Systems and methods for calculating a projected lesion depth

Abstract

The invention relates to systems and methods for ultrasound imaging, and, more particularly, to systems and methods for calculating a projected lesion depth for achieving a transmural lesion.

Description

[0001] SYSTEMS AND METHODS FOR CALCULATING A PROJECTED LESION DEPTH

[0002] Cross-Reference to Related Applications

[0003] This application claims priority to, and the benefit of, U.S. Provisional Application No. 63 / 666,436, filed July 1, 2024, the content of which is incorporated by reference herein in its entirety.

[0004] Field of the Invention

[0005] The invention generally relates to ultrasound imaging, and, more particularly, to systems and methods for calculating a projected lesion depth for achieving a transmural lesion.

[0006] Background

[0007] Atrial fibrillation (AF) as well as other complex cardiac arrythmias such as atrial flutter (AFL) or ventricular tachycardia (VT) are defined through irregular heartbeats caused by chaotic electrical signals in the atrial or ventricular chambers of the heart. Currently, it is estimated that more than 33 million individuals worldwide have AF, which is associated with many adverse outcomes, including stroke, dementia, heart failure, impaired quality of life, and increased medical costs. AF increases the risk of stroke by an average of 5-fold, and AF-related strokes are more severe than those not related to AF. AF is linked with the development of dementia, and is linked with an increased risk of sudden death. AF causes a wide variety of symptoms, including fatigue and reduced exercise tolerance. Further, in the United States, AF accounts for more than 450,000 hospitalizations yearly, and is reported to increase annual health care costs by $8700 per patient, resulting in a $26 billion annual increase in U.S. health care costs.

[0008] Cardiac ablation is a common treatment approach for arrythmias, where specific regions within the heart are destroyed through ablation. In cardiac ablation, energy is applied to cardiac tissue to create scars or lesions for preventing or interrupting the transmission of abnormal electrical signals. Cardiac ablation forms an essential part of the management of cardiac arrhythmias, including supraventricular tachycardia, atrial flutter, atrial fibrillation, and ventricular tachycardia.

[0009] For cardiac ablation using an interventional intracardiac echocardiography (ICE) system, accurately capturing a visual representation of the anatomy of interest is paramount for a successful procedure. 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 to understand ablation effects in tissue using current systems and methods for ablation.

[0010] Notably, despite extensive utilization of imaging equipment and tools for ablation, as well as systems supporting the identification of electrically active regions of the heart, AF treatment still has a relatively low efficacy. 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. As a result, despite years of research and emergence of improved imaging technologies, the reliable creation of effective and permanent lesions remains challenging.

[0011] Summary

[0012] The present invention addresses the limitations of currently utilized strategies for AF treatment and the need for improved systems and methods for ablation procedures. In particular, because only lesions that are transmural will remain conduction blocking, the invention provides systems and methods for calculating a projected lesion depth for achieving a sufficiently transmural lesion. The invention provides additional information to clinicians using an interventional echography (ICE) system to achieve lesions that are sufficiently transmural, meaning tissue is ablated through the whole heart wall, to remain conduction blocking.

[0013] In exemplary embodiments, the invention provides systems and methods for measuring the heart wall thickness underneath an ablation electrode via an ICE system. This information is then combined with, for example, ablation parameters of the ablation electrode and the contact force of the ablation electrode with the heart wall, to calculate a projected lesion depth.

[0014] Systems and methods of the invention recognize the drawbacks and limitations of conventional methodologies. For example, using conventional systems and methods, it is not possible during an ablation procedure for the clinician to determine how deep into the heart wall and to what extent the lesion was created. Despite the extensive utilization of imaging equipment and tools for ablation, as well as systems supporting the identification of electrically active regions within the heart (e.g. electroanatomical mapping systems), conventional imaging systems do not allow a clinical user to understand the complex endocardial and myocardial anatomy live and in sufficient detail to provide a clinician with highly reliable anatomical and physiological feedback before, during, and after an ablation procedure. Accordingly, the systems and methods of the invention address this problem and provide for fast, accurate, and live calculation of a projected lesion depth, which provides lesion extent information to clinicians during the ablation procedure in order to avoid reinterventions.

[0015] Aspects of the invention provide systems for providing a projected ablation lesion depth which include a console configured to be operably associated with an ultrasound imaging device and exchange data therewith, wherein the console comprises a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor. The instructions executable by the processor cause the console to receive and analyze three- dimensional (3D) ultrasound image data from an ultrasound imaging device. The 3D ultrasound image data is associated with an anatomical region of interest in which an ablation catheter is positioned. The ablation catheter includes at least one electrode comprising an electrode tip. As discussed in more detail herein, in addition to single point by point catheters, different catheter configurations may be used such as multi-electrode catheters, (i.e. spline catheter, balloon catheter, etc.), and the like, may be used. The tip may refer to the tip of the electrode in the contact region. The tip of the electrode may be tip-like but also flat. Further, the console is operable to calculate a position and orientation of the ablation catheter and the electrode tip in relation to a targeted tissue within the anatomical region of interest, such that a distance of the electrode tip from the targeted tissue is calculated and a contact point of the electrode with the targeted tissue is determined based on the calculated distance.

[0016] In some embodiments, the instructions executable by the processor further cause the console to calculate, using the 3D ultrasound image data and the contact point, a measurement of thickness of the targeted tissue proximate to the electrode tip. The instructions executable by the processor further cause the console to calculate, using the targeted tissue thickness measurement, a Tailored Ablation Index (TAI) value for a projected ablation lesion depth, in some embodiments. Further, the TAI value is calculated using the tissue thickness measurement and one or more ablation catheter parameters. For example, the one or more ablation catheter parameters comprises one or more of power (P), time (d), and contact force (DF) of the ablation electrode, in some embodiments.

[0017] In some embodiments, calculating a position and orientation of the ablation catheter comprises receiving data from one or more positional sensors.

[0018] In some embodiments, the 3D ultrasound image data comprises 3D image data obtained from an intracardiac echography (ICE) catheter.

[0019] In some embodiments, the console is further operable to run, via the console, one or more imaging algorithms configured to analyze the 3D ultrasound image data and identify one or more anatomical structures of interest, wherein at least one algorithm comprises a segmentation algorithm. For example, the one or more imaging algorithms are configured to calculate the position and orientation of the ablation catheter relative to a targeted tissue within a heart anatomy such that an exact position of the ablation catheter and the electrode tip relative to the targeted tissue is identified, in some embodiments. In some embodiments, a distance from a heart wall is measured from the electrode tip, wherein the tissue thickness measurement is a cardiac wall thickness measurement. Further, the cardiac wall thickness measurement is combined with a regression formula to calculate the projected lesion depth, in some embodiments.

[0020] In some embodiments, the processor further causes the console to determine, during an ablation procedure, whether a created lesion depth is sufficient to treat a condition. In which case, determining whether a created lesion depth is sufficient comprises applying one or more thresholds to the calculated TAI value, wherein the one or more thresholds vary between anatomical regions in the heart, in some embodiments. For example, the anatomical regions of the heart are identified and the TAI threshold is automatically provided via the one or more algorithms, in some embodiments. In further embodiments, the console is configured to output, via a display, visualization of the anatomical region of interest as a 3D model, wherein the output includes visualization of the identified position of the ablation catheter tip within the anatomical region of interest. In particular, the output provides feedback to a user as one or more of a guidance to achieve the contact point of the electrode tip with the targeted tissue, a distance from the electrode tip to the targeted tissue, and / or the sufficiency of the created lesion depth, in some embodiments. In further embodiments, the sufficiency of the created lesion depth comprises an indicator configured to indicate that the created lesion depth is sufficiently transmural. For example, the indicator comprises one or more of a color, a shape, a texture, and a shading configured to indicate that the created lesion depth is sufficiently transmural, in some embodiments.

[0021] In some embodiments, the console processor is configured to receive the 3D image data in real-time or near real-time from a field-of-view sufficient to capture the anatomical region of interest and to reconstruct the 3D image in real-time or near real-time.

[0022] In some embodiments, the electrode comprises one or more of one or more splines with one or more distinct electrodes, a spline electrode on a basket catheter, and one or more single electrodes on a point by point catheter.

[0023] In other aspects, the invention provides methods for providing a projected ablation lesion depth. The method includes the steps of providing a console configured to be operably associated with an ultrasound imaging device and exchange data therewith; receiving and analyzing, via the console, three-dimensional (3D) ultrasound image data from an ultrasound imaging device, the 3D ultrasound image data being associated with an anatomical region of interest in which an ablation catheter is positioned, said ablation catheter comprising at least one electrode comprising an electrode tip; and calculating a position and orientation of the ablation catheter and the electrode tip in relation to a targeted tissue within the anatomical region of interest, whereby a distance of the electrode tip from the targeted tissue is calculated and a contact point of the electrode with the targeted tissue is determined based on said calculated distance.

[0024] In some embodiments, the method includes calculating, using the 3D ultrasound image data and the contact point, a measurement of thickness of the targeted tissue proximate to the electrode tip. Further, in some embodiments, the method includes calculating, using the targeted tissue thickness measurement, a Tailored Ablation Index (TAI) value for a projected ablation lesion depth.

[0025] In some embodiments of the method, calculating a position and orientation of the ablation catheter comprises receiving data from one or more positional sensors.

[0026] In some embodiments of the method, the 3D ultrasound image data comprises 3D image data obtained from an intracardiac echography (ICE) catheter. For example, in some embodiments, the TAI is calculated using the tissue thickness measurement and one or more ablation catheter parameters. In which case, in some embodiments of the method the one or more ablation catheter parameters comprise one or more of power (P), time (d), and contact force (DF) of the ablation electrode.

[0027] In some embodiments of the method, analyzing the 3D ultrasound image data comprises running, via the console, one or more imaging algorithms configured to identify one or more anatomical structures of interest, wherein at least one algorithm comprises a segmentation algorithm. For example, the one or more imaging algorithms are configured to calculate the position and orientation of the ablation catheter relative to a targeted tissue within a heart anatomy such that an exact position of the ablation catheter and the electrode tip relative to the targeted tissue is identified, in some embodiments.

[0028] In some embodiments of the method, a distance from a heart wall is measured from the electrode tip, wherein the tissue thickness measurement is a cardiac wall thickness measurement. In particular embodiments, the cardiac wall thickness measurement is combined with a regression formula to calculate the projected lesion depth. In example embodiments, the method further comprises determining, during an ablation procedure, whether a created lesion depth is sufficient. For example, determining whether a created lesion depth is sufficient comprises applying one or more thresholds to the calculated TAI value, wherein the one or more thresholds vary between anatomical regions in the heart, in some embodiments. Further, the anatomical regions in the heart are identified and the TAI threshold is automatically provided via the one or more algorithms, in some embodiments.

[0029] In some embodiments, the method further comprises displaying a visualization of the anatomical region of interest as a 3D model, wherein the visualization includes the identified position of the ablation catheter tip within the anatomical region of interest. In particular embodiments, the output provides feedback to a user as one or more of a guidance to achieve the contact point of the electrode tip with the targeted tissue, a distance from the electrode tip to the targeted tissue, and / or the sufficiency of the created lesion depth. For example, in some embodiments of the method, the sufficiency of the created lesion depth comprises an indicator configured to indicate that the created lesion depth is sufficiently transmural. Further, the indicator comprises one or more of a color, a shape, a texture, and a shading configured to indicate that the created lesion depth is sufficiently transmural, in some embodiments. In some embodiments of the method, the console is configured to receive the 3D image data in real-time or near real-time from a field-of-view sufficient to capture the anatomical region of interest and to reconstruct the 3D image in real-time or near real-time.

[0030] In some embodiments of the method the electrode comprises one or more of a one or more splines with one or more distinct electrodes, one or more splines on a basket catheter, and one or more single electrodes on a point by point catheter.

[0031] Brief Description of the Drawings

[0032] FIG. 1 illustrates cardiac anatomy, viewed from an anterior perspective, relevant to catheter ablation for treatment of AF and other atrial arrhythmias.

[0033] FIG. 2A and FIG. 2B are diagrammatic illustrations of an ultrasound system according to one embodiment of the invention.

[0034] FIG. 3 is a perspective view of an imaging catheter with which systems of the invention may be coupled.

[0035] FIG. 4 illustrates a block diagram of a method for providing a projected ablation lesion depth according to one embodiment of the invention.

[0036] Detailed Description

[0037] The present invention recognizes the limitations of currently utilized strategies for atrial fibrillation (AF) treatment and the need for improved systems and methods for ablation procedures. In particular, the systems and methods of the invention provide for real-time calculation of a projected lesion depth. In exemplary embodiments, the systems and methods of the invention provide for calculating a projected lesion depth for clinicians using an interventional echography (ICE) system to achieve lesions that are sufficiently transmural to remain conduction blocking. For example, the systems and methods of the invention provide for measuring the heart wall thickness underneath an ablation electrode via an ICE system, which is then combined with other variables such as ablation parameters of the ablation electrode and the contact force of the ablation electrode with the heart wall, to calculate a projected lesion depth.

[0038] During an ablation procedure applied for treatment of cardiac arrhythmias it is required that thermal or electroporation-based lesion generation lead to electrical conduction blocks in the myocardium. Applied at appropriate locations, this procedure solves arrythmias and the patient’s heart returns to normal sinus triggered rhythm. However, only lesions that are sufficiently transmural — meaning tissue is ablated through the whole heart wall — will remain conduction blocking. If a lesion is not sufficiently transmural further ablation interventions may be necessary within as little as 3 to 12 months. Using conventional systems and methods, it is not possible during an ablation procedure for the clinician to determine how deep into the heart wall and to what extent the lesion was created. Despite the extensive utilization of imaging equipment and tools for ablation, as well as systems supporting the identification of electrically active regions within the heart (e.g. electroanatomical mapping systems), conventional imaging systems do not allow a clinical user to understand the complex endocardial and myocardial anatomy live and in sufficient detail to provide a clinician with highly reliable anatomical and physiological feedback before, during, and after an ablation procedure. Accordingly, the systems and methods of the invention address this problem and provide for fast, accurate, and live calculation of a projected lesion depth, which provides lesion extent information to clinicians during the ablation procedure in order to avoid reinterventions.

[0039] Overview

[0040] The invention provides systems and methods for automated, real-time calculation of a projected lesion depth, before or during an ablation procedure, to achieve sufficient lesion transmurality.

[0041] FIG. 1 illustrates cardiac anatomy, viewed from an anterior perspective, relevant to catheter ablation for treatment of AF and other atrial arrhythmias. The right atrium (RA) is right and anterior, while the left atrium (LA) is situated to the left and mainly posteriorly, with the right pulmonary veins adjacent to the intercaval area of the right atrium. Consequently, the plane of the atrial septum lies at an angle to the sagittal plane of the body. The front of the left atrium and the medial wall of the right atrium lie just behind the aortic root, separated only by the transverse pericardial sinus. The posterior wall of the left atrium is just in front of the tracheal bifurcation and the esophagus, with the fibrous pericardium separating the heart from these structures.

[0042] The systems and methods of the invention recognize that pulmonary vein anatomy is highly variable between patients. As disclosed herein, the present invention recognizes that, while individual pulmonary vein anatomy influences the recurrence of atrial fibrillation after catheter ablation, there is currently no single intraoperative imaging navigation technique to provide a clinician with highly reliable anatomical and physiological feedback, despite the number of intraoperative imaging modalities available. The invention provides systems and methods for measuring cardiac wall thickness using, for example, an ICE ultrasound system for transmural lesion calculations and applying a calculated tailored ablation index (TAI). Thus, the present invention provides systems and methods for individual tailoring of interruption of potential reentrant pathways.

[0043] Atrial fibrillation (AF) is a common supraventricular arrhythmia that is characterized by rapid and irregular activation in the atria. Atrial fibrillation, as well as other complex cardiac arrythmias such as atrial flutter or ventricular tachycardia, is defined through irregular heartbeats caused by chaotic electrical signals in atrial or ventricular chambers of the heart. AF is associated with many adverse outcomes, including stroke, dementia, heart failure, increased medical costs, impaired quality of life, and mortality. Paroxysmal AF (PAF) is defined as AF that terminates spontaneously or with intervention within 7 days of onset; persistent AF is defined as continuous AF that is sustained beyond 7 days; and long-standing persistent AF is defined as continuous AF of greater than 12 months’ duration. Silent AF is defined as asymptomatic AF diagnosed by an opportune ECG or rhythm strip. Paroxysmal, persistent, and long-standing persistent AF can be silent.

[0044] The pathophysiology of AF is complex, involving interaction among multiple factors, including triggers, which are responsible for AF initiation; substrate, which is necessary for AF maintenance; and perpetuators, which underlie the progression of the arrhythmia from paroxysmal to the persistent forms. For example, diverse factors contributing to the pathophysiology of AF include oxidative stress, calcium overload, atrial dilatation, microRNAs, inflammation, and myofibroblast activation. The central mechanisms governing AF initiation and perpetuation are poorly understood, which explains in part why treatment of patients with all forms of AF, and particularly long-standing persistent AF, remains suboptimal.

[0045] Catheter ablation of atrial fibrillation (AF) is a common yet highly complex procedure for the treatment of arrhythmias. Ablative therapy is aimed at either eliminating the trigger initiating AF or modifying the arrhythmogenic substrate. 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. In catheter ablation, specific regions within the heart are destroyed resulting in electrical isolation of these regions to prevent a propagation of electrical signals causing the arrhythmia. The most commonly employed ablation strategy consists of electrical isolation of the pulmonary veins by creation of circumferential lesions around the right and the left pulmonary vein. During an ablation procedure applied for treatment of cardiac arrhythmias it is required that thermal or electroporation-based lesion generation lead to electrical conduction blocks in the myocardium. Applied at appropriate locations, this procedure solves arrythmias and the patient’s heart returns to normal sinus triggered rhythm

[0046] As discussed herein, the likelihood of obtaining permanent electrical isolation is related to the quality of ablation energy delivery and lesion formation. There are many factors that play a role in determination of lesion transmurality. With RF energy common variables that impact transmurality include lesion size, catheter stability, contact force, power output, temperature, and duration of RF output. The invention addresses these factors and provides novel systems and methods for calculating a projected lesion depth.

[0047] Ultrasound imaging system

[0048] As is generally understood, ultrasound imaging (sonography) uses high-frequency sound waves to view inside the body. Because ultrasound images are captured in real-time, these images can also show movement of the body's internal organs as well as fluid flow (e.g., blood flowing through blood vessels). The imaging device (i.e. the transducer, probe, or transducer probe) is placed inside a body opening (e.g. endovascular ultrasound, intravascular ultrasound, intracardiac echocardiography). The final quality of the image obtained through ultrasound scanning is limited to the technical specifications of the equipment, the propagation of ultrasonic waves through the tissue analyzed, and the method used to reconstruct the images.

[0049] Systems of the invention may be operably connected with an ultrasound system with certain hardware and software for providing image reconstruction and imaging assembly control, for example as described in International PCT Application No. PCT / IB2019 / 000963 (Published as WO 2020 / 044117) to Hennersperger et al., U.S. Application Publication No. US 2022- 0287679A1 to Hennersperger et al., and U.S. Patent No. 11,382,599 to Hennersperger et al., the contents of each which are incorporated by reference herein. The data may be processed using imaging protocols to extract anatomical and functional information, and tissue characteristics as disclosed in more detail herein, and as disclosed in International PCT Application No. PCT / IB2019 / 000963 (Published as WO 2020 / 044117) to Hennersperger et al., U.S. Application Publication No. US 2022-0287679A1 to Hennersperger et al., and U.S. Patent No. 1 1,382,599 to Hennersperger et al., the contents of each which are incorporated by reference herein.

[0050] The systems include a console configured to be operably associated with one or more devices such as an ultrasound imaging device and to exchange data therewith. The console may comprise a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor to cause the console to receive data associated with a complex anatomy. For example, the console may be operable to receive a plurality of data, process and combine the data, and reconstruct, based on the processing and combining of the data, an interactive digital model of an imaged anatomy. In some embodiments, the complex anatomy may be cardiac and / or vascular anatomy. In some embodiments, the data comprises both catheter-based ultrasound imaging data and pulse phase data. Thus, the instructions executable by the processor may cause the console to receive data associated with at least one of cardiac and vascular anatomy the data comprising catheter-based ultrasound imaging data, and, in some embodiments, pulse phase data and / or 3D position data.

[0051] The console may be in active communication with a computing system configured to communicate across a network. The computing system or computing device may include one or more processors and memory, as well as an input / output mechanism (i.e., a keyboard, knobs, scroll wheels, or the like) with which a user can interact so as to operate the console, including making adjustments to the ultrasound imaging system, segmentation, saving images, initialization, continuous 3D image registration, filtering, optimization, 3D fusion, and panoramic image reconstruction.

[0052] The console may generally include one or more processors (e.g., a central processing unit (CPU), a graphics processing unit (GPU), or both) and storage, such as main memory, static memory, or a combination of both, which communicate with each other via a bus or the like. The memory according to embodiments of the invention can include a machine-readable medium on which may be stored one or more sets of instructions (e.g., software) embodying any one or more of the methodologies or functions described herein. The software may also reside, completely or at least partially, within the main memory and / or within the processor during execution thereof by the computer system, the main memory and the processor also constituting machine-readable media. The software may further be transmitted or received over a network via the network interface device. During operation, the CPU and / or GPU may control the transmission and receipt of electrical currents, subsequently controlling the emission and receipt of sound waves from the probe. The CPU and / or GPU may also analyze electrical pulses that the probe makes in response to reflected waves coming back and convert this data into images (i.e., ultrasound images) that can then be viewed on a display, which may be an integrated monitor. Such images may also be stored in memory and / or printed via a printer.

[0053] Systems of the invention are configured to receive three-dimensional (3D) ultrasound image data from an imaging device. In some embodiments, the invention provides for reconstruction of a patient-specific anatomical model for use in minimally invasive procedures in the vasculature. Accordingly, ultrafast ultrasound imaging techniques, such as planewave or diverging wave imaging, may be required to enable imaging within the constraints of the application, particularly for intravascular and / or intracardiac tissue assessment and analysis. These constraints could be posed due to the high temporal update rate as required for effects observed in visualization and tissue characterization, where plane and diverging wave methods enable high imaging rates, commonly also referred to ultrafast imaging approaches. Systems and methods of the invention allow for the direct utilization of all native ultrafast imaging techniques.

[0054] For example, for intracardiac imaging, planewave imaging may refer to an ultrasound imaging modality where, through a flat transmit of all transducer elements (at different angles) from the angular imaging aperture, a plane wave front may traverse the tissue and may be partially scattered back to the transducer. From the received radio frequency (RF) (i.e. channel) data the overall image may be reconstructed at once in parallel by dynamically beamforming the received RF data for each target position.

[0055] Ultrafast ultrasound methods offer imaging at thousands of frames per second limited only by the physical propagation speed of sound waves in tissue, and enable ultrasensitive bloodflow tracking, shear-wave imaging, super-resolution imaging, and other applications. For example, achieving optimal spatial resolution while enabling artifact-free imaging of dynamic cardiac structures requires a careful balance between spatial sampling and volumetric update rate which can only be achieved using ultrafast imaging techniques. Thus, the three-dimensional (3D) ultrasound image data received by systems of the invention may be real-time 3D ultrasound data. For example, the data may be full circumferential, 3D image data. While exemplary embodiments describe ultrasound imaging data received from 3D ICE catheters, catheter-based ultrasound imaging as described herein is not limiting. Imaging data may be received from catheter-based ultrasound systems that may include endovascular and / or intravascular ultrasound for in-body applications. This may include systems and imaging data for imaging in large cavities of the heart, coronary and peripheral arteries, as well as other organs such as liver, kidney, and the like. Systems and methods of the invention may be configured to receive information on ablation electrodes. Different catheter configurations may be used with systems of the invention. In non-limiting examples, the catheter may include single electrodes on a point by point catheter, a multi-electrode catheter (i.e. spline catheter, balloon catheter, etc.), spline electrodes on basket catheters, one or more splines with one or more distinct electrodes, and the like. In non-limiting examples, the tip of the electrode may refer to the tip of the electrode in the contact region. The tip of the electrode may be tip-like but also flat., e g. spline electrodes on basket catheters, or single electrodes on a point by point catheter.

[0056] FIG. 2A and FIG. 2B are diagrammatic illustrations of an exemplary ultrasound system 100 for providing catheter-based ultrasound imaging data specific to a patient 12. The system 100 may include an imaging device equipped with an imaging assembly 104 and a console 106 to which the imaging device is to be connected. The imaging device may be an imaging catheter

[0057] 102. Accordingly, systems and methods for interactive reconstruction of patient-specific digital model of cardiac and / or vascular anatomy may use a four-dimensional (4D) Intracardiac echocardiogram (ICE) system that captures the anatomy of interest.

[0058] As disclosed in detail herein, the imaging device may generally be in the form of an imaging catheter capable of providing imaging and mapping capabilities. Accordingly, such a device may be useful for ultrasound visualization of intravascular and / or intracardiac tissue, which may be particularly useful for catheter-based interventional procedures for assessing the anatomy as well as functional data in relation to a target volume of interest.

[0059] FIG. 3 is a perspective view of an imaging catheter 102 with which systems of the invention may be coupled. The catheter 102 may include a catheter body 108, including proximal and distal portions. The imaging assembly 104 may be provided at the distal portion

[0060] 103, for example, generally defining a distal end of an imaging catheter. A handle 110 may be operably associated with the catheter body 108 and allow for an operator (i.e., surgeon or other medical professional) to manipulate and advance the imaging assembly 104 and the catheter body 108 to a desired target site within the patient’s vasculature. The handle 1 10 may include user-operable inputs for controlling various features and functions of the imaging assembly 104. An interface member 112 may be provided at a proximal portion of the catheter body 108. The interface member 112 generally provides a connection between the imaging catheter 102, including the imaging assembly 104 and handle 110, and the console 106 for transmission of signals therebetween. The connection may include at least one of a hardwired and wireless connection, for example.

[0061] As generally understood, the systems and methods of the present invention may be used for ultrasound visualization of tissue of any kind with respect to any kind of procedure in which imaging analysis is used and / or preferred. The imaging device may be useful in carrying out catheter ablation to treat a cardiac condition, such as atrial fibrillation (AF) or the like. For example, in some embodiments, the catheter may include components providing associated capabilities. For example, portions of the catheter may include sensors (e.g., localization and / or tracking sensors) and / or energy delivery elements (e.g., ablation elements).

[0062] The imaging catheter may include a fully rotatable transducer unit comprised of an ultrasound transducer array configured to transmit ultrasound pulses to, and receive echoes of the ultrasound pulses from, surrounding intravascular tissue during a procedure. Such ultrasound transmissions result in a collection of image data which is received by the console and subsequently reconstructed into one or more images providing visualization and characterization of the surrounding intravascular tissue. In particular, the console may utilize image data received from an imaging assembly of the imaging catheter to reconstruct one or more images, including at least 2D and 3D images of the anatomical region of interest (i.e., intravascular and / or intracardiac tissue).

[0063] As discussed in more detail herein, the console may process the received image data utilizing certain imaging protocols and algorithms for reconstructing images and subsequently outputting, via a display, the reconstructed images to an operator depicting visualization of the anatomical region of interest. In addition to providing reconstruction of images based on received image data from the imaging assembly, the console may further provide control over the imaging assembly, including control over the emission of ultrasound pulses therefrom (intensity, frequency, duration, etc.) as well as control over the movement of the ultrasound transducer unit (i.e., controlling rotation, including speed and duration of rotation). Systems for calculating a projected lesion depth

[0064] Systems of the invention provide automatic, robust, fast, and accurate wall thickness measurement from ultrasound imaging data, for example, ICE image data, received from an ultrasound imaging system, and further use this data to calculate a projected lesion depth. In exemplary embodiments, systems of the invention receive ICE image data from an ICE system to calculate a wall thickness measurement, which is then combined with ablation parameters of the ablation generator, as well as other parameters to calculate, in real-time, a projected lesion depth.

[0065] Aspects of the invention provide systems for providing a projected ablation lesion depth. The systems may include a console configured to be operably associated with an ultrasound imaging device and to exchange data therewith. The console may include a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor such that the instructions cause the console to receive and analyze three-dimensional (3D) ultrasound image data from an ultrasound imaging device. The 3D ultrasound image data may be associated with an anatomical region of interest in which an ablation catheter may be positioned. Further, the instructions cause the console to calculate a position and orientation of the ablation catheter and an electrode tip of the catheter in relation to a targeted tissue within the anatomical region of interest, such that a distance of the electrode tip from the targeted tissue may be calculated and a contact point of the electrode with the targeted tissue may be determined based on said calculated distance.

[0066] Systems of the invention provide additional information to the clinician through measuring, via ultrasound, the heart wall thickness underneath an ablation electrode. In particular, an interventional intracardiac echography system (ICE) may be used to provide 3D ultrasound image data of an anatomical area of interest or target region.

[0067] The instructions executable by the processor may further cause the console to calculate, using the 3D ultrasound image data and the contact point a contact point of the electrode with the targeted tissue, and a measurement of thickness of the targeted tissue proximate to or beneath the electrode tip.

[0068] Measured tissue wall thickness The systems of the invention provide for measuring wall thickness at the location where the catheter is applying energy to the tissue to generate a lesion. Without this real-time or near real-time information, a clinician does not have sufficient information to predict whether transmurality may be reached.

[0069] Conventional ablation systems may use a measured wall thickness calculated from human cadavers to predict useful ablation parameters. Alternatively, tissue wall measurement may be estimated by measuring signals acquired by a transducer placed in contact with the surface of tissue. However, the measurement is difficult in practice because within the signals acquired by the transducer the reflected pulses are difficult to distinguish from other background sound received by the transducer. Furthermore, conventional ICE catheter ultrasound systems may provide wall thickness information if the clinician is able to steer the ICE catheter viewing direction towards catheter tip. However, the clinician needs to distinguish the catheter tip from the image, and must measure the wall thickness by guessing relative position. This is a fully manual process which has a very high uncertainty and delays the treatment so much as to not be practical for use in daily practice.

[0070] While pre-interventional imaging with MRI or CT may provide heart wall thickness, this requires unusual and costly additional workflow steps and the data must be fused with interventional data that is not available during daily practice. Furthermore, while certain ablation parameters may be recommended with these systems, it is likely that, using conventional systems, ablations could be either overtreated, increasing the risk of heart wall puncture and thermal injury, or undertreated, causing subsequent electrical reconduction. Other related risks can occur such as loss of heart contractability. Because conventional systems lack automated tissue wall thickness measurement or, as discussed in more detail herein, a Tailored Ablation Index calculation, during an ablation procedure, the clinician must balance the extent of power and time of the ablation procedure without knowing the anatomy at the target area for the individual patient.

[0071] Systems of the invention overcome these challenges and provide a single intraoperative imaging and navigation system capable of providing the clinician highly reliable, real-time / near real-time anatomical and physiological feedback. In particular, systems of the invention provide for automatically determining a tissue wall thickness measurement. Further, systems of the invention use the measured tissue wall thickness information, in conjunction with one or more ablation parameters, to generate a Tailored Ablation Index (TAI) for individualized, automated and simultaneous feedback during an ablation procedure.

[0072] Systems of the invention are configured to receive and process ultrasound imaging data. In some embodiments, and as disclosed in more detail herein, the console processor is configured to receive the 3D image data in real-time or near real-time from a field-of-view sufficient to capture the anatomical region of interest and to reconstruct the 3D image in real-time or near real-time. The ultrasound imaging data may be intracardiac ultrasound image data. As such, the systems may use available 3D ICE catheters for acquiring ultra-fast 3D and / or 4D ultrasound image data of a considered cardiac and / or vascular anatomy for processing and combining with other data to generate the reconstructed digital anatomical model.

[0073] The systems of the invention may utilize multiple fields-of-view, e.g. cylindrical fields- of-view acquired with a rotating transducer array or a cylindrical folded transducer matrix. Thus, cylindrical / 360-degree imaging may be applied to provide an extended field-of view (FOV). In some embodiments, the systems of the invention may utilize an orbital field-of-view around the catheter, which may be different than the planar field-of-view of conventional ICE catheters with a matrix transducer. 3D ICE catheters with forward and with sideways transducer arrays are suitable as long as the field-of-view is sufficiently large to provide for reconstruction of an anatomical region of interest. For example, catheters facing sideways may be used as these catheters also cover the forward direction to some degree due to the opening angle of the ultrasound beam. Any field-of view implementations may be used to provide for, wherein necessary, imaging of the whole vascular geometry and its surroundings for each volume such that imaging may be 360 degrees around the catheter. In some embodiments, the ultrasound imaging data is received from a plurality of cylindrical fields-of-view. For example, in some embodiments, the plurality of cylindrical fields of view are acquired via a rotating transducer array and / or a cylindrical folded transducer matrix.

[0074] Systems of the invention are configured to be used with any ablation device. For example, the ablation catheter may use radio frequency (RF) ablation or pulsed-field ablation (PF A). As is known to persons skilled in the art, for RF ablation, tissue destruction occurs from the thermal energy associated with radiofrequency. Pulsed-field ablation uses a train of microsecond duration high amplitude electrical pulses to ablate tissue. For pulsed-field ablation, the electric field is most commonly produced by a high-voltage direct current delivered between two or more electrodes. The systems may use an intracardiac echography (ICE) catheter to image the target region where the ablation catheter is positioned. The ICE catheter provides the ultrasound signals to, for example, the console and / or processing unit. In some embodiments, the console and the ICE catheter together may operate as the imaging system.

[0075] The systems may include one or algorithms for calculating the tissue wall thickness measurement. The tissue wall thickness, also referred to as wall thickness, may be calculated by first identifying the ablation catheter within the field of view with ultrasound imaging. The ablation catheter may be identified within the field of view in relation to other anatomical structures. The systems may use an ICE imaging system to provide a wide field of view to capture the relevant area of the tissue, i.e. target region or anatomical region of interest. For example, the catheter may provide full or partial circumferential view 3D image data. That is, the catheter may provide a 360 degree view around the catheter tip (i.e., provides 3D image data). As disclosed herein, the 3D image data may be obtained from an ICE catheter system such that the data is full circumferential 3D image data. Additionally and / or alternatively, a sidelooking array transducer may be used to obtain full or partial circumferential 3D image data of the target region. By providing a full or partial 360 degree view, the systems avoid the need for manual steering. Importantly, and in contrast to conventional systems, this reduces the time necessary for calculating tissue wall thickness and provides for real-time or near-real time feedback to a clinician.

[0076] Further, systems of the invention may generate an interactive and / or real-time patientspecific 3D digital anatomical model of the target region of interest using one or more algorithms. The systems of the invention are configured to run, via the console one or more imaging algorithms configured to analyze the 3D ultrasound image data and identify one or more anatomical structures of interest. Systems of the invention generate a reliable and anatomically correct real-time or near real-time patient-specific 3D digital anatomical model. The systems of the invention may receive, process, and combine real-time catheter-based ultrasound imaging data with other data to reconstruct a representation of the digital anatomy.

[0077] For example, systems of the invention may adapt and utilize one or more image segmentation algorithms for generating a patient-specific digital anatomical model. Image segmentation is the process of dividing an image into multiple meaningful and homogeneous regions or objects based on their inherent characteristics, such as color, texture, shape, or brightness. Each pixel may be labeled, and all pixels belonging to the same category may have a common label assigned to them. Segmentation may be achieved via instance image segmentation in which each object in an image is detected and segmented, via one or more algorithms to separate overlapping objects. Segmentation may be achieved via semantic segmentation in which one or more algorithms are used to label each pixel. Segmentation may be achieved via panoptic segmentation in which one or more machine learning algorithms are used to label each pixel with a class label and to identify each object instance in the image to provide for detection and interaction of the object within the environment. CV-based techniques may be used to combine multiple image data into an anatomical representation that combines the multiple image data into a large anatomical representation. Segmentation may be performed by a vision algorithm such as thresholding, connected component analysis, or a neural network based segmentation. Segmentation of the full panoramic volumes may be performed, for example, via a deep learning algorithm.

[0078] In some embodiments, the segmentation algorithm may identify the anatomical surrounding and the ablation catheter in the 3D image data, such that a region of interest with anatomical context may be provided. The region of interest may define an area where tissue wall thickness will be reconstructed. In some embodiments, the one or more imaging algorithms are configured to calculate the position and orientation of the ablation catheter relative to a targeted tissue within a heart anatomy such that an exact position of the ablation catheter and the electrode tip relative to the targeted tissue may be identified. For example, systems of the invention may generate a patient-specific 3D digital anatomical model based on 4D image data acquired along an ICE catheter’s trajectory over time, and provide for navigation of the ICE catheter to the target region of interest. In some embodiments, the systems utilize medical image registration, computer vision (CV)-based approaches, and / or simultaneous localization and mapping (SLAM).

[0079] SLAM is a computational method that constructs or updates a map of an unknown environment while simultaneously keeping track of an agent’s location within it. In some embodiments, systems of the invention adapt and utilize one or more algorithms for SLAM applications to ultrasound image data acquired to generate the patient-specific anatomical model as well as to navigate the catheter. For example, SLAM processing techniques may be adapted for use in conjunction with the catheter utilizing various sensors to incrementally build the map of a patient anatomical environment and simultaneously determine the location of the catheter within the map. Thus, the systems of the invention may use adapted SLAM techniques to combine multiple image data into an anatomical representation that combines the multiple image data into a large anatomical representation.

[0080] CV-based image reconstruction approaches utilized by systems of the invention may include approaches based on deep neural networks (DNNs) such as autoencoders (AEs), convolutional neural networks (CNNs), and generative adversarial networks (GANs). The computer vision approaches utilized by systems of the invention aim to detect, interpret and reconstruct data in a way that mimics the intricacy of the human visual system thus providing for intuitive navigation to precisely target an anatomical region.

[0081] Reconstruction of an interactive digital model of an imaged anatomy and / or region of interest may include segmentation, initialization, continuous 3D image registration, fdtering, optimization, 3D fusion, and panoramic image reconstruction. The systems may use multimodal image registration using one or more algorithms to correlate morphologic and / or functional features between images. The systems may filter the 3D ultrasound images, subsequent to initialization, along the ICE catheter’s trajectory. For example, filtering may include using pulse phase-gating. The pulse-phase gating may be ECG-gating in some embodiments. Continuous registration may include registering 3D ultrasound images of the same cardiac phase against the respective previous 3D ultrasound image or a current fused 3D image.

[0082] Image registration is the process of aligning multiple data, i.e. images, volumes, or surfaces to a patient coordinate system. Systems of the invention may utilize one or more registration algorithms to, for example, combine images of the patient and / or data from different modalities and to align temporal sequences of images to generate the interactive and / or real-time patient-specific digital anatomical model. The one or more algorithms find an optimal spatial transformation that best aligns the underlying anatomical structures for reconstruction of the digital anatomical model. Thus, the systems of the invention may use image registration techniques to combine multiple image data into an anatomical representation that combines the multiple image data into a large anatomical representation.

[0083] Systems of the invention may receive 3D position and orientation data of the catheter, and process and combine this data with the ultrasound imaging data and / or other data, such as pulse-phase data, for reconstruction of the digital anatomical model. It is noted however, that in some embodiments, reconstruction of the digital anatomical model is possible without measured 3D position data. In this case, the 3D position may be inferred from the image data. The 3D position and orientation data may be referred to as 3D pose data. 3D pose data may be 6 degree- of-freedom tracking including position and orientation. The 3D pose data may comprise a position and orientation in 3D space. Tracking data may be used by the console to map the ultrasound image data to the patient coordinate system. Accordingly, the systems of the invention may provide for the real-time 3D localization and tracking of the catheter, for example an ICE catheter, and interventional tools within the patient coordinate system.

[0084] The one or more algorithms may include identifying the position / orientation and / or location of the ablation catheter and its relation to heart anatomy. Calculating a position and / or orientation of the ablation catheter may include receiving data from one or more position sensors. For example, the ablation catheter position and / or orientation may be calculated using positional sensing.

[0085] The 3D pose data may be obtained through electromagnetic (EM) tracking, impedance tracking, image-based tracking, fiber-optic shape sensing, and / or a combination of these modalities. In some embodiments, EM tracking data is used. Electromagnetic tracking generates a defined EM field in which EM micro sensors are tracked. 6 degree-of-freedom tracking information (spatial position and orientation) may be acquired, for example, by embedding micro sensors into rigid or flexible instruments, where they serve as localization points for the instrument in space. The micro sensors can be embedded, for example, in a coil in the catheter tip. This allows for tracking the catheter tip position inside an electromagnetic field. The EM field generator emits a low intensity, varying EM field that establishes a measurement volume. Small currents are induced inside the sensors when they enter the EM field. The currents are relayed to the sensor interface unit where they are amplified and digitized as signals. The signals are transmitted to the console which calculates each sensor’s position and orientation as a transformation.

[0086] In some embodiments EM tracking of interventional tools is also incorporated. Thus, in some embodiments, the 3D position data comprises a spatial position and an orientation of a catheter and / or an interventional tool. In some embodiments, the 3D pose data is obtained through optical fiber shape sensing. For example, in some embodiments the fiber optic shape sensing comprises a fiber Bragg grating (FBG) sensor. For example, low reflectance FBG strain sensors may be positioned in a multi -core fiber within the catheter to determine how a point along the fiber is positioned in space. By sensing the relative change of FBGs in each of three or more fiber cores, the three-dimensional position can be determined.

[0087] The one or more algorithms may include subsequent optimization steps. Subsequent optimization steps increase the accuracy of the localization of each image in the patient’s coordinate system. The optimization steps also ensure robustness of the system. For example, where 3D pose data comprises EM tracking data, optimization ensures robustness of the systems against missing EM tracking data, for instance where the ICE catheter leaves the EM tracking field. To provide for improved robustness of registration in the case of inaccurate EM data used for initialization, or in the case of limited image features (e.g. when the ICE catheter is in the inferior vena cava (IVC) next to the lung), an additional tracking scheme may be used. The tracking scheme may use the EM tracking data and the previous registration results to predict the next 3D position. The predicted next 3D position may then be used for initialization of the continuous registration. To further provide for improved registration in regions with few features, prior knowledge of the imaged anatomy may be applied.

[0088] The systems may combine the received data and further continuously register subsequent 3D ultrasound images within the physical patient’s coordinate system, such that the continuously registered subsequent 3D ultrasound images may be partly overlapping. The continuously registered and partly overlapping subsequent 3D ultrasound images may then be fused into a large 3D image representing a patient-specific panoramic reconstruction of the anatomy. This 3D panoramic reconstruction may be updated sequentially over time as the catheter is moved through the anatomical region or regions of interest, such that the patient-specific digital 3D anatomical model may be continuously updated with subsequent registration and segmentation results.

[0089] The digital anatomical model may encapsulate a representation of the anatomy in a spatial topology for live visualization of one or more anatomical regions of interest. The spatial topology may include a topological map, such that each point in the topological map represents tissue and / or one or more specific anatomical properties. Thus, ultrasound imaging data from one or more directions and / or one or more views may be combined to provide the representation of the anatomy. This representation may be a panoramic image reconstruction (i.e. an intensity volume), a (segmented) surface model, and / or a mesh. The digital anatomy may also be a more advanced representation of the anatomy, where for each point in the topological map, a representation of tissue or specific anatomical properties are encapsulated, such that different views or information from different directions can be combined for a complete representation. Thus, by reconstructing an interactive digital anatomical model, based on the processing and combining of the received data, the systems of the invention provide a digital anatomical model similar to computed tomography (CT), magnetic resonance imaging (MRI), or Ultrasound Tomographic reconstructions. The digital model encapsulates a representation of the anatomy in a spatial topology for live visualization of one or more anatomical regions of interest for fast and accurate calculation of a tissue wall thickness and / or a distance of the electrode tip from the targeted tissue may be calculated and a contact point of the electrode with the targeted tissue may be determined based on said calculated distance.

[0090] The systems may generate one or more 3D anatomical landmarks. To aid the navigation of the ICE catheter and interventional tools, a detection and localization step may be added to automatically find prominent anatomical landmarks. These landmarks may be visualized in 3D along with the model. The systems may provide for tracking of interventional tools within the 3D model. The console may be further configured to detect, localize, and segment in the 3D ultrasound images, relevant interventional tools. The segmented tools may visualized along with the 3D digital anatomical model. In addition to physical tracking and navigation, the invention provides for contact assessment between the tool tip and cardiac or vascular wall.

[0091] In some embodiments, the model may be generated once when all of the 3D ultrasound image data is available. After model generation, navigation of the ICE catheter as well as tracking and navigation of interventional tools is possible. The anatomical context generated with the model enables safer navigation of catheter tools.

[0092] Thus, as disclosed herein, systems of the invention may receive 3D position and orientation data of the catheter, and process and combine this data with the ultrasound imaging data and / or other data for reconstruction of a patient-specific digital anatomical model. The position and orientation of the catheter in combination with imaging data from ablation catheters may be used to reconstruct the tissue wall thickness and to provide feedback to a clinician before and during an ablation procedure. Different catheter configurations may be used with systems of the invention a clinician. In non-limiting examples, the catheter may include single electrodes on a point by point catheter, a multi -el ectrode catheter (i.e. spline catheter, balloon catheter, etc ), one or more splines with one or more distinct electrodes, spline electrodes on basket catheters, and the like. In non-limiting examples, the tip of the electrode may refer to the tip of the electrode in the contact region. The tip of the electrode may be tip-like but also flat.

[0093] The systems of the method determine whether the one or more electrodes are in contact with a tissue. Once the ablation catheter location is identified, one or more algorithms may use 3D segmentation results to determine the exact position of the ablation catheter and its electrode tip in relation to the anatomical region of interest to be treated, e.g. area of the heart wall. The one or more algorithms may measure the distance between the catheter's electrode tip and a tissue wall, such as the heart wall. The measured distance between the catheter electrode tip and the tissue wall may then be used to determine a contact point of the electrode with the targeted tissue and to provide feedback to a user as to the distance of the electrode to the contact point.

[0094] In cases where no contact is yet achieved, the information may be used to provide the user with a distance to target to achieve contact. Thus, if the catheter electrode(s) is not in contact, the systems may provide navigation guidance to achieved tissue contact. In some embodiments, the systems provide information to the user as to whether status of tissue contact, for example feedback that no successful ablation will be generated without tissue contact, or a real-time calculation of distance to tissue for navigation to the region of interest. If the calculated distance is zero, the user may receive a feedback or indication that the tip of the electrode is in contact with the heart wall. Furthermore, the catheter tip location may be determined relative to the heart chamber anatomy as identified by, for example, the segmentation algorithm. Accordingly, for catheter electrodes (i.e. the points where ablation energy would be delivered) both the distance to a targeted tissue area, as well as the contact with tissue, may be used in the calculation to limit the tissue wall thickness measurement to a focused area in the targeted tissue.

[0095] Once the contact point of the ablation catheter is determined, image data, for example 3D ICE image data may be further analyzed to measure the tissue wall thickness underneath the ablation catheter tip. Where the 3D ultrasound image data is obtained from an ICE catheter system, the ultrasound signals may be used to provide information on the tissue wall thickness, for example the heart wall tissue thickness. The interfaces between the tissue wall thickness and blood or other tissues may lead to other reflections which may be identified through one or more imaging algorithms. Calculated Tailored Ablation Index (TAI)

[0096] Further, systems of the invention provide for extracting the tissue wall thickness information locally and using this information to reconstruct an improved “ablation index.” Conventionally, ablation index (Al) is used as a marker for lesion quality. Ablation index utilizes contact force (CF), time, and power in a weighted formula to determine lesion quality. For example, as is conventionally utilized, a minimum Al is predictive of pulmonary vein isolation segment reconnection. Ablation index linearly correlates with lesion depth.

[0097] As detailed in Motoike, et al., 2020, “Wall thickness-based adjustment of ablation index improves efficacy of pulmonary vein isolation in atrial fibrillation: Real-time assessment by intracardiac echocardiography,” Journal of Cardiovascular Electrophysiology, vol. 32, no. 6, incorporated by reference in its entirety herein, clinical studies show that Al-guided interventions lead to less re-interventions. The so-called tailored-AI (TAI) considers locally measured wall thicknesses, and, using the TAI, it is more likely that the conduction block endures and a reintervention after several months is not necessary. However, in contrast to the present invention, in previous work using TAI, the required wall thickness information was obtained via manual measurement using ICE image data with non-trivial steering of the ICE catheter. Notably, this conventional method is a time-consuming and error-prone task that hinders the application in clinical practice.

[0098] The present systems provide an automatic, fast, and accurate wall thickness measurement from the 3D image data without the need for manual steering. In some embodiments, the distance from a heart wall is measured from the electrode tip, wherein the tissue thickness measurement is a cardiac wall thickness measurement. When the electrode(s) is in contact with tissue, the wall thickness information is extracted locally, which is then used to reconstruct, via one or more algorithms, a TAI value in real-time or near real-time. Thus, in some embodiments, the instructions executable by the processor further cause the console to calculate, using the targeted tissue thickness measurement, a Tailored Ablation Index (TAI) value for a projected ablation lesion depth.

[0099] For example, the TAI may be calculated using the tissue thickness measurement and one or more ablation catheter parameters. The algorithm may use one or more ablation parameters, such as power and time, in addition to contact force of the ablation electrode against the tissue, in combination with the calculated wall thickness measurement to calculate a projected lesion depth. Thus, the one or more algorithms may use the measured data for wall thickness in conjunction with the ablation parameters to calculate a TAI value. In some embodiments, the cardiac wall thickness measurement is combined with a regression formula to calculate the projected lesion depth. For example, the wall thickness measurement may be combined with a regression formula for calculating a projected lesion depth from power (P) and time (d) ablation parameters of the ablation generator as well as the contact force (CF) of the ablation electrode onto the tissue wall.

[0100] In some embodiments, the processor further causes the console to determine, during an ablation procedure, whether a created lesion depth is sufficient to treat a condition. The calculated projected lesion depth may be used to enable whether a projected lesion depth before ablation will be sufficient and / or whether a lesion depth after ablation will be sufficiently transmural. In some embodiments, determining whether a created lesion depth is sufficient comprises applying one or more thresholds to the calculated TAI value, wherein the one or more thresholds vary between anatomical regions in the heart. For example, the anatomical regions of the heart may be identified and a TAI threshold may be automatically provided via the one or more algorithms.

[0101] In some embodiments, the console is further configured to output, via a display, visualization of the anatomical region of interest as a 3D model, wherein the output includes visualization of the identified position of the ablation catheter tip within the anatomical region of interest. For example, the output may provide feedback to a user as one or more of a guidance to achieve the contact point of the electrode tip with the targeted tissue, a distance from the electrode tip to the targeted tissue, and / or the sufficiency of the created lesion depth. For example, the systems of the invention, via the one or more algorithms, may display on a screen through color coding whether the created lesion depth is sufficient (transmurality is achieved). This may be achieved by applying thresholds to the computed TAI values. The thresholds may vary between locations of the heart. For example, according to clinical studies, the thresholds of TAI are different between anterior and superior walls in the left atrium. Therefore the systems provide for locations like the anterior and / or superior walls to be identified by the systems and to automatically calculate the TAI threshold for the anatomical location. Precise locations of the targeted tissue may be derived from anatomical analysis though the segmentation algorithms used. The systems provide feedback to the user as to the sufficiency of a projected lesion depth as well as a lesion during the ablation procedure. For example, in some embodiments, the sufficiency of the created lesion depth comprises an indicator configured to indicate that the created lesion depth is sufficiently transmural. For example, the feedback and / or indicator may be one or more of a color, a shape, a texture, and a shading configured to indicate that the created lesion depth is sufficiently transmural. That is, the feedback may be via an indicator on the display such as a color, shape, texture, shading or the like that indicates the sufficiency of transmurality of the lesion. In a non-limiting example, a user may see the segmented heart anatomy as a 3D surface as well as the located ablation catheter tip. The tip may be represented as a color, for example, represented in red as long as the lesion is not sufficiently transmural and may turn to green once sufficient transmurality is reached. The direct feedback helps the clinician to decide that the ablation at this location is sufficient and may be used to decide to continue the treatment at a following location.

[0102] Methods for calculating a projected lesion depth

[0103] Aspects of the invention provide methods for providing a projected ablation lesion depth. FIG. 4 illustrates a block diagram of a method 400 for providing a projected ablation lesion depth according to one embodiment of the invention. The method includes providing a console configured to be operably associated with an ultrasound imaging device and exchange data therewith. The method further includes receiving and analyzing 401, via the console, three- dimensional (3D) ultrasound image data from an ultrasound imaging device, the 3D ultrasound image data being associated with an anatomical region of interest in which an ablation catheter is positioned, said ablation catheter comprising at least one electrode comprising an electrode tip. Further, the method includes calculating a position and orientation of the ablation catheter and the electrode tip in relation to a targeted tissue within the anatomical region of interest 403, whereby a distance of the electrode tip from the targeted tissue is calculated and a contact point of the electrode with the targeted tissue is determined based on said calculated distance.

[0104] As disclosed herein, the methods may include a console in active communication with a computing system configured to communicate across a network. The console may be configured to be operably associated with an ultrasound imaging device, as well as with other devices and / or means for receiving data, and to exchange data therewith. The console may comprise a hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor to cause the console to receive data associated with at least one of cardiac and vascular anatomy the data comprising catheter-based ultrasound imaging data, and, in some embodiments, pulse phase data and / or 3D position data. The console is operable to process and combine the received data, and reconstruct, based on said processing and combining of data, an interactive digital model of an imaged anatomy, wherein the digital model encapsulates a representation of the anatomy in a spatial topology for live visualization of one or more anatomical regions of interest.

[0105] The computing system or computing device may include one or more processors and memory, as well as an input / output mechanism (i.e., a keyboard, knobs, scroll wheels, or the like) with which a user can interact so as to operate the console, including making adjustments to the ultrasound imaging system, saving images, segmentation, initialization, continuous 3D image registration, filtering, optimization, 3D fusion, and panoramic image reconstruction.

[0106] The computing system may include a computer program comprising one or more algorithms for image registration, filtering, optimization, and reconstruction of the digital anatomical model. For example, the algorithm may be part of a computer program executable by the computing system and in communication with the console of the system. The system may be in communication with the imaging device to receive 3D ultrasound image data from the imaging device.

[0107] As disclosed in detail herein, imaging protocols and algorithms may be used to dynamically reconstruct properties of the anatomy. The method may include utilizing one or more algorithms for dynamically reconstructing multiple images from the 3D image data to provide a 3D visualization of the anatomical region of interest and targeted tissue site.

[0108] The methods further include calculating, using the 3D ultrasound image data and the contact point, a contact point of the electrode with the targeted tissue, and a measurement of thickness of the targeted tissue proximate to or beneath the electrode tip.

[0109] Receiving and analyzing 3D ultrasound imaging data

[0110] The methods of the invention provide for measuring tissue wall thickness at the location where the catheter is applying energy to the tissue to generate a lesion. Without this real-time or near real-time information, a clinician does not have sufficient information to predict whether transmurality may be reached. Methods of the invention overcome the drawbacks of conventional methods for measuring tissue depth, i.e. heart wall, and provide for utilizing a single intraoperative imaging and navigation system capable of providing the clinician highly reliable, real-time / near real-time anatomical and physiological feedback. In particular, methods of the invention provide for automatically determining a tissue wall thickness measurement. Further, methods of the invention use the measured tissue wall thickness information, in conjunction with one or more ablation parameters, to generate a Tailored Ablation Index (TAI) for individualized, automated and simultaneous feedback during an ablation procedure.

[0111] Methods of the invention are configured to receive and process ultrasound imaging data. In some embodiments, and as disclosed in more detail herein, the console processor is configured to receive the 3D image data in real-time or near real-time from a field-of-view sufficient to capture the anatomical region of interest and to reconstruct the 3D image in real-time or near real-time. The ultrasound imaging data may be intracardiac ultrasound image data. As such, the methods may use available 3D ICE catheters for acquiring ultra-fast 3D and / or 4D ultrasound image data of a considered cardiac and / or vascular anatomy for processing and combining with other data to generate the reconstructed digital anatomical model.

[0112] The methods of the invention may utilize multiple fields-of-view, e.g. cylindrical fields- of-view acquired with a rotating transducer array or a cylindrical folded transducer matrix. Thus, cylindrical / 360-degree imaging may be applied to provide an extended field-of view (FOV). In some embodiments, the methods of the invention may utilize an orbital field-of-view around the catheter, which may be different than the planar field-of-view of conventional ICE catheters with a matrix transducer. 3D ICE catheters with forward and with sideways transducer arrays are suitable as long as the field-of-view is sufficiently large to provide for reconstruction of an anatomical region of interest. For example, catheters facing sideways may be used as these catheters also cover the forward direction to some degree due to the opening angle of the ultrasound beam. Any field-of view implementations may be used to provide for, wherein necessary, imaging of the whole vascular geometry and its surroundings for each volume such that imaging is 360 degrees around the catheter. In some embodiments, the ultrasound imaging data is received from a plurality of cylindrical fields-of-view. For example, in some embodiments, the plurality of cylindrical fields of view are acquired via a rotating transducer array and / or a cylindrical folded transducer matrix. Methods of the invention may be used with any ablation device. For example, the ablation catheter may use radio frequency (RF) ablation or pulsed-field ablation (PF A). As is known to persons skilled in the art, for RF ablation, tissue destruction occurs from the thermal energy associated with radiofrequency. Pulsed-field ablation uses a train of microsecond duration high amplitude electrical pulses to ablate tissue. For pulsed-field ablation, the electric field is most commonly produced by a high-voltage direct current delivered between two or more electrodes. The system may use an intracardiac echography (ICE) catheter to image the target region where the ablation catheter is positioned. The ICE catheter provides the ultrasound signals to, for example, the console and / or processing unit. In some embodiments, the console and the ICE catheter together may operate as the imaging system.

[0113] The methods may include one or algorithms for calculating the tissue wall thickness measurement. The tissue wall thickness, also referred to as wall thickness, may be calculated by first identifying the ablation catheter within the field of view with ultrasound imaging. The ablation catheter may be identified within the field of view in relation to other anatomical structures. The methods may use an ICE imaging system to provide a wide field of view to capture the relevant area of the tissue, i.e. target region or anatomical region of interest. For example, the catheter may provide full or partial circumferential view 3D image data. That is, the catheter may provide a 360 degree view around the catheter tip (i.e., provides 3D image data). As disclosed herein, the 3D image data may be obtained from an ICE catheter system such that the data is full circumferential 3D image data. Additionally and / or alternatively, a sidelooking array transducer may be used to obtain full or partial circumferential 3D image data of the target region. By providing a full or partial 360 degree view, the methods avoid the need for manual steering. Importantly, and in contrast to conventional methods, this reduces the time necessary for calculating tissue wall thickness and provides for real-time or near-real time feedback to a clinician.

[0114] Further, methods of the invention may generate an interactive and / or real-time patientspecific 3D digital anatomical model of the target region of interest using one or more algorithms. The methods of the invention are configured to run, via the console one or more imaging algorithms configured to analyze the 3D ultrasound image data and identify one or more anatomical structures of interest. Methods of the invention generate a reliable and anatomically correct real-time or near real-time patient-specific 3D digital anatomical model. The methods of the invention may receive, process, and combine real-time catheter-based ultrasound imaging data with other data to reconstruct a representation of the digital anatomy.

[0115] For example, methods of the invention may adapt and utilize one or more image segmentation algorithms for generating a patient-specific digital anatomical model. Image segmentation is the process of dividing an image into multiple meaningful and homogeneous regions or objects based on their inherent characteristics, such as color, texture, shape, or brightness. Each pixel may be labeled, and all pixels belonging to the same category may have a common label assigned to them. Segmentation may be achieved via instance image segmentation in which each object in an image is detected and segmented, via one or more algorithms to separate overlapping objects. Segmentation may be achieved via semantic segmentation in which one or more algorithms are used to label each pixel. Segmentation may be achieved via panoptic segmentation in which one or more machine learning algorithms are used to label each pixel with a class label and to identify each object instance in the image to provide for detection and interaction of the object within the environment. CV-based techniques may be used to combine multiple image data into an anatomical representation that combines the multiple image data into a large anatomical representation. Segmentation may be performed by a vision algorithm such as thresholding, connected component analysis, or a neural network-based segmentation. Segmentation of the full panoramic volumes may be performed, for example, via a deep learning algorithm.

[0116] In some embodiments, the segmentation algorithm may identify the anatomical surrounding and the ablation catheter in the 3D image data, such that a region of interest with anatomical context is provided. The region of interest may define an area where tissue wall thickness will be reconstructed. In some embodiments, the one or more imaging algorithms are configured to calculate the position and orientation of the ablation catheter relative to a targeted tissue within a heart anatomy such that an exact position of the ablation catheter and the electrode tip relative to the targeted tissue is identified. For example, systems of the invention may generate a patient-specific 3D digital anatomical model based on 4D image data acquired along an ICE catheter’s trajectory over time, and provide for navigation of the ICE catheter to the target region of interest. In some embodiments, the systems utilize medical image registration, computer vision (CV)-based approaches, and / or simultaneous localization and mapping (SLAM). Simultaneous localization and mapping (SLAM) is a computational method that constructs or updates a map of an unknown environment while simultaneously keeping track of an agent’s location within it. In some embodiments, methods of the invention adapt and utilize one or more algorithms for SLAM applications to ultrasound image data acquired to generate the patient-specific anatomical model as well as to navigate the catheter. For example, SLAM processing techniques may be adapted for use in conjunction with the catheter utilizing various sensors to incrementally build the map of a patient anatomical environment and simultaneously determine the location of the catheter within the map. Thus, the systems of the invention may use adapted SLAM techniques to combine multiple image data into an anatomical representation that combines the multiple image data into a large anatomical representation.

[0117] CV-based image reconstruction approaches utilized by systems of the invention may include approaches based on deep neural networks (DNNs) such as autoencoders (AEs), convolutional neural networks (CNNs), and generative adversarial networks (GANs). The computer vision approaches utilized by systems of the invention aim to detect, interpret and reconstruct data in a way that mimics the intricacy of the human visual system thus providing for intuitive navigation to precisely target an anatomical region.

[0118] Reconstruction of an interactive digital model of an imaged anatomy and / or region of interest may include segmentation, initialization, continuous 3D image registration, fdtering, optimization, 3D fusion, and panoramic image reconstruction. The methods may use multimodal image registration using one or more algorithms to correlate morphologic and / or functional features between images. The methods may filter the 3D ultrasound images, subsequent to initialization, along the ICE catheter’s trajectory. For example, filtering may include using pulse phase-gating. The pulse-phase gating may be ECG-gating in some embodiments. Continuous registration may include registering 3D ultrasound images of the same cardiac phase against the respective previous 3D ultrasound image or a current fused 3D image.

[0119] Image registration is the process of aligning multiple data, i.e. images, volumes, or surfaces to a patient coordinate system. Methods of the invention may utilize one or more registration algorithms to, for example, combine images of the patient and / or data from different modalities and to align temporal sequences of images to generate the interactive and / or real-time patient-specific digital anatomical model. The one or more algorithms find an optimal spatial transformation that best aligns the underlying anatomical structures for reconstruction of the digital anatomical model. Thus, the methods of the invention may use image registration techniques to combine multiple image data into an anatomical representation that combines the multiple image data into a large anatomical representation.

[0120] Methods of the invention may receive 3D position and orientation data of the catheter, and process and combine this data with the ultrasound imaging data and / or other data, such as pulse-phase data, for reconstruction of the digital anatomical model. It is noted however, that in some embodiments, reconstruction of the digital anatomical model is possible without 3D position data. The 3D position and orientation data may be referred to as 3D pose data. 3D pose data may be 6 degree-of-freedom tracking including position and orientation. The 3D pose data may comprise a position and orientation in 3D space. Tracking data may be used by the console to map the ultrasound image data to the patient coordinate system. Accordingly, the methods of the invention may provide for the real-time 3D localization and tracking of the catheter, for example an ICE catheter, and interventional tools within the patient coordinate system.

[0121] Calculating distance of the electrode tip from targeted tissue and calculating contact point

[0122] The methods includes calculating a position and orientation of the ablation catheter and the electrode tip in relation to a targeted tissue within the anatomical region of interest in the digital image. A distance of the electrode tip from the targeted tissue is calculated and a contact point of the electrode with the targeted tissue is determined based on said calculated distance.

[0123] One or more algorithms may be included to identify the position / orientation and / or location of the ablation catheter and its relation to heart anatomy. Calculating a position and / or orientation of the ablation catheter may include receiving data from one or more position sensors. For example, the ablation catheter position and / or orientation may be calculated using positional sensing.

[0124] The 3D pose data may be obtained through electromagnetic (EM) tracking, impedance tracking, image-based tracking, fiber-optic shape sensing, and / or a combination of these modalities. In some embodiments, EM tracking data is used. Electromagnetic tracking generates a defined EM field in which EM micro sensors are tracked. 6 degree-of-freedom tracking information (spatial position and orientation) may be acquired, for example, by embedding micro sensors into rigid or flexible instruments, where they serve as localization points for the instrument in space. The micro sensors can be embedded, for example, in a coil in the catheter tip. This allows for tracking the catheter tip position inside an electromagnetic field. The EM field generator emits a low intensity, varying EM field that establishes a measurement volume. Small currents are induced inside the sensors when they enter the EM field. The currents are relayed to the sensor interface unit where they are amplified and digitized as signals. The signals are transmitted to the console which calculates each sensor’s position and orientation as a transformation.

[0125] In some embodiments, EM tracking of interventional tools is also incorporated. Thus, in some embodiments, the 3D position data comprises a spatial position and an orientation of a catheter and / or an interventional tool. In some embodiments, the 3D pose data is obtained through optical fiber shape sensing. For example, in some embodiments the fiber optic shape sensing comprises a fiber Bragg rating (FBG) sensor. For example, low reflectance FBG strain sensors may be positioned in a multi-core fiber within the catheter to determine how a point along the fiber is positioned in space. By sensing the relative change of FBGs in each of three or more fiber cores, the three-dimensional position can be determined.

[0126] The one or more algorithms may include subsequent optimization steps. Subsequent optimization steps increase the accuracy of the localization of each image in the patient’s coordinate system. The optimization steps also ensure robustness of the system. For example, where 3D pose data comprises EM tracking data, optimization ensures robustness of the system against missing EM tracking data, for instance where the ICE catheter leaves the EM tracking field. To provide for improved robustness of registration in the case of inaccurate EM data used for initialization, or in the case of limited image features (e.g. when the ICE catheter is in the inferior vena cava (IVC) next to the lung), an additional tracking scheme may be used. The tracking scheme may use the EM tracking data and the previous registration results to predict the next 3D position. The predicted next 3D position may then be used for initialization of the continuous registration. To further provide for improved registration in regions with few features, prior knowledge of the imaged anatomy may be applied.

[0127] The methods may combine the received data and further continuously register subsequent 3D ultrasound images within the physical patient’s coordinate system, such that the continuously registered subsequent 3D ultrasound images may be partly overlapping. The continuously registered and partly overlapping subsequent 3D ultrasound images may then be fused into a large 3D image representing a patient-specific panoramic reconstruction of the anatomy. This 3D panoramic reconstruction may be updated sequentially over time as the catheter is moved through the anatomical region or regions of interest, such that the patient-specific digital 3D anatomical model is continuously updated with subsequent registration and segmentation results.

[0128] The digital anatomical model may encapsulate a representation of the anatomy in a spatial topology for live visualization of one or more anatomical regions of interest. The spatial topology may include a topological map, such that each point in the topological map represents tissue and / or one or more specific anatomical properties. Thus, ultrasound imaging data from one or more directions and / or one or more views may be combined to provide the representation of the anatomy. This representation may be a panoramic image reconstruction (i.e. an intensity volume), a (segmented) surface model, and / or a mesh. The digital anatomy may also be a more advanced representation of the anatomy, where for each point in the topological map, a representation of tissue or specific anatomical properties are encapsulated, such that different views or information from different directions can be combined for a complete representation. Thus, by reconstructing an interactive digital anatomical model, based on the processing and combining of the received data, the systems of the invention provide a digital anatomical model similar to computed tomography (CT), magnetic resonance imaging (MRI), or Ultrasound Tomographic reconstructions. The digital model encapsulates a representation of the anatomy in a spatial topology for live visualization of one or more anatomical regions of interest for fast and accurate calculation of a tissue wall thickness and / or a distance of the electrode tip from the targeted tissue is calculated and a contact point of the electrode with the targeted tissue is determined based on said calculated distance.

[0129] The methods may generate one or more 3D anatomical landmarks. To aid the navigation of the ICE catheter and interventional tools, a detection and localization step may be added to automatically find prominent anatomical landmarks. These landmarks may be visualized in 3D along with the model. The systems may provide for tracking of interventional tools within the 3D model. The console may be further configured to detect, localize, and segment in the 3D ultrasound images, relevant interventional tools. The segmented tools may be visualized along with the 3D digital anatomical model. In addition to physical tracking and navigation, the invention provides for contact assessment between the tool tip and cardiac or vascular wall.

[0130] In some embodiments of the methods, the model is generated once when all of the 3D ultrasound image data is available. After model generation, navigation of the ICE catheter as well as tracking and navigation of interventional tools is possible. The anatomical context generated with the model enables safer navigation of catheter tools.

[0131] Thus, as disclosed herein, methods of the invention may receive 3D position and orientation data of the catheter, and process and combine this data with the ultrasound imaging data and / or other data for reconstruction of a patient-specific digital anatomical model. The position and orientation of the catheter in combination with imaging data from ablation catheters is used to reconstruct the tissue wall thickness and to provide feedback to a clinician before and during an ablation procedure. Different catheter configurations may be used with systems of the invention to reconstruct the tissue wall thickness and to provide feedback to a clinician before and during an ablation procedure. In non-limiting examples, the catheter may include single electrodes on a point by point catheter, a multi-electrode catheter (i.e. spline catheter, balloon catheter, etc ), one or more splines with one or more distinct electrodes, spline electrodes on basket catheters, and the like. In non-limiting examples, the tip of the electrode may refer to the tip of the electrode in the contact region. The tip of the electrode may be tip-like but also flat.

[0132] The methods of the method determine whether the one or more electrodes are in contact with a tissue. Once the ablation catheter location is identified, one or more algorithms may use 3D segmentation results to determine the exact position of the ablation catheter and its electrode tip in relation to the anatomical region of interest to be treated, e.g. area of the heart wall. The one or more algorithms may measure the distance between the catheter's electrode tip and a tissue wall, such as the heart wall. The measured distance between the catheter electrode tip and the tissue wall may then be used to determine a contact point of the electrode with the targeted tissue and to provide feedback to a user as to the distance of the electrode to the contact point.

[0133] In cases where no contact is yet achieved, the information may be used to provide the user with a distance to target to achieve contact. Thus, if the catheter electrode(s) is not in contact, the methods may provide navigation guidance to achieved tissue contact. In some embodiments, the methods provide information to the user as to whether status of tissue contact, for example feedback that no successful ablation will be generated without tissue contact, or a real-time calculation of distance to tissue for navigation to the region of interest. If the calculated distance is zero, the user may receive a feedback or indication that the tip of the electrode is in contact with the heart wall. Furthermore, the catheter tip location may be determined relative to the heart chamber anatomy as identified by, for example, the segmentation algorithm. Accordingly, for catheter electrodes (i.e. the points where ablation energy would be delivered) both the distance to a targeted tissue area, as well as the contact with tissue, may be used in the calculation to limit the tissue wall thickness measurement to a focused area in the targeted tissue.

[0134] Once the contact point of the ablation catheter is determined, image data, for example 3D ICE image data may be further analyzed to measure the tissue wall thickness underneath the ablation catheter tip. Where the 3D ultrasound image data is obtained from an ICE catheter system, the ultrasound signals may be used to provide information on the tissue wall thickness, for example the heart wall tissue thickness. The interfaces between the tissue wall thickness and blood or other tissues may lead to other reflections which may be identified through one or more imaging algorithms.

[0135] Calculating Tailored Ablation Index (TAI)

[0136] Methods of the invention provide for extracting the tissue wall thickness information locally and using this information to reconstruct an improved “ablation index.”

[0137] The present methods provide automatic, fast, and accurate wall thickness measurement from the 3D image data without the need for manual steering. In some embodiments, the distance from a heart wall is measured from the electrode tip, wherein the tissue thickness measurement is a cardiac wall thickness measurement. When the electrode(s) is in contact with tissue, the wall thickness information is extracted locally, which is then used to reconstruct, via one or more algorithms, a Tailored Ablation Index (TAI) value in real-time or near real-time. Thus, in some embodiments, the method includes calculating 405, using the targeted tissue thickness measurement, a TAI value for a projected ablation lesion depth.

[0138] For example, the TAI may be calculated using one or more algorithms, using the tissue thickness measurement and one or more ablation catheter parameters. The algorithm may use one or more ablation parameters, such as power and time, in addition to contact force of the ablation electrode against the tissue, in combination with the calculated wall thickness measurement to calculate a projected lesion depth. Thus, the one or more algorithms may use the measured data for wall thickness in conjunction with the ablation parameters to calculate a TAI value. In some embodiments, the cardiac wall thickness measurement is combined with a regression formula to calculate the projected lesion depth. For example, the wall thickness measurement may be combined with a regression formula for calculating a projected lesion depth from power (P) and time (d) ablation parameters of the ablation generator as well as the contact force (CF) of the ablation electrode onto the tissue wall.

[0139] The methods may include calculating 407 a projected lesion depth. In some embodiments, the methods include determining, during an ablation procedure, whether a created lesion depth is sufficient to treat a condition. The calculated projected lesion depth may be used to enable the decision as to whether a projected lesion depth before ablation will be sufficient and / or whether a lesion depth after ablation will be sufficiently transmural. In some embodiments, determining whether a created lesion depth is sufficient comprises applying one or more thresholds to the calculated TAI value, wherein the one or more thresholds vary between anatomical regions in the heart. For example, the anatomical regions of the heart may be identified and a TAI threshold may be automatically provided via the one or more algorithms.

[0140] In some embodiments of the methods, the console is further configured to output, via a display, visualization of the anatomical region of interest as a 3D model, wherein the output includes visualization of the identified position of the ablation catheter tip within the anatomical region of interest. Thus, some embodiments of the method include providing feedback 409 to a user before or during an ablation procedure. For example, the output may provide feedback to a user as one or more of a guidance to achieve the contact point of the electrode tip with the targeted tissue, a distance from the electrode tip to the targeted tissue, and / or the sufficiency of the created lesion depth. For example, the methods of the invention, via the one or more algorithms, may include displaying on a screen through, for example, color coding whether the created lesion depth is sufficient (transmurality is achieved). This may be achieved by applying thresholds to the computed TAI values. The thresholds may vary between locations of the heart. For example, according to clinical studies, the thresholds of TAI are different between anterior and superior walls in the left atrium. Therefore the methods provide for locations like the anterior and / or superior walls to be identified and to automatically calculate the TAI threshold for the anatomical location. Precise locations of the targeted tissue may be derived from anatomical analysis though the segmentation algorithms used.

[0141] The methods provide feedback to the user as to the sufficiency of a projected lesion depth as well as a lesion during the ablation procedure. For example, in some embodiments, the sufficiency of the created lesion depth comprises an indicator configured to indicate that the created lesion depth is sufficiently transmural. For example, the feedback and / or indicator may be one or more of a color, a shape, a texture, and a shading configured to indicate that the created lesion depth is sufficiently transmural. That is, the feedback may be via an indicator on the display such as a color, shape, texture, shading or the like that indicates the sufficiency of transmurality of the lesion. In a non-limiting example, a user may see the segmented heart anatomy as a 3D surface as well as the located ablation catheter tip. The tip may be represented as a color, for example, represented in red as long as the lesion is not sufficiently transmural and may turn to green once sufficient transmurality is reached. The direct feedback helps the clinician to decide that the ablation at this location is sufficient and may be used to decide to continue the treatment at a following location.

[0142] As used in any embodiment herein, the term “module” may refer to software, firmware and / or circuitry configured to perform any of the aforementioned operations. Software may be embodied as a software package, code, instructions, instruction sets and / or data recorded on non- transitory computer readable storage medium. Firmware may be embodied as code, instructions, or instruction sets and / or data that are hard-coded (e.g., nonvolatile) in memory devices. “Circuitry”, as used in any embodiment herein, may comprise, for example, singly or in any combination, hardwired circuitry, programmable circuitry such as computer processors comprising one or more individual instruction processing cores, state machine circuitry, and / or firmware that stores instructions executed by programmable circuitry. The modules may, collectively or individually, be embodied as circuitry that forms part of a larger system, for example, an integrated circuit (IC), system on-chip (SoC), desktop computers, laptop computers, tablet computers, servers, smartphones, etc.

[0143] Any of the operations described herein may be implemented in a system that includes one or more storage mediums having stored thereon, individually or in combination, instructions that when executed by one or more processors perform the methods. Here, the processor may include, for example, a server CPU, a mobile device CPU, and / or other programmable circuitry.

[0144] Also, it is intended that operations described herein may be distributed across a plurality of physical devices, such as processing structures at more than one different physical location. The storage medium may include any type of tangible medium, for example, any type of disk including hard disks, floppy disks, optical disks, compact disk read-only memories (CD-ROMs), compact disk rewritables (CD-RWs), and magneto-optical disks, semiconductor devices such as read-only memories (ROMs), random access memories (RAMs) such as dynamic and static RAMs, erasable programmable read-only memories (EPROMs), electrically erasable programmable read-only memories (EEPROMs), flash memories, Solid State Disks (SSDs), magnetic or optical cards, or any type of media suitable for storing electronic instructions. Other embodiments may be implemented as software modules executed by a programmable control device. The storage medium may be non-transitory.

[0145] As described herein, various embodiments may be implemented using hardware elements, software elements, or any combination thereof. Examples of hardware elements may include processors, microprocessors, circuits, circuit elements (e.g., transistors, resistors, capacitors, inductors, and so forth), integrated circuits, application specific integrated circuits (ASIC), programmable logic devices (PLD), digital signal processors (DSP), field programmable gate array (FPGA), logic gates, registers, semiconductor device, chips, microchips, chip sets, and so forth.

[0146] Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

[0147] The term "non-transitory" is to be understood to remove only propagating transitory signals per se from the claim scope and does not relinquish rights to all standard computer- readable media that are not only propagating transitory signals per se. Stated another way, the meaning of the term "non-transitory computer-readable medium" and "non-transitory computer- readable storage medium" should be construed to exclude only those types of transitory computer-readable media which were found in In Re Nuijten to fall outside the scope of patentable subject matter under 35 U.S.C. § 101.

[0148] The terms and expressions which have been employed herein are used as terms of description and not of limitation, and there is no intention, in the use of such terms and expressions, of excluding any equivalents of the features shown and described (or portions thereof), and it is recognized that various modifications are possible within the scope of the claims. Accordingly, the claims are intended to cover all such equivalents. Incorporation by Reference

[0149] References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes.

[0150] Equivalents

[0151] Various modifications of the invention and many further embodiments thereof, in addition to those shown and described herein, will become apparent to those skilled in the art from the full contents of this document, including references to the scientific and patent literature cited herein. The subject matter herein contains important information, exemplification and guidance that can be adapted to the practice of this invention in its various embodiments and equivalents thereof.

Claims

Claims1. A system for providing a projected ablation lesion depth, the system comprising: a console configured to be operably associated with an ultrasound imaging device and exchange data therewith, wherein the console comprises a hardware processor coupled to non- transitory, computer-readable memory containing instructions executable by the processor to cause the console to: receive and analyze three-dimensional (3D) ultrasound image data from an ultrasound imaging device, the 3D ultrasound image data being associated with an anatomical region of interest in which an ablation catheter is positioned, said ablation catheter comprising at least one electrode comprising an electrode tip; and calculate a position and orientation of the ablation catheter and the electrode tip in relation to a targeted tissue within the anatomical region of interest, whereby a distance of the electrode tip from the targeted tissue is calculated and a contact point of the electrode with the targeted tissue is determined based on said calculated distance.

2. The system of claim 1, wherein the instructions executable by the processor further cause the console to calculate, using the 3D ultrasound image data and the contact point, a measurement of thickness of the targeted tissue proximate to the electrode tip.

3. The system of claim 2, wherein the instructions executable by the processor further cause the console to calculate, using the targeted tissue thickness measurement, a Tailored Ablation Index (TAI) value for a projected ablation lesion depth.

4. The system of claim 3, wherein the TAI is calculated using the tissue thickness measurement and one or more ablation catheter parameters.

5. The system of claim 4, wherein the one or more ablation catheter parameters comprises one or more of power (P), time (d), and contact force (DF) of the ablation electrode.

6. The system of claim 1, wherein calculating a position and orientation of the ablation catheter comprises receiving data from one or more positional sensors.

7. The system of claim 1, wherein the 3D ultrasound image data comprises 3D image data obtained from an intracardiac echography (ICE) catheter.

8. The system of claim 1, further comprising running, via the console, one or more imaging algorithms configured to analyze the 3D ultrasound image data and identify one or more anatomical structures of interest, wherein at least one algorithm comprises a segmentation algorithm.

9. The system of claim 8, wherein the one or more imaging algorithms are configured to calculate the position and orientation of the ablation catheter relative to a targeted tissue within a heart anatomy such that an exact position of the ablation catheter and the electrode tip relative to the targeted tissue is identified.

10. The system of claim 9, wherein a distance from a heart wall is measured from the electrode tip, wherein the tissue thickness measurement is a cardiac wall thickness measurement.

11. The system of claim 10, wherein the cardiac wall thickness measurement is combined with a regression formula to calculate the projected lesion depth.

12. The system of claim 9, wherein the processor further causes the console to determine, during an ablation procedure, whether a created lesion depth is sufficient to treat a condition.

13. The system of claim 12, wherein determining whether a created lesion depth is sufficient comprises applying one or more thresholds to the calculated TAI value, wherein the one or more thresholds vary between anatomical regions in the heart.

14. The system of claim 13, wherein the anatomical regions of the heart are identified and the TAI threshold is automatically provided via the one or more algorithms.

15. The system of claim 14, wherein the console is further configured to output, via a display, visualization of the anatomical region of interest as a 3D model, wherein the output includes visualization of the identified position of the ablation catheter tip within the anatomical region of interest.

16. The system of claim 15, wherein the output provides feedback to a user as one or more of a guidance to achieve the contact point of the electrode tip with the targeted tissue, a distance from the electrode tip to the targeted tissue, and / or the sufficiency of the created lesion depth.

17. The system of claim 16, wherein the sufficiency of the created lesion depth comprises an indicator configured to indicate that the created lesion depth is sufficiently transmural.

18. The system of claim 17, wherein indicator comprises one or more of a color, a shape, a texture, and a shading configured to indicate that the created lesion depth is sufficiently transmural.

19. The system of claim 1, wherein the console processor is configured to receive the 3D image data in real-time or near real-time from a field-of-view sufficient to capture the anatomical region of interest and to reconstruct the 3D image in real-time or near real-time.

20. The system of claim 1, wherein the electrode comprises one or more of one or more splines with one or more of distinct electrodes, a spline electrode on a basket catheter, and one or more single electrodes on a point by point catheter.

21. A method for providing a projected ablation lesion depth, the method comprising: providing a console configured to be operably associated with an ultrasound imaging device and exchange data therewith; receiving and analyzing, via the console, three-dimensional (3D) ultrasound image data from an ultrasound imaging device, the 3D ultrasound image data being associated with an anatomical region of interest in which an ablation catheter is positioned, said ablation catheter comprising at least one electrode comprising an electrode tip; andcalculating a position and orientation of the ablation catheter and the electrode tip in relation to a targeted tissue within the anatomical region of interest, whereby a distance of the electrode tip from the targeted tissue is calculated and a contact point of the electrode with the targeted tissue is determined based on said calculated distance.

22. The method of claim 21, further comprising calculating, using the 3D ultrasound image data and the contact point, a measurement of thickness of the targeted tissue proximate to the electrode tip.

23. The method of claim 22, further comprising calculating, using the targeted tissue thickness measurement, a Tailored Ablation Index (TAI) value for a projected ablation lesion depth.

24. The method of claim 23, wherein the TAI is calculated using the tissue thickness measurement and one or more ablation catheter parameters.

25. The method of claim 24, wherein the one or more ablation catheter parameters comprise one or more of power (P), time (d), and contact force (DF) of the ablation electrode.

26. The method of claim 21, wherein calculating a position and orientation of the ablation catheter comprises receiving data from one or more positional sensors.

27. The method of claim 21, wherein the 3D ultrasound image data comprises 3D image data obtained from an intracardiac echography (ICE) catheter.

28. The method of claim 21, wherein analyzing the 3D ultrasound image data comprises running, via the console, one or more imaging algorithms configured to identify one or more anatomical structures of interest, wherein at least one algorithm comprises a segmentation algorithm.

29. The method of claim 28, wherein the one or more imaging algorithms are configured to calculate the position and orientation of the ablation catheter relative to a targeted tissue within aheart anatomy such that an exact position of the ablation catheter and the electrode tip relative to the targeted tissue is identified.

30. The method of claim 21, wherein a distance from a heart wall is measured from the electrode tip, wherein the tissue thickness measurement is a cardiac wall thickness measurement.

31. The method of claim 30, wherein the cardiac wall thickness measurement is combined with a regression formula to calculate the projected lesion depth.

32. The method of claim 31, further comprising determining, during an ablation procedure, whether a created lesion depth is sufficient.

33. The method of claim 32, wherein determining whether a created lesion depth is sufficient comprises applying one or more thresholds to the calculated TAI value, wherein the one or more thresholds vary between anatomical regions in the heart.

34. The method of claim 33, wherein the anatomical regions in the heart are identified and the TAI threshold is automatically provided via the one or more algorithms.

35. The method of claim 21, further comprising displaying a visualization of the anatomical region of interest as a 3D model, wherein the visualization includes the identified position of the ablation catheter tip within the anatomical region of interest.

36. The method of claim 35, wherein the output provides feedback to a user as one or more of a guidance to achieve the contact point of the electrode tip with the targeted tissue, a distance from the electrode tip to the targeted tissue, and / or the sufficiency of the created lesion depth.

37. The method of claim 36, wherein the sufficiency of the created lesion depth comprises an indicator configured to indicate that the created lesion depth is sufficiently transmural.

38. The method of claim 37, wherein indicator comprises one or more of a color, a shape, a texture, and a shading configured to indicate that the created lesion depth is sufficiently transmural.

39. The method of claim 21, wherein the console is configured to receive the 3D image data in real-time or near real-time from a field-of-view sufficient to capture the anatomical region of interest and to reconstruct the 3D image in real-time or near real-time.

40. The method of claim 21, wherein the electrode comprises one or more of one or more splines with one or more of distinct electrodes, a spline electrode on a basket catheter, and one or more single electrodes on a point by point catheter.

Images