 , wherein the processor circuit receives user input from the touchscreen display.

7. The system of claim 1 , wherein the extraluminal imaging device comprises an X-ray imaging device.

8. The system of claim 7 , wherein the first extracavitary image is acquired at a first radiation dose and the plurality of second extracavitary images are acquired at a second radiation dose that is less than the first radiation dose.

9. The processor circuitry includes: receiving a plurality of first extracavitary images acquired by the extracavitary imaging device; The system of claim 1 , further comprising: selecting the first extraluminal image from among the plurality of first extraluminal images.

10. 2. The system of claim 1, wherein the processor circuit automatically determines whether the first extraluminal image was acquired without the contrast agent without receiving user input to identify whether the first extraluminal image was acquired without the contrast agent.

11. the plurality of second extraluminal images showing a radiopaque portion of the intraluminal catheter or guidewire; The system of claim 1 , wherein the processor circuit determines the curve based on the radiopaque portions shown in the plurality of second extraluminal images.

12. 12. The system of claim 11, wherein the plurality of second extraluminal images are acquired during a plurality of anatomical cycles such that the intraluminal catheter or guidewire experiences cyclical motion while passing through the body lumen, and wherein the processor circuit performs motion compensation to determine the curve.

13. 13. The system of claim 12, wherein to perform the motion compensation, the processor circuitry further positions the curve along a center of a shape generated by movement of the intraluminal catheter or guidewire within the body cavity while the intraluminal catheter or guidewire is undergoing the cyclic motion.

14. The system of claim 1 , wherein the first extraluminal image is one of the plurality of second extraluminal images.

15. 2. The system of claim 1, wherein the processor circuitry further assigns the curve as a centerline of the body cavity in the first extraluminal image without identifying the body cavity in the first extraluminal image and without identifying the centerline in the first extraluminal image.

16. 1. A system comprising a processor circuit in communication with an extraluminal imaging device and an intraluminal catheter or guidewire, the processor circuit comprising: receiving a first extraluminal image acquired by the extraluminal imaging device, the first extraluminal image being acquired without a contrast agent in the body cavity; receiving a plurality of second extraluminal images acquired by the extraluminal imaging device during movement of the intraluminal catheter or guidewire within the patient's body cavity, the plurality of second extraluminal images being acquired without contrast agent within the body cavity; receiving a plurality of endoluminal data points acquired by the endoluminal catheter or guidewire during said movement; positionally synchronizing the plurality of endoluminal data points to the first extraluminal image based on the plurality of second extraluminal images, wherein the positional synchronizing is performed without using extraluminal images acquired with contrast agent present in the body cavity; outputting a first screen representation on a display in communication with the processor circuit, the first screen representation comprising: the first extracavitary image; a visual representation of an endoluminal data point of the plurality of endoluminal data points; and markings superimposed on the extraluminal image at locations corresponding to the endoluminal data points. Outputting and To run the system.

17. an intravascular imaging catheter; 1. A system comprising a processor circuit in communication with an X-ray imaging device and the intravascular imaging catheter, the processor circuit comprising: receiving a first x-ray image acquired by the x-ray imaging device; receiving a plurality of second X-ray images acquired by the X-ray imaging device during movement of the intravascular imaging catheter within a patient's blood vessel, the plurality of second X-ray images being acquired without contrast agent in the blood vessel; receiving a plurality of intravascular images acquired by the intravascular imaging catheter during the movement; determining a curve representing at least one of a shape or a position of the blood vessel based on the plurality of second X-ray images; determining whether the first x-ray image was acquired without the contrast agent in the blood vessel; In response to determining that the first X-ray image was acquired without the contrast agent in the blood vessel, assigning the curve as the centerline in the first x-ray image without identifying the blood vessel in the first x-ray image and without identifying a centerline of a body cavity in the first x-ray image; positionally synchronizing the plurality of intravascular images with positions along the curve; outputting a first screen representation on a display in communication with the processor circuit, the first screen representation comprising: the first x-ray image; an intravascular image among the plurality of intravascular images; and a marking displayed on the extraluminal image at a corresponding position on the intravascular image; Outputting and To run the system.

Images