Recording of intraluminal physiological data for longitudinal imaging of the body lumen using extraluminal imaging data

Abstract

System that includes the following: a processor circuit configured for communication with an intraluminal imaging device and an intraluminal physiological measurement device, wherein the processor circuit is configured to: Receiving a multitude of intraluminal images obtained from an intraluminal imaging device during the movement of the intraluminal imaging device through a patient's body lumen; Receiving a multitude of intraluminal physiological measurements obtained by the intraluminal physiological measuring device during the movement of the intraluminal physiological measuring device through the body lumen; Generating a longitudinal view of the body lumen based on the multitude of intraluminal images; Generating a graphical representation based on the multitude of intraluminal physiological measurements; and Output to a display in communication with the processor circuit, a screen display that includes: the longitudinal view of the body lumen; and the graphic representation that is overlaid on the longitudinal view.

Description

CROSS-REFERENCE TO RELATED REGISTRATIONS

[0001] This application claims the priority and benefit of patent application PCT / EP2022 / 084684, filed on December 7, 2022, which is hereby incorporated by reference in its entirety. TECHNICAL AREA

[0002] The present disclosure relates generally to the co-registration of data from different medical diagnostic modalities. In particular, physiological data, intravascular imaging data, and X-ray data are registered three times, and physiological data are superimposed over a longitudinal view of intravascular data. STATE OF THE ART

[0003] Physicians use many different medical diagnostic systems and instruments to monitor a patient's health and diagnose medical conditions. Different modalities of medical diagnostic systems can provide a physician with different images, models, and / or data about 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. Using multiple diagnostic systems to examine a patient's anatomy provides a physician with additional insights into the patient's condition.

[0004] In the field of intravascular imaging and physiological measurement, co-registration of data from invasive devices (e.g., intravascular ultrasound (IVUS) or instantaneous wave-free ratio (iFR) devices) with non-invasively acquired images (e.g., via X-ray angiography) is a powerful technique for improving the efficiency and accuracy of vascular catheterization procedures. Co-registration identifies the locations of intravascular data measurements along a blood vessel by mapping the data onto an angiographic image of the vessel. A physician can then potentially know precisely where in the vessel a measurement was taken, rather than having to estimate the location. Co-registration is particularly useful in the diagnosis and treatment of coronary artery disease (CAD). SUMMARY

[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. This allows a user to more easily understand the patient's anatomy and determine optimal treatment pathways. By displaying pressure data and intravascular imaging data at appropriate locations along a longitudinal view of the vessel to be treated, a physician can determine the appropriate treatment type, such as a stent, and the correct location for treatment along the vessel, such as proximal and distal landing zones for a stent, more quickly and accurately.

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

[0007] In an exemplary scenario, a system is provided. The system includes a processor circuit for communication with an intraluminal imaging device and an intraluminal physiological measurement device, the processor circuit being configured to: receive a multitude of intraluminal images acquired by an intraluminal imaging device as the intraluminal imaging device moves through a patient's body lumen; receive a multitude of intraluminal physiological measurements acquired by the intraluminal physiological measurement device as the intraluminal physiological measurement device moves through the body lumen; generate a longitudinal view of the body lumen based on the multitude of intraluminal images; and generate a graphical representation based on the multitude of intraluminal physiological measurements.Output to a display in communication with the processor circuit, a screen display, comprising: the longitudinal view of the body lumen; and the graphic representation superimposed on the longitudinal view.

[0008] In one aspect, the processor circuit is further configured to: co-register the multitude of intraluminal images at first corresponding positions along the body lumen; co-register the multitude of intraluminal physiological measurements at second corresponding positions along the body lumen; and the graphical representation based on the co-registration of the multitude of intraluminal images and co-registration of the multitude of intraluminal physiological measurements is overlaid on the longitudinal view. In one aspect, the graphical representation is overlaid on the longitudinal view such that a location along the graphical representation corresponds to a location along the longitudinal view, and the location along the graphical representation and the location along the longitudinal view represent the same corresponding position along the body lumen. In one aspect, the processor circuit is further configured to: identify,based on co-registering the multitude of intraluminal images, a starting position of the movement of the intraluminal imaging device, and a length along the body lumen traveled by the intraluminal imaging device during its movement; and identifying a starting position of the movement of the physiological measuring device and a length along the body lumen traveled by the physiological measuring device during its movement; wherein the graphical representation is overlaid on the longitudinal view, based on: the starting position of the movement of the intraluminal imaging device; the length along the body lumen traveled by the intraluminal imaging device; the starting position of the movement of the physiological measuring device; and the length along the body lumen,which the physiological measuring device travels. In one aspect, the processor circuit is further configured to determine an offset between the starting position of the movement of the intraluminal imaging device and the starting position of the movement of the physiological measuring device, so that the graphical representation is overlaid on the longitudinal view, based on: an offset; the length along the body lumen traveled by the intraluminal imaging device; and the length along the body lumen traveled by the physiological measuring device. In one aspect, the processor circuit is further configured to: identify, based on the co-registration of the multitude of intraluminal images,a starting position of the movement of the intraluminal imaging device and an end position of the movement of the intraluminal imaging device; and identifying a starting position of the movement of the physiological measuring device and an end position of the movement of the intraluminal physiological measuring device; wherein the graphical representation is overlaid on the longitudinal view, based on: the starting position of the movement of the intraluminal imaging device; the end position of the movement of the intraluminal imaging device; the starting position of the movement of the physiological measuring device; and the end position of the movement of the intraluminal physiological measuring device. In one viewpoint, the graphical representation includes a diagram based on the multitude of intraluminal physiological measurements. In one viewpoint, the intraluminal physiological measuring device includes an intravascular pressure measuring device.The multitude of intraluminal physiological measurements includes a multitude of intravascular pressure measurements. The processor circuit is further configured to calculate a multitude of pressure ratios using the multitude of intraluminal physiological measurements, and the graph based on the multitude of intraluminal physiological measurements includes a graph of the multitude of pressure ratios. From one perspective, the processor circuit is configured to generate a further graphical representation based on the multitude of intraluminal physiological measurements, with the screen display including the further graphical representation superimposed on the longitudinal view.wherein the graphical representation comprises a conditioned graph based on the multitude of intraluminal physiological measurements, and wherein the further graphical representation comprises a raw graph based on the multitude of intraluminal physiological measurements. In one aspect, the intraluminal physiological measuring device comprises an intravascular pressure measuring device, the multitude of intraluminal physiological measurements comprises a multitude of intravascular pressure measurements, the processor circuit is further configured to calculate a multitude of pressure ratios using the multitude of intraluminal physiological measurements, and the graphical representation comprises a multitude of shapes that are representative of an magnitude change between the multitude of pressure ratios. In one aspect, the processor circuit is configured to communicate with the processor circuit from a user device.to receive user input that selects a section of the longitudinal view; and the screen display further includes an indicator overlaid on the longitudinal view that identifies the section of the longitudinal view. In one viewpoint, the longitudinal view of the body lumen comprises an image-based longitudinal view encompassing the multitude of intraluminal images. In another viewpoint, the processor circuitry is configured to compute a multitude of measurements associated with the body lumen using the multitude of intraluminal images, and the longitudinal view of the body lumen comprises a measurement-based longitudinal view based on the multitude of measurements. In another viewpoint, the screen display further includes: an extraluminal image of the body lumen; an indicator of a length traveled by the intraluminal imaging device during movement of the intraluminal imaging device;wherein the indicator of the length traveled by the intraluminal imaging device is superimposed on the extraluminal image; and an indicator of the length traveled by the intraluminal physiological measuring device during the movement of the intraluminal imaging device, wherein the indicator of the length traveled by the intraluminal physiological measuring device is superimposed on the extraluminal image. In one aspect, the screen display further comprises: an extraluminal image of the body lumen; and an intraluminal image of the plurality of intraluminal images.

[0009] One possible sequence includes: receiving, with a processor circuit communicating with an intraluminal imaging device, a multitude of intraluminal images acquired by an intraluminal imaging device as it moves through a patient's body lumen; receiving, with the processor circuit, a multitude of intraluminal physiological measurements acquired by the intraluminal physiological measuring device as it moves through the body lumen; generating, with the processor circuit, a longitudinal view of the body lumen based on the multitude of intraluminal images; generating, with the processor circuit, a graphical representation based on the multitude of intraluminal physiological measurements;Output to a display in communication with the processor circuit, a screen display, comprising: the longitudinal view of the body lumen; and the graphic representation superimposed on the longitudinal view.

[0010] In an exemplary scenario, a system is provided. The system includes: an intravascular imaging catheter; a pressure-sensitive guidewire; a processor circuit configured to communicate with the intravascular imaging catheter and the pressure-sensitive guidewire, the processor circuit being configured to: receive multiple intravascular images obtained from the intravascular imaging catheter as it moves through a patient's blood vessel; receive multiple intravascular pressure measurements obtained from the pressure-sensitive guidewire as it moves through the blood vessel; generate a longitudinal view of the blood vessel based on the multiple intravascular images; and generate a graphical representation based on the multiple intravascular pressure measurements.Output to a display communicating with the processor circuit, a screen display, comprising: the longitudinal view of the blood vessel; and the graphic representation superimposed on the longitudinal view.

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

[0012] Illustrative embodiments of the present disclosure are described with reference to the accompanying drawings: Fig. Figure 1A is a schematic diagram of an intraluminal imaging, physiological measurement and X-ray system according to the aspects of the present disclosure. Fig. Figure 1B is a schematic diagram of an extraluminal imaging system according to the aspects of the present disclosure. Fig. Figure 1C is a schematic diagram of an intraluminal imaging device according to the aspects of the present disclosure. Fig. Figure 2 is a diagrammatic top view of an ultrasound imaging arrangement in a flat configuration according to the aspects of the present disclosure. Fig. Figure 3 is a diagrammatic perspective view of the ultrasound imaging setup in a configuration rolled around a support element according to the aspects of the present disclosure. Fig. Figure 4 is a diagrammatic cross-sectional side view of the ultrasound imaging arrangement according to aspects of the present disclosure. Fig. Figure 5 is a schematic diagram of a processor circuit according to the aspects of the present disclosure. Fig. Figure 6 is a diagrammatic view of a region of a patient's vascular system according to the aspects of the present disclosure. Fig. Figure 7 is a diagrammatic view of a relationship between X-ray fluoroscopy images, pressure data and a path defined by the movement of an intravascular device according to the aspects of the present disclosure. Fig. Figure 8 is a diagrammatic view of a relationship between X-ray fluoroscopy images, intravascular ultrasound images and a path defined by the movement of an intravascular device according to the aspects of the present disclosure. Fig. Figure 9 is a diagrammatic view of a relationship between intravascular images co-registered with an extraluminal image, pressure data co-registered with an extraluminal image, and a longitudinal view based on the intravascular images and pressure data according to the aspects of the present disclosure. Fig. Figure 10 is a diagrammatic view of an image-based longitudinal view of a lumen with co-registered print data according to aspects of the present disclosure. Fig. Figure 11 is a diagrammatic view of an image-based longitudinal view of a lumen with co-registered print data according to aspects of the present disclosure. Fig. Figure 12 is a diagrammatic view of a measurement-based longitudinal view of a lumen with co-registered pressure data according to aspects of the present disclosure. Fig. Figure 13 is a diagrammatic view of an image-based longitudinal view of a lumen with co-registered print data according to aspects of the present disclosure. Fig. Figure 14 is a diagrammatic view of a graphical user interface according to the aspects of the present disclosure. Fig. Figure 15 is a diagrammatic view of a graphical user interface according to the aspects of the present disclosure. Fig. Figure 16 is a flowchart of a method for co-recording intraluminal physiological data with a longitudinal image of a body lumen according to the aspects of the present disclosure. DETAILED DESCRIPTION

[0013] For the purpose of promoting an understanding of the principles of this disclosure, reference is now made to the embodiments illustrated in the drawings, and specific language is used to describe them. It is understood, however, that no limitation of the scope of protection of the disclosure is intended. All changes and further modifications to the described devices and systems, and any further application of the principles of this disclosure, are fully considered and included within this disclosure, as would normally occur to a person skilled in the art in the field to which the disclosure relates.In particular, it is fully taken into account that the features, components and / or steps described in relation to one embodiment can be combined with the features, components and / or steps described in relation to other embodiments of this disclosure. For the sake of brevity, however, the numerous iterations of these combinations are not described separately.

[0014] Fig. Figure 1A is a schematic diagram of an intraluminal imaging, physiological measurement, and X-ray system according to the aspects of the present disclosure. In some embodiments, the physiological measurement system, the intraluminal imaging system, and the extraluminal imaging system may comprise three separate systems or a combination of three systems: a physiological measurement system 101, an intraluminal imaging system 191, and an extraluminal imaging system 151. The physiological measurement system 101 obtains medical data about a patient's body while an intraluminal device is positioned within the patient's body. For example, the physiological measurement system 101 can control an intraluminal device to obtain intraluminal data from inside the patient's body while the intraluminal device is located within the patient's body.The intraluminal imaging system 191 also receives medical data about a patient's body while an intraluminal device is positioned inside the patient's body. For example, the intraluminal imaging system 101 can control an intraluminal device to obtain intraluminal data from inside the patient's body while the intraluminal device is located inside the patient's body. The extraluminal imaging system 151 receives medical data about the patient's body while the extraluminal imaging device 152 is positioned outside the patient's body. For example, the extraluminal imaging system 151 can control the extraluminal imaging device 152 to obtain extraluminal images of the inside of the patient's body while the extraluminal imaging device 152 is located outside the patient's body.

[0015] The physiological measurement system 101 can communicate with the extraluminal imaging system 151 via any suitable component. Such communication can be established via a cable, a wireless signal, or by any other suitable means. Additionally, the physiological measurement system 101 can be in continuous or intermittent communication with the X-ray system 151. For example, the two systems can be temporarily brought into communication at a specific time before, after, or during an examination via a cable, or via wireless communication, or by any other suitable means.Additionally, the physiological measurement system 101 can receive data such as X-ray images, annotated X-ray images, metrics calculated by the X-ray imaging system 151, information on the date and time of examinations, the type and / or severity of the patient's condition or diagnosis, the medical history or other patient information, or any other suitable data or information from the X-ray imaging system 151. The X-ray imaging system 151 can also receive any of this data from the physiological measurement system 101. In some embodiments and as shown in... Fig. As shown in Figure 1A, the physiological measurement system 101 and the X-ray imaging system 151 can communicate with the same control system 130. In this embodiment, both systems can communicate with the same display 132, processor 134, and communication interface 140, as well as with all other components implemented in the control system 130.

[0016] The intraluminal imaging system 191 can communicate with the extraluminal imaging system 151 via any suitable components. Such communication can be established via a cable, a wireless signal, or by any other suitable means. Additionally, the intraluminal imaging system 191 can be in continuous or intermittent communication with the X-ray system 151. For example, the two systems can be temporarily brought into communication at a specific time before, after, or during an examination, either via a cable, wirelessly, or by any other suitable means.Additionally, the intraluminal imaging system 191 can receive data such as radiographs, annotated radiographs, metrics calculated by the radiographic imaging system 151, information on the date and time of examinations, the type and / or severity of the patient's condition or diagnosis, the medical history or other patient information, or any other suitable data or information from the radiographic imaging system 151. The radiographic imaging system 151 can also receive any of this data from the intraluminal imaging system 191. In some embodiments and as shown in . Fig. As shown in Figure 1A, the intraluminal imaging system 191 and the X-ray imaging system 151 can communicate with the same control system 130. In this embodiment, both systems can communicate with the same display 132, processor 134, and communication interface 140, as well as with all other components implemented in the control system 130.

[0017] The intraluminal imaging system 191 can communicate with the physiological measurement system 101 via any suitable component. Such communication can be established via a cable, a wireless signal, or by any other suitable means. Additionally, the intraluminal imaging system 191 can be in continuous or intermittent communication with the physiological measurement system 101. For example, the two systems can be temporarily brought into communication at a specific time before, after, or during an examination via a cable, or via wireless communication, or by any other suitable means.Additionally, the intraluminal imaging system 191 can receive data such as pressure data, blood flow data, metrics calculated by the physiological measurement system 101, information on the date and time of examinations, the type and / or severity of the patient's condition or diagnosis, the medical history or other patient information, or any other suitable data or information from the physiological measurement system 101. The physiological measurement system 101 can also receive any of this data from the intraluminal imaging system 191. In some embodiments and as shown in . Fig. As shown in Figure 1A, the intraluminal imaging system 191 and the physiological measurement system 101 can communicate with the same control system 130. In this embodiment, both systems can communicate with the same display 132, processor 134, and communication interface 140, as well as with all other components implemented in the control system 130.

[0018] In some embodiments, the system 100 may not include a control system 130 that communicates with the physiological measurement system 101, the intraluminal imaging system 191, and / or the X-ray imaging system 151. Instead, the system 100 may include separate control systems. For example, one control system may communicate with or be part of the physiological measurement system 101, one control system may communicate with or be part of the intraluminal imaging system 191, and an additional separate control system may communicate with or be 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 may resemble the control system 130.For example, each control system can include various components or systems such as a communication interface, a processor, and / or a display. In this embodiment, each of the control systems of the physiological measurement system 101, the intraluminal imaging system 191, or the extraluminal imaging system 151 can perform some or all of the co-registration steps described in the present disclosure. In some embodiments, a control system 130 can communicate with and be configured to control 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, a control system 130 can communicate with and be configured to control the intraluminal imaging system 191 and the extraluminal imaging system 151, while a separate control system 130 controls the physiological measurement system 101.

[0019] The physiological measurement system 101 can 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 instant wave-free ratio (iFR) system, a fractional flow reserve (FFR) system, or a Pd / Pa system. The intraluminal system 101 may include a pressure guide wire, such as a solid-core pressure wire. The pressure wire may include one or more features described in U.S. Patent No. 5715827, issued on February 10, 1998, entitled "Ultra Miniature Pressure Sensor and Guide Wire Using the Same and Method", in U.S. Patent No. 8277386, issued on October 2, 2012, entitled "Combination Sensor Guidewire and Methods of Use", and in U.S. Patent No. 9339348, issued on May 17, 2016, entitled "Devices, Systems, and Methods for Assessing a Vessel", which are hereby incorporated in their entirety by reference.

[0020] At a higher level, a pressure sensing device can be positioned within a patient's body lumen. The pressure sensing device can include a pressure-sensitive guidewire 107 and a pressure sensor catheter 103. The pressure guidewire 107 can include a pressure sensor. The pressure sensor catheter can also include a pressure sensor. During a pressure pullback procedure, the pressure sensor catheter 103 can be positioned within the vessel at a location proximal to the region to be measured. The sensor of the pressure-sensitive guidewire 107 can also be positioned within the vessel at a location distal to the region to be measured. The pressure sensor catheter 103 can remain essentially stationary during the pullback procedure. Subsequently, the pressure guidewire 107 is pulled back, so that the sensor moves from the distal position through the vessel in a proximal direction.As the distal guidewire sensor moves through the lumen, both the guidewire sensor 107 and the catheter sensor 103 acquire pressure measurements. Thus, for each position of the guidewire 107, two pressure measurements can be acquired: a distal guidewire pressure and a proximal catheter pressure. These two pressures can then be compared to generate a pressure ratio. The pressure ratio can be a fractional flow reserve (FFR), an instantaneous wave-free ratio (iFR), Pd / Pa, and / or any other suitable pressure ratio. For example, if the two sensors are located at substantially the same location in the vessel (e.g., after a pressure pullback procedure has been completed), the pressures recorded by each sensor will be equal or substantially equal. The resulting pressure ratio of these two pressures can therefore be 1.0 or close to 1.0.If the withdrawal point is distal to a blockage in 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. The degree to which this pressure ratio is less than 1.0 indicates the severity of the blockage. As the distal guidewire sensor is moved proximal along the guidewire from its starting point (distal to the vessel), the pressure measured by the distal guidewire sensor relative to the proximal, stationary catheter sensor can vary. Therefore, as the distal guidewire sensor moves, the ratio may begin to increase, approaching 1.0 at different points along the analyzed vessel as the distal guidewire pressure sensor approaches the proximal catheter sensor.

[0021] The communication interface 140 facilitates the communication of measurements between the control system 130 and the physiological measurement system 101. In some embodiments, the communication interface 140 performs preliminary data processing before forwarding the data to the processor 134. In one embodiment, the communication interface 140 also provides high- and low-voltage direct current to support the operation of the devices of the physiological measurement system 101.

[0022] The patient interface module PIM 104 can be configured to further facilitate communication between the physiological measurement system 101 and the control system 130. For example, the PIM 104 can electrically couple a transmission cable bundle to the communication interface 140 and physically couple any pressure sensing device, including the pressure sensor guidewire 107 and / or the pressure sensor catheter 103, to the communication interface 140. In some embodiments, the communication interface 140 can be a PIM.

[0023] The hemodynamic system 105 can include various features of the physiological measurement system 101. For example, the hemodynamic system 105 can include a communication interface that facilitates communication between the pressure sensor catheter 103 and the control system 130. In some embodiments, the hemodynamic system 105 can communicate with additional elements of the physiological measurement system 101, such as the pressure-sensitive guidewire 107 or any other systems or devices. For example, the hemodynamic system can communicate with an extraluminal imaging system, such as the extraluminal imaging system 151. The hemodynamic system 105 can communicate with electrocardiogram (ECG) electrodes and provide a graphical display of the patient's heart electrocardiogram. The hemodynamic system 105 can communicate with a heart rate sensor and provide a graphical display of the heart rate.The hemodynamic system 105 can communicate with an external blood pressure monitoring device (e.g., a blood pressure monitor, an inflatable cuff and / or a manometer) and provide a graphical display of the systolic and diastolic blood pressure.

[0024] In some embodiments, the intraluminal device is a pressure sensing device (e.g., a pressure-sensitive guidewire) that receives intraluminal (e.g., intravascular) pressure data, and the physiological measurement system 101 is an intravascular pressure sensing system that determines pressure ratios based on the pressure data, such as the fractional flow reserve (FFR), the instantaneous wave-free ratio (iFR), and / or another suitable ratio between distal pressure and proximal / aortic pressure (Pd / Pa). In some embodiments, the intraluminal device is a flow sensing device (e.g., a pressure-sensitive guidewire) that receives intraluminal (e.g., intravascular) flow data, and the intraluminal system 101 is an intravascular flow sensing system that determines flow-related values ​​based on the pressure data, such as the coronary flow reserve (CFR), flow velocity, flow volume, etc.

[0025] Fig. Figure 1B is a schematic diagram of an extraluminal imaging system according to the aspects of this disclosure. The X-ray imaging system 151 may include an X-ray imaging device or apparatus 152 configured to perform X-ray imaging, angiography, fluoroscopy, radiography, venography, and other imaging techniques. The X-ray imaging system 151 may generate a single X-ray image (e.g., an angiogram or venogram) or multiple (e.g., two or more) X-ray images (e.g., a video and / or fluoroscopy image stream) based on the X-ray image data collected by the X-ray device 152. The X-ray imaging device 152 may be of any suitable type; for example, it may be a stationary X-ray system such as a fixed-arm 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 can additionally be any suitable mobile device. The X-ray imaging device 152 can also communicate with the control system 130. In some embodiments, the X-ray system 151 can include a digital X-ray device or another suitable device.

[0026] The in Fig. The X-ray device 152 shown in Figure 1B includes an X-ray source 160 and an X-ray detector 170 with an input screen 174. The X-ray source 160 and the detector 170 can be mounted at a distance from each other. An anatomical model of a patient or object 180 can be positioned between the X-ray source 160 and the X-ray detector 170. For example, the anatomical model of the patient (including the vessel 120) can be positioned between the X-ray source 160 and the X-ray detector 170.

[0027] The X-ray source 160 may include an X-ray tube suitable for generating X-rays. Some aspects of the X-ray source 160 may include one or more vacuum tubes, including a cathode connected to the negative terminal of a high-voltage power source and an anode connected to the positive terminal of the same power source. The cathode of the X-ray source 160 may additionally include a filament. The filament may be of any suitable type or made of any suitable material, including tungsten or rhenium tungsten, and may be positioned in a recessed region of the cathode. One function of the cathode may be to eject electrons from the high-voltage power source and focus them into a precisely defined beam directed toward the anode.The anode can also be constructed from any suitable material and configured to generate X-rays from the electrons emitted by the cathode. Additionally, the anode can dissipate the heat generated during X-ray production. The anode can be in the form of a beveled disk and, in some embodiments, rotated by an electric motor. The cathode and anode of the X-ray source 160 can be housed in an airtight enclosure, sometimes referred to as a shell.

[0028] In some embodiments, the X-ray source 160 can include a radiation object focus that affects the visibility of an image. The radiation object focus can be selected by a user of the system 100 or by a manufacturer of the system 100 based on properties such as blurriness, visibility, heat dissipation capacity, or other characteristics. In some embodiments, an operator or user of the system 100 can switch between differently provided radiation object foci in a point-of-care environment.

[0029] The detector 170 can be configured to acquire X-ray images and can include the input screen 174. The input screen 174 can include one or more intensifier screens configured to absorb X-ray energy and convert it into light. This light can then expose a film. In embodiments where the film is more photosensitive than X-rays, the input screen 174 can be used to convert X-ray energy into light. Depending on the patient region to be imaged, image detail requirements, and / or patient irradiation, or other factors, different types of intensifier screens can be selected in the image intensifier. Intensifier screens can be constructed from any suitable material, including barium strontium sulfate, barium fluorochloride, yttrium oxysulfide, or any other suitable material.The input screen 174 can be a fluorescent screen or a film positioned directly adjacent to a fluorescent screen. In some embodiments, the input screen 174 can also include a protective screen to shield switching logic or components within the detector 170 from the environment. In some embodiments, the X-ray detector 170 can include a flat-panel detector (FPD). The detector 170 can be an indirect-conversion or direct-conversion FPD. The detector 170 can also include charge-coupled devices (CCDs). The X-ray detector 170 can additionally be referred to as an X-ray sensor.

[0030] Object 180 can be any suitable object to be depicted. In one exemplary embodiment, the object can be the anatomy of a patient. More specifically, the anatomy to be depicted can include the thorax, abdomen, pelvis, neck, legs, head, feet, an area containing the heart vessels, or an area containing the peripheral vessels of a patient, and can include various anatomical structures such as, but not limited to, organs, tissues, blood vessels and blood, gases, or any other anatomical structures or objects. In other embodiments, the object can be or contain man-made structures.

[0031] In some embodiments, the X-ray imaging system 151 can be configured to obtain X-ray images without contrast. In other embodiments, the X-ray imaging system 151 can be configured to obtain X-ray images with contrast (e.g., angiogram or venogram). In such embodiments, a contrast agent or X-ray dye can be introduced into the patient's anatomy prior to imaging. The contrast agent can also be referred to as an X-ray contrast medium, contrast material, contrast dye, or contrast medium. The contrast agent can be made of any suitable material, chemical, or compound and can be in the form of a liquid, powder, paste, tablet, or other suitable form. For example, the contrast dye can be iodine-based compounds, barium sulfate compounds, gadolinium compounds, or other suitable compounds.The contrast agent can be used to improve the visibility of internal fluids or structures in a patient's anatomy. The contrast agent can absorb external X-rays, resulting in reduced exposure at the X-ray detector 170.

[0032] In some embodiments, the extraluminal imaging system 151 could be any suitable extraluminal imaging device, such as a computed tomography (CT) scanner or a magnetic resonance imaging (MRI) scanner.

[0033] When the control system 130 communicates 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 the 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 data before forwarding this X-ray data to the processor 134. In examples of such embodiments, the communication interface 140 may perform amplification, filtering, and / or aggregation of the data. In one embodiment, the communication interface 140 also provides high- and low-voltage direct current to support the operation of the device 152, including the switching logic within the device.

[0034] The processor 134 receives the X-ray data from the X-ray device 152 via the communication interface 140 and processes the data to reconstruct an image of the imaged anatomy. The processor 134 outputs image data so that an image is displayed on the display 132. In an embodiment in which the contrast medium is introduced into a patient's anatomy and a venogram is to be generated, the areas of interest to be imaged can be one or more blood vessels or another section or part of the human vascular system. The contrast medium can identify fluid-filled structures, both natural and artificial, such as arteries or veins of a patient's vascular system, including cardiac vessels, peripheral vessels, nerve vessels, renal vessels, and / or any other suitable lumen in the body.For example, the X-ray device 152 can be used to examine any number of anatomical locations and tissue types, including, but not limited to, all previously mentioned organs, fluids, or other structures or parts of anatomy. In addition to natural structures, the X-ray device 152 can also be used to examine artificial structures such as all previously mentioned structures.

[0035] The processor 134 can be configured to receive an X-ray image captured by the X-ray imaging device 152 during a clinical procedure. The images can be further enhanced by additional information such as patient history, medical records, IVUS imaging, preoperative ultrasound imaging, preoperative CT, or other suitable data.

[0036] Fig. Figure 1C is a schematic diagram of an intraluminal imaging device 102 according to the aspects of the present disclosure. Fig. Figure 1C illustrates aspects of the intraluminal imaging system 191, including an intraluminal imaging device 102 and associated components. As described above, the intraluminal imaging system 191 can be integrated into various systems of the larger system 100. Furthermore, the intraluminal imaging system 191 can incorporate additional components beyond those shown in Figure 1C. Fig. 1C included. In some implementations, the intraluminal imaging device 102 may be a catheter or a guidewire.

[0037] The intraluminal imaging system 191 can be an ultrasound imaging system. In some cases, the intraluminal imaging system 191 can be an intravascular ultrasound (IVUS) imaging system. The intraluminal imaging system 191 can include an intraluminal imaging device 102, such as a catheter, guidewire, or guide catheter, which communicates with the control system 130. The control system 130 can include a display 132, a processor 134, a communication interface 140, among other components. The intraluminal imaging device 102 can be an ultrasound imaging device. In some cases, the device 102 can be an IVUS imaging device, such as a solid-state IVUS device.

[0038] At a high level, the IVUS device 102 emits ultrasound energy from a transducer array 124, which is contained within a scanner assembly, also referred to as an IVUS imaging assembly, and is mounted near a distal end of the catheter device. The ultrasound energy is reflected by tissue structures in the surrounding medium, such as a vessel 120 or other body lumen surrounding the scanner assembly 110, and the ultrasound echo signals are received by the transducer array 124. In this respect, the device 102 can be sized, shaped, or otherwise configured to be positioned within a patient's body lumen. The communication interface 140 transmits the received echo signals to the processor 134 of the control system 130, where the ultrasound image (in some embodiments including flow information) is reconstructed and displayed on the display 132.The control system 130, including the processor 134, can be operated to facilitate the features of the IVUS imaging system 191 described herein. For example, the processor 134 can execute computer-readable instructions stored on the transitory, tangible, computer-readable medium.

[0039] The communication interface 140 facilitates signal communication between the control system 130 and the scanner assembly 110 contained in the IVUS device 102. This communication includes the following steps: (1) providing commands to the integrated circuit control dies contained in the scanner assembly 110 to select the specific transducer array elements or acoustic elements to be used for transmitting and receiving, (2) providing the transmit trigger signals to the integrated circuit control chips contained in the scanner assembly 110 to activate the transmit switching logic and generate an electrical pulse to excite the selected transducer array elements, and / or (3) receiving amplified echo signals received by the selected transducer array elements via amplifiers contained on the integrated circuit control chips of the scanner assembly 110.In some embodiments, the communication interface 140 performs preliminary processing of the data before forwarding this echo 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- and low-voltage direct current to support the operation of the device 102, including the switching logic within the scanner arrangement 110.

[0040] The processor 134 receives the echo data from the scanner assembly 110 via the communication interface 140 and processes the data to reconstruct an image of the tissue structures in 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 the vessel 120, is displayed on the display 132. The lumen 120 can represent fluid-filled or fluid-surrounded structures, both natural and artificial. The lumen 120 can be located inside a patient's body. The lumen 120 can be a blood vessel, such as an artery or vein of a patient's vascular system, including the cardiovascular system, peripheral vascular system, neural vascular system, renal vascular system, and / or any other suitable lumen inside the body.For example, the Device 102 can be used to examine any number of anatomical locations and tissue types, including, without limitation, organs such as the liver, heart, kidneys, gallbladder, pancreas, and lungs; ducts; intestines; nervous system structures, including the brain, dural sac, spinal cord, and peripheral nerves; the hamstring tract; as well as valves within the blood, chambers, or other parts of the heart and / or other systems of the body. In addition to natural structures, the Device 102 can be used to examine artificial structures, such as, but without limitation, heart valves, stents, shunts, filters, implants, and other devices.

[0041] In some embodiments, the IVUS device incorporates features similar to those of conventional solid-state IVUS catheters, such as the EagleEye® catheter, the Visions PV .014P RX catheter, the Visions PV .018 catheter, the Visions PV .035 catheter, and the Pioneer Plus catheter, all of which are available from Koninklijke Philips NV and disclosed in U.S. Patent No. 7,846,191, to which reference is hereby made in its entirety. For example, the IVUS device 102 incorporates the scanner assembly 110 near a distal end of the device 102 and a transmission cable bundle 112 extending along the longitudinal body of the device 102. The transmission cable bundle or cable 112 may include a plurality of conductors, including one, two, three, four, five, six, seven, or more. It goes without saying that any measuring wire diameter can be used for the conductors.In one embodiment, the cable 112 can include a four-core transmission line configuration with, for example, 41 AWG gauge measuring wires. In another embodiment, the cable 112 can include a seven-core transmission line configuration using, for example, 44 AWG gauge measuring wires. In some embodiments, 43 AWG gauge measuring wires can be used.

[0042] The transmission cable bundle 112 terminates in a patient interface module (PIM) connector 114 at a proximal end of the device 102. The PIM connector 114 electrically couples the transmission cable bundle 112 to the communication interface 140 and physically couples the IVUS device 102 to the communication interface 140. In some embodiments, the communication interface 140 may be a PIM. In one embodiment, the IVUS device 102 further includes a guidewire connector 116. Accordingly, in some cases, the IVUS device 102 is a quick-change catheter. The guidewire connector 116 allows the insertion of a guidewire 118 toward the distal end to guide the device 102 through the vessel 120.

[0043] In some embodiments, the intraluminal imaging device 102 can acquire intravascular images using any suitable imaging modality, including optical coherence tomography (OCT) and intravascular photoacoustics (IVPA).

[0044] Fig. Figure 2 is a diagrammatic top view of an ultrasound imaging arrangement in a flat configuration according to aspects of the present disclosure. The flexible arrangement 110 includes a transducer array 124 formed in a transducer region 204, and transducer control logic dies 206 (including dies 206A and 206B) formed in a control region 208, with the transition region 210 located between them. The transducer array 124 includes an array of ultrasound transducer elements 212. The transducer control logic dies 206 are mounted on a flexible substrate 214 into which the transducer elements 212 have been previously integrated. The flexible substrate 214 is in Fig. 2 shown in a flat configuration. Although in Fig. Since six control logic dies 206 are shown, 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.

[0045] The flexible substrate 214, on which the converter control logic dies 206 and the converter elements 212 are mounted, provides structural support and intermediate connections for electrical coupling. The flexible substrate 214 can be designed to include a film layer of a flexible polyimide material such as KAPTON™ (registered trademark of DuPont). Other suitable materials include polyester films, polyimide films, polyethylene naphthalate films or polyetherimide films, liquid crystal polymers, other flexible printed semiconductor substrates, and products such as Upilex® (registered trademark of Ube Industries) and TEFLON® (registered trademark of E.I. duPont). In the Fig. In the flat configuration illustrated in Figure 2, the flexible substrate 214 generally has a rectangular shape. As shown and described herein, the flexible substrate 214 is configured in some cases to be supported by a support element 230 ( Fig. 3) to be wound. Therefore, the thickness of the film layer of the flexible substrate 214 generally depends on the degree of curvature of the finally assembled flexible arrangement 110. In some embodiments, the film layer is between 5 µm and 100 µm, in some special embodiments between 5 µm and 25.1 µm, e.g. 6 µm.

[0046] The set of converter-control logic dies 206 is a non-restrictive example of a control circuit. The converter region 204 is arranged on a distal section 221 of the flexible substrate 214. The control region 208 is arranged on a proximal section 222 of the flexible substrate 214. The transition region 210 is arranged between the control region 208 and the converter region 204. The dimensions of the converter region 204, the control region 208, and the transition region 210 (e.g., lengths 225, 227, 229) can vary in different embodiments. In some embodiments, the lengths 225, 227 and 229 may be substantially similar, or the length 227 of the transition region 210 may be smaller than the lengths 225 and 229, the length 227 of the transition region 210 may be larger than the lengths 225 and 229 of the converter region and the control region, respectively.

[0047] 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 contains the communication interface for cable 112 between a processing system, e.g., processing system 134, and the flexible arrangement 110. Accordingly, the master control circuit may include control logic that decodes control signals received over cable 112, transmits control responses over cable 112, amplifies echo signals, and / or transmits the echo signals over cable 112. The remaining controllers are slave controllers 206B. The slave controllers 206B may include control logic that drives a plurality of transducer elements 512 positioned on a transducer element 212 to emit an ultrasonic signal and selects a transducer element 212 to receive an echo.In the illustrated embodiment, the master controller 206A does not directly control the converter elements 212. In other embodiments, the master controller 206A controls the same number of converter elements 212 as the slave controllers 206B, or controls a reduced number of converter elements 212 compared to the slave controllers 206B. In one embodiment, a single master controller 206A and eight slave controllers 206B are provided, with each slave controller 206B being assigned eight converters.

[0048] To electrically connect the control logic dies 206 and the transducer elements 212, the flexible substrate 214, in one embodiment, incorporates conductive traces 216 formed in the film layer, which carry signals between the control logic dies 206 and the transducer elements 212. Specifically, the conductive traces 216, which provide communication between the control logic dies 206 and the transducer elements 212, extend along the flexible substrate 214 within the transition region 210. In some cases, the conductive traces 216 can also facilitate electrical communication between the master controller 206A and the slave controllers 206B. The conductive traces 216 can also provide a set of conductive pads that contact the conductors 218 of the cable 112 when the conductors 218 of the cable 112 are mechanically and electrically coupled to the flexible substrate 214.Suitable materials for the conductive tracks 216 include, for example, copper, gold, aluminum, silver, tantalum, nickel, and tin, and they can be deposited onto the flexible substrate 214 by processes such as sputtering, plating, and etching. In one embodiment, the flexible substrate 214 incorporates a chromium adhesion layer. The width and thickness of the conductive tracks 216 are selected to provide suitable conductivity and elasticity when the flexible substrate 214 is wound. In this respect, an exemplary range for the thickness of a conductive track 216 and / or a conductive pad is between 1 and 5 µm. In one embodiment, for example, the 5 µm conductive tracks 216 are separated from each other by a spacing of 5 µm. The width of a conductive track 216 on the flexible substrate can also be determined by the width of the conductor 218 that is to be coupled to the track or pad.

[0049] In some embodiments, the flexible substrate 214 may include a conductor interface 220. The conductor interface 220 may be located at a point on the flexible substrate 214 where the conductors 218 of the cable 112 are coupled to the flexible substrate 214. For example, the bare conductors of the cable 112 are electrically coupled to the flexible substrate 214 at the conductor interface 220. The conductor interface 220 may be a tab extending from the main body of the flexible substrate 214. In this respect, the main body of the flexible substrate 214 may collectively refer to the transducer region 204, the control region 208, and the transition region 210. In the illustrated embodiment, the conductor interface 220 extends from the proximal section 222 of the flexible substrate 214.In other embodiments, the conductor interface 220 is positioned on other parts of the flexible substrate 214, such as the distal section 221, or the conductor interface 220 may be absent from the flexible substrate 214. A dimension of the tab or conductor interface 220, such as a width 224, may be smaller than a dimension of the main body of the flexible substrate 214, such as a width 226. In some embodiments, the substrate forming the conductor interface 220 is made of the same material(s) and / or is similarly flexible to the flexible substrate 214. In other embodiments, the conductor interface 220 is made of different materials and / or is comparatively stiffer than the flexible substrate 214. For example, the conductor interface 220 may be made of plastic, thermoplastic, polymer, hard polymer, etc., including polyoxymethylene (e.g., tungsten carbide).DELRIN®), polyetheretherketone (PEEK), nylon, liquid crystal polymer (LCP) and / or other suitable materials.

[0050] Fig. Figure 3 is a diagrammatic perspective view of the ultrasound imaging setup in a configuration rolled around a support element according to the aspects of the present disclosure. Fig. Figure 3 illustrates a perspective view of the scanner arrangement 110 in a rolled configuration. In some cases, the flexible substrate 214 is replaced by a flat configuration ( Fig. 2) into a rolled or more cylindrical configuration ( Fig. 3) transferred. For example, some embodiments utilize techniques disclosed in one or more of U.S. Patent Nos. 6,776,763 entitled “ULTRASONIC TRANSDUCER ARRAY AND METHOD OF MANUFACTURING THE SAME” and U.S. Patent Nos. 7,226,417 entitled “HIGH RESOLUTION INTRAVASCULAR ULTRASOUND SENSING ASSEMBLY HAVING A FLEXIBLE SUBSTRATE”, which are hereby incorporated herein in their entirety by reference.

[0051] Depending on the application and embodiment of the present invention, the transducer elements 212 can be piezoelectric transducers, single-crystal transducers, or PZT (lead zirconate titanate) transducers. In other embodiments, the transducer elements of the transducer array 124 can be bending transducers, piezoelectric micromechanical ultrasonic transducers (PMUTs), capacitive micromechanical ultrasonic transducers (CMUTs), or any other suitable type of transducer element. In such embodiments, the transducer elements 212 can comprise an elongated semiconductor material or another suitable material that allows micromachining or similar methods for arranging extremely small elements or switching logic on a substrate.

[0052] In some embodiments, the transducer elements 212 and the controllers 206 can be positioned in an annular configuration, such as a circular configuration, or in a polygonal configuration around a longitudinal axis 250 of a support element 230. It is understood that the longitudinal axis 250 of the support element 230 can also be referred to as the longitudinal axis of the scanner arrangement 110, the flexible elongated element 121, or the device 102. For example, a cross-sectional profile of the imaging arrangement 110 at the transducer elements 212 and / or the controllers 206 can be a circle or a polygon. Any suitable annular polygon shape can be implemented, such as one based on the number of controllers or transducers, the flexibility of the controllers or transducers, etc. Some examples of such shapes are pentagon, hexagon, heptagon, octagon, nonagon, decagon, etc.In some examples, the transducer controllers 206 can be used to control the ultrasonic transducers 512 of the transducer elements 212 to obtain imaging data associated with the vessel 120.

[0053] The support element 230 may in some cases be referred to as a unibody. The support element 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. Preliminary Application No. 61 / 985,220 “Pre-Doped Solid Substrate for Intravascular Devices” dated April 28, 2014, the contents of which are hereby incorporated in full by reference. In some embodiments, the support element 230 may be composed of stainless steel 303. The support element 230 may be a clamp with a distal flange or section 232 and a proximal flange or section 234. The support element 230 may have a tubular shape and define a lumen 236 extending longitudinally therethrough it. The lumen 236 may be dimensioned and shaped to accommodate the guide wire 118. The support element 230 can be manufactured using any suitable method.For example, the support element 230 can be machined by subtractive and / or electrochemical processes or laser milling, such as by removing material from a blank to form the support element 230, or cast, such as by an injection molding process or a micro injection molding process.

[0054] Fig. Figure 4 is a diagrammatic cross-sectional side view of the ultrasound imaging arrangement according to the aspects of the present disclosure. The intraluminal imaging device 102 can, according to the aspects of the present disclosure, include the flexible substrate 214 and the support element 230. The lumen 236 can be connected to the inlet / outlet port 116 and is dimensioned and shaped to accommodate the guide wire 118 ( Fig. 1C). In some embodiments, the support element 230 can be formed in one piece as a single structure, while in other embodiments the support element 230 can be formed from different components, such as a clamp and the stands 242, 243, and 244, which are rigidly coupled to one another. In some cases, the support element 230 and / or one or more of its components can be completely integrated into the inner element 256. In some cases, the inner element 256 and the support element 230 can be joined together to form a single unit, e.g., in the case of a polymer support element.

[0055] Vertically extending supports 242, 243, and 244 are provided at the distal, middle, and proximal sections of the support element 230. The supports 242, 243, and 244 lift and support the distal, middle, and proximal sections of the flexible substrate 214. In this respect, sections of the flexible substrate 214, such as the transducer section 204 (or transducer region 204), can be spaced apart from a middle body section of the support element 230, which extends between the supports 242, 243, and 244. The supports 242, 243, and 244 can have the same outer diameter or different outer diameters. For example, the distal stand 242 may have a larger or smaller outer diameter than the middle stand 243 and / or the proximal stand 244 and may also have special features for rotational alignment as well as the placement and connection of the control chip.

[0056] To improve acoustic performance, the cavity between the transducer array 212 and the surface of the support element 230 can be filled with an acoustic carrier material 246. The liquid carrier material 246 can be introduced between the flexible substrate 214 and the support element 230 via the passage 235 in the stand 242 or through additional recesses, as discussed in more detail below. The carrier material 246 can serve to dampen the ultrasonic energy emitted by the transducer array 212 that propagates in the undesired, inward direction.

[0057] The cavity between the circuit control chips 206 and the surface of the support element 230 can be filled with a filler material 247. The filler material 247 can be an adhesive (e.g., an epoxy resin) that provides structural support to the circuit control chips 206 and / or the flexible substrate 214. The filler material 247 can also be made of any suitable material.

[0058] In some embodiments, the central body section of the support element can include recesses that allow fluid communication between the lumen of the unibody and the cavities between the flexible substrate 214 and the support element 230. Acoustic carrier material 246 and / or backer rod 247 can be introduced through the cavities (during an assembly process, before the inner element 256 extends through the lumen of the unibody). In some embodiments, suction can be applied through the passages 235 of one of the supports 242, 244, or through another suitable recess, while the liquid carrier material 246 is introduced between the flexible substrate 214 and the support element 230 through the passages 235 of the other support 242, 244, or through another suitable recess. The carrier material can be cured to solidify and harden.In various embodiments, the support element 230 includes more than three stands 242, 243, and 244, only one or two of the stands 242, 243, 244, or none of the stands. In this respect, the support element 230 can have a distal section 262 with an increased diameter and / or a proximal section 264 with an increased diameter, which is dimensioned and shaped to lift and support the distal and / or proximal sections of the flexible substrate 214.

[0059] The support element 230 can be essentially cylindrical in some embodiments. Other shapes of the support element 230 are also conceivable, including geometric, non-geometric, symmetrical, and asymmetrical cross-sectional profiles. As the term used herein, the shape of the support element 230 can refer to a cross-sectional profile of the support element 230. Different sections of the support element 230 can be shaped differently in other embodiments. For example, the proximal section 264 can have a larger outer diameter than the distal section 262, or a middle section extending between the distal and proximal sections 262, 264. In some embodiments, an inner diameter of the support element 230 (e.g., the diameter of the lumen 236) can increase or decrease accordingly as the outer diameter changes.In other embodiments, the inner diameter of the support element 230 remains the same despite variations in the outer diameter.

[0060] A proximal inner element 256 and a proximal outer element 254 are coupled to the proximal section 264 of the support element 230. The proximal inner element 256 and / or the proximal outer element 254 can comprise a flexible elongated element. The proximal inner element 256 can be accommodated in a proximal flange 234. The proximal outer element 254 abuts and is in contact with the proximal end of the flexible substrate 214. A distal tip element 252 is coupled to the distal section 262 of the support element 230. For example, the distal element 252 is positioned around the distal flange 232. The tip element 252 can abut and be in contact with the distal end of the flexible substrate 214 and the stand 242. In other embodiments, the proximal end of the tip element 252 in its rolled configuration can be received in the distal end of the flexible substrate 214.In some embodiments, a gap may exist between the flexible substrate 214 and the tip element 252. The distal element 252 may be the most distal component of the intraluminal imaging device 102. The distal tip element 252 may be a flexible polymer component that defines the most distal end of the imaging device 102. The distal tip element 252 may additionally define a lumen that communicates with the lumen 236 defined by the support element 230. The guide wire 118 may extend through the lumen 236 as well as the lumen defined by the tip element 252.

[0061] One or more adhesives can be arranged between different components on the distal section of the intraluminal imaging device 102. For example, one or more of the flexible substrate 214, the support element 230, the distal element 252, the proximal inner element 256, the transducer array 212, and / or the proximal outer element 254 can be coupled to one another via an adhesive. In other words, the adhesive can be in contact with, for example, the transducer array 212, the flexible substrate 214, the support element 230, the distal element 252, the proximal inner element 256, and / or the proximal outer element 254, as well as other components.

[0062] Fig. Figure 5 is a schematic diagram of a processor circuit according to the aspects of the present disclosure. The processor circuit 510 can be used in the control system 130 of Fig. 1A, in the intraluminal imaging system 191, in the physiological measurement system 101 and / or in the X-ray imaging system 151, or at any other suitable location. For example, the processor circuit 510 can communicate with the intraluminal imaging device 102, the X-ray imaging device 152, the pressure-sensitive guidewire and / or catheter described above, and / or the display 132 within the system 100. The processor circuit 510 can communicate with the processor 134 and / or the communication interface 140 ( Fig. 1A) include. One or more processor circuits 510 are configured to perform the operations described herein. As shown, the processor circuit 510 can include a processor 560, a memory 564, and a communication module 568. These elements can communicate with each other directly or indirectly, for example, via one or more buses.

[0063] The Processor 560 can include a CPU, a GPU, a DSP, an application-specific integrated circuit (ASIC), a controller, an FPGA, another hardware device, a firmware device, or any combination thereof, configured to perform the operations described herein. The Processor 560 can also be implemented as a combination of computing devices, such as a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[0064] The memory 564 can include a cache memory (e.g., a cache memory of the processor 560), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read-only memory (EPROM), electrically erasable programmable read-only memory (EEPROM), flash memory, a solid-state storage device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different memory types. In one embodiment, the memory 564 includes a non-transient, computer-readable medium. The memory 564 can store instructions 566. The instructions 566 can include instructions which, when executed by the processor 560, cause the processor 560 to perform the following actions with reference to the probe 110 and / or the host 130 ( Fig. 1) to carry out the described operations. The instructions 566 may also be referred to as code. The terms "instructions" and "code" are to be interpreted broadly and include any type of computer-readable instruction. The terms "instructions" and "code" may, for example, refer to one or more programs, routines, subroutines, functions, processes, etc. "Instructions" and "code" may include a single computer-readable instruction or many computer-readable instructions.

[0065] The communication module 568 can incorporate any electronic circuitry and / or logic circuitry to support direct or indirect data communication between the processor circuit 510, the probe 110, and / or the display 132. In this respect, the communication module 568 can be an input / output (I / O) device. In some instances, the communication module 568 supports direct or indirect communication between different elements of the processor circuit 510 and / or the probe 110 ( Fig. 1C) and / or the host 130 ( Fig. 1A).

[0066] Fig. Figure 6 is a diagrammatic view of region 600 of a patient's vascular system according to the aspects of the present disclosure. In Fig. Figure 6 shows a view of a vessel 690 that was measured using the physiological measurement system 101 and the intraluminal imaging system 191. A physiological measurement procedure can be completed before or after an intraluminal imaging procedure.

[0067] In one example, a physiological measurement method can be performed. During this procedure, a pressure sensing device of the physiological measurement system 101 can be positioned in vessel 690. For example, the pressure sensor catheter can be positioned at a point 611 within vessel 690. The distal pressure sensor of the pressure-sensitive guidewire can be positioned at a starting point 610, as shown by point 602. During the pressure sensing procedure, the distal pressure sensor of the pressure-sensitive guidewire can be moved from point 610 to point 611 within vessel 690. As the guidewire is moved from position 610 to position 611, the distal sensor can acquire pressure measurements. The proximal pressure sensor of the stationary catheter at point 611 can also acquire pressure measurements.For each point along vessel 690 through which the distal sensor of the guide wire passes, a pressure ratio can be calculated and assigned to that point along vessel 690, as with reference to . Fig. 7 is described.

[0068] In Fig. Figure 6 shows a passage path 603 next to vessel 690. The passage path 603 can illustrate the shape and length of the path of the distal pressure sensor of the guidewire through the retraction, except that the distal pressure sensor of the guidewire has passed through vessel 690 and not alongside the lumen. This passage path 603 can be positioned within vessel 690 or at any other location.

[0069] An intraluminal imaging procedure can also be performed, for example with an intravascular ultrasound (IVUS) system, which includes an IVUS imaging device or IVUS catheter, such as the device 102 ( Fig. 1C). During this procedure, the IVUS imaging device 102 of the intraluminal imaging system 191 can be positioned in vessel 690. For example, the device 102 can be positioned at a location 612 within vessel 690. This location can be a starting position for the device 102, as shown by point 604. During the intraluminal imaging procedure, the device 102 can be moved from location 612 to location 613 within vessel 690. When the intraluminal imaging device 102 is moved from location 612 to location 613, the device 102 can acquire intraluminal ultrasound data. The intraluminal ultrasound data acquired at a specific position along the path 605 traveled by the intraluminal imaging device 102 can be received by the control system 130 and used to generate a radial cross-sectional image (e.g. an IVUS image) of the vessel 690 at that location.For each point along the vessel 690 through which the device 102 has passed, an IVUS image can be generated and assigned to that point along the vessel 690, as with reference to . Fig. 8 is described.

[0070] Passage 605 is in Fig. Figure 6 shows the passage path next to the vessel 690. The passage path 605 can illustrate the shape and length of the path of the intraluminal imaging device 102 of the intraluminal imaging system 191 through retraction, except that the device 102 passed through the vessel 690 and not next to the lumen. This passage path 605 can be positioned within the vessel 690 or at any other location.

[0071] As in Fig. 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) may not be the same. For example, position 612, which corresponds to the starting position of the IVUS imaging device 102, may be located distally (as shown in Figure 6). Fig. 6 shown) or proximal to the starting position of the pressure-sensitive guidewire. Similarly, the endpoint of the pressure guidewire (e.g., position 611) may be located at a different location than the endpoint of the device 102 (e.g., position 613). Consequently, there may be regions of vessel 690 that are imaged either only by the imaging device 102 (e.g., region 614 in the Fig. 6 example shown) or were measured only from the pressure-sensitive guide wire (e.g. region 615 in the Fig. 6 (example shown).

[0072] In some embodiments, the starting point of the pressure sensor of the guide wire and the starting point of the intraluminal imaging device 102 can be the same position. Similarly, the endpoint of the pressure guide wire can be located at the same position as the endpoint of the device 102. Consequently, all regions of the vessel 690 imaged by the imaging device 102 can also have been measured by the pressure-sensitive guide wire.

[0073] With reference to Fig. 7 and Fig. Section 8 discloses aspects of co-registering pressure data and intravascular images with an extraluminal image (e.g., an angiogram). In some embodiments, the system first uses physiological co-registration with an angiogram to establish the length of the physiological pullback. The system then registers an IVUS pullback within the same angiogram, thus establishing its length. The system then uses the lengths of these pullbacks, along with their starting points, to co-register the physiological data in a calibrated longitudinal cross-section of the IVUS pullback. In some embodiments, the registration of physiological data, intravascular data, and an angiogram may be referred to as tri-registration. In some embodiments, tri-registration may refer to the correlation of three separate imaging modalities. Each of these modalities can be displayed simultaneously.

[0074] Fig. Figure 7 is a diagrammatic view of a relationship between X-ray fluoroscopy images 710, pressure data 730 and a path 740 defined by the movement of an intravascular device according to the aspects of the present disclosure. Fig. 7 describes a method for co-registering physiological data 730, including pressure ratio data or iFR measurements, with corresponding locations on one or more fluoroscopic images 710 of the same region of a patient's anatomy.

[0075] Various aspects of co-registration of physiological data with an extraluminal image may include one or more features described in US Patent Publication No. 2006 / 0241465 of January 11, 2006, entitled “Vascular Image Co-registration”, which is hereby incorporated by reference in its entirety.

[0076] The patient's anatomy can be imaged with an X-ray device while a physician performs a pullback using a pressure-sensitive device, for example, as the pressure-sensitive guidewire moves through a blood vessel of the anatomy. The pressure-sensitive guidewire can essentially be compared to the one described in relation to... Fig. The pressure-sensitive guide wire described in 1A is similar. The X-ray device used to obtain the fluoroscopic images 710 can be essentially the same as the X-ray device 152 of Fig. 1B. In some embodiments, the fluoroscopic images 710 can be obtained without the presence of contrast medium in the patient's vascular system. Such an embodiment is described by the fluoroscopic images 710 in Fig. Figure 7 shows that in other embodiments, a contrast medium is present in the patient's vascular system. In this respect, the fluoroscopic images 810 can alternatively be angiogram images or any suitable type of extraluminal image. The radiopaque section of the intravascular device 720 is visible in the fluoroscopic image 710. The fluoroscopic images 710 can correspond to a continuous stream of images and can be obtained while the patient's anatomy is exposed to a reduced radiation dose. It should be noted that the fluoroscopic images 710 can be acquired with the X-ray source 160 and the X-ray detector 170 positioned at any suitable angle with respect to the patient's anatomy. This angle is represented by angle 790.

[0077] The intravascular device 720 can be any suitable intravascular device. In the example shown, the device 720 can enclose a pressure-sensitive guidewire. As the pressure-sensitive guidewire moves through the patient's vascular system, the X-ray imaging system can acquire multiple fluoroscopic images 710 showing a radiopaque section of the pressure-sensitive guidewire. In this way, any in Fig. The X-ray image 710 shown depicts the pressure-sensitive guide wire positioned at a different location, so that the processor circuit 510 ( Fig. 5) can track the position of the pressure-sensitive guide wire during an intravascular co-registration procedure.

[0078] As the pressure-sensitive guidewire is pulled through the patient's vascular system, it can record pressure data. In one example, the pressure data can be measured in... Fig. The pressure data shown in Figure 7 represents 730 iFR measurements. However, the pressure data could be any suitable data, including FFR data, iFR data, or any other measurements or metrics relating to blood pressure, blood flow, or other physiological data acquired during guidewire withdrawal.

[0079] As the physician advances the pressure-sensitive guidewire through the patient's vascular system, each iFR data point 730 captured by the pressure-sensitive guidewire can be assigned to a position within a fluoroscopic image 710, as indicated by the arrow 761. For example, the in Fig. The first pressure data measurement 730 shown in Figure 7 may be linked to a location within the first fluoroscopy image 710. The first iFR measurement 730 may be a pressure ratio detected by the pressure-sensitive guidewire (in conjunction with the proximal pressure sensor catheter) at a position within the vascular system, as shown in the first fluoroscopy image 710 and indicated by the radiopaque section of the pressure-sensitive guidewire in the image 710. Similarly, an additional iFR measurement 730 may be linked to an additional fluoroscopy image 710, showing the pressure-sensitive guidewire at a new location within the image 710, and so on. The processor circuit can determine the locations of the pressure-sensitive guidewire within each acquired radiograph 710. The processor circuit 510 can identify a location of a pressure-sensitive guidewire using any suitable method.For example, the processor circuit 510 can perform various image processing techniques, such as edge detection of the X-ray dense marker, pixel-by-pixel analysis to determine the transition between light and dark pixels, filtering, or other suitable techniques to determine the location of the pressure-sensitive guidewire. In some embodiments, the processor circuit can use various artificial intelligence methods, including deep learning techniques such as neural networks or other suitable techniques, to identify the locations of the pressure-sensitive guidewire within the X-ray images 710.

[0080] During a pullback of the device, any suitable number of iFR data points 730 can be acquired and any suitable number of fluoroscopic images 710 can be obtained. In some embodiments, there can be a one-to-one ratio between fluoroscopic images 710 and iFR data 730. In other embodiments, the number of fluoroscopic images 710 can differ from the number of iFR data 730. The process of co-registering the iFR data 730 and / or intravascular data 830 (described with reference to Fig. 8) with one or more X-ray images may include some features similar to those described in U.S. Patent No. 7,930,014 entitled “VASCULAR IMAGE CO-REGISTRATION,” filed on January 11, 2006, which is hereby incorporated by reference in its entirety. The co-registration process may also include some features similar to those described in U.S. Patents Nos. 8,290,228, 8,463,007, 8,670,603, 8,693,756, 8,781,193, 8,855,744, and 10,076,301, which are likewise incorporated by reference in their entirety.

[0081] After a pullback procedure is completed, or during a pullback procedure, the system 100 can generate a fluoroscopy-based 2D path 740 defined by the positions of the pressure-sensitive guidewire within the X-ray fluoroscopy images 710. The different positions of the pressure-sensitive guidewire during withdrawal, as shown in the fluoroscopy images 710, can define a two-dimensional passage path 740, as indicated by the arrow 760. The fluoroscopy-based 2D passage path 740 reflects the path of the pressure-sensitive guidewire as it moves through the patient's vascular system, as viewed from angle 790 through the X-ray imaging device 152.The fluoroscopy-based 2D pass path 740 defines the path as measured by the X-ray device that acquired the fluoroscopy images 710 and therefore shows the path from the same angle 790 from which the fluoroscopy images were acquired. In other words, the 2D pass path 740 describes the projection of the 3D path followed by the device onto the imaging plane at the imaging angle 790. In some embodiments, the pass path 740 can be determined by averaging the detected locations of the pressure-sensitive guide wire in the fluoroscopy images 710. For example, the pass path 740 may not coincide exactly with the guide wire in any fluoroscopy image 710 selected for display. In some embodiments, the pass path 740 may not be displayed to a user.For example, all print data 730 can be linked to a specific coordinate within image 711. In this way, the print data 730 can be directly co-registered with image 711. The group of all coordinates linked to the print data 730 can define a passage path 740. In this way, iFR data can be directly linked to a section or location within the overview image 711.

[0082] Since the two-dimensional path 740, as shown by arrow 762, is generated based on the fluoroscopy images 710, each position along the two-dimensional path 740 can be associated with one or more fluoroscopy images 710. For example, the first fluoroscopy image 710 at a location 741 along the path 740 can represent the pressure-sensitive guide wire at the same location 741. Furthermore, since a correspondence has been established between the fluoroscopy images 710 and the iFR data 730, as shown by arrow 761, the iFR data 730, such as the first iFR measurement shown, can also be assigned to location 741 along the path 740, as shown by arrow 763.

[0083] Finally, the path 740, which is generated based on the positions of the pressure-sensitive guide wire within the fluoroscopy images 710, can be overlaid on any suitable fluoroscopy image 711 (e.g., one of the fluoroscopy images 710 in the fluoroscopy image stream). In this way, iFR data, such as an iFR measurement 730, can be assigned to each position along the path 740 displayed on the fluoroscopy image 711, as shown by arrow 764. For example, the in Fig. The first pressure value 730 shown in Figure 7 can be acquired simultaneously with the first radiograph image 710 shown, and the two can be linked, as shown by arrow 761. The radiograph image 710 can then indicate the position of the pressure-sensitive guide wire along path 740, as shown by arrow 762, and thus link the pressure value 730 to position 741 along path 740, as shown by arrow 763. Finally, the pressure value 730 can be linked to the location within the radiograph image 710 where it was acquired by overlaying path 740 with associated data onto the radiograph image 711. The radiograph path 740 itself may or may not be displayed on image 711.

[0084] In some embodiments, the co-registered iFR data are linked with a contrast-enhanced X-ray image (on which the vessel is visible), so that the position at which the iFR data are obtained is known in relation to the locations along the vessel.

[0085] Fig. Figure 8 is a diagrammatic view of a relationship between X-ray fluoroscopy images 810, intravascular ultrasound images 830 and a path 840 defined by the movement of an intravascular device according to the aspects of the present disclosure. Fig. Section 8 describes a method for co-registering intravascular data 830, including intravascular images, with corresponding sites on one or more fluoroscopic images 810 of the same region of a patient's anatomy. Aspects of co-registering intravascular data 830, including IVUS images, can be related to Fig. resemble the 7 concepts described.

[0086] In particular, the patient's anatomy can be imaged with an X-ray device while a physician performs a retraction with an intravascular device 820, for example, while the intravascular device 820 moves through a blood vessel of the anatomy. The intravascular device may be essentially similar to the intravascular device 102, which, with reference to Fig. 1C was described. The X-ray device used to obtain the fluoroscopic images 810 can be essentially the same as the X-ray device 152 of Fig. 1B. In some embodiments, the fluoroscopic images 810 can be obtained without the presence of contrast medium in the patient's vascular system. Such an embodiment is described by the fluoroscopic images 810 in Fig. Figure 8 shows that in other embodiments, a contrast medium is present in the patient's vascular system. In this respect, the fluoroscopic images 810 can alternatively be angiogram images or any suitable type of extraluminal image. The radiopaque section of the intravascular device 820 is visible in the fluoroscopic image 810. The fluoroscopic images 810 can correspond to a continuous stream of fluoroscopic images and can be obtained while the patient's anatomy is exposed to a reduced radiation dose. It should be noted that the fluoroscopic images 810 can be acquired with the X-ray source 160 and the X-ray detector 170 positioned at any suitable angle with respect to the patient's anatomy. This angle is represented by angle 890.

[0087] The intravascular device 820 can be any suitable intravascular device. As the intravascular device 820 moves through the patient's vascular system, the X-ray imaging system can acquire multiple fluoroscopic images 810 showing the radiopaque section of the intravascular device 820. In this way, any in Fig. Figure 810 shows the intravascular device 820 positioned at a different location so that a processor circuit can track the position of the intravascular device 820 over time.

[0088] While the intravascular device 820 is being pulled through the patient's vascular system, it can acquire intravascular data 830. In one example, the data in Fig. The intravascular data shown in Figure 8 may be 830 IVUS images. However, the intravascular data could be any suitable data, including IVUS images, OCT images, intravascular photoacoustic (IVPA) images, or any other measurement or metric relating to lumen structure or other physiological data acquired during the withdrawal of an intravascular device.

[0089] As the physician advances the intravascular device 820 through the patient's vascular system, each intravascular data point 830 detected by the intravascular device 820 can be assigned to a position within the patient's anatomy in the fluoroscopic images 810, as indicated by the arrow 861. For example, the in Fig. The first IVUS image 830 shown can be assigned to the first fluoroscopy image 810. The first IVUS image 830 can be an image acquired by the intravascular device 820 at a position within the vascular system, as shown in the first fluoroscopy image 810, as depicted by the intravascular device 820 in image 810. Similarly, an additional IVUS image 830 can be linked to an additional fluoroscopy image 810, showing the intravascular device 820 at a new location within image 810, and so on. The processor circuitry can determine the locations of the intravascular device 820 within each acquired X-ray image 810 using any suitable method.For example, the processor circuit can perform various image processing techniques, such as edge detection of the X-ray dense marker, pixel-by-pixel analysis to determine the transition between light and dark pixels, filtering, or other suitable techniques to determine the location of the imaging device 820. In some embodiments, the processor circuit can use various artificial intelligence methods, including deep learning techniques such as neural networks or other suitable techniques, to identify the locations of the imaging device 820 within the X-ray images 810.

[0090] Any suitable number of IVUS images or other intravascular data points 830 can be acquired during a pullback of the intravascular device, and any suitable number of fluoroscopic images 810 can be obtained. In some embodiments, there can be a one-to-one ratio between fluoroscopic images 810 and intravascular data 830. In other embodiments, the number of fluoroscopic images 810 can differ from the number of intravascular data 830.

[0091] The system 100 can additionally generate a fluoroscopy-based 2D passage path 840, defined by the positions of the intravascular device 820 within the X-ray fluoroscopy images 810. The different positions of the intravascular device 820 during withdrawal, as shown in the fluoroscopy images 810, can define a two-dimensional passage path 840, as indicated by the arrow 860. The fluoroscopy-based 2D passage path 840 reflects the path of one or more radiopaque sections of the intravascular device 820 as it moves through the patient's vascular system, as viewed from angle 890 by the X-ray imaging device 152.The fluoroscopy-based 2D passage path 840 defines the path as measured by the X-ray device that acquired the fluoroscopy images 810 and therefore shows the path from the same angle 890 from which the fluoroscopy images were acquired. In other words, the 2D passage path 840 describes the projection of the 3D path followed by the device onto the imaging plane at the imaging angle 890. In some embodiments, the passage path 840 can be determined by averaging the detected locations of the intravascular device 820 in the fluoroscopy images 810. For example, the passage path 840 may not coincide exactly with the guidewire in any of the fluoroscopy images 810 selected for display. However, it should be noted that the imaging catheter 102, as described in [reference to relevant section], Fig. 1A, Fig. 1B, Fig. 1C, Fig. 2, Fig. 3 and Fig. As described in section 4, the device is positioned to move along the guide wire. In some embodiments, the passage path 840 may not be displayed to a user. For example, each IVSU image 830 may be linked to a specific coordinate within image 811. In this way, the print data 830 can be directly co-registered with image 811. The group of all coordinates linked to the print data 830 can define a passage path 840. In this way, IVUS images can be directly linked to a section or location within the overview image 811.

[0092] Since the two-dimensional path 840, as shown by arrow 862, is generated based on the fluoroscopy images 810, each position along the two-dimensional path 840 can be associated with one or more fluoroscopy images 810. For example, the first fluoroscopy image 810 at a location 841 along path 840 can represent the intravascular device 820 at the same location 841. Furthermore, since a correspondence between the fluoroscopy images 810 and the iFR data 830 has also been established, as shown by arrow 861, the intravascular data 830, such as the first IVUS image shown, can also be associated with location 841 along path 840, as shown by arrow 863.

[0093] Finally, path 840, generated based on the locations of the intravascular device 820 within the fluoroscopic images 810, can be overlaid on any suitable fluoroscopic image 811 (e.g., one of the fluoroscopic images 810 in the fluoroscopic image stream). In this way, IVUS data such as an IVUS image 830 can be assigned to each location along path 840 displayed on the fluoroscopic image 811, as shown by arrow 864. For example, the in Fig. The IVUS image 830 shown can be acquired simultaneously with the fluoroscopy image 810 shown, and the two can be linked together, as shown by arrow 861. The fluoroscopy image 810 can then indicate the location of the intravascular device 820 along path 840, as shown by arrow 862, and thus link the IVUS image 830 to the position 841 along path 840, as shown by arrow 863. Finally, the IVUS image 830 can be linked to the location within the fluoroscopy image 810 where it was acquired by overlaying path 840 with associated data onto the fluoroscopy image 811. The transit path 840 itself may or may not be displayed on image 811.

[0094] In the illustrated embodiment of Fig. 8. The co-registered IVUS images are linked with one of the fluoroscopic images acquired without contrast, so that the position at which the IVUS images are obtained is known in relation to the locations along the guidewire. In other embodiments, the co-registered IVUS images are linked with a contrast-enhanced X-ray image (on which the vessel is visible), so that the position at which the IVUS images are obtained is known in relation to the locations along the vessel.

[0095] Fig. Figure 9 is a diagrammatic view of a relationship between intravascular images co-registered with an extraluminal image, pressure data co-registered with an extraluminal image, and a longitudinal view based on the intravascular images and pressure data according to the aspects of this disclosure. In particular, Fig. 9 a relationship between the overview radiograph 711 and the co-registered iFR data 730 ( Fig. 7) and the overview X-ray image 811 and the co-registered IVUS imaging data 830 ( Fig. 8) illustrate. In this way, describe Fig. 9 a method for co-registering iFR data 730 with IVUS images 830 of the same region of a patient's anatomy.

[0096] In some respects, physiological data can be overlaid on an IVUS longitudinal cross-sectional image (e.g., an ILD). Co-registration of physiological and IVUS data allows the user to better understand the physiological data associated with a specific IVUS image, as well as the context of the entire imaged and / or measured segment of the vessel. Co-registration is a useful differentiating feature in the diagnosis and treatment of coronary artery disease (CAD). By co-registering imaging and physiological data within an angiogram and / or with each other, the physician can more easily understand the patient's coronary anatomy and determine optimal treatment pathways.

[0097] The one with reference to Fig. The described path 740 can include position data and iFR data. For example, path 740 can contain iFR data (e.g., data 730 from Fig. 7) with locations along the vessel (e.g. vessel 690 from Fig. 6) Link. For example, each iFR value 730 can correspond to a position coordinate which, together with the other iFR data position coordinates, defines the passage path 740. The position coordinate of the first iFR value received can correspond to a starting point of the pressure guide wire and can be the starting point of the passage path 740. The last iFR value received can correspond to an ending point. A length along the vessel and / or guide wire between the starting point and the ending point can define a length of the passage path 740. In one embodiment, each iFR value is linked to a two-dimensional coordinate that specifies a location within the overview image 711. In another embodiment, each iFR value is linked to a one-dimensional coordinate of a distance measurement from the starting point. In this embodiment, the starting point can correspond to an origin or a distance of zero.

[0098] The one with reference to Fig. The described path 840 can include similar site data as well as IVUS imaging data. For example, path 840 can contain IVUS imaging data (e.g., IVUS data 830 from Fig. 8) with locations along the vessel (e.g. vessel 690 from Fig. 6) Link them. For example, each IVUS image 830 can correspond to a position coordinate which, together with the other IVUS image position coordinates, defines the transit path 840. As with the transit path 740, the position coordinate of the first received IVUS image can correspond to a starting point of the imaging device and be the starting point of the transit path 840. The last received IVUS image can correspond to an ending point. A length along the vessel and / or guide wire between the starting point and the ending point can define a length of the transit path 840. In one embodiment, each IVUS image is linked to a two-dimensional coordinate that specifies a location within the overview image 811. In another embodiment, each IVUS image is linked to a one-dimensional coordinate representing a distance measurement from the starting point.In this embodiment, the starting point can correspond to an origin or a distance of zero.

[0099] In an embodiment in which the iFR data and the IVUS images are each linked to a two-dimensional coordinate that identifies a location within the overview image 711 and the overview image 811, respectively, iFR data and IVUS images acquired at the same location along the vessel can be co-registered based on the same or substantially similar two-dimensional coordinates. In this embodiment, the overview image 711 and the overview image 811 can be the same image or substantially the same image.

[0100] In an embodiment where the iFR data and IVUS images are each assigned a one-dimensional length indicating a distance from a given location, a distance can be determined between the location of the iFR pass path 740 and the location of the IVUS imaging pass path 840. This distance can be used as an offset to align the one-dimensional distance coordinates of the iFR data with the same locations as the IVUS images. In this embodiment, the overview image 711 and the overview image 811 can be the same image or different from each other.

[0101] Due to the relationship between the passage path 740 and the accompanying iFR data at locations along the patient vessel, and the relationship between the passage path 840 and the accompanying IVUS image data at locations along the same vessel, iFR data and IVUS image data can be displayed together at the same locations along the vessel, as in the longitudinal view 910 of the body lumen and via the in Fig. The data is shown in section 9. The longitudinal view can be referred to as the Image Longitudinal Display (ILD) view or the Inline Digital (ILD) view.

[0102] The acquired IVUS images can be used to generate the ILD 910. In this context, an IVUS image is a tomographic or radial cross-sectional view of the blood vessel. The ILD 910 provides a longitudinal cross-sectional view of the blood vessel. The ILD 910 can be a stack of IVUS images acquired at various positions along the vessel, such that the longitudinal view of the ILD 910 is perpendicular to the radial cross-sectional view of the IVUS images. In such an embodiment, the ILD 910 can show the length of the vessel, whereas a single IVUS image is a single radial cross-sectional image at a given location along its length. In another embodiment, the ILD 910 can be a stack of IVUS images acquired during the imaging procedure, and the length of the ILD 910 can represent the time or duration of the imaging procedure. The ILD 910 can be generated and displayed in real time or near real time during the pullback procedure.Each additional IVUS image can be added during ILD 910 acquisition. For example, the one in . Fig. Figure 9 shows that the ILD 910 may be partially completed at one point during the pullback procedure. In some embodiments, the processor circuitry can generate a visualization of a longitudinal view of the vessel being imaged based on the received IVUS images. Instead of displaying actual vessel image data, as is the case with the ILD 910, the visualization may be a stylized version of the vessel, where, for example, solid lines indicate the lumen boundary and the vessel boundary.

[0103] As an example, indicator 912 can identify a location along the vessel, as shown in ILD 910. This indicator 912 can simultaneously correspond to location 741 along passage path 740 and to the same location 841 along passage path 840. Consequently, the IVUS image obtained at location 841 can be displayed at the location of indicator 912 as part of ILD 910, as shown by arrow 961. Similarly, the iFR value associated with location 741 can be overlaid on ILD 910 at the same location of indicator 912, as shown by arrow 963.

[0104] All iFR values ​​obtained and associated with the 740 path can be overlaid on the 910 ILD. Line 914 provides an example of how iFR values ​​can be displayed to a user. As shown by indicators 918 and 920, a graph can be overlaid on the 910 ILD. For example, a minimum iFR value can correspond to indicator 920, and a maximum value to indicator 918. The vertical position of line 914 on the 910 ILD can correspond to an iFR value that is between the minimum and maximum values. For example, the pressure data at the most distal position along the 910 ILD can be a minimum, as shown by line 914, which is positioned near the bottom of the 910 ILD and is aligned with, or at the same vertical position as, the minimum value of 920. Similarly, the pressure data at the proximal end can be a maximum.This is shown by line 914, which is aligned above ILD 910 with the maximum value 918, or is located in the same vertical position. In some embodiments, a user can select a segment of line 914 and / or line 916 (described below), and System 100 can display the iFR value associated with the selected location. System 100 can also display the iFR value of the position of indicator 912.

[0105] System 100 can perform any suitable processing of the iFR or IVUS image data. For example, the system's processor circuit 510 can perform averaging, smoothing, segmentation, grouping, or any other suitable data processing before or after the data is displayed to a user. In one example, the in Fig. Line 914, shown, represents processed iFR data. The 510 circuit can also be configured to display raw iFR data simultaneously. The raw iFR data can be shown by the line. Visual representations of the raw iFR data and the processed iFR data can be visually distinguished in any way, such as by different colors, patterns, transparency, or other forms of highlighting or differentiation. The 510 processor circuit can display lines 914 and 916 simultaneously or separately.

[0106] The 510 processor circuit can be configured to perform length measurements of any device or any anatomical structure or feature within an extraluminal image. Length measurements can include, for example, the length of a withdrawal path (such as the withdrawal path of an intravascular imaging device and / or a pressure sensor device), the lengths of recommended stents, the lengths between points of interest, or any other lengths. Length measurements can be performed automatically by the 510 processor circuit or in response to user input. Length measurements can be based, at least in part, on a radiopaque section of the pressure-sensitive wire. For example, a radiopaque section of the guidewire may have a known length (such as 3 cm). The system can use this length as a reference to determine the length of other features within the image.A similar method can be applied using radiopaque sections of IVUS imaging devices. For example, in some embodiments, the transducer section of an intravascular imaging device may be constructed of a radiopaque material and have known dimensions. Additional markings of known length for comparison, to be performed by the processor circuit 510, may also be present.

[0107] In some embodiments, errors may be present in the IVUS pullback site data. Additionally, errors may be present in the site data along the physiological pullback. Because IVUS site data and physiological data are co-registered to an extraluminal image, errors from both the IVUS pullback site information and the physiological pullback information stack. To relate these stacked errors, the system can generate and display error bars that are linked to either the iFR data (points 1114 or lines 914 and 916) or the IVUS data. These error bars can be displayed along the ILD or an extraluminal image, helping the user understand the presence and extent of errors associated with the displayed site data.

[0108] Fig. Figure 10 is a diagrammatic view of an image-based longitudinal view of a lumen with co-registered print data according to aspects of the present disclosure. Fig. Figure 10 shows a representation of a stent 1010 along the ILD. In this respect, the stent 1010 can be placed over the ILD 910. A recommendation for stent placement can be made automatically by the processor circuit 510. This recommendation can include the stent type, stent length, stent diameter, proximal and distal landing zones for a stent, and the number of stents recommended or other suitable stent parameters. In some embodiments, the stent recommendation can be based on iFR data, IVUS image data, the locations of the side branches of the imaged / measured vessels, the spacing between successive or row stents, or other factors. Aspects of the automatic stent recommendation can include features described in preliminary US application No. 63 / 288,554 dated November 11, 2011.December 2021, entitled “AUTOMATIC SEGMENTATION AND TREATMENT PLANNING FOR A VESSEL WITH COREGISTRATION OF PHYSIOLOGY DATA AND EXTRALUMINAL DATA”, which is hereby incorporated in its entirety by reference. In some embodiments, the representation of the stent 1010 can represent a virtual stent or a planned stent. In some embodiments, the representation of the virtual stent 1010 can be positioned manually by user input via a user input device (e.g., touchscreen display, mouse / keyboard, etc.). For example, the processor circuit 510 can be configured to receive user input providing instructions for adjusting the location, length, etc., of the stent. The user can determine the placement of the stent or other features of the stent based on the iFR data and / or IVUS image data represented by line 914.In other embodiments, the graphic element 1010 shown superimposed on ILD 910 may not be a stent, but may be any other suitable treatment. For example, the graphic element 1010 may represent an angioplasty device, a balloon, an atherectomy device, or another treatment device.

[0109] In some implementations, line 914 may alternatively be referred to as a trend line. In some implementations, line 914 may be based on physiological data measured by a physiological measuring device. For example, line 914 may be based on pressure measurements within a blood vessel. In some implementations, line 914 may illustrate iFR values. In some implementations, the iFR values ​​corresponding to line 914 may be based on pressure measurements acquired by a pressure guide wire at a distal location and pressure measurements acquired simultaneously by a pressure sensor at a proximal location, such as one positioned on a guide catheter.In some implementations, a pressure device for measuring iFR values ​​can be positioned in a renal artery, with one pressure sensor positioned on a pressure guide wire that receives measurements in the renal artery, and another pressure sensor positioned on a guide catheter within the aorta to measure pressure. In some implementations, proximal or distal pressure measurements can be taken via an aortic catheter. The values ​​on line 914 can therefore correspond to a pressure ratio between any two of these pressure sensors.

[0110] Fig. 10 also shows a region 1014. As in Fig. As shown in Figure 10, line 914, corresponding to the iFR data, terminates at a point proximal to region 1014. This may be because region 1014 was imaged with an IVUS imaging device but not measured with the pressure-sensitive guidewire. Consequently, region 1014 may show an image-based portion of the ILD but may not include overlaid iFR data. In the Fig. In the example shown in 10, region 1014 can therefore be the one in Fig. 6 shown and described region 614.

[0111] Region 1015 in Fig. Figure 10 is also shown. It is shown that the image data included as part of ILD 910 terminates at a point distal to region 1015. This may be because region 1015 was measured with a pressure-sensitive guidewire but not imaged with the IVUS device. Consequently, region 1015 may show 1FR data of lines 914 and / or 916, but no image-based data corresponding to the data acquired with the IVUS imaging device. In the Fig. The example shown in 10 can therefore be the region 1015 in Fig. 6 shown and described region 615.

[0112] As shown in regions 1014 and / or 1015, one or more offsets may be caused by regions of the vessel that are measured only with the intravascular device or the pressure pullback device. Consequently, the system may perform various calibration procedures to ensure that the locations of the intravascular image data correspond to the locations of the corresponding pressure data. For example, the system may perform a calibration to ensure that the pressure data is co-registered at the same location as the corresponding IVUS data. In some cases, the physiological pullback length (e.g., path 603) is longer than the IVUS pullback length (e.g., path 605), as shown above right in ILD 910 (e.g., region 1015).Since both the physiological pullback and IVUS pullback paths originate from a reference point that can be offset or calibrated, the locations along the physiological pullback can correspond to the locations along the IVUS pullback. For example, intraluminal images (e.g., IVUS images) can be correlated with first corresponding positions along a patient's body lumen through one of the co-registration steps described previously. Intraluminal physiological measurements (e.g., iFR measurements) can be correlated similarly with second corresponding positions along the same body lumen of the patient. In this example, one, some, or all of the first positions of the intraluminal images could be identical to, or different from, one, some, or all of the second positions of the intraluminal physiological measurements.In some implementations, the intraluminal images and the physiological measurements can correspond to the same locations along the body lumen.

[0113] Fig. Figure 11 is a diagrammatic view of an image-based longitudinal view 1110 of a lumen with co-registered print data according to the aspects of the present disclosure. Fig. Figure 11 may show an additional method for displaying superimposed iFR data across an ILD (e.g., ILD 1110). As in Fig. As shown in Figure 11, several points 1114 can be placed over ILD 1110. ILD 1110 can be essentially similar to the previously shown ILD 910.

[0114] In the Fig. In the embodiment shown in Figure 11, each point 1114 can correspond to a change in the pressure ratio (e.g., iFR). For example, in some embodiments, the presence of a point 1114 at a particular location can correspond to a pressure ratio change of 0.01. A point 1114 can be associated with any suitable pressure ratio change other than 0.01. This value can be determined by the processor 510 or the user of the system 100. The points 1114 shown, superimposed on the ILD 1110, can be positioned at any suitable location, including above the ILD 1110, near the ILD 1110, or at any other location.

[0115] It should also be noted that the dots 1114 can have any suitable appearance. In particular, the dots 1114 are shown and described as round dots in the present disclosure for educational purposes only.

[0116] For example, the dots 1114 can have any suitable shape, pattern, size, or any other visual appearance.

[0117] Fig. Figure 12 is a diagrammatic view of a measurement-based longitudinal view 1210 of a lumen with co-registered pressure data according to aspects of the present disclosure. Fig. Figure 12 may show an additional method for displaying superimposed iFR data over an ILD (e.g., ILD 1210). As in Fig. As shown in Figure 12, multiple points 1114 can be placed over an ILD 1210.

[0118] In some embodiments, the ILD 1210 may include a stylized ILD. In particular, a stylized ILD may be an ILD generated based on lumen measurements, as opposed to one generated based on IVUS images. For example, and with reference to Fig. The ILD 1110 can be primarily based on IVUS images, while the stylized ILD 1210 can be based on intraluminal measurements of the imaged vessel and / or lumen. For example, the stylized ILD 1210 includes lines 1212 and 1214. Lines 1212 can correspond to the vessel wall of the imaged vessel. For example, during an imaging procedure, the processor circuit 510 can automatically identify the vessel wall in each of the received IVUS images. The processor circuit 510 can determine the distance from the imaging catheter to the vessel wall in every direction around the catheter in each of the IVUS images. Based on these measurements (e.g., the identification of the vessel wall and the distance from the wall to the catheter), the processor circuit can determine an average diameter of the vessel for each IVUS image at any point along the vessel.These average diameters can be verified with corresponding IVUS images and corresponding locations along the passage path 840 (. Fig. 8) are linked. The lines 1212 can then be generated as symmetrical lines around a center line along the ILD 1210 and spaced apart from each other based on the average diameter of the vessel wall at that point. This allows a user of the system 100 to easily identify the vessel wall along the depicted section of the vessel by presenting a clearly identified and simplified representation of the vessel wall. In some embodiments, the ILD 1210 can be referred to as a vessel reconstruction.

[0119] Similarly, a stylized representation of the lumen can be identified and shown by lines 1214. Lines 1214 can correspond to the lumen boundary of the imaged vessel. For example, during an imaging procedure, the processor circuit 510 can automatically identify the lumen boundary in each of the received IVUS images. The processor circuit 510 can additionally determine a distance from the imaging catheter to the lumen boundary in every direction around the catheter in each of the IVUS images. Based on these measurements (e.g., the identification of the lumen boundary and the distance from the lumen boundary to the catheter), the processor circuit can determine an average diameter of the lumen boundary for each IVUS image. These average diameters can be compared with corresponding IVUS images and corresponding locations along the passage path 840 ( Fig. 8) can be linked. The lines 1214 can then be generated symmetrically around a center line along the ILD 1210 and spaced apart based on the average diameter of the lumen boundary at that point. This allows a user of System 100 to easily identify the lumen boundary along the depicted section of the vessel by presenting a clearly identified and simplified representation of the boundary.

[0120] Examples of edge detection, image processing, image analysis and / or pattern recognition include US Patent No. 6,200,268 entitled "VASCULAR PLAQUE CHARACTERIZATION", granted on March 13, 2001, with D. Geoffrey Vince, Barry D. Kuban and Anuja Nair as inventors; US Patent No. 6,381,350 entitled "INTRAVASCULAR ULTRASONIC ANALYSIS USING ACTIVE CONTOUR METHOD AND SYSTEM", granted on April 30, 2002, with Jon D. Klingensmith, D. Geoffrey Vince and Raj Shekhar as inventors; US Patent No. US Patent No. 7,074,188 entitled “SYSTEM AND METHOD OF CHARACTERIZING VASCULAR TISSUE”, granted on July 11, 2006, with Anuja Nair, D. Geoffrey Vince, Jon D. Klingensmith, and Barry D. Kuban as inventors; US Patent No. 7,175,597 entitled “NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD”, granted on February 13, 2007, with D. Geoffrey Vince, Anuja Nair, and Jon D. Klingensmith as inventors; US Patent No. 7,215,802 entitled “SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION”, granted on May 8, 2007, with Jon D.Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince as inventors, US Patent No. 7,359,554 entitled "SYSTEM AND METHOD FOR IDENTIFYING A VASCULAR BORDER," granted on April 15, 2008, with Jon D. Klingensmith, D. Geoffrey Vince, Anuja Nair, and Barry D. Kuban as inventors, and US Patent No. 7,463,759 entitled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," granted on December 9, 2008, with Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince as inventors, whose teachings are hereby incorporated by reference in their entirety.

[0121] Lines 1212 and 1214 can be used by one user simultaneously, as in Fig. Lines 12 and 1214 can be shown together or displayed separately. When shown simultaneously, the user can easily distinguish the diameter of the vessel wall from the diameter of the lumen boundary at any point along the depicted vessel and quickly and easily assess the extent of any constrictions within the depicted vessel. Lines 1212 and 1214 can be distinguished from each other using any of the methods described herein.

[0122] The points 1114 can additionally be superimposed on the stylized ILD 1210, as shown in Fig. 12 shown. Points 11-14 may be the same as those referred to in relation to Fig. The combination of a stylized representation of the vessel wall (e.g., lines 1212), a stylized representation of the lumen boundary (e.g., lines 1214), and the points 1114, which represent a change in pressure conditions along the vessel, provides a user of System 100 with accurate and concise views of the degree of narrowing within a vessel. Using this data, the user can quickly and accurately identify locations within the vessel where treatment is required and what types of treatment are necessary.

[0123] As in Fig. As shown in Figure 12, the representation of the vessel wall by lines 1212 can include breaks in lines 1212. These breaks can correspond to vessel side branches. The locations of these side branches can be determined automatically by the processor circuit 510 or identified by a user of the system either on an extraluminal image, IVUS images, or the ILD shown.

[0124] It should also be noted that print data in conjunction with the ILD 1210 can be displayed in any desired manner. For example, lines similar to lines 914 and / or 916 can be overlaid on the measurement-based ILD 1210. In this way, the chart style for displaying the print ratio data, which is related to Fig. 9 and Fig. 10 was shown and described, including lines 914 and 916 as well as indicators 918 and 920, also via the in Fig. The stylized ILDs shown in Figure 12 can be placed. For example, the stylized ILD 1210 can include points 1114 and / or lines 914 and 916 and the accompanying indicators 918 and 920. All ILDs described herein can also include all forms of pressure change data described or shown herein.

[0125] Fig. 13 is a diagrammatic view of an image-based longitudinal view 1310 of a lumen with co-registered print data according to aspects of the present disclosure. Fig. Figure 13 shows an additional ILD 1310. The ILD 1310 can represent multiple stents. As shown in Fig. Figure 13 shows, for example, a stent 1315 placed over the ILD 1310, and an additional stent 1320 may be shown placed over the ILD 1310. In some embodiments, the stent 1315 and the stent 1320 may be virtual stents. For example, the stents 1315 and 1320 shown along line 1310 may be recommended sites for stent placement within the vessel.

[0126] In some embodiments, the stent 1315 can correspond to a virtual stent that is automatically selected by the processor circuit 510 according to the parameters relating to Fig. The 10 principles described herein are recommended. The Stent 1320 can correspond to a virtual stent that is manually placed by the system user. For example, the System 100 can provide the user with a graphical user interface that allows the user to select a stent of any type and size and place it anywhere along the ILD 1310. In this way, the user can use the ILD 1310 (or any other ILD described herein) to plan stent deployment.

[0127] In some embodiments, the system can predict a virtual change in the pressure data after a virtual stent (e.g., stents 1010, 1315, or 1320) has been recommended, selected, designated, or shown. For example, the system can predict modified versions of lines 914 and 916 ( Fig. 9) and / or points 1114 ( Fig. 11) generate, which show the predicted change in pressure data. Aspects of predicting changes in virtual stent pressure data may include various features, including those described in the preliminary U.S. application No. 63 / 288,554 dated December 11, 2021, entitled “AUTOMATIC SEGMENTATION AND TREATMENT PLANNING FOR A VESSEL WITH COREGISTRATION OF PHYSIOLOGY DATA AND EXTRALUMINAL DATA,” which was previously incorporated. In some embodiments, the predicted modified pressure data may be displayed simultaneously with the pretreatment of the pressure data (e.g., lines 914 and 916 or points 1114). In some embodiments, the predicted modified pressure data may be displayed separately from the pretreatment data.

[0128] Fig. Figure 14 is a diagrammatic view of a graphical user interface 1400 according to the aspects of the present disclosure. The graphical user interface 1400 can be displayed to a user after an IVUS pullback and a pullback of intraluminal physiological measurements have been performed and IVUS images and physiological measurements have been co-registered at positions along the longitudinal view (e.g., an ILD 1450) and / or an extraluminal image (e.g., an X-ray image 1410).

[0129] The 510 processor circuit can be configured to co-register any intraluminal data (including IVUS images or iFR pressure ratio data) to a passage path (e.g., passage path 740 and / or passage path 840). For example, IVUS imaging data and / or physiological data can be associated with locations along a passage path. When this passage path is overlaid on an extraluminal image, this intraluminal data can be displayed corresponding to the locations within the extraluminal image, illustrating where along a vessel, as shown by the passage path, this intraluminal data was acquired. As previously described, intraluminal physiological data can also be overlaid on a longitudinal view of a body lumen. As in Fig. As shown in Figure 14, both an extraluminal image with co-registered intraluminal data and a longitudinal view with co-registered physiological data can be displayed on the same screen.

[0130] 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 depicted vessel. The X-ray image 1410 can include a representation of a passageway 1440. The passageway 1440 can be derived from the passageway 740. Fig. 7 resemble and / or the passage path 840 from Fig. 8 resemble. In some embodiments, the passage path 1440 can be a passage path corresponding to the movement of an intravascular imaging catheter. The passage path 1440 can be superimposed on the image 1410 and can identify the location of the imaged blood vessel. Various indicators relating to co-registered intraluminal data, as shown in [reference], can be displayed along or adjacent to this passage path 1440. Fig. 14 shown and with reference to Fig. 15 is described in more detail.

[0131] For example, iFR data 1490 can be co-registered with the through path 1440. For example, during an iFR retreat, iFR data can be received by the processor circuit 510 while simultaneously receiving extraluminal images (e.g., image 710 from Fig. 7) When iFR data are acquired and correlated with locations within the extraluminal images, the iFR data can be identified at locations along the passage path 1440. For example, an indicator 1422 can be provided along path 1440. The indicator 1422 can correspond to the location along path 1440 where iFR data 1490, such as the iFR estimation metric, was acquired. Likewise, an indicator 1494 can be provided in image 1410 along the passage path 1440. The indicator 1494 can identify the distal location where the iFR data 1490 was acquired, such as the distal iFR value shown as part of the data 1490.

[0132] The graphical user interface 1400 also displays the IVUS image 1430. In this respect, a variety of IVUS images (including image 1430) can be co-registered with the pass path 1440. The IVUS image 1430 can be an IVUS image obtained at the location identified by indicator 1422. Alternatively, the IVUS image 1430 can be an IVUS image obtained at the location identified by indicator 1494. In some embodiments, the IVUS image 1430 can include a boundary 1432. This boundary can be automatically identified by the processor circuit 510 or identified by a user of the system. In some embodiments, the boundary 1432 can be a lumen boundary, a vessel boundary, a stent boundary, or any other boundary within the image.

[0133] Examples of edge detection, image processing, image analysis and / or pattern recognition include US Patent No. 6,200,268 entitled "VASCULAR PLAQUE CHARACTERIZATION", granted on March 13, 2001, with D. Geoffrey Vince, Barry D. Kuban and Anuja Nair as inventors; US Patent No. 6,381,350 entitled "INTRAVASCULAR ULTRASONIC ANALYSIS USING ACTIVE CONTOUR METHOD AND SYSTEM", granted on April 30, 2002, with Jon D. Klingensmith, D. Geoffrey Vince and Raj Shekhar as inventors; US Patent No. US Patent No. 7,074,188 entitled “SYSTEM AND METHOD OF CHARACTERIZING VASCULAR TISSUE”, granted on July 11, 2006, with Anuja Nair, D. Geoffrey Vince, Jon D. Klingensmith, and Barry D. Kuban as inventors; US Patent No. 7,175,597 entitled “NON-INVASIVE TISSUE CHARACTERIZATION SYSTEM AND METHOD”, granted on February 13, 2007, with D. Geoffrey Vince, Anuja Nair, and Jon D. Klingensmith as inventors; US Patent No. 7,215,802 entitled “SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION”, granted on May 8, 2007, with Jon D.Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince as inventors, U.S. Patent No. 7,359,554 entitled "SYSTEM AND METHOD FOR IDENTIFYING A VASCULAR BORDER," granted on April 15, 2008, with Jon D. Klingensmith, D. Geoffrey Vince, Anuja Nair, and Barry D. Kuban as inventors, and U.S. Patent No. 7,463,759 entitled "SYSTEM AND METHOD FOR VASCULAR BORDER DETECTION," granted on December 9, 2008, with Jon D. Klingensmith, Anuja Nair, Barry D. Kuban, and D. Geoffrey Vince as inventors, whose teachings are hereby incorporated by reference in their entirety.

[0134] Additionally, the metrics 1434 are displayed in interface 1400. The metrics 1434 can relate to the displayed IVUS image 1430 and, in particular, to the boundary 1432. For example, the processor circuit 510 can automatically calculate various metrics 1434 that relate to the boundary 1432. For example, the processor circuit 510 can identify a cross-sectional area of ​​the boundary 1432. The circuit can also identify a minimum diameter of the boundary, a maximum diameter of the boundary, or any other measurements or metrics related to the boundary 1432 or other aspects of the image 1430.

[0135] In some embodiments, the longitudinal view 140 can also be displayed. The longitudinal image 1450 can be referred to as the digital inline display (ILD) or intravascular longitudinal display (ILD) 1450. The IVUS images acquired during an intravascular ultrasound imaging procedure, such as during an IVUS pullback, can be used to generate the ILD 1450. In this respect, an IVUS image is a tomographic or radial cross-sectional view of the blood vessel. The ILD 1450 provides a longitudinal cross-sectional view of the blood vessel. The ILD 1450 can be a stack of IVUS images acquired at various positions along the vessel, such that the longitudinal view of the ILD 1450 is perpendicular to the radial cross-sectional view of the IVUS images. In such an embodiment, the ILD 1450 can show the length of the vessel, whereas a single IVUS image is a single radial cross-sectional image at a given location along the length.In another embodiment, the ILD 1450 can be a stack of IVUS images acquired during the imaging procedure, and the length of the ILD 1450 can represent the time or duration of the imaging procedure. The ILD 1450 can be generated and displayed in real time or near real time during the pullback procedure. Each additional IVUS image can be added to the ILD 1450 upon acquisition. For example, the one in . Fig. Figure 9 shows that the ILD 1450 may be partially completed at one point during the pullback procedure. In some embodiments, the processor circuitry can generate a visualization of a longitudinal view of the vessel to be imaged based on the received IVUS images. Instead of displaying actual vessel image data, for example, the visualization may be a stylized version of the vessel, where, for example, solid lines indicate the lumen boundary and the vessel boundary. As shown in Fig. As shown in Figure 12, the ILD 1450 can represent a stylized ILD where the lumen boundary 1214 extends as continuous lines across the ILD 1450. The location of the lumen boundaries 1214 can be positioned symmetrically around a central axis and can be positioned according to the lumen diameter calculated in each corresponding IVUS image.

[0136] The ILD 1450 can include a representation of iFR data 1492, various length measurements 1462, indicators 1452 and 1456 that identify the beginning and end of a length measurement, and bookmark identifiers 1454.

[0137] In some embodiments, the iFR data 1492 can be the same iFR data used to populate the described metrics 1490. As shown in the ILD 1450, and because the ILD 1450 is generated based on IVUS data, if two intraluminal procedures (e.g., IVUS data and physiological data) are performed and co-registered on the same transit path (e.g., transit path 1440), the same IVUS and physiological data can be co-registered together, as shown by the iFR data 1492 shown at locations along the ILD 1450. The iFR data 1492 can be used with reference to Fig. The ILD 1450 may resemble line 914 as described in section 10. ILD 1450 may additionally include iFR data 1493. In some implementations, iFR data 1493 may correspond to raw iFR data, and iFR data 1492 may correspond to processed iFR data. iFR data 1493 may be related to the Fig. 10 resemble line 916 as described.

[0138] The ILD 1450 can include additional or alternative physiological measurement data besides the iFR data 1492 and 1493. For example, physiological data overlaid on the ILD 1450 can include points that correspond to the values ​​in Fig. 11 and Fig. The 12 points shown and described resemble 1114. Additionally, the ILD 1450 may be an image-based longitudinal view of the lumen, as in Fig. 14 shown, or to provide a measurement-based longitudinal view similar to longitudinal view 1210, which is shown in Fig. 12 is shown.

[0139] Length measurements along the ILD 1450 can be generated by a user of the System 100 and / or automatically by the processor circuit 510. For example, a user can select various locations along the ILD 1450, and the processor circuit can calculate length measurements corresponding to the selected locations. These various length measurements can also be displayed as metrics 1460 near the ILD 1450. In some embodiments, length measurements can be distinguished from one another by labels, colors, patterns, highlights, or other visual characteristics.

[0140] Indicators 1452 and 1456 can be user-selected locations along the ILD 1450. In some embodiments, they can be selected automatically. For example, indicators 1452 and 1456 can identify the start and end points of a length measurement. In some embodiments, indicators 1452 and 1456 correspond to a distal and proximal landing zone for a stent under consideration by a physician. The iFR estimate in the physiological data 1490 can be a predicted iFR value with the proposed stent positioned in the vessel based on indicators 1452 and 1456. In some embodiments, corresponding indicators can be displayed at appropriate locations along the passage path 1440 of image 1410.

[0141] In some embodiments, one or more bookmarks 1454 may also be included along the ILD 1450. These bookmarks 1454 may correspond to similar bookmarks at corresponding locations along the passage path 1440 of Figure 1410.

[0142] On screen display 1400, an indicator 1470 is provided, which is superimposed on the X-ray image 1410. The indicator 1470 informs the user that the X-ray image is a zero-contrast image.

[0143] Fig. Figure 15 is a diagrammatic view of a graphical user interface 1500 according to the aspects of the present disclosure. The graphical user interface 1500 includes an extraluminal image 1510, an IVUS image 1530, and a longitudinal view 1550.

[0144] The extraluminal image 1510 can be an X-ray image. Image 1510 can be an image obtained with or without contrast medium introduced into the patient's vascular system. In some implementations, the X-ray image 1510 can show a view of the same blood vessel shown in the IVUS image 1530 and the longitudinal view 1550. Image 1510 can include an overview 1512 as well as a variety of points 1514. The overview 1512 can correspond to positions within image 1510 traversed by an IVUS imaging device. The overview 1512 can resemble any of the overviews described herein, including, for example, the overview 740 from Fig. 7 and / or the overview 840 from Fig. 8. In some implementations, a location along the overview 1512 may correspond to a location within the longitudinal view 1550. For example, a distal location 1516 along the overview 1512 may correspond to a distal location 1553 of the longitudinal view 1550. In this example, location 1516 of the radiograph 1510 and location 1556 of the longitudinal view 1550 may correspond to the same position within the patient's body lumen.

[0145] In some implementations, the multitude of points 1514 may correspond to locations where physiological measurements, such as pressure measurements, were received. For example, a point 1514 in Figure 1510 may correspond to a single location where a physiological measurement was recorded. In some embodiments, the locations of points 1514 in Figure 1510 may be aligned with the overview 1512. In other embodiments, the locations of points 1514 may not be aligned with the overview 1512. As in Fig. As shown in Figure 15, some regions of the blood vessel can be imaged by the intravascular imaging device but not measured by the physiological measuring device. In some examples, some regions of the blood vessel can be measured by the physiological measuring device but not imaged by the intravascular imaging device. Such a region can be shown, for example, by region 1518 of Figure 1510. For example, points 1514 may be present along region 1518 that correspond to physiological measurements, but the overview 1512, which corresponds to the intravascular imaging device, may not be present.

[0146] In some implementations, points 1514 of image 1510 can alternatively correspond to the locations where IVUS images were obtained. In such an implementation, line 1512 can correspond to the path of a physiological measuring device during a pullback procedure.

[0147] In some implementations, the distance between points 1514 can illustrate to a user the speed at which the device, like a physiological measuring device, has passed through the blood vessel. For example, a larger distance between adjacent points 1514 can correspond to a higher speed. Likewise, a smaller distance between adjacent points 1514 can correspond to a lower speed of the device. In some implementations, a larger distance can correspond to a slower speed and a smaller distance to a faster speed.

[0148] As in Fig. As shown in Figure 15, an indicator 1522 can identify a location along the passage path 1512 that corresponds to the IVUS image 1530. In particular, the indicator 1522 can identify the location along the passage path 1512 where the IVUS image 1530 was acquired. An additional indicator 1524 can be shown near the indicator 1522. The indicator 1524 can identify an iFR value for a user that corresponds to the same location as the indicator 1522. In some embodiments, the indicator 1524 can display any other physiological measurements. Indicators 1582 for intravascular pressure data can also be positioned in the image 1510. The indicators 1582 can correspond to the pressure measurements obtained along the length of the vessel. Indicators 1582 may also correspond to data 1592 and / or 1593 of ILD 1550 or both.In some embodiments, the indicators 1582 can illustrate pressure changes along the vessel. For example, the presence of a single indicator 1582 can correspond to a predetermined pressure change, such as a change in iFR of 0.01. Indicators 1582 can be shown in Figure 1510 next to the vessel in a line perpendicular to the vessel.

[0149] In addition, further data 1590 can be overlaid on image 1510. The data 1590 can correspond to physiological measurements acquired within the blood vessel. In some embodiments, the data 1590 can include an average value, a maximum value, a minimum value, or any other value corresponding to the physiological measurements. In some embodiments, the data 1590 can also include data corresponding to IVUS measurements. For example, the data 1590 can correspond to a vessel wall diameter or area, a lumen diameter or area, plaque load, or any other value corresponding to an IVUS image obtained at any point within the blood vessel.

[0150] The in Fig. Longitudinal view 1550 shown in Figure 15 can be an ILD. The ILD 1550 can include any features similar to those described with reference to other ILDs in the present application. For example, the ILD 1550 can be an image-based ILD or a measurement-based ILD. The ILD 1550 can include an indicator 1580. The indicator 1580 can identify the location along the ILD 1550 where the IVUS image 1530 was acquired. In this way, the indicator 1580 can correspond to the indicator 1524 of the image 1510. In some embodiments, the indicator 1580 can move to a corresponding position and display a new IVUS image when a user moves the indicator 1522 within the image 1510. If a user moves indicator 1580, indicator 1522 can also move to a corresponding position and display a new IVUS image.

[0151] In addition, a line 1592 and a line 1593 can be superimposed on the ILD 1550. Line 1593 can correspond to the raw physiological data recorded by the physiological measuring device. A line 1592 can correspond to processed physiological data recorded by the physiological measuring device. Lines 1592 and 1593 can resemble the indicators, lines, or points for physiological measurements described in the present application.

[0152] Fig. Figure 16 is a flowchart 1600 of a method for co-registering intraluminal physiological data with a longitudinal image of a body lumen according to the aspects of the present disclosure. Method 1600 can describe an automatic segmentation of a vessel to detect segments of interest by co-registering invasive physiological and radiographic images. As illustrated, Method 1600 includes a number of listed steps, but embodiments of Method 1600 may include additional steps before, after, or between the listed steps. In some embodiments, one or more of the listed steps may be omitted, performed in a different order, or performed simultaneously. The steps of Method 1600 may be performed by any suitable 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 can be performed by, or at the instruction of, a processor circuit of the diagnostic system 100, including, for example, the processor 560 (. Fig. 5) or any other component.

[0153] In step 1610, Method 1600 includes receiving a multitude of intraluminal images obtained by an intraluminal imaging device during its movement through a patient's body lumen. In some examples, the processor circuit can receive a multitude of IVUS images obtained by the IVUS imaging catheter during its movement through a patient's blood vessel.

[0154] In step 1620, method 1600 includes receiving, with the processor circuit, a variety of intraluminal physiological measurements obtained by the intraluminal physiological measuring device during its movement through the body lumen. In some embodiments, the processor circuit can receive a variety of intravascular pressure measurements obtained by the pressure-sensitive guidewire during its movement through the blood vessel.

[0155] In step 1630, method 1600 includes generating a longitudinal view of the body lumen based on the multitude of intraluminal images. In some examples, the processor circuit can generate a longitudinal view of the blood vessel based on the multitude of IVUS images.

[0156] In step 1640, method 1600 includes generating a graphical representation based on the multitude of intraluminal physiological measurements. In some examples, the processor circuit can generate a graphical representation based on the multitude of intravascular pressure measurements.

[0157] In step 1650, method 1600 includes outputting, to a display in communication with the processor circuit, a screen display comprising: the longitudinal view of the body lumen; and the graphic representation superimposed on the longitudinal view. In some embodiments, the processor circuit can output, to a display in communication with the processor circuit, a screen display comprising: the longitudinal view of the blood vessel; and the graphic representation superimposed on the longitudinal view.

[0158] Those skilled in the art will recognize that the device(s), systems, and methods described above can be modified in various ways. Accordingly, those skilled in the art will recognize that the embodiments encompassed by the present disclosure are not limited to the specific exemplary embodiments described above. In this respect, although illustrative embodiments have been shown and described, a wide range of modifications, alterations, and substitutions are considered in the preceding disclosure. It is understood that such variations can be made to the preceding without departing from the scope of protection of the present disclosure. Accordingly, it is appropriate that the accompanying claims be interpreted broadly and in a manner consistent with the present disclosure. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited patent literature

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[0127]

Claims

[1] System comprising the following: a processor circuit configured for communication with an intraluminal imaging device and an intraluminal physiological measurement device, wherein the processor circuit is configured to: Receiving a multitude of intraluminal images obtained from an intraluminal imaging device during the movement of the intraluminal imaging device through a patient's body lumen; Receiving a multitude of intraluminal physiological measurements obtained by the intraluminal physiological measuring device during the movement of the intraluminal physiological measuring device through the body lumen; Generating a longitudinal view of the body lumen based on the multitude of intraluminal images; Generating a graphical representation based on the multitude of intraluminal physiological measurements; and Output to a display in communication with the processor circuit, a screen display that includes: the longitudinal view of the body lumen; and the graphic representation that is overlaid on the longitudinal view. [2] System according to claim 1, the processor circuit is further configured to: Co-registration of the multitude of intraluminal images at the first corresponding positions along the body lumen; Co-recording the multitude of intraluminal physiological measurements at second corresponding positions along the body lumen; and the graphical representation is based on the co-registration of the multitude of intraluminal images and co-registration of the multitude of intraluminal physiological measurements overlaid on the longitudinal view. [3] System according to claim 2, wherein the graphical representation is superimposed on the longitudinal view such that a point along the graphical representation corresponds to a point along the longitudinal view, and where the location along the graphical representation and the location along the longitudinal view are representative of the same corresponding position along the body lumen. [4] System according to claim 2, the processor circuit is further configured to: Identify, based on the co-registration of the multitude of intraluminal images, a starting position of the movement of the intraluminal imaging device and a length along the body lumen that the intraluminal imaging device travels during the movement of the intraluminal imaging device; and Identifying a starting position of the movement of the physiological measuring device and a length along the body lumen that the physiological measuring device travels during the movement of the physiological measuring device; where the graphic representation is overlaid on the longitudinal view, based on: the starting position of the movement of the intraluminal imaging device; the length along the body lumen traveled by the intraluminal imaging device; the starting position of the movement of the physiological measuring device; and the length along the body lumen traveled by the physiological measuring device. [5] System according to claim 4, wherein the processor circuit is further configured to determine an offset between the start position of the movement of the intraluminal imaging device and the start position of the movement of the physiological measuring device, such that the graphical representation is overlaid on the longitudinal view, based on: the offset; the length along the body lumen traversed by the intraluminal imaging device; and the length along the body lumen traveled by the physiological measuring device. [6] System according to claim 2, the processor circuit is further configured to: Identify, based on the co-registration of the multitude of intraluminal images, a starting position of the movement of the intraluminal imaging device, and an end position of the movement of the intraluminal imaging device; and Identifying a starting position of the movement of the physiological measuring device and an end position of the movement of the intraluminal physiological measuring device; where the graphic representation is overlaid on the longitudinal view, based on: the starting position of the movement of the intraluminal imaging device; the final position of the movement of the intraluminal imaging device; the starting position of the movement of the physiological measuring device; and the end position of the movement of the intraluminal physiological measuring device. [7] System according to claim 1, wherein the graphical representation comprises a diagram based on the plurality of intraluminal physiological measurements. [8] System according to claim 7, wherein the intraluminal physiological measuring device comprises an intravascular pressure measuring device, the multitude of intraluminal physiological measurements includes a multitude of intravascular pressure measurements, wherein the processor circuit is further configured to calculate a variety of pressure ratios using the variety of intraluminal physiological measurements, and the diagram, which is based on the multitude of intraluminal physiological measurements, includes a diagram of the multitude of pressure ratios. [9] System according to claim 1, the processor circuit is configured to generate a further graphical representation based on the multitude of intraluminal physiological measurements, the screen display includes the additional graphic representation that is overlaid on the longitudinal view, the graphical representation includes a conditioned diagram based on the multitude of intraluminal physiological measurements, and the further graphical representation includes a raw diagram based on the multitude of intraluminal physiological measurements. [10] System according to claim 1, wherein the intraluminal physiological measuring device comprises an intravascular pressure measuring device, the multitude of intraluminal physiological measurements includes a multitude of intravascular pressure measurements, wherein the processor circuit is further configured to calculate a variety of pressure ratios using the variety of intraluminal physiological measurements, and the graphical representation includes a variety of forms that are representative of the amounts of change between the variety of pressure ratios. [11] System according to claim 1, wherein the processor circuit is configured to receive user input from a user device communicating with the processor circuit, selecting a section of the longitudinal view; and wherein the screen display further includes an indicator that is overlaid on the longitudinal view and identifies the section of the longitudinal view. [12] System according to claim 1, wherein the longitudinal view of the body lumen comprises an image-based longitudinal view comprising the plurality of intraluminal images. [13] System according to claim 1, wherein the processor circuit is configured to calculate a variety of measurements associated with the body lumen using the multitude of intraluminal images, and where the longitudinal view of the body lumen includes a measurement-based longitudinal view based on the multitude of measurements. [14] System according to claim 1, wherein the screen display further comprises: an extraluminal image of the body lumen; an indicator of the length traveled by the intraluminal imaging device during the movement of the intraluminal imaging device, wherein the indicator of the length traveled by the intraluminal imaging device is superimposed on the extraluminal image; and an indicator of the length traveled by the intraluminal physiological measuring device during the movement of the intraluminal imaging device, wherein the indicator of the length traveled by the intraluminal physiological measuring device is superimposed on the extraluminal image. [15] System according to claim 1, wherein the screen display further comprises: an extraluminal image of the body lumen; and one intraluminal image among the multitude of intraluminal images. [16] System comprising the following: an intravascular imaging catheter; a pressure-sensitive guide wire; and a processor circuit configured for communication with the intravascular imaging catheter and the pressure-sensitive guidewire, wherein the processor circuit is configured to: Receiving a variety of intravascular images obtained from the intravascular imaging catheter during the movement of the intravascular imaging catheter through a patient's blood vessel; Receiving a multitude of intravascular pressure measurements obtained from the pressure-sensitive guidewire during its movement through the blood vessel; Generating a longitudinal view of the blood vessel based on the multitude of intravascular images; Generating a graphical representation based on the multitude of intravascular pressure measurements; and Output to a display in communication with the processor circuit, a screen display that includes: the longitudinal view of the blood vessel; and The graphic representation is overlaid on the longitudinal view.

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