Registration of endoluminal physiological data with longitudinal images of body cavities using extraluminal image data

Abstract

The system includes a processor circuit that receives intravascular imaging data from the intravascular imaging catheter, x-ray images from the x-ray imaging device, and intravascular pressure data from the intravascular pressure-sensing guidewire. The processor circuit correlates the intravascular imaging data and the intravascular pressure data with positions along the body lumen indicated in the x-ray images. The processor circuit generates a longitudinal view of the body lumen based on the intravascular imaging data and outputs a screen display including the longitudinal view of the body lumen with a superimposed graphical representation corresponding to the intravascular pressure measurements.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to and the benefit of U.S. Provisional Patent Application No. 63 / 288,553, filed December 11, 2021, and U.S. Provisional Patent Application No. 63 / 292,529, filed December 22, 2021, each of which is incorporated by reference in its entirety into this specification.

[0002]

[0002] The present disclosure relates generally to co-registration of data from different medical diagnostic modalities. In particular, physiological data, intravascular imaging data, and X-ray data are tri-registered, and the physiological data is overlaid on a longitudinal view of the intravascular data. [Background technology]

[0003]

[0003] Physicians use many different medical diagnostic systems and tools to monitor the health of patients and diagnose medical conditions. Different modalities of medical diagnostic systems provide physicians with various images, models, and / or data regarding the patient's internal structures. These modalities include invasive devices and systems, such as intravascular systems, and non-invasive devices and systems, such as X-ray systems and computed tomography (CT) systems. By using multiple diagnostic systems to examine a patient's anatomy, physicians can gain further insight into the patient's condition.

[0004]

[0004] In the field of intravascular imaging and physiological measurements, coregistration of data from invasive devices (e.g., intravascular ultrasound (IVUS) devices or instantaneous fractional flow reserve (iFR) devices) with images collected non-invasively (e.g., via x-ray angiography) is a powerful technique for improving the efficiency and accuracy of vascular catheterization procedures. Coregistration identifies the location of intravascular data measurements along a vessel by mapping the data onto an angiographic image of the vessel. Physicians can then know exactly where within the vessel a measurement was made rather than having to estimate location. Coregistration is particularly useful in the diagnosis and treatment of coronary artery disease (CAD). Summary of the Invention [Problem to be solved by the invention]

[0005]

[0005] Embodiments of the present disclosure are systems, devices, and methods for overlaying physiological data, such as pressure data, onto a longitudinal view of endovascular data. Advantageously, this allows a user to more easily understand a patient's anatomy and determine the optimal treatment path. By providing views of the pressure data and endovascular imaging data at corresponding locations along a longitudinal view of the vessel to be treated, a physician can more quickly and accurately determine the appropriate treatment type, such as a stent, and the correct location for the treatment along the vessel, such as the proximal and distal landing zones of the stent. [Means for solving the problem]

[0006] The disclosed system performs tri-registration of three modalities: physiological data such as pressure data, intravascular imaging data, and extraluminal images such as X-ray angiographic images. The system co-registers physiological data from a pressure pullback procedure to an angiogram to establish a relationship between the pressure data and a position along the vessel of interest. The system then co-registers intravascular ultrasound (IVUS) data, including IVUS images from an IVUS imaging pullback procedure, to the same angiogram. The system then uses the position information of both pullbacks to display the IVUS imaging data and pressure data at the same position along either the angiographic image or a longitudinal view of the IVUS imaging data.

[0007] In an exemplary aspect, a system is provided that includes a processor circuit configured to communicate with an endoluminal imaging device and an endoluminal physiological measurement device, the processor circuit configured to receive a plurality of endoluminal images acquired by the endoluminal imaging device while the endoluminal imaging device is moved through a body cavity of a patient, receive a plurality of endoluminal physiological measurements acquired by the endoluminal physiological measurement device while the endoluminal physiological measurement device is moved through the body cavity, generate a longitudinal view of the body cavity based on the plurality of endoluminal images, generate a graphical representation based on the plurality of endoluminal physiological measurements, and output, on a display in communication with the processor circuit, a screen display including the longitudinal view of the body cavity and the graphical representation superimposed on the longitudinal view.

[0008] In one aspect, the processor circuit is further configured to co-register the plurality of endoluminal images to a first corresponding location along the body lumen and co-register the plurality of endoluminal physiological measurements to a second corresponding location along the body lumen, and the graphical representation is superimposed on the longitudinal view based on co-registering the plurality of endoluminal images and co-registering the plurality of endoluminal physiological measurements. In one aspect, the graphical representation is superimposed on the longitudinal view such that a location along the graphical representation corresponds to a location along the longitudinal view, and the location along the graphical representation and the location along the longitudinal view represent the same corresponding location along the body lumen. In one aspect, the processor circuit is further configured to identify a starting position of movement of the endoluminal imaging device and a length advanced by the endoluminal imaging device along the body lumen during movement of the endoluminal imaging device based on co-registering the plurality of endoluminal images, and to identify a starting position of movement of the physiological measurement device and a length advanced by the endoluminal imaging device along the body lumen during movement of the physiological measurement device, and the graphical representation is superimposed on the longitudinal view based on the starting position of movement of the endoluminal imaging device, the length advanced by the endoluminal imaging device along the body lumen, the starting position of movement of the physiological measurement device, and the length advanced by the physiologic measurement device along the body lumen. In one aspect, the processor circuit is further configured to determine an offset between the starting position of movement of the endoluminal imaging device and the starting position of movement of the physiological measurement device, and the graphical representation is superimposed on the longitudinal view based on the offset, the length advanced by the endoluminal imaging device along the body lumen, and the length advanced by the physiologic measurement device along the body lumen.In one aspect, the processor circuit is further configured to identify a start position of movement of the endoluminal imaging device and an end position of movement of the endoluminal imaging device based on coregistrating the plurality of endoluminal images, and to identify a start position of movement of the endoluminal imaging device and an end position of movement of the endoluminal physiologic measurement device, and the graphical representation is superimposed on the longitudinal view based on the start position of movement of the endoluminal imaging device, the end position of movement of the endoluminal imaging device, the start position of movement of the physiologic measurement device, and the end position of movement of the endoluminal physiologic measurement device. In one aspect, the graphical representation includes a plot based on the plurality of endoluminal physiologic measurements. In one aspect, the endoluminal physiologic measurement device comprises an intravascular pressure measuring device, and the plurality of endoluminal physiologic measurements include a plurality of intravascular pressure measurements, and the processor circuit is further configured to calculate a plurality of pressure ratios using the plurality of endoluminal physiologic measurements, and the plot based on the plurality of endoluminal physiologic measurements includes a plot of the plurality of pressure ratios. In one aspect, the processor circuit is configured to generate a further graphical representation based on the plurality of endoluminal physiological measurements, the screen display including the further graphical representation superimposed on the longitudinal view, the graphical representation including an adjusted plot based on the plurality of endoluminal physiological measurements, and the further graphical representation including a raw plot based on the plurality of endoluminal physiological measurements. In one aspect, the endoluminal physiological measurement device comprises an intravascular pressure measuring device, the plurality of endoluminal physiological measurements including a plurality of intravascular pressure measurements, the processor circuit further configured to calculate a plurality of pressure ratios using the plurality of endoluminal physiological measurements, the graphical representation including a plurality of shapes representing variations between the plurality of pressure ratios. In one aspect, the processor circuit receives user input from a user input device in communication with the processor circuit selecting a portion of the longitudinal view, and the screen display further includes an indicia identifying the portion of the longitudinal view superimposed on the longitudinal view. In one aspect, the longitudinal view of the body cavity includes an image-based longitudinal view including a plurality of endoluminal images.In one aspect, the processor circuit is configured to calculate a plurality of measurements related to the body cavity using the plurality of endoluminal images, and the longitudinal view of the body cavity includes a measurement-based longitudinal view based on the plurality of measurements. In one aspect, the screen display further includes an extraluminal image of the body cavity, an indication of a length advanced by the endoluminal imaging device during movement of the endoluminal imaging device, the indication of the length advanced by the endoluminal imaging device being superimposed on the extraluminal image, and an indication of a length advanced by the endoluminal physiologic measurement device during movement of the endoluminal imaging device, the indication of the length advanced by the endoluminal physiologic measurement device being superimposed on the extraluminal image. In one aspect, the screen display further includes an extraluminal image of the body cavity, and an endoluminal image of the plurality of endoluminal images.

[0009] In an exemplary aspect, a method is provided that includes receiving, by a processor circuit in communication with the endoluminal imaging device, a plurality of endoluminal images acquired by the endoluminal imaging device while the endoluminal imaging device is moving through a body cavity of a patient, receiving, by the processor circuit, a plurality of endoluminal physiological measurements acquired by the endoluminal physiological measurement device while the endoluminal physiological measurement device is moving through the body cavity, generating, by the processor circuit, a longitudinal view of the body cavity based on the plurality of endoluminal images, generating, by the processor circuit, a graphical representation based on the plurality of endoluminal physiological measurements, and outputting, on a display in communication with the processor circuit, a screen display including the longitudinal view of the body cavity and the graphical representation superimposed on the longitudinal view.

[0010] In an exemplary aspect, a system is provided that includes an intravascular imaging catheter, a pressure sensing guidewire, and a processor circuit configured to communicate with the intravascular imaging catheter and the pressure sensing guidewire, the processor circuit being configured to: receive a plurality of intravascular images acquired by the intravascular imaging catheter while the intravascular imaging catheter is moved through a patient's blood vessel, receive a plurality of intravascular pressure measurements acquired by the pressure sensing guidewire while the pressure sensing guidewire is moved through the blood vessel, generate a longitudinal view of the blood vessel based on the plurality of intravascular images, generate a graphical representation based on the plurality of intravascular pressure measurements, and output, on a display in communication with the processor circuit, a screen display including the longitudinal view of the blood vessel and the graphical representation superimposed on the longitudinal view.

[0011]

[0011] Further aspects, features, and advantages of the present disclosure will become apparent from the following detailed description.

[0012]

[0012] Exemplary embodiments of the present disclosure will now be described with reference to the accompanying drawings. [Brief explanation of the drawings]

[0013] [Figure 1A]

[0013] FIG. 1 is a schematic diagram of an intraluminal imaging system, a physiological measurement system, and an X-ray system according to aspects of the present disclosure. [Figure 1B]

[0014] 1 is a schematic diagram of an extraluminal imaging system according to aspects of the present disclosure. [Figure 1C]

[0015] 1 is a schematic diagram of an endoluminal imaging device according to aspects of the present disclosure. [Figure 2]

[0016] FIG. 1 is a schematic top view of an ultrasound imaging assembly in a flat configuration, according to aspects of the present disclosure. [Figure 3]

[0017] FIG. 1 is a schematic perspective view of an ultrasound imaging assembly in a wrapped configuration around a support member, according to aspects of the present disclosure. [Figure 4]

[0018] 1 is a schematic cross-sectional side view of an ultrasound imaging assembly according to aspects of the present disclosure. [Figure 5]

[0019] FIG. 2 is a schematic diagram of a processor circuit according to an aspect of the present disclosure. [Figure 6]

[0020] 1 is a schematic illustration of a region of a patient's vasculature, according to aspects of the present disclosure. [Figure 7]

[0021] 1 is a schematic diagram of the relationship between fluoroscopic images, pressure data, and a path defined by the motion of an intravascular device, according to an aspect of the present disclosure. [Figure 8]

[0022] 1 is a schematic diagram of the relationship between an X-ray fluoroscopic image, an intravascular ultrasound image, and a path defined by the motion of an intravascular device, according to an aspect of the present disclosure. [Figure 9]

[0023] FIG. 10 is a schematic diagram illustrating the relationship between an intravascular image co-registered to an extraluminal image, pressure data co-registered to the extraluminal image, and a longitudinal view based on the intravascular image and pressure data, according to aspects of the present disclosure. [Figure 10]

[0024] FIG. 1 is a schematic diagram of an image-based longitudinal view of a lumen with co-registered pressure data, according to aspects of the present disclosure. [Figure 11]

[0025] FIG. 1 is a schematic diagram of an image-based longitudinal view of a lumen with co-registered pressure data, according to aspects of the present disclosure. [Figure 12]

[0026] FIG. 10 is a schematic diagram of a measurement-based longitudinal view of a lumen with co-registered pressure data, according to aspects of the present disclosure. [Figure 13]

[0027] FIG. 1 is a schematic diagram of an image-based longitudinal view of a lumen with co-registered pressure data, according to aspects of the present disclosure. [Figure 14]

[0028] FIG. 1 is a schematic diagram of a graphical user interface according to an aspect of the present disclosure. [Figure 15]

[0029] FIG. 1 is a schematic diagram of a graphical user interface according to an aspect of the present disclosure. [Figure 16]

[0030] 1 is a flow diagram of a method for co-registering endoluminal physiological data to a longitudinal image of a body cavity, according to aspects of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0014]

[0031] To promote an understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the present disclosure is intended. Any changes and further modifications to the described devices, systems, and methods, and any further applications of the principles of the present disclosure, as would normally occur to one skilled in the art to which the present disclosure pertains, are fully contemplated and included herein. In particular, it is fully contemplated that features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. However, for the sake of brevity, multiple iterations of these combinations will not be described individually.

[0015]

[0032] FIG. 1A is a schematic diagram of an endoluminal imaging system, a physiological measurement system, and an X-ray system according to aspects of the present disclosure. In some embodiments, the physiological measurement system, the endoluminal imaging system, and the extraluminal imaging system include three separate systems, a physiological measurement system 101, an endoluminal imaging system 191, and an extraluminal imaging system 151, or a combination of these three systems. The physiological measurement system 101 acquires medical data related to a patient's body while the endoluminal device is positioned inside the patient's body. For example, the physiological measurement system 101 can control an endoluminal device to acquire endoluminal data inside the patient's body while the endoluminal device is inside the patient's body. The endoluminal imaging system 191 also acquires medical data related to the patient's body while the endoluminal device is positioned inside the patient's body. For example, the endoluminal imaging system 101 can control an endoluminal device to acquire endoluminal data inside the patient's body while the endoluminal device is inside the patient's body. The extraluminal imaging system 151 acquires medical data about the patient's body while the extraluminal imaging device 152 is positioned outside the patient. For example, the extraluminal imaging system 151 can control the extraluminal imaging device 152 to acquire extraluminal images of the interior of the patient's body while the extraluminal imaging device 152 is outside the patient's body.

[0016]

[0033] The physiological measurement system 101 is in communication with the extraluminal imaging system 151 through any suitable components. Such communication may be established through wired cables, wireless signals, or any other means. In addition, the physiological measurement system 101 may be in continuous or intermittent communication with the X-ray system 151. For example, before, after, or at some point during the examination, the two systems may temporarily communicate through wired cables, through wireless communication, or through any other suitable means. In addition, the physiological measurement system 101 receives 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, the patient's medical history or other patient information, or any suitable data or information. The X-ray imaging system 151 also receives any of these data from the physiological measurement system 101. 1, the physiological measurement system 101 and the X-ray imaging system 151 are in communication with the same control system 130. In this embodiment, both systems are in communication with the same shown display 132, processor 134, and communication interface 140, as well as any other components implemented within the control system 130.

[0017]

[0034] The endoluminal imaging system 191 is in communication with the extraluminal imaging system 151 through any suitable components. Such communication may be established through wired cables, wireless signals, or by any other means. In addition, the endoluminal imaging system 191 may be in continuous or intermittent communication with the X-ray system 151. For example, before, after, or at some point during the examination, the two systems may be in temporary communication through wired cables, through wireless communication, or through any other suitable means. In addition, the endoluminal imaging system 191 receives 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, the patient's medical history or other patient information, or any suitable data or information. The X-ray imaging system 151 also receives any of these data from the endoluminal imaging system 191. 1, the endoluminal imaging system 191 and the X-ray imaging system 151 are in communication with the same control system 130. In this embodiment, both systems are in communication with the same shown display 132, processor 134, and communication interface 140, as well as any other components implemented within the control system 130.

[0018]

[0035] The endoluminal imaging system 191 is in communication with the physiological measurement system 101 through any suitable components. Such communication may be established through a wired cable, through wireless signals, or by any other means. Additionally, the endoluminal imaging system 191 may be in continuous or intermittent communication with the physiological measurement system 101. For example, before, after, or at some point during the examination, the two systems may be in temporary communication through a wired cable, through wireless communication, or through any other suitable means. Additionally, the endoluminal imaging system 191 receives data from the physiological measurement system 101, such as pressure data, blood flow data, metrics calculated using the physiological measurement system 101, information regarding the date and time of the examination, the type and / or severity of the patient's condition or diagnosis, the patient's medical history or other patient information, or any suitable data or information. The physiological measurement system 101 also receives any of these data from the endoluminal imaging system 191. 1, the endoluminal imaging system 191 and the physiological measurement system 101 are in communication with the same control system 130. In this embodiment, both systems are in communication with the same shown display 132, processor 134, and communication interface 140, as well as any other components implemented within the control system 130.

[0019]

[0036] In some embodiments, system 100 does not include control system 130 in communication with physiological measurement system 101, endoluminal imaging system 191, and / or x-ray imaging system 151. Instead, system 100 includes separate control systems. For example, one control system is in communication with or part of physiological measurement system 101, one control system is in communication with or part of endoluminal imaging system 191, and an additional separate control system is in communication with or part of x-ray imaging system 151. In this embodiment, the separate control systems for physiological measurement system 101, endoluminal imaging system 191, and x-ray imaging system 151 are similar to control system 130. For example, each control system includes various components or systems, such as a communication interface, a processor, and / or a display. In this embodiment, either the control system for physiological measurement system 101, the control system for endoluminal imaging system 191, or the control system for extraluminal imaging system 151 performs any or all of the coregistration steps described in this disclosure. In some embodiments, one control system 130 is in communication with and configured to control both the endoluminal imaging system 191 and the physiological measurement system 101, while a separate control system 130 controls the extraluminal imaging system 151. In other embodiments, one control system 130 is in communication with and configured to control the endoluminal imaging system 191 and the extraluminal imaging system 151, while a separate control system 130 controls the physiological measurement system 101. In other embodiments, one control system 130 is in communication with and configured to control the physiological measurement system 101 and the extraluminal imaging system 151, while a separate control system 130 controls the endoluminal imaging system 191.

[0020]

[0037] The physiological measurement system 101 may be an invasive blood pressure or blood flow measurement system. In some cases, the physiological measurement system 101 may be a pressure ratio system, such as an instantaneous fractional flow reserve (iFR) system, a fractional flow reserve (FFR) system, or a Pd / Pa system. The intraluminal system 101 includes a pressure guidewire, such as a solid-core pressure wire. The pressure wire may include one or more features described in U.S. Pat. No. 5,715,827, entitled "Ultra Miniature Pressure Sensor and Guide Wire Using the Same and Method," issued on February 10, 1998; U.S. Pat. No. 8,277,386, entitled "Combination Sensor Guidewire and Methods of Use," issued on October 2, 2012; and U.S. Pat. No. 9,339,348, entitled "Devices, Systems, and Methods for Assessing a Vessel," issued on May 17, 2016, all of which are incorporated herein by reference in their entireties.

[0021]

[0038] Generally, a pressure sensing device is placed within a patient's body cavity. The pressure sensing device includes a pressure sensing guidewire 102 and a pressure sensing catheter 103. The pressure guidewire 102 includes a pressure sensor. The pressure sensing catheter also includes a pressure sensor. During a pressure pullback procedure, the pressure sensing catheter 103 is placed within the blood vessel at a location proximal to the area to be measured. The sensor of the pressure sensing guidewire 102 is also placed within the blood vessel at a location distal to the area to be measured. The pressure sensing catheter 103 remains substantially stationary during the pullback procedure. The pressure guidewire 102 is then pulled through the blood vessel from its distal location in a proximal direction. As the distal guidewire sensor moves through the lumen, both the sensor of the guidewire 102 and the sensor of the catheter 103 collect pressure measurements. Thus, for each position of the guidewire 102, two pressure measurements are collected: a distal guidewire pressure and a proximal catheter pressure. These two pressures are then compared to generate a pressure ratio. The pressure ratio may be fractional flow reserve (FFR), instantaneous fractional flow reserve (iFR), Pd / Pa, and / or any other suitable pressure ratio. For example, when two sensors are at substantially the same location within a blood vessel (e.g., after a pressure pullback procedure is completed), the pressures recorded by each sensor will be the same or substantially the same. Therefore, the resulting pressure ratio of these two pressures is 1.0 or close to 1.0. If the start of the pullback is distal to the occlusion within the blood vessel, the pressure measured by the distal guidewire sensor will be lower than the pressure measured by the proximal catheter sensor, resulting in a pressure ratio less than 1.0. The degree to which the pressure ratio is lower than 1.0 indicates the severity of the occlusion. As the distal guidewire sensor moves proximally along the guidewire within the blood vessel from its start location (distal within the blood vessel), the pressure measured by the distal guidewire sensor changes relative to the proximal, stationary catheter sensor.As a result, as the distal guidewire sensor moves, the ratio begins to increase such that at various locations along the vessel being analyzed, the pressure ratio corresponding to the distal guidewire pressure sensor location approaches 1.0 as the distal guidewire pressure sensor approaches the proximal catheter sensor.

[0022]

[0039] The communications interface 140 facilitates communication of measurements between the control system 130 and the physiological measurement system 101. In some embodiments, the communications interface 140 performs pre-processing of the data before relaying the data to the processor 134. In one embodiment, the communications interface 140 also provides high-voltage and low-voltage DC power to support operation of the devices in the physiological measurement system 101.

[0023]

[0040] The PIM 104 is configured to further facilitate communication between the physiological measurement system 101 and the control system 130. For example, the PIM 104 electrically couples the transmission line bundle to the communication interface 140 and physically couples any pressure sensing devices, including the pressure sensor guidewire 106 and / or the pressure sensing catheter 103, to the communication interface 140. In some embodiments, the communication interface 140 is a PIM.

[0024]

[0041] The hemodynamic system 105 includes various features of the physiological measurement system 101. For example, the hemodynamic system 105 includes a communication interface that facilitates communication between the pressure-sensing catheter 103 and the control system 130. In some embodiments, the hemodynamic system 105 is in communication with additional elements of the physiological measurement system 101, such as the pressure-sensing guidewire 102, or any other system or device. For example, the hemodynamic system 105 is in communication with an extraluminal imaging system, such as the extraluminal imaging system 151. The hemodynamic system 105 is in communication with electrocardiogram (ECG) electrodes and can provide a graphical display of the electrocardiogram of the patient's heart. The hemodynamic system 105 is in communication with a heart rate sensor and can provide a graphical display of the heart rate. The hemodynamic system 105 is in communication with an external blood pressure monitor (e.g., a sphygmomanometer, an inflatable cuff, and / or a pressure gauge) and can provide a graphical display of the systolic and diastolic blood pressure.

[0025]

[0042] In some embodiments, the intraluminal device is a pressure sensing device (e.g., a pressure sensing guidewire) that acquires intraluminal (e.g., intravascular) pressure data, and the physiological measurement system 101 is an intravascular pressure sensing system that determines a pressure ratio based on the pressure data, such as fractional flow reserve (FFR), instantaneous fractional flow reserve (iFR), and / or other suitable ratio between distal pressure and proximal / aortic pressure (Pd / Pa). In some embodiments, the intraluminal device 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 a flow-related value based on the pressure data, such as coronary flow reserve (CFR), flow velocity, flow rate, etc.

[0026]

[0043] 1B is a schematic diagram of an extraluminal imaging system according to aspects of the present disclosure. X-ray imaging system 151 includes an X-ray imaging apparatus or device 152 configured to perform X-ray imaging, angiography, fluoroscopy, radiography, and venography, among other imaging techniques. X-ray imaging system 151 can 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 X-ray device 152. X-ray imaging device 152 can be any suitable type of device, such as a stationary 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. X-ray imaging device 152 can also be any suitable mobile device. X-ray imaging device 152 is also in communication with control system 130. In some embodiments, X-ray system 151 includes a digital radiography device or any other suitable device.

[0027]

[0044] 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 are mounted at a distance from each other. An anatomical portion of a patient or object 180 is positioned between the X-ray source 160 and the X-ray detector 170. For example, an anatomical portion of the patient (including the blood vessel 120) may be positioned between the X-ray source 160 and the X-ray detector 170.

[0028]

[0045] The X-ray source 160 includes an X-ray tube adapted to generate X-rays. Some embodiments of the X-ray source 160 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 further includes a filament. The filament may be any suitable type or constructed from any suitable material, including tungsten or rhenium-tungsten, and is positioned within the recessed region of the cathode. One function of the cathode is to emit electrons from the high-voltage power supply and focus them to create a well-defined beam aimed at the anode. The anode, also constructed from any suitable material, is configured to create X-ray radiation from the electrons emitted from the cathode. Additionally, the anode dissipates heat generated during the process of generating X-ray radiation. The anode is shaped as a tilted disk and, in some embodiments, rotates via an electric motor. The cathode and anode of the X-ray source 160 are housed in an airtight enclosure, sometimes referred to as an envelope.

[0029]

[0046] In some embodiments, the x-ray source 160 includes a radiation object focus that affects the visibility of the image. The radiation object focus is selected by the user of the system 100 or the manufacturer of the system 100 based on characteristics such as blur, visibility, heat dissipation capabilities, or other characteristics. In some embodiments, the operator or user of the system 100 switches between different radiation object focuses provided in a point-of-care setting.

[0030]

[0047] The detector 170 is configured to acquire X-ray images and includes an input screen 174. The input screen 174 includes one or more intensifying screens configured to absorb X-ray energy and convert that energy to light. The light then exposes a film. The input screen 174 is used to convert X-ray energy to light in embodiments where the film is more sensitive to light than to X-ray radiation. Different types of intensifying screens within the image intensifier are selected depending on the area of ​​the patient being imaged, the image details, and / or the patient's exposure requirements, or any other factors. The intensifying screens are constructed from any suitable material, including barium lead sulfate, barium strontium sulfate, barium fluorochloride, yttrium oxysulfide, or any other suitable material. The input screen 374 is a fluorescent screen or a film positioned directly adjacent to the fluorescent screen. In some embodiments, the input screen 374 also includes a protective screen to shield circuitry or components within the detector 370 from the surrounding environment. In some embodiments, the X-ray detector 170 includes a flat panel detector (FPD). The detector 170 may be an indirect conversion FPD or a direct conversion FPD. The detector 170 may also include a charge coupled device (CCD). The X-ray detector 370 may also be referred to as an X-ray sensor.

[0031]

[0048] Object 180 is any suitable object to be imaged. In an exemplary embodiment, the object is an anatomical region of a patient. More specifically, the anatomical region to be imaged includes the patient's chest, abdomen, pelvic region, neck, legs, head, feet, areas with the cardiovascular system, or areas containing the peripheral vasculature, including various anatomical structures, such as, but not limited to, organs, tissues, blood vessels and blood, gases, or any other anatomical structure or object. In other embodiments, the object is or includes an artificial structure.

[0032]

[0049] In some embodiments, the X-ray imaging system 151 is configured to acquire X-ray images without contrast. In some embodiments, the X-ray imaging system 151 is configured to acquire X-ray images with contrast (e.g., angiograms or venograms). In such embodiments, a contrast agent or X-ray dye is introduced into the patient's anatomical region prior to imaging. The contrast agent is also referred to as a radiocontrast agent, contrast substance, contrast dye, or contrast medium. The contrast dye is any suitable material, chemical, or compound, and may be a liquid, powder, paste, tablet, or any other suitable form of contrast dye. For example, the contrast dye may be an iodine-based compound, a barium sulfate compound, a gadolinium-based compound, or any other suitable compound. The contrast agent is used to enhance the visibility of internal fluids or internal structures within the patient's anatomical region. The contrast agent absorbs external X-rays, resulting in reduced exposure to the X-ray detector 170.

[0033]

[0050] In some embodiments, the extraluminal imaging system 151 is any suitable extraluminal imaging device, such as a computed tomography (CT) or magnetic resonance imaging (MRI).

[0034]

[0051] When control system 130 is in communication with X-ray system 151, communications interface 140 facilitates the 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, as well as receiving data from X-ray device 152. In some embodiments, communications interface 140 performs pre-processing of the X-ray data before relaying the data to processor 134. In an example of such an embodiment, communications interface 140 performs data amplification, filtering, and / or aggregation. In one embodiment, communications interface 140 also provides high-voltage and low-voltage DC power to support operation of device 152, including circuitry therein.

[0035]

[0052] The processor 134 receives 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 region being 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 anatomical region to generate a venogram, the particular region of interest imaged is one or more blood vessels or other segments or portions of the human vascular system. The contrast agent identifies both natural and / or artificial fluid-filled structures, such as arteries or veins, of the patient's vascular system, including cardiovascular, peripheral, neurovascular, renal, and / or any other suitable lumen within the body. For example, the x-ray device 152 may be used to examine any number of anatomical locations and tissue types, including, but not limited to, all of the aforementioned organs, body fluids, or other structures or portions of the anatomical region. The x-ray device 152 may be used to examine artificial structures, such as any of the aforementioned structures, in addition to natural structures.

[0036]

[0053] The processor 134 is 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 patient history, patient records, IVUS imaging, pre-operative ultrasound imaging, pre-operative CT, or any other suitable data.

[0037]

[0054] 1C is a schematic diagram of an endoluminal imaging device 102 according to an embodiment of the present disclosure. FIG. 1C illustrates an embodiment of an endoluminal imaging system 191 including the endoluminal imaging device 102 and associated components. As discussed above, the endoluminal imaging system 191 is incorporated into various systems of the broader system 100. Additionally, the endoluminal imaging system 191 includes additional components other than those illustrated in FIG. 1C. In some embodiments, the endoluminal imaging device 102 is a catheter or a guidewire.

[0038]

[0055] The endoluminal imaging system 191 may be an ultrasound imaging system. In some cases, the endoluminal imaging system 191 may be an intravascular ultrasound (IVUS) imaging system. The endoluminal imaging system 191 includes an endoluminal imaging device 102, such as a catheter, guidewire, or guide catheter, in communication with a control system 130. The control system 130 includes, among other components, a display 132, a processor 134, and a communication interface 140. The endoluminal 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.

[0039]

[0056] Generally, 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 the surrounding medium, such as a blood vessel 120, or another body cavity surrounding the scanner assembly 110, and ultrasonic echo signals are received by the transducer array 124. In that regard, the device 102 may be sized, shaped, or configured to be placed within a patient's body cavity. The communications interface 140 transfers the received echo signals to a processor 134 of the control system 130, where an ultrasound image (including flow information, in some embodiments) is reconstructed and displayed on a display 132. The control system 130, including the processor 134, may be operable to facilitate the functionality of the IVUS imaging system 191 described herein. For example, the processor 134 may execute computer-readable instructions stored on a non-transitory, tangible, computer-readable medium.

[0040]

[0057] The communications interface 140 facilitates the communication of signals between the control 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 specific transducer array elements or acoustic elements to be used for transmission and reception, (2) providing transmit trigger signals to the integrated circuit controller chip included in the scanner assembly 110 to activate transmit circuitry and generate electrical pulses to excite the selected transducer array elements, and / or (3) accepting echo signals received from the selected transducer array elements and amplified via amplifiers included on the integrated circuit controller chip of the scanner assembly 110. In some embodiments, the communications interface 140 performs pre-processing of the echo data before relaying the data to the processor 134. In an example of such an embodiment, the communications interface 140 performs data amplification, filtering, and / or aggregation. In one embodiment, the communications 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.

[0041]

[0058] Processor 134 receives echo data from scanner assembly 110 via communications interface 140 and processes the data to reconstruct an image of tissue structures within the medium surrounding scanner assembly 110. Processor 134 outputs the image data so that an image of lumen 120, such as a cross-sectional image of blood vessel 120, is displayed on display 132. Lumen 120 represents both natural and artificial structures that are filled with or surrounded by fluid. Lumen 120 is within a patient's body. Lumen 120 is a blood vessel, such as an artery or vein, of the patient's vascular system, including cardiovascular, peripheral, neurovascular, renal, and / or any other suitable lumen within the body. For example, device 102 may be used to examine any number of anatomical locations and tissue types, including, but not limited to, organs including the liver, heart, kidneys, gallbladder, pancreas, lungs, ducts, intestines, brain, dural sac, spinal cord, and nervous system structures including peripheral nerves, urinary tract, blood valves, ventricles or other parts of the heart, and / or other systems of the body. In addition to natural structures, device 102 may be used to examine artificial structures, such as, but not limited to, heart valves, stents, shunts, filters, and other devices.

[0042]

[0059] In some embodiments, the IVUS device includes several features similar to those disclosed in conventional solid-state IVUS catheters, such as the EagleEye® catheter, Visions PV.014P RX catheter, Visions PV.018 catheter, Visions PV.035 catheter, and Pioneer Plus catheter, each available from Koninklijke Philips NV, and U.S. Pat. No. 7,846,191, the entire contents of which are incorporated herein by reference. 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, including one, two, three, four, five, six, seven, or more conductors. It should be understood that any suitable gauge wire can be used for the conductors. In one embodiment, the cable 112 includes a four-conductor transmission line configuration, for example, using 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.

[0043]

[0060] 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 is 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 to guide the device 102 into the blood vessel 120.

[0044]

[0061] In some embodiments, the intraluminal imaging device 102 acquires intravascular images of any suitable imaging modality, including optical coherence tomography (OCT) and intravascular photoacoustic (IVPA).

[0045]

[0062] FIG. 2 is a schematic top view of an ultrasound imaging assembly in a flat configuration according to an embodiment of the present disclosure. The flexible assembly 110 includes a transducer array 124 formed in a transducer region 204 and a transducer control logic die 206 (including die 206A and die 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 shown in a flat configuration in FIG. 2. While six control logic dies 206 are shown in FIG. 2, any number of control logic dies 206 may be used. For example, one, two, three, four, five, six, seven, eight, nine, ten, or more control logic dies 206 may be used.

[0046]

[0063] The flexible substrate 214, to which the transducer control logic die 206 and transducer elements 212 are attached, provides structural support and interconnects for electrical coupling. The flexible substrate 214 is constructed to include a film layer of a flexible polyimide material, such as KAPTON (a trademark of DuPont). Other suitable materials include polyester film, polyimide film, polyethylene naphthalate film, or polyetherimide film, liquid crystal polymer, other flexible printed semiconductor substrates, and products such as Upilex (a registered trademark of Ube Industries) and TEFLON (a registered trademark of EI du Pont). In its 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 optionally configured to be wrapped around a support member 230 (FIG. 3). Thus, the thickness of the film layer of the flexible substrate 214 is generally related to the degree of curvature of the final assembled flexible assembly 110. In some embodiments, the film layer is between 5 μm and 100 μm, and in some particular embodiments, between 5 μm and 25.1 μm, for example, 6 μm.

[0047]

[0064] The set of transducer control logic dies 206 is a non-limiting example of control circuitry. 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, control region 208, and transition region 210 may vary in different embodiments. 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 length 225 of the transducer region and the length 229 of the controller region, respectively.

[0048]

[0065] The control logic die 206 is not necessarily homogeneous. In some embodiments, a single controller is designated as the master control logic die 206A and includes the 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 logic die 206A includes control logic for decoding control signals received via the cable 112, transmitting control responses via the cable 112, amplifying echo signals, and / or transmitting echo signals via the cable 112. The remaining controllers are slave controllers 206B. The slave controllers 206B include control logic for driving the plurality of transducer elements 512 arranged on the transducer element 212 to emit ultrasonic signals and for selecting the transducer elements 212 to receive echoes. In the depicted 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 controller 206B, or drives a reduced set of transducer elements 212 compared to the slave controller 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.

[0049]

[0066] 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 a film layer that carry signals between the control logic die 206 and the transducer elements 212. Specifically, the conductive traces 216, which provide communication between the control logic die 206 and the transducer elements 212, extend along the flexible substrate 214 within 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 are deposited on the flexible substrate 214 by processes 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 adequate conductivity and resilience when the flexible substrate 214 is rolled. In that regard, an exemplary range for the thickness of 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. Furthermore, the width of the conductive traces 216 on the flexible substrate is determined by the width of the conductors 218 that are coupled to the traces or pads.

[0050]

[0067] The flexible substrate 214, in some embodiments, includes a conductor interface 220. The conductor interface 220 is located on the flexible substrate 214 at a location 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 may be a tab extending from the body of the flexible substrate 214. In that regard, the body of the flexible substrate 214 may 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 a proximal portion 222 of the flexible substrate 214. In other embodiments, the conductor interface 220 may be located in another portion of the flexible substrate 214, such as the distal portion 221, or the flexible substrate 214 may not have a conductor interface 220. The dimensions of tab or conductor interface 220, such as width 224, can be smaller than the dimensions of the main body of flexible substrate 214, such as width 226. In some embodiments, the substrate forming conductor interface 220 is made of the same material as flexible substrate 214 and / or is similarly flexible. In other embodiments, conductor interface 220 is made of a different material than flexible substrate 214 and / or is relatively more rigid than flexible substrate 214. For example, conductor interface 220 is made of a plastic, thermoplastic, polymer, rigid polymer, etc., including polyoxymethylene (e.g., DELRIN®), polyetheretherketone (PEEK), nylon, liquid crystal polymer (LCP), and / or other suitable materials.

[0051]

[0068] FIG. 3 is a schematic perspective view of an ultrasound imaging assembly in a configuration wrapped around a support member, according to aspects of the present disclosure. FIG. 3 shows a perspective view of the scanner assembly 110 in a wrapped configuration. In some cases, the flexible substrate 214 transitions from a planar configuration (FIG. 2) to a wrapped or more cylindrical configuration (FIG. 3). For example, in some embodiments, techniques disclosed in one or more of U.S. Pat. No. 6,776,763, entitled "ULTRASONIC TRANSDUCER ARRAY AND METHOD OF MANUFACTURING THE SAME," and U.S. Pat. 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.

[0052]

[0069] Depending on the application and embodiment of the invention of this disclosure, the transducer elements 212 are piezoelectric transducers, single crystal transducers, or PZT (lead zirconate titanate) transducers. In other embodiments, the transducer elements of the transducer array 124 are bending transducers, piezoelectric micromachined ultrasonic transducers (PMUTs), capacitive micromachined ultrasonic transducers (CMUTs), or any other suitable type of transducer element. In such embodiments, the transducer elements 212 comprise strips of semiconductor material or other suitable material that enable micromachining or similar methods of placing extremely small elements or circuits on a substrate.

[0053]

[0070] In some embodiments, the transducer elements 212 and the controller 206 may be arranged in an annular configuration, such as a circular configuration, or in a polygonal configuration around the longitudinal axis 250 of the support member 230. It should be understood that the longitudinal axis 250 of the support member 230 may also be referred to as the longitudinal axis of the scanner assembly 110, the flexible elongate member 121, or the device 102. For example, the cross-sectional profile 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, such as a shape based on the number of controllers or transducers, the flexibility of the controllers or transducers, etc. Some examples include a pentagon, hexagon, heptagon, octagon, nonagon, decagon, etc. In some examples, the transducer controller 206 is used to control the ultrasound transducers 512 of the transducer elements 212 to acquire imaging data related to the blood vessel 120.

[0054]

[0071] The support member 230 may sometimes be referred to as a unibody. The support member 230 may be constructed of a metallic material, such as stainless steel, or a non-metallic material, such as a plastic or polymer, as described in U.S. Provisional Patent 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 is constructed of 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 be tubular in shape and define a lumen 236 extending longitudinally thereof. 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 machined and / or electrochemically machined or laser machined, such as by removing material from a blank to form the support member 230, or may be formed, such as by an injection molding process or a micro-injection molding process.

[0055]

[0072] 4 is a schematic cross-sectional side view of an ultrasound imaging assembly according to aspects of the present disclosure. The endoluminal imaging device 102 includes a flexible substrate 214 and a support member 230 according to aspects of the present disclosure. The lumen 236 is connected to the inlet / outlet port 116 and is sized and shaped to accommodate the guidewire 118 (FIG. 1). In some embodiments, the support member 230 is integrally formed as a unitary structure, while in other embodiments, the support member 230 is formed from different components, such as ferrules and stands 242, 243, and 244, that are fixedly coupled to one another. In some cases, the support member 230 and / or one or more components thereof are fully integrated with the inner member 256. In some cases, the inner member 256 and the support member 230 are joined as one piece, such as in the case of a polymeric support member.

[0056]

[0073] The distal, central, and proximal portions of support member 230 are provided with vertically extending stands 242, 243, and 244, respectively. Stands 242, 243, and 244 elevate and support the distal, central, and proximal portions of flexible substrate 214. In that regard, a portion of flexible substrate 214, such as transducer portion 204 (or transducer region 204), may be spaced apart from the central body portion of support member 230 extending between stands 242, 243, and 244. Stands 242, 243, and 244 may have the same or different outer diameters. For example, distal stand 242 may have a larger or smaller outer diameter than central stand 243 and / or proximal stand 244, and may also have special features for rotational alignment and control of tip placement and connection.

[0057]

[0074] To improve acoustic performance, the cavity between the transducer array 212 and the surface of the support member 230 is 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 passages 235 in the stand 242 or through additional recesses described in more detail below. The backing material 246 serves to attenuate ultrasonic energy emitted by the transducer array 212 that propagates in undesired inward directions.

[0058]

[0075] The cavity between the circuit controller chip 206 and the surface of the support member 230 is filled with an underfill material 247. The underfill material 247 is an adhesive (e.g., epoxy) that provides structural support to the circuit controller chip 206 and / or the flexible substrate 214. Furthermore, the underfill material 247 may be any suitable material.

[0059]

[0076] 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. Acoustic backing material 246 and / or underfill material 247 may be introduced through the cavity (before the inner member 256 extends through the lumen of the unibody during the assembly process). In some embodiments, suction is applied through the passage 235 of one of the stands 242, 244 or to any other suitable recess, and liquid backing material 246 is supplied between the flexible substrate 214 and the support member 230 through the passage 235 of the other of the stands 242, 244 or to any other suitable recess. The backing material may be cured so that it is allowed to solidify and harden. In various embodiments, the support member 230 includes more than three stands 242, 243, and 244, only one or two of the stands 242, 243, 244, or no stands at all. In this regard, the support member 230 may have a larger diameter distal portion 262 and / or a larger diameter proximal portion 264 sized and shaped to lift and support the distal and / or proximal portions of the flexible substrate 214 .

[0060]

[0077] In some embodiments, the support member 230 can be substantially cylindrical. Other shapes of the support member 230 are contemplated, including geometric, non-geometric, symmetrical, and asymmetrical cross-sectional profiles. The term shape of the support member 230, as used herein, refers to the cross-sectional profile of the support member 230. In other embodiments, different portions of the support member 230 can have various shapes. For example, the proximal portion 264 can have an outer diameter that is larger than the outer diameter of the distal portion 262 or the outer diameter of the central portion extending between the distal portion 262 and the proximal portion 264. In some embodiments, the inner diameter of the support member 230 (e.g., the diameter of the lumen 236) can increase or decrease as the outer diameter changes. In other embodiments, the inner diameter of the support member 230 remains the same as the outer diameter changes.

[0061]

[0078] 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 elongated 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 member 252 is disposed around 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 is housed within the distal end of the flexible substrate 214 in a rolled configuration. In some embodiments, a gap exists between the flexible substrate 214 and the tip member 252. Distal member 252 may be the distal-most component of endoluminal imaging device 102. Distal tip member 252 is a flexible polymer component that defines the distal-most end of imaging device 102. Distal tip member 252 further defines a lumen that communicates with lumen 236 defined by support member 230. Guidewire 118 extends through lumen 236 and the lumen defined by tip member 252.

[0062]

[0079] One or more adhesives may be disposed between various components in the distal portion of the endoluminal 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 bonded to one another via an adhesive. In other words, the adhesive may contact, 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, among other components.

[0063]

[0080] FIG. 5 is a schematic diagram of a processor circuit according to an embodiment of the present disclosure. The processor circuit 510 may be implemented in the control system 130, the endoluminal imaging system 191, the physiological measurement system 101, and / or the X-ray imaging system 151 of FIG. 1A, or in any other suitable location. In one example, the processor circuit 510 is in communication with the endoluminal imaging device 102, the X-ray imaging device 152, the pressure-sensing guidewire and / or catheter described above, and / or the display 132 in the system 100. The processor circuit 510 includes the processor 134 and / or the communication interface 140 (FIG. 1A). The one or more processor circuits 510 are configured to perform the operations described herein. As shown, the processor circuit 510 includes a processor 560, a memory 564, and a communication module 568. These elements are in communication with each other directly or indirectly, for example, via one or more buses.

[0064]

[0081] Processor 560 may include a CPU, GPU, DSP, application specific integrated circuit (ASIC), controller, FPGA, another 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 conjunction with a DSP core, or any other such configuration.

[0065]

[0082] 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 different types of memory. In one embodiment, the memory 564 includes a non-transitory computer-readable medium. The memory 564 stores instructions 566. The instructions 566 include instructions that, when executed by the processor 560, cause the processor 560 to perform 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" refer to one or more programs, routines, subroutines, functions, procedures, etc. "Instructions" and "code" include a single computer-readable statement or many computer-readable statements.

[0066]

[0083] The communications module 568 may include any electronic and / or logical circuitry for facilitating the direct or indirect communication of data between the processor circuit 510, the probe 110, and / or the display 132. In that 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, the probe 110 (FIG. 1C), and / or the host 130 (FIG. 1A).

[0067]

[0084] Figure 6 is a schematic diagram of a region 600 of a patient's vasculature, according to an embodiment of the present disclosure. Shown in Figure 6 is a diagram of a blood vessel 690 measured using the physiological measurement system 101 and the intraluminal imaging system 191. The physiological measurement procedure may be completed before or after the intraluminal imaging procedure.

[0068]

[0085] In one example, a physiological measurement procedure is performed. During this procedure, a pressure sensing device of the physiological measurement system 101 is placed within a blood vessel 690. For example, a pressure sensing catheter is placed at a position 611 within the blood vessel 690. A distal pressure sensor of a pressure sensing guidewire is placed at a starting position 610, as indicated by point 602. During the pressure sensing procedure, the distal pressure sensor of the pressure sensing guidewire moves within the blood vessel 690 from position 610 to position 611. As the guidewire is pulled from position 610 to position 611, the distal sensor acquires pressure measurements. A proximal pressure sensor of the stationary catheter, positioned at position 611, also collects pressure measurements. As described with reference to FIG. 7 , for each position along the blood vessel 690 to which the distal sensor of the guidewire has advanced, a pressure ratio is calculated and associated with that position along the blood vessel 690.

[0069]

[0086] 6, a path 603 is shown adjacent to blood vessel 690. Path 603 illustrates the shape and length of the path of the distal pressure sensor of the guidewire due to the pullback, except that the distal pressure sensor of the guidewire is advanced within blood vessel 690 rather than next to the lumen. This path 603 may be located within blood vessel 690 or anywhere else.

[0070]

[0087] An endoluminal imaging procedure is performed using, for example, an IVUS imaging system including an intravascular ultrasound (IVUS) imaging device or catheter, such as device 102 ( FIG. 1C ). During this procedure, IVUS imaging device 102 of endoluminal imaging system 191 is positioned within blood vessel 690. For example, device 102 is positioned at position 612 within blood vessel 690. This position is the starting position of device 102, as indicated by point 604. During the endoluminal imaging procedure, device 102 moves from position 612 to position 613 within blood vessel 690. As endoluminal imaging device 102 is pulled from position 612 to position 613, device 102 acquires intravascular ultrasound data. The endoluminal ultrasound data acquired at particular positions along a path 605 traveled by endoluminal imaging device 102 is received by control system 130 and used to generate radial cross-sectional images (e.g., IVUS images) of blood vessel 690 at that position. As will be described with reference to FIG. 8, for each location along the blood vessel 690 that the device 102 passes through, an IVUS image is generated and associated with that location along the blood vessel 690 .

[0071]

[0088] 6, a path 605 is shown adjacent to a blood vessel 690. The path 605 illustrates the shape and length of the path of the endoluminal imaging device 102 of the pullback endoluminal imaging system 191, except that the device 102 travels within the blood vessel 690 rather than next to the lumen. This path 605 may be located within the blood vessel 690 or anywhere else.

[0072]

[0089] As shown in FIG. 6, the starting location of the pressure sensor on the guidewire (e.g., location 610) is not the same as the starting location of the endoluminal imaging device 102 (e.g., location 612). For example, location 612, which corresponds to the starting location of the IVUS imaging device 102, may be distal (as shown in FIG. 6) or proximal to the starting location of the pressure-sensing guidewire. Similarly, the ending location of the pressure guidewire (e.g., location 611) is different from the ending location of the device 102 (e.g., location 613). As a result, there are regions of the blood vessel 690 that are only imaged by the imaging device 102 (e.g., region 614 in the example shown in FIG. 6) or measured only by the pressure-sensing guidewire (e.g., region 615 in the example shown in FIG. 6).

[0073]

[0090] In some embodiments, the beginning of the pressure sensor on the guidewire is at the same location as the beginning of the endoluminal imaging device 102. Similarly, the end of the pressure guidewire is at the same location as the end of the device 102. As a result, all areas of the blood vessel 690 imaged by the imaging device 102 are also measured by the pressure-sensing guidewire.

[0074]

[0091] 7 and 8, aspects of co-registering pressure data and intravascular images to extraluminal images (e.g., angiographic images) are disclosed. In some embodiments, the system uses physiologic co-registration to an angiogram as a first step to establish the length of the physiologic pullback. The system then co-registers the IVUS pullback to the same angiogram that establishes that length. The system then uses these pullback lengths and their starting locations to co-register the physiologic data to a calibrated longitudinal cross-section of the IVUS pullback. In some embodiments, the registration of the physiologic data, endovascular data, and angiographic images is referred to as tri-registration. In some embodiments, tri-registration refers to the correlation of three separate imaging modalities, each of which is displayed simultaneously.

[0075]

[0092] 7 is a schematic diagram illustrating the relationship between a fluoroscopic image 710, pressure data 730, and a path 740 defined by the movement of an intravascular device, according to an embodiment of the present disclosure. FIG. 7 illustrates a method for co-registering physiological data 730, including pressure ratio data or iFR measurements, with corresponding locations on one or more fluoroscopic images 710 of the same region of a patient's anatomy.

[0076]

[0093] Various aspects of co-registering physiological data with extraluminal images include one or more features described in U.S. Patent Application Publication No. 2006 / 0241465, entitled "Vascular Image Co-registration," filed January 11, 2006, which is incorporated herein by reference in its entirety.

[0077]

[0094] While the physician is performing a pullback with the pressure sensing device, for example, while a pressure sensing guidewire is moved through a blood vessel at the anatomical location, the patient's anatomical location is imaged by an X-ray device. The pressure sensing guidewire is substantially similar to the pressure sensing guidewire described with reference to FIG. 1A . The X-ray device used to acquire fluoroscopic image 710 is substantially similar to X-ray device 152 of FIG. 1B . In some embodiments, fluoroscopic image 710 is acquired without the presence of contrast agent in the patient's vasculature. Such an embodiment is illustrated by fluoroscopic image 710 of FIG. 7 . In other embodiments, contrast agent is present in the patient's vasculature. In that regard, fluoroscopic image 710 may alternatively be an angiographic image or any suitable type of extraluminal image. A radiopaque portion of intravascular device 720 is visible in fluoroscopic image 710. Fluoroscopic image 710 corresponds to a continuous image stream of fluoroscopic images and is acquired when the patient's anatomical location is exposed to a reduced dose of X-ray radiation. It should be noted that fluoroscopic image 710 is acquired with x-ray source 160 and x-ray detector 170 positioned at any suitable angle relative to the patient's anatomy, as indicated by angle 790.

[0078]

[0095] Intravascular device 720 may be any suitable intravascular device. In the example shown, device 720 includes a pressure-sensing guidewire. As the pressure-sensing guidewire moves through the patient's vasculature, an X-ray imaging system acquires multiple fluoroscopic images 710 showing radiopaque portions of the pressure-sensing guidewire. In this manner, each fluoroscopic image 710 shown in FIG. 7 depicts the pressure-sensing guidewire positioned at various locations such that processor circuit 510 (FIG. 5) can track the position of the pressure-sensing guidewire throughout the endovascular coregistration procedure.

[0079]

[0096] As the pressure sensing guidewire is pulled through the patient's vasculature, the pressure sensing guidewire acquires pressure data 730. In one example, the pressure data 730 shown in Figure 7 is an iFR measurement. However, the pressure data may be any suitable data, including FFR data, iFR data, blood pressure, any other measurement or metric related to blood flow, or other physiological data acquired during guidewire pullback.

[0080]

[0097] As the physician pulls the pressure-sensing guidewire through the patient's vasculature, each iFR data point 730 acquired by the pressure-sensing guidewire is associated with a location within the fluoroscopic image 710, as indicated by arrow 761. For example, the first pressure data measurement 730 shown in FIG. 7 is associated with a location within the first fluoroscopic image 710. The first iFR measurement 730 is the pressure ratio acquired by the pressure-sensing guidewire (in conjunction with the proximal pressure-sensing catheter) at a location within the vasculature as depicted in the first fluoroscopic image 710 and as indicated by the radiopaque portion of the pressure-sensing guidewire within the image 710. Similarly, additional iFR measurements 730 are associated with additional fluoroscopic images 710 showing the pressure-sensing guidewire in a new position within the image 710, and so on. The processor circuit 510 identifies the location of the pressure-sensing guidewire within each acquired x-ray image 710. The processor circuit 510 identifies the location of the pressure-sensing guidewire by any suitable method. For example, the processor circuit 510 performs various image processing techniques, such as edge identification of radiopaque markers, pixel-by-pixel analysis to identify transitions between light and dark pixels, filtering, or any other suitable technique for identifying the location of the pressure-sensing guidewire. In some embodiments, the processor circuit uses various artificial intelligence methods, including deep learning techniques such as neural networks, or any other suitable techniques, to identify the location of the pressure-sensing guidewire within the x-ray image 710.

[0081]

[0098] During device pullback, any suitable number of iFR data points 730 are acquired and any suitable number of fluoroscopic images 710 are acquired. In some embodiments, there is a one-to-one ratio of fluoroscopic images 710 and iFR data 730. In other embodiments, there is a different number of fluoroscopic images 710 and iFR data 730. The process of co-registering iFR data 730 and / or endovascular data 830 (described with reference to FIG. 8 ) with one or more x-ray images includes some features similar to those described in U.S. Patent No. 7,930,014, entitled “VASCULAR IMAGE CO-REGISTRATION,” filed January 11, 2006, which is incorporated herein by reference in its entirety. The coregistration process also includes some features similar to those described in U.S. Pat. Nos. 8,290,228, 8,463,007, 8,670,603, 8,693,756, 8,781,193, 8,855,744, and 10,076,301, all of which are incorporated herein by reference in their entireties.

[0082]

[0099] After the pullback procedure is completed, or during the pullback procedure, system 100 generates a fluoroscopy-based 2D path 740 defined by the position of the pressure-sensing guidewire within fluoroscopic image 710. The various positions of the pressure-sensing guidewire during pullback, as shown in fluoroscopic image 710, define two-dimensional path 740, as indicated by arrow 760. Fluoroscopy-based 2D path 740 reflects the path of the pressure-sensing guidewire as it moves through the patient's vasculature, as observed from angle 790 by x-ray imaging device 152. Fluoroscopy-based 2D path 740 defines a path measured by the x-ray device that acquired fluoroscopic image 710 and therefore shows the path from the same angle 790 as when the fluoroscopic image was acquired. In other words, 2D path 740 represents a projection of the 3D path followed by the device onto the imaging plane at imaging angle 790. In some embodiments, path 740 is determined by an average of the detected positions of the pressure-sensing guidewire within fluoroscopic image 710. For example, the path 740 does not exactly coincide with the guidewire in any fluoroscopic image 710 selected for presentation. In some embodiments, the path 740 is not displayed to the user. For example, each pressure data 730 is associated with a specific coordinate in the image 711. In this manner, the pressure data 730 is directly co-registered to the image 711. The group of all coordinates associated with the pressure data 730 defines the path 740. In this manner, the iFR data is directly associated with a portion or location within the roadmap image 711.

[0083]

[0100] As indicated by arrow 762, the two-dimensional path 740 is generated based on the fluoroscopic images 710, such that each location along the two-dimensional path 740 is associated with one or more fluoroscopic images 710. As an example, at location 741 along the path 740, a first fluoroscopic image 710 depicts a pressure-sensing guidewire at that same location 741. Additionally, because a correspondence has been established between the fluoroscopic images 710 and the iFR data 730, as indicated by arrow 761, the iFR data 730, such as the first iFR measurement shown, is also associated with the location 741 along the path 740, as indicated by arrow 763.

[0084]

[0101] Finally, the path 740 generated based on the position of the pressure-sensing guidewire in the fluoroscopic image 710 is superimposed on any suitable fluoroscopic image 711 (e.g., one of the fluoroscopic images 710 in the fluoroscopic image stream). In this manner, any position along the path 740 displayed on the fluoroscopic image 711 is associated with iFR data, such as iFR measurement 730, as indicated by arrow 764. For example, the first pressure data 730 shown in FIG. 7 is acquired simultaneously with the first fluoroscopic image 710 shown, and the two images are associated with each other, as indicated by arrow 761. In that case, the fluoroscopic image 710 indicates the position of the pressure-sensing guidewire along the path 740, as indicated by arrow 762, and thus the pressure data 730 is associated with the position 741 along the path 740, as indicated by arrow 763. Finally, by superimposing the path 740 on the associated data on the fluoroscopic image 711, the pressure data 730 is associated with the position in the fluoroscopic image 710 at which the pressure data 730 was acquired. The path 740 itself may or may not be displayed on the image 711 .

[0085]

[0102] In some embodiments, the co-registered iFR data is associated with an X-ray image acquired with contrast (where the blood vessels are visible) so that the location at which the iFR data is acquired is known relative to the location along the blood vessel.

[0086]

[0103] 8 is a schematic diagram illustrating the relationship between an X-ray fluoroscopic image 810, an intravascular ultrasound image 830, and a path 840 defined by the movement of an intravascular device, according to an embodiment of the present disclosure. FIG. 8 illustrates a method for co-registering endovascular data 830 including an intravascular image with corresponding locations on one or more fluoroscopic images 810 of the same region of a patient's anatomy. The embodiment for co-registering endovascular data 830 including an IVUS image is similar in concept to that described with reference to FIG. 7.

[0087]

[0104] Specifically, while a physician performs a pullback with intravascular device 820, for example, while intravascular device 820 is moved through a blood vessel at the anatomical site, the patient's anatomical site is imaged by an X-ray device. The intravascular device is substantially similar to intravascular device 102 described with reference to FIG. 1C. The X-ray device used to acquire fluoroscopic image 810 is substantially similar to X-ray device 152 of FIG. 1B. In some embodiments, fluoroscopic image 810 is acquired without the presence of contrast agent in the patient's vasculature. Such an embodiment is illustrated by fluoroscopic image 810 of FIG. 8. In other embodiments, contrast agent is present in the patient's vasculature. In that regard, fluoroscopic image 810 may alternatively be an angiographic image or any suitable type of extraluminal image. Radiopaque portions of intravascular device 820 are visible in fluoroscopic image 810. Fluoroscopic image 810 corresponds to a continuous image stream of fluoroscopic images and is acquired when the patient's anatomical site is exposed to a reduced dose of X-ray radiation. It should be noted that fluoroscopic image 810 is acquired with x-ray source 160 and x-ray detector 170 positioned at any suitable angle relative to the patient's anatomy, as indicated by angle 890.

[0088]

[0105] Intravascular device 820 may be any suitable intravascular device. As intravascular device 820 moves through the patient's vasculature, an x-ray imaging system acquires multiple fluoroscopic images 810 showing radiopaque portions of intravascular device 820. In this manner, each fluoroscopic image 810 shown in FIG. 8 depicts intravascular device 820 positioned at a different location such that a processor circuit can track the position of intravascular device 820 over time.

[0089]

[0106] As the intravascular device 820 is pulled through the patient's vasculature, the intravascular device 820 can acquire intravascular data 830. In one example, the intravascular data 830 shown in Figure 8 is an IVUS image. However, the intravascular data may be any suitable data, including an IVUS image, an OCT image, an intravascular photoacoustic (IVPA) image, any other measurement or metric related to the luminal structure, or other physiological data acquired during pullback of the intravascular device.

[0090]

[0107] As the physician pulls the pressure-sensing guidewire through the patient's vasculature, each intravascular data point 830 acquired by the intravascular device 820 is associated with a location within the patient's anatomy in the fluoroscopic image 810, as indicated by arrow 861. For example, the first IVUS image 830 shown in FIG. 8 is associated with the first fluoroscopic image 810. The first IVUS image 830 is an image acquired with the intravascular device 820 at a position within the vasculature as depicted in the first fluoroscopic image 810 and as indicated by the intravascular device 820 in the image 810. Similarly, a further IVUS image 830 is associated with a further fluoroscopic image 810 showing the intravascular device 820 in a new position within the image 810, and so on. The processor circuit identifies the location of the intravascular device 820 within each acquired x-ray image 810 by any suitable method. For example, the processor circuitry performs various image processing techniques, such as edge identification of radiopaque markers, pixel-by-pixel analysis to identify transitions between bright and dark pixels, filtering, or any other suitable technique for locating the imaging device 820. In some embodiments, the processor circuitry uses various artificial intelligence methods, including deep learning techniques such as neural networks, or any other suitable techniques, to identify the location of the imaging device 820 within the x-ray image 810.

[0091]

[0108] During device pullback, any suitable number of IVUS images or other endovascular data points 830 are acquired, and any suitable number of fluoroscopic images 810 are acquired. In some embodiments, there is a one-to-one ratio of fluoroscopic images 810 and endovascular data 830. In other embodiments, there is a different number of fluoroscopic images 810 and / or endovascular data 830.

[0092]

[0109] Additionally, system 100 generates a fluoroscopy-based 2D path 840 defined by the position of intravascular device 820 within fluoroscopic image 810. The various positions of intravascular device 820 during pullback shown in fluoroscopic image 810 define two-dimensional path 840, as indicated by arrow 860. Fluoroscopy-based 2D path 840 reflects the path of one or more radiopaque portions of intravascular device 820 as it moves through the patient's vasculature, as observed from angle 890 by x-ray imaging device 152. Fluoroscopy-based 2D path 840 defines the path measured by the x-ray device that acquired fluoroscopic image 810 and thus shows the path from the same angle 890 as when the fluoroscopic image was acquired. In other words, 2D path 840 represents the 3D path followed by the device, projected onto the imaging plane at imaging angle 890. In some embodiments, the path 840 is determined by an average of the detected positions of the intravascular device 820 in the fluoroscopic images 810. For example, the path 840 does not exactly coincide with the guidewire in any of the fluoroscopic images 810 selected for presentation. However, it should be noted that the imaging catheter 102 is positioned to move along the guidewire, as described with reference to FIGS. 1-4 . In some embodiments, the path 840 is not displayed to the user. For example, each IVUS image 830 is associated with specific coordinates in the image 811. In this manner, the pressure data 830 is directly co-registered to the image 811. The group of all coordinates associated with the pressure data 830 defines the path 840. In this manner, the IVUS images are directly associated with portions or locations within the roadmap image 811.

[0093]

[0110] As indicated by arrow 862, two-dimensional path 840 is generated based on fluoroscopic images 810, such that each position along two-dimensional path 840 is associated with one or more fluoroscopic images 810. As an example, at position 841 along path 840, a first fluoroscopic image 810 depicts intravascular device 820 at that same position 841. Additionally, because a correspondence between fluoroscopic images 810 and endovascular data 830 is also established as indicated by arrow 861, endovascular data 830, such as the illustrated IVUS image, is also associated with position 841 along path 840, as indicated by arrow 863.

[0094]

[0111] Finally, the path 840 generated based on the position of the intravascular device 820 in the fluoroscopic image 810 is superimposed on any suitable fluoroscopic image 811 (e.g., one of the fluoroscopic images 810 in the fluoroscopic image stream). In this manner, any position along the path 840 displayed on the fluoroscopic image 811 is associated with IVUS data, such as IVUS image 830, as indicated by arrow 864. For example, the IVUS image 830 shown in FIG. 8 is acquired simultaneously with the fluoroscopic image 810 shown, and the two images are associated with each other, as indicated by arrow 861. In that case, the fluoroscopic image 810 indicates the position of the intravascular device 820 along the path 840, as indicated by arrow 862, and thus the IVUS image 830 is associated with the position 841 along the path 840, as indicated by arrow 863. Finally, by superimposing the path 840 on the associated data on the fluoroscopic image 811, the IVUS image 830 is associated with the position in the fluoroscopic image 810 at which the IVUS image 830 was acquired. The path 840 itself may or may not be displayed on the image 811 .

[0095]

[0112] In the illustrated embodiment of Figure 8, the co-registered IVUS image is associated with one of the fluoroscopic images acquired without contrast, so that the location at which the IVUS image is acquired is known relative to the location along the guidewire. In other embodiments, the co-registered IVUS image is associated with an X-ray image acquired with contrast (in which the blood vessels are visible), so that the location at which the IVUS image is acquired is known relative to the location along the blood vessel.

[0096]

[0113] 9 is a schematic diagram illustrating the relationship between an intravascular image co-registered with an extraluminal image, pressure data co-registered with the extraluminal image, and longitudinal views based on the intravascular image and pressure data, according to an embodiment of the present disclosure. Specifically, FIG. 9 illustrates the relationship between a roadmap fluoroscopic image 711 and co-registered iFR data 730 (FIG. 7) and a roadmap fluoroscopic image 811 and co-registered IVUS imaging data 830 (FIG. 8). Thus, FIG. 9 illustrates a method for co-registering iFR data 730 and IVUS images 830 of the same region of a patient's anatomy.

[0097]

[0114] In some embodiments, the physiological data is overlaid on the IVUS cross-sectional image (e.g., ILD). Coregistration of the physiological data with the IVUS data allows the user to better understand the context of the entire imaged and / or measured segment of the vessel, as well as the physiological data associated with a particular IVUS frame. Coregistration is a differentiating factor in the diagnosis and treatment of coronary artery disease (CAD). Coregistration of imaging data and physiological data to an angiogram and / or to each other not only allows physicians to more easily understand the anatomy of a patient's coronary arteries, but also allows them to identify optimal treatment pathways.

[0098]

[0115] The path 740 described with reference to FIG. 7 includes position data and iFR data. For example, the path 740 associates iFR data (e.g., data 730 in FIG. 7) with a position along a blood vessel (e.g., blood vessel 690 in FIG. 6). For example, each iFR datum 730 corresponds to one position coordinate that, together with the other iFR data position coordinates, defines the path 740. The position coordinate of the first received iFR data corresponds to the start position of the pressure guidewire and is the start position of the path 740. The last received iFR data corresponds to the end position. The length along the blood vessel and / or guidewire between the start and end positions defines the length of the path 740. In one embodiment, each iFR datum is associated with two-dimensional coordinates specifying a position within the roadmap image 711. In another embodiment, each iFR datum is associated with a one-dimensional coordinate of a distance measurement from the start position. In this embodiment, the start position corresponds to the origin or zero distance.

[0099]

[0116] Path 840, as described with reference to FIG. 8, includes similar position data and IVUS imaging data. For example, path 840 associates IVUS image data (e.g., IVUS data 830 in FIG. 8) with a position along a blood vessel (e.g., blood vessel 690 in FIG. 6). For example, each IVUS image 830 corresponds to one position coordinate that, together with the other IVUS image position coordinates, defines path 840. Similar to path 740, the position coordinate of the first received IVUS image corresponds to the start position of the imaging device and is the start position of path 840. The last received IVUS image corresponds to the end position. The length along the blood vessel and / or guidewire between the start and end positions defines the length of path 840. In one embodiment, each IVUS image is associated with two-dimensional coordinates specifying a position within roadmap image 811. In another embodiment, each IVUS image is associated with a one-dimensional coordinate of a distance measurement from the start position. In this embodiment, the start position corresponds to the origin or zero distance.

[0100]

[0117] In embodiments in which the iFR data and the IVUS image are each associated with two-dimensional coordinates that identify a location within roadmap image 711 or roadmap image 811, respectively, the iFR data and the IVUS image acquired at the same location along the vessel are co-registered based on having the same or substantially similar two-dimensional coordinates. In this embodiment, roadmap image 711 and roadmap image 811 are the same image or substantially the same image.

[0101]

[0118] In an embodiment in which the iFR data and the IVUS image are each associated with a one-dimensional length that identifies the distance from their respective starting positions, the distance between the starting position of the iFR path 740 and the starting position of the IVUS imaging path 840 is determined. This distance is used as an offset to match the one-dimensional distance coordinate of the iFR data to the same position as the IVUS image. In this embodiment, the roadmap image 711 and the roadmap image 811 may be the same image or different images.

[0102]

[0119] The relationship between path 740 and the associated iFR data and a location along the patient's vessel, and the relationship between path 840 and the associated IVUS image data and a location along the same vessel, results in the iFR data and IVUS image data being displayed together at the same location along the vessel, as shown by the longitudinal view 910 of the body lumen and the superimposed data shown in Figure 9. The longitudinal view may be referred to as an image longitudinal display (ILD) or in-line digital (ILD) view.

[0103]

[0120] The acquired IVUS images are used to create the ILD 910. In that regard, the IVUS images are a tomographic or radial cross-sectional view of the blood vessel. The ILD 910 provides a longitudinal cross-sectional view of the blood vessel. The ILD 910 is a stack of IVUS images acquired at various positions along the blood vessel, such that the longitudinal view of the ILD 910 is perpendicular to the radial cross-sectional view of the IVUS images. In such an embodiment, the ILD 910 represents the length of the blood vessel, with each individual IVUS image being a single radial cross-sectional image at a given position along the length. In another embodiment, the ILD 910 is a stack of IVUS images acquired over time during an imaging procedure, with the length of the ILD 910 representing the time or duration of the imaging procedure. The ILD 910 is generated and displayed in real time or near real time during the pullback procedure. As additional IVUS images are acquired, they are added to the ILD 910. For example, at some point during the pullback procedure, the ILD 910 shown in FIG. 9 is partially complete. In some embodiments, the processor circuit generates an illustration of a longitudinal view of the vessel being imaged based on the received IVUS image, for example, the illustration is a stylized version of the vessel, e.g., solid lines indicating the lumen and vessel boundaries, rather than displaying actual vessel image data as in ILD910.

[0104]

[0121] As an example, indicator 912 identifies a location along a blood vessel as shown on ILD 910. This indicator 912 simultaneously corresponds to location 741 along path 740 and the same location 841 along path 840. As a result, an IVUS image acquired at location 841 is displayed at the location of indicator 912 as part of ILD 910, as indicated by arrow 961. Similarly, the iFR value associated with location 741 is superimposed on ILD 910 at the same location as indicator 912, as indicated by arrow 963.

[0105]

[0122] All acquired iFR values ​​associated with path 740 are overlaid on the ILD 910. An example of how the iFR values ​​are displayed to the user is shown by line 914. Plots are overlaid on the ILD 910 as shown by indicator 918 and indicator 920. For example, the minimum iFR value corresponds to indicator 920 and the maximum value corresponds to indicator 918. The vertical position of line 914 on the ILD 910 corresponds to the iFR value being some value between the minimum and maximum values. For example, at the most distal position along the ILD 910, the pressure data will be at a minimum, as shown by line 914 being located near the bottom of the ILD 910 and in line with or at the same vertical position as minimum value 920. Similarly, at the proximal end, the pressure data will be at a maximum value. This is shown by line 914 being at the top of the ILD 910 and in line with or at the same vertical position as maximum value 918. In some embodiments, the user selects a portion of line 914 and / or line 916 (described below), and system 100 displays to the user the iFR value associated with the selected location. System 100 also displays the iFR value at the location of indicator 912.

[0106]

[0123] System 100 performs any suitable processing of the iFR data or IVUS imaging data. For example, the system's processor circuit 510 may perform averaging, smoothing, segmenting, grouping, or any other suitable data processing before or after the data is displayed to the user. In one example, line 914 shown in FIG. 9 represents processed iFR data. Circuit 510 is also configured to simultaneously display raw iFR data. The raw iFR data is indicated by a line. The visual representation of the raw iFR data and the processed iFR data may be visually distinguished in any manner, such as by different colors, patterns, transparency, or other forms of emphasis or differentiation. Processor circuit 510 may indicate line 914 and line 916 simultaneously or separately.

[0107]

[0124] The processor circuit 510 is configured to perform length measurements of any device or any anatomical structure or feature in the extraluminal image. Length determinations include, for example, the length of a pullback path (e.g., the pullback path of an intravascular imaging device and / or a pressure sensing device), the length of a recommended stent, the length between points of interest, or any other length. The length determination is performed automatically by the processor circuit 510 or in response to user input. The length determination is based at least in part on the radiopaque section of the pressure sensing wire. For example, the radiopaque section of the guidewire is a known length (e.g., 3 cm). The system uses this length as a reference length to determine the length of any other feature in the image. A similar method is applied using the radiopaque portion of an IVUS imaging device. For example, in some embodiments, the transducer section of an intravascular imaging device is constructed from a radiopaque material and is of known dimensions. Additional markers of known length are also present along with the length comparisons performed by the processor circuit 510.

[0108]

[0125] In some embodiments, errors exist in the IVUS pullback position data. Additionally, errors exist in the position data along the physiologic pullback. Because the IVUS position data and physiologic data are co-registered to the extraluminal image, which is co-registered with one another, errors in both the IVUS pullback position information and the physiologic pullback information are stacked. To correlate these stacked errors, the system generates and displays error bars associated with either the iFR data (point 1114 or lines 914 and 916) or the IVUS data. These error bars are displayed along the ILD or extraluminal image to help the user easily understand the presence and amount of error associated with the displayed position data.

[0109]

[0126] FIG. 10 is a schematic diagram of an image-based longitudinal view of a lumen with co-registered pressure data, according to aspects of the present disclosure. FIG. 10 shows a depiction of a stent 1010 along the ILD. At this point, the stent 1010 may be overlaid on the ILD 910. A stent placement recommendation is automatically made by the processor circuit 510. The recommendation includes stent type, stent length, stent diameter, proximal and distal stent landing zones, and the number of recommended stents, or any other suitable stent parameters. In some embodiments, the stent recommendation is based on any of the iFR data, IVUS imaging data, the location of imaged / measured side branches of the vessel, the distance between consecutive stents or stents in series, or any other factor. Aspects of the automatic stent recommendation include features described in U.S. Provisional Patent Application No. 63 / 288,554, filed December 11, 2021, entitled "AUTOMATIC SEGMENTATION AND TREATMENT PLANNING FOR A VESSEL WITH COREGISTRATION OF PHYSIOLOGY DATA AND EXTRALUMINAL DATA," which is incorporated herein by reference in its entirety. In some embodiments, the representation of the stent 1010 represents a virtual stent or a planned stent. In some embodiments, the representation of the virtual stent 1010 can be manually positioned by user input via a user input device (e.g., a touchscreen display, a mouse / keyboard, etc.). For example, the processor circuit 510 is configured to receive user input providing instructions for adjusting the stent's position, length, etc. The user determines the placement of the stent or other characteristics of the stent based on the iFR data and / or IVUS imaging data depicted by line 914. In other embodiments, the graphical element 1010 shown overlaid on the ILD 910 is not a stent but any other suitable treatment. For example, graphical element 1010 may represent an angioplasty device, a balloon, an atherectomy device, or any other therapeutic device.

[0110]

[0127] In some embodiments, line 914 is alternatively referred to as a trend line. In some embodiments, line 914 is based on physiological data measured by a physiological measurement device. In one example, line 914 is based on pressure measurements within a blood vessel. In some embodiments, line 914 indicates an iFR value. In some embodiments, the iFR value corresponding to line 914 is based on pressure measurements obtained by a distal pressure guidewire and simultaneously obtained by a proximal pressure sensor, such as a pressure sensor disposed on a guide catheter. In some embodiments, the pressure device measuring the iFR value is positioned in the renal artery, a pressure sensor disposed on the pressure guidewire receives measurements in the renal artery, and a pressure sensor disposed on a guide catheter positioned in the aorta receives measurements of pressure in the aorta. In some embodiments, the proximal or distal pressure measurements are taken by an aortic catheter. Thus, the value of line 914 corresponds to the pressure ratio between any two of these pressure sensors.

[0111]

[0128] FIG. 10 also shows region 1014. As shown in FIG. 10, line 914 corresponding to the iFR data terminates at a location proximal to region 1014 because region 1014 was an area imaged with the IVUS imaging device but not measured with the pressure-sensing guidewire. As a result, region 1014 represents an imaging-based segmentation of the ILD but does not include overlaid iFR data. Thus, in the example shown in FIG. 10, region 1014 corresponds to region 614 shown and described with reference to FIG. 6.

[0112]

[0129] Also shown in Figure 10 is region 1015. The image data included as part of ILD 910 is shown to end distal to region 1015 because region 1015 was a region measured with the pressure-sensing guidewire but not imaged with the IVUS device. As a result, region 1015 represents the iFR data of lines 914 and / or 916, but does not represent image-based data corresponding to data acquired with the IVUS imaging device. Thus, in the example shown in Figure 10, region 1015 corresponds to region 615 shown and described with reference to Figure 6.

[0113]

[0130] As indicated by regions 1014 and / or 1015, one or more offsets occur depending on the region of the vessel measured by the intravascular device or the pressure pullback device alone. As a result, the system performs various calibration procedures to ensure that the location of the intravascular image data matches the location of the corresponding pressure data. For example, the system performs calibration to ensure that the pressure data is co-registered with the corresponding IVUS data. In some cases, as shown in the upper right corner of ILD 910 (e.g., region 1015), the physiologic pullback length (e.g., path 603) is longer than the IVUS pullback length (e.g., path 605). Both the physiologic pullback and IVUS pullback paths begin at reference points that can be offset or calibrated so that the location along the physiologic pullback matches the location along the IVUS pullback. As an example, an endoluminal image (e.g., an IVUS image) is correlated with a first corresponding location along the patient's body lumen by any of the co-registration steps described above. The endoluminal physiological measurements (e.g., iFR measurements) are similarly correlated with second corresponding locations along the same body lumen of the patient. In this example, one, some, or all of the first locations of the endoluminal images are the same or different from one, some, or all of the second locations of the endoluminal physiological measurements. In some embodiments, the endoluminal images and the physiological measurements correspond to the same locations along the body lumen.

[0114]

[0131] 11 is a schematic illustration of an image-based longitudinal view 1110 of a lumen with co-registered pressure data, according to an embodiment of the present disclosure. FIG. 11 illustrates an additional method of displaying iFR data superimposed on an ILD (e.g., ILD 1110). As shown in FIG. 11, a plurality of points 1114 are superimposed on the ILD 1110. The ILD 1110 is substantially similar to the ILD 910 shown previously.

[0115]

[0132] 11 , each point 1114 corresponds to a change in pressure ratio (e.g., iFR). For example, in some embodiments, the presence of one point 1114 at a given location corresponds to a change in pressure ratio of 0.01. The points 1114 are associated with any suitable change in pressure ratio other than 0.01, with this value determined by the processor 510 or a user of the system 100. The points 1114 shown superimposed on the ILD 1110 may be positioned in any suitable location, such as on the ILD 1110, adjacent to the ILD 1110, or superimposed in any other location.

[0116]

[0133] It is further noted that the dots 1114 may be of any suitable appearance. In particular, the dots 1114 are shown and described in this disclosure as round dots for educational purposes only. For example, the dots 1114 may be of any suitable shape, pattern, size, or any other visual appearance.

[0117]

[0134] 12 is a schematic illustration of a measurement-based longitudinal view 1210 of a lumen with co-registered pressure data, according to an embodiment of the present disclosure. FIG. 12 illustrates an additional method of displaying iFR data superimposed on an ILD (e.g., ILD 1210). As shown in FIG. 12, a plurality of points 1114 are superimposed on the ILD 1210.

[0118]

[0135] In some embodiments, the ILD 1210 includes a stylized ILD. In particular, a stylized ILD is an ILD that is generated based on lumen measurements rather than based on IVUS images. As an example, referring to FIG. 11 , the ILD 1110 is primarily based on IVUS images, while the stylized ILD 1210 is based on endoluminal measurements of the imaged vessel and / or lumen. For example, the stylized ILD 1210 includes line 1212 and line 1214. Line 1212 corresponds to the vessel wall of the imaged vessel. For example, the processor circuit 510 automatically identifies the vessel wall in each IVUS image received during the imaging procedure. The processor circuit 510 determines the distance from the imaging catheter to the vessel wall in each direction around the catheter in each IVUS image. Based on these measurements (e.g., the identification of the vessel wall and the distance from the vessel wall to the catheter), the processor circuit determines the average diameter of the vessel in each IVUS image at each location along the vessel. These averaged diameters are associated with each IVUS image and associated with each location along path 840 (FIG. 8). Lines 1212 are then generated as symmetric lines about a centerline along ILD 1210 and spaced apart from one another based on the average diameter of the vessel wall at that location. This allows a user of system 100 to easily view the vessel wall along the imaged segment of the vessel by clearly identifying and presenting a simplified depiction of the vessel wall. In some embodiments, ILD 1210 is referred to as a vessel reconstruction.

[0119]

[0136] Similarly, a stylized depiction of the lumen is identified and illustrated by line 1214. Line 1214 corresponds to the lumen boundary of the imaged blood vessel. For example, processor circuit 510 automatically identifies the lumen boundary in each received IVUS image during the imaging procedure. Processor circuit 510 further determines the distance from the imaging catheter to the lumen boundary in each direction around the catheter in each IVUS image. Based on these measurements (e.g., identification of the lumen boundary and the distance from the lumen boundary to the catheter), processor circuit determines an average diameter of the lumen boundary for each IVUS image. These averaged diameters are associated with each IVUS image and associated with each position along path 840 ( FIG. 8 ). Lines 1214 are then generated as symmetric lines centered about a centerline along ILD 1210 and spaced apart from one another based on the average diameter of the lumen boundary at that position. This allows a user of system 100 to easily view the lumen boundary along the imaged segment of the blood vessel by clearly identifying the boundary and presenting a simplified depiction.

[0120]

[0137] Examples of boundary detection, image processing, image analysis, and / or pattern recognition include U.S. Patent No. 6,200,268 entitled "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 entitled "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. 6,381,350 entitled "INTRAVASCULAR ULTRASONIC ANALYSIS USING ACTIVE CONTOUR METHOD AND SYSTEM," issued on July 11, 2006, to Anuja Nair, D. Geoffrey Vince, Jon D. Klingensmith, and Barry D. Kuban as inventors. No. 7,074,188 entitled "NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD," issued on February 13, 2007, to D. Geoffrey Vince, Anuja Nair, and Jon D. Klingensmith as inventors; U.S. Patent No. 7,175,597 entitled "NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD," issued on May 8, 2007, to Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince as inventors; U.S. Patent No. 7,215,802 entitled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," issued on April 15, 2008, to Jon D. Klingensmith, D. Geoffrey Vince, Anuja Nair, and Barry D. Kuban as inventors; and U.S. Patent No. 7,215,802 entitled "SYSTEM AND METHOD FOR IDENTIFYING A VASCULAR BORDER DETECTION," issued on April 15, 2008, to Jon D. Klingensmith, D. Geoffrey Vince, Anuja Nair, and Barry D. Kuban as inventors. No. 7,359,554 entitled "BORDER" and issued on December 9, 2008 to Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D.No. 7,463,759 entitled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," issued to Geoffrey Vince as inventor, the teachings of which are incorporated herein by reference in their entireties.

[0121]

[0138] Lines 1212 and 1214 may be displayed to the user simultaneously or separately, as shown in Figure 12. When displayed simultaneously, the user can easily distinguish the diameter of the vessel wall compared to the diameter of the luminal boundary at any location along the imaged vessel, allowing for easy and quick assessment of the degree of stenosis within the imaged vessel. Lines 1212 and 1214 may be distinguished from one another using any of the methods described herein.

[0122]

[0139] As shown in Figure 12, points 1114 are further superimposed on the stylized ILD 1210. The points 1114 are the same as those described with reference to Figure 11. The combination of the stylized representation of the vessel wall (e.g., line 1212), the stylized representation of the luminal boundary (e.g., line 1214), and the points 1114 representing the changes in pressure ratio along the vessel provides the user of the system 100 with an accurate and concise view of the level of stenosis within the vessel. Using this data, the user can quickly and accurately identify the location of the vessel requiring treatment and identify what type of treatment is required.

[0123]

[0140] 12, the delineation of the vessel wall by line 1212 includes discontinuities in line 1212. These discontinuities correspond to side branches of the vessel. The locations of these side branches are either automatically determined by the processor circuit 510 or identified by a user of the system in either the extraluminal image, the IVUS image, or the displayed ILD.

[0124]

[0141] Further, it should be noted that the pressure data may be displayed in any manner in conjunction with the ILD 1210. As an example, lines similar to lines 914 and / or 916 may be superimposed on the measurement-based ILD 1210. In this manner, the plot style for displaying pressure ratio data shown and described with reference to Figures 9 and 10, including lines 914 and 916 and indices 918 and 920, may also be superimposed on the stylized ILD shown in Figure 12. For example, the stylized ILD 1210 may include point 1114 and / or lines 914 and 916 and associated indices 918 and 920. Any of the ILDs described herein may include any of the forms of pressure change data described or shown herein.

[0125]

[0142] FIG. 13 is a schematic illustration of an image-based longitudinal view 1310 of a lumen with coregistrated pressure data, according to aspects of the present disclosure. FIG. 13 shows an additional ILD 1310. The ILD 1310 depicts multiple stents. For example, as shown in FIG. 13, stent 1315 is shown superimposed on ILD 1310, and additional stent 1320 is shown superimposed on ILD 1310. In some embodiments, stent 1315 and stent 1320 are virtual stents. For example, stents 1315 and 1320 shown along 1310 are recommended locations for stents to be placed within a vessel.

[0126]

[0143] In some embodiments, stent 1315 corresponds to a virtual stent automatically recommended by processor circuitry 510 according to the principles outlined with reference to FIG. 10. Stent 1320 corresponds to a virtual stent manually placed by a user of the system. System 100 may provide the user with a graphical user interface that allows the user to, for example, select any type or size of stent and place that stent anywhere along ILD 1310. In this manner, the user plans the deployment of the stent using ILD 1310 (or any other ILD described herein).

[0127]

[0144] In some embodiments, after a virtual stent (e.g., stent 1010, 1315, or 1320) is recommended, selected, designated, or displayed, the system predicts virtual changes in the pressure data. For example, the system generates modified versions of lines 914 and 916 ( FIG. 9 ) and / or point 1114 ( FIG. 11 ) that indicate the predicted changes in the pressure data. Aspects of predicting changes in the pressure data of a virtual stent include various features, including those described in previously incorporated U.S. Provisional Patent Application No. 63 / 288,554, filed December 11, 2021, entitled “AUTOMATIC SEGMENTATION AND TREATMENT PLANNING FOR A VESSEL WITH COREGISTRATION OF PHYSIOLOGY DATA AND EXTRALUMINAL DATA.” In some embodiments, the predicted modified pressure data is displayed simultaneously with the pre-processing of the pressure data (e.g., lines 914 and 916 or point 1114). In some embodiments, the predicted modified pressure data is displayed separately from the pre-processing data.

[0128]

[0145] 14 is a schematic diagram of a graphical user interface 1400 according to an embodiment of the present disclosure. The graphical user interface 1400 is displayed to a user after an IVUS pullback and an endoluminal physiological measurement pullback have been performed and the IVUS image and physiological measurements have been co-registered to a position along a longitudinal view (e.g., ILD 1450) and / or an extraluminal image (e.g., X-ray image 1410).

[0129]

[0146] The processor circuit 510 is configured to co-register any endoluminal data (including IVUS images or iFR pressure ratio data) to a path (e.g., path 740 and / or path 840). For example, the IVUS imaging data and / or physiological data are associated with a position along the path. When the path is overlaid on the extraluminal image, the endoluminal data is displayed corresponding to a position in the extraluminal image, indicating at which position along the vessel indicated by the path the endoluminal data was acquired. As previously described, the endoluminal physiological data is overlaid on a longitudinal view of the body lumen. As shown in FIG. 14 , both the extraluminal image with the co-registered endoluminal data and the longitudinal view with the co-registered physiological data are displayed within the same screen display.

[0130]

[0147] As an example, graphical user interface 1400 provides an X-ray image 1410, an IVUS image 1430, physiological data 1490, and a longitudinal view 1450 of an imaged vessel. X-ray image 1410 includes a depiction of a path 1440. Path 1440 is similar to path 740 in FIG. 7 and / or path 840 in FIG. 8 . In some embodiments, path 1440 is a path corresponding to the movement of an intravascular imaging catheter. Path 1440 is superimposed on image 1410 to identify the location of the imaged vessel. As shown in FIG. 14 and described in further detail with reference to FIG. 15 , various indicia related to the co-registered endoluminal data are displayed along or adjacent to this path 1440.

[0131]

[0148] As an example, iFR data 1490 is co-registered to path 1440. For example, iFR data is received by processor circuit 510 during iFR pullback while an extraluminal image (e.g., image 710 of FIG. 7 ) is also received. Once the iFR data is acquired and associated with a location within the extraluminal image, the iFR data is identified with a location along path 1440. As an example, indicator 1422 is provided along path 1440. Indicator 1422 corresponds to a location along path 1440 where iFR data 1490, such as an iFR estimated metric, was acquired. Similarly, indicator 1494 is provided along path 1440 within image 1410. Indicator 1494 identifies a distal location where iFR data 1490 was acquired, such as a distal iFR value displayed as part of data 1490.

[0132]

[0149] Also shown within graphical user interface 1400 is IVUS image 1430. In that regard, multiple IVUS images (including image 1430) may be co-registered to path 1440. IVUS image 1430 is an IVUS image acquired at a location identified by indicator 1422. Alternatively, IVUS image 1430 is an IVUS image acquired at a location identified by indicator 1494. In some embodiments, IVUS image 1430 includes boundary 1432. This boundary is identified automatically by processor circuit 510 or by a user of the system. In some embodiments, boundary 1432 is a lumen boundary, a vessel boundary, a stent boundary, or other boundary within the image.

[0133]

[0150] Examples of boundary detection, image processing, image analysis, and / or pattern recognition include U.S. Patent No. 6,200,268 entitled "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 entitled "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. 6,381,350 entitled "INTRAVASCULAR ULTRASONIC ANALYSIS USING ACTIVE CONTOUR METHOD AND SYSTEM," issued on July 11, 2006, to Anuja Nair, D. Geoffrey Vince, Jon D. Klingensmith, and Barry D. Kuban as inventors. No. 7,074,188 entitled "NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD," issued on February 13, 2007, to D. Geoffrey Vince, Anuja Nair, and Jon D. Klingensmith as inventors; U.S. Patent No. 7,175,597 entitled "NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD," issued on May 8, 2007, to Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince as inventors; U.S. Patent No. 7,215,802 entitled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," issued on April 15, 2008, to Jon D. Klingensmith, D. Geoffrey Vince, Anuja Nair, and Barry D. Kuban as inventors; and U.S. Patent No. 7,215,802 entitled "SYSTEM AND METHOD FOR IDENTIFYING A VASCULAR BORDER DETECTION," issued on April 15, 2008, to Jon D. Klingensmith, D. Geoffrey Vince, Anuja Nair, and Barry D. Kuban as inventors. No. 7,359,554 entitled "BORDER" and issued on December 9, 2008 to Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D.No. 7,463,759 entitled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," issued to Geoffrey Vince as inventor, the teachings of which are incorporated herein by reference in their entirety.

[0134]

[0151] Interface 1400 also depicts metrics 1434. The metrics 1434 are associated with the displayed IVUS image 1430, and in particular with boundary 1432. For example, processor circuit 510 automatically calculates various metrics 1434 associated with boundary 1432. For example, processor circuit 510 identifies the cross-sectional area of ​​boundary 1432. The circuitry may also identify the minimum diameter of the boundary, the maximum diameter of the boundary, or any other measurement or metric associated with boundary 1432 or other aspect of image 1430.

[0135]

[0152] In some embodiments, a longitudinal view 140 is also displayed. The longitudinal image 1450 is referred to as an in-line digital (ILD) display or intravascular longitudinal display (ILD) 1450. IVUS images acquired during an intravascular ultrasound imaging procedure, such as during IVUS pullback, are used to create the ILD 1450. In that regard, the IVUS images are tomographic or radial cross-sectional views of the vessel. The ILD 1450 provides a longitudinal cross-sectional 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 embodiments, the ILD 1450 represents the length of the vessel, with each IVUS image being a single radial cross-sectional image at a given position along the length. In another embodiment, the ILD 1450 is a stack of IVUS images acquired over time during the imaging procedure, with the length of the ILD 1450 representing the time or duration of the imaging procedure. The ILD 1450 is generated and displayed in real time or near real time during the pullback procedure. As additional IVUS images are acquired, they are added to the ILD 1450. For example, at some point during the pullback procedure, the ILD 1450 shown in FIG. 14 is partially complete. In some embodiments, the processor circuit generates an illustration of a longitudinal view of the vessel being imaged based on the received IVUS images. For example, rather than displaying actual vessel image data, the illustration is a stylized version of the vessel, e.g., a luminal boundary and a solid line indicating the vessel boundary. As shown in FIG. 11 , the ILD 1450 represents a stylized ILD showing a luminal boundary 1156 extending as a solid line across the ILD 1450. The location of the luminal boundary 1156 is symmetrically arranged around a central axis and is positioned according to the calculated luminal diameter in each corresponding IVUS image.

[0136]

[0153] The ILD 1450 includes a representation of the iFR data 1492 , various length measurements 1462 , indices 1452 and 1456 that identify the start and end of the length measurements, and a bookmark identifier 1454 .

[0137]

[0154] In some embodiments, the iFR data 1492 is the same iFR data used to populate the described metrics 1490. As shown in the ILD 1450, and because the ILD 1450 is generated based on IVUS data, when two endoluminal procedures (e.g., IVUS data and physiologic data) are performed and co-registered to the same path (e.g., path 1440), the same IVUS data and physiologic data are co-registered to each other, as indicated by the iFR data 1492 shown at a location along the ILD 1450. The iFR data 1492 is similar to the line 914 described with reference to FIG. 10 . The ILD 1450 further includes iFR data 1493. In some embodiments, the iFR data 1493 corresponds to raw iFR data, and the iFR data 1492 corresponds to processed iFR data. The iFR data 1493 is similar to the line 916 described with reference to FIG. 10 .

[0138]

[0155] The ILD 1450 includes additional or alternative physiological measurement data other than the iFR data 1492 and 1493. For example, the physiological data overlaid on the ILD 1450 includes points similar to the points 1114 shown and described with reference to Figures 11 and 12. Additionally, the ILD 1450 may be an image-based longitudinal view of the lumen, as shown in Figure 14, or a measurement-based longitudinal view similar to the longitudinal view 1210 shown in Figure 12.

[0139]

[0156] The length measurements along the ILD 1450 are generated by a user of the system 100 and / or automatically by the processor circuitry 510. For example, a user selects various locations along the ILD 1450, and the processor circuitry calculates the length measurements corresponding to the selected locations. These various length measurements are displayed as metrics 1460 near the ILD 1450. In some embodiments, the length measurements are distinguished from one another by labels, colors, patterns, highlighting, or other visual features.

[0140]

[0157] Indicators 1452 and 1456 are user-selected locations along ILD 1450. In some embodiments, the indicators are automatically selected. By way of example, indicators 1452 and 1456 identify the start and end locations of length measurements. In some embodiments, indicators 1452 and 1456 correspond to the distal and proximal landing zones of a stent being considered by a physician. The iFR estimates in physiological data 1490 are predicted iFR values ​​based on indicators 1452 and 1456 with the proposed stent deployed in the vessel. In some embodiments, corresponding indicators are displayed at corresponding locations along path 1440 in image 1410.

[0141]

[0158] In some embodiments, one or more bookmarks 1454 are also included along the ILD 1450. These bookmarks 1454 correspond to similar bookmarks at corresponding locations along the path 1440 of the image 1410.

[0142]

[0159] An indicator 1470 is provided superimposed on the x-ray image 1410 in the screen display 1400. The indicator 1470 indicates to the user that the x-ray image is a zero contrast image frame.

[0143]

[0160] 15 is a schematic illustration of a graphical user interface 1500 according to an embodiment of the present disclosure. The graphical user interface 1500 includes an extraluminal image 1510, an IVUS image 1530, and a longitudinal view 1550.

[0144]

[0161] Extraluminal image 1510 is an X-ray image. Image 1510 is an image acquired with or without the introduction of contrast into the patient's vasculature. In some embodiments, X-ray image 1510 shows the same view of the blood vessels shown in IVUS image 1530 and longitudinal view 1550. Image 1510 includes a roadmap 1512 and a plurality of points 1514. Roadmap 1512 corresponds to a position within image 1510 to which the IVUS imaging device has advanced. Roadmap 1512 is similar to any of the roadmaps described herein, including, for example, roadmap 740 of FIG. 7 and / or roadmap 840 of FIG. 8. In some embodiments, a position along roadmap 1512 corresponds to a position within longitudinal view 1550. For example, distal position 1516 along roadmap 1512 corresponds to distal position 1553 in longitudinal view 1550. In this example, location 1516 of x-ray image 1510 and location 1556 of longitudinal view 1550 correspond to the same location within the patient's body cavity.

[0145]

[0162] In some implementations, multiple points 1514 correspond to locations where physiological measurements, such as pressure measurements, were received. As an example, point 1514 in image 1510 corresponds to a single location where a physiological measurement was obtained. In some embodiments, the locations of points 1514 in image 1510 are aligned with roadmap 1512. In other embodiments, the locations of points 1514 are not aligned with roadmap 1512. As shown in FIG. 15 , some regions of a blood vessel are imaged by an intravascular imaging device but not by a physiological measurement device. In some examples, some regions of a blood vessel are measured by a physiological measurement device but not by an intravascular imaging device. As an example, such a region is indicated by region 1518 in image 1510. For example, along region 1518, there is a point 1514 corresponding to a physiological measurement, but there is no roadmap 1512 corresponding to an intravascular imaging device.

[0146]

[0163] In some embodiments, point 1514 on image 1510 alternatively corresponds to the location where the IVUS image was acquired. In such embodiments, line 1512 corresponds to the path of the physiological measurement device during the pullback procedure.

[0147]

[0164] In some embodiments, the spacing between the dots 1514 indicates to a user the speed at which a device, such as a physiological measurement device, is progressing through a blood vessel. For example, a larger spacing between adjacent dots 1514 corresponds to a faster speed. Similarly, a smaller spacing between adjacent dots 1514 corresponds to a slower speed of the device. In some embodiments, a larger spacing corresponds to a slower speed and a smaller spacing corresponds to a faster speed.

[0148]

[0165] As shown in FIG. 15 , indicator 1522 identifies a location along path 1512 that corresponds to IVUS image 1530. Specifically, indicator 1522 identifies the location along path 1512 where IVUS image 1530 was acquired. An additional indicator 1524 is shown near indicator 1522. Indicator 1524 identifies for the user an iFR value that corresponds to the same location as indicator 1522. In some embodiments, indicator 1524 displays any other physiological measurement. An intravascular pressure data indicator 1582 is also located within image 1510. Indicator 1582 corresponds to a pressure measurement taken along the length of the blood vessel. Indicator 1582 corresponds to either or both of ILD 1550 data 1592 and / or 1593. In some embodiments, indicator 1582 indicates a change in pressure along the blood vessel. For example, the presence of a single indicator 1582 corresponds to a predetermined change in pressure, such as a change in iFR of 0.01. Indicators 1582 are displayed adjacent to and perpendicular to the blood vessels in image 1510 .

[0149]

[0166] Additionally, additional data 1590 is shown overlaid on image 1510. Data 1590 corresponds to physiological measurements taken within a blood vessel. In some embodiments, data 1590 includes averages, maximums, minimums, or any other values ​​corresponding to physiological measurements. In some embodiments, data 1590 also includes data corresponding to IVUS measurements. For example, data 1590 corresponds to a vessel wall diameter or area, a lumen diameter or area, a plaque burden, or any other value corresponding to an IVUS image taken at any location within a blood vessel.

[0150]

[0167] The longitudinal view 1550 shown in FIG. 15 is an ILD. The ILD 1550 may include any features similar to those described with reference to other ILDs in this application. For example, the ILD 1550 may be an image-based ILD or a measurement-based ILD. The ILD 1550 includes an index 1580. The index 1580 identifies the location along the ILD 1550 where the IVUS image 1530 was acquired. In this manner, the index 1580 corresponds to the index 1524 in the image 1510. In some embodiments, when a user moves the index 1522 within the image 1510, the index 1580 moves to the corresponding location and a new IVUS image is displayed. Similarly, when a user moves the index 1580, the index 1522 moves to the corresponding location and a new IVUS image is displayed.

[0151]

[0168] Additionally, lines 1592 and 1593 are shown superimposed on ILD 1550. Line 1593 corresponds to raw physiological data acquired by the physiological measurement device. Line 1592 corresponds to processed physiological data acquired by the physiological measurement device. Either line 1592 or 1593 may be similar to any of the physiological measurement indicators, lines, or points described herein.

[0152]

[0169] FIG. 16 is a flow diagram of a method 1600 for co-registering endoluminal physiological data with a longitudinal image of a body lumen, according to aspects of the present disclosure. Method 1600 describes automated segmentation of a blood vessel to detect a segment of interest using co-registration of invasive physiology and X-ray images. As shown, method 1600 has several enumerated steps, but embodiments of method 1600 may have additional steps before, after, or between the enumerated steps. In some embodiments, one or more of the enumerated steps are omitted, performed in a different order, or performed simultaneously. The steps of method 1600 may be performed by any suitable component within diagnostic system 100, and all steps need not be performed by the same component. In some embodiments, one or more steps of method 1600 are 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.

[0153]

[0170] In step 1610, method 1600 includes receiving a plurality of endoluminal images acquired by the endoluminal imaging device while the endoluminal imaging device is moved through the patient's body cavity. In some examples, the processor circuit receives a plurality of IVUS images acquired by the IVUS imaging catheter while the IVUS imaging catheter is moved through the patient's blood vessel.

[0154]

[0171] At step 1620, method 1600 includes receiving a plurality of intraluminal physiological measurements obtained by the intraluminal physiological measurement device while the intraluminal physiological measurement device is being moved through the body lumen. In some examples, the processor circuit receives a plurality of intravascular pressure measurements obtained by the pressure sensing guidewire while the pressure sensing guidewire is being moved through the blood vessel.

[0155]

[0172] At step 1630, the method 1600 includes generating a longitudinal view of the body lumen based on the plurality of endoluminal images. In some examples, the processor circuit generates the longitudinal view of the blood vessel based on the plurality of IVUS images.

[0156]

[0173] At step 1640, the method 1600 includes generating a graphical representation based on the plurality of intraluminal physiological measurements. In some examples, the processor circuit generates the graphical representation based on the plurality of intravascular pressure measurements.

[0157]

[0174] In step 1650, method 1600 includes outputting, on a display in communication with the processor circuit, a screen display including the longitudinal view of the body lumen and the graphical representation superimposed on the longitudinal view. In some examples, the processor circuit outputs, on a display in communication with the processor circuit, a screen display including the longitudinal view of the blood vessel and the graphical representation superimposed on the longitudinal view.

[0158]

[0175] Those skilled in the art will recognize that the above-described devices, systems, and methods may be modified in various ways. Accordingly, those skilled in the art will understand that the embodiments encompassed by the present disclosure are not limited to the specific exemplary embodiments described above. In that regard, while exemplary embodiments have been shown and described, the foregoing disclosure contemplates a wide range of modifications, changes, and substitutions. It is understood that such variations may be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be broadly construed in a manner consistent with the present disclosure.

Claims

1. a processor circuit in communication with the endoluminal imaging device; and an endoluminal physiological measurement device, the processor circuit comprising: receiving a plurality of endoluminal images acquired by the endoluminal imaging device while the endoluminal imaging device is moving through a body cavity of a patient; receiving a plurality of endoluminal physiological measurements taken by the endoluminal physiological measurement device while the endoluminal physiological measurement device is moving through the body lumen; generating a longitudinal view of the body cavity based on the plurality of endoluminal images; generating a graphical representation based on the plurality of endoluminal physiological measurements; a display in communication with said processor circuit; the longitudinal view of the body cavity; the graphical representation superimposed on the longitudinal view; A system that outputs a screen display including the

2. The processor circuit further comprises: co-registering the plurality of endoluminal images to a first corresponding location along the body lumen; co-registering the plurality of endoluminal physiological measurements to a second corresponding location along the body lumen; The system of claim 1 , wherein the graphical representation is superimposed on the longitudinal view based on co-registering the plurality of endoluminal images and co-registering the plurality of endoluminal physiological measurements.

3. the graphical representation is superimposed on the longitudinal view such that positions along the graphical representation correspond to positions along the longitudinal view; The system of claim 2 , wherein the location along the graphical representation and the location along the longitudinal view represent the same corresponding location along the body cavity.

4. The processor circuit further comprises: identifying a starting position of the movement of the endoluminal imaging device and a length traveled by the endoluminal imaging device along the body cavity during the movement of the endoluminal imaging device based on co-registering the plurality of endoluminal images; identifying a starting position of the movement of the physiological measuring device and a length traveled by the physiological measuring device along the body cavity during the movement of the physiological measuring device; The graphical representation may include: the starting position of the movement of the endoluminal imaging device; the length that the intraluminal imaging device has advanced along the body cavity; the starting position of the movement of the physiological measurement device; and The length the physiological measuring device has advanced along the body cavity The system of claim 2 , wherein the longitudinal view is superimposed on the longitudinal view based on

5. The processor circuitry further determines an offset between the start position of the movement of the endoluminal imaging device and the start position of the movement of the physiological measurement device, and the graphical representation comprises: the offset, the length traveled by the intraluminal imaging device along the body cavity; and the length the physiological measuring device has advanced along the body cavity The system of claim 4 , wherein the longitudinal view is superimposed on the longitudinal view based on

6. The processor circuit further comprises: identifying a start position of the movement of the endoluminal imaging device and an end position of the movement of the endoluminal imaging device based on co-registering the plurality of endoluminal images; identifying a start position of the movement of the physiological measurement device and an end position of the movement of the intraluminal physiological measurement device; The graphical representation may include: the starting position of the movement of the endoluminal imaging device; the end position of the movement of the endoluminal imaging device; the starting position of the movement of the physiological measurement device; and the end position of the movement of the intraluminal physiological measurement device The system of claim 2 , wherein the longitudinal view is superimposed on the longitudinal view based on

7. The system of claim 1 , wherein the graphical representation comprises a plot based on the plurality of endoluminal physiological measurements.

8. the intraluminal physiological measurement device comprises an intravascular pressure measurement device; the plurality of intraluminal physiological measurements includes a plurality of intravascular pressure measurements; The processor circuit further calculates a plurality of pressure ratios using the plurality of intraluminal physiological measurements; The system of claim 7 , wherein the plot based on the plurality of endoluminal physiological measurements includes a plot of the plurality of pressure ratios.

9. the processor circuit generates a further graphical representation based on the plurality of endoluminal physiological measurements; the screen display includes the further graphical representation superimposed on the longitudinal view; the graphical representation includes an adjusted plot based on the plurality of endoluminal physiological measurements; The system of claim 1 , wherein the further graphical representation comprises a raw plot based on the plurality of endoluminal physiological measurements.

10. the intraluminal physiological measurement device comprises an intravascular pressure measurement device; the plurality of intraluminal physiological measurements includes a plurality of intravascular pressure measurements; The processor circuit further calculates a plurality of pressure ratios using the plurality of intraluminal physiological measurements; The system of claim 1 , wherein the graphical representation includes a plurality of shapes representing variations between the plurality of pressure ratios.

11. the processor circuit receives user input from a user input device in communication with the processor circuit selecting a portion of the longitudinal view; The system of claim 1 , wherein the screen display further includes an indicia superimposed on the longitudinal view that identifies the portion of the longitudinal view.

12. The system of claim 1 , wherein the longitudinal view of the body cavity comprises an image-based longitudinal view that includes the plurality of endoluminal images.

13. the processor circuit calculates a plurality of measurements related to the body cavity using the plurality of endoluminal images; The system of claim 1 , wherein the longitudinal view of the body cavity comprises a measurement-based longitudinal view based on the plurality of measurements.

14. The screen display is an extraluminal image of the body cavity; an indication of a length traveled by the endoluminal imaging device during the movement of the endoluminal imaging device, the indication of the length traveled by the endoluminal imaging device being superimposed on the extraluminal image; and an indication of the length traveled by the endoluminal physiological measurement device during the movement of the endoluminal imaging device, the indication of the length traveled by the endoluminal physiological measurement device being superimposed on the extraluminal image; and The system of claim 1 further comprising:

15. The screen display is an extraluminal image of the body cavity; one intraluminal image among the plurality of intraluminal images; The system of claim 1 further comprising:

16. receiving, by a processor circuit in communication with the endoluminal imaging device, a plurality of endoluminal images acquired by the endoluminal imaging device while the endoluminal imaging device is moving through a body cavity of a patient; receiving, by the processor circuit, a plurality of endoluminal physiological measurements taken by the endoluminal physiological measurement device while the endoluminal physiological measurement device is moved through the body lumen; generating, by the processor circuit, a longitudinal view of the body cavity based on the plurality of endoluminal images; generating, by the processor circuit, a graphical representation based on the plurality of endoluminal physiological measurements; a display in communication with said processor circuit; the longitudinal view of the body cavity; the graphical representation superimposed on the longitudinal view; outputting a screen display including the A method comprising:

17. an intravascular imaging catheter; a pressure-sensing guidewire; a processor circuit in communication with the intravascular imaging catheter and the pressure sensing guidewire; the processor circuitry includes: receiving a plurality of intravascular images acquired by the intravascular imaging catheter while the intravascular imaging catheter is moved through a blood vessel of a patient; receiving a plurality of intravascular pressure measurements taken by the pressure sensing guidewire while the pressure sensing guidewire is moved through the blood vessel; generating a longitudinal view of the blood vessel based on the plurality of intravascular images; generating a graphical representation based on the plurality of intravascular pressure measurements; a display in communication with said processor circuit; the longitudinal view of the blood vessel; the graphical representation superimposed on the longitudinal view; A system that outputs a screen display including the

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