Method, system, and GUI for enhanced real-time visual feedback of intraluminal catheter engagement

Abstract

To improve real-time visual feedback of intraluminal catheter engagement.SOLUTION: The subject matter disclosed herein includes computer systems, methods, and graphical user interfaces that provide graphical feedback indicating a real-time level of contact between a tissue wall of a luminal organ and an ablation catheter based on electrical impedance sensed by an electrode of the catheter. Since impedance is related to the proximity of the electrode to the tissue wall, the system utilizes the impedance measurement to visually alter the appearance of the graphical representation of the electrode in accordance with changes in the sensed impedance. The graphical feedback allows the physician to make real-time adjustments to the positioning of the catheter and the applied force, thereby improving the accuracy and effectiveness of intraluminal catheter therapy. The graphical feedback includes a plurality of contact lobes centered on the electrode and having a size that increases with the contact level.SELECTED DRAWING: Figure 1A

Description

[Technical Field]

[0001] The subject matter disclosed herein relates to visualization techniques for intraluminal catheter therapy in the diagnosis and treatment of medical disorders. [Background technology]

[0002] Intraluminal catheter therapy (ICT), or catheterization, has become an extremely important tool in the medical field for both the diagnosis and treatment of various medical disorders. This minimally invasive procedure involves guiding a long, thin, flexible tube, or catheter, into a hollow organ. Catheters equipped with electrodes are used, among other things, to map the organ and identify precise locations associated with abnormal medical conditions.

[0003] Cardiac ICT, a specific example of ICT, is an important tool for both the diagnosis and treatment of cardiac disorders, particularly arrhythmias. It involves inserting an electrode-equipped catheter into the heart through blood vessels and using the catheter to generate a map of the heart's electrical activity and pinpoint the exact location of the abnormal electrical activity. The identified site can then be treated through ablation, where targeted energy neutralizes the abnormal tissue and restores normal heart rhythm. This integrated approach has revolutionized cardiac treatment, offering patients a less invasive option with a shorter recovery time. Summary of the Invention [Means for solving the problem]

[0004] Important aspects of catheterization in the context of cardiology relate to tissue contact and ablation accuracy. Ensuring proper contact between the distal catheter tip assembly (e.g., balloon and / or basket) and the cardiac tissue is critical for accurate and effective results.

[0005] Physicians manipulating catheters benefit from knowing the level of contact between the catheter and the tissue wall—in other words, how much force is being applied to the tissue wall. The force distribution on the distal tip assembly can help physicians precisely steer the tip. Furthermore, when manipulating the catheter, it is desirable to avoid applying excessive force to the tissue, as this can cause deformation of the tissue surface, e.g., tenting, resulting in an inefficient treatment. An indication of the force being applied to the tissue wall is also useful during various other procedures, such as pulsed field ablation (PFA). Too little contact can result in ineffective ablation, while too much pressure can cause excessive tissue damage. An indication of the proximity between the catheter and tissue can help physicians reach a threshold level of force to achieve a desired lesion depth.

[0006] The subject matter disclosed herein includes computer systems, methods, and graphical user interfaces that provide graphical feedback indicating real-time proximity based on electrical impedance sensed by electrodes on a catheter. Because impedance relates to the proximity of the electrodes to the tissue wall, the system utilizes impedance measurements to visually change the appearance of the graphical representation of the electrodes according to changes in sensed impedance. The graphical feedback allows the physician to make real-time adjustments to the catheter positioning and applied force, thereby improving the accuracy and effectiveness of ICT. For example, if the impedance suggests inadequate contact, the physician may reposition the catheter to achieve better engagement with the tissue. Conversely, a high impedance reading can signal excessive pressure, prompting the physician to reduce contact force to prevent tenting and / or potential tissue damage.

[0007] The problem addressed by this disclosure is achieving a balance between high-detail visualization and a sufficiently simple structure of the visual elements. This problem is solved in this disclosure by using "contact lobes" formed by curves overlaid on a rendering of the catheter and positioned at optimal distance ranges. The size of these contact lobes indicates the level of contact. Additionally, the contact lobes are designed to be easily distinguishable from one another. [Brief explanation of the drawings]

[0008] In order to better understand the subject matter disclosed herein and to illustrate how it may be carried out in practice, embodiments will now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which: [Figure 1A] 1 illustrates a catheter-based electrophysiological mapping and ablation system according to an embodiment of the subject matter disclosed herein. [Figure 1B] 1 shows a flowchart illustrating a computer-implemented method according to an embodiment of the present disclosure. [Figure 1C] 10A and 10B schematically illustrate transverse and tangential directions according to an embodiment of the present invention. [Figure 2A] 10A-10C illustrate various contact lobes according to an embodiment of the present disclosure. [Figure 2B] 10A-10C illustrate various contact lobes according to an embodiment of the present disclosure. [Figure 2C] 10A-10C illustrate various contact lobes according to an embodiment of the present disclosure. [Figure 2D] 10A-10C illustrate various contact lobes according to an embodiment of the present disclosure. [Figure 2E] 10A-10C illustrate various contact lobes according to an embodiment of the present disclosure. [Figure 2F] 10A-10C illustrate various contact lobes according to an embodiment of the present disclosure. [Figure 3A] 10A-10C schematically illustrate merging of non-adjacent contact lobes according to an embodiment of the present disclosure. [Figure 3B]10A-10C schematically illustrate merging of non-adjacent contact lobes according to an embodiment of the present disclosure. [Figure 3C] 10 shows a schematic representation of the interior according to an embodiment of the present disclosure. [Figure 3D] 10 shows a schematic representation of the interior according to an embodiment of the present disclosure. [Figure 3E] 10 shows a schematic representation of the interior according to an embodiment of the present disclosure. [Figure 4A] 10A and 10B schematically illustrate transverse and tangential radii according to an embodiment of the present disclosure. [Figure 4B] 10A and 10B illustrate schematic diagrams of bending of contact lobes according to embodiments of the present disclosure. [Figure 5A] 10A-10C illustrate exemplary screenshots of visual outputs of methods and systems according to embodiments of the present disclosure. [Figure 5B] 10A-10C illustrate exemplary screenshots of visual outputs of methods and systems according to embodiments of the present disclosure. [Figure 5C] 10A-10C illustrate exemplary screenshots of visual outputs of methods and systems according to embodiments of the present disclosure. [Figure 5D] 10A-10C illustrate exemplary screenshots of visual outputs of methods and systems according to embodiments of the present disclosure. [Figure 6] 1 shows a block diagram that schematically illustrates a system according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0009] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be understood by those skilled in the art that the subject matter disclosed herein may be practiced without these specific details. In other instances, well-known methods and features have not been described in detail so as not to obscure the subject matter disclosed herein.

[0010] Unless specifically stated otherwise, as will be apparent from the following description, it is understood that throughout this specification, descriptions utilizing terms such as "processing," "calculating," "updating," "rendering," and the like refer to computer operations and / or processes that manipulate and / or transform data into other data, where the data is represented as physical quantities, such as electronic quantities, and / or where the data represents physical objects. The term "computer" should be interpreted expansively to encompass any type of hardware-based electronic device having data processing capabilities. Processing capabilities may include processing circuitry. Each processing circuitry may comprise, for example, one or more processors operably connected to computer memory (including non-transitory) loaded with executable instructions for performing operations, as further described below.

[0011] The one or more processors referred to herein may represent one or more general-purpose processing devices, such as, for example, a microprocessor, a central processing unit, etc. More specifically, a given processor may be one of a complex instruction set computing (CISC) microprocessor, a reduced instruction set computing (RISC) microprocessor, a very long instruction word (VLIW) microprocessor, a processor implementing other instruction sets, or a processor implementing a combination of instruction sets. The one or more processors may also be one or more special-purpose processing devices, such as an application specific integrated circuit (ASIC), a field programmable gate array (FPGA), a digital signal processor (DSP), a graphics processing unit (GPU), a network processor, etc.

[0012] The various illustrative logic blocks, modules, and algorithm steps described in connection with the embodiments disclosed herein may be implemented as electronic hardware, computer software, or a combination of both. To clearly illustrate this interchangeability of hardware and software, the various illustrative components, blocks, modules, and steps have been described generally in terms of their functionality. Whether such functionality is implemented as hardware or software depends on the particular application and design constraints imposed on the overall system. The described functionality may be implemented in various ways for each particular application, and such implementation decisions should not be interpreted as causing any departure from the scope of the present disclosure.

[0013] It will also be understood that a system according to the present disclosure may be implemented, at least in part, on a suitably programmed computer. Similarly, the present disclosure contemplates a computer program readable by a computer for performing the methods of the present disclosure. The present disclosure further contemplates a non-transitory computer-readable memory tangibly embodying a program of instructions executable by a computer for performing the methods of the present disclosure.

[0014] 1A, which illustrates an exemplary catheter-based electrophysiology mapping and ablation system 10. System 10 includes multiple catheters that are inserted percutaneously by a physician 24 through a patient's vascular system into the chambers or vasculature of heart 12. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location in heart 12. A catheter can then be inserted into the delivery sheath catheter to reach the desired location within heart 12.

[0015] The multiple catheters may include catheters dedicated to sensing intracardiac electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. Exemplary catheters 14 configured for ablating tissue and / or sensing and / or mapping electrical cardiac activity are shown herein. A physician 24 may position a distal tip 28 of the catheter 14 in contact with the epicardial tissue surface for sensing and / or ablation.

[0016] The catheter 14 is an exemplary catheter comprising a distal assembly and having one, and preferably multiple, electrodes 66, optionally distributed across multiple frame elements 62 at the distal tip 28. The electrodes are generally configured to deliver ablation energy to tissue and / or sense cardiac electrical signals. The catheter 14 additionally includes one or more position sensors 70 embedded at or near the distal tip 28 to track the position and orientation of the distal tip 28. Optionally and preferably, the position sensor 70 is a magnetic-based position sensor, such as a position sensor including three magnetic coils for sensing three-dimensional (3D) position and orientation, or a position sensor including one magnetic coil for sensing a single direction.

[0017] Each magnetic-based position sensor 70 may operate in conjunction with a location pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the distal tip 28 of the catheter 14 may be tracked based on the magnetic fields generated by the location pads 25 and sensed by the magnetic-based position sensors 70. Details of magnetic-based position sensing technology are described in U.S. Patent Nos. 5,5391,199; 5,443,489; 5,558,091; 6,172,499; 6,239,724; 6,332,089; 6,484,118; 6,618,612; 6,690,963; 6,788,967; and 6,892,091.

[0018] The system 10 includes one or more electrode patches 38 positioned for skin contact on the patient 23 to establish a location reference for the location pads 25 and impedance-based tracking of the electrodes 66. For impedance-based tracking, current is directed to the electrodes 66 and sensed at the electrode skin patches 38, thereby allowing the location of each electrode to be triangulated through the electrode patches 38. Details of impedance-based location tracking technology are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182.

[0019] Recorder 11 records and displays electrograms 21 acquired by body surface ECG electrodes 18 and, optionally, cardiac signals acquired by electrodes 66 of catheter 14. Recorder 11 may include pacing capability for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.

[0020] The system 10 may include an ablation energy generator 50 adapted to deliver ablation energy to an electrode 66 of a distal assembly at the distal tip of the catheter. The energy generated by the ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy or pulsed-field ablation (PFA) energy, including unipolar or bipolar high-voltage direct current pulses, such as may be used to produce irreversible electroporation (IRE).

[0021] Patient interface unit (PIU) 30 is an interface configured to establish electrical communication between at least one catheter and other catheters, other electrophysiology equipment, a power source, and a workstation 55 for controlling the operation of system 10. The electrophysiology equipment of system 10 may include, for example, multiple catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, PIU 30 additionally includes processing capabilities for implementing real-time calculations of catheter location and performing ECG calculations.

[0022] The workstation 55 includes a processor unit having memory, a memory or storage device having appropriate operating software stored therein, and user interface capabilities. The workstation 55 may optionally provide multiple functions, including: (1) modeling the endocardial anatomical structure in three dimensions (3D) and rendering the model or anatomical map 20 for display on the display device 27; (2) displaying activation sequences (or other data) compiled from recorded electrograms 21 in a representative visual representation or image superimposed on the rendered anatomical map 20 on the display device 27; (3) displaying the real-time location and orientation of at least one catheter within the cardiac chamber; and (4) displaying a target site, such as where ablation energy is applied, on the display device 27. One commercially available product embodying elements of the system 10 is available as the CARTO™ 3 System, commercially available from Biosense Webster, Inc., 31A Technology Drive, Irvine, CA 92618.

[0023] In some examples, an irrigation module is provided for delivering irrigation fluid, such as saline, to the treatment site. The irrigation module may include a pump and an associated fluid reservoir.

[0024] Reference is made to FIG. 1B, which illustrates a flowchart illustrating a computer-implemented method 100 according to an embodiment of the present disclosure. Method 100 can be used to provide real-time visual feedback, i.e., with negligible time delay. The visual feedback can be visual feedback of the contact level between the tissue wall of the luminal organ and an ablation catheter (e.g., catheter 14 shown in FIG. 1A). The catheter can include multiple electrodes that can be positioned along the catheter distal assembly. The multiple electrodes can form an elongated electrode array.

[0025] In some embodiments, the plurality of electrodes may form a planar electrode array. For example, the catheter distal assembly may include a single surface on which electrodes may be disposed. In some embodiments, all electrodes included in the plurality of electrodes may form a linear array. For example, a single electrode may be included in each frame element.

[0026] Method 100 may be performed while the catheter distal assembly is within a luminal organ of a patient. In some embodiments, the luminal organ may be the patient's heart or a portion thereof.

[0027] The method 100 may include rendering 105 a graphical representation of the catheter distal assembly and the plurality of electrodes thereon on a display. In some embodiments, the method 100 may include rendering 107 an anatomical structure of the luminal organ on a display.

[0028] Method 100 may include repeatedly assessing tissue proximity 110. In some embodiments, repeatedly assessing tissue proximity 110 may include repeatedly measuring the impedance of at least one electrode 112. In other words, a predetermined number of impedance measurements may be performed over a predetermined period of time. Preferably, the impedance of each of a plurality of electrodes may be repeatedly measured.

[0029] In some embodiments, method 100 may include step 115 of measuring the position of at least one electrode. Preferably, the position of each of multiple electrodes may be measured. Step 115 of measuring the position of at least one electrode may be required, for example, if the catheter is manipulated such that at least one electrode moves from a known position. In some embodiments, step 115 of measuring the position may be performed before step 110 of repeatedly measuring the impedance of at least one electrode.

[0030] The method 100 may include a step 120 of dynamically updating the visual features. The visual features may be indicative of the measured impedance. In other words, the visual features may be updated according to the measured impedance. The updating may be performed as soon as a measurement is received. The updating may be performed each time an impedance measurement is received. The step 120 of dynamically updating the visual features may include performing steps or routines according to the exact nature of the visual features. Routines and visual features are described further herein below.

[0031] The visual features may include multiple contact lobes. A contact lobe may be a line segment having visual characteristics indicative of the level of contact between the tissue wall and the catheter distal assembly. A contact lobe may correspond to multiple electrodes along the catheter distal assembly. The contact lobes may be distinct; that is, the line segments forming the contact lobes may be configured such that each contact lobe can be easily distinguished from adjacent contact lobes by a person viewing a rendering of the contact lobes, such as a physician manipulating the catheter. Note that, as described herein below, the contact lobes may form a continuous contour.

[0032] The size of the contact lobe may increase with the level of contact between the tissue wall and the corresponding electrode based on the measured impedance. For example, the contact lobe may have an arcuate geometry. The size of the contact lobe may be the radius of the circle on which the contact lobe is based and / or the length of the arc.

[0033] It should be noted that the size of a contact lobe may be the length of a particular geometric feature of the contact lobe. In other words, the shape of the contact lobe may be variable. For example, the contact lobes may have the geometric shape of an elliptical arc. Their size may be the length of one of the semi-major or semi-minor axes. In some embodiments, one axis may be constant. That is, if the size is the length of the major axis, the minor axis may be constant. If the size is the length of the semi-minor axis, the semi-major axis may be constant.

[0034] 1C, which schematically illustrates transverse and tangential directions, according to an embodiment of the present invention. The catheter distal assembly 1110 may define a tangential direction 1120 and a transverse direction 1130. The tangential direction 1120 may be along a local orientation of the catheter distal assembly 1110. In other words, the tangential direction 1120 may be along a line tangent to the contour of the catheter distal assembly 1110. The transverse direction 1130 may be substantially perpendicular to the tangential direction 1120.

[0035] 2A, which schematically illustrates exemplary contact lobes according to an embodiment of the present disclosure. A catheter distal assembly 220, which may be positioned inside an intraluminal organ 210, may be rendered on a display. The catheter distal assembly 220 may include multiple electrodes 231, 232, 233, and 234. For each electrode, a corresponding contact lobe is rendered. That is, contact lobe 241 may correspond to electrode 231, contact lobe 242 may correspond to electrode 232, contact lobe 243 may correspond to electrode 233, and contact lobe 244 may correspond to electrode 234. Contact lobes 241, 242, 243, and 244 may be overlaid on a graphical representation of the catheter distal assembly 220.

[0036] Contact lobes 241, 242, 243, and 244 may each be centered over a corresponding electrode. That is, the line segments forming contact lobes 241, 242, 243, and 244 may be configured such that each contact lobe can easily indicate its corresponding electrode by a person viewing a rendering of the contact lobe, such as a physician manipulating the catheter. For example, contact lobes 241, 242, 243, and 244 may have an axis of symmetry. The axis of symmetry may pass through the corresponding electrode. In some embodiments, the axis of symmetry may pass near the corresponding electrode. In some embodiments, the axis of symmetry may be parallel to the transverse direction of distal assembly 220.

[0037] The contact lobes 241, 242, 243, and 244 may follow the contour of the graphical representation of the catheter distal assembly 220. In other words, for each of the contact lobes 241, 242, 243, and 244, an axis defining the longitudinal extent of the contact lobe may be parallel to a tangent direction of the catheter distal assembly 220. For example, the contact lobes 241, 242, 243, and 244 may be elliptical segments. In other words, the contact lobes 241, 242, 243, and 244 may have the geometry of an elliptical arc. The axis of the ellipse (i.e., the major axis or the minor axis) may be parallel to a tangent direction of the catheter distal assembly 220.

[0038] Contact lobes 241, 242, 243, and 244 may be positioned on one side of catheter distal assembly 220. The side of catheter distal assembly 220 on which contact lobes 241, 242, 243, and 244 may be positioned may represent the side of organ 210 contacted by multiple electrodes 231, 232, 233, and 234. In other words, parallel transverse lines connecting points on a contact lobe to corresponding electrodes may pass through the side of organ 210 contacted by the electrode, but may not pass through the side of organ 210 not contacted by the electrode.

[0039] Reference is now made to Figure 2B, which schematically illustrates another exemplary contact lobe according to an embodiment of the present disclosure. The embodiment shown in Figure 2B adds contact lobes 251, 251, 253, and 254 to the embodiment shown in Figure 2A. For brevity, reference numerals for elements already mentioned in the description of Figure 2A are not shown in Figure 2B. Contact lobe 251 corresponds to electrode 231, contact lobe 252 corresponds to electrode 232, contact lobe 253 corresponds to electrode 233, and contact lobe 254 corresponds to electrode 234. Contact lobes 251, 251, 253, and 254 may be positioned on a side of catheter distal assembly 220 opposite to the side on which contact lobes 241, 242, 243, and 244 may be positioned.

[0040] In some embodiments, the contact lobes may be configured to expand asymmetrically relative to the central axis of the catheter distal assembly so as to extend primarily transversely toward the tissue wall. In other words, contact lobes 241, 242, 243, and 244 may have a larger size than contact lobes 251, 251, 253, and 254.

[0041] As indicated hereinabove, the contact lobes may form a continuous contour. In other words, at least two contact lobes may intersect or share a common point. Preferably, in some embodiments, all contact lobes may form a continuous contour. See FIG. 2C, which schematically illustrates yet another exemplary contact lobe forming a continuous contour, according to an embodiment of the present disclosure. Contact lobes 261, 262, 263, and 264 may form a continuous contour.

[0042] In other words, contact lobes that may form a continuous contour may be described as merging into a single region. Note, however, that merged contact lobes may include contact lobes that form discontinuous contours, as described herein below.

[0043] Some elements and settings shown in Figure 2C may be similar to those shown in Figure 2A, and therefore, for the sake of brevity, reference numbers for elements already referenced in the description of Figure 2A are not shown in Figure 2C.

[0044] In embodiments in which the contact lobes may form a continuous contour, the contact lobes may include multiple intersection regions. The intersection regions may distinguish the contact lobes. See FIG. 2D, which schematically illustrates intersection regions. An intersection region 2265a may be formed between contact lobes 2261 and 2262. An intersection region 2265b may be formed between contact lobes 2262 and 2263. The intersection region 2265a may include a vertex 2266a. The intersection region 2265b may include a vertex 2266b. An vertex may be an abrupt change in the direction of the continuous contour formed by the contact lobes, such as a notched saddle or a pointed depression. In another example, an vertex may be a point where the parameterization of the coordinates of the points of the contour formed by the contact lobes may allow for discontinuous derivatives as a function of some parameters. In some embodiments, the derivative of the parameterization of any coordinate of the contour point may have a magnitude (absolute value) greater than a predetermined threshold. The apex may help distinguish between contact lobes.

[0045] In some embodiments, the presence of a vertex may depend on the measured impedance. For example, if the measured impedance of an adjacent electrode is above a predetermined threshold, the contact lobes corresponding to the adjacent electrode may form a vertex at the intersection region.

[0046] Note that rendering vertices may not require the calculation of derivatives. For example, intersections between contact lobes may be calculated. Contact lobes may be separated by intersections. In other words, sections of contact lobes (e.g., section 2267a shown with dashed lines) may be removed.

[0047] In some embodiments, a boundary line may be included in the intersection region to help distinguish between contact lobes (e.g., boundary line 2267b included in intersection region 2265b). Note that the boundary line characteristics may be independent of the vertex characteristics.

[0048] 2E, which schematically illustrates yet another exemplary contact lobe according to an embodiment of the present disclosure. The contact lobe may include an infill 270, i.e., a color shading of an area extending between the rendering of the contact lobe and the rendering of the catheter distal assembly. In some embodiments, the infill area may extend between the rendering of the contact lobe and the rendering of the organ. The infill may be transparent. That is, the color shading may not obscure visual features to which the infill is applied. For example, if the infill is applied to an area that includes part of the rendering of an organ, some structures of the organ may be visible. In some embodiments, the color of the infill may be the same as the color of the contact lobe. In some embodiments, the color of the infill may be gradient. In other words, the color of the infill may change gradually. Note that the characteristics of the infill may be independent of the characteristics of the contact lobe, forming a continuous contour.

[0049] See FIG. 2F, which schematically illustrates variable coloring of contact lobes. In some embodiments, the color of a contact lobe may depend on the measured impedance value of the corresponding electrode. For example, contact lobe 282 may be colored a first color (shown as a dashed line), while contact lobe 283 may be colored a second color (shown as a continuous line). The coloring of contact lobes 282 and 283 may indicate that the contact level is above or below a particular threshold. In other words, the first color may indicate that the contact level is below a minimum threshold, and the second color may indicate that the contact level is above the minimum threshold.

[0050] Some elements and settings shown in Figures 2E-2F may be similar to those shown in Figure 2C, and therefore, for the sake of brevity, reference numbers for elements already referenced in the description of Figure 2C are not shown in Figures 2E-2F.

[0051] 3A-3B, which schematically illustrate merging of non-adjacent contact lobes according to an embodiment of the present disclosure. A catheter distal assembly 320, which may be positioned inside an intraluminal organ 310, may be rendered on a display. The catheter distal assembly 320 may include multiple electrodes 331, 332, and 333. The contact lobes corresponding to electrodes 331 and 333 may not be adjacent. That is, corresponding electrodes 331 and 333 may not be nearest neighbors in an array of electrodes or adjacent in a linear array of electrodes. For each electrode, a corresponding contact lobe is rendered. That is, contact lobe 341 may correspond to electrode 331, contact lobe 342 may correspond to electrode 332, and contact lobe 343 may correspond to electrode 333. The contact lobes may be overlaid on a graphical representation of the catheter distal assembly 320.

[0052] The contact lobes corresponding to electrodes 331 and 333 may be merged. Note that merging non-adjacent contact lobes may result in a discontinuous contour. This may be in contrast to the merging of adjacent contact lobes described herein above. For example, the contour of contact lobe 341 may be divided into two discontinuous segments 341a and 341b, and the contour of contact lobe 343 may be divided into two discontinuous segments 343a and 343b. Intersection region 365 may include vertex 367a formed between segments 341a and 343a and vertex 367b formed between segments 341b and 343b.

[0053] For example, merging of non-adjacent contact lobes may be required if the catheter distal assembly 320 is sharply bent, eg, if the catheter distal assembly 320 may have a "U-turn."

[0054] Note that in FIG. 2A, the contact lobes are "outside" the catheter distal assembly, while in FIG. 3A, they are "inside" the catheter distal assembly. In other words, in FIG. 2A, the contact lobes are positioned outside the catheter distal assembly, while in FIG. 3A, the contact lobes are positioned inside the catheter distal assembly. See FIGS. 3C-3E, which schematically illustrate the inside according to an embodiment of the present disclosure. The "inside" and "outside" of a segment of the catheter distal assembly 3700 can be defined in two ways. The outside can be defined as any area not included in the inside.

[0055] 3C, which shows a schematic representation of the medial side according to the first definition. According to the first definition, the medial side may be the region 3720 bounded by the cord line 3710 between two points on the segment and the catheter distal assembly 3700. The region 3720 is indicated by downward diagonal stripes.

[0056] 3D, which shows a schematic representation of the medial side according to the second definition. According to the second definition, the medial side 3730 may be where a displacement along the transverse direction forms an acute angle with a local curvature vector, such as local curvature vector 3735. Region 3730 is indicated by upward diagonal stripes.

[0057] It should be noted that the above two definitions (of inner) are not necessarily mutually exclusive. As shown in FIG. 3E, region 3740 may be included in the inner according to both the first and second definitions. In other words, region 3740 may be included in regions 3720 and 3730. Region 3740 is indicated by intersecting diagonal lines. In other words, region 3740 is indicated by both downward diagonal stripes (marking region 3720) and upward diagonal stripes (marking region 3730).

[0058] Depending on the segment, any of these definitions can be used to define the inside and outside of the catheter distal assembly. In some embodiments, a method disclosed herein (e.g., method 100) can include selecting a definition of inside for at least one segment of the catheter distal assembly. In some embodiments, selecting the definition of inside can be performed dynamically, i.e., according to calculations performed in real time based on measured positions of electrodes included in the catheter distal assembly.

[0059] In some embodiments, the contact lobes may be positioned only on the outside of the catheter distal assembly. The contact lobes do not necessarily indicate the side of the organ in contact with the electrode. In embodiments in which the contact lobes extend asymmetrically relative to the central axis of the catheter, they may extend outward. Positioning the contact lobes on the outside, or extending them asymmetrically outward, may allow for larger contact lobes and improve visualization of the contact level.

[0060] Refer to FIG. 4A, which schematically illustrates a transverse radius and a tangential radius, according to an embodiment of the present disclosure. A catheter distal assembly 420 may have an electrode 430. The catheter distal assembly 420, the electrode 430, and a contact lobe 440 may be rendered on a display. The contact lobe 440 may be an ellipse segment. In other words, the contact lobe 440 may have the geometry of an ellipse arc. In other words, the contact lobe 440 may be a line segment of an ellipse 450. The ellipse 450 may not be rendered on a display. The contact lobe 440 may be oriented along a tangential direction of the catheter distal assembly. In other words, the ellipse 450 may have two axes, a major axis and a minor axis. One axis (e.g., the major axis) may be parallel to the tangential direction. The other axis (e.g., the minor axis) may be parallel to the transverse direction. The half of the axis parallel to the tangential direction may be referred to as the "tangential radius." A tangential radius may extend along the tangential direction. A tangential radius may have a length r1. Half of an axis parallel to the transverse direction may be referred to as a "transverse radius." A transverse radius may extend along the transverse direction. A transverse radius may have a length r2. Similarly, an axis parallel to the tangential direction may be referred to as a "tangential diameter," and an axis parallel to the transverse direction may be referred to as a "transverse diameter."

[0061] In some embodiments, the tangent radius may be constant. In some embodiments, the tangent radius may be based on the spacing between electrodes of the electrode array. In some embodiments, the tangent radius may be equal to half the sum of the distances to adjacent electrodes along the catheter distal assembly. In other words, the tangent radius may be equal to the average separation of electrodes corresponding to nearby electrodes, where the separation may be measured along the catheter distal assembly.

[0062] Refer to FIG. 4B, which schematically illustrates bending of a contact lobe, according to an embodiment of the present disclosure. In some embodiments, where a contact lobe may include elliptical segments, some of the elliptical segments may be bent according to the curvature of the catheter distal assembly 475. The contact lobe 445 may have the shape of a bent elliptical segment. Each point of the contact lobe 445 may have a distance 470 from the catheter distal assembly 475, which may be equal to the distance 460 between the tangent radius of a regular (unbent) ellipse 450 and a corresponding point on the edge of the ellipse. In other words, the tangent diameter of the ellipse 450 may be bent according to the curvature of the catheter distal assembly 475, while maintaining the local half-thickness of the ellipse 450. In further words, a point on the ellipse 450 may be a distance 470 from the tangent diameter.

[0063]

number

[0064]

number

[0065]

number

[0066] See FIG. 1A . Dynamically updating visual features 120 may include calculating 125 the size of the contact lobe. In some embodiments, if the contact lobe may include an elliptical segment, calculating 125 the size of the contact lobe may include calculating 130 the radius of the elliptical segment (e.g., tangential radius and transverse radius). In embodiments in which the transverse radius may be calculated, the transverse radius may be variable. The transverse radius may be based on the level of contact between the tissue wall and the electrode. As described herein above, the transverse radius may extend transversely to the local orientation of the catheter distal assembly around the (corresponding) electrode.

[0067] In some embodiments, the variable transverse radius may vary within a radius adjustment range bounded by a minimum radius threshold value and a maximum radius threshold value. In other words, the variable transverse radius may have a minimum value and a maximum value. In some embodiments, the minimum radius threshold may correspond to a zero contact level. In other words, the minimum radius threshold may correspond to a no-contact level condition between the tissue wall and the electrode.

[0068] In some embodiments, dynamically updating 120 the visual features may include determining 140 the color of the contact lobe (eg, according to the contact level, as described herein above).

[0069] In some embodiments, dynamically updating visual features step 120 may include calculating the orientation of the contact lobes step 150. For example, as described herein above, the orientation of the contact lobes may be along the tangential direction. However, it should be noted that the orientation of the contact lobes may not be limited to the transverse direction. Calculating the orientation of the contact lobes step 150 may include, for example, calculating line parameters of a line that defines the longitudinal extent of the contact lobes.

[0070] In some embodiments, dynamically updating visual features step 120 may include merging contact lobes step 160. In some embodiments, merging contact lobes step 160 may include calculating intersections between contact lobes step 165.

[0071] In some embodiments, merging contact lobes 160 may include calculating vertices between the contact lobes 170. Calculating vertices 170 may include determining whether a vertex may be included. In some embodiments, calculating vertices 170 may include comparing the transverse radius to adjacent transverse radii of adjacent electrodes. If the difference between the transverse radius and the adjacent transverse radius is below a predetermined comparison threshold, the local transverse radius at the intersection may be smaller than the transverse radius by a predetermined dip threshold. In other words, the intersection may be closer to the catheter distal assembly than the transverse radius by at least the predetermined threshold.

[0072] In some embodiments, dynamically updating visual features 120 may include calculating 175 local transverse radii. Calculating 175 local transverse radii may include calculating, for each contact lobe, multiple local transverse radii at multiple corresponding locations according to tangential distances from the electrodes. In other words, distances from the catheter distal assembly or from a reference axis (e.g., an axis defining the longitudinal extent or an axis of an ellipse) may be calculated. In some embodiments, the local radii are calculated in distance increments of 0.5 millimeters. The distance increments may be distance increments along the catheter distal assembly.

[0073] In some embodiments, dynamically updating visual features step 120 may include calculating 180 curve vertices. In other words, coordinates of points of the contact lobe may be calculated. In some embodiments, the curve vertices may be the curve vertices of a polygon that approximates the exact shape of the contact lobe. For example, if the computer performing method 100 may need to approximate a curve with multiple straight lines, a polygon that approximates the exact shape of the contact lobe may be required.

[0074] In some embodiments, dynamically updating visual features step 120 may include calculating infill step 185. Calculating infill step 185 may include determining whether infill should be included. If infill is included, calculating infill step 185 may include calculating a desired color of the infill. Calculating infill step 185 may include calculating the transparency of the infill, e.g., the alpha channel in an RGBA color format.

[0075] In some embodiments, dynamically updating visual features step 120 may include providing the results of the calculations to a graphics engine 190 for rendering the contact lobes. In some embodiments, some of the calculations, such as calculating curve vertices step 180, may be performed by the graphics engine.

[0076] Refer to FIG. 5A, which shows an exemplary screenshot of a visual output of a method and system according to an embodiment of the present disclosure. A catheter distal assembly 510 comprising multiple electrodes (e.g., electrode 515) is rendered with multiple contact lobes, such as contact lobes 520, 530, 540, and 550. The contact lobes are rendered with dashed lines. The contact lobes extend asymmetrically relative to the central axis of the catheter distal assembly so that they extend primarily transversely toward the tissue wall. Contact lobes 520, 530, 540, and 550 are elliptical segments. Some of the contact lobes form a single contour. The contact lobes include infill.

[0077] 5B, which illustrates another exemplary screenshot of a visual output of a method and system according to an embodiment of the present disclosure. The contact lobes are rendered with dashed lines. Contact lobe 560 has one color, while contact lobe 570 has a second color. Different colors are shown as different types of dashes. Contact lobe 560 is an elliptical segment, while contact lobe 570 is not. Contact lobe 560 includes infill, while contact lobe 570 does not. Contact lobe 560 has a minimum transverse radius. Some of the contact lobes form a single contour.

[0078] 5C, which illustrates yet another exemplary screenshot of a visual output of a method and system according to an embodiment of the present disclosure. A catheter distal assembly 585 comprising multiple electrodes (e.g., electrode 590) is rendered with multiple contact lobes, such as contact lobes 595 and 598. The contact lobes are rendered with dashed lines. An organ 580 is also rendered. The contact lobes extend asymmetrically relative to the central axis of the catheter distal assembly so that they extend primarily transversely toward the tissue wall. Contact lobe 595 has a smallest transverse radius. Contact lobe 595 has one color, while contact lobe 598 has a second color. The different colors are indicated as different types of dashes. All contact lobes form a single outline.

[0079]

[0049] Reference is now made to Figure 5D, which illustrates yet another exemplary screenshot of a visual output of a method and system according to an embodiment of the present disclosure. A catheter distal assembly 5510 comprising multiple electrodes is rendered with multiple contact lobes, such as contact lobe 5520. The viewing position of the catheter distal assembly 5510 in Figure 5D is from the side, while the viewing position of the catheter distal assembly in Figures 5A-5C is from above. Note that the contact lobes may be three-dimensional objects, and each contact lobe may include multiple line segments (e.g., ellipse segments) that may be rendered on a display.

[0080]

[0041] Reference is now made to Figure 6, which shows a block diagram that schematically illustrates a system according to an embodiment of the present disclosure. Visualization system 600 may be configured to implement a method according to the present disclosure (e.g., method 100 shown schematically in Figure 1B) to provide real-time visual feedback of the contact level between the tissue wall of the luminal organ and the ablation catheter. System 600 may be, for example, a computer system.

[0081] The visualization system 600 may include a catheter rendering unit 605 for rendering the catheter distal assembly. The visualization system 600 may include an organ rendering unit 607 for rendering the organ in which the catheter distal assembly is positioned. The visualization system 600 may include a tissue proximity unit 610 for evaluating the proximity (contact level) of the electrodes to the tissue wall. The visualization system 600 may include an impedance measurement unit 612 for measuring the impedance of at least one electrode included in the catheter distal assembly. The visualization system 600 may include a position measurement unit 615 for measuring the position of the catheter distal assembly. The visualization system 600 may include a size unit 625 for calculating the size (e.g., transverse radius) of the contact lobes. The visualization system 600 may include an intersection unit 630 for calculating the intersection point between the contact lobes. The visualization system 600 may include a vertex unit 635 for determining whether a vertex may be required in the intersection region between the contact lobes and calculating the parameters of the vertex. The visualization system 600 may include a local radius unit 640 to calculate the local radius(s) of points of the contact lobe. The visualization system 600 may include a curve vertex unit 650 to calculate coordinates of points of the contact lobe. The visualization system 600 may include a color unit 660 to determine the color of the contact lobe. The visualization system 600 may include an infill unit 670 to determine whether the contact lobe contains infill. The visualization system 600 may include a GPU 680 to efficiently perform rendering calculations. The visualization system 600 may include a display 690 to display visual feedback.

[0082] overview The following is a non-exhaustive list of some exemplary embodiments of the present disclosure. The present disclosure also includes embodiments that include fewer than all of the features of an embodiment, and embodiments that use features from multiple embodiments, even if not listed below.

[0083] Example 1: A computer-implemented method for providing real-time visual feedback of the level of contact between a tissue wall of a luminal organ and an ablation catheter. The ablation catheter includes a plurality of electrodes forming an elongated electrode array disposed along a catheter distal assembly. The method includes rendering a graphical representation of the catheter distal assembly and the plurality of electrodes thereon on a display while the catheter distal assembly is within the luminal organ of the patient. The method includes, for each electrode of the plurality of electrodes, repeatedly assessing tissue proximity of each of the plurality of electrodes while the catheter distal assembly is within the luminal organ of the patient. Further, for each electrode of the plurality of electrodes, the method includes dynamically updating a visual feature indicative of tissue proximity. The visual feature includes a contact lobe, each contact lobe centered on a corresponding electrode and overlaid on the graphical representation of the catheter distal assembly, and a size of the contact lobe increasing with the level of contact between the tissue wall and the corresponding electrode based on tissue proximity.

[0084] Example 2: The computer-implemented method of Example 1, wherein assessing tissue proximity comprises measuring impedance of at least one electrode.

[0085] Example 3: The computer-implemented method of any one of Examples 1-2, wherein when the tissue proximity of adjacent electrodes exceeds a predetermined threshold, the contact lobes corresponding to the adjacent electrodes form a vertex at an intersection region.

[0086] Example 4: The computer-implemented method of any one of Examples 1-3, wherein the contact lobes are configured to expand asymmetrically relative to the central axis of the catheter so as to extend primarily transversely toward the tissue wall.

[0087] Example 5: The computer-implemented method of any one of Examples 3-4, comprising merging overlapping contact lobes corresponding to separate electrodes into a single region.

[0088] Example 6: The computer-implemented method of any one of Examples 1-5, wherein said contact lobe comprises an elliptical segment.

[0089] Example 7: The computer-implemented method of Example 6, comprising calculating, for each electrode, a variable transverse radius of the ellipse segment, the variable transverse radius being based on a contact level between the tissue wall and the electrode and extending transversely to a local orientation of the catheter around the electrode.

[0090] Example 8: The computer-implemented method of Example 7, comprising comparing the transverse radius to an adjacent transverse radius of an adjacent electrode. If the difference between the transverse radius and the adjacent transverse radius is below a predetermined comparison threshold, then the local transverse radius at the intersection is smaller than the transverse radius by a predetermined drop threshold.

[0091] Example 9: The computer-implemented method of any one of Examples 7-8, wherein the variable transverse radius varies within a radius adjustment range bounded by a minimum radius threshold value and a maximum radius threshold value.

[0092] Example 10: The computer-implemented method of example 9, wherein the minimum radius threshold corresponds to a zero contact level.

[0093] Example 11: The computer-implemented method of any one of Examples 6 to 10, wherein said ellipse segment includes a tangent radius extending in the direction of said local orientation of said catheter.

[0094] Example 12: The computer-implemented method of example 11, wherein said tangent radius is constant and is based on the spacing between electrodes of the electrode array.

[0095] Example 13: The computer-implemented method of any one of Examples 11-12, wherein the tangent radius is equal to half the sum of the distances to adjacent electrodes along the catheter.

[0096] Example 14: The computer-implemented method of any one of Examples 11 to 13, wherein the local orientation of the catheter around a given electrode is defined according to a tangent to the catheter distal assembly at the location of the given electrode.

[0097] Example 15: The computer-implemented method of any one of Examples 3-14, comprising merging overlapping contact lobes corresponding to separate electrodes into a single region.

[0098] Example 16: The computer-implemented method of any one of Examples 1-15, comprising using a transparent infill to color the contact lobes.

[0099] Example 17: The computer-implemented method of Example 16, wherein a first color indicates that the contact level is below a minimum threshold and a second color indicates that the contact level is above the minimum threshold.

[0100] Example 18: The computer-implemented method of any one of Examples 6 to 17, wherein the ellipse segments are curved according to the curvature of the catheter.

[0101] Example 19: The computer-implemented method of any one of Examples 1 to 18, comprising calculating, for each contact lobe, a plurality of local transverse radii at a corresponding plurality of locations according to tangential distance from the electrode.

[0102] Example 20: The computer-implemented method of example 19, wherein the local radii are calculated for distance increments of 0.5 millimeters.

[0103] Example 21: The computer-implemented method of any one of Examples 1 to 20, wherein the hollow organ is the patient's heart.

[0104] Example 22: The computer-implemented method of any one of Examples 1 to 21, wherein all electrodes included in the plurality of electrodes form a linear array.

[0105] Example 23: A computer-implemented method according to any one of Examples 1 to 22, comprising rendering an anatomical structure of a hollow organ on a display.

[0106] Example 24: A graphical user interface (GUI) for providing real-time visual feedback of the contact level between a tissue wall of a luminal organ and an ablation catheter. The ablation catheter includes a plurality of electrodes forming an elongated electrode array disposed along a catheter distal assembly. The GUI is executable by a computer to render a graphical representation of the catheter distal assembly and the plurality of electrodes thereon on a display while the catheter distal assembly is within the patient's luminal organ. The GUI is executable by a computer to repeatedly receive, for each electrode of the plurality of electrodes, a respective tissue proximity value for the plurality of electrodes while the catheter distal assembly is within the patient's luminal organ. Further, for each electrode of the plurality of electrodes, the GUI is executable by a computer to dynamically update a visual feature indicative of the tissue proximity value in response to detected changes in the tissue proximity value. The visual feature includes a contact lobe, each contact lobe centered on a corresponding electrode and overlaid on the graphical representation of the catheter distal assembly, and a size of the contact lobe increasing with the level of contact between the tissue wall and the corresponding electrode based on the tissue proximity value.

[0107] Example 25: A GUI as described in Example 24, wherein tissue proximity values ​​correspond to measured impedance values ​​of multiple electrodes.

[0108] Example 26: A GUI described in any one of Examples 24 to 25, wherein when the measured tissue proximity of adjacent electrodes exceeds a predetermined threshold, the contact lobes corresponding to said adjacent electrodes form a vertex at an intersection region.

[0109] Example 27: A GUI described in any one of Examples 24 to 26, wherein the contact lobes are configured to expand asymmetrically relative to the central axis of the catheter so as to extend primarily transversely toward the tissue wall.

[0110] Example 28: The GUI of any one of Examples 26-27, comprising merging overlapping contact lobes corresponding to separate electrodes into a single region.

[0111] Example 29: The GUI of any one of Examples 24-28, wherein said contact lobe comprises an elliptical segment.

[0112] Example 30: A GUI as described in Example 29, comprising calculating, for each electrode, a variable transverse radius of the ellipse segment, the variable transverse radius being based on the contact level between the tissue wall and the electrode and extending transversely to the local orientation of the catheter around the electrode.

[0113] Example 31: The GUI of Example 30, comprising comparing the transverse radius to an adjacent transverse radius of an adjacent electrode. If the difference between the transverse radius and the adjacent transverse radius is below a predetermined comparison threshold, then the local transverse radius at the intersection is less than the transverse radius by a predetermined drop threshold.

[0114] Example 32: A GUI according to any one of Examples 30-31, wherein the variable transverse radius varies within a radius adjustment range bounded by a minimum radius threshold value and a maximum radius threshold value.

[0115] Example 33: The GUI of Example 32, wherein the minimum radius threshold mentioned above corresponds to a zero contact level.

[0116] Example 34: A GUI described in any one of Examples 29 to 33, wherein said ellipse segment comprises a tangent radius extending in the direction of said local orientation of the catheter.

[0117] Example 35: A GUI as described in Example 34, wherein the tangent radius is constant and based on the spacing between electrodes of the electrode array.

[0118] Example 36: A GUI according to any one of Examples 34-35, wherein the tangent radius is equal to half the sum of the distances to adjacent electrodes along the catheter.

[0119] Example 37: A GUI as described in any one of Examples 34-36, wherein the local orientation of the catheter around a given electrode is defined according to a tangent to said catheter distal assembly at the location of the given electrode.

[0120] Example 38: The GUI of any one of Examples 26-37, comprising merging overlapping contact lobes corresponding to separate electrodes into a single region.

[0121] Example 39: The GUI of any one of Examples 24-38, comprising using a transparent infill to color the contact lobe.

[0122] Example 40: The GUI of Example 39, wherein a first color indicates a contact level below a minimum threshold and a second color indicates a contact level above the minimum threshold.

[0123] Example 41: A GUI according to any one of Examples 29 to 40, wherein the elliptical segments are curved according to the curvature of the catheter.

[0124] Example 42: The GUI of any one of Examples 24-41, comprising calculating, for each contact lobe, a plurality of local transverse radii at corresponding locations according to tangential distance from the electrode.

[0125] Example 43: The GUI described in Example 42, wherein the local radii are calculated for distance increments of 0.5 millimeters.

[0126] Example 44: The GUI of any one of Examples 24 to 43, wherein the hollow organ is the patient's heart.

[0127] Example 45: The GUI of any one of Examples 24 to 44, wherein all electrodes included in the plurality of electrodes form a linear array.

[0128] Example 46: A GUI described in any one of Examples 24 to 45, comprising rendering the anatomical structure of a hollow organ on a display.

[0129] Example 47: A computer system comprising at least one processing circuit configured to execute a method for providing real-time visual feedback of the level of contact between a tissue wall of a luminal organ and an ablation catheter. The ablation catheter comprises a plurality of electrodes forming an elongated electrode array disposed along a catheter distal assembly. The method includes rendering a graphical representation of the catheter distal assembly and the plurality of electrodes thereon on a display while the catheter distal assembly is within the luminal organ of the patient. The method includes, for each electrode of the plurality of electrodes, repeatedly assessing tissue proximity of each of the plurality of electrodes while the catheter distal assembly is within the luminal organ of the patient. Further, for each electrode of the plurality of electrodes, the method includes dynamically updating a visual feature indicative of tissue proximity. The visual feature includes a contact lobe, each contact lobe centered on a corresponding electrode and overlaid on the graphical representation of the catheter distal assembly, and a size of the contact lobe increasing with the level of contact between the tissue wall and the corresponding electrode based on tissue proximity.

[0130] Example 48: The computer system of Example 47, wherein assessing tissue proximity includes measuring impedance of at least one electrode.

[0131] Example 49: A computer system described in any one of Examples 47 to 48, wherein when the tissue proximity of adjacent electrodes exceeds a predetermined threshold, the contact lobes corresponding to the adjacent electrodes form a vertex at the intersection region.

[0132] Example 50: A computer system described in any one of Examples 47 to 49, wherein the contact lobes are configured to expand asymmetrically relative to the central axis of the catheter so as to extend primarily transversely toward the tissue wall.

[0133] Example 51: A computer system described in any one of Examples 49-50, including merging overlapping contact lobes corresponding to separate electrodes into a single region.

[0134] Example 52: The computer system of any one of Examples 47 to 51, wherein the contact lobe comprises an elliptical segment.

[0135] Example 53: A computer system as described in Example 52, comprising calculating, for each electrode, a variable transverse radius of the ellipse segment, the variable transverse radius being based on the contact level between the tissue wall and the electrode and extending transversely to the local orientation of the catheter around the electrode.

[0136] Example 54: The computer system of example 53, comprising comparing the transverse radius to an adjacent transverse radius of an adjacent electrode. If the difference between the transverse radius and the adjacent transverse radius is below a predetermined comparison threshold, the local transverse radius at the intersection is smaller than the transverse radius by a predetermined drop threshold.

[0137] Example 55: A computer system described in any one of Examples 53 to 54, wherein the variable transverse radius varies within a radius adjustment range bounded by a minimum radius threshold value and a maximum radius threshold value.

[0138] Example 56: The computer system of Example 55, wherein the minimum radius threshold corresponds to a zero contact level.

[0139] Example 57: A computer system described in any one of Examples 52 to 55, wherein the ellipse segment includes a tangent radius extending in the direction of the local orientation of the catheter.

[0140] Example 58: The computer system of Example 57, wherein the tangent radius is constant and is based on the spacing between electrodes of the electrode array.

[0141] Example 59: A computer system described in any one of Examples 57 to 58, wherein the tangent radius is equal to half the sum of the distances to adjacent electrodes along the catheter.

[0142] Example 60: A computer system described in any one of Examples 57 to 59, wherein the local orientation of the catheter around a given electrode is defined according to a tangent to the above-mentioned catheter distal assembly at the location of the given electrode.

[0143] Example 61: The computer system of any one of Examples 49 to 60, comprising merging overlapping contact lobes corresponding to separate electrodes into a single region.

[0144] Example 62: The computer system of any one of Examples 47-61, comprising coloring the contact lobes using a transparent infill.

[0145] Example 63: The computer system of Example 62, wherein a first color indicates that the contact level is below a minimum threshold and a second color indicates that the contact level is above the minimum threshold.

[0146] Example 64: A computer system described in any one of Examples 62 to 63, wherein the above-mentioned ellipse segments are curved according to the curvature of the catheter.

[0147] Example 65: A computer system described in any one of Examples 47 to 64, comprising calculating, for each contact lobe, multiple local transverse radii at corresponding multiple locations according to tangential distance from the electrode.

[0148] Example 66: The computer system of Example 65, wherein the local radius is calculated for distance increments of 0.5 millimeters.

[0149] Example 67: A computer system described in any one of Examples 47 to 66, wherein the hollow organ is the patient's heart.

[0150] Example 68: A computer system described in any one of Examples 47 to 67, wherein all electrodes included in the plurality of electrodes form a linear array.

[0151] Example 69: A computer system described in any one of Examples 47 to 68, which includes rendering the anatomical structure of a hollow organ on a display.

[0152] Example 70: A non-transitory computer-readable storage medium tangibly embodying a program of instructions that, when executed by a computer, causes the computer to perform the method described in any one of Examples 1 to 23.

[0153] Example 71: A non-transitory computer-readable storage medium that tangibly embodies a program of instructions that, when executed by a computer, causes the computer to execute the GUI described in any one of Examples 24 to 46.

[0154] While the present disclosure has been described in terms of preferred embodiments, those skilled in the art to which this disclosure pertains will appreciate that the conception upon which this disclosure is based may be readily utilized as a basis for the designing of other structures, systems and processes for carrying out the several purposes of the present disclosure.

[0155] It is further to be understood that the phraseology and terminology used herein are for descriptive purposes and should not be regarded as limiting. It is noted that the words "comprising," "including," and "having," as used throughout the appended claims, should be interpreted to mean "including but not limited to." The indefinite articles "a" and "an," as used in the specification and claims, should be understood to mean "at least one," unless clearly indicated to the contrary. The term "and / or," as used in the specification and claims, should be understood to mean "either or both" of the elements so conjoined, i.e., elements that are conjunctively present in some cases and disjunctively present in other cases. The term "each" need not be understood exclusively as referring to each and all, and may, where technically relevant, refer to "at least some."

[0156] All patents and patent applications mentioned in this specification are incorporated by reference in their entirety as if each individual patent or patent application was specifically and individually indicated to be incorporated by reference herein. Citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present disclosure.

[0157] It is important, therefore, that the scope of the present disclosure is not construed as limited by the illustrative examples set forth herein. Other variations are possible within the scope of the present disclosure, as defined in the appended claims. Other combinations and subcombinations of features, functions, elements, and / or properties may be claimed by amending the present claims or by presenting new claims in this or a related application. Such modifications or new claims, whether directed to different or the same combinations, and whether different, broader, narrower, or the same in scope as the original claims, are also deemed to fall within the inventive subject matter of this description.

[0158] [Embodiment] (1) A computer-implemented method for providing real-time visual feedback of the level of contact between a tissue wall of a luminal organ and an ablation catheter comprising a plurality of electrodes forming an elongated electrode array disposed along a catheter distal assembly, the method comprising: While the catheter distal assembly is within the luminal organ of the patient, (a) rendering on a display a graphical representation of the catheter distal assembly and the plurality of electrodes thereon; (b) for each electrode of the plurality of electrodes, i. repeatedly assessing tissue proximity of each of said plurality of electrodes; ii. dynamically updating visual features indicative of said tissue proximity, said visual features comprising contact lobes; each contact lobe is centered on a corresponding electrode and overlaid on the graphical representation of the catheter distal assembly; A computer-implemented method, wherein the size of the contact lobe increases with the level of contact between the tissue wall and the corresponding electrode based on the tissue proximity. (2) A computer-implemented method as described in embodiment 1, wherein assessing tissue proximity includes measuring the impedance of at least one electrode. (3) The computer-implemented method of embodiment 1, wherein if the assessed tissue proximity of adjacent electrodes exceeds a predetermined threshold, the contact lobes corresponding to the adjacent electrodes form a vertex at an intersection region. (4) A computer-implemented method as described in embodiment 1, wherein the contact lobes are configured to expand asymmetrically relative to a central axis of the catheter so as to extend primarily transversely toward the tissue wall. (5) The computer-implemented method of claim 3, further comprising merging overlapping contact lobes corresponding to separate electrodes into a single region.

[0159] (6) The computer-implemented method of claim 1, wherein the contact lobe comprises an elliptical segment. (7) The computer-implemented method of embodiment 6, further comprising: calculating, for each electrode, a variable transverse radius of the ellipse segment, the variable transverse radius being based on the contact level between the tissue wall and the electrode and extending transversely to the local orientation of the catheter around the electrode. (8) A graphical user interface (GUI) for providing real-time visual feedback of the level of contact between a tissue wall of a luminal organ and an ablation catheter having a plurality of electrodes forming an elongated electrode array disposed along a catheter distal assembly, the GUI comprising: While the catheter distal assembly is within the luminal organ of the patient, (a) rendering on a display a graphical representation of the catheter distal assembly and the plurality of electrodes thereon; (b) for each electrode of the plurality of electrodes, i. repeatedly receiving tissue proximity values ​​for each of the plurality of electrodes; ii. the method is computer executable to dynamically update a visual feature indicative of the tissue proximity value in response to a detected change in the tissue proximity value, the visual feature comprising a contact lobe; each contact lobe is centered on a corresponding electrode and overlaid on the graphical representation of the catheter distal assembly; A GUI where the size of the contact lobe increases with the level of contact between the tissue wall and the corresponding electrode based on the tissue proximity value. (9) A GUI as described in embodiment 8, wherein the tissue proximity value corresponds to a measured impedance value of the plurality of electrodes. (10) A GUI as described in embodiment 8, wherein when the tissue proximity value of adjacent electrodes exceeds a predetermined threshold, the contact lobes corresponding to the adjacent electrodes form a vertex at an intersection region.

[0160] (11) A GUI as described in embodiment 8, wherein the contact lobes are configured to expand asymmetrically relative to the central axis of the catheter so as to extend primarily transversely toward the tissue wall. (12) A GUI as described in embodiment 10, configured to merge overlapping contact lobes corresponding to separate electrodes into a single region. (13) The GUI of embodiment 8, wherein the contact lobe comprises an elliptical segment. (14) A GUI as described in embodiment 13, configured to calculate, for each electrode, a variable transverse radius of the ellipse segment, the variable transverse radius being based on the contact level between the tissue wall and the electrode and extending transversely to the local orientation of the catheter around the electrode. (15) A computer system comprising at least one processing circuit configured to execute a method for providing real-time visual feedback of a contact level between a tissue wall of a luminal organ and an ablation catheter comprising a plurality of electrodes forming an elongated electrode array disposed along a catheter distal assembly, the method comprising: While the catheter distal assembly is within the luminal organ of the patient, (a) rendering on a display a graphical representation of the catheter distal assembly and the plurality of electrodes thereon; (b) for each electrode of the plurality of electrodes, i. repeatedly assessing tissue proximity of each of said plurality of electrodes; ii. dynamically updating visual features indicative of said tissue proximity, said visual features comprising contact lobes; each contact lobe is centered on a corresponding electrode and overlaid on the graphical representation of the catheter distal assembly; A computer system where, based on the tissue proximity, the size of the contact lobe increases with the level of contact between the tissue wall and the corresponding electrode.

[0161] (16) The computer system of embodiment 15, wherein assessing tissue proximity includes measuring impedance of at least one electrode. (17) The computer system of embodiment 15, wherein when the tissue proximity of adjacent electrodes exceeds a predetermined threshold, the contact lobes corresponding to the adjacent electrodes form a vertex at an intersection region. (18) The computer system of embodiment 15, wherein the contact lobes are configured to expand asymmetrically relative to a central axis of the catheter so as to extend primarily transversely toward the tissue wall. (19) The computer system of claim 15, wherein the contact lobe comprises an elliptical segment. (20) The computer system of embodiment 19, wherein the method includes calculating, for each electrode, a variable transverse radius of the ellipse segment, the variable transverse radius being based on the contact level between the tissue wall and the electrode and extending transversely to a local orientation of the catheter about the electrode.

Claims

1. 1. A graphical user interface (GUI) for providing real-time visual feedback of a contact level between a tissue wall of a luminal organ and an ablation catheter comprising a plurality of electrodes forming an elongated electrode array disposed along a catheter distal assembly, the GUI comprising: While the catheter distal assembly is within the luminal organ of the patient, (a) rendering on a display a graphical representation of the catheter distal assembly and the plurality of electrodes thereon; (b) for each electrode of the plurality of electrodes: i. repeatedly receiving tissue proximity values ​​for each of the plurality of electrodes; ii. The method is computer executable to dynamically update visual features indicative of tissue proximity in response to detected changes in tissue proximity values, the visual features including a contact lobe; each contact lobe is centered on a corresponding electrode and overlaid on the graphical representation of the catheter distal assembly; A GUI where the size of the contact lobe increases with the level of contact between the tissue wall and the corresponding electrode based on the tissue proximity.

2. The GUI of claim 1 , wherein the tissue proximity value corresponds to a measured impedance value of the plurality of electrodes.

3. The GUI of claim 1 , wherein if the tissue proximity values ​​of adjacent electrodes are above a predetermined threshold, the contact lobes corresponding to the adjacent electrodes form a vertex at an intersection region.

4. The GUI of claim 1 , wherein the contact lobes are configured to expand asymmetrically relative to a central axis of the catheter so as to extend primarily transversely toward the tissue wall.

5. 5. The GUI of claim 1, wherein the contact lobe comprises an elliptical segment, and the GUI is configured to calculate, for each electrode, a variable transverse radius of the elliptical segment, the variable transverse radius being based on the contact level between the tissue wall and the electrode and extending transversely to a local orientation of the catheter about the electrode.

6. 1. A computer system comprising at least one processing circuit configured to execute a method for providing real-time visual feedback of a contact level between a tissue wall of a luminal organ and an ablation catheter comprising a plurality of electrodes forming an elongated electrode array disposed along a catheter distal assembly, the method comprising: While the catheter distal assembly is within the luminal organ of the patient, (a) rendering on a display a graphical representation of the catheter distal assembly and the plurality of electrodes thereon; (b) for each electrode of the plurality of electrodes: i. repeatedly assessing tissue proximity of each of the plurality of electrodes; ii. dynamically updating visual features indicative of said tissue proximity, said visual features comprising contact lobes; each contact lobe is centered on a corresponding electrode and overlaid on the graphical representation of the catheter distal assembly; A computer system where, based on the tissue proximity, the size of the contact lobe increases with the level of contact between the tissue wall and the corresponding electrode.

7. The computer system of claim 6 , wherein assessing tissue proximity comprises measuring impedance of at least one electrode.

8. The computer system of claim 6 , wherein if the tissue proximity of adjacent electrodes is above a predetermined threshold, the contact lobes corresponding to the adjacent electrodes form an apex at an intersection region.

9. The computer system of claim 6 , wherein the contact lobes are configured to expand asymmetrically relative to a central axis of the catheter so as to extend primarily transversely toward the tissue wall.

10. 10. The computer system of claim 6, wherein the contact lobe comprises an elliptical segment, and the method comprises calculating, for each electrode, a variable transverse radius of the elliptical segment, the variable transverse radius being based on the contact level between the tissue wall and the electrode and extending transversely to a local orientation of the catheter about the electrode.

11. 1. A computer-implemented method for providing real-time visual feedback of the level of contact between a tissue wall of a luminal organ and an ablation catheter comprising a plurality of electrodes forming an elongated electrode array disposed along a catheter distal assembly, the method comprising: While the catheter distal assembly is within the luminal organ of the patient, (a) rendering on a display a graphical representation of the catheter distal assembly and the plurality of electrodes thereon; (b) for each electrode of the plurality of electrodes: i. repeatedly assessing tissue proximity of each of the plurality of electrodes; ii. dynamically updating visual features indicative of said tissue proximity, said visual features comprising contact lobes; each contact lobe is centered on a corresponding electrode and overlaid on the graphical representation of the catheter distal assembly; A computer-implemented method, wherein the size of the contact lobe increases with the level of contact between the tissue wall and the corresponding electrode based on the tissue proximity.

12. The computer-implemented method of claim 11 , wherein assessing tissue proximity comprises measuring impedance of at least one electrode.

13. The computer-implemented method of claim 11 , wherein if the tissue proximity of adjacent electrodes is above a predetermined threshold, the contact lobes corresponding to the adjacent electrodes form a vertex at an intersection region.

14. 12. The computer-implemented method of claim 11, wherein the contact lobes are configured to expand asymmetrically relative to a central axis of the catheter so as to extend primarily transversely toward the tissue wall.

15. 15. The computer-implemented method of claim 11, wherein the contact lobe comprises an elliptical segment, and the method comprises calculating, for each electrode, a variable transverse radius of the elliptical segment, the variable transverse radius being based on the contact level between the tissue wall and the electrode and extending transversely to a local orientation of the catheter about the electrode.

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