System and method for generating reconstructed images for interventional medical procedures
The ultrasound system automates the acquisition and reconstruction of anatomical images to improve the accuracy and efficiency of interventional procedures by reducing manual operation, enabling real-time, procedure-specific guidance.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Filing Date
- 2021-12-06
- Publication Date
- 2026-03-17
AI Technical Summary
Existing ultrasound imaging systems require significant manual operation and skill to acquire precise anatomical views during interventional procedures, leading to increased procedure time and difficulty in positioning interventional devices accurately.
An ultrasound system that automates the acquisition and reconstruction of anatomical images using 3D data, identifying landmarks, and generating procedure-specific views to guide clinicians, reducing the need for manual manipulation of the ultrasound probe.
Improves the accuracy and efficiency of interventional procedures by providing real-time, automated image guidance, shortening procedure times and enhancing the reliability of ultrasound image acquisition.
Smart Images

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Abstract
Description
Technical Field
[0001]
[0001] This application relates to a system configured to generate ultrasound images necessary for performing various interventional medical procedures. More particularly, this application relates to a system and method for reducing dependence on manual input and generating a reconstructed view of anatomical features with improved efficiency and accuracy during interventional medical procedures.
Background Art
[0002]
[0002] Positioning interventional devices such as catheters extremely accurately is essential for many medical procedures, such as interventional cardiac procedures. For these reasons, clinicians performing such procedures often rely on high-resolution ultrasound imaging for precise real-time guidance. Ultrasound imaging is certainly useful for guiding the placement of interventional devices such as stents, but in order to position such devices with high precision, it is usually necessary to acquire at least one anatomical feature, such as multiple different views of a heart valve, during the course of a given procedure. Using existing ultrasound technology, images along the plane necessary to guide the clinician can be acquired through the image acquisition process, but such technology requires significant and often difficult manual operation of the ultrasound probe and ultrasound system. Therefore, the clinician must demonstrate consistent acquisition of the placement of the ultrasound transducer tip and the manipulation of 2D planes from 3D volumes in order to obtain the best possible view of the anatomical features. Such skills typically require repetitive adjustments on behalf of the clinician throughout a given operation, which makes it even more difficult to perform interventional procedures within a small anatomical volume, and may significantly increase the procedure time or make effective treatment difficult.
Summary of the Invention
Problems to be Solved by the Invention
[0003] A new ultrasound system is needed that is configured to improve the accuracy and consistency of interventional procedures using a computationally efficient method. [Means for solving the problem]
[0004]
[0003] Systems and methods for providing more efficient and accurate ultrasound image guidance during interventional medical procedures are disclosed. Examples include automating the ultrasound data acquisition steps necessary to acquire anatomical images along a specific image plane in real time. Such examples include acquiring volumetric image data of a region of interest using 3D ultrasound, transmitting the acquired volumetric image data to a processor configured to identify anatomical landmarks in the volumetric data, and automatically reconstructing a specific view of one or more regions of interest based on the identified anatomical landmarks. The reconstructed view can then be used to guide a clinician performing an interventional medical procedure, including the placement of one or more interventional instruments, such as catheters and / or implants, in specific anatomical locations, such as blood vessels and / or valves. Unlike existing systems, a user interface coupled with the ultrasound acquisition system may be configured to display procedure-specific graphics, user input selections, and / or instructions for the procedure in response to receiving a procedure selection and / or the system detecting one or more anatomical features. Thus, the display shown in the user interface is tailored to the currently selected procedure. The examples described herein are performed regardless of the relative position and orientation of the ultrasonic transducer to the region of interest, as long as the region of interest is adequately captured within the initially acquired volumetric image data.
[0005]
[0004] According to at least one example disclosed herein, the ultrasound system includes a user interface configured to receive user input indicating a selection of an interventional medical procedure. The system also includes an ultrasound probe configured to transmit an ultrasound signal in a target area, receive echoes in response to the ultrasound signal, and generate radio frequency (RF) data corresponding to the echoes. The system also includes an image processor configured to generate image data from the RF data. Non-limiting examples of such image data may include channel-by-channel data, pre-beamforming data, post-beamforming data, log detection data, scan transformation data, and echo data processed in 2D and / or 3D. The system may also include an anatomical recognition processor configured to receive the image data and identify anatomical landmarks within the image data. The system may also include an image reconstruction processor configured to generate a planar ultrasound image along the image plane relevant to the selected interventional medical procedure based on the anatomical landmarks identified within the image data. The user interface may be configured to display the planar ultrasound image during the interventional medical procedure.
[0006]
[0005] In some examples, the interventional medical procedure includes cardiovascular valve clipping, annuloplasty, or left atrial appendage closure. In some embodiments, the image data includes 3D data acquired via volume imaging mode. In some embodiments, the user interface is further configured to receive instructions for the implantation site specific to the procedure. In some embodiments, the image reconstruction processor is configured to generate at least two planar ultrasound images along at least two image planes associated with the selected interventional medical procedure, based on anatomical landmarks identified in the image data and the interventional devices required to perform the interventional medical procedure. In some embodiments, the user interface is configured to display the images sequentially as the interventional medical procedure is being performed. In some embodiments, the system further includes a controller configured to cause the ultrasound probe to stop transmitting ultrasound signals except for the ultrasound signals required to generate the planar ultrasound image planes associated with the selected interventional medical procedure.
[0007]
[0006] In some examples, the user interface is configured to receive confirmation that a step in the selected interventional medical procedure has been performed. In some embodiments, based on the confirmation, the user interface is configured to display a second planar ultrasound image necessary to perform subsequent steps in the selected interventional medical procedure. In some examples, the image reconstruction processor is configured to generate planar ultrasound images in real time along the image plane associated with the selected interventional medical procedure. In some embodiments, the image reconstruction processor is configured to optimize the scanning sequence of the image plane associated with the selected interventional medical procedure at intervals or on a periodic basis. In some examples, the anatomical recognition processor is further configured to generate an indication that the image data is insufficient to identify anatomical landmarks. In some embodiments, the image plane is a 2D image plane.
[0008]
[0007] According to at least one example disclosed herein, the method may include the steps of receiving user input indicating a selection of an interventional medical procedure, and acquiring image data by transmitting an ultrasound signal to a target region and receiving echoes from the target region in response to the ultrasound signal. The method includes the step of automatically identifying anatomical landmarks in the image data. The method further includes the steps of automatically generating a planar ultrasound image along the image plane associated with the selected interventional medical procedure based on the anatomical landmarks identified in the image data, and displaying the planar ultrasound image during the interventional medical procedure.
[0009]
[0008] In some examples, the interventional medical procedure includes a cardiovascular valve clipping procedure, annuloplasty procedure, or left atrial appendage closure procedure. In some examples, the method further includes a step of receiving instructions for a procedure-specific implantation site. In some examples, the method further includes a step of stopping the acquisition of image data except for the image data required to generate a planar ultrasound image along the image plane associated with the selected interventional medical procedure. In some examples, the method further includes a step of receiving confirmation that a step in the selected interventional medical procedure has been performed. In some examples, the method further includes a step of displaying a second planar ultrasound image required to perform a subsequent step in the selected interventional medical procedure based on the confirmation. An example is having a step of generating a planar ultrasound image along the image plane associated with the selected interventional medical procedure in real time. An example is having a step of optimizing the scanning sequence of the image plane associated with the selected interventional medical procedure at intervals or on a periodic basis. In some examples, the method has a step of generating instructions that the image data is insufficient to identify anatomical landmarks. [Brief explanation of the drawing]
[0010] [Figure 1]
[0009] This is a block diagram of an ultrasonic imaging system configured in accordance with the principles of the present disclosure. [Figure 2]
[0010] This is a block diagram illustrating an exemplary processor according to the principles of the present disclosure. [Figure 3]
[0011] This figure shows a graphical representation of a scanning sequence optimization scheme implemented according to an embodiment of the present disclosure. [Figure 4]
[0012] This is a flowchart illustrating an exemplary process carried out in accordance with the embodiments of this disclosure. [Figure 5]
[0013] This is a flowchart illustrating an exemplary method implemented in accordance with the principles of this disclosure. [Figure 6]
[0014] This figure shows an exemplary image view required to perform a cardiovascular valve clipping procedure. [Figure 7]
[0015] Figure 6 shows an exemplary image view required to perform a cardiovascular valve clipping procedure. [Figure 8]
[0016] Figure 6 shows the graphics displayed on the user interface as the cardiovascular valve clipping procedure is performed. [Figure 9]
[0017] This is a flowchart of the method implemented for valve clip image guidance in accordance with the principles of this disclosure. [Figure 10]
[0018] This is an exemplary image view necessary for performing a cardiovascular annuloplasty procedure. [Figure 11]
[0019] This figure shows the graphics displayed on the user interface in accordance with the execution of the valve ring formation procedure shown in Figure 10, according to an embodiment of the present disclosure. [Figure 12]
[0020] This is a volume image of the valve ring generated according to the embodiments of this disclosure. [Figure 13]
[0021] A volume image of the valve annulus of FIG. 12 showing a procedure-specific label generated in accordance with an embodiment of the present disclosure. [Figure 14]
[0022] A flowchart of a method implemented for valve annulus formation image guidance in accordance with the principles of the present disclosure. [Figure 15]
[0023] A diagram showing graphics used to perform a left atrial appendage closure procedure in accordance with an embodiment of the present disclosure. [Figure 16]
[0024] A flowchart of an exemplary left atrial appendage closure procedure performed in accordance with an embodiment of the present disclosure. [Figure 17]
[0025] A flowchart of an exemplary method performed in accordance with an embodiment of the present disclosure.
DETAILED DESCRIPTION OF THE INVENTION
[0011]
[0026] The following description of an example is in no way intended to limit the present disclosure or its application or use. In the following detailed description of examples of the system and method, reference is made to the accompanying drawings which form a part hereof, and in which are shown by way of illustration specific examples in which the described system and method are practiced. These examples are described in sufficient detail to enable those skilled in the art to practice the system and method of the present disclosure, it being understood that other examples are available and that logical changes may be made without departing from the spirit and scope of the present disclosure. Further, for the sake of clarity, detailed descriptions of specific features which would be apparent to those skilled in the art are not described where they would not obscure the description of the present disclosure. Accordingly, the following detailed description is not to be construed in a limiting sense, and the scope of the system and method is defined only by the appended claims.
[0012]
[0027] Disclosed are an ultrasound system configured to provide image guidance for interventional medical procedures, and related methods for automating the steps necessary to acquire, display, and adjust specific images in real time for a user performing the procedure, such as a clinician. In some examples, volumetric image data of a region of interest ("ROI") is acquired by an ultrasound transducer configured to perform 3D imaging. The acquired image data can be transmitted to at least one computer processor having an anatomical recognition processor configured to identify anatomical landmarks in the acquired image data. The image reconstruction processor can generate at least one image of anatomical features along at least one imaging plane necessary to perform the interventional procedure, based at least partially on the identified landmarks. A user interface communicatively coupled with the anatomical recognition processor and the reconstruction processor can display the reconstructed image to the user during the interventional procedure. Thus, the selection of an interventional procedure via the user interface indicates which anatomical landmarks are relevant to acquiring the images necessary to perform the procedure. The necessary images are then automatically generated along a specific plane and / or from favorable points on a specific volume, with little or no manual operation of the ultrasound transducer by the user. The user interface included in the disclosed system can be used to verify that the necessary images have been acquired and to adapt to the progress and / or deviations of the procedure from the pre-procedure plan. Image data acquired by other non-ultrasound imaging modalities, such as MRI, CT, or X-ray, can be used in conjunction with the disclosed system to further improve the accuracy and efficiency of detecting anatomical features and displaying images along one or more specific imaging planes of those anatomical features.
[0013]
[0028] In some embodiments, reconstructed images may be generated by collecting volume data acquired for a subset of planar or volume data specific to a selected interventional procedure. Additionally, or alternatively, reconstructed images can be generated by modifying the ultrasound scanning sequence used to acquire image data in a manner designed to improve image quality by generating an optimal anatomical view. Examples include manipulating the imaging plane and / or truncating scan frames and scan lines to prioritize acquiring only the scan lines necessary to generate the optimal view related to the procedure, while omitting unnecessary acquisitions. Other examples include automatically cropping or selectively deleting unnecessary imaging data from the initially acquired volume data, and displaying only the retained data in the form of one or more images. By implementing one or more of the aforementioned image processing means, improvements in the spatial resolution of the desired image can be achieved in a faster and more computationally efficient manner.
[0014]
[0029] The automated generation of image views used to guide interventional procedures represents a significant improvement over existing systems where users must manually capture the same views. Such automation also facilitates fast and effective user navigation between required views encompassing various organs, such as the heart. Reducing the frequency of manual ultrasound probe manipulation improves the efficiency and accuracy of target ultrasound image acquisition, resulting in shorter procedure times and increased reliability of ultrasound images in response to real-time user input.
[0015]
[0030] Figure 1 shows a block diagram of an exemplary ultrasound imaging system 100 constructed in accordance with the principles of this disclosure. As shown, the system 100 includes a transducer array 114, which is contained within an ultrasound probe 112, such as an external probe or an internal probe such as an intravascular ultrasound ("IVUS") catheter probe. In other examples, the transducer array 114 is in the form of a flexible array configured to conformally apply to the surface of the object to be imaged (e.g., a patient). The transducer array 114 is configured to transmit an ultrasound signal (e.g., a beam, wave) to a target area, such as the chest of a patient, and to receive an echo (e.g., a received ultrasound signal) corresponding to the ultrasound signal transmitted from the target area. Various transducer arrays, such as linear arrays, curved arrays, or phased arrays, can be used. For example, the transducer array 114 may include a two-dimensional array (as shown) of transducer elements capable of scanning in both the elevation and azimuth dimensions for 2D and / or 3D imaging. As is generally known, the axial direction is perpendicular to the plane of the array (in the case of a curved array, the axial direction spreads out in a fan shape), the azimuth direction is generally defined by the longitudinal dimension of the array, and the elevation direction is perpendicular to the azimuth direction.
[0016]
[0031] In some examples, the transducer array 114 is coupled to a microbeamformer 116, which is located within an ultrasonic probe 112 and controls the transmission and reception of signals by the transducer elements in the array 114. In some examples, the microbeamformer 116 controls the transmission and reception of signals by active elements in the array 114 (e.g., an active subset of elements in the array that define an active aperture at any given time).
[0017]
[0032] In some examples, the microbeamformer 116 is coupled, for example, by a probe cable or wirelessly, to a transmit / receive (T / R) switch 118, which switches between transmit and receive, protecting the main beamformer 122 from high-energy transmit signals. In some examples, for example, in a portable ultrasound system, the T / R switch 118 and other elements in the system may be contained within the ultrasound probe 112 rather than within the ultrasound system base housing the image processing electronics. The ultrasound system base typically includes software and hardware components, including circuits for signal processing and image data generation, and executable instructions for providing a user interface.
[0018]
[0033] The transmission of ultrasonic signals from the transducer array 114 under the control of the microbeamformer 116 is directed by a transmit controller 120, which can be coupled to a T / R switch 118 and the main beamformer 122. The transmit controller 120 controls the characteristics of the ultrasonic signal waveform transmitted by the transducer array 114, such as amplitude, phase, and / or polarity. The transmit controller 120 also controls the direction in which the beam is steered. The beam is steered straight forward from the transducer array 114 (perpendicular to the transducer array 114) or at different angles for a wider field of view. The transmit controller 120 is also coupled to a user interface 124 configured to receive user input. For example, the user can choose whether the transmit controller 120 operates the transducer array 114 in harmonic imaging mode, basic imaging mode, Doppler imaging mode, or a combination of imaging modes (e.g., interleaving different imaging modes). The user also selects interventional actions to be performed using image guidance provided by the system 100 within the user interface 124. In some examples, the user interface 124 includes one or more input devices, such as a control panel 125, which may include one or more mechanical controls (e.g., buttons, encoders, etc.), touch-sensitive controls (e.g., trackpads, touchscreens, etc.), and / or other known input devices that respond to various auditory and / or tactile inputs (e.g., voice command receivers).
[0019]
[0034] In some examples, the partially beamformed signal created by the microbeamformer 116 is coupled to the main beamformer 122, where the partially beamformed signals from individual patches of transducer elements are combined to form a fully beamformed signal. In some examples, the microbeamformer 116 can be omitted, and the transducer array 114 is under the control of the main beamformer 122, in which case the main beamformer 122 can perform all beamforming of the signal. With or without the microbeamformer 116 in the examples, the beamformed signal from the main beamformer 122 is coupled to a processing circuit 126, which includes one or more processors (e.g., an anatomical recognition processor 128, an image reconstruction processor 130, and one or more image generation and processing components 132) configured to create a live, reconstructed ultrasound image from the beamformed signal (e.g., beamformed RF data).
[0020]
[0035] The signal processor 134 receives beamformed RF data and processes the data using various techniques such as bandpass filtering, decimation, and separation of I and Q components. The processing of beamformed RF data performed by the signal processor 134 differs, at least in part, based on specific interventional procedures performed by the user. The image processor 136 is generally configured to generate image data from the RF data and performs additional enhancements such as speckle reduction, signal synthesis, spatial and temporal denoising, and contrast and intensity optimization. Radio frequency data acquired by the ultrasonic probe 112 is processed into various types of image data, non-limiting examples of which include channel-by-channel data, pre-beamformed data, post-beamformed data, log detection data, scan transformation data, and echo data processed in 2D and / or 3D.
[0021]
[0036] The processed signals (e.g., I and Q components) output from the signal processor 134 are coupled to additional downstream signal processing circuits for anatomical landmark detection, image reconstruction, and automated user guidance. For example, signals from the signal processor 134 can be transmitted to the anatomical recognition processor 128 and the image reconstruction processor 130, each of which is communicatively coupled to the user interface 124.
[0022]
[0037] The anatomical recognition processor 128 is configured to recognize various anatomical features within a set of image data. Embodiments of the anatomical recognition processor 128 are configured to recognize such features by referring to and classifying a large library of stored images. For example, the anatomical recognition processor 128 includes a cardiac recognition processor configured to identify one or more features of a patient's heart, such as atria, ventricles, valves, annulus, etc., by referring to and classifying a large library of cardiac images obtained from a sample of patients treated according to various interventional cardiac procedures. Over time, new images of additional features not originally included may be added to the library, and non-limiting examples include images of organs such as the brain, lungs, or liver, and parts thereof.
[0023]
[0038] The image reconstruction processor 130 receives image data output stored or buffered in the image memory 138 and uses the information collected by the recognition processor 128 to generate one or more 2D planar views of specific features of interest along a specific plane, for example, a planar view and / or at least one cross-sectional view related to an image-guided interventional procedure. Embodiments of the image reconstruction processor 130 are also configured to use acquired ultrasound data to generate one or more 3D volumetric views of specific features of interest from specific advantageous points related to an image-guided interventional procedure. The image reconstruction processor 130 thus reconstructs the image by working in conjunction with one or more additional processors included in the system 100.
[0024]
[0039] Two-dimensional image reconstruction involves slicing one or more planes present in the received volumetric image data set and reconstructing one or more new 2D images along those planes for display on the user interface 124. The image reconstruction processor 130 automatically creates desired planar views in response to the selection of a particular interventional procedure and / or in response to user input received on the user interface 124, either before or during an interventional procedure. For example, as will be described in more detail below, the image reconstruction processor 130 is configured to generate a top planar view and at least one cross-sectional side view of the mitral valve in response to the user selecting or inputting a valve clipping procedure on the user interface 124. Views necessary to guide the user through a particular interventional procedure are stored in the system so that at least one procedure-specific view is reconstructed when the user selects a procedure on the user interface 124 and sufficient volumetric ultrasound data has been received from the ultrasound probe 112. The reconstruction processor 130 generates the necessary views sequentially in the order required to perform the interventional procedure, or generates them all at once for simultaneous or sequential display on the user interface 124.
[0025]
[0040] In some cases, the image reconstruction processor 130 is unable to work with the anatomical recognition processor 128 to generate the desired view due to insufficient volume data acquired via the probe 112 and supplied to the signal processor 134. This occurs when the user fails to fully capture anatomical features such as the heart during the initial ultrasound data acquisition process. This situation prompts the anatomical recognition processor 128 and / or the image reconstruction processor 130 to generate an instruction to the system state controller 140 that insufficient ultrasound data has been captured and to communicate that instruction to the user interface 124 for display. In some embodiments, the instruction includes one or more commands that ask the anatomical recognition processor 128 to adjust the position, orientation, and / or settings of the ultrasound probe 112 in a manner necessary to acquire sufficient volume image data so that the anatomical recognition processor 128 can recognize the required landmarks and the image reconstruction processor 130 can generate images along clinically relevant planes.
[0026]
[0041] In some embodiments, the signals generated by the signal processor 134 are coupled to a scan converter 142 and / or a multiplanar reformatter 144. The scan converter 142 is configured to arrange the echo signals into the intended geometric format. For example, data collected by a linear array transducer may represent rectangles or trapezoids, while sector lobe data may represent sectors of circles.
[0027]
[0042] For example, as described in U.S. Patent No. 6,443,896 (Detmer), the multiplanar reformatter 144 can convert echoes received from a point in a common plane within a volume image of the body into an ultrasound image of that plane. In some examples, the scanning converter 142 and the multiplanar reformatter 144 are implemented as one or more processors.
[0028]
[0043] Embodiments configured to generate a clinically relevant volume subset of image data may include a volume renderer 146 configured to generate an image (also called projection, render, or rendering) of a 3D dataset viewed from a given reference point, as described, for example, in U.S. Patent No. 6,530,885 (Entrekin et al.). In some examples, the volume renderer 146 is implemented as one or more processors. The volume renderer 146 generates renderings, such as positive rendering or negative rendering, by any known or future known technique, such as surface rendering and maximum intensity rendering.
[0029]
[0044] The output from the image processor 136 (for example, a B-mode image along a specific image plane) is coupled to the local image memory 138 for buffering and / or temporary storage before being displayed on the image display 148 via the system state controller 140.
[0030]
[0045] The system status controller 140 generates graphic overlays for display along with the images. These graphic overlays include standard identification information such as patient name, date and time of image, and imaging parameters. For these purposes, the system status controller 140 is configured to receive inputs from the user interface 124, such as typed patient names or other annotations. The graphic overlays may also include information specific to the selected procedure, such as one or more image plane labels, anchor points, instructions or warnings received from other components of the system 100, or selectable user instructions for acquiring images along one or more image planes. For these purposes, the system status controller 140 is configured to receive inputs from the user interface 124 that include or relate to the selection of an interventional procedure and / or confirmation that one or more interventional steps have been successfully performed by the user, thereby prompting the system 100 to acquire additional images according to the next steps of the procedure. The user interface 124 can also be coupled to the multiplanar formatter 144 for the selection and control of the display of multiple multiplanar format (MPR) images.
[0031]
[0046] System 100 includes local memory 138. Local memory 138 is implemented as any suitable non-transient computer-readable medium (e.g., a flash drive, a disk drive). Local memory 138 stores data generated by System 100, including images, executable instructions, inputs provided by the user via the user interface 124, or any other information necessary for the operation of System 100.
[0032]
[0047] The user interface 124 includes a display 148 and a control panel 125. The display 148 includes a display device implemented using various known display technologies such as LCD, LED, OLED, or plasma display technology. In some examples, the display 148 comprises multiple displays. The control panel 125 is configured to receive user input (e.g., selection of interventional procedures, imaging mode, selection of regions of interest, image adjustments). The control panel 125 includes one or more hard controls (e.g., buttons, knobs, dials, encoders, mice, trackballs, etc.). In some examples, the control panel 125 includes, as an addition or alternative, soft controls (e.g., GUI control elements or simply GUI controls) provided on a touch-sensitive display, where these soft controls overlap with the display 148, allowing the user to directly interact with the image displayed on the display 148 by, for example, touch-selecting specific anatomical features to highlight and / or indicating the position or orientation of interventional devices implanted in such anatomical features. In some examples, the display 148 is a touch-sensitive display containing one or more soft controls of the control panel 125. The user interface 124 is also used to adjust various parameters of image acquisition, generation, and / or display. For example, the user adjusts power, imaging mode, gain level, dynamic range, spatial synthesis on and off, and / or smoothing level. In some embodiments, user-adjustable settings affect the imaging mode.
[0033]
[0048] In some embodiments, the various components shown in Figure 1 are combined. For example, the anatomical recognition processor 128, the image reconstruction processor 130, the image processor 136, and / or the system state controller 140 are implemented as a single processor. In some examples, the various components shown in Figure 1 are implemented as separate components. For example, the signal processor 134 is implemented in the form of a separate signal processor for each imaging mode (e.g., B-mode, color). In some examples, one or more of the various processors shown in Figure 1 are implemented by a general-purpose processor and / or microprocessor configured to perform the specified tasks described herein. In some examples, one or more of the various processors are implemented as application-specific circuits. In some examples, one or more of the various processors (e.g., the image processor 136) are implemented using one or more graphics processing units (GPUs). In other examples, one or more of the various processors (e.g., the signal processor 134) are implemented using one or more field-programmable gate arrays (FPGAs).
[0034]
[0049] Figure 2 is a block diagram showing an exemplary processor 200 according to the principles of this disclosure. The processor 200 is used to implement one or more processors described herein, for example, the image processor 136 shown in Figure 1. The processor 200 is any preferred processor type, including but not limited to a microprocessor, microcontroller, digital signal processor (DSP), field-programmable array (FPGA) programmed to form a processor, graphics processing processor, application-specific circuit (ASIC) designed to form a processor, or a combination thereof.
[0035]
[0050] The processor 200 includes one or more cores 202. Each core 202 includes one or more arithmetic logic units (ALUs) 804. In some examples, the core 202 includes, in addition to or instead of, the ALUs 204, a floating-point logic unit (FPLU) 206 and / or a digital signal processing unit (DSPU) 208.
[0036]
[0051] The processor 200 includes one or more registers 212 that are communicatively coupled to the core 202. The registers 212 are implemented using dedicated logic gate circuits (e.g., flip-flops) and / or any memory technology. In some examples, the registers 212 are implemented using static memory. The registers provide data, instructions, and addresses to the core 202.
[0037]
[0052] In some examples, the processor 200 includes one or more levels of cache memory 210 communicably coupled to the core 202. The cache memory 210 provides computer-readable instructions to the core 202 for execution. The cache memory 210 provides data for processing by the core 202. In some examples, the computer-readable instructions are provided to the cache memory 210 by local memory, for example, local memory attached to an external bus 216. The cache memory 210 is implemented using any preferred cache memory type, such as metal-oxide-semiconductor (MOS) memory such as static random-access memory (SRAM), dynamic random-access memory (DRAM), and / or any other preferred memory technology.
[0038]
[0053] The processor 200 includes a controller 214, which controls inputs to the processor 200 from other processors and / or components included in the system (e.g., user interface 124), and / or outputs from the processor 200 to other processors and / or components included in the system (e.g., display 148). The controller 214 controls the data paths in the ALU 204, FPLU 206, and / or DSPU 208. The controller 214 is implemented as one or more state machines, data paths, and / or dedicated control logic. The gates of the controller 214 are implemented as standalone gates, FPGAs, ASICs, or any other preferred technology.
[0039]
[0054] Registers 212 and cache memory 210 communicate with controller 214 and core 202 via internal connections 220A, 220B, 220C, and 220D. These internal connections are implemented as buses, multiplexers, crossbar switches, and / or any other suitable connection technology.
[0040]
[0055] The inputs and outputs of the processor 200 are provided via a bus 216 comprising one or more conductive wires. The bus 216 is communicatively coupled to one or more components of the processor 200, such as the controller 214, the cache 210, and / or the registers 212. The bus 216 is coupled to one or more components of the system, such as the aforementioned display 148 and control panel 125.
[0041]
[0056] Bus 216 is coupled to one or more external memories. The external memory includes read-only memory (ROM) 232. ROM 232 is masked ROM, electronically programmable read-only memory (EPROM), or any other preferred technology. The external memory includes random access memory (RAM) 233. RAM 233 is static RAM, battery-backed static RAM, dynamic RAM (DRAM), or any other preferred technology. The external memory includes electrically erasable programmable read-only memory (EEPROM) 235. The external memory includes flash memory 234. The external memory includes magnetic storage devices such as disk 236. In some examples, the external memory is contained in a system such as the ultrasound imaging system 100 shown in Figure 1, for example, local memory 138.
[0042]
[0057] Embodiments of the system disclosed herein are configured to selectively acquire only the ultrasound image data necessary to obtain enhanced images of target anatomical features from one or more clinically relevant views determined to understand the precise needs of the user performing the interventional procedure. Once an anatomical feature is identified within the acquired image data, the system is configured to "zero in" to that feature, thereby ceasing to acquire and / or process unnecessary image data from irrelevant anatomical regions. In this way, the system can improve the processing speed of the system while maintaining the volume frame rate, and at the same time improve the resolution and overall quality of the final reconstructed image.
[0043]
[0058] Figure 3 illustrates the system's efficiency improvements, depicting a first set of scan lines 302 and a second set of scan lines 304 necessary to create a 2D cross-sectional image of a target anatomical feature 306 through a clinically relevant imaging plane. Conventionally, to acquire volumetric image data from a region of interest 308 containing the anatomical feature 306, the ultrasound transducer sweeps a series of scan lines and scanning planes such as a scanning plane 310. However, according to embodiments disclosed herein, the ultrasound transducer is configured to selectively acquire only the image data necessary to obtain the image data required to reconstruct a clinically relevant view of the object 306 along the scan lines and scanning planes. By scanning only the relevant area of the volume under investigation, for example, the target area by scan lines 302 and 304, the density of scan lines and scanning planes can be significantly increased without reducing the volumetric image data acquisition speed. One consequence of this trade-off is improved spatial resolution of the ultrasound image reconstructed along the clinically relevant plane. This functionality improves the overall performance of the system by optimizing image resolution and quality, as well as reducing the computational load and improving processing speed and efficiency.
[0044]
[0059] In one embodiment of image quality improvement, the anatomical recognition processor determines the optimal scanning depth required to reconstruct the image along a desired plane. For example, if a user is looking for a top-plane view of the mitral valve, the user is not interested in anatomical features located far below the valve leaflets. In this situation, the anatomical recognition processor determines the maximum scanning depth required to capture the valve leaflets and signals the ultrasound acquisition component to adjust the pulse repetition frequency accordingly. Thus, features of interest can be prioritized by selecting those with higher priority on the display shown in the user interface. This selection increases the density of scan lines and scan planes targeting only the selected features so that an acceptable volume rate is maintained. In some embodiments, a controller (e.g., a transmit controller 120) is configured to cause the system's image data acquisition component (e.g., an ultrasound probe 112) to stop transmitting ultrasound signals except for those required to generate a planar ultrasound image along the relevant image plane.
[0045]
[0060] Figure 4 is a flowchart showing step 400 of several methods performed by embodiments of the disclosed system, along with some notable inputs received by the disclosed system. As illustrated, inputs received according to various embodiments include 3D ultrasound volume data 402, pre-treatment data 404, and treatment selection 406, one or more of which are entered by the user or received from a database storing patient-specific and / or treatment-specific information. Based on these inputs, the system can perform anatomical landmark detection (408), optimize an image scanning sequence (410), reconstruct at least one ultrasound image specific to both the selected treatment and the detected anatomical landmarks (412), and display it on the user interface (414). Furthermore, as illustrated, the 3D ultrasound volume data 402, pre-treatment data 404, and treatment selection 406 can also cause the user interface 414 to display user controls specific to such inputs. In various examples, a system performing one or more of the steps 400 of the method may be configured to generate and display planar images of one or more specific orientations of at least one anatomical feature related to the performance of an interventional medical procedure, based on the received inputs 402, 404, and 406, and landmark detection 408. Non-limiting examples of such anatomical features include one or more heart valves or valve leaflets, which may be selected by the user depending on the specific procedure to be performed, the specific medical instruments used, and / or the medical device to be implanted. Orientations of anatomical features that may similarly be selected by the user include, for example, a top planar view and / or a cross-sectional view. The user performing the interventional procedure then relies on the planar images generated by the system to perform the procedure, which includes inserting the medical device through, into, or in close proximity to the anatomical feature.Planar images are displayed sequentially to correspond to the steps included in the selected procedure, and in some examples, the user confirms via the user interface 414 that each step has been successfully performed before the next planar image is generated and displayed. Embodiments are also configured to display one or more graphics on the user interface 414, for example, the landing zone, insertion position, and / or fixation point of a medical device, to further guide the user during the interventional procedure.
[0046]
[0061] Figure 5 is a flowchart of an exemplary method 500 carried out in accordance with the principles of this disclosure. In some examples, method 500 is carried out by an ultrasonic imaging system, such as an ultrasonic imaging system 100.
[0047]
[0062] In block 502, the system (e.g., ultrasound imaging system 100) receives user selections for interventional medical procedures, some non-limiting examples of interventional medical procedures including, but not limited to, cardiovascular valve clipping, annuloplasty, or adnexec closure. Procedures are entered manually by the user in free text format, identified via a search tool, and / or selected from a pre-configured list of procedure selections organized as drop-down menus or buttons displayed on the user interface, for example. The user interface is also configured to display procedure-specific graphics and controls. For example, the user interface is configured to display graphics that allow the user to select one or more specific valves or leaflets to be targeted. The user interface is also configured to display selectable orientation options for a planar view of the target anatomical feature, along with one or more graphics that highlight the implantation zone or implantation site of the medical device, which are overlaid on the current image. In some examples, graphics showing medical device placement options may be adjusted by the user before or during the interventional procedure. For example, the user interface displays the landing zone of a medical implant along the circumference of the valve annulus. The user then adjusts the position of the landing zone based on various factors, such as newly discovered patient-specific anatomical structures and / or user experience. Such adjustments are entered into the user interface, and the user-modified landing zone is then displayed.
[0048]
[0063] In block 504, the system acquires and receives imaging data via an ultrasound transducer that examines a volume of interest, such as the chest region of a patient. As disclosed herein, the imaging data includes 3D ultrasound volume data.
[0049]
[0064] In block 506, the system automatically recognizes and / or identifies anatomical features in the imaging data related to the selected interventional procedure. If not recognized and / or identified, the system displays a graphic or other warning on the user interface indicating that the required anatomical features were not captured in the initial scan sequence. In some examples, the system also generates and displays commands to adjust the imaging device, such as an ultrasound probe, in the manner necessary to acquire the required image data.
[0050]
[0065] In block 508, the system uses information about the relative location of relevant anatomical features to the transducer and optimizes the scanning sequence accordingly to improve the image quality of the relevant anatomical structures. This step also improves the efficiency and speed of image acquisition and display.
[0051]
[0066] In block 510, the system continuously evaluates the suitability of the optimized scanning sequence using incoming imaging data and determines whether the scanning sequence needs to be updated. This may include acquiring imaging data by resampling the scanning area using an unoptimized scanning sequence.
[0052]
[0067] In block 512, the system can receive confirmation from the user that a particular interventional step has been successfully completed, for example, via manual or audible input received on the user interface. The user then specifies the next desired step, thereby restarting the process.
[0053]
[0068] Examples
[0069] The following embodiments should be interpreted as non-limiting examples illustrating how the disclosed systems and methods are implemented for specific interventional medical procedures. Therefore, the procedures, anatomical features, medical devices, and image graphics referenced below are provided for illustrative purposes only, and different procedures, anatomical features, medical devices, and image graphics may be selected and / or displayed in other embodiments. As described below, each procedure is associated with different relevant landmarks and image views necessary for user guidance, each of which involves changes in display created by the user interface.
[0054]
[0070] Example 1 - Valve clip treatment
[0071] Embodiments of the disclosed system are configured to guide the user through various cardiovascular valve clipping procedures, which often involve connecting two or more valve leaflets or commissures with an implantable clipping device. For example, mitral or tricuspid valve clipping procedures typically require obtaining and displaying at least two different views of the treatment site to provide the user with the necessary image guidance to accurately position the clip. In the case of mitral valve clipping procedures, the first view is a “top” plan view 600 of the mitral valve 602 shown in Figure 6. This plan view 600 is important for confirming the relative position of the valve clip 604 to the target valve leaflets and / or commissures when placing the clip 604 by an interventional device, including a catheter 606 in the illustrated example. It is also important to confirm that the orientation of the clip 604 is aligned perpendicular to the junction of interest. In the specific example shown in Figure 6, the mitral leaflets are clipped together at the A2 and P2 commissures, which can be confirmed using the top plan view 600. However, even with this view alone, it remains difficult for clinicians to determine whether the trajectory of clip 604 is correct.
[0055]
[0072] Therefore, a second important view typically includes a cross-sectional view 700 of the mitral valve 702, as shown in Figure 7. Obtaining this view 700 is necessary to ensure that the trajectories of the clip 704 and catheter 706 are perpendicular to the mitral valve leaflet surface plane when the valve is closed. If the imaging plane is not properly aligned with the trajectory of the interventional device during the insertion process, the clip 704 may be mispositioned, and inadvertently the clip 704 may catch on the valve commissure at a certain angle, putting pressure on the valve leaflet during each cardiac cycle. In addition, improper imaging leading to inappropriate clip placement may prevent the placement of the clip 704 due to interference from ligaments hidden from the imaging plane.
[0056]
[0073] To obtain the necessary images, the center of the transducer opening must be precisely positioned on the desired trajectory of the clip. Therefore, with manual ultrasonic transducer operation, obtaining clear images along the cross-section of valve 702, as shown in Figure 7, can be difficult. Positioning the transducer opening in this manner can be a time-consuming process, and achieving this becomes even more difficult in the case of tricuspid valve clipping procedures. Some existing techniques, such as systems configured to reconstruct 2D images from 3D datasets, eliminate the constraint of precise relative positioning of the transducer, but still require the user to manually acquire the image plane, a task that typically needs to be repeated each time the transducer moves relative to the anatomical structure.
[0057]
[0074] To reduce user difficulty, minimize errors, and shorten treatment duration, embodiments of the system disclosed herein may include an adaptive user interface configured to display selections for valve selection and clip placement to the user even before interventional procedures begin. For example, Figure 8 shows an exemplary display 800 including a tricuspid valve graphic 802 and a mitral valve graphic 804. Depending on the interventional procedure being performed, the user can select one of the displayed valve graphics, for example, via a touchscreen. Individual leaflets are also depicted on each valve graphic for the user to select. Specifically, the tricuspid valve graphic 802 includes a selectable posterior leaflet 806, a selectable anterior leaflet 808, and a selectable septal leaflet 810. The mitral valve graphic 804 includes a selectable posterior leaflet 812 and a selectable anterior leaflet 814.
[0058]
[0075] Once the valve and / or at least one valve leaflet is selected, volumetric ultrasound imaging of the body portion surrounding the selected valve (in this example, a portion of the patient's chest) is initiated. If the valve of interest is not captured within the volume scanned by the ultrasound transducer, one or more processors, for example, the anatomical recognition processor 128 and / or image reconstruction processor 130 shown in Figure 1, generate signals for display on the user interface, thereby prompting the user to adjust the position and / or orientation of the transducer.
[0059]
[0076] The user's selection of the valve and / or leaflets of interest prompts the anatomical recognition processor to also determine specific orientations of the annular plane, leaflet / comment surface plane, and junction plane, based on anatomical landmarks identified by the anatomical recognition processor within the volume data. The orientation of the leaflet surface plane is defined by the plane created by the surfaces of the leaflets joined according to the procedure, and in the case of the mitral valve, the surface of the commissure surface plane is defined by the surfaces of the commissures joined. The junction plane is defined as the plane formed by the joined portions of the junction. Once the required anatomical landmarks and at least one of the aforementioned orientations have been identified, the anatomical recognition processor automatically stops processing the remaining image data of the entire heart to reduce computational output.
[0060]
[0077] Next, the image reconstruction processor uses the acquired volume data and identified landmarks to generate a top-plane view showing the valve annular plane. The user can select a landing zone for placing the valve clip from this plane in the user interface. The image reconstruction processor then generates at least one additional image along a plane perpendicular to the top-plane view, such as the cross-sectional view shown in Figure 7. In some examples, the reconstruction processor generates two cross-sectional views rotated 90° relative to each other, with the axis of rotation perpendicular to the valve leaflet / compass surface plane and centered on the user-selected landing zone.
[0061]
[0078] After inserting the interventional device and providing the user with the necessary views to position the valve clip along the selected landing zone, the anatomical recognition processor may or may not continue to monitor the valve orientation along one or more of the aforementioned planes. Alternatively, the anatomical recognition processor may be ECG gate-controlled so that anatomical recognition and / or image reconstruction is performed only once per cardiac cycle during diastole when the mitral or tricuspid valve is closed. Embodiments may also be configured to respond to on-demand image analysis and reconstruction prompted by user input received at the interface, for example, if the patient and / or transducer move during the procedure.
[0062]
[0079] Figure 9 shows a flowchart of an exemplary valve clip procedure 900 performed according to at least one embodiment described herein. As illustrated, the procedure begins in step 902 with selecting a landing zone for the valve clip. This selection is received from the user, for example, via a user interface 124. In some examples, the landing zone selection is received via user interaction with an ultrasound image displayed on the user interface 124. For example, the user interface includes a touchscreen configured to display a landing zone graphic indicating the location, size, and / or anchor points of the landing zone in response to user input. The procedure proceeds to step 904, where full volume acquisition is performed with ECG gate control (e.g., via an ultrasound probe 112), and then in step 906, automatic detection of anatomical landmarks is triggered (e.g., via an anatomical recognition processor 128). The landmarks include and / or enable identification of the annular plane, leaflet / commissural plane, and junctional plane. Next, in step 908, volume image data acquisition is optimized by acquiring only the image data necessary to observe, for example, the annular plane, the leaflet / compression plane, and / or the junction plane. Then, in step 910, the image reconstruction processor automatically generates at least one view of the valve necessary for accurate valve clip placement, either in real time or at regular intervals. The required views include an annular view, a junction cross-section at 0°, and a junction cross-section at 90°.
[0063]
[0080] Example 2 - Valve ring formation procedure
[0081] The disclosed system embodiments may be configured to guide the annular formation procedure. For example, the Cardioband annuloplasty system (Edwards Lifesciences, Irvine, California) is a commercial valve reconstruction system featuring an implant (Cardioband) placed and fixed along the valve annulus. Once properly positioned and fixed, the implant contracts to reshape the annulus, reducing regurgitation. Typically, a combination of imaging guidance, including fluoroscopy and transesophageal echocardiography ("TEE"), is used to place the implant and adjust it until it is properly fitted around the annulus. One of the main challenges in placing this device is ensuring that all of the more than 16 anchors used to secure the implant to the annulus are correctly positioned.
[0064]
[0082] Image 1002 in Figure 10, showing anchoring in progress, illustrates the implant 1004 being released from the end of catheter 1006 at its target position around the annulus 1008. Each anchor 1010 used to fix implant 1004 may be positioned individually as the implant is gradually deployed from catheter 1006 by directly inserting each anchor into the annular tissue. As shown in post-implantation image 1012, the fixed implant surrounds a portion of the outer circumference of the annulus. Crucial to proper anchor placement is the relative trajectory of each anchor to the implant, the annulus, and other surrounding anatomical structures. For example, the trajectory of each anchor must be angled so that the implant can be attached to the annulus against the force vectors applied to the annulus throughout each cardiac cycle. Furthermore, each anchor must avoid striking important anatomical structures around the annulus, such as the aortic root and coronary arteries.
[0065]
[0083] To minimize the possibility that implant placement may be ineffective and / or unsafe, the automated image guidance provided by the system disclosed herein may be configured to automatically generate a top-plane view of the implant landing zone around the valve annulus, thereby improving anchor placement planning. The disclosed system may also be configured to automatically create a cross-sectional image plane for each anchor, thereby enabling precise anchor placement on an anchor-by-anchor basis.
[0066]
[0084] During operation, the user can select the valve of interest in the user interface (e.g., user interface 124) by interacting with a graphical display 1100, which includes a tricuspid valve graphic 1102 and a mitral valve graphic 1104, similar to those shown in Figure 11. Depending on which valve annulus is being targeted, i.e., the tricuspid annulus 1106 or the mitral annulus 1108, the user can select one of the displayed valve graphics, for example, via a touchscreen.
[0067]
[0085] Before, during, or after the selection of a specific valve annulus, the system can acquire volumetric image data using an ultrasonic transducer, as shown in Figure 12, for example, to generate a volumetric image 1200. Using the information selected by the user via the user interface and the volumetric image data acquired by the ultrasonic transducer, a landing zone 1202 can be rendered on the 3D image 1200 along with the contour of the valve leaflet hinge 1204. The displayed landing zone 1202 can be selected in the pre-procedure planning stage and then rendered on a live ultrasonic image during the annuloplasty procedure, and can be adjusted in real time by the user interacting with the user interface.
[0068]
[0086] The user can also select a specific anchor point within the landing zone 1202 by simply tapping the user interface at the target location within the displayed landing zone. During anchor placement, the user can further indicate in the user interface which anchor to place, prompting the system to automatically create two or more cross-sectional views at the anchor site. For example, as shown in volume image 1300 in Figure 13, the first cross-sectional view 1302 and the second vertical cross-sectional view 1304 intersect at anchor point 1306. This process may be repeated for each anchor to ensure that each anchor is fixed in the correct position (e.g., by a top plan view) and at the correct angle (e.g., by one or more cross-sectional views).
[0069]
[0087] To improve efficiency, the anatomical recognition processor discontinues continuous monitoring of plane orientation and instead operates at intervals, for example, once per cardiac cycle. The system also updates the user interface display in real time to show the plane associated with each anchor as anchors are placed according to a pre-planned procedure protocol. In some examples, optimized associated plane images are captured in real time, and the system may be configured to periodically re-determine the optimal image plane, such as once per cardiac cycle. In some embodiments, the system can respond to on-the-fly user input, for example, if anchor position needs to be corrected during operation. This function is performed in conjunction with stored procedure specifications or a pre-entered, customized procedure plan entered by the user. Thus, procedure plan information can be integrated with image data acquired in real time. Furthermore, after a given anchor has been successfully placed, the system can display the image plane required for the placement of the next anchor, thereby providing a guide for the user to follow. This display can also be adapted if there is an error between the pre-planned anchor point and the actual anchor point.
[0070]
[0088] Figure 14 shows a flowchart of an exemplary annuloplasty procedure 1400 performed according to at least one embodiment described herein. As illustrated, the procedure begins in step 1402 with the selection of the landing zones for the valve and annuloplasty implant via user input 1403 received at a user interface (e.g., user interface 124). The procedure proceeds to step 1404, in which full-volume ultrasound acquisition with ECG gate control is performed using an ultrasound probe (e.g., probe 112) under the direction of a controller (e.g., transmit controller 120) communicably coupled with, for example, at least one beamformer (e.g., microbeamformer 116 and / or beamformer 122) and a signal processor (e.g., processor 134), and then in step 1406, automatic detection of anatomical landmarks is triggered (e.g., via an anatomical recognition processor 128), and the step is also influenced by pre-procedure landing zone selection 1408. Landmarks identified in step 1406 include the annular plane, leaflet hinge point, and landing zone. Next, in step 1410, volumetric image data acquisition is optimized by instructing the ultrasound probe (e.g., probe 112) (e.g., via the transmit controller 120) to stop acquiring image data except for images required to generate an image along the relevant plane, and then in step 1412, the image reconstruction processor (e.g., processor 130) automatically reconstructs at least one view of the valve annulus necessary for implant placement. In step 1414, the system prompts the user to select the required implant anchor points, for example, via one or more graphics displayed on the user interface, using the views generated during step 1412 and displayed on the user interface, and then the system generates and displays a top valve annulus view necessary for anchor positioning, along with a cross-sectional view of the vertical landing zone necessary to ensure that each anchor is fixed at the appropriate angle.
[0071]
[0089] Example 3 - Left atrial appendage closure procedure
[0090] Embodiments of the disclosed system may be configured to guide left atrial appendage ("LAA") closure procedures. The objective of LAA closure is to isolate the adnexa from hemodynamic interaction with the rest of the atrium. Most LAA closure procedures typically require three pieces of crucial information: confirmation that there are no thrombi in the adnexa, confirmation that there are no lateral lobes in the adnexa, and the minimum and maximum diameters of the atrial neck.
[0072]
[0091] Sufficient 3D imaging is essential to assess the presence of thrombi or adnexal lateral lobes. Since the laryngeal aorta (LAA) is located near the right edge of the 3D image acquired from the midesophageal view, the user must manually manipulate the transducer tip using a standard 90° field of view ("FOV") image to properly capture the entire LAA. The ultrasound imaging mode benefits by allowing a higher maximum FOV, e.g., approximately 120°. Therefore, the user can shift the FOV to the right while maintaining 90°, rather than scanning at the maximum FOV to center the LAA in the image while maintaining a constant frame rate. This allows the user to grasp the entire LAA in three dimensions.
[0073]
[0092] Typically, sufficient image guidance is provided during device implantation by generating multiple 2D images of the laparoscopic artery (LAA) cross-section. For example, current standard protocols include evaluating the LAA at planar rotation angles of 0°, 45°, 90°, and 135°. Another useful set of views typically includes LAA cross-sections that provide the maximum and minimum neck diameters.
[0074]
[0093] Part of the challenges from the user's perspective in providing these views is the relative position of the LAA to the transducer tip. Unless the LAA is directly in front of the transducer tip, adjusting the planar rotation angle shortens the LAA's cross section, forcing the user to manipulate the transducer every time a new rotation angle is needed. Under these circumstances, it is extremely difficult to reliably find a cross-sectional view of the LAA that maximizes or minimizes the neck diameter.
[0075]
[0094] In view of these challenges, embodiments of the system disclosed herein may be configured to receive user input to select a left atrium closure procedure, for example, via a dropdown menu displayed on the user interface. After acquiring 3D ultrasound data including the left atrium, the anatomical recognition processor identifies the plane of the ostium. It also measures the diameter of the ostium and determines the minimum and maximum values. These measurements may be ECG-gated to appear at the end of systole. Neck diameter measurements are also automatically acquired.
[0076]
[0095] Next, the image reconstruction processor can process the received image data using identified landmarks to generate 2D image slices related to the LAA closure procedure. Such views include a maximum inlet plane perpendicular to the inlet plane and a minimum inlet plane perpendicular to the inlet plane.
[0077]
[0096] By using these views, the user can manually define the position of the neck, and the system can provide the minimum and maximum diameters of the neck. The system can also provide a mechanism for the user to fine-tune the measurement by manually adjusting the orientation of the neck plane. As previously mentioned, for the guidance portion, standard protocols often require 2D imaging plane rotation angles of 0°, 45°, 90°, and 135°, with the rotation performed on the normal axis of the transducer plane. However, these imaging planes are not ideal. According to the system disclosed herein, the same rotation angles can be provided, but the rotation is performed around an axis centered on the inlet. As long as the entire LAA is captured within a 3D volume, the system is configured to generate these rotation angle views compliant with existing protocols, regardless of the actual transducer orientation. Since the transducer orientation does not provide a useful reference point, the system allows the user to specify what the 0° point is via a user interface. For example, the 0° point can be defined as the transducer's "unprocessed" non-rotating plane, the maximum inlet plane, or the minimum inlet plane.
[0078]
[0097] In some embodiments, not all relevant views are displayed simultaneously on a single monitor. Instead, the user can select specific views to display via a user interface. Figure 15 shows the selectable options, and the figure illustrates one embodiment of a display (e.g., display 148) shown on a user interface (e.g., user interface 124). As an example, the user selects a desired view on the interface selection screen 1500, where the user selects the 0-degree transducer angle button 1502, the 45-degree transducer angle button 1504, the 90-degree transducer angle button 1506, and the 135-degree transducer angle button 1508 to obtain the desired view.
[0079]
[0098] Figure 16 shows a flowchart of an exemplary LAA closure procedure 1600 performed according to at least one embodiment described herein. As shown, the procedure begins in step 1602 with positioning a wide FOV centered on the LAA. The procedure proceeds to step 1604, in which, for example, ECG gate full volume acquisition is performed using an ultrasonic probe (e.g., probe 112) under the direction of a controller (e.g., transmit controller 120) communicably coupled with at least one beamformer (e.g., microbeamformer 116 and / or beamformer 122) and at least one signal processor (e.g., processor 134), and then in step 1606, automatic detection of anatomical landmarks (e.g., performed via anatomical recognition processor 128) is triggered. The landmarks include and / or enable identification of the LAA inlet. Next, in step 1608, volumetric image data acquisition is optimized by instructing the ultrasound probe (e.g., probe 112) (e.g., via the transmit controller 120) to stop acquiring image data except for the images required to generate an image along the relevant plane, in response to a user selection of one or more viewing angles; then, after the 0° plane is defined in step 1610, in step 1612, the image reconstruction processor (e.g., processor 130) automatically generates at least one view of the entry point for display on the user interface. The required views include LAA sections at 0°, LAA sections at 45°, LAA sections at 90°, and / or LAA sections at 135°, which are displayed simultaneously or sequentially as the procedure is being performed. In some examples, the user inputs confirmation on the user interface that one or more interventional steps have been performed, thereby causing one or more underlying processing components (e.g., image processor 136) to display subsequent planar images corresponding to the next steps of the interventional procedure on the interface display.
[0080]
[0099] Figure 17 is a flowchart of an exemplary method 1700 carried out according to various embodiments described herein. Method 1700 may be performed by an ultrasound imaging system, such as ultrasound imaging system 100. The steps of Method 1700 are performed in chronological order as shown or in any order. Therefore, the specific sequence of steps shown in Figure 17 should not be interpreted as limiting.
[0081]
[0100] In block 1702, the system receives user input indicating the selection of an interventional medical procedure. In some embodiments, the procedure includes cardiovascular clipping, annuloplasty, or left atrial appendage closure. As shown in block 1703, the system also receives instructions for the implantation site specific to the procedure. In some examples, the system receives instructions for the implantation site specific to the procedure after displaying a planar ultrasound image (see block 1710) and / or after displaying a second planar ultrasound image (see block 1714). In block 1704, the system acquires image data by transmitting an ultrasound signal in a target region and receiving echoes from the target region in response to the ultrasound signal. The system then automatically identifies anatomical landmarks in the image data in block 1706. In block 1708, the system automatically generates a planar ultrasound image along the image plane associated with the selected interventional medical procedure based on the anatomical landmarks identified in the image data. The planar ultrasound images are generated in real time, at intervals, or on a periodic basis, and as shown in block 1709, the system stops acquiring image data except for the image data required to generate the planar ultrasound images. In block 1710, the system displays a planar ultrasound image during an interventional medical procedure. As shown in block 1712, the system receives confirmation, for example via user input, that a step in the selected interventional medical procedure has been performed, and, as shown in block 1714, based on the confirmation, displays a second planar ultrasound image necessary to perform subsequent steps in the selected interventional medical procedure.
[0082]
[0101] In various examples where the components, systems, and / or methods are implemented using computer-based systems or programmable devices such as programmable logic, it should be understood that the above-described systems and methods may be implemented using any of the various known or later-developed programming languages, such as C, C++, C#, Java, and VHDL. Therefore, various storage media, such as magnetic computer disks, optical disks, and electronic memory, can be prepared, which may contain information that can instruct a device, such as a computer, to implement the above-described systems and / or methods. Once a suitable device can access the information and programs contained in the storage media, the storage media provides the information and programs to the device, thereby enabling the device to perform the functions of the systems and / or methods described herein. For example, if a computer disk containing suitable material such as source files, object files, and executable files is provided to a computer, the computer can receive the information, appropriately configure itself, and perform the functions of the various systems and methods outlined in the above figures and flowcharts in order to perform various functions. That is, the computer can receive various parts of the information relating to different elements of the above-described systems and / or methods from the disk, implement individual systems and / or methods, and coordinate the functions of the individual systems and / or methods described above.
[0083]
[0102] In view of this disclosure, it should be noted that the various methods and devices described herein may be implemented in hardware, software, and / or firmware. Furthermore, the various methods and parameters are included merely as examples and are not included in an restrictive sense. In view of this disclosure, those skilled in the art can implement these teachings in determining their own techniques and the necessary equipment that influences them, while remaining within the scope of the invention. One or more of the functions of the processors described herein may be implemented using application-specific integrated circuits (ASICs) or general-purpose processing circuits that are incorporated into fewer or a single processing unit (e.g., a CPU) and programmed to perform the functions described herein in response to execution instructions.
[0084]
[0103] While this system has been described with reference to an ultrasound imaging system, it is also envisioned that the system may be extended to other medical imaging systems in which one or more images are systematically acquired. Therefore, the system may be used, but is not limited to, to acquire and / or record imaging information related to the kidneys, testes, breasts, ovaries, uterus, thyroid, liver, lungs, musculoskeletal system, spleen, heart, arteries, and vascular system, as well as for other imaging applications related to ultrasound-guided interventions. Furthermore, the system may also include one or more programs to be used in conjunction with a conventional imaging system to provide the features and advantages of the system. Specific further advantages and features of the disclosure will become apparent to those skilled in the art by examining the disclosure or will be experienced by those using the novel systems and methods of the disclosure. Another advantage of the systems and methods is that conventional medical imaging systems can be easily upgraded to incorporate the features and advantages of the systems, devices, and methods.
[0085]
[0104] Naturally, it should be understood that any one of the examples, embodiments, or processes described herein may be combined with one or more other examples, embodiments, and / or processes, or may be separated and / or performed between separate devices or device parts in accordance with this system, device, and method.
[0086]
[0105] Finally, the above description is intended to be illustrative of the System and Method and should not be construed as limiting the appended claims to any particular example or group of examples. Therefore, while the System is described in particular detail with reference to illustrative examples, it should be understood that many modifications and alternative embodiments can be devised by those skilled in the art without departing from the broader intended purpose and scope of the System and Method described in the appended claims. Accordingly, the specification and drawings should be considered illustrative and not intended to limit the scope of the appended claims.
Claims
1. A user interface that receives user input indicating the selection of an interventional medical procedure, and is configured to display a procedure-specific graphic, user input selection items, and / or instructions for the procedure in response to the receipt of the selection of the interventional medical procedure; An ultrasonic probe that transmits an ultrasonic signal in a target area, receives an echo in response to the ultrasonic signal, and generates radio frequency (RF) data corresponding to the echo, An image processor that generates image data from the RF data, An anatomical recognition processor that receives the image data and identifies anatomical landmarks in the image data related to the selected interventional medical procedure, An image reconstruction processor that generates a planar ultrasound image along an image plane associated with a selected interventional medical procedure based on the anatomical landmarks identified in the image data, and is configured to generate the planar ultrasound image in response to user input being received at the user interface before or during the interventional medical procedure. An ultrasound imaging system comprising, wherein the user interface displays the planar ultrasound image during the interventional medical procedure.
2. The ultrasound imaging system according to claim 1, wherein the interventional medical procedure includes cardiovascular valve clipping, annuloplasty, or left atrial appendage closure.
3. The ultrasonic imaging system according to claim 1, wherein the image data includes 3D data acquired via volume imaging mode.
4. The ultrasound imaging system according to claim 1, wherein the user interface further receives instructions for a procedure-specific implantation location.
5. The ultrasound imaging system according to claim 1, wherein the image reconstruction processor generates at least two planar ultrasound images along at least two image planes related to a selected interventional medical procedure, based on the anatomical landmarks identified in the image data and the interventional devices necessary to perform the interventional medical procedure.
6. The ultrasound imaging system according to claim 5, wherein the user interface sequentially displays the at least two planar ultrasound images while the interventional medical procedure is being performed.
7. The ultrasound imaging system according to claim 1, further comprising a controller that stops transmitting ultrasound signals except for the ultrasound signals necessary to generate the planar ultrasound image along the image plane related to the selected interventional medical procedure.
8. The ultrasound imaging system according to claim 1, wherein the user interface further receives confirmation that a selected step in the interventional medical procedure has been performed.
9. The ultrasound imaging system according to claim 8, wherein the user interface further displays a second planar ultrasound image necessary to perform subsequent steps in the selected interventional medical procedure based on the confirmation.
10. The ultrasound imaging system according to claim 1, wherein the image reconstruction processor generates the planar ultrasound image in real time along the image plane related to the selected interventional medical procedure.
11. The ultrasound imaging system according to claim 1, wherein the image reconstruction processor optimizes the scanning sequence of the image plane related to the selected interventional medical procedure at certain intervals.
12. The ultrasound imaging system according to claim 1, wherein the anatomical recognition processor further generates an instruction that the image data is insufficient to identify the anatomical landmark.
13. A step of receiving user input indicating the selection of interventional medical procedures, In response to receiving the selection of the interventional medical procedure, the steps include displaying procedure-specific graphics, user input selection items, and / or instructions for the procedure on the user interface, The steps include: acquiring image data by transmitting an ultrasonic signal in a target region and receiving an echo from the target region in response to the ultrasonic signal; The steps include automatically identifying anatomical landmarks in the image data related to the selected interventional medical procedure, In response to the reception of user input via the user interface before or during the interventional medical procedure, the steps include: automatically generating a planar ultrasound image along the selected image plane associated with the interventional medical procedure based on the anatomical landmarks identified in the image data; The steps of displaying the planar ultrasound image during the interventional medical procedure and A computer program that causes a computer to execute something.
14. The computer program according to claim 13, wherein the interventional medical procedure includes a cardiovascular valve clipping procedure, annuloplasty procedure, or left atrial appendage closure procedure.
15. The computer program according to claim 13, further comprising the step of causing the computer to perform a step of receiving instructions for an implantation location specific to the procedure.
16. The computer program according to claim 13, further causing the computer to perform the step of stopping the acquisition of image data, except for the image data required to generate the planar ultrasound image along the image plane related to the selected interventional medical procedure.
17. The computer program according to claim 13, further causing the computer to perform a step of receiving confirmation that a selected step in the interventional medical procedure has been performed.
18. The computer program according to claim 17, further causing the computer to perform the step of displaying a second planar ultrasound image necessary to perform a subsequent step in the selected interventional medical procedure based on the confirmation.
19. The computer program according to claim 13, further causing the computer to perform the step of generating a planar ultrasound image in real time along the image plane related to the selected interventional medical procedure.
20. The computer program according to claim 13, further comprising the step of causing the computer to perform a step of optimizing the scanning sequence of the image plane associated with the selected interventional medical procedure at certain intervals.
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