Computer methods, systems, and GUI for real-time visual feedback of endoluminal catheter engagement

Abstract

The invention relates to a computer method, system and GUI for real-time visual feedback of intraluminal catheter engagement. The subject matter of the present disclosure includes computer systems, methods, and graphical user interfaces that provide graphical feedback indicative of real-time proximity based on changes in electrical impedance sensed through electrodes of a catheter. By 5 the impedance is related to the proximity of the electrode to the tissue wall, so that the system utilizes impedance measurements to visually change the appearance of the graphical representation of the electrode as a function of sensed impedance changes. The graphical feedback enables a physician to adjust the position of the catheter and the applied force in real time and thereby improve the accuracy and effectiveness of endoluminal catheter treatment.

Description

[0001] Technical Field of the Present Disclosure Subject Matter

[0002] The subject matter of the present disclosure relates to intraluminal catheter therapies for diagnosing and treating medical conditions. Background Art

[0003] Intraluminal catheter therapy (ICT) or catheterization has become a key means in the medical field for diagnosing and treating various medical conditions. This minimally invasive procedure involves guiding a slender flexible tube or catheter into a luminal organ. The catheter is equipped with electrodes for, in particular, mapping the inner lumen and identifying the precise locations associated with abnormal medical conditions.

[0004] Cardiac ICT is an important tool for diagnosing and treating heart diseases, particularly cardiac arrhythmias. This involves inserting a catheter equipped with electrodes through a blood vessel into the heart, using the catheter to generate an electrogram of the heart's electrical activity, and identifying the precise locations of abnormal electrical activity. The identified sites can then be treated by ablation, where targeted energy neutralizes the abnormal tissue, thereby restoring normal heart rhythm. This integrated approach has revolutionized cardiac care, providing patients with options that are less invasive and have shorter recovery times. Brief Description of the Drawings

[0005] To understand the subject matter of the present disclosure and to see how it may be implemented in practice, the subject matter is now described by way of non - limiting example only with reference to the accompanying drawings, in which:

[0006] Figure 1 A schematic diagram of an example of a catheter - based electrophysiological mapping and ablation system;

[0007] Figure 2 is Figure 1 A more detailed isometric view of the expandable end - effector on the distal end of the catheter of;

[0008] Figure 3a A block diagram schematically illustrating a processing circuit configured to provide graphical feedback indicative of real - time proximity according to some examples of the subject matter of the present disclosure;

[0009] Figure 3b Schematically illustrates, according to some examples of the subject matter of the present disclosure, as Figure 3a A block diagram of a graphical proximity feedback engine implemented as part of the processing circuit shown;

[0010] Figure 4 A simplified flowchart of an example method for providing graphical feedback regarding the real - time proximity of an electrode on a catheter to a chamber wall according to an example of the subject matter of the present disclosure; and

[0011] Figure 5A graph corresponding to an impedance-proximity distribution, according to some examples of the present disclosure subject matter.

[0012] Overview

[0013] An important aspect of catheterization in a cardiology context involves tissue contact and ablation accuracy. Ensuring sufficient contact between the catheter distal end assembly (e.g., balloon and / or basket) located at the distal end and the heart tissue is crucial for accurate and effective results.

[0014] A physician manipulating the catheter would benefit from knowing how much force is applied to the tissue wall. The force distribution on the distal end assembly can assist the physician in precisely manipulating the end. This information can be used, for example, during mapping of the inner surface of a luminal organ such as the heart. During mapping, multiple points are collected from the surface of the inner chamber wall through the catheter. To obtain an accurate map, it is desirable to avoid applying excessive force to the tissue when manipulating the catheter, as this can cause deformation (e.g., bulging) of the tissue surface and thus result in an inaccurate mapping output. During various other procedures such as pulsed field ablation (PFA), an indication of the force applied to the tissue wall is also helpful. Too little contact can render ablation ineffective, while too much pressure can cause excessive tissue damage. An indication of the proximity between the catheter and the tissue can assist the physician in reaching a threshold level of force to achieve a desired lesion depth.

[0015] The subject matter of the present disclosure includes computer systems, methods, and graphical user interfaces that provide graphical feedback indicating real-time proximity based on changes in electrical impedance sensed by electrodes of a catheter. Since impedance is related to the proximity of the electrodes to the tissue wall, the system utilizes impedance measurements to visually alter the appearance of the graphical representation of the electrodes based on sensed impedance changes. This graphical feedback enables the physician to make real-time adjustments to the position of the catheter and the applied force, and thereby improve the accuracy and effectiveness of ICT. For example, if the impedance indicates insufficient contact, the physician can reposition the catheter to achieve better engagement with the tissue. Conversely, a high impedance reading can signal excessive pressure, prompting the physician to reduce the contact force to prevent bulging and / or potential tissue damage. Detailed Description

[0016] In the listed drawings and description, like reference numerals represent those components common to different embodiments or configurations. The elements in the drawings are not necessarily drawn to scale.

[0017] Unless otherwise specifically stated, it will be apparent from the following discussion that throughout this specification, discussions utilizing terms such as "display," "determine," "update," "generate," etc., include actions and / or processes of a computer that manipulate data 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.

[0018] The terms "computer", "computer system", "computer device", etc. should be interpreted expansively to include any kind of hardware-based electronic device having one or more data processing circuits. Each processing circuit may include, for example, one or more processors operatively connected to (including non-transitory) computer memory loaded with executable instructions for performing operations, as further described below.

[0019] The one or more processors referred to herein may represent, for example, one or more general-purpose processing devices, such as a microprocessor, a central processing unit, etc. More specifically, a given processor may be one of the following: 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.

[0020] Figure 1 , Figure 3a and Figure 3b Diagrams illustrating system architectures according to certain examples of the disclosed subject matter. Figure 1 , Figure 3a , Figure 3b and Figure 2 The elements in may be comprised of any combination of software and hardware and / or firmware that performs the functions as defined and explained herein. Figure 1 , Figure 3a and Figure 3b The elements in the computer 55 may be concentrated in one location or dispersed in more than one location. In some examples, certain operations may be implemented by a remote cloud computing infrastructure, where information is sent from the computer 55 to the cloud, processing is performed at the cloud, and the processing output is transmitted back to the computer 55.

[0021] The term luminal organ refers to any organ having a lumen (ie, an internal space, chamber, or passageway). Luminal organs include, for example, blood vessels, kidneys, bladder, urethra, heart, and colon.

[0022] With the above in mind, please note that Figure 1An example of the ICT system shown. More specifically, Figure 1 A catheter-based electrophysiological mapping (also referred to herein as "cardiac mapping") system 10 is shown. In some cases, system 10 can also be used for ablation. System 10 includes one or more catheters that are inserted by a physician 24 through the patient's vascular system via the skin into a chamber or vascular structure of the heart 12. Generally, a delivery sheath catheter is inserted into the left atrium or right atrium near a desired location in the heart 12. Then, one or more catheters can be inserted into the delivery sheath catheter to reach the desired location in the heart 12. The catheter types can include, for example: catheters dedicated to sensing intracardiac electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An example catheter 14 is illustrated herein. In some examples, the physician 24 places the distal end assembly 28 of the catheter 14 in contact with the heart wall for sensing a target site in the heart 12. For ablation, the physician 24 can similarly place the distal end of the ablation catheter in contact with the target site for ablating tissue.

[0023] Catheter 14 is a non-limiting example of a catheter that includes one and preferably a plurality of electrodes 66 (such as a plurality of splines 62 at the distal end assembly 28) distributed on the distal end assembly. In addition to the electrodes, catheter 14 can further include a position sensor 29 that is embedded in or near the distal tip 28 for tracking the position and orientation of the distal end assembly 28. In some examples, the position sensor 29 is a magnetic-based position sensor that includes three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0024] The electrical activity at various points within the heart is typically sensed and measured by advancing a catheter containing one or more electrical sensors into the heart chamber and collecting data at multiple points. Then, these data are used to calculate an electroanatomical map of the heart chamber or a portion thereof.

[0025] The magnetic-based position sensor 29 can operate in conjunction with a positioning pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field in a predefined workspace. The real-time position of the distal end of the shaft of catheter 14 can be tracked based on the magnetic field generated by the positioning pad 25 and sensed by the magnetic-based position sensor 29. Details of the magnetic-based position sensing technique are described in U.S. Patents Nos. 5,391,199, 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, 6,892,091.

[0026] System 10 may also include one or more electrode patches 38 that are positioned to contact the skin of patient 23 to establish a position reference for impedance-based tracking of the positioning pad 25 and electrodes 26. For impedance-based tracking, current is directed to electrodes 26 and sensed at the electrode skin patches 38 such that the position of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Patent Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182.

[0027] Electrode 66 may also be configured to receive an AC signal when paired with a reference electrode. The impedance in response to the AC signal can be sensed and used to determine the local proximity between electrode 66 and a tissue wall (e.g., a chamber wall). For example, an exemplary method for assessing proximity based on impedance is described in U.S. Patent Application No. 20210177504.

[0028] Recorder 11 records and displays the electrogram 21 captured using the body surface ECG electrodes 18 and the intracardiac electrogram (IEGM) captured using the electrodes 66 of catheter 14. Recorder 11 may include pacing capabilities for pacing the heart rhythm and / or may be electrically connected to an independent pacemaker.

[0029] In some examples, system 10 may include an ablation energy generator 50 that is adapted to conduct ablation energy to one or more of the electrodes at the distal end of a catheter configured for ablation. The energy generated by ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high voltage DC pulses that can be used to effect irreversible electroporation (IRE)), or combinations thereof.

[0030] In some examples, system 10 further includes a patient interface unit (PIU) 30, which is an interface device configured to establish electrical connectivity between the catheter, 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, a plurality of catheters, positioning pad 25, body surface ECG electrodes 18, electrode patches 38, ablation energy generator 50, and recorder 11. According to some examples, PIU 30 additionally includes processing capabilities for performing real-time calculations of the position of the catheter and for performing ECG calculations.

[0031] Workstation 55 includes processing circuitry that includes one or more processors operatively connected to a computer memory of some kind. The processing circuitry may execute appropriate operating software and user interface functions. Workstation 55 may provide a variety of functions, optionally including, for example:

[0032] -Model the endocardial anatomy in three dimensions (3D) and render a 3D graphical representation of the model or anatomical map 20 for display on a display device 27.

[0033] -Display the activation sequence (or other data) compiled from the recorded electrogram 21 on the display device 27 with representative visual markers (e.g., by color coding) or images superimposed or overlaid on the rendered anatomical map 20.

[0034] -Render a real-time 3D graphical representation of the distal end component 28 for display on the display device 27.

[0035] -Display the real-time position and orientation of one or more catheters within the heart chamber.

[0036] -Display on the display device 27 the site of interest, such as where ablation energy has been applied.

[0037] An article of commerce embodying the elements of the system 10 is available under the trade name CARTO TM 3 System, which is available from Biosense Webster, Inc., 31A Technology Drive, Irvine, CA 92618.

[0038] Now refer to Figure 2 which is a more detailed isometric view of the expandable end component on the distal end of the Figure 1 catheter of

[0039] The distal end component 28 is an expandable component formed by a plurality of splines 64. In some examples, each of the splines 64 includes a plurality of electrodes configured to sense IEGM, such as from 2 to 10 electrodes 66.

[0040] Figure 3a is a block diagram schematically illustrating a computer including a processing circuit according to certain examples of the subject matter of the present disclosure, the processing circuit being configured to perform data processing operations related to graphical feedback indicative of real-time proximity. The computer 55 (or what was referred to above as "workstation 55") is operatively connected to Figure 1 the system 10 disclosed in

[0041] The computer 55 includes processing circuitry 330 that includes at least one computer processor operatively connected to a computer memory 303. For example, a central processing unit (CPU 301) may be configured to perform various calculations and data processing required to generate and render 3D graphics of the catheter when the catheter is inserted into the heart. The memory is configured to store relevant software, including, for example, computer instructions dedicated to generating and updating 3D graphics of the heart. The processing circuitry may further include a graphics processing unit (GPU) 305 that is configured to accelerate graphics rendering tasks, including rapidly and simultaneously drawing shapes and applying textures. A data storage device 310 is configured to store various data, such as computer programs, files, textures, and software tools including user interface software. Software and other data stored on the data storage device 310 may be uploaded to the memory 303 during execution. As described above, reference Figure 1 , the computer 55 is operatively connected to a display device (e.g., Figure 1 the display 27 shown in

[0042] ), as well as other user interaction devices 307 such as a computer mouse and keyboard, to be able to view the 3D graphics and other software and hardware tools and interact with the 3D graphics and the other software and hardware tools.

[0043] Figure 3a By way of example, a catheter simulation module 311 that is generally configured to generate a graphical simulation of a distal end of a catheter, a rendering engine 313 that is configured to render various graphics including a graphical representation of the distal end of the catheter, and a real-time proximity feedback engine 320 that is configured to generate and provide real-time proximity feedback are shown, as further described below. An example of a more detailed description of the components of the real-time proximity feedback engine 320 is shown in Figure 3b , and the operations are described with reference to Figure 4 therein.

[0044] Figure 4 FIG. is a flowchart of operations implemented as part of a cardiac mapping procedure according to certain examples of the subject matter disclosed herein. For clarity and by way of non-limiting example, the operations in Figure 1 , Figure 3a and Figure 3b are described with reference to the components shown in Figure 4 .

[0045] As described above, during intravascular catheter therapy (ICT), a catheter carrying multiple electrodes is inserted into a patient's luminal organ (401). Detection of the proximity of the catheter to the tissue wall of the organ is essential for performing various tasks, including mapping the inner surface of the organ and accurately applying medical procedures within the organ, such as ablation performed within a heart chamber.

[0046] The Tissue Proximity Index (TPI) represents the relationship between the impedance measured by the electrodes and their proximity to the tissue wall. Figure 5 A graph depicting the TPI distribution (impedance-proximity distribution) where the x-axis corresponds to the proximity of the catheter to the tissue (reciprocal of distance) and the y-axis corresponds to the impedance value.

[0047] When the electrodes are not in contact with the tissue wall, the change in impedance is caused by the difference in electrical properties between the tissue and other media with which the electrodes are in contact, such as air or blood. In cardiac ICT, typically the catheter is first inserted into a major blood vessel and then navigated into the heart. Initially, the catheter is in contact with blood, which has a relatively low impedance. The catheter is then carefully advanced towards the heart tissue until it contacts the tissue wall. The tissue wall is characterized by a higher impedance compared to blood, which can be detected and used to confirm proper contact between the catheter and the heart tissue.

[0048] As Figure 5 shown, the graph is non-linear and can be divided into three distinct phases, including a non-contact phase, a contact phase, and a contact saturation phase. In the initial non-contact phase, the electrodes are in contact with blood and not with the tissue wall. In this phase, the measured impedance is relatively low. As the electrodes are moved closer to the tissue wall, the measured impedance increases. At a specific point marking the initial contact of the electrodes with the tissue, a sharp increase in the measured impedance is observed. After this sharp rise, the graph levels off and enters the saturation phase. In this phase, the electrodes are in full contact with the tissue, and applying additional pressure to the electrodes does not result in a significant increase (if any) in the impedance measurement.

[0049] Although Figure 5 the general TPI distribution shown is known, each electrode is associated with a different TPI (or impedance-proximity) response curve, depending on the specific impedance value it measures. The difference in values can be caused, for example, by the distance of each electrode from a reference electrode (e.g., fixed on the catheter and used to measure impedance values).

[0050] Thus, to facilitate proximity detection based on electrode impedance measurement results, a calibration procedure is implemented when the catheter is initially inserted into the organ being tested. The operations listed as part of the calibration procedure are performed for each electrode on the catheter. As part of the calibration procedure, a corresponding TPI response curve is determined for each electrode located at the distal end assembly (block diagram 403; e.g., by the TPI response-curve calculator 321 in the real-time proximity feedback engine 310). This response curve defines the relationship between the impedance measurement results and the proximity observed through a particular electrode.

[0051] Considering one electrode on the catheter, after the catheter is inserted into the heart, within a short period of time (e.g., two seconds or less), a set of impedance measurements obtained by the electrode while the physician manipulates the catheter is recorded and processed. The minimum impedance measurement value and the maximum impedance measurement value are extracted from the set of impedance measurements. The minimum impedance value is set to the value of X = 0 in the graph, and the maximum impedance value is set to the maximum impedance value before the plateau. The y-axis representing the measured impedance values is scaled so that its maximum and minimum values are aligned with the maximum and minimum values.

[0052] It is worth noting that when calibrating multiple electrodes on the catheter, redundant electrodes can be used to accelerate the process of calculating the response curve for each electrode. Knowing the distance of each electrode from a fixed reference point (e.g., a reference electrode), any distance-related effects can be systematically adjusted. This facilitates applying a consistent correction to all electrodes, adjusted according to their respective distances, which effectively simplifies the calibration process. The adjustment of one electrode notifies the adjustments required for other electrodes, thus making the process more efficient and ensuring consistency across the catheter.

[0053] According to the subject matter of the present disclosure, once the scaled TPI response curve of a given electrode is obtained, two threshold points for that electrode are determined (block diagram 405 and block diagram 407; e.g., by the TPI metric calculator 323 in the real-time proximity feedback engine 310). The first threshold indicates the impedance value measured at the baseline or at the initial contact with the tissue (marked by the left arrow in Figure 5 ), and the second threshold indicates the impedance value measured before the contact saturation plateau (marked by the right arrow in Figure 5 ).

[0054] According to one example, the first threshold can be determined based on a certain predefined low percentile of the minimum value, and the second threshold can be determined based on a certain predefined high percentile of the maximum value. For example, the first threshold can be set according to the 50th percentile, which defines impedance measurement results above this percentile to indicate contact. The second threshold can be set according to the 90th percentile, which defines impedance measurement results above this percentile to indicate contact saturation.

[0055] After determining the first threshold and the second threshold, a corresponding graphical feature index is determined for each electrode (block diagram 409; e.g., by the color - coding index generator 325 in the real - time proximity feedback engine 310). The graphical feature index is used to convert impedance values into corresponding graphical elements that visually represent different values and provide real - time graphical feedback to the physician regarding the proximity of the electrode to the tissue wall of the luminal organ. This feedback provides information to the physician regarding the quality or degree of engagement (contact) between the distal end of the catheter and the tissue wall.

[0056] According to one example, the graphical feature is color, and the graphical feature index is implemented as a color - coding index that is used to convert impedance values into corresponding colors, which are used to color the corresponding graphical elements representing the electrodes in the 3D graphical visualization of the catheter. It is noted that the term "color - coding" is used to include any type of color model, including but not limited to grayscale models, RGB (red, green, blue) models, HSV (hue, saturation, value) models, etc. Other possible types of graphical features include using different shapes, where different shapes are used to indicate different impedance values, and varying flash frequencies, where different flash frequencies are used to indicate different impedance values. It should be noted that although the following description is made with respect to the color - coding index, this is only by way of example, and other types of visual features are also contemplated within the scope of the subject matter of the present disclosure.

[0057] The color - coding index associates a first color for impedance values below the first threshold, a second color for impedance values above the second threshold, and multiple additional colors for multiple corresponding impedance values (or ranges of values) between the first threshold and the second threshold.

[0058] Since each electrode may have a different TPI response curve, the corresponding color - coding index can also be different, i.e., different impedance values are associated with different colors. Thus, in some examples, for each electrode, a color - coding scale is applied to the range of values between the first threshold and the second threshold.

[0059] For example, assuming the use of grayscale colors, impedance values below a first threshold are represented by black, impedance values above a second threshold are represented by white, and the range of impedance values between the first and second thresholds can be represented by a plurality of other gray shades in a color-coded scale that is uniformly distributed within that range. Consider a non-limiting example where the range of impedance values is divided by a color-coded scale of three uniformly distributed colors, the impedance values within the range can be divided into three, and are associated with corresponding grayscale values 63, 127, and 191, where 0 represents the first threshold and 255 represents the second threshold. If the range of impedance values is divided by a color-coded scale of five uniformly distributed colors, the impedance values within the range can be divided into five, and are associated with corresponding grayscale values 42, 85, 127, 170, and 212.

[0060] Generate a graphical visualization of a catheter having a plurality of electrodes placed thereon, which graphically represents the catheter (block diagram 411). For example, this can occur before or during a calibration procedure.

[0061] In some examples, with the help of a catheter simulation module 311 and a rendering engine 313 operating in association with the CPU 301 and the GPU 305, a three-dimensional (3D) representation of the catheter is generated that is graphically visualized. The catheter simulation module 311 is configured to generate a graph that replicates the geometry, volume, surface topology, features, texture, etc. of the catheter, and the graph depicts the distal end assembly of the catheter (e.g., the catheter basket) and graphical elements representing the electrodes and optionally other components in a manner that clearly shows their positions and dimensions. The rendering engine 313 is configured to render the graph for display on the display device 27. In some examples, a graphical representation of the tissue wall surrounding the catheter is also provided.

[0062] The electrode color update module 327 in the real-time proximity feedback module 310 is configured to continuously receive impedance measurement values from each electrode, and provide a corresponding color suitable for coloring the electrode based on the impedance values measured in real time. The color of each electrode can be provided to the GPU 305 and used by it during the rendering of the 3D graph. During the initial generation of the 3D graph, default values can be assigned to all electrodes, for example, coloring all electrodes black.

[0063] After the calibration phase, the execution phase (block diagram 430) is initiated. During this phase, when the catheter is being manipulated within a luminal organ (e.g., the heart), each electrode continuously measures impedance values (block diagram 413). In response to changes in the impedance values measured by the electrodes, a color-coded index is applied to select a matching color based on the updated impedance values (block diagram 415).

[0064] Whenever an impedance measurement update is received, the graphical element (box 417) representing the corresponding electrode for which the value was measured is re-rendered using an updated color selected based on the most recently measured impedance value.

[0065] In some examples, the electrode color update module 327 receives an impedance measurement stream, determines a matching color using, for example, a color coding index stored in the computer memory 303, and provides the color to the rendering engine 313, which uses the matching color to re-render the corresponding graphical element. The GPU may be configured to execute a shader program that is configured to color different graphical elements based on data received from the electrode color update module 327. The updated 3D visual representation of the catheter is displayed on the display device 27.

[0066] When the catheter is being manipulated within a luminal organ, the operations associated with block diagram 430 are continuously performed. This ensures that the 3D graphics are dynamically updated to reflect the changing proximity of the electrodes to the tissue wall. Thus, this provides continuous, real-time color feedback to the medical practitioner that indicates the quality of the catheter's engagement with the tissue wall.

[0067] During a medical procedure, such as mapping the inner surface of a luminal organ or ablation while a physician manipulates a catheter within the organ, the physician can view the 3D catheter graphic displayed on the screen and use the real-time generated color feedback of the catheter graphic to bring the catheter into contact with the tissue and adjust the degree of contact, and manage the force applied to the tissue to a desired level, thereby enhancing the accuracy and efficiency of the medical procedure.

[0068] According to a first aspect of the subject matter of the present disclosure, there is provided a computer-implemented method that uses a catheter to provide real-time visual feedback of intraluminal catheter engagement, the catheter including one or more electrodes disposed on a distal end assembly of the catheter, the method including:

[0069] When the catheter is within a luminal organ of a patient:

[0070] Render a graphical representation of the distal end assembly of the catheter and the one or more electrodes thereon on a display;

[0071] For each of the one or more electrodes:

[0072] Identify an impedance range for each of the one or more electrodes that is between a first threshold corresponding to contact with baseline tissue and a second threshold corresponding to contact saturation;

[0073] Define a graphical feature index that associates impedance values within the defined range with corresponding visual features of the graphical representation of the one or more electrodes;

[0074] Repeatedly measure the impedance of each of the one or more electrodes; and

[0075] Dynamically update the respective visual features of the graphical representation of each of the one or more electrodes based on the measured impedance and the graphical feature index, thereby providing dynamic visual feedback indicative of the quality of the engagement of the intravascular catheter with the tissue wall.

[0076] In addition to the above features, the method according to this aspect of the present disclosure may optionally include one or more of the following features (i) to (vii) in any desired and technically possible combination or arrangement:

[0077] i. wherein the luminal organ is the patient's heart.

[0078] ii. wherein the distal end assembly is a basket including a plurality of splines, and the electrodes are distributed on the splines.

[0079] iii. The method further includes:

[0080] Obtain a plurality of impedance values through the electrodes;

[0081] Identify the maximum impedance value and the minimum impedance value;

[0082] Scale the impedance-proximity response distribution according to the maximum impedance value and the minimum impedance value to obtain a corresponding impedance-proximity response curve;

[0083] Determine the first threshold and the second threshold according to the corresponding impedance-proximity response curve; and

[0084] Define a corresponding graphical feature index according to the first threshold and the second threshold.

[0085] iv. wherein the corresponding graphical feature index includes: a first visual feature that represents an impedance value below a first threshold corresponding to contact with baseline tissue; a second visual feature that represents an impedance value above a second threshold corresponding to contact saturation; and a plurality of other visual features that respectively represent a plurality of corresponding impedance values between the first threshold and the second threshold.

[0086] v. wherein the visual feature is color.

[0087] vi. wherein the visual feature is a shade in grayscale.

[0088] vii. wherein the visual feature is a flash rate.

[0089] According to a second aspect of the present disclosure, there is provided a graphical user interface (GUI) that uses a catheter to provide real-time visual feedback of intraluminal catheter engagement, the catheter including one or more electrodes disposed on a distal end assembly of the catheter; the GUI is executed by a computer to:

[0090] Render a graphical representation of the distal end assembly of the catheter on a display, the graphical representation including one or more graphical elements, each graphical element graphically representing a corresponding one of the one or more electrodes; wherein each graphical element is assigned a visual characteristic selected according to a measured impedance value;

[0091] For each of the one or more electrodes:

[0092] Identify an impedance range of each of the one or more electrodes that is between a first threshold corresponding to contact with baseline tissue and a second threshold corresponding to contact saturation;

[0093] Define a graphical feature index that associates impedance values within the defined range with corresponding visual characteristics of the graphical representation of the one or more electrodes;

[0094] Repeatedly receive impedance measurement values measured through the one or more electrodes, and in response to a detected change in the impedance value measured through the electrodes, update in real time the corresponding visual characteristics of the graphical representation of the electrodes based on the measured impedance and the graphical feature index, thereby providing dynamic visual feedback indicating the quality of intraluminal catheter engagement with the tissue wall.

[0095] The subject matter of the present disclosure also contemplates a computer system that includes at least one processing circuit configured to use a catheter to provide real-time visual feedback of intraluminal catheter engagement, the catheter including one or more electrodes disposed on a distal end assembly of the catheter as disclosed in accordance with the first aspect above, wherein the system is operatively connected to a catheter-based electrophysiological mapping system.

[0096] The subject matter of the present disclosure also contemplates a computer system that includes at least one processing circuit configured to perform a method for enhancing intraluminal catheter therapy (ICT) as disclosed in accordance with the first aspect above, wherein the system is operatively connected to a catheter-based electrophysiological mapping system.

[0097] The subject matter of the present disclosure also contemplates a non-transitory computer-readable storage medium tangibly embodying a program of instructions that, when executed by a computer, cause the computer to perform a method for providing real-time visual feedback of intraluminal catheter engagement using a catheter that includes one or more electrodes disposed on a distal end assembly of the catheter as disclosed in accordance with the first aspect above.

[0098] The subject matter of the present disclosure also contemplates a computer program product including instructions that, when executed by a computer, cause the computer to perform a method for enhancing intraluminal catheter therapy (ICT) as disclosed according to the first aspect above.

[0099] The GUI, system, computer program product, and non-transitory program storage device can optionally include one or more of the features (i) to (vii) listed above in any technically possible combination or arrangement, with necessary modifications.

[0100] It will also be understood that a system according to the subject matter of the present disclosure can be a suitably programmed computer. Similarly, the subject matter of the present disclosure contemplates a computer program readable by a computer for performing the methods of the subject matter of the present disclosure. The subject matter of the present disclosure also contemplates a machine-readable non-transitory memory that tangibly embodies an instruction program executable by a machine for performing the methods of the subject matter of the present disclosure.

[0101] It should be understood that the subject matter of the present disclosure is not limited to its application to the details set forth in the specification contained herein or illustrated in the drawings. The subject matter of the present disclosure can have other embodiments and can be practiced and implemented in various ways. In addition, it should be understood that the language and terminology used herein are for the purpose of description and should not be regarded as limiting. Thus, those skilled in the art will appreciate that the concepts upon which the present disclosure is based can readily be utilized as a basis for designing other structures, methods, and systems for carrying out several purposes of the subject matter of the present disclosure.

Claims

1. A computer-implemented method for providing intraluminal Real-time visual feedback of catheter engagement, the catheter including a catheter placed on a distal tip assembly One or more electrodes, the method comprising: While the catheter is in the patient's luminal organ: rendering on a display a graphical representation of the catheter distal tip assembly and the one or more electrodes thereon; For each of the one or more electrodes: identifying an impedance range for each of the one or more electrodes between a first threshold corresponding to baseline tissue contact and a second threshold corresponding to contact saturation; defining a graphical feature index that associates impedance values ​​within a defined range with corresponding visual features of the graphical representation of the one or more electrodes; repeatedly measuring the impedance of each of the one or more electrodes; as well as A respective visual feature of the graphical representation of each of the one or more electrodes is dynamically updated based on the measured impedance and the graphical feature index, thereby providing dynamic visual feedback indicative of quality of engagement of the intraluminal catheter with the tissue wall.

2. The computer-implemented method of claim 1 , wherein: The luminal organs are affected The heart of the one who is in power.

3. The computer-implemented method of claim 1 , wherein: The distal tip assembly is a basket comprising a plurality of splines, and the electrodes are distributed on the splines.

4. The computer-implemented method of claim 1 , further comprising: This includes determining the corresponding impedance-proximity response curve for each electrode, including: obtaining a plurality of impedance values ​​through the electrodes; Identify the maximum impedance value and the minimum impedance value; scaling an impedance-proximity response distribution according to the maximum impedance value and the minimum impedance value to obtain a corresponding impedance-proximity response curve; determining the first threshold and the second threshold according to the corresponding impedance-proximity response curve; and The corresponding graphic feature index is defined according to the first threshold and the second threshold.

5. The method according to claim 1, wherein: The corresponding graphic feature index includes: a first visual feature, wherein the first visual feature represents an impedance value below a first threshold corresponding to baseline tissue contact; a second visual feature, wherein the second visual feature represents an impedance value above a second threshold corresponding to contact saturation; and multiple other visual features, wherein the multiple other visual features respectively represent multiple corresponding impedance values ​​between the first threshold and the second threshold.

6. The computer-implemented method of claim 1 , wherein: The visual characteristic is color.

7. The computer-implemented method of claim 1 , wherein: The visual features are shades of gray.

8. The computer-implemented method of claim 5, wherein: The visual characteristic is flash rate.

9. The computer-implemented method of claim 1, comprising rendering a graphical representation of the luminal organ on the display.

10. A graphical user interface (GUI) for providing real-time visual feedback of intraluminal catheter engagement using a catheter, the catheter comprising one or more electrodes disposed on a distal tip assembly of the catheter, the GUI being executable by a computer to: rendering a graphical representation of the catheter distal tip assembly on a display, the graphical representation comprising one or more graphical elements, each graphically representing a corresponding electrode of the one or more electrodes; wherein, Each graphical element is assigned a visual feature selected according to the measured impedance value; For each of the one or more electrodes: identifying an impedance range for each of the one or more electrodes between a first threshold corresponding to baseline tissue contact and a second threshold corresponding to contact saturation; defining a graphical feature index that associates impedance values ​​within a defined range with corresponding visual features of the graphical representation of the one or more electrodes; Impedance measurements measured by the one or more electrodes are repeatedly received, and in response to detected changes in the impedance values ​​measured by the electrodes, corresponding visual features of the graphical representation of the electrodes are updated in real time based on the measured impedance and the graphical feature index, thereby providing dynamic visual feedback indicating the quality of engagement of the intraluminal catheter with the tissue wall.

11. The GUI according to claim 10, wherein: The visual feature is any one of the following: color; shades of gray; shape; and flash rate.

12. A computer system comprising at least one processing circuit, the computer system being configured to perform a method of providing real-time visual feedback of intraluminal catheter engagement using a catheter, the catheter comprising one or more electrodes disposed on a distal end assembly of the catheter, the method comprising: While the catheter is in the patient's luminal organ: rendering on a display a graphical representation of the catheter distal tip assembly and the one or more electrodes thereon; For each of the one or more electrodes: identifying an impedance range for each of the one or more electrodes between a first threshold corresponding to baseline tissue contact and a second threshold corresponding to contact saturation; defining a graphical feature index that associates impedance values ​​within a defined range with corresponding visual features of the graphical representation of the one or more electrodes; repeatedly measuring the impedance of each of the one or more electrodes; as well as A respective visual feature of the graphical representation of each of the one or more electrodes is dynamically updated based on the measured impedance and the graphical feature index, thereby providing dynamic visual feedback indicative of quality of engagement of the intraluminal catheter with the tissue wall.

13. The system of claim 12, the system being operably connectable to a catheter-based electrophysiological mapping system comprising the catheter, and wherein: The luminal organ is the patient's heart.

14. The system of claim 13, further comprising the catheter, wherein: The distal tip assembly is a basket comprising a plurality of splines, and the electrodes are distributed on the splines.

15. The system of claim 12, wherein: The visual feature is any of: color; shading in grayscale; shape; and flash rate.

16. A non-transitory computer readable storage medium tangibly embodying a program of instructions that, when executed by a computer, cause the computer to perform a method of providing real-time visual feedback of intraluminal catheter engagement using a catheter, the catheter comprising one or more electrodes disposed on a distal tip assembly of the catheter, the method comprising: While the catheter is in the patient's luminal organ: rendering on a display a graphical representation of the catheter distal tip assembly and the one or more electrodes thereon; For each of the one or more electrodes: identifying an impedance range for each of the one or more electrodes between a first threshold corresponding to baseline tissue contact and a second threshold corresponding to contact saturation; defining a graphical feature index that associates impedance values ​​within a defined range with corresponding visual features of the graphical representation of the one or more electrodes; repeatedly measuring the impedance of each of the one or more electrodes; as well as A respective visual feature of the graphical representation of each of the one or more electrodes is dynamically updated based on the measured impedance and the graphical feature index, thereby providing dynamic visual feedback indicative of quality of engagement of the intraluminal catheter with the tissue wall.

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