System and method for vascular image co-registration

Abstract

Methods for angiography co-registration and using co-registered imaging data to guide real-time fluoroscopy are provided. The extravascular imaging data includes an extravascular contrast image showing a portion of the blood vessel in a contrast showing a visual anatomical landmark, while the intravascular imaging data is obtained during the translation process, the intravascular imaging data including one or more intravascular images showing a detected anatomical landmark. The starting position and the ending position of the imaging element on the extravascular imaging data are marked, and a predicted position of the detected anatomical landmark on the extravascular imaging data is marked. The predicted location of the detected anatomical landmark is then aligned with the visualized anatomical landmark.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 325,349, filed on March 30, 2022, the entire contents of which are incorporated herein by reference. Technical Field

[0002] The present invention relates to medical imaging, and systems and methods for medical imaging. More particularly, the present invention relates to systems and methods for vascular imaging, including intravascular imaging and extravascular imaging and co-registration. Background Art

[0003] A wide variety of medical imaging systems and methods have been developed for medical use, such as for imaging vascular anatomy. Some of these systems and methods include intravascular imaging modes and extravascular imaging modes for imaging the vascular system. These systems and methods include various configurations and may be operated or used according to any of a variety of methods. Each of the known vascular imaging systems and methods has certain advantages and disadvantages. Therefore, there is a need to provide alternative systems and methods for vascular imaging and evaluation and co-registration of imaging. Summary of the invention

[0004] The present invention provides alternative medical imaging systems and methods. One example includes a method for determining a location of interest for performing a medical procedure. The method includes obtaining extravascular imaging data of a portion of a blood vessel, the extravascular imaging data including an extravascular image showing an intravascular imaging device disposed within the blood vessel, wherein an imaging element of the intravascular imaging device is disposed at a starting position of a translation process, and during the translation process, the imaging element translates within the blood vessel from the starting position to an ending position. An extravascular contrast image is obtained, which displays the portion of the blood vessel with contrast and displays visualized anatomical landmarks. Intravascular imaging data from the intravascular imaging device is obtained during the translation process, the intravascular imaging data including one or more intravascular images showing detected anatomical landmarks. The detected anatomical landmarks and the visualized anatomical landmarks are used to co-register the intravascular imaging data with the extravascular imaging data. A location of interest within the blood vessel between the starting position and the ending position is determined. The location of interest is displayed on a real-time fluoroscopic session display.

[0005] Another example includes a method for determining a location for performing a medical procedure. The method includes obtaining extravascular imaging data of a portion of a blood vessel, the extravascular imaging data including an extravascular image showing a start location and an end location of a translation process during which an intravascular imaging element is translated within the blood vessel from the start location to the end location. The intravascular imaging data is obtained from an intravascular imaging device during the translation process. The intravascular imaging data is co-registered with the extravascular imaging data to create co-registered imaging data. A location of interest within the portion of the blood vessel between the start location and the end location is determined using the co-registered imaging data. The location of interest is displayed on a real-time fluoroscopic session display.

[0006] Alternatively or additionally, determining the location of interest within the blood vessel between the start location and the end location may include automatically determining the location of interest based on intravascular imaging data.

[0007] Alternatively or additionally, the method may further include displaying the co-registered intravascular imaging data and extravascular imaging data.

[0008] Alternatively or additionally, locations of interest on real-time fluoroscopy may be displayed in the intravascular imaging console via a real-time data connection from the fluoroscopy machine.

[0009] Alternatively or additionally, the location of interest displayed on real-time fluoroscopy may be automatically synchronized with cardiac motion via ECC gating.

[0010] Alternatively or additionally, the location of interest displayed on the real-time fluoroscopy may be automatically synchronized with the motion analysis of a radiopaque object, such as a guide catheter or guidewire.

[0011] Alternatively or additionally, determining the location of interest within the vessel between the start location and the end location may include examining the displayed co-registered intravascular imaging data and extravascular imaging data.

[0012] Alternatively or additionally, the medical procedure may include implanting a stent.

[0013] Alternatively or additionally, displaying the location of interest on the real-time fluoroscopic display may include displaying a distal marker indicating a target location of the distal end of the stent.

[0014] Alternatively or additionally, displaying the location of interest on the real-time fluoroscopic display may further include displaying a proximal marker indicating a target location of the proximal end of the stent.

[0015] Alternatively or additionally, displaying the location of interest on the real-time fluoroscopy display may also include providing the location of interest to the real-time fluoroscopy machine via a data link with the real-time fluoroscopy display.

[0016] Alternatively or additionally, the data link may comprise a bidirectional data link.

[0017] Alternatively or additionally, the method may further include transmitting data from the real-time fluoroscopic display to a display that displays the co-registered intravascular imaging data and the extravascular imaging data.

[0018] Alternatively or additionally, the data link may include the Internet.

[0019] Alternatively or additionally, the extravascular imaging data may include one or both of angiographic image data and fluoroscopic image data.

[0020] Alternatively or additionally, the intravascular imaging data may include one or more of intravascular ultrasound data and optical coherence tomography data.

[0021] Alternatively or additionally, the translation process may be a pullback.

[0022] Another example includes a method for determining a location of interest for performing a medical procedure. The method includes obtaining extravascular imaging data of a portion of a blood vessel and obtaining intravascular imaging data for the same portion of the blood vessel. Co-registering the intravascular imaging data with the extravascular imaging data. Determining a location of interest for performing a medical procedure and displaying the location of interest on a real-time fluoroscopic session display.

[0023] Alternatively or additionally, the medical procedure may include implanting a stent.

[0024] Alternatively or additionally, displaying the location of interest on the real-time fluoroscopic display may include displaying a distal marker indicating a target location of the distal end of the stent.

[0025] Alternatively or additionally, displaying the location of interest on the real-time fluoroscopic display may further include displaying a proximal marker indicating a target location of the proximal end of the stent.

[0026] Another example includes a method for determining a location of interest for implanting a stent. The method includes obtaining extravascular imaging data of a portion of a blood vessel and obtaining intravascular imaging data for the same portion of the blood vessel. Co-registering the intravascular imaging data with the extravascular imaging data. Determining a desired implant location for implanting the stent and displaying it on a real-time fluoroscopic session display.

[0027] Alternatively or additionally, displaying the desired stent implantation position may include displaying one or more of a distal marker indicating a target position of a distal end of the stent and a proximal marker indicating a target position of a proximal end of the stent.

[0028] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present invention. The following figures and detailed description more particularly exemplify these embodiments. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The present invention may be more fully understood by considering the following detailed description taken in conjunction with the accompanying drawings, in which:

[0030] Figure 1 is a schematic diagram of an exemplary system for vascular imaging co-registration;

[0031] Figure 2 is a schematic diagram of an exemplary intravascular imaging catheter shown in partial cross-sectional view;

[0032] Figure 3 Shown in cross section Figure 2 A schematic diagram of a distal portion of an exemplary intravascular imaging catheter;

[0033] Figure 4 is a schematic diagram of a display showing an example extravascular image;

[0034] Figure 5 is a schematic diagram showing a display of an example extravascular contrast image;

[0035] Figure 6 is a schematic diagram of a display showing an example extravascular image and showing corresponding intravascular imaging including transverse cross-sectional and longitudinal cross-sectional images obtained during a beginning portion of a translation process;

[0036] Figure 7 is a schematic diagram of a display showing an example extravascular image and showing corresponding intravascular imaging including transverse cross-sectional and longitudinal cross-sectional images obtained during an intermediate portion of a translation process;

[0037] Figure 8 is a schematic diagram of a display showing an example extravascular image and showing corresponding intravascular imaging including transverse cross-sectional and longitudinal cross-sectional images obtained during an ending portion of a translation process;

[0038] Fig. 9 is a schematic diagram of a display showing an example combined extravascular image with start and end positions of a translation process marked and showing corresponding intravascular imaging including transverse cross-sectional and longitudinal cross-sectional images;

[0039] Fig.10 is a schematic diagram of a display showing an example extravascular image including predicted locations of detected anatomical landmarks of a marker and showing corresponding intravascular imaging including transverse cross-sectional and longitudinal cross-sectional images;

[0040] Fig.11 The predicted position of the detected anatomical landmark of the marker is displayed in alignment with the visualized anatomical landmark and the corresponding intravascular imaging including transverse cross-sectional and longitudinal cross-sectional images is displayed. Fig.10 A schematic diagram of the display shown;

[0041] Fig.12 is a schematic diagram of a display showing an example extravascular image including a predicted position of a marked second detected anatomical landmark and showing corresponding intravascular imaging including transverse cross-sectional and longitudinal cross-sectional images;

[0042] Fig.13 is to display the predicted position of the second detected anatomical landmark of the marker aligned with the second visualized anatomical landmark and display the corresponding intravascular imaging including the transverse cross-sectional image and the longitudinal cross-sectional image. Fig.12 A schematic diagram of the display shown;

[0043] Fig.14 is a schematic diagram of a display showing an example extravascular image including a predicted position of a marked third detected anatomical landmark and showing corresponding intravascular imaging including transverse cross-sectional and longitudinal cross-sectional images;

[0044] Fig.15 is to display the predicted position of the third detected anatomical landmark of the marker aligned with the third visualized anatomical landmark and display the corresponding intravascular imaging including the transverse cross-sectional image and the longitudinal cross-sectional image. Fig.14 A schematic diagram of the display shown;

[0045] Fig.16 is a schematic diagram of a display showing an example extravascular image including a marker predicted position of a fourth detected anatomical landmark and showing corresponding intravascular imaging including transverse cross-sectional and longitudinal cross-sectional images;

[0046] Fig.17 is to display the marker predicted position of the fourth detected anatomical landmark aligned with the fourth visualized anatomical landmark and display the corresponding intravascular imaging including the transverse cross-sectional image and the longitudinal cross-sectional image. Fig.16 A schematic diagram of the display shown;

[0047] Fig.18 is a schematic diagram of a display showing co-registered images including an example extravascular image and showing corresponding intravascular imaging including transverse cross-sectional and longitudinal cross-sectional images;

[0048] Fig.19 is a schematic diagram of an exemplary catheterization laboratory;

[0049] Fig. 20 is an exemplary real-time fluoroscopic image;

[0050] Fig.21 is an exemplary real-time fluoroscopic image;

[0051] Fig. 22 is a schematic diagram of a display showing an exemplary real-time fluoroscopic image and showing corresponding intravascular imaging including transverse cross-sectional and longitudinal cross-sectional images; and

[0052] Fig.23 is a schematic diagram of a display including co-registered images of example extravascular images and including a display schematically showing corresponding intravascular imaging of transverse and longitudinal cross-sectional images combined with an interactive slider mechanism.

[0053] Although the present invention is suitable for various modifications and alternative forms, its specific details have been shown in the drawings by way of example and will be described in more detail. However, it should be understood that it is not intended to limit the present invention to the specific embodiments described. On the contrary, it is intended to cover all modifications, equivalents and substitutes that fall within the spirit and scope of the present invention. DETAILED DESCRIPTION

[0054] For the following defined terms, these definitions shall apply unless a different definition is given in the claims or elsewhere in this specification.

[0055] All numerical values ​​are assumed herein to be modified by the term "about", whether or not expressly indicated. The term "about" generally refers to a range of numbers that one skilled in the art considers to be equivalent to the referenced value (i.e., having the same function or result). In many cases, the term "about" may include numbers that are rounded to the nearest significant figure.

[0056] The recitation of numerical ranges by endpoints includes all numbers within that range (eg, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0057] As used in this specification and the appended claims, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification and the appended claims, the term "or" is generally employed in its inclusive sense unless the content clearly dictates otherwise.

[0058] It should be noted that references in the specification to "one embodiment", "some embodiments", "other embodiments", etc. indicate that the described embodiments may include one or more specific features, structures, or characteristics. However, such a description does not necessarily mean that all embodiments include the specific features, structures, or characteristics. Additionally, when a specific feature, structure, or characteristic is described in conjunction with one embodiment, it should be understood that such feature, structure, or characteristic may also be used in conjunction with other embodiments, whether or not explicitly described, unless explicitly stated to the contrary.

[0059] The following detailed description should be read with reference to the drawings, in which similar elements in different drawings have the same reference numerals. The drawings, which are not necessarily drawn to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0060] Many different medical imaging modalities can be used to evaluate or treat blood vessels. Two general types of imaging modalities include extravascular imaging modalities and intravascular imaging modalities. The present invention relates to the use and co-registration of these modalities.

[0061] Extravascular imaging modalities, such as various forms of radiographic imaging, provide extravascular imaging data of a portion of a vessel. Some examples include angiography or fluoroscopy modalities, such as two-dimensional angiography / fluoroscopy; three-dimensional angiography / fluoroscopy; or computed tomography angiography / fluoroscopy. Angiography typically involves rendering a radiographic view of one or more blood vessels, typically using a radiopaque contrast agent. Angiographic images can also be viewed in real time via fluoroscopy. Typically, fluoroscopy uses less radiation than angiography and is often used to guide medical devices, including radiopaque markers, within or through a blood vessel. Extravascular imaging data of a blood vessel can provide useful information about the location or positioning of a blood vessel, an anatomical structure, or a device within a blood vessel or anatomical structure. For example, extravascular imaging data (e.g., angiograms) can provide a comprehensive overall image or a series of images or videos of a blood vessel of interest, and can provide a "roadmap" with good temporal resolution for overall assessment of the blood vessel or navigation of a device within the blood vessel.

[0062] The intravascular imaging mode provides intravascular imaging data of a portion of a blood vessel. Some examples of intravascular imaging modes include intravascular ultrasound (IVUS) and optical coherence tomography (OCT). These modes generally include imaging the blood vessel itself using an intravascular probe mounted on a device, which includes an imaging element disposed within the blood vessel. Several types of device systems have been designed to track through the vascular system to provide intravascular image data. These may include, but are not limited to, intravascular ultrasound (IVUS) devices and optical coherence tomography (OCT) devices (e.g., catheters, guidewires, etc.). In operation, a probe including an imaging element mounted on an intravascular device moves along the blood vessel in the area where imaging is required. When the probe passes through the area of ​​interest, an intravascular image data set is obtained, which corresponds to a series of "slices" or cross-sections of the blood vessel, cavity, and surrounding tissue. These devices may include radiopaque materials or markers. These markers are typically positioned near the distal tip or near or on the probe. Therefore, the approximate position of the imaging probe or imaging element can be discerned by observing the surgery on a fluoroscopic or angiographic image. Typically, such imaging devices are connected to a dedicated processing unit or control module, including processing hardware and software and a display. Raw image data is received by a console, processed to render an image including features of interest and rendered on a display device. Intravascular imaging data of a vessel can provide useful information about the vessel that is different from or in addition to the information provided by extravascular imaging data. For example, intravascular imaging data can provide data regarding the cross-section of the lumen, the thickness of deposits on the vessel wall, the diameter of the non-lesioned portion of the vessel, the length of the diseased segment, the composition of deposits or plaques on the vessel wall, plaque burden assessment, or stent deployment assessment.

[0063] These two general types of imaging modes provide different imaging data and can therefore complement each other. Therefore, in some cases, it may be desirable to provide or use these two general types of medical imaging modes to evaluate or treat blood vessels. Additionally, it may be useful to associate the location of the acquired intravascular imaging data / image with its location on a vascular roadmap obtained from the extravascular imaging data / image. It may be useful to coordinate or "register" (e.g., co-register) imaging data rendered by two different modes. It may also be useful to display the co-registered extravascular imaging data and intravascular imaging data together, such as on a common display monitor. Some example embodiments disclosed herein may include or relate to some or all of these aspects.

[0064] According to some embodiments of the present invention, example methods, systems, devices or software are described herein. These examples include image data acquisition devices and data / image processors and associated software for obtaining and registering (e.g., co-registering) imaging data rendered by two different imaging modes (e.g., extravascular imaging data and intravascular imaging data). Additionally or alternatively, the example methods, systems or software can generate a view on a single display that simultaneously provides an extravascular image with position information and an intravascular image associated with an imaging probe (e.g., an IVUS or OCT probe) mounted on an intravascular device.

[0065] Figure 1 1 is a schematic depiction of an exemplary system 102 that may be used in conjunction with performing embodiments of the present invention by acquiring and co-registering extravascular image data (e.g., angiography / fluoroscopy) and intravascular image data (e.g., IVUS or OCT images). The system 102 may include an extravascular imaging system / subsystem 104 (e.g., angiography / fluoroscopy system) for acquiring / generating extravascular imaging data. The system 102 may also include an intravascular imaging system / subsystem 106 (e.g., IVUS or OCT) for acquiring / generating intravascular imaging data. The system 102 may include a computer system / subsystem 130 including one or more controllers or processors, memory, and / or software configured to perform a method for vascular imaging registration of acquired extravascular imaging data and acquired intravascular imaging data.

[0066] The extravascular imaging data may be radiographic image data obtained by an angiography / fluoroscopy system 104. Such angiography / fluoroscopy systems are generally well known in the art. The angiography / fluoroscopy system 104 may include an angiography table 110, which may be arranged to provide sufficient space to position an angiography / fluoroscopy unit C-arm 114 in an operating position relative to a patient 100 on the table 110. The raw radiographic image data acquired by the angiography / fluoroscopy C-arm 114 may be transmitted to an extravascular data input port 118 via a transmission cable 116. The input port 118 may be a separate component, or may be integrated into or may be a part of the computer system / subsystem 130. The angiography / fluoroscopy input port 118 may include a processor that converts the raw radiographic image data received therefrom into extravascular image data (e.g., angiography / fluoroscopy image data), for example, in the form of real-time video, DICOM, or a series of individual images. The extravascular image data may initially be stored in a memory within the input port 118, or may be stored within the computer 130. If the input port 118 is a separate component from the computer 130, the extravascular image data may be transferred to the computer 130 via the cable 117 and into the input port in the computer 130. In some alternatives, communication between the devices or processors may be via wireless communication rather than by cables.

[0067] The intravascular imaging data can be, for example, IVUS data or OCT data obtained by an intravascular imaging system / subsystem 106 (e.g., an IVUS or OCT system). Such IVUS and OCT systems are generally well known in the art. The intravascular subsystem 106 can include an intravascular imaging device, such as an imaging catheter 120, for example, an IVUS or OCT catheter. The imaging device 120 is configured to be inserted into the patient 100 so that its distal end (including a diagnostic component or probe 122, (e.g., an IVUS or OCT probe)) is located near the desired imaging location of the blood vessel. A radiopaque material or marker 123 located on or near the probe 122 can provide an indication of the current position of the probe 122 in the radiographic image.

[0068] For example, in the case of IVUS intravascular imaging data, the diagnostic probe 122 generates ultrasound waves and receives ultrasound echoes representing the area near the diagnostic probe 122. The probe 122 or the catheter 120 can convert the ultrasound echoes into corresponding signals, such as electrical signals or optical signals. The corresponding signal is transmitted to the proximal connector 124 along the length of the imaging catheter 120. The proximal connector 124 of the catheter 120 is communicatively connected to the processing unit or control module 126. The IVUS version of the probe 122 has a variety of configurations, including single transducer element and multi-transducer element configurations. It should be understood that in the context of IVUS, the transducer can be regarded as an imaging element. In the case of a multi-transducer element arrangement, the transducer array may be arranged as follows: linearly arranged along the longitudinal axis of the imaging catheter 120, curvedly arranged around the longitudinal axis of the catheter 120, circumferentially arranged around the longitudinal axis, etc.

[0069] exist Figure 2 and Figure 3 An example of an IVUS intravascular imaging catheter 120 is shown in FIG. The imaging catheter 120 may include an elongated shaft 170 having a proximal region 172 and a distal region 174. A proximal hub or connector 124 may be coupled to the proximal region 172 or otherwise disposed adjacent thereto. A tip member 176 may be coupled to the distal region 174 or otherwise disposed adjacent thereto. The tip member 176 may include a guidewire lumen, an atraumatic distal end, one or more radiopaque markers, or other features. An imaging assembly 177 may be disposed within the shaft 170. Typically, the imaging assembly 177 (which may include an imaging probe 122, which includes an imaging element 182) may be used to capture / generate images of a blood vessel. In some cases, the medical device may include devices or features similar to those disclosed in U.S. Patent Application Publication No. US2012 / 0059241 and U.S. Patent Application Publication No. US2017 / 0164925, the entire disclosures of which are incorporated herein by reference. In at least some cases, the medical device 120 can be similar to the OPTICROSS available from Boston Scientific of Marlborough, Massachusetts. TM An imaging catheter may include features similar thereto.

[0070] like Figure 3As shown, the imaging assembly 177 can include a drive cable or shaft 178, an imaging probe 122 including a housing 180, and an imaging element or transducer 182. The imaging probe 122 or housing 180 can be coupled to the drive cable 178. The transducer 182 can rotate or translate axially relative to the shaft 170. For example, the drive cable 178 can rotate or translate to rotate or translate the transducer 182. For example, the probe 122 or housing 180 can include or be made of a radiopaque material or marker 123 that can provide an indication of the current position of the probe 122 in the radiographic image.

[0071] Return to reference Figure 1 By way of another example, the device 120 may be an OCT catheter for collecting OCT intravascular data. The OTC catheter 120 may include a diagnostic probe 122 that generates or propagates a beam of light directed toward the tissue and collects a portion of the light reflected from a subsurface feature, and the portion of the light represents an area immediately adjacent to the diagnostic probe 122. In OCT, the diagnostic probe 122 will include an optical imager for delivering and collecting light. It should be understood that in the context of OCT, the optical imager in the probe 122 may be considered an imaging element. A technique called interferometry may be used to record the length of the optical path of the received photons, allowing most of the photons that are scattered multiple times before detection to be rejected. Thus, OCT may establish an image of a thick sample by rejecting background signals while collecting light directly reflected from the surface of interest. The probe 122 or catheter 120 may transmit an optical or light signal along an axis, or may convert an optical signal into a corresponding signal, such as an electrical or optical signal, which may be transmitted along the length of the imaging catheter 120 to a proximal connector 124. The proximal connector 124 of the catheter 120 is communicatively connected to a processing unit or control module 126. The probe 122 or housing 180 may include or be made of radiopaque material or markings 123 that may provide an indication of the current position of the probe 122 in the radiological image.

[0072] Raw intravascular image data (e.g., raw IVUS or OCT data) can be acquired by the imaging catheter 120 and can be transferred to the control module 126, for example, via the connector 124. The control module 126 can be a separate component, or can be integrated into or become part of the computer system / subsystem 130. The control module 126 can include a processor that converts or is configured to convert the raw intravascular image data received via the catheter 120 into intravascular image data (e.g., IVUS or OCT image data), for example, in the form of real-time video, DICOM, or a series of individual images. The intravascular imaging data can include transverse cross-sectional images of the vessel segment. Additionally, the intravascular imaging data can also include longitudinal cross-sectional images corresponding to the vessel slices taken along the length of the vessel. The control module 126 can be viewed as an input port of the computer system / subsystem 130, or can also be viewed as an input port connected to the computer 130, for example, via the cable 119 or a wireless connection. The intravascular image data can initially be stored in a memory within the control module 126, or can be stored in a memory of the computer system / subsystem 130. If the control module 126 is a separate component from the computer system / subsystem 130, the intravascular image data may be transferred to the computer 130, for example, via the cable 119, and into an input port in the computer 130. Alternatively, communication between the devices or processors may be via wireless communication rather than via the cable 119.

[0073] The control module 126 may also include one or more components that may be configured to operate the imaging device 120 or control the collection of intravascular imaging data. For example, in the case of an IVUS system, the control module 126 may include one or more of a processor, a memory, a pulse generator, a motor drive unit, or a display. As another example, in the case of an OCT system, the control module 126 may include one or more of a processor, a memory, a light source, an interferometer, an optical device, a motor drive unit, or a display. In some cases, the control module 126 may be or include a motor drive unit that is configured to control the movement of the imaging catheter 120. Such a motor drive unit may control the rotation or translation of the imaging catheter 120 or its components. In some cases, the control module 126 or the motor drive unit may include an automatic translation system that may be configured to translate the imaging catheter 120 in a controlled / measured manner within the patient 100. Such an automatic translation system may be used so that during the translation process, the imaging catheter 120 (including the imaging element) translates from a starting position to an ending position within the blood vessel at a constant or known speed. (e.g., the imaging catheter 120 is translated at a specific rate over a known amount of time). In other embodiments, the translation can be done manually. For example, the translation process can be a "pull-back" process (where the catheter 120 is pulled through the vessel) or a "push-through" process (where the catheter 120 is pushed through the vessel). The control module 126 can also be configured by hardware and software, or include hardware and software, which is configured to control intravascular imaging and data collection. For example, the control module 126 can include control features for turning on / off imaging or data collection from / to the catheter 120.

[0074] The computer system / subsystem 130 may include one or more controllers or processors, one or more memories, one or more input ports, one or more output ports, and / or one or more user interfaces. The computer 130 obtains intravascular image data from or through the intravascular imaging system / subsystem 106 (e.g., IVUS or OCT), and obtains extravascular image data from or through the extravascular imaging system / subsystem 104 (e.g., angiography / fluoroscopy system). The computer 130 or its components may include software and hardware designed to be integrated into a standard catheter examination process and automatically acquire both extravascular imaging data (e.g., angiography / fluoroscopy) and intravascular imaging data (e.g., IVUS or OCT) through image or video acquisition.

[0075] The computer system / subsystem 130 or a component thereof may include software or hardware configured to perform a method for vascular imaging co-registration of the obtained extravascular imaging data and the obtained intravascular imaging data. In this context, the computer 130 may include computer-readable instructions or software to perform a method for vascular imaging co-registration as disclosed herein. For example, in some aspects, a computer may include a processor or a memory, which includes software, the software including program code, the program code causing the computer to perform a method for vascular imaging co-registration as disclosed herein. For example, a computer / computing device may include a processor or a memory, which includes instructions, the instructions being executable by the processor to perform a method for vascular imaging co-registration as disclosed herein. In this context, it should also be understood that a computer-readable medium having program code stored thereon in a non-transitory state for use by the computer / computing device 130 is also disclosed herein, the program code causing the computing device 130 to perform a method for vascular imaging co-registration as disclosed herein. Additionally, the computer / computing device 130 can be part of or include a system for intravascular imaging registration, the system comprising one or more input ports for receiving imaging data; one or more output ports; and a controller in communication with the input ports and the output ports, the controller being configured to perform a method for intravascular imaging registration as disclosed herein.

[0076] The computer system / subsystem 130 may also include software and hardware configured to render or display imaging, including, for example, extravascular imaging or intravascular imaging obtained from the received image data or co-registration method. In some cases, the computer 130 or the software may be configured to render both extravascular imaging and intravascular imaging on a single display. In this regard, the system may include a display 150 configured to simultaneously display extravascular image data and intravascular image data rendered by the computer 130. The display 150 may be part of the computer system 130, or may be a separate component that communicates with the computer system 130, the communication being achieved, for example, through an output port on the computer 130 and a transmission cable 121. However, in some other cases, the communication through the output port may be wireless, rather than through a cable. In some examples, the computer 130 or the display screen 150 may be configured to simultaneously provide angiograms, IVUS transverse plane views, and IVUS longitudinal plane views, which may or may not all be co-registered. In other examples, the display may be configured to simultaneously provide an angiogram, an OCT transverse plane view, and an OCT longitudinal plane view, which may or may not be co-registered.

[0077] The computer system / subsystem 130 may also include one or more additional output ports for transferring data to other devices. For example, the computer may include an output port for transferring data to a data archive or memory 131. The computer system / subsystem 130 may also include a user interface, which may include software and hardware configured to allow an operator to use or interact with the system.

[0078] The components of system 102 can be used in conjunction during a vascular imaging method or procedure that involves collecting extravascular imaging data and intravascular imaging data during a translational process. Where the procedure is performed and the desired imaging data is obtained, an example method for intravascular imaging registration can be performed or implemented.

[0079] For example, the patient 100 can be arranged on a workbench 110 for extravascular imaging of a portion of a vessel of interest. The patient 100 or the workbench can be arranged or adjusted to provide a desired view of the vessel of interest in preparation for collecting extravascular imaging data. Additionally, an intravascular imaging catheter 120 can be introduced intravascularly into a portion of the vessel of interest in preparation for a translation process for collecting intravascular imaging data. The intravascular imaging catheter 120 can be navigated and positioned intravascularly (usually under fluoroscopy) so that the imaging element is located at the starting position required for the translation process. A guide catheter can be used to assist in navigation. Once in the appropriate position, the translation process can be performed or implemented. Before or during the translation process, the desired extravascular and intravascular imaging data can be obtained. In this context or as part of the process, an example method for co-registration or registration of vascular imaging can be performed or implemented.

[0080] Acquisition of extravascular imaging data

[0081] One aspect of an example method for vascular imaging co-registration includes obtaining extravascular imaging data of a portion of a blood vessel. A component of the obtained extravascular imaging data includes an extravascular image showing an intravascular imaging device disposed within the blood vessel. This may be performed by Figure 4 express, Figure 4An angiographic / fluoroscopic image 151 generated by the angiographic / fluoroscopic system 104 and obtained by the computer 130 and displayed on the image output 153 in the upper left portion of the display 150 is shown. The image 151 may be part of a video stream or series of images displayed on the screen of the display 150 at the image output 153. The individually rendered frames may be appropriately labeled (e.g., frame number, time stamp, sequence number, etc.), which may be useful for associating the image data frames. As shown, the acquired imaging data may include an extravascular image 151, which shows an intravascular imaging device 120 disposed within a blood vessel 10 (the blood vessel is shown in dashed lines), wherein an imaging element 182 of the intravascular imaging device 120 is disposed at the starting position 20 of the translation process. (e.g., sometimes referred to as an "extravascular device image 151"). The extravascular device image 151 may be obtained and recorded under fluoroscopy, through which the radiopaque markers 123 on the device 120 may be used to locate / visualize the position of the imaging element 182 or the starting position 20 of the imaging element 182. Since the starting position 20 has been determined by identifying the actual position from the extravascular image 151, it is an image showing the actual / known position of the intravascular imaging device 120 disposed within the blood vessel 10 at a particular time and may be useful during registration. As can be appreciated, the image 151 may be obtained without contrast (e.g., under fluoroscopy), and therefore, the anatomical structure of the blood vessel 10 may be difficult to discern / visualize (which is also why it is shown in dashed lines).

[0082] During the translation process, the imaging element 182 will translate from the starting position 20 to the ending position 30 within the blood vessel 10. The extravascular image 151 may also display the ending position 30 of the translation process. For example, as indicated above, a guide catheter 190 including a distal end 191 may be used during the process. The distal end 191 may include a radiopaque material or a marker and may be visualized or displayed on the obtained extravascular image 151 and used as the ending position of the translation process. Since the ending position 30 has been determined by identifying the actual position based on the obtained angiographic / fluoroscopic image 151, it is also an actual / known position within the blood vessel 10 and may also be useful during registration. In other embodiments, other reference points displayed on the extravascular image 151 may be used to define the starting or ending position. For example, other devices, stents, anatomical markers, etc. displayed on the extravascular image 151 may be used.

[0083] The acquired extravascular imaging data may also include an extravascular contrast image that displays a portion of a blood vessel with contrast and displays one or more visualized anatomical landmarks. Figure 5 express, Figure 5An extravascular contrast image 251 (e.g., an angiogram taken with contrast agent within the blood vessel 10) generated by the angiography / fluoroscopy system 104 and obtained by the computer 130 and displayed on the display 150 at the image output 153 is shown. The image 251 may be part of the same video stream or series of images as the device image 151 and displayed on the screen of the display at the image output 153. As shown, the obtained data may include an extravascular contrast image 251 that displays a portion of the blood vessel 10 with contrast and displays one or more visualized anatomical landmarks (e.g., blood vessel side branches 12, 14, 16, 18). Although in this example, the one or more visualized landmarks include blood vessel side branches 12, 14, 16, 18, other anatomical landmarks are also contemplated and may be displayed / used. Some examples of other visualized anatomical landmarks that may be displayed / used may include: stents, identifiable changes in the size or shape of the blood vessel 10, such as curves, narrowing, widening, etc., or other identifiable anatomical landmarks that may be visualized on the extravascular contrast image 251.

[0084] The extravascular imaging data obtained may include video data including an extravascular device image 151 (e.g., an image showing the starting position of the intravascular imaging device 120), and an extravascular contrast image 251 (e.g., a "road map"). In some cases, the extravascular device image 151 and the extravascular contrast image 251 may be separate individual images that may be combined or superimposed. These images may be obtained automatically by the system as part of a procedure that may be initiated by a user, or may be manually requested or obtained by a user interacting with the system (e.g., through a user interface).

[0085] The order in which the extravascular imaging data are acquired may also be different. Figure 4 and Figure 5 In the illustrated embodiment of FIG. 1 , the imaging device 120 may first be navigated to a desired starting position and an extravascular device image 151 (eg, Figure 4 ). Afterwards, an extravascular angiography image 251 (eg, Figure 5), wherein when the angiography image 251 is taken, the imaging device 120 is already located or is still located in the blood vessel 10. In other embodiments, it is contemplated that the order may be reversed. For example, the extravascular angiography image 251 may be first obtained without an intravascular imaging device in the blood vessel 10. Thereafter, the imaging device 120 may be navigated to a desired starting position, and an extravascular device image 151 of the device 120 displayed in the starting position may be obtained. As may be appreciated, the extravascular imaging data may include one or both of angiography image data and fluoroscopic image data. Additionally, as disclosed herein, the extravascular imaging data may be selected from one or more of two-dimensional angiography image data; three-dimensional angiography image data; or computed tomography angiography image data.

[0086] Obtaining intravascular imaging data

[0087] Another aspect of an example method for vascular imaging co-registration includes obtaining intravascular imaging data from an intravascular imaging device during the translation process, the intravascular imaging data including one or more intravascular images showing one or more detected anatomical landmarks. An example of this can be referenced to Figures 6 to 8 A representation / description is made of a series of graphs, each of which displays intravascular imaging data represented by a video or a series of intravascular images obtained during the progress of a translation process. The system may include software configured to initiate or implement or facilitate the translation process. The translation process can be initiated by a user interacting with the system, for example, through a user interface (e.g., clicking a "start pullback process" button to start translation). Additionally, the translation process can be performed using an automated pullback system, for example, at a known speed, as discussed herein.

[0088] In this example, the translation process is a pullback, wherein the imaging element 182 is translated from a starting position 20 to an ending position 30 within the vessel. As can be appreciated, in this example, the intravascular imaging data is intravascular ultrasound data (IVUS). However, as discussed above, in other embodiments, the intravascular imaging data may be generated using other intravascular modalities, such as optical coherence tomography (OCT), etc. The acquired intravascular imaging data in the form of a video or a series of images will include one or more intravascular images showing one or more detected anatomical landmarks in the progress of the translation process. The individually rendered intravascular image frames may be appropriately labeled (e.g., frame number, pullback distance, timestamp, sequence number, etc.), which may be useful to help associate image data frames, for example, associating an intravascular image frame with a corresponding extravascular (e.g., radiopaque marker) image data frame or associating a longitudinal cross-sectional intravascular image with a transverse cross-sectional intravascular image. As will be seen, in this example, the detected anatomical landmarks detected on IVUS include four side branches, which are displayed in the angiogram of that portion of the vessel (e.g., in Figure 5 14, 16, 18 on the angiogram in FIG. 1 ). However, other detected anatomical landmarks are also contemplated and may be displayed / used. Some examples of other detected anatomical landmarks that may be used include: stents, identifiable changes in the size or shape of the vessel 10, such as curves, narrowing, widening, etc., or other detectable anatomical landmarks that may be detected using one or more intravascular images obtained during the translation process.

[0089] Figures 6 to 8 Each of the displays 150 displays an on-screen image output 154 in the lower portion of the display 150 that includes intravascular imaging data that includes / represents a series of images generated by the intravascular imaging system / subsystem 106, obtained by the computer 130, and displayed on the display 150. As can be appreciated, the intravascular images displayed in the image output 154 may include a plurality of longitudinal cross-sectional images that correspond to vessel slices taken along the length of the vessel during the translation process. The intravascular images displayed in the image output 154 are obtained during the translation process and may be recorded as part of a video or series of intravascular images. As the translation process progresses, the intravascular imaging data displayed in the image output 154 may be progressively populated with additional intravascular images as they are generated. This may be accomplished, for example, by viewing the intravascular images of the image output 154. Figures 6 to 8 154, wherein as the panning process progresses, additional intravascular images are progressively added to the intravascular imaging data 154 on the display 150. One or more of these intravascular images will display one or more detected anatomical landmarks (as discussed in further detail herein).

[0090] Additionally, Figures 6 to 8 Each of the image outputs 152 displayed on the screen at the upper right portion of the display 150 includes intravascular imaging data including / representing a series of transverse cross-sectional images of a vessel segment. These transverse cross-sectional images are included in the imaging data generated by the intravascular imaging system / subsystem 106 and obtained by the computer 130 and displayed at the image output 152 on the display 150. These transverse cross-sectional intravascular images displayed in the image output 152 are acquired stepwise during the panning process and may be part of or recorded as an intravascular imaging video or series of intravascular images. At any particular point in time during the panning process, the transverse cross-sectional image displayed in the image output 152 may correspond to the longitudinal cross-sectional image that was last added to the intravascular imaging output 154. In other words, a particular transverse cross-sectional image displayed in the image output 152 and the corresponding longitudinal cross-sectional image simultaneously added at the end of the image output 154 may be different cross-sectional intravascular images / views, but taken at the same time / position in the vessel.

[0091] During the translation process, intermediate extravascular imaging data may also be optionally / periodically obtained, for example, to track the actual progress of the intravascular imaging device 120 during the translation process. These intermediate extravascular images may be obtained during the translation process and may show the actual / known position of the intravascular imaging device 120 disposed within the blood vessel 10, wherein the imaging element is disposed at an intermediate position between the start position 20 and the end position 30 during the translation process. For example, during the translation process, the angiography / fluoroscopy system 104 may be periodically manually or automatically activated (e.g., fluoroscopy may be activated) to generate one or more intermediate angiography / fluoroscopy images, which are obtained by the computer 130 and displayed in the image output 153 on the display 150 at this time. In at least some embodiments, the translation process or the collection or co-registration method of the intravascular images may be performed without continuous angiography / fluoroscopy. In other words, the angiography / fluoroscopy system 104 may be periodically activated, but a significant portion or period of the translation may also be performed without activated angiography / fluoroscopy. In such an embodiment, the actual / known position of the intravascular imaging device 120 is not continuously tracked under angiography / fluoroscopy during the translation process.

[0092] Figures 6 to 8Each of the images will display such an intermediate / periodically acquired extravascular image in the upper left portion of the image output 153 on the display 150. It will be appreciated that such an intermediate extravascular image will display the imaging element 182 positioned at an actual / known intermediate position within the blood vessel 10 at a particular time during the translation process. At a particular point in time during the translation process when the intermediate extravascular image is generated and shown in the image output 153 on the display 150, the corresponding longitudinal cross-sectional image of that particular intermediate position within the blood vessel will be displayed as the last image added in the intravascular imaging output 153. Likewise, the transverse cross-sectional image displayed in the image output 152 at this time will also correspond to the particular intermediate position within the blood vessel 10.

[0093] A brief review Figures 6 to 8 progress, Figure 6 Intravascular images taken near the beginning of the translation process are displayed. Due to the early stage of the translation process, the image output 154 at the bottom of the screen is relatively short, showing relatively few longitudinal cross-sectional intravascular images acquired so far during the translation process. In the upper right portion of the display 150, the image output 152 shows the corresponding intravascular transverse cross-sectional image 252 of the vessel at that location. Figure 6 Also shown is an intermediate extravascular image 351 in the image output 153 on the display 150. The intermediate extravascular image 351 may be obtained by briefly activating the fluoroscope to discern the actual / known position of the intravascular imaging device 120 at this time during the translation process, which in this case shows the imaging element being positioned closer to the starting position 20 than the ending position 30.

[0094] Figure 7 An intravascular image captured near the middle of the panning process is shown. The image output 154 at the bottom of the screen is growing (with Figure 6 ), which shows the addition of more longitudinal cross-sectional intravascular images acquired as the translation process progresses. It will also be appreciated that one or more of these intravascular images will display one or more detected anatomical landmarks. In this case, the detected anatomical landmarks are detected side branches of the vessel 10. Figure 7, these intravascular images showing the first two side branches (e.g., detected anatomical landmarks) are marked with lines 197 and 198. In some cases, the detected anatomical landmarks can be automatically detected or marked by the system. For example, computer 130 may include software or hardware configured to perform image processing and image recognition. Using intravascular image data (e.g., IVUS data or other suitable data), the system can perform image processing and image recognition to identify or mark images including detected anatomical landmarks 197 / 198. In other cases, images including detected anatomical landmarks can be manually identified or marked by a user, such as through a user interface.

[0095] exist Figure 7 In the upper right portion of the display 150 , the image output 152 displays a corresponding intravascular transverse cross-sectional image 352 of the blood vessel at the location. Figure 7 Also shown is a second intermediate extravascular image 451 in the image output 153 on the display 150. The intermediate extravascular image 451 may be obtained by briefly activating the fluoroscope to discern the actual / known position of the intravascular imaging device 120 at this time during the translation process, which in this case shows the imaging element positioned approximately halfway between the starting position 20 and the ending position 30.

[0096] Figure 8 The intravascular image captured when the panning process is nearing completion or has been completed is displayed. The image output 154 at the bottom of the screen has grown across the display (with Figure 6 and Figure 7 ), which shows the addition of more longitudinal cross-sectional intravascular images obtained through the complete translation process (from start to finish). It will also be appreciated that one or more of these intravascular images in the image output 154 on the display 150 will display one or more detected anatomical landmarks (e.g., detected side branches of a vessel). Figure 8 In FIG. 1 , the intravascular image showing the first two detected side branches is again marked with lines 197 and 198 (eg, Figure 7 During the second half of the translation process, two additional intravascular images are now acquired showing the third and fourth detected side branches and are labeled with lines 199 and 200. As discussed herein, images including detected anatomical landmarks can be automatically identified or labeled, e.g., using image processing and image recognition, or can be manually identified or labeled by a user, e.g., via a user interface.

[0097] In the upper right portion of the display 150 , the image output 152 displays a corresponding intravascular transverse cross-sectional image 452 of the vessel corresponding to the end position in the vessel. Figure 8Also shown is an additional (e.g., third) intermediate extravascular image 551 in image output 153 on display 150. Extravascular image 551 may be obtained by briefly activating the fluoroscope to discern the actual / known position of intravascular imaging device 120, which is shown at the end of the translation process with imaging element 182 disposed at end position 30. At this point, the translation process may be stopped because imaging element 182 has reached end position 30. This may be done automatically by the system, or may be done manually by a user interacting with the system.

[0098] Marking one or more known locations on extravascular imaging data

[0099] Another aspect of the example method for vascular imaging co-registration includes marking the extravascular imaging data for registration. For example, the extravascular imaging data can be marked with actual / known registration points. For example, some embodiments involve marking the start position 20 and / or end position 30 of the translation process on the extravascular imaging data.

[0100] For example, as described herein, the acquired extravascular imaging data includes an extravascular image 151 (eg, Figure 4 ) and the extravascular angiography image 251 (e.g., Figure 5 ). The extravascular image 151 is obtained under fluoroscopy and shows the start position 20 and / or end position 30 of the translation process, which are identified and recognized using the position of the device 120 / 190 or radiopaque markers identified under fluoroscopy. These are examples of actual / known positions or registration points. However, due to the absence of contrast flow, the vessel lumen or anatomical landmarks (such as side branches) may not be easily discernible / identifiable in the image 151. (But they are not Figure 4 On the other hand, the extravascular angiography image 251 ( Figure 5 ) is a vascular angiogram with contrast, so that a portion of the blood vessel is shown with contrast and one or more visualized anatomical landmarks are displayed. Therefore, visualized anatomical landmarks (e.g., side branches) can be identified on the extravascular contrast image 251. However, due to the contrast, the position of the device or the radiopaque markings of the device 120 / 190 are not easily discernible or recognizable in the extravascular contrast image 251. This makes it difficult or impossible to see or identify, for example, actual / known positions or registration points, such as the start position 20 and the end position 30 of the translation process. In some embodiments, it may be necessary to provide an image for marking or registration that includes data from an extravascular image without contrast (e.g., fluoroscopic image 151) and an extravascular contrast image (e.g., contrast image 251).

[0101] In some embodiments, data from the extravascular image 151 showing actual / known locations or registration points, such as the start location 20 and the end location 30 of the translation process, can be combined with or superimposed on the extravascular contrast image 251. In some cases, this process can be done automatically by the system. For example, the computer 130 may include software or hardware configured to perform image processing and image recognition designed to combine or superimpose data in the image. In other cases, the images can be manually combined or superimposed by the user, for example, through a user interface.

[0102] The result of combining or overlaying / superimposing data from the extravascular image 151 (e.g., a fluoroscopic image) with data from the extravascular contrast image 251 (e.g., an angiogram with contrast) may produce a combined or enhanced extravascular image 651 (e.g., an enhanced angiogram), which is extravascular imaging data that is or can be labeled. An example of such an extravascular image 651 is shown in FIG. Fig. 9 It is shown in Fig. 9 An extravascular image 651 generated by the computer 130 and displayed on the image output 153 in the upper left portion of the display 150 is displayed.

[0103] If you can Fig. 9 As understood in the above, the start position 20 or the end position 30 (e.g., the actual / known position or registration point) is identified on the extravascular image 651 and can be marked on the extravascular imaging data. For example, the start position 20 can be marked with a mark 620 on the extravascular image 651. The end position 30 can be marked with a mark 630 on the extravascular image 651. In some cases, the identification or marking process can be automatically performed by the system. For example, the computer 130 may include software or hardware that is configured to perform image processing and image recognition configured to identify and mark the start position 20 or the end position 30 (or other actual / known position or registration point). In other cases, marking the start position 20 or the end position 30 (or other actual / known position or registration point) is performed manually by the user, such as through a user interface.

[0104] During the translation process, other extravascular data or images including or showing other actual / known positions of the imaging elements of the intravascular imaging device 120 may also be combined with or superimposed on the extravascular contrast image 251 or the extravascular image 651. For example, other extravascular images, such as the intermediate extravascular image 351 ( Figure 6 ) or the intermediate extravascular image 451 ( Figure 7 ) or the intermediate extravascular image 551 ( Figure 8) are each also acquired under fluoroscopy during the translation process, and each include the actual / known position of the imaging element 182 of the intravascular imaging device 120 (due to the radiopaque marker 123) at some point during the translation process. Combining or superimposing data from one or more of these additional extravascular images with the angiographic image 251 or the extravascular image 651 can add additional reference points and can help enhance accuracy. The process of merging or superimposing data can be accomplished in a manner as discussed above, for example, automatically by the system or manually by a user. Additionally, specific actual / known positions of the imaging element 182 can also be marked on the extravascular imaging data, with the marking being similar to that discussed above.

[0105] Fig. 9 Also displayed are intravascular images taken when the translation process is nearing completion or has completed. Image output 154 at the bottom of the screen displays longitudinal cross-sectional intravascular images acquired during the translation process (from start to finish). Image output 154 includes intravascular images showing four detected anatomical landmarks (e.g., side branches), which are again marked with lines 197, 198, 199, and 200, respectively. In the upper right portion of display 150, image output 152 displays a corresponding intravascular transverse cross-sectional image 552 of the vessel corresponding to the ending position in the vessel.

[0106] As discussed herein, at least a portion of the translation process may occur or be performed without continuous angiography / fluoroscopy during the collection of intravascular images. In other words, during the translation process, the angiography / fluoroscopy system 104 may not be activated or may only be activated periodically, e.g., to obtain an actual / known position. However, a significant portion or period may also be performed without angiography / fluoroscopy. In such a case, during the translation process, the actual / known position of the intravascular imaging device 120 is not continuously tracked under angiography / fluoroscopy.

[0107] In embodiments where angiography / fluoroscopy is inactive during a significant portion of the translation process, the system can be configured to calculate an approximate or predicted position of the imaging element 182 for those portions of the translation process when angiography / fluoroscopy is inactive (e.g., due to the radiopaque markers 123). For example, such a calculation can be based on its last registered position / location (e.g., the last registered actual / known position of the imaging element 182) and other indicators of catheter movement or position, such as a known pullback distance and speed, a calculated path, or other non-visual position data, etc.

[0108] For example, if the initial position of the imaging element 182 is known (e.g., by one or more actual / known positions or registration points, such as the starting position 20, the ending position 30, or one of the intermediate positions obtained during the translation process, etc.) and the catheter 120 is pulled by an automatic pullback system at a particular rate for a known amount of time, then the calculated / predicted position will be the distance along the path of travel from the initial position and represented by the product of the pullback rate and the time period. The computer 130 or a component thereof may include software or hardware designed to perform such calculations and output the results, e.g., display or mark the calculated / predicted position on a displayed image as desired. For example, the calculated / predicted position for a particular point during the translation process may be superimposed on the extravascular image 651 or a co-registered image, such as Fig.18 , and may represent the calculated / predicted position of the probe 122 or imaging element 182 at that point in the translation process.

[0109] In some embodiments, a calculated path (e.g., a calculated ongoing path) acquired by the imaging element 182 during the translation process can be determined, used, or displayed. For example, the predicted / calculated path can extend between a start position 20 and an end position 30, and can extend generally along the imaged vessel lumen displayed on the extravascular contrast imaging data. Data regarding the calculated path can also be used or considered when calculating the approximate or predicted position of the imaging element 182. Some examples of methods that can be used to determine the calculated path include: user-specified points or manual path specifications; image pattern recognition; automated two-dimensional and three-dimensional path calculations; user-assisted automated path calculations; and combinations of manual and automated calculations of paths. The computer 130 or components thereof can include software or hardware designed to perform or facilitate such calculations and output results, such as displaying or marking the calculated path on a displayed image as desired. For example, the calculated path can be superimposed on the extravascular image 651 or a co-registered image, such as Fig.18 , and may represent the planned path of the probe 122 or imaging element 182 during the translation process.

[0110] As can be appreciated, there may be errors between the calculated / predicted position and the actual / known position. For example, it is expected that during certain periods when fluoroscopy is inactive, retraction problems may occur, and retraction problems may cause errors between the calculated / predicted position and the actual / known position, particularly in tortuous / winding blood vessels. However, at each subsequent time that fluoroscopy is activated and actual / known position data is acquired and presented to the processor, the error between the actual / known position and the predicted / calculated position can be reduced or eliminated by replacing the calculated / predicted position with the actual / known position. Additionally, another aspect of the example method for vascular imaging co-registration disclosed herein includes aligning the predicted position of a particular detected anatomical landmark with a corresponding visualized anatomical landmark, as will be discussed in more detail below. This aspect may also help to mitigate or reduce errors / misalignments.

[0111] Labeling predicted locations of detected anatomical landmarks on extravascular imaging data

[0112] Another aspect of an example method for vascular imaging co-registration includes marking predicted locations of detected anatomical landmarks on extravascular imaging data. The intravascular imaging data acquired during the translation process will include one or more intravascular images showing one or more detected anatomical landmarks. As can be appreciated, these intravascular images showing the detected anatomical landmarks are included in the intravascular imaging data acquired using the intravascular imaging device during the translation process. For the purpose of co-registration, the locations of these detected anatomical landmarks (e.g., from IVUS or OCT data) will be correspondingly identified and / or marked and / or registered on the extravascular imaging data (e.g., angiography / fluoroscopy data). It is useful to know the location (actual / known location or calculated / predicted location) of the imaging element 182 of the intravascular imaging device 120 when a particular detected anatomical landmark is detected during the translation process, which can then be used to mark and / or register that location (of the detected anatomical landmark) on the extravascular imaging data (e.g., angiography / fluoroscopy data).

[0113] In certain specific cases, the location of the detected anatomical landmark is actual / known if the extravascular imaging device (angiography / fluoroscopy) is active at the same time that the particular detected anatomical landmark is detected by the imaging element 182. Using the actual / known location provided by the extravascular imaging, the location of the particular detected anatomical landmark can be marked and / or registered at that location in the extravascular imaging data.

[0114] However, as discussed herein, when collecting intravascular images, at least part (if not most or all) of the translation process is performed in the absence of continuous extravascular imaging (e.g., in the absence of angiography / fluoroscopy). In this case, the actual / known position of the imaging element 182 on the intravascular imaging device 120 when a particular detected anatomical landmark was detected during the translation process will not be known. Therefore, the calculated / predicted position of the imaging element 182 on the intravascular imaging device 120 when a particular detected anatomical landmark was detected during the translation process will be used. Methods and / or systems for determining the calculated / predicted position of the imaging element 182 are described above and can be used in this context. The predicted position of the detected anatomical landmark is then marked on the extravascular imaging data.

[0115] For example, Fig.10 Extravascular imaging data is shown, in this case, extravascular image 751, which can be created in a similar manner and is similar in form and function to Fig. 9 651 of the extravascular image. The extravascular image 751 shows visualized anatomical landmarks, in this case, side branches 12, 14, 16, and 18. Additionally, a predicted position of a detected anatomical landmark 197 (e.g., a first side branch) derived from the intravascular image 154 has been calculated / predicted (as disclosed herein). The predicted position of the detected anatomical landmark 197 is then marked on the extravascular imaging data (e.g., the extravascular image 751) with a marking arrow 212. As can be appreciated, in this case, there is some misalignment / error / difference between the predicted and marked position 212 of the first side branch and the visualized anatomical landmark 12 on the extravascular imaging data.

[0116] It is also noted that in the extravascular image 751, visualized anatomical landmarks (e.g., side branches) are identified and / or identifiable - manually or by the system. In some embodiments, the visualized anatomical landmarks (e.g., side branches 12, 14, 16, 18) can be simply identified manually by a user, for example, by the user evaluating the image on a screen. In some embodiments, the visualized anatomical landmarks (e.g., side branches 12, 14, 16, 18) can be automatically identified by the system. For example, the computer 130 can include software or hardware configured to perform image processing and image recognition. Using the extravascular image data (e.g., angiography data), the system can perform image processing and image recognition to identify the visualized anatomical landmarks (e.g., side branches 12, 14, 16, 18).

[0117] Visual anatomical landmarks may also be marked on the extravascular imaging data. For example, visual anatomical landmarks (e.g., side branches 12, 14, 16, 18) may be marked on the extravascular image 751 with appropriate markings and / or labels. In this case, side branch 12 is marked as SB1, side branch 14 is marked as SB2, side branch 16 is marked as SB3, and side branch 18 is marked as SB4. In some cases, the identification or marking process may be performed automatically by the system. For example, the computer 130 may include software or hardware configured to perform image processing and image recognition configured to identify and mark visual anatomical landmarks. In other cases, marking visual anatomical landmarks may be performed manually by a user, for example, through a user interface.

[0118] Fig.10 Also displayed are intravascular images taken during the translation process. The image output 154 at the bottom of the screen displays longitudinal cross-sectional intravascular images obtained during the translation process (from start to finish). The image output 154 includes an intravascular image showing four detected anatomical landmarks (e.g., side branches), which are again identified and subsequently labeled with lines 197, 198, 199, and 200, as described elsewhere herein. It will also be appreciated that lines 197, 198, 199, and 200 are now labeled and / or identified. In particular, line 197 is now labeled SB1, line 198 is now labeled SB2, line 199 is now labeled SB3, and line 200 is now labeled SB4. The labels / text / symbols on the labels representing the four detected anatomical landmarks (e.g., side branches detected on IVUS) correspond to the labels / text / symbols on the labels giving the corresponding visualized anatomical landmarks (e.g., side branches detected on angiograms). Additionally, each of the now detected anatomical landmarks now also carries an additional label that displays a small representation of the corresponding intravascular transverse cross-sectional image for that particular detected anatomical landmark. Above each text label for each detected anatomical landmark, these small images of the corresponding intravascular transverse cross-sectional image can be seen. In some cases, these markings / labels can be applied automatically by the system. For example, the computer 130 may include software or hardware that is configured to perform image processing and image recognition that is configured to identify and mark / label the landmarks accordingly. In other cases, marking / labeling can be done manually by the user, for example, through a user interface.

[0119] In some cases, these lines / markers / labels can be interactive. For example, through the user interface, a user can activate one of the lines / markers / labels, and the line / marker / label can be highlighted and / or activated. When the line / marker / label of a particular detected anatomical landmark is highlighted or activated, the predicted position of the corresponding marker of the particular detected anatomical landmark is displayed on the extravascular imaging data (e.g., the extravascular image 751), and the corresponding intravascular transverse cross-sectional image 652 of the particular detected anatomical landmark is displayed in the image output 152 in the upper right portion of the display 150.

[0120] For example, Fig.10 As seen in the image output 152, the label SB1 (specifying the detected anatomical landmark 197) is shown as being activated / highlighted, as indicated by the downward arrow above the label. Then, a marking arrow 212 is displayed on the extravascular image 751, which specifies the predicted position of the detected anatomical landmark 197 on the extravascular imaging data. And, the corresponding intravascular transverse cross-sectional image of the detected anatomical landmark 197 is displayed in the image output 152. Each of the other labels can be similarly activated to display corresponding information.

[0121] Align predicted locations of detected anatomical landmarks with visualized anatomical landmarks

[0122] Another aspect of an example method for vascular imaging co-registration includes aligning predicted locations of detected anatomical landmarks with visualized anatomical landmarks.

[0123] As discussed herein, visualized anatomical landmarks are identified and / or identifiable on the extravascular imaging data - either manually or automatically by the system. Optionally, the visualized anatomical landmarks may also be marked on the extravascular imaging data - either manually or automatically by the system. In addition, predicted positions of detected anatomical landmarks may be calculated and marked on the extravascular imaging data - either manually or automatically by the system. However, as discussed herein, there may be some misalignment / error / difference between the predicted and marked positions of anatomical landmarks detected on the extravascular imaging data and the corresponding visualized anatomical landmarks on the extravascular imaging data. The disclosed method for vascular imaging co-registration may include aligning the predicted positions of detected anatomical landmarks with the visualized anatomical landmarks, and may help mitigate such misalignment / error / difference.

[0124] For example, Fig.10A display including extravascular imaging data, in this case an extravascular image 751, is shown, which displays a visualized anatomical landmark 12. The landmark 12 is identified on the extravascular image 751 and is labeled as SB1 (e.g., side branch 1). Additionally, a predicted position of a detected anatomical landmark 197 (also labeled as SB1) derived from the intravascular image 154 is calculated / predicted and marked on the extravascular image 751 with a labeled arrow 212. As can be appreciated, there are some misalignments / errors / differences between the predicted position 212 of the detected anatomical landmark and the identified visualized anatomical landmark 12 on the extravascular imaging data. The methods and systems disclosed herein provide for aligning the predicted position 212 with the visualized anatomical landmark 12. Alignment is typically accomplished by moving or dragging an indicator representing the predicted position 212 on the screen so that it is aligned with the visualized anatomical landmark 12. In some cases, the alignment process can be accomplished automatically by the system. For example, the computer 130 may include software or hardware configured to automatically align the predicted position 212 with the corresponding visualized anatomical landmark 12. This may be done at the direction of the user, or may be done automatically if / when a misalignment is detected. In other cases, alignment may be performed manually by a user, for example, via a user interface. Some examples of manual alignment may include the use of interactive labels discussed above. For example, via a user interface, a user may highlight / activate a label corresponding to a detected anatomical landmark of interest - in this case, detected anatomical landmark 197 with label SB1. When the label of a detected anatomical landmark is highlighted / activated, the predicted position of the corresponding label for that particular detected anatomical landmark is then displayed on the extravascular imaging data - in this case, a label arrow 212 that specifies the predicted position of the detected anatomical landmark 197. The user may then manually move / drag the label arrow 212 to align it with the corresponding visualized anatomical landmark - in this case, visualized anatomical landmark 12. The user may then deactivate the label, for example, to thereby save the alignment. Fig.11 A screen with the same imaging data is displayed, such as Fig.10 , but after aligning the predicted position 212 with the visualized anatomical landmark 12 .

[0125] Similar alignment steps may also be completed for any other predicted positions of additional detected anatomical landmarks and corresponding visualized anatomical landmarks that are misaligned.

[0126] For example, Fig.12A display including extravascular imaging data is shown, in this case an extravascular image 851 that is substantially the same as the extravascular image 751, but focuses on the visualized anatomical landmark 14 and the corresponding predicted position of the detected anatomical landmark 198. The landmark 14 is identified on the extravascular image 851 and is labeled as SB2 (e.g., Side Branch 2). Additionally, the predicted position of the detected anatomical landmark 198 (also labeled as SB2) derived from the intravascular image 154 is calculated / predicted and marked on the extravascular imaging image 851 with a labeled arrow 214. As can be appreciated, there is some misalignment / error / difference between the predicted position 214 of the detected anatomical landmark and the identified visualized anatomical landmark 14 on the extravascular imaging data. The methods and systems disclosed herein also provide for aligning the predicted position 214 with the visualized anatomical landmark 14 in a manner similar to that discussed above to align the predicted position 212 with the visualized anatomical landmark 12. Fig.13 A screen with the same imaging data is displayed, such as Fig.12 , but after aligning the predicted position 214 with the visualized anatomical landmark 14 .

[0127] Similarly, Fig.14 A display including extravascular imaging data is shown, in this case an extravascular image 951 substantially identical to the extravascular images 751 and 851, but focused on the visualized anatomical landmark 16 and the corresponding predicted position of the detected anatomical landmark 199. The landmark 16 is identified on the extravascular image 951 and labeled as SB3 (e.g., Side Branch 3). Additionally, the predicted position of the detected anatomical landmark 199 (also labeled as SB3) derived from the intravascular image 154 is calculated / predicted and marked on the extravascular imaging image 951 with a labeled arrow 216. As can be appreciated, there is some misalignment / error / difference between the predicted position 216 of the detected anatomical landmark and the identified visualized anatomical landmark 16 on the extravascular imaging data. The methods and systems disclosed herein also provide for aligning the predicted position 216 with the visualized anatomical landmark 16 in a manner similar to that discussed above to align the predicted position 212 with the visualized anatomical landmark 12. Fig.15 A screen with the same imaging data is displayed, such as Fig.14 , but after aligning the predicted position 216 with the visualized anatomical landmark 16 .

[0128] Similarly, Fig.16A display including extravascular imaging data is shown, in this case an extravascular image 1051 substantially identical to the extravascular images 751, 851, and 951, but focused on the visualized anatomical landmark 18 and the corresponding predicted position of the detected anatomical landmark 200. The landmark 18 is identified on the extravascular image 1051 and labeled as SB4 (e.g., Side Branch 4). Additionally, the predicted position of the detected anatomical landmark 200 (also labeled SB4) derived from the intravascular image 154 is calculated / predicted and marked on the extravascular imaging image 1051 with a labeled arrow 218. As can be appreciated, there is some misalignment / error / difference between the predicted position 218 of the detected anatomical landmark and the identified visualized anatomical landmark 18 on the extravascular imaging data. The methods and systems disclosed herein also provide for aligning the predicted position 218 with the visualized anatomical landmark 18 in a manner similar to that discussed above to align the predicted position 212 with the visualized anatomical landmark 12. Fig.17 A screen with the same imaging data is displayed, such as Fig.16 , but after aligning the predicted position 218 with the visualized anatomical landmark 18 .

[0129] As a result of the methods and / or systems described herein, the intravascular images generated by the intravascular catheter during the translation process are co-registered with the extravascular images such that each intravascular image (e.g., IVUS or OCT image) is linked to its corresponding location on the extravascular image (e.g., angiography image). The resulting co-registered images can be used to render and present a co-registered display that includes both the extravascular image and the corresponding intravascular image. The co-registered extravascular and intravascular images can be displayed on the display 150 simultaneously, side by side with each other. The co-registered image data can also be stored in the computer 130 or long-term storage device 131 for later review, for example, in a session separate from the process of acquiring the extravascular and intravascular image data. The co-registered display can also be rendered in a playback mode.

[0130] Fig.18 An example of such a resulting co-registered display is shown, which includes both an extravascular image and a corresponding intravascular image. As can be appreciated, the co-registered extravascular image and the intravascular image can be displayed simultaneously side by side with each other on the display 150. For example, the display 150 includes an image output 153 in the upper left portion for displaying the co-registered extravascular imaging data; an image output 154 along the bottom for displaying a co-registered longitudinal cross-sectional intravascular image obtained during the translation process (e.g., from the beginning to the end); and an image output 152 in the upper right portion for displaying a corresponding co-registered transverse cross-sectional intravascular image obtained during the translation process.

[0131] In some embodiments, the system may include software or hardware configured to allow a user to scroll through and / or track a series of co-registered images. For example, the system may include a configuration that allows a user to scroll through one of the co-registered image sets, and while scrolling, the processor acquires and displays the corresponding co-registered images for the other image sets. For example, referring to Fig.18 , a slider bar / cursor 600 may be displayed / superimposed on the image output 154 showing the series of intravascular images acquired during the translation process. Additionally, a corresponding slider bar / cursor 602 may be displayed on the image output 153 along with the extravascular image of the vessel. The two bars / cursors 600 / 602 may be associated and / or linked such that when a user selects and drags the slider bar / cursor 602 along the path (e.g., the calculated path) of the vessel on the co-registered extravascular image shown in the image output 153, the bar / cursor 600 / 6012 correspondingly slides along the corresponding / co-registered image shown in the image output 154. Similarly, when a user selects and drags the slider bar / cursor 600 along the co-registered image displayed in the image output 154, the bar / cursor 602 slides along the path (e.g., the calculated path) of the vessel on the co-registered extravascular image shown in the image output 153. Additionally, as the user moves either of the bars / cursors 600 / 602, the corresponding transverse cross-sectional image of the vessel segment will be displayed in the image output 152 on the screen.

[0132] Another aspect of the method for vascular imaging co-registration may include estimating the accuracy of the imaging co-registration. As discussed herein, there may be some misalignment / error / difference between the predicted and marked positions of anatomical landmarks detected on the extravascular imaging data and the corresponding visualized anatomical landmarks on the extravascular imaging data. As disclosed herein, one aspect of the method for vascular imaging co-registration may include aligning the predicted positions of the detected anatomical landmarks with the visualized anatomical landmarks, and this may help to mitigate some of such misalignment / error / difference in the co-registration. However, the fact that such misalignment / error / difference initially occurs (e.g., before aligning the predicted positions of the detected anatomical landmarks with the visualized anatomical landmarks) may indicate a need, and in some cases a mechanism for estimating the accuracy of the image co-registration may be provided. The system may include software or hardware configured to estimate the accuracy of the co-registration, and in some cases, display and / or otherwise indicate the estimated accuracy level for part or all of the co-registration.

[0133] A variety of methods can be used to estimate the accuracy of co-registration. For example, the errors between the predicted positions of detected anatomical landmarks and the corresponding visualized anatomical landmarks can be measured individually, in groups, or as a whole throughout the co-registration. The magnitude of these measurements can indicate the estimated accuracy level of part or all of the co-registration. For example, if the magnitude of the measured errors is large and / or exceeds certain predetermined thresholds, the predicted accuracy level of the co-registration may be low. On the other hand, if the magnitude of these measurements is large and / or exceeds certain predetermined thresholds, the predicted accuracy level of the co-registration may be low. These accuracy estimates can be made for part or all of the co-registration. Other example factors that can be used to estimate the accuracy of co-registration may include: the total number of actual / known positions or registration points used in the co-registration (e.g., obtained via fluoroscopy); the distance between the actual / known positions or registration points; the total number of alignments performed (e.g., aligning the predicted positions of detected anatomical landmarks with the visualized anatomical landmarks); the distance between the performed alignments; and the tortuosity of the blood vessels being analyzed. Other methods of estimating accuracy may involve the use of curve-based algorithms or formulas, forward prediction formulas or models, etc.

[0134] The estimated accuracy level of co-registration can be performed for all or part of the co-registration and / or for all or each segment of the portion of the analyzed vessel. Once the estimated accuracy level is determined, the estimated accuracy level for all or part of the co-registration is displayed. For example, the system may include software or hardware configured to generate a visual indicator representing the estimated accuracy of the imaging co-registration. In some embodiments, the visual indicator can be displayed and / or superimposed on all or part of the illustrated vessel on the extravascular imaging data. The visual characteristics may include color, symbol, intensity, etc., and may be overlaid / superimposed on or associated with the displayed vessel segment. In some cases, different colors, symbols, intensity levels may be encoded and / or used to indicate the accuracy level. For example, if the accuracy level of a particular segment is determined to be high, one color (e.g., green) may be overlaid on the segment. Alternatively, if the accuracy level of another particular segment is determined to be low, another color (e.g., red) may be overlaid on the segment. As can be appreciated, these are given as examples only, and many other configurations may also be envisioned.

[0135] On the other hand, it is understood that there may be an error between the actual / known position and the calculated position, and the error may be determined or measured. In some embodiments, the error may be taken into account and used to adjust the co-registration. For example, the ratio of error / total distance traveled may be used as a scaling factor to recalculate and adjust the previously calculated / predicted position on the extravascular image (e.g., angiogram) for the entire previous period in which the fluoroscopy was inactive.

[0136] In some cases, it may be beneficial to use the co-registered intravascular imaging data and extravascular imaging data to determine a location of interest for performing a subsequent medical procedure or analysis. For example, the location of interest may represent a specific location within a specific blood vessel. The location of interest may define a specific starting point and a specific end point (e.g., a range) within a specific blood vessel for performing a specific medical procedure or analysis. In studying the co-registered intravascular imaging data and extravascular imaging data to determine the location of interest, a physician or other professional may, as will be discussed, drop one or more markers or bookmarks onto the co-registered intravascular imaging data and extravascular imaging data to subsequently identify the location of interest.

[0137] Examples of subsequent medical procedures or analyses include, but are not limited to, angioplasty, atherectomy and / or stenting, physiological measurements (e.g., pressure measurements, including FFR (fractional flow reserve) measurements, iFR (instantaneous waveform-free ratio) measurements, DFR (diastolic non-hyperemia ratio) measurements, etc.). The co-registered intravascular imaging data and extravascular imaging data can be used to guide other diagnostic procedures, such as, but not limited to, diagnostic angiography and coronary artery physiology examinations. The co-registered intravascular imaging data and extravascular imaging data can be used to reduce the use of x-ray contrast agents because a physician or other professional does not need to inject contrast agents to confirm the location of interest. In some cases, for example, a physician or other professional can study the intravascular image data, the extravascular image data, and even the co-registration between the intravascular image data and the extravascular image data (e.g., the co-registered image data) to determine the appropriate location within the patient's blood vessels in order to perform a subsequent medical procedure or analysis.

[0138] For example, this can include giving the patient access to a catheterization laboratory, such as Figure 1As shown in system 102 of , in order to obtain and co-register extravascular image data (e.g., angiography / fluoroscopy) and intravascular image data (e.g., IVUS or OCT images), as described herein. Subsequently, a physician or other professional can study the data to determine whether the patient is a candidate for a particular medical procedure or analysis, as well as to determine a location of interest, i.e., an optimal location, within the vessel for performing the particular medical procedure or analysis. If the physician or other professional determines that the patient is a candidate for stent implantation, the physician or other professional can use the co-registered data to determine where to implant the stent, thereby determining the location of interest. If the physician or other professional determines that the patient is a candidate for, for example, balloon angioplasty, the physician or other professional can use the co-registered data to determine exactly where the balloon angioplasty should be performed, thereby determining the location of interest. If the physician or other professional determines that the patient is a candidate for rotational atherectomy, the physician or other professional can use the co-registered data to locate the plaque that needs to be removed, thereby determining the location of interest. If a physician or other professional determines that the patient is a candidate for performing a particular medical procedure or analysis on the patient, the physician or other professional can use the co-registered data to determine one or more locations within the vessel for performing the particular medical procedure or analysis, thereby determining the location or locations of interest.

[0139] Once the physician or other professional has studied the co-registered data and determined a course of action for a particular patient, the physician or other professional may return the patient to the catheterization laboratory so that a subsequent procedure may be performed. Fig.19 is a view of a catheterization room 240. The catheterization room 240 may be similar to Figure 1 1, but in this case, the intravascular subsystem 106 including an intravascular imaging device, such as an imaging catheter 120, has been retracted. The catheterization laboratory 240 may include additional equipment (not shown) for performing any of a variety of different catheter-based interventions, such as stent implantation, balloon angioplasty, balloon cutting procedures, atherectomy, etc.

[0140] In some cases, once the physician or other professional has determined a course of action for the patient, including determining what medical procedure to perform and the approximate and / or exact location within the blood vessel where the procedure should be performed, thereby determining the location of interest, the physician or other professional can drop one or more bookmarks or markers onto the co-registered data to mark the location of interest. Although the co-registered data may be located in the IVUS control unit 126, computer 130, or data archive or memory 131, the co-registered data or at least a portion thereof can be transmitted to the display 150 for display for viewing by the physician or other professional. In some cases, the co-registered data can be displayed on a display that is part of an extravascular imaging system, such as, for example, a fluoroscopic system.

[0141] In some cases, extravascular imaging data of a portion of a blood vessel can be obtained, the extravascular imaging data including an extravascular image showing an intravascular imaging device disposed within the blood vessel, wherein an imaging element of the intravascular imaging device is disposed at a starting position of a translation process, and during the translation process, the imaging element is translated within the blood vessel from the starting position to an ending position. An extravascular contrast image is obtained, which displays a portion of the blood vessel with contrast and displays visualized anatomical landmarks. During the translation process, intravascular imaging data from the intravascular imaging device is obtained, the intravascular imaging data including one or more intravascular images showing detected anatomical landmarks. The detected anatomical landmarks and the visualized anatomical landmarks are used to co-register the intravascular imaging data with the extravascular imaging data, as discussed herein. Subsequently, a location of interest within the blood vessel between the starting position and the ending position is determined and can be displayed on a real-time fluoroscopic session display. Determining the location of interest can include dropping one or more markers or bookmarks onto the co-registered intravascular imaging data and the extravascular imaging data. Displaying the location of interest on the real-time fluoroscopic display can, for example, include displaying one or more markers or bookmarks.

[0142] In some cases, a method for determining a location for performing a medical procedure includes obtaining extravascular imaging data of a portion of a blood vessel, the extravascular imaging data including an extravascular image showing a start position and an end position of a translation process during which an intravascular imaging element is translated within the blood vessel from the start position to the end position. Intravascular imaging data is obtained from an intravascular imaging device during the translation process. The intravascular imaging data is co-registered with the extravascular imaging data to create co-registered imaging data. The data can be co-registered, for example, using any of the co-registration methods described herein. In some cases, the co-registered intravascular imaging data and the extravascular imaging data can be displayed. The co-registered imaging data is used to determine a location of interest within the portion of the blood vessel located between the start position and the end position. The location of interest can be displayed, for example, on a real-time fluoroscopy session display.

[0143] In some cases, determining a location of interest within a blood vessel between a start location and an end location may include automatically determining the location of interest based on intravascular imaging data. In some cases, this may include a process called ALA (automatic lesion assessment). Details and features regarding ALA are described, for example, in U.S. Patent Application No. 17 / 683,654 filed on March 1, 2022; U.S. Patent Application No. 63 / 233,875 filed on August 17, 2021; and 63 / 253,881 filed on October 8, 2021. Each of these three applications is incorporated herein by reference. For example, one or more of the components of the system, such as computer 130, may include software or hardware configured to perform image processing and / or image recognition configured to identify one or more locations and / or places of interest. Additionally, the software or hardware may be configured to mark and / or label the locations and / or places of interest accordingly.

[0144] In other cases, determining the location of interest and / or marking / labeling can be done manually by a user, for example, through a user interface. For example, the system software can allow a user to place a mark and / or label at a desired location on the image by using a user interface. A physician or other professional can study the displayed co-registered intravascular imaging data and extravascular imaging data and manually identify one or more locations of interest. In some cases, a physician or other professional can manually mark a location or locations of interest. This can include a physician or other professional manually dropping one or more marks or bookmarks onto the displayed co-registered intravascular imaging data and extravascular imaging data.

[0145] In some cases and with reference to Fig.19 , displaying the location of interest on the real-time fluoroscopic display can also include providing the location of interest to the real-time fluoroscopic machine via a data link with the real-time fluoroscopic display. For example, the data link can be represented by a transmission cable 121. In some cases, the data link can be bidirectional, allowing communication in both directions. In some cases, a data security protocol can be implemented to ensure the integrity of the data and ensure patient privacy. In some cases, at least some of the elements of the catheter room 240, such as but not including the computer 130 and the data storage device 131, may be away from the catheter room 240. Therefore, the data link can include a LAN (local area network) or a WAN (wide area network). In some cases, the data link can include the Internet.

[0146] Another example includes a method for determining a location of interest for performing a medical procedure or analysis. Examples of possible medical procedures include, but are not limited to, angioplasty, atherectomy, balloon-cutting surgery, and / or stent implantation. Examples of analyses that may be performed include physiological measurements, such as pressure measurements, including FFR (fractional flow reserve) measurements, iFR (instantaneous waveform-free ratio) measurements, DFR (diastolic non-hyperemia ratio) measurements, and the like.

[0147] The method includes obtaining extravascular imaging data for a portion of a blood vessel and obtaining intravascular imaging data for the same portion of the blood vessel. The intravascular imaging data is co-registered with the extravascular imaging data. A location of interest for performing a medical procedure or analysis is determined and the location of interest is displayed on a real-time fluoroscopic session display. In some cases, determining the location of interest may include studying the co-registered intravascular imaging data and the extravascular imaging data to determine one or more points of interest, and dropping one or more markers or bookmarks onto the co-registered intravascular imaging data and the extravascular imaging data to indicate the location of interest. Displaying the location of interest on the real-time fluoroscopic display may, for example, include displaying one or more markers or bookmarks.

[0148] Another example includes a method for determining a location of interest for implanting a stent. The method includes obtaining extravascular imaging data of a portion of a blood vessel and obtaining intravascular imaging data for the same portion of the blood vessel. The intravascular imaging data is co-registered with the extravascular imaging data. The desired implantation location for implanting the stent is determined, thereby identifying the location of interest displayed on the real-time fluoroscopic session display. In some cases, determining the location of interest for implanting the stent may include studying the co-registered intravascular imaging data and the extravascular imaging data to determine one or more points of interest, and causing one or more marks or bookmarks to be dropped onto the co-registered intravascular imaging data and the extravascular imaging data to indicate the location of interest. In some cases, the point of interest can be determined automatically. In some cases, the point of interest can be determined manually. Displaying the location of interest on the real-time fluoroscopic display may, for example, include displaying one or more marks or bookmarks.

[0149] Alternatively or additionally, displaying the desired location of interest may include displaying one or more of a distal marker indicating the distal end of the location of interest and a proximal marker indicating the proximal end of the location of interest. For example, the location of interest may be viewed as extending between the distal marker and the proximal marker. A specific blood vessel may have one, two or more locations of interest, each of which is located along the blood vessel. In some cases, each of the locations of interest within the blood vessel may include a distal marker and a proximal marker. In some cases, the marker indicating each of the locations of interest may have a unique color, so that, for example, it is easier to see the position of the first location of interest relative to the second location of interest. In some cases, each distal marker may share a first color, while each proximal marker may share a second color. For example, each distal marker may be green, while each proximal marker may be yellow. A person viewing the marker will be able to identify the distal and proximal ends of each of the locations of interest.

[0150] In some cases, the location of interest can be displayed on real-time fluoroscopy in the intravascular imaging console via a real-time data connection from the fluoroscopy machine. The display of the location of interest can be automatically synchronized with cardiac motion using ECC gating. In some cases, the display of the location of interest can be automatically synchronized with motion analysis of a radiopaque object, such as a guide catheter or guidewire.

[0151] The location of interest or two or more locations of interest can each define a desired location for performing a medical procedure, such as, balloon angiography, rotational atherectomy. For example, the location of interest can define a desired stent implantation location. In some cases, a first location of interest within a particular blood vessel may be a candidate location for a first medical procedure, while a second location of interest within the same blood vessel, but spaced apart from the first location of interest, may be a candidate location for a second medical procedure. As an example, the first location of interest may be a candidate location for rotational atherectomy, while the second location of interest may be a candidate location for balloon angioplasty. In some cases, the location of interest may be a candidate location for multiple medical procedures. As an example, a particular location of interest may be a candidate location for rotational atherectomy or balloon angioplasty, followed by implanting a stent to maintain the patency of the blood vessel achieved during the initial procedure to open the blood vessel. This is just one example.

[0152] Fig. 202 is a schematic diagram of a display 250 showing an example real-time fluoroscopic image 252. It should be understood that the real-time fluoroscopic image 252 is similar to the angiography / fluoroscopic image 151, which shows the same portion of the patient's blood vessel as previously captured in the co-registered image. The real-time fluoroscopic image 252 includes a marker 254 that has been superimposed on a portion of the side branch 256. The marker 254 may have been placed on the co-registered data by a physician or other professional, or may have been automatically placed by the system via, for example, ALA, and has been transmitted to the real-time fluoroscopic image 252 and superimposed thereon. In some cases, only a single marker 254 is required. In the case where only a single marker 254 is used, the marker 254 can, for example, indicate a location of interest, such as the distal end of a treatment site. For example, the marker 254 can indicate where the distal end of a stent should be located, or where other treatments can be performed. The marker 254 can indicate the most distal end of a plaque to be removed by atherectomy, or where the distal end of a balloon used to perform balloon angioplasty should be located before the balloon is inflated. These are merely examples, as other potential vascular treatment examples are known and are under consideration.

[0153] Fig.21 2 is a schematic diagram of display 250 showing an example extravascular image, such as a real-time fluoroscopic image 258. Real-time fluoroscopic image 258 is similar to real-time fluoroscopic image 252, but includes a marker 254 and a second marker 260 that has been superimposed on side branch 256. Marker 260 may have been placed on co-registered data by a physician or other professional (e.g., through a system user interface) or automatically via, for example, ALA, and has been transmitted to and superimposed on real-time fluoroscopic image 258. It should be understood that the combined marker 254 and marker 260 can mark a location of interest, in this case, a treatment zone between marker 254 and marker 260. In some cases, for example, marker 254 can be considered a distal marker, while marker 260 can be considered a proximal marker.

[0154] If the patient is scheduled to have a stent implanted, marker 254 can indicate where the distal end of the stent should be located, and marker 260 can correspondingly indicate where the proximal end of the stent can be located. The distance between marker 254 and marker 260 can indicate an area to perform various other potential treatments, such as, for example, any of atherectomy, balloon angioplasty, cutting balloon therapy, physiological measurements, thrombectomy, additional imaging, etc.

[0155] When viewing the co-registered intravascular imaging data and extravascular imaging data, a physician or other professional can drop additional bookmarks or other marks to indicate one or more additional locations and / or points of interest. These may include areas that the physician or other professional is not sure whether treatment will be needed, but hopes to view again under real-time fluoroscopy or other imaging or testing techniques. A physician or other professional can drop a first mark or bookmark to indicate, for example, a first position in a vessel that may require a first type, style or size of stent, while a second position in the vessel may require a second type, style or size of stent. In addition to the marks or bookmarks, these marks or bookmarks indicating distal and proximal landing zones can be placed manually or automatically. Examples of reasons for placing additional marks or bookmarks that can be considered secondary marks or bookmarks (where those indicating distal and proximal landing zones are considered primary marks or bookmarks) include calcium locations and stent edges.

[0156] In some cases, it may be desirable to display real-time fluoroscopic data instead of or in addition to e.g. Fig.18 The co-registered data shown in . Fig. 22 and Fig.18 Similar, but Fig.18 The co-registered data shown in FIG. 1 has been replaced by a real-time fluoroscopic image 258. As shown, this allows a physician or other professional to see the intravascular imaging data (IVUS data) on the screen simultaneously with the real-time fluoroscopic image 258. In some cases, the real-time fluoroscopic image 258 may be displayed alongside or otherwise combined with the previous angiography / fluoroscopic image 151, depending on how the screen is laid out.

[0157] Fig.23 An example of such a resulting co-registered display is shown, which includes both an extravascular image and a corresponding intravascular image. As can be appreciated, the co-registered extravascular image and the intravascular image can be displayed simultaneously side by side with each other on the display 150. For example, the display 150 includes an image output 153 in the upper left portion for displaying co-registered extravascular imaging data 262; an image output 154 along the bottom for schematically displaying a co-registered longitudinal cross-sectional intravascular image 264 obtained during the translation process (e.g., from the beginning to the end); and an image output 152 in the upper right portion for schematically displaying a corresponding co-registered transverse cross-sectional intravascular image 266 obtained during the translation process.

[0158] In some cases, as shown, the image output 154 includes a stylized representation 268 of a portion of a vessel schematically shown in the longitudinal cross-sectional intravascular image 264. As can be seen, the effective cross-sectional diameter of the vessel as shown in the stylized representation 268 varies with changes in the anatomical structure of the vessel, including areas of plaque within the vessel. In some cases, the stylized representation 268 may include a digital marker, for example, indicating the effective diameter of the vessel at a particular location. In some embodiments, the system may include software or hardware that is configured to allow a user to scroll through and / or track a series of co-registered images. For example, the system may include a configuration that allows a user to scroll through one of the co-registered image sets, and while scrolling, the processor acquires and displays corresponding co-registered images for other image sets.

[0159] For example, refer to Fig.23 , an interactive slider 270 can be superimposed on the stylized representation 268 of the blood vessel. The interactive slider 270 includes a first slider bar 272 that can be used to indicate the start point of the location of interest and a second slider bar 274 that can be used to indicate the end point of the location of interest. In some cases, the first slider bar 272 can be used to indicate a distal point 276, for example, as seen on the co-registered extravascular imaging data 262 shown in the image output 153. The second slider bar 274 can be used to indicate a proximal point 278, for example, as seen on the co-registered extravascular imaging data 262 shown in the image output 153. Once the physician or other professional has placed the first slider bar 272 and the second slider bar 274 at the locations where the interactive slider 270 marks the location of interest, the system can allow the physician or other professional to indicate to the system that they wish to place marks or bookmarks at these locations. The first slider bar 272 can include a first cursor button 272a, which allows the physician or other professional to move the first slider bar 272, for example, by touching and dragging the first cursor button 272a. In some cases, the physician or other professional may use, for example, a mouse or keyboard to move the first slide bar 272. The second slide bar 274 may include a second cursor button 274a that allows the physician or other professional to move the second slide bar 274, for example, by touching and dragging the second cursor button 274a. In some cases, the physician or other professional may use, for example, a mouse or keyboard to move the second slide bar 274.

[0160] The interactive slider 270 includes a bar 280 that correlates the position of a first slider bar 272 relative to the schematic diagram 268 with the co-registered longitudinal cross-sectional intravascular image 264. In some cases, the bar 280 includes a touch point 280a that can be used to move the position of the bar 280 in a manner similar to the first cursor 272a. Moving the bar 280 causes the first slider bar 272 to move in a similar manner. When the interactive slider 270 is manipulated, such as by moving the first slider bar 272, it should be understood that the co-registered transverse cross-sectional intravascular image 266 displayed in the image output 152 will change to correspond to the indicated position within the registered longitudinal cross-sectional intravascular image 264 shown in the image output 154. In some cases, a corresponding slider indicator 288 may appear on the co-registered extravascular imaging data 262 shown in the image output 153. In some cases, the interactive slider 270 may include a MIN indicator 282 that graphically illustrates a point within the displayed portion of the vessel having a minimum effective diameter. This may be a result of the native anatomy of the vessel, or may indicate a location where accumulated plaque has narrowed the vessel.

[0161] Thus, the illustrated position of the interactive slider 270 can indicate a location of interest defined between the first slider 272 and the second slider 274. Similarly, the two corresponding markers 276 and 278 as shown on the co-registered extravascular imaging data 262 can be viewed as defining a location of interest where a physician or other professional deems it necessary to perform a medical procedure or analysis. In some cases, as shown, the co-registered extravascular imaging data 262 can include a starting point 284 and an end point 286. The starting point 284 and the end point 286 can represent the starting point and end point of the IVUS pullback that generated the displayed data, respectively. It should be understood that the starting point 284 and the end point 286 can indicate a range in which a physician or other professional can view the co-registered intravascular imaging data and the extravascular imaging data.

[0162] It should be understood that the present invention is in many respects merely illustrative. Changes may be made in details, particularly in matters of arrangement of shape, size and steps, without exceeding the scope of the present invention. To the extent appropriate, this may include using any of the features of an example embodiment used in other embodiments. Of course, the scope of the present invention is defined by the language of the appended claims.

Claims

1. A method for determining a location of interest for performing a medical procedure, the method comprising: Obtaining extravascular imaging data of a portion of a blood vessel, the extravascular imaging data comprising: an extravascular image showing a start position and an end position for a translation process during which an intravascular imaging element is translated within the blood vessel from the start position to the end position; obtaining intravascular imaging data from the intravascular imaging device during the translation process; co-registering the intravascular imaging data with the extravascular imaging data to create co-registered imaging data; using the co-registered imaging data to determine a location of interest within the portion of the blood vessel between the starting location and the ending location; and The location of interest is displayed on the real-time fluoroscopy session display.

2. The method according to claim 1, wherein: Determining a location of interest within the blood vessel between the start location and the end location includes automatically determining the location of interest based on the intravascular imaging data.

3. The method according to any one of claims 1 or 2, wherein: Displaying the location of interest on the real-time fluoroscopy session display includes using a real-time data connection from a fluoroscopy machine.

4. The method according to any one of claims 1 or 3, wherein: Displaying the location of interest on the real-time fluoroscopy session display further includes automatically synchronizing the location of interest with cardiac motion via ECC gating.

5. The method according to any one of claims 1 or 4, wherein: Displaying the location of interest on the real-time fluoroscopy session display further includes automatically synchronizing the location of interest with a motion analysis of a radiopaque object.

6. The method according to any one of claims 1 to 5, further comprising displaying the co-registered intravascular imaging data and extravascular imaging data.

7. The method according to claim 6, wherein: Determining a location of interest within the blood vessel between the start location and the end location includes examining the displayed co-registered intravascular imaging data and extravascular imaging data.

8. The method according to any one of claims 1 to 7, wherein: The medical procedure includes implanting a stent.

9. The method according to claim 8, wherein: Displaying the location of interest on the real-time fluoroscopic display includes displaying a distal marker indicating a target location of a distal end of the stent.

10. The method according to any one of claims 8 or 9, wherein: Displaying the location of interest on the real-time fluoroscopic display further includes displaying a proximal marker indicating a target location of the proximal end of the stent.

11. The method according to any one of claims 1 or 10, wherein: Displaying the location of interest on a real-time fluoroscopic display further comprises providing the location of interest to the real-time fluoroscopic machine via a data link with the real-time fluoroscopic display.

12. The method according to claim 11, wherein: The data link comprises a bidirectional data link.

13. The method of any one of claims 1 to 12, further comprising transmitting data from the real-time fluoroscopic display to a display that displays the co-registered intravascular imaging data and extravascular imaging data.

14. The method of any one of claims 1 to 13, further comprising implementing data security protocols to ensure the integrity of the data and protect patient privacy.

15. The method according to any one of claims 11 to 14, wherein: The data link includes the Internet.

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