Mapping and navigation systems

Abstract

This specification provides systems, devices, and methods for performing medical procedures on patients. The system includes a catheter device and a console for operating the catheter device. The catheter device includes a functional assembly located at the distal end of a catheter and containing one or more electrodes. The console includes a diagnostic module for recording signals from the electrodes and a processing unit for processing the recorded signals.

Description

[Technical Field]

[0001] Cross-reference of related applications This application claims priority to U.S. Provisional Patent Application No. 63 / 503,665 (Reference No. ENC-001-PR1), filed on 22 May 2023, entitled “Basket Catheter Comprised of Flex Circuits with Electrodes on Both Sides of the Splines,” and to U.S. Provisional Patent Application No. 63 / 506,314 (Reference No. ENC-001-PR2), filed on 5 June 2023, entitled “Hybrid Navigation of the Catheter Using Both Magnetic and Impedance Fields,” the contents of each of these applications are incorporated herein by reference in their entirety for all purposes.

[0002] Field of the Concept of the Invention The concept of the present invention generally relates to systems, devices, and methods for diagnosing cardiac diseases, particularly for mapping cardiac electrical activity. [Background technology]

[0003] Some medical procedures involve treating cardiac disease using catheter devices inserted near the patient's heart (e.g., into the cardiac chambers). Identifying diseased tissue, as well as tracking the position and orientation of the various devices used to identify and / or treat the tissue, can be challenging, and this difficulty may lead to poor clinical outcomes. [Prior art documents] [Patent Documents]

[0004] [Patent Document 1] U.S. Patent Application Publication No. 2014 / 180051 [Patent Document 2] U.S. Patent Application Publication No. 2022 / 226046 [Patent Document 3] U.S. Patent Application Publication No. 2020 / 138525 [Patent Document 4] U.S. Patent Application Publication No. 2022 / 054192 [Patent Document 5] U.S. Patent Application Publication No. 2015 / 351652 [Patent Document 6] U.S. Patent Application Publication No. 2019 / 314083 [Overview of the Initiative] [Problems that the invention aims to solve]

[0005] There is a need for systems, methods, and devices to improve the diagnosis and treatment of cardiac diseases. [Means for solving the problem]

[0006] According to one aspect of the concept of the present invention, a system for performing a medical procedure on a patient comprises a catheter device comprising a distal portion including a distal end, and a functional assembly located in the distal portion of the catheter, the functional assembly comprising one or more electrodes. The system further comprises a console for operating the catheter device, comprising a diagnostic module configured to record signals from at least one of the one or more electrodes, and a processing unit configured to process the recorded signals.

[0007] In some embodiments, the functional assembly comprises a distal surface, the distal surface including the distal end of the catheter device.

[0008] In some embodiments, the catheter device further comprises a magnetic sensor. The magnetic sensor may comprise two or more magnetic sensors. The functional assembly may comprise a magnetic sensor. The magnetic sensor may be configured to provide signals related to the position, orientation, and / or geometric configuration of the functional assembly. The magnetic sensor may include a 5-degree-of-freedom magnetic sensor. The magnetic sensor may include a 6-degree-of-freedom magnetic sensor.

[0009] In some embodiments, the functional assembly further comprises a plurality of splines, each spline comprising at least one of one or more electrodes. The plurality of splines may comprise at least four splines. The plurality of splines may comprise at least eight splines. Each of the plurality of splines may include a flat sheet. Each of the plurality of splines may comprise a material selected from the group consisting of nickel-titanium alloy, stainless steel, polyethyleneimine (PEI), polyimide, and combinations thereof. Each spline of the plurality of splines may comprise a first side and a second side.

[0010] In some embodiments, one or more electrodes comprise one or more electrodes of a first set positioned on the first side of the first spline of the plurality of splines, and one or more electrodes of a second set positioned on the second side of the first spline.

[0011] In some embodiments, each of the first and second sets of one or more electrodes comprises at least 3, 6, 8, 10, 12, 14, or 16 electrodes.

[0012] In some embodiments, each electrode in the first set of electrodes comprises a corresponding electrode in the second set of electrodes, and the corresponding electrodes include a pair.

[0013] In some embodiments, each electrode pair from the first set of electrodes and the second set of electrodes is aligned axially along the length of the first spline.

[0014] In some embodiments, each electrode pair from a first set of electrodes and a second set of electrodes is axially offset along the length of the first spline. The system may further comprise one or more flex circuits, each flex circuit may be mounted on each spline of the plurality of splines, and each spline may comprise at least one of the one or more electrodes. Each flex circuit may be joined and / or laminated to each spline. Each spline of the plurality of splines may comprise a first side and a second side. One or more flex circuits may comprise a first flex circuit mounted on the first side of the first spline of the plurality of splines, and a second flex circuit mounted on the second side of the first spline. One or more flex circuits may comprise a first flex circuit comprising a first portion and a second portion, the first portion of which may be mounted on the first side of the first spline of the plurality of splines, and the second portion of which may be mounted on the second side of the first spline. The multiple electrodes may comprise one or more electrodes of a first set positioned in a first portion of the flexible circuit, and one or more electrodes of a second set positioned in a second portion of the flexible circuit. The system may further comprise a control assembly comprising a puller tube, which may be configured to radially expand and / or contract the functional assembly. The control assembly may further comprise a housing, the functional assembly may comprise a distal end, and the housing may connect the puller tube to the distal end of the functional assembly. The housing may comprise a first navigation element, which may comprise a magnetic sensor. The catheter device may further comprise a second navigation element, which may comprise a magnetic sensor. The second navigation element may be positioned near and proximal to the functional assembly. The catheter device may further comprise a shaft comprising a distal end and a coupler housing positioned near the distal end, the coupler housing may connect the functional assembly to the distal end of the shaft, and the second navigation element may be positioned within the coupler housing.

[0015] In some embodiments, the functional assembly includes a diameter of at least 12 mm, 35 mm or less, or both.

[0016] In some embodiments, one or more electrodes include a material selected from the group consisting of gold, platinum, platinum iridium, iridium oxide, PDOT conductive polymer, titanium nitride, graphene, noble metal alloys, and combinations thereof.

[0017] In some embodiments, one or more electrodes include a coating selected from the group consisting of a gold coating, a coating configured to reduce the input impedance of the electrode, a PDOT coating, an iridium oxide coating, a titanium nitride coating, an oxide coating, and combinations thereof.

[0018] In some embodiments, the catheter device comprises at least a first catheter, and the system comprises a navigation subsystem, a magnetic-based navigation assembly comprising: (i) a magnetic generator positioned adjacent to the patient's body, the magnetic generator generating a magnetic field; (ii) at least one magnetic sensor coupled to the first catheter and configured to generate a first signal based on the magnetic field, the first signal being associated with a three-dimensional spatial position inside the patient's body; and (iii) a magnetic navigation module configured to receive and process the first signal, the magnetic navigation module calculating a three-dimensional spatial position based on the first signal; and an impedance-based navigation assembly comprising: (i) a plurality of surface patches attached to the patient's body; and (ii) a multi-axis An impedance-based navigation assembly comprising an impedance navigation module configured to output multiple impedance-localized signals to a surface patch in order to generate an impedance-localized field, wherein one or more electrodes of a functional assembly are configured to generate one or more second signals correlated to the positions of relevant electrodes in a multi-axis impedance-localized field, each of the one or more second signals comprising at least magnitude and phase values, and the impedance navigation module further receives and processes one or more second signals from one or more electrodes; and a navigation subsystem further comprising a conversion module configured to establish an impedance conversion matrix between the second signals and the three-dimensional spatial position inside the patient's body based on a first signal and a physical relationship between at least one magnetic sensor and one or more electrodes. The conversion module may be configured to establish a magnetic conversion matrix, and the magnetic navigation module may use the magnetic conversion matrix to calculate the three-dimensional spatial position of at least one magnetic sensor.The impedance transformation matrix can be calibrated by fitting a catheter model template with a measured impedance field to a three-dimensional spatial position. The catheter model template can be derived from mathematical equations based on the position of at least one magnetic sensor, and the physically constrained separation distance and / or orientation of one or more electrodes of a functional assembly. The catheter model template can be determined from a lookup table of a predefined set of physical measurements. The physical measurements may relate to the range of deployment levels of the functional assembly and / or the set of geometric configurations of the functional assembly. The navigation subsystem may be configured to calculate the distance and / or angle between two or more of the at least one magnetic sensor, and the navigation subsystem may be further configured to calculate the position of one or more of the one or more electrodes based on the calculated distance and / or angle, and the catheter model template. The navigation subsystem may be configured to assume a nonlinear relationship between the multi-axis impedance localization field and the three-dimensional space within the patient. The navigation subsystem may be configured to divide the volume within the patient into a set of cubic voxel cells, the cells may establish a relationship between a second signal and the three-dimensional position of one or more electrodes. Each cubic voxel cell may have a length of at least 2 mm and / or 20 mm or less. The impedance transformation matrix may include a transformation matrix for each cell in the set of cubic voxel cells. The navigation subsystem may be further configured to calculate the average error on the transformation matrix of the cells in the set of cubic voxel cells and to update the transformation matrix if the error exceeds a threshold. The magnetic navigation module may be configured to determine the optimal torsion angle of the functional assembly. The optimal torsion angle may be determined based on a first signal from at least one magnetic sensor. The at least one magnetic sensor may comprise at least two magnetic sensors, including a 5-degree-of-freedom magnetic sensor. The at least one magnetic sensor may include a 6-degree-of-freedom magnetic sensor. The first catheter may be at least one of a mapping catheter, an ablation catheter, and / or a diagnostic catheter.The catheter device may further comprise at least a second catheter, the second catheter not comprising a magnetic sensor, and an impedance transformation matrix may be used to localize the second catheter. The second catheter may include at least one of a mapping catheter, an ablation catheter, and / or a diagnostic catheter. Each of the multiple signals may have the same or different frequencies. The system may further comprise one or more surface magnetic sensors attached to the patient's skin and configured to generate a third signal, and the system may be configured to compensate for the patient's body movements based on the third signal. One or more of the multiple surface patches may each comprise one or more surface magnetic sensors. The third signal may be used to track the movement of the patient's torso relative to a magnetic field generated by a magnetic generator. The system may further comprise a mathematical transformation used to remove the body movement component from the localization information. The mathematical transformation may include a linear transformation selected from the group consisting of identity, translation, rotation, scale, shear, and combinations thereof. The transformation may include a scale transformation that may be used by the system to compensate for respiratory movements. Multiple surface patches and / or impedance-localized signals may be configured to avoid null points in the region of interest. The system may be configured to compute data provided as if recorded from one or more virtual electrodes and / or one or more virtual magnetic sensors. The navigation subsystem may be configured to determine the expected shape of the functional assembly based on the identified catheter model and the unfolded geometric shape of the functional assembly. The navigation subsystem may be further configured to determine the unfolded geometric shape of the functional assembly based on a first signal from at least one magnetic sensor. The system may further include a force sensor configured to measure the unfolding force of the functional assembly, and the navigation subsystem may be further configured to determine the unfolded geometric shape based on the unfolding force. The navigation subsystem may be configured to compensate for respiratory and / or cardiac artifacts by subtracting the signal reconstructed on an orthogonal basis, so that the signal represents the artifact.The navigation subsystem may be further configured to determine whether the respiratory and / or cardiac motion patterns have changed and to update the orthogonal basis if the patterns have changed. The orthogonal basis may be updated within a time-shifted window. The navigation subsystem may be further configured to estimate respiratory and / or cardiac motion by fitting a periodic or quasi-periodic signal to the first and / or second signal. The navigation subsystem may be configured to compensate for respiratory and / or cardiac artifacts using a frequency-selective filter. The frequency-selective filter may remove frequency components higher than 1 Hz.

[0019] According to another aspect of the concept of the present invention, a method for localizing a catheter without a magnetic sensor is to (a) obtain an impedance transformation matrix between a measured impedance field and a three-dimensional spatial position inside the patient's body, (i) insert a first catheter into the patient's body, the first catheter comprising a magnetic sensor and first electrodes configured to form a reference pair, and (ii) manipulate the first catheter inside the patient's body while recording a first set of signals from the magnetic sensor and a second set of signals from the first electrodes, the first set of signals being from the magnetic sensor inside the patient's body The process includes: (iii) establishing a dictionary based on the position of a magnetic sensor and a second set of signals recorded from the first electrode, which corresponds to a three-dimensional spatial position; (b) storing the dictionary; and (c) estimating the position of the second electrode of the second catheter by (i) recording a third set of signals from the second electrode of the second catheter and (ii) estimating the position of the second electrode of the second catheter based on the third set of signals and an impedance transformation matrix, and / or by using an algorithm performed in a global coordinate system defined by the dictionary. The second catheter does not have a magnetic sensor, and the second set of signals and the third set of signals include impedance-based signals.

[0020] In some embodiments, the second catheter includes an ablation and / or diagnostic catheter.

[0021] In some embodiments, the conversion is used to localize a catheter that does not have a magnetic coil.

[0022] The technologies described herein, along with their attributes and associated advantages, will be best recognized and understood by considering the following detailed description in conjunction with the accompanying drawings, which illustrate typical embodiments.

[0023] Embedding by reference All publications, patents, and patent applications referenced herein are incorporated herein by reference to the same extent as each individual publication, patent, or patent application would be specifically and individually incorporated by reference. For all purposes, the entire contents of all publications, patents, and patent applications referenced herein are incorporated herein by reference. [Brief explanation of the drawing]

[0024] [Figure 1] This is a block diagram of one embodiment of a diagnostic mapping system consistent with the concept of the present invention. [Figure 1A] This is a block diagram of another embodiment of a diagnostic mapping system consistent with the concept of the present invention. [Figure 2] This is a side view of one embodiment of a catheter including a handle and a functional assembly, consistent with the concept of the present invention. [Figure 3] This is a perspective view of the distal portion of one embodiment of a catheter including a basket-like functional assembly, consistent with the concept of the present invention. [Figure 4] This is a side view of the distal portion of one embodiment of a catheter including a basket-like functional assembly, consistent with the concept of the present invention. [Figure 4A] Figure 3 is a cross-sectional view of the functional assembly consistent with the concept of the present invention. [Figure 5A]These are side views of various embodiments of a spline for a functional assembly, including staggered and aligned electrodes, consistent with the concept of the present invention. [Figure 5B] These are side views of various embodiments of a spline for a functional assembly, including staggered and aligned electrodes, consistent with the concept of the present invention. [Figure 6A] This is an anatomical diagram showing an embodiment of a patch electrode arrangement configuration consistent with the concept of the present invention. [Figure 6B] This is an anatomical diagram showing an embodiment of a patch electrode arrangement configuration consistent with the concept of the present invention. [Figure 7A] This is a perspective view of a catheter having various embodiments of a functional assembly including electrodes and a magnetic sensor, consistent with the concept of the present invention. [Figure 7B] This is a perspective view of a catheter having various embodiments of a functional assembly including electrodes and a magnetic sensor, consistent with the concept of the present invention. [Figure 7C] This is a perspective view of a catheter having various embodiments of a functional assembly including electrodes and a magnetic sensor, consistent with the concept of the present invention. [Figure 7D] This is a perspective view of a catheter having various embodiments of a functional assembly including electrodes and a magnetic sensor, consistent with the concept of the present invention. [Figure 8] This is a flowchart of a method for localizing a catheter, consistent with the concept of the present invention. [Figure 9] This is a flowchart of a method for updating a dictionary grid, consistent with the concept of the present invention. [Figure 10] This is a flowchart of a method for estimating electrode positions based on an impedance transformation matrix, consistent with the concept of the present invention. [Figure 11] This is a flowchart illustrating a method for estimating electrode positions using a hybrid algorithm, consistent with the concept of the present invention. [Figure 12] This is a schematic plot for obtaining the optimal twist angle in a local coordinate system, consistent with the concept of the present invention. [Figure 13]This is a flowchart of a method for compensating for respiration and cardiac movement, consistent with the concept of the present invention. [Modes for carrying out the invention]

[0025] The following describes in detail embodiments of the technology illustrated in the accompanying drawings. Similar reference numerals may be used to refer to similar components. However, the description is not intended to limit this disclosure to any particular embodiment and should be construed as including various modifications, equivalents, and / or substitutions of the embodiments described herein.

[0026] It will be understood that the words “comprising” (and any form of “comprising,” e.g., “comprise” and “comprises”), “having” (and any form of “having,” e.g., “have” and “has”), “including” (and any form of “including,” e.g., “includes” and “include”), or “containing” (and any form of “contains” and “contain”), as used herein, identify the presence of a described feature, integer, step, action, element, and / or component, but do not preclude the presence or addition of one or more other features, integers, steps, actions, elements, components, and / or groups thereof.

[0027] Furthermore, while terms such as "first," "second," and "third" may be used herein to describe various limitations, elements, components, regions, layers, and / or sections, it will be understood that these limitations, elements, components, regions, layers, and / or sections should not be limited by these terms. These terms are used solely to distinguish one limitation, element, component, region, layer, or section from another limitation, element, component, region, layer, or section. Accordingly, the first limitation, element, component, region, layer, or section discussed below can be terminologically designated as the second limitation, element, component, region, layer, or section without departing from the teachings of this application.

[0028] When an element (also referred to herein as a “component”) is described as being “on top of,” “attached,” “connected,” or “linked” to another element, it will be further understood that it may be directly on top of or higher than the other element, or connected or linked to it, or there may be one or more intervening elements. In contrast, when an element is described as being “directly on top of,” “directly attached,” “directly connected,” or “directly linked” to another element, there are no intervening elements. Other words used to describe relationships between elements should be interpreted similarly (e.g., “between” versus “directly between,” “adjacent” versus “directly adjacent,” etc.).

[0029] As used herein, the terms “operably mounted,” “operably connected,” “operably coupled,” and similar terms relating to the mounting of components refer to the mounting of two or more components that result in one, two or more of the following operable mounting configurations: electrical mounting, fluid mounting, magnetic mounting, mechanical mounting, optical mounting, acoustic mounting, and / or other operable mounting configurations. An operable mounting of two or more components can facilitate the transmission of power, signals, electrical energy, fluids or other fluid materials, magnetism, mechanical coupling, light, sound such as ultrasound, and / or other materials and / or components between the two or more components.

[0030] Where the first element is referred to as being "inside," "on top of," and / or "within" the second element, it will be further understood that the first element may be positioned within the internal space of the second element, within a portion of the second element (for example, within the walls of the second element), on the external and / or internal surfaces of the second element, and in any combination of these.

[0031] As used herein, the term “proximity” should be interpreted as including, when used to describe the proximity of a first component or location to a second component or location, one or more locations close to the second component or location, as well as locations within, above, and / or inside the second component or location. For example, a component located in proximity to an anatomical site (e.g., a blood or other fluid delivery site) would include components located near the anatomical site, as well as components located within, above, and / or inside the anatomical site.

[0032] Spatial terms, such as “directly below,” “below,” “downward,” “above,” “up,” and “below,” may be used to describe the relationship of an element and / or feature to another element and / or feature, for example, as shown in the drawings. Furthermore, it will be understood that spatial terms are intended to encompass different orientations of a device in use and / or operation, in addition to the orientation shown in the drawings. For example, if the device in the drawing is inverted, the element described as “below” and / or “directly below” another element or feature will be oriented towards the other element or feature “above.” The device may be oriented in other ways (e.g., rotated 90 degrees or in other orientations), and the spatial descriptions used herein shall be interpreted accordingly.

[0033] The terms “reduce,” “reducing,” and “reduction,” as used herein, shall include a reduction in quantity, including a reduction to zero. Reducing the likelihood of occurrence shall include preventing occurrence. Correspondingly, the terms “prevent,” “preventing,” and “prevention” shall include the actions of “reduce,” “reducing,” and “reduction,” respectively.

[0034] As used herein, the terms “and / or” should be interpreted as specific disclosures of each of two identified features or components, with or without the other. For example, “A and / or B” should be interpreted as specific disclosures of (i) A, (ii) B, and (iii) A and B, each as described separately herein.

[0035] As used herein, the term "one or more" may mean one, two, three, four, five, six, seven, eight, nine, ten, or any number greater than one.

[0036] The terms “and combinations thereof” and “and combinations thereof” may be used herein after a list of items to be included individually or collectively. For example, a component, process, and / or other item selected from the group consisting of A, B, C and combinations thereof shall include one, two, three or more items A, one, two, three or more items B, and / or one, two, three or more items C, comprising one or more components.

[0037] In this specification, unless expressly stated otherwise, “and” may mean “or,” and “or” may mean “and.” For example, if a feature is described as having A, B, or C, that feature may have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, that feature may have only one or two of A, B, or C.

[0038] When used herein, if a quantifiable parameter is described as having a value "between" a first value X and a second value Y, it shall include a parameter having a value of at least X, Y or less, and / or at least X and Y or less. For example, the length between 1 and 10 shall include a length of at least 1 (including values ​​greater than 10), a length less than 10 (including values ​​less than 1), and / or a value greater than 1 and less than 10.

[0039] As used in this disclosure, the expression "configured (or set up) to..." may be used interchangeably with expressions such as "suitable for...", "capable of...", "designed to...", "adapted to...", "made to...", and "capable of...", depending on the context. The expression "configured (or set up) to..." does not mean "specifically designed" in hardware. Alternatively, in some contexts, the expression "device configured to..." may mean that the device "can" operate with another device or component.

[0040] As used herein, the terms “about” or “approximately” refer to ±20% of the stated value.

[0041] As used herein, the term “threshold” refers to the maximum level, minimum level, and / or range of a value that correlates with a desired or undesirable state. In some embodiments, system parameters are maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values, for example, to produce a desired effect (e.g., effective treatment) and / or to prevent or otherwise reduce (hereinafter “prevent”) an undesirable event (e.g., device and / or clinical adverse event). In some embodiments, system parameters are maintained above a first threshold (e.g., above a first temperature threshold to produce a desired therapeutic effect on tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesirable tissue damage). In some embodiments, thresholds are determined to include a safety margin to account for, for example, patient, user, and / or operator variability, system variability, and tolerances. As used herein, “above a threshold” means that a parameter is above a maximum threshold, below a minimum threshold, within a threshold range, and / or outside a threshold range.

[0042] Where used herein, “room pressure” means the pressure in the environment surrounding the systems and devices of the present invention. Positive pressure includes pressure above the room pressure, or simply pressure greater than another pressure, such as a positive differential pressure across fluid path components such as valves. Negative pressure includes pressure below the room pressure, or pressure less than another pressure, such as a negative differential pressure across fluid path components such as valves. Negative pressure may include a vacuum, but does not mean pressure below a vacuum. Where used herein, the term “vacuum” may be used to mean a complete or partial vacuum, or any negative pressure as described above.

[0043] When used herein to describe a non-circular shape, the term “diameter” should be interpreted as the diameter of a hypothetical circle that approximates the shape being described. For example, when describing a cross-section, such as the cross-section of a component, the term “diameter” should be interpreted as representing the diameter of a hypothetical circle having the same cross-sectional area as the cross-section of the component being described.

[0044] As used herein, the terms “major axis” and “minor axis” refer to the length and diameter of a hypothetical cylinder with the smallest volume that can completely enclose the component, respectively.

[0045] As used herein, the term “functional element” should be interpreted as including one or more elements configured and arranged to perform a function. A functional element may comprise sensors and / or transducers. In some embodiments, a functional element is configured to deliver energy. In some embodiments, a functional element is configured to treat tissue (e.g., a functional element configured as a treatment element). Alternatively or additionally, a functional element (e.g., a functional element comprising sensors) may be configured to record one or more parameters, such as patient physiological parameters, patient anatomical parameters (e.g., tissue morphology parameters), patient environmental parameters, and / or system parameters. In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g., to collect data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g., to deliver therapeutic energy and / or therapeutic drugs). In some embodiments, a functional element comprises one or more elements configured and arranged to perform functions selected from a group consisting of delivering energy, extracting energy (e.g., to cool components), delivering drugs or other agents, manipulating system components or patient tissue, recording or otherwise sensing parameters such as patient physiological parameters or system parameters, and one or more combinations thereof. A functional element may comprise a fluid and / or fluid delivery system. A functional element may comprise a reservoir, e.g., an expandable balloon or other fluid-holding reservoir. A “functional assembly” may comprise an assembly configured and arranged to perform functions such as diagnostic and / or therapeutic functions. A functional assembly may comprise an expandable assembly. A functional assembly may comprise one or more functional elements.

[0046] As used herein, the term “transducer” should be interpreted as including any component or combination of components that receive energy or any input and produce an output. For example, a transducer may include electrodes that receive electrical energy and distribute the electrical energy to tissue (for example, based on the size of the electrodes). In some configurations, a transducer converts an electrical signal into any output, e.g., light (e.g., a transducer comprising a light-emitting diode or a light bulb), sound (e.g., a transducer comprising a piezoelectric crystal configured to deliver ultrasonic energy), pressure (e.g., applied pressure or force), thermal energy, cryogenic energy, chemical energy, mechanical energy (e.g., a transducer comprising a motor or a solenoid), magnetic energy, and / or a different electrical signal (e.g., different from the input signal to the transducer). Alternatively or additionally, a transducer may convert a physical quantity (e.g., a variation of a physical quantity) into an electrical signal. A transducer may include any components that deliver energy and / or drugs to tissue, for example, a transducer may be configured to deliver electrical energy to tissue (e.g., a transducer having one or more electrodes), light energy to tissue (e.g., a transducer having optical components such as a laser, light-emitting diode, and / or lens or prism), mechanical energy to tissue (e.g., a transducer having tissue manipulation elements), sound energy to tissue (e.g., a transducer having piezoelectric crystals), chemical energy, electromagnetic energy, magnetic energy, and one or more combinations thereof.

[0047] As used herein, the term “fluid” may mean a liquid, gas, gel, or any flowable material, such as a material that can be propelled through a lumen and / or opening.

[0048] As used herein, the term “material” may refer to a single material or a combination of two, three, four, or more materials.

[0049] As used herein, the term “user interface” may include one or more interfaces, each interface including one or more components configured to receive input from a user, referred to herein as a “user input device,” and / or one or more components configured to provide output to a user, referred to herein as a “user output device.”

[0050] The terms "data" and "information" are used interchangeably in this specification.

[0051] For clarity, it is understood that certain features of the concept of the present invention described in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the concept of the present invention described in the context of a single embodiment may be provided separately or in any suitable partial combination. For example, it will be understood that all features described in any of the claims (whether independent or dependent) may be combined in any given manner.

[0052] At least some of the drawings and descriptions of the concept of the present invention have been simplified in order to focus on elements relevant to a clear understanding of the concept of the present invention, and for the sake of clarity, other elements that a person skilled in the art would understand may also constitute part of the concept of the present invention should be understood. However, since such elements are well known in the art and do not necessarily facilitate a better understanding of the concept of the present invention, a description of such elements is not provided herein.

[0053] The terms defined herein are used solely to describe specific embodiments of the disclosure and are not intended to limit the scope of the disclosure. Terms provided in the singular form are intended to also include the plural form unless the context clearly indicates otherwise. All terms used herein, including technical or scientific terms, have the same meaning as commonly understood by those skilled in the art unless otherwise defined herein. Terms defined in commonly used dictionaries should be interpreted as having the same or similar meaning as in the context of the art and not as having an ideal or exaggerated meaning unless expressly defined herein. In some cases, terms defined herein should not be interpreted as excluding embodiments of the disclosure.

[0054] This specification provides systems, devices, and methods for diagnosing cardiac disease, including by mapping cardiac electrical activity to identify undesirable conduction pathways. A catheter comprising a functional assembly may include one or more electrodes for recording cardiac electrical activity. The catheter may include one or more magnetic sensors for localizing the catheter within a patient. The system may include a console for operating the catheter, the console comprising a diagnostic module for recording signals from one or more electrodes, and a processing unit for processing the recorded signals.

[0055] Referring here to Figure 1, a block diagram of one embodiment of a diagnostic mapping system consistent with the concept of the present invention is shown. System 10 may be configured to map electrical magnitude, morphology, conduction pathways, physiological state, and / or other electrical properties or activity (hereinafter "electrical activity") within a patient's cardiac tissue. System 10 may include a catheter 100, which is one or more catheters configured to be introduced into a patient's cardiac chamber. Catheter 100 may include a functional assembly 150, which comprises an electrode 155, which is at least one or more electrodes. System 10 may include a console 200, which is configured to be operably attached to the catheter 100, for example, to record one or more signals from the functional assembly 150, to deliver energy (e.g., ablation energy) to the functional assembly 150, and / or to facilitate one or more other functions of System 10 as described herein.

[0056] Catheter 100 may comprise one or more catheters selected from a group consisting of mapping catheters, ablation catheters, delivery catheters such as right atrial access catheters, catheters configured to be placed in the coronary sinus (e.g., CS catheters), and combinations thereof. One or more catheters 100 of system 10 may be configured to perform cardiac mapping and ablation, which may include creating a three-dimensional (3D) map of one or more cavities of the patient's heart and ablating cardiac tissue such as tissue determined (e.g., by a clinician and / or automatically or semi-automatically by system 10) to be contributing to the patient's arrhythmia.

[0057] In some embodiments, the console 200 includes a navigation module 250 configured to provide one or more drive signals and / or record one or more signals, as described herein. The navigation module 250 may be configured to analyze the recorded signals to provide tracking (or, as herein, “navigation” or “localization”) of one or more catheters 100 and / or other components of the system 10 within a patient (e.g., to navigate a functional assembly 150 within a cardiac chamber). The navigation module 250 may be configured to perform one, two or more localization techniques, such as impedance-based localization, magnetic localization, and / or hybrid localization including both impedance-based and magnetic localization. Localization of one or more catheters or other devices inserted into a patient may be performed during a clinical procedure to determine the position and / or orientation (as herein, “position”) of at least a portion of the device (e.g., a functional assembly 150 of catheter 100). The navigation module 250 may include a magnetic navigation module 251 and / or an impedance navigation module 255, each configured to perform a magnetic navigation process and an impedance-based navigation process, respectively, as described herein. In some embodiments, the navigation module 250 includes a translation module 259 configured to integrate localization information determined by modules 251 and 255 to perform hybrid localization, as described herein. In some embodiments, the catheter 100 includes an illustrated coil 310, which is one or more magnetic navigation sensors. The coil 310 may be located as part of the functional assembly 150, on the shaft 110, and / or on another part of the catheter 100. The coil 310 may include one or more magnetic coils and / or other magnetic field response elements, which may be configured to generate one or more signals related to a magnetic field, as described herein.

[0058] In some embodiments, the console 200 includes a treatment module 270 that provides one or more electrical signals delivered to the patient via a functional assembly 150, the electrical signals being delivered to treat tissue. The console 200 may also include a diagnostic module 260 that records one or more signals (e.g., signals recorded via the functional assembly 150) for diagnosing the patient, for example, to map the patient's cardiac electrical pathways, as described herein. For example, the system 10 may be configured to perform contact and / or non-contact mapping of cardiac electrical pathways. In some embodiments, non-contact mapping (e.g., without contact with the heart wall while the electrodes 155 of the catheter 100 record electrical activity) provides improved accuracy (compared to, for example, contact mapping) for mapping cardiac electrical pathways, for example, while the heart is in atrial fibrillation. For example, non-contact mapping can provide simultaneous global mapping of a large portion (e.g., the entire) of the cardiac chambers (e.g., the electrical activity of the entire chamber can be mapped almost instantaneously). This simultaneous mapping of the entire cavity can provide improved accuracy when mapping complex and irregular cardiac electrical activity, for example, when the heart is experiencing atrial fibrillation.

[0059] In some embodiments, the console 200 includes an anatomy module 280 configured to provide a 3D model of at least a portion of the patient's heart, such as a digital anatomical model, e.g., the cavities of the heart mapped by the system 10, as described herein. The anatomy module 280 may be configured to import 3D models, such as 3D models generated from imaging devices, e.g., MRI and / or CT imaging devices. Alternatively or additionally, the anatomy module 280 may be configured to provide signals and / or collect data from one or more devices of the system 10 (e.g., catheter 100) to generate a 3D anatomical model. For example, catheter 100 may comprise one or more ultrasound transducers configured to transmit and receive ultrasound signals, and the anatomy module 280 may be configured to generate a 3D model of the anatomical structure based on the ultrasound data. In some embodiments, the system 10 is configured to localize one or more devices relative to the anatomical model (e.g., the anatomical model is similarly localized to a 3D coordinate system established by the system 10, e.g., as described herein). One or more localized devices may be displayed relative to the anatomical model, for example, on the display of system 10, as described herein.

[0060] System 10 in Figure 1 may include components similar to those of System 10 described with reference to Figure 1A and / or other drawings described herein, and otherwise may have a similar configuration and arrangement.

[0061] System 10 may include one or more functional elements, for example, the illustrated functional element 99. One or more components of System 10, for example, the catheter 100 and / or console 200, may each include a functional element 99, for example, the illustrated functional elements 199 and / or 299 each comprise a functional element 99. Individually or collectively, the various functional elements described herein may be referred to individually or collectively as “functional element 99”.

[0062] Referring further to Figure 1A, a block diagram of another embodiment of the diagnostic mapping system consistent with the concept of the present invention is shown. In some embodiments, one or more components of system 10 in Figure 1A have a similar configuration and arrangement to similar components described herein with reference to Figure 1.

[0063] System 10 may include a processing unit 50, which is one or more data processing modules configured to perform and / or facilitate one or more of the functions of System 10 described herein. For example, the processing unit 50 can perform and / or facilitate one or more processes, data acquisition, data analysis, data transfer, signal processing functions, energy delivery, monitoring of one or more patient parameters, and / or other functions of System 10 (hereinafter referred to as "System 10 functions" or "System functions"). The processing unit 50 may comprise one or more electronic elements, electronic assemblies, and / or other electronic components, such as a microprocessor, microcontroller, state machine, memory storage component, analog-to-digital converter, rectifier circuit, amplifier, filter, and / or other signal conditioner, sensor interface circuit, transducer interface circuit, and components selected from the group consisting of one, two or more combinations thereof. For example, the processing unit 50 may include at least one processor and at least one memory storage component, such as the processor 51 and memory 52 shown herein, respectively. Memory 52 may be coupled to the processor 51 and may store illustrated instructions 53, which are a set of one or more computer instructions. Instructions 53 may include instructions used by the processor 51 to execute one or more algorithms of system 10. For example, system 10 may have illustrated algorithms 55, which are one or more algorithms executed by the processor 51. Additionally or alternatively, instructions 53 may include instructions for executing one or more applications of system 10, for example, illustrated application 56. Processing unit 50 may be configured to “execute” application 56, allowing application 56 to start, change, stop, and / or coordinate the execution of various functions of console 200 and / or system 10.In some embodiments, application 56 is configured to receive input from a user of system 10 (e.g., a clinician, nurse, or other operator of system 10) via, for example, a user interface (e.g., user interface 60 as described herein). In some embodiments, algorithm 55 may include one or more machine learning, neural network, and / or other artificial intelligence algorithms (hereinafter referred to as "AI algorithms"). All or some of the one or more processing units 50 may be integrated with one, two, or more of the various components of system 10, for example, a console 200, a server (e.g., server 80 as described herein), and / or other components of system 10.

[0064] System 10 may include one or more user interfaces, which are illustrated user interfaces 60. User interfaces 60 may provide information to and / or receive information from users of the system (e.g., clinicians and / or other users of System 10). User interfaces 60 may include one or more user input components and / or output components. For example, user interfaces 60 may include a user input device 61, which is a keyboard, mouse, touchscreen, and / or other human interface or other input component (e.g., as described herein). In some embodiments, user interfaces 60 may include a user output device 62, which is a speaker, indicator light, tactile transducer, and / or other human interface or other output component (e.g., as described herein). In some embodiments, the user output device 62 includes a video output component, for example, an illustrated display 63. The display 63 may include a touchscreen display, for example, when the user input device 61 and user output device 62 collectively comprise the display 63. In some embodiments, the processing unit 50 is configured to provide an interactive graphical interface, GUI 65, a graphical user interface provided by, for example, an application 56. The GUI 65 may be displayed via a display 63 (for example, displayed to a user of system 10). In some embodiments, the user interface 60 and / or GUI 65 include a virtual reality and / or augmented reality interface. One or more components of system 10 may comprise one or more parts of the user interface 60, for example, a catheter 100, a console 200, and / or other components of system 10 described herein.

[0065] System 10 may include a communication module 70, which is one or more communication modules. One or more devices of System 10 may comprise one or more parts of the communication module 70, e.g., a catheter 100, a console 200, and / or other components of System 10 as described herein. The communication module 70 may be configured to provide communication (e.g., transferring commands, delivery information, patient information, and / or other data) between two or more components of System 10, for example, via wired and / or wireless communication. For example, the communication module 70 may include a transceiver 71, which is one or more transmitters and / or receivers. The transceiver 71 may comprise wireless transceivers, e.g., Bluetooth transceivers, near-field communication (NFC) transceivers, Wi-Fi transceivers, cellular transceivers, satellite connection transceivers, and / or other short-range and / or long-range wireless transceivers. Wireless connections may include short-range wireless connections, e.g., NFC connections and / or Bluetooth Low Energy (BLE) connections. In some embodiments, the communication module 70 is configured to transfer data via acoustic signals, for example, acoustic signals outside the user's hearing range. In some embodiments, the communication module 70 is configured to communicate via one or more wired and / or wireless networks, for example, the illustrated network 75. Network 75 may include wireless networks, for example, cellular networks, LANs, WANs, VPNs, the Internet, and / or other wireless networks connecting two or more devices. In some embodiments, network 75 comprises a wired network, and / or a network including wired and wireless devices.

[0066] The communication module 70 may be configured to transfer data between at least a first component of the system 10 and at least a second component of the system 10, as described herein. In some embodiments, the first component of the system 10 comprises a catheter 100. The second component may comprise another component of the system 10, for example, a console 200.

[0067] In some embodiments, System 10 includes one or more illustrated servers 80 which may be configured to provide data storage and / or data processing to the provider of System 10 (e.g., the manufacturer and / or distributor of System 10), and / or to users or patients of System 10. As used herein, data processing may refer to receiving data, processing data, transmitting data (e.g., transmitting the results of data processing), and / or storing data. Server 80 may comprise one or more processing units 50. Additionally or alternatively, Server 80 may include one or more data storage units for storing illustrated data 85 which is data collected by System 10. In some embodiments, Server 80 may be configured to process data from various users of System 10, for example, if the provider of System 10 maintains one or more servers 80 configured to process data for each (and / or subset) of users of System 10 (e.g., each of the clinicians, patients, and / or other users of System 10). Server 80 may include “offsite” servers (e.g., located remotely from the users of System 10), such as servers owned, maintained, and / or otherwise provided by the provider of System 10. Alternatively or additionally, Server 80 may include cloud-based servers.

[0068] In some embodiments, the catheter 100 includes at least a portion of the processing unit 50, at least a portion of the user interface 60, and / or at least a portion of the communication module 70, for example, the catheter 100 comprises the processing unit 105, the user interface 106, and / or the communication module 107, respectively as shown. In some embodiments, the console 200 includes at least a portion of the processing unit 50, at least a portion of the user interface 60, and / or at least a portion of the communication module 70, for example, the console 200 comprises the processing unit 205, the user interface 206, and / or the communication module 207, respectively as shown. In some embodiments, the processing unit 205 is configured to perform one or more functions of the navigation module 250, the diagnostic module 260, the treatment module 270, and / or the dissection module 280, as described herein. For example, the processing unit 205 may be configured to process data received from the catheter 100 by the navigation module 250 and / or the diagnostic module 260, such as localizing the device and / or mapping cardiac electrical activity, as described herein. The algorithm 55 may be executed by the processing unit 50 to perform one or more of the functions described with reference to the various modules of the console 200. The console 200 may be configured to facilitate interaction between the clinician and the system 10, for example, by providing an interface for planning, performing, and / or reviewing procedures. The display 63 of the user interface 60 may be coupled to the console 200 and may provide a visual output (e.g., GUI 65) for displaying real-time data, images, and / or other information required by the physician during a procedure. In some embodiments, the console 200 comprises two or more separate console units (e.g., two or more units, each having a housing enclosing various components described herein).For example, the console 200 may include a workstation, for example, a workstation with a user interface such as user interface 206, and a separate console (e.g., a separate unit operably mounted to the workstation unit) housing one or more modules such as navigation module 250, diagnostic module 260, procedure module 270, and / or dissection module 280. In some embodiments, the workstation unit of the console 200 includes a user device, such as a tablet or desktop computer, that provides an interface for controlling the separate unit of the console 200, for example, the separate unit comprising a signal generator and / or power generator, and / or various data acquisition modules (e.g., components of modules 250, 260, 270, and / or 280 as described herein). In some embodiments, two or more separate units of the console 200, and / or two or more other components of the system 10 (e.g., the console 200 and catheter 100) are connected via one or more cables, for example, cable 121 as described with reference to Figure 2 and elsewhere in this specification.

[0069] The catheter 100 may include an illustrated shaft 110, which is an elongated body extending from an illustrated handle 120, which is a user-controlled portion. The functional assembly 150 may be located on the distal portion of the shaft 110, for example, if the functional assembly 150 includes an expandable array located at the distal end of the shaft 110. One embodiment of the functional assembly 150 with an expandable array is described with reference to Figure 2 and elsewhere in this specification.

[0070] The functional assembly 150 may include an expandable array, for example, one or more flexible struts, the illustrated splines 151, for example, an expandable array of two, four, six, eight, ten, or twelve splines 151. The functional assembly 150 may include one or more flexible circuit portions, the illustrated flex circuits 152, for example, flex circuits 152 located on each side of each spline 151 (e.g., the side facing the center of the functional assembly 150, which is the "inside" of each spline, and the side facing away from the center of the functional assembly 150, which is the "outside" of each spline). Each flex circuit 152 may include one or more electrodes 155, for example, as described with reference to Figure 3 and elsewhere in this specification, electrodes 155 positioned on the inside flex circuit 152 are oriented toward the center of the functional assembly 150, and electrodes 155 positioned on the outside flex circuit 152 are oriented toward away from the center of the functional assembly 150.

[0071] The functional assembly 150 may comprise a high-density electrode 155 and / or a number of electrodes 155. For example, the functional assembly 150 may comprise at least four splines 151, for example, at least six, eight, ten, or twelve splines 151. Each spline 151 may comprise at least three electrodes 155 on each side (for example, inward and outward as described herein), for example, at least six, eight, ten, twelve, fourteen, or sixteen electrodes 155 on each side.

[0072] The spline 151 may include a material selected from the group consisting of nickel-titanium alloy, stainless steel, polyethyleneimine (PEI), polyimide, and combinations thereof. Each spline 151 may include a flexible member and / or an elastic member, e.g., an elastic ribbon (e.g., a flat sheet), e.g., a nickel-titanium (e.g., nitinol) ribbon. Each spline may include a length of at least 15 mm and / or no more than 35 mm. Each flex circuit 152 may be operably attached to a portion (e.g., a side) of the associated spline 151. For example, the flex circuit 152 may be attached to the spline 151 by lamination, bonding, and / or other means. The electrode 155 may include a material selected from the group consisting of gold, platinum, platinum-iridium, iridium oxide, PDOT conductive polymer, titanium nitride, graphene, precious metal alloys, and combinations thereof. In some embodiments, each electrode 155 includes a coating selected from the group consisting of, for example, a gold coating, a coating configured to reduce the input impedance of the electrode, a PDOT coating, an iridium oxide coating, a titanium nitride coating, an oxide coating, and combinations thereof. Each electrode 155 may have a thickness of at least 0.01 μm and / or 10 μm or less. Each electrode 155 has a thickness of at least 0.3 mm 2 and / or 5.0 mm 2 The following surface areas may be included.

[0073] Each electrode 155 of the functional assembly 150 may be operably attached to a portion of the flexible circuit 152, for example, to the electrical traces of the flexible circuit 152 which are operably (e.g., electrically) connectable to the console 200, via one or more electrical conductors (e.g., one or more wires or flexible circuits) and one or more connectors configured to operably attach the catheter 100 to the console 200, such as a cable 121 including connector 122, for example, as described with reference to Figure 2 and elsewhere in this specification. In some embodiments, the flexible circuit 152 includes one or more vias connecting one or more electrical components on various layers of the circuit. In some embodiments, one or more vias connecting the electrode 155 to the electrical traces of the flexible circuit 152 may include a coating, for example, gold or other coating.

[0074] As described herein, the catheter 100 may include one or more magnetic navigation sensors, for example, the illustrated coil 310. The coil 310 may be located in part of the functional assembly 150 to provide signals related to the position, orientation and / or geometric configuration of the functional assembly 150 (e.g., whether it is in an extended geometric configuration or a converged geometric configuration), as described herein. The coil 310 may include multi-degree-of-freedom sensors, for example, 3-degree-of-freedom, 4-degree-of-freedom, 5-degree-of-freedom, and / or 6-degree-of-freedom (DOF) sensors.

[0075] The console 200 may include a power supply 210 that provides power to various components of the console 200. In some embodiments, the power supply 210 is configured to provide patient isolation, for example, if the console 200 is configured to receive power from an outlet or other external power source and the power supply 210 includes a patient protection circuit configured to protect the patient from the external power source. This isolation can protect the patient from potential electrical hazards and ensure that the catheter 100 can operate safely within the patient's body.

[0076] The diagnostic module 260 may include an EGM assembly 261, which is a cardiac signal processing assembly. The EGM assembly 261 may be configured, for example, by mapping the patient's cardiac electrical pathways to receive and record signals from the electrodes 155 of the catheter 100 and process the recorded signals to diagnose and / or otherwise evaluate the patient.

[0077] The treatment module 270 may be configured to provide the catheter 100 with electrical energy (e.g., via one or more electrodes 155) to be delivered to the patient's tissue for ablation and / or other treatment. The treatment module 270 may include one or more signal generators, e.g., the illustrated signal generator 271, configured to generate electrical signals to be delivered to the tissue. The signal generator 271 may be configured to generate RF signals, e.g., signals configured to thermally ablate the tissue, and / or electroperforation signals, e.g., signals configured to reversibly and / or irreversibly electroperforate the tissue.

[0078] The magnetic navigation module 251 may include a magnetic signal generator 252, which is a signal generator that generates one or more magnetic drive signals, and / or a magnetic signal receiver 253, which is a signal receiver that receives and records signals from one or more magnetic sensors, such as the coils 310 of the catheter 100. The system 10 may include a magnetic field generator 300 that receives drive signals from the magnetic signal generator 252 and generates one or more magnetic localization fields in the vicinity of the patient (for example, to generate a magnetic field surrounding at least the cardiac chambers into which the functional assembly 150 is to be inserted). Each coil 310 may generate a signal (for example, a signal recorded by the magnetic signal receiver 253) related to the position of the coil in the magnetic localization field generated by the magnetic field generator 300. For example, each coil 310 may receive a magnetic signal (for example, sense the magnetic field generated by the magnetic field generator 300) and generate an electrical signal based on the received magnetic signal.

[0079] The impedance navigation module 255 may include an impedance signal generator 256, which is a signal generator that generates one or more electrically driven signals, and / or an impedance signal receiver 257, which is a signal receiver that receives and records signals from one or more electrodes, such as electrodes 155 of the functional assembly 150. The system 10 may include patch electrodes 40, which are one or more external patient electrodes. The impedance signal generator 256 may be configured to deliver the generated electrically driven signals between two or more sets of patch electrodes 40, for example, to establish a multi-axis impedance localization field within the patient. In some embodiments, the multi-axis impedance localization field may be configured as described with reference to Figures 6A and / or 6B of this specification. In some embodiments, the signals provided by the impedance signal generator 256 include different frequencies, for example, signals including different frequencies are delivered between different pairs of patch electrodes 40, resulting in each axis of the multi-axis impedance localization field having a signal with a different frequency (e.g., current flowing through the patient between the patch pairs).

[0080] In some embodiments, the navigation module 250 defines a 3D coordinate system surrounding the patient, from which various devices of the system 10 can be localized. A magnetically localized field generated by the magnetic field generator 300 can be correlated to the 3D coordinate system, so that the position of a magnetic sensor determined relative to the magnetically localized field via magnetic localization can be correlated to a position in the 3D coordinate system. Additionally or alternatively, a multi-axis impedance localized field generated by a signal delivered between patch electrodes 40 may also be correlated to the 3D coordinate system, so that the position of an electrode determined relative to the impedance localized field via impedance-based localization can be correlated to a position in the 3D coordinate system. In some embodiments, a first transformation matrix (hereinafter referred to as the “magnetic transformation matrix”) is used by the transformation module 259 of the navigation module 250 to convert position data determined by magnetic localization into position data relative to the 3D coordinate system. Additionally or alternatively, a second transformation matrix (referred to herein as the “impedance transformation matrix”) may be used by the transformation module 259 of the navigation module 250 to transform the position data determined by impedance-based localization into position data relative to a 3D coordinate system, as described herein.

[0081] As described herein, at least a portion of the catheter 100, for example, a functional assembly 150 comprising one or more coils 310 and / or electrodes 155, may be inserted into a patient, and a navigation module 250 may be configured to localize the inserted portion of the catheter 100 within the patient. The navigation module 250 may establish a 3D coordinate system for localizing the catheter 100 within the patient. In some embodiments, a magnetic signal receiver 253 is configured to record one or more signals from one or more coils 310 of the catheter 100, the signals relating to the position of the coils 310 in a magnetic field generated by a magnetic field generator 300. A transformation module 259 may be configured to localize the coils 310 in a 3D coordinate system based on the signals recorded by the magnetic signal receiver 253 (for example, by establishing a magnetic transformation matrix as described herein). The impedance signal receiver 257 may be configured to record one or more signals from one or more electrodes 155 of the catheter 100, as described herein, the signals relating to the position of the electrode 155 in an electric field generated by the signal provided to the patch electrode 40 by the impedance signal generator 256. In some embodiments, the signals recorded by the impedance signal receiver 257 include phase values, magnitude values, and / or both relating to the multi-axis impedance field described herein. In some embodiments, the patch electrode 40 includes one or more magnetic sensors, such as the illustrated coil 45, a sensor configured to generate a signal relating to the position of the patch electrode 40 in a 3D coordinate system based on a magnetic localization signal, so that the patch electrode 40 can be localized in a 3D coordinate system, as described herein.

[0082] One or more coils 310 and electrodes 155 of catheter 100 may form a reference pair, and the physical relationships between the elements of the reference pair have known physical spatial relationships. The conversion module 259 may be configured to establish an impedance transformation matrix based on the known relationships of the reference pair, localization data of the coils 310 of the reference pair, and signals recorded from the electrodes 155 of the reference pair by the impedance signal receiver 257. In some embodiments, the impedance signal receiver 257 is configured to record signals from one or more electrodes 155 that are not paired with the coils 310 (e.g., unpaired electrodes 155 of a catheter containing one or more reference pairs, and / or electrodes 155 of another catheter 100 that does not have any coils 310). The conversion module 259 may be configured to localize one or more electrodes 155 in a 3D coordinate system based on the signals recorded by the impedance signal receiver 257 and the impedance transformation matrix.

[0083] In some embodiments, the conversion module 259 is configured to calibrate the magnetic conversion matrix and / or the impedance conversion matrix (referred herein individually or collectively as “conversion matrices”). The conversion module 259 may be configured to calibrate the conversion matrices based on fitting the localized positions of one or more elements (e.g., the coil 310 and / or the electrode 155) to known physical spatial relationships of the elements of the catheter 100 (e.g., based on a known model of the catheter 100).

[0084] In some embodiments, one or more magnetic sensors (e.g., coils 45) may be attached to the patient (e.g., positioned on the patient's skin), and signals from these sensors may be used by the system 10 to compensate for the movement of the patient's body during the procedure, e.g., movement relative to the magnetic field generator 300. For example, two or more magnetic sensors (e.g., a patch electrode 40 with coils 45) may be attached to the patient. These sensors may be positioned in the same location as the patch electrode 40 (e.g., coils 45 integrated with the patch electrode 40), and / or may be positioned at other locations on the body separate from the patch electrode 40 (e.g., a non-electrode patient patch with coils 45). Signals recorded from the coils 45 may be used to track the movement of the patient's torso relative to a 3D coordinate system and may provide information to an algorithm (e.g., algorithm 55) that compensates for the movement of undesirable artifact components imposed on the navigation of one or more catheters within the body. The position and / or orientation of the coils 45 may be recorded at the start of the procedure for reference. During the procedure, the current position and / or orientation of the coil 45 can be used to construct a mathematical transformation. The transformation can be linear or nonlinear, and its inverse transformation can be used to remove the body motion component from the magnetic-based and impedance-based catheter localization information. This method of compensating for body motion can be applied to the navigation of one or more catheters or treatment or diagnostic devices of a system 10 localized within the body. Linear transformations can be any of the following: "identity" (no motion), "translation" (movement in space without rotation), "rotation" (change in orientation in space), "scale" (change in volume), "shear" (sliding and stretching motion along one direction), or any combination thereof. In some embodiments, the linear transformation simply corresponds to rigid body motion (a combination of "translation" and "rotation"). More precise nonlinear transformations can also be constructed when three or more coils 45 are used. In some embodiments, compensation for respiratory motion can be performed using the "scale" transformation type. Linear affine transformations for different motion types are provided by the following equations.

number

number

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[0085] Referring here to Figure 2, a side view of one embodiment of a catheter including a handle and a functional assembly consistent with the concept of the present invention is shown. The catheter 100 and / or other components of the system 10 shown in Figure 2 may have a similar configuration and arrangement to similar components described with reference to Figure 1 and elsewhere in this specification. The catheter 100 may include a handle 120 which is a user control portion. The shaft 110 may extend distally from the handle 120, and the functional assembly 150 is positioned near the illustrated distal portion 118 which is the distal portion of the shaft 110. The catheter 100 may include one or more interconnectors, a cable 121 which includes one or more conduits such as electrical, fluid transport, optical, mechanical linkages and / or other conduits configured to operably attach the catheter 100 to the console 200 and / or other components of the system 10. The cable 121 may include a connector 122 that is detachably attached to a component of the system 10 (e.g., the console 200) and forms one or more connections, e.g., one or more electrical, fluid, optical, mechanical, and / or other operable connections between the catheter 100 and the connected component. In some embodiments, the cable 121 provides a fluid connection between the console 200 and the catheter 100, for example, the catheter 100 is configured to provide irrigation through one or more lumens extending through the shaft 110 to one or more irrigation ports near a functional assembly 150, the irrigation ports being known to those skilled in the art, although not shown.

[0086] The handle 120 may include one or more user control units (e.g., one or more control units of the user interface 60, e.g., user input device 61). For example, the handle 120 may include one or more mechanical control units, e.g., steering control unit 125a and / or deployment control unit 125b, respectively, which enable the user to mechanically manipulate a portion of the catheter 100. The steering control unit 125a may be operably mounted to one or more steering cables (not shown) arranged to manipulate the articular movement of the distal portion 118 of the shaft 110. The deployment control unit 125b may be operably mounted to one or more linkages (not shown, but described herein) arranged to manipulate the geometric shape of the functional assembly 150, for example, to transition the functional assembly 150 from a linear (compressed) geometric shape to a radially expanded geometric shape (e.g., if the functional assembly 150 has an expandable basket arrangement, as described herein). Additionally or alternatively, the handle 120 may include an illustrated user input 126, which is one or more user input control units (e.g., a user input configured to provide input signals to the console 200). User input 126 may be configured to provide input signals, e.g., signals configured to start and / or stop processes of the system 10 described herein, for, for example, recording data (e.g., during a cardiac mapping process) and / or delivering energy (e.g., during an ablation process). The handle 120 may include one or more outputs (e.g., one or more outputs of the user interface 60, e.g., a user output device 62). For example, the handle 120 may include an output 127, an output device having, e.g., a visual indicator, an audible indicator, a tactile indicator, and / or other output devices, as described herein.

[0087] Referring here to Figure 3, a perspective view of the distal portion of one embodiment of a catheter including a basket-like functional assembly consistent with the concept of the present invention is shown. The catheter 100 and / or other components of the system 10 shown in Figure 3 may have similar configurations and arrangements as similar components described with reference to Figure 1 and elsewhere in this specification. In the embodiment of Figure 3, the functional assembly 150 comprises a basket-like array shown in an extended geometric shape. Figure 3 shows the distal portion of the catheter 100, including the distal portion 118 of the shaft 110 and the functional assembly 150. The shaft 110 may include one or more lumens extending therein, e.g., a lumen 115 extending proximal from the distal end 119 through the shaft 110. The distal portion 118 of the shaft 110 may include a coupler housing 114, which is a coupling mechanism connecting the functional assembly 150 to the shaft 110, as described herein. The catheter 100 may include a control assembly 160 configured and positioned to control the geometric shape of the functional assembly 150. The control assembly 160 may include one or more linkages, for example, the illustrated puller tube 161, and a housing 162 which is a distal hub assembly attached to and / or forming the distal portion of the functional assembly 150. In some embodiments, for example as shown in Figure 3, the proximal portion of each spline 151 is fixedly attached to the coupler housing 114, and the distal portion of each spline 151 is fixedly attached to the housing 162. The puller tube 161 may be advanced and / or retracted through the lumen 115 to adjust the distance between the housing 162 and the distal end 119 of the shaft 110, thereby adjusting the geometric shape of the functional assembly 150 (for example, by straightening and / or bending each spline 151 to transition between a linear geometric shape and an extended geometric shape). The puller tube 161 can be operably mounted to a user control unit, for example, the deployment control unit 125b described with reference to Figure 2 of this specification.Alternatively or additionally, the puller tube 161 may be operably mounted to a linear actuator or other electromechanical actuator, for example, if the catheter 100 is configured to be automatically and / or semi-automatically controlled (e.g., robotically controlled). The functional assembly 150 is shown in its expanded geometric shape in Figure 3. Figure 4, as described herein, shows the functional assembly 150 in its linear geometric shape. The functional assembly 150 may be configured to expand to a diameter of at least 12 mm, e.g., at least 16 mm, and / or 35 mm or less, e.g., 24 mm or less.

[0088] The functional assembly 150 may include a distal surface 159, as shown. In some embodiments, the distal surface 159 includes the most distal end of the catheter 100, for example, when none of the shaft 110, puller tube 161, and / or housing 162 extend beyond the distal surface 159 (e.g., the catheter 100 is a “noseless” catheter). For example, the distal end of the spline 151 may be adjacent to the distal surface 159, as shown.

[0089] The catheter 100 may include one or more coils 310 configured to enable magnetic localization of the functional assembly 150 and / or other parts of the catheter 100, as described herein. In some embodiments, the catheter 100 includes, as illustrated, at least a first coil 310a located near the coupler housing 114 (for example, in a fixed position relative to the distal end 119 of the shaft 110) and a second coil 310b located on or within the housing 162. The system 10 may be configured to localize each of the coils 310a, b and to determine the deployed state of the functional assembly 150 based on a determined distance between the coils.

[0090] Each spline 151 may include (for example, be positioned on) a set of electrodes 155a, which are one or more “outward” electrodes (electrodes facing away from the center of the functional assembly 150), and / or a set of electrodes 155b, which are one or more “inward” electrodes (electrodes facing toward the center of the functional assembly 150), each as illustrated. Each electrode 155 may be electrically coupled to one or more conduits, for example, one or more traces of a circuit assembly, for example, a flexible circuit 152 as described herein. In some embodiments, the flexible circuit 152 comprises a flexible circuit board structure, for example, a flexible board having electrical traces connecting various components of the circuit (for example, electrodes 155 located thereon). Alternatively or additionally, the flexible circuit 152 may include one or more wires electrically connected to various electrical components of the functional assembly 150 (and / or catheter 100), for example, individual wires without a board such as a “circuit board”. The functional assembly 150 may comprise one or more individual flex circuits, and each flex circuit 152 may comprise all or some of the individual flex circuits, for example, if a single flex circuit comprises two or more parts, each of which is positioned relative to a part of the functional assembly 150. The various individual flex circuits may be interconnected by one or more connectors, wires, or other electrical conduits.

[0091] Each spline 151 may include a flex circuit 152a positioned outside the spline and / or a flex circuit 152b positioned inside the spline (for example, may be positioned on it) (for example, as shown, each outward electrode 155a is positioned on the flex circuit 152a and each inward electrode 155b is positioned on the flex circuit 152b). In some embodiments, each flex circuit 152a and 152b of each spline 151 comprises a single separate flex circuit that is "folded" such that the first part of the flex circuit comprises an outward flex circuit 152a and the second part of the flex circuit comprises an inward flex circuit 152b. Alternatively or additionally, each of the flex circuits 152a,b of each spline 151 may comprise separate flex circuits, for example, separate flex circuits interconnected as described herein. In some embodiments, the functional assembly 150 comprises a first individual flex circuit having each outward-facing flex circuit 152a (e.g., a single individual flex circuit having a plurality of elongated sections, each positioned along the outside of the associated spline 151), and / or a second individual flex circuit having each inward-facing flex circuit 152b (e.g., a single individual flex circuit having a plurality of elongated sections, each positioned along the inside of the associated spline 151). In some embodiments, the single individual flex circuit comprises a plurality of elongated sections, each having a flex circuit 152a or 152b, and the single flex circuit is configured to be folded and / or otherwise operated (e.g., in a manufacturing process) to align with the inside and / or outside of each spline 151.

[0092] Referring here to Figure 4, a side view of the distal portion of one embodiment of a catheter including a basket-like functional assembly consistent with the concept of the present invention is shown. The catheter 100 and / or other components of the system 10 shown in Figure 4 may have similar configurations and arrangements as similar components described with reference to Figure 1 and elsewhere in this specification. In the embodiment of Figure 4, the functional assembly 150 comprises a basket-like array shown in a convergent ("linear") geometric shape. Figure 4 shows the functional assembly 150 extending from the distal end 119 of the shaft 110. The distal portion 118 of the shaft 110 includes a coupler housing 114 as described herein. The puller tube 161 is shown in an extended position (extending distally from the shaft 110), with the housing 162 of the control assembly 160 positioned away from the coupler housing 114, and the spline 151 extending in the illustrated linear geometric shape. Coils 310a,b are shown located within the coupler housing 114 and housing 162, respectively, as described herein. In the illustrated geometric shape, the distance between coils 310a and 310b is greater than the relative distance between coils in the extended geometric shape of the functional assembly 150 shown in Figure 3. Each spline 151 may include a flex circuit 152 (illustrated outward flex circuit 152a) and / or an electrode 155 (illustrated outward electrode 155a). The distal surface 159 of the functional assembly 150 includes the most distal portion of the catheter 100, as illustrated and described herein.

[0093] Referring further to Figure 4A, a cross-sectional view of the functional assembly of Figure 3 is shown, consistent with the concept of the present invention. Coil 310a is shown positioned within the coupler housing 114. Coil 310a may include a hollow structure, as shown, so that the puller tube 161 can slidably extend through coil 310a. Coil 310b is shown positioned within the housing 162. The distal end of each spline 151 may be fixedly attached to the distal end of the housing 162, as shown, to form a distal surface 159. The proximal end of each spline 151 may extend within the coupler housing 114 and be fixedly attached within the coupler housing 114, as shown.

[0094] Referring here to Figures 5A and 5B, side views are shown of various embodiments of a spline of a functional assembly, including staggered and aligned electrodes, respectively, consistent with the concept of the present invention. The spline 151 and / or other components of system 10 shown in Figures 5A and 5B may have similar configurations and arrangements as similar components described with reference to Figure 1 and elsewhere in this specification. Figures 5A and 5B show the outward-facing sides of various embodiments of the spline 151, with a flex circuit 152a (illustrated) positioned on the outward-facing surface and a flex circuit 152b (not shown) positioned on the inward-facing surface, as described herein. The outward-facing electrode 155a is shown by a solid line, and the inward-facing electrode 155b (located on the opposite side of the shown side of the spline 151) is shown by a dashed line.

[0095] In some embodiments, as shown in Figure 5A, the outward-facing electrode 155a may be axially offset from the inward-facing electrode 155b (e.g., along the length of the spline 151). Alternatively, as shown in Figure 5B, the outward-facing electrode 155a may be axially aligned with the inward-facing electrode 155b (e.g., along the length of the spline 151). In some embodiments, the alignment of electrodes 155a,b differs between two or more splines 151 of the functional assembly 150. In some embodiments, the number of outward-facing electrodes 155a matches and / or differs from the number of inward-facing electrodes 155b.

[0096] Referring here to Figures 6A and 6B, anatomical diagrams are shown illustrating embodiments of patch electrode arrangement configurations consistent with the concept of the present invention. The patch electrodes 40 and / or other components of the system 10 shown in Figures 6A and 6B may have similar configurations and arrangements as similar components described with reference to Figure 1 and elsewhere in this specification. The system 10 may include one or more sets (e.g., “pairs”) of two or more patch electrodes 40, for example, electrodes 41a, b which are a first pair, electrodes 42a, b which are a second pair, and / or electrodes 43a, b which are a third pair. An impedance signal generator 256 of an impedance navigation module 255, which is not shown but is described herein, may be configured to provide an electrical signal between each electrode of a pair of patch electrodes 40, for example, to generate an electrical impedance field between the electrodes. Signals containing different electrical characteristics (e.g., signal frequencies) may be provided between different pairs of patch electrodes 40, for example, to create a multi-axis impedance localized field. The impedance navigation module 255 can receive and process signals from one or more electrodes positioned on a patient implantation device (e.g., electrodes 155 of catheter 100), and these signals are related to a multi-axis impedance localization field and processed to localize the patient implantation device.

[0097] The placement and alignment of each pair of patch electrodes 40 may be configured based on procedural needs and / or the patient's physique (e.g., the patient's body size and shape). Figures 6A and 6B show two non-limiting embodiments of the placement configuration of the patch electrodes 40. Figure 6A shows a pair of patient patch electrodes 41a, b positioned in the center of the patient's upper chest and lower back, respectively, defining the first axis of the impedance field. A pair of patch electrodes 42a, b are shown positioned in the lower right of the front of the patient's torso and the upper left of the back, respectively, defining the second axis of the impedance field. A pair of electrodes 43a, b are shown positioned in the lower left of the front of the patient's torso and the upper right of the back, respectively, defining the third axis of the impedance field. Figure 6B shows a pair of patch electrodes 41a, b similarly positioned in the center of the patient's upper chest and lower back, respectively, defining the first axis of the impedance field. The patch electrode pair 42a,b is positioned and shown at the center of the patient's lower torso and upper back, respectively, defining a second axis of the impedance field. The patch electrode pair 43a,b is positioned and shown on the right and left sides of the patient's torso, respectively, defining a third axis of the impedance field. In some embodiments, the patch electrode 40 is positioned and / or the signal provided is configured such that the physical location of zero amplitude of the composite impedance field (e.g., null point) is close to the patient's heart but outside the region of interest (e.g., close to but outside the cardiac chambers), for example, avoiding a null point within the region of interest (e.g., a location where the localized signal contains zero amplitude). Alternatively or additionally, the physical locations of zero amplitude of the field on one or more axes may be configured away from the patient's heart.

[0098] Referring here to Figures 7A to 7D, perspective views of a catheter having various embodiments of a functional assembly including electrodes and magnetic sensors, consistent with the concept of the present invention. The catheter 100 and / or other components of the system 10 shown in Figures 7A to 7D may have similar configurations and arrangements as similar components described with reference to Figure 1 and elsewhere in this specification. Figures 7A to 7D show various embodiments of the catheter 100, including a shaft 110 and a functional assembly 150, which includes one or more electrodes 155 and / or coils 310. Figure 7A shows a linear embodiment of the catheter 100. Figures 7B to 7D show various embodiments of an expandable functional assembly 150.

[0099] Figure 7A shows one embodiment of a catheter 100 having a functional assembly 150 positioned at the distal portion of the shaft 110. The electrode 155 may include a ring electrode and / or a tip electrode positioned at the distal portion of the shaft 110, as shown. The coil 310 may be positioned within the shaft 110 in close proximity to the functional assembly 150.

[0100] Figure 7B shows one embodiment of a catheter 100 having a functional assembly 150 comprising an expandable basket array of electrodes 155. The catheter 100 includes a puller tube 161 configured to advance and / or retract from a shaft 110 to converge and / or expand the functional assembly 150, respectively. One or more electrodes 155 and / or coils 310 can be positioned on the puller tube 161 as shown.

[0101] Figures 7C and 7D show an embodiment of the catheter 100 having a functional assembly 150 with an expandable balloon on which an array of electrodes 155 is positioned. One or more coils 310 may be positioned within the distal portion of the shaft 110 and / or within the functional assembly 150.

[0102] Referring here to Figure 8, a flowchart of a method for localizing a catheter is shown, consistent with the concept of the present invention. Method 1000 in Figure 8 can be carried out using components of System 10 described with reference to Figure 1 and elsewhere in this specification. Method 1000 includes a hybrid navigation method comprising establishing an impedance transformation matrix, calibrating the impedance transformation matrix, and using the impedance transformation matrix to localize one or more devices without magnetic sensors to a magnetic localization field and / or 3D coordinate system established by the navigation module 250 described herein. In some embodiments, the magnetic localization field includes a relatively uniform and / or relatively consistent magnetic field, including a direct correlation to the 3D coordinate system established by the navigation module 250. The multi-axis impedance localization field may include an impedance field that changes across different parts of the patient and / or a field that changes over time, the field of which changes over time being based, for example, on the patient's movement, respiration, and / or other perturbations that can change the field (spatially and / or temporally) and cause non-uniform localization of one or more electrodes. In step 1010 of Method 1000, the transformation module 259 may be configured to compute an impedance transformation matrix configured to translate impedance-based localization data into positions in a 3D coordinate system, the impedance transformation matrix configured to compensate for non-uniformity of the multi-axis impedance localization field based on impedance-based and magnetic localization data recorded from one or more “reference pairs” of electrodes 155 and coils 310. In some embodiments, the system 10 is configured to compute data provided as if recorded from one or more “virtual electrodes” 155 and / or “virtual coils” 310. The virtual electrode may provide impedance-based localized data calculated by the system 10 based on impedance-based data recorded from one or more physical electrodes 155 of the catheter 100, and provided as if it were recorded from the position of the virtual electrode.The virtual coil may provide magnetic localization data calculated by the system 10 based on data recorded from one or more physical coils 310 of the catheter 100, and provided as if recorded from the virtual coil. The reference pair of electrodes 155 and coils 310 may include physical and / or virtual electrodes and / or coils.

[0103] In some embodiments, the coil 310 and the electrode 155 (e.g., a physical and / or virtual coil and / or electrode) form a reference pair when the distance between the two elements is fixed. In some embodiments, the portion of the catheter 100 between the elements of the reference pair is rigid, or the portion may be configured to articulate (e.g., bend) in a known and / or predictable manner. Magnetic navigation information recorded from the coil 310 of the reference pair, and impedance-based navigation information recorded from the corresponding electrode 155 of the reference pair, along with the known physical relationship between the coil and the electrode, are processed by the console 200 (e.g., by the transformation module 259 of the navigation module 250) to calculate one or more impedance transformation matrices that correlate the impedance navigation system to a magnetic navigation system (e.g., and a 3D coordinate system).

[0104] The impedance transformation matrix can be calculated based on the localized position of each coil 310 in the 3D coordinate system, the known physical relationship between the coil 310 and the reference pair of electrodes 155, and impedance-based localization data recorded from each electrode 155 (e.g., based on data recorded from one or more reference pairs as described herein). Using the impedance transformation matrix, the impedance-based localization information of other electrodes 155 (e.g., electrodes 155 not referenced with the physical coil 310 and / or virtual coil, as described with reference to step 1050) can be transformed into positional information in the 3D coordinate system.

[0105] In step 1020, the navigation module 250 may be configured to determine whether the catheter 100 includes a catheter having a known physical configuration (e.g., the physical configuration of the coils 310 and electrodes 155 of the catheter 100). For example, the system 10 may be configured to identify the configuration of the catheter 100 based on information provided by a clinician (e.g., the clinician may indicate the configuration of the catheter 100 being used), and / or by electronic and / or other automatic and / or semi-automatic identification of the catheter 100 (e.g., if the catheter 100 includes an RFID or other identifier configured to provide configuration information to the system 10). In some embodiments, the navigation module 250 is configured to identify the configuration of the catheter 100 based on recorded localization information of one or more coils 310 of the catheter 100. For example, the navigation module 250 may include a library of various catheter model templates, each template containing information related to the physical configuration of each catheter (e.g., the physical configuration of the structure of each catheter, and / or the physical relationship between the coils 310 and electrodes 155 of each catheter). If a predetermined standard catheter model is identified by the navigation module 250 based on the determined position of the localized magnetic coil 310 (e.g., from a library of catheter model templates), the template may be used to refine the impedance transformation matrix and the position information of the electrode 155 calculated based on the impedance-based localization information of the electrode 155, as described with reference to steps 1030 and 1040. If no known catheter model template is identified, method 1000 proceeds to step 1050, which is described below. In step 1030, the identified catheter model template may be fitted (e.g., scaled) based on the localized position of the coil 310 of the catheter 100. In some embodiments, the catheter model template is derived from a formula based on the position of the coil 310, as well as the physically constrained separation distance and orientation of the electrode.For example, the splines and / or other linear arrangements of electrodes can be fitted by offset, rotation, least squares, bilinear, bicubic, Bézier, and / or other fitting formulas. Alternatively or additionally, the catheter model template may be determined from a lookup table containing a set of predefined physical measurements taken from the catheter when the catheter is set to various deployment levels (e.g., in 1%, 10%, or 25% deployment steps from fully converged to fully open), and / or to different shapes defined by a “phantom curve or surface” enclosing the splines and / or other configurations of electrodes distributed on the catheter. Once the catheter model template is fitted (e.g., scaled) to the catheter 100 which is localized based on magnetic localization information from the coil 310, the positional information converted from the impedance-based localization information of the electrodes 155 of the catheter 100 can be compared to the catheter model template. In step 1040, the difference between the fitted electrode position and the calculated electrode position is then used to calibrate the impedance transformation matrix and / or adjust the position information of the electrode 155 of the catheter 100.

[0106] In step 1050, impedance measurements from the electrode 155 of the catheter 100 (e.g., catheter 100 with or without coil 310) are transformed using an impedance transformation matrix so that the electrode 155 can be localized in a 3D coordinate system. Additionally or alternatively, one or more catheters 100 having one or more coils 310 can be localized in step 1050. If a catheter model was identified in step 1020, a calibrated impedance transformation matrix (e.g., the matrix calibrated in step 1040) may be used in step 1050. If a catheter model was not identified in step 1020, an initial (e.g., uncalibrated) impedance transformation matrix may be used in step 1050.

[0107] In some embodiments, to estimate the relationship between the multi-axis impedance localized field and the 3D space within the cardiac chambers (e.g., the 3D coordinate system generated by the navigation module 250), Method 1000 assumes "local" linearity of the impedance field. This is inspired by the fact that locally (i.e., in the vicinity of any point in space) the electric field is essentially uniform, and therefore the relationship between impedance values ​​and position can be assumed to be linear. Alternatively or additionally, Method 1000 may assume a nonlinear relationship between the multi-axis impedance localized field and the 3D space within the cardiac chambers (e.g., the 3D coordinate system generated by the navigation module 250). This is to address a changing impedance field (e.g., an impedance field near the cardiac wall, or an impedance field affected by an external source).

[0108] While the catheter 100, which includes one or more reference pairs of coils 310 and electrodes 155, is being manipulated in the cardiac chamber, magnetic localization data and impedance-based localization data from each of the reference pairs may be recorded and used to establish a dictionary, as described, for example, with reference to Figure 9 of this specification. In some embodiments, the impedance-based localization data may include recorded voltages and / or currents.

[0109] An example of a method for establishing a linear relationship between impedance-based localization information (e.g., recorded voltages) and 3D position based on data recorded from one or more reference pairs within a scanned volume (e.g., with respect to a 3D coordinate system) is given below. The scanned volume can be divided into a set of cubic voxel cells. In some embodiments, the side lengths of the voxel cells may include lengths of at least 2 mm and / or no more than 20 mm. The 3D positions of the reference pairs are converted to indexes in a voxel grid by dividing by a predetermined grid size for each axis (x, y, z). The grid size may be uniform across different axes, and / or voxels may have different grid sizes for different axes. For example,

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[0110] Referring here to Figure 9, a flowchart of a method for updating a dictionary grid, consistent with the concept of the present invention, is shown. Method 2000 in Figure 9 can be carried out using components of System 10 described with reference to Figure 1 and elsewhere in this specification. In some embodiments, impedance-based localization information, magnetic-based localization information, and / or other localization information associated with one or more grid cells of a voxel grid, e.g., a voxel grid described with reference to Figure 8 of this specification, can be stored in a dictionary-type data structure. A dictionary data structure can be used to efficiently store information associated with various local grid cells. One embodiment of the implementation of the dictionary data structure is shown in Table 1. [Table 1]

[0111] Method 2000 in Figure 9 includes a method for updating a dictionary data structure. In step 2010, a new input is received by the navigation module 250 and includes data related to a reference point (e.g., within a voxel of a grid cell). The data may include magnetic localization data, impedance-based localization data, and / or other data recorded from recording elements of the catheter 100 (e.g., coil 310 and / or electrode 155). In step 2020, after the new input-related reference pair is observed, a “key” is generated by the navigation module 250 based on the position of the reference pair. In step 2030, the navigation module 250 determines whether the key has been previously added to the list of keys in the dictionary or whether the key is new to the dictionary. In step 2040, if the “key” is not in the dictionary, a “value” is initialized based on the magnetic-based localization data and impedance-based localization data of the input, and the pair {key, value} is registered in the dictionary. In step 2050, if the "key" is already in the dictionary, the corresponding "value" is updated based on the input's magnetic-based localization data and impedance-based localization data.

[0112] Referring here to Figure 10, a flowchart of a method for estimating electrode positions based on an impedance transformation matrix, consistent with the concept of the present invention, is shown. Method 3000 in Figure 10 can be carried out using components of System 10 described with reference to Figure 1 and elsewhere in this specification. In some embodiments, System 10 includes an algorithm (e.g., Algorithm 55 described herein), for example, a “z-loc” algorithm configured to estimate the positions of one or more electrodes (e.g., electrode 155) relative to a 3D coordinate system established by the navigation module 250 based on impedance-based localization data.

[0113] The z-loc algorithm may provide an initial impedance transformation matrix for estimating the position of each electrode 155 of the catheter 100 based on measured impedance values ​​recorded from each electrode 155 (e.g., impedance-based localization information). Method 3000 includes a method of the z-loc algorithm for estimating the position of each electrode. The z-loc algorithm may be performed to localize one or more impedance-based elements (e.g., electrodes 155) with respect to a 3D coordinate system defined by the navigation module 250, as described herein. The 3D coordinate system may be correlated with a magnetic-based navigation system, as also described herein. In step 3010, the z-loc algorithm receives an input containing impedance transformation matrix information, e.g., information stored in a dictionary data structure, as described with reference to Figures 8 and 9 and elsewhere herein. In step 3020, the z-loc algorithm receives an input containing magnetic localization information, e.g., information relating to the positions of one or more coils 310 (e.g., the localized positions of one or more coils 310 relative to a 3D coordinate system established by the navigation module 250). In step 3030, the z-loc algorithm determines one or more impedance transformation matrices, e.g., one or more scaling matrices described herein. The z-loc algorithm can determine impedance transformation matrices for one or more voxel grids surrounding each position of a coil 310 whose position has been input to the z-loc algorithm (e.g., via a lookup of previously calculated matrices and / or by calculating the matrices). For example, if a dictionary is provided, the z-loc algorithm can perform a lookup of the dictionary for existing impedance transformation matrices correlated to grid cells within a certain range of positions for each coil 310. In some embodiments, up to N voxel grid cells closest to the position of each coil 310 are selected from the search results, e.g., N is equal to 4, 6, 8, or 10. In step 3040, the z-loc algorithm receives an input containing impedance-based localization information (e.g., voltage data) from one or more electrodes 155.In step 3050, the positions of all electrodes relative to the 3D coordinate system established by the navigation module 250 can be calculated using an impedance transformation matrix (e.g., a specified scaling matrix) associated with the selected grid cells by solving a system of equations, for example, with reference to Figure 8 and as described elsewhere in this specification.

[0114] In some embodiments, the z-loc algorithm includes one or more biases and / or assumptions. For example, the z-loc algorithm may assume that each electrode 155 of catheter 100 and / or the center of catheter 100 (e.g., the center of the functional assembly 150 of catheter 100) lies within a uniformly distributed impedance field. Additionally or alternatively, the z-loc algorithm may assume that the impedance field of neighboring voxel grid cells does not change significantly compared to the impedance field at the catheter's location. These two assumptions are known to be true when the impedance-based localization field is uniform and are expected to be sufficiently good for slowly changing impedance-based localization fields. If the impedance-based localization field changes significantly over short distances, accuracy is expected to decrease, and in such cases, a finer grid may be used. Additionally or alternatively, the z-loc algorithm may assume that each electrode 155 of catheter 100 and / or the center of catheter 100 (e.g., the center of the functional assembly 150 of catheter 100) lies within a nonlinear field following a second-order or higher-order form.

[0115] Referring here to Figure 11, a flowchart is shown illustrating a method for estimating electrode positions using a hybrid algorithm consistent with the concept of the present invention. Method 4000 in Figure 11 can be carried out using components of System 10 as described with reference to Figure 1 and elsewhere in this specification. In some embodiments, System 10 comprises an "h-loc" algorithm configured to estimate the positions of one or more electrodes (e.g., electrodes 155) relative to a 3D coordinate system established by the navigation module 250, based on an algorithm (e.g., algorithm 55 as described herein), for example, impedance-based localization data, magnetic localization data, and / or a known catheter configuration. The h-loc algorithm may provide an improved estimation of the positions of one or more electrodes 155 of the catheter 100 based on one or more initial estimations calculated by the z-loc algorithm as described with reference to Figure 10 and elsewhere in this specification.

[0116] In some embodiments, the catheter 100 includes a coil 310 as described herein, which is one or more magnetic sensors, and / or an electrode 155 as described herein, which is one or more electrical sensors. The catheter 100 may include two or more coils 310 positioned near a functional assembly 150, for example, with reference to Figure 1 and as described elsewhere in this specification. The two or more coils 310 of the catheter 100 may include similar or different configurations; for example, the two coils 310 of the catheter 100 with a basket-shaped functional assembly 150 may include two 5-DOF (degrees of freedom) coils 310, or one 5-DOF and one 6-DOF coil 310. In some embodiments, the coils 310 may include two or more coils or sets of coils, for example, two or more multi-degree-of-freedom coils, for example, two 6-DOF coils (for example, so that the coil 310 provides one or more redundant degrees of freedom, or up to 12 degrees of freedom). In some embodiments, the first coil 310 is positioned at the first end of the functional assembly 150, and the second coil 310 is positioned at the second end of the functional assembly 150, and the localization of the two coils can be analyzed to determine the length and / or orientation of the functional assembly 150, as described below.

[0117] In step 4010, the h-loc algorithm receives magnetic localization information related to two or more coils 310 of the catheter 100 (e.g., coils positioned at the first and second ends of the functional assembly 150). In step 4012, the h-loc algorithm may calculate the orientation and / or direction of the functional assembly 150 relative to the 3D coordinate system of the navigation module 250 based on the magnetic localization information. In step 4014, the h-loc algorithm receives estimated localization positions of one or more electrodes 155, such as estimates calculated by the z-loc algorithm as described herein.

[0118] In step 4020, the distance and / or angle between coils 310 is calculated based on magnetic localization information (e.g., the position of coil 310 relative to a 3D coordinate system established by the navigation module 250). In step 4030, this calculated distance and / or angle may be used to calculate the position of one or more electrodes 155 of catheter 100 in a local coordinate system based on a standard catheter model template. As described herein, the standard catheter model template may be mathematically modeled, physically measured from a physically existing catheter, or both.

[0119] In step 4040, the h-loc algorithm can calculate an arbitrary torsion (e.g., torsion angle) of the functional assembly 150. For example, if the coil 310 includes a multi-degree-of-freedom sensor, e.g., one, two, or more 5-DOF coils 310 and / or at least one 6-DOF coil 310 of the functional assembly 150, the torsion angle may be calculated from magnetic localization data recorded from the coil 310. Alternatively or additionally, if the functional assembly 150 comprises two 5-DOF coils 310 positioned at each end of the functional assembly 150, the optimal torsion angle may be estimated based on magnetic localization data recorded from the coil 310 and the estimated positions of the electrodes 155 calculated by the z-loc algorithm, as described herein. A schematic plot for obtaining this optimal torsion angle is shown and illustrated with reference to Figure 12 herein. The estimated positions of one or more electrodes 155 of the functional assembly 150 are transformed into a local coordinate system using the z-loc algorithm. In step 4050, the optimal twist angle can be calculated, for example, using a cost function.

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[0120] In some embodiments, the expected shape of the functional assembly 150 (e.g., the expected spatial relationships between the localized elements of the functional assembly 150) can be calculated based on an identified catheter model and the unfolded geometric shape of the functional assembly 150. The unfolded geometric shape can be calculated based on the length and / or angles of the functional assembly 150 (e.g., based on magnetic localization information from coils 310 positioned at both ends of the functional assembly 150), and / or based on the amount of mechanical pushing and / or pulling force applied by the catheter 100 deployment mechanism, e.g., the puller tube 161 of the catheter 100 (e.g., as described with reference to Figure 3 and elsewhere in this specification). In some embodiments, the pushing and / or pulling force applied by the catheter 100 deployment mechanism can be measured from the handle of the catheter 100 (e.g., handle 120). In some embodiments, the deployment force and the calculated length of the functional assembly 150 are used together to determine the expected shape of the functional assembly 150. The h-loc algorithm can estimate the torsion angle using the estimated positions of one or more electrodes 155 provided by the z-loc algorithm, and use the torsion angle to transform the calculated shape of the functional assembly 150. The h-loc algorithm can provide a more accurate estimate of the localized positions of the electrodes 155 relative to the 3D coordinate system of the navigation module 250, even though the estimation is based on the less accurate z-loc algorithm.

[0121] Referring here to Figure 12, a schematic plot is shown for obtaining the optimal torsion angle in a local coordinate system, consistent with the concept of the present invention. The illustrated schematic plot relates to finding the torsion angle of a functional assembly 150 of a catheter 100, including one or more coils 310 and / or electrodes 155, as described with reference to Figure 1 and elsewhere in this specification. The system 10 may be configured to localize the functional assembly 150 in a 3D coordinate system established by a navigation module 250, as described herein. Within a body cavity, the linearity of the impedance-based localization field may not be uniform throughout the body cavity, and therefore, using the assumption of local linearity, the estimation of the position of one or more electrodes 155 calculated by the z-loc algorithm may be less accurate than the refined estimation calculated using other methods described herein, e.g., the h-loc algorithm described herein. In some embodiments, when a catheter 100 described herein (e.g., a mapping catheter), for example, a catheter 100 comprising one or more reference pairs of coils 310 and electrodes 155, is used to traverse a cardiac chamber to collect information of one or more impedance-based localization fields (e.g., so that the electrodes 155 can be localized as described herein), the system 10 may calculate the mean error of the z-loc estimation. If an error exceeding a threshold is identified (e.g., an error in the z-loc estimation for one or more grid cells of a voxel grid), the system 10 may be configured to update the impedance transformation matrix for the identified grid cells. Figure 12 shows two examples of calculating the mean error, for example, for a catheter 100 comprising a basket-shaped functional assembly 150 having two or more 5-DOF coils 310 (or at least one 6-DOF coil 310), and for a catheter 100 comprising a linear functional assembly 150 having one 5-DOF or 6-DOF coil 310.

[0122] For a catheter 100 comprising a basket-shaped functional assembly 150 having two 5-DOF coils 310, the system 10 can calculate an optimal twist angle based on model fitting and impedance measurements. This optimal twist angle θ ねじれ , the measured catheter orientation θ 方向 , and the measured translation from the magnetic origin

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[0123] Here, R ねじれ is a transformation matrix based on θ ねじれ , R 方向 is a transformation matrix based on θ 方向 , and

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[0124] Similarly, for a catheter 100 having a linear functional assembly 150 including at least one 5-DOF and / or 6-DOF coil 310, the system 10, given the measured catheter orientation, the position of the coil 310, and the identified catheter model, determines the true position of the electrode 155 as described herein.

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[0125] Referring here to Figure 13, a flowchart of a method for compensating for respiratory and cardiac motion, consistent with the concept of the present invention, is shown. Method 5000 in Figure 13 can be carried out using components of System 10 described with reference to Figure 1 and elsewhere in this specification. Both respiratory and / or cardiac motion can introduce undesirable motion artifacts to both the magnetic localization and impedance-based localization methods of System 10 described herein. Such motion can cause artifact motion in the visualization of the localized device (e.g., catheter 100) (e.g., when the localized device is displayed to the user), for example, motion that does not correspond to the true position of the device relative to the cardiac surface. In addition, the measured impedance-based localization information of an electrode (e.g., electrode 155) can fluctuate when the physical position of the electrode is stationary relative to the cardiac surface. This fluctuation can also cause artifact motion of the electrode. For example, such fluctuation may occur during respiration, when the impedance of the human torso increases and decreases as the patient inhales and exhales air, respectively. The overall impedance of the torso changes in proportion to the change in lung volume.

[0126] When localizing a device as described herein, it is essential to eliminate undesirable respiratory and cardiac motion artifacts in order to preserve the true position of the device and maintain navigation accuracy. In some embodiments, respiratory and / or cardiac motion artifacts may affect both magnetic localization and impedance-based information in both the time domain and the frequency domain.

[0127] In some embodiments, system 10 includes one or more respiration and / or cardiac motion compensation algorithms configured to eliminate respiration and / or cardiac motion artifacts in magnetic localization information and / or impedance-based localization information. Compensation for respiration and / or cardiac artifacts can be achieved, for example, by subtracting a signal reconstructed with an orthogonal basis representing the artifacts so that only true catheter motion is retained.

[0128] In some embodiments, cardiac motion artifacts are compensated using a frequency-selective filter. The filter may include spectral characteristics that remove frequencies associated with cardiac motion components in the frequency domain. In some embodiments, the frequency-selective filter may be an FFT low-pass filter that removes frequency components higher than 1 Hz.

[0129] Since respiration and / or cardiac motion can be periodic, or at least quasi-periodic, artifacts in magnetic localization information and / or impedance-based localization information are also periodic. Optimized estimation of respiration and cardiac motion is:

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[0130] In some embodiments, adaptive methods for respiration and cardiac compensation are performed, as shown by method 5000 in Figure 13. The optimal adaptive estimate of the respiration or cardiac component e(t) may be calculated based on a segment of f(t) within a moving window to match changes in respiration and cardiac motion over time. To maintain the orthogonality of the basis for the segment of f(t) within the moving window, the window length N is:

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[0131] In step 5100 of method 5000, system 10 may estimate the respiration and / or cardiac motion components of the localized signal by fitting the input signal to the current set of orthogonal bases. In step 5200, the estimated respiration and / or cardiac motion components of the signal may be compared to a reference signal. In step 5300, the algorithm determines whether the respiration and / or cardiac motion patterns have changed (e.g., whether they have changed since the orthogonal bases were determined). In step 5400, if it is determined that the patterns have changed, the orthogonal bases are updated based on a template respiration and / or cardiac motion signal as described herein, e.g., a signal recorded from coil 41. If the patterns have not changed, in step 5500, the current orthogonal bases may be used and the estimated respiration and / or cardiac motion components may be removed from the localized signal as described herein.

[0132] The embodiments described above should be understood to be for illustrative purposes only, and further embodiments are conceivable. Any feature described herein in relation to any one embodiment may be used alone or in combination with other features described, or in combination with one or more features of any other embodiment, or in any combination of any other embodiment. Furthermore, equivalents and modifications not described above may also be adopted without departing from the scope of the concept of the invention as defined in the appended claims.

Claims

1. A system for performing medical procedures on a patient, wherein the system is A catheter device comprising a distal portion including a distal end, and a functional assembly located in the distal portion of the catheter, wherein the functional assembly comprises one or more electrodes, A console for operating the catheter device, A diagnostic module configured to record signals from at least one of the one or more electrodes, A processing unit configured to process the recorded signal, A console equipped with, A system that includes these features.

2. The system according to claim 1 and / or one or more of the other claims herein, wherein the functional assembly comprises a distal surface, the distal surface including the distal end of the catheter device.

3. The catheter device further comprises a magnetic sensor, according to the system according to claim 1 and / or any one or more of the other claims herein.

4. The system according to claim 3 and / or any one or more of the other claims herein, wherein the magnetic sensor comprises two or more magnetic sensors.

5. The system according to claim 3 and / or any one or more of the other claims herein, wherein the functional assembly comprises the magnetic sensor.

6. The system according to claim 5 and / or any one or more of the other claims herein, wherein the magnetic sensor is configured to provide signals relating to the position, orientation, and / or geometric configuration of the functional assembly.

7. The system according to claim 3 and / or any one or more of the other claims herein, wherein the magnetic sensor includes a five-degree-of-freedom magnetic sensor.

8. The system according to claim 3 and / or any one or more of the other claims herein, wherein the magnetic sensor includes a six-degree-of-freedom magnetic sensor.

9. The system according to claim 1 and / or any one or more of the other claims herein, wherein the functional assembly further comprises a plurality of splines, each spline of the plurality of splines comprising at least one of the one or more electrodes.

10. The system according to claim 9 and / or any one or more of the other claims herein, wherein the plurality of splines comprises at least four splines.

11. The system according to claim 9 and / or any one or more of the other claims herein, wherein the plurality of splines comprises at least eight splines.

12. The system according to claim 9 and / or any one or more of the other claims herein, wherein each of the plurality of splines includes a flat sheet.

13. The system according to claim 9 and / or any one or more of the other claims herein, wherein each of the plurality of splines comprises a material selected from the group consisting of nickel-titanium alloy, stainless steel, polyethyleneimine (PEI), polyimide, and combinations thereof.

14. The system according to claim 9 and / or any one or more of the other claims herein, wherein each of the plurality of splines comprises a first side and a second side.

15. The system according to claim 14 and / or any one or more of the other claims herein, wherein the one or more electrodes comprises a first set of one or more electrodes positioned on the first side of the first spline of the plurality of splines, and a second set of one or more electrodes positioned on the second side of the first spline.

16. The system according to claim 15 and / or any one or more of the other claims herein, wherein each of the first and second sets of one or more electrodes comprises at least three, six, eight, ten, twelve, fourteen, or sixteen electrodes.

17. The system according to claim 15 and / or any one or more of the other claims herein, wherein each electrode of the first set of electrodes comprises a corresponding electrode in the second set of electrodes, and the corresponding electrodes include a pair.

18. The system according to claim 17 and / or any one or more of the other claims herein, wherein each pair of electrodes from the first set of electrodes and the second set of electrodes are aligned axially along the length of the first spline.

19. The system according to claim 17 and / or any one or more of the other claims herein, wherein each pair of electrodes from the first set of electrodes and the second set of electrodes are offset axially along the length of the first spline.

20. The system according to claim 9 and / or any one or more of the other claims herein, further comprising one or more flex circuits, each flex circuit being attached to each spline of the plurality of splines, and each spline comprising at least one of the one or more electrodes.

21. The system according to claim 20 and / or any one or more of the other claims herein, wherein each flex circuit is joined to and / or stacked on the respective spline.

22. The system according to claim 20 and / or any one or more of the other claims herein, wherein each of the plurality of splines comprises a first side and a second side.

23. The system according to claim 22 and / or any one or more of the other claims herein, wherein the one or more flex circuits comprises a first flex circuit attached to the first side of the first spline of the plurality of splines, and a second flex circuit attached to the second side of the first spline.

24. The system according to claim 22 and / or any one or more of the other claims herein, wherein the one or more flex circuits comprises a first flex circuit having a first portion and a second portion, the first portion being attached to the first side of the first spline of the plurality of splines, and the second portion being attached to the second side of the first spline.

25. The system according to claim 22 and / or any one or more of the other claims herein, wherein the plurality of electrodes comprises a first set of one or more electrodes positioned in the first portion of the flex circuit, and a second set of one or more electrodes positioned in the second portion of the flex circuit.

26. The system according to claim 9 and / or any one or more of the other claims herein, further comprising a control assembly having a puller tube, wherein the puller tube is configured to radially expand and / or contract the functional assembly.

27. The system according to claim 26 and / or any one or more of the other claims herein, wherein the control assembly further comprises a housing, the functional assembly comprises a distal end, and the housing connects the puller tube to the distal end of the functional assembly.

28. The housing comprises a first navigation element, the system according to claim 27 and / or any one or more of the other claims herein.

29. The system according to claim 28 and / or any one or more of the other claims herein, wherein the first navigation element comprises a magnetic sensor.

30. The catheter device further comprises a second navigation element, according to the system according to claim 29 and / or any one or more of the other claims herein.

31. The system according to claim 30 and / or any one or more of the other claims herein, wherein the second navigation element comprises a magnetic sensor.

32. The system according to claim 30 and / or any one or more of the other claims herein, wherein the second navigation element is positioned in close proximity to the functional assembly and proximal to the functional assembly.

33. The catheter device further comprises a shaft having a distal end and a coupler housing positioned adjacent to the distal end, wherein the coupler housing connects the functional assembly to the distal end of the shaft, and the second navigation element is positioned within the coupler housing, according to claim 32 and / or any one or more of the other claims herein.

34. The system according to claim 1 and / or any one or more of the other claims herein, wherein the functional assembly includes a diameter of at least 12 mm, 35 mm or less, or both.

35. The system according to claim 1 and / or any one or more of the other claims herein, wherein the one or more electrodes include a material selected from the group consisting of gold, platinum, platinum-iridium, iridium oxide, PDOT conductive polymer, titanium nitride, graphene, precious metal alloys, and combinations thereof.

36. The system according to claim 1 and / or any one or more of the other claims herein, wherein the one or more electrodes include a coating selected from the group consisting of a gold coating, a coating configured to reduce the input impedance of the electrodes, a PDOT coating, an iridium oxide coating, a titanium nitride coating, an oxide coating, and a combination thereof.

37. The catheter device comprises at least a first catheter, and the system is Navigation subsystem, A magnetic-based navigation assembly, (i) A magnetic generator positioned adjacent to the patient's body, wherein the magnetic generator generates a magnetic field, (ii) At least one magnetic sensor coupled to the first catheter and configured to generate a first signal based on the magnetic field, wherein the first signal is associated with the three-dimensional spatial position inside the patient's body, (iii) A magnetic navigation module configured to receive and process the first signal, wherein the magnetic navigation module calculates the three-dimensional spatial position based on the first signal, A magnetic-based navigation assembly comprising, An impedance-based navigation assembly, (i) A plurality of surface patches attached to the patient's body, (ii) An impedance navigation module configured to output a plurality of impedance localization signals on the surface patch to generate a multi-axis impedance localization field, wherein one or more electrodes of the functional assembly are configured to generate one or more second signals correlated to the positions of associated electrodes in the multi-axis impedance localization field, each of the one or more second signals comprising at least magnitude and phase values, and the impedance navigation module further receives and processes the one or more second signals from the one or more electrodes, An impedance-based navigation assembly comprising, A conversion module configured to establish an impedance conversion matrix between the second signal and the three-dimensional spatial position inside the patient's body, based on the first signal and the physical relationship between the at least one magnetic sensor and the one or more electrodes, A navigation subsystem equipped with The system according to claim 1 and / or any one or more of the other claims herein, further comprising:

38. The system according to claim 37 and / or any one or more of the other claims herein, wherein the conversion module is configured to establish a magnetic conversion matrix, and the magnetic navigation module uses the magnetic conversion matrix to calculate the three-dimensional spatial position of the at least one magnetic sensor.

39. The system according to claim 37 and / or any one or more of the other claims herein, wherein the impedance transformation matrix is ​​calibrated by fitting a catheter model template to a three-dimensional spatial position together with a measured impedance field.

40. The catheter model template is derived from mathematical equations based on the position of the at least one magnetic sensor and the physically constrained separation distance and / or orientation of the one or more electrodes of the functional assembly, according to claim 39 and / or any one or more of the other claims herein.

41. The system according to claim 39 and / or any one or more of the other claims herein, wherein the catheter model template is determined from a lookup table of a predefined set of physical measurements.

42. The system according to claim 41 and / or any one or more of the other claims herein, wherein the physical measurements relate to the range of deployment levels of the functional assembly and / or the set of geometric configurations of the functional assembly.

43. The system according to claim 39 and / or any one or more of the other claims herein, wherein the navigation subsystem is configured to calculate the distance and / or angle between two or more of the at least one magnetic sensor, and the navigation subsystem is further configured to calculate the position of one or more of the one or more electrodes based on the calculated distance and / or angle and the catheter model template.

44. The system according to claim 37 and / or any one or more of the other claims herein, wherein the navigation subsystem is configured to assume a nonlinear relationship between the multi-axis impedance localization field and the three-dimensional space within the patient.

45. The navigation subsystem is configured to divide the volume within the patient into a set of cubic voxel cells, the cells establishing a relationship between the second signal and the three-dimensional position of the one or more electrodes, according to claim 37 and / or any one or more of the other claims herein.

46. The system according to claim 45 and / or any one or more of the other claims herein, wherein each of the cubic voxel cells includes a length of at least 2 mm and / or a length of 20 mm or less.

47. The system according to claim 45 and / or any one or more of the other claims herein, wherein the impedance transformation matrix includes a transformation matrix for each cell in the set of cubic voxel cells.

48. The system according to claim 47 and / or any one or more of the other claims herein, wherein the navigation subsystem is further configured to calculate the average error to the cell transformation matrix of the set of cubic voxel cells and to update the transformation matrix if the error exceeds a threshold.

49. The system according to claim 37 and / or any one or more of the other claims herein, wherein the magnetic navigation module is configured to determine the optimal twist angle of the functional assembly.

50. The system according to claim 49 and / or any one or more of the other claims herein, wherein the optimal twist angle is determined based on the first signal from the at least one magnetic sensor.

51. The system according to claim 50 and / or any one or more of the other claims herein, wherein the at least one magnetic sensor comprises at least two magnetic sensors, including a five-degree-of-freedom magnetic sensor.

52. The system according to claim 50 and / or any one or more of the other claims herein, wherein the at least one magnetic sensor includes a six-degree-of-freedom magnetic sensor.

53. The system according to claim 37 and / or any one or more of the other claims herein, wherein the first catheter is at least one of a mapping catheter, an ablation catheter, and / or a diagnostic catheter.

54. The catheter device further comprises at least a second catheter, the second catheter not comprising a magnetic sensor, and the impedance transformation matrix is ​​used to localize the second catheter, according to claim 37 and / or any one or more of the other claims herein.

55. The system according to claim 54 and / or any one or more of the other claims herein, wherein the second catheter comprises at least one of a mapping catheter, an ablation catheter, and / or a diagnostic catheter.

56. The system according to claim 37 and / or any one or more of the other claims herein, wherein each of the plurality of signals has the same or different frequencies.

57. The system according to claim 37 and / or any one or more of the other claims herein, further comprising one or more surface magnetic sensors attached to the patient's skin and configured to generate a third signal, wherein the system is configured to compensate for the patient's body movements based on the third signal.

58. The system according to claim 57 and / or any one or more of the other claims herein, wherein one or more of the plurality of body surface patches each comprises one of the one or more body surface magnetic sensors.

59. The system according to claim 57 and / or any one or more of the other claims herein, wherein the third signal is used to track the movement of the patient's torso relative to the magnetic field generated by the magnetic generator.

60. The system according to claim 57 and / or any one or more of the other claims herein, further configured to construct a mathematical transformation used to remove the body movement component from localization information.

61. The system according to claim 60 and / or any one or more of the other claims herein, wherein the mathematical transformation includes a linear transformation selected from the group consisting of identity, translation, rotation, scaling, shear, and combinations thereof.

62. The system according to claim 61 and / or any one or more of the other claims herein, wherein the conversion includes a scale conversion used by the system to compensate for respiratory motion.

63. The system according to claim 37 and / or any one or more of the other claims herein, wherein the plurality of surface patches and / or the impedance localization signals are configured to avoid null points in the region of interest.

64. The system according to claim 37 and / or any one or more of the other claims herein, further configured to compute data provided as if recorded from one or more virtual electrodes and / or one or more virtual magnetic sensors.

65. The system according to claim 37 and / or any one or more of the other claims herein, wherein the navigation subsystem is configured to determine the expected shape of the functional assembly based on an identified catheter model and the unfolded geometric shape of the functional assembly.

66. The system according to claim 65 and / or any one or more of the other claims herein, wherein the navigation subsystem is further configured to determine the unfolded geometric shape of the functional assembly based on the first signal from the at least one magnetic sensor.

67. The system according to claim 65 and / or any one or more of the other claims herein, further comprising a force sensor configured to measure the deployment force of the functional assembly, wherein the navigation subsystem is further configured to determine the deployment geometric shape based on the deployment force.

68. The navigation subsystem is configured to compensate for respiratory and / or cardiac artifacts by subtracting a signal reconstructed on an orthogonal basis, wherein the signal represents the artifact, as per claim 37 and / or any one or more of the other claims herein.

69. The system according to claim 68 and / or any one or more of the other claims herein, wherein the navigation subsystem is further configured to determine whether the respiratory and / or cardiac movement pattern has changed, and to update the orthogonal basis if the pattern has changed.

70. The system according to claim 69 and / or any one or more of the other claims herein, wherein the orthogonal basis is updated within a time-shift window.

71. The system according to claim 68 and / or any one or more of the other claims herein, wherein the navigation subsystem is further configured to estimate respiration and / or cardiac motion by fitting periodic or quasi-periodic signals to the first and / or second signals.

72. The system according to claim 37 and / or any one or more of the other claims herein, wherein the navigation subsystem is configured to compensate for respiratory and / or cardiac artifacts using a frequency-selective filter.

73. The system according to claim 72 and / or any one or more of the other claims herein, wherein the frequency selection filter removes frequency components higher than 1 Hz.

74. A method for localizing a catheter that does not have a magnetic sensor, wherein the method is (a) The impedance transformation matrix between the measured impedance field and the three-dimensional spatial position inside the patient's body is (i) Inserting a first catheter into the body of the patient, wherein the first catheter comprises a magnetic sensor and a first electrode configured to form a reference pair, (ii) Manipulating the first catheter inside the patient's body while recording a first set of signals from the magnetic sensor and a second set of signals from the first electrode, wherein the first set of signals corresponds to the three-dimensional spatial position of the magnetic sensor inside the patient's body, and (iii) Establishing a dictionary based on the position of the magnetic sensor and the second set of signals recorded from the first electrode. To be established by, (b) storing the dictionary, (c) Position of the second electrode of the second catheter, (i) Record a third set of signals from the second electrode of the second catheter, and (ii) Estimating the position of the second electrode of the second catheter based on the third set of signals and the impedance transformation matrix, and / or using an algorithm that is performed in a global coordinate system defined by the dictionary. To estimate by, Includes, The second catheter does not have a magnetic sensor, The signals of the second set and the signals of the third set include an impedance base signal. method.

75. The method according to claim 74 and / or any one or more of the other claims herein, wherein the second catheter includes an ablation and / or diagnostic catheter.

76. The method according to claim 74 and / or any one or more of the other claims herein, wherein the conversion is used to localize a catheter that does not have a magnetic coil.

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