Method and system for assisting user in guiding catheter during cardiac operation

Abstract

To guide a user navigating a catheter.SOLUTION: The present invention relates to a method, an apparatus and a computer program product, the method comprising: obtaining electrical information from a plurality of electrodes disposed on a distal end assembly of a catheter within a heart of a patient as the catheter is being maneuvered within the heart; dynamically identifying a portion of the distal end assembly that is displaced from a tissue wall of the heart, based upon the electrical information received from the plurality of electrodes; generating a visual representation of the distal end assembly; dynamically distorting the visual representation by warping the identified portion of the distal end assembly; and rendering the visual representation as dynamically distorted to a display device.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present disclosure relates generally to medical applications and, more particularly, to a user interface for guiding a user in navigating a catheter. [Background technology]

[0002] Many cardiac disorders may be diagnosed and / or treated using catheters, which may be selected according to the task, e.g., diagnostic catheter, ablation catheter, or another catheter type.

[0003] Arrhythmias may be caused, for example, by problems with the electrical conduction system of the heart, particularly electrical activity at one or more points or regions in the walls of the heart chambers. Atrial fibrillation is an arrhythmia characterized by disorganized signals that cause the atria (left and / or right atria) to contract in a very rapid, asynchronous heart rhythm.

[0004] A common treatment for atrial fibrillation, also known as A-fib, is ablation, which uses energy to create scars in one or more active areas of the heart wall to interrupt erroneous electrical signals that contribute to the chaotic signal and restore a typical heartbeat. It may be advantageous to build an electroanatomical model of the heart chamber and also track the position of a catheter within the modeled chamber. Additionally or alternatively, fluoroscopy may be used to determine the current position of the catheter so that ablation can be applied where it will be most effective. [Brief explanation of the drawings]

[0005] A more complete understanding of the present disclosure will be obtained from the following detailed description of the embodiments of the present disclosure when read in conjunction with the drawings. [Figure 1] 1 is a schematic, pictorial illustration of a catheter-based electrophysiological (EP) mapping and ablation system, according to some exemplary embodiments of the present disclosure; [Figure 2]1A-1C are schematic, pictorial diagrams illustrating examples of catheter distal head assemblies, according to some exemplary embodiments of the present disclosure. [Figure 3] 10A-10C are diagrams of exemplary virtual representations of a distal end assembly of a catheter that are displayed to a user while the distal end assembly is positioned at a first position within the heart, according to some exemplary embodiments of the present disclosure. [Figure 4A] 1A-1C are diagrams of exemplary virtual representations of a distal end assembly of a balloon-type catheter, according to some exemplary embodiments of the present disclosure. [Figure 4B] 10A-10C are diagrams of exemplary virtual representations of a distal end assembly of a balloon-type catheter displayed to a user while the distal end assembly is positioned at a second position within the heart, according to some exemplary embodiments of the present disclosure. [Figure 5] 1 is a flowchart of steps in a method for guiding a user in navigating a catheter during cardiac surgery, according to some exemplary embodiments of the present disclosure. [Figure 6] FIG. 1 is a schematic block diagram of a computing platform for guiding a user in navigating a catheter during cardiac surgery, according to some exemplary embodiments of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0006] In the following detailed description, numerous specific details are set forth in order to provide a thorough understanding of the present invention. However, it will be apparent to those skilled in the art that the present invention may be practiced without these specific details. In other embodiments, well-known circuits, control logic, and details of computer program instructions for conventional algorithms and processes are not shown in detail in order to avoid unnecessarily obscuring the present invention.

[0007] Software programming code embodying aspects of the present invention is typically maintained in permanent storage, such as a computer-readable medium. In a client-server environment, such software programming code may be stored on either the client or the server. The software programming code may be embodied in any of a variety of well-known media for use with data processing systems, including, but not limited to, magnetic and optical storage devices, such as disk drives, magnetic tape, compact discs (CDs), digital video discs (DVDs), and computer instruction signals embodied in a transmission medium, with or without a carrier wave upon which the signals are modulated. For example, the transmission medium may include a communications network, such as the Internet. It should be noted that, while the present invention may be embodied in computer software, the functionality required to carry out the present invention may alternatively be embodied, in part or entirely, using hardware components, such as application-specific integrated circuits or other hardware, or some combination of hardware components and software.

[0008] Overview When using a catheter to perform diagnostic and / or ablation procedures, a physician must manipulate the catheter's distal end assembly within the heart chamber to map the chamber and / or reach a location of interest, such as a pulmonary vein (PV), and care must be taken to avoid compressing the tissue wall with excessive pressure.

[0009] Prior to mapping, or in the absence of mapping, the physician may have no visual guidance as to where to manipulate the catheter. Traditionally, fluoroscopy is used to provide real-time imaging and tracking of target movement in the form of video of the heart and its movement. Fluoroscopy passes x-rays through the body over a period of time, and naturally, the longer the procedure, the higher the dose of radiation that must be applied. It will be appreciated that fluoroscopy involves risks not only to the patient, but also to staff, including the physician.

[0010] Therefore, it would be beneficial to guide a physician to a target location(s) within a heart chamber without or with significantly reduced use of fluoroscopy or other methods involving radiation or harmful substances.

[0011] Thus, embodiments of the present disclosure provide systems and methods for assisting physicians in navigating a catheter within a heart chamber and / or to a target location within a heart chamber, e.g., a location designated for treatment, such as a passageway from the atrium to the PV.

[0012] In some embodiments, a distal tip assembly of a catheter, e.g., a diagnostic and / or therapeutic catheter, may have an expandable configuration in the form of a balloon or basket with multiple splines. The distal tip assembly may include multiple electrodes distributed in a 3D configuration, e.g., each spline of a basket-type catheter may support one or more electrodes.

[0013] The electrodes may be connected to circuitry configured to track impedance in the vicinity of each of the plurality of electrodes in real time as the physician navigates with the catheter. Optionally, a Tissue Proximity Index (TPI) for each of the plurality of electrodes may be tracked based on the impedance measurements.

[0014] When navigating the catheter within a cardiac chamber, for example within a PV, it is desirable that the distal end assembly not press against the cardiac wall with excessive force, but rather advance toward the interior space of the ventricle, also referred to hereinafter as the void space.

[0015] In accordance with the present disclosure, in the absence of appropriate anatomical information, e.g., a model, map, or image of the cavity and the position of the distal tip assembly relative to the cavity anatomy, a virtual representation of the distal tip assembly may be displayed to the user via a display device. The visual representation may be visually manipulated in a manner to indicate the direction in which the catheter may be steered to avoid a tenting effect in which the catheter's distal tip assembly presses against the heart wall and advance away from the wall and into the cavity. For example, the representation may include a distortion of the distal tip assembly to indicate the direction.

[0016] In some embodiments, the distal tip assembly may be displayed in a schematic, deformed manner. For example, in a basket-type catheter, the display may show the same number of splines as are included in the distal tip assembly of the catheter, with one or more splines distorted, e.g., elongated, enlarged, or "pulled," in the direction in which the distal tip assembly should be moved. In the case of a balloon-type catheter, the general shape may be "squashed" in one or more regions, e.g., contracted or narrowed. Thus, the display may "direct" the user to navigate the catheter away from the heart wall in any direction possible. A map of the heart may or may not be displayed with the distal tip assembly shown therein.

[0017] In some embodiments, an estimated contour of the wall may be drawn as mapping points are collected by the distal end assembly.

[0018] Thus, the distal tip assembly is depicted schematically and deformed, e.g., one or more splines are distorted, so that it is optionally displayed in an unrealistic manner, which, of course, would not occur with real splines, but which suggests to the user how to steer the catheter to the required position.

[0019] In some embodiments, deformation may only be performed when the catheter is moving and avoided when it is stationary, thus allowing the user to get guidance when moving the catheter, but indicating in a more realistic way when it has reached the required position or stopped.

[0020] In some embodiments, the transformation may be performed according to user preferences or settings, whereby the user may toggle this feature according to the user's preferences, which may change over the course of operation.

[0021] System Description Refer to FIG. 1 , which illustrates an exemplary catheter-based electrophysiology mapping and ablation system 10. The system 10 includes multiple catheters that can be percutaneously inserted by a physician 24 through the vascular system of a patient 23 and into a chamber or vasculature of a heart 12. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location in the heart 12. One or more catheters may then be inserted into the delivery sheath catheter to reach a desired location within the heart 12. The multiple catheters may include catheters dedicated to sensing intracardiac electrogram (IEGM) signals, catheters dedicated to ablation, and / or catheters dedicated to both sensing and ablation. An exemplary catheter 14 is illustrated herein. The physician 24 may place a distal end assembly 28 of the catheter 14 in the blood pool or in contact with the heart wall to sense different sites within the heart 12. For example, when performing ablation, the physician 24 may contact the distal tip of the ablation catheter with a target site where tissue is to be ablated.

[0022] The term distal tip may be used interchangeably with the term distal end assembly.

[0023] The distal tip assembly 28 of the catheter 14 may include a plurality of electrodes 26, optionally distributed across a plurality of splines 22, configured to sense IEGM signals and / or apply ablation energy to a location. The catheter 14 may further include a position sensor 29 embedded in or near the distal tip assembly 28 for tracking the position and orientation of the distal tip assembly 28. Optionally and preferably, the position sensor 29 is a magnetic-based position sensor including three magnetic coils for sensing three-dimensional (3D) position and orientation.

[0024] The magnetic-based position sensor 29 may operate in conjunction with a location pad 25 that includes a plurality of magnetic coils 32 configured to generate a magnetic field within a predetermined working volume. The real-time position of the distal end assembly 28 of the catheter 14 may be tracked based on the magnetic fields generated by the location pad 25 and sensed by the magnetic-based position sensor 29. Details of magnetic-based position sensing technology are described in U.S. Patent Nos. 5,5391,199; 5,443,489; 5,558,091; 6,172,499; 6,239,724; 6,332,089; 6,484,118; 6,618,612; 6,690,963; 6,788,967; and 6,892,091.

[0025] Additionally or alternatively, system 10 may include one or more electrode patches 38 positioned for skin contact on patient 23 to establish a position reference for location pads 25 and impedance-based tracking of electrodes 26. For impedance-based tracking, current is directed to electrodes 26 and sensed at electrode skin patches 38, thereby triangulating the position of each electrode via 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.

[0026] Recorder 11 may record and display electrograms 21 captured by body surface ECG electrodes 18 and IEGMs captured by electrodes 26 on catheter 14. Recorder 11 may include pacing capability for pacing the cardiac rhythm and / or may be electrically connected to a stand-alone pacer.

[0027] The system 10 may include an ablation energy generator 50 adapted to deliver ablation energy to one or more electrodes at a distal tip assembly of a catheter configured for ablation. The energy generated by the ablation energy generator 50 may include, but is not limited to, radiofrequency (RF) energy or pulsed-field ablation (PFA) energy, including unipolar or bipolar high-voltage DC pulses, such as may be used to effect irreversible electroporation (IRE), or a combination thereof.

[0028] A Patient Interface Unit (PIU) 30 may be configured to establish electrical communication between the catheters, other electrophysiology equipment, a power source, and a workstation 55 that controls the operation of the system 10. The electrophysiology equipment of the system 10 may include, for example, multiple catheters, location pads 25, body surface ECG electrodes 18, electrode patches 38, an ablation energy generator 50, and a recorder 11. Optionally and preferably, the PIU 30 additionally includes processing capability to implement real-time calculations of catheter position and perform ECG calculations.

[0029] The workstation 55 includes a processor unit having memory, a memory or storage device having appropriate operating software stored therein, and user interface functionality. The workstation 55 may provide multiple functions, including modeling the current position and orientation of the catheter or its distal end assembly, determining the absolute or relative distance of each electrode from the tissue, calculating deformation of one or more portions of the distal end assembly, and, if applicable and desired by the user, displaying a schematic diagram 20 of the catheter or its distal end assembly, including the deformation, on a display device 27. In some embodiments, the contours of tissue, such as the heart wall, as estimated by the distance of the electrodes therefrom, may also be displayed. One commercially available product embodying elements of the system 10 is available as the CARTO™ 3 system, commercially available from Biosense Webster, Inc., 31A Technology Drive, Irvine, CA 92618.

[0030] 2, a schematic diagram of a particular distal tip assembly 28 is shown, according to some exemplary embodiments of the present disclosure. Distal tip assembly 28 includes ten splines, such as splines 204, 208, 212, 216, 220, and 224 (all similar to splines 22 of FIG. 1), each supporting several electrodes 26. It will be understood that catheter 14 and distal tip assembly 28 are exemplary only, and that the present disclosure is equally applicable to other types of catheters.

[0031] Referring now to FIG. 3, an illustration 20 is shown that may be presented to a user via a display device 27 during operation, according to some exemplary embodiments of the present disclosure.

[0032] Currently, an accurate map of a region of the heart is not available without the use of fluoroscopy or similar techniques. Rather, an estimated map may be displayed or obtained based, for example, on prior knowledge, the distance of the electrodes from the walls and known geometric relationships between the electrodes, previously applied fluoroscopy, etc. Thus, walls 300 and 304 represent a two-dimensional projection of the estimated shape of the region in which distal end assembly 28 currently resides.

[0033] 3, distal end assembly 28 is closer to protruding wall 300 than to protruding wall 304 and therefore needs to be steered by the physician in the direction of arrow 308 to move from the narrower area to the larger space. Accordingly, the shape of one or more of the splines, such as splines 204, 208, and 212, may be distorted to indicate to the user the direction the catheter should be steered in to stay away from the heart wall and advance toward the larger space, i.e., void. It will be understood that arrow 308 may or may not be part of FIG. 20.

[0034] Thus, spline 204 is distorted to some extent toward wall 304, and splines 208, 212, and 220 are gradually distorted such that the splines appear to be "pulled" in the direction that distal end assembly 28 should be pointed.

[0035] It will be understood that the actual shape of the distal end assembly 28 remains unchanged and that it is merely a visualization that is manipulated to orient the user in a desired direction, without an exact map of the heart and the exact location of the distal end assembly 28 therein.

[0036] It will be appreciated that this is just an example and other representations may be used, for example the spline may be distorted in the opposite direction to appear closer to the wall and should be steered away.

[0037] In further embodiments, one or more arrows may be displayed adjacent to the visual representation of the distal tip assembly, and the arrows may indicate required or possible directions instead of, or in addition to, distorting the visual representation of the distal tip assembly, etc.

[0038] Reference is now made to Figures 4A and 4B. Figure 4A illustrates a balloon catheter distal end assembly 404, according to some exemplary embodiments of the present disclosure. Figure 4B illustrates an exemplary virtual representation of a balloon catheter distal end assembly 408, according to some exemplary embodiments of the present disclosure, that may appear to a user when passing through a narrow area. Thus, the balloon catheter distal end assembly 408 appears the same as the balloon catheter distal end assembly 404 when passing through the narrow area. The area may be surrounded by walls projected as walls 408 and 412. To prevent the physician from pressing against the walls, the balloon catheter distal end assembly 408 is squashed, e.g., flattened or narrowed in its center, thus suggesting that up and down movement is possible. Therefore, arrows 420 and 424 are optionally displayed to indicate these directions.

[0039] Thus, by viewing the illustrated distal end of the distal tip assembly, a user can perceive the position and orientation of the distal tip assembly relative to the surrounding tissue, and therefore relative to the available directions in which the catheter may be steered, without having to use fluoroscopy.

[0040] It will be appreciated that the present method may be used during portions of the procedure such that fluoroscopy may be used for shorter periods, thereby reducing the amount of radiation and risk to the patient and staff. For example, fluoroscopy may be used only when there is a need to navigate in a smaller area, such as when reaching the ablation site.

[0041] Referring now to FIG. 5, there is shown a flowchart of steps in a method for guiding a catheter user during cardiac surgery, according to some exemplary embodiments of the present disclosure.

[0042] In step 500, electrical information such as impedance or TPI may be obtained from multiple electrodes disposed on the distal tip assembly of the catheter. Impedance may be measured based on transmitting a signal between electrodes on the distal tip assembly or based on transmitting a signal between an electrode on the distal tip assembly and a reference electrode. The reference electrode may be located on the distal tip assembly of the catheter shaft or on the patient's skin. The catheter may be any basket-type catheter, balloon-type catheter, or expandable catheter.

[0043] In step 504, portions of the distal tip assembly that are displaced from the tissue wall may be identified based on the electrical information. In some embodiments, the distance between each electrode and the nearest tissue may be determined, and one or more portions may be selected based on the distance. In some embodiments, the distance may be absolute, e.g., mm, microns, etc., and the distance of the nearest electrode to the tissue wall must exceed a predetermined threshold. In other embodiments, the distance may be relative, e.g., the distance between the farthest electrode and the nearest location on the tissue may be 1.7 times the distance between the next-farthest electrode and the corresponding nearest location. It will be appreciated that distances may be calculated for groups of electrodes, as several electrodes may be adjacent to each other.

[0044] In step 508, a visual representation of the distal tip assembly may be obtained. The representation may be dynamically calculated, retrieved from a storage device, pre-created and loaded, or otherwise.

[0045] The display may be three-dimensional, whereby the display is projected onto a two-dimensional plane, but when the user rotates the view, the display automatically updates to show the projection onto the changing view plane.

[0046] The display may be schematic, for example, in a basket-type catheter, the correct number of splines may be displayed along with an indication of the electrodes, such as circles marked in proportional positions on the splines.

[0047] In step 512, the representation may be distorted, for example, by distorting at least the displaced portion of the distal tip assembly. Distorting may refer to stretching or expanding the relevant portion. For example, one or more of the splines of a basket-type catheter may be distorted and may appear to be pulled in the direction the catheter is to be moved, whether toward a void or toward tissue. In another example, the shape of a balloon-type catheter may be compressed, for example, by narrowing or contracting it.

[0048] It will be appreciated that the splines of a basket-style catheter may be distorted at different angles and to different degrees, as shown, for example, in Figure 3, where spline 204 is bent at a larger, sharper angle than spline 208. The degree and direction of deformation may be determined based on the proximity of the spline direction to the desired direction, the distance from the wall, etc.

[0049] In another example, the balloon catheter may appear partially or completely collapsed to indicate its proximity to the wall.

[0050] In step 516, the display may be rendered on a display device, including projecting the three-dimensional information onto a two-dimensional plane.

[0051] In some examples, based on the distance, an available direction in which the catheter may be steered is determined, e.g., calculated. This direction should be toward the cavity and / or the direction in which the distal tip assembly of the catheter is free to advance. In some exemplary embodiments, the determined direction may be toward the ostium of a pulmonary vein. In other situations, for example, when a user wishes to perform an ablation, the direction determined based on the distance may be a direction in which to steer the distal tip assembly toward tissue.

[0052] In some embodiments, the contours of the tissue near the catheter may be estimated based on the distance from the electrodes and rendered as well to allow the user to get a sense of the location of the catheter relative to the wall. In some embodiments, estimating the contours of the tissue may also use prior knowledge about the structure of the patient's heart, which may have been previously acquired.

[0053] In some embodiments, the distorted distal tip assembly may be rendered on a display together with fluoroscopy. The distorted distal tip assembly may be rendered together with an anatomical map to provide guidance to the user regarding the direction in which the catheter should be steered.

[0054] The user may have the option enabled through the user interface whether to eliminate the warped view option and continue to use fluoroscopy or other methods, or whether to use this option to indicate direction. It will be understood that the user can toggle this option on and off as the user desires.

[0055] In some embodiments, the user may also select whether this option is activated continuously or only when the catheter is being moved.

[0056] In some embodiments, if the user wishes to use the option, the user may also indicate whether the user wishes to distort the display of the catheter so that the catheter appears to be directed toward the void or toward the tissue.

[0057] If an anatomical map is available, the distal end assembly may be represented at its exact location on the map, for example, as obtained from electrodes 29.

[0058] In some embodiments, an audio indication may be played to alert the physician if the distal tip assembly is estimated to be too close, for example, if the distance between the distal tip assembly and the heart wall is below a threshold, or even if the distal tip assembly is pressing against the heart wall.

[0059] It will be appreciated that the present disclosure may also be used for mapping purposes. When mapping, it is necessary to collect location information for points within the cavity and along the tissue wall while avoiding tenting, which can occur if the distal tip assembly pushes against the tissue wall. When collecting points in this situation, the cavity appears larger than it would due to stretching. Therefore, it is important to visually indicate to the user the direction in which the distal tip assembly can be moved without compressing the tissue wall.

[0060] Referring now to FIG. 6, there is shown a block diagram of a computing platform 600 for guiding a user in navigating a catheter during cardiac surgery, according to some exemplary embodiments of the present disclosure.

[0061] It will be appreciated that computing platform 600 may be embedded within workstation 55, but may also be a stand-alone computing platform, or may be embedded elsewhere and in operative communication with workstation 55.

[0062] Computing platform 600 may be implemented as one or more computing platforms that may be operatively connected to one another. For example, one or more remote computing platforms may be implemented, for example, on a cloud computer. Other computing platforms may be part of an associated organizational computer network. In other embodiments, all functionality may be provided by one or more computing platforms that are all part of the organizational network.

[0063] Computing platform 600 may include one or more processors 604, which may or may not be located on the same computing platform, and which may be one or more central processing units (CPUs), microprocessors, electronic circuits, integrated circuits (ICs), etc. Processor 604 may be configured to provide the required functionality by, for example, loading into memory and activating software modules stored in storage device 612, which will be described in more detail below.

[0064] The computing platform 600 may include a communications device 608 for communicating with other devices or other computing platforms, e.g., retrieving information from a catheter procedure controller, storing and retrieving data to and from a remote storage device, etc. The communications module 608 may be adapted to interface with any communications channel, such as a local area network (LAN), a wide area network (WAN), a cellular network, etc., and to use any associated communications protocol.

[0065] Computing platform 600 may include a storage device 612, such as a hard disk drive, flash disk, random access memory (RAM), memory chips, etc. In some exemplary embodiments, storage device 612 may hold program code operable to cause processor 604 to perform operations associated with any of the modules listed below or steps of the method of Figure 5 above. The program code may include one or more executable units, such as functions, libraries, stand-alone programs, etc., adapted to execute instructions, as detailed below.

[0066] Alternatively or additionally, the provided instructions may be stored on a non-transitory, tangible computer-readable medium, such as magnetic, optical, or electronic memory.

[0067] The storage device 612 may also include a display and I / O (Input / Output) module 616 for rendering to the user displays to be displayed on the display device 27, such as an illustration of the catheter or its distal end assembly, wall contours, and an anatomical map if available.

[0068] The display and I / O module 616 may further be operable to receive commands and operating parameters from the user, such as to activate the catheter display or alternatively use fluoroscopy (or other methods), distort splines constantly or only when the catheter is moving, deform the catheter toward a gap or tissue, etc.

[0069] The storage device 612 may include a communications module 620 for transmitting and receiving data to and from the ablation system and other systems, such as external storage devices. For example, the communications module 620 may operate to receive information from various electrodes, such as impedance, TPI, etc.

[0070] The storage device 612 may include a distance calculation and selection module 624 for calculating the distance between each portion of the distal tip assembly, such as an electrode, a group of electrodes, one or more splines, etc., and the nearest point in the tissue. The distance may be absolute or relative. It will be appreciated that because some electrodes may be adjacent to each other, the distance may be calculated for a group of electrodes collectively referred to as an "electrode." Based on the distance, the portion of the distal tip assembly farthest from the tissue wall may be selected.

[0071] The storage device 612 may include a display acquisition module 628 for generating a visual representation of the distal tip assembly. The visual representation may be calculated earlier during operation, dynamically calculated, received from a storage device, or otherwise.

[0072] The storage device 612 may include a deformation calculation module 632. The deformation calculation module 628 may be configured to determine whether and how to deform at least a portion of the distal tip assembly farthest from the tissue wall; for example, in the case of a basket-type catheter, the deformation calculation module 632 may determine the degree, direction, and location of distortion on one or more of the splines according to the distance and direction of the electrodes from the tissue. For example, it will be appreciated that the spline having the electrode farthest from the tissue and closest to the void may be deformed such that it is distorted toward the void and "pulls" the catheter in that direction; thus, two or more splines may be distorted in different ways or degrees.

[0073] In some embodiments, the spline on which the electrode in contact with the tissue is located may appear flat to indicate that it is pressed against the tissue.

[0074] The display calculation module 628 may further be configured to calculate the wall contour according to the distance of the electrodes from the tissue and the known spatial relationship between the locations of the electrodes.

[0075] The storage device 612 may include a direction calculation module 636 for determining the direction in which the catheter should be steered.

[0076] The storage device 612 may include a rendering module 640 for rendering a representation of the deformed portion and, optionally, the catheter with tissue contours, directional arrows, a map of the cardiac chambers, etc., on a 2D device.

[0077] The storage device 612 may also include a data and control flow management module 644 for operating the above modules as needed, for example, providing a modified display when the user indicates a desire to use a user interface control and avoiding it otherwise, modifying the catheter diagram according to the user's preferences, etc.

[0078] It will be understood that the steps and modules disclosed above are in addition to any software, hardware, firmware, or other modules required to operate the catheter, etc. Further details regarding methods and systems can be found, for example, in U.S. Patent Nos. 8,676,305 and 9,629,567, which are incorporated herein by reference in their entirety for any purpose.

[0079] The present invention may be a system, a method, and / or a computer program product. The computer program product may include a computer-readable storage medium having computer-readable program instructions for causing a processor to perform aspects of the present invention.

[0080] A computer-readable storage medium may be a tangible device that can hold and store instructions for use by an instruction execution apparatus. The computer-readable storage medium may be, for example, but not limited to, an electronic storage device, a magnetic storage device, an optical storage device, an electromagnetic storage device, a semiconductor storage device, or any suitable combination of the foregoing. A non-exhaustive list of more specific examples of computer-readable storage media includes portable computer diskettes, hard disks, random access memory (RAM), read-only memory (ROM), erasable programmable read-only memory (EPROM or flash memory), static random access memory (SRAM), portable compact disc read-only memory (CD-ROM), digital versatile disk (DVD), memory sticks, floppy disks, mechanically encoded devices such as punch cards or ridge-in-groove structures with instructions recorded on them, and any suitable combination of the above. As used herein, computer-readable storage medium should not be construed as being a signal that is itself ephemeral, such as an electric wave or other freely propagating electromagnetic wave, an electromagnetic wave propagating through a waveguide or other transmission medium (e.g., a light pulse passing through a fiber optic cable), or an electrical signal transmitted through a current line.

[0081] The computer-readable program instructions described herein may be downloaded from a computer-readable storage medium to each computing / processing device or to an external computer or external storage device via a network, such as the Internet, a local area network, a wide area network, and / or a wireless network. The network may include copper transmission cables, fiber optic transmissions, wireless transmissions, routers, firewalls, switches, gateway computers, and / or edge servers. A network adapter card or network interface in each computing / processing device receives the computer-readable program instructions from the network and forwards the computer-readable program instructions to a computer-readable storage medium within the respective computing / processing device for storage.

[0082] The computer-readable program instructions for carrying out the operations of the present invention may be either assembler instructions, instruction set architecture instructions, machine instructions, machine-dependent instructions, microcode, firmware instructions, state setting data, or source or object code written in any combination of one or more programming languages, such as Java, C, C++, Python, etc. The computer-readable program instructions may be executed entirely on the user's computer, partially on the user's computer, as a stand-alone software package, partially on the user's computer, partially on a remote computer, or entirely on a remote computer or server. In the latter scenario, the remote computer may be connected to the user's computer via any type of network, including a local area network (LAN) or a wide area network (WAN), or may be connected to an external computer (e.g., via the Internet using an Internet Service Provider). In some embodiments, electronic circuitry including, for example, programmable logic circuitry, a field-programmable gate array (FPGA), or a programmable logic array (PLA), may execute computer-readable program instructions by utilizing state information in the computer-readable program instructions to individualize the electronic circuitry to perform aspects of the present invention.

[0083] Aspects of the present invention are described herein with reference to flowchart and / or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart and / or block diagrams, and combinations of blocks in the flowchart and / or block diagrams, can be implemented by computer-readable program instructions.

[0084] These computer-readable program instructions can be provided to a processor of a general-purpose computer, special-purpose computer, or other programmable data processing device such that the instructions, when executed by the processor of the computer or other programmable data processing device, create a machine that performs the functions / acts specified in one or more blocks of the flowcharts and / or block diagrams. These computer-readable program instructions can also be stored on a computer-readable storage medium that can cause a computer, programmable data processing apparatus, and / or other device to function in a particular manner, whereby the computer-readable storage medium on which the instructions are stored includes an article of manufacture that includes instructions that implement aspects of the functions / acts specified in one or more blocks of the flowcharts and / or block diagrams.

[0085] The computer-readable program instructions may be loaded onto a computer, other programmable data processing apparatus, or other device to cause a series of operational steps to be implemented on the computer, other programmable apparatus, or other device to generate a computer-implemented process such that the instructions, executed on the computer, other programmable apparatus, or other device, perform the functions / acts defined in the flowchart and / or block diagram blocks.

[0086] The flowcharts and block diagrams in the figures illustrate the structure, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present invention. In this regard, each block in a flowchart or block diagram may represent a module, segment, or portion of instructions, including one or more executable instructions for implementing the depicted logical function(s). In some alternative implementations, the functions depicted in the blocks may occur out of the order depicted in the figures. For example, two blocks shown in succession may in fact be executed substantially concurrently, or the blocks may, in some cases, be executed in the reverse order, depending on the functionality involved. It should also be noted that each block of the block diagrams and / or flowcharts, and combinations of blocks in the block diagrams and / or flowcharts, may be implemented by a dedicated hardware-based system that performs the specified functions or operations, or may be operated or executed by a combination of dedicated hardware and computer instructions. [Example]

[0087] Example 1 1. A method, comprising: acquiring electrical information from a plurality of electrodes disposed on a distal end assembly of a catheter within a patient's heart as the catheter is manipulated within the heart; dynamically identifying a portion of the distal tip assembly that is displaced from a tissue wall of the heart based on the electrical information received from the plurality of electrodes; generating a visual representation of the distal tip assembly; dynamically modifying the visual representation by distorting the identified portion of the distal tip assembly; and rendering the visual representation as dynamically transformed on the display device.

[0088] Example 2 2. The method of example 1, wherein the portion is identified as being displaced from the tissue wall by at least a predetermined threshold.

[0089] Example 3 The method of example 1, wherein the portion is identified as being further displaced from the tissue wall than other portions of the distal end assembly.

[0090] Example 4 The method of example 1, wherein the representation is calculated in three dimensions.

[0091] Example 5 2. The method of claim 1, wherein the electrical information is impedance.

[0092] Example 6 The method of example 1, wherein the catheter is a basket-type catheter having a plurality of splines on which the electrodes are disposed, and wherein transforming the representation includes distorting at least one spline from the plurality of splines.

[0093] Example 7 2. The method of example 1, wherein the catheter is a balloon catheter and deforming the indicia comprises contracting or narrowing at least a portion of the balloon catheter.

[0094] Example 8 2. The method of example 1, wherein the modifying of the display is performed under the condition that the catheter is moving within the heart.

[0095] Example 9 2. The method of example 1, wherein visualization of the distal end assembly is rendered without distortion during ablation of the patient's tissue.

[0096] Example 10 2. The method of example 1, wherein the transforming of the display is contingent on a user selection.

[0097] Example 11 2. The method of example 1, further comprising tracking the position and orientation of the distal end assembly.

[0098] Example 12 The method of example 1, further comprising generating a map of the heart chamber based on the position of the distal end assembly within the heart chamber, wherein the visualization of the distal end assembly as deformed is rendered on the map at the current position of the distal end assembly.

[0099] Example 13 13. The method of example 12, wherein the tracking is performed using magnetic position tracking.

[0100] Example 14 2. The method of example 1, wherein the catheter further comprises determining a direction to be steered and rendering a visual indication of the direction proximate the visual display of the distal tip assembly.

[0101] Example 15 2. The method of example 1, further comprising rendering an estimated contour of the tissue wall proximate the distal end assembly.

[0102] Example 16 16. The method of example 15, wherein the contour is estimated based on the distance of each electrode from the tissue wall.

[0103] Example 17 1. A computerized apparatus having a processor coupled to a memory unit, the processor comprising: acquiring electrical information from a plurality of electrodes disposed on a distal end assembly of a catheter within a patient's heart as the catheter is manipulated within the heart; dynamically identifying a portion of the distal tip assembly that is displaced from a tissue wall of the heart based on the electrical information received from the plurality of electrodes; generating a visual representation of the distal tip assembly; dynamically modifying the visual representation by distorting the identified portion of the distal tip assembly; and rendering the visual representation as dynamically transformed on the display device.

[0104] Example 18 The computerized apparatus of example 17, wherein the catheter is a basket-type catheter having a plurality of splines on which the electrodes are disposed, and wherein transforming the display includes distorting at least one spline from the plurality of splines.

[0105] Example 19 18. The computerized apparatus of example 17, wherein the catheter is a balloon catheter and modifying the representation comprises deflating or narrowing at least one portion of the balloon catheter.

[0106] Example 20 1. A computer program product comprising a non-transitory computer-readable medium bearing program instructions that, when read by a processor, cause the processor to: acquiring electrical information from a plurality of electrodes disposed on a distal end assembly of a catheter within a patient's heart as the catheter is manipulated within the heart; dynamically identifying a portion of the distal tip assembly that is displaced from a tissue wall of the heart based on the electrical information received from the plurality of electrodes; generating a visual representation of the distal tip assembly; dynamically modifying the visual representation by distorting the identified portion of the distal tip assembly; A computer program product comprising a non-transitory computer-readable medium bearing program instructions that cause the display device to render the visual display as dynamically transformed.

[0107] Although the embodiments described herein primarily address cardiac diagnostic applications, the methods and systems described herein may also be used in other medical applications.

[0108] It will be understood that the above-described embodiments are given by way of example, and that the present disclosure is not limited to what is particularly shown and described hereinabove. Rather, the scope of the present disclosure includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof not disclosed in the prior art that would occur to one skilled in the art upon reading the foregoing description.

[0109] [Embodiment] (1) A method comprising: acquiring electrical information from a plurality of electrodes disposed on a distal end assembly of a catheter within a patient's heart as the catheter is manipulated within the heart; dynamically identifying a portion of the distal tip assembly that is displaced from a tissue wall of the heart based on the electrical information received from the plurality of electrodes; generating a visual representation of the distal tip assembly; dynamically modifying the visual representation by distorting the identified portion of the distal tip assembly; and and rendering the visual representation as dynamically transformed on a display device. (2) The method of embodiment 1, wherein the portion is identified as being displaced from the tissue wall by at least a predetermined threshold. (3) The method of claim 1, wherein the portion is identified as being further displaced from the tissue wall than other portions of the distal end assembly. (4) The method of claim 1, wherein the representation is calculated in three dimensions. (5) The method of embodiment 1, wherein the electrical information is impedance.

[0110] (6) The method of embodiment 1, wherein the catheter is a basket-type catheter having a plurality of splines on which the electrodes are arranged, and wherein transforming the display includes distorting at least one spline from the plurality of splines. (7) The method of embodiment 1, wherein the catheter is a balloon-type catheter and deforming the display includes contracting or narrowing at least one portion of the balloon-type catheter. (8) The method of embodiment 1, wherein the deforming of the display is performed on the condition that the catheter is moving within the heart. (9) The method of embodiment 1, wherein the visualization of the distal end assembly is rendered without distortion during ablation of the patient's tissue. (10) The method of embodiment 1, wherein transforming the display is conditioned on user selection.

[0111] (11) The method of claim 1, further comprising tracking the position and orientation of the distal end assembly. (12) The method of embodiment 1, further comprising generating a map of the heart chamber based on the position of the distal end assembly within the heart chamber, wherein the visualization of the distal end assembly as deformed is rendered on the map at the current position of the distal end assembly. (13) The method of embodiment 12, wherein the tracking is performed using magnetic position tracking. (14) The method of embodiment 1, further comprising determining a direction in which the catheter is steered and rendering a visual indication of the direction proximate the visual display of the distal tip assembly. (15) The method of embodiment 1, further comprising rendering an estimated contour of the tissue wall near the distal end assembly.

[0112] (16) The method of embodiment 15, wherein the contour is estimated based on the distance of each electrode from the tissue wall. (17) A computerized device having a processor coupled to a memory unit, the processor: acquiring electrical information from a plurality of electrodes disposed on a distal end assembly of a catheter within a patient's heart as the catheter is manipulated within the heart; dynamically identifying a portion of the distal tip assembly that is displaced from a tissue wall of the heart based on the electrical information received from the plurality of electrodes; generating a visual representation of the distal tip assembly; dynamically modifying the visual representation by distorting the identified portion of the distal tip assembly; and rendering the visual representation as dynamically transformed on a display device. (18) The device described in embodiment 17, wherein the catheter is a basket-type catheter having a plurality of splines on which the electrodes are arranged, and wherein transforming the display includes distorting at least one spline from the plurality of splines. (19) The device of embodiment 17, wherein the catheter is a balloon catheter and deforming the display comprises contracting or narrowing at least one portion of the balloon catheter. (20) A computer program product comprising a non-transitory computer-readable storage medium bearing program instructions configured to cause a processor to perform an operation, the program instructions comprising: acquiring electrical information from a plurality of electrodes disposed on a distal end assembly of a catheter within a patient's heart as the catheter is manipulated within the heart; dynamically identifying a portion of the distal tip assembly that is displaced from a tissue wall of the heart based on the electrical information received from the plurality of electrodes; generating a visual representation of the distal tip assembly; dynamically modifying the visual representation by distorting the identified portion of the distal tip assembly; and and rendering the visual representation as dynamically transformed on a display device.

Claims

1. 1. A computerized apparatus having a processor coupled to a memory unit, the processor comprising: acquiring electrical information from a plurality of electrodes disposed on a distal end assembly of a catheter within a patient's heart as the catheter is manipulated within the heart; dynamically identifying a portion of the distal tip assembly that is displaced from a tissue wall of the heart based on the electrical information received from the plurality of electrodes; generating a visual representation of the distal tip assembly; dynamically modifying the visual representation by distorting the identified portion of the distal tip assembly; and rendering the visual representation as dynamically transformed on a display device.

2. 2. The apparatus of claim 1, wherein the catheter is a basket-type catheter having a plurality of splines on which the electrodes are disposed, and wherein transforming the display includes distorting at least one spline from the plurality of splines.

3. 10. The apparatus of claim 1, wherein the catheter is a balloon catheter and modifying the display comprises deflating or narrowing at least one portion of the balloon catheter.

4. 1. A computer program product comprising a non-transitory computer-readable storage medium bearing program instructions configured to cause a processor to perform operations, the program instructions comprising: acquiring electrical information from a plurality of electrodes disposed on a distal end assembly of a catheter within a patient's heart as the catheter is manipulated within the heart; dynamically identifying a portion of the distal tip assembly that is displaced from a tissue wall of the heart based on the electrical information received from the plurality of electrodes; generating a visual representation of the distal tip assembly; dynamically modifying the visual representation by distorting the identified portion of the distal tip assembly; and and rendering the visual representation as dynamically transformed on a display device.

5. 1. A method comprising: acquiring electrical information from a plurality of electrodes disposed on a distal end assembly of a catheter within a patient's heart as the catheter is manipulated within the heart; dynamically identifying a portion of the distal tip assembly that is displaced from a tissue wall of the heart based on the electrical information received from the plurality of electrodes; generating a visual representation of the distal tip assembly; dynamically modifying the visual representation by distorting the identified portion of the distal tip assembly; and and rendering the visual representation as dynamically transformed on a display device.

6. The method of claim 5 , wherein the portion is identified as being displaced from the tissue wall by at least a predetermined threshold.

7. The method of claim 5 , wherein the portion is identified as being further displaced from the tissue wall than other portions of the distal end assembly.

8. The method of claim 5 , wherein the representation is calculated in three dimensions.

9. The method of claim 5 , wherein the electrical information is impedance.

10. 6. The method of claim 5, wherein the catheter is a basket-type catheter having a plurality of splines on which the electrodes are disposed, and wherein distorting the representation includes distorting at least one spline from the plurality of splines.

11. 6. The method of claim 5, wherein the catheter is a balloon catheter and modifying the representation comprises deflating or narrowing at least one portion of the balloon catheter.

12. The method of claim 5 , wherein the modifying of the display is performed conditional on the catheter being in motion within the heart.

13. The method of claim 5 , wherein the visualization of the distal tip assembly is rendered without distortion during ablation of the patient's tissue.

14. The method of claim 5 , wherein transforming the display is conditioned on a user selection.

15. The method of claim 5 , further comprising tracking the position and orientation of the distal tip assembly.

16. 6. The method of claim 5, further comprising generating a map of the heart chamber based on a position of the distal end assembly within the heart chamber, wherein the visualization of the distal end assembly as deformed is rendered on the map at a current position of the distal end assembly.

17. The method of claim 16 , wherein the tracking is performed using magnetic position tracking.

18. The method of claim 5 , further comprising determining a direction in which the catheter is steered and rendering a visual indication of the direction proximate the visual display of the distal tip assembly.

19. The method of claim 5 , further comprising rendering an estimated contour of the tissue wall proximate the distal end assembly.

20. The method of claim 19 , wherein the contour is estimated based on the distance of each electrode from the tissue wall.

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