WO2020148162A1

WO2020148162A1 - Intravascular imaging and pressure-sensing procedure case log with dynamic preview

Info

Publication number: WO2020148162A1
Application number: PCT/EP2020/050472
Authority: WO
Inventors: David Michael ANDERSON
Original assignee: Koninklijke Philips N.V.
Priority date: 2019-01-15
Filing date: 2020-01-10
Publication date: 2020-07-23

Abstract

Disclosed is an intravascular sensing system, comprising a processor circuit configured to be in communication with a display and an intravascular catheter or guidewire. The intravascular catheter or guidewire is configured to be positioned within a blood vessel of a patient and comprises a sensor configured, when positioned within the blood vessel, to obtain intravascular data comprising intravascular ultrasound (IVUS) imaging data and/or pressure data. The processor circuit is configured to receive the intravascular data from a plurality of intravascular measurements for a patient, and to receive a user input corresponding to the selection of one of the measurements. Based on the user input, the system will generate a screen display comprising a list of the intravascular measurements for the patient, and a visual representation of the intravascular data associated with the selected measurement, provided adjacent to the list of intravascular measurements.

Description

INTRAVASCULAR IMAGING AND PRESSURE-SENSING PROCEDURE

CASE LOG WITH DYNAMIC PREVIEW

TECHNICAL FIELD

[0001] The present disclosure relates generally to intravascular imaging and/or pressure sensing associated with a blood vessel of a patient. In particular, intravascular imaging and/or pressure data procedures and data from those procedures are associated in memory, retrieved, and displayed in a streamlined manner that allows a clinician to more efficiently review data from different modalities to make a clinical determination.

BACKGROUND

[0002] Various types of intravascular imaging systems and functional measurement systems are used in diagnosing and treating diseases. For example, intravascular ultrasound (IVTJS) imaging is widely used in interventional cardiology procedures as a diagnostic tool for visualizing vessels within a body of a patient. This may aid in assessing vessels, such as an arteries, veins, and other lumens within the human body to determine the need for treatment, to optimize treatment, and/or to assess its effectiveness.

[0003] In imaging analysis of the intravascular images, it may be useful to judge the severity of a lesion within the vessel or artery by generating and displaying measurements that correspond to landmarks. These landmarks may assist in treatment planning. However, because many frames may be analyzed, requiring a high level of expertise, this process can be time consuming and costly. Furthermore, existing intravascular image storage, retrieval, and display systems may lead to logistical and judgment errors because of confusion between the many frames that are analyzed, the difficulty in scrolling through the most relevant frames to identify a lesion, and confusion between different procedures performed on the same patient. Thus, deficiencies exist in current intravascular image storage, retrieval, augmentation and display systems.

[0004] Another currently accepted technique for assessing the severity of a stenosis in a blood vessel, including ischemia causing lesions, is fractional flow reserve (FFR). FFR is a calculation of the ratio of a distal pressure measurement (taken on the distal side of the stenosis during a procedure) relative to a proximal pressure measurement (taken on the proximal side of the stenosis, usually during the same procedure). FFR provides an index of stenosis severity that allows determination as to whether the blockage limits blood flow within the vessel to an extent that treatment is required. The normal value of FFR in a healthy vessel is 1.00, while values less than about 0.80 are generally deemed significant and require treatment. Still another accepted technique is instantaneous wave-free ratio (iFR) measurement. For some applications, FFR and/or iFR measurements are determined by performing image-processing on extraluminal images. At other times, FFR and/or iFR are computed by taking functional intravascular measurements (i.e., pressure measurements) both distal to and proximal to a lesion or stenosis.

[0005] This results in a variety of different data types, sometimes captured simultaneously, sometimes captured at different times during the same procedure, and sometimes captured during different procedures for the same patient. Clinical practitioners may treat a number of different patients over the same time period, leading to more sources of potential confusion and delay in retrieving the correct data.

SUMMARY

[0006] An intravascular system for generating and displaying intravascular data is provided. For example, during the course of a case, study, or procedure, a given patient may undergo multiple intravascular sensing measurements or recordings, such as intravascular ultrasound imaging or pressure-sensing, to evaluate a blockage in the patient’s blood vessel. Based on this data, a physician can make a clinical decision, such as whether and how to treat the patient and/or whether a treatment was successful. The present disclosure advantageously collects the data from the multiple intravascular sensing procedures and displays them in a manner to allow all of the data in an efficient manner. In that regard, a processor circuit of the computer system generates screen display that provides a list of all of the intravascular sensing measurements for the given patient, as well as a preview area next to the list. When the physician selects one of the measurements, important data for that measurement or recording is provided in the preview area. The important data can be data annotations that the physician has previously made, for example, such as a pressure ratio, or a length, diameter, and/or area measurement of the blood vessel. The preview area updates to display different, respective information when the physician selects another one of the measurements in the list. In this manner, the physician is able to review just the important information from multiple intravascular sensing measurements in an efficient manner. Prior to this system, the physician had to spend extra time individual reviewing each measurement alone, rather than being able to view the important data from each measurement on the same screen. With the system described herein, the physician is better able to synthesize the information from multiple measurements to more efficiently make clinical decisions, which benefits the health of the patient. The screen display can also provide important measurements in the list of measurements as well, such as the numerical value of a pressure ratio. For example, the physician can review intravascular images of the blood vessel in the preview area, while seeing the pressure ratios in the list of measurements. Advantageously, the physician is able to simultaneously consider measurements from different modalities (e.g., intravascular images and pressure sensing).

[0007] In some embodiments, the intravascular sensing system comprises a processor circuit configured to be in communication with a display and an intravascular catheter or guidewire, wherein the intravascular catheter or guidewire is configured to be positioned within a blood vessel of a patient and comprises a sensor configured to obtain intravascular data while positioned within the blood vessel, wherein the intravascular data comprises at least one of intravascular ultrasound (IVUS) imaging data or pressure data, and wherein the processor circuit is further configured to receive the intravascular data from a plurality of intravascular measurements for a patient, and to receive a user input corresponding to the selection of one of the plurality of intravascular measurements, and to generate a screen display comprising a list of the plurality of intravascular measurements for the patient, and a visual representation of the intravascular data associated with the selection of one of the plurality of intravascular measurements, wherein the visual representation of the intravascular data is provided adjacent to the list of the plurality of intravascular measurements, and output the screen display to the display.

[0008] In some embodiments, the processor circuit is configured to receive a user input corresponding to the selection of a different one of the plurality of intravascular measurements, wherein the processor circuit generating the screen display includes modifying the visual representation of the intravascular data to be associated with the selection of the different one of the plurality of intravascular measurements. In some embodiments, the one of the plurality of intravascular measurements and the different one of the plurality of intravascular measurement comprise different modalities. In some embodiments, the screen display comprises a single user interface element, wherein the list of the plurality of intravascular measurements is provided on a first portion of single user interface element, and wherein the visual representation of the intravascular data is provided on an adjacent second portion of the single user interface element. In some embodiments, the list of the plurality of intravascular measurements for the patient comprises a numerical value of a measurement associated with one or more of the plurality of intravascular measurements. In some embodiments, the measurement value comprises a pressure ratio corresponding to a pressure intravascular measurement. In some embodiments, the measurement value is provided proximate to a text label identifying a respective intravascular measurement in the list of the plurality of intravascular measurements.

[0009] In some embodiments, when the selection of one of the plurality of intravascular measurements is associated with an IVUS imaging measurement, the visual representation of the intravascular data comprises a tomographic image of the blood vessel, provided adjacent to the list of the plurality of intravascular measurements. In some embodiments, the visual

representation of the intravascular data comprises at least one of an area measurement or a length measurement associated with the blood vessel, provided adjacent to the list of the plurality of intravascular measurements. In some embodiments, the list of the plurality of intravascular measurements comprises a numerical value of a pressure ratio associated with a pressure intravascular measurement such that the numerical value of the pressure ratio is provided proximate to the tomographic image frame in the screen display. In some embodiments, the selection of one of the plurality of intravascular measurements is associated with a pressure intravascular measurement, the visual representation of the intravascular data comprises at least one of a trendline of a pressure ratio or a numerical value of the pressure ratio, provided adjacent to the list of the plurality of intravascular measurements. In some embodiments, the visual representation of the intravascular data comprises numerical value representative of a change in the pressure ratio in a selected portion of the trendline, provided adjacent to the list of the plurality of intravascular measurements.

[0010] In some embodiments, the list of the plurality of intravascular measurements comprises a hierarchical list including a first level element associated with each of the plurality of intravascular measurements and a second level element comprising the intravascular data associated with a respective intravascular measurement. In some embodiments, the respective intravascular measurement comprises an intravascular imaging measurement, the second level element comprises at least one of a bookmarked tomographic image frame or a saved tomographic image. In some embodiments, the processor circuit is configured to receive a user input corresponding to the selection of the least one of a bookmarked tomographic image frame or a saved tomographic image, wherein the processor circuit generating the screen display includes modifying the visual representation of the intravascular data to display the least one of a bookmarked tomographic image frame or a saved tomographic image, adjacent to the list of the plurality of intravascular measurements. In some embodiments, the respective intravascular measurement comprises a pressure intravascular measurement, the second level element comprises a bookmarked pressure ratio. In some embodiments, the processor circuit is configured to receive a user input corresponding to the selection of the bookmarked pressure ratio, wherein the processor circuit generating the screen display includes modifying the visual representation of the intravascular data to display the bookmarked pressure ratio, adjacent to the list of the plurality of intravascular measurements. [0011] Additional aspects, features, and advantages of the present disclosure will become apparent from the following detailed description.

BRIEF DESCRIPTION O RAWINGS

[0012] Illustrative embodiments of the present disclosure will be described with reference to the accompanying drawings, of which:

[0013] Figure 1 shows a diagrammatic perspective view of a vessel having a stenosis according to an embodiment of the present disclosure.

[0014] Figure 2 shows a diagrammatic, partial cross-sectional perspective view of a portion of the vessel of Figure 1 taken along section line 2-2 of Figure 1.

[0015] Figure 3 shows a diagrammatic, partial cross-sectional perspective view of the vessel of Figures 1 and 2 with instruments positioned therein according to an embodiment of the present disclosure.

[0016] Figure 4 shows a diagrammatic, schematic view of a system according to an embodiment of the present disclosure.

[0017] Figure 5 is a diagrammatic schematic view of an intraluminal imaging system, according to aspects of the present disclosure.

[0018] Figure 6 is an example procedure controller screen display with interactive case log and preview pane according to at least one embodiment of the present disclosure.

[0019] Figure 7 is an example procedure controller screen display with interactive case log and preview pane according to at least one embodiment of the present disclosure.

[0020] Figure 8 is an example procedure controller screen display with interactive case log and preview pane according to at least one embodiment of the present disclosure.

[0021] Figure 9 is a schematic diagram of a processor circuit, according to embodiments of the present disclosure.

[0022] Figure 10 is a flow diagram of a method implementing an example intravascular procedure case log system with dynamic preview, according to embodiments of the present disclosure.

[0023] Figure 11 is an example procedure controller screen display with interactive case log and preview pane according to at least one embodiment of the present disclosure.

[0024] Figure 12 is an example procedure controller screen display with interactive case log and preview pane according to at least one embodiment of the present disclosure.

[0025] Figure 13 is an example procedure controller screen display with interactive case log and preview pane according to at least one embodiment of the present disclosure. [0026] Figure 14 is an example procedure controller screen display with interactive case log and preview pane according to at least one embodiment of the present disclosure.

[0027] Figure 15 is an example procedure controller screen display with interactive case log and preview pane according to at least one embodiment of the present disclosure.

OFT ATT /FT) DESCRIPTION

[0028] Disclosed is an intravascular procedure case log system with dynamic preview. The case log system is structured to display patient information, along with a list of intravascular (IV) measurements performed on the patient during the procedure, with multiple modalities or data types including but not limited to iFR pullback, iFR spot measurements, FFR measurements, and IVUS pullback video. Other procedures, measurements, and modalities are contemplated depending on the implementation. The list of completed measurements is displayed in a parent/child format, relating parent data (e.g., a video loop or FFR measurement, or iFR measurement) to child data derived from the parent (e.g., bookmarks, saved frames or tomographic sections). The case log system provides the benefit of organizing patient-specific procedure data by measurement, regardless of its creation sequence. The case log system provides the further benefit of allowing a user (e.g., a cardiologist, vascular surgeon, or other clinician) to easily see whether archivable data elements (e.g., saved tomographic sections) have been created for each parent measurement, and if so how many have been created for each parent.

[0029] The case log system also includes a dynamic or interactive preview pane showing key information obtained during a selected measurement during a procedure, drawn from any parent or child item in the measurements list or case log. Such preview information may include but is not limited to video loops with interactive controls, bookmarked tomographic sections from a video that may be stepped through, iFR and FFR summary information, and iFR or FFR bookmarks that may be stepped through, each relating to a different measurement position or time (e.g., during a pullback sequence).

[0030] The video loops with interactive controls permit the user to play the’movie’ of a measurement (e.g., steps through the individual frames of an IVTJS pullback sequence), or jump between frames associated with bookmarks or saved tomographic sections. When a

measurement is opened, the interactive preview is configured to directly display the stored frame associated with that measurement bookmark or tomographic section. In some embodiments, the preview panel may also provide relevant information for each measurement element, including but not limited to date, time, catheter or guide wire type used, and pullback speed. In some embodiments, numerical values associated with the measurements may be shown in the preview images. In some embodiments, the case log system is configured to permit a user to tag a measurement with a note or clinically relevant location.

[0031] In an example, parent measurements are sorted or with the newest on top, as a physician might prefer while conducting a procedure, but can be sorted with the oldest (first acquired) on top as one might prefer when reviewing the chronological history of the procedure at a later time. In other embodiments, the procedure log may be sorted or filtered by modality (i.e., measurement type or data type).

[0032] To identify landmarks, a medical professional may select and mark imaging data to identify landmarks. In particular, the medical professional may select a single frame or tomographic section of a tomographic stack or series, inspect the frame, select a number of points on the frame (such as around a tissue border in the image) with an input device, and calculate the dimensions of the area within the points to determine a vessel or lumen area. The medical professional may then proceed to another frame and repeat the same process. Through analysis of these marked areas, the medical professional may be able to estimate the extent and severity of a lesion within the lumen.

[0033] The present disclosure aids substantially in the medical treatment of patients with, for example, cardiovascular conditions (e.g., the narrowing of a blood vessel), by improving the speed and efficacy of diagnosis, analysis, planning, and treatment. Implemented on a processor circuit in communication with a pressure-sensing guidewire and/or an intravascular imaging catheter, the case log system disclosed herein provides a case menu screen or procedure controller that provides practical access to multiple, critical clinical functions in one place in a streamlined workflow, including but not limited to diagnostic tool, measurement type, or modality selection, plus patient data entry and interactive data review, reduction, marking, annotation, archive, enhancement, and analysis. This streamlined workflow transforms a large volume of raw IV measurement data into a reduced selection of tomographic sections of particular interest, directly associated with relevant functional data at the same times or locations, without the normally routine need to change screens, change windows, change tabs, load different software, perform manual calculations, take notes, or otherwise interrupt the procedure or post-procedure analysis. This unconventional approach improves the functioning of the IV treatment hardware and software systems, by reducing the time required to analyze procedures by allowing the clinician to view essential or important data from each measurement, as we well as from measurements of different modalities, in ways that cannot practically be performed by the clinician without the case log system disclosed herein.

[0034] The intravascular procedure case log system with dynamic preview may be implemented as a procedure controller viewable on a display, and operated by an algorithm executing on a processor that accepts user inputs from a keyboard, mouse, or touchscreen interface, and that is in communication with one or more intravascular gui dewires and/or catheters incorporating functional sensors and/or imaging sensors. In that regard, the algorithm performs certain specific operations in response to different inputs or selections made at different locations on the procedure controller. The structures, functions, and operations of the processor, display, sensors, and user input systems advantageously enable novel features or aspects of the present disclosure with particularity. The present disclosure advantageously addresses a long- felt need for improved devices, systems, and methods for improving the quality of treatment and reducing workload on physicians by streamlining the storage, retrieval, display, reduction, augmentation, and analysis of IV image and functional data.

[0035] To promote understanding of the principles of the present disclosure, reference will now be made to the embodiments illustrated in the drawings, and specific language will be used to describe the same. It is nevertheless understood that no limitation to the scope of the disclosure is intended. Any alterations and further modifications to the described devices, systems, and methods, and any further application of the principles of the present disclosure are fully contemplated and included within the present disclosure as would normally occur to one skilled in the art to which the disclosure relates. In particular, it is fully contemplated that the features, components, and/or steps described with respect to one embodiment may be combined with the features, components, and/or steps described with respect to other embodiments of the present disclosure. For the sake of brevity, however, the numerous iterations of these combinations will not be described separately.

[0036] Figure 1 shows a diagrammatic perspective view of a vessel 100 having a stenosis 108 according to an embodiment of the present disclosure. The vessel 100 includes a proximal portion 102 and a distal portion 104. A lumen 106 extends along the length of the vessel 100 between the proximal portion 102 and the distal portion 104. In that regard, the lumen 106 is configured to allow the flow of fluid through the vessel. In some instances, the vessel 100 is a blood vessel. In some particular instances, the vessel 100 is a coronary artery. In such instances, the lumen 106 is configured to facilitate the flow of blood through the vessel 100.

[0037] As shown, the vessel 100 includes a stenosis 108 between the proximal portion 102 and the distal portion 104. Stenosis 108 is generally representative of any blockage or other structural arrangement that results in a restriction to the flow of fluid through the lumen 106 of the vessel 100. Embodiments of the present disclosure are suitable for use in a wide variety of vascular applications, including without limitation coronary, peripheral (including but not limited to lower limb, carotid, and neurovascular), renal, and/or venous. Where the vessel 100 is a blood vessel, the stenosis 108 may be a result of plaque buildup, including without limitation plaque components such as fibrous, fibro-lipidic (fibro fatty), necrotic core, calcified (dense calcium), blood, fresh thrombus, and mature thrombus. Generally, the composition of the stenosis will depend on the type of vessel being evaluated. In that regard, it is understood that the concepts of the present disclosure are applicable to virtually any type of blockage or other narrowing of a vessel that results in decreased fluid flow.

[0038] Figure 2 shows a diagrammatic, partial cross-sectional perspective view of a portion of the vessel of Figure 1 taken along section line 2-2 of Figure 1. The lumen 106 of the vessel 100 has a diameter 110 proximal of the stenosis 108 and a diameter 112 distal of the stenosis. In some instances, the diameters 110 and 112 are substantially equal to one another. In that regard, the diameters 110 and 112 are intended to represent healthy portions, or at least healthier portions, of the lumen 106 in comparison to stenosis 108. Accordingly, these healthier portions of the lumen 106 are illustrated as having a substantially constant cylindrical profile and, as a result, the height or width of the lumen has been referred to as a diameter. However, it is understood that in many instances these portions of the lumen 106 will also have plaque buildup, a non-symmetric profile, and/or other irregularities, but to a lesser extent than stenosis 108 and, therefore, will not have a cylindrical profile. In such instances, the diameters 110 and 112 are understood to be representative of a relative size or cross-sectional area of the lumen and do not imply a circular cross-sectional profile.

[0039] As shown in Fig. 2, stenosis 108 includes plaque buildup 114 that narrows the lumen 106 of the vessel 100. In some instances, the plaque buildup 114 does not have a uniform or symmetrical profile, making angiographic evaluation of such a stenosis unreliable. In the illustrated embodiment, the plaque buildup 114 includes an upper portion 116 and an opposing lower portion 118. In that regard, the lower portion 118 has an increased thickness relative to the upper portion 116 that results in a non-symmetrical and non-uniform profile relative to the portions of the lumen proximal and distal of the stenosis 108. As shown, the plaque buildup 114 decreases the available space for fluid to flow through the lumen 106. In particular, the cross- sectional area of the lumen 106 is decreased by the plaque buildup 114. At the narrowest point between the upper and lower portions 116, 118 the lumen 106 has a height 120, which is representative of a reduced size or cross-sectional area relative to the diameters 110 and 112 proximal and distal of the stenosis 108. Note that the stenosis 108, including plaque buildup 114 is exemplary in nature and should not be considered limiting in any way. In that regard, it is understood that the stenosis 108 has other shapes and/or compositions that limit the flow of fluid through the lumen 106 in other instances. While the vessel 100 is illustrated in Figs. 1 and 2 as having a single stenosis 108 and the description of the embodiments below is primarily made in the context of a single stenosis, it is nevertheless understood that the devices, systems, and methods described herein have similar application for a vessel having multiple stenosis regions.

[0040] Figure 3 shows a diagrammatic, partial cross-sectional perspective view of the vessel of Figures 1 and 2 with instruments 130 and 132 positioned therein according to at least one embodiment of the present disclosure. In general, instruments 130 and 132 may be any form of device, instrument, or probe sized and shaped to be positioned within a vessel. In the illustrated embodiment, instrument 130 is generally representative of a guide wire, while instrument 132 is generally representative of a catheter. In that regard, instrument 130 extends through a central lumen of instrument 132. However, in other embodiments, the instruments 130 and 132 take other forms. In that regard, the instruments 130 and 132 are of similar form in some

embodiments. For example, in some instances, both instruments 130 and 132 are guide wires.

In other instances, both instruments 130 and 132 are catheters. On the other hand, the instruments 130 and 132 are of different form in some embodiments, such as the illustrated embodiment, where one of the instruments is a catheter and the other is a guide wire. Further, in some instances, the instruments 130 and 132 are disposed coaxial with one another, as shown in the illustrated embodiment of Fig. 3. In other instances, one of the instruments extends through an off-center lumen of the other instrument. In yet other instances, the instruments 130 and 132 extend side-by-side. In some particular embodiments, at least one of the instruments is as a rapid-exchange device, such as a rapid-exchange catheter. In such embodiments, the other instrument is a buddy wire or other device configured to facilitate the introduction and removal of the rapid-exchange device. Further still, in other instances, instead of two separate instruments 130 and 132 a single instrument is utilized. In some embodiments, the single instrument incorporates aspects of the functionalities (e.g., data acquisition) of both instruments 130 and 132.

[0041] Instrument 130 is configured to obtain diagnostic information about the vessel 100.

In that regard, the instrument 130 includes one or more sensors, transducers, and/or other monitoring elements configured to obtain the diagnostic information about the vessel. The diagnostic information includes one or more of pressure, flow (velocity and/or volume), images (including images obtained using ultrasound (e.g., IVUS), OCT, thermal, and/or other imaging techniques), temperature, and/or combinations thereof. The one or more sensors, transducers, and/or other monitoring elements are positioned adjacent a distal portion of the instrument 130 in some instances. In that regard, the one or more sensors, transducers, and/or other monitoring elements are positioned less than 30 cm, less than 10 cm, less than 5 cm, less than 3 cm, less than 2 cm, and/or less than 1 cm from a distal tip 134 of the instrument 130 in some instances. In some instances, at least one of the one or more sensors, transducers, and/or other monitoring elements is positioned at the distal tip of the instrument 130.

[0042] In an example, the instrument 130 includes at least one element configured to monitor pressure within the vessel 100. The pressure monitoring element can take the form a piezo- resistive pressure sensor, a piezo-electric pressure sensor, a capacitive pressure sensor, an electromagnetic pressure sensor, a fluid column (the fluid column being in communication with a fluid column sensor that is separate from the instrument and/or positioned at a portion of the instrument proximal of the fluid column), an optical pressure sensor, and/or combinations thereof. In some instances, one or more features of the pressure monitoring element are implemented as a solid-state component manufactured using semiconductor and/or other suitable manufacturing techniques. Examples of commercially available guide wire products that include suitable pressure monitoring elements include, without limitation, the PrimeWire PRESTIGE® pressure guide wire, the PrimeWire® pressure guide wire, and the ComboWire® XT pressure and flow guide wire, each available from Philips, as well as the PressureWire™ Certus guide wire and the PressureWire™ Aeris guide wire, each available from St. Jude Medical, Inc.

Generally, the instrument 130 is sized such that it can be positioned through the stenosis 108 without significantly impacting fluid flow across the stenosis, which would impact the distal pressure reading. Accordingly, in some instances the instrument 130 has an outer diameter of 0.018” or less. In some embodiments, the instrument 130 has an outer diameter of 0.014” or less.

[0043] Instrument 132 is also configured to obtain diagnostic information about the vessel 100. In some instances, instrument 132 is configured to obtain the same diagnostic information as instrument 130. In other instances, instrument 132 is configured to obtain different diagnostic information than instrument 130, which may include additional diagnostic information, less diagnostic information, and/or alternative diagnostic information. The diagnostic information obtained by instrument 132 includes one or more of pressure, flow (velocity and/or volume), images (including images obtained using ultrasound (e.g., IVUS), OCT, thermal, and/or other imaging techniques), temperature, and/or combinations thereof. Instrument 132 includes one or more sensors, transducers, and/or other monitoring elements configured to obtain this diagnostic information. In that regard, the one or more sensors, transducers, and/or other monitoring elements are positioned adjacent a distal portion of the instrument 132 in some instances. In that regard, the one or more sensors, transducers, and/or other monitoring elements are positioned less than 30 cm, less than 10 cm, less than 5 cm, less than 3 cm, less than 2 cm, and/or less than 1 cm from a distal tip 136 of the instrument 132 in some instances. In some instances, at least one of the one or more sensors, transducers, and/or other monitoring elements is positioned at the distal tip of the instrument 132.

[0044] Similar to instrument 130, instrument 132 also includes at least one element configured to monitor pressure within the vessel 100. The pressure monitoring element can take the form a piezo-resistive pressure sensor, a piezo-electric pressure sensor, a capacitive pressure sensor, an electromagnetic pressure sensor, a fluid column (the fluid column being in

communication with a fluid column sensor that is separate from the instrument and/or positioned at a portion of the instrument proximal of the fluid column), an optical pressure sensor, and/or combinations thereof. In some instances, one or more features of the pressure monitoring element are implemented as a solid-state component manufactured using semiconductor and/or other suitable manufacturing techniques. Currently available catheter products suitable for use with one or more of Siemens AXIOM Sensis, Mennen Horizon XVu, and Philips Xper IM Physiomonitoring 5 and include pressure monitoring elements can be utilized for instrument 132 in some instances.

[0045] In accordance with aspects of the present disclosure, at least one of the instruments 130 and 132 is configured to monitor a pressure within the vessel 100 distal of the stenosis 108 and at least one of the instruments 130 and 132 is configured to monitor a pressure within the vessel proximal of the stenosis. In that regard, the instruments 130, 132 are sized and shaped to allow positioning of the at least one element configured to monitor pressure within the vessel 100 to be positioned proximal and/or distal of the stenosis 108 as necessary based on the configuration of the devices. In that regard, Fig. 3 illustrates a position 138 suitable for measuring pressure distal of the stenosis 108. In that regard, the position 138 is less than 5 cm, less than 3 cm, less than 2 cm, less than 1 cm, less than 5 mm, and/or less than 2.5 mm from the distal end of the stenosis 108 (as shown in Fig. 2) in some instances. Fig. 3 also illustrates a plurality of suitable positions for measuring pressure proximal of the stenosis 108. In that regard, positions 140, 142, 144, 146, and 148 each represent a position that is suitable for monitoring the pressure proximal of the stenosis in some instances. In that regard, the positions 140, 142, 144, 146, and 148 are positioned at varying distances from the proximal end of the stenosis 108 ranging from more than 20 cm down to about 5 mm or less. Generally, the proximal pressure measurement will be spaced from the proximal end of the stenosis.

Accordingly, in some instances, the proximal pressure measurement is taken at a distance equal to or greater than an inner diameter of the lumen of the vessel from the proximal end of the stenosis. In the context of coronary artery pressure measurements, the proximal pressure measurement is generally taken at a position proximal of the stenosis and distal of the aorta, within a proximal portion of the vessel. However, in some particular instances of coronary artery pressure measurements, the proximal pressure measurement is taken from a location inside the aorta. In other instances, the proximal pressure measurement is taken at the root or ostium of the coronary artery.

[0046] In some embodiments, at least one of the instruments 130 and 132 is configured to monitor pressure within the vessel 100 while being moved through the lumen 106. In some instances, instrument 130 is configured to be moved through the lumen 106 and across the stenosis 108. In that regard, the instrument 130 is positioned distal of the stenosis 108 and moved proximally (i.e., pulled back) across the stenosis to a position proximal of the stenosis in some instances. In other instances, the instrument 130 is positioned proximal of the stenosis 108 and moved distally across the stenosis to a position distal of the stenosis. Movement of the instrument 130, either proximally or distally, is controlled manually by medical personnel (e.g., hand of a surgeon) in some embodiments. In other embodiments, movement of the instrument 130, either proximally or distally, is controlled automatically by a movement control device (e.g., a pullback device, such as the R-100 pullback device available from Philips). In that regard, the movement control device controls the movement of the instrument 130 at a selectable and known speed (e.g., 2.0 mm/s, 1.0 mm/s, 0.5 mm/s, 0.2 mm/s, etc.) in some instances. Movement of the instrument 130 through the vessel is continuous for each pullback or push through, in some instances. In other instances, the instrument 130 is moved step-wise through the vessel (i.e., repeatedly moved a fixed amount of distance and/or a fixed amount of time). Some aspects of the visual depictions discussed below are particularly suited for embodiments where at least one of the instruments 130 and 132 is moved through the lumen 106. Further, in some particular instances, aspects of the visual depictions discussed below are particularly suited for

embodiments where a single instrument is moved through the lumen 106, with or without the presence of a second instrument.

[0047] In some instances, use of a single instrument has a benefit in that it avoids issues associated with variations in pressure measurements of one instrument relative to another over time, which is commonly referred to as drift. In that regard, a major source of drift in traditional Fractional Flow Reserve (FFR) measurements is divergence in the pressure reading of a guide wire relative to the pressure reading of a guide catheter. In that regard, because FFR is calculated as the ratio of the pressure measurement obtained by the guide wire to the pressure measurement obtained by the catheter, this divergence has an impact on the resulting FFR value. In contrast, where a single instrument is utilized to obtain pressure measurements as it is moved through the vessel, drift is negligible or non-existent. For example, in some instances, the single instrument is utilized to obtain relative changes in pressures as it is moved through the vessel such that the time period between pressure measurements is short enough to prevent any impact from any changes in pressure sensitivity of the instrument (e.g., less than 500 ms, less than 100 ms, less than 50 ms, less than 10 ms, less than 5 ms, less than 1 ms, or otherwise).

[0048] Figure 4 shows a diagrammatic, schematic view of a system 150 according to an embodiment of the present disclosure. As shown, the system 150 includes an instrument 152. In that regard, in some instances instrument 152 is suitable for use as at least one of instruments 130 and 132 discussed above. Accordingly, in some instances the instrument 152 includes features similar to those discussed above with respect to instruments 130 and 132. In the illustrated embodiment, the instrument 152 is a guide wire having a distal portion 154 and a housing 156 positioned adjacent the distal portion. In that regard, the housing 156 is spaced approximately 3 cm from a distal tip of the instrument 152. The housing 156 is configured to house one or more sensors, transducers, and/or other monitoring elements configured to obtain the diagnostic information about the vessel. In the illustrated embodiment, the housing 156 contains at least a pressure sensor configured to monitor a pressure within a lumen in which the instrument 152 is positioned. A shaft 158 extends proximally from the housing 156. A torque device 160 is positioned over and coupled to a proximal portion of the shaft 158. A proximal end portion 162 of the instrument 152 is coupled to a connector 164. A cable 166 extends from connector 164 to a connector 168. In some instances, connector 168 is configured to be plugged into an interface 170. In that regard, interface 170 is a patient interface module (PIM) in some instances. In some instances, the cable 166 is replaced with a wireless connection. In that regard, it is understood that various communication pathways between the instrument 152 and the interface 170 may be utilized, including physical connections (including electrical, optical, and/or fluid connections), wireless connections, and/or combinations thereof.

[0049] The interface 170 is communicatively coupled to a computing device 172 via a connection 174. Computing device 172 is generally representative of any device suitable for performing the processing and analysis techniques discussed within the present disclosure. In some embodiments, the computing device 172 includes a processor, random access memory, and a storage medium. In that regard, in some particular instances the computing device 172 is programmed to execute steps associated with the data acquisition and analysis described herein. Accordingly, it is understood that any steps related to data acquisition, data processing, instrument control, and/or other processing or control aspects of the present disclosure may be implemented by the computing device using corresponding instructions stored on or in a non- transitory computer readable medium accessible by the computing device. In some instances, the computing device 172 is a console device. In some particular instances, the computing device 172 is similar to the s5™ Imaging System or the s5i™ Imaging System, each available from Philips. In some instances, the computing device 172 is portable (e.g., handheld, on a rolling cart, etc.). Further, it is understood that in some instances the computing device 172 comprises a plurality of computing devices. In that regard, it is particularly understood that the different processing and/or control aspects of the present disclosure may be implemented separately or within predefined groupings using a plurality of computing devices. Any divisions and/or combinations of the processing and/or control aspects described below across multiple computing devices are within the scope of the present disclosure.

[0050] Together, connector 164, cable 166, connector 168, interface 170, and connection 174 facilitate communication between the one or more sensors, transducers, and/or other monitoring elements of the instrument 152 and the computing device 172. However, this communication pathway is exemplary in nature and should not be considered limiting in any way. In that regard, it is understood that any communication pathway between the instrument 152 and the computing device 172 may be utilized, including physical connections (including electrical, optical, and/or fluid connections), wireless connections, and/or combinations thereof. In that regard, it is understood that the connection 174 is wireless in some instances. In some instances, the connection 174 includes a communication link over a network (e.g., intranet, internet, telecommunications network, and/or other network). In that regard, it is understood that the computing device 172 is positioned remote from an operating area where the instrument 152 is being used in some instances. Having the connection 174 include a connection over a network can facilitate communication between the instrument 152 and the remote computing device 172 regardless of whether the computing device is in an adjacent room, an adjacent building, or in a different state/country. Further, it is understood that the communication pathway between the instrument 152 and the computing device 172 is a secure connection in some instances. Further still, it is understood that, in some instances, the data communicated over one or more portions of the communication pathway between the instrument 152 and the computing device 172 is encrypted.

[0051] The system 150 also includes an instrument 175. In that regard, in some instances instrument 175 is suitable for use as at least one of instruments 130 and 132 discussed above. Accordingly, in some instances the instrument 175 includes features similar to those discussed above with respect to instruments 130 and 132. In the illustrated embodiment, the instrument 175 is a catheter- type device. In that regard, the instrument 175 includes one or more sensors, transducers, and/or other monitoring elements adjacent a distal portion of the instrument configured to obtain the diagnostic information about the vessel. In the illustrated embodiment, the instrument 175 includes a pressure sensor configured to monitor a pressure within a lumen in which the instrument 175 is positioned. The instrument 175 is in communication with an interface 176 via connection 177. In some instances, interface 176 is a hemodynamic monitoring system or other control device, such as Siemens AXIOM Sensis, Mennen Horizon XVu, and Philips Xper IM Physiomonitoring 5. In one particular embodiment, instrument 175 is a pressure-sensing catheter that includes fluid column extending along its length. In such an embodiment, interface 176 includes a hemostasis valve fluidly coupled to the fluid column of the catheter, a manifold fluidly coupled to the hemostasis valve, and tubing extending between the components as necessary to fluidly couple the components. In that regard, the fluid column of the catheter is in fluid communication with a pressure sensor via the valve, manifold, and tubing. In some instances, the pressure sensor is part of interface 176. In other instances, the pressure sensor is a separate component positioned between the instrument 175 and the interface 176.

The interface 176 is communicatively coupled to the computing device 172 via a connection 178.

[0052] Similar to the connections between instrument 152 and the computing device 172, interface 176 and connections 177 and 178 facilitate communication between the one or more sensors, transducers, and/or other monitoring elements of the instrument 175 and the computing device 172. However, this communication pathway is exemplary in nature and should not be considered limiting in any way. In that regard, it is understood that any communication pathway between the instrument 175 and the computing device 172 may be utilized, including physical connections (including electrical, optical, and/or fluid connections), wireless connections, and/or combinations thereof. In that regard, it is understood that the connection 178 is wireless in some instances. In some instances, the connection 178 includes a communication link over a network (e.g., intranet, internet, telecommunications network, and/or other network). In that regard, it is understood that the computing device 172 is positioned remote from an operating area where the instrument 175 is being used in some instances. Having the connection 178 include a connection over a network can facilitate communication between the instrument 175 and the remote computing device 172 regardless of whether the computing device is in an adjacent room, an adjacent building, or in a different state/country. Further, it is understood that the

communication pathway between the instrument 175 and the computing device 172 is a secure connection in some instances. Further still, it is understood that, in some instances, the data communicated over one or more portions of the communication pathway between the instrument 175 and the computing device 172 is encrypted.

[0053] It is understood that one or more components of the system 150 are not included, are implemented in a different arrangement/order, and/or are replaced with an alternative device/mechanism in other embodiments of the present disclosure. For example, in some instances, the system 150 does not include interface 170 and/or interface 176. In such instances, the connector 168 (or other similar connector in communication with instrument 152 or instrument 175) may plug into a port associated with computing device 172. Alternatively, the instruments 152, 175 may communicate wirelessly with the computing device 172. Generally speaking, the communication pathway between either or both of the instruments 152, 175 and the computing device 172 may have no intermediate nodes (i.e., a direct connection), one intermediate node between the instrument and the computing device, or a plurality of intermediate nodes between the instrument and the computing device.

[0054] Figure 5 is a diagrammatic schematic view of an intraluminal imaging system 550, according to aspects of the present disclosure. The intraluminal imaging system 550 can be an intravascular ultrasound (IVUS) imaging system in some embodiments. The intraluminal imaging system 550 may include an intraluminal device 502, a patient interface module (PIM) 570, a console or processing system 572, and a monitor 578. The intraluminal device 502 is sized and shaped, and/or otherwise structurally arranged to be positioned within a body lumen of a patient. For example, the intraluminal device 502 can be a catheter, guide wire, guide catheter, pressure wire, and/or flow wire in various embodiments. In some circumstances, the system 550 may include additional elements and/or may be implemented without one or more of the elements illustrated in Figure 5. In some embodiments, the intraluminal imaging system 550 is configured to automatically identify and measure landmarks within a lumen, such as tissue borders, areas of interest, and lesions. These measurements may assist a user in visualizing the lumen, as well as recommending further imaging or treatment measurements.

[0055] The intraluminal imaging system 550 (or intravascular imaging system) can be any type of imaging system suitable for use in the lumens or vasculature of a patient. In some embodiments, the intraluminal imaging system 550 is an intraluminal ultrasound (IVUS) imaging system. In other embodiments, the intraluminal imaging system 550 may include systems configured for forward looking intraluminal ultrasound (FL-IVUS) imaging, intraluminal photoacoustic (IVPA) imaging, intracardiac echocardiography (ICE),

transesophageal echocardiography (TEE), and/or other suitable imaging modalities.

[0056] It is understood that the system 550 and/or device 502 can be configured to obtain any suitable intraluminal imaging data. In some embodiments, the device 502 can include an imaging component of any suitable imaging modality, such as optical imaging, optical coherence tomography (OCT), etc. In some embodiments, the device 502 can include any suitable imaging component, including a pressure sensor, a flow sensor, a temperature sensor, an optical fiber, a reflector, a mirror, a prism, an ablation element, a radio frequency (RF) electrode, a conductor, and/or combinations thereof. Generally, the device 502 can include an imaging element to obtain intraluminal data associated with the lumen 506. The device 502 may be sized and shaped (and/or configured) for insertion into a vessel or lumen 506 of the patient.

[0057] The system 550 may be deployed in a catheterization laboratory having a control room. The processing system 572 may be located in the control room. Optionally, the processing system 572 may be located elsewhere, such as in the catheterization laboratory itself. The catheterization laboratory may include a sterile field while its associated control room may or may not be sterile depending on the procedure to be performed and/or on the health care facility. The catheterization laboratory and control room may be used to perform any number of medical imaging measurements such as angiography, fluoroscopy, CT, IVUS, virtual histology (VH), forward looking IVUS (FL-IVUS), intraluminal photoacoustic (IVPA) imaging, a fractional flow reserve (FFR) determination, a coronary flow reserve (CFR) determination, optical coherence tomography (OCT), computed tomography, intracardiac echocardiography (ICE), forward-looking ICE (FLICE), intraluminal palpography, transesophageal ultrasound, fluoroscopy, angiography, and other medical imaging modalities whether presently known or hereinafter developed, or combinations thereof. In some embodiments, device 502 may be controlled from a remote location such as the control room, such than an operator is not required to be in close proximity to the patient.

[0058] The intraluminal device 502, PIM 570, and monitor 578 may be communicatively coupled directly or indirectly to the processing system 572. These elements may be

communicatively coupled to the medical processing system 572 via a wired connection such as a standard copper link or a fiber optic link and/or via wireless connections using IEEE 802.11 Wi- Fi standards, Ultra Wide-Band (UWB) standards, wireless FireWire, wireless USB, or another high-speed wireless networking standard. The processing system 572 may be communicatively coupled to one or more data networks, e.g., a TCP/IP-based local area network (LAN). In other embodiments, different protocols may be utilized such as Synchronous Optical Networking (SONET). In some cases, the processing system 572 may be communicatively coupled to a wide area network (WAN). The processing system 572 may utilize network connectivity to access various resources. For example, the processing system 572 may communicate with a Digital Imaging and Communications in Medicine (DICOM) system, a Picture Archiving and

Communication System (PACS), and/or a Hospital Information System via a network connection.

[0059] At a high level, the intraluminal device 502 emits ultrasonic energy from a transducer array 124 included in scanner assembly 510 mounted near a distal end of the intraluminal device 502. The ultrasonic energy is reflected by tissue structures in the medium (such as a lumen 506) surrounding the scanner assembly 510, and the ultrasound echo signals are received by the transducer array 124. The scanner assembly 510 generates electrical signal(s) representative of the ultrasound echoes. The scanner assembly 510 can include one or more single ultrasound transducers and/or a transducer array 124 in any suitable configuration, such as a planar array, a curved array, a circumferential array, an annular array, etc. For example, the scanner assembly 510 can be a one-dimensional array or a two-dimensional array in some instances. In some instances, the scanner assembly 510 can be a rotational ultrasound device. The active area of the scanner assembly 510 can include one or more transducer materials and/or one or more segments of ultrasound elements (e.g., one or more rows, one or more columns, and/or one or more orientations) that can be uniformly or independently controlled and activated. The active area of the scanner assembly 510 can be patterned or structured in various basic or complex geometries. The scanner assembly 510 can be disposed in a side-looking orientation (e.g., ultrasonic energy emitted perpendicular and/or orthogonal to the longitudinal axis of the intraluminal device 502) and/or a forward-looking looking orientation (e.g., ultrasonic energy emitted parallel to and/or along the longitudinal axis). In some instances, the scanner assembly 510 is structurally arranged to emit and/or receive ultrasonic energy at an oblique angle relative to the longitudinal axis, in a proximal or distal direction. In some embodiments, ultrasonic energy emission can be electronically steered by selective triggering of one or more transducer elements of the scanner assembly 510.

[0060] The ultrasound transducer(s) of the scanner assembly 510 can be a piezoelectric micromachined ultrasound transducer (PMUT), capacitive micromachined ultrasonic transducer (CMUT), single crystal, lead zirconate titanate (PZT), PZT composite, other suitable transducer type, and/or combinations thereof. In an embodiment the ultrasound transducer array 524 can include any suitable number of individual transducer elements. For example, the array 524 can include between 1 acoustic element and 1000 acoustic elements, including values such as 2 acoustic elements, 4 acoustic elements, 36 acoustic elements, 64 acoustic elements, 128 acoustic elements, 500 acoustic elements, 812 acoustic elements, and/or other values both larger and smaller.

[0061] The PIM 570 transfers the received echo signals to the processing system 572 where the ultrasound image (including the flow information) is reconstructed and displayed on the monitor 578. The console or processing system 572 can include a processor and a memory. The processing system 572 may be operable to facilitate the features of the intraluminal imaging system 550 described herein. For example, the processor can execute computer readable instructions stored on the non-transitory tangible computer readable medium.

[0062] The PIM 570 facilitates communication of signals between the processing system 572 and the scanner assembly 510 included in the intraluminal device 502. This communication may include providing commands to integrated circuit controller chip(s) within the intraluminal device 502, select particular element(s) on the transducer array 524 to be used for transmit and receive, providing the transmit trigger signals to the integrated circuit controller chip(s) to activate the transmitter circuitry to generate an electrical pulse to excite the selected transducer array element(s), and/or accepting amplified echo signals received from the selected transducer array element(s) via amplifiers included on the integrated circuit controller chip(s). In some embodiments, the PIM 570 performs preliminary processing of the echo data prior to relaying the data to the processing system 572. In examples of such embodiments, the PIM 570 performs amplification, filtering, and/or aggregating of the data. In an embodiment, the PIM 570 also supplies high- and low-voltage DC power to support operation of the intraluminal device 502 including circuitry within the scanner assembly 510. [0063] In some embodiments, the IVUS data and/or the external ultrasound data may be co registered with the 2D or 3D CT image, which may further improve placement accuracy and decrease procedural time. The placement of the intraluminal device 502 may be verified with this multi-imaging system, which may improve outcomes versus standard fluoroscopic guidance. In some embodiments, the intraluminal device 502 is tracked to the target location as identified on a CT image and/or angiogram (such as a lesion or aneurysm). In some embodiments, a roadmap produced from co-registered IVTJS and CT image data may be correlated to fluoroscopic data to further improve accuracy. For example, the processing system 572 may create an imaging loop based on the roadmap and fluoroscopic data to improve the navigation of the intraluminal device 502 through the vessels of the patient.

[0064] The processing system 572 receives echo data from the scanner assembly 510 by way of the PIM 570 and processes the data to reconstruct an image of the tissue structures in the medium surrounding the scanner assembly 510. Generally, the device 502 can be utilized within any suitable anatomy and/or body lumen of the patient. The processing system 572 outputs image data such that an image of the vessel or lumen 506, such as a cross-sectional IVUS image of the lumen 506, is displayed on the monitor 578. Lumen 506 may represent fluid filled or surrounded structures, both natural and man-made. Lumen 506 may be within a body of a patient. Lumen 506 may be a blood vessel, as an artery or a vein of a patient’s vascular system, including cardiac vasculature, peripheral vasculature, neural vasculature, renal vasculature, and/or or any other suitable lumen inside the body. For example, the device 502 may be used to examine any number of anatomical locations and tissue types, including without limitation, organs including the liver, heart, kidneys, gall bladder, pancreas, lungs; ducts; intestines; nervous system structures including the brain, dural sac, spinal cord and peripheral nerves; the urinary tract; as well as valves within the blood, chambers or other parts of the heart, and/or other systems of the body. In addition to natural structures, the device 502 may be used to examine man-made structures such as, but without limitation, heart valves, stents, shunts, filters and other devices.

[0065] The controller or processing system 572 may include a processing circuit having one or more processors in communication with memory and/or other suitable tangible computer readable storage media. The controller or processing system 572 may be configured to carry out one or more aspects of the present disclosure. In some embodiments, the processing system 572 and the monitor 578 are separate components. In other embodiments, the processing system 572 and the monitor 578 are integrated in a single component. For example, the system 550 can include a touch screen device, including a housing having a touch screen display and a processor. The system 550 can include any suitable input device, such as a touch sensitive pad or touch screen display, keyboard/mouse, joystick, button, etc., for a user to select options shown on the monitor 578. The processing system 572, the monitor 578, the input device, and/or combinations thereof can be referenced as a controller of the system 550. The controller can be in

communication with the device 502, the PIM 570, the processing system 572, the monitor 578, the input device, and/or other components of the system 550.

[0066] In some embodiments, the processing system 572 may be configured to automatically measure landmarks or key luminal areas within a lumen. These landmarks may include borders of tissue layers (such as a lumen or vessel border). The dimensions of these landmarks may be automatically measured by the processing system 572. These measurements may be displayed on one or more images of the lumen. In some embodiments, the measurements may be used to identify lesions within the lumen and determine the severity and extent of these lesions. The identification and measurement these landmarks may a user to easily visualize a lumen within the patient and accurately assess the severity and extent of lesions therein. This may add confidence to the assessment of lesions and save time in measurement procedures.

[0067] In some embodiments, the intraluminal device 502 includes some features similar to traditional solid-state IVUS catheters, such as the EagleEye® catheter available from Philips and those disclosed in U.S. Patent No. 7,846,101 hereby incorporated by reference in its entirety.

For example, the intraluminal device 502 may include the scanner assembly 510 near a distal end of the intraluminal device 502 and a transmission line bundle 512 extending along the longitudinal body of the intraluminal device 502. The cable or transmission line bundle 512 can include a plurality of conductors, including one, two, three, four, five, six, seven, or more conductors.

[0068] The transmission line bundle 512 terminates in a PIM connector 114 at a proximal end of the intraluminal device 502. The PIM connector 114 electrically couples the transmission line bundle 512 to the PIM 570 and physically couples the intraluminal device 502 to the PIM 570. In an embodiment, the intraluminal device 502 further includes a gui dewire exit port 516. Accordingly, in some instances the intraluminal device 502 is a rapid-exchange catheter. The guidewire exit port 516 allows a gui dewire 518 to be inserted towards the distal end in order to direct the intraluminal device 502 through the lumen 506.

[0069] The monitor 578 may be a display device such as a computer monitor or other type of screen. The monitor 578 may be used to display selectable prompts, instructions, and visualizations of imaging data to a user. In some embodiments, the monitor 578 may be used to provide a procedure-specific workflow to a user to complete an intraluminal imaging procedure. This workflow may include performing a pre-stent plan to determine the state of a lumen and potential for a stent, as well as checking on a stent that has been positioned in a lumen. The workflow may be presented to a user as any of the displays or visualizations shown in Figs. 6-8.

[0070] Figure 6 is an example patient-specific procedure controller 600 with interactive procedure history 630 and interactive preview pane 650 according to at least one embodiment of the present disclosure. The procedure controller 600 is a screen display that may be displayed, for example, on monitor 578 and operated by processing system 572 (see Fig 5) or computing device 172 (see Fig 4). The screen display can be generated based on medical data (e.g., ultrasound imaging data, pressure measurement data, flow measurement data, etc.) accessible by a processor circuit. For example, the processor circuit can be implemented in a system that obtained the intravascular data or a system that is in communication with memory from which the intravascular data can be retrieved (whether or not the system was used to obtain the intravascular data). The processor circuit can be in communication with one or more

intraluminal devices (e.g., guidewire, catheter, and/or guide catheter) including a flexible elongate member having a proximal portion positioned outside of the patient and a distal portion configured to be positioned inside of a body lumen of the patient during a diagnostic and/or therapeutic procedure. One or more sensors configured to obtain medical data (e.g., an imaging transducer, a pressure sensor, a flow sensor, etc.) associated with anatomy can be coupled to the distal portion of the flexible elongate member. For example, the instrument 130, instrument 132, instrument 152, instrument 175, and/or instrument 502 can be an intraluminal catheter or guidewire, such as an intravascular or intracardiac catheter or guidewire.

[0071] The case log system is structured to display patient information 602 such as name and Patient ID number, along with a history or case log 630 of intravascular (IV) measurements performed on the patient, including but not limited to iFR pullback, iFR spot measurements, FFR measurements, and IVTJS pullback video. Other measurements and modalities are contemplated including functional measurements, image snapshots, and video sequences from a variety of different sensor types, whether presently known or hereinafter developed. Generally, the case log or procedure history 630 can include previous physiological and/or functional measurements (e.g., pressure and/or flow) and/or imaging measurements (e.g., IVUS, ICE, TEE, external ultrasound, x-ray, CT, MRI, etc.) performed on the particular patient associated with information 602. The case log system also includes a dynamic or interactive preview pane 650 showing key information obtained during a selected measurement within the procedure. Such preview information may include but is not limited to image snapshots, video loops with interactive controls, and functional measurements.

[0072] The patient-specific case log procedure controller 600 also includes a measurement type selector or modality selector 620 that permits an operator (e.g., a cardiologist, vascular surgeon, or other clinician) to initiate a new measurement within the current procedure, on the patient associated with the patient information 602. Once the new measurement is performed, that measurement will be added to the list in the history 630. In the example shown, the available modalities or measurement types are an iFR/FFR type 622 and an IVUS type 624.

Other modalities or measurement types are also contemplated. The case log procedure controller 600 also includes an exit button 604 to end the procedure and a functional menu activator 606.

[0073] In the embodiment shown in the figure, the interactive procedure history 630 is configured in a parent/child structure. For example, the parents 635 represent individual measurements that have been performed during the procedure, including but not limited to FFR measurement, iFR pullback, iFR spot measurement, and IVUS video (e.g., from an IVUS pullback sequence). Depending on the implementation, each parent 635 may include summary information such as time, date, final measurement result, or otherwise. Each parent may be displayed in a collapsed mode where its children 637 are not visible, or may be displayed in an expanded mode where its children are visible. Children 637 of a IVUS video loop may include saved frames and bookmarked frames. Children 637 of a pressure sensing measurement can include iFR or FFR data associated with a particular time or location within the vessel. Children of IVUS, iFR, and/or FFR measurements may include summary information and bookmarks that may be stepped through, each relating to a different measurement position or time (e.g., during a pullback sequence). In some embodiments, the hierarchical structure of the history 630 can be referenced as including top level or first level (e.g., the parent 635) intravascular sensing measurement and a lower level or second level (e.g., child 637) image frame, measurement, and/or other data points of the top level intravascular sensing measurement.

[0074] The preview 650 can be updated in response to user selection of a given parent 635 and/or child 637. For example, upon selection of the parent 635 (e.g., IVUS videoloop in Fig. 6), a representative IVUS image frame within the video can be displayed in the pane 660). In various embodiments, the image pane 660 that is first shown upon selection of the parent 635 is the first image frame of the loop, the last image frame, one of the saved frames, and/or one of the bookmarked frames. For example, upon selection of one of the children 637 (e.g., one of the saved frames or the bookmark), the specific IVUS frame corresponding to that child is displayed in the pane 660. The formatting of text associated with the selected mode parent 635 can be different than the formatting of text associated with the unselected mode parent 635 (e.g., coloring, bolding, typeface, etc.) In some embodiments, the parent 635 can be expanded to display the children 637 independently of whether the parent 635 is selected (e.g., the

corresponding data is shown in the preview 650). For example, multiple parents 635 can be simultaneously in an expanded mode in the history 630. In the illustrated embodiment, one of the parents 635 is selected and the corresponding data is shown in preview 650. In other embodiments, two or more of the parents 635 can be selected, expanded, and shown in the procedure history 630. When none of the parents 635 are selected, the preview 650 can be absent in the controller 600 so that the history 630 expands into the space occupied by the preview 650 or the preview 650 is blank. In some embodiments, the preview pane 650 may be a pop-up or pop-over that appears over the main display (e.g., the history 630). For example, a pop-up may be an overlay that is positioned on top of the other user interface elements on the screen in a more persistent manner. The pop-up can arise in response to a user input selecting the parent 635 and/or the child 637. The pop-up can persist until another user input is to close or minimize the preview. For example, a pop-over may be an overlay that is that is positioned on top of the other user interface elements on the screen in a more temporary manner. For example, the pop-over can occur for the duration of a user input (e.g., the duration of a touch input on touch screen display). In still other embodiments, the preview may occur within an expanded form of the procedure history 630, or in other embedded or non-embedded positions. In some embodiments, the procedure history 630 may include one or more thumbnail images for parents 635 and/or children 637. [0075] In some embodiments, the children 637 (e.g., saved frame and/or bookmark) and/or the measurements associated with the children 637 (e.g., length, diameter, area, FFR value, iFR value, flow value) were identified at a time prior to the user viewing the controller 600. For example, the saved image frame, bookmarked image frame, length measurement, area measurement, and/or diameter measurement were previously identified during acquisition and/or review of IVUS imaging data using screen displays dedicated to acquisition and/or review functions. The controller 600 advantageously identifies the previous measurements 635 in the history 630 alongside the respective measurements obtained during a selected measurement 635 in the preview 650. In some embodiments, the controller 600 can be a single user interface element or single screen display with the history 630 and preview 650 forming different portions thereof.

[0076] In some embodiments, children and even parents can be generated outside the procedure case log with dynamic preview. For example, this may occur within the IVUS modality, such that when the user returns to the case log, the new children and parents can be seen in the procedure history 630. In still other embodiments, it is possible to generate children 637 (e.g., a bookmarked or save frame) from within the procedure history 630 and/or the preview 650.

[0077] In the illustrated embodiment, both the selected parent 635 in the expanded mode and unselected parent 635 in the collapsed mode provide the user information about the respective measurement. For example, the unselected parents 635 in Fig. 6 (e.g., iFR pullback, iFR spot, FFR) include a numerical value 639 of the corresponding iFR or FFR. For example, for an iFR pullback, a distal iFR value (e.g., distal of a lesion in the vessel) can be provided. The numerical values can be provided with any suitable formatting, including color, shading, typeface, etc. In some embodiments, the numerical value associated with an iFR measurement can be displayed with different formatting than a numerical value associated with an FFR measurement to allow a user to more easily distinguish between the two. In some embodiments, the numerical values of the measurements can be color coded according to their severity (e.g., red for the more severe blockages, yellow for moderate block, green for less severe blockages or no blockage). In some embodiments, the color coding can be based on the numerical value of the measurement.

Because the controller screen 600 provides essential information about each measurement in a summary manner, the clinician can quickly and easily review information from multiple measurements at the same time to make a clinical decision about the patient. For example, multiple measurements can be the same or different modalities. For example, the clinician can review essential IVUS data from the selected IVUS video loop, while also simultaneously viewing the iFR and/or FFR values 639 shown in the history 630.

[0078] In some embodiments, the unexpanded parent may also provide information about the children. For example, a parent might include indications of how many bookmarks or saved frames are associated with it. In some instances, this may provide an indication to the user whether saved frames need to be generated. In other embodiments, the existence or nonexistence of children may be indicated by whether the parent includes a drop-down carat.

[0079] During a procedure, one or more measurements or sets of measurements may be obtained. For example, during a functional measurement, an iFR pullback and/or an iFR spot measurement may be performed. During a given imaging measurement, e.g., one, two, three or more IVUS pullbacks can be performed. The parents 635 can be the individual measurement runs during a given measurement (e.g., the iFR pullback, the iFR spot measurement, the first IVUS pullback, and the second IVUS pullback). In other instances, the procedure history 630 can be arranged so that parents 635 are the individual measurements (e.g., the functional measurement and the imaging measurements) and the children 637 are the individual measurement runs. In some embodiments, the procedure history 630 can also include grandchildren (e.g., saved frames and/or bookmarks within the measurement runs).

[0080] In the example shown in the figure, all the completed measurements 635 within the current procedure are shown in their collapsed mode except the selected measurement 635, an IVUS video loop, which is shown in an expanded mode displaying three children. In an example, the IVUS video loop is a tomographic image stack captured as an IVUS sensor is pulled back along a lumen 106. In the example shown, the three children are two saved frames and one bookmark. Each saved frame or bookmark may represent a single tomographic section in the tomographic stack, such that either or both of the time and position of the section is known.

[0081] The IVUS pullback can be performed at a constant rate, such as by a pullback device, or manually by a clinician. A processor circuit of, e.g., the processing system 572, can identify and store the time and position of each IVUS image or tomographic section. In some instances, the processor circuit can perform co-registration to identify the location of the each IVUS image frame along a length of a vessel in an extraluminal (e.g., radiographic, x-ray, angiographic, fluoroscopic, computed tomography or CT, magnetic resonance imaging or MRI) image. The computing device 172 and/or the processing system 572 can be in communication with one or more of the extraluminal imaging devices. In some embodiments, parents 635 may be multimodal. For example, an IVUS parent co-registered with x-ray data could give rise to an IVUS video loop child, which could in turn give rise to save frames and bookmarks as grandchildren. The same parent could give rise to an angiogram with displayed roadmap as a child. In this example, the two children represent two different modalities (IVUS and x- ray/angio). Multimodal data could also include combined pressure and flow data, or other combinations.

[0082] This parent/child configuration places the child data 637 hierarchically within the parent data 635, regardless of the time or sequence of the child data’s creation, thus placing the child data 637 where it is most logically accessible to a clinician. It also permits the clinician to see at a glance whether archivable data elements (e.g., saved frames) have been created for each parent measurement 635.

[0083] The procedure controller 600 also provides an interactive preview pane or preview window 650. In the example shown, the preview pane 650 is configured to provide an image pane 660 capable of showing a single frame or tomographic section 661 from a tomographic sequence. The preview pane 650 also includes a selector control 665 that allows a user (e.g., a clinician) to step backward and forward in the tomographic sequence. For example, the left and right arrows can be used to skip backward and forward in time and/or space during an IVUS pullback video capture, e.g., between bookmarked and/or saved frames to allow a clinician to efficiently view the important frames that he or she has identified from the IVUS pullback. The preview pane 650 can include a play/pause control 668 that starts or stops the movie or video loop of all of the image frames in the tomographic stack. In some instances, the image frames of the tomographic stack are visually represented by a line 669 representative of the time and/or vessel length over which the tomographic IVUS images were obtained. The preview pane 650 includes a bookmark 662 representing one of the children 637 of the currently selected parent 635, such as a single tomographic section of the tomographic stack that has been marked for particular emphasis and easy retrieval. The preview pane 650 also includes two data annotation markers 664, indicating that the frames or tomographic sections at those locations have data annotations (e.g., area or diameter measurements) marked on them. These annotated frames may be separately saved and/or bookmarked. Saved frames or tomographic sections may be archived, viewed, edited, emailed, copied into documents, etc. The bookmark 662 and annotated frames 664 can be provided on the line 669 to show their respective timing and/or positioning relative to other image frames. The bookmark 662 and saved frames 664 can be visually represented as tick marks extending perpendicular to the time line 669. While tick marks are shown in the illustrated embodiment, it is understood that the bookmark 662 and annotated frames 664 can be represented by any suitable shape or symbol, with any suitable color, pattern, shading, thickness, etc. In some embodiments, the representation of the bookmark 662 is visually different and distinguishable from the representation of the annotated frames 664, such as by a different color, pattern, shading, thickness, shape, symbol, etc. In some embodiments, the time line 669 includes a tick mark or other shape/symbol representative of the respective timing and/or positioning of the active image frame 661. In an example, when the user opens or selects a measurement or parent 635 from the procedure history 630, the image pane 660 opens to the currently displayed frame 661.

[0084] In the embodiment shown in the figure, the preview pane 650 is also configured to provide function buttons 670 that perform functions of viewing, deleting, or renaming parent or child data. In some embodiments, a function button 670 may be provided to generate child data automatically. For example, upon selection of the view option, the processor circuit provides a user interface that is dedicated to review of the selected data (e.g., a display with larger tomographic images, a longitudinal display of the IVTJS frames, measurement tools to make new measurements, etc.) Other functions and function buttons 670 are contemplated depending on the implementation. In the embodiment shown in the figure, the preview pane 650 also includes an information pane 680 that includes the name, date, guide wire type, and/or catheter type of the selected measurement 635. Other information items are contemplated, and may include clinician name(s), catheter serial numbers, patient status, pullback speed or distance, and otherwise depending on the implementation. In the example shown in the figure, the procedure controller 600 also provides a size indicator 690 for the selected parent 635, showing the total storage space (e.g., in megabytes) required to store the parent data and all child data for the selected parent 635. In other embodiments, other case data may be similarly displayed, such as the number of elements of each type (number of IVTJS video loops, iFR spot measurements, etc.) [0085] In some embodiments, numerical values for the measurements may be shown in the preview images. For example, the numerical value can be a length measurement, a diameter measurement, an area measurement, a percentage of narrowing/blockage within the lumen, and/or other suitable quantities. In that regard, different numerical values, corresponding to different types of measurements, can be provided for an imaging measurement than for a functional measurement. In some embodiments, the measurements are by default sorted with the newest on top, as a physician would prefer while conducting a procedure, but can be sorted with the oldest (first acquired) on top as one might prefer when reviewing the chronological history of the procedure at a later time. In some embodiments, measurements may be sorted and/or filtered by measurement type. For example, the controller 600 can include a selectable option for a user to cause the procedure history 630 to only show imaging measurements, only show functional measurements, and/or all measurements. In the embodiment shown in the figure, the preview pane or preview window 650 is displayed as part of the procedure controller 600. For example, the preview 650 is provided adjacent to the procedure history 630 in the screen display. The preview 650 is modified or updated according to the parent measurement 635 selected in the procedure history 630. In other embodiments, the preview pane or preview window 650 is displayed on a separate display device (e.g., a separate monitor or a handheld device).

[0086] As will be appreciated by one of ordinary skill in the art after becoming familiar with the teachings herein, the case menu or procedure controller 600 provides several functions in one place: diagnostic tool or modality selection, patient data entry, and data review. This novel arrangement of functions and data streamlines the tasks that must be performed by a clinician during and after an intravascular procedure, especially for complex procedures that involve a significant number of measurements of different types. For example, the controller screen display 600 provides the list of measurements and essential information about the measurements in an efficient manner for the clinician.

[0087] Figure 7 is an example procedure controller 600 with interactive case log 630 and interactive preview pane 650 according to at least one embodiment of the present disclosure. In the example shown in the figure, the image pane 660 of the preview 650 shows a tomographic section 661 representing a cross-sectional view of the lumen 506. The embodiment of Fig. 7 includes features similar to shown and described with respect to Fig. 6. Additionally, the preview 650 includes visual representations of one or more measurements on the IVTJS image frame 661. For example, the IVTJS image frame 661 can include one or more borders 740, 750 identifying a region within the anatomy. For example, the border 740 can be a lumen border while the border 750 can be a vessel border. The space between the borders illustrates the structure of the vessel. Since the inner and outer walls 740, 750 are not co-centric, and since the tomographic section shows an area of increased density 760 in between the inner and outer walls, a clinician can identify this particular tomographic section as clinically significant and save this frame, along with the measurements associated with that frame. The saved frame appears one of the children 637 under the parent 635. The measurements on the tomographic section 661 additionally include length and/or diameter measurements 730 across different portions of the vessel and/or lumen. The area, length, and/or diameters measurements can be illustrated as overlays on the tomographic section 661 showing their position and/or as numerical values in the preview pane 650. An indicator 720 shows the position of the imaging catheter within the vessel in the image frame 661.

[0088] The preview 650 includes a text area 710 allowing a user to add and/or modify a label for a parent 635 and/or the children 637. For example, the selected IVTJS pullback can be label LAD Mid Pre, which identifies the vessel name (left anterior descending or LAD artery), the segment of the vessel (middle or mid portion), and a timing (e.g., post or pre, to indicate that the IVTJS pullback was performed after or before a therapeutic procedure). In some embodiments, the label can also include name of the therapeutic procedure (among others, balloon, stent, so that a portion of the label is, e.g., pre-stent). The label can include text that is a selection from multiple options or can be free-form in that includes any text the user prefers. The label of the saved frames and bookmarked frames can identify why the clinician identified them as significant (e.g., a healthy or reference location of the vessel, location of a lesion, proximal/distal landing zone for stent, minimum lumen area measurement, healthy proximal and/or distal measurements, etc.). The labels of the parent 635 and/or the child 637 can be displayed in the history 630, as well as the preview 650 (e.g., when the parent 635 and/or the child 637 is selected). In that regard, any changes made in the field 710 are applied to the text label for the parent and/or child 637 in the history 630.

[0089] In some embodiments, the preview 650 provides measurements that a user previously performed on a different screen display (e.g., during IVTJS acquisition and/or review). For example, the user can select the open function option 670 to be shown a different screen display on which the user is provided additional options perform additional measurements or remove existing measurements. The preview 650 will be updated based on the changes made by the user. In other embodiments, the preview 650 allows the user to make measurements while on the controller screen 600. For example, measurement tools for area, length, and/or diameter measurement can be provided. Similarly, in some embodiments, the history 630 and/or the preview 650 displays saved frames 762 and/or bookmarked frames that were previously identified by the user on a different screen display. In other embodiments, new frames can be saved or bookmarked on the controller screen 600.

[0090] In some embodiments, the preview pane 650 and/or the history 630 can include a number of transformation tools that operate on the measurement. For example, the controller screen 600 can include a selectable option for a user to create a child 637 from a parent 635. A bookmarking tool and/or save frame tool can allow a user to add new children 637. For example, during playback of the IVUS sequence, the bookmarking tool and/or save frame tool can be selected to bookmark and/or save a particular tomographic section, such as to highlight an area of particular stenosis within the lumen 506. The tagging tool 710 within the preview pane 650 enables a user to label the selected child element (e.g., a tomographic section of an IVTJS pullback series) measurement with a note, comment, clinically relevant location, clinical instruction, or other relevant text. A measurement tool has been used to measure one or more dimensions of the lumen 506, such as a length, diameter, and/or area at the particular

longitudinal location along the length of the vessel represented in the tomographic section.

Other transformation tools are contemplated, including but not limited to a tool for placing text on frames, a tool for placing numerical measurements on frames, and a tool for colorizing different regions of a frame, based on Doppler data or otherwise.

[0091] Providing the preview screen 650 adjacent to the history 630, as well as providing the values 639 in the history, in the controller screen 600 advantageously reduces the amount of data the clinician needs to look at in order to make clinically relevant judgments and increases the readability and ease of interpretation of each child element (e.g., a tomographic section as shown in the figure) such that relevant clinical information is readily apparent at a glance. This also advantageously yields both a streamlined workflow and a highly functionalized output that would not be feasible without the intravascular procedure case log system with dynamic preview. In this regard the present disclosure enables procedures and post-procedure data reviews to be completed more quickly and with greater clinical confidence.

[0092] In Fig. 7, the parents 635 and the children 637 can always be visible in the history 630. For example, the children 637 can be visually distinguishable from the parents 635 in that the children 637 are indented relative to the parents 635. By keeping the parents 635 and the children 637 always visible in the history 630, a physician can easily and efficiently identify which parents do or do not have associated children 637. For example, if the parent 635 does not have a child based on the physician’s review of the history 630, the physician can create children 637 within the controller screen 600 and/or different display screen.

[0093] In Fig. 7, an indicator 763 is provided on the time line 669 showing the temporal and/or spatial position of the current frame 661 relative to other frames in the IVUS video 635.

In some embodiments, an elapsed portion of the timeline 669 is formatted differently (e.g., bolded or highlighted) than remaining portions of the timeline 669.

[0094] Figure 8 is an example procedure controller 600 with interactive case log 630 and interactive preview pane 650 according to at least one embodiment of the present disclosure. In the example shown in the figure, the selected parent measurement 810 is a functional measurement, such as an iFR pullback. The attributes column 820 can be provided in the case log 630. The attributes can identify relevant information about the each of the parent measurements, such as a numerical value and/or a quantity of bookmarks. For example, with respect to the iFR pullback 810, the attributes column 820 includes a field 870 including the numerical value of 0.84 (e.g., a distal iFR value, which represents the distal location within the vessel where the effect of any blockage(s) in the vessel is expected to be relatively larger than more proximal locations within the vessel) and a field 871 that there are two child elements (e.g., bookmarks) that have been created for this parent. For example, the bookmarks can be representative of two different locations along the vessel and/or the respective iFR values at those locations. The bookmarks can be clinically significant locations for the user, such as the locations where there is a drop in the pressure ratio, which can be indicative of a blockage in the vessel. While FFR and iFR are described with respect to some embodiments, any suitable pressure ratio is contemplated, including a Pd/Pa value, a pressure ratio with hyperemia, a pressure ratio without hyperemia, a pressure ratio based on pressure measurements within a portion of the cardiac cycle, and/or a pressure ratio based on pressure measurements over an entire cardiac cycle.

[0095] In this example, the preview pane 650 includes a summary pane 861 which shows a one or more numerical values (e.g., an iFR value). The summary pane 861 can also include a textual description associated with the numerical value (e.g., iFR distal). In some embodiments, the numerical value in the summary pane 861 can be modified based on user input. For example, when the parent 810 is first selected, the summary pane 861 can display a distal iFR value.

When a bookmark is selected, a different iFR value (e.g., representative of a different location along the vessel) associated with the bookmark can be displayed in the summary pane 861. In this example, a selector control 865 (e.g., left and right arrows) can be used to page back and forth through bookmarks created by the user. In various embodiments, the textual description of the iFR measurement 810 and/or the bookmarks can be added and/or modified in the field 710.

[0096] The preview 650 also includes a detail pane 862, which shows the complete iFR pullback in a graphical form 864. For example, the graphical form 864 can be a trendline 868 of the iFR values along a length of a vessel (e.g., pressure ratio or iFR on a vertical axis and time or distance on a horizontal axis). The bookmark indicators 867 are shown along the horizontal axis, illustrating the relative location of the bookmark locations along the trendline 864. In some embodiments, the iFR distal bookmark indicator 867 and/or the numerical value and/or textual description in the summary 861 can be colored differently from other bookmark indicators, as well as their corresponding numerical value and/or textual description in the summary 861, at different locations along the vessel. In some embodiments, the bookmarks associated with the iFR measurement 810 were previously added by a user on a different screen display. In other embodiments, the bookmarks can be added, modified, and/or deleted in the preview 650.

[0097] The detail pane 862 includes regions 869 that have been identified by a user. In some embodiments, the regions 869 were highlighted prior to viewing the preview 650, e.g., on a different screen display associated with acquiring and/or review iFR data. For example, selecting the view option 670 can cause the processor circuit to provide the user a more detail view of the selected iFR measurement 810 on which to make measurements, bookmarks, etc. In other embodiments, the regions 869 can be identified on the preview 650. The regions 869 identify a temporal and/or spatial portion associated with the pullback. The detail pane 862 can include numerical values 866 respectively associated with the regions 869. For example, each numerical value 866 can be the change in pressure ratio/iFR (e.g., pressure drop) within that particular region 869. The numerical values 866 and/or the regions 869 can be differently colored and/or otherwise formatted to be visually distinguishable to the user. In some embodiments, the numerical values 866 can be the vessel length associated with each of the regions 869.

[0098] The screen displays of Figs. 6-8 can be provided on any suitable display device, such as a bedside controller, a display integrated in a console (e.g., a movable cart), a surgical boom display, a laptop computer, a desktop computer, and/or a mobile device (e.g., tablet, mobile phone, etc.). For example, the screen displays can be provided on a touch screen display in communication with the processor circuit. User inputs can be provided directly on the touch screen display. In other embodiments, the processor circuit can be in communication with user interface devices, such as controllers with hard or soft buttons, scroll wheel, keyboard, mouse, etc. can be used.

[0099] In some embodiments, the parent element can be a pressure measurement, and the child elements can be associated with particular pressure ratios from the pressure measurement. In some embodiments, the parent element can be pressure measurement, and the child elements can be screen captures of one or more or all of the normalizations during the pressure measurement (e.g., when pressure reading of the distal pressure sensor on the gui dewire is equalized to the pressure reading on a proximal or aortic pressure sensor on the catheter). For example, an FFR/iFR data element on the history 630 can collect screen captures of every normalization.

[00100] Figure 9 is a schematic diagram of a processor circuit 950, according to embodiments of the present disclosure. The processor circuit 950 may be implemented for example in the computing device 172 of Figure 4 or the processing system 572 of Figure 5. As shown, the processor circuit 950 may include a processor 960, a memory 964, and a communication module 968. These elements may be in direct or indirect communication with each other, for example via one or more buses.

[00101] The processor 960 may include a central processing unit (CPU), a digital signal processor (DSP), an ASIC, a controller, an FPGA, another hardware device, a firmware device, or any combination thereof configured to perform the operations described herein. The processor 960 may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.

[00102] The memory 964 may include a cache memory (e.g., a cache memory of the processor 960), random access memory (RAM), magnetoresistive RAM (MRAM), read-only memory (ROM), programmable read-only memory (PROM), erasable programmable read only memory (EPROM), electrically erasable programmable read only memory (EEPROM), flash memory, solid state memory device, hard disk drives, other forms of volatile and non-volatile memory, or a combination of different types of memory. In an embodiment, the memory 964 includes a non-transitory computer-readable medium. The memory 964 may store instructions 966. The instructions 966 may include instructions that, when executed by the processor 960, cause the processor 960 to perform the operations described herein with reference to the computing device 172 (Fig 4), processing system 572 (Fig 5), or the equivalent. Instructions 966 may also be referred to as code. The terms“instructions” and“code” should be interpreted broadly to include any type of computer-readable statement(s). For example, the terms “instructions” and“code” may refer to one or more programs, routines, sub-routines, functions, procedures, etc.“Instructions” and“code” may include a single computer-readable statement or many computer-readable statements.

[00103] The communication module 968 can include any electronic circuitry and/or logic circuitry to facilitate direct or indirect communication of data between the processor circuit 950, the intraluminal instrument 175, 152 (Fig 4), or 502 (Fig 5), monitor 578 (Fig 5), and/or input devices known in the art such as mice, keyboards, touchscreen interfaces, gesture, and voice control interfaces. In that regard, the communication module 968 can be an input/output (I/O) device. In some instances, the communication module 968 facilitates direct or indirect communication between various elements of the processor circuit 950 and/or the computing device 172 (Fig 4) and/or the processing system 572 (Fig 5), or other computing or processing systems or devices depending on the implementation.

[00104] Figure 10 is a block diagram showing algorithmic steps of a method 1000 implementing an example intravascular procedure case log system with dynamic preview. The steps of the method 1000 can be performed by a processor circuit. In step 1001, the method 1000 includes receives a request from the user (e.g., a clinician) to initiate a new measurement. This triggers an intravascular instrument (for example, instrument 175 or instrument 152 of Fig 4, or the intraluminal device 502 of Figure 5) to generate either imaging data (1002) or a functional measurement (step 1003). The processor circuit receives the imaging data and/or a functional measurement. In some embodiments, additional co-registration inputs may be accepted such as x-ray, angiography, and/or fluoroscopy images (e.g., roadmap images) for co registration. In that regard, the processor circuit can be in communication with an extraluminal imaging device, such as an x-ray device, angiography device, fluoroscopy device, a CT device, an MRI. The processor circuit can be configured to co-register intraluminal data with the extraluminal images such that the locations along a length of vessel at which the intraluminal data is obtained is known.

[00105] As described hereinabove, such measurements may involve substantial amounts of time, data, and clinician labor to perform. In step 1010, once the measurement has been performed, the measurement can be associated, by the processor circuit, with the procedure within memory. In this manner, when the measurement is provided in a list of measurements displayed in the case log or measurement list 630, the imaging data or functional measurement is displayed associated with the respective measurement. In that regard, the processor circuit can generate display data corresponding to the case long 630. In step 1012, the method includes the processor circuit providing view controls (e.g., 665, 668, 865) that are appropriate to the captured data type or modality as described hereinabove. The user may select from these view controls, and this selection is received by the system in step 1014.

[00106] In step 1020, the user has the option of selecting a different parent measurement, or of retaining the current parent measurement selection. Such selection steps may be made for example through inputs of a mouse, keyboard, or touchscreen interface to activate buttons shown on a display as for example buttons 622 and 624 (see Fig 6). Alternatively, selections may be made by voice or gesture, with the understanding that such voice or gesture commands may simply substitute for the equivalent mouse, keyboard, or touchscreen inputs.

[00107] In step 1030, the selected parent measurement is placed in the preview pane as described hereinabove. In step 1040, the user selects one or more child elements (e.g., to be displayed in embodiments in which the child elements have already been created or to be created in embodiments in which the child elements have not been created), for example by clicking on particular time points on a play bar 668 or selector control 665, although other selection implementations may be used. Such child elements may include but are not limited to saved frames and bookmarks. In some embodiments, in step 1050, the child elements are created by the system as described hereinabove. In other embodiments, the child elements are retrieved from memory. In step 1060 the child elements are placed in the preview pane such that they can be viewed as part of the parent measurement. In step 1070, one or more controls (e.g., review control, transformation controls, etc.) are displayed that are appropriate to the modality, data type, measurement type, and/or child type. Such controls may include but are not limited to naming, tagging, highlighting, annotating, drawing, measuring, filtering, enhancing, and placement of measurement data in a tomographic section, saved frame, bookmarked frame, or functional measurement. In step 1080, the user selects one or more controls to apply to one or more child elements.

[00108] In step 1090, through a combination of view controls and controls, the user may select different child elements and apply changes to them (e.g., change a label associated with the child element). In step 1095, the transformed child elements are stored for easy retrieval, to aid the clinician in the efficient development of a treatment plan for the patient (e.g., stenting or other vascular interventions) while the procedure is still going on. In some embodiments, step 1060 may be repeated as the transformed child elements are added to the elements already on display in the preview pane. In an example, this process may continue for as long as the clinician desires or the needs of the patient require, and may be halted at any time and in any step by selecting the exit button 604 as described hereinabove.

[00109] The method 1000 advantageously allows for a large volume of raw data from the measurement is transformed into a small selection of highly readable patient-specific, case- specific treatment advisory images and/or data points. This clinician can directly review only the procedure controller screen 600, without the need to change screens, load different software, take notes, or otherwise interrupt the procedure or post-procedure analysis.

[00110] A person of ordinary skill in the art will appreciate that some of the steps described herein may be omitted or modified, or that other steps may be performed, or the steps may be performed in different sequences or interrelationships than those depicted in the figure, without departing from the subject matter of the current disclosure.

[00111] Such a person will further appreciate that in other embodiments, the case log system may be configured to accept numerous other modalities (video, photographic, and functional data types), including but not limited to pressure, flow (velocity), optical sensing, optical coherence tomography (OCT), infrared sensing, thermography and other temperature sensing, x-ray, chemosensing, forward looking intravascular ultrasound (FL-IVUS) imaging, intravascular photoacoustic (IVPA) imaging, intracardiac echocardiography (ICE), transesophageal echocardiography (TEE), an optical fiber, a reflector, a mirror, a prism, an ablation element, a radio frequency (RF) electrode, a conductor, and/or combinations thereof. The system may be configured to sort parents by modality, and may even filter parents such that one or more modalities are selected to be displayed, or excluded from display, or such that only data from particular times is displayed, or excluded from display. In an example, a clinician might want to see only IVTJS data from a particular time period, or might want to see everything except that particular IVTJS data from that particular time period.

[00112] In one embodiment, a device for intravascular measurement and data analysis of a patient, comprises: a processor; a display in communication with the processor; one or more instrumented intravascular catheters or guidewires in communication with the processor that are capable of making one or more intravascular measurements; a procedure controller algorithm running on the processor operating a procedure controller disposed within the display; a modality selector within the procedure controller, wherein selection of a modality initiates a new intravascular measurement; a case log disposed within the procedure controller, wherein the one or more intravascular measurements are disposed, and wherein a particular intravascular measurement may be selected from the log; one or more child creation tools that, when activated, cause the creation of one or more child elements of the one or more intravascular measurements; a preview pane disposed within the procedure controller, comprising: a data element of the particular intravascular measurement, function buttons, play controls, and transformation controls capable of either or both of reducing an amount of data to be reviewed or increasing readability and ease of interpretation of data to be reviewed.

[00113] In some embodiments, the one or more intravascular measurements are selected from IVTJS measurement, pressure measurements, and flow measurements. In some embodiments, the data element of the particular intravascular measurement comprises an IVTJS sequence, pressure measurement value, pressure measurement graph, flow measurement values (e.g., flow rate, flow velocity, flow direction, flow volume, etc.), or flow measurement graph. In some embodiments, the data element of the particular intravascular measurement is a child element comprising a bookmark or a saved tomographic section. In some embodiments, the transformation tools comprise a bookmarking tool, a tomographic section saving tool, a tagging tool, a probe locator tool, a measurement tool, an inner boundary marking tool, and an outer boundary marking tool. In some embodiments, the device provides an ability for an operator to perform all functions of the device without changing screens, windows, or tabs on the display.

In some embodiments, the function buttons comprise the ability to delete, open, or rename a data element. In some embodiments, the device further comprises patient information; an exit button to end a procedure; a functional menu activator; a size indicator; a logo. In some embodiments, the case log further comprises an attributes column stating one or more attributes of each of the one or more intravascular measurements in the case log.

[00114] In one embodiment, a method for improving intravascular measurement and data analysis of a patient, comprises: providing a processor; providing a display; providing one or more instrumented intravascular catheters or guidewires capable of making one or more intravascular measurements; providing a procedure controller disposed within the display that is operated by an algorithm running on the processor and in communication with the one or more instrumented intravascular catheters or guidewires; providing a modality selector within the procedure controller, wherein selection of a modality initiates a new intravascular measurement; providing a case log disposed within the procedure controller, wherein the one or more intravascular measurements are disposed, and wherein a particular intravascular measurement may be selected from the log; within the case log, providing an attributes column stating one or more attributes of each of the one or more intravascular measurements in the case log; providing one or more child creation tools; creating one or more child elements of the one or more intravascular measurements when one or more child creation tools are activated; previewing information and controls within the procedure controller, comprising: a data element of the particular intravascular measurement, function buttons, play controls, and transformation tools comprising: a bookmarking tool, a tomographic section saving tool, a tagging tool; a probe locator tool; a measurement tool; an inner boundary marker, and an outer boundary marker, such that a clinician may generate, reduce, increase the readability and ease of interpretation of, and save intravascular measurement data, without a need to change screens, windows, or tabs on the display.

[00115] In some embodiments, the one or more intravascular measurements are selected from IVUS measurement, pressure measurements, and flow measurements. In some embodiments, the data element of the particular intravascular measurement comprises an IVUS sequence, pressure measurement value, pressure measurement graph, flow measurement values, or flow measurement graph. In some embodiments, the data element of the particular intravascular measurement is a child element comprising a bookmark or a saved tomographic section. In some embodiments, the function buttons comprise the ability to delete, open, or rename a data element. In some embodiments, the method further comprises: displaying patient information within the procedure controller; an exit button to end a procedure; a functional menu activator; a size indicator; a logo.

[00116] In one embodiment, a system for intravascular measurement and data analysis of a patient, comprises: a processor; a display; one or more instrumented intravascular catheters or guidewires capable of making one or more intravascular measurements; a processor in communication with both the display and the one or more instrumented intravascular catheters; an algorithm running on the processor; a procedure controller disposed within the display and operated by the algorithm; a modality selector within the procedure controller, wherein selection of a modality initiates a new intravascular measurement; a case log disposed within the procedure controller, wherein the one or more intravascular measurements are disposed, and wherein a particular intravascular measurement may be selected from the log; an attributes column within the case log, stating one or more attributes of each of the one or more

intravascular measurements in the case log; one or more child creation tools that, when activated, cause the creation of one or more child elements of the one or more intravascular measurements; providing a preview pane disposed within the procedure controller, comprising: a data element of the particular intravascular measurement, play controls, and transformation tools comprising: a bookmarking tool, a tomographic section saving tool, a tagging tool; a probe locator tool; a measurement tool; an inner boundary marker, and an outer boundary marker, such that a clinician may generate, reduce, increase the readability and ease of interpretation of, and save intravascular measurement data, without a need to change screens, windows, or tabs on the display.

[00117] In some embodiments, the one or more intravascular measurements are selected from IVUS measurement, pressure measurements, and flowrate measurements. In some

embodiments, the data element of the particular intravascular measurement comprises an IVUS sequence, one or more pressure measurement values, a pressure measurement graph, one or more flow measurement values, or a flow measurement graph. In some embodiments, the data element of the particular intravascular measurement is a child element comprising a bookmark or a saved tomographic section. In some embodiments, the system further includes patient information displayed within the procedure controller; an exit button to end a procedure; a functional menu activator; a size indicator; a logo; function buttons comprising the ability to delete, open, or rename a data element.

[00118] Figure 11 is an example procedure controller 600 with interactive case log 630 and interactive preview pane 650 according to at least one embodiment of the present disclosure.

The embodiment of Fig. 11 includes features similar to those shown and described with respect to Figure 8. In the example shown in Figure 11, a saved frame child element has been selected for a pressure measurement. An image pane 1160 within the interactive preview pane 650 contains a variety of functional information that will be described in more detail in Figure 12. Also visible are a textual description field 710 and selector control 865. In some embodiments, the preview 650 can include a screen shot associated with the selected parent and/or child. The screen shot can be from a different screen associated with acquisition and/or review of the modality data.

[00119] Figure 12 is an example procedure controller 600 with interactive case log 630 and interactive preview pane 650 according to at least one embodiment of the present disclosure. The embodiment of Fig. 12 includes features similar to those shown and described with respect to Figures 8 and 11. In the example shown in Figure 12, a pop-up window 1260 contains a summary pane 861, a textual description field 710, a selector control 865, and a graph 864 that includes a trendline 868. Also visible within the graph 864 are a marker line 1261 indicating a particular time or distance along the trendline 868, and a text box 1261 containing a pressure value associated with the marker line. Visible in the lower portion of the pop-up window 1260 are the waveforms 1268 and 1269 of the pressure measurement along the trendline, representing the proximal and distal pressures, respectively.

[00120] Figure 13 is an example procedure controller 600 with interactive case log 630 and interactive preview pane 650 according to at least one embodiment of the present disclosure.

The embodiment of Fig. 13 includes features similar to those shown and described with respect to Figures 8, 11, and 12. In the example shown in Figure 13, the trendline 868 in the graph 864 has not been annotated with marker lines or text boxes. A summary pane 861 displays a pressure value across the trendline 868. Also visible are the proximal and distal pressure waveforms 1268 and 1269.

[00121] Figure 14 is an example procedure controller 600 with interactive case log 630 and interactive preview pane 650 according to at least one embodiment of the present disclosure.

The embodiment of Figure 14 includes features similar to those shown and described with respect to Figures 8 and 11-13. A summary pane 861 displays a pressure value (in this example, an iFR spot value), while the proximal and distal pressure waveforms 1268 and 1269 represent the raw measurement data used to compute the pressure value.

[00122] Figure 15 is an example procedure controller 600 with interactive case log 630 and interactive preview pane 650 according to at least one embodiment of the present disclosure.

The embodiment of Fig. 15 includes features similar to those shown and described with respect to Figure 7. Visible is a tomographic section 661 representing a cross-sectional view of a lumen 506 (e.g., a blood vessel), tagged with a textual description field 710. Within the tomographic section 661 are an imaging catheter position indicator 720, length and/or diameter measuring tools 730, a lumen inner wall 740 and outer wall 750. Further annotating and transforming the tomographic section are numerical values 1510 associated with the length and/or diameter measurements 730. In an example, the numerical values 1510 are distance measurements in millimeters, representing the lengths of the measurement tools 730 visible within the

tomographic section 661.

[00123] Additionally visible within the tomographic section 661 are vessel boundary indicators 1520 representing, for example, the shapes of the vessel inner boundaries 740 at different positions (i.e., different tomographic sections) within the lumen 506. The tomographic section 661 further includes numerical values 1530 associated with the vessel boundary indicators 1520. In an example, each grouping of numerical values 1530 includes a minimum diameter, a maximum diameter, and a cross-sectional area for the given location within the lumen 506. The numerical value(s) of the difference(s) between one or more of the

measurements can also be provided in the preview. Depending on the implementation, other values could be displayed instead of or in addition to these values.

[00124] Persons skilled in the art will recognize that the apparatus, systems, and methods described above can be modified in various ways. Accordingly, persons of ordinary skill in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the particular exemplary embodiments described above. In that regard, although illustrative embodiments have been shown and described, a wide range of modification, change, and substitution is contemplated in the foregoing disclosure. It is understood that such variations may be made to the foregoing without departing from the scope of the present disclosure. Accordingly, it is appropriate that the appended claims be construed broadly and in a manner consistent with the present disclosure.

Claims

CLAIMS What is claimed is:

1. An intravascular sensing system, comprising:

a processor circuit configured to be in communication with a display and an intravascular catheter or guidewire, wherein the intravascular catheter or guidewire is configured to be positioned within a blood vessel of a patient and comprises a sensor configured to obtain intravascular data while positioned within the blood vessel, wherein the intravascular data comprises at least one of intravascular ultrasound (IVUS) imaging data or pressure data, and wherein the processor circuit is further configured to:

receive the intravascular data from a plurality of intravascular measurements for a patient;

receive a user input corresponding to the selection of one of the plurality of intravascular measurements;

generate a screen display comprising:

a list of the plurality of intravascular measurements for the patient; and a visual representation of the intravascular data associated with the selection of one of the plurality of intravascular measurements, wherein the visual representation of the intravascular data is provided adjacent to the list of the plurality of intravascular measurements; and

output the screen display to the display.

2. The intravascular sensing system of claim 1,

wherein the processor circuit is configured to receive a user input corresponding to the selection of a different one of the plurality of intravascular measurements,

wherein the processor circuit generating the screen display includes modifying the visual representation of the intravascular data to be associated with the selection of the different one of the plurality of intravascular measurements.

3. The intravascular sensing system of claim 2, wherein the one of the plurality of intravascular measurements and the different one of the plurality of intravascular measurement comprise different modalities.

4. The intravascular sensing system of claim 1,

wherein the screen display comprises a single user interface element,

wherein the list of the plurality of intravascular measurements is provided on a first portion of single user interface element, and

wherein the visual representation of the intravascular data is provided on an adjacent second portion of the single user interface element.

5. The intravascular sensing system of claim 1,

wherein the list of the plurality of intravascular measurements for the patient comprises a numerical value of a measurement associated with one or more of the plurality of intravascular measurements.

6. The intravascular sensing system of claim 5, wherein the measurement value comprises a pressure ratio corresponding to a pressure intravascular measurement.

7. The intravascular sensing system of claim 5, wherein the measurement value is provided proximate to a text label identifying a respective intravascular measurement in the list of the plurality of intravascular measurements.

8. The intravascular sensing system of claim 1, wherein, when the selection of one of the plurality of intravascular measurements is associated with an IVTJS imaging measurement, the visual representation of the intravascular data comprises a tomographic image of the blood vessel, provided adjacent to the list of the plurality of intravascular measurements.

9. The intravascular sensing system of claim 8, wherein the visual representation of the intravascular data comprises at least one of an area measurement or a length measurement associated with the blood vessel, provided adjacent to the list of the plurality of intravascular measurements.

10. The intravascular sensing system of claim 8, wherein the list of the plurality of intravascular measurements comprises a numerical value of a pressure ratio associated with a pressure intravascular measurement such that the numerical value of the pressure ratio is provided proximate to the tomographic image frame in the screen display.

11. The intravascular sensing system of claim 1, wherein, when the selection of one of the plurality of intravascular measurements is associated with a pressure intravascular measurement, the visual representation of the intravascular data comprises at least one of a trendline of a pressure ratio or a numerical value of the pressure ratio, provided adjacent to the list of the plurality of intravascular measurements.

12. The intravascular sensing system of claim 11, wherein the visual representation of the intravascular data comprises numerical value representative of a change in the pressure ratio in a selected portion of the trendline, provided adjacent to the list of the plurality of intravascular measurements.

13. The intravascular sensing system of claim 1, wherein the list of the plurality of intravascular measurements comprises a hierarchical list including a first level element associated with each of the plurality of intravascular measurements and a second level element comprising the intravascular data associated with a respective intravascular measurement.

14. The intravascular sensing system of claim 13, wherein, when the respective intravascular measurement comprises an intravascular imaging measurement, the second level element comprises at least one of a bookmarked tomographic image frame or a saved tomographic image.

15. The intravascular sensing system of claim 14,

wherein the processor circuit is configured to receive a user input corresponding to the selection of the least one of a bookmarked tomographic image frame or a saved tomographic image,

wherein the processor circuit generating the screen display includes modifying the visual representation of the intravascular data to display the least one of a bookmarked tomographic image frame or a saved tomographic image, adjacent to the list of the plurality of intravascular measurements.

16. The intravascular sensing system of claim 13, wherein, when the respective intravascular measurement comprises a pressure intravascular measurement, the second level element comprises a bookmarked pressure ratio.

17. The intravascular sensing system of claim 16,

wherein the processor circuit is configured to receive a user input corresponding to the selection of the bookmarked pressure ratio,

wherein the processor circuit generating the screen display includes modifying the visual representation of the intravascular data to display the bookmarked pressure ratio, adjacent to the list of the plurality of intravascular measurements.