Systems and methods for co-registration of vascular images - Patents.com

Abstract

The present disclosure provides a method for co-registration of vascular imaging and a method for using the co-registered imaging data to guide live fluoroscopy. The extravascular imaging data includes an extravascular contrast image showing a portion of a blood vessel in contrast showing a visualized anatomical landmark, and the intravascular imaging data includes one or more intravascular images acquired during a translation procedure showing the detected anatomical landmark. The start and end positions of the imaging elements on the extravascular imaging data are marked, and the predicted positions of the detected anatomical landmarks on the extravascular imaging data are marked. The predicted positions of the detected anatomical landmarks are then aligned with the visualized anatomical landmarks.

Description

[Technical field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical imaging and systems and methods for medical imaging. More particularly, the present disclosure relates to systems and methods for vascular imaging, including intravascular and extravascular imaging and co-registration. [Background technology]

[0002] A wide variety of medical imaging systems and methods have been developed for use in medical applications, such as imaging vascular anatomical structures. Some of these systems and methods include intravascular and extravascular imaging modalities for imaging vascular structures. These systems and methods include a variety of configurations and may operate or be used according to any one of a variety of methods. Each of the known vascular imaging systems and methods has certain advantages and disadvantages. Thus, there is a continuing need to provide alternative systems and methods for vascular imaging and evaluation, as well as imaging co-registration. Summary of the Invention

[0003] The present disclosure provides alternative medical imaging systems and methods. An example includes a method for determining a location of interest for performing a medical procedure. The method includes acquiring 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, an imaging element of the intravascular imaging device being disposed at a start position for a translation procedure in which the imaging element is translated within the blood vessel from a start position to an end position. An extravascular contrast image showing the portion of the blood vessel in contrast and showing visualized anatomical landmarks is acquired. Intravascular imaging data is acquired from the intravascular imaging device during the translation procedure, the intravascular imaging data including one or more intravascular images showing the 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 start position and the end position is determined. The location of interest is displayed on a live fluoroscopy session display.

[0004] Another example includes a method for determining a location for performing a medical procedure. The method includes acquiring extravascular imaging data of a portion of a blood vessel, the extravascular imaging data including an extravascular image indicating a start and end location for a translation procedure in which an intravascular imaging element is translated within the blood vessel from a start location to an end location. The intravascular imaging data is acquired from the intravascular imaging device during the translation procedure. The intravascular imaging data is co-registered with the extravascular imaging data to create co-registered imaging data. The co-registered imaging data is used to determine a location of interest within the portion of the blood vessel between the start and end locations. The location of interest is displayed on a live fluoroscopy session display.

[0005] Alternatively or additionally, determining a location of interest within the vessel between the start location and the end location may include automatically determining the location of interest based on intravascular imaging data.

[0006] Alternatively or additionally, the method may further include displaying the co-registered intravascular and extravascular imaging data. Alternatively or additionally, the location of interest on the live fluoroscopy may be displayed within the intravascular imaging console via a real-time data connection from the fluoroscope.

[0007] Alternatively or additionally, the location of interest displayed on live fluoroscopy may be automatically synchronized with cardiac motion via ECC gating. Alternatively or additionally, the location of interest displayed on the live fluoroscopy may be automatically synchronized with the motion analysis of a radiopaque object such as a guide catheter or guidewire.

[0008] Alternatively or additionally, the step of determining the intravascular location of interest between the start location and the end location may include analyzing the displayed co-registered intravascular and extravascular imaging data.

[0009] Alternatively or additionally, the medical procedure may include placing a stent. Alternatively or additionally, the step of displaying the location of interest on the live fluoroscopy display may include displaying a distal marker indicating a target location of a distal end of the stent.

[0010] Alternatively or additionally, the step of displaying the location of interest on the live fluoroscopy display may further include displaying a proximal marker indicating a target location of a proximal end of the stent. Alternatively or additionally, the step of displaying the location of interest on a live fluoroscopy display may further include providing the location of interest to a live fluoroscope via a data link with the live fluoroscopy display.

[0011] Alternatively or additionally, the data link may include a bidirectional data link. Alternatively or additionally, the method may further include transmitting data from the live fluoroscopic display to a display displaying the co-registered intravascular and extravascular imaging data.

[0012] Alternatively or additionally, the data link may include the Internet. Alternatively or additionally, the extravascular imaging data may include one or both of angiographic image data and fluoroscopic image data.

[0013] Alternatively or additionally, the intravascular imaging data may include one or more of intravascular ultrasound data and optical coherence tomography data. Alternatively or additionally, the translation procedure can be a pullback.

[0014] Another example includes a method for determining a location of interest for performing a medical procedure. The method includes acquiring extravascular imaging data for a portion of a blood vessel and acquiring intravascular imaging data for the same portion of the blood vessel. The intravascular imaging data is co-registered with the extravascular imaging data. The location of interest for performing the medical procedure is determined and the location of interest is displayed on a live fluoroscopy session display.

[0015] Alternatively or additionally, the medical procedure may include placing a stent. Alternatively or additionally, displaying the location of interest on the live fluoroscopy display may include displaying a distal marker indicating a target location of a distal end of the stent.

[0016] Alternatively or additionally, the step of displaying the location of interest on the live fluoroscopy display may further include displaying a proximal marker indicating a target location of a proximal end of the stent. Another example includes a method for determining a location of interest for placing a stent. The method includes acquiring extravascular imaging data for a portion of a blood vessel and acquiring intravascular imaging data for the same portion of the blood vessel. The intravascular imaging data is co-registered with the extravascular imaging data. A desired placement location for placing a stent is determined and displayed on a live fluoroscopy session display.

[0017] Alternatively or additionally, displaying the desired stent placement location may include displaying one or more of a distal marker indicating a target location at a distal end of the stent and a proximal marker indicating a target location at a proximal end of the stent.

[0018] The above summary of some embodiments is not intended to describe each disclosed embodiment or every implementation of the present disclosure. The following figures and detailed description more particularly exemplify these embodiments. [Brief description of the drawings]

[0019] The present disclosure can be more fully understood from the following detailed description considered in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 is a schematic diagram of an exemplary system for use in vascular imaging coregistration. [Diagram 2] FIG. 2 is a schematic diagram of an exemplary intravascular imaging catheter, shown in partial cross-section. [Diagram 3] FIG. 3 is a schematic diagram of a distal portion of the exemplary intravascular imaging catheter of FIG. 2, shown in cross-section. [Figure 4] FIG. 4 is a schematic diagram of a display showing an example of an extravascular image. [Diagram 5] FIG. 5 is a schematic diagram of a display showing an example of an extravascular contrast image. [Figure 6] FIG. 6 is a schematic diagram of a display showing an example of an extravascular image and corresponding intravascular imaging, including transverse and longitudinal cross-sectional images, acquired during the beginning portion of a translation procedure. [Figure 7] FIG. 7 is a schematic diagram of a display showing an example of an extravascular image and corresponding intravascular imaging, including transverse and longitudinal cross-sectional images, acquired during an intermediate portion of a translation procedure. [Figure 8] FIG. 8 is a schematic diagram of a display showing an example of an extravascular image and corresponding intravascular imaging, including transverse and longitudinal cross-sectional images, acquired during the end portion of a translation procedure. [Figure 9] FIG. 9 is a schematic diagram of a display showing an example of a combined extravascular image marked with the start and end positions of a translation procedure, along with corresponding intravascular imaging including transverse and longitudinal cross-sectional images. [Figure 10] FIG. 10 is a schematic diagram of a display showing an example of an extravascular image including marked predicted locations of detected anatomical landmarks, along with corresponding intravascular imaging including transverse and longitudinal cross-sectional images. [Figure 11] FIG. 11 is a schematic diagram of a display such as that of FIG. 10 showing marked predicted locations of detected anatomical landmarks aligned with visualized anatomical landmarks, as well as corresponding intravascular imaging including transverse and longitudinal cross-sectional images. [Figure 12] FIG. 12 is a schematic diagram of a display showing an example of an extravascular image including a marked predicted location of a second detected anatomical landmark, along with corresponding intravascular imaging including a transverse cross-sectional image and a longitudinal cross-sectional image. [Figure 13]FIG. 13 is a schematic diagram of a display such as that of FIG. 12 showing a marked predicted location of a second detected anatomical landmark aligned with a second visualized anatomical landmark, along with corresponding intravascular imaging including transverse and longitudinal cross-sectional images. [Figure 14] FIG. 14 is a schematic diagram of a display showing an example of an extravascular image including a marked predicted location of a third detected anatomical landmark, along with corresponding intravascular imaging including a transverse cross-sectional image and a longitudinal cross-sectional image. [Figure 15] FIG. 15 is a schematic diagram of a display such as that of FIG. 14 showing a marked predicted position of a third detected anatomical landmark aligned with a third visualized anatomical landmark, along with corresponding intravascular imaging including transverse and longitudinal cross-sectional images. [Figure 16] FIG. 16 is a schematic diagram of a display showing an example of an extravascular image including a marked predicted location of a fourth detected anatomical landmark, along with corresponding intravascular imaging including a transverse cross-sectional image and a longitudinal cross-sectional image. [Figure 17] FIG. 17 is a schematic diagram of a display such as that of FIG. 16 showing a marked predicted position of a fourth detected anatomical landmark aligned with a fourth visualized anatomical landmark, as well as corresponding intravascular imaging including transverse and longitudinal cross-sectional images. [Figure 18] FIG. 18 is a schematic diagram of a display showing a co-registered image including an exemplary extravascular image, along with corresponding intravascular imaging including transverse and longitudinal cross-sectional images. [Figure 19] 1 is a schematic diagram of an exemplary catheterization lab. [Figure 20] FIG. 1 illustrates an exemplary live fluoroscopic image. [Figure 21] FIG. 1 illustrates an exemplary live fluoroscopic image. [Figure 22]FIG. 1 is a schematic diagram of a display showing an exemplary live fluoroscopic image and corresponding intravascular imaging including transverse and longitudinal cross-sectional images. [Diagram 23] FIG. 1 is a schematic diagram of a display showing a co-registered image including an exemplary extravascular image, as well as corresponding intravascular imaging including transverse and longitudinal cross-sectional images shown diagrammatically in combination with an interactive slider mechanism. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0020] While the present disclosure is amenable to various modifications and alternative forms, details of which have been shown by way of example in the drawings and will be described in detail. It should be understood, however, that the intention is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the disclosure.

[0021] For the following defined terms, these definitions shall be applied, unless a different definition is given in the claims or elsewhere in this specification. All numerical values ​​are assumed to be modified herein by the term "about", whether or not expressly indicated. The term "about" generally refers to a range of numbers that one of ordinary skill in the art would consider equivalent to the recited value (e.g., having the same function or result). In many instances, the term "about" may include numbers that are rounded to the nearest significant figure.

[0022] The recitation of numerical ranges by endpoints includes all numbers within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). 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 used in its sense including "or" unless the content clearly dictates otherwise.

[0023] It should be noted that references herein to "one embodiment," "some embodiments," "other embodiments," etc., indicate that the described embodiment may include one or more particular features, structures, or characteristics. However, such a description does not necessarily mean that all embodiments include the particular feature, structure, or characteristic. In addition, if a particular feature, structure, or characteristic is described in connection with one embodiment, it should be understood that such feature, structure, or characteristic may be used in connection with other embodiments, whether or not explicitly described, unless expressly stated to the contrary.

[0024] The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered the same. The drawings, which are not necessarily to scale, depict illustrative embodiments and are not intended to limit the scope of the invention.

[0025] A number of different medical imaging modalities can be used to evaluate or treat blood vessels. Two common types of imaging modalities include extravascular imaging modalities and intravascular imaging modalities. The present disclosure relates to the use and co-registration of these modalities.

[0026] Extravascular imaging modalities, such as various forms of radiological imaging, provide extravascular imaging data of a portion of a blood vessel. Some examples include angiographic or fluoroscopic imaging modalities, such as 2-dimensional angiography / fluoroscopy, 3-dimensional angiography / fluoroscopy, or computed tomography angiography / fluoroscopy. Angiography typically involves rendering a radiographic image of one or more blood vessels, often using a radiopaque contrast agent. Angiographic images can also be viewed in real time by fluoroscopy. In general, fluoroscopy uses less radiation than angiography and is often used to guide medical devices that include radiopaque markers in or through blood vessels. Extravascular imaging data of blood vessels can provide useful information regarding the location or positioning of blood vessels, anatomy, or devices within the blood vessels or anatomy. For example, extravascular imaging data (e.g., angiograms) can provide a comprehensive overall picture or a series of images or videos of a vessel of interest, and can provide a "roadmap" with good temporal resolution for general assessment of the vessel or navigation of a device within the vessel.

[0027] Intravascular imaging modalities provide intravascular imaging data of a portion of a blood vessel. Some examples of intravascular imaging modalities include intravascular ultrasound (IVUS) and optical coherence tomography (OCT). These modalities typically involve imaging the blood vessel itself using an intravascular probe attached to a device that includes an imaging element placed within the blood vessel. Several types of device systems are designed to track through the vasculature to provide intravascular image data. These can 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 attached to an intravascular device that includes an imaging element is moved along the blood vessel in the area where imaging is desired. As the probe passes through the area of ​​interest, a set of intravascular image data is obtained that corresponds to a series of "slices" or cross sections of the blood vessel, lumen, and surrounding tissue. These devices may include radiopaque materials or markers. Such markers are typically placed near the distal tip or near or on the probe. Thus, the approximate location of the imaging probe or imaging element can be identified by observing the procedure with either a fluoroscope 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. The raw image data is received by the console, processed to render an image including the features of interest, and rendered on a display device. Intravascular imaging data of blood vessels can provide useful information about the blood vessels that is different from, or in addition to, information provided by extravascular imaging data.For example, intravascular imaging data may provide data regarding the cross-section of the lumen, the thickness of deposits on the vessel wall, the diameter of the unaffected portion of the vessel, the length of the diseased section, the composition of deposits or plaque on the vessel wall, an assessment of plaque burden, or an assessment of stent deployment.

[0028] These two general types of imaging modalities provide different imaging data and thus may be complementary to each other. Thus, in certain circumstances, it may be desirable to provide or use both general types of medical imaging modalities to evaluate or treat a vessel. In addition, it may be useful for the locations of acquired intravascular imaging data / images to be correlated with their locations on a vascular roadmap obtained by extravascular imaging data / images. It may be useful to coordinate or "register" (e.g., co-register) imaging data rendered by two different modalities. It may also be useful to display the co-registered extravascular and intravascular imaging data together, for example, on a common display monitor. Some exemplary embodiments disclosed herein may include or relate to some or all of these aspects.

[0029] According to some embodiments of the present disclosure, exemplary methods, systems, devices, or software are described herein. These examples include image data acquisition equipment and data / image processors and associated software for acquiring and registering (e.g., co-registering) imaging data rendered by two separate imaging modalities (e.g., extravascular imaging data and intravascular imaging data). Additionally or alternatively, the exemplary methods, systems, or software may generate views on a single display that simultaneously provide extravascular images with position information and intravascular images associated with an imaging probe (e.g., an IVUS or OCT probe) attached to an intravascular device.

[0030] FIG. 1 is a schematic diagram of an exemplary system 102 that may be used in connection with performing embodiments of the present disclosure through acquiring and co-registering extravascular image data (e.g., angiogram / fluoroscopy) and intravascular image data (e.g., IVUS or OCT images). The system 102 may include an extravascular imaging system / subsystem 104 (e.g., an angiogram / fluoroscopy system) for acquiring / generating extravascular imaging data. The system 102 may 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 execute a method for vascular imaging registration of acquired extravascular imaging data and acquired intravascular imaging data.

[0031] The extravascular imaging data may be radiological image data acquired by an angiography / fluoroscopy system 104. Such angiography / fluoroscopy systems are generally known in the art. The angiography / fluoroscopy system 104 may include an angiography table 110, which may be positioned to provide sufficient space for placing an angiography / fluoroscopy unit C-arm 114 in an operative position relative to a patient 100 on the angiography table 110. The raw radiological image data acquired by the angiography / fluoroscopy C-arm 114 may be passed 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 part of a computer system / subsystem 130. The angiography / fluoroscopy input port 118 may include a processor that converts the raw radiological image data received thereby into extravascular image data (e.g., angiography / fluoroscopy image data), for example in the form of live video, DICOM, or a series of individual images. The extravascular image data may be initially stored in a memory in the input port 118 or may be stored in 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 entered into an input port of the computer 130. In some alternatives, communication between devices or processors may be performed via wireless communication rather than cables.

[0032] The intravascular imaging data may be, for example, IVUS data or OCT data acquired 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 may include an intravascular imaging device such as an imaging catheter 120, e.g., an IVUS or OCT catheter. The imaging device 120 is configured to be inserted into the patient 100 such that its distal end, including a diagnostic assembly or probe 122 (e.g., an IVUS or OCT probe), is in the vicinity of a desired imaging location of a blood vessel. A radiopaque material or marker 123 disposed on or near the probe 122 may provide an indicia of the current location of the probe 122 in a radiographic image.

[0033] As an example, for IVUS intravascular imaging data, the diagnostic probe 122 generates ultrasound waves and receives ultrasound echoes representative of an area proximate to the diagnostic probe 122. The probe 122 or catheter 120 can convert the ultrasound echoes into corresponding signals, such as electrical or optical signals. The corresponding signals are transmitted along the length of the imaging catheter 120 to a proximal connector 124. The proximal connector 124 of the catheter 120 is communicatively coupled to a processing unit or control module 126. IVUS versions of the probe 122 are provided in a variety of configurations, including single and multiple transducer element arrangements. It should be understood that in the context of IVUS, the transducers can be considered imaging elements. In the case of multiple transducer element arrangements, the array of transducers is potentially arranged linearly along the longitudinal axis of the imaging catheter 120, curvilinearly around the longitudinal axis of the catheter 120, circumferentially around the longitudinal axis, etc.

[0034] An example of an IVUS intravascular imaging catheter 120 is shown in FIGS. 2 and 3. The imaging catheter 120 may include an elongate shaft 170 having a proximal end region 172 and a distal end region 174. A proximal hub or connector 124 may be coupled to or otherwise disposed adjacent the proximal end region 172. A tip member 176 may be coupled to or otherwise disposed adjacent the distal end region 174. 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. Generally, the imaging assembly 177 (which may include an imaging probe 122 including an imaging element 182) may be used to capture / generate images of a blood vessel. In some examples, the medical device may include devices or features similar to those disclosed in U.S. Patent Application Publication Nos. 2012 / 0059241 and 2017 / 0164925, the entire disclosures of which are incorporated herein by reference. In at least some examples, the medical device 120 may be similar to or include similar features to the OPTICROSS™ imaging catheter available from BOSTON SCIENTIFIC (Marlborough, MA).

[0035] 3, the imaging assembly 177 may 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 may be coupled to the drive cable 178. The transducer 182 may be rotatable or axially translatable relative to the shaft 170. For example, the drive cable 178 may be rotated or translated to rotate or translate the transducer 182. The probe 122 or housing 180 may include or be made of, for example, a radiopaque material or marker 123, which may provide an indication of the current position of the probe 122 in a radiographic image.

[0036] Referring back to FIG. 1, as another example, the device 120 may be an OCT catheter used to collect OCT intravascular data. The OCT catheter 120 may include a diagnostic probe 122 that generates or propagates a light beam that is directed at the tissue, and some of this light that reflects off subsurface features is collected to represent the area proximate to the diagnostic probe 122. In OCT, the diagnostic probe 122 includes an optical imaging device for the delivery and collection of light. It should be understood that in the context of OCT, the optical imaging device of the probe 122 can be considered an imaging element. Using a technique called interferometry, the optical path length of the received photons can be recorded and most photons that are scattered multiple times before detection can be removed. Thus, OCT can build an image of a thick sample by removing background signals while collecting light that is directly reflected from the surface of the object. The probe 122 or catheter 120 may transmit an optical or light signal along its shaft, or may convert the light signal into a corresponding signal, such as an electrical or light signal, that can be transmitted along the length of the imaging catheter 120 to the proximal connector 124. The proximal connector 124 of the catheter 120 is communicatively coupled to a processing unit or control module 126. The probe 122 or housing 180 may include or be made of a radiopaque material or marker 123, which may provide an indication of the current position of the probe 122 in a radiological image.

[0037] Raw intravascular image data (e.g., raw IVUS or OCT data) may be acquired by the imaging catheter 120 and passed to the control module 126, for example, via the connector 124. The control module 126 may be a separate component or may be integrated into or part of the computer system / subsystem 130. The control module 126 may include a processor configured to convert or 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 live video, DICOM, or a series of individual images. The intravascular imaging data may include cross-sectional images of a vessel segment. In addition, the intravascular imaging data may include longitudinal cross-sectional images corresponding to slices of the vessel taken along the length of the vessel. The control module 126 may be considered an input port for the computer system / subsystem 130 or may be considered to be connected to an input port of the computer 130, for example, via a cable 119 or a wireless connection. The intravascular image data may be initially stored in a memory within the control module 126, or may 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 cable 119 and input to an input port of the computer 130. Alternatively, communication between devices or processors may be performed via wireless communication rather than cable 119.

[0038] The control module 126 may 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, 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, memory, a light source, an interferometer, an optical system, a motor drive unit, or a display. In some cases, the control module 126 may be or include a motor drive unit 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 components thereof. In some examples, 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 within a control / measurement object within the patient 100. Such an automated translation system may be used such that during a translation procedure, the imaging catheter 120 (including the imaging elements) is translated at a constant or known rate from a start position to an end position within the blood vessel (e.g., the imaging catheter 120 is translated at a particular rate for a known amount of time). In other embodiments, the translation may be performed manually. The translation procedure may be, for example, a "pullback" procedure (where the catheter 120 is pulled through the blood vessel) or a "push-through" procedure (where the catheter 120 is pushed through the blood vessel). The control module 126 may be comprised of or may include hardware and software configured to control intravascular imaging and data collection. For example, the control module 126 may include control features for turning on / off imaging or data collection from / to the catheter 120.

[0039] 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 is configured to acquire or obtain intravascular image data from or through the intravascular imaging system / subsystem 106 (e.g., IVUS or OCT) and to acquire extravascular image data from or through the extravascular imaging system / subsystem 104 (e.g., angiography / fluoroscopy system). The computer 130 or components thereof may include software and hardware designed to be incorporated into a standard catheterization procedure and to automatically acquire both extravascular imaging data (e.g., angiography / fluoroscopy) and intravascular imaging data (e.g., IVUS or OCT) through image or video acquisition.

[0040] The computer system / subsystem 130 or components thereof may include software or hardware configured to execute a method for vascular imaging coregistration of acquired extravascular imaging data and acquired intravascular imaging data. In that context, the computer 130 may include computer readable instructions or software for executing a method for vascular imaging coregistration as disclosed herein. For example, in some respects, the computer may include a processor or memory including software including program code that causes the computer to execute a method for vascular imaging coregistration as disclosed herein. For example, the computer / computing device may include a processor or memory including instructions executable by the processor to execute a method for vascular imaging coregistration as disclosed herein. In that context, it should also be understood that computer readable media 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 execute a method for vascular imaging coregistration as disclosed herein. Additionally, the computer / computing device 130 may be part of or include a system for intravascular imaging registration including one or more input ports for receiving imaging data, one or more output ports, and a controller in communication with the input and output ports, the controller configured to perform the method for intravascular imaging registration as disclosed herein.

[0041] The computer system / subsystem 130 may also include software and hardware configured to render or display imaging, including, for example, extravascular or intravascular imaging derived from the received image data or the co-registration method. In some cases, the computer 130 or software may be configured to render both extravascular and intravascular imaging on a single display. In this regard, the system may include a display 150 configured to simultaneously display extravascular 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, for example, via an output port on the computer 130 and a transmission cable 121. However, in some other cases, communication via the output port may be wireless rather than by cable. In some examples, the computer 130 or display 150 may be configured to simultaneously provide angiograms, IVUS transverse cross-sectional views, and IVUS longitudinal cross-sectional 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 cross-sectional view, and an OCT longitudinal cross-sectional view, which may or may not be co-registered.

[0042] 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.

[0043] The components of the system 102 may be used in concert during a vascular imaging method or procedure that involves the collection of extravascular and intravascular imaging data during a translational procedure. In the context of performing such a procedure and acquiring the necessary imaging data, an exemplary method for intravascular imaging registration may be performed or implemented.

[0044] For example, a patient 100 may be positioned on a table 110 for extravascular imaging of a portion of a blood vessel of interest. The patient 100 or the table may be positioned or adjusted to provide a desired view of the blood vessel of interest in preparation for collection of extravascular imaging data. In addition, an intravascular imaging catheter 120 may be introduced intravascularly into a portion of the blood vessel of interest in preparation for a translation procedure to collect intravascular imaging data. The intravascular imaging catheter 120 may be navigated and positioned within the blood vessel (often under fluoroscopy) such that the imaging element is located at a desired starting position for the translation procedure. A guide catheter may be used to assist with navigation. Once in the proper position, the translation procedure may be performed or implemented. Before or during the translation procedure, the necessary extravascular and intravascular imaging data may be acquired. In connection therewith, or as part of this process, an exemplary method for vascular imaging coregistration or registration may be performed or implemented.

[0045] Acquisition of extravascular imaging data One aspect of an exemplary method for vascular imaging coregistration includes acquiring extravascular imaging data of a portion of a blood vessel. One component of the acquired extravascular imaging data includes an extravascular image showing an intravascular imaging device positioned within the blood vessel. This can be represented by FIG. 4, which shows an angiography / fluoroscopy image 151 generated by angiography / fluoroscopy system 104, acquired by computer 130, and displayed on an image output 153 in the upper left portion of display 150. Image 151 may be part of a video stream or series of images displayed on the screen of display 150 at image output 153. Individually rendered frames may be tagged with appropriate tags (e.g., frame number, timestamp, sequence number, etc.) that may be useful for correlating image data frames. As shown, the acquired imaging data can include an extravascular image 151 showing an intravascular imaging device 120 positioned within a blood vessel 10 (blood vessel shown in dashed line) with an imaging element 182 of the intravascular imaging device 120 positioned at a start position 20 of a translation procedure (e.g., sometimes referred to as an "extravascular device image 151"). This extravascular device image 151 may be acquired and recorded under fluoroscopy, whereby radiopaque markers 123 on the device 120 can be used to identify / visualize the location of the imaging element 182 or the start position 20 of the imaging element 182. Since the start 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 positioned within the blood vessel 10 at a particular time, which can be useful during registration. As will be appreciated, image 151 may be acquired without contrast (e.g., under fluoroscopy) and therefore the anatomical structure of blood vessel 10 may be difficult to identify / visualize (which is why it is shown in dashed lines).

[0046] During the translation procedure, the imaging element 182 is translated from a start location 20 to an end location 30 within the blood vessel 10. This extravascular image 151 may also indicate an end location 30 of the translation procedure. For example, as described above, a guide catheter 190 including a distal end 191 may be used during the procedure. The distal end 191 may include a radiopaque material or marker and may be visualized or indicated on the acquired extravascular image 151 and used as an end location of the translation procedure. Since the end location 30 has been determined by identifying an actual location from the acquired angiography / fluoroscopy image 151, it is also an actual / known location within the blood vessel 10 and may also be useful during registration. In other embodiments, other reference points shown on the extravascular image 151 may be used to define the start or end location. For example, other devices, stents, anatomical markers, etc. shown on the extravascular image 151 may be used.

[0047] The acquired extravascular imaging data may also include an extravascular contrast image showing a portion of the blood vessel in contrast and showing one or more visualized anatomical landmarks. This may be represented, for example, by FIG. 5 showing an extravascular contrast image 251 (e.g., an angiogram taken with contrast agent in the blood vessel 10) generated by the angiography / fluoroscopy system 104, acquired by the computer 130, and displayed on the display 150 at the image output 153. The image 251 may be part of the same video stream or sequence of images as the device image 151 and may be displayed on the screen of the display at the image output 153. As shown, the acquired data may include an extravascular contrast image 251 showing a portion of the blood vessel 10 in contrast and showing one or more visualized anatomical landmarks (e.g., vascular side branches 12, 14, 16, 18). In this example, the one or more visualized landmarks include vascular side branches 12, 14, 16, 18, although other anatomical landmarks are contemplated and may be shown / used. Some examples of other visualized anatomical landmarks that may be shown / used may include identifiable changes in the size or shape of the blood vessel 10, such as stents, curvatures, stenosis, enlargement, or other identifiable anatomical landmarks that may be visualized on the extravascular contrast image 251.

[0048] The acquired extravascular imaging data may include video data including both the extravascular device image 151 (e.g., an image showing the starting position of the intravascular imaging device 120) and the extravascular contrast image 251 (e.g., a "roadmap"). In some cases, the extravascular device image 151 and the extravascular contrast image 251 may be separate individual images that may be combined or overlaid. These images may be acquired automatically by the system as part of a program that may be initiated by the user, or may be manually requested or acquired by a user interacting with the system, for example, through a user interface.

[0049] The order in which the extravascular imaging data is acquired may also vary. For example, as in the embodiment shown in Figures 4 and 5, the imaging device 120 may first be navigated to a desired starting position and an extravascular device image 151 (e.g., Figure 4) may be acquired first. An extravascular contrast image 251 (e.g., Figure 5) may then be acquired with the imaging device 120 already in or remaining in the vessel 10 when the contrast image 251 is taken. In other embodiments, it is contemplated that the order may be reversed. For example, the extravascular contrast image 251 may be acquired first with the intravascular imaging device not in the vessel 10. The imaging device 120 may then be navigated to a desired starting position and an extravascular device image 151 showing the device 120 in the starting position may be acquired. As will be appreciated, the extravascular imaging data may include one or both of angiographic image data and fluoroscopic image data. Additionally, as disclosed herein, the extravascular imaging data can be selected from one or more of two-dimensional angiography image data, three-dimensional angiography image data, or computed tomography angiography image data.

[0050] Acquisition of intravascular imaging data Another aspect of an exemplary method for vascular imaging coregistration includes acquiring intravascular imaging data from an intravascular imaging device during a translation procedure, the intravascular imaging data including one or more intravascular images showing one or more detected anatomical landmarks. This example can be represented / described with reference to FIGS. 6-8, which are a series of diagrams showing intravascular imaging data, each represented by a video or a series of intravascular images acquired during the progress of a translation procedure. The system may include software configured to initiate or perform or facilitate the translation procedure. The translation procedure may be initiated by a user interacting with the system, for example, via a user interface (e.g., clicking a "start pullback procedure" button to start the translation). Additionally, the translation procedure may be performed using an automated pullback system, for example, at a known speed, as discussed herein.

[0051] In this example, the translation procedure is a pullback, and the imaging element 182 is translated within the blood vessel from a start position 20 to an end position 30. As will be appreciated, in this example, the intravascular imaging data is intravascular ultrasound data (IVUS). However, as noted above, in other embodiments, the intravascular imaging data may be generated using other intravascular modalities, such as optical coherence tomography (OCT). The acquired intravascular imaging data in the form of a video or series of images includes one or more intravascular images showing one or more detected anatomical landmarks over the progression of the translation procedure. The individually rendered intravascular image frames may be tagged with appropriate tags (e.g., frame number, pullback distance, timestamp, sequence number, etc.) that may be useful, for example, to correlate the intravascular image frames with corresponding extravascular (e.g., radiopaque marker) image data frames, or to aid in correlating longitudinal cross-sectional intravascular images with transverse cross-sectional intravascular images. As will become apparent, in this example, the anatomical landmarks detected on the IVUS include the four side branches shown on the angiogram of this portion of the blood vessel (e.g., side branches 12, 14, 16, 18 on the angiogram of FIG. 5). However, other detected anatomical landmarks may be considered and shown / used. Some examples of other detected anatomical landmarks that may be used include identifiable changes in the size or shape of the blood vessel 10, such as stents, curvatures, stenosis, widening, etc., or other detectable anatomical landmarks that may be detected in one or more intravascular images acquired during the translation procedure.

[0052] Each of Figures 6-8 shows, at the bottom of the display 150, an on-screen image output 154 including intravascular imaging data including / representing a series of images generated by the intravascular imaging system / subsystem 106, acquired by the computer 130, and displayed on the display 150. As will be appreciated, the intravascular images shown on the image output 154 may include a number of longitudinal cross-sectional images corresponding to slices of the vessel taken along the length of the vessel during the translation procedure. The intravascular images shown on the image output 154 may be acquired during the translation procedure and recorded as part of a video or series of intravascular images. As the translation procedure progresses, the intravascular imaging data shown on the image output 154 may be gradually populated with additional intravascular images as they are generated. This is represented, for example, by viewing the progression / extension of the image output 154 from Figures 6 through 8, where additional intravascular images are gradually added to the intravascular imaging data 154 on the display 150 as the translation procedure progresses. One or more of these intravascular images show one or more detected anatomical landmarks (as described in further detail herein).

[0053] In addition, each of Figures 6-8 shows, in the upper right portion of the display 150, an on-screen image output 152 containing intravascular imaging data including / representing a series of cross-sectional images of a vessel segment. These cross-sectional images are generated by the intravascular imaging system / subsystem 106, included in the imaging data acquired by the computer 130, and displayed on the image output 152 on the display 150. These cross-sectional intravascular images shown on the image output 152 may be acquired progressively during the translation procedure and may be part of or recorded as an intravascular imaging video or a series of intravascular images. At any particular time during the translation procedure, the cross-sectional image shown on the image output 152 may correspond to the longitudinal cross-sectional image last added to the intravascular imaging output 154. In other words, a particular cross-sectional image displayed on the image output 152 and the corresponding longitudinal cross-sectional image simultaneously added to the end of the image output 154 may be different cross-sectional intravascular images / views, but taken at the same time / location within the vessel.

[0054] Intermediate extravascular imaging data may be optionally / periodically acquired during the translation procedure, for example to track the actual progress of the intravascular imaging device 120 during the translation procedure. These intermediate extravascular image(s) may be acquired during the translation procedure and may indicate the actual / known position of the intravascular imaging device 120 disposed within the vessel 10 with the imaging element disposed at an intermediate position during the translation procedure between the start position 20 and the end position 30. For example, periodically during the translation procedure, the angiography / fluoroscopy system 104 may be activated, either manually or automatically (e.g., fluoroscopy is activated) to generate one or more intermediate angiography / fluoroscopy images, which are acquired by the computer 130 and displayed at the time on the image output 153 on the display 150. In at least some embodiments, the translation procedure or the collection or co-registration method of 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 be performed without active 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 procedure.

[0055] Each of Figures 6-8 shows such intermediate / periodically acquired extravascular images in the upper left portion of image output 153 of display 150. As will be appreciated, such intermediate extravascular images show imaging elements 182 positioned at an actual / known intermediate location within blood vessel 10 at a particular time during the translation procedure. At a particular point during the translation procedure where an intermediate extravascular image is generated and shown in image output 153 on display 150, a corresponding longitudinal cross-sectional image for that particular intermediate location within blood vessel 10 is shown as the last image added to intravascular imaging output 153. Similarly, the transverse cross-sectional image shown in image output 152 at that time also corresponds to that particular intermediate location within blood vessel 10.

[0056] Briefly, the progression of Figures 6-8 is as follows: Figure 6 shows an intravascular image taken near the beginning of the translation procedure. Because it is early in the translation procedure, the image output 154 at the bottom of the screen is relatively short, showing the relatively few longitudinal cross-sectional intravascular images obtained so far in the translation procedure. In the upper right portion of the display 150, the image output 152 shows the corresponding intravascular cross-sectional image 252 of the vessel at this position. Figure 6 shows an intermediate extravascular image 351 at the image output 153 on the display 150. The intermediate extravascular image 351 can be obtained by briefly activating the fluoroscope and identifies the actual / known position of the intravascular imaging device 120 at this point in the translation procedure, which in this example shows an imaging element positioned closer to the start position 20 than the end position 30.

[0057] FIG. 7 shows an intravascular image taken near the middle of the translation procedure. The image output 154 at the bottom of the screen has increased (compared to FIG. 6) to show the addition of more longitudinal cross-sectional intravascular images obtained as the translation procedure progresses. It can also be seen that one or more of these intravascular images show one or more detected anatomical landmarks. In this case, the detected anatomical landmarks are the detected side branches of the blood vessel 10. In FIG. 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 may be automatically detected or marked by the system. For example, the computer 130 may include software or hardware configured to perform image processing and image recognition. Using the intravascular image data (e.g., IVUS data or other suitable data), the system may perform image processing and image recognition to identify or mark images that include the detected anatomical landmarks 197 / 198. In other cases, the images that include the detected anatomical landmarks may be manually identified or marked by a user, for example, via a user interface.

[0058] In the upper right portion of display 150 in Fig. 7, image output 152 shows a corresponding endovascular cross-sectional image 352 of the blood vessel at this position. Fig. 7 also shows a second intermediate extravascular image 451 at image output 153 on display 150. The intermediate extravascular image 451 can be acquired by briefly activating the fluoroscope and identifies the actual / known position of the endovascular imaging device 120 at this point in the translation procedure, which in this example shows an imaging element located approximately halfway between the start position 20 and the end position 30.

[0059] FIG. 8 shows an intravascular image taken as the translation procedure is nearing or has been completed. The image output 154 at the bottom of the screen has grown across the display (compared to FIGS. 6 and 7) to show the addition of many more longitudinal cross-sectional intravascular images acquired throughout the complete translation procedure (start to finish). It can also be seen that one or more of these intravascular images of the image output 154 on the display 150 show one or more detected anatomical landmarks (e.g., detected side branches of a vessel). In FIG. 8, the intravascular image showing the first two detected side branches is again marked with lines 197 and 198 (as in FIG. 7). Two additional intravascular images showing the third and fourth detected side branches are also acquired later in the translation procedure and are marked with lines 199 and 200. As described herein, images containing detected anatomical landmarks may be automatically identified or marked using, for example, image processing and image recognition, or may be manually identified or marked by a user via, for example, a user interface.

[0060] In the upper right portion of the display 150, the image output 152 shows a corresponding endovascular cross-sectional image 452 of the blood vessel corresponding to the end position within the blood vessel. FIG. 8 also shows an additional (e.g., third) intermediate extravascular image 551 at the image output 153 on the display 150. The extravascular image 551 can be acquired by briefly activating the fluoroscope to identify the actual / known position of the intravascular imaging device 120, which is shown with the imaging element 182 located at the end position 30 at the end of the translation procedure. At this point, the translation procedure can be stopped since the imaging element 182 has reached the end position 30. This may be done automatically by the system or manually by a user interacting with the system.

[0061] Marking one or more known locations on extravascular imaging data Another aspect of the exemplary method for vascular imaging co-registration includes marking the extravascular imaging data for registration. For example, the extravascular imaging data may be marked at actual / known registration points. For example, some embodiments include marking the start location 20 and / or end location 30 of the translation procedure on the extravascular imaging data.

[0062] For example, as described herein, the acquired extravascular imaging data also includes an extravascular image 151 (e.g., FIG. 4) and an extravascular contrast image 251 (e.g., FIG. 5). The extravascular image 151 is acquired under fluoroscopy and shows the start position 20 and / or end position 30 of the translation procedure, which were spotted and identified using the position or radiopaque markers of the device 120 / 190 identified under fluoroscopy. These are examples of actual / known positions or registration points. However, anatomical landmarks such as vessel lumen or side branches may not be easily identifiable / identifiable in the image 151 due to the absence of contrast flow (although they are shown in dashed lines in FIG. 4 for reference). On the other hand, the extravascular contrast image 251 (FIG. 5) is an angiogram with contrast, and thus shows a portion of the vessel in contrast and shows one or more visualized anatomical landmarks. Thus, visualized anatomical landmarks (e.g., side branches) can be identified on the extravascular contrast image 251. However, due to contrast, the location of the device or radiopaque markers of device 120 / 190 may be less discernible or identifiable in extravascular contrast image 251. This makes it difficult or impossible to see or identify actual / known locations or registration points, such as, for example, translation procedure start location 20 and end location 30. In some embodiments, it may be desirable to provide an image for marking or registration that includes data from both an extravascular image without contrast (e.g., fluoroscopy image 151) and an extravascular contrast image (e.g., contrast image 251).

[0063] In some embodiments, data from the extravascular image 151 showing actual / known positions or registration points, such as the start and end positions 20 and 30 of the translation procedure, may be combined with or overlaid on the extravascular contrast image 251. In some cases, this 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 designed to combine or overlay data in the images. In other cases, the images may be combined or overlaid manually by a user, for example, via a user interface.

[0064] The result of combining or overlaying data from an extravascular image 151 (e.g., a fluoroscopy image) with data from an extravascular contrast image 251 (e.g., an angiogram with contrast) can result in a combined or enhanced extravascular image 651 (e.g., an enhanced angiogram), which is extravascular imaging data that has been or can be marked. An example of such an extravascular image 651 is shown in FIG. 9, which shows an extravascular image 651 generated by computer 130 and displayed on image output 153 in the upper left portion of display 150.

[0065] As can be seen from FIG. 9, the start location 20 or end location 30 (e.g., actual / known location or registration point) may be identified on the extravascular image 651 and marked on the extravascular imaging data. For example, the start location 20 may be marked with a marker 620 on the extravascular image 651. The end location 30 may be marked with a marker 630 on the extravascular image 651. In some cases, this 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 the start location 20 or end location 30 (or other actual / known location or registration point). In other cases, the marking of the start location 20 or end location 30 (or other actual / known location or registration point) is performed manually by a user, for example, via a user interface.

[0066] Other extravascular data or images including or indicative of other actual / known positions of the imaging elements of the intravascular imaging device 120 during the translation procedure may be combined with or overlaid on the extravascular contrast image 251 or extravascular image 651. Other extravascular images, such as, for example, intermediate extravascular image 351 (FIG. 6) or intermediate extravascular image 451 (FIG. 7) or intermediate extravascular image 551 (FIG. 8), are also acquired under fluoroscopy during the translation procedure, each including the actual / known positions (by radiopaque markers 123) of the imaging elements 182 of the intravascular imaging device 120 at some point during the translation procedure. Combining or overlaying data from one or more of these additional extravascular images with the contrast image 251 or extravascular image 651 can add additional reference points and may help to increase accuracy. The process of combining or overlaying data may be performed, for example, automatically by the system or manually by the user, as described above. In addition, the specific actual / known position(s) of the imaging element 182 may be marked on the extravascular imaging data, the marking occurring in a similar manner as discussed above.

[0067] 9 also shows intravascular images taken as the translation procedure nears or ends. Image output 154 at the bottom of the screen shows longitudinal cross-sectional intravascular images acquired during the translation procedure (from start to finish). Image output 154 includes an intravascular image showing four detected anatomical landmarks (e.g., side branches), which are marked with lines 197, 198, 199, and 200, respectively. In the upper right portion of display 150, image output 152 shows a corresponding intravascular cross-sectional image 552 of the vessel corresponding to the intravascular end location.

[0068] As described herein, at least a portion of the translation procedure during collection of intravascular images may be performed or carried out without continuous angiography / fluoroscopy. In other words, the angiography / fluoroscopy system 104 may not be activated during the translation procedure or may be activated only periodically, for example to obtain an actual / known position. However, significant portions or periods may be carried out without angiography / fluoroscopy. In such cases, the actual / known position of the intravascular imaging device 120 is not tracked continuously under angiography / fluoroscopy during the translation procedure.

[0069] In embodiments in which angiography / fluoroscopy is inactive during significant portions of the translation procedure, the system may be configured to calculate an approximate or predicted position (e.g., by radiopaque markers 123) of the imaging element 182 for those portions of the translation procedure when angiography / fluoroscopy is inactive. For example, such calculations may be based on its last registered position / location (e.g., the last registered actual / known position of the imaging element 182) as well as other indicators of catheter movement or position, such as known pullback distance and velocity, calculated path, or other non-visual position data.

[0070] For example, if the initial position of the imaging element 182 is known (e.g., through one or more actual / known positions or registration points, such as the start position 20, the end position 30, or one of the intermediate positions acquired during the translation procedure), and the catheter 120 is pulled by an automated pullback system at a particular speed for a known amount of time, the calculated / predicted position is the distance from the initial position along the travel path, represented by the product of the pullback speed and the time. The computer 130 or components thereof may include software or hardware designed to perform such calculations and output the results, e.g., to indicate 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 procedure may be superimposed on the extravascular image 651 or a co-registered image as shown in FIG. 18, to represent the calculated / predicted position of the probe 122 or imaging element 182 at that point in the translation procedure.

[0071] In some embodiments, a calculated path (e.g., a calculated travel path) taken by the imaging element 182 during the translation procedure may be determined or used or displayed. For example, the predicted / calculated path may extend between the start location 20 and the end location 30 and may generally extend along the imaged vascular lumen shown on the extravascular contrast imaging data. Data regarding the calculated path may also be used or considered when calculating the approximate or predicted position of the imaging element 182. Some examples of methods that may be used to determine the calculated path include user-specified points or manual routing, image pattern recognition, automatic 2D and 3D path calculation, user-assisted automatic path calculation, and a combination of manual and automatic calculation of the path. The computer 130 or components thereof may include software or hardware designed to perform or facilitate such calculations and output the results, e.g., to indicate or mark the calculated path on a displayed image, as appropriate. For example, the calculated path may be overlaid on an extravascular image 651 or a co-registered image such as that shown in FIG. 18, which can represent the projected path of the probe 122 or imaging element 182 during the translation procedure.

[0072] As will be appreciated, there may be errors between the calculated / predicted positions and the actual / known positions. For example, it is expected that in certain periods when fluoroscopy is inactive, foreshortening issues may exist, which may cause errors between the calculated / predicted positions and the actual / known positions, especially in tortuous / curved vessels. However, at each subsequent time when the fluoroscope is activated and actual / known position data is acquired and presented to the processor, the errors between the actual / known positions and the predicted / calculated positions may be reduced or eliminated by replacing the calculated / predicted positions with the actual / known positions. In addition, another aspect of the exemplary method for vascular imaging co-registration disclosed herein includes aligning the predicted positions of certain detected anatomical landmarks with corresponding visualized anatomical landmarks, as described in more detail below. This aspect may also help to mitigate or reduce errors / misregistrations.

[0073] Marking the predicted locations of detected anatomical landmarks on extravascular imaging data Another aspect of an exemplary method for vascular imaging co-registration includes marking a predicted location of the detected anatomical landmark(s) on the extravascular imaging data. The intravascular imaging data acquired during the translation procedure includes one or more intravascular images showing one or more detected anatomical landmarks. As will 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 procedure. For the purpose of co-registration, the locations of these detected anatomical landmarks (e.g., from IVUS or OCT data) are 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 (either actual / known location or calculated / predicted location) of the imaging elements 182 of the intravascular imaging device 120 upon detecting a particular detected anatomical landmark during the translation procedure, 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).

[0074] In certain situations where an extravascular imaging device (angiography / fluoroscopy) is active at the same time that imaging element 182 detects a particular detected anatomical landmark, the location of the detected anatomical landmark is an actual / known location, and the location of that particular detected anatomical landmark can be marked and / or registered to its location on the extravascular imaging data using the actual / known location provided by the extravascular imaging.

[0075] However, as described herein, at least some, if not most or all, of the translation procedure when the intravascular images are collected is performed without subsequent extravascular imaging (e.g., without angiography / fluoroscopy). In such cases, the actual / known positions of the imaging elements 182 on the intravascular imaging device 120 when detecting a particular detected anatomical landmark during the translation procedure are not known. Thus, the calculated / predicted positions of the imaging elements 182 on the intravascular imaging device 120 when detecting a particular detected anatomical landmark during the translation procedure are used. Methods and / or systems for determining the calculated / predicted positions of the imaging elements 182 have been described above and can be used in this context. The predicted positions of the detected anatomical landmarks are then marked on the extravascular imaging data.

[0076] For example, FIG. 10 shows extravascular imaging data, in this case extravascular image 751, which can be created in a similar manner as the extravascular image 651 of FIG. 9 and is similar in morphology and function. The extravascular image 751 shows visualized anatomical landmarks, in this case side branches 12, 14, 16, and 18. In addition, a predicted location of the detected anatomical landmark 197 (e.g., the first side branch) from the intravascular image 154 has been calculated / predicted (as described herein). The predicted location of the detected anatomical landmark 197 is then marked with a marker arrow 212 on the extravascular imaging data (e.g., extravascular image 751). As can be seen, in this example, there is some misalignment / error / mismatch between the predicted and marked location 212 for the first side branch and the visualized anatomical landmark 12 on the extravascular imaging data.

[0077] It should also be noted that in the extravascular image 751, the visualized anatomical landmarks (e.g., side branches) are and / or can be identified manually or by the system. In some embodiments, the visualized anatomical landmarks (e.g., side branches 12, 14, 16, 18) may simply be manually identified by the user, e.g., by the user evaluating the image on a screen. In some embodiments, the visualized anatomical landmarks (e.g., side branches 12, 14, 16, 18) may be automatically identified by the system. For example, the computer 130 may 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).

[0078] The visualized anatomical landmarks may be marked on the extravascular imaging data. For example, the visualized anatomical landmarks (e.g., side branches 12, 14, 16, 18) may be marked with appropriate markers and / or labels on the extravascular image 751. In this case, the side branch 12 is marked as SB1, the side branch 14 is marked as SB2, the side branch 16 is marked as SB3, and the side branch 18 is marked as SB4. In some cases, this 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 the visualized anatomical landmarks. In other cases, marking the visualized anatomical landmarks may be performed manually by a user, for example, via a user interface.

[0079] 10 also shows intravascular images taken during the translation procedure. The image output 154 at the bottom of the screen shows the longitudinal cross-sectional intravascular images acquired during the translation procedure (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 as elsewhere herein and then marked with lines 197, 198, 199, and 200. Here, it will be understood that the lines 197, 198, 199, and 200 also have labels and / or flags. In particular, the line 197 is labeled SB1, the line 198 is labeled SB2, the line 199 is labeled SB3, and the line 200 is labeled SB4. The markings / text / symbols on the labels showing the four detected anatomical landmarks (e.g., side branches detected on IVUS) match the markings / text / symbols on the labels given to the corresponding visualized anatomical landmarks (e.g., side branches detected on angiograms). In addition, each of the detected anatomical landmarks also has an additional label showing a small representation of the corresponding endovascular cross-sectional image for that particular detected anatomical landmark. These small images of the corresponding endovascular cross-sectional image can be seen above each text label for each detected anatomical landmark. In some cases, these markings / labels may be applied 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 / label the landmarks accordingly. In other cases, the marking / labeling may be done manually by a user, for example, via a user interface.

[0080] In some cases, these lines / markings / labels may be interactive. For example, via a user interface, a user may actuate one of the lines / markings / labels, which may be highlighted and / or activated. When a line / marking / label for a particular detected anatomical landmark is highlighted or activated, the corresponding marked predicted location for that particular detected anatomical landmark is shown on the extravascular imaging data (e.g., extravascular image 751) and the corresponding endovascular cross-sectional image for that particular detected anatomical landmark is shown in the image output 152 in the upper right portion of the display 150.

[0081] 10, the label SB1 (designating the detected anatomical landmark 197) is shown activated / highlighted, as represented by the downward arrow above the label. A marker arrow 212 designating the predicted location of the detected anatomical landmark 197 on the extravascular imaging data is then shown on the extravascular image 751. And a corresponding endovascular cross-sectional image for the detected anatomical landmark 197 is shown in the image output 152. Each of the other labels may be similarly activated to indicate corresponding information.

[0082] Alignment of predicted positions of detected anatomical landmarks with visualized anatomical landmarks Another aspect of the exemplary method for vascular imaging co-registration includes aligning predicted positions of detected anatomical landmarks with visualized anatomical landmarks.

[0083] As described herein, the visualized anatomical landmark(s) are identified and / or identifiable on the extravascular imaging data, either manually or automatically by the system. The visualized anatomical landmarks may optionally be marked on the extravascular imaging data, either manually or automatically by the system. Additionally, the predicted location(s) of the detected anatomical landmark(s) may be calculated and marked on the extravascular imaging data, either manually or automatically by the system. However, as described herein, there may be some misregistration / error / mismatch between the predicted marked location(s) of the detected anatomical landmark(s) on the extravascular imaging data and the corresponding visualized anatomical landmark on the extravascular imaging data. The disclosed method for vascular imaging co-registration may include aligning the predicted location(s) of the detected anatomical landmark(s) with the visualized anatomical landmark, which may help to mitigate this misregistration / error / mismatch.

[0084] For example, FIG. 10 shows a display including extravascular imaging data, in this case an extravascular image 751 showing a visualized anatomical landmark 12. The landmark 12 is identified on the extravascular image 751 and labeled as SB1 (e.g., side branch 1). In addition, a predicted location of the detected anatomical landmark 197 (also labeled as SB1) from the intravascular image 154 is calculated / predicted and marked with a marker arrow 212 on the extravascular image 751. As will be appreciated, there will be some misalignment / error / mismatch between the predicted location 212 relative to 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 location 212 with the visualized anatomical landmark 12. The alignment is typically performed by moving or dragging an indicator representing the predicted location 212 on the screen so that it is aligned with the visualized anatomical landmark 12. In some cases, this alignment process may be performed automatically by the system. For example, the computer 130 may include software or hardware configured to automatically align the predicted location 212 with the corresponding visualized anatomical landmark 12. This may be done at the direction of a user or may be done automatically if a misalignment is detected. In other cases, the alignment may be done manually by a user, for example, via a user interface. Some examples of manual alignment may include the use of interactive labels as described above. For example, via a user interface, a user may highlight / activate a label that corresponds to a detected anatomical landmark of interest, in this case the detected anatomical landmark 197 labeled SB1. Once the label of the detected anatomical landmark is highlighted / activated, the corresponding marked predicted location of that particular detected anatomical landmark is shown on the extravascular imaging data, in this case a marker arrow 212 designates the predicted location of the detected anatomical landmark 197.The user can then manually move / drag the marker 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, thereby saving the alignment. FIG. 11 shows the screen with the same imaging data as shown in FIG. 10, but after aligning the predicted position 212 with the visualized anatomical landmark 12.

[0085] Similar registration steps can be performed for additional detected anatomical landmarks and any other predicted locations of the corresponding misaligned visualized anatomical landmarks.

[0086] For example, FIG. 12 shows a display including extravascular imaging data, in this case extravascular image 851, which is essentially the same as extravascular image 751, but with a focus on the visualized anatomical landmark 14 and the corresponding predicted location of the detected anatomical landmark 198. The landmark 14 is identified on the extravascular image 851 and labeled as SB2 (e.g., side branch 2). In addition, the predicted location of the detected anatomical landmark 198 (also labeled as SB2) from the intravascular image 154 is calculated / predicted and marked with a marker arrow 214 on the extravascular imaging image 851. As will be appreciated, there will be some misalignment / error / mismatch between the predicted location 214 relative to 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 location 214 with the visualized anatomical landmark 14 in a manner similar to that described above for aligning the predicted location 212 with the visualized anatomical landmark 12. FIG. 13 shows a view with the same imaging data as shown in FIG. 12, but after aligning the predicted location 214 with the visualized anatomical landmarks 14.

[0087] Similarly, FIG. 14 shows a display including extravascular imaging data, in this case extravascular image 951, which is essentially the same as extravascular images 751 and 851, but focusing on the corresponding predicted locations of the visualized anatomical landmarks 16 and the detected anatomical landmarks 199. The landmarks 16 are identified on the extravascular image 951 and labeled as SB3 (e.g., side branch 3). In addition, the predicted location of the detected anatomical landmarks 199 (also labeled as SB3) from the intravascular image 154 is calculated / predicted and marked with a marker arrow 216 on the extravascular imaging image 951. As will be appreciated, there is some misalignment / error / mismatch between the predicted location 216 relative to the detected anatomical landmarks and the identified visualized anatomical landmarks 16 on the extravascular imaging data. The methods and systems disclosed herein also provide for aligning the predicted location 216 with the visualized anatomical landmarks 16 in a manner similar to that described above for aligning the predicted location 212 with the visualized anatomical landmarks 12. FIG. 15 shows a view with the same imaging data as shown in FIG. 14, but after aligning the predicted location 216 with the visualized anatomical landmarks 16.

[0088] Similarly, FIG. 16 shows a display including extravascular imaging data, in this case extravascular image 1051, which is essentially the same as extravascular images 751, 851, and 951, but focusing on the visualized anatomical landmark 18 and the corresponding predicted location 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). In addition, the predicted location of the detected anatomical landmark 200 (also labeled as SB4) from the intravascular image 154 is calculated / predicted and marked with a marker arrow 218 on the extravascular imaging image 1051. As can be seen, there is some misalignment / error / discrepancy between the predicted location 218 for 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 location 218 with the visualized anatomical landmarks 18 in a manner similar to that described above for aligning the predicted location 212 with the visualized anatomical landmarks 12. Figure 17 shows a view having the same imaging data as shown in Figure 16, but after aligning the predicted location 218 with the visualized anatomical landmarks 18.

[0089] As a result of the methods and / or systems described herein, intravascular images generated by an intravascular catheter during a translation procedure are co-registered to an extravascular image, whereby every intravascular image (e.g., IVUS or OCT image) is linked to its corresponding location on the extravascular image (e.g., angiogram image). The resulting co-registered images can be used to render and present a co-registered display including both the extravascular image and the corresponding intravascular image. The co-registered extravascular and intravascular images can be simultaneously displayed alongside one another on the display 150. The co-registered image data may be stored on the computer 130 or long-term storage device 131 for later review, e.g., in a separate session from the procedure in which the extravascular and intravascular image data were acquired. The co-registered display may be rendered in a playback mode.

[0090] 18 shows an example of such a resulting co-registered display including both extravascular and corresponding intravascular images. As will be appreciated, the co-registered extravascular and intravascular images can be simultaneously displayed alongside one another on the display 150. For example, the display 150 includes an image output 153 in the upper left portion for showing the co-registered extravascular imaging data, an image output 154 along the bottom for showing co-registered longitudinal cross-sectional intravascular images acquired during the translation procedure (e.g., from start to finish), and an image output 152 in the upper right portion for showing corresponding co-registered transverse cross-sectional intravascular images acquired during the translation procedure.

[0091] In some embodiments, the system may include software or hardware configured to allow a user to scroll and / or track a series of coregiven images. For example, the system may include configurations that allow a user to scroll through one of the sets of coregiven images, and as scrolling occurs, the processor acquires and displays corresponding coregiven images for the other set of images. For example, with reference to FIG. 18, a slider bar / cursor 600 may be displayed / overlaid on the image output 154 showing a series of intravascular images acquired during a translation procedure. Additionally, a corresponding slider bar / cursor 602 may be displayed on the image output 153 along 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., calculated path) of the vessel on the coregiven extravascular image shown on the image output 153, the bar / cursor 600 slides accordingly along the corresponding / coregiven image shown on the image output 154. Similarly, when the user selects and drags the slider bar / cursor 600 along the co-registered image shown on 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 on image output 153. In addition, as the user moves either of the bars / cursors 600 / 602, a corresponding cross-sectional image of the vessel segment is displayed on the on-screen image output 152.

[0092] Another aspect of the method for vascular imaging coregistration may include estimating the accuracy of the imaging registration. As described herein, there may be some misregistration / error / mismatch between the predicted marked location(s) of the detected anatomical landmark(s) on the extravascular imaging data and the corresponding visualized anatomical landmark on the extravascular imaging data. As disclosed herein, one aspect of the method for vascular imaging coregistration may include aligning the predicted location(s) of the detected anatomical landmark with the visualized anatomical landmark, which may help to mitigate some of this misregistration / error / mismatch in the coregistration. However, the fact that this misregistration / error / mismatch occurred in the first place (e.g., before aligning the predicted location(s) of the detected anatomical landmark with the visualized anatomical landmark) suggests a desire to estimate the accuracy of the image coregistration, and in some cases a mechanism for doing so may be provided. The system may include software or hardware configured to estimate the accuracy of the coregistration, and in some cases to display and / or otherwise indicate the estimated accuracy level for some or all of the coregistration.

[0093] Various methods can be used to estimate the accuracy of the co-registration. For example, the errors between the predicted locations of the detected anatomical landmarks and the corresponding visualized anatomical landmarks can be measured individually, in groups, or as a whole across the entire co-registration. The magnitude of these measurements can indicate an estimated level of accuracy for some or all of the co-registrations. For example, if the magnitude of the measured errors is large and / or exceeds some predefined threshold, the predicted level of accuracy for the co-registration can be low. On the other hand, if the magnitude of these measurements is large and / or exceeds some predefined threshold, the predicted level of accuracy for the co-registration can be low. These estimates of accuracy can be made for some or all of the co-registrations. Other exemplary factors that may be used in estimating the accuracy of the coregistration may include the total number of actual / known positions or registration points used in the coregistration (e.g., obtained via fluoroscopy), the distance between the actual / known positions or registration points, the total number of registrations performed (e.g., alignment of predicted positions of detected anatomical landmarks with visualized anatomical landmarks), the distance between the registrations performed, and the tortuosity of the vessel being analyzed. Other methods of estimating accuracy may include using curve-based algorithms or formulas, foreshortening prediction formulas or models, and the like.

[0094] The estimated level of accuracy of the coregistration may be performed for all or a portion of the coregistration and / or across all or a segment of the portion of the vessel being analyzed. Once the estimated level of accuracy is determined, the estimated level of accuracy for all or a portion of the coregistration is displayed. For example, the system may include software or hardware configured to generate a visual indicator representing the estimated accuracy of the imaging coregistration. In some embodiments, the visual indicator may be displayed and / or overlaid on all or a portion of the vessel shown on the extravascular imaging data. The visual characteristics may include color, symbol, intensity, etc., and may be overlaid / superimposed on or associated with a segment of the vessel shown. In some cases, different colors, symbols, intensity levels may be coded and / or used to indicate the level of accuracy. For example, if the level of accuracy is determined to be high for a particular segment, one color (e.g., green) may be overlaid on that segment. Alternatively, if the level of accuracy is determined to be low for another particular segment, another color (e.g., red) may be overlaid on that segment. As will be appreciated, these are given by way of example only, and a wide range of other configurations are contemplated.

[0095] In another aspect, it can be appreciated that there may be an error between the actual / known position and the calculated position, and this error may be determined or measured. In some embodiments, this error may be used to adjust the co-registration to account for it. For example, the error / total distance traveled ratio may be used as a scaling factor to recalculate and adjust previously calculated / predicted positions on extravascular images (e.g., angiograms) over a preceding period when the fluoroscope was inactive.

[0096] In some examples, it may be beneficial to use the co-registered intravascular and extravascular imaging data in determining a location of interest for performing a subsequent medical procedure or analysis. The location of interest may indicate, for example, a specific location within a particular blood vessel. The location of interest may define a specific start point and a specific end point (e.g., an area) within a particular blood vessel for performing a particular medical procedure or analysis. In analyzing the co-registered intravascular and extravascular imaging data to determine the location of interest, a physician or other professional may drop one or more markers or bookmarks on the co-registered intravascular and extravascular imaging data to subsequently identify the location of interest, as described below.

[0097] Examples of subsequent medical procedures or analyses include, but are not limited to, angioplasty, atherectomy and / or stenting, physiological measurements such as pressure measurements including FFR (fractional flow reserve) measurements, iFR (instantaneous fractional flow reserve) measurements, DFR (diastolic resting coronary pressure ratio) measurements, and the like. The co-registered intravascular and extravascular imaging data can be used in guiding other diagnostic procedures such as diagnostic angiography and coronary physiology testing, but are not limited to this. The co-registered intravascular and extravascular imaging data can be useful in reducing the amount of x-ray contrast used because a physician or other professional does not need to inject contrast to confirm a location of interest. In some examples, for example, a physician or other professional can analyze the intravascular imaging data, the extravascular imaging data, and the co-registration between the intravascular and extravascular imaging data (e.g., the co-registered image data) to determine an appropriate location within a patient's blood vessel for performing a subsequent medical procedure or analysis.

[0098] This may include, for example, having the patient visit a catheterization lab, such as that shown in system 102 of FIG. 1, to acquire and coregist extravascular image data (e.g., angiography / fluoroscopy) and intravascular image data (e.g., IVUS or OCT images) as described herein. A physician or other specialist can then analyze 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 specialist determines that the patient is a candidate for stent placement, the physician or other specialist can use the coregistrated data to determine where to place the stent, thereby determining the location of interest. If the physician or other specialist determines that the patient is a candidate for balloon angioplasty, for example, the physician or other specialist can use the coregistrated data to determine precisely where balloon angioplasty should be performed, thereby determining the location of interest. If a physician or other specialist determines that a patient is a candidate for rotational atherectomy, the physician or other specialist can use the coregistered data to identify the location of plaque that needs to be removed, thereby determining a location of interest. If a physician or other specialist determines that a patient is a candidate for performing a particular medical procedure or analysis on the patient, the physician or other specialist can use the coregistered data to determine one or more locations within the blood vessel for performing the particular medical procedure or analysis, thereby determining one or more locations of interest.

[0099] Once a physician or other specialist has analyzed the coregiZed data and determined a course of treatment for a particular patient, the physician or other specialist may refer the patient back to the catheterization lab for further treatment. FIGURE 19 is a diagram of a catheterization lab 240. The catheterization lab 240 may be similar to the system 102 illustrated in FIGURE 1, but in this case, it houses an endovascular subsystem 106 that includes an endovascular imaging device, such as an imaging catheter 120. The catheterization lab 240 may include additional equipment (not shown) for performing any of a variety of different catheter-based interventions, such as stenting, balloon angioplasty, balloon cutting, atherectomy, and others.

[0100] In some examples, once the physician or other specialist has determined a course of treatment for the patient, including determining what medical procedure should be performed and the general and / or exact location within the vessel where that procedure should be performed, thereby determining a location of interest, the physician or other specialist can drop one or more bookmarks or markers onto the coregiven data to mark the location of interest. The coregiven data may be stored within the IVUS control unit 126, computer 130 or data archive or memory 131, while the coregiven data, or at least a portion thereof, may be transmitted to the display 150 to be displayed for viewing by the physician or other specialist. In some cases, the coregiven data may be displayed on a display that is part of an extravascular imaging system, such as, for example, a fluoroscopy system.

[0101] In some examples, extravascular imaging data of a portion of a blood vessel may be acquired, the extravascular imaging data including an extravascular image showing an intravascular imaging device positioned within the blood vessel, with an imaging element of the intravascular imaging device positioned at a start position for a translation procedure in which the imaging element is translated within the blood vessel from a start position to an end position. An extravascular contrast image showing the portion of the blood vessel in contrast and showing the visualized anatomical landmarks is acquired. Intravascular imaging data is acquired from the intravascular imaging device during the translation procedure, the intravascular imaging data including one or more intravascular images showing the 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 described herein. A location of interest within the blood vessel between the start position and the end position may then be determined and displayed on the live fluoroscopy session display. Determining the location of interest may include dropping one or more markers or bookmarks on the co-registered intravascular and extravascular imaging data. Displaying the location of interest on the live fluoroscopy display may include, for example, displaying one or more markers or bookmarks.

[0102] In some cases, a method for determining a position for performing a medical procedure includes acquiring extravascular imaging data of a portion of a blood vessel, the extravascular imaging data including an extravascular image indicating a start position and an end position for a translation procedure in which an intravascular imaging element is translated within the blood vessel from a start position to an end position. The intravascular imaging data is acquired from an intravascular imaging device during the translation procedure. The intravascular imaging data is co-registered with the extravascular imaging data to create co-registered imaging data. The data may be co-registered, for example, using any of the co-registration methods described herein. In some cases, the co-registered intravascular and extravascular imaging data may be displayed. The co-registered imaging data is used to determine a position of interest within the portion of the blood vessel between the start position and the end position. The position of interest may be displayed, for example, on a live fluoroscopy session display.

[0103] In some examples, determining the location of interest in the blood vessel between the start and end locations may include automatically determining the location of interest based on intravascular imaging data. In some cases, this may include a process known as ALA (Automatic Lesion Assessment). Details and features regarding ALA are described, for example, in U.S. Patent Application No. 17 / 683,654 (filed March 1, 2022), U.S. Provisional Patent Application No. 63 / 233,875 (filed August 17, 2021), and U.S. Provisional Patent Application No. 63 / 253,881 (filed 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 the 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. In addition, the software or hardware may be configured to mark and / or label the location and / or places of interest accordingly.

[0104] In other cases, the determination and / or marking / labeling of the locations of interest may be performed manually by a user, for example, via a user interface. For example, the system software may enable a user to place marks and / or labels at desired locations on the image using the user interface. A physician or other professional may analyze the displayed co-registered intravascular and extravascular imaging data to manually identify one or more locations of interest. In some examples, a physician or other professional may manually mark one or more locations of interest. This may include the physician or other professional manually dropping one or more markers or bookmarks onto the displayed co-registered intravascular and extravascular imaging data.

[0105] In some examples, referring to FIG. 19 , displaying the location of interest on the live fluoroscopy display may include providing the location of interest to the live fluoroscope via a data link with the live fluoroscopy display. The data link may be embodied, for example, by a transmission cable 121. In some cases, the data link may be bidirectional, allowing communication in both directions. In some examples, a data security protocol may be implemented to ensure data integrity and ensure patient privacy. In some cases, at least some of the elements of the catheterization lab 240 (not including the computer 130 and data storage 131) may be remote from the catheterization lab 240. Thus, the data link may include a LAN (local area network) or a WAN (wide area network). In some cases, the data link may include the Internet.

[0106] 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, and / or stent placement. Examples of analyses that may be performed include physiological measurements such as pressure measurements including FFR (fractional flow reserve) measurements, iFR (instantaneous fractional flow reserve) measurements, DFR (diastolic resting free pressure ratio) measurements, and the like.

[0107] The method includes acquiring extravascular imaging data for a portion of a blood vessel and acquiring 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 live fluoroscopy session display. In some examples, determining the location of interest may include analyzing the co-registered intravascular and extravascular imaging data to determine one or more points of interest and dropping one or more markers or bookmarks on the co-registered intravascular and extravascular imaging data to indicate the location of interest. Displaying the location of interest on the live fluoroscopy display may include, for example, displaying the one or more markers or bookmarks.

[0108] Another example includes a method of determining a location of interest for placing a stent. The method includes acquiring extravascular imaging data for a portion of a blood vessel and acquiring intravascular imaging data for the same portion of the blood vessel. The intravascular imaging data is co-registered with the extravascular imaging data. A desired placement location for placing the stent is determined, thereby identifying a location of interest and displaying the location on a live fluoroscopy session display. In some examples, determining the location of interest for placing the stent may include analyzing the co-registered intravascular and extravascular imaging data to determine one or more points of interest and dropping one or more markers or bookmarks on the co-registered intravascular and extravascular imaging data to indicate the location of interest. In some examples, the points of interest may be determined automatically. In some cases, the points of interest may be determined manually. Displaying the location of interest on the live fluoroscopy display may include, for example, displaying one or more markers or bookmarks.

[0109] Alternatively or additionally, displaying the desired location of interest may include displaying one or more of a distal marker indicating a distal end of the location of interest and a proximal marker indicating a proximal end of the location of interest. The location of interest may be considered to extend between the distal marker and the proximal marker, for example. A particular blood vessel may have one, two or more locations of interest, each located along the blood vessel. In some cases, each of the locations of interest in the blood vessel may include a distal marker and a proximal marker. In some cases, the markers indicating each of the locations of interest may be uniquely colored, for example, to more easily see where a first location of interest is relative to a second location of interest. In some cases, each distal marker may share a first color and each proximal marker may share a second color. For example, each distal marker may be green and each proximal marker may be yellow. A person viewing the markers may identify the distal and proximal ends of each of the locations of interest.

[0110] In some cases, the location of interest may be displayed on live fluoroscopy in the intravascular imaging console via a real-time data connection from the fluoroscope. The display of the location of interest may be automatically synchronized to cardiac motion by using ECC gating. In some cases, the display of the location of interest may be automatically synchronized with motion analysis of radiopaque objects such as guide catheters or guidewires.

[0111] The location of interest or two or more locations of interest may each define a desired location for performing a medical procedure, such as balloon angiography, rotational atherectomy, etc. The location of interest may define, for example, a desired stent placement location. In some cases, a first location of interest in a particular vessel may be a candidate for a first medical procedure, and a second location of interest in the same vessel but spaced apart from the first location of interest may be a candidate for a second medical procedure. As an example, the first location of interest may be a candidate for rotational atherectomy, and the second location of interest may be a candidate for balloon angioplasty. In some cases, a location of interest may be a candidate for multiple medical procedures. As an example, a particular location of interest may be a candidate for either rotational atherectomy or balloon angioplasty, after which stent placement is performed to maintain the vascular patency achieved during the initial procedure to open the vessel. This is merely an example.

[0112] 20 is a schematic diagram of a display 250 showing an exemplary live fluoroscopic image 252. It will be appreciated that the live fluoroscopic image 252 is similar to the angiographic / fluoroscopic image 151 and shows the same portion of the same patient's vessel as previously captured in the co-registered image. The live fluoroscopic image 252 includes a marker 254 superimposed on a portion of a side branch 256. The marker 254 may be placed on the co-registered data by a physician or other professional, or may be placed automatically by the system, e.g., via ALA, and transferred to and superimposed on the live fluoroscopic image 252. In some instances, only a single marker 254 is needed. If only a single marker 254 is used, the marker 254 may indicate, for example, the distal end of a location of interest, such as a treatment site. The marker 254 may indicate, for example, where a distal end of a stent should be placed or where other treatment should be performed. Marker 254 may indicate the distal-most edge of the plaque to be removed by atherectomy, or indicate where the distal end of a balloon should be located prior to inflating the balloon to perform balloon angioplasty. These are merely examples, and other examples of vascular treatment possibilities are known and contemplated.

[0113] 21 is a schematic diagram of a display 250 showing an exemplary extravascular image, such as a live fluoroscopic image 258. The live fluoroscopic image 258 is similar to the live fluoroscopic image 252, but includes a marker 254 and a second marker 260 superimposed on the side branch 256. The marker 260 may be placed on the co-registered data by a physician or other professional (e.g., via a system user interface) or automatically, e.g., via the ALA, and is transferred to and superimposed on the live fluoroscopic image 258. It should be appreciated that the markers 254 and 260 may be combined to mark a location of interest, in this case the treatment zone between the markers 254 and 260. In some examples, the marker 254 may be considered to be, for example, a distal marker and the marker 260 may be considered to be a proximal marker.

[0114] If the patient is scheduled for stenting, marker 254 may indicate where the distal end of the stent should be placed, and marker 260 may correspondingly indicate where the proximal end of the stent may be located. The distance between markers 254 and 260 may indicate an area for performing any of a variety of other potential treatments, such as, for example, atherectomy, balloon angioplasty, cutting balloon therapy, physiological measurements, thrombectomy, additional imaging, or the like.

[0115] When viewing the co-registered intravascular and extravascular imaging data, the physician or other professional may drop additional bookmarks or other markers to indicate one or more additional locations and / or spots of interest. These may include areas where the physician or other professional is not sure whether or not a procedure is required, but would like to review again with live fluoroscopy or other imaging or examination techniques. The physician or other professional may drop a first marker or bookmark to indicate, for example, that a first location in the vessel requires a first type, style or size of stent, and a second location in the vessel requires a second type, style or size of stent. These markers or bookmarks may be placed either manually or automatically, in addition to the markers or bookmarks indicating the distal and proximal landing zones. Examples of reasons for placing additional markers or bookmarks that may be considered to be secondary markers or bookmarks (those indicating the distal and proximal landing zones are considered primary markers or bookmarks) include the location of calcium and the ends of the stent.

[0116] In some cases, it may be desirable to display live fluoroscopic data instead of or in addition to the co-registered data shown in, for example, FIG. 18. FIG. 22 is similar to FIG. 18, but the co-registered data shown in FIG. 18 has been replaced with a live fluoroscopic image 258. As shown, this allows a physician or other professional to view intravascular imaging data (IVUS data) on the screen simultaneously with the live fluoroscopic image 258. In some cases, depending on how the screen is laid out, the live fluoroscopic image 258 may be displayed next to or otherwise in combination with the previous angiography / fluoroscopic image 151.

[0117] 23 shows an example of such a resulting co-registered display including both an extravascular image and a corresponding intravascular image. As will be appreciated, the co-registered extravascular and intravascular images may be simultaneously displayed alongside one another on the display 150. For example, the display 150 includes an image output 153 in the upper left portion to show co-registered extravascular imaging data 262, an image output 154 along the bottom to generally show a co-registered longitudinal cross-sectional intravascular image 264 acquired during the translation procedure (e.g., from start to finish), and an image output 152 in the upper right portion to generally show a corresponding co-registered transverse cross-sectional intravascular image 266 acquired during the translation procedure.

[0118] In some examples, as shown, the image output 154 includes a stylized representation 268 of a portion of a blood vessel shown generally in the longitudinal cross-sectional intravascular image 264. As can be seen, the effective cross-sectional diameter of the blood vessel shown in the stylized representation 268 varies in response to changes in the anatomy of the blood vessel, including areas of plaque within the blood vessel. In some examples, the stylized representation 268 may include, for example, numerical markings indicating the effective diameter of the blood vessel at a particular location. In some embodiments, the system may include software or hardware configured to allow a user to scroll and / or track through a series of co-registered images. For example, the system may include configurations that allow a user to scroll through one of the sets of co-registered images, and as scrolling occurs, the processor retrieves and displays the corresponding co-registered image relative to the other set of images.

[0119] For example, referring to FIG. 23 , an interactive slider 270 may be superimposed on a stylized representation 268 of a blood vessel. The interactive slider 270 includes a first slide bar 272 that may be used to indicate a start point of a location of interest and a second slide bar 274 that may be used to indicate an end point of the location of interest. In some cases, the first slide bar 272 may 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 slide bar 274 may 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 places the first slide bar 272 and the second slide bar 274 where the interactive slider 270 would mark the location of interest, the system may allow the physician or other professional to indicate to the system that they would like to place markers or bookmarks at these locations. The first slide bar 272 may include a first cursor button 272a that allows a physician or other professional to move the first slide bar 272, for example, by touching and dragging the first cursor button 272a. In some cases, the physician or other professional may move the first slide bar 272 using, for example, a mouse or keyboard. The second slide bar 274 may include a second cursor button 274a that allows a 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 move the second slide bar 274 using, for example, a mouse or keyboard.

[0120] The interactive slider 270 includes a bar 280 that correlates the position of the first slide bar 272 relative to the schematic representation 268 with the coregistered longitudinal cross-sectional intravascular image 264. In some examples, the bar 280 includes a touch point 280a that can be used to move the position of the bar 280, similar to the first cursor 272a. Moving the bar 280 moves the first slide bar 272 as well. It will be appreciated that when the interactive slider 270 is manipulated, such as by moving the first slide bar 272, the coregistered transverse cross-sectional intravascular image 266 shown in the image output 154 changes to correspond to the indicated position within the coregistered longitudinal cross-sectional intravascular image 264 shown in the image output 152. In some cases, a corresponding slider indicator 288 may be displayed on the coregistered 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 indicates the point within the displayed portion of the vessel that has the minimum effective diameter. This may be a result of the vessel's native anatomy, or may indicate where accumulated plaque is narrowing the vessel.

[0121] Thus, the illustrated position of the interactive slider 270 may indicate a location of interest defined between the first slide bar 272 and the second slide bar 274. Similarly, the two corresponding markers 276 and 278 shown on the co-registered extravascular imaging data 262 may be considered to define a location of interest where a physician or other professional believes medical treatment or analysis is necessary. In some cases, as shown, the co-registered extravascular imaging data 262 may include a start point 284 and an end point 286. The start point 284 and the end point 286 may represent the start and end points, respectively, for the IVUS pullback that generated the displayed data. It will be appreciated that the start point 284 and the end point 286 may indicate the range within which a physician or other professional may view the co-registered intravascular and extravascular imaging data.

[0122] It will be understood that the present disclosure is in many respects merely illustrative. Changes may be made in details, particularly in matters of shape, size and arrangement of steps, without exceeding the scope of the present disclosure. This may include, to the extent appropriate, the use of any of the features of one illustrative embodiment used in another embodiment. The scope of the invention is, of course, defined in the language in which the appended claims are expressed.

Claims

1. 1. A method for determining a location of interest for performing a medical procedure, comprising: acquiring extravascular imaging data of a portion of a blood vessel, the extravascular imaging data comprising: acquiring the extravascular imaging data, the extravascular image including an extravascular image indicative of a start and end position for a translation procedure in which an intravascular imaging element is translated within a blood vessel from a start position to an end position; acquiring intravascular imaging data from an intravascular imaging device during the translation procedure; co-registering the intravascular imaging data with the extravascular imaging data to generate co-registered imaging data; determining a location of interest within a portion of a blood vessel between the start location and the end location using the co-registered imaging data; and displaying the location of interest on a live fluoroscopy session display.

2. The method of claim 1 , wherein determining an intravascular location of interest between the start location and the end location comprises automatically determining a location of interest based on the intravascular imaging data.

3. The method of claim 1 or 2, wherein displaying the location of interest on the live fluoroscopy session display includes using a real-time data connection from a fluoroscopy device.

4. 4. The method of claim 1, wherein displaying the location of interest on the live fluoroscopy session display further comprises automatically synchronizing the location of interest to cardiac motion via ECC gating.

5. 5. The method of claim 1, wherein displaying the location of interest on the live fluoroscopy session display further comprises automatically synchronizing the location of interest with a radiopaque object motion analysis.

6. The method of claim 1 , further comprising displaying the co-registered intravascular and extravascular imaging data.

7. 7. The method of claim 6, wherein determining an intravascular location of interest between the start location and the end location comprises analyzing the displayed co-registered intravascular and extravascular imaging data.

8. 8. The method of claim 1, wherein the medical procedure comprises placing a stent.

9. The method of claim 8 , wherein displaying the location of interest on a live fluoroscopy display includes displaying a distal marker indicating a target location of a distal end of the stent.

10. 10. The method of claim 8 or 9, wherein displaying the location of interest on a live fluoroscopy display further comprises displaying a proximal marker indicating a target location of a proximal end of the stent.

11. 11. The method of claim 1, wherein displaying the location of interest on a live fluoroscopy display further comprises providing the location of interest to a live fluoroscopy device via a data link with the live fluoroscopy display.

12. The method of claim 11 , wherein the data link comprises a bidirectional data link.

13. 13. The method of claim 1, further comprising transmitting data from the live fluoroscopic display to a display displaying the co-registered intravascular and extravascular imaging data.

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

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

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