Registration of intraluminal physiological data and longitudinal images of the body cavity 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 to a location along the body lumen indicated in the x-ray image. 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 and benefit to U.S. Provisional Patent Application No. 63 / 288,553, filed on December 11, 2021, and U.S. Provisional Patent Application No. 63 / 292,529, filed on December 22, 2021, each of which is hereby incorporated by reference in its entirety.

[0002]

[0002] The present disclosure generally relates to co - registering data from different medical diagnostic modalities. Specifically, 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 Art

[0003]

[0003] Physicians use a variety of medical diagnostic systems and tools to monitor a patient's health and diagnose medical conditions. The various modalities of medical diagnostic systems provide physicians with various images, models, and / or data regarding a patient's internal structures. These modalities include invasive devices and systems such as intravascular systems, as well as 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 anatomical site, physicians can gain further insights into the patient's condition.

[0004]

[0004] In the field of intravascular imaging and physiological measurement, coregistration of data from invasive devices (e.g., intravascular ultrasound (IVUS) devices or instantaneous fractional flow reserve (iFR) devices) with images acquired non-invasively (e.g., via radiographic angiography) is a powerful technique for improving the efficiency and accuracy of vascular catheter insertion procedures. Coregistration identifies the location of intravascular data measurements along the vessel by mapping the data to angiographic images of the vessel. In this case, the physician can know exactly where in the vessel the measurement was made, rather than having to estimate the location. Coregistration is particularly useful in the diagnosis and treatment of coronary artery disease (CAD). [Overview of the project] [Problems that the invention aims to solve]

[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 intravascular data. Advantageously, this allows the user to more easily understand the anatomical location of the patient and to determine the optimal treatment route. By providing views of pressure data and intravascular imaging data at corresponding locations along a longitudinal representation of the vessel to be treated, physicians can more quickly and accurately determine the appropriate treatment type, such as a stent, and the correct location for treatment along the vessel, such as the proximal and distal landing zones of the stent. [Means for solving the problem]

[0006]

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

[0007]

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

[0008]

[0008] In one embodiment, the processor circuit is further configured to colregist multiple intraluminal images to first corresponding positions along the body cavity and multiple intraluminal physiological measurements to second corresponding positions along the body cavity, and the graphical representation is superimposed on the longitudinal view based on the colregistration of multiple intraluminal images and multiple intraluminal physiological measurements. In one embodiment, the graphical representation is superimposed on the longitudinal view such that positions along the graphical representation correspond to positions along the longitudinal view, and the positions along the graphical representation and positions along the longitudinal view represent the same corresponding positions along the body cavity. In one embodiment, the processor circuit is further configured to identify the starting position of the intraluminal imaging device and the length the intraluminal imaging device travels along the body cavity during its movement, based on colregistration of multiple intraluminal images, and to identify the starting position of the physiological measurement device and the length the physiological measurement device travels along the body cavity during its movement, and the graphical representation is superimposed on the longitudinal view based on the starting position of the intraluminal imaging device, the length the intraluminal imaging device travels along the body cavity, the starting position of the physiological measurement device, and the length the physiological measurement device travels along the body cavity. In one embodiment, the processor circuit is further configured to determine an offset between the starting position of the intraluminal imaging device and the starting position of the physiological measurement device, and the graphical representation is superimposed on the longitudinal view based on the offset, the length the intraluminal imaging device travels along the body cavity, and the length the physiological measurement device travels along the body cavity.In one embodiment, the processor circuit is further configured to identify the starting position and ending position of the intraluminal imaging device, the starting position and ending position of the physiological measurement device, based on the coregistration of multiple intraluminal images, and the graphical representation is superimposed on a longitudinal view based on the starting position and ending position of the intraluminal imaging device, the starting position and ending position of the physiological measurement device. In one embodiment, the graphical representation includes a plot based on multiple intraluminal physiological measurements. In one embodiment, the intraluminal physiological measurement device comprises an intravascular pressure measuring device, the multiple intraluminal physiological measurements include multiple intravascular pressure measurements, the processor circuit is further configured to calculate multiple pressure ratios using the multiple intraluminal physiological measurements, and the plot based on the multiple intraluminal physiological measurements includes a plot of multiple pressure ratios. In one embodiment, the processor circuit is configured to generate a further graphical representation based on a plurality of intraluminal physiological measurements, and the screen display includes a further graphical representation superimposed on the longitudinal view, the graphical representation includes an adjusted plot based on the plurality of intraluminal physiological measurements, and the further graphical representation includes a raw plot based on the plurality of intraluminal physiological measurements. In one embodiment, the intraluminal physiological measurement device comprises an intravascular pressure measurement device, the plurality of intraluminal physiological 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 intraluminal physiological measurements, and the graphical representation includes a plurality of shapes representing the change between the plurality of pressure ratios. In one embodiment, the processor circuit receives user input from a user input device in communication with the processor circuit to select a portion of the longitudinal view, and the screen display further includes an index superimposed on the longitudinal view to identify the portion of the longitudinal view. In one embodiment, the longitudinal view of the body cavity includes an image-based longitudinal view including a plurality of intraluminal images.In one embodiment, the processor circuit is configured to calculate a plurality of measurements related to the body cavity using a plurality of intraluminal images, and the longitudinal view of the body cavity includes a measurement-based longitudinal view based on the plurality of measurements. In one embodiment, the screen display further includes an extraluminal image of the body cavity, an index of the length advanced by the intraluminal imaging device during the movement of the intraluminal imaging device, the index of the length advanced by the intraluminal imaging device is superimposed on the extraluminal image, and an index of the length advanced by the intraluminal physiological measurement device during the movement of the intraluminal imaging device, the index of the length advanced by the intraluminal physiological measurement device is superimposed on the extraluminal image. In one embodiment, the screen display further includes an extraluminal image of the body cavity and one intraluminal image from a plurality of intraluminal images.

[0009]

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

[0010]

[0010] In an exemplary embodiment, a system is provided. The system 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 moving through the patient's blood vessel, receive a plurality of intravascular pressure measurements acquired by the pressure-sensing guidewire while the pressure-sensing guidewire is moving 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 a screen display to a display in communication with the processor circuit, the 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 be described with reference to the accompanying drawings. [Brief explanation of the drawing]

[0013] [Figure 1A]

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

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

[0015] This is a schematic diagram of an intraluminal imaging device according to an aspect of the present disclosure. [Figure 2]

[0016] This is a schematic top view of a planar ultrasonic imaging assembly according to an aspect of the present disclosure. [Figure 3]

[0017] This is a schematic perspective view of an ultrasonic imaging assembly, configured to be wrapped around a support member, according to an aspect of the present disclosure. [Figure 4]

[0018] A schematic cross-sectional side view of an ultrasonic imaging assembly according to an aspect of the present disclosure. [Figure 5]

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

[0020] A schematic diagram of a region of a patient's vasculature according to an aspect of the present disclosure. [Figure 7]

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

[0022] A schematic diagram of the relationship between a fluoroscopic image, an intravascular ultrasound image, and a path defined by the movement of an intravascular device according to an aspect of the present disclosure. [Figure 9]

[0023] A schematic diagram showing the relationship between an intravascular image registered to an extra-luminal image, pressure data registered to an extra-luminal image, and a longitudinal view based on the intravascular image and pressure data according to an aspect of the present disclosure. [Figure 10]

[0024] A schematic diagram of an image-based longitudinal view of a lumen having registered pressure data according to an aspect of the present disclosure. [Figure 11]

[0025] A schematic diagram of an image-based longitudinal view of a lumen having registered pressure data according to an aspect of the present disclosure. [Figure 12]

[0026] A schematic diagram of a measurement-based longitudinal view of a lumen having registered pressure data according to an aspect of the present disclosure. [Figure 13]

[0027] A schematic diagram of an image-based longitudinal view of a lumen having registered pressure data according to an aspect of the present disclosure. [Figure 14]

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

[0029] This is a schematic diagram of a graphical user interface according to the embodiments of this disclosure. [Figure 16]

[0030] This is a flowchart of a method for coregistrating intraluminal physiological data to longitudinal images of a body cavity according to an aspect of this disclosure. [Modes for carrying out the invention]

[0014]

[0031] To facilitate understanding of the principles of this disclosure, embodiments shown in the drawings will now be described using specific language. However, it should be understood that there is no intention to limit the scope of this disclosure. Any changes and further modifications to the devices, systems, and methods described, as well as any further applications of the principles of this disclosure, are well conscientiously included in this disclosure as they would ordinarily occur to a person skilled in the art to which this disclosure relates. In particular, features, components, and / or steps described in relation to one embodiment are well conscientiously intended to be combined with features, components, and / or steps described in relation to other embodiments of this disclosure. However, for the sake of brevity, numerous iterations of these combinations will not be described individually.

[0015]

[0032] Figure 1A is a schematic diagram of an intraluminal imaging system, a physiological measurement system, and an X-ray system according to an aspect of the present disclosure. In some embodiments, the physiological measurement system, the intraluminal imaging system, and the extraluminal imaging system include three separate systems, or a combination of these three systems: a physiological measurement system 101, an intraluminal imaging system 191, and an extraluminal imaging system 151. The physiological measurement system 101 acquires medical data about the patient's body while the intraluminal device is positioned inside the patient's body. For example, the physiological measurement system 101 can control the intraluminal device to acquire intraluminal data about the inside of the patient's body while the intraluminal device is inside the patient's body. The intraluminal imaging system 191 also acquires medical data about the patient's body while the intraluminal device is positioned inside the patient's body. For example, the intraluminal imaging system 101 can control the intraluminal device to acquire intraluminal data about the inside of the patient's body while the intraluminal 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 inside 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 preferred component. Such communication is established via a wired cable, via a wireless signal, or by any other preferred means. In addition, the physiological measurement system 101 is 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 enter into temporary communication via a wired cable, via wireless communication, or by any other preferred 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, measurement criteria calculated using the X-ray imaging system 151, information regarding the date and time of the examination, type and / or severity of the patient's condition or diagnosis, patient's medical history or other patient information, or any preferred data or information. The X-ray imaging system 151 also receives any of this data from the physiological measurement system 101. In some embodiments, as shown in Figure 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 display 132, processor 134, and communication interface 140 shown, and are also in communication with any other components implemented within the control system 130.

[0017]

[0034] The intraluminal imaging system 191 is in communication with the extraluminal imaging system 151 through any preferred component. Such communication is established via a wired cable, via a wireless signal, or by any other preferred means. In addition, the intraluminal imaging system 191 is 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 enter into temporary communication via a wired cable, via wireless communication, or by any other preferred means. In addition, the intraluminal imaging system 191 receives data from the X-ray system 151 such as X-ray images, annotated X-ray images, metrics calculated using the X-ray system 151, information regarding the date and time of the examination, type and / or severity of the patient's condition or diagnosis, patient's medical history or other patient information, or any preferred data or information. The X-ray system 151 also receives any of this data from the intraluminal imaging system 191. In some embodiments, as shown in Figure 1, the intraluminal 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 display 132, processor 134, and communication interface 140 shown, and are also in communication with any other components implemented within the control system 130.

[0018]

[0035] The intraluminal imaging system 191 is in communication with the physiological measurement system 101 through any preferred component. Such communication is established via a wired cable, a wireless signal, or any other preferred means. In addition, the intraluminal imaging system 191 is 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 enter into temporary communication via a wired cable, wireless communication, or any other preferred means. In addition, the intraluminal imaging system 191 receives data from the physiological measurement system 101 such as pressure data, blood flow data, measurement criteria calculated using the physiological measurement system 101, information regarding the date and time of the examination, type and / or severity of the patient's condition or diagnosis, patient's medical history or other patient information, or any preferred data or information. The physiological measurement system 101 also receives any of this data from the intraluminal imaging system 191. In some embodiments, as shown in Figure 1, the intraluminal 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 display 132, processor 134, and communication interface 140 shown, and are also in communication with any other components implemented within the control system 130.

[0019]

[0036] In some embodiments, system 100 does not include a control system 130 that is in communication with the physiological measurement system 101, the intraluminal imaging system 191, and / or the X-ray imaging system 151. Instead, system 100 includes separate control systems. For example, one control system is in communication with or part of the physiological measurement system 101, another control system is in communication with or part of the intraluminal imaging system 191, and an additional separate control system is in communication with or part of the X-ray imaging system 151. In this embodiment, the separate control systems of the physiological measurement system 101, the intraluminal imaging system 191, and the 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 of the physiological measurement system 101, the control system of the intraluminal imaging system 191, or the control system of the extraluminal imaging system 151 performs any or all of the coregistration steps described herein. In some embodiments, one control system 130 is configured to communicate with and control both the intraluminal 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 configured to communicate with and control both the intraluminal 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 configured to communicate with and control both the physiological measurement system 101 and the extraluminal imaging system 151, while a separate control system 130 controls the intraluminal 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 flow reserve ratio (iFR) system, a partial flow reserve (FFR) system, or a Pd / Pa system. The intraluminal system 101 includes a pressure guide wire, such as a solid core pressure wire. The pressure wire includes one or more features described in U.S. Patent No. 5,715,827, granted February 10, 1998, entitled "Ultra Miniature Pressure Sensor and Guide Wire Using the Same and Method," U.S. Patent No. 8,277,386, granted October 2, 2012, entitled "Combination Sensor Guidewire and Methods of Use," and U.S. Patent No. 9,339,348, granted May 17, 2016, all of which are incorporated herein by reference in their entirety.

[0021]

[0038] Broadly speaking, the pressure sensing device is placed within the 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 the pressure pullback procedure, the pressure sensing catheter 103 is positioned in the blood vessel at a proximal position to the measurement area. The sensor of the pressure sensing guidewire 102 is positioned in the blood vessel at a distal position to the measurement area. The pressure sensing catheter 103 remains substantially stationary during the pullback procedure. The pressure guidewire 102 is then pulled so that the sensor moves from the distal position to the proximal position through the blood vessel. As the distal guidewire sensor moves through the lumen, both the sensor on the guidewire 102 and the sensor on the catheter 103 collect pressure measurements. Thus, for each position of the guidewire 102, two pressure measurements are collected: the distal guidewire pressure and the proximal catheter pressure. These two pressures are then compared to generate a pressure ratio. The pressure ratio is the partial flow reserve (FFR), instantaneous flow reserve ratio (iFR), Pd / Pa, and / or any other preferred pressure ratio. For example, when two sensors are in substantially the same location within the vessel (e.g., after the pressure pullback procedure is completed), the pressures recorded by each sensor will be the same or substantially the same. Therefore, the pressure ratio of these two resulting pressures will be 1.0 or close to 1.0. If the pullback starting position is distal to the occlusion within the 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 of less than 1.0. How much lower the pressure ratio is than 1.0 indicates the severity of the occlusion. As the distal guidewire sensor moves proximal along the guidewire within the vessel from its starting position (distal within the 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 at various locations along the vessel being analyzed, such that the pressure ratio corresponding to the position of the distal guidewire pressure sensor approaches 1.0 as the distal guidewire pressure sensor approaches the proximal catheter sensor.

[0022]

[0039] The communication interface 140 facilitates the communication of measurement values ​​between the control system 130 and the physiological measurement system 101. In some embodiments, the communication interface 140 performs preliminary processing of the data before relaying it to the processor 134. In one embodiment, the communication interface 140 also supplies high-voltage and low-voltage DC power to support the operation of the devices of 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 a transmission line bundle to the communication interface 140 and physically couples any pressure sensing device, including a pressure sensor guidewire 106 and / or a pressure sensing catheter 103, to the communication interface 140. In some embodiments, the communication interface 140 is the 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 to facilitate 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 a pressure-sensing guidewire 102, or with any other system or device. For example, the hemodynamic system 105 is in communication with an extraluminal imaging system, such as an extraluminal imaging system 151. The hemodynamic system 105 is in communication with electrocardiogram (ECG) electrodes and can provide a graphical display of the patient's cardiac electrocardiogram. The hemodynamic system 105 is in communication with a heart rate sensor and can provide a graphical display of heart rate. The hemodynamic system 105 is in communication with an external blood pressure monitor (e.g., a blood pressure monitor, an inflatable cuff, and / or pressure gauge) and can provide a graphical display of 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 pressure ratios based on pressure data such as partial flow reserve (FFR), instantaneous flow reserve ratio (iFR), and / or other preferred ratios 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 flow-related values ​​based on pressure data such as coronary flow reserve (CFR), flow velocity, and flow rate.

[0026]

[0043] Figure 1B is a schematic diagram of an extraluminal imaging system according to an aspect of the present disclosure. The X-ray imaging system 151 includes an X-ray imaging apparatus or device 152 configured to perform imaging techniques, among others, X-ray imaging, angiography, fluoroscopy, radiography, and venography. Based on the X-ray image data collected by the X-ray device 152, the X-ray imaging system 151 can generate a single X-ray image (e.g., an angiographic or venographic image) or multiple (e.g., two or more) X-ray images (e.g., video and / or fluoroscopic image streams). The X-ray imaging device 152 is any preferred type of device, such as a stationary X-ray system including a fixed C-arm X-ray device, a movable C-arm X-ray device, a straight-arm X-ray device, or a U-arm device. The X-ray imaging device 152 is further any preferred movable device. The X-ray imaging device 152 is also in communication with the control system 130. In some embodiments, the X-ray system 151 includes a digital radiography device or any other preferred device.

[0027]

[0044] The X-ray device 152 shown in Figure 1 includes an X-ray source 160 and an X-ray detector 170 including an input screen 174. The X-ray source 160 and the detector 170 are mounted at a distance from each other. An anatomical site of the patient or subject 180 is placed between the X-ray source 160 and the X-ray detector 170. For example, an anatomical site of a patient (including blood vessels 120) may be placed 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. Several embodiments of the X-ray source 160 include one or more vacuum tubes, each containing 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 is of any preferred type or is constructed from any preferred material, including tungsten or rhenium-tungsten, and is positioned within a concave region of the cathode. One of the functions 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 is also constructed from any preferred material and is configured to create X-ray radiation from electrons emitted from the cathode. In addition, the anode dissipates the heat generated in the process of producing X-ray radiation. The anode is formed 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 a hermetically sealed enclosure, sometimes called an envelope.

[0029]

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

[0030]

[0047] The detector 170 is configured to acquire an X-ray image and includes an input screen 174. The input screen 174 includes one or more sensitizing screens configured to absorb X-ray energy and convert that energy into light. The light then exposes the film. The input screen 174 is used to convert X-ray energy into light in embodiments where the film is more sensitive to light than to X-ray radiation. Different types of sensitizing screens within the image enhancement tube are selected depending on the area of ​​the patient being imaged, the detail of the image and / or the requirements for patient exposure, or any other factor. The sensitizing screens are constructed from any suitable material, including lead barium sulfate, strontium barium sulfate, barium chloride fluoride, yttrium sulfide, 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 the 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 is either an indirect conversion FPD or a direct conversion FPD. The detector 170 also includes a charge-coupled device (CCD). The X-ray detector 370 is also called an X-ray sensor.

[0031]

[0048] Subject 180 is any preferred object to be imaged. In exemplary embodiments, the object is an anatomical region of the patient. More specifically, the anatomical region to be imaged includes the patient's chest, abdomen, pelvic region, neck, legs, head, feet, region containing the cardiovascular system, or region containing the peripheral vascular system, and includes a variety of anatomical structures, including 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 non-contrast X-ray images. In some embodiments, the X-ray imaging system 151 is configured to acquire contrast-enhanced X-ray images (e.g., angiography or venography). In such embodiments, a contrast agent or X-ray dye is introduced into the anatomical site of the patient before imaging. The contrast agent is also called a radiographic contrast agent, contrast substance, contrast dye, or contrast medium. The contrast dye is a contrast dye of any suitable material, chemical, or compound, and is in the form of a liquid, powder, paste, tablet, or any other suitable form. For example, the contrast dye is 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 anatomical site of the patient. The contrast agent absorbs external X-rays, reducing their 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 computed tomography (CT) or magnetic resonance imaging (MRI).

[0034]

[0051] When the control system 130 is in communication with the X-ray system 151, the communication interface 140 facilitates the communication of signals between the control system 130 and the X-ray device 152. This communication includes providing control commands to the X-ray source 160 and / or X-ray detector 170 of the X-ray device 152, and receiving data from the X-ray device 152. In some embodiments, the communication interface 140 performs preliminary processing of the X-ray data before relaying the data to the processor 134. In examples of such embodiments, the communication interface 140 performs amplification, filtering, and / or aggregation of the data. In one embodiment, the communication interface 140 also supplies high-voltage and low-voltage DC power supplies to support the operation of the device 152, including the circuitry within the device.

[0035]

[0052] The processor 134 receives X-ray data from the X-ray device 152 via the communication interface 140, processes the data, and reconstructs an image of the anatomical site being imaged. The processor 134 outputs image data so that the image is displayed on the display 132. In embodiments in which a contrast agent is introduced into an anatomical site of a patient to generate a venogram, the specific region of interest being imaged is one or more blood vessels, or other divisions or parts of the human vascular system. The contrast agent identifies both fluid-filled natural and / or artificial structures, such as arteries or veins of the patient's vascular system, including cardiovascular, peripheral, neurovascular, renal, and / or any other suitable lumens inside the body. For example, the X-ray device 152 is used to examine any number of anatomical locations and histological types, including, but not limited to, all of the aforementioned organs, fluids, or other structures or parts of the anatomical site. In addition to natural structures, the X-ray device 152 is used to examine artificial structures, such as any of the aforementioned structures.

[0036]

[0053] The processor 134 is configured to receive X-ray images stored by the X-ray imaging device 152 during clinical procedures. The images are further enhanced by other information such as the patient's medical history, patient records, IVUS imaging, preoperative ultrasound imaging, preoperative CT, or any other preferred data.

[0037]

[0054] Figure 1C is a schematic diagram of an intraluminal imaging device 102 according to an aspect of the present disclosure. Figure 1C also shows an aspect of an intraluminal imaging system 191 including the intraluminal imaging device 102 and associated components. As described above, the intraluminal imaging system 191 is incorporated into various systems of the broader system 100. In addition, the intraluminal imaging system 191 includes additional components other than those illustrated in Figure 1C. In some embodiments, the intraluminal imaging device 102 is a catheter or a guidewire.

[0038]

[0055] The intraluminal imaging system 191 may be an ultrasound imaging system. In some cases, the intraluminal imaging system 191 may be an intravascular ultrasound (IVUS) imaging system. The intraluminal imaging system 191 includes an intraluminal imaging device 102, such as a catheter, guidewire, or guidecatheter, which is in communication with the control system 130. The control system 130 includes, among other components, a display 132, a processor 134, and a communication interface 140. The intraluminal 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] Broadly speaking, the IVUS device 102 emits ultrasonic energy from a transducer array 124 included in a scanner assembly, also called an IVUS imaging assembly, which is mounted near the distal end of the catheter device. The ultrasonic energy is reflected by tissue structures in the surrounding medium, such as blood vessels 120, or by another body cavity surrounding the scanner assembly 110, and the ultrasonic echo signal is received by the transducer array 124. In this regard, the device 102 may be sized, molded, or configured to be placed within the patient's body cavity. A communication interface 140 transfers the received echo signal to a processor 134 of the control system 130, where the ultrasonic image (including fluid information in some embodiments) is reconstructed and displayed on the display 132. The control system 130, including the processor 134, may be operable to facilitate the functions of the IVUS imaging system 191 described herein. For example, the processor 134 may execute computer-readable instructions stored in a non-temporary tangible computer-readable medium.

[0040]

[0057] The communication 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 a transmit trigger signal to the integrated circuit controller chip included in the scanner assembly 110 to activate a transmit circuit and generate an electrical pulse to excite the selected transducer array elements; and / or (3) receiving an echo signal received from the selected transducer array elements, amplified via an amplifier included on the integrated circuit controller chip of the scanner assembly 110. In some embodiments, the communication interface 140 performs preliminary processing of the echo data before relaying the data to the processor 134. In examples of such embodiments, the communication interface 140 performs amplification, filtering, and / or aggregation of the data. In one embodiment, the communication interface 140 also supplies high-voltage and low-voltage DC power to support the operation of the device 102, which includes the circuitry within the scanner assembly 110.

[0041]

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

[0042]

[0059] In some embodiments, the IVUS device includes conventional solid-state IVUS catheters such as the EagleEye® catheter, Visions PV.014P RX catheter, Visions PV.018 catheter, Visions PV.035, and Pioneer Plus catheter, each available from Koninklijke Philips NV, as well as several features similar to those disclosed in U.S. Patent No. 7,846,191, which is incorporated herein by reference in its entirety. For example, the IVUS device 102 includes a scanner assembly 110 near the distal end of the device 102 and a transmission line bundle 112 extending along the longitudinal body of the device 102. The transmission line bundle or cable 112 may 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 may include a four-conductor transmission line configuration using, for example, 41AWG gauge wire. In one embodiment, the cable 112 may include a seven-conductor transmission line configuration using, for example, 44AWG gauge wire. In some embodiments, 43AWG gauge wire can be used.

[0043]

[0060] The transmission line bundle 112 terminates at a patient interface module (PIM) connector 114 located 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 the 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 distally to guide the device 102 into a blood vessel 120.

[0044]

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

[0045]

[0062] Figure 2 is a schematic top view of a planar ultrasonic imaging assembly according to an aspect 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 dies 206A and 206B) formed in a control region 208, with a transition region 210 positioned between them. The transducer array 124 includes an array of ultrasonic 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 planar configuration in Figure 2. Six control logic dies 206 are shown in Figure 2, but any number of control logic dies 206 can be used. For example, one, two, three, four, five, six, seven, eight, nine, ten, or more control logic dies 206 can be used.

[0046]

[0063] The flexible substrate 214 on which the transducer control logic die 206 and transducer element 212 are mounted provides structural support and interconnection for electrical coupling. The flexible substrate 214 is constructed to include a film layer of 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 DuPont). In the flat configuration shown in Figure 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 (Figure 3). Thus, the thickness of the film layer of the flexible substrate 214 generally relates to the degree of curvature of the finally assembled flexible assembly 110. In some embodiments, the film layer is between 5 μm and 100 μm, and in some specific embodiments, it is between 5 μm and 25.1 μm, for example, 6 μm.

[0047]

[0064] A pair of transducer-controlled logic dies 206 is a non-limiting example of a control circuit. The transducer region 204 is located at the distal portion 221 of the flexible substrate 214. The control region 208 is located at the proximal portion 222 of the flexible substrate 214. The transition region 210 is located between the control region 208 and the transducer region 204. The dimensions of the transducer region 204, the control region 208, and the transition region 210 (e.g., lengths 225, 227, 229) may differ in different embodiments. In some embodiments, lengths 225, 227, and 229 may be substantially similar, or the length 227 of the transition region 210 may be shorter than lengths 225 and 229, respectively, while 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.

[0048]

[0065] The control logic dies 206 are not necessarily homogeneous. In some embodiments, a single controller is designated as the master control logic die 206A and includes a communication interface for cable 112 between the processing system, e.g., processing system 106, and the flexible assembly 110. Thus, the master control circuit includes control logic that decodes control signals received via cable 112, transmits control responses via cable 112, amplifies echo signals, and / or transmits echo signals via cable 112. The remaining controllers are slave controllers 206B. The slave controllers 206B include control logic that drives a plurality of transducer elements 512 arranged on a transducer element 212 to emit ultrasonic signals and selects the transducer element 212 that receives the echo. In the embodiments described, the master controller 206A does not directly control the transducer elements 212. In other embodiments, the master controller 206A drives the same number of transducer elements 212 as the slave controllers 206B, or drives fewer sets of transducer elements 212 compared to the slave controllers 206B. In an exemplary embodiment, a single master controller 206A and eight slave controllers 206B are provided, with eight transducers assigned to each slave controller 206B.

[0049]

[0066] In one embodiment, to electrically interconnect the control logic die 206 and the transducer element 212, the flexible substrate 214 includes a conductive trace 216 formed on a film layer that carries signals between the control logic die 206 and the transducer element 212. Specifically, the conductive trace 216 providing communication between the control logic die 206 and the transducer element 212 extends along the flexible substrate 214 within a transition region 210. In some cases, the conductive trace 216 can also facilitate electrical communication between a master controller 206A and a slave controller 206B. The conductive trace 216 can also provide a pair of conductive pads that contact the conductor 218 of the cable 112 when the conductor 218 of the cable 112 is mechanically and electrically coupled to the flexible substrate 214. Suitable materials for the conductive trace 216 include copper, gold, aluminum, silver, tantalum, nickel, and tin, which are deposited on the flexible substrate 214 by processes such as sputtering, plating, and etching. In one embodiment, the flexible substrate 214 includes a chromium adhesive layer. The width and thickness of the conductive traces 216 are selected to provide appropriate conductivity and elasticity when the flexible substrate 214 is wound. In this regard, an exemplary range of thickness for the conductive traces 216 and / or conductive pads is 1 to 5 μm. For example, in one embodiment, 5 μm conductive traces 216 are separated at 5 μm intervals. Furthermore, the width of the conductive traces 216 on the flexible substrate is determined by the width of the conductor 218 to which the trace or pad is coupled.

[0050]

[0067] In some embodiments, the flexible substrate 214 includes a conductor interface 220. The conductor interface 220 is located on the flexible substrate 214 where the conductors 218 of the cable 112 are coupled to the flexible substrate 214. For example, at the conductor interface 220, the bare conductors of the cable 112 are electrically coupled to the flexible substrate 214. The conductor interface 220 may be a tab extending from the body of the flexible substrate 214. In this respect, the body of the flexible substrate 214 can collectively refer to the transducer region 204, the controller region 208, and the transition region 210. In the illustrated embodiment, the conductor interface 220 extends from the proximal portion 222 of the flexible substrate 214. In other embodiments, the conductor interface 220 may be located on other parts 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 the tab or conductor interface 220, for example, the width 224, can be smaller than the dimensions of the body of the flexible substrate 214, for example, the width 226. In some embodiments, the substrate forming the conductor interface 220 is made of the same material as the flexible substrate 214 and / or is as flexible as the flexible substrate 214. In other embodiments, the conductor interface 220 is made of a different material than the flexible substrate 214 and / or is relatively more rigid than the flexible substrate 214. For example, the conductor interface 220 may be made of plastics, thermoplastics, polymers, rigid polymers, etc., including polyoxymethylene (e.g., DELRIN®), polyetheretherketone (PEEK), nylon, liquid crystal polymer (LCP), and / or other suitable materials.

[0051]

[0068] Figure 3 is a schematic perspective view of an ultrasonic imaging assembly with a winding configuration around a support member according to an aspect of this disclosure. Figure 3 shows a perspective view of a scanner assembly 110 with a winding configuration. In some cases, the flexible substrate 214 transitions from a flat configuration (Figure 2) to a winding or more cylindrical configuration (Figure 3). For example, in some embodiments, techniques disclosed in one or more of U.S. Patent No. 6,776,763, entitled "ULTRASONIC TRANSDUCER ARRAY AND METHOD OF MANUFACTURING THE SAME" and U.S. Patent No. 7,226,417, entitled "HIGH RESOLUTION INTRAVASCULAR ULTRASOUND SENSING ASSEMBLY HAVING A FLEXIBLE SUBSTRATE" are utilized, and these patents are each incorporated herein by reference in their entirety.

[0052]

[0069] Depending on the application examples and embodiments of the inventions of this disclosure, the transducer element 212 is a piezoelectric transducer, a single-crystal transducer, or a PZT (lead zirconate titanate) transducer. In other embodiments, the transducer elements of the transducer array 124 are bendable transducers, piezoelectric micromachine ultrasonic transducers (PMUTs), capacitive micromachine ultrasonic transducers (CMUTs), or any other suitable type of transducer element. In such embodiments, the transducer element 212 includes an elongated semiconductor material or other suitable material that enables micromachining or similar methods to arrange extremely small elements or circuits on a substrate.

[0053]

[0070] In some embodiments, the transducer element 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 is also referred to as the longitudinal axis of the scanner assembly 110, the flexible elongated member 121, or the device 102. For example, the cross-sectional contour of the imaging assembly 110 in the transducer element 212 and / or controller 206 may be circular or polygonal. Any suitable annular polygonal shape can be implemented, based on the number of controllers or transducers, the flexibility of the controllers or transducers, etc. Some examples include pentagons, hexagons, heptagons, octagons, nonagons, decagons, etc. In some examples, the transducer controller 206 is used to control the ultrasonic transducer 512 of the transducer element 212 to acquire imaging data related to the blood vessel 120.

[0054]

[0071] The support member 230 may, in some cases, be called a unibody. The support member 230 may be made 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, “Pre-Doped Solid Substrate for Intravascular Devices,” filed April 28, 2014, which is incorporated herein by reference in whole. In some embodiments, the support member 230 is made of 303 stainless steel. The support member 230 may be a ferrule having a distal flange or distal portion 232 and a proximal flange or proximal portion 234. The support member 230 is tubular in shape and may define a lumen 236 extending in its longitudinal direction. The lumen 236 may be sized and molded to accommodate the guidewire 118. The support member 230 may be manufactured using any preferred process. For example, the support member 230 may be machined and / or electrochemically or laser-machined by removing material from a blank and forming the support member 230, or it may be formed by an injection molding process or a micro-injection molding process.

[0055]

[0072] Figure 4 is a schematic cross-sectional side view of an ultrasonic imaging assembly according to an aspect of the present disclosure. The intraluminal imaging device 102 includes a flexible substrate 214 and a support member 230 according to an aspect of the present disclosure. The lumen 236 is connected to an inlet / outlet port 116 and is sized and molded to accommodate a guidewire 118 (Figure 1). In some embodiments, the support member 230 is formed as a single unit, and in other embodiments, the support member 230 is formed from different components such as ferrules and stands 242, 243, and 244 that are fixedly bonded to each other. In some cases, the support member 230 and / or one or more of its components are fully integrated with an inner member 256. In some cases, the inner member 256 and the support member 230 are joined as one, for example, in the case of a polymer support member.

[0056]

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

[0057]

[0074] To improve acoustic performance, an acoustic backing material 246 is filled into the cavity between the transducer array 212 and the surface of the support member 230. The liquid backing material 246 may be introduced between the flexible substrate 214 and the support member 230 via a passage 235 in the stand 242 or through additional recesses described in more detail below. The backing material 246 serves to attenuate undesirable inwardly propagating ultrasonic energy emitted by the transducer array 212.

[0058]

[0075] The cavity between the circuit controller chip 206 and the surface of the support member 230 is filled with 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 can be any preferred material.

[0059]

[0076] In some embodiments, the central body 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 (during the assembly process, before the inner member 256 extends through the lumen of the unibody). In some embodiments, a suction force is applied through one of the passages 235 of the stands 242, 244 or to any other preferred recess, and liquid backing material 246 is supplied between the flexible substrate 214 and the support member 230 through the other passage 235 of the stands 242, 244 or any other preferred recess. The backing material may be cured so that it can solidify and harden. In various embodiments, the support member 230 may include more than three stands 242, 243, and 244, or only one or two of the stands 242, 243, and 244, or may not include any 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, which are sized and molded to lift and support the distal and / or proximal portions of the flexible substrate 214.

[0060]

[0077] In some embodiments, the support member 230 may be substantially cylindrical. Other shapes of the support member 230 are also contemplated, including geometric, non-geometric, symmetrical, and asymmetrical cross-sectional profiles. When used herein, the term "shape of the support member 230" refers to the cross-sectional profile of the support member 230. In other embodiments, different portions of the support member 230 may have various shapes. For example, the proximal portion 264 may have an outer diameter 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) may increase or decrease in response to a change in the outer diameter. 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 include 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 positioned 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 wound configuration. In some embodiments, a gap exists between the flexible substrate 214 and the tip member 252. The distal member 252 may be the most distal component of the intraluminal imaging device 102. The distal tip member 252 is a flexible polymer component that defines the most distal end of the imaging device 102. The distal tip member 252 further defines a lumen that communicates with the lumen 236 defined by the support member 230. The guidewire 118 extends through the lumen 236 and the lumen defined by the tip member 252.

[0062]

[0079] One or more adhesives may be placed between various components in the distal portion of the intraluminal imaging device 102. For example, one or more of the flexible substrate 214, support member 230, distal member 252, proximal inner member 256, transducer array 212, and / or proximal outer member 254 may be bonded to each other via adhesive. In other words, the adhesive may come into contact with the components, in particular, for example, the transducer array 212, flexible substrate 214, support member 230, distal member 252, proximal inner member 256, and / or proximal outer member 254.

[0063]

[0080] Figure 5 is a schematic diagram of a processor circuit according to an aspect of the present disclosure. The processor circuit 510 is mounted in the control system 130, intraluminal imaging system 191, physiological measurement system 101, and / or X-ray imaging system 151, or any other preferred location. In one example, the processor circuit 510 is in communication with the intraluminal imaging device 102, the X-ray imaging device 152, the pressure-sensing guidewire and / or catheter described above, and / or the display 132 in system 100. The processor circuit 510 includes a processor 134 and / or a communication interface 140 (Figure 1A). 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] The processor 560 includes a CPU, GPU, DSP, application-specific integrated circuit (ASIC), controller, FPGA, other hardware device, firmware device, or any combination thereof, configured to perform the operations described herein. The 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 working in conjunction with a DSP core, or any other such configuration.

[0065]

[0082] Memory 564 includes cache memory (e.g., the cache memory of 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 combinations of different types of memory. In one embodiment, memory 564 includes a non-temporary computer-readable medium. Memory 564 stores instructions 566. Instructions 566, when executed by processor 560, include instructions that cause processor 560 to perform operations described herein with reference to probe 110 and / or host 130 (Figure 1). Instructions 566 are also called code. The terms “instruction” and “code” should be broadly interpreted to include any type of computer-readable statement. For example, the terms “instruction” and “code” refer to one or more programs, routines, subroutines, functions, procedures, etc. “Instructions” and “code” can include a single computer-readable statement or many computer-readable statements.

[0066]

[0083] The communication module 568 may include any electronic and / or logic circuits to facilitate direct or indirect communication of data between the processor circuit 510, the probe 110, and / or the display 132. In this respect, the communication module 568 may be an input / output (I / O) device. In some cases, the communication module 568 facilitates direct or indirect communication between various elements of the processor circuit 510, the probe 110 (Figure 1C), and / or the host 130 (Figure 1A).

[0067]

[0084] Figure 6 is a schematic diagram of a region 600 of the patient's vascular system according to an aspect of this disclosure. Figure 6 shows a diagram of blood vessels 690 measured using a physiological measurement system 101 and an intraluminal imaging system 191. The physiological measurement procedure is completed before or after the intraluminal imaging procedure.

[0068]

[0085] In one example, a physiological measurement procedure is performed. During this procedure, the pressure-sensing device of the physiological measurement system 101 is positioned within the blood vessel 690. For example, a pressure-sensing catheter is positioned at position 611 within the blood vessel 690. The distal pressure sensor of the pressure-sensing guidewire is positioned at the starting position 610, as indicated by point 602. During the pressure-sensing procedure, the distal pressure sensor of the pressure-sensing guidewire moves from position 610 to position 611 within the blood vessel 690. As the guidewire is pulled from position 610 to position 611, the distal sensor acquires a pressure measurement. The proximal pressure sensor of the stationary catheter positioned at position 611 also collects a pressure measurement. As illustrated with reference to Figure 7, for each position along the blood vessel 690 that 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] In Figure 6, pathway 603 is shown adjacent to vessel 690. Pathway 603 illustrates the shape and length of the guidewire's distal pressure sensor's path due to pullback, in addition to the guidewire's distal pressure sensor traveling within vessel 690 rather than adjacent to the lumen. This pathway 603 is located within vessel 690 or at any other location.

[0070]

[0087] The intraluminal imaging procedure is performed using an intravascular ultrasound (IVUS) imaging system, for example, an IVUS imaging device or catheter, such as device 102 (Figure 1C). During this procedure, the IVUS imaging device 102 of the intraluminal imaging system 191 is positioned within the blood vessel 690. For example, device 102 is positioned at position 612 within the blood vessel 690. This position is the starting position of device 102, as indicated by point 604. During the intraluminal imaging procedure, device 102 moves from position 612 to position 613 within the blood vessel 690. As the intraluminal imaging device 102 is pulled from position 612 to position 613, device 102 acquires intravascular ultrasound data. Intraluminal ultrasound data acquired at specific positions along the path 605 through which the intraluminal imaging device 102 has advanced is received by the control system 130 and used to create radial cross-sectional images (e.g., IVUS images) of the blood vessel 690 at those positions. As explained with reference to Figure 8, an IVUS image is generated for each location along the blood vessel 690 through which the device 102 has passed, and is associated with that location along the blood vessel 690.

[0071]

[0088] In Figure 6, the pathway 605 is shown adjacent to the blood vessel 690. The pathway 605 illustrates the shape and length of the pathway of the intraluminal imaging device 102 of the pullback intraluminal imaging system 191, in addition to the fact that the device 102 travels within the blood vessel 690 rather than adjacent to the lumen. This pathway 605 is located within the blood vessel 690 or at any other location.

[0072]

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

[0073]

[0090] In some embodiments, the starting position of the pressure sensor on the guidewire and the starting position of the intraluminal imaging device 102 are the same. Similarly, the ending position of the pressure guidewire is the same as the ending position of the device 102. As a result, all regions of the blood vessel 690 imaged by the imaging device 102 are also measured by the pressure-sensing guidewire.

[0074]

[0091] Referring to Figures 7 and 8, embodiments for co-registrating pressure data and intravascular images to extraluminal images (e.g., angiographic images) are disclosed. In some embodiments, the system uses physiological co-registration to angiography as a first step to establish the length of the physiological pullback. The system then co-registrates the IVUS pullback to the same angiography to establish its length. The system then uses the lengths of these pullbacks and their starting positions to co-registrate the physiological data to a calibrated longitudinal section of the IVUS pullback. In some embodiments, the registration of physiological data, intravascular data, and angiographic images is referred to as triregistration. In some embodiments, triregistration refers to the correlation of three distinct imaging modalities. Each of these modalities is displayed simultaneously.

[0075]

[0092] Figure 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 aspect of the present disclosure. Figure 7 illustrates a method for corregistrating 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 an anatomical site in the patient.

[0076]

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

[0077]

[0094] While the physician performs a pullback with a pressure-sensing device, for example, while a pressure-sensing guidewire moves through the blood vessels of the anatomical site, the X-ray device images the patient's anatomical site. The pressure-sensing guidewire is substantially similar to the pressure-sensing guidewire described with reference to Figure 1A. The X-ray device used to acquire the fluoroscopic image 710 is substantially similar to the X-ray device 152 in Figure 1B. In some embodiments, the fluoroscopic image 710 is acquired in the absence of contrast agent in the patient's vascular system. Such embodiments are shown by the fluoroscopic image 710 in Figure 7. In other embodiments, contrast agent is present in the patient's vascular system. In this respect, the fluoroscopic image 810 is alternatively an angiographic image or any preferred type of extraluminal image. Within the fluoroscopic image 710, the radiopaque portion of the intravascular device 720 is visible. The fluoroscopic image 710 corresponds to a continuous 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 the fluoroscopic image 710 is acquired using an X-ray source 160 and an X-ray detector 170 positioned at any suitable angle relative to the patient's anatomical region. This angle is indicated by angle 790.

[0078]

[0095] The intravascular device 720 is 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 vascular system, the radiographic imaging system acquires multiple fluoroscopic images 710 showing the radiopaque portion of the pressure-sensing guidewire. Thus, each fluoroscopic image 710 shown in Figure 7 depicts the pressure-sensing guidewire positioned at various locations so that the processor circuit 510 (Figure 5) can track the position of the pressure-sensing guidewire throughout the intravascular colregistration procedure.

[0079]

[0096] As the pressure-sensing guidewire is pulled through the patient's vascular system, 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 preferred data, including FFR data, iFR data, blood pressure, any other measurement or criterion related to blood flow, or other physiological data acquired during the guidewire pullback.

[0080]

[0097] As the physician withdraws the pressure-sensing guidewire through the patient's vascular system, each iFR data point 730 acquired by the pressure-sensing guidewire is associated with a location in the fluoroscopic image 710, as indicated by the arrow 761. For example, the first pressure data measurement 730 shown in Figure 7 is associated with a location in the first fluoroscopic image 710. The first iFR measurement 730 is the pressure ratio acquired by the pressure-sensing guidewire (working in conjunction with the proximal pressure-sensing catheter) at a location in the vascular system, as depicted in the first fluoroscopic image 710 and as indicated by the radiopaque portion of the pressure-sensing guidewire in the image 710. Similarly, further iFR measurements 730 are associated with further fluoroscopic images 710 showing the pressure-sensing guidewire at a new location in the image 710, and so on. The processor circuit identifies the location of the pressure-sensing guidewire in each acquired X-ray image 710. The processor circuit 510 identifies the location of the pressure-sensing guidewire by any preferred method. For example, the processor circuit 510 performs a variety of image processing techniques, such as edge recognition of radiopaque markers, pixel-level analysis to identify transitions between bright and dark pixels, filtering, or any other preferred technique to locate pressure-sensing guidewires. In some embodiments, the processor circuit identifies the location of pressure-sensing guidewires in the X-ray image 710 using a variety of artificial intelligence methods, including deep learning techniques such as neural networks or any other preferred technique.

[0081]

[0098] During the device pullback, any preferred number of iFR data points 730 and any preferred number of fluoroscopic images 710 are acquired. In some embodiments, there are fluoroscopic images 710 and iFR data 730 in a 1:1 ratio. In other embodiments, there are different numbers of fluoroscopic images 710 and iFR data 730. The process of co-registrating the iFR data 730 and / or intravascular data 830 (described with reference to Figure 8) with one or more radiographic images includes several features similar to those described in U.S. Patent No. 7,930,014, filed January 11, 2006, entitled “VASCULAR IMAGE CO-REGISTRATION,” which is incorporated herein by reference in its entirety. The coregistration process also includes several features similar to those described in U.S. Patents 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 entirety.

[0082]

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

[0083]

[0100] As indicated by arrow 762, the two-dimensional path 740 is generated based on the perspective image 710, so each location along the two-dimensional path 740 is associated with one or more perspective images 710. For example, at location 741 along the path 740, the first perspective image 710 depicts a pressure-sensing guidewire at that same location 741. In addition, as indicated by arrow 761, a correspondence is established between the perspective image 710 and the iFR data 730, so the iFR data 730, such as the first iFR measurement shown, is also associated with 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 preferred fluoroscopic image 711 (e.g., one of the fluoroscopic images 710 in the fluoroscopic image stream). In this way, any position along the path 740 displayed on the fluoroscopic image 711 is associated with iFR data such as the iFR measurement 730, as indicated by arrow 764. For example, the first pressure data 730 shown in Figure 7 is acquired simultaneously with the first fluoroscopic image 710 shown, and these two images are associated with each other as indicated by arrow 761. In this case, as indicated by arrow 762, the fluoroscopic image 710 shows the position of the pressure-sensing guidewire along the path 740, and therefore, as indicated by arrow 763, the pressure data 730 is associated with a position 741 along the path 740. Finally, by superimposing the path 740 onto the associated data on the fluoroscopic image 711, the pressure data 730 is associated with the position in the fluoroscopic image 710 where the pressure data 730 was acquired. Route 740 itself may or may not be displayed on image 711.

[0085]

[0102] In some embodiments, the coregistrated iFR data is associated with contrast-enhanced (visible) X-ray images so that the location where the iFR data is acquired is perceived relative to its location along the blood vessel.

[0086]

[0103] Figure 8 is a schematic diagram illustrating the relationship between a fluoroscopic image 810, an intravascular ultrasound image 830, and a path 840 defined by the movement of an intravascular device, according to an aspect of this disclosure. Figure 8 illustrates a method for co-registrating intravascular data 830, including intravascular images, with corresponding locations on one or more fluoroscopic images 810 of the same region of the patient's anatomical site. The aspect of co-registrating intravascular data 830, including IVUS images, is similar to the concept described with reference to Figure 7.

[0087]

[0104] Specifically, while the physician performs a pullback with the intravascular device 820, for example, while the intravascular device 820 moves through the blood vessels of the anatomical site, the X-ray device images the patient's anatomical site. The intravascular device is substantially similar to the intravascular device 102 described with reference to Figure 1C. The X-ray device used to acquire the fluoroscopic image 810 is substantially similar to the X-ray device 152 in Figure 1B. In some embodiments, the fluoroscopic image 810 is acquired in the absence of contrast agent in the patient's vascular system. Such embodiments are shown by the fluoroscopic image 810 in Figure 8. In other embodiments, contrast agent is present in the patient's vascular system. In this respect, the fluoroscopic image 810 is alternatively an angiographic image or any preferred type of extraluminal image. The radiopaque portion of the intravascular device 820 is visible in the fluoroscopic image 810. The fluoroscopic image 810 corresponds to a continuous 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 the fluoroscopic image 810 is acquired using an X-ray source 160 and an X-ray detector 170 positioned at any suitable angle relative to the anatomical site of the patient. This angle is indicated by angle 890.

[0088]

[0105] The intravascular device 820 is any suitable intravascular device. As the intravascular device 820 moves through the patient's vascular system, the X-ray imaging system acquires multiple fluoroscopic images 810 showing the radiopaque portion of the intravascular device 820. Thus, each fluoroscopic image 810 shown in Figure 8 depicts the intravascular device 820 positioned at various locations, allowing the processor circuitry to track the position of the intravascular device 820 over time.

[0089]

[0106] As the intravascular device 820 is pulled through the patient's vascular system, 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 is any preferred data, including IVUS images, OCT images, intravascular photoacoustic (IVPA) images, any other arbitrary measurements or metrics related to luminal structure, or other physiological data acquired during the pullback of the intravascular device.

[0090]

[0107] As the physician pulls a pressure-sensing guidewire through the patient's vascular system, each intravascular data point 830 acquired by the intravascular device 820 is associated with a location within the patient's anatomical region in the fluoroscopic image 810, as indicated by the arrow 861. For example, the first IVUS image 830 shown in Figure 8 is associated with the first fluoroscopic image 810. The first IVUS image 830 is an image acquired by the intravascular device 820 at a location within the vascular system, 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 at a new location in the image 810, and so on. The processor circuit identifies the location of the intravascular device 820 in each acquired X-ray image 810 by any preferred method. For example, the processor circuit performs a variety of image processing techniques, such as edge recognition of radiopaque markers, pixel-level analysis to identify transitions between bright and dark pixels, filtering, or any other preferred technique to locate the imaging device 820. In some embodiments, the processor circuit uses a variety of artificial intelligence methods, including deep learning techniques such as neural networks or any other preferred technique, to locate the imaging device 820 in the X-ray image 810.

[0091]

[0108] During the device pullback, any preferred number of IVUS images or other intravascular data points 830 are acquired, and any preferred number of fluoroscopic images 810 are acquired. In some embodiments, there are fluoroscopic images 810 and intravascular data 830 in a 1:1 ratio. In other embodiments, there are different numbers of fluoroscopic images 810 and / or intravascular data 830.

[0092]

[0109] Furthermore, system 100 generates a fluoroscopy-based 2D path 840 defined by the position of the intravascular device 820 in the fluoroscopic image 810. The various positions of the intravascular device 820 during pullback shown in the fluoroscopic image 810 define the 2D path 840 as indicated by the arrow 860. The fluoroscopy-based 2D path 840 reflects the path of one or more radiopaque portions of the intravascular device 820 as it moves through the patient's vascular system, as observed by the X-ray imaging device 152 from angle 890. The fluoroscopy-based 2D path 840 defines the path measured by the X-ray device that acquired the fluoroscopic image 810, and therefore shows the path from the same angle 890 when the fluoroscopic image was acquired. In other words, the 2D path 840 represents the 3D path followed by the device projected onto the imaging plane at the imaging angle 890. In some embodiments, the path 840 is determined by the average of the detected positions of the intravascular device 820 within the fluoroscopic image 810. For example, the path 840 does not strictly coincide with the guidewire within any fluoroscopic image 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 Figures 1-4. In some embodiments, the path 840 is not visible to the user. For example, each IVUS image 830 is associated with a specific coordinate within image 811. In this way, the pressure data 830 is directly correlated to image 811. The group of all coordinates associated with the pressure data 830 defines the path 840. In this way, the IVUS image is directly associated with a portion or location within the roadmap image 811.

[0093]

[0110] As indicated by arrow 862, the two-dimensional path 840 is generated based on the fluoroscopic images 810, so each location along the two-dimensional path 840 is associated with one or more fluoroscopic images 810. For example, at location 841 along the path 840, the first fluoroscopic image 810 depicts the intravascular device 820 at the same location 841. In addition, as indicated by arrow 861, a correspondence is established between the fluoroscopic images 810 and the intravascular data 830, so the intravascular data 830, such as the shown IVUS image, is also associated with location 841 along the 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 preferred fluoroscopic image 811 (e.g., one of the fluoroscopic images 810 in the fluoroscopic image stream). In this way, any position along the path 840 displayed on the fluoroscopic image 811 is associated with IVUS data such as the IVUS image 830, as indicated by arrow 864. For example, the IVUS image 830 shown in Figure 8 is acquired simultaneously with the shown fluoroscopic image 810, and these two images are associated with each other as indicated by arrow 861. In this case, as indicated by arrow 862, the fluoroscopic image 810 shows the position of the intravascular device 820 along the path 840, and therefore, as indicated by arrow 863, the IVUS image 830 is associated with position 841 along the path 840. Finally, by superimposing the path 840 onto the associated data on the fluoroscopic image 811, the IVUS image 830 is associated with the position in the fluoroscopic image 810 where the IVUS image 830 was acquired. Route 840 itself may or may not be displayed on image 811.

[0095]

[0112] In the embodiment illustrated in Figure 8, the coregistrated IVUS image is associated with one of the fluoroscopic images acquired without contrast agent, such that the location where the IVUS image is acquired is perceived relative to a location along the guidewire. In other embodiments, the coregistrated IVUS image is associated with an X-ray image acquired with contrast agent (in which the blood vessels are visible), such that the location where the IVUS image is acquired is perceived relative to a location along the blood vessels.

[0096]

[0113] Figure 9 is a schematic diagram illustrating the relationship between an intravascular image colregistrated to an extraluminal image, pressure data colregistrated to an extraluminal image, and a longitudinal view based on the intravascular image and pressure data, according to an aspect of this disclosure. Specifically, Figure 9 shows the relationship between a roadmap fluoroscopic image 711 and colregistrated iFR data 730 (Figure 7), and a roadmap fluoroscopic image 811 and colregistrated IVUS imaging data 830 (Figure 8). Thus, Figure 9 illustrates a method for colregistrating iFR data 730 and IVUS images 830 from the same anatomical region of a patient.

[0097]

[0114] In some embodiments, physiological data is superimposed on IVUS cross-sectional images (e.g., ILD). Coregistration of physiological data and IVUS data allows users to better understand the overall situation of the imaged and / or measured sections of the blood 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). By coregistrating imaging data and physiological data to and / or each other in angiographic images, physicians can not only more easily understand the anatomical location of the patient's coronary arteries but also identify the optimal treatment route.

[0098]

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

[0099]

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

[0100]

[0117] In an embodiment where iFR data and IVUS images are each associated with two-dimensional coordinates that identify a location within roadmap image 711 or roadmap image 811, iFR data and IVUS images acquired at the same location along a blood vessel are co-registered on the basis that they have the same or substantially similar two-dimensional coordinates. In this embodiment, roadmap image 711 and roadmap image 811 are the same or substantially the same image.

[0101]

[0118] In an embodiment where each of the iFR data and IVUS image is 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 coordinates of the iFR data to the same position in the IVUS image. In this embodiment, roadmap image 711 and roadmap image 811 are either the same image or different images.

[0102]

[0119] The relationship between route 740 and the associated iFR data and its position along the patient's blood vessel, as well as the relationship between route 840 and the associated IVUS image data and its position along the same blood vessel, allows the iFR data and IVUS image data to be displayed together at the same position along the blood vessel, as shown by the longitudinal view 910 of the body cavity and the superimposed data in Figure 9. The longitudinal view may be called the Image Longitudinal Display (ILD) or Inline Digital (ILD) view.

[0103]

[0120] The acquired IVUS images are used to create an ILD910. In this respect, the IVUS images are tomographic or radial cross-sectional views of the blood vessel. The ILD910 provides a longitudinal cross-sectional view of the blood vessel. The ILD910 is a stack of IVUS images acquired at various locations along the blood vessel such that the longitudinal view of the ILD910 is perpendicular to the radial cross-sectional views of the IVUS images. In such embodiments, the ILD910 indicates the length of the blood vessel, and each IVUS image is a single radial cross-sectional image at a given location along the length. In another embodiment, the ILD910 is a stack of IVUS images acquired over time during the imaging procedure, and the length of the ILD910 represents the time or duration of the imaging procedure. The ILD910 is generated and displayed in real time or near real time during the pullback procedure. Each time an additional IVUS image is acquired, that image is added to the ILD910. For example, at some point during the pullback procedure, the ILD910 shown in Figure 9 is partially complete. In some embodiments, the processor circuit generates an illustration of a longitudinal view of the imaged vessel based on the received IVUS image. For example, the illustration does not display actual vessel image data as in the ILD910, but rather a stylized version of the vessel, such as solid lines indicating the lumen and vessel boundaries.

[0104]

[0121] As an example, index 912 identifies a location along a blood vessel, as shown in ILD910. This index 912 simultaneously corresponds to location 741 along pathway 740 and the same location 841 along pathway 840. As a result, the IVUS image acquired at location 841 is displayed at the location of index 912 as part of ILD910, as shown by arrow 961. Similarly, the iFR value associated with location 741 is superimposed on ILD910 at the same location of index 912, as shown by arrow 963.

[0105]

[0122] All acquired iFR values ​​associated with path 740 are superimposed on ILD910. An example of how the iFR values ​​are displayed to the user is shown by line 914. The plot is superimposed on ILD910 as shown by indices 918 and 920. For example, the minimum iFR value corresponds to indice 920, and the maximum value corresponds to indice 918. The vertical position of line 914 on ILD910 corresponds to the iFR value being some value between the minimum and maximum values. For example, at the most distal position along ILD910, the pressure data is at its minimum, as indicated by line 914 being located near the bottom of ILD910 and being in a straight line or the same vertical position as the minimum value 920. Similarly, at the proximal end, the pressure data is at its maximum. This is indicated by line 914 being at the top of ILD910 and being in a straight line or the same vertical position as the maximum value 918. In some embodiments, the user selects a portion of line 914 and / or line 916 (described later), and the system 100 displays to the user the iFR value associated with the selected location. The system 100 also displays the iFR value for the location of index 912.

[0106]

[0123] System 100 performs any preferred processing of iFR data or IVUS imaging data. For example, the system's processor circuit 510 performs averaging, smoothing, segmentation, grouping, or any other preferred data processing before or after the data is displayed to the user. In one example, line 914 shown in Figure 9 represents processed iFR data. Circuit 510 is also configured to display raw iFR data simultaneously. Raw iFR data is indicated by lines. The visual representations of raw iFR data and processed iFR data are visually distinguished by any means, such as different colors, patterns, transparency, or other forms of emphasis or differentiation. Processor circuit 510 displays lines 914 and 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 pressure-sensing device), the length of a recommended stent, the length between points of interest, or any other arbitrary length. Length determinations are performed automatically by the processor circuit 510 or in response to user input. Length determinations are performed at least partially based on the radiopaque segment of a pressure-sensing wire. For example, the radiopaque segment of a guidewire is of 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 segment of an IVUS imaging device. For example, in some embodiments, the transducer segment of an intravascular imaging device is constructed from radiopaque material and has known dimensions. Additional markers of known lengths 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. Furthermore, errors exist in the position data along the physiological pullback. Since the IVUS position data and physiological data are colregistrated to extraluminal images that are colregistrated to each other, errors in both the IVUS pullback position information and the physiological pullback information are stacked. To relate 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, helping the user easily understand the presence and amount of errors associated with the displayed position data.

[0109]

[0126] Figure 10 is a schematic diagram of an image-based longitudinal view of a lumen with correlated pressure data according to an aspect of the present disclosure. Figure 10 shows a depiction of stent 1010 along the ILD. In this view, stent 1010 may be superimposed on the ILD 910. The processor circuit 510 automatically makes recommendations for stent placement. These recommendations include the type of stent, the length of the stent, the diameter of the stent, the proximal and distal landing zones of the stent, and the number of recommended stents, or any other preferred stent parameters. In some embodiments, the stent recommendations are based on iFR data, IVUS imaging data, the location of the side branches of the imaged / measured vessel, the distance between consecutive stents or between stents in series, or any other factor. Embodiments of 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 depiction of stent 1010 represents a virtual stent or a planned stent. In some embodiments, the depiction of virtual stent 1010 may be manually positioned by user input via a user input device (e.g., a touchscreen display, mouse / keyboard, etc.). For example, the processor circuit 510 is configured to receive user input providing instructions for adjusting the position, length, etc., of the stent. The user determines the stent position or other features of the stent based on iFR data and / or IVUS imaging data depicted on line 914. In other embodiments, the graphical element 1010 superimposed on ILD 910 is any other preferred treatment rather than a stent. For example, graphical element 1010 represents an angioplasty device, a balloon, an atheroma removal device, or any other therapeutic device.

[0110]

[0127] In some embodiments, line 914 is referred to as the 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 intravascular pressure measurements. In some embodiments, line 914 represents the iFR value. In some embodiments, the iFR value corresponding to line 914 is based on pressure measurements obtained by a distal pressure guidewire and pressure measurements obtained simultaneously by a proximal pressure sensor, such as a pressure sensor placed on a guide catheter. In some embodiments, the pressure device measuring the iFR value is located in the renal artery, with a pressure sensor placed on the pressure guidewire receiving measurements in the renal artery and a pressure sensor placed on a guide catheter located in the aorta receiving measurements of pressure in the aorta. In some embodiments, the proximal or distal pressure measurement is performed by the aortic catheter. Thus, the value of line 914 corresponds to the pressure ratio between any two of these pressure sensors.

[0111]

[0128] Figure 10 also shows region 1014. As shown in Figure 10, line 914, corresponding to the iFR data, terminates proximal to region 1014. This is because region 1014 was imaged by the IVUS imaging device but not measured by the pressure-sensing guidewire. As a result, region 1014 represents the imaging-based division of the ILD but does not include the superimposed iFR data. Therefore, in the example shown in Figure 10, region 1014 corresponds to region 614 shown and explained with reference to Figure 6.

[0112]

[0129] Region 1015 is also shown in Figure 10. The image data included as part of ILD910 is shown to terminate distal to region 1015. This is because region 1015 was measured by the pressure-sensing guidewire but not imaged by the IVUS device. As a result, region 1015 shows iFR data for lines 914 and / or 916, but does not show image-based data corresponding to the data acquired by the IVUS imaging device. Therefore, in the example shown in Figure 10, region 1015 corresponds to region 615 shown and explained 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 only by the intravascular device or pressure pullback device. As a result, the system performs various calibration procedures to ensure that the location of the intravascular image data coincides with the location of the corresponding pressure data. For example, the system performs calibration to ensure that the pressure data is colregistrated to the same location as the corresponding IVUS data. In some cases, as shown in the upper right of ILD910 (e.g., region 1015), the physiological pullback length (e.g., path 603) is longer than the IVUS pullback length (e.g., path 605). Since both the physiological pullback and IVUS pullback paths start from a reference point that can be offset or calibrated, the location along the physiological pullback coincides with the location along the IVUS pullback. As an example, an intraluminal image (e.g., an IVUS image) is correlated to a first corresponding location along the patient's body cavity by one of the aforementioned colregistration steps. Intraluminal physiological measurements (e.g., iFR measurements) are similarly correlated to a second corresponding location along the same body cavity in the patient. In this example, one, some, or all of the first locations in the intraluminal images are the same as or different from one, some, or all of the second locations in the intraluminal physiological measurements. In some embodiments, the intraluminal images and physiological measurements correspond to the same location along the body cavity.

[0114]

[0131] Figure 11 is a schematic diagram of an image-based longitudinal view 1110 of a lumen with co-registered pressure data according to an aspect of the present disclosure. Figure 11 shows an additional method for displaying iFR data superimposed on an ILD (e.g., ILD1110). As shown in Figure 11, a plurality of points 1114 are superimposed on the ILD1110. The ILD1110 is substantially similar to the ILD910 shown previously.

[0115]

[0132] In the embodiment shown in Figure 11, each point 1114 corresponds to a change in the pressure ratio (e.g., iFR). For example, in some embodiments, the presence of one point 1114 in a given location corresponds to a change in the pressure ratio of 0.01. A point 1114 can be associated with any preferred change in the pressure ratio other than 0.01. This value is determined by the processor 510 or the user of the system 100. Points 1114 superimposed on the ILD 1110 are placed in any preferred location, such as on the ILD 1110, adjacent to the ILD 1110, or superimposed on any other location.

[0116]

[0133] It should be further noted that point 1114 can be any preferred appearance. In particular, point 1114 is shown and described in this disclosure as a round point for educational purposes only. For example, point 1114 can be any preferred shape, pattern, size, or any other preferred visual appearance.

[0117]

[0134] Figure 12 is a schematic diagram of a measured-based longitudinal view 1210 of a lumen having correlated pressure data according to an aspect of the present disclosure. Figure 12 shows an additional method of displaying iFR data superimposed on an ILD (e.g., ILD 1210). As shown in Figure 12, a plurality of points 1114 are superimposed on the ILD 1210.

[0118]

[0135] In some embodiments, ILD1210 includes a stylized ILD. In particular, a stylized ILD is an ILD that is generated based on luminal measurements rather than on IVUS images. As an example, referring to Figure 11, ILD1110 is primarily based on IVUS images, while stylized ILD1210 is based on intraluminal measurements of the imaged vessel and / or lumen. For example, stylized ILD1210 includes lines 1212 and 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 received IVUS image 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., 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 position along the vessel. These averaged diameters are associated with each IVUS image and with each location along the path 840 (Figure 8). Lines 1212 are then generated as symmetrical lines centered on the central line along the ILD 1210, and are spaced apart from each other based on the average diameter of the vessel wall at that location. This allows the 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, the ILD 1210 is referred to as the 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 vessel. For example, the processor circuit 510 automatically identifies the lumen boundary in each received IVUS image during the imaging procedure. The 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 distance from the lumen boundary to the catheter), the processor circuit determines the average diameter of the lumen boundary in each IVUS image. These averaged diameters are associated with each IVUS image and with their respective positions along the path 840 (Figure 8). Line 1214 is then generated as a symmetrical line centered on the centerline along the ILD 1210 and spaced apart from each other based on the average diameter of the lumen boundary at its position. This allows the user of system 100 to easily view the lumen boundary along the imaged segment of the 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, with 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, with Jon D. Klingensmith, D. Geoffrey Vince, and Raj Shekhar as inventors; and "SYSTEM AND METHOD OF CHARACTERIZING VASCULAR," issued on July 11, 2006, with Anuja Nair, D. Geoffrey Vince, Jon D. Klingensmith, and Barry D. Kuban as inventors. U.S. Patent No. 7,074,188, titled "TISSUE", U.S. Patent No. 7,175,597, titled "NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD", issued on February 13, 2007, with D. Geoffrey Vince, Anuja Nair, and Jon D. Klingensmith as inventors, U.S. Patent No. 7,215,802, titled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION", issued on May 8, 2007, with Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince as inventors, and "SYSTEM AND METHOD FOR IDENTIFYING A VASCULAR U.S. Patent No. 7,359,554, entitled "BORDER", and issued on December 9, 2008, by Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D.This includes U.S. Patent No. 7,463,759, entitled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," issued with Geoffrey Vince as the inventor; the teachings of these patents are incorporated herein by reference in their entirety.

[0121]

[0138] Lines 1212 and 1214 are displayed to the user simultaneously or separately, as shown in Figure 12. When displayed simultaneously, the user can easily identify the diameter of the vessel wall at any position along the imaged vessel by comparing it to the diameter of the lumen boundary, and can easily and quickly assess the degree of stenosis within the imaged vessel. Lines 1212 and 1214 are distinguished from each other using any of the methods described herein.

[0122]

[0139] As shown in Figure 12, points 1114 are superimposed on the stylized ILD 1210. Points 1114 are the same as those described with reference to Figure 11. The combination of the stylized depiction of the vessel wall (e.g., line 1212), the stylized depiction of the lumen boundary (e.g., line 1214), and points 1114 representing changes in the pressure ratio along the vessel provides the user of 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 vessels requiring treatment and determine what type of treatment is needed.

[0123]

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

[0124]

[0141] Furthermore, it should be noted that pressure data can be displayed in conjunction with the ILD1210 in any format. For example, lines similar to lines 914 and / or 916 can be superimposed on the measured-value-based ILD1210. In this way, the plotting style that displays the pressure ratio data shown and described with reference to Figures 9 and 10, including lines 914 and 916 and indices 918 and 920, can also be superimposed on the stylized ILD shown in Figure 12. For example, the stylized ILD1210 includes point 1114, and / or lines 914 and 916 and the accompanying indices 918 and 920. Any ILD described herein includes any of the formats of pressure change data described or shown herein.

[0125]

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

[0126]

[0143] In some embodiments, stent 1315 corresponds to a virtual stent automatically recommended by the processor circuit 510 in accordance with the principles outlined with reference to Figure 10. Stent 1320 corresponds to a virtual stent manually placed by a user of the system. The system 100 provides the user with a graphical user interface that allows the user to select a stent of any type or size and place it at any location along the ILD 1310. In this way, the user plans the stent deployment using the ILD 1310 (or other ILDs described herein).

[0127]

[0144] In some embodiments, after a virtual stent (e.g., stents 1010, 1315, or 1320) is recommended, selected, specified, or displayed, the system predicts virtual changes in pressure data. For example, the system generates modified versions of lines 914 and 916 (Figure 9) and / or point 1114 (Figure 11) that show the predicted changes in pressure data. Embodiments of predicting changes in pressure data for virtual stents include various features, including those 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 have been previously incorporated. In some embodiments, the predicted modified pressure data is displayed simultaneously with the preprocessing 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 preprocessed data.

[0128]

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

[0129]

[0146] The processor circuit 510 is configured to co-registrate any intraluminal data (including IVUS images or iFR pressure ratio data) to a path (e.g., path 740 and / or path 840). For example, IVUS imaging data and / or physiological data are associated with locations along the path. When the path is superimposed on an extraluminal image, the intraluminal data is displayed corresponding to its location in the extraluminal image, indicating at which location along the blood vessel indicated by the path the intraluminal data was acquired. As previously mentioned, intraluminal physiological data is superimposed on a longitudinal view of the body cavity. As shown in Figure 14, both the extraluminal image with the co-registrated intraluminal data and the longitudinal view with the co-registrated physiological data are displayed on the same screen.

[0130]

[0147] As an example, the graphical user interface 1400 provides an X-ray image 1410, an IVUS image 1430, physiological data 1490, and a longitudinal view 1450 of the imaged vessel. The X-ray image 1410 includes a depiction of a path 1440. Path 1440 is similar to path 740 in Figure 7 and / or path 840 in Figure 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 Figure 14 and further described in detail with reference to Figure 15, various indices related to the co-registered intraluminal data are displayed along or next to this path 1440.

[0131]

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

[0132]

[0149] The graphical user interface 1400 also displays an IVUS image 1430. In this respect, multiple IVUS images (including image 1430) can be co-registered to the path 1440. IVUS image 1430 is an IVUS image acquired at a location identified by index 1422. Alternatively, IVUS image 1430 is an IVUS image acquired at a location identified by index 1494. In some embodiments, IVUS image 1430 includes a boundary 1432. This boundary is automatically identified by the processor circuit 510 or identified by the user of the system. In some embodiments, the boundary 1432 is a luminal boundary, a vascular boundary, a stent boundary, or other boundary in 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, with 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, with Jon D. Klingensmith, D. Geoffrey Vince, and Raj Shekhar as inventors; and "SYSTEM AND METHOD OF CHARACTERIZING VASCULAR," issued on July 11, 2006, with Anuja Nair, D. Geoffrey Vince, Jon D. Klingensmith, and Barry D. Kuban as inventors. U.S. Patent No. 7,074,188, titled "TISSUE", U.S. Patent No. 7,175,597, titled "NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD", issued on February 13, 2007, with D. Geoffrey Vince, Anuja Nair, and Jon D. Klingensmith as inventors, U.S. Patent No. 7,215,802, titled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION", issued on May 8, 2007, with Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince as inventors, and "SYSTEM AND METHOD FOR IDENTIFYING A VASCULAR U.S. Patent No. 7,359,554, entitled "BORDER", and issued on December 9, 2008, by Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D.This includes U.S. Patent No. 7,463,759, entitled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," issued with Geoffrey Vince as the inventor; the teachings of these patents are incorporated herein by reference in their entirety.

[0134]

[0151] Interface 1400 also depicts metrics 1434. The metrics 1434 relate to the shown IVUS image 1430, particularly the boundary 1432. For example, the processor circuit 510 automatically calculates various metrics 1434 related to the boundary 1432. For example, the processor circuit 510 identifies the cross-sectional area of ​​the boundary 1432. The circuit also identifies the minimum diameter of the boundary, the maximum diameter of the boundary, or any other arbitrary measurement or metric related to the boundary 1432, or other aspects of the image 1430.

[0135]

[0152] In some embodiments, a longitudinal view 140 is also displayed. The longitudinal image 1450 is referred to as an inline 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 this respect, the IVUS image is a tomographic or radial section of the vessel. The ILD 1450 provides a longitudinal section of the vessel. The ILD 1450 is a stack of IVUS images acquired at various locations along the vessel such that the longitudinal view of the ILD 1450 is perpendicular to the radial section of the IVUS image. In such embodiments, the ILD 1450 indicates the length of the vessel, and the individual IVUS images are single radial section images at a given location along the length. In another embodiment, the ILD 1450 is a stack of IVUS images acquired over time during the imaging procedure, and the length of the ILD 1450 represents the time or duration of the imaging procedure. The ILD1450 is generated and displayed in real time or near real time during the pullback procedure. Each time an additional IVUS image is acquired, that image is added to the ILD1450. For example, at some point during the pullback procedure, the ILD1450 shown in Figure 14 is partially complete. In some embodiments, the processor circuitry generates an illustration of a longitudinal view of the imaged vessel based on the received IVUS images. 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 shown in Figure 11, the ILD1450 represents a stylized ILD showing the lumen boundary 1156 extending as a solid line across the ILD1450. The position of the lumen boundary 1156 is symmetrically arranged around a central axis, according to the lumen diameter calculated in each corresponding IVUS image.

[0136]

[0153] ILD1450 includes iFR data 1492, various length measurements 1462, indicators 1452 and 1456 that identify the start and end of the length measurements, and a description of a bookmark identifier 1454.

[0137]

[0154] In some embodiments, iFR data 1492 is the same iFR data used to input the described metric 1490. As shown in ILD 1450, and since ILD 1450 is generated based on IVUS data, when two intraluminal procedures (e.g., IVUS data and physiological data) are performed and co-registered to the same path (e.g., path 1440), the same IVUS data and physiological data are co-registered to each other, as shown by iFR data 1492 located along ILD 1450. iFR data 1492 is similar to line 914 described with reference to Figure 10. ILD 1450 further includes iFR data 1493. In some embodiments, iFR data 1493 corresponds to raw iFR data and iFR data 1492 corresponds to processed iFR data. iFR data 1493 is similar to line 916 described with reference to Figure 10.

[0138]

[0155] ILD1450 includes additional or alternative physiological measurement data other than iFR data 1492 and 1493. For example, the physiological data superimposed on ILD1450 includes points similar to point 1114 shown and described with reference to Figures 11 and 12. In addition, ILD1450 is either 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] Length measurements along the ILD1450 are generated automatically by the user of the system 100 and / or by the processor circuit 510. For example, the user selects various locations along the ILD1450, and the processor circuit calculates the length measurements corresponding to the selected locations. These various length measurements are displayed near the ILD1450 as measurement references 1460. In some embodiments, the length measurements are distinguished from one another by labels, colors, patterns, highlights, or other visual features.

[0140]

[0157] Indicators 1452 and 1456 are user-selected positions along the ILD 1450. In some embodiments, the indices are selected automatically. For example, indices 1452 and 1456 identify the start and end positions of the length measurement. In some embodiments, indices 1452 and 1456 correspond to the distal and proximal landing zones of the stent being considered by the physician. The iFR estimate in the physiological data 1490 is the iFR value predicted based on indices 1452 and 1456 with the proposed stent placed in the vessel. In some embodiments, the corresponding indices are displayed at the corresponding positions along the 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 located at corresponding positions along the path 1440 of the image 1410.

[0142]

[0159] In the screen display 1400, an index 1470 is provided superimposed on the X-ray image 1410. The index 1470 indicates to the user that the X-ray image is a zero-contrast image frame.

[0143]

[0160] Figure 15 is a schematic diagram of a graphical user interface 1500 according to an aspect 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] The extraluminal image 1510 is an X-ray image. Image 1510 is an image acquired with or without the introduction of contrast agent into the patient's vascular system. In some embodiments, the X-ray image 1510 shows the same view of the vessel as shown in the IVUS image 1530 and the longitudinal view 1550. Image 1510 includes a roadmap 1512 and several points 1514. The roadmap 1512 corresponds to the position where the IVUS imaging device has advanced in image 1510. The roadmap 1512 is similar to any of the roadmaps described herein, including, for example, roadmap 740 in Figure 7 and / or roadmap 840 in Figure 8. In some embodiments, a position along the roadmap 1512 corresponds to a position in the longitudinal view 1550. For example, a distal position 1516 along the roadmap 1512 corresponds to a distal position 1553 in the longitudinal view 1550. In this example, position 1516 in the X-ray image 1510 and position 1556 in the longitudinal view 1550 correspond to the same location within the patient's body cavity.

[0145]

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

[0146]

[0163] In some embodiments, point 1514 in 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 points 1514 indicates to the user the speed at which a device, such as a physiological measurement device, has traveled through the blood vessel. For example, a larger spacing between adjacent points 1514 corresponds to a faster speed. Similarly, a smaller spacing between adjacent points 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 Figure 15, index 1522 identifies a location along path 1512 corresponding to IVUS image 1530. Specifically, index 1522 identifies the location along path 1512 from which IVUS image 1530 was acquired. An additional index 1524 is shown near index 1522. Index 1524 identifies the iFR value corresponding to the same location as index 1522 for the user. In some embodiments, index 1524 displays any other arbitrary physiological measurement. An intravascular pressure data index 1582 is also placed within image 1510. Index 1582 corresponds to pressure measurements acquired along the length of the vessel. Index 1582 corresponds to either or both of the ILD 1550 data 1592 and / or 1593. In some embodiments, index 1582 indicates a change in pressure along the vessel. For example, the presence of a single index 1582 corresponds to a predetermined change in pressure, such as an iFR change of 0.01. Indicator 1582 is displayed as a line perpendicular to the blood vessel, adjacent to the blood vessel in image 1510.

[0149]

[0166] Furthermore, additional data 1590 is shown superimposed on image 1510. Data 1590 corresponds to physiological measurements acquired within the blood vessel. In some embodiments, data 1590 includes mean, maximum, minimum values, or any other arbitrary values ​​corresponding to the physiological measurements. In some embodiments, data 1590 also includes data corresponding to IVUS measurements. For example, data 1590 corresponds to the diameter or area of ​​the blood vessel wall, the diameter or area of ​​the lumen, plaque load, or any other arbitrary values ​​corresponding to IVUS images acquired at any location within the blood vessel.

[0150]

[0167] The longitudinal view 1550 shown in Figure 15 is an ILD. The ILD 1550 includes any features similar to those described with reference to other ILDs in this application. For example, the ILD 1550 is 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. Thus, the index 1580 corresponds to the index 1524 of the image 1510. In some embodiments, when the 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 the user moves the index 1580, the index 1522 moves to the corresponding location and a new IVUS image is displayed.

[0151]

[0168] Furthermore, lines 1592 and 1593 are shown superimposed on the 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 is similar to any of the physiological measurement indices, lines, or points described in this application.

[0152]

[0169] Figure 16 is a flowchart of a method 1600 for colregistrating intraluminal physiological data to longitudinal images of a body cavity, according to an aspect of the present disclosure. Method 1600 describes automated segmentation of a vessel for detecting a segment of interest using colregistration of invasive physiology with radiographic images. As shown in the figure, 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 may be omitted, performed in a different order, or performed simultaneously. The steps of Method 1600 are performed by any preferred component within the diagnostic system 100, and not all steps need to be performed by the same component. In some embodiments, one or more steps of Method 1600 are performed by a processor circuit of the diagnostic system 100, including, for example, a processor 560 (Figure 5) or any other component, or according to the instructions of the processor circuit.

[0153]

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

[0154]

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

[0155]

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

[0156]

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

[0157]

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

[0158]

[0175] Those skilled in the art will recognize that the apparatus, systems, and methods described above can be modified in various ways. Accordingly, those skilled in the art will understand that the embodiments contained herein are not limited to the specific exemplary embodiments described above. In this regard, while exemplary embodiments are shown and described, the aforementioned disclosure intends to allow for a wide range of modifications, alterations, and substitutions. It should be understood that such variations are made with respect to the foregoing without departing from the scope of the disclosure. Accordingly, it is appropriate that the appended claims be interpreted broadly in a manner consistent with the disclosure.

Claims

1. An intravascular imaging catheter for intravascular ultrasound (IVUS) or optical coherence tomography (OCT), Intravascular pressure sensing guidewire, The processor circuit includes the intravascular imaging catheter and the intravascular pressure sensing guidewire, and the processor circuit is The intravascular imaging catheter is controlled to acquire multiple intravascular images while it is moving through the patient's blood vessels. The plurality of intravascular images are co-registrated to a first corresponding position along the blood vessel, Based on the coregistration of the plurality of intravascular images, the starting position of the movement of the intravascular imaging catheter and the length the intravascular imaging catheter has advanced along the blood vessel during the movement of the intravascular imaging catheter are identified. Control the intravascular pressure sensing guidewire to acquire multiple intravascular pressure measurements while the intravascular pressure sensing guidewire is moving through the blood vessel. The plurality of intravascular pressure measurements are colregistrated to a second corresponding position along the blood vessel. Based on coregistration of the plurality of intravascular pressure measurements, the starting position of the movement of the intravascular pressure sensing guidewire and the length the intravascular pressure sensing guidewire has advanced along the blood vessel during its movement are identified. The offset between the starting position of the movement of the intravascular imaging catheter and the starting position of the movement of the intravascular pressure sensing guidewire is determined. The longitudinal view of the blood vessel is generated based on the plurality of intravascular images such that the longitudinal view of the blood vessel includes a stack of the plurality of intravascular images. A graphical representation is generated based on the aforementioned multiple intravascular pressure measurements. The display, which is in communication with the aforementioned processor circuit, The longitudinal view of the blood vessel, The graphical representation superimposed on the longitudinal view and Output a screen display that includes, A system in which the graphical representation is superimposed onto the longitudinal view based on the offset.

2. The graphical representation is superimposed on the longitudinal view such that the position along the graphical representation corresponds to the position along the longitudinal view. The system according to claim 1, wherein the position along the graphical representation and the position along the longitudinal view represent the same corresponding position along the blood vessel.

3. The graphical representation is The length to which the intravascular imaging catheter has advanced along the blood vessel, and The length along which the intravascular pressure sensing guidewire has advanced along the blood vessel The system according to claim 1, which is superimposed on the longitudinal view based on the above.

4. The aforementioned processor circuit further, Based on the coregistration of the multiple intravascular images, the end position of the movement of the intravascular imaging catheter is identified. Based on coregistration of the plurality of intravascular pressure measurements, the end position of the movement of the intravascular pressure sensing guidewire is identified. The aforementioned graphical representation is The starting position of the movement of the intravascular imaging catheter, The end position of the movement of the intravascular imaging catheter, The starting position of the movement of the intravascular pressure sensing guidewire, and The end position of the movement of the intravascular pressure sensing guidewire. The system according to claim 1, which is superimposed on the longitudinal view based on the above.

5. The system according to claim 1, wherein the graphical representation includes a plot based on the plurality of intravascular pressure measurements.

6. The processor circuit further calculates a plurality of pressure ratios using the plurality of intravascular pressure measurements, The system according to claim 5, wherein the plot based on the plurality of intravascular pressure measurements includes a plot of the plurality of pressure ratios.

7. The processor circuit generates a further graphical representation based on the plurality of intravascular pressure measurements. The aforementioned screen display includes the further graphical representation superimposed on the longitudinal view, The graphical representation includes an adjusted plot based on the multiple intravascular pressure measurements, The system according to claim 1, wherein the further graphical representation includes a raw plot based on the plurality of intravascular pressure measurements.

8. The processor circuit further calculates a plurality of pressure ratios using the plurality of intravascular pressure measurements, The system according to claim 1, wherein the graphical representation includes a plurality of shapes representing the amount of change between the plurality of pressure ratios.

9. The processor circuit receives user input from a user input device that is in communication with the processor circuit to select a portion of the longitudinal view. The system according to claim 1, wherein the screen display further includes an index superimposed on the longitudinal view for identifying a portion of the longitudinal view.

10. The aforementioned screen display is, Extraluminal image of the aforementioned blood vessel, An index of the length along the blood vessel through which the intravascular imaging catheter has advanced is superimposed on the extraluminal image, The extraluminal image is superimposed with the length indicator along the blood vessel as the intravascular pressure sensing guidewire progresses. The system according to claim 1, further comprising:

11. The aforementioned screen display is, Extraluminal image of the aforementioned blood vessel, One intravascular image from among the multiple intravascular images and The system according to claim 1, further comprising:

Images