Devices, systems, and methods for arrhythmia mapping using a multi-electrode mapping catheter system

Abstract

Methods and systems are disclosed for mapping electrophysiological signals in a heart using a catheter having an ultra-high density electrode array. The disclosed technology can include a method comprising: navigating a medical probe to a target location in a heart of a patient; receiving electrophysiological signals from at least some of the electrodes of the plurality of electrodes; identifying an earliest activation point identified as having an earliest activation time based on the electrophysiological signals and the location signals; identifying a plurality of points proximate to the earliest activation point having activation times less than a predetermined duration from the earliest activation time based on the electrophysiological signals and the location signals; and generating an electroanatomical map of the heart representing a location of the earliest activation point for subsequent ablation based on data corresponding to the plurality of points.

Description

Cross-references to related applications

[0001] This application relates to U.S. Patent Application Serial No. 16 / 723,971 (Attorney's File No. BIO6160USNP1), filed December 20, 2019; U.S. Patent Application Serial No. 17 / 489,895 (Attorney's File No. BIO6160USCIP1 (253757.000100)), filed September 30, 2021; and U.S. Patent Application Serial No. 18 / 159, filed January 25, 2023. The entire contents and substantive contents of each of the following patent applications are incorporated herein by reference, as if fully set forth herein: Patent Application No. 288 (Attorney’s File No. BIO6160USCIP2 (253757.000343)) and U.S. Patent Application Serial No. 18 / 969,596 (Attorney’s File No. BIO6944USNP1 (253757.000561) filed on December 5, 2024. Technical Field

[0002] This disclosure relates to apparatus and methods for mapping cardiac structures and identifying locations for ablation of cardiac tissue using a catheter with high-density electrodes. Background Technology

[0003] Compared to conventional systems, advancements in high-density diagnostic catheters and mapping systems have contributed to significantly more efficient procedures and improved ablation outcomes. In the ablation of complex arrhythmias, high-density mapping enhances visualization of areas of slow conduction (critical isthmus) or macroreentrant circuits. Furthermore, rapid electrogram acquisition with higher density and improved resolution has resulted in shorter mapping and procedure times. In atrial fibrillation ablation procedures, high-density mapping has the potential to visualize previously hidden gaps or dormant conduction areas, thereby improving pulmonary vein isolation (PVI) durability and reducing the need for reablation.

[0004] However, in practice, current high-density mapping systems are associated with certain limitations. Interference from far-field signals or noise can lead to poor signal fidelity. In complex atrial matrices with multiple atrial potential components, unipolar electrograms referenced to Wilson central terminals are often timed to the wrong component due to large and steep far-field potentials; this may require manual review and annotation correction. Other limitations include electrode spacing and size that affect the integration of ablation and intracardiac echocardiography.

[0005] Current multi-electrode catheters with a limited number of electrodes, loop electrodes, or fixed-shape catheters are capable of identifying potential target sites; however, increasing the number and type of electrodes in spherical high-density catheters can allow for reductions in mapping and procedure time in clinical settings. The systems and methods disclosed herein aim to improve the resolution and clarity of electrical signal mapping for electrophysiological procedures. Summary of the Invention

[0006] The disclosed technology includes a method of navigating a medical probe to a target location within a patient's heart. The medical probe may extend along a longitudinal axis and includes a plurality of ridges configured to curve radially outward from the longitudinal axis. The plurality of ridges may include a plurality of electrodes disposed thereon and at least one position sensor disposed on the longitudinal axis. The position sensor may be configured to provide a position signal indicating the location of the sensor and the medical probe within the heart.

[0007] The method may further include: receiving electrophysiological signals from at least some of the electrodes among the plurality of electrodes; and identifying an earliest activation point identified as having the earliest activation time based on the electrophysiological signals and the location signal. The method may further include identifying a plurality of points closest to the earliest activation point based on the electrophysiological signals and the location signal, the plurality of points having an activation time less than a predetermined duration starting from the earliest activation time. The method may include generating an electroanatomical mapping of the heart based on data corresponding to the plurality of points. The electroanatomical mapping may indicate the location of the earliest activation point for subsequent ablation.

[0008] The disclosed technology may also include a medical system comprising a medical probe. The medical probe may include: a shaft extending along a longitudinal axis; a plurality of ridges disposed at distal ends of the shaft and configured to bend radially outward from the longitudinal axis to define a cavity between the ridges; and a position sensor disposed on the longitudinal axis. The position sensor may be configured to provide a position signal indicating the position of the sensor and the medical probe within the heart. The medical probe may further include a plurality of electrodes disposed along the ridges and a reference electrode disposed within the cavity.

[0009] The medical system may further include one or more processors and a memory storing instructions that, when executed by the one or more processors, are configured to cause the medical system to receive electrophysiological signals from at least some of the electrodes among the plurality of electrodes. The instructions may also cause the medical system to identify an earliest activation point identified as having the earliest activation time based on the electrophysiological signal and the location signal; identify a plurality of points closest to the earliest activation point, the plurality of points having an activation time less than a predetermined duration starting from the earliest activation time, based on the electrophysiological signal and the location signal; and generate an electroanatomical mapping of the heart based on data corresponding to the plurality of points. The electroanatomical mapping may represent the location of the earliest activation point for subsequent ablation.

[0010] To achieve the foregoing and related objectives, certain exemplary aspects have been described herein in conjunction with the following description and accompanying drawings. However, these aspects indicate only a few of the various ways in which the principles of the claimed subject matter can be employed, and the claimed subject matter is intended to encompass all such aspects and their equivalents. Other advantages and novel features will become apparent from the following detailed description when considered in conjunction with the accompanying drawings. Attached Figure Description

[0011] The foregoing and other aspects of the invention will be further discussed with reference to the following description and the accompanying drawings, in which similar numbers indicate similar structural elements and features in various figures. The drawings are not necessarily drawn to scale; rather, the focus is on illustrating the principles of the invention. The drawings depict one or more specific embodiments of the apparatus of the invention by way of example only and not by way of limitation.

[0012] This patent or application document contains at least one drawing in color. Upon request and payment of the necessary fees, the U.S. Patent and Trademark Office will provide a color-printed copy of this patent or application disclosure.

[0013] Figure 1A An example of a catheter-based electrophysiological mapping and ablation system according to the subject matter disclosed in this invention is illustrated;

[0014] Figure 1B It is constructed and operated according to an example of the present invention. Figure 1A A perspective view of the basket-shaped ducts;

[0015] Figure 2 and Figure 3 yes Figure 1A and Figure 1B A more detailed view of the expandable components of the basket-shaped conduit;

[0016] Figure 4 yes Figure 1A and Figure 1B A partial exploded view of the basket-shaped ducts;

[0017] Figure 5 yes Figure 1A and Figure 1B Enlarged view of the nasal segment of the basket duct, with the nasal cap removed;

[0018] Figure 6A and Figure 6B It is in both extended and collapsed forms. Figure 1A and Figure 1B A schematic diagram of the expandable components of the basket-shaped conduit;

[0019] Figure 7 It is used for Figure 1A and Figure 1B A schematic diagram of a flexible polymer circuit strip in a basket-shaped conduit;

[0020] Figure 8A It is along Figure 7 A sectional view taken by line AA;

[0021] Figures 8B to 8I Examples are shown in Figure 7 Example holes formed in the cover of the flexible polymer circuit strip;

[0022] Figure 8J This is an example in Figure 7 A table of impedance values ​​for example aperture patterns formed in the cover of flexible polymer circuit strips;

[0023] Figure 9 yes Figure 1A and Figure 1B A schematic diagram of the deflectable element of the basket-shaped conduit;

[0024] Figure 10 yes Figure 1A and Figure 1B A schematic diagram of the flushing sleeve of the basket-shaped conduit;

[0025] Figure 11 yes Figure 1A and Figure 1B A schematic diagram of the push rod of the basket-shaped conduit;

[0026] Figure 12 yes Figure 1A and Figure 1B A schematic diagram of a multi-axis position sensor for a basket-shaped conduit;

[0027] Figures 13A to 13B yes Figure 1A and Figure 1B A schematic diagram of the nasal connector of the basket-shaped duct;

[0028] Figure 14 yes Figure 1A and Figure 1B A schematic diagram of the nasal connector retainer of the basket-shaped duct;

[0029] Figures 15A to 15B yes Figure 1A and Figure 1B A schematic diagram of the nasal cap of a basket-shaped duct;

[0030] Figure 16 yes Figure 1A and Figure 1B A schematic diagram of the connector for the basket-shaped conduit;

[0031] Figure 17 yes Figure 1A and Figure 1B A schematic diagram of a uniaxial position sensor for a basket-shaped conduit;

[0032] Figure 18 yes Figure 1A and Figure 1B A schematic diagram of the proximal retainer ring of the basket-shaped duct;

[0033] Figures 19 to 20 It is along Figure 1B A sectional view taken by line AA;

[0034] Figure 21 Another view of a basket-shaped conduit according to an example of the invention is shown, wherein the annotations illustrate various features of the conduit;

[0035] Figure 22 An example view of a basket-shaped conduit, as rendered on a display, according to the invention, is shown, illustrating the basket in both an expanded and collapsed state.

[0036] Figure 23A and Figure 23B Examples of patient inclusion and exclusion criteria as part of catheter studies according to the present invention are illustrated;

[0037] Figure 24 This is a table illustrating the baseline demographics and comorbidities of participants registered in the study, according to an example of the invention;

[0038] Figure 25A and Figure 25B This is a table showing the atrial and ventricular arrhythmias and ablation surgery history of participants in the study, according to an example of the present invention;

[0039] Figure 26 This is a table of surgical features of an operation performed as part of a study according to an example of the present invention;

[0040] Figures 27A to 27D A graphical representation of left atrial atypical flutter timing (LAT) and voltage (bipolar) mapping of a patient's heart using a catheter, according to an example of the present invention;

[0041] Figure 28A and Figure 28B An example of an electrocardiogram recording of a patient's heart observed via catheter according to the invention;

[0042] Figure 29 A graphical representation of a catheter positioned in a patient's heart to perform a mapping procedure, according to an example of the invention;

[0043] Figure 30 A graphical representation of a catheter located in a patient's heart according to an example of the invention is shown, illustrating the site of focal atrial tachycardia before the QS P wave mapped and identified in the left anterior carina region.

[0044] Figure 31 This is a summary table of regions of interest identified using catheters in participants with atrial tachycardia according to an example of the invention, the regions of interest including PVI triggering, PVI penetration, non-PV AF lesions, critical isthmus of the left atrium, and Cavo tricuspid isthmus;

[0045] Figure 32 An example of a PVC mapping according to the invention is shown, showing the earliest pre-QRS site identified using a catheter at the RVOT in the septum.

[0046] Figure 33 The area and perimeter of the earliest activation timing location are illustrated in the example according to the invention and compared with a reference to the mapping diagram;

[0047] Figure 34 This is a summary table of all PVC cases that identify the earliest point based on the intermediate QRS (reference), the QRS before the earliest point, the area of ​​the earliest activation point, and the perimeter of the earliest activation point, according to an example of the present invention.

[0048] Figure 35 A flowchart illustrating a method of using a catheter according to an example of the present invention is shown; and

[0049] Figure 36 A schematic diagram illustrating a method of using a catheter according to an example of the present invention is shown. Detailed Implementation

[0050] The disclosed techniques include a catheter having multiple ridges and high-density electrodes disposed along the ridges. As will become apparent throughout this disclosure, the disclosed systems and methods can be used to create more accurate electroanatomical mappings of a patient's heart. Furthermore, the disclosed techniques can help to accurately identify sites within the heart to be ablated, thereby reducing or eliminating abnormal electrical signals in the heart. Specifically, the disclosed techniques include identifying the location of the earliest activation time in the heart and multiple points closest to the earliest activation point, these multiple points having an activation time less than a predetermined duration (e.g., less than one second, less than 10 milliseconds, less than 1 millisecond) from the earliest activation time. In this way, an electroanatomical mapping of the patient's heart identifying the sites to be ablated can be generated.

[0051] Although this document explains in detail exemplary embodiments of the disclosed technology, it should be understood that other embodiments are conceivable. Therefore, it is not intended to limit the scope of the disclosed technology to the details of the construction and arrangement of the components set forth in the following description or shown in the accompanying drawings. The disclosed technology is capable of having other embodiments and can be practiced or implemented in various ways.

[0052] It should also be noted that, unless the context clearly indicates otherwise, the singular forms “a” and “the” used in this specification and the appended claims include plural references. The terms “comprising,” “containing,” or “including” mean that at least the named compound, element, particle, or method step is present in the composition, article, or method, but do not exclude the presence of other compounds, materials, particles, or method steps, even if such other compounds, materials, particles, or method steps have the same function as those named.

[0053] As used herein, the term “about” or “approximately” for any numerical value or range indicates appropriate dimensional tolerances that allow a collection of parts or components to achieve the intended purpose as described herein. More specifically, “about” or “approximately” may refer to a range of ±20% of the enumerated values, for example, “about 90%” may refer to a range of values ​​from 71% to 99%.

[0054] As discussed in this article, the heart or vascular system of the “subject” or “patient” can be that of a human or any animal. The term “proximal” means the object is closer to the physician, and “distal” means the object is further away from the physician.

[0055] As used in the context of circuit strips herein, the term "longitudinal" refers to the direction along the length of the strip from the proximal end to the distal end. The term "lateral" refers to the direction perpendicular to the longitudinal axis, spanning the width of the strip. The term "thickness" refers to the dimension perpendicular to both the longitudinal and lateral directions, indicating the depth of the strip from the top surface (i.e., the top layer) to the bottom surface (the bottom layer).

[0056] In the following detailed description, numerous specific details are set forth in order to provide a comprehensive understanding. However, those skilled in the art will understand that the subject matter disclosed herein can be practiced without these specific details. In other instances, well-known methods and features have not been described in detail so as not to obscure the subject matter disclosed herein.

[0057] In describing example embodiments, terminology will be used for clarity. It is intended that each term be contemplated for its broadest meaning as understood by one skilled in the art, and includes all technical equivalents that operate in a similar manner to achieve similar purposes. It should also be understood that reference to one or more steps of a method does not exclude the presence of additional method steps or intermediate method steps between those explicitly identified steps. The steps of a method may be performed in a different order than that described herein without departing from the scope of the disclosed art. Similarly, it should be understood that reference to one or more components in an apparatus or system does not exclude the presence of additional components or intermediate components between those explicitly identified components.

[0058] System Description

[0059] refer to Figure 1A The figure illustrates an example catheter-based electrophysiological mapping and ablation system 100. System 100 includes multiple catheters inserted by a physician 5 through the skin into the chambers or vascular structures of the heart 112 within the patient's vascular system. Typically, a delivery sheath catheter is inserted into the left or right atrium near a desired location within the heart 112. One or more catheters can then be inserted into the delivery sheath catheter to reach the desired location within the heart 112. These 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. Figure 1A The illustrations illustrate an example catheter 10 configured for ablation of tissue and / or for sensing and / or mapping of electrical activity.

[0060] The catheter 10 is an exemplary catheter having an end effector at its distal end, the end effector including an expandable component 22 having one and preferably multiple electrodes 26 optionally distributed on a plurality of flexible ridge elements 24 (sometimes referred to herein as “flexible polymer circuit strips 24”). The electrodes 26 are typically configured to deliver ablation energy to tissue and / or to sense cardiac electrical signals (e.g., IEGG signals). The catheter 10 additionally includes one or more position sensors 74 embedded in or near the distal end for tracking the positioning and orientation of the distal end. Optionally and preferably, the position sensors 74 are magnetically based position sensors, such as a position sensor including three magnetic coils for sensing three-dimensional (3D) position and orientation; or a position sensor including a single magnetic coil for sensing a single orientation. In some examples, the catheter 10 may include a first position sensor 74 disposed near the proximal end of the expandable component 22 and a second position sensor 74 disposed near the distal end of the expandable component. In this way, the positions of the first and second position sensors 74 can be used to determine the elongated state and shape of the expandable component 22. This can be used to determine when the expandable component 22 is ready to retract into the sheath and when the expandable component is fully deployed for mapping and / or ablation.

[0061] Each position sensor in the magnetic-based position sensor 74 operates in conjunction with a position pad 125, which includes a plurality of magnetic coils 132 configured to generate a magnetic field in a predefined workspace. The real-time position of the distal end of the conduit 10 can be tracked based on the magnetic field generated by the position pad 125 and sensed by the magnetic-based position sensor 74. Details of the magnetic-based position sensing technology are described in U.S. Patents Nos. 5,391,199, 5,443,489, 5,558,091, 6,172,499, 6,239,724, 6,332,089, 6,484,118, 6,618,612, 6,690,963, 6,788,967, and 6,892,091, the entire contents of each of which are incorporated herein by reference.

[0062] Physician 5 can position the distal end of catheter 10 in contact with the heart wall to sense a target site in the heart 112. Similarly, for ablation, physician 5 can position the distal end of ablation catheter in contact with the target site to ablate tissue.

[0063] System 100 includes one or more electrode patches 138 positioned to contact the skin of patient 23 to establish a position reference for impedance-based tracking of positioning pad 125 and electrodes 26. For impedance-based tracking, current is directed to electrodes 26 and sensed at the electrode skin patch 138, allowing triangulation of the position of each electrode via the electrode patch 138. Details of the impedance-based position tracking technique are described in U.S. Patents 7,536,218, 7,756,576, 7,848,787, 7,869,865, and 8,456,182, the entire contents of each of which are incorporated herein by reference.

[0064] Recorder 111 records and displays an electrocardiogram 121 captured using surface ECG electrodes 118 and an intracardiac electrocardiogram (IEGM) captured using electrodes 26 of catheter 10. Recorder 111 may include pacing capability for pacing rhythms and / or may be electrically connected to a separate pacemaker.

[0065] System 100 may include an ablation energy generator 150 adapted to conduct ablation energy to one or more electrodes at the distal end of a catheter configured for ablation. The energy generated by the ablation energy generator 150 may include, but is not limited to, radio frequency (RF) energy or pulsed field ablation (PFA) energy (including monopolar or bipolar high-voltage DC pulses that can be used to achieve irreversible electroporation (IRE), or combinations thereof.

[0066] The patient interface unit (PIU) 130 is configured to establish electrical communication between catheters, other electrophysiological equipment, a power supply, and a workstation 155 for operating the control system 100. The electrophysiological equipment of the system 100 may include, for example, multiple catheters, a positioning pad 125, surface ECG electrodes 118, electrode patches 138, an ablation energy generator 150, and a recorder 111. Optionally and preferably, the PIU 130 further has processing capabilities for real-time calculation of catheter position and for performing ECG calculations.

[0067] Workstation 155 includes a memory, a processor unit having a memory or storage device in which appropriate operating software is stored, and user interaction capabilities. Workstation 155 may provide several functions, optionally including: (1) three-dimensional (3D) modeling of the endocardial anatomy and rendering the model or anatomical mapping 120 for display on display device 127; (2) displaying on display device 127 a sequence of activations (or other data) compiled from the recorded electrophysiological mapping 121 by means of representative visual markers or images superimposed on the rendered anatomical mapping 120; (3) displaying the real-time position and orientation of multiple catheters within the cardiac cavity; and (4) displaying on display device 127 sites of interest, such as where ablation energy has been applied or will be applied. A commercial product embodying the elements of system 100 may be CARTO. ® 3 System was purchased from BiosenseWebster, Inc., 31 Technology Drive, Suite 200, Irvine, CA 92618.

[0068] In some examples, the study catheter is associated with CARTO. ® 3. An EP navigation system is used in conjunction with a multi-electrode ECG mapping catheter. This research catheter is designed for deployment within the cardiac chamber via an 8.5F guide sheath. In some examples, and as will be described in more detail herein, the bidirectional deflectable catheter may include ten basket-shaped ridges at its deflectable tip, each ridge having ten coated electrodes for stimulation and recording. Additionally, catheter 10 may include two position sensors 74 located along the longitudinal axis near the distal end of catheter 10.

[0069] In some examples, a flushing module is provided for delivering flushing fluid, such as a saline solution, to the treatment site. The flushing module may include a pump and an associated fluid tank.

[0070] Description of catheter

[0071] Overview

[0072] The deflectable bidirectional mapping catheter described in this paper is designed with one hundred electrodes coated on 10 ridges to form a basket shape. It features an 8Fr shaft compatible with an 8.5Fr sheath for advancement into the cardiac chamber. The baskets are adaptable in size, ranging from a minimum of 3 mm to a maximum of 18 mm in diameter, and can acquire mapping maps throughout the deployment range as needed at specific anatomical locations. The basket array consists of 10 nitinol ridges with laminated flexible printed circuitry, each ridge bearing 10 tiny outward-facing gold electrodes (0.5 mm² surface area and 1.7 mm inter-electrode spacing, center-to-center) (totaling 100 electrodes), which connect proximally to a flat nasal tip. The electrodes are flat and have an impedance-reducing coating to allow for lower impedance, improved signal quality, and a superior signal-to-noise ratio compared to previous high-density mapping catheters.

[0073] Three magnetic sensors (two in the distal portion and one in the proximal portion) are embedded in a basket array that transmits position and angle information, independent of the higher-level conduit location, to CARTO with a system accuracy of <1 mm. ® 3System (Biosense Webster, Inc.). Two electrodes are located beneath the ridge on the deflectable end, allowing for [the application of CARTO]. ® Visualization of the axes on the 3-system. The TRUEref Electrode (Biosense Webster, Inc.) embedded in the center of the sphere can be used as a non-contact central reference electrode or a tight unipolar reference electrode within the cardiac cavity, allowing for enhanced qualitative and filtering of the incoming signal for mapping annotation. CARTO ® Software version 7 is compatible with reducing the need for manual annotation; added features include automatic outlier detection and a point binning algorithm known as "WofC" (Swarm Intelligence). As will be described in more detail in this paper, this feature is based on 1mm... 3 Specific standards collected within a predefined Fast Anatomical Mapping (FAM) region (voxel) are used to remove outliers at timing or voltage annotations.

[0074] Detailed description of the catheter

[0075] Now for reference Figure 1BThis figure is a schematic diagram of a basket-shaped conduit 10 constructed and operated according to an embodiment of the present invention. The basket-shaped conduit 10 includes an elongated deflectable element 12 having a distal end 14, a connector 16 connected to the distal end 14, and a push rod 18 including a distal portion 20. The push rod 18 is configured to be advanced and retracted through the deflectable element 12, for example using a manipulator or handle (not shown). The basket-shaped conduit 10 also includes an expandable assembly 22 comprising a plurality of flexible polymer circuit strips 24 (sometimes referred to herein as “ridges,” but only a few are labeled for simplicity). Each flexible polymer circuit strip 24 includes a plurality of electrodes 26 disposed thereon (only a few are labeled for simplicity). Reference Figures 4 to 20 It describes in more detail the formation of the various components and how they are connected to each other.

[0076] Now for reference Figure 2 and Figure 3 These pictures are Figure 1A and Figure 1B Detailed view of the expandable component 22 of the basket-shaped conduit 10. Figure 2 and Figure 3 The electrodes 26 on the flexible polymer circuit strip 24 are shown more clearly. Figure 2 The electrodes 26 are shown not positioned on the proximal portion of the flexible polymer circuit strip 24, but in some examples these electrodes may be positioned on the proximal portion. The basket-shaped conduit 10 includes a nasal connector 30 connected to the distal portion 20 of the push rod 18. The flexible polymer circuit strip 24 is connected to the nasal connector 30 via hinges 28 (some are labeled for simplicity) of the flexible polymer circuit strip 24.

[0077] Now for reference Figures 4 to 5 . Figure 4 yes Figure 1A and Figure 1B A partial exploded view of the basket-shaped duct 10. Figure 5 yes Figure 1A and Figure 1B Enlarged view of the nasal segment of the basket-shaped duct 10, with the nasal cap 32 removed.

[0078] Figure 4 The nose cap 32 and connector 16, removed from the basket-shaped conduit 10, are shown to illustrate how the flexible polymer circuit strip 24 is connected to the nose connector 30 and connector 16. The nose connector 30 is connected to the distal portion 20 of the push rod 18. The proximal end of the connector 16 can be connected to the elongated deflectable element 12 using any suitable connection method, such as the use of an adhesive, e.g., epoxy resin. The nose connector 30 is secured to the distal portion 20 of the push rod 18 using a center electrode ring 40, which references... Figure 14 and Figure 19To describe in more detail. A flexible polymer circuit strip 24 is circumferentially arranged around the distal portion 20 of the push rod 18, wherein a first end 42 of the strip 24 (only some are labeled for simplicity) is connected to the inner surface 44 of the connector 16. Reference Figure 20 The connection between the flexible polymer circuit strip 24 and the inner surface 44 is shown more clearly.

[0079] like Figures 2 to 4 As shown, the catheter may also include a reference electrode 31, which may be mounted in the middle of the expandable assembly along a longitudinal axis extending through the center of the expandable assembly 22. The reference electrode 31 may be configured to detect electrophysiological signals propagating through blood or other fluids and to reduce noise detected by electrode 26. It will be understood that the electrophysiological signal detected by the reference electrode 31 may be compared with, or subtracted from, the electrophysiological signal detected by the reference electrode from the electrophysiological signal detected by the electrode 26 in contact with the tissue, to reduce or eliminate far-field noise, thereby achieving a more accurate readout of the electrophysiological signals propagating through the tissue.

[0080] The disclosed technique can be configured to measure electrophysiological signals at electrodes 26 on the ridge 24, at more than one electrode 26 on the ridge, and / or at a reference electrode 31 to obtain accurate electrophysiological signals. For example, a monopolar measurement can be performed between the electrode 26 on the ridge 24 and the reference electrode 31 to eliminate far-field noise. Furthermore, a bipolar measurement can be performed between two or more electrodes 26 on the ridge 24 to determine the electrophysiological signal at each electrode 26 and to determine the electrophysiological signal between predetermined electrodes 26. For example, a bipolar measurement can be achieved between a first electrode 26 on the ridge 24 and a second electrode 26 on the same ridge 24. Alternatively, a bipolar measurement can be achieved between a first electrode 26 on a first ridge 24 and a second electrode 26 on a second ridge 24. It will be understood that the disclosed technique can be configured to measure and compare electrophysiological signals between any of the electrodes 26 and / or the reference electrode 31 to achieve highly accurate electrophysiological measurements.

[0081] Furthermore, the disclosed technique can be configured to associate the location of a specific electrode 26 with electrophysiological data obtained from the specific electrode 26. In this way, the disclosed technique can be configured to accurately output location and electrophysiological data to generate a high-density electrophysiological mapping of a patient's heart.

[0082] Figure 5 The nose connector 30 is shown to include a distal jack 34 having an inner surface 36 and a distally facing opening 38. (Reference) Figures 13A to 13B and Figure 19 The nose connector 30 is described in more detail. Figure 5 The diagram shows the corresponding hinge 28 ( Figure 5 The second end 46 of strip 24 () Figure 5 (For simplicity, only some are marked) Entering the far-facing opening 38 ( Figure 5 ) and connected to the distal jack 34 of the nose connector 30 ( Figure 5 ) inner surface 36 ( Figure 5 ).

[0083] Figure 4 The basket-shaped conduit 10 also includes a corresponding elongated resilient support element 48 connected along a given length of a corresponding flexible polymer circuit strip in the flexible polymer circuit strip 24, thereby providing the expandable assembly 22 in an extended form. The elongated resilient support element 48 may form a ridge or may be part of a ridge and may contain any suitable material, such as, but not limited to, nitinol and / or polyetherimide (PEI).

[0084] Figure 4 The corresponding elongated elastic support element 48 is shown extending from the connector 16 along the inner surface of the corresponding strip 24, while Figure 5 An elongated, elastic support element 48 is shown extending along the corresponding flexible polymer circuit strip 24 up to the corresponding hinge 28. Figure 5 Illustration 50 shows a hinge in hinge 28 and a portion of a flexible polymer circuit strip 24 adjacent to hinge 28. Illustration 50 illustrates the area where the elongated elastic support element 48 does not extend into hinge 28. It can also be seen that the hinge region is much thinner than the region including the elongated elastic support element 48. Hinge 28 may have any suitable thickness, for example, in the range of about 10 micrometers to about 140 micrometers. Strip 24 is folded such that strip 24 defines a configuration that is substantially perpendicular to each other (illustration 50).

[0085] In some embodiments, each flexible polymer circuit strip 24 includes a polyimide layer. The flexible polymer circuit strip 24 can be made of any suitable material. (Reference) Figure 7 The flexible polymer circuit strip 24 is described in more detail in Figure 8.

[0086] Figure 5 It is also shown that the corresponding second end 46 of the corresponding flexible polymer circuit strip in the flexible polymer circuit strip 24 tapers along the width of the corresponding flexible polymer circuit strip in the flexible polymer circuit strip 24 to allow the second end 46 to be inserted into the distal socket 34 without overlap. The hinge 28 can be attached to the inner surface 36 of the distal socket 34 using any suitable adhesive (e.g., epoxy resin) and / or using any suitable connection method.

[0087] The hinges 28 of the flexible polymer circuit strip 24 are supported by yarns 52 of a certain length, which typically extend along the length of each respective flexible polymer circuit strip 24. Each flexible polymer circuit strip 24, together with the yarns 52 and the associated elongated elastic support element 48, may be covered with a suitable cover 54, such as referenced in [reference]. Figure 8A A more detailed description of the thermoplastic polymer resin shrink wrap (PET). Yarn 52 can be any suitable high-strength polymer, including, for example, ultra-high molecular weight polyethylene (Spectra or Dyneema), Kevlar, liquid crystal polymer (Vectran), etc.

[0088] Now for reference Figure 6A and Figure 6B These figures are in expanded and collapsed forms, respectively. Figure 1A and Figure 1B A schematic diagram of the expandable assembly 22 of the basket-shaped conduit 10. The flexible polymer circuit strip 24 is configured to bend radially outward when the push rod 18 retracts, thereby expanding the expandable assembly 22 from a collapsed form to an extended form. The collapsed form of the expandable assembly 22 represents the non-stressed form of the flexible polymer circuit strip 24, the shape of which is achieved by using an elongated elastic support element 48 (…). Figure 4 And possesses.

[0089] In some embodiments, the flexible polymer circuit strip 24 is formed as a flat strip, as shown in the reference. Figure 7 A more detailed description is provided. The distal end of the flexible polymer circuit strip 24 is connected to the inner surface 36 of the nose connector 30. Figure 5 At this point, the flat flexible polymer circuit strip 24 is substantially parallel to line 58, which is the distal extension of the axis of the nose connector 30 beyond the distal end of the nose connector 30. The proximal end of the flexible polymer circuit strip 24 is then connected to the connector 16 such that, in the collapsed form, the angle between the tangent 56 and line 58 of the flexible polymer circuit strip 24 is approximately 180 degrees, while in the extended form, the angle between the tangent 56 and line 58 is approximately 90 degrees. Therefore, in operation (when the flexible polymer circuit strip 24 is connected to the nose connector 30 and the connector 16), the hinge 28 is configured to provide a maximum angular range of movement of the flexible polymer circuit strip 24 of approximately 90 degrees and typically exceeding 80 degrees. However, the hinge 28 is capable of bending at angles of 180 degrees or greater. The maximum angular range is defined as the maximum angular range between the tangent 56 and line 58 of the flexible polymer circuit strip 24. The tangent 56 of the farthest portion of the flexible polymer circuit strip 24 typically provides the maximum angular range between the flexible polymer circuit strip 24 and the line 58.

[0090] Now for reference Figure 7 This image is for use Figure 1A and Figure 1B A schematic diagram of a flexible polymer circuit strip 24 in a basket conduit 10. The flexible polymer circuit strip 24 may be formed from a single polymer such as polyimide. The circuit strips 24 can be connected to each other via polyimide, or assembled into individual pieces that maintain proper alignment and are secured to the connector 16. By manufacturing the circuit strips 24 as individual components, the yield of the base circuit can be increased, as a faulty electrode renders a circuit strip unusable rather than the entire strip assembly. A corresponding first end 42 of each flexible polymer circuit strip 24 includes an electrical connection array 60. Illustration 62 shows the electrical connection array 60 including electrical contacts 64 (some are only labeled for simplicity). The electrical contacts 64 are connected via traces (not shown) on the back of the flexible polymer circuit strip 24 to corresponding electrodes in electrodes 26 disposed on the front of the flexible polymer circuit strip 24. Away from the first end 42, the flexible polymer circuit strips 24 are spaced apart to allow the flexible polymer circuit strips 24 to form an expandable assembly 22 when connected to the basket conduit 10. Figure 1A and Figure 1B A wire (not shown) can connect electrode 26 to a control circuit (not shown) via electrical contact 64. The wire can be disposed in an elongated deflectable element 12. Figure 4 ) lumen 66 ( Figure 4 )middle.

[0091] The flexible polymer circuit strip 24 can have any suitable size. For example, the length of the flexible polymer circuit strip 24 can be in the range of 10 mm to 60 mm (e.g., 30 mm), the width of the flexible polymer circuit strip 24 can be in the range of 0.25 mm to 3 mm (e.g., 0.72 mm), and the thickness of the flexible polymer circuit strip 24 can be in the range of 0.005 mm to 0.14 mm.

[0092] Now for reference Figure 8A The image shows the route along... Figure 7A cross-sectional view taken from line AA. Yarn 52 extends along the length of the elongated elastic support element 48 (e.g., formed of nitinol or PEI) and beyond that length, such that yarn 52 also extends along the length of the hinge 28 formed of the flexible polymer circuit strip 24. The elongated elastic support element 48 may have any suitable thickness, for example, in the range of 0.025 mm to 0.25 mm. A cover 68, such as thermoplastic polymer shrink wrap (PET), is placed over the yarn 52 and the elongated elastic support element 48. Epoxy resin is injected into the cover 68. Heat is then applied to the cover, thereby causing the cover over the yarn 52 and the elongated elastic support element 48 to shrink. One reason for covering the elongated elastic support element 48 with cover 68 is to electrically isolate the elongated elastic support element 48 from the circuit traces of the flexible polymer circuit strip 24. For example, if the elongated elastic support element 48 is covered with an insulating coating (e.g., polyurethane) or is made of an insulating material, the cover 68 may be omitted.

[0093] Yarn 52 may include any one or more of the following: ultra-high molecular weight polyethylene yarn; or yarn spun from a liquid crystal polymer. Yarn 52 may have any suitable linear density, for example, in the range of 25 denier and 250 denier.

[0094] A flexible polymer circuit strip 24 is then placed over the yarn 52 and the elongated elastic support element 48, with the circuit traces of the flexible polymer circuit strip 24 facing the elongated elastic support element 48 and the electrodes 26 of the flexible polymer circuit strip 24 facing away from the elongated elastic support element 48. A cover 54 is disposed around the combination of the flexible polymer circuit strip 24, the yarn 52, and the elongated elastic support element 48, and epoxy resin 70 is injected into the cover 54. The cover 54 is then heated, causing the cover 54 to shrink around the combination. Thus, the flexible polymer circuit strip 24 is covered with a cover 54, such as a thermoplastic polymer shrink wrap (PET).

[0095] like Figure 8A As illustrated, holes 55 can be formed through the cover 54 to expose the electrodes 26. In some examples, the holes 55 may expose the entire outer surface of each electrode 26, or the holes may expose only a portion of the outer surface of each electrode 26. The holes 55 can be formed by using a laser to cut or otherwise remove the cover 54 to expose the electrodes 26. In other examples, the holes 55 can be formed by mechanically removing the cover 54, by chemically etching the cover, by plasma etching the cover, or by other suitable methods of removing the cover 54. The cover 54 can be removed such that the conductive surface of each electrode 26 is disposed approximately 12 micrometers below the outer surface of the cover 54. (See also: Regarding...) Figures 8B to 8IIn more detail, if the aperture 55 exposes only a portion of the outer surface of each electrode 26, the aperture 55 may include a plurality of small apertures 55 that collectively define a conductive area less than 50% of the conductive surface of the electrode 26.

[0096] Some or all of the electrodes 26 may also be coated with coating 27 to help ensure that the electrodes 26 can properly detect electrical signals from the heart. Coating 27 can be any type of coating suitable for application. As a non-limiting example, coating 27 may be poly(3,4-ethylenedioxythiophene) (PEDOT), poly(3,4-ethylenedioxythiophene) polystyrene sulfonate (PEDOT:PSS), electrochemically grown iridium oxide, electrochemically grown titanium nitride (TiN), or any other suitable coating for a particular application. Coating 27 can help reduce the overall impedance of the electrodes 26. In some examples, coating 27 may be applied to the exposed surface of the electrodes 26 such that the overall impedance can be reduced by about 99% at low frequencies. As an example, coating 27 may be configured such that the input impedance of each electrode 26 is measured to be less than 13,000 ohms at 1 Hz.

[0097] Coating 27 may be a hydrogel, which may electrochemically grow or adhere to electrode 26 when current passes through it. In other examples, coating 27 may be mechanically applied to each electrode 26 by spraying, smearing, dipping, or otherwise covering the electrode 26 with coating 27. The coating may have a thickness between 10 nanometers and 10 micrometers. In some examples, the thickness of the coating may be less than the thickness of cover 54, such that cover 54 may help protect coating 27 from contact connector 16, deflectable element 12, or other objects that may damage coating 27.

[0098] Now for reference Figures 8B to 8I Its example is in Figure 7 Example hole 55 formed in the cover of the flexible polymer circuit strip. By forming hole 55 through the cover 54 to expose the surface of electrode 26, the exposed surface of electrode 26 can be coated with coating 27. Figures 8B to 8IAs illustrated, the aperture 55 can have many shapes, sizes, and configurations. As one skilled in the art will understand, by changing the shape, size, and configuration of the aperture 55, the amount of exposed surface area of ​​the electrode 26 can be increased or decreased, thereby effectively increasing or decreasing the conductive surface area of ​​the electrode 26. Furthermore, by increasing or decreasing the exposed surface area of ​​the electrode 26, the amount of coating 27 that can be applied to the aperture 55 will also increase or decrease. In other words, as the size of the aperture 55 increases, the surface area of ​​the coating 27 in each aperture 55 also increases, which may cause the coating 27 to be more likely to rub against the object and become delaminated. Therefore, when the size of the aperture 55 decreases, the cover 54 can provide more mechanical protection to the coating 27 to help reduce the likelihood of the coating 27 coming into contact with the object when using the basket conduit 10. However, as will be understood, when the size of a given aperture 55 decreases, the conductive surface area of ​​the electrode 26 will also decrease. Therefore, the size, shape, and configuration of the aperture 55 above the electrode 26 can be optimized to allow the electrode to adequately detect electrical signals while also ensuring that the cover 54 provides sufficient mechanical protection to the coating 27. Manufacturability is another consideration. Currently, it is preferred that the feature portion of the cover 54 is at least 0.003 inches (76 micrometers) to avoid damaging the cover 54 between the holes 55 during manufacturing.

[0099] Figure 8B An example electrode 26 is illustrated having a flexible polymer circuit strip 24 with circular holes 55A passing through a cover 54. In this example, eight circular holes 55A may be formed through the cover 54, with each circular hole 55A being equally spaced from each other. As will be understood, depending on the application, more or fewer circular holes 55A may be formed through the cover 54. Furthermore, in some examples, the circular holes 55A may be unevenly spaced from each other. A coating 27 may adhere to the exposed surface of the electrode 26 within each circular hole 55A.

[0100] In other examples, hole 55 can have a polygonal shape. For example, Figure 8C An electrode 26 of a flexible polymer circuit strip 24 with rectangular holes 55B passing through a cover 54 is illustrated. In this example, fifteen rectangular holes 55B can be formed through the cover 54, wherein each rectangular hole 55B is equally spaced from each other. The rectangular holes 55B can have a square or other rectangular shape. As another example, Figure 8D An electrode 26 is illustrated with a flexible polymer circuit strip 24 having decagonal holes 55C passing through a cover 54. In this example, fifteen decagonal holes 55C can be formed through the cover 54, wherein each decagonal hole 55C is equally spaced from each other. As yet another example, Figure 8EAn electrode 26 with a flexible polymer circuit strip 24 having triangular holes 55D passing through a cover 54 is illustrated. In this example, nineteen triangular holes 55D can be formed through the cover 54. The triangular holes 55D can be offset between each row of triangular holes 55D, such that the first row includes four triangular holes 55D and the second row includes three triangular holes 55D. Furthermore, the alternating rows can be inverted relative to the previous row. This allows the apex of the inverted triangular holes 55D to be partially nested between two other triangular holes 55D in the previous row. A coating 27 can be adhered to the exposed surface of the electrode 26 within each rectangular hole 55B, decagonal hole 55C, triangular hole 55D, etc.

[0101] As those skilled in the art will appreciate, various other shapes and sizes of holes 55 can be formed through the cover 54 to expose the surface of the electrode 26. Furthermore, holes 55 of various shapes can be formed over a single electrode 26 through the cover 54. For example, circular holes 55A, decagonal holes 55C, and triangular holes 55D can be formed together over a single electrode 26. Similarly, holes 55 of one size can be formed over the electrode 26 through the cover 54 together with holes 55 of different sizes. Furthermore, holes 55 can be evenly spaced across the surface of the electrode 26 or unevenly spaced across the surface of the electrode 26.

[0102] Figure 8F and Figure 8G An example electrode 26 is illustrated in a flexible polymer circuit strip 24 having an aperture 55, which is an elongated slit 55E, 55F formed through a cover 54. At least four elongated slits 55E, 55F may be formed through the cover 54 to expose the surface of the electrode 26, but it should be understood that, depending on the application, more or fewer elongated slits 55E, 55F may be formed. Figure 8F In the example illustrated, the elongated slit 55E can extend along its length from near one end of electrode 26 to near a second end of electrode 26. Figure 8G In the example illustrated, the elongated slit 55E may extend in the width direction from near one end of the electrode 26 to near the second end of the electrode 26.

[0103] As those skilled in the art will understand, by forming elongated slits 55E, 55F through the cover 54, a larger continuous surface area of ​​the electrode 26 can be exposed. This can help increase the exposed conductive surface area of ​​the electrode 26, but may also increase the likelihood of friction of the coating 27 during use. Therefore, the spacing and size of the elongated slits 55E, 55F can be varied to help ensure that the electrode 26 has a sufficient amount of exposed surface area while also ensuring that the coating 27 is adequately protected.

[0104] Figure 8HAn example electrode 26 is shown in a flexible polymer circuit strip 24 having a hole 55, which is an elongated slit 55G formed through a cover 54. Figure 8F and Figure 8G Unlike the illustrated elongated slits 55E and 55F, elongated slit 55G extends only a portion of the length of electrode 26 (e.g., approximately less than 1 / 3 of the length of electrode 26). In this way, elongated slit 55G can be configured to provide stronger mechanical protection to coating 27 while still ensuring that a sufficient amount of electrode 26 is exposed.

[0105] Figure 8I An example electrode 26 of a flexible polymer circuit strip 24 is illustrated, having a combination of a circular aperture 55A and an elongated slit 55E. In this example, the elongated slit 55E can help increase the exposed surface area of ​​the electrode 26, while the circular aperture 55A can expose some surface area of ​​the electrode 26, while also helping to provide better mechanical protection to the coating 27. As those skilled in the art will appreciate, any of the example apertures 55A to 55D and the elongated slits 55E to 55G can be combined to help ensure adequate exposure of the electrode 26 while also ensuring proper protection of the coating 27.

[0106] Now for reference Figure 8J The diagram is an example. Figure 7 Table 1 provides a table of impedance values ​​for example patterns of holes 55 formed in the cover of a flexible polymer circuit strip. Although Table 1 illustrates impedance values ​​for several selected patterns of holes 55 obtained experimentally, impedance values ​​for any pattern of holes 55 described herein can also be obtained. Therefore, Table 1 should not be construed as limiting, but is provided to illustrate impedance values ​​for several example patterns of holes 55.

[0107] like Figure 8J The illustration shows the impedance values ​​(in ohms) at frequencies of 1 Hz, 10 Hz, 50 Hz, and 100 Hz for six different hole 55 patterns and two control samples (one control sample has a coating 27 covering approximately 100% of the surface of electrode 26, while the other control sample has no coating 27). As shown, the impedance generally decreases with increasing input frequency. Furthermore, the impedance value is negatively correlated with the exposed surface area. For illustrative purposes, illustrations of the six different hole 55 patterns are shown in Table 1 below.

[0108] Table 1, from left to right, shows the impedance data for a first example electrode 26 (Example 1) having three rows of seven circular holes 55A each. The impedance of Example 1 can range from approximately 10,406 ± 920 ohms at 1 Hz to approximately 168 ± 28 ohms at 100 Hz. Example 2 similarly illustrates an electrode 26 having circular holes 55A; however, Example 2 comprises two rows of five circular holes 55A each. As shown, the impedance of Example 2 can range from approximately 12,502 ± 552 ohms at 1 Hz to approximately 206 ± 20 ohms at 100 Hz. As will be understood, because Example 2 has a smaller surface area of ​​the electrode 26 coated with coating 27, the covering 54 covers a larger surface area of ​​the electrode 26 and can be more mechanically robust because more covering 54 material can be located between each circular hole 55A.

[0109] Continuing from left to right in Table 1, Example 3 illustrates an electrode 26 having four elongated slits 55E extending from near one end of the electrode 26 to near the second end of the electrode 26. The impedance of Example 3 can be in the range of approximately 7,000 ± 467 ohms at 1 Hz to approximately 109 ± 4 ohms at 100 Hz. Example 4 illustrates an electrode 26 having three rows of elongated slits 55G, wherein each elongated slit 55G extends only a portion of the surface of the electrode 26. Specifically, Example 4 includes three rows of three elongated slits 55G. The impedance of Example 4 can be in the range of approximately 10,544 ± 235 ohms at 1 Hz to approximately 164 ± 8 ohms at 100 Hz. As will be understood, because the elongated slits 55G of Example 4 extend only a portion of the surface of the electrode 26, the coating 27 can be mechanically better protected by the covering 54 compared to Example 3.

[0110] Examples 5 and 6 in Table 1 illustrate electrodes 26 with holes 55, the size of which is set to expose approximately one-third and two-thirds of the electrode 26, respectively. As shown, the impedance value of Example 5 can range from approximately 16,921 ± 4,158 ohms at 1 Hz to 306 ± 77 ohms at 100 Hz, while the impedance value of Example 6 can range from approximately 9,951 ± 407 ohms at 1 Hz to 186 ± 24 ohms at 100 Hz. As will be understood, although the impedance can be reduced by having a larger hole size 55 as shown in Example 6, the coating 27 may have a greater tendency to be damaged because the covering 54 is less capable of providing mechanical protection to the coating 27.

[0111] In the rightmost two columns of Table 1, impedance values ​​for two comparative examples are included for reference. First, a control is shown where electrode 26 has approximately 100% of its surface coated with coating 27. In this example, the total impedance can range from approximately 6,629 ± 197 ohms at 1 Hz to 117 ± 3 ohms at 100 Hz. In the second comparative example, an electrode whose surface is not coated with coating 27 is shown. The impedance value of electrode 26 without any coating 27 can range from approximately 265,513 ± 9,186 ohms at 1 Hz to 3,636 ± 182 ohms at 100 Hz. As illustrated in these two comparative examples, coating 27 can help significantly reduce the total impedance of electrode 26. However, as previously explained, if coating 27 is impacted by a component of basket conduit 10 or other object, coating 27 may be damaged and eventually delaminated. Therefore, by forming a hole 55 through the cover 54 and then coating the surface of the electrode 26 with the coating 27, the disclosed technique can reduce the total impedance and also help to reduce the possibility of damaging the coating 27.

[0112] Now for reference Figure 9 The image is Figure 1A and Figure 1B A schematic diagram of the elongated deflectable element 12 of the basket-shaped conduit 10. The elongated deflectable element 12 can be made of any suitable material, such as polyurethane or polyether block amide. The distal end 14 of the elongated deflectable element 12 has a smaller outer diameter than the rest of the elongated deflectable element 12 to receive the connector 16 at the distal end, such as... Figure 20 As shown herein, the elongated deflectable element 12 includes a lumen 66 for inserting various tubes and wires therein. The elongated deflectable element 12 may have any suitable outer diameter and length, for example, the outer diameter may be in the range of 1 mm to 4 mm, and the length may be in the range of 1 cm to 15 cm.

[0113] Now for reference Figure 10 The image is Figure 1A and Figure 1B A schematic diagram of the flushing sleeve 72 of the basket-shaped conduit 10. The flushing sleeve 72 is installed in the elongated deflectable element 12 ( Figure 9 ) lumen 66 ( Figure 9 A flexible tube within a lumen of ) . The flushing sleeve 72 can be used to deliver flushing fluid to the expandable assembly 22 ( Figure 1A and Figure 1B The flushing sleeve 72 is sized to fit within one lumen (typically the central lumen) of the lumen 66 of the elongated deflectable element 12 and extend beyond the distal end 14 of the elongated deflectable element 12. Figure 9 ),like Figure 20As shown. The inner and outer diameters of the flushing sleeve 72 can be in the range of 3 mm and 5 mm. The flushing sleeve 72 can be formed of any suitable material, such as, but not limited to, polyimide, polyurethane, polyether block amide, or polyethylene terephthalate.

[0114] Now for reference Figure 11 The image is Figure 1A and Figure 1B A schematic diagram of the push rod 18 of the basket-shaped conduit 10. The push rod 18 is a flexible tube and is disposed within the flushing sleeve 72. The dimensions of the push rod 18 are set to slide within the flushing sleeve 72, and space is provided for flushing fluid to pass between the flushing sleeve 72 and the push rod 18. The inner diameter of the push rod 18 is set to accommodate a reference... Figure 12 Wiring of a multi-axis position sensor described. Push rod 18 extends beyond the elongated deflectable element 12 ( Figure 9 The distal end 14 extends to the nose connector 30, as shown. Figure 19 As shown. The push rod 18 can be formed of any suitable material, such as, but not limited to, braided or unbraided polyimide, braided or unbraided polyether ether ketone (PEEK), or braided or unbraided polyamide.

[0115] Now for reference Figure 12 The image is Figure 1A and Figure 1B A schematic diagram of the multi-axis position sensor 74 of the basket-shaped conduit 10. The multi-axis position sensor 74 may include a biaxial or triaxial position sensor, such as a magnetic position sensor including multiple orthogonal coils. Wiring 76 is used for routing through the hollow portion of the push rod 18 ( Figure 11 The multi-axis position sensor 74 is connected to a position calculation system (not shown) located near the basket-shaped conduit 10. Figure 5 and Figure 19 The multi-axis position sensor 74 and wiring 76 are shown in more detail.

[0116] Now for reference Figures 13A to 13B These pictures are Figure 1A and Figure 1B A schematic diagram of the nasal connector 30 of the basket-shaped conduit 10. The nasal connector 30 can be formed of any suitable material, such as, but not limited to, polycarbonate with or without glass filler, PEEK with or without glass filler, or PEI with or without glass filler. The nasal connector 30 includes a proximal cavity 78 ( Figure 13A ), push rod 18 ( Figure 11 ) is fixed in the proximal cavity and the wiring 76 passes through the proximal cavity, such as Figure 19 As shown. Figure 13B The distal jack 34, inner surface 36, and distal opening 38 are also shown. The distal jack 34 accommodates a multi-axis position sensor 74 connected to the inner surface 36. Figure 12 ) and hinge 28 ( Figure 5 ).

[0117] Now for reference Figure 14 The image is Figure 1A and Figure 1B A schematic diagram of the central electrode ring 40 of the basket-shaped conduit 10. The electrode 40 is electrically connected to a wire (not shown) that passes through a slot in the side of the proximal cavity 78 and enters the push rod 18. The central electrode ring 40 can be formed of any suitable material, such as, but not limited to, precious metals and their alloys, including platinum, palladium, gold, or iridium. The central electrode ring 40 passes through the proximal cavity 78 surrounding the nasal connector 30 (… Figure 13A ) provides mechanical support to secure the nose connector 30 to the push rod 18 ( Figure 11 And play a secondary role, such as Figure 19 As shown in the image.

[0118] Now for reference Figures 15A to 15B These figures are schematic diagrams of the nose cap 32 of the basket-shaped conduit 10 in Figure 1. The nose cap 32 includes a hollow cylinder 80 covered with a cover 82, which may be wider than the hollow cylinder 80. The nose cap 32 may be formed of any suitable material, such as, but not limited to, polycarbonate with or without glass filler, PEEK with or without glass filler, or PEI with or without glass filler. The nose cap 32 is sized to fit into the nose connector 30 ( Figure 13B The distal jack 34 ( Figure 13B ) and covers the opening 38 facing the far side ( Figure 13B Meanwhile, a multi-axis position sensor 74 is located in the distal socket. Figure 12 ) and hinge 28 ( Figure 5 Leave space, such as Figure 19 As shown. The size of the nose cap 32 can optionally be set to provide a pressure fit against the hinge 28 to prevent the hinge 28 from being pulled away from the nose connector 30. Figure 13B ) inner surface 36 ( Figure 13B The nose connector 30 can also be used to protect the multi-axis position sensor 74.

[0119] Now for reference Figure 16 The image is Figure 1A and Figure 1B A schematic diagram of the connector 16 of the basket-shaped conduit 10. The connector 16 typically comprises a hollow tube and can be formed of any suitable material, such as, but not limited to, polycarbonate with or without glass filler, PEEK with or without glass filler, polyimide, polyamide, or PEI with or without glass filler. The connector 16 can be sized to have an elongated deflectable element 12 ( Figure 9 The distal end 14 ( Figure 9The inner diameter is the same as the outer diameter of the reference element 12, and the outer diameter is the same as the proximal portion of the elongated deflectable element 12. The dimensions of the connector 16 are also set to surround the reference element. Figure 20 A more detailed description of the various components.

[0120] Now for reference Figure 17 The image is Figure 1A and Figure 1B A schematic diagram of a uniaxial position sensor 86 in a basket-shaped conduit 10. The uniaxial position sensor 86 may include any suitable position sensor, such as a magnetic position sensor comprising a coil wound around a hollow cylinder 88. Wiring (not shown) from the uniaxial position sensor 86 may run along the lumen 66 ( Figure 9 The position calculation system (not shown) is transmitted downwards from one lumen of the basket-shaped conduit 10 to a position calculation system located proximal to the basket-shaped conduit 10. The hollow cylinder 88 is sized to accommodate the flushing sleeve 72 within the hollow cylinder, as shown in the image. Figure 20 As shown. The outer diameter and length dimensions of the single-axis position sensor 86 are set to fit on the connector 16 ( Figure 16 The hollow cylinder 88 can be formed of any suitable material, such as, but not limited to, the material used as a magnetic core.

[0121] Now for reference Figure 18 The image is Figure 1A and Figure 1B A schematic diagram of the proximal retainer ring 84 of the basket-shaped container 10. The proximal retainer ring 84 is configured to provide surrounding the flushing sleeve 72 ( Figure 10 The pressure fit of the distal end of the ) and maintain the uniaxial position sensor 86 ( Figure 17 ) adjacent slender deflectable element 12 ( Figure 9 The distal end 14 ( Figure 9 ),like Figure 20 As shown. The proximal retainer ring 84 is also used to secure the flexible polymer circuit 24 between the retainer ring 84 and the connector 16. The proximal retainer ring 84 may be formed of any suitable material, such as, but not limited to, polycarbonate with or without glass filler, PEEK with or without glass filler, or PEI with or without glass filler.

[0122] Now for reference Figures 19 to 20 These diagrams are along Figure 1B The sectional view taken by line AA. Figure 19 The distal portion of the scalable component 22 is shown, while Figure 20 The proximal portion is shown.

[0123] Figure 19The distal portion 20 of push rod 18 is shown disposed in the proximal cavity 78 of nose connector 30 and secured therein by a central electrode ring 40 disposed externally around the proximal cavity 78. A multi-axis position sensor 74 is disposed in the distal socket 34 of nose connector 30, with wiring 76 extending proximally through push rod 18. A second end 46 of flexible polymer circuit strip 24 is connected to the inner surface 36 of the distal socket 34 of nose connector 30. An elongated elastic support element 48 extends along the length of flexible polymer circuit strip 24 to, but does not include, hinge 28. A nose cap 32 is inserted into the distal socket 34, with a hollow cylinder 80 providing pressure around the distal portion of multi-axis position sensor 74 and against the second end 46 of flexible polymer circuit strip 24. The nose cap 32 covers the distally facing opening 38 of nose connector 30.

[0124] Figure 20 A flushing sleeve 72 is shown disposed within an elongated deflectable element 12. A push rod 18 is disposed within the flushing sleeve 72. Wiring 76 is disposed within the push rod 18. A uniaxial position sensor 86 is disposed around the flushing sleeve 72 (between the connector 16 and the push rod 18), near the distal end 14 of the elongated deflectable element 12. A proximal retainer ring 84 provides a pressure fit around the flushing sleeve 72 and holds the uniaxial position sensor 86 in the appropriate position distal to the distal end 14 of the elongated deflectable element 12. The proximal end of the connector 16 is connected to the distal end 14 of the elongated deflectable element 12. A first end 42 of a flexible polymer circuit strip 24 is connected to the inner surface 44 of the connector 16. Figure 20 An elongated, elastic support element 48 is shown extending along the corresponding strip 24 from the connector 16 to the corresponding hinge 28. Figure 19 )Before.

[0125] Figure 21 Another view of catheter 10 is shown, with annotations illustrating various features of catheter 10. For example, Figure 21 An example of an expandable component 22 is shown, which can be configured to expand to a diameter of approximately 18 mm and may include 10 ridges 24 (each ridge having 10 electrodes 26 (a total of 100 electrodes 26)), with dimensions set to approximately 0.2 mm. 2 The figure shows outward-facing small electrodes (these small electrodes are spaced 1.7 mm from center to center), including the approximate location of the inner central “TruRef” electrode (reference electrode 31), the first position sensor and the second position sensor 74, and the illustration shows that the elongated deflectable element 12 can be about 8 Frenchies in size and can be deflected bidirectionally.

[0126] Figure 22An illustration is shown as a view of the basket catheter 10 rendered on a monitor, showing the basket in both expanded and collapsed states. As shown, the basket catheter 10 can be graphically displayed in various colors and annotations to indicate various orientations and specific ridges, thereby helping to guide the physician 5 in indicating the orientation of the catheter 10 within the patient's heart.

[0127] Although the expandable component 22 is shown not mounted to the flexible membrane, it is also within the scope of the invention that the expandable component may be provided with a membrane (e.g., a balloon-like surface) as a base substrate for the circuit strip. Similarly, the membrane may be used as a covering layer over the circuit strip 24, wherein the electrode 26 is exposed (or not covered by the membrane to be exposed) to the surrounding environment (e.g., the interior of organ tissue).

[0128] Methods and Research Description

[0129] This disclosure can be more clearly understood through the corresponding research and methods described herein. It should be understood that the data presented herein are for illustrative purposes and should not be construed as limiting the scope of the disclosed technology in any way or excluding any alternative or additional embodiments.

[0130] The aforementioned catheter 10 was tested by physicians in a planned single-arm, multicenter study that included patients undergoing catheter mapping and ablation for atrial and ventricular arrhythmias. Mapping was performed using the study catheter 10, and ablation was performed on participants according to investigator standards of care. The primary efficacy endpoint was the completion of pre-ablation electroanatomical mapping without the aid of a non-study catheter. The primary safety endpoint was the incidence of device-related serious adverse events (SAEs) within 7 days. Physician feedback on catheter performance was collected via a 7-point Likert scale.

[0131] As part of the study, forty participants (mean age 58.0 ± 15.73 years, 62.5% male, 30 with atrial arrhythmias and 10 with ventricular arrhythmias) underwent mapping using the study catheter. The primary efficacy endpoint was achieved in all 40 participants; ≥1 region of interest with a mapable rhythm was identified in 23 / 30 participants with atrial arrhythmias. During pre-ablation mapping, only one case of SAE with transient complete atrioventricular block was reported in a patient with persistent atrial fibrillation, who has since fully recovered. Physician feedback indicated that the device met or exceeded expectations for signal quality; most respondents rated the bipolar signal quality in the atria and the noise encountered highly.

[0132] In this first-in-human clinical study, the investigational ultra-high-density spherical catheter achieved its primary safety and efficacy endpoints, demonstrating favorable acute safety and efficacy characteristics for mapping complex arrhythmias. Through its deflectable axis and variable basket deployment, the catheter can access all chambers of the heart. For all study procedures, the protocol-required pre-ablation mapping was performed using the study catheter without switching to another mapping catheter. The safety profile of the study catheter was comparable to that experienced by other commercially available high-density mapping catheters used for atrial and ventricular procedures. Only one SAE was considered catheter-related within seven days of the indexing procedure; three procedure-related SAEs were catheter-independent, and one non-serious AE was considered catheter-related. For all events, participants fully recovered and were discharged within seven days post-procedure. For participants with AT / AFL, PsAF, PAF, VT, and PVC, the mean pre-ablation mapping times were 23.8 minutes, 21.6 minutes, 26.8 minutes, 5.4 minutes, and 17.9 minutes, respectively.

[0133] Like other high-density mapping catheters, the study catheter detected PVI penetration and triggering. The catheter's design facilitates rapid identification of mechanisms maintaining cardiac arrhythmias, thereby enhancing surgical workflow and efficiency. Three embedded magnetic sensors are present in the distal and proximal portions of the bulb, transmitting information to CARTO. ® The 3System allows visualization of baskets with open or closed shapes. Additionally, catheter position and angle information can be transmitted to CARTO independently of higher-level catheter positioning. ® 3. System. Furthermore, the combination of an increased number of closely spaced small, flat electrodes with an internal TRUEref reference electrode provides a larger mapping density with high intracardiac signal resolution. The experience in this study builds on preclinical observations that the TRUEref electrode can filter out far-field ventricular signals and reduce erroneous timing annotations during atrial mapping and around the block line. The swarm intelligence algorithm is able to be based on 1 mm... 3 Specific criteria collected within a predefined FAM region (voxel) are used to reduce outlier error annotations of LAT points.

[0134] Overall, operators rated the study catheter as equal to or better than PENTARAY in confirming PVI, its arrhythmogenicity, and tissue characterization. ® Catheterization. However, this study is limited by the small sample size of participants with a distribution across different arrhythmia subgroups. Participants with the most common arrhythmia mechanisms, rather than a range of arrhythmias, were expected to be included in the study. Ideally, a larger proportion of ischemic VT cases could be added to the study catheter for a more comprehensive assessment, and a larger study with longer follow-up would be a better indicator of efficacy. CARTO ®V7 was the latest CARTO available at the time of this study. ® Version. During the study's surgical period, no other unique features were obtained that were designed to utilize the spherical design of the research catheter.

[0135] Study endpoints

[0136] The primary efficacy endpoint was the completion of protocol-required pre-ablation mapping without the aid of a non-study mapping catheter. The primary safety endpoint was the incidence of device-related serious adverse events (SAEs) within seven days post-procedure.

[0137] Secondary efficacy endpoints were deployment characterization, maneuverability, and signal quality obtained using study catheters in the atria and ventricles based on physician feedback from postoperative investigations. Surveys were collected after each study procedure for each study catheter used and included questions with Likert scale response options for maneuverability and handling, signal acquisition and quality, pacing, catheter design, workflow, visualization, catheter interactions, arrhythmogenicity, design and coverings for confirming the PVI, and the ability to characterize tissue. A score of "4" on a 7-point scale was considered equivalent to other devices. Secondary safety endpoints were the incidence of SAEs excluding study catheter-related SAEs within seven days of the indexing procedure and the incidence of non-serious adverse events (AEs) within seven days of the study catheter-related indexing procedure.

[0138] Additional surgical features include total surgical time, initial mapping duration (the time between the first and last mapping points before the first ablation point, as measured on CARTO), captured regions of interest (e.g., PV triggering, gaps in previous PVI lesions, slow-conduction scar areas, critical isthmuses, etc.), and mapping density.

[0139] Arrhythmia mapping is assessed as an additional endpoint. Atrial reference is used to determine the cycle length of atrial tachycardia (AT). Adjust the window to include the entire atrial cycle length or points on the pre-P wave for atrial flutter (AFL) or focal AT, and set automatic point acquisition (CONFIDENSE) according to individual operator judgment. Ventricular reference is used to determine the cycle of ventricular tachycardia (VT) or premature ventricular contractions (PVC). Adjust the window to include the entire ventricular cycle length or points on the pre-QRS wave for sustained VT or PVC, and set automatic point acquisition (CONFIDENSE) according to operator judgment.

[0140] Research Description

[0141] Eligible participants were scheduled for clinically indicated catheter mapping and ablation procedures for VT, PVC, AT, AFL, or paroxysmal or persistent atrial fibrillation (PAF or PsAF); this may include patients who have undergone prior ablation procedures. Exclusion criteria included diagnoses of arrhythmias requiring epicardial mapping, a left ventricular ejection fraction (LVEF) ≤25% for patients with VT, and an LVEF ≤40% for patients with atrial arrhythmias.

[0142] Preoperative assessment and data collection include baseline medical, cardiac, arrhythmia and ablation history, transthoracic echocardiography, pregnancy test, thrombosis screening, collection of any adverse events (AEs) since enrollment, and subsequent ablations in accordance with institutional care standards (SOC) practices.

[0143] Figure 23A and Figure 23B Further details of the inclusion and exclusion criteria for patients as part of a catheterization study according to an example of the invention are illustrated. As shown, participants in the study must meet various requirements to be eligible to participate, such as being scheduled (2302) for a clinically indicated catheter mapping and ablation procedure for the management of arrhythmias including scar-related atrial tachycardia (AT); persistent atrial fibrillation (PsAF); paroxysmal atrial fibrillation (PAF); ventricular tachycardia (VT); or premature ventricular contractions (PVC). If a patient meets this first requirement, the patient must also be diagnosed (2304) as a candidate for a clinically indicated catheter mapping and ablation procedure for the management of AT, PsAF, PAF, VT, or PVC.

[0144] To be included in the study, patients must have had at least one episode of a targeted arrhythmia recorded by ECG, Holter monitoring, circulatory recorder, telemetry, implantable device, or telephone transmission monitoring within the 12 months of enrollment (2306), be 18 years of age or older (2308), sign a patient informed consent form (2310), and be able (2312) and willing to comply with all pre-testing, post-testing, and follow-up testing and requirements. The study included 40 participants.

[0145] Participants were excluded from the study if any of the following criteria were met (2314): The patient was less than 18 years of age; diagnosed with an arrhythmia requiring epicardial mapping; the arrhythmia was secondary to a reversible cause or secondary to electrolyte imbalance, thyroid disease, or non-cardiac cause; atrial arrhythmias: left atrial size >55 mm; LVEF ≤25% in patients with ventricular arrhythmias; LVEF ≤40% in patients with atrial arrhythmias; a recorded intracardiac thrombus was detected on imaging within 24 hours prior to catheter insertion; contraindications to anticoagulation therapy (i.e., heparin, warfarin, dabigatran); history of coagulation or bleeding abnormalities (e.g., hypercoagulable state); myocardial infarction within the past 2 months (60 days); a thromboembolic event (including TIA) recorded within the past 12 months (365 days); uncontrolled heart failure or NYHA functional class IV; implantation of a pacemaker within the past 6 weeks (42 days). Intracardiac defibrillator; patient with a known untreatable allergy to contrast agents; active disease or active systemic infection or sepsis; diagnosed atrial or ventricular myxoma; atrial baffles or patches; tumors or other abnormalities that would impede catheter insertion or manipulation; significant congenital abnormalities or medical problems that the investigator believes would impede enrollment in this study; subject who has undergone percutaneous or surgical valvular cardiac surgery (i.e., ventriculoperitoneosis, atrialoperitoneosis, and valve repair or replacement, and the presence of prosthetic valves); any cardiac surgery (including PCI) within the past 60 days (2 months); atrial septal closure within the past 6 weeks (42 days); presence of a condition that impedes vascular access; pregnancy (or, if premenopausal, demonstrated by a pregnancy test), breastfeeding, or women of childbearing age and planning pregnancy during the clinical study process; patients classified as vulnerable and requiring special treatment regarding health care; or concurrently enrolled in an investigational study evaluating another device or drug. If a patient meets any of the foregoing criteria, that patient will not be included in the study.

[0146] Figure 24This is a table illustrating the baseline demographics and comorbidities of participants enrolled in the study according to an example of the invention. A total of 40 participants completed the study procedures. The mean age of the participants was 58.0 years, and 25 (62.5%) were male. The majority of participants (38 / 40, 95.0%) did not have structural heart disease. Approximately two-thirds did not have heart failure (27 / 40, 67.5%), while 9 participants (22.5%) had NYHA Class I heart failure, and 2 participants (5.0%) had NYHA Class II heart failure. Of the 30 participants with atrial arrhythmias (7 with AFL, 2 with AT, 7 with PsAF, and 14 with PAF), 16 participants (53.3%) had a history of ≥1 previous ablation procedure performed for the treatment of AF (15 participants), typical AFL (5 participants), AT (2 participants), or atypical AFL (2 participants). These prior ablation procedures were performed using radiofrequency ablation (14 procedures), cryoablation (1 procedure), and other ablation techniques (2 procedures). Among the 10 participants with ventricular arrhythmias (1 with VT and 9 with PVC), 2 participants had previously undergone ablation with radiofrequency catheters for the treatment of AF (1 patient) and PVC (1 patient).

[0147] Figure 25A and Figure 25B This is a table showing the atrial and ventricular arrhythmias and ablation procedures of participants in an example study according to the present invention.

[0148] All participants (40 / 40, 100%) completed the protocol-required pre-ablation mapping using the study catheter. All target cavities for arrhythmia mapping were completed using FAM. No other non-study mapping catheters were used for any pre-ablation mapping.

[0149] The study catheter is used exclusively for all pre-ablation mapping procedures. The catheter is advanced into the chamber of interest via any commercially available 8.5Fr sheath, and a mapping map is created by automated acquisition (CONFIDENSE) of points gated to the respiratory and cardiac cycles. Pre-ablation mapping includes the focal axis (FAM) of the entire chamber and region associated with the target arrhythmia. Electroanatomical mapping is performed to identify the basement voltage or tachycardia activation mechanism, local activation timing (LAT), conduction pathways, gaps, and key isthmuses, and to determine an adequate level of mapping density at the region of interest. A study catheter with a continuous flushing and activation clotting time ≥300 seconds is used. Heparinized saline (1 unit / mL) is infused at a rate of 2 mL / min through the central lumen of the catheter axis, appearing at the distal end of the axis (proximal end of the basket) to prevent thrombosis.

[0150] Following mapping, ablation was performed according to institutional care standards. If additional mapping was clinically ordered post-ablation, a study catheter was used. Phrenic nerve pacing was performed frequently during catheter ablation to assess for any nerve damage to the ablation catheter. The ability of the study catheter to perform phrenic nerve pacing or pacing capture was examined. Follow-up was conducted for 7 days via telephone call or in-person clinical visit to assess adverse events (AEs).

[0151] Figure 26 This is a table of surgical characteristics of procedures performed as part of a study according to an example of the invention. For atrial procedures, the mean total procedure duration was 131.4 minutes (141.1 minutes for participants with AT / AFL, 138.0 minutes for participants with PsAF, and 122.0 minutes for participants with PAF), while the mean total pre-ablation mapping time was 24.7 minutes (23.8 minutes for participants with AT / AFL, 21.6 minutes for participants with PsAF, and 26.8 minutes for participants with PAF). For ventricular procedures, the mean total procedure duration was 116.7 minutes (219.0 minutes for one patient with VT, and 105.3 minutes for participants with PVC), while the mean total pre-ablation mapping time was 16.7 minutes (5.4 minutes for patients with VT, and 17.9 minutes for participants with PVC). Figure 26 ).

[0152] FAM mapping was created in all participants, with voltage mapping created in all 30 atrial procedures and 8 / 10 ventricular procedures. LAT mapping was also created in 25 / 30 atrial procedures and 7 / 10 ventricular procedures. The study catheter was used for phrenic pacing in 5 participants, with local pacing capture demonstrated in all of these procedures. Phrenic nerve stimulation was not performed in any procedure. Post-SOC mapping was also performed in 30 / 40 participants (75.0%).

[0153] No embolic events were reported. At the end of the procedure, the catheter was examined, and no visible thrombi, device malfunctions, or cardiac structural tangles were reported.

[0154] FAM and voltage mapping were performed in all 30 atrial arrhythmia procedures. LAT mapping was performed in 83.3% (25 / 30) of the participants, including all 9 focal AT / AFL procedures (100%), 11 / 14 PAF procedures (78.6%), and 5 / 7 PsAF procedures (71.4%). FAM mapping was also created in 100% (10 / 10) of the participants with ventricular tachycardia. Voltage mapping was performed in 80.0% (8 / 10) of the subjects, and LAT was performed in 70.0% (7 / 10) of the participants.

[0155] Figures 27A to 27D A graphical representation of left atrial atypical flutter timing (LAT) and voltage (bipolar) mapping of a patient's heart using a catheter, according to an example of the present invention. For Figures 27A to 27D Some of the images in the diagram have wave propagation paths annotated. The entire tachycardia cycle length (approximately 240 ms) is plotted and the circuitry is labeled. Regions of low voltage or scarring are also defined using adjusted voltage cutoff values ​​(red < 0.1 mV and purple > 0.5 mV). Figures 27A to 27D As shown, the location and timing of electrophysiological signals propagating through tissue can be mapped and displayed on the monitor for physicians to view in order to help identify the ablation site.

[0156] High-density LAT mapping helps identify and visualize the mechanisms of atypical tachycardia. TRUEref on the catheter. ™ The electrode (reference electrode 31) allows the operator to acquire points with clearer signal quality, thus annotating the signal to the correct near-field component rather than the far-field. Furthermore, based on the density of data collected within a 1-mm³ voxel, the swarm intelligence algorithm effectively and automatically reduces outlier LAT annotations (see [reference]). Figures 27A to 27D ).

[0157] The disclosed techniques may include the ability to filter electrophysiological signals to better identify and display sites of interest. For example, coloring and tolerances may be adjustable (e.g., via a toggle switch or manual change of settings in software) to better highlight the focal point of the arrhythmia and surrounding area that the physician will want to ablate. As will be described in more detail herein, the disclosed techniques may include methods for identifying and highlighting sites, wherein the activation time is within a predetermined duration starting from the earliest activation of the earliest identified activation point (e.g., less than one second, less than 10 milliseconds, less than 1 millisecond). In other examples, additional filters (or alternative filters) may include distances from the earliest activation point (e.g., less than 20 mm, less than 10 mm, less than 5 mm, less than 1 mm). In this way, more precise mapping can be generated and displayed for the physician to identify sites that should be ablated. The physician may vary the time and distance from the earliest activation point to identify ablation sites depending on the type of arrhythmia or other abnormality identified.

[0158] As a non-limiting example, the disclosed technology may include the ability of a physician to set mapping data to show any location where the activation time is within a predetermined time period (e.g., less than one second, less than 10 milliseconds, less than 1 millisecond) and / or within a predetermined distance (e.g., less than 20 millimeters, less than 10 millimeters, less than 5 millimeters, less than 1 millimeter) in a first color (e.g., red) while all other locations are shown in a second color (e.g., purple).

[0159] Figure 28A and Figure 28B This represents an example of an intracardiac electrocardiogram recording of a patient's heart observed via catheter, according to an invention. Far-field ventricular signals are filtered out during atrial tachycardia mapping and around the block line, thereby reducing erroneous annotation.

[0160] The acquired points were automatically annotated with the sharpest maximum negative deflection (-dV / dt), and the earliest pre-P wave atrial signal was depicted using the sharp downward path of the QS complex and focal AT. In contrast, targeting the earliest PV penetration site for venous isolation, 23 / 30 AT participants (76.7%) had one or more regions of interest, such as PV and non-PV triggering identified by the study catheter, PVI penetration, critical isthmus of left atrial flutter, or CTI.

[0161] Figure 29 A graphical representation of a catheter positioned in a patient's heart to perform a mapping procedure, according to an example of the invention, is shown. As illustrated, the pulmonary vein penetration is identified and mapped at the right anterior PV using the study catheter.

[0162] Figure 30 A graphical representation of a catheter positioned in a patient's heart according to an example of the invention is shown, illustrating the site of focal atrial tachycardia before the QS-P wave mapped and identified in the left anterior carina region. As shown, the earliest site of focal atrial tachycardia before the QS-P wave is mapped and identified in the left anterior carina region.

[0163] Figure 31 This is a summary table of regions of interest identified using catheters in participants with atrial tachycardia according to an example of the invention. These regions of interest include PVI triggering, PVI penetration, non-PV AF lesions, critical isthmus of the left atrium, and Cavo tricuspid isthmus.

[0164] Furthermore, according to an example of the present invention, Figure 32 An example is shown of a PVC mapping plot with the earliest pre-QS QRS site identified using a catheter at the RVOT in the septum, and Figure 33 The area and perimeter of the earliest activation timing location less than the predetermined duration, calculated and compared with a mapping reference, are illustrated. Points are automatically annotated to the sharpest maximum negative deflection (-dV / dt), and the earliest intracardiac pre-QRS ventricular signal is depicted using the sharp downward stroke of the QS complex and PVC. Since most ventricular cases are PVC rather than ischemic VT, identifying conduction pathways, gaps, critical isthmuses, and late potentials is not feasible. However, for all nine PVC procedures, the study catheter was able to identify and classify the earliest activation point within the predetermined time (e.g., 10 ms) to 1.08 cm. 2 The average area.

[0165] Figure 34 This is a summary table of all PVC cases that identify the earliest point based on the area of ​​the intermediate QRS (reference), the earliest point before the earliest point QRS, the earliest predetermined duration activation point (e.g., 10 milliseconds), and the perimeter of the earliest 10 millisecond point, according to an example of the present invention.

[0166] Method description

[0167] Figure 35 A flowchart illustrating an example of a method 3500 using a catheter according to an invention is provided. As shown, method 3500 may include identifying 3505 earliest activation points based on electrophysiological data collected by the catheter (catheter 10). Identification of the earliest activation point 3505 may be based on both electrophysiological data collected by electrode 26 and reference electrode 31 and position data collected by position sensor 74. Method 3500 may also include searching for 3510 plurality (e.g., three) nearest mapping points having an activation time less than or equal to a predetermined duration (e.g., less than one second, less than 10 milliseconds, less than 1 millisecond) from the earliest activation time, and creating 3520 circumferential zones using a plurality of concentric circles with radii within one or more predetermined distances (e.g., less than 20 mm, less than 10 mm, less than 5 mm, less than 1 mm) from the earliest activation point, and dividing each concentric zone into three parts.

[0168] Method 3500 may further include: if the difference between the earliest activation time of the given point and the earliest activation time of the earliest activation point is less than a predetermined duration, then searching for the next point within the concentric region 3530. Alternatively, if the difference between the earliest activation time of the given point and the earliest activation time of the earliest activation point is greater than a predetermined duration, then ending the search 3540 using the previously identified point.

[0169] Once all the multiple points within the boundary of the earliest activation point have been identified, method 3500 may further include constructing a contour 3550 around the multiple points and all points between the multiple points whose time differs from the earliest activation point by a predetermined time at the earliest activation point. The method may also include outputting the results to a display so that a physician can observe the recorded data.

[0170] It will be understood that the method 3500 just described can help to more accurately identify the location of the tissue to be ablated. Furthermore, as described above, the disclosed techniques may include enabling physicians to modify set features based on their preferred method and the type of arrhythmia identified, thereby changing the time and distance from the earliest activation point to more accurately identify the ablation location for a given scenario.

[0171] Figure 36A schematic diagram illustrating a method of using a catheter according to an example of the present invention is shown. Mapping points can be identified by measuring the electrophysiological signals of the individual electrodes 26 (three electrodes 26 are shown in this example). Bipolarization can be established between each of the electrodes 26, and mapping points can be identified among multiple electrodes 26. In this way, a more accurate representation of the electrophysiological data can be obtained and displayed to the physician. For example, by using more than one electrode 26 and by establishing bipolarization among multiple electrodes 26, inaccuracies caused by directional wave propagation can be mitigated.

[0172] The disclosed technology described herein can be further understood in accordance with the following terms:

[0173] Clause 1: A method comprising: navigating a medical probe to a target location in a patient's heart, the medical probe extending along a longitudinal axis and including a plurality of ridges configured to bend radially outward from the longitudinal axis, the plurality of ridges including a plurality of electrodes disposed on the plurality of ridges and at least one position sensor disposed on the longitudinal axis, the position sensor being configured to provide a position signal representing the position of the sensor and the medical probe in the heart; receiving electrophysiological signals from at least some of the electrodes of the plurality of electrodes; identifying an earliest activation point identified as having an earliest activation time based on the electrophysiological signals and the position signal; identifying a plurality of points closest to the earliest activation point based on the electrophysiological signals and the position signal, the plurality of points having an activation time less than a predetermined duration from the start of the earliest activation time; and generating an electroanatomical mapping of the heart based on data corresponding to the plurality of points, the electroanatomical mapping representing the location of the earliest activation point for subsequent ablation.

[0174] Clause 2: The method according to Clause 1 further includes: using a plurality of concentric circles having radii less than 10 mm from the earliest activation point to define a circumferential region.

[0175] Clause 3: The method described in Clause 2 further includes: dividing each concentric circle into three parts.

[0176] Clause 4: The method described in Clause 2, wherein the radius is less than 7.5 mm away from the earliest activation point.

[0177] Clause 5: The method described in Clause 2, wherein the radius is less than 5 mm away from the earliest activation point.

[0178] Clause 6: The method according to Clause 2, wherein the radius is less than 2.5 mm away from the earliest activation point.

[0179] Clause 7: The method according to Clause 2, wherein the radius is approximately 1 mm away from the earliest activation point.

[0180] Clause 8: The method according to any one of Clauses 2 to 7 further comprises: identifying additional points in the concentric circles having an activation time less than the predetermined duration starting from the earliest activation time, where the concentric circles include points having an activation time less than the predetermined duration starting from the earliest activation time.

[0181] Clause 9: The method according to any one of Clauses 2 to 7 further comprises: if a corresponding concentric circle in the plurality of concentric circles includes a point having an activation time greater than the predetermined duration starting from the earliest activation time, using a previous point for defining the corresponding concentric circle.

[0182] Clause 10: The method according to Clause 8 or 9 further includes: defining a region based on the plurality of points and any point between the plurality of points that includes an activation time less than the predetermined duration starting from the earliest activation time.

[0183] Clause 11: The method according to any one of the preceding clauses, wherein the plurality of points includes at least three points.

[0184] Clause 12: The method according to any one of the preceding clauses, wherein the plurality of points comprises exactly three points.

[0185] Clause 13: The method according to any one of the preceding clauses, wherein the plurality of ridges comprises ten ridges, and each of the plurality of ridges comprises ten electrodes.

[0186] Clause 14: The method according to any one of the preceding clauses, wherein the electrodes are disposed along a flexible printed circuit on a respective ridge of the plurality of ridges.

[0187] Clause 15: The method according to any one of the preceding clauses, wherein each of the plurality of electrodes is coated with a impedance-reducing coating.

[0188] Clause 16: The method according to any one of the preceding clauses, wherein the medical probe further includes an actuator configured to radially outwardly bend the ridge to define a basket having a diameter adjustable between approximately 3 mm and 18 mm.

[0189] Clause 17: The method according to Clause 16, wherein the electrode is configured to receive electrophysiological data regardless of the diameter of the basket.

[0190] Clause 18: The method according to any one of the preceding clauses, wherein generating the electroanatomical mapping comprises: generating a mapping with a resolution of at least 924 points / minute.

[0191] Clause 19: The method according to Clause 18, wherein the mapping map has a resolution of approximately 1496 points / minute.

[0192] Clause 20: The method according to any one of the preceding clauses, wherein the medical probe further includes a reference electrode disposed in a cavity defined by the plurality of ridges.

[0193] Clause 21: The method according to Clause 20, wherein the reference electrode is configured to receive electrophysiological data for reducing far-field signal components.

[0194] Clause 22: The method according to any one of the preceding clauses, wherein the at least one position sensor includes a first magnetic sensor disposed at the distal end of the plurality of ridges and a second magnetic sensor disposed at the proximal end of the plurality of ridges.

[0195] Clause 23: The method according to any one of the preceding clauses, wherein the medical probe further includes one or more positioning sensing electrodes disposed on the axis of the medical probe, the one or more positioning sensing electrodes being configured for impedance-based positioning sensing.

[0196] Clause 24: The method according to any one of the preceding clauses, wherein the primary safety endpoint of the method includes the absence of one or more serious adverse events within seven days from the generation of the electroanatomical mapping, said serious adverse events including: death, life-threatening illness or injury, permanent damage to body structure or function, hospitalization or prolongation of existing hospitalization, medical or surgical intervention for the prevention of life-threatening illness or injury or permanent damage to body structure or function, chronic disease, or events leading to fetal stillbirth, fetal death, or congenital malformation or birth defect.

[0197] Clause 25: The method according to any one of the preceding clauses, wherein the predetermined duration includes less than or equal to one second.

[0198] Clause 26: The method according to any one of Clauses 1 to 24, wherein the predetermined duration includes less than or equal to 10 milliseconds.

[0199] Clause 27: The method according to any one of Clauses 1 to 24, wherein the predetermined duration includes less than or equal to 5 milliseconds.

[0200] Clause 28: The method according to any one of Clauses 1 to 24, wherein the predetermined duration includes less than or equal to 1 millisecond.

[0201] Clause 29: A medical system comprising: a medical probe including: a shaft extending along a longitudinal axis; a plurality of ridges disposed at a distal end of the shaft and configured to bend radially outward from the longitudinal axis to define a cavity between the plurality of ridges; a position sensor disposed on the longitudinal axis and configured to provide a position signal indicating the position of the sensor and the medical probe in the heart; a plurality of electrodes disposed along the plurality of ridges; and a reference electrode disposed within the cavity; one or more processors; and a memory. The device stores instructions, which, when executed by the one or more processors, are configured to cause the medical system to: receive electrophysiological signals from at least some of the electrodes of the plurality of electrodes; identify an earliest activation point identified as having the earliest activation time based on the electrophysiological signals and the location signals; identify a plurality of points closest to the earliest activation point based on the electrophysiological signals and the location signals, the plurality of points having an activation time less than a predetermined duration from the earliest activation time; and generate an electroanatomical mapping of the heart based on data corresponding to the plurality of points, the electroanatomical mapping indicating the location of the earliest activation point for subsequent ablation.

[0202] Clause 30: In the medical system pursuant to Clause 29, the instructions, when executed by the one or more processors, are further configured to cause the medical system to define a circumferential region using a plurality of concentric circles having radii less than 10 mm from the earliest activation point.

[0203] Clause 31: The medical system according to Clause 30, wherein the instructions, when executed by the one or more processors, are further configured to divide each concentric circle into three parts.

[0204] Clause 32: The medical system according to Clause 30, wherein the radius is less than 7.5 mm away from the earliest activation point.

[0205] Clause 33: The medical system according to Clause 30, wherein the radius is less than 5 millimeters away from the earliest activation point.

[0206] Clause 34: The medical system according to Clause 30, wherein the radius is less than 2.5 mm away from the earliest activation point.

[0207] Clause 35: The medical system according to Clause 30, wherein the radius is approximately 1 mm away from the earliest activation point.

[0208] Clause 36: A medical system according to any one of Clauses 30 to 35, wherein the instructions, when executed by the one or more processors, are further configured to cause the medical system to: identify additional points in the concentric circles having an activation time of less than 10 milliseconds from the earliest activation time, provided that the concentric circles include points having an activation time less than the predetermined duration starting from the earliest activation time.

[0209] Clause 37: A medical system according to any one of Clauses 30 to 36, wherein the instructions, when executed by the one or more processors, are further configured to cause the medical system to: use a previous point for defining the respective concentric circle if the respective concentric circle in the plurality of concentric circles includes a point having an activation time greater than the predetermined duration starting from the earliest activation time.

[0210] Clause 38: A medical system according to Clause 36 or 37, wherein the instructions, when executed by the one or more processors, are further configured to cause the medical system to define a region based on the plurality of points and any points between the plurality of points including activation times less than the predetermined duration starting from the earliest activation time.

[0211] Clause 39: A medical system pursuant to any one of Clauses 29 to 38, wherein the plurality of points comprises at least three points.

[0212] Clause 40: A medical system pursuant to any one of Clauses 29 to 39, wherein the plurality of points comprises exactly three points.

[0213] Clause 41: A medical system according to any one of Clauses 29 to 40, wherein the plurality of ridges comprises ten ridges, and each of the plurality of ridges comprises ten electrodes.

[0214] Clause 42: A medical system according to any one of Clauses 29 to 41, wherein the electrodes are disposed along a flexible printed circuit on a respective ridge of the plurality of ridges.

[0215] Clause 43: A medical probe according to any one of Clauses 29 to 42, wherein each of the plurality of electrodes is coated with an impedance-reducing coating.

[0216] Clause 44: A medical system according to any one of Clauses 29 to 43, wherein the medical probe further includes an actuator configured to radially outwardly bend the ridge to define a basket having a diameter adjustable between approximately 3 mm and 18 mm.

[0217] Clause 45: The medical system according to Clause 44, wherein the electrodes are configured to receive electrophysiological data regardless of the diameter of the basket.

[0218] Clause 46: A medical system pursuant to any one of Clauses 29 to 45, wherein generating the electroanatomical mapping comprises: generating a mapping with a resolution of at least 924 points / minute.

[0219] Clause 47: The medical system pursuant to Clause 46, wherein the mapping has a resolution of approximately 1496 points per minute.

[0220] Clause 48: A medical system according to any one of Clauses 29 to 47, wherein the medical probe further includes a reference electrode disposed in a cavity defined by the plurality of ridges.

[0221] Clause 49: The medical system according to Clause 48, wherein the reference electrode is configured to receive electrophysiological data for reducing far-field signal components.

[0222] Clause 50: A medical system according to any one of Clauses 29 to 49, wherein the medical probe further includes a first magnetic sensor disposed at the distal end of the plurality of ridges and a second magnetic sensor disposed at the proximal end of the plurality of ridges.

[0223] Clause 51: A medical system according to any one of Clauses 29 to 50, wherein the medical probe further includes one or more electrodes disposed on the axis, the one or more electrodes being configured for impedance-based positioning sensing.

[0224] Clause 52: A medical system pursuant to any one of Clauses 29 to 51, wherein the predetermined duration includes less than or equal to one second.

[0225] Clause 53: A medical system pursuant to any one of Clauses 29 to 51, wherein the predetermined duration comprises less than or equal to 10 milliseconds.

[0226] Clause 54: A medical system pursuant to any one of Clauses 29 to 51, wherein the predetermined duration comprises less than or equal to 5 milliseconds.

[0227] Clause 55: A medical system pursuant to any one of Clauses 29 to 51, wherein the predetermined duration comprises less than or equal to 1 millisecond.

[0228] The above embodiments are cited by way of example, and the invention is not limited to the specific details shown and described above. Rather, the scope of the invention includes combinations and sub-combinations of the various features described and shown above, as well as variations and modifications thereof, which will occur to those skilled in the art upon reading the above description and are not disclosed in the prior art.

Claims

1. A method comprising: The medical probe is navigated to a target location in the patient's heart. The medical probe extends along a longitudinal axis and includes a plurality of ridges configured to bend radially outward from the longitudinal axis. The plurality of ridges include a plurality of electrodes disposed on the plurality of ridges and at least one position sensor disposed on the longitudinal axis. The position sensor is configured to provide a position signal indicating the position of the sensor and the medical probe in the heart. Electrophysiological signals are received from at least some of the electrodes among the plurality of electrodes; The earliest activation point, identified as having the earliest activation time, is determined based on the electrophysiological signal and the location signal. Based on the electrophysiological signal and the location signal, a plurality of points closest to the earliest activation point are identified, the plurality of points having an activation time less than a predetermined duration starting from the earliest activation time; as well as An electroanatomical mapping of the heart is generated based on data corresponding to the plurality of points, the electroanatomical mapping indicating the location of the earliest activation point for subsequent ablation.

2. The method according to claim 1, further comprising: The circumferential region is defined by using multiple concentric circles with radii less than 10 mm away from the earliest activation point.

3. The method according to claim 2, further comprising: Divide each concentric circle into three parts.

4. The method according to claim 2, further comprising: In the case where the concentric circles among the plurality of concentric circles include a point having an activation time less than the predetermined duration starting from the earliest activation time, an additional point in the concentric circles having an activation time less than the predetermined duration starting from the earliest activation time is identified.

5. The method according to claim 2, further comprising: In cases where a corresponding concentric circle in the plurality of concentric circles includes a point having an activation time greater than the predetermined duration starting from the earliest activation time, a previous point used to define the corresponding concentric circle is used.

6. The method according to claim 2, further comprising: The region is defined based on the plurality of points and any points between the plurality of points that have an activation time less than the predetermined duration, starting from the earliest activation time.

7. The method according to claim 6, wherein, The plurality of points includes at least three points.

8. The method according to claim 1, wherein, The plurality of ridges includes ten ridges, and each of the plurality of ridges includes ten electrodes.

9. The method according to claim 1, wherein, The electrodes are disposed along the flexible printed circuit on the corresponding ridges of the plurality of ridges.

10. The method according to claim 1, wherein, Each of the plurality of electrodes is coated with a impedance-reducing coating.

11. The method according to claim 1, wherein, The medical probe also includes an actuator configured to bend the ridge radially outward to define a basket having a diameter adjustable between approximately 3 mm and 18 mm.

12. The method according to claim 1, wherein, Generating the electroanatomical mapping includes generating a mapping with a resolution of at least 924 points / minute.

13. The method according to claim 1, wherein, The medical probe also includes a reference electrode disposed within a cavity defined by the plurality of ridges.

14. The method according to claim 13, wherein, The reference electrode is configured to receive electrophysiological data for reducing far-field signal components.

15. The method according to claim 1, wherein, The at least one position sensor includes a first magnetic sensor disposed at the distal end of the plurality of ridges and a second magnetic sensor disposed at the proximal end of the plurality of ridges.

16. The method according to claim 1, wherein, The medical probe also includes one or more positioning sensing electrodes disposed on the axis of the medical probe, the one or more positioning sensing electrodes being configured for impedance-based positioning sensing.

17. The method according to claim 1, wherein, The predetermined duration includes less than or equal to 10 milliseconds.

18. A medical system comprising: Medical probe, the medical probe comprising: A shaft, which extends along a longitudinal axis; A plurality of ridges are disposed at the distal end of the shaft and configured to bend radially outward from the longitudinal axis to define a cavity between the plurality of ridges; A position sensor, disposed on the longitudinal axis, is configured to provide a position signal indicating the position of the sensor and the medical probe in the heart; Multiple electrodes, the multiple electrodes being disposed along the multiple ridges; and A reference electrode is disposed in the cavity; One or more processors; and The memory stores instructions that, when executed by the one or more processors, are configured to cause the medical system to: Electrophysiological signals are received from at least some of the electrodes among the plurality of electrodes; The earliest activation point, identified as having the earliest activation time, is determined based on the electrophysiological signal and the location signal. Based on the electrophysiological signal and the location signal, a plurality of points closest to the earliest activation point are identified, the plurality of points having an activation time less than a predetermined duration starting from the earliest activation time; and An electroanatomical mapping of the heart is generated based on data corresponding to the plurality of points, the electroanatomical mapping indicating the location of the earliest activation point for subsequent ablation.

19. The medical system according to claim 18, wherein, When executed by the one or more processors, the instructions are further configured to cause the medical system to define a circumferential region using a plurality of concentric circles having a radius less than 10 mm from the earliest activation point.

20. The medical system according to claim 19, wherein, The instructions, when executed by the one or more processors, are also configured to divide each concentric circle into three parts.

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