Computer method, system, and GUI for real-time visual feedback of intraluminal catheter engagement

Abstract

To provide real-time visual feedback of intraluminal catheter engagement.SOLUTION: A presently disclosed subject matter includes a computer system, method, and graphical user interface that provide graphical feedback indicating real-time proximity on the basis of changes in electrical impedance sensed by electrodes of a catheter. As the impedance is related to proximity of the electrodes to the tissue walls, the system utilizes impedance measurements to visually alter appearance of a graphical representation of the electrodes according to changes in the sensed impedance. The graphical feedback enables a physician to make real-time adjustments to the catheter's positioning and applied force, and thereby enhance the precision and effectiveness of intraluminal catheter therapy.SELECTED DRAWING: Figure 1

Description

Technical Field

[0001] The subject matter of the present disclosure relates to intraluminal catheter therapy for the diagnosis and treatment of medical disorders.

Background Art

[0002] Intraluminal catheter therapy (ICT) or catheterization is an extremely important means in the medical field for both the diagnosis and treatment of various medical disorders. This minimally invasive procedure involves introducing an elongated flexible tube or catheter into a luminal organ. Catheters equipped with electrodes are used, inter alia, to map the lumen and identify the exact location associated with an abnormal medical condition.

[0003] Cardiac ICT is an important tool for both the diagnosis and treatment of cardiac disorders, particularly arrhythmias. This involves inserting a catheter equipped with electrodes into the heart through a blood vessel, using the catheter to generate a map of the electrical activity of the heart, and identifying the exact location of abnormal electrical activity. The identified site can then be treated through ablation, and the target energy neutralizes the abnormal tissue and restores a normal heart rhythm. This integrated approach has revolutionized cardiac treatment and provided patients with a less invasive option with a shorter recovery time.

Brief Description of the Drawings

[0004] To understand the subject matter of the present disclosure and to see how the subject matter can actually be implemented, the subject matter is described here by way of non-limiting examples only with reference to the accompanying drawings.

Figure 1

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Figure 3b

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Figure 5

[0005] Overview An important aspect of catheterization in the context of cardiology is related to tissue contact and ablation accuracy. Ensuring proper contact between a catheter distal end assembly (e.g., a balloon and / or a basket) located at the distal end and the heart tissue is important for obtaining accurate and effective results.

[0006] A physician operating a catheter would benefit from knowing how much force is being applied to the tissue wall. The force distribution on the distal end assembly can be utilized by the physician to accurately maneuver the tip. This information can be used, for example, during the mapping of the inner surface of a luminal organ such as the heart. During mapping, multiple points are collected by the catheter from the surface of the inner lumen wall. To obtain an accurate mapping, it is desirable to avoid applying excessive force to the tissue when operating the catheter as this can cause deformation of the tissue surface, such as tenting, which can result in an inaccurate mapping output. An indicator 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 render the ablation ineffective, while too much pressure can cause excessive tissue damage. An indicator of the proximity between the catheter and the tissue can be utilized by the physician to reach a threshold level of force to achieve the desired depth of damage.

[0007] The subject matter of the present disclosure includes a computer system, method, and graphical user interface that provide graphical feedback indicative of real-time proximity based on changes in electrical impedance sensed by an electrode of a catheter. Since impedance is related to the proximity of the electrode to the tissue wall, the system utilizes impedance measurements to visually change the appearance of the graphical representation of the electrode according to the sensed changes in impedance. The graphical feedback enables the physician to make real-time adjustments to the positioning of the catheter and the applied force, thereby improving the accuracy and effectiveness of ICT. For example, if the impedance suggests inappropriate contact, the physician can reposition the catheter to achieve a better engagement with the tissue. Conversely, a high impedance reading can inform of excessive pressure and prompt the physician to reduce the contact force to prevent tenting and / or potential tissue damage.

[0008] Detailed Description In the accompanying drawings and the description thereof, the same reference numerals indicate components common to different embodiments or configurations. The elements of the drawings are not necessarily drawn to scale.

[0009] Unless otherwise specified, as will be apparent from the following description, throughout this specification, descriptions using terms such as "displaying", "determining", "updating", "generating", etc. mean operations and / or processes of a computer that manipulate and / or transform data into other data, where the data is represented, for example, as a physical quantity such as an electronic quantity, and / or the data is understood to represent a physical object.

[0010] Terms such as "computer", "computer system", "computer device", etc. should be construed expansively to include any type of hardware-based electronic device having one or more data processing circuits. Each processing circuit can comprise one or more processors operably connected to a computer memory (including non-transitory) into which executable instructions for performing operations are loaded, as further described below.

[0011] One or more processors referred to in this specification can represent one or more general-purpose processing devices such as, for example, a microprocessor, a central processing unit, etc. More specifically, a given processor can 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 another instruction set, or a processor implementing a combination of instruction sets. One or more processors can also be one or more dedicated 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] FIG. 1, FIG. 3a, and FIG. 3b illustrate schematic diagrams of system architectures according to certain embodiments of the subject matter of this disclosure. The elements of FIG. 1, FIG. 3a, FIG. 3b, and FIG. 2 can be composed of any combination of software, hardware, and / or firmware that perform the functions defined and described herein. The elements of FIG. 1, FIG. 3a, and FIG. 3b can be centralized in one location or distributed over two or more locations. In some embodiments, a particular operation can be implemented by a remote cloud computing infrastructure, where information is transmitted from computer 55 to the cloud, processing is executed at the cloud, and the processing output is returned to computer 55.

[0013] The term "lumen-containing organ" refers to any organ having a lumen, i.e., an internal space, cavity, or channel. Examples of lumen-containing organs include blood vessels, kidneys, bladders, urethras, hearts, and colons.

[0014] With the above in mind, turn attention to FIG. 1, which shows an example of an ICT system. More specifically, FIG. 1 shows a catheter-based electrophysiology mapping (also referred to herein as "cardiac mapping") system 10. In some cases, system 10 can also be used for ablation. System 10 includes one or more catheters that are percutaneously inserted by a physician 24 into a cardiac chamber or vascular structure of the heart 12 through the patient's vasculature. Typically, a delivery sheath catheter is inserted into the left atrium or right atrium near the desired location of the heart 12. Thereafter, one or more catheters can be inserted into the delivery sheath catheter to reach the desired location within 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 exemplary catheter 14 is illustrated herein. In some embodiments, the physician 24 can place the distal end assembly 28 of the catheter 14 in contact with the heart wall to sense the target site of 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 ablation of the tissue.

[0015] Catheter 14 is a non-limiting example of a catheter that includes one, and preferably a plurality of, electrodes 66, with the plurality of electrodes 66 being distributed across a distal end assembly, such as distal end assembly 28, that includes a plurality of splines 62. In addition to the electrodes, catheter 14 may further include a position sensor 29 embedded within or near distal end assembly 28 to track the position and orientation of distal end assembly 28. In some embodiments, position sensor 29 is a magnetic-based position sensor that includes three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0016] Electrical activity at points within the heart is typically sensed and measured by inserting a catheter incorporating one or more electrical sensors into a cardiac chamber of the heart and acquiring data at multiple points. These data are then utilized to compute an electroanatomical map of the cardiac chamber or a portion thereof.

[0017] The magnetic-based position sensor 29 may operate in conjunction with a position 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 end of the shaft of catheter 14 can be tracked based on the magnetic field generated by position pad 25 and sensed by the magnetic-based position sensor 29. Details of magnetic-based position sensing techniques are described in U.S. Patent 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, and 6,892,091.

[0018] System 10 may further include one or more electrode patches 38 positioned to contact the skin on patient 23 to establish a position reference for the position pads 25 and impedance-based tracking of the electrodes 26. In the case of impedance-based tracking, current is directed to the electrodes 26 and sensed at the electrode-skin patches 38 so that the location of each electrode can be triangulated via the electrode patches 38. Details of impedance-based position tracking techniques are described in U.S. Pat. Nos. 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182.

[0019] Electrode 66 may also be configured to receive an AC signal while paired with a reference electrode. The impedance in response to the AC signal may be sensed and used to determine the local proximity between the electrode 66 and a tissue wall (e.g., a chamber wall). Exemplary methods for evaluating proximity based on impedance are described, for example, in U.S. Patent Application Publication No. 20210177504.

[0020] Recorder 11 may record and display the potential map 21 captured by the body surface ECG electrodes 18 and the intracardiac electrogram (IEGM) captured by the electrodes 66 of the catheter 14. Recorder 11 may include pacing capabilities for pacing the rhythm of the heart and / or may be electrically connected to an independent pacer.

[0021] In some embodiments, system 10 includes an ablation energy generator 50, which is adapted to transmit ablation energy to one or more electrodes at the distal tip of a catheter configured to ablate. The energy generated by ablation energy generator 50 may include radiofrequency (RF) energy or pulsed field ablation (PFA) energy, or a combination thereof, including unipolar or bipolar high voltage DC pulses such as can be used to effect irreversible electroporation (IRE), but is not limited thereto.

[0022] In some embodiments, system 10 further includes a patient interface unit (PIU) 30, which is an interface device configured to establish electrical communication between a catheter, other electrophysiological devices, a power source, and a workstation 55 for controlling the operation of system 10. The electrophysiological devices of system 10 may include, for example, a plurality of catheters, position pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. According to some embodiments, PIU 30 additionally includes the ability to implement real-time calculation of the location of the catheter and processing capabilities for performing ECG calculations.

[0023] Workstation 55 includes a processing circuit comprising one or more processors operably connected to a certain type of computer memory. Appropriate operating software and user interface capabilities can be executed by the processing circuit. Workstation 55 may optionally provide a plurality of functions, including, for example, the following. - To render a 3D graphical representation of a model or anatomical map 20 for modeling the endocardial anatomical structure in three dimensions (3D) and displaying it on a display device 27. - To display, on a display device 27, an activation sequence (or other data) compiled from a recorded electrogram 21 as a representative visual symbol (e.g., by color coding) or image superimposed or overlaid on the rendered anatomical map 20. - To render a real-time 3D graphic representation of the distal end assembly 28 for display on a display device 27. - To display the real-time location and orientation of one or more catheters within the heart chamber. - To display on a display device 27 a target site such as the location where ablation energy has been applied.

[0024] One commercially available product embodying the elements of the system 10 is available as the CARTO (trademark) 3 system, commercially available from Biosense Webster, Inc., 31A Technology Drive, Irvine, CA 92618.

[0025] Referring now to FIG. 2, FIG. 2 is a more detailed isometric view of the expandable end assembly on the distal tip of the catheter of FIG. 1.

[0026] The distal end assembly 28 is an expandable assembly formed by a plurality of splines 64. In some embodiments, each of the splines 64 includes a plurality of electrodes, e.g., 2 to 10 electrodes 66, configured to sense IEGM.

[0027] FIG. 3a is a block diagram generally illustrating a computer comprising a processing circuit configured to perform data processing operations related to graphical feedback indicative of real-time proximity, according to certain embodiments of the subject matter of the present disclosure. Computer 55 (also referred to herein as "workstation 55") is operably connected to system 10 disclosed in FIG. 1. In particular, in some embodiments, certain operations described with reference to computer 55 are performed by PIU 30.

[0028] Computer 55 comprises a processing circuit 330 comprising at least one computer processor operably connected to a computer memory 303. For example, a central processing unit (CPU 301) can be configured to perform various calculations and data processing necessary to generate and render 3D graphics while a catheter is inserted into the heart. The memory is configured to store related software, including, for example, computer instructions dedicated to the generation and updating of 3D graphics of the heart. The processing circuit can further comprise a graphics processing unit (GPU) 305 configured to speed up graphics rendering tasks including drawing shapes and quickly and simultaneously applying textures. A data storage device 310 is configured to store various data such as software tools including computer programs, files, textures, and user interface software. The software and other data stored in data storage device 310 can be uploaded to memory 303 during execution. As described above with reference to FIG. 1, computer 55 is operably connected to a display device (e.g., display 27 shown in FIG. 1), as well as other user interaction devices 307 such as a computer mouse and keyboard, to enable viewing and interacting with 3D graphics as well as other software and hardware tools.

[0029] As will be described in further detail with reference to the following figures, the processing circuit 330 can be configured to execute several functional modules in accordance with computer-readable instructions implemented on a non-transitory computer-readable storage medium. By way of example, such functional modules are illustrated within the data storage device 310.

[0030] FIG. 3a shows, by way of example, a catheter simulation module 311 configured generally to generate a graphical simulation of a distal end of a catheter, a rendering engine 313 configured to render various graphics including a graphical representation of the distal end of the catheter, and a real-time proximity feedback engine 320 configured to generate and provide real-time proximity feedback, which will be described further below. An example of a more detailed description of the components of the real-time proximity feedback engine 320 is shown in FIG. 3b and is described with reference to the operation of FIG. 4.

[0031] FIG. 4 is a flowchart of operations implemented as part of a cardiac mapping procedure according to certain embodiments of the subject matter of the present disclosure. For clarity and by way of non-limiting example, the description of the operations of FIG. 4 is made with reference to the components shown in FIGS. 1, 3a, and 3b.

[0032] As described above, during intravascular catheter therapy (ICT), a catheter carrying a plurality of 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 the completion of various tasks, including mapping of the inner surface of the organ and accurate application of medical procedures within the organ such as ablation performed within the heart chamber.

[0033] The tissue proximity index (TPI) represents the relationship between the impedance measured by an electrode and its proximity to the tissue wall. Figure 5 is a graph depicting the TPI profile (impedance-proximity profile), where the x-axis corresponds to the proximity of the catheter from the tissue (reciprocal of the distance), and the y-axis corresponds to the impedance value.

[0034] The change in impedance results from the difference between the electrical properties of the tissue and other media such as air or blood that the electrode contacts when not in contact with the tissue wall. In cardiac ICT, the catheter is typically first inserted into a major blood vessel and then guided into the heart. First, the catheter is in contact with blood, which has a lower impedance. Then, the catheter is 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.

[0035] As shown in Figure 5, the graph is non-linear and can be divided into three different stages, including a non-contact stage, a contact stage, and a contact saturation stage. In the initial non-contact stage, the electrode is in contact with blood and does not reach the tissue wall. In this stage, the measured impedance is relatively low. As the electrode approaches the tissue wall, the measured impedance increases. At a certain point indicating the initial contact between the electrode and the tissue, a sharp increase in the measured impedance is observed. After this steep rise, the graph levels off into a plateau and enters the saturation stage. During this stage, the electrode is in complete contact with the tissue, and the application of additional pressure to the electrode does not result in a significant increase, if any, in the impedance measurement.

[0036] Although a general TPI profile as shown in FIG. 5 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 arise, for example, from the distance of each electrode from a reference electrode that is fixed to the catheter and used to measure the impedance value.

[0037] Therefore, a calibration procedure is implemented when the catheter is initially inserted into the organ under test to facilitate proximity detection based on the impedance measurement of the electrodes. The operations listed as part of the calibration procedure are performed for each electrode on the catheter. As part of the calibration procedure, for each electrode located on the distal end assembly, its respective TPI response curve is determined (block 403, e.g., by the TPI response curve computer 321 within the real-time proximity feedback engine 310). The response curve defines the relationship between the impedance measurement and the proximity observed by a specific electrode.

[0038] Considering one electrode on the catheter, after the catheter is inserted into the heart, a set of impedance measurement values obtained by the electrode while the catheter is being manipulated by a physician for a short period (e.g., 2 seconds or less) is recorded and processed. From the set of impedance measurement values, the minimum impedance measurement value and the maximum impedance measurement value are extracted. The minimum impedance value is set as the X = 0 value on the graph, and the maximum impedance value is set as the maximum impedance value preceding the plateau. The y-axis representing the measured impedance values is scaled such that its maximum and minimum values match the maximum and minimum values.

[0039] In particular, when calibrating multiple electrodes on a 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) allows systematic adjustment of any distance-related effects. This facilitates the application of consistent corrections to all electrodes, tailored to their individual distances, and effectively rationalizes the calibration process. The adjustment for one electrode informs the adjustments required for other electrodes, making the process more efficient and ensuring consistency across the catheter.

[0040] According to the subject matter of the present disclosure, for a given electrode, when a scaled TPI response curve is obtained, two threshold points are determined for the electrode (blocks 405 and 407, e.g., by the TPI metric calculator 323 within the real-time proximity feedback engine 310). The first threshold represents the impedance value measured at baseline or during initial contact with tissue (indicated by the left arrow in FIG. 5), and the second threshold represents the impedance value measured just before the plateau of contact saturation (indicated by the right arrow in FIG. 5).

[0041] According to one embodiment, the first threshold can be determined based on some predetermined low percentile from the minimum value, and the second threshold can be determined based on some predetermined high percentile from the maximum value. For example, the first threshold can be set according to the 50th percentile, i.e., defining impedance measurements above this percentile as indicating contact. The second threshold can be set according to the 90th percentile, i.e., defining impedance measurements above this percentile as indicating contact saturation.

[0042] Following determination of the first and second thresholds, a respective graphical feature index is determined for each electrode (block 409, e.g., by a color-coding index generator 325 within the real-time proximity feedback engine 310). The graphical feature index is used to convert impedance values into respective graphical elements that visually represent different values, providing the physician with real-time graphical feedback regarding the proximity of the electrodes to the tissue wall of the luminal organ. The feedback provides the physician with information regarding the quality or degree of engagement (contact) between the catheter distal end and the tissue wall.

[0043] According to one embodiment, 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 respective colors that color the respective graphical elements representing the electrodes in a 3D graphical visualization of the catheter. In particular, the term color-coding is used to include, but is not limited to, any type of color model including a grayscale model, an RGB (red, green, blue) model, an HSV (hue, saturation, value) model, etc. Other possible types of graphical features include using different shapes, where different shapes are used to indicate different impedance values, and varying the blink frequency, where different blink frequencies are used to indicate different impedance values. The following description is made in relation to the color-coding index, but this is done by way of example only and it should be noted that other types of visual features are also contemplated within the scope of the subject matter of the present disclosure.

[0044] The color-coding index associates a first color with impedance values below a first threshold, a second color with impedance values above a second threshold, and a plurality of additional colors with respective impedance values (or ranges of values) between the first and second thresholds.

[0045] Since each electrode can have a different TPI response curve, the respective color - coding indices can also be different, i.e., different impedance values are associated with different colors. Therefore, in some embodiments, for each electrode, a color - coding scale is applied to a range of values between a first threshold and a second threshold.

[0046] For example, assuming a grayscale color is used, impedance values below the first threshold are represented by black, impedance values above the second threshold are represented by white, and the range of impedance values between the first threshold and the second threshold can be represented by a plurality of other gray shades in a color - coding scale evenly distributed within that range. Considering a non - limiting example where the range of impedance values is divided by a three - color color - coding scale with an even distribution, the impedance values within the range are divided into three, and can be associated with respective grayscale values 63, 127, and 191, where 0 represents the first threshold and 255 represents the second threshold. When the range of impedance values is divided by a five - color color - coding scale with an even distribution, the impedance values within the range are divided into five and can be associated with respective grayscale values 42, 85, 127, 170, and 212.

[0047] A graphical visualization of a catheter with a plurality of electrodes disposed thereon, which graphically represents the catheter, is generated (block 411). This can be done, for example, before or during a calibration procedure.

[0048] In some embodiments, a three-dimensional (3D) representation that graphically visualizes a catheter is generated with the aid of a catheter simulation module 311 and a rendering engine 313 that operate in relation to a CPU 301 and a GPU 305. The catheter simulation module 311 is configured to generate graphics that replicate the geometric shape, volume, surface topology, features, texture, etc. of the catheter. The graphics depict a catheter distal end assembly (e.g., a catheter basket) and graphical elements that also represent electrodes and optionally other components, so as to clearly show their arrangement and size. The rendering engine 313 is configured to render the graphics for display on a display device 27. In some embodiments, a graphical representation of the tissue wall surrounding the catheter is also provided.

[0049] An electrode color update module 327 within the real-time proximity feedback module 310 is configured to continuously receive impedance measurement values from each electrode and provide respective colors suitable for coloring the electrodes according to the impedance values measured in real time. The coloring of each electrode is provided to the GPU 305 and can thereby be used during the rendering of 3D graphics. During the initial generation of the 3D graphics, default values can be assigned to all the electrodes, for example, coloring all the electrodes black.

[0050] Following the calibration phase, an execution phase is initiated (block 430). During this phase, while the catheter is being manipulated within a luminal organ (e.g., the heart), each electrode continuously measures an impedance value (block 413). In response to changes in the impedance values measured by the electrodes, a coloring index is applied to select a matching color according to the updated impedance values (block 415).

[0051] Each time an impedance measurement value update is received, graphical elements representing each electrode at which the value was measured are re-rendered (block 417) using an updated color selected according to the most recently measured impedance value.

[0052] In some embodiments, the electrode color update module 327 receives a stream of impedance measurements and uses, for example, a color-coding index stored in the computer memory 303 to determine a matching color and provides the color to a rendering engine 313 that re-renders each graphical element using the matching color. The GPU can be configured to execute a shading program configured to color different graphic elements according to data received from the electrode color update module 327. The updated 3D visual representation of the catheter is displayed on the display device 27.

[0053] The operations associated with block 430 are continuously performed when the catheter is being manipulated within the luminal organ. This ensures that the 3D graphics are dynamically updated to reflect variations in the proximity of the electrodes to the tissue wall. As a result, this provides continuous real-time color feedback to the medical practitioner indicating the quality of the engagement between the catheter and the tissue wall.

[0054] During mapping of the inner surface of the luminal organ or during a medical procedure such as ablation when the catheter is being manipulated by a physician within the organ, the physician can look at the 3D catheter graphics displayed on the screen and use the color feedback of the catheter graphics generated in real time to bring the catheter into contact with the tissue, 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.

[0055] According to a first aspect of the subject matter of the present disclosure, a computer-implemented method for providing real-time visual feedback of intraluminal catheter engagement using a catheter comprising one or more electrodes disposed on a distal end assembly of the catheter, the method comprising: while the catheter is within a luminal organ of a patient, rendering a graphical representation of the distal end assembly of the catheter and one or more electrodes thereon on a display; for each of the one or more electrodes, identifying a range of impedance between a first threshold corresponding to baseline tissue contact and a second threshold corresponding to contact saturation for each of the one or more electrodes; defining a graphical feature index that associates impedance values within the defined range with respective visual features of the graphical representation of the one or more electrodes; repeatedly measuring impedance at each of the one or more electrodes; dynamically updating 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 intraluminal catheter engagement with the tissue wall. A computer-implemented method is provided.

[0056] In addition to the above features, the method according to this aspect of the subject matter of the present disclosure can optionally include one or more of the following features (i)-(vii) in any technically possible combination or permutation. i. The luminal organ is the patient's heart. ii. The distal end assembly is a basket comprising a plurality of splines, and the electrodes are distributed on the splines. iii. The method further comprises: acquiring a plurality of impedance values by the electrodes; identifying a maximum impedance value and a minimum impedance value; To obtain each impedance-proximity response curve, scaling the impedance-proximity response profile according to the maximum impedance value and the minimum impedance value, and determining a first threshold value and a second threshold value according to each impedance-proximity response curve, and further including defining each graphical feature index according to the first threshold value and the second threshold value. iv. Each graphical feature index includes a first visual feature representing an impedance value below a first threshold value corresponding to baseline tissue contact, a second visual feature representing an impedance value above a second threshold value corresponding to contact saturation, and a plurality of other visual features respectively representing a plurality of impedance values between the first threshold value and the second threshold value. v. The visual feature is color. vi. The visual feature is shading in grayscale. vii. The visual feature is the blinking rate.

[0057] According to a second aspect of the subject matter of the present disclosure, a graphical user interface (GUI) for providing real-time visual feedback of intraluminal catheter engagement using a catheter having one or more electrodes disposed on a distal end assembly of the catheter, the GUI comprising: rendering on a display a graphical representation of the distal end assembly of the catheter including one or more graphical elements, each graphical element graphically representing a respective one of the one or more electrodes, and each graphical element having assigned thereto a visual feature selected according to the measured impedance value; for each of the one or more electrodes, identifying a range of impedance between a first threshold value corresponding to baseline tissue contact and a second threshold value corresponding to contact saturation for each of the one or more electrodes, Defining a graphical feature index that associates impedance values within a defined range with respective visual features of a graphical representation of one or more electrodes Repeatedly receiving impedance measurement values measured by one or more electrodes, and in response to changes detected in the impedance values measured by the electrodes, updating in real time the respective visual features of the graphical representation of the electrodes based on the measured impedance and the graphical feature index, thereby providing dynamic visual feedback indicative of the quality of intravascular catheter engagement with tissue walls, and a graphical user interface (GUI) executable by a computer to perform the foregoing is provided.

[0058] The subject matter of the present disclosure further contemplates a computer system comprising at least one processing circuit configured to provide real-time visual feedback of intravascular catheter engagement, using a catheter comprising one or more electrodes disposed on a distal end assembly of the catheter as disclosed according to the first aspect above, wherein the system is operably connectable to a catheter-based electrophysiology mapping system.

[0059] The subject matter of the present disclosure further contemplates a computer system comprising at least one processing circuit configured to execute a method for enhancing intravascular catheter therapy (ICT) as disclosed according to the first aspect above, wherein the system is operably connectable to a catheter-based electrophysiology mapping system.

[0060] The subject matter of the present disclosure further 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 of providing real-time visual feedback of intraluminal catheter engagement using a catheter having one or more electrodes disposed thereon on a catheter distal end assembly disclosed according to the first aspect above.

[0061] The subject matter of the present disclosure further contemplates a computer program product including instructions that, when the program is executed by a computer, cause the computer to perform a method of enhancing intraluminal catheter therapy (ICT) disclosed according to the first aspect above.

[0062] The GUI, system, computer program product, and non-transitory program storage device can optionally include one or more of the features (i)-(vii) listed above, with necessary modifications, in any technically possible combination or permutation.

[0063] It will also be understood that a system according to the subject matter of the present disclosure can suitably be a programmed computer. Similarly, the subject matter of the present disclosure contemplates a computer program readable by a computer for performing the method of the subject matter of the present disclosure. The subject matter of the present disclosure further contemplates a machine-readable non-transitory memory tangibly embodying a program of instructions executable by a machine for performing the method of the subject matter of the present disclosure.

[0064] It should be understood that the subject matter of the present disclosure is not limited in its application to the details described in the description contained herein or illustrated in the drawings. The subject matter of the present disclosure can have other embodiments and can be practiced or implemented in various ways. Therefore, it should be understood that the expressions and terms used herein are for the purpose of description and should not be regarded as limiting. Thus, those skilled in the art will understand that the concepts on which the present disclosure is based can be readily utilized as a basis for designing other structures, methods, and systems for carrying out some of the objectives of the subject matter of the present disclosure.

[0065] 〔Embodiment〕 (1) A computer-implemented method for providing real-time visual feedback of intraluminal catheter engagement, using a catheter comprising one or more electrodes disposed on a distal end assembly of the catheter, comprising: while the catheter is within a luminal organ of a patient, rendering a graphical representation of the distal end assembly of the catheter and the one or more electrodes thereon on a display; for each of the one or more electrodes, identifying a range of impedance between a first threshold corresponding to baseline tissue contact and a second threshold corresponding to contact saturation for each of the one or more electrodes; defining a graphical feature index associating impedance values within the defined range with respective visual features of the graphical representation of the one or more electrodes; repeatedly measuring impedance at each of the one or more electrodes; dynamically updating 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 intraluminal catheter engagement with the tissue wall. (2) The computer-implemented method according to embodiment 1, wherein the luminal organ is the heart of the patient. (3) The computer-implemented method according to embodiment 1, wherein the distal end assembly is a basket having a plurality of splines, and the electrodes are distributed on the splines. (4) For each electrode, determining respective impedance-proximity response curves, acquiring a plurality of impedance values by the electrode, identifying a maximum impedance value and a minimum impedance value, scaling an impedance-proximity response profile according to the maximum impedance value and the minimum impedance value to obtain respective impedance-proximity response curves, determining the first threshold and the second threshold according to the respective impedance-proximity response curves, further including defining the respective graphical feature indexes according to the first threshold and the second threshold, the determining further including: the computer-implemented method according to embodiment 1. (5) Each of the graphical feature indexes includes a first visual feature representing an impedance value below a first threshold corresponding to baseline tissue contact, a second visual feature representing an impedance value above a second threshold corresponding to contact saturation, and a plurality of other visual features respectively representing a plurality of impedance values between the first threshold and the second threshold; the method according to embodiment 1.

[0066] (6) The computer-implemented method according to embodiment 1, wherein the visual feature is color. (7) The computer-implemented method according to embodiment 1, wherein the visual feature is shading in grayscale. (8) The computer-implemented method according to embodiment 5, wherein the visual feature is the blinking speed. (9) The computer-implemented method according to embodiment 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 intravascular catheter engagement, using a catheter having one or more electrodes disposed on a distal catheter assembly, the GUI comprising: rendering, on a display, a graphical representation of the distal catheter assembly including one or more graphical elements, each graphical element graphically representing a respective one of the one or more electrodes, and each graphical element being assigned a visual feature selected according to a measured impedance value; for each electrode of the one or more electrodes, identifying a range of impedance between a first threshold corresponding to baseline tissue contact and a second threshold corresponding to contact saturation for each of the one or more electrodes; defining a graphical feature index that associates impedance values within the defined range with respective visual features of the graphical representation of the one or more electrodes; repeatedly receiving impedance measurement values measured by the one or more electrodes and, in response to a change detected in the impedance value measured by the electrodes, updating in real time the respective visual features of the graphical representation of the electrodes based on the measured impedance and the graphical feature index, thereby providing dynamic visual feedback indicative of the quality of intravascular catheter engagement with the tissue wall, and being executable by a computer to perform.

[0067] (11) The visual feature is any one of color, shading in gray level, shape, and blinking rate, the GUI according to embodiment 10. (12) A computer system comprising at least one processing circuit configured to perform a method for providing real-time visual feedback of intravascular catheter engagement, using a catheter having one or more electrodes disposed on a distal end assembly of the catheter, the method comprising: while the catheter is within a luminal organ of a patient, rendering a graphical representation of the distal end assembly of the catheter and the one or more electrodes thereon on a display; for each of the one or more electrodes, identifying a range of impedance between a first threshold corresponding to baseline tissue contact and a second threshold corresponding to contact saturation for each of the one or more electrodes; defining a graphical feature index associating impedance values within the defined range with respective visual features of the graphical representation of the one or more electrodes; repeatedly measuring impedance at each of the one or more electrodes; dynamically updating 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 intravascular catheter engagement with the tissue wall. (13) The system of embodiment 12, operably connectable to a catheter-based electrophysiology mapping system comprising the catheter, wherein the luminal organ is the heart of the patient. (14) The system of embodiment 13, further comprising the catheter, wherein the distal end assembly is a basket comprising a plurality of splines, and the electrodes are distributed on the splines. (15) The system of embodiment 12, wherein the visual feature is any one of color, shading in gray level, shape, and blink rate.

[0068] (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 for providing real-time visual feedback of intraluminal catheter engagement using a catheter having one or more electrodes disposed on a distal catheter assembly, the method comprising: while the catheter is within a patient's luminal organ, rendering a graphical representation of the distal catheter assembly and the one or more electrodes thereon on a display; for each of the one or more electrodes, identifying a range of impedances between a first threshold corresponding to baseline tissue contact and a second threshold corresponding to contact saturation for each of the one or more electrodes; defining a graphical feature index that associates impedance values within the defined range with respective visual features of the graphical representation of the one or more electrodes; repeatedly measuring impedance at each of the one or more electrodes; dynamically updating 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 intraluminal catheter engagement with the tissue wall. A non-transitory computer-readable storage medium.

Claims

1. A graphical user interface (GUI) for providing real-time visual feedback of intraluminal catheter engagement using a catheter having one or more electrodes disposed on a distal end assembly of the catheter, the GUI comprising: rendering on a display a graphical representation of the distal end assembly of the catheter including one or more graphical elements, each graphical element graphically representing a respective one of the one or more electrodes, and each graphical element having assigned a visual characteristic selected according to a measured impedance value; for each of the one or more electrodes, identifying a range of impedance between a first threshold corresponding to baseline tissue contact and a second threshold corresponding to contact saturation for each of the one or more electrodes; defining a graphical feature index that associates impedance values within the defined range with respective visual characteristics of the graphical representation of the one or more electrodes; repeatedly receiving impedance measurement values measured by the one or more electrodes and, in response to a change detected in the impedance value measured by the electrodes, updating in real time the respective visual characteristics of the graphical representation of the electrodes based on the measured impedance and the graphical feature index, thereby providing dynamic visual feedback indicative of the quality of intraluminal catheter engagement with the tissue wall, the graphical user interface (GUI) being executable by a computer to perform the foregoing.

2. The visual characteristic is any one of color, shading in gray levels, shape, and blink rate, the GUI according to claim 1.

3. A computer system comprising at least one processing circuit configured to execute a method for providing real-time visual feedback of intraluminal catheter engagement using a catheter having one or more electrodes disposed on a distal end assembly of the catheter, the method comprising: while the catheter is within a patient's luminal organ, Rendering a graphical representation of the catheter distal end assembly and the one or more electrodes thereon on a display; For each of the one or more electrodes; For each of the one or more electrodes, identifying a range of impedances 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 the defined range with respective visual features of the graphical representation of the one or more electrodes; Repeatedly measuring impedance at each of the one or more electrodes; Dynamically updating 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 intraluminal catheter engagement with the tissue wall. A computer system comprising: **Claim 4** The system of claim 3, operably connectable to a catheter-based electrophysiology mapping system comprising the catheter, wherein the luminal organ is the patient's heart. **Claim 5** The system of claim 4, further comprising the catheter, wherein the distal end assembly is a basket comprising a plurality of splines, and the electrodes are distributed on the splines. **Claim 6** The system of claim 3, wherein the visual feature is any one of color, shading in gray level, shape, and blink rate. **Claim 7** 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 comprising one or more electrodes disposed on a catheter distal end assembly, the method comprising: While the catheter is within a luminal organ of a patient, Rendering a graphical representation of the catheter distal end assembly and the one or more electrodes thereon on a display; For each of the one or more electrodes; For each of the one or more electrodes, identifying a range of impedance 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 the defined range with respective visual features of the graphical representation of the one or more electrodes; repeatedly measuring impedance at each of the one or more electrodes; dynamically updating 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 intravascular catheter engagement with the tissue wall. A non-transitory computer-readable storage medium comprising: **Claim 8** A computer-implemented method for providing real-time visual feedback of intravascular catheter engagement using a catheter comprising one or more electrodes disposed on a distal catheter assembly, the method comprising: while the catheter is within a patient's lumen organ, rendering a graphical representation of the distal catheter assembly and the one or more electrodes thereon on a display; for each electrode of the one or more electrodes, identifying a range of impedance between a first threshold corresponding to baseline tissue contact and a second threshold corresponding to contact saturation for each of the one or more electrodes; defining a graphical feature index that associates impedance values within the defined range with respective visual features of the graphical representation of the one or more electrodes; repeatedly measuring impedance at each of the one or more electrodes; dynamically updating 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 intravascular catheter engagement with the tissue wall. A computer-implemented method comprising: **Claim 9** The computer-implemented method of claim 8, wherein the lumen organ is the patient's heart. **Claim 10** The distal end assembly is a basket with a plurality of splines, and the electrodes are distributed on the splines. The computer-implemented method according to claim 8.

11. For each electrode, determining a respective impedance-proximity response curve, acquiring a plurality of impedance values by the electrode, identifying a maximum impedance value and a minimum impedance value, scaling an impedance-proximity response profile according to the maximum impedance value and the minimum impedance value to obtain a respective impedance-proximity response curve, determining the first threshold value and the second threshold value according to the respective impedance-proximity response curves, defining the respective graphical feature indices according to the first threshold value and the second threshold value. The computer-implemented method according to claim 8, further including the determining.

12. Each of the graphical feature indices includes a first visual feature representing an impedance value below a first threshold corresponding to baseline tissue contact, a second visual feature representing an impedance value above a second threshold corresponding to contact saturation, and a plurality of other visual features each representing a respective impedance value between the first threshold and the second threshold. The method according to claim 8.

13. The visual feature is color. The computer-implemented method according to claim 8.

14. The visual feature is shading in grayscale. The computer-implemented method according to claim 8.

15. The visual feature is the blinking rate. The computer-implemented method according to claim 12.

16. Rendering a graphical representation of the luminal organ on the display. The computer-implemented method according to claim 8.

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