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EP-4739219-A1 - SYSTEMS AND METHODS FOR TISSUE ANALYSIS AND VISUALIZATION

EP4739219A1EP 4739219 A1EP4739219 A1EP 4739219A1EP-4739219-A1

Abstract

The invention relates to methods, systems, and devices providing tissue analysis and visualization using contrast enhanced ultrasound.

Inventors

  • OFIR, Maximilian
  • HENNERSPERGER, Christoph

Assignees

  • Luma Vision Limited

Dates

Publication Date
20260513
Application Date
20240703

Claims (20)

  1. 1. A system for providing tissue analysis and visualization, the system comprising: a console comprising a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor to cause the console to: receive three-dimensional (3D) ultrasound image data from an imaging device, the 3D image data being associated with an anatomical region of interest including a targeted tissue site and perfusion of a contrast agent therewith before, during, and/or after an ablation procedure being performed thereon; and dynamically reconstruct multiple images from the 3D image data to provide a 3D visualization of the anatomical region of interest and targeted tissue site, based, at least in part, on analysis of perfusion of the contrast agent relative to vasculature associated at least with the targeted tissue site.
  2. 2. The system of claim 1, wherein the 3D ultrasound image data is real-time 3D ultrasound data.
  3. 3. The system of claim 1, wherein the 3D visualization comprises visualization of lesion formations in the targeted tissue site.
  4. 4. The system of claim 1, wherein the tissue comprises microvasculature associated with the targeted tissue site.
  5. 5. The system of claim 4, wherein the analysis comprises identifying perfusion characteristics in the microvasculature.
  6. 6. the system of claim 5, wherein a lesion formation is identified based on the perfusion characteristics.
  7. 7. The system of claim 5, wherein the console is configured to correlate perfusion characteristics within a given location of the microvasculature with physical characteristics of the microvasculature at said given location.
  8. 8. The system of claim 5, wherein the perfusion characteristics comprise a plurality of gradations of propagation and accumulation of contrast agent into a given location of microvasculature.
  9. 9. The system of claim 8, wherein: unobstructed propagation and accumulation of contrast agent into a given location of microvasculature is indicative of unaffected and otherwise healthy microvasculature; and lack of propagation and accumulation of contrast agent into a given location is indicative of damaged microvasculature.
  10. 10. The system of claim 9, wherein the damaged microvasculature is a result of ablation and the lack of propagation and accumulation of contrast agent into the given location is indicative of a portion of a lesion formation.
  11. 11. The system of claim 10, wherein the console is configured to characterize a lesion formation based, at least in part, on correlation of the perfusion characteristics with physical characteristics of a given location of the microvasculature.
  12. 12. The system of claim 11, wherein the physical characteristics are one or more of flow, microflow, and stiffness.
  13. 13. The system of claim 11, wherein characterization comprises providing a visual indication of at least one of an extent of the lesion formation, transmurality of the lesion formation, and continuity of an ablation path associated with the lesion formation.
  14. 14. The system of claim 11, wherein the console is configured to segment a given lesion formation into at least three different regions comprising a core region, a border region immediately adjacent to and surrounding the core region, and a periphery region immediately adjacent to and surrounding the border region.
  15. 15. The system of claim 14, wherein a core region of a lesion formation is associated with a complete, or near complete, lack of propagation and accumulation of contrast agent into a given location of the microvasculature and appears normal within a 3D ultrasound image.
  16. 16. The system of claim 14, wherein a border region of a lesion formation is associated with some propagation and accumulation of contrast agent into a given location of the microvasculature and presents a stronger backscatter signal within a 3D ultrasound image as compared to a backscatter signal associated with the core region.
  17. 17. The system of claim 14, wherein a periphery region of a lesion formation is associated with substantially unobstructed propagation and lack of accumulation of contrast agent into a given location of microvasculature and presents a weaker backscatter signal within a 3D ultrasound image as compared to backscatter signals associated with the border region a short time after injection.
  18. 18. The system of claim 17, wherein the console performs segmentation of a given lesion formation based, at least in part, on a segmentation algorithm.
  19. 19. The system of claim 18, wherein the segmentation algorithm comprises at least one of automatic thresholding, connected component analysis, and neural network-based segmentation.
  20. 20. The system of claim 1, wherein the contrast agent is injected into vasculature before and/or after performing one or more ablation procedures.

Description

SYSTEMS AND METHODS FOR TISSUE ANALYSIS AND VISUALIZATION Cross-Reference to Related Applications This application claims priority to, and the benefit of, U.S. Provisional Application No. 63/525,262, filed July 6, 2023, the content of which is incorporated by reference herein in its entirety. Field of the Invention The invention generally relates to ultrasound imaging, and, more particularly, to systems and devices for providing tissue analysis and visualization using contrast enhanced ultrasound. Background Ultrasound imaging is a medical imaging technique for imaging organs and soft tissues in a human body. An ultrasound image is produced based on the reflection of high-frequency sound waves off of body structures. The strength (amplitude) of the sound signal in conjunction with the time it takes for the wave to travel through the body provides the information necessary to produce the image. Ultrasound imaging can help a physician evaluate, diagnose and treat various medical conditions. When making a diagnosis based on an ultrasound examination, physicians must rely on adequate image quality, acquisition of proper views, and sufficient quantification of all relevant structures and flows. For example, catheter-based endovascular ultrasound imaging technology employed within the vasculature (e.g., intravascular ultrasound (IVUS) or intracardiac echocardiography (ICE)) is commonly performed with two-dimensional (2D)-ultrasound imaging. In IVUS/ICE imaging systems, an ultrasonic transducer assembly is attached to a distal end of a catheter. The catheter is carefully maneuvered through a patient's body to an area of interest, such as within a coronary artery (for the case of IVUS), or within the right atrium (for the case of ICE). The transducer assembly transmits ultrasound waves and receives echoes from those waves. The received echoes are then converted to electrical signals and transmitted to processing equipment, in which a resulting ultrasound image of the area of interest may be displayed. In typical ultrasound systems configured to visualize inner body regions, dynamic forces are often employed, resulting in a dynamic movement of the body regions over time. These dynamic forces and movements make it difficult to stabilize internal imaging devices and to generate consistent and accurate images if imaging of the structure cannot be enabled in realtime (e.g., >20 Hz). As a result, the captured images often lack the necessary quality required to prescribe appropriate treatment or therapy. Because of the dynamic forces and movements in play, internal real-time imaging is limited to small two-dimensional areas or limited three- dimensional volumetric regions respectively. For certain treatments, such as catheter ablation, accurately capturing a visual representation of the anatomy of interest is paramount for a successful procedure. Catheter ablation is a treatment in which energy is applied to cardiac tissue to create scars or lesions for preventing or interrupting the transmission of abnormal electrical signals. Catheter ablation forms an essential part of the management of cardiac arrhythmias, including supraventricular tachycardia (SVT), atrial flutter (AFL), atrial fibrillation (AF) and ventricular tachycardia (VT). The relatively low efficacy of AF treatment is likely due to limitations in mapping, incomplete understanding of the driving mechanisms of arrhythmia, and, most importantly, the inability to create transmural and durable lesions. Successful catheter ablation requires not only precise localization of the arrhythmogenic substrate, but complete and permanent elimination of that substrate without producing collateral injury. The ablation effect depends on a number of factors, including applied electrical power, quality of the electrical contact, local tissue properties, presence of blood flow close to the tissue surface, and the effect of irrigation. Because of the variability of these parameters, it may be difficult to obtain consistent results and understand ablation effects in tissue using current systems and methods for ablation. As a result, current ablation systems may be limited because of the difficulties and challenges in tissue analysis and imaging before and after an ablation procedure. Summary The present invention recognizes the limitations of current tissue analysis and visualization using ultrasound technology, namely the inability to image and analyze the transmurality and continuity of ablation paths. In particular, the invention provides systems and methods for real-time, contrast- enhanced ultrasound imaging of an anatomical region of interest that uses data related to changes in the microvasculature to provide improved tissue imaging. More specifically, the present invention utilizes three-dimensional (3D) and/or four-dimensional (4D) ultrasound images of the anatomy of interest, as opposed to 2D ultrasound imaging, to facilitate detection and visualization of the full