阅读说明：本技术 血管内成像流程特异性工作流程引导和相关联的设备、系统和方法 (Intravascular imaging procedure-specific workflow guidance and associated devices, systems, and methods ) 是由 N·S·拉伊古鲁 A·科恩 S·R·陈 赵沛然 于 2019-07-19 设计创作，主要内容包括：提供了用于提供流程特异性工作流程引导的系统、设备和方法。工作流程引导可以包括在显示设备上向用户提供可选择选项,包括用于选择目标血管的可选择选项和在选定的目标血管内移动血管内成像设备的提示。成像数据从选定的目标血管内的血管内成像设备接收。工作流程引导可以被用于识别选定的目标血管内的感兴趣区域并且在所述显示设备上自动显示与所述感兴趣区域相对应的血管测量结果。(Systems, devices, and methods for providing procedure-specific workflow guidance are provided. The workflow guidance may include providing selectable options to a user on a display device, including a selectable option for selecting a target vessel and a prompt to move an intravascular imaging device within the selected target vessel. Imaging data is received from an intravascular imaging device within a selected target vessel. Workflow guidance may be used to identify a region of interest within a selected target vessel and automatically display vessel measurements corresponding to the region of interest on the display device.)

1. An intravascular imaging system comprising:

a controller in communication with an intravascular imaging device, the controller configured to:

providing a selectable option on a display device in communication with the controller for selecting a target blood vessel;

providing a prompt to move the intravascular imaging device within a selected target vessel;

receiving imaging data from an imaging sensor during movement of the intravascular imaging device within the selected target vessel;

identifying a region of interest within the selected target vessel based on the received imaging data; and is

Automatically displaying, on the display device, a vessel measurement corresponding to the region of interest in response to identifying the region of interest.

2. The intravascular imaging system of claim 1, further comprising:

the intravascular imaging device, comprising:

a flexible elongate member configured to be inserted into the target vessel of a patient;

the imaging sensor disposed on a distal portion of the flexible elongate member; and

the display device.

3. The intravascular imaging system of claim 1, wherein the controller is further configured to provide selectable options on the display device for performing a pre-stent procedure or post-stent examination.

4. The intravascular imaging system of claim 1, wherein the controller is further configured to: automatically measuring a diameter of a blood vessel within the region of interest; determining a first location within the region of interest having a minimum diameter; and displaying the first location and the minimum diameter on the display device.

5. The intravascular imaging system of claim 1, wherein the display of the vessel measurements is configured to allow a user to edit the delineation of the boundaries of a vessel.

6. The intravascular imaging system of claim 5, wherein the display of the vascular measurements includes a first view of the region of interest and a second view of the region of interest that is different than the first view.

7. The intravascular imaging system of claim 6, wherein user edits to the depiction of the boundary of a vessel are displayed in the first and second views of the region of interest.

8. The intravascular imaging system of claim 3, wherein the display of the vascular measurements with user selection of a pre-stent procedure option includes a depiction of a target region for a stent.

9. The intravascular imaging system of claim 3, wherein the display of the vascular measurements with a user selected post-stent examination option includes a depiction of a stent.

10. The intravascular imaging system of claim 9, wherein the display of the vascular measurements includes a depiction of stent ectopy.

11. A method of intravascular imaging, comprising:

providing, on a display device, a selectable option for selecting a target vessel within a patient with a controller in communication with an intravascular imaging device;

providing, with the controller, a prompt on the display device to move the intravascular imaging device within the selected target vessel;

receiving, with the controller, imaging data from an imaging sensor as the intravascular imaging device moves within the selected target vessel;

identifying, with the controller, a region of interest within the selected target vessel based on the received imaging data; and is

Automatically displaying, with the display device, a vessel measurement corresponding to the region of interest.

12. The method of claim 11, further comprising providing, with the controller, selectable options on the display device for performing a pre-stent procedure or post-stent examination.

13. The method of claim 11, further comprising:

measuring a diameter of the blood vessel within the region of interest with the controller,

identifying a first location within the region of interest having a minimum diameter; and is

Displaying the first location and the minimum diameter on the display device.

14. The method of claim 11, further comprising providing, with the controller, an option on the display device for editing the delineation of the boundary of the blood vessel.

15. The method of claim 14, wherein the display of the vascular measurements includes a first view of the region of interest and a second view of the region of interest different from the first view.

16. The method of claim 15, further comprising displaying edits to the depiction of the boundary of the vessel in the first view and the second view of the region of interest.

17. The method of claim 16, further comprising displaying an edit to the depiction of the boundary of the vessel in a third view that is different from the first view and the second view.

18. The method of claim 12, wherein the display of the vessel measurements with user selection of a pre-stent procedure option includes a depiction of a target region for a stent.

19. The method of claim 12, wherein the display of the vessel measurements with a user selecting a post-stent inspection option includes a depiction of a stent.

20. The method of claim 19, wherein the display of the vascular measurements comprises a depiction of stent ectopy.

Technical Field

The present disclosure relates generally to obtaining intravascular data associated with a body vessel of a patient, and in particular to providing a workflow to a user to perform an intravascular imaging procedure with an intravascular imaging device. The workflow may be displayed to the user as prompts and instructions and visualizations of imaging data from the intravascular imaging device.

Background

Various types of intravascular imaging systems are used in diagnosing and treating disease. For example, intravascular ultrasound (IVUS) imaging is widely used in interventional cardiology as a diagnostic tool for evaluating diseased vessels, such as arteries, in the human body to determine the need for diagnosis, to guide the intervention, and/or to evaluate its effectiveness. An IVUS device including one or more ultrasound transducers is delivered into a blood vessel and guided to a region to be imaged. The transducer transmits ultrasound energy and receives ultrasound echoes reflected from the blood vessel. The ultrasound echoes are processed to create an image of the vessel of interest.

The advent of faster computational analysis has increased the effectiveness of intravascular imaging systems. However, existing intravascular imaging systems typically require a high degree of skill and experience from the operator to safely operate the intravascular device. For example, depending on the type of operation, the execution of an intravascular procedure may include a number of steps including manipulation of the device, measurement, and analysis of the results. The operator must know and complete all of these steps to successfully execute the procedure. The large number and complexity of steps may make these flows difficult to perform and may cause errors in the flows.

Disclosure of Invention

Systems, devices, and methods for providing instructions to an operator of an intravascular imaging system are provided. The intravascular imaging system can include: a controller configured to provide a selectable option on a display device to select a target vessel; identifying a region of interest within the selected target vessel based on the received imaging data; and automatically displaying, on the display device, a vessel measurement corresponding to the region of interest in response to identifying the region of interest. Aspects of the present disclosure advantageously provide a complete end-to-end workflow solution that overcomes the limitations of existing intravascular imaging systems.

Embodiments of the present disclosure provide an intravascular imaging system, which may include: a controller in communication with an intravascular imaging device, the controller configured to: providing a selectable option on a display device in communication with the controller to select a target vessel; providing a prompt to move the intravascular imaging device within a selected target vessel; receiving imaging data from an imaging sensor during movement of the intravascular imaging device within a selected target vessel; identifying a region of interest within the selected target vessel based on the received imaging data; and automatically showing on the display device a vascular measurement corresponding to the region of interest in response to identifying the region of interest.

In an embodiment, the intravascular imaging system further comprises the intravascular imaging device, comprising: a flexible elongate member configured to be inserted into a target vessel of a patient; the imaging sensor disposed on a distal portion of the flexible elongate member; and the display device. The controller may also be configured to provide selectable options on the display device to perform a pre-stent procedure or post-stent examination. The controller may be further configured to: automatically measuring a diameter of a blood vessel within the region of interest; determining a first location within the region of interest having a minimum diameter; and displaying the first location and the minimum diameter on the display device.

In some embodiments, the display of the vessel measurements is configured to allow a user to edit the delineation of the boundary of the vessel. The display of the vascular measurements may include a first view and a second view of a region of interest different from the first view. User edits to the delineation of the boundaries of the vessel may be displayed in the first view and the second view of the region of interest. The display of the vessel measurements may include a depiction of a target region for a stent if a user selects a pre-stent procedure option. The display of the vascular measurements may include a depiction of a stent if a user selects a post-stent examination option. The display of the vascular measurements may also include a depiction of stent ectopy.

Also provided is a method of intravascular imaging, which may include: providing, with a controller in communication with an intravascular imaging device, a selectable option on a display device to select a target vessel within a patient; providing, with the controller, a prompt on the display device to move the intravascular imaging device within the selected target vessel; receiving, with the controller, imaging data from an imaging sensor as the intravascular imaging device moves within a selected target vessel; identifying, with the controller, a selected region of interest within the target vessel based on the received imaging data; and automatically displaying, with the display device, the vessel measurements corresponding to the region of interest.

The method may further comprise: a selectable option is provided on the display device with the controller to perform a pre-stent procedure or a post-stent examination. The method may include: measuring, with the controller, a diameter of a blood vessel within the region of interest; identifying a first location within the region of interest having a minimum diameter; and displaying the first position and the minimum diameter on the display device. The method may include: providing, with the controller, an option on the display device to edit the delineation of the boundary of the blood vessel.

In some embodiments, the display of the vascular measurements includes a first view and a second view of a region of interest different from the first view. The method may include: displaying edits to the delineation of the boundaries of the blood vessel in the first view and the second view of the region of interest. The method may include: displaying an edit to the delineation of the boundary of the blood vessel in a third view different from the first view and the second view. The display of the vessel measurements may include a depiction of a target region for a stent if a user selects a pre-stent procedure option. The display of the vascular measurements may include a depiction of a stent if a user selects a post-stent examination option. The display of the vascular measurements may also include a depiction of stent ectopy.

Additional aspects, features and advantages of the present disclosure will become apparent from the detailed description that follows.

Drawings

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

fig. 1 is a diagrammatic, schematic view of an intravascular imaging system according to aspects of the present disclosure.

Fig. 2 is an exemplary illustration of a display showing a prompt in accordance with aspects of the present disclosure.

Fig. 3 is an exemplary illustration of a display showing another prompt in accordance with aspects of the present disclosure.

Fig. 4 is an exemplary diagram illustrating a display of another prompt and instruction in accordance with aspects of the present disclosure.

Fig. 5 is an exemplary illustration showing a display of imaging data and instructions, in accordance with aspects of the present disclosure.

Fig. 6 is an exemplary illustration showing a display of imaging data, in accordance with aspects of the present disclosure.

Fig. 7A is an exemplary illustration of a display showing various views of imaging data, in accordance with aspects of the present disclosure.

Fig. 7B is an exemplary illustration of another display showing various views of imaging data, in accordance with aspects of the present disclosure.

Fig. 7C is an exemplary illustration of another display showing various views of imaging data, in accordance with aspects of the present disclosure.

Fig. 8 is an exemplary illustration showing a display of imaging data, in accordance with aspects of the present disclosure.

Fig. 9 is an exemplary illustration showing a display of imaging data, in accordance with aspects of the present disclosure.

Fig. 10 is a flow diagram of a method of providing a guided workflow in accordance with an aspect of the present disclosure.

Detailed Description

For the purposes of promoting an understanding of the principles of the disclosure, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is intended. Any alterations and further modifications in the described devices, systems, and methods, and any further applications of the principles of the disclosure are contemplated 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 in connection with one embodiment may be combined with the features, components, and/or steps described in connection with other embodiments of the present disclosure. For the sake of brevity, however, many iterations of these combinations will not be described separately.

Fig. 1 is a diagrammatic, schematic view of an intravascular imaging system 100 according to aspects of the present disclosure. The intravascular imaging system 100 may include an intravascular device 102, a Patient Interface Module (PIM)104, a console or processing system 106, and a display device or monitor 108. The intravascular device 102 can be sized and shaped, and/or otherwise structurally arranged or configured to be positioned within a body lumen 120 of a patient. For example, in various embodiments, the intravascular device 102 may be a catheter, a guidewire, a guide catheter, a pressure line, and/or a flow line. In some cases, system 100 may include additional elements and/or may be implemented without one or more of the elements illustrated in fig. 1.

The apparatus, systems, and methods described herein may include one or more features described in U.S. provisional application No. __________ (attorney docket No. 2017PF02102), U.S. provisional application No. __________ (attorney docket No. 2017PF02103), U.S. provisional application No. __________ (attorney docket No. 2017PF02101), and U.S. provisional application No. __________ (attorney docket No. 2017PF02365), all of which are incorporated herein by reference in their entirety, filed on the same day.

The intravascular imaging system 100 (or intraluminal imaging system) may be any type of imaging system suitable for use in the lumen or vasculature of a patient. In some embodiments, the intravascular imaging system 100 is an intravascular ultrasound (IVUS) imaging system. In other embodiments, the intravascular imaging system 100 may include a system configured for forward looking intravascular ultrasound (FL-IVUS) imaging, intravascular photoacoustic (IVPA) imaging, intracardiac echocardiography (ICE), transesophageal echocardiography (TEE), and/or other suitable imaging modalities.

It should be appreciated that the system 100 and/or the device 102 may be configured to obtain any suitable intravascular imaging data. In some embodiments, device 102 may include imaging components of any suitable imaging modality, such as optical imaging, Optical Coherence Tomography (OCT), and the like. In some embodiments, device 102 may include any suitable imaging components, including pressure sensors, flow sensors, temperature sensors, optical fibers, reflectors, mirrors, prisms, ablation elements, Radio Frequency (RF) electrodes, conductors, and/or combinations thereof. In general, device 102 may include an imaging element that obtains intravascular data associated with lumen 120. The device 102 may be sized and shaped (and/or configured) for insertion into a patient's blood vessel or lumen 120.

The system 100 may be deployed in a medical laboratory having a control room. The processing system 106 may be located in a control room. Optionally, the processing system 106 may be located elsewhere, such as in the catheter lab itself. The catheter lab may include a sterile field, while its associated control room may or may not be sterile depending on the procedure and/or healthcare facility to be performed. The catheter lab and control room may be used to perform any number of medical imaging procedures, such as angiography, fluoroscopy, CT, IVUS, Virtual Histology (VH), forward looking IVUS (FL-IVUS), intravascular photoacoustic (IVPA) imaging, Fractional Flow Reserve (FFR) determination, Coronary Flow Reserve (CFR) determination, Optical Coherence Tomography (OCT), computed tomography, forward looking intracardiac echocardiography (ICE), forward looking ICE (flici), intravascular imaging, transesophageal ultrasound, fluoroscopy, and other medical imaging modalities, or a combination thereof. In some embodiments, the device 102 may be controlled from a remote location (such as a control room) so that the operator need not be in close proximity to the patient.

The intravascular device 102, PIM 104, and monitor 108 may be directly or indirectly communicatively coupled to the processing system 106. These elements may be communicatively coupled to the medical processing system 106 via a wired connection, such as a standard copper link or a fiber optic link, and/or via a wireless connection using the IEEE 802.11Wi-Fi standard, the Ultra Wideband (UWB) standard, the FireWire (FireWire), the wireless USB, or another high-speed wireless network standard. The processing system 106 may be communicatively coupled to one or more data networks, such as a TCP/IP based Local Area Network (LAN). In other embodiments, a different protocol may be utilized, such as Synchronous Optical Network (SONET). In some cases, the processing system 106 may be communicatively coupled to a Wide Area Network (WAN). The processing system 106 may utilize a network connection to access various resources. For example, the processing system 106 may communicate with a digital imaging and communications in medicine (DICOM) system, a Picture Archiving and Communications System (PACS), and/or a hospital information system via a network connection.

At a high level, the intravascular device 102 emits ultrasound energy from a transducer array 124 included in the scanner assembly 110, or the hospital assembly 110 is mounted near the distal end of the intravascular device 102. The ultrasound energy is reflected by tissue structures in the medium surrounding the scanner assembly 110, such as the lumen 120, and ultrasound echo signals are received by the transducer array 124. The scanner assembly 110 generates electrical signal(s) representing ultrasound echoes. The scanner assembly 110 may include one or more individual 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, and so forth. For example, in some instances, the scanner assembly 110 can be a one-dimensional array or a two-dimensional array. In some instances, the scanner assembly 110 may be a rotational ultrasound device. The active area of the scanner assembly 110 may include one or more segments (e.g., one or more rows, one or more columns, and/or one or more orientations) of one or more transducer materials and/or ultrasound elements that may be controlled and activated in unison or independently. The active area of the scanner assembly 110 can be patterned or structured in various basic or complex geometries. The scanner assembly 110 may be disposed in a side-looking orientation (e.g., ultrasound energy emitted perpendicular and/or orthogonal to a longitudinal axis of the intravascular device 102) and/or a front-looking orientation (e.g., ultrasound energy parallel and/or along the longitudinal axis). In some examples, the scanner assembly 110 is structurally arranged to transmit and/or receive ultrasound energy in a proximal or distal direction at an oblique angle relative to the longitudinal axis. In some embodiments, the ultrasound energy emission may be electronically steered by selective triggering of one or more transducer elements of the scanner assembly 110.

The ultrasound transducer(s) of the scanner assembly 110 can be Piezoelectric Micromachined Ultrasound Transducers (PMUTs), Capacitive Micromachined Ultrasound Transducers (CMUTs), single crystals, lead zirconate titanate (PZT), PZT composites, other suitable transducer types, and/or combinations thereof. In embodiments, the ultrasound transducer array 124 may include any number of individual transducers between 1 transducer and 1000 transducers, including values such as 2 transducers, 4 transducers, 36 transducers, 64 transducers, 128 transducers, 500 transducers, 812 transducers, and/or other values that are larger and smaller.

PIM 104 transmits the received echo signals to processing system 106 where the ultrasound images (including flow information) are reconstructed and displayed on monitor 108. The console or processing system 106 may include a processor and memory. The processing system 106 may be operable to facilitate the features of the intravascular imaging system 100 described herein. For example, a processor may execute computer readable instructions stored on a non-transitory tangible computer readable medium.

The PIM 104 facilitates communication of signals between the processing system 106 included in the intravascular device 102 and the scanner assembly 110. The communication may include: provide commands to integrated circuit controller chip(s) within the intravascular device 102; selecting particular element(s) on the transducer array 124 to be used for transmission and reception; providing a transmit trigger signal 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 accept amplified echo signals received from selected transducer array element(s) via amplifiers included on the integrated circuit controller chip(s). In some embodiments, the PIM 104 performs preliminary processing of the echo data prior to relaying the data to the processing system 106. In an example of such an embodiment, PIM 104 performs amplification, filtering, and/or aggregation of data. In an embodiment, the PIM 104 also supplies high and low voltage DC power to support operation of the intravascular device 102 including circuitry within the scanner assembly 110.

The processing system 106 receives echo data from the scanner component 110 via the PIM 104 and processes the data to reconstruct an image of tissue structures in the medium surrounding the scanner component 110. In general, the device 102 may be utilized within any suitable anatomical and/or body lumen of a patient. The processing system 106 outputs image data such that an image of the vessel or lumen 120 (such as a cross-sectional IVUS image of the lumen 120) is displayed on the monitor 108. Lumen 120 may represent both natural and man-made fluid-filled or surrounding structures. The lumen 120 may be within the body of the patient. Lumen 120 may be a blood vessel, such as an artery or vein of the patient's vascular system, including the heart vasculature, peripheral vasculature, neural vasculature, renal vasculature, and/or any other suitable lumen within the body. For example, device 102 may be used to examine any number of anatomical locations and tissue types, including but not limited to organs including liver, heart, kidney, gall bladder, pancreas, lung; a conduit; a bowel; nervous system structures including the brain, the dura mater sac, the spinal cord and the 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 102 may be used to examine artificial structures such as, but not limited to, heart valves, stents, shunts, filters, and other devices.

The processing system or controller 106 may include processing circuitry having one or more processors in communication with memory and/or other suitable tangible computer-readable storage media. The processing system or controller 106 may be configured to perform one or more aspects of the present disclosure. In some embodiments, the processing system 106 and the monitor 108 are separate components. In other embodiments, the processing system 106 and the monitor 108 are integrated into a single component. For example, the system 100 may include a touch screen device including a housing having a touch screen display and a processor. The system 100 may include any suitable input device, such as a touch sensitive pad or touch screen display, keyboard/mouse, joystick, buttons, etc., for enabling a user to select options shown on the monitor 108. The processing system 106, the monitor 108, the input device, and/or combinations thereof may be referenced as a controller of the system 100. The controller may communicate with device 102, PIM 104, processing system 106, monitor 108, input devices, and/or other components of system 100.

In some embodiments, the intravascular device 102 includes some features similar to conventional solid state IVUS catheters, such as available from Volcano corporationCatheters and catheters disclosed in US patent US 7846101, which is incorporated herein by reference in its entirety. For example, the intravascular device 102 can include a scanner assembly 110 near a distal end of the intravascular device 102 and a transmission beam 112 extending along a longitudinal body of the intravascular device 102. The cable or transmission harness 112 may include a plurality of conductors, including one, two, three, four, five, six, seven, or more conductors.

The transmission harness 112 terminates in a PIM connector 114 at the proximal end of the intravascular device 102. The PIM connector 114 electrically couples the transmission harness 112 to the PIM 104 and physically couples the intravascular device 102 to the PIM 104. In an embodiment, the intravascular device 102 further includes a guidewire exit port 116. Thus, in some examples, the intravascular device 102 is a rapid exchange catheter. The guidewire exit port 116 allows insertion of a guidewire 118 toward the distal end for guiding the intravascular device 102 through the lumen 120.

The monitor 108 may be a display device, such as a computer monitor or other type of screen. The monitor 108 may be used to display selectable prompts, instructions and visualizations of imaging data to a user. In some embodiments, the monitor 108 may be used to provide a procedure-specific workflow to a user to complete an intravascular imaging procedure. The workflow may include performing a pre-stent planning to determine the status of the lumen and the potential of the stent, and examining the stent that has been positioned in the lumen. The workflow may be presented to the user as any of the displays or visualizations shown in fig. 2-9.

Fig. 2 illustrates an exemplary display 200 showing a prompt 202 in accordance with aspects of the present disclosure. In some embodiments, the display 200 is displayed on the monitor 108 as shown in fig. 1. In other embodiments, display 200 is displayed on a screen of another device, such as PIM 104. The display 200 may be generated by a controller of the intravascular imaging system 100. In some embodiments, display 200 is configured to display prompts and instructions, as well as other data, to an operator. The display 200 may be used to show a complete end-to-end workflow for intravascular procedures. The workflow may include a number of prompts and instructions that may guide the operator through the flow. This may simplify the steps of the flow and help avoid operator error.

The prompts and instructions may be displayed on the display 200 as selectable options so that the operator may interact with the display 200 to select the options. The operator's selection may alter the display 200 so that information corresponding to the selected option is shown. In the example of fig. 1, selectable prompt 202 is displayed on display 200. The prompt includes two selectable options: option 204 corresponds to stent pre-operative planning and option 206 corresponds to stent post-operative examination. The operator may select one of the options 204, 206 that may move the workflow forward, causing the other screen (such as the prompt 302 shown in fig. 3) to be displayed. The options 204, 206 may include a visual representation of the type of flow. For example, option 204 may include a depiction of vasculature within the heart, and option 206 may include a depiction of a stent. In some embodiments, selection of an option 204, 206 may include a change in the visual depiction of the option 204, 206. For example, if the stent pre-operative planning option 204 is selected, the option 204 may appear shaded or gray in the future display of the display 200. This may help indicate that the option 204 has been previously selected by the operator. Other types of feedback may be used to indicate selection of an option. For example, the selectable options 204, 206 may display a blinking region, a highlight region, an alteration region, a shade, an alteration transparency, and other visual indicators.

Option 204 may provide a workflow that may include performing an intravascular procedure (such as a pullback operation) and viewing a pre-stent planning of the results. Option 204 may be used to identify regions within lumen 120 that may benefit from placement of a stent. Option 206 may provide a workflow that may include performing an intravascular procedure (such as a pullback operation) and a post-stent inspection to see the results of the region within lumen 120 where the stent has been previously placed. This option 206 may be used to observe the placement and effectiveness of the stent.

Fig. 3 illustrates an exemplary display 200 showing a prompt 302 in accordance with aspects of the present disclosure. The color, shading, texture, and other graphical properties of the display 200 may be selected to highlight particular features. In some embodiments, the prompt 302 may be displayed after any of the options 204, 206 are selected. In other embodiments, the prompt 302 may be displayed only after the stent pre-operative planning option 204 is selected. The prompt 302 may prompt the operator to select a target vessel. In the example of fig. 3, selecting a target vessel includes selecting a region on the visualization 304, including an artery in the heart. The selectable regions may include the Right Coronary Artery (RCA), the left anterior descending branch (LAD), and the left circumflex branch (LCX). The selectable regions may also include various regions of the artery, as well as other vessels and lumens within other portions of the patient's anatomy. The appearance of the visualization 304 may be altered when one of the regions is selected by the operator. For example, the selected artery may be outlined, highlighted, or colored with a different color. In some embodiments, the selected artery is outlined, shaded, textured, or otherwise highlighted in a contrasting color (e.g., blue, red, or another color).

Fig. 4 illustrates an exemplary display 200 showing a prompt 402 in accordance with aspects of the present disclosure. The prompt 402 may be displayed after the operator has made a selection of the prompt 302 shown in fig. 3. In the example of fig. 4, the LAD artery has been selected by the operator. Prompt 402 shows a summary image of the LAD along with instructions 403 to perform a pull-back procedure from the most distal point on the LAD to the mouth. These instructions 403 may refer to a pullback procedure or other motion of the device 102 within the selected vessel or lumen 120. The instructions 403 may instruct the operator to perform any type of movement of the device 102 within the selected target vessel. For example, given a distance along a selected target vessel, the instructions 403 may instruct the operator to push the device 102. A visualization 404 corresponding to the instructions 403 may also be displayed on the display 200. In the example of fig. 4, the visualization 404 includes a line 406 with an arrow showing the direction in which the pullback procedure should be performed. The visualization 404 may include visual effects, such as changing colors or animations. For example, the arrows of visualization 404 may move in the direction specified by instructions 403. The instructions 403 and visualization 404 may vary depending on the previously selected options. For example, if the operator selects RCA as the target vessel, a visualization 404 of RCA will be highlighted and a corresponding visualization will be displayed showing the procedure outlined by the instructions 403.

In some embodiments, the instructions 403 of the display 200 may vary depending on which option 204, 206 is selected from the prompts 202 shown in FIG. 2. For example, if the post-stent inspection option 206 is selected, the instructions may read "please perform a pull back from a distal point of the stent to a proximal point of the stent". Other instructions may also be included to guide the operator in performing the imaging procedure and acquiring imaging data related to the selected target vessel and/or stent.

Fig. 5 illustrates an exemplary display 200 showing a prompt 502 in accordance with aspects of the present disclosure. The prompt 502 may be displayed after the operator has made a selection of the prompt 402 shown in fig. 4. In the example of fig. 5, the LAD artery has been selected by the operator. The prompt 502 may be accompanied by a visualization 504. In some embodiments, the visualization 504 shows imaging data from the device 102 as the device 102 moves through the selected target vessel. The imaging data may be used as a reference for the operator. In particular, the imaging data shown in the visualization 504 may help the operator know where to start the procedure. In the example of fig. 5, the imaging data may show when the device 102 is positioned at the distal end of the LAD artery such that a pullback operation may be performed. The imaging data may also show other reference data, such as regions of interest along the lumen 120, branches of the lumen 120, problem areas within the lumen 120, or other features. In some embodiments, when the device 102 is placed at the location specified by the instructions (e.g., at the distal portion of the artery), the operator may select the record button 508 to begin recording of the procedure. The display may also include an option 506 to save a particular frame of imaging data before or during the procedure.

Fig. 6 illustrates an example visualization 310 in accordance with aspects of the present disclosure. The visualization 310 may be displayed on the monitor 108. The visualization 310 may present imaging data acquired by the device 102 during an intravascular procedure. In some embodiments, intravascular flow is summarized in the instructions shown in fig. 3-5. In some embodiments, the visualization 310 includes imaging data corresponding to the lumen 120, such as a selected target vessel. The visualization 310 may include a first view 604 and a second view 610 of the lumen 120. In some embodiments, the first and second views 604, 610 may be oriented 90 degrees apart. In the example of fig. 6, a first view 604 shows imaging data corresponding to a view of the lumen 120 straight down (otherwise discussed as a "longitudinal view"), and a second view 610 shows imaging data corresponding to a transverse view of the lumen 120. In other embodiments, other views may also be shown. For example, in fig. 7A-7C, three different views are shown, including a third view 704 showing a three-dimensional cross-sectional view of the lumen 120. The views 604, 610 may include corresponding imaging data.

In some embodiments, visualization 310 may include selected frames of imaging data received by device 102. For example, textbox 611 illustrates that visualization 310 corresponds to frame 1556 in the example of fig. 6. The operator may be able to select any frame from the imaging data received by the device 102. This may allow the operator to focus on a particular region of interest in the lumen 120.

In some embodiments, the measurements are performed automatically on the imaging data with a controller of the intravascular imaging system 100 when the imaging data is acquired by the device 102. In the example of fig. 6, measurements corresponding to the vessel boundary 608 and the Minimum Lumen Area (MLA)606 are displayed on the first view 604. The measurements may also include the diameter of the blood vessel, the center of the blood vessel, the thickness of the blood vessel boundary 608, and other measurements performed automatically by the controller. These measurements may also be shown on other views. For example, the marker 614 is placed at the MLA in the second view 610 corresponding to the MLA 606 in the first view 604. This may help the operator visualize the diameter of the vessel boundary along the lumen 120. The measurement results may be displayed in a numerical format on the visualization 310 at block 612.

Particular portions and views of the visualization 300 can be viewed by the operator by selecting options 620, 622, and 624. In some embodiments, option 620 corresponds to visualization 310 shown in fig. 6, option 622 corresponds to visualization 320 shown in fig. 8, and option 624 corresponds to visualization 330 shown in fig. 9. The operator may select option 620 to view a longitudinal view of the lumen 120, option 622 to view a view of the lesion in the lumen 120, and option 624 to view the stent and surrounding portions of the lumen 120. In some embodiments, the front or first view 604 of each option 620, 622, 624 is accompanied by a lateral view 610 of the lumen 120, as shown in fig. 6, 8, and 9.

Fig. 7A-7C illustrate an exemplary display 700 with various views showing imaging data, in accordance with aspects of the present disclosure. The display 700 may be displayed on the monitor 108. FIG. 7A shows a display 700 with three different views 702, 704, 706 of imaging data. In some embodiments, view 702 is a longitudinal view of lumen 120, view 704 is a three-dimensional cross-section of lumen 120, and lumen 706 is a transverse view of lumen 120. The view 702 may include visualizations of boundaries 710, 712, 714, 716 of aspects of the lumen. For example, boundary 710 may represent a vessel boundary, boundary 712 may represent an MLA of a portion of lumen 120, boundary 714 may represent a central region of lumen 120, and boundary 716 may represent a three-dimensional vessel boundary. Further, planes 718 and 719 may represent planes along which view 702 is viewed. The boundaries 710, 712, 714, 716 in one view may correspond to the boundaries 710, 712, 714, 716 in the other views 702, 704, 706 of the display 700. The presentation of the different views may assist the operator in visualizing the size and shape of the portion of the lumen 120.

Fig. 7B illustrates an exemplary display 700 having functionality that allows an operator to edit one or more of the visualizations of the boundaries 710, 712, 714, 716. In the example of fig. 7B, the operator may use tool 720 to select the boundary to be moved (in this case, boundary 710). The selected boundary may appear as a dashed line. The boundary may move in any direction. In the example of fig. 7B, arrow 722 shows the direction in which the boundary is moved (i.e., in an outward direction). The corresponding movement of the boundary is also shown in the views 702, 706 along with arrow 722 to show the direction of movement. The operator may move the boundaries 710, 712, 714, 716 to correct errors in the imaging data or to visualize potential results of the procedure (such as inserting a stent in the lumen 120).

FIG. 7C shows exemplary display 700 after boundary 710 has moved to a new location at boundary 730. As discussed above, the views 702, 704, 706 show the corresponding boundaries 730, 734 that an operator may view together to better understand the shape of the portion of the lumen 120.

Fig. 8 illustrates an example visualization 320 showing a lesion view in accordance with aspects of the present disclosure. In some embodiments, the visualization 320 corresponds to the stent pre-operative planning option 204 as shown in fig. 2. In some embodiments, the visualization 320 may be used to recommend placement and size of the stent to address the lesion. These recommendations may be made automatically by the system 100 based on the imaging data received by the device 102. In particular, the visualization 320 may be used to visualize the portion of the lumen 120 having the potential "landing zone" 834 for the stent. In some embodiments, the landing zone 834 is a region of interest within the lumen 120 of the MLA that includes the portion of the lumen 120 as marked by the marker 614. Landing zone 834 may be outlined in view 610 to illustrate potential placement of a stent within landing zone 834. The distal end markers 830 and proximal end markers 832 of the landing zone 834 may define the distal and proximal extent of the potential stent. The distal end marker 830 and the proximal end marker 832 may be accompanied by numerical data 820, 822 illustrating the average diameter and plaque burden of the lumen 120 at these locations. In some embodiments, the visualization may also be a depiction of plaque burden 852 along lumen 120. In some embodiments, the depiction of plaque burden 852 is measured automatically based on imaging data from device 102. The visualization 320 may also include a depiction of the luminal region 850. As illustrated in fig. 8, a marker 614 for MLA may be placed where plaque burden is greatest and the area of the lumen is smallest.

In some embodiments, the visualization 320 includes a recommended stent diameter as shown in text box 812. The diameter may be based on the diameter of lumen 102 as measured by system 100.

Fig. 9 illustrates an exemplary visualization 330 showing a stent inspection view in accordance with aspects of the present disclosure. In some embodiments, the visualization 330 is shown after the operator has selected the stent exam option 204 and has navigated through subsequent workflow steps. Visualization 330 may display imaging data collected from device 102 during motion within lumen 120 in which a stent has been placed (such as a pullback procedure), as well as imaging data of periodic regions of the lumen.

The measurements and/or metrics corresponding to the imaging data may be performed automatically by the intravascular imaging system and displayed by the visualization 330. For example, the intravascular imaging system 100 may be used to perform length measurements such as minimum, maximum, average, and average length of features in the imaging data. The effective diameter of the feature may also be measured. Area measurements of features such as lumens, vessels, plaque, and thrombus may be performed by the intravascular imaging system 100. The measurements may include plaque burden, percent stenosis, percent difference, diameter stenosis, percent diameter stenosis, lumen gain, and lumen gain percent. In addition, characteristics of the stent may also be measured by the intravascular imaging system 100, including overall stent area, minimum stent area, average stent area, stent apposition, expansion, ectopy, and stent score. Visualization 330 may include numerical values of one or more of these measurements or other graphical representations (e.g., shading, coloring, etc.), including graphical representations that are superimposed on or displayed/spaced apart from tomographic, longitudinal, and/or angiographic images of the vessel.

In some embodiments, the shape and size of the lumen boundary 904 may be measured and displayed, as well as the boundary of the stent 906. As in fig. 6 and 8, the boundary may be visualized in the first view 604 as well as the second view 610. The visualization 330 may also include a measurement of the length of the stent. For example, the visualization 330 may include distal reference markers 930 and may include a depiction 934 of a stent. The average diameter and plaque burden at the distal reference marker may be shown in text box 916. The Minimum Stent Area (MSA) may also be automatically measured and displayed in text box 912 and with MSA flag 914.

In some embodiments, the visualization 330 may be used to determine the effectiveness of the stent. For example, the visualization 330 may include measurements and depictions of any ectopy of the stent. Ectopic regions 908, 936 may be shown in both the first view 604 and the second view 610 so that the operator may better visualize the ectopy. The ectopic areas 908, 936 may have a different color (such as red) than the other imaging data to highlight the feature. In some embodiments, the ectopic regions 908, 936 are measured automatically using imaging data collected by the device 102 during the stent pull-back procedure. The visualization 330 may also include an extension score 910. In the example of fig. 9, the extension score is 80%. This may indicate that the stent is almost expanded to contact the lumen 120, but ectopic. In some embodiments, the expansion score may vary from 0% (where the scaffold has not yet extended within the scaffold) to 100% (where the scaffold is fully expanded and ectopic is present). The expansion score 910 may be automatically determined by a controller of the system 100 by comparing measurements of the boundaries of the stent 906 and the boundaries of the lumen. In some embodiments, the expansion score 910 is also based on plaque burden and luminal area within the vessel.

Fig. 10 is a flow chart of a method 1000 of providing a guided workflow for an intravascular imaging procedure to a user. In some embodiments, the steps of method 1000 may be performed by intravascular imaging system 100 and associated components as shown in fig. 1. It should be understood that the steps of method 1000 may be performed in a different order than shown in fig. 10, that additional steps may be provided before, during, and after the steps, and/or that in other embodiments, some of the described steps may be replaced or eliminated.

At step 1002, the method 1000 may include providing a guided workflow to a user. The guided workflow may be provided as a series of prompts, instructions, and visualizations displayed on a display device, such as monitor 108 shown in fig. 1. Guided workflows may help a user to easily and accurately perform each of the steps of an intravascular imaging procedure. The guided workflow may present different options based on the user's selection and may include a check of previous steps to ensure that all steps of the flow have been performed.

At step 1004, the method may include providing selectable options for pre-stent planning or post-stent examination. The selectable options may be provided on a display, such as display 200 shown in FIG. 2. Selectable options for pre-stent planning may include performing an intravascular imaging procedure to visualize the vessel or lumen prior to inserting the stent. An alternative option for post-stent inspection may include performing an intravascular imaging procedure to inspect a stent that has been inserted in a vessel or lumen. Each selectable option may include a number of subsequent steps, as discussed below.

At step 1006, method 1000 may include providing an option to select a target vessel. This option may be presented visually, such as presenting various blood vessels on a diagram. In some embodiments, the target vessel is an artery within the heart, such as RCA, LAD, and LCX. In other embodiments, the target vessel is another lumen within the body. This step 1006 may include providing feedback to the user, such as indicating which vessel has been selected. The feedback may include highlighting, coloring, shading, or otherwise indicating the blood vessel that has been selected.

At step 1008, the method 1000 may include providing a prompt to perform an operation within the selected target vessel. In some embodiments, the operation includes moving an intravascular device within the vessel. For example, the operation may be a pull-back operation. In other embodiments, the operation may be an operation to push the intravascular device through a portion of the lumen. The prompt may be presented in a textual format and may include a visualization of the operation.

At step 1010, the method 1000 may include providing a prompt to navigate the intravascular device to a starting point in the selected target vessel and activate a sensor in the intravascular device. The prompt may be presented with text and an image showing where the user should place the intravascular device. In some embodiments, the prompting of step 1010 is dependent on the option selected at step 1004. For example, if the user selects the stent pre-operative planning option at step 1004, the prompt at step 1010 may prompt the user to navigate the intravascular device from the distal-most point of the target vessel to the ostium. If the user selects the stent post-operative inspection option at step 1004, the prompt at step 1010 may prompt the user to navigate the intravascular device from the distal end of the stent to the proximal end of the stent.

At step 1012, the method 1000 may include receiving imaging data from an intravascular device. The imaging data may assist the user in accurately navigating the intravascular device according to the prompts of step 1010. For example, if the prompt of step 1010 guides the user to navigate the intravascular device from the distal end of the stent to the proximal end of the stent, the imaging data may show imaging data from the intravascular device as it moves to the distal end of the stent. In some embodiments, the imaging data may include IVUS data showing tissue layers of the interior of a blood vessel. In other embodiments, the imaging data includes data from another modality (such as OCT). Thus, the imaging data may help the user accurately perform the operations outlined in the prompt.

At step 1014, the method 1000 may include displaying imaging data as the intravascular device moves during operation. The imaging data may assist the user in accurately performing the operation.

At step 1016, the method 1000 may include identifying a region of interest using the imaging data. In some embodiments, the region of interest is identified based on imaging data, such as boundary measurements, luminal area, plaque burden within the lumen, and the like. The region of interest may comprise an MLA or MSA as shown in fig. 6, 8 and 9. In some embodiments, the region of interest includes a landing zone for stent placement or a stent that has been positioned in a lumen. The region of interest may be colored, highlighted, shaded, or otherwise indicated as a region of interest on the display of the imaging data. In some embodiments, measurements of the distal and proximal ends of the region of interest and the size and position of the region of interest are shown.

At step 1018, the method 1000 may include displaying a vascular measurement based on the imaging data corresponding to the region of interest. In some embodiments, vessel measurements such as vessel boundaries, stent boundaries, MLA, MSA, luminal area, plaque burden, and other measurements are displayed on a display. These measurements may be shown graphically (e.g., by colored lines or areas) as well as locally (e.g., in a text box). The vessel measurements may also include recommendations (such as a recommended size and location of the stent) and scores (such as a stent expansion score). The vessel measurements may allow a user to quickly identify problem areas and possible solutions within the lumen.

Those skilled in the art will recognize that the apparatus, systems, and methods described above may be modified in various ways. Therefore, those of ordinary skill in the art will appreciate that the embodiments encompassed by the present disclosure are not limited to the specific exemplary embodiments described above. In this regard, while illustrative embodiments have been shown and described, a wide variety of modifications, changes, and substitutions are contemplated in the foregoing disclosure. It will be appreciated 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 disclosure.