Systems and methods of combined imaging

By using cardiovascular system time-series parameters and signals combined with intravascular imaging technology in the diagnosis and treatment of coronary artery disease, the registration of fluorescence fluoroscopy images and angiography images is achieved, solving the problem of registration between fluorescence fluoroscopy images and angiography images, improving surgical efficiency and reducing the use of contrast solutions.

CN122423904APending Publication Date: 2026-07-21LIGHTLAB IMAGING LLC
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
LIGHTLAB IMAGING LLC
Filing Date
2020-09-18
Publication Date
2026-07-21

AI Technical Summary

Technical Problem

In the diagnosis and treatment of coronary artery disease, existing technologies have difficulty effectively registering fluorescence fluoroscopy images with angiography images, which requires doctors to frequently switch screens and process multiple data sources during surgery, increasing the difficulty of operation and the amount of angiography solution used.

Method used

By using cardiovascular system timing parameters and signals (such as ECG and AO pressure signals) to identify corresponding frames of the cardiac cycle, and combining them with intravascular imaging techniques (such as OCT and IVUS), registration of fluorescence fluoroscopy images and angiography images can be achieved, reducing dependence on contrast solutions.

Benefits of technology

This improved the efficiency of the procedure, reduced the use of contrast solutions, ensured the accuracy of stent placement, and reduced patient radiation exposure.

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Abstract

Aspects of the present disclosure relate to the combination and display of live and non-live patient images. Described features include: collecting angiogram image data; and correlating angiogram image frames to time-varying data related to a patient's cardiac cycle. This time-varying data can then be compared to live cardiac cycle data of the patient, such that the collected angiogram image frames can be interleaved within a display of live fluoroscopy images of the patient.
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Description

[0001] This application is a divisional application of the invention patent application filed on September 18, 2020, with application number 202080076285.0 and entitled "System and Method for Combined Imaging". Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Patent Application No. 62 / 902,948, filed on September 19, 2019, the disclosure of which is hereby incorporated herein by reference. Technical Field

[0003] This disclosure generally relates to the field of vascular system imaging and data acquisition systems and methods. In particular, this disclosure relates to methods for providing in-situ X-ray images (e.g., fluoroscopic images) combined with registered angiographic frames. Background Technology

[0004] Coronary artery disease is one of the leading causes of death worldwide. Better capabilities for diagnosing, monitoring, and treating coronary artery disease can be life-saving. This involves healthcare professionals viewing multiple sources of information, including angiographic images and live fluoroscopic images, as part of stent planning or stent delivery. Switching between these two data sources can be exhausting, often requiring personnel to maintain focus on the correlation between images and other data when switching from changing fluoroscopic images to angiography (as part of stent planning and delivery). Therefore, there is a need for systems, methods, and devices that provide useful diagnostic information and improve imaging for planning and cardiovascular surgery.

[0005] This disclosure addresses these and other issues. Summary of the Invention

[0006] Partially, this disclosure relates to systems and methods for registering in-situ fluoroscopy image data with angiographic image data. The method includes: in a first imaging phase, timely collecting a first set of time-varying data corresponding to a cardiac cycle at one or more points, wherein the first imaging phase includes: angiographic imaging of the subject to generate a set of angiographic frames; identifying angiographic frames corresponding to a first sub-set of the time-varying data; in a second imaging phase, timely tracking or collecting a second set of time-varying data corresponding to a cardiac cycle at one or more points, wherein the second imaging phase includes: in-situ fluoroscopy imaging of the subject to generate a set of in-situ fluoroscopy angiographic frames; associating the first set of time-varying data with the second set of time-varying data to identify angiographic frames corresponding to the in-situ fluoroscopy frames; and displaying the first set of one or more in-situ fluoroscopy frames and one or more angiographic frames corresponding to the second set of one or more in-situ fluoroscopy frames.

[0007] Intravascular and peripheral vascular image data from various sources and flows can be combined and interleaved, as disclosed herein. Furthermore, various cardiovascular signals and rhythms can be used to support the registration of two or more imaging modalities and then combine one or two registered imaging modalities with field image data (e.g., fluoroscopy, cine, or other field images for the catheterization lab). One or more devices can display one or more user interfaces and intravascular data or other information derived from such data. Intravascular data can be acquired using IVUS or OCT-based data acquisition systems and probes or other imaging modalities. The method can be implemented using one or more computing devices and memory storage, wherein the computing devices and memory storage receive intravascular data and user input via a graphical user interface (GUI) and include one or more image processing and frame selection software components. The computing device can be a microprocessor, an application-specific integrated circuit (ASIC), or other processor suitable for use in an intravascular imaging system.

[0008] In part, this disclosure relates to systems and methods for evaluating and deploying stents using a combination of in-situ fluoroscopic frames and angiographic frames. The combination of interleaved frames supports arterial resection, stent placement, and balloon-based processing, enhanced by imaging, analysis, and diagnostic systems and the foregoing combination. This disclosure provides systems and methods in which: a first set of object images captured in a first time period and a first set of time-varying data corresponding to the cardiac cycle of the object in the first time period are acquired by one or more processors; subgroups of the first set of object images are associated with subgroups of the first set of time-varying data by the one or more processors; a second set of object images captured in a second time period and a second set of time-varying data corresponding to the cardiac cycle of the object acquired in the second time period are acquired by the one or more processors; the first set of time-varying data is associated with the second set of time-varying data by the one or more processors; one or more image frames corresponding to a subgroup of the second set of time-varying data are identified from the first set of object images by the one or more processors; and the one or more processors provide a display of one or more image frames identified from the first set of object images, interleaved with multiple image frames from the second set of object images.

[0009] According to this disclosure, the first set of object images may be angiographic images, and the second set of object images may be fluorescence fluoroscopy images. Furthermore, the fluorescence fluoroscopy images may be on-site images of the object; the second set of time-varying data may be on-site cardiac cycle data of the object.

[0010] According to another aspect of the disclosed system and method, the first set of time-varying data and the second set of time-varying data may include aortic (AO) pressure values ​​and / or ECG values. Furthermore, the first time period may include: simultaneously performing intravascular imaging of the subject using an intravascular probe (e.g., an OCT or IVUS probe) with one or more opaque markers, wherein the intravascular imaging of the subject generates a set of intravascular image frames. Additionally, the system may be configured to register the intravascular image frames with the first set of subject images. The system may also be configured to display one or more intravascular image frames or a subset thereof corresponding to one or more field angiography frames.

[0011] The disclosed system can also be configured to display to a user one or more image frames identified from the first set of object images, interleaved with multiple image frames from the second set of object images. The interleaving of image frames may include replacing one or more image frames from the second set of object images with one or more image frames from the first set of object images. According to various aspects of this disclosure, each of the one or more image frames from the second set of object images and the one or more image frames from the first set of object images can be captured in a corresponding portion of a patient's cardiac cycle. The system can also be configured to display one or more image frames identified from the first set of object images, interleaved with multiple image frames from the second set of object images, by inserting one or more image frames identified from the first set of object images between image frames from the second set of object images.

[0012] While the present invention relates to different aspects and embodiments, it should be understood that the different aspects and embodiments disclosed herein may be integrated in whole or in part as appropriate. Thus, each embodiment disclosed herein may be incorporated into each aspect to varying degrees as appropriate for a given implementation. Furthermore, various software-based tools for addressing medical imaging problems and other related challenges and problems, along with the foregoing portions, can be used in medical and other applications for displaying information related to stents, blood vessels, and their two-dimensional and three-dimensional views in a non-limiting manner. Other features and advantages of the disclosed embodiments will become apparent from the following description and accompanying drawings.

[0013] While this disclosure relates to various aspects and embodiments and other features described and illustrated herein, it should be understood that each of the foregoing contents disclosed herein may be integrated, in whole or in part, as appropriate. Thus, each embodiment disclosed herein may be incorporated to varying degrees into each scheme as appropriate for a given implementation. Furthermore, the various stent expansion diagnostic tools described herein can be used with various imaging modalities.

[0014] Other features and advantages of the disclosed embodiments will become apparent from the following description and the accompanying drawings. Attached Figure Description

[0015] Figure 1A A schematic diagram of an imaging and data collection system according to various aspects of this disclosure is shown.

[0016] Figure 1B Exemplary operational configurations are shown in the embodiments according to various aspects of this disclosure.

[0017] Figure 2 This diagram illustrates the synchronization of time-varying cardiac cycle data of an object with angiographic images of that object in accordance with various aspects of this disclosure.

[0018] Figure 3 A schematic diagram showing synchronous field data and off-site data in accordance with various aspects of this disclosure is provided.

[0019] Figure 4A and 4B This diagram illustrates the correlation between time-varying cardiac cycle signal data and angiographic images according to various aspects of this disclosure.

[0020] Figure 5 The images show in-situ fluorescence fluoroscopic images and in-situ time-varying cardiac cycle signal data of the objects according to various aspects of this disclosure.

[0021] Figure 6 A schematic diagram illustrating the real-time correlation between off-site and on-site data in accordance with various aspects of this disclosure.

[0022] Figure 7 This demonstrates how, in accordance with various aspects of this disclosure, on-site fluorescence fluoroscopy images are replaced with off-site angiography images.

[0023] Figure 8 This displays a field fluorescent perspective image superimposed with markers, representing various aspects of this disclosure.

[0024] Figure 9 A flowchart illustrating the methods according to various aspects of this disclosure is shown. Detailed Implementation

[0025] This disclosure relates in part to systems and methods for identifying angiographic frames corresponding to different parts of the cardiac cycle using cardiovascular system timing parameters and / or signals (e.g., ECG and pressure signals, such as aortic pressure signals)). Dipstick notches and other timing markers (e.g., markers for identifying systolic and diastolic phases) can be used. Furthermore, the disclosed systems and methods can identify angiographic frames corresponding to a current fluoroscopic image based on real-time correlation with such signals and / or timing parameters.

[0026] In one embodiment, for each in-situ fluoroscopy frame, the corresponding angiography frame is identified based on signal or temporal parameter association (e.g., via ECG association). Further, in some embodiments, intravascular probe markers (e.g., radio-opaque markers) are used and associated with angiography as part of the intravascular imaging process (e.g., via optical coherence tomography (OCT)); or the intravascular imaging is intravascular ultrasound (IVUS) imaging. In this way, intravascular imaging (e.g., OCT or IVUS) facilitates angiography association.

[0027] OCT is a catheter-based imaging method that uses light to penetrate the walls of coronary arteries and generate images for research. Utilizing coherent light, interferometry, and micro-optics, OCT can provide in vivo tomographic video rates within diseased vessels at micrometer-level resolution. The high-resolution viewing of subsurface structures using fiber optic probes makes OCT particularly useful for minimally invasive imaging of internal tissues and organs. This feasible level of detail in OCT allows users to diagnose and monitor the progression of coronary artery disease. Another form of intravascular imaging is intravascular ultrasound (IVUS), which uses high-frequency sound waves to form images within the blood vessels.

[0028] OCT / IVUS imaging of parts of a patient's body provides doctors and others with a useful diagnostic tool. For example, intravascular OCT / IVUS imaging of the coronary arteries can reveal the location of narrowing or stenosis. This information helps cardiologists choose between invasive coronary artery bypass grafting and catheter-based, less invasive procedures such as angioplasty or stent delivery. While stent delivery is a common option, it also carries its own associated risks.

[0029] In one embodiment, angiography and in-situ fluoroscopy co-registration can be combined with the foregoing to allow intravascular markers and intravascular image data or parameters to be overlaid or registered with in-situ fluoroscopy. Due to the registration between these three sets of image data, stent detection, stent expansion, side branches, and other image data detected based on the collected intravascular data sets can be associated with or displayed relative to the in-situ fluoroscopy and angiography images.

[0030] These various sets of data (angiography, intravascular imaging (OCT / IVUS), and in-situ fluoroscopy) can be combined, interleaved, used, juxtaposed, or integrated in various ways to present the combined or registered data to the end user. Further, in various embodiments, this disclosure relates to methods for reducing the amount of contrast solution used by interleaving angiography frames with in-situ fluoroscopy, thereby using fewer angiography frames and thus requiring less contrast solution.

[0031] The use of angiographic images, fluorescence fluoroscopy data, intravascular data, and other imaging modalities supporting cardiovascular diagnosis and stenosis management is of great value if it can be performed quickly and in an end-user-friendly manner. Addressing the various competing barriers to these objectives presents significant technical challenges. Registration data and signals (e.g., AO, EKG, systolic transition, diastolic transition, etc.) and the generation of various interleaved, static, combined, and fused data sets (including data streams with in-situ subframes and stored, historical, or otherwise off-situ subframes) can be used in various embodiments.

[0032] In part, this disclosure relates to systems and methods for fusing angiographic registration images and / or data with in-situ fluoroscopy. Further, this disclosure relates to systems and methods for combining angiographic registration (co-reg or registration or reg) information with one or more in-situ fluoroscopy feeds.

[0033] Figure 1A and 1B The diagram illustrates an imaging and data acquisition system according to an exemplary embodiment of the present disclosure, suitable for imaging arteries, stents, and other cardiovascular system components, and synchronizing field data with data acquired during registration of angiographic and intravascular data. In one embodiment, fluorescence fluoroscopy feeds from a C-arm or other, for example... Figure 1A and 1B The fluorescence fluoroscopic imaging apparatus or system shown is obtained. In various embodiments, the disclosed imaging systems, devices, and subsystems are suitable for use in a catheterization laboratory. This will provide physicians with direct guidance in attempting to place stents and devices into their pre-planned locations within the OCT / IVUS angiography registration system.

[0034] The systems and methods disclosed in this paper address a variety of technical challenges that physicians and other catheterization lab personnel must address during various procedures. For example, it is extremely strenuous for a physician to plan a stent on one screen (e.g., an angiography screen on a monitor 127, 82, or other monitor), simultaneously pushing the stent forward and looking at another screen 133 (which may be distant and transmits live fluoroscopic data) while mentally synthesizing this information. This stress and mental strain are further exacerbated if other data (e.g., intravascular data or pressure data) are being presented on different screens. This requires the user to mentally plan where the stent will go and be guided to the desired geometrical stopping area while using the displayed arterial topography and pushing the stent with an opaque guidewire. This is performed during the periodic ejection or spraying of contrast solution to visualize the artery. Dispensing dark contrast solution when pushing the dark object corresponding to the stent is difficult. Visualizing the vessel, pushing the stent to the stopping area, and pushing the contrast solution to have a holistic view of the vessel are all part of guiding the stent to the target area (e.g., proximal to a side branch). In addition to the above, it is also difficult to continuously turn one's head back and forth between various screens (where angiography, fluorescence fluoroscopy, and intravascular images may be far apart).

[0035] Furthermore, the arteries being traversed have undulating side branches moving in three dimensions, and the challenge lies in maintaining the trajectory of the arterial reference frame without losing the positional trajectory. Consequently, loss of positional trajectory can lead to misalignment of the topography relative to the target placement area. This can be compensated for by continuing to spray / push the angiographic solution. Nevertheless, however, excessive use of angiographic solution is not recommended for different patient types based on varying conditions (e.g., those with kidney problems). More complex stent planning, such as requiring two stents or needing to re-inflate under-expanded stents, further complicates matters. Therefore, registration systems offer several advantages.

[0036] If various data collection and diagnostic systems (e.g., angiography systems using OCT, IVUS, or other intravascular imaging systems) use imaging probes with radiopaque markers to track a given probe, angiography data can be registered with intravascular data. These data sets can be registered, correlated, and cross-linked to in-situ fluoroscopy fees using pressure signals or other pressure signals used to monitor aortic pressure, EKG signals, dicrotic notch signals and locations, and other time-series signals. A dongle or other data transmitter (e.g., Figure 2(As shown) Pressure data from a given data collection device (e.g., an imaging system or a pressure sensing system) can be transmitted. A pressure transducer from the object can wirelessly or via a wired connection transmit such pressure data to an intravascular imaging system to synchronize angiographic data and such pressure data, and store this data for use in the catheterization lab. The aforementioned processing of pressure data synchronized with angiographic data can also be achieved using other pressure signals, EKG signals, dicrotic notch signals and positions, other timing signals, intravascular data frames, pressure data, flow data, and other data collected in the catheterization lab. The collected data can be displayed on in-situ fluoroscopic data.

[0037] In one embodiment, approximately K frames per second of angiographic data are divided into K / n slices for a given curve (e.g., an AO pressure curve, or an ECG curve). In one embodiment, K is approximately 15. For a given angiographic frame or OCT / IVUS frame, the angiographic data or OCT / IVUS data can be registered relative to a given AO curve, ECG curve, systolic curve, diastolic curve, or other time-varying function suitable for registration, consisting of bars, segments, slices, or time slices. In one embodiment, a given time-varying curve / function (e.g., an AO curve or ECG curve) is divided into K (e.g., 15) bars. As a result, the registration system can track or otherwise depict which frame corresponds to the first part of the cardiac cycle, which frame corresponds to the identified dicrotic notch, which segment of the frame corresponds to the middle of diastole, and so on. Thus, a given curve or curve is divided into individual bars, subgroups, slices, etc., and frames are depicted or associated with angiographic and / or intravascular data and / or fluoroscopy data. In one embodiment, AO pressure near the aortic notch is preferred due to its greater stability.

[0038] Each cardiac cycle lasts approximately 1 second. Further, a typical angiography imaging system operates at approximately 15 frames per second. In one embodiment, approximately 15 frames exist per cardiac cycle. In another embodiment, approximately 30 frames exist per cardiac cycle. The system includes a component that samples K frames per cardiac cycle. Furthermore, the sampled data can be smoothed or filtered.

[0039] In one embodiment, for a given catheterization lab data acquisition system and method embodiment, there is a live fluoroscopic feed. AO pressure data or other timing or signal data (e.g., ECG) is used to determine which portion of the cardiac cycle corresponds to a given AO pressure data. This may correspond to the systolic and diastolic phases within an identified cardiac cycle or other trackable timeframe relative to the cardiac cycle. Once the AO pressure data or other timing data or signal is depicted against the cardiac cycle or other clock or timing subsystem, the data of interest is registered with pre-calculated angiographic data (which has been fused with OCT / IVUS markers). Typically, the system and method identify which portion of the cardiac cycle is tracked or corresponds to a specific image data frame or other parameter of interest.

[0040] The foregoing is useful when registering live fluoroscopy data. In particular, real-time correlation effectively identifies portions of the cardiac cycle that can be tracked over time relative to AO pressure data or other data or signals (e.g., ECG data used for fluoroscopy). As a result, this facilitates the selection of arbitrary frames from a set of angiographic image frames and the replacement of such angiographic frames with live fluoroscopy frames. Frame depictions or replacements can be used, or diagrams in schematic representations can be used, etc. In one embodiment, angiographic frames are replaced with fluoroscopy frames using transformations or other methods. Various interleaving techniques can be used. This frame replacement supports the use of a library of angiographic images previously generated by angiography.

[0041] If the image location is known in real time via fluoroscopy tailored to the cardiac cycle, the previously generated library of angiographic frames can be interleaved with the live frames, and vice versa. This reduces the amount of contrast solution used because new angiographic frames do not need to be of the same quality. The interleaving of live fluoroscopy feed with the library of angiographic frames previously acquired from different sites can be performed automatically.

[0042] There are several benefits to these registrations based on cardiac cycle and other temporal correlations. For example, stent deployment can be achieved by effectively simulating angiographic flushing (assuming access to a frame library in which flushing was previously performed in captured angiographic frames) or by using intravascular data (e.g., OCT or IVUS image data). In this way, the systems and methods facilitate reduced exposure to angiographic solution and can avoid or at least significantly reduce the need for angiographic solution by using intravascular image data. In various embodiments, the angle / position of the fluorescence fluoroscopic image can be varied to further reduce the need for angiographic solution.

[0043] In one embodiment, during intravascular pull-back, the image frame is dark under angiography. Separate pull-back periods exist, which can be tracked and indexed for angiographic frames and registered for AO pressure data, ECG data, dicrotic notch, or other time-series data. In one embodiment, each subsequent frame interleaving can be performed using AO data or other time-series data. One or more displays can be used to display in-situ fluoroscopy data, wherein frames are pulled from the in-situ feed using a frame grabber and interleaved with angiographic frames or combined with intravascular data. Effectively, in-situ fluoroscopy data can be displayed relative to off-situ angiographic data (e.g., from a library of angiographic frames) and then replaced. Intravascular imaging markers (e.g., OCT / IVUS markers) and other information can be combined, overlaid, or otherwise used with the in-situ fluoroscopy feed. This fusion or combination of various types of image data with in-situ fluoroscopy data can be used to support various effects, such as accurately knowing the location of the stent placement area.

[0044] The techniques and other techniques disclosed herein can also be used to guide arterial resection balloons, visualize calcium, and other detected elements using intravascular data from in-situ fluoroscopy data streams. Guidewires, stents, side branches, lumens, MLAs, lumen diameter, lumen profile, area, cross-section, volume, misalignment, stent underexpansion, side branch occlusion, and other information detectable using intravascular data can be registered with in-situ fluoroscopy using the systems and methods disclosed herein.

[0045] Figure 1A The display system 5 includes various data collection subsystems suitable for collecting data on object 4, detecting features or sensing conditions, or otherwise diagnosing. In one embodiment, the object is placed on a suitable support 19 (e.g., a table, bed, chair, or other suitable support). Typically, object 4 is a person or other animal with a specific area of ​​interest 25.

[0046] Data collection system 5 includes non-invasive imaging systems, such as MRI, X-ray, computed tomography, or other suitable non-invasive imaging techniques. A non-limiting example of such a non-invasive imaging system is shown, illustrating an angiography system 21, suitable for generating cine, for example. Angiography system 21 may include a fluorescence fluoroscopy system. Angiography system 21 is configured to non-invasively image subject 4, thereby generating angiography data frames (typically in the form of image data frames) during a pull-back process using probe 30, such that vessels in region 25 of subject 4 are imaged using angiography with one or more imaging techniques (e.g., OCT or IVUS).

[0047] The angiography system 21 communicates with angiography data storage and image management system 22, which in one embodiment may be implemented as a workstation or server. In one embodiment, data processing associated with the collected angiography signals is performed directly on the detectors of the angiography system 21. Images from the system 20 are stored and managed by the angiography data storage and image management system 22. Other imaging systems disclosed herein may replace or enhance system 21.

[0048] Imaging data and the resulting data (such as vascular imaging) are generated and displayed as part of the user interface to quickly provide diagnostic information. These can take the form of different lumen profiles and ratio values, such as area, diameter, or other geometric values, at corresponding locations along the length of the lumen.

[0049] Figure 1A The system includes various components for imaging one or more arterial and / or cardiovascular system components, wherein one or more of the following are used: CT scan, ultrasound, IVUS, X-ray based imaging, magnetic resonance imaging, optical coherence tomography, infrared-based imaging, laser-based imaging, and other imaging modalities for intravascular and extravascular imaging. In one embodiment, system server 50 and / or workstation 85 control the functionality of system 22. In one embodiment, the entire system 5 generates electromagnetic radiation, such as X-rays. System 22 also receives this radiation after it passes through object 4. Furthermore, data processing system 22 uses signals from angiography system 21 to image one or more regions (including region 25) of object 4.

[0050] Region of interest 25 may be a subgroup of a blood vessel or the surrounding vascular system, such as a specific vessel. This subgroup may be imaged using one of the following imaging methods: OCT, ultrasound (alone or in combination), or other imaging techniques disclosed herein. In one embodiment, this region of interest may include a stent or the area where the stent is to be placed. The stent may be imaged at appropriate times at different sites, such as after deployment and after supplemental stent expansion.

[0051] A catheter-based data collection probe 30 is introduced into the object 4 and placed in the lumen of a specific blood vessel (e.g., a coronary artery). Probes or other devices, including balloons, can also be used to increase the level of stent expansion in response to detection of insufficient stent expansion using one or more imaging modalities.

[0052] Probe 30 can be various types of data acquisition probes, such as OCT probes, FFR probes, IVUS probes, probes combining two or more of the aforementioned features, and other probes suitable for intravascular imaging. In one embodiment, a balloon delivery device is moved along a guidewire for the imaging probe disclosed herein. In one embodiment, probe 30 typically includes a probe tip, one or more radiopaque markers, an optical fiber, and a torque wire. Furthermore, the probe tip includes one or more data acquisition subsystems, such as a beamguide, an acoustic beamguide, a pressure sensing sensor, other transducers or detectors, and combinations thereof.

[0053] For probes including beam guides, fiber 33 optically communicates with the probe having the beam guide. A torque wire defines an aperture in which the fiber is positioned. Figure 1A In the diagram, fiber optic 33 is shown without a torque filament around it. Additionally, probe 30 may include a sheath (not shown) forming part of the catheter, such as a polymer sheath. Fiber optic 33 (in the context of an OCT system application, it is part of the sample arm of an interferometer) is optically coupled to patient interface unit (PIU) 35, as shown.

[0054] The patient interface unit 35 includes a probe connector adapted to receive and optically connect to the end of the probe 30. Typically, the data acquisition probe 30 is disposable. The PIU 35 includes suitable connectors and components based on the type of data acquisition probe used. For example, an OCT and IVUS combined data acquisition probe requires an OCT and IVUS PIU. The PIU 35 typically also includes a motor adapted for retracting the torque wire, sheath, and the optical fiber 33 disposed therein (as part of the retraction process). In addition to retraction, the probe tip is typically rotated via the PIU 35. In this way, the vessels of the object 4 can be imaged longitudinally or via cross-section. The probe 30 can also be used to measure specific parameters, such as fractional flow reserve (FFR) or other pressure measurements.

[0055] PIU 35 is then connected to one or more intravascular data acquisition systems 42. The intravascular data acquisition system 42 may be an OCT system, an IVUS system, other imaging systems, or combinations thereof. For example, in an application environment where probe 30 is an OCT probe, system 42 may include: an interferometer sample arm, an interferometer reference arm, a photodiode, a control system, and a patient interface unit. Similarly, as another example, in an IVUS system application environment, intravascular data acquisition system 42 may include: ultrasound signal generation and processing circuitry, a noise filter, a rotatable connector, a motor, and an interface unit. In one embodiment, data acquisition system 42 and angiography system 21 may have a shared clock or other timing signals configured to synchronize angiography video frame timestamps and OCT image frame timestamps.

[0056] Various extravascular imaging systems (e.g., angiography systems) can image a given region of interest (e.g., stents in various expansion states). Extravascular imaging data can be fused with intravascular imaging data. The outputs of intravascular and extravascular imaging modalities can be displayed to the patient in the catheterization lab using a graphical user interface 127 on various displays 123, such as... Figure 1B As shown in the image.

[0057] Apart from Figure 1A In addition to invasive and non-invasive image data acquisition systems and devices, various other types of data can be collected regarding object region 25 and other parameters of interest to the object. For example, data acquisition probe 30 may include one or more pressure sensors, such as... Figure 2 The pressure wire 232 is shown. The pressure wire can be used with or without an OCT or ultrasound component. Pressure readings can be obtained along a segment of the blood vessel in region 25 of object 4.

[0058] Such readings can be transmitted via a wired or wireless connection. As shown in a fractional flow reserve (FFR) data collection system, a wireless transceiver 48 can be configured to receive pressure readings from probe 30 and transmit them to the system to generate FFR measurements or further locations along the measured vessel. Figure 1A and 1B One or more displays 82, 83, 123 may also be used to display angiography frames, OCT frames, user interfaces for OCT and angiography data, and other control parameters and features of interest.

[0059] like Figure 1A As shown, intravascular image data (e.g., intravascular data frames generated using data collection probe 30) can be routed to data collection and processing system 42 (which is coupled to the probe via PIU 35). Non-invasive image data generated using angiography system 22 can be sent to, stored in, and processed by one or more servers or workstations (e.g., registration server 50, workstation 85). Video frame capture device 55 (e.g., a computer board configured to capture angiography image data from system 22) can be used in various embodiments.

[0060] In one embodiment, server 50 includes one or more registration software modules 67, which are stored in memory 70 and executed by processor 80. Server 50 may include other typical components for a processor-based computing server. Alternatively, additional databases (such as database 90) may be configured to receive generated image data, object parameters, and other generated information, which is transmitted via... Figure 1AOne or more systems, devices, or components shown are transmitted to and received by database 90. While database 90 is shown connected to server 50 when stored in memory at workstation 85, this is merely an exemplary configuration. For example, software module 67 may run on the processor at workstation 85, and database 90 may reside in the memory of server 50. Devices or systems for running various software modules are provided as examples. In various combinations, the hardware and software described herein can be used to acquire image data frames, process such image data, and register such image data.

[0061] As described separately herein, software module 67 may include software (e.g., preprocessing software), transformative, matrix, and other software-based components for processing image data or responding to patient triggers to facilitate the registration of different types of image data or otherwise perform such fusion via other software-based components 67. The module may include: lumen detection using scan-line-based or image-based methods; stent detection using scan-line-based or image-based methods; indicator generation; stent expansion evaluation and assessment; stent placement area detection and indication of deployed stents; angiography and intravascular imaging registration; and other modules that support and are programmed to perform the methods disclosed herein.

[0062] Database 90 may be configured to receive and store angiography image data 92, such as image data generated by angiography system 21 and obtained by frame capture server 50. Database 90 may also be configured to receive and store OCT / IVUS image data 95, such as image data generated by OCT system 42 and obtained by frame capture server 50.

[0063] Furthermore, object 4 may be electrically connected to one or more monitors, such as monitor 49, via one or more electrodes. Monitor 49 may, without limitation, include an electrocardiogram monitor configured to generate data relating to cardiac function and displaying various states of the object (e.g., systole and diastole). Knowing the cardiac phase can be used to assist in tracing the vascular centerline because the geometry of the heart (including the coronary arteries) is approximately the same at a given cardiac phase, even in different cardiac cycles.

[0064] The use or omission of directional arrows in a given diagram is not intended to restrict or require the flow of information. For a given connector, for example... Figure 1A The diagram shows arrows and lines connecting the various elements. Information may flow in one or more directions or only in one direction, as appropriate for a given embodiment. The connections may include various suitable data transmission connections, such as optical, wired, powered, wireless, or electrical connections.

[0065] One or more software modules can be used to process data from angiography systems (e.g., Figure 1A The system 22 shown receives angiography data frames. Various software modules (which may include, without limitation, software, its components, or one or more steps of a software-based or processor-executed method) may be used in the given embodiments of this disclosure.

[0066] Figure 1A and 1B The system is suitable for displaying intravascular and extravascular image data. In particular, the system is advantageous for stent planning and stent expansion assessment, as well as target stent expansion assessment. In one embodiment, the stent expansion threshold can be provided by a diagnostic system (e.g., OCT, IVUS, or other image data collection system), or such a threshold can be adjusted and set by the end user via a user interface. In one embodiment, the stent expansion threshold for identifying areas of insufficient stent expansion ranges from about 80% to about 90%. Thus, if the stent expands to a level of 48% at a first location along its length, it is identified or displayed by a visual cue or identifier, while if the stent expands to the threshold or higher in another area, it is identified by another visual cue or identifier.

[0067] Figure 1B The catheterization lab facility is equipped with imaging and data acquisition systems (e.g.) Figure 1A The system comprises various components for performing OCT, FFR, IVUS, angiography, CT scans, or other types of imaging, measurement, and evaluation on one or more arteries of a patient. Users can interact with the data collection system or otherwise access and display the stored image data via various displays shown. An exemplary user interface is shown, displaying intravascular imaging data and stent expansion data registered with angiographic data. Support member 115 is, for example, an auxiliary track on a table, bed, or other support 120. In one embodiment, support member 115 may be part of support 120, and the controller may be directly attached to support 120.

[0068] In one embodiment, the controller may include any suitable input device and may be used to navigate user interface screens and parameters, such as target stent expansion values ​​and other stent expansion thresholds. The controller may be used to display and navigate a graphical user interface displayed on one or more monitors or displays 123. In one embodiment, the monitor may be mounted to a ceiling-mounted fixture. A graphical user interface 127 may be displayed on a given monitor. The graphical user interface may include intravascular data on stent expansion and registration, such as OCT / IVUS data, angiography data, and fluoroscopic images.

[0069] In one embodiment, the controller has a set of features configured to map to user-available commands and menus as part of a graphical user interface 127. An angiography system or other imaging system 125 disclosed herein may be positioned relative to a support 120 to obtain X-rays of the patient while another data collection process (e.g., an OCT / IVUS process) is in progress. The graphical user interface 127 may display such OCT, angiography, FFR, IVUS, and other data of interest to the user. The controller is configured to control the interface 127 and navigate its menus and image display features presented to the user. Registering angiography data with intravascular imaging supports assessment of stent expansion levels. Furthermore, registering fluorescence fluoroscopy with angiography and intravascular imaging improves stent deployment and facilitates viewing only one monitor during procedures involving the artery (e.g., stent placement, arterial resection, angioplasty, etc.).

[0070] This disclosure describes systems and methods for mapping areas of stent under-expansion and target expansion levels relative to vascular imaging generated using intravascular data, thereby facilitating targeted balloon placement and sizing for the stent. Optical coherence tomography and other imaging modalities can be used to generate various vascular images and perform various image data processing techniques to detect and / or visually image the lumen L, stent struts SS, side branches SB, etc., as shown and described herein.

[0071] These systems, devices, and methods can be implemented when evaluating a subject for the first time using diagnostic methods, such as one or more cardiac imaging modalities. These imaging modalities may include, but are not limited to: OCT, IVUS, computed tomography, MRI, angiography, X-ray, and stress data-based models of cardiac and / or vascular function and status.

[0072] Figure 2 Displaying angiographic data (e.g., angiographic image 210), which is compared with data collected from region 25 of patient 4 (using... Figure 1A and 1BThe system described herein synchronizes time-varying parameters of the patient's cardiac system with data. The collected cardiac data may include ECG data or AO pressure data 220, acquired via the pressure wire 232 of probe 30 and transmitted via wireless transceiver 48 to data collection device 240. AO pressure data 220 is a time-varying parameter that can be synchronized with angiographic data acquired from the patient. For example, by determining the portion of AO pressure data 220 corresponding to the time when angiographic image 210 was captured, angiographic image 210 can be synchronized with that portion of AO data 220. This process can be performed on multiple angiographic images, based on the time when both the angiographic image and AO pressure data 220 were acquired, such that each angiographic image is associated with a specific portion of the patient's AO pressure data 220.

[0073] exist Figure 3 In this process, intravascular (OCT / IVUS) and angiography data 310 were acquired and registered together. This is similar to combining... Figure 2 The aforementioned synchronization, whereby the registered intravascular / angiographic data 310 is synchronized with the AO data 220, associates specific angiographic and OCT / IVUS images with specific portions of the AO data 220. The synchronized intravascular / angiographic data 310 and AO data 220 can be stored in... Figure 1A and 1B Describes one or more storage devices. Furthermore... Figure 1A and 1B The system can collect on-site fluoroscopic images 312 from the patient. These on-site fluoroscopic images 312 can be synchronized with on-site AO data 320. Although AO data is used as an example, the synchronization described herein can be performed on any repeatable time-varying data (including ECG data) obtained during the on-site imaging and initial registration phases. The on-site AO data 320 can then be compared and synchronized with previously acquired AO data 220. Furthermore, the on-site fluoroscopic data 312 can be synchronized or registered with intravascular angiography data 310 based on this comparison. In this way, the corresponding fluoroscopic images and angiography images can be identified in combination with specific subgroups of the patient's cardiac cycle.

[0074] In various embodiments, ECG and AO pressure signals are used to identify angiographic frames corresponding to different parts of the cardiac cycle. For example... Figure 4AAs shown, the ECG pulse 424 can be identified in the patient's ECG signal 414, while the AO pressure rise 422 and dicrotic notch 423 can be identified in the patient's AO pressure signal 412. The ECG signal 414 and AO pressure signal 412 acquired during intravascular and angiographic imaging are synchronized with the captured image dataset. As previously described, the ECG and AO pressure signals acquired during the initial registration of intravascular-angiographic images can be synchronized with the live ECG and AO pressure signals to further synchronize the live fluoroscopic images with the initially registered intravascular and angiographic images. Figure 4B The vertical grid 430 in the image corresponds to time slices or bars in portions of the ECG signal 414 and AO signal 412 that relate to the cardiac cycle, all of which are associated with specific angiographic image frames 442-448. For example, angiographic image frame 442 is obtained during the period when the AO pressure signal 412 increases from a minimum to a maximum. Thus, angiographic image frame 442 is identified as associated with this portion of the AO pressure signal 412. Angiographic image frames 444 and 446 are obtained at the beginning and end of the dicrotic notch within the AO pressure signal 412, respectively. Similarly, angiographic image frame 448 (obtained during the ECG pulse) is associated with the corresponding time period shown in the ECG signal 414. This process can be performed for each intravascular and angiographic image obtained, such that each intravascular-angiographic image is associated with a specific time period within the patient's cardiac cycle.

[0075] Although Figure 4B This shows that a single cardiac cycle is broken down into a series of time slices, but multiple cardiac cycles can be combined to perform the same division. Furthermore, the number of time slices can vary. For example, Figure 1A and 1B The system described herein can be configured to capture OCT / IVUS images and angiography images at different frame rates, which can be configured by the user. For example, the disclosed system can be configured by the user to capture angiography images at 15 frames per second or 30 frames per second. Similarly, the disclosed system can be configured to divide ECG and AO pressure signals into time slices of different durations. If the ECG and AO pressure signals are divided into 30 time slices per second and angiography images are captured at 30 frames per second, the system can be configured to associate one angiography image for each time slice. If the ECG and AO pressure signals are divided into 15 time slices per second and angiography images are captured at a rate of 30 images per second, multiple angiography images can be assigned to a particular time slice. Likewise, if the number of time slices is greater than the number of angiography images captured in a particular time period, only some time slices will be associated with angiography images. As previously described, based on the location of markers in the intravascular images and the timing system used between the two imaging modalities, angiography frames can also be registered with simultaneously acquired OCT or other intravascular images.

[0076] Once angiographic images have been associated with a specific segment or time frame of the patient's cardiac cycle data, the disclosed systems and methods can identify angiographic image frames corresponding to on-site fluoroscopic images based on real-time correlation with on-site ECG and AO signals. For example, Figure 5 The diagram illustrates a live fluoroscopy image 510 and live ECG and AO pressure signals 520, wherein the live fluoroscopy image 510 is associated with a specific set of ECG and AO pressure signals acquired simultaneously at time 522. This live ECG and AO pressure signal 520 can also be associated with previously acquired ECG and AO signals to support association and registration of the live fluoroscopy image 510 with a library of previously acquired OCT / IVUS and angiography images. For example, the disclosed system can identify one or more previously captured angiography images in the same portion of the patient's cardiac cycle as the live fluoroscopy image 510 (determined based on ECG and AO pressure data). Thus, the disclosed system can track ECG and AO signals with respect to the live fluoroscopy image and identify corresponding ECG and AO signals with respect to previously captured intravascular and angiography images.

[0077] For example, Figure 4B The timing slice 430 of the ECG signal 414 and AO signal 412 shown can be associated with... Figure 5 The ECG and AO signals 520 are shown in the diagram. (As shown...) Figure 6 As shown, time slice 630 of ECG and AO pressure signals 420 is determined to correspond to ECG and AO signals 520 at time 522, because they both show the patient's cardiac cycle portion where the corresponding ECG pulse appears. In this way, the disclosed system determines that angiographic image 448 corresponds to the same patient cardiac cycle portion as the on-site fluoroscopic image 510. Based on this identified association with previously acquired ECG and AO pressure signals 420, on-site ECG and AO signals 520 can be used as timing signals to depict off-site data, including previously captured OCT and angiographic image data. Thus, angiographic images 442-448 for each time slice can be associated with corresponding portions of on-site ECG and AO signals 520.

[0078] Based on the correlation between off-site and on-site signals, angiography image frames can be combined with on-site fluoroscopy to reduce the amount of contrast solution used. For example, Figure 7A series of on-site fluoroscopic images 702, 704, and 706 are displayed, wherein fluoroscopic image frame 704 has been replaced in real-time with angiographic image frame 710. As previously described, the disclosed system identifies, based on the patient's cardiac signals, that angiographic image frame 710 corresponds to the same portion of the patient's cardiac cycle as on-site fluoroscopic image frame 704. In this way, angiographic and fluoroscopic images can be presented to the physician simultaneously within a single series of image frames. This allows the physician to better track the position of various devices and stents within the on-site fluoroscopic images by using previously captured angiographic images as a reference. Although... Figure 7 The fluoroscopy image 704 is shown to be replaced by an angiography image 710; however, the interleaving of angiography images can be performed without removing any on-site fluoroscopy image frames. For example, one or more angiography image frames can be inserted between on-site fluoroscopy image frames to present combined frames at a higher frame rate. Alternatively, one or more on-site fluoroscopy image frames can be replaced with one or more corresponding angiography image frames. Furthermore, the disclosed system allows the user to select the number of successive fluoroscopy and angiography images to be displayed. For example, the user can configure the system to present a series of three on-site fluoroscopy image frames followed by two successive angiography image frames, or the user can configure the system to display one angiography image within each series of four on-site fluoroscopy images. The user can also configure the frame rate at which successive fluoroscopy and angiography images are displayed. In this way, the user can control how successive on-site fluoroscopy images and off-site angiography images are displayed.

[0079] Furthermore, based on the foregoing aspects of this disclosure, off-site image data can be overlaid onto on-site fluorescence imaging. For example, Figure 8 The system displays a live fluoroscopic image 810, overlaid with stent planning markers 812, 814, and 816. These stent planning markers 812-816 can be based on markers placed within a series of angiographic images. The relative positions of these markers will move from one angiographic image to another because the patient's cardiac cycle causes movement of the various arteries within the heart. However, by associating both the angiographic and fluoroscopic images with the patient's cardiac cycle, stent planning markers 812-814 can be overlaid onto each fluoroscopic image in a manner that maintains their correct position relative to the artery where the stent is to be placed. In this way, the system provides more accurate placement of stent planning markers from OCT-angiography images to the live fluoroscopic feed. These markers and other identifiers help reduce morphological errors by ensuring that physicians can accurately identify the areas they have planned for OCT. Other useful intravascular-angiographic data can also be overlaid onto the fluoroscopic images, including, without limitation, data acquired from IVUS images.

[0080] Figure 9 Flowchart 900 provides an example, thereby enabling Figure 1A and 1B The system shown can provide the user with an interwoven display of off-site and on-site images, where the images are presented sequentially, simultaneously displaying on-site and off-site images corresponding to the patient's cardiac cycle. Although Figure 9 The operation blocks are provided in a specific order, but one or more processors of the disclosed system may be configured to add, remove, or switch the order of operations according to the method and system scheme. As provided in block 902, the system may collect multiple first sets of images, as well as a first set of time-varying cardiac cycle data. As previously described, the multiple first sets of images may include angiographic images and registered intravascular images, such as OCT images or IVUS images. The time-varying cardiac cycle data may include: data showing ECG signals, AO pressure data, or other time-varying data relating to the patient's cardiac cycle (which is collected when the first set of images is captured). In block 904, the collected first set of images is associated with a specific subset of the first set of time-varying data. An example of this association is shown in... Figure 4B In this context, the angiographic images are associated with time-varying ECG and AO signal data (based on the time period in which the angiographic images were captured). Associating the collected images with time-varying data may include storing the images and time-varying data in a computer storage medium in a manner that identifies the relationship between a specific image and a specific subgroup of time-varying data. Thus, each image in the first set of images can be associated with a specific portion of the patient's cardiac cycle. For box 906, a second set of images is collected together with a subsequent set of time-varying cardiac cycle data. As previously described, the second set of images may be in-situ fluoroscopic images, which are collected together with the patient's in-situ cardiac cycle data. This subsequent set of in-situ cardiac cycle data can be associated with the first set of time-varying cardiac cycle data, as provided in box 908.

[0081] As previously described, a patient's cardiac cycle contains recurring patterns, such as recurring pressure rises, dicrotic notches, and ECG pulses. According to the disclosed system and method, these features of the live cardiac cycle data can be correlated with or matched to a first set of cardiac cycle data. In block 910, the system identifies one or more images from the first set that have similar time-varying cardiac cycle data to one or more images from the second set. (As in conjunction with...) Figure 6 The system can identify angiographic image 448 and registered intravascular image (which corresponds to a period in the patient’s cardiac cycle similar to that in on-site fluoroscopic image 510) by comparing on-site ECG and AO pressure data with off-site ECG and AO pressure data.

[0082] Returning to flowchart 900, the system can then display an image sequence including a second set of images interleaved with one or more images from the first set (which also correspond to the same portion of the patient's cardiac cycle). For example, in-situ fluoroscopy images can be interleaved with off-site angiography images. As previously described, off-site image interleaving can include replacing one or more in-situ fluoroscopy images with off-site angiography images, wherein both the replaced in-situ fluoroscopy images and the selected off-site angiography images are captured in similar or corresponding portions of the patient's cardiac cycle. Off-site image interleaving can also include inserting (rather than replacing) one or more off-site angiography images between in-situ fluoroscopy images captured in similar portions of the patient's cardiac cycle (based on the identification performed in block 910). Angiography images can also be interleaved with in-situ fluoroscopy images by displaying the corresponding angiography image as a plot within a display of the in-situ fluoroscopy images. Furthermore, the display of interleaved angiography images can include displaying intravascular images (such as OCT images or IVUS images) that have been registered with the angiography images. The registered intravascular frames can be displayed on the same or different monitors as the angiography and fluoroscopy images, and can be shown as a plot within the fluoroscopy and angiography images. As shown in box 914, the system can determine whether the patient imaging phase continues; if so, the system can return to box 906, where additional second-type images and another set of time-varying cardiac cycle data are collected. If the received input indicates that the patient imaging phase is complete, the process can reach its endpoint.

[0083] Non-limiting software features and implementations for performing on-site fluorescence imaging combined with other data (such as image data). Regulations This disclosure relates in part to computer-based methods, systems, and apparatus for visualizing data relative to in-situ fluoroscopy data. In one embodiment, this disclosure relates to interleaving pre-computed angiographic images with in-situ fluoroscopy images. Image segmentation can be performed using various techniques, such as artificial intelligence (AI) or machine learning, etc.

[0084] These evaluation methods may include displaying one or more arterial views from angiography or intravascular imaging relative to one or more frames of in-situ fluoroscopic imaging. Various fluoroscopic-based methods reduce topographic errors and contribute to better imaging and arterial guidance processing. In one embodiment, the method is performed automatically. A stent inserted in in-situ fluoroscopic mode can be placed in a positioning area planned using an OCT / IVUS angiography registration system and method.

[0085] The systems and methods disclosed herein can perform the various steps described herein (e.g., assessing a detected stent against a detected luminal profile, calculating stent expansion, calculating MSA, measuring stent parameters, and displaying the level of stent expansion along the artery in different frames) and other features and methods disclosed herein. Furthermore, the system may include registration software that registers angiographic data and intravascular data to display stent expansion data relative to the angiographic data. In one embodiment, on-site fluorescence fluoroscopy data is interleaved with data frames from one or more intravascular imaging pull-back stages (where the probe is pulled back through a section of the artery) and one or more angiographic data collection stages, as well as one or more registration timing signals (e.g., AO pressure, ECG signals, and other signals disclosed herein).

[0086] The following description is intended to provide an overview of the apparatus hardware and other operating components suitable for performing the methods disclosed herein. This description is not intended to limit the applicable environment or scope of this disclosure. Similarly, the hardware and other operating components may be suitable as part of the aforementioned apparatus. This disclosure can be implemented using other system configurations, including personal computers (PCs), multiprocessor systems, microprocessor-based or programmable electronic devices, network PCs, minicomputers, mainframe computers, and so on. This disclosure can also be implemented in a distributed computing environment, where tasks are performed via remote processing devices (e.g., located in different rooms of a catheterization lab) linked through a communication network.

[0087] Some parts of the detailed description are presented according to the algorithmic and symbolic representation of data bits in computer memory. These algorithmic descriptions and representations are usable by those skilled in the art of computers and software. In one embodiment, the algorithm is typically designed here to elicit a self-consistent sequence of operations that yields the desired result. Operations performed when the method stops or proceeds in other ways described herein require physical manipulation of physical quantities. Typically (but not necessarily), these quantities take the form of electrical or magnetic signals that can be stored, transmitted, combined, transformed, compared, and otherwise manipulated.

[0088] Unless otherwise explicitly stated (as will be apparent in the following discussion), it should be understood that throughout the specification, the use of terms such as processing, or calculating, or superimposing, or searching, or probing, or measuring, or calculating, or comparing, generating, or determining, or displaying, or Boolean logic or other setting related operations or the like, refers to the actions and processing of a computer system or electronic device that manipulate and convert data (represented as physical (electronic) quantities in the registers and memories of a computer system or electronic device) into other data (which are similarly represented as physical quantities in electronic memory or registers or other such information storage, transmission or display devices).

[0089] This disclosure also relates in some embodiments to a device for performing the operations described herein. This device may be specifically constructed for a desired purpose, or it may include a general-purpose computer that can be selectively started or reconfigured by a computer program stored in a computer.

[0090] This disclosure can be implemented in a variety of different forms, including, but not limited to: computer program logic for a processor (e.g., a microprocessor, microcontroller, digital signal processor, or general-purpose computer); programmable logic for a programmable logic device (e.g., a field-programmable gate array (FPGA) or other programmable logic device); discrete components; integrated circuits (e.g., application-specific integrated circuits (ASICs)); or any other structure including any combination thereof. In a typical embodiment of this disclosure, some or all of the processing of data collected using an OCT or IVUS probe and a processor-based system is implemented as a set of computer program instructions, which are converted into a computer-executable form, for example, stored in a computer-readable medium and executed by a microprocessor under the control of an operating system. Thus, query responses and input data are transformed into processor-understandable instructions suitable for generating imaging data, detecting lumen boundaries, detecting stent struts, comparing measured vertical distances relative to a set threshold, and otherwise performing image comparison, signal processing, lumen detection, stent detection and comparison of detected stents, as well as the other features and embodiments described above.

[0091] The computer program logic that implements all or part of the functions described earlier in this document can be implemented in various forms, including but not limited to: source code form, computer-executable form, and various intermediate forms (e.g., forms generated by an assembler, compiler, linker, or locator). Source code may include a set of computer program instructions implemented in any variety of programming languages ​​(e.g., object code, assembly language, or high-level languages ​​such as Fortran, C, C++, JAVA, or HTML) for various operating systems or operating environments. Source code can define and use various data structures and communication messages. Source code may be in a computer-executable form (e.g., via an interpreter), or source code may be converted (e.g., via a decoder, assembler, or compiler) into a computer-executable form.

[0092] Computer programs can be persistently or temporarily embedded in physical storage media in any form (e.g., source code, computer-executable, or intermediate form), such as semiconductor memory devices (e.g., random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), extended erasable programmable read-only memory (EEPROM), or flash programmable RAM), magnetic memory devices (e.g., disks or fixed disks), optical memory devices (e.g., optical disc read-only memory (CD-ROM)), PC cards (e.g., PCMCIA cards), or other memory devices. Computer programs can be embedded in signals that can be transmitted to a computer using any variety of communication technologies (including, but not limited to, analog, digital, optical, wireless technologies (e.g., Bluetooth), networking technologies, and Internet technologies). Computer programs can be distributed in any form as removable storage media having printed or electronic documentation (e.g., shrink wrap), pre-loaded with a computer system (e.g., on a system ROM or fixed disk), or distributed from a server or electronic bulletin board on a communication system (e.g., the Internet or the World Wide Web).

[0093] The hardware logic that implements all or part of the functions described above (including programmable logic for programmable logic devices) can be designed using conventional manual methods or can be electronically designed, captured, simulated, or documented using various tools, such as computer-aided design (CAD), hardware description languages ​​(e.g., VHDL or AHDL), or programmable logic device (PLD) programming languages ​​(e.g., PALASM, ABEL, or CUPL).

[0094] Programmable logic can be permanently or temporarily embedded in a physical storage medium, such as a semiconductor memory device (e.g., random access memory (RAM), read-only memory (ROM), programmable read-only memory (PROM), electronically erasable programmable read-only memory (EEPROM), or flash programmable RAM), a magnetic memory device (e.g., a magnetic disk or fixed disk), an optical memory device (e.g., an optical disc read-only memory (CD-ROM)), or other memory devices. Programmable logic can be embedded in signals that can be transmitted to a computer using any variety of communication technologies, including but not limited to analog, digital, optical, wireless (e.g., Bluetooth), networking, and Internet technologies. Programmable logic can be allocated as a removable storage medium containing printed or electronic documents (e.g., shrink wrap), pre-loaded with a computer system (e.g., on a system ROM or fixed disk), or allocated from a server or electronic bulletin board on a communication system (e.g., the Internet or the World Wide Web).

[0095] Various examples suitable for processing modules are discussed in more detail below. As used herein, a module refers to software, hardware, or firmware suitable for performing a specific data processing or data transfer task. Typically, in a preferred embodiment, a module refers to a software routine, program, or other store-resident application suitable for receiving, transforming, routing, and processing instructions or various types of data, such as OCT scan data, IVUS scan data, interferometer signal data, target stent profile, subsequent stent deployment lumen profile and image, interpolated lumen profile view indicating a fully expanded stent, geometric ratio of the expanded stent lumen profile to the fully expanded lumen profile, stent expansion level indicators (color, shading, etc.), highlight / enhancement pixel performance, side branch position, side branch diameter, stent expansion percentage or fraction, pre-stent setting FFR value, subsequent stent setting FFR value, and other pre- and subsequent stent setting values ​​and other information of interest.

[0096] The computers and computer systems described herein may include operatively associated computer-readable media, such as memory, for storing software applications for acquiring, processing, storing, and / or communicating data. It will be appreciated that such memory may be internal, external, remote, or local relative to its operatively associated computer or computer system.

[0097] The memory may also include any structure for storing software or other instructions, such as, without limitation, hard disks, optical disks, floppy disks, DVDs (Digital Video Optical Discs), CDs (DCDs), Memory Sticks, flash memory, ROMs (Read-Only Memory), RAMs (Random Access Memory), DRAMs (Dynamic Random Access Memory), PROMs (Programmable ROMs), EEPROMs (Extended Erasable PROMs), and / or other similar computer-readable media.

[0098] Generally, suitable computer-readable storage media associated with embodiments of the present disclosure described herein may include any storage medium capable of storing instructions executable by a programmable device. Where available, the method steps described herein may be implemented or executed as instructions stored on one or more computer-readable storage media. These instructions may be software implemented in various programming languages ​​(e.g., C++, C, Java) and / or various other types of software programming languages ​​applicable to forming instructions according to embodiments of the present disclosure.

[0099] Storage media can be non-transitory or include non-transitory devices / apparatus. Therefore, a non-transitory storage medium or a non-transitory device / apparatus can include a physical device / apparatus, meaning that the device / apparatus has a tangible physical form, although its physical state can be changed. Thus, for example, non-transitory means that the device / apparatus remains physical unless such a change of state occurs.

[0100] The schemes, embodiments, features, and examples of this disclosure should be considered illustrative in all respects and not intended to limit the scope of this disclosure, which is defined only by the claims. Other embodiments, modifications, and uses will become apparent to those skilled in the art without departing from the spirit and scope of the claimed disclosure.

[0101] The use of headings and sections in this application is not intended to limit the scope of this disclosure; each section may be applied to any scheme, embodiment or feature of this disclosure.

[0102] Throughout this application, each component is described as having, including, or containing specific parts, or each process is described as having, including, or containing specific process steps. It should be understood that each component of this teaching is also substantially constituted or constituted by the said parts, and each process of this teaching is also substantially constituted or constituted by the said process steps.

[0103] In this application, elements or components are referred to as being included in and / or selected from a list of said elements or components. It should be understood that said element or component may be any one of said elements or components and may be selected from a group consisting of two or more said elements or components. Furthermore, it should be understood that elements and / or features of the components, devices, or methods described herein may be combined in various ways, whether express or implied herein, without departing from the spirit and scope of this teaching.

[0104] The use of the words “including”, “having”, and their tense variations should generally be understood as open-ended and non-restrictive, unless otherwise specifically indicated.

[0105] As used herein, the singular includes the plural (and vice versa), unless otherwise specifically indicated. Additionally, the singular forms “a” and “the” include the plural forms, unless the context clearly indicates otherwise. Furthermore, if the terms “about” or “approximately” are used before a quantity, this teaching also includes the specific quantity itself, unless otherwise specifically indicated. As used herein, the terms “about” and “approximately” refer to possible variations in a numerical quantity, for example, due to measurement or processing in the real world, due to unintentional errors in these processes, due to differences / defects in material manufacturing (e.g., defects in composites), and equivalent variations that a person skilled in the art would recognize (provided such variations do not cover values ​​known from prior art practice). Typically, the terms “about” and “approximately” mean: a value or range greater than or less than 1 / 10, for example, ±10%.

[0106] It should be understood that the order of the steps or the order in which specific actions are performed is not important, as long as the instruction remains operational. Furthermore, two or more steps or actions may be performed simultaneously.

[0107] The use of headings and paragraphs in this application is not intended to limit the scope of this disclosure; each paragraph may be applied to any scheme, embodiment, or feature of this disclosure. Only claims using the phrase "intended for use with" are intended to be interpreted based on paragraph 6 of 35 USC 112. If a claim does not contain the expression "intended for use with," such claim shall be considered not based on 35 USC 112. Limitations in the specification are not intended to be read into any claim unless such limitation is expressly included in the claim.

[0108] When a value or range of values ​​is given, each value and endpoint of the given range, as well as the values ​​between the endpoints, may be increased or decreased by 20% while still remaining within the teachings of this disclosure, unless some different range is explicitly stated.

[0109] When a list of ranges or values ​​is provided, each intermediate value between the upper and lower limits of the range or value list applies individually and is covered within the scope of this disclosure, as each value is specifically listed herein. Furthermore, smaller ranges between the upper and lower limits of a given range (inclusive) apply and are covered within the scope of this disclosure. The exemplary list of values ​​or ranges does not exclude other values ​​or ranges between the upper and lower limits of a given range (inclusive).

[0110] It should be understood that the figures and descriptions in this disclosure have been simplified to illustrate relevant elements for clear understanding of this disclosure, while other elements have been omitted for clarity. However, those skilled in the art will recognize that these and other elements may be desirable. However, since such elements are well-known in the art and because they are not conducive to a better understanding of this disclosure, such elements will not be discussed herein. It should be understood that the figures are presented for illustrative purposes and not as construction diagrams. Omitted details and modifications or alternative embodiments are within the view of those skilled in the art.

[0111] It will be appreciated that in certain embodiments of this disclosure, a single component may be replaced by multiple components, and multiple components may be replaced by a single component, to provide an element or structure or to perform a given function or one or more functions. Such substitutions are considered to be within the scope of this disclosure unless they are not operationally feasible for carrying out the specific embodiments of this disclosure.

[0112] The examples presented herein are intended to illustrate potential and specific implementations of this disclosure. It will be appreciated that the examples are primarily intended to illustrate the disclosure to those skilled in the art. Variations of these illustrations or operations may exist without departing from the spirit of this disclosure. For example, in certain cases, method steps or operations may be performed or executed in a different order, or operations may be added, deleted, or modified.

Claims

1. A method for displaying an image of one or more blood vessels, comprising: A set of captured images of one or more blood vessels and cardiac cycle data are acquired through one or more processors; Each image is associated with a portion of the cardiac cycle data based on the capture time of each image from the first set of captured images by the one or more processors. The processor acquires on-site images of the one or more blood vessels and on-site cardiac cycle data. The processor identifies one or more captured images from the set of captured images for display between the field images, wherein the one or more captured images are added to the field images and placed between the field images based on the field cardiac cycle data and portions of cardiac cycle data already associated with the one or more images; as well as The processor provides a display of the following: a series of field images of the one or more blood vessels, and the one or more captured images that are added to the series of field images and displayed between the field images in the series.

2. The method of claim 1, further comprising receiving a set of intravascular image frames while capturing the set of captured images, the intravascular image frames being generated by intravascular imaging of one of the blood vessels using an intravascular probe having one or more opaque markers.

3. The method of claim 2, further comprising registering the set of intravascular image frames and the set of captured images.

4. The method of claim 3, further comprising displaying at least one subgroup of one or more intravascular image frames and one or more of the field images.

5. The method of claim 1, further comprising placing the one or more captured images between the scene images by replacing one or more of the scene images with the one or more captured images.

6. A system for displaying images of one or more blood vessels, comprising: A memory used to store image data of one or more blood vessels; as well as One or more processors communicating with the memory, the one or more processors being configured to: Acquire a set of captured images of one or more blood vessels, along with cardiac cycle data; Based on the capture time of each image from the first set of captured images, each image is associated with a portion of the cardiac cycle data; Acquire on-site images and on-site cardiac cycle data of the one or more blood vessels; One or more captured images are identified from the set of captured images for display between the scene images, wherein the one or more captured images are added to the scene images and placed between the scene images based on the scene cardiac cycle data and cardiac cycle data already associated with the one or more images; and Provides a display of the following: a series of field images of the one or more blood vessels, and the one or more captured images that are added to the series of field images and displayed between the field images in the series.

7. The system according to claim 6, wherein, The set of captured images are angiographic images, and the on-site images are fluorescence fluoroscopic images.

8. The system according to claim 7, wherein, The fluorescence imaging is a live image of the subject during intravascular surgery.

9. The system according to claim 6, wherein, The cardiac cycle data includes aortic (AO) pressure values.

10. The system according to claim 6, wherein, The cardiac cycle data includes ECG values.

11. The system according to claim 6, wherein, The one or more processors are further configured to control an intravascular probe with one or more opaque markers to generate a set of intravascular image frames and the set of captured images.

12. The system according to claim 11, wherein, The one or more processors are further configured to register the set of intravascular image frames and the set of captured images.

13. The system according to claim 12, wherein, The one or more processors are further configured to provide the display of at least one subgroup of one or more intravascular image frames and one or more of the field images.

14. The system according to claim 6, wherein, The one or more processors are further configured to place the one or more captured images between the scene images by replacing one or more of the scene images with the one or more captured images.

15. The system according to claim 14, wherein, Each of the one or more captured images identified from the set of captured images, as well as the replaced field images, is captured in the corresponding portion of the cardiac cycle.